UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

 

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): February 14, 2019 (February 8, 2019)

 

AMERICAN BRIVISION (HOLDING) CORPORATION
(Exact name of registrant as specified in its charter)

 

Nevada   333-91436   26-0014658
(State or other jurisdiction
of incorporation)
  (Commission File Number)   (IRS Employer
Identification No.)

 

44370 Old Warm Springs Blvd.

Fremont, CA 94538

(Address of principal executive offices) (Zip Code)

 

Registrant’s telephone number, including area code:  (845) 291-1291

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions ( see  General Instruction A.2. below):

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company ☐

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 

 

 

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

 

There are statements in this Current Report on Form 8-K that are not historical facts. These “forward-looking statements” can be identified by use of terminology such as “believe,” “hope,” “may,” “anticipate,” “should,” “intend,” “plan,” “will,” “expect,” “estimate,” “project,” “positioned,” “strategy” and similar expressions. You should be aware that these forward-looking statements are subject to risks and uncertainties that are beyond our control. For a discussion of these risks, you should read this entire Current Report on Form 8-K (including all the contents incorporated by reference) carefully, especially the risks discussed under the section entitled “Risk Factors” which are incorporated by reference. Although management believes that the assumptions underlying the forward looking statements included in this Current Report on Form 8-K are reasonable, they do not guarantee our future performance, and actual results could differ from those contemplated by these forward looking statements. The assumptions used for purposes of the forward-looking statements specified in the following information represent estimates of future events and are subject to uncertainty as to possible changes in economic, legislative, industry and other circumstances. As a result, the identification and interpretation of data and other information and their use in developing and selecting assumptions from and among reasonable alternatives require the exercise of judgment. To the extent that the assumed events do not occur, the outcome may vary substantially from anticipated or projected results, and, accordingly, no opinion is expressed on the achievability of those forward-looking statements. In light of these risks and uncertainties, there can be no assurance that the results and events contemplated by the forward-looking statements contained in this Current Report on Form 8-K will in fact transpire. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of their dates. We do not undertake any obligation to update or revise any forward-looking statements.

 

Item 2.01 Completion of Acquisition or Disposition of Assets.

 

On January 31, 2018, American BriVision (Holding) Corporation (“ABVC”, the “Company” or the “Parent”), BioLite Holding, Inc., a Nevada company (“BioLite”), BioKey, Inc., a California company (“BioKey”), BioLite Acquisition Corp., a Nevada company and direct wholly-owned subsidiary of Parent (“Merger Sub 1”), and BioKey Acquisition Corp., a California company and direct wholly-owned subsidiary of Parent (“Merger Sub 2”) entered into a definitive Agreement and Plan of Merger, providing for the acquisition of BioLite and BioKey by ABVC, which we refer to as the “Merger Agreement.” 

 

On February 8, 2019 (the “Closing Date”), the Company closed the transactions contemplated under the Merger Agreement (the “Closing”), pursuant to which BioLite merged with Merger Sub 1 with BioLite as the surviving corporation, which we refer to as the “BioLite Merger,” and BioKey merged with Merger Sub 2 with BioKey as the surviving corporation, which is referred as the “BioKey Merger.” On the Closing Date, BioLite filed the Article of Merger of the BioLite Merger with the State of Nevada, a copy of which is attached hereto as Exhibit 3.1 , pursuant to which BioLite became a wholly-owned subsidiary of the Company. On the same day, BioKey filed the Agreement of Merger of the BioKey Merger with the State of California, a copy of which is attached hereto as Exhibit 3.2 , pursuant to which BioKey became a wholly-owned subsidiary of the Company. In addition, in accordance with the terms of the Merger Agreement and as consideration for the acquisition of BioLite and BioKey, the Company is in the process of issuing 1.82 shares of its common stock (the “Common Stock”), par value $0.001 per share, for each share of BioLite’s common stock to each BioLite shareholder and one share of its Common Stock for each share of BioKey’s capital stock to each BioKey equity holder. The Company shall issue an aggregate of approximately 104,548,777 shares to both BioLite shareholders and BioKey shareholders, 74,997,546 shares of which will be issued to BioLite shareholders and 29,551,231 shares of which will be issued to BioKey shareholders.

 

The Company registered the shares of the Common Stock to be issued to holders of outstanding shares of BioLite’s common stock and BioKey’s common stock, Series A preferred stock, Series B preferred stock and Series C preferred stock on a Registration Statement on Form S-4 (file number 333-226285), which became effective by operation of law on or about February 5, 2019.

 

Following the Closing, the Company operates as a single entity with three relatively separate but integrated special business units (“SBU”s), which are 1) New Drug Development SBU, including the new drug pipeline products from BioLite and the patented controlled release drug delivery technology from BioKey, 2) Innovative Medical Devices SBU, currently focusing on the development of Vitargus, a new invention of a biocompatible vitreous substitute for the treatment of retinal detachment and vitreous hemorrhage, and 3) CDMO SBU, providing contract services for pharmaceutical companies in the U. S. and as abroad to develop and manufacture new drug products in BioKey’s good manufacturing practice (“GMP”) facility and prepare studies to obtain ANDAs to launch certain new pharmaceutical products in the U.S.  While each of these SBUs is operated independently of one another, they report to the same management team and supervised by the board of directors (the “Board”) of the Company and share common resources and functions, including, but not limited to, administration, accounting, human resources, research and development, business development, legal, manufacturing facilities, and office and laboratory spaces. The new Board has representatives from each board of directors of BioLite, BioKey and ABVC.

 

1

 

 

Tax Treatment

 

Generally

 

The following discussion summarizes the material U.S. federal income tax consequences of the BioLite Merger and BioKey Merger to U.S. holders (as defined below) of BioLite and BioKey capital stock. This discussion is based on the Internal Revenue Code of 1986, as amended (the “Code”), Treasury Regulations, administrative pronouncements and judicial decisions currently in effect, all of which are subject to change, possibly with retroactive effect.  Any such change could affect the accuracy of this discussion.

 

This discussion assumes you hold shares of BioLite or BioKey capital stock as capital assets within the meaning of Section 1221 of the Code.  This discussion does not address all aspects of U.S. federal income taxation that may be relevant to you in light of your particular circumstances or to U.S. holders of BioLite or BioKey capital stock subject to special treatment under the federal income tax laws such as:

 

insurance companies;

 

  investment companies;

 

  tax-exempt organizations;

 

  financial institutions;

 

  dealers in securities or foreign currency;

 

  banks or trusts;

 

 

persons that hold BioLite or BioKey capital stock as part of a straddle, hedge, constructive sale or other integrated security

transaction;

 

  persons that have a functional currency other than the U.S. dollar;

 

  investors in pass-through entities; or

 

 

persons who acquired their BioLite or BioKey capital stock through the exercise of options or otherwise as compensation or

through a tax-qualified retirement plan.

 

Further, this discussion does not consider the potential effects of any state, local or foreign tax laws or U.S. federal tax laws other than federal income tax laws.

 

This discussion is not intended to be tax advice to any particular holder of BioLite or BioKey capital stock.  Tax matters regarding the BioLite and BioKey Mergers are complicated, and the tax consequences of the Mergers to you will depend on your particular situation.  You should consult your own tax advisor regarding the specific tax consequences to you of the Merger, including the applicability and effect of federal, state, local and foreign income and other tax laws.

 

Reporting and Retention Requirements

 

If you receive the merger consideration as a result of the Mergers, you are required to retain certain records pertaining to the Mergers pursuant to the Treasury Regulations under the Code.  If you are a “significant holder” (as defined in the Treasury Regulations under the Code) of BioLite or BioKey capital stock, you must file with your U.S. federal income tax return for the year in which the Mergers take place a statement setting forth certain facts relating to the Mergers.  You are urged to consult your tax advisors concerning potential reporting requirements.

 

Accounting Treatment

 

Due to the fact that ABVC remains control of BioLite and BioKey as a result of the Mergers, the Mergers will be accounted for as a regular acquisition pursuant to which ABVC will be considered the acquiring entity for accounting purposes in accordance with generally accepted accounting principles in the United States of America, referred to as “U.S. GAAP.” 

 

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BUSINESS OF BIOLITE

 

BioLite is a clinical stage pharmaceutical company focused on translational research of botanical and natural APIs based products in the fields of central nervous system, oncology/ hematology and autoimmune diseases. Because BioLite believes natural substances have many healing powers, BioLite focuses its research resources to the development of botanical products, which include plant materials, algae, macroscopic fungi and combinations thereof. BioLite mostly uses traditional cultivation, fermentation and purification techniques, excluding genetic modifications, to process the active natural constituents of its drug candidates. Its operational activities primarily focus on researching and developing novel botanical and natural drugs utilizing scientific methodology and approaches in compliance with the procedures and protocols prescribed by the FDA.

 

BioLite’s research and development team is devoted primarily to preclinical studies, Phase I and II clinical trials of new drug candidates in its fields with goals of translating pharmacology-related research results and theories to medicinal drug candidates that are ready for clinical trials on a large scale, such as Phase III trials, and future commercialization. BioLite through its subsidiaries acquires licenses from universities, government and other research institutes to further preclinical research in order to select new drug candidates for clinical trials, including Phase I and Phase II. BioLite currently focuses on the areas of CNS, oncology/ hematology and autoimmune, where it is seeking to build a portfolio of novel therapeutics that serve large unmet medical needs. As part of the business strategy, BioLite plans to cooperate with well-established pharmaceutical companies in the U.S. and other countries with major medicinal markets to further develop and commercialize its products for which it receives positive clinical trial results from Phase II trials.

 

CNS

 

BioLite through its subsidiary acquired exclusive global rights to develop and license two investigational new drugs to treat central nervous system diseases, both of which are based on novel formulas of extracts from Chinese, Korean and Japanese herbs that have shown promise in treating insomnia, anxiety and other mental disorders. BioLite Taiwan has successfully completed the stage 1, Phase II study of BLI-1005, a novel capsule product to treat major depressive disorder (“MDD”). BioLite is in the process of recruiting sixty patients to carry out the stage 2, Phase II trial of BLI-1005. BLI-1005 is intended to treat MDD and we believe that it offers multiple advantages over currently available antidepressants. The antidepressant market was a 350-million-consumer market globally in 2012 according to a report published by the WHO. In addition, we received from the FDA an approval on the IND application of BLI-1008 for the treatment of attention-deficit hyperactivity disease (“ADHD”) in January 2016 and are scheduled to commence the Phase II trial in the third quarter of 2017, subject to the availability of sufficient funds. BLI-1008 is for the treatment of ADHD, the therapeutics market of which was valued at $3.8 billion in 2010 and was forecast to grow to $7.1 billion by 2018. BLI-1005 and BLI-1008 are two indications deriving from the same API, PDC-1421, as a result of which, BLI-1008 shares the BLI-1005 Phase I clinical trial results. The Phase I clinical trial results of both drug candidates showed no serious adverse events and none of the trial subjects, namely healthy volunteers displayed any signs of suicidal intention or behavior. Suicidal intention and behaviors measure suicidal risks which are related to possibility of serious adverse effects. BioLite has a hypothesis that BLI-1005 and BLI-1008 may be less susceptible to drug abuse and dependence because it thinks both drug candidates will be classified as non-stimulants which are known for low abuse tendency or dependence. Among CNS medications, patients are more likely to abuse psychostimulants, while non-stimulants are considered with less or no potential for abuse. As described above, because atomoxetine (Strattera), a type of non-stimulants, is recognized as with low abuse potential and BLI-1005 acts through the similar mechanism of action as atomoxetine (Strattera), BioLite believes that BLI-1005 may have low abuse or dependence possibility.

 

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Oncology/ Hematology

 

BioLite Taiwan currently has exclusive global rights to develop four innovative botanical drugs, BLI- 1301 to treat Myelodysplastic syndromes (“MDS”), BLI-1401-1 designed to treat solid tumors, BLI-1401-2 TNBC and BLI-1501 intended to treat CLL, all of which constitute our oncology/hematology portfolio. Each of the four investigational new drugs is designed to be used as part of a combination therapy for its targeted cancer because BioLite’s research results indicate each of the four drugs’ ability to improve cancer patients’ immunity and counter the various types of side effects, respectively, caused by the traditional therapies, such as chemotherapies.

  

Myelodysplastic syndromes are a group of cancers in which immature blood cells in the bone marrow do not mature and therefore do not become healthy blood cells. BioLite has received from the FDA an IND approval to conduct Phase II trial of BLI-1301 to treat MDS. A MDS is a relatively rare type of leukemia. About seven (7) per 100,000 people are affected with about four (4) per 100,000 new people being diagnosed with MDS each year. If BioLite can prove to the FDA that BLI-1301 has sufficient potential to treat MDS, BioLite may receive an orphan drug designation for it. As of January 16, 2019, BioLite and ABVC were in the process of recruiting MDS patients globally. Currently BioLite is processing the application for such orphan drug designation for BLI- 1301, which was initiated in 2014.

 

BioLite received the FDA IND approval for BLI-1401-2 for the treatment of TNBC in March 2016 and plan to commence the Phase II trial of such product by the end of 2018 provided that it has sufficient funding for its research and development. BioLite is seeking sourcing providers for BLI-1401-1.

 

BioLite intends to co-develop BLI-1501 with MSKCC with respect to its preclinical studies; however, due to the great number of leukemia-related drugs that MSKCC is researching, the collaboration with MSKCC to develop BLI-1501 is pending.

 

Autoimmune

 

BioLite had a focused pipeline of investigational drugs that are designed for the treatment of autoimmune diseases, including BLI-1006 to treat inflammatory bowel disease (“IBD”) and BLI-1007 for rheumatoid arthritis (“RA”). BioLite received the exclusive global rights on these two autoimmune products from the ITRI in Taiwan which holds patents on both drug candidates in certain Asian, North American and European countries. BioLite conducted the preclinical study on BLI-1006 to prepare for the IND Phase I application thereof. BioLite conducted preclinical studies of BLI-1007 and suspended such studies due to the unpromising results.

 

In the future, BioLite will look to acquire and conduct clinical research on additional investigational botanical new drugs to further the FDA clearance process. BioLite management team’s prior experience has involved screening pre-clinical products, compliance with FDA procedures and identifying co-developers to continue the FDA process and commercialize new drugs.

 

Corporate History and Structure 

 

BioLite, Inc. (“BioLite”) was incorporated under the laws of the state of Nevada on July 27, 2016, with 500,000,000 shares authorized, par value $0.0001. BioLite’s key subsidiaries include BioLite BVI, Inc. (“BioLite BVI”) that was incorporated in the British Virgin Islands on September 13, 2016 and BioLite Taiwan, a Taiwanese corporation that was founded in February 2006. BioLite Taiwan has been in the business of developing new drugs for over ten years.

 

Certain shareholders of BioLite Taiwan exchanged approximately 73% of equity securities in BioLite Taiwan for the common stock in BioLite in accordance with a share purchase/ exchange agreement (the “Share Purchase/ Exchange Agreement”). Pursuant to the Share Purchase/ Exchange Agreement, the shareholder participants to the Share Purchase/ Exchange Agreement sold their equity in BioLite Taiwan and used the proceeds from such sales to purchase shares of common stock of BioLite at the same price per share, resulting in their owning the same number of shares of common stock as they owned in the BioLite Taiwan. After closing of the Share Purchase/ Exchange Agreement, BioLite ultimately owned via BioLite BVI approximately 73% of BioLite Taiwan. The other shareholders who did not enter this Share Purchase/ Exchange Agreement retain their equity ownership in BioLite Taiwan.

 

BioLite’s principal executive office is located at 20 Section 2 Shengyi Rd., 2nd Floor, Zhubei City, Hsinchu County, Taiwan 30261. Our telephone number at our principal executive office is +886-2-7720-8311. Our corporate website is http://biolite.com.tw/en/. The information on our corporate website is not part of, and is not incorporated by reference into, this current report.

 

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BioLite Strategy

 

Key elements of our business strategy include:

 

  Continue Phase II trials of each of BioLite’s investigational new drugs, BLI-1005 for the treatment of MDD, BLI-1008 to treat ADHD, BLI- 1301 to treat Myelodysplastic syndromes, and BLI-1401-2 for the treatment of TNBC.

 

  BioLite prepares the application materials for Phase II trials for BLI-1006 and BLI-1401-1 for which BioLite receive FDA approvals on the respective IND applications.

        

  Continue and complete the orphan drug designation application for BLI- 1301 for the treatment of MDS. If BioLite succeeds in this process, the research and development of BLI- 1301 will switch to a fast track, the process of which is prescribed by the FDA.

 

  Continue the research and development of five of BioLite’s products, which are BLI-1005 for the treatment of MDD, BLI-1008 to treat ADHD, BLI-1401-1 to treat solid tumor, BLI-1401-2 for the treatment of TNBC and BLI- 1301 to treat MDS. In accordance with the ABVC Collaboration Agreement, ABVC committed to developing, distributing and commercializing all and any of the five drug candidates in compliance with the FDA regulations.

 

  Search for additional competent pharmaceutical companies and/or healthcare agencies to cooperate with BioLite to continue post-Phase II trials of its new drugs that will have shown positive trial results and have not been licensed out to ABVC. BioLite plans to identify pharmaceutical companies that are interested in commercializing our investigational new drugs and to work with these co-developers to clear the FDA process.

   

  Screen, identify and acquire additional new drug candidates from research institutions and universities within BioLite’s core botanical drug focus that have shown low or zero toxicity and health benefits in various aspects.

 

  Develop a pipeline of botanical material-based therapeutics, with a focus on identifying novel products with sufficient pre-clinical proof that can potentially serve significant unmet medical needs.

 

BioLite plans to augment its core research and development capability and assets by conducting Phase I and II clinical trials for investigational botanical new drugs in the fields of CNS, hematology/oncology and autoimmune diseases. BioLite has obtained exclusive global rights to eight investigational new drugs from various prestigious research institutions and universities. BioLite intends to seek additional products that are near Phase I trials through licensing, co-development, or collaborative commercial arrangements.

 

BioLite’s management team has extensive experience across a wide range of new drug development and it has in-licensed new drug candidates from large research institutes and universities in both Taiwan and the U.S. Through an assertive product development approach, it expects that it will build a substantial portfolio of oncology/ hematology, CNS and autoimmune products. It believes the initial two phases of clinical trials add great value to investigational new drug development. Because BioLite primarily focuses on Phase I and II research of new drug candidates and out license the post-Phase-II products to capable pharmaceutical companies, BioLite expects to devote substantial efforts and resources to building the disease-specific distribution channels. As a result of its value-added strategy, it currently outsources non-core research activities and collaborates with a few respected CROs so that BioLite can maximize the production of its staff on Phase I and II studies. BioLite expects to continue this strategy which BioLite believes has been effective for the past ten years of its operations.

 

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BioLite Approach

 

BioLite research and development department aims to translating the laboratory research results to new drug candidates ready for Phase III clinical trials together with the CROs that BioLite trusts. Botanical products may be classified as foods, dietary supplements, drugs, medical devices or cosmetics, depending on their “intended use.” There is a fine line separating drugs from foods and dietary supplements. BioLite focuses primarily on developing botanical drugs, which by definition are intended for use in the diagnosis, cure, mitigation or treatment of disease in humans. Together with BioLite’s collaborators and strategic partners, it plans to market, distribute and sell its drug products internationally, in areas such as the United States, Canada and Japan. BioLite needs to have the drug candidates comply with the local authorities regulating drugs and foods, for example the FDA and the Taiwan Food and Drug Administration (“TFDA”), in order to market our drug products in the respective areas. Currently, a lot of countries follow the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (the “ICH”) guidelines that are published by the European Medicines to provide guidance on quality and safety of pharmaceutical development and new drug commercialization among Japan, the United States and Europe. Based on BioLite’s new drug development experience, BioLite made a strategic decision to have its drug candidates go through the FDA process for new drug development first and then seek regulatory approvals on the FDA approved drugs from the authorities equivalent to the FDA in the jurisdictions where BioLite plans to market its new drug products.

 

BioLite business model is based on the NDA procedures and can be summarized as following:

  

 

At Step 1, BioLite reviews the laboratory research results on potential API from research institutions and selects very few API candidates to its new drug portfolio for its translational research. BioLite considers safety, efficacy, patent status and potential markets of new drugs of which the API is a part when it makes the selections for its new drug portfolio. Generally speaking, BioLite filters out the API candidates that are not covered by patents in any jurisdiction.

 

6

 

 

After BioLite licenses an API and relating data and methodology, it simultaneously begins the preclinical development of the API and the patent applications on behalf of the patent owner in the jurisdictions where BioLite and its collaborators may in the future market the new drug of which the API is a key component. Preclinical development, also named preclinical studies and nonclinical studies, is a stage of research that precedes clinical trials which are testing on humans, and during which important feasibility, iterative and drug safety data are collected. The main goals of preclinical studies are to determine the safe dose for a first-in-man study and assess a drug’s safety profile. New drug candidates may undergo pharmacodynamics (what the drug does to the body), pharmacokinetics (what the body does to the drug), absorption, distribution, metabolism, and excretion (“ADME”) and toxicology testing. This data allows researchers to allometrically estimate a safe starting dose of the drug candidate for clinical trials in humans. Most preclinical studies must adhere to GLPs in ICH Guidelines to be acceptable for submission to the FDA. Studies of a drug’s toxicity include which organs are targeted by that drug, as well as if there are any long-term carcinogenic effects or toxic effects on mammalian reproduction. After the non-animal preclinical studies, if BioLite decides to proceed on this drug candidate, it will conduct animal testing of this drug candidate on at least two mammalian species, including one non-rodent species, in compliance with the FDA guidelines.

 

If the preclinical studies meet the regulatory requirements and BioLite’s expectations, it will start preparing an IND submission for Phase 1 clinical studies. The amount of information needed for Phase 1 IND application depends on various factors unique to the drug candidate but generally an IND submission includes a description of the new drug candidate (covering botanical raw materials used and known active constituents or chemical constituents), prior human use experience, CMC of the new drug candidate, placebos, environmental assessment, non-clinical pharmacology and toxicology, clinical pharmacology and other clinical considerations. After the approval of IND for Phase I, BioLite will begin on the Phase I clinical research, which consists of two stages, safety and dosage. BioLite may recruit a small number of people, from 20 to 100 healthy volunteers or people with the disease, to participate in Phase 1, which may continue for several months. If the Phase I results meet our goals, BioLite will start the IND application for Phase II trials, which include the data collected from the Phase I studies and preclinical research. Phase II trials focus on efficacy and side effects of the new drug candidates. Phase II clinical trials may involve up to several hundred human participants, last for a couple of years and require more resources than Phase I does.

 

Due to the limited size of BioLite’s research and development team and equipment, BioLite frequently outsources preclinical development, Phase I and II clinical trials and data analysis to our trusted co-developers or CROs, such as Amarex Clinical Research LLC (“Amarex”), a limited liability company with primary offices in Maryland. We have been collaborating with each of these CROs for a substantial period of time. During the development of BioLite’s drug candidates, BioLite identifies and secures partners to collaborate on the clinical trials and conduct post-Phase II testing. BioLite generally enters into collaboration agreements with its collaborators and receives milestone payments for licensing out its research results on its drug candidates. BioLite’s collaborators will either continue post-Phase II large-scaled clinical trials and commercialize the new drugs independently or find appropriate pharmaceutical companies to co-develop the drug candidates.

 

 

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BioLite Product Pipeline and the Markets

 

The table below provides a snapshot of development stage of each drug candidate in BioLite pipeline. As stated above, BioLite Taiwan licensed out the Products to ABVC in 2015. Details about the studies on each of BioLite’s drug candidates are described after the table.

 

Project Name   Indication   Current Development Status
BLI-005   Major Depressive Disorder   Successfully completed Phase I clinical study in 2013;
        Received protocol approval for Phase II trial from the FDA in March 2014;
        Received protocol approval for Phase II trial from Taiwan F.D.A. in June 2014;
        Conducting Phase II Part 2 trial studies in both Taiwan and a site in California, U.S.
BLI-1006   Inflammatory Bowel Disease  

Conduct protocal design of the Phase I trial and prepare the IND Phase I trial application.

Wait for the raw material of the drug candidate.

BLI-1007   Rheumatoid Arthritis   Suspended.
BLI-1008     Attention-Deficit Hyperactivity Disease   Received an IND approval from the FDA to conduct Phase II clinical trials in January 2016;
        Established a trial site at the University of California, San Francisco and intended to start the Phase II trial in 2019;
BLI-1301     Myelodysplastic Syndromes   Submitted an application for the orphan drug designation to the FDA in January 2014;
        Received an IND approval from the FDA in 2016;
        Recruit patients with MDS and plan to initiate the Phase II trial in the fourth quarter of 2018 if we recruit enough patients.
BLI-1401-1     Solid Tumors   Wait for sourcing providers of BLI-1401-1.
BLI-1401-2     Triple Negative Breast Cancer   Received an IND approval from FDA to conduct Phase II studies in 2016.
        Plan to commence Phase I trial in the fourth quarter of 2018.
BLI-1501     Chronic Lymphocytic Leukemia   Wait for the source of one of the ingredients of BLI-1501’s API.

 

Collaboration and Licensing Status

 

As part of BioLite strategy and business model, BioLite obtains licenses of APIs, surrounding technologies and proprietary data from research institutions, conducts the preclinical and Phase I and II clinical research and license out the research results to collaborators to further develop and commercialize the new drug candidates. The illustration shows the licensing status of BioLite’s drug candidates.

 

Project Name   Indication   Source of Technology (Licensor)   Sub-licensee   Licensee’s
Territories
BLI-1005   Major Depressive Disorder   Medical and Pharmaceutical Industry Technology and Development Center (“MPITDC”)   ABVC   The United States and Canada
            BioHopeKing   Asia excluding Japan
BLI-1006   Inflammatory Bowel Disease   Industrial Technology Research Institute (“ITRI”)   BioHopeKing   Worldwide
BLI-1007   Rheumatoid arthritis   ITRI   n/a   n/a
BLI-1008   Attention-Deficit Hyperactivity disease   MPITDC   ABVC   The United States and Canada
BLI-1301   Myelodysplastic Syndromes   Yukiguni   ABVC   Worldwide
BLI-1401-1   Solid Tumors   Yukiguni   ABVC   The United States and Canada
BLI-1401-2   Triple Negative Breast Cancer   Yukiguni   ABVC   The United States and Canada
            BioHopeKing   Asia excluding Japan
BLI-1501   Chronic Lymphocytic Leukemia   n/a   ABVC   The United States and Canada

  

  License-In

 

8

 

 

On January 1, 2011, BioLite Taiwan entered into a license agreement with MPITDC (the “MPITDC License Agreement”) pursuant to which BioLite Taiwan obtained from MPITDC the exclusive global rights to PDC-1421, an API, and its surrounding proprietary information to develop, manufacture, distribute and sell pharmaceutical products. However, if BioLite Taiwan want to use, develop, manufacture, distribute or sell pharmaceutical products that contain PDC-1421 as the API outside Taiwan, BioLite Taiwan need to obtain written consent from MPITDC which will make sure such intended action complies with Taiwanese laws and regulations, particularly on scientific research development. With PDC-1421 as the API, BioLite Taiwan are developing two new drug candidates, BLI-1005 to treat MDD and BLI-1008 for ADHD. In accordance with the terms and conditions of the MPITDC License Agreement, BioLite Taiwan shall pay a license fee of NTD 17,000,000 (approximately $563,894) to MPITDC on a schedule dictated by the time when we reach certain milestones, a royalty fee of 3% of net sales of our products containing PDC-1421 as the API in the territories which MPITDC’s patents cover (the “MPITDC’s Patent Territories”) and 1% of the net sales of our products containing PDC-1421 as the API in the territories for which MPITDC’s patents are not covered (the “MPITDC’s Non-patent Territories”) during the term of the MPITDC License Agreement. The MPITDC License Agreement provides MPITDC a ten per cent (10%) of the net income from BioLite Taiwan’s sublicensing of therapeutic products derived from PDC-1421 (deducting all development related expenses, such as compliance expenses, travel expenses and taxes) when BioLite Taiwan relicenses the proprietary data relating to PDC-1421 to a collaborator or third party. The MPITDC License Agreement will expire when the last patent licensed to us expires in November 2026. As of today, according to the MPITDC License Agreement, BioLite Taiwan has directed BioHopeKing, the sublicensee of PDC-1421, to transfer 10,049 and 15,073 shares of BioHopeKing’s common stock owned by us to National Science and Technology Development Fund and ITRI, respectively. BioLite Taiwan paid MPITDC the upfront payment of $105,500 in 2011, the first milestone payment of $79,100 in 2012 and the third milestone payment of 65,940 in 2013. Because BioLite Taiwan received revenue from our collaboration agreements with BioHopeKing and ABVC as described below, BioLite Taiwan has accrued 10% of the net sublicensing income payable to MPITDC pursuant to the MPITDC License Agreement.

 

On February 10, 2011, BioLite Taiwan entered into a license agreement with ITRI (the “ITRI BLI-1006 License Agreement”) pursuant to which we obtained from ITRI the global rights to BEL-DLS01, an API intended to treat inflammatory bowel diseases, and its surrounding proprietary information and platforms to develop, modify, manufacture, distribute and sell pharmaceutical products. With BEL-DLS01 as the API, BioLite Taiwan is developing BLI-1006 to treat inflammatory bowel disease. In accordance with the terms and conditions of the ITRI BLI-1006 License Agreement, BioLite Taiwan shall pay license fees of an aggregate amount of NTD 20,000,000 (approximately $663,405) to ITRI on a schedule of six stages dictated by the time when BioLite Taiwan reaches certain milestones. In addition, BioLite Taiwan shall pay a royalty fee ranging from three to five per cent (3-5%) of the net sales of the medicinal products in various territories during the term of the ITRI License Agreement. The ITRI License Agreement provides ITRI ten per cent (10%) of the net income from BioLite Taiwan’s sublicensing of therapeutic products derived from BEL-DLS01 when BioLite Taiwan sub-licenses or relicenses its proprietary data about BEL-DLS01 to a collaborator or third party. The ITRI BLI-1006 License Agreement will expire on the later date of the last expiry of all the patents licensed in the Agreement or February 9, 2031. As of January 16, 2019, according to the ITRI License Agreement, BioLite Taiwan directed BioHopeKing, the sublicensee of BEL-DLS01, to transfer 16,667 and 16,666 shares of BioHopeKing’s common stock owned by us to National Science and Technology Development Fund and ITRI, respectively. BioLite Taiwan paid ITRI the upfront payment of $105,500 in 2011, the first milestone payment of $79,100 in 2012 and the third milestone payment of 65,940 in 2013. Because BioLite Taiwan received revenue from its collaboration agreement with ABVC to develop BLI-1006 as described below, BioLite Taiwan has accrued 10% of the net sublicensing income payable to ITRI under the ITRI License Agreement.

 

On February 10, 2011, BioLite Taiwan entered into another license agreement with ITRI (the “ITRI BLI-1007 License Agreement”) pursuant to which ITRI granted us non-exclusive licensing rights to use, modify and manufacture BEL-DLS03, an API designed to treat rheumatoid arthritis, and its analysis platform for therapeutic and dietary purposes. ITRI and BioLite Taiwan agreed to modify the ITRI BLI-1007 License Agreement and on September 10, 2016, executed an amendment (the “ITRI BLI-1007 License Agreement Amendment”) to change primarily the terms of milestone payments and royalty fees. In accordance with the ITRI BLI-1007 License Agreement and its Amendment, ITRI licensed to us an exclusive licensing right to use its patent of BEL-DLS03 and its manufacturing method (the “BEL-DLS03 Patent”). In exchange for the licensed rights, BioLite Taiwan agreed to pay an aggregate amount of 3.5 million NTD (approximately $114,900) to ITRI as listed in the table below, which was paid in full upon execution of the said Agreement. BioLite Taiwan shall pay ITRI ten per cent (10%) of the net income from sublicensing the BEL-DLS03 Patent and royalties based on the net sales of BLI-1007 in various patent-protected and non-patent-protected jurisdictions. The ITRI BLI-1007 License Agreement will expire on the later date of the last expiration date of the BEL-DLS03 patent or February 9, 2031. At this stage, BioLite Taiwan was conducting preclinical studies of BEL-DLS03, which is the API for our drug candidate BLI-1007. As of January 16, 2019, BioLite did not sublicense BLI-1007 and the relating data and technologies to any other organizations.

 

On May 10, 2013, BioLite Taiwan entered into the Yukiguni License Agreement with Yukiguni, pursuant to which BioLite Taiwan obtained from Yukiguni the exclusive rights to develop therapeutic use of Yukiguni Maitake Extract 404, an API that has shown promise to treat various types of cancers, in Asia excluding Japan. Later on December 27, 2016, BioLite Taiwan terminated the Yukiguni License Agreement and entered into a new license agreement (the “Yukiguni License Agreement 2”) to adjust to changes of new drug development and business situations. Under the new agreement, BioLite Taiwan has obtained the exclusive and sublicensable right to develop therapeutic use of the API for cancer treatment and non-exclusive sublicensable right to develop therapeutic use of the API for treatments not related to cancers. BioLite Taiwan’s license rights are royalty free and global and in exchange for such licensing, BioLite Taiwan shall pay Yukiguni an aggregate of $305,000 in stages according to a milestone schedule, which as of December 31, 2016, BioLite Taiwan was not obligated to pay because Yukiguni did not reach any milestone set forth therein. Pursuant to the Yukiguni License Agreement 2, BioLite Taiwan agrees to purchase first from Yukiguni all the Yukiguni Maitake Extract 404 that BioLite Taiwan needs to develop our related therapeutic products, which currently include BLI-1301, BLI-1401-1 and BLI-1401-2 and Yukiguni represents that it will provide sufficient quantities of such API. The initial term of Yukiguni License Agreement 2 is twenty years from the execution date or fifteen years from the first sale of the therapeutic product, whichever happens earlier, with an automatic renewal of another five year period unless BioLite Taiwan or Yukiguni terminates the Agreement pursuant to the termination clauses included therein. BioLite Taiwan agreea to subject its sublicenses that involve Yukiguni Maitake Extract 404 to the expiration terms of the Yukiguni License Agreement 2, excluding the termination terms of such Agreement.

 

9

 

 

The following table summarizes BioLite Taiwan’s obligations respecting the milestone payments and royalty fees generated by commercialization of each licensed drug candidate in accordance with the terms of the four licensing agreements, as amended, entered by BioLite Taiwan with three respective licensors as described above.

 

API Licensor/
Payee of
Milestone
Payments
and
Royalties
Indications
Developed
from the
API
Development or Regulatory Milestone Payments to Licensors Royalty Payments
After
Commercialization
            Total
Milestone
Payments
 
PDC-1421
and relating
technologies
and research
data
MPITDC BLI-1005 20% of the
total
payments
upon
15% of the
total
payments
upon
12.5% of the
total
payments
upon
7.5% of the
total
payments
upon
15% of the
total
payments
upon
30% of the
total
payments
17 million NTD
(approximately
$563,894)
3% of our net sales
in the territories
where MPITDC
has patents; 1% of
    BLI-1008 execution of
the license
agreement
submission of
IND for Phase
I trial of BLI-
1005
completion of
Phase I of
BLI-1005
completion of
Phase II of
BLI-1005
completion of
Phase III of
BLI-1005
upon IND
submission of
BLI-1005
  our net sales in the
territories where
MPITDC does not
own patents [1]
BEL-
DLS01
ITRI BLI-1006 approximately
$65,735 paid
upon
execution of
the license
agreement
approximately
$65,735 upon
submission of
IND for Phase
I trial of BLI-
1006
approximately $65,735 upon
submission of
IND for Phase
II trial of
BLI-1006
approximately
$98,495 upon
submission of
IND for Phase
III trial of
BLI-1006
approximately $164,157
upon
submission of
NDA of BLI-
1006
approximately
$196,989
upon approval
of BLI-1006
20 million NTD
(approximately
$663,405)
3-5% of our net
sales in the
territories where
ITRI has patents;
3% of our net sales
in the territories
where ITRI does
not own patents [2]
BEL-
DLS03
ITRI BLI-1007 approximately
$114,900 paid
upon
execution of
the license
agreement
    n/a     3.5 million
NTD
(approximately
$114,900)
3.5-5.5% of our net
sales in the
territories where
ITRI has patents;
3.5% of our net
sales in the
territories where
ITRI does not own
patents; 10% of the
net proceeds from
sublicensing ITRI’s
patents on BLI-1007 [3]
Yukiguni
Maitake
Extract 404
and relating
Yukiguni BLI-1301             $305,000  
technologies
and data
  BLI-1401-1 $152,500
(payable upon
Phase II IND
submission of
BLI-1301)
$91,500 (payable upon Phase II IND
submission of BLI-1301)
$61,000 (payable upon the
first NDA submission of
BLI-1301)
  none
    BLI-1401-2                
                     

 

[1] In accordance with MPITDC License Agreement, the royalty payments will cease on November 19, 2026, which is the last expiry date of the patent licensed to us respecting PDC-1421, the API of both BLI-1005 and BLI-1008.

 

[2] In accordance with ITRI BLI-1006 License Agreement, the royalty payments will cease on February 10, 2031, which is the last expiry date of the patent licensed to us respecting BEL- DLS01, the API of BLI-1006.

 

[3] In accordance with ITRI BLI-1007 License Agreement, the royalty payments will cease on December 26, 2033, which is the last expiry date of the patent licensed to us respecting BEL- DLS03, the API of BLI-1007.

 

  License-Out

 

10

 

 

On February 24, 2015, BioLite Taiwan and BioHopeKing entered into a co-development agreement (the “BioHopeKing Collaboration Agreement for BLI-1401-2”) pursuant to which BioLite Taiwan granted BioHopeKing the rights to use proprietary technology, data and intellectual property of our project BLI-1401-2 to develop and commercialize the combination therapy to treat triple negative breast cancer in Asian countries excluding Japan. Later on July 27, 2016, BioLite Taiwan and BioHopeKing agreed to an addendum (the “BioHopeKing Addendum”) to revise the milestone payment schedule. In accordance with the terms of the BioHopeKing Collaboration Agreement for BLI-1401-2 and the Addendum thereto, BioLite Taiwan may expect to receive payments of a total of $10 million in cash and equity of BioHopeKing or equity securities owned by it at various stages on a schedule dictated by BioLite Taiwan’s achievements of certain milestones and twelve per cent (12%) of net sales of the drug products when BLI-1401-2 is approved for sale in the licensed territories. BioHopeKing and BioLite Taiwan shall share the development costs of BLI-1401-2 equally. BioLite Taiwan received $1 million from BioHopeKing upon execution of the said agreement in 2015 and the first development milestone payment of $983,008 in 2016. The BioHopeKing Collaboration Agreement for BLI-1401-2 shall expire fifteen (15) years from the first commercial sale of the BLI-1401-2 if approved by the local regulatory authorities and may be renewed for another five years without notice.

 

On December 8, 2015, BioLite Taiwan and BioHopeKing entered into a co-development agreement (the “BioHopeKing Collaboration Agreement for BLI-1005”) pursuant to which BioLite Taiwan granted BioHopeKing the rights to use proprietary technology, data and intellectual property of BioLite Taiwan’s project BLI-1005 to develop and commercialize the medicinal therapy to treat major depressive disorder in Asian countries, excluding Japan. In accordance with the terms of the BioHopeKing Collaboration Agreement for BLI-1005, BioLite Taiwan received a payment of a total of NTD thirty (30) million (equal to approximately $995,107) in cash upon signing the said agreement and expect to receive fifty per cent (50%) of net sublicensing income or net sales of the drug products in the licensed territories. BioHopeKing and BioLite Taiwan shall share the development cost of BLI-1005 equally. The BioHopeKing Collaboration Agreement for BLI-1005 shall expire fifteen (15) years from the first commercial sale of the BLI-1005 if approved by the local regulatory agencies and may be renewed for another five years without notice.

 

On December 8, 2015, BioLite Taiwan and BioHopeKing entered into another co-development agreement (the “BioHopeKing Collaboration Agreement for BLI-1006”) pursuant to which BioLite Taiwan granted BioHopeKing the global rights to use our proprietary technology, data and intellectual property of BioLite Taiwan’s project BLI-1006 to develop and commercialize the therapeutic treatment for inflammatory bowel disease. In accordance with the terms of the BioHopeKing Collaboration Agreement for BLI-1006, BioLite Taiwan received a payment of NTD twenty (20) million (equal to approximately $663,405) in cash upon execution of the said agreement and can expect to receive fifty per cent (50%) of net sublicensing income or net sales of the drug products globally. BioHopeKing and BioLite Taiwan shall share the development cost of BLI-1006 equally. The BioHopeKing Collaboration Agreement for BLI-1006 shall expire fifteen (15) years from the first commercial sale of the BLI-1006 if approved by the local regulatory agencies and may be renewed for another five years without notice.

 

On May 21, 2018, BioLite Taiwan and BioHopeKing mutually amended the BioHopeKing Collaboration Agreement for BLI-1006 by entering into the Amendment One to replace BLI-1006 with BLI-1008 for ADHD. Pursuant to Amendment One, BioLite Taiwan granted BioHopeKing the rights to use its proprietary technology, data and intellectual property of BioLite Taiwan’s project BLI-1008 to develop and commercialize the therapeutic treatment for ADHD in Asia, excluding Japan. The rest of the terms of the BioHopeKing Collaboration Agreement remain unchanged.

 

11

 

 

The following table summarizes BioLite Taiwan’s milestone payments, received or expected to receive from BioHopeKing, in accordance with the terms of three collaboration agreements entered by and between BioLite Taiwan and BioHopeKing as described above.

 

Payments From BioHopeKing

Product code 

(Territory)

 

Development or Regulatory Milestone Payments Royalty Payments
After
Commercialization
2015 2016

2017

(estimated)

2018 (estimated) 2019 (estimated) 2020 (estimated)  

BLI-1401-2

(Asia excluding Japan)

 

$1,000,000 (received upon execution of the collaboration agreement) $983,008 (received upon the IND submission for Phase I clinical trials) n/a $1,000,000 (receivable upon completion of the stage 1Phase II trials) $3,000,000 (receivable upon initiation of Phase III trials) $4,000,000 (receivable upon NDA submission)

12% of the net sales

[1]

BLI-1005

(Asia excluding Japan)

 

$995,107 (received upon execution of the collaboration agreement) n/a 50% of net licensing income or net profits from sales [2]

BLI-1006

(Worldwide)

later replaced by BLI-1008

 

$663,405 (received upon execution of the collaboration agreement) n/a

50%

Net Income

 [3]

 

[1] In accordance with the BioHopeKing Collaboration Agreement for BLI-1401-2, the royalty payments to us shall cease on the fifteenth anniversary of the first commercial sale of BLI-1401-2 with the potential of a five-year extension without notice from either party of such agreement.

 

[2] In accordance with the BioHopeKing Collaboration Agreement for BLI-1005, the royalty payments to us shall cease on the fifteenth anniversary of the first commercial sale of BLI-1005 with the potential of a five-year extension without notice from either party of such agreement.

 

[3] In accordance with the BioHopeKing Collaboration Agreement for BLI-1006, the royalty payments to us shall cease on the fifteenth anniversary of the first commercial sale of BLI-1006 with the potential of a five-year extension without notice from either party of such agreement.

 

As described in the business section of ABVC, BioLite Taiwan and BriVision entered into the ABVC Collaboration Agreement, Addendum and Milestone Payments, pursuant to which BioLite Taiwan and BriVision shall co-develop and commercialize in the territories of the U.S. and Canada the Products. Because BioLite Taiwan and BriVision are considered related parties under common control through their respective holding companies, BioLite does not recognize the proceeds that BriVision received and expects to receive under the ABVC Collaboration Agreement, as amended, as revenues of BioLite in accordance with GAAP.

 

Patents and Proprietary Rights

 

BioLite obtains licenses from research institutions to translate the scientific results to therapeutics and as a result BioLite does not own any patent at this time and may develop and execute patents on its own if it makes discoveries or inventions during the operations. As of January 16, 2019, approximately 39 patents covering BioLite’s drug candidates existed and remained valid or were pending in various jurisdiction as registered. The respective licensors of BioLite’s drug candidates own those patents.

 

12

 

 

Government Regulations

 

While BioLite is developing pharmaceutical candidates as of January 16, 2019, it may in the future acquire more proprietary technologies to expand its drug candidate portfolio. Currently, BioLite is developing eight therapeutic candidates in the fields of CNS, oncology/hematology and autoimmune, for which regulatory approval must be received before it can market and sell them. Regulatory approval processes for BioLite’s current and any future product candidates are discussed below.

 

Approval Process for Pharmaceutical Products

 

FDA Approval Process for Pharmaceutical Products

 

In the U.S., pharmaceutical products are subject to extensive regulation by the FDA. The FDC Act, and other federal and state statutes and regulations, govern, among other things, the research, development, testing, manufacture, storage, recordkeeping, approval, labeling, promotion and marketing, distribution, post-approval monitoring and reporting, sampling, and import and export of pharmaceutical products. Failure to comply with applicable U.S. requirements may subject a company to a variety of administrative or judicial sanctions, such as FDA refusal to approve pending NDAs, warning letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, civil penalties, and criminal prosecution. Pharmaceutical product development in the U.S. typically involves the performance of satisfactory nonclinical, also referred to as pre-clinical, laboratory and animal studies under the FDA’s Good Laboratory Practice, or GLP, regulation, the development and demonstration of manufacturing processes, which conform to FDA mandated current good manufacturing requirements, or cGMP, including a quality system regulating manufacturing, the submission and acceptance of an IND application, which must become effective before human clinical trials may begin in the U.S., obtaining the approval of Institutional Review Boards, or IRBs, at each site where we plan to conduct a clinical trial to protect the welfare and rights of human subjects in clinical trials, adequate and well-controlled clinical trials to establish the safety and effectiveness of the drug for each indication for which FDA approval is sought, and the submission to the FDA for review and approval of an NDA. Satisfaction of FDA requirements typically takes many years and the actual time required may vary substantially based upon the type, complexity, and novelty of the product or disease.

 

Pre-clinical tests generally include laboratory evaluation of a product candidate, its chemistry, formulation, stability and toxicity, as well as certain animal studies to assess its potential safety and efficacy. Results of these pre-clinical tests, together with chemistry, manufacturing controls and analytical data and the clinical trial protocol, which details the objectives of the trial, the parameters to be used in monitoring safety, and the effectiveness criteria to be evaluated, along with other requirements must be submitted to the FDA as part of an IND, which must become effective before human clinical trials can begin. The entire clinical trial and its protocol must be in compliance with what are referred to as good clinical practice, or GCP, requirements. The term, GCP, is used to refer to various FDA laws and regulations, as well as international scientific standards intended to protect the rights, health and safety of patients, define the roles of clinical trial sponsors and assure the integrity of clinical trial data.

 

An IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day time period, raises concerns or questions about the intended conduct of the trials and imposes what is referred to as a clinical hold. Pre-clinical studies generally take several years to complete, and there is no guarantee that an IND based on those studies will become effective, allowing clinical testing to begin. In addition to FDA review of an IND, each medical site that desires to participate in a proposed clinical trial must have the protocol reviewed and approved by an independent IRB or Ethics Committee, or EC. The IRB considers, among other things, ethical factors, and the selection and safety of human subjects. Clinical trials must be conducted in accordance with the FDA’s GCP requirements. The FDA and/or IRB may order the temporary, or permanent, discontinuation of a clinical trial or that a specific clinical trial site be halted at any time, or impose other sanctions for failure to comply with requirements under the appropriate entity jurisdiction.

 

Clinical trials to support NDAs for marketing approval are typically conducted in three sequential phases, but the phases may overlap. In Phase 1 clinical trials, a product candidate is typically introduced either into healthy human subjects or patients with the medical condition for which the new drug is intended to be used.

 

The main purpose of the trial is to assess a product candidate’s safety and the ability of the human body to tolerate the product candidate. Phase 1 clinical trials generally include less than 50 subjects or patients. During Phase 2 trials, a product candidate is studied in an exploratory trial or trials in a limited number of patients with the disease or medical condition for which it is intended to be used in order to: (i) further identify any possible adverse side effects and safety risks, (ii) assess the preliminary or potential efficacy of the product candidate for specific target diseases or medical conditions, and (iii) assess dosage tolerance and determine the optimal dose for Phase 3 trials. Phase 3 trials are generally undertaken to demonstrate clinical efficacy and to further test for safety in an expanded patient population with the goal of evaluating the overall risk-benefit relationship of the product candidate. Phase 3 trials are generally designed to reach a specific goal or endpoint, the achievement of which is intended to demonstrate the candidate product’s clinical efficacy and adequate information for labeling of the approved drug.

 

13

 

 

The FDA has 60 days from its receipt of an NDA to determine whether the application will be accepted for filing based on the FDA’s threshold determination that it is sufficiently complete to permit substantive review. Once the submission is accepted for filing, the FDA begins an in-depth review. The FDA has agreed to certain performance goals in the review of NDAs. Most such applications for standard review drug products are reviewed within ten months; most applications for priority review drugs are reviewed in six months. Priority review can be applied to drugs that the FDA determines offer major advances in treatment, or provide a treatment where no adequate therapy exists. The review process for both standard and priority review may be extended by the FDA for three additional months to consider certain late-submitted information, or information intended to clarify information already provided in the submission. The FDA may also refer applications for novel drug products, or drug products which present difficult questions of safety or efficacy, to an advisory committee — typically a panel that includes clinicians and other experts — for review, evaluation, and a recommendation as to whether the application should be approved. The FDA is not bound by the recommendation of an advisory committee, but it generally follows such recommendations. Before approving an NDA, the FDA will typically inspect one or more clinical sites to assure compliance with GCP. Additionally, the FDA will inspect the facility or the facilities at which the drug is manufactured. The FDA will not approve the product unless compliance with cGMP is satisfactory and the NDA contains data that provide substantial evidence that the drug is safe and effective in the indication studied. 

 

After the FDA evaluates the NDA and the manufacturing facilities, it issues either an approval letter or a complete response letter. A complete response letter generally outlines the deficiencies in the submission and may require substantial additional testing or information in order for the FDA to reconsider the application. If and when those deficiencies have been addressed to the FDA’s satisfaction in a resubmission of the NDA, the FDA will issue an approval letter. The FDA has committed to reviewing such resubmissions in two or six months depending on the type of information included. An approval letter authorizes commercial marketing of the drug with specific prescribing information for specific indications. As a condition of NDA approval, the FDA may require a risk evaluation and mitigation strategy, or REMS, to help ensure that the benefits of the drug outweigh the potential risks.

 

REMS can include medication guides, communication plans for healthcare professionals, and elements to assure safe use, or ETASU. ETASU can include, but are not limited to, special training or certification for prescribing or dispensing, dispensing only under certain circumstances, special monitoring, and the use of patient registries. The requirement for a REMS can materially affect the potential market and profitability of the drug. Moreover, product approval may require substantial post-approval testing and surveillance to monitor the drug’s safety or efficacy. Once granted, product approvals may be withdrawn if compliance with regulatory standards is not maintained or problems are identified following initial marketing.

 

Post-Approval Regulation

 

Even if a product candidate receives regulatory approval, the approval is typically limited to specific clinical indications. Further, even after regulatory approval is obtained, subsequent discovery of previously unknown problems with a product may result in restrictions on its use or even complete withdrawal of the product from the market. Any FDA-approved products manufactured or distributed by us are subject to continuing regulation by the FDA, including record-keeping requirements and reporting of adverse events or experiences. Further, drug manufacturers and their subcontractors are required to register their establishments with the FDA and state agencies, and are subject to periodic inspections by the FDA and state agencies for compliance with cGMP, which impose rigorous procedural and documentation requirements upon us and our contract manufacturers. BioLite cannot be certain that BioLite or its present or future contract manufacturers or suppliers will be able to comply with cGMP regulations and other FDA regulatory requirements. Failure to comply with these requirements may result in, among other things, total or partial suspension of production activities, failure of the FDA to grant approval for marketing, and withdrawal, suspension, or revocation of marketing approvals.

 

14

 

 

If the FDA approves one or more of our product candidates, BioLite and the contract manufacturers BioLite uses for manufacture of clinical supplies and commercial supplies must provide certain updated safety and efficacy information. Product changes, as well as certain changes in the manufacturing process or facilities where the manufacturing occurs or other post-approval changes may necessitate additional FDA review and approval. The labeling, advertising, promotion, marketing and distribution of a drug must be in compliance with FDA and Federal Trade Commission, or FTC, requirements which include, among others, standards and regulations for direct-to-consumer advertising, off-label promotion, industry sponsored scientific and educational activities, and promotional activities involving the Internet. The FDA and FTC have very broad enforcement authority, and failure to abide by these regulations can result in penalties, including the issuance of a warning letter directing us to correct deviations from regulatory standards and enforcement actions that can include seizures, fines, injunctions and criminal prosecution.

 

Foreign Regulatory Approval

 

Outside of the U.S., BioLite’s ability to market our product candidates will be contingent also upon its receiving marketing authorizations from the appropriate foreign regulatory authorities, whether or not FDA approval has been obtained. The foreign regulatory approval process in most industrialized countries generally encompasses risks similar to those BioLite will encounter in the FDA approval process. The requirements governing conduct of clinical trials and marketing authorizations, and the time required to obtain requisite approvals, may vary widely from country to country and differ from those required for FDA approval.

 

BioLite will be subject to additional regulations in other countries in which we market, sell and import our products, including Canada. BioLite or its distributors must receive all necessary approvals or clearance prior to marketing and/or importing our products in those markets.

 

Other Regulatory Matters

 

Manufacturing, sales, promotion and other activities following product approval are also subject to regulation by numerous regulatory authorities in addition to the FDA, including, in the U.S., the Centers for Medicare & Medicaid Services, other divisions of the Department of Health and Human Services, the Drug Enforcement Administration, the Consumer Product Safety Commission, the Federal Trade Commission, the Occupational Safety &Health Administration, the Environmental Protection Agency and state and local governments. In the U.S., sales, marketing and scientific/educational programs must also comply with state and federal fraud and abuse laws. Pricing and rebate programs must comply with the Medicaid rebate requirements of the U.S. Omnibus Budget Reconciliation Act of 1990 and more recent requirements in the Health Care Reform Law, as amended by the Health Care and Education Affordability Reconciliation Act, or ACA. If products are made available to authorized users of the Federal Supply Schedule of the General Services Administration, additional laws and requirements apply. The handling of any controlled substances must comply with the U.S. Controlled Substances Act and Controlled Substances Import and Export Act. Products must meet applicable child-resistant packaging requirements under the U.S. Poison Prevention Packaging Act. Manufacturing, sales, promotion and other activities are also potentially subject to federal and state consumer protection and unfair competition laws.

 

The distribution of pharmaceutical products is subject to additional requirements and regulations, including extensive recordkeeping, licensing, storage and security requirements intended to prevent the unauthorized sale of pharmaceutical products.

 

The failure to comply with regulatory requirements subjects firms to possible legal or regulatory action. Depending on the circumstances, failure to meet applicable regulatory requirements can result in criminal prosecution, fines, imprisonment or other penalties, injunctions, recall or seizure of products, total or partial suspension of production, denial or withdrawal of product approvals, or refusal to allow a firm to enter into supply contracts, including government contracts. In addition, even if a firm complies with FDA and other requirements, new information regarding the safety or effectiveness of a product could lead the FDA to modify or withdraw product approval. Prohibitions or restrictions on sales or withdrawal of future products marketed by us could materially affect our business in an adverse way.

 

Changes in regulations, statutes or the interpretation of existing regulations could impact our business in the future by requiring, for example: (i) changes to our manufacturing arrangements; (ii) additions or modifications to product labeling; (iii) the recall or discontinuation of our products; or (iv) additional record-keeping requirements. If any such changes were to be imposed, they could adversely affect the operation of our business.

 

Employees

 

As of January 16, 2019, BioLite had twenty-one (21) employees, mostly located in Taiwan.

 

Legal Proceedings

 

BioLite and its subsidiaries are currently not party to any material legal or administrative proceedings and are not aware of any material pending or threatened legal or administrative proceedings in which any of BioLite and its subsidiaries will become involved and that would materially affect BioLite’s business. 

16

 

  

BUSINESS OF BIOKEY

 

BioKey is a specialty pharmaceutical company that provides platform-based control release dosage forms and integrated pharmaceutical services. BioKey’s core expertise is the application of its proprietary oral control release technology to develop specialty generic and branded pharmaceuticals and nutraceuticals. BioKey has four ANDAs approved by the FDA and more than ten product candidates in the pipeline. In addition, BioKey provides integrated pharmaceutical services, including analytical services and product development and manufacturing.

 

Overview

 

Incorporated in California on November 20, 2000, BioKey has chosen to initially focus on developing generic drugs to ride the opportunity of the booming industry. BioKey has received four ANDA approvals from the FDA on the following drugs: BK101 Benazepril Hydrochloride 5, 10, 20 and 40 mg tablets (ANDA 076-820) on February 3, 2006, BK123 Levetiracetam 500mg tablets (ANDA 090-906) on November 5, 2010, and BK119 Cilostazol 50mg (ANDA 077-722) and100mg tablets (ANDA-077-831) on September 24, 2012.

 

BioKey has developed the proprietary control release systems that may delay the release of drugs into human bodies at various controlled paces. BioKey has at least ten more drugs in the company’s development pipeline for instance, BK102 Metaxalone to treat skeletal muscle pain or injury and BK503 Clarithromycin XR for the purpose of treating bacterial infections. In addition to the existing development in the pipeline, BioKey is reviewing potential drug candidates for potential licensing and co-development opportunities. BioKey focuses on the drug candidates that meet one or more of the following criteria:

 

  Niche market potential;

 

  Reliable control of API sources with DMF (Drug Master File) readily in place;

 

  Competitive pricing for the APIs;

 

  High development barrier;

 

  Strategic co-development with distributors; and

 

  Feasible with BioKey’s skill sets and facility capacity

 

Biokey has filed patents to protect its proprietary technologies and information, particularly with respect to its long lasting controlled release platforms and technologies. As of January 16, 2019, BioKey has filed 58 patents in the U.S. and overseas and has four (4) valid patents. The patents that BioKey owns and are seeking to own are centered around the long lasting controlled release dosage compositions, carriers and oral controlled release dosage formulations. BioKey registered its mark as a trademark at USPTO in October 2009.

 

In addition to its long lasting control release technologies, BioKey has a GMP certified facility whereby BioKey and its licensed users manufactures clinical trial materials from Phase 1 to Phase 3 and commercial drug products.

 

BioKey is currently a contract development and manufacturing organization that provides a wide range of services, including API characterization, pre-formulation studies, formulation development, analytical method development, stability studies, IND/NDA/ANDA/510K submissions, and manufacturing clinical trial materials (from Phase 1 through Phase 3) and commercial manufacturing of pharmaceutical products.

 

BioKey provides a variety of regulatory services tailored to the needs of its customers, which include proofreading and regulatory review of submission documents related to formulation development, clinical trials, marketed products, generics, nutraceuticals and OTC products and training presentations. BioKey also on behalf of the clients, submits INDs, NDAs, ANDAs, and DMFs to the FDA in compliance with new electronic submission guidelines of the FDA. BioKey provides regulatory consulting services for the entire lifecycle of client’s drug development project.

 

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BioKey Strategy

 

BioKey believes that the growing needs in the long lasting control release technologies, generic drug development, CDMO services and regulatory support may place the company in a competitive position in the highly developed pharmaceutical industry in the U.S. and overseas, including the Asian market that is developing rapidly. BioKey believes that everyone is entitled to effective and affordable healthcare and the growing needs in precise and controlled release technologies. BioKey’s strategy is to capitalize on these opportunities includes:

 

  Identify and establish alliance with strategic distributors in the U.S. and Asia to develop its drug products in the pipeline;

 

  Co-develop its product pipelines with specialty and generic pharmaceutical companies in the U.S. and Asia to utilize BioKey’s resources and minimize the risk exposure;

 

  Build up a steady clientele base to create sustainable revenues; and

 

  Identify and ally with suitable manufacturing partners in Asia to meet the rapid growing generic drug market in Asia.

 

Products and Technology

 

BioKey’s Long Lasting Control Release Platforms and Technologies

 

BioKey’s core expertise is application of its proprietary oral controlled release technology to develop special generic, branded pharmaceuticals and nutraceuticals. It has developed several controlled release systems that feature various functions with respect to releasing the APIs of different pharmaceuticals and nutraceuticals such as Hydrogel Matrix Delivery System, Membrane-controlled Delivery System, Solid Dispersion Delivery System, Gastric Retention Delivery System, and Ion-exchange Delivery System, etc.

 

The management of BioKey believes that it is important to maintain a pipeline of diverse and selective products under development in order to sustain and grow BioKey’s business. BioKey adopts the following criteria of selecting the potential products in its pipeline:

 

  Great niche market potential;

 

  Reliable control of API sources with DMF(Drug Master File) readily in place;

 

  Competitive pricing for the APIs;

 

  High development barrier;

 

  Strategic co-development with distributors; and

 

  Feasible with BioKey skill sets and facility capacity

 

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As of January 16, 2019, BioKey had the following products in its pipeline including (505)b2 NDA’s and ANDA’s:

 

NDA Products

 

Whereas most generic versions of brand named drugs require only an ANDA for FDA approval, new chemical identities or significant changes to existing drugs, such as new strength, new indication, and new dosage forms, will require an NDA. Given the significant capital requirements for obtaining an NDA, BioKey will in general seek to pursue NDA projects in conjunction with a joint venture partner with significant experiences in developing branded drugs. Although higher capital is required for development, these type of NDA products do offer opportunities for higher profit margins, market exclusivity, as well as patent protection. BioKey names its products starting with “BK”, for example BK501.

 

BK501 : Biokey has developed a new controlled release dosage form of an immediate release antithrombotic drug which has high frequency of side effects. BK501 will vastly improve patient compliance by reducing side effects. Through this joint venture, BioKey will pass portion of financial burden to our strategic alliance and expand its product market to Asia.

 

ANDA Products

 

BioKey has developed the proprietary control release systems that may delay the release of drugs at various controlled paces. BioKey has at least ten more drugs in its development pipeline, such as BK503 Clarithromycin XR for the purpose of treating bacterial infections, BK504 XL for treating depression, and BK509 for lowering cholesterol. In addition to the existing development in the pipeline, BioKey constantly reviews potential drug candidates for potential licensing and co-development opportunities. BioKey focuses on the drug candidates that meet one or more of the following criteria:

 

  Niche market potential;

 

  Reliable control of API sources with DMF(Drug Master File) readily in place;

 

  Competitive pricing for the APIs;

 

  High development barrier;

 

  Strategic co-development with distributors; and

 

  Feasible with BioKey’s skill sets and facility capacity

 

More candidates screened for the ANDA product pipeline include BK602 for obesity, BK603 for diabetes, BK604 for hypertension, and BK605 for Schizophrenia and bipolar disorder, etc.

 

CDMO-related Services

 

Analytical Services

 

BioKey’s analytical laboratory offers HPLC method development and validation, degradation studies, dissolution method development, cleaning validation and raw material testing. Biokey’s experienced chemists and developers adopt analytical assay methods with various columns (reversed phase, ion chromatography, and size exclusion) and UV and reflective index detectors to analyze pharmaceutical compounds that feature with or without chromophores. With respect to degradation studies, BioKey’s senior laboratory researchers conduct stressed sample degradation studies to determine potential degradants and impurity profiles. BioKey’s degradation studies generally involve identification process using diode array analysis of peak purity to develop a stability indicating chromatographic method. In addition, BioKey’s researchers and scientists help the clients to develop and perform dissolution profile studies for immediate release and extended release of finished products (tablets and capsules) in various media and pH buffer solutions such as simulated intestinal fluid (“SIF”), simulated gastric fluid (“SGF”), and acetate. BioKey provides its clients with services of developing and validating sensitive methods for swab samples and rinsing samples and total organic carbon to test and evaluate the cleanness of certain pharmaceutical equipment. BioKey’s laboratory has the capacity to use FT-IR to identify materials, such as APIs. BioKey’s laboratory may conduct basic physical/chemical testing according to various methods such as pH, turbidity, density, solubility profile over pH range, melting point, loss on drying, loss on ignition, viscosity and conductivity testing.

 

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Product Development

 

BioKey provides services for formulation and process development of pharmaceutical products. BioKey supports its clients with FDA regulatory process, including sketches to ANDA, IND, and NDA filings. BioKey endeavors to satisfy the needs of its clients in a time-efficient and cost-saving manner. BioKey’s formulation and process development teams have deep scientific knowledge and extensive experience in this area. BioKey’s highly trained scientists and researchers endeavor to optimize the performance of its clients’ products, formulations and processes, using flexible scientific approaches, such as Design of Experiments (“DOE”) and Quality by Design (QbD).

 

GMP Manufacturing

 

BioKey has a certified GMP manufacturing facility that is qualified to conduct clinical trials from Phase 1 to Phase 3 of drugs in oral solid dosage forms.

 

BioKey’s GMP manufacturing facility can manufacture the following forms of pharmaceutical products and processes for its clients: direct API or blend fill-in capsules, manual and automated encapsulation, wet granulation or tray drying process, tablet compression and coating process, packaging solid dosage forms for ANDA and IND submission.

 

BioKey’s GMP facility consists of the GMP suite, product development area, analytical laboratory, food processing area, caged area and receiving area. The facility was established in December 2008 and received its first drug manufacturing license in June 2009. BioKey’s current drug manufacturing license allows it to manufacture drugs thereon until the expiration of such license on December 2, 2019. BioKey plans to renew its drug manufacturing license in a timely manner before its expiration.

 

Regulatory Support and Consulting Services

 

BioKey provides regulatory support services, including regulatory review of submission documents related to formulation development, clinical trials, marketed products, generics, nutraceuticals and OTC products. BioKey gives training presentations upon the clients’ request. BioKey can prepare labeling with document markup standard approved by Health Level Seven (“HL7”) adopted by the FDA. BioKey can help its clients amend existing labeling or create new Structured Product Labeling (“SPL”). In addition, BioKey can register clients’ manufacturing, analytical, packaging, distribution facility in accordance with 21 CFR 207 through the FDA Electronic Gateway submission platform and maintain the clients’ registration in response to change of information.

 

Research and Development

 

BioKey’s research and development team is based in Fremont, California. It focuses on, among other things, the development of new controlled release platforms and the technologies to integrate such platforms to various drugs. BioKey’s research and development department utilizes its existing technologies to develop additional applications and products. The R&D team takes into consideration the effectiveness of various pharmaceutical products when selecting new products for its research pipeline.

 

Government Regulations

 

Certain of BioKey’s products are new drugs subject to extensive and rigorous regulations by the FDA. FDA regulations govern the following activities that BioKey performs and will perform:

 

  product design and development;

 

  product testing;

 

  product manufacturing;

 

  product safety;

 

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  product labeling;

 

  product storage;

 

  recordkeeping;

 

  premarket clearance or approval;

 

  advertising and promotion; and

 

  product sales and distribution.

 

In addition, BioKey’s GMP facility is subjected to FDA inspection.

 

Employees

 

None of BioKey’s employees are represented by a labor union and BioKey believes its employee relations are good.

 

Facilities

 

BioKey’s headquarters in Fremont, California are leased through February 28, 2021 and occupy approximately 28,186 square feet. The headquarters consist of offices, research and production laboratories, and manufacturing facilities. BioKey has an option to extend the lease for its offices in Fremont a period of five years commencing February 28, 2021, and BioKey may exercise this option for 5 more years. The total rental expenses were $274,978 and $255,240 for the years ended December 31, 2017 and 2016, respectively, and $205,576 for the nine months ended September 30, 2018.

 

Legal Proceedings

 

From time to time BioKey may become involved in legal proceedings and claims, or be threatened with other legal actions and claims, arising in the ordinary course of business relating to its intellectual property, product liability, regulatory compliance and/or marketing and advertising of its products. As of to date, BioKey was not involved or threatened with any legal actions and regulatory proceedings.

 

CERTAIN RISK FACTORS RELATING TO BIOLITE AND BIOKEY

 

This current report on Form 8-k hereby incorporates by reference to the section entitled “Risk Factors” starting on page 22 of the Registration Statement on Form S-4 filed with the Securities and Exchange Commission (the “SEC”) on January 16, 2019.

 

BIOLITE’S MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

This current report on Form 8-k hereby incorporates by reference to the section entitled “BioLite’s Management’s Discussion and Analysis of Financial Condition and Results of Operations” starting on page 128 of the Registration Statement on Form S-4 filed with the Securities and Exchange Commission (the “SEC”) on January 16, 2019.

 

BIOKEY’S MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

This current report on Form 8-k hereby incorporates by reference to the section entitled “BioKey’s Management’s Discussion and Analysis of Financial Condition and Results of Operations” starting on page 147 of the Registration Statement on Form S-4 filed with the Securities and Exchange Commission (the “SEC”) on January 16, 2019.

 

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DIRECTORS AND EXECUTIVE OFFICERS

 

On the Closing Date, the following individuals were elected as the new directors of the Board of the Company:

 

Dr. Tsung-Shann Jiang, Chief Strategy Officer and Director, has been the chairman of BioLite, Inc., a subsidiary of BioLite, Inc., since January 2010. Prior to BioLite, Dr. Jiang served as the president and/or chairman of multiple biotech companies in Taiwan, including PhytoHealth Corporation from 1998 to 2009 and AmCad BioMed Corporation from 2008 to 2009. In addition, Dr. Jiang is a director on various biotech associations, such as the Taiwan Bio Industry Organization (Taiwan) from 2006 to 2008 and the Chinese Herbs and Biotech Development Association in Taiwan from 2003 to 2006. Dr. Jiang was an assistant professor at University of Illinois from 1981 to 1987 and an associate professor at Rutgers, the State University of New Jersey from 1987 to 1990 and served as a professor at a few Taiwanese universities during a period from 1990 to 1993, such as National Taiwan University, National Cheng Kung University and Tunghai University. Dr. Jiang obtained his bachelor degree in Engineering and Chemical Engineering from National Taiwan University in Taiwan in 1976, masters and Ph.D. from Northwestern University in the U.S. in 1981 and Executive Master of Business Administration (“EMBA”) from National Taiwan University in Taiwan in 2007. As a successful entrepreneur, Dr. Jiang has developed and commercialized PG2 Lyo Injection, a new drug to treat cancer related fatigue. From 1998 to 2009, Dr. T. S. Jiang served as President of Phyto Health Corporation where he led a project team to develop PG2 Injectable. This product was extracted, isolated and purified from a type of Traditional Chinese Medicine. PG2 Injection was intended for cancer patients who had trouble recovering from severe fatigue. Dr. Jiang oversaw and managed the R&D department, daily corporate operations and business of Phyto Health Corporation when he was the President. PG2 Lyo Injection received approval on its NDA from Taiwan Food and Drug Administration in 2010 and later was launched into the Taiwan market in 2012. We believe that Dr. Jiang provides leadership and technological guidance on our strategic development and operations.

 

Dr. Chang-Jen Jiang, Director, has been an attending doctor at the department of pediatrics of Eugene Women and Children Clinic since 2009. Previously, Dr. Chang-Jen worked as an attending doctor at the department of pediatrics of Keelung Hospital, the Ministry of Health and Welfare in Taiwan from 1994 to 2009. Before his position at Keelung Hospital, he was a chief doctor at the department of pediatrics, hematology and oncology of Mackay Memorial Hospital in Taiwan for three years until 1994. Dr. Chang-Jen Jiang obtained his doctor of medicine degree (the Taiwanese equivalent degree of MD) from Taipei Medical University in Taiwan in 1982 and started his career in Mackay Memorial Hospital. We believe that the Company will benefit from Dr. Jiang’s knowledge in biology and experiences in medical practice.

 

Dr. Shin-Yu Miao, Director, has served as an associate professor at Ling Tung University Department of Applied Foreign Languages since 2004. She served as a lecturer from 1996 to 2004. Ms. Miao received her M.S. in Adult Education from the University of Manchester in 1995 and Ph.D. in Adult Education from the University of South Australia in 2004. We believe that Ms. Miao’s familiarity with biotech research centers will be a valuable resource for our drug development.

 

Yoshinobu Odaira, Director, is an entrepreneur and has founded a number of Japanese agricultural companies, including Yukiguni Maitake, our licensing partner. In 1983, Mr. Odaira established Yukiguni Maitake, which became a public company in Japan in 1994. In 2015, Bain Capital Private Equity purchased Yukiguni Maitake through a tender offer. In addition to his success with Yukiguni Maitake, Mr. Odaira served as the CEO of Yukiguni Shoji Co., Ltd. since 1988 and the CEO of Odaira Shoji Co., Ltd. from 1989.  In 2015, Mr. Odaira founded two new companies, Shogun Maitake Canada Co., Ltd. in Canada and Odaira Kinoko Research Co., Ltd. in Japan. Yoshinobu Odaira graduated from the Ikazawa Junior High School in 1963. We believe that we will benefit from Mr. Odaira’s successful business experience.

 

Shih-Chen Tzeng, Director, has served as a sales manager at SinoPac Securities Corp. (“SinoPac Securities”), a well-established brokerage firm in Taiwan, since 2000. SinoPac Securities has fifty-eight (58) branch offices in Taiwan and subsidiaries in Hong Kong, Shanghai and London. Shih-Chen Tszeng graduated from Dam Kang University in 1978 with a bachelor degree in Accounting. We believe the Company will benefit from Ms. Tszeng’s knowledge and experience with the securities industries.  

 

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Dr. Hwalin Lee, Director, serves as the chairman of Phoeng Foundation since 2011 and will become the director and chairman of the board of directors of BioKey Surviving Corporation after the closing of the BioKey Merger. From 1986, Dr. Lee has been the chairman of the Chuan Lyu Foundation. From 1973 to 1989, Dr. Lee was the president of Deltan Corporation and prior to that he was senior research chemist at a couple of chemical companies. Dr. Hwalin Lee obtained a B.S. in pharmacy from National Taiwan University in 1957 and a Ph.D. in Pharmaceutical Chemistry from University of California, San Francisco in 1966. Dr. Lee qualifies as a director of the Company because he has extensive work experience in chemical companies and educational background in pharmaceutical chemistry.

 

Dr. Tsung-Shann Jiang was also appointed by the Board of the Company as the Chief Strategy Officer, effective on the Closing Date.

 

Family Relationships

 

There are no family relationships among the executive officers and directors of the Company except that Dr. Tsang Ming Jiang (a current Board member), Dr. Tsung-Shann Jiang and Dr. Chang-Jen Jiang are brothers and Mr. Eugene Jiang (current Chairman and interim CFO) is Dr. Tsung-Shann Jiang’s son.

 

Legal Proceedings

 

Involvement in Certain Legal Proceedings

 

During the past ten years, none of our current directors, executive officers, promoters, control persons, or nominees has been:

 

  the subject of any bankruptcy petition filed by or against any business of which such person was a general partner or executive officer either at the time of the bankruptcy or within two years prior to that time;

 

  convicted in a criminal proceeding or is subject to a pending criminal proceeding (excluding traffic violations and other minor offenses);

 

  subject to any order, judgment, or decree, not subsequently reversed, suspended or vacated, of any court of competent jurisdiction or any Federal or State authority, permanently or temporarily enjoining, barring, suspending or otherwise limiting his involvement in any type of business, securities or banking activities;

 

  found by a court of competent jurisdiction (in a civil action), the Commission or the Commodity Futures Trading Commission to have violated a federal or state securities or commodities law.

 

  the subject of, or a party to, any Federal or State judicial or administrative order, judgment, decree, or finding, not subsequently reversed, suspended or vacated, relating to an alleged violation of (a) any Federal or State securities or commodities law or regulation; (b) any law or regulation respecting financial institutions or insurance companies including, but not limited to, a temporary or permanent injunction, order of disgorgement or restitution, civil money penalty or temporary or permanent cease-and-desist order, or removal or prohibition order; or (c) any law or regulation prohibiting mail or wire fraud or fraud in connection with any business entity; or

 

  the subject of, or a party to, any sanction or order, not subsequently reversed, suspended or vacated, of any self-regulatory organization (as defined in Section 3(a)(26) of the Exchange Act (15 U.S.C. 78c(a)(26))), any registered entity (as defined in Section 1(a)(29) of the Commodity Exchange Act (7 U.S.C. 1(a)(29))), or any equivalent exchange, association, entity or organization that has disciplinary authority over its members or persons associated with a member.

 

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Committees of the Board

 

The Company’s Board is in the process of establishing the audit committee, compensation committee and nominating and corporate governance committee.

 

Our board of directors may establish other committees to facilitate the management of our business.

 

Director Compensation

 

In this regard, it is expected that the Company will not provide compensation to non-employee directors which is in line with ABVC’s current practices.

 

While ABVC does not require directors and officers to own a specific minimum number of shares of ABVC’s Common Stock, it believes that each director and corporate officer should have a substantial personal investment in the Company. Directors and officers may not engage in short sales or put or call transactions with respect to ABVC securities. The Company plans to issue equity awards to all directors (non-employee and employee) for their service in the future. The Company believes that the future arrangements may align the interests of the Board of Directors with the long-term interests of the Company’s shareholders.

 

Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

 

The disclosure set forth above in Item 2.01 of this Current Report is incorporated by reference herein.

 

Item 9.01. Financial Statements and Exhibits.

 

(a) Financial Statements of Business Acquired

 

(d) Exhibits.

 

The exhibits listed in the following Exhibit Index are filed as part of this Current Report on Form 8-K.

 

Exhibit No .   Description
     
3.1   Articles of Merger as filed with the Nevada Secretary of State on February 8, 2019
3.2   Agreement of Merger as filed with the California Secretary of State on February 8, 2019
99.1   Financial Statements of BioLite for the Years Ended December 31, 2017 and 2016
99.2   Financial Statements of BioLite for the Nine Months Ended September 30, 2018
99.3   Financial Statements of BioKey for the Years Ended December 31, 2017 and 2016
99.4   Financial Statements of BioKey for the Nine Months Ended September 30, 2018
99.5   Unaudited Condensed Consolidated Combined Combined Pro Forma Financial Information

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SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  AMERICAN BRIVISION (HOLDING) CORPORATION
     
Date: February 14, 2019 By: /s/ Howard Doong
  Name:  Howard Doong
  Title: Chief Executive Officer

 

 

 

 

Exhibit 3.1

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Exhibit 3.2

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 

 

Exhibit 99.1

 

 

A udit  ● T ax  ● C onsulting  ●  F inancial  A dvisory  

Registered with Public Company Accounting Oversight Board (PCAOB)

 

Report of Independent Registered Public Accounting Firm

 

To the Board of Directors and Shareholders of BioLite Holding, Inc.

 

Opinion on the Financial Statements

 

We have audited the accompanying consolidated balance sheets of BioLite Holding, Inc. and its subsidiaries. ( collectively referred to as “the Company”) as of December 31, 2017 and 2016, the related statements of operations and comprehensive income(loss), stockholders’ equity (deficit), and cash flows for the years then ended, and the related notes (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2017 and 2016, and the results of its operations and its cash flows for the years ended December 31, 2017 and 2016, in conformity with the U.S. generally accepted accounting principles.

 

Basis for Opinion

 

These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

 

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.

 

The accompanying consolidated financial statements have been prepared assuming that BioLite Holding, Inc. and its subsidiaries will continue as a going concern. As described in Note 2 to the consolidated financial statements, the Company has incurred losses from operations, has a working capital deficit, and is in need of additional capital to grow its operations so that it can become profitable. These factors raise substantial doubt about the Company’s ability to continue as a going concern. Management’s plans with regard to these matters are described in Note 2. The accompanying consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

 

/s/ KCCW Accountancy Corp.  
   
We have served as the Company’s auditor since 2017.  
Diamond Bar, California  
April 30, 2018  

 

   
  KCCW Accountancy Corp.
  3333 S Brea Canyon Rd. #206, Diamond Bar, CA 91765, USA
  Tel: +1 909 348 7228 ● Fax: +1 909 895 4155 ● info@kccwcpa.com

 

 

 

 

BIOLITE HOLDING, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

 

    December 31,     December 31,  
    2017     2016  
ASSETS            
Current Assets            
Cash and cash equivalents   $ 256,925     $ 100,464  
Restricted cash     56,579       66,944  
Accounts Receivable - related parties     3,475       1,265  
Receivable from collaboration partners – related parties     -       5,037,500  
Due from related parties     153,953       258  
Inventory, net     199,708       185,951  
Prepaid expenses and other current assets     90,333       43,376  
Total Current Assets     760,973       5,435,758  
Restricted cash - noncurrent     -       185,436  
Property and equipment, net     570,576       563,253  
Long-term investments     4,185,969       3,594,241  
Deferred tax assets     1,017,897       593,021  
Security Deposits     68,876       48,811  
Total Assets   $ 6,604,291     $ 10,420,520  
LIABILITIES AND EQUITY                
Current Liabilities                
Short-term bank loan     927,800       231,481  
Long-term bank loan - current portion     40,203       119,773  
Notes payable     202,429       -  
Accrued expenses     511,212       724,327  
Other payable     16,288       168,551  
Due to related parties     2,390,498       319,910  
Total Current Liabilities     4,088,430       1,564,042  
                 
Noncurrent Liabilities                
Long-term bank loan     55,690       -  
Total Noncurrent Liabilities     55,690       -  
Total Liabilities     4,144,120       1,564,042  
                 
Equity                
Common Stock, $0.0001 par value, 500,000,000 shares authorized, 20,000,000 and 41,207,444 shares issued and outstanding     4,121       2,000  
Additional paid-in capital     10,862,995       11,303,457  
Accumulated deficit     (9,971,033 )     (4,922,762 )
Other comprehensive income     757,327       61,754  
Total Stockholders’ Equity     1,653,410       6,444,449  
Noncontrolling Interest     806,761       2,412,029  
Total Equity     2,460,171       8,856,478  
                 
Total Liabilities and Equity   $ 6,604,291     $ 10,420,520  

 

The accompanying notes are an integral part of these financial statements.

 

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BIOLITE HOLDING, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME

FOR THE YEARS ENDED DECEMBER 31, 2017 AND 2016

 

    2017     2016  
Net revenue            
Merchandise sales   $ 940     $ 2,812  
Merchandise sales-related parties     2,256       3,253  
Collaborative revenue     -       982,083  
Total net revenue     3,196       988,148  
                 
Cost of revenue     2,249       24,318  
                 
Gross profit     947       963,830  
                 
Operating expenses                
Research and development expenses     256,682       823,046  
Selling, general and administrative expenses     1,735,931       1,752,168  
Total operating expenses     1,992,613       2,575,214  
                 
Loss from operations     (1,991,666 )     (1,611,384 )
                 
Other income (expense)                
Interest income     7,207       3,429  
Interest expense     (222,060 )     (7,602 )
Rental income     11,814       11,884  
Impairment loss     -       (1,470,378 )
Investment loss     (34,139 )     -  
Loss on foreign exchange changes     (409,170 )     (85,398 )
Loss on investment in equity securities     (4,443,876 )     (3,560,325 )
Other income (expenses)     51,574       67,328  
Total other income (expenses)     (5,038,650 )     (5,041,062 )
Loss before income taxes     (7,030,316 )     (6,652,446 )
Provision for income taxes expense (benefit)     (360,395 )     (60,660 )
Net loss     (6,669,921 )     (6,591,786 )
Net loss attributable to noncontrolling interests, net of tax     1,621,650       1,669,024  
Net loss attributable to BioLite Holding, Inc.     (5,048,271 )     (4,922,762 )
Foreign currency translation adjustment     695,573       61,754  
Comprehensive Loss   $ (4,352,698 )   $ (4,861,008 )
                 
Net loss per share attributable to common stockholders                
Basic and Diluted   $ (0.16 )   $ (0.25 )
                 
Weighted average number of common shares outstanding:                
Basic and Diluted     30,720,246       20,000,000  

 

The accompanying notes are an integral part of these financial statements.

 

3

 

 

BIOLITE HOLDING, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF EQUITY

FOR THE YEARS ENDED DECEMBER 31, 2017 AND 2016

 

                Additional           Other              
    Common Stocks     Paid-in     Accumulated     Comprehensive     Noncontrolling        
    Shares     Amounts     Capital     Deficit     Income     Interest     Total  
Balance at July 27, 2016 (inception)     -     $ -     $ -     $ -     $ -     $ -     $ -  
Capital Contribution     20,000,000       2,000       -       -       -       -       2,000  
Effects from restructuring     -       -       11,303,457       -       -       4,081,053       15,384,510  
Net income     -       -       -       (4,922,762 )     61,754       (1,669,024 )     (6,530,032 )
Balance at December 31, 2016     20,000,000       2,000       11,303,457       (4,922,762 )     61,754       2,412,029       8,856,478  
Capital Contribution     21,207,444       2,121       7,679,786       -       -       -       7,681,907  
Effects from restructuring     -       -       (8,120,248 )     -       -       16,382       (8,103,866 )
Net income     -       -       -       (5,048,271 )     -       (1,621,650 )     (6,669,921 )
Cumulative translation adjustments     -       -       -       -       695,573       -       695,573  
Balance at December 31, 2017     41,207,444     $ 4,121     $ 10,862,995     $ (9,971,033 )   $ 757,327     $ 806,671     $ 2,460,171  

 

The accompanying notes are an integral part of these financial statements.

 

4

 

 

BIOLITE HOLDING, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CASH FLOWS

FOR THE YEARS ENDED DECEMBER 31, 2017 AND 2016

 

    2017     2016  
Cash flows from operating activities            
Net loss   $ (6,669,921 )   $ (6,591,786 )
Adjustments to reconcile net loss to net cash used in operating activities:                
Depreciation & amortization     43,996       43,777  
Investment loss     34,139       -  
Impairment losses for doubtful account     -       1,470,378  
Loss on investment in equity securities     4,443,876       3,560,325  
Deferred tax     (360,395 )     (60,660 )
Changes in assets and liabilities:                
Decrease (increase) in accounts receivable     (724 )     (533 )
Decrease (increase) in receivable from collaboration revenue     1,054,913       -  
Decrease (increase) in due from related parties     (167,197 )     11,580  
Decrease (increase) in inventory     3,469       19,166  
Decrease (increase) in prepaid expenses and other deposits     (56,973 )     72,408  
Increase (decrease) in accrued expenses and other current liabilities     (338,236 )     151,147  
Increase (decrease) in due to related parties     329,556       295,298  
Net Cash Used In Operating Activities     (1,683,497 )     (1,028,900 )
                 
Cash flows from investing activities                
Restricted cash     213,808       (181,997 )
Net proceeds from sale of investment in equity securities     128,480       -  
Loan to related parties     (32,893 )     -  
Long-term equity investment     (7,803,713 )     (3,070,940 )
Net Cash Used In Investing Activities     (7,494,318 )     (3,252,937 )
                 
Cash flows from financing activities                
Net proceeds from the issuance of common stock     7,681,907       2,000  
Proceeds from loan from related parties     914,427       -  
Capital contribution from related parties under common control     6,579       2,642,823  
Net proceeds from short-term bank loans     657,861       232,728  
Net proceeds from short-term borrowing from third-parties     98,679       93,091  
Repayment of long-term bank loans     (34,156 )     (36,138 )
Net Cash Provided By Financing Activities     9,325,297       2,934,504  
                 
Effect of exchange rate changes on cash and cash equivalents     8,979       22,730  
                 
Net increase (decrease) in cash and cash equivalents     156,461       (1,324,603 )
                 
Cash and cash equivalents                
Beginning     100,464       1,425,067  
Ending   $ 256,925     $ 100,464  
                 
Supplemental disclosure of cash flows                
Cash paid during the year for:                
Income tax   $ -     $ -  
Interest expense   $ 92,238     $ 7,602  
                 
Non-cash financing and investing activities                
Capital contribution from related parties under common control   $ 1,316     $ 6,750,000  

 

The accompanying notes are an integral part of these financial statements

 

5

 

  

BIOLITE HOLDING, INC. AND SUBSIDIARIES

NOTES TO FINANCIAL STATEMENTS

DECEMBER 31, 2017 AND 2016

 

NOTE 1. ORGANIZATION AND BUSINESS

 

BioLite Holding, Inc. (the “BioLite Holding”) was incorporated under the laws of the State of Nevada on July 27, 2016. BioLite BVI, Inc. (the “BioLite BVI”), a wholly owned subsidiary of BioLite Holding, was incorporated in the British Virgin Islands on September 13, 2016. BioLite Holding and BioLite BVI are holding companies and have not carried out substantive business operations of their own.

 

BioLite, Inc., (the “BioLite Taiwan”) was incorporated on February 13, 2006 under the laws of Taiwan. BioLite is in the business of developing and commercialization of new botanical drugs with application in central nervous system, autoimmunity, inflammation, hematology, and oncology. In addition, BioLite Taiwan distributes dietary supplements made from extracts of Chinese herbs and Maitake mushroom.

 

In January 2017, BioLite Holding, BioLite BVI, BioLite Taiwan, and certain shareholders of BioLite Taiwan entered into a share purchase / exchange agreement (the “BioLite Share Purchase / Exchange Agreement”). Pursuant to the BioLite Share Purchase / Exchange Agreement, the shareholder participants to the BioLite Share Purchase / Exchange Agreement have sold their equity in BioLite Taiwan and were using the proceeds from such sales to purchase shares of common stock of BioLite Holding at the same price per share, resulting in their owning the same number of shares of common stock as they owned in the BioLite Taiwan. Upon closing of the Share Purchase/ Exchange Agreement in August 2017, BioLite Holding ultimately owns via BioLite BVI approximately 73% of BioLite Taiwan. The other shareholders who did not enter this Share Purchase/ Exchange Agreement retain their equity ownership in BioLite Taiwan.

 

The fiscal year of BioLite Holding, BioLite BVI, and BioLite Taiwan (collectively referred to as “the Company”) ends on December 31st.

 

NOTE 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

Basis of Presentation and Principles of Consolidation — The accompanying consolidated financial statements, including the accounts of BioLite Holding, BioLite BVI, and BioLite Taiwan, have been prepared in conformity with accounting principles generally accepted in the United States of America. Since BioLite Holding, BioLite BVI, and BioLite Taiwan are the entities under Dr. Tsung-Shann Jiang’s common control prior to the Share Purchase / Exchange Agreement, the transaction is accounted for as a restructuring transaction. All the assets and liabilities of BioLite Taiwan were transferred to BioLite Holding at their respective carrying amounts on the closing date of Share Purchase / Exchange transaction. The Company has recast prior period financial statements to reflect the conveyance of BioLite Taiwan’s common shares as if the restructuring transaction had occurred as of the earliest date of the financial statements. All material intercompany accounts, transactions, and profits have been eliminated in consolidation. The nature of and effects on earnings per share (EPS) of nonrecurring intra-entity transactions involving long-term assets and liabilities is not required to be eliminated and EPS amounts have been recast to include the earnings (or losses) of the transferred net assets.

 

The functional currency of BioLite Taiwan is the New Taiwan dollars, however the accompanying consolidated financial statements have been translated and presented in United States Dollars ($). In the accompanying financial statements and notes, “$”, “US$” and “U.S. dollars” mean United States dollars, and “NT$” and “NT dollars” mean New Taiwan dollars.

 

Going Concern — The accompanying consolidated financial statements have been prepared assuming the Company will continue as a going concern. The Company has incurred losses since its inception resulting in an accumulated deficit of $9,971,033 and $4,922,762 as of December 31, 2017 and 2016, respectively, and incurred net loss attributable to BioLite Holding, Inc. of $5,048,271 and $4,922,762 for the years ended December 31, 2017, and 2016, respectively. The Company also had working capital deficiency of $3,327,457 at December 31, 2017. The ability to continue as a going concern is dependent upon the Company generating profitable operations in the future and/or obtaining the necessary financing to meet its obligations and repay its liabilities arising from normal business operations when they become due. These consolidated financial statements do not include any adjustments to the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should the Company upon signing of that agreement.

 

6

 

 

In order to continue as a going concern, the Company will need, among other things, additional capital resources. Management’s plans to obtain such resources for the Company include (1) obtaining capital from the sale of its equity securities (2) short-term and long-term borrowings from banks and third-parties, and (3) short-term borrowings from stockholders or other related party(ies) when needed. However, management cannot provide any assurance that the Company will be successful in accomplishing any of its plans.

 

The ability of the Company to continue as a going concern is dependent upon its ability to successfully accomplish the plans described in the preceding paragraph and eventually to secure other sources of financing and attain profitable operations.

 

Segment Reporting — The Company follows the provisions of ASC Topic 280, “Segment Reporting”, which establishes standards for reporting information about operating segments, which uses a “management” approach for determining segments. The management approach designates the internal organization that is used by management for making operating decisions and assessing performance as the source of the Company’s reportable segments. ASC Topic 280, “Segment Reporting,” also requires disclosures about products or services, geographic areas, and major customers. The Company’s management reporting structure provided for only one segment in 2017 and 2016. Accordingly, no separate segment information is presented.

 

Use of Estimates — The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the balance sheet date and the reported amounts of revenue and expenses during the reporting period. Actual results could differ from those estimates.

 

Concentration of Credit Risk — The Company’s financial instruments that are exposed to concentrations of credit risk consist primarily of cash and cash equivalents and restricted cash. The Company places its cash and temporary cash investments in high quality credit institutions in Taiwan, but these investments may be in excess of Taiwan Central Deposit Insurance Corporation’s insurance limits. The Company does not enter into financial instruments for hedging, trading, or speculative purposes. Concentration of credit risk with respect to accounts receivables is limited due to the wide variety of customers and markets in which the Company transacts business, as well as their dispersion across many geographical areas. The Company performs ongoing credit evaluations of its customers and generally does not require collateral, but does require advance deposits on certain transactions.

 

Cash and Cash Equivalents — The Company considers all highly liquid investments with maturities of three months or less at the date of purchase to be cash equivalents.

 

Restricted Cash Equivalents — Restricted cash equivalents primarily consist of cash held in a reserve bank account associated with short-term bank loans.

 

Accounts Receivable, Receivable from Collaboration Partners, and Other Receivable — Accounts receivable, receivable from collaboration partners, and other receivables are stated at carrying value less estimates made for doubtful receivables. An allowance for impairment of trade receivable, receivable from collaboration partners, and other receivables is established if the collection of a receivable becomes doubtful. Such receivable becomes doubtful when there is objective evidence that the Company will not be able to collect all amounts due according to the original terms of the receivables. Significant financial difficulties of the debtor, probability that the debtor will enter into bankruptcy or financial reorganization, and default or delinquency in payments are considered indicators that the receivable is impaired. The amount of the allowance is the difference between the asset’s carrying amount and the present value of estimated future cash flows, discounted at the original effective interest rate.

 

7

 

 

Inventory — Inventory consists of raw materials, work-in-process, finished goods, and merchandise. Inventories are stated at the lower of cost or market and valued on a moving weighted average cost basis. Market is determined based on net realizable value. The Company periodically reviews the age and turnover of its inventory to determine whether any inventory has become obsolete or has declined in value, and incurs a charge to operations for known and anticipated inventory obsolescence.

 

Property and Equipment — Property and equipment is carried at cost net of accumulated depreciation. Repairs and maintenance are expensed as incurred. Expenditures that improve the functionality of the related asset or extend the useful life are capitalized. When property and equipment is retired or otherwise disposed of, the related gain or loss is included in operating income. Leasehold improvements are depreciated on the straight-line method over the shorter of the remaining lease term or estimated useful life of the asset. Depreciation is calculated on the straight-line method, including property and equipment under capital leases, generally based on the following useful lives:

 

    Estimated Life
in Years
Buildings and leasehold improvements   5 ~ 50
Machinery and equipment   5 ~ 6
Office equipment   3 ~ 6

 

Impairment of Long-Lived Assets —The Company has adopted Accounting Standards Codification subtopic 360-10, Property, Plant and Equipment (“ASC 360-10”). ASC 360-10 requires that long-lived assets and certain identifiable intangibles held and used by the Company be reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. The Company evaluates its long lived assets for impairment annually or more often if events and circumstances warrant. Events relating to recoverability may include significant unfavorable changes in business conditions, recurring losses, or a forecasted inability to achieve break-even operating results over an extended period. Should impairment in value be indicated, the carrying value of intangible assets will be adjusted, based on estimates of future discounted cash flows resulting from the use and ultimate disposition of the asset. ASC 360-10 also requires assets to be disposed of be reported at the lower of the carrying amount or the fair value less costs to sell. Management has determined that no impairments of long-lived assets currently exist.

 

Fair Value Measurements — FASB ASC 820, “Fair Value Measurements” defines fair value for certain financial and nonfinancial assets and liabilities that are recorded at fair value, establishes a framework for measuring fair value and expands disclosures about fair value measurements. It requires that an entity measure its financial instruments to base fair value on exit price, maximize the use of observable units and minimize the use of unobservable inputs to determine the exit price. It establishes a hierarchy which prioritizes the inputs to valuation techniques used to measure fair value. This hierarchy increases the consistency and comparability of fair value measurements and related disclosures by maximizing the use of observable inputs and minimizing the use of unobservable inputs by requiring that observable inputs be used when available. Observable inputs are inputs that reflect the assumptions market participants would use in pricing the assets or liabilities based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s own assumptions about the assumptions market participants would use in pricing the asset or liability developed based on the best information available in the circumstances. The hierarchy prioritizes the inputs into three broad levels based on the reliability of the inputs as follows:

 

  Level 1 – Inputs are quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date. Valuation of these instruments does not require a high degree of judgment as the valuations are based on quoted prices in active markets that are readily and regularly available.

 

8

 

 

  Level 2 – Inputs other than quoted prices in active markets that are either directly or indirectly observable as of the measurement date, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
     
  Level 3 – Valuations based on inputs that are unobservable and not corroborated by market data. The fair value for such assets and liabilities is generally determined using pricing models, discounted cash flow methodologies, or similar techniques that incorporate the assumptions a market participant would use in pricing the asset or liability.

 

The carrying values of certain assets and liabilities of the Company, such as cash and cash equivalents, restricted cash, accounts receivable, due from related parties, inventory, prepaid expenses and other current assets, accounts payable, accrued liabilities, and due to related parties approximate fair value due to their relatively short maturities. The carrying value of the Company’s short-term bank loan approximates their fair value as the terms of the borrowing are consistent with current market rates and the duration to maturity is short. The carrying value of the Company’s long-term bank loan approximates fair value because the interest rates approximate market rates that the Company could obtain for debt with similar terms and maturities.

 

Long-term Equity Investment — The Company acquires these equity investments to promote business and strategic objectives. The Company accounts for non-marketable equity and other equity investments for which the Company does not have control over the investees as:

 

  Equity method investments when the Company has the ability to exercise significant influence, but not control, over the investee. Its proportionate share of the income or loss is recognized monthly and is recorded in gains (losses) on equity investments.

 

  Non-marketable cost method investments when the equity method does not apply.

 

Significant judgment is required to identify whether an impairment exists in the valuation of the Company’s non-marketable equity investments, and therefore the Company considers this a critical accounting estimate. Its yearly analysis considers both qualitative and quantitative factors that may have a significant impact on the investee’s fair value. Qualitative analysis of its investments involves understanding the financial performance and near-term prospects of the investee, changes in general market conditions in the investee’s industry or geographic area, and the management and governance structure of the investee. Quantitative assessments of the fair value of its investments are developed using the market and income approaches. The market approach includes the use of comparable financial metrics of private and public companies and recent financing rounds. The income approach includes the use of a discounted cash flow model, which requires significant estimates regarding the investees’ revenue, costs, and discount rates. The Company’s assessment of these factors in determining whether an impairment exists could change in the future due to new developments or changes in applied assumptions.

 

Other-Than-Temporary Impairment — The Company’s long-term equity investments are subject to a periodic impairment review. Impairments affect earnings as follows:

 

  Marketable equity securities include the consideration of general market conditions, the duration and extent to which the fair value is below cost, and our ability and intent to hold the investment for a sufficient period of time to allow for recovery of value in the foreseeable future. We also consider specific adverse conditions related to the financial health of, and the business outlook for, the investee, which may include industry and sector performance, changes in technology, operational and financing cash flow factors, and changes in the investee’s credit rating. We record other-than-temporary impairments on marketable equity securities and marketable equity method investments in gains (losses) on equity investments.

 

9

 

 

  Non-marketable equity investments based on our assessment of the severity and duration of the impairment, and qualitative and quantitative analysis of the operating performance of the investee; adverse changes in market conditions and the regulatory or economic environment; changes in operating structure or management of the investee; additional funding requirements; and the investee’s ability to remain in business. A series of operating losses of an investee or other factors may indicate that a decrease in value of the investment has occurred that is other than temporary and that shall be recognized even though the decrease in value is in excess of what would otherwise be recognized by application of the equity method. A loss in value of an investment that is other than a temporary decline shall be recognized. Evidence of a loss in value might include, but would not necessarily be limited to, absence of an ability to recover the carrying amount of the investment or inability of the investee to sustain an earnings capacity that would justify the carrying amount of the investment. The Company records other-than-temporary impairments for non-marketable cost method investments and equity method investments in gains (losses) on equity investments. Other-than-temporary impairments of non-marketable equity investments were $4,277,708 and $3,122,123 for the years ended December 31, 2017 and 2016, respectively.

 

Post-retirement and post-employment benefits — The Company adopted the government mandated defined contribution plan pursuant to the Labor Pension Act (the “Act”) in Taiwan. Such labor regulations require that the rate of contribution made by an employer to the Labor Pension Fund per month shall not be less than 6% of the worker’s monthly salaries. Pursuant to the Act, the Company makes monthly contribution equal to 6% of employees’ salaries to the employees’ pension fund. The Company has no legal obligation for the benefits beyond the contributions made. The total amounts for such employee benefits, which were expensed as incurred, were $26,263 and $32,561 for the years ended December 31, 2017 and 2016, respectively. Other than the above, the Company does not provide any other post-retirement or post-employment benefits.

 

Revenue Recognition — Revenues consist of merchandise sales and collaboration revenue.

 

Merchandise sales Revenue from distribution of dietary supplements are recognized when persuasive evidence of an arrangement exists, delivery has occurred, the sales price is determinable, and collectability of the sales price is reasonably assured.

 

Collaboration Revenue — The Company recognizes collaboration revenue accounting for the various payment flows under its collaborative agreements with BioHopeKing Corporation (the “BHK”) and American BriVision Corporation (the “BriVision”) (See NOTE 3).

 

  (i) Estimated Performance Periods

 

The collaborative agreements contain multiple elements and deliverables, and required evaluation pursuant to ASC 605-25, “Revenue Recognition — Multiple-Element Arrangements.” The Company had multiple deliverables under the collaborative agreements, including deliverables relating to grants of technology licenses, regulatory and clinical development, and marketing activities. Estimation of the performance periods of the Company’s deliverables requires the use of management’s judgment. Significant factors considered in management’s evaluation of the estimated performance periods include, but are not limited to, the Company’s experience in conducting clinical development, regulatory and manufacturing activities. The Company reviews the estimated duration of its performance periods under its collaborative agreements on an annually basis, and makes any appropriate adjustments on a prospective basis. Future changes in estimates of the performance period under its collaborative agreements could impact the timing of future revenue recognition.

 

  (ii) Milestone Payments

 

The Company is eligible to receive milestone payments under the collaborative agreement with collaboration partners based on achievement of specified development, regulatory and commercial events. Management evaluated the nature of the events triggering these contingent payments, and concluded that these events fall into two categories: (a) events which involve the performance of the Company’s obligations under the collaborative agreement with collaboration partners, and (b) events which do not involve the performance of the Company’s obligations under the collaborative agreement with collaboration partners.

 

10

 

 

The former category of milestone payments consists of those triggered by development and regulatory activities in the territories specified in the collaborative agreements. Management concluded that each of these payments constitute substantive milestone payments. This conclusion was based primarily on the facts that (i) each triggering event represents a specific outcome that can be achieved only through successful performance by the Company of one or more of its deliverables, (ii) achievement of each triggering event was subject to inherent risk and uncertainty and would result in additional payments becoming due to the Company, (iii) each of the milestone payments is nonrefundable, (iv) substantial effort is required to complete each milestone, (v) the amount of each milestone payment is reasonable in relation to the value created in achieving the milestone, (vi) a substantial amount of time is expected to pass between the upfront payment and the potential milestone payments, and (vii) the milestone payments relate solely to past performance. Based on the foregoing, the Company recognizes any revenue from these milestone payments in the period in which the underlying triggering event occurs.

 

  (iii) Multiple Element Arrangements

 

The Company analyzes multiple element arrangements based on the guidance in ASC Topic 605-25,  Revenue Recognition—Multiple Element Arrangements,  or ASC 605-25. Pursuant to the guidance in ASC 605-25, the Company evaluates multiple element arrangements to determine (1) the deliverables included in the arrangement and (2) whether the individual deliverables represent separate units of accounting or whether they must be accounted for as a combined unit of accounting. This evaluation involves subjective determinations and requires management to make judgments about the individual deliverables and whether such deliverables are separate from other aspects of the contractual relationship. Deliverables are considered separate units of accounting provided that: (i) the delivered item(s) has value to the customer on a standalone basis and (ii) if the arrangement includes a general right of return relative to the delivered item(s), delivery or performance of the undelivered item(s) is considered probable and substantially within its control. In assessing whether an item under a collaboration has standalone value, the Company considers factors such as the research, manufacturing, and commercialization capabilities of the collaboration partner and the availability of the associated expertise in the general marketplace. The Company also considers whether its collaboration partners can use the other deliverable(s) for their intended purpose without the receipt of the remaining element(s), whether the value of the deliverable is dependent on the undelivered item(s), and whether there are other vendors that can provide the undelivered element(s).

 

The Company recognizes arrangement consideration allocated to each unit of accounting when all of the revenue recognition criteria in ASC 605 are satisfied for that particular unit of accounting. In the event that a deliverable does not represent a separate unit of accounting, the Company recognizes revenue from the combined unit of accounting over the Company’s contractual or estimated performance period for the undelivered elements, which is typically the term of the Company’s research and development obligations. If there is no discernible pattern of performance or objectively measurable performance measures do not exist, then the Company recognizes revenue under the arrangement on a straight-line basis over the period the Company is expected to complete its performance obligations. Conversely, if the pattern of performance in which the service is provided to the customer can be determined and objectively measurable performance measures exist, then the Company recognizes revenue under the arrangement using the proportional performance method. Revenue recognized is limited to the lesser of the cumulative amount of payments received or the cumulative amount of revenue earned, as determined using the straight-line method or proportional performance method, as applicable, as of the period ending date.

 

11

 

 

At the inception of an arrangement that includes milestone payments, the Company evaluates whether each milestone is substantive and at risk to both parties on the basis of the contingent nature of the milestone. This evaluation includes an assessment of whether: (1) the consideration is commensurate with either the Company’s performance to achieve the milestone or the enhancement of the value of the delivered item(s) as a result of a specific outcome resulting from its performance to achieve the milestone, (2) the consideration relates solely to past performance and (3) the consideration is reasonable relative to all of the deliverables and payment terms within the arrangement. The Company evaluates factors such as the scientific, clinical, regulatory, commercial, and other risks that must be overcome to achieve the particular milestone and the level of effort and investment required to achieve the particular milestone in making this assessment. There is considerable judgment involved in determining whether a milestone satisfies all of the criteria required to conclude that a milestone is substantive. Milestones that are not considered substantive are recognized as earned if there are no remaining performance obligations or over the remaining period of performance, assuming all other revenue recognition criteria are met.

 

  (iv) Royalties and Profit Sharing Payments

 

Under the collaborative agreement with the collaboration partners, the Company is entitled to receive royalties on sales of products, which is at certain percentage of the net sales. The Company recognizes revenue from these events based on the revenue recognition criteria set forth in ASC 605-10-25-1, “Revenue Recognition”. Based on those criteria, the Company considers these payments to be contingent revenues, and recognizes them as revenue in the period in which the applicable contingency is resolved.

 

Income Taxes — Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carry forwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date.

 

Valuation of Deferred Tax Assets — A valuation allowance is recorded to reduce our deferred tax assets to the amount that is more likely than not to be realized. In assessing the need for the valuation allowance, management considers, among other things, projections of future taxable income and ongoing prudent and feasible tax planning strategies. If the Company determines that sufficient negative evidence exists, then it will consider recording a valuation allowance against a portion or all of the deferred tax assets in that jurisdiction. If, after recording a valuation allowance, the Company’s projections of future taxable income and other positive evidence considered in evaluating the need for a valuation allowance prove, with the benefit of hindsight, to be inaccurate, it could prove to be more difficult to support the realization of our deferred tax assets. As a result, an additional valuation allowance could be required, which would have an adverse impact on its effective income tax rate and results. Conversely, if, after recording a valuation allowance, the Company determines that sufficient positive evidence exists in the jurisdiction in which the valuation allowance was recorded, it may reverse a portion or all of the valuation allowance in that jurisdiction. In such situations, the adjustment made to the deferred tax asset would have a favorable impact on its effective income tax rate and results in the period such determination was made. See Note 13 for information related to income taxes, including the recorded balances of its valuation allowance related to deferred tax assets.

 

The Company applied the provisions of ASC 740-10-50, “Accounting For Uncertainty In Income Taxes”, which provides clarification related to the process associated with accounting for uncertain tax positions recognized in our financial statements. Audit periods remain open for review until the statute of limitations has passed. The completion of review or the expiration of the statute of limitations for a given audit period could result in an adjustment to the Company’s liability for income taxes. Any such adjustment could be material to the Company’s results of operations for any given quarterly or annual period based, in part, upon the results of operations for the given period. As of December 31, 2017 and 2016, management considered that the Company had no uncertain tax positions, and will continue to evaluate for uncertain positions in the future.

 

12

 

 

Share-Based Compensation — The Company recognizes share-based compensation expense for share-based compensation awards granted to its employees and officers. Compensation expense for share-based compensation awards granted is based on the grant date fair value estimate for each award as determined by its board of directors. The Company recognizes these compensation costs on a straight-line basis over the requisite service period of the award, which is generally one to two years. As share-based compensation expense recognized is based on awards ultimately expected to vest, such expense is reduced for estimated forfeitures.

 

The Company estimates the fair value of stock-based compensation awards at the date of grant using the Black-Scholes option pricing model, which requires the input of highly subjective assumptions, including the fair value of the underlying common stock, expected term of the option, expected volatility of the price of its common stock, risk-free interest rates, and the expected dividend yield of our common stock. The assumptions used in the Company’s option-pricing model represent management’s best estimates. These estimates involve inherent uncertainties and the application of management’s judgment. If factors change and different assumptions are used, the Company’s stock-based compensation expense could be materially different in the future.

 

These assumptions and estimates are as follows:

 

  Fair value of the underlying common stock. Because the Company’s stocks are not publicly traded, the assumptions used in the valuation model are based on future expectations combined with management judgment. In the absence of a public trading market, the board of directors, with input from management, exercised significant judgment and considered numerous objective and subjective factors to determine the fair value of our common stock as of the date of each option grant, including the following factors:

 

a) contemporaneous valuations performed by unrelated third-party specialists;

b) the lack of marketability of its common stock;

c) the Company’s actual operating and financial performance, and current business conditions and projections;

d) the Company’s hiring of key personnel and the experience of our management;

e) the Company’s history and the timing of the introduction of new products and services;

 

In valuing the common stock, the fair value of the underlying common stock was determined by using the value indications under a combination of valuation approaches, including a discounted cash flow analysis under the income approach, market approaches, and the latest round of equity financing at grant date

 

  Expected term. The expected term represents the period that the stock-based compensation awards are expected to be outstanding. Since the Company did not have sufficient historical information to develop reasonable expectations about future exercise behavior, it used the simplified method to compute expected term, which represents the average of the time-to-vesting and the contractual life.

 

  Expected volatility. As the Company does not have a trading history for its common stock, the expected stock price volatility for its common stock was estimated by taking the mean standard deviation of stock prices for selected companies in biotechnogy industry listed in Taiwan’s stock markets.

 

  Risk-free interest rate. The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the time of grant for zero coupon U.S. Treasury notes with maturities approximately equal to the expected term of the options.

 

  Expected dividend yield. The Company has never declared or paid any cash dividends and do not presently plan to declare or pay cash dividends in the foreseeable future. Consequently, we used an expected dividend yield of zero.

 

The valuations are highly complex and subjective. Following the completion of this offering, common stock valuations will no longer be necessary as the Company will rely on market prices to determine the fair value of its common stock.

 

13

 

 

Foreign-currency Transactions — For the Company’s subsidiaries in Taiwan, the foreign-currency transactions are recorded in New Taiwan dollars (“NTD”) at the rates of exchange in effect when the transactions occur. Gains or losses resulting from the application of different foreign exchange rates when cash in foreign currency is converted into New Taiwan dollars, or when foreign-currency receivables or payables are settled, are credited or charged to income in the year of conversion or settlement. On the balance sheet dates, the balances of foreign-currency assets and liabilities are restated at the prevailing exchange rates and the resulting differences are charged to current income except for those foreign currencies denominated investments in shares of stock where such differences are accounted for as translation adjustments under Equity.

 

Translation Adjustment — The accounts of BioLite Taiwan was maintained, and its financial statements were expressed, in New Taiwan Dollar (“NT$”). Such financial statements were translated into U.S. Dollars (“$” or “USD”) in accordance ASC 830, “Foreign Currency Matters”, with the NT$ as the functional currency. According to the Statement, all assets and liabilities are translated at the current exchange rate, stockholder’s deficit are translated at the historical rates and income statement items are translated at an average exchange rate for the period. The resulting translation adjustments are reported under other comprehensive income as a component of stockholders’ deficit.

 

Research and Development — The Company accounts for R&D costs in accordance with Accounting Standards Codification (“ASC”) 730, Research and Development (“ASC 730”). Research and development expenses are charged to expense as incurred unless there is an alternative future use in other research and development projects or otherwise. Research and development expenses are comprised of costs incurred in performing research and development activities, including personnel-related costs, share-based compensation, and facilities-related overhead, outside contracted services including clinical trial costs, manufacturing and process development costs for both clinical and preclinical materials, research costs, upfront and development milestone payments under collaborative agreements and other consulting services. Non-refundable advance payment for goods and services that will be used in future research and development activities are expensed when the activity has been performed or when the goods have been received rather than when the payment is made. In instances where the Company enters into agreements with third parties to provide research and development services, costs are expensed as services are performed. Amounts due under such arrangements may be either fixed fee or fee for service, and may include upfront payments, monthly payments, and payments upon the completion of milestones or receipt of deliverables. Research and development expense was $256,682 and $823,046 for the years ended December 31, 2017 and 2016, respectively.

 

Promotional and Advertising Costs Promotional and advertising costs are classified as selling and general and administrative expenses, and are expensed as incurred. Promotional and advertising expenses consist primarily of the costs of designing, producing, and distributing materials promoting the Company and its products, including its corporate website. Promotional and advertising costs were $842 and $38,792 for the years ended December 31, 2017 and 2016, respectively.

 

Statement of Cash Flows Cash flows from the Company’s operations are based upon the local currencies. As a result, amounts related to assets and liabilities reported on the statement of cash flows will not necessarily agree with changes in the corresponding balances on the balance sheet.

 

Comprehensive Income — Comprehensive income includes accumulated foreign currency translation gains and losses. The Company has reported the components of comprehensive income in its statements of operations and comprehensive income (loss).

 

Recently Issued Accounting Pronouncements — In February 2016, the FASB issued ASU No. 2016-02, “Leases.” The core principle of the ASU is that a lessee should recognize the assets and liabilities that arise from its leases other than those that meet the definition of a short-term lease. The ASU requires extensive qualitative and quantitative disclosures, including with respect to significant judgments made by management. Subsequently, the FASB issued ASU No. 2017-13, in September 2017 and ASU No. 2018-01, in January 2018, which amends and clarifies ASU 2016-02. The ASU will be effective for the Company beginning January 1, 2019, including interim periods in the fiscal year 2019. Early adoption is permitted. The Company is in the process of determining the method of adoption and assessing the impact of this ASU on its consolidated results of operations, cash flows, financial position and disclosures.

 

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In March 2016, the FASB issued ASU 2016-08, Revenue from Contracts with Customers (Topic 606): Principal versus Agent Considerations (Reporting Revenue Gross versus Net). In April 2016, the FASB issued ASU 2016-10, Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing. In May 2016, the FASB issued ASU 2016-12, Revenue from Contracts with Customers (Topic 606): Narrow-Scope Improvements and Practical Expedients and ASU 2016-11, Revenue Recognition (Topic 605) and Derivatives and Hedging (Topic 815): Rescission of SEC Guidance Because of Accounting Standards Updates 2014-09 and 2014-16 Pursuant to Staff Announcements at the March 3, 2016 EITF Meeting. In December 2016, the FASB issued ASU 2016-20, Technical Corrections and Improvements to Topic 606, Revenue from Contracts with Customers. In September 2017, the FASB issued ASU 2017-13, Revenue Recognition (Topic 605), Revenue from Contracts with Customers (Topic 606), Leases (Topic 840), and Leases (Topic 842). These amendments provide additional clarification and implementation guidance on the previously issued ASU 2014-09, Revenue from Contracts with Customers (Topic 606). The amendments in ASU 2016-08 clarify how an entity should identify the specified good or service for the principal versus agent evaluation and how it should apply the control principle to certain types of arrangements. ASU 2016-10 clarifies the following two aspects of ASU 2014-09: identifying performance obligations and licensing implementation guidance. ASU 2016-11 rescinds several SEC Staff Announcements that are codified in Topic 605, including, among other items, guidance relating to accounting for consideration given by a vendor to a customer, as well as accounting for shipping and handling fees and freight services. ASU 2016-12 provides clarification to Topic 606 on how to assess collectability, present sales tax, treat noncash consideration, and account for completed and modified contracts at the time of transition. ASU 2016-12 clarifies that an entity retrospectively applying the guidance in Topic 606 is not required to disclose the effect of the accounting change in the period of adoption. Additionally, ASU 2016-20 clarifies certain narrow aspects within Topic 606 including its scope, contract cost accounting, and disclosures. The new guidance requires enhanced disclosures, including revenue recognition policies to identify performance obligations to customers and significant judgments in measurement and recognition. The effective date and transition requirements for these amendments are the same as the effective date and transition requirements of ASU 2014-09, which is effective for fiscal years, and for interim periods within those years, beginning after December 15, 2017. The Company is currently evaluating the overall impact that ASU 2014-09 and its related amendments will have on the Company’s financial statements.

 

On December 22, 2017, the SEC issued Staff Accounting Bulletin (“SAB 118”), which provides guidance on accounting for tax effects of the Tax Act. SAB 118 provides a measurement period that should not extend beyond one year from the Tax Act enactment date for companies to complete the accounting under ASC 740. In accordance with SAB 118, a company must reflect the income tax effects of those aspects of the Act for which the accounting under ASC 740 is complete. In March 2018, the FASB issued ASU 2018-05, Amendments to SEC Paragraphs Pursuant to SEC Staff Accounting Bulletin No. 118 (SEC Update), Income Taxes (Topic 740). ASU 2018-05 provides guidance regarding the recording of tax impacts where uncertainty exists, in the period of adoption of the 2017 U.S. Tax Cuts and Jobs Act (the “2017 Tax Act”).To the extent that a company’s accounting for certain income tax effects of the Tax Act is incomplete but it is able to determine a reasonable estimate, it must record a provisional estimate to be included in the financial statements. If a company cannot determine a provisional estimate to be included in the financial statements, it should continue to apply ASC 740 on the basis of the provision of the tax laws that were in effect immediately before the enactment of the Tax Act. While the Company is able to make reasonable estimates of the impact of the reduction in corporate rate and the deemed repatriation transition tax, the final impact of the Tax Act may differ from these estimates, due to, among other things, changes in our interpretations and assumptions, additional guidance that may be issued by the I.R.S., and actions we may take. The Company is continuing to gather additional information to determine the final impact.

 

In February 2018, the FASB issued Accounting Standards Update No. 2018-02 (ASU 2018-02), Income Statement - Reporting Comprehensive Income (Topic 220). The guidance in ASU 2018-02 allows an entity to elect to reclassify the stranded tax effects related to the Tax Cuts and Jobs Act (the Tax Act) of 2017 from accumulated other comprehensive income into retained earnings. ASU 2018-02 is effective for fiscal years beginning after December 15, 2018, with early adoption permitted. The Company is currently evaluating the effect this standard will have on its Consolidated Financial Statements.

 

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NOTE 3. COLLABORATIVE AGREEMENTS

 

(a) Collaborative agreements with BHK

 

(i)     On February 24, 2015, BioLite Taiwan and BioHopeKing Corporation (the “BHK”) entered into a co-development agreement, (the “BHK Co-Development Agreement”), pursuant to which it is collaborative with BHK to develop and commercialize BLI-1401-2 (Botanical Drug) Triple Negative Breast Cancer (TNBC) Combination Therapy (BLI-1401-2 Products) in Asian countries excluding Japan for all related intellectual property rights, and has developed it for medicinal use in collaboration with outside researchers. The development costs shall be shared 50/50 between BHK and the Company. The BHK Co-Development Agreement will remain in effect for fifteen years from the date of first commercial sale of the Product in in Asia excluding Japan.

 

On July 27, 2016, BioLite Taiwan and BHK agreed to amend the payment terms of the milestone payment in an aggregate amount of $10 million based on the following schedule:

 

  Upon the signing of the BHK Co-Development Agreement: $1 million, or 10% of total payment

 

  Upon the first Investigational New Drug (IND) submission and BioLite Taiwan will deliver all data to BHK according to FDA Reviewing requirement: $1 million, or 10% of total payment

 

  At the completion of first phase II clinical trial: $1 million, or 10% of total payment

 

  At the initiation of phase III of clinical trial research: $3 million, or 30% of total payment

 

  Upon the New Drug Application (NDA) submission: $4 million, or 40% of total payment

 

In December 2015, BHK has paid a non-refundable upfront cash payment of $1 million, or 10% of $10,000,000, upon the signing of BHK Co-Development Agreement. The Company concluded that the deliverables are considered separate units of accounting as the delivered items have value to the customer on a standalone basis and recognized this cash receipt as collaboration revenue when all research, technical, and development data was delivered to BHK in 2015. The receipt is for the compensation of past research efforts and contributions made by BioLite Taiwan before this collaborative agreement was signed and it does not relate to any future commitments made by BioLite Taiwan and BHK in this collaborative agreement. In August 2016, the Company has received the second milestone payment of NT$31,649,000, approximately equivalent to $1 million, and recognized collaboration revenue for the year ended December 31, 2016. As of the date of this report, the Company has not completed the first phase II clinical trial.

 

In addition to the milestone payments, BioLite Taiwan is entitled to receive royalty on 12% of BHK’s net sales related to BLI-1401-2 Products. As of December 31, 2017 and 2016, the Company has not earned the royalty under the BHK Co-Development Agreement.

 

(ii)   On December 9, 2015, BioLite Taiwan entered into another two collaborative agreements (the “BHK Collaborative Agreements”), pursuant to which it is collaborative with BHK to co-develop and commercialize BLI-1005 for “Targeting Major Depressive Disorder” (BLI-1005 Products) and BLI-1006 for “Targeting Inflammatory Bowel Disease” (BLI-1006 Products) in Asia excluding Japan for all related intellectual property rights, and has developed it for medicinal use in collaboration with outside researchers. The development costs shall be shared 50/50 between BHK and the Company. The BHK Co-Development Agreement will remain in effect for fifteen years from the date of first commercial sale of the Product in in Asia excluding Japan.

 

In 2015, the Company recognized the cash receipt in a total of NT$50 million, approximately equivalent to $1.6 million, as collaboration revenue when all research, technical, and development data was delivered to BHK. The Company concluded that the deliverables are considered separate units of accounting as the delivered items have value to the customer on a standalone basis and recognized this payment as collaboration revenue when all research, technical, data and development data was delivered to BHK. The cash receipt is for the compensation of past research efforts and contributions made by BioLite Taiwan before this BHK Collaborative Agreements was signed and it does not relate to any future commitments made by BioLite Taiwan and BHK in this BHK Collaborative Agreements.

 

In addition to the total of NT$50 million, approximately equivalent to $1.60 million, BioLite Taiwan is entitled to receive 50% of the future net licensing income or net sales profit. As of December 31, 2017 and 2016, the Company has not earned the royalty under the BHK Collaborative Agreements.

 

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(b) Collaborative Agreement with BriVision

 

On December 29, 2015, BioLite Taiwan and BriVision entered into a collaborative agreement (the “BriVision Collaborative Agreement”), pursuant to which it is collaborative with BriVision to develop and commercialize five products, including BLI-1005 CNS-Major Depressive Disorder, BLI-1008 CNS-Attention Deficit Hyperactivity Disorder, BLI-1401-1 Anti-Tumor Combination Therapy – Solid Tumor with Anti-PD-1, BLI-1401-2 Anti-Tumor Combination Therapy – Triple Negative Breast Cancer, and BLI-1501 Hematology-Chronic Lymphocytic Leukemia ( collectively “Five Products”) in the United States of America and Canada for all related intellectual property rights, and has developed it for medicinal use in collaboration with outside researchers. On January 12, 2017, BioLite Taiwan entered into an Addendum (the “Addendum”) to the BriVision Collaborative Agreement, pursuant to which BioLite Taiwan and BriVision agreed to include one more product, namely, “Maitake Combination Therapy” as one of the Products defined in the BioLite Collaborative Agreement (the “Sixth Product”) and defined the Territory of the Sixth Product to be worldwide and restate the Territory of the Five Products to be the U.S.A and Canada. The BriVision Collaborative Agreement will remain in effect for fifteen years from the date of first commercial sale of the Five Products in the North America Region. Either party may terminate upon thirty days’ prior written notice for breach or insolvency.

 

Under the BioLite Collaborative Agreement, BriVision should pay a total of $100,000,000 in cash or stock of BriVision with equivalent value, according to the following schedule:

 

  Upfront payment shall be made upon the signing of this BioLite Collaborative Agreement: 3.5% of total payment. After receiving upfront payment from BriVision, BioLite Taiwan has to deliver all data to BriVision in one week

 

  Upon the first IND submission, BriVision shall pay, but no later than December 15, 2016: 6.5% of total payment. After receiving second payment from BriVision, BioLite has to deliver IND package to BriVision in one week.

 

  At the completion of first phase II clinical trial, BriVision shall pay, but no later than September 15, 2017: 15% of total payment. After receiving third payment from BriVision, BioLite has to deliver phase II clinical study report to BriVision in three months.

 

  Upon the phase III IND submission, BriVision shall pay, but no later than December 15, 2018: 20% of total payment. After receiving forth payment from BriVision, BioLite has to deliver IND package to BriVision in one week.

 

  At the completion of phase III, BriVision shall pay, but no later than September 15, 2019:25% of total payment. After receiving fifth payment from BriVision, BioLite has to deliver phase III clinical study report to BriVision in three months.

 

  Upon the NDA submission, BriVision shall pay, but no later than December 15, 2020, BriVision shall pay: 30% of total payment. After receiving sixth payment from BriVision, BioLite has to deliver NDA package to BriVision in one week.

 

An upfront payment of $3,500,000 (the “Milestone Payment”), or 3.5% of $100,000,000, was due in December 2015 under the BriVision Collaborative Agreement. On May 6, 2016, BioLite Taiwan and BriVision amended the payment terms under the BriVision Collaborative Agreement, whereby BriVision has agreed to pay the upfront payment to the Company $2,600,000 in cash and $900,000 in newly issued shares of common stock of BriVision’s holding company, American BriVision (Holding) Corporation (“ABVC”), a Nevada company, at the price of $1.60 per share, for an aggregate number of 562,500 shares. The cash payment and shares issuance were completed in June 2016. The Company concluded that the deliverables are considered separate units of accounting as the delivered items have value to the customer on a standalone basis. The receipt is for the compensation of past research efforts and contributions made by BioLite Taiwan before this collaborative agreement was signed and it does not relate to any future commitments made by BioLite Taiwan and BriVision in this collaborative agreement.

 

17

 

 

In March 2016, BioLite Taiwan has submitted the first IND and delivered the IND package to BriVision. In February 2017, BriVision agreed to pay the 6.5% of total payment, $6,500,000 to BioLite Taiwan with $650,000 in cash and $5,850,000 in the form of newly issued shares of common stock of ABVC, at the price of $2.0 per share based on the quoted price (for the shares) provided by OTC Markets Group Inc., for an aggregate number of 2,925,000 shares. Since the common stock shares of ABVC are lightly traded in the over-the-counter market, the Company considered to utilize other fair value inputs, such as the bid-ask spread, in determining the fair value of the shares as of December 31, 2017 and 2016. As of December 31, 2017, the first phase II clinical trial research has not completed yet.

 

Since both BioLite Taiwan, BriVision, and ABVC are related parties and under common control by Dr. Tsung-Shann Jiang, the Company has recorded the full amount of $6,500,000 and $3,500,000 in connection with the BriVision Collaborative Agreement as additional paid-in capital during the years ended December 31, 2016 and 2015, respectively.

 

Under the Collaborative Agreement, BioLite Taiwan is also entitled to 5% of net sales of the Products. There have not been any commercial sales since the Collaborative Agreement became effective.

 

The Company evaluated the Collaboration Agreement in accordance with the provisions of ASC, Topic 605-25,  Revenue Recognition—Multiple Element Arrangements . The Company’s arrangement with BHK contains the following deliverables: (i) the license right to develop and use proprietary technology and confidential information for BLI-1401-2 Products, and its related intellectual property rights (the “BLI-1401-2 Deliverable”), (ii) ) the license right to develop and use proprietary technology and confidential information for BLI-1005 Products, and its related intellectual property rights (the “BLI-1005 Deliverable”), and (iii) ) the license right to develop and use proprietary technology and confidential information for BLI-1006 Products, and its related intellectual property rights (the “BLI-1006 Deliverable”). The Company’s arrangement with BriVision contains the license right to develop and use proprietary technology and confidential information for the Five Products and the Sixth Product, and their related intellectual property rights (the “Five Products and the Sixth Product Deliverable).

 

The Company has concluded that each of herein deliverables identified at the inception of the arrangement has standalone value from each of the elements based on their nature. Factors considered in this determination included, among other things, the capabilities of the collaboration partner, whether any other vendor sells the item separately, whether the value of the deliverable is dependent on the other elements in the arrangement, whether there are other vendors that can provide the items and if the customer could use the item for its intended purpose without the other deliverables in the arrangement. Additionally, the Collaboration Agreement does not include a general right of return. Accordingly, each of herein deliverables included in the BHK and BriVision arrangements qualifies as a separate unit of accounting. Therefore, the Company has identified seven units of accounting in connection with its obligations under the collaboration arrangement with BHK and BriVision as follows: (i) BLI-1005 Products, (ii) BLI-1006 Products, (iii) BLI-1008 Products, (iv) BLI-1401-1 Products, (v) BLI-1401-2 Products, (vi) BLI-1401-2 Products, and (vii) Maitake Product (the Sixth Product).

 

18

 

 

NOTE 4. INVENTORY

 

Inventory consists of the following:

 

    December 31,
2017
    December 31,
2016
 
Merchandise   $ 4,951     $ 7,784  
Finished goods     104,454       95,556  
Work-in-process     20,885       19,106  
Raw materials     69,418       63,505  
Inventory, net   $ 199,708     $ 185,951  

 

NOTE 5. LONG-TERM INVESTMENTS

 

(1) The ownership percentages of each investee are listed as follows:

 

    Ownership percentage      
    As of December 31,      
Name of related party   2017     2016     Accounting treatment
Braingenesis Biotechnology Co., Ltd.     0.23 %     0.23 %   Cost Method
Genepharm Biotech Corporation     0.98 %     0.98 %   Cost Method
BioHopeKing Corporation     9.60 %     9.87 %   Cost Method
BioFirst Corporation     21.51 %     22.11 %   Equity Method
American BriVision (Holding) Corp.     2.32 %     0.96 %   Equity Method
Rgene Corporation     13.04 %     -     Equity Method

 

(2) The extent the investee relies on the company for its business are summarized as follows:

 

Name of related party   The extent the investee relies on the company for its business
Braingenesis Biotechnology Co., Ltd.   No specific business relationship
Genepharm Biotech Corporation   No specific business relationship
BioHopeKing Corporation   Collaborating with the Company to develop and commercialize drugs
American BriVision (Holding) Corp.   Collaborating with the Company to develop and commercialize drugs
Rgene Corporation   Loan to the investee
BioFirst Corporation   Loan from the investee and provide research and development support service

 

(3) Long-term investment mainly consists of the following:

 

    As of December 31,  
    2017     2016  
Non-marketable Cost Method Investments            
Braingenesis Biotechnology Co., Ltd.   $ 7,442     $ 6,808  
Genepharm Biotech Corporation     22,720       20,785  
BioHopeKing Corporation (See NOTE 3 & 12)     2,261,524       2,068,875  
Sub total     2,291,686       2,096,468  
Equity Method Investments                
BioFirst Corporation (NOTE 12)     1,894,283       1,497,773  
American BriVision (Holding) Corp. (See NOTE 3 & 12)     -       -  
Rgene Corporation (NOTE 12)     -       -  
Total   $ 4,185,969     $ 3,594,241  

 

(a) BioFirst Corporation (the “BioFirst):

 

The Company holds an equity interest in BioFirst Corporation, (the “BioFirst”), accounting for its equity interest using the equity method to accounts for its equity investment as prescribed in ASC 323, Investments—Equity Method and Joint Ventures (“ASC 323”). Equity method adjustments include the Company’s proportionate share of investee’s income or loss and other adjustments required by the equity method. As of December 31, 2017 and 2016, the Company owns 21.51% and 22.11% common stock shares of BioFirst, respectively.

 

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Summarized financial information for the Company’s equity method investee, BioFirst, is as follows:

 

Balance Sheet

 

      As of December 31,  
      2017     2016  
  Current Assets   $ 6,903,042     $ 5,160,082  
  Noncurrent Assets     2,730,701       1,993,818  
  Current Liabilities     318,074       460,290  
  Shareholders’ Equity     9,315,669       6,693,610  

 

Statement of operation

 

      Year Ended December 31,  
      2017     2016  
  Net sales   $ 3,030,034     $ 39,015  
  Gross Profit     3,003,885       11,476  
  Net income (loss)     1,665,472       (1,646,859 )
  Share of loss from investments accounted for using the equity method     358,243       (364,121 )

 

(b) American BriVision (Holding) Corp. (the “ABVC”):

 

Both ABVC and the Company are under common control by Dr. Tsung-Shann Jiang, the CEO and chairman of the Company. Since Dr. Tsung-Shann Jiang is able to exercise significant influence, but not control, over the American BriVision (Holding) Corp., (the “ABVC”), the Company determined to use the equity method to accounts for its equity investment as prescribed in ASC 323, Investments—Equity Method and Joint Ventures (“ASC 323”). Equity method adjustments include the Company’s proportionate share of investee’s income or loss and other adjustments required by the equity method. As of December 31, 2017 and 2016, the Company owns 2.32% and 0.96% common stock shares of ABVC, respectively.

 

Summarized financial information for the Company’s equity method investee, ABVC, is as follows:

 

Balance Sheet

 

      As of December 31,  
      2017     2016  
  Current Assets   $ 2,643,332     $ 18,645  
  Current Liabilities     4,400,247       6,538,100  
  Shareholders’ Equity(Deficit)     (1,756,915 )     (6,519,455 )

 

Statement of operation

 

      Year Ended December 31,  
      2017     2016  
  Net sales   $ -     $ -  
  Gross Profit     -       (32 )
  Net loss     (4,242,860 )     (7,716,723 )
  Share of loss from investments accounted for using the equity method     (98,434 )     (74,081 )

 

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(c) Rgene Corporation (the “Rgene”):

 

Both Rgene and the Company are under common control by Dr. Tsung-Shann Jiang, the CEO and chairman of the Company. Since Dr. Tsung-Shann Jiang is able to exercise significant influence, but not control, over the American BriVision (Holding) Corp., (the “ABVC”), the Company determined to use the equity method to accounts for its equity investment as prescribed in ASC 323, Investments—Equity Method and Joint Ventures (“ASC 323”). Equity method adjustments include the Company’s proportionate share of investee’s income or loss and other adjustments required by the equity method. As of December 31, 2017 and 2016, the Company owns 13.04% and 0% common stock shares of Rgene, respectively.

 

Summarized financial information for the Company’s equity method investee, Rgene, is as follows:

 

Balance Sheet

 

      As of December 31,  
      2017     2016  
  Current Assets   $ 48,557     $ 33,073  
  Noncurrent Assets     81       74  
  Current Liabilities     3,118,897       146,697  
  Shareholders’ Equity(Deficit)     (3,070,259 )     (113,550 )

 

Statement of operation

 

      Year Ended December 31,  
      2017     2016  
  Net sales   $ -     $ -  
  Gross Profit     -       -  
  Net loss     (3,266,696 )     (806,020 )
  Share of loss from investments accounted for using the equity method     (425,977 )     -  

 

(4) Gains (Losses) on Equity Investments

 

The components of gains (losses) on equity investments for each period were as follows:

 

    December 31,  
    2017     2016  
For the Years Ended            
Share of equity method investee losses   $ (166,168 )   $ (438,202 )
Impairments     (4,277,708 )     (3,122,123 )
Total gains (losses) on equity investments   $ (4,443,876 )   $ (3,560,325 )

 

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NOTE 6. PROPERTY AND EQUIPMENT

 

Property and equipment as of December 31, 2017 and 2016 are summarized as follows:

 

    December 31,
2017
    December 31,
2016
 
Land   $ 374,953     $ 343,013  
Buildings and leasehold improvements     299,623       274,099  
Machinery and equipment     90,130       82,451  
Office equipment     21,968       20,096  
      786,674       719,659  
Less: accumulated depreciation     (216,098 )     (156,406 )
Property and equipment, net   $ 570,576     $ 563,253  

 

Depreciation expenses were $43,996 and $43,777 for the years ended December 31, 2017 and 2016, respectively.

 

NOTE 7. BANK LOANS

 

(1) Short-term bank loan consists of the following:

 

    December 31,     December 31,  
    2017     2016  
Cathay United Bank   $ 253,036     $ 231,481  
CTBC Bank     674,764       -  
Total   $ 927,800     $ 231,481  

 

Cathay United Bank

On June 28, 2016, BioLite Taiwan and Cathay United Bank entered into a one-year bank loan agreement (the “Cathay United Loan Agreement”) in an amount of NT$7,500,000, equivalent to $231,481. The term started June 28, 2016 with maturity date at June 28, 2017. The loan balance bears interest at a floating rate of prime rate plus 1.15%. The prime rate is based on term deposit saving interest rate of Cathay United Bank. On September 6, 2017, BioLite Taiwan extended the Cathay United Loan Agreement for one more year with the principal amount of NT$7,500,000, equivalent to $253,036. The new maturity date is September 6, 2018. As of December 31, 2017 and 2016, the effective interest rates per annum were 2.22%. The loan is collateralized by the building and improvement of BioLite Taiwan, and is also personal guaranteed by the Company’s chairman.

 

Interest expenses were $4,096 and $2,211 for the years ended December 31, 2017 and 2016, respectively.

 

CTBC Bank

On June 12, 2017 and July 19, 2017, BioLite Taiwan and CTBC Bank entered into short-term saving secured bank loan agreements (the “CTBC Loan Agreements”) in an amount of NT$10,000,000, equivalent to $337,382, and NT$10,000,000, equivalent to $337,382, respectively. Both two loans with the same maturity date at January 19, 2018. The loan balances bear interest at a fixed rate of 1.63% per annum. The loan is secured by the money deposited in a savings account with the CTBC Bank.

 

Interest expenses were $4,849 and $0 for the years ended December 31, 2017 and 2016, respectively.

 

(2) Long-term bank loan consists of the following:

 

    December 31,     December 31,  
    2017     2016  
Cathay United Bank   $ 95,893     $ 119,773  
Less: current portion of long-term bank loan     (40,203 )     (119,773 )
Total   $ 55,690     $ -  

 

22

 

 

On April 30, 2010, BioLite Taiwan entered a seven-year bank loan of NT$8,900,000, equivalent to $300,270, with Cathay United Bank. The term started April 30, 2010 with maturity date at April 30, 2017. On April 30, 2017, BioLite Taiwan extended the original loan agreement for additional three years with the new maturity date at April 30, 2020. The loan balance bears interest at a floating rate of prime rate plus variable rates from 0.77% to 1.17%. The prime rate is based on term deposit saving interest rate of Cathay United Bank. As of December 31, 2017 and 2016, the actual interest rates per annum were 2.24%. The loan is collateralized by the building and improvement of BioLite Taiwan, and is also personal guaranteed by the Company’s chairman.

 

Interest expenses were $2,305 and $3,277 for the years ended December 31, 2017 and 2016, respectively.

 

NOTE 8. NOTES PAYABLE

 

On November 27, 2017, BioLite Taiwan and Cheng-Chi International Co., Ltd., a Taiwanese company, entered into a promissory note for borrowing an aggregate amount of NT$6,000,000, equivalent to $202,429, for the period from November 27, 2017 to January 11, 2018. The principal of promissory note bears interest at 12% per annum. This promissory note is secured by 700,000 common stock shares of ABVC and is also personal guaranteed by the Company’s chairman. As of the date of this report, the principal and accrued interest totaling NT$6,090,000, equivalent to $205,465, has been paid in full.

 

NOTE 9. ACCRUED EXPENSES

 

Accrued expenses mainly consist of the following:

 

    December 31,
2017
    December 31,
2016
 
Accrued salaries and bonus   $ 45,862     $ 114,026  
Accrued employee benefits and pension expenses     9,390       14,582  
Accrued sales tax     -       327  
Accrued professional service fees     8,300       26,342  
Accrued research and development expenses     2,656       87,577  
Accrued cost of collaboration revenue payable     400,600       436,681  
Others     44,404       44,792  
    $ 511,212     $ 724,327  

 

NOTE 10. OTHER PAYABLE

 

Other payable mainly consists of the following:

 

    December 31,
2017
    December 31,
2016
 
Other payable   $ 4,532     $ 65,877  
Taiwan income tax withholding payable     11,756       10,081  
Borrowing from third party     -       92,593  
    $ 16,288     $ 168,551  

 

On December 5, 2016, the Company entered a loan agreement bearing interest at a fixed rate at 13.6224% per annum with a third party to advance NT$3,000,000, equivalent to $92,593, for working capital purpose. The term of the loan started from December 5, 2016 with maturity date on February 4, 2017. Interest expense was $0 and $1,057 for the years ended December 31, 2017 and 2016, respectively.

 

23

 

 

NOTE 11. SHARE-BASED COMPENSATION

 

On November 15, 2013, the Board of Directors of BioLite Taiwan approved the adoption of the 2013 Stock Option and Incentive Plan, (the “2013 Plan”), providing for the issuance under 2013 Plan of options and rights to purchase up to two million seventy thousand (2,070,000) shares of common stock. Awards of incentive options may be granted under the 2013 Plan until December 31, 2017. As of December 31, 2017 and 2016, there were 487,000 shares available for issuance under the 2013 Plan, which provides for the grant of share-based awards to employees and officers.

 

Plan Administration ─ The 2013 Plan may be administered by the full Board of Directors of BioLite Taiwan. The Board of BioLite Taiwan has full power to select, from among the individuals eligible for awards, the individuals to whom awards will be granted, to make any combination of awards to participants, and to determine the specific terms and conditions of each award, subject to the provisions of the 2013 Plan.

 

Eligibility Persons eligible to participate in 2013 Plan will be those full time employees and officers of the Company as selected from time to time by the Board of BioLite Taiwan in its discretion.

 

Limits ─ Under 2013 Plans, stock options granted to any individual employee cannot exceed 25% of the Plan, neither to exceed 3% of the total common stock shares issued by BioLite Taiwan.

 

Stock Options ─ The option exercise price of each option under both plans was determined by the Company’s status at the date of grant: (i) before public offering date: the option exercise price would be NT$12.5, equivalent to $0.39, per share and NT$15.0, equivalent to $0.46, per share for the 2013 Plan, respectively, (ii) after public offering date: the exercise price would be decided by the Board of BioLite Taiwan, and not less than the book value per share on the latest financial report before the date of grant, (iii) after been listed on the secondary market, the option exercise price would be the market price, but not less than the par value of the common stock. The exercise price of an option may not be reduced after the date of the option grant, other than to appropriately reflect changes in our capital structure. The term of the option was determined by the Board of Directors of BioLite Taiwan, under the 2013 Plan, employees could exercise 50%, 75%, and 100% of the options at 6 months, 12 months and 24 months after the date of grant. In general, unless otherwise permitted by the Board of BioLite Taiwan, no option granted under 2013 Plan are transferable by the optionee other than by will or by the laws of descent and distribution, and options may be exercised during the optionee’s lifetime only by the optionee, or by the optionee’s legal representative or guardian in the case of the optionee’s incapacity.

 

Under 2013 Plan, upon exercise of options, the option exercise price must be paid in full either in cash, by certified or bank check, or other instrument acceptable to the Board BioLite Taiwan. Subject to applicable law, the exercise price may also be delivered to BioLite Taiwan by a broker pursuant to irrevocable instructions to the broker from the optionee. To qualify as incentive options, options must meet additional tax requirements.

 

Tax Withholding ─ Participants in the 2013 Plan are responsible for the payment of any taxes that BioLite Taiwan is required by law to withhold upon the exercise of options or vesting of other awards. Subject to approval by the Board, participants may elect to have the minimum tax withholding obligations satisfied by authorizing BioLite Taiwan to withhold shares of common stock to be issued pursuant to the exercise or vesting.

 

Amendments and Termination ─ The Board of Directors of BioLite Taiwan may at any time amend or discontinue the 2013 Plan, and the Board of BioLite Taiwan may at any time amend or cancel any outstanding award for the purpose of satisfying changes in the law or for any other lawful purpose. However, no such action may adversely affect any rights under any outstanding award without the holder’s consent. Any amendments that materially change the terms of 2013 Plan will be subject to approval by the administrative authorities.

 

24

 

 

The following table summarizes the stock option activity under the 2013 Plan, and related information:

 

Options Outstanding
    Number of           Weighted-        
    Shares     Weighted-     Average        
    Underlying     Average     Remaining     Aggregate  
    Outstanding     Exercise     Contractual     Intrinsic  
    Options     Price     Life (Years)     Value  
Outstanding – January 1, 2016     487,000     $ 0.4600       2.13     $      -  
Granted     -       -       -       -  
Exercised     -       -       -       -  
Forfeited or cancelled     -       -       -       -  
Outstanding – December 31, 2016     487,000     $ 0.4600       2.13     $ -  
Granted     -       -       -       -  
Exercised     -       -       -       -  
Forfeited or cancelled     -       -       -       -  
Outstanding – December 31, 2017     487,000     $ 0.4600       2.13     $ -  
                                 
Exercisable – December 31, 2017     487,000     $ 0.4600       2.13     $ -  
                                 
Vested and expected to vest – December 31, 2017     487,000     $ 0.4600       2.13     $ -  
                                 
Exercisable – December 31, 2016     487,000     $ 0.4600       2.13     $ -  
                                 
Vested and expected to vest – December 31, 2016     487,000     $ 0.4600       2.13     $ -  

 

Compensation expense related to share-based transactions is measured and recognized in general and administrative expenses in the financial statements based on the fair value of the awards granted. The share-based compensation expense, net of forfeitures, is recognized on a straight-line basis over the requisite service periods of the awards, which is generally a half year to two years. As of December 31, 2017 and 2016, all stock options under 2013 Plan were fully vested. Accordingly, the Company recognized stock based compensation expense of $0 and $0 for the years ended December 31, 2017 and 2016, respectively.

 

25

 

 

NOTE 12. RELATED-PARTY TRANSACTION

 

Related parties:

 

(1) Lion Arts Promotion Inc. (hereinafter, “LION”) was incorporated on March 17, 1997 under the laws of Taiwan. LION is in the business of art related promotion and is a controlling shareholder of BioLite Taiwan.

 

(2) BioFirst Corporation (hereinafter, “BioFirst”) was incorporated on November 7, 2006 under the laws of Taiwan. BioFirst is in the business of researching, developing, manufacturing, and marketing of innovative patented medical products. As of December 31, 2017 and 2016, the Company owns 21.51% and 22.11% common stock shares of BioFirst (See NOTE 5), respectively.

 

(3) BioHopeKing Corporation (hereinafter, “BHK”) was incorporated on September 1, 2014 under the laws of Taiwan. BHK is in the business of research and development of various cancer drugs and the innovation of medical devices. In 2015, BHK has entered one co-development and two collaborative agreements with the Company (See NOTE 3). In December 2015, the Company acquired 900,000 shares of common stock of BHK for NT$54,000,000 (equivalent approximately $1,822,000) in cash. In August 2016, the Company acquired additional 407,000 shares of common stock of BHK for NT$28,490,000, (equivalent approximately $961,200) in cash. As of December 31, 2017 and 2016, the Company owned 9.60% and 9.87% common stock of BHK, respectively (See NOTE 5).

 

(4) American BriVision Corporation (hereinafter, “BriVision”) was incorporated on July 21, 2015 in the State of Delaware, engaging in biotechnology and focuses on the development of new drugs and innovative medical devices to fulfill unmet medical needs. In 2015, BriVision entered a collaborative agreement with the Company (See NOTE 3). On May 6, 2016, the Company and BriVision entered into an addendum to the collaborative agreement, whereby BriVision has agreed to pay the upfront payment to the Company $2,600,000 in cash and $900,000 in newly issued shares of common stock of BriVision’s holding company, American BriVision (Holding) Corporation (“ABVC”), a Nevada company, at the price of $1.60 per share, for an aggregate number of 562,500 shares. In August 2016, the Company made additional equity investment of $2,350,000 in cash to acquire 1,468,750 shares of common stock of ABVC. In February 2017, the Company received $650,000 in cash and $5,850,000 in the form of newly issued 2,925,000 shares of common stock of ABVC, at the price of $2.0 per share for the first milestone payment. As of December 31, 2017 and 2016, the Company owned 2.32% and 0.96% common stock of ABVC, respectively (SEE NOTE 5).

 

(5) Regene Corporation (hereinafter, “Rgene”) was incorporated on June 24, 2010 under the laws of Taiwan. Rgene is in the business of research and development and innovation of various drugs. On March 23, 2017, the Company acquired 600,000 shares of common stock of Rgene for NT$15,000,000 (equivalent approximately $506,000) in cash. As of December 31, 2017 and 2016, the Company owned 13.04% and 0% common stock of Rgene, respectively (See NOTE 5).

 

(6) AsianGene Corporation (hereinafter, “AsianGene”) was incorporated on December 16, 2013 under the laws of Taiwan. Rgene is in the business of real estate development. AsianGene is one of the shareholders of the Company.

 

(7) Mr. Tsung-Shann Jiang is the chairman and CEO of the Company and the President and a member of board of directors of BioFirst. Mr. Jiang is also the controlling beneficiary shareholder of ABVC, BriVision, and Rgene. Ms. Shu-Ling Jiang, Mr. Tsung-Shann Jiang’s wife, is the chairman of LION and BioFirst, and a member of board of directors of the Company. Mr. Eugene Jiang is Mr. and Ms. Jiang’s son. Mr. Eugene Jiang is a member of board of directors of the Company, and is also the chairman, and majority shareholder of ABVC. Mr. Tsung-Shann Jiang, Ms. Shu-Ling Jiang, and Mr. Eugene Jiang hereinafter are collectively called “JIANGS”.

 

26

 

 

Related party transactions:

 

For the year ended and at December 31, 2017, the related party transactions are summarized as follows:

 

                Merchandise Sales /                 Receivable from              
    Amounts     Amounts     Service     Accounts     Collaboration     collaboration     Loan to     Rent  
    due from     due to     Revenue     receivable     Revenue (a)     Partners (a)     (Loan from)     Expenses (b)  
LION   $ -     $ 23,171     $ 2,256     $ 1,350     $ -     $ -     $ -     $ 37,592  
BioFirst     -       1,118,361       7,894       2,125       -       -       (937,922 )     -  
BHK     -       -       -       -       -       -       -       -  
ABVC & BriVision     115,168       -       -       -       -       -       -       -  
Rgene     3,316       -       -       -       -       -       33,738       -  
AsianGene     1,731       -       -       -       -       -       -       -  
JIANGS     -       311,044       -       -       -       -       -       -  
Total   $ 120,215     $ 1,452,576     $ 10,150     $ 3,475     $ -     $ -     $ (904,184 )   $ 37,592  

 

For the year ended and at December 31, 2016, the related party transactions are summarized as follows:

 

                Merchandise Sales /                 Receivable from              
    Amounts     Amounts     Service     Accounts     Collaboration     collaboration     Loan to     Rent  
    due from     due to     Revenue     receivable     Revenue (a)     Partners (a)     (Loan from)     Expenses (b)  
LION   $ -     $ -     $ 3,121     $ 617     $ -     $ -     $           -     $ 35,463  
BioFirst     258       -       9,536       648       -       -       -       -  
BHK     -       -       -       -       982,083       -       -       -  
ABVC & BriVision     -       -       -       -       -       5,037,500       -       -  
Rgene     -       -       132       -       -       -       -       -  
AsianGene     -       -       -       -       -       -       -       -  
JIANGS     -       319,910       -       -       -       -       -       -  
Total   $ 258     $ 319,910     $ 12,789     $ 1,265     $ 982,083     $ 5,037,500     $ -     $ 35,463  

 

(a) See NOTE 3.

 

(b) The Company leases its office from LION, which automatically renews the lease agreement annually. The monthly base rent is approximately $3,000. Rent expense under this lease agreement amounted to $37,592 and $35,463 for the years ended December 31, 2017 and 2016, respectively

 

NOTE 13. INCOME TAX

 

U.S.A

 

BioLite Holding, Inc. files income tax returns in the U.S. federal jurisdiction, and state and local jurisdictions.

 

On December 22, 2017   H.R. 1 ,  originally known as the Tax Cuts and Jobs Act, (the “Tax Act”) was enacted. Among the significant changes to the U.S. Internal Revenue Code, the Tax Act lowers the U.S. federal corporate income tax rate (“Federal Tax Rate”) from 35% to 21% effective January 1, 2018 The 21% Federal Tax Rate will apply to earnings reported for the full 2018 fiscal year. In addition, the Company must re-measure its net deferred tax assets and liabilities using the Federal Tax Rate that will apply when these amounts are expected to reverse. As of December 31, 2017, the Company can determine a reasonable estimate for certain effects of tax reform and is recording that estimate as a provisional amount. The provisional remeasurement of the deferred tax assets and allowance valuation of deferred tax assets at December 31, 2017 resulted in a net effect of $0 discrete tax expenses (benefit) which lowered the effective tax rate by 14% for the years ended December 31, 2017. The provisional remeasurement amount is anticipated to change as data becomes available allowing more accurate scheduling of the deferred tax assets and liabilities primarily related to net operating loss carryover.

 

27

 

 

British Virgin Islands

 

BioLite BVI, Inc. was incorporated in British Virgin Islands, which does not tax income.

 

Taiwan

 

BioLite Inc. was incorporated in Taiwan. According to the amendments to the “Income Tax Act” enacted by the office of the President of the R.O.C. on February 7, 2018, an increase in the statutory income tax rate from 17% to 20% and decrease in the undistributed earning tax from 10% to 5% are effective from January 1, 2018. This increase in the statutory income tax rate does not affect the amounts of the current taxes recognized as of December 31, 2017 and for the year then ended. No income tax liabilities existed as of December 31, 2017 due to the Company’s continuing operating losses. As of December 31, 2017, we had deferred tax assets related to tax loss and credit carryforwards totaling $1,017,897 that begin to expire in 2025.

 

Provision for income tax consists of the following:

 

    2017     2016  
Current provision            
U.S.A   $ -     $ -  
Taiwan     -       -  
Sub total   $ -     $ -  
Deferred provision                
U.S.A   $ -     $ -  
Taiwan     (360,395 )     (60,660 )
Total provision for income tax(benefit)   $ (360,395 )   $ (60,660 )

 

The components of deferred tax assets consisted of the following

 

    December 31,
2017
    December 31,
2016
 
Deferred tax assets:            
U.S.A            
Tax loss and credit carryforwards   $ 155,612     $ 105,000  
Less: Valuation allowance     (155,612 )     (105,000 )
Subtotal     -       -  
Taiwan                
Loss on disposal of assets   $ 694,810     $ 540,279  
Tax loss and credit carryforwards     1,017,897       593,021  
Less: Valuation allowance     (694,810 )     (540,279 )
Subtotal     1,017,897       593,021  
Total deferred tax assets   $ 1,017,897     $ 593,021  

 

28

 

 

The difference between the combined effective income tax rate reflected in the provision for income tax on income (loss) before taxes and the amounts determined by applying the applicable the U.S. statutory income tax rate and Taiwan unified income tax rate for the years ended December 31, 2017 and 2016 are analyzed below:

 

    For the Years Ended
December 31,
 
    2017     2016  
             
U.S. statutory income tax rate     35 %     35 %
Taiwan unified income tax rate     17 %     17 %
Provisional remeasurement of deferred taxes (U.S. & Taiwan)     (11 )%     - %
Changes in valuation allowance     (46 )%     (53 )%
Effective combined income tax rate     (5 )%     (1 )%

 

NOTE 14. COMMITMENTS

 

Operating lease commitment:

 

The Company’s operating leases include lease contracts of office spaces, laboratory space, and employees’ dormitory. Future minimum lease payments under the operating leases are summarized as follows:

 

Fiscal Year   Amount  
2018   $ 75,511  
2019     51,359  
Thereafter     -  
Total   $ 126,870  

 

In-Licensing collaborative agreement commitment:

 

(1) On January 1, 2011, the Company entered a collaborative agreement with Medical and Pharmaceutical Industry Technology and Development Center (“PITDC”), a Taiwanese Company. Pursuant to the collaborative agreement, PITDC granted the Company the sole licensing right for drug and therapeutic use of depressive disorders related patent and technology expired in November 2026. The total consideration for obtaining such grant was NT$17,000,000(equivalent approximately $573,500), of which NT$3,400,000(equivalent approximately $114,710) is due within 30 days upon signing the agreement and the remaining balance of NT$13,600,000 (equivalent approximately $458,000) is due pursuant to a milestone payment schedule. In addition, the Company is required to pay PITDC 10% of sublicensing revenues net of related research and development cost and royalties at a range from 1% to 3% of sales of drugs.

 

The Company paid the upfront payment of NT$3,400,000 (equivalent approximately $114,710) in 2011, the first milestone payment of NT$2,550,000 (equivalent approximately $86,000) in 2012, and the third milestone payment of NT$2,125,000 (equivalent approximately $71,700) in 2013. The Company recorded these amounts as research and development expenses when incurred.

 

29

 

 

Pursuant to the in-licensing collaboration agreement with PITDC, the Company is required to pay PITDC 10% of sublicensing revenues to PITDC. During the years ended December 31, 2017 and 2016, the Company has paid $0 and $46,773 (equivalent to NT$1,507,320) to PITDC accounting for 10% of sublicensing revenues net of related research and development cost and royalties. As of December 31, 2017 and 2016, the Company accrued milestone payments payable of $282,728 and $258,744 to PITDC.

 

(2) On February 10, 2011, the Company entered a collaborative agreement with Industrial Technology Research Institute (“ITRI”), a Taiwanese Company. Pursuant to the collaborative agreement, ITRI granted the Company the sole licensing right for drug and therapeutic use of colon inflammation related patent and technology expired in February 2031. The total consideration for obtaining such grant was NT$20,000,000 (equivalent approximately to $674,700), of which NT$2,000,000 (equivalent approximately $67,400) is due sixth days upon signing the agreement and the remaining balance of NT$18,000,000(equivalent approximately $607,300) is due pursuant to a milestone payment schedule. In addition, the Company is required to pay ITRI 10% of sublicensing revenues net of related research and development cost and royalties at a range from 3% to 5% of sales of drugs.

 

The Company paid the upfront payment of NT$2,000,000(equivalent approximately$67,400) in 2011 and the first milestone payment of NT$2,000,000 (equivalent approximately $67,400) in 2016. The Company recorded these amounts as research and development expenses when incurred.

 

Pursuant to the in-licensing collaboration agreement with ITRI, the Company is required to pay ITRI 10% of sublicensing revenues to ITRI. During the years ended December 31, 2017 and 2016, the Company has paid $0 and $62,060 (equivalent to NT$2,000,000) to ITRI accounting for 10% of sublicensing revenues net of related research and development cost and royalties.

 

(3) On February 10, 2011, the Company entered a collaborative agreement with Industrial Technology Research Institute (“ITRI”), a Taiwanese Company. Pursuant to the collaborative agreement, ITRI granted the Company the sole licensing right for drug and therapeutic use of rheumatoid arthritis related patent and technology expired in February 2031. The total consideration for obtaining such grant was NT$35,000,000(equivalent approximately $1,180,000), of which NT$3,500,000(equivalent approximately $118,000) is due sixth days upon signing the agreement and the remaining balance of NT$31,500,000(equivalent approximately $1,062,000) is due pursuant to a milestone payment schedule. In addition, the Company is required to pay ITRI 10% of sublicensing revenues net of related research and development cost and royalties at a range from 3% to 5% of sales of drugs.

 

The Company paid the upfront payment of NT$3,500,000(equivalent approximately $118,000) in 2011. The Company recorded these amounts as research and development expenses when incurred. As of December 31, 2017 and 2016, the Company has not sublicensed the licensing right for drug and therapeutic use of rheumatoid arthritis related patent and technology to any companies.

 

(4) On December 27, 2016, the Company entered a collaborative agreement with Yukiguni Maitake Co., Ltd (“YUKIGUNI”), a Japan company. Pursuant to the collaborative agreement, YUKIGUNI granted the Company the right for selling Maitake dry powder and Maitake extract manufactured by YUKIGUNI, and the right for using Maitake related patent and technology expired in December 2036 or fifteen years after the date when the new product developed by the Company is first sold, whichever is earlier. The total consideration for obtaining such grant would be $305,000. As of December 31, 2016, the Company is not obligated to pay the licensing payment pursuant as YUKIGUNI has not completed any of milestones specified in the agreement.

 

NOTE 15. SUBSEQUENT EVENT

 

The Company has evaluated subsequent events through the date which the financial statements were available to be issued. All subsequent events requiring recognition as of December 31, 2017 have been incorporated into these financial statements and there are no subsequent events that require disclosure in accordance with FASB ASC Topic 855, “Subsequent Events.”

 

******

 

30

Exhibit 99.2

 

 

 

 

 

 

 

 

 

 

 

 

BIOLITE HOLDING, INC.

 

Financial Statements for the Nine Months Ended

 

September 30, 2018 and 2017

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

BIOLITE HOLDING, INC. AND SUBSIDAIRIES

CONSOLIDATED BALANCE SHEETS

 

    September 30,     December 31,  
    2018     2017  
ASSETS   (UNAUDITED)        
Current Assets            
  Cash and cash equivalents   $ 183,353     $ 256,925  
  Restricted cash     -       56,579  
  Accounts receivable     2,050       -  
  Accounts receivable - related parties     656       3,475  
  Due from related parties     129,567       153,953  
  Inventory, net     183,065       199,708  
  Prepaid expenses and other current assets     185,252       90,333  
        Total Current Assets     683,943       760,973  
                 
Property and equipment, net     522,067       570,576  
Long-term investments     3,316,878       4,185,969  
Deferred tax assets     1,227,334       1,017,897  
Security deposits     47,280       68,876  
Total Assets   $ 5,797,502     $ 6,604,291  
LIABILITIES AND EQUITY                
Current Liabilities                
  Short-term bank loan     656,000       927,800  
  Long-term bank loan - current portion     39,737       40,203  
  Notes payable     497,248       202,429  
  Accrued expenses     639,719       511,212  
  Other payable     145,338       16,288  
  Due to related parties     2,757,064       2,390,498  
        Total Current Liabilities     4,735,106       4,088,430  
Noncurrent Liabilities                
  Long-term bank loan     25,092       55,690  
        Total Noncurrent Liabilities     25,092       55,690  
               Total Liabilities     4,760,198       4,144,120  
                 
Equity                
Common Stock, $0.0001 par value, 500,000,000 shares authorized, 41,207,444 shares issued and outstanding at September 30, 2018 and December 31, 2017     4,121       4,121  
Additional paid-in capital     10,862,995       10,862,995  
Accumulated deficit     (10,980,204 )     (9,971,033 )
Other comprehensive income     676,227       757,327  
     Total Stockholders' Equity     563,139       1,653,410  
Noncontrolling Interest     474,165       806,761  
              Total Equity     1,037,304       2,460,171  
             Total Liabilities and Equity   $ 5,797,502     $ 6,604,291  

 

The accompanying notes are an integral part of these financial statements.

 

2

 

 

BIOLITE HOLDING, INC. AND SUBSIDAIRIES

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME(LOSS)

FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2018 AND 2017

(UNAUDITED)

 

    Three Months Ended 
September 30,
   

Nine Months Ended 
September 30,

 
    2018     2017     2018     2017  
Net revenue                                
    Merchandise sales   $ 747     $ 314     $ 3,976     $ 937  
    Merchandise sales-related parties     -       4       -       1,624  
          Total net revenue     747       318       3,976       2,561  
                                 
Cost of revenue     537       5       2,856       1,589  
                                 
Gross profit     210       313       1,120       972  
                                 
Operating expenses                                
Research and development expenses     10,213       52,293       224,316       232,613  
    Selling, general and administrative expenses     210,560       401,429       693,057       1,531,815  
          Total operating expenses     220,773       453,722       917,373       1,764,428  
                                 
Loss from operations     (220,563 )     (453,409 )     (916,253 )     (1,763,456 )
                                 
Other income (expense)                                
Interest income     1,507       1,048       3,761       6,098  
   Interest expense     (79,475 )     (76,315 )     (231,300 )     (171,389 )
   Rental income     2,909       2,963       8,997       8,835  
   Investment loss     (201,590 )     (104 )     (287,513 )     (34,043 )
   Gain (loss) on foreign currency changes     (67 )     1,702       7,403       (406,778 )
   Gain (loss) on investment in equity securities     (39,166 )     64,774       (164,649 )     (4,379,650 )
   Other income (expenses)     (1,357 )     370       (4,305 )     48,500  
          Total other income (expenses)     (317,239 )     (5,562 )     (667,606 )     (4,928,427 )
Loss before income taxes     (537,802 )     (458,971 )     (1,583,859 )     (6,691,883 )
Provision for income taxes expense (benefit)     (69,075 )     (64,900 )     (242,092 )     (224,762 )
Net loss     (468,727 )     (394,071 )     (1,341,767 )     (6,467,121 )
Net loss attributable to noncontrolling interests, net of tax     116,491       93,562       332,596       1,574,038  
Net loss attributable to BioLite Holding, Inc.     (352,236 )     (300,509 )     (1,009,171 )     (4,893,083 )
Foreign currency translation adjustment     (12,040 )     (1,166,855 )     (81,100 )     (597,136 )
Comprehensive Loss   $ (364,276 )   $ (1,467,364 )   $ (1,090,271 )   $ (5,490,219 )
                                 
Net loss per share attributable to common stockholders                                
Basic and Diluted   $ (0.01 )   $ (0.01 )   $ (0.02 )   $ (0.18 )
                                 
Weighted average number of common shares outstanding:                                
Basic and Diluted     41,207,444       41,207,444       41,207,444       27,224,514  

 

The accompanying notes are an integral part of these financial statements.

   

3

 

 

BIOLITE HOLDING, INC. AND SUBSIDAIRIES

CONSOLIDATED STATEMENTS OF CASH FLOWS

FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2018 AND 2017

(UNAUDITED)

 

    2018     2017  
Cash flows from operating activities            
Net loss   $ (1,341,767 )   $ (6,467,121 )
Adjustments to reconcile net loss to net cash used in operating activities:                
   Depreciation and amortization     33,240       32,903  
   Loss on sale of investment     287,513       34,043  
   Loss on investment in equity securities     164,649       4,379,650  
   Deferred tax     (242,092 )     (224,762 )
   Foreign currency exchange (gain) loss     -       364,764  
Changes in assets and liabilities:                
   Decrease (increase) in accounts receivable     685       -  
   Decrease (increase) in receivable from collaboration revenue     -       687,165  
   Decrease (increase) in due from related parties     70,600       (1,717 )
   Decrease (increase) in inventory     11,293       2,243  
   Decrease (increase) in prepaid expenses and other deposits     (79,172 )     (37,345 )
   Increase (decrease) in accounts payable     -       (98 )
   Increase (decrease) in accrued expenses and other current liabilities     200,010       (250,703 )
   Increase (decrease) in due to related parties     258,684       1,063,295  
Net cash used in operating activities     (636,357 )     (417,683 )
                 
Cash flows from investing activities                
   Restricted cash     56,012       219,009  
   Net proceeds from sale of investment in equity securities     314,294       128,117  
   Loan to related parties     -       (32,800 )
   Long-term equity investment     -       (8,627,949 )
Net cash provided by (used in) investing activities     370,306       (8,313,623 )
                 
Cash flows from financing activities                
   Issuance of common stock for cash     -       7,681,907  
   Capital contribution from related parties under common control     -       5,904  
   Net proceeds of loan from related parties     91,850       820,000  
   Net proceeds from (repayment of) short-term bank loans     (250,500 )     656,000  
   Net proceeds from (repayment of) short-term borrowing from third-parties     382,764       (98,400 )
   Repayment of long-term bank loans     (28,917 )     (27,815 )
Net cash provided by financing activities     195,197       9,037,596  
                 
Effect of exchange rate changes on cash and cash equivalents     (2,718 )     7,783  
                 
Net increase (decrease) in cash and cash equivalents     (73,572 )     314,073  
                 
Cash and cash equivalents                
Beginning     256,925       100,464  
Ending   $ 183,353     $ 414,537  
                 
Supplemental disclosure of cash flows                
Cash paid during the year for:                
    Income tax   $ -     $ -  
    Interest expense   $ 58,842     $ 89,359  
                 
Non-cash financing and investing activities                
Equity securities received in exchange for payments of collaboration revenues   $ -     $ 5,850,000  

 

The accompanying notes are an integral part of these financial statements.

 

4

 

 

BIOLITE HOLDING, INC. AND SUBSIDIARIES

 NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS

SEPTEMBER 30, 2018

 

 

NOTE 1. ORGANIZATION AND BUSINESS

 

BioLite Holding, Inc. (the “BioLite Holding”) was incorporated under the laws of the State of Nevada on July 27, 2016. BioLite BVI, Inc. (the “BioLite BVI”), a wholly owned subsidiary of BioLite Holding, was incorporated in the British Virgin Islands on September 13, 2016. BioLite Holding and BioLite BVI are holding companies and have not carried out substantive business operations of their own.

 

BioLite, Inc., (the "BioLite Taiwan") was incorporated on February 13, 2006 under the laws of Taiwan. BioLite is in the business of developing and commercialization of new botanical drugs with application in central nervous system, autoimmunity, inflammation, hematology, and oncology. In addition, BioLite Taiwan distributes dietary supplements made from extracts of Chinese herbs and Maitake mushroom.

 

In January 2017, BioLite Holding, BioLite BVI, BioLite Taiwan, and certain shareholders of BioLite Taiwan entered into a share purchase / exchange agreement (the “BioLite Share Purchase / Exchange Agreement”). Pursuant to the BioLite Share Purchase / Exchange Agreement, the shareholder participants to the BioLite Share Purchase / Exchange Agreement have sold their equity in BioLite Taiwan and were using the proceeds from such sales to purchase shares of common stock of BioLite Holding at the same price per share, resulting in their owning the same number of shares of common stock as they owned in the BioLite Taiwan. Upon closing of the Share Purchase/ Exchange Agreement in August 2017, BioLite Holding ultimately owns via BioLite BVI approximately 73% of BioLite Taiwan. The other shareholders who did not enter this Share Purchase/ Exchange Agreement retain their equity ownership in BioLite Taiwan.

 

The fiscal year of BioLite Holding, BioLite BVI, and BioLite Taiwan (collectively referred to as “the Company”) ends on December 31st.

   

NOTE 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

   

Basis of Presentation and Principles of Consolidation — The accompanying consolidated financial statements, including the accounts of BioLite Holding, BioLite BVI, and BioLite Taiwan, have been prepared in conformity with accounting principles generally accepted in the United States of America. Since BioLite Holding, BioLite BVI, and BioLite Taiwan are the entities under Dr. Tsung-Shann Jiang’s common control prior to the Share Purchase / Exchange Agreement, the transaction is accounted for as a restructuring transaction. All the assets and liabilities of BioLite Taiwan were transferred to BioLite Holding at their respective carrying amounts on the closing date of Share Purchase / Exchange transaction. The Company has recast prior period financial statements to reflect the conveyance of BioLite Taiwan’s common shares as if the restructuring transaction had occurred as of the earliest date of the financial statements. All material intercompany accounts, transactions, and profits have been eliminated in consolidation. The nature of and effects on earnings per share (EPS) of nonrecurring intra-entity transactions involving long-term assets and liabilities is not required to be eliminated and EPS amounts have been recast to include the earnings (or losses) of the transferred net assets.

 

The functional currency of BioLite Taiwan is the New Taiwan dollars, however the accompanying consolidated financial statements have been translated and presented in United States Dollars ($). In the accompanying financial statements and notes, “$”, “US$” and “U.S. dollars” mean United States dollars, and “NT$” and “NT dollars” mean New Taiwan dollars. 

 

Going Concern — The accompanying consolidated financial statements have been prepared assuming the Company will continue as a going concern. The Company has incurred losses since its inception resulting in an accumulated deficit of $10,980,204 and $9,971,033 as of September 30, 2018 and December 31, 2017, respectively. The Company also had working capital deficiency of $4,051,163 and $3,327,457 at September 30, 2018 and December 31, 2017, respectively. The ability to continue as a going concern is dependent upon the Company generating profitable operations in the future and/or obtaining the necessary financing to meet its obligations and repay its liabilities arising from normal business operations when they become due. These consolidated financial statements do not include any adjustments to the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should the Company upon signing of that agreement.

 

5

 

 

In order to continue as a going concern, the Company will need, among other things, additional capital resources. Management’s plans to obtain such resources for the Company include (1) obtaining capital from the sale of its equity securities (2) short-term and long-term borrowings from banks and third-parties, and (3) short-term borrowings from stockholders or other related party(ies) when needed. However, management cannot provide any assurance that the Company will be successful in accomplishing any of its plans.

 

The ability of the Company to continue as a going concern is dependent upon its ability to successfully accomplish the plans described in the preceding paragraph and eventually to secure other sources of financing and attain profitable operations.

 

Segment Reporting — The Company follows the provisions of ASC Topic 280, “Segment Reporting”, which establishes standards for reporting information about operating segments, which uses a “management” approach for determining segments. The management approach designates the internal organization that is used by management for making operating decisions and assessing performance as the source of the Company’s reportable segments. ASC Topic 280, “Segment Reporting,” also requires disclosures about products or services, geographic areas, and major customers. The Company’s management reporting structure provided for only one segment during the nine months ended September 30, 2018 and 2017. Accordingly, no separate segment information is presented.

 

Use of Estimates — The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the balance sheet date and the reported amounts of revenue and expenses during the reporting period. Actual results could differ from those estimates.

 

Concentration of Credit Risk — The Company’s financial instruments that are exposed to concentrations of credit risk consist primarily of cash and cash equivalents and restricted cash. The Company places its cash and temporary cash investments in high quality credit institutions in Taiwan, but these investments may be in excess of Taiwan Central Deposit Insurance Corporation’s insurance limits. The Company does not enter into financial instruments for hedging, trading, or speculative purposes. Concentration of credit risk with respect to accounts receivables is limited due to the wide variety of customers and markets in which the Company transacts business, as well as their dispersion across many geographical areas. The Company performs ongoing credit evaluations of its customers and generally does not require collateral, but does require advance deposits on certain transactions.

 

Cash and Cash Equivalents — The Company considers all highly liquid investments with maturities of three months or less at the date of purchase to be cash equivalents.

 

Restricted Cash Equivalents — Restricted cash equivalents primarily consist of cash held in a reserve bank account associated with short-term bank loans.

 

Accounts Receivable and Other Receivables — Accounts receivable and other receivables are stated at carrying value less estimates made for doubtful receivables. An allowance for impairment of trade receivable and other receivables is established if the collection of a receivable becomes doubtful. Such receivable becomes doubtful when there is objective evidence that the Company will not be able to collect all amounts due according to the original terms of the receivables. Significant financial difficulties of the debtor, probability that the debtor will enter into bankruptcy or financial reorganization, and default or delinquency in payments are considered indicators that the receivable is impaired. The amount of the allowance is the difference between the asset’s carrying amount and the present value of estimated future cash flows, discounted at the original effective interest rate.

 

Inventory — Inventory consists of raw materials, work-in-process, finished goods, and merchandise. Inventories are stated at the lower of cost or market and valued on a moving weighted average cost basis. Market is determined based on net realizable value. The Company periodically reviews the age and turnover of its inventory to determine whether any inventory has become obsolete or has declined in value, and incurs a charge to operations for known and anticipated inventory obsolescence.

 

6

 

 

Property and Equipment — Property and equipment is carried at cost net of accumulated depreciation. Repairs and maintenance are expensed as incurred. Expenditures that improve the functionality of the related asset or extend the useful life are capitalized. When property and equipment is retired or otherwise disposed of, the related gain or loss is included in operating income. Leasehold improvements are depreciated on the straight-line method over the shorter of the remaining lease term or estimated useful life of the asset. Depreciation is calculated on the straight-line method, including property and equipment under capital leases, generally based on the following useful lives:

 

    Estimated Life in Years
Buildings and leasehold improvements   5 ~ 50
Machinery and equipment   5 ~ 6
Office equipment   3 ~ 6

 

Impairment of Long-Lived Assets —The Company has adopted Accounting Standards Codification subtopic 360-10, Property, Plant and Equipment (“ASC 360-10”). ASC 360-10 requires that long-lived assets and certain identifiable intangibles held and used by the Company be reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. The Company evaluates its long-lived assets for impairment annually or more often if events and circumstances warrant. Events relating to recoverability may include significant unfavorable changes in business conditions, recurring losses, or a forecasted inability to achieve break-even operating results over an extended period. Should impairment in value be indicated, the carrying value of intangible assets will be adjusted, based on estimates of future discounted cash flows resulting from the use and ultimate disposition of the asset. ASC 360-10 also requires assets to be disposed of be reported at the lower of the carrying amount or the fair value less costs to sell. Management has determined that no impairments of long-lived assets currently exist.

 

Fair Value Measurements — FASB ASC 820, “Fair Value Measurements” defines fair value for certain financial and nonfinancial assets and liabilities that are recorded at fair value, establishes a framework for measuring fair value and expands disclosures about fair value measurements. It requires that an entity measure its financial instruments to base fair value on exit price, maximize the use of observable units and minimize the use of unobservable inputs to determine the exit price. It establishes a hierarchy which prioritizes the inputs to valuation techniques used to measure fair value. This hierarchy increases the consistency and comparability of fair value measurements and related disclosures by maximizing the use of observable inputs and minimizing the use of unobservable inputs by requiring that observable inputs be used when available. Observable inputs are inputs that reflect the assumptions market participants would use in pricing the assets or liabilities based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s own assumptions about the assumptions market participants would use in pricing the asset or liability developed based on the best information available in the circumstances. The hierarchy prioritizes the inputs into three broad levels based on the reliability of the inputs as follows:

 

  Level 1 – Inputs are quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date. Valuation of these instruments does not require a high degree of judgment as the valuations are based on quoted prices in active markets that are readily and regularly available.
     
  Level 2 – Inputs other than quoted prices in active markets that are either directly or indirectly observable as of the measurement date, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
     
  Level 3 – Valuations based on inputs that are unobservable and not corroborated by market data. The fair value for such assets and liabilities is generally determined using pricing models, discounted cash flow methodologies, or similar techniques that incorporate the assumptions a market participant would use in pricing the asset or liability.

 

The carrying values of certain assets and liabilities of the Company, such as cash and cash equivalents, restricted cash, accounts receivable, due from related parties, inventory, prepaid expenses and other current assets, accounts payable, accrued liabilities, and due to related parties approximate fair value due to their relatively short maturities. The carrying value of the Company’s short-term bank loan approximates their fair value as the terms of the borrowing are consistent with current market rates and the duration to maturity is short. The carrying value of the Company’s long-term bank loan approximates fair value because the interest rates approximate market rates that the Company could obtain for debt with similar terms and maturities.

 

7

 

 

Long-term Equity Investment — The Company acquires these equity investments to promote business and strategic objectives. The Company accounts for non-marketable equity and other equity investments for which the Company does not have control over the investees as:

 

Equity method investments when the Company has the ability to exercise significant influence, but not control, over the investee. Its proportionate share of the income or loss is recognized monthly and is recorded in gains (losses) on equity investments.

 

Non-marketable cost method investments when the equity method does not apply.

 

Significant judgment is required to identify whether an impairment exists in the valuation of the Company’s non-marketable equity investments, and therefore the Company considers this a critical accounting estimate. Its yearly analysis considers both qualitative and quantitative factors that may have a significant impact on the investee's fair value. Qualitative analysis of its investments involves understanding the financial performance and near-term prospects of the investee, changes in general market conditions in the investee’s industry or geographic area, and the management and governance structure of the investee. Quantitative assessments of the fair value of its investments are developed using the market and income approaches. The market approach includes the use of comparable financial metrics of private and public companies and recent financing rounds. The income approach includes the use of a discounted cash flow model, which requires significant estimates regarding the investees' revenue, costs, and discount rates. The Company’s assessment of these factors in determining whether an impairment exists could change in the future due to new developments or changes in applied assumptions.

 

Other-Than-Temporary Impairment — The Company’s long-term equity investments are subject to a periodic impairment review. Impairments affect earnings as follows:

 

Marketable equity securities include the consideration of general market conditions, the duration and extent to which the fair value is below cost, and the Company’s ability and intent to hold the investment for a sufficient period of time to allow for recovery of value in the foreseeable future. The Company also considers specific adverse conditions related to the financial health of, and the business outlook for, the investee, which may include industry and sector performance, changes in technology, operational and financing cash flow factors, and changes in the investee’s credit rating. The Company records other-than-temporary impairments on marketable equity securities and marketable equity method investments in gains (losses) on equity investments.

 

Non-marketable equity investments based on the Company’s assessment of the severity and duration of the impairment, and qualitative and quantitative analysis of the operating performance of the investee; adverse changes in market conditions and the regulatory or economic environment; changes in operating structure or management of the investee; additional funding requirements; and the investee’s ability to remain in business. A series of operating losses of an investee or other factors may indicate that a decrease in value of the investment has occurred that is other than temporary and that shall be recognized even though the decrease in value is in excess of what would otherwise be recognized by application of the equity method. A loss in value of an investment that is other than a temporary decline shall be recognized. Evidence of a loss in value might include, but would not necessarily be limited to, absence of an ability to recover the carrying amount of the investment or inability of the investee to sustain an earnings capacity that would justify the carrying amount of the investment. The Company records other-than-temporary impairments for non-marketable cost method investments and equity method investments in gains (losses) on equity investments. Other-than-temporary impairments of equity investments were $0 and $91,047 for the three months ended September 30, 2018 and 2017, respectively. Other-than-temporary impairments of equity investments were $0 and $4,379,456 for the nine months ended September 30, 2018 and 2017, respectively.

 

Post-retirement and post-employment benefits — BioLite Taiwan adopted the government mandated defined contribution plan pursuant to the Labor Pension Act (the “Labor Pension Act ”) in Taiwan. Such labor regulations require that the rate of contribution made by an employer to the Labor Pension Fund per month shall not be less than 6% of the worker's monthly salaries. Pursuant to the Labor Pension Act , the Company makes monthly contribution equal to 6% of employees’ salaries to the employees’ pension fund. The Company has no legal obligation for the benefits beyond the contributions made. The total amounts for such employee benefits, which were expensed as incurred, were $4,806 and $5,978 for the three months ended September 30, 2018 and 2017, respectively. The total amounts for such employee benefits, which were expensed as incurred, were $14,827 and $20,535 for the nine months ended September 30, 2018 and 2017, respectively. Other than the above, the Company does not provide any other post-retirement or post-employment benefits.

 

8

 

 

Revenue Recognition — During the fiscal year 2018, the Company adopted Accounting Standards Codification (“ASC”), Topic 606 (ASC 606), Revenue from Contracts with Customers, using the modified retrospective method to all contracts that were not completed as of January 1, 2018, and applying the new revenue standard as an adjustment to the opening balance of accumulated deficit at the beginning of 2018 for the cumulative effect. The results for the Company’s reporting periods beginning on and after January 1, 2018 are presented under ASC 606, while prior period amounts are not adjusted and continue to be reported under the accounting standards in effect for the prior period. Based on the Company’s review of existing collaborative agreements as of January 1, 2018, the Company concluded that the adoption of the new guidance did not have a significant change on the Company’s revenue during all periods presented.

 

Pursuant to ASC 606, the Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the Company expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines is within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the Company will collect the consideration the Company is entitled to in exchange for the goods or services the Company transfers to the customers. At inception of the contract, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract, determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.

 

The following are examples of when the Company recognizes revenue based on the types of payments the Company receives.

 

Merchandise Sales The Company recognizes net revenues from dietary supplements product sales when customers obtain control of the Company’s products, which typically occurs upon delivery to customer. Product revenues are recorded at the net sales price, or “transaction price,” which includes applicable reserves for variable consideration, including discounts, allowances, and returns.

 

Trade discount and allowances : The Company generally provides invoice discounts on product sales to its customers for prompt payment. The Company estimates that, based on its experience, its customers will earn these discounts and fees, and deducts the full amount of these discounts and fees from its gross product revenues and accounts receivable at the time such revenues are recognized.

 

Product returns : The Company estimates the amount of each product that will be returned and deducts these estimated amounts from its gross revenues at the time the revenues are recognized. The Company’s customers have the right to return unopened packages, subject to contractual limitations.

 

To date, product allowance and returns have been minimal and, based on its experience, the Company believes that returns of its products will continue to be minimal.

 

Collaborative Revenues — The Company recognizes collaborative revenues generated through collaborative research, development and/or commercialization agreements. The terms of these agreements typically include payment to the Company related to one or more of the following: nonrefundable upfront license fees, development and commercial milestones, partial or complete reimbursement of research and development costs, and royalties on net sales of licensed products. Each type of payments results in collaborative revenues except for revenues from royalties on net sales of licensed products, which are classified as royalty revenues. To date, we have not received any royalty revenues. Revenue is recognized upon satisfaction of a performance obligation by transferring control of a good or service to the collaboration partners.

 

9

 

 

As part of the accounting for these arrangements, the Company applies judgment to determine whether the performance obligations are distinct, and develop assumptions in determining the stand-alone selling price for each distinct performance obligation identified in the collaboration agreements. To determine the stand-alone selling price, the Company relies on assumptions which may include forecasted revenues, development timelines, reimbursement rates for R&D personnel costs, discount rates and probabilities of technical and regulatory success.

 

The Company had multiple deliverables under the collaborative agreements, including deliverables relating to grants of technology licenses, regulatory and clinical development, and marketing activities. Estimation of the performance periods of the Company’s deliverables requires the use of management’s judgment. Significant factors considered in management’s evaluation of the estimated performance periods include, but are not limited to, the Company’s experience in conducting clinical development, regulatory and manufacturing activities. The Company reviews the estimated duration of its performance periods under its collaborative agreements on an annually basis, and makes any appropriate adjustments on a prospective basis. Future changes in estimates of the performance period under its collaborative agreements could impact the timing of future revenue recognition.

 

(v) Nonrefundable upfront payments

 

If a license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in an arrangement, the Company recognizes revenue from the related nonrefundable upfront payments based on the relative standalone selling price prescribed to the license compared to the total selling price of the arrangement. The revenue is recognized when the license is transferred to the collaboration partners and the collaboration partners are able to use and benefit from the license. To date, the receipt of nonrefundable upfront fees was solely for the compensation of past research efforts and contributions made by the Company before the collaborative agreements entered into and it does not relate to any future obligations and commitments made between the Company and the collaboration partners in the collaborative agreements.

 

(vi) Milestone payments

  

The Company is eligible to receive milestone payments under the collaborative agreement with collaboration partners based on achievement of specified development, regulatory and commercial events. Management evaluated the nature of the events triggering these contingent payments, and concluded that these events fall into two categories: (a) events which involve the performance of the Company’s obligations under the collaborative agreement with collaboration partners, and (b) events which do not involve the performance of the Company’s obligations under the collaborative agreement with collaboration partners.

 

The former category of milestone payments consists of those triggered by development and regulatory activities in the territories specified in the collaborative agreements. Management concluded that each of these payments constitute substantive milestone payments. This conclusion was based primarily on the facts that (i) each triggering event represents a specific outcome that can be achieved only through successful performance by the Company of one or more of its deliverables, (ii) achievement of each triggering event was subject to inherent risk and uncertainty and would result in additional payments becoming due to the Company, (iii) each of the milestone payments is nonrefundable, (iv) substantial effort is required to complete each milestone, (v) the amount of each milestone payment is reasonable in relation to the value created in achieving the milestone, (vi) a substantial amount of time is expected to pass between the upfront payment and the potential milestone payments, and (vii) the milestone payments relate solely to past performance. Based on the foregoing, the Company recognizes any revenue from these milestone payments in the period in which the underlying triggering event occurs.

 

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(vii) Multiple Element Arrangements

 

The Company evaluates multiple element arrangements to determine (1) the deliverables included in the arrangement and (2) whether the individual deliverables represent separate units of accounting or whether they must be accounted for as a combined unit of accounting. This evaluation involves subjective determinations and requires management to make judgments about the individual deliverables and whether such deliverables are separate from other aspects of the contractual relationship. Deliverables are considered separate units of accounting provided that: (i) the delivered item(s) has value to the customer on a standalone basis and (ii) if the arrangement includes a general right of return relative to the delivered item(s), delivery or performance of the undelivered item(s) is considered probable and substantially within its control. In assessing whether an item under a collaboration has standalone value, the Company considers factors such as the research, manufacturing, and commercialization capabilities of the collaboration partner and the availability of the associated expertise in the general marketplace. The Company also considers whether its collaboration partners can use the other deliverable(s) for their intended purpose without the receipt of the remaining element(s), whether the value of the deliverable is dependent on the undelivered item(s), and whether there are other vendors that can provide the undelivered element(s).

 

The Company recognizes arrangement consideration allocated to each unit of accounting when all of the revenue recognition criteria in ASC 606 are satisfied for that particular unit of accounting. In the event that a deliverable does not represent a separate unit of accounting, the Company recognizes revenue from the combined unit of accounting over the Company’s contractual or estimated performance period for the undelivered elements, which is typically the term of the Company’s research and development obligations. If there is no discernible pattern of performance or objectively measurable performance measures do not exist, then the Company recognizes revenue under the arrangement on a straight-line basis over the period the Company is expected to complete its performance obligations. Conversely, if the pattern of performance in which the service is provided to the customer can be determined and objectively measurable performance measures exist, then the Company recognizes revenue under the arrangement using the proportional performance method. Revenue recognized is limited to the lesser of the cumulative amount of payments received or the cumulative amount of revenue earned, as determined using the straight-line method or proportional performance method, as applicable, as of the period ending date.

 

At the inception of an arrangement that includes milestone payments, the Company evaluates whether each milestone is substantive and at risk to both parties on the basis of the contingent nature of the milestone. This evaluation includes an assessment of whether: (1) the consideration is commensurate with either the Company’s performance to achieve the milestone or the enhancement of the value of the delivered item(s) as a result of a specific outcome resulting from its performance to achieve the milestone, (2) the consideration relates solely to past performance and (3) the consideration is reasonable relative to all of the deliverables and payment terms within the arrangement. The Company evaluates factors such as the scientific, clinical, regulatory, commercial, and other risks that must be overcome to achieve the particular milestone and the level of effort and investment required to achieve the particular milestone in making this assessment. There is considerable judgment involved in determining whether a milestone satisfies all of the criteria required to conclude that a milestone is substantive. Milestones that are not considered substantive are recognized as earned if there are no remaining performance obligations or over the remaining period of performance, assuming all other revenue recognition criteria are met.

 

(viii) Royalties and Profit Sharing Payments

  

Under the collaborative agreement with the collaboration partners, the Company is entitled to receive royalties on sales of products, which is at certain percentage of the net sales. The Company recognizes revenue from these events based on the revenue recognition criteria set forth in ASC 606. Based on those criteria, the Company considers these payments to be contingent revenues, and recognizes them as revenue in the period in which the applicable contingency is resolved.

 

Income Taxes — Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carry forwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date.

 

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Valuation of Deferred Tax Assets — A valuation allowance is recorded to reduce the Company’s deferred tax assets to the amount that is more likely than not to be realized. In assessing the need for the valuation allowance, management considers, among other things, projections of future taxable income and ongoing prudent and feasible tax planning strategies. If the Company determines that sufficient negative evidence exists, then it will consider recording a valuation allowance against a portion or all of the deferred tax assets in that jurisdiction. If, after recording a valuation allowance, the Company’s projections of future taxable income and other positive evidence considered in evaluating the need for a valuation allowance prove, with the benefit of hindsight, to be inaccurate, it could prove to be more difficult to support the realization of its deferred tax assets. As a result, an additional valuation allowance could be required, which would have an adverse impact on its effective income tax rate and results. Conversely, if, after recording a valuation allowance, the Company determines that sufficient positive evidence exists in the jurisdiction in which the valuation allowance was recorded, it may reverse a portion or all of the valuation allowance in that jurisdiction. In such situations, the adjustment made to the deferred tax asset would have a favorable impact on its effective income tax rate and results in the period such determination was made. See Note 13 for information related to income taxes, including the recorded balances of its valuation allowance related to deferred tax assets.

 

The Company applied the provisions of ASC 740-10-50, “Accounting For Uncertainty In Income Taxes”, which provides clarification related to the process associated with accounting for uncertain tax positions recognized in its financial statements. Audit periods remain open for review until the statute of limitations has passed. The completion of review or the expiration of the statute of limitations for a given audit period could result in an adjustment to the Company’s liability for income taxes. Any such adjustment could be material to the Company’s results of operations for any given quarterly or annual period based, in part, upon the results of operations for the given period. As of September 30, 2018 and December 31, 2017, management considered that the Company had no uncertain tax positions, and will continue to evaluate for uncertain positions in the future.

 

Share-Based Compensation — The Company recognizes share-based compensation expense for share-based compensation awards granted to its employees and officers. Compensation expense for share-based compensation awards granted is based on the grant date fair value estimate for each award as determined by its board of directors. The Company recognizes these compensation costs on a straight-line basis over the requisite service period of the award, which is generally one to two years. As share-based compensation expense recognized is based on awards ultimately expected to vest, such expense is reduced for estimated forfeitures.

 

The Company estimates the fair value of share-based compensation awards at the date of grant using the Black-Scholes option pricing model, which requires the input of highly subjective assumptions, including the fair value of the underlying common stock, expected term of the option, expected volatility of the price of its common stock, risk-free interest rates, and the expected dividend yield of its common stock. The assumptions used in the Company’s option-pricing model represent management’s best estimates. These estimates involve inherent uncertainties and the application of management’s judgment. If factors change and different assumptions are used, the Company’s stock-based compensation expense could be materially different in the future.

 

These assumptions and estimates are as follows:

 

Fair value of the underlying common stock. Because the Company's stocks are not publicly traded, the assumptions used in the valuation model are based on future expectations combined with management judgment. In the absence of a public trading market, the board of directors, with input from management, exercised significant judgment and considered numerous objective and subjective factors to determine the fair value of its common stock as of the date of each option grant, including the following factors:

 

a) contemporaneous valuations performed by unrelated third-party specialists;

 

b) the lack of marketability of its common stock;

 

c) the Company's actual operating and financial performance, and current business conditions and projections;

 

d) the Company's hiring of key personnel and the experience of its management;

 

e) the Company's history and the timing of the introduction of new products and services;

 

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In valuing the common stock, the fair value of the underlying common stock was determined by using the value indications under a combination of valuation approaches, including a discounted cash flow analysis under the income approach, market approaches, and the latest round of equity financing at grant date

 

Expected term. The expected term represents the period that the stock-based compensation awards are expected to be outstanding. Since the Company did not have sufficient historical information to develop reasonable expectations about future exercise behavior, it used the simplified method to compute expected term, which represents the average of the time-to-vesting and the contractual life.

 

Expected volatility. As the Company does not have a trading history for its common stock, the expected stock price volatility for its common stock was estimated by taking the mean standard deviation of stock prices for selected companies in biotechnogy industry listed in Taiwan’s stock markets.

 

Risk-free interest rate. The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the time of grant for zero coupon U.S. Treasury notes with maturities approximately equal to the expected term of the options.

 

Expected dividend yield. The Company has never declared or paid any cash dividends and do not presently plan to declare or pay cash dividends in the foreseeable future. Consequently, the Company used an expected dividend yield of zero.

 

The valuations are highly complex and subjective. Following the completion of this offering, common stock valuations will no longer be necessary as the Company will rely on market prices to determine the fair value of its common stock.

 

Foreign-currency Transactions — For the Company’s subsidiaries in Taiwan, the foreign-currency transactions are recorded in New Taiwan dollars (“NTD”) at the rates of exchange in effect when the transactions occur. Gains or losses resulting from the application of different foreign exchange rates when cash in foreign currency is converted into New Taiwan dollars, or when foreign-currency receivables or payables are settled, are credited or charged to income in the year of conversion or settlement. On the balance sheet dates, the balances of foreign-currency assets and liabilities are restated at the prevailing exchange rates and the resulting differences are charged to current income except for those foreign currencies denominated investments in shares of stock where such differences are accounted for as translation adjustments under Equity.

 

Translation Adjustment — The accounts of BioLite Taiwan was maintained, and its financial statements were expressed, in New Taiwan Dollar (“NT$”). Such financial statements were translated into U.S. Dollars (“$” or “USD”) in accordance ASC 830, "Foreign Currency Matters", with the NT$ as the functional currency. According to the Statement, all assets and liabilities are translated at the current exchange rate, stockholder's deficit are translated at the historical rates and income statement items are translated at an average exchange rate for the period. The resulting translation adjustments are reported under other comprehensive income (loss) as a component of stockholders’ equity (deficit).

 

Research and Development — The Company accounts for research and development expenses in accordance with Accounting Standards Codification (“ASC”) 730, Research and Development (“ASC 730”). Research and development expenses are charged to expense as incurred unless there is an alternative future use in other research and development projects or otherwise. Research and development expenses are comprised of costs incurred in performing research and development activities, including personnel-related costs, share-based compensation, and facilities-related overhead, outside contracted services including clinical trial costs, manufacturing and process development costs for both clinical and preclinical materials, research costs, upfront and development milestone payments under collaborative agreements and other consulting services. Non-refundable advance payment for goods and services that will be used in future research and development activities are expensed when the activity has been performed or when the goods have been received rather than when the payment is made. In instances where the Company enters into agreements with third parties to provide research and development services, costs are expensed as services are performed. Amounts due under such arrangements may be either fixed fee or fee for service, and may include upfront payments, monthly payments, and payments upon the completion of milestones or receipt of deliverables. Research and development expense were $10,213 and $52,293 for the three months ended September 30, 2018 and 2017, respectively. Research and development expense were $224,316 and $232,613 for the nine months ended September 30, 2018 and 2017, respectively.

 

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Promotional and Advertising Costs Promotional and advertising costs are classified as selling and general and administrative expenses, and are expensed as incurred. Promotional and advertising expenses consist primarily of the costs of designing, producing, and distributing materials promoting the Company and its products, including its corporate website. Promotional and advertising costs were $173 and $2 for the three months ended September 30, 2018 and 2017, respectively. Promotional and advertising costs were $173 and $675 for the nine months ended September 30, 2018 and 2017, respectively.

 

Statement of Cash Flows Cash flows from the Company's operations are based upon the local currencies. As a result, amounts related to assets and liabilities reported on the statement of cash flows will not necessarily agree with changes in the corresponding balances on the balance sheet.

 

Comprehensive Income (Loss) — Comprehensive income (loss) includes accumulated foreign currency translation gains and losses. The Company has reported the components of comprehensive income (loss) in its statements of operations and comprehensive income (loss).

 

Reclassifications — Certain classifications have been made to the prior year financial statements to conform to the current year presentation. The reclassification had no impact on previously reported net loss or accumulated deficit.

 

Recently Issued Accounting Pronouncements — In February 2016, the FASB issued ASU No. 2016-02, “Leases.” The core principle of the ASU is that a lessee should recognize the assets and liabilities that arise from its leases other than those that meet the definition of a short-term lease. The ASU requires extensive qualitative and quantitative disclosures, including with respect to significant judgments made by management. Subsequently, the FASB issued ASU No. 2017-13, in September 2017 and ASU No. 2018-01, in January 2018, which amends and clarifies ASU 2016-02. The ASU will be effective for the Company beginning January 1, 2019, including interim periods in the fiscal year 2019. Early adoption is permitted. The Company is in the process of determining the method of adoption and assessing the impact of this ASU on its consolidated results of operations, cash flows, financial position and disclosures.

 

On December 22, 2017, the SEC issued Staff Accounting Bulletin (“SAB 118”), which provides guidance on accounting for tax effects of the Tax Act. SAB 118 provides a measurement period that should not extend beyond one year from the Tax Act enactment date for companies to complete the accounting under ASC 740. In accordance with SAB 118, a company must reflect the income tax effects of those aspects of the Act for which the accounting under ASC 740 is complete. In March 2018, the FASB issued ASU 2018-05, Amendments to SEC Paragraphs Pursuant to SEC Staff Accounting Bulletin No. 118 (SEC Update), Income Taxes (Topic 740). ASU 2018-05 provides guidance regarding the recording of tax impacts where uncertainty exists, in the period of adoption of the 2017 U.S. Tax Cuts and Jobs Act (the “2017 Tax Act”).To the extent that a company’s accounting for certain income tax effects of the Tax Act is incomplete but it is able to determine a reasonable estimate, it must record a provisional estimate to be included in the financial statements. If a company cannot determine a provisional estimate to be included in the financial statements, it should continue to apply ASC 740 on the basis of the provision of the tax laws that were in effect immediately before the enactment of the Tax Act. While the Company is able to make reasonable estimates of the impact of the reduction in corporate rate and the deemed repatriation transition tax, the final impact of the Tax Act may differ from these estimates, due to, among other things, changes in its interpretations and assumptions, additional guidance that may be issued by the I.R.S., and actions the Company may take. The Company is continuing to gather additional information to determine the final impact.

 

In February 2018, the FASB issued Accounting Standards Update No. 2018-02 (ASU 2018-02), Income Statement - Reporting Comprehensive Income (Topic 220). The guidance in ASU 2018-02 allows an entity to elect to reclassify the stranded tax effects related to the Tax Cuts and Jobs Act (the Tax Act) of 2017 from accumulated other comprehensive income into retained earnings. ASU 2018-02 is effective for fiscal years beginning after December 15, 2018, with early adoption permitted. Early adoption of the amendments in this Update is permitted, including adoption in any interim period, (1) for public business entities for reporting periods for which financial statements have not yet been issued and (2) for all other entities for reporting periods for which financial statements have not yet been made available for issuance. The amendments in this Update should be applied either in the period of adoption or retrospectively to each period (or periods) in which the effect of the change in the U.S. federal corporate income tax rate in the Tax Cuts and Jobs Act is recognized. The Company is currently evaluating the impact of adopting this new guidance on its financial position, results of operations, statement of comprehensive income, and cash flows.

 

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In June 2018, the FASB issued ASU 2018-07, Compensation-Stock Compensation (Topic 718), Improvements to Nonemployee Share-based Payments (“ASU 2018-07”). This ASU expands the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees. The effective date for the standard is for interim periods in fiscal years beginning after December 15, 2018, with early adoption permitted, but no earlier than the Company's adoption date of Topic 606. U nder the new guidance, the measurement of nonemployee equity awards is fixed on the grant date.  The new guidance is required to be applied retrospectively with the cumulative effect recognized at the date of initial application. The Company is currently evaluating the effect ASU 2018-07 will have on the condensed consolidated financial statements.

 

In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (“Topic 820”): Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement. The ASU modifies the disclosure requirements in Topic 820, Fair Value Measurement, by removing certain disclosure requirements related to the fair value hierarchy, modifying existing disclosure requirements related to measurement uncertainty and adding new disclosure requirements, such as disclosing the changes in unrealized gains and losses for the period included in other comprehensive income for recurring Level 3 fair value measurements held at the end of the reporting period and disclosing the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements. This ASU is effective for public companies for annual reporting periods and interim periods within those annual periods beginning after December 15, 2019. The Company is currently evaluating the effect, if any, that the ASU will have on its financial statements.

 

NOTE 3. COLLABORATIVE AGREEMENTS

 

(a) Collaborative agreements with BHK

 

(i)       On February 24, 2015, BioLite Taiwan and BioHopeKing Corporation (the “BHK”) entered into a co-development agreement, (the “BHK Co-Development Agreement”), pursuant to which it is collaborative with BHK to develop and commercialize BLI-1401-2 (Botanical Drug) Triple Negative Breast Cancer (TNBC) Combination Therapy (BLI-1401-2 Products) in Asian countries excluding Japan for all related intellectual property rights, and has developed it for medicinal use in collaboration with outside researchers. The development costs shall be shared 50/50 between BHK and the Company. The BHK Co-Development Agreement will remain in effect for fifteen years from the date of first commercial sale of the Product in in Asia excluding Japan.

 

On July 27, 2016, BioLite Taiwan and BHK agreed to amend the payment terms of the milestone payment in an aggregate amount of $10 million based on the following schedule:

 

· Upon the signing of the BHK Co-Development Agreement: $1 million, or 10% of total payment

 

· Upon the first Investigational New Drug (IND) submission and BioLite Taiwan will deliver all data to BHK according to FDA Reviewing requirement: $1 million, or 10% of total payment

 

· At the completion of first phase II clinical trial: $1 million, or 10% of total payment

 

· At the initiation of phase III of clinical trial research: $3 million, or 30% of total payment

 

· Upon the New Drug Application (NDA) submission: $4 million, or 40% of total payment

 

In December 2015, BHK has paid a non-refundable upfront cash payment of $1 million, or 10% of $10,000,000, upon the signing of BHK Co-Development Agreement. The Company concluded that the deliverables are considered separate units of accounting as the delivered items have value to the customer on a standalone basis and recognized this cash receipt as collaboration revenue when all research, technical, and development data was delivered to BHK in 2015. The receipt is for the compensation of past research efforts and contributions made by BioLite Taiwan before this collaborative agreement was signed and it does not relate to any future commitments made by BioLite Taiwan and BHK in this collaborative agreement. In August 2016, the Company has received the second milestone payment of NT$31,649,000, approximately equivalent to $1 million, and recognized collaboration revenue in the same year. As of the date of this report, the Company has not completed the first phase II clinical trial.

 

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In addition to the milestone payments, BioLite Taiwan is entitled to receive royalty on 12% of BHK’s net sales related to BLI-1401-2 Products. As of September 30, 2018 and December 31, 2017, the Company has not earned the royalty under the BHK Co-Development Agreement.

 

(ii)      On December 9, 2015, BioLite Taiwan entered into another two collaborative agreements (the “BHK Collaborative Agreements”), pursuant to which it is collaborative with BHK to co-develop and commercialize BLI-1005 for “Targeting Major Depressive Disorder” (BLI-1005 Products) and BLI-1006 for “Targeting Inflammatory Bowel Disease” (BLI-1006 Products) in Asia excluding Japan for all related intellectual property rights, and has developed it for medicinal use in collaboration with outside researchers. The development costs shall be shared 50/50 between BHK and the Company. The BHK Collaborative Agreements will remain in effect for fifteen years from the date of first commercial sale of the Product in Asia excluding Japan.

 

In 2015, the Company recognized the cash receipt in a total of NT$50 million, approximately equivalent to $1.71 million, as collaboration revenue when all research, technical, and development data was delivered to BHK. The Company concluded that the deliverables are considered separate units of accounting as the delivered items have value to the customer on a standalone basis and recognized this payment as collaboration revenue when all research, technical, data and development data was delivered to BHK. The cash receipt is for the compensation of past research efforts and contributions made by BioLite Taiwan before the BHK Collaborative Agreements were signed and it does not relate to any future commitments made by BioLite Taiwan and BHK in this BHK Collaborative Agreements.

 

In addition to the total of NT$50 million, approximately equivalent to $1.71 million, BioLite Taiwan is entitled to receive 50% of the future net licensing income or net sales profit. As of September 30, 2018 and December 31, 2017, the Company has not earned the royalty under the BHK Collaborative Agreements.

 

(b) Collaborative Agreement with BriVision

 

On December 29, 2015, BioLite Taiwan and BriVision entered into a collaborative agreement (the “BriVision Collaborative Agreement”), pursuant to which it is collaborative with BriVision to develop and commercialize five products, including BLI-1005 CNS-Major Depressive Disorder, BLI-1008 CNS-Attention Deficit Hyperactivity Disorder, BLI-1401-1 Anti-Tumor Combination Therapy-Solid Tumor with Anti-PD-1, BLI-1401-2 Anti-Tumor Combination Therapy-Triple Negative Breast Cancer, and BLI-1501 Hematology-Chronic Lymphocytic Leukemia ( collectively “Five Products”) in the United States of America and Canada for all related intellectual property rights, and has developed it for medicinal use in collaboration with outside researchers. On January 12, 2017, BioLite Taiwan entered into an Addendum (the “Addendum”) to the BriVision Collaborative Agreement, pursuant to which BioLite Taiwan and BriVision agreed to include one more product, namely, “Maitake Combination Therapy” as one of the Products defined in the BriVision Collaborative Agreement (the “Sixth Product”) and defined the Territory of the Sixth Product to be worldwide and restate the Territory of the Five Products to be the U.S.A and Canada. The BriVision Collaborative Agreement will remain in effect for fifteen years from the date of first commercial sale of the Five Products in the North America Region. Either party may terminate upon thirty days’ prior written notice for breach or insolvency.

 

Under the BriVision Collaborative Agreement, BriVision should pay a total of $100,000,000 in cash or stock of BriVision with equivalent value, according to the following schedule:

 

· Upfront payment shall be made upon the signing of this BriVision Collaborative Agreement: 3.5% of total payment. After receiving upfront payment from BriVision, BioLite Taiwan has to deliver all data to BriVision in one week.
· Upon the first IND submission, BriVision shall pay, but no later than December 15, 2016: 6.5% of total payment. After receiving second payment from BriVision, BioLite has to deliver IND package to BriVision in one week.
· At the completion of first phase II clinical trial, BriVision shall pay, but no later than September 15, 2017: 15% of total payment. After receiving third payment from BriVision, BioLite has to deliver phase II clinical study report to BriVision in three months.
· Upon the phase III IND submission, BriVision shall pay, but no later than December 15, 2018: 20% of total payment. After receiving forth payment from BriVision, BioLite has to deliver IND package to BriVision in one week.
· At the completion of phase III, BriVision shall pay, but no later than September 15, 2019:25% of total payment. After receiving fifth payment from BriVision, BioLite has to deliver phase III clinical study report to BriVision in three months.
· Upon the NDA submission, BriVision shall pay, but no later than December 15, 2020, BriVision shall pay: 30% of total payment. After receiving sixth payment from BriVision, BioLite has to deliver NDA package to BriVision in one week.

 

An upfront payment of $3,500,000 (the “Milestone Payment”), or 3.5% of $100,000,000, was due in December 2015 under the BriVision Collaborative Agreement. On May 6, 2016, BioLite Taiwan and BriVision amended the payment terms under the BriVision Collaborative Agreement, whereby BriVision has agreed to pay the upfront payment to the Company $2,600,000 in cash and $900,000 in newly issued shares of common stock of BriVision’s holding company, American BriVision (Holding) Corporation (“ABVC”), a Nevada company, at the price of $1.60 per share, for an aggregate number of 562,500 shares. The cash payment and shares issuance were completed in June 2016. The Company concluded that the deliverables are considered separate units of accounting as the delivered items have value to the customer on a standalone basis. The receipt is for the compensation of past research efforts and contributions made by BioLite Taiwan before this collaborative agreement was signed and it does not relate to any future commitments made by BioLite Taiwan and BriVision in this collaborative agreement.

 

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In March 2016, BioLite Taiwan has submitted the first IND and delivered the IND package to BriVision. In February 2017, BriVision agreed to pay the 6.5% of total payment, $6,500,000 to BioLite Taiwan with $650,000 in cash and $5,850,000 in the form of newly issued shares of common stock of ABVC, at the price of $2.0 per share based on the quoted price (for the shares) provided by OTC Markets Group Inc., for an aggregate number of 2,925,000 shares. Since the common stock shares of ABVC are lightly traded in the over-the-counter market, the Company considered to utilize other fair value inputs, such as the bid-ask spread, in determining the fair value of the shares as of September 30, 2018 and December 31, 2017.

 

Since both BioLite Taiwan, BriVision, and ABVC are related parties and under common control by Dr. Tsung-Shann Jiang, the Company has recorded the full amount of $6,500,000 and $3,500,000 in connection with the BriVision Collaborative Agreement as additional paid-in capital.

 

As of the date of this report, the first phase II clinical trial research has not completed yet. Under the BriVision Collaborative Agreement, BioLite Taiwan is also entitled to 5% of net sales of the Products. There have not been any commercial sales since the BriVision Collaborative Agreement became effective. 

 

The Company evaluated the various collaboration agreements in accordance with the provisions of ASC Topic 606. The Company’s arrangement with BHK contains the following deliverables: (i) the license right to develop and use proprietary technology and confidential information for BLI-1401-2 Products, and its related intellectual property rights (the “BLI-1401-2 Deliverable”), (ii)  the license right to develop and use proprietary technology and confidential information for BLI-1005 Products, and its related intellectual property rights (the “BLI-1005 Deliverable”), and (iii) the license right to develop and use proprietary technology and confidential information for BLI-1006 Products, and its related intellectual property rights (the “BLI-1006 Deliverable”). The Company’s arrangement with BriVision contains the license right to develop and use proprietary technology and confidential information for the Five Products and the Sixth Product, and their related intellectual property rights (the “Five Products and the Sixth Product Deliverable).

 

The Company has concluded that each of herein deliverables identified at the inception of the arrangement has standalone value from each of the elements based on their nature. Factors considered in this determination included, among other things, the capabilities of the collaboration partner, whether any other vendor sells the item separately, whether the value of the deliverable is dependent on the other elements in the arrangement, whether there are other vendors that can provide the items and if the customer could use the item for its intended purpose without the other deliverables in the arrangement. Additionally, the Collaboration Agreements do not include a general right of return. Accordingly, each of herein deliverables included in the BHK and BriVision arrangements qualifies as a separate unit of accounting. Therefore, the Company has identified seven units of accounting in connection with its obligations under the collaboration arrangement with BHK and BriVision as follows: (i) BLI-1005 Products, (ii) BLI-1006 Products, (iii) BLI-1008 Products, (iv) BLI-1401-1 Products, (v) BLI-1401-2 Products, (vi) BLI-1401-2 Products, and (vii) Maitake Product (the Sixth Product).

 

NOTE 4. INVENTORY

 

Inventory consists of the following:

 

    September 30,
 2018
    December 31,
 2017
 
    (UNAUDITED)        
Merchandise   $ 4,851     $ 4,951  
Finished goods     101,045       104,454  
Work-in-process     20,305       20,885  
Raw materials     56,864       69,418  
Inventory, net   $ 183,065     $ 199,708  

  

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NOTE 5. LONG-TERM INVESTMENTS

 

(1) The ownership percentages of each investee are listed as follows:

 

    Ownership percentage      
    September 30,     December  31,     Accounting  
Name of related party   2018     2017     treatment
Braingenesis Biotechnology Co., Ltd.     0.23 %     0.23 %   Cost Method
Genepharm Biotech Corporation     0.98 %     0.98 %   Cost Method
BioHopeKing Corporation     6.93 %     9.60 %   Cost Method
BioFirst Corporation     21.51 %     21.51 %   Equity Method
American BriVision (Holding) Corp.     2.32 %     2.32 %   Equity Method
Rgene Corporation     13.04 %     13.04 %   Equity Method

 

(2) The extent the investee relies on the company for its business are summarized as follows:

 

Name of related party   The extent the investee relies on the Company for its business
     
Braingenesis Biotechnology Co., Ltd.   No specific business relationship
Genepharm Biotech Corporation   No specific business relationship
BioHopeKing Corporation   Collaborating with the Company to develop and commercialize drugs
American BriVision (Holding) Corp.   Collaborating with the Company to develop and commercialize drugs
Rgene Corporation   Loaned to the investee
BioFirst Corporation   Loaned from the investee and provides research and development support service

  

(3) Long-term investment mainly consists of the following:

 

    September 30,
 2018
   

December 31,

2017

 
Non-marketable Cost Method Investments     (UNAUDITED)          
    Braingenesis Biotechnology Co., Ltd.   $ 7,235     $ 7,442  
    Genepharm Biotech Corporation     22,089       22,720  
    BioHopeKing Corporation (See NOTE 3)     1,607,639       2,261,524  
          Sub total     1,636,963       2,291,686  
Equity Method Investments                
    BioFirst Corporation (NOTE 12)     1,679,915       1,894,283  
    American BriVision (Holding) Corp. (See NOTE 3 & 12)     -       -  
    Rgene Corporation (NOTE 12)     -       -  
              Total   $ 3,316,878     $ 4,185,969  

 

18

 

 

 

(a) BioFirst Corporation (the “BioFirst):

The Company holds an equity interest in BioFirst Corporation, (the “BioFirst”), accounting for its equity interest using the equity method to accounts for its equity investment as prescribed in ASC 323, Investments—Equity Method and Joint Ventures (“ASC 323”). Equity method adjustments include the Company’s proportionate share of investee’s income or loss and other adjustments required by the equity method. As of September 30, 2018 and December 31, 2017, the Company owns 21.51% common stock shares of BioFirst.

  

Summarized financial information for the Company's equity method investee, BioFirst, is as follows:

 

Balance Sheets          

 

    September 30,
 2018
   

December 31, 2017

 
      (UNAUDITED)          
Current Assets   $ 7,630,555     $ 6,903,042  
Noncurrent Assets     1,753,483       2,730,701  
Current Liabilities     1,068,368       318,074  
Shareholders' Equity     8,315,670       9,315,669  

 

Statements of operation                

 

    Nine Months Ended
September 30,
 
    2018     2017  
    (UNAUDITED)  
Net sales   $ 33,304     $ 3,010,216  
Gross profit     6,590       2,991,886  
Net profit (loss)     (766,425 )     1,941,848  
Share of profit (losses) from investments accounted for using the equity method     (164,649 )     413,873  

 

(b) American BriVision (Holding) Corp. (the “ABVC”):

Both ABVC and the Company are under common control by Dr. Tsung-Shann Jiang, the CEO and chairman of the Company. Since Dr. Tsung-Shann Jiang is able to exercise significant influence, but not control, over the American BriVision (Holding) Corp., (the “ABVC”), the Company determined to use the equity method to accounts for its equity investment as prescribed in ASC 323, Investments—Equity Method and Joint Ventures (“ASC 323”). Equity method adjustments include the Company’s proportionate share of investee’s income or loss and other adjustments required by the equity method. As of September 30, 2018 and December 31, 2017, the Company owns 2.32% common stock shares of ABVC.

  

19

 

 

Summarized financial information for the Company's equity method investee, ABVC, is as follows:

 

Balance Sheets

 

   

September 30,

  2018

   

December 31,

2017

 
      (UNAUDITED)          
Current Assets   $ 2,594,389     $ 2,643,332  
Current Liabilities     4,478,531       4,400,247  
Noncurrent Liabilities     564,567       -  
Shareholders' Equity (Deficit)     (2,448,709 )     (1,756,915 )

 

Statements of operation

 

    Nine Months Ended
September 30,
 
    2018     2017  
    (UNAUDITED)  
Net sales   $ -     $ -  
Gross Profit     -       -  
Net loss     (795,195 )     (3,861,646 )
Share of loss from investments accounted for using the equity method     -       -  

 

(c) Rgene Corporation (the “Rgene”):

Both Rgene and the Company are under common control by Dr. Tsung-Shann Jiang, the CEO and chairman of the Company. Since Dr. Tsung-Shann Jiang is able to exercise significant influence, but not control, over the Rgene, the Company determined to use the equity method to accounts for its equity investment as prescribed in ASC 323, Investments—Equity Method and Joint Ventures (“ASC 323”). Equity method adjustments include the Company’s proportionate share of investee’s income or loss and other adjustments required by the equity method. As of September 30, 2018 and December 31, 2017, the Company owns 13.04% common stock shares of Rgene.

 

Summarized financial information for the Company's equity method investee, Rgene, is as follows:

 

Balance Sheets

 

   

September 30,

2018

   

December 31,

2017

 
      (UNAUDITED)          
Current Assets   $ 37,543     $ 48,557  
Noncurrent Assets     14,839       81  
Current Liabilities     3,205,516       3,118,897  
Shareholders' Equity (Deficit)     (3,153,134 )     (3,070,259 )

  

20

 

 

Statements of operation

 

    Nine Months Ended
September 30,
 
    2018     2017  
    (UNAUDITED)  
Net sales   $ -     $ -  
Gross Profit     -       -  
Net loss     (188,933 )     (3,174,653 )
Share of loss from investments accounted for using the equity method     -       (414,067 )

 

(4) Disposition of long-term investment

 

During the nine months ended September 30, 2018, the Company sold 347,000 shares of common stock of BioHopeKing Corporation (the “BHK”) at prices ranging from NT$25, equivalent $0.84, to NT$30, equivalent $1.00, to two directors of BHK. As a result of the transactions, the Company recognized investment loss of $287,513 for the same period.

 

On November 2, 2018, the Company subsequently purchased an aggregate of 366,200 shares of common stock of BHK at NT$50, equivalent $1.67, from eleven shareholders of BHK. The percentage of ownership accordingly increased to 9.74% as of November 2, 2018.

 

(5) Losses on Equity Investments

 

The components of losses on equity investments for each period were as follows:

 

    For the Nine Months Ended September 30,  
    2018     2017  
    (UNAUDITED)  
Share of equity method investee losses   $ (164,649 )   $ (194 )
Impairments     -       (4,379,456 )
Total losses on equity investments   $ (164,649 )   $ (4,379,650 )

 

NOTE 6. PROPERTY AND EQUIPMENT

 

Property and equipment as of September 30, 2018 and December 31, 2017 are summarized as follows:

 

   

September 30,

2018

    December 31,
2017
 
    (UNAUDITED)        
Land   $ 364,527     $ 374,953  
Buildings and leasehold improvements     291,291       299,623  
Machinery and equipment     87,623       90,130  
Office equipment     21,357       21,968  
      764,798       786,674  
Less: accumulated depreciation     (242,731 )     (216,098 )
Property and equipment, net   $ 522,067     $ 570,576  

 

Depreciation expenses were $10,569 and $11,034 for the three months ended September 30, 2018 and 2017, respectively. Depreciation expenses were $33,240 and $32,903 for the nine months ended September 30, 2018 and 2017, respectively.

 

21

 

 

 

NOTE 7. BANK LOANS

 

(1) Short-term bank loan consists of the following:

 

    September 30,     December 31,  
    2018     2017  
    (UNAUDITED)        
Cathay United Bank   $ -     $ 253,036  
CTBC Bank     656,000       674,764  
Total   $ 656,000     $ 927,800  

 

Cathay United Bank

 

On June 28, 2016, BioLite Taiwan and Cathay United Bank entered into a one-year bank loan agreement (the “Cathay United Loan Agreement”) in an amount of NT$7,500,000, equivalent to $246,000. The term started June 28, 2016 with maturity date at June 28, 2017. The loan balance bore interest at a floating rate of prime rate plus 1.15%. The prime rate is based on term deposit saving interest rate of Cathay United Bank. On September 6, 2017, BioLite Taiwan extended the Cathay United Loan Agreement for one more year through September 6, 2018 with the principal amount of NT$7,500,000, equivalent to $246,000. As of September 30, 2018 and December 31, 2017, the effective interest rates per annum were 2.22%. The loan is collateralized by the building and improvement of BioLite Taiwan, and is also personal guaranteed by the Company’s chairman. The Company repaid the principal and interests of this bank loan on September 6, 2018.

 

Interest expenses were $1,361 and $12 for the three months ended September 30, 2018 and 2017, respectively. Interest expenses were $4,175 and $2,723 for the nine months ended September 30, 2018 and 2017, respectively.

 

CTBC Bank

 

On June 12, 2017 and July 19, 2017, BioLite Taiwan and CTBC Bank entered into short-term saving secured bank loan agreements (the “CTBC Loan Agreements”) in an amount of NT$10,000,000, equivalent to $328,000, and NT$10,000,000, equivalent to $328,000, respectively. Both two loans had the same maturity date at January 19, 2018. In February 2018, BioLite Taiwan combined two loans and extended the loan contract with CTBC for one year. The extended maturity date is January 19, 2019.The loan balances bear interest at a fixed rate of 1.63% per annum. The loan is guaranteed by the Company’s chairman and BioFirst.

 

Interest expenses were $2,768 and $2,214 for the three months ended September 30, 2018 and 2017, respectively. Interest expenses were $8,270 and $2,214 for the nine months ended September 30, 2018 and 2017, respectively.

 

22

 

 

(2) Long-term bank loan consists of the following:

 

    September 30,     December 31,  
    2018     2017  
    (UNAUDITED)        
Cathay United Bank   $ 64,829     $ 95,893  
Less: current portion of long-term bank loan     (39,737 )     (40,203 )
Total   $ 25,092     $ 55,690  

 

On April 30, 2010, BioLite Taiwan entered into a seven-year bank loan of NT$8,900,000, equivalent to $291,920, with Cathay United Bank. The term started April 30, 2010 with maturity date at April 30, 2017. On April 30, 2017, BioLite Taiwan extended the original loan agreement for additional three years with the new maturity date at April 30, 2020. The loan balance bears interest at a floating rate of prime rate plus variable rates from 0.77% to 1.17%. The prime rate is based on term deposit saving interest rate of Cathay United Bank. As of September 30, 2018 and December 31, 2017, the actual interest rates per annum were 2.24%. The loan is collateralized by the building and improvement of BioLite Taiwan, and is also personal guaranteed by the Company’s chairman.

 

Interest expenses were $122 and $603 for the three months ended September 30, 2018 and 2017, respectively. Interest expenses were $1,375 and $1,932 for the nine months ended September 30, 2018 and 2017, respectively.

 

NOTE 8. NOTES PAYABLE

 

On November 27, 2017, BioLite Taiwan and Cheng-Chi International Co., Ltd., a Taiwanese company, entered into a promissory note, (the “Cheng-Chi Promissory Note”), for borrowing an aggregate amount of NT$6,000,000, equivalent to $196,800, for the period from November 27, 2017 to January 11, 2018. The principal of the Cheng-Chi Promissory Note bore interest at 12% per annum. This Cheng-Chi Promissory Note was secured by 700,000 common stock shares of ABVC and was also personal guaranteed by the Company’s chairman. On January 11, 2018, the principal and accrued interest totaling NT$6,090,000, equivalent to $199,752, has been paid in full.

 

On March 27, 2018, BioLite Taiwan and two individuals entered into a promissory note, (the “Hsu and Chow Promissory Note”), for borrowing an aggregate amount of NT$4,660,000, equivalent to $152,848, for the period from March 27, 2018 to June 26, 2018. On September 26, 2018, the company extended the original loan agreement through December 26, 2018. The principal of the Hsu and Chow Promissory Note bore interest at 13.6224% per annum. This Hsu and Chow Promissory Note was secured by common stock shares of ABVC and was also personal guaranteed by the Company’s chairman. Interest expense was $4,581 and $11,106 for the three and nine months ended September 30, 2018, respectively.

 

During the nine months ended September 30, 2018, BioLite Taiwan also entered various unsecured loan agreements bearing interest at fixed rates between 12% and 13.6224% per annum with three individuals to advance in aggregate of NT$10,500,000, equivalent to $344,400, for working capital purpose. The term of the loan varies from one month to three months with various maturity dates through May 25, 2018. As of the date of this report, the Company is still in discussion with the three individuals with respect to the terms of extension for the unsecured loans. Interest expense was $14,422 and $33,500 for the three and nine months ended September 30, 2018, respectively.

 

NOTE 9. ACCRUED EXPENSES

 

Accrued expenses mainly consist of the following:

 

   

September 30,

2018

    December 31, 2017  
    (UNAUDITED)        
Accrued salaries and bonus   $ 154,073     $ 45,862  
Accrued employee benefits and pension expenses     6,919       9,390  
Accrued professional service fees     32,128       8,300  
Accrued research and development expenses     38,116       2,656  
Accrued collaboration revenue payable     389,460       400,600  
Others     19,023       44,404  
    $ 639,719     $ 511,212  

 

23

 

 

NOTE 10. OTHER PAYABLE

 

Other payable mainly consists of the following:

 

   

September 30,

2018

    December 31, 2017  
    (UNAUDITED)        
Other payable   $ 11,801     $ 4,532  
Taiwan income tax withholding payable     50,660       11,756  
Litigation payable (a)     7,437       -  
Temporary receipts     75,440       -  
    $ 145,338     $ 16,288  

 

(a) Contingencies and legal proceedings

 

In January 2018, a former employee of the Company, (the “Plaintiff”), filed a class action civil complaint against the Company at Taiwan Hsin-Chu District Court. The Plaintiff alleged the following causes of action under the Labor Standards Act of Taiwan: (1) failure to pay employees for all hours worked; (2) failure to pay accrued vacation wages; (3) failure to pay severance payments; and (4) failure to distribute retirement pension to pension trust. The case went to trial on July 12, 2018, and on July 31, 2018, the court pronounced its judgment that the Company is obligated to pay the compensation amount of NT$226,738, equivalent $7,437 to the Plaintiff. An appeal was filed by the Company in August 2018. The next court session is scheduled in December 2018. As of September 30, 2018, the Company has recorded the full liability of $7,437 pursuant to ASC 450-20-25-2 under Topic 450, “Contingencies Loss Contingencies Recognition”.

 

NOTE 11. SHARE-BASED COMPENSATION

 

On November 15, 2013, the Board of Directors of BioLite Taiwan approved the adoption of the 2013 Stock Option and Incentive Plan, (the “2013 Plan”), providing for the issuance under 2013 Plan of options and rights to purchase up to two million seventy thousand (2,070,000) shares of common stock. Awards of incentive options may be granted under the 2013 Plan until December 31, 2017. As of September 30, 2018 and December 31, 2017, there were 0 and 487,000 shares available for issuance under the 2013 Plan, respectively, which provides for the grant of share-based awards to employees and officers.

 

Plan Administration ─ The 2013 Plan may be administered by the full Board of Directors of BioLite Taiwan. The Board of BioLite Taiwan has full power to select, from among the individuals eligible for awards, the individuals to whom awards will be granted, to make any combination of awards to participants, and to determine the specific terms and conditions of each award, subject to the provisions of the 2013 Plan.

 

Eligibility Persons eligible to participate in 2013 Plan will be those full time employees and officers of the Company as selected from time to time by the Board of BioLite Taiwan in its discretion.

 

Limits ─ Under 2013 Plans, stock options granted to any individual employee cannot exceed 25% of the Plan, neither to exceed 3% of the total common stock shares issued by BioLite Taiwan.

 

24

 

 

Stock Options ─ The option exercise price of each option under both plans was determined by the Company's status at the date of grant: (i) before public offering date: the option exercise price would be NT$12.5, equivalent to $0.39, per share and NT$15.0, equivalent to $0.46, per share for the 2013 Plan, respectively, (ii) after public offering date: the exercise price would be decided by the Board of BioLite Taiwan, and not less than the book value per share on the latest financial report before the date of grant, (iii) after been listed on the secondary market, the option exercise price would be the market price, but not less than the par value of the common stock. The exercise price of an option may not be reduced after the date of the option grant, other than to appropriately reflect changes in its capital structure. The term of the option was determined by the Board of Directors of BioLite Taiwan, under the 2013 Plan, employees could exercise 50%, 75%, and 100% of the options at 6 months, 12 months and 24 months after the date of grant. In general, unless otherwise permitted by the Board of BioLite Taiwan, no option granted under 2013 Plan are transferable by the optionee other than by will or by the laws of descent and distribution, and options may be exercised during the optionee’s lifetime only by the optionee, or by the optionee’s legal representative or guardian in the case of the optionee’s incapacity.

 

Under 2013 Plan, upon exercise of options, the option exercise price must be paid in full either in cash, by certified or bank check, or other instrument acceptable to the Board BioLite Taiwan. Subject to applicable law, the exercise price may also be delivered to BioLite Taiwan by a broker pursuant to irrevocable instructions to the broker from the optionee. To qualify as incentive options, options must meet additional tax requirements.

 

Tax Withholding ─ Participants in the 2013 Plan are responsible for the payment of any taxes that BioLite Taiwan is required by law to withhold upon the exercise of options or vesting of other awards. Subject to approval by the Board, participants may elect to have the minimum tax withholding obligations satisfied by authorizing BioLite Taiwan to withhold shares of common stock to be issued pursuant to the exercise or vesting.

 

Amendments and Termination ─ The Board of Directors of BioLite Taiwan may at any time amend or discontinue the 2013 Plan, and the Board of BioLite Taiwan may at any time amend or cancel any outstanding award for the purpose of satisfying changes in the law or for any other lawful purpose. However, no such action may adversely affect any rights under any outstanding award without the holder’s consent. Any amendments that materially change the terms of 2013 Plan will be subject to approval by the administrative authorities.

 

The following table summarizes the stock option activity under the 2013 Plan, and related information:

 

Options Outstanding  
    Number of         Weighted-        
    Shares     Weighted     Average        
    Underlying     Average     Remaining     Aggregate  
    Outstanding     Exercise     Contractual     Intrinsic  
    Options     Price     Life (Years)     Value  
Outstanding – January 1, 2016     487,000     $ 0.4600       2.13     $         -  
Granted     -     -       -       -  
Exercised     -       -       -       -  
Forfeited or cancelled     -       -       -       -  
Outstanding – December 31, 2016     487,000     $ 0.4600       2.13     $ -  
Granted     -       -       -       -  
Exercised     -       -       -       -  
Forfeited or cancelled     -       -       -       -  
Outstanding – December 31, 2017     487,000     $ 0.4600       2.13     $ -  
Granted     -       -       -       -  
Exercised     -       -       -       -  
Forfeited or cancelled     (487,000 )     -       -       -  
Outstanding – September 30, 2018     -     $ -       -     $ -  
                                 
Exercisable – September 30, 2018     -     $ -       -     $ -  
                                 
Vested and expected to vest – September 30, 2018     -     $ -       -     $ -  
                                 
Exercisable – December 31, 2017     487,000     $ 0.4600       2.13     $ -  
                                 
Vested and expected to vest – December 31, 2017     487,000     $ 0.4600       2.13     $ -  

 

Compensation expense related to share-based transactions is measured and recognized in general and administrative expenses in the financial statements based on the fair value of the awards granted. The share-based compensation expense, net of forfeitures, is recognized on a straight-line basis over the requisite service periods of the awards, which is generally a half year to two years. The Company recognized stock-based compensation expense of $0 and $0 for the three and nine months ended September 30, 2018 and 2017, respectively.

 

25

 

 

NOTE 12. RELATED-PARTY TRANSACTION

 

Related parties:

 

(1) Lion Arts Promotion Inc. (hereinafter, “LION”) was incorporated on March 17, 1997 under the laws of Taiwan. LION is in the business of art related promotion and is a controlling shareholder of BioLite Taiwan.

 

(2) BioFirst Corporation (hereinafter, “BioFirst”) was incorporated on November 7, 2006 under the laws of Taiwan. BioFirst is in the business of researching, developing, manufacturing, and marketing of innovative patented medical products. As of September 30, 2018 and December 31, 2017, the Company owned 21.51% and 21.51% common stock shares of BioFirst (See NOTE 5), respectively.

 

(3) American BriVision Corporation (hereinafter, “BriVision”) was incorporated on July 21, 2015 in the State of Delaware, engaging in biotechnology and focuses on the development of new drugs and innovative medical devices to fulfill unmet medical needs. In 2015, BriVision entered a collaborative agreement with the Company (See NOTE 3). On May 6, 2016, the Company and BriVision entered into an addendum to the collaborative agreement, whereby BriVision has agreed to pay the upfront payment to the Company $2,600,000 in cash and $900,000 in newly issued shares of common stock of BriVision’s holding company, American BriVision (Holding) Corporation (“ABVC”), a Nevada company, at the price of $1.60 per share, for an aggregate number of 562,500 shares. In August 2016, the Company made additional equity investment of $2,350,000 in cash to acquire 1,468,750 shares of common stock of ABVC. In February 2017, the Company received $650,000 in cash and $5,850,000 in the form of newly issued 2,925,000 shares of common stock of ABVC, at the price of $2.0 per share for the first milestone payment. As of September 30, 2018 and December 31, 2017, the Company owned 2.32% common stock of ABVC (See NOTE 5).

 

(4) Rgene Corporation (hereinafter, “Rgene”) was incorporated on June 24, 2010 under the laws of Taiwan. Rgene is in the business of research and development and innovation of various drugs. On March 23, 2017, the Company acquired 600,000 shares of common stock of Rgene for NT$15,000,000, equivalent approximately $493,500, in cash. As of September 30, 2018 and December 31, 2017, the Company owned 13.04% common stock of Rgene (See NOTE 5).

 

(5) AsianGene Corporation (hereinafter, “AsianGene”) was incorporated on December 16, 2013 under the laws of Taiwan. AsianGene is in the business of real estate development. AsianGene is one of the shareholders of the Company.

 

(6) LionGene Corporation (hereinafter, “LionGene”) was incorporated on November 23, 2009 under the laws of Taiwan. LionGene is in the business of biotechnology services. LionGene and the Company are related parties and under common control by a controlling beneficiary shareholder of the Company.

 

26

 

 

(7) Mr. Tsung-Shann Jiang is the chairman and CEO of the Company and the President and a member of board of directors of BioFirst. Mr. Jiang is also the controlling beneficiary shareholder of ABVC, BriVision, and Rgene. Ms. Shu-Ling Jiang, Mr. Tsung-Shann Jiang’s wife, is the chairman of LION and BioFirst, and a member of board of directors of the Company. Mr. Eugene Jiang is Mr. and Ms. Jiang’s son. Mr. Eugene Jiang is a member of board of directors of the Company, and is also the chairman, interim CFO, and majority shareholder of ABVC. Mr. Tsung-Shann Jiang, Ms. Shu-Ling Jiang, and Mr. Eugene Jiang hereinafter are collectively called “JIANGS”.

 

Related party transactions:

 

For the nine months ended and as of September 30, 2018, the related party transactions are summarized as follows:

 

    Amounts     Amounts     Accounts     Loan to     Rent  
    due from     due to     receivable     (Loan from)     Expenses (a)  
LION   $ -     $ 65,689     $ 656     $ -     $ 9,553  
BioFirst     -       372,812       -       (1,899,807 )     -  
ABVC & BriVision     22,009       -       -       -       -  
Rgene     45,320       -       -       -       -  
LionGene     62,238       -       -       -       -  
JIANGS     -       328,474       -       (90,282 )     -  
Total   $ 129,567     $ 766,975     $ 656     $ (1,990,089 )   $ 9,553  

 

As of December 31, 2017, the balances due to and due from related parties are summarized as follows:

 

    Amounts     Amounts     Accounts     Loan to  
    due from     due to     receivable     (Loan from)  
LION   $ -     $ 23,171     $ 1,350     $ -  
BioFirst     -       1,118,361       2,125       (937,922 )
ABVC & BriVision     115,168       -       -       -  
Rgene     3,316       -       -       33,738  
AsianGene     1,731       -       -       -  
JIANGS     -       311,044       -       -  
Total   $ 120,215     $ 1,452,576     $ 3,475     $ (904,184 )

 

For the nine months ended September 30, 2017, the related party transactions are summarized as follows:

 

    Merchandise Sales     Rent
Expenses (a)
 
LION   $ 1,624     $ 28,103  
Total   $ 1,624     $ 28,103  

 

(a) The Company leased its office from LION. The monthly base rent was approximately $3,000. The lease was terminated on March 31, 2018. Rent expense under this lease agreement amounted to $9,553 and $28,103 for the nine months ended September 30, 2018 and 2017, respectively.

 

27

 

 

NOTE 13. INCOME TAX

 

U.S.A

 

BioLite Holding, Inc. files income tax returns in the U.S. federal jurisdiction, and state and local jurisdictions.

 

On December 22, 2017   H.R. 1 ,  originally known as the Tax Cuts and Jobs Act, (the “Tax Act”) was enacted. Among the significant changes to the U.S. Internal Revenue Code, the Tax Act lowers the U.S. federal corporate income tax rate (“Federal Tax Rate”) from 35% to 21% effective January 1, 2018 The 21% Federal Tax Rate will apply to earnings reported for the full 2018 fiscal year. In addition, the Company must re-measure its net deferred tax assets and liabilities using the Federal Tax Rate that will apply when these amounts are expected to reverse. As of September 30, 2018 and December 31, 2017, the Company can determine a reasonable estimate for certain effects of tax reform and is recording that estimate as a provisional amount. The provisional remeasurement of the deferred tax assets and allowance valuation of deferred tax assets at September 30, 2018 and December 31, 2017 resulted in a net effect of $0 discrete tax expenses (benefit) which lowered the effective tax rate by 14% for the year ended December 31, 2017. The provisional remeasurement amount is anticipated to change as data becomes available allowing more accurate scheduling of the deferred tax assets and liabilities primarily related to net operating loss carryover.

 

British Virgin Islands

 

BioLite BVI, Inc. was incorporated in British Virgin Islands, which does not tax income.

 

Taiwan

 

BioLite Inc. was incorporated in Taiwan. According to the amendments to the “Income Tax Act” enacted by the office of the President of the Republic of China on February 7, 2018, an increase in the statutory income tax rate from 17% to 20% and decrease in the undistributed earning tax from 10% to 5% are effective from January 1, 2018. This increase in the statutory income tax rate does not affect the amounts of the current taxes recognized as of December 31, 2017 and for the year then ended. No income tax liabilities existed as of September 30, 2018 and December 31, 2017 due to the Company's continuing operating losses. As of September 30, 2018 and December 31, 2017, the Company had deferred tax assets related to tax loss and credit carryforwards totaling $1,227,334 and $1,017,897, respectively, which begin to expire in 2026.

 

Provision for income tax (benefit) consists of the following:

 

    For the Three Months Ended     For the Nine Months Ended  
    September 30,     September 30,  
    2018     2017     2018     2017  
Current provision                                
U.S.A.   $ -     $ -     $ -     $ -  
Taiwan     -       -       -       -  
Subtotal   $ -     $ -     $ -     $ -  
Deferred provision                                
U.S.A.   $ -     $ -     $ -     $ -  
Taiwan     (69,075 )     (64,900 )     (242,092 )     (224,762 )
Total provision for income tax(benefit)   $ (69,075 )   $ (64,900 )   $ (242,092 )   $ (224,762 )

 

28

 

 

The components of deferred tax assets consisted of the following:

 

   

September 30,

2018

    December 31, 2017  
      (UNAUDITED)          
Deferred tax assets:                
U.S.A                
Tax loss and credit carryforwards   $ 155,612     $ 155,612  
Less: Valuation allowance     (155,612 )     (155,612 )
Subtotal     -       -  
Taiwan                
Loss on disposal of assets   $ 676,105     $ 694,810  
Tax loss and credit carryforwards     1,227,334       1,017,897  
Less: Valuation allowance     (676,105 )     (694,810 )
Subtotal     1,227,334       1,017,897  
Total deferred tax assets   $ 1,227,334     $ 1,017,897  

 

The difference between the combined effective income tax rate reflected in the provision for income tax on income (loss) before taxes and the amounts determined by applying the applicable the U.S. statutory income tax rate and Taiwan unified income tax rate for the nine months ended September 30, 2018 and 2017 are analyzed below:      

 

   

For the Nine Months Ended

September 30,

 
    2018     2017  
    (UNAUDITED)  
U.S. statutory income tax rate     21 %     35 %
Taiwan unified income tax rate     20 %     17 %
Changes in valuation allowance     (56 )%     (55 )%
Effective combined income tax rate     (15 )%     (3 )%

 

29

 

 

NOTE 14. COMMITMENTS

 

Operating lease commitment:

 

The Company’s operating leases include lease contracts of office spaces, laboratory space, and employees’ dormitory. Future minimum lease payments under the operating leases are summarized as follows:

 

As of September 30,   Amount  
2019   $ 57,684  
2020     12,546  
Total   $ 70,230  

 

In-Licensing collaborative agreement commitment:

 

(1) On January 1, 2011, BioLite Taiwan entered into a collaborative agreement (the “PITDC Collaborative Agreement”) with Medical and Pharmaceutical Industry Technology and Development Center (“PITDC”), a Taiwanese Company. Pursuant to the PITDC Collaborative Agreement, PITDC granted BioLite Taiwan the sole licensing right for drug and therapeutic use of depressive disorders related patent and technology expired in November 2026. The total consideration for obtaining such grant was NT$17,000,000, equivalent approximately $557,600, of which NT$3,400,000, equivalent approximately $111,520, was due within 30 days upon signing the agreement and the remaining balance of NT$13,600,000, equivalent approximately $446,080, is due pursuant to a milestone payment schedule. In addition, BioLite Taiwan is required to pay PITDC 10% of sublicensing revenues net of related research and development cost and royalties at a range from 1% to 3% of sales of drugs.

 

BioLite Taiwan paid the upfront payment of NT$3,400,000, equivalent approximately $111,520, in 2011, the first milestone payment of NT$2,550,000, equivalent approximately $83,640, in 2012, and the third milestone payment of NT$2,125,000, equivalent approximately $69,700, in 2013. BioLite Taiwan recorded these amounts as research and development expenses when incurred.

 

Pursuant to the PITDC Collaborative Agreement, BioLite Taiwan is also required to pay PITDC 10% of sublicensing revenues to PITDC. During the nine months ended September 30, 2018 and 2017, BioLite Taiwan paid $0 to PITDC accounting for 10% of sublicensing revenues net of related research and development cost and royalties. As of September 30, 2018 and December 31, 2017, BioLite Taiwan has accrued collaboration revenue payable of $274,866 and $282,728 to PITDC, respectively.

 

(2) On February 10, 2011, BioLite Taiwan entered into a collaborative agreement (the “ITRI Collaborative Agreement I”) with Industrial Technology Research Institute (“ITRI”), a Taiwanese Company. Pursuant to the ITRI Collaborative Agreement I, ITRI granted BioLite Taiwan the sole licensing right for drug and therapeutic use of colon inflammation related patent and technology expired in February 2031. The total consideration for obtaining such grant was NT$20,000,000, equivalent approximately $656,000, of which NT$2,000,000, equivalent approximately $65,600, was due sixth days upon signing the agreement and the remaining balance of NT$18,000,000, equivalent approximately $590,400, was due pursuant to a milestone payment schedule. BioLite Taiwan paid the upfront payment of NT$2,000,000, equivalent approximately$65,600, in 2011 and the first milestone payment of NT$2,000,000, equivalent approximately $65,600, in 2016. BioLite Taiwan recorded these amounts as research and development expenses when incurred.

 

Pursuant to the ITRI Collaborative Agreement I, BioLite Taiwan is also required to pay ITRI 10% of sublicensing revenues net of related research and development cost and royalties at a range from 3% to 5% of sales of drugs. During the nine months ended September 30, 2018 and 2017, BioLite Taiwan paid $0 to ITRI accounting for 10% of sublicensing revenues net of related research and development cost and royalties. As of September 30, 2018 and December 31, 2017, BioLite Taiwan has accrued collaboration revenue payable of $114,594 and $117,872 to ITRI, respectively.

 

(3) On February 10, 2011, BioLite Taiwan entered into another collaborative agreement (the “ITRI Collaborative Agreement II”) with Industrial Technology Research Institute (“ITRI”), a Taiwanese Company. Pursuant to the ITRI Collaborative Agreement II, ITRI granted BioLite Taiwan the sole licensing right for drug and therapeutic use of rheumatoid arthritis related patent and technology expired in February 2031. The total consideration for obtaining such grant was NT$35,000,000, equivalent approximately $1,148,000, of which NT$3,500,000, equivalent approximately $114,800, was due sixth days upon signing the agreement and the remaining balance of NT$31,500,000, equivalent approximately $1,033,200, was due pursuant to a milestone payment schedule. BioLite Taiwan paid the upfront payment of NT$3,500,000, equivalent approximately $114,800, in 2011. BioLite Taiwan recorded these amounts as research and development expenses when incurred.

 

30

 

 

Pursuant to the ITRI Collaborative Agreement II, BioLite Taiwan is also required to pay ITRI 10% of sublicensing revenues net of related research and development cost and royalties at a range from 3% to 5% of sales of drugs. As of September 30, 2018 and December 31, 2017, BioLite Taiwan has not sublicensed the licensing right for drug and therapeutic use of rheumatoid arthritis related patent and technology to any companies.

 

(4) On December 27, 2016, BioLite Taiwan entered into a collaborative agreement (the “Yukiguni Collaborative Agreement”) with Yukiguni Maitake Co., Ltd (“YUKIGUNI”), a Japanese company. Pursuant to the Yukiguni Collaborative Agreement , YUKIGUNI granted BioLite Taiwan the right for selling Maitake dry powder and Maitake extract manufactured by YUKIGUNI, and the right for using Maitake related patent and technology expired in December 2036 or fifteen years after the date when the new product developed by BioLite Taiwan is first sold, whichever is earlier. The total consideration for obtaining such grant would be $305,000. During the nine months ended September 30, 2018 and 2017, BioLite Taiwan has paid YUKIGUNI an aggregate of $175,000 and $0, respectively, to obtain some Maitake related patent and technology.

 

NOTE 15. SUBSEQUENT EVENT

 

The Company has evaluated subsequent events through the date which the financial statements were available to be issued. All subsequent events requiring recognition as of September 30, 2018 have been incorporated into these financial statements and there are no subsequent events that require disclosure in accordance with FASB ASC Topic 855, “Subsequent Events.”

 

******

  

31

Exhibit 99.3

 

 

 

 

 

 

 

 

 

Biokey, Inc.

 

FINANCIAL STATEMENTS FOR THE YEARS ENDED

DECEMBER 31, 2017 and 2016

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

  

 

A udit  ● T ax  ● C onsulting  ●  F inancial  A dvisory  

 

Registered with Public Company Accounting Oversight Board (PCAOB)

 

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

 

 To the Board of Directors and Shareholders of Biokey, Inc.

 

Opinion on the Financial Statements

 

We have audited the accompanying balance sheets of Biokey, Inc. ( “the Company”) as of December 31, 2017 and 2016, the related statement of operations and comprehensive income(loss), stockholders’ equity, and cash flows for the years then ended, and the related notes (collectively referred to as the “financial statements”) . In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2017 and 2016, and the results of its operations and its cash flows for the years ended December 31, 2017 and 2016, in conformity with the U.S. generally accepted accounting principles.

 

Basis for Opinion

 

These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

 

We conducted our audits in accordance with the standards of the PCAOB.  Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement , whether due to error or fraud.   Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.

 

/s/ KCCW Accountancy Corp.  

  

We have served as the Company’s auditor since 2018.

Diamond Bar, California

April 27, 2018

  

  KCCW Accountancy Corp.
  3333 S Brea Canyon Rd. #206, Diamond Bar, CA 91765, USA
  Tel: +1 909 348 7228 ● Fax: +1 909 895 4155 ● info@kccwcpa.com

   

2

 

 

BIOKEY, INC.

BALANCE SHEETS

 

    December 31,     December 31,  
    2017     2016  
ASSETS            
Current Assets            
Cash and cash equivalents   $ 1,225,397     $ 1,473,262  
Accounts Receivable, net     59,080       74,777  
Accounts Receivable - related parties, net     134,312       175,900  
Other receivable     -       6,000  
Total Current Assets     1,418,789       1,729,939  
                 
Property and equipment, net     37,600       41,186  
Security Deposits     10,440       10,440  
Total Assets   $ 1,466,829     $ 1,781,565  
                 
LIABILITIES AND EQUITY                
Current Liabilities                
Accounts payable   $ 5,396     $ 24,485  
Due to shareholders     5,800       5,800  
Accrued expenses and other current liabilities     57,576       55,612  
Advance from customers     10,985       15,452  
Total Current Liabilities     79,757       101,349  
                 
Non-current Liabilities                
Tenant security deposit     2,880       2,880  
Total Liabilities     82,637       104,229  
                 
Equity                
Preferred stock, no par value, 23,562,000 shares authorized:                
7,000,000 shares of Series A issued and outstanding at December 31, 2017 and 2016     3,500,000       3,500,000  
1,160,000 shares of Series B issued and outstanding at December 31, 2017 and 2016     1,160,000       1,160,000  
13,973,097 shares of Series C issued and outstanding at December 31, 2017 and 2016     13,973,097       13,973,097  
Common stock, no par value; 30,000,000 shares authorized, 6,498,134 shares issued and outstanding at December 31, 2017 and 2016     541,793       541,793  
Additional paid-in capital - stock options     296,465       296,465  
Accumulated deficit     (18,087,163 )     (17,794,019 )
Total Equity     1,384,192       1,677,336  
                 
Total Liabilities and Equity   $ 1,466,829     $ 1,781,565  

  

3

 

  

BIOKEY, INC.

STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)

FOR THE YEARS ENDED DECEMBER 31, 2017 AND 2016

 

    2017     2016  
             
Revenues   $ 983,218     $ 1,555,594  
Cost of revenues     17,312       29,420  
Gross profit     965,906       1,526,174  
                 
Operating expenses:                
Research and development expenses     497,947       486,004  
Selling, general and administrative expenses     767,504       918,271  
Total operating expenses     1,265,451       1,404,275  
                 
Income (loss) from operations     (299,545 )     121,899  
                 
Other income (expense)                
Interest income     6,742       7,385  
Other income (expenses)     459       1,407  
Total other income (expenses)     7,201       8,792  
Income (loss) before income tax     (292,344 )     130,691  
Provision for income tax     800       800  
Net income (loss) and comprehensive income (loss)   $ (293,144 )   $ 129,891  

  

4

 

  

BIOKEY, INC.

STATEMENTS OF EQUITY

FOR THE YEARS ENDED DECEMBER 31, 2017 AND 2016

 

    Preferred Stock     Common Stocks     Additional
Paid-in
    Accumulated        
    Shares     Amounts     Shares     Amounts     Capital     Deficit     Total  
                                           
Balance at December 31, 2015     22,133,097     $ 18,633,097       6,498,134     $ 541,793     $ 296,465     $ (17,923,910 )   $ 1,547,445  
Net income     -       -       -       -       -       129,891       129,891  
Balance at December 31, 2016     22,133,097     $ 18,633,097       6,498,134     $ 541,793     $ 296,465     $ (17,794,019 )   $ 1,677,336  
Net loss     -       -       -       -       -       (293,144 )     (293,144 )
Balance at December 31, 2017     22,133,097     $ 18,633,097       6,498,134     $ 541,793     $ 296,465     $ (18,087,163 )   $ 1,384,192  

  

5

 

 

BIOKEY, INC.

STATEMENTS OF CASH FLOWS

FOR THE YEARS ENDED DECEMBER 31, 2017 AND 2016

 

    2017     2016  
Cash flows from operating activities            
Net income (loss)   $ (293,144 )   $ 129,891  
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:                
Depreciation and amortization     11,380       9,314  
Changes in assets and liabilities:                
Decrease (increase) in accounts receivable     57,285       43,708  
Decrease (increase) in other receivable     6,000       (6,000 )
Decrease (increase) in prepaid expenses and other deposits     -       3,323  
Increase (decrease) in accounts payable     (19,089 )     (61,620 )
Increase (decrease) in accrued  expenses and other current liabilities     1,964       (14,087 )
Increase (decrease) in advanced from others     (4,467 )     3,642  
Net cash provided by (used in) operating activities     (240,071 )     108,171  
                 
Cash flows from investing activities                
Purchase of equipment     (7,794 )     (39,911 )
Net cash used in investing activities     (7,794 )     (39,911 )
                 
Net increase (decrease) in cash and cash equivalents     (247,865 )     68,260  
                 
Cash and cash equivalents                
Beginning     1,473,262       1,405,002  
Ending   $ 1,225,397     $ 1,473,262  
                 
Supplemental disclosure of cash flows                
Cash paid during the year for:                
Income tax   $ 800     $ 800  
Interest expense   $ -     $ -  

  

6

 

 

BIOKEY, INC.

NOTES TO THE FINAICAL STATEMENTS  

DECEMBER 31, 2017 AND 2016

 

NOTE 1. Nature of Business and Significant Accounting Policies

  

Nature of business: Biokey, Inc., (hereinafter, “the Company”), was incorporated on August 9, 2000 in the State of California. It is engaged primarily in research and development, manufacturing, and distribution of generic drugs and nutraceuticals with strategic partners. The Company provides a wide range of services, including, API characterization, pre-formulation studies, formulation development, analytical method development, stability studies, IND/NDA/ANDA/510K submissions, and manufacturing clinical trial materials (phase 1 through phase 3) and commercial manufacturing. The Company also licenses out its technologies and initiates joint research and development processes with other biotechnology, pharmaceutical, and nutraceutical companies.

  

A summary of the Company’s significant accounting policies is as follows:

 

Basis of presentation: The accompanying financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America.

  

Use of estimates: The preparation of financial statements in conformity with generally accepted accounting principles of United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.

 

Cash and cash equivalents: For purposes of reporting cash flows, the Company considers all highly liquid debt instruments purchased with a maturity of three months or less to be cash equivalents.

  

Accounts receivable and other receivable: Accounts receivable and other receivable are stated at carrying value less estimates made for doubtful receivables. An allowance for impairment of trade receivable and other receivable is established if the collection of a receivable becomes doubtful. Such receivable becomes doubtful when there is objective evidence that the Company will not be able to collect all amounts due according to the original terms of the receivables. Significant financial difficulties of the debtor, probability that the debtor will enter into bankruptcy or financial reorganization, and default or delinquency in payments are considered indicators that the receivable is impaired. The amount of the allowance is the difference between the asset’s carrying amount and the present value of estimated future cash flows, discounted at the original effective interest rate.

  

Property and equipment: Property and equipment are recorded at cost. Depreciation is computed on the straight-line method over the estimated useful lives of the related assets as follows:

  

Laboratory and manufacturing equipment 2 ~5 years
Office equipment 3 years
Leasehold improvement 3 ~8 years
Furniture and fixtures 8~15 years

  

7

 

 

Expenditures for major renewals and betterment that extend the useful lives of property and equipment are capitalized. Expenditures for repairs and maintenance are charged to expense as incurred. When property and equipment are retired or otherwise disposed of, the asset and accumulated depreciation are removed from the accounts and the resulting profit or loss is reflected in the statement of income for the period.

 

Impairment of long-lived assets: The Company reviews its long-lived assets whenever events or circumstances indicate that the carrying amount of such assets may not be recoverable. Impairment is evaluated by comparing the carrying value of the long-lived assets with the estimated future net undiscounted cash flows expected to result from the use of the assets, including cash flows from disposition. Should the sum of the expected future net cash flows be less than the carrying value, the Company would recognize an impairment loss at that date. An impairment loss would be measured by comparing the amount by which the carrying value exceeds the fair value (estimated discounted future cash flows) of the long-lived assets.

  

Revenue recognition: The Company’s revenue recognition policy is in accordance with U.S. GAAP when the following overall fundamental criteria are met: (i) persuasive evidence of an arrangement exists, (ii) delivery has occurred or the service has been performed, (iii) the Company’s price to the customer is fixed or determinable and (iv) collection of the resulting accounts receivable is reasonably assured.

  

Advertising costs: Advertising costs are expensed as incurred. The total advertising and marketing expenses were $0 for the years ended December 31, 2017 and 2016.

 

Research and development: The Company accounts for R&D costs in accordance with Accounting Standards Codification (“ASC”) 730, Research and Development (“ASC 730”). Research and development expenses are charged to expense as incurred unless there is an alternative future use in other research and development projects or otherwise. Research and development expenses are comprised of costs incurred in performing research and development activities, including personnel-related costs, facilities-related overhead, and outside contracted services including clinical trial costs, manufacturing and process development costs for both clinical and preclinical materials, research costs, and other consulting services. Non-refundable advance payment for goods and services that will be used in future research and development activities are expensed when the activity has been performed or when the goods have been received rather than when the payment is made. In instances where the Company enters into agreements with third parties to provide research and development services, costs are expensed as services are performed.

  

Income taxes: The Company accounts for income taxes in accordance with ASC 740, Income Taxes, which requires that the Company recognize deferred tax liabilities and assets based on the differences between the financial statement carrying amounts and the tax basis of assets and liabilities, using enacted tax rates in effect in the years the differences are expected to reverse. Deferred income tax benefit (expense) results from the change in net deferred tax assets or deferred tax liabilities. A valuation allowance is recorded when, in the opinion of management, it is more likely than not that some or all of any deferred tax assets will not be realized. The Company provides criteria for the recognition, measurement, presentation and disclosure of uncertain tax position.

  

Valuation of deferred tax assets: A valuation allowance is recorded to reduce its deferred tax assets to the amount that is more likely than not to be realized. In assessing the need for the valuation allowance, management considers, among other things, projections of future taxable income and ongoing prudent and feasible tax planning strategies. If the Company determines that sufficient negative evidence exists, then it will consider recording a valuation allowance against a portion or all of the deferred tax assets in that jurisdiction. If, after recording a valuation allowance, the Company’s projections of future taxable income and other positive evidence considered in evaluating the need for a valuation allowance prove, with the benefit of hindsight, to be inaccurate, it could prove to be more difficult to support the realization of its deferred tax assets. As a result, an additional valuation allowance could be required, which would have an adverse impact on its effective income tax rate and results. Conversely, if, after recording a valuation allowance, the Company determines that sufficient positive evidence exists in the jurisdiction in which the valuation allowance was recorded, it may reverse a portion or all of the valuation allowance in that jurisdiction. In such situations, the adjustment made to the deferred tax asset would have a favorable impact on its effective income tax rate and results in the period such determination was made. See Note 8 for information related to income taxes, including the recorded balances of its valuation allowance related to deferred tax assets.

  

8

 

 

The Company applied the provisions of ASC 740-10-50, “Accounting For Uncertainty In Income Taxes”, which provides clarification related to the process associated with accounting for uncertain tax positions recognized in its financial statements. Audit periods remain open for review until the statute of limitations has passed. The completion of review or the expiration of the statute of limitations for a given audit period could result in an adjustment to the Company’s liability for income taxes. Any such adjustment could be material to the Company’s results of operations for any given quarterly or annual period based, in part, upon the results of operations for the given period. As of December 31, 207 and 2016, management considered that the Company had no uncertain tax positions, and will continue to evaluate for uncertain positions in the future.

  

Concentration of credit risks:

  

Cash and cash equivalents: The Company maintains its cash in bank deposit accounts which, at times, may exceed federally insured limits. Accounts are guaranteed by the Federal Deposit Insurance Corporation (FDIC) up to $250,000. As of December 31, 2017 and 2016, the Company had $963,763 and $1,083,790 in excess of FDIC insured limits, respectively. The Company has not experienced any losses in such accounts.

  

Customers : The Company performs ongoing credit evaluations of its customers’ financial condition and generally, requires no collateral.

   

For the year ended December 31, 2017, five customers who accounted for more than 10% of the Company’s total net sales revenues, representing approximately 28%, 15%, 14%, 10%, and 10% of total net sales revenues, and 0%, 8%, 0%, 1%, and 69% of accounts receivable in aggregate at December 31, 2017, respectively:

 

Customer   Net Sales for the year
2017
    A/R balance as of
December 31,
2017
 
A   $ 273,966     $ -  
B   $ 150,450     $ 15,950  
C   $ 141,674     $ -  
D   $ 98,000     $ 2,300  
E   $ 88,085     $ 134,312 *

 

For the year ended December 31, 2016, four customers who accounted for more than 10% of the Company’s total net sales revenues, representing approximately 50%, 13%, 11%, and 10% of total net sales revenues, and 70%, 1%, 0%, and 12% of accounts receivable in aggregate at December 31, 2016, respectively:

  

Customer   Net Sales for the year
2016
    A/R balance as of
December 31,
2016
 
A   $ 770,736     $ 175,900 *
B   $ 201,039     $ 2,259  
C   $ 166,665     $ -  
D   $ 153,071     $ 30,506  

 

*Related party transactions (See Note 3).

  

9

 

 

Suppliers: The Company currently is not entering any significant purchase agreements with suppliers for the years ended December 31, 2017 and 2016.

  

Fair value measurements: FASB ASC 820, “Fair Value Measurements” defines fair value for certain financial and nonfinancial assets and liabilities that are recorded at fair value, establishes a framework for measuring fair value and expands disclosures about fair value measurements. It requires that an entity measure its financial instruments to base fair value on exit price, maximize the use of observable units and minimize the use of unobservable inputs to determine the exit price. It establishes a hierarchy which prioritizes the inputs to valuation techniques used to measure fair value. This hierarchy increases the consistency and comparability of fair value measurements and related disclosures by maximizing the use of observable inputs and minimizing the use of unobservable inputs by requiring that observable inputs be used when available. Observable inputs are inputs that reflect the assumptions market participants would use in pricing the assets or liabilities based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s own assumptions about the assumptions market participants would use in pricing the asset or liability developed based on the best information available in the circumstances. The hierarchy prioritizes the inputs into three broad levels based on the reliability of the inputs as follows:

  

  Level 1 – Inputs are quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date. Valuation of these instruments does not require a high degree of judgment as the valuations are based on quoted prices in active markets that are readily and regularly available.
     
  Level 2 – Inputs other than quoted prices in active markets that are either directly or indirectly observable as of the measurement date, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
     
  Level 3 – Valuations based on inputs that are unobservable and not corroborated by market data. The fair value for such assets and liabilities is generally determined using pricing models, discounted cash flow methodologies, or similar techniques that incorporate the assumptions a market participant would use in pricing the asset or liability.

 

The carrying values of certain assets and liabilities of the Company, such as cash and cash equivalents, accrued liabilities, and due to related parties, approximate fair value due to their relatively short maturities.

 

Stock-based compensation: The Company measures expense associated with all employee stock-based compensation awards using a fair value method and recognizes such expense in the financial statements on a straight-line basis over the requisite service period in accordance with ASC Topic 718 “Compensation-Stock Compensation”. During the years ended December 31, 2017 and 2016, the Company did not record any employee stock-based compensation expenses.

  

The Company accounted for stock-based compensation to non-employees in accordance with ASC Topic 505-50 “Equity-Based Payments to Non-Employees” which requires that the cost of services received from non-employees is measured at fair value at the earlier of the performance commitment date or the date service is completed and recognized over the period the service is provided. During the years ended December 31, 2017 and 2016, the Company did not record any non-employee stock-based compensation expenses.

   

Profit sharing plan: The Company has a 401 (k) profit sharing plan for employees who have reached the age of twenty-one and have completed one year of eligibility service. The Company’s contribution is based on management’s discretion. In addition, the Company may make a nonelective contributions to the plan. The amount of the nonelective contribution is determined by its Board of Directors on an annual basis. Total contributions that the Company made to the plan were $0 for the years ended December 31, 2017 and 2016.

 

10

 

 

Recently issued accounting pronouncements: In February 2016, the FASB issued ASU No. 2016-02, “Leases.” The core principle of the ASU is that a lessee should recognize the assets and liabilities that arise from its leases other than those that meet the definition of a short-term lease. The ASU requires extensive qualitative and quantitative disclosures, including with respect to significant judgments made by management. Subsequently, the FASB issued ASU No. 2017-13, in September 2017 and ASU No. 2018-01, in January 2018, which amends and clarifies ASU 2016-02. The ASU will be effective for the Company beginning January 1, 2019, including interim periods in the fiscal year 2019. Early adoption is permitted. The Company is in the process of determining the method of adoption and assessing the impact of this ASU on its consolidated results of operations, cash flows, financial position and disclosures.

 

In March 2016, the FASB issued ASU 2016-08, Revenue from Contracts with Customers (Topic 606): Principal versus Agent Considerations (Reporting Revenue Gross versus Net). In April 2016, the FASB issued ASU 2016-10, Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing. In May 2016, the FASB issued ASU 2016-12, Revenue from Contracts with Customers (Topic 606): Narrow-Scope Improvements and Practical Expedients and ASU 2016-11, Revenue Recognition (Topic 605) and Derivatives and Hedging (Topic 815): Rescission of SEC Guidance Because of Accounting Standards Updates 2014-09 and 2014-16 Pursuant to Staff Announcements at the March 3, 2016 EITF Meeting. In December 2016, the FASB issued ASU 2016-20, Technical Corrections and Improvements to Topic 606, Revenue from Contracts with Customers. In September 2017, the FASB issued ASU 2017-13, Revenue Recognition (Topic 605), Revenue from Contracts with Customers (Topic 606), Leases (Topic 840), and Leases (Topic 842). These amendments provide additional clarification and implementation guidance on the previously issued ASU 2014-09, Revenue from Contracts with Customers (Topic 606). The amendments in ASU 2016-08 clarify how an entity should identify the specified good or service for the principal versus agent evaluation and how it should apply the control principle to certain types of arrangements. ASU 2016-10 clarifies the following two aspects of ASU 2014-09: identifying performance obligations and licensing implementation guidance. ASU 2016-11 rescinds several SEC Staff Announcements that are codified in Topic 605, including, among other items, guidance relating to accounting for consideration given by a vendor to a customer, as well as accounting for shipping and handling fees and freight services. ASU 2016-12 provides clarification to Topic 606 on how to assess collectability, present sales tax, treat noncash consideration, and account for completed and modified contracts at the time of transition. ASU 2016-12 clarifies that an entity retrospectively applying the guidance in Topic 606 is not required to disclose the effect of the accounting change in the period of adoption. Additionally, ASU 2016-20 clarifies certain narrow aspects within Topic 606 including its scope, contract cost accounting, and disclosures. The new guidance requires enhanced disclosures, including revenue recognition policies to identify performance obligations to customers and significant judgments in measurement and recognition. The effective date and transition requirements for these amendments are the same as the effective date and transition requirements of ASU 2014-09, which is effective for fiscal years, and for interim periods within those years, beginning after December 15, 2017. The Company is currently evaluating the overall impact that ASU 2014-09 and its related amendments will have on the Company’s financial statements.

 

On December 22, 2017, the SEC issued Staff Accounting Bulletin (“SAB 118”), which provides guidance on accounting for tax effects of the Tax Act. SAB 118 provides a measurement period that should not extend beyond one year from the Tax Act enactment date for companies to complete the accounting under ASC 740. In accordance with SAB 118, a company must reflect the income tax effects of those aspects of the Act for which the accounting under ASC 740 is complete. In March 2018, the FASB issued ASU 2018-05, Amendments to SEC Paragraphs Pursuant to SEC Staff Accounting Bulletin No. 118 (SEC Update), Income Taxes (Topic 740). ASU 2018-05 provides guidance regarding the recording of tax impacts where uncertainty exists, in the period of adoption of the 2017 U.S. Tax Cuts and Jobs Act (the “2017 Tax Act”). To the extent that a company’s accounting for certain income tax effects of the Tax Act is incomplete but it is able to determine a reasonable estimate, it must record a provisional estimate to be included in the financial statements. If a company cannot determine a provisional estimate to be included in the financial statements, it should continue to apply ASC 740 on the basis of the provision of the tax laws that were in effect immediately before the enactment of the Tax Act. While the Company is able to make reasonable estimates of the impact of the reduction in corporate rate and the deemed repatriation transition tax, the final impact of the Tax Act may differ from these estimates, due to, among other things, changes in our interpretations and assumptions, additional guidance that may be issued by the I.R.S., and actions we may take. The Company is continuing to gather additional information to determine the final impact.

  

11

 

 

NOTE 2. Property and Equipment

  

The following is a summary of the Company’s property and equipment as of December 31, 2017 and 2016:

      

    2017     2016  
Laboratory and manufacturing equipment   $ 829,999     $ 822,205  
Office equipment     6,081       6,081  
Leasehold improvements     1,994,585       1,994,585  
Furniture and fixtures     106,510       106,510  
Subtotal     2,937,175       2,929,381  
Less: accumulated depreciation     (2,899,575 )     (2,888,195 )
Property and equipment, net   $ 37,600     $ 41,186  

  

Total depreciation expense was $11,380 and $9,314 for the years ended December 31, 2017 and 2016, respectively.

  

NOTE 3. Related Party Transactions

 

Operating lease

  

The Company has subleased a portion of its office space to Amkey Ventures, LLC, (the “Amkey”) since June 21, 2001. The sublease is automatically renewed on an annual basis. Amkey is incorporated in the State of California on April 23, 2001. Mr. George J Lee, the Chairman of the Company, is one of managers of Amkey. The sublease is classified as an operating lease and the original lessee shall continue to account for the original lease as it did before commencement of the sublease. Pursuant to ASC 842-20-35-14, the nature of this sublease is such that the original lessee is not relieved of the primary obligation under the original lease, the original lessee (as sublessor) shall continue to account for the original lease. The rental income was $4,800 and $5,600 for the years ended December 31, 2017 and 2016, respectively. Accordingly, the Company recorded the rental income as a reduction of rent expenses for the years ended December 31, 2017 and 2016.

 

Related party sales transaction

  

Genepharm Inc., (the “Genepharm”), was incorporated on March 6, 2000 in the State of California. Mr. George J Lee is the Chairman of both Genepharm and the Company. The Company had net sales of $88,085 and $770,736 to Genepharm for the years ended December 31, 2017 and 2016, respectively. As of December 31, 2017 and 2016, the Company also had accounts receivable of $134,312 and $175,900 due from Genepharm.

  

Due to shareholders

  

The Company has advanced funds from its shareholder and Chairman for working capital purposes. The Company has not entered into any agreement on the repayment terms for these advances. The advances bear no interest rate and are due upon demand by its shareholder and Chairman. As of December 31, 2017 and 2016, the outstanding advances were $5,800.

 

12

 

 

NOTE 4. Accrued Expenses and Other Current Liabilities

  

Accrued expenses and other current liabilities as of December 31, 2017 and 2016 consisted of:

  

    2017     2016  
Accrued professional fees   $ 35,756     $ 37,792  
Accrued vacation     19,541       16,136  
Others     2,279       1,684  
    $ 57,576     $ 55,612  

  

NOTE 5. Stock-Based Compensation

  

2000 Stock Plan

  

The Company’s board of directors adopted, and its stockholders approved its 2000 Stock Plan (the “2000 Plan”) in August 2000, providing for the issuance under 2000 Plan of options and rights to purchase up to one million (1,000,000) shares of common stock. As of December 31, 2017 and 2016, there were nil shares available for issuance under the Company’s 2000 Plan, which provides for the grant of incentive stock options and nonstatutory stock options to employees, directors, and consultants.

  

The exercise price of incentive stock options under the 2000 Plan may not be less than 100% of the fair market value per share of the common stock on the date of grant. Notwithstanding the above, if an incentive stock option is granted to an employee who owns more than ten percent of the total combined voting power of all classes of stock of the Company or any subsidiary, the exercise price shall be not less than 110% of the fair market value per share of the common stock on the date of grant. The exercise price of nonstatutory stock options under the 2000 Plan may not be less than 85% of the fair market value per share of the common stock on the date of grant. Notwithstanding the above, if a nonstatutory stock option is granted to a person who owns more than ten percent of the total combined voting power of all classes of stock of the Company or any subsidiary, the exercise price shall be not less than 110% of the fair market value per share of the common stock on the date of grant.

  

All stock options under the 2000 Plan have a term of no greater than 10 years from the date of grant. However, in the case of an option granted to an optionee who, at the time the optionee is granted, owns stock representing more than ten percent of the voting power of all classes of stock of the Company or subsidiary, the term of the option shall be 5 years from the date of grant or such shorter term as may be provided in the option agreement.

  

Vesting of stock options is determined by the board of directors of the Company. No stock option may be exercised subsequent to its termination date. The purchase price of a right to purchase common stock and the termination date of the offer under the 2000 Plan is determined by the board of directors of the Company. The Company shall have the right to repurchase all or a portion of the shares acquired pursuant to the exercise of this option in the event that the participant’s continuous service should terminate for any reason whatsoever.

  

2015 Stock Plan

  

The Company’s board of directors adopted, and its stockholders approved its 2015 Stock Plan (the “2015 Plan”) in March 2015, providing for the issuance under 2015 Plan of options and rights to purchase up to Four million two hundred and fifty thousand (4,250,000) shares of common stock. As of December 31, 2017 and 2016, there were 918,843 shares available for issuance under the Company’s 2015 Plan, which provides for the grant of incentive stock options and nonstatutory stock options to employees, directors, and consultants.

  

The exercise price of incentive stock options under the 2015 Plan shall be no less than 100% of the fair market value per share of the common stock on the date of grant. Notwithstanding the above, if an incentive stock option is granted to an employee who owns more than ten percent of the total combined voting power of all classes of stock of the Company or any subsidiary, the exercise price shall be no less than 110% of the fair market value per share of the common stock on the date of grant. The exercise price of nonstatutory stock options under the 2015 Plan shall be no less than 100% of the fair market value per share of the common stock on the date of grant.

  

13

 

 

All stock options under the 2015 Plan have a term of no greater than 10 years from the date of grant. However, in the case of an option granted to an optionee who, at the time the optionee is granted, owns stock representing more than ten percent of the voting power of all classes of stock of the Company or subsidiary, the term of the option shall be 5 years from the date of grant or such shorter term as may be provided in the option agreement.

  

Vesting of stock options is determined by the board of directors of the Company. No stock option may be exercised subsequent to its termination date. The purchase price of a right to purchase common stock and the termination date of the offer under the 2015 Plan is determined by the board of directors of the Company. The Company shall have the right to repurchase all or a portion of the shares acquired pursuant to the exercise of this option in the event that the participant’s continuous service should terminate for any reason whatsoever.

  

The fair value of each stock option granted under both 2015 and 2000 Plan was estimated on the date of grant using the Black-Scholes option pricing model with the following assumptions:

  

    Year Ended
December 31,
 
    2017     2016  
Weighted average fair value of common stock on date of grant   $ 0.30     $ 0.30  
Weighted average exercise price of the options   $ N/A     $ N/A  
Weighted average exercise price of options outstanding at end of period   $ 0.14     $ 0.14  
Expected term of the options (years)     4       4  
Expected volatility (%)     30 %     30 %
Risk-free interest rate     4.0 %     4.0 %
Dividend yield     N/A       N/A  
Expected forfeiture per year (%)     3 %     3 %
Weighted average fair value of the options per unit   $ 0.30     $ 0.30  

 

* No stock options were granted  during the years ended December 31, 2017 and 2016

 

Compensation expense related to stock-based transactions is measured and recognized in the financial statements based on the fair value of the awards granted. The stock-based compensation expense, net of forfeitures, is recognized on a straight-line basis over the requisite service periods of the awards, which is generally three to four years.

  

Use of the Black-Scholes option pricing model requires the input of subjective assumptions, including the fair value of the underlying common stock, expected term of the option, expected volatility of the price of the common stock, risk-free interest rates, and expected dividend yield of the common stock. The assumptions used in the option-pricing model represent management’s best estimates.

  

These assumptions and estimates are as follows:

 

Fair Value of Common Stock

The fair value of the common stock underlying its stock-based awards was primarily based on the latest financing rounds of issuing equity interest near the option grant date. It was determined by the Company’s board of directors, with input from management and a third-party valuation firm.

  

Expected Term  

The expected term assumptions were determined based on the vesting terms, exercise terms, and contractual lives of the options.

  

14

 

 

Expected Volatility

The expected volatility of stock options is estimated based upon the historical volatility of a number of publicly traded companies in similar stages of development and comparable industries for a period commensurate with the expected life.

 

Risk-Free Interest Rate

The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the time of grant for zero-coupon U.S. Treasury notes with maturities approximately equal to the option’s expected term.

  

Dividend Yield

The Company has never declared or paid any cash dividends and does not presently plan to pay cash dividends in the foreseeable future. Consequently, an expected dividend yield of zero was utilized.

 

Expected Forfeitures

The Company considers many factors when estimating expected forfeitures, including economic environment, and historical experience. The Company updates its estimated forfeiture rate annually.

  

The following table summarizes the stock option activity under the 2000 and 2015 Plan and related information:

 

Options Outstanding
    Number of           Weighted-  
    Shares           Average  
    Underlying     Weighted-     Remaining  
    Outstanding     Average     Contractual  
    Options     Exercise Price     Life (Years)  
Outstanding – January 1, 2016     49,767       0.23       6.46  
Granted     -       N/A       -  
Exercised     -       N/A       -  
Forfeited or cancelled     (4,000 )     N/A       -  
Outstanding – December 31, 2016     45,767       0.24       5.97  
Granted     -       N/A       -  
Exercised     -       N/A       -  
Forfeited or cancelled     (32,356 )     N/A       -  
Outstanding – December 31, 2017     13,411       0.25       5.72  
                         
Exercisable – December 31, 2017     13,411     $ 0.25       5.72  
                         
Vested and expected to vest – December 31, 2017     13,411     $ 0.25       5.72  
                         
Exercisable – December 31, 2016     45,767     $ 0.24       5.97  
                         
Vested and expected to vest – December 31, 2016     45,767     $ 0.24       5.97  

 

The weighted-average grant-date fair value of options granted during the years ended December 31, 2017 and 2016 was $0.25 and $0.24 per share, respectively. The total fair value of options vested during the years ended December 31, 2017 and 2016 was $0.

  

15

 

  

NOTE 6. Operating Lease Obligation

  

The Company leases its main office in Fremont, California, under operating leases expiring on February 28, 2021. The monthly rent is approximately $23,600. The Company also leases an office equipment with monthly payment of approximately $220 expiring on August 31, 2019. The total rent expenses were $274,978 and $255,240 for the years ended December 31, 2017 and 2016, respectively.

  

Future minimum lease payments under the Company’s operating leases are as follows:

 

As of December 31,   Amount  
2018   $ 298,246  
2019     304,430  
2020     309,942  
2021     51,860  
Total   $ 964,478  

  

NOTE 7. Income Taxes

  

The Company files income tax returns in the U.S. federal jurisdiction, and various state and local jurisdictions. The Company is no longer subject to U.S. federal, state and local income tax examinations by tax authorities for years before 2013.

  

On December 22, 2017   H.R 1, originally known as the Tax Cuts and Jobs Act, (the “Tax Act”) was enacted. Among the significant changes to the U.S. Internal Revenue Code, the Tax Act lowers the U.S. federal corporate income tax rate (“Federal Tax Rate”) from 35% to 21% effective January 1, 2018 The 21% Federal Tax Rate will apply to earnings reported for the full 2018   fiscal year. In addition, the Company must re-measure its net deferred tax assets and liabilities using the Federal Tax Rate that will apply when these amounts are expected to reverse. As of December 31, 2017, the Company can determine a reasonable estimate for certain effects of tax reform and is recording that estimate as a provisional amount. The provisional remeasurement of the deferred tax assets and allowance valuation of deferred tax assets at December 31, 2017 resulted in a net effect of $0 discrete tax expenses (benefit) which lowered the effective tax rate by 14% for the year ended December 31, 2017. The provisional remeasurement amount is anticipated to change as data becomes available allowing more accurate scheduling of the deferred tax assets and liabilities primarily related to net operating loss carryover.

  

Components of income tax (benefits) for the years ended December 31, 2017 and 2016 are as follows:

  

    For the year ended December 31, 2017     For the year ended December 31, 2016  
    Federal     State     Total     Federal     State     Total  
Current   $ -     $ 800     $ 800     $ -     $ 800     $ 800  
Deferred     -       -       -       -       -       -  
    $ -     $ 800     $ 800     $ -     $ 800     $ 800  

  

16

 

 

Significant components of the Company’s deferred tax accounts at December 31, 2017 and 2016:

  

    December 31,
2017
    December 31,
2016
 
Deferred Tax Account - noncurrent:            
Allowance for Doubtful Accounts   $ 20,846     $ 20,618  
Reserve for Obsolete Inventory     177       177  
Accrued Vacation     5,468       4,515  
Accumulated Depreciation     (2,703 )     31,462  
Tax Net Operating Loss Carryforwards     3,740,797       3,815,625  
General Business Credit     1,316,980       1,253,229  
Less: Valuation allowance     (5,081,565 )     (5,125,626 )
Total deferred tax account - noncurrent   $ -     $ -  

 

The difference between the effective rate reflected in the provision for income taxes on loss before taxes and the amounts determined by applying the applicable statutory U.S. tax rate are analyzed below:

 

    2017     2016  
Statutory tax benefit, net of state effects     31 %     31 %
State income taxes     8.84 %     8.84 %
Provisional remeasurement of deferred taxes     (12 )%     - %
Nondeductible/nontaxable items     - %     - %
Change in valuation allowance     (27.84 )%     (39.84 )%
Effective income tax rate     - %     - %

  

NOTE 8. Subsequent Events

 

The Company has evaluated subsequent events through the date which the financial statements were available to be issued. All subsequent events requiring recognition as of December 31, 2017 have been incorporated into these financial statements and there are no subsequent events that require disclosure in accordance with FASB ASC Topic 855, “Subsequent Events.”

 

17

Exhibit 99.4

 

Biokey, Inc.

 

FINANCIAL STATEMENTS FOR THE NINE MONTHS ENDED

 

SEPTEMBER 30, 2018 and 2017

 

 

 

 

BIOKEY, INC.

BALANCE SHEETS

 

    September 30,     December 31,  
    2018     2017  
    (Unaudited)        
ASSETS            
Current Assets            
Cash and cash equivalents   $ 733,843     $ 1,225,397  
Accounts receivable, net     83,479       59,080  
Accounts receivable - related parties, net     142,225       134,312  
Total Current Assets     959,547       1,418,789  
                 
Property and equipment, net     64,375       37,600  
Security deposits     10,440       10,440  
Total Assets   $ 1,034,362     $ 1,466,829  
                 
LIABILITIES AND EQUITY                
Current Liabilities                
Accounts payable   $ 12,013     $ 5,396  
Due to shareholders     -       5,800  
Accrued expenses and other current liabilities     60,691       57,576  
Advance from customers     12,276       10,985  
Total Current Liabilities     84,980       79,757  
                 
Non-current Liabilities                
Tenant security deposit     2,880       2,880  
Total Liabilities     87,860       82,637  
                 
Equity                
Preferred stock, no par value, 23,562,000 shares authorized:                
7,000,000 shares of Series A issued and outstanding at September 30, 2018 and December 31, 2017     3,500,000       3,500,000  
1,160,000 shares of Series B issued and outstanding at September 30, 2018 and December 31, 2017     1,160,000       1,160,000  
13,973,097 shares of Series C issued and outstanding at September 30, 2018 and December 31, 2017     13,973,097       13,973,097  
                 
Common stock, no par value; 30,000,000 shares authorized,7,418,134 and 6,498,134 shares issued and outstanding at September 30, 2018 and December 31, 2017, respectively     771,793       541,793  
Additional paid-in capital     82,265       296,465  
Accumulated deficit     (18,540,653 )     (18,087,163 )
Total Equity     946,502       1,384,192  
                 
Total Liabilities and Equity   $ 1,034,362     $ 1,466,829  

 

The accompanying notes are an integral part of the financial statements.

 

2

 

 

BIOKEY, INC.

STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)

(UNAUDITED)

 

    Three Months Ended
September 30,
    Nine Months Ended
September 30,
 
    2018     2017     2018     2017  
                         
Revenues   $ 163,459     $ 473,359     $ 382,097     $ 808,140  
Cost of revenues     744       7,456       3,215       14,092  
Gross profit     162,715       465,903       378,882       794,048  
                                 
Operating expenses                                
Research and development expenses     144,562       124,205       337,810       373,690  
Selling, general and administrative expenses     118,874       206,973       498,396       596,865  
Total operating expenses     263,436       331,178       836,206       970.555  
                                 
Income (loss) from operations     (100,721 )     134,725       (457,324 )     (176,507 )
                                 
Other income (expense)                                
Interest income     3,101       1,047       4,144       5,051  
Other income     151       46       490       150  
Total other income     3,252       1,093       4,634       5,201  
                                 
Income (loss) before income tax     (97,469 )     135,818       (452,690 )     (171,306 )
Provision for income tax     800       800       800       800  
Net income (loss) and comprehensive income (loss)   $ (98,269 )   $ 135,018     $ (453,490 )   $ (172,106 )

 

The accompanying notes are an integral part of the financial statements.

 

3

 

 

BIOKEY, INC.

STATEMENTS OF CASH FLOWS

FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2018 AND 2017

(UNAUDITED)

 

    2018     2017  
Cash flows from operating activities            
Net loss   $ (453,490 )   $ (172,106 )
Adjustments to reconcile net loss to net cash used in operating activities:                
Depreciation and amortization     19,486       8,618  
Changes in assets and liabilities:                
Decrease (increase) in accounts receivable     (32,312 )     (199,262 )
Decrease (increase) in other receivable     -       6,000  
Increase (decrease) in accounts payable     6,617       154,022  
Increase (decrease) in accrued expenses and other liabilities     3,115       5,574  
Increase (decrease) in advanced from others     1,291       (4,280 )
Net cash used in operating activities     (455,293 )     (201,434 )
                 
Cash flows from investing activities                
Purchase of equipment     (46,261 )     (7,794 )
Net cash used in investing activities     (46,261 )     (7,794 )
                 
Cash flows from financing activities                
Proceeds from issuance of common stock     10,000       0  
Net cash provided by financing activities     10,000       0  
                 
Net decrease in cash and cash equivalents     (491,554 )     (209,228 )
                 
Cash and cash equivalents                
Beginning     1,225,397       1,473,262  
Ending   $ 733,843     $ 1,264,034  
                 
Supplemental disclosure of cash flows                
Cash paid during the year for:                
Income tax   $ 800     $ 800  
Interest expense   $ -     $ -  
Non-cash financing and investing activities                
Capital contribution by shareholders through debt conversion   $ 5,800     $ -  

 

The accompanying notes are an integral part of the financial statements.

 

4

 

 

BIOKEY, INC.

NOTES TO THE UNAUDITED FINAICAL STATEMENTS

SEPTEMBER 30, 2018

 

NOTE 1. Nature of Business and Significant Accounting Policies

 

Nature of Business: Biokey, Inc., (hereinafter, “the Company”), was incorporated on August 9, 2000 in the State of California. It is engaged primarily in research and development, manufacturing, and distribution of generic drugs and nutraceuticals with strategic partners. The Company provides a wide range of services, including, API characterization, pre-formulation studies, formulation development, analytical method development, stability studies, IND/NDA/ANDA/510K submissions, and manufacturing clinical trial materials (phase 1 through phase 3) and commercial manufacturing. The Company also licenses out its technologies and initiates joint research and development processes with other biotechnology, pharmaceutical, and nutraceutical companies.

 

A summary of the Company’s significant accounting policies is as follows:

 

Basis of presentation: The accompanying financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America.

 

Use of Estimates: The preparation of financial statements in conformity with generally accepted accounting principles of United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.

 

Cash and cash equivalents: For purposes of reporting cash flows, the Company considers all highly liquid debt instruments purchased with a maturity of three months or less to be cash equivalents.

 

Accounts receivable and other receivable: Accounts receivable and other receivables are stated at carrying value less estimates made for doubtful receivables. An allowance for impairment of trade receivable and other receivables is established if the collection of a receivable becomes doubtful. Such receivable becomes doubtful when there is objective evidence that the Company will not be able to collect all amounts due according to the original terms of the receivables. Significant financial difficulties of the debtor, probability that the debtor will enter into bankruptcy or financial reorganization, and default or delinquency in payments are considered indicators that the receivable is impaired. The amount of the allowance is the difference between the asset’s carrying amount and the present value of estimated future cash flows, discounted at the original effective interest rate.

 

Property and equipment: Property and equipment are recorded at cost. Depreciation is computed on the straight-line method over the estimated useful lives of the related assets as follows:

 

Laboratory and manufacturing equipment 2 ~5 years
Office equipment 3 years
Leasehold improvement 3 ~8 years
Furniture and fixtures 8~15 years

 

Expenditures for major renewals and betterment that extend the useful lives of property and equipment are capitalized. Expenditures for repairs and maintenance are charged to expense as incurred. When property and equipment are retired or otherwise disposed of, the asset and accumulated depreciation are removed from the accounts and the resulting profit or loss is reflected in the statement of operations for the period.

 

Impairment of long-lived assets: The Company reviews its long-lived assets whenever events or circumstances indicate that the carrying amount of such assets may not be recoverable. Impairment is evaluated by comparing the carrying value of the long-lived assets with the estimated future net undiscounted cash flows expected to result from the use of the assets, including cash flows from disposition. Should the sum of the expected future net cash flows be less than the carrying value, the Company would recognize an impairment loss at that date. An impairment loss would be measured by comparing the amount by which the carrying value exceeds the fair value (estimated discounted future cash flows) of the long-lived assets.

 

5

 

 

Revenue recognition: During the fiscal year 2018, the Company adopted Accounting Standards Codification (“ASC”), Topic 606 (ASC 606), Revenue from Contracts with Customers, using the modified retrospective method to all contracts that were not completed as of January 1, 2018, and applying the new revenue standard as an adjustment to the opening balance of accumulated deficit at the beginning of 2018 for the cumulative effect. The results for the Company’s reporting periods beginning on and after January 1, 2018 are presented under ASC 606, while prior period amounts are not adjusted and continue to be reported under the accounting standards in effect for the prior period. Based on the Company’s review of existing contracts as of January 1, 2018, the Company concluded that the adoption of the new guidance did not have a significant change on the Company’s revenue during all periods presented.

 

Pursuant to ASC 606, the Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the Company expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines is within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the Company will collect the consideration the Company is entitled to in exchange for the goods or services the Company transfers to the customers. At inception of the contract, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract, determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Generally, the Company's performance obligations are transferred to customers at a point in time, typically upon delivery.

 

The Company currently only has one major revenue source, which is research and development activities services.

 

Revenues related to research and development and regulatory activities are recognized when the related services or activities are performed, in accordance with the contract terms. The Company typically has only one performance obligation at the inception of a contract, which is to perform research and development services. The Company may also provide its customers with an option to request that the Company provides additional goods or services in the future, such as active pharmaceutical ingredient, API, or IND/NDA/ANDA/510K submissions. The Company evaluates whether these options are material rights at the inception of the contract. If the Company determines an option is a material right, the Company will consider the option a separate performance obligation.

 

If the Company is entitled to reimbursement from its customers for specified research and development expenses, the Company accounts for the related services that it provides as separate performance obligations if it determines that these services represent a material right. The Company also determines whether the reimbursement of research and development expenses should be accounted for as revenues or an offset to research and development expenses in accordance with provisions of gross or net revenue presentation. The Company recognizes the corresponding revenues or records the corresponding offset to research and development expenses as it satisfies the related performance obligations.

 

The Company then determines the transaction price by reviewing the amount of consideration the Company is eligible to earn under the contracts, including any variable consideration. Under the outstanding contracts, consideration typically includes fixed consideration and variable consideration in the form of potential milestone payments. At the start of an agreement, the Company’s transaction price usually consists of the payments made to or by the Company based on the number of full-time equivalent researchers assigned to the project and the related research and development expenses incurred. The Company does not typically include any payments that the Company may receive in the future in its initial transaction price because the payments are not probable. The Company would reassess the total transaction price at each reporting period to determine if the Company should include additional payments in the transaction price.

 

The Company receives payments from its customers based on billing schedules established in each contract. Upfront payments and fees may be recorded as advance from customers upon receipt or when due, and may require deferral of revenue recognition to a future period until the Company performs its obligations under these arrangements. Amounts are recorded as accounts receivable when the right of the Company to consideration is unconditional. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the customers and the transfer of the promised goods or services to the customers will be one year or less.

  

6

 

 

Advertising costs: Advertising costs are expensed as incurred. The total advertising and marketing expenses were $0 for the three and nine months ended September 30, 2018 and 2017.

 

Research and Development: The Company accounts for R&D costs in accordance with Accounting Standards Codification (“ASC”) 730, Research and Development (“ASC 730”). Research and development expenses are charged to expense as incurred unless there is an alternative future use in other research and development projects or otherwise. Research and development expenses are comprised of costs incurred in performing research and development activities, including personnel-related costs, facilities-related overhead, and outside contracted services including clinical trial costs, manufacturing and process development costs for both clinical and preclinical materials, research costs, and other consulting services. Non-refundable advance payment for goods and services that will be used in future research and development activities are expensed when the activity has been performed or when the goods have been received rather than when the payment is made. In instances where the Company enters into agreements with third parties to provide research and development services, costs are expensed as services are performed.

  

Income taxes: The Company accounts for income taxes in accordance with ASC 740, Income Taxes, which requires that the Company recognize deferred tax liabilities and assets based on the differences between the financial statement carrying amounts and the tax basis of assets and liabilities, using enacted tax rates in effect in the years the differences are expected to reverse. Deferred income tax benefit (expense) results from the change in net deferred tax assets or deferred tax liabilities. A valuation allowance is recorded when, in the opinion of management, it is more likely than not that some or all of any deferred tax assets will not be realized. The Company provides criteria for the recognition, measurement, presentation and disclosure of uncertain tax position.

 

Valuation of Deferred Tax Assets: A valuation allowance is recorded to reduce its deferred tax assets to the amount that is more likely than not to be realized. In assessing the need for the valuation allowance, management considers, among other things, projections of future taxable income and ongoing prudent and feasible tax planning strategies. If the Company determines that sufficient negative evidence exists, then it will consider recording a valuation allowance against a portion or all of the deferred tax assets in that jurisdiction. If, after recording a valuation allowance, the Company’s projections of future taxable income and other positive evidence considered in evaluating the need for a valuation allowance prove, with the benefit of hindsight, to be inaccurate, it could prove to be more difficult to support the realization of its deferred tax assets. As a result, an additional valuation allowance could be required, which would have an adverse impact on its effective income tax rate and results. Conversely, if, after recording a valuation allowance, the Company determines that sufficient positive evidence exists in the jurisdiction in which the valuation allowance was recorded, it may reverse a portion or all of the valuation allowance in that jurisdiction. In such situations, the adjustment made to the deferred tax asset would have a favorable impact on its effective income tax rate and results in the period such determination was made. See Note 7 for information related to income taxes, including the recorded balances of its valuation allowance related to deferred tax assets.

 

The Company applied the provisions of ASC 740-10-50, “Accounting For Uncertainty In Income Taxes”, which provides clarification related to the process associated with accounting for uncertain tax positions recognized in its financial statements. Audit periods remain open for review until the statute of limitations has passed. The completion of review or the expiration of the statute of limitations for a given audit period could result in an adjustment to the Company’s liability for income taxes. Any such adjustment could be material to the Company’s results of operations for any given quarterly or annual period based, in part, upon the results of operations for the given period. As of September 30, 2018 and December 31, 2017, management considered that the Company had no uncertain tax positions, and will continue to evaluate for uncertain positions in the future.

 

Concentration of credit risks:

 

Cash and cash equivalents: The Company maintains its cash in bank deposit accounts which, at times, may exceed federally insured limits. Accounts are guaranteed by the Federal Deposit Insurance Corporation (FDIC) up to $250,000. As of September 30, 2018 and December 31, 2017, the Company had $452,776 and $963,763 in excess of FDIC insured limits, respectively. The Company has not experienced any losses in such accounts.

 

Customers: The Company performs ongoing credit evaluations of its customers’ financial condition and generally, requires no collateral.

 

7

 

 

For the nine months ended September 30, 2018, three customers who accounted for more than 10% of the Company’s total net sales revenues, representing approximately 43.9%, 16.8%, and 12.8% of total net sales revenues, and 17.7%, 0.1%, and 16.9% of accounts receivable in aggregate at September 30, 2018, respectively:

 

Customer   Net sales for the
nine months ended September 30,
2018
    A/R balance
as of
September 30,
2018
 
A   $ 167,596     $ 39,843  
B   $ 64,355     $ 200  
C   $ 48,972     $ 38,187  

 

For the nine months ended September 30, 2017, five customers who accounted for more than 10% of the Company’s total net sales revenues, representing approximately 33.9%, 16.5%, 11.8%, 11.3%, and 10.9% of total net sales revenues, and 44.2%, 21%, 0.5%, 1.0%, and 29.5% of accounts receivable in aggregate at September 30, 2017, respectively:

 

Customer   Net sales
for the
nine months ended September 30,
2017
    A/R balance
as of
September 30,
2017
 
E   $ 274,209     $ 198,960  
F   $ 133,600     $ 94,400  
G   $ 95,700     $ 2,300  
H   $ 91,574     $ 4,308  
I   $ 87,960     $ 132,775 *

 

* Related party transactions (See Note 3).

 

Suppliers: The Company currently is not entering any significant purchase agreements with suppliers for the nine months ended September 30, 2018 and 2017.

 

Fair Value Measurements: FASB ASC 820, “Fair Value Measurements” defines fair value for certain financial and nonfinancial assets and liabilities that are recorded at fair value, establishes a framework for measuring fair value and expands disclosures about fair value measurements. It requires that an entity measure its financial instruments to base fair value on exit price, maximize the use of observable units and minimize the use of unobservable inputs to determine the exit price. It establishes a hierarchy which prioritizes the inputs to valuation techniques used to measure fair value. This hierarchy increases the consistency and comparability of fair value measurements and related disclosures by maximizing the use of observable inputs and minimizing the use of unobservable inputs by requiring that observable inputs be used when available. Observable inputs are inputs that reflect the assumptions market participants would use in pricing the assets or liabilities based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s own assumptions about the assumptions market participants would use in pricing the asset or liability developed based on the best information available in the circumstances. The hierarchy prioritizes the inputs into three broad levels based on the reliability of the inputs as follows:

 

 

Level 1 – Inputs are quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date. Valuation of these instruments does not require a high degree of judgment as the valuations are based on quoted prices in active markets that are readily and regularly available.

     
 

Level 2 – Inputs other than quoted prices in active markets that are either directly or indirectly observable as of the measurement date, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.

     
 

Level 3 – Valuations based on inputs that are unobservable and not corroborated by market data. The fair value for such assets and liabilities is generally determined using pricing models, discounted cash flow methodologies, or similar techniques that incorporate the assumptions a market participant would use in pricing the asset or liability.

 

The carrying values of certain assets and liabilities of the Company, such as cash and cash equivalents, accounts receivable, accrued liabilities, and advance from customers, approximate fair value due to their relatively short maturities.

 

8

 

 

Stock-Based Compensation: The Company measures expense associated with all employees and non-employee directors and consultants’ stock-based compensation awards using a fair value method and recognizes such expense in the financial statements on a straight-line basis over the requisite service period in accordance with ASC Topic 718 “Compensation-Stock Compensation”. During the three and nine months ended September 30, 2018 and 2017, the Company did not record any stock-based compensation expenses.

 

Profit Sharing Plan: The Company has a 401 (k) profit sharing plan for employees who have reached the age of twenty-one and have completed one year of eligibility service. The Company’s contribution is based on management’s discretion. In addition, the Company may make a nonelective contributions to the plan. The amount of the nonelective contribution is determined by its Board of Directors on an annual basis. Total contributions that the Company made to the plan were $0 for the nine months ended September 30, 2018 and 2017.

 

Recently Issued Accounting Pronouncements: In February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-02, Leases (Topic 842), which amends the existing accounting standards for leases. The new standard requires lessees to record a right-of-use asset and a corresponding lease liability on the balance sheet (with the exception of short-term leases). For lessees, leases will continue to be classified as either operating or financing in the income statement. This ASU becomes effective in the first quarter of fiscal year 2019 and early adoption is permitted. This ASU is required to be applied with a modified retrospective approach and requires application of the new standard at the beginning of the earliest comparative period presented. In July 2018, the FASB issued ASU No. 2018-11, Leases (Topic 842): Targeted Improvements. In issuing ASU No. 2018-11, the FASB decided to provide another transition method in addition to the existing transition method by allowing entities to initially apply the new leases standard at the adoption date and recognize a cumulative-effect adjustment to the opening balance of retained earnings in the period of adoption. The Company is currently evaluating the impact that ASU 2016-02 and ASU 2018-11 will have on its condensed financial statements.

 

In March 2016, the FASB issued ASU 2016-08, Revenue from Contracts with Customers (Topic 606): Principal versus Agent Considerations (Reporting Revenue Gross versus Net) . In April 2016, the FASB issued ASU 2016-10, Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing . In May 2016, the FASB issued ASU 2016-12, Revenue from Contracts with Customers (Topic 606): Narrow-Scope Improvements and Practical Expedients and ASU 2016-11, Revenue Recognition (Topic 605) and Derivatives and Hedging (Topic 815): Rescission of SEC Guidance Because of Accounting Standards Updates 2014-09 and 2014-16 Pursuant to Staff Announcements at the March 3, 2016 EITF Meeting . In December 2016, the FASB issued ASU 2016-20, Technical Corrections and Improvements to Topic 606, Revenue from Contracts with Customers. In September 2017, the FASB issued ASU 2017-13, Revenue Recognition (Topic 605), Revenue from Contracts with Customers (Topic 606), Leases (Topic 840), and Leases (Topic 842). These amendments provide additional clarification and implementation guidance on the previously issued ASU 2014-09, Revenue from Contracts with Customers (Topic 606). The amendments in ASU 2016-08 clarify how an entity should identify the specified good or service for the principal versus agent evaluation and how it should apply the control principle to certain types of arrangements. ASU 2016-10 clarifies the following two aspects of ASU 2014-09: identifying performance obligations and licensing implementation guidance. ASU 2016-11 rescinds several SEC Staff Announcements that are codified in Topic 605, including, among other items, guidance relating to accounting for consideration given by a vendor to a customer, as well as accounting for shipping and handling fees and freight services. ASU 2016-12 provides clarification to Topic 606 on how to assess collectability, present sales tax, treat noncash consideration, and account for completed and modified contracts at the time of transition. ASU 2016-12 clarifies that an entity retrospectively applying the guidance in Topic 606 is not required to disclose the effect of the accounting change in the period of adoption. Additionally, ASU 2016-20 clarifies certain narrow aspects within Topic 606 including its scope, contract cost accounting, and disclosures. The new guidance requires enhanced disclosures, including revenue recognition policies to identify performance obligations to customers and significant judgments in measurement and recognition. The effective date and transition requirements for these amendments are the same as the effective date and transition requirements of ASU 2014-09, which is effective for fiscal years, and for interim periods within those years, beginning after December 15, 2017. The Company has adopted ASC 606 as of January 1, 2018.

 

9

 

 

On December 22, 2017, the SEC issued Staff Accounting Bulletin (“SAB 118”), which provides guidance on accounting for tax effects of the Tax Act. SAB 118 provides a measurement period that should not extend beyond one year from the Tax Act enactment date for companies to complete the accounting under ASC 740. In accordance with SAB 118, a company must reflect the income tax effects of those aspects of the Act for which the accounting under ASC 740 is complete.  In March 2018, the FASB issued ASU 2018-05, Amendments to SEC Paragraphs Pursuant to SEC Staff Accounting Bulletin No. 118 (SEC Update), Income Taxes (Topic 740). ASU 2018-05 provides guidance regarding the recording of tax impacts where uncertainty exists, in the period of adoption of the 2017 U.S. Tax Cuts and Jobs Act (the “2017 Tax Act”). To the extent that a company’s accounting for certain income tax effects of the Tax Act is incomplete but it is able to determine a reasonable estimate, it must record a provisional estimate to be included in the financial statements. If a company cannot determine a provisional estimate to be included in the financial statements, it should continue to apply ASC 740 on the basis of the provision of the tax laws that were in effect immediately before the enactment of the Tax Act. While the Company is able to make reasonable estimates of the impact of the reduction in corporate rate and the deemed repatriation transition tax, the final impact of the Tax Act may differ from these estimates, due to, among other things, changes in our interpretations and assumptions, additional guidance that may be issued by the I.R.S., and actions that the Company may take. The Company has accounted for the tax effects of the Tax Cuts and Jobs Act under the guidance of SAB 118, on a provisional basis. The Company’s accounting for certain income tax effects is incomplete, but the Company has determined reasonable estimates for those effects The Company is continuing to gather additional information to determine the final impact on its condensed financial statements.

 

In February 2018, the FASB issued Accounting Standards Update No. 2018-02 (“ASU 2018-02”), Income Statement - Reporting Comprehensive Income (Topic 220). The guidance in ASU 2018-02 allows an entity to elect to reclassify the stranded tax effects related to the Tax Cuts and Jobs Act (the Tax Act) of 2017 from accumulated other comprehensive income into retained earnings. ASU 2018-02 is effective for fiscal years beginning after December 15, 2018, with early adoption permitted. The Company is currently evaluating the effect this standard will have on its condensed financial statements.

 

In June 2018, the FASB issued ASU 2018-07, Compensation-Stock Compensation (Topic 718), Improvements to Nonemployee Share-based Payments (“ASU 2018-07”). This ASU expands the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees. The effective date for the standard is for interim periods in fiscal years beginning after December 15, 2018, with early adoption permitted, but no earlier than the Company's adoption date of Topic 606. U nder the new guidance, the measurement of nonemployee equity awards is fixed on the grant date.  The new guidance is required to be applied retrospectively with the cumulative effect recognized at the date of initial application. The Company has adopted this ASU 2018-07 and determined that it does not have a material effect on its financial condition and condensed statements of operations for the three and nine months ended September 30, 2018.

 

In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement. The ASU modifies the disclosure requirements in Topic 820, Fair Value Measurement, by removing certain disclosure requirements related to the fair value hierarchy, modifying existing disclosure requirements related to measurement uncertainty and adding new disclosure requirements, such as disclosing the changes in unrealized gains and losses for the period included in other comprehensive income for recurring Level 3 fair value measurements held at the end of the reporting period and disclosing the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements. This ASU is effective for public companies for annual reporting periods and interim periods within those annual periods beginning after December 15, 2019. The Company is currently evaluating the effect, if any, that the ASU will have on its financial statements.

 

NOTE 2. Property and Equipment

 

The following is a summary of the Company’s property and equipment as of September 30, 2018 and December 31, 2017:

 

    September 30,
2018
    December 31,
2017
 
    (UNAUDITED)        
Laboratory and manufacturing equipment   $ 876,260     $ 829,999  
Office equipment     6,081       6,081  
Leasehold improvements     1,994,585       1,994,585  
Furniture and fixtures     106,510       106,510  
Subtotal     2,983,436       2,937,175  
Less: accumulated depreciation     (2,919,061 )     (2,888,195 )
Property and equipment, net   $ 64,375     $ 37,600  

 

Total depreciation expense was $19,486 and $8,618 for the nine months ended September 30, 2018 and 2017, respectively.

 

10

 

 

NOTE3. Related Party Transactions

 

Operating lease

 

The Company has subleased a portion of its office space to Amkey Ventures, LLC, (the “Amkey”), since June 21, 2001. The sublease is automatically renewed on an annual basis. Amkey is incorporated in the State of California on April 23, 2001. Mr. George J Lee, the Chairman of the Company, is one of managers of Amkey. The sublease is classified as an operating lease and the original lessee shall continue to account for the original lease as it did before commencement of the sublease. Pursuant to ASC 842-20-35-14, the nature of this sublease is such that the original lessee is not relieved of the primary obligation under the original lease, the original lessee (as sublessor) shall continue to account for the original lease.

 

The rental income was $3,600 for the nine months ended September 30, 2018 and 2017. Accordingly, the Company recorded the rental income as a reduction of rent expenses for the nine months ended September 30, 2018 and 2017.

 

Related party sales transaction

 

Genepharm Inc., (the “Genepharm”), was incorporated on March 6, 2000 in the State of California. Mr. George J Lee is the Chairman of both Genepharm and the Company. The Company had net sales of $18,900 and $87,960 to Genepharm for the nine months ended September 30, 2018 and 2017, respectively. As of September 30, 2018 and December 31, 2017, the Company had accounts receivable of $142,225 and $134,312 due from Genepharm, respectively.

 

Due to shareholders

 

The Company has advanced funds from its shareholder and Chairman for working capital purposes. The Company has not entered into any agreement on the repayment terms for these advances. The advances bear no interest rate and are due upon demand by its shareholder and Chairman. During the nine months ended September 30, 2018, the debt of $5,800 was forgiven by its shareholder and Chairman and the Company recorded the debt forgiveness as additional paid in capital. As of September 30, 2018 and December 31, 2017, the outstanding advances were $0 and 5,800, respectively.

 

NOTE4. Accrued Expenses and Other Current Liabilities

 

Accrued expenses and other current liabilities as of September 30, 2018 and December 31, 2017 consisted of:

 

    September 30,
2018
    December 31,
2017
 
    (UNAUDITED)        
Accrued professional fees   $ 37,556     $ 35,756  
Accrued vacation     19,440       19,541  
Others     3,695       2,279  
    $ 60,691     $ 57,576  

 

11

 

 

NOTE 5. Stock-Based Compensation

 

2015 Stock Plan

 

The Company’s board of directors adopted, and its stockholders approved its 2015 Stock Plan (the “2015 Plan”) in March 2015, providing for the issuance under 2015 Plan of options and rights to purchase up to Four million two hundred and fifty thousand (4,250,000) shares of common stock. As of September 30, 2018 and December 31, 2017, there were 308,455 and 918,843 shares available for issuance under the Company’s 2015 Plan, respectively, which provides for the grant of incentive stock options and nonstatutory stock options to employees, directors, and consultants.

 

The exercise price of incentive stock options under the 2015 Plan shall be no less than 100% of the fair market value per share of the common stock on the date of grant. Notwithstanding the above, if an incentive stock option is granted to an employee who owns more than ten percent of the total combined voting power of all classes of stock of the Company or any subsidiary, the exercise price shall be no less than 110% of the fair market value per share of the common stock on the date of grant. The exercise price of nonstatutory stock options under the 2015 Plan shall be no less than 100% of the fair market value per share of the common stock on the date of grant.

 

All stock options under the 2015 Plan have a term of no greater than 10 years from the date of grant. However, in the case of an option granted to an optionee who, at the time the optionee is granted, owns stock representing more than ten percent of the voting power of all classes of stock of the Company or subsidiary, the term of the option shall be 5 years from the date of grant or such shorter term as may be provided in the option agreement.

 

Vesting of stock options is determined by the board of directors of the Company. No stock option may be

 

exercised subsequent to its termination date. The purchase price of a right to purchase common stock and the termination date of the offer under the 2015 Plan is determined by the board of directors of the Company. The Company shall have the right to repurchase all or a portion of the shares acquired pursuant to the exercise of this option in the event that the participant’s continuous service should terminate for any reason whatsoever.

 

The fair value of each stock option granted under 2015 Plan was estimated on the date of grant using the Black-Scholes option pricing model with the following assumptions:

 

Weighted average fair value of common stock on date of grant   $ 0.30  
Weighted average exercise price of the options   $ N/A  
Weighted average exercise price of options outstanding at end of period   $ 0.14  
Expected term of the options (years)     4  
Expected volatility (%)     30 %
Risk-free interest rate(%)     4.0 %
Dividend yield     N/A  
Expected forfeiture per year (%)     3 %
Weighted average fair value of the options per unit   $ 0.30  

 

* No stock options were granted during the three and nine months ended September 30, 2018 and 2017

 

Compensation expense related to stock-based transactions is measured and recognized in the financial statements based on the fair value of the awards granted. The stock-based compensation expense, net of forfeitures, is recognized on a straight-line basis over the requisite service periods of the awards, which is generally three to four years.

 

Use of the Black-Scholes option pricing model requires the input of subjective assumptions, including the fair value of the underlying common stock, expected term of the option, expected volatility of the price of the common stock, risk-free interest rates, and expected dividend yield of the common stock. The assumptions used in the option-pricing model represent management’s best estimates.

 

These assumptions and estimates are as follows:

 

Fair Value of Common Stock

 

The fair value of the common stock underlying its stock-based awards was primarily based on the latest financing rounds of issuing equity interest near the option grant date. It was determined by the Company’s board of directors, with input from management and a third-party valuation firm.

 

Expected Term

 

The expected term assumptions were determined based on the vesting terms, exercise terms, and contractual lives of the options.

 

12

 

 

Expected Volatility

 

The expected volatility of stock options is estimated based upon the historical volatility of a number of publicly traded companies in similar stages of development and comparable industries for a period commensurate with the expected life.

 

Risk-Free Interest Rate

 

The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the time of grant for zero-coupon U.S. Treasury notes with maturities approximately equal to the option’s expected term.

 

Dividend Yield

 

The Company has never declared or paid any cash dividends and does not presently plan to pay cash dividends in the foreseeable future. Consequently, an expected dividend yield of zero was utilized.

 

Expected Forfeitures

 

The Company considers many factors when estimating expected forfeitures, including economic environment, and historical experience. The Company updates its estimated forfeiture rate annually.

 

The following table summarizes the stock option activity under the 2015 Plan and related information:

 

Options Outstanding
    Number of           Weighted-  
    Shares           Average  
    Underlying     Weighted-     Remaining  
    Outstanding     Average     Contractual  
    Options     Exercise Price     Life (Years)  
Outstanding – January 1, 2016     49,767       0.23       6.46  
Granted     -       N/A       -  
Exercised     -       N/A       -  
Forfeited or cancelled     (4,000 )     N/A       -  
Outstanding – December 31, 2016     45,767       0.24       5.97  
Granted     -       N/A       -  
Exercised     -       N/A       -  
Forfeited or cancelled     (32,356 )     N/A       -  
Outstanding – December 31, 2017     13,411       0.25       5.72  
Granted     -       N/A       -  
Exercised     -       N/A       -  
Forfeited or cancelled     -       N/A       -  
Outstanding – September 30, 2018     13,411       0.25       5.22  
                         
Exercisable – December 31, 2017     13,411     $ 0.25       5.72  
                         
Vested and expected to vest – December 31, 2017     13,411     $ 0.25       5.72  
                         
Exercisable – September 30, 2108     13,411     $ 0.25       4.97  
                         
Vested and expected to vest – September 30, 2018     13,411     $ 0.25       4.97  

 

The weighted-average grant-date fair value of options granted during the nine months ended September 30, 2018 and during the year ended December 31, 2017 was $0.25 per share. The total fair value of options vested during the nine months ended September 30, 2018 and 2017 was $0.

 

NOTE 6. Operating Lease Obligation

 

The Company leases its main office in Fremont, California, under operating leases expiring on February 28, 2021. The monthly rent is approximately $23,600. The Company also leases an office equipment with monthly payment of approximately $220 expiring on August 31, 2019. The total rent expenses were $205,576 and $205,278 for the nine months ended September 30, 2018 and 2017, respectively.

 

13

 

 

Future minimum lease payments under the Company’s operating leases are as follows:

 

As of September 30,   Amount  
2019   $ 239,422  
2020     236,951  
2021     98,730  
Total   $ 575,103  

 

NOTE 7. Income Taxes

 

The Company files income tax returns in the U.S. federal jurisdiction, and various state and local jurisdictions. The Company is no longer subject to U.S. federal, state and local income tax examinations by tax authorities for years before 2013.

 

On  December 22, 2017  H.R 1,  originally known as the Tax Cuts and Jobs Act, (the “Tax Act”) was enacted. Among the significant changes to the U.S. Internal Revenue Code, the Tax Act lowers the U.S. federal corporate income tax rate (“Federal Tax Rate”) from  35%  to  21%  effective January 1, 2018.  The  21%  Federal Tax Rate is applied to earnings reported for the full  2018   fiscal year. In addition, the Company must re-measure its net deferred tax assets and liabilities using the Federal Tax Rate that will apply when these amounts are expected to reverse. As of September 30, 2018 and December 31, 2017, the Company can determine a reasonable estimate for certain effects of tax reform and is recording that estimate as a provisional amount. The provisional remeasurement of the deferred tax assets and allowance valuation of deferred tax assets at December 31, 2017 resulted in a net effect of $0 discrete tax expenses (benefit) which lowered the effective tax rate by 14% for the year ended December 31, 2017.

 

The provisional remeasurement amount is anticipated to change as data becomes available allowing more accurate scheduling of the deferred tax assets and liabilities primarily related to net operating loss carryover.

 

Components of income tax (benefits) for the nine months ended September 30, 2018 and 2017 are as follows:

 

    Nine months ended September 30, 2018     Nine months September 30, 2017  
    Federal     State     Total     Federal     State     Total  
Current   $             -     $ 800     $ 800     $             -     $ 800     $ 800  
Deferred     -       -       -       -       -       -  
    $ -     $ 800     $ 800     $ -     $ 800     $ 800  

 

Significant components of the Company’s deferred tax accounts at September 30, 2018 and December 31, 2017:

 

Deferred tax account - noncurrent:   September 30,
2018
    December 31,
2017
 
    (UNAUDITED)        
Allowance for doubtful accounts   $ 20,849     $ 20,846  
Reserve for obsolete inventory     177       177  
Accrued vacation     5,441       5,468  
Accumulated depreciation     (2,263 )     (2,703 )
Tax net operating loss carry forwards     3,764,544       3,740,797  
General business credit     1,285,104       1,316,980  
Less: Valuation allowance     (5,073,852 )     (5,081,565 )
Total deferred tax account - noncurrent   $ -     $ -  

 

The difference between the effective rate reflected in the provision for income taxes on loss before taxes and the amounts determined by applying the applicable statutory U.S. tax rate for the nine months ended September 30, 2018 and 2017 are analyzed below:

 

    2018     2017  
Statutory tax benefit, net of state effects     19 %     31 %
State income taxes     8.84 %     8.84 %
Nondeductible/nontaxable items     - %     - %
Change in valuation allowance     (27.84 )%     (39.84 )%
Effective income tax rate     - %     - %

 

NOTE 8. Subsequent Events

 

The Company has evaluated subsequent events through the date which the financial statements were available to be issued. All subsequent events requiring recognition as of September 30, 2018 have been incorporated into these financial statements and there are no subsequent events that require disclosure in accordance with FASB ASC Topic 855, “Subsequent Events.”

 

******

 

14

 

 

Exhibit 99.5

 

AMERICAN BRIVISION (HOLDING) CORPORATION AND SUBSIDIARIES

UNAUDITED CONDENSED CONSOLIDATED COMBINED

PRO FORMA FINANCIAL INFORMATION

 

Introduction

 

On January 31, 2018, American BriVision (Holding) Corporation (“ABVC”, the “Company”) entered into an agreement and plan of merger (the “Merger Agreement”) with BioLite Holding, Inc. (“BioLite”), a Nevada corporation, BioKey, Inc. (“BioKey”), a California corporation, BioLite Acquisition Corp. (“Merger Sub 1”), a Nevada corporation and wholly-owned subsidiary of the Company, and BioKey Acquisition Corp. (“Merger Sub 2”), a California corporation and wholly-owned subsidiary of the Company.

 

Pursuant to the Merger Agreement, on or before the Closing of the Merger, each issued and outstanding share of BioLite shall be converted into the right to receive one point eighty-two (1.82) validly issued, fully-paid and non-assessable shares of the Company and all shares of BioLite shall be cancelled and cease to exist. Also on or before the Closing of the Merger, each issued and outstanding share of BioKey shall be converted into the right to receive one (1) validly issued, fully-paid and non-assessable share of the Company and all shares of BioKey shall be cancelled and cease to exist. Simultaneously upon Closing, BioLite and Merger Sub 1 shall merge together with Merger Sub 1’s articles of incorporation and bylaws as the surviving corporation’s (the “BioLite Surviving Corporation”) articles of incorporation and bylaws and all shares of Merger Sub 1 shall be converted into one share of Common Stock of the BioLite Surviving Corporation, which shall remain a wholly-owned subsidiary of the Company. In addition, upon Closing, BioKey and Merger Sub 2 shall merge together with Merger Sub 2’s articles of incorporation and bylaws as the surviving corporation’s (the “BioKey Surviving Corporation’s”) articles of incorporation and bylaws and all shares of Merger Sub 2 shall be converted into one share of Common Stock of the BioKey Surviving Corporation, which shall remain a wholly-owned subsidiary of the Company.

 

The following unaudited pro forma condensed consolidated combined financial statements reflect the combination of the historical consolidated results of ABVC and its subsidiaries, BioLite, and BioKey on a pro forma basis to give effect to the Merger Agreement.

 

The unaudited pro forma condensed consolidated combined balance sheet of the combined company is based on (i) the audited historical consolidated balance sheet of ABVC as of December 31, 2017, (ii) the audited historical balance sheet of BioLite as of December 31, 2017, and the (iii) the audited historical balance sheet of BioKey as of December 31, 2017, and includes pro forma adjustments as of the Merger had occurred on December 31, 2017.

 

The unaudited pro forma condensed consolidated combined statement of operations of the combined company are based on the following details, and includes pro forma adjustments as of the Merger had occurred on January 1, 2017.

 

  (i) the unaudited historical consolidated statement of operations of ABVC for the twelve months ended December 31, 2017. On February 14, 2018, the Board of Directors of ABVC approved a change in the Company’s fiscal year from September 30 to December 31, effective immediately. As a result of this change, on April 13, 2018, the Company filed a Transition Report on Form 10-K for the three-month period ended December 31, 2017. After a change in fiscal year end in which the transition report has been filed on Form 10-K on April 13, 2018, ABVC determined to present pro forma information for the transition period  and  most recent fiscal year (and interim period). Because the transition period is only three months, the period from January 1, 2017 to September 30, 2017 is added to the transition period to comply with S-X Rule 3-06.
     
  (ii) the audited historical statement of operations of BioLite for the twelve months ended December 31, 2017.
     
  (iii) the audited historical statement of operations of BioKey for the twelve months ended December 31, 2017.

 

 

 

 

The unaudited pro forma data presented herein reflects events that are directly attributable to the described transactions, factually supportable, and as it relates to the unaudited pro forma condensed consolidated combined statement of operations, expected to have a continuing impact. The unaudited pro forma data presented herein also reflects certain assumptions which management believes are reasonable. Such pro forma data is not necessarily indicative of financial results that would have been attained had the described transactions occurred on the dates indicated above, or the results of the combined company that may be achieved in the future. The adjustments are based on currently available information and certain estimates and assumptions. Therefore, the actual results may differ from the pro forma results indicated herein. However, management believes that the assumptions provide a reasonable basis for presenting the significant effects of the transactions as contemplated and that the pro forma adjustments give appropriate effect to those assumptions and are properly applied in the unaudited pro forma condensed consolidated combined financial statements.

 

The unaudited pro forma condensed consolidated combined financial statements are provided for illustrative purposes only and are not intended to represent or be indicative of the consolidated results of operations or consolidated financial position of the combined company that would have been recorded had the Merger been completed as of the dates presented, and they should not be taken as representative of the expected future results of operations or financial position of the combined company. The unaudited pro forma condensed consolidated combined financial statements do not reflect the impacts of any potential operational efficiencies, asset dispositions, cost savings or economies of scale that the combined company may achieve with respect to the operations of the combined company. Additionally, the unaudited pro forma condensed consolidated combined statement of operations does not include non-recurring charges or credits, and the related tax effects, which result directly from the Merger.

 

The unaudited pro forma condensed consolidated combined financial statements have been derived from, and should be read in conjunction with, (i) the historical consolidated financial statements and accompanying notes of ABVC, as included in ABVC’s transition report filed on Form 10-KT for the three months ended December 31, 2017 on April 13, 2018, (ii) the historical consolidated financial statements and accompanying notes of ABVC, as included in ABVC’s Annual Report on Form 10-K for the year ended September 30, 2017 filed with the SEC on January 16, 2018 and (iii) the historical financial statements and accompanying notes of BioLite and BioKey, as included in this prospectus report.

  

2

 

 

UNAUDITED PRO FORMA CONDENSED CONSOLIDATED COMBINED BALANCE SHEET

AS OF DECEMBER 31, 2017

  

                      Pro Forma         Pro Forma  
    ABVC     BioKey     BioLite     Adjustment     Note   Combined  
ASSETS                                  
Current Assets                                  
Cash and cash equivalents   $ 93,332     $ 1,225,397     $ 256,925                 $ 1,575,654  
Accounts receivable, net     -       59,080       -                   59,080  
Accounts receivable - related parties, net     -       134,312       3,475                   137,787  
Receivable from collaboration partners – related parties     2,550,000       -       -                   2,550,000  
Due from related parties     -       -       153,953       (109,220 )   {f}     44,733  
Inventory     -       -       199,708                   199,708  
Prepaid expense and other current assets     -       -       146,912                   146,912  
Total Current Assets     2,643,332       1,418,789       760,973       (109,220 )         4,713,874  
                                             
Property and equipment, net     -       37,600       570,576                   608,176  
Goodwill, net                             52,728,835     {e}     52,728,835  
Long-term investments     -       -       4,185,969                   4,185,969  
Deferred tax assets     -       -       1,017,897                   1,017,897  
Security Deposits     -       10,440       68,876                   79,316  
Total Assets   $ 2,643,332     $ 1,466,829     $ 6,604,291     $ 52,619,615         $ 63,334,067  
                                             
LIABILITIES AND EQUITY                                            
Current Liabilities                                            
Short-term bank loan     -       -       927,800                   927,800  
Long-term bank loan - current portion     -       -       40,203                   40,203  
Notes payable     -       -       202,429                   202,429  
Accrued expenses and other current liabilities     170,927       73,957       527,500                   772,384  
Due to related parties     4,229,320       5,800       2,390,498       (109,220 )   {f}     6,516,398  
Total Current Liabilities     4,400,247       79,757       4,088,430       (109,220 )         8,459,214  
                                             
Long-term bank loan     -       -       55,690                   55,690  
Tenant security deposit     -       2,880       -                   2,880  
Total Liabilities     4,400,247       82,637       4,144,120       (109,220 )         8,517,784  
                                             
Equity                                            
Preferred Stock     -       18,633,097       -       (18,633,097 )   {c}     -  
Common Stock     213,747       541,793       4,121       (4,121 )   {a}     317,376  
                              74,998     {a}        
                              (541,793 )   {b}        
                              6,498     {b}        
                              22,133     {c}        
Additional paid-in capital     13,805,936       296,465       10,862,995       (70,877 )   {a}     68,682,449  
                              (296,465 )   {b}        
                              54,084,395     {e}        
                              (10,000,000 )   {g}        
Accumulated deficit     (15,776,598 )     (18,087,163 )     (9,971,033 )     18,087,163     {b}     (6,765,087 )
                              8,982,544     {a}        
                              10,000,000     {g}        
Other comprehensive income     -       -       757,327       117,457      {a}     874,784  
Treasury Stock     -       -       -       (6,750,000 )   {g}     (9,100,000 )
                              (2,350,000 )   {h}        
Total Stockholders’ deficit     (1,756,915 )     1,384,192       1,653,410       52,728,835           54,009,522  
Noncontrolling Interest     -       -       806,761                   806,761  
Total Equity     (1,756,915 )     1,384,192       2,460,171       52,728,835           54,816,283  
                                             
Total Liabilities and Equity   $ 2,643,332     $ 1,466,829     $ 6,604,291     $ 52,619,615         $ 63,334,067  

 

3

 

 

UNAUDITED PRO FORMA CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

FOR THE TWELVE MONTHS ENDED DECEMBER 31, 2017

 

                      Pro Forma         Pro Forma      
    ABVC     BioKey     BioLite     Adjustment     Note   Combined      
                                       
Revenues   $ -     $ 983,218     $ 3,196                 $ 986,414      
                                                 
Cost of revenues     -       17,312       2,249                   19,561      
                                                 
Gross profit     -       965,906       947                   966,853      
                                                 
Operating expenses                                                
Selling, general and administrative expenses     811,685       767,504       1,735,931                   3,315,120      
Research and development expenses     3,171,665       497,947       256,682                   3,926,294      
Stock based compensation     155,400       -       -                   155,400      
Total operating expenses     4,138,750       1,265,451       1,992,613                   7,396,814      
                                                 
Loss from operations     (4,138,750 )     (299,545 )     (1,991,666 )                 (6,429,961 )    
                                                 
Other income (expense)                                                
Interest income     180       6,742       7,207                   14,129      
Interest expense     (103,460 )             (222,060 )                 (325,520 )    
Rental income                     11,814                   11,814      
Investment loss                     (34,139 )                 (34,139 )    
Gain/Loss on foreign exchange changes                     (409,170 )                 (409,170 )    
Gain/Loss on investment in equity securities                     (4,443,876 )     4,313,725           (130,151 )    
Other income (expense)     -       459       51,574                   52,033      
Total other income (expenses)     (103,280 )     7,201       (5,038,650 )     4,313,725           (821,044 )    
                                                 
Loss before provision for income tax     (4,242,030 )     (292,344 )     (7,030,316 )     4,313,725           (7,250,965 )    
                                                 
Provision for income tax (benefit)     830       800       (360,395 )                 (358,765 )    
                                                 
Net loss     (4,242,860 )     (293,144 )     (6,669,921 )     4,313,725           (6,892,200 )    
                                                 
Net loss attributable to noncontrolling interests     -       -       (1,621,650 )                 (1,621,650 )    
                                                 
Net loss attributable to ABVC and subsidiaries     (4,242,860 )     (293,144 )     (5,048,271 )     4,313,725           (5,270,550 )    
Foreign currency translation adjustment     -       -       695,573                   695,573      
Comprehensive Income (Loss)   $ (4,242,860 )   $ (293,144 )   $ (4,352,698 )     4,313,725         $ (4,574,977 )    
                                                 
Net loss per share attributable to Common Stockholders                                                
Basic and diluted   $ (0.02 )                               $ (0.02 )    
Weighted average number of common shares outstanding                                                
Basic and diluted     213,386,031                                   312,419,426     {d}

 

4

 

  

Notes to the Unaudited Pro Forma Condensed Consolidated Combined Financial Statements
For the Twelve Months Ended December 31, 2017

 

1. Basis of Presentation

 

The unaudited pro forma condensed consolidated combined balance sheet as of December 31, 2017 is based on the audited consolidated balance sheet of ABVC, the audited balance sheet of BioLite, and the audited balance sheet of BioKey as if the Merger had occurred on December 31, 2017.

 

On February 14, 2018, the Board of Directors of ABVC approved a change in the Company’s fiscal year from September 30 to December 31, effective immediately. As a result of this change, on April 13, 2018, the Company filed a Transition Report on Form 10-K for the three-month period ended December 31, 2017. After a change in fiscal year end in which the transition report has been filed on Form 10-K on April 13, 2018, ABVC determined to present pro forma information for the transition period  and  most recent fiscal year (and interim period). Because the transition period is only three months, the period from January 1 to September 30, 2017 is added to the transition period to comply with S-X Rule 3-06.

 

As such, the unaudited pro forma condensed consolidated combined statement of operations for the twelve months ended December 31, 2017 is based on the audited statement of operations of ABVC for the twelve months ended December 31, 2017, the audited historical statement of operations of BioLite for the twelve months ended December 31, 2017, and the audited historical statement of operations of BioKey for the twelve months ended December 31, 2017, as if the Merger had occurred on January 1, 2017.

 

BioLite and the Company are related parties because the two companies are under common control by Dr. Tsung-Shann Jiang.

 

2. Pro Forma Adjustments

 

The following adjustments were made in the preparation of the unaudited pro forma condensed consolidated combined balance sheet and unaudited pro forma condensed consolidated combined statements of operations:

 

{a} Reconciliation of ABVC Common Stock to be issued to BioLite shareholders:

 

BioLite Outstanding shares as of 12/31/2017     41,207,444  
Exchange of each BioLite share of Common Stock outstanding as of December 31, 2017, for 1.82 shares of ABVC Common Stock     1.82  
ABVC Common Stock to be issued to BioLite as a result of the Merger     74,997,548  
Par value $0.001 per share of ABVC   $ 74,998  

 

{b} ABVC Common Stock to be issued to BioKey shareholders in exchange of BioKey’s Common Stock outstanding:

 

BioKey Outstanding shares as of 12/31/2017     6,498,134  
Exchange of each BioKey share of Common Stock outstanding as of December 31, 2017, for one share of ABVC Common Stock     1  
ABVC Common Stock to be issued to BioKey as a result of the Merger     6,498,134  
Par value $0.001 per share of ABVC   $ 6,498  

 

{c} ABVC Common Stock to be issued to BioKey shareholders in exchange of BioKey’s preferred stock outstanding:

 

BioKey Outstanding shares as of 12/31/2017      
7,000,000 shares of Series A     7,000,000  
1,160,000 shares of Series A     1,160,000  
13,973,097 shares of Series C     13,973,097  
BioKey’s total shares of preferred stock outstanding as of 12/31/2017     22,133,097  
Exchange of each BioKey share of preferred stock outstanding as of December 31, 2017, for one share of ABVC Common Stock     1  
ABVC Common Stock to be issued to BioKey as a result of the Merger     22,133,097  
Par value $0.001 per share of ABVC   $ 22,133  

 

5

 

 

{d} Common Stock outstanding as of December 31, 2017 following the Merger:

 

ABVC Common Stock issued as of December 31, 2017     213,746,647  
ABVC Common Stock held by BioLite pursuant to the BioLite Collaborative Agreement (see Note {g})     (3,487,500 )
ABVC Common Stock held by BioLite for cash issuance (see Note {h})     (1,468,750 )
ABVC Common Stock to be issued to BioLite as a result of the Merger     74,997,548  
ABVC Common Stock to be issued to BioKey as a result of the Merger     28,631,231  
Total Common Stock of the combined company outstanding following the Merger     312,419,176  

  

{e} Unless otherwise noted, adjustments to reflect the elimination of BioKey’s total equity, the estimated value of consideration to be paid in the Merger and to adjust, where required, the historical carrying values of BioKey’s assets and liabilities as of December 31, 2017 to the preliminary estimated fair value, in accordance with the acquisition method of accounting. The preliminary valuations were determined as of and, where applicable, are based on the bid-and-ask share price of ABVC Common Stock on the final day of trading, May 23, 2018 The fair value of the consideration given and assets and liabilities acquired will be determined based on the underlying fair values as of the May 23, 2018.

 

Purchase consideration:      
Common Stock (1)   $ 54,113,027  
Estimated Fair Value of Assets Acquired:        
Cash and cash equivalents   $ 1,225,397  
Accounts Receivable     59,080  
Accounts Receivable - related parties     134,312  
Property and equipment     37,600  
Security Deposits     10,440  
Total assets acquired     1,466,829  
Estimated Fair Value of Liabilities Assumed:        
Accounts payable     5,396  
Due to shareholders     5,800  
Accrued expenses and other current liabilities     57,576  
Advance from customers     10,985  
Tenant security deposit     2,880  
Total liabilities assumed     82,637  
Total net assets acquired     1,384,192  
Goodwill as a result of the Merger   $ 52,728,835  

 

(1) 28,631,231 shares of ABVC Common Stock to be issued to BioKey in connection with the Merger. Those shares were valued at $1.89 per share, the closing share price of ABVC on May 23, 2018.

  

{f} As of December 31, 2017, ABVC had $109,220 due to BioLite.

  

6

 

 

{g} Collaborative agreement with BioLite Inc., a related party

  

On December 29, 2015, American BriVision Corporation (“BriVision”) entered into a collaborative agreement (the “BioLite Collaborative Agreement”) with BioLite, a related party, pursuant to which BioLite granted BriVision sole licensing rights for drug and therapeutic use of five products, including BLI-1005 CNS-Major Depressive Disorder, BLI-1008 CNS-Attention Deficit Hyperactivity Disorder, BLI-1401-1 Anti-Tumor Combination Therapy-Solid Tumor with Anti-PD-1, BLI-1401-2 Anti-Tumor Combination Therapy-Triple Negative Breast Cancer, and BLI-1501 Hematology-Chronic Lymphocytic Leukemia, in the U.S.A and Canada. Under the BioLite Collaborative Agreement, BriVision should pay a total of $100,000,000 in cash or stock of BriVision with equivalent value, according to the following schedule:

 

  upfront payment shall upon the signing of this BioLite Collaborative Agreement: 3.5% of total payment. After receiving upfront payment from BriVision, BioLite has to deliver all data to BriVision in one week.

 

  upon the first IND submission, BriVision shall pay, but no later than December 15, 2016: 6.5% of total payment. After receiving second payment from BriVision, BioLite has to deliver IND package to BriVision in one week.
     
  at the completion of first phase II clinical trial, BriVision shall pay, but no later than September 15, 2017: 15% of total payment. After receiving third payment from BriVision, BioLite has to deliver phase II clinical study report to BriVision in three months.
     
  upon the phase III IND submission, BriVision shall pay, but no later than December 15, 2018: 20% of total payment. After receiving forth payment from BriVision, BioLite has to deliver IND package to BriVision in one week.
     
  at the completion of phase III, BriVision shall pay, but no later than September 15, 2019:25% of total payment. After receiving fifth payment from BriVision, BioLite has to deliver phase III clinical study report to BriVision in three months.
     
  upon the NDA submission, BriVision shall pay, but no later than December 15, 2020, BriVision shall pay: 30% of total payment. After receiving sixth payment from BriVision, BioLite has to deliver NDA package to BriVision in one week. 

 

This BioLite Collaborative Agreement shall, once signed by both Parties, remain in effect for fifteen years as of the first commercial sales of the Product in the Territory and automatically renew for five more years unless either party gives the other party six month written notice of termination prior to the expiration date of the term.

 

Pursuant to the BioLite Collaborative Agreement, an upfront payment of $3,500,000 (the “Milestone Payment”), which is 3.5% of total payments due under the BioLite Collaborative Agreement, was to be paid by BriVision upon signing of that agreement. On May 6, 2016, BriVision and BioLite agreed to amend the BioLite Collaborative Agreement, through entry into the Milestone Payment Agreement, whereby BriVision agreed to pay the Milestone Payment to BioLite with $2,600,000 in cash and $900,000 in the form of newly issued shares of its Common Stock, at the price of $1.60 per share, for an aggregate number of 562,500 shares. The cash payment and shares issuance were completed in June 2016.

 

7

 

 

Pursuant to the BioLite Collaborative Agreement, the 6.5% of total payment, $6,500,000 shall be made upon the first IND submission which was submitted in March 2016. On February 2017, BriVision agreed to pay this amount to BioLite with $650,000 in cash and $5,850,000 in the form of newly issued shares of its Common Stock, at the price of $2.0 per share, for an aggregate number of 2,925,000 shares. The cash payment and shares issuance were completed in February 2017.

 

Pursuant to the BioLite Collaborative Agreement, the 15% of total payment, $15,000,000 shall be made at the completion of first phase II clinical trial. As of December 31, 2017, the first phase II clinical trial research has not completed yet.

 

The aggregate Common Stock shares of American BriVision Corporation issued to BioLite pursuant to the BioLite Collaborative Agreement was 3,487,500 shares, the value of which was $6,750,000. The unaudited pro forma adjustments were made as if the Merger occurred on December 31, 2017. As such, these Common Stock shares of ABVC held by BioLite shall be treated not be treated as outstanding shares, and shall be reflected as treasury shares.

 

American BriVision Corporation determined to fully expense the entire amount of $10,000,000 according to ASC 730-10-25-1. The entire amount is fully expensed as research and development expense during the twelve months ended December 31, 2016.

 

During the year ended December 31, 2017, BioLite recognized loss on investment in ABVC’s equity securities of $4,313,725. The amount has been eliminated in the pro forma condensed consolidated statement of operations.

 

{h} On August 26, 2016, ABVC issued 1,468,750 shares of Common Stock, par value $0.001 to BioLite pursuant to a certain Stock Purchase Agreement dated August 26, 2016. The purchase price per share of the Offering is $1.60. The net proceeds to the Company from the Offering are approximately $2,350,000.  The unaudited pro forma adjustments were made as if the Merger occurred on December 31, 2017. As such, these Common Stock shares of ABVC held by BioLite shall be treated not be treated as outstanding shares, and shall be reflected as treasury shares.

 

8

 

  

AMERICAN BRIVISION (HOLDING) CORPORATION AND SUBSIDIARIES

UNAUDITED CONDENSED CONSOLIDATED COMBINED

PRO FORMA FINANCIAL INFORMATION AS OF SEPTEMBER 30, 2018

 

UNAUDITED PRO FORMA CONDENSED CONSOLIDATED COMBINED BALANCE SHEET

AS OF SEPTEMBER 30, 2018

 

                      Pro Forma         Pro Forma  
    ABVC     BioKey     BioLite     Adjustment     Note   Combined  
ASSETS                                  
Current Assets                                  
Cash and cash equivalents   $ 4,389     $ 733,843     $ 183,353                 $ 921,585  
Accounts receivable, net             83,479       2,050                   85,529  
Accounts receivable - related parties, net     2,550,000       142,225       656                   142,881  
Receivable from collaboration partners – related parties                                         2,550,000  
Due from related parties     40,000               129,567       (22,009 )   {f}     147,558  
Inventory                     183,065                   183,065  
Prepaid expense and other current assets                     185,252                   185,252  
Total Current Assets     2,594,389       959,547       683,943       (22,009 )         4,215,870  
Property and equipment, net             64,375       522,067                   586,442  
Goodwill, net                             55,200,837     {e}     55,200,837  
Long-term investments                     3,316,878                   3,316,878  
Deferred tax assets                     1,227,334                   1,227,334  
Security Deposits             10,440       47,280                   57,720  
Total Assets   $ 2,594,389     $ 1,034,362     $ 5,797,502     $ 55,178,828         $ 64,605,081  
                                             
LIABILITIES AND EQUITY                                            
Current Liabilities                                            
Short-term bank loan                     656,000                   656,000  
Long-term bank loan - current portion                     39,737                   39,737  
Notes payable                     497,248                   497,248  
Accrued expenses and other current liabilities     436,828       84,980       785,057                   1,306,865  
Due to related parties     4,041,703               2,757,064       (21,603 )   {f}     6,777,164  
Total Current Liabilities     4,478,531       84,980       4,735,106       (21,603 )         9,277,014  
                                             
Long-term bank loan                     25,092                   25,092  
Tenant security deposit             2,880                           2,880  
Convertible notes payable     300,000                                   300,000  
Convertible notes payable - related parties     250,000                                   250,000  
Accrued interest     14,567                                   14,567  
                                             
Total Liabilities     5,043,098       87,860       4,760,198       (21,603 )         9,869,553  
Equity                                            
Preferred stock             18,633,097               (18,633,097 )   {c}        
Common stock     213,927       771,793       4,121       (4,121 )   {a}     318,476  
                              74,998     {a}        
                              (771,793 )   {b}        
                              7,418     {b}        
                              22,133     {c}        
Additional paid-in capital     13,909,157       82,265       10,862,995       (70,877 )   {a}     70,819,063  
                              (82,265 )   {e}        
                              56,117,788     {e}        
                              (10,000,000 )   {g}        
Accumulated deficit     (16,571,793 )     (18,540,653 )     (10,980,204 )     18,540,653     {e}     (8,438,433 )
                              6,817,848     {g}        
                              2,295,716     {h}        
                              10,000,000     {g}        
Other comprehensive income                     676,227       (13,970 )   {f,g}     662,257  
Treasury stock                             (6,750,000 )   {g}     (9,100,000 )
                              (2,350,000 )   {h}        
Total Stockholders’ deficit     (2,448,709 )     946,502       563,139       55,200,431           54,261,363  
Noncontrolling interest                     474,165                   474,165  
Total Equity     (2,448,709 )     946,502       1,037,304       55,200,431           54,261,363  
Total Liabilities and Equity   $ 2,594,389     $ 1,034,362     $ 5,797,502     $ 55,178,828         $ 64,605,081  

  

9

 

  

UNAUDITED PRO FORMA CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2018

 

                      Pro Forma         Pro Forma      
    ABVC     BioKey     BioLite     Adjustment     Note   Combined      
                                       
Revenues   $ 0     $ 382,097     $ 3,976                     $ 386,073      
                                                 
Cost of revenues             3,215       2,856                   6,071      
                                                 
Gross profit             378,882       1,120                   380,002      
                                                 
Operating expenses                                                
Selling, general and administrative expenses     520,256       498,396       693,057                   1,711,709      
Research and development expenses     135,006       337,810       224,316                   697,132      
Stock based compensation     23,401                                   23,401      
Total operating expenses     678,663       836,206       917,373                   2,432,242      
                                                 
Loss from operations     (678,663 )     (457,324 )     (916,253 )                 (2,052,240 )    
                                                 
Other income (expense)                                                
Interest income             4,144       3,761                   7,905      
Interest expense     (114,682 )             (231,300 )                 (345,982 )    
Rental income                     8,997                   8,997      
Investment loss                     (287,513 )                 (287,513 )    
Gain/Loss on foreign exchange  changes                     7,403                   7,403      
Gain/Loss on investment in equity securities                     (164,649 )                 (164,649 )    
Other income (expense)             490       (4,305 )                 (3,815 )    
Total other income (expenses)     (114,682 )     4,634       (667,606 )                 (777,654 )    
                                                 
Loss before provision for income tax     (793,682 )     (452,690 )     (1,583,859 )                 (2,829,894 )    
                                                 
Provision for income tax (benefit)     1,850       800       (242,092 )                 (239,442 )    
                                                 
Net loss     (795,195 )     (453,490 )     (1,341,767 )                 (2,590,452 )    
                                                 
Net loss attributable to noncontrolling interests                     (332,596 )                 (332,596 )    
                                                 
Net loss attributable to ABVC and subsidiaries     (795,195 )     (453,490 )     (1,009,171 )                 (2,257,856 )    
Foreign currency translation adjustment                     (81,100 )                 (81,100 )    
Comprehensive Income (Loss)   $ (795,195 )   $ (453,490 )   $ (1,090,271 )               $ (2,338,956 )    
                                                 
Net loss per share attributable to common stockholders                                                
Basic and diluted   $ (0.00 )                               $ (0.01 )    
Weighted average number of common shares outstanding                                                
Basic and diluted     213,869,286                                   312,639,004     {d}

 

10

 

 

Notes to the Unaudited Pro Forma Condensed Consolidated Combined Financial Statements

 

1. Basis of Presentation

 

The unaudited pro forma condensed consolidated combined balance sheet as of September 30, 2018 is based on the unaudited consolidated balance sheet of ABVC, the unaudited consolidated balance sheet of BioLite, and the unaudited balance sheet of BioKey as if the Merger had occurred on September 30, 2018.

 

The unaudited pro forma condensed consolidated combined statement of operations for the nine months ended September 30, 2018 is based on the unaudited consolidated statement of operations of ABVC for the nine months ended September 30, 2018, the unaudited consolidated statement of operations of BioLite for the nine months ended September 30, 2018, and the unaudited statement of operations of BioKey for the nine months ended September 30, 2018, as if the Merger had occurred on January 1, 2018.

 

On February 14, 2018, the Board of Directors of ABVC approved a change in the Company’s fiscal year from September 30 to December 31, effective immediately. As a result of this change, on April 13, 2018, the Company filed a Transition Report on Form 10-K for the three-month period ended December 31, 2017. After a change in fiscal year end in which the transition report has been filed on Form 10-K on April 13, 2018, ABVC determined to present pro forma information for the transition period and most recent fiscal year (and interim period). Because the transition period is only three months, the period from January 1 to September 30, 2017 is added to the transition period to comply with S-X Rule 3-06.

 

As such, the unaudited pro forma condensed consolidated combined statement of operations for the twelve months ended December 31, 2017 is based on the audited consolidated statement of operations of ABVC for the twelve months ended December 31, 2017, the audited consolidated statement of operations of BioLite for the twelve months ended December 31, 2017, and the audited statement of operations of BioKey for the twelve months ended December 31, 2017, as if the Merger had occurred on January 1, 2017.

 

BioLite and the Company are related parties because the two companies are under common control by Dr. Tsung-Shann Jiang.

  

2. Pro Forma Adjustments

 

The following adjustments were made in the preparation of the unaudited pro forma condensed consolidated combined balance sheet and unaudited pro forma condensed consolidated combined statements of operations:

 

{a} Reconciliation of ABVC common stock to be issued to BioLite shareholders:

 

BioLite Outstanding shares as of September 30, 2018     41,207,444  
Exchange of each BioLite share of common stock outstanding as of September 30, 2018, for 1.82 shares of ABVC common stock     1.82  
ABVC common stock to be issued to BioLite as a result of the Merger     74,997,548  
Par value $0.001 per share of ABVC   $ 74,998  

  

{b} ABVC common stock to be issued to BioKey shareholders in exchange of BioKey’s common stock outstanding:

 

BioKey Outstanding shares as of September 30, 2018     7,418,134  
Exchange of each BioKey share of common stock outstanding as of September 30, 2018, for one share of ABVC common stock     1  
ABVC common stock to be issued to BioKey as a result of the Merger     7,418,134  
Par value $0.001 per share of ABVC   $ 7,418  

  

11

 

 

{c} ABVC common stock to be issued to BioKey shareholders in exchange of BioKey’s preferred stock outstanding:

 

BioKey Outstanding shares as of September 30, 2018      
7,000,000 shares of Series A     7,000,000  
1,160,000 shares of Series A     1,160,000  
13,973,097 shares of Series C     13,973,097  
BioKey’s total shares of preferred stock outstanding as of September 30, 2018     22,133,097  
Exchange of each BioKey share of preferred stock outstanding as of September 30, 2018, for one share of ABVC common stock     1  
ABVC common stock to be issued to BioKey as a result of the Merger     22,133,097  
Par value $0.001 per share of ABVC   $ 22,133  

 

{d} Common stock outstanding as of September 30, 2018 following the Merger:

 

ABVC common stock issued as of September 30, 2018     213,926,475  
ABVC common stock held by BioLite pursuant to the BioLite Collaborative Agreement (see Note {g})     (3,487,500 )
ABVC common stock held by BioLite for cash issuance (see Note {h})     (1,468,750 )
ABVC common stock to be issued to BioLite as a result of the Merger     74,997,548  
ABVC common stock to be issued to BioKey as a result of the Merger     29,551,231  
Total common stock of the combined company outstanding following the Merger     313,519,004  

  

{e} Unless otherwise noted, adjustments to reflect the elimination of BioKey’s total equity, the estimated value of consideration to be paid in the Merger and to adjust, where required, the historical book values of BioKey’s assets and liabilities as of Sept 30, 2018 to the preliminary estimated fair value, in accordance with the acquisition method of accounting. The preliminary valuations were determined as of  and, where applicable, are based on the bid-and-ask share price of ABVC common stock on the final day of trading, July 6, 2018 The fair value of the consideration given and assets and liabilities acquired will be determined based on the underlying fair values as of the July 6, 2018.

  

Purchase consideration:      
Common stock (1)   $ 56,147,339  
Estimated Fair Value of Assets Acquired:        
Cash and cash equivalents   $ 733,843  
Accounts receivable     83,479  
Accounts receivable - related parties     142,225  
Property and equipment     64,375  
Security deposits     10,440  
Total assets acquired   $ 1,034,362  
Estimated Fair Value of Liabilities Assumed:        
Accrued expenses and other current liabilities   $ 84,980  
Tenant security deposit     2,880  
Total liabilities assumed   $ 87,860  
Total net assets acquired   $ 946,502  
Goodwill as a result of the Merger   $ 55,200,837  

 

(1) 29,551,231 shares of ABVC common stock to be issued to BioKey in connection with the Merger. Those shares were valued at $1.90 per share, the closing share price of ABVC on July 6, 2018.

 

{f} As of September 30, 2018, BioLite had $22,009 due from ABVC; and ABVC had $21,603 due to BioLite. The difference was mainly due to the translation adjustment, which would be reflected in accumulated other comprehensive income in equity section.

  

12

 

 

{g} Collaborative agreement with BioLite Inc., a related party

 

On December 29, 2015, American BriVision Corporation (“BriVision”) entered into a collaborative agreement (the “BioLite Collaborative Agreement”) with BioLite, a related party, pursuant to which BioLite granted BriVision sole licensing rights for drug and therapeutic use of five products, including BLI-1005 CNS-Major Depressive Disorder, BLI-1008 CNS-Attention Deficit Hyperactivity Disorder, BLI-1401-1 Anti-Tumor Combination Therapy-Solid Tumor with Anti-PD-1, BLI-1401-2 Anti-Tumor Combination Therapy-Triple Negative Breast Cancer, and BLI-1501 Hematology-Chronic Lymphocytic Leukemia, in the U.S.A and Canada. Under the BioLite Collaborative Agreement, BriVision should pay a total of $100,000,000 in cash or stock of BriVision with equivalent value, according to the following schedule:

 

  ●  upfront payment shall upon the signing of this BioLite Collaborative Agreement: 3.5% of total payment. After receiving upfront payment from BriVision, BioLite has to deliver all data to BriVision in one week.

 

  upon the first IND submission, BriVision shall pay, but no later than December 15, 2016: 6.5% of total payment. After receiving second payment from BriVision, BioLite has to deliver IND package to BriVision in one week.
     
  at the completion of first phase II clinical trial, BriVision shall pay, but no later than September 15, 2017: 15% of total payment. After receiving third payment from BriVision, BioLite has to deliver phase II clinical study report to BriVision in three months.
     
  upon the phase III IND submission, BriVision shall pay, but no later than December 15, 2018: 20% of total payment. After receiving forth payment from BriVision, BioLite has to deliver IND package to BriVision in one week.
     
  at the completion of phase III, BriVision shall pay, but no later than September 15, 2019:25% of total payment. After receiving fifth payment from BriVision, BioLite has to deliver phase III clinical study report to BriVision in three months.
     
  upon the NDA submission, BriVision shall pay, but no later than December 15, 2020, BriVision shall pay: 30% of total payment. After receiving sixth payment from BriVision, BioLite has to deliver NDA package to BriVision in one week. 

  

This BioLite Collaborative Agreement shall, once signed by both Parties, remain in effect for fifteen years as of the first commercial sales of the Product in the Territory and automatically renew for five more years unless either party gives the other party six month written notice of termination prior to the expiration date of the term.

 

Pursuant to the BioLite Collaborative Agreement, an upfront payment of $3,500,000 (the “Milestone Payment”), which is 3.5% of total payments due under the BioLite Collaborative Agreement, was to be paid by BriVision upon signing of that agreement. On May 6, 2016, BriVision and BioLite agreed to amend the BioLite Collaborative Agreement, through entry into the Milestone Payment Agreement, whereby BriVision agreed to pay the Milestone Payment to BioLite with $2,600,000 in cash and $900,000 in the form of newly issued shares of its common stock, at the price of $1.60 per share, for an aggregate number of 562,500 shares. The cash payment and shares issuance were completed in June 2016.

 

Pursuant to the BioLite Collaborative Agreement, the 6.5% of total payment, $6,500,000 shall be made upon the first IND submission which was submitted in March 2016. On February 2017, BriVision agreed to pay this amount to BioLite with $650,000 in cash and $5,850,000 in the form of newly issued shares of its common stock, at the price of $2.0 per share, for an aggregate number of 2,925,000 shares. The cash payment and shares issuance were completed in February 2017.

 

13

 

 

Pursuant to the BioLite Collaborative Agreement, the 15% of total payment, $15,000,000 shall be made at the completion of first phase II clinical trial. As of September 30, 2018 and December 31, 2017, the first phase II clinical trial research has not completed yet.

 

The aggregate common stock shares of American BriVision Corporation issued to BioLite pursuant to the BioLite Collaborative Agreement was 3,487,500 shares, the value of which was $6,750,000. The unaudited pro forma adjustments were made as if the Merger occurred on September 30, 2018. As such, these common stock shares of ABVC held by BioLite shall not be treated as outstanding shares, and shall be reflected as treasury shares. The corresponding long-term investment of BioLite has been written off in full amount, included in the accumulated deficit as of September 30, 2018. Such amount has been eliminated in the pro forma condensed balance sheet. Investment loss recognized as a result of the write-off amounted to $4,313,725 for the twelve months ended December 31, 2017. Such amount has been eliminated in the pro forma condensed statement of operations.

 

American BriVision Corporation determined to fully expense the entire amount of $10,000,000 according to ASC 730-10-25-1. The entire amount is fully expensed as research and development expense during the twelve months ended December 31, 2016, included in the accumulated deficit of ABVC as of September 30, 2018. The aggregate amount of $10,000,000 was recorded and remained as additional paid-in capital on BioLite as of September 30, 2018. Such amount has been eliminated in the pro forma condensed balance sheet. 

  

  {h} On August 26, 2016, ABVC issued 1,468,750 shares of common stock, par value $0.001 to BioLite pursuant to a certain Stock Purchase Agreement dated August 26, 2016. The purchase price per share of the Offering is $1.60. The net proceeds to the Company from the Offering are approximately $2,350,000.  The unaudited pro forma adjustments were made as if the Merger occurred on September 30, 2018. As such, these common stock shares of ABVC held by BioLite shall be treated be treated as outstanding shares, and shall be reflected as treasury shares. The corresponding long-term investment of BioLite has been written off in full amount, included in the accumulated deficit as of September 30, 2018. Such amount has been eliminated in the pro forma condensed balance sheet.

 

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