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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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¨
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Delaware
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71-0872999
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(State or other Jurisdiction of
Incorporation or Organization)
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(I.R.S. Employer
Identification No.)
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200 Penobscot Drive,
Redwood City, California
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94063
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(Address of Principal Executive Offices)
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(Zip Code)
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Title of Each Class:
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Name of Each Exchange on which Registered:
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Common Stock, par value $0.0001 per share
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The Nasdaq Global Select Market
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Large accelerated filer
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ý
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Accelerated filer
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¨
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Non-accelerated filer
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¨
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Smaller reporting company
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¨
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Emerging growth company
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¨
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PART I
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Item 1
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Item 1A
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Item 1B
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Item 2
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Item 3
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Item 4
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PART II
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Item 5
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Item 6
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Item 7
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Item 7A
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Item 8
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Item 9
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Item 9A
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Item 9B
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PART III
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Item 10
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Item 11
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Item 12
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Item 13
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Item 14
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PART IV
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Item 15
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•
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Licensing our CodeEvolver
®
protein engineering technology platform.
We intend to continue to pursue opportunities to license our CodeEvolver
®
protein engineering technology platform to third parties so they can create cost-saving protein catalyst solutions utilizing their own in-house protein engineering capability.
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Growing our pharmaceutical protein catalysts business.
We intend to continue to pursue opportunities in the pharmaceutical market to use our protein catalysis products and services to reduce the costs for manufacturing small
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Creating and advancing novel biotherapeutic drug candidates.
We intend to continue to pursue opportunities to apply our protein engineering capabilities to the creation and development of novel biotherapeutic drug candidates, both in partnership with customers and as proprietary Codexis drug candidates. We have also invested in research and development in an effort to generate additional early stage novel biotherapeutic candidates.
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•
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Growing our fine chemicals protein catalysts business.
We intend to continue to pursue opportunities in the fine chemicals market to use protein catalysis products and services to reduce the costs for manufacturing in adjacent markets like food and food ingredients. We intend to increase the number of fine chemical customers and processes who utilize and benefit from our novel, cost-saving protein catalyst solutions.
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•
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Developing high-performance enzymes for use in diagnostic applications
. We intend to offer high-performance enzymes to customers using NGS and PCR/qPCR for
in vitro
molecular diagnostic applications.
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completion of preclinical laboratory tests and animal studies performed in accordance with the FDA’s good laboratory practice (“GLP”) regulations;
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submission to the FDA of an IND, which must become effective before clinical trials in the United States may begin;
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performance of adequate and well-controlled human clinical trials to establish the safety and efficacy of the product candidate for each proposed indication, conducted in accordance with the FDA’s good clinical practice (“GCP”) regulations;
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submission to the FDA of a BLA;
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satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the product is produced to assess compliance with current good manufacturing (“cGMP”) regulations; and
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FDA review and approval of the BLA prior to any commercial marketing, sale or distribution of the product.
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Phase 1
-Phase 1 clinical trials involve initial introduction of the investigational product into healthy human subjects or patients with the target disease or condition. These studies are typically designed to test the safety,
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Phase 2
-Phase 2 clinical trials typically involve administration of the investigational product to a limited patient population with a specified disease or condition to evaluate the preliminary efficacy, optimal dosage and dosing schedule and to identify possible adverse side effects and safety risks.
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Phase 3
-Phase 3 clinical trials typically involve administration of the investigational product to an expanded patient population to further evaluate dosage, to provide statistically significant evidence of clinical efficacy and to further test for safety, generally at multiple geographically dispersed clinical trial sites. These clinical trials are intended to establish the overall risk/benefit ratio of the investigational product and to provide an adequate basis for product approval and physician labeling.
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restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the market or product recalls;
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fines, warning letters or holds on post-approval clinical trials;
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refusal of the FDA to approve applications or supplements to approved applications, or suspension or revocation of product approvals;
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product seizure or detention, or refusal to permit the import or export of products; or
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injunctions or the imposition of civil or criminal penalties.
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Percentage of Total Revenues
For The Years Ended December 31,
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2018
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2017
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2016
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Customers:
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Merck
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29
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%
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28
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%
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47
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%
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Nestlé Health Science
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22
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%
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15
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%
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*
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Tate & Lyle
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13
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%
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11
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%
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*
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Novartis
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*
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14
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%
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*
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GSK
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*
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*
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22
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%
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* Percentage was less than 10%
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•
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our ability to achieve or maintain profitability;
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our relationships with, and dependence on, collaborators in our principal markets;
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our dependence on a limited number of customers;
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our dependence on a limited number of products in our biocatalysis business;
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our reliance on a limited number of contract manufacturers for large scale production of substantially all of our enzyme products;
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our ability to develop and successfully commercialize new products for the biocatalysis market(s);
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our ability to obtain additional development partners for our biotherapeutic programs;
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potential of Nestlé Health Science terminating any development program under its license agreement with us;
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our ability to deploy our technology platform in the fine chemicals market;
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the success of our customers’ pharmaceutical products in the market and the ability of such customers to obtain regulatory approvals for products and processes;
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our or our customers’ ability to obtain regulatory approval for the sale and manufacturing of food products using our enzymes;
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our ability to deploy our technology platform in the
in vitro
molecular diagnostics market;
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our ability to successfully achieve domestic and foreign regulatory approval for product candidates;
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our ability to successfully design and execute clinical testing at a reasonable cost and on an acceptable time-frame;
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our dependence on product candidates which could unexpectedly fail at any stage of preclinical or clinical development;
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our dependence on product candidates which may lack the ability to work as intended or cause undesirable side effects;
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our dependency on third parties to conduct clinical trials, research, and preclinical studies;
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our ability to successfully prosecute and protect our intellectual property;
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our ability to compete if we do not adequately protect our proprietary technologies or if we lose some of our intellectual property rights;
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our ability to avoid infringing the intellectual property rights of third parties;
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our involvement in lawsuits to protect or enforce our patents or other intellectual property rights;
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our ability to enforce our intellectual property rights throughout the world;
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our dependence on, and the need to attract and retain, key management and other personnel;
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our ability to prevent the theft or misappropriation of our biocatalysts, the genes that code for our biocatalysts, know-how or technologies;
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our ability to protect our trade secrets and other proprietary information from disclosure by employees and others;
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our ability to obtain substantial additional capital that may be necessary to expand our business;
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our ability to comply with the terms of our credit facility;
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our ability to timely pay debt service obligations;
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our customers’ ability to pay amounts owed to us in a timely manner;
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our ability to avoid charges to earnings as a result of any impairment of goodwill, intangible assets or other long-lived assets;
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changes in financial accounting standards or practices may cause adverse, unexpected financial reporting fluctuations and affect our reported results of operations;
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our ability to maintain effective internal control over financial reporting;
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our dependency on information technology systems, infrastructure and data;
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our ability to control and to improve product gross margins;
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our ability to protect against risks associated with the international aspects of our business;
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the cost of compliance with European Union chemical regulations;
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potential advantages that our competitors and potential competitors may have in securing funding or developing products;
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our ability to accurately report our financial results in a timely manner;
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results of regulatory tax examinations;
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business interruptions, such as earthquakes and other natural disasters;
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public concerns about the ethical, legal and social ramifications of genetically engineered products and processes;
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our ability to integrate our current business with any businesses that we may acquire in the future;
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our ability to properly handle and dispose of hazardous materials in our business;
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potential product liability claims;
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uncertainties in the interpretation and application of the 2017 Tax Cuts and Jobs Act and related regulations could materially affect our tax obligations and effective tax rate; and
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our ability to use our net operating loss carryforwards to offset future taxable income.
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we do not achieve our research and development objectives under our collaboration agreements in a timely manner or at all;
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we develop products and processes or enter into additional collaborations that conflict with the business objectives of our other collaborators;
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we, our collaborators and/or our contract manufacturers do not receive the required regulatory and other approvals necessary for the commercialization of the applicable product;
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we disagree with our collaborators as to rights to intellectual property that are developed during the collaboration, or their research programs or commercialization activities;
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we are unable to manage multiple simultaneous collaborations;
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our collaborators or licensees are unable or unwilling to implement or use the technology or products that we provide or license to them;
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our collaborators become competitors of ours or enter into agreements with our competitors;
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our collaborators become unable or less willing to expend their resources on research and development or commercialization efforts due to general market conditions, their financial condition or other circumstances beyond our control; or
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our collaborators experience business difficulties, which could eliminate or impair their ability to effectively perform under our agreements.
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customers in these markets may be reluctant to adopt new manufacturing processes that use our enzymes;
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we may be unable to successfully develop the enzymes or manufacturing processes for our products in a timely and cost-effective manner, if at all;
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we may face difficulties in transferring the developed technologies to our customers and the contract manufacturers that we may use for commercial scale production of intermediates and enzymes in these markets;
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the contract manufacturers that we may use may be unable to scale their manufacturing operations to meet the demand for these products and we may be unable to secure additional manufacturing capacity;
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customers may not be willing to purchase these products for these markets from us on favorable terms, if at all;
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we may face product liability litigation, unexpected safety or efficacy concerns and product recalls or withdrawals;
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changes in laws or regulations relating to the pharmaceutical industry or the industries into which we sell our fine chemicals products, including the food industry, could cause us to incur increased costs of compliance or otherwise harm our business;
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our customers’ products may experience adverse events or face competition from new products, which would reduce demand for our products;
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we may face pressure from existing or new competitive products; and
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we may face pricing pressures from existing or new competitors, some of which may benefit from government subsidies or other incentives.
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completion of extensive preclinical laboratory tests and preclinical animal studies, all performed in accordance with GLP requirements;
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submission to the FDA of an IND, which must become effective before human clinical studies may begin in the United States;
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approval by an independent IRB representing each clinical site before the clinical study may be initiated at the site;
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performance of adequate and well-controlled human clinical studies (generally divided into three phases) in accordance with GCP requirements to establish the safety and efficacy of the product candidate for each proposed indication;
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preparation of and submission to the FDA of a BLA after completion of all clinical studies;
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potential review of the product candidate by an FDA advisory committee;
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satisfactory completion of an FDA pre-approval inspection of the manufacturing facilities where the product candidate is produced to assess compliance with cGMP requirements; and
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FDA review and approval of a BLA prior to any commercial marketing or sale of the product in the United States.
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The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming and the results are inherently unpredictable. If we are ultimately unable to obtain regulatory approval for biotherapeutic product candidates, our business will be harmed. To obtain regulatory approval to market any product candidate, preclinical studies and costly and lengthy clinical trials are required, and the results of the studies and trials are highly uncertain. A failure of one or more pre-clinical or clinical trials can occur at any stage, and many companies that have believed their drug candidates performed satisfactorily in pre-clinical and clinical testing have nonetheless failed to obtain marketing approval of their product candidates.
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We may find it difficult to enroll patients in our clinical trials for product candidates. Any enrollment difficulties could delay clinical trials and any potential product approval.
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We may experience difficulty or delay in obtaining the FDA’s acceptance of an IND for product candidates we may seek to enter into clinical development, which would delay initiation of Phase 1 clinical testing. Delays in the
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We have limited experience in drug development or regulatory matters related to drug development. As a result, we rely or will rely on third parties to conduct our pre-clinical and clinical studies, assist us with drug manufacturing and formulation and perform other tasks for us. If these third parties do not successfully carry out their responsibilities or comply with regulatory requirements, we may receive lower quality products or services, suffer reputational harm and not be able to obtain regulatory approval for product candidates.
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Our efforts to use CodeEvolver
®
protein engineering technology platform to generate new lead biotherapeutic candidates, whether under our collaboration with Nestlé Health Science or otherwise, may not be successful in creating candidates of value.
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We will be exposed to potential product liability risks through the testing of experimental therapeutics in humans, which may expose us to substantial uninsured liabilities.
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Third parties may develop intellectual property that could limit our ability to develop, market and commercialize product candidates.
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Changes in methods of treatment of disease, such as gene therapy, could cause us to stop development of our product candidate or reduce or eliminate potential demand for CDX-6114, if approved, or any other product candidates that we may develop in the future.
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the development of our product candidates subject to the agreement may be terminated or significantly delayed;
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our cash expenditures could increase significantly if it is necessary for us to hire additional employees and allocate scarce resources to the development and commercialization of product candidates;
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we would bear all of the risks and costs related to the further development and commercialization of product candidates that were previously the subject of the Nestlé Agreement, including the reimbursement of third parties; and
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in order to fund further development and commercialization of new product candidates or programs, we may need to seek out and establish alternative collaboration arrangements with third-party partners; this may not be possible, or we may not be able to do so on terms which are acceptable to us, in which case it may be necessary for us to limit the size or scope of one or more of our programs or increase our expenditures and seek additional funding by other means.
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the FDA or comparable foreign regulatory authorities may disagree with the design or implementation of our or our collaborators’ clinical trials;
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we or our collaborators may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that a product candidate is safe and effective for its proposed indication;
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the results of clinical trials may not meet the level of statistical significance required by the FDA or comparable foreign regulatory authorities for approval;
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we or our collaborators may be unable to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks;
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the FDA or comparable foreign regulatory authorities may disagree with our or our collaborators’ interpretation of data from preclinical studies or clinical trials;
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the data collected from clinical trials of product candidates may not be sufficient to support the submission of a BLA to obtain regulatory approval in the United States or elsewhere;
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the FDA or comparable foreign regulatory authorities may fail to approve the manufacturing processes or facilities of third-party manufacturers with which we or our collaborators contract for clinical and commercial supplies;
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the FDA or comparable foreign regulatory authorities may fail to approve the companion diagnostics we contemplate developing with collaborators; and
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the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our or our collaborators’ clinical data insufficient for approval.
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the inability to generate sufficient preclinical, toxicology or other
in vivo
or
in vitro
data to support the initiation of clinical trials;
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applicable regulatory authorities disagreeing as to the design or implementation of the clinical trials;
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obtaining regulatory authorization to commence a trial;
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reaching an agreement on acceptable terms with prospective contract research organizations, or CROs, and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;
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obtaining IRB approval at each site;
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developing and validating the companion diagnostic to be used in a clinical trial, if applicable;
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insufficient or inadequate supply or quality of product candidates or other materials necessary for use in clinical trials, or delays in sufficiently developing, characterizing or controlling a manufacturing process suitable for clinical trials;
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recruiting and retaining enough suitable patients to participate in a trial;
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having enough patients complete a trial or return for post-treatment follow-up;
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adding a sufficient number of clinical trial sites;
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inspections of clinical trial sites or operations by applicable regulatory authorities, or the imposition of a clinical hold;
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clinical sites deviating from trial protocol or dropping out of a trial;
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the inability to demonstrate the efficacy and benefits of a product candidate;
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discovering that product candidates have unforeseen safety issues, undesirable side effects or other unexpected characteristics;
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addressing patient safety concerns that arise during the course of a trial; receiving untimely or unfavorable feedback from applicable regulatory authorities regarding the trial or requests from regulatory authorities to modify the design of a trial;
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non-compliance with applicable regulatory requirements by us or third parties or changes in such regulations or administrative actions;
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suspensions or terminations by IRBs of the institutions at which such trials are being conducted, by the Data Safety Monitoring Board, or DSMB, for such trial or by the FDA or other regulatory authorities due to a number of factors, including those described above;
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third parties being unable or unwilling to satisfy their contractual obligations to us; or
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changes in our financial priorities, greater than anticipated costs of completing a trial or our inability to continue funding the trial.
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incur unplanned costs;
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be delayed in obtaining or fail to obtain marketing approval for product candidates;
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obtain marketing approval in some countries and not in others;
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obtain marketing approval for indications or patient populations that are not as broad as intended or desired;
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obtain marketing approval with labeling that includes significant use or distribution restrictions or safety warnings, including boxed warnings;
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be subject to additional post-marketing testing requirements;
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be subject to changes in the way the product is administered;
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have regulatory authorities withdraw or suspend their approval of the product or impose restrictions on its distribution;
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be sued; or
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experience damage to our reputation.
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severity and difficulty of diagnosing of the disease under investigation;
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size of the patient population and process for identifying subjects;
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eligibility and exclusion criteria for the trial in question;
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our or our collaborators’ ability to recruit clinical trial investigators with the appropriate competencies and experience;
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design of the trial protocol;
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availability and efficacy of approved medications or therapies, or other clinical trials, for the disease or condition under investigation;
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perceived risks and benefits of the product candidate under trial or testing, or of the application of genome editing to human indications;
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efforts to facilitate timely enrollment in clinical trials;
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patient referral practices of physicians;
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ability to obtain and maintain subject consent;
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risk that enrolled subjects will drop out before completion of the trial;
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ability to monitor patients adequately during and after treatment; and
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proximity and availability of clinical trial sites for prospective patients.
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regulatory authorities may suspend, withdraw or limit approvals of such product, or seek an injunction against its manufacture or distribution;
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regulatory authorities may require additional warnings on the label, including “boxed” warnings, or issue safety alerts, Dear Healthcare Provider letters, press releases or other communications containing warnings or other safety information about the product;
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we may be required to create a Medication Guide outlining the risks of such side effects for distribution to patients;
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we may be required to change the way a product is administered or conduct additional trials;
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the product may become less competitive;
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we or our collaborators may decide to remove the product from the marketplace;
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we may be subject to fines, injunctions or the imposition of civil or criminal penalties;
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we could be sued and be held liable for harm caused to patients; and
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our reputation may suffer.
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issue an untitled enforcement letter or a warning letter asserting a violation of the law;
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seek an injunction, impose civil and criminal penalties, and impose monetary fines, restitution or disgorgement of profits or revenues;
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suspend or withdraw regulatory approval;
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suspend or terminate any ongoing clinical trials or implement requirements to conduct post-marketing studies or clinical trials;
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refuse to approve a pending BLA or comparable foreign marketing application (or any supplements thereto) submitted by us or our collaborators;
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restrict the labeling, marketing, distribution, use or manufacturing of products;
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seize or detain products or otherwise require the withdrawal or recall of products from the market;
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refuse to approve pending applications or supplements to approved applications that we or our collaborators submit;
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refuse to permit the import or export of products; or
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refuse to allow us or our collaborators to enter into government contracts.
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an inability to initiate or continue clinical trials of our product candidates under development;
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delay in submitting regulatory applications, or receiving marketing approvals, for our product candidates;
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loss of the cooperation of future collaborators;
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subjecting third-party manufacturing facilities or our manufacturing facilities to additional inspections by regulatory authorities;
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requirements to cease development or to recall batches of our product candidates; and
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in the event of approval to market and commercialize our product candidates, an inability to meet commercial demands for our product or any other future product candidates.
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stop selling or using our products or technologies that use the subject intellectual property;
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pay monetary damages or substantial royalties;
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grant cross-licenses to third parties relating to our patents or proprietary rights;
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obtain from the third party asserting its intellectual property rights a license to sell or use the relevant technology, which license may not be available on reasonable terms, or at all; or
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redesign those products or processes that use any allegedly infringing technology, or relocate the operations relating to the allegedly infringing technology to another jurisdiction, which may result in significant cost or delay to us, could be technically infeasible or could prevent us from selling some of our products in the United States or other jurisdictions.
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we may be required to use a portion of our cash flow from operations to make debt service payments, thereby reducing the availability of our cash flow to fund working capital, capital expenditures, product development efforts, research and development, and other general corporate requirements;
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our interest expense could increase if prevailing interest rates increase, because a portion of draws which could be made under the Credit Facility bear interest at floating rates;
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the Credit Facility could reduce our flexibility to adjust to changing business conditions or obtain additional financing to fund working capital, capital expenditures, product development efforts, research and development, and other general corporate requirements; and
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restrictive covenants in our Credit Facility, which apply regardless of whether we draw down under the facility, limit our ability to, among other things, transfer collateral, incur additional indebtedness, engage in mergers or acquisitions, pay dividends or make other distributions, make investments, create liens and sell assets.
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changes in or interpretations of foreign regulations that may adversely affect our ability to sell our products, repatriate profits to the United States or operate our foreign-located facilities;
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the imposition of tariffs;
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the imposition of limitations on, or increase of, withholding and other taxes on remittances and other payments by foreign subsidiaries or joint ventures;
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the imposition of limitations on genetically-engineered products or processes and the production or sale of those products or processes in foreign countries;
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currency exchange rate fluctuations;
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uncertainties relating to foreign laws, regulations and legal proceedings including tax, import/export, anti-corruption and exchange control laws;
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the availability of government subsidies or other incentives that benefit competitors in their local markets that are not available to us;
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increased demands on our limited resources created by our operations may constrain the capabilities of our administrative and operational resources and restrict our ability to attract, train, manage and retain qualified management, technicians, scientists and other personnel;
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economic or political instability in foreign countries;
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difficulties associated with staffing and managing foreign operations; and
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•
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the need to comply with a variety of United States and foreign laws applicable to the conduct of international business, including import and export control laws and anti-corruption laws.
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•
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public attitudes about the safety and environmental hazards of, and ethical concerns over, genetic research and genetically engineered products and processes, which could influence public acceptance of our technologies, products and processes;
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public attitudes regarding, and potential changes to laws governing ownership of genetic material, which could harm our intellectual property rights with respect to our genetic material and discourage collaborators from supporting, developing, or commercializing our products, processes and technologies; and
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governmental reaction to negative publicity concerning genetically modified organisms, which could result in greater government regulation of genetic research and derivative products. The subject of genetically modified organisms has received negative publicity, which has aroused public debate. This adverse publicity could lead to greater regulation and trade restrictions on imports of genetically altered products. The protein catalysts that we develop have significantly enhanced characteristics compared to those found in naturally occurring enzymes or microbes. While we produce our biocatalysts only for use in a controlled industrial environment, the release of such biocatalysts into uncontrolled environments could have unintended consequences. Any adverse effect resulting from such a release could have a material adverse effect on our business and financial condition, and we may have exposure to liability for any resulting harm.
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•
|
issue additional equity securities, which would dilute our current stockholders;
|
•
|
incur substantial debt to fund the acquisitions;
|
•
|
use our cash to fund the acquisitions; or
|
•
|
assume significant liabilities including litigation risk.
|
•
|
actual or anticipated fluctuations in our financial condition and operating results;
|
•
|
the position of our cash, cash equivalents and equity securities;
|
•
|
actual or anticipated changes in our growth rate relative to our competitors;
|
•
|
actual or anticipated fluctuations in our competitors’ operating results or changes in their growth rate;
|
•
|
announcements of technological innovations by us, our collaborators or our competitors;
|
•
|
announcements by us, our collaborators or our competitors of significant acquisitions or dispositions, strategic partnerships, joint ventures or capital commitments;
|
•
|
additions or losses of one or more significant pharmaceutical products;
|
•
|
announcements or developments regarding pharmaceutical products manufactured using our protein catalysts and intermediates;
|
•
|
the entry into, modification or termination of collaborative arrangements;
|
•
|
additions or losses of customers;
|
•
|
additions or departures of key management or scientific personnel;
|
•
|
competition from existing products or new products that may emerge;
|
•
|
issuance of new or updated research reports by securities or industry analysts;
|
•
|
fluctuations in the valuation of companies perceived by investors to be comparable to us;
|
•
|
disputes or other developments related to proprietary rights, including patent litigation and our ability to obtain patent protection for our technologies;
|
•
|
contractual disputes or litigation with our partners, customers or suppliers;
|
•
|
announcement or expectation of additional financing efforts;
|
•
|
sales of our common stock by us, our insiders or our other stockholders;
|
•
|
share price and volume fluctuations attributable to inconsistent trading volume levels of our shares;
|
•
|
general market conditions in our industry; and
|
•
|
general economic and market conditions, including the recent financial crisis.
|
Fiscal 2018
|
High
|
|
Low
|
||||
First Quarter
|
$
|
13.60
|
|
|
$
|
7.95
|
|
Second Quarter
|
16.80
|
|
|
9.30
|
|
||
Third Quarter
|
19.60
|
|
|
12.85
|
|
||
Fourth Quarter
|
23.05
|
|
|
14.05
|
|
Fiscal 2017
|
High
|
|
Low
|
||||
First Quarter
|
$
|
5.29
|
|
|
$
|
3.60
|
|
Second Quarter
|
5.45
|
|
|
3.95
|
|
||
Third Quarter
|
6.70
|
|
|
4.80
|
|
||
Fourth Quarter
|
8.55
|
|
|
5.70
|
|
|
|
|
|
December 31,
|
||||||||||||||||||||||
$100 investment in stock or index
|
|
Ticker
|
|
2013
|
|
2014
|
|
2015
|
|
2016
|
|
2017
|
|
2018
|
||||||||||||
Codexis, Inc.
|
|
CDXS
|
|
$
|
100.00
|
|
|
$
|
180.00
|
|
|
$
|
302.14
|
|
|
$
|
328.57
|
|
|
$
|
596.43
|
|
|
$
|
1,192.86
|
|
Nasdaq Composite Total Return
|
|
XCMP
|
|
$
|
100.00
|
|
|
$
|
114.75
|
|
|
$
|
122.74
|
|
|
$
|
133.62
|
|
|
$
|
173.22
|
|
|
$
|
168.30
|
|
Nasdaq Biotechnology (Total Return) Index
|
|
XNBI
|
|
$
|
100.00
|
|
|
$
|
136.28
|
|
|
$
|
152.32
|
|
|
$
|
119.80
|
|
|
$
|
145.71
|
|
|
$
|
132.80
|
|
|
Year Ended December 31,
|
||||||||||||||||||
|
2018
|
|
2017
|
|
2016
|
|
2015
|
|
2014
|
||||||||||
|
(1)
|
|
|
|
|
|
|
|
|
||||||||||
|
(In Thousands, Except Per Share Amounts)
|
||||||||||||||||||
Consolidated Statements of Operations Data:
|
|
|
|
|
|
|
|
|
|
||||||||||
Revenues:
|
|
|
|
|
|
|
|
|
|
||||||||||
Product revenue
|
$
|
25,590
|
|
|
$
|
26,685
|
|
|
$
|
15,321
|
|
|
$
|
11,376
|
|
|
$
|
13,064
|
|
Research and development revenue
|
35,004
|
|
|
23,339
|
|
|
33,516
|
|
|
30,428
|
|
|
22,243
|
|
|||||
Total revenues
|
60,594
|
|
|
50,024
|
|
|
48,837
|
|
|
41,804
|
|
|
35,307
|
|
|||||
Costs and operating expenses:
|
|
|
|
|
|
|
|
|
|
||||||||||
Cost of product revenue
|
12,620
|
|
|
14,327
|
|
|
9,753
|
|
|
6,586
|
|
|
9,726
|
|
|||||
Research and development
|
29,978
|
|
|
29,659
|
|
|
22,229
|
|
|
20,673
|
|
|
22,755
|
|
|||||
Selling, general and administrative
|
29,291
|
|
|
29,008
|
|
|
25,419
|
|
|
22,315
|
|
|
21,937
|
|
|||||
Total costs and operating expenses
|
71,889
|
|
|
72,994
|
|
|
57,401
|
|
|
49,574
|
|
|
54,418
|
|
|||||
Loss from operations
|
(11,295
|
)
|
|
(22,970
|
)
|
|
(8,564
|
)
|
|
(7,770
|
)
|
|
(19,111
|
)
|
|||||
Interest income
|
671
|
|
|
147
|
|
|
60
|
|
|
19
|
|
|
18
|
|
|||||
Other expenses, net
|
(291
|
)
|
|
(92
|
)
|
|
(94
|
)
|
|
(168
|
)
|
|
(234
|
)
|
|||||
Loss before income taxes
|
(10,915
|
)
|
|
(22,915
|
)
|
|
(8,598
|
)
|
|
(7,919
|
)
|
|
(19,327
|
)
|
|||||
Provision for (benefit from) income taxes
|
(37
|
)
|
|
81
|
|
|
(40
|
)
|
|
(338
|
)
|
|
(256
|
)
|
|||||
Net loss
|
$
|
(10,878
|
)
|
|
$
|
(22,996
|
)
|
|
$
|
(8,558
|
)
|
|
$
|
(7,581
|
)
|
|
$
|
(19,071
|
)
|
Net loss per share, basic and diluted
|
$
|
(0.21
|
)
|
|
$
|
(0.50
|
)
|
|
$
|
(0.21
|
)
|
|
$
|
(0.19
|
)
|
|
$
|
(0.50
|
)
|
Weighted average common shares used in computing net loss per share, basic and diluted
|
52,205
|
|
|
46,228
|
|
|
40,629
|
|
|
39,438
|
|
|
38,209
|
|
|||||
|
|
|
|
|
|
|
|
|
|
||||||||||
(1)
Financial results for year ended December 31, 2018, as compared to the years ended December 31, 2017, 2016, 2015, and 2014 reflect the effects of adopting ASU 2014-09, “Revenue from Contracts with Customers (Topic 606)” and the related amendments (ASC 606), which provided a new basis of accounting for our revenue arrangements during fiscal year 2018. The adoption of ASC 606 limits the comparability of revenue and certain expenses, including revenues and costs and operating expenses, presented in the results of operations for the year ended December 31, 2018 when compared to the years ended December 31, 2017, 2016, 2015, and 2014. For additional information regarding the impact from adoption of this accounting standard, see Note 3, “Revenue Recognition” to the Consolidated Financial Statements set forth in Item 8 of this Annual Report on Form 10-K.
|
|
December 31,
|
||||||||||||||||||
|
2018
|
|
2017
|
|
2016
|
|
2015
|
|
2014
|
||||||||||
Consolidated Balance Sheets Data:
|
(In Thousands)
|
||||||||||||||||||
Cash, cash equivalents and restricted cash
|
$
|
54,485
|
|
|
$
|
32,776
|
|
|
$
|
20,864
|
|
|
$
|
24,060
|
|
|
$
|
27,198
|
|
Working capital
|
50,085
|
|
|
20,087
|
|
|
14,860
|
|
|
17,998
|
|
|
19,272
|
|
|||||
Total assets
|
79,283
|
|
|
53,625
|
|
|
35,648
|
|
|
44,647
|
|
|
48,122
|
|
|||||
Total liabilities
|
22,977
|
|
|
29,078
|
|
|
16,549
|
|
|
21,768
|
|
|
21,811
|
|
|||||
Total stockholders’ equity
|
56,306
|
|
|
24,547
|
|
|
19,099
|
|
|
22,879
|
|
|
26,311
|
|
|
Year Ended December 31,
|
|
% of Total Revenues
|
|||||||||||||||||
|
2018
|
|
2017
|
|
2016
|
|
2018
|
|
2017
|
|
2016
|
|||||||||
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||
Product revenue
|
$
|
25,590
|
|
|
$
|
26,685
|
|
|
$
|
15,321
|
|
|
42
|
%
|
|
53
|
%
|
|
31
|
%
|
Research and development revenue
|
35,004
|
|
|
23,339
|
|
|
33,516
|
|
|
58
|
%
|
|
47
|
%
|
|
69
|
%
|
|||
Total revenues
|
60,594
|
|
|
50,024
|
|
|
48,837
|
|
|
100
|
%
|
|
100
|
%
|
|
100
|
%
|
|||
Costs and operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||
Cost of product revenue
|
12,620
|
|
|
14,327
|
|
|
9,753
|
|
|
21
|
%
|
|
29
|
%
|
|
20
|
%
|
|||
Research and development
|
29,978
|
|
|
29,659
|
|
|
22,229
|
|
|
50
|
%
|
|
59
|
%
|
|
46
|
%
|
|||
Selling, general and administrative
|
29,291
|
|
|
29,008
|
|
|
25,419
|
|
|
48
|
%
|
|
58
|
%
|
|
52
|
%
|
|||
Total costs and operating expenses
|
71,889
|
|
|
72,994
|
|
|
57,401
|
|
|
119
|
%
|
|
146
|
%
|
|
118
|
%
|
|||
Loss from operations
|
(11,295
|
)
|
|
(22,970
|
)
|
|
(8,564
|
)
|
|
(19
|
)%
|
|
(46
|
)%
|
|
(18
|
)%
|
|||
Interest income
|
671
|
|
|
147
|
|
|
60
|
|
|
1
|
%
|
|
—
|
%
|
|
—
|
%
|
|||
Other expense, net
|
(291
|
)
|
|
(92
|
)
|
|
(94
|
)
|
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|||
Loss before income taxes
|
(10,915
|
)
|
|
(22,915
|
)
|
|
(8,598
|
)
|
|
(18
|
)%
|
|
(46
|
)%
|
|
(18
|
)%
|
|||
Provision for (benefit from) income taxes
|
(37
|
)
|
|
81
|
|
|
(40
|
)
|
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|||
Net loss
|
$
|
(10,878
|
)
|
|
$
|
(22,996
|
)
|
|
$
|
(8,558
|
)
|
|
(18
|
)%
|
|
(46
|
)%
|
|
(18
|
)%
|
•
|
Product revenue consist of sales of protein catalysts, pharmaceutical intermediates, and Codex
®
Biocatalyst Panels and Kits.
|
•
|
Research and development revenue include license, technology access and exclusivity fees, research services fees, milestone payments, royalties, optimization and screening fees, and revenue sharing arrangement based upon sales of licensed products by our former revenue sharing partner, Exela PharmSci, Inc. (“Exela”) in 2017 and 2016.
|
|
|
|
|
|
|
|
Change
|
||||||||||||||||
|
Year Ended December 31,
|
|
2018
|
|
2017
|
||||||||||||||||||
|
2018
|
|
2017
|
|
2016
|
|
$
|
|
%
|
|
$
|
|
%
|
||||||||||
Product revenue
|
$
|
25,590
|
|
|
$
|
26,685
|
|
|
$
|
15,321
|
|
|
$
|
(1,095
|
)
|
|
(4)%
|
|
$
|
11,364
|
|
|
74%
|
Research and development revenue
|
35,004
|
|
|
23,339
|
|
|
33,516
|
|
|
11,665
|
|
|
50%
|
|
(10,177
|
)
|
|
(30)%
|
|||||
Total revenues
|
$
|
60,594
|
|
|
$
|
50,024
|
|
|
$
|
48,837
|
|
|
$
|
10,570
|
|
|
21%
|
|
$
|
1,187
|
|
|
2%
|
|
|
|
|
|
|
|
Change
|
||||||||||||||||
|
Year Ended December 31,
|
|
2018
|
|
2017
|
||||||||||||||||||
|
2018
|
|
2017
|
|
2016
|
|
$
|
|
%
|
|
$
|
|
%
|
||||||||||
Cost of product revenue
|
$
|
12,620
|
|
|
$
|
14,327
|
|
|
$
|
9,753
|
|
|
$
|
(1,707
|
)
|
|
(12)%
|
|
$
|
4,574
|
|
|
47%
|
Research and development
|
29,978
|
|
|
29,659
|
|
|
22,229
|
|
|
319
|
|
|
1%
|
|
7,430
|
|
|
33%
|
|||||
Selling, general and administrative
|
29,291
|
|
|
29,008
|
|
|
25,419
|
|
|
283
|
|
|
1%
|
|
3,589
|
|
|
14%
|
|||||
Total costs and operating expenses
|
$
|
71,889
|
|
|
$
|
72,994
|
|
|
$
|
57,401
|
|
|
$
|
(1,105
|
)
|
|
(2)%
|
|
$
|
15,593
|
|
|
27%
|
|
Year Ended December 31,
|
|
Change
|
|
Year Ended December 31,
|
|
Change
|
||||||||||||||||||||
|
2018
|
|
2017
|
|
$
|
|
%
|
|
2017
|
|
2016
|
|
$
|
|
%
|
||||||||||||
Product revenue
|
$
|
25,590
|
|
|
$
|
26,685
|
|
|
$
|
(1,095
|
)
|
|
(4)%
|
|
$
|
26,685
|
|
|
$
|
15,321
|
|
|
$
|
11,364
|
|
|
74%
|
Cost of product revenue
(1)
|
12,620
|
|
|
14,327
|
|
|
(1,707
|
)
|
|
(12)%
|
|
14,327
|
|
|
9,753
|
|
|
4,574
|
|
|
47%
|
||||||
Product gross profit
|
$
|
12,970
|
|
|
$
|
12,358
|
|
|
$
|
612
|
|
|
5%
|
|
$
|
12,358
|
|
|
$
|
5,568
|
|
|
$
|
6,790
|
|
|
122%
|
Product gross margin (%)
(2)
|
51
|
%
|
|
46
|
%
|
|
|
|
|
|
46
|
%
|
|
36
|
%
|
|
|
|
|
|
|
|
|
|
|
|
Change
|
||||||||||||||||
|
Year Ended December 31,
|
|
2018
|
|
2017
|
||||||||||||||||||
|
2018
|
|
2017
|
|
2016
|
|
$
|
|
%
|
|
$
|
|
%
|
||||||||||
Interest income
|
$
|
671
|
|
|
$
|
147
|
|
|
$
|
60
|
|
|
$
|
524
|
|
|
356%
|
|
$
|
87
|
|
|
145%
|
Other expense, net
|
(291
|
)
|
|
(92
|
)
|
|
(94
|
)
|
|
199
|
|
|
216%
|
|
(2
|
)
|
|
(2)%
|
|||||
Total other income (expense), net
|
$
|
380
|
|
|
$
|
55
|
|
|
$
|
(34
|
)
|
|
$
|
325
|
|
|
591%
|
|
$
|
89
|
|
|
262%
|
|
|
|
|
|
|
|
Change
|
||||||||||||||||
|
Year Ended December 31,
|
|
2018
|
|
2017
|
||||||||||||||||||
|
2018
|
|
2017
|
|
2016
|
|
$
|
|
%
|
|
$
|
|
%
|
||||||||||
Provision for (benefit from) income taxes
|
$
|
(37
|
)
|
|
$
|
81
|
|
|
$
|
(40
|
)
|
|
$
|
118
|
|
|
146%
|
|
$
|
(121
|
)
|
|
(303)%
|
|
Year Ended December 31, 2018
|
|
Year Ended December 31, 2017
|
|
Change
|
||||||||||||||||||||||||||||||
|
Performance Enzymes
|
|
Novel Biotherapeutics
|
|
Total
|
|
Performance Enzymes
|
|
Novel Biotherapeutics
|
|
Total
|
|
Performance Enzymes
|
|
Novel Biotherapeutics
|
||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
|
%
|
|
$
|
|
%
|
||||||||||||||||
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
Product revenue
|
$
|
25,590
|
|
|
$
|
—
|
|
|
$
|
25,590
|
|
|
$
|
26,685
|
|
|
$
|
—
|
|
|
$
|
26,685
|
|
|
$
|
(1,095
|
)
|
|
(4)%
|
|
$
|
—
|
|
|
—%
|
Research and development revenue
|
21,483
|
|
|
13,521
|
|
|
35,004
|
|
|
15,648
|
|
|
7,691
|
|
|
23,339
|
|
|
5,835
|
|
|
37%
|
|
5,830
|
|
|
76%
|
||||||||
Total revenues
|
$
|
47,073
|
|
|
$
|
13,521
|
|
|
$
|
60,594
|
|
|
$
|
42,333
|
|
|
$
|
7,691
|
|
|
$
|
50,024
|
|
|
$
|
4,740
|
|
|
11%
|
|
$
|
5,830
|
|
|
76%
|
|
Year Ended December 31, 2018
|
|
Year Ended December 31, 2017
|
|
Change
|
||||||||||||||||||||||||||||||
|
Performance Enzymes
|
|
Novel Biotherapeutics
|
|
Total
|
|
Performance Enzymes
|
|
Novel Biotherapeutics
|
|
Total
|
|
Performance Enzymes
|
|
Novel Biotherapeutics
|
||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
|
%
|
|
$
|
|
%
|
||||||||||||||||
Cost of product revenue
|
$
|
12,620
|
|
|
$
|
—
|
|
|
$
|
12,620
|
|
|
$
|
14,327
|
|
|
$
|
—
|
|
|
$
|
14,327
|
|
|
$
|
(1,707
|
)
|
|
(12)%
|
|
$
|
—
|
|
|
—%
|
Research and development
(1)
|
18,924
|
|
|
10,185
|
|
|
29,109
|
|
|
16,847
|
|
|
12,107
|
|
|
28,954
|
|
|
2,077
|
|
|
12%
|
|
(1,922
|
)
|
|
(16)%
|
||||||||
Selling, general and administrative
(1)
|
7,538
|
|
|
771
|
|
|
8,309
|
|
|
7,371
|
|
|
—
|
|
|
7,371
|
|
|
167
|
|
|
2%
|
|
771
|
|
|
100%
|
||||||||
Total segment costs and operating expenses
|
$
|
39,082
|
|
|
$
|
10,956
|
|
|
50,038
|
|
|
$
|
38,545
|
|
|
$
|
12,107
|
|
|
50,652
|
|
|
$
|
537
|
|
|
1%
|
|
$
|
(1,151
|
)
|
|
(10)%
|
||
Corporate costs
|
|
|
|
|
20,704
|
|
|
|
|
|
|
21,300
|
|
|
|
|
|
|
|
|
|
||||||||||||||
Depreciation
|
|
|
|
|
1,147
|
|
|
|
|
|
|
1,042
|
|
|
|
|
|
|
|
|
|
||||||||||||||
Total costs and operating expenses
|
|
|
|
|
$
|
71,889
|
|
|
|
|
|
|
$
|
72,994
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, 2018
|
|
Year Ended December 31, 2017
|
|
Change
|
||||||||||||||||||||||||||||
|
Performance Enzymes
|
|
Novel Biotherapeutics
|
|
Total
|
|
Performance Enzymes
|
|
Novel Biotherapeutics
|
|
Total
|
|
Performance Enzymes
|
|
Novel Biotherapeutics
|
||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
|
%
|
|
$
|
|
%
|
||||||||||||||
Income (loss) from operations
|
$
|
7,991
|
|
|
$
|
2,565
|
|
|
10,556
|
|
|
$
|
3,788
|
|
|
$
|
(4,416
|
)
|
|
(628
|
)
|
|
$
|
4,203
|
|
|
111%
|
|
$
|
6,981
|
|
|
158%
|
|
December 31,
|
||||||||||
(In Thousands)
|
2018
|
|
2017
|
|
2016
|
||||||
Cash and cash equivalents
|
$
|
53,039
|
|
|
$
|
31,219
|
|
|
$
|
19,240
|
|
Working capital
|
50,085
|
|
|
20,087
|
|
|
14,860
|
|
|
Year Ended December 31,
|
||||||||||
(In Thousands)
|
2018
|
|
2017
|
|
2016
|
||||||
Net cash used in operating activities
|
$
|
(14,094
|
)
|
|
$
|
(8,755
|
)
|
|
$
|
(1,860
|
)
|
Net cash used in investing activities
|
(2,766
|
)
|
|
(983
|
)
|
|
(846
|
)
|
|||
Net cash provided by (used in) financing activities
|
38,569
|
|
|
21,650
|
|
|
(490
|
)
|
|||
Net increase (decrease) in cash, cash equivalents and restricted cash
|
$
|
21,709
|
|
|
$
|
11,912
|
|
|
$
|
(3,196
|
)
|
|
Payments due by period
|
||||||||||||||||||
|
Total
|
|
Less than 1 year
|
|
1 to 3 years
|
|
4 to 5 years
|
|
More than 5 years
|
||||||||||
Capital lease obligations
|
$
|
313
|
|
|
$
|
252
|
|
|
$
|
61
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Operating leases obligations
(1)
|
4,523
|
|
|
3,280
|
|
|
1,202
|
|
|
41
|
|
|
—
|
|
|||||
Total
(2)
|
$
|
4,836
|
|
|
$
|
3,532
|
|
|
$
|
1,263
|
|
|
$
|
41
|
|
|
$
|
—
|
|
(1)
|
Represents future minimum lease payments under non-cancellable operating leases in effect as of
December 31, 2018
for our facilities in Redwood City, California. The minimum lease payments above do not include common area maintenance charges or real estate taxes. Minimum payments have not been reduced by future minimum sublease rentals of
$0.9 million
to be received under non-cancellable subleases.
|
(2)
|
Excludes
$0.7 million
of uncertain tax liabilities for which we cannot make a reasonably reliable estimate of the period of cash settlement.
|
|
Payments due by period
|
||||||||||||||||||
|
Total
|
|
Less than 1 year
|
|
1 to 3 years
|
|
4 to 5 years
|
|
More than 5 years
|
||||||||||
Operating leases obligations
|
$
|
32,865
|
|
|
$
|
—
|
|
|
$
|
5,812
|
|
|
$
|
8,833
|
|
|
$
|
18,220
|
|
Other Commitment Agreement Type
|
|
Agreement Date
|
|
Future Minimum Payment
|
||
Manufacture and supply agreement with expected future payment date of December, 2022
|
|
April 2016
|
|
$
|
1,458
|
|
Service agreement for stability study
|
|
July 2017
|
|
331
|
|
|
Service agreement for clinical trial
|
|
December 2017
|
|
1,258
|
|
|
Total other commitments
|
|
|
|
$
|
3,047
|
|
|
December 31,
|
||||||
|
2018
|
|
2017
|
||||
Assets
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
53,039
|
|
|
$
|
31,219
|
|
Accounts receivable, net of allowances of $34 at December 31, 2018 and 2017
|
11,551
|
|
|
11,447
|
|
||
Unbilled receivables, current
|
1,916
|
|
|
353
|
|
||
Inventories
|
589
|
|
|
1,036
|
|
||
Prepaid expenses and other current assets
|
1,068
|
|
|
984
|
|
||
Contract assets
|
35
|
|
|
—
|
|
||
Total current assets
|
68,198
|
|
|
45,039
|
|
||
Restricted cash
|
1,446
|
|
|
1,557
|
|
||
Equity securities
|
588
|
|
|
671
|
|
||
Property and equipment, net
|
4,759
|
|
|
2,815
|
|
||
Goodwill
|
3,241
|
|
|
3,241
|
|
||
Other non-current assets
|
1,051
|
|
|
302
|
|
||
Total assets
|
$
|
79,283
|
|
|
$
|
53,625
|
|
Liabilities and Stockholders’ Equity
|
|
|
|
||||
Current liabilities:
|
|
|
|
||||
Accounts payable
|
$
|
3,050
|
|
|
$
|
3,545
|
|
Accrued compensation
|
5,272
|
|
|
4,753
|
|
||
Other accrued liabilities
|
4,855
|
|
|
4,362
|
|
||
Deferred revenue
|
4,936
|
|
|
12,292
|
|
||
Total current liabilities
|
18,113
|
|
|
24,952
|
|
||
Deferred revenue, net of current portion
|
3,352
|
|
|
1,501
|
|
||
Lease incentive obligation, net of current portion
|
35
|
|
|
460
|
|
||
Capital lease obligation, net of current portion
|
61
|
|
|
302
|
|
||
Other long-term liabilities
|
1,416
|
|
|
1,863
|
|
||
Total liabilities
|
22,977
|
|
|
29,078
|
|
||
|
|
|
|
||||
Commitments and contingencies (Note 13)
|
|
|
|
||||
Stockholders’ equity:
|
|
|
|
||||
Preferred stock, $0.0001 par value per share; 5,000 shares authorized, none issued and outstanding
|
—
|
|
|
—
|
|
||
Common stock, $0.0001 par value per share; 100,000 shares authorized; 54,065 and 48,365 shares issued and outstanding at December 31, 2018 and December 31, 2017, respectively
|
5
|
|
|
5
|
|
||
Additional paid-in capital
|
386,775
|
|
|
340,079
|
|
||
Accumulated other comprehensive loss
|
—
|
|
|
(472
|
)
|
||
Accumulated deficit
|
(330,474
|
)
|
|
(315,065
|
)
|
||
Total stockholders’ equity
|
56,306
|
|
|
24,547
|
|
||
Total liabilities and stockholders’ equity
|
$
|
79,283
|
|
|
$
|
53,625
|
|
|
Year Ended December 31,
|
||||||||||
|
2018
|
|
2017
|
|
2016
|
||||||
Revenues:
|
|
|
|
|
|
||||||
Product revenue
|
$
|
25,590
|
|
|
$
|
26,685
|
|
|
$
|
15,321
|
|
Research and development revenue
|
35,004
|
|
|
23,339
|
|
|
33,516
|
|
|||
Total revenues
|
60,594
|
|
|
50,024
|
|
|
48,837
|
|
|||
Costs and operating expenses:
|
|
|
|
|
|
||||||
Cost of product revenue
|
12,620
|
|
|
14,327
|
|
|
9,753
|
|
|||
Research and development
|
29,978
|
|
|
29,659
|
|
|
22,229
|
|
|||
Selling, general and administrative
|
29,291
|
|
|
29,008
|
|
|
25,419
|
|
|||
Total costs and operating expenses
|
71,889
|
|
|
72,994
|
|
|
57,401
|
|
|||
Loss from operations
|
(11,295
|
)
|
|
(22,970
|
)
|
|
(8,564
|
)
|
|||
Interest income
|
671
|
|
|
147
|
|
|
60
|
|
|||
Other expenses, net
|
(291
|
)
|
|
(92
|
)
|
|
(94
|
)
|
|||
Loss before income taxes
|
(10,915
|
)
|
|
(22,915
|
)
|
|
(8,598
|
)
|
|||
Provision for (benefit from) income taxes
|
(37
|
)
|
|
81
|
|
|
(40
|
)
|
|||
Net loss
|
$
|
(10,878
|
)
|
|
$
|
(22,996
|
)
|
|
$
|
(8,558
|
)
|
|
|
|
|
|
|
||||||
Net loss per share, basic and diluted
|
$
|
(0.21
|
)
|
|
$
|
(0.50
|
)
|
|
$
|
(0.21
|
)
|
Weighted average common stock shares used in computing net loss per share, basic and diluted
|
52,205
|
|
|
46,228
|
|
|
40,629
|
|
|
Year Ended December 31,
|
||||||||||
|
2018
|
|
2017
|
|
2016
|
||||||
Net loss
|
$
|
(10,878
|
)
|
|
$
|
(22,996
|
)
|
|
$
|
(8,558
|
)
|
Other comprehensive loss:
|
|
|
|
|
|
||||||
Unrealized loss on equity securities, net of tax
(1)
|
—
|
|
|
(472
|
)
|
|
(405
|
)
|
|||
Other comprehensive loss
|
—
|
|
|
(472
|
)
|
|
(405
|
)
|
|||
Total comprehensive loss
|
$
|
(10,878
|
)
|
|
$
|
(23,468
|
)
|
|
$
|
(8,963
|
)
|
|
|
Common Stock
|
|
Additional
Paid-in
Capital
|
|
Accumulated
Other
Comprehensive
Income (Loss)
|
|
Accumulated
Deficit
|
|
Total
Stockholders’ Equity |
|||||||||||||
|
|
Shares
|
|
Amount
|
|
||||||||||||||||||
December 31, 2015
|
|
40,343
|
|
|
$
|
4
|
|
|
$
|
305,981
|
|
|
$
|
405
|
|
|
$
|
(283,511
|
)
|
|
$
|
22,879
|
|
Exercise of stock options
|
|
398
|
|
|
—
|
|
|
1,034
|
|
|
—
|
|
|
—
|
|
|
1,034
|
|
|||||
Release of stock awards
|
|
911
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Employee stock-based compensation
|
|
—
|
|
|
—
|
|
|
5,673
|
|
|
—
|
|
|
—
|
|
|
5,673
|
|
|||||
Taxes paid related to net share settlement of equity awards
|
|
(397
|
)
|
|
—
|
|
|
(1,524
|
)
|
|
—
|
|
|
—
|
|
|
(1,524
|
)
|
|||||
Total comprehensive loss
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(405
|
)
|
|
(8,558
|
)
|
|
(8,963
|
)
|
|||||
December 31, 2016
|
|
41,255
|
|
|
4
|
|
|
311,164
|
|
|
—
|
|
|
(292,069
|
)
|
|
19,099
|
|
|||||
Exercise of stock options
|
|
86
|
|
|
—
|
|
|
266
|
|
|
—
|
|
|
—
|
|
|
266
|
|
|||||
Release of stock awards
|
|
1,096
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Employee stock-based compensation
|
|
—
|
|
|
—
|
|
|
7,048
|
|
|
—
|
|
|
—
|
|
|
7,048
|
|
|||||
Non-employee stock-based compensation
|
|
—
|
|
|
—
|
|
|
43
|
|
|
—
|
|
|
—
|
|
|
43
|
|
|||||
Taxes paid related to net share settlement of equity awards
|
|
(397
|
)
|
|
—
|
|
|
(1,670
|
)
|
|
—
|
|
|
—
|
|
|
(1,670
|
)
|
|||||
Issuance of common stock, net of issuance costs
|
|
6,325
|
|
|
1
|
|
|
23,228
|
|
|
—
|
|
|
—
|
|
|
23,229
|
|
|||||
Total comprehensive loss
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(472
|
)
|
|
(22,996
|
)
|
|
(23,468
|
)
|
|||||
December 31, 2017
|
|
48,365
|
|
|
5
|
|
|
340,079
|
|
|
(472
|
)
|
|
(315,065
|
)
|
|
24,547
|
|
|||||
Exercise of stock options
|
|
856
|
|
|
—
|
|
|
4,680
|
|
|
—
|
|
|
—
|
|
|
4,680
|
|
|||||
Release of stock awards
|
|
832
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Employee stock-based compensation
|
|
—
|
|
|
—
|
|
|
7,865
|
|
|
—
|
|
|
—
|
|
|
7,865
|
|
|||||
Non-employee stock-based compensation
|
|
—
|
|
|
—
|
|
|
24
|
|
|
—
|
|
|
—
|
|
|
24
|
|
|||||
Taxes paid related to net share settlement of equity awards
|
|
(301
|
)
|
|
—
|
|
|
(3,190
|
)
|
|
—
|
|
|
—
|
|
|
(3,190
|
)
|
|||||
Issuance of common stock, net of issuance costs
|
|
4,313
|
|
|
—
|
|
|
37,317
|
|
|
—
|
|
|
—
|
|
|
37,317
|
|
|||||
Cumulative effect of change in accounting principles
(1)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
472
|
|
|
(4,531
|
)
|
|
(4,059
|
)
|
|||||
Net Loss
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(10,878
|
)
|
|
$
|
(10,878
|
)
|
||||
December 31, 2018
|
|
54,065
|
|
|
$
|
5
|
|
|
$
|
386,775
|
|
|
$
|
—
|
|
|
$
|
(330,474
|
)
|
|
$
|
56,306
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
(1)
Cumulative effect of change in accounting principles includes: Accounting Standards Update 2014-9 (Topic 606), of $4.1 million and Accounting Standards Update 2016-01 (Subtopic 825-10), of $0.5 million. See Note 2 “Summary of Significant Accounting Policies” in the Accompanying Notes to the Consolidated Financial Statements for more information.
|
|
Year Ended December 31,
|
||||||||||
|
2018
|
|
2017
|
|
2016
|
||||||
Operating activities:
|
|
|
|
|
|
||||||
Net loss
|
$
|
(10,878
|
)
|
|
$
|
(22,996
|
)
|
|
$
|
(8,558
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
||||||
Amortization of intangible assets
|
—
|
|
|
—
|
|
|
2,812
|
|
|||
Depreciation
|
1,147
|
|
|
1,042
|
|
|
1,734
|
|
|||
Stock-based compensation
|
7,889
|
|
|
7,091
|
|
|
5,673
|
|
|||
Loss (gain) on disposal of property and equipment
|
8
|
|
|
9
|
|
|
(42
|
)
|
|||
Loss on investment securities
|
83
|
|
|
—
|
|
|
—
|
|
|||
Gain from extinguishment of asset retirement obligation
|
—
|
|
|
(207
|
)
|
|
—
|
|
|||
Changes in operating assets and liabilities:
|
|
|
|
|
|
||||||
Accounts receivable, net
|
960
|
|
|
(5,298
|
)
|
|
1,405
|
|
|||
Inventories
|
447
|
|
|
(210
|
)
|
|
167
|
|
|||
Prepaid expenses and other current assets
|
(37
|
)
|
|
157
|
|
|
7
|
|
|||
Contract assets
|
(35
|
)
|
|
—
|
|
|
—
|
|
|||
Unbilled receivables
|
(2,349
|
)
|
|
(353
|
)
|
|
—
|
|
|||
Other non-current assets
|
228
|
|
|
(44
|
)
|
|
52
|
|
|||
Accounts payable
|
(524
|
)
|
|
(801
|
)
|
|
942
|
|
|||
Accrued compensation
|
519
|
|
|
439
|
|
|
983
|
|
|||
Other accrued liabilities
|
(17
|
)
|
|
1,399
|
|
|
(593
|
)
|
|||
Other long-term liabilities
|
(904
|
)
|
|
—
|
|
|
—
|
|
|||
Deferred revenue
|
(10,631
|
)
|
|
11,017
|
|
|
(6,442
|
)
|
|||
Net cash used in operating activities
|
(14,094
|
)
|
|
(8,755
|
)
|
|
(1,860
|
)
|
|||
Investing activities:
|
|
|
|
|
|
||||||
Purchase of property and equipment
|
(2,768
|
)
|
|
(985
|
)
|
|
(888
|
)
|
|||
Proceeds from disposal of property and equipment
|
2
|
|
|
2
|
|
|
42
|
|
|||
Net cash used in investing activities
|
(2,766
|
)
|
|
(983
|
)
|
|
(846
|
)
|
|||
Financing activities:
|
|
|
|
|
|
||||||
Proceeds from exercises of stock options
|
4,680
|
|
|
266
|
|
|
1,034
|
|
|||
Proceeds from issuance of common stock in connection with public offering, net of underwriting discounts and commission
|
37,497
|
|
|
23,782
|
|
|
—
|
|
|||
Costs incurred in connection with public offering
|
(180
|
)
|
|
(553
|
)
|
|
—
|
|
|||
Principal payments on capital lease obligations
|
(238
|
)
|
|
(175
|
)
|
|
—
|
|
|||
Taxes paid related to net share settlement of equity awards
|
(3,190
|
)
|
|
(1,670
|
)
|
|
(1,524
|
)
|
|||
Net cash provided by (used in) financing activities
|
38,569
|
|
|
21,650
|
|
|
(490
|
)
|
|||
Net increase (decrease) in cash, cash equivalents and restricted cash
|
21,709
|
|
|
11,912
|
|
|
(3,196
|
)
|
|||
Cash, cash equivalents and restricted cash at the beginning of the year
|
32,776
|
|
|
20,864
|
|
|
24,060
|
|
|||
Cash, cash equivalents and restricted cash at the end of the year
|
$
|
54,485
|
|
|
$
|
32,776
|
|
|
$
|
20,864
|
|
|
|
|
|
|
|
||||||
Supplemental disclosure of cash flow information:
|
|
|
|
|
|
||||||
Interest paid
|
$
|
84
|
|
|
$
|
141
|
|
|
$
|
14
|
|
Income taxes
|
$
|
5
|
|
|
$
|
32
|
|
|
$
|
5
|
|
Supplemental non-cash financing activities:
|
|
|
|
|
|
|
|
|
|||
Equipment acquired under capital leases
|
$
|
—
|
|
|
$
|
862
|
|
|
$
|
—
|
|
Capital expenditures incurred but not yet paid
|
$
|
300
|
|
|
$
|
42
|
|
|
$
|
125
|
|
|
Year Ended December 31,
|
||||||||||
|
2018
|
|
2017
|
|
2016
|
||||||
Cash and cash equivalents
|
$
|
53,039
|
|
|
$
|
31,219
|
|
|
$
|
19,240
|
|
Restricted cash included in non-current assets
|
1,446
|
|
|
1,557
|
|
|
1,624
|
|
|||
Total cash, cash equivalents and restricted cash at the end of the period
|
$
|
54,485
|
|
|
$
|
32,776
|
|
|
$
|
20,864
|
|
•
|
Level 1: Inputs that are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date.
|
•
|
Level 2: Inputs that are either directly or indirectly observable for the asset or liability through correlation with market data at the measurement date and for the duration of the instrument’s anticipated life.
|
•
|
Level 3: Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities and which reflect management’s best estimate of what market participants would use in pricing the asset or liability at the measurement date.
|
|
Asset classification
|
Estimated useful life
|
|
Laboratory equipment
|
5 years
|
|
Computer equipment and software
|
3 to 5 years
|
|
Office equipment and furniture
|
5 years
|
|
Leasehold improvements
|
Lesser of useful life or lease term
|
|
Year Ended December 31, 2018
|
||||||||||
|
Performance Enzymes
|
|
Novel Biotherapeutics
|
|
Total
|
||||||
Major products and service:
|
|
|
|
|
|
||||||
Product Revenue
|
$
|
25,590
|
|
|
$
|
—
|
|
|
$
|
25,590
|
|
Research and development revenue
|
21,483
|
|
|
13,521
|
|
|
35,004
|
|
|||
Total revenues
|
$
|
47,073
|
|
|
$
|
13,521
|
|
|
$
|
60,594
|
|
|
|
|
|
|
|
||||||
Primary geographical markets:
|
|
|
|
|
|
||||||
Americas
|
$
|
15,332
|
|
|
$
|
38
|
|
|
$
|
15,370
|
|
EMEA
|
8,878
|
|
|
13,483
|
|
|
22,361
|
|
|||
APAC
|
22,863
|
|
|
—
|
|
|
22,863
|
|
|||
Total revenues
|
$
|
47,073
|
|
|
$
|
13,521
|
|
|
$
|
60,594
|
|
|
Year Ended December 31, 2017
|
||||||||||
|
Performance Enzymes
|
|
Novel Biotherapeutics
|
|
Total
|
||||||
Major products and service:
|
|
|
|
|
|
||||||
Product Revenue
|
$
|
26,685
|
|
|
$
|
—
|
|
|
$
|
26,685
|
|
Research and development revenue
|
15,648
|
|
|
7,691
|
|
|
23,339
|
|
|||
Total revenues
|
$
|
42,333
|
|
|
$
|
7,691
|
|
|
$
|
50,024
|
|
|
|
|
|
|
|
||||||
Primary geographical markets:
|
|
|
|
|
|
||||||
Americas
|
$
|
15,575
|
|
|
$
|
—
|
|
|
$
|
15,575
|
|
EMEA
|
11,919
|
|
|
7,691
|
|
|
19,610
|
|
|||
APAC
|
14,839
|
|
|
—
|
|
|
14,839
|
|
|||
Total revenues
|
$
|
42,333
|
|
|
$
|
7,691
|
|
|
$
|
50,024
|
|
|
Balance
|
||
Deferred Revenue, balance at December 31, 2017
|
$
|
13,793
|
|
Changes in estimated consideration
|
—
|
|
|
Unsatisfied performance obligations
|
$
|
5,173
|
|
Deferred Revenue, balance at January 1, 2018
|
$
|
18,966
|
|
|
January 1, 2018 balance
|
|
Additions
|
|
Deductions
(1)
|
|
December 31, 2018
|
||||||
Contract Assets
|
$
|
—
|
|
|
8,934
|
|
|
(8,899
|
)
|
|
$
|
35
|
|
Unbilled receivables, current
|
$
|
—
|
|
|
2,908
|
|
|
(992
|
)
|
|
$
|
1,916
|
|
Unbilled receivables, non-current
|
$
|
—
|
|
|
786
|
|
|
—
|
|
|
$
|
786
|
|
Contract Costs
|
$
|
239
|
|
|
—
|
|
|
(197
|
)
|
|
$
|
42
|
|
Contract Liabilities: Deferred Revenue
|
$
|
18,966
|
|
|
6,446
|
|
|
(17,124
|
)
|
|
$
|
8,288
|
|
Revenue recognized in the period for:
|
Year Ended December 31, 2018
|
||
Amounts included in contract liabilities at the beginning of the period:
|
|
||
Performance obligations satisfied
|
$
|
13,615
|
|
Changes in the period:
|
|
||
Changes in the estimated transaction price allocated to performance obligations satisfied in prior periods
|
374
|
|
|
Performance obligations satisfied from new activities in the period - contract revenue
|
46,605
|
|
|
Total revenue
|
$
|
60,594
|
|
|
2019
|
|
2020
|
|
2021
|
|
2022 and Thereafter
|
|
Total
|
||||||||||
Product Revenue
|
$
|
2,201
|
|
|
$
|
1,729
|
|
|
$
|
1,623
|
|
|
$
|
—
|
|
|
$
|
5,553
|
|
Research and development revenue
|
2,735
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2,735
|
|
|||||
Total revenues
|
$
|
4,936
|
|
|
$
|
1,729
|
|
|
$
|
1,623
|
|
|
$
|
—
|
|
|
$
|
8,288
|
|
|
Year Ended December 31, 2018
|
||||||||||
|
As reported
|
|
Adjustments
|
|
Balances without adoption of
ASC 606
|
||||||
Revenues:
|
|
|
|
|
|
||||||
Product revenue
|
$
|
25,590
|
|
|
$
|
(3,422
|
)
|
|
$
|
22,168
|
|
Research and development revenue
|
35,004
|
|
|
(1,609
|
)
|
|
33,395
|
|
|||
Total revenues
|
60,594
|
|
|
(5,031
|
)
|
|
55,563
|
|
|||
Costs and operating expenses:
|
|
|
|
|
|
||||||
Cost of product revenue
|
12,620
|
|
|
(285
|
)
|
|
12,335
|
|
|||
Research and development
|
29,978
|
|
|
(196
|
)
|
|
29,782
|
|
|||
Selling, general and administrative
|
29,291
|
|
|
—
|
|
|
29,291
|
|
|||
Total costs and operating expenses
|
71,889
|
|
|
(481
|
)
|
|
71,408
|
|
|||
Loss from operations
|
(11,295
|
)
|
|
(4,550
|
)
|
|
(15,845
|
)
|
|||
Interest income
|
671
|
|
|
—
|
|
|
671
|
|
|||
Other expenses
|
(291
|
)
|
|
—
|
|
|
(291
|
)
|
|||
Loss before income taxes
|
(10,915
|
)
|
|
(4,550
|
)
|
|
(15,465
|
)
|
|||
Provision for (benefit from) income taxes
|
(37
|
)
|
|
—
|
|
|
(37
|
)
|
|||
Net loss
|
$
|
(10,878
|
)
|
|
$
|
(4,550
|
)
|
|
$
|
(15,428
|
)
|
|
|
|
|
|
|
|
|
|
|||
Net loss per share, basic and diluted
|
$
|
(0.21
|
)
|
|
$
|
(0.09
|
)
|
|
$
|
(0.30
|
)
|
Weighted average common shares used in computing net loss per share, basic and diluted
|
52,205
|
|
|
|
|
52,205
|
|
|
December 31, 2018
|
||||||||||
|
As reported
|
|
Adjustments
|
|
Balances without adoption of
ASC 606
|
||||||
Assets
|
|
|
|
|
|
||||||
Accounts receivable
|
$
|
11,551
|
|
|
$
|
(1,253
|
)
|
|
$
|
10,298
|
|
Unbilled receivables, current
|
1,916
|
|
|
(1,916
|
)
|
|
—
|
|
|||
Contract assets
|
35
|
|
|
(35
|
)
|
|
—
|
|
|||
Inventories
|
589
|
|
|
1
|
|
|
590
|
|
|||
Unbilled receivables, non-current
|
786
|
|
|
(786
|
)
|
|
—
|
|
|||
Other non-current assets
|
265
|
|
|
(42
|
)
|
|
223
|
|
|||
Liabilities
|
|
|
|
|
|
||||||
Other accrued liabilities
|
4,855
|
|
|
(520
|
)
|
|
4,335
|
|
|||
Deferred revenue - current
|
4,936
|
|
|
(1,574
|
)
|
|
3,362
|
|
|||
Deferred revenue - non-current
|
3,352
|
|
|
(1,445
|
)
|
|
1,907
|
|
|||
Stockholders' equity
|
|
|
|
|
|
|
|
|
|||
Accumulated deficit
|
(330,474
|
)
|
|
(492
|
)
|
|
(330,966
|
)
|
|
Year Ended December 31,
|
|||||||
|
2018
|
|
2017
|
|
2016
|
|||
Shares issuable under Equity Incentive Plan
|
6,339
|
|
|
6,882
|
|
|
5,567
|
|
Shares issuable upon the conversion of warrants
|
—
|
|
|
—
|
|
|
73
|
|
Total anti-dilutive securities
|
6,339
|
|
|
6,882
|
|
|
5,640
|
|
|
December 31, 2018
|
||||||||||||||||
|
Adjusted Cost
|
|
Gross Unrealized Gains
(3)
|
|
Gross Unrealized Losses (3)
|
|
Estimated
Fair Value
|
|
Average
Contractual
Maturities
|
||||||||
|
|
|
(in days)
|
||||||||||||||
Money market funds
(1)
|
$
|
31,225
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
31,225
|
|
|
n/a
|
Common shares of CO
2
Solutions
(2)
|
563
|
|
|
25
|
|
|
—
|
|
|
588
|
|
|
n/a
|
||||
Total
|
$
|
31,788
|
|
|
$
|
25
|
|
|
$
|
—
|
|
|
$
|
31,813
|
|
|
|
|
December 31, 2017
|
||||||||||||||||
|
Adjusted Cost
|
|
Gross Unrealized Gains (3)
|
|
Gross Unrealized Losses (3)
|
|
Estimated
Fair Value
|
|
Average
Contractual
Maturities
|
||||||||
|
|
|
(in days)
|
||||||||||||||
Money market funds
(1)
|
$
|
6,778
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
6,778
|
|
|
n/a
|
Common shares of CO
2
Solutions
(2)
|
563
|
|
|
108
|
|
|
—
|
|
|
671
|
|
|
n/a
|
||||
Total
|
$
|
7,341
|
|
|
$
|
108
|
|
|
$
|
—
|
|
|
$
|
7,449
|
|
|
|
|
December 31, 2018
|
||||||||||||||
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
||||||||
Money market funds
|
$
|
31,225
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
31,225
|
|
Common shares of CO
2
Solutions
|
588
|
|
|
—
|
|
|
—
|
|
|
588
|
|
||||
Total
|
$
|
31,813
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
31,813
|
|
|
December 31, 2017
|
||||||||||||||
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
||||||||
Money market funds
|
$
|
6,778
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
6,778
|
|
Common shares of CO
2
Solutions
|
—
|
|
|
671
|
|
|
—
|
|
|
671
|
|
||||
Total
|
$
|
6,778
|
|
|
$
|
671
|
|
|
$
|
—
|
|
|
$
|
7,449
|
|
|
December 31,
|
||||||||||
|
2018
|
|
2017
|
|
2016
|
||||||
Allowance - beginning of period
|
$
|
(34
|
)
|
|
$
|
(421
|
)
|
|
$
|
(421
|
)
|
Write-offs and other
(1)
|
—
|
|
|
387
|
|
|
—
|
|
|||
Allowance - end of period
|
$
|
(34
|
)
|
|
$
|
(34
|
)
|
|
$
|
(421
|
)
|
|
December 31,
|
||||||
|
2018
|
|
2017
|
||||
Laboratory equipment
(1)
|
$
|
21,328
|
|
|
$
|
19,777
|
|
Leasehold improvements
|
10,359
|
|
|
10,327
|
|
||
Computer equipment and software
|
3,954
|
|
|
3,695
|
|
||
Office equipment and furniture
|
1,272
|
|
|
1,185
|
|
||
Construction in progress
(2)
|
939
|
|
|
85
|
|
||
Property and equipment
|
37,852
|
|
|
35,069
|
|
||
Less: accumulated depreciation and amortization
|
(33,093
|
)
|
|
(32,254
|
)
|
||
Property and equipment, net
|
$
|
4,759
|
|
|
$
|
2,815
|
|
|
December 31,
|
||||||
|
2018
|
|
2017
|
||||
Accrued purchases
|
$
|
1,492
|
|
|
$
|
941
|
|
Accrued professional and outside service fees
|
2,020
|
|
|
2,393
|
|
||
Deferred rent
|
343
|
|
|
258
|
|
||
Lease incentive obligation
|
425
|
|
|
425
|
|
||
Other
|
575
|
|
|
345
|
|
||
Total
|
$
|
4,855
|
|
|
$
|
4,362
|
|
|
Year Ended December 31,
|
||||||||||
|
2018
|
|
2017
|
|
2016
|
||||||
Research and development
|
$
|
2,055
|
|
|
$
|
1,444
|
|
|
$
|
1,033
|
|
Selling, general and administrative
|
5,834
|
|
|
5,647
|
|
|
4,640
|
|
|||
Total
|
$
|
7,889
|
|
|
$
|
7,091
|
|
|
$
|
5,673
|
|
|
Year Ended December 31,
|
|||||||
|
2018
|
|
2017
|
|
2016
|
|||
Expected life (years)
|
5.6
|
|
|
5.4
|
|
|
5.3
|
|
Volatility
|
60.0
|
%
|
|
62.2
|
%
|
|
64.2
|
%
|
Risk-free interest rate
|
2.7
|
%
|
|
2.0
|
%
|
|
1.3
|
%
|
Expected dividend yield
|
0.0
|
%
|
|
0.0
|
%
|
|
0.0
|
%
|
|
Number
of Shares |
|
Weighted
Average Exercise Price Per Share |
|||
|
(In Thousands)
|
|
|
|||
Outstanding at December 31, 2015
|
3,918
|
|
|
$
|
4.49
|
|
Granted
|
971
|
|
|
$
|
4.16
|
|
Exercised
|
(398
|
)
|
|
$
|
2.60
|
|
Forfeited/Expired
|
(601
|
)
|
|
$
|
5.76
|
|
Outstanding at December 31, 2016
|
3,890
|
|
|
$
|
4.40
|
|
Granted
|
856
|
|
|
$
|
4.57
|
|
Exercised
|
(86
|
)
|
|
$
|
3.10
|
|
Forfeited/Expired
|
(81
|
)
|
|
$
|
7.72
|
|
Outstanding at December 31, 2017
|
4,579
|
|
|
$
|
4.40
|
|
Granted
|
645
|
|
|
$
|
9.56
|
|
Exercised
|
(772
|
)
|
|
$
|
5.56
|
|
Forfeited/Expired
|
(340
|
)
|
|
$
|
6.66
|
|
Outstanding at December 31, 2018
|
4,112
|
|
|
$
|
4.81
|
|
|
|
|
|
|||
Exercisable at December 31, 2018
|
2,876
|
|
|
$
|
3.83
|
|
Vested and expected to vest at December 31, 2018
|
3,954
|
|
|
$
|
4.69
|
|
|
Number
of Shares |
|
Weighted
Average Exercise Price Per Share |
|
Weighted
Average Remaining Contractual Term |
|
Aggregate Intrinsic
Value |
|||||
|
(In Thousands)
|
|
|
|
(In Years)
|
|
(In Thousands)
|
|||||
Outstanding at December 31, 2018
|
4,112
|
|
|
$
|
4.81
|
|
|
6.23
|
|
$
|
48,927
|
|
Exercisable at December 31, 2018
|
2,876
|
|
|
$
|
3.83
|
|
|
5.25
|
|
$
|
37,005
|
|
Vested and expected to vest at December 31, 2018
|
3,954
|
|
|
$
|
4.69
|
|
|
6.13
|
|
$
|
47,503
|
|
|
Number
of Shares |
|
Weighted Average
Grant Date Fair Value Per Share |
|||
|
(In Thousands)
|
|
|
|||
Non-vested balance at December 31, 2015
|
480
|
|
|
$
|
3.29
|
|
Granted
|
185
|
|
|
$
|
4.21
|
|
Vested
|
(435
|
)
|
|
$
|
3.40
|
|
Non-vested balance at December 31, 2016
|
230
|
|
|
$
|
3.82
|
|
Granted
|
143
|
|
|
$
|
4.75
|
|
Vested
|
(214
|
)
|
|
$
|
3.81
|
|
Non-vested balance at December 31, 2017
|
159
|
|
|
$
|
4.68
|
|
Granted
|
47
|
|
|
$
|
14.35
|
|
Vested
|
(151
|
)
|
|
$
|
4.71
|
|
Non-vested balance at December 31, 2018
|
55
|
|
|
$
|
12.83
|
|
|
Number
of Shares |
|
Weighted Average
Grant Date Fair Value Per Share |
|||
|
(In Thousands)
|
|
|
|||
Non-vested balance at January 1, 2016
|
545
|
|
|
$
|
3.15
|
|
Granted
|
330
|
|
|
$
|
4.10
|
|
Vested
|
(243
|
)
|
|
$
|
3.11
|
|
Forfeited/Expired
|
(15
|
)
|
|
$
|
2.74
|
|
Non-vested balance at December 31, 2016
|
617
|
|
|
$
|
3.69
|
|
Granted
|
275
|
|
|
$
|
4.22
|
|
Vested
|
(302
|
)
|
|
$
|
3.40
|
|
Forfeited/Expired
|
(30
|
)
|
|
$
|
4.12
|
|
Non-vested balance at December 31, 2017
|
560
|
|
|
$
|
4.08
|
|
Granted
|
86
|
|
|
$
|
10.56
|
|
Vested
|
(290
|
)
|
|
$
|
4.09
|
|
Forfeited/Expired
|
(8
|
)
|
|
$
|
4.73
|
|
Non-vested balance at December 31, 2018
|
348
|
|
|
$
|
5.66
|
|
|
Number
of Shares |
|
Weighted Average
Grant Date Fair Value Per Share |
|||
|
(In Thousands)
|
|
|
|||
Non-vested balance at January 1, 2016
|
989
|
|
|
$
|
2.94
|
|
Granted
|
629
|
|
|
$
|
4.10
|
|
Vested
|
(482
|
)
|
|
$
|
2.89
|
|
Forfeited/Expired
|
(305
|
)
|
|
$
|
2.82
|
|
Non-vested balance at January 1, 2017
|
831
|
|
|
$
|
3.88
|
|
Granted
|
276
|
|
|
$
|
4.25
|
|
Vested
|
(651
|
)
|
|
$
|
3.84
|
|
Forfeited/Expired
|
(27
|
)
|
|
$
|
3.65
|
|
Non-vested balance at January 1, 2018
|
429
|
|
|
$
|
4.20
|
|
Granted
|
306
|
|
|
$
|
6.71
|
|
Vested
|
(495
|
)
|
|
$
|
4.16
|
|
Non-vested balance at December 31, 2018
|
240
|
|
|
$
|
7.48
|
|
|
Year Ended December 31,
|
|||||||
|
2018
|
|
2017
|
|
2016
|
|||
Expected life (years)
|
5.63
|
|
|
5.33
|
|
|
—
|
|
Volatility
|
60.3
|
%
|
|
62.3
|
%
|
|
—
|
|
Risk-free interest rate
|
5.6
|
%
|
|
5.3
|
%
|
|
—
|
|
Expected dividend yield
|
0.0
|
%
|
|
0.0
|
%
|
|
—
|
|
|
Number of Shares
|
|
Weighted Average Grant Date Fair Value Per Share
|
|||
|
(in thousands)
|
|
|
|||
Outstanding at December 31, 2016
|
—
|
|
|
$
|
—
|
|
Granted
|
1,720
|
|
|
$
|
2.54
|
|
Outstanding at December 31, 2017
|
1,720
|
|
|
$
|
2.54
|
|
Granted
|
1,200
|
|
|
$
|
5.02
|
|
Exercised
|
(84
|
)
|
|
$
|
2.54
|
|
Forfeited
|
(1,254
|
)
|
|
$
|
3.73
|
|
Outstanding at December 31, 2018
|
1,582
|
|
|
$
|
3.47
|
|
|
Number
of Shares |
|
Weighted
Average Exercise Price Per Share |
|
Weighted
Average Remaining Contractual Term |
|
Aggregate Intrinsic
Value |
|||||
|
(In Thousands)
|
|
|
|
(In Years)
|
|
(In Thousands)
|
|||||
Exercisable at December 31, 2018
|
493
|
|
|
$
|
4.60
|
|
|
5.60
|
|
$
|
5,968
|
|
Vested and expected to vest at December 31, 2018
|
1,582
|
|
|
$
|
6.24
|
|
|
5.44
|
|
$
|
16,553
|
|
|
Year Ended December 31,
|
||||||||||
|
2018
|
|
2017
|
|
2016
|
||||||
United States
|
$
|
(10,653
|
)
|
|
$
|
(22,994
|
)
|
|
$
|
(8,174
|
)
|
Foreign
|
(262
|
)
|
|
79
|
|
|
(424
|
)
|
|||
Loss before provision for income taxes
|
$
|
(10,915
|
)
|
|
$
|
(22,915
|
)
|
|
$
|
(8,598
|
)
|
|
Year Ended December 31,
|
||||||||||
|
2018
|
|
2017
|
|
2016
|
||||||
Current provision (benefit):
|
|
|
|
|
|
||||||
Federal
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
State
|
5
|
|
|
5
|
|
|
5
|
|
|||
Foreign
|
(13
|
)
|
|
64
|
|
|
(14
|
)
|
|||
Total current provision (benefit)
|
(8
|
)
|
|
69
|
|
|
(9
|
)
|
|||
Deferred provision (benefit):
|
|
|
|
|
|
||||||
Federal
|
—
|
|
|
—
|
|
|
—
|
|
|||
State
|
—
|
|
|
—
|
|
|
—
|
|
|||
Foreign
|
(29
|
)
|
|
12
|
|
|
(31
|
)
|
|||
Total deferred provision (benefit)
|
(29
|
)
|
|
12
|
|
|
(31
|
)
|
|||
Provision for (benefit from) income taxes
|
$
|
(37
|
)
|
|
$
|
81
|
|
|
$
|
(40
|
)
|
|
Year Ended December 31,
|
||||||||||
|
2018
|
|
2017
|
|
2016
|
||||||
Tax benefit at federal statutory rate
|
$
|
(2,292
|
)
|
|
$
|
(7,791
|
)
|
|
$
|
(2,924
|
)
|
State taxes
|
222
|
|
|
48
|
|
|
127
|
|
|||
Research and development credits
|
(499
|
)
|
|
(399
|
)
|
|
(161
|
)
|
|||
Foreign operations taxed at different rates
|
(17
|
)
|
|
(2
|
)
|
|
30
|
|
|||
Stock-based compensation
|
(2,587
|
)
|
|
(216
|
)
|
|
327
|
|
|||
Other nondeductible items
|
(3
|
)
|
|
326
|
|
|
405
|
|
|||
Executive compensation
|
838
|
|
|
73
|
|
|
255
|
|
|||
Change in valuation allowance
|
4,301
|
|
|
(26,058
|
)
|
|
1,901
|
|
|||
Change in statutory tax rate
|
—
|
|
|
34,100
|
|
|
—
|
|
|||
Provision for (benefit from) income taxes
|
$
|
(37
|
)
|
|
$
|
81
|
|
|
$
|
(40
|
)
|
|
December 31,
|
||||||
|
2018
|
|
2017
|
||||
Deferred tax assets:
|
|
|
|
||||
Net operating losses
|
$
|
60,455
|
|
|
$
|
53,901
|
|
Credits
|
7,174
|
|
|
6,221
|
|
||
Deferred revenues
|
1,879
|
|
|
3,334
|
|
||
Stock-based compensation
|
2,967
|
|
|
2,872
|
|
||
Reserves and accruals
|
1,876
|
|
|
2,028
|
|
||
Depreciation
|
1,376
|
|
|
1,573
|
|
||
Intangible assets
|
2,557
|
|
|
3,172
|
|
||
Capital losses
|
576
|
|
|
576
|
|
||
Unrealized gain/loss
|
297
|
|
|
295
|
|
||
Other assets
|
83
|
|
|
78
|
|
||
Total deferred tax assets:
|
79,240
|
|
|
74,050
|
|
||
Deferred tax liabilities:
|
|
|
|
||||
Other
|
(64
|
)
|
|
(115
|
)
|
||
Total deferred tax liabilities:
|
(64
|
)
|
|
(115
|
)
|
||
Valuation allowance
|
(79,222
|
)
|
|
(74,010
|
)
|
||
Net deferred tax liabilities
|
$
|
(46
|
)
|
|
$
|
(75
|
)
|
|
December 31, 2018
|
||||
|
Amount
|
|
Expiration
Years
|
||
Net operating losses, federal
|
$
|
254,208
|
|
|
2022-2038
|
Net operating losses, state
|
115,420
|
|
|
2018-2038
|
|
Tax credits, federal
|
7,430
|
|
|
2022-2038
|
|
Tax credits, state
|
9,121
|
|
|
Do not expire
|
|
Net operating losses, foreign
|
383
|
|
|
Various
|
|
Rollforward Table (at Gross): As of
|
||||||||||
|
December 31,
|
||||||||||
|
2018
|
|
2017
|
|
2016
|
||||||
Balance at beginning of year
|
$
|
9,422
|
|
|
$
|
8,566
|
|
|
$
|
8,152
|
|
Additions based on tax positions related to current year
|
1,087
|
|
|
880
|
|
|
459
|
|
|||
Reductions to tax provision of prior years
|
(529
|
)
|
|
(24
|
)
|
|
(45
|
)
|
|||
Balance at end of year
|
$
|
9,980
|
|
|
$
|
9,422
|
|
|
$
|
8,566
|
|
Years ending December 31,
|
Capital Leases
|
|
Operating Leases
|
||||
2019
|
$
|
252
|
|
|
$
|
3,280
|
|
2020
|
61
|
|
|
712
|
|
||
2021
|
—
|
|
|
490
|
|
||
2022
|
—
|
|
|
41
|
|
||
2023
|
—
|
|
|
—
|
|
||
Total minimum lease payments
(1)
|
313
|
|
|
$
|
4,523
|
|
|
Less: amount representing interest
|
(10
|
)
|
|
|
|||
Present value of capital lease obligations
|
303
|
|
|
|
|||
Less: current portion
|
(242
|
)
|
|
|
|||
Long-term portion of capital leases
|
$
|
61
|
|
|
|
(1)
|
Minimum payments have not been reduced by future minimum sublease rentals of
$0.9 million
to be received under non-cancellable subleases.
|
Other Commitment Agreement Type
|
Agreement Date
|
|
Future Minimum Payment
|
||
Manufacture and supply agreement with expected future payment date of December, 2022
|
April 2016
|
|
$
|
1,458
|
|
Service agreement for stability study
|
July 2017
|
|
331
|
|
|
Service agreement for clinical trial
|
December 2017
|
|
1,258
|
|
|
Total other commitments
|
|
|
$
|
3,047
|
|
|
Term Debt
|
|
Revolving Line of Credit
|
Through and including the first anniversary of the funding date of the first Term Debt drawn
|
2.0%
|
|
|
After the first anniversary of the funding date of the first Term Debt drawn and before the maturity date
|
1.0%
|
|
|
On the earliest to occur of the maturity date, the acceleration of Term Debt drawn or prepayment of Term Debt drawn
|
5.5%
|
|
|
Through and including the first anniversary of the closing date
|
|
|
3.0%
|
After the first anniversary of the closing date through and including the second anniversary of the closing date
|
|
|
2.0%
|
After the second anniversary of the closing date through and including the third anniversary of the closing date
|
|
|
1.0%
|
|
|
Year Ended December 31, 2018
|
|
Year Ended December 31, 2017
|
||||||||||||||||||||
|
|
Performance Enzymes
|
|
Novel Biotherapeutics
|
|
Total
|
|
Performance Enzymes
|
|
Novel Biotherapeutics
|
|
Total
|
||||||||||||
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Product revenue
|
|
$
|
25,590
|
|
|
$
|
—
|
|
|
$
|
25,590
|
|
|
$
|
26,685
|
|
|
$
|
—
|
|
|
$
|
26,685
|
|
Research and development revenue
|
|
21,483
|
|
|
13,521
|
|
|
35,004
|
|
|
15,648
|
|
|
7,691
|
|
|
23,339
|
|
||||||
Total revenues
|
|
47,073
|
|
|
13,521
|
|
|
60,594
|
|
|
42,333
|
|
|
7,691
|
|
|
50,024
|
|
||||||
Costs and operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Cost of product revenue
|
|
12,620
|
|
|
—
|
|
|
12,620
|
|
|
14,327
|
|
|
—
|
|
|
14,327
|
|
||||||
Research and development
(1)
|
|
18,924
|
|
|
10,185
|
|
|
29,109
|
|
|
16,847
|
|
|
12,107
|
|
|
28,954
|
|
||||||
Selling, general and administrative
|
|
7,538
|
|
|
771
|
|
|
8,309
|
|
|
7,371
|
|
|
—
|
|
|
7,371
|
|
||||||
Total segment costs and operating expenses
|
|
39,082
|
|
|
10,956
|
|
|
50,038
|
|
|
38,545
|
|
|
12,107
|
|
|
50,652
|
|
||||||
Income (loss) from operations
|
|
$
|
7,991
|
|
|
$
|
2,565
|
|
|
$
|
10,556
|
|
|
$
|
3,788
|
|
|
$
|
(4,416
|
)
|
|
$
|
(628
|
)
|
Corporate costs
(2)
|
|
|
|
|
|
(20,324
|
)
|
|
|
|
|
|
(21,245
|
)
|
||||||||||
Depreciation
|
|
|
|
|
|
(1,147
|
)
|
|
|
|
|
|
(1,042
|
)
|
||||||||||
Loss before income taxes
|
|
|
|
|
|
$
|
(10,915
|
)
|
|
|
|
|
|
$
|
(22,915
|
)
|
|
|
2018
|
|
2017
|
||||||||||||||||||||
|
|
Performance Enzymes
|
|
Novel Biotherapeutics
|
|
Total
|
|
Performance Enzymes
|
|
Novel Biotherapeutics
|
|
Total
|
||||||||||||
Stock-based compensation
|
|
$
|
2,591
|
|
|
$
|
338
|
|
|
$
|
2,929
|
|
|
$
|
2,306
|
|
|
$
|
208
|
|
|
$
|
2,514
|
|
|
Percentage of Total Revenues
For The Years Ended December 31,
|
|||||||
|
2018
|
|
2017
|
|
2016
|
|||
Merck
|
29
|
%
|
|
28
|
%
|
|
47
|
%
|
Nestlé Health Science
|
22
|
%
|
|
15
|
%
|
|
*
|
|
Tate & Lyle
|
13
|
%
|
|
11
|
%
|
|
*
|
|
Novartis
|
*
|
|
|
14
|
%
|
|
*
|
|
GSK
|
*
|
|
|
*
|
|
|
22
|
%
|
|
Percentage of Accounts Receivables
As Of December 31,
|
||||
|
2018
|
|
2017
|
||
Merck
|
37
|
%
|
|
31
|
%
|
Nestlé Health Science
|
17
|
%
|
|
*
|
|
Tate & Lyle
|
*
|
|
|
16
|
%
|
Novartis
|
11
|
%
|
|
15
|
%
|
Kyorin Pharmaceutical Co Ltd
|
16
|
%
|
|
*
|
|
Exela PharmaSci, Inc.
|
*
|
|
|
14
|
%
|
|
December 31,
|
||||||
|
2018
|
|
2017
|
||||
Long-lived assets
|
|
|
|
||||
United States
|
$
|
4,759
|
|
|
$
|
2,815
|
|
|
|
|
December 31, 2018
|
||||||||||
|
|
|
Performance Enzymes
|
|
Novel Biotherapeutics
|
|
Total
|
||||||
|
|
|
|
|
|
|
|
||||||
Goodwill
|
|
|
$
|
2,463
|
|
|
$
|
778
|
|
|
$
|
3,241
|
|
|
Quarter Ended
(1)
|
||||||||||||||||||||||||||||||||
|
December 31, 2018
(3)
|
|
September 30,
2018 |
|
June 30,
2018 |
|
March 31,
2018 |
|
|
|
December 31, 2017
(3)
|
|
September 30,
2017 |
|
June 30,
2017 |
|
March 31,
2017 |
||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
Product revenue
|
$
|
7,299
|
|
|
$
|
8,405
|
|
|
$
|
3,723
|
|
|
$
|
6,163
|
|
|
|
|
$
|
7,551
|
|
|
$
|
6,948
|
|
|
$
|
6,600
|
|
|
$
|
5,586
|
|
Research and development revenue
|
8,769
|
|
|
8,541
|
|
|
9,815
|
|
|
7,879
|
|
|
|
|
14,171
|
|
|
3,036
|
|
|
3,747
|
|
|
2,385
|
|
||||||||
Total revenues
|
$
|
16,068
|
|
|
$
|
16,946
|
|
|
$
|
13,538
|
|
|
$
|
14,042
|
|
|
|
|
$
|
21,722
|
|
|
$
|
9,984
|
|
|
$
|
10,347
|
|
|
$
|
7,971
|
|
Costs and operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
Cost of product revenue
|
$
|
2,393
|
|
|
$
|
3,791
|
|
|
$
|
2,611
|
|
|
$
|
3,825
|
|
|
|
|
$
|
3,559
|
|
|
$
|
3,976
|
|
|
$
|
3,790
|
|
|
$
|
3,002
|
|
Research and development
|
7,513
|
|
|
7,917
|
|
|
7,370
|
|
|
7,178
|
|
|
|
|
9,417
|
|
|
8,055
|
|
|
6,348
|
|
|
5,839
|
|
||||||||
Selling, general and administrative
|
6,806
|
|
|
7,344
|
|
|
7,395
|
|
|
7,746
|
|
|
|
|
7,867
|
|
|
7,989
|
|
|
6,546
|
|
|
6,606
|
|
||||||||
Total costs and operating expenses
|
$
|
16,712
|
|
|
$
|
19,052
|
|
|
$
|
17,376
|
|
|
$
|
18,749
|
|
|
|
|
$
|
20,843
|
|
|
$
|
20,020
|
|
|
$
|
16,684
|
|
|
$
|
15,447
|
|
Income (loss) from operations
|
$
|
(644
|
)
|
|
$
|
(2,106
|
)
|
|
$
|
(3,838
|
)
|
|
$
|
(4,707
|
)
|
|
|
|
$
|
879
|
|
|
$
|
(10,036
|
)
|
|
$
|
(6,337
|
)
|
|
$
|
(7,476
|
)
|
Income (loss) before income taxes
|
$
|
(486
|
)
|
|
$
|
(1,987
|
)
|
|
$
|
(3,746
|
)
|
|
$
|
(4,696
|
)
|
|
|
|
$
|
919
|
|
|
$
|
(10,076
|
)
|
|
$
|
(6,322
|
)
|
|
$
|
(7,436
|
)
|
Net income (loss)
|
$
|
(461
|
)
|
|
$
|
(1,988
|
)
|
|
$
|
(3,735
|
)
|
|
$
|
(4,694
|
)
|
|
|
|
$
|
970
|
|
|
$
|
(10,226
|
)
|
|
$
|
(6,280
|
)
|
|
$
|
(7,460
|
)
|
Net income (loss) per share, basic
|
$
|
(0.01
|
)
|
|
$
|
(0.04
|
)
|
|
$
|
(0.07
|
)
|
|
$
|
(0.10
|
)
|
|
|
|
$
|
0.02
|
|
|
$
|
(0.21
|
)
|
|
$
|
(0.13
|
)
|
|
$
|
(0.18
|
)
|
Net income (loss) per share, diluted
|
$
|
(0.01
|
)
|
|
$
|
(0.04
|
)
|
|
$
|
(0.07
|
)
|
|
$
|
(0.10
|
)
|
|
|
|
$
|
0.02
|
|
|
$
|
(0.21
|
)
|
|
$
|
(0.13
|
)
|
|
$
|
(0.18
|
)
|
Weighted average common shares used in computing net income (loss) per share, basic
(2)
|
53,973
|
|
|
53,597
|
|
|
52,787
|
|
|
48,385
|
|
|
|
|
48,187
|
|
|
48,147
|
|
|
47,232
|
|
|
41,250
|
|
||||||||
Weighted average common shares used in computing net income (loss) per share, diluted
(2)
|
53,973
|
|
|
53,597
|
|
|
52,787
|
|
|
48,385
|
|
|
|
|
50,599
|
|
|
48,147
|
|
|
47,232
|
|
|
41,250
|
|
|
(1)
|
Amounts were computed independently for each quarter, and the sum of the quarters may not total the annual amounts due to rounding differences.
|
|
(2)
|
The full year net loss per share of common stock, basic and diluted, may not equal the sum of the quarters due to weighting of outstanding shares.
|
|
(3)
|
PSUs, PBOs, and cash bonus awards are granted to certain employees and executives and are subject to our performance in achieving pre-determined criteria approved by our board of directors. Based on the actual achievement of the annual goals, we updated the calculation of the annual expense in the fourth quarter which resulted in true-up adjustments of approximately $(0.5) million in 2018 and $0.1 million in 2017, primarily in selling, general and administrative expense.
|
1.
|
Financial Statements: See “Index to Consolidated Financial Statements” in Part II, Item 8 of this Annual Report on Form 10-K
|
2.
|
Exhibits: The exhibits listed in the accompanying index to exhibits are filed or incorporated by reference as part of this Annual Report on Form 10-K.
|
Exhibit
No.
|
|
Description
|
|
|
|
3.1
|
|
|
|
|
|
3.2
|
|
|
|
|
|
3.3
|
|
|
|
|
|
4.1
|
|
Reference is made to Exhibits 3.1 through 3.3.
|
|
|
|
4.2
|
|
|
|
|
|
10.1A*
|
|
|
|
|
|
10.1B*
|
|
|
|
|
|
10.1C*
|
|
|
|
|
|
10.1D*
|
|
|
|
|
|
10.1E
|
|
|
|
|
|
10.1F
|
|
|
|
|
|
10.1G
|
|
|
|
|
|
10.1H
|
|
|
|
|
|
10.2+*
|
|
|
|
|
|
10.3+*
|
|
|
|
|
|
10.4*
|
|
|
|
|
|
10.5A+*
|
|
|
|
Exhibit
No.
|
|
Description
|
10.5B+
|
|
|
|
|
|
10.5C+
|
|
|
|
|
|
10.6
|
|
|
|
|
|
10.7A†
|
|
|
|
|
|
10.7B
|
|
|
|
|
|
10.8A+
|
|
|
|
|
|
10.8B+
|
|
|
|
|
|
10.9+
|
|
|
|
|
|
10.10A+
|
|
|
|
|
|
10.10B+
|
|
|
|
|
|
10.10C+
|
|
|
|
|
|
10.10D+
|
|
|
|
|
|
10.10E+
|
|
|
|
|
|
10.11A†
|
|
|
|
|
|
10.11B†
|
|
|
|
|
|
10.11C
|
|
Exhibit
No.
|
|
Description
|
|
|
|
10.11D
|
|
|
|
|
|
10.11E
|
|
|
|
|
|
10.12A†
|
|
|
|
|
|
10.12B†
|
|
|
|
|
|
10.12C†
|
|
|
|
|
|
10.13†
|
|
|
|
|
|
10.14†
|
|
|
|
|
|
10.14A†
|
|
|
|
|
|
10.15†
|
|
|
|
|
|
10.15A†
|
|
|
|
|
|
10.15B†
|
|
|
|
|
|
10.15C†
|
|
|
|
|
|
10.15D†
|
|
|
|
|
|
12.1
|
|
|
|
|
|
21.1
|
|
|
|
|
|
23.1
|
|
|
|
|
|
24.1
|
|
Power of Attorney (see signature page to this Annual Report on Form 10-K).
|
|
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Exhibit
No.
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Description
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31.1
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31.2
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32.1**
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101
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The following materials from Registrant’s Annual Report on Form 10-K for the fiscal year ended December 31, 2018, formatted in Extensible Business Reporting Language (XBRL) includes: (i) Consolidated Balance Sheets at December 31, 2018 and December 31, 2017, (ii) Consolidated Statements of Income for the years ended December 31, 2018, December 31, 2017 and December 31, 2016, (iii) Consolidated Statements of Comprehensive Loss for the years ended December 31, 2018, December 31, 2017 and December 31, 2016, (iv) Consolidated Statements of Cash Flows for the years ended December 31, 2018, December 31, 2017 and December 31, 2016, (v) Consolidated Statements of Stockholders’ Equity for the years ended December 31, 2018, December 31, 2017 and December 31, 2016 and (vi) Notes to Consolidated Financial Statements.
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+
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Indicates a management contract or compensatory plan or arrangement.
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†
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Confidential treatment has been granted for certain information contained in this exhibit. Such information has been omitted and filed separately with the Securities and Exchange Commission.
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*
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Filed as exhibits to the registrant’s Registration Statement on Form S-1 (File No. 333-164044), effective April 21, 2010, and incorporated herein by reference.
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**
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Pursuant to Item 601(b)(32) of Regulation S-K this exhibit is furnished rather than filed with this report.
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CODEXIS, INC.
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Date:
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March 1, 2019
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By:
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/s/ John J. Nicols
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President and Chief Executive Officer
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(Principal Executive Officer)
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SIGNATURE
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TITLE
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DATE
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/s/ John J. Nicols
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President, Chief Executive Officer and Director (Principal Executive Officer)
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Date:
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March 1, 2019
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John J. Nicols
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/s/ Gordon T. B. Sangster
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Senior Vice President and Chief Financial Officer (Principal Financial and Accounting Officer)
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Date:
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March 1, 2019
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Gordon T. B. Sangster
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/s/ Bernard J. Kelley
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Chairman of the Board of Directors
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Date:
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March 1, 2019
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Bernard J. Kelley
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/s/ Thomas R. Baruch
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Chairman Emeritus, Director
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Date:
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March 1, 2019
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Thomas R. Baruch
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/s/ Pam P. Cheng
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Director
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Date:
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March 1, 2019
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Pam P. Cheng
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/s/ Byron L. Dorgan
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Director
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Date:
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March 1, 2019
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Byron L. Dorgan
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/s/ Kathleen S. Glaub
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Director
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Date:
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March 1, 2019
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Kathleen S. Glaub
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/s/ David V. Smith
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Director
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Date:
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March 1, 2019
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David V. Smith
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/s/ Dennis P. Wolf
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Director
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Date:
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March 1, 2019
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Dennis P. Wolf
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/s/ Patrick Y. Yang
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Director
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Date:
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March 1, 2019
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Patrick Y. Yang
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By:
/s/ Claudio Kuoni
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(Signature)
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Re:
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Section 7.3.2 of the Global Development Option and License Agreement (“GDOLA”) dated October 12, 2017, as amended, by and between Nestec Ltd. (“NHSc”) and Codexis, Inc. (“Codexis”)
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Cc:
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[***]
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1.
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Additions and changes made to the contract in this Amendment.
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1.01
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Section 3.2.3 shall be amended to the following:
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1.02
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Exhibit 3.4.4 shall be amended to the following:
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1.
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Miscellaneous
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2.01
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Effect of Amendment; Joinder
. Except as expressly changed by this Amendment, the Agreement shall remain in full force and effect in accordance with its stated terms.
The Agreement and the Schedules and Exhibits thereto, as amended by this Amendment and all preceding amendments, set forth the entire understanding of the parties with respect to the subject matter thereof. There are no agreements, restrictions, promises, warranties, covenants or undertakings other than those expressly set forth or referred to therein. The Agreement and the Schedules and Exhibits thereto, as amended by this Amendment, supersede all prior agreements and undertakings between the parties with respect to such subject matter.
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2.02
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Counterparts
. This Amendment may be executed by the parties in separate counterparts, each of which when so executed and delivered is deemed an original. All such counterparts together constitute but one and the same instrument.
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2.03
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Definitions
. All capitalized terms used but not defined in this Amendment shall have the respective definitions assigned to such terms in the Agreement.
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Codexis Inc.
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Merck Sharp & Dohme Corp.
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By:___/s/ John J. Nicols_______________________
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By:__/s/ Karen L. MacNaul_______________________
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Name: John J. Nicols
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Name: Karen L. MacNaul on behalf of Joseph P. Miletich, M.D., Ph.D., SVP, Discovery Research, MRL
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Title: President and CEO
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Title: Executive Director, Business Development & Licensing - MRL
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Date: October 10, 2018
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Date: Oct 08, 2018
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Years Ended December 31,
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2014
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2015
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2016
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2017
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2018
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Fixed charges:
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Interest Expense
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—
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—
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14
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141
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84
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Total Fixed Charges
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14
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141
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84
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Earnings (deficiency) available for fixed charges:
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Pre-tax loss from continuing operations
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(19,327)
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(7,919)
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(8,598)
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(23,239
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)
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(10,878
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)
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add: Fixed Charges
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14
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141
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84
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Earnings (deficiency of earnings) available to cover fixed charges
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(19,327)
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(7,919)
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(8,584)
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(23,098
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)
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(10,794
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)
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Ratio of earnings to fixed charges (1)
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N/A
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N/A
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N/A
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N/A
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N/A
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(1)
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Our earnings were inadequate to cover fixed charges for the years ended December 31, 2014 through December 31, 2018.
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Name of Subsidiary
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State or Jurisdiction in which Incorporated or Organized
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Codexis Mayflower Holdings LLC
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Delaware
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1.
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I have reviewed this Annual Report on Form 10-K of Codexis, Inc.;
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2.
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Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
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3.
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Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
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4.
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The registrant's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
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(a)
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Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
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(b)
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Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
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(c)
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Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
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(d)
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Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
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5.
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The registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
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(a)
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All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
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(b)
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Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
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/s/John J. Nicols
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John J. Nicols
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President and Chief Executive Officer
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1.
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I have reviewed this Annual Report on Form 10-K of Codexis, Inc.;
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2.
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Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
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3.
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Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
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4.
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The registrant's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
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(a)
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Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
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(b)
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Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
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(c)
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Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
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(d)
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Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
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5.
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The registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
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(a)
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All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
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(b)
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Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
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/s/Gordon Sangster
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Gordon Sangster
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Senior Vice President and Chief Financial Officer
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•
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The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
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•
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The information in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
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/s/John J. Nicols
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John J. Nicols
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President and Chief Executive Officer
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/s/Gordon Sangster
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Gordon Sangster
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Senior Vice President and Chief Financial Officer
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