FORM 10-K
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IMMUNOMEDICS, INC.
|
(Exact name of registrant as specified in its charter)
|
Delaware
|
61-1009366
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(State of incorporation)
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(I.R.S. Employer Identification No.)
|
|
|
300 The American Road, Morris Plains, New Jersey
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07950
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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, $0.01 par value
|
|
Nasdaq Stock Market LLC
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Large Accelerated Filer
|
þ
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Accelerated Filer
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¨
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Non-Accelerated Filer
|
¨
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Smaller Reporting Company
|
¨
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Emerging Growth Company
|
¨
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|
|
1.
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Initiate clinical studies in second-line mTNBC as a monotherapy and in combination with PARP and checkpoint inhibitors in first line;
|
2.
|
Complete patient enrollment into the pivotal Phase 2 TROPHY-U01 study in metastatic UC;
|
3.
|
Launch a pivotal study in estrogen receptor-positive/HER2 negative metastatic breast cancer ("mBC"); and
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4.
|
Finalize commercial strategy in the European Union and complete licensing arrangement for territories outside the United States and Europe.
|
•
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A capping of the proportion of patients with stable brain metastasis to no more than 15% of the total enrollment;
|
•
|
An increase of the sample size from 328 to 488 patients, which will allow for progression-free survival (“PFS”) to be analyzed in patients without brain metastasis, while keeping intact the statistical power to analyze PFS in the overall population; and
|
•
|
Increased power for key secondary endpoints such as overall survival.
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Program & Product Group
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|
Targeted
Antigen/Description
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|
Patent
Expiration
|
|
Major
Jurisdictions
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Antibody-Drug Conjugates
|
|
Trop-2, CEA/CEACAM5 and HLA-DR
|
|
2023-2033
|
|
U.S., Europe, Japan
|
Subcutaneous Formulation
|
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All Antibodies
|
|
2032
|
|
U.S., Europe, Japan
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Epratuzumab
|
|
CD22
|
|
2018-2032
|
|
U.S., Europe, Japan
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Veltuzumab
|
|
CD20
|
|
2023-2029
|
|
U.S., Europe, Japan
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Milatuzumab
|
|
CD74
|
|
2018-2032
|
|
U.S., Europe, Japan
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IMMU-114
|
|
HLA-DR
|
|
2026
|
|
U.S., Europe, Japan
|
DNL
®
Program - (E1)-3s
|
|
Trop-2
|
|
2033
|
|
U.S.*
|
•
|
completion of preclinical laboratory tests and animal studies performed in accordance with the FDA’s current Good Laboratory Practices regulations;
|
•
|
submission to the FDA of an Investigational New Drug Application (“IND”) which must become effective before human clinical trials may begin and must be updated annually;
|
•
|
approval by an independent Institutional Review Board (“IRB”) the ethics committee at each clinical site before the trial is initiated;
|
•
|
performance of adequate and well-controlled clinical trials to establish the safety, purity and potency of the proposed biologic, and the safety and efficacy of the proposed drug for each indication;
|
•
|
preparation of and submission to the FDA of a BLA for a new biologic, after completion of all pivotal clinical trials;
|
•
|
satisfactory completion of an FDA Advisory Committee review, if applicable;
|
•
|
a determination by the FDA within 60 days of its receipt of a BLA to file the application for review;
|
•
|
satisfactory completion of an FDA pre-approval inspection of the manufacturing facilities to assess compliance with current Good Manufacturing Practice (“cGMP”) regulations; and
|
•
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FDA review and approval of a BLA for a new biologic, prior to any commercial marketing or sale of the product in the United States.
|
•
|
Phase 1 studies are designed to evaluate the safety, dosage tolerance, metabolism and pharmacologic actions of the investigational product in humans, the side effects associated with increasing doses, and if possible, to gain early evidence on effectiveness.
|
•
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Phase 2 includes controlled clinical trials conducted to preliminarily or further evaluate the effectiveness of the investigational product for a particular indication(s) in patients with the disease or condition under study, to determine dosage tolerance and optimal dosage, and to identify possible adverse side effects and safety risks associated with the product.
|
•
|
Phase 3 clinical trials are generally controlled clinical trials conducted in an expanded patient population generally at geographically dispersed clinical trial sites, and are intended to further evaluate dosage, clinical effectiveness and safety, to establish the overall benefit-risk relationship of the investigational product, and to provide an adequate basis for product approval.
|
•
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later-stage clinical trials may raise safety or efficacy concerns not readily apparent in earlier trials or fail to meet the primary endpoint;
|
•
|
unforeseen difficulties in manufacturing the product candidate in compliance with all regulatory requirements and in the quantities needed to complete the trial which may become cost-prohibitive;
|
•
|
we or any of our collaboration partners may experience delays in obtaining, or be unable to obtain, agreement for the conduct of our clinical trials from the FDA, IRBs, or other reviewing entities at clinical sites selected for participation in our clinical trials;
|
•
|
while underway, the continuation of clinical trials may be delayed, suspended or terminated due to modifications to the clinical trial’s protocols based on interim results obtained or changes required or conditions imposed by the FDA, an IRB, a data and safety monitoring board (“DSMB”), or any other regulatory authority;
|
•
|
our third-party contractors may fail to meet their contractual obligations to us in a timely manner;
|
•
|
the FDA or other regulatory authorities may impose a clinical hold, for example based an inspection of the clinical trial operations or trial sites;
|
•
|
we or any of our collaboration partners may suspend or cease trials in our or their sole discretion;
|
•
|
during the long trial process alternative therapies may become available which make further development of the product candidate impracticable; and
|
•
|
if we are unable to obtain the additional capital we need to fund all of the clinical trials we foresee, we may be forced to cancel or otherwise curtail such trials and other studies.
|
•
|
upfront payments, milestone payments, and payments for limited amounts of our antibodies received from licensing partners;
|
•
|
proceeds from the public and private sale of our equity or debt securities; and
|
•
|
limited product sales of LeukoScan
®
(which were discontinued during February 2018), licenses, grants and interest income from our investments.
|
•
|
the rate of progress of commercialization of sacituzumab govitecan in mTNBC and our ability to develop it for other cancers;
|
•
|
the rate at which we progress our research programs and the number of product candidates we have in preclinical and clinical development at any one time;
|
•
|
the cost of conducting clinical trials involving patients in the United States, Europe and possibly elsewhere;
|
•
|
our need to establish the manufacturing capabilities necessary to produce the quantities of our product candidates we project we will need;
|
•
|
the time and costs involved in obtaining FDA and foreign regulatory approvals;
|
•
|
the cost of first obtaining, and then defending, our patent claims and other intellectual property rights; and
|
•
|
our ability to enter into licensing and other collaborative agreements to help offset some of these costs.
|
•
|
the timing of our receipt of marketing approvals, the terms of such approvals and the countries in which such approvals are obtained;
|
•
|
the safety, efficacy, reliability and ease of administration of our product candidates;
|
•
|
the prevalence and severity of undesirable side effects and adverse events;
|
•
|
the extent of the limitations or warnings required by the FDA or comparable regulatory authorities in other countries to be contained in the labeling of our product candidates;
|
•
|
the clinical indications for which our product candidates are approved;
|
•
|
the availability and perceived advantages of alternative therapies;
|
•
|
any publicity related to our product candidates or those of our competitors;
|
•
|
the quality and price of competing products;
|
•
|
our ability to obtain third-party payor coverage and sufficient reimbursement;
|
•
|
the willingness of patients to pay out of pocket in the absence of third-party payor coverage; and
|
•
|
the selling efforts and commitment of our commercialization collaborators.
|
•
|
the Medicaid Drug Rebate Program requires pharmaceutical manufacturers to enter into and have in effect a national rebate agreement with the Secretary of the Department of Health and Human Services as a condition of Medicare Part B and Medicaid coverage of the manufacturer's outpatient drugs furnished to Medicaid patients. Effective in 2010, the ACA made several changes to the Medicaid Drug Rebate Program, including increasing pharmaceutical manufacturers' rebate liability by raising the minimum basic Medicaid rebate on most branded prescription drugs from 15.1% of average manufacturer price, or AMP, to 23.1% of AMP, establishing new methodologies by which AMP is calculated and rebates owed by manufacturers under the Medicaid Drug Rebate Program are collected for drugs that are inhaled, infused, instilled, implanted or injected, adding a new rebate calculation for "line extensions" (i.e., new formulations, such as extended release formulations) of solid oral dosage forms of branded products, expanding the universe of Medicaid utilization subject to drug rebates to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations, and expanding the population potentially eligible for Medicaid drug benefits;
|
•
|
the expansion of eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to additional individuals beginning in April 2010 and by adding new mandatory eligibility categories for certain individuals with income at or below 133.0% of the federal poverty level beginning in 2014, thereby potentially increasing both the volume of sales and manufacturers' Medicaid rebate liability;
|
•
|
in order for a pharmaceutical product to receive federal reimbursement under the Medicare Part B and Medicaid programs or to be sold directly to United States government agencies, the manufacturer must extend discounts to
|
•
|
the ACA imposed a requirement on manufacturers of branded drugs to provide a 50% (and 70% commencing on January 1, 2019) discount off the negotiated price of branded drugs dispensed to Medicare Part D patients in the coverage gap (i.e., the donut hole);
|
•
|
the ACA imposed an annual, nondeductible fee on any entity that manufactures or imports certain branded prescription drugs, apportioned among these entities according to their market share in certain government healthcare programs, although this fee would not apply to sales of certain products approved exclusively for orphan indications;
|
•
|
the ACA implemented the Physician Payments Sunshine Act;
|
•
|
the ACA requires annual reporting of drug samples that manufacturers and distributors provide to physicians;
|
•
|
the ACA expanded healthcare fraud and abuse laws in the United States, including the False Claims Act and the federal Anti-Kickback Statute, new government investigative powers and enhanced penalties for non-compliance;
|
•
|
the ACA established a licensing framework for follow-on biologics;
|
•
|
a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in and conduct comparative clinical effectiveness research, along with the funding for such research. The research conducted by the Patient-Centered Outcomes Research Institute may affect the market for certain pharmaceutical products by influencing decisions relating to coverage and reimbursement rates; and
|
•
|
the ACA established the Center for Medicare and Medicaid Innovation within the Centers for Medicare & Medicaid Center, or Innovation Center, to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drug spending. The Innovation Center has been funded through 2019, and funding will be automatically renewed for each 10-year budget window thereafter.
|
•
|
clinical development is a long, expensive and uncertain process; delay and failure can occur at any stage of our clinical trials;
|
•
|
our clinical trials are dependent on patient enrollment and regulatory approvals; we do not know whether our planned trials will begin on time, or at all, or will be completed on schedule, or at all;
|
•
|
the FDA or other regulatory authorities may not approve a clinical trial protocol or may place a clinical trial on hold;
|
•
|
we rely on third parties, such as consultants, contract research organizations, medical institutions, and clinical investigators, to conduct clinical trials for our drug candidates and if we or any of our third-party contractors fail to comply with applicable regulatory requirements, such as cGCP requirements, the clinical data generated in our clinical trials may be deemed unreliable and the FDA, the EMA or comparable foreign regulatory authorities may require us to perform additional clinical trials;
|
•
|
if the clinical development process is completed successfully, our ability to derive revenues from the sale of therapeutics will depend on our first obtaining FDA or other comparable foreign regulatory approvals, each of which are subject to unique risks and uncertainties;
|
•
|
there is no assurance that we will receive FDA or corollary foreign approval for any of our product candidates for any indication; we are subject to government regulation for the commercialization of our product candidates;
|
•
|
we have not received regulatory approval in the United States for the commercial sale of any of our biologic product candidates;
|
•
|
even if one or more of our product candidates does obtain approval, regulatory authorities may approve such product candidate for fewer or more limited indications than we request, may not approve the price we intend to charge for our products, may grant approval contingent on the performance of costly post-marketing clinical trials, or may approve with a label that does not include the labeling claims necessary or desirable for the successful commercialization of that product candidate;
|
•
|
undesirable side effects caused by our product candidates could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or other comparable foreign authorities;
|
•
|
later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with our third-party manufacturers or manufacturing processes, or failure to comply with the regulatory requirements of FDA and other applicable United States and foreign regulatory authorities could subject us to administrative or judicially imposed sanctions;
|
•
|
although several of our product candidates have received orphan drug designation in the United States and the EU for particular indications, we may not receive orphan drug exclusivity for any or all of those product candidates or indications upon approval, and even if we do obtain orphan drug exclusivity, that exclusivity may not effectively protect the product from competition;
|
•
|
even if one or more of our product candidates is approved in the United States, it may not obtain the 12 years of exclusivity from biosimilars for which innovator biologics are eligible, and even if it does obtain such exclusivity, that exclusivity may not effectively protect the product from competition;
|
•
|
The federal Anti-Kickback Statute, which prohibits, among other things, persons and entities including pharmaceutical manufacturers from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, overtly or covertly, in case or in kind, to induce or reward, or in return for, or either the referral of an individual for, or the purchase, lease, order or recommendation of, an item or service reimbursable, in whole or in part, under a federal healthcare program, such as the Medicare or Medicaid programs. This statute has interpreted broadly to apply to, among other things, arrangements between pharmaceutical manufacturers on the one hand and prescribers, purchasers and formulary managers on the other hand. The term "remuneration" expressly includes kickbacks, bribes or rebates and also has been broadly interpreted to include anything of value, including, for example, gifts, discounts, waivers of payment, ownership interest and providing anything at less than its fair market value. There are a number of statutory exceptions and regulatory safe harbors protecting certain common activities from prosecution or other regulatory sanctions, however, the exceptions and safe harbors are drawn narrowly, and practices that do not fit squarely within an exception or safe harbor may be subject to scrutiny. The failure to meet all of the requirements of a particular applicable statutory exception or regulatory safe harbor does not make the conduct per se illegal under the federal Anti-Kickback Statute. Instead, the legality of the arrangement will be evaluated on a case-by-case basis based on a cumulative review of all of its facts and circumstances. Our practices may not meet all of the criteria for safe harbor protection from federal Anti-Kickback Statute liability in all cases. A person or entity does not need to have actual knowledge of the federal Anti-Kickback Statute or specific intent to violate it to have committed a violation. In addition, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act.
|
•
|
The federal civil and criminal false claims laws and civil monetary penalty laws, including the False Claims Act, which prohibits individuals or entities from, among other things, knowingly presenting, or causing to be presented, claims for payment to, or approval by, the federal government that are false, fictitious or fraudulent or knowingly making, using or causing to be made or used, a false record or statement material to a false or fraudulent claim to avoid, decrease or conceal an obligation to pay money to the federal government. As a result of a modification made by the Fraud Enforcement and Recovery Act of 2009, a claim includes "any request or demand" for money or property presented to the federal government. Although we do not submit claims directly to payors, manufacturers can be held liable under these laws if they are deemed to "cause" the submission of false or fraudulent claims by, for example, providing inaccurate billing or coding information to customers, promoting a product off-label, marketing products of sub-standard quality, or, as noted above, paying a kickback that results in a claim for items or services. In addition, our activities relating to the reporting of wholesaler or estimated retail prices for our products, the reporting of prices used to calculate Medicaid rebate information and other information affecting federal, state and third-party reimbursement for our products, and the sale and marketing of our products, are subject to scrutiny under this law. For example, several pharmaceutical and other healthcare companies have faced enforcement actions under these laws for allegedly inflating drug prices they report to pricing services, which in turn were used by the government to set Medicare and Medicaid reimbursement rates, and for allegedly providing free product to customers with the expectation that the customers would bill federal programs for the product. The False Claims Act also permits a private individual acting as a "whistleblower" to bring actions on behalf of the federal government alleging violations of the False Claims Act and to share in any monetary recovery. In addition, federal Anti-Kickback Statute violations and certain marketing practices, including off-label promotion, may also implicate the False Claims Act. Although the False Claims Act is a civil statute, conduct that results in a False Claims Act violation may also implicate various federal criminal statutes.
|
•
|
The federal physician payment transparency requirements, sometimes referred to as the "Physician Payments Sunshine Act," created under the United States Patient Protection and Affordable Care Act of 2010, as amended, or the ACA, and its implementing regulations, which requires applicable manufacturers of covered drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the State Children's Health Insurance Program (with certain exceptions) to annually report to the United States Department of Health and Human Services, or HHS, information related to certain payments or other transfers of value made or distributed to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, or to entities or individuals at the request of, or designated on behalf of, the physicians and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members.
|
•
|
Analogous state laws and regulations, such as state anti-kickback and false claims laws, which may apply to items or services reimbursed by any third-party payor, including commercial insurers, some state laws require pharmaceutical companies to comply with the pharmaceutical industry's voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government in addition to requiring drug manufacturers to report pricing and marketing information, including, among other things, information related to payments to physicians and other healthcare providers or marketing expenditures, state and local laws that require the registration of pharmaceutical sales representatives, and state laws governing the privacy and security of health information and the use of prescriber-identifiable data in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.
|
•
|
requiring the dedication of a substantial portion of our existing cash and marketable securities balances and, if available, future cash flow from operations to service our indebtedness, thereby reducing the amount of our expected cash flow available for other purposes, including capital expenditures;
|
•
|
increasing our vulnerability to general adverse economic and industry conditions;
|
•
|
limiting our ability to obtain additional financing;
|
•
|
limiting our ability to sell assets if deemed necessary;
|
•
|
limiting our flexibility in planning for, or reacting to, changes in our business and the industry in which we compete; and
|
•
|
placing us at a possible competitive disadvantage to less leveraged competitors and competitors that have better access to capital resources.
|
•
|
Announcements by us, any collaboration partners, any future alliance partners or our competitors of pre-clinical studies and clinical trial results, regulatory developments, technological innovations or new therapeutic products, product sales, new products or product candidates and product development timelines;
|
•
|
The formation or termination of corporate alliances;
|
•
|
Developments in patent or other proprietary rights by us or our respective competitors, including litigation;
|
•
|
Developments or disputes concerning our patent or other proprietary rights, and the issuance of patents in our field of business to others;
|
•
|
Government regulatory action;
|
•
|
Period-to-period fluctuations in the results of our operations; and
|
•
|
Developments and market conditions for emerging growth companies and biopharmaceutical companies, in general.
|
Location
|
|
Primary Usage
|
|
Approximate Square Feet
|
300 The American Road, Morris Plains, New Jersey
|
|
Office space, Research and Clinical Trial Management
|
|
85,000
|
400 The American Road, Morris Plains, New Jersey
|
|
Office space, warehouse
|
|
45,700
|
Fiscal Quarter Ended
|
|
High
|
|
Low
|
||||
September 30, 2016
|
|
$
|
3.43
|
|
|
$
|
2.09
|
|
December 31, 2016
|
|
4.10
|
|
|
2.02
|
|
||
March 31, 2017
|
|
7.15
|
|
|
3.30
|
|
||
June 30, 2017
|
|
9.04
|
|
|
5.00
|
|
||
|
|
|
|
|
||||
September 30, 2017
|
|
$
|
14.19
|
|
|
$
|
7.17
|
|
December 31, 2017
|
|
17.05
|
|
|
8.68
|
|
||
March 31, 2018
|
|
18.93
|
|
|
14.06
|
|
||
June 30, 2018
|
|
26.48
|
|
|
13.82
|
|
|
|
Indexed Returns (years ending)
|
||||||||||||||||
Company/Index
|
|
6/30/13
|
|
6/30/14
|
|
6/30/15
|
|
6/30/16
|
|
6/30/17
|
|
6/30/18
|
||||||
Immunomedics
|
|
100
|
|
|
67
|
|
|
75
|
|
|
43
|
|
|
162
|
|
|
435
|
|
Nasdaq Composite
|
|
100
|
|
|
125
|
|
|
134
|
|
|
137
|
|
|
163
|
|
|
187
|
|
Nasdaq Pharmaceutical
|
|
100
|
|
|
128
|
|
|
151
|
|
|
152
|
|
|
164
|
|
|
171
|
|
|
|
Fiscal Year Ended June 30,
|
||||||||||||||||||
(In thousands, except per share amounts)
|
|
2018
|
|
2017
|
|
2016
|
|
2015
|
|
2014
|
||||||||||
Total revenues
|
|
$
|
2,156
|
|
|
$
|
3,091
|
|
|
$
|
3,233
|
|
|
$
|
5,653
|
|
|
$
|
9,042
|
|
Total costs and expenses
|
|
143,203
|
|
|
82,241
|
|
|
62,241
|
|
|
51,873
|
|
|
44,622
|
|
|||||
Changes in fair market value of warrant liabilities
|
|
(108,636
|
)
|
|
(61,074
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Warrant related expenses
|
|
—
|
|
|
(7,649
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Interest expense
(1)
|
|
(23,255
|
)
|
|
(5,480
|
)
|
|
(5,480
|
)
|
|
(2,091
|
)
|
|
—
|
|
|||||
Interest and other income
|
|
5,493
|
|
|
431
|
|
|
338
|
|
|
246
|
|
|
56
|
|
|||||
Other financing expenses
|
|
(13,005
|
)
|
|
(347
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Insurance reimbursement
|
|
6,638
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Foreign currency transaction gain (loss), net
|
|
81
|
|
|
23
|
|
|
(40
|
)
|
|
(1
|
)
|
|
1
|
|
|||||
Loss before income tax
|
|
(273,731
|
)
|
|
(153,245
|
)
|
|
(64,190
|
)
|
|
(48,066
|
)
|
|
(35,523
|
)
|
|||||
Income tax (expense) benefit
|
|
(156
|
)
|
|
(21
|
)
|
|
5,054
|
|
|
(58
|
)
|
|
(8
|
)
|
|||||
Net loss
|
|
(273,887
|
)
|
|
(153,266
|
)
|
|
(59,136
|
)
|
|
(48,124
|
)
|
|
(35,531
|
)
|
|||||
Net loss attributable to noncontrolling interest
|
|
(50
|
)
|
|
(60
|
)
|
|
(99
|
)
|
|
(122
|
)
|
|
(105
|
)
|
|||||
Net loss attributable to Immunomedics, Inc. stockholders
|
|
$
|
(273,837
|
)
|
|
$
|
(153,206
|
)
|
|
$
|
(59,037
|
)
|
|
$
|
(48,002
|
)
|
|
$
|
(35,426
|
)
|
Loss per common share attributable to Immunomedics, Inc. stockholders (basic and diluted):
|
|
$
|
(1.78
|
)
|
|
$
|
(1.47
|
)
|
|
$
|
(0.62
|
)
|
|
$
|
(0.51
|
)
|
|
$
|
(0.42
|
)
|
Weighted average shares used to calculated loss per common share (basic and diluted)
|
|
153,475
|
|
|
104,536
|
|
|
94,770
|
|
|
93,315
|
|
|
84,632
|
|
|
|
As of June 30,
|
|||||||||||||||||
(In thousands)
|
|
2018
|
|
2017
|
|
2016
|
|
2015
|
|
2014
|
|||||||||
Cash, cash equivalents and marketable securities
|
|
$
|
638,802
|
|
|
154,902
|
|
|
$
|
50,628
|
|
|
$
|
99,618
|
|
|
$
|
41,833
|
|
Total Assets
|
|
664,173
|
|
|
162,573
|
|
|
56,950
|
|
|
105,780
|
|
|
47,486
|
|
||||
Liability related to sale of future royalties
|
|
202,007
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||
Convertible senior notes, net
|
|
19,763
|
|
|
98,084
|
|
|
97,354
|
|
|
96,625
|
|
|
—
|
|
||||
Warrant liabilities
|
|
8,973
|
|
|
90,706
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||
Stockholders' equity (deficit)
(2)
|
|
399,686
|
|
|
(59,463
|
)
|
|
(57,527
|
)
|
|
(4,525
|
)
|
|
38,859
|
|
(1)
|
Interest expense represents interest on liability related to sale of future royalties of $19.8 million for 2018, the Convertible Senior Notes interest expense ($3.5 million, $4.8 million and $4.8 million for 2018, 2017 and 2016, respectively) and amortized debt issuance costs (
$1.7 million
, $0.7 million and $0.7 million for 2018, 2017 and 2016, respectively).
|
(2)
|
We have never paid cash dividends on our common stock. Stockholders’ equity (deficit) represents Immunomedics, Inc. stockholders equity and the non-controlling interest in subsidiary.
|
•
|
we may be unable to obtain additional capital through strategic collaborations, licensing, issuance of convertible debt securities or equity financing in order to continue our research and secure regulatory approval of and market our drug;
|
•
|
the type of therapeutic compound under investigation and nature of the disease in connection with which the compound is being studied;
|
•
|
our ability, as well as the ability of our partners, to conduct and complete clinical trials on a timely basis;
|
•
|
the time required for us to comply with all applicable federal, state and foreign legal requirements, including, without limitation, our receipt of the necessary approvals of the FDA, if at all;
|
•
|
the financial resources available to us during any particular period; and
|
•
|
many other factors associated with the commercial development of therapeutic products outside of our control.
|
|
|
|
|
|
|
|
($ in thousands)
|
||||||||||||||||||
|
|
|
|
|
|
|
(Decrease)/Increase
|
||||||||||||||||||
Years Ended June 30,
|
2018
|
|
2017
|
|
2016
|
|
2018 vs 2017
|
|
2017 vs 2016
|
||||||||||||||||
Product sales
|
$
|
1,501
|
|
|
$
|
2,443
|
|
|
$
|
2,261
|
|
|
$
|
(942
|
)
|
|
(38.6
|
)%
|
|
$
|
182
|
|
|
8.0
|
%
|
License fee and other revenues
|
330
|
|
|
284
|
|
|
387
|
|
|
46
|
|
|
16.2
|
%
|
|
(103
|
)
|
|
(26.6
|
)%
|
|||||
Research and development
|
325
|
|
|
364
|
|
|
585
|
|
|
(39
|
)
|
|
(10.7
|
)%
|
|
(221
|
)
|
|
(37.8
|
)%
|
|||||
Total revenues
|
$
|
2,156
|
|
|
$
|
3,091
|
|
|
$
|
3,233
|
|
|
$
|
(935
|
)
|
|
(30.2
|
)%
|
|
$
|
(142
|
)
|
|
(4.4
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
($ in thousands)
|
||||||||||||||||||
|
|
|
|
|
|
|
(Decrease)/Increase
|
||||||||||||||||||
Years Ended June 30,
|
2018
|
|
2017
|
|
2016
|
|
2018 vs 2017
|
|
2017 vs 2016
|
||||||||||||||||
Costs of goods sold
|
$
|
613
|
|
|
$
|
483
|
|
|
$
|
1,159
|
|
|
$
|
130
|
|
|
26.9
|
%
|
|
$
|
(676
|
)
|
|
(58.3
|
)%
|
Research and development
|
99,283
|
|
|
51,776
|
|
|
53,492
|
|
|
47,507
|
|
|
91.8
|
%
|
|
(1,716
|
)
|
|
(3.2
|
)%
|
|||||
Sales and marketing
|
6,822
|
|
|
873
|
|
|
1,027
|
|
|
5,949
|
|
|
nm
|
|
|
(154
|
)
|
|
(15.0
|
)%
|
|||||
General and administrative
|
36,485
|
|
|
29,109
|
|
|
6,563
|
|
|
7,376
|
|
|
25.3
|
%
|
|
22,546
|
|
|
nm
|
|
|||||
Total costs and expenses
|
$
|
143,203
|
|
|
$
|
82,241
|
|
|
$
|
62,241
|
|
|
$
|
60,962
|
|
|
74.1
|
%
|
|
$
|
20,000
|
|
|
32.1
|
%
|
nm - not meaningful
|
|
|
|
|
|
|
|
|
|
|
|
|
|
•
|
the length of time required to recruit qualified patients for clinical trials;
|
•
|
the duration of patient follow-up in light of trial results;
|
•
|
the number of clinical sites required for trials; and
|
•
|
the number of patients that ultimately participate.
|
|
|
|
|
|
|
|
($ in thousands)
|
||||||||||||||||||
|
|
|
|
|
|
|
(Decrease)/Increase
|
||||||||||||||||||
Years Ended June 30,
|
2018
|
|
2017
|
|
2016
|
|
2018 vs 2017
|
|
2017 vs 2016
|
||||||||||||||||
Labor costs
|
$
|
15,648
|
|
|
$
|
8,665
|
|
|
$
|
3,883
|
|
|
$
|
6,983
|
|
|
80.6
|
%
|
|
$
|
4,782
|
|
|
nm
|
|
Legal and advisory fees
|
13,204
|
|
|
17,594
|
|
|
1,045
|
|
|
(4,390
|
)
|
|
(25.0
|
)%
|
|
16,549
|
|
|
nm
|
|
|||||
Consulting services
|
2,635
|
|
|
1,029
|
|
|
68
|
|
|
1,606
|
|
|
nm
|
|
|
961
|
|
|
nm
|
|
|||||
Other
|
4,998
|
|
|
1,821
|
|
|
1,567
|
|
|
3,177
|
|
|
nm
|
|
|
254
|
|
|
16.2
|
%
|
|||||
Total General and administrative
|
$
|
36,485
|
|
|
$
|
29,109
|
|
|
$
|
6,563
|
|
|
$
|
7,376
|
|
|
25.3
|
%
|
|
$
|
22,546
|
|
|
nm
|
|
nm- not meaningful
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
($ in thousands)
|
||||||||||
|
|
Years Ended June 30,
|
||||||||||
|
|
2018
|
|
2017
|
|
2016
|
||||||
Net cash used in operating activities
|
|
$
|
(133,951
|
)
|
|
$
|
(62,250
|
)
|
|
$
|
(48,462
|
)
|
Net cash provided by (used in) investing activities
|
|
74,757
|
|
|
(76,264
|
)
|
|
45,875
|
|
|||
Net cash provided by financing activities
|
|
627,903
|
|
|
168,803
|
|
|
2,364
|
|
|
|
Payments Due by Period
|
||||||||||||||||||||||||||
|
|
(in thousands)
|
||||||||||||||||||||||||||
Contractual Obligations
|
|
2019
|
|
2020
|
|
2021
|
|
2022
|
|
2023
|
|
Thereafter
|
|
Total
|
||||||||||||||
Convertible Senior Notes
|
|
$
|
—
|
|
|
$
|
20,000
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
20,000
|
|
Interest on long-term debt
|
|
950
|
|
|
594
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,544
|
|
|||||||
Total long-term debt
|
|
950
|
|
|
20,594
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
21,544
|
|
|||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
Purchase Obligations
(1)
|
|
10,718
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
10,718
|
|
|||||||
Operating Lease
(2)
|
|
2,447
|
|
|
1,477
|
|
|
1,523
|
|
|
1,547
|
|
|
1,575
|
|
|
12,062
|
|
|
20,631
|
|
|||||||
TOTAL
|
|
$
|
14,115
|
|
|
$
|
22,071
|
|
|
$
|
1,523
|
|
|
$
|
1,547
|
|
|
$
|
1,575
|
|
|
$
|
12,062
|
|
|
$
|
52,893
|
|
(1)
|
Purchase Obligations are primarily commitments to purchase consulting services and manufacturing.
|
(2)
|
Operating leases primarily relate to the 300 The American Road, Morris Plains, NJ 07950 building, the 400 The American Road, Morris Plains, NJ 07950 building and vehicles.
|
|
June 30,
|
||||||
|
2018
|
|
2017
|
||||
ASSETS
|
|
|
|
||||
Current Assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
612,056,502
|
|
|
$
|
43,393,570
|
|
Marketable securities
|
26,745,252
|
|
|
111,508,225
|
|
||
Accounts receivable, net of allowances of $0 and $9,371 at June 30, 2018, and 2017, respectively
|
45,773
|
|
|
488,723
|
|
||
Inventory
|
—
|
|
|
580,016
|
|
||
Prepaid expenses
|
3,802,583
|
|
|
891,284
|
|
||
Other current assets
|
5,729,710
|
|
|
436,344
|
|
||
Total current assets
|
648,379,820
|
|
|
157,298,162
|
|
||
Property and equipment, net of accumulated depreciation of $30,858,228 and $29,560,955 at June 30, 2018 and 2017, respectively
|
15,733,429
|
|
|
5,245,230
|
|
||
Other long-term assets
|
60,000
|
|
|
30,000
|
|
||
Total Assets
|
$
|
664,173,249
|
|
|
$
|
162,573,392
|
|
|
|
|
|
||||
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)
|
|
|
|
||||
Current Liabilities:
|
|
|
|
||||
Accounts payable and accrued expenses
|
$
|
31,663,648
|
|
|
$
|
31,366,976
|
|
Liability related to sale of future royalties - current
|
3,009,000
|
|
|
—
|
|
||
Warrant liabilities
|
8,973,214
|
|
|
90,706,206
|
|
||
Deferred revenues
|
93,669
|
|
|
170,967
|
|
||
Total current liabilities
|
43,739,531
|
|
|
122,244,149
|
|
||
Convertible senior notes, net
|
19,762,808
|
|
|
98,084,219
|
|
||
Liability related to sale of future royalties - non-current
|
198,997,995
|
|
|
—
|
|
||
Other long-term liabilities
|
1,987,249
|
|
|
1,708,272
|
|
||
Total Liabilities
|
264,487,583
|
|
|
222,036,640
|
|
||
Commitments and Contingencies (Note 15)
|
—
|
|
|
—
|
|
||
Stockholders' Equity (Deficit):
|
—
|
|
|
—
|
|
||
Convertible preferred stock, $0.1 par value; authorized 10,000,000 shares; no shares issued and outstanding at June 30, 2018 and 1,000,000 shares issued and outstanding at June 30, 2017
|
—
|
|
|
10,000
|
|
||
Common stock, $0.1 par value; authorized 250,000,000 shares issued 186,801,159 shares and outstanding 186,766,434 shares at June 30, 2018; shares issued 110,344,643 shares and outstanding 110,309,918 shares at June 30, 2017
|
1,868,011
|
|
|
1,103,446
|
|
||
Capital contributed in excess of par
|
1,194,997,773
|
|
|
462,666,366
|
|
||
Treasury stock, at cost: 34,725 shares at June 30, 2018 and 2017
|
(458,370
|
)
|
|
(458,370
|
)
|
||
Accumulated deficit
|
(795,547,786
|
)
|
|
(521,710,899
|
)
|
||
Accumulated other comprehensive loss
|
(352,798
|
)
|
|
(302,710
|
)
|
||
Total Immunomedics, Inc. stockholders' equity (deficit)
|
400,506,830
|
|
|
(58,692,167
|
)
|
||
Noncontrolling interest in subsidiary
|
(821,164
|
)
|
|
(771,081
|
)
|
||
Total stockholder's equity (deficit)
|
399,685,666
|
|
|
(59,463,248
|
)
|
||
Total Liabilities and Stockholders' Equity
|
$
|
664,173,249
|
|
|
$
|
162,573,392
|
|
|
Year Ended June 30,
|
||||||||||
|
2018
|
|
2017
|
|
2016
|
||||||
Revenues:
|
|
|
|
|
|
|
|
|
|||
Product sales
|
$
|
1,500,625
|
|
|
$
|
2,443,388
|
|
|
$
|
2,260,994
|
|
License fee and other revenues
|
329,956
|
|
|
284,290
|
|
|
386,941
|
|
|||
Research and development
|
325,415
|
|
|
363,572
|
|
|
585,312
|
|
|||
Total revenues
|
2,155,996
|
|
|
3,091,250
|
|
|
3,233,247
|
|
|||
|
|
|
|
|
|
||||||
Costs and Expenses:
|
|
|
|
|
|
||||||
Costs of goods sold
|
613,591
|
|
|
482,657
|
|
|
1,159,173
|
|
|||
Research and development
|
99,282,874
|
|
|
51,776,395
|
|
|
53,492,471
|
|
|||
Sales and marketing
|
6,822,174
|
|
|
873,154
|
|
|
1,027,139
|
|
|||
General and administrative
|
36,484,641
|
|
|
29,108,777
|
|
|
6,562,555
|
|
|||
Total costs and expenses
|
143,203,280
|
|
|
82,240,983
|
|
|
62,241,338
|
|
|||
Operating loss
|
141,047,284
|
|
|
(79,149,733
|
)
|
|
(59,008,091
|
)
|
|||
Changes in fair market value of warrant liabilities
|
(108,635,809
|
)
|
|
(61,073,808
|
)
|
|
—
|
|
|||
Warrant related expenses
|
—
|
|
|
(7,649,395
|
)
|
|
—
|
|
|||
Interest expense
|
(23,254,787
|
)
|
|
(5,479,821
|
)
|
|
(5,479,821
|
)
|
|||
Interest and other income
|
5,492,632
|
|
|
430,595
|
|
|
337,901
|
|
|||
Other financing expenses
|
(13,005,329
|
)
|
|
(346,568
|
)
|
|
—
|
|
|||
Insurance reimbursement
|
6,637,992
|
|
|
—
|
|
|
—
|
|
|||
Foreign currency transaction gain (loss), net
|
81,423
|
|
|
23,311
|
|
|
(39,538
|
)
|
|||
Loss before income tax
|
(273,731,162
|
)
|
|
(153,245,419
|
)
|
|
(64,189,549
|
)
|
|||
Income tax (expense) benefit
|
(155,808
|
)
|
|
(20,867
|
)
|
|
5,053,833
|
|
|||
Net loss
|
(273,886,970
|
)
|
|
(153,266,286
|
)
|
|
(59,135,716
|
)
|
|||
Net loss attributable to noncontrolling interest
|
(50,083
|
)
|
|
(60,341
|
)
|
|
(98,766
|
)
|
|||
Net loss attributable to Immunomedics, Inc. stockholders
|
$
|
(273,836,887
|
)
|
|
$
|
(153,205,945
|
)
|
|
$
|
(59,036,950
|
)
|
Loss per common share attributable to Immunomedics, Inc. stockholders (basic and diluted):
|
$
|
(1.78
|
)
|
|
$
|
(1.47
|
)
|
|
$
|
(0.62
|
)
|
Weighted average shares used to calculated loss per common share (basic and diluted)
|
153,474,943
|
|
|
104,535,577
|
|
|
94,770,172
|
|
|||
Other comprehensive (loss) income, net of tax:
|
|
|
|
|
|
||||||
Foreign currency translation adjustments
|
(105,285
|
)
|
|
(62,085
|
)
|
|
1,192
|
|
|||
Unrealized gain (loss) on securities available for sale
|
55,197
|
|
|
(108,399
|
)
|
|
27,674
|
|
|||
Other comprehensive income (loss), net of tax:
|
(50,088
|
)
|
|
(170,484
|
)
|
|
28,866
|
|
|||
Comprehensive loss
|
(273,937,058
|
)
|
|
(153,436,770
|
)
|
|
(59,106,850
|
)
|
|||
Comprehensive loss attributable to noncontrolling interest
|
(50,083
|
)
|
|
(60,341
|
)
|
|
(98,766
|
)
|
|||
Comprehensive loss attributable to Immunomedics, Inc. stockholders
|
$
|
(273,886,975
|
)
|
|
$
|
(153,376,429
|
)
|
|
$
|
(59,008,084
|
)
|
|
Immunomedics, Inc. Stockholders
|
|
|
|
|
||||||||||||||||||||||||||||||||
|
Convertible Preferred Stock
|
|
|
|
|
|
Capital Contributed in Excess of Par
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss)
|
|
|
|
|
||||||||||||||||||||
|
|
Common Stock
|
|
|
Treasury Stock
|
|
Accumulated Deficit
|
|
|
Noncontrolling Interest
|
|
|
|||||||||||||||||||||||||
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
|
|
|
|
|
Total
|
|||||||||||||||||||||||
Balance at June 30, 2015
|
—
|
|
|
$
|
—
|
|
|
94,546,578
|
|
|
$
|
945,465
|
|
|
$
|
305,229,354
|
|
|
$
|
(458,370
|
)
|
|
$
|
(309,468,004
|
)
|
|
$
|
(161,092
|
)
|
|
$
|
(611,974
|
)
|
|
$
|
(4,524,621
|
)
|
Exercise of stock options, net
|
|
|
|
|
1,097,500
|
|
|
10,975
|
|
|
2,721,987
|
|
|
|
|
|
|
|
|
|
|
2,732,962
|
|
||||||||||||||
Stock based compensation
|
|
|
|
|
223,220
|
|
|
2,232
|
|
|
3,369,310
|
|
|
|
|
|
|
|
|
|
|
3,371,542
|
|
||||||||||||||
Other comprehensive income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
28,866
|
|
|
|
|
28,866
|
|
||||||||||||||||
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
(59,036,950
|
)
|
|
|
|
(98,766
|
)
|
|
(59,135,716
|
)
|
|||||||||||||||
Balance at June 30, 2016
|
—
|
|
|
$
|
—
|
|
|
95,867,298
|
|
|
$
|
958,672
|
|
|
$
|
311,320,651
|
|
|
$
|
(458,370
|
)
|
|
$
|
(368,504,954
|
)
|
|
$
|
(132,226
|
)
|
|
$
|
(710,740
|
)
|
|
$
|
(57,526,967
|
)
|
Issuance of preferred stock, net
|
1,000,000
|
|
|
10,000
|
|
|
|
|
|
|
121,771,941
|
|
|
|
|
|
|
|
|
|
|
121,781,941
|
|
||||||||||||||
Issuance of common stock in public offering, net
|
|
|
|
|
10,000,000
|
|
|
100,000
|
|
|
28,478,473
|
|
|
|
|
|
|
|
|
|
|
28,578,473
|
|
||||||||||||||
Proceeds of public offering allocated to warrant liability
|
|
|
|
|
|
|
|
|
(6,966,435
|
)
|
|
|
|
|
|
|
|
|
|
(6,966,435
|
)
|
||||||||||||||||
Issuance of common stock to Seattle Genetics, Inc.
|
|
|
|
|
3,000,000
|
|
|
30,000
|
|
|
14,670,000
|
|
|
|
|
|
|
|
|
|
|
14,700,000
|
|
||||||||||||||
Proceeds of share issuance to Seattle Genetics, Inc. allocated to warrant liability
|
|
|
|
|
|
|
|
|
(14,670,000
|
)
|
|
|
|
|
|
|
|
|
|
(14,670,000
|
)
|
||||||||||||||||
Exercise of stock options, net
|
|
|
|
|
1,279,354
|
|
|
12,794
|
|
|
4,277,309
|
|
|
|
|
|
|
|
|
|
|
4,290,103
|
|
||||||||||||||
Stock based compensation
|
|
|
|
|
197,991
|
|
|
1,980
|
|
|
3,784,427
|
|
|
|
|
|
|
|
|
|
|
3,786,407
|
|
||||||||||||||
Other comprehensive (loss)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(170,484
|
)
|
|
|
|
(170,484
|
)
|
||||||||||||||||
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
(153,205,945
|
)
|
|
|
|
(60,341
|
)
|
|
(153,266,286
|
)
|
|||||||||||||||
Balance at June 30, 2017
|
1,000,000
|
|
|
$
|
10,000
|
|
|
110,344,643
|
|
|
$
|
1,103,446
|
|
|
$
|
462,666,366
|
|
|
$
|
(458,370
|
)
|
|
$
|
(521,710,899
|
)
|
|
$
|
(302,710
|
)
|
|
$
|
(771,081
|
)
|
|
$
|
(59,463,248
|
)
|
Reclassification of warrant liability to equity
|
|
|
|
|
—
|
|
|
—
|
|
|
190,368,801
|
|
|
|
|
|
|
|
|
|
|
190,368,801
|
|
||||||||||||||
Exercise of common stock warrants
|
|
|
|
|
18,205,804
|
|
|
182,058
|
|
|
78,043,882
|
|
|
|
|
|
|
|
|
|
|
78,225,940
|
|
||||||||||||||
Exercise of stock options, net
|
|
|
|
|
585,915
|
|
|
5,859
|
|
|
2,255,381
|
|
|
|
|
|
|
|
|
|
|
2,261,240
|
|
||||||||||||||
Issuance of common stock to RPI Finance Trust
|
|
|
|
|
4,373,178
|
|
|
43,732
|
|
|
67,740,268
|
|
|
|
|
|
|
|
|
|
|
67,784,000
|
|
||||||||||||||
Issuance of common stock in public offering, net
|
|
|
|
|
13,225,000
|
|
|
132,250
|
|
|
299,334,650
|
|
|
|
|
|
|
|
|
|
|
299,466,900
|
|
||||||||||||||
Conversion of Preferred Shares
|
(1,000,000
|
)
|
|
(10,000
|
)
|
|
23,105,360
|
|
|
231,054
|
|
|
(221,054
|
)
|
|
|
|
|
|
|
|
|
|
—
|
|
||||||||||||
Issuance of common stock due to debt conversion
|
|
|
|
|
16,799,861
|
|
|
167,999
|
|
|
92,307,266
|
|
|
|
|
|
|
|
|
|
|
92,475,265
|
|
||||||||||||||
Stock based compensation
|
|
|
|
|
331,329
|
|
|
3,312
|
|
|
4,023,697
|
|
|
|
|
|
|
|
|
|
|
4,027,009
|
|
||||||||||||||
Conversion of RSU's for tax withholding payments
|
|
|
|
|
(169,931
|
)
|
|
(1,699
|
)
|
|
(1,521,484
|
)
|
|
|
|
|
|
|
|
|
|
|
(1,523,183
|
)
|
|||||||||||||
Other comprehensive income (loss)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(50,088
|
)
|
|
|
|
(50,088
|
)
|
||||||||||||||||
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
(273,836,887
|
)
|
|
|
|
(50,083
|
)
|
|
(273,886,970
|
)
|
|||||||||||||||
Balance at June 30, 2018
|
—
|
|
|
$
|
—
|
|
|
186,801,159
|
|
|
$
|
1,868,011
|
|
|
$
|
1,194,997,773
|
|
|
$
|
(458,370
|
)
|
|
$
|
(795,547,786
|
)
|
|
$
|
(352,798
|
)
|
|
$
|
(821,164
|
)
|
|
$
|
399,685,666
|
|
|
Years ended June 30,
|
||||||||||
|
2018
|
|
2017
|
|
2016
|
||||||
Cash flows from operating activities:
|
|
|
|
|
|
|
|
|
|||
Net loss
|
$
|
(273,886,970
|
)
|
|
$
|
(153,266,286
|
)
|
|
$
|
(59,135,716
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
||||||
Changes in fair value of warrant liabilities
|
108,635,809
|
|
|
61,073,808
|
|
|
—
|
|
|||
Warrant related expense
|
—
|
|
|
7,649,395
|
|
|
—
|
|
|||
Depreciation and amortization
|
1,297,273
|
|
|
923,348
|
|
|
737,661
|
|
|||
Interest on non-recourse debt
|
19,789,995
|
|
|
—
|
|
|
—
|
|
|||
Loss on induced exchanges of debt
|
13,005,329
|
|
|
—
|
|
|
—
|
|
|||
Deferred revenue, net of amortization
|
(77,298
|
)
|
|
(64,405
|
)
|
|
(36,295
|
)
|
|||
Amortization of bond premiums
|
30,795
|
|
|
218,426
|
|
|
669,858
|
|
|||
Amortization of debt issuance costs
|
1,678,589
|
|
|
729,821
|
|
|
729,821
|
|
|||
Amortization of deferred rent
|
278,977
|
|
|
8,996
|
|
|
99,516
|
|
|||
Loss (gain) on sale of marketable securities
|
434
|
|
|
15,682
|
|
|
(1,844
|
)
|
|||
(Decrease) increase in allowance for doubtful accounts
|
(9,371
|
)
|
|
(61,932
|
)
|
|
20,369
|
|
|||
Non-cash expense related to stock compensation
|
4,023,697
|
|
|
4,333,430
|
|
|
3,740,526
|
|
|||
Non-cash decrease in value of life insurance policy
|
—
|
|
|
—
|
|
|
20,566
|
|
|||
Non-cash financing expenses
|
—
|
|
|
346,568
|
|
|
—
|
|
|||
Changes in operating assets and liabilities
|
|
|
|
|
|
||||||
Accounts receivable - net of reserve
|
452,321
|
|
|
102,640
|
|
|
(190,300
|
)
|
|||
Inventories - net of reserve
|
580,016
|
|
|
(195,958
|
)
|
|
256,381
|
|
|||
Other receivables
|
(30,000
|
)
|
|
223,340
|
|
|
620,300
|
|
|||
Prepaid expenses
|
(2,911,299
|
)
|
|
146,871
|
|
|
97,948
|
|
|||
Other current assets
|
(5,293,365
|
)
|
|
(241,775
|
)
|
|
761,803
|
|
|||
Accounts payable and accrued expenses
|
(1,515,818
|
)
|
|
15,807,887
|
|
|
3,147,606
|
|
|||
Net cash used in operating activities
|
(133,950,886
|
)
|
|
(62,250,144
|
)
|
|
(48,461,800
|
)
|
|||
Cash flows from investing activities
|
|
|
|
|
|
||||||
Purchases of marketable securities
|
(10,380,182
|
)
|
|
(131,610,011
|
)
|
|
(2,749,117
|
)
|
|||
Purchases from sales/maturities of marketable securities
|
95,111,926
|
|
|
57,183,499
|
|
|
50,850,088
|
|
|||
Purchases of property and equipment
|
(9,974,683
|
)
|
|
(1,837,167
|
)
|
|
(2,226,256
|
)
|
|||
Net cash provided by (used in) investing activities
|
74,757,061
|
|
|
(76,263,679
|
)
|
|
45,874,715
|
|
|||
Cash flows from financing activities:
|
|
|
|
|
|
||||||
Exercise of stock options
|
2,261,240
|
|
|
4,290,103
|
|
|
2,732,962
|
|
|||
Exercise of warrants
|
78,225,940
|
|
|
—
|
|
|
—
|
|
|||
Sale of preferred stock, net of related expenses
|
—
|
|
|
121,781,941
|
|
|
—
|
|
|||
Proceeds from public offering of common stock
|
299,466,900
|
|
|
28,578,473
|
|
|
—
|
|
|||
Proceeds from private offering of common stock
|
67,784,000
|
|
|
14,700,000
|
|
|
—
|
|
|||
Proceeds from the issuance of non-recourse debt
|
182,216,000
|
|
|
—
|
|
|
—
|
|
|||
Debt conversion fees
|
(530,064
|
)
|
|
—
|
|
|
—
|
|
|||
Tax withholding payments for stock compensation
|
(1,521,484
|
)
|
|
(547,021
|
)
|
|
(368,984
|
)
|
|||
Net cash provided by financing activities
|
627,902,532
|
|
|
168,803,496
|
|
|
2,363,978
|
|
|||
Effect of changes in exchange rates on cash and cash equivalents
|
(45,775
|
)
|
|
(99,728
|
)
|
|
(26,043
|
)
|
|||
Net increase (decrease) in cash and cash equivalents
|
568,662,932
|
|
|
30,189,945
|
|
|
(249,150
|
)
|
|||
Cash and cash equivalents beginning of period
|
43,393,570
|
|
|
13,203,625
|
|
|
13,452,775
|
|
|||
Cash and cash equivalents end of period
|
$
|
612,056,502
|
|
|
$
|
43,393,570
|
|
|
$
|
13,203,625
|
|
Supplemental disclosure of cash flow information:
|
|
|
|
|
|
||||||
Interest paid
|
$
|
2,850,000
|
|
|
$
|
4,750,000
|
|
|
$
|
4,802,778
|
|
Income taxes paid
|
$
|
—
|
|
|
$
|
23,636
|
|
|
$
|
28,679
|
|
Schedule for non-cash investing and financing activities:
|
|
|
|
|
|
||||||
Issuance of Common Shares for Debt Conversion
|
$
|
92,307,266
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Accrued capital expenditures
|
$
|
2,173,038
|
|
|
$
|
—
|
|
|
$
|
—
|
|
•
|
Level 1 -
Financial instruments whose values are based on unadjusted quoted prices for identical assets or liabilities in an active market which the company has the ability to access at the measurement date (examples include active exchange-traded securities and most United States Government and agency securities).
|
•
|
Level 2 -
Financial instruments whose value are based on quoted market prices in markets where trading occurs infrequently or whose values are based on quoted prices of instruments with similar attributes in active markets.
|
•
|
Level 3 -
Financial instruments whose values are based on prices or valuation techniques that require inputs that are both unobservable and significant to the overall fair value measurement. These inputs reflect management's own assumptions about the assumptions a market participant would use in pricing the asset.
|
|
|
|
Gross
|
|
Gross
|
|
|
||||||||
|
Amortized
|
|
Unrealized
|
|
Unrealized
|
|
|
||||||||
|
Cost
|
|
Gain
|
|
(Loss)
|
|
Fair Value
|
||||||||
U.S. Treasury Bonds
|
$
|
9,641
|
|
|
$
|
—
|
|
|
$
|
(9
|
)
|
|
$
|
9,632
|
|
Certificate of Deposits
|
5,610
|
|
|
—
|
|
|
—
|
|
|
5,610
|
|
||||
U.S. Government Sponsored Agencies
|
6,751
|
|
|
—
|
|
|
(2
|
)
|
|
6,749
|
|
||||
Corporate Debt Securities
|
4,510
|
|
|
—
|
|
|
(5
|
)
|
|
4,505
|
|
||||
Commercial Paper
|
249
|
|
|
—
|
|
|
—
|
|
|
249
|
|
||||
|
$
|
26,761
|
|
|
$
|
—
|
|
|
$
|
(16
|
)
|
|
$
|
26,745
|
|
|
|
|
Net
|
||||
|
|
|
Carrying
|
||||
|
Fair Value
|
|
Amount
|
||||
Due within one year
|
$
|
21,745
|
|
|
$
|
21,860
|
|
Due after one year through five years
|
5,000
|
|
|
5,009
|
|
||
|
$
|
26,745
|
|
|
$
|
26,869
|
|
|
|
|
Gross
|
|
Gross
|
|
|
||||||||
|
Amortized
|
|
Unrealized
|
|
Unrealized
|
|
|
||||||||
|
Cost
|
|
Gain
|
|
(Loss)
|
|
Fair Value
|
||||||||
U.S. Treasury Bonds
|
$
|
35,086
|
|
|
$
|
—
|
|
|
$
|
(24
|
)
|
|
$
|
35,062
|
|
Certificate of Deposits
|
15,298
|
|
|
—
|
|
|
—
|
|
|
15,298
|
|
||||
U.S. Government Sponsored Agencies
|
18,357
|
|
|
—
|
|
|
(13
|
)
|
|
18,344
|
|
||||
Corporate Debt Securities
|
32,692
|
|
|
—
|
|
|
(33
|
)
|
|
32,659
|
|
||||
Commercial Paper
|
10,144
|
|
|
1
|
|
|
—
|
|
|
10,145
|
|
||||
|
$
|
111,577
|
|
|
$
|
1
|
|
|
$
|
(70
|
)
|
|
$
|
111,508
|
|
|
|
Allocated
|
||
Units of Accounting:
|
Consideration
|
|||
|
Liability related to sale of future royalties
|
$
|
182,216
|
|
|
Common stock
|
67,784
|
|
|
|
|
$
|
250,000
|
|
Liability related to sale of future royalties at January 7, 2018
|
$
|
182,216
|
|
Interest expense recognized
|
19,791
|
|
|
Carrying value of liability related to sale of future royalties at June 30, 2018
|
$
|
202,007
|
|
|
Fiscal Year Ended June 30,
|
||||||||||
|
2018
|
|
2017
|
|
2016
|
||||||
Research and development
|
$
|
2,414
|
|
|
$
|
2,600
|
|
|
$
|
2,245
|
|
General and administrative
|
1,610
|
|
|
1,733
|
|
|
1,496
|
|
|||
Total share-based compensation expense
|
$
|
4,024
|
|
|
$
|
4,333
|
|
|
$
|
3,741
|
|
|
Years Ended June 30,
|
||||
|
2018
|
|
2017
|
|
2016
|
Expected dividend yield
|
—%
|
|
—%
|
|
—%
|
Expected option term (years)
|
4.84
|
|
5.04
|
|
5.03
|
Expected stock price volatility
|
70%
|
|
63%
|
|
58%
|
Risk-free interest rate
|
1.72% - 2.89%
|
|
1.16% - 2.15%
|
|
1.00% - 1.64%
|
|
|
|
|
|
Weighted
|
|
|
|||||
|
|
|
Weighted
|
|
Average Remaining
|
|
Aggregate
|
|||||
|
Options
|
|
Average Exercise
|
|
Contractual
|
|
Intrinsic Value
|
|||||
|
(in thousands)
|
|
Price Per Option
|
|
Term (Years)
|
|
(in thousands)
|
|||||
Options outstanding, beginning of year
|
2,893
|
|
|
$
|
3.48
|
|
|
3.96
|
|
$
|
15,490
|
|
Changes during the year:
|
|
|
|
|
|
|
|
|||||
Granted
|
1,370
|
|
|
$
|
14.90
|
|
|
|
|
|
||
Exercised
|
(586
|
)
|
|
$
|
3.86
|
|
|
|
|
|
||
Expired or forfeited
|
(128
|
)
|
|
$
|
10.19
|
|
|
|
|
|
||
Options outstanding, end of year
|
3,549
|
|
|
$
|
7.58
|
|
|
4.43
|
|
$
|
57,123
|
|
Vested as of June 30, 2018
|
1,852
|
|
|
$
|
3.47
|
|
|
2.90
|
|
$
|
37,420
|
|
Non-Vested Restricted Stock Units
|
|
Share Equivalent (in thousands)
|
|
Weighted Average Grant Date Fair Value
|
|||
Non-vested at June 30, 2017
|
|
1,500
|
|
|
$
|
2.28
|
|
Changes during the period:
|
|
|
|
|
|||
Restricted Units Granted
|
|
35
|
|
|
8.46
|
|
|
Vested/Exercised
|
|
—
|
|
|
—
|
|
|
Non-vested at June 30, 2018
|
|
1,535
|
|
|
$
|
2.83
|
|
Non-Vested Performance Stock Units
|
|
Share Equivalent (in thousands)
|
|
Weighted Average Grant Date Fair Value
|
|||
Non-vested at June 30, 2017
|
|
—
|
|
|
$
|
—
|
|
Changes during the period:
|
|
|
|
|
|||
Performance Units Granted
|
|
538
|
|
|
7.29
|
|
|
Canceled
|
|
—
|
|
|
—
|
|
|
Vested/Exercised
|
|
—
|
|
|
—
|
|
|
Non-vested at June 30, 2018
|
|
538
|
|
|
$
|
7.29
|
|
|
($ in thousands)
|
||||||||||||||
June 30, 2017
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
||||||||
Money Market Funds Note (a)
|
$
|
36,776
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
36,776
|
|
Marketable Securities:
|
|
|
|
|
|
|
|
||||||||
U.S. Treasury Bonds
|
35,062
|
|
|
—
|
|
|
—
|
|
|
35,062
|
|
||||
Certificate of Deposits
|
15,298
|
|
|
—
|
|
|
—
|
|
|
15,298
|
|
||||
U.S. Government Sponsored Agencies
|
18,344
|
|
|
—
|
|
|
—
|
|
|
18,344
|
|
||||
Corporate Debt Securities
|
32,659
|
|
|
—
|
|
|
—
|
|
|
32,659
|
|
||||
Commercial Paper
|
10,145
|
|
|
—
|
|
|
—
|
|
|
10,145
|
|
||||
Total
|
$
|
148,284
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
148,284
|
|
|
As of June 30, 2018
|
|
As of June 30, 2017
|
||||||||||||
|
Carrying
|
|
Estimated
|
|
Carrying
|
|
Estimated
|
||||||||
|
Amount
|
|
Fair Value
|
|
Amount
|
|
Fair Value
|
||||||||
Convertible Senior Notes
|
$
|
19,763
|
|
|
$
|
89,436
|
|
|
$
|
98,084
|
|
|
$
|
180,950
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2018
(2)
|
|
June 30, 2017
(1)
|
|
June 30, 2017
(2)
|
|
February 10, 2017
|
|
October 11, 2016
|
Risk-free interest rate
|
1.95%
|
|
1.14%
|
|
1.38%
|
|
1.47%
|
|
0.87%
|
Expected remaining term
|
0.28 years
|
|
0.5 years
|
|
1.3 years
|
|
3.0 years
|
|
2.0 years
|
Expected volatility
|
60.00%
|
|
69.34%
|
|
73.85%
|
|
71.42%
|
|
75.00%
|
Dividend yield
|
—%
|
|
—%
|
|
—%
|
|
—%
|
|
—%
|
(1)
|
Represents the fair value assumptions for the warrants issued in connection with February 10, 2017 stock purchase agreement.
|
(2)
|
Represents the fair value assumptions for the warrants issued in connection with October 11, 2016 public offering.
|
|
Number of
|
|
Estimated Fair Value
|
|||
(in thousands)
|
Warrants
|
|
Level 2
|
|||
Fair value - 6/30/2017
|
18,656
|
|
|
$
|
90,706
|
|
Reclassification of warrant liability to equity
|
(18,206
|
)
|
|
(190,369
|
)
|
|
Changes in fair market value of warrant liabilities
|
—
|
|
|
108,636
|
|
|
Fair value - 6/30/2018
|
450
|
|
|
$
|
8,973
|
|
|
Lives
|
|
|
|
|
||||
|
(Years)
|
|
2018
|
|
2017
|
||||
Machinery and equipment
|
5-10
|
|
$
|
11,216
|
|
|
$
|
9,353
|
|
Leasehold improvements
|
7-10
|
|
30,657
|
|
|
21,602
|
|
||
Furniture and fixtures
|
10
|
|
1,070
|
|
|
976
|
|
||
Computer equipment
|
5
|
|
3,648
|
|
|
2,875
|
|
||
|
|
|
46,591
|
|
|
34,806
|
|
||
Accumulated depreciation and amortization
|
|
|
(30,858
|
)
|
|
(29,561
|
)
|
||
|
|
|
$
|
15,733
|
|
|
$
|
5,245
|
|
|
2018
|
|
2017
|
||||
Trade accounts payable
|
$
|
24,818
|
|
|
$
|
5,222
|
|
Clinical trial accruals
|
2,110
|
|
|
2,865
|
|
||
Executive severance liabilities
|
2,388
|
|
|
5,542
|
|
||
Reimbursement for proxy expenses
|
484
|
|
|
4,505
|
|
||
Contract manufacture organization expenses
|
—
|
|
|
3,769
|
|
||
Proxy defense-related expenses
|
—
|
|
|
6,967
|
|
||
Miscellaneous other current liabilities
|
1,864
|
|
|
2,497
|
|
||
|
$
|
31,664
|
|
|
$
|
31,367
|
|
|
Currency
|
|
Net Unrealized Gains
|
|
Accumulated Other
|
||||||
|
Translation
|
|
(Losses) on Available-
|
|
Comprehensive
|
||||||
|
Adjustments
|
|
for-Sale Securities
|
|
(Loss) Income
|
||||||
Balance at June 30, 2015
|
$
|
(173
|
)
|
|
$
|
12
|
|
|
$
|
(161
|
)
|
Other comprehensive income before reclassifications
|
1
|
|
|
30
|
|
|
31
|
|
|||
Amounts reclassified from accumulated other comprehensive (loss)
(a)
|
—
|
|
|
(2
|
)
|
|
(2
|
)
|
|||
Net other comprehensive income for the year
|
1
|
|
|
28
|
|
|
29
|
|
|||
Balance at June 30, 2016
|
(172
|
)
|
|
40
|
|
|
(132
|
)
|
|||
Other comprehensive loss before reclassifications
|
(62
|
)
|
|
(125
|
)
|
|
(187
|
)
|
|||
Amounts reclassified from accumulated other comprehensive income
(a)
|
—
|
|
|
16
|
|
|
16
|
|
|||
Net other comprehensive loss for the year
|
(62
|
)
|
|
(109
|
)
|
|
(171
|
)
|
|||
Balance at June 30, 2017
|
(234
|
)
|
|
(69
|
)
|
|
(303
|
)
|
|||
Other comprehensive income before reclassifications
|
(105
|
)
|
|
55
|
|
|
(50
|
)
|
|||
Amounts reclassified from accumulated other comprehensive income (loss)
(a)
|
—
|
|
|
—
|
|
|
—
|
|
|||
Net other comprehensive (loss) income for the year
|
(105
|
)
|
|
55
|
|
|
(50
|
)
|
|||
Balance at June 30, 2018
|
$
|
(339
|
)
|
|
$
|
(14
|
)
|
|
$
|
(353
|
)
|
(a)
|
For the fiscal years ended
June 30, 2018
,
2017
and
2016
,
zero
,
$16 thousand
and
$2 thousand
, respectively, were reclassified from accumulated other comprehensive (loss) income to interest and other income, respectively.
|
|
Year Ended June 30,
|
||||||||||
|
2018
|
|
2017
|
|
2016
|
||||||
Federal
|
|
|
|
|
|
||||||
Current
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Deferred
|
—
|
|
|
—
|
|
|
—
|
|
|||
Total Federal
|
—
|
|
|
—
|
|
|
—
|
|
|||
State
|
|
|
|
|
|
||||||
Current
|
2
|
|
|
2
|
|
|
(5,054
|
)
|
|||
Deferred
|
—
|
|
|
—
|
|
|
—
|
|
|||
Total State
|
2
|
|
|
2
|
|
|
(5,054
|
)
|
|||
Foreign
|
|
|
|
|
|
||||||
Current
|
154
|
|
|
19
|
|
|
—
|
|
|||
Deferred
|
—
|
|
|
—
|
|
|
—
|
|
|||
Total Foreign
|
154
|
|
|
19
|
|
|
—
|
|
|||
Total Expense (Benefit)
|
$
|
156
|
|
|
$
|
21
|
|
|
$
|
(5,054
|
)
|
|
2018
|
|
2017
|
|
2016
|
|||
Statutory rate
|
(28.0
|
)%
|
|
(34.0
|
)%
|
|
(34.0
|
)%
|
Foreign income tax
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
Change in valuation allowance
|
21.1
|
%
|
|
21.9
|
%
|
|
30.4
|
%
|
State income taxes, (net of federal tax benefit)
|
(4.3
|
)%
|
|
(4.8
|
)%
|
|
(2.8
|
)%
|
Permanent differences, (primarily warrant-related expenses)
|
11.3
|
%
|
|
15.3
|
%
|
|
—
|
%
|
Other
|
—
|
%
|
|
1.6
|
%
|
|
(1.6
|
)%
|
Effective rate
|
0.1
|
%
|
|
—
|
%
|
|
(8.0
|
)%
|
|
2018
|
|
2017
|
||||
Deferred tax assets:
|
|
|
|
|
|||
NOL carry forwards
|
$
|
90,931
|
|
|
$
|
134,476
|
|
Research and development credits
|
17,730
|
|
|
14,357
|
|
||
Property and equipment
|
—
|
|
|
3,406
|
|
||
Liability related to sale of future royalties
|
49,235
|
|
|
—
|
|
||
Other
|
3,489
|
|
|
7,335
|
|
||
Total
|
161,385
|
|
|
159,574
|
|
||
Valuation allowance
|
(160,540
|
)
|
|
(159,574
|
)
|
||
Net deferred assets
|
$
|
845
|
|
|
$
|
—
|
|
Deferred tax liabilities:
|
|
|
|
||||
Property and equipment
|
$
|
(845
|
)
|
|
$
|
—
|
|
Net deferred assets and liabilities
|
$
|
—
|
|
|
$
|
—
|
|
2019
|
$
|
2,447
|
|
2020
|
$
|
1,477
|
|
2021
|
$
|
1,523
|
|
2022
|
$
|
1,547
|
|
2023
|
$
|
1,575
|
|
Thereafter
|
$
|
12,062
|
|
|
June 30,
|
||||||
|
2018
|
|
2017
|
||||
Property and equipment, net:
|
|
|
|
|
|
||
United States
|
$
|
15,649
|
|
|
$
|
5,166
|
|
Europe
|
84
|
|
|
79
|
|
||
Total
|
$
|
15,733
|
|
|
$
|
5,245
|
|
|
June 30,
|
||||||||||
|
2018
|
|
2017
|
|
2016
|
||||||
Revenues:
|
|
|
|
|
|
|
|
|
|||
United States
|
$
|
655
|
|
|
$
|
648
|
|
|
$
|
972
|
|
Europe
|
1,501
|
|
|
2,443
|
|
|
2,261
|
|
|||
Total
|
2,156
|
|
|
3,091
|
|
|
3,233
|
|
|||
|
|
|
|
|
|
||||||
(Loss) income before taxes:
|
|
|
|
|
|
||||||
United States
|
(274,260
|
)
|
|
(153,348
|
)
|
|
(63,688
|
)
|
|||
Europe
|
529
|
|
|
103
|
|
|
(502
|
)
|
|||
Total
|
$
|
(273,731
|
)
|
|
$
|
(153,245
|
)
|
|
$
|
(64,190
|
)
|
|
Three Months Ended
|
||||||||||||||
(In thousands, except for per share amounts)
|
June 30, 2018
|
|
March 31, 2018
|
|
December 31, 2017
|
|
September 30, 2017
|
||||||||
Consolidated Statements of Comprehensive Loss Data:
|
|
|
|
|
|
|
|
||||||||
Revenues
|
$
|
387
|
|
|
$
|
482
|
|
|
$
|
597
|
|
|
$
|
690
|
|
Net loss attributable to Immunomedics, Inc. stockholders
|
$
|
(117,032
|
)
|
|
$
|
(35,546
|
)
|
|
$
|
(2,514
|
)
|
|
$
|
(118,745
|
)
|
Loss per common share attributable to Immunomedics Inc. stockholders – (basic and diluted)
|
$
|
(0.68
|
)
|
|
$
|
(0.21
|
)
|
|
$
|
(0.02
|
)
|
|
$
|
(0.97
|
)
|
Weighted average shares used to calculate loss per common share – (basic and diluted)
|
171,124
|
|
|
166,054
|
|
|
154,487
|
|
|
122,550
|
|
|
Three Months Ended
|
||||||||||||||
(In thousands, except for per share amounts)
|
June 30, 2017
|
|
March 31, 2017
|
|
December 31, 2016
|
|
September 30, 2016
|
||||||||
Consolidated Statements of Comprehensive Loss Data:
|
|
|
|
|
|
|
|
||||||||
Revenues
|
$
|
642
|
|
|
$
|
1,323
|
|
|
$
|
384
|
|
|
$
|
742
|
|
Net loss attributable to Immunomedics, Inc. stockholders
|
$
|
(53,255
|
)
|
|
$
|
(59,306
|
)
|
|
$
|
(24,447
|
)
|
|
$
|
(16,198
|
)
|
Loss per common share attributable to Immunomedics Inc. stockholders – (basic and diluted)
|
$
|
(0.48
|
)
|
|
$
|
(0.56
|
)
|
|
$
|
(0.25
|
)
|
|
$
|
(0.18
|
)
|
Weighted average shares used to calculate loss per common share – (basic and diluted)
|
109,891
|
|
|
107,840
|
|
|
104,657
|
|
|
95,884
|
|
Plan Category
|
|
Number of securities to be
issued upon vesting of
restricted shares and
exercise of outstanding
options and rights
|
|
Weighted-average exercise price of outstanding options and rights
|
|
Number of securities remaining available for future grant under equity compensation plans
|
||||
Equity compensation plans approved by security holders
(1)
|
|
5,621,438
|
|
|
$
|
7.15
|
|
|
8,643,548
|
|
Equity compensation plans not approved by security holders
|
|
—
|
|
|
—
|
|
|
—
|
|
|
Total
|
|
5,621,438
|
|
|
$
|
7.15
|
|
|
8,643,548
|
|
(1)
|
Refers to Immunomedics, Inc. 2014 Long-Term Incentive Plan.
|
|
(a)
Documents filed as part of this Report:
|
|
1.
|
|
Consolidated Financial Statements:
|
|
|
Consolidated Balance Sheets – June 30, 2018 and 2017
|
|
|
Consolidated Statements of Comprehensive Loss for the years ended June 30, 2018, 2017 and 2016
|
|
|
Consolidated Statements of Changes in Stockholders’ Equity (Deficit) for the years ended June 30, 2018, 2017 and 2016
|
|
|
Consolidated Statements of Cash Flows for the years ended June 30, 2018, 2017 and 2016
|
|
|
Notes to Consolidated Financial Statements
|
|
|
Reports of Independent Registered Public Accounting Firm – KPMG LLP
|
2.
|
|
Financial Statement Schedule:
|
|
|
none.
|
3.
|
|
List of Exhibits
|
Exhibit No.
|
|
Description
|
3.(i).1
|
|
|
3.(i).2
|
|
|
3.(iii).1
|
|
|
3.(iii).2
|
|
3.(iii).3
|
|
|
4.1
|
|
|
4.2
|
|
|
4.3
|
|
|
4.4
|
|
|
4.5
|
|
|
10.1
|
|
Amended and Restated License Agreement among the Company, David M. Goldenberg and the Center for Molecular Medicine and Immunology, Inc., dated December 11, 1990, incorporated by reference from the Exhibits to the Company’s Registration Statement on Form S-2 effective July 24, 1991 (Commission File No. 33-41053). (P)
|
10.2
|
|
|
10.3
|
|
|
10.4
|
|
|
10.5
|
|
|
10.6
|
|
Lease Agreement with Baker Properties Limited Partnership, dated January 16, 1992, incorporated by reference from the Exhibits to the Company’s Registration Statement on Form S-2 (Commission File No. 33-44750), effective January 30, 1992. (P)
|
10.7
|
|
|
10.8
|
|
|
10.9
|
|
|
10.10
|
|
|
10.11
|
|
10.12
|
|
|
10.13#
|
|
|
10.14#
|
|
|
10.15#
|
|
|
10.16#
|
|
|
10.17#
|
|
|
10.18#
|
|
|
10.19#
|
|
|
10.20#
|
|
|
10.21#
|
|
|
10.22#
|
|
|
10.23#
|
|
|
10.24#
|
|
|
10.25#
|
|
|
10.26#
|
|
|
10.27#
|
|
10.28#
|
|
|
10.29#
|
|
10.30#
|
|
|
10.31#
|
|
|
10.32#
|
|
|
10.33†
|
|
|
10.34
|
|
|
10.35
|
|
|
10.36
|
|
|
10.37 †
|
|
|
10.38
|
|
|
10.39 †
|
|
|
10.40 †
|
|
|
10.41 †
|
|
|
10.42
|
|
|
10.43
|
|
|
10.44 #
|
|
|
10.45 #
|
|
|
10.46 #
|
|
|
10.47 #
|
|
|
10.48 #
|
|
|
10.49 †
|
|
|
10.50
|
|
|
10.51 #
|
|
|
10.52 #
|
|
|
10.53 #
|
|
|
10.54 #
|
|
|
10.55 ±*
|
|
|
10.56 ±*
|
|
|
21.1*
|
|
|
23.1*
|
|
|
31.1*
|
|
|
31.2*
|
|
|
32.1*
|
|
|
32.2*
|
|
|
101*
|
|
The following financial information from the Annual report on Form 10-K for the fiscal year ended June 30, 2018, formatted in XBRL (eXtensible Business Reporting Language) and furnished electronically herewith: (i) the Consolidated Balance Sheets; (ii) the Consolidated Statements of Comprehensive Loss; (iii) the Consolidated Statements of Changes in Stockholders’ Equity (Deficit); (iv) the Consolidated Statements of Cash Flows; and (v) the Notes to Consolidated Financial Statements.
|
|
#
|
Management contract or compensatory plan or arrangement required to be filed as an exhibit to this Form 10-K pursuant to Item 15(a)(3) of Form 10-K.
|
±
|
Confidential treatment has been requested for certain portions of this exhibit. The confidential portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.
|
|
IMMUNOMEDICS, INC.
|
|||
|
|
|
|
|
Date: August 23, 2018
|
By:
|
/s/Michael Garone
|
||
|
|
Michael Garone
|
||
|
|
Chief Financial Officer (Principal Financial Accounting Officer)
|
|
|
|
|
|
Signature
|
|
Title
|
|
Date
|
|
|
|
|
|
/s/Dr. Behzad Aghazadeh
|
|
Chairman of the Board, Director
|
|
August 23, 2018
|
Dr. Behzad Aghazadeh
|
|
|
|
|
|
|
|
|
|
/s/Dr. Khalid Islam
|
|
Director
|
|
August 23, 2018
|
Dr. Khalid Islam
|
|
|
|
|
|
|
|
|
|
/s/Scott Canute
|
|
Director
|
|
August 23, 2018
|
Scott Canute
|
|
|
|
|
|
|
|
|
|
/s/Peter Barton Hutt
|
|
Director
|
|
August 23, 2018
|
Peter Barton Hutt
|
|
|
|
|
|
|
|
|
|
/s/Michael Pehl
|
|
Chief Executive Officer, Director
|
|
August 23, 2018
|
Michael Pehl
|
|
(Principal Executive Officer)
|
|
|
|
|
|
|
|
/s/Michael Garone
|
|
Chief Financial Officer (Principal
|
|
August 23, 2018
|
Michael Garone
|
|
Financial and Accounting Officer)
|
|
|
|
|
|
|
|
1.
|
Agreement.
The Parties will use reasonably diligent efforts in good faith to negotiate, execute, and deliver the Agreement on or before [***], unless extended by mutual agreement. The Parties agree to conduct the negotiations on a confidential basis.
|
2.
|
Binding Forecast.
The quantities of Product identified in Table 1 in
Exhibit B
represent the Parties’ current binding commitment (the “
Binding Forecast
”) for the manufacture and purchase of [***] Batches of bulk drug substance (“
DS
”) and [***] Batches of drug product (“
DP
”) distributed during each calendar quarter of 2018 at the prices agreed in the Proposal. The volumes of [***] Batches of DS and [***] Batch of DP specifically set forth in Table 2 of Exhibit 2 correspond to the minimum quantities for 2018 (the “
Minimum Quantities
”). Upon execution of this LOI, Immunomedics shall issue separate purchase orders (each a “
Purchase Order
”) for the Minimum Quantities of Product and for the Material Costs (as defined below in Section 5). The Purchase Order shall specify each manufacturing dates within such calendar quarter respectively for DS or DP, as set forth in Table 1. As used herein, “
Batch
” with respect to DS shall mean theoretical [***] Liters (10mg/mL per vial) and “
Batch
” with respect to DP shall mean theoretical [***] vials.
|
3.
|
Financial Obligations.
Throughout the term of this LOI [***], as distributed according to the manufacturing dates identified by the Parties, then Immunomedics is obligated to pay [***] per cent ([***]%) of the capacity reserved for the Binding Forecast at the price set forth in the Proposal, as amended from time to time, in accordance with the terms set forth in this Section 3. For clarity, the price for capacity reservation for any Batch of DS is €[***] and for any Batch of DP is €[***]. In accordance with the provisions of this LOI, the Parties hereby agree that should Immunomedics not utilize the capacity reserved by BSP for the manufacture of the Minimum Quantities, then Immunomedics shall pay to BSP an amount equal to the product of (i) the difference between (A) the aggregate quantity of Product set forth in the Binding Forecast limited to the Minimum Quantities of Product for such calendar year, less (B) the aggregate quantity of Product ordered by Immunomedics for delivery in such calendar year (such difference, the “
Order Shortfall
”), multiplied by (ii) the prices applicable to the Order Shortfall for such calendar year (i.e. €[***] for any Batch of DS and €[***] for any Batch of DP). In addition, Immunomedics shall pay to BSP an amount equal to [***]
|
4.
|
Intermediates.
Should the intermediates (i.e. toxin and mAb) not be available to be released at BSP at least four (4) weeks before the manufacturing date then Immunomedics shall immediately notify BSP thereof. Promptly thereafter, the Parties shall meet to discuss in good faith if BSP can comply with the original schedule using its best efforts to do so, and if BSP cannot comply with the original schedule, BSP shall use best efforts to adjust the manufacturing in accordance with the terms of this LOI and with BSP’s production plan. Should the adjustment of manufacturing not be possible, the relevant production shall be cancelled and Immunomedics shall remain obligated to pay such part of unused capacity; provided that BSP is unable to fill the unused capacity with work from a third party after using best efforts to do so.
|
5.
|
Payment.
BSP will submit invoices upon completion of the Services at the issuance of the Certificate of Analysis by BSP. The material costs for an amount estimated (in good faith) to be equal to Euro [***] (€ [***]) (the “
Material Costs
”) shall be paid separately [***] by Immunomedics immediately upon receipt of the invoice by BSP. Unless otherwise agreed by the Parties, BSP shall promptly return., at Immunomedics’ costs any material paid in advance by Immunomedics and not used by BSP in connection with the manufacture of the quantity of Product set forth in the Binding Forecast for the calendar year 2018 and which cannot be used for the manufacturing of Product under any other agreement between the Parties.
|
6.
|
Compliance
.
BSP represents and warrants that it will use its best efforts and exercise due care and sound business judgment in performing the services and it will carry out the Services hereunder in compliance with the current GMP, applicable laws, BSP’s standard operating procedures and any Immunomedics specifications and/or procedures agreed upon in writing by the Parties. BSP shall reserve appropriate resources required for the scope of work as set forth herein. Any non-conformance in Product supplied hereunder shall be governed by that certain Master Clinical Supply and Services Agreement between the parties dated as of April 12, 2018, unless and until the Agreement is executed, in which event the Agreement shall govern.
|
7.
|
Authority.
The Parties further represent and warrant that they have the corporate power, authority and legal right to enter into this LOI and to perform its obligations.
|
8.
|
Other provisions.
This LOI, together with the Mutual Confidential Disclosure Agreement dated October 13, 2014 (“
MCDA
”) represent the entire agreement among the Parties with respect to the subject matter hereof. The Parties agree that all information provided by the Parties regarding the transactions outlined herein, as well as each Party’s business information, processes and standard operating procedures, shall be proprietary of such Party, held in strict confidence by the other Party, shall not be used by the receiving Party except as strictly required for the purposes of this LOI and shall not be disclosed to any third party without the prior written consent of the other Party. In the event that either Party determines that applicable securities laws require disclosure of Confidential Information (including this LOI), such Party shall promptly notify the other and the Parties shall cooperate in making a disclosure (joint disclosure if necessary) which shall meet the requirements of the applicable securities laws.
|
9.
|
Term.
This LOI shall take effect as of the Effective Date and shall continue until the earliest of (i) the date of the completion of the activities specified in the Proposal, or (ii) the effective date of the Agreement, unless otherwise agreed in writing by the Parties.
|
10.
|
Prevalence.
Upon its execution, the Agreement will supersede this LOI and shall govern the terms of the project initiated by virtue of this LOI. The Agreement shall include such other terms as are customary for such agreements, including without limitation, provisions relating to forecasting, acceptance and rejection, representation and warranties, indemnification, insurance, limitation of liability, termination, publicity, and allocation of intellectual property rights.
|
11.
|
Liability.
EXCEPT FOR BREACHES OF CONFIDENTIALITY UNDER SECTION 8, IT IS UNDERSTOOD AND AGREED THAT NEITHER OF THE PARTIES SHALL BE LIABLE TOWARDS THE OTHER FOR INDIRECT, SPECIAL, PUNITIVE, EXEMPLARY, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING WITHOUT LIMITATION LOSS OF PROFITS OR REVENUES, REGARDLESS OF WHETHER SUCH DAMAGES WERE FORESEEABLE OR NOT.
|
12.
|
Taxes.
Each Party shall comply with its applicable taxation guidelines regarding filing and reporting for income tax purposes. Neither Party shall treat their relationship under this Agreement as a partnership or as a pass through entity for tax purposes.
|
13.
|
Law and Jurisdiction.
This LOI shall be governed by and construed in accordance with the laws of New York, United States of America, without regard to any conflicts-of-law provisions that directs the application to another jurisdiction’s law, and the United Nations Convention on Agreements for the International Sale of Goods is hereby excluded. Both Parties hereby submit to the exclusive jurisdiction of the federal and state courts located in the State of New York, U.S.A.
|
14.
|
General.
This LOI may be executed in one or more counterparts (including electronic counterparts), each of which shall be deemed to be an original document, but all such separate counterparts shall constitute only this LOI. The Parties shall perform their obligations under this LOI as independent contractors and nothing contained in this LOI shall be construed to be inconsistent with such relationship or status. The Parties shall neither amend this LOI, except by mutual written agreement nor assign the rights and/or obligations under this LOI to any third party in any manner without the prior written consent of the other Party.
|
BSP Pharmaceuticals S.p.A
|
|
Immunomedics, Inc.
|
||
|
|
|||
By:
|
/s/ Aldo Braca
|
By:
|
/s/ Michael Pehl
|
|
|
Aldo Braca
|
|
Michael Pehl
|
|
Title:
|
President & CEO
|
Title:
|
Chief Executive Officer
|
|
Date:
|
July 5, 2018
|
Date
|
July 3, 2018
|
Year 2018
|
|
Conjugation Batches
|
Fill-Finish Batches
|
[***]
|
[***]
|
`
|
|
[***]
|
[***]
|
[***]
|
|
[***]
|
[***]
|
[***]
|
|
[***]
|
[***]
|
[***]
|
|
[***]
|
|
[***]
|
|
Year 2018
|
|
Conjugation Batches
|
Fill-Finish Batches
|
[***]
|
[***]
|
[***]
|
|
[***]
|
|
[***]
|
|
[***]
|
Item
|
PO Issuance
|
Invoice Issuance
|
Payment
|
|
[***]
|
[***]
|
LOI Execution
|
LOI approval
|
[***]
|
[***]
|
[***]
|
|
September 30, 2018: [***]
November 30, 2018: [***]
|
[***]
|
[***] DS batches
|
LOI Execution
|
CoA issuance
|
[***]
|
|
[***] DP batch
|
[***] /batch
|
LOI Execution
|
CoA issuance
|
[***]
|
Milestone
|
|
Payment
|
[***]
|
|
$[***]
|
[***]
|
|
$[***]
|
[***]
|
|
$[***]
|
[***]
|
|
$[***]
|
TSRI:
|
LICENSEE:
|
|
|
THE SCRIPPS RESEARCH INSTITUTE
|
IMMUNOMEDICS, INC.
|
|
|
By:/
s/Matt Tremblay
|
By:
/s/Michael Garone
|
Name: Matt Tremblay
|
Name: Michael Garone
|
Title: Vice President, BD
|
Title: Chief Financial Officer
|
|
|
|
|
|
|
Benchmark
|
Anticipated date of benchmark
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
|
|
|
|
|
|
|
|
|
|
|
|
●
|
Immunomedics, B.V. (Netherlands)
|
Wholly owned subsidiary of Immunomedics, Inc.
|
|
|
|
●
|
Immunomedics GmbH (Germany)
|
Wholly owned subsidiary of Immunomedics, Inc.
|
|
|
|
●
|
IBC Pharmaceuticals, Inc. (Delaware)
|
Majority owned subsidiary of Immunomedics, Inc.
|
1.
|
I have reviewed the annual report on Form 10-K of Immunomedics, Inc.;
|
2.
|
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;
|
3.
|
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;
|
4.
|
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:
|
(a)
|
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;
|
(b)
|
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;
|
(c)
|
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
|
(d)
|
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
|
5.
|
The registrant’s other certifying officer 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):
|
(a)
|
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
|
(b)
|
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.
|
Date: August 23, 2018
|
|
|
|
/s/Michael Pehl
|
|
Michael Pehl
|
|
Chief Executive Officer
|
|
1.
|
I have reviewed the annual report on Form 10-K of Immunomedics, Inc.;
|
2.
|
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;
|
3.
|
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;
|
4.
|
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:
|
(a)
|
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;
|
(b)
|
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;
|
(c)
|
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
|
(d)
|
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
|
5.
|
The registrant’s other certifying officer 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):
|
(a)
|
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
|
(b)
|
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.
|
Date: August 23, 2018
|
|
/s/Michael Garone
|
|
Michael Garone
|
|
Chief Financial Officer
|
|
|
/s/Michael Pehl
|
|
Michael Pehl
|
|
Chief Executive Officer
|
|
/s/Michael Garone
|
|
Michael Garone
|
|
Chief Financial Officer
|