Large Accelerated Filer
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Accelerated Filer
þ
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Non-Accelerated Filer
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Smaller Reporting Company
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(do not check if smaller reporting company)
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Page
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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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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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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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Item 15.
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Drug Candidate
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Target/Indication
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Partner
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Clinical Status
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Binimetinib
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MEK inhibitor for cancer
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Pierre Fabre
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Phase 3
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Encorafenib
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BRAF inhibitor for cancer
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Pierre Fabre
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Phase 3
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Filanesib
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Kinesin spindle protein, or KSP, inhibitor for multiple myeloma
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Phase 2
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ARRY-797
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p38 inhibitor for Lamin A/C-related dilated cardiomyopathy
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Phase 2
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Selumetinib
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MEK inhibitor for cancer
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AstraZeneca, PLC
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Phase 3
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ASC08/Danoprevir
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Protease inhibitor for Hepatitis C virus
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Roche Holding AG
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Phase 3
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ASLAN001/Varlitinib
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Pan-HER2 inhibitor for gastric or breast cancer
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ASLAN Pharmaceuticals Pte Ltd.
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Phase 2
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Ipatasertib/GDC-0068
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AKT inhibitor for cancer
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Genentech, Inc.
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Phase 2
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Motolimod/VTX-2337
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Toll-like receptor for cancer
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VentiRx Pharmaceuticals, Inc.
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Phase 2
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Prexasertib/LY2606368
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Chk-1 inhibitor for cancer
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Eli Lilly and Company
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Phase 2
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LOXO-101
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PanTrk inhibitor for cancer
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Loxo Oncology, Inc.
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Phase 2
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ONT-380/ARRY-380
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HER2 inhibitor for breast cancer
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Cascadian Therapeutics
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Phase 2
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GDC-0575
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Chk-1 inhibitor for cancer
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Genentech, Inc.
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Phase 1
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GDC-0994
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ERK inhibitor for cancer
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Genentech, Inc.
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Phase 1
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ARRY-382
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CSF1R inhibitor for cancer
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Phase 1
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•
|
Median OS was 12.4 and 13.1 months for the doublet and alpelisib-containing triplet regimens, respectively.
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•
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Median PFS was 4.2 and 5.4 months for the doublet and alpelisib-containing triplet regimens, respectively.
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•
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ORR was 22 percent and 27 percent for the doublet and alpelisib-containing triplet regimens, respectively.
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•
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Grade 3 or 4 adverse events occurred in greater than 10 percent of patients and included anemia, hyperglycemia and increased lipase.
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•
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Confirmed ORR was 15 percent (95% CI, 11-20 percent) in patients receiving binimetinib vs. 7 percent (95% CI, 3-13 percent) in patients receiving dacarbazine.
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•
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DCR for patients receiving binimetinib was 58 percent (95% CI, 52-64 percent) vs. 25 percent (95% CI, 18-33 percent) for patients receiving dacarbazine.
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•
|
mOS was estimated at 11.0 months in patients receiving binimetinib vs. 10.1 months for patients treated with dacarbazine [(HR) = 1.0 (95% CI 0.75-1.33), p=0.499].
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•
|
ASLAN
– We entered into a Collaboration and License Agreement with ASLAN in July 2011 to develop Array's pan-HER inhibitor, Varlitinib/ASLAN001/ARRY-543, which is currently in Phase 1 and 2 clinical trials in patients with gastric cancer, breast cancer or cholangiocarcinoma.
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•
|
AstraZeneca
– In December 2003, we entered into a Collaboration and License Agreement with AstraZeneca under which AstraZeneca received a license to three of our MEK inhibitors for cancer, including selumetinib, which is currently in numerous clinical trials, including two registration trials.
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•
|
Genentech
– We entered into a worldwide strategic Drug Discovery Collaboration Agreement with Genentech in January 2003, which was expanded in 2005, 2008, and 2009, and is focused on the discovery, development and commercialization of novel therapeutics. The most advanced drugs are ipatasertib/GDC-0068, an AKT inhibitor for cancer, which is currently in Phase 2 and GDC-0994, an ERK inhibitor for cancer, which is currently in Phase 1. We also entered into a License Agreement with Genentech in August 2011 for the development of each company's small molecule Chk-1 program in oncology. The program included Genentech's compound GDC-0425 (RG7602) and Array's compound GDC-0575 (previously known as ARRY-575). Genentech selected GDC-0575 to advance into further clinical trials in patients with cancer.
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•
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Roche Holding AG
– We entered into a Drug Discovery Collaboration Agreement with InterMune in 2002, which resulted in the joint discovery of ASC08 / danoprevir, a novel small molecule inhibitor of the Hepatitis C Virus NS3/4A protease. Roche Holding AG acquired ASC08 from InterMune in 2010 and partnered with Ascletis in 2013 to advance the program in greater China. Ascletis has recently advanced ASC08 in Phase 3 clinical trials in China .
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•
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Cascadian Therapeutics (previously named Oncothyreon)
– We entered into a Development and Commercialization Agreement with Cascadian Therapeutics in May 2013, to collaborate on the development and commercialization of ONT-380, an orally active, reversible and selective small-molecule HER2 inhibitor, for the treatment of cancer, including breast cancer. In December 2014, we granted Cascadian Therapeutics an exclusive license to develop, manufacture and commercialize ONT-380. The License Agreement replaces the 2013 agreement. Cascadian Therapeutics is continuing development of ONT-380 in a defined set of proof-of-concept trials in patients with metastatic breast cancer, including patients with brain metastases.
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•
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Loxo
– We entered into a Drug Discovery Collaboration Agreement with Loxo in July 2013 and granted Loxo exclusive rights to develop and commercialize certain Array-invented compounds targeted at the
tropomyosin kinase, or Trk, family of receptors, including LOXO-101, which is currently in a Phase 2 clinical trial.
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•
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VentiRx
– We entered into a Collaboration and License Agreement with VentiRx in February 2007 and granted VentiRx exclusive worldwide rights to certain molecules from our Toll-Like Receptor, or TLR, program, including VTX-2337, which is currently in Phase 2 clinical trials.
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•
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Invent targeted small molecule drugs that are either first-in-class or second generation drugs that have little or no competition, or demonstrate a competitive advantage over drugs currently on the market or in clinical development.
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•
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Develop and commercialize our drugs to maximize their overall value. As our first drug nears approval, we plan to build a therapeutically-focused sales force to commercialize or co-promote drugs we wholly own, or for which we retain development rights in major geographic areas.
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•
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Implement a partnering strategy in which we out-license drugs outside our therapeutic or geographic focus and partner select early-stage programs for continued research and development in exchange for research funding plus significant milestone payments and royalties.
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Estimated 2016
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||||
Type of Cancer
|
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New Cases
|
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Deaths
|
||
|
|
|
|
|
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Lung
|
|
224,390
|
|
|
158,080
|
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Breast
|
|
249,260
|
|
|
40,890
|
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Colorectal
|
|
134,490
|
|
|
49,190
|
|
Melanoma
|
|
76,380
|
|
|
10,130
|
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Thyroid
|
|
64,300
|
|
|
1,980
|
|
Pancreas
|
|
53,070
|
|
|
41,780
|
|
Ovarian
|
|
22,280
|
|
|
14,240
|
|
Stomach
|
|
26,370
|
|
|
10,730
|
|
Myeloma
|
|
30,330
|
|
|
12,650
|
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Gallbladder and Other Biliary
|
|
11,420
|
|
|
3,710
|
|
|
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892,290
|
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|
343,380
|
|
1.
|
Increased efficacy of current treatments, notably the leading targeted therapies, including the proteasome inhibitor Velcade® (bortezomib), and the IMiDs, Revlimid® (lenalidomide) and Thalomid® (thalidomide), leading to longer life expectancy and allowing for more drug therapy to be administered over the disease course;
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2.
|
Increased use of existing and new drug combinations, particularly combinations with Velcade and Revlimid, leading to higher overall regimen costs; and
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3.
|
Introduction and uptake of new, higher-cost therapies, particularly greater uptake of Revlimid and anticipated launch of premium priced next generation proteasome inhibitors and IMiDs such as Kyprolis® (carfilzomib) and Pomalyst® (pomalidomide).
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Phase
|
|
Objective
|
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Estimated Duration
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Discovery
|
|
Lead identification and target validation.
|
|
2 to 4 years
|
Preclinical
|
|
Initial toxicology for preliminary identification of risks for humans; gather early pharmacokinetic data.
|
|
1 to 2 years
|
Phase 1
|
|
Evaluate the safety and tolerability of the drug in human subjects and find the maximum tolerated dose. The pharmacokinetics of the drug are examined after single and multiple doses, the effects of food on the pharmacokinetics may be evaluated and drug metabolites may be monitored.
|
|
1 to 2 years
|
Phase 2
|
|
Evaluate effectiveness of the drug and its optimal dosage in patients; continue safety evaluation.
|
|
2 to 4 years
|
Phase 3
|
|
Confirm efficacy, dosage regime and safety profile of the drug in patients
|
|
2 to 4 years
|
NDA Preparation, Review and Approval
|
|
FDA review and approval to sell and market the drug under the approved labeling
|
|
1 to 2 years
|
•
|
Discovery Research — Biology, Pharmacology, Toxicology, Chemistry and Translational Medicine;
|
•
|
Process Research, Development, Formulation and Manufacturing (through collaborations, including with Accuratus Lab Services, Inc.); and
|
•
|
Clinical Development — Clinical Science, Clinical Operations, Drug Safety, Translational Medicine, Biostatistics and Data Management, Regulatory Affairs and Program Management.
|
•
|
partners may develop and commercialize, either alone or with others, products and services that are similar to, or competitive with, the products that are the subject of the collaboration with us;
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•
|
partners may not commit sufficient resources to the testing, marketing, distribution or other development of our drug candidates;
|
•
|
partners may not properly maintain or defend intellectual property rights we license to them or they may utilize our proprietary information in such a way as to invite litigation that could jeopardize or potentially invalidate our intellectual property or proprietary information or expose us to potential liability;
|
•
|
partners may encounter conflicts of interest, changes in business strategy or other business issues which could adversely affect their willingness or ability to fulfill their obligations to us (for example, pharmaceutical and biotechnology companies historically have re-evaluated their priorities following mergers and consolidations, which have been common in recent years in these industries);
|
•
|
partners are subject to many of the risks described under the heading below "
Risks Related to Our Industry
" and any adverse effects on our partners in connection with their regulatory obligations could have a material adverse effect on our business, financial condition and ability to commercialize our products; and
|
•
|
disputes may arise between us and our partners delaying or terminating the research, development or commercialization of our drug candidates, resulting in significant litigation or arbitration that could be time-consuming and expensive, or causing partners to act in their own self-interest and not in the interest of holders of our securities.
|
•
|
our ability to create valuable proprietary drugs targeting large market opportunities;
|
•
|
strategic decisions to allocate more of our resources to the further development of our proprietary programs and building our commercialization capabilities as our drugs advance;
|
•
|
research and spending priorities of potential licensing partners;
|
•
|
willingness of, and the resources available to, pharmaceutical and biotechnology companies to in-license drug candidates to fill their clinical pipelines;
|
•
|
the success or failure, and timing, of preclinical and clinical trials for our proprietary programs we intend to out-license; or
|
•
|
our ability or inability to generate proof-of-concept data and to agree with a potential partner on the value of proprietary drug candidates we are seeking to out-license, or on the related terms.
|
•
|
failure to achieve clinical trial results that indicate a candidate is effective in treating a specified condition or illness in humans;
|
•
|
presence of harmful side effects;
|
•
|
determination by the FDA that the submitted data do not satisfy the criteria for approval;
|
•
|
lack of commercial viability of the drug;
|
•
|
failure to acquire, on reasonable terms, intellectual property rights necessary for commercialization;
|
•
|
existence of alternative therapeutics that are more effective; and
|
•
|
if a drug candidate requires a companion diagnostic test for approval, failure to obtain approval for the companion diagnostic test.
|
•
|
provide sufficient safety, efficacy or other data regarding a drug candidate to support the commencement of a Phase 3 or other clinical trial;
|
•
|
reach agreement on acceptable terms with prospective contract manufacturers, CROs and trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different third parties;
|
•
|
select CROs, trial sites and, where necessary, contract manufacturers that do not encounter any regulatory compliance problems;
|
•
|
manufacture sufficient quantities of a product candidate for use in clinical trials;
|
•
|
obtain IRB approval to conduct a clinical trial at a prospective site;
|
•
|
recruit and enroll patients to participate in clinical trials, which can be impacted by many factors outside our or our partners’ control, including competition from other clinical trial programs for the same or similar indications;
|
•
|
retain patients who have initiated a clinical trial but may be prone to withdraw due to side effects from the therapy, lack of efficacy or personal issues; and
|
•
|
develop and validate a companion diagnostic test for a drug candidate that requires one.
|
•
|
failure to conduct the clinical trial in accordance with regulatory requirements, including GCP, or our protocols;
|
•
|
inspection of the clinical trial operations, trial sites or manufacturing facility by the FDA or other regulatory authorities resulting in findings of non-compliance and the imposition of a clinical hold;
|
•
|
unforeseen safety issues or results that do not demonstrate efficacy; and
|
•
|
lack of adequate funding to continue the clinical trial.
|
•
|
the federal Anti-Kickback Statute, which prohibits, among other things, knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, order or recommendation of
,
items or services for which payment may be made, in whole or in part, under federal healthcare programs, such as the Medicare and Medicaid programs. The term “remuneration” has been broadly interpreted to include anything of value, and the government can establish a violation of the Anti-Kickback Statute without proving that a person or entity had actual knowledge of the law or specific intent to violate it;
|
•
|
the federal civil False Claims Act, which prohibits, among other things, individuals or entities from knowingly presenting
,
or causing to be presented, false or fraudulent claims for payment of government funds or knowingly making, using or causing to be made or used, a false record or statement to get a false claim paid. There are also criminal penalties, including imprisonment and criminal fines, for making or presenting a false or fictitious or fraudulent claim to the federal government;
|
•
|
the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA), which created federal criminal laws that prohibit, among other actions, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program including private third-party payors;
|
•
|
the federal Physician Payment Sunshine Act, which requires manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program to report annually (with certain exceptions) to the Centers for Medicare & Medicaid Services, or CMS, information related to payments or other ‘‘transfers of value’’ made to physicians and teaching hospitals, and requires applicable manufacturers and group purchasing organizations to report annually to CMS ownership and investment interests held by physicians and their immediate family members and payments or other ‘‘transfers of value’’ to such physician owners;
|
•
|
the federal Foreign Corrupt Practices Act and similar anti-bribery laws in other jurisdictions, which generally prohibit companies and their intermediaries from making improper payments to government officials and/or other persons for the purpose of obtaining or retaining business; and
|
•
|
analogous state and foreign law equivalents of each of the above federal laws, such as anti-kickback and false claims laws some of which apply to items or services reimbursed by any third-party payor, including commercial insurers; state laws that require pharmaceutical manufacturers to comply with the industry’s voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; and state laws that require pharmaceutical manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts
.
|
•
|
demonstration of clinical effectiveness and safety;
|
•
|
potential advantages of our drug candidates over alternative treatments;
|
•
|
ability to offer our drug candidates for sale at competitive prices;
|
•
|
availability of adequate third-party reimbursement; and
|
•
|
effectiveness of marketing and distribution methods for the products.
|
•
|
availability or contamination of raw materials and components used in the manufacturing process, particularly those for which we have no other source or supplier;
|
•
|
capacity of our facilities or those of our contract manufacturers;
|
•
|
facility contamination by microorganisms or viruses or cross contamination;
|
•
|
compliance with regulatory requirements, including Form 483 notices and Warning Letters;
|
•
|
changes in forecasts of future demand;
|
•
|
timing and actual number of production runs;
|
•
|
production success rates and bulk drug yields; and
|
•
|
timing and outcome of product quality testing.
|
•
|
develop and implement drug discovery technologies that will result in the identification of higher quality drug candidates;
|
•
|
attract and retain experienced, high caliber scientists;
|
•
|
achieve timely, high-quality results at an acceptable cost; and
|
•
|
design, create and manufacture our chemical compounds in quantities, at purity levels and at costs that are acceptable to our partners.
|
ITEM 5.
|
MARKET FOR THE REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES
|
Fiscal Year Ended June 30, 2016
|
|
High
|
|
Low
|
||||
First Quarter
|
|
$
|
7.11
|
|
|
$
|
4.56
|
|
Second Quarter
|
|
$
|
5.48
|
|
|
$
|
3.83
|
|
Third Quarter
|
|
$
|
4.14
|
|
|
$
|
2.50
|
|
Fourth Quarter
|
|
$
|
3.85
|
|
|
$
|
2.74
|
|
|
|
|
|
|
||||
Fiscal Year Ended June 30, 2015
|
|
High
|
|
Low
|
||||
First Quarter
|
|
$
|
4.81
|
|
|
$
|
3.51
|
|
Second Quarter
|
|
$
|
5.04
|
|
|
$
|
2.98
|
|
Third Quarter
|
|
$
|
8.59
|
|
|
$
|
4.19
|
|
Fourth Quarter
|
|
$
|
8.04
|
|
|
$
|
6.16
|
|
|
6/30/2011
|
|
6/30/2012
|
|
6/30/2013
|
|
6/30/2014
|
|
6/30/2015
|
|
6/30/2016
|
||||||
Array BioPharma Inc.
|
100.00
|
|
|
154.91
|
|
|
202.68
|
|
|
203.57
|
|
|
321.88
|
|
|
158.93
|
|
NASDAQ Composite
|
100.00
|
|
|
105.82
|
|
|
122.71
|
|
|
158.94
|
|
|
179.80
|
|
|
174.60
|
|
NASDAQ Biotechnology
|
100.00
|
|
|
122.07
|
|
|
122.07
|
|
|
242.28
|
|
|
348.44
|
|
|
243.19
|
|
|
Year Ended June 30,
|
||||||||||||||||||
|
2016
|
|
2015
|
|
2014
|
|
2013
|
|
2012
|
||||||||||
Revenue
|
|
|
|
|
|
|
|
|
|
||||||||||
License and milestone revenue
|
$
|
3,876
|
|
|
$
|
20,367
|
|
|
$
|
25,111
|
|
|
$
|
56,726
|
|
|
$
|
71,249
|
|
Reimbursement revenue
|
107,330
|
|
|
7,020
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Collaboration and other revenue
|
26,673
|
|
|
24,522
|
|
|
16,967
|
|
|
12,854
|
|
|
13,886
|
|
|||||
Total revenue
|
137,879
|
|
|
51,909
|
|
|
42,078
|
|
|
69,580
|
|
|
85,135
|
|
|||||
Operating expenses
|
|
|
|
|
|
|
|
|
|
||||||||||
Cost of partnered programs
|
23,166
|
|
|
44,392
|
|
|
45,965
|
|
|
30,078
|
|
|
24,261
|
|
|||||
Research and development for proprietary programs
|
160,655
|
|
|
54,442
|
|
|
49,824
|
|
|
59,420
|
|
|
56,719
|
|
|||||
General and administrative
|
36,267
|
|
|
31,433
|
|
|
21,907
|
|
|
19,624
|
|
|
15,202
|
|
|||||
Total operating expenses
|
220,088
|
|
|
130,267
|
|
|
117,696
|
|
|
109,122
|
|
|
96,182
|
|
|||||
Gain on the Binimetinib and Encorafenib Agreements, net
|
—
|
|
|
80,010
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Gain on sale of CMC, net
|
—
|
|
|
1,641
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Income (loss) from operations
|
(82,209
|
)
|
|
3,293
|
|
|
(75,618
|
)
|
|
(39,542
|
)
|
|
(11,047
|
)
|
|||||
Other income (expense)
|
|
|
|
|
|
|
|
|
|
||||||||||
Realized gain from marketable securities, net
|
—
|
|
|
16,255
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Loss on prepayment of long-term debt, net
|
—
|
|
|
—
|
|
|
—
|
|
|
(11,197
|
)
|
|
(942
|
)
|
|||||
Interest income
|
243
|
|
|
68
|
|
|
77
|
|
|
55
|
|
|
32
|
|
|||||
Interest expense
|
(10,874
|
)
|
|
(10,247
|
)
|
|
(9,716
|
)
|
|
(11,258
|
)
|
|
(11,624
|
)
|
|||||
Total other income (expense), net
|
(10,631
|
)
|
|
6,076
|
|
|
(9,639
|
)
|
|
(22,400
|
)
|
|
(12,534
|
)
|
|||||
Net income (loss)
|
$
|
(92,840
|
)
|
|
$
|
9,369
|
|
|
$
|
(85,257
|
)
|
|
$
|
(61,942
|
)
|
|
$
|
(23,581
|
)
|
Weighted average shares outstanding – basic
|
142,964
|
|
|
136,679
|
|
|
123,403
|
|
|
107,794
|
|
|
70,619
|
|
|||||
Weighted average shares outstanding – diluted
|
142,964
|
|
|
141,692
|
|
|
123,403
|
|
|
107,794
|
|
|
70,619
|
|
|||||
Net earnings (loss) per share – basic
|
$
|
(0.65
|
)
|
|
$
|
0.07
|
|
|
$
|
(0.69
|
)
|
|
$
|
(0.57
|
)
|
|
$
|
(0.33
|
)
|
Net earnings (loss) per share – diluted
|
$
|
(0.65
|
)
|
|
$
|
0.07
|
|
|
$
|
(0.69
|
)
|
|
$
|
(0.57
|
)
|
|
$
|
(0.33
|
)
|
|
June 30,
|
||||||||||||||||||
|
2016
|
|
2015
|
|
2014
|
|
2013
|
|
2012
|
||||||||||
Cash, cash equivalents, marketable securities and accounts receivable
|
$
|
149,840
|
|
|
$
|
185,129
|
|
|
$
|
117,067
|
|
|
$
|
118,301
|
|
|
$
|
90,725
|
|
Working capital
|
102,867
|
|
|
148,623
|
|
|
68,943
|
|
|
70,732
|
|
|
16,935
|
|
|||||
Total assets
|
168,900
|
|
|
198,207
|
|
|
136,625
|
|
|
133,335
|
|
|
107,129
|
|
|||||
Long-term debt, net
|
113,655
|
|
|
107,280
|
|
|
101,524
|
|
|
96,368
|
|
|
91,312
|
|
|||||
Total stockholders' equity (deficit)
|
(37,932
|
)
|
|
42,653
|
|
|
(25,721
|
)
|
|
(21,909
|
)
|
|
(85,806
|
)
|
ITEM 7.
|
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
|
|
Drug Candidate
|
|
Target/Indication
|
|
Partner
|
|
Clinical Status
|
|
Binimetinib
|
|
MEK inhibitor for cancer
|
|
Pierre Fabre
|
|
Phase 3
|
|
Encorafenib
|
|
BRAF inhibitor for cancer
|
|
Pierre Fabre
|
|
Phase 3
|
|
Filanesib
|
|
Kinesin spindle protein, or KSP, inhibitor for multiple myeloma
|
|
|
|
Phase 2
|
|
ARRY-797
|
|
p38 inhibitor for Lamin A/C-related dilated cardiomyopathy
|
|
|
|
Phase 2
|
|
Selumetinib
|
|
MEK inhibitor for cancer
|
|
AstraZeneca, PLC
|
|
Phase 3
|
|
ASC08/Danoprevir
|
|
Protease inhibitor for Hepatitis C virus
|
|
Roche Holding AG
|
|
Phase 3
|
|
ASLAN001/Varlitinib
|
|
Pan-HER2 inhibitor for gastric or breast cancer
|
|
ASLAN Pharmaceuticals Pte Ltd.
|
|
Phase 2
|
|
Ipatasertib/GDC-0068
|
|
AKT inhibitor for cancer
|
|
Genentech, Inc.
|
|
Phase 2
|
|
Motolimod/VTX-2337
|
|
Toll-like receptor for cancer
|
|
VentiRx Pharmaceuticals, Inc.
|
|
Phase 2
|
|
Prexasertib/
LY2606368
|
|
Chk-1 inhibitor for cancer
|
|
Eli Lilly and Company
|
|
Phase 2
|
|
LOXO-101
|
|
PanTrk inhibitor for cancer
|
|
Loxo Oncology, Inc.
|
|
Phase 2
|
|
ONT-380/ARRY-380
|
|
HER2 inhibitor for breast cancer
|
|
Cascadian Therapeutics
|
|
Phase 2
|
|
GDC-0575
|
|
Chk-1 inhibitor for cancer
|
|
Genentech, Inc.
|
|
Phase 1b
|
|
GDC-0994
|
|
ERK inhibitor for cancer
|
|
Genentech, Inc.
|
|
Phase 1
|
|
ARRY-382
|
|
CSF1R inhibitor for cancer
|
|
|
|
Phase 1
|
•
|
Median OS was 12.4 and 13.1 months for the doublet and alpelisib-containing triplet regimens, respectively.
|
•
|
Median PFS was 4.2 and 5.4 months for the doublet and alpelisib-containing triplet regimens, respectively.
|
•
|
ORR was 22 percent and 27 percent for the doublet and alpelisib-containing triplet regimens, respectively.
|
•
|
Grade 3 or 4 adverse events occurred in greater than 10 percent of patients and included anemia, hyperglycemia and increased lipase.
|
•
|
Confirmed ORR was 15 percent (95% CI, 11-20 percent) in patients receiving binimetinib vs. 7 percent (95% CI, 3-13 percent) in patients receiving dacarbazine.
|
•
|
DCR for patients receiving binimetinib was 58 percent (95% CI, 52-64 percent) vs. 25 percent (95% CI, 18-33 percent) for patients receiving dacarbazine.
|
•
|
mOS was estimated at 11.0 months in patients receiving binimetinib vs. 10.1 months for patients treated with dacarbazine [(HR) = 1.0 (95% CI 0.75-1.33), p=0.499].
|
|
|
|
|
|
|
|
Change
|
|
Change
|
||||||||||||||||
|
Year Ended June 30,
|
|
2016 vs. 2015
|
|
2015 vs. 2014
|
||||||||||||||||||||
|
2016
|
|
2015
|
|
2014
|
|
$
|
|
%
|
|
$
|
|
%
|
||||||||||||
License and milestone revenue
|
$
|
3,876
|
|
|
$
|
20,367
|
|
|
$
|
25,111
|
|
|
$
|
(16,491
|
)
|
|
(81
|
)%
|
|
$
|
(4,744
|
)
|
|
(19
|
)%
|
Reimbursement revenue
|
107,330
|
|
|
7,020
|
|
|
—
|
|
|
100,310
|
|
|
1,429
|
%
|
|
7,020
|
|
|
(a)
|
||||||
Collaboration and other revenue
|
26,673
|
|
|
24,522
|
|
|
16,967
|
|
|
2,151
|
|
|
9
|
%
|
|
7,555
|
|
|
45
|
%
|
|||||
Total revenue
|
$
|
137,879
|
|
|
$
|
51,909
|
|
|
$
|
42,078
|
|
|
$
|
85,970
|
|
|
166
|
%
|
|
$
|
9,831
|
|
|
23
|
%
|
|
|
|
|
|
|
|
Change
|
|
Change
|
||||||||||||||||
|
Year Ended June 30,
|
|
2016 vs. 2015
|
|
2015 vs. 2014
|
||||||||||||||||||||
|
2016
|
|
2015
|
|
2014
|
|
$
|
|
%
|
|
$
|
|
%
|
||||||||||||
Salaries, benefits and share-based compensation
|
$
|
20,047
|
|
|
$
|
14,697
|
|
|
$
|
18,443
|
|
|
$
|
5,350
|
|
|
36
|
%
|
|
$
|
(3,746
|
)
|
|
(20
|
)%
|
Outsourced services and consulting
|
130,229
|
|
|
28,433
|
|
|
18,170
|
|
|
101,796
|
|
|
358
|
%
|
|
10,263
|
|
|
56
|
%
|
|||||
Laboratory supplies
|
4,714
|
|
|
4,513
|
|
|
5,756
|
|
|
201
|
|
|
4
|
%
|
|
(1,243
|
)
|
|
(22
|
)%
|
|||||
Facilities and depreciation
|
3,657
|
|
|
5,229
|
|
|
6,069
|
|
|
(1,572
|
)
|
|
(30
|
)%
|
|
(840
|
)
|
|
(14
|
)%
|
|||||
Other
|
2,008
|
|
|
1,570
|
|
|
1,386
|
|
|
438
|
|
|
28
|
%
|
|
184
|
|
|
13
|
%
|
|||||
Total research and development expenses
|
$
|
160,655
|
|
|
$
|
54,442
|
|
|
$
|
49,824
|
|
|
$
|
106,213
|
|
|
195
|
%
|
|
$
|
4,618
|
|
|
9
|
%
|
|
|
|
|
|
|
|
Change
|
|
Change
|
||||||||||||||||
|
Year Ended June 30,
|
|
2016 vs. 2015
|
|
2015 vs. 2014
|
||||||||||||||||||||
|
2016
|
|
2015
|
|
2014
|
|
$
|
|
%
|
|
$
|
|
%
|
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
General and administrative expenses
|
$
|
36,267
|
|
|
$
|
31,433
|
|
|
$
|
21,907
|
|
|
$
|
4,834
|
|
|
15
|
%
|
|
$
|
9,526
|
|
|
43
|
%
|
|
|
|
|
|
|
|
Change
|
|
Change
|
||||||||||||||||
|
Year Ended June 30,
|
|
2016 vs. 2015
|
|
2015 vs. 2014
|
||||||||||||||||||||
|
2016
|
|
2015
|
|
2014
|
|
$
|
|
%
|
|
$
|
|
%
|
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Realized gain from marketable securities, net
|
$
|
—
|
|
|
$
|
16,255
|
|
|
$
|
—
|
|
|
$
|
(16,255
|
)
|
|
—
|
%
|
|
$
|
16,255
|
|
|
—
|
%
|
Interest income
|
243
|
|
|
68
|
|
|
77
|
|
|
175
|
|
|
257
|
%
|
|
(9
|
)
|
|
(12
|
)%
|
|||||
Interest expense
|
(10,874
|
)
|
|
(10,247
|
)
|
|
(9,716
|
)
|
|
(627
|
)
|
|
(6
|
)%
|
|
(531
|
)
|
|
(5
|
)%
|
|||||
Total other income (expense), net
|
$
|
(10,631
|
)
|
|
$
|
6,076
|
|
|
$
|
(9,639
|
)
|
|
$
|
(16,707
|
)
|
|
(275
|
)%
|
|
$
|
15,715
|
|
|
163
|
%
|
|
Year Ended June 30,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
Comerica Term Loan
|
|
|
|
|
|
||||||
Simple interest
|
$
|
501
|
|
|
$
|
480
|
|
|
$
|
479
|
|
Amortization of fees paid for letters of credit
|
31
|
|
|
44
|
|
|
48
|
|
|||
Total interest expense on the Comerica term loan
|
532
|
|
|
524
|
|
|
527
|
|
|||
|
|
|
|
|
|
||||||
Convertible Senior Notes
|
|
|
|
|
|
||||||
Contractual interest
|
3,967
|
|
|
3,968
|
|
|
3,979
|
|
|||
Amortization of debt discount
|
6,033
|
|
|
5,447
|
|
|
4,932
|
|
|||
Amortization of debt issuance costs
|
342
|
|
|
308
|
|
|
278
|
|
|||
Total interest expense on the convertible senior notes
|
10,342
|
|
|
9,723
|
|
|
9,189
|
|
|||
Total interest expense
|
$
|
10,874
|
|
|
$
|
10,247
|
|
|
$
|
9,716
|
|
•
|
In December 2009, we received a
$60 million
up-front payment from Amgen under a Collaboration and License Agreement.
|
•
|
During May and June 2010, we received a total of
$45 million
in up-front and milestone payments under a License Agreement with Novartis.
|
•
|
In December 2010, we received a
$10 million
milestone payment under a Drug Discovery and Development Agreement with Celgene.
|
•
|
In May 2011, we received a
$10 million
milestone payment under a License Agreement with Novartis.
|
•
|
In September 2011, we received a
$28 million
up-front payment under a Drug Discovery Collaboration Agreement with Genentech.
|
•
|
In June 2012, we received an
$8.5 million
milestone payment from Amgen under a Collaboration and License Agreement.
|
•
|
In June 2013, we received a
$10 million
up-front payment under a Development and Commercialization Agreement with Cascadian Therapeutics.
|
•
|
In July 2013, we received an
$11 million
up-front payment under a Drug Discovery and Development Option and License Agreement with Celgene.
|
•
|
In August 2013, we received a
$5 million
milestone payment under a License Agreement with Novartis.
|
•
|
In November 2013, we received a
$5 million
milestone payment under a Collaboration and License Agreement with AstraZeneca.
|
•
|
In December 2014, we received a
$20 million
up-front payment under a License Agreement with Cascadian Therapeutics.
|
•
|
In January 2016, we received a $30 million up-front payment under a Development and Commercialization Agreement with Pierre Fabre.
|
•
|
In April 2016, we received a $12 million up-front payment under a Collaboration and License Agreement with Asahi Kasai.
|
|
June 30,
|
|
Change
|
|
Change
|
||||||||||||||
|
2016
|
|
2015
|
|
2014
|
|
2016 vs. 2015
|
|
2015 vs. 2014
|
||||||||||
|
|
|
|
|
|
|
|
|
|
||||||||||
Cash and cash equivalents
|
$
|
56,598
|
|
|
$
|
55,691
|
|
|
$
|
68,591
|
|
|
$
|
907
|
|
|
$
|
(12,900
|
)
|
Marketable securities – short-term
|
53,344
|
|
|
122,635
|
|
|
42,407
|
|
|
(69,291
|
)
|
|
80,228
|
|
|||||
Marketable securities – long-term
|
596
|
|
|
496
|
|
|
640
|
|
|
100
|
|
|
(144
|
)
|
|||||
Accounts receivable
|
39,302
|
|
|
6,307
|
|
|
5,429
|
|
|
32,995
|
|
|
878
|
|
|||||
Total
|
$
|
149,840
|
|
|
$
|
185,129
|
|
|
$
|
117,067
|
|
|
$
|
(35,289
|
)
|
|
$
|
68,062
|
|
|
Year Ended June 30,
|
|
Change
|
|
Change
|
||||||||||||||
|
2016
|
|
2015
|
|
2014
|
|
2016 vs. 2015
|
|
2015 vs. 2014
|
||||||||||
Cash flows provided by (used in):
|
|
|
|
|
|
|
|
|
|
||||||||||
Operating activities
|
$
|
(70,090
|
)
|
|
$
|
(5,793
|
)
|
|
$
|
(71,682
|
)
|
|
$
|
(64,297
|
)
|
|
$
|
65,889
|
|
Investing activities
|
66,027
|
|
|
(58,049
|
)
|
|
2,482
|
|
|
124,076
|
|
|
(60,531
|
)
|
|||||
Financing activities
|
4,970
|
|
|
50,942
|
|
|
77,055
|
|
|
(45,972
|
)
|
|
(26,113
|
)
|
|||||
Total
|
$
|
907
|
|
|
$
|
(12,900
|
)
|
|
$
|
7,855
|
|
|
$
|
13,807
|
|
|
$
|
(20,755
|
)
|
|
Less than
1 Year
|
|
1 to 3
Years
|
|
4 to 5
Years
|
|
Over 5
Years
|
|
Total
|
||||||||||
|
|
|
|
|
|
|
|
|
|
||||||||||
Debt obligations (1)
|
$
|
—
|
|
|
$
|
14,550
|
|
|
$
|
132,250
|
|
|
$
|
—
|
|
|
$
|
146,800
|
|
Interest on debt obligations (2)(3)(4)
|
4,477
|
|
|
8,105
|
|
|
3,648
|
|
|
—
|
|
|
16,230
|
|
|||||
Operating lease commitments (2)
|
3,750
|
|
|
7,079
|
|
|
7,232
|
|
|
14,347
|
|
|
32,408
|
|
|||||
Minimum revenue guarantee (2)(5)
|
1,875
|
|
|
—
|
|
|
|
|
|
|
1,875
|
|
|||||||
Purchase obligations (2)(6)
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Total
|
$
|
10,102
|
|
|
$
|
29,734
|
|
|
$
|
143,130
|
|
|
$
|
14,347
|
|
|
$
|
197,313
|
|
|
|
|
|
|
|
|
|
|
|
(1)
|
Reflected in the accompanying balance sheets.
|
(2)
|
These obligations are not reflected in the accompanying balance sheets.
|
(3)
|
Interest on the variable debt obligation under the term loan with Comerica is calculated at 3.5%, the interest rate in effect as of
June 30, 2016
.
|
(4)
|
Interest on the 2020 Notes is calculated at 3.00%, which is the coupon rate.
|
(5)
|
This item relates to the sale of our CMC activities. For more information, see
Note 4 - Sale of CMC
to the accompanying audited financial statements included elsewhere in this Annual Report on Form 10-K.
|
(6)
|
We have open purchase orders for
$265.0 million
, which include
$177.8 million
for CROs,
$78.0 million
for other outsourced services for clinical trials and research and development costs and
$9.2 million
for all other purchase commitments. Included in these amounts are purchase orders totaling
$170.8 million
to complete the Novartis transitioned studies, which we expect will be reimbursed to us by Novartis. Substantially all of our purchase orders may be canceled without significant penalty to Array.
|
ITEM 9.
|
CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
|
ITEM 12.
|
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
|
|
|
(a)
|
|
(b)
|
|
(c)
|
|||
Plan Category
|
|
Number of securities to be issued upon exercise of outstanding options, warrants and rights
|
|
Weighted-average exercise price of outstanding options, warrants and rights
|
|
Number of securities remaining available for future issuance under equity compensation plans excluding securities reflected in column (a)
|
|||
|
|
|
|
|
|
|
|||
Stock Option and Incentive Plan (1) (2)
|
|
12,479,695
|
|
|
$4.80
|
|
19,228,677
|
|
|
|
|
|
|
|
|
|
|||
ESPP
|
|
—
|
|
|
—
|
|
|
586,106
|
|
|
|
|
|
|
|
|
|||
Total
|
|
12,479,695
|
|
|
|
|
19,814,783
|
|
|
|
|
|
|
|
|
|
(1)
|
Consists of
11,647,595
stock options with a weighted average exercise price of
$4.80
and
832,100
restricted stock units.
|
(2)
|
The shares available for issuance under the Stock Option and Incentive Plan are increased automatically by an amount equal to the difference between (a) 25% of our issued and outstanding shares of capital stock (on a fully diluted, as converted basis) and (b) the sum of the shares relating to outstanding option grants plus the shares available for future grants under such Stock Option and Incentive Plan. However, in no event shall the number of additional authorized shares determined pursuant to this formula exceed, when added to the number of shares of common stock outstanding and reserved for issuance under the Stock Option and Incentive Plan other than pursuant to this formula, under the ESPP and upon conversion or exercise of outstanding warrants, convertible securities or convertible debt, the total number of shares of common stock authorized for issuance under Array's Amended and Restated Certificate of Incorporation.
|
By:
|
/s/ RON SQUARER
|
|
Ron Squarer
|
|
Chief Executive Officer
|
Signature
|
|
Title
|
|
Date
|
|
|
|
|
|
|
|
|
|
|
/s/ RON SQUARER
|
|
Chief Executive Officer and Director
|
|
August 19, 2016
|
Ron Squarer
|
|
(Principal Executive Officer)
|
|
|
|
|
|
|
|
/s/ KYLE A. LEFKOFF
|
|
Chairman of the Board of Directors
|
|
August 19, 2016
|
Kyle A. Lefkoff
|
|
|
|
|
|
|
|
|
|
/s/ DAVID HORIN
|
|
|
|
August 19, 2016
|
David Horin
|
|
(Principal Accounting Officer)
|
|
|
|
|
|
|
|
/s/ CHARLES M. BAUM
|
|
Director
|
|
August 19, 2016
|
Charles M. Baum, M.D., Ph.D.
|
|
|
|
|
|
|
|
|
|
/s/ GWEN A. FYFE
|
|
Director
|
|
August 19, 2016
|
Gwen A. Fyfe, M.D.
|
|
|
|
|
|
|
|
|
|
/s/ JOHN A. ORWIN
|
|
Director
|
|
August 19, 2016
|
John A. Orwin
|
|
|
|
|
|
|
|
|
|
/s/ GIL J. VAN LUNSEN
|
|
Director
|
|
August 19, 2016
|
Gil J. Van Lunsen
|
|
|
|
|
|
|
|
|
|
Description
|
|
Page No.
|
|
|
|
|
||
|
||
|
||
|
||
|
||
|
||
|
||
|
By:
|
/s/ RON SQUARER
|
|
RON SQUARER
|
|
Chief Executive Officer
|
By:
|
/s/ DAVID HORIN
|
|
DAVID HORIN
|
|
Principal Accounting Officer
|
|
June 30,
|
||||||
|
2016
|
|
2015
|
||||
Assets
|
|
|
|
||||
Current assets
|
|
|
|
||||
Cash and cash equivalents
|
$
|
56,598
|
|
|
$
|
55,691
|
|
Marketable securities
|
53,344
|
|
|
122,635
|
|
||
Accounts receivable
|
39,302
|
|
|
6,307
|
|
||
Prepaid expenses and other current assets
|
6,057
|
|
|
6,414
|
|
||
Total current assets
|
155,301
|
|
|
191,047
|
|
||
|
|
|
|
||||
Long-term assets
|
|
|
|
||||
Marketable securities
|
596
|
|
|
496
|
|
||
Property and equipment, net
|
6,680
|
|
|
5,050
|
|
||
Other long-term assets
|
6,323
|
|
|
1,614
|
|
||
Total long-term assets
|
13,599
|
|
|
7,160
|
|
||
Total assets
|
$
|
168,900
|
|
|
$
|
198,207
|
|
|
|
|
|
||||
Liabilities and Stockholders' Equity
|
|
|
|
||||
Current liabilities
|
|
|
|
||||
Accounts payable
|
$
|
10,147
|
|
|
$
|
4,570
|
|
Accrued outsourcing costs
|
19,140
|
|
|
17,402
|
|
||
Accrued compensation and benefits
|
8,633
|
|
|
7,507
|
|
||
Other accrued expenses
|
1,068
|
|
|
2,714
|
|
||
Deferred rent
|
590
|
|
|
1,285
|
|
||
Deferred revenue
|
12,856
|
|
|
8,946
|
|
||
Total current liabilities
|
52,434
|
|
|
42,424
|
|
||
|
|
|
|
||||
Long-term liabilities
|
|
|
|
||||
Deferred rent
|
4,184
|
|
|
3,314
|
|
||
Deferred revenue
|
35,961
|
|
|
2,040
|
|
||
Long-term debt, net
|
113,655
|
|
|
107,280
|
|
||
Other long-term liabilities
|
598
|
|
|
496
|
|
||
Total long-term liabilities
|
154,398
|
|
|
113,130
|
|
||
Total liabilities
|
206,832
|
|
|
155,554
|
|
||
|
|
|
|
||||
Commitments and contingencies
|
|
|
|
||||
|
|
|
|
||||
Stockholders' equity (deficit)
|
|
|
|
||||
Preferred stock, $0.001 par value; 10,000,000 shares authorized, no shares issued and outstanding
|
—
|
|
|
—
|
|
||
Common stock, $0.001 par value; 280,000,000 and 220,000,000 shares authorized as of June 30, 2016 and June 30, 2015, respectively, 143,690,104 and 142,107,025 shares issued and outstanding as of June 30, 2016 and June 30, 2015, respectively
|
144
|
|
|
142
|
|
||
Additional paid-in capital
|
763,324
|
|
|
751,073
|
|
||
Accumulated other comprehensive income
|
7
|
|
|
5
|
|
||
Accumulated deficit
|
(801,407
|
)
|
|
(708,567
|
)
|
||
Total stockholders' equity (deficit)
|
(37,932
|
)
|
|
42,653
|
|
||
Total liabilities and stockholders' equity (deficit)
|
$
|
168,900
|
|
|
$
|
198,207
|
|
|
|
|
|
||||
The accompanying notes are an integral part of these financial statements.
|
|
Year Ended June 30,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
Revenue
|
|
|
|
|
|
||||||
License and milestone revenue
|
$
|
3,876
|
|
|
$
|
20,367
|
|
|
$
|
25,111
|
|
Reimbursement revenue
|
107,330
|
|
|
7,020
|
|
|
—
|
|
|||
Collaboration and other revenue
|
26,673
|
|
|
24,522
|
|
|
16,967
|
|
|||
Total revenue
|
137,879
|
|
|
51,909
|
|
|
42,078
|
|
|||
|
|
|
|
|
|
||||||
Operating expenses
|
|
|
|
|
|
||||||
Cost of partnered programs
|
23,166
|
|
|
44,392
|
|
|
45,965
|
|
|||
Research and development for proprietary programs
|
160,655
|
|
|
54,442
|
|
|
49,824
|
|
|||
General and administrative
|
36,267
|
|
|
31,433
|
|
|
21,907
|
|
|||
Total operating expenses
|
220,088
|
|
|
130,267
|
|
|
117,696
|
|
|||
Gain on the Binimetinib and Encorafenib Agreements, net
|
—
|
|
|
80,010
|
|
|
—
|
|
|||
Gain on sale of CMC, net
|
—
|
|
|
1,641
|
|
|
—
|
|
|||
Income (loss) from operations
|
(82,209
|
)
|
|
3,293
|
|
|
(75,618
|
)
|
|||
|
|
|
|
|
|
||||||
Other income (expense)
|
|
|
|
|
|
||||||
Realized gain from marketable securities, net
|
—
|
|
|
16,255
|
|
|
—
|
|
|||
Interest income
|
243
|
|
|
68
|
|
|
77
|
|
|||
Interest expense
|
(10,874
|
)
|
|
(10,247
|
)
|
|
(9,716
|
)
|
|||
Total other income (expense), net
|
(10,631
|
)
|
|
6,076
|
|
|
(9,639
|
)
|
|||
|
|
|
|
|
|
||||||
Net income (loss)
|
$
|
(92,840
|
)
|
|
$
|
9,369
|
|
|
$
|
(85,257
|
)
|
|
|
|
|
|
|
||||||
Change in unrealized gain on marketable securities
|
2
|
|
|
3
|
|
|
4
|
|
|||
|
|
|
|
|
|
||||||
Comprehensive income (loss)
|
$
|
(92,838
|
)
|
|
$
|
9,372
|
|
|
$
|
(85,253
|
)
|
|
|
|
|
|
|
||||||
Net earnings (loss) per share – basic
|
$
|
(0.65
|
)
|
|
$
|
0.07
|
|
|
$
|
(0.69
|
)
|
Net earnings (loss) per share – diluted
|
$
|
(0.65
|
)
|
|
$
|
0.07
|
|
|
$
|
(0.69
|
)
|
|
|
|
|
|
|
||||||
Weighted average shares outstanding – basic
|
142,964
|
|
|
136,679
|
|
|
123,403
|
|
|||
Weighted average shares outstanding – diluted
|
142,964
|
|
|
141,692
|
|
|
123,403
|
|
|||
|
|
|
|
|
|
||||||
The accompanying notes are an integral part of these financial statements.
|
|
|
|
|
|
|
|
|
|
Additional Paid-in Capital
|
|
Accumulated Other Comprehensive Income
|
|
Accumulated Deficit
|
|
Total
|
||||||||||||||
|
Preferred Stock
|
|
Common Stock
|
|
|
|
|
||||||||||||||||||||||
|
Shares
|
|
Amounts
|
|
Shares
|
|
Amounts
|
|
|
|
|
||||||||||||||||||
Balance as of July 1, 2013
|
—
|
|
|
$
|
—
|
|
|
116,878
|
|
|
$
|
117
|
|
|
$
|
610,655
|
|
|
$
|
(2
|
)
|
|
$
|
(632,679
|
)
|
|
$
|
(21,909
|
)
|
Shares issued for cash under employee share plans, net
|
—
|
|
|
—
|
|
|
1,132
|
|
|
1
|
|
|
3,692
|
|
|
—
|
|
|
—
|
|
|
3,693
|
|
||||||
Employee share-based compensation expense
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
4,331
|
|
|
—
|
|
|
—
|
|
|
4,331
|
|
||||||
Issuance of common stock, net of offering costs
|
—
|
|
|
—
|
|
|
13,807
|
|
|
14
|
|
|
73,434
|
|
|
—
|
|
|
—
|
|
|
73,448
|
|
||||||
Offering costs for convertible senior notes, equity portion
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(31
|
)
|
|
—
|
|
|
—
|
|
|
(31
|
)
|
||||||
Change in unrealized loss on marketable securities
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
4
|
|
|
—
|
|
|
4
|
|
||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(85,257
|
)
|
|
(85,257
|
)
|
||||||
Balance as of June 30, 2014
|
—
|
|
|
—
|
|
|
131,817
|
|
|
132
|
|
|
692,081
|
|
|
2
|
|
|
(717,936
|
)
|
|
(25,721
|
)
|
||||||
Shares issued for cash under employee share plans, net
|
—
|
|
|
—
|
|
|
1,325
|
|
|
1
|
|
|
4,397
|
|
|
—
|
|
|
—
|
|
|
4,398
|
|
||||||
Employee share-based compensation expense
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
7,513
|
|
|
—
|
|
|
—
|
|
|
7,513
|
|
||||||
Non-employee share-based compensation expense
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
547
|
|
|
—
|
|
|
—
|
|
|
547
|
|
||||||
Issuance of common stock, net of offering costs
|
—
|
|
|
—
|
|
|
8,965
|
|
|
9
|
|
|
46,535
|
|
|
—
|
|
|
—
|
|
|
46,544
|
|
||||||
Change in unrealized gain on marketable securities
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
3
|
|
|
—
|
|
|
3
|
|
||||||
Net income
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
9,369
|
|
|
9,369
|
|
||||||
Balance as of June 30, 2015
|
—
|
|
|
—
|
|
|
142,107
|
|
|
142
|
|
|
751,073
|
|
|
5
|
|
|
(708,567
|
)
|
|
42,653
|
|
||||||
Shares issued for cash under employee share plans, net
|
—
|
|
|
—
|
|
|
782
|
|
|
1
|
|
|
2,031
|
|
|
—
|
|
|
—
|
|
|
2,032
|
|
||||||
Employee share-based compensation expense
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
7,283
|
|
|
—
|
|
|
—
|
|
|
7,283
|
|
||||||
Warrants exercised - cashless
|
—
|
|
|
—
|
|
|
223
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Warrants exercised for cash
|
—
|
|
|
—
|
|
|
12
|
|
|
—
|
|
|
46
|
|
|
—
|
|
|
—
|
|
|
46
|
|
||||||
Issuance of common stock, net of offering costs
|
—
|
|
|
—
|
|
|
566
|
|
|
1
|
|
|
2,891
|
|
|
—
|
|
|
—
|
|
|
2,892
|
|
||||||
Change in unrealized gain on marketable securities
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2
|
|
|
—
|
|
|
2
|
|
||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(92,840
|
)
|
|
(92,840
|
)
|
||||||
Balance as of June 30, 2016
|
—
|
|
|
$
|
—
|
|
|
143,690
|
|
|
$
|
144
|
|
|
$
|
763,324
|
|
|
$
|
7
|
|
|
$
|
(801,407
|
)
|
|
$
|
(37,932
|
)
|
|
|||||||||||||||||||||||||||||
The accompanying notes are an integral part of these financial statements.
|
|
Year Ended June 30,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
Cash flows from operating activities
|
|
|
|
|
|
||||||
Net income (loss)
|
$
|
(92,840
|
)
|
|
$
|
9,369
|
|
|
$
|
(85,257
|
)
|
Adjustments to reconcile net income (loss) to net cash used in operating activities:
|
|
|
|
|
|
||||||
Depreciation and amortization expense
|
1,529
|
|
|
3,702
|
|
|
4,506
|
|
|||
Non-cash interest expense
|
6,375
|
|
|
5,799
|
|
|
5,258
|
|
|||
Share-based compensation expense
|
7,283
|
|
|
7,809
|
|
|
4,331
|
|
|||
Extinguishment of co-development liability, net
|
—
|
|
|
(21,610
|
)
|
|
—
|
|
|||
Realized gain from marketable securities, net
|
—
|
|
|
(16,255
|
)
|
|
—
|
|
|||
Gain on sale of CMC, net
|
—
|
|
|
(1,641
|
)
|
|
—
|
|
|||
Non-cash license revenue
|
—
|
|
|
—
|
|
|
(4,500
|
)
|
|||
Changes in operating assets and liabilities:
|
|
|
|
|
|
||||||
Accounts receivable
|
(32,995
|
)
|
|
(7,592
|
)
|
|
4,166
|
|
|||
Prepaid expenses and other assets
|
(4,352
|
)
|
|
(1,260
|
)
|
|
(1,961
|
)
|
|||
Accounts payable and other accrued expenses
|
3,931
|
|
|
(1,113
|
)
|
|
1,866
|
|
|||
Accrued outsourcing costs
|
1,738
|
|
|
7,362
|
|
|
4,464
|
|
|||
Accrued compensation and benefits
|
1,126
|
|
|
(702
|
)
|
|
(1,272
|
)
|
|||
Co-development liability
|
—
|
|
|
12,169
|
|
|
5,165
|
|
|||
Deferred rent
|
175
|
|
|
(3,236
|
)
|
|
(3,645
|
)
|
|||
Deferred revenue
|
37,831
|
|
|
1,584
|
|
|
(4,807
|
)
|
|||
Other long-term liabilities
|
109
|
|
|
(178
|
)
|
|
4
|
|
|||
Net cash used in operating activities
|
(70,090
|
)
|
|
(5,793
|
)
|
|
(71,682
|
)
|
|||
|
|
|
|
|
|
||||||
Cash flows from investing activities
|
|
|
|
|
|
||||||
Purchases of property and equipment
|
(3,159
|
)
|
|
(2,507
|
)
|
|
(2,614
|
)
|
|||
Proceeds from sale of CMC
|
—
|
|
|
3,750
|
|
|
—
|
|
|||
Purchases of marketable securities
|
(139,150
|
)
|
|
(202,908
|
)
|
|
(95,602
|
)
|
|||
Proceeds from sales and maturities of marketable securities
|
208,336
|
|
|
143,616
|
|
|
100,698
|
|
|||
Net cash provided by (used in) investing activities
|
66,027
|
|
|
(58,049
|
)
|
|
2,482
|
|
|||
|
|
|
|
|
|
||||||
Cash flows from financing activities
|
|
|
|
|
|
||||||
Proceeds from the issuance of common stock
|
2,992
|
|
|
47,500
|
|
|
75,000
|
|
|||
Proceeds from employee stock purchases and options exercised
|
2,032
|
|
|
4,398
|
|
|
3,693
|
|
|||
Warrants exercised for cash
|
46
|
|
|
—
|
|
|
—
|
|
|||
Payment of debt issuance costs
|
—
|
|
|
—
|
|
|
(86
|
)
|
|||
Payment of stock offering costs
|
(100
|
)
|
|
(956
|
)
|
|
(1,552
|
)
|
|||
Net cash provided by financing activities
|
4,970
|
|
|
50,942
|
|
|
77,055
|
|
|||
|
|
|
|
|
|
||||||
Net increase (decrease) in cash and cash equivalents
|
907
|
|
|
(12,900
|
)
|
|
7,855
|
|
|||
Cash and cash equivalents at beginning of period
|
55,691
|
|
|
68,591
|
|
|
60,736
|
|
|||
Cash and cash equivalents at end of period
|
$
|
56,598
|
|
|
$
|
55,691
|
|
|
$
|
68,591
|
|
|
|
|
|
|
|
||||||
Supplemental disclosure of cash flow information
|
|
|
|
|
|
||||||
Cash paid for interest
|
$
|
4,466
|
|
|
$
|
4,450
|
|
|
$
|
4,349
|
|
Change in unrealized gain on marketable securities
|
$
|
2
|
|
|
$
|
3
|
|
|
$
|
4
|
|
|
|
|
|
|
|
•
|
Level 1: Observable inputs such as unadjusted quoted prices in active markets for identical instruments.
|
•
|
Level 2: Quoted prices for similar instruments that are directly or indirectly observable in the marketplace.
|
•
|
Level 3: Significant unobservable inputs which are supported by little or no market activity and that are financial instruments whose values are determined using pricing models, discounted cash flow methodologies, or similar techniques, as well as instruments for which the determination of fair value requires significant judgment or estimation.
|
Furniture and fixtures
|
7 years
|
Equipment
|
5 years
|
Computer hardware and software
|
3 years
|
|
Year Ended June 30,
|
|||||||
|
2016
|
|
2015
|
|
2014
|
|||
|
|
|
|
|
|
|||
Novartis
|
80.5
|
%
|
|
15.8
|
%
|
|
28.6
|
%
|
Loxo
|
9.2
|
|
|
17.8
|
|
|
23.1
|
|
Cascadian Therapeutics (previously known as Oncothyreon Inc.)
|
0.1
|
|
|
42.3
|
|
|
8.2
|
|
AstraZeneca
|
0.1
|
|
|
0.1
|
|
|
12.1
|
|
|
89.9
|
%
|
|
76.0
|
%
|
|
72.0
|
%
|
|
Year Ended June 30,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
|
|
|
|
|
|
||||||
North America
|
$
|
22,474
|
|
|
$
|
43,386
|
|
|
$
|
24,757
|
|
Europe
|
114,806
|
|
|
8,293
|
|
|
17,153
|
|
|||
Asia Pacific
|
599
|
|
|
230
|
|
|
168
|
|
|||
|
$
|
137,879
|
|
|
$
|
51,909
|
|
|
$
|
42,078
|
|
|
June 30, 2016
|
||||||||||||||
|
|
|
Gross
|
|
Gross
|
|
|
||||||||
|
Amortized
|
|
Unrealized
|
|
Unrealized
|
|
Fair
|
||||||||
|
Cost
|
|
Gains
|
|
Losses
|
|
Value
|
||||||||
Short-term available-for-sale securities:
|
|
|
|
|
|
|
|
||||||||
U.S. treasury securities
|
$
|
53,113
|
|
|
$
|
8
|
|
|
$
|
(1
|
)
|
|
$
|
53,120
|
|
Mutual fund securities
|
224
|
|
|
—
|
|
|
—
|
|
|
224
|
|
||||
|
53,337
|
|
|
8
|
|
|
(1
|
)
|
|
53,344
|
|
||||
Long-term available-for-sale securities:
|
|
|
|
|
|
|
|
||||||||
Mutual fund securities
|
596
|
|
|
—
|
|
|
—
|
|
|
596
|
|
||||
|
596
|
|
|
—
|
|
|
—
|
|
|
596
|
|
||||
Total
|
$
|
53,933
|
|
|
$
|
8
|
|
|
$
|
(1
|
)
|
|
$
|
53,940
|
|
|
June 30, 2015
|
||||||||||||||
|
|
|
Gross
|
|
Gross
|
|
|
||||||||
|
Amortized
|
|
Unrealized
|
|
Unrealized
|
|
Fair
|
||||||||
|
Cost
|
|
Gains
|
|
Losses
|
|
Value
|
||||||||
Short-term available-for-sale securities:
|
|
|
|
|
|
|
|
||||||||
U.S. treasury securities
|
$
|
122,199
|
|
|
$
|
8
|
|
|
$
|
(3
|
)
|
|
$
|
122,204
|
|
Mutual fund securities
|
431
|
|
|
—
|
|
|
—
|
|
|
431
|
|
||||
|
122,630
|
|
|
8
|
|
|
(3
|
)
|
|
122,635
|
|
||||
Long-term available-for-sale securities:
|
|
|
|
|
|
|
|
||||||||
Mutual fund securities
|
496
|
|
|
—
|
|
|
—
|
|
|
496
|
|
||||
|
496
|
|
|
—
|
|
|
—
|
|
|
496
|
|
||||
Total
|
$
|
123,126
|
|
|
$
|
8
|
|
|
$
|
(3
|
)
|
|
$
|
123,131
|
|
|
June 30,
|
||||||
|
2016
|
|
2015
|
||||
|
|
|
|
||||
Quoted prices in active markets for identical assets (Level 1)
|
$
|
53,940
|
|
|
$
|
123,131
|
|
Quoted prices for similar assets observable in the marketplace (Level 2)
|
—
|
|
|
—
|
|
||
Significant unobservable inputs (Level 3)
|
—
|
|
|
—
|
|
||
Total
|
$
|
53,940
|
|
|
$
|
123,131
|
|
|
|
Year Ended
|
||
|
|
June 30, 2015
|
||
Balance, beginning of period
|
|
$
|
—
|
|
Transfer into Level 3 due to restriction period on trading
|
|
4,500
|
|
|
Change in unrealized gains and losses included in comprehensive income (loss)
|
|
13,205
|
|
|
Transfer out of Level 3 due to elimination of trading restrictions
|
|
(17,705
|
)
|
|
Balance, end of period
|
|
$
|
—
|
|
|
Amortized
|
|
Fair
|
||||
|
Cost
|
|
Value
|
||||
|
|
|
|
||||
Due in one year or less
|
$
|
53,113
|
|
|
$
|
53,120
|
|
Due in one year to three years
|
—
|
|
|
—
|
|
||
Total
|
$
|
53,113
|
|
|
$
|
53,120
|
|
Non-contingent cash consideration received
|
|
$
|
3,750
|
|
Fixed assets or related lease costs sold or written off
|
|
(1,818
|
)
|
|
Fair value of stock options issued to retained CMC employees
|
|
(278
|
)
|
|
Other extinguished employee liabilities
|
|
276
|
|
|
Estimated transaction costs
|
|
(342
|
)
|
|
Deferred revenue associated with undelivered elements
|
|
144
|
|
|
Other
|
|
(91
|
)
|
|
Gain on sale of CMC, net
|
|
$
|
1,641
|
|
|
|
Year Ended June 30,
|
||||||||||
|
|
2016
|
|
2015
|
|
2014
|
||||||
|
|
|
|
|
|
|
||||||
Novartis (1)
|
|
$
|
110,930
|
|
|
$
|
8,220
|
|
|
$
|
12,053
|
|
Loxo Oncology
|
|
12,635
|
|
|
9,223
|
|
|
9,708
|
|
|||
Pierre Fabre
|
|
3,724
|
|
|
—
|
|
|
—
|
|
|||
Mirati
|
|
3,557
|
|
|
1,200
|
|
|
—
|
|
|||
Celgene
|
|
3,126
|
|
|
4,132
|
|
|
3,742
|
|
|||
Biogen Idec
|
|
2,816
|
|
|
4,593
|
|
|
282
|
|
|||
Asahi Kasei
|
|
600
|
|
|
—
|
|
|
—
|
|
|||
Cascadian Therapeutics (previously known as Oncothyreon Inc.)
|
|
183
|
|
|
21,955
|
|
|
3,464
|
|
|||
AstraZeneca, PLC (2)
|
|
152
|
|
|
73
|
|
|
5,104
|
|
|||
Genentech
|
|
24
|
|
|
367
|
|
|
3,568
|
|
|||
Other partners
|
|
132
|
|
|
2,146
|
|
|
4,157
|
|
|||
Total revenue
|
|
$
|
137,879
|
|
|
$
|
51,909
|
|
|
$
|
42,078
|
|
|
|
|
|
|
|
|
(2)
|
2014 includes a
$5.0 million
milestone from AstraZeneca for the start of a Phase 3 clinical study.
|
|
June 30,
|
||||||
|
2016
|
|
2015
|
||||
|
|
|
|
||||
Furniture and fixtures
|
$
|
2,647
|
|
|
$
|
2,647
|
|
Equipment
|
26,120
|
|
|
26,120
|
|
||
Computer hardware and software
|
15,953
|
|
|
14,336
|
|
||
Leasehold improvements
|
15,577
|
|
|
15,335
|
|
||
Property and equipment, gross
|
60,297
|
|
|
58,438
|
|
||
Less: accumulated depreciation and amortization
|
(53,617
|
)
|
|
(53,388
|
)
|
||
Property and equipment, net
|
$
|
6,680
|
|
|
$
|
5,050
|
|
|
June 30,
|
||||||
|
2016
|
|
2015
|
||||
|
|
|
|
||||
Comerica term loan
|
$
|
14,550
|
|
|
$
|
14,550
|
|
Convertible senior notes
|
132,250
|
|
|
132,250
|
|
||
Long-term debt, gross
|
146,800
|
|
|
146,800
|
|
||
Less: Unamortized debt discount and fees
|
(33,145
|
)
|
|
(39,520
|
)
|
||
Long-term debt, net
|
$
|
113,655
|
|
|
$
|
107,280
|
|
|
Year Ended June 30,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
Comerica Term Loan
|
|
|
|
|
|
||||||
Simple interest
|
$
|
501
|
|
|
$
|
480
|
|
|
$
|
479
|
|
Amortization of fees paid for letters of credit
|
31
|
|
|
44
|
|
|
48
|
|
|||
Total interest expense on the Comerica term loan
|
532
|
|
|
524
|
|
|
527
|
|
|||
|
|
|
|
|
|
||||||
Convertible Senior Notes
|
|
|
|
|
|
||||||
Contractual interest
|
3,967
|
|
|
3,968
|
|
|
3,979
|
|
|||
Amortization of debt discount
|
6,033
|
|
|
5,447
|
|
|
4,932
|
|
|||
Amortization of debt issuance costs
|
342
|
|
|
308
|
|
|
278
|
|
|||
Total interest expense on the convertible senior notes
|
10,342
|
|
|
9,723
|
|
|
9,189
|
|
|||
Total interest expense
|
$
|
10,874
|
|
|
$
|
10,247
|
|
|
$
|
9,716
|
|
|
Principal Due
|
||
|
|
||
2017
|
$
|
—
|
|
2018
|
14,550
|
|
|
2019
|
—
|
|
|
2020
|
132,250
|
|
|
2021
|
—
|
|
|
Thereafter
|
—
|
|
|
|
$
|
146,800
|
|
|
|
Rental Payments
|
||
|
|
|
||
2017
|
|
$
|
3,750
|
|
2018
|
|
3,540
|
|
|
2019
|
|
3,539
|
|
|
2020
|
|
3,581
|
|
|
2021
|
|
3,651
|
|
|
Thereafter
|
|
14,347
|
|
|
|
|
$
|
32,408
|
|
|
Year Ended June 30,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
|
|
|
|
|
|
||||||
Cash paid for rent
|
$
|
4,785
|
|
|
$
|
8,276
|
|
|
$
|
8,878
|
|
Deferred rent credits
|
(1,270
|
)
|
|
(3,236
|
)
|
|
(3,645
|
)
|
|||
Rent expense, net
|
$
|
3,515
|
|
|
$
|
5,040
|
|
|
$
|
5,233
|
|
(i)
|
25%
of our issued and outstanding shares of common stock, on a fully diluted and as-converted basis; and
|
(ii)
|
the number of outstanding shares relating to awards under the Option and Incentive Plan plus the number of shares available for future grants of awards under the Option and Incentive Plan on that date.
|
|
Year Ended June 30,
|
||||||
|
2016
|
|
2015
|
||||
|
|
|
|
||||
Total shares of common stock sold
|
566
|
|
|
8,965
|
|
||
Average price per share
|
$
|
5.28
|
|
|
$
|
5.30
|
|
Gross proceeds
|
$
|
2,992
|
|
|
$
|
47,500
|
|
Commissions earned by Cantor and other costs
|
$
|
100
|
|
|
$
|
956
|
|
|
|
Year Ended June 30,
|
||||||||||
|
|
2016
|
|
2015
|
|
2014
|
||||||
Awards issued to employees
|
|
$
|
7,283
|
|
|
$
|
7,513
|
|
|
$
|
4,331
|
|
Options issued to transitioned CMC employees, net of other CMC share-based compensation amounts
|
|
—
|
|
|
251
|
|
|
—
|
|
|||
Other non-employee awards
|
|
—
|
|
|
296
|
|
|
—
|
|
|||
Total share-based compensation expense
|
|
$
|
7,283
|
|
|
$
|
8,060
|
|
|
$
|
4,331
|
|
•
|
Risk-free interest rate - We determine the risk-free interest rate by using a weighted average assumption equivalent to the expected term based on the U.S. Treasury constant maturity rate.
|
•
|
Expected term - We estimate the expected term of our options based upon historical exercises and post-vesting termination behavior.
|
•
|
Expected volatility - We estimate expected volatility using daily historical trading data of our common stock.
|
•
|
Dividend yield - We have never paid dividends and currently have no plans to do so; therefore, no dividend yield is applied.
|
|
Year Ended June 30,
|
||||
|
2016
|
|
2015
|
|
2014
|
|
|
|
|
|
|
Risk-free interest rate
|
1.30% - 1.83%
|
|
1.5% - 2.1%
|
|
1.7% - 2.1%
|
Expected option term in years
|
5.5 - 6.25
|
|
6.25
|
|
6.25
|
Expected volatility
|
55.7% - 60.1%
|
|
60.8% - 67.1%
|
|
67.8% - 68.9%
|
Dividend yield
|
0%
|
|
0%
|
|
0%
|
Weighted average grant date fair value
|
$1.95
|
|
$3.86
|
|
$2.91
|
|
Year Ended June 30,
|
||
|
|
2015
|
|
|
|
|
|
Risk-free interest rate
|
|
0.4% - 0.6%
|
|
Expected option term in years
|
|
1.25 - 2.00
|
|
Expected volatility
|
|
58.9% - 61.2%
|
|
Dividend yield
|
|
0%
|
|
Weighted average grant date fair value
|
|
$2.16
|
|
|
Number of RSUs
|
|
Weighted
Average Grant Date Fair Value |
|||
Unvested at June 30, 2015
|
678,247
|
|
|
$
|
5.35
|
|
Granted
|
329,597
|
|
|
$
|
3.31
|
|
Vested
|
(160,828
|
)
|
|
$
|
5.12
|
|
Forfeited
|
(14,916
|
)
|
|
$
|
7.30
|
|
Unvested at June 30, 2016
|
832,100
|
|
|
$
|
4.55
|
|
|
Year Ended June 30,
|
|||||||
|
2016
|
|
2015
|
|
2014
|
|||
|
|
|
|
|
|
|||
U.S. federal income tax expense at the statutory rate
|
34.0
|
%
|
|
34.0
|
%
|
|
34.0
|
%
|
Change in valuation allowance
|
(53.4
|
)
|
|
110.2
|
|
|
(37.5
|
)
|
Change in tax contingency reserve (releases)
|
(5.7
|
)
|
|
38.4
|
|
|
(0.3
|
)
|
State income taxes, net of federal taxes
|
2.1
|
|
|
11.1
|
|
|
3.1
|
|
Stock-based compensation
|
(1.1
|
)
|
|
10.5
|
|
|
(1.2
|
)
|
Available research and experimentation tax credits
|
5.0
|
|
|
(29.6
|
)
|
|
2.0
|
|
Orphan drug credit
|
19.3
|
|
|
(176.0
|
)
|
|
—
|
|
Rate change
|
—
|
|
|
1.0
|
|
|
—
|
|
Effect of other permanent differences
|
—
|
|
|
0.4
|
|
|
(0.1
|
)
|
Other
|
(0.2
|
)
|
|
—
|
|
|
—
|
|
Total
|
0.0
|
%
|
|
0.0
|
%
|
|
0.0
|
%
|
|
June 30,
|
||||||
|
2016
|
|
2015
|
||||
Deferred tax assets
|
|
|
|
||||
Accrued benefits
|
$
|
2,568
|
|
|
$
|
2,030
|
|
Inventory reserve
|
1,514
|
|
|
1,514
|
|
||
Net operating loss carryforwards
|
201,571
|
|
|
178,120
|
|
||
Capital loss carryforwards
|
—
|
|
|
61
|
|
||
Research and experimentation credit carryforwards
|
33,834
|
|
|
31,004
|
|
||
Orphan drug credit carryforwards
|
45,420
|
|
|
21,838
|
|
||
Third party agreement payment
|
8,452
|
|
|
9,070
|
|
||
Deferred revenue
|
670
|
|
|
3,818
|
|
||
Deferred rent
|
1,772
|
|
|
1,707
|
|
||
Stock compensation
|
4,499
|
|
|
3,375
|
|
||
Depreciation of property and equipment
|
4,112
|
|
|
4,519
|
|
||
Loan costs on convertible senior notes
|
278
|
|
|
371
|
|
||
Other
|
35
|
|
|
12
|
|
||
Total deferred tax assets
|
304,725
|
|
|
257,439
|
|
||
Deferred tax liabilities
|
|
|
|
||||
Discount on convertible senior notes
|
(11,639
|
)
|
|
(13,877
|
)
|
||
Unrealized gain (loss) on marketable securities
|
(3
|
)
|
|
(2
|
)
|
||
Total deferred tax liabilities
|
(11,642
|
)
|
|
(13,879
|
)
|
||
Less valuation allowance
|
(293,083
|
)
|
|
(243,560
|
)
|
||
Net deferred tax assets
|
$
|
—
|
|
|
$
|
—
|
|
|
Year Ended June 30,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
|
|
|
|
|
|
||||||
Balance at beginning of year
|
$
|
7,311
|
|
|
$
|
3,676
|
|
|
$
|
3,428
|
|
Additions based on tax positions related to the current year
|
5,071
|
|
|
3,551
|
|
|
712
|
|
|||
Additions for tax positions of prior year
|
1,323
|
|
|
559
|
|
|
—
|
|
|||
Reductions for tax positions of prior year
|
(544
|
)
|
|
(475
|
)
|
|
(464
|
)
|
|||
Balance at end of year
|
$
|
13,161
|
|
|
$
|
7,311
|
|
|
$
|
3,676
|
|
|
Year Ended June 30,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
|
|
|
|
|
|
||||||
Net earnings (loss) - basic and diluted
|
$
|
(92,840
|
)
|
|
$
|
9,369
|
|
|
$
|
(85,257
|
)
|
|
|
|
|
|
|
||||||
Weighted average shares outstanding - basic
|
142,964
|
|
|
136,679
|
|
|
123,403
|
|
|||
Warrants
|
—
|
|
|
3,560
|
|
|
—
|
|
|||
Stock options
|
—
|
|
|
1,300
|
|
|
—
|
|
|||
RSUs
|
—
|
|
|
153
|
|
|
—
|
|
|||
Weighted average shares outstanding - diluted
|
142,964
|
|
|
141,692
|
|
|
123,403
|
|
|||
|
|
|
|
|
|
||||||
Per share data:
|
|
|
|
|
|
||||||
Basic
|
$
|
(0.65
|
)
|
|
$
|
0.07
|
|
|
$
|
(0.69
|
)
|
Diluted
|
$
|
(0.65
|
)
|
|
$
|
0.07
|
|
|
$
|
(0.69
|
)
|
|
|
|
|
|
|
|
Year Ended
|
|||||||
|
June 30,
|
|||||||
|
2016
|
|
2015
|
|
2014
|
|||
Convertible senior notes
|
18,762
|
|
|
18,762
|
|
|
18,762
|
|
Warrants
|
—
|
|
|
—
|
|
|
12,000
|
|
Stock options
|
11,648
|
|
|
7,332
|
|
|
6,922
|
|
RSUs
|
832
|
|
|
275
|
|
|
—
|
|
Total anti-dilutive common stock equivalents excluded from diluted loss per share calculation
|
31,242
|
|
|
26,369
|
|
|
37,684
|
|
Fiscal Year Ended June 30, 2016
|
|
First Quarter
|
|
Second Quarter
|
|
Third Quarter
|
|
Fourth Quarter
|
||||||||
Revenue
|
|
$
|
16,197
|
|
|
$
|
35,430
|
|
|
$
|
43,047
|
|
|
$
|
43,205
|
|
Research and development for proprietary programs
|
|
$
|
20,998
|
|
|
$
|
41,351
|
|
|
$
|
48,802
|
|
|
$
|
49,504
|
|
Total operating expenses
|
|
$
|
34,568
|
|
|
$
|
56,952
|
|
|
$
|
63,055
|
|
|
$
|
65,513
|
|
Net loss
|
|
$
|
(20,987
|
)
|
|
$
|
(24,164
|
)
|
|
$
|
(22,675
|
)
|
|
$
|
(25,014
|
)
|
Net earnings (loss) per share – basic
|
|
$
|
(0.15
|
)
|
|
$
|
(0.17
|
)
|
|
$
|
(0.16
|
)
|
|
$
|
(0.17
|
)
|
Net earnings (loss) per share – diluted
|
|
$
|
(0.15
|
)
|
|
$
|
(0.17
|
)
|
|
$
|
(0.16
|
)
|
|
$
|
(0.17
|
)
|
Weighted average shares outstanding – basic
|
|
142,216
|
|
|
142,833
|
|
|
143,338
|
|
|
143,475
|
|
||||
Weighted average shares outstanding – diluted
|
|
142,216
|
|
|
142,833
|
|
|
143,338
|
|
|
143,475
|
|
Fiscal Year Ended June 30, 2015
|
|
First Quarter
|
|
Second Quarter
|
|
Third Quarter
|
|
Fourth Quarter
|
||||||||
Revenue
|
|
$
|
6,069
|
|
|
$
|
26,919
|
|
|
$
|
6,601
|
|
|
$
|
12,320
|
|
Research and development for proprietary programs
|
|
$
|
12,190
|
|
|
$
|
11,817
|
|
|
$
|
11,817
|
|
|
$
|
18,618
|
|
Total operating expenses
|
|
$
|
31,166
|
|
|
$
|
32,993
|
|
|
$
|
32,144
|
|
|
$
|
33,964
|
|
Net income (loss)
|
|
$
|
(27,593
|
)
|
|
$
|
(8,611
|
)
|
|
$
|
58,307
|
|
|
$
|
(12,734
|
)
|
Net earnings (loss) per share – basic
|
|
$
|
(0.21
|
)
|
|
$
|
(0.06
|
)
|
|
$
|
0.42
|
|
|
$
|
(0.09
|
)
|
Net earnings (loss) per share – diluted
|
|
$
|
(0.21
|
)
|
|
$
|
(0.06
|
)
|
|
$
|
0.37
|
|
|
$
|
(0.09
|
)
|
Weighted average shares outstanding – basic
|
|
131,826
|
|
|
133,815
|
|
|
139,769
|
|
|
141,393
|
|
||||
Weighted average shares outstanding – diluted
|
|
131,826
|
|
|
133,815
|
|
|
166,265
|
|
|
141,393
|
|
|
|
|
|
Incorporated by Reference
|
||||
Exhibit Number
|
|
Description of Exhibit
|
|
Form
|
|
File No.
|
|
Date Filed
|
3.1
|
|
Amended and Restated Certificate of Incorporation of Array BioPharma Inc., as amended
|
|
|
|
Filed herewith
|
|
|
3.2
|
|
Bylaws of Array Biopharma Inc., as amended and restated on October 30, 2008
|
|
8-K
|
|
001-16633
|
|
11/4/2008
|
4.1
|
|
Specimen certificate representing the common stock
|
|
S-1/A
|
|
333-45922
|
|
10/27/2000
|
4.2
|
|
Indenture dated June 10, 2013 between the registrant and Wells Fargo Bank, National Association
|
|
8-K
|
|
001-16633
|
|
6/10/2013
|
4.3
|
|
First Supplemental Indenture dated June 10, 2013 between the registrant and Wells Fargo Bank, National Association (including the form of global note for the 3.00% Convertible Senior Notes due 2020)
|
|
8-K
|
|
001-16633
|
|
6/10/2013
|
10.1
|
|
Amended and Restated Investor Rights Agreement between registrant and the parties whose signatures appear on the signature pages thereto, dated November 16, 1999
|
|
S-1
|
|
333-45922
|
|
9/15/2000
|
10.2
|
|
Amendment No. 1 to Amended and Restated Investor Rights Agreement between registrant and the parties whose signatures appear on the signature pages thereto, dated August 31, 2000
|
|
S-1
|
|
333-45922
|
|
9/15/2000
|
10.3
|
|
Amended and Restated Array BioPharma Inc. Stock Option and Incentive Plan, as amended*
|
|
DEF-14A
|
|
001-16633
|
|
9/18/2015
|
10.4
|
|
Amendment to Amended and Restated Array BioPharma Inc. Stock Option and Incentive Plan, as amended*
|
|
10-K
|
|
001-16633
|
|
8/16/2012
|
10.5
|
|
Form of Incentive Stock Option Agreement, as amended*
|
|
10-K
|
|
001-16633
|
|
9/1/2006
|
10.6
|
|
Form of Nonqualified Stock Option Agreement, as amended*
|
|
10-K
|
|
001-16633
|
|
9/1/2006
|
10.7
|
|
Form of Restricted Stock Unit Agreement*
|
|
8-K
|
|
001-16633
|
|
8/20/2014
|
10.8
|
|
Amended and Restated Array BioPharma Inc. Employee Stock Purchase Plan*
|
|
DEF-14A
|
|
001-16633
|
|
9/12/2014
|
10.9
|
|
Employment Agreement, dated April 26, 2012, between registrant and Ron Squarer*
|
|
8-K
|
|
001-16633
|
|
5/1/2012
|
10.10
|
|
Noncompete Agreement, dated April 26, 2012, between registrant and Ron Squarer*
|
|
8-K
|
|
001-16633
|
|
5/1/2012
|
10.11
|
|
Confidentiality and Inventions Agreement, dated April 26, 2012, between registrant and Ron Squarer*
|
|
8-K
|
|
001-16633
|
|
5/1/2012
|
10.12
|
|
Employment Agreement, effective as of March 4, 2002, between registrant and John Moore*
|
|
10-K
|
|
001-16633
|
|
9/30/2002
|
10.13
|
|
Employment Agreement, dated May 13, 2014, between registrant and Nicholas A. Saccomano, Ph.D.*
|
|
10-K
|
|
001-16633
|
|
8/15/2014
|
10.14
|
|
Employment Agreement, dated August 29, 2014, between registrant and Victor Sandor, M.D.*
|
|
8-K
|
|
001-16633
|
|
9/12/14
|
10.15
|
|
Noncompete Agreement, dated August 29, 2014, between registrant and Victor Sandor, M.D.*
|
|
8-K
|
|
001-16633
|
|
9/12/14
|
10.16
|
|
Confidentiality and Inventions Agreement, dated August 29, 2014, between registrant and Victor Sandor, M.D.*
|
|
8-K
|
|
001-16633
|
|
9/12/14
|
10.17
|
|
Employment Agreement, dated September 11, 2014, between registrant and Andrew Robbins*
|
|
8-K
|
|
001-16633
|
|
9/12/14
|
10.18
|
|
Amended and Restated Deferred Compensation Plan of Array BioPharma Inc., dated December 20, 2004*
|
|
8-K
|
|
001-16633
|
|
12/21/2004
|
10.19
|
|
First Amendment to the Amended and Restated Deferred Compensation Plan of Array BioPharma Inc.*
|
|
10-Q
|
|
001-16633
|
|
2/6/2006
|
10.20
|
|
Research Services Agreement between registrant and Eli Lilly and Company, dated March 22, 2000, as amended**
|
|
S-1
|
|
333-45922
|
|
9/15/2000
|
10.21
|
|
Research Agreement between registrant and Amgen Inc., dated as of November 1, 2001**
|
|
8-K/A
|
|
001-16633
|
|
2/6/2002
|
10.22
|
|
Lead Generation Collaboration Agreement between registrant and Takeda Chemical Industries, Ltd., dated July 18, 2001**
|
|
10-Q
|
|
001-16633
|
|
11/14/2001
|
10.23
|
|
Collaboration and License Agreement between registrant and AstraZeneca AB, dated December 18, 2003**
|
|
10-Q
|
|
001-16633
|
|
2/2/2004
|
|
|
|
|
Incorporated by Reference
|
||||
Exhibit Number
|
|
Description of Exhibit
|
|
Form
|
|
File No.
|
|
Date Filed
|
10.24
|
|
Drug Discovery Collaboration Agreement between registrant and Genentech, Inc., dated December 22, 2003**
|
|
10-Q
|
|
001-16633
|
|
2/2/2004
|
10.25
|
|
Second Amendment, dated October 1, 2005, to the Drug Discovery Collaboration Agreement between registrant and Genentech, Inc.**
|
|
10-Q
|
|
001-16633
|
|
2/6/2006
|
10.26
|
|
Letter Agreement dated, July 30, 2009, between the registrant and Genentech, Inc.**
|
|
10-Q
|
|
001-16633
|
|
11/2/2009
|
10.27
|
|
Sixth Amendment to Drug Discovery Collaboration Agreement, dated as of September 30, 2010, between the registrant and Genentech, Inc.
|
|
10-Q
|
|
001-16633
|
|
11/9/2010
|
10.28
|
|
Seventh Amendment to Drug Discovery Collaboration Agreement, dated as of February 10, 2015, between the registrant and Genentech, Inc.**
|
|
10-Q
|
|
001-16633
|
|
5/7/2015
|
10.29
|
|
License Agreement, dated August 5, 2011, between the registrant and Genentech, Inc.**
|
|
10-Q
|
|
001-16633
|
|
11/2/2011
|
10.30
|
|
Drug Discovery Collaboration Agreement between registrant and InterMune, Inc., dated September 13, 2002, along with Amendment No. 1 dated May 8, 2003, Amendment No. 2 dated January 7, 2004, Amendment No. 3 dated September 10, 2004, Amendment No. 4 dated December 7, 2004, Amendment No. 4A dated March 10, 2005 and Amendment No. 5 dated June 30, 2005**
|
|
10-K
|
|
001-16633
|
|
9/13/2005
|
10.31
|
|
Amendment No. 6, dated February 3, 2006, to the Drug Discovery Collaboration Agreement between registrant and InterMune, Inc., dated September 13, 2002**
|
|
10-K
|
|
001-16633
|
|
9/1/2006
|
10.32
|
|
Amendment No. 7, dated June 28, 2006, to the Drug Discovery Collaboration Agreement between registrant and InterMune, Inc., dated September 13, 2002**
|
|
10-K
|
|
001-16633
|
|
9/1/2006
|
10.33
|
|
Exercise of Option to Extend Funding of Research FTEs, dated August 31, 2006, to the Drug Discovery Collaboration Agreement between registrant and InterMune, Inc., dated September 13, 2002
|
|
10-Q
|
|
001-16633
|
|
11/6/2006
|
10.34
|
|
Drug Discovery Agreement between registrant and Ono Pharmaceutical Co., Ltd., dated November 1, 2005**
|
|
10-Q
|
|
001-16633
|
|
2/6/2006
|
10.35
|
|
Loan and Security agreement, dated June 28, 2005, by and between registrant and Comerica Bank
|
|
10-K
|
|
001-16633
|
|
9/13/2005
|
10.36
|
|
First Amendment to Loan and Security agreement, dated December 19, 2005, by and between registrant and Comerica Bank
|
|
10-Q
|
|
001-16633
|
|
2/6/2006
|
10.37
|
|
Second Amendment to Loan and Security Agreement, dated July 7, 2006, between the registrant and Comerica Bank
|
|
10-Q
|
|
001-16633
|
|
11/6/2006
|
10.38
|
|
Third Amendment to Loan and Security Agreement, dated June 12, 2008, between the registrant and Comerica Bank
|
|
10-K
|
|
001-16633
|
|
8/12/2010
|
10.39
|
|
Fourth Amendment to Loan and Security Agreement, dated March 11, 2009, between the registrant and Comerica Bank
|
|
10-K
|
|
001-16633
|
|
8/12/2010
|
10.40
|
|
Fifth Amendment to Loan and Security Agreement, dated September 30, 2009, between the registrant and Comerica Bank
|
|
8-K
|
|
001-16633
|
|
10/5/2009
|
10.41
|
|
Sixth Amendment to Loan and Security Agreement, dated March 31, 2010, between the registrant and Comerica Bank
|
|
8-K
|
|
001-16633
|
|
4/6/2010
|
10.42
|
|
Seventh Amendment to Loan and Security Agreement, dated June 11, 2011, between the registrant and Comerica Bank
|
|
10-K
|
|
001-16633
|
|
8/12/2011
|
10.43
|
|
Eighth Amendment to Loan and Security Agreement, dated December 28, 2012, between the registrant and Comerica Bank
|
|
10-Q
|
|
001-16633
|
|
2/6/2013
|
10.44
|
|
Ninth Amendment to Loan and Security Agreement dated June 4, 2013, by and between the registrant and Comerica Bank
|
|
8-K
|
|
001-16633
|
|
6/10/2013
|
10.45
|
|
Tenth Amendment to Loan and Security Agreement, dated December 31, 2013, between the registrant and Comerica Bank
|
|
10-Q
|
|
001-16633
|
|
2/5/14
|
10.46
|
|
Eleventh Amendment to Loan and Security Agreement, dated August 3, 2015, between the registrant and Comerica Bank
|
|
10-K
|
|
001-16633
|
|
8/21/2015
|
10.47
|
|
Twelve Amendment to Loan and Security Agreement, dated November 4, 2015, between the registrant and Comerica Bank
|
|
10-Q
|
|
001-16633
|
|
11/5/2015
|
10.48
|
|
Facilities Lease and Assignment, dated July 7, 2006, between the registrant and BMR-3200 Walnut Street LLC
|
|
10-Q
|
|
001-16633
|
|
11/6/2006
|
10.49
|
|
Description of Performance Bonus Program*
|
|
8-K
|
|
001-16633
|
|
8/3/2016
|
|
|
|
|
Incorporated by Reference
|
||||
Exhibit Number
|
|
Description of Exhibit
|
|
Form
|
|
File No.
|
|
Date Filed
|
10.50
|
|
Collaboration and License Agreement, dated July 12, 2011, between the registrant and ASLAN Pharmaceuticals**
|
|
10-Q
|
|
001-16633
|
|
11/2/2011
|
10.51
|
|
Sales Agreement, dated March 27, 2013, by and between registrant and Cantor Fitzgerald & Co.
|
|
8-K
|
|
001-16633
|
|
3/27/2013
|
10.52
|
|
Amendment No. 1 to Sales Agreement, dated August 15, 2014, by and between registrant and Cantor Fitzgerald & Co.
|
|
POS-AM
|
|
333-189048
|
|
8/18/2014
|
10.53
|
|
Amendment No. 2 to Sales Agreement, dated August 3, 2015, by and between registrant and Cantor Fitzgerald & Co.
|
|
S-3ASR
|
|
333-206525
|
|
8/21/2016
|
10.54
|
|
Amendment No. 3 to Sales Agreement, dated November 4, 2015, by and between registrant and Cantor Fitzgerald & Co.
|
|
10-Q
|
|
001-16633
|
|
11/5/2015
|
10.55
|
|
Drug Discovery and Collaboration Agreement, dated July 3, 2013, between registrant and Loxo Oncology, Inc.**
|
|
10-K
|
|
001-16633
|
|
8/12/2013
|
10.56
|
|
Amendment No. 1 to Drug Discovery Collaboration Agreement, dated November 26, 2013, by and between registrant and Loxo Oncology, Inc.**
|
|
10-K
|
|
001-16633
|
|
8/15/2014
|
10.57
|
|
Amendment No. 2 to Drug Discovery Collaboration Agreement, dated April 10, 2014, by and between registrant and Loxo Oncology, Inc.**
|
|
10-K
|
|
001-16633
|
|
8/15/2014
|
10.58
|
|
Amendment No. 3 to Drug Discovery Collaboration Agreement, dated October 13, 2014, between registrant and Loxo Oncology, Inc.**
|
|
10-Q
|
|
001-16633
|
|
2/4/2015
|
10.59
|
|
Amendment No. 4 to Drug Discovery Collaboration Agreement, dated March 31, 2015, by and between registrant and Loxo Oncology, Inc.***
|
|
10-K
|
|
001-16633
|
|
8/21/2015
|
10.60
|
|
Drug Discovery and Development Option and License Agreement, dated July 17, 2013, between the registrant and Celgene Corporation and Celgene Alpine Investment Co., LLC**
|
|
10-Q
|
|
001-16633
|
|
11/1/2013
|
10.61
|
|
License Agreement, dated December 11, 2014, between registrant and Oncothyreon, Inc.**
|
|
10-Q
|
|
001-16633
|
|
2/4/2015
|
10.62
|
|
Termination and Asset Transfer Agreement, dated November 26, 2014, between registrant and Novartis Pharmaceutical International Ltd. and Novartis Pharma AG**
|
|
10-Q
|
|
001-16633
|
|
2/4/2015
|
10.63
|
|
First Amendment to Termination and Asset Transfer Agreement, dated January 19, 2015, between registrant, Novartis Pharma AG and Novartis Pharmaceutical International Ltd.**
|
|
10-Q
|
|
001-16633
|
|
5/7/2015
|
10.64
|
|
LGX818 Asset Transfer Agreement, dated January 19, 2015, between registrant and Novartis Pharma AG**
|
|
10-Q
|
|
001-16633
|
|
5/7/2015
|
10.65
|
|
Transition Agreement, dated March 2, 2015, between the registrant and Novartis Pharma AG (binimetinib)**
|
|
10-Q
|
|
001-16633
|
|
5/7/2015
|
10.66
|
|
Transition Agreement, dated March 2, 2015, between the registrant and Novartis Pharma AG (encorafenib)**
|
|
10-Q
|
|
001-16633
|
|
5/7/2015
|
10.67
|
|
Asset Purchase Agreement, dated June 1, 2015, by and between registrant and Accuratus Lab Services, Inc.**
|
|
10-K
|
|
001-16633
|
|
8/21/2015
|
10.68
|
|
First Amendment to and Partial Termination of Lease, dated June 1, 2015, between the registrant and BMR-3200 Walnut Street LLC
|
|
10-K
|
|
001-16633
|
|
8/21/2015
|
10.69
|
|
Amended and Restated Development and Commercialization Agreement, dated December 2, 2015, between the registrant and Pierre Fabre Medicament SAS**
|
|
10-Q/A
|
|
001-16633
|
|
6/8/2016
|
10.70
|
|
Thirteenth Amendment to Loan and Security Agreement, dated June 29, 2016, between the registrant and Comerica Bank
|
|
|
|
Filed herewith
|
|
|
10.71
|
|
Employment Agreement, dated July 28, 2016, between registrant and Jason Haddock*
|
|
|
|
Filed herewith
|
|
|
10.72
|
|
Noncompete Agreement, dated July 28, 2016, between registrant and Jason Haddock*
|
|
|
|
Filed herewith
|
|
|
10.73
|
|
Confidentiality and Inventions Agreement, dated July 28, 2016, between registrant and Jason Haddock*
|
|
|
|
Filed herewith
|
|
|
23.1
|
|
Consent of KPMG LLP, Independent Registered Public Accounting Firm
|
|
|
|
Filed herewith
|
|
|
31.1
|
|
Certification of Chief Executive Officer pursuant to Rule 13a-14(a) and 15d-14(a) of the Securities Exchange Act of 1934, as amended
|
|
|
|
Filed herewith
|
|
|
|
|
|
|
Incorporated by Reference
|
||||
Exhibit Number
|
|
Description of Exhibit
|
|
Form
|
|
File No.
|
|
Date Filed
|
31.2
|
|
Certification of Chief Financial Officer pursuant to Rule 13a-14(a) and 15d-14(a) of the Securities Exchange Act of 1934, as amended
|
|
|
|
Filed herewith
|
|
|
32.1
|
|
Certifications of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
|
|
|
Furnished
|
|
|
101.INS
|
|
XBRL Instance Document
|
|
|
|
Filed herewith
|
|
|
101.SCH
|
|
XBRL Taxonomy Extension Schema Document
|
|
|
|
Filed herewith
|
|
|
101.CAL
|
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
|
|
|
Filed herewith
|
|
|
101.LAB
|
|
XBRL Taxonomy Extension Label Linkbase Document
|
|
|
|
Filed herewith
|
|
|
101.PRE
|
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
|
|
|
Filed herewith
|
|
|
101.DEF
|
|
XBRL Taxonomy Extension Definition Linkbase Document
|
|
|
|
Filed herewith
|
|
|
|
|
|
|
|
|
|
1.
|
The name of the corporation is Array BioPharma Inc.
|
FIRST:
|
The name of the corporation is Array BioPharma Inc. (the “
Corporation
”). The Corporation was originally incorporated on February 6, 1998 pursuant to the DGCL. An Amended and Restated Certificate of Incorporation of the Corporation was filed with the Secretary of State of the State of Delaware on or about November 21, 2000 (the “
Certificate of Incorporation
”). A Certificate of Correction to the Certificate of Incorporation was filed with the Secretary of State of the State of Delaware on or about November 19, 2004.
|
SECOND:
|
That the board of directors of the Corporation duly adopted resolutions approving the following amendment to the Certificate of Incorporation (the “
Amendment
”) in accordance with the provisions of Section 242 of the DGCL, declaring such Amendment to be advisable and calling for the approval of the stockholders of the Corporation to such Amendment.
|
THIRD:
|
The Amendment was duly adopted and approved in accordance with the provisions of Section 211 of the DGCL by the required vote of the stockholders of the Corporation at the Annual Meeting of the stockholders of the Corporation.
|
FOURTH:
|
That the Corporation’s Certificate of Incorporation is hereby amended as provided herein. Section 4.1 shall be deleted in its entirety and replaced with the following:
|
FIFTH:
|
Except as expressly amended by this Amendment, the provisions of the Certificate of Incorporation shall remain in full force and effect.
|
1.
|
The name of the corporation (hereinafter called the “corporation”) is:
|
/s/ R. Michael Carruthers
Name: R. Michael Carruthers
Title: Chief Financial Officer
|
|
|
Number of shares of Series B Preferred Stock owned prior to Conversion: ________
|
|
Number of shares of Series B Preferred Stock to be Converted: _________________
|
|
Number of shares of Common Stock to be Issued: ___________________________
|
|
Address for delivery of physical certificates: ______________________
or
for DWAC Delivery:
DWAC Instructions:
Broker no: _________
Account no: ___________
|
|
|
[HOLDER]
By:___________________________________
Name:
Title:
Date:
|
|
By:___________________________________
Name:
Title:
Date:
|
FIRST:
|
The name of the corporation is Array BioPharma Inc. (the “
Corporation
”). The Corporation was originally incorporated on February 6, 1998 pursuant to the DGCL. An Amended and Restated Certificate of Incorporation of the Corporation was filed with the Secretary of State of the State of Delaware on or about November 21, 2000 (the “
Certificate of Incorporation
”). A Certificate of Correction to the Certificate of Incorporation was filed with the Secretary of State of the State of Delaware on or about November 19, 2004.
|
SECOND:
|
That the board of directors of the Corporation duly adopted resolutions approving the following amendment to the Certificate of Incorporation (the “
Amendment
”) in accordance with the provisions of Section 242 of the DGCL, declaring such Amendment to be advisable and calling for the approval of the stockholders of the Corporation to such Amendment.
|
THIRD:
|
The Amendment was duly adopted and approved in accordance with the provisions of Section 211 of the DGCL by the required vote of the stockholders of the Corporation at the Annual Meeting of the stockholders of the Corporation.
|
FOURTH:
|
That the Corporation’s Certificate of Incorporation is hereby amended as provided herein. Section 4.1 shall be deleted in its entirety and replaced with the following:
|
|
4.1 Authorized Shares.
The total number of shares of all classes of stock that the Corporation shall have the authority to issue is 230,000,000 of which 220,000,000 shall be common stock, all of one class, having a par value of $.001 per share (the “
Common Stock
”), and 10,000,000 of such shares shall be Preferred Stock, having a par value of $.001 per share (the “
Preferred Stock
”).
|
FIFTH:
|
Except as expressly amended by this Amendment, the provisions of the Certificate of Incorporation shall remain in full force and effect.
|
|
ARRAY BIOPHARMA INC.
|
|
|
/s/ R. Michael Carruthers
Name: R. Michael Carruthers
Title: Chief Financial Officer
|
|
|
|
|
|
|
|
FIRST:
|
The name of the corporation is Array BioPharma Inc. (the "Corporation"). The Corporation was originally incorporated on February 6, 1998 pursuant to the DGCL. An Amended and Restated Certificate of Incorporation of the Corporation was filed with the Secretary of State of the State of Delaware on November 21, 2000 (the "Certificate of Incorporation"). A Certificate of Correction to the Certificate of Incorporation was filed with the Secretary of State of the State of Delaware on November 22, 2004. Certificates of Amendment to the Certificate of Incorporation were filed with the Secretary of State of the State of Delaware on November 5, 2007 and October 24, 2012.
|
SECOND:
|
That the board of directors of the Corporation duly adopted resolutions approving the following amendment to the Certificate of Incorporation (the "Amendment") in accordance with the provisions of Section 242 of the DGCL, declaring such Amendment to be advisable and calling for the approval of the stockholders of the Corporation to such Amendment.
|
THIRD:
|
The Amendment was duly adopted and approved in accordance with the provisions of Section 211 of the DGCL by the required vote of the stockholders of the Corporation at the Annual Meeting of the stockholders of the Corporation.
|
FOURTH:
|
That the Corporation's Certificate of Incorporation is hereby amended as provided herein. Section 4.1 shall be deleted in its entirety and replaced with the following:
|
FIFTH:
|
Except as expressly amended by this Amendment, the provisions of the Certificate of Incorporation shall remain in full force and effect.
|
|
ARRAY BIOPHARMA INC.
|
|
|
|
|
|
By:
/s/ John Moore
|
|
|
|
Title:
General Counsel
|
|
|
|
COMERICA BANK
|
|
|
|
|
|
By:
/s/ Douglas Hollenbeck
|
|
|
|
Title:
Vice President
|
|
ARRAY BIOPHARMA INC.
|
|
|
|
|
|
|
|
|
By:
/s/ John Moore
|
|
|
|
|
|
Title:
General Counsel
|
|
|
|
|
|
COMERICA BANK
|
|
|
|
|
|
|
|
|
By:
/s/
|
|
|
|
|
|
Title:
Vice President
|
|
|
COMPANY:
|
||
|
|
|
|
|
ARRAY BIOPHARMA INC.
|
||
|
|
|
|
|
By:
|
/s/ Ron Squarer
|
|
|
Name:
|
Ron Squarer
|
|
|
Title:
|
Chief Executive Officer
|
|
|
|
|
|
|
EMPLOYEE:
|
||
|
|
|
|
|
/s/ Jason Haddock
|
||
|
Jason Haddock
|
|
|
|
|
|
|
(a)
|
Any contract for the purchase and sale of a business or the assets of a business;
|
(b)
|
Any contract for the protection of trade secrets;
|
(c)
|
Any contract provision providing for the recovery of the expense of educating and training an employee who has served an employer for a period of less than two years;
|
(d)
|
Executive and management personnel and officers and employees who constitute professional staff to executive and management personnel.
|
1.
|
I have reviewed this annual report on Form 10-K of Array BioPharma 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 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 is made known to us by others within this entity, 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
|
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 19, 2016
|
By:
|
/s/ RON SQUARER
|
|
|
|
Ron Squarer
|
|
|
|
Chief Executive Officer
|
1.
|
I have reviewed this annual report on Form 10-K of Array BioPharma 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 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 is made known to us by others within this entity, 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
|
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 19, 2016
|
By:
|
/s/ DAVID JAY HORIN
|
|
|
|
David Jay Horin
|
|
|
|
Principal Accounting Officer
|
(a)
|
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and
|
(b)
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Registrant.
|
Date:
|
August 19, 2016
|
/s/ RON SQUARER
|
|
|
Ron Squarer
|
|
|
Chief Executive Officer
|
|
|
|
|
|
|
|
|
/s/ DAVID JAY HORIN
|
|
|
David Jay Horin
|
|
|
Principal Accounting Officer
|
|
|
|