Large Accelerated Filer
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Accelerated Filer
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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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Proprietary Program
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Indication
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Clinical Status
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1.
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Filanesib
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Kinesin spindle protein, or KSP, inhibitor for MM
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Phase 2
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2.
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ARRY-797
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p38 inhibitor for Lamin A/C-related dilated cardiomyopathy, or LMNA-DCM
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Phase 2
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3.
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ARRY-502
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CRTh2 antagonist for asthma
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Phase 2
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4.
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ARRY-614
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p38/Tie2 dual inhibitor for myelodysplastic syndromes, or MDS
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Phase 1
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Drug Candidate
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Indication
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Partner
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Clinical Status
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1.
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Binimetinib
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MEK inhibitor for cancer
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Novartis International Pharmaceutical Ltd.
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Phase 3
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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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3.
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ASLAN001/ARRY-543
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HER2 / EGFR inhibitor for gastric cancer
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ASLAN Pharmaceuticals Pte Ltd.
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Phase 2
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4.
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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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5.
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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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6.
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Danoprevir
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Hepatitis C virus protease inhibitor
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InterMune (danoprevir now owned by Roche Holding AG)
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Phase 2
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7.
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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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8.
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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 1b
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9.
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ARRY-380/ONT-380
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HER2 inhibitor for breast cancer
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Oncothyreon Inc.
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Phase 1b
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10.
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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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11.
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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 1
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•
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ASLAN
– We entered into a Collaboration and License Agreement with ASLAN in July 2011 to develop Array's HER2 / EGFR inhibitor, ASLAN001/ARRY-543, which is currently in a Phase 2 clinical trial in patients with gastric cancer.
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•
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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 three Phase 3 trials.
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•
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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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InterMune (program acquired by Roche)
– We entered into a Drug Discovery Collaboration Agreement with InterMune in 2002, which resulted in the joint discovery of danoprevir, a novel small molecule inhibitor of the Hepatitis C Virus NS3/4A protease. Roche Holding AG acquired danoprevir from InterMune in 2010. Danoprevir is currently in Phase 2 clinical trials.
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•
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Novartis
– We entered into a License Agreement with Novartis in April 2010 for the worldwide development and commercialization of our MEK inhibitor, binimetinib, and other MEK inhibitors identified in the agreement. Binimetinib is currently in numerous clinical trials, including three Phase 3 trials in patients with cancer.
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•
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Oncothyreon
– We entered into a Development and Commercialization Agreement with Oncothyreon in May 2013 to collaborate on the development and commercialization of ARRY-380, an orally active, reversible and selective small-molecule HER2 inhibitor, for the treatment of cancer, including breast cancer. Oncothyreon is continuing development of ARRY-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 1 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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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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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 to receive research funding plus significant milestone payments and royalties.
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•
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The FACTOR trial, a planned global Phase 3 study comparing Kyprolis plus filanesib to Kyprolis alone in several hundred patients with relapsed/refractory multiple myeloma, or RRMM. The primary endpoint of the FACTOR trial will be progression-free survival, or PFS. To date, there are no successful drug combinations for Kyprolis in patients who have previously been treated with both Revlimid® (lenalidomide) and Velcade® (bortezomib).
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•
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The AfFIRM trial, a global Phase 2 study that began in May 2014 with single-agent filanesib in 160 patients with RRMM. While the trial will enroll patients regardless of AAG status, the primary endpoint is objective response rate, or ORR, in patients with low AAG levels at baseline. The AfFIRM trial is also designed to support future regulatory submissions and validation of AAG as a patient selection marker and will include important safety and pharmacological data.
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•
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The ARRAY-520-216 trial, a randomized Phase 2 trial that began in November 2013 comparing Kyprolis plus filanesib versus Kyprolis alone in 75 RRMM patients. The primary endpoint is PFS, and this trial will provide important safety and efficacy data to support the overall development plan, including data to support AAG as a patient selection marker in the combination of Kyprolis plus filanesib. In addition, published results from this trial may enhance Phase 3 enrollment.
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•
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report interim results from the ongoing Phase 1b study of filanesib in combination with Velcade and dexamethasone;
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•
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report interim results from the Phase 1b and ARRAY-520-216 studies of filanesib in combination with Kyprolis; and
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•
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initiate the Phase 3 FACTOR trial of filanesib in combination with Kyprolis in patients with RRMM.
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•
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alterations to cardiomyocyte and A/V nodal cell nuclei, which leads to apoptosis and cardiac tissue remodeling, and
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•
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sarcomere reorganization, which affects the heart’s contractile function.
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•
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The MILO trial, which Array is conducting, began in June 2013 and will evaluate the efficacy and safety of binimetinib compared to standard chemotherapy treatments in 300 patients with recurrent or persistent LGSOC following at least one prior platinum-based chemotherapy regimen and no more than three lines of prior chemotherapy regimens. The primary endpoint is PFS, and the key secondary endpoint is overall survival. The projected regulatory filing for the MILO study is estimated to be in 2016.
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•
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The NEMO trial, which Novartis is conducting, began in July 2013 and will evaluate the efficacy and safety of binimetinib compared to dacarbazine in 393 patients with advanced (Stage IIIC) unresectable or metastatic (Stage IV) NRAS-mutant melanoma. The primary endpoint is PFS, and the key secondary endpoint is overall survival.
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•
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The COLUMBUS trial, which is also being conducted by Novartis, began in September 2013 and will evaluate the efficacy and safety of the combination of Novartis BRAF inhibitor encorafenib
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•
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The SELECT-1 trial began in September 2013 and will evaluate the efficacy and safety of selumetinib in combination with docetaxel compared to placebo and docetaxel in 634 patients with locally advanced or metastatic KRAS-mutant NSCLCs. The primary endpoint is PFS, and the key secondary endpoint is overall survival. The estimated primary completion date for the SELECT-1 study is July 2016.
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•
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The ASTRA trial began in June 2013 and will evaluate the efficacy and safety of selumetinib with radioactive iodine therapy compared to placebo and radioactive iodine therapy in 304 patients with differentiated thyroid cancer. The primary endpoint is complete remission rate. The estimated primary completion date for the ASTRA study is June 2016.
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•
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The SUMIT trial began in April 2014 and will evaluate the efficacy and safety of selumetinib in combination with dacarbazine compared to placebo and dacarbazine in 152 patients with metastatic uveal melanoma. The primary endpoint is PFS.
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•
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Phase 2 trial with ipatasertib in combination with paclitaxel as front-line treatment for patients with metastatic triple-negative breast cancer.
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•
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Phase 2 trial (JAGUAR) with ipatasertib in combination with fluropyrimidine plus oxaliplatin in patients with advanced or metastatic gastric or gastroesophageal junction cancer.
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•
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Phase 1b/2 trial (A.MARTIN) with ipatasertib or GDC-0980, a PI3 kinase/mTor dual inhibitor, with abiraterone acetate versus abiraterone acetate in patients with locally advanced castration-resistant prostate cancer.
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•
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Phase 2 trial (GOG-3003) with VTX-2337 in combination with pegylated liposomal doxorubicin, or PLD, standard second-line chemotherapy for patients with recurrent or persistent ovarian cancer versus PLD alone.
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•
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Phase 2 trial (ACTIVE8) with VTX-2337 in combination with a standard of care regimen, cetuximab, platinum and 5 Fluorouracil, or 5-FU, in patients with recurrent or metastatic SCCHN.
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•
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Phase 1 trial with ARRY-380 in combination with Herceptin® (trastuzumab) in patients with brain metastases from HER2+ breast cancer (Dana Farber sponsored).
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•
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Phase 1 trial with ARRY-380 in combination with Kadcyla ® (T-DM1) in patients with HER2+ breast cancer (Oncothyreon sponsored).
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•
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Phase 1 trial with ARRY-380 in combination with Herceptin plus Xeloda ® (capecitabine) in patients with HER2+ breast cancer (Oncothyreon sponsored).
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|
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Estimated 2014
|
||||
Type of Cancer
|
|
New Cases
|
|
Deaths
|
||
|
|
|
|
|
||
Lung
|
|
224,210
|
|
|
159,260
|
|
Breast
|
|
235,030
|
|
|
40,430
|
|
Colorectal
|
|
136,830
|
|
|
50,310
|
|
Melanoma
|
|
76,100
|
|
|
9,710
|
|
Thyroid
|
|
62,980
|
|
|
1,890
|
|
Pancreas
|
|
46,420
|
|
|
39,590
|
|
Ovarian
|
|
21,980
|
|
|
14,270
|
|
Stomach
|
|
22,220
|
|
|
10,990
|
|
Myeloma
|
|
24,050
|
|
|
11,090
|
|
Eye and Orbit
|
|
2,730
|
|
|
310
|
|
Gallbladder and Other Biliary
|
|
10,650
|
|
|
3,630
|
|
|
|
863,200
|
|
|
341,480
|
|
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),
|
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).
|
•
|
The FACTOR trial, a planned global Phase 3 study comparing Kyprolis plus filanesib to Kyprolis alone in several hundred patients with RRMM. The primary endpoint of the FACTOR trial will be PFS. To date, there have been no successful drug combinations for Kyprolis in patients who have previously been treated with both Revlimid and Velcade.
|
•
|
The AfFIRM trial, a global Phase 2 study that began in May 2014 with single-agent filanesib in 160 patients with RRMM. While the trial will enroll patients regardless of AAG status, the primary endpoint is ORR in patients with low AAG levels at baseline. The AfFIRM trial is also designed to support future regulatory submissions and validation of AAG as a patient selection marker and will include important safety and pharmacological data.
|
•
|
The ARRAY-520-216 trial, a randomized Phase 2 trial that began in November 2013 comparing Kyprolis plus filanesib versus Kyprolis alone in 75 RRMM patients. The primary endpoint is PFS, and this trial will provide important safety and efficacy data to support the overall development plan, including data to support AAG as a patient selection marker in the combination of Kyprolis plus filanesib. In addition, published results from this trial may enhance Phase 3 enrollment.
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Phase
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Objective
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Estimated Duration
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Discovery
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Lead identification and target validation.
|
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2 to 4 years
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Preclinical
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Initial toxicology for preliminary identification of risks for humans; gather early pharmacokinetic data.
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1 to 2 years
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Phase 1
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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.
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1 to 2 years
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Phase 2
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Establish effectiveness of the drug and its optimal dosage; continue safety evaluation.
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2 to 4 years
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Phase 3
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Confirm efficacy, dosage regime and safety profile of the drug; submit new drug application, or NDA.
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2 to 4 years
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FDA Approval
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Approval by the FDA to sell and market the drug under approved labeling.
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8 months to 2 years
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•
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Discovery Research — Biology, Pharmacology, Toxicology, Chemistry and Translational Medicine;
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•
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Process Research, Development, Formulation and Manufacturing;
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•
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Clinical Development — Clinical Science, Clinical Operations, Drug Safety, Translational Medicine, Biostatistics and Data Management, Regulatory Affairs and Program Management; and
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•
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Information Systems.
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•
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The federal Anti-Kickback Statute prohibits, among other things, persons from knowingly and willfully offering, paying, soliciting, or receiving remuneration, directly or indirectly, in cash or in kind, to induce or reward the purchasing, leasing, ordering or arranging for the purchase, lease, or order of any health care item or service reimbursable under federal healthcare programs such as Medicare and Medicaid. This statute has been interpreted to apply to arrangements between pharmaceutical manufacturers on the one hand and prescribers, purchasers and formulary managers on the other. The Healthcare Reform Act amends the intent requirement of the federal Anti-Kickback Statute. A person or entity no longer needs to have actual knowledge of this statute
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•
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The federal False Claims Act imposes criminal and civil penalties and provides for civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or knowingly making, or causing to be made, a false record or statement material to a false or fraudulent claim to avoid, decrease, or conceal an obligation to pay money to the federal government. In addition, federal Anti-Kickback Statute violations and certain marketing practices, including off-label promotion, may also implicate the federal False Claims Act.
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•
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The federal Physician Payment Sunshine Act, being implemented as the Open Payments Program, requires pharmaceutical manufacturers to engage in extensive tracking of physician and teaching hospital payments, maintenance of a payments database, and public reporting of the payment data.
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•
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Analogous state laws and regulations, such as state anti-kickback and false claims laws, apply to sales or marketing arrangements and activities, including the provision of gifts, meals, or other items to certain health care providers, and claims involving healthcare items or services reimbursed by Medicaid or other state programs apply regardless of the payor.
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•
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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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•
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partners may not commit sufficient resources to the testing, marketing, distribution or other development of our drug candidates;
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•
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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;
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•
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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);
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•
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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
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•
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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.
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•
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our ability to create valuable proprietary drugs targeting large market opportunities;
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•
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research and spending priorities of potential licensing partners;
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•
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willingness of, and the resources available to, pharmaceutical and biotechnology companies to in-license drug candidates to fill their clinical pipelines;
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•
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the success or failure, and timing, of preclinical and clinical trials for our proprietary programs we intend to out-license; or
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•
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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.
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•
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failure to achieve clinical trial results that indicate a candidate is effective in treating a specified condition or illness in humans;
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•
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presence of harmful side effects;
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•
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determination by the FDA that the submitted data do not satisfy the criteria for approval;
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•
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lack of commercial viability of the drug;
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•
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failure to acquire, on reasonable terms, intellectual property rights necessary for commercialization; and
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•
|
existence of alternative therapeutics that are more effective.
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•
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provide sufficient safety, efficacy or other data regarding a drug candidate to support the commencement of a Phase 3 or other clinical trial;
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•
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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;
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•
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select CROs, trial sites and, where necessary, contract manufacturers that do not encounter any regulatory compliance problems;
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•
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manufacture sufficient quantities of a product candidate for use in clinical trials;
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•
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obtain IRB approval to conduct a clinical trial at a prospective site;
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•
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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; and
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•
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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.
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•
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failure to conduct the clinical trial in accordance with regulatory requirements, including GCP, or our protocols;
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•
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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;
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•
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unforeseen safety issues or results that do not demonstrate efficacy; and
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•
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lack of adequate funding to continue the clinical trial.
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•
|
the federal anti-kickback law prohibiting bribes, kickbacks or other remuneration for the order, purchase or recommendation of items or services reimbursed by federal health care programs;
|
•
|
the federal False Claims Act, imposing criminal and civil penalties for knowingly presenting or causing to be presented claims to the federal government that are false or fraudulent; and
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•
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the federal Physician Payment Sunshine Act, requiring pharmaceutical manufacturers to engage in extensive tracking of physician and teaching hospital payments, maintenance of a payments database and public reporting of the payment data.
|
•
|
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;
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•
|
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
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•
|
timing and outcome of product quality testing.
|
•
|
develop and implement drug discovery technologies that will result in the identification of higher quality drug candidates;
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•
|
attract and retain experienced, high caliber scientists;
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•
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achieve timely, high-quality results at an acceptable cost; and
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•
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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, 2014
|
|
High
|
|
Low
|
||||
First Quarter
|
|
$
|
7.10
|
|
|
$
|
4.54
|
|
Second Quarter
|
|
$
|
6.66
|
|
|
$
|
4.54
|
|
Third Quarter
|
|
$
|
5.64
|
|
|
$
|
4.32
|
|
Fourth Quarter
|
|
$
|
4.94
|
|
|
$
|
3.39
|
|
|
|
|
|
|
||||
Fiscal Year Ended June 30, 2013
|
|
High
|
|
Low
|
||||
First Quarter
|
|
$
|
6.16
|
|
|
$
|
3.30
|
|
Second Quarter
|
|
$
|
6.17
|
|
|
$
|
3.25
|
|
Third Quarter
|
|
$
|
5.00
|
|
|
$
|
3.66
|
|
Fourth Quarter
|
|
$
|
6.56
|
|
|
$
|
4.42
|
|
|
6/30/2009
|
|
6/30/2010
|
|
6/30/2011
|
|
6/30/2012
|
|
6/30/2013
|
|
6/30/2014
|
||||||
Array BioPharma Inc.
|
100.00
|
|
|
97.13
|
|
|
71.34
|
|
|
110.51
|
|
|
144.59
|
|
|
145.22
|
|
NASDAQ Composite
|
100.00
|
|
|
115.98
|
|
|
153.93
|
|
|
164.70
|
|
|
193.69
|
|
|
254.06
|
|
NASDAQ Biotechnology
|
100.00
|
|
|
107.01
|
|
|
149.61
|
|
|
183.05
|
|
|
247.08
|
|
|
366.88
|
|
|
Year Ended June 30,
|
||||||||||||||||||
|
2014
|
|
2013
|
|
2012
|
|
2011
|
|
2010
|
||||||||||
Revenue
|
|
|
|
|
|
|
|
|
|
||||||||||
License and milestone revenue
|
$
|
25,111
|
|
|
$
|
56,726
|
|
|
$
|
71,249
|
|
|
$
|
53,426
|
|
|
$
|
32,485
|
|
Collaboration revenue
|
16,967
|
|
|
12,854
|
|
|
13,886
|
|
|
18,475
|
|
|
21,395
|
|
|||||
Total revenue
|
42,078
|
|
|
69,580
|
|
|
85,135
|
|
|
71,901
|
|
|
53,880
|
|
|||||
Operating expenses
|
|
|
|
|
|
|
|
|
|
||||||||||
Cost of partnered programs
|
45,965
|
|
|
30,078
|
|
|
24,261
|
|
|
28,916
|
|
|
28,322
|
|
|||||
Research and development for proprietary programs
|
49,824
|
|
|
59,420
|
|
|
56,719
|
|
|
63,498
|
|
|
72,488
|
|
|||||
General and administrative
|
21,907
|
|
|
19,624
|
|
|
15,202
|
|
|
16,261
|
|
|
17,121
|
|
|||||
Total operating expenses
|
117,696
|
|
|
109,122
|
|
|
96,182
|
|
|
108,675
|
|
|
117,931
|
|
|||||
Loss from operations
|
(75,618
|
)
|
|
(39,542
|
)
|
|
(11,047
|
)
|
|
(36,774
|
)
|
|
(64,051
|
)
|
|||||
Other income (expense)
|
|
|
|
|
|
|
|
|
|
||||||||||
Realized gains on auction rate securities, net
|
—
|
|
|
—
|
|
|
—
|
|
|
1,891
|
|
|
1,305
|
|
|||||
Loss on prepayment of long-term debt, net
|
—
|
|
|
(11,197
|
)
|
|
(942
|
)
|
|
(6,340
|
)
|
|
—
|
|
|||||
Interest income
|
77
|
|
|
55
|
|
|
32
|
|
|
406
|
|
|
864
|
|
|||||
Interest expense
|
(9,716
|
)
|
|
(11,258
|
)
|
|
(11,624
|
)
|
|
(15,507
|
)
|
|
(15,749
|
)
|
|||||
Total other expense, net
|
(9,639
|
)
|
|
(22,400
|
)
|
|
(12,534
|
)
|
|
(19,550
|
)
|
|
(13,580
|
)
|
|||||
Net loss
|
$
|
(85,257
|
)
|
|
$
|
(61,942
|
)
|
|
$
|
(23,581
|
)
|
|
$
|
(56,324
|
)
|
|
$
|
(77,631
|
)
|
Weighted average shares outstanding – basic and diluted
|
123,403
|
|
|
107,794
|
|
|
70,619
|
|
|
55,447
|
|
|
50,216
|
|
|||||
Net loss per share – basic and diluted
|
$
|
(0.69
|
)
|
|
$
|
(0.57
|
)
|
|
$
|
(0.33
|
)
|
|
$
|
(1.02
|
)
|
|
$
|
(1.55
|
)
|
|
June 30,
|
||||||||||||||||||
|
2014
|
|
2013
|
|
2012
|
|
2011
|
|
2010
|
||||||||||
Cash, cash equivalents and marketable securities
|
$
|
111,638
|
|
|
$
|
108,706
|
|
|
$
|
89,650
|
|
|
$
|
64,708
|
|
|
$
|
128,869
|
|
Working capital
|
68,943
|
|
|
70,732
|
|
|
17,171
|
|
|
754
|
|
|
39,367
|
|
|||||
Total assets
|
139,053
|
|
|
135,988
|
|
|
108,073
|
|
|
89,374
|
|
|
159,179
|
|
|||||
Long-term debt, net
|
103,952
|
|
|
99,021
|
|
|
92,256
|
|
|
91,540
|
|
|
112,825
|
|
|||||
Total stockholders' deficit
|
(25,721
|
)
|
|
(21,909
|
)
|
|
(85,806
|
)
|
|
(130,858
|
)
|
|
(116,678
|
)
|
ITEM 7.
|
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
|
|
|
Proprietary Program
|
|
Indication
|
|
Clinical Status
|
1.
|
|
Filanesib
|
|
KSP inhibitor for MM
|
|
Phase 2
|
2.
|
|
ARRY-797
|
|
p38 inhibitor for LMNA-DCM
|
|
Phase 2
|
3.
|
|
ARRY-502
|
|
CRTh2 antagonist for asthma
|
|
Phase 2
|
4.
|
|
ARRY-614
|
|
p38/Tie2 dual inhibitor for MDS
|
|
Phase 1
|
|
|
Drug Candidate
|
|
Indication
|
|
Partner
|
|
Clinical Status
|
1.
|
|
Binimetinib
|
|
MEK inhibitor for cancer
|
|
Novartis International Pharmaceutical Ltd.
|
|
Phase 3
|
2.
|
|
Selumetinib
|
|
MEK inhibitor for cancer
|
|
AstraZeneca, PLC
|
|
Phase 3
|
3.
|
|
ASLAN001/ARRY-543
|
|
HER2 / EGFR inhibitor for gastric cancer
|
|
ASLAN Pharmaceuticals Pte Ltd.
|
|
Phase 2
|
4.
|
|
Ipatasertib/GDC-0068
|
|
AKT inhibitor for cancer
|
|
Genentech, Inc.
|
|
Phase 2
|
5.
|
|
VTX-2337
|
|
Toll-like receptor for cancer
|
|
VentiRx Pharmaceuticals, Inc.
|
|
Phase 2
|
6.
|
|
Danoprevir
|
|
Hepatitis C virus protease inhibitor
|
|
InterMune (danoprevir now owned by Roche Holding AG)
|
|
Phase 2
|
7.
|
|
LY2606368
|
|
Chk-1 inhibitor for cancer
|
|
Eli Lilly and Company
|
|
Phase 2
|
8.
|
|
GDC-0575
|
|
Chk-1 inhibitor for cancer
|
|
Genentech, Inc.
|
|
Phase 1b
|
9.
|
|
ARRY-380/ONT-380
|
|
HER2 inhibitor for breast cancer
|
|
Oncothyreon Inc.
|
|
Phase 1b
|
10.
|
|
GDC-0994
|
|
ERK inhibitor for cancer
|
|
Genentech, Inc.
|
|
Phase 1
|
11.
|
|
LOXO-101
|
|
PanTrk inhibitor for cancer
|
|
Loxo Oncology, Inc.
|
|
Phase 1
|
|
|
|
|
|
|
|
Change
|
|
Change
|
||||||||||||||||
|
Year Ended June 30,
|
|
2014 vs. 2013
|
|
2013 vs. 2012
|
||||||||||||||||||||
|
2014
|
|
2013
|
|
2012
|
|
$
|
|
%
|
|
$
|
|
%
|
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
License revenue
|
$
|
14,461
|
|
|
$
|
41,440
|
|
|
$
|
52,006
|
|
|
$
|
(26,979
|
)
|
|
(65
|
)%
|
|
$
|
(10,566
|
)
|
|
(20
|
)%
|
Milestone revenue
|
10,650
|
|
|
15,286
|
|
|
19,243
|
|
|
(4,636
|
)
|
|
(30
|
)%
|
|
(3,957
|
)
|
|
(21
|
)%
|
|||||
Total license and milestone revenue
|
$
|
25,111
|
|
|
$
|
56,726
|
|
|
$
|
71,249
|
|
|
$
|
(31,615
|
)
|
|
(56
|
)%
|
|
$
|
(14,523
|
)
|
|
(20
|
)%
|
|
|
|
|
|
|
|
Change
|
|
Change
|
||||||||||||||||
|
Year Ended June 30,
|
|
2014 vs. 2013
|
|
2013 vs. 2012
|
||||||||||||||||||||
|
2014
|
|
2013
|
|
2012
|
|
$
|
|
%
|
|
$
|
|
%
|
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Collaboration revenue
|
$
|
16,967
|
|
|
$
|
12,854
|
|
|
$
|
13,886
|
|
|
$
|
4,113
|
|
|
32
|
%
|
|
$
|
(1,032
|
)
|
|
(7
|
)%
|
|
|
|
|
|
|
|
Change
|
|
Change
|
||||||||||||||||
|
Year Ended June 30,
|
|
2014 vs. 2013
|
|
2013 vs. 2012
|
||||||||||||||||||||
|
2014
|
|
2013
|
|
2012
|
|
$
|
|
%
|
|
$
|
|
%
|
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Cost of partnered programs
|
$
|
45,965
|
|
|
$
|
30,078
|
|
|
$
|
24,261
|
|
|
$
|
15,887
|
|
|
53
|
%
|
|
$
|
5,817
|
|
|
24
|
%
|
Cost of partnered programs as a percentage of total revenue
|
109
|
%
|
|
43
|
%
|
|
28
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change
|
|
Change
|
||||||||||||||||
|
Year Ended June 30,
|
|
2014 vs. 2013
|
|
2013 vs. 2012
|
||||||||||||||||||||
|
2014
|
|
2013
|
|
2012
|
|
$
|
|
%
|
|
$
|
|
%
|
||||||||||||
Salaries, benefits and share-based compensation
|
$
|
18,443
|
|
|
$
|
24,080
|
|
|
$
|
22,832
|
|
|
$
|
(5,637
|
)
|
|
(23
|
)%
|
|
$
|
1,248
|
|
|
5
|
%
|
Outsourced services and consulting
|
18,170
|
|
|
19,634
|
|
|
17,680
|
|
|
(1,464
|
)
|
|
(7
|
)%
|
|
1,954
|
|
|
11
|
%
|
|||||
Laboratory supplies
|
5,756
|
|
|
6,887
|
|
|
6,652
|
|
|
(1,131
|
)
|
|
(16
|
)%
|
|
235
|
|
|
4
|
%
|
|||||
Facilities and depreciation
|
6,069
|
|
|
7,115
|
|
|
8,066
|
|
|
(1,046
|
)
|
|
(15
|
)%
|
|
(951
|
)
|
|
(12
|
)%
|
|||||
Other
|
1,386
|
|
|
1,704
|
|
|
1,489
|
|
|
(318
|
)
|
|
(19
|
)%
|
|
215
|
|
|
14
|
%
|
|||||
Total research and development expenses
|
$
|
49,824
|
|
|
$
|
59,420
|
|
|
$
|
56,719
|
|
|
$
|
(9,596
|
)
|
|
(16
|
)%
|
|
$
|
2,701
|
|
|
5
|
%
|
|
|
|
|
|
|
|
Change
|
|
Change
|
||||||||||||||||
|
Year Ended June 30,
|
|
2014 vs. 2013
|
|
2013 vs. 2012
|
||||||||||||||||||||
|
2014
|
|
2013
|
|
2012
|
|
$
|
|
%
|
|
$
|
|
%
|
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
General and administrative expenses
|
$
|
21,907
|
|
|
$
|
19,624
|
|
|
$
|
15,202
|
|
|
$
|
2,283
|
|
|
12
|
%
|
|
$
|
4,422
|
|
|
29
|
%
|
|
|
|
|
|
|
|
Change
|
|
Change
|
||||||||||||||||
|
Year Ended June 30,
|
|
2014 vs. 2013
|
|
2013 vs. 2012
|
||||||||||||||||||||
|
2014
|
|
2013
|
|
2012
|
|
$
|
|
%
|
|
$
|
|
%
|
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Loss on prepayment of long-term debt, net
|
$
|
—
|
|
|
$
|
(11,197
|
)
|
|
$
|
(942
|
)
|
|
$
|
11,197
|
|
|
100
|
%
|
|
$
|
(10,255
|
)
|
|
(1,089
|
)%
|
Interest income
|
77
|
|
|
55
|
|
|
32
|
|
|
22
|
|
|
40
|
%
|
|
23
|
|
|
72
|
%
|
|||||
Interest expense
|
(9,716
|
)
|
|
(11,258
|
)
|
|
(11,624
|
)
|
|
1,542
|
|
|
14
|
%
|
|
366
|
|
|
3
|
%
|
|||||
Total other expense, net
|
$
|
(9,639
|
)
|
|
$
|
(22,400
|
)
|
|
$
|
(12,534
|
)
|
|
$
|
12,761
|
|
|
57
|
%
|
|
$
|
(9,866
|
)
|
|
(79
|
)%
|
|
Year Ended June 30,
|
||||||||||
|
2014
|
|
2013
|
|
2012
|
||||||
Comerica Term Loan
|
|
|
|
|
|
||||||
Simple interest
|
$
|
479
|
|
|
$
|
483
|
|
|
$
|
489
|
|
Amortization of fees paid for letters of credit
|
48
|
|
|
107
|
|
|
108
|
|
|||
Total interest expense on the Comerica term loan
|
527
|
|
|
590
|
|
|
597
|
|
|||
|
|
|
|
|
|
||||||
Convertible Senior Notes
|
|
|
|
|
|
||||||
Contractual interest
|
3,979
|
|
|
221
|
|
|
—
|
|
|||
Amortization of debt discount
|
4,932
|
|
|
259
|
|
|
—
|
|
|||
Amortization of debt issuance costs
|
278
|
|
|
14
|
|
|
—
|
|
|||
Total interest expense on the convertible senior notes
|
9,189
|
|
|
494
|
|
|
—
|
|
|||
|
|
|
|
|
|
||||||
Deerfield Credit Facilities
|
|
|
|
|
|
||||||
Simple interest
|
—
|
|
|
6,078
|
|
|
6,492
|
|
|||
Amortization of debt discounts and transaction fees
|
—
|
|
|
4,331
|
|
|
4,419
|
|
|||
Change in fair value of the embedded derivatives
|
—
|
|
|
(235
|
)
|
|
116
|
|
|||
Total interest expense on the Deerfield credit facilities
|
—
|
|
|
10,174
|
|
|
11,027
|
|
|||
Total interest expense
|
$
|
9,716
|
|
|
$
|
11,258
|
|
|
$
|
11,624
|
|
•
|
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 Oncothyreon.
|
•
|
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.
|
|
June 30,
|
|
Change
|
|
Change
|
||||||||||||||
|
2014
|
|
2013
|
|
2012
|
|
2014 vs. 2013
|
|
2013 vs. 2012
|
||||||||||
|
|
|
|
|
|
|
|
|
|
||||||||||
Cash and cash equivalents
|
$
|
68,591
|
|
|
$
|
60,736
|
|
|
$
|
55,799
|
|
|
$
|
7,855
|
|
|
$
|
4,937
|
|
Marketable securities – short-term
|
42,407
|
|
|
47,505
|
|
|
33,378
|
|
|
(5,098
|
)
|
|
14,127
|
|
|||||
Marketable securities – long-term
|
640
|
|
|
465
|
|
|
473
|
|
|
175
|
|
|
(8
|
)
|
|||||
Total
|
$
|
111,638
|
|
|
$
|
108,706
|
|
|
$
|
89,650
|
|
|
$
|
2,932
|
|
|
$
|
19,056
|
|
|
Year Ended June 30,
|
|
Change
|
|
Change
|
||||||||||||||
|
2014
|
|
2013
|
|
2012
|
|
2014 vs. 2013
|
|
2013 vs. 2012
|
||||||||||
Cash flows provided by (used in):
|
|
|
|
|
|
|
|
|
|
||||||||||
Operating activities
|
$
|
(71,682
|
)
|
|
$
|
(87,067
|
)
|
|
$
|
(33,546
|
)
|
|
$
|
15,385
|
|
|
$
|
(53,521
|
)
|
Investing activities
|
2,482
|
|
|
(16,362
|
)
|
|
(18,721
|
)
|
|
18,844
|
|
|
2,359
|
|
|||||
Financing activities
|
77,055
|
|
|
108,366
|
|
|
59,967
|
|
|
(31,311
|
)
|
|
48,399
|
|
|||||
Total
|
$
|
7,855
|
|
|
$
|
4,937
|
|
|
$
|
7,700
|
|
|
$
|
2,918
|
|
|
$
|
(2,763
|
)
|
|
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)
|
4,440
|
|
|
8,880
|
|
|
8,093
|
|
|
3,648
|
|
|
25,061
|
|
|||||
Co-development liability (1)(5)
|
16,155
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
16,155
|
|
|||||
Operating lease commitments (2)
|
8,316
|
|
|
8,706
|
|
|
—
|
|
|
—
|
|
|
17,022
|
|
|||||
Purchase obligations (2)(6)
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Total
|
$
|
28,911
|
|
|
$
|
17,586
|
|
|
$
|
22,643
|
|
|
$
|
135,898
|
|
|
$
|
205,038
|
|
(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 3.25%, the interest rate in effect as of
June 30, 2014
.
|
(4)
|
Interest on the 2020 Notes is calculated at 3.00%, which is the coupon rate.
|
(5)
|
Co-development liability primarily represents the amount payable to Novartis for our share of co-development costs for development of the binimetinib program through fiscal 2014.
|
(6)
|
We have open purchase orders for $119.8 million, which include $85.7 million for CROs, $30.8 million for other outsourced services for clinical trials and research and development costs and $3.3 million for all other purchase commitments. 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)
|
|
10,194,817
|
|
|
$4.84
|
|
23,131,696
|
|
|
|
|
|
|
|
|
|
|||
ESPP
|
|
—
|
|
|
—
|
|
|
491,649
|
|
|
|
|
|
|
|
|
|||
Total
|
|
10,194,817
|
|
|
|
|
23,623,345
|
|
(1)
|
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 14, 2014
|
Ron Squarer
|
|
(Principal Executive Officer)
|
|
|
|
|
|
|
|
/s/ KYLE A. LEFKOFF
|
|
Chairman of the Board of Directors
|
|
August 14, 2014
|
Kyle A. Lefkoff
|
|
|
|
|
|
|
|
|
|
/s/ R. MICHAEL CARRUTHERS
|
|
Chief Financial Officer
|
|
August 14, 2014
|
R. Michael Carruthers
|
|
(Principal Financial and Accounting Officer)
|
|
|
|
|
|
|
|
/s/ CHARLES M. BAUM
|
|
Director
|
|
August 14, 2014
|
Charles M. Baum, M.D., Ph.D.
|
|
|
|
|
|
|
|
|
|
/s/ GWEN A. FYFE
|
|
Director
|
|
August 14, 2014
|
Gwen A. Fyfe, M.D.
|
|
|
|
|
|
|
|
|
|
/s/ JOHN A. ORWIN
|
|
Director
|
|
August 14, 2014
|
John A. Orwin
|
|
|
|
|
|
|
|
|
|
/s/ GIL J. VAN LUNSEN
|
|
Director
|
|
August 14, 2014
|
Gil J. Van Lunsen
|
|
|
|
|
|
|
|
|
|
Description
|
|
Page No.
|
|
|
|
|
||
|
||
|
||
|
||
|
||
|
||
|
||
|
By:
|
/s/ RON SQUARER
|
|
Ron Squarer
|
|
Chief Executive Officer
|
By:
|
/s/ R. MICHAEL CARRUTHERS
|
|
R. Michael Carruthers
|
|
Chief Financial Officer
|
|
June 30,
|
||||||
|
2014
|
|
2013
|
||||
Assets
|
|
|
|
||||
Current assets
|
|
|
|
||||
Cash and cash equivalents
|
$
|
68,591
|
|
|
$
|
60,736
|
|
Marketable securities
|
42,407
|
|
|
47,505
|
|
||
Accounts receivable
|
5,429
|
|
|
9,595
|
|
||
Prepaid expenses and other current assets
|
5,249
|
|
|
3,473
|
|
||
Total current assets
|
121,676
|
|
|
121,309
|
|
||
|
|
|
|
||||
Long-term assets
|
|
|
|
||||
Marketable securities
|
640
|
|
|
465
|
|
||
Property and equipment, net
|
8,157
|
|
|
10,049
|
|
||
Other long-term assets
|
8,580
|
|
|
4,165
|
|
||
Total long-term assets
|
17,377
|
|
|
14,679
|
|
||
Total assets
|
$
|
139,053
|
|
|
$
|
135,988
|
|
|
|
|
|
||||
Liabilities and Stockholders' Deficit
|
|
|
|
||||
Current liabilities
|
|
|
|
||||
Accounts payable
|
$
|
6,953
|
|
|
$
|
5,396
|
|
Accrued outsourcing costs
|
10,040
|
|
|
5,576
|
|
||
Accrued compensation and benefits
|
8,209
|
|
|
9,481
|
|
||
Other accrued expenses
|
1,444
|
|
|
1,135
|
|
||
Co-development liability
|
16,155
|
|
|
10,990
|
|
||
Deferred rent
|
3,739
|
|
|
3,646
|
|
||
Deferred revenue
|
6,193
|
|
|
14,353
|
|
||
Total current liabilities
|
52,733
|
|
|
50,577
|
|
||
|
|
|
|
||||
Long-term liabilities
|
|
|
|
||||
Deferred rent
|
4,096
|
|
|
7,834
|
|
||
Deferred revenue
|
3,353
|
|
|
—
|
|
||
Long-term debt, net
|
103,952
|
|
|
99,021
|
|
||
Other long-term liabilities
|
640
|
|
|
465
|
|
||
Total long-term liabilities
|
112,041
|
|
|
107,320
|
|
||
Total liabilities
|
164,774
|
|
|
157,897
|
|
||
|
|
|
|
||||
Commitments and contingencies
|
|
|
|
||||
|
|
|
|
||||
Stockholders' deficit
|
|
|
|
||||
Preferred stock, $0.001 par value; 10,000,000 shares authorized, no shares issued and outstanding
|
—
|
|
|
—
|
|
||
Common stock, $0.001 par value; 220,000,000 shares authorized; 131,817,422 and 116,878,021 shares issued and outstanding as of June 30, 2014 and 2013, respectively
|
132
|
|
|
117
|
|
||
Additional paid-in capital
|
652,696
|
|
|
571,270
|
|
||
Warrants
|
39,385
|
|
|
39,385
|
|
||
Accumulated other comprehensive income (loss)
|
2
|
|
|
(2
|
)
|
||
Accumulated deficit
|
(717,936
|
)
|
|
(632,679
|
)
|
||
Total stockholders' deficit
|
(25,721
|
)
|
|
(21,909
|
)
|
||
Total liabilities and stockholders' deficit
|
$
|
139,053
|
|
|
$
|
135,988
|
|
|
|
|
|
||||
The accompanying notes are an integral part of these financial statements.
|
|
Year Ended June 30,
|
||||||||||
|
2014
|
|
2013
|
|
2012
|
||||||
Revenue
|
|
|
|
|
|
||||||
License and milestone revenue
|
$
|
25,111
|
|
|
$
|
56,726
|
|
|
$
|
71,249
|
|
Collaboration revenue
|
16,967
|
|
|
12,854
|
|
|
13,886
|
|
|||
Total revenue
|
42,078
|
|
|
69,580
|
|
|
85,135
|
|
|||
|
|
|
|
|
|
||||||
Operating expenses
|
|
|
|
|
|
||||||
Cost of partnered programs
|
45,965
|
|
|
30,078
|
|
|
24,261
|
|
|||
Research and development for proprietary programs
|
49,824
|
|
|
59,420
|
|
|
56,719
|
|
|||
General and administrative
|
21,907
|
|
|
19,624
|
|
|
15,202
|
|
|||
Total operating expenses
|
117,696
|
|
|
109,122
|
|
|
96,182
|
|
|||
|
|
|
|
|
|
||||||
Loss from operations
|
(75,618
|
)
|
|
(39,542
|
)
|
|
(11,047
|
)
|
|||
|
|
|
|
|
|
||||||
Other income (expense)
|
|
|
|
|
|
||||||
Loss on prepayment of long-term debt, net
|
—
|
|
|
(11,197
|
)
|
|
(942
|
)
|
|||
Interest income
|
77
|
|
|
55
|
|
|
32
|
|
|||
Interest expense
|
(9,716
|
)
|
|
(11,258
|
)
|
|
(11,624
|
)
|
|||
Total other expense, net
|
(9,639
|
)
|
|
(22,400
|
)
|
|
(12,534
|
)
|
|||
|
|
|
|
|
|
||||||
Net loss
|
$
|
(85,257
|
)
|
|
$
|
(61,942
|
)
|
|
$
|
(23,581
|
)
|
|
|
|
|
|
|
||||||
Change in unrealized gains and losses on marketable securities
|
4
|
|
|
(1
|
)
|
|
(4
|
)
|
|||
|
|
|
|
|
|
||||||
Comprehensive loss
|
$
|
(85,253
|
)
|
|
$
|
(61,943
|
)
|
|
$
|
(23,585
|
)
|
|
|
|
|
|
|
||||||
Weighted average shares outstanding – basic and diluted
|
123,403
|
|
|
107,794
|
|
|
70,619
|
|
|||
|
|
|
|
|
|
||||||
Net loss per share – basic and diluted
|
$
|
(0.69
|
)
|
|
$
|
(0.57
|
)
|
|
$
|
(0.33
|
)
|
|
|
|
|
|
|
||||||
The accompanying notes are an integral part of these financial statements.
|
|
|
|
|
|
|
|
|
|
Additional Paid-in Capital
|
|
Warrants
|
|
Accumulated Other Comprehensive Income (Loss)
|
|
Accumulated Deficit
|
|
Total
|
||||||||||||||||
|
Preferred Stock
|
|
Common Stock
|
|
|
|
|
|
|||||||||||||||||||||||||
|
Shares
|
|
Amounts
|
|
Shares
|
|
Amounts
|
|
|
|
|
|
|||||||||||||||||||||
Balance as of July 1, 2011
|
10
|
|
|
$
|
30,000
|
|
|
57,020
|
|
|
$
|
57
|
|
|
$
|
346,853
|
|
|
$
|
39,385
|
|
|
$
|
3
|
|
|
$
|
(547,156
|
)
|
|
$
|
(130,858
|
)
|
Issuance of common stock under stock option and employee stock purchase plans
|
—
|
|
|
—
|
|
|
581
|
|
|
1
|
|
|
1,168
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,169
|
|
|||||||
Share-based compensation expense
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2,351
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2,351
|
|
|||||||
Issuance of common stock, net of offering costs
|
—
|
|
|
—
|
|
|
25,936
|
|
|
26
|
|
|
63,122
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
63,148
|
|
|||||||
Conversion of preferred stock to common
|
(7
|
)
|
|
(21,946
|
)
|
|
7,414
|
|
|
7
|
|
|
21,939
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||||
Payment of employee bonus with stock
|
—
|
|
|
—
|
|
|
1,113
|
|
|
1
|
|
|
1,968
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,969
|
|
|||||||
Change in unrealized gain on marketable securities
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(4
|
)
|
|
—
|
|
|
(4
|
)
|
|||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(23,581
|
)
|
|
(23,581
|
)
|
|||||||
Balance as of June 30, 2012
|
3
|
|
|
8,054
|
|
|
92,064
|
|
|
92
|
|
|
437,401
|
|
|
39,385
|
|
|
(1
|
)
|
|
(570,737
|
)
|
|
(85,806
|
)
|
|||||||
Issuance of common stock under stock option and employee stock purchase plans
|
—
|
|
|
—
|
|
|
900
|
|
|
1
|
|
|
2,119
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2,120
|
|
|||||||
Share-based compensation expense
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
3,449
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
3,449
|
|
|||||||
Issuance of common stock, net of offering costs
|
—
|
|
|
—
|
|
|
20,700
|
|
|
21
|
|
|
70,875
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
70,896
|
|
|||||||
Conversion of preferred stock to common
|
(3
|
)
|
|
(8,054
|
)
|
|
2,721
|
|
|
3
|
|
|
8,051
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||||
Payment of employee bonus with stock
|
—
|
|
|
—
|
|
|
493
|
|
|
—
|
|
|
2,857
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2,857
|
|
|||||||
Issuance of convertible senior notes, equity portion, net of offering costs
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
46,518
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
46,518
|
|
|||||||
Change in unrealized loss on marketable securities
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(1
|
)
|
|
—
|
|
|
(1
|
)
|
|||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(61,942
|
)
|
|
(61,942
|
)
|
|||||||
Balance as of June 30, 2013
|
—
|
|
|
—
|
|
|
116,878
|
|
|
117
|
|
|
571,270
|
|
|
39,385
|
|
|
(2
|
)
|
|
(632,679
|
)
|
|
(21,909
|
)
|
|||||||
Issuance of common stock under stock option and employee stock purchase plans
|
—
|
|
|
—
|
|
|
1,132
|
|
|
1
|
|
|
3,692
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
3,693
|
|
|||||||
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
|
|
|
$
|
652,696
|
|
|
$
|
39,385
|
|
|
$
|
2
|
|
|
$
|
(717,936
|
)
|
|
$
|
(25,721
|
)
|
|
|||||||||||||||||||||||||||||||||
The accompanying notes are an integral part of these financial statements.
|
|
Year Ended June 30,
|
||||||||||
|
2014
|
|
2013
|
|
2012
|
||||||
Cash flows from operating activities
|
|
|
|
|
|
||||||
Net loss
|
$
|
(85,257
|
)
|
|
$
|
(61,942
|
)
|
|
$
|
(23,581
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
||||||
Depreciation and amortization expense
|
4,506
|
|
|
4,350
|
|
|
5,076
|
|
|||
Non-cash interest expense
|
5,258
|
|
|
4,476
|
|
|
4,643
|
|
|||
Loss on prepayment of long-term debt
|
—
|
|
|
11,197
|
|
|
942
|
|
|||
Share-based compensation expense
|
4,331
|
|
|
3,449
|
|
|
2,351
|
|
|||
Payment of employee bonus with stock
|
—
|
|
|
2,857
|
|
|
1,969
|
|
|||
Non-cash license revenue
|
(4,500
|
)
|
|
—
|
|
|
—
|
|
|||
Changes in operating assets and liabilities:
|
|
|
|
|
|
||||||
Accounts receivable
|
4,166
|
|
|
(8,520
|
)
|
|
1,157
|
|
|||
Prepaid expenses and other assets
|
(1,961
|
)
|
|
(746
|
)
|
|
1,044
|
|
|||
Accounts payable and other accrued expenses
|
1,866
|
|
|
(1,324
|
)
|
|
1,084
|
|
|||
Accrued outsourcing costs
|
4,464
|
|
|
182
|
|
|
146
|
|
|||
Accrued compensation and benefits
|
(1,272
|
)
|
|
1,951
|
|
|
1,099
|
|
|||
Co-development liability
|
5,165
|
|
|
1,812
|
|
|
5,581
|
|
|||
Deferred rent
|
(3,645
|
)
|
|
(3,489
|
)
|
|
(3,332
|
)
|
|||
Deferred revenue
|
(4,807
|
)
|
|
(41,214
|
)
|
|
(31,613
|
)
|
|||
Other liabilities
|
4
|
|
|
(106
|
)
|
|
(112
|
)
|
|||
Net cash used in operating activities
|
(71,682
|
)
|
|
(87,067
|
)
|
|
(33,546
|
)
|
|||
|
|
|
|
|
|
||||||
Cash flows from investing activities
|
|
|
|
|
|
||||||
Purchases of property and equipment
|
(2,614
|
)
|
|
(2,340
|
)
|
|
(1,437
|
)
|
|||
Purchases of marketable securities
|
(95,602
|
)
|
|
(110,723
|
)
|
|
(51,339
|
)
|
|||
Proceeds from sales and maturities of marketable securities
|
100,698
|
|
|
96,701
|
|
|
34,055
|
|
|||
Net cash provided by (used in) investing activities
|
2,482
|
|
|
(16,362
|
)
|
|
(18,721
|
)
|
|||
|
|
|
|
|
|
||||||
Cash flows from financing activities
|
|
|
|
|
|
||||||
Proceeds from the issuance of convertible senior notes
|
—
|
|
|
132,250
|
|
|
—
|
|
|||
Payments of long-term debt principal
|
—
|
|
|
(92,712
|
)
|
|
(4,350
|
)
|
|||
Proceeds from the issuance of common stock
|
75,000
|
|
|
75,555
|
|
|
67,145
|
|
|||
Proceeds from employee stock purchases and options exercised
|
3,693
|
|
|
2,120
|
|
|
1,169
|
|
|||
Payment of debt issuance costs
|
(86
|
)
|
|
(4,188
|
)
|
|
—
|
|
|||
Payment of stock offering costs
|
(1,552
|
)
|
|
(4,659
|
)
|
|
(3,997
|
)
|
|||
Net cash provided by financing activities
|
77,055
|
|
|
108,366
|
|
|
59,967
|
|
|||
|
|
|
|
|
|
||||||
Net increase in cash and cash equivalents
|
7,855
|
|
|
4,937
|
|
|
7,700
|
|
|||
Cash and cash equivalents at beginning of period
|
60,736
|
|
|
55,799
|
|
|
48,099
|
|
|||
Cash and cash equivalents at end of period
|
$
|
68,591
|
|
|
$
|
60,736
|
|
|
$
|
55,799
|
|
|
|
|
|
|
|
||||||
Supplemental disclosure of cash flow information
|
|
|
|
|
|
||||||
Cash paid for interest
|
$
|
4,349
|
|
|
$
|
6,564
|
|
|
$
|
7,008
|
|
•
|
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,
|
|||||||
|
2014
|
|
2013
|
|
2012
|
|||
|
|
|
|
|
|
|||
Novartis International Pharmaceutical Ltd.
|
28.6
|
%
|
|
25.5
|
%
|
|
16.2
|
%
|
Loxo Oncology, Inc.
|
23.1
|
|
|
—
|
|
|
—
|
|
AstraZeneca AB
|
12.1
|
|
|
0.2
|
|
|
—
|
|
Celgene
|
8.9
|
|
|
20.6
|
|
|
6.9
|
|
Genentech, Inc.
|
8.5
|
|
|
11.0
|
|
|
40.8
|
|
Oncothyreon Inc.
|
8.2
|
|
|
14.4
|
|
|
—
|
|
Amgen Inc.
|
—
|
|
|
16.0
|
|
|
34.2
|
|
|
89.4
|
%
|
|
87.7
|
%
|
|
98.1
|
%
|
|
Year Ended June 30,
|
||||||||||
|
2014
|
|
2013
|
|
2012
|
||||||
|
|
|
|
|
|
||||||
North America
|
$
|
24,757
|
|
|
$
|
51,608
|
|
|
$
|
70,905
|
|
Europe
|
17,153
|
|
|
17,969
|
|
|
13,987
|
|
|||
Asia Pacific
|
168
|
|
|
3
|
|
|
243
|
|
|||
|
$
|
42,078
|
|
|
$
|
69,580
|
|
|
$
|
85,135
|
|
|
|
|
Gross
|
|
Gross
|
|
|
||||||||
|
Amortized
|
|
Unrealized
|
|
Unrealized
|
|
Fair
|
||||||||
|
Cost
|
|
Gains
|
|
Losses
|
|
Value
|
||||||||
Short-term available-for-sale securities:
|
|
|
|
|
|
|
|
||||||||
U.S. treasury securities
|
$
|
42,184
|
|
|
$
|
2
|
|
|
$
|
(1
|
)
|
|
$
|
42,185
|
|
Mutual fund securities
|
222
|
|
|
—
|
|
|
—
|
|
|
222
|
|
||||
|
42,406
|
|
|
2
|
|
|
(1
|
)
|
|
42,407
|
|
||||
Long-term available-for-sale securities:
|
|
|
|
|
|
|
|
||||||||
Mutual fund securities
|
640
|
|
|
—
|
|
|
—
|
|
|
640
|
|
||||
|
640
|
|
|
—
|
|
|
—
|
|
|
640
|
|
||||
Total
|
$
|
43,046
|
|
|
$
|
2
|
|
|
$
|
(1
|
)
|
|
$
|
43,047
|
|
|
|
|
Gross
|
|
Gross
|
|
|
||||||||
|
Amortized
|
|
Unrealized
|
|
Unrealized
|
|
Fair
|
||||||||
|
Cost
|
|
Gains
|
|
Losses
|
|
Value
|
||||||||
Short-term available-for-sale securities:
|
|
|
|
|
|
|
|
||||||||
U.S. treasury securities
|
$
|
47,130
|
|
|
$
|
—
|
|
|
$
|
(2
|
)
|
|
$
|
47,128
|
|
Mutual fund securities
|
377
|
|
|
—
|
|
|
—
|
|
|
377
|
|
||||
|
47,507
|
|
|
—
|
|
|
(2
|
)
|
|
47,505
|
|
||||
Long-term available-for-sale securities:
|
|
|
|
|
|
|
|
||||||||
Mutual fund securities
|
465
|
|
|
—
|
|
|
—
|
|
|
465
|
|
||||
|
465
|
|
|
—
|
|
|
—
|
|
|
465
|
|
||||
Total
|
$
|
47,972
|
|
|
$
|
—
|
|
|
$
|
(2
|
)
|
|
$
|
47,970
|
|
|
June 30,
|
||||||
|
2014
|
|
2013
|
||||
|
|
|
|
||||
Quoted prices in active markets for identical assets (Level 1)
|
$
|
43,047
|
|
|
$
|
47,970
|
|
Quoted prices for similar assets observable in the marketplace (Level 2)
|
—
|
|
|
—
|
|
||
Significant unobservable inputs (Level 3)
|
—
|
|
|
—
|
|
||
Total
|
$
|
43,047
|
|
|
$
|
47,970
|
|
|
Amortized
|
|
Fair
|
||||
|
Cost
|
|
Value
|
||||
|
|
|
|
||||
Due in one year or less
|
$
|
42,406
|
|
|
$
|
42,407
|
|
Due in one year to three years
|
640
|
|
|
640
|
|
||
Total
|
$
|
43,046
|
|
|
$
|
43,047
|
|
|
June 30,
|
||||||
|
2014
|
|
2013
|
||||
|
|
|
|
||||
Furniture and fixtures
|
$
|
3,421
|
|
|
$
|
3,396
|
|
Equipment
|
40,150
|
|
|
40,183
|
|
||
Computer hardware and software
|
14,705
|
|
|
13,552
|
|
||
Leasehold improvements
|
32,171
|
|
|
31,406
|
|
||
Property and equipment, gross
|
90,447
|
|
|
88,537
|
|
||
Less: accumulated depreciation and amortization
|
(82,290
|
)
|
|
(78,488
|
)
|
||
Property and equipment, net
|
$
|
8,157
|
|
|
$
|
10,049
|
|
|
June 30,
|
||||||
|
2014
|
|
2013
|
||||
|
|
|
|
||||
Celgene
|
$
|
7,258
|
|
|
$
|
—
|
|
Biogen Idec
|
1,218
|
|
|
—
|
|
||
Loxo Oncology, Inc.
|
625
|
|
|
—
|
|
||
Genentech, Inc.
|
367
|
|
|
2,300
|
|
||
Novartis International Pharmaceutical Ltd.
|
—
|
|
|
12,053
|
|
||
Other partners
|
78
|
|
|
—
|
|
||
Total deferred revenue
|
9,546
|
|
|
14,353
|
|
||
Less: Current portion
|
(6,193
|
)
|
|
(14,353
|
)
|
||
Deferred revenue, long-term portion
|
$
|
3,353
|
|
|
$
|
—
|
|
|
June 30,
|
||||||
|
2014
|
|
2013
|
||||
|
|
|
|
||||
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
|
(42,848
|
)
|
|
(47,779
|
)
|
||
Long-term debt, net
|
$
|
103,952
|
|
|
$
|
99,021
|
|
|
Year Ended June 30,
|
||||||
|
2013
|
|
2012
|
||||
|
|
|
|
||||
Write off proportional value or remaining balance of the debt discount
|
$
|
(10,898
|
)
|
|
$
|
(887
|
)
|
Write off proportional value or remaining balance of the unamortized debt issuance costs
|
(720
|
)
|
|
(55
|
)
|
||
Fair value adjustment for, or write off of, the embedded derivatives
|
421
|
|
|
—
|
|
||
Loss on prepayment of long-term debt, net
|
$
|
(11,197
|
)
|
|
$
|
(942
|
)
|
|
Year Ended June 30,
|
||||||||||
|
2014
|
|
2013
|
|
2012
|
||||||
Comerica Term Loan
|
|
|
|
|
|
||||||
Simple interest
|
$
|
479
|
|
|
$
|
483
|
|
|
$
|
489
|
|
Amortization of fees paid for letters of credit
|
48
|
|
|
107
|
|
|
108
|
|
|||
Total interest expense on the Comerica term loan
|
527
|
|
|
590
|
|
|
597
|
|
|||
|
|
|
|
|
|
||||||
Convertible Senior Notes
|
|
|
|
|
|
||||||
Contractual interest
|
3,979
|
|
|
221
|
|
|
—
|
|
|||
Amortization of debt discount
|
4,932
|
|
|
259
|
|
|
—
|
|
|||
Amortization of debt issuance costs
|
278
|
|
|
14
|
|
|
—
|
|
|||
Total interest expense on the convertible senior notes
|
9,189
|
|
|
494
|
|
|
—
|
|
|||
|
|
|
|
|
|
||||||
Deerfield Credit Facilities
|
|
|
|
|
|
||||||
Simple interest
|
—
|
|
|
6,078
|
|
|
6,492
|
|
|||
Amortization of debt discounts and transaction fees
|
—
|
|
|
4,331
|
|
|
4,419
|
|
|||
Change in fair value of the embedded derivatives
|
—
|
|
|
(235
|
)
|
|
116
|
|
|||
Total interest expense on the Deerfield credit facilities
|
—
|
|
|
10,174
|
|
|
11,027
|
|
|||
Total interest expense
|
$
|
9,716
|
|
|
$
|
11,258
|
|
|
$
|
11,624
|
|
|
Principal Due
|
||
|
|
||
2015
|
$
|
—
|
|
2016
|
—
|
|
|
2017
|
—
|
|
|
2018
|
14,550
|
|
|
2019
|
—
|
|
|
Thereafter
|
132,250
|
|
|
|
$
|
146,800
|
|
|
|
Rental Payments
|
||
|
|
|
||
2015
|
|
$
|
8,316
|
|
2016
|
|
8,338
|
|
|
2017
|
|
368
|
|
|
2018
|
|
—
|
|
|
2019
|
|
—
|
|
|
Thereafter
|
|
—
|
|
|
|
|
$
|
17,022
|
|
|
Year Ended June 30,
|
||||||||||
|
2014
|
|
2013
|
|
2012
|
||||||
|
|
|
|
|
|
||||||
Cash paid for rent
|
$
|
8,878
|
|
|
$
|
8,625
|
|
|
$
|
8,549
|
|
Deferred rent credits
|
(3,645
|
)
|
|
(3,489
|
)
|
|
(3,332
|
)
|
|||
Rent expense, net
|
$
|
5,233
|
|
|
$
|
5,136
|
|
|
$
|
5,217
|
|
(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.
|
•
|
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,
|
||||
|
2014
|
|
2013
|
|
2012
|
|
|
|
|
|
|
Risk-free interest rate
|
1.7% - 2.1%
|
|
0.8% - 1.2%
|
|
0.9% - 1.5%
|
Expected option term in years
|
6.25
|
|
6.25
|
|
6.25
|
Expected volatility
|
67.8% - 68.9%
|
|
66.0% - 67.5%
|
|
63.8% - 65.8%
|
Dividend yield
|
0%
|
|
0%
|
|
0%
|
Weighted-average grant date fair value
|
$2.91
|
|
$3.07
|
|
$2.04
|
|
Year Ended June 30,
|
|||||||
|
2014
|
|
2013
|
|
2012
|
|||
|
|
|
|
|
|
|||
U.S. federal income tax expense at the statutory rate
|
34.0
|
%
|
|
34.0
|
%
|
|
34.0
|
%
|
Interest expense disallowed under Sec.163(l)
|
0.0
|
|
|
(5.0
|
)
|
|
(15.6
|
)
|
Available research and experimentation tax credits
|
2.0
|
|
|
5.7
|
|
|
12.9
|
|
Stock-based compensation
|
(1.2
|
)
|
|
(3.8
|
)
|
|
(2.6
|
)
|
(Gain)/loss on early prepayment of debt
|
0.0
|
|
|
(6.1
|
)
|
|
(1.4
|
)
|
FIN 48 reserve releases
|
(0.3
|
)
|
|
(0.7
|
)
|
|
7.3
|
|
Rate change
|
0.0
|
|
|
(0.8
|
)
|
|
(2.2
|
)
|
Effect of other permanent differences
|
(0.1
|
)
|
|
0.2
|
|
|
0.0
|
|
State income taxes, net of federal taxes
|
3.1
|
|
|
2.0
|
|
|
1.4
|
|
Valuation allowance
|
(37.5
|
)
|
|
(25.5
|
)
|
|
(33.8
|
)
|
Total
|
0.0
|
%
|
|
0.0
|
%
|
|
0.0
|
%
|
|
June 30,
|
||||||
|
2014
|
|
2013
|
||||
Current deferred tax assets, gross
|
|
|
|
||||
Accrued benefits
|
$
|
2,402
|
|
|
$
|
2,725
|
|
Inventory reserve
|
1,514
|
|
|
1,203
|
|
||
Total current deferred tax assets
|
3,916
|
|
|
3,928
|
|
||
Non-current deferred tax assets, gross
|
|
|
|
||||
Net operating loss carryforwards
|
196,997
|
|
|
162,791
|
|
||
Capital loss carryforwards
|
6,095
|
|
|
6,094
|
|
||
Research and experimentation credit carryforwards
|
28,558
|
|
|
27,060
|
|
||
Deferred revenue
|
197
|
|
|
4,951
|
|
||
Deferred rent
|
2,909
|
|
|
4,261
|
|
||
Depreciation of property and equipment
|
7,666
|
|
|
6,885
|
|
||
Loan costs on convertible senior notes
|
469
|
|
|
565
|
|
||
Other
|
2,333
|
|
|
2,439
|
|
||
Total non-current deferred tax assets
|
245,224
|
|
|
215,046
|
|
||
Total deferred tax assets
|
249,140
|
|
|
218,974
|
|
||
Long-term deferred tax liability
|
|
|
|
||||
Discount on convertible senior notes
|
15,905
|
|
|
17,734
|
|
||
Total long-term deferred tax liability
|
15,905
|
|
|
17,734
|
|
||
Deferred tax assets, net of deferred tax liability
|
233,235
|
|
|
201,240
|
|
||
Valuation allowance
|
(233,235
|
)
|
|
(201,240
|
)
|
||
Deferred tax assets, net of valuation allowance
|
$
|
—
|
|
|
$
|
—
|
|
|
Year Ended June 30,
|
||||||
|
2014
|
|
2013
|
||||
|
|
|
|
||||
Balance at beginning of year
|
$
|
3,428
|
|
|
$
|
2,968
|
|
Additions based on tax positions related to the current year
|
712
|
|
|
915
|
|
||
Additions for tax positions of prior year
|
—
|
|
|
(2
|
)
|
||
Reductions for tax positions of prior year
|
(464
|
)
|
|
(453
|
)
|
||
Balance at end of year
|
$
|
3,676
|
|
|
$
|
3,428
|
|
Fiscal Year Ended June 30, 2014
|
|
First Quarter
|
|
Second Quarter
|
|
Third Quarter
|
|
Fourth Quarter
|
||||||||
Revenue
|
|
$
|
14,228
|
|
|
$
|
14,066
|
|
|
$
|
7,773
|
|
|
$
|
6,011
|
|
Research and development for proprietary programs
|
|
$
|
11,704
|
|
|
$
|
9,487
|
|
|
$
|
14,131
|
|
|
$
|
14,502
|
|
Total operating expenses
|
|
$
|
27,541
|
|
|
$
|
28,069
|
|
|
$
|
30,292
|
|
|
$
|
31,794
|
|
Net loss
|
|
$
|
(15,680
|
)
|
|
$
|
(16,408
|
)
|
|
$
|
(24,932
|
)
|
|
$
|
(28,237
|
)
|
Weighted average shares outstanding – basic and diluted
|
|
117,509
|
|
|
123,921
|
|
|
125,471
|
|
|
126,815
|
|
||||
Net loss per share – basic and diluted
|
|
$
|
(0.13
|
)
|
|
$
|
(0.13
|
)
|
|
$
|
(0.20
|
)
|
|
$
|
(0.22
|
)
|
Fiscal Year Ended June 30, 2013
|
|
First Quarter
|
|
Second Quarter
|
|
Third Quarter
|
|
Fourth Quarter
|
||||||||
Revenue
|
|
$
|
15,833
|
|
|
$
|
18,377
|
|
|
$
|
9,955
|
|
|
$
|
25,415
|
|
Research and development for proprietary programs
|
|
$
|
13,534
|
|
|
$
|
13,941
|
|
|
$
|
15,105
|
|
|
$
|
16,840
|
|
Total operating expenses
|
|
$
|
24,853
|
|
|
$
|
26,460
|
|
|
$
|
28,730
|
|
|
$
|
29,079
|
|
Net loss
|
|
$
|
(11,768
|
)
|
|
$
|
(10,931
|
)
|
|
$
|
(21,594
|
)
|
|
$
|
(17,649
|
)
|
Weighted average shares outstanding – basic and diluted
|
|
92,606
|
|
|
105,403
|
|
|
116,665
|
|
|
116,792
|
|
||||
Net loss per share – basic and diluted
|
|
$
|
(0.13
|
)
|
|
$
|
(0.10
|
)
|
|
$
|
(0.19
|
)
|
|
$
|
(0.15
|
)
|
|
|
|
|
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.
|
|
S-1/A
|
|
333-45922
|
|
10/27/2000
|
3.2
|
|
Amendment to Amended and Restated Certificate of Incorporation of Array BioPharma Inc.
|
|
8-K
|
|
001-16633
|
|
11/6/2007
|
3.3
|
|
Amendment to Amended and Restated Certificate of Incorporation of Array BioPharma Inc.
|
|
8-K
|
|
001-16633
|
|
10/29/2012
|
3.4
|
|
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
|
|
Registration Rights Agreement, dated May 15, 2009, between the registrant and Deerfield Private Design Fund, L.P. and Deerfield Private Design International, L.P.
|
|
10-K
|
|
001-16633
|
|
8/18/2009
|
4.3
|
|
Form of Warrant to purchase shares of the registrant's common stock issued to Deerfield Private Design Fund, L.P., Deerfield Private Design International, L.P., Deerfield Partners, L.P., Deerfield International Limited
|
|
8-K/A
|
|
001-16633
|
|
9/24/2009
|
4.4
|
|
Form of Amendment No. 1 to Warrant to purchase shares of the registrant's Common Stock issued to Deerfield Private Design Fund, L.P., Deerfield Private Design International, L.P., Deerfield Partners, L.P., Deerfield International Limited
|
|
8-K
|
|
001-16633
|
|
5/3/2011
|
4.5
|
|
Indenture dated June 10, 2013 by and between Array BioPharma Inc. and Wells Fargo Bank, National Association, as Trustee
|
|
8-K
|
|
001-16633
|
|
6/10/2013
|
4.6
|
|
First Supplemental Indenture dated June 10, 2013 by and between Array BioPharma Inc. and Wells Fargo Bank, National Association, as Trustee
|
|
8-K
|
|
001-16633
|
|
6/10/2013
|
4.7
|
|
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
|
|
9/23/2008
|
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
|
|
Amended and Restated Array BioPharma Inc. Employee Stock Purchase Plan*
|
|
DEF-14A
|
|
001-16633
|
|
9/14/2012
|
10.8
|
|
Employment Agreement, dated April 26, 2012, between registrant and Ron Squarer*
|
|
8-K
|
|
001-16633
|
|
5/1/2012
|
10.9
|
|
Noncompete Agreement, dated April 26, 2012, between registrant and Ron Squarer*
|
|
8-K
|
|
001-16633
|
|
5/1/2012
|
10.10
|
|
Confidentiality and Inventions Agreement, dated April 26, 2012, between registrant and Ron Squarer*
|
|
8-K
|
|
001-16633
|
|
5/1/2012
|
10.11
|
|
Form of Employment Agreement dated, September 1, 2002, between registrant and each of David L. Snitman and R. Michael Carruthers*
|
|
10-Q
|
|
001-16633
|
|
11/13/2002
|
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 March 18, 2013, between registrant and Michael Needle, M.D.*
|
|
10-Q
|
|
001-16633
|
|
5/7/2013
|
10.14
|
|
Noncompete Agreement, dated February 7, 2013, between registrant and Michael Needle*
|
|
10-Q
|
|
001-16633
|
|
5/7/2013
|
10.15
|
|
Confidentiality and Inventions Agreement, effective April 1, 2013, between registrant and Michael Needle*
|
|
10-Q
|
|
001-16633
|
|
5/7/2013
|
10.16
|
|
Amended and Restated Deferred Compensation Plan of Array BioPharma Inc., dated December 20, 2004*
|
|
8-K
|
|
001-16633
|
|
12/21/2004
|
|
|
|
|
Incorporated by Reference
|
||||
Exhibit Number
|
|
Description of Exhibit
|
|
Form
|
|
File No.
|
|
Date Filed
|
10.17
|
|
First Amendment to the Amended and Restated Deferred Compensation Plan of Array BioPharma Inc.*
|
|
10-Q
|
|
001-16633
|
|
2/6/2006
|
10.18
|
|
Research Services Agreement between registrant and Eli Lilly and Company, dated March 22, 2000, as amended**
|
|
S-1
|
|
333-45922
|
|
9/15/2000
|
10.19
|
|
Research Agreement between registrant and Amgen Inc., dated as of November 1, 2001**
|
|
8-K/A
|
|
001-16633
|
|
2/6/2002
|
10.20
|
|
Lead Generation Collaboration Agreement between registrant and Takeda Chemical Industries, Ltd., dated July 18, 2001**
|
|
10-Q
|
|
001-16633
|
|
11/14/2001
|
10.21
|
|
Collaboration and License Agreement between registrant and AstraZeneca AB, dated December 18, 2003**
|
|
10-Q
|
|
001-16633
|
|
2/2/2004
|
10.22
|
|
Drug Discovery Collaboration Agreement between registrant and Genentech, Inc., dated December 22, 2003**
|
|
10-Q
|
|
001-16633
|
|
2/2/2004
|
10.23
|
|
Second Amendment, dated October 1, 2005, to the Drug Discovery Collaboration Agreement between registrant and Genentech, Inc.**
|
|
10-Q
|
|
001-16633
|
|
2/6/2006
|
10.24
|
|
Letter Agreement dated, July 30, 2009, between the registrant and Genentech, Inc.**
|
|
10-Q
|
|
001-16633
|
|
11/2/2009
|
10.25
|
|
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
|
10.26
|
|
License Agreement, dated August 5, 2011, between the registrant and Genentech, Inc.**
|
|
10-Q
|
|
001-16633
|
|
11/2/2011
|
10.27
|
|
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
|
10.28
|
|
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
|
10.29
|
|
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
|
10.30
|
|
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
|
10.31
|
|
Drug Discovery Agreement between registrant and Ono Pharmaceutical Co., Ltd., dated November 1, 2005**
|
|
10-Q
|
|
001-16633
|
|
2/6/2006
|
10.32
|
|
Loan and Security agreement, dated June 28, 2005, by and between registrant and Comerica Bank
|
|
10-K
|
|
001-16633
|
|
9/13/2005
|
10.33
|
|
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
|
10.34
|
|
Second Amendment to Loan and Security Agreement, dated July 7, 2006, between the registrant and Comerica Bank
|
|
10-Q
|
|
001-16633
|
|
11/6/2006
|
10.35
|
|
Third Amendment to Loan and Security Agreement, dated June 12, 2008, between the registrant and Comerica Bank
|
|
10-K
|
|
001-16633
|
|
8/12/2010
|
10.36
|
|
Fourth Amendment to Loan and Security Agreement, dated March 11, 2009, between the registrant and Comerica Bank
|
|
10-K
|
|
001-16633
|
|
8/12/2010
|
10.37
|
|
Fifth Amendment to Loan and Security Agreement, dated September 30, 2009, between the registrant and Comerica Bank
|
|
8-K
|
|
001-16633
|
|
10/5/2009
|
10.38
|
|
Sixth Amendment to Loan and Security Agreement, dated March 31, 2010, between the registrant and Comerica Bank
|
|
8-K
|
|
001-16633
|
|
4/6/2010
|
10.39
|
|
Seventh Amendment to Loan and Security Agreement, dated June 11, 2011, between the registrant and Comerica Bank
|
|
10-K
|
|
001-16633
|
|
8/12/2011
|
10.40
|
|
Eighth Amendment to Loan and Security Agreement, dated December 28, 2012, between the registrant and Comerica Bank
|
|
10-Q
|
|
001-16633
|
|
2/6/2013
|
10.41
|
|
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
|
10.42
|
|
Tenth Amendment to Loan and Security Agreement, dated December 31, 2013, between the registrant and Comerica Bank
|
|
10-Q
|
|
001-16633
|
|
2/5/14
|
|
|
|
|
Incorporated by Reference
|
||||
Exhibit Number
|
|
Description of Exhibit
|
|
Form
|
|
File No.
|
|
Date Filed
|
10.43
|
|
Facilities Lease and Assignment, dated July 7, 2006, between the registrant and BMR-3200 Walnut Street LLC
|
|
10-Q
|
|
001-16633
|
|
11/6/2006
|
10.44
|
|
Facilities Lease and Assignment, dated August 9, 2006, between the registrant and BMR-Trade Center Avenue LLC
|
|
10-Q
|
|
001-16633
|
|
11/6/2006
|
10.45
|
|
Description of Performance Bonus Program*
|
|
8-K
|
|
001-16633
|
|
08/12/2013
|
10.46
|
|
License Agreement, dated April 19, 2010, between the registrant and Novartis International Pharmaceutical Ltd.**
|
|
10-K
|
|
001-16633
|
|
8/12/2010
|
10.47
|
|
Collaboration and License Agreement, dated July 12, 2011, between the registrant and ASLAN Pharmaceuticals**
|
|
10-Q
|
|
001-16633
|
|
11/2/2011
|
10.48
|
|
Sales Agreement, dated March 27, 2013, by and between registrant and Cantor Fitzgerald & Co.
|
|
8-K
|
|
001-16633
|
|
3/27/2013
|
10.49
|
|
Development and Commercialization Agreement, dated May 29, 2013, between registrant and Oncothyreon Inc.**
|
|
10-K
|
|
001-16633
|
|
8/12/2013
|
10.50
|
|
Drug Discovery and Collaboration Agreement, dated July 3, 2013, between registrant and Loxo Oncology, Inc.**
|
|
10-K
|
|
001-16633
|
|
8/12/2013
|
10.51
|
|
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
|
10.52
|
|
Amendment No. 1 to Drug Discovery Collaboration Agreement, dated November 26, 2013, by and between registrant and Loxo Oncology, Inc.***
|
|
|
|
Filed herewith
|
|
|
10.53
|
|
Amendment No. 2 to Drug Discovery Collaboration Agreement, dated April 10, 2014, by and between registrant and Loxo Oncology, Inc.***
|
|
|
|
Filed herewith
|
|
|
10.54
|
|
Employment Agreement, dated May 13, 2014, between registrant and Nicholas A. Saccomano, Ph.D.*
|
|
|
|
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
|
|
|
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
|
|
|
LOXO ONCOLOGY, INC.
|
|
ARRAY BIOPHARMA INC.
|
||
|
|
|
|
|
By:
|
/s/ Joshua H. Bilenker
|
|
By:
|
/s/ John Moore
|
|
|
|
|
|
Name:
|
Joshua H. Bilenker
|
|
Name:
|
John Moore
|
|
|
|
|
|
Title:
|
CEO
|
|
Title:
|
General Counsel
|
LOXO ONCOLOGY, INC.
|
|
ARRAY BIOPHARMA INC.
|
||
|
|
|
|
|
By:
|
/s/ Joshua H. Bilenker
|
|
By:
|
/s/ Mike Carruthers
|
|
|
|
|
|
Name:
|
Joshua H. Bilenker
|
|
Name:
|
Mike Carruthers
|
|
|
|
|
|
Title:
|
CEO
|
|
Title:
|
CFO
|
|
COMPANY:
|
||
|
|
|
|
|
ARRAY BIOPHARMA INC.
|
||
|
|
|
|
|
By:
|
/s/ Ron Squarer
|
|
|
Name:
|
Ron Squarer
|
|
|
Title:
|
Chief Executive Officer
|
|
|
|
|
|
|
EMPLOYEE:
|
||
|
|
|
|
|
/s/ Nicholas Saccomano
|
||
|
Nicholas Saccomano
|
|
|
|
|
|
|
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 14, 2014
|
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 14, 2014
|
By:
|
/s/ R. MICHAEL CARRUTHERS
|
|
|
|
R. Michael Carruthers
|
|
|
|
Chief Financial 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 14, 2014
|
/s/ RON SQUARER
|
|
|
Ron Squarer
|
|
|
Chief Executive Officer
|
|
|
|
|
|
|
|
|
/s/ R. MICHAEL CARRUTHERS
|
|
|
R. Michael Carruthers
|
|
|
Chief Financial Officer
|
|
|
(Principal Financial and Accounting Officer)
|