FORM 10-K
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ý
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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¨
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from to
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EXELIXIS, INC.
(Exact name of registrant as specified in its charter)
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Delaware
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04-3257395
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(State or other jurisdiction of incorporation or organization)
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(I.R.S. Employer Identification Number)
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Title of Each Class
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Name of Each Exchange on Which Registered
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Common Stock $.001 Par Value per Share
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The Nasdaq Stock Market LLC
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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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ITEM 1.
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BUSINESS
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Capitalizing on the Opportunity for the Potential Commercialization of Cabozantinib in Advanced RCC.
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Continuing to Execute Successfully on the COMETRIQ commercialization plan for MTC.
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Phase 2 or phase 1/2 clinical trials to help prioritize future pivotal trials of cabozantinib in disease settings where there is substantial unmet medical need and in which cabozantinib has previously demonstrated clinical activity, consisting of randomized phase 2 clinical trials in first line RCC (CABOSUN), ocular melanoma, prostate cancer and second/third line EGFR-wt NSCLC;
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Additional phase 2 or phase 1/2 clinical trials to explore cabozantinib’s potential utility in other tumor types, including endometrial cancer, bladder cancer, sarcomas, NSCLC (EGFR-activating mutation positive), differentiated thyroid cancer, triple-negative breast cancer, hormone-receptor-positive breast cancer, cutaneous melanoma (molecularly selected patients), pancreatic neuroendocrine and carcinoid tumors. Positive results in these indications could lead to further study in randomized phase 2 or phase 3 clinical trials; and
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Additional phase 1 clinical trials to further evaluate cabozantinib, consisting of a combination trial of cabozantinib and immune-oncology agents (nivolumab with or without ipilumumab) in genitourinary tumors, a trial to evaluate the safety and pharmacokinetics of cabozantinib in pediatric patients, and a trial of cabozantinib in patients with advanced solid tumors and human immunodeficiency virus.
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CABOSUN, the randomized phase 2 trial comparing cabozantinib to sunitinib in the treatment of intermediate or poor risk first-line RCC patients, which completed enrollment in early 2015 and is being conducted by The Alliance for Clinical Trials in Oncology;
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A phase 1b trial of cabozantinib plus nivolumab alone, or in combination with ipilimumab, in patients with genitourinary tumors, including bladder cancer and RCC; and
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A phase 2 trial evaluating single agent cabozantinib in recurrent endometrial cancer.
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A clinical study comparing a lower dose of COMETRIQ with the labeled dose of 140 mg. This study is evaluating safety and PFS in progressive, metastatic MTC patients.
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Submission of the OS analysis from the EXAM study (see above).
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Two clinical pharmacology studies assessing the pharmacokinetics of COMETRIQ, one to address the effect of administering COMETRIQ in conjunction with agents that increase gastric pH such as proton pump inhibitors, and the other study to assess the pharmacokinetics of COMETRIQ in patients with hepatic impairment. Both studies have been completed.
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Four non-clinical studies to further assess the carcinogenicity, mutagenicity and teratogenicity of COMETRIQ. The mutagenicity and teratogenicity studies and one of the two carcinogenicity studies have been completed.
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The combination of cobimetinib and vemuarfenib in additional melanoma patient populations and settings;
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A phase 2 trial of cobimetinib in combination with paclitaxel in triple negative breast cancer; and
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Phase 1 studies of cobimetinib in combination with atezolizumab in melanoma, NSCLC and colorectal cancer, in combination with MEHD7945A in KRAS mutant solid tumors including NSCLC and colorectal cancer and in combination with GDC-0994 in advanced metastatic solid tumors.
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preclinical laboratory and animal tests that must be conducted in accordance with Good Laboratory Practices;
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submission of an IND, which must become effective before clinical trials may begin;
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adequate and well-controlled human clinical trials to establish the safety and efficacy of the proposed drug candidate for its intended use;
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pre-approval inspection of manufacturing facilities and selected clinical investigators for their compliance with Good Manufacturing Practices, or GMP, and Good Clinical Practices, or GCP; and
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FDA approval of a NDA for commercial marketing, or of an NDA supplement, for approval of a new indication if the product is already approved for another indication.
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Phase 1 – Studies are initially conducted in a limited patient population to test the product candidate for safety, dosage tolerance, absorption, metabolism, distribution and excretion in healthy humans or patients.
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Phase 2 – Studies are conducted with groups of patients afflicted with a specified disease in order to provide enough data to evaluate the preliminary efficacy, optimal dosages and expanded evidence of safety. Multiple phase 2 clinical trials may be conducted by the sponsor to obtain information prior to beginning larger and more expensive phase 3 clinical trials. In some cases, a sponsor may decide to run what is referred to as a “phase 2b” evaluation, which is a second, confirmatory phase 2 trial that could, if positive, serve as a pivotal trial in the approval of a product candidate.
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Phase 3 – When phase 2 evaluations demonstrate that a dosage range of the product is effective and has an acceptable safety profile, phase 3 trials are undertaken in large patient populations to further evaluate dosage, to provide replicate statistically significant evidence of clinical efficacy and to further test for safety in an expanded patient population at multiple clinical trial sites.
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efficacy, safety and reliability of cabozantinib;
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timing and scope of regulatory approval;
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the speed at which we develop cabozantinib for the treatment of additional tumor types beyond progressive, metastatic MTC;
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our ability to complete preclinical testing and clinical development and obtain regulatory approvals for cabozantinib;
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our ability to manufacture and sell commercial quantities of cabozantinib to the market;
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our ability to successfully commercialize cabozantinib and secure coverage and adequate reimbursement in approved indications;
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product acceptance by physicians and other health care providers;
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skills of our employees and our ability to recruit and retain skilled employees;
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protection of our intellectual property; and
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the availability of substantial capital resources to fund development and commercialization activities.
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ITEM 1A.
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RISK FACTORS
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fund our operations and clinical trials;
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continue our research and development efforts;
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expand our sales, marketing and distribution capabilities;
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commercialize cabozantinib or any other future product candidates, if any such candidates receive regulatory approval for commercial sale; and
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fund the portion of U.S. sales and marketing costs for cobimetinib that we are obligated to fund under our collaboration with Genentech, or any similar costs we are obligated to fund under collaborations we may enter into in the future.
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the commercial success of COMETRIQ and the revenues we generate from that approved product;
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the pace and progress of our current increase in sales, marketing, medical affairs and distribution capabilities in anticipation of obtaining FDA approval for cabozantinib for the potential treatment of advanced RCC patients;
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the successful establishment of the distribution and commercialization network for COMETRIQ in the approved MTC indication and cabozantinib for the potential treatment of advanced RCC patients, as well as the achievement of stated regulatory and commercial milestones, under our collaboration with Ipsen;
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the commercial success of COTELLIC and the calculation of our share of related profits and losses for the commercialization of COTELLIC in the U.S. and royalties from COTELLIC sales outside the U.S. under our collaboration with Genentech;
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the speed of a potential regulatory approval for cabozantinib for the treatment of advanced RCC and other indications;
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future clinical trial results, notably the results from CELESTIAL, our phase 3 pivotal trial in patients with advanced HCC;
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repayment of the Deerfield Notes (see “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations - Certain Factors Important to Understanding Our Financial Condition and Results of Operations - Deerfield Facility” for a description of these notes) which mature on July 1, 2018, subject to a requirement to make a mandatory prepayment in each of 2017 and 2018 equal to 15% of certain revenues from collaborative arrangements (other than intercompany arrangements) received during the prior fiscal year, subject to a maximum annual prepayment amount of $27.5 million;
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our ability to repay the Deerfield Notes with our common stock, which we are only able to do under specified conditions;
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repayment of our $287.5 million aggregate principal amount of the 4.25% Convertible Senior Subordinated Notes due 2019, or the 2019 Notes, (see “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations - Certain Factors Important to Understanding Our Financial Condition and Results of Operations - Convertible Senior Subordinated Notes” for a description of these notes), which mature on August 15, 2019, unless earlier converted, redeemed or repurchased;
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repayment of our term loan from Silicon Valley Bank, which had an outstanding balance at
December 31, 2015
, of
$80.0 million
;
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our ability to control costs;
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our ability to remain in compliance with, or amend or cause to be waived, financial covenants contained in agreements with third parties;
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the cost of clinical drug supply for our clinical trials;
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trends and developments in the pricing of oncologic therapeutics in the United States and abroad, especially in the EU;
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scientific developments in the market for oncologic therapeutics and the timing of regulatory approvals for competing oncologic therapies; and
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the filing, maintenance, prosecution, defense and enforcement of patent claims and other intellectual property rights.
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making it more difficult for us to meet our payment and other obligations under the 2019 Notes, the Deerfield Notes, our loan and security agreement with Silicon Valley Bank or our other indebtedness;
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resulting in an event of default if we fail to comply with the covenants contained in our debt agreements, which event of default could result in all of our debt becoming immediately due and payable;
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increasing our vulnerability to adverse economic and industry conditions;
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subjecting us to the risk of increased sensitivity to interest rate increases on our indebtedness with variable interest rates, including borrowings under our loan and security agreement with Silicon Valley Bank;
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limiting our ability to obtain additional financing;
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requiring the dedication of a substantial portion of our cash flow from operations to service our indebtedness, thereby reducing the amount of our cash flow available for other purposes, including clinical trials, research and development, capital expenditures, working capital and other general corporate purposes;
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limiting our flexibility in planning for, or reacting to, changes in our business;
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preventing us from raising funds necessary to purchase the 2019 Notes in the event we are required to do so following a “Fundamental Change” as specified in the indenture governing the 2019 Notes, or to settle conversions of the 2019 Notes in cash;
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dilution experienced by our existing stockholders as a result of the conversion of the 2019 Notes or the Deerfield Notes into shares of common stock; and
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placing us at a possible competitive disadvantage with less leveraged competitors and competitors that may have better access to capital resources.
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the effectiveness, or perceived effectiveness, of cabozantinib in comparison to competing products;
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the existence of any significant side effects of cabozantinib, as well as their severity in comparison to those of any competing products;
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cabozantinib’s potential advantages or disadvantages in relation to alternative treatments;
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the timing of market entry relative to competitive treatments;
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indications for which cabozantinib is approved;
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the ability to offer cabozantinib for sale at competitive prices;
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relative convenience and ease of administration;
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the strength of sales, marketing, medical affairs and distribution support; and
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sufficient third-party coverage and reimbursement.
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the federal Anti-Kickback Law, which constrains our business activities, including our marketing practices, educational programs, pricing policies, and relationships with healthcare providers or other entities, by prohibiting, among other things, persons and entities from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual for, or the purchase, order or recommendation of, any good or service for which payment may be made under federal healthcare programs such as the Medicare and Medicaid programs;
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federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payers that are false or fraudulent;
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federal criminal laws that prohibit executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters;
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HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, and their implementing regulations, which impose certain requirements relating to the privacy, security and transmission of individually identifiable health information;
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state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payer, including commercial insurers, and state laws
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the Foreign Corrupt Practices Act, a U.S. law which regulates certain financial relationships with foreign government officials (which could include, for example, certain medical professionals);
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federal and state consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers;
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state and federal government price reporting laws that require us to calculate and report complex pricing metrics to government programs, where such reported priced may be used in the calculation of reimbursement and/or discounts on our marketed drugs (participation in these programs and compliance with the applicable requirements may subject us to potentially significant discounts on our products, increased infrastructure costs, and potentially limit our ability to offer certain marketplace discounts); and
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state and federal marketing expenditure tracking and reporting laws, which generally require certain types of expenditures in the United States to be tracked and reported (compliance with such requirements may require investment in infrastructure to ensure that tracking is performed properly, and some of these laws result in the public disclosure of various types of payments and relationships, which could potentially have a negative effect on our business and/or increase enforcement scrutiny of our activities).
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cabozantinib may not prove to be efficacious or may cause, or potentially cause, harmful side effects;
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negative or inconclusive clinical trial results may require us to conduct further testing or to abandon projects that we had expected to be promising;
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our competitors may discover or commercialize other compounds or therapies that show significantly improved safety or efficacy compared to cabozantinib;
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patient registration or enrollment in our clinical testing may be lower than we anticipate, resulting in the delay or cancellation of clinical testing; and
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regulators or institutional review boards may withhold authorization of cabozantinib, or delay, suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements or their determination that participating patients are being exposed to unacceptable health risks.
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the number of patients who ultimately participate in the clinical trial;
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the duration of patient follow-up that is appropriate in view of the results or required by regulatory authorities;
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the number of clinical sites included in the trials; and
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the length of time required to enroll suitable patient subjects.
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we are not able to control the amount and timing of resources that our collaborators or potential future collaborators will devote to the development or commercialization of drug candidates or to their marketing and distribution;
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we are not able to control the U.S. commercial resourcing decisions made and resulting costs incurred by Genentech for cobimetinib, which reasonable costs we are obligated to share, in part, under our collaboration agreement with Genentech;
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collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a drug candidate, repeat or conduct new clinical trials or require a new formulation of a drug candidate for clinical testing;
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disputes may arise between us and our collaborators that result in the delay or termination of the research, development or commercialization of our drug candidates, or that diminish or delay receipt of the economic benefits we are entitled to receive under the collaboration, or that result in costly litigation or arbitration that diverts management’s attention and resources;
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collaborators may experience financial difficulties;
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collaborators may not be successful in their efforts to obtain regulatory approvals in a timely manner, or at all;
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collaborators may not properly maintain or defend our intellectual property rights or may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our proprietary information or expose us to potential litigation;
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collaborators may not comply with applicable healthcare regulatory laws;
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business combinations or significant changes in a collaborator’s business strategy may adversely affect a collaborator’s willingness or ability to complete its obligations under any arrangement;
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a collaborator could independently move forward with a competing drug candidate developed either independently or in collaboration with others, including our competitors;
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we may be precluded from entering into additional collaboration arrangements with other parties in an area or field of exclusivity;
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future collaborators may require us to relinquish some important rights, such as marketing and distribution rights; and
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collaborations may be terminated or allowed to expire, which would delay, and may increase the cost of development of our drug candidates.
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the pace and progress of our current increase in sales, marketing, medical affairs and distribution capabilities in anticipation of obtaining FDA approval for cabozantinib for the potential treatment of advanced RCC patients;
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the commercial success of COMETRIQ and the revenues we generate;
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the successful establishment of the distribution and commercialization network for COMETRIQ in the approved MTC indication and cabozantinib for the potential treatment of advanced RCC patients, as well as the achievement of stated development and commercial milestones, under our collaboration with Ipsen;
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the progress and scope of other development and commercialization activities for cabozantinib and our other compounds;
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future clinical trial results, notably the results from CELESTIAL, our phase 3 pivotal trial in patients with advanced HCC;
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the inability to obtain adequate product supply for any approved drug product or inability to do so at acceptable prices;
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recognition of upfront licensing or other fees or revenues;
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payments of non-refundable upfront or licensing fees, or payment for cost-sharing expenses, to third parties;
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the success rate of our efforts leading to milestone payments and royalties;
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the introduction of new technologies or products by our competitors;
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the timing and willingness of collaborators to further develop or, if approved, commercialize our product candidates out-licensed to them;
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the termination or non-renewal of existing collaborations or third party vendor relationships;
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regulatory actions with respect to our product candidates and any approved products or our competitors’ products;
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disputes or other developments relating to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our technologies;
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the timing and amount of expenses incurred for clinical development and manufacturing of cabozantinib;
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adjustments to expenses accrued in prior periods based on management’s estimates after the actual level of activity relating to such expenses becomes more certain;
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the impairment of acquired goodwill and other assets;
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the impact of our restructuring activities;
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additions and departures of key personnel;
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general and industry-specific economic conditions that may affect our or our collaborators’ research and development expenditures; and
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other factors described in this “Risk Factors” section
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adverse results or delays in our or our collaborators’ clinical trials;
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announcement of FDA approval or non-approval, or delays in the FDA review process, of cabozantinib or our collaborators’ product candidates or those of our competitors or actions taken by regulatory agencies with respect to our, our collaborators’ or our competitors’ clinical trials;
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the commercial success of COMETRIQ and the revenues we generate;
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the timing of achievement of our clinical, regulatory, partnering and other milestones, such as the commencement of clinical development, the completion of a clinical trial, the filing for regulatory approval or the establishment of collaborative arrangements for cabozantinib or any of our other programs or compounds;
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actions taken by regulatory agencies with respect to cabozantinib or our clinical trials for cabozantinib;
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the announcement of new products by our competitors;
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quarterly variations in our or our competitors’ results of operations;
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developments in our relationships with our collaborators, including the termination or modification of our agreements;
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conflicts or litigation with our collaborators;
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litigation, including intellectual property infringement and product liability lawsuits, involving us;
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failure to achieve operating results projected by securities analysts;
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changes in earnings estimates or recommendations by securities analysts;
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financing transactions;
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developments in the biotechnology, biopharmaceutical or pharmaceutical industry;
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sales of large blocks of our common stock or sales of our common stock by our executive officers, directors and significant stockholders;
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departures of key personnel or board members;
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FDA or international regulatory actions;
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third-party coverage and reimbursement policies;
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disposition of any of our technologies or compounds; and
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general market, economic and political conditions and other factors, including factors unrelated to our operating performance or the operating performance of our competitors.
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a classified Board of Directors;
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a prohibition on actions by our stockholders by written consent;
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the inability of our stockholders to call special meetings of stockholders;
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the ability of our Board of Directors to issue preferred stock without stockholder approval, which could be used to institute a “poison pill” that would work to dilute the stock ownership of a potential hostile acquirer, effectively preventing acquisitions that have not been approved by our Board of Directors;
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limitations on the removal of directors; and
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advance notice requirements for director nominations and stockholder proposals.
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ITEM 1B.
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UNRESOLVED STAFF COMMENTS
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ITEM 2.
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PROPERTIES
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The first two leases cover two buildings for a total of 130,964 square feet and expire in 2017, with two five-year options to extend their respective terms prior to expiration. We have subleased a total of 107,594 square feet of portions of these buildings to five different subtenants. The terms of the subleases expire at the end of our lease terms.
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The third lease covers two buildings for a total of 116,063 square feet and expires in 2018.
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ITEM 3.
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LEGAL PROCEEDINGS
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ITEM 4.
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MINE SAFETY DISCLOSURES
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ITEM 5.
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MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES
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Common Stock Price
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||||||
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High
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Low
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Year ended January 1, 2016:
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Quarter ended April 3, 2015
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$
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3.16
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$
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1.54
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Quarter ended July 3, 2015
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$
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4.18
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$
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2.51
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Quarter ended October 2, 2015
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$
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6.81
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$
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3.31
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Quarter ended January 1, 2016
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$
|
6.42
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|
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$
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4.70
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Year ended January 2, 2015:
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||||
Quarter ended March 28, 2014
|
$
|
8.41
|
|
|
$
|
3.37
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|
Quarter ended June 27, 2014
|
$
|
3.84
|
|
|
$
|
3.02
|
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Quarter ended September 26, 2014
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$
|
4.55
|
|
|
$
|
1.51
|
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Quarter ended January 2, 2015
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$
|
1.88
|
|
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$
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1.26
|
|
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December 31,
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||||||||||||||||
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2010
|
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2011
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2012
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2013
|
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2014
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2015
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||||||
Exelixis, Inc.
|
100
|
|
|
58
|
|
|
55
|
|
|
72
|
|
|
20
|
|
|
69
|
|
NASDAQ Market Index
|
100
|
|
|
98
|
|
|
112
|
|
|
157
|
|
|
178
|
|
|
189
|
|
NASDAQ Biotechnology Index
|
100
|
|
|
112
|
|
|
145
|
|
|
243
|
|
|
330
|
|
|
365
|
|
ITEM 6.
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SELECTED FINANCIAL DATA
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|
Year Ended December 31,
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||||||||||||||||||
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2015
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2014
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2013
|
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2012
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2011
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(In thousands, except per share data)
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Consolidated Statements of Operations Data:
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||||||||||
Revenues
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$
|
37,172
|
|
|
$
|
25,111
|
|
|
$
|
31,338
|
|
|
$
|
47,450
|
|
|
$
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289,636
|
|
Operating expenses:
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|
|
|
|
|
|
|
|
|
||||||||||
Cost of goods sold
|
3,895
|
|
|
2,043
|
|
|
1,118
|
|
|
—
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|
|
—
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|
|||||
Research and development
|
96,351
|
|
|
189,101
|
|
|
178,763
|
|
|
128,878
|
|
|
156,836
|
|
|||||
Selling, general and administrative
|
57,305
|
|
|
50,829
|
|
|
50,958
|
|
|
31,837
|
|
|
33,129
|
|
|||||
Restructuring charge
|
1,042
|
|
|
7,596
|
|
|
1,231
|
|
|
9,171
|
|
|
10,136
|
|
|||||
Total operating expenses
|
158,593
|
|
|
249,569
|
|
|
232,070
|
|
|
169,886
|
|
|
200,101
|
|
|||||
(Loss) income from operations
|
(121,421
|
)
|
|
(224,458
|
)
|
|
(200,732
|
)
|
|
(122,436
|
)
|
|
89,535
|
|
|||||
Other income (expense), net
|
(48,261
|
)
|
|
(44,266
|
)
|
|
(44,124
|
)
|
|
(25,102
|
)
|
|
(12,543
|
)
|
|||||
(Loss) income before taxes
|
(169,682
|
)
|
|
(268,724
|
)
|
|
(244,856
|
)
|
|
(147,538
|
)
|
|
76,992
|
|
|||||
Income tax provision (benefit)
|
55
|
|
|
(182
|
)
|
|
(96
|
)
|
|
107
|
|
|
1,295
|
|
|||||
Net (loss) income
|
$
|
(169,737
|
)
|
|
$
|
(268,542
|
)
|
|
$
|
(244,760
|
)
|
|
$
|
(147,645
|
)
|
|
$
|
75,697
|
|
Net loss per share, basic
|
$
|
(0.81
|
)
|
|
$
|
(1.38
|
)
|
|
$
|
(1.33
|
)
|
|
$
|
(0.92
|
)
|
|
$
|
0.60
|
|
Net loss per share, diluted
|
$
|
(0.81
|
)
|
|
$
|
(1.38
|
)
|
|
$
|
(1.33
|
)
|
|
$
|
(0.92
|
)
|
|
$
|
0.58
|
|
Shares used in computing basic loss per share amounts
|
209,227
|
|
|
194,299
|
|
|
184,062
|
|
|
160,138
|
|
|
126,018
|
|
|||||
Shares used in computing diluted loss per share amounts
|
209,227
|
|
|
194,299
|
|
|
184,062
|
|
|
160,138
|
|
|
130,479
|
|
|
December 31,
|
||||||||||||||||||
|
2015
|
|
2014
|
|
2013
|
|
2012
|
|
2011
|
||||||||||
|
(In thousands)
|
||||||||||||||||||
Consolidated Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
||||||||||
Cash and investments
|
$
|
253,310
|
|
|
$
|
242,760
|
|
|
$
|
415,862
|
|
|
$
|
633,961
|
|
|
$
|
283,720
|
|
Working (deficit) capital
(1)
|
$
|
126,414
|
|
|
$
|
(3,188
|
)
|
|
$
|
178,756
|
|
|
$
|
350,837
|
|
|
$
|
136,500
|
|
Total assets
(1)
|
$
|
332,342
|
|
|
$
|
323,269
|
|
|
$
|
497,951
|
|
|
$
|
714,142
|
|
|
$
|
391,862
|
|
Long-term obligations
(1)
|
$
|
384,395
|
|
|
$
|
267,669
|
|
|
$
|
343,860
|
|
|
$
|
336,004
|
|
|
$
|
192,583
|
|
Accumulated deficit
|
$
|
(1,937,041
|
)
|
|
$
|
(1,767,304
|
)
|
|
$
|
(1,498,762
|
)
|
|
$
|
(1,254,002
|
)
|
|
$
|
(1,106,357
|
)
|
Total stockholders’ (deficit) equity
|
$
|
(104,304
|
)
|
|
$
|
(114,829
|
)
|
|
$
|
66,238
|
|
|
$
|
296,434
|
|
|
$
|
90,632
|
|
(1)
|
Prior periods have been adjusted to reflect the early adoption of Accounting Standards Update No. 2015-03 “Simplifying the Presentation of Debt Issuance Costs,” or ASU 2015-03. See “Note 1. Organization and Summary of Significant Accounting Policies” of the Notes to Consolidated Financial Statements for a further description of the early adoption of ASU 2015-03.
|
ITEM 7.
|
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
|
•
|
The combination of cobimetinib and vemuarfenib in additional melanoma patient populations and settings;
|
•
|
A phase 2 trial of cobimetinib in combination with paclitaxel in triple negative breast cancer; and
|
•
|
Phase 1 studies of cobimetinib in combination with atezolizumab in melanoma, non-small cell lung cancer, or NSCLC, and colorectal cancer, in combination with MEHD7945A in KRAS mutant solid tumors including NSCLC and colorectal cancer and in combination with GDC-0994 in advanced metastatic solid tumors.
|
|
Year Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Stated coupon interest
|
$
|
6,792
|
|
|
$
|
6,000
|
|
|
$
|
6,000
|
|
Amortization of debt discount and debt issuance costs
|
9,278
|
|
|
11,731
|
|
|
10,089
|
|
|||
Total interest expense
|
$
|
16,070
|
|
|
$
|
17,731
|
|
|
$
|
16,089
|
|
|
Year Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Gross product revenues
|
$
|
36,650
|
|
|
$
|
28,963
|
|
|
$
|
15,702
|
|
Discounts and allowances
|
(2,492
|
)
|
|
(3,852
|
)
|
|
(685
|
)
|
|||
Net product revenues
|
34,158
|
|
|
25,111
|
|
|
15,017
|
|
|||
License revenues
(1)
|
14
|
|
|
—
|
|
|
8,380
|
|
|||
Contract revenues
(2)
|
3,000
|
|
|
—
|
|
|
7,941
|
|
|||
Total revenues
|
$
|
37,172
|
|
|
$
|
25,111
|
|
|
$
|
31,338
|
|
Dollar change
|
$
|
12,061
|
|
|
$
|
(6,227
|
)
|
|
|
||
Percentage change
|
48
|
%
|
|
(20
|
)%
|
|
|
(1)
|
Includes royalties and amortization of upfront payments.
|
(2)
|
Includes contingent and milestone payments.
|
|
Year Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Diplomat Specialty Pharmacy
|
$
|
30,856
|
|
|
$
|
24,832
|
|
|
$
|
14,004
|
|
Swedish Orphan Biovitrum
(1)
|
3,303
|
|
|
279
|
|
|
1,013
|
|
|||
Merck
|
3,000
|
|
|
—
|
|
|
—
|
|
|||
Bristol-Myers Squibb
|
—
|
|
|
—
|
|
|
16,321
|
|
|||
Other
|
13
|
|
|
—
|
|
|
—
|
|
|||
Total revenues
|
$
|
37,172
|
|
|
$
|
25,111
|
|
|
$
|
31,338
|
|
Dollar change
|
$
|
12,061
|
|
|
$
|
(6,227
|
)
|
|
|
||
Percentage change
|
48
|
%
|
|
(20
|
)%
|
|
|
(1)
|
Revenues from Swedish Orphan Biovitrum for the years ended
December 31, 2015
and
2014
included a
$0.1 million
and
$2.3 million
reduction, respectively, to revenue for a project management fee payable to our European distributor upon their achievement of a cumulative revenue goal.
$0.7 million
of the
$2.3 million
we recorded during 2014 represented amounts that would have been recorded in 2013 had the cumulative revenue goal been determined to be probable in that period.
|
|
Year Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Research and development expenses
|
$
|
96,351
|
|
|
$
|
189,101
|
|
|
$
|
178,763
|
|
Dollar change
|
$
|
(92,750
|
)
|
|
$
|
10,338
|
|
|
|
||
Percentage change
|
(49
|
)%
|
|
6
|
%
|
|
|
|
Year Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Selling, general and administrative expenses
|
$
|
57,305
|
|
|
$
|
50,829
|
|
|
$
|
50,958
|
|
Dollar change
|
$
|
6,476
|
|
|
$
|
(129
|
)
|
|
|
||
Percentage change
|
13
|
%
|
|
—
|
%
|
|
|
|
Year Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Restructuring charge
|
$
|
1,042
|
|
|
$
|
7,596
|
|
|
$
|
1,231
|
|
Dollar change
|
$
|
(6,554
|
)
|
|
$
|
6,365
|
|
|
|
||
Percentage change
|
(86
|
)%
|
|
517
|
%
|
|
|
|
Year Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Interest income and other, net
|
$
|
412
|
|
|
$
|
4,341
|
|
|
$
|
1,223
|
|
Interest expense
|
(48,673
|
)
|
|
(48,607
|
)
|
|
(45,347
|
)
|
|||
Total other income (expense), net
|
$
|
(48,261
|
)
|
|
$
|
(44,266
|
)
|
|
$
|
(44,124
|
)
|
Dollar change
|
$
|
(3,995
|
)
|
|
$
|
(142
|
)
|
|
|
||
Percentage change
|
9
|
%
|
|
—
|
%
|
|
|
|
Year Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Net loss
|
$
|
(169,737
|
)
|
|
$
|
(268,542
|
)
|
|
$
|
(244,760
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities
|
53,997
|
|
|
43,414
|
|
|
48,255
|
|
|||
Changes in operating assets and liabilities
|
(25,845
|
)
|
|
(10,277
|
)
|
|
(2,268
|
)
|
|||
Net cash used in operating activities
|
(141,585
|
)
|
|
(235,405
|
)
|
|
(198,773
|
)
|
|||
Net cash provided by investing activities
|
50,077
|
|
|
146,330
|
|
|
144,351
|
|
|||
Net cash provided by (used in) financing activities
|
152,747
|
|
|
65,492
|
|
|
(11,669
|
)
|
|||
Net increase (decrease) in cash and cash equivalents
|
61,239
|
|
|
(23,583
|
)
|
|
(66,091
|
)
|
|||
Cash and cash equivalents at beginning of year
|
80,395
|
|
|
103,978
|
|
|
170,069
|
|
|||
Cash and cash equivalents at end of year
|
$
|
141,634
|
|
|
$
|
80,395
|
|
|
$
|
103,978
|
|
•
|
the commercial success of COMETRIQ and the revenues we generate from that approved product;
|
•
|
the pace and progress of our current increase in sales, marketing, medical affairs and distribution capabilities in anticipation of obtaining FDA approval for cabozantinib for the potential treatment of advanced RCC patients;
|
•
|
the successful establishment of the distribution and commercialization network for COMETRIQ in the approved MTC indication and cabozantinib for the potential treatment of advanced RCC patients, as well as the achievement of stated regulatory and commercial milestones, under our collaboration with Ipsen;
|
•
|
the commercial success of COTELLIC and the calculation of our share of related profits and losses for the commercialization of COTELLIC in the U.S. and royalties from COTELLIC sales outside the U.S. under our collaboration with Genentech;
|
•
|
the speed of a potential regulatory approval for cabozantinib for the treatment of advanced RCC and other indications;
|
•
|
future clinical trial results, notably the results from CELESTIAL, our phase 3 pivotal trial in patients with advanced HCC;
|
•
|
repayment of the Deerfield Notes which mature on July 1, 2018, subject to a requirement to make a mandatory prepayment in each of 2017 and 2018 equal to 15% of certain revenues from collaborative arrangements (other than intercompany arrangements) received during the prior fiscal year, subject to a maximum annual prepayment amount of $27.5 million;
|
•
|
our ability to repay the Deerfield Notes with our common stock, which we are only able to do under specified conditions;
|
•
|
repayment of our $287.5 million aggregate principal amount of the 2019 Notes, which mature on August 15, 2019, unless earlier converted, redeemed or repurchased;
|
•
|
repayment of our term loan from Silicon Valley Bank, which had an outstanding balance at
December 31, 2015
, of
$80.0 million
;
|
•
|
our ability to control costs;
|
•
|
our ability to remain in compliance with, or amend or cause to be waived, financial covenants contained in agreements with third parties;
|
•
|
the cost of clinical drug supply for our clinical trials;
|
•
|
trends and developments in the pricing of oncologic therapeutics in the United States and abroad, especially in the EU;
|
•
|
scientific developments in the market for oncologic therapeutics and the timing of regulatory approvals for competing oncologic therapies; and
|
•
|
the filing, maintenance, prosecution, defense and enforcement of patent claims and other intellectual property rights.
|
|
|
Payments Due by Period
|
||||||||||||||
Contractual Obligations
|
|
Total
|
|
Less than
1 year
|
|
1-3
Years
|
|
More than 3
years
|
||||||||
Convertible notes
(1)
|
|
$
|
412,472
|
|
|
$
|
—
|
|
|
$
|
412,472
|
|
|
$
|
—
|
|
Loans payable
(2)
|
|
80,000
|
|
|
—
|
|
|
80,000
|
|
|
—
|
|
||||
Operating leases
(3)
|
|
25,717
|
|
|
14,236
|
|
|
11,481
|
|
|
—
|
|
||||
Purchase obligations
(4)
|
|
907
|
|
|
907
|
|
|
—
|
|
|
—
|
|
||||
Other long-term liabilities
|
|
106
|
|
|
—
|
|
|
106
|
|
|
—
|
|
||||
Total contractual cash obligations
|
|
$
|
519,202
|
|
|
$
|
15,143
|
|
|
$
|
504,059
|
|
|
$
|
—
|
|
(1)
|
Includes our obligations under the Deerfield Notes and the 2019 Notes. See “---Certain Factors Important to Understanding Our Financial Condition and Results of Operations” and “Note 7 - Debt” of the Notes to Consolidated Financial Statements regarding the terms of the Deerfield Notes and the 2019 Notes.
|
(2)
|
Includes our obligations under our loan from Silicon Valley Bank. See “---Certain Factors Important to Understanding Our Financial Condition and Results of Operations” and “Note 7 - Debt” of the Notes to Consolidated Financial Statements regarding the terms of our loan from Silicon Valley Bank.
|
(3)
|
The operating lease payments do not include
$6.1 million
to be received through 2017 in connection with the subleases for three of our South San Francisco buildings.
|
(4)
|
At December 31, 2015, we had firm purchase commitments related to manufacturing and maintenance of inventory. These commitments include a portion of our 2015 contractual minimum purchase obligation. Our actual purchases are expected to significantly exceed these amounts.
|
|
December 31, 2015
|
|
December 31, 2014
|
||||||||||||||
|
Prior to
Adoption of ASU 2015-03 |
|
ASU 2015-03
Adjustment |
|
As Adopted
|
|
Prior to
Adoption of ASU 2015-03 (as previously reported) |
|
ASU 2015-03
Adjustment |
|
As Adopted
|
||||||
Other long-term assets
|
5,579
|
|
|
(3,270
|
)
|
|
2,309
|
|
|
8,340
|
|
|
(4,691
|
)
|
|
3,649
|
|
Total assets
|
335,612
|
|
|
(3,270
|
)
|
|
332,342
|
|
|
327,960
|
|
|
(4,691
|
)
|
|
323,269
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Current portion of convertible notes
|
—
|
|
|
—
|
|
|
—
|
|
|
98,880
|
|
|
(1,431
|
)
|
|
97,449
|
|
Current liabilities
|
52,251
|
|
|
—
|
|
|
52,251
|
|
|
171,860
|
|
|
(1,431
|
)
|
|
170,429
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Long-term portion of convertible notes
|
304,705
|
|
|
(3,270
|
)
|
|
301,435
|
|
|
182,395
|
|
|
(3,260
|
)
|
|
179,135
|
|
Total liabilities
|
439,916
|
|
|
(3,270
|
)
|
|
436,646
|
|
|
442,789
|
|
|
(4,691
|
)
|
|
438,098
|
|
ITEM 7A.
|
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
|
ITEM 8.
|
FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
|
|
Page
|
|
December 31,
|
||||||
|
2015
|
|
2014
|
||||
ASSETS
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
141,634
|
|
|
$
|
80,395
|
|
Short-term investments
|
25,426
|
|
|
63,890
|
|
||
Short-term restricted cash and investments
|
—
|
|
|
12,212
|
|
||
Trade and other receivables
|
5,183
|
|
|
4,882
|
|
||
Inventory
|
2,616
|
|
|
2,381
|
|
||
Prepaid expenses and other current assets
|
3,806
|
|
|
3,481
|
|
||
Total current assets
|
178,665
|
|
|
167,241
|
|
||
Long-term investments
|
83,600
|
|
|
81,579
|
|
||
Long-term restricted cash and investments
|
2,650
|
|
|
4,684
|
|
||
Property and equipment, net
|
1,434
|
|
|
2,432
|
|
||
Goodwill
|
63,684
|
|
|
63,684
|
|
||
Other long-term assets
|
2,309
|
|
|
3,649
|
|
||
Total assets
|
$
|
332,342
|
|
|
$
|
323,269
|
|
LIABILITIES AND STOCKHOLDERS’ DEFICIT
|
|
|
|
||||
Current liabilities:
|
|
|
|
||||
Accounts payable
|
$
|
6,401
|
|
|
$
|
6,413
|
|
Accrued clinical trial liabilities
|
18,071
|
|
|
41,545
|
|
||
Accrued collaboration liability
|
10,938
|
|
|
732
|
|
||
Accrued compensation and benefits
|
3,629
|
|
|
3,350
|
|
||
Other accrued liabilities
|
10,007
|
|
|
11,550
|
|
||
Current portion of restructuring
|
3,205
|
|
|
6,426
|
|
||
Current portion of convertible notes
|
—
|
|
|
97,449
|
|
||
Current portion of loans payable
|
—
|
|
|
381
|
|
||
Deferred revenue
|
—
|
|
|
2,583
|
|
||
Total current liabilities
|
52,251
|
|
|
170,429
|
|
||
Long-term portion of convertible notes
|
301,435
|
|
|
179,135
|
|
||
Long-term portion of loans payable
|
80,000
|
|
|
80,000
|
|
||
Long-term portion of restructuring
|
1,385
|
|
|
4,365
|
|
||
Other long-term liabilities
|
1,575
|
|
|
4,169
|
|
||
Total liabilities
|
436,646
|
|
|
438,098
|
|
||
Commitments (Note 13)
|
|
|
|
||||
Stockholders’ deficit:
|
|
|
|
||||
Preferred stock, $0.001 par value, 10,000,000 shares authorized and no shares issued
|
—
|
|
|
—
|
|
||
Common stock, $0.001 par value; 400,000,000 shares authorized; issued and outstanding:
227,960,943 and 195,895,769 shares at December 31, 2015 and 2014,
respectively
|
228
|
|
|
196
|
|
||
Additional paid-in capital
|
1,832,741
|
|
|
1,652,400
|
|
||
Accumulated other comprehensive loss
|
(232
|
)
|
|
(121
|
)
|
||
Accumulated deficit
|
(1,937,041
|
)
|
|
(1,767,304
|
)
|
||
Total stockholders’ deficit
|
(104,304
|
)
|
|
(114,829
|
)
|
||
Total liabilities and stockholders’ deficit
|
$
|
332,342
|
|
|
$
|
323,269
|
|
|
Year Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Revenues:
|
|
|
|
|
|
||||||
Net product revenues
|
$
|
34,158
|
|
|
$
|
25,111
|
|
|
$
|
15,017
|
|
License and contract revenues
|
3,014
|
|
|
—
|
|
|
16,321
|
|
|||
Total revenues
|
37,172
|
|
|
25,111
|
|
|
31,338
|
|
|||
Operating expenses:
|
|
|
|
|
|
||||||
Cost of goods sold
|
3,895
|
|
|
2,043
|
|
|
1,118
|
|
|||
Research and development
|
96,351
|
|
|
189,101
|
|
|
178,763
|
|
|||
Selling, general and administrative
|
57,305
|
|
|
50,829
|
|
|
50,958
|
|
|||
Restructuring charges
|
1,042
|
|
|
7,596
|
|
|
1,231
|
|
|||
Total operating expenses
|
158,593
|
|
|
249,569
|
|
|
232,070
|
|
|||
Loss from operations
|
(121,421
|
)
|
|
(224,458
|
)
|
|
(200,732
|
)
|
|||
Other income (expense), net:
|
|
|
|
|
|
||||||
Interest income and other, net
|
412
|
|
|
4,341
|
|
|
1,223
|
|
|||
Interest expense
|
(48,673
|
)
|
|
(48,607
|
)
|
|
(45,347
|
)
|
|||
Total other income (expense), net
|
(48,261
|
)
|
|
(44,266
|
)
|
|
(44,124
|
)
|
|||
Loss before income taxes
|
(169,682
|
)
|
|
(268,724
|
)
|
|
(244,856
|
)
|
|||
Income tax provision (benefit)
|
55
|
|
|
(182
|
)
|
|
(96
|
)
|
|||
Net loss
|
$
|
(169,737
|
)
|
|
$
|
(268,542
|
)
|
|
$
|
(244,760
|
)
|
Net loss per share, basic and diluted
|
$
|
(0.81
|
)
|
|
$
|
(1.38
|
)
|
|
$
|
(1.33
|
)
|
Shares used in computing basic and diluted net loss per share amounts
|
209,227
|
|
|
194,299
|
|
|
184,062
|
|
|
Year Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Net loss
|
$
|
(169,737
|
)
|
|
$
|
(268,542
|
)
|
|
$
|
(244,760
|
)
|
Other comprehensive (loss) income, net of tax of $0, $0 and $106 (1)
|
(111
|
)
|
|
(267
|
)
|
|
238
|
|
|||
Comprehensive loss
|
$
|
(169,848
|
)
|
|
$
|
(268,809
|
)
|
|
$
|
(244,522
|
)
|
(1)
|
Other comprehensive (loss) income consisted solely of unrealized losses or gains, net on available for sale securities arising during the periods presented. There were no reclassification adjustments to net loss resulting from realized losses or gains on the sale of securities.
|
|
Common
Stock
Shares
|
|
Common
Stock
Amount
|
|
Additional
Paid-in
Capital
|
|
Accumulated
Other
Comprehensive
(Loss) Income
|
|
Accumulated
Deficit
|
|
Total
Stockholders’
Equity (Deficit)
|
|||||||||||
Balance at December 31, 2012
|
183,697,213
|
|
|
$
|
183
|
|
|
$
|
1,550,345
|
|
|
$
|
(92
|
)
|
|
$
|
(1,254,002
|
)
|
|
$
|
296,434
|
|
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(244,760
|
)
|
|
(244,760
|
)
|
|||||
Other comprehensive income
|
—
|
|
|
—
|
|
|
—
|
|
|
238
|
|
|
—
|
|
|
238
|
|
|||||
Issuance of common stock under stock plans
|
836,438
|
|
|
1
|
|
|
2,294
|
|
|
—
|
|
|
—
|
|
|
2,295
|
|
|||||
Stock-based compensation expense
|
—
|
|
|
—
|
|
|
12,031
|
|
|
—
|
|
|
—
|
|
|
12,031
|
|
|||||
Balance at December 31, 2013
|
184,533,651
|
|
|
184
|
|
|
1,564,670
|
|
|
146
|
|
|
(1,498,762
|
)
|
|
66,238
|
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(268,542
|
)
|
|
(268,542
|
)
|
|||||
Other comprehensive loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(267
|
)
|
|
—
|
|
|
(267
|
)
|
|||||
Sale of shares of common stock, net
|
10,000,000
|
|
|
10
|
|
|
75,633
|
|
|
—
|
|
|
—
|
|
|
75,643
|
|
|||||
Issuance of common stock under stock plans
|
1,362,118
|
|
|
2
|
|
|
2,091
|
|
|
—
|
|
|
—
|
|
|
2,093
|
|
|||||
Stock-based compensation expense
|
—
|
|
|
—
|
|
|
10,006
|
|
|
—
|
|
|
—
|
|
|
10,006
|
|
|||||
Balance at December 31, 2014
|
195,895,769
|
|
|
196
|
|
|
1,652,400
|
|
|
(121
|
)
|
|
(1,767,304
|
)
|
|
(114,829
|
)
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(169,737
|
)
|
|
(169,737
|
)
|
|||||
Other comprehensive loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(111
|
)
|
|
—
|
|
|
(111
|
)
|
|||||
Sale of shares of common stock, net
|
28,750,000
|
|
|
29
|
|
|
145,620
|
|
|
—
|
|
|
—
|
|
|
145,649
|
|
|||||
Warrants transferred from other long-term liabilities
|
—
|
|
|
—
|
|
|
1,470
|
|
|
—
|
|
|
—
|
|
|
1,470
|
|
|||||
Issuance of common stock under stock plans
|
3,315,174
|
|
|
3
|
|
|
11,274
|
|
|
—
|
|
|
—
|
|
|
11,277
|
|
|||||
Stock-based compensation expense
|
—
|
|
|
—
|
|
|
21,977
|
|
|
—
|
|
|
—
|
|
|
21,977
|
|
|||||
Balance at December 31, 2015
|
227,960,943
|
|
|
$
|
228
|
|
|
$
|
1,832,741
|
|
|
$
|
(232
|
)
|
|
$
|
(1,937,041
|
)
|
|
$
|
(104,304
|
)
|
|
Year Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Cash flows from operating activities:
|
|
|
|
|
|
||||||
Net loss
|
$
|
(169,737
|
)
|
|
$
|
(268,542
|
)
|
|
$
|
(244,760
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
||||||
Depreciation and amortization
|
1,406
|
|
|
2,391
|
|
|
3,147
|
|
|||
Stock-based compensation expense
|
21,977
|
|
|
10,006
|
|
|
12,031
|
|
|||
Accretion of debt discount
|
25,034
|
|
|
29,534
|
|
|
26,290
|
|
|||
Accrual of interest paid in kind
|
3,817
|
|
|
—
|
|
|
—
|
|
|||
Gain on sale of business and other equity investment
|
(112
|
)
|
|
(838
|
)
|
|
—
|
|
|||
Changes in the fair value of warrants
|
548
|
|
|
(1,840
|
)
|
|
—
|
|
|||
Other
|
1,327
|
|
|
4,161
|
|
|
6,787
|
|
|||
Changes in assets and liabilities:
|
|
|
|
|
|
||||||
Trade and other receivables
|
(646
|
)
|
|
(941
|
)
|
|
(1,190
|
)
|
|||
Inventory
|
(235
|
)
|
|
509
|
|
|
(2,890
|
)
|
|||
Prepaid expenses and other current assets
|
(325
|
)
|
|
1,526
|
|
|
1,034
|
|
|||
Other long-term assets
|
1,340
|
|
|
(2,149
|
)
|
|
—
|
|
|||
Accounts payable, accrued compensation, and other accrued liabilities
|
(1,276
|
)
|
|
(13,945
|
)
|
|
8,691
|
|
|||
Clinical trial liability
|
(23,474
|
)
|
|
6,587
|
|
|
14,398
|
|
|||
Accrued collaboration liability
|
10,206
|
|
|
732
|
|
|
—
|
|
|||
Restructuring liability
|
(7,180
|
)
|
|
(2,302
|
)
|
|
(5,750
|
)
|
|||
Deferred revenue
|
(2,582
|
)
|
|
1,133
|
|
|
(14,871
|
)
|
|||
Other long-term liabilities
|
(1,673
|
)
|
|
(1,427
|
)
|
|
(1,690
|
)
|
|||
Net cash used in operating activities
|
(141,585
|
)
|
|
(235,405
|
)
|
|
(198,773
|
)
|
|||
Cash flows from investing activities:
|
|
|
|
|
|
||||||
Purchases of property and equipment
|
(447
|
)
|
|
(474
|
)
|
|
(2,171
|
)
|
|||
Proceeds from sale of property and equipment
|
1,346
|
|
|
392
|
|
|
143
|
|
|||
Proceeds from sale of business and other equity investment
|
95
|
|
|
838
|
|
|
—
|
|
|||
Proceeds from maturities of restricted cash and investments
|
19,789
|
|
|
20,354
|
|
|
17,268
|
|
|||
Purchase of restricted cash and investments
|
(5,650
|
)
|
|
(8,143
|
)
|
|
(6,085
|
)
|
|||
Proceeds from maturities of investments
|
178,936
|
|
|
252,891
|
|
|
325,171
|
|
|||
Purchases of investments
|
(143,992
|
)
|
|
(119,528
|
)
|
|
(189,975
|
)
|
|||
Net cash provided by investing activities
|
50,077
|
|
|
146,330
|
|
|
144,351
|
|
|||
Cash flows from financing activities:
|
|
|
|
|
|
||||||
Proceeds from issuance of common stock, net
|
145,649
|
|
|
75,643
|
|
|
—
|
|
|||
Proceeds from exercise of stock options and warrants
|
10,911
|
|
|
120
|
|
|
72
|
|
|||
Proceeds from employee stock purchase plan
|
568
|
|
|
1,438
|
|
|
1,429
|
|
|||
Principal payments on debt
|
(4,381
|
)
|
|
(11,709
|
)
|
|
(13,170
|
)
|
|||
Net cash provided by (used in) financing activities
|
152,747
|
|
|
65,492
|
|
|
(11,669
|
)
|
|||
Net increase (decrease) in cash and cash equivalents
|
61,239
|
|
|
(23,583
|
)
|
|
(66,091
|
)
|
|||
Cash and cash equivalents at beginning of year
|
80,395
|
|
|
103,978
|
|
|
170,069
|
|
|||
Cash and cash equivalents at end of year
|
$
|
141,634
|
|
|
$
|
80,395
|
|
|
$
|
103,978
|
|
Supplemental cash flow disclosure:
|
|
|
|
|
|
||||||
Cash paid for interest
|
$
|
19,822
|
|
|
$
|
19,109
|
|
|
$
|
19,160
|
|
Cash paid for taxes
|
$
|
192
|
|
|
$
|
60
|
|
|
$
|
—
|
|
Non-cash financing activity:
|
|
|
|
|
|
||||||
Issuance of warrants in connection with amendment to convertible notes
|
$
|
—
|
|
|
$
|
2,762
|
|
|
$
|
—
|
|
Equipment and furniture
|
5 years
|
Computer equipment and software
|
3 years
|
Leasehold improvements
|
Shorter of lease life or 7 years
|
|
December 31, 2015
|
|
December 31, 2014
|
||||||||||||||
|
Prior to
Adoption of ASU 2015-03 |
|
ASU 2015-03
Adjustment |
|
As Adopted
|
|
Prior to
Adoption of ASU 2015-03 (as previously reported) |
|
ASU 2015-03
Adjustment |
|
As Adopted
|
||||||
Other long-term assets
|
5,579
|
|
|
(3,270
|
)
|
|
2,309
|
|
|
8,340
|
|
|
(4,691
|
)
|
|
3,649
|
|
Total assets
|
335,612
|
|
|
(3,270
|
)
|
|
332,342
|
|
|
327,960
|
|
|
(4,691
|
)
|
|
323,269
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Current portion of convertible notes
|
—
|
|
|
—
|
|
|
—
|
|
|
98,880
|
|
|
(1,431
|
)
|
|
97,449
|
|
Current liabilities
|
52,251
|
|
|
—
|
|
|
52,251
|
|
|
171,860
|
|
|
(1,431
|
)
|
|
170,429
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Long-term portion of convertible notes
|
304,705
|
|
|
(3,270
|
)
|
|
301,435
|
|
|
182,395
|
|
|
(3,260
|
)
|
|
179,135
|
|
Total liabilities
|
439,916
|
|
|
(3,270
|
)
|
|
436,646
|
|
|
442,789
|
|
|
(4,691
|
)
|
|
438,098
|
|
|
Employee
Severance
and Other Benefits
|
|
Facility
Charges |
|
Asset
Impairment and Sales |
|
Legal and
Other Fees |
|
Total
|
||||||||||
Restructuring charge
|
$
|
5,775
|
|
|
$
|
65
|
|
|
$
|
188
|
|
|
$
|
59
|
|
|
$
|
6,087
|
|
Proceeds from sale of assets
|
—
|
|
|
—
|
|
|
100
|
|
|
—
|
|
|
100
|
|
|||||
Cash payments, net
|
(4,507
|
)
|
|
(65
|
)
|
|
—
|
|
|
(12
|
)
|
|
(4,584
|
)
|
|||||
Other items
|
22
|
|
|
—
|
|
|
(288
|
)
|
|
—
|
|
|
(266
|
)
|
|||||
Restructuring liability as of December 31, 2014
|
1,290
|
|
|
—
|
|
|
—
|
|
|
47
|
|
|
1,337
|
|
|||||
Restructuring charge (recovery)
|
(269
|
)
|
|
1,582
|
|
|
(981
|
)
|
|
(47
|
)
|
|
285
|
|
|||||
Proceeds from sale of assets
|
—
|
|
|
—
|
|
|
1,325
|
|
|
—
|
|
|
1,325
|
|
|||||
Cash payments, net
|
(1,021
|
)
|
|
(1,357
|
)
|
|
—
|
|
|
—
|
|
|
(2,378
|
)
|
|||||
Other items
|
—
|
|
|
278
|
|
|
(344
|
)
|
|
—
|
|
|
(66
|
)
|
|||||
Restructuring liability as of December 31, 2015
|
$
|
—
|
|
|
$
|
503
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
503
|
|
|
Facility
Charges
|
|
Other
|
|
Total
|
||||||
Restructuring liability as of December 31, 2012
|
$
|
19,202
|
|
|
$
|
20
|
|
|
$
|
19,222
|
|
Restructuring charge
|
662
|
|
|
569
|
|
|
1,231
|
|
|||
Proceeds from sale of assets
|
—
|
|
|
95
|
|
|
95
|
|
|||
Cash payments, net
|
(6,331
|
)
|
|
(434
|
)
|
|
(6,765
|
)
|
|||
Other items
|
(73
|
)
|
|
(238
|
)
|
|
(311
|
)
|
|||
Restructuring liability as of December 31, 2013
|
13,460
|
|
|
12
|
|
|
13,472
|
|
|||
Restructuring charge (recovery)
|
1,626
|
|
|
(117
|
)
|
|
1,509
|
|
|||
Proceeds from sale of assets
|
—
|
|
|
199
|
|
|
199
|
|
|||
Cash payments, net
|
(5,644
|
)
|
|
(8
|
)
|
|
(5,652
|
)
|
|||
Other items
|
12
|
|
|
(86
|
)
|
|
(74
|
)
|
|||
Restructuring liability as of December 31, 2014
|
9,454
|
|
|
—
|
|
|
9,454
|
|
|||
Restructuring charge
|
757
|
|
|
—
|
|
|
757
|
|
|||
Cash payments, net
|
(6,449
|
)
|
|
—
|
|
|
(6,449
|
)
|
|||
Other items
|
325
|
|
|
—
|
|
|
325
|
|
|||
Restructuring liability as of December 31, 2015
|
$
|
4,087
|
|
|
$
|
—
|
|
|
$
|
4,087
|
|
|
December 31, 2015
|
||||||||||||||
|
Amortized
Cost
|
|
Gross
Unrealized
Gains
|
|
Gross
Unrealized
Losses
|
|
Fair Value
|
||||||||
Cash and cash equivalents
|
$
|
141,634
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
141,634
|
|
Short-term investments
|
25,484
|
|
|
5
|
|
|
(63
|
)
|
|
25,426
|
|
||||
Long-term investments
|
83,665
|
|
|
2
|
|
|
(67
|
)
|
|
83,600
|
|
||||
Long-term restricted cash and investments
|
2,650
|
|
|
—
|
|
|
—
|
|
|
2,650
|
|
||||
Total cash and investments
|
$
|
253,433
|
|
|
$
|
7
|
|
|
$
|
(130
|
)
|
|
$
|
253,310
|
|
|
December 31, 2014
|
||||||||||||||
|
Amortized
Cost
|
|
Gross
Unrealized
Gains
|
|
Gross
Unrealized
Losses
|
|
Fair Value
|
||||||||
Cash and cash equivalents
|
$
|
80,395
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
80,395
|
|
Short-term investments
|
63,988
|
|
|
37
|
|
|
(135
|
)
|
|
63,890
|
|
||||
Short-term restricted cash and investments
|
12,105
|
|
|
107
|
|
|
—
|
|
|
12,212
|
|
||||
Long-term investments
|
81,600
|
|
|
1
|
|
|
(22
|
)
|
|
81,579
|
|
||||
Long-term restricted cash and investments
|
4,684
|
|
|
—
|
|
|
—
|
|
|
4,684
|
|
||||
Total cash and investments
|
$
|
242,772
|
|
|
$
|
145
|
|
|
$
|
(157
|
)
|
|
$
|
242,760
|
|
|
December 31, 2015
|
||||||||||||||
|
Amortized
Cost
|
|
Gross
Unrealized
Gains
|
|
Gross
Unrealized
Losses
|
|
Fair Value
|
||||||||
Money market funds
|
$
|
72,000
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
72,000
|
|
Commercial paper
|
78,155
|
|
|
—
|
|
|
—
|
|
|
78,155
|
|
||||
Corporate bonds
|
72,205
|
|
|
4
|
|
|
(118
|
)
|
|
72,091
|
|
||||
U.S. Treasury and government sponsored enterprises
|
28,434
|
|
|
1
|
|
|
(12
|
)
|
|
28,423
|
|
||||
Marketable equity securities
|
16
|
|
|
2
|
|
|
—
|
|
|
18
|
|
||||
Total investments
|
$
|
250,810
|
|
|
$
|
7
|
|
|
$
|
(130
|
)
|
|
$
|
250,687
|
|
|
December 31, 2014
|
||||||||||||||
|
Amortized
Cost
|
|
Gross
Unrealized
Gains
|
|
Gross
Unrealized
Losses
|
|
Fair Value
|
||||||||
Money market funds
|
$
|
23,376
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
23,376
|
|
Commercial paper
|
56,714
|
|
|
—
|
|
|
—
|
|
|
56,714
|
|
||||
Corporate bonds
|
143,444
|
|
|
35
|
|
|
(157
|
)
|
|
143,322
|
|
||||
U.S. Treasury and government sponsored enterprises
|
12,105
|
|
|
107
|
|
|
—
|
|
|
12,212
|
|
||||
Municipal bonds
|
2,659
|
|
|
3
|
|
|
—
|
|
|
2,662
|
|
||||
Total investments
|
$
|
238,298
|
|
|
$
|
145
|
|
|
$
|
(157
|
)
|
|
$
|
238,286
|
|
|
Mature within One Year
|
|
After One Year through Two Years
|
|
Fair Value
|
||||||
Money market funds
|
$
|
72,000
|
|
|
$
|
—
|
|
|
$
|
72,000
|
|
Commercial paper
|
78,155
|
|
|
—
|
|
|
78,155
|
|
|||
Corporate bonds
|
49,483
|
|
|
22,608
|
|
|
72,091
|
|
|||
U.S. Treasury and government sponsored enterprises
|
22,427
|
|
|
5,996
|
|
|
28,423
|
|
|||
Total
|
$
|
222,065
|
|
|
$
|
28,604
|
|
|
$
|
250,669
|
|
|
December 31,
|
||||||
|
2015
|
|
2014
|
||||
Raw materials
|
$
|
1,037
|
|
|
$
|
1,118
|
|
Work in process
|
2,251
|
|
|
2,845
|
|
||
Finished goods
|
583
|
|
|
559
|
|
||
Total
|
3,871
|
|
|
4,522
|
|
||
Less: non-current portion included in Other long-term assets
|
(1,255
|
)
|
|
(2,141
|
)
|
||
Inventory
|
$
|
2,616
|
|
|
$
|
2,381
|
|
|
December 31,
|
||||||
|
2015
|
|
2014
|
||||
Laboratory equipment
|
$
|
4,749
|
|
|
$
|
13,677
|
|
Computer equipment and software
|
11,890
|
|
|
14,840
|
|
||
Furniture and fixtures
|
2,253
|
|
|
3,701
|
|
||
Leasehold improvements
|
6,395
|
|
|
16,364
|
|
||
Construction-in-progress
|
456
|
|
|
120
|
|
||
|
25,743
|
|
|
48,702
|
|
||
Less: accumulated depreciation and amortization
|
(24,309
|
)
|
|
(46,270
|
)
|
||
Property and equipment, net
|
$
|
1,434
|
|
|
$
|
2,432
|
|
|
December 31,
|
||||||
|
2015
|
|
2014
|
||||
Convertible Senior Subordinated Notes due 2019
|
$
|
198,708
|
|
|
$
|
179,135
|
|
Secured Convertible Notes due 2018
|
102,727
|
|
|
97,449
|
|
||
Silicon Valley Bank term loan
|
80,000
|
|
|
80,000
|
|
||
Silicon Valley Bank line of credit
|
—
|
|
|
381
|
|
||
Total debt
|
381,435
|
|
|
356,965
|
|
||
Less: current portion
|
—
|
|
|
(97,830
|
)
|
||
Long-term debt
|
$
|
381,435
|
|
|
$
|
259,135
|
|
|
Year Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Stated coupon interest
|
$
|
12,218
|
|
|
$
|
12,253
|
|
|
$
|
12,219
|
|
Amortization of debt discount and debt issuance costs
|
19,573
|
|
|
17,804
|
|
|
16,201
|
|
|||
Total interest expense
|
$
|
31,791
|
|
|
$
|
30,057
|
|
|
$
|
28,420
|
|
|
Year Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Stated coupon interest
|
$
|
6,792
|
|
|
$
|
6,000
|
|
|
$
|
6,000
|
|
Amortization of debt discount, debt issuance costs and interest paid in kind
|
9,278
|
|
|
11,731
|
|
|
10,089
|
|
|||
Total interest expense
|
$
|
16,070
|
|
|
$
|
17,731
|
|
|
$
|
16,089
|
|
Year Ending December 31, (1)
|
|
||
2016
|
$
|
—
|
|
2017
|
80,000
|
|
|
2018
|
124,972
|
|
|
2019
|
287,500
|
|
|
Thereafter
|
—
|
|
(1)
|
The actual timing of payments made may differ materially.
|
|
December 31, 2015
|
||||||||||
|
Level 1
|
|
Level 2
|
|
Total
|
||||||
Money market funds
|
$
|
72,000
|
|
|
$
|
—
|
|
|
$
|
72,000
|
|
Commercial paper
|
—
|
|
|
78,155
|
|
|
78,155
|
|
|||
Corporate bonds
|
—
|
|
|
72,091
|
|
|
72,091
|
|
|||
U.S. Treasury and government sponsored enterprises
|
—
|
|
|
28,423
|
|
|
28,423
|
|
|||
Marketable equity securities
|
18
|
|
|
—
|
|
|
18
|
|
|||
Total financial assets
|
$
|
72,018
|
|
|
$
|
178,669
|
|
|
$
|
250,687
|
|
|
December 31, 2014
|
||||||||||||||
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
||||||||
Financial assets:
|
|
|
|
|
|
|
|
||||||||
Money market funds
|
$
|
23,376
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
23,376
|
|
Commercial paper
|
—
|
|
|
56,714
|
|
|
—
|
|
|
56,714
|
|
||||
Corporate bonds
|
—
|
|
|
143,322
|
|
|
—
|
|
|
143,322
|
|
||||
U.S. Treasury and government sponsored enterprises
|
—
|
|
|
12,212
|
|
|
—
|
|
|
12,212
|
|
||||
Municipal bonds
|
—
|
|
|
2,662
|
|
|
—
|
|
|
2,662
|
|
||||
Total financial assets
|
$
|
23,376
|
|
|
$
|
214,910
|
|
|
$
|
—
|
|
|
$
|
238,286
|
|
Financial liabilities:
|
|
|
|
|
|
|
|
||||||||
Warrants
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
921
|
|
|
$
|
921
|
|
Balance at December 31, 2014
|
$
|
921
|
|
Unrealized loss at final re-measurement of warrants on March 18, 2015,
included in Interest income and other, net
|
549
|
|
|
Transfer of warrants from Other long-term liabilities to Additional paid-in capital at their estimated fair value upon warrant repricing on March 18, 2015
|
(1,470
|
)
|
|
Balance at December 31, 2015
|
$
|
—
|
|
|
December 31, 2015
|
|
December 31, 2014
|
||||||||||||
|
Carrying
Amount
|
|
Fair Value
|
|
Carrying
Amount
|
|
Fair Value
|
||||||||
2019 Notes
|
$
|
198,708
|
|
|
$
|
336,260
|
|
|
$
|
179,135
|
|
|
$
|
156,889
|
|
Silicon Valley Bank Term Loan
|
$
|
80,000
|
|
|
$
|
79,815
|
|
|
$
|
80,000
|
|
|
$
|
79,943
|
|
Silicon Valley Bank Line of Credit
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
381
|
|
|
$
|
381
|
|
•
|
When available, we value investments based on quoted prices for those financial instruments, which is a Level 1 input. Our remaining investments are valued using third-party pricing sources, which use observable market prices, interest rates and yield curves observable at commonly quoted intervals of similar assets as observable inputs for pricing, which is a Level 2 input.
|
•
|
The 2019 Notes are valued using a third-party pricing model that is based in part on average trading prices, which is a Level 2 input. The 2019 Notes are not marked-to-market and are shown at their initial fair value less the unamortized discount; the portion of the value allocated to the conversion option is included in Stockholders’ deficit on the accompanying Consolidated Balance Sheets.
|
•
|
We estimate the fair value of our other debt instruments, where possible, using the net present value of the payments. For the Silicon Valley Bank term loan and line of credit, we use an interest rate that is consistent with money-market rates that would have been earned on our non-interest-bearing compensating balances as our discount rate, which is a Level 2 input. For the Deerfield Notes, we used a discount rate of
17%
, which we estimate as our current borrowing rate for similar debt as of
December 31, 2015
, which is a Level 3 input.
|
•
|
The 2014 Warrants were valued using a Monte Carlo simulation model until December 31, 2014 and the Black-Scholes Merton option pricing model on March 18, 2015. The expected life was based on the contractual terms of the 2014 Warrants, and in certain simulations, assumed the
two
year extension that would result from our exercise of the Extension Option; as of and subsequent to September 30, 2014, we estimated that it was probable that we would exercise this
two
-year extension. We considered implied volatility as well as our historical volatility in developing our estimate of expected volatility. The fair value of the 2014 Warrants was estimated using the following assumptions, which, except for risk-free interest rate, are Level 3 inputs (dollars in thousands):
|
|
March 18, 2015
|
|
December 31, 2014
|
||
Risk-free interest rate
|
0.87
|
%
|
|
1.07
|
%
|
Dividend yield
|
—
|
%
|
|
—
|
%
|
Volatility
|
95
|
%
|
|
96
|
%
|
Average expected life
|
2.8 years
|
|
|
3.1 years
|
|
|
Year Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Research and development expense
|
$
|
11,691
|
|
|
$
|
3,245
|
|
|
$
|
6,021
|
|
Selling, general and administrative
|
10,286
|
|
|
6,783
|
|
|
5,948
|
|
|||
Restructuring-related stock compensation expense (recovery)
|
—
|
|
|
(22
|
)
|
|
49
|
|
|||
Total employee stock-based compensation expense
|
$
|
21,977
|
|
|
$
|
10,006
|
|
|
$
|
12,018
|
|
|
2015
|
|
2014
|
|
2013
|
||||||
Stock options
|
$
|
2.55
|
|
|
$
|
1.46
|
|
|
$
|
2.97
|
|
ESPP
|
$
|
1.20
|
|
|
$
|
1.28
|
|
|
$
|
1.64
|
|
|
Stock Options
|
|||||||
|
2015
|
|
2014
|
|
2013
|
|||
Risk-free interest rate
|
1.22
|
%
|
|
1.80
|
%
|
|
1.51
|
%
|
Dividend yield
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
Volatility
|
93
|
%
|
|
85
|
%
|
|
61
|
%
|
Expected life
|
4.5 years
|
|
|
5.5 years
|
|
|
5.6 years
|
|
|
ESPP
|
|||||||
|
2015
|
|
2014
|
|
2013
|
|||
Risk-free interest rate
|
0.15
|
%
|
|
0.06
|
%
|
|
0.11
|
%
|
Dividend yield
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
Volatility
|
98
|
%
|
|
69
|
%
|
|
66
|
%
|
Expected life
|
6 months
|
|
|
6 months
|
|
|
6 months
|
|
|
Options Outstanding
|
|
Options Outstanding and
Exercisable
|
|||||||||||||
Exercise Price Range
|
Number
|
|
Weighted
Average
Remaining
Contractual Life
|
|
Weighted
Average
Exercise
Price
|
|
Number
Exercisable
|
|
Weighted
Average
Exercise
Price
|
|||||||
$1.46 - $1.87
|
7,997,474
|
|
|
5.78 years
|
|
$
|
1.70
|
|
|
3,857,469
|
|
|
$
|
1.70
|
|
|
$1.90
|
3,738,000
|
|
|
6.07 years
|
|
$
|
1.90
|
|
|
1,826,502
|
|
|
$
|
1.90
|
|
|
$2.57 - $4.88
|
2,772,796
|
|
|
5.27 years
|
|
$
|
3.80
|
|
|
1,681,199
|
|
|
$
|
3.98
|
|
|
$5.01 - $5.51
|
4,043,479
|
|
|
4.02 years
|
3,186,063
|
|
$
|
5.44
|
|
|
3,186,063
|
|
|
$
|
5.44
|
|
$5.55 - $6.02
|
2,600,943
|
|
|
4.70 years
|
|
$
|
5.73
|
|
|
1,890,661
|
|
|
$
|
5.70
|
|
|
$6.21
|
2,822,900
|
|
|
6.69 years
|
|
$
|
6.21
|
|
|
—
|
|
|
|
|||
$6.25 - $11.66
|
3,450,262
|
|
|
2.53 years
|
|
$
|
8.71
|
|
|
3,224,283
|
|
|
$
|
8.82
|
|
|
|
27,425,854
|
|
|
5.09 years
|
|
$
|
4.22
|
|
|
15,666,177
|
|
|
$
|
4.68
|
|
|
Year Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Domestic
|
$
|
(158,839
|
)
|
|
$
|
(237,780
|
)
|
|
$
|
(236,076
|
)
|
Foreign
|
(10,843
|
)
|
|
(30,944
|
)
|
|
(8,780
|
)
|
|||
Total
|
$
|
(169,682
|
)
|
|
$
|
(268,724
|
)
|
|
$
|
(244,856
|
)
|
|
Year Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Current:
|
|
|
|
|
|
||||||
Federal
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
State
|
55
|
|
|
(182
|
)
|
|
12
|
|
|||
Total current tax expense
|
55
|
|
|
(182
|
)
|
|
12
|
|
|||
Deferred:
|
|
|
|
|
|
||||||
Federal
|
—
|
|
|
—
|
|
|
(106
|
)
|
|||
State
|
—
|
|
|
—
|
|
|
(2
|
)
|
|||
Total deferred tax expense
|
—
|
|
|
—
|
|
|
(108
|
)
|
|||
Income tax provision (benefit)
|
$
|
55
|
|
|
$
|
(182
|
)
|
|
$
|
(96
|
)
|
|
Year Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
U.S. federal income tax benefit at statutory rate
|
$
|
(57,692
|
)
|
|
$
|
(91,366
|
)
|
|
$
|
(83,251
|
)
|
Unutilized net operating losses
|
54,139
|
|
|
87,448
|
|
|
(3,438
|
)
|
|||
Non-deductible interest
|
3,308
|
|
|
3,598
|
|
|
3,380
|
|
|||
Stock-based compensation
|
195
|
|
|
255
|
|
|
393
|
|
|||
State tax expense
|
55
|
|
|
(182
|
)
|
|
10
|
|
|||
Available-for-sale investments
|
—
|
|
|
—
|
|
|
(106
|
)
|
|||
Impact of intellectual property rights transfer
|
—
|
|
|
—
|
|
|
82,858
|
|
|||
Other
|
50
|
|
|
65
|
|
|
58
|
|
|||
Income tax (benefit) provision
|
$
|
55
|
|
|
$
|
(182
|
)
|
|
$
|
(96
|
)
|
|
December 31,
|
||||||
|
2015
|
|
2014
|
||||
Deferred tax assets:
|
|
|
|
||||
Net operating loss carry-forwards
|
$
|
464,504
|
|
|
$
|
446,343
|
|
Tax credit and charitable contribution carry-forwards
|
64,350
|
|
|
64,368
|
|
||
Amortization of deferred stock compensation – non-qualified
|
14,615
|
|
|
27,500
|
|
||
Accruals and reserves not currently deductible
|
7,775
|
|
|
6,521
|
|
||
Book over tax depreciation and amortization
|
1,752
|
|
|
5,118
|
|
||
Deferred revenue
|
—
|
|
|
988
|
|
||
Total deferred tax assets
|
552,996
|
|
|
550,838
|
|
||
Valuation allowance
|
(523,574
|
)
|
|
(511,171
|
)
|
||
Net deferred tax assets
|
29,422
|
|
|
39,667
|
|
||
Deferred tax liabilities:
|
|
|
|
||||
Unrealized gain on derivatives
|
(497
|
)
|
|
(704
|
)
|
||
Convertible debt
|
(28,925
|
)
|
|
(38,963
|
)
|
||
Total deferred tax liabilities
|
(29,422
|
)
|
|
(39,667
|
)
|
||
Net deferred taxes
|
$
|
—
|
|
|
$
|
—
|
|
|
Year Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Beginning balance
|
$
|
58,215
|
|
|
$
|
55,077
|
|
|
$
|
47,298
|
|
Increase (decrease) relating to prior year provision
|
21,696
|
|
|
719
|
|
|
(112
|
)
|
|||
Increase relating to current year provision
|
8,727
|
|
|
2,706
|
|
|
7,891
|
|
|||
Reductions based on the lapse of the applicable statutes of limitations
|
—
|
|
|
(287
|
)
|
|
—
|
|
|||
Ending balance
|
$
|
88,638
|
|
|
$
|
58,215
|
|
|
$
|
55,077
|
|
|
Year Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Numerator:
|
|
|
|
|
|
||||||
Net loss
|
$
|
(169,737
|
)
|
|
$
|
(268,542
|
)
|
|
$
|
(244,760
|
)
|
Denominator:
|
|
|
|
|
|
||||||
Shares used in computing basic and diluted net loss per share
|
209,227
|
|
|
194,299
|
|
|
184,062
|
|
|||
Net loss per share, basic and diluted
|
$
|
(0.81
|
)
|
|
$
|
(1.38
|
)
|
|
$
|
(1.33
|
)
|
|
December 31,
|
|||||||
|
2015
|
|
2014
|
|
2013
|
|||
Convertible debt
|
88,008
|
|
|
75,734
|
|
|
54,123
|
|
Outstanding stock options, unvested RSUs and ESPP contributions
|
28,470
|
|
|
28,930
|
|
|
21,401
|
|
Warrants
|
1,000
|
|
|
1,000
|
|
|
1,441
|
|
Total potentially dilutive shares
|
117,478
|
|
|
105,664
|
|
|
76,965
|
|
Year Ending December 31,
|
Operating
Leases (1)
|
||
2016
|
$
|
14,236
|
|
2017
|
8,474
|
|
|
2018
|
3,007
|
|
|
|
$
|
25,717
|
|
(1)
|
Minimum payments have not been reduced by minimum sublease rentals of
$6.1 million
due in the future under noncancelable subleases.
|
|
Original
Term
(Expiration)
|
Renewal Options
|
Future
Minimum
Lease
Payments
|
||
Building Lease #1 and 2
|
May 2017
|
2 additional periods of 5 years
|
$
|
12,732
|
|
Building Lease #3
|
July 2018
|
1 additional period of 5 years
|
12,985
|
|
|
Total
|
|
|
$
|
25,717
|
|
|
Year Ended December 31,
|
|||||||
|
2015
|
|
2014
|
|
2013
|
|||
Percentage of revenues earned in the United States
|
91
|
%
|
|
99
|
%
|
|
97
|
%
|
Percentage of revenues earned in the European Union
(1)
|
9
|
%
|
|
1
|
%
|
|
3
|
%
|
|
Year Ended December 31,
|
|||||||
|
2015
|
|
2014
|
|
2013
|
|||
Product sales:
|
|
|
|
|
|
|||
Diplomat Specialty Pharmacy
|
83
|
%
|
|
99
|
%
|
|
45
|
%
|
Collaboration agreement:
|
|
|
|
|
|
|||
Bristol-Myers Squibb
|
—
|
%
|
|
—
|
%
|
|
52
|
%
|
|
Quarter Ended
|
||||||||||||||
|
December 31,
|
|
September 30,
|
|
June 30,
|
|
March 31,
|
||||||||
2015:
|
|
|
|
|
|
|
|
||||||||
Revenues
|
$
|
9,938
|
|
|
$
|
9,854
|
|
|
$
|
7,992
|
|
|
$
|
9,388
|
|
Gross profit
|
$
|
8,915
|
|
|
$
|
8,434
|
|
|
$
|
7,306
|
|
|
$
|
8,622
|
|
Loss from operations
|
$
|
(31,600
|
)
|
|
$
|
(35,781
|
)
|
|
$
|
(31,280
|
)
|
|
$
|
(22,760
|
)
|
Net loss
|
$
|
(43,641
|
)
|
|
$
|
(47,564
|
)
|
|
$
|
(43,362
|
)
|
|
$
|
(35,170
|
)
|
Net loss per share, basic and diluted
|
$
|
(0.19
|
)
|
|
$
|
(0.22
|
)
|
|
$
|
(0.22
|
)
|
|
$
|
(0.18
|
)
|
2014:
|
|
|
|
|
|
|
|
||||||||
Revenues
|
$
|
7,353
|
|
|
$
|
6,291
|
|
|
$
|
6,562
|
|
|
$
|
4,905
|
|
Gross profit
|
$
|
6,669
|
|
|
$
|
5,718
|
|
|
$
|
6,085
|
|
|
$
|
4,596
|
|
Loss from operations
|
$
|
(46,208
|
)
|
|
$
|
(51,574
|
)
|
|
$
|
(61,688
|
)
|
|
$
|
(64,988
|
)
|
Net loss
|
$
|
(57,953
|
)
|
|
$
|
(62,560
|
)
|
|
$
|
(73,410
|
)
|
|
$
|
(74,619
|
)
|
Net loss per share, basic and diluted
|
$
|
(0.30
|
)
|
|
$
|
(0.32
|
)
|
|
$
|
(0.38
|
)
|
|
$
|
(0.39
|
)
|
ITEM 9.
|
CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
|
ITEM 9B.
|
OTHER INFORMATION
|
ITEM 10.
|
DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
|
ITEM 11.
|
EXECUTIVE COMPENSATION
|
ITEM 12.
|
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
|
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 (1)
|
|
Number of securities remaining
available for future issuance under equity
compensation plans (excluding securities reflected in column (a))
|
||||
|
|
(a)
|
|
(b)
|
|
(c)
|
||||
Equity compensation plans approved by stockholders (2)
|
|
29,428,042
|
|
|
$
|
4.19
|
|
|
9,088,801
|
|
Equity compensation plans not approved by stockholders (3)
|
|
—
|
|
|
n/a
|
|
|
450,042
|
|
|
Total
|
|
29,428,042
|
|
|
$
|
4.19
|
|
|
9,538,843
|
|
(1)
|
The weighted average exercise price does not take into account the shares subject to outstanding restricted stock units, or RSUs, which have no exercise price.
|
(2)
|
Represents shares of our common stock issuable pursuant to the 2000 Plan, the 2011 Plan, the Director Plan and the ESPP.
|
(3)
|
Represents shares of our common stock issuable pursuant to the 401(k) Plan. We sponsor a 401(k) Plan whereby eligible employees may elect to contribute up to the lesser of 50% of their annual compensation or the statutorily prescribed annual limit allowable under Internal Revenue Service regulations. The 401(k) Plan permits us to make matching contributions on behalf of all participants. We match 100% of the first 3% of participant contributions into the 401(k) Plan in the form of our common stock.
|
ITEM 13.
|
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
|
ITEM 14.
|
PRINCIPAL ACCOUNTING FEES AND SERVICES
|
ITEM 15.
|
EXHIBITS, FINANCIAL STATEMENT SCHEDULES
|
(a)
|
The following documents are being filed as part of this report:
|
|
Page
|
|
|
E
XELIXIS
, I
NC
.
|
By:
|
|
/s/ M
ICHAEL
M. M
ORRISSEY
|
|
|
Michael M. Morrissey, Ph.D.
|
|
|
President and Chief Executive Officer
|
Signatures
|
|
Title
|
|
Date
|
|
|
|
||
/s/ M
ICHAEL
M. M
ORRISSEY
|
|
Director, President and
|
|
February 29, 2016
|
Michael M. Morrissey, Ph.D.
|
|
Chief Executive Officer (Principal Executive Officer)
|
|
|
|
|
|
||
/s/ C
HRISTOPHER
S
ENNER
|
|
Executive Vice President and Chief Financial Officer
|
|
February 29, 2016
|
Christopher Senner
|
|
(Principal Financial and Accounting Officer)
|
|
|
|
|
|
||
/s/ S
TELIOS
P
APADOPOULOS
|
|
Chairman of the Board
|
|
February 29, 2016
|
Stelios Papadopoulos, Ph.D.
|
|
|
|
|
|
|
|
||
/s/ C
HARLES
C
OHEN
|
|
Director
|
|
February 29, 2016
|
Charles Cohen, Ph.D.
|
|
|
|
|
|
|
|
||
/s/ C
ARL
B. F
ELDBAUM
|
|
Director
|
|
February 29, 2016
|
Carl B. Feldbaum, Esq.
|
|
|
|
|
|
|
|
||
/s/ A
LAN
M. G
ARBER
|
|
Director
|
|
February 29, 2016
|
Alan M. Garber, M.D., Ph.D.
|
|
|
|
|
Signatures
|
|
Title
|
|
Date
|
|
|
|
||
/s/ V
INCENT
T. M
ARCHESI
|
|
Director
|
|
February 29, 2016
|
Vincent T. Marchesi, M.D., Ph.D.
|
|
|
|
|
|
|
|
||
/s/ G
EORGE
P
OSTE
|
|
Director
|
|
February 29, 2016
|
George Poste, D.V.M., Ph.D.
|
|
|
|
|
|
|
|
||
/s/ G
EORGE
A. S
CANGOS
|
|
Director
|
|
February 29, 2016
|
George A. Scangos, Ph.D.
|
|
|
|
|
|
|
|
||
/s/ L
ANCE
W
ILLSEY
|
|
Director
|
|
February 29, 2016
|
Lance Willsey, M.D.
|
|
|
|
|
|
|
|
||
/s/ J
ACK
L. W
YSZOMIERSKI
|
|
Director
|
|
February 29, 2016
|
Jack L. Wyszomierski
|
|
|
|
|
Exhibit
Number
|
|
Exhibit Description
|
|
Incorporation by Reference
|
|
Filed
Herewith
|
||||||
Form
|
|
File Number
|
|
Exhibit/
Appendix
Reference
|
|
Filing Date
|
|
|||||
3.1
|
|
Amended and Restated Certificate of Incorporation of Exelixis, Inc.
|
|
10-K
|
|
000-30235
|
|
3.1
|
|
3/10/2010
|
|
|
3.2
|
|
Certificate of Amendment of Amended and Restated Certificate of Incorporation of Exelixis, Inc.
|
|
10-K
|
|
000-30235
|
|
3.2
|
|
3/10/2010
|
|
|
3.3
|
|
Certificate of Amendment of Amended and Restated Certificate of Incorporation of Exelixis, Inc.
|
|
8-K
|
|
000-30235
|
|
3.1
|
|
5/25/2012
|
|
|
3.4
|
|
Certificate of Ownership and Merger Merging X-Ceptor Therapeutics, Inc. with and into Exelixis, Inc.
|
|
8-K
|
|
000-30235
|
|
3.1
|
|
10/15/2014
|
|
|
3.5
|
|
Certificate of Change of Registered Agent and/or Registered Office of Exelixis, Inc.
|
|
8-K
|
|
000-30255
|
|
3.2
|
|
10/15/2014
|
|
|
3.6
|
|
Amended and Restated Bylaws of Exelixis, Inc.
|
|
8-K
|
|
000-30235
|
|
3.1
|
|
12/5/2011
|
|
|
4.1
|
|
Specimen Common Stock Certificate.
|
|
S-1,
as amended
|
|
333-96335
|
|
4.1
|
|
4/7/2000
|
|
|
4.2
|
|
Amended and Restated Secured Convertible Note dated July 1, 2015 in favor of Deerfield Partners, L.P.
|
|
10-Q
|
|
000-30235
|
|
4.2
|
|
8/11/2015
|
|
|
4.3
|
|
Amended and Restated Secured Convertible Note dated July 1, 2015 in favor of Deerfield International Master Fund, L.P.
|
|
10-Q
|
|
000-30235
|
|
4.3
|
|
8/11/2015
|
|
|
4.4
|
|
Registration Rights Agreement dated January 22, 2014 by and among Exelixis, Inc., Deerfield Partners, L.P. and Deerfield International Master Fund, L.P.
|
|
8-K
|
|
000-30235
|
|
4.2
|
|
1/22/2014
|
|
|
4.5
|
|
Form of Warrant to Purchase Common Stock of Exelixis, Inc. issued to OTA LLC
|
|
10-Q
|
|
000-30235
|
|
4.5
|
|
11/10/2015
|
|
|
4.6
|
|
Indenture dated August 14, 2012 by and between Exelixis, Inc. and Wells Fargo Bank, National Association
|
|
8-K
|
|
000-30235
|
|
4.1
|
|
8/14/2012
|
|
|
4.7
|
|
First Supplemental Indenture dated August 14, 2012 to Indenture dated August 14, 2012 by and between Exelixis, Inc. and Wells Fargo Bank, National Association
|
|
8-K
|
|
000-30235
|
|
4.2
|
|
8/14/2012
|
|
|
4.8
|
|
Form of 4.25% Convertible Senior Subordinated Note due 2019
|
|
8-K
|
|
000-30235
|
|
4.2 (Exhibit A)
|
|
8/14/2012
|
|
|
10.1†
|
|
Form of Indemnity Agreement.
|
|
S-1,
as amended
|
|
333-96335
|
|
10.1
|
|
3/17/2000
|
|
|
10.2
†
|
|
2000 Equity Incentive Plan.
|
|
10-Q
|
|
000-30235
|
|
10.1
|
|
5/3/2007
|
|
|
10.3
†
|
|
Form of Stock Option Agreement under the 2000 Equity Incentive Plan (early exercise permissible).
|
|
10-Q
|
|
000-30235
|
|
10.2
|
|
11/8/2004
|
|
|
10.4
†
|
|
Form of Stock Option Agreement under the 2000 Equity Incentive Plan (early exercise may be restricted).
|
|
8-K
|
|
000-30235
|
|
10.1
|
|
12/15/2004
|
|
|
Exhibit
Number
|
|
Exhibit Description
|
|
Incorporation by Reference
|
|
Filed
Herewith
|
||||||
Form
|
|
File Number
|
|
Exhibit/
Appendix
Reference
|
|
Filing Date
|
|
|||||
10.5
†
|
|
Form of Restricted Stock Unit Agreement under the 2000 Equity Incentive Plan.
|
|
10-K
|
|
000-30235
|
|
10.6
|
|
3/10/2010
|
|
|
10.6
†
|
|
2000 Non-Employee Directors’ Stock Option Plan.
|
|
10-K
|
|
000-30235
|
|
10.6
|
|
2/20/2014
|
|
|
10.7
†
|
|
Form of Stock Option Agreement under the 2000 Non-Employee Directors’ Stock Option Plan.
|
|
10-K
|
|
000-30235
|
|
10.7
|
|
2/22/2011
|
|
|
10.8
†
|
|
2000 Employee Stock Purchase Plan.
|
|
Schedule 14A
|
|
000-30235
|
|
A
|
|
4/13/2009
|
|
|
10.9
†
|
|
2011 Equity Incentive Plan.
|
|
8-K
|
|
000-30235
|
|
10.1
|
|
5/24/2011
|
|
|
10.10
†
|
|
Form of Stock Option Agreement under the 2011 Equity Incentive Plan
|
|
10-Q
|
|
000-30235
|
|
10.3
|
|
8/4/2011
|
|
|
10.11
†
|
|
Form of Restricted Stock Unit Agreement under the 2011 Equity Incentive Plan
|
|
10-Q
|
|
000-30235
|
|
10.4
|
|
8/4/2011
|
|
|
10.12
†
|
|
Form of Stock Option Agreement (International) under the Exelixis, Inc. 2011 Equity Incentive Plan
|
|
10-Q
|
|
000-30235
|
|
10.6
|
|
7/31/2014
|
|
|
10.13
†
|
|
Exelixis, Inc. 2014 Equity Incentive Plan
|
|
8-K
|
|
000-30235
|
|
10.1
|
|
5/29/2014
|
|
|
10.14
†
|
|
Form of Stock Option Agreement under the Exelixis, Inc. 2014 Equity Incentive Plan
|
|
10-Q
|
|
000-30235
|
|
10.2
|
|
7/31/2014
|
|
|
10.15
†
|
|
Form of Stock Option Agreement (International) under the Exelixis, Inc. 2014 Equity Incentive Plan
|
|
10-Q
|
|
000-30235
|
|
10.3
|
|
7/31/2014
|
|
|
10.16
†
|
|
Form of Stock Option Agreement (Non-Employee Director) under the Exelixis, Inc. 2014 Equity Incentive Plan
|
|
10-Q
|
|
000-30235
|
|
10.4
|
|
7/31/2014
|
|
|
10.17
†
|
|
Form of Restricted Stock Unit Agreement under the Exelixis, Inc. 2014 Equity Incentive Plan
|
|
10-Q
|
|
000-30235
|
|
10.5
|
|
7/31/2014
|
|
|
1018
†
|
|
Form of Restricted Stock Unit Agreement (Non-Employee Director) under the 2014 Equity Incentive Plan
|
|
8-K
|
|
000-30235
|
|
10.1
|
|
10/16/2014
|
|
|
10.19
†
|
|
Non-Employee Director Equity Compensation Policy under the 2014 Equity Incentive Plan
|
|
|
|
|
|
|
|
|
|
X
|
10.20
†
|
|
Offer Letter Agreement, dated February 3, 2000, between Michael Morrissey, Ph.D., and Exelixis, Inc.
|
|
10-Q
|
|
000-30235
|
|
10.43
|
|
8/5/2004
|
|
|
10.21
†
|
|
Offer Letter Agreement, dated June 30, 2015, between Christopher Senner, and Exelixis, Inc.
|
|
10-Q
|
|
000-30235
|
|
10.5
|
|
11/10/2015
|
|
|
10.22
†
|
|
Offer Letter Agreement, dated June 20, 2006, between Exelixis, Inc. and Gisela M. Schwab, M.D.
|
|
8-K
|
|
000-30235
|
|
10.1
|
|
6/26/2006
|
|
|
10.23
†
|
|
Offer Letter Agreement, dated February 10, 2014, between Exelixis, Inc. and Jeffrey J. Hessekiel.
|
|
10-Q
|
|
000-30235
|
|
10.4
|
|
5/1/2014
|
|
|
10.24
†
|
|
Offer Letter Agreement, dated August 11, 2000, between Exelixis, Inc. and Peter Lamb.
|
|
|
|
|
|
|
|
|
|
X
|
Exhibit
Number
|
|
Exhibit Description
|
|
Incorporation by Reference
|
|
Filed
Herewith
|
||||||
Form
|
|
File Number
|
|
Exhibit/
Appendix
Reference
|
|
Filing Date
|
|
|||||
10.25
†
|
|
Transition and Consulting Agreement, dated May 7, 2014, between Exelixis, Inc. and Frank Karbe
|
|
10-Q
|
|
000-30235
|
|
10.7
|
|
7/31/2014
|
|
|
10.26
†
|
|
Offer Letter Agreement, dated May 9, 2005, between Exelixis, Inc. and Deborah Burke
|
|
10-Q
|
|
000-30235
|
|
10.8
|
|
7/31/2014
|
|
|
10.27
†
|
|
Special One-Time Bonus Memorandum for Deborah Burke dated May 15, 2014
|
|
10-Q
|
|
000-30235
|
|
10.9
|
|
7/31/2014
|
|
|
10.28
†
|
|
Resignation Agreement dated July 22, 2010, by and between Exelixis, Inc. and George A. Scangos
|
|
10-Q
|
|
000-30235
|
|
10.1
|
|
11/4/2010
|
|
|
10.29
†
|
|
Compensation Information for Named Executive Officers (2015 cash bonus and 2016 compensation)
|
|
8-K
|
|
000-30235
|
|
Item 5.02 disclosure
|
|
2/16/2016
|
|
|
10.30
†
|
|
Compensation Information for Non-Employee Directors.
|
|
10-Q
|
|
000-30235
|
|
10.3
|
|
5/1/2014
|
|
|
10.31
†
|
|
Exelixis, Inc. Change in Control and Severance Benefit Plan, as amended and restated.
|
|
10-Q
|
|
000-30235
|
|
10.2
|
|
10/27/2011
|
|
|
10.32
|
|
Lease, dated May 12, 1999, between Britannia Pointe Grand Limited Partnership and Exelixis, Inc.
|
|
S-1,
as amended
|
|
333-96335
|
|
10.11
|
|
2/7/2000
|
|
|
10.33
|
|
First Amendment, dated March 29, 2000, to Lease, dated May 12, 1999, between Britannia Pointe Grand Limited Partnership and Exelixis, Inc.
|
|
10-Q
|
|
000-30235
|
|
10.1
|
|
5/15/2000
|
|
|
10.34
|
|
Second Amendment, dated January 31, 2001, to Lease dated May 12, 1999, between Britannia Pointe Grand Limited Partnership and Exelixis, Inc.
|
|
S-1,
as amended
|
|
333-152166
|
|
10.44
|
|
7/7/2008
|
|
|
10.35
|
|
Third Amendment, dated May 24, 2001, to Lease dated May 12, 1999, between Britannia Pointe Grand Limited Partnership and Exelixis, Inc.
|
|
10-K
|
|
000-30235
|
|
10.46
|
|
2/22/2011
|
|
|
10.36
|
|
Partial Lease Termination Agreement dated June 30, 2015, by and between Britannia Pointe Grand Limited Partnership and Exelixis, Inc.
|
|
10-Q
|
|
000-30235
|
|
10.1
|
|
8/11/2015
|
|
|
10.37
|
|
Lease Agreement, dated May 24, 2001, between Britannia Pointe Grand Limited Partnership and Exelixis, Inc.
|
|
10-Q
|
|
000-30235
|
|
10.48
|
|
8/5/2004
|
|
|
10.38
|
|
First Amendment, dated February 28, 2003, to Lease, dated May 24, 2001, between Britannia Pointe Grand Limited Partnership and Exelixis, Inc.
|
|
S-1,
as amended
|
|
333-152166
|
|
10.46
|
|
7/7/2008
|
|
|
10.39
|
|
Second Amendment, dated July 20, 2004, to Lease, dated May 24, 2001, between Britannia Pointe Grand Limited Partnership and Exelixis, Inc.
|
|
10-Q
|
|
000-30235
|
|
10.49
|
|
8/5/2004
|
|
|
10.40
|
|
Lease Agreement, dated May 27, 2005, between Exelixis, Inc. and Britannia Pointe Grand Limited Partnership.
|
|
8-K
|
|
000-30235
|
|
10.1
|
|
5/27/2005
|
|
|
10.41
|
|
Sublease, dated July 25, 2011, between Exelixis, Inc. and Nodality, Inc.
|
|
10-Q
|
|
000-30235
|
|
10.3
|
|
10/27/2011
|
|
|
Exhibit
Number
|
|
Exhibit Description
|
|
Incorporation by Reference
|
|
Filed
Herewith
|
||||||
Form
|
|
File Number
|
|
Exhibit/
Appendix
Reference
|
|
Filing Date
|
|
|||||
10.42
|
|
Consent to Sublease, dated August 16, 2011, by and among HCP Life Science REIT, Inc., Exelixis, Inc., and Nodality, Inc.
|
|
10-Q
|
|
000-30235
|
|
10.4
|
|
10/27/2011
|
|
|
10.43
|
|
Side Letter dated April 12, 2012 to Sublease between Exelixis, Inc. and Nodality, Inc.
|
|
10-Q
|
|
000-30235
|
|
10.1
|
|
8/2/2012
|
|
|
10.44
|
|
First Amendment to Sublease dated effective June 1, 2012 by and between Exelixis, Inc. and Nodality, Inc.
|
|
10-Q
|
|
000-30235
|
|
10.2
|
|
8/2/2012
|
|
|
10.45
|
|
Consent of Landlord dated June 1, 2012 to First Amendment to Sublease dated effective June 1, 2012 by and between Exelixis, Inc. and Nodality, Inc.
|
|
10-Q
|
|
000-30235
|
|
10.3
|
|
8/2/2012
|
|
|
10.46
|
|
Second Amendment to Sublease dated effective July 1, 2015 by and between Exelixis, Inc. and Nodality, Inc.
|
|
10-Q
|
|
000-30235
|
|
10.2
|
|
8/11/2015
|
|
|
10.47
|
|
First Amendment to Consent to Sublease Agreement dated effective July 1, 2015 by and among Britannia Pointe Grand Limited Partnership, Exelixis, Inc. and Nodality, Inc.
|
|
10-Q
|
|
000-30235
|
|
10.3
|
|
8/11/2015
|
|
|
10.48
|
|
Sublease, dated July 25, 2011, between Exelixis, Inc. and Threshold Pharmaceuticals, Inc.
|
|
10-Q
|
|
000-30235
|
|
10.5
|
|
10/27/2011
|
|
|
10.49
|
|
Consent to Sublease, dated August 19, 2011, by and among HCP Life Science REIT, Inc., Exelixis, Inc., and Threshold Pharmaceuticals, Inc.
|
|
10-Q
|
|
000-30235
|
|
10.6
|
|
10/27/2011
|
|
|
10.50
|
|
First Amendment to Sublease dated effective October 1, 2013 by and between Exelixis, Inc. and Threshold Pharmaceuticals, Inc.
|
|
10-Q
|
|
000-30235
|
|
10.4
|
|
8/11/2015
|
|
|
10.51
|
|
First Amendment to Consent to Sublease Agreement dated effective October 1, 2013 by and among Britannia Pointe Grand Limited Partnership, Exelixis, Inc. and Threshold Pharmaceuticals, Inc.
|
|
10-Q
|
|
000-30235
|
|
10.5
|
|
8/11/2015
|
|
|
10.52
|
|
Second Amendment to Sublease dated effective July 1, 2015 by and between Exelixis, Inc. and Threshold Pharmaceuticals, Inc.
|
|
10-Q
|
|
000-30235
|
|
10.6
|
|
8/11/2015
|
|
|
10.53
|
|
Second Amendment to Consent to Sublease Agreement dated effective July 1, 2015 by and among Britannia Pointe Grand Limited Partnership, Exelixis, Inc. and Threshold Pharmaceuticals, Inc.
|
|
10-Q
|
|
000-30235
|
|
10.7
|
|
8/11/2015
|
|
|
10.54
|
|
Sublease Agreement, dated August 5, 2013, by and between Exelixis, Inc. and Sutro Biopharma, Inc.
|
|
10-Q
|
|
000-30235
|
|
10.2
|
|
10/30/2013
|
|
|
10.55
|
|
Consent to Sublease Agreement, dated August 5, 2013, by and among Britannia Pointe Limited Grand Partnership, Exelixis, Inc. and Sutro Biopharma, Inc.
|
|
10-Q
|
|
000-30235
|
|
10.3
|
|
10/30/2013
|
|
|
10.56
|
|
Loan and Security Agreement, dated May 22, 2002, by and between Silicon Valley Bank and Exelixis, Inc.
|
|
10-Q
|
|
000-30235
|
|
10.34
|
|
8/6/2002
|
|
|
Exhibit
Number
|
|
Exhibit Description
|
|
Incorporation by Reference
|
|
Filed
Herewith
|
||||||
Form
|
|
File Number
|
|
Exhibit/
Appendix
Reference
|
|
Filing Date
|
|
|||||
10.57
|
|
Loan Modification Agreement, dated December 21, 2004, between Silicon Valley Bank and Exelixis, Inc.
|
|
8-K
|
|
000-30235
|
|
10.1
|
|
12/23/2004
|
|
|
10.58
|
|
Amendment No. 7, dated December 21, 2006, to the Loan and Security Agreement, dated May 22, 2002, between Silicon Valley Bank and Exelixis, Inc.
|
|
8-K
|
|
000-30235
|
|
10.1
|
|
12/27/2006
|
|
|
10.59
|
|
Amendment No. 8, dated December 21, 2007, to the Loan and Security Agreement, dated May 22, 2002, between Silicon Valley Bank and Exelixis, Inc.
|
|
8-K
|
|
000-30235
|
|
10.1
|
|
12/26/2007
|
|
|
10.60
|
|
Amendment No. 9, dated December 22, 2009, to the Loan and Security Agreement, dated May 22, 2002, between Silicon Valley Bank and Exelixis, Inc.
|
|
8-K
|
|
000-30235
|
|
10.1
|
|
12/23/2009
|
|
|
10.61*
|
|
Amendment No. 10, dated June 2, 2010, to the Loan and Security Agreement, dated May 22, 2002, by and between Silicon Valley Bank and Exelixis, Inc.
|
|
10-Q
|
|
000-30235
|
|
10.3
|
|
8/5/2010
|
|
|
10.62*
|
|
Amendment No. 11, dated August 18, 2011, to the Loan and Security Agreement, dated May 22, 2002, by and between Silicon Valley Bank and Exelixis, Inc.
|
|
10-Q
|
|
000-30235
|
|
10.7
|
|
10/27/2011
|
|
|
10.63
|
|
Note Purchase Agreement, dated June 2, 2010, by and between Deerfield Private Design Fund, L.P., Deerfield Private Design International, L.P. and Exelixis, Inc.
|
|
10-Q
|
|
000-30235
|
|
10.1
|
|
8/5/2010
|
|
|
10.64
|
|
Consent and Amendment dated as of August 6, 2012 to Note Purchase Agreement, dated as of June 2, 2010, between Exelixis, Inc., Deerfield Private Design Fund, L.P. and Deerfield Private Design International, L.P.
|
|
8-K
|
|
000-30235
|
|
10.1
|
|
8/6/2012
|
|
|
10.65
|
|
Amendment No. 2 dated as of August 1, 2013 to Note Purchase Agreement, dated as of June 2, 2010, between Exelixis, Inc., Deerfield Private Design Fund, L.P. and Deerfield Private Design International, L.P.
|
|
10-Q
|
|
000-30235
|
|
10.1
|
|
10/30/2013
|
|
|
10.66
|
|
Amendment No. 3 dated as of January 22, 2013 to Note Purchase Agreement, dated as of June 2, 2010, by and among Exelixis, Inc., Deerfield Private Design Fund, L.P., Deerfield Private Design International, L.P., Deerfield Partners L.P. and Deerfield International Master Fund, L.P.
|
|
8-K
|
|
000-30235
|
|
10.1
|
|
1/22/2014
|
|
|
10.67
|
|
Amendment No. 4 dated as of July 10, 2014 to Note Purchase Agreement, dated as of June 2, 2010, by and among Exelixis, Inc., Deerfield Private Design Fund, L.P., Deerfield Private Design International, L.P., Deerfield Partners L.P. and Deerfield International Master Fund, L.P.
|
|
10-Q
|
|
000-30235
|
|
10.1
|
|
11/4/2014
|
|
|
Exhibit
Number
|
|
Exhibit Description
|
|
Incorporation by Reference
|
|
Filed
Herewith
|
||||||
Form
|
|
File Number
|
|
Exhibit/
Appendix
Reference
|
|
Filing Date
|
|
|||||
10.68
|
|
Security Agreement, dated July 1, 2010, by and between Deerfield Private Design Fund, L.P., Deerfield Private Design International, L.P. and Exelixis, Inc.
|
|
10-Q
|
|
000-30235
|
|
10.2
|
|
8/5/2010
|
|
|
10.69*
|
|
Collaboration Agreement, dated December 22, 2006, between Exelixis, Inc. and Genentech, Inc.
|
|
10-K
|
|
000-30235
|
|
10.39
|
|
2/27/2007
|
|
|
10.70*
|
|
First Amendment, dated March 13, 2008, to the Collaboration Agreement, dated December 22, 2006, between Exelixis, Inc. and Genentech, Inc.
|
|
10-Q
|
|
000-30235
|
|
10.1
|
|
5/6/2008
|
|
|
10.71
|
|
Second Amendment, dated April 30, 2010, to the Collaboration Agreement, dated December 22, 2006, between Exelixis, Inc. and Genentech, Inc.
|
|
10-Q
|
|
000-30235
|
|
10.5
|
|
8/5/2010
|
|
|
10.72*
|
|
License Agreement, dated May 27, 2009, between Exelixis, Inc. and Sanofi.
|
|
10-Q,
as amended
|
|
000-30235
|
|
10.1
|
|
7/30/2009
|
|
|
10.73*
|
|
Collaboration Agreement, dated May 27, 2009, between Exelixis, Inc. and Sanofi
|
|
10-Q
|
|
000-30235
|
|
10.1
|
|
7/31/2014
|
|
|
10.74
|
|
Letter, dated May 27, 2009, relating to regulatory filings for the Collaboration Agreement, dated May 27, 2009, between Exelixis, Inc. and Sanofi.
|
|
10-Q,
as amended
|
|
000-30235
|
|
10.3
|
|
7/30/2009
|
|
|
10.75*
|
|
Termination Agreement, dated December 22, 2011, between Exelixis, Inc. and Sanofi.
|
|
10-K
|
|
000-30235
|
|
10.83
|
|
2/22/2012
|
|
|
10.76*
|
|
Amended and Restated Collaboration Agreement, dated April 15, 2011, by and between Exelixis, Inc., Exelixis Patent Company, LLC., and Bristol-Myers Squibb Company.
|
|
10-Q
|
|
000-30235
|
|
10.6
|
|
8/4/2011
|
|
|
10.77*
|
|
Amended and Restated Collaboration Agreement, dated April 15, 2011, by and between Exelixis, Inc., Exelixis Patent Company, LLC., and Bristol-Myers Squibb Company.
|
|
10-Q
|
|
000-30235
|
|
10.5
|
|
8/4/2011
|
|
|
10.78*
|
|
Amended and Restated License Agreement, dated April 15, 2011, by and between Exelixis, Inc., Exelixis Patent Company, LLC, and Bristol-Myers Squibb Company.
|
|
10-Q
|
|
000-30235
|
|
10.7
|
|
8/4/2011
|
|
|
10.79*
|
|
Amended and Restated Collaboration Agreement, dated April 15, 2011, by and between Exelixis, Inc., Exelixis Patent Company, LLC, and Bristol-Myers Squibb Company.
|
|
10-Q
|
|
000-30235
|
|
10.8
|
|
8/4/2011
|
|
|
10.80*
|
|
Exclusive License Agreement, dated December 20, 2011, between Exelixis, Inc. and Merck.
|
|
10-K
|
|
000-30235
|
|
10.91
|
|
2/22/2012
|
|
|
12.1
|
|
Statement Re Computation of Earnings to Fixed Charges
|
|
|
|
|
|
|
|
|
|
X
|
21.1
|
|
Subsidiaries of Exelixis, Inc.
|
|
|
|
|
|
|
|
|
|
X
|
23.1
|
|
Consent of Independent Registered Public Accounting Firm.
|
|
|
|
|
|
|
|
|
|
X
|
24.1
|
|
Power of Attorney (contained on signature page).
|
|
|
|
|
|
|
|
|
|
X
|
Exhibit
Number
|
|
Exhibit Description
|
|
Incorporation by Reference
|
|
Filed
Herewith
|
||||||
Form
|
|
File Number
|
|
Exhibit/
Appendix
Reference
|
|
Filing Date
|
|
|||||
31.1
|
|
Certification required by Rule 13a-14(a) or Rule 15d-14(a).
|
|
|
|
|
|
|
|
|
|
X
|
31.2
|
|
Certification required by Rule 13a-14(a) or Rule 15d-14(a).
|
|
|
|
|
|
|
|
|
|
X
|
32.1‡
|
|
Certification by the Chief Executive Officer and the Chief Financial Officer of Exelixis, Inc., as required by Rule 13a-14(b) or 15d-14(b) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. 1350).
|
|
|
|
|
|
|
|
|
|
X
|
101.INS
|
|
XBRL Instance Document
|
|
|
|
|
|
|
|
|
|
X
|
101.SCH
|
|
XBRL Taxonomy Extension Schema Document
|
|
|
|
|
|
|
|
|
|
X
|
101.CAL
|
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
|
|
|
|
|
|
|
|
|
X
|
101.DEF
|
|
XBRL Taxonomy Extension Definition Linkbase
|
|
|
|
|
|
|
|
|
|
X
|
101.LAB
|
|
XBRL Taxonomy Extension Labels Linkbase Document
|
|
|
|
|
|
|
|
|
|
X
|
101.PRE
|
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
|
|
|
|
|
|
|
|
|
X
|
†
|
Management contract or compensatory plan.
|
*
|
Confidential treatment granted for certain portions of this exhibit.
|
‡
|
This certification accompanies this Annual Report on Form 10-K, is not deemed filed with the SEC and is not to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of this Annual Report on Form 10-K), irrespective of any general incorporation language contained in such filing.
|
|
Year Ended December 31,
|
||||||||||||||||||
|
2015
|
|
2014
|
|
2013
|
|
2012
|
|
2011
|
||||||||||
Fixed charges:
|
|
|
|
|
|
|
|
|
|
||||||||||
Interest expense
|
$
|
48,673
|
|
|
$
|
48,607
|
|
|
$
|
45,347
|
|
|
$
|
27,088
|
|
|
$
|
16,259
|
|
Interest portion of rental expense
|
755
|
|
|
886
|
|
|
935
|
|
|
2,948
|
|
|
606
|
|
|||||
Total fixed charges
|
$
|
49,428
|
|
|
$
|
49,493
|
|
|
$
|
46,282
|
|
|
$
|
30,036
|
|
|
$
|
16,865
|
|
Earnings:
|
|
|
|
|
|
|
|
|
|
||||||||||
Net (loss) income before income taxes
|
$
|
(169,682
|
)
|
|
$
|
(268,724
|
)
|
|
$
|
(244,856
|
)
|
|
$
|
(147,538
|
)
|
|
$
|
76,992
|
|
Fixed charges per above
|
49,428
|
|
|
49,493
|
|
|
46,282
|
|
|
30,036
|
|
|
16,865
|
|
|||||
Earnings
|
$
|
(120,254
|
)
|
|
$
|
(219,049
|
)
|
|
$
|
(198,574
|
)
|
|
$
|
(117,502
|
)
|
|
$
|
93,857
|
|
Ratio of earnings to fixed charges
|
|
|
|
|
|
|
|
|
5.57
|
|
|||||||||
Deficiency of earnings available to cover fixed charges
|
$
|
(169,682
|
)
|
|
$
|
(268,724
|
)
|
|
$
|
(244,856
|
)
|
|
$
|
(147,538
|
)
|
|
|
Name of Subsidiary
|
State or Other Jurisdiction of Incorporation or Organization
|
Exelixis Global Services, Inc.
|
Delaware
|
Exelixis International (Bermuda) Ltd.
|
Bermuda
|
Exelixis International (UK) Ltd.
|
United Kingdom
|
Exelixis Patent Company, LLC
|
Delaware
|
Exelixis Plant Sciences, Inc.
|
Delaware
|
/s/ M
ICHAEL
M. M
ORRISSEY
|
Michael M. Morrissey, Ph.D.
|
President and Chief Executive Officer
(Principal Executive Officer)
|
/s/ C
HRISTOPHER
J. S
ENNER
|
Christopher J. Senner
|
Executive Vice President and Chief Financial Officer
(Principal Financial Officer)
|
/s/ M
ICHAEL
M. M
ORRISSEY
|
|
|
|
/s/ C
HRISTOPHER
J. S
ENNER
|
Michael M. Morrissey, Ph.D.
|
|
|
|
Christopher J. Senner
|
President and Chief Executive Officer
(Principal Executive Officer)
|
|
|
|
Executive Vice President and Chief Financial Officer
(Principal Financial Officer)
|