FORM 10-K
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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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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Large accelerated filer
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ý
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Accelerated filer
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¨
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Non-accelerated filer
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¨
(Do not check if a smaller reporting company)
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Smaller reporting company
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Emerging growth company
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¨
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CABOMETYX (cabozantinib)
was first approved by the U.S. Food and Drug Administration, or FDA, on April 25, 2016, for the treatment of patients with advanced RCC who have received prior anti-angiogenic therapy and by the European Com
mission, or EC, on September 9, 2016, similarly for the treatment of advanced RCC in adults following prior VEGF targeted therapy
. On December 19, 2017, the FDA approved the expanded indication for CABOMETYX to include previously untreated patients with advanced RCC, and o
n September 8, 2017, the European Medicines Agency, or EMA, validated the regulatory dossier for cabozantinib as a treatment for patients with previously untreated advanced RCC in the European Union, or EU. Outside the U.S. and Japan, CABOMETYX is marketed by our collaboration partner Ipsen Pharma SAS, or Ipsen. Should CABOMETYX be approved in Japan, it would be marketed by our collaboration partner Takeda Pharmaceutical Company Limited, or Takeda. In 2017, we generated
$323.1 million
in net product revenues from sales of CABOMETYX in the U.S.
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COMETRIQ (cabozantinib)
, our first marketed product, was approved by the FDA on November 29, 2012, for the treatment of patients with progressive, metastatic MTC. In March 2014, the EC granted COMETRIQ a similar, conditional marketing authorization for the treatment of adult patients with progressive, unresectable locally advanced or metastatic MTC. COMETRIQ is commercialized in the EU by Ipsen. In 2017, we generated
$25.0 million
in net product revenues from sales of COMETRIQ in the U.S.
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COTELLIC
(cobimetinib)
was approved by the FDA on November 10, 2015, in combination with vemurafenib for the treatment of patients with BRAF V600E or V600K mutation-positive advanced melanoma in the U.S. It has also been approved in combination with vemurafenib in multiple other territories including the EU, Switzerland, Canada, Australia and Brazil. In 2017, we recognized
$6.4 million
of
royalties on ex-U.S. sales of COTELLIC and recorded a net loss of $2.1 million related to our profit share from sales of COTELLIC in the U.S. under our collaboration agreement with Genentech. Cobimetinib is being evaluated in a broad development program consisting of more than 50 trials by Genentech. For additional information on the cobimetinib development program, see “Cobimetinib Development Program
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”
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CLINICAL DEVELOPMENT PROGRAM FOR CABOZANTINIB, SINGLE-AGENT
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Indication
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Status Update
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Thyroid Cancer
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Progressive, metastatic medullary thyroid cancer
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Approved in U.S. and EU (EXAM)
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Progressive, metastatic medullary thyroid cancer
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Post-marketing study (EXAMINER)
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Differentiated thyroid cancer
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Phase 2*
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Renal Cell Carcinoma (RCC)
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Second- and later-line advanced RCC
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Approved in U.S. and EU (METEOR)
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Advanced RCC (including previously untreated RCC)
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Approved in U.S. on December 19, 2017; filing accepted in EU, currently under regulatory review (CABOSUN)
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First- or second-line papillary RCC
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Randomized phase 2† (PAPMET)
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Hepatocellular Carcinoma (HCC)
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Second- and later-line advanced HCC
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Phase 3 pivotal trial (CELESTIAL) positive results; sNDA filing planned for Q1 2018 and EMA filing planned for 1H 2018 (Ipsen)
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Non-Small Cell Lung Cancer (NSCLC)
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EGFR wild-type
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Phase 2†
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Molecular alterations in RET, ROS1, MET, AXL, or NTRK1
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Phase 2*
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Additional Trials
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Metastatic urothelial cancer
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Phase 2 *
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Breast cancer with brain metastases
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Phase 2*
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Colorectal cancer
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Phase 1*
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High-grade uterine sarcomas
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Phase 2 §
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Metastatic gastrointestinal stromal tumor
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Phase 2 (CABOGIST)§
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Pancreatic neuroendocrine tumors and carcinoid tumors
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Phase 2†
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Plexiform neurofibromas (pediatric and adult cohorts)
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Phase 2*
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Relapsed osteosarcoma or Ewing sarcoma
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Phase 2†
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Soft-tissue sarcomas
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Phase 2†
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*
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Trial conducted through our IST program.
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†
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Trial conducted through collaboration with NCI-CTEP.
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§
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Trial sponsored by the European Organization for Research and Treatment of Cancer.
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*
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Trial conducted through our IST program.
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†
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Trial conducted through collaboration with NCI-CTEP.
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§
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Trial sponsored by the European Organization for Research and Treatment of Cancer.
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patients with advanced non-squamous NSCLC without a defined tumor genetic alteration (EGFR, ALK, ROS1, or BRAF) who have not received prior therapy with an immune checkpoint inhibitor;
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patients with NSCLC without a defined tumor genetic alteration who have progressed following treatment with an immune checkpoint inhibitor;
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patients with UC who have progressed following treatment with an immune checkpoint inhibitor;
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patients with CRPC who have previously received enzalutamide and/or abiraterone acetate and experienced radiographic disease progression in soft tissue;
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patients with RCC with clear cell histology who have not had prior systemic anticancer therapy;
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patients with UC who have progressed on or after platinum-containing chemotherapy;
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patients with UC who are ineligible for cisplatin-based chemotherapy and have not received prior systemic chemotherapy for inoperable, locally advanced or metastatic disease; and
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patients with UC who are eligible for cisplatin-based chemotherapy and have not received prior systemic chemotherapy for inoperable, locally advanced or metastatic disease.
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the combination of cobimetinib and vemurafenib in additional melanoma patient populations and settings;
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a phase 2 trial of cobimetinib in combination with taxanes, with or without atezolizumab in first-line triple negative breast cancer (COLET);
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Phase 2 studies of cobimetinib in combination with atezolizumab in RCC,
head and neck squamous cell carcinoma,
UC and hormone receptor positive, HER2 negative breast cancer;
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Phase 1/2 studies of cobimetinib in combination with atezolizumab in melanoma and NSCLC, in combination with vemurafenib and atezolizumab in melanoma, and in combination with venetoclax in relapsed or refractory acute myeloid leukemia and multiple myeloma;
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a phase 1b study evaluating the safety, tolerability and pharmacokinetics of cobimetinib in combination with atezolizumab and bevacizumab in patients with metastatic CRC; and
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a phase 1b/2 study of cobimetinib in combination with atezolizumab (one arm of a randomized umbrella study) in metastatic pancreatic ductal adenocarcinoma.
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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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submission of a New Drug Application, or NDA, to FDA for commercial marketing, or of a sNDA, for approval of a new indication if the product is already approved for another indication;
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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;
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if FDA convenes an advisory committee, satisfactory completion of the advisory committee review; and
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FDA approval of the NDA or sNDA.
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Phase 1 - Studi
es, which involve the initial introduction of an IND into humans, are initially conducted in a limited number of subjects 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. Phase 2 studies are typically well controlled, closely monitored, and conducted in a relatively small number of patients, usually involving no more than several hundred subjects. 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, p
hase 3 trials are performed to gather the additional information about effectiveness
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require the FDA t
o establish a program to evaluate the potential use of real world evidence to help to support the approval of a new indication for an approved drug and to help to support or satisfy post-approval study requirements;
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provide that the FDA may rely upon qualified data summaries to support the approval of a supplemental application with respect to a qualified indication for an already approved drug;
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require FDA to issue guidance for purposes of assisting sponsors in incorporating complex adaptive and other novel trial designs into proposed clinical protocols and applications for new drugs; and
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require FDA to establish a process for the qualification of drug development tools for use in supporting or obtaining FDA approval for or investigational
use of a drug.
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efficacy, safety and reliab
ility 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 its approved indications;
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our ability to complete clinical development and obtain regulatory approvals for cabozantinib;
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our ability to manufacture and sell commercial quantities of cabozantinib product 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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the level of our collaboration partners’ investments in the resources necessary to successfully commercialize cabozantinib in territories where it is approved outside of the U.S.;
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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 subs
tantial capital resources to fund development and commercialization activities.
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the effectiveness, or perceived effectiveness, of CABOMETYX in comparison to competing products;
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the safety of CABOMETYX, including the existence of serious side effects of CABOMETYX and their severity in comparison to those of competing products;
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CABOMETYX’s relative convenience and ease of administration;
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potential unexpected results connected with analysis of data from future or ongoing clinical trials of cabozantinib;
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the timing of CABOMETYX label expansions for additional indications, if any, relative to competitive treatments;
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the price of CABOMETYX relative to competitive therapies and any new government initiatives affecting pharmaceutical pricing;
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the strength of CABOMETYX sales efforts, marketing, medical affairs and distribution support;
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the sufficiency of commercial and government insurance coverage and reimbursement for CABOMETYX; and
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our ability to enforce our intellectual property rights with respect to CABOMETYX.
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the federal Anti-Kickback Statute, or AKS, which governs our business activities, including our marketing practices, educational programs, pricing policies, and relationships with healthcare providers or other entities.
The AKS has been broadly interpreted to apply to manufacturer arrangements with prescribers, purchasers and formulary managers, among others.
Among other things, this statute prohibits 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. Remuneration is not defined in the AKS and has been broadly interpreted to include anything of value, including for example, gifts, discounts, coupons, the furnishing of supplies or equipment, credit arrangements, payments of cash, waivers of payments, ownership interests and providing anything at less than its fair market value;
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the FDCA and its regulations, which prohibit, among other things, the introduction or delivery for introduction into interstate commerce of any drug that is adulterated or misbranded;
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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, or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government;
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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 and its 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 governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts;
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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) and its foreign equivalents;
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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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federal and state government price reporting laws, which require us to calculate and report complex pricing metrics to government programs, where such reported prices may be used in the calculation of reimbursement and/or discounts on our marketed drugs, as well as certain state and municipal government price reporting laws that require us to provide justifications where drug prices exceed a certain price increase threshold (and participation in these programs and compliance with the applicable requirements may subject us to potentially significant discounts on our products, increased infrastructure costs, and could potentially affect our ability to offer certain marketplace discounts); and
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federal and state financial and drug pricing transparency laws, which generally require certain types of expenditures in the U.S. to be tracked and reported (and 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 with healthcare providers and healthcare entities, which could potentially have a negative effect on our business and/or increase enforcement scrutiny of our activities).
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lack of efficacy or 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 our product candidates;
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our inability to identify and maintain a sufficient number of trial sites, many of which may already be engaged in other clinical trial programs;
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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;
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failure by our collaborators to provide us on a timely basis with an adequate supply of product that complies with the applicable quality and regulatory requirements for a combination trial;
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failure of our third-party contract research organization or investigators to satisfy their contractual obligations, including deviating from trial protocol; and
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regulators or institutional review boards may withhold authorization to commence or conduct clinical trials of a product candidate, 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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the commercial success of both CABOMETYX and COMETRIQ and the revenues we generate from those approved products;
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costs associated with maintaining our expanded sales, marketing, medical affairs and distribution capabilities for CABOMETYX and COMETRIQ;
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the achievement of stated regulatory and commercial milestones under our collaboration agreements with Ipsen and Takeda;
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the commercial success of COTELLIC and the revenues generated through 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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our ability to timely prepare and submit an sNDA for cabozantinib as a treatment for patients with previously treated advanced HCC;
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future clinical trial results;
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our future investments in the expansion of our pipeline through drug discovery and corporate development activities;
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our ability to control costs;
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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 U.S. 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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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 costs we are obligated to share, in part, under our collaboration agreement with Genentech;
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collaborators may delay clinical trials, fail to supply us on a timely basis with the product required for a combination trial, 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 commercial success of both CABOMETYX and COMETRIQ and the revenues we generate from those approved products;
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customer ordering patterns for CABOMETYX and COMETRIQ, which may vary significantly from period to period;
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the overall level of demand for CABOMETYX and COMETRIQ, including the impact of any competitive products and the duration of therapy for patients receiving CABOMETYX or COMETRIQ;
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the commercial success of COTELLIC and the revenues generated through 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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changes in the amount of deductions from gross sales,
including changes to the discount percentage of rebates and chargebacks mandated by the government programs in which we participate
, including increases in the government discount percentage resulting from price increases we have taken or may take in the future, or due to different levels of utilization by entities entitled to government rebates and chargebacks and changes in patient demographics;
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costs associated with maintaining our sales, marketing, medical affairs and distribution capabilities for CABOMETYX, COMETRIQ and COTELLIC;
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our ability to timely prepare and submit an sNDA for cabozantinib as a treatment for patients with previously treated advanced HCC;
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the achievement of stated regulatory and commercial milestones, under our collaboration agreements;
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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;
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our future investments in the expansion of our pipeline through drug discovery and corporate development activities;
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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 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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additions and departures of key personnel;
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significant fluctuations in interest rates or foreign currency exchange rates;
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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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the announcement of FDA approval or non-approval, or delays in the FDA review process with respect to cabozantinib, our collaborators’ product candidates being developed in combination with cabozantinib, or our competitors’ product candidates;
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the commercial success of both CABOMETYX and COMETRIQ and the revenues we generate from those approved products;
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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, both in the U.S. and abroad, with respect to cabozantinib or our clinical trials for cabozantinib;
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unanticipated regulatory actions taken by the FDA as a result of changing FDA standards and practices concerning the review of product candidates at earlier stages of clinical development or with lesser developed data sets and the speed with which the FDA is conducting regulatory reviews
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the announcement of new products by our competitors;
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the announcement of regulatory applications seeking a path to U.S. approval of generic versions of our marketed products;
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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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the announcement of an in-licensed product candidate or strategic acquisition;
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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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the entry into new financing arrangements;
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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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the extent to which coverage and reimbursement is available for both CABOMETYX and COMETRIQ from government and health administration authorities, private health insurers, managed care programs and other third-party payers;
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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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The first lease covers two buildings in South San Francisco, California with a total area of 116,063 square feet and expires in July 2018.
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The second lease covers three buildings in Alameda, California with a total area of
130,561
square feet and expires in January 2028.
We have
two
five
-year options to extend the lease and a
one
-time option to terminate the lease without cause on the last day of the 8
th
year of the initial term.
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Common Stock Price
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High
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Low
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Year ended December 29, 2017:
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Quarter ended March 31, 2017
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$
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23.49
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$
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14.22
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Quarter ended June 30, 2017
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$
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25.22
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$
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18.03
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Quarter ended September 29, 2017
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$
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29.50
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$
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23.18
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Quarter ended December 29, 2017
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$
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32.50
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$
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23.85
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Year ended December 30, 2016:
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|
|
||||
Quarter ended April 1, 2016
|
$
|
5.85
|
|
|
$
|
3.55
|
|
Quarter ended July 1, 2016
|
$
|
8.19
|
|
|
$
|
4.11
|
|
Quarter ended September 30, 2016
|
$
|
15.58
|
|
|
$
|
7.93
|
|
Quarter ended December 30, 2016
|
$
|
18.29
|
|
|
$
|
10.04
|
|
|
December 31,
|
||||||||||||||||
|
2012
|
|
2013
|
|
2014
|
|
2015
|
|
2016
|
|
2017
|
||||||
Exelixis, Inc.
|
100
|
|
|
131
|
|
|
37
|
|
|
125
|
|
|
331
|
|
|
674
|
|
Nasdaq Market Index
|
100
|
|
|
140
|
|
|
160
|
|
|
169
|
|
|
182
|
|
|
233
|
|
Nasdaq Biotechnology Index
|
100
|
|
|
168
|
|
|
228
|
|
|
251
|
|
|
197
|
|
|
238
|
|
|
Year Ended December 31,
|
||||||||||||||||||
|
2017
|
|
2016
|
|
2015
|
|
2014
|
|
2013
|
||||||||||
|
(In thousands, except per share data)
|
||||||||||||||||||
Consolidated Statements of Operations Data:
|
|
|
|
|
|
|
|
|
|
||||||||||
Revenues
|
$
|
452,477
|
|
|
$
|
191,454
|
|
|
$
|
37,172
|
|
|
$
|
25,111
|
|
|
$
|
31,338
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
||||||||||
Cost of goods sold
|
15,066
|
|
|
6,552
|
|
|
3,895
|
|
|
2,043
|
|
|
1,118
|
|
|||||
Research and development
|
112,171
|
|
|
95,967
|
|
|
96,351
|
|
|
189,101
|
|
|
178,763
|
|
|||||
Selling, general and administrative
|
159,362
|
|
|
116,145
|
|
|
57,305
|
|
|
50,829
|
|
|
50,958
|
|
|||||
Restructuring (recovery) charge
|
(32
|
)
|
|
914
|
|
|
1,042
|
|
|
7,596
|
|
|
1,231
|
|
|||||
Total operating expenses
|
286,567
|
|
|
219,578
|
|
|
158,593
|
|
|
249,569
|
|
|
232,070
|
|
|||||
Income (loss) from operations
|
165,910
|
|
|
(28,124
|
)
|
|
(121,421
|
)
|
|
(224,458
|
)
|
|
(200,732
|
)
|
|||||
Other income (expenses), net
|
(7,333
|
)
|
|
(42,098
|
)
|
|
(40,268
|
)
|
|
(37,021
|
)
|
|
(37,556
|
)
|
|||||
Income (loss) before income taxes
|
158,577
|
|
|
(70,222
|
)
|
|
(161,689
|
)
|
|
(261,479
|
)
|
|
(238,288
|
)
|
|||||
Income tax provision (benefit)
|
4,350
|
|
|
—
|
|
|
55
|
|
|
(182
|
)
|
|
(96
|
)
|
|||||
Net income (loss)
|
$
|
154,227
|
|
|
$
|
(70,222
|
)
|
|
$
|
(161,744
|
)
|
|
$
|
(261,297
|
)
|
|
$
|
(238,192
|
)
|
Net income (loss) per share, basic
|
$
|
0.52
|
|
|
$
|
(0.28
|
)
|
|
$
|
(0.77
|
)
|
|
$
|
(1.34
|
)
|
|
$
|
(1.29
|
)
|
Net income (loss) per share, diluted
|
$
|
0.49
|
|
|
$
|
(0.28
|
)
|
|
$
|
(0.77
|
)
|
|
$
|
(1.34
|
)
|
|
$
|
(1.29
|
)
|
Shares used in computing net income (loss) per share, basic
|
293,588
|
|
|
250,531
|
|
|
209,227
|
|
|
194,299
|
|
|
184,062
|
|
|||||
Shares used in computing net income (loss) per share, diluted
|
312,003
|
|
|
250,531
|
|
|
209,227
|
|
|
194,299
|
|
|
184,062
|
|
|
December 31,
|
||||||||||||||||||
|
2017
|
|
2016
|
|
2015
|
|
2014
|
|
2013
|
||||||||||
|
(In thousands)
|
||||||||||||||||||
Consolidated Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
||||||||||
Cash and investments
|
$
|
457,176
|
|
|
$
|
479,554
|
|
|
$
|
253,310
|
|
|
$
|
242,760
|
|
|
$
|
415,862
|
|
Working capital (deficit)
|
$
|
369,704
|
|
|
$
|
200,215
|
|
|
$
|
126,414
|
|
|
$
|
(3,188
|
)
|
|
$
|
178,756
|
|
Total assets
|
$
|
655,294
|
|
|
$
|
595,739
|
|
|
$
|
332,223
|
|
|
$
|
323,256
|
|
|
$
|
497,940
|
|
Long-term obligations
|
$
|
255,163
|
|
|
$
|
237,635
|
|
|
$
|
420,897
|
|
|
$
|
312,163
|
|
|
$
|
395,599
|
|
Accumulated deficit
|
$
|
(1,829,172
|
)
|
|
$
|
(1,983,147
|
)
|
|
$
|
(1,912,925
|
)
|
|
$
|
(1,751,181
|
)
|
|
$
|
(1,489,884
|
)
|
Total stockholders’ equity (deficit)
|
$
|
284,961
|
|
|
$
|
89,318
|
|
|
$
|
(140,806
|
)
|
|
$
|
(159,324
|
)
|
|
$
|
14,498
|
|
•
|
In January 2017, we entered into a collaboration and license agreement with Takeda for the commercialization and further clinical development of cabozantinib in Japan. Pursuant to the terms of the collaboration agreement, Takeda received exclusive commercialization rights for current and potential future cabozantinib indications in Japan.
|
•
|
In February 2017, we entered into a clinical trial collaboration agreement with BMS for the purpose of examining cabozantinib’s potential in combination with immunotherapies. Pursuant to this collaboration, in July 2017, we initiated CheckMate 9ER, a phase 3 pivotal trial evaluating the combination of cabozantinib with nivolumab in previously untreated, advanced or metastatic RCC. We also initiated CheckMate 040 in July 2017,
|
•
|
In February 2017, we entered into a clinical trial collaboration with Roche pursuant to which are evaluating cabozantinib and atezolizumab in locally advanced or metastatic solid tumors and in June 2017, we initiated a phase 1b trial evaluating this combination in patients with advanced genitorurinary malignancies, including RCC and UC. The trial is divided in two parts: a dose-escalation phase and an expansion cohort phase.
The primary objective is to determine
the optimal dose and schedule of daily oral administration of cabozantinib when given in combination with atezolizumab to inform the trial’s subsequent expansion stage. We subsequently amended the protocol in January 2018 to add four new expansion cohorts to the trial, which will now also include patients with NSCLC and CRPC in addition to previously included patients with RCC and UC.
|
•
|
In May 2017, we entered into a lease agreement for an aggregate of
110,783
square feet of space in office and research facilities in Alameda, California, which will become our corporate headquarters in 2018. The lease agreement was amended in October 2017 to include an additional
19,778
square feet.
|
•
|
In July 2017, we entered into an amendment to our collaboration agreement with Genentech in connection with the
final resolution of claims asserted in an arbitration proceeding by us against Genentech related to the development, pricing and commercialization of COTELLIC
.
The amendment provides for a favorably revised revenue and cost-sharing arrangement, that became effective as of July 1, 2017, and that is applicable to current and all potential future commercial uses of COTELLIC
.
|
•
|
In September 2017, Ipsen received validation from the EMA for the application for variation to the CABOMETYX marketing authorization for the addition of a new indication in previously untreated, advanced or metastatic RCC in adults.
|
•
|
In September 2017, we announced that our partner Daiichi Sankyo reported positive top-line results from ESAX-HTN, a phase 3 pivotal trial of esaxerenone, a product of the companies’ prior research collaboration, in patients with essential hypertension in Japan. With the trial achieving its primary endpoint, Daiichi Sankyo communicated its intention to submit a Japanese regulatory application for esaxerenone for an essential hypertension indication in the first quarter of 2018.
|
•
|
In October 2017, we announced that BMS filed a Clinical Trial Authorization in Europe for a first-in-human study of a RORγ inverse agonist.
|
•
|
In October 2017, we announced that CELESTIAL met its primary endpoint of OS, with cabozantinib providing a statistically significant and clinically meaningful improvement in OS compared to placebo in patients with previously treated advanced HCC. Median OS was 10.2 months with cabozantinib versus 8.0 months with placebo (HR 0.76; 95% CI 0.63-0.92; p=0.0049).
Based on these results, we plan to submit an sNDA to the FDA in the first quarter of 2018 for CABOMETYX as a treatment for patients with previously treated advanced HCC. Ipsen has informed us that it intends to submit a regulatory dossier for CABOMETYX as a treatment for patients with previously treated advanced HCC to the EMA in the first half of 2018.
|
•
|
In December 2017, following a priority review and approximately two months ahead of the assigned PDUFA target action date, the FDA approved CABOMETYX for the expanded indication of patients with previously untreated advanced RCC, the most common form of kidney cancer
in adults.
The FDA’s priority review and early approval of CABOMETYX was based on results from the randomized phase 2 CABOSUN trial in patients with previously untreated RCC, which demonstrated a statistically significant and clinically meaningful improvement in PFS versus sunitinib, a current standard of care.
|
•
|
In February 2018, we announced updated results from the NCI-CTEP-sponsored phase 1 trial of cabozantinib in combination with nivolumab, with or without ipilimumab, in patients with refractory genitourinary tumors. The updated results demonstrated an acceptable tolerability profile and high rates of durable responses in the previously treated metastatic UC and metastatic RCC cohorts.
|
•
|
In February 2018, updated data from a phase 2 IST of cabozantinib in patients with previously untreated radioiodine-refractory differentiated thyroid carcinoma, or DTC,
was presented at the 2018 Multidisciplinary Head and Neck Cancers Symposium. Based on the encouraging efficacy results and manageable safety profile in this phase 2 trial and other prior phase 2 trials in previously treated DTC, we plan to initiate a phase 3 pivotal trial evaluating cabozantinib as a treatment for patients with advanced DTC in 2018.
|
•
|
Our net product revenues increased by
$213.6 million
, or
158%
, to
$349.0 million
in 2017 compared to 2016, which primarily
reflects the growth in product sales of CABOMETYX since the product’s launch in late April 2016 and an increase in market share
.
|
•
|
Our collaboration revenues increased by
$47.4 million
, or
85%
, to
$103.5 million
in 2017 compared to 2016, primarily due to increases in milestone,
license, development, royalty and product supply revenues recognized under our collaboration agreements
.
|
•
|
Between March 2017 and June 2017, we repaid our $80.0 million term loan with Silicon Valley Bank and retired the Deerfield Notes in consideration for a payment of
$123.8 million
. For additional information on the repayment of our term loan with Silicon Valley Bank and the retirement of the Deerfield Notes, see “Note 6. Debt” to our “Notes to Consolidated Financial Statements” contained in Part II, Item 8 of this Annual Report on Form 10-K.
|
•
|
Cash and investments decreased to
$457.2 million
at
December 31, 2017
as compared to
$479.6 million
at
December 31, 2016
primarily due to the payoff of in debt, described above, offset by the increase in product and collaboration revenue
.
|
|
Year Ended December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
Product revenues:
|
|
|
|
|
|
||||||
Gross product revenues
|
$
|
402,569
|
|
|
$
|
151,499
|
|
|
$
|
36,650
|
|
Discounts and allowances
|
(53,561
|
)
|
|
(16,124
|
)
|
|
(2,492
|
)
|
|||
Net product revenues
|
349,008
|
|
|
135,375
|
|
|
34,158
|
|
|||
Collaboration revenues:
|
|
|
|
|
|
||||||
Contract revenues
(1)
|
57,500
|
|
|
40,000
|
|
|
3,000
|
|
|||
License revenues
(2)
|
28,908
|
|
|
13,284
|
|
|
—
|
|
|||
Development cost reimbursements
|
8,737
|
|
|
—
|
|
|
—
|
|
|||
Royalty and product supply revenues, net
|
8,324
|
|
|
2,795
|
|
|
14
|
|
|||
Total collaboration revenues
|
103,469
|
|
|
56,079
|
|
|
3,014
|
|
|||
Total revenues
|
$
|
452,477
|
|
|
$
|
191,454
|
|
|
$
|
37,172
|
|
Dollar change
|
$
|
261,023
|
|
|
$
|
154,282
|
|
|
|
||
Percentage change
|
136
|
%
|
|
415
|
%
|
|
|
(1)
|
Includes milestone payments.
|
(2)
|
Includes amortization of upfront payments.
|
|
Year Ended December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
CABOMETYX
|
$
|
324,000
|
|
|
$
|
93,481
|
|
|
$
|
—
|
|
COMETRIQ
|
25,008
|
|
|
41,894
|
|
|
34,158
|
|
|||
Net product revenues
|
$
|
349,008
|
|
|
$
|
135,375
|
|
|
$
|
34,158
|
|
Dollar change
|
$
|
213,633
|
|
|
$
|
101,217
|
|
|
|
||
Percentage change
|
158
|
%
|
|
296
|
%
|
|
|
|
Year Ended December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
Diplomat Specialty Pharmacy
|
$
|
83,059
|
|
|
$
|
63,826
|
|
|
$
|
30,856
|
|
Caremark L.L.C.
|
73,921
|
|
|
17,746
|
|
|
—
|
|
|||
Ipsen
|
69,792
|
|
|
33,252
|
|
|
—
|
|
|||
Accredo Health, Incorporated
|
50,716
|
|
|
16,631
|
|
|
—
|
|
|||
Affiliates of McKesson Corporation
|
48,662
|
|
|
13,143
|
|
|
—
|
|
|||
Others, individually less than 10% of total revenues for all periods presented
|
126,327
|
|
|
46,856
|
|
|
6,316
|
|
|||
Total revenues
|
$
|
452,477
|
|
|
$
|
191,454
|
|
|
$
|
37,172
|
|
|
Year Ended December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
Cost of goods sold
|
$
|
15,066
|
|
|
$
|
6,552
|
|
|
$
|
3,895
|
|
Gross margin
|
96
|
%
|
|
95
|
%
|
|
89
|
%
|
|
Year Ended December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
Research and development expenses
|
$
|
112,171
|
|
|
$
|
95,967
|
|
|
$
|
96,351
|
|
Dollar change
|
$
|
16,204
|
|
|
$
|
(384
|
)
|
|
|
||
Percentage change
|
17
|
%
|
|
less than 1%
|
|
|
|
|
Year Ended December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
Research and development expenses:
|
|
|
|
|
|
||||||
Development:
|
|
|
|
|
|
||||||
Clinical trial costs
|
$
|
40,315
|
|
|
$
|
35,947
|
|
|
$
|
44,859
|
|
Personnel expenses
|
30,076
|
|
|
22,936
|
|
|
12,655
|
|
|||
Consulting and outside services
|
8,492
|
|
|
8,176
|
|
|
6,203
|
|
|||
Other development costs
|
12,967
|
|
|
11,478
|
|
|
9,352
|
|
|||
Total development
|
91,850
|
|
|
78,537
|
|
|
73,069
|
|
|||
Drug discovery
(1)
|
6,334
|
|
|
1,220
|
|
|
571
|
|
|||
Other
(2)
|
13,987
|
|
|
16,210
|
|
|
22,711
|
|
|||
Total research and development expenses
|
$
|
112,171
|
|
|
$
|
95,967
|
|
|
$
|
96,351
|
|
(1)
|
Includes primarily personnel expenses, consulting and outside services, and laboratory supplies.
|
(2)
|
Includes stock-based compensation and the allocation of general corporate costs to research and development.
|
|
Year Ended December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
Selling, general and administrative expenses
|
$
|
159,362
|
|
|
$
|
116,145
|
|
|
$
|
57,305
|
|
Dollar change
|
$
|
43,217
|
|
|
$
|
58,840
|
|
|
|
||
Percentage change
|
37
|
%
|
|
103
|
%
|
|
|
|
Year Ended December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
Interest income
|
$
|
4,883
|
|
|
$
|
2,578
|
|
|
$
|
793
|
|
Interest expense
|
(8,679
|
)
|
|
(33,060
|
)
|
|
(40,680
|
)
|
|||
Other, net
|
(3,537
|
)
|
|
(11,616
|
)
|
|
(381
|
)
|
|||
Total other expenses, net
|
$
|
(7,333
|
)
|
|
$
|
(42,098
|
)
|
|
$
|
(40,268
|
)
|
Dollar change
|
$
|
34,765
|
|
|
$
|
(1,830
|
)
|
|
|
||
Percentage change
|
(83
|
)%
|
|
5
|
%
|
|
|
|
Year Ended December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
Income tax expense
|
$
|
4,350
|
|
|
$
|
—
|
|
|
$
|
55
|
|
|
Year Ended December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
Net income (loss)
|
$
|
154,227
|
|
|
$
|
(70,222
|
)
|
|
$
|
(161,744
|
)
|
Adjustments to reconcile net income (loss) to net cash provided by operating activities
|
18,330
|
|
|
53,359
|
|
|
46,538
|
|
|||
Changes in operating assets and liabilities
|
(6,946
|
)
|
|
227,267
|
|
|
(25,845
|
)
|
|||
Net cash provided by (used in) operating activities
|
165,611
|
|
|
210,404
|
|
|
(141,051
|
)
|
|||
Net cash provided by (used in) investing activities
|
35,795
|
|
|
(216,048
|
)
|
|
50,077
|
|
|||
Net cash (used in) provided by financing activities
|
(169,928
|
)
|
|
15,696
|
|
|
152,213
|
|
|||
Net increase in cash and cash equivalents
|
31,478
|
|
|
10,052
|
|
|
61,239
|
|
|||
Cash and cash equivalents at beginning of year
|
151,686
|
|
|
141,634
|
|
|
80,395
|
|
|||
Cash and cash equivalents at end of year
|
$
|
183,164
|
|
|
$
|
151,686
|
|
|
$
|
141,634
|
|
|
|
Payments Due by Period
|
||||||||||||||
Contractual Obligations
(1)
|
|
Total
|
|
Less than
1 year
|
|
1-3
Years
|
|
More than 3
years
|
||||||||
Operating leases
(2)
|
|
$
|
9,340
|
|
|
$
|
2,864
|
|
|
$
|
1,348
|
|
|
$
|
5,128
|
|
Other financing obligations
(2)
|
|
21,493
|
|
|
800
|
|
|
4,034
|
|
|
16,659
|
|
||||
Purchase and other long-term obligations
(3)
|
|
29,331
|
|
|
28,033
|
|
|
1,298
|
|
|
—
|
|
||||
Total contractual cash obligations
|
|
$
|
60,164
|
|
|
$
|
31,697
|
|
|
$
|
6,680
|
|
|
$
|
21,787
|
|
(1)
|
This table does not include potential future royalty obligations to GSK as the amount of such royalty obligations are not estimable.
|
(2)
|
Other financing obligations are related to our build-to-suit lease of office and research facilities located in Alameda, California. For a description of our obligations under our leases, see “Note 12. Commitments” in the “Notes to Consolidated Financial Statements” contained in Part II, Item 8 of this Annual Report on Form 10-K.
|
(3)
|
Purchase obligations due in 2018 include an obligation, which was capped at $20.9 million, for additional construction costs at our new office and research facilities in Alameda, California. We anticipate entering into additional contractual agreements related to the construction and furnishing of those facilities in 2018. At December 31, 2017, we also had firm purchase commitments related to manufacturing and maintenance of inventory.
|
|
Page
|
|
December 31,
|
||||||
|
2017
|
|
2016
|
||||
ASSETS
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
183,164
|
|
|
$
|
151,686
|
|
Short-term investments
|
204,607
|
|
|
268,117
|
|
||
Short-term restricted cash and investments
|
504
|
|
|
—
|
|
||
Trade and other receivables, net
|
81,192
|
|
|
40,444
|
|
||
Inventory, net
|
6,657
|
|
|
3,338
|
|
||
Prepaid expenses and other current assets
|
8,750
|
|
|
5,416
|
|
||
Total current assets
|
484,874
|
|
|
469,001
|
|
||
Long-term investments
|
64,255
|
|
|
55,601
|
|
||
Long-term restricted cash and investments
|
4,646
|
|
|
4,150
|
|
||
Property and equipment, net
|
25,743
|
|
|
2,071
|
|
||
Goodwill
|
63,684
|
|
|
63,684
|
|
||
Other long-term assets
|
12,092
|
|
|
1,232
|
|
||
Total assets
|
$
|
655,294
|
|
|
$
|
595,739
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
|
|
|
||||
Current liabilities:
|
|
|
|
||||
Accounts payable
|
$
|
9,575
|
|
|
$
|
6,565
|
|
Accrued compensation and benefits
|
21,073
|
|
|
20,334
|
|
||
Accrued clinical trial liabilities
|
19,849
|
|
|
14,131
|
|
||
Accrued collaboration liabilities
|
8,974
|
|
|
2,046
|
|
||
Rebates and fees due to customers
|
7,565
|
|
|
3,420
|
|
||
Current portion of deferred revenue
|
31,984
|
|
|
19,665
|
|
||
Convertible notes
|
—
|
|
|
109,122
|
|
||
Term loan payable
|
—
|
|
|
80,000
|
|
||
Other current liabilities
|
16,150
|
|
|
13,503
|
|
||
Total current liabilities
|
115,170
|
|
|
268,786
|
|
||
Long-term portion of deferred revenue
|
238,520
|
|
|
237,094
|
|
||
Other long-term liabilities
|
16,643
|
|
|
541
|
|
||
Total liabilities
|
370,333
|
|
|
506,421
|
|
||
Commitments (Note 12)
|
|
|
|
||||
Stockholders’ equity:
|
|
|
|
||||
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: 296,209,426 and 289,923,798 at December 31, 2017 and 2016, respectively
|
296
|
|
|
290
|
|
||
Additional paid-in capital
|
2,114,184
|
|
|
2,072,591
|
|
||
Accumulated other comprehensive loss
|
(347
|
)
|
|
(416
|
)
|
||
Accumulated deficit
|
(1,829,172
|
)
|
|
(1,983,147
|
)
|
||
Total stockholders’ equity
|
284,961
|
|
|
89,318
|
|
||
Total liabilities and stockholders’ equity
|
$
|
655,294
|
|
|
$
|
595,739
|
|
|
Year Ended December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
Revenues:
|
|
|
|
|
|
||||||
Net product revenues
|
$
|
349,008
|
|
|
$
|
135,375
|
|
|
$
|
34,158
|
|
Collaboration revenues
|
103,469
|
|
|
56,079
|
|
|
3,014
|
|
|||
Total revenues
|
452,477
|
|
|
191,454
|
|
|
37,172
|
|
|||
Operating expenses:
|
|
|
|
|
|
||||||
Cost of goods sold
|
15,066
|
|
|
6,552
|
|
|
3,895
|
|
|||
Research and development
|
112,171
|
|
|
95,967
|
|
|
96,351
|
|
|||
Selling, general and administrative
|
159,362
|
|
|
116,145
|
|
|
57,305
|
|
|||
Restructuring (recovery) charge
|
(32
|
)
|
|
914
|
|
|
1,042
|
|
|||
Total operating expenses
|
286,567
|
|
|
219,578
|
|
|
158,593
|
|
|||
Income (loss) from operations
|
165,910
|
|
|
(28,124
|
)
|
|
(121,421
|
)
|
|||
Other expenses, net:
|
|
|
|
|
|
||||||
Interest income
|
4,883
|
|
|
2,578
|
|
|
793
|
|
|||
Interest expense
|
(8,679
|
)
|
|
(33,060
|
)
|
|
(40,680
|
)
|
|||
Other, net
|
(3,537
|
)
|
|
(11,616
|
)
|
|
(381
|
)
|
|||
Total other expenses, net
|
(7,333
|
)
|
|
(42,098
|
)
|
|
(40,268
|
)
|
|||
Income (loss) before income taxes
|
158,577
|
|
|
(70,222
|
)
|
|
(161,689
|
)
|
|||
Provision for income taxes
|
4,350
|
|
|
—
|
|
|
55
|
|
|||
Net income (loss)
|
$
|
154,227
|
|
|
$
|
(70,222
|
)
|
|
$
|
(161,744
|
)
|
Net income (loss) per share, basic
|
$
|
0.52
|
|
|
$
|
(0.28
|
)
|
|
$
|
(0.77
|
)
|
Net income (loss) per share, diluted
|
$
|
0.49
|
|
|
$
|
(0.28
|
)
|
|
$
|
(0.77
|
)
|
Shares used in computing net income (loss) per share, basic
|
293,588
|
|
|
250,531
|
|
|
209,227
|
|
|||
Shares used in computing net income (loss) per share, diluted
|
312,003
|
|
|
250,531
|
|
|
209,227
|
|
|
Year Ended December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
Net income (loss)
|
$
|
154,227
|
|
|
$
|
(70,222
|
)
|
|
$
|
(161,744
|
)
|
Other comprehensive income (loss)
(1)
|
69
|
|
|
(184
|
)
|
|
(111
|
)
|
|||
Comprehensive income (loss)
|
$
|
154,296
|
|
|
$
|
(70,406
|
)
|
|
$
|
(161,855
|
)
|
(1)
|
Other comprehensive income (loss) consisted solely of unrealized gains or losses, net, on available-for-sale securities arising during the periods presented. There were nominal or
no
reclassification adjustments to net income (loss) resulting from realized gains or losses on the sale of securities and there was
no
income tax expense related to other comprehensive income (loss) during the periods presented.
|
|
Common Stock
|
|
Additional
Paid-in Capital |
|
Accumulated
Other Comprehensive Loss |
|
Accumulated
Deficit |
|
Total
Stockholders’ Equity (Deficit) |
|||||||||||||
|
Shares
|
|
Amount
|
|
|
|
|
|||||||||||||||
Balance at December 31, 2014
|
195,895,769
|
|
|
$
|
196
|
|
|
$
|
1,591,782
|
|
|
$
|
(121
|
)
|
|
$
|
(1,751,181
|
)
|
|
$
|
(159,324
|
)
|
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(161,744
|
)
|
|
(161,744
|
)
|
|||||
Other comprehensive loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(111
|
)
|
|
—
|
|
|
(111
|
)
|
|||||
Sale of shares of common stock, net
|
28,750,000
|
|
|
29
|
|
|
145,620
|
|
|
—
|
|
|
—
|
|
|
145,649
|
|
|||||
Issuance of common stock under equity incentive and stock purchase plans
|
3,315,174
|
|
|
3
|
|
|
11,274
|
|
|
—
|
|
|
—
|
|
|
11,277
|
|
|||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
21,977
|
|
|
—
|
|
|
—
|
|
|
21,977
|
|
|||||
Warrants transferred from other long-term liabilities
|
—
|
|
|
—
|
|
|
1,470
|
|
|
—
|
|
|
—
|
|
|
1,470
|
|
|||||
Balance at December 31, 2015
|
227,960,943
|
|
|
228
|
|
|
1,772,123
|
|
|
(232
|
)
|
|
(1,912,925
|
)
|
|
(140,806
|
)
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(70,222
|
)
|
|
(70,222
|
)
|
|||||
Other comprehensive loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(184
|
)
|
|
—
|
|
|
(184
|
)
|
|||||
Issuance of common stock in settlement of convertible notes
|
54,009,279
|
|
|
54
|
|
|
253,026
|
|
|
—
|
|
|
—
|
|
|
253,080
|
|
|||||
Issuance of common stock under equity incentive and stock purchase plans
|
7,953,576
|
|
|
8
|
|
|
24,530
|
|
|
—
|
|
|
—
|
|
|
24,538
|
|
|||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
22,912
|
|
|
—
|
|
|
—
|
|
|
22,912
|
|
|||||
Balance at December 31, 2016
|
289,923,798
|
|
|
290
|
|
|
2,072,591
|
|
|
(416
|
)
|
|
(1,983,147
|
)
|
|
89,318
|
|
|||||
Adoption of Accounting Standards Update No. 2016-09
|
—
|
|
|
—
|
|
|
252
|
|
|
—
|
|
|
(252
|
)
|
|
—
|
|
|||||
Net income
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
154,227
|
|
|
154,227
|
|
|||||
Other comprehensive income
|
—
|
|
|
—
|
|
|
—
|
|
|
69
|
|
|
—
|
|
|
69
|
|
|||||
Issuance of common stock under equity incentive and stock purchase plans
|
5,408,177
|
|
|
5
|
|
|
17,404
|
|
|
—
|
|
|
—
|
|
|
17,409
|
|
|||||
Issuance of common stock on warrant exercise
|
877,451
|
|
|
1
|
|
|
(1
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
23,938
|
|
|
—
|
|
|
—
|
|
|
23,938
|
|
|||||
Balance at December 31, 2017
|
296,209,426
|
|
|
$
|
296
|
|
|
$
|
2,114,184
|
|
|
$
|
(347
|
)
|
|
$
|
(1,829,172
|
)
|
|
$
|
284,961
|
|
|
Year Ended December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
Net income (loss)
|
$
|
154,227
|
|
|
$
|
(70,222
|
)
|
|
$
|
(161,744
|
)
|
Adjustments to reconcile net income (loss) to net cash provided by operating activities:
|
|
|
|
|
|
||||||
Depreciation and amortization
|
1,187
|
|
|
1,002
|
|
|
1,406
|
|
|||
Stock-based compensation
|
23,938
|
|
|
22,912
|
|
|
21,977
|
|
|||
Loss on extinguishment of debt
|
6,239
|
|
|
13,901
|
|
|
—
|
|
|||
Amortization of debt discounts and debt issuance costs
|
182
|
|
|
8,432
|
|
|
17,041
|
|
|||
Interest paid in kind
|
(11,825
|
)
|
|
8,008
|
|
|
3,817
|
|
|||
Gain on other equity investments
|
(2,980
|
)
|
|
(2,494
|
)
|
|
(112
|
)
|
|||
Changes in warrant fair value
|
—
|
|
|
—
|
|
|
548
|
|
|||
Other
|
1,589
|
|
|
1,598
|
|
|
1,861
|
|
|||
Changes in assets and liabilities:
|
|
|
|
|
|
||||||
Trade and other receivables
|
(40,839
|
)
|
|
(35,318
|
)
|
|
(540
|
)
|
|||
Inventory, net
|
(3,319
|
)
|
|
(722
|
)
|
|
(235
|
)
|
|||
Prepaid expenses and other current assets
|
(3,268
|
)
|
|
(1,610
|
)
|
|
(325
|
)
|
|||
Other long-term assets
|
430
|
|
|
1,077
|
|
|
1,340
|
|
|||
Accounts payable
|
3,010
|
|
|
164
|
|
|
(12
|
)
|
|||
Accrued compensation and benefits
|
739
|
|
|
16,705
|
|
|
279
|
|
|||
Accrued clinical trial liabilities
|
5,718
|
|
|
(3,940
|
)
|
|
(23,474
|
)
|
|||
Accrued collaboration liabilities
|
6,928
|
|
|
(10,938
|
)
|
|
10,206
|
|
|||
Deferred revenue
|
13,745
|
|
|
256,759
|
|
|
(2,582
|
)
|
|||
Other current and long-term liabilities
|
9,910
|
|
|
5,090
|
|
|
(10,502
|
)
|
|||
Net cash provided by (used in) operating activities
|
165,611
|
|
|
210,404
|
|
|
(141,051
|
)
|
|||
Cash flows from investing activities:
|
|
|
|
|
|
||||||
Purchases of property and equipment
|
(21,143
|
)
|
|
(1,703
|
)
|
|
(447
|
)
|
|||
Proceeds from sale of property and equipment
|
164
|
|
|
97
|
|
|
1,346
|
|
|||
Purchases of investments
|
(319,090
|
)
|
|
(369,187
|
)
|
|
(143,992
|
)
|
|||
Proceeds from maturities of investments
|
336,590
|
|
|
151,485
|
|
|
178,936
|
|
|||
Proceeds from sale of investments
|
37,294
|
|
|
2,266
|
|
|
—
|
|
|||
Purchase of restricted cash and investments
|
(15,650
|
)
|
|
(8,650
|
)
|
|
(5,650
|
)
|
|||
Proceeds from maturities of restricted cash and investments
|
14,650
|
|
|
7,150
|
|
|
19,789
|
|
|||
Proceeds from other equity investments
|
2,980
|
|
|
2,494
|
|
|
95
|
|
|||
Net cash provided by (used in) investing activities
|
35,795
|
|
|
(216,048
|
)
|
|
50,077
|
|
|||
Cash flows from financing activities:
|
|
|
|
|
|
||||||
Principal repayments of debt
|
(185,788
|
)
|
|
(575
|
)
|
|
(4,381
|
)
|
|||
Payments on conversion of convertible notes
|
—
|
|
|
(7,135
|
)
|
|
—
|
|
|||
Proceeds from issuance of common stock, net
|
—
|
|
|
—
|
|
|
145,649
|
|
|||
Proceeds from exercise of stock options
|
17,555
|
|
|
25,327
|
|
|
10,911
|
|
|||
Proceeds from employee stock purchase plan
|
4,868
|
|
|
2,187
|
|
|
568
|
|
|||
Taxes paid related to net share settlement of equity awards
|
(6,563
|
)
|
|
(4,108
|
)
|
|
(534
|
)
|
|||
Net cash (used in) provided by financing activities
|
(169,928
|
)
|
|
15,696
|
|
|
152,213
|
|
|||
Net increase in cash and cash equivalents
|
31,478
|
|
|
10,052
|
|
|
61,239
|
|
|||
Cash and cash equivalents at beginning of year
|
151,686
|
|
|
141,634
|
|
|
80,395
|
|
|||
Cash and cash equivalents at end of year
|
$
|
183,164
|
|
|
$
|
151,686
|
|
|
$
|
141,634
|
|
|
Year Ended December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
Supplemental cash flow disclosure:
|
|
|
|
|
|
||||||
Cash paid for interest
|
$
|
20,460
|
|
|
$
|
21,044
|
|
|
$
|
19,822
|
|
Cash paid for taxes
|
$
|
538
|
|
|
$
|
190
|
|
|
$
|
192
|
|
Non-cash investing and financing activity:
|
|
|
|
|
|
||||||
Construction in progress deemed to have been acquired under build-to-suit lease
|
$
|
14,530
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Issuance of common stock in settlement of convertible notes
|
$
|
—
|
|
|
$
|
286,925
|
|
|
$
|
—
|
|
Asset Category
|
|
Estimated Useful Life
|
Buildings
|
|
40 years
|
Lab equipment
|
|
5 years
|
Furniture and fixtures
|
|
5 years
|
Computer equipment and software
|
|
3 years
|
Leasehold improvements
|
|
7 to 15 years
|
|
Chargebacks and discounts for prompt payment
|
|
Other customer credits/fees and co-pay assistance
|
|
Rebates
|
|
Returns
|
|
Total
|
||||||||||
Balance at December 31, 2015
|
$
|
119
|
|
|
$
|
251
|
|
|
$
|
891
|
|
|
$
|
38
|
|
|
$
|
1,299
|
|
Provision related to sales made in:
|
|
|
|
|
|
|
|
|
—
|
|
|||||||||
Current period
|
8,271
|
|
|
2,747
|
|
|
5,105
|
|
|
359
|
|
|
16,482
|
|
|||||
Prior periods
|
(39
|
)
|
|
2
|
|
|
(313
|
)
|
|
(8
|
)
|
|
(358
|
)
|
|||||
Payments and customer credits issued
|
(6,549
|
)
|
|
(2,206
|
)
|
|
(3,056
|
)
|
|
(38
|
)
|
|
(11,849
|
)
|
|||||
Balance at December 31, 2016
|
1,802
|
|
|
794
|
|
|
2,627
|
|
|
351
|
|
|
5,574
|
|
|||||
Provision related to sales made in:
|
|
|
|
|
|
|
|
|
|
||||||||||
Current period
|
33,310
|
|
|
7,301
|
|
|
14,390
|
|
|
—
|
|
|
55,001
|
|
|||||
Prior periods
|
(817
|
)
|
|
—
|
|
|
(624
|
)
|
|
—
|
|
|
(1,441
|
)
|
|||||
Payments and customer credits issued
|
(32,367
|
)
|
|
(6,300
|
)
|
|
(10,623
|
)
|
|
(351
|
)
|
|
(49,641
|
)
|
|||||
Balance at December 31, 2017
|
$
|
1,928
|
|
|
$
|
1,795
|
|
|
$
|
5,770
|
|
|
$
|
—
|
|
|
$
|
9,493
|
|
|
Year Ended December 31,
|
||||||
|
2017
|
|
2016
|
||||
Milestones achieved
|
$
|
45,000
|
|
|
$
|
20,000
|
|
Amortization of upfront payments and deferred milestone
|
18,531
|
|
|
13,284
|
|
||
Royalty revenue
|
3,831
|
|
|
175
|
|
||
Development cost reimbursements
|
4,417
|
|
|
—
|
|
||
Product supply agreement revenue
|
6,390
|
|
|
1,612
|
|
||
Cost of supplied product
|
(6,390
|
)
|
|
(1,555
|
)
|
||
Royalty payable to GSK on net sales by Ipsen
|
(1,987
|
)
|
|
(264
|
)
|
||
Collaboration revenues under the collaboration agreement with Ipsen
|
$
|
69,792
|
|
|
$
|
33,252
|
|
|
Year Ended December 31, 2017
|
||
Amortization of upfront payment
|
$
|
10,377
|
|
Development cost reimbursements
|
4,320
|
|
|
Product supply agreement revenue
|
82
|
|
|
Collaboration revenues under the collaboration agreement with Takeda
|
$
|
14,779
|
|
|
Year Ended December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
Collaboration revenues:
|
|
|
|
|
|
||||||
Royalty revenues on ex-U.S. sales of COTELLIC
|
$
|
6,398
|
|
|
$
|
2,827
|
|
|
$
|
14
|
|
U.S. (loss) net cost recovery under the collaboration agreement included in Selling, general and administrative expenses
|
$
|
(2,140
|
)
|
|
$
|
8,771
|
|
|
$
|
(16,600
|
)
|
|
Year Ended December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
Royalties accruing to GSK
|
$
|
12,413
|
|
|
$
|
4,334
|
|
|
$
|
1,029
|
|
|
December 31, 2017
|
||||||||||||||
|
Amortized
Cost
|
|
Gross
Unrealized
Gains
|
|
Gross
Unrealized
Losses
|
|
Fair Value
|
||||||||
Money market funds
|
$
|
45,478
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
45,478
|
|
Commercial paper
|
199,647
|
|
|
—
|
|
|
—
|
|
|
199,647
|
|
||||
Corporate bonds
|
179,336
|
|
|
18
|
|
|
(332
|
)
|
|
179,022
|
|
||||
U.S. Treasury and government sponsored enterprises
|
16,295
|
|
|
—
|
|
|
(32
|
)
|
|
16,263
|
|
||||
Total
|
$
|
440,756
|
|
|
$
|
18
|
|
|
$
|
(364
|
)
|
|
$
|
440,410
|
|
|
December 31, 2016
|
||||||||||||||
|
Amortized
Cost
|
|
Gross
Unrealized
Gains
|
|
Gross
Unrealized
Losses
|
|
Fair Value
|
||||||||
Money market funds
|
$
|
71,457
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
71,457
|
|
Commercial paper
|
165,375
|
|
|
—
|
|
|
—
|
|
|
165,375
|
|
||||
Corporate bonds
|
152,712
|
|
|
3
|
|
|
(308
|
)
|
|
152,407
|
|
||||
U.S. Treasury and government sponsored enterprises
|
70,730
|
|
|
11
|
|
|
(14
|
)
|
|
70,727
|
|
||||
Total
|
$
|
460,274
|
|
|
$
|
14
|
|
|
$
|
(322
|
)
|
|
$
|
459,966
|
|
|
December 31, 2017
|
||||||||||||||||||||||
|
In an Unrealized Loss Position Less than 12 Months
|
|
In an Unrealized Loss Position 12 Months or Greater
|
|
Total
|
||||||||||||||||||
|
Fair Value
|
|
Gross
Unrealized Losses |
|
Fair Value
|
|
Gross
Unrealized Losses |
|
Fair Value
|
|
Gross
Unrealized Losses |
||||||||||||
Corporate bonds
|
$
|
140,746
|
|
|
$
|
(296
|
)
|
|
$
|
20,047
|
|
|
$
|
(36
|
)
|
|
$
|
160,793
|
|
|
$
|
(332
|
)
|
U.S. Treasury and government sponsored enterprises
|
13,611
|
|
|
(23
|
)
|
|
2,651
|
|
|
(9
|
)
|
|
16,262
|
|
|
(32
|
)
|
||||||
Total
|
$
|
154,357
|
|
|
$
|
(319
|
)
|
|
$
|
22,698
|
|
|
$
|
(45
|
)
|
|
$
|
177,055
|
|
|
$
|
(364
|
)
|
|
December 31, 2016
|
||||||||||||||||||||||
|
In an Unrealized Loss Position Less than 12 Months
|
|
In an Unrealized Loss Position 12 Months or Greater
|
|
Total
|
||||||||||||||||||
|
Fair Value
|
|
Gross
Unrealized Losses |
|
Fair Value
|
|
Gross
Unrealized Losses |
|
Fair Value
|
|
Gross
Unrealized Losses |
||||||||||||
Corporate bonds
|
$
|
140,559
|
|
|
$
|
(305
|
)
|
|
$
|
3,001
|
|
|
$
|
(3
|
)
|
|
$
|
143,560
|
|
|
$
|
(308
|
)
|
U.S. Treasury and government sponsored enterprises
|
27,657
|
|
|
(14
|
)
|
|
—
|
|
|
—
|
|
|
27,657
|
|
|
(14
|
)
|
||||||
Commercial paper
(1)
|
998
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
998
|
|
|
—
|
|
||||||
Total
|
$
|
169,214
|
|
|
$
|
(319
|
)
|
|
$
|
3,001
|
|
|
$
|
(3
|
)
|
|
$
|
172,215
|
|
|
$
|
(322
|
)
|
(1)
|
Gross unrealized losses on commercial paper were less than
$1
thousand.
|
|
December 31,
|
||||||
|
2017
|
|
2016
|
||||
Maturing in one year or less
|
$
|
377,155
|
|
|
$
|
404,365
|
|
Maturing after one year through five years
|
63,255
|
|
|
55,601
|
|
||
Total
|
$
|
440,410
|
|
|
$
|
459,966
|
|
|
December 31,
|
||||||
|
2017
|
|
2016
|
||||
Raw materials
|
$
|
498
|
|
|
$
|
863
|
|
Work in process
|
3,997
|
|
|
2,343
|
|
||
Finished goods
|
2,854
|
|
|
738
|
|
||
Total
|
$
|
7,349
|
|
|
$
|
3,944
|
|
|
|
|
|
||||
Balance Sheet classification:
|
|
|
|
||||
Inventory
|
$
|
6,657
|
|
|
$
|
3,338
|
|
Other long-term assets
|
692
|
|
|
606
|
|
||
Total
|
$
|
7,349
|
|
|
$
|
3,944
|
|
|
December 31,
2017 |
|
December 31,
2016 |
||||
Computer equipment and software
|
$
|
14,146
|
|
|
$
|
13,738
|
|
Laboratory equipment
|
5,959
|
|
|
4,310
|
|
||
Leasehold improvements
|
4,715
|
|
|
6,646
|
|
||
Furniture and fixtures
|
1,609
|
|
|
2,240
|
|
||
Construction in progress
|
22,114
|
|
|
19
|
|
||
|
48,543
|
|
|
26,953
|
|
||
Less: accumulated depreciation and amortization
|
(22,800
|
)
|
|
(24,882
|
)
|
||
Property and equipment, net
|
$
|
25,743
|
|
|
$
|
2,071
|
|
|
December 31,
|
||||||
|
2017
|
|
2016
|
||||
Convertible notes
|
$
|
—
|
|
|
$
|
109,122
|
|
Term loan payable
|
—
|
|
|
80,000
|
|
||
Total debt
|
$
|
—
|
|
|
$
|
189,122
|
|
|
Year Ended December 31, 2016
|
||
Cash inducements
|
$
|
2,394
|
|
Waiver of requirement to repay interest, described above
|
3,572
|
|
|
Difference between the total settlement consideration attributed to the liability component of the 2019 Notes and the net carrying value of the liability
|
7,338
|
|
|
Unamortized discount on redeemed notes
|
83
|
|
|
Third-party costs
|
514
|
|
|
Loss on extinguishment of debt
|
$
|
13,901
|
|
|
Year Ended December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
Research and development
|
$
|
7,569
|
|
|
$
|
9,366
|
|
|
$
|
11,691
|
|
Selling, general and administrative
|
16,369
|
|
|
13,546
|
|
|
10,286
|
|
|||
Total stock-based compensation
|
$
|
23,938
|
|
|
$
|
22,912
|
|
|
$
|
21,977
|
|
|
Year Ended December 31,
|
|||||||
|
2017
|
|
2016
|
|
2015
|
|||
Stock options:
|
|
|
|
|
|
|||
Risk-free interest rate
|
1.98
|
%
|
|
1.15
|
%
|
|
1.22
|
%
|
Dividend yield
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
Volatility
|
59
|
%
|
|
76
|
%
|
|
93
|
%
|
Expected life
|
4.5 years
|
|
|
4.4 years
|
|
|
4.5 years
|
|
ESPP:
|
|
|
|
|
|
|||
Risk-free interest rate
|
1.09
|
%
|
|
0.55
|
%
|
|
0.15
|
%
|
Dividend yield
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
Volatility
|
58
|
%
|
|
65
|
%
|
|
98
|
%
|
Expected life
|
6 months
|
|
|
6 months
|
|
|
6 months
|
|
|
Year Ended December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
Domestic
|
$
|
158,577
|
|
|
$
|
(70,222
|
)
|
|
$
|
(150,846
|
)
|
Foreign
|
—
|
|
|
—
|
|
|
(10,843
|
)
|
|||
Income (loss) before income taxes
|
$
|
158,577
|
|
|
$
|
(70,222
|
)
|
|
$
|
(161,689
|
)
|
|
Year Ended December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
Current:
|
|
|
|
|
|
||||||
Federal
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
State
|
4,350
|
|
|
—
|
|
|
55
|
|
|||
Total current tax expense
|
4,350
|
|
|
—
|
|
|
55
|
|
|||
Deferred:
|
|
|
|
|
|
||||||
Federal
|
—
|
|
|
—
|
|
|
—
|
|
|||
State
|
—
|
|
|
—
|
|
|
—
|
|
|||
Total deferred tax expense
|
—
|
|
|
—
|
|
|
—
|
|
|||
Provision for income taxes
|
$
|
4,350
|
|
|
$
|
—
|
|
|
$
|
55
|
|
|
Year Ended December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
U.S. federal income tax provision (benefit) at statutory rate
|
$
|
53,916
|
|
|
$
|
(23,876
|
)
|
|
$
|
(54,974
|
)
|
Change in valuation allowance
|
(34,266
|
)
|
|
6,377
|
|
|
51,421
|
|
|||
State tax expense
|
8,282
|
|
|
6,520
|
|
|
55
|
|
|||
Debt extinguishment
|
—
|
|
|
4,726
|
|
|
—
|
|
|||
Non-deductible interest
|
1,367
|
|
|
2,680
|
|
|
3,308
|
|
|||
Stock-based compensation
|
(20,548
|
)
|
|
3,155
|
|
|
195
|
|
|||
Other
|
(4,401
|
)
|
|
418
|
|
|
50
|
|
|||
Provision for income taxes
|
$
|
4,350
|
|
|
$
|
—
|
|
|
$
|
55
|
|
|
December 31,
|
||||||
|
2017
|
|
2016
|
||||
Deferred tax assets:
|
|
|
|
||||
Net operating loss carry-forwards
|
$
|
244,205
|
|
|
$
|
471,327
|
|
Book over tax depreciation and amortization
|
39,472
|
|
|
70,617
|
|
||
Tax credit and charitable contribution carry-forwards
|
66,770
|
|
|
64,367
|
|
||
Deferred revenue
|
53,543
|
|
|
—
|
|
||
Amortization of deferred stock compensation – non-qualified
|
8,966
|
|
|
14,780
|
|
||
Accruals and reserves not currently deductible
|
4,914
|
|
|
8,117
|
|
||
Other assets
|
1,088
|
|
|
106
|
|
||
Total deferred tax assets
|
418,958
|
|
|
629,314
|
|
||
Valuation allowance
|
(418,958
|
)
|
|
(629,062
|
)
|
||
Net deferred tax assets
|
—
|
|
|
252
|
|
||
Deferred tax liabilities:
|
|
|
|
||||
Unrealized gains on derivatives and other liabilities
|
—
|
|
|
(252
|
)
|
||
Total deferred tax liabilities
|
—
|
|
|
(252
|
)
|
||
Net deferred taxes
|
$
|
—
|
|
|
$
|
—
|
|
|
Year Ended December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
Beginning balance
|
$
|
61,809
|
|
|
$
|
88,638
|
|
|
$
|
58,215
|
|
Change relating to prior year provision
|
247
|
|
|
(29,110
|
)
|
|
21,696
|
|
|||
Change relating to current year provision
|
17,378
|
|
|
2,304
|
|
|
8,727
|
|
|||
Reductions based on the lapse of the applicable statutes of limitations
|
(92
|
)
|
|
(23
|
)
|
|
—
|
|
|||
Ending balance
|
$
|
79,342
|
|
|
$
|
61,809
|
|
|
$
|
88,638
|
|
|
Year Ended December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
Numerator:
|
|
|
|
|
|
||||||
Net income (loss)
|
$
|
154,227
|
|
|
$
|
(70,222
|
)
|
|
$
|
(161,744
|
)
|
Net income allocated to participating securities
|
(367
|
)
|
|
—
|
|
|
—
|
|
|||
Net income allocable to common stock for basic net income (loss) per share
|
153,860
|
|
|
(70,222
|
)
|
|
(161,744
|
)
|
|||
Adjustment to net income allocated to participating securities
|
22
|
|
|
—
|
|
|
—
|
|
|||
Net income allocable to common stock for diluted net income (loss) per share
|
$
|
153,882
|
|
|
$
|
(70,222
|
)
|
|
$
|
(161,744
|
)
|
Denominator:
|
|
|
|
|
|
||||||
Weighted-average shares of common stock outstanding used in computing basic net income (loss) per share
|
293,588
|
|
|
250,531
|
|
|
209,227
|
|
|||
Dilutive securities:
|
|
|
|
|
|
||||||
Outstanding stock options, unvested RSUs and ESPP contributions
|
18,415
|
|
|
—
|
|
|
—
|
|
|||
Weighted-average shares of common stock outstanding and dilutive securities used in computing diluted net income (loss) per share
|
312,003
|
|
|
250,531
|
|
|
209,227
|
|
|||
|
|
|
|
|
|
||||||
Net income (loss) per share, basic
|
$
|
0.52
|
|
|
$
|
(0.28
|
)
|
|
$
|
(0.77
|
)
|
Net income (loss) per share, diluted
|
$
|
0.49
|
|
|
$
|
(0.28
|
)
|
|
$
|
(0.77
|
)
|
|
Year Ended December 31,
|
|||||||
|
2017
|
|
2016
|
|
2015
|
|||
Outstanding stock options, unvested RSUs and ESPP contributions
|
1,645
|
|
|
27,568
|
|
|
28,470
|
|
Deerfield Notes
|
—
|
|
|
33,890
|
|
|
33,890
|
|
2014 Warrants
|
—
|
|
|
1,000
|
|
|
1,000
|
|
2019 Notes
|
—
|
|
|
—
|
|
|
54,118
|
|
Total potentially dilutive shares
|
1,645
|
|
|
62,458
|
|
|
117,478
|
|
|
December 31, 2017
|
||||||||||
|
Level 1
|
|
Level 2
|
|
Total
|
||||||
Money market funds
|
$
|
45,478
|
|
|
$
|
—
|
|
|
$
|
45,478
|
|
Commercial paper
|
—
|
|
|
199,647
|
|
|
199,647
|
|
|||
Corporate bonds
|
—
|
|
|
179,022
|
|
|
179,022
|
|
|||
U.S. Treasury and government sponsored enterprises
|
—
|
|
|
16,263
|
|
|
16,263
|
|
|||
Total financial assets
|
$
|
45,478
|
|
|
$
|
394,932
|
|
|
$
|
440,410
|
|
|
December 31, 2016
|
||||||||||
|
Level 1
|
|
Level 2
|
|
Total
|
||||||
Money market funds
|
$
|
71,457
|
|
|
$
|
—
|
|
|
$
|
71,457
|
|
Commercial paper
|
—
|
|
|
165,375
|
|
|
165,375
|
|
|||
Corporate bonds
|
—
|
|
|
152,407
|
|
|
152,407
|
|
|||
U.S. Treasury and government sponsored enterprises
|
—
|
|
|
70,727
|
|
|
70,727
|
|
|||
Total financial assets
|
$
|
71,457
|
|
|
$
|
388,509
|
|
|
$
|
459,966
|
|
•
|
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 for similar assets as observable inputs for pricing, which is a Level 2 input.
|
•
|
We estimated the fair value of our debt instruments using the net present value of estimated future cash flows through maturity. For the Deerfield Notes, we used a discount rate of
9.5%
, which we estimated as our current borrowing rate for similar debt as of December 31, 2016, which is a Level 3 input.
For the term loan payable, we used 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.
|
•
|
The settlement consideration comprises, in part, shares of our Common Stock. The fair value of our Common Stock was determined based on the closing market price of our Common Stock on the various settlement dates of the conversions, which are level 1 inputs;
|
•
|
The carrying value of the remaining settlement consideration, which includes cash and the forgiveness of the repayment of certain prior interest payments, approximates fair value;
|
•
|
We estimated the fair value of the liability component of the 2019 Notes using the net present value of estimated future cash flows through maturity. We used a discount rate of
9.5%
, which we estimated as our current borrowing rate for straight debt as of September 30, 2016, which is a Level 3 input.
|
|
|
Operating leases
|
|
Other financing obligations
(1)
|
||||
Year ending December 31,
|
|
|
|
|
||||
2018
|
|
$
|
2,864
|
|
|
$
|
800
|
|
2019
|
|
664
|
|
|
1,905
|
|
||
2020
|
|
684
|
|
|
2,129
|
|
||
2021
|
|
694
|
|
|
2,213
|
|
||
2022
|
|
704
|
|
|
2,282
|
|
||
Thereafter
|
|
3,730
|
|
|
12,164
|
|
||
|
|
$
|
9,340
|
|
|
$
|
21,493
|
|
(1)
|
Other financing obligations includes payments related to our build-to-suit lease.
|
|
Year Ended December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
Gross rental expense
|
$
|
6,160
|
|
|
$
|
9,676
|
|
|
$
|
13,942
|
|
less: Sublease income
|
(1,225
|
)
|
|
(3,553
|
)
|
|
(5,205
|
)
|
|||
Net rental expense
|
$
|
4,935
|
|
|
$
|
6,123
|
|
|
$
|
8,737
|
|
|
Year Ended December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
CABOMETYX
|
$
|
324,000
|
|
|
$
|
93,481
|
|
|
$
|
—
|
|
COMETRIQ
|
25,008
|
|
|
41,894
|
|
|
34,158
|
|
|||
Net product revenues
|
$
|
349,008
|
|
|
$
|
135,375
|
|
|
$
|
34,158
|
|
|
Year Ended December 31,
|
|||||||
|
2017
|
|
2016
|
|
2015
|
|||
Diplomat Specialty Pharmacy
|
18
|
%
|
|
33
|
%
|
|
83
|
%
|
Caremark L.L.C.
|
16
|
%
|
|
9
|
%
|
|
—
|
%
|
Ipsen
|
15
|
%
|
|
17
|
%
|
|
—
|
%
|
Accredo Health, Incorporated
|
11
|
%
|
|
9
|
%
|
|
—
|
%
|
Affiliates of McKesson Corporation
|
11
|
%
|
|
7
|
%
|
|
—
|
%
|
|
Quarter Ended
|
||||||||||||||
|
December 31,
|
|
September 30,
|
|
June 30,
|
|
March 31,
|
||||||||
2017:
|
|
|
|
|
|
|
|
||||||||
Total revenues
|
$
|
120,072
|
|
|
$
|
152,510
|
|
|
$
|
99,008
|
|
|
$
|
80,887
|
|
Gross profit
(1)
|
$
|
91,520
|
|
|
$
|
91,758
|
|
|
$
|
84,990
|
|
|
$
|
65,674
|
|
Income from operations
|
$
|
37,431
|
|
|
$
|
81,180
|
|
|
$
|
27,113
|
|
|
$
|
20,186
|
|
Net income
|
$
|
38,489
|
|
|
$
|
81,382
|
|
|
$
|
17,656
|
|
|
$
|
16,700
|
|
Net income per share, basic
|
$
|
0.13
|
|
|
$
|
0.28
|
|
|
$
|
0.06
|
|
|
$
|
0.06
|
|
Net income per share, diluted
|
$
|
0.12
|
|
|
$
|
0.26
|
|
|
$
|
0.06
|
|
|
$
|
0.05
|
|
2016:
|
|
|
|
|
|
|
|
||||||||
Total revenues
|
$
|
77,581
|
|
|
$
|
62,194
|
|
|
$
|
36,252
|
|
|
$
|
15,427
|
|
Gross profit
(1)
|
$
|
50,064
|
|
|
$
|
40,287
|
|
|
$
|
30,058
|
|
|
$
|
8,414
|
|
Income (loss) from operations
|
$
|
38,883
|
|
|
$
|
7,264
|
|
|
$
|
(25,136
|
)
|
|
$
|
(49,135
|
)
|
Net income (loss)
|
$
|
35,123
|
|
|
$
|
(11,284
|
)
|
|
$
|
(34,838
|
)
|
|
$
|
(59,223
|
)
|
Net income (loss) per share, basic
|
$
|
0.12
|
|
|
$
|
(0.04
|
)
|
|
$
|
(0.15
|
)
|
|
$
|
(0.26
|
)
|
Net income (loss) per share, diluted
|
$
|
0.12
|
|
|
$
|
(0.04
|
)
|
|
$
|
(0.15
|
)
|
|
$
|
(0.26
|
)
|
(1)
|
Gross profit is computed as Net product revenues less Cost of goods sold.
|
ITEM 10.
|
DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
|
Plan Category
|
|
Number of
securities to be issued upon exercise of outstanding
options, warrants and rights
|
|
Weighted-average exercise price of outstanding
options, warrants and
rights
|
|
Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a))
|
||||
|
|
(a)
|
|
(b)
|
|
(c)
|
||||
Equity compensation plans approved by stockholders
(1)
|
|
25,576,186
|
|
|
$
|
5.73
|
|
(2)
|
25,381,045
|
|
Equity compensation plans not approved by stockholders
(3)
|
|
395,250
|
|
|
$
|
12.96
|
|
(4)
|
231,090
|
|
Total
|
|
25,971,436
|
|
|
$
|
5.84
|
|
|
25,612,135
|
|
(1 )
|
Equity plans approved by our shareholders are the 2000 Plan, the 2011 Plan, the 2014 Plan, the Director Plan, the 2017 Plan and the ESPP. As of December 31, 2017, a total of
5,052,500
shares of our common stock remained available for issuance under the ESPP, and up to a maximum of 437,237 shares of our common stock may be purchased in the current purchase period. The shares issuable pursuant to our ESPP are not included in the number of shares to be issued pursuant to rights outstanding or and the weighted-average exercise price of such rights as of December 29, 2017, as those numbers are not known.
|
(2)
|
The weighted-average exercise price takes into account the shares subject to outstanding restricted stock units, or RSUs, which have no exercise price. The weighted-average exercise price, excluding such outstanding RSUs, is $6.68.
|
(3)
|
Represents shares of our common stock issuable pursuant to the 2016 Plan and 401(k) Plan.
|
(4)
|
The weighted-average exercise price takes into account the shares subject to outstanding RSUs, which have no exercise price. The weighted-average exercise price, excluding such outstanding RSUs, is $19.44.
|
(a)
|
The following documents are being filed as part of this report:
|
(1)
|
The following financial statements and the Report of Independent Registered Public Accounting Firm are included in Part II, Item 8:
|
|
Page
|
(2)
|
All financial statement schedules are omitted because the information is inapplicable or presented in the Notes to Consolidated Financial Statements.
|
(3)
|
The following Exhibits are filed as part of this report.
|
Exhibit
Number
|
|
Exhibit Description
|
|
Incorporation by Reference
|
|
Filed
Herewith
|
||||||
Form
|
|
File Number
|
|
Exhibit/
Appendix
Reference
|
|
Filing Date
|
|
|||||
3.1
|
|
|
10-K
|
|
000-30235
|
|
3.1
|
|
3/10/2010
|
|
|
|
3.2
|
|
|
10-K
|
|
000-30235
|
|
3.2
|
|
3/10/2010
|
|
|
|
3.3
|
|
|
8-K
|
|
000-30235
|
|
3.1
|
|
5/25/2012
|
|
|
|
3.4
|
|
|
8-K
|
|
000-30235
|
|
3.2
|
|
10/15/2014
|
|
|
|
3.5
|
|
|
8-K
|
|
000-30235
|
|
3.1
|
|
10/15/2014
|
|
|
|
3.6
|
|
|
8-K
|
|
000-30235
|
|
3.1
|
|
12/5/2011
|
|
|
|
4.1
|
|
|
S-1,
as amended
|
|
333-96335
|
|
4.1
|
|
4/7/2000
|
|
|
|
10.1†
|
|
|
S-1,
as amended
|
|
333-96335
|
|
10.1
|
|
3/17/2000
|
|
|
|
10.2
†
|
|
|
10-Q
|
|
000-30235
|
|
10.1
|
|
5/3/2007
|
|
|
|
10.3
†
|
|
|
10-Q
|
|
000-30235
|
|
10.2
|
|
11/8/2004
|
|
|
|
10.4
†
|
|
|
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
†
|
|
|
10-K
|
|
000-30235
|
|
10.6
|
|
2/20/2014
|
|
|
|
10.6
†
|
|
|
10-K
|
|
000-30235
|
|
10.7
|
|
2/22/2011
|
|
|
|
10.7
†
|
|
|
Schedule 14A
|
|
000-30235
|
|
A
|
|
4/13/2016
|
|
|
|
10.8
†
|
|
|
8-K
|
|
000-30235
|
|
10.1
|
|
5/24/2011
|
|
|
|
10.9
†
|
|
|
10-Q
|
|
000-30235
|
|
10.3
|
|
8/4/2011
|
|
|
|
10.10
†
|
|
|
10-Q
|
|
000-30235
|
|
10.4
|
|
8/4/2011
|
|
|
|
10.11
†
|
|
|
8-K
|
|
000-30235
|
|
10.1
|
|
5/29/2014
|
|
|
|
10.12
†
|
|
|
10-Q
|
|
000-30235
|
|
10.2
|
|
7/31/2014
|
|
|
|
10.13
†
|
|
|
10-Q
|
|
000-30235
|
|
10.3
|
|
7/31/2014
|
|
|
|
10.14
†
|
|
|
10-Q
|
|
000-30235
|
|
10.4
|
|
7/31/2014
|
|
|
|
10.15
†
|
|
|
10-Q
|
|
000-30235
|
|
10.5
|
|
7/31/2014
|
|
|
|
10.16
†
|
|
|
8-K
|
|
000-30235
|
|
10.1
|
|
10/16/2014
|
|
|
|
10.17
†
|
|
|
8-K
|
|
000-30235
|
|
10.1
|
|
11/22/2016
|
|
|
|
10.18
†
|
|
|
8-K
|
|
000-30235
|
|
10.2
|
|
11/22/2016
|
|
|
|
10.19
†
|
|
|
8-K
|
|
000-30235
|
|
10.2
|
|
11/22/2016
|
|
|
|
10.20
†
|
|
|
|
|
|
|
|
|
|
|
X
|
|
10.21
†
|
|
|
|
|
|
|
|
|
|
|
X
|
|
10.22
†
|
|
|
|
|
|
|
|
|
|
|
X
|
|
10.23
†
|
|
|
|
|
|
|
|
|
|
|
X
|
Exhibit
Number
|
|
Exhibit Description
|
|
Incorporation by Reference
|
|
Filed
Herewith
|
||||||
Form
|
|
File Number
|
|
Exhibit/
Appendix
Reference
|
|
Filing Date
|
|
|||||
10.24
†
|
|
|
|
|
|
|
|
|
|
|
X
|
|
10.25
†
|
|
|
|
|
|
|
|
|
|
|
X
|
|
10.26
†
|
|
|
10-Q
|
|
000-30235
|
|
10.43
|
|
8/5/2004
|
|
|
|
10.27
†
|
|
|
10-Q
|
|
000-30235
|
|
10.5
|
|
11/10/2015
|
|
|
|
10.28
†
|
|
|
8-K
|
|
000-30235
|
|
10.1
|
|
6/26/2006
|
|
|
|
10.29
†
|
|
|
10-Q
|
|
000-30235
|
|
10.4
|
|
5/1/2014
|
|
|
|
10.30
†
|
|
|
10-K
|
|
000-30235
|
|
10.24
|
|
2/29/2016
|
|
|
|
10.31
†
|
|
|
10-K
|
|
000-30235
|
|
10.26
|
|
2/27/2017
|
|
|
|
10.32
†
|
|
|
10-Q
|
|
000-30235
|
|
10.1
|
|
11/4/2010
|
|
|
|
10.33
†
|
|
|
8-K
|
|
000-30235
|
|
Item 5.02 disclosure
|
|
2/16/2018
|
|
|
|
10.34
†
|
|
|
8-K
|
|
000-30235
|
|
10.1
|
|
2/16/2018
|
|
|
|
10.35
†
|
|
|
|
|
|
|
|
|
|
|
X
|
|
10.36
†
|
|
|
10-Q
|
|
000-30235
|
|
10.4
|
|
11/1/2017
|
|
|
|
10.37
|
|
|
8-K
|
|
000-30235
|
|
10.1
|
|
5/27/2005
|
|
|
|
10.38
|
|
|
10-Q
|
|
000-30235
|
|
10.1
|
|
8/2/2017
|
|
|
|
10.39
|
|
|
|
|
|
|
|
|
|
|
X
|
Exhibit
Number
|
|
Exhibit Description
|
|
Incorporation by Reference
|
|
Filed
Herewith
|
||||||
Form
|
|
File Number
|
|
Exhibit/
Appendix
Reference
|
|
Filing Date
|
|
|||||
10.40*
|
|
|
10-K
|
|
000-30235
|
|
10.45
|
|
2/27/2017
|
|
|
|
10.41
|
|
|
10-K
|
|
000-30235
|
|
10.46
|
|
2/27/2017
|
|
|
|
10.42
|
|
|
10-K
|
|
000-30235
|
|
10.47
|
|
2/27/2017
|
|
|
|
10.43*
|
|
|
10-Q/A
|
|
000-30235
|
|
10.3
|
|
9/30/2016
|
|
|
|
10.44*
|
|
|
10-K
|
|
000-30235
|
|
10.49
|
|
2/27/2017
|
|
|
|
10.45*
|
|
|
10-Q
|
|
000-30235
|
|
10.2
|
|
11/1/2017
|
|
|
|
10.46**
|
|
|
|
|
|
|
|
|
|
|
X
|
|
10.47*
|
|
|
10-Q/A
|
|
000-30235
|
|
10.4
|
|
9/30/2016
|
|
|
Exhibit
Number
|
|
Exhibit Description
|
|
Incorporation by Reference
|
|
Filed
Herewith
|
||||||
Form
|
|
File Number
|
|
Exhibit/
Appendix
Reference
|
|
Filing Date
|
|
|||||
10.48**
|
|
|
|
|
|
|
|
|
|
|
X
|
|
10.49*
|
|
|
10-K
|
|
000-30235
|
|
10.51
|
|
2/27/2017
|
|
|
|
10.50*
|
|
|
10-K
|
|
000-30235
|
|
10.52
|
|
2/27/2017
|
|
|
|
10.51
|
|
|
10-Q
|
|
000-30235
|
|
10.5
|
|
8/5/2010
|
|
|
|
10.52*
|
|
|
10-Q
|
|
000-30235
|
|
10.5
|
|
8/2/2017
|
|
|
|
10.53*
|
|
|
10-Q/A
|
|
000-30235
|
|
10.1
|
|
7/14/2017
|
|
|
|
10.54*
|
|
|
10-Q
|
|
000-30235
|
|
10.2
|
|
5/1/2017
|
|
|
|
10.55*
|
|
|
10-Q
|
|
000-30235
|
|
10.3
|
|
5/1/2017
|
|
|
|
12.1
|
|
|
|
|
|
|
|
|
|
|
X
|
|
21.1
|
|
|
|
|
|
|
|
|
|
|
X
|
|
23.1
|
|
|
|
|
|
|
|
|
|
|
X
|
|
24.1
|
|
|
|
|
|
|
|
|
|
|
X
|
|
31.1
|
|
|
|
|
|
|
|
|
|
|
X
|
|
31.2
|
|
|
|
|
|
|
|
|
|
|
X
|
|
32.1‡
|
|
|
|
|
|
|
|
|
|
|
X
|
Exhibit
Number
|
|
Exhibit Description
|
|
Incorporation by Reference
|
|
Filed
Herewith
|
||||||
Form
|
|
File Number
|
|
Exhibit/
Appendix
Reference
|
|
Filing Date
|
|
|||||
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.
|
**
|
Confidential treatment requested 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.
|
|
|
E
XELIXIS
, I
NC
.
|
|
|
|
|
|
February 26, 2018
|
|
By:
|
/s/ M
ICHAEL
M. M
ORRISSEY
|
Date
|
|
|
Michael M. Morrissey, Ph.D.
|
|
|
|
President and Chief Executive Officer
|
Signatures
|
|
Title
|
|
Date
|
|
|
|
||
/s/ M
ICHAEL
M. M
ORRISSEY
|
|
Director, President and
Chief Executive Officer
|
|
February 26, 2018
|
Michael M. Morrissey, Ph.D.
|
|
(Principal Executive Officer)
|
|
|
|
|
|
||
/s/ C
HRISTOPHER
J. S
ENNER
|
|
Executive Vice President and
Chief Financial Officer
|
|
February 26, 2018
|
Christopher J. Senner
|
|
(Principal Financial and
Accounting Officer)
|
|
|
|
|
|
||
/s/ S
TELIOS
P
APADOPOULOS
|
|
Chairman of the Board
|
|
February 26, 2018
|
Stelios Papadopoulos, Ph.D.
|
|
|
|
|
|
|
|
||
/s/ C
HARLES
C
OHEN
|
|
Director
|
|
February 26, 2018
|
Charles Cohen, Ph.D.
|
|
|
|
|
|
|
|
||
/s/ C
ARL
B. F
ELDBAUM
|
|
Director
|
|
February 26, 2018
|
Carl B. Feldbaum, Esq.
|
|
|
|
|
|
|
|
||
/s/ A
LAN
M. G
ARBER
|
|
Director
|
|
February 26, 2018
|
Alan M. Garber, M.D., Ph.D.
|
|
|
|
|
Signatures
|
|
Title
|
|
Date
|
|
|
|
||
/s/ V
INCENT
T. M
ARCHESI
|
|
Director
|
|
February 26, 2018
|
Vincent T. Marchesi, M.D., Ph.D.
|
|
|
|
|
|
|
|
||
/s/ G
EORGE
P
OSTE
|
|
Director
|
|
February 26, 2018
|
George Poste, D.V.M., Ph.D.
|
|
|
|
|
|
|
|
||
/s/ G
EORGE
A. S
CANGOS
|
|
Director
|
|
February 26, 2018
|
George A. Scangos, Ph.D.
|
|
|
|
|
|
|
|
|
|
/s/ J
ULIE
A. S
MITH
|
|
Director
|
|
February 26, 2018
|
Julie A. Smith
|
|
|
|
|
|
|
|
||
/s/ L
ANCE
W
ILLSEY
|
|
Director
|
|
February 26, 2018
|
Lance Willsey, M.D.
|
|
|
|
|
|
|
|
||
/s/ J
ACK
L. W
YSZOMIERSKI
|
|
Director
|
|
February 26, 2018
|
Jack L. Wyszomierski
|
|
|
|
|
Board of Directors
|
Retainer Fee
|
|
$50,000
|
|
Additional Chair Retainer Fee
|
|
$30,000
|
|
|
Meeting Fee
12
|
|
$2,500
|
|
|
Audit Committee
|
Retainer Fee
|
|
$10,000
|
|
Additional Chair Retainer Fee
|
|
$15,000
|
|
|
Meeting Fee
13
|
|
$1,000
|
|
|
Compensation Committee
|
Retainer Fee
|
|
$8,000
|
|
Additional Chair Retainer Fee
|
|
$12,000
|
|
|
Meeting Fee
13
|
|
$1,000
|
|
|
Nominating & Corporate Governance Committee
|
Retainer Fee
|
|
$5,000
|
|
Additional Chair Retainer Fee
|
|
$10,000
|
|
|
Meeting Fee
14
|
|
$1,000
|
|
|
Research & Development Committee
|
Retainer Fee
|
|
$5,000
|
|
Additional Chair Retainer Fee
|
|
$10,000
|
|
|
Meeting Fee
14
|
|
$1,000
|
|
1
|
Meetings for which minutes are generated count toward the meeting threshold to determine when Meeting Fees are to be paid.
|
2
|
Meeting Fee paid for all meetings in excess of eight meetings.
|
3
|
Meeting Fee paid for all meetings in excess of seven meetings.
|
4
|
Meeting Fee paid for all meetings in excess of four meetings.
|
Period
|
Monthly Rental Rate / SF of Rentable Area
|
|
Base Rent Payable Per Month
|
|
||
February 1, 2018 –Day before Additional 1801 Space Start Date
|
|
$1.65
|
|
$187,251.90*
|
|
|
Additional 1801 Space Start Date – January 31, 2019
|
|
$1.65
|
|
$215,425.65*
|
|
|
February 1, 2019 – January 31, 2020
|
|
$1.70
|
|
|
$221,953.70
|
|
February 1, 2020 – January 31, 2021
|
|
$1.75
|
|
|
$228,481.75
|
|
February 1, 2021 – January 31, 2022
|
|
$1.80
|
|
|
$235,009.80
|
|
February 1, 2022 – January 31, 2023
|
|
$1.86
|
|
|
$242,843.46
|
|
February 1, 2023 – January 31, 2024
|
|
$1.91
|
|
|
$249,371.51
|
|
February 1, 2024 – January 31, 2025
|
|
$1.97
|
|
|
$257,205.17
|
|
February 1, 2025 – January 31, 2026
|
|
$2.03
|
|
|
$265,038.83
|
|
February 1, 2026 – January 31, 2027
|
|
$2.09
|
|
|
$272,872.49
|
|
February 1, 2027 – January 31, 2028
|
|
$2.15
|
|
|
$280,706.15
|
|
LANDLORD:
|
ASCENTRIS 105, LLC,
a Colorado limited liability company
By:
/s/Gabe L. Fink
Name: Gabe L. Fink Title: Manager |
TENANT:
|
EXELIXIS, INC.,
a Delaware corporation
By:
/s/Michael M. Morrissey, Ph.D
Name: Michael M. Morrissey, Ph.D Title: President & CEO |
EXELIXIS, INC.
By: /s/ Michael M. Morrissey
Name: Michael M. Morrissey, Ph.D.
Title: President and CEO
|
IPSEN PHARMA S.A.S
By: /s/ Christophe Jean
Name: Christophe Jean
Title: EVP Corporate Strategy & Business Development
|
EXELIXIS, INC.
By: /s/ Michael M. Morrissey
Name: Michael M. Morrissey, Ph.D.
Title: President and CEO
|
IPSEN PHARMA S.A.S
By: /s/ Christophe Jean
Name: Christophe Jean
Title: EVP Corporate Strategy & Business Development
|
|
Year Ended December 31,
|
||||||||||||||||||
|
2017
|
|
2016
|
|
2015
|
|
2014
|
|
2013
|
||||||||||
Fixed charges:
|
|
|
|
|
|
|
|
|
|
||||||||||
Interest expense
|
$
|
8,679
|
|
|
$
|
33,060
|
|
|
$
|
40,680
|
|
|
$
|
41,362
|
|
|
$
|
38,779
|
|
Interest portion of rental expense
|
592
|
|
|
721
|
|
|
755
|
|
|
886
|
|
|
935
|
|
|||||
Total fixed charges
|
$
|
9,271
|
|
|
$
|
33,781
|
|
|
$
|
41,435
|
|
|
$
|
42,248
|
|
|
$
|
39,714
|
|
Earnings available for fixed charges:
|
|
|
|
|
|
|
|
|
|
||||||||||
Net income (loss) before income taxes
|
$
|
158,577
|
|
|
$
|
(70,222
|
)
|
|
$
|
(161,744
|
)
|
|
$
|
(261,297
|
)
|
|
$
|
(238,192
|
)
|
Fixed charges per above
|
9,271
|
|
|
33,781
|
|
|
41,435
|
|
|
42,248
|
|
|
39,714
|
|
|||||
Total earnings available for fixed charges
|
$
|
167,848
|
|
|
$
|
(36,441
|
)
|
|
$
|
(120,309
|
)
|
|
$
|
(219,049
|
)
|
|
$
|
(198,478
|
)
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Ratio of earnings to fixed charges
|
18.10
|
|
|
N/A
|
|
N/A
|
|
N/A
|
|
N/A
|
|||||||||
Deficiency of earnings available to cover fixed charges
|
N/A
|
|
$
|
(70,222
|
)
|
|
$
|
(161,744
|
)
|
|
$
|
(261,297
|
)
|
|
$
|
(238,192
|
)
|
Name of Subsidiary
|
State or Other Jurisdiction of Incorporation or Organization
|
Exelixis Global Services, Inc.
|
Delaware
|
Exelixis International (Bermuda) Ltd.
|
Bermuda
|
Exelixis Patent Company, LLC
|
Delaware
|
Exelixis Plant Sciences, Inc.
|
Delaware
|
Exelixis U.S., LLC
|
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)
|