FORM 10-K
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ý
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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¨
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Delaware
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23-2908305
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(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer
Identification No.)
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6154 Nancy Ridge Drive, San Diego, CA
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92121
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(Address of principal executive offices)
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(Zip Code)
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Title of each class
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Name of each exchange on which registered
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Common Stock, $0.0001 par value
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NASDAQ Global Select Market
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Large accelerated filer
x
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Accelerated filer
¨
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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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•
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Advance our proprietary clinical programs:
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◦
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APD334 - a modulator of the sphingosine 1-phosphate subtype 1, or S1P
1
, receptor
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◦
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Ralinepag - an agonist of the prostacyclin, or IP, receptor
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◦
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APD371 - an agonist of the cannabinoid-2, or CB
2
, receptor
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•
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Pursue strategic collaborations for certain clinical and pre-clinical programs
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Discover and develop additional pre-clinical drug candidates
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Support Eisai and our other collaborators in their BELVIQ efforts, including their work to:
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◦
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Complete the cardiovascular outcomes trial, or CVOT, to assess the effect of BELVIQ on major adverse cardiovascular events and a possible reduction in conversion to Type 2 diabetes compared to placebo
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Obtain regulatory approval for BELVIQ XR
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◦
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Obtain regulatory approval in additional territories
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•
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30 kg/m
2
or greater (obese), or
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•
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27 kg/m
2
or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes).
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The safety and efficacy of coadministration of BELVIQ with other products intended for weight loss, including prescription drugs (e.g., phentermine), over-the-counter drugs, and herbal preparations, have not been established.
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The effect of BELVIQ on cardiovascular morbidity and mortality has not been established.
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30 kg/m
2
or greater (obese), or
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27 kg/m
2
or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes).
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United States
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Rest of
North and South America
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Remaining Territories
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BELVIQ
- Pre-approval*
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Not Applicable
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General
Eisai: 90%; Arena: 10%
Certain stability work
Eisai: 50%; Arena: 50%
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Up to total of $100.0 million** - Eisai: 50%; Arena: 50%
Thereafter, Eisai: 100%
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BELVIQ
- Post-approval*
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General
Eisai: 90%; Arena 10%
Non-FDA required portion of CVOT
Up to $80.0 million -
Eisai: 50%; Arena: 50%
Thereafter, Eisai: 100%
Certain pediatric studies
Eisai: 50%; Arena: 50%
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General
Eisai: 90%; Arena: 10%
Certain stability work
Eisai: 50%; Arena: 50%
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Up to total of $50.0 million -
Eisai: 50%; Arena: 50%
Thereafter, Eisai: 90%;
Arena: 10%
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Lorcaserin
products other than
BELVIQ
- Pre-approval
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Up to a total of $250.0 million (as reduced by up to $80.0 million for non-FDA required portion of CVOT)**
- Eisai: 50%; Arena: 50%
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Lorcaserin
products other than
BELVIQ
- Post-approval
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Up to a total of $100.0 million in the aggregate across all additional products -
Eisai: 50%; Arena: 50%
Thereafter, Eisai: 90%; Arena: 10%
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*
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Development required by a regulatory authority, with the exception of the non-FDA required portion of the CVOT.
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**
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Under the collaborative agreement, the amount for BELVIQ pre-approval in the Remaining Territories was decreased and the amount for lorcaserin products other than BELVIQ pre-approval was increased by such amount.
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completion of extensive preclinical laboratory tests and preclinical animal studies, many of which are required to be performed in accordance with the FDA’s Good Laboratory Practice, or GLP, regulations;
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submission to the FDA of an IND, which must become effective before human clinical trials may begin and be updated annually;
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performance of adequate and well-controlled human clinical trials to establish the safety and efficacy of the drug candidate for each proposed indication;
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submission to the FDA of an NDA after completion of adequate and well-controlled human clinical trials, generally accompanied by payment of a substantial user fee to the FDA;
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a determination by the FDA within 60 days of its receipt of the NDA to file the NDA for review;
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satisfactory completion of an FDA pre-approval inspection of the manufacturing facilities at which the active pharmaceutical ingredient and finished drug product are produced and tested to assess compliance with Current Good Manufacturing Practices, or cGMP, regulations; and
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FDA review and approval of the NDA prior to any commercial marketing or sale of the drug in the United States.
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Prior to commercialization, centrally acting drugs may be subject to review and potential scheduling by the DEA.
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Phase 1 clinical trials. Studies are initially conducted in a limited population to test the drug candidate for safety, dose tolerance, absorption, metabolism, distribution and excretion, typically in healthy volunteers, but in some cases in patients.
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Phase 2 clinical trials. Studies are generally conducted in a limited patient population to identify possible adverse effects and safety risks, explore the initial efficacy of the product for specific targeted indications and to determine dose range or pharmacodynamics. 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.
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Phase 3 clinical trials. These are commonly referred to as pivotal studies or adequate and well-controlled studies. When Phase 2 evaluations demonstrate that a dose range of the product is effective and has an acceptable safety profile, Phase 3 clinical trials are undertaken in large patient populations to further evaluate dosage, provide substantial evidence of clinical efficacy and further test for safety in an expanded and diverse patient population at multiple, geographically dispersed clinical trial centers.
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Phase 4 clinical trials. The FDA may approve an NDA for a drug candidate, but require that the sponsor conduct additional clinical trials to further assess the drug after NDA approval under a post-approval commitment. In addition, a sponsor may decide to conduct additional clinical trials after the FDA has approved an NDA. Post-approval trials are typically referred to as Phase 4 clinical trials.
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the number of patients eligible to receive BELVIQ, the number of patients treated with BELVIQ and the results achieved by such patients;
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market acceptance and use of BELVIQ, which may depend on the public’s view of BELVIQ, economic changes, national and world events, potentially seasonal and other fluctuations in demand, the timing and impact of current or new competition, and BELVIQ’s perceived advantages or disadvantages over alternative treatments (including relative convenience, ease of administration, and prevalence and severity of any adverse events, including any unexpected adverse events);
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the actual and perceived safety and efficacy of BELVIQ on both a short- and long-term basis among actual or potential patients, healthcare providers and others in the medical community, regulatory agencies and insurers and other payers, including related decisions by any such entity or individual;
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incidence and severity of any side effects, including as a result of off-label use or in combination with one or more drugs;
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new data relating to lorcaserin, including as a result of additional studies, trials or analyses of lorcaserin or related drugs or drug candidates;
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some physicians and patients may not use BELVIQ until at least results from our required postmarketing studies are available or other long-term efficacy and safety data exists;
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the claims, limitations, warnings and other information in BELVIQ’s current or future labeling;
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the current or future scheduling designation for BELVIQ by the US Drug Enforcement Administration, or DEA, or any comparable foreign authorities;
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Our collaborator’s maintenance of an effective sales force, marketing team, strategy and program and medical affairs group and related functions, as well as its sales, marketing and other representatives accurately describing BELVIQ consistent with its approved labeling;
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the price and perceived cost-effectiveness of BELVIQ, including as compared to possible alternatives;
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the ability of patients and physicians and other providers to obtain and maintain coverage and adequate reimbursement, if any, by third-party payers, including government payers;
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the ability and desire of group purchasing organizations, or GPOs, including distributors and other network providers, to sell BELVIQ to their constituencies;
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introduction of counterfeit or unauthorized versions of BELVIQ;
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the development of the market for weight-management medications;
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to the extent BELVIQ is approved and marketed in a jurisdiction with a significantly lower price than in another jurisdiction, the impact of the lower pricing in the higher-priced territory, including on the pricing of reimbursement, if available, and by the diversion of lower-priced BELVIQ into the higher-priced territory; and
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the maintenance of adequate commercial manufacturing capabilities ourselves or through third-party manufacturers, our ability to meet commercial demand for BELVIQ and supply-chain issues.
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the rate of adoption in the particular market, including fluctuations in demand for various reasons, such as fluctuations related to economic changes, national and world events, holidays and seasonal changes;
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pricing (including discounting or other promotions), reimbursement, product returns or recalls, competition, labeling, DEA scheduling, adverse events and others items that impact commercialization;
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lack of patient and physician familiarity with BELVIQ;
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lack of patient use and physician prescribing history;
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lack of commercialization experience with BELVIQ, in particular, and weight loss or management drugs, in general;
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actual sales to patients may significantly differ from expectations based on sales to wholesalers;
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our collaborators control the commercialization of BELVIQ in most of the world, including related strategy and their allocation of resources, and we expect that any future collaborators for BELVIQ will similarly control the commercialization in the applicable territory; and
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uncertainty relating to when BELVIQ may become commercially available to patients and rate of adoption in other territories.
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our collaborators may not comply with applicable regulatory guidelines with respect to lorcaserin, which could adversely impact the commercialization or development of lorcaserin;
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there could be disagreements regarding the agreements or the study or development of lorcaserin that delay or terminate the commercialization, research, study or development of lorcaserin, delay or eliminate potential payments under the agreements or increase our costs under or outside of the agreements;
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our collaborators may not effectively allocate adequate resources or otherwise support lorcaserin or may have limited experience in a particular territory; and
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our collaborators may not perform as expected, including with regard to making any required payments, and the agreements may not provide adequate protection or may not be effectively enforced.
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availability or contamination of raw materials and components used in the manufacturing process, particularly those for which we have no other source or supplier;
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capacity of our facilities or those of our contract manufacturers;
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having the ability to adjust to changes in actual or anticipated use of the facility, including with respect to having sufficient capacity and a sufficient number of qualified personnel;
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facility contamination by microorganisms or viruses or cross contamination;
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compliance with regulatory requirements, including inspectional notices of violation and warning letters;
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maintenance and renewal of any required licenses or certifications;
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changes in actual or forecasted demand;
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timing and number of production runs;
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production success rates and bulk drug yields; and
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timing and outcome of product quality testing.
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a drug candidate may not be deemed adequately safe and effective;
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FDA officials may not find the data from preclinical studies and clinical trials sufficient;
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the FDA’s interpretation and our interpretation of data from preclinical studies and clinical trials may differ significantly;
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our or our contractors’ or collaborators’ failure to comply with applicable FDA and other regulatory requirements, including those identified in other risk factors;
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the FDA may not approve the manufacturing processes or facilities;
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the FDA may change its approval policies or adopt new regulations; or
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the FDA may not accept an NDA or other submission due to, among other reasons, the content or formatting of the submission.
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issuance of inspectional notices of violation or warning letters by any regulatory agency;
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imposition of fines and other civil penalties;
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criminal prosecutions;
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injunctions, suspensions or revocations of regulatory approvals;
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suspension of any ongoing clinical trials;
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total or partial suspension of manufacturing;
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delays in commercialization;
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refusal by any regulatory agency to approve pending applications or supplements to approved applications filed by us or collaborators;
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refusals to permit drugs or related materials to be imported into or exported from the United States or other countries;
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restrictions on operations, including costly new manufacturing requirements; and
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product recalls or seizures.
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timing of market introduction of our drugs and competitive drugs and alternative treatments;
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actual and perceived efficacy and safety of our drugs;
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incidence and severity of any side effects;
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potential or perceived advantages or disadvantages as compared to alternative treatments;
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effectiveness of sales, marketing and distribution support;
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price of our future products, both in absolute terms and relative to alternative treatments;
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the general marketplace for the particular drug;
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the effect of current and future healthcare laws on our drug candidates;
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availability of coverage and adequate reimbursement from government and other third-party payers; and
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product labeling or product insert requirements of the FDA or other regulatory authorities.
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limited number of, and competition for, suitable patients required for enrollment in our clinical trials or animals to conduct our preclinical studies;
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limited number of, and competition for, suitable sites to conduct our clinical trials or preclinical studies;
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delay or failure to obtain approval or agreement from the applicable regulatory authority to commence a clinical trial or approval of a study protocol;
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delay or failure to obtain sufficient supplies of drug candidates, drugs or other materials for the trial or study;
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delay or failure to reach agreement on acceptable agreement terms or protocols; and
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delay or failure to obtain institutional review board, or IRB, approval to conduct a clinical trial at a prospective site.
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lack of effectiveness of any drug candidate during clinical trials;
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side effects experienced by study participants or other safety issues;
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slower than expected rates of patient recruitment and enrollment or lower than expected patient retention rates;
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delays or inability to manufacture or obtain sufficient quantities of materials for use in clinical trials;
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inadequacy of or changes in our manufacturing process or compound formulation;
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delays in obtaining regulatory approvals to commence a study, or “clinical holds,” or delays requiring suspension or termination of a study by a regulatory authority, such as the FDA, after a study is commenced;
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changes in applicable regulatory policies and regulations;
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delays in identifying and reaching agreement on acceptable terms with prospective clinical trial sites;
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uncertainty regarding proper dosing;
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unfavorable results from ongoing clinical trials or preclinical studies;
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failure of our clinical research organizations to comply with all regulatory and contractual requirements or otherwise perform their services in a timely or acceptable manner;
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scheduling conflicts with participating clinicians and clinical institutions;
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failure to design appropriate clinical trial protocols;
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insufficient data to support regulatory approval;
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termination of clinical trials at one or more clinical trial sites;
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inability or unwillingness of medical investigators to follow our clinical protocols;
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difficulty in maintaining contact with subjects during or after treatment, which may result in incomplete data;
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lack of sufficient funding to continue clinical trials or preclinical studies; or
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changes in business priorities or perceptions of the value of the program.
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unwillingness on the part of a collaborator to pay for studies or other research, milestones, royalties or other payments that we believe are due to us under a collaboration;
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uncertainty regarding ownership of intellectual property rights arising from our collaborative activities, which could prevent us from entering into additional collaborations;
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unwillingness on the part of a collaborator to keep us informed regarding the progress of its development, regulatory, commercialization, pharmacovigilance or other activities or to permit public disclosure of the results of those activities;
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slowing or cessation of a collaborator’s research, development, regulatory or commercialization efforts with respect to our drug candidates or drugs; or
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litigation or arbitration.
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decreased demand for our drug;
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injury to our reputation;
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increased difficulty to attract, or withdrawal of, clinical trial subjects;
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costs of related litigation;
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substantial monetary awards to subjects or other claimants;
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loss of revenues; and
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the inability to commercialize our drug candidates.
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increasing our vulnerability to general adverse economic conditions;
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limiting our ability to obtain additional funds;
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placing us at a possible competitive disadvantage to less leveraged competitors and competitors that have better access to capital resources; and
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litigation or other disagreements.
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interruption of our research, development or manufacturing efforts;
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injury to our employees and others;
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environmental damage resulting in costly clean up; and
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liabilities under domestic or foreign laws and regulations governing the use, storage, handling and disposal of these materials and specified waste products.
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require us, or our collaborators, to obtain a license to continue to use, manufacture or market the affected drugs, methods or processes, which may not be available on commercially reasonable terms, if at all;
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prevent us from importing, making, using, selling or offering to sell the subject matter claimed in patents held by others and subject us to potential liability for damages;
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consume a substantial portion of our managerial, scientific and financial resources; or
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be costly, regardless of the outcome.
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regulatory actions or decisions or legislation affecting lorcaserin, including decisions of regulatory authorities relating to lorcaserin, or other drugs or drug candidates, including those of our competitors;
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the commercial availability and success or failure of BELVIQ (including perceptions of prescription trends or other information) or any of our drug candidates;
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the entrance into, or failure to enter into, a new collaboration or the modification or termination of an existing collaboration or other material transaction;
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the timing and receipt by us of milestone and other payments or failing to achieve and receive the same;
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fluctuation in prescriptions, sales or financial results (including with respect to revenue recognition) or inaccurate sales or cash forecasting;
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accounting restatements and changes;
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supply chain or manufacturing issues;
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discussions or recommendations affecting our drugs or drug candidates by FDA advisory committees or other reviewers of preclinical or clinical data or other information related to lorcaserin, drug candidates or other drugs;
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results or decisions affecting the development or commercialization of BELVIQ or any of our drug candidates, including the results of studies, trials and other analyses;
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the development and implementation of our continuing development and research plans, including outcome studies and other research and development for lorcaserin (including related development programs);
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the timing of the discovery of drug leads and the development of our drug candidates;
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changes in our research and development budget or the research and development budgets of our existing or potential collaborators;
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the introduction, development or withdrawal of drug candidates or drugs by others that target the same diseases and conditions that we or our collaborators target or the introduction of new drug discovery techniques;
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the success, failure or setbacks of our or a perceived competitor’s drugs or drug candidates;
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expenses related to, and the results of, litigation, other disputes and other proceedings;
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financing strategy or decisions;
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developments in intellectual property rights or related announcements; and
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capital market conditions.
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allow our board of directors to issue preferred stock without stockholder approval;
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limit who can call a special meeting of stockholders;
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eliminate stockholder action by written consent; and
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establish advance notice requirements for nomination for election to the board of directors or for proposing matters to be acted upon at stockholders’ meetings.
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Location
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Own/ Lease
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Description
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6114 Nancy Ridge Drive
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Lease with option to purchase
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This chemical development facility consists of approximately 40,000 square feet (which includes approximately 18,000 of internal square feet and approximately 22,000 square feet of integrated external space), of which approximately 5,000 square feet is office space. The remaining approximately 35,000 square feet of space is dedicated to process research and scale-up chemistry, the production of intermediates and other compounds for research and development purposes, and the production of active pharmaceutical ingredients to support our clinical trials.
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6118 Nancy Ridge Drive
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Lease with option to purchase
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This facility of approximately 30,000 square feet consists of approximately 50% laboratory space and 50% office space, which is substantially unoccupied.
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6122-6124-6126 Nancy
Ridge Drive
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Lease with option to purchase
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This facility of approximately 68,000 square feet consists of approximately 28,500 square feet of laboratory space, 28,500 square feet of office space, 9,000 square feet of unoccupied space and 2,000 square feet of warehouse space.
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6138-6150 Nancy Ridge
Drive
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Lease with option to purchase
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This facility of approximately 55,000 square feet consists of approximately 33,000 square feet of laboratory space and 22,000 square feet of office space.
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6154 Nancy Ridge Drive
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Lease with option to purchase
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This facility of approximately 143,000 square feet consists of approximately 131,000 square feet of office space and 12,000 square feet of warehouse space, which is substantially unoccupied.
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Zofingen, Switzerland
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Own
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This facility of approximately 134,000 square feet includes approximately 76,000 square feet we occupy of which 39,000 square feet is manufacturing space, 30,000 square feet is warehouse space and 7,000 square feet is office space. We lease the remaining 58,000 square feet of warehouse space to Siegfried AG, or Siegfried.
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Zofingen, Switzerland
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Lease
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We lease from Siegfried a total of approximately 19,000 square feet, consisting of approximately 11,000 square feet of office space, 5,000 square feet of warehouse space and 3,000 square feet of laboratory space, in various facilities.
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High
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Low
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||||
Year ended December 31, 2015
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||||
First Quarter
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$
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6.28
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$
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3.30
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Second Quarter
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$
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4.79
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$
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3.90
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Third Quarter
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$
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5.12
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$
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1.86
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Fourth Quarter
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$
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2.68
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$
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1.60
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Years ended December 31,
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2015
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2014
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2013
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2012
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2011
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(In thousands, except share and per share data)
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Revenues
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Net product sales
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$
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19,726
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$
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15,983
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$
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5,702
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$
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0
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$
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0
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Other Eisai collaborative revenue
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9,505
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18,611
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72,416
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23,617
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6,770
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Toll manufacturing
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4,250
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1,497
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2,690
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3,817
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5,338
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Other collaborative revenue
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4,845
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879
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586
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153
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611
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Total revenues
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38,326
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36,970
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81,394
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27,587
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12,719
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Operating Costs and Expenses
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Cost of product sales
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8,590
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6,369
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1,803
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0
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0
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Cost of toll manufacturing
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4,585
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1,390
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4,377
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3,671
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8,100
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Research and development
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88,411
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100,347
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66,468
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54,112
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58,706
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General and administrative
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35,966
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34,137
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31,681
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26,226
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24,248
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Restructuring charges
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3,972
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0
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|
0
|
|
|
0
|
|
|
3,467
|
|
|||||
Amortization of intangibles
|
0
|
|
|
0
|
|
|
0
|
|
|
691
|
|
|
997
|
|
|||||
Total operating costs and expenses
|
141,524
|
|
|
142,243
|
|
|
104,329
|
|
|
84,700
|
|
|
95,518
|
|
|||||
Interest and other income (expense), net
|
(4,781
|
)
|
|
44,765
|
|
|
3,500
|
|
|
(28,364
|
)
|
|
(26,425
|
)
|
|||||
Net loss
|
(107,979
|
)
|
|
(60,508
|
)
|
|
(19,435
|
)
|
|
(85,477
|
)
|
|
(109,224
|
)
|
|||||
Deemed dividends related to beneficial conversion feature of convertible preferred stock
|
0
|
|
|
0
|
|
|
0
|
|
|
(2,824
|
)
|
|
(2,260
|
)
|
|||||
Net loss allocable to common stockholders
|
$
|
(107,979
|
)
|
|
$
|
(60,508
|
)
|
|
$
|
(19,435
|
)
|
|
$
|
(88,301
|
)
|
|
$
|
(111,484
|
)
|
Net loss per share allocable to common stockholders, basic and diluted
|
$
|
(0.45
|
)
|
|
$
|
(0.28
|
)
|
|
$
|
(0.09
|
)
|
|
$
|
(0.45
|
)
|
|
$
|
(0.80
|
)
|
Shares used in calculating net loss per share allocable to common stockholders, basic and diluted
|
240,671,335
|
|
|
219,733,539
|
|
|
218,104,323
|
|
|
196,523,708
|
|
|
139,170,725
|
|
|
As of December 31,
|
||||||||||||||||||
|
2015
|
|
2014
|
|
2013
|
|
2012
|
|
2011
|
||||||||||
|
(In thousands)
|
||||||||||||||||||
Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
||||||||||
Cash and cash equivalents
|
$
|
156,184
|
|
|
$
|
163,209
|
|
|
$
|
221,878
|
|
|
$
|
156,091
|
|
|
$
|
57,632
|
|
Total assets
|
256,792
|
|
|
276,385
|
|
|
339,807
|
|
|
261,206
|
|
|
157,129
|
|
|||||
Total deferred revenues
|
109,042
|
|
|
108,302
|
|
|
139,190
|
|
|
62,735
|
|
|
44,682
|
|
|||||
Total lease financing obligations
|
68,245
|
|
|
70,737
|
|
|
72,794
|
|
|
74,458
|
|
|
75,771
|
|
|||||
Total derivative liabilities
|
0
|
|
|
474
|
|
|
4,892
|
|
|
15,042
|
|
|
1,617
|
|
|||||
Total notes payable
|
0
|
|
|
0
|
|
|
0
|
|
|
0
|
|
|
14,698
|
|
|||||
Accumulated deficit
|
(1,376,220
|
)
|
|
(1,268,241
|
)
|
|
(1,207,733
|
)
|
|
(1,188,298
|
)
|
|
(1,079,751
|
)
|
|||||
Total stockholders’ equity
|
53,542
|
|
|
47,345
|
|
|
91,857
|
|
|
98,639
|
|
|
10,562
|
|
•
|
Advance our proprietary clinical programs:
|
◦
|
APD334 - a modulator of the sphingosine 1-phosphate subtype 1, or S1P
1
, receptor - including our ongoing Phase 2 clinical trial for ulcerative colitis, and potentially exploring additional indications beyond inflammatory bowel disease
|
◦
|
Ralinepag - an agonist of the prostacyclin receptor - including our ongoing Phase 2 clinical trial for pulmonary arterial hypertension, or PAH
|
◦
|
APD371 - an agonist of the cannabinoid-2, or CB
2
, receptor - through our ongoing Phase 1 multiple-ascending dose clinical trial
|
•
|
Pursue strategic collaborations for certain clinical and pre-clinical programs
|
•
|
Discover and develop additional pre-clinical drug candidates
|
•
|
Support Eisai Inc. and Eisai Co., Ltd. (collectively, Eisai) and our other collaborators in their BELVIQ efforts, including their work to:
|
◦
|
Advance the major adverse cardiovascular events, or MACE, diabetes conversion, MACE plus and other endpoints of the ongoing BELVIQ cardiovascular outcomes trial, or CVOT (also known as the CAMELLIA study)
|
◦
|
Obtain regulatory approval (initially in the United States) for BELVIQ XR, a once-daily formulation of BELVIQ
|
◦
|
Obtain regulatory approval in additional territories
|
|
Years ended December 31,
|
|
% change from
2014 to 2015 |
|
% change from
2013 to 2014 |
||||||||||||
Source of revenue
|
2015
|
|
2014
|
|
2013
|
|
|||||||||||
Arena’s portion of Eisai net product sales
|
$
|
14.2
|
|
|
$
|
16.0
|
|
|
$
|
5.7
|
|
|
(10.9
|
)%
|
|
180.3
|
%
|
Amortization of upfront payments from Eisai
|
7.5
|
|
|
7.6
|
|
|
4.0
|
|
|
(1.2
|
)%
|
|
89.1
|
%
|
|||
Arena’s portion of Ildong’s net product sales
|
5.5
|
|
|
0.0
|
|
|
0.0
|
|
|
—
|
%
|
|
—
|
%
|
|||
Toll manufacturing agreements
|
4.3
|
|
|
1.5
|
|
|
2.7
|
|
|
184.1
|
%
|
|
(44.4
|
)%
|
|||
Milestone payment from Ildong
|
3.0
|
|
|
0.0
|
|
|
0.0
|
|
|
—
|
%
|
|
—
|
%
|
|||
Reimbursement of development expenses and patent and trademark expenses from Eisai
|
2.0
|
|
|
10.5
|
|
|
2.4
|
|
|
(81.3
|
)%
|
|
340.2
|
%
|
|||
Other collaborative agreements
|
1.4
|
|
|
0.5
|
|
|
0.2
|
|
|
183.3
|
%
|
|
126.2
|
%
|
|||
Amortization of upfront payment from Ildong
|
0.4
|
|
|
0.4
|
|
|
0.4
|
|
|
—
|
%
|
|
—
|
%
|
|||
Milestone payments from Eisai
|
0.0
|
|
|
0.5
|
|
|
66.0
|
|
|
(100.0
|
)%
|
|
(99.2
|
)%
|
|||
Total revenues
|
$
|
38.3
|
|
|
$
|
37.0
|
|
|
$
|
81.4
|
|
|
3.7
|
%
|
|
(54.6
|
)%
|
|
Years ended December 31,
|
|
% change from
2014 to 2015 |
|
% change from
2013 to 2014 |
||||||||||||
Type of expense
|
2015
|
|
2014
|
|
2013
|
|
|||||||||||
External clinical and preclinical study fees and internal non-commercial manufacturing costs
|
$
|
34.1
|
|
|
$
|
44.6
|
|
|
$
|
16.4
|
|
|
(23.6
|
)%
|
|
172.2
|
%
|
Salary and other personnel costs (excluding non-cash share-based compensation)
|
29.1
|
|
|
30.6
|
|
|
27.7
|
|
|
(4.9
|
)%
|
|
10.2
|
%
|
|||
Facility and equipment costs
|
10.0
|
|
|
10.0
|
|
|
10.0
|
|
|
0.1
|
%
|
|
—
|
%
|
|||
Non-cash share-based compensation
|
7.6
|
|
|
7.1
|
|
|
4.3
|
|
|
6.5
|
%
|
|
64.8
|
%
|
|||
Research supply costs
|
6.2
|
|
|
5.5
|
|
|
5.6
|
|
|
13.7
|
%
|
|
(1.3
|
)%
|
|||
Other
|
1.4
|
|
|
2.5
|
|
|
2.5
|
|
|
(45.3
|
)%
|
|
4.5
|
%
|
|||
Total research and development expenses
|
$
|
88.4
|
|
|
$
|
100.3
|
|
|
$
|
66.5
|
|
|
(11.9
|
)%
|
|
51.0
|
%
|
|
Years ended December 31,
|
|
% change from
2014 to 2015 |
|
% change from
2013 to 2014 |
||||||||||||
Type of expense
|
2015
|
|
2014
|
|
2013
|
|
|||||||||||
Salary and other personnel costs (excluding non-cash share-based compensation)
|
$
|
14.5
|
|
|
$
|
13.0
|
|
|
$
|
11.4
|
|
|
10.9
|
%
|
|
13.9
|
%
|
Legal, accounting and other professional fees
|
8.0
|
|
|
8.4
|
|
|
7.3
|
|
|
(5.3
|
)%
|
|
15.4
|
%
|
|||
Non-cash share-based compensation
|
6.7
|
|
|
6.4
|
|
|
4.7
|
|
|
5.0
|
%
|
|
36.3
|
%
|
|||
Facility and equipment costs
|
5.3
|
|
|
4.2
|
|
|
5.1
|
|
|
25.9
|
%
|
|
(16.5
|
)%
|
|||
Other
|
1.5
|
|
|
2.1
|
|
|
3.2
|
|
|
(27.3
|
)%
|
|
(34.9
|
)%
|
|||
Total general and administrative expenses
|
$
|
36.0
|
|
|
$
|
34.1
|
|
|
$
|
31.7
|
|
|
5.4
|
%
|
|
7.8
|
%
|
•
|
$16.2 million related to lorcaserin and non-commercial manufacturing costs,
|
•
|
$8.7 million related to APD334 and
|
•
|
$5.1 million related to ralinepag.
|
•
|
$35.3 million related to lorcaserin and non-commercial manufacturing costs,
|
•
|
$4.2 million related to APD334 and
|
•
|
$2.8 million related to ralinepag.
|
•
|
the nature and number of trials and studies in a clinical program;
|
•
|
the potential therapeutic indication;
|
•
|
the number of patients who participate in the trials;
|
•
|
the number and location of sites included in the trials;
|
•
|
the rates of patient recruitment, enrollment and withdrawal;
|
•
|
the duration of patient treatment and follow-up;
|
•
|
the costs of manufacturing drug candidates; and
|
•
|
the costs, requirements, timing of, and the ability to secure regulatory approvals.
|
•
|
$35.3 million related to lorcaserin and non-commercial manufacturing costs,
|
•
|
$4.2 million related to APD334 and
|
•
|
$2.8 million related to ralinepag.
|
•
|
$11.7 million related to lorcaserin and non-commercial manufacturing costs,
|
•
|
$1.9 million related to ralinepag,
|
•
|
$1.2 million related to APD334 and
|
•
|
$1.0 million related to APD371.
|
|
Payments due by period
|
||||||||||||||||||
Contractual Obligations
|
Total
|
|
Less than 1
year
|
|
1-3
years
|
|
3-5
years
|
|
More than 5
years
|
||||||||||
Financing obligations
|
$
|
102,105
|
|
|
$
|
8,499
|
|
|
$
|
19,225
|
|
|
$
|
16,307
|
|
|
$
|
58,074
|
|
Purchase obligations
|
2,783
|
|
|
2,782
|
|
|
1
|
|
|
0
|
|
|
0
|
|
|||||
Operating leases
|
12,383
|
|
|
1,053
|
|
|
2,314
|
|
|
2,317
|
|
|
6,699
|
|
|||||
Total
|
$
|
117,271
|
|
|
$
|
12,334
|
|
|
$
|
21,540
|
|
|
$
|
18,624
|
|
|
$
|
64,773
|
|
|
Years ended December 31,
|
|
From Inception
Through
December 31,
2015
|
||||||||||||
|
2015
|
|
2014
|
|
2013
|
|
|||||||||
Net product sales
|
$
|
14,236
|
|
|
$
|
15,983
|
|
|
$
|
5,702
|
|
|
$
|
35,921
|
|
Amortization of upfront payments
|
7,541
|
|
|
7,630
|
|
|
4,035
|
|
|
28,067
|
|
||||
Reimbursement of development expenses
|
1,538
|
|
|
10,037
|
|
|
2,020
|
|
|
16,958
|
|
||||
Milestone payments
|
0
|
|
|
500
|
|
|
66,000
|
|
|
86,500
|
|
||||
Reimbursement of patent and trademark expenses
|
426
|
|
|
444
|
|
|
361
|
|
|
1,318
|
|
||||
Subtotal other Eisai collaborative revenue
|
9,505
|
|
|
18,611
|
|
|
72,416
|
|
|
132,843
|
|
||||
Total
|
$
|
23,741
|
|
|
$
|
34,594
|
|
|
$
|
78,118
|
|
|
$
|
168,764
|
|
|
|
United States
|
|
Rest of
North and South America
|
|
Remaining Territories
|
BELVIQ
-Pre-approval*
|
|
Not Applicable
|
|
General
Eisai: 90%; Arena: 10%
Certain stability work
Eisai: 50%; Arena: 50%
|
|
Up to total of $100.0 million** - Eisai: 50%; Arena: 50%
Thereafter, Eisai: 100%
|
BELVIQ
-
Post-approval*
|
|
General
- Eisai: 90%; Arena 10%
Non-FDA required
portion of CVOT
Up to $80.0 million -
Eisai: 50%; Arena: 50%
Thereafter, Eisai: 100%
Certain pediatric studies
Eisai: 50%; Arena: 50%
|
|
General
Eisai: 90%; Arena: 10%
Certain stability work
Eisai: 50%; Arena: 50%
|
|
Up to total of $50.0 million -
Eisai: 50%; Arena: 50%
Thereafter, Eisai: 90%; Arena: 10%
|
Lorcaserin products other than BELVIQ
-Pre-approva
l
|
|
Up to a total of $250.0 million (as reduced by up to $80.0 million for non-FDA required portion of CVOT)**
- Eisai: 50%; Arena: 50%
|
||||
Lorcaserin
products other than BELVIQ
-Post-approval
|
|
Up to a total of $100.0 million in the aggregate across all additional products -
Eisai: 50%; Arena: 50%
Thereafter, Eisai: 90%; Arena: 10%
|
*
|
Development required by a regulatory authority, with the exception of the non-FDA required portion of the CVOT.
|
**
|
Under the collaborative agreement, the amount for BELVIQ pre-approval in the Remaining Territories was decreased and the amount for lorcaserin products other than BELVIQ pre-approval was increased by such amount.
|
|
/s/ KPMG LLP
|
|
December 31,
|
||||||
|
2015
|
|
2014
|
||||
Assets
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
156,184
|
|
|
$
|
163,209
|
|
Accounts receivable
|
4,934
|
|
|
3,712
|
|
||
Inventory
|
9,502
|
|
|
10,831
|
|
||
Prepaid expenses and other current assets
|
4,218
|
|
|
4,144
|
|
||
Total current assets
|
174,838
|
|
|
181,896
|
|
||
Land, property and equipment, net
|
71,828
|
|
|
82,919
|
|
||
Intangibles, net
|
7,775
|
|
|
8,482
|
|
||
Other non-current assets
|
2,351
|
|
|
3,088
|
|
||
Total assets
|
$
|
256,792
|
|
|
$
|
276,385
|
|
Liabilities and Stockholders’ Equity
|
|
|
|
||||
Current liabilities:
|
|
|
|
||||
Accounts payable and other accrued liabilities
|
$
|
10,127
|
|
|
$
|
10,209
|
|
Accrued clinical and preclinical study fees
|
3,286
|
|
|
7,027
|
|
||
Payable to Eisai
|
12,080
|
|
|
23,705
|
|
||
Current portion of deferred revenues
|
21,425
|
|
|
15,238
|
|
||
Current portion of lease financing obligations
|
2,978
|
|
|
2,492
|
|
||
Payable to Siegfried for acquisition of land and building
|
0
|
|
|
8,217
|
|
||
Derivative liabilities
|
0
|
|
|
474
|
|
||
Total current liabilities
|
49,896
|
|
|
67,362
|
|
||
Deferred rent
|
470
|
|
|
369
|
|
||
Deferred revenues, less current portion
|
87,617
|
|
|
93,064
|
|
||
Lease financing obligations, less current portion
|
65,267
|
|
|
68,245
|
|
||
Commitments and contingencies
|
|
|
|
||||
Stockholders’ equity:
|
|
|
|
||||
Preferred stock, $0.0001 par value: 7,500,000 shares authorized and 0 shares issued and outstanding at December 31, 2015, and 2014
|
0
|
|
|
0
|
|
||
Common stock, $0.0001 par value: 367,500,000 shares authorized at December 31, 2015, and 2014; 242,871,179 shares issued and outstanding at December 31, 2015; 220,321,645 shares issued and outstanding at December 31, 2014
|
24
|
|
|
22
|
|
||
Additional paid-in capital
|
1,430,917
|
|
|
1,312,656
|
|
||
Accumulated other comprehensive income (loss)
|
(1,179
|
)
|
|
2,908
|
|
||
Accumulated deficit
|
(1,376,220
|
)
|
|
(1,268,241
|
)
|
||
Total stockholders’ equity
|
53,542
|
|
|
47,345
|
|
||
Total liabilities and stockholders’ equity
|
$
|
256,792
|
|
|
$
|
276,385
|
|
|
Years ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Revenues:
|
|
|
|
|
|
||||||
Net product sales
|
$
|
19,726
|
|
|
$
|
15,983
|
|
|
$
|
5,702
|
|
Other Eisai collaborative revenue
|
9,505
|
|
|
18,611
|
|
|
72,416
|
|
|||
Toll manufacturing
|
4,250
|
|
|
1,497
|
|
|
2,690
|
|
|||
Other collaborative revenue
|
4,845
|
|
|
879
|
|
|
586
|
|
|||
Total revenues
|
38,326
|
|
|
36,970
|
|
|
81,394
|
|
|||
Operating Costs and Expenses:
|
|
|
|
|
|
||||||
Cost of product sales
|
8,590
|
|
|
6,369
|
|
|
1,803
|
|
|||
Cost of toll manufacturing
|
4,585
|
|
|
1,390
|
|
|
4,377
|
|
|||
Research and development
|
88,411
|
|
|
100,347
|
|
|
66,468
|
|
|||
General and administrative
|
35,966
|
|
|
34,137
|
|
|
31,681
|
|
|||
Restructuring charges
|
3,972
|
|
|
0
|
|
|
0
|
|
|||
Total operating costs and expenses
|
141,524
|
|
|
142,243
|
|
|
104,329
|
|
|||
Loss from operations
|
(103,198
|
)
|
|
(105,273
|
)
|
|
(22,935
|
)
|
|||
Interest and Other Income (Expense):
|
|
|
|
|
|
||||||
Interest income
|
158
|
|
|
83
|
|
|
89
|
|
|||
Interest expense
|
(6,828
|
)
|
|
(6,915
|
)
|
|
(7,091
|
)
|
|||
Gain from valuation of derivative liabilities
|
474
|
|
|
4,418
|
|
|
10,150
|
|
|||
Gain on sale of available-for-sale securities
|
0
|
|
|
49,553
|
|
|
0
|
|
|||
Other
|
1,415
|
|
|
(2,374
|
)
|
|
352
|
|
|||
Total interest and other income (expense), net
|
(4,781
|
)
|
|
44,765
|
|
|
3,500
|
|
|||
Net loss
|
$
|
(107,979
|
)
|
|
$
|
(60,508
|
)
|
|
$
|
(19,435
|
)
|
Net loss per share:
|
|
|
|
|
|
||||||
Basic
|
$
|
(0.45
|
)
|
|
$
|
(0.28
|
)
|
|
$
|
(0.09
|
)
|
Diluted
|
$
|
(0.45
|
)
|
|
$
|
(0.28
|
)
|
|
$
|
(0.09
|
)
|
Shares used in calculating net loss per share:
|
|
|
|
|
|
||||||
Basic
|
240,671,335
|
|
|
219,733,539
|
|
|
218,104,323
|
|
|||
Diluted
|
240,671,335
|
|
|
219,733,539
|
|
|
218,104,323
|
|
|||
Comprehensive Loss:
|
|
|
|
|
|
||||||
Net loss
|
$
|
(107,979
|
)
|
|
$
|
(60,508
|
)
|
|
$
|
(19,435
|
)
|
Foreign currency translation gain (loss)
|
(4,087
|
)
|
|
(2,820
|
)
|
|
239
|
|
|||
Comprehensive loss
|
$
|
(112,066
|
)
|
|
$
|
(63,328
|
)
|
|
$
|
(19,196
|
)
|
|
Common Stock
|
|
Additional
Paid-In
Capital
|
|
Accumulated
Other
Comprehensive
Income (Loss)
|
|
Accumulated
Deficit
|
|
Total
Stockholders’
Equity
|
|||||||||||||
|
Shares
|
|
Amount
|
|
||||||||||||||||||
Balance at December 31, 2012
|
217,476,458
|
|
|
$
|
22
|
|
|
$
|
1,281,426
|
|
|
$
|
5,489
|
|
|
$
|
(1,188,298
|
)
|
|
$
|
98,639
|
|
Issuance of common stock upon exercise of options
|
954,174
|
|
|
|
|
2,375
|
|
|
|
|
|
|
2,375
|
|
||||||||
Issuance of common stock under employee stock purchase plan
|
334,360
|
|
|
|
|
852
|
|
|
|
|
|
|
852
|
|
||||||||
Issuance of common stock upon vesting of restricted stock unit awards
|
41,250
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Issuance of common stock upon exercise of Series B warrant
|
10,000
|
|
|
|
|
88
|
|
|
|
|
|
|
88
|
|
||||||||
Share-based compensation expense, net of forfeitures
|
|
|
|
|
9,024
|
|
|
|
|
|
|
9,024
|
|
|||||||||
Share-based compensation expense capitalized
|
|
|
|
|
75
|
|
|
|
|
|
|
75
|
|
|||||||||
Translation gain
|
|
|
|
|
|
|
239
|
|
|
|
|
239
|
|
|||||||||
Net loss
|
|
|
|
|
|
|
|
|
(19,435
|
)
|
|
(19,435
|
)
|
|||||||||
Balance at December 31, 2013
|
218,816,242
|
|
|
22
|
|
|
1,293,840
|
|
|
5,728
|
|
|
(1,207,733
|
)
|
|
91,857
|
|
|||||
Issuance of common stock upon exercise of options
|
1,115,068
|
|
|
|
|
4,078
|
|
|
|
|
|
|
4,078
|
|
||||||||
Issuance of common stock under employee stock purchase plan
|
304,085
|
|
|
|
|
1,148
|
|
|
|
|
|
|
1,148
|
|
||||||||
Issuance of common stock upon vesting of restricted stock unit awards
|
86,250
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Share-based compensation expense, net of forfeitures
|
|
|
|
|
13,509
|
|
|
|
|
|
|
13,509
|
|
|||||||||
Share-based compensation expense capitalized
|
|
|
|
|
81
|
|
|
|
|
|
|
81
|
|
|||||||||
Translation loss
|
|
|
|
|
|
|
(2,820
|
)
|
|
|
|
(2,820
|
)
|
|||||||||
Net loss
|
|
|
|
|
|
|
|
|
(60,508
|
)
|
|
(60,508
|
)
|
|||||||||
Balance at December 31, 2014
|
220,321,645
|
|
|
22
|
|
|
1,312,656
|
|
|
2,908
|
|
|
(1,268,241
|
)
|
|
47,345
|
|
|||||
Issuance of common stock to underwriters
|
21,000,000
|
|
|
2
|
|
|
100,656
|
|
|
|
|
|
|
100,658
|
|
|||||||
Issuance of common stock upon exercise of options
|
1,154,084
|
|
|
|
|
2,211
|
|
|
|
|
|
|
2,211
|
|
||||||||
Issuance of common stock under employee stock purchase plan
|
327,950
|
|
|
|
|
758
|
|
|
|
|
|
|
758
|
|
||||||||
Issuance of common stock upon vesting of restricted stock unit awards
|
67,500
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Share-based compensation expense, net of forfeitures
|
|
|
|
|
14,463
|
|
|
|
|
|
|
14,463
|
|
|||||||||
Share-based compensation expense capitalized
|
|
|
|
|
173
|
|
|
|
|
|
|
173
|
|
|||||||||
Translation loss
|
|
|
|
|
|
|
(4,087
|
)
|
|
|
|
(4,087
|
)
|
|||||||||
Net loss
|
|
|
|
|
|
|
|
|
(107,979
|
)
|
|
(107,979
|
)
|
|||||||||
Balance at December 31, 2015
|
242,871,179
|
|
|
$
|
24
|
|
|
$
|
1,430,917
|
|
|
$
|
(1,179
|
)
|
|
$
|
(1,376,220
|
)
|
|
$
|
53,542
|
|
|
Years ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Operating Activities
|
|
|
|
|
|
||||||
Net loss
|
$
|
(107,979
|
)
|
|
$
|
(60,508
|
)
|
|
$
|
(19,435
|
)
|
Adjustments to reconcile net loss to net cash provided by (used in) operating activities:
|
|
|
|
|
|
||||||
Depreciation and amortization
|
9,804
|
|
|
8,655
|
|
|
7,733
|
|
|||
Amortization of intangibles
|
238
|
|
|
506
|
|
|
469
|
|
|||
Share-based compensation
|
14,463
|
|
|
13,509
|
|
|
9,024
|
|
|||
Gain from valuation of derivative liabilities
|
(474
|
)
|
|
(4,418
|
)
|
|
(10,150
|
)
|
|||
Gain on sale of available-for-sale securities
|
0
|
|
|
(49,553
|
)
|
|
0
|
|
|||
Amortization of prepaid financing costs
|
136
|
|
|
136
|
|
|
136
|
|
|||
Loss on disposal or sale of equipment
|
1,007
|
|
|
172
|
|
|
49
|
|
|||
Changes in assets and liabilities:
|
|
|
|
|
|
||||||
Accounts receivable
|
(1,425
|
)
|
|
6,407
|
|
|
(4,473
|
)
|
|||
Inventory
|
1,858
|
|
|
870
|
|
|
(6,065
|
)
|
|||
Prepaid expenses and other assets
|
575
|
|
|
(772
|
)
|
|
(65
|
)
|
|||
Payables and accrued liabilities
|
(16,970
|
)
|
|
13,240
|
|
|
19,572
|
|
|||
Deferred revenues
|
553
|
|
|
(29,764
|
)
|
|
75,880
|
|
|||
Deferred rent
|
101
|
|
|
122
|
|
|
125
|
|
|||
Net cash provided by (used in) operating activities
|
(98,113
|
)
|
|
(101,398
|
)
|
|
72,800
|
|
|||
Investing Activities
|
|
|
|
|
|
||||||
Proceeds from sale of available-for-sale securities
|
0
|
|
|
49,553
|
|
|
0
|
|
|||
Purchases of land, property and equipment
|
(10,992
|
)
|
|
(8,905
|
)
|
|
(9,164
|
)
|
|||
Proceeds from sale of equipment
|
2,232
|
|
|
47
|
|
|
60
|
|
|||
Other non-current assets
|
609
|
|
|
209
|
|
|
439
|
|
|||
Net cash provided by (used in) investing activities
|
(8,151
|
)
|
|
40,904
|
|
|
(8,665
|
)
|
|||
Financing Activities
|
|
|
|
|
|
||||||
Principal payments on lease financing obligations
|
(2,492
|
)
|
|
(2,057
|
)
|
|
(1,664
|
)
|
|||
Proceeds from issuance of common stock
|
103,628
|
|
|
5,225
|
|
|
3,315
|
|
|||
Net cash provided by financing activities
|
101,136
|
|
|
3,168
|
|
|
1,651
|
|
|||
Effect of exchange rate changes on cash
|
(1,897
|
)
|
|
(1,343
|
)
|
|
1
|
|
|||
Net increase (decrease) in cash and cash equivalents
|
(7,025
|
)
|
|
(58,669
|
)
|
|
65,787
|
|
|||
Cash and cash equivalents at beginning of year
|
163,209
|
|
|
221,878
|
|
|
156,091
|
|
|||
Cash and cash equivalents at end of year
|
$
|
156,184
|
|
|
$
|
163,209
|
|
|
$
|
221,878
|
|
|
|
|
|
|
|
||||||
Supplemental Disclosure Of Cash Flow Information:
|
|
|
|
|
|
||||||
Interest paid
|
$
|
6,562
|
|
|
$
|
6,778
|
|
|
$
|
6,954
|
|
|
|
|
|
|
|
||||||
Supplemental Disclosure Of Non-Cash Investing and Financing Information:
|
|
|
|
|
|
||||||
Payable to Siegfried for acquisition of land and building
|
$
|
0
|
|
|
$
|
8,217
|
|
|
$
|
0
|
|
|
Years ended December 31,
|
|||||||
|
2015
|
|
2014
|
|
2013
|
|||
Eisai Agreement (See Note 12)
|
61.9
|
%
|
|
93.6
|
%
|
|
96.0
|
%
|
Ildong Agreement (See Note 12)
|
23.2
|
%
|
|
1.0
|
%
|
|
0.6
|
%
|
Toll manufacturing agreements
|
11.1
|
%
|
|
4.0
|
%
|
|
3.3
|
%
|
Other collaborative agreements
|
3.8
|
%
|
|
1.4
|
%
|
|
0.1
|
%
|
Total percentage of revenues
|
100.0
|
%
|
|
100.0
|
%
|
|
100.0
|
%
|
|
Years ended December 31,
|
|||||||
|
2015
|
|
2014
|
|
2013
|
|||
Stock options
|
17,030
|
|
|
15,530
|
|
|
14,435
|
|
Warrants
|
19
|
|
|
370
|
|
|
776
|
|
RSUs and unvested restricted stock
|
547
|
|
|
476
|
|
|
306
|
|
Total
|
17,596
|
|
|
16,376
|
|
|
15,517
|
|
Level 1
|
|
-
|
|
Observable inputs such as unadjusted quoted prices in active markets for identical instruments.
|
|
|
|
|
|
Level 2
|
|
-
|
|
Quoted prices for similar instruments in active markets or inputs that are observable for the asset or liability, either directly or indirectly.
|
|
|
|
|
|
Level 3
|
|
-
|
|
Significant unobservable inputs based on our assumptions.
|
|
Fair Value Measurements at December 31, 2015
|
||||||||||||||
|
Balance
|
|
Quoted Prices in
Active Markets
(Level 1)
|
|
Significant Other
Observable
Inputs
(Level 2)
|
|
Significant
Unobservable Inputs
(Level 3)
|
||||||||
Assets:
|
|
|
|
|
|
|
|
||||||||
Money market funds
1
|
$
|
113,080
|
|
|
$
|
113,080
|
|
|
$
|
0
|
|
|
$
|
0
|
|
|
|
|
|
|
|
|
|
||||||||
|
Fair Value Measurements at December 31, 2014
|
||||||||||||||
|
Balance
|
|
Quoted Prices in
Active Markets
(Level 1)
|
|
Significant Other
Observable
Inputs
(Level 2)
|
|
Significant
Unobservable Inputs
(Level 3)
|
||||||||
Assets:
|
|
|
|
|
|
|
|
||||||||
Money market funds
1
|
$
|
143,913
|
|
|
$
|
143,913
|
|
|
$
|
0
|
|
|
$
|
0
|
|
Liabilities:
|
|
|
|
|
|
|
|
||||||||
Warrant derivative liabilities
2
|
$
|
474
|
|
|
$
|
0
|
|
|
$
|
474
|
|
|
$
|
0
|
|
|
|
December 31,
|
||||||
|
2015
|
|
2014
|
||||
Raw materials
|
$
|
2,487
|
|
|
$
|
1,167
|
|
Work in process
|
2,781
|
|
|
3,520
|
|
||
Finished goods at Arena GmbH
|
165
|
|
|
3,681
|
|
||
Finished goods at Eisai
|
3,309
|
|
|
2,463
|
|
||
Finished goods at Ildong
|
760
|
|
|
0
|
|
||
Total inventory
|
$
|
9,502
|
|
|
$
|
10,831
|
|
|
December 31,
|
||||||
|
2015
|
|
2014
|
||||
Land
|
$
|
8,131
|
|
|
$
|
11,339
|
|
Building and capital improvements
|
74,663
|
|
|
74,629
|
|
||
Leasehold improvements
|
18,025
|
|
|
17,984
|
|
||
Machinery and equipment
|
53,790
|
|
|
53,247
|
|
||
Computers and software
|
15,893
|
|
|
15,363
|
|
||
Furniture and office equipment
|
2,227
|
|
|
2,376
|
|
||
|
172,729
|
|
|
174,938
|
|
||
Less accumulated depreciation and amortization
|
(100,901
|
)
|
|
(92,019
|
)
|
||
Land, property and equipment, net
|
$
|
71,828
|
|
|
$
|
82,919
|
|
|
December 31,
|
||||||
|
2015
|
|
2014
|
||||
Acquired manufacturing production licenses – gross
|
$
|
12,958
|
|
|
$
|
13,049
|
|
Acquired manufacturing production licenses – accumulated amortization
|
(5,183
|
)
|
|
(4,567
|
)
|
||
Intangibles, net
|
$
|
7,775
|
|
|
$
|
8,482
|
|
|
December 31,
|
||||||
|
2015
|
|
2014
|
||||
Accounts payable
|
$
|
2,078
|
|
|
$
|
2,844
|
|
Accrued compensation
|
5,118
|
|
|
4,792
|
|
||
Accrued workforce reduction expenses
|
1,793
|
|
|
0
|
|
||
Other accrued liabilities
|
1,138
|
|
|
2,573
|
|
||
Total accounts payable and other accrued liabilities
|
$
|
10,127
|
|
|
$
|
10,209
|
|
Year ending December 31,
|
|
Financing
Obligations
|
|
Operating
Leases
|
||||
2016
|
|
$
|
8,499
|
|
|
$
|
1,053
|
|
2017
|
|
9,494
|
|
|
1,146
|
|
||
2018
|
|
9,731
|
|
|
1,168
|
|
||
2019
|
|
8,053
|
|
|
1,191
|
|
||
2020
|
|
8,254
|
|
|
1,126
|
|
||
Thereafter
|
|
58,074
|
|
|
6,699
|
|
||
Total minimum lease payments
|
|
102,105
|
|
|
$
|
12,383
|
|
|
Less amounts representing interest
|
|
(43,850
|
)
|
|
|
|||
Add amounts representing residual value
|
|
9,990
|
|
|
|
|||
Lease financing obligations
|
|
68,245
|
|
|
|
|||
Less current portion
|
|
(2,978
|
)
|
|
|
|||
|
|
$
|
65,267
|
|
|
|
|
Options
|
|
Weighted-
Average
Exercise Price
|
|
Weighted-Average
Remaining
Contractual
Term (in years)
|
|
Aggregate
Intrinsic
Value
|
|||||
Outstanding at December 31, 2014
|
15,831
|
|
|
$
|
5.25
|
|
|
|
|
|
||
Granted
|
4,322
|
|
|
$
|
3.69
|
|
|
|
|
|
||
Exercised
|
(1,154
|
)
|
|
$
|
1.92
|
|
|
|
|
|
||
Forfeited/cancelled/expired
|
(2,592
|
)
|
|
$
|
5.64
|
|
|
|
|
|
||
Outstanding at December 31, 2015
|
16,407
|
|
|
$
|
5.01
|
|
|
4.44
|
|
$
|
1,090
|
|
Vested and expected to vest at December 31, 2015
|
15,835
|
|
|
$
|
5.04
|
|
|
4.37
|
|
$
|
1,071
|
|
Vested and exercisable at December 31, 2015
|
10,206
|
|
|
$
|
5.37
|
|
|
3.53
|
|
$
|
906
|
|
|
RSUs
|
|
Weighted-Average
Grant-Date Fair
Value
|
|
Aggregate
Intrinsic
Value
|
|||||
Unvested at December 31, 2014
|
456
|
|
|
$
|
5.72
|
|
|
|
||
Granted
|
281
|
|
|
$
|
4.11
|
|
|
|
||
Vested
|
(384
|
)
|
|
$
|
5.47
|
|
|
|
||
Forfeited/cancelled
|
(80
|
)
|
|
$
|
4.88
|
|
|
|
||
Unvested at December 31, 2015
|
273
|
|
|
$
|
4.67
|
|
|
|
||
Outstanding at December 31, 2015
|
810
|
|
|
$
|
5.80
|
|
|
$
|
4,698
|
|
|
Years ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Risk-free interest rate
|
1.8
|
%
|
|
1.8
|
%
|
|
1.3
|
%
|
|||
Dividend yield
|
0
|
%
|
|
0
|
%
|
|
0
|
%
|
|||
Expected volatility
|
80
|
%
|
|
81
|
%
|
|
80
|
%
|
|||
Expected life (years)
|
P6Y1M2D
|
|
|
6.17
|
|
|
6.24
|
|
|||
Weighted-average estimated fair value per share of stock options granted
|
$
|
2.55
|
|
|
$
|
4.37
|
|
|
$
|
5.25
|
|
|
Years ended December 31,
|
||||
|
2015
|
|
2014
|
|
2013
|
Risk-free interest rate
|
0.0% - 1.0%
|
|
0.0% - 0.6%
|
|
0.0% - 0.5%
|
Dividend yield
|
0%
|
|
0%
|
|
0%
|
Expected volatility
|
52% - 78%
|
|
53% - 81%
|
|
79% - 105%
|
Expected life (years)
|
.25 - 2.0
|
|
.25 - 2.0
|
|
.25 - 2.0
|
Range of fair value per share of options granted under employee stock purchase plan
|
$0.78 to $2.94
|
|
$1.37 to $4.22
|
|
$0.90 to $5.44
|
|
Years ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Risk-free interest rate
|
1.1
|
%
|
|
0.7
|
%
|
|
0.4
|
%
|
|||
Dividend yield
|
0
|
%
|
|
0
|
%
|
|
0
|
%
|
|||
Expected volatility
|
75
|
%
|
|
78
|
%
|
|
89
|
%
|
|||
Performance period (years)
|
2.97
|
|
|
2.99
|
|
|
2.99
|
|
|||
Estimated fair value per share of PRSUs granted
|
$
|
4.50
|
|
|
$
|
7.16
|
|
|
$
|
7.50
|
|
|
Years ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Cost of product sales
|
$
|
29
|
|
|
$
|
0
|
|
|
$
|
17
|
|
Research and development
|
7,582
|
|
|
7,118
|
|
|
4,318
|
|
|||
General and administrative
|
6,710
|
|
|
6,391
|
|
|
4,689
|
|
|||
Restructuring charges
|
142
|
|
|
0
|
|
|
0
|
|
|||
Total share-based compensation expense and impact on net loss
|
$
|
14,463
|
|
|
$
|
13,509
|
|
|
$
|
9,024
|
|
Impact on net loss per share, basic and diluted
|
$
|
0.06
|
|
|
$
|
0.06
|
|
|
$
|
0.04
|
|
Total share-based compensation capitalized into inventory
|
$
|
173
|
|
|
$
|
81
|
|
|
$
|
75
|
|
|
Unrecognized
Expense (in
thousands)
|
|
Remaining
Weighted-Average
Recognition
Period (in years)
|
||
Unvested stock options
|
$
|
12,660
|
|
|
2.47
|
RSUs
|
1,199
|
|
|
1.32
|
|
PRSUs
|
2,735
|
|
|
1.04
|
Equity Compensation Plans
|
40,537
|
|
2009 ESPP
|
1,257
|
|
Deferred compensation plan
|
79
|
|
Total
|
41,873
|
|
|
Years ended December 31,
|
|
From Inception
Through
December 31,
2015
|
||||||||||||
|
2015
|
|
2014
|
|
2013
|
|
|||||||||
Net product sales
|
$
|
14,236
|
|
|
$
|
15,983
|
|
|
$
|
5,702
|
|
|
$
|
35,921
|
|
Amortization of upfront payments
|
7,541
|
|
|
7,630
|
|
|
4,035
|
|
|
28,067
|
|
||||
Reimbursement of development expenses
|
1,538
|
|
|
10,037
|
|
|
2,020
|
|
|
16,958
|
|
||||
Milestone payments
|
0
|
|
|
500
|
|
|
66,000
|
|
|
86,500
|
|
||||
Reimbursement of patent and trademark expenses
|
426
|
|
|
444
|
|
|
361
|
|
|
1,318
|
|
||||
Subtotal other Eisai collaborative revenue
|
9,505
|
|
|
18,611
|
|
|
72,416
|
|
|
132,843
|
|
||||
Total
|
$
|
23,741
|
|
|
$
|
34,594
|
|
|
$
|
78,118
|
|
|
$
|
168,764
|
|
|
December 31,
|
||||||
|
2015
|
|
2014
|
||||
Upfront payments
|
$
|
86,933
|
|
|
$
|
94,474
|
|
Net product sales
|
10,754
|
|
|
7,081
|
|
||
Total deferred revenues attributable to Eisai
|
97,687
|
|
|
101,555
|
|
||
Less current portion
|
(18,295
|
)
|
|
(14,622
|
)
|
||
Deferred revenues attributable to Eisai, less current portion
|
$
|
79,392
|
|
|
$
|
86,933
|
|
|
|
United States
|
|
Rest of
North and South America
|
|
Remaining Territories
|
|
|
|
|
|
|
|
BELVIQ
- Pre-approval*
|
|
Not Applicable
|
|
General
Eisai: 90%; Arena: 10%
Certain stability work
Eisai: 50%; Arena: 50%
|
|
Up to total of $100.0 million**
Eisai: 50%; Arena: 50%
Thereafter, Eisai: 100%
|
|
|
|
|
|
|
|
BELVIQ
- Post-approval*
|
|
General
Eisai: 90%; Arena 10%
Non-FDA required portion of CVOT
Up to $80.0 million -
Eisai: 50%; Arena: 50%
Thereafter, Eisai: 100%
Certain pediatric studies
Eisai: 50%; Arena: 50%
|
|
General
Eisai: 90%; Arena: 10%
Certain stability work
Eisai: 50%; Arena: 50%
|
|
Up to total of $50.0 million -
Eisai: 50%; Arena: 50%
Thereafter, Eisai: 90%;
Arena: 10%
|
|
|
|
|
|
|
|
Lorcaserin
products other than
BELVIQ
- Pre-approval
|
|
Up to a total of $250.0 million (as reduced by up to $80.0 million for non-FDA required portion of CVOT)**
- Eisai: 50%; Arena: 50%
|
||||
|
|
|
||||
Lorcaserin
products other than
BELVIQ
- Post-approval
|
|
Up to a total of $100.0 million in the aggregate across all additional products -
Eisai: 50%; Arena: 50%
Thereafter, Eisai: 90%; Arena: 10%
|
*
|
Development required by a regulatory authority, with the exception of the non-FDA required portion of the CVOT.
|
**
|
Under the collaborative agreement, the amount for BELVIQ pre-approval in the Remaining Territories was decreased and the amount for lorcaserin products other than BELVIQ pre-approval was increased by such amount.
|
|
Years ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
United States
|
$
|
(64,109
|
)
|
|
$
|
(16,607
|
)
|
|
$
|
11,573
|
|
Foreign
|
(43,870
|
)
|
|
(43,901
|
)
|
|
(31,008
|
)
|
|||
Total loss before income taxes
|
$
|
(107,979
|
)
|
|
$
|
(60,508
|
)
|
|
$
|
(19,435
|
)
|
|
Years ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Benefit for income taxes at statutory Federal rate
|
$
|
(36,713
|
)
|
|
$
|
(20,573
|
)
|
|
$
|
(6,608
|
)
|
State income tax, net of Federal benefit and valuation allowance
|
0
|
|
|
0
|
|
|
0
|
|
|||
Permanent differences and other
|
4,190
|
|
|
2,318
|
|
|
2,122
|
|
|||
Gain from valuation of derivative liabilities
|
(162
|
)
|
|
(1,507
|
)
|
|
(3,922
|
)
|
|||
Foreign losses at lower effective rates
|
15,041
|
|
|
13,318
|
|
|
9,527
|
|
|||
Research and development and Orphan Drug credits
|
(3,666
|
)
|
|
(2,992
|
)
|
|
(2,594
|
)
|
|||
Adjustment to research and development credits and net operating losses, or NOLs
|
0
|
|
|
0
|
|
|
(59,790
|
)
|
|||
Change in Federal and foreign valuation allowance
|
21,310
|
|
|
9,436
|
|
|
61,265
|
|
|||
Benefit for income taxes
|
$
|
0
|
|
|
$
|
0
|
|
|
$
|
0
|
|
|
December 31,
|
||||||
|
2015
|
|
2014
|
||||
Deferred tax assets:
|
|
|
|
||||
Foreign NOL carryforwards
|
$
|
7,060
|
|
|
$
|
9,518
|
|
Federal and California NOL carryforwards
|
236,334
|
|
|
216,906
|
|
||
Federal and California research and development credit carryforwards
|
48,768
|
|
|
44,022
|
|
||
Deferred revenues
|
33,548
|
|
|
36,448
|
|
||
Depreciation
|
4,475
|
|
|
3,714
|
|
||
Share-based compensation expense
|
10,737
|
|
|
8,549
|
|
||
Other, net
|
3,578
|
|
|
4,011
|
|
||
Total deferred tax assets
|
344,500
|
|
|
323,168
|
|
||
Deferred tax liabilities
|
(660
|
)
|
|
(767
|
)
|
||
Net deferred tax assets
|
343,840
|
|
|
322,401
|
|
||
Valuation allowance
|
(343,840
|
)
|
|
(322,401
|
)
|
||
Net deferred tax liabilities
|
$
|
0
|
|
|
$
|
0
|
|
|
Years ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Gross unrecognized tax benefits at the beginning of the year
|
$
|
5,214
|
|
|
$
|
4,629
|
|
|
$
|
0
|
|
Additions from tax positions taken in the current year
|
405
|
|
|
585
|
|
|
541
|
|
|||
Additions from tax positions taken in prior years
|
0
|
|
|
0
|
|
|
4,088
|
|
|||
Reductions from tax positions taken in prior years
|
0
|
|
|
0
|
|
|
0
|
|
|||
Tax settlements
|
0
|
|
|
0
|
|
|
0
|
|
|||
Gross unrecognized tax benefits at end of the year
|
$
|
5,619
|
|
|
$
|
5,214
|
|
|
$
|
4,629
|
|
2015
|
Quarter ended
December 31
|
|
Quarter ended
September 30
|
|
Quarter ended
June 30
|
|
Quarter ended
March 31
|
|
Year ended
December 31
|
||||||||||
Revenues
|
$
|
7,751
|
|
|
$
|
9,138
|
|
|
$
|
9,181
|
|
|
$
|
12,256
|
|
|
$
|
38,326
|
|
Operating costs and expenses
|
$
|
37,045
|
|
|
$
|
34,319
|
|
|
$
|
36,160
|
|
|
$
|
34,000
|
|
|
$
|
141,524
|
|
Net loss
|
$
|
(30,459
|
)
|
|
$
|
(26,418
|
)
|
|
$
|
(26,807
|
)
|
|
$
|
(24,295
|
)
|
|
$
|
(107,979
|
)
|
Net loss per share, basic and diluted
|
$
|
(0.13
|
)
|
|
$
|
(0.11
|
)
|
|
$
|
(0.11
|
)
|
|
$
|
(0.10
|
)
|
|
$
|
(0.45
|
)
|
2014
|
Quarter ended
December 31
|
|
Quarter ended
September 30
|
|
Quarter ended
June 30
|
|
Quarter ended
March 31
|
|
Year ended
December 31
|
||||||||||
Revenues
|
$
|
9,191
|
|
|
$
|
8,164
|
|
|
$
|
12,801
|
|
|
$
|
6,814
|
|
|
$
|
36,970
|
|
Operating costs and expenses
|
$
|
39,351
|
|
|
$
|
34,373
|
|
|
$
|
38,167
|
|
|
$
|
30,352
|
|
|
$
|
142,243
|
|
Net loss
|
$
|
(32,061
|
)
|
|
$
|
(10,672
|
)
|
|
$
|
7,480
|
|
|
$
|
(25,255
|
)
|
|
$
|
(60,508
|
)
|
Net loss per share, basic and diluted
|
$
|
(0.15
|
)
|
|
$
|
(0.05
|
)
|
|
$
|
0.03
|
|
|
$
|
(0.12
|
)
|
|
$
|
(0.28
|
)
|
|
/s/ KPMG LLP
|
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 security holders
|
21,568,423*
|
|
|
$
|
3.81
|
|
|
20,225,065**
|
|
Equity compensation plans not approved by security holders
|
0
|
|
|
|
|
0
|
|
||
Total
|
21,568,423*
|
|
|
$
|
3.81
|
|
|
20,225,065**
|
|
|
*
|
Includes stock options to purchase
16,406,714
shares of our common stock with a per share weighted-average exercise price of
$5.01
. Also includes (i)
1,009,624
restricted stock unit awards with no exercise price and (ii)
2,076,043
performance restricted stock unit awards with no exercise price. In the aggregate, the target number of shares of common stock that may be earned under the performance restricted stock unit awards is
4,152,085
; however, the actual number of shares that may be earned ranges from 0% to 200% of such amount, and this table reflects 200%.
|
**
|
Includes
1,256,585
shares of common stock available for future issuance under our 2009 Employee Stock Purchase Plan, as amended. Stock options and stock appreciation rights granted under our 2013 Long-Term Incentive Plan, or 2013 LTIP, reduce the available number of shares under our 2013 LTIP by 1 share for every share issued while awards other than stock options and stock appreciation rights granted under our 2013 LTIP reduce the available number of shares by 1.25 shares for every share issued. In addition, shares that are released from awards granted under any of our prior long-term incentive plans or the 2013 LTIP because the awards expire, are forfeited or are settled for cash will increase the number of shares available under our 2013 LTIP by 1 share for each share released from a stock option or stock appreciation right and by 1.25 shares for each share released from a restricted stock award or restricted stock unit award. Each share we withhold to satisfy any tax withholding obligation with respect to an award other than an option or stock appreciation right under any of our prior long-term incentive plans or the 2013 LTIP will increase the share reserve by 1.25 shares.
|
(a)
|
1.
FINANCIAL STATEMENTS.
|
EXHIBIT
NO.
|
|
DESCRIPTION
|
|
|
|
2.1*
|
|
Agreement of Purchase and Sale, dated as of March 21, 2007, by and between Arena and BMR-6114-6154 Nancy Ridge Drive LLP (as assignee of BioMed Realty, L.P.) (incorporated by reference to Exhibit 2.1 to Arena’s current report on Form 8-K filed with the Securities and Exchange Commission on May 8, 2007, Commission File No. 000-31161)
|
|
|
|
3.1
|
|
Fifth Amended and Restated Certificate of Incorporation of Arena (incorporated by reference to Exhibit 3.1 to Arena’s quarterly report on Form 10-Q for the quarter ended June 30, 2002, filed with the Securities and Exchange Commission on August 14, 2002, Commission File No. 000-31161)
|
|
|
|
3.2
|
|
Certificate of Amendment of the Fifth Amended and Restated Certificate of Incorporation of Arena (incorporated by reference to Exhibit 4.2 to Arena’s registration statement on Form S-8 filed with the Securities and Exchange Commission on June 28, 2006, Commission File No. 333-135398)
|
|
|
|
3.3
|
|
Certificate of Amendment No. 2 of the Fifth Amended and Restated Certificate of Incorporation of Arena, as amended (incorporated by reference to Exhibit 4.3 to Arena’s registration statement on Form S-8 filed with the Securities and Exchange Commission on June 30, 2009, Commission File No. 333-160329)
|
|
|
|
3.4
|
|
Certificate of Amendment No. 3 of the Fifth Amended and Restated Certificate of Incorporation of Arena, as amended (incorporated by reference to Exhibit 3.4 to Arena’s registration statement on Form S-8 filed with the Securities and Exchange Commission on June 20, 2012, Commission File No. 333-182238)
|
|
|
|
3.5
|
|
Amended and Restated Bylaws of Arena (incorporated by reference to Exhibit 3.1 to Arena’s current report on Form 8-K filed with the Securities and Exchange Commission on October 9, 2014, Commission File No. 000-31161)
|
|
|
|
4.4
|
|
Form of common stock certificate (incorporated by reference to Exhibit 4.2 to Arena’s registration statement on Form S-1, as amended, filed with the Securities and Exchange Commission on July 19, 2000, Commission File No. 333-35944)
|
|
|
|
10.1**
|
|
Amended and Restated 2000 Equity Compensation Plan (incorporated by reference to Exhibit 10.2 to Arena’s annual report on Form 10-K for the year ended December 31, 2001, filed with the Securities and Exchange Commission on March 15, 2002, Commission File No. 000-31161)
|
|
|
|
10.2**
|
|
2002 Equity Compensation Plan (incorporated by reference to Exhibit A to Arena’s proxy statement regarding Arena’s June 11, 2002, Annual Stockholders Meeting, filed with the Securities and Exchange Commission on April 23, 2002, Commission File No. 000-31161)
|
|
|
|
10.3
|
|
Purchase and Sale Agreement and Joint Escrow Instructions, dated December 22, 2003, between Arena and ARE—Nancy Ridge No. 3, LLC (incorporated by reference to Exhibit 10.1 to Arena’s current report on Form 8-K filed with the Securities and Exchange Commission on January 6, 2004, Commission File No. 000-31161)
|
|
|
|
10.4
|
|
Lease Agreement, dated December 30, 2003, between Arena and ARE—Nancy Ridge No. 3, LLC (incorporated by reference to Exhibit 10.2 to Arena’s current report on Form 8-K filed with the Securities and Exchange Commission on January 6, 2004, Commission File No. 000-31161)
|
|
|
|
10.5**
|
|
Arena’s Deferred Compensation Plan, effective November 11, 2003, between Arena and participating executive officers (incorporated by reference to Exhibit 10.29 to Arena’s annual report on Form 10-K for the year ended December 31, 2003, filed with the Securities and Exchange Commission on March 1, 2004, Commission File No. 000-31161)
|
|
|
|
EXHIBIT
NO.
|
|
DESCRIPTION
|
10.6**
|
|
2006 Long-Term Incentive Plan, as amended (incorporated by reference to Exhibit 10.1 to Arena’s current report on Form 8-K filed with the Securities and Exchange Commission on April 13, 2007, Commission File No. 000-31161)
|
|
|
|
10.7**
|
|
Form of Stock Option Grant Agreement under the Arena 2006 Long-Term Incentive Plan, as amended (incorporated by reference to Exhibit 10.1 to Arena’s current report on Form 8-K filed with the Securities and Exchange Commission on August 1, 2006, Commission File No. 000-31161)
|
|
|
|
10.8**
|
|
Form of Stock Option Grant Agreement—Director under the Arena 2006 Long-Term Incentive Plan, as amended (incorporated by reference to Exhibit 10.2 to Arena’s current report on Form 8-K filed with the Securities and Exchange Commission on August 1, 2006, Commission File No. 000-31161)
|
|
|
|
10.9**
|
|
Form of Incentive Stock Option Grant Agreement under the Arena 2006 Long-Term Incentive Plan, as amended (incorporated by reference to Exhibit 10.3 to Arena’s current report on Form 8-K filed with the Securities and Exchange Commission on August 1, 2006, Commission File No. 000-31161)
|
|
|
|
10.10**
|
|
Form of Indemnification Agreement between Arena and its directors (incorporated by reference to Exhibit 10.1 to Arena’s current report on Form 8-K filed with the Securities and Exchange Commission on June 18, 2007, Commission File No. 000-31161)
|
|
|
|
10.11**
|
|
Form of Indemnification Agreement between Arena and its executive officers (incorporated by reference to Exhibit 10.2 to Arena’s current report on Form 8-K filed with the Securities and Exchange Commission on June 18, 2007, Commission File No. 000-31161)
|
|
|
|
10.12**
|
|
Form of Indemnification Agreement between Arena and individuals serving as its directors and executive officers (incorporated by reference to Exhibit 10.3 to Arena’s current report on Form 8-K filed with the Securities and Exchange Commission on June 18, 2007, Commission File No. 000-31161)
|
|
|
|
10.13
|
|
Lease agreement between BMR-6114-6154 Nancy Ridge Drive LLC and Arena for 6114 Nancy Ridge Drive, San Diego, California (incorporated by reference to Exhibit 10.5 to Arena’s quarterly report on Form 10-Q for the quarter ended June 30, 2007, filed with the Securities and Exchange Commission on August 9, 2007, Commission File No. 000-31161)
|
|
|
|
10.14
|
|
Lease agreement between BMR-6114-6154 Nancy Ridge Drive LLC and Arena for 6118 Nancy Ridge Drive, San Diego, California (incorporated by reference to Exhibit 10.6 to Arena’s quarterly report on Form 10-Q for the quarter ended June 30, 2007, filed with the Securities and Exchange Commission on August 9, 2007, Commission File No. 000-31161)
|
|
|
|
10.15
|
|
Lease agreement between BMR-6114-6154 Nancy Ridge Drive LLC and Arena for 6122, 6124 and 6126 Nancy Ridge Drive, San Diego, California (incorporated by reference to Exhibit 10.7 to Arena’s quarterly report on Form 10-Q for the quarter ended June 30, 2007, filed with the Securities and Exchange Commission on August 9, 2007, Commission File No. 000-31161)
|
|
|
|
10.16
|
|
Lease agreement between BMR-6114-6154 Nancy Ridge Drive LLC and Arena for 6154 Nancy Ridge Drive, San Diego, California (incorporated by reference to Exhibit 10.8 to Arena’s quarterly report on Form 10-Q for the quarter ended June 30, 2007, filed with the Securities and Exchange Commission on August 9, 2007, Commission File No. 000-31161)
|
|
|
|
10.17*
|
|
Asset Purchase Agreement, dated as of December 18, 2007, by and between Arena Pharmaceuticals GmbH and Siegfried Ltd (incorporated by reference to Exhibit 10.38 to Arena’s annual report on Form 10-K for the year ended December 31, 2007, filed with the Securities and Exchange Commission on March 5, 2008, Commission File No. 000-31161)
|
|
|
|
10.18
|
|
Amendment No. 1 to the Asset Purchase Agreement, dated effective as of January 1, 2011, by and between Arena Pharmaceuticals GmbH and Siegfried Ltd (incorporated by reference to Exhibit 10.2 to Arena’s quarterly report on Form 10-Q for the quarter ended March 31, 2011, filed with the Securities and Exchange Commission on May 10, 2011, Commission File No. 000-31161)
|
|
|
|
10.19**
|
|
Amended and Restated Severance Benefit Plan, effective December 30, 2008, and providing benefits for Drs. Behan and Shanahan and Mr. Spector (incorporated by reference to Exhibit 10.1 to Arena’s Form 8-K filed with the Securities and Exchange Commission on December 31, 2008, Commission File No. 000-31161)
|
|
|
|
10.20**
|
|
Amendment No. 1 to Amended and Restated Severance Benefit Plan, dated as of February 10, 2012 (incorporated by reference to Exhibit 10.1 to Arena’s Form 8-K filed with the Securities and Exchange Commission on February 14, 2012, Commission File No. 000-31161)
|
|
|
|
EXHIBIT
NO.
|
|
DESCRIPTION
|
10.21**
|
|
Amendment No. 2 to Amended and Restated Severance Benefit Plan, dated as of October 4, 2013 (incorporated by reference to Exhibit 10.23 to Arena’s annual report on Form 10-K for the year ended December 31, 2013, filed with the Securities and Exchange Commission on March 3, 2014, Commission File No. 000-31161)
|
|
|
|
10.22**
|
|
Form of Amended and Restated Termination Protection Agreement, dated December 30, 2008, by and among Arena and Dr. Behan and Mr. Spector (incorporated by reference to Exhibit 10.2 to Arena’s Form 8-K filed with the Securities and Exchange Commission on December 31, 2008, Commission File No. 000-31161)
|
|
|
|
10.23**
|
|
Arena’s 2009 Long-Term Incentive Plan (incorporated by reference to Exhibit 99.1 to Arena’s registration statement on Form S-8 filed with the Securities and Exchange Commission on June 30, 2009, Commission File No. 333-160329)
|
|
|
|
10.24**
|
|
Form of Incentive Stock Option Grant Agreement for Employees under the Arena 2009 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.7 to Arena’s quarterly report on Form 10-Q for the quarter ended June 30, 2009, filed with the Securities and Exchange Commission on August 7, 2009, Commission File No. 000-31161)
|
|
|
|
10.25**
|
|
Form of Stock Option Grant Agreement for Employees or Consultants under the Arena 2009 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.8 to Arena’s quarterly report on Form 10-Q for the quarter ended June 30, 2009, filed with the Securities and Exchange Commission on August 7, 2009, Commission File No. 000-31161)
|
|
|
|
10.26**
|
|
Form of Stock Option Grant Agreement for Non-Employee Directors under the Arena 2009 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.9 to Arena’s quarterly report on Form 10-Q for the quarter ended June 30, 2009, filed with the Securities and Exchange Commission on August 7, 2009, Commission File No. 000-31161)
|
|
|
|
10.27**
|
|
Arena’s 2009 Employee Stock Purchase Plan, as amended (incorporated by reference to Exhibit 10.1 to Arena’s current report on Form 8-K filed with the Securities and Exchange Commission on June16, 2015, Commission File No. 000-31161)
|
|
|
|
10.28**
|
|
Arena’s 2012 Long-Term Incentive Plan (incorporated by reference to Exhibit 99.1 to Arena’s registration statement on Form S-8 filed with the Securities and Exchange Commission on June 20, 2012, Commission File No. 333-182238)
|
|
|
|
10.29**
|
|
Form of Incentive Stock Option Grant Agreement for Employees for grants prior to December 13, 2012, under the Arena 2012 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.3 to Arena’s current report on Form 8-K filed with the Securities and Exchange Commission on June 20, 2012, Commission File No. 000-31161)
|
|
|
|
10.30**
|
|
Form of Stock Option Grant Agreement for Employees or Consultants for grants prior to December 13, 2012, under the Arena 2012 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.4 to Arena’s current report on Form 8-K filed with the Securities and Exchange Commission on June 20, 2012, Commission File No. 000-31161)
|
|
|
|
10.31**
|
|
Form of Stock Option Grant Agreement for Non-Employee Directors under the Arena 2012 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.5 to Arena’s current report on Form 8-K filed with the Securities and Exchange Commission on June 20, 2012, Commission File No. 000-31161)
|
|
|
|
10.32**
|
|
Form of Restricted Stock Grant Agreement under the Arena 2012 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.6 to Arena’s current report on Form 8-K filed with the Securities and Exchange Commission on June 20, 2012, Commission File No. 000-31161)
|
|
|
|
10.33**
|
|
Form of Incentive Stock Option Grant Agreement for Employees for grants beginning on December 13, 2012, under the Arena 2012 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.45 to Arena’s annual report on Form 10-K for the year ended December 31, 2012, filed with the Securities and Exchange Commission on March 1, 2013, Commission File No. 000-31161)
|
|
|
|
10.34**
|
|
Form of Stock Option Grant Agreement for Employees or Consultants for grants beginning on December 13, 2012, under the Arena 2012 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.46 to Arena’s annual report on Form 10-K for the year ended December 31, 2012, filed with the Securities and Exchange Commission on March 1, 2013, Commission File No. 000-31161)
|
|
|
|
10.35**
|
|
Form of Restricted Stock Unit Grant Agreement under the Arena 2012 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.47 to Arena’s annual report on Form 10-K for the year ended December 31, 2012, filed with the Securities and Exchange Commission on March 1, 2013, Commission File No. 000-31161)
|
|
|
|
EXHIBIT
NO.
|
|
DESCRIPTION
|
10.36**
|
|
Form of Performance Restricted Stock Unit Grant Agreement under the Arena 2012 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.2 to Arena’s quarterly report on Form 10-Q for the quarter ended March 31, 2013, filed with the Securities and Exchange Commission on May 9, 2013, Commission File No. 000-31161)
|
|
|
|
10.37**
|
|
Arena’s 2013 Long-Term Incentive Plan (incorporated by reference to Exhibit 99.1 to Arena’s registration statement on Form S-8 filed with the Securities and Exchange Commission on June 10, 2013, Commission File No. 333-189213)
|
|
|
|
10.38**
|
|
Form of Stock Option Grant Agreement for Employees or Consultants under the Arena 2013 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.2 to Arena’s current report on Form 8-K filed with the Securities and Exchange Commission on June 14, 2013, Commission File No. 000-31161)
|
|
|
|
10.39**
|
|
Form of Incentive Stock Option Grant Agreement for Employees under the Arena 2013 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.3 to Arena’s current report on Form 8-K filed with the Securities and Exchange Commission on June 14, 2013, Commission File No. 000-31161)
|
|
|
|
10.40**
|
|
Form of Restricted Stock Unit Grant Agreement (other than for non-employee directors) under the Arena 2013 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.4 to Arena’s current report on Form 8-K filed with the Securities and Exchange Commission on June 14, 2013, Commission File No. 000-31161)
|
|
|
|
10.41**
|
|
Form of Restricted Stock Unit Grant Agreement for Non-Employee Directors under the Arena 2013 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.5 to Arena’s current report on Form 8-K filed with the Securities and Exchange Commission on June 14, 2013, Commission File No. 000-31161)
|
|
|
|
10.42**
|
|
Form of Performance Restricted Stock Unit Grant Agreement under the Arena 2013 Long-Term Incentive Plan
|
|
|
|
10.43**
|
|
Annual Incentive Plan for Arena’s executive officers (incorporated by reference to Exhibit 10.1 to Arena’s current report on Form 8-K filed with the Securities and Exchange Commission on December 19, 2012, Commission File No. 000-31161)
|
|
|
|
10.44**
|
|
Summary of compensation for non-employee directors (incorporated by reference to Exhibit 10.1 to Arena’s quarterly report on Form 10-Q for the quarter ended September 30, 2014, filed with the Securities and Exchange Commission on November 6, 2014, Commission File No. 000-31161)
|
|
|
|
10.45+
|
|
Second Amended and Restated Marketing and Supply Agreement, dated November 7, 2013, by and among Arena Pharmaceuticals GmbH, Eisai Inc. and Eisai Co., Ltd. (incorporated by reference to Exhibit 10.46 to Arena’s annual report on Form 10-K for the year ended December 31, 2013, filed with the Securities and Exchange Commission on March 3, 2014, Commission File No. 000-31161)
|
|
|
|
10.46**
|
|
Services Agreement, dated July 9, 2015, by and between Arena and Robert E. Hoffman (incorporated by reference to Exhibit 10.1 to Arena’s current report on Form 8-K filed with the Securities and Exchange Commission on July 9, 2015, Commission File No. 000-31161)
|
|
|
|
10.47**
|
|
Separation agreement with Arena and Jack Lief, dated October 5, 2015
|
|
|
|
10.48**
|
|
Interim CEO Employment Agreement with Arena and Harry F. Hixson, Jr., Ph.D., dated October 5, 2015
|
|
|
|
21.1
|
|
Subsidiaries of the registrant
|
|
|
|
23.1
|
|
Consent of Independent Registered Public Accounting Firm
|
|
|
|
31.1
|
|
Certification of principal executive and financial officer pursuant to Rule 13a-14(A) promulgated under the Securities Exchange Act of 1934
|
|
|
|
32.1
|
|
Certification of principal executive and financial officer pursuant to 18 U.S.C. Section 1350 and Rule 13a-14(B) promulgated under the Securities Exchange Act of 1934
|
|
|
|
101.INS
|
|
XBRL Instance Document
|
|
|
|
101.SCH
|
|
XBRL Taxonomy Extension Schema Document
|
|
|
|
101.CAL
|
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
|
|
|
101.DEF
|
|
XBRL Taxonomy Extension Definition Linkbase Document
|
|
|
|
101.LAB
|
|
XBRL Taxonomy Extension Label Linkbase Document
|
|
|
|
101.PRE
|
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
|
+
|
Confidential treatment has been granted with respect to certain portions of this exhibit. Omitted portions have been filed separately with the Securities and Exchange Commission.
|
*
|
Exhibits and schedules to this agreement have been omitted pursuant to the rules of the Securities and Exchange Commission. We will submit copies of such exhibits and schedules to the Securities and Exchange Commission upon request.
|
**
|
Management contract or compensatory plan or arrangement.
|
|
Arena Pharmaceuticals, Inc.,
a Delaware corporation
|
|
|
|
|
Date: February 29, 2016
|
By:
|
/
S
/ HARRY F. HIXSON, JR.
|
|
|
Harry F. Hixson, Jr., Ph.D.
Interim Chief Executive Officer
|
Signatures
|
|
Title
|
|
Date
|
||
|
|
|
|
|
|
|
By:
|
|
/
S
/ H
ARRY
F. H
IXSON
, J
R
.
|
|
Interim Chief Executive Officer and Director (principal executive and financial officer)
|
|
February 29, 2016
|
|
|
Harry F. Hixson, Jr., Ph.D.
|
|
|
|
|
|
|
|
|
|
|
|
By:
|
|
/
S
/ J
ENNIFER
K. B
IELASZ
|
|
Vice President, Finance and Accounting (principal accounting officer)
|
|
February 29, 2016
|
|
|
Jennifer K. Bielasz
|
|
|
|
|
|
|
|
|
|
|
|
By:
|
|
/
S
/ D
OMINIC
P. B
EHAN
|
|
Director
|
|
February 29, 2016
|
|
|
Dominic P. Behan, Ph.D., D.Sc.
|
|
|
|
|
|
|
|
|
|
|
|
By:
|
|
/
S
/ D
ONALD
D. B
ELCHER
|
|
Director
|
|
February 29, 2016
|
|
|
Donald D. Belcher
|
|
|
|
|
|
|
|
|
|
|
|
By:
|
|
/
S
/ S
COTT
H. B
ICE
|
|
Director
|
|
February 29, 2016
|
|
|
Scott H. Bice
|
|
|
|
|
|
|
|
|
|
|
|
By:
|
|
/
S
/ T
INA
S. N
OVA
|
|
Director
|
|
February 29, 2016
|
|
|
Tina S. Nova, Ph.D.
|
|
|
|
|
|
|
|
|
|
|
|
By:
|
|
/
S
/ P
HILLIP
M. S
CHNEIDER
|
|
Director
|
|
February 29, 2016
|
|
|
Phillip M. Schneider
|
|
|
|
|
|
|
|
|
|
|
|
By:
|
|
/
S
/ C
HRISTINE
A. W
HITE
|
|
Director
|
|
February 29, 2016
|
|
|
Christine A. White, M.D.
|
|
|
|
|
|
|
|
|
|
|
|
By:
|
|
/
S
/ R
ANDALL
E. W
OODS
|
|
Director
|
|
February 29, 2016
|
|
|
Randall E. Woods
|
|
|
|
|
EXHIBIT
NO.
|
|
|
|
|
|
2.1*
|
|
Agreement of Purchase and Sale, dated as of March 21, 2007, by and between Arena and BMR-6114-6154 Nancy Ridge Drive LLP (as assignee of BioMed Realty, L.P.) (incorporated by reference to Exhibit 2.1 to Arena’s current report on Form 8-K filed with the Securities and Exchange Commission on May 8, 2007, Commission File No. 000-31161)
|
|
|
|
3.1
|
|
Fifth Amended and Restated Certificate of Incorporation of Arena (incorporated by reference to Exhibit 3.1 to Arena’s quarterly report on Form 10-Q for the quarter ended June 30, 2002, filed with the Securities and Exchange Commission on August 14, 2002, Commission File No. 000-31161)
|
|
|
|
3.2
|
|
Certificate of Amendment of the Fifth Amended and Restated Certificate of Incorporation of Arena (incorporated by reference to Exhibit 4.2 to Arena’s registration statement on Form S-8 filed with the Securities and Exchange Commission on June 28, 2006, Commission File No. 333-135398)
|
|
|
|
3.3
|
|
Certificate of Amendment No. 2 of the Fifth Amended and Restated Certificate of Incorporation of Arena, as amended (incorporated by reference to Exhibit 4.3 to Arena’s registration statement on Form S-8 filed with the Securities and Exchange Commission on June 30, 2009, Commission File No. 333-160329)
|
|
|
|
3.4
|
|
Certificate of Amendment No. 3 of the Fifth Amended and Restated Certificate of Incorporation of Arena, as amended (incorporated by reference to Exhibit 3.4 to Arena’s registration statement on Form S-8 filed with the Securities and Exchange Commission on June 20, 2012, Commission File No. 333-182238)
|
|
|
|
3.5
|
|
Amended and Restated Bylaws of Arena (incorporated by reference to Exhibit 3.1 to Arena’s current report on Form 8-K filed with the Securities and Exchange Commission on October 9, 2014, Commission File No. 000-31161)
|
|
|
|
4.4
|
|
Form of common stock certificate (incorporated by reference to Exhibit 4.2 to Arena’s registration statement on Form S-1, as amended, filed with the Securities and Exchange Commission on July 19, 2000, Commission File No. 333-35944)
|
|
|
|
10.1**
|
|
Amended and Restated 2000 Equity Compensation Plan (incorporated by reference to Exhibit 10.2 to Arena’s annual report on Form 10-K for the year ended December 31, 2001, filed with the Securities and Exchange Commission on March 15, 2002, Commission File No. 000-31161)
|
|
|
|
10.2**
|
|
2002 Equity Compensation Plan (incorporated by reference to Exhibit A to Arena’s proxy statement regarding Arena’s June 11, 2002, Annual Stockholders Meeting, filed with the Securities and Exchange Commission on April 23, 2002, Commission File No. 000-31161)
|
|
|
|
10.3
|
|
Purchase and Sale Agreement and Joint Escrow Instructions, dated December 22, 2003, between Arena and ARE—Nancy Ridge No. 3, LLC (incorporated by reference to Exhibit 10.1 to Arena’s current report on Form 8-K filed with the Securities and Exchange Commission on January 6, 2004, Commission File No. 000-31161)
|
|
|
|
10.4
|
|
Lease Agreement, dated December 30, 2003, between Arena and ARE—Nancy Ridge No. 3, LLC (incorporated by reference to Exhibit 10.2 to Arena’s current report on Form 8-K filed with the Securities and Exchange Commission on January 6, 2004, Commission File No. 000-31161)
|
|
|
|
10.5**
|
|
Arena’s Deferred Compensation Plan, effective November 11, 2003, between Arena and participating executive officers (incorporated by reference to Exhibit 10.29 to Arena’s annual report on Form 10-K for the year ended December 31, 2003, filed with the Securities and Exchange Commission on March 1, 2004, Commission File No. 000-31161)
|
|
|
|
10.6**
|
|
2006 Long-Term Incentive Plan, as amended (incorporated by reference to Exhibit 10.1 to Arena’s current report on Form 8-K filed with the Securities and Exchange Commission on April 13, 2007, Commission File No. 000-31161)
|
|
|
|
10.7**
|
|
Form of Stock Option Grant Agreement under the Arena 2006 Long-Term Incentive Plan, as amended (incorporated by reference to Exhibit 10.1 to Arena’s current report on Form 8-K filed with the Securities and Exchange Commission on August 1, 2006, Commission File No. 000-31161)
|
|
|
|
10.8**
|
|
Form of Stock Option Grant Agreement—Director under the Arena 2006 Long-Term Incentive Plan, as amended (incorporated by reference to Exhibit 10.2 to Arena’s current report on Form 8-K filed with the Securities and Exchange Commission on August 1, 2006, Commission File No. 000-31161)
|
|
|
|
10.9**
|
|
Form of Incentive Stock Option Grant Agreement under the Arena 2006 Long-Term Incentive Plan, as amended (incorporated by reference to Exhibit 10.3 to Arena’s current report on Form 8-K filed with the Securities and Exchange Commission on August 1, 2006, Commission File No. 000-31161)
|
|
|
|
EXHIBIT
NO.
|
|
|
10.10**
|
|
Form of Indemnification Agreement between Arena and its directors (incorporated by reference to Exhibit 10.1 to Arena’s current report on Form 8-K filed with the Securities and Exchange Commission on June 18, 2007, Commission File No. 000-31161)
|
|
|
|
10.11**
|
|
Form of Indemnification Agreement between Arena and its executive officers (incorporated by reference to Exhibit 10.2 to Arena’s current report on Form 8-K filed with the Securities and Exchange Commission on June 18, 2007, Commission File No. 000-31161)
|
|
|
|
10.12**
|
|
Form of Indemnification Agreement between Arena and individuals serving as its directors and executive officers (incorporated by reference to Exhibit 10.3 to Arena’s current report on Form 8-K filed with the Securities and Exchange Commission on June 18, 2007, Commission File No. 000-31161)
|
|
|
|
10.13
|
|
Lease agreement between BMR-6114-6154 Nancy Ridge Drive LLC and Arena for 6114 Nancy Ridge Drive, San Diego, California (incorporated by reference to Exhibit 10.5 to Arena’s quarterly report on Form 10-Q for the quarter ended June 30, 2007, filed with the Securities and Exchange Commission on August 9, 2007, Commission File No. 000-31161)
|
|
|
|
10.14
|
|
Lease agreement between BMR-6114-6154 Nancy Ridge Drive LLC and Arena for 6118 Nancy Ridge Drive, San Diego, California (incorporated by reference to Exhibit 10.6 to Arena’s quarterly report on Form 10-Q for the quarter ended June 30, 2007, filed with the Securities and Exchange Commission on August 9, 2007, Commission File No. 000-31161)
|
|
|
|
10.15
|
|
Lease agreement between BMR-6114-6154 Nancy Ridge Drive LLC and Arena for 6122, 6124 and 6126 Nancy Ridge Drive, San Diego, California (incorporated by reference to Exhibit 10.7 to Arena’s quarterly report on Form 10-Q for the quarter ended June 30, 2007, filed with the Securities and Exchange Commission on August 9, 2007, Commission File No. 000-31161)
|
|
|
|
10.16
|
|
Lease agreement between BMR-6114-6154 Nancy Ridge Drive LLC and Arena for 6154 Nancy Ridge Drive, San Diego, California (incorporated by reference to Exhibit 10.8 to Arena’s quarterly report on Form 10-Q for the quarter ended June 30, 2007, filed with the Securities and Exchange Commission on August 9, 2007, Commission File No. 000-31161)
|
|
|
|
10.17*
|
|
Asset Purchase Agreement, dated as of December 18, 2007, by and between Arena Pharmaceuticals GmbH and Siegfried Ltd (incorporated by reference to Exhibit 10.38 to Arena’s annual report on Form 10-K for the year ended December 31, 2007, filed with the Securities and Exchange Commission on March 5, 2008, Commission File No. 000-31161)
|
|
|
|
10.18
|
|
Amendment No. 1 to the Asset Purchase Agreement, dated effective as of January 1, 2011, by and between Arena Pharmaceuticals GmbH and Siegfried Ltd (incorporated by reference to Exhibit 10.2 to Arena’s quarterly report on Form 10-Q for the quarter ended March 31, 2011, filed with the Securities and Exchange Commission on May 10, 2011, Commission File No. 000-31161)
|
|
|
|
10.19**
|
|
Amended and Restated Severance Benefit Plan, effective December 30, 2008, and providing benefits for Drs. Behan and Shanahan and Mr. Spector (incorporated by reference to Exhibit 10.1 to Arena’s Form 8-K filed with the Securities and Exchange Commission on December 31, 2008, Commission File No. 000-31161)
|
|
|
|
10.20**
|
|
Amendment No. 1 to Amended and Restated Severance Benefit Plan, dated as of February 10, 2012 (incorporated by reference to Exhibit 10.1 to Arena’s Form 8-K filed with the Securities and Exchange Commission on February 14, 2012, Commission File No. 000-31161)
|
|
|
|
10.21**
|
|
Amendment No. 2 to Amended and Restated Severance Benefit Plan, dated as of October 4, 2013 (incorporated by reference to Exhibit 10.23 to Arena’s annual report on Form 10-K for the year ended December 31, 2013, filed with the Securities and Exchange Commission on March 3, 2014, Commission File No. 000-31161)
|
|
|
|
10.22**
|
|
Form of Amended and Restated Termination Protection Agreement, dated December 30, 2008, by and among Arena and Dr. Behan and Mr. Spector (incorporated by reference to Exhibit 10.2 to Arena’s Form 8-K filed with the Securities and Exchange Commission on December 31, 2008, Commission File No. 000-31161)
|
|
|
|
10.23**
|
|
Arena’s 2009 Long-Term Incentive Plan (incorporated by reference to Exhibit 99.1 to Arena’s registration statement on Form S-8 filed with the Securities and Exchange Commission on June 30, 2009, Commission File No. 333-160329)
|
|
|
|
10.24**
|
|
Form of Incentive Stock Option Grant Agreement for Employees under the Arena 2009 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.7 to Arena’s quarterly report on Form 10-Q for the quarter ended June 30, 2009, filed with the Securities and Exchange Commission on August 7, 2009, Commission File No. 000-31161)
|
|
|
|
EXHIBIT
NO.
|
|
|
10.25**
|
|
Form of Stock Option Grant Agreement for Employees or Consultants under the Arena 2009 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.8 to Arena’s quarterly report on Form 10-Q for the quarter ended June 30, 2009, filed with the Securities and Exchange Commission on August 7, 2009, Commission File No. 000-31161)
|
|
|
|
10.26**
|
|
Form of Stock Option Grant Agreement for Non-Employee Directors under the Arena 2009 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.9 to Arena’s quarterly report on Form 10-Q for the quarter ended June 30, 2009, filed with the Securities and Exchange Commission on August 7, 2009, Commission File No. 000-31161)
|
|
|
|
10.27**
|
|
Arena’s 2009 Employee Stock Purchase Plan, as amended (incorporated by reference to Exhibit 10.1 to Arena’s current report on Form 8-K filed with the Securities and Exchange Commission on June16, 2015, Commission File No. 000-31161)
|
|
|
|
10.28**
|
|
Arena’s 2012 Long-Term Incentive Plan (incorporated by reference to Exhibit 99.1 to Arena’s registration statement on Form S-8 filed with the Securities and Exchange Commission on June 20, 2012, Commission File No. 333-182238)
|
|
|
|
10.29**
|
|
Form of Incentive Stock Option Grant Agreement for Employees for grants prior to December 13, 2012, under the Arena 2012 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.3 to Arena’s current report on Form 8-K filed with the Securities and Exchange Commission on June 20, 2012, Commission File No. 000-31161)
|
|
|
|
10.30**
|
|
Form of Stock Option Grant Agreement for Employees or Consultants for grants prior to December 13, 2012, under the Arena 2012 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.4 to Arena’s current report on Form 8-K filed with the Securities and Exchange Commission on June 20, 2012, Commission File No. 000-31161)
|
|
|
|
10.31**
|
|
Form of Stock Option Grant Agreement for Non-Employee Directors under the Arena 2012 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.5 to Arena’s current report on Form 8-K filed with the Securities and Exchange Commission on June 20, 2012, Commission File No. 000-31161)
|
|
|
|
10.32**
|
|
Form of Restricted Stock Grant Agreement under the Arena 2012 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.6 to Arena’s current report on Form 8-K filed with the Securities and Exchange Commission on June 20, 2012, Commission File No. 000-31161)
|
|
|
|
10.33**
|
|
Form of Incentive Stock Option Grant Agreement for Employees for grants beginning on December 13, 2012, under the Arena 2012 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.45 to Arena’s annual report on Form 10-K for the year ended December 31, 2012, filed with the Securities and Exchange Commission on March 1, 2013, Commission File No. 000-31161)
|
|
|
|
10.34**
|
|
Form of Stock Option Grant Agreement for Employees or Consultants for grants beginning on December 13, 2012, under the Arena 2012 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.46 to Arena’s annual report on Form 10-K for the year ended December 31, 2012, filed with the Securities and Exchange Commission on March 1, 2013, Commission File No. 000-31161)
|
|
|
|
10.35**
|
|
Form of Restricted Stock Unit Grant Agreement under the Arena 2012 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.47 to Arena’s annual report on Form 10-K for the year ended December 31, 2012, filed with the Securities and Exchange Commission on March 1, 2013, Commission File No. 000-31161)
|
|
|
|
10.36**
|
|
Form of Performance Restricted Stock Unit Grant Agreement under the Arena 2012 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.2 to Arena’s quarterly report on Form 10-Q for the quarter ended March 31, 2013, filed with the Securities and Exchange Commission on May 9, 2013, Commission File No. 000-31161)
|
|
|
|
10.37**
|
|
Arena’s 2013 Long-Term Incentive Plan (incorporated by reference to Exhibit 99.1 to Arena’s registration statement on Form S-8 filed with the Securities and Exchange Commission on June 10, 2013, Commission File No. 333-189213)
|
|
|
|
10.38**
|
|
Form of Stock Option Grant Agreement for Employees or Consultants under the Arena 2013 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.2 to Arena’s current report on Form 8-K filed with the Securities and Exchange Commission on June 14, 2013, Commission File No. 000-31161)
|
|
|
|
10.39**
|
|
Form of Incentive Stock Option Grant Agreement for Employees under the Arena 2013 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.3 to Arena’s current report on Form 8-K filed with the Securities and Exchange Commission on June 14, 2013, Commission File No. 000-31161)
|
|
|
|
EXHIBIT
NO.
|
|
|
10.40**
|
|
Form of Restricted Stock Unit Grant Agreement (other than for non-employee directors) under the Arena 2013 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.4 to Arena’s current report on Form 8-K filed with the Securities and Exchange Commission on June 14, 2013, Commission File No. 000-31161)
|
|
|
|
10.41**
|
|
Form of Restricted Stock Unit Grant Agreement for Non-Employee Directors under the Arena 2013 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.5 to Arena’s current report on Form 8-K filed with the Securities and Exchange Commission on June 14, 2013, Commission File No. 000-31161)
|
|
|
|
10.42**
|
|
Form of Performance Restricted Stock Unit Grant Agreement under the Arena 2013 Long-Term Incentive Plan
|
|
|
|
10.43**
|
|
Annual Incentive Plan for Arena’s executive officers (incorporated by reference to Exhibit 10.1 to Arena’s current report on Form 8-K filed with the Securities and Exchange Commission on December 19, 2012, Commission File No. 000-31161)
|
|
|
|
10.44**
|
|
Summary of compensation for non-employee directors (incorporated by reference to Exhibit 10.1 to Arena’s quarterly report on Form 10-Q for the quarter ended September 30, 2014, filed with the Securities and Exchange Commission on November 6, 2014, Commission File No. 000-31161)
|
|
|
|
10.45+
|
|
Second Amended and Restated Marketing and Supply Agreement, dated November 7, 2013, by and among Arena Pharmaceuticals GmbH, Eisai Inc. and Eisai Co., Ltd. (incorporated by reference to Exhibit 10.46 to Arena’s annual report on Form 10-K for the year ended December 31, 2013, filed with the Securities and Exchange Commission on March 3, 2014, Commission File No. 000-31161)
|
|
|
|
10.46**
|
|
Services Agreement, dated July 9, 2015, by and between Arena and Robert E. Hoffman (incorporated by reference to Exhibit 10.1 to Arena’s current report on Form 8-K filed with the Securities and Exchange Commission on July 9, 2015, Commission File No. 000-31161)
|
|
|
|
10.47**
|
|
Separation agreement with Arena and Jack Lief, dated October 5, 2015
|
|
|
|
10.48**
|
|
Interim CEO Employment Agreement with Arena and Harry F. Hixson, Jr., Ph.D., dated October 5, 2015
|
|
|
|
21.1
|
|
Subsidiaries of the registrant
|
|
|
|
23.1
|
|
Consent of Independent Registered Public Accounting Firm
|
|
|
|
31.1
|
|
Certification of principal executive and financial officer pursuant to Rule 13a-14(A) promulgated under the Securities Exchange Act of 1934
|
|
|
|
32.1
|
|
Certification of principal executive and financial officer pursuant to 18 U.S.C. Section 1350 and Rule 13a-14(B) promulgated under the Securities Exchange Act of 1934
|
|
|
|
101.INS
|
|
XBRL Instance Document
|
|
|
|
101.SCH
|
|
XBRL Taxonomy Extension Schema Document
|
|
|
|
101.CAL
|
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
|
|
|
101.DEF
|
|
XBRL Taxonomy Extension Definition Linkbase Document
|
|
|
|
101.LAB
|
|
XBRL Taxonomy Extension Label Linkbase Document
|
|
|
|
101.PRE
|
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
|
+
|
Confidential treatment has been granted with respect to certain portions of this exhibit. Omitted portions have been filed separately with the Securities and Exchange Commission.
|
*
|
Exhibits and schedules to this agreement have been omitted pursuant to the rules of the Securities and Exchange Commission. We will submit copies of such exhibits and schedules to the Securities and Exchange Commission upon request.
|
**
|
Management contract or compensatory plan or arrangement.
|
•
|
New entrants to the NASDAQ Biotechnology Index after December 31, 20[ ], are not considered part of the Index.
|
•
|
Any company that falls out of the NASDAQ Biotechnology Index prior to the end of the Performance Period, but continues actively trading on a U.S. public securities market or exchange, remains in the Index.
|
•
|
The TSR for an Index Peer Company will be deemed to be -100% if, during the Performance Period, such company: (i) files for bankruptcy, reorganization, or liquidation under any chapter of the U.S. Bankruptcy Code; (ii) is the subject of an involuntary bankruptcy proceeding that is not dismissed within 30 days; (iii) is the subject of a stockholder approved plan of liquidation or dissolution; or (iv) ceases to conduct substantial business operations.
|
•
|
Any Index Peer Company that stops actively trading on a U.S. public securities market or exchange before the end of the Performance Period for reasons unrelated to such a bankruptcy related event (for e.g., due to an acquisition of the Index Peer Company, a going-private transaction, etc.) is excluded from the Index for purposes of the Index TSR calculation.
|
•
|
The number of PRSUs that may vest is capped at the lower of (i) 200% of the Target PRSUs, before including additional PRSUs credited as dividend equivalents and (ii) the Value Cap. Subject to such maximum, the actual number of PRSUs that may vest will be determined as set forth in the following chart based upon the indicated performance levels with linear interpolation between performance levels:
|
Performance
|
The Company’s TSR Rank vs. Index (as a Percentile)
|
Payout Percentage of
Target PRSUs
|
Maximum
|
90
th
and above
|
200%
|
|
75
th
|
150%
|
Target
|
60
th
|
100%
|
|
50
th
|
75%
|
Threshold
|
40
th
|
50%
|
•
|
If the Company’s TSR is less than the 40
th
percentile of the TSR of the Index, no PRSUs will vest.
|
•
|
If the Company’s absolute TSR is negative, the number of PRSUs that may vest is capped at 100% of the Target PRSUs, even if the percentile of the Company’s TSR as compared to the TSR of the Index is above the 60
th
percentile.
|
ARENA PHARMACEUTICALS, INC.
By:
/s/ Tina S. Nova
Tina S. Nova, Ph.D.
Director
EXECUTIVE:
/s/ Harry F. Hixson
Harry F. Hixson, Jr., Ph.D.
|
|
|
/s/ KPMG LLP
|
a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under my supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to me by others within those entities, particularly during the period in which this annual report is being prepared;
|
b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under my supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this annual report my conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this annual report based on such evaluation; and
|
d)
|
Disclosed in this annual report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
Date: February 29, 2016
|
|
/s/ HARRY F. HIXSON, JR.
|
|
|
Harry F. Hixson, Jr., Ph.D., interim Chief Executive Officer
|
|
|
(principal executive and financial officer)
|
2.
|
the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
/s/ HARRY F. HIXSON, JR.
|
|
Harry F. Hixson, Jr., Ph.D.,
|
|
Interim Chief Executive Officer
|
|
(principal executive and financial officer)
|
|
|
|
Date: February 29, 2016
|
|