x
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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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Washington
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91-1533912
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(State or other jurisdiction of incorporation or organization)
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(I.R.S. Employer Identification Number)
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3101 Western Avenue, Suite 600
Seattle, WA
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98121
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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, no par value
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The NASDAQ Stock Market LLC
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Large accelerated filer
¨
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Accelerated filer
x
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Non-accelerated filer
¨
(Do not check if a smaller reporting company)
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Smaller reporting company
¨
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Page
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ITEM 1.
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ITEM 1A.
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ITEM 1B.
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ITEM 2.
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ITEM 3.
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ITEM 4.
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ITEM 5.
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ITEM 6.
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ITEM 7.
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ITEM 7A.
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ITEM 8.
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ITEM 9.
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ITEM 9A.
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ITEM 9B.
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ITEM 10.
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ITEM 11.
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ITEM 12.
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ITEM 13.
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ITEM 14.
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ITEM 15.
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ITEM 16.
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CERTIFICATIONS
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•
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any statements regarding future operations, plans, expectations, intentions, regulatory filings or approvals;
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•
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any statements regarding the performance, or likely performance, outcomes or economic benefit of any licensing collaboration or other arrangement;
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•
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any projections of revenues, operating expenses or other financial terms, and any projections of cash resources, including regarding our potential receipt of future milestone payments under any of our agreements with third parties and expected sales of PIXUVRI;
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•
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any statements of the plans and objectives of management for future operations or programs;
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•
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any statements concerning proposed new products;
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•
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any statements regarding the safety and efficacy or future availability of any of our compounds;
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•
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any statements regarding our ability to interpret clinical trial data and results or expectations with respect to the potential therapeutic utility of pacritinib and the prevalence of myelofibrosis in the U.S.;
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•
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any statements on plans regarding proposed or potential clinical trials or new drug filing strategies, timelines or submissions, including expectations with respect to the timing and planned enrollment of PAC203;
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•
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any significant disruptions in our information technology systems;
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•
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any statements regarding compliance with the listing standards of The NASDAQ Stock Market and the Mercato Telemarico Azionario, or the MTA, in Italy;
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•
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any statements regarding potential future partnerships, licensing arrangements, mergers, acquisitions or other transactions;
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•
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any statements regarding future economic conditions or performance; and
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•
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any statements of assumption underlying any of the foregoing.
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•
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Commercialize PIXUVRI.
Together with Servier, we intend to continue our efforts to build a successful PIXUVRI franchise in Europe as well as other markets. We and our partner are currently focused on educating physicians on the unmet medical need and building brand awareness for PIXUVRI among physicians in the countries where PIXUVRI is available. A successful outcome from the post-authorization trial, PIX306, will enable us to potentially obtain full marketing authorization from the European Commission and expand the market potential for PIXUVRI.
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•
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Develop Pacritinib in Myelofibrosis and Additional Indications.
We intend to develop and commercialize pacritinib for adult patients with myelofibrosis and potentially additional indications.
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•
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Continue to Develop Tosedostat for AML and MDS.
We intend to continue to develop our earlier stage candidate tosedostat for the treatment of AML and MDS currently through cooperative group sponsored trials and ISTs. Sponsoring such trials provides us with a more economical approach for further developing our investigational products.
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•
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Evaluate Strategic Product Collaborations to Accelerate Development and Commercialization.
Where we believe it may be beneficial, we intend to evaluate additional collaborations to broaden and accelerate clinical trial development and potential commercialization of our product candidates. Collaborations have the potential to generate non-equity based operating capital, supplement our own internal expertise and provide us with access to the marketing, sales and distribution capabilities of our collaborators in specific territories.
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•
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Identify and Acquire Additional Pipeline Opportunities.
Our current pipeline is the result of licensing and acquiring assets that we believe were initially undervalued opportunities. We plan to continue to seek out additional product candidates in an opportunistic manner.
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Indications/Intended Use
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Status
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PIXUVRI
(pixantrone)
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Multiply relapsed aggressive B-cell NHL
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Marketed in E.U.; Conditional Marketing Authorization
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Aggressive NHL, 2nd line >1 relapse, combination with rituximab (PIX306) post-approval study
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Phase 3: Enrollment ongoing
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Pacritinib
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Myelofibrosis, PERSIST-1, All platelet levels
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Phase 3: Trial completed; Final results presented at medical meeting
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Myelofibrosis, PERSIST-2, Platelet counts ≤100,000/µL
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Phase 3: Trial completed; Final results presented at medical meeting
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Other hematological and solid tumor indications
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Phase 2: Multiple studies ongoing(1)
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Tosedostat
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AML/MDS
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Phase 2: Multiple studies ongoing(1)
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(1)
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We support the development of these investigational agents through cooperative group sponsored trials and ISTs.
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Pacritinib
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BAT
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p-value
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All Platelet Levels
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|||
ITT*
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19.1% (n=220)
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4.7% (n=107)
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0.0003
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Evaluable**
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25.0% (n=168)
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5.9% (n=85)
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<0.0001
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<
100,000/µL platelets
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ITT
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16.7% (n=72)
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0% (n=34)
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0.0086
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Evaluable
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23.5% (n=51)
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0% (n=24)
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0.0072
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<
50,000/µL platelets
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ITT
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22.9% (n=35)
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0% (n=16)
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0.0451
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Evaluable
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33.3% (n=24)
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0% (n=11)
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0.0370
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Co-Primary
Pacritinib BID + QD (n=149)
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Secondary
Pacritinib BID
(n=74)
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Secondary
Pacritinib QD
(n=75)
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BAT
(n=72)
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Percent of Patients with ≥35% SVR from baseline to Week 24
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18%
(n=27;p=0.001)
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22%
(n=16;p=0.001)
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15%
(n=11;p=0.017)
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3%
(n=2)
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Percent of Patients with ≥50% reduction in TSS from baseline to Week 24
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25%
(n=37;p=0.079)
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32%
(n=24;p=0.011)
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17%
(n=13;p=0.652)
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14%
(n=10)
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•
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Phase 1 clinical trials include the initial administration of the investigational drug to humans, typically to a small group of healthy human subjects, but occasionally to a group of patients with the targeted disease or disorder. Phase 1 clinical trials generally are intended to determine the metabolism and pharmacologic actions of the drug, the side effects associated with increasing doses, and, if possible, to gain early evidence of effectiveness.
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•
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Phase 2 clinical trials generally are controlled studies that involve a relatively small sample of the intended patient population, and are designed to develop data regarding the product’s effectiveness, to determine dose response and the optimal dose range and to gather additional information relating to safety and potential adverse effects.
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Phase 3 clinical trials are conducted after preliminary evidence of effectiveness has been obtained, and are intended to gather the additional information about safety and effectiveness necessary to evaluate the drug’s overall risk-benefit profile, and to provide a basis for physician labeling. Generally, Phase 3 clinical development programs consist of
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•
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our ability to raise capital through the issuance of additional shares of our common stock or convertible securities is restricted by the limited number of our residual authorized shares, the potential difficulty of obtaining shareholder approval to increase authorized shares and the restrictive covenants under our senior secured term loan agreement;
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issuance of equity-based securities will dilute the proportionate ownership of existing shareholders;
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our ability to obtain further funds from any potential loan arrangements is limited by our existing senior secured term loan agreement;
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certain financing arrangements may require us to relinquish rights to various assets and/or impose more restrictive terms than any of our existing or past arrangements; and
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•
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we may be required to meet additional regulatory requirements, and we may be subject to certain contractual limitations, which may increase our costs and harm our ability to obtain funding.
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delay or failure in obtaining necessary U.S. and international regulatory approvals, or the imposition of a partial or full regulatory hold on a clinical trial;
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difficulties in formulating a compound, scaling the manufacturing process, timely attaining process validation for particular drug products and obtaining manufacturing approval;
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pricing or reimbursement issues or other factors that may make the product uneconomical to commercialize;
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production problems, such as the inability to obtain raw materials or supplies satisfying acceptable standards for the manufacture of our products, equipment obsolescence, malfunctions or failures, product quality/contamination problems or changes in regulations requiring manufacturing modifications;
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inefficient cost structure of a compound compared to alternative treatments;
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obstacles resulting from proprietary rights held by others with respect to a compound, such as patent rights;
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lower than anticipated rates of patient enrollment as a result of factors, such as the number of patients with the relevant conditions, the proximity of patients to clinical testing centers, eligibility criteria for tests and competition with other clinical testing programs;
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preclinical or clinical testing requiring significantly more time than expected, resources or expertise than originally expected and inadequate financing, which could cause clinical trials to be delayed or terminated;
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failure of clinical testing to show potential products to be safe and efficacious, and failure to demonstrate desired safety and efficacy characteristics in human clinical trials;
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suspension of a clinical trial at any time by us, an applicable collaboration partner or a regulatory authority on the basis that the participants are being exposed to unacceptable health risks or for other reasons;
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delays in reaching or failing to reach agreement on acceptable terms with prospective CROs, and trial sites; and
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failure of third parties, such as CROs, academic institutions, collaborators, cooperative groups and/or investigator sponsors, to conduct, oversee and monitor clinical trials and results.
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•
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a compound may not be shown to be safe or effective;
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the clinical and other benefits of a compound may not outweigh its safety risks;
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clinical trial results may be negative or inconclusive, or adverse medical events may occur during a clinical trial;
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the results of clinical trials may not meet the level of statistical significance required by regulatory agencies for approval;
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such regulatory agencies may interpret data from pre-clinical and clinical trials in different ways than we do;
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such regulatory agencies may not approve the manufacturing process of a compound or determine that a third party contract manufacturers manufactures a compound in accordance with current good manufacturing practices, or cGMPs;
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a compound may fail to comply with regulatory requirements; or
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such regulatory agencies might change their approval policies or adopt new regulations.
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they may be found ineffective or cause harmful side effects;
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they may be difficult to manufacture on a scale necessary for commercialization;
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they may experience excessive product loss due to contamination, equipment failure, inadequate transportation or storage, improper installation or operation of equipment, vendor or operator error, inconsistency in yields or variability in product characteristics;
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they may be uneconomical to produce;
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political and legislative changes emerging after the recent election of the President of the United States may make the commercialization of our product candidates more difficult;
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we may fail to obtain reimbursement approvals or pricing that is cost effective for patients as compared to other available forms of treatment or that covers the cost of production and other expenses;
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they may not compete effectively with existing or future alternatives;
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we may be unable to develop commercial operations and to sell marketing rights;
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they may fail to achieve market acceptance; or
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we may be precluded from commercialization of a product due to proprietary rights of third parties.
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obtain an annual renewal of our conditional marketing authorization for PIXUVRI;
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increase demand for and sales of PIXUVRI and obtain greater acceptance of PIXUVRI by physicians and patients;
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establish and maintain agreements with wholesalers and distributors on reasonable terms;
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maintain, and where necessary, enter into additional, commercial manufacturing arrangements with third parties, cost-effectively manufacture necessary quantities and secure distribution, managerial and other capabilities; and
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further develop and maintain a commercial organization to market PIXUVRI.
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In Europe, PIXUVRI faces competition from existing treatments for adults with multiply relapsed or refractory aggressive B-cell NHL. For example, patients are currently being treated with ibrutinib, idelalisib, lenolidimide,
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If we are successful in bringing pacritinib to market, pacritinib will face competition from the currently approved JAK1/JAK2 inhibitor, Jakafi
®
.
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•
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If we are successful in bringing tosedostat to market, we will face competition from currently marketed products, such as cytarabine, Dacogen
®
, Vidaza
®
, Clolar
®
, Revlimid
®
and Thalomid
®
.
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•
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announcements by us or others of results of clinical trials and regulatory actions, such as the imposition of a clinical trial hold;
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•
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announcements by us or others of serious adverse events that have occurred during administration of our products to patients;
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•
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announcements by us or others relating to our ongoing development and commercialization activities;
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halting or suspension of trading in our common stock on The NASDAQ Capital Market or on the MTA;
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•
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announcements of technological innovations or new commercial therapeutic products by us, our collaborative partners or our present or potential competitors;
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our issuance of debt or equity securities, which we expect to pursue to generate additional funds to operate our business, or any perception from time to time that we will issue such securities;
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•
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our quarterly operating results;
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•
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liquidity, cash position or financing needs;
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•
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developments or disputes concerning patent or other proprietary rights;
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•
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developments in relationships with collaborative partners;
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•
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acquisitions or divestitures;
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•
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our ability to realize the anticipated benefits of our compounds;
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•
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litigation and government proceedings;
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•
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adverse legislation, including changes in governmental regulation;
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•
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third party reimbursement policies;
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•
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changes in securities analysts’ recommendations;
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•
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short selling of our securities;
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•
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changes in health care policies and practices;
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•
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a failure to achieve previously announced goals and objectives as or when projected; and
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•
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general economic and market conditions.
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•
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elimination of cumulative voting in the election of directors;
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•
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procedures for advance notification of shareholder nominations and proposals;
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•
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the ability of our Board of Directors to amend our bylaws without shareholder approval; and
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•
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the ability of our Board of Directors to issue shares of preferred stock without shareholder approval upon the terms and conditions and with the rights, privileges and preferences as our Board of Directors may determine.
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•
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2003 VAT. In September 2011, the Provincial Tax Court issued decision no. 229/3/2011, which (i) fully accepted the merits of our appeal, (ii) declared that no penalties can be imposed against us, and (iii) found the ITA liable to pay us €10,000, as partial refund of the legal expenses we incurred for our appeal. In October 2012, the ITA appealed this decision. In June 2013, the Regional Tax Court issued decision no. 119/50/13, which accepted the appeal of the ITA and reversed the previous decision of the Provincial Tax Court. We believe that such decision has not carefully taken into account our arguments and the documentation we filed, and therefore appealed such decision in front of the Supreme Court both on procedural grounds and on the merits of the case in January 2014. In January 2014 the Company was provided a notice of payment with which the ITA requested the advance payment of €0.4 million of VAT, interest and penalties. We paid such amount in March 2014.
|
•
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2005 VAT. In January 2011, the Provincial Tax Court issued decision No. 4/2010 which (i) partially accepted our appeal and declared that no penalties can be imposed against us, (ii) confirmed the right of the ITA to reassess the VAT (plus interest) in relation to the transactions identified in the 2005 notice of assessment and (iii) repealed the suspension of the notice of deposit payment. Both the ITA and the Company appealed to the higher court against the decision. In October 2012, the Regional Tax Court issued a decision no. 127/31/2012, which (i) fully accepted the merits of our appeal and (ii) confirmed that no penalties can be imposed against us. In April 2013, the ITA appealed the decision to the Italian Supreme Court.
|
•
|
2006 VAT. In October 2011, the Provincial Tax Court issued decision no. 276/21/2011 (jointly with the 2007 VAT case) in which it (i) fully accepted the merits of our appeal, (ii) declared that no penalties can be imposed against us, and (iii) found that for the 2006 and 2007 VAT cases the ITA was liable to pay us €10,000 as partial refund of the legal expenses incurred for the appeal. In December 2011, the ITA appealed this decision to the Regional Tax Court. On April 16, 2013, the Regional Tax Court issued decision no. 57/35/13 (jointly with the 2007 VAT case) in which it fully rejected the merits of the ITA’s appeal, declared that no penalties can be imposed against us, and found the ITA liable to pay us €12,000, as partial refund of the legal expenses we incurred for this appeal. In November 2013, the ITA appealed the decision to the Supreme Court.
|
•
|
2007 VAT. In October 2011, the Provincial Tax Court issued decision no. 276/21/2011 (jointly with the 2006 VAT case described above) in which the Provincial Tax Court (i) fully accepted the merits of our appeal, (ii) declared that no penalties can be imposed against us, and (iii) found that for the 2006 and 2007 VAT cases the ITA was liable to pay us €10,000 as partial refund of the legal expenses incurred for the appeal. In December 2011, the ITA appealed this decision to the Regional Tax Court. On April 16, 2013, the Regional Tax Court issued decision no. 57/35/13 (jointly with the 2006 VAT case) in which it fully rejected the merits of the ITA’s appeal, declared that no penalties can be imposed against us, and found the ITA liable to pay us €12,000, as partial refund of the legal expenses we incurred for this appeal. In November 2013, the ITA appealed the decision to the Supreme Court.
|
|
High
|
|
Low
|
||||
2015
|
|
|
|
||||
First Quarter
|
$
|
29.40
|
|
|
$
|
17.70
|
|
Second Quarter
|
$
|
24.60
|
|
|
$
|
16.50
|
|
Third Quarter
|
$
|
20.80
|
|
|
$
|
13.80
|
|
Fourth Quarter
|
$
|
17.50
|
|
|
$
|
8.00
|
|
2016
|
|
|
|
||||
First Quarter
|
$
|
13.20
|
|
|
$
|
2.51
|
|
Second Quarter
|
$
|
5.80
|
|
|
$
|
3.07
|
|
Third Quarter
|
$
|
4.58
|
|
|
$
|
3.16
|
|
Fourth Quarter
|
$
|
5.80
|
|
|
$
|
3.60
|
|
Period
|
Total Number of Shares Purchased (1)
|
|
Average Price Paid per Share
|
|
Total Number
of Shares Purchased as Part of Publicly Announced Programs
|
|
Maximum Number of Shares that May Yet Be Purchased Under the Plans or Programs
|
|||||
October 1 – October 31, 2016
|
9,422
|
|
|
$
|
3.79
|
|
|
—
|
|
|
—
|
|
November 1 – November 30, 2016
|
896
|
|
|
$
|
3.97
|
|
|
—
|
|
|
—
|
|
December 1 – December 31, 2016
|
976
|
|
|
$
|
4.77
|
|
|
—
|
|
|
—
|
|
Total
|
11,294
|
|
|
$
|
3.89
|
|
|
—
|
|
|
—
|
|
(1)
|
Represents purchases of shares in connection with satisfying tax withholding obligations on the vesting of restricted stock awards to employees and not pursuant to a publicly announced plan or program.
|
|
12/31/2011
|
|
12/31/2012
|
|
12/31/2013
|
|
12/31/2014
|
|
12/31/2015
|
|
12/31/2016
|
||||||||||||
CTI BioPharma Corp.
|
$
|
100.00
|
|
|
$
|
22.41
|
|
|
$
|
32.93
|
|
|
$
|
40.69
|
|
|
$
|
21.21
|
|
|
$
|
7.03
|
|
NASDAQ Stock Index (U.S.)
|
$
|
100.00
|
|
|
$
|
116.43
|
|
|
$
|
155.41
|
|
|
$
|
174.78
|
|
|
$
|
175.62
|
|
|
$
|
198.47
|
|
NASDAQ Pharmaceutical Index
|
$
|
100.00
|
|
|
$
|
114.32
|
|
|
$
|
155.11
|
|
|
$
|
188.95
|
|
|
$
|
199.22
|
|
|
$
|
197.05
|
|
|
Year ended December 31,
|
||||||||||||||||||
|
2016
|
|
2015
|
|
2014
|
|
2013
|
|
2012
|
||||||||||
|
(In thousands, except per share data)
|
||||||||||||||||||
Consolidated Statements of Operations Data:
|
|
|
|
|
|
|
|
|
|
|
|||||||||
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|||||||||
Product sales, net(1)
|
$
|
4,331
|
|
|
$
|
3,496
|
|
|
$
|
6,917
|
|
|
$
|
2,314
|
|
|
$
|
—
|
|
License and contract revenue(2)
|
53,074
|
|
|
12,620
|
|
|
53,160
|
|
|
32,364
|
|
|
—
|
|
|||||
Total revenues
|
57,405
|
|
|
16,116
|
|
|
60,077
|
|
|
34,678
|
|
|
—
|
|
|||||
Operating costs and expenses, net:
|
|
|
|
|
|
|
|
|
|
||||||||||
Cost of product sold(1)
|
1,377
|
|
|
1,940
|
|
|
895
|
|
|
137
|
|
|
—
|
|
|||||
Research and development
|
64,961
|
|
|
76,627
|
|
|
64,596
|
|
|
33,624
|
|
|
33,201
|
|
|||||
Selling, general and administrative
|
45,306
|
|
|
53,962
|
|
|
56,241
|
|
|
42,443
|
|
|
39,188
|
|
|||||
Acquired in-process research and development(3)
|
—
|
|
|
—
|
|
|
21,859
|
|
|
—
|
|
|
29,108
|
|
|||||
Other operating expense (income), net
|
(5,077
|
)
|
|
253
|
|
|
2,719
|
|
|
—
|
|
|
—
|
|
|||||
Total operating costs and expenses, net
|
106,567
|
|
|
132,782
|
|
|
146,310
|
|
|
76,204
|
|
|
101,497
|
|
|||||
Loss from operations
|
(49,162
|
)
|
|
(116,666
|
)
|
|
(86,233
|
)
|
|
(41,526
|
)
|
|
(101,497
|
)
|
|||||
Non-operating income (expense):
|
|
|
|
|
|
|
|
|
|
||||||||||
Interest expense
|
(2,614
|
)
|
|
(2,104
|
)
|
|
(1,947
|
)
|
|
(1,026
|
)
|
|
(56
|
)
|
|||||
Amortization of debt discount and issuance costs
|
(214
|
)
|
|
(390
|
)
|
|
(729
|
)
|
|
(513
|
)
|
|
—
|
|
|||||
Foreign exchange gain (loss)
|
(484
|
)
|
|
(703
|
)
|
|
(4,435
|
)
|
|
61
|
|
|
344
|
|
|||||
Other non-operating expense
|
(479
|
)
|
|
(900
|
)
|
|
(885
|
)
|
|
(546
|
)
|
|
(478
|
)
|
|||||
Total non-operating expense, net
|
(3,791
|
)
|
|
(4,097
|
)
|
|
(7,996
|
)
|
|
(2,024
|
)
|
|
(190
|
)
|
|||||
Net loss before noncontrolling interest
|
(52,953
|
)
|
|
(120,763
|
)
|
|
(94,229
|
)
|
|
(43,550
|
)
|
|
(101,687
|
)
|
|||||
Noncontrolling interest
|
944
|
|
|
1,341
|
|
|
862
|
|
|
807
|
|
|
313
|
|
|||||
Net loss attributable to CTI
|
(52,009
|
)
|
|
(119,422
|
)
|
|
(93,367
|
)
|
|
(42,743
|
)
|
|
(101,374
|
)
|
|||||
Dividends and deemed dividends on preferred stock
|
—
|
|
|
(3,200
|
)
|
|
(2,625
|
)
|
|
(6,900
|
)
|
|
(13,901
|
)
|
|||||
Net loss attributable to common shareholders
|
$
|
(52,009
|
)
|
|
$
|
(122,622
|
)
|
|
$
|
(95,992
|
)
|
|
$
|
(49,643
|
)
|
|
$
|
(115,275
|
)
|
Basic and diluted net loss per common share(4)
|
$
|
(1.86
|
)
|
|
$
|
(6.51
|
)
|
|
$
|
(6.46
|
)
|
|
$
|
(4.35
|
)
|
|
$
|
(19.83
|
)
|
Shares used in calculation of basic and diluted net loss
per common share(4)
|
27,948
|
|
|
18,837
|
|
|
14,853
|
|
|
11,419
|
|
|
5,812
|
|
|
Year ended December 31,
|
||||||||||||||||||
|
2016
|
|
2015
|
|
2014
|
|
2013
|
|
2012
|
||||||||||
|
(In thousands)
|
||||||||||||||||||
Consolidated Balance Sheets Data:
|
|
|
|
|
|
|
|
|
|
|
|||||||||
Cash and cash equivalents
|
$
|
44,002
|
|
|
$
|
128,182
|
|
|
$
|
70,933
|
|
|
$
|
71,639
|
|
|
$
|
50,436
|
|
Working capital
|
15,178
|
|
|
62,566
|
|
|
44,165
|
|
|
60,446
|
|
|
37,644
|
|
|||||
Total assets
|
63,843
|
|
|
144,197
|
|
|
92,122
|
|
|
93,464
|
|
|
73,713
|
|
|||||
Current portion of long-term debt(5)
|
7,949
|
|
|
37,371
|
|
|
9,014
|
|
|
3,155
|
|
|
—
|
|
|||||
Long-term debt, less current portion(5)
|
11,311
|
|
|
19,124
|
|
|
8,198
|
|
|
9,893
|
|
|
—
|
|
|||||
Other liabilities
|
3,615
|
|
|
4,141
|
|
|
5,882
|
|
|
5,657
|
|
|
4,641
|
|
|||||
Common stock purchase warrants
|
—
|
|
|
—
|
|
|
1,445
|
|
|
13,461
|
|
|
13,461
|
|
|||||
Accumulated deficit
|
(2,150,326
|
)
|
|
(2,098,317
|
)
|
|
(1,975,695
|
)
|
|
(1,879,703
|
)
|
|
(1,830,060
|
)
|
|||||
Total shareholders’ equity
|
7,757
|
|
|
47,413
|
|
|
38,478
|
|
|
42,758
|
|
|
32,944
|
|
|
|
Years ended December 31,
|
||||||||||
|
|
2016
|
|
2015
|
|
2014
|
||||||
Baxalta
|
Milestone and license revenue
|
$
|
32,000
|
|
|
$
|
—
|
|
|
$
|
20,000
|
|
|
Development services revenue
|
12,437
|
|
|
815
|
|
|
853
|
|
|||
|
Total Baxalta
|
44,437
|
|
|
815
|
|
|
20,853
|
|
|||
|
|
|
|
|
|
|
||||||
Servier
|
Milestone and license revenue
|
7,998
|
|
|
1,702
|
|
|
17,277
|
|
|||
|
Development services revenue
|
639
|
|
|
103
|
|
|
30
|
|
|||
|
Total Servier
|
8,637
|
|
|
1,805
|
|
|
17,307
|
|
|||
|
|
|
|
|
|
|
||||||
Teva
|
Milestones revenue
|
—
|
|
|
10,000
|
|
|
15,000
|
|
|||
|
Total Teva
|
—
|
|
|
$
|
10,000
|
|
|
$
|
15,000
|
|
|
|
|
|
|
|
|
|
||||||
Total license and contract revenue
|
$
|
53,074
|
|
|
$
|
12,620
|
|
|
$
|
53,160
|
|
|
Years ended December 31,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
Compounds under development:
|
|
|
|
|
|
|
|||||
PIXUVRI
|
$
|
12,009
|
|
|
$
|
14,465
|
|
|
$
|
7,740
|
|
Pacritinib
|
32,150
|
|
|
36,152
|
|
|
34,140
|
|
|||
Opaxio
|
98
|
|
|
626
|
|
|
283
|
|
|||
Tosedostat
|
1,587
|
|
|
920
|
|
|
645
|
|
|||
Operating expenses
|
18,494
|
|
|
23,212
|
|
|
20,817
|
|
|||
Research and preclinical development
|
623
|
|
|
1,252
|
|
|
971
|
|
|||
Total research and development expenses
|
$
|
64,961
|
|
|
$
|
76,627
|
|
|
$
|
64,596
|
|
•
|
changes in manufacturing;
|
•
|
developments in and expenses associated with our research and development activities;
|
•
|
acquisitions of compounds or other assets;
|
•
|
ability to generate sales of PIXUVRI and any expansion of our sales and marketing organization for PIXUVRI;
|
•
|
regulatory approval developments;
|
•
|
ability to execute appropriate collaborations for development and commercialization activities;
|
•
|
ability to reach milestones triggering payments under certain of our contractual arrangements;
|
•
|
litigation and other disputes;
|
•
|
competitive market developments; and
|
•
|
other unplanned business developments.
|
Contractual Obligations
|
Payments Due by Period
|
||||||||||||||||||
|
Total
|
|
Less than
1 Year
|
|
1-3 Years
|
|
3-5 Years
|
|
More than
5 Years
|
||||||||||
Operating leases:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Facilities
|
$
|
13,614
|
|
|
$
|
2,579
|
|
|
$
|
4,976
|
|
|
$
|
5,177
|
|
|
$
|
882
|
|
Long-term debt (1)
|
19,548
|
|
|
8,049
|
|
|
11,499
|
|
|
—
|
|
|
—
|
|
|||||
Interest on long-term debt (1)
|
2,711
|
|
|
1,847
|
|
|
864
|
|
|
—
|
|
|
—
|
|
|||||
Purchase commitments (2) (3)
|
11,432
|
|
|
11,301
|
|
|
87
|
|
|
44
|
|
|
—
|
|
|||||
Other obligations (4)
|
5,752
|
|
|
5,005
|
|
|
747
|
|
|
—
|
|
|
—
|
|
|||||
|
$
|
53,057
|
|
|
$
|
28,781
|
|
|
$
|
18,173
|
|
|
$
|
5,221
|
|
|
$
|
882
|
|
(1)
|
The long-term debt amount includes the principal payable of $19.5 million under our senior secured term loan. The interest rate on our senior secured term loan floats at a rate per annum equal to 10.95% plus the amount by which the prime rate exceeds 3.25%. The amounts presented for interest payments in future periods assume a prime rate of 3.75%. See Part II, Item 8, "Financial Statements and Supplementary Data, Notes to Consolidated Financial Statements, Note
8. Long-term Debt
" for further details.
|
(2)
|
Purchase commitments include obligations related to manufacturing supply, insurance and other purchase commitments.
|
(3)
|
As a result of the Termination Agreement with Baxalta, $8.1 million of purchase commitments related to third party manufacturing of pacritinib product will remain our contractual purchase commitment.
|
(4)
|
Other obligations include $2.4 million in severance payments, the remaining contributions we have agreed to make under certain endowment agreements in the aggregate amount of $2.3 million and a $0.8 million expense payable to Novartis as a result of a certain enrollment event achieved in December 2016 under the Servier Agreement. Other obligations do not include $3.5 million in deferred rent associated with our operating lease for office space.
|
|
Page
|
|
December 31, 2016
|
|
December 31, 2015
|
||||
ASSETS
|
|
|
|
|
|||
Current assets:
|
|
|
|
|
|||
Cash and cash equivalents
|
$
|
44,002
|
|
|
$
|
128,182
|
|
Accounts receivable
|
378
|
|
|
282
|
|
||
Receivable from collaborative arrangement
|
7,778
|
|
|
—
|
|
||
Inventory, net
|
1,525
|
|
|
2,845
|
|
||
Prepaid expenses and other current assets
|
2,141
|
|
|
3,666
|
|
||
Total current assets
|
55,824
|
|
|
134,975
|
|
||
Property and equipment, net
|
3,023
|
|
|
3,718
|
|
||
Other assets
|
4,996
|
|
|
5,504
|
|
||
Total assets
|
$
|
63,843
|
|
|
$
|
144,197
|
|
|
|
|
|
||||
LIABILITIES AND SHAREHOLDERS' EQUITY
|
|
|
|
|
|||
Current liabilities:
|
|
|
|
|
|||
Accounts payable
|
$
|
7,227
|
|
|
$
|
10,584
|
|
Accrued expenses
|
24,765
|
|
|
22,133
|
|
||
Current portion of deferred revenue
|
103
|
|
|
578
|
|
||
Current portion of long-term debt
|
7,949
|
|
|
37,371
|
|
||
Other current liabilities
|
602
|
|
|
1,743
|
|
||
Total current liabilities
|
40,646
|
|
|
72,409
|
|
||
Deferred revenue, less current portion
|
514
|
|
|
1,110
|
|
||
Long-term debt, less current portion
|
11,311
|
|
|
19,124
|
|
||
Other liabilities
|
3,615
|
|
|
4,141
|
|
||
Total liabilities
|
56,086
|
|
|
96,784
|
|
||
Commitments and contingencies
|
|
|
|
|
|||
Shareholders' equity:
|
|
|
|
|
|||
Common stock, no par value:
|
|
|
|
|
|||
Authorized shares - 41,500,000 and 31,500,000 at December 31, 2016 and 2015, respectively
|
|
|
|
|
|||
Issued and outstanding shares - 28,228,602 and 28,046,109 at
December 31, 2016 and 2015, respectively
|
2,170,300
|
|
|
2,157,300
|
|
||
Accumulated other comprehensive loss
|
(6,655
|
)
|
|
(6,952
|
)
|
||
Accumulated deficit
|
(2,150,326
|
)
|
|
(2,098,317
|
)
|
||
Total CTI shareholders' equity
|
13,319
|
|
|
52,031
|
|
||
Noncontrolling interest
|
(5,562
|
)
|
|
(4,618
|
)
|
||
Total shareholders' equity
|
7,757
|
|
|
47,413
|
|
||
Total liabilities and shareholders' equity
|
$
|
63,843
|
|
|
$
|
144,197
|
|
|
Year Ended December 31,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
Revenues:
|
|
|
|
|
|
||||||
Product sales, net
|
$
|
4,331
|
|
|
$
|
3,496
|
|
|
$
|
6,917
|
|
License and contract revenue
|
53,074
|
|
|
12,620
|
|
|
53,160
|
|
|||
Total revenues
|
57,405
|
|
|
16,116
|
|
|
60,077
|
|
|||
Operating costs and expenses:
|
|
|
|
|
|
|
|
|
|||
Cost of product sold
|
1,377
|
|
|
1,940
|
|
|
895
|
|
|||
Research and development
|
64,961
|
|
|
76,627
|
|
|
64,596
|
|
|||
Selling, general and administrative
|
45,306
|
|
|
53,962
|
|
|
56,241
|
|
|||
Acquired in-process research and development
|
—
|
|
|
—
|
|
|
21,859
|
|
|||
Other operating (income) expense, net
|
(5,077
|
)
|
|
253
|
|
|
2,719
|
|
|||
Total operating costs and expenses, net
|
106,567
|
|
|
132,782
|
|
|
146,310
|
|
|||
Loss from operations
|
(49,162
|
)
|
|
(116,666
|
)
|
|
(86,233
|
)
|
|||
Non-operating expense:
|
|
|
|
|
|
|
|
|
|||
Interest expense
|
(2,614
|
)
|
|
(2,104
|
)
|
|
(1,947
|
)
|
|||
Amortization of debt discount and issuance costs
|
(214
|
)
|
|
(390
|
)
|
|
(729
|
)
|
|||
Foreign exchange loss
|
(484
|
)
|
|
(703
|
)
|
|
(4,435
|
)
|
|||
Other non-operating expense
|
(479
|
)
|
|
(900
|
)
|
|
(885
|
)
|
|||
Total non-operating expense
|
(3,791
|
)
|
|
(4,097
|
)
|
|
(7,996
|
)
|
|||
Net loss before noncontrolling interest
|
(52,953
|
)
|
|
(120,763
|
)
|
|
(94,229
|
)
|
|||
Noncontrolling interest
|
944
|
|
|
1,341
|
|
|
862
|
|
|||
Net loss attributable to CTI
|
(52,009
|
)
|
|
(119,422
|
)
|
|
(93,367
|
)
|
|||
Deemed dividends on preferred stock
|
—
|
|
|
(3,200
|
)
|
|
(2,625
|
)
|
|||
Net loss attributable to common shareholders
|
$
|
(52,009
|
)
|
|
$
|
(122,622
|
)
|
|
$
|
(95,992
|
)
|
Basic and diluted net loss per common share
|
$
|
(1.86
|
)
|
|
$
|
(6.51
|
)
|
|
$
|
(6.46
|
)
|
Shares used in calculation of basic and diluted net loss per
common share
|
27,948
|
|
|
18,837
|
|
|
14,853
|
|
|
Year Ended December 31,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
Net loss before noncontrolling interest
|
$
|
(52,953
|
)
|
|
$
|
(120,763
|
)
|
|
$
|
(94,229
|
)
|
Other comprehensive income (loss):
|
|
|
|
|
|
|
|
|
|||
Foreign currency translation adjustments
|
947
|
|
|
2,160
|
|
|
1,998
|
|
|||
Unrealized foreign exchange loss on intercompany balance
|
(1,162
|
)
|
|
(2,585
|
)
|
|
—
|
|
|||
Other-than-temporary impairment on available-for-sale securities
|
520
|
|
|
—
|
|
|
—
|
|
|||
Net unrealized loss on securities available-for-sale
|
(8
|
)
|
|
(28
|
)
|
|
(68
|
)
|
|||
Other comprehensive income (loss)
|
297
|
|
|
(453
|
)
|
|
1,930
|
|
|||
Comprehensive loss
|
(52,656
|
)
|
|
(121,216
|
)
|
|
(92,299
|
)
|
|||
Comprehensive loss attributable to noncontrolling interest
|
944
|
|
|
1,341
|
|
|
862
|
|
|||
Comprehensive loss attributable to CTI
|
$
|
(51,712
|
)
|
|
$
|
(119,875
|
)
|
|
$
|
(91,437
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other
|
|
|
|
Total
|
||||||||
|
Preferred Stock
|
|
Common Stock
|
|
Accumulated
|
|
Comprehensive
|
|
Noncontrolling
|
|
Shareholders'
|
||||||||||||
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
Deficit
|
|
Income (Loss)
|
|
Interest
|
|
Equity
|
||||||||
Balance at December 31, 2013
|
—
|
|
|
—
|
|
|
14,551
|
|
|
1,933,305
|
|
|
(1,879,703
|
)
|
|
(8,429
|
)
|
|
(2,415
|
)
|
|
42,758
|
|
Issuance of Series 20 preferred stock,
net of issuance costs |
9
|
|
|
21,486
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
21,486
|
|
Conversion of Series 20 preferred stock
to common stock |
(9
|
)
|
|
(21,486
|
)
|
|
900
|
|
|
21,486
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Issuance of Series 21 preferred stock,
net of issuance costs |
35
|
|
|
32,342
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
32,342
|
|
Conversion of Series 21 preferred stock
to common stock |
(35
|
)
|
|
(32,342
|
)
|
|
1,750
|
|
|
32,342
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Value of beneficial conversion features
related to preferred stock |
—
|
|
|
—
|
|
|
—
|
|
|
2,625
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2,625
|
|
Exercise of common stock purchase warrants
|
—
|
|
|
—
|
|
|
49
|
|
|
1,877
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,877
|
|
Equity-based compensation
|
—
|
|
|
—
|
|
|
413
|
|
|
20,196
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
20,196
|
|
Stock option exercises
|
—
|
|
|
—
|
|
|
18
|
|
|
272
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
272
|
|
Noncontrolling interest
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(862
|
)
|
|
(862
|
)
|
Expiry of mezzanine equity
|
—
|
|
|
—
|
|
|
—
|
|
|
12,016
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
12,016
|
|
Other
|
—
|
|
|
—
|
|
|
(5
|
)
|
|
(170
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(170
|
)
|
Deemed dividends on preferred stock
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(2,625
|
)
|
|
—
|
|
|
—
|
|
|
(2,625
|
)
|
Net loss for the year ended December 31, 2014
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(93,367
|
)
|
|
—
|
|
|
—
|
|
|
(93,367
|
)
|
Other comprehensive income
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,930
|
|
|
—
|
|
|
1,930
|
|
Balance at December 31, 2014
|
—
|
|
|
—
|
|
|
17,676
|
|
|
2,023,949
|
|
|
(1,975,695
|
)
|
|
(6,499
|
)
|
|
(3,277
|
)
|
|
38,478
|
|
Issuance of common stock, net of
issuance costs |
—
|
|
|
—
|
|
|
1,000
|
|
|
15,147
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
15,147
|
|
Issuance of Series N-1 preferred stock,
net of issuance costs |
50
|
|
|
46,611
|
|
|
|
|
|
|
|
|
|
|
|
|
46,611
|
|
|||||
Conversion of Series N-1 preferred
stock to common stock |
(50
|
)
|
|
(46,611
|
)
|
|
4,000
|
|
|
46,611
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Value of beneficial conversion features related to preferred stock
|
—
|
|
|
—
|
|
|
—
|
|
|
3,200
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
3,200
|
|
Issuance of Series N-2 preferred stock,
net of issuance costs |
55
|
|
|
52,409
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
52,409
|
|
Conversion of Series N-2 preferred
stock to common stock |
(55
|
)
|
|
(52,409
|
)
|
|
5,000
|
|
|
52,409
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Expiry of exercise price provision
features related to common stock purchase warrant |
—
|
|
|
—
|
|
|
—
|
|
|
150
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
150
|
|
Equity-based compensation
|
—
|
|
|
—
|
|
|
393
|
|
|
14,828
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
14,828
|
|
Stock option exercises
|
—
|
|
|
—
|
|
|
8
|
|
|
156
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
156
|
|
Noncontrolling interest
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(1,341
|
)
|
|
(1,341
|
)
|
Expiry of mezzanine equity
|
—
|
|
|
—
|
|
|
—
|
|
|
1,445
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,445
|
|
Other
|
—
|
|
|
—
|
|
|
(31
|
)
|
|
(595
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(595
|
)
|
Deemed dividends on preferred stock
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(3,200
|
)
|
|
—
|
|
|
—
|
|
|
(3,200
|
)
|
Net loss for the year ended December 31, 2015
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(119,422
|
)
|
|
—
|
|
|
—
|
|
|
(119,422
|
)
|
Other comprehensive loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(453
|
)
|
|
—
|
|
|
(453
|
)
|
Balance at December 31, 2015
|
—
|
|
|
—
|
|
|
28,046
|
|
|
2,157,300
|
|
|
(2,098,317
|
)
|
|
(6,952
|
)
|
|
(4,618
|
)
|
|
47,413
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other
|
|
|
|
Total
|
||||||||
|
Preferred Stock
|
|
Common Stock
|
|
Accumulated
|
|
Comprehensive
|
|
Noncontrolling
|
|
Shareholders'
|
||||||||||||
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
Deficit
|
|
Income (Loss)
|
|
Interest
|
|
Equity
|
||||||||
Equity-based compensation
|
—
|
|
|
—
|
|
|
207
|
|
|
13,324
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
13,324
|
|
Noncontrolling interest
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(944
|
)
|
|
(944
|
)
|
Other
|
—
|
|
|
—
|
|
|
(24
|
)
|
|
(324
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(324
|
)
|
Net loss for the year ended December 31, 2016
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(52,009
|
)
|
|
—
|
|
|
—
|
|
|
(52,009
|
)
|
Other comprehensive income
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
297
|
|
|
—
|
|
|
297
|
|
Balance at December 31, 2016
|
—
|
|
|
—
|
|
|
28,229
|
|
|
2,170,300
|
|
|
(2,150,326
|
)
|
|
(6,655
|
)
|
|
(5,562
|
)
|
|
7,757
|
|
|
Year Ended December 31,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
Operating activities
|
|
|
|
|
|
|
|
|
|||
Net loss
|
$
|
(52,953
|
)
|
|
$
|
(120,763
|
)
|
|
$
|
(94,229
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
|
|
|
|||
Baxalta milestone revenue
|
(32,000
|
)
|
|
—
|
|
|
—
|
|
|||
Acquired in-process research and development
|
—
|
|
|
—
|
|
|
21,859
|
|
|||
Share-based compensation expense
|
13,324
|
|
|
14,828
|
|
|
20,196
|
|
|||
Depreciation and amortization
|
831
|
|
|
990
|
|
|
1,100
|
|
|||
Loss on debt extinguishment
|
—
|
|
|
1,211
|
|
|
—
|
|
|||
Provision for bad debts
|
1,735
|
|
|
—
|
|
|
—
|
|
|||
Reserve for excess, obsolete or unsalable inventory
|
692
|
|
|
1,326
|
|
|
—
|
|
|||
Other-than-temporary impairment on available-for-sale securities
|
520
|
|
|
—
|
|
|
—
|
|
|||
Noncash interest expense
|
214
|
|
|
390
|
|
|
729
|
|
|||
Noncash rent benefit
|
(467
|
)
|
|
(409
|
)
|
|
(354
|
)
|
|||
Change in value of warrant liability
|
—
|
|
|
(232
|
)
|
|
886
|
|
|||
Provision for VAT Assessments
|
—
|
|
|
—
|
|
|
600
|
|
|||
Other
|
—
|
|
|
—
|
|
|
(20
|
)
|
|||
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
|||
Accounts receivable
|
(156
|
)
|
|
1,555
|
|
|
(1,980
|
)
|
|||
Receivables from collaborative arrangements
|
(9,476
|
)
|
|
—
|
|
|
—
|
|
|||
Inventory
|
567
|
|
|
(402
|
)
|
|
305
|
|
|||
Prepaid expenses and other current assets
|
1,609
|
|
|
(402
|
)
|
|
46
|
|
|||
Other assets
|
355
|
|
|
826
|
|
|
(356
|
)
|
|||
Accounts payable
|
(3,025
|
)
|
|
4,368
|
|
|
1,454
|
|
|||
Accrued expenses
|
2,620
|
|
|
2,426
|
|
|
10,250
|
|
|||
Deferred revenue
|
(1,071
|
)
|
|
(918
|
)
|
|
(31
|
)
|
|||
Other liabilities
|
1
|
|
|
3
|
|
|
(5
|
)
|
|||
Total adjustments
|
(23,727
|
)
|
|
25,560
|
|
|
54,679
|
|
|||
Net cash used in operating activities
|
(76,680
|
)
|
|
(95,203
|
)
|
|
(39,550
|
)
|
|||
Investing activities
|
|
|
|
|
|
|
|
|
|||
Purchases of property and equipment
|
(137
|
)
|
|
(78
|
)
|
|
(333
|
)
|
|||
Other
|
—
|
|
|
—
|
|
|
(208
|
)
|
|||
Net cash used in investing activities
|
(137
|
)
|
|
(78
|
)
|
|
(541
|
)
|
|||
Financing activities
|
|
|
|
|
|
|
|
|
|||
Proceeds from issuance of Series 19 preferred stock, net of issuance costs
|
—
|
|
|
—
|
|
|
(28
|
)
|
|||
Cash paid for Series 20 preferred stock issuance costs
|
—
|
|
|
—
|
|
|
(106
|
)
|
|||
Proceeds from issuance of Series 21 preferred stock, net of issuance costs
|
—
|
|
|
(227
|
)
|
|
32,621
|
|
|||
Proceeds from common stock offering, net of issuance costs
|
—
|
|
|
15,147
|
|
|
—
|
|
|||
Proceeds from issuance of Series N-1 preferred stock, net of issuance costs
|
(37
|
)
|
|
46,653
|
|
|
—
|
|
|||
Proceeds from issuance of Series N-2 preferred stock, net of issuance costs
|
(277
|
)
|
|
52,800
|
|
|
—
|
|
|||
Proceeds from Baxalta milestone advance, net of issuance costs
|
—
|
|
|
31,922
|
|
|
—
|
|
|||
Proceeds from Hercules debt, net of issuance costs
|
—
|
|
|
10,820
|
|
|
4,963
|
|
|||
Repayment of Hercules debt
|
(5,452
|
)
|
|
(4,659
|
)
|
|
(1,526
|
)
|
|||
Payment of a Hercules fee
|
(1,275
|
)
|
|
—
|
|
|
—
|
|
|||
Payment of tax withholding obligations related to stock compensation
|
(355
|
)
|
|
(604
|
)
|
|
(178
|
)
|
|||
Other
|
30
|
|
|
165
|
|
|
280
|
|
|||
Net cash (used in) provided by financing activities
|
(7,366
|
)
|
|
152,017
|
|
|
36,026
|
|
|||
Effect of exchange rate changes on cash and cash equivalents
|
3
|
|
|
513
|
|
|
3,359
|
|
|||
Net (decrease) increase in cash and cash equivalents
|
(84,180
|
)
|
|
57,249
|
|
|
(706
|
)
|
|||
Cash and cash equivalents at beginning of year
|
128,182
|
|
|
70,933
|
|
|
71,639
|
|
|||
Cash and cash equivalents at end of year
|
$
|
44,002
|
|
|
$
|
128,182
|
|
|
$
|
70,933
|
|
|
Year Ended December 31,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
Supplemental disclosure of cash flow information
|
|
|
|
|
|
|
|
|
|||
Cash paid during the period for interest
|
$
|
4,446
|
|
|
$
|
2,067
|
|
|
$
|
1,894
|
|
|
|
|
|
|
|
||||||
Supplemental disclosure of noncash financing and investing activities
|
|
|
|
|
|
|
|
|
|||
Conversion of Series 20 preferred stock to common stock
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
21,486
|
|
Conversion of Series 21 preferred stock to common stock
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
32,342
|
|
Issuance of Series 20 preferred stock for acquisition of assets from Chroma
Therapeutics Limited |
$
|
—
|
|
|
$
|
—
|
|
|
$
|
21,600
|
|
Conversion of Series N-1 preferred stock to common stock
|
$
|
—
|
|
|
$
|
46,611
|
|
|
$
|
—
|
|
Conversion of Series N-2 preferred stock to common stock
|
$
|
—
|
|
|
$
|
52,409
|
|
|
$
|
—
|
|
Issuance of common stock upon exercise or exchange of common stock purchase
warrants |
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,877
|
|
Repayment and issuance of Hercules debt
|
$
|
—
|
|
|
$
|
13,815
|
|
|
$
|
—
|
|
Baxalta milestone advance - earned in lieu of repayment
|
$
|
(32,000
|
)
|
|
$
|
—
|
|
|
$
|
—
|
|
|
2016
|
|
2015
|
||||
Finished goods
|
$
|
477
|
|
|
$
|
724
|
|
Work-in-process
|
2,558
|
|
|
3,386
|
|
||
Inventory, gross
|
$
|
3,035
|
|
|
$
|
4,110
|
|
Reserve for excess, obsolete or unsalable inventory
|
$
|
(1,510
|
)
|
|
$
|
(1,265
|
)
|
Inventory, net
|
$
|
1,525
|
|
|
$
|
2,845
|
|
|
2016
|
|
2015
|
||||
Furniture and office equipment
|
$
|
6,521
|
|
|
$
|
6,484
|
|
Leasehold improvements
|
5,106
|
|
|
5,078
|
|
||
Lab equipment
|
201
|
|
|
203
|
|
||
|
11,828
|
|
|
11,765
|
|
||
Less: accumulated depreciation and amortization
|
(8,805
|
)
|
|
(8,047
|
)
|
||
Property and equipment, net
|
$
|
3,023
|
|
|
$
|
3,718
|
|
Fair value of Series 20 Preferred Stock
|
$
|
21,600
|
|
Transaction costs
|
259
|
|
|
Total initial purchase consideration
|
$
|
21,859
|
|
|
2016
|
|
2015
|
||||
Clinical and investigator-sponsored trial expenses
|
$
|
7,303
|
|
|
$
|
8,976
|
|
Employee compensation and related expenses
|
6,364
|
|
|
5,498
|
|
||
Manufacturing expenses
|
7,616
|
|
|
921
|
|
||
Legal expenses
|
1,037
|
|
|
1,274
|
|
||
Accrued selling expenses
|
136
|
|
|
1,697
|
|
||
Insurance financing
|
888
|
|
|
679
|
|
||
Accrued interest expenses
|
2
|
|
|
1,817
|
|
||
Other
|
1,419
|
|
|
1,271
|
|
||
Total accrued expenses
|
$
|
24,765
|
|
|
$
|
22,133
|
|
|
Operating
|
||
|
Leases
|
||
2017
|
$
|
2,579
|
|
2018
|
2,486
|
|
|
2019
|
2,490
|
|
|
2020
|
2,555
|
|
|
2021
|
2,622
|
|
|
Thereafter
|
882
|
|
|
Total minimum lease commitments
|
$
|
13,614
|
|
|
2016
|
|
2015
|
||||
Deferred rent, less current portion
|
$
|
3,011
|
|
|
$
|
3,538
|
|
Other long-term obligations
|
604
|
|
|
603
|
|
||
Total other liabilities
|
$
|
3,615
|
|
|
$
|
4,141
|
|
Equity incentive plans
|
4,070
|
|
Common stock purchase warrants
|
29
|
|
Employee stock purchase plan
|
187
|
|
Total common stock reserved
|
4,286
|
|
|
Net Unrealized
Gain (Loss) and Impairment on
Available-For-Sale Securities
|
|
Foreign
Currency
Translation
Adjustments
|
|
Unrealized Foreign Exchange Loss on Intercompany Balance
|
|
Accumulated
Other
Comprehensive
Loss
|
||||||||
December 31, 2015
|
$
|
(518
|
)
|
|
$
|
(3,849
|
)
|
|
$
|
(2,585
|
)
|
|
$
|
(6,952
|
)
|
Current period other comprehensive income (loss)
|
512
|
|
|
947
|
|
|
(1,162
|
)
|
|
297
|
|
||||
December 31, 2016
|
$
|
(6
|
)
|
|
$
|
(2,902
|
)
|
|
$
|
(3,747
|
)
|
|
$
|
(6,655
|
)
|
•
|
a license from the Company to develop and commercialize pacritinib worldwide (subject to certain co-promotion rights of the Company in the U.S.); and
|
•
|
development services provided by the Company related to jointly agreed-upon development activities with cost sharing as discussed above.
|
•
|
a license with respect to the development and commercialization of PIXUVRI in certain countries; and
|
•
|
development services under the development plans.
|
License
|
$
|
17,277
|
|
Development and other services
|
852
|
|
|
Total upfront payment
|
$
|
18,129
|
|
|
2016
|
|
2015
|
|
2014
|
||||||
Performance rights
|
$
|
575
|
|
|
$
|
3,017
|
|
|
$
|
1,549
|
|
Restricted stock
|
4,199
|
|
|
8,656
|
|
|
14,749
|
|
|||
Options
|
8,550
|
|
|
3,155
|
|
|
3,898
|
|
|||
Total share-based compensation expense
|
$
|
13,324
|
|
|
$
|
14,828
|
|
|
$
|
20,196
|
|
|
2016
|
|
2015
|
|
2014
|
||||||
Research and development
|
$
|
2,320
|
|
|
$
|
3,964
|
|
|
$
|
3,437
|
|
Selling, general and administrative
|
11,004
|
|
|
10,864
|
|
|
16,759
|
|
|||
Total share-based compensation expense
|
$
|
13,324
|
|
|
$
|
14,828
|
|
|
$
|
20,196
|
|
|
Year Ended December 31,
|
|||||||
|
2016
|
|
2015
|
|
2014
|
|||
Risk-free interest rate
|
1.2
|
%
|
|
1.7
|
%
|
|
1.7
|
%
|
Expected dividend yield
|
None
|
|
|
None
|
|
|
None
|
|
Expected life (in years)
|
4.0
|
|
|
5.3
|
|
|
5.2
|
|
Volatility
|
75
|
%
|
|
80
|
%
|
|
97
|
%
|
|
Options
|
|
Weighted
Average
Exercise
Price
|
|
Weighted
Average
Remaining
Contractual
Term (Years)
|
|
Aggregate
Intrinsic
Value
(Thousands)
|
|||||
Outstanding at December 31, 2013 (156,000 exercisable)
|
452,000
|
|
|
$
|
30.40
|
|
|
|
|
|
|
|
Granted
|
102,000
|
|
|
$
|
34.85
|
|
|
|
|
|
|
|
Exercised
|
(18,000
|
)
|
|
$
|
14.89
|
|
|
|
|
|
|
|
Forfeited
|
(36,000
|
)
|
|
$
|
22.53
|
|
|
|
|
|
|
|
Cancelled and expired
|
(8,000
|
)
|
|
$
|
98.63
|
|
|
|
|
|
|
|
Outstanding at December 31, 2014 (317,400 exercisable)
|
492,000
|
|
|
$
|
31.39
|
|
|
|
|
|
|
|
Granted
|
1,149,000
|
|
|
$
|
13.94
|
|
|
|
|
|
|
|
Exercised
|
(8,000
|
)
|
|
$
|
13.98
|
|
|
|
|
|
|
|
Forfeited
|
(62,000
|
)
|
|
$
|
21.70
|
|
|
|
|
|
|
|
Cancelled and expired
|
(12,000
|
)
|
|
$
|
242.92
|
|
|
|
|
|
|
|
Outstanding at December 31, 2015 (436,100 exercisable)
|
1,559,000
|
|
|
$
|
17.45
|
|
|
|
|
|
|
|
Granted
|
1,511,000
|
|
|
$
|
6.43
|
|
|
|
|
|
|
|
Exercised
|
—
|
|
|
$
|
—
|
|
|
|
|
|
|
|
Forfeited
|
(128,000
|
)
|
|
$
|
9.07
|
|
|
|
|
|
|
|
Cancelled and expired
|
(136,000
|
)
|
|
$
|
25.58
|
|
|
|
|
|
|
|
Outstanding at December 31, 2016
|
2,806,000
|
|
|
$
|
11.50
|
|
|
5.3
|
|
$
|
153
|
|
Vested or expected to vest at December 31, 2016
|
2,749,000
|
|
|
$
|
11.58
|
|
|
5.3
|
|
$
|
153
|
|
Exercisable at December 31, 2016
|
1,913,000
|
|
|
$
|
12.58
|
|
|
3.6
|
|
$
|
151
|
|
|
Nonvested Shares
|
|
Weighted Average
Grant-Date Fair Value
Per Share
|
|||
Nonvested at December 31, 2015
|
267,000
|
|
|
$
|
22.39
|
|
Issued
|
270,000
|
|
|
$
|
5.64
|
|
Vested
|
(257,000
|
)
|
|
$
|
15.02
|
|
Forfeited
|
(97,000
|
)
|
|
$
|
13.38
|
|
Nonvested at December 31, 2016
|
183,000
|
|
|
$
|
12.76
|
|
|
Nonvested Units
|
|
Weighted Average
Grant-Date Fair Value Per Unit |
|||
Nonvested at December 31, 2015
|
33,000
|
|
|
$
|
15.70
|
|
Issued
|
187,000
|
|
|
$
|
5.35
|
|
Vested
|
(33,000
|
)
|
|
$
|
15.70
|
|
Forfeited
|
—
|
|
|
$
|
—
|
|
Nonvested at December 31, 2016
|
187,000
|
|
|
$
|
5.35
|
|
|
Year Ended December 31,
|
||||||
|
2016
|
|
2015
|
||||
United States
|
$
|
2,990
|
|
|
$
|
3,657
|
|
Europe
|
33
|
|
|
61
|
|
||
Total long-lived assets
|
$
|
3,023
|
|
|
$
|
3,718
|
|
|
Year Ended December 31,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
Net loss attributable to common shareholders
|
$
|
(52,009
|
)
|
|
$
|
(122,622
|
)
|
|
$
|
(95,992
|
)
|
Basic and diluted:
|
|
|
|
|
|
|
|||||
Weighted average shares outstanding
|
28,198
|
|
|
19,324
|
|
|
15,347
|
|
|||
Less weighted average restricted shares outstanding
|
(250
|
)
|
|
(487
|
)
|
|
(494
|
)
|
|||
Shares used in calculation of basic and diluted net loss per common share
|
27,948
|
|
|
18,837
|
|
|
14,853
|
|
|||
Net loss per common share: Basic and diluted
|
$
|
(1.86
|
)
|
|
$
|
(6.51
|
)
|
|
$
|
(6.46
|
)
|
•
|
We will cancel, and the non-employee directors will agree to, the rescission of all currently outstanding equity awards that we previously granted to non-employee directors that included performance-based vesting metrics and as to which the performance goals remained unsatisfied as of May 13, 2015;
|
•
|
Our current non-employee directors will agree to hold (not transfer or sell or encumber in any way) until September 14, 2015 shares of our stock that they currently own and that we awarded to them during 2011, or at any time after 2011 to the present, and that, at the time of the award by us, was fully-vested and unrestricted;
|
•
|
We will cap the total annual compensation provided by it to its non-employee directors for each of 2015 and 2016.
Such annual compensation cap for each non-employee director for each of 2015 and 2016 will be at the greater of (i)
$375,000
, plus, as to our Board Chairman, an additional
$100,000
, or (ii) the 75th percentile of compensation paid by a group of peer companies to their non-employee directors (and, in the case of our Chairman, the 75th percentile of compensation paid by such peers who have a non-employee director chair of their respective board of directors to such non-employee director chairs). The peer group for these purposes will be selected based on advice from the outside compensation consultant. For purposes of the compensation cap and the peer group comparison, compensation will be determined and measured
consistent with the rules under Item 402 of Regulation S-K under the Securities Exchange Act of 1934, as amended, and based on publicly-available information at the applicable time
; and
|
•
|
We will implement, if not already implemented, within 90 days following final approval of the Settlement by the court, and maintain until at least the end of calendar year 2017 the following: an annual board discussion of non-employee director compensation philosophy; the use of a compensation consultant to advise the Compensation Committee on material decisions concerning non-employee director compensation issues and compare our non-employee director compensation program to a group of our peers; the use of plain language in our compensation-related public filings; and
obtain
confirmation from our legal department and outside legal counsel advising on executive compensation matters that any contemplated non-employee director awards do not materially violate the applicable plan or materially fail to comply with applicable law.
|
|
2016
|
|
2015
|
|
2014
|
||||||
United States
|
$
|
(51,856
|
)
|
|
$
|
(110,831
|
)
|
|
$
|
(84,883
|
)
|
Foreign
|
(1,097
|
)
|
|
(9,932
|
)
|
|
(9,346
|
)
|
|||
Net loss before income taxes
|
$
|
(52,953
|
)
|
|
$
|
(120,763
|
)
|
|
$
|
(94,229
|
)
|
|
2016
|
|
2015
|
|
2014
|
|||
Federal income tax rate
|
34
|
%
|
|
34
|
%
|
|
34
|
%
|
Research and development tax credits
|
1
|
|
|
3
|
|
|
3
|
|
Non-deductible executive compensation
|
—
|
|
|
(1
|
)
|
|
(3
|
)
|
Valuation allowance
|
(33
|
)
|
|
(32
|
)
|
|
(30
|
)
|
Foreign tax rate differential
|
—
|
|
|
(3
|
)
|
|
(3
|
)
|
Other
|
(2
|
)
|
|
(1
|
)
|
|
(1
|
)
|
Net effective tax rate
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|
December 31,
|
||||||
|
2016
|
|
2015
|
||||
Deferred tax assets:
|
|
|
|
|
|
||
Net operating loss carryforwards
|
$
|
108,372
|
|
|
$
|
94,024
|
|
Capitalized research and development
|
43,768
|
|
|
39,537
|
|
||
Research and development tax credit carryforwards
|
7,253
|
|
|
6,685
|
|
||
Stock-based compensation
|
19,288
|
|
|
15,242
|
|
||
Intangible assets
|
14,525
|
|
|
15,694
|
|
||
Depreciation and amortization
|
626
|
|
|
260
|
|
||
Other deferred tax assets
|
3,721
|
|
|
3,180
|
|
||
Total deferred tax assets
|
197,553
|
|
|
174,622
|
|
||
Less: valuation allowance
|
(197,131
|
)
|
|
(173,947
|
)
|
||
|
422
|
|
|
675
|
|
||
Deferred tax liabilities:
|
|
|
|
|
|
||
GAAP adjustments on Novuspharma merger
|
—
|
|
|
(208
|
)
|
||
Deductions for tax in excess of financial statements
|
(422
|
)
|
|
(467
|
)
|
||
Total deferred tax liabilities
|
(422
|
)
|
|
(675
|
)
|
||
Net deferred tax assets
|
$
|
—
|
|
|
$
|
—
|
|
|
First
Quarter
|
|
Second
Quarter
|
|
Third
Quarter
|
|
Fourth
Quarter
|
||||||||
2016
|
|
|
|
|
|
|
|
||||||||
Total revenues (1)
|
$
|
36,475
|
|
|
$
|
7,361
|
|
|
$
|
4,433
|
|
|
$
|
9,136
|
|
Product sales, net
|
1,223
|
|
|
1,051
|
|
|
986
|
|
|
1,071
|
|
||||
Gross profit (2)
|
1,033
|
|
|
891
|
|
|
823
|
|
|
207
|
|
||||
Net income (loss) attributable to CTI
|
3,312
|
|
|
(19,766
|
)
|
|
(29,183
|
)
|
|
(6,372
|
)
|
||||
Net income (loss) attributable to CTI common shareholders
|
3,312
|
|
|
(19,766
|
)
|
|
(29,183
|
)
|
|
(6,372
|
)
|
||||
Net income (loss) per common share—basic
|
0.12
|
|
|
(0.71
|
)
|
|
(1.04
|
)
|
|
(0.23
|
)
|
||||
Net income (loss) per common share—diluted
|
0.12
|
|
|
(0.71
|
)
|
|
(1.04
|
)
|
|
(0.23
|
)
|
||||
2015
|
|
|
|
|
|
|
|
|
|||||||
Total revenues (3)
|
$
|
2,728
|
|
|
$
|
1,100
|
|
|
$
|
964
|
|
|
$
|
11,324
|
|
Product sales, net
|
812
|
|
|
852
|
|
|
745
|
|
|
1,087
|
|
||||
Gross profit (2)
|
622
|
|
|
669
|
|
|
(86
|
)
|
|
351
|
|
||||
Net loss attributable to CTI
|
(28,597
|
)
|
|
(32,596
|
)
|
|
(32,592
|
)
|
|
(25,637
|
)
|
||||
Net loss attributable to CTI common shareholders
|
(28,597
|
)
|
|
(32,596
|
)
|
|
(32,592
|
)
|
|
(28,837
|
)
|
||||
Net loss per common share—basic and diluted
|
(1.64
|
)
|
|
(1.86
|
)
|
|
(1.85
|
)
|
|
(1.27
|
)
|
(1)
|
Total revenues for the first quarter of 2016 include
$32.0 million
in milestone revenue upon achievements of two milestones during the quarter, which the payments from Baxalta relating to these milestones were received in 2015. See Note 8. Long-term Debt
for additional information. The fourth quarter of 2016 includes
$8.0 million
in milestone revenue from Servier relating to the attainment of a certain enrollment event in connection with our PIX306 study.
|
(2)
|
Gross profit is computed by subtracting cost of product sold from net product sales.
|
(3)
|
Total revenues for the fourth quarter of 2015 include
$10.0 million
of milestone payments received from Teva in
November 2015
upon the achievement of worldwide net sales milestones of TRISENOX. See Note
12. Collaboration, Licensing and Milestone Agreements
for additional information.
|
(a)
|
Financial Statements and Financial Statement Schedules
|
(i)
|
Financial Statements
|
(ii)
|
Financial Statement Schedules
|
|
|
Additions
|
|
|
|
|
|||||||||||||
|
|
|
(1)
|
|
(2)
|
|
|
|
|
||||||||||
|
Balance at
|
|
Charged to
|
|
Charged to
|
|
|
|
Balance at
|
||||||||||
|
beginning of
|
|
costs and
|
|
other
|
|
(3)
|
|
end of
|
||||||||||
Description
|
period
|
|
expenses
|
|
accounts
|
|
Deductions
|
|
period
|
||||||||||
Reserve for excess, obsolete or unsalable inventory:
|
|
|
|
|
|
|
|
|
|
||||||||||
Year ended December 31, 2016
|
$
|
1,265
|
|
|
$
|
692
|
|
|
$
|
(19
|
)
|
|
$
|
(428
|
)
|
|
$
|
1,510
|
|
Year ended December 31, 2015
|
$
|
—
|
|
|
$
|
1,326
|
|
|
$
|
(25
|
)
|
|
$
|
(36
|
)
|
|
$
|
1,265
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Allowance for doubtful accounts:
|
|
|
|
|
|
|
|
|
|
||||||||||
Year ended December 31, 2016
|
$
|
—
|
|
|
$
|
1,735
|
|
|
$
|
—
|
|
|
$
|
(1,735
|
)
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
|
|
(iii)
|
Exhibits
|
Exhibit
Number
|
|
Exhibit Description
|
|
Location
|
|
|
|
|
|
3.1
|
|
Amended and Restated Articles of Incorporation.
|
|
Incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K, filed on March 23, 2015.
|
|
|
|
|
|
3.2
|
|
Articles of Amendment to Amended and Restated Articles of Incorporation, dated October 29, 2015 (Series N Preferred Stock).
|
|
Incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K, filed on October 30, 2015.
|
|
|
|
|
|
3.3
|
|
Articles of Amendment to Amended and Restated Articles of Incorporation, dated October 29, 2015 (Series N-1 Preferred Stock).
|
|
Incorporated by reference to Exhibit 3.2 to the Registrant’s Current Report on Form 8-K, filed on October 30, 2015.
|
|
|
|
|
|
3.4
|
|
Articles of Amendment to Amended and Restated Articles of Incorporation, dated December 8, 2015 (Series N-2 Preferred Stock).
|
|
Incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K, filed on December 9, 2015.
|
|
|
|
|
|
3.5
|
|
Articles of Amendment to Amended and Restated Articles of Incorporation, dated April 29, 2016.
|
|
Incorporated by reference to Exhibit 3.5 to the Registrant’s Quarterly Report on Form 10-Q, filed on May 10, 2016.
|
|
|
|
|
|
3.6
|
|
Amendment to Amended and Restated Articles of Incorporation of CTI BioPharma Corp.
|
|
Incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K, filed on December 21, 2016.
|
|
|
|
|
|
3.7
|
|
Amended and Restated Bylaws.
|
|
Incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K, filed on December 3, 2015.
|
|
|
|
|
|
4.1
|
|
Shareholder Rights Agreement, dated December 28, 2009, between the Registrant and Computershare Trust Company, N.A.
|
|
Incorporated by reference to Exhibit 4.1 to the Registrant’s Registration Statement on Form 8-A, filed on December 28, 2009.
|
|
|
|
|
|
4.2
|
|
First Amendment to Shareholder Rights Agreement, dated as of August 31, 2012, between the Registrant and Computershare Trust Company, N.A., as Rights Agent.
|
|
Incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K, filed on September 4, 2012.
|
|
|
|
|
|
4.3
|
|
Second Amendment to Shareholder Rights Agreement, dated as of December 6, 2012, between the Registrant and Computershare Trust Company, N.A., as Rights Agent.
|
|
Incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K, filed on December 7, 2012.
|
|
|
|
|
|
4.4
|
|
Third Amendment to Shareholder Rights Agreement, dated as of December 1, 2015, between the Registrant and Computershare Trust Company, N.A., as Rights Agent.
|
|
Incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K, filed on December 1, 2015.
|
|
|
|
|
|
4.5
|
|
Specimen Common Stock Certificate.
|
|
Incorporated by reference to Exhibit 4.3 to the Registrant’s Registration Statement on Form S-3 (File No. 333-200452), filed on November 21, 2014.
|
|
|
|
|
|
4.6
|
|
Warrant Agreement, dated June 9, 2015, by and between Registrant and Hercules Technology Growth Capital, Inc.
|
|
Incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K, filed on June 10, 2015.
|
|
|
|
|
|
Exhibit
Number
|
|
Exhibit Description
|
|
Location
|
10.1
|
|
Office Lease, dated as of January 27, 2012, by and between the Registrant and Selig Holdings Company LLC.
|
|
Incorporated by reference to Exhibit 10.4 to the Registrant’s Annual Report on Form 10-K, filed on March 8, 2012.
|
|
|
|
|
|
10.2*
|
|
Employment Agreement between the Registrant and James A. Bianco, dated as of March 10, 2011.
|
|
Incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K, filed on March 15, 2011.
|
|
|
|
|
|
10.3*
|
|
Amendment to Employment Agreement between the Registrant and James A. Bianco, dated as of March 21, 2013.
|
|
Incorporated by reference to Exhibit 10.4 to the Registrant’s Quarterly Report on Form 10-Q, filed on May 2, 2013.
|
|
|
|
|
|
10.4*
|
|
Amendment No. 2 to Employment Agreement between the Registrant and James A. Bianco, dated as of January 6, 2015.
|
|
Incorporated by reference to Exhibit 10.4 to the Registrant’s Annual Report on Form 10-K, filed on March 12, 2015.
|
|
|
|
|
|
10.5*
|
|
Amendment No. 3 to Employment Agreement between the Registrant and James A. Bianco, dated as of December 23, 2015.
|
|
Incorporated by reference to Exhibit 10.5 to the Registrant’s Annual Report on Form 10-K, filed on February 2, 2016.
|
|
|
|
|
|
10.6*
|
|
Separation and Release Agreement, dated October 2, 2016, by and between the Company and James A. Bianco.
|
|
Incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K, filed on October 3, 2016.
|
|
|
|
|
|
10.7*
|
|
Offer Letter, by and between the Registrant and Matthew Plunkett, dated July 30, 2012.
|
|
Incorporated by reference to Exhibit 10.24 to the Registrant’s Annual Report on Form 10-K, filed on February 28, 2013.
|
|
|
|
|
|
10.8*
|
|
Offer Letter, by and between the Registrant and Bruce J. Seeley, dated as of July 2, 2015.
|
|
Incorporated by reference to Exhibit 10.3 to the Registrant’s Quarterly Report on Form 10-Q, filed on August 6, 2015.
|
|
|
|
|
|
10.9*
|
|
Compensation Agreement, dated October 20, 2016, by and between the Company and Richard L. Love.
|
|
Incorporated by reference to Exhibit 10.3 to the Registrant’s Current Report on Form 8-K, filed on October 24, 2016
|
|
|
|
|
|
10.10*
|
|
Stock Option Agreement, dated October 20, 2016, by and between the Company and Richard L. Love.
|
|
Incorporated by reference to Exhibit 10.4 to the Registrant’s Current Report on Form 8-K, filed on October 24, 2016
|
|
|
|
|
|
10.11*
|
|
Employment Agreement, dated February 24, 2017, by and between the Company and Adam Craig.
|
|
Incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K, filed on February 27, 2017
|
|
|
|
|
|
10.12*
|
|
Form of Severance Agreement for the Registrant’s Executive Officers other than James A. Bianco (as in effect as of January 6, 2015).
|
|
Incorporated by reference to Exhibit 10.6 to the Registrant’s Annual Report on Form 10-K, filed on March 12, 2015.
|
|
|
|
|
|
10.13*
|
|
Severance Agreement, dated as of July 27, 2015, between the Registrant and Bruce J. Seeley
|
|
Incorporated by reference to Exhibit 10.11 to the Registrant’s Annual Report on Form 10-K, filed on February 2, 2016.
|
|
|
|
|
|
Exhibit
Number
|
|
Exhibit Description
|
|
Location
|
10.14*
|
|
Director Compensation Policy.
|
|
Incorporated by reference to Exhibit 10.12 to the Registrant’s Annual Report on Form 10-K, filed on February 2, 2016.
|
|
|
|
|
|
10.15*
|
|
Form of Indemnity Agreement for the Registrant’s Executive Officers and Directors.
|
|
Incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K, filed on June 2, 2014.
|
|
|
|
|
|
10.16*
|
|
Form of Italian Indemnity Agreement for certain of the Registrant’s Executive Officers.
|
|
Incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K, filed on December 17, 2009.
|
|
|
|
|
|
10.17*
|
|
2007 Employee Stock Purchase Plan, as amended and restated.
|
|
Incorporated by reference to Appendix B to the Registrant’s Definitive Proxy Statement on Schedule 14A filed on July 29, 2015.
|
|
|
|
|
|
10.18*
|
|
CTI BioPharma Corp. 2015 Equity Incentive Plan, as amended.
|
|
Incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K, filed on April 29, 2016.
|
|
|
|
|
|
10.19*
|
|
Global Form of 2015 Equity Incentive Plan Restricted Stock Unit Award Agreement.
|
|
Incorporated by reference to Exhibit 10.3 to the Registrant’s Quarterly Report on Form 10-Q, filed on November 5, 2015.
|
|
|
|
|
|
10.20*
|
|
Global Form of 2015 Equity Incentive Plan Stock Option Agreement.
|
|
Incorporated by reference to Exhibit 10.4 to the Registrant’s Quarterly Report on Form 10-Q, filed on November 5, 2015.
|
|
|
|
|
|
10.21*
|
|
Global Form of 2015 Equity Incentive Plan Stock Bonus Award Agreement.
|
|
Incorporated by reference to Exhibit 10.5 to the Registrant’s Quarterly Report on Form 10-Q, filed on November 5, 2015.
|
|
|
|
|
|
10.22*
|
|
2007 Equity Incentive Plan, as amended and restated.
|
|
Incorporated by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q, filed on October 31, 2014.
|
|
|
|
|
|
10.23*
|
|
Form of 2007 Equity Incentive Plan Restricted Stock Award Agreement.
|
|
Incorporated by reference to Exhibit 10.14 to the Registrant’s Annual Report on Form 10-K, filed on March 12, 2015.
|
|
|
|
|
|
10.24*
|
|
Global Form of 2007 Equity Incentive Plan Restricted Stock Unit Award Agreement.
|
|
Incorporated by reference to Exhibit 10.15 to the Registrant’s Annual Report on Form 10-K, filed on March 12, 2015.
|
|
|
|
|
|
10.25*
|
|
Global Form of 2007 Equity Incentive Plan Stock Option Agreement.
|
|
Incorporated by reference to Exhibit 10.16 to the Registrant’s Annual Report on Form 10-K, filed on March 12, 2015.
|
|
|
|
|
|
|
|
|
|
|
Exhibit
Number
|
|
Exhibit Description
|
|
Location
|
10.26*
|
|
Form of 2007 Equity Incentive Plan Restricted Stock Award Agreement for the Registrant’s directors (relating to applicable awards granted prior to December 17, 2014).
|
|
Incorporated by reference to Exhibit 10.7 to the Registrant’s Quarterly Report on Form 10-Q, filed on April 26, 2011.
|
|
|
|
|
|
10.27*
|
|
Form of 2007 Equity Incentive Plan Restricted Stock Award Agreement (relating to applicable awards granted prior to December 17, 2014).
|
|
Incorporated by reference to Exhibit 10.3 to the Registrant’s Quarterly Report on Form 10-Q, filed on October 30, 2013.
|
|
|
|
|
|
10.28*
|
|
Form of 2007 Equity Incentive Plan Restricted Stock Award Agreement for employees (relating to applicable awards granted prior to December 17, 2014).
|
|
Incorporated by reference to Exhibit 10.6 to the Registrant’s Quarterly Report on Form 10-Q, filed on April 26, 2011.
|
|
|
|
|
|
10.29*
|
|
Form of 2007 Equity Incentive Plan Stock Option Agreement for the Registrant’s directors and officers (relating to applicable awards granted prior to December 17, 2014).
|
|
Incorporated by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q, filed on October 30, 2013.
|
|
|
|
|
|
10.30*
|
|
Form of Stock Award Agreement for grants of fully vested shares under the Registrant’s 2007 Equity Incentive Plan, as amended.
|
|
Incorporated by reference to Exhibit 10.2 to the Registrant’s Quarterly Report on Form 10-Q, filed on October 30, 2013.
|
|
|
|
|
|
10.31*
|
|
Form of Equity/Long-Term Incentive Award Agreement for James A. Bianco, Louis A. Bianco and Jack W. Singer.
|
|
Incorporated by reference to Exhibit 10.3 to the Registrant’s Quarterly Report on Form 10-Q, filed on April 20, 2012.
|
|
|
|
|
|
10.32*
|
|
Form of Equity/Long-Term Incentive Award Agreement for Matthew J. Plunkett.
|
|
Incorporated by reference to Exhibit 10.6 to the Registrant’s Quarterly Report on Form 10-Q, filed on May 2, 2013.
|
|
|
|
|
|
10.33*
|
|
Amendment to Form of Equity/Long-Term Incentive Award Agreement, dated as of March 21, 2013, for James A. Bianco, Louis A. Bianco, Jack W. Singer and the Registrant’s directors.
|
|
Incorporated by reference to Exhibit 10.5 to the Registrant’s Quarterly Report on Form 10-Q, filed on May 2, 2013.
|
|
|
|
|
|
10.34*
|
|
Amendment to Form of Equity/Long-Term Incentive Award Agreement, dated as of January 30, 2014.
|
|
Incorporated by reference to Exhibit 10.26 to the Registrant’s Annual Report on Form 10-K, filed on March 4, 2014.
|
|
|
|
|
|
10.35*
|
|
Form of Equity/Long-Term Incentive Award Agreement for Bruce J. Seeley.
|
|
Incorporated by reference to Exhibit 10.35 to the Registrant’s Annual Report on Form 10-K, filed on February 2, 2016.
|
|
|
|
|
|
10.36*
|
|
Form of Amendment to Form of Equity/Long-Term Incentive Award Agreement, dated as of December 23, 2015, for James A. Bianco, Louis A. Bianco and Jack W. Singer.
|
|
Incorporated by reference to Exhibit 10.36 to the Registrant’s Annual Report on Form 10-K, filed on February 2, 2016.
|
|
|
|
|
|
10.37*
|
|
Form of Amendment to Form of Equity/Long-Term Incentive Award Agreement, dated as of December 23, 2015, for Matthew J. Plunkett and Bruce J. Seeley.
|
|
Incorporated by reference to Exhibit 10.37 to the Registrant’s Annual Report on Form 10-K, filed on February 2, 2016.
|
|
|
|
|
|
Exhibit
Number
|
|
Exhibit Description
|
|
Location
|
10.38
|
|
Acquisition Agreement by and among the Registrant, Cell Technologies, Inc. and Cephalon, Inc., dated June 10, 2005.
|
|
Incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K, filed on June 14, 2005.
|
|
|
|
|
|
10.39
|
|
Acquisition Agreement among the Registrant, Cactus Acquisition Corp., Saguaro Acquisition Company LLC, Systems Medicine, Inc. and Tom Hornaday and Lon Smith dated July 24, 2007.
|
|
Incorporated by reference to Exhibit 2.1 to the Registrant’s Current Report on Form 8-K, filed on July 27, 2007.
|
|
|
|
|
|
10.40
|
|
Second Amendment to the Acquisition Agreement, dated as of August 6, 2009, by and among the Registrant and each of Tom Hornaday and Lon Smith, in their capacities as Stockholder Representatives.
|
|
Incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K, filed on August 7, 2009.
|
|
|
|
|
|
10.41†
|
|
Termination Agreement, effective January 3, 2014, by and among Novartis International Pharmaceutical Ltd. and the Registrant.
|
|
Incorporated by reference to Exhibit 10.2 to the Registrant’s Quarterly Report on Form 10-Q, filed on April 29, 2014.
|
|
|
|
|
|
10.42†
|
|
Asset Purchase Agreement, dated April 18, 2012, between S*BIO Pte Ltd. and the Registrant.
|
|
Incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K, filed on April 24, 2012.
|
|
|
|
|
|
10.43†
|
|
Master Services Agreement, dated July 9, 2012, between Quintiles Commercial Europe Limited CTI Life Sciences Ltd.
|
|
Incorporated by reference to Exhibit 10.6 to the Registrant’s Quarterly Report on Form 10-Q, filed on August 2, 2012.
|
|
|
|
|
|
10.44
|
|
Letter of Guarantee, dated July 1, 2012, between the Registrant and Quintiles Commercial Europe Limited.
|
|
Incorporated by reference to Exhibit 10.7 to the Registrant’s Quarterly Report on Form 10-Q, filed on August 2, 2012.
|
|
|
|
|
|
10.45†
|
|
Exclusive License and Collaboration Agreement by and between the Registrant, CTI Life Sciences Limited, Laboratoires Servier and Institut de Recherches Internationales Servier dated as of September 16, 2014.
|
|
Incorporated by reference to Exhibit 10.2 to the Registrant’s Quarterly Report on Form 10-Q, filed on October 31, 2014.
|
|
|
|
|
|
10.46†
|
|
Development, Commercialization and License Agreement dated as of November 14, 2013 between the Registrant, Baxter International Inc., Baxter Healthcare Corporation and Baxter Healthcare SA.
|
|
Incorporated by reference to Exhibit 10.32 to the Registrant’s Annual Report on Form 10-K, filed on March 4, 2014.
|
10.47†
|
|
First Amendment to the Development, Commercialization and License Agreement by and among the Registrant, Baxalta Incorporated, Baxalta US Inc. and Baxalta GmbH, effective June 8, 2015.
|
|
Incorporated by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q, filed on August 6, 2015.
|
|
|
|
|
|
10.48
|
|
Letter Agreement, dated September 19, 2016, by and between the Company and Baxalta.
|
|
Incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K, filed on September 19, 2016.
|
|
|
|
|
|
10.49
|
|
Second Letter Agreement, dated October 19, 2016, by and between the Company and Baxalta.
|
|
Incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K, filed on October 24, 2016
|
|
|
|
|
|
10.50
|
|
Asset Return and Termination Agreement, dated October 21, 2016, by and between the Company and Baxalta.
|
|
Incorporated by reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K, filed on October 24, 2016
|
|
|
|
|
|
Exhibit
Number
|
|
Exhibit Description
|
|
Location
|
10.51†
|
|
Drug Product Manufacturing Supply Agreement, dated July 13, 2010, by and between NerPharMa, S.r.l. and the Registrant.
|
|
Incorporated by reference to Exhibit 10.6 to the Registrant’s Quarterly Report on Form 10-Q, filed on August 6, 2010.
|
|
|
|
|
|
10.52†
|
|
Amended and Restated Exclusive License Agreement, dated October 24, 2014, by and between Vernalis (R&D) Ltd. and the Registrant.
|
|
Incorporated by reference to Exhibit 10.3 to the Registrant’s Current Report on Form 8-K/A, filed on November 6, 2014.
|
|
|
|
|
|
10.53†
|
|
Manufacturing and Supply Agreement, dated as of April 15, 2014, by and between the Registrant and DSM Fine Chemicals Austria Nfg GmbH & Co KG.
|
|
Incorporated by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q, filed on August 4, 2014.
|
|
|
|
|
|
10.54
|
|
Registration Rights Agreement, among the Registrant and Baxter Healthcare SA, dated November 14, 2013.
|
|
Incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K, filed on November 15, 2013.
|
|
|
|
|
|
10.55
|
|
Loan and Security Agreement, dated March 26, 2013, by and among the Registrant, Systems Medicine LLC and Hercules Technology Growth Capital, Inc.
|
|
Incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K, filed on March 28, 2013.
|
|
|
|
|
|
10.56
|
|
First Amendment to Loan and Security Agreement, dated March 25, 2014, by and among the Registrant, Systems Medicine LLC and Hercules Technology Growth Capital, Inc.
|
|
Incorporated by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q, filed on April 29, 2014.
|
|
|
|
|
|
10.57
|
|
Second Amendment to Loan and Security Agreement, dated October 22, 2014, by and among the Registrant, Systems Medicine LLC, Hercules Technology Growth Capital, Inc. and Hercules Capital Funding Trust 2012-1.
|
|
Incorporated by reference to Exhibit 10.48 to Registrant's Annual Report on Form 10-K, filed on March 12, 2015.
|
|
|
|
|
|
10.58
|
|
Third Amendment to Loan and Security Agreement, dated June 9, 2015, by and among Hercules Technology Growth Capital, Inc. (and certain of its affiliates), the Registrant and Systems Medicine LLC.
|
|
Incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K, filed on June 10, 2015.
|
|
|
|
|
|
10.59
|
|
Fourth Amendment to Loan and Security Agreement, dated December 11, 2015, by and among the Registrant, Systems Medicine LLC, Hercules Capital Funding Trust 2014-1 and Hercules Technology Growth Capital, Inc.
|
|
Incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K, filed on December 11, 2015.
|
|
|
|
|
|
10.60
|
|
Stipulation of Settlement, dated February 13, 2012.
|
|
Incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K, filed on February 15, 2012.
|
|
|
|
|
|
10.61
|
|
Stipulation of Settlement, dated November 6, 2012.
|
|
Incorporated by reference to Exhibit 99.2 to the Registrant’s Current Report on Form 8-K, filed on March 27, 2013.
|
|
|
|
|
|
10.62
|
|
Stipulation of Settlement
|
|
Incorporated by reference to Exhibit 99.2 to the Registrant’s Current Report on Form 8-K, filed on September 29, 2015.
|
|
|
|
|
|
10.63
|
|
Form of Subscription Agreement for Common Stock.
|
|
Incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K, filed on September 29, 2015.
|
Exhibit
Number
|
|
Exhibit Description
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Location
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10.64
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Letter Agreement, dated December 9, 2015, by and between CTI BioPharma Corp. and BVF Partners L.P.
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Incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K, filed on December 9, 2015.
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12.1
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Statement Re: Computation of Ratio of Earnings to Fixed Charges.
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Filed herewith.
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21.1
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Subsidiaries of the Registrant.
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Filed herewith.
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23.1
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Consent of Marcum LLP, Independent Registered Public Accounting Firm.
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Filed herewith.
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24.1
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Power of Attorney. Contained in the signature page of this Annual Report on Form 10-K and incorporated herein by reference.
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Filed herewith.
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31.1
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Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
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Filed herewith.
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31.2
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Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
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Filed herewith.
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32
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Certification of Chief Executive Officer and Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
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Furnished herewith.
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101.INS
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XBRL Instance
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Filed herewith.
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101.SCH
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XBRL Taxonomy Extension Schema
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Filed herewith.
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101.CAL
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XBRL Taxonomy Extension Calculation
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Filed herewith.
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101.DEF
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XBRL Taxonomy Extension Definition
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Filed herewith.
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101.LAB
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XBRL Taxonomy Extension Labels
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Filed herewith.
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101.PRE
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XBRL Taxonomy Extension Presentation
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Filed herewith.
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*
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Indicates management contract or compensatory plan or arrangement.
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†
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Portions of these exhibits have been omitted pursuant to a request for confidential treatment.
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CTI BioPharma Corp.
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By: /s/ Richard L. Love
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Richard L. Love
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Interim President and Chief Executive Officer
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Signature
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Title
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Date
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/s/ Phillip M. Nudelman
Phillip M. Nudelman, Ph.D.
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Chairman of the Board and Director
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March 2, 2017
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/s/ Richard L. Love
Richard L. Love
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Interim President and Chief Executive Officer and Director
(Principal Executive Officer)
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March 2, 2017
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/s/ Louis A. Bianco
Louis A. Bianco
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Executive Vice President, Finance and Administration
(Principal Financial Officer and Principal Accounting Officer)
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March 2, 2017
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/s/ James A. Bianco
James A. Bianco, M.D.
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Director
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March 2, 2017
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/s/ Michael A. Metzger
Michael A. Metzger
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Director
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March 2, 2017
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/s/ Matthew D. Perry
Matthew D. Perry
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Director
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March 2, 2017
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/s/ Jack W. Singer
Jack W. Singer, M.D
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Director
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March 2, 2017
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/s/ Frederick W. Telling
Frederick W. Telling, Ph.D
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Director
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March 2, 2017
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/s/ Reed V. Tuckson
Reed V. Tuckson, M.D.
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Director
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March 2, 2017
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Year ended December 31,
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2016
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2015
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2014
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2013
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2012
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Ratio of earnings to fixed charges (1)
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—
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—
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—
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—
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—
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By: /s/ Richard L. Love
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Richard L. Love
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Interim President and Chief Executive Officer
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By: /s/ Louis A. Bianco
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Louis A. Bianco
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Executive Vice President
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Finance and Administration
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Dated: March 2, 2017
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By:
/s/ Richard L. Love
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Richard L. Love
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Interim President and Chief Executive Officer
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Dated: March 2, 2017
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By:
/s/ Louis A. Bianco
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Louis A. Bianco
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Executive Vice President
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Finance and Administration
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