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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Spectrum Pharmaceuticals Inc | NASDAQ:SPPI | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 1.03 | 1.14 | 0.9785 | 0 | 01:00:00 |
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Delaware
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93-0979187
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(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer
Identification No.)
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Title of Each Class
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Name of Each Exchange on Which Registered
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Common Stock, $0.001 par value
Rights to Purchase Series B Junior Participating Preferred Stock
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The NASDAQ Stock Market, LLC
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Large accelerated filer
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¨
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Accelerated filer
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x
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Non-accelerated filer
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¨
(Do not check if a smaller reporting company)
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Smaller reporting company
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¨
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Page
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PART I
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PART II
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PART III
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PART IV
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•
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our ability to successfully develop, obtain regulatory approval for and market our products;
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our ability to continue to grow sales revenue of our marketed products;
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•
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risks associated with doing business internationally;
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•
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our ability to generate and maintain sufficient cash resources to fund our business;
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•
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our ability to enter into strategic alliances with partners for manufacturing, development and commercialization;
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•
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efforts of our development partners;
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•
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the ability of our manufacturing partners to meet our timelines;
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•
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the ability to timely deliver product supplies to our customers;
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•
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our ability to identify new product candidates and to successfully integrate those product candidates into our operations;
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•
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the timing and/or results of pending or future clinical trials, and our reliance on contract research organizations;
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•
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our ability to protect our intellectual property rights;
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•
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competition in the marketplace for our drugs;
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•
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delay in approval of our products or new indications for our products by the U.S. Food and Drug Administration, or the FDA;
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•
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actions by the FDA and other regulatory agencies, including international agencies;
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•
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securing positive reimbursement for our products;
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•
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the impact of any product liability, or other litigation to which we are, or may become a party;
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•
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the impact of legislative or regulatory reform of the healthcare industry and the impact of recently enacted healthcare reform legislation;
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•
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the availability and price of acceptable raw materials and components from third-party suppliers, and their ability to meet our demands;
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•
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our ability, and that of our suppliers, development partners, and manufacturing partners, to comply with laws, regulations and standards, and the application and interpretation of those laws, regulations and standards, that govern or affect the pharmaceutical and biotechnology industries, the non-compliance with which may delay or prevent the development, manufacturing, regulatory approvals and sale of our products;
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•
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defending against claims relating to improper handling, storage or disposal of hazardous chemical, radioactive or biological materials which could be time consuming and expensive;
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•
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our ability to maintain the services of our key executives and technical and sales and marketing personnel;
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•
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the difficulty in predicting the timing or outcome of product development efforts and regulatory approvals; and
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•
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demand and market acceptance for our approved products.
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•
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ROLONTIS (previously referred to as SPI-2012 or LAPS-G-CSF) for chemotherapy-induced neutropenia.
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•
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QAPZOLA (previously referred to as APAZIQUONE) for immediate intravesical instillation in post-transurethral resection of bladder tumors in patients with non-muscle invasive bladder cancer, or NMIBC.
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•
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POZIOTINIB, a novel pan-HER inhibitor used in the treatment of patients with a variety of solid tumors, including breast and lung cancer.
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•
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in combination chemotherapy with 5-fluorouracil in the palliative treatment of patients with advanced mCRC;
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•
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for rescue after high-dose methotrexate, or MTX, therapy in osteosarcoma; and
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•
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to diminish the toxicity and counteract the effects of impaired MTX elimination and of inadvertent over dosage of folic acid antagonists.
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•
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the highly implantable nature of cancer cells that are dispersed during surgery;
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•
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incomplete tumor resection; and
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•
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tumors present in multiple locations in the bladder which may be missed or too small to visualize at the time of resection.
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•
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reducing tumor recurrence by destroying dispersed cancer cells that would otherwise re-implant onto the inner lining of the bladder;
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•
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destroying remaining cancer cells at the site of tumor resection (also known as chemo-resection); and
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•
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destroying tumors not observed during resection (also known as chemo-ablation).
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Product Sales
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|||||||
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2016
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2015
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2014
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|||
AmerisourceBergen Corporation, and its affiliates
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38.4
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%
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36.7
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%
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|
40.4
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%
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McKesson Corporation and its affiliates
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31.0
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%
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34.2
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%
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32.9
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%
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Cardinal Health, Inc. and its affiliates
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24.0
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%
|
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17.4
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%
|
|
*
|
|
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Accounts Receivable, net
|
||||
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December 31, 2016
|
|
December 31, 2015
|
||
AmerisourceBergen Corporation, and its affiliates
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33.9
|
%
|
|
*
|
|
Cardinal Health, Inc. and its affiliates
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33.0
|
%
|
|
23.8
|
%
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McKesson Corporation and its affiliates
|
26.1
|
%
|
|
66.7
|
%
|
(a)
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FUSILEV
is the levo-isomeric form of the racemic compound calcium, leucovorin, a product already approved for the same indication as FUSILEV. As there are currently four generic companies approved by the FDA to sell the leucovorin product, we are competing with a lower-cost alternative. For additional information, see the discussion under the heading
Patents and Proprietary Rights
below and Item
1A. Risk Factors -- Risks Related to Our Business -- Generic levo-leucovorin product competition could further adversely affect our FUSILEV revenues.
|
(b)
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ZEVALIN
has two competitive products for its currently approved indications:
|
•
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Rituxan
®
(rituximab), marketed by Genentech Inc. and Biogen Inc., is indicated for the treatment of patients with relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent; previously untreated follicular, CD20-positive, B-cell NHL in combination with CVP (cyclophosphamide, vincristine and prednisone combination) chemotherapy; and non-progressing (including stable disease), low-grade, CD20-positive B-cell NHL, as a single agent, after first-line CVP chemotherapy. Rituxan is administered as a part of various chemotherapy regimens and schedules, the vast majority of which, could be used in concert with other therapeutic agents, such as ZEVALIN, as part of a treatment plan.
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•
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Bendeka®
(bendamustine hydrochloride) for Injection, for Intravenous Infusion, marketed by Teva Pharmaceutical Industries Ltd., is indicated for the treatment of patients with indolent B-cell NHL that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.
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(c)
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FOLOTYN
, was the first agent approved by the FDA for treatment of patients with relapsed or refractory PTCL.
BELEODAQ
is a HDAC inhibitor, also indicated for the treatment of patients with relapsed or refractory PTCL. Both drugs were approved under accelerated approval based on tumor response rate. Clinical benefit such as improvement in progression-free survival or overall survival has not been demonstrated. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
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•
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Istodax
®
(Romidepsin), marketed by Celgene Corporation, was granted accelerated approval by the FDA in June 2011 for the treatment of patients with PTCL who have received at least one prior therapy.
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•
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Adcetris
® (
Brentuximab vedotin), marketed by Seattle Genetics, Inc., was granted accelerated approval by the FDA in August 2011 for the treatment of patients with systemic anaplastic large cell lymphoma, or ALCL, after failure of at least one prior multi-agent chemotherapy regimen. ALCL is one of the subtypes of PTCL included in the labels of FOLOTYN, BELEODAQ and Istodax.
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(d)
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MARQIBO
is a liposomal form of standard vincristine. In its current indication, MARQIBO is approved for adult patients with relapsed or refractory Ph-ALL who have not responded or relapsed after two prior treatments. This indication received the FDA's accelerated approval based on tumor response rate. Clinical benefit such as improvement in overall survival has not been verified. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
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Research and Development Expenses for the Year Ended December 31,
(in thousands) |
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||||||||||
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2016
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2015
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2014
|
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||||||
ROLONTIS
|
$
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14,829
|
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*
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$
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1,133
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$
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4,141
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QAPZOLA
|
5,437
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4,147
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1,377
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EVOMELA
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4,964
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8,568
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5,966
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MARQIBO
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4,249
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4,412
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6,623
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ZEVALIN
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3,814
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3,025
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6,950
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LEVOLEUCOVORIN (new formulation)
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2,667
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—
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|
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—
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FOLOTYN
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1,717
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2,650
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4,927
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|
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POZIOTINIB
|
976
|
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|
4,240
|
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—
|
|
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BELEODAQ
|
772
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1,320
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20,911
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|
**
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FUSILEV
|
—
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885
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442
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|||
Other in-development compounds and drugs
|
283
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|
|
633
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|
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1,967
|
|
|
|||
Total — Direct costs
|
39,708
|
|
|
31,013
|
|
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53,304
|
|
|
|||
Add: General research and development expenses (including personnel costs that correspond to more than one in-development project)
|
21,148
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21,571
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21,073
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|||
(Less): Reimbursements from development partners of ROLONTIS and BELEODAQ
|
(1,710
|
)
|
|
(521
|
)
|
|
(2,758
|
)
|
|
|||
(Less): Incurred FOLOTYN study costs that credit expense and reduce our drug development liability (see
Note 16
to Consolidated Financial Statements)
|
(210
|
)
|
|
(1,297
|
)
|
|
(1,957
|
)
|
|
|||
Total research and development expenses
|
$
|
58,936
|
|
|
$
|
50,766
|
|
|
$
|
69,662
|
|
|
•
|
delays obtaining regulatory approval to commence a trial;
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•
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reaching agreement on acceptable terms with contract research organizations, or CROs, and clinical trial sites;
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•
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obtaining institutional review board, or IRB, approval at each site;
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•
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slower than anticipated patient enrollment;
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•
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scheduling conflicts with participating clinicians and clinical institutions;
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•
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lack of funding;
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•
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negative or inconclusive results;
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•
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patient noncompliance with the protocol;
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•
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adverse medical events or side effects among patients during the clinical trials;
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•
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negative or problematic FDA inspections of our clinical operations or manufacturing operations; and
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•
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real or perceived lack of effectiveness or safety.
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•
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not provide us with accurate or timely information regarding their inventories, the number of patients who are using our products or complaints about our products;
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•
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not purchase sufficient inventory on hand to fulfill end user orders in a timely manner;
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•
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be unable to satisfy financial obligations to us or others; and
|
•
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cease operations.
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•
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conforming standards, procedures and policies, business cultures and compensation structures;
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•
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conforming information technology and accounting systems;
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•
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consolidating corporate and administrative infrastructures;
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•
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consolidating sales and marketing operations;
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•
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retaining existing customers and attracting new customers;
|
•
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retaining key employees;
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•
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identifying and eliminating redundant and under-performing operations and assets;
|
•
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minimizing the diversion of management’s attention from ongoing business concerns;
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•
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coordinating geographically dispersed organizations;
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•
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managing tax costs or inefficiencies associated with integrating operations; and
|
•
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making any necessary modifications to operating control standards to comply with the Sarbanes-Oxley Act of 2002 and the rules and regulations promulgated thereunder.
|
•
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unwillingness on the part of a third-party development partner to pay us milestone payments or royalties that we believe are due to us under a collaboration;
|
•
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uncertainty regarding ownership of intellectual property rights arising from our collaborative activities, which could prevent us from entering into additional collaborations;
|
•
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unwillingness to cooperate in the manufacture of the product, including providing us with product data or materials;
|
•
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unwillingness to keep us informed regarding the progress of its development and commercialization activities or to permit public disclosure of the results of those activities;
|
•
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initiation of litigation or alternative dispute resolution options by either party to resolve the dispute;
|
•
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attempts by either party to terminate the collaboration;
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•
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our ability to maintain or defend our intellectual property rights may be compromised by our partner’s acts or omissions;
|
•
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a third-party development partner may utilize our intellectual property rights in such a way as to invite litigation that could jeopardize or invalidate our intellectual property rights or expose us to potential liability;
|
•
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a third-party development partner may change the focus of its development and commercialization efforts due to internal reorganizations, mergers, consolidations and otherwise;
|
•
|
unwillingness to fully fund or commit sufficient resources to the testing, marketing, distribution or development of our products;
|
•
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unwillingness or inability to fulfill their obligations to us due to the pursuit of alternative products, conflicts of interest that arise or changes in business strategy or other business issues; and/or
|
•
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we may not be able to guarantee supplies of development or marketed products.
|
•
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restrictions on FOLOTYN or our manufacturing processes;
|
•
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warning letters;
|
•
|
withdrawal of FOLOTYN from the market;
|
•
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voluntary or mandatory recall of FOLOTYN;
|
•
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fines against us;
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•
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suspension or withdrawal of regulatory approvals for FOLOTYN;
|
•
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suspension or termination of any of our ongoing clinical trials of FOLOTYN;
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•
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refusal to permit import or export of FOLOTYN;
|
•
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refusal to approve pending applications or supplements to approved applications that we submit;
|
•
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denial of permission to file an application or supplement in a jurisdiction;
|
•
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product seizure; and/or
|
•
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injunctions, consent decrees, or the imposition of civil or criminal penalties against us.
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•
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interpretations of existing tax laws;
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•
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the accounting for stock options and other share-based compensation;
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•
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changes in tax laws and rates;
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•
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future levels of research and development spending;
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•
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changes in accounting standards;
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•
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changes in the mix of earnings in the various tax jurisdictions in which we operate;
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•
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the outcome of examinations by the Internal Revenue Service and other jurisdictions;
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•
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the accuracy of our estimates for unrecognized tax benefits;
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•
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realization of deferred tax assets; and
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•
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changes in overall levels of pre-tax earnings.
|
•
|
in certain jurisdictions, we or our licensors might not have been the first to make the inventions covered by each of our or our licensors’ pending patent applications and issued patents, and we may have to participate in expensive and protracted interference proceedings to determine priority of invention;
|
•
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we or our licensors might not have been the first to file patent applications for these inventions;
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•
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others may independently develop similar or alternative product candidates or duplicate any of our or our licensors’ product candidates;
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•
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our or our licensors’ pending patent applications may not result in issued patents;
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•
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our or our licensors’ issued patents may not provide a basis for commercially viable products or may not provide us with any competitive advantages or may be challenged by third parties;
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•
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others may design around our or our licensors’ patent claims to produce competitive products that fall outside the scope of our or our licensors’ patents;
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•
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we may not develop or in-license additional patentable proprietary technologies related to our product candidates; or
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•
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the patents of others may prevent us from marketing one or more of our product candidates for one or more indications that may be valuable to our business strategy.
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•
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pay damages, including up to treble damages and the other party’s attorneys’ fees, which may be substantial;
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•
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cease the development, manufacture, use and sale of our products that infringe the patent rights of others through a court-imposed sanction such as an injunction;
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•
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expend significant resources to redesign our products so they do not infringe others’ patent rights, which may not be possible;
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•
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discontinue manufacturing or other processes incorporating infringing technology; or
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•
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obtain licenses to the infringed intellectual property, which may not be available to us on acceptable terms, or at all.
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•
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the effectiveness of the drug product;
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•
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the prevalence and severity of any side effects;
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•
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potential advantages or disadvantages over alternative treatments;
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•
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relative convenience and ease of administration;
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•
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the strength of marketing and distribution support;
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•
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the price of the drug product, both in absolute terms and relative to alternative treatments; and
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•
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sufficient third-party coverage and reimbursement.
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•
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warning letters;
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•
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fines;
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•
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changes in advertising;
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•
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revocation or suspension of regulatory approvals of products;
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•
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product recalls or seizures;
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•
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delays, interruption, or suspension of product distribution, marketing and sales;
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•
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civil or criminal sanctions;
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•
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suspension or termination of ongoing clinical trials;
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•
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imposition of restrictions on our operations;
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•
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close the facilities of our CMOs (resulting in our delay or inability to manufacture affected drug products); and
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•
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refusals to approve new products.
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•
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require sponsors of marketed products to conduct post-approval clinical studies to assess a known serious risk, signals of serious risk or to identify an unexpected serious risk;
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•
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mandate labeling changes to products, at any point in a product’s lifecycle, based on new safety information; and
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•
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require sponsors to implement a REMS for a product which could include a medication guide, patient package insert, a communication plan to healthcare providers, or other elements as the FDA deems are necessary to assure safe use of the drug (either prior to approval or post-approval as necessary).
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•
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a covered benefit under its health plan;
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•
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safe, effective and medically necessary;
|
•
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appropriate for the specific patient;
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•
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cost-effective; and
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•
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neither experimental nor investigational.
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•
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recognition on up-front licensing or other fees or revenues;
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•
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payments of non-refundable up-front or license fees, or payment for cost-sharing expenses, to third parties;
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•
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adverse results or delays in our clinical trials;
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•
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fluctuations in our results of operations;
|
•
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timing and announcements of our technological innovations or new products or those of our competitors;
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•
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developments concerning any strategic alliances or acquisitions we may enter into;
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•
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announcements of FDA non-approval of our products, or delays in the FDA or other foreign regulatory review process or actions;
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•
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changes in recommendations or guidelines of government agencies or other third parties regarding the use of our products;
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•
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adverse actions taken by regulatory agencies with respect to our drug products, clinical trials, manufacturing processes or sales and marketing activities;
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•
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concerns about our products being reimbursed;
|
•
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any lawsuit involving us or our products;
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•
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developments with respect to our patents and proprietary rights;
|
•
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public concern as to the safety of products developed by us or others;
|
•
|
regulatory developments in the U.S. and in foreign countries;
|
•
|
changes in stock market analyst recommendations regarding our common stock or lack of analyst coverage;
|
•
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the pharmaceutical industry generally and general market conditions;
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•
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failure of our results of operations to meet the expectations of stock market analysts and investors;
|
•
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sales of our common stock by our executive officers, directors and significant stockholders or sales of substantial amounts of our common stock generally;
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•
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hedging or arbitrage transactions by holders of our convertible notes;
|
•
|
changes in accounting principles; and
|
•
|
loss of any of our key scientific or management personnel.
|
•
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the ability of our board of directors to amend our bylaws without stockholder approval;
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•
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the inability of stockholders to call special meetings;
|
•
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the ability of members of the board of directors to fill vacancies on the board of directors;
|
•
|
the inability of stockholders to act by written consent, unless such consent is unanimous; and
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•
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the establishment of advance notice requirements for nomination for election to our board of directors or for proposing matters that can be acted on by stockholders at stockholder meetings.
|
|
High
|
|
Low
|
||||
Year Ended December 31, 2016:
|
|
|
|
||||
First Quarter
|
$
|
6.36
|
|
|
$
|
4.28
|
|
Second Quarter
|
7.65
|
|
|
6.33
|
|
||
Third Quarter
|
7.10
|
|
|
4.47
|
|
||
Fourth Quarter
|
4.79
|
|
|
3.22
|
|
||
Year Ended December 31, 2015:
|
|
|
|
||||
First Quarter
|
$
|
7.66
|
|
|
$
|
5.95
|
|
Second Quarter
|
7.37
|
|
|
5.65
|
|
||
Third Quarter
|
7.60
|
|
|
5.92
|
|
||
Fourth Quarter
|
6.93
|
|
|
5.07
|
|
Period
|
Total Number of Shares Purchased
|
|
Average Price Paid Per Share
|
|
Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs
|
|
Maximum Number of Shares (or Approximate Dollar Value) that May Yet Be Purchased Under the Plans or Programs
|
||||||
January 1, 2016 - December 31, 2016
|
266,860
|
|
|
$
|
5.32
|
|
|
—
|
|
|
$
|
—
|
|
•
|
AMAG Pharmaceuticals, Inc.
|
•
|
Albany Molecular Research Inc.
|
•
|
Affymetrix, Inc.
|
•
|
Genomic Health, Inc.
|
•
|
Luminex Corporation
|
•
|
Amphastar Pharmaceuticals, Inc.
|
•
|
MiMedx Group, Inc.
|
•
|
Pernix Therapeutics Holdings, Inc.
|
•
|
SciClone Pharmaceuticals, Inc.
|
•
|
Supernus Pharmaceuticals, Inc.
|
•
|
Halozyme Therapeutics, Inc.
|
•
|
Sucampo Pharmaceuticals, Inc.
|
•
|
Enanta Pharmaceuticals, Inc.
|
•
|
Sequenom Inc.
|
•
|
Fluidigm Corporation
|
•
|
Harvard Bioscience, Inc.
|
•
|
Vanda Pharmaceuticals Inc.
|
•
|
Infinity Pharmaceuticals, Inc.
|
•
|
VIVUS, Inc.
|
•
|
Merrimack Pharmaceuticals, Inc.
|
•
|
NewLink Genetics Corporation
|
•
|
Eagle Pharmaceuticals, Inc.
|
•
|
Acorda Therapeutics, Inc.
|
•
|
Aegerion Pharmaceuticals, Inc.
|
•
|
Auxilium Pharmaceuticals, Inc.
|
•
|
Dendreon Corp.
|
•
|
DepoMed Inc.
|
•
|
Emergent BioSolutions, Inc.
|
•
|
Genomic Health Inc.
|
•
|
Hyperion Therapeutics, Inc.
|
•
|
INSYS Therapeutics, Inc.
|
•
|
Sagent Pharmaceuticals, Inc.
|
•
|
SciClone Pharmaceuticals, Inc.
|
•
|
Sucampo Pharmaceuticals, Inc.
|
•
|
Supernus Pharmaceuticals, Inc.
|
•
|
The Medicines Company
|
•
|
VIVUS Inc.
|
|
12/31/2011
|
|
12/31/2012
|
|
12/31/2013
|
|
12/31/2014
|
|
12/31/2015
|
|
12/31/2016
|
||||||||||||
Spectrum Pharmaceuticals, Inc.
|
$
|
100
|
|
|
$
|
77
|
|
|
$
|
61
|
|
|
$
|
48
|
|
|
$
|
42
|
|
|
$
|
31
|
|
Russell 2000
|
$
|
100
|
|
|
$
|
116
|
|
|
$
|
162
|
|
|
$
|
169
|
|
|
$
|
162
|
|
|
$
|
196
|
|
Old Peer Group
|
$
|
100
|
|
|
$
|
116
|
|
|
$
|
141
|
|
|
$
|
152
|
|
|
$
|
185
|
|
|
$
|
147
|
|
New Peer Group
|
$
|
100
|
|
|
$
|
126
|
|
|
$
|
123
|
|
|
$
|
143
|
|
|
$
|
139
|
|
|
$
|
131
|
|
(1)
|
The information in this section is not “soliciting material,” is not deemed “filed” with the SEC and is not to be incorporated by reference in any filing of the Company under the Securities Act or the Exchange Act, whether made before or after the date hereof and irrespective of any general incorporation language in any such filing.
|
|
Year ended December 31,
|
||||||||||||||||||
Selected Statement of Operations Data:
|
2016
|
|
2015
|
|
2014
|
|
2013
|
|
2012
|
||||||||||
|
(In thousands, except per share data)
|
||||||||||||||||||
Total revenues
|
$
|
146,444
|
|
|
$
|
162,556
|
|
|
$
|
186,830
|
|
|
$
|
155,854
|
|
|
$
|
267,707
|
|
Operating costs and expenses:
|
|
|
|
|
|
|
|
|
|
||||||||||
Cost of product sales (excludes amortization and impairment of intangible assets)
|
27,953
|
|
|
27,689
|
|
|
27,037
|
|
|
28,580
|
|
|
46,633
|
|
|||||
Cost of service revenue
|
7,890
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Selling, general and administrative
|
87,347
|
|
|
86,514
|
|
|
97,412
|
|
|
99,315
|
|
|
89,922
|
|
|||||
Research and development
|
58,936
|
|
|
50,766
|
|
|
69,662
|
|
|
46,670
|
|
|
41,560
|
|
|||||
Amortization and impairment of intangible assets
|
25,946
|
|
|
38,319
|
|
|
24,288
|
|
|
20,074
|
|
|
8,818
|
|
|||||
(Loss) Income from operations
|
(61,628
|
)
|
|
(40,732
|
)
|
|
(31,569
|
)
|
|
(38,785
|
)
|
|
80,774
|
|
|||||
Change in fair value of contingent consideration related to acquisitions
|
(649
|
)
|
|
676
|
|
|
987
|
|
|
2,871
|
|
|
—
|
|
|||||
Other (expense), net
|
(8,548
|
)
|
|
(10,323
|
)
|
|
(12,951
|
)
|
|
(722
|
)
|
|
(844
|
)
|
|||||
(Loss) income before provision for income taxes
|
(70,825
|
)
|
|
(50,379
|
)
|
|
(43,533
|
)
|
|
(36,636
|
)
|
|
79,930
|
|
|||||
Benefit (provision) for income taxes
|
2,313
|
|
|
(406
|
)
|
|
(2,186
|
)
|
|
(25,498
|
)
|
|
14,271
|
|
|||||
Net (loss) income
|
$
|
(68,512
|
)
|
|
$
|
(50,785
|
)
|
|
$
|
(45,719
|
)
|
|
$
|
(62,134
|
)
|
|
$
|
94,201
|
|
Net (loss) income per share—basic
|
$
|
(0.94
|
)
|
|
$
|
(0.78
|
)
|
|
$
|
(0.71
|
)
|
|
$
|
(1.02
|
)
|
|
$
|
1.61
|
|
Net (loss) income per share—diluted
|
$
|
(0.94
|
)
|
|
$
|
(0.78
|
)
|
|
$
|
(0.71
|
)
|
|
$
|
(1.02
|
)
|
|
$
|
1.46
|
|
|
As of December 31,
|
||||||||||||||||||
Selected Balance Sheet Data:
|
2016
|
|
2015
|
|
2014
|
|
2013
|
|
2012
|
||||||||||
|
(In thousands)
|
||||||||||||||||||
Working capital surplus (current assets
minus
current liabilities)
|
$
|
151,137
|
|
|
$
|
114,282
|
|
|
$
|
113,030
|
|
|
$
|
145,206
|
|
|
$
|
141,630
|
|
Total assets
|
$
|
428,768
|
|
|
$
|
419,049
|
|
|
$
|
490,033
|
|
|
$
|
499,155
|
|
|
$
|
504,955
|
|
Long term obligations, less current portion
|
$
|
127,229
|
|
|
$
|
129,849
|
|
|
$
|
126,040
|
|
|
$
|
127,565
|
|
|
$
|
93,031
|
|
Total stockholders’ equity
|
$
|
236,026
|
|
|
$
|
212,857
|
|
|
$
|
254,554
|
|
|
$
|
281,606
|
|
|
$
|
288,681
|
|
•
|
ROLONTIS
(formerly referred to as SPI-2012 or LAPS-G-CSF) for chemotherapy-induced neutropenia.
|
•
|
QAPZOLA
(formerly referred to as APAZIQUONE) for immediate intravesical instillation in post-transurethral resection of bladder tumors in patients with NMIBC.
|
•
|
POZIOTINIB
, a novel pan-HER inhibitor used in the treatment of patients with a variety of solid tumors, including breast and lung cancer.
|
•
|
Company Overview
|
•
|
Cancer Background and Market Size
|
•
|
Product Portfolio
|
•
|
Manufacturing
|
•
|
Sales and Marketing
|
•
|
Customers
|
•
|
Competition
|
•
|
Research and Development
|
•
|
ROLONTIS, a novel long-acting G-CSF:
A pivotal Phase 3 study (ADVANCE Study, or SPI-GCF-301) was initiated in the first quarter of 2016 to evaluate ROLONTIS as a treatment for chemotherapy-induced neutropenia in patients with breast cancer. The study uses a fixed dose of ROLONTIS and is randomized to be compared to Neulasta with non-inferiority of duration of severe neutropenia as the primary endpoint. This study will be conducted in the United States, Canada, and South Korea. A second pivotal Phase 3 study (RECOVER Study, or SPI-GCF-302) with an identical study design is also planned. This study will enroll patients globally including in Europe and the United States.
|
•
|
QAPZOLA, a potent tumor-activated drug being investigated for NMIBC:
We submitted a New Drug Application, or NDA, on December 11, 2015 which was accepted on February 9, 2016. On November 17, 2016, we received a Complete Response Letter, or CRL. We have since developed a new Phase 3 study for QAPZOLA, and in February 2017, we received a SPA from the FDA. The new Phase 3 study has been specifically designed to build on learnings from the previous studies as well as recommendations from the FDA. Compared to the previous study, this study will use twice the dosage of QAPZOLA (8mg), will evaluate approximately 70% fewer patients (n=425), and will also evaluate time-to-recurrence as the primary endpoint compared to recurrence at two years.
|
•
|
POZIOTINIB, a novel pan-HER inhibitor:
In March 2016, we initiated a Phase 2 Breast Cancer Trial. The Phase 2 study is an open-label study that will enroll approximately 75 patients with HER-2 positive metastatic breast cancer, who have failed at least two and no more than four HER-2 directed therapies. The dose and schedule of oral POZIOTINIB is based on clinical experience from the studies in South Korea, and in addition include the use of prophylactic therapies to help minimize known side-effects of pan-HER directed therapies.
I
n collaboration with The University of Texas MD Anderson Cancer Center, an investigator sponsored trial is being initiated in non-small cell
|
•
|
EVOMELA (formerly referred to as Captisol-Enabled MELPHALAN):
On March 10, 2016, the FDA approved EVOMELA as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with MM, and for the palliative treatment of patients with MM for whom oral therapy is not appropriate. In April 2016, we launched EVOMELA, our sixth anti-cancer drug, with our existing sales force. On April 20, 2016, the FDA granted orphan drug designation to EVOMELA, giving us seven years of marketing exclusivity and two composition of matter patents that do not expire until March 2029.
|
•
|
Out-license with Servier Canada:
On January 8, 2016, we entered into a strategic partnership with Servier Canada, Inc. for the out-licenses of ZEVALIN, FOLOTYN, BELEODAQ, and MARQIBO. We received $6 million in upfront payments in the first quarter of 2016 which was recognized within "license fees and service revenue" in the accompanying Consolidated Statements of Operations. We will also receive development milestone payments upon achievement of regulatory milestones, and a high single-digit royalty on their sales of these products.
|
•
|
Revenue recognition
|
•
|
Inventories – lower of cost or market
|
•
|
Fair value of acquired assets and assumed liabilities
|
•
|
Goodwill and intangible assets – impairment evaluations
|
•
|
Income taxes
|
•
|
Stock-based compensation
|
•
|
Litigation accruals (as required)
|
(1)
|
appropriate evidence of a binding arrangement exists with our customer;
|
(2)
|
price is substantially fixed or determinable;
|
(3)
|
collection from our customer is reasonably assured;
|
(4)
|
our customer’s obligation to pay us is not contingent on resale of the product;
|
(5)
|
we do not have significant continued performance obligations to our customer; and
|
(6)
|
we have a reasonable basis to estimate returns.
|
|
Year Ended December 31,
|
|||||||||||||||||||
|
2016
|
|
2015
|
|
2014
|
|||||||||||||||
|
($ in thousands)
|
|||||||||||||||||||
Total revenues
|
$
|
146,444
|
|
|
100.0
|
%
|
|
$
|
162,556
|
|
|
100.0
|
%
|
|
$
|
186,830
|
|
|
100.0
|
%
|
Operating costs and expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||
Cost of product sales (excludes amortization and impairment of intangible assets)
|
27,953
|
|
|
19.1
|
%
|
|
27,689
|
|
|
17.0
|
%
|
|
27,037
|
|
|
14.5
|
%
|
|||
Cost of service revenue
|
7,890
|
|
|
5.4
|
%
|
|
—
|
|
|
—
|
%
|
|
—
|
|
|
—
|
%
|
|||
Selling, general and administrative
|
87,347
|
|
|
59.6
|
%
|
|
86,514
|
|
|
53.2
|
%
|
|
97,412
|
|
|
52.1
|
%
|
|||
Research and development
|
58,936
|
|
|
40.2
|
%
|
|
50,766
|
|
|
31.2
|
%
|
|
69,662
|
|
|
37.4
|
%
|
|||
Amortization and impairment charges of intangible assets
|
25,946
|
|
|
17.7
|
%
|
|
38,319
|
|
|
23.6
|
%
|
|
24,288
|
|
|
13.0
|
%
|
|||
Total operating costs and expenses
|
208,072
|
|
|
>100.0
|
%
|
|
203,288
|
|
|
>100.0
|
%
|
|
218,399
|
|
|
>100.0
|
%
|
|||
Loss from operations
|
(61,628
|
)
|
|
(42.1
|
)%
|
|
(40,732
|
)
|
|
(25.1
|
)%
|
|
(31,569
|
)
|
|
(16.9
|
)%
|
|||
Interest expense, net
|
(9,435
|
)
|
|
(6.4
|
)%
|
|
(9,074
|
)
|
|
(5.6
|
)%
|
|
(8,584
|
)
|
|
(4.6
|
)%
|
|||
Change in fair value of contingent consideration related to acquisitions
|
(649
|
)
|
|
(0.4
|
)%
|
|
676
|
|
|
0.4
|
%
|
|
987
|
|
|
0.1
|
%
|
|||
Other income (expense), net
|
887
|
|
|
0.6
|
%
|
|
(1,249
|
)
|
|
(0.8
|
)%
|
|
(4,367
|
)
|
|
(2.3
|
)%
|
|||
Loss before income tax
|
(70,825
|
)
|
|
(48.4
|
)%
|
|
(50,379
|
)
|
|
(31.0
|
)%
|
|
(43,533
|
)
|
|
(23.3
|
)%
|
|||
Benefit (provision) for income taxes
|
2,313
|
|
|
1.6
|
%
|
|
(406
|
)
|
|
(0.2
|
)%
|
|
(2,186
|
)
|
|
(1.1
|
)%
|
|||
Net loss
|
$
|
(68,512
|
)
|
|
(46.8
|
)%
|
|
$
|
(50,785
|
)
|
|
(31.2
|
)%
|
|
$
|
(45,719
|
)
|
|
(24.5
|
)%
|
|
Year Ended December 31,
|
|
|
|
|
|||||||||
|
2016
|
|
2015
|
|
$ Change
|
|
% Change
|
|||||||
|
($ in millions)
|
|
|
|
|
|||||||||
Product sales, net:
|
|
|
|
|
|
|
|
|||||||
FUSILEV
|
$
|
34.8
|
|
|
$
|
60.7
|
|
|
$
|
(25.9
|
)
|
|
(42.7
|
)%
|
FOLOTYN
|
46.2
|
|
|
40.6
|
|
|
5.6
|
|
|
13.8
|
%
|
|||
ZEVALIN
|
10.7
|
|
|
17.5
|
|
|
(6.8
|
)
|
|
(38.9
|
)%
|
|||
MARQIBO
|
7.2
|
|
|
8.0
|
|
|
(0.8
|
)
|
|
(10.0
|
)%
|
|||
BELEODAQ
|
13.4
|
|
|
10.1
|
|
|
3.3
|
|
|
32.7
|
%
|
|||
EVOMELA
|
16.2
|
|
|
—
|
|
|
16.2
|
|
|
100.0
|
%
|
|||
|
128.6
|
|
|
136.9
|
|
|
(8.3
|
)
|
|
(6.1
|
)%
|
|||
License fees and service revenue
|
17.8
|
|
|
25.7
|
|
|
(7.9
|
)
|
|
(30.7
|
)%
|
|||
Total revenues
|
$
|
146.4
|
|
|
$
|
162.6
|
|
|
$
|
(16.2
|
)
|
|
(10.0
|
)%
|
|
Year Ended December 31,
|
|
|
|
|
|||||||||
|
2016
|
|
2015
|
|
$ Change
|
|
% Change
|
|||||||
|
($ in millions)
|
|
|
|
|
|||||||||
Operating expenses:
|
|
|
|
|
|
|
|
|||||||
Cost of product sales (excludes amortization and impairment of intangible assets)
|
$
|
28.0
|
|
|
$
|
27.7
|
|
|
$
|
0.3
|
|
|
1.1
|
%
|
Cost of service revenue
|
7.9
|
|
|
—
|
|
|
7.9
|
|
|
100.0
|
%
|
|||
Selling, general and administrative
|
87.3
|
|
|
86.5
|
|
|
0.8
|
|
|
0.9
|
%
|
|||
Research and development
|
58.9
|
|
|
50.8
|
|
|
8.1
|
|
|
15.9
|
%
|
|||
Amortization and impairment charges of intangible assets
|
25.9
|
|
|
38.3
|
|
|
(12.4
|
)
|
|
(32.4
|
)%
|
|||
Total operating costs and expenses
|
$
|
208.1
|
|
|
$
|
203.3
|
|
|
$
|
4.8
|
|
|
2.4
|
%
|
|
Year Ended December 31,
|
|
|
|
|
|||||||||
|
2016
|
|
2015
|
|
$ Change
|
|
% Change
|
|||||||
|
($ in millions)
|
|
|
|
|
|||||||||
Total other expense
|
$
|
(9.2
|
)
|
|
$
|
(9.6
|
)
|
|
$
|
0.4
|
|
|
4.2
|
%
|
|
Year Ended December 31,
|
|
|
|
|
|||||||||
|
2016
|
|
2015
|
|
$ Change
|
|
% Change
|
|||||||
|
($ in millions)
|
|
|
|
|
|||||||||
Benefit (provision) for income taxes
|
$
|
2.3
|
|
|
$
|
(0.4
|
)
|
|
$
|
2.7
|
|
|
>100.0
|
%
|
|
Year Ended December 31,
|
|
|
|
|
|||||||||
|
2015
|
|
2014
|
|
$ Change
|
|
% Change
|
|||||||
|
($ in millions)
|
|
|
|
|
|||||||||
Product sales, net:
|
|
|
|
|
|
|
|
|||||||
FUSILEV
|
$
|
60.7
|
|
|
$
|
105.6
|
|
|
$
|
(44.9
|
)
|
|
(42.5
|
)%
|
FOLOTYN
|
40.6
|
|
|
47.6
|
|
|
(7.0
|
)
|
|
(14.7
|
)%
|
|||
ZEVALIN
|
17.5
|
|
|
22.1
|
|
|
(4.6
|
)
|
|
(20.8
|
)%
|
|||
MARQIBO
|
8.0
|
|
|
6.3
|
|
|
1.7
|
|
|
27.0
|
%
|
|||
BELEODAQ
|
10.1
|
|
|
4.9
|
|
|
5.2
|
|
|
>100.0
|
%
|
|||
|
136.9
|
|
|
186.5
|
|
|
(49.6
|
)
|
|
(26.6
|
)%
|
|||
License fees and service revenue
|
25.7
|
|
|
0.3
|
|
|
25.4
|
|
|
>100.0
|
%
|
|||
Total revenues
|
$
|
162.6
|
|
|
$
|
186.8
|
|
|
$
|
(24.2
|
)
|
|
(13.0
|
)%
|
|
Year Ended December 31,
|
|
|
|
|
|||||||||
|
2015
|
|
2014
|
|
$ Change
|
|
% Change
|
|||||||
|
($ in millions)
|
|
|
|
|
|||||||||
Operating expenses:
|
|
|
|
|
|
|
|
|||||||
Cost of product sales (excludes amortization and impairment of intangible assets)
|
$
|
27.7
|
|
|
$
|
27.0
|
|
|
$
|
0.7
|
|
|
2.6
|
%
|
Selling, general and administrative
|
86.5
|
|
|
97.4
|
|
|
(10.9
|
)
|
|
(11.2
|
)%
|
|||
Research and development
|
50.8
|
|
|
69.7
|
|
|
(18.9
|
)
|
|
(27.1
|
)%
|
|||
Amortization and impairment of intangible assets
|
38.3
|
|
|
24.3
|
|
|
14.0
|
|
|
57.6
|
%
|
|||
Total operating costs and expenses
|
$
|
203.3
|
|
|
$
|
218.4
|
|
|
$
|
(15.1
|
)
|
|
(6.9
|
)%
|
|
Year Ended December 31,
|
|
|
|
|
|||||||||
|
2015
|
|
2014
|
|
$ Change
|
|
% Change
|
|||||||
|
($ in millions)
|
|
|
|
|
|||||||||
Total other expense
|
$
|
(9.6
|
)
|
|
$
|
(12.0
|
)
|
|
$
|
2.4
|
|
|
20.0
|
%
|
|
Year Ended December 31,
|
|
|
|
|
|||||||||
|
2015
|
|
2014
|
|
$ Change
|
|
% Change
|
|||||||
|
($ in millions)
|
|
|
|
|
|||||||||
Provision for income taxes
|
$
|
(0.4
|
)
|
|
$
|
(2.2
|
)
|
|
$
|
1.8
|
|
|
81.8
|
%
|
|
December 31,
|
||||||
|
2016
|
|
2015
|
||||
|
(in thousands, except financial
metrics data) |
||||||
Cash, cash equivalents and marketable securities
|
$
|
158,469
|
|
|
$
|
139,986
|
|
Accounts receivable, net
|
$
|
39,782
|
|
|
$
|
30,384
|
|
Total current assets
|
$
|
216,650
|
|
|
$
|
190,625
|
|
Total current liabilities
|
$
|
65,513
|
|
|
$
|
76,343
|
|
Working capital surplus (a)
|
$
|
151,137
|
|
|
$
|
114,282
|
|
Current ratio (b)
|
3.3
|
|
|
2.5
|
|
(a)
|
Total current assets at period end
minus
total current liabilities at period end.
|
(b)
|
Total current assets at period end
divided by
total current liabilities at period end.
|
•
|
the need for additional capital to fund future development programs;
|
•
|
the need for additional capital to fund strategic acquisitions;
|
•
|
the need for additional capital to fund licensing arrangements;
|
•
|
our requirement for additional information technology infrastructure and systems; and
|
•
|
adverse outcomes from potential litigation and the cost to defend such litigation.
|
|
Total
|
|
Less than
1 Year |
|
1-3 Years
|
|
3-5 Years
|
|
After
5 Years |
||||||||||
|
(in thousands)
|
||||||||||||||||||
Operating lease obligations (1)
|
$
|
2,841
|
|
|
$
|
1,172
|
|
|
$
|
1,669
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Purchase obligations (2)
|
37,372
|
|
|
26,504
|
|
|
10,349
|
|
|
489
|
|
|
30
|
|
|||||
Contingent milestone obligations (3)
|
1,187,412
|
|
|
—
|
|
|
27,900
|
|
|
15,000
|
|
|
1,144,512
|
|
|||||
Drug development liability (4)
|
13,130
|
|
|
861
|
|
|
5,777
|
|
|
6,492
|
|
|
—
|
|
|||||
Debt obligations (5)
|
115,955
|
|
|
3,026
|
|
|
112,929
|
|
|
—
|
|
|
—
|
|
|||||
Total
|
$
|
1,356,710
|
|
|
$
|
31,563
|
|
|
$
|
158,624
|
|
|
$
|
21,981
|
|
|
$
|
1,144,542
|
|
(1)
|
The operating lease obligations are primarily related to the facility lease for our corporate headquarters in Henderson, Nevada, expiring April 30, 2019; and our research and development and administrative facility in Irvine, California, expiring May 31, 2019.
|
(2)
|
Purchase obligations represent the amount of open purchase orders and contractual commitments to vendors for products and services that have not been delivered, or rendered, as of
December 31, 2016
.
|
(3)
|
Milestone obligations are payable contingent upon successfully reaching certain development and regulatory milestones. Given the unpredictability of the drug development process, and the impossibility of predicting the success of current and future clinical trials, these values assume that all development and regulatory milestones under all of our license agreements are successfully met, and represent our best estimate of each achievement date. In the event that the milestones are met, we believe it is likely that the increase in the potential value of the related drug product will exceed the amount of the milestone obligation.
|
(4)
|
Research and development services under the Mundipharma Collaboration Agreement (see
Note 16
to the accompanying Consolidated Financial Statements) over the period required to complete the jointly agreed-upon clinical development activities.
|
(5)
|
Debt obligations represent amounts due under our 2018 Convertible Notes issued in December 2013, inclusive of interest payments over its full term (see
Note 15
to the accompanying Consolidated Financial Statements).
|
Spectrum Pharmaceuticals, Inc.
|
||
|
|
|
By:
|
|
/s/ R
AJESH
C. S
HROTRIYA
, M.D.
|
|
|
Rajesh C. Shrotriya, M.D.
|
|
|
Chairman of the Board and Chief Executive Officer
|
Signature
|
Title
|
Dates
|
|
|
|
/s/ RAJESH C. SHROTRIYA, M.D.
|
Chairman of the Board and Chief Executive Officer
|
March 14, 2017
|
Rajesh C. Shrotriya, M.D.
|
|
|
|
|
|
/s/ KURT A. GUSTAFSON
|
Executive Vice President and Chief Financial Officer
|
March 14, 2017
|
Kurt A. Gustafson
|
|
|
|
|
|
/s/ DOLOTRAI M. VYAS, PH.D.
|
Director
|
March 14, 2017
|
Dolatrai M. Vyas, Ph.D.
|
|
|
|
|
|
/s/ LUIGI LENAZ, M.D.
|
Lead Director
|
March 14, 2017
|
Luigi Lenaz, M.D.
|
|
|
|
|
|
/s/ STUART M. KRASSNER, SC.D., PSY.D
|
Director
|
March 14, 2017
|
Stuart M. Krassner, Sc.D., Psy.D.
|
|
|
|
|
|
/s/ ANTHONY E. MAIDA, III, M.A., M.B.A., PH.D.
|
Director
|
March 14, 2017
|
Anthony E. Maida, III, M.A., M.B.A., Ph.D.
|
|
|
|
|
|
/s/ RAYMOND W. COHEN
|
Director
|
March 14, 2017
|
Raymond W. Cohen
|
|
|
|
|
|
/s/ GILLES GAGNON, M.Sc., M.B.A
|
Director
|
March 14, 2017
|
Gilles Gagnon, M.Sc., M.B.A
|
|
|
|
|
|
|
|
Page
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
|
December 31,
|
||||||
|
2016
|
|
2015
|
||||
ASSETS
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
158,222
|
|
|
$
|
139,741
|
|
Marketable securities
|
247
|
|
|
245
|
|
||
Accounts receivable, net of allowance for doubtful accounts of $88 and $120, respectively
|
39,782
|
|
|
30,384
|
|
||
Other receivables
|
5,754
|
|
|
12,572
|
|
||
Inventories
|
8,715
|
|
|
4,176
|
|
||
Prepaid expenses and other assets
|
3,930
|
|
|
3,507
|
|
||
Total current assets
|
216,650
|
|
|
190,625
|
|
||
Property and equipment, net of accumulated depreciation
|
449
|
|
|
918
|
|
||
Intangible assets, net of accumulated amortization and impairment charges
|
164,234
|
|
|
190,335
|
|
||
Goodwill
|
17,886
|
|
|
17,960
|
|
||
Other assets
|
29,549
|
|
|
19,211
|
|
||
Total assets
|
$
|
428,768
|
|
|
$
|
419,049
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
|
|
|
||||
Current liabilities:
|
|
|
|
||||
Accounts payable and other accrued liabilities
|
$
|
52,483
|
|
|
$
|
56,539
|
|
Accrued payroll and benefits
|
8,981
|
|
|
8,188
|
|
||
Deferred revenue
|
3,188
|
|
|
6,130
|
|
||
Drug development liability
|
861
|
|
|
259
|
|
||
Acquisition-related contingent obligations
|
—
|
|
|
5,227
|
|
||
Total current liabilities
|
65,513
|
|
|
76,343
|
|
||
Drug development liability, less current portion
|
12,269
|
|
|
14,427
|
|
||
Deferred revenue, less current portion
|
323
|
|
|
383
|
|
||
Acquisition-related contingent obligations, less current portion
|
1,315
|
|
|
1,439
|
|
||
Deferred tax liabilities
|
6,675
|
|
|
6,779
|
|
||
Other long-term liabilities
|
9,604
|
|
|
7,444
|
|
||
Convertible senior notes
|
97,043
|
|
|
99,377
|
|
||
Total liabilities
|
192,742
|
|
|
206,192
|
|
||
Commitments and contingencies
|
|
|
|
||||
Stockholders’ equity:
|
|
|
|
||||
Preferred stock, $0.001 par value; 5,000,000 shares authorized; no shares issued and outstanding
|
—
|
|
|
—
|
|
||
Series B Junior Participating Preferred Stock, $0.001 par value; 1,500,000 shares authorized; no shares issued and outstanding
|
—
|
|
|
—
|
|
||
Series E Convertible Voting Preferred Stock, $0.001 par value and $10,000 stated value; 2,000 shares authorized; 0 and 20 shares issued and outstanding at December 31, 2016 and 2015, respectively (the presented 2015 balance relates to 20 shares of preferred stock which were converted into 40,000 shares of common stock in 2016)
|
—
|
|
|
123
|
|
||
Common stock, $0.001 par value; 175,000,000 shares authorized; 80,466,735 and 68,228,935 issued and outstanding at December 31, 2016 and 2015, respectively
|
80
|
|
|
68
|
|
||
Additional paid-in capital
|
640,166
|
|
|
552,108
|
|
||
Accumulated other comprehensive loss
|
(1,579
|
)
|
|
(5,319
|
)
|
||
Accumulated deficit
|
(402,641
|
)
|
|
(334,123
|
)
|
||
Total stockholders’ equity
|
236,026
|
|
|
212,857
|
|
||
Total liabilities and stockholders’ equity
|
$
|
428,768
|
|
|
$
|
419,049
|
|
|
Year Ended December 31,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
Revenues:
|
|
|
|
|
|
||||||
Product sales, net
|
$
|
128,596
|
|
|
$
|
136,851
|
|
|
$
|
186,537
|
|
License fees and service revenue
|
17,848
|
|
|
25,705
|
|
|
293
|
|
|||
Total revenues
|
146,444
|
|
|
162,556
|
|
|
186,830
|
|
|||
Operating costs and expenses:
|
|
|
|
|
|
||||||
Cost of product sales (excludes amortization and impairment charges of intangible assets)
|
27,953
|
|
|
27,689
|
|
|
27,037
|
|
|||
Cost of service revenue
|
7,890
|
|
|
—
|
|
|
—
|
|
|||
Selling, general and administrative
|
87,347
|
|
|
86,514
|
|
|
97,412
|
|
|||
Research and development
|
58,936
|
|
|
50,766
|
|
|
69,662
|
|
|||
Amortization and impairment charges of intangible assets
|
25,946
|
|
|
38,319
|
|
|
24,288
|
|
|||
Total operating costs and expenses
|
208,072
|
|
|
203,288
|
|
|
218,399
|
|
|||
Loss from operations
|
(61,628
|
)
|
|
(40,732
|
)
|
|
(31,569
|
)
|
|||
Other (expense) income:
|
|
|
|
|
|
||||||
Interest expense, net
|
(9,435
|
)
|
|
(9,074
|
)
|
|
(8,584
|
)
|
|||
Change in fair value of contingent consideration related to acquisitions
|
(649
|
)
|
|
676
|
|
|
987
|
|
|||
Other income (expense), net
|
887
|
|
|
(1,249
|
)
|
|
(4,367
|
)
|
|||
Total other expenses
|
(9,197
|
)
|
|
(9,647
|
)
|
|
(11,964
|
)
|
|||
Loss before income taxes
|
(70,825
|
)
|
|
(50,379
|
)
|
|
(43,533
|
)
|
|||
Benefit (provision) for income taxes
|
2,313
|
|
|
(406
|
)
|
|
(2,186
|
)
|
|||
Net loss
|
$
|
(68,512
|
)
|
|
$
|
(50,785
|
)
|
|
$
|
(45,719
|
)
|
Net loss per share:
|
|
|
|
|
|
||||||
Basic
|
$
|
(0.94
|
)
|
|
$
|
(0.78
|
)
|
|
$
|
(0.71
|
)
|
Diluted
|
$
|
(0.94
|
)
|
|
$
|
(0.78
|
)
|
|
$
|
(0.71
|
)
|
Weighted average shares outstanding:
|
|
|
|
|
|
||||||
Basic
|
72,824,070
|
|
|
64,882,417
|
|
|
64,708,163
|
|
|||
Diluted
|
72,824,070
|
|
|
64,882,417
|
|
|
64,708,163
|
|
|
Year Ended December 31,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
Net loss
|
$
|
(68,512
|
)
|
|
$
|
(50,785
|
)
|
|
$
|
(45,719
|
)
|
Other comprehensive income (loss):
|
|
|
|
|
|
||||||
Unrealized gain (loss) on available-for-sale securities, net of income tax of $2.2 million, $0, and $0 for years ended December 31, 2016, 2015, and 2014, respectively
|
4,185
|
|
|
(1,429
|
)
|
|
(1,122
|
)
|
|||
Foreign currency translation adjustments
|
(445
|
)
|
|
(3,040
|
)
|
|
1,595
|
|
|||
Adjustment for realized gain on available-for-sale securities, and included in net income
|
—
|
|
|
—
|
|
|
(2,217
|
)
|
|||
Other comprehensive income (loss)
|
3,740
|
|
|
(4,469
|
)
|
|
(1,744
|
)
|
|||
Total comprehensive loss
|
$
|
(64,772
|
)
|
|
$
|
(55,254
|
)
|
|
$
|
(47,463
|
)
|
|
Preferred Stock
|
|
Common Stock
|
|
Additional Paid-In Capital
|
|
Accumulated
Other Comprehensive Income (Loss)
|
|
Accumulated Deficit
|
|
Treasury Stock
|
|
Total
Stockholders' Equity
|
|||||||||||||||||||||||
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
|
|
|
Shares
|
|
Amount
|
|
|||||||||||||||||||||
Balance as of December 31, 2013
|
20
|
|
|
$
|
123
|
|
|
64,104,173
|
|
|
$
|
64
|
|
|
$
|
518,144
|
|
|
$
|
894
|
|
|
$
|
(237,619
|
)
|
|
—
|
|
|
$
|
—
|
|
|
$
|
281,606
|
|
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(45,719
|
)
|
|
—
|
|
|
—
|
|
|
(45,719
|
)
|
|||||||
Other comprehensive loss, net
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(1,744
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(1,744
|
)
|
|||||||
Issuance of common stock to 401(k) plan
|
—
|
|
|
—
|
|
|
133,734
|
|
|
—
|
|
|
1,028
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,028
|
|
|||||||
Issuance of common stock for ESPP
|
—
|
|
|
—
|
|
|
99,551
|
|
|
—
|
|
|
639
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
639
|
|
|||||||
Issuance of common stock upon exercise of stock options
|
—
|
|
|
—
|
|
|
485,260
|
|
|
1
|
|
|
1,905
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,906
|
|
|||||||
RSA issuances and forfeitures for terminations, net
|
—
|
|
|
—
|
|
|
396,083
|
|
|
—
|
|
|
10,781
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
10,781
|
|
|||||||
Purchase/retirement of RSAs to satisfy employee tax withholding
|
—
|
|
|
—
|
|
|
(249,102
|
)
|
|
|
|
|
(1,733
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(1,733
|
)
|
|||||||
Issuance of common stock for BELEODAQ milestone achievement
|
—
|
|
|
—
|
|
|
1,000,000
|
|
|
1
|
|
|
7,789
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
7,790
|
|
|||||||
Balance as of December 31, 2014
|
20
|
|
|
$
|
123
|
|
|
65,969,699
|
|
|
$
|
66
|
|
|
$
|
538,553
|
|
|
$
|
(850
|
)
|
|
$
|
(283,338
|
)
|
|
—
|
|
|
$
|
—
|
|
|
$
|
254,554
|
|
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(50,785
|
)
|
|
—
|
|
|
—
|
|
|
(50,785
|
)
|
|||||||
Other comprehensive loss, net
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(4,469
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(4,469
|
)
|
|||||||
Issuance of common stock to 401(k) plan
|
—
|
|
|
—
|
|
|
179,865
|
|
|
—
|
|
|
1,124
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,124
|
|
|||||||
Issuance of common stock for ESPP
|
—
|
|
|
—
|
|
|
114,578
|
|
|
—
|
|
|
627
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
627
|
|
|||||||
Issuance of common stock upon exercise of stock options
|
—
|
|
|
—
|
|
|
456,082
|
|
|
—
|
|
|
1,482
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,482
|
|
|||||||
Warrant modification
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
568
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
568
|
|
|||||||
RSA issuances and forfeitures for terminations, net
|
—
|
|
|
—
|
|
|
1,613,553
|
|
|
2
|
|
|
10,392
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
10,394
|
|
|||||||
Purchase/retirement of RSAs to satisfy employee tax withholding
|
—
|
|
|
—
|
|
|
(104,842
|
)
|
|
|
|
|
(638
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(638
|
)
|
|||||||
Balance as of December 31, 2015
|
20
|
|
|
$
|
123
|
|
|
68,228,935
|
|
|
$
|
68
|
|
|
$
|
552,108
|
|
|
$
|
(5,319
|
)
|
|
$
|
(334,123
|
)
|
|
—
|
|
|
$
|
—
|
|
|
$
|
212,857
|
|
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(68,512
|
)
|
|
—
|
|
|
—
|
|
|
(68,512
|
)
|
|||||||
Other comprehensive income, net
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
3,740
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
3,740
|
|
|||||||
Issuance of common stock to 401(k) plan
|
—
|
|
|
—
|
|
|
172,650
|
|
|
—
|
|
|
953
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
953
|
|
|||||||
Issuance of common stock for ESPP
|
—
|
|
|
—
|
|
|
150,303
|
|
|
—
|
|
|
668
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
668
|
|
|||||||
Issuance of common stock upon exercise of stock options
|
—
|
|
|
—
|
|
|
39,010
|
|
|
—
|
|
|
202
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
202
|
|
|||||||
RSA issuances and forfeitures for terminations, net
|
—
|
|
|
—
|
|
|
868,032
|
|
|
1
|
|
|
11,459
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
11,460
|
|
|||||||
Purchase/retirement of RSAs to satisfy employee tax withholding
|
—
|
|
|
—
|
|
|
(266,860
|
)
|
|
—
|
|
|
(1,397
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(1,397
|
)
|
|||||||
Common stock issued under an at-market-issuance sales agreement (
Note 7
)
|
—
|
|
|
—
|
|
|
10,890,915
|
|
|
11
|
|
|
73,858
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
73,869
|
|
|||||||
Issuance of common stock for ROLONTIS milestone achievement (
Note 17(b)(xii)
)
|
—
|
|
|
—
|
|
|
318,750
|
|
|
—
|
|
|
2,308
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2,308
|
|
|||||||
Issuance of common stock for QAPZOLA milestone achievement (
Note 17(b)(ix)
)
|
—
|
|
|
—
|
|
|
25,000
|
|
|
—
|
|
|
111
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
111
|
|
|||||||
Conversion hedge unwind in connection with open market purchases of 2018 Convertible Notes (
Note 15
)
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(227
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(227
|
)
|
|||||||
Dividend paid on preferred shares (
Note 7
)
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(6
|
)
|
|
—
|
|
|
—
|
|
|
(6
|
)
|
|||||||
Conversion of preferred shares into common stock (
Note 7
)
|
(20
|
)
|
|
(123
|
)
|
|
40,000
|
|
|
—
|
|
|
123
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||||
Balance as of December 31, 2016
|
—
|
|
|
$
|
—
|
|
|
80,466,735
|
|
|
$
|
80
|
|
|
$
|
640,166
|
|
|
$
|
(1,579
|
)
|
|
$
|
(402,641
|
)
|
|
—
|
|
|
$
|
—
|
|
|
$
|
236,026
|
|
|
Year Ended December 31,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
Cash Flows From Operating Activities:
|
|
|
|
|
|
||||||
Net loss
|
$
|
(68,512
|
)
|
|
$
|
(50,785
|
)
|
|
$
|
(45,719
|
)
|
Adjustments to reconcile net loss to net cash (used in) provided by operating activities:
|
|
|
|
|
|
||||||
Depreciation and amortization
|
26,492
|
|
|
31,869
|
|
|
25,352
|
|
|||
Stock-based compensation
|
12,412
|
|
|
12,084
|
|
|
11,809
|
|
|||
Accretion of debt discount, recorded to interest expense on 2018 Convertible Notes (
Note 15
)
|
5,710
|
|
|
5,250
|
|
|
4,818
|
|
|||
Amortization of deferred financing costs, recorded to interest expense on 2018 Convertible Notes (
Note 15
)
|
696
|
|
|
662
|
|
|
599
|
|
|||
Bad debt expense (recovery)
|
57
|
|
|
—
|
|
|
(85
|
)
|
|||
Unrealized foreign currency exchange (gain) loss
|
(153
|
)
|
|
(157
|
)
|
|
6,033
|
|
|||
Loss on 2018 Convertible Note purchase (
Note 15
)
|
25
|
|
|
—
|
|
|
—
|
|
|||
Change in cash surrender value of corporate owned life insurance
|
(137
|
)
|
|
—
|
|
|
—
|
|
|||
Income tax recognition on unrealized gain on available-for-sale securities
|
(2,217
|
)
|
|
—
|
|
|
—
|
|
|||
Impairment of intangible assets (
Note 3(g)
)
|
—
|
|
|
7,160
|
|
|
—
|
|
|||
Change in fair value of contingent consideration related to the EVOMELA and Talon acquisitions (
Note 10
)
|
649
|
|
|
(676
|
)
|
|
(987
|
)
|
|||
Research and development expense recognized for the value of common stock issued in connection with ROLONTIS and QAPZOLA milestone achievements (
Note 17(b)(ix)
and
(xii)
)
|
2,419
|
|
|
—
|
|
|
—
|
|
|||
Research and development expense for the value of common stock issued in connection with BELEODAQ milestone achievement (
Note 17(b)(xi)
)
|
—
|
|
|
—
|
|
|
7,790
|
|
|||
Changes in operating assets and liabilities:
|
|
|
|
|
|
||||||
Accounts receivable, net
|
(9,494
|
)
|
|
40,245
|
|
|
(21,671
|
)
|
|||
Other receivables
|
6,895
|
|
|
(7,017
|
)
|
|
2,070
|
|
|||
Inventories
|
(5,800
|
)
|
|
1,863
|
|
|
4,253
|
|
|||
Prepaid expenses
|
(423
|
)
|
|
(446
|
)
|
|
(718
|
)
|
|||
Deferred tax assets
|
—
|
|
|
—
|
|
|
1,724
|
|
|||
Other assets
|
(2,043
|
)
|
|
(1,731
|
)
|
|
(13,161
|
)
|
|||
Accounts payable and other accrued obligations
|
(4,033
|
)
|
|
(28,298
|
)
|
|
5,304
|
|
|||
Accrued payroll and benefits
|
790
|
|
|
(233
|
)
|
|
1,594
|
|
|||
Drug development liability
|
(1,556
|
)
|
|
(1,100
|
)
|
|
(1,957
|
)
|
|||
Acquisition-related contingent obligations
|
(1,300
|
)
|
|
—
|
|
|
—
|
|
|||
Deferred revenue
|
(2,985
|
)
|
|
(3,511
|
)
|
|
9,803
|
|
|||
Deferred tax liabilities
|
(104
|
)
|
|
210
|
|
|
(602
|
)
|
|||
Other long-term liabilities
|
2,153
|
|
|
1,355
|
|
|
124
|
|
|||
Net cash (used in) provided by operating activities
|
(40,459
|
)
|
|
6,744
|
|
|
(3,627
|
)
|
|||
Cash Flows From Investing Activities:
|
|
|
|
|
|
||||||
Purchases of property and equipment
|
(78
|
)
|
|
(223
|
)
|
|
(934
|
)
|
|||
Payment for corporate-owned life insurance premiums
|
(601
|
)
|
|
—
|
|
|
—
|
|
|||
Proceeds from sale of available-for-sale securities
|
—
|
|
|
3,061
|
|
|
4,093
|
|
|||
Capitalized cash milestone payment upon FDA approval of BELEODAQ
|
—
|
|
|
—
|
|
|
(25,000
|
)
|
|||
Net cash (used in) provided by investing activities
|
(679
|
)
|
|
2,838
|
|
|
(21,841
|
)
|
|||
Cash Flows From Financing Activities:
|
|
|
|
|
|
||||||
Proceeds from exercise of stock options
|
203
|
|
|
1,482
|
|
|
1,906
|
|
|||
Proceeds from sale of stock under employee stock purchase plan
|
668
|
|
|
627
|
|
|
639
|
|
|||
Purchase and retirement of restricted stock to satisfy employees' tax liability at vesting
|
(1,397
|
)
|
|
(638
|
)
|
|
(1,733
|
)
|
|||
Payment of contingent consideration related to EVOMELA acquisition (
Note 10(b)
)
|
(4,700
|
)
|
|
—
|
|
|
—
|
|
|||
Proceeds from common stock sold under an at-market-issuance sales agreement (
Note 7
)
|
73,869
|
|
|
—
|
|
|
—
|
|
|||
Purchase of 2018 Convertible Notes (
Note 15
)
|
(9,014
|
)
|
|
—
|
|
|
—
|
|
|||
Purchase of warrants related to the conversion hedge of 2018 Convertible Notes (
Note 15
)
|
(330
|
)
|
|
—
|
|
|
—
|
|
|||
Proceeds from sale of call options related to the conversion hedge of 2018 Convertible Notes (
Note 15
)
|
351
|
|
|
—
|
|
|
—
|
|
|||
Dividends paid upon conversion of Series E Convertible Voting Preferred Stock (
Note 7
)
|
(6
|
)
|
|
—
|
|
|
—
|
|
|||
Net cash provided by financing activities
|
59,644
|
|
|
1,471
|
|
|
812
|
|
|||
Effect of exchange rates on cash and equivalents
|
(25
|
)
|
|
(1,254
|
)
|
|
(1,708
|
)
|
|||
Net increase (decrease) in cash and equivalents
|
18,481
|
|
|
9,799
|
|
|
(26,364
|
)
|
|||
Cash and equivalents — beginning of year
|
139,741
|
|
|
129,942
|
|
|
156,306
|
|
|||
Cash and equivalents — end of year
|
$
|
158,222
|
|
|
$
|
139,741
|
|
|
$
|
129,942
|
|
Supplemental Disclosure of Cash Flow Information:
|
|
|
|
|
|
||||||
Cash paid for income taxes
|
$
|
11
|
|
|
$
|
335
|
|
|
$
|
329
|
|
Cash paid for interest
|
$
|
3,300
|
|
|
$
|
3,300
|
|
|
$
|
3,227
|
|
•
|
ROLONTIS (formerly referred to as SPI-2012 or LAPS-G-CSF) for chemotherapy-induced neutropenia.
|
•
|
QAPZOLA (previously referred to as APAZIQUONE) for immediate intravesical instillation in post-transurethral resection of bladder tumors in patients with non-muscle invasive bladder cancer, or NMIBC.
|
•
|
POZIOTINIB, a novel pan-HER inhibitor used in the treatment of patients with a variety of solid tumors, including breast and lung cancer.
|
(1)
|
appropriate evidence of a binding arrangement exists with our customer;
|
(2)
|
price is substantially fixed or determinable;
|
(3)
|
collection from our customer is reasonably assured;
|
(4)
|
our customer’s obligation to pay us is not contingent on resale of the product;
|
(5)
|
we do not have significant continued performance obligations to our customer; and
|
(6)
|
we have a reasonable basis to estimate returns.
|
(i)
|
We first assess the number of “units of accounting” for the elements in our out-license arrangements in accordance with multiple element arrangement guidance. We consider if elements (deliverables) have standalone value, and if standalone value does not exist for a deliverable, it is combined (as applicable) with other deliverables until the "bundle" has standalone value (as a single unit of accounting).
|
(ii)
|
Next, we allocate arrangement consideration among the separate units of accounting (using the "relative selling price method").
|
(iii)
|
Finally, we evaluate the timing of revenue recognition, which is impacted by the nature of the consideration to which we are entitled, as follows:
|
(a)
|
Upfront license fees
: We consider whether upfront license fees are earned (i.e., realized) at the time of contract execution (i.e., when the license rights transfer to the customer). We give specific consideration to whether we have any on-going contractual service obligations to the licensee, including any requirements for us to provide on-going support services, and/or for us to supply drug products for the licensee’s future sales. As a result, we may either recognize all upfront license fees as revenue in the period of contract execution, or recognize these fees over the actual (or implied) contractual term of the out-license.
|
(b)
|
Royalties
: We recognize revenue in the period that our licensees report product sales to us in their territory for which we are contractually entitled to a percentage-based royalty receipt (i.e., representing the period when earned and realizable).
|
(c)
|
Sales milestones
: We recognize revenue in the period that our licensees report achievement of annual or aggregate product sales levels in their territories for which we are contractually entitled to a specified lump-sum receipt (i.e., representing the period when earned and realizable).
|
(d)
|
Regulatory milestones
: Under the terms of the respective out-license, regulatory achievements may either be our responsibility, or that of our licensee.
|
|
Cost
|
|
Gross
Unrealized Gains |
|
Gross
Unrealized Losses |
|
Estimated
fair Value |
|
Cash and
equivalents |
|
Marketable Securities
|
||||||||||||||||
|
Current
|
|
Long
Term |
||||||||||||||||||||||||
December 31, 2016
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
Bank deposits
|
$
|
23,915
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
23,915
|
|
|
$
|
23,915
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Money market funds
|
128,563
|
|
|
—
|
|
|
—
|
|
|
128,563
|
|
|
128,563
|
|
|
—
|
|
|
—
|
|
|||||||
Bank certificate of deposits
|
5,991
|
|
|
—
|
|
|
—
|
|
|
5,991
|
|
|
5,744
|
|
|
247
|
|
|
—
|
|
|||||||
Total cash and equivalents and marketable securities
|
$
|
158,469
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
158,469
|
|
|
$
|
158,222
|
|
|
$
|
247
|
|
|
$
|
—
|
|
December 31, 2015
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
Bank deposits
|
$
|
59,625
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
59,625
|
|
|
$
|
59,625
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Money market funds
|
80,116
|
|
|
—
|
|
|
—
|
|
|
80,116
|
|
|
80,116
|
|
|
—
|
|
|
—
|
|
|||||||
Bank certificate of deposits
|
245
|
|
|
—
|
|
|
—
|
|
|
245
|
|
|
—
|
|
|
245
|
|
|
—
|
|
|||||||
Total cash and equivalents and marketable securities
|
$
|
139,986
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
139,986
|
|
|
$
|
139,741
|
|
|
$
|
245
|
|
|
$
|
—
|
|
|
December 31,
|
||||||
|
2016
|
|
2015
|
||||
Computers hardware and software
|
$
|
2,550
|
|
|
$
|
3,785
|
|
Laboratory equipment
|
622
|
|
|
608
|
|
||
Office furniture
|
211
|
|
|
355
|
|
||
Leasehold improvements
|
2,912
|
|
|
2,872
|
|
||
Property and equipment, at cost
|
6,295
|
|
|
7,620
|
|
||
(Less): Accumulated depreciation
|
(5,846
|
)
|
|
(6,702
|
)
|
||
Property and equipment, net of accumulated depreciation
|
$
|
449
|
|
|
$
|
918
|
|
|
December 31,
|
||||||
|
2016
|
|
2015
|
||||
Raw materials
|
$
|
2,991
|
|
|
$
|
1,606
|
|
Work in process*
|
7,838
|
|
|
4,228
|
|
||
Finished goods
|
2,305
|
|
|
1,498
|
|
||
(Less:) Non-current portion of inventories included within "other assets" **
|
(4,419
|
)
|
|
(3,156
|
)
|
||
Inventories
|
$
|
8,715
|
|
|
$
|
4,176
|
|
|
Year Ended December 31,
|
||||||||||||
|
2016
|
|
2015
|
||||||||||
McKesson Corporation and its affiliates
|
$
|
10,395
|
|
|
26.1
|
%
|
|
$
|
20,281
|
|
|
66.7
|
%
|
Cardinal Health, Inc. and its affiliates
|
13,147
|
|
|
33.0
|
%
|
|
7,241
|
|
|
23.8
|
%
|
||
AmerisourceBergen Corporation, and its affiliates
|
13,470
|
|
|
33.9
|
%
|
|
*
|
|
|
—
|
%
|
||
All other customers
|
2,770
|
|
|
7.0
|
%
|
|
2,862
|
|
|
9.4
|
%
|
||
Total Accounts Receivables, net
|
$
|
39,782
|
|
|
100.0
|
%
|
|
$
|
30,384
|
|
|
100.0
|
%
|
*
|
Less than
10%
|
|
December 31,
|
||||||
|
2016
|
|
2015
|
||||
Prepaid operating expenses
|
$
|
3,930
|
|
|
$
|
3,507
|
|
Current portion of debt issuance costs*
|
—
|
|
|
—
|
|
||
Prepaid expenses and other assets
|
$
|
3,930
|
|
|
$
|
3,507
|
|
|
December 31,
|
||||||
|
2016
|
|
2015
|
||||
Income tax receivable
|
$
|
1,388
|
|
|
$
|
1,301
|
|
Insurance receivable
|
500
|
|
|
7,100
|
|
||
Promissory note related to ZEVALIN out-license (
Note 12
)
|
—
|
|
|
2,215
|
|
||
Receivable for contracted sales and marketing services (
Note 14
)
|
1,831
|
|
|
—
|
|
||
Reimbursements due from development partners for incurred research and development expenses
|
1,796
|
|
|
1,699
|
|
||
Other miscellaneous receivables
|
239
|
|
|
257
|
|
||
Other receivables
|
$
|
5,754
|
|
|
$
|
12,572
|
|
|
|
|
December 31, 2016
|
||||||||||||||||||||
|
Historical
Cost |
|
Accumulated
Amortization |
|
Foreign
Currency Translation |
|
Impairment
|
|
Net Amount
|
|
Full
Amortization Period (months) |
|
Remaining
Amortization Period (months) |
||||||||||
MARQIBO IPR&D (NHL and other novel indications)
|
$
|
17,600
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
17,600
|
|
|
n/a
|
|
n/a
|
EVOMELA distribution rights (1)
|
7,700
|
|
|
(444
|
)
|
|
—
|
|
|
—
|
|
|
7,256
|
|
|
156
|
|
147
|
|||||
BELEODAQ distribution rights
|
25,000
|
|
|
(4,688
|
)
|
|
—
|
|
|
—
|
|
|
20,312
|
|
|
160
|
|
130
|
|||||
MARQIBO distribution rights
|
26,900
|
|
|
(12,863
|
)
|
|
—
|
|
|
—
|
|
|
14,037
|
|
|
81
|
|
39
|
|||||
FOLOTYN distribution rights (2)
|
118,400
|
|
|
(41,036
|
)
|
|
—
|
|
|
—
|
|
|
77,364
|
|
|
152
|
|
71
|
|||||
ZEVALIN distribution rights – U.S.
|
41,900
|
|
|
(34,083
|
)
|
|
—
|
|
|
—
|
|
|
7,817
|
|
|
123
|
|
27
|
|||||
ZEVALIN distribution rights – Ex-U.S.
|
23,490
|
|
|
(13,649
|
)
|
|
(5,038
|
)
|
|
—
|
|
|
4,803
|
|
|
96
|
|
39
|
|||||
FUSILEV distribution rights (3)
|
16,778
|
|
|
(9,618
|
)
|
|
—
|
|
|
(7,160
|
)
|
|
—
|
|
|
56
|
|
0
|
|||||
FOLOTYN out-license (4)
|
27,900
|
|
|
(11,832
|
)
|
|
—
|
|
|
(1,023
|
)
|
|
15,045
|
|
|
110
|
|
67
|
|||||
Total intangible assets
|
$
|
305,668
|
|
|
$
|
(128,213
|
)
|
|
$
|
(5,038
|
)
|
|
$
|
(8,183
|
)
|
|
$
|
164,234
|
|
|
|
|
|
(1)
|
The FDA approval of EVOMELA in March 2016 triggered a
$6 million
payment due to CyDex Pharmaceuticals, Inc. (a wholly-owned subsidiary of Ligand Pharmaceuticals Incorporated ("Ligand")). This event also resulted in a reclassification of our
$7.7 million
"EVOMELA IPR&D" to "EVOMELA distribution rights" due to our ability to begin its commercialization with this FDA approval. Amortization commenced on April 1, 2016, in accordance with our capitalization policy for intangible assets.
|
(2)
|
Beginning June 2016, we adjusted the amortization period of our FOLOTYN distribution rights to November 2022 from March 2025, representing the period through which we expect to have patent protection from generic competition (see
Note 17(g)
).
|
(3)
|
On February 20, 2015, the U.S. District Court for the District of Nevada found the patent covering FUSILEV to be invalid, which was upheld on appeal. On April 24, 2015, Sandoz began to commercialize a generic version of FUSILEV. This represented a “triggering event” under applicable GAAP in evaluating the value of our FUSILEV distribution rights as of March 31, 2015, resulting in a
$7.2 million
impairment charge (non-cash) in the first quarter of 2015. We accelerated amortization expense recognition for the remaining net book value of FUSILEV distribution rights.
|
(4)
|
On May 29, 2013, we amended our FOLOTYN collaboration agreement with Mundipharma. As a result of the amendment, Europe and Turkey were excluded from Mundipharma’s commercialization territory, and their royalty rates and milestone payments to us were modified. This constituted a change under which we originally valued the FOLOTYN out-license as part of business combination accounting, resulting in an impairment charge (non-cash) of
$1.0 million
resulted from this amendment.
|
|
|
|
December 31, 2015
|
||||||||||||||||
|
Historical
Cost
|
|
Accumulated
Amortization
|
|
Foreign
Currency
Translation
|
|
Impairment
|
|
Net Amount
|
||||||||||
MARQIBO IPR&D (NHL and other novel indications)
|
$
|
17,600
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
17,600
|
|
EVOMELA IPR&D
|
7,700
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
7,700
|
|
|||||
BELEODAQ distribution rights
|
25,000
|
|
|
(2,812
|
)
|
|
—
|
|
|
—
|
|
|
22,188
|
|
|||||
MARQIBO distribution rights
|
26,900
|
|
|
(8,544
|
)
|
|
—
|
|
|
—
|
|
|
18,356
|
|
|||||
FOLOTYN distribution rights
|
118,400
|
|
|
(29,474
|
)
|
|
—
|
|
|
—
|
|
|
88,926
|
|
|||||
ZEVALIN distribution rights – U.S.
|
41,900
|
|
|
(30,608
|
)
|
|
—
|
|
|
—
|
|
|
11,292
|
|
|||||
ZEVALIN distribution rights – Ex-U.S.
|
23,490
|
|
|
(12,632
|
)
|
|
(4,353
|
)
|
|
—
|
|
|
6,505
|
|
|||||
FUSILEV distribution rights
|
16,778
|
|
|
(9,618
|
)
|
|
—
|
|
|
(7,160
|
)
|
|
—
|
|
|||||
FOLOTYN out-license
|
27,900
|
|
|
(9,109
|
)
|
|
—
|
|
|
(1,023
|
)
|
|
17,768
|
|
|||||
Total intangible assets
|
$
|
305,668
|
|
|
$
|
(102,797
|
)
|
|
$
|
(4,353
|
)
|
|
$
|
(8,183
|
)
|
|
$
|
190,335
|
|
|
December 31,
|
||||||
|
2016
|
|
2015
|
||||
Acquisition of Talon
|
$
|
10,526
|
|
|
$
|
10,526
|
|
Acquisition of ZEVALIN Ex-U.S. distribution rights
|
2,525
|
|
|
2,525
|
|
||
Acquisition of Allos
|
5,346
|
|
|
5,346
|
|
||
Foreign currency exchange translation effects
|
(511
|
)
|
|
(437
|
)
|
||
Goodwill
|
$
|
17,886
|
|
|
$
|
17,960
|
|
|
December 31,
|
||||||
|
2016
|
|
2015
|
||||
Equity securities (see
Note 11
)*
|
$
|
11,533
|
|
|
$
|
5,189
|
|
CASI note - long term (see
Note 11
)
|
1,510
|
|
|
1,500
|
|
||
Research & development supplies and other
|
224
|
|
|
185
|
|
||
2018 Convertible Notes issuance costs (excluding current portion)**
|
—
|
|
|
—
|
|
||
Executive officer life insurance – cash surrender value
|
11,863
|
|
|
9,181
|
|
||
Inventories - non-current portion
|
4,419
|
|
|
3,156
|
|
||
Other assets
|
$
|
29,549
|
|
|
$
|
19,211
|
|
|
December 31,
|
||||||
|
2016
|
|
2015
|
||||
Trade accounts payable and other accrued liabilities
|
$
|
30,488
|
|
|
$
|
26,684
|
|
Accrued rebates
|
8,350
|
|
|
18,166
|
|
||
Accrued product royalty
|
4,723
|
|
|
4,908
|
|
||
Allowance for returns
|
2,309
|
|
|
1,394
|
|
||
Accrued data and distribution fees
|
4,222
|
|
|
1,830
|
|
||
Accrued GPO administrative fees
|
384
|
|
|
1,058
|
|
||
Accrued inventory management fee
|
540
|
|
|
498
|
|
||
Allowance for chargebacks
|
1,467
|
|
|
2,001
|
|
||
Accounts payable and other accrued liabilities
|
$
|
52,483
|
|
|
$
|
56,539
|
|
Description
|
Rebates and
Chargebacks |
|
Data and
Distribution, GPO Fees, and Inventory Management Fees |
|
Returns
|
||||||
Balance as of December 31, 2014
|
$
|
45,822
|
|
|
$
|
8,284
|
|
|
$
|
1,135
|
|
Add: provisions
|
75,498
|
|
|
15,928
|
|
|
1,486
|
|
|||
(Less): credits or actual allowances
|
(101,153
|
)
|
|
(20,826
|
)
|
|
(1,227
|
)
|
|||
Balance as of December 31, 2015
|
20,167
|
|
|
3,386
|
|
|
1,394
|
|
|||
Add: provisions
|
98,317
|
|
|
14,979
|
|
|
2,123
|
|
|||
(Less): credits or actual allowances
|
(108,667
|
)
|
|
(13,219
|
)
|
|
(1,208
|
)
|
|||
Balance as of December 31, 2016
|
$
|
9,817
|
|
|
$
|
5,146
|
|
|
$
|
2,309
|
|
|
December 31,
|
||||||
|
2016
|
|
2015
|
||||
ZEVALIN out-license deferred revenue in Asia territory (see
Note 12
)
|
$
|
1,255
|
|
|
$
|
—
|
|
EVOMELA deferred revenue*
|
1,887
|
|
|
—
|
|
||
FUSILEV deferred revenue**
|
—
|
|
|
6,083
|
|
||
ZEVALIN out-license in India territory (see
Note 17(b)(iii)
)
|
369
|
|
|
430
|
|
||
Deferred revenue
|
$
|
3,511
|
|
|
$
|
6,513
|
|
*
|
We commercialized EVOMELA beginning in April 2016, and have deferred revenue recognition (see
Note 2(i)(a)
) for any product shipped to our distributors, but not ordered and received by end-users as of
December 31, 2016
. This deferral is a result of our inability to estimate future returns and rebates given the lack of historical data available with the recent launch of the product.
|
**
|
In the third quarter of 2015, we deferred revenue recognition related to certain FUSILEV product shipments that did not meet our revenue recognition criteria (see
Note 2(i)(a)
), aggregating
$9.9 million
. Specifically, this deferral is a result of our inability to estimate future rebate values (with requisite precision) offered to our customers in order to compete with generic products. During the fourth quarter of 2015, we recognized
$3.8 million
for these third quarter shipments, and
$6.1 million
remained deferred as of December 31, 2015.
|
|
December 31,
|
||||||
|
2016
|
|
2015
|
||||
Accrued executive deferred compensation
|
$
|
8,352
|
|
|
$
|
6,458
|
|
Deferred rent (non-current portion)
|
167
|
|
|
248
|
|
||
Clinical study holdback costs, non-current
|
47
|
|
|
—
|
|
||
Other tax liabilities
|
738
|
|
|
738
|
|
||
Royalty liability
|
300
|
|
|
—
|
|
||
Other long-term liabilities
|
$
|
9,604
|
|
|
$
|
7,444
|
|
|
2016
|
|
2015
|
|
2014
|
||||||
Gross product sales
|
$
|
244,770
|
|
|
$
|
215,136
|
|
|
$
|
284,685
|
|
Commercial rebates and government chargebacks
|
(98,317
|
)
|
|
(61,283
|
)
|
|
(76,636
|
)
|
|||
Data and distribution fees, GPO fees, and inventory management fees
|
(14,979
|
)
|
|
(15,613
|
)
|
|
(21,330
|
)
|
|||
Prompt pay discounts
|
(755
|
)
|
|
(16
|
)
|
|
(260
|
)
|
|||
Product returns allowances
|
(2,123
|
)
|
|
(1,373
|
)
|
|
78
|
|
|||
Net product sales
|
$
|
128,596
|
|
|
$
|
136,851
|
|
|
$
|
186,537
|
|
|
Year Ended December 31,
|
|||||||||||||||||||
|
2016
|
|
2015
|
|
2014
|
|||||||||||||||
AmerisourceBergen Corporation, and its affiliates
|
$
|
93,951
|
|
|
38.4
|
%
|
|
$
|
78,989
|
|
|
36.7
|
%
|
|
$
|
115,079
|
|
|
40.4
|
%
|
McKesson Corporation and its affiliates
|
75,952
|
|
|
31.0
|
%
|
|
73,577
|
|
|
34.2
|
%
|
|
93,656
|
|
|
32.9
|
%
|
|||
Cardinal Health, Inc. and its affiliates
|
58,780
|
|
|
24.0
|
%
|
|
37,414
|
|
|
17.4
|
%
|
|
*
|
|
|
—
|
%
|
|||
All other customers
|
16,087
|
|
|
6.6
|
%
|
|
25,156
|
|
|
11.7
|
%
|
|
75,950
|
|
|
26.7
|
%
|
|||
Gross product sales
|
$
|
244,770
|
|
|
100.0
|
%
|
|
$
|
215,136
|
|
|
100.0
|
%
|
|
$
|
284,685
|
|
|
100.0
|
%
|
*
|
Less than
10%
|
|
Year Ended December 31,
|
|||||||||||||||||||
|
2016
|
|
2015
|
|
2014
|
|||||||||||||||
United States
|
$
|
125,074
|
|
|
97.3
|
%
|
|
$
|
130,432
|
|
|
95.3
|
%
|
|
$
|
177,979
|
|
|
95.4
|
%
|
International:
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||
Europe
|
3,522
|
|
|
2.7
|
%
|
|
2,234
|
|
|
1.6
|
%
|
|
3,357
|
|
|
1.8
|
%
|
|||
Asia Pacific*
|
—
|
|
|
—
|
%
|
|
4,185
|
|
|
3.1
|
%
|
|
5,201
|
|
|
2.8
|
%
|
|||
Total International
|
3,522
|
|
|
2.7
|
%
|
|
6,419
|
|
|
4.7
|
%
|
|
8,558
|
|
|
4.6
|
%
|
|||
Net product sales
|
$
|
128,596
|
|
|
100
|
%
|
|
$
|
136,851
|
|
|
100.0
|
%
|
|
$
|
186,537
|
|
|
100.0
|
%
|
|
Year Ended December 31,
|
|||||||||||||||||||
|
2016
|
|
2015
|
|
2014
|
|||||||||||||||
FUSILEV
|
$
|
34,839
|
|
|
27.1
|
%
|
|
$
|
60,710
|
|
|
44.4
|
%
|
|
$
|
105,608
|
|
|
56.6
|
%
|
FOLOTYN
|
46,245
|
|
|
36.0
|
%
|
|
40,606
|
|
|
29.7
|
%
|
|
47,556
|
|
|
25.5
|
%
|
|||
ZEVALIN
|
10,730
|
|
|
8.3
|
%
|
|
17,457
|
|
|
12.8
|
%
|
|
22,169
|
|
|
11.9
|
%
|
|||
MARQIBO
|
7,245
|
|
|
5.6
|
%
|
|
8,006
|
|
|
5.9
|
%
|
|
6,328
|
|
|
3.4
|
%
|
|||
BELEODAQ
|
13,368
|
|
|
10.4
|
%
|
|
10,072
|
|
|
7.4
|
%
|
|
4,876
|
|
|
2.6
|
%
|
|||
EVOMELA
|
16,169
|
|
|
12.6
|
%
|
|
—
|
|
|
—
|
%
|
|
—
|
|
|
—
|
%
|
|||
Net product sales
|
$
|
128,596
|
|
|
100.0
|
%
|
|
$
|
136,851
|
|
|
100.0
|
%
|
|
$
|
186,537
|
|
|
100.0
|
%
|
|
Year Ended December 31,
|
|||||||||||||||||||
|
2016
|
|
2015
|
|
2014
|
|||||||||||||||
Out-license of ZEVALIN, FOLOTYN, BELEODAQ, MARQIBO: upfront receipt for the Canada territory (
Note 17(b)(xiv)
)
|
$
|
6,000
|
|
|
33.6
|
%
|
|
$
|
—
|
|
|
—
|
%
|
|
$
|
—
|
|
|
—
|
%
|
Sales and marketing contracted services (
Note 14
)
|
9,096
|
|
|
51.0
|
%
|
|
—
|
|
|
—
|
%
|
|
—
|
|
|
—
|
%
|
|||
Out-license of ZEVALIN: upfront receipts and royalties for Asia and certain other territories, excluding China (
Note 12
)
|
1,756
|
|
|
9.8
|
%
|
|
15,144
|
|
|
58.9
|
%
|
|
—
|
|
|
—
|
%
|
|||
Out-license of FOLOTYN in all countries except the U.S., Canada, Europe, and Turkey (
Note 16
)
|
927
|
|
|
5.2
|
%
|
|
831
|
|
|
3.2
|
%
|
|
293
|
|
|
100.0
|
%
|
|||
Out-license of ZEVALIN, MARQIBO, EVOMELA: upfront receipt for the China territory (
Note 11
)
|
—
|
|
|
—
|
%
|
|
9,682
|
|
|
37.7
|
%
|
|
—
|
|
|
—
|
%
|
|||
Out-license of ZEVALIN: amortization of upfront receipt related to India territory (
Note17(b)(iii)
) and other
|
69
|
|
|
0.4
|
%
|
|
48
|
|
|
0.2
|
%
|
|
—
|
|
|
—
|
%
|
|||
License fees and service revenues
|
$
|
17,848
|
|
|
100.0
|
%
|
|
$
|
25,705
|
|
|
100.0
|
%
|
|
$
|
293
|
|
|
100.0
|
%
|
|
Year Ended December 31,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
Cost of product sales
|
$
|
135
|
|
|
$
|
62
|
|
|
$
|
—
|
|
Selling, general and administrative
|
10,410
|
|
|
10,049
|
|
|
10,053
|
|
|||
Research and development
|
1,867
|
|
|
1,973
|
|
|
1,756
|
|
|||
Total
|
$
|
12,412
|
|
|
$
|
12,084
|
|
|
$
|
11,809
|
|
|
Year Ended December 31,
|
||||
|
2016
|
|
2015
|
|
2014
|
Expected option life (in years) (a)
|
5.02
|
|
5.43
|
|
4.95
|
Risk-free interest rate (b)
|
1.07% - 1.90%
|
|
1.25% - 1.68%
|
|
0.58% - 1.52%
|
Volatility (c)
|
48.9% - 50.6%
|
|
48.0% - 50.2%
|
|
48.9% - 62.1%
|
Dividend yield (d)
|
—%
|
|
—%
|
|
—%
|
Weighted-average grant-date fair value per stock option
|
$2.80
|
|
$2.85
|
|
$3.49
|
(a)
|
Determined by the historical stock option exercise behavior of our employees (maximum term is
10
years).
|
(b)
|
Based upon the U.S. Treasury yields in effect during the period which the options were granted (for a period equaling the stock options’ expected term).
|
(c)
|
Measured using our historical stock price for a period equal to stock options’ expected term.
|
(d)
|
We do not expect to declare any cash dividends in the foreseeable future
.
|
|
Number of
Shares |
|
Weighted-
Average Exercise Price/Share |
|
Weighted-
Average Remaining Contractual Term (Years) |
|
Aggregate
Intrinsic Value |
|
|
||||||
Outstanding — December 31, 2013
|
11,329,218
|
|
|
$
|
7.10
|
|
|
|
|
|
|
|
|||
Granted
|
2,576,292
|
|
|
7.60
|
|
|
|
|
|
|
|
||||
Exercised
|
(485,260
|
)
|
|
4.77
|
|
|
|
|
$
|
1,629
|
|
|
(1
|
)
|
|
Forfeited
|
(557,109
|
)
|
|
9.65
|
|
|
|
|
|
|
|
||||
Expired
|
(214,039
|
)
|
|
10.70
|
|
|
|
|
|
|
|
||||
Outstanding — December 31, 2014
|
12,649,102
|
|
|
7.12
|
|
|
|
|
|
|
|
||||
Granted
|
2,219,587
|
|
|
6.04
|
|
|
|
|
|
|
|
||||
Exercised
|
(456,082
|
)
|
|
4.45
|
|
|
|
|
$
|
977
|
|
|
(1
|
)
|
|
Forfeited
|
(296,162
|
)
|
|
8.06
|
|
|
|
|
|
|
|
||||
Expired
|
(279,594
|
)
|
|
9.05
|
|
|
|
|
|
|
|
||||
Outstanding — December 31, 2015
|
13,836,851
|
|
|
6.97
|
|
|
|
|
|
|
|
|
|||
Granted
|
1,435,550
|
|
|
5.94
|
|
|
|
|
|
|
|
||||
Exercised
|
(39,010
|
)
|
|
5.18
|
|
|
|
|
$
|
50
|
|
|
(1
|
)
|
|
Forfeited
|
(379,268
|
)
|
|
7.21
|
|
|
|
|
|
|
|
||||
Expired
|
(513,541
|
)
|
|
7.26
|
|
|
|
|
|
|
|
||||
Outstanding — December 31, 2016
|
14,340,582
|
|
|
$
|
6.86
|
|
|
5.71
|
|
$
|
2,848
|
|
|
(2
|
)
|
Vested (exercisable) — December 31, 2016
|
11,206,200
|
|
|
$
|
6.99
|
|
|
4.87
|
|
$
|
2,829
|
|
|
(2
|
)
|
Unvested (unexercisable) — December 31, 2016
|
3,134,382
|
|
|
$
|
6.37
|
|
|
8.70
|
|
$
|
19
|
|
|
(2
|
)
|
(1)
|
Represents the total
difference
between our closing stock price at the time of exercise and the stock option exercise price, multiplied by the number of options exercised.
|
(2)
|
Represents the total
difference
between our closing stock price on the last trading day of
2016
and the stock option exercise price,
multiplied by
the number of in-the-money options as of
December 31, 2016
. The amount of intrinsic value will change based on the fair market value of our stock.
|
|
Outstanding
|
|
Exercisable
|
||||||||||||
Exercise Price
|
Granted Stock
Options Outstanding |
|
Weighted-
Average Remaining Contractual Life (Years) |
|
Weighted-
Average Exercise Price |
|
Granted
Stock Options Exercisable |
|
Weighted-
Average Exercise Price |
||||||
$0.92 - 3.15
|
1,090,385
|
|
|
1.49
|
|
$
|
2.18
|
|
|
1,090,385
|
|
|
$
|
2.18
|
|
$3.16 - 4.95
|
1,422,320
|
|
|
3.60
|
|
4.24
|
|
|
1,349,320
|
|
|
4.24
|
|
||
$4.96 - 6.9
|
5,413,364
|
|
|
6.22
|
|
6.09
|
|
|
3,323,866
|
|
|
6.21
|
|
||
$6.91 - 8.99
|
4,000,514
|
|
|
6.62
|
|
7.78
|
|
|
3,038,641
|
|
|
7.87
|
|
||
$9.00 - 16.32
|
2,413,999
|
|
|
6.21
|
|
10.68
|
|
|
2,403,988
|
|
|
10.69
|
|
||
|
14,340,582
|
|
|
5.71
|
|
$
|
6.86
|
|
|
11,206,200
|
|
|
$
|
6.99
|
|
|
Number of
Restricted Stock Awards |
|
Weighted Average
Fair Value per Share at Grant Date |
|||
Unvested — December 31, 2013
|
1,007,119
|
|
|
$
|
10.09
|
|
Granted
|
581,194
|
|
|
7.52
|
|
|
Vested
|
(578,985
|
)
|
|
10.24
|
|
|
Forfeited
|
(185,111
|
)
|
|
9.88
|
|
|
Unvested — December 31, 2014
|
824,217
|
|
|
8.22
|
|
|
Granted
|
1,948,585
|
|
|
6.32
|
|
|
Vested
|
(364,507
|
)
|
|
8.47
|
|
|
Forfeited
|
(234,313
|
)
|
|
7.32
|
|
|
Unvested — December 31, 2015
|
2,173,982
|
|
|
6.58
|
|
|
Granted
|
1,203,675
|
|
|
5.93
|
|
|
Vested
|
(889,857
|
)
|
|
6.49
|
|
|
Forfeited
|
(335,643
|
)
|
|
6.33
|
|
|
Unvested — December 31, 2016
|
2,152,157
|
|
|
$
|
6.29
|
|
|
2016
|
|
2015
|
|
2014
|
||||||
Restricted stock expense
|
$
|
6,005
|
|
|
$
|
4,006
|
|
|
$
|
3,830
|
|
|
2016
|
|
2015
|
|
2014
|
||||||
Shares of common stock issued
|
172,650
|
|
|
179,865
|
|
|
133,734
|
|
|||
Match contribution value*
|
$
|
953
|
|
|
$
|
1,124
|
|
|
$
|
1,028
|
|
*
|
Represents our stock price on the date of the common stock issuance
multiplied
by the number of shares of common stock issued. The current year value is lower compared to the prior year periods due to the November and December 2016 401(k) match being made with cash instead of shares of common stock.
|
2018 Convertible Notes
|
10,454,799
|
|
Exercise of issued employee stock options
|
14,340,582
|
|
Exercise of issued warrants
|
445,000
|
|
Management incentive plan restricted stock units
|
—
|
|
Total common shares issuable
|
25,240,381
|
|
|
Number of
Shares |
|
Weighted
Average Exercise Price |
|||
Outstanding — December 31, 2013
|
445,000
|
|
|
$
|
6.39
|
|
Granted
|
—
|
|
|
—
|
|
|
Outstanding — December 31, 2014
|
445,000
|
|
|
$
|
6.39
|
|
Granted
|
—
|
|
|
—
|
|
|
Outstanding — December 31, 2015
|
445,000
|
|
|
$
|
6.78
|
|
Granted
|
—
|
|
|
—
|
|
|
Outstanding — December 31, 2016
|
445,000
|
|
|
$
|
6.78
|
|
Exercisable — December 31, 2016
|
445,000
|
|
|
$
|
6.78
|
|
|
|
No. of Common Shares Issued
|
|
Proceeds Received (Net of Broker Commissions and Fees )
|
|||
Common shares issued pursuant to the December 2015 ATM Agreement during the year ended December 31, 2016
|
|
10,890,915
|
|
|
$
|
73,869
|
|
|
Year Ended December 31,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
Net loss
|
$
|
(68,512
|
)
|
|
$
|
(50,785
|
)
|
|
$
|
(45,719
|
)
|
Weighted average shares—basic
|
72,824,070
|
|
|
64,882,417
|
|
|
64,708,163
|
|
|||
Net loss per share—basic
|
$
|
(0.94
|
)
|
|
$
|
(0.78
|
)
|
|
$
|
(0.71
|
)
|
Weighted average shares—diluted
|
72,824,070
|
|
|
64,882,417
|
|
|
64,708,163
|
|
|||
Net loss per share—diluted
|
$
|
(0.94
|
)
|
|
$
|
(0.78
|
)
|
|
$
|
(0.71
|
)
|
|
Year Ended December 31,
|
|||||||
|
2016
|
|
2015
|
|
2014
|
|||
2018 Convertible Notes
|
10,454,799
|
|
|
11,401,284
|
|
|
11,401,284
|
|
Common stock options
|
1,294,594
|
|
|
1,441,086
|
|
|
2,173,916
|
|
Restricted stock awards
|
2,147,157
|
|
|
2,173,615
|
|
|
824,217
|
|
Common stock warrants
|
—
|
|
|
9,357
|
|
|
120,702
|
|
Preferred stock
|
—
|
|
|
40,000
|
|
|
40,000
|
|
Total
|
13,896,550
|
|
|
15,065,342
|
|
|
14,560,119
|
|
|
December 31, 2016
Fair Value Measurements |
|
||||||||||||||
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
|
||||||||
Assets:
|
|
|
|
|
|
|
|
|
||||||||
Bank certificates of deposits
|
$
|
—
|
|
|
$
|
5,991
|
|
|
$
|
—
|
|
|
$
|
5,991
|
|
|
Money market funds
|
—
|
|
|
128,563
|
|
|
—
|
|
|
128,563
|
|
|
||||
Equity securities (
Note 11
)
|
11,533
|
|
|
—
|
|
|
—
|
|
|
11,533
|
|
|
||||
Mutual funds
|
—
|
|
|
56
|
|
|
—
|
|
|
56
|
|
|
||||
Deferred compensation investments (life insurance cash surrender value)
|
—
|
|
|
11,863
|
|
|
—
|
|
|
11,863
|
|
*
|
||||
|
$
|
11,533
|
|
|
$
|
146,473
|
|
|
$
|
—
|
|
|
$
|
158,006
|
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
||||||||
Deferred executive compensation liability (
Note 17(f)
)
|
—
|
|
|
8,352
|
|
|
—
|
|
|
8,352
|
|
*
|
||||
Drug development liability (
Note 16
)
|
—
|
|
|
—
|
|
|
13,130
|
|
|
13,130
|
|
|
||||
Ligand Contingent Consideration (
Note 10 (b)
)
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
||||
Talon CVR (
Note 10 (a)
)
|
—
|
|
|
—
|
|
|
1,253
|
|
|
1,253
|
|
|
||||
Corixa Liability
|
—
|
|
|
—
|
|
|
62
|
|
|
62
|
|
|
||||
|
$
|
—
|
|
|
$
|
8,352
|
|
|
$
|
14,445
|
|
|
$
|
22,797
|
|
|
|
December 31, 2015
Fair Value Measurements |
|
||||||||||||||
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
|
||||||||
Assets:
|
|
|
|
|
|
|
|
|
||||||||
Bank certificates of deposits
|
$
|
—
|
|
|
$
|
245
|
|
|
$
|
—
|
|
|
$
|
245
|
|
|
Money market funds
|
—
|
|
|
80,116
|
|
|
—
|
|
|
80,116
|
|
|
||||
Equity securities
|
5,189
|
|
|
—
|
|
|
—
|
|
|
5,189
|
|
|
||||
Deferred compensation investments (life insurance cash surrender value)
|
—
|
|
|
9,181
|
|
|
—
|
|
|
9,181
|
|
*
|
||||
|
$
|
5,189
|
|
|
$
|
89,542
|
|
|
$
|
—
|
|
|
$
|
94,731
|
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
||||||||
Deferred executive compensation liability
|
—
|
|
|
6,458
|
|
|
—
|
|
|
6,458
|
|
*
|
||||
Drug development liability
|
—
|
|
|
—
|
|
|
14,686
|
|
|
14,686
|
|
|
||||
Ligand Contingent Consideration
|
—
|
|
|
—
|
|
|
5,227
|
|
|
5,227
|
|
|
||||
Talon CVR
|
—
|
|
|
—
|
|
|
1,377
|
|
|
1,377
|
|
|
||||
Corixa Liability
|
—
|
|
|
—
|
|
|
62
|
|
|
62
|
|
|
||||
|
$
|
—
|
|
|
$
|
6,458
|
|
|
$
|
21,352
|
|
|
$
|
27,810
|
|
|
|
Fair Value Measurements of
Unobservable Inputs ( Level 3 ) |
|
||
Balance at December 31, 2014
|
$
|
23,127
|
|
|
Deferred drug development costs
|
(1,099
|
)
|
|
|
Ligand Contingent Consideration fair value adjustment
|
326
|
|
|
|
Talon CVR fair value adjustment
|
(1,002
|
)
|
|
|
Balance at December 31, 2015
|
$
|
21,352
|
|
|
Settlement of Ligand Contingent Consideration liability (
Note 10(b)
)
|
(6,000
|
)
|
|
|
Deferred drug development costs (
Note 16
)
|
(1,556
|
)
|
|
|
Ligand Contingent Consideration fair value adjustment prior to settlement (
Note 10(b)
)
|
773
|
|
|
|
Talon CVR fair value adjustment (
Note 10(a)
)
|
(124
|
)
|
|
|
Balance at December 31, 2016
|
$
|
14,445
|
|
*
|
•
|
$5.0 million
upon the achievement of net sales of MARQIBO in excess of
$30.0 million
in any calendar year
|
•
|
$10.0 million
upon the achievement of net sales of MARQIBO in excess of
$60.0 million
in any calendar year
|
•
|
$25.0 million
upon the achievement of net sales of MARQIBO in excess of
$100.0 million
in any calendar year
|
•
|
$50.0 million
upon the achievement of net sales of MARQIBO in excess of
$200.0 million
in any calendar year
|
•
|
$100.0 million
upon the achievement of net sales of MARQIBO in excess of
$400.0 million
in any calendar year
|
•
|
$5.0 million
upon receipt of marketing authorization from the FDA regarding Menadione Topical Lotion
|
|
Fair Value
of Talon CVR |
||
December 31, 2015
|
$
|
1,377
|
|
Fair value adjustment for the year ended December 31, 2016
|
(124
|
)
|
|
December 31, 2016
|
$
|
1,253
|
|
Cash consideration
|
$
|
3,000
|
|
Ligand Contingent Consideration
|
4,700
|
|
|
Total purchase consideration
|
$
|
7,700
|
|
IPR&D EVOMELA rights
|
$
|
7,700
|
|
|
Fair Value of
Ligand Contingent Consideration |
||
December 31, 2015
|
$
|
5,227
|
|
Fair value adjustment for the three months ended March 31, 2016
|
773
|
|
|
Payment to Ligand in April 2016 for FDA approval milestone achievement
|
(6,000
|
)
|
|
December 31, 2016
|
$
|
—
|
|
CASI common stock (5.4 million shares)
|
$
|
8,649
|
|
(a)
|
CASI secured promissory note due March 17, 2018, net of fair value discount ($1.5 million face value and 0.5% annual coupon)
|
1,310
|
|
(b)
|
|
Total consideration received, net of fair value discount
|
$
|
9,959
|
|
(c)
|
(a)
|
Value determined based on the September 17, 2014 closing price of
5.4 million
shares of CASI common stock on the NASDAQ Capital Market of
$1.60
per share. Our current intention is to hold these securities on a long-term basis. Accordingly, we have presented its value of
$11.5 million
as of
December 31, 2016
within “other assets” (rather than “marketable securities”) on our accompanying Consolidated Balance Sheets. The change in fair value of these securities is reported within “unrealized gain (loss) on available-for-sale securities” on the accompanying Consolidated Statement of Comprehensive Loss.
|
(b)
|
Value estimated using the terms of the
$1.5 million
promissory note, the application of a synthetic debt rating based on CASI’s publicly-available financial information, and the prevailing interest yields on similar public debt securities as of September 17, 2014. The full balance of the promissory note was prospectively reclassified beginning
December 31, 2016
to "other assets" (presented within non-current assets on the accompanying Consolidated Balance Sheets) from "other receivables" (presented within current assets) due to this note's maturity being extended to March 17, 2018.
|
(c)
|
Presented within “license fees and service revenue” in the accompanying Consolidated Statement of Operations for the year ended December 31, 2015 (see below).
|
|
Year Ended December 31,
|
||||||
|
2016
|
|
2015
|
||||
Principal amount
|
$
|
110,037
|
|
|
$
|
120,000
|
|
(Less): Unamortized debt discount (amortized through December 2018)
|
(11,646
|
)
|
|
(18,452
|
)
|
||
(Less): Debt issuance costs (see
Note 3(e)
)
|
(1,348
|
)
|
|
(2,171
|
)
|
||
Carrying value
|
$
|
97,043
|
|
|
$
|
99,377
|
|
|
Year Ended December 31,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
Contractual coupon interest expense
|
$
|
3,288
|
|
|
$
|
3,300
|
|
|
$
|
3,300
|
|
Amortization of debt issuance costs
|
696
|
|
|
662
|
|
|
599
|
|
|||
Accretion of debt discount
|
5,710
|
|
|
5,250
|
|
|
4,818
|
|
|||
Total
|
$
|
9,694
|
|
|
$
|
9,212
|
|
|
$
|
8,717
|
|
Effective interest rate
|
8.65
|
%
|
|
8.66
|
%
|
|
8.66
|
%
|
|
Drug
Development Liability, Current – FOLOTYN |
|
Drug
Development Liability, Long Term – FOLOTYN |
|
Total Drug
Development Liability – FOLOTYN |
||||||
Balance at December 31, 2015
|
$
|
259
|
|
|
$
|
14,427
|
|
|
$
|
14,686
|
|
Transfer from long-term to current in 2016
|
2,158
|
|
|
(2,158
|
)
|
|
—
|
|
|||
(Less): Expenses incurred in 2016
|
(1,556
|
)
|
|
—
|
|
|
(1,556
|
)
|
|||
Balance at December 31, 2016
|
$
|
861
|
|
|
$
|
12,269
|
|
|
$
|
13,130
|
|
Year ending December 31,
|
Operating Lease
Minimum Payments |
||
2017
|
$
|
1,172
|
|
2018
|
1,209
|
|
|
2019
|
460
|
|
|
2020
|
—
|
|
|
2021
|
—
|
|
|
|
$
|
2,841
|
|
|
For the Years Ended
December 31, |
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
Current:
|
|
|
|
|
|
||||||
Federal
|
$
|
(2,001
|
)
|
|
$
|
113
|
|
|
$
|
1,529
|
|
State
|
(216
|
)
|
|
5
|
|
|
126
|
|
|||
Foreign
|
8
|
|
|
148
|
|
|
29
|
|
|||
|
$
|
(2,209
|
)
|
|
$
|
266
|
|
|
$
|
1,684
|
|
Deferred:
|
|
|
|
|
|
||||||
Federal
|
(93
|
)
|
|
114
|
|
|
495
|
|
|||
State
|
(11
|
)
|
|
26
|
|
|
7
|
|
|||
Foreign
|
—
|
|
|
—
|
|
|
—
|
|
|||
|
(104
|
)
|
|
140
|
|
|
502
|
|
|||
Total income tax (benefit) provision
|
$
|
(2,313
|
)
|
|
$
|
406
|
|
|
$
|
2,186
|
|
|
2016
|
|
2015
|
|
2014
|
||||||
Tax provision computed at the federal statutory rate
|
$
|
(24,777
|
)
|
|
$
|
(17,619
|
)
|
|
$
|
(15,236
|
)
|
State tax, net of federal benefit
|
(261
|
)
|
|
232
|
|
|
66
|
|
|||
Research credits
|
(3,232
|
)
|
|
(2,974
|
)
|
|
(2,134
|
)
|
|||
Change in tax credit carryforwards
|
11,042
|
|
|
(4,965
|
)
|
|
—
|
|
|||
Transaction costs
|
—
|
|
|
—
|
|
|
(11
|
)
|
|||
Officers compensation
|
1,159
|
|
|
1,577
|
|
|
1,895
|
|
|||
Stock based compensation
|
556
|
|
|
535
|
|
|
299
|
|
|||
Permanent items and other
|
12
|
|
|
(487
|
)
|
|
21,742
|
|
|||
Domestic manufacturing deduction
|
—
|
|
|
—
|
|
|
(630
|
)
|
|||
Tax differential on foreign earnings
|
15
|
|
|
1,435
|
|
|
1,570
|
|
|||
Change in tax rate
|
(744
|
)
|
|
(903
|
)
|
|
(519
|
)
|
|||
Valuation allowance
|
13,917
|
|
|
23,575
|
|
|
(4,856
|
)
|
|||
Income tax (benefit) provision
|
$
|
(2,313
|
)
|
|
$
|
406
|
|
|
$
|
2,186
|
|
|
2016
|
|
2015
|
|
2014
|
||||||
Deferred tax assets:
|
|
|
|
|
|
||||||
Net operating loss carry forwards
|
$
|
57,404
|
|
|
$
|
41,251
|
|
|
$
|
40,505
|
|
Research credits
|
11,480
|
|
|
22,082
|
|
|
9,045
|
|
|||
Stock based compensation
|
5,546
|
|
|
4,828
|
|
|
3,703
|
|
|||
Deferred revenue
|
1,380
|
|
|
2,280
|
|
|
1,893
|
|
|||
Development costs
|
7,180
|
|
|
5,504
|
|
|
5,950
|
|
|||
Returns and allowances
|
2,178
|
|
|
1,363
|
|
|
4,161
|
|
|||
Other, net
|
10,530
|
|
|
9,887
|
|
|
9,082
|
|
|||
Total deferred tax assets before valuation allowance
|
95,698
|
|
|
87,195
|
|
|
74,339
|
|
|||
Valuation allowance
|
(84,822
|
)
|
|
(71,815
|
)
|
|
(45,983
|
)
|
|||
Total deferred tax assets
|
10,876
|
|
|
15,380
|
|
|
28,356
|
|
|||
Deferred tax liabilities:
|
|
|
|
|
|
||||||
Basis difference in debt
|
(447
|
)
|
|
(713
|
)
|
|
(907
|
)
|
|||
Depreciation and amortization differences
|
(17,104
|
)
|
|
(21,446
|
)
|
|
(34,088
|
)
|
|||
Net deferred tax liabilities
|
$
|
(6,675
|
)
|
|
$
|
(6,779
|
)
|
|
$
|
(6,639
|
)
|
|
2016
|
|
2015
|
|
2014
|
||||||
Balance at beginning of year
|
$
|
4,498
|
|
|
$
|
1,944
|
|
|
$
|
2,212
|
|
Adjustments related to prior year tax positions
|
(1,638
|
)
|
|
1,318
|
|
|
(915
|
)
|
|||
Increases related to current year tax positions
|
411
|
|
|
1,236
|
|
|
647
|
|
|||
Decreases due to settlements
|
—
|
|
|
—
|
|
|
—
|
|
|||
Decreases related to prior year tax positions
|
—
|
|
|
—
|
|
|
—
|
|
|||
Balance at end of year
|
$
|
3,271
|
|
|
$
|
4,498
|
|
|
$
|
1,944
|
|
|
Quarter Ended (Unaudited)
|
||||||||||||||
|
March 31
|
|
June 30
|
|
September 30
|
|
December 31
|
||||||||
2016
|
|
|
|
|
|
|
|
||||||||
Total revenues
|
$
|
43,866
|
|
|
$
|
33,949
|
|
|
$
|
33,393
|
|
|
$
|
35,236
|
|
Operating loss
|
$
|
(6,283
|
)
|
|
$
|
(22,081
|
)
|
|
$
|
(15,996
|
)
|
|
$
|
(17,269
|
)
|
Net loss
|
$
|
(9,321
|
)
|
|
$
|
(24,295
|
)
|
|
$
|
(17,455
|
)
|
|
$
|
(17,442
|
)
|
Net loss per share, basic and diluted
|
$
|
(0.14
|
)
|
|
$
|
(0.35
|
)
|
|
$
|
(0.22
|
)
|
|
$
|
(0.22
|
)
|
2015
|
|
|
|
|
|
|
|
||||||||
Total revenues
|
$
|
38,618
|
|
|
$
|
44,982
|
|
|
$
|
28,627
|
|
|
$
|
50,329
|
|
Operating loss
|
$
|
(21,661
|
)
|
|
$
|
(34
|
)
|
|
$
|
(16,074
|
)
|
|
$
|
(2,963
|
)
|
Net loss
|
$
|
(25,562
|
)
|
|
$
|
(2,346
|
)
|
|
$
|
(18,724
|
)
|
|
$
|
(4,153
|
)
|
Net loss per share, basic and diluted
|
$
|
(0.39
|
)
|
|
$
|
(0.04
|
)
|
|
$
|
(0.28
|
)
|
|
$
|
(0.07
|
)
|
(a)
|
Financial Statements and Schedules
|
|
|
|
Additions
(Reductions) |
|
|
|
|
||||||||||||
Description
|
Balance at
Beginning of Period |
|
Additions
(Recovery) to Bad Debt Expense |
|
Charged
to Other Accounts |
|
Deductions (1)
|
|
Balance at
End of Period |
||||||||||
|
(in thousands)
|
||||||||||||||||||
December 31, 2016
|
|
|
|
|
|
|
|
|
|
||||||||||
Allowance for doubtful accounts
|
$
|
120
|
|
|
$
|
57
|
|
|
$
|
—
|
|
|
$
|
(89
|
)
|
|
$
|
88
|
|
December 31, 2015
|
|
|
|
|
|
|
|
|
|
||||||||||
Allowance for doubtful accounts
|
$
|
120
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
120
|
|
December 31, 2014
|
|
|
|
|
|
|
|
|
|
||||||||||
Allowance for doubtful accounts
|
$
|
206
|
|
|
$
|
(85
|
)
|
|
$
|
—
|
|
|
$
|
(1
|
)
|
|
$
|
120
|
|
(1)
|
Deductions represent the actual write-off of accounts receivable balances.
|
Exhibit No.
|
|
Description
|
|
|
|
2.1
|
|
Asset Purchase Agreement, dated August 15, 2007, by and between Cell Therapeutics, Inc. and Biogen Idec Inc. (Filed as Exhibit 10.1 to Cell Therapeutics, Inc.’s Form 8-K, No. 001-12465, as filed with the Securities and Exchange Commission on August 21, 2007, and incorporated herein by reference.)
|
|
|
|
2.2
|
|
First Amendment to Asset Purchase Agreement, dated December 9, 2008, by and between Cell Therapeutics, Inc. and Biogen Idec Inc. (Filed as Exhibit 10.48 to Cell Therapeutics, Inc.’s Form 10K, No. 001-12465, as filed with the Securities and Exchange Commission on March 16, 2009, and incorporated herein by reference.)
|
|
|
|
2.3#
|
|
License and Asset Purchase Agreement, dated January 23, 2012, by and between Spectrum Pharmaceuticals Cayman, L.P. and Bayer Pharma AG. (Filed as Exhibit 2.1 to Form 10-Q, No. 001-35006, as filed with the Securities and Exchange Commission on April 27, 2012, and incorporated herein by reference.)
|
|
|
|
2.4
|
|
Agreement and Plan of Merger, dated April 4, 2012, by and among Spectrum Pharmaceuticals, Inc., Sapphire Acquisition Sub, Inc. and Allos Therapeutics, Inc., including a Form of Contingent Value Rights Agreement and a Form of Tender and Voting Agreement. (Filed as Exhibits 2.1, 2.2 and 2.3, respectively, to Form 8-K, No. 001-35006, as filed with the Securities and Exchange Commission on April 5, 2012, and incorporated herein by reference.)
|
|
|
|
2.5
|
|
Securities Purchase Agreement, dated July 16, 2013, by and among Spectrum Pharmaceuticals, Inc., Eagle Acquisition Merger Sub, Inc., certain entities affiliated with Warburg Pincus & Co. and certain entities affiliated with Deerfield Management, LLC. (Filed as Exhibit 2.1 to Form 8-K, No. 001-35006, as filed with the Securities and Exchange Commission on July 19, 2013, and incorporated herein by reference.)
|
|
|
|
2.6
|
|
Stock Purchase Agreement, dated July 16, 2013, by and among Spectrum Pharmaceuticals, Inc., Eagle Acquisition Merger Sub, Inc. and Talon Therapeutics, Inc. (Filed as Exhibit 2.2 to Form 8-K, No. 001-35006, as filed with the Securities and Exchange Commission on July 19, 2013, and incorporated herein by reference.)
|
|
|
|
2.7
|
|
Contingent Value Rights Agreement, dated July 16, 2013, by and among Spectrum Pharmaceuticals, Inc., Talon Therapeutics, Inc. and Corporate Stock Transfer Inc. as rights agent. (Filed as Exhibit 2.3 to Form 8-K, No. 001-35006, as filed with the Securities and Exchange Commission on July 19, 2013, and incorporated herein by reference.)
|
|
|
2.8
|
|
Exchange Agreement, dated July 16, 2013, by and among Talon Therapeutics, Inc. and certain entities affiliated with Deerfield Management, LLC, including the Registration Rights Agreement by and among Spectrum Pharmaceuticals, Inc. and certain entities affiliated with Deerfield Management, LLC, as Exhibit A thereto. (Filed as Exhibit 2.4 to Form 8-K, No. 001-35006, as filed with the Securities and Exchange Commission on July 19, 2013, and incorporated herein by reference.)
|
|
|
|
3.1
|
|
Certificate of Incorporation, as amended through June 24, 2011. (Filed as Exhibit 3.1 to Form 10-K, No. 001-35006, as filed with the Securities and Exchange Commission on March 2, 2012, and incorporated herein by reference.)
|
|
|
|
3.2
|
|
Second Amended and Restated Bylaws of Spectrum Pharmaceuticals, Inc. (Filed as Exhibit 3.2 to Form 8-K, No. 001-35006, as filed with the Securities and Exchange Commission on August 8, 2012, and incorporated herein by reference.)
|
|
|
|
4.1
|
|
Rights Agreement, dated December 13, 2010, between Spectrum Pharmaceuticals, Inc. and ComputerShare Trust Company, N.A. (formerly U.S. Stock Transfer Corporation), as Rights Agent, which includes as Exhibit A thereto the form of Certificate of Designation for the Series B Junior Participating Preferred Stock, as Exhibit B thereto the Form of Rights Certificate and as Exhibit C thereto a Summary of Rights of Stockholder Rights Plan. (Filed as Exhibit 4.1 to Form 8-K, No. 000-28782, as filed with the Securities and Exchange Commission on December 13, 2010, and incorporated herein by reference.)
|
|
|
|
4.2
|
|
Registration Rights and Stockholder Agreement, dated February 2, 2010, by and between Spectrum Pharmaceuticals, Inc. and Topotarget A/S. (Filed as Exhibit 4.2 to Form 10-K, No. 001-35006, as filed with the Securities and Exchange Commission on March 12, 2014, and incorporated herein by reference.)
|
|
|
|
4.3
|
|
Indenture, dated December 23, 2013, by and between Spectrum Pharmaceuticals, Inc. and Wilmington Trust, National Association. (Filed as Exhibit 4.1 to Form 8-K, No. 001-35006, as filed with the Securities and Exchange Commission on December 23, 2013, and incorporated herein by reference.)
|
|
|
|
4.4
|
|
Form of Note for Spectrum Pharmaceuticals, Inc.’s 2.75% Convertible Senior Notes due 2018. (Filed as Exhibit 4.2 to Form 8-K, No. 001-35006, as filed with the Securities and Exchange Commission on December 23, 2013, and incorporated herein by reference.)
|
|
|
|
10.1
|
|
Sublease Agreement, dated December 2, 2010, between Spectrum Pharmaceuticals, Inc. and Del Webb Corporation. (Filed as Exhibit 10.1 to Form 10-K, No. 001-35006, as filed with the Securities and Exchange Commission on March 10, 2011, and incorporated herein by reference.)
|
|
|
|
10.2
|
|
First Amendment to Sublease Agreement, dated November 16, 2011, between Spectrum Pharmaceuticals, Inc. and Del Webb Corporation. (Filed as Exhibit 10.2 to Form 10-K, No. 001-35006, as filed with the Securities and Exchange Commission on March 2, 2012, and incorporated herein by reference.)
|
|
|
|
10.3
|
|
Second Amendment to Sublease Agreement, dated November 12, 2012, between Spectrum Pharmaceuticals, Inc. and Del Webb Corporation. (Filed as Exhibit 10.10 to Form 10-K, No. 001-35006, as filed with the Securities and Exchange Commission on February 28, 2013, and incorporated herein by reference.)
|
|
|
|
10.4
|
|
Industrial Lease Agreement, dated January 16, 1997, between Spectrum Pharmaceuticals, Inc. and the Irvine Company. (Filed as Exhibit 10.11 to Form 10-KSB, No. 000-28782, as filed with the Securities and Exchange Commission on March 31, 1997, and incorporated herein by reference.)
|
|
|
|
10.5
|
|
First Amendment, dated March 25, 2004, to Industrial Lease Agreement dated January 16, 1997 by and between Spectrum Pharmaceuticals, Inc. and the Irvine Company. (Filed as Exhibit 10.1 to Form 10-Q, No. 000-28782, as filed with the Securities and Exchange Commission on May 17, 2004, and incorporated herein by reference.)
|
|
|
|
10.6
|
|
Second Amendment, dated March 7, 2006, to Industrial Lease Agreement dated January 16, 1997 by and between Spectrum Pharmaceuticals, Inc. and the Irvine Company. (Filed as Exhibit 10.6 to Form 10-K, No. 001-35006, as filed with the Securities and Exchange Commission on March 12, 2014, and incorporated herein by reference.)
|
|
|
|
10.7
|
|
Third Amendment, dated February 12, 2006, to Industrial Lease Agreement dated January 16, 1997 by and between Spectrum Pharmaceuticals, Inc. and the Irvine Company. (Filed as Exhibit 10.7 to Form 10-K, No. 001-35006, as filed with the Securities and Exchange Commission on March 12, 2014, and incorporated herein by reference.)
|
|
|
|
10.8
|
|
Fourth Amendment, dated July 29, 2009, to Industrial Lease Agreement dated January 16, 1997 by and between Spectrum Pharmaceuticals, Inc. and the Irvine Company. (Filed as Exhibit 10.29 to Form 10-K, No. 000-28782, as filed with the Securities and Exchange Commission on April 5, 2010, and incorporated herein by reference.)
|
|
|
|
10.9
|
|
Fifth Amendment, dated November 21, 2013, to Industrial Lease Agreement dated January 16, 1997 by and between Spectrum Pharmaceuticals, Inc. and the Irvine Company. (Filed as Exhibit 10.9 to Form 10-K, No. 001-35006, as filed with the Securities and Exchange Commission on March 12, 2014, and incorporated herein by reference.)
|
|
|
|
10.10
|
|
Sixth Amendment, dated January 31, 2014, to Industrial Lease Agreement dated January 16, 1997 by and between Spectrum Pharmaceuticals, Inc. and the Irvine Company. (Filed as Exhibit 10.10 to Form 10-K, No. 001-35006, as filed with the Securities and Exchange Commission on March 12, 2014, and incorporated herein by reference.)
|
|
|
|
10.11
|
|
Lease Agreement, dated April 7, 2014, by and between Spectrum Pharmaceuticals, Inc. and 11500 South Eastern Avenue, LLC. (Filed as Exhibit 10.1 to Form 10-Q, No. 001-35006, as filed with the Securities and Exchange Commission on August 8, 2014 and incorporated herein by reference.)
|
|
|
|
10.12
|
|
Preferred Stock and Warrant Purchase Agreement, dated September 26, 2003, by and among Spectrum Pharmaceuticals, Inc. and the purchasers listed on Schedule 1 attached thereto. (Filed as Exhibit 10.1 to Form 8-K, No. 000-28782, as filed with the Securities and Exchange Commission on September 30, 2003, and incorporated herein by reference.)
|
|
|
|
10.13*
|
|
Form of Stock Option Agreement under the 2003 Amended and Restated Incentive Award Plan. (Filed as Exhibit 10.1 to Form 8-K, No. 000-28782, as filed with the Securities and Exchange Commission on December 17, 2004, and incorporated herein by reference.)
|
|
|
|
10.14*
|
|
Form of Non-Employee Director Stock Option Agreement under the 2003 Amended and Restated Incentive Award Plan. (Filed as Exhibit 10.5 to Form 10-Q, No. 000-28782, as filed with the Securities and Exchange Commission on May 10, 2005, and incorporated herein by reference.)
|
|
|
|
10.15*
|
|
2003 Amended and Restated Incentive Award Plan. (Filed as Exhibit 10.1 to Form 8-K, No. 000-28782, as filed with the Securities and Exchange Commission on July 2, 2009, and incorporated herein by reference.)
|
|
|
|
10.16*
|
|
Amendment No. 1 to 2003 Amended and Restated Incentive Award Plan. (Filed as Exhibit 10.1 to Form 10-Q, No. 001-35006, as filed with the Securities and Exchange Commission on November 6, 2015, and incorporated herein by reference.)
|
|
|
|
10.18*
|
|
Deferred Compensation Plan (Filed as Exhibit 4.1 to Form S-8, Reg. No. 333-176681, as filed with the Securities and Exchange Commission on September 6, 2011, and incorporated herein by reference).
|
|
|
|
10.19*
|
|
Executive Employment Agreement entered into June 20, 2008 and effective as of January 2, 2008 by and between Spectrum Pharmaceuticals, Inc. and Dr. Rajesh C. Shotriya. (Filed as Exhibit 10.1 to Form 8-K, No. 000-28782, as filed with the Securities and Exchange Commission on June 26, 2008, and incorporated herein by reference.)
|
|
|
|
10.20*
|
|
First Amendment to Executive Employment Agreement, dated April 17, 2014, by and between Spectrum Pharmaceuticals, Inc. and Dr. Rajesh C. Shrotriya. (Filed as Exhibit 10.2 to Form 10-Q, No. 001-35006, as filed with the Securities and Exchange Commission on August 8, 2014 and incorporated herein by reference).
|
|
|
|
10.21*
|
|
Form of Change in Control Severance Agreement. (Filed as Exhibit 10.1 to Form 8-K, No. 001-35006 as filed with the Securities and Exchange Commission on March 31, 2014, and incorporated herein by reference.)
|
|
|
|
10.22*
|
|
First Amendment to Change in Control Severance Agreement, dated February 18, 2015, by and between Spectrum Pharmaceuticals, Inc. and Joseph W. Turgeon. (Filed as Exhibit 10.22 to Form 10-K, No. 001-35006, as filed with the Securities and Exchange Commission on March 14, 2016 and incorporated herein by reference.)
|
|
|
|
10.23*
|
|
Second Amendment to Change in Control Severance Agreement, dated August 6, 2015, by and between Spectrum Pharmaceuticals, Inc. and Joseph W. Turgeon. (Filed as Exhibit 10.2 to Form 10-Q, No. 001-35006, as filed with the Securities and Exchange Commission on August 7, 2015, and incorporated herein by reference.)
|
|
|
|
10.24*
|
|
Form of Indemnity Agreement of Spectrum Pharmaceuticals, Inc. (Filed as Exhibit 10.32 to Form 10-K, No. 000-28782, as filed with the Securities and Exchange Commission on March 31, 2009, and incorporated herein by reference.)
|
|
|
|
10.25*
|
|
2009 Employee Stock Purchase Plan. (Filed as Exhibit 99.1 to Form S-8, Reg. No. 333-160312, as filed with the Securities and Exchange Commission on June 29, 2009, and incorporated herein by reference.)
|
|
|
|
10.26*
|
|
2009 Incentive Award Plan. (Filed as Exhibit 99.2 to Form S-8, Reg. No. 333-160312, as filed with the Securities and Exchange Commission on June 29, 2009, and incorporated herein by reference.)
|
|
|
10.27*
|
|
Term Sheet for 2009 Incentive Award Plan Stock Option Award. (Filed as Exhibit 10.8 to Form 10-Q, No. 000-28782, as filed with the Securities and Exchange Commission on August 13, 2009, and incorporated herein by reference.)
|
|
|
|
10.28*
|
|
Term Sheet for 2009 Incentive Award Plan, Nonqualified Stock Option Award Awarded to Non-Employee Directors (Revised July 2012). (Filed as Exhibit 10.2 to Form 10-Q, No. 001-35006, as filed with the Securities and Exchange Commission on November 9, 2012, and incorporated herein by reference.)
|
|
|
|
10.29*
|
|
Term Sheet for 2009 Incentive Award Plan, Restricted Stock Award. (Filed as Exhibit 10.10 to Form 10-Q, No. 000-28782, as filed with the Securities and Exchange Commission on August 13, 2009, and incorporated herein by reference.)
|
|
|
|
10.30*
|
|
Amendment No. 1 to 2009 Incentive Award Plan. (Filed as Exhibit 10.2 to Form 10-Q, No. 001-35006, as filed with the Securities and Exchange Commission on November 6, 2015, and incorporated herein by reference.)
|
|
|
|
10.31#
|
|
License and Collaboration Agreement, dated February 2, 2010, by and between Spectrum Pharmaceuticals, Inc. and Topotarget A/S. (Filed as Exhibit 10.37 to Form 10-K, No. 000-28782, as filed with the Securities and Exchange Commission on April 5, 2010, and incorporated herein by reference.)
|
|
|
|
10.32#
|
|
Amendment to License and Collaboration Agreement, dated October 3, 2013, by and between Spectrum Pharmaceuticals, Inc. and Topotarget A/S. (Filed as Exhibit 99.1 to Form 8-K/A, No. 001-35006, as filed with the Securities and Exchange Commission on November 18, 2013, and incorporated herein by reference.)
|
|
|
|
10.33#
|
|
License Agreement for 10-Propargyl-10-Deazaaminopterin “PDX” dated December 23, 2002 and amended May 9, 2006 between Allos Therapeutics, Inc. and SRI International, Sloan-Kettering Institute for Cancer Research and Southern Research Institute. (Filed as Exhibit 10.1 to Allos Therapeutics, Inc.’s Form 10-Q/A, File No. 000-29815, as filed with the Securities and Exchange Commission on August 17, 2012, and incorporated herein by reference.)
|
|
|
|
10.34#
|
|
Second Amendment to License Agreement for 10-Propargyl-10-Deazaaminopterin “PDX” dated November 6, 2007 between Allos Therapeutics, Inc. and SRI International, Sloan-Kettering Institute for Cancer Research and Southern Research Institute. (Filed as Exhibit 10.13.1 to Allos Therapeutics, Inc.’s Form 10-K, No. 000-29815, as filed with the Securities and Exchange Commission on March 1, 2010, and incorporated herein by reference.)
|
|
|
|
10.35#
|
|
Third Amendment to License Agreement for 10-Propargyl-10-Deazaaminopterin “PDX” dated May 10, 2011 between Allos Therapeutics, Inc. and SRI International, Sloan-Kettering Institute for Cancer Research and Southern Research Institute. (Filed as Exhibit 10.3 to Allos Therapeutics, Inc.’s Form 10-Q, No. 000-29815, as filed with the Securities and Exchange Commission on August 4, 2011, and incorporated herein by reference.)
|
|
|
|
10.36#
|
|
Amended and Restated License, Development and Commercialization Agreement, dated May 29, 2013, by and between Allos Therapeutics, Inc. and Mundipharma International Corporation Limited (Filed as Exhibit 10.1 to Form 10-Q, No. 001-35006, as filed with the Securities and Exchange Commission on August 9, 2013, and incorporated herein by reference.)
|
|
|
|
10.37#
|
|
First Amendment to Amended and Restated License, Development and Commercialization Agreement, dated May 29, 2015, by and between Allos Therapeutics, Inc. and Mundipharma International Corporation Limited. (Filed as Exhibit 10.1 to Form 10-Q, No. 001-35006, as filed with the Securities and Exchange Commission on August 7, 2015, and incorporated herein by reference.)
|
|
|
|
10.38#
|
|
Amended and Restated Supply Agreement, dated May 29, 2013, by and between Allos Therapeutics, Inc. and Mundipharma Medical Company (Filed as Exhibit 10.2 to Form 10-Q, No. 001-35006, as filed with the Securities and Exchange Commission on August 9, 2013, and incorporated herein by reference.)
|
|
|
|
10.39
|
|
License Agreement, dated December 21, 2007, by and between Biogen Idec Inc. and Cell Therapeutics, Inc. (Filed as Exhibit 10.8 to Form 10-Q, No. 001-35006, as filed with the Securities and Exchange Commission on November 9, 2012, and incorporated herein by reference.)
|
|
|
|
10.40
|
|
License-Back Agreement, dated December 21, 2007, by and between Biogen Idec Inc. and Cell Therapeutics, Inc. (Filed as Exhibit 10.9 to Form 10-Q, No. 001-35006, as filed with the Securities and Exchange Commission on November 9, 2012, and incorporated herein by reference.)
|
|
|
|
10.41#
|
|
Sublicense Agreement, dated December 21, 2007, by and among Cell Therapeutics, Inc., Biogen Idec Inc., SmithKline Beecham Corporation d/b/a GlaxoSmithKline and Glaxo Group Limited. (Filed as Exhibit 10.11 to Form 10-Q, No. 001-35006, as filed with the Securities and Exchange Commission on November 9, 2012, and incorporated herein by reference.)
|
|
|
10.42#
|
|
Sublicense Agreement, dated December 21, 2007, by and among Cell Therapeutics, Inc., Biogen Idec Inc., Corixa Corporation, Coulter Pharmaceutical, Inc., The Regents of the University of Michigan and SmithKline Beecham Corporation d/b/a GlaxoSmithKline. (Filed as Exhibit 10.12 to Form 10-Q, No. 001-35006, as filed with the Securities and Exchange Commission on November 9, 2012, and incorporated herein by reference.)
|
|
|
|
10.43
|
|
Security Agreement, dated December 15, 2008, by and between RIT Oncology, LLC and Biogen Idec Inc. (Filed as Exhibit 10.35 to Form 10-K, No. 001-35006, as filed with the Securities and Exchange Commission on March 10, 2011, and incorporated herein by reference.)
|
|
|
|
10.44#
|
|
Omnibus Amendment to Zevalin Supply Arrangements, dated October 1, 2012, by and between Biogen Idec US Corporation and RIT Oncology, LLC, a wholly-owned subsidiary of Spectrum Pharmaceuticals, Inc.. (Filed as Exhibit 10.14 to Form 10-Q, No. 001-35006, as filed with the Securities and Exchange Commission on November 9, 2012, and incorporated herein by reference.)
|
|
|
|
10.45
|
|
License Agreement, dated May 23, 2006, by and between Merck Eprova AG and Spectrum Pharmaceuticals, Inc. (Filed as Exhibit 10.16 to Form 10-Q, No. 001-35006, as filed with the Securities and Exchange Commission on November 9, 2012, and incorporated herein by reference.)
|
|
|
|
10.46
|
|
First Amendment to License Agreement, dated June 20, 2014, by and between Spectrum Pharmaceuticals, Inc. and Merck Eprova AG. (Filed as Exhibit 99.1 to Form 8-K, No. 001-35006, as filed with the Securities and Exchange Commission on June 26, 2014, and incorporated herein by reference).
|
|
|
|
10.47
|
|
Manufacturing and Supply Agreement, dated May 23, 2006, by and between Merck Eprova AG and Spectrum Pharmaceuticals, Inc. (Filed as Exhibit 10.17 to Form 10-Q, No. 001-35006, as filed with the Securities and Exchange Commission on November 9, 2012, and incorporated herein by reference.)
|
|
|
|
10.48#
|
|
License Agreement, dated March 8, 2013, by and between Spectrum Pharmaceuticals, Inc. and CyDex Pharmaceuticals, Inc. (Filed as Exhibit 10.1 to Form 10-Q, No. 001-35006, as filed with the Securities and Exchange Commission on May 9, 2013, and incorporated herein by reference.)
|
|
|
|
10.49
|
|
Purchase Agreement, dated December 17, 2013, by and among Spectrum Pharmaceuticals, Inc., Jefferies LLC and RBC Capital Markets, LLC. (Filed as Exhibit 10.1 to Form 8-K, No. 001-35006, as filed with the Securities and Exchange Commission on December 23, 2013, and incorporated herein by reference.)
|
|
|
|
10.50
|
|
Base Call Option Transaction Confirmation, dated as of December 17, 2013, by and between Spectrum Pharmaceuticals, Inc. and Royal Bank of Canada. (Filed as Exhibit 10.2 to Form 8-K, No. 001-35006, as filed with the Securities and Exchange Commission on December 23, 2013, and incorporated herein by reference.)
|
|
|
|
10.51
|
|
Base Warrant Transaction Confirmation, dated December 17, 2013, by and between Spectrum Pharmaceuticals, Inc. and Royal Bank of Canada. (Filed as Exhibit 10.3 to Form 8-K, No. 001-35006, as filed with the Securities and Exchange Commission on December 23, 2013, and incorporated herein by reference.)
|
|
|
|
10.52
|
|
Additional Call Option Transaction Confirmation, dated December 20, 2013, by and between Spectrum Pharmaceuticals, Inc. and Royal Bank of Canada. (Filed as Exhibit 10.4 to Form 8-K, No. 001-35006, as filed with the Securities and Exchange Commission on December 23, 2013, and incorporated herein by reference.)
|
|
|
|
10.53
|
|
Additional Warrant Transaction Confirmation, dated December 20, 2013, by and between Spectrum Pharmaceuticals, Inc. and Royal Bank of Canada. (Filed as Exhibit 10.5 to Form 8-K, 001-35006, as filed with the Securities and Exchange Commission on December 23, 2013, and incorporated herein by reference.)
|
|
|
|
10.54#
|
|
Co-Promotion Agreement, dated November 4, 2015, by and between Eagle Pharmaceuticals, Inc. and Spectrum Pharmaceuticals, Inc., dated November 4, 2015. (Filed as Exhibit 10.54 to Form 10-K, No. 001-35006, as filed with the Securities and Exchange Commission on March 14, 2016, and incorporated herein by reference.)
|
|
|
|
10.55#
|
|
License and Asset Purchase Agreement, dated November 16, 2015, by and between Spectrum Pharmaceuticals Cayman, L.P. and Mundipharma International Corporation Limited, dated November 16, 2015. (Filed as Exhibit 10.55 to Form 10-K/A, No. 001-35006, as filed with the Securities and Exchange Commission on March 14, 2016, and incorporated herein by reference.)
|
|
|
|
10.56#
|
|
Supply Agreement, dated November 16, 2015, by and between Spectrum Pharmaceuticals Cayman, L.P. and Mundipharma Medical Company, dated November 16, 2015. (Filed as Exhibit 10.56 to Form 10-K, No. 001-35006, as filed with the Securities and Exchange Commission on March 14, 2016, and incorporated herein by reference.)
|
|
|
|
10.57
|
|
At Market Issuance Sales Agreement dated December 23, 2015, by and among Spectrum Pharmaceuticals, Inc., FBR Capital Markets & Co., MLV & Co. LLC and H.C. Wainwright & Co., LLC. (Filed as Exhibit 1.2 to Form S-3, Reg. No. 333-208760, as filed with the Securities and Exchange Commission on December 23, 2015, and incorporated herein by reference.)
|
|
|
|
10.58#
|
|
Amendment to License and Asset Purchase Agreement, dated February 29, 2016, by and between Spectrum Pharmaceuticals Cayman, L.P. and Bayer Pharma AG. (Filed as Exhibit 2.1 to Form 10-Q, No. 001-35006, as filed with the Securities and Exchange Commission on May 6, 2016, and incorporated herein by reference.)
|
|
|
|
10.59#
|
|
License Agreement dated March 8, 2013, by and between Spectrum Pharmaceuticals, Inc. and Cydex Pharmaceuticals, Inc. (Filed as Exhibit 10.1 to Form 10-Q, No. 001-35006, as filed with the Securities and Exchange Commission on August 9, 2016, and incorporated herein by reference.)
|
|
|
|
21.1+
|
|
Subsidiaries of Registrant.
|
|
|
|
23.1+
|
|
Consent of Independent Registered Public Accounting Firm (Deloitte & Touche LLP).
|
|
|
|
24.1+
|
|
Power of Attorney (included in the signature page)
|
|
|
|
31.1+
|
|
Certification of Principal Executive Officer, pursuant to Rule 13a-14(a)/15d-14(a) of the Securities Exchange Act of 1934.
|
|
|
|
31.2+
|
|
Certification of Principal Financial Officer, pursuant to Rule 13a-14(a)/15d-14(a) of the Securities Exchange Act of 1934.
|
|
|
|
32.1+
|
|
Certification of Principal Executive Officer, pursuant to Rule 13a-14(b)/15d-14(b) of the Securities Exchange Act of 1934 and 18 U.S.C. Section 1350.
|
|
|
|
32.2+
|
|
Certification of Principal Financial Officer, pursuant to Rule 13a-14(b)/15d-14(b) of the Securities Exchange Act of 1934 and 18 U.S.C. Section 1350.
|
|
|
|
101.INS+
|
|
XBRL Instance Document
|
|
|
|
101.SCH+
|
|
XBRL Taxonomy Extension Schema Document
|
|
|
|
101.CAL+
|
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
|
|
|
101.DEF+
|
|
XBRL Taxonomy Extension Definition Linkbase Document
|
|
|
|
101.LAB+
|
|
XBRL Taxonomy Extension Label Linkbase Document
|
|
|
|
101.PRE+
|
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
+
|
Filed herewith.
|
1 Year Spectrum Pharmaceuticals Chart |
1 Month Spectrum Pharmaceuticals Chart |
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