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Delaware
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|
93-0979187
|
(State or other jurisdiction of
incorporation or organization)
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|
(I.R.S. Employer
Identification No.)
|
Title of each class
|
Trading Symbol(s)
|
Name of each exchange on which registered
|
Common Stock, $0.001 par value
|
SPPI
|
The NASDAQ Global Select Market
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Large accelerated filer
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☒
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Accelerated filer
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☐
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||
Non-accelerated filer
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☐
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Smaller reporting company
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☐
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Emerging growth 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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|||
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|||
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|||
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|||
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PART III
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|||
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|||
PART IV
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|||
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|||
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|||
•
|
our ability to successfully develop, obtain regulatory approval, and market our products;
|
•
|
the approval, or timing of approval, of our products or new indications for our products by the U.S. Food and Drug Administration (the “FDA”) and other international regulatory agencies;
|
•
|
actions by the FDA and other regulatory agencies, including international agencies;
|
•
|
the timing and/or results of pending or future clinical trials, and our reliance on contract research organizations;
|
•
|
our ability to maintain sufficient cash resources to fund our business operations;
|
•
|
our history of net losses;
|
•
|
our ability to enter into strategic alliances with partners for manufacturing, development and commercialization;
|
•
|
our competitors’ progress with their drug development programs, which could adversely impact the perceived or actual value of our in-development drugs;
|
•
|
the ability of our manufacturing partners to meet our product demands and timelines;
|
•
|
our ability to identify and acquire new product candidates and to successfully integrate those product candidates into our operations;
|
•
|
our ability to protect our intellectual property rights;
|
•
|
the impact of legislative or regulatory reform on the pricing for pharmaceutical products;
|
•
|
the impact of any litigation to which we are, or may become a party;
|
•
|
our ability, and that of our suppliers, development partners, and manufacturing partners, to comply with laws, regulations and standards that govern or affect the pharmaceutical and biotechnology industries; and
|
•
|
our ability to maintain the services of our key executives and other personnel.
|
•
|
ROLONTIS, a novel long-acting granulocyte colony-stimulating (“G-CSF”) for chemotherapy-induced neutropenia which has been filed with the FDA and has a Prescription Drug User Fee Act (“PDUFA”) date of October 24, 2020;
|
•
|
Poziotinib, a novel irreversible tyrosine kinase inhibitor under investigation for non-small cell lung cancer (“NSCLC”) tumors with various mutations; and
|
•
|
Anti-CD20-IFNá, an antibody-interferon fusion molecule directed against CD20 that is in Phase 1 development for treating relapsed or refractory non-Hodgkin’s lymphoma (“NHL”) patients (including diffuse large B-cell lymphoma).
|
•
|
In 44 evaluable patients with EGFR exon-20 mutations, the confirmed overall response rate was 43% and disease control rate was 90%. Median progression free survival was 5.5 months.
|
•
|
In evaluable patients with HER2 exon-20 mutations, the confirmed overall response rate was 42% and disease control rate was 83%. Median progression free survival was 5.1 months.
|
•
|
EGFR-related toxicities (including rash, diarrhea, and paronychia) were manageable and required dose reductions in 60% of patients. Discontinuation due to poor tolerance was rare (approximately 3% of patients).
|
(a)
|
ROLONTIS is a novel long-acting granulocyte colony-stimulating factor that employs a proprietary technology that prolongs the duration of biologics, reducing the frequency of administration. There is currently one novel long-acting G-CSF and three biosimilar G-CSFs marketed in the United States including, Neulasta® (pegfilgrastim), marketed by Amgen, Inc., UDENYCA™ (pegfilgrastim-cbqv), a biosimilar marketed by Coherus BioSciences, Fulphila® (pegfilgrastim-jmdb), a biosimilar marketed by Mylan Pharmaceuticals, Inc., and Ziextenzo® (pegfilgrastim-bmez), a biosimilar marketed by Sandoz, which recently received FDA approval during the fourth quarter of 2019.
|
|
Research and Development Expenses for the Year Ended December 31,
(in thousands) |
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
ROLONTIS
|
$
|
21,920
|
|
|
$
|
31,612
|
|
|
$
|
20,254
|
|
Poziotinib
|
28,092
|
|
|
18,272
|
|
|
6,761
|
|
|||
Anti-CD20-IFNá
|
3,428
|
|
|
—
|
|
|
—
|
|
|||
Other in-development indications/drugs
|
145
|
|
|
151
|
|
|
153
|
|
|||
Total — Direct costs
|
53,585
|
|
|
50,035
|
|
|
27,168
|
|
|||
Add: General research and development expenses (including personnel costs that correspond to more than one in-development project)
|
25,747
|
|
|
25,122
|
|
|
24,357
|
|
|||
(Less): Reimbursements from development partners
|
(7
|
)
|
|
—
|
|
|
—
|
|
|||
Total research and development expenses from continuing operations
|
$
|
79,325
|
|
|
$
|
75,157
|
|
|
$
|
51,525
|
|
|
|
|
|
|
|
|
|
|
|||
Total research and development expenses included in discontinued operations (Note 12) for drug products sold as part of Commercial Product Portfolio Transaction
|
$
|
2,624
|
|
|
$
|
19,799
|
|
|
$
|
14,370
|
|
•
|
delays obtaining regulatory approval to commence a trial;
|
•
|
delays in reaching agreement on acceptable terms with contract research organizations, or CROs, and clinical trial sites;
|
•
|
delays in obtaining institutional review board, or IRB, approval at each site;
|
•
|
slower than anticipated patient enrollment or our inability to recruit and enroll patients to participate in clinical trials for various reasons;
|
•
|
our inability to retain patients who have initiated a clinical trial;
|
•
|
scheduling conflicts with participating clinicians and clinical institutions;
|
•
|
lack of funding to start or continue the clinical trial, including as a result of unforeseen costs due to enrollment delays, requirements to conduct additional trials and studies and increased expenses associated with our CROs and other third parties;
|
•
|
negative or inconclusive results;
|
•
|
deficiencies in the conduct of the clinical trial, including failure to conduct the clinical trial in accordance with regulatory requirements, good clinical practice, or clinical protocols;
|
•
|
deficiencies in the clinical trial operations or trial sites resulting in the imposition of a clinical hold;
|
•
|
patient noncompliance with the protocol;
|
•
|
adverse medical events or side effects experienced by patients during the clinical trials as a result of or resulting from the clinical trial treatments;
|
•
|
fatalities or other adverse events arising during a clinical trial due to medical problems that may not be related to clinical trial treatments;
|
•
|
our ability to sustain the quality or stability of the applicable product candidate in compliance with acceptable standards;
|
•
|
our inability to produce or obtain sufficient quantities of the applicable product candidate to complete the clinical trials;
|
•
|
changes in governmental regulations or administrative actions that adversely affect our ability to continue to conduct or complete clinical trials;
|
•
|
negative or problematic FDA inspections of our clinical operations or manufacturing operations; and
|
•
|
real or perceived lack of effectiveness or safety.
|
•
|
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;
|
•
|
not purchase sufficient inventory on hand to fulfill end user orders in a timely manner;
|
•
|
be unable to satisfy financial obligations to us or others; and
|
•
|
cease operations.
|
•
|
risks associated with satisfying the closing conditions relating to such transactions and realizing their anticipated benefits;
|
•
|
increased operating expenses and cash requirements;
|
•
|
difficulty in conforming standards, procedures and policies, business cultures and compensation structures;
|
•
|
difficulty integrating acquired technologies, products and personnel with our existing business;
|
•
|
difficulty conforming acquired operations, such as corporate and administrative functions, sales and marketing, or information technology and accounting systems with our existing business;
|
•
|
diversion of management’s attention in connection with both negotiating the acquisition or license and integrating the business, technology or product;
|
•
|
retention of key employees
|
•
|
uncertainties in our ability to maintain key business relationships of any acquired entities;
|
•
|
strain on managerial and operational resources;
|
•
|
exposure to regulatory, compliance and legal risks of the acquired entities;
|
•
|
tax costs or inefficiencies associated with integrating operations;
|
•
|
modifications to operating control standards to comply with the Sarbanes-Oxley Act of 2002 and the rules and regulations promulgated thereunder;
|
•
|
difficulty coordinating geographically dispersed organizations;
|
•
|
exposure to unforeseen liabilities of acquired companies or products or companies or products in which we invest; and
|
•
|
potential costly and time-consuming litigation, including stockholder lawsuits.
|
•
|
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;
|
•
|
uncertainty regarding ownership of intellectual property rights arising from our collaborative activities, which could prevent us from entering into additional collaborations;
|
•
|
unwillingness to cooperate in the manufacture of the product, including providing us with product data or materials;
|
•
|
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;
|
•
|
initiation of litigation or alternative dispute resolution options by either party to resolve the dispute;
|
•
|
attempts by either party to terminate the collaboration;
|
•
|
our ability to maintain or defend our intellectual property rights may be compromised by our partner’s acts or omissions;
|
•
|
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;
|
•
|
a third-party development partner may change the focus of its development and commercialization efforts due to internal reorganizations, mergers, consolidations or otherwise;
|
•
|
unwillingness to fully fund or commit sufficient resources to the testing, marketing, distribution or development of our products;
|
•
|
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
|
•
|
we may not be able to guarantee supplies of development or marketed products.
|
•
|
interpretations of existing tax laws;
|
•
|
the accounting for stock options and other share-based compensation;
|
•
|
changes in tax laws and rates;
|
•
|
future levels of research and development spending;
|
•
|
changes in accounting standards;
|
•
|
changes in the mix of earnings in the various tax jurisdictions in which we operate;
|
•
|
the outcome of examinations by the Internal Revenue Service and tax regulators in other jurisdictions;
|
•
|
the accuracy of our estimates for unrecognized tax benefits;
|
•
|
realization of deferred tax assets; and
|
•
|
changes in overall levels of pre-tax earnings.
|
•
|
comply with FDA regulations or similar regulations of similar regulatory authorities in other countries;
|
•
|
provide accurate information to the FDA or similar regulatory authorities in other countries;
|
•
|
comply with manufacturing standards we, the FDA or similar authorities in other countries have established;
|
•
|
comply with federal and state healthcare fraud and abuse laws and regulations or similar laws and regulations
|
•
|
established and enforced by comparable foreign regulatory authorities;
|
•
|
comply with the provisions of the Foreign Corrupt Practices Act, or the FCPA; or
|
•
|
report financial information or clinical or preclinical data accurately.
|
•
|
the inability to obtain necessary foreign regulatory or pricing approvals of products in a timely manner;
|
•
|
collectability of accounts receivable;
|
•
|
fluctuations in foreign currency exchange rates, in particular the recent strength of the U.S. dollar versus foreign currencies that has adversely impacted our revenues and net income;
|
•
|
difficulties in staffing and managing international operations;
|
•
|
the imposition of governmental controls;
|
•
|
less favorable intellectual property or other applicable laws;
|
•
|
increasingly complex standards for complying with foreign laws and regulations that may differ substantially from country to country and may conflict with corresponding U.S. laws and regulations;
|
•
|
the far-reaching anti-bribery and anti-corruption legislation in the U.K., including the U.K. Bribery Act 2010, and elsewhere and escalation of investigations and prosecutions pursuant to such laws;
|
•
|
compliance with complex import and export control laws;
|
•
|
restrictions on direct investments by foreign entities and trade restrictions;
|
•
|
greater political or economic instability; and
|
•
|
changes in tax laws and tariffs.
|
•
|
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;
|
•
|
we or our licensors might not have been the first to file patent applications for these inventions;
|
•
|
others may independently develop similar or alternative product candidates or duplicate any of our or our licensors’ product candidates;
|
•
|
our or our licensors’ pending patent applications may not result in issued patents;
|
•
|
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;
|
•
|
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;
|
•
|
we may not develop or in-license additional patentable proprietary technologies related to our product candidates; or
|
•
|
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.
|
•
|
pay damages, including up to treble damages and the other party’s attorneys’ fees, which may be substantial;
|
•
|
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;
|
•
|
expend significant resources to redesign our products so they do not infringe others’ patent rights, which may not be possible;
|
•
|
discontinue manufacturing or other processes incorporating infringing technology; or
|
•
|
obtain licenses to the infringed intellectual property, which may not be available to us on acceptable terms, or at all.
|
•
|
the effectiveness of the drug product;
|
•
|
the prevalence and severity of any side effects;
|
•
|
potential advantages or disadvantages over alternative treatments;
|
•
|
relative convenience and ease of administration;
|
•
|
the strength of marketing and distribution support;
|
•
|
the price of the drug product, both in absolute terms and relative to alternative treatments; and
|
•
|
sufficient third-party coverage and reimbursement.
|
•
|
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;
|
•
|
mandate labeling changes to products, at any point in a product’s lifecycle, based on new safety information; and
|
•
|
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 the FDA deems necessary to assure safe use of the drug (either prior to approval or post-approval as necessary).
|
•
|
a covered benefit under its health plan;
|
•
|
safe, effective and medically necessary;
|
•
|
appropriate for the specific patient;
|
•
|
cost-effective; and
|
•
|
neither experimental nor investigational.
|
•
|
adverse results or delays in our clinical trials;
|
•
|
fluctuations in our results of operations;
|
•
|
timing and announcements of our technological innovations or new products or those of our competitors;
|
•
|
developments concerning any strategic alliances or acquisitions we may enter into;
|
•
|
announcements of FDA non-approval of our products, or delays in the FDA or other foreign regulatory review processes or actions;
|
•
|
changes in recommendations or guidelines of government agencies or other third parties regarding the use of our products;
|
•
|
adverse actions taken by regulatory agencies with respect to our drug products, clinical trials, manufacturing processes or sales and marketing activities;
|
•
|
concerns about our in-development products being reimbursed at requisite levels in the future;
|
•
|
any lawsuit involving us or our products;
|
•
|
developments with respect to our patents and proprietary rights;
|
•
|
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;
|
•
|
failure of our results of operations to meet the expectations of stock market analysts and investors;
|
•
|
sales of our common stock by our executive officers, directors and significant stockholders or sales of substantial amounts of our common stock generally; and
|
•
|
loss of any of our key scientific or management personnel.
|
•
|
the ability of our Board of Directors to amend our bylaws without stockholder approval;
|
•
|
the inability of stockholders to call special meetings;
|
•
|
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
|
•
|
the establishment of advance notice requirements for the nomination of candidates for election to our Board of Directors or for proposing matters that can be acted on by stockholders at stockholder meetings.
|
ACADIA Pharmaceuticals
|
Luminex
|
Aerie Pharmaceuticals
|
Momenta Pharmaceuticals
|
Amicus Therapeutics
|
Omeros
|
Clovis Oncology
|
Pacira Pharmaceuticals
|
Corcept Therapeutics
|
PTC Therapeutics
|
Eagle Pharmaceuticals
|
Repligen
|
Halozyme Therapeutics
|
Retrophin
|
Heron Therapeutics
|
Supernus Pharmaticeuticals
|
Intercept Pharmaceuticals
|
Theravance Biopharma
|
Ironwood Pharmaceuticals
|
Vanda Pharmaceuticals
|
Lexicon Pharmaceuticals
|
|
|
|
12/31/2015
|
|
12/31/2016
|
|
12/31/2017
|
|
12/31/2018
|
|
12/31/2019
|
||||||||||
Spectrum Pharmaceuticals, Inc.
|
|
$
|
88
|
|
|
$
|
67
|
|
|
$
|
294
|
|
|
$
|
138
|
|
|
$
|
60
|
|
Russell 2000
|
|
$
|
96
|
|
|
$
|
116
|
|
|
$
|
133
|
|
|
$
|
118
|
|
|
$
|
148
|
|
2019 Peer Group
|
|
$
|
108
|
|
|
$
|
94
|
|
|
$
|
114
|
|
|
$
|
95
|
|
|
$
|
113
|
|
(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:
|
2019
|
|
2018
|
|
2017
|
|
2016
|
|
2015
|
||||||||||
|
(In thousands, except per share data)
|
||||||||||||||||||
Revenues (Note 1(b))
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Operating costs and expenses:
|
|
|
|
|
|
|
|
|
|
||||||||||
Selling, general and administrative
|
61,373
|
|
|
62,690
|
|
|
64,759
|
|
|
60,322
|
|
|
63,986
|
|
|||||
Research and development
|
79,325
|
|
|
75,157
|
|
|
51,525
|
|
|
42,436
|
|
|
39,781
|
|
|||||
Loss from continuing operations before other (expense) income and income taxes
|
(140,698
|
)
|
|
(137,847
|
)
|
|
(116,284
|
)
|
|
(102,758
|
)
|
|
(103,767
|
)
|
|||||
|
|
|
|
|
|
|
|
|
|
||||||||||
Basic and diluted loss per share:
|
|
|
|
|
|
|
|
|
|
||||||||||
Loss per common share from continuing operations before other (expense) income and income taxes
|
$
|
(1.27
|
)
|
|
$
|
(1.33
|
)
|
|
$
|
(1.37
|
)
|
|
$
|
(1.41
|
)
|
|
$
|
(1.60
|
)
|
|
As of December 31,
|
||||||||||||||||||
Selected Balance Sheet Data:
|
2019
|
|
2018
|
|
2017
|
|
2016
|
|
2015
|
||||||||||
|
(In thousands)
|
||||||||||||||||||
Cash, cash equivalents and marketable securities
|
$
|
223,873
|
|
|
$
|
203,988
|
|
|
$
|
227,571
|
|
|
$
|
158,469
|
|
|
$
|
139,986
|
|
Total assets
|
$
|
263,433
|
|
|
$
|
390,886
|
|
|
$
|
487,439
|
|
|
$
|
428,768
|
|
|
$
|
419,049
|
|
Long term obligations, less current portion
|
$
|
11,070
|
|
|
$
|
21,150
|
|
|
$
|
26,351
|
|
|
$
|
127,229
|
|
|
$
|
129,849
|
|
•
|
ROLONTIS, a novel long-acting granulocyte colony-stimulating (“G-CSF”) for chemotherapy-induced neutropenia which has been filed with the FDA and has a Prescription Drug User Fee Act (“PDUFA”) date of October 24, 2020;
|
•
|
Poziotinib, a novel irreversible tyrosine kinase inhibitor under investigation for non-small cell lung cancer (“NSCLC”) tumors with various mutations; and
|
•
|
Anti-CD20-IFNá, an antibody-interferon fusion molecule directed against CD20 that is in Phase 1 development for treating relapsed or refractory non-Hodgkin’s lymphoma patients (including diffuse large B-cell lymphoma).
|
•
|
Company Overview
|
•
|
Cancer Background and Market Size
|
•
|
Product Portfolio
|
•
|
Manufacturing
|
•
|
Competition
|
•
|
Research and Development
|
•
|
Revenue recognition;
|
•
|
Income taxes;
|
•
|
Stock-based compensation; and
|
•
|
Litigation accruals (as required).
|
(1)
|
we ensure that we have an executed contract(s) with our customer that we believe is legally enforceable;
|
(2)
|
we identify the “performance obligations” in the respective contract;
|
(3)
|
we determine the “transaction price” for each performance obligation in the respective contract;
|
(4)
|
we allocate the transaction price to each performance obligation; and
|
(5)
|
we recognize revenue only when we satisfy each performance obligation.
|
•
|
When our licensee is responsible for the achievement of the regulatory milestone, we recognize revenue in full (for the contractual amount due from our licensee) in the period that the approval occurs (i.e., when the “performance obligation” is satisfied by our customer) under the “most likely amount” method. This revenue recognition remains “constrained” (i.e., not recognized) until regulatory approval occurs, given its inherent uncertainty and the requirement of a significant revenue reversal not being probable if achievement does not occur. At each reporting period, we re-evaluate the probability of milestone achievement and the associated revenue constraint; any resulting adjustments would be recorded on a cumulative catch-up basis, thus reflected in our financial statements in the period of adjustment.
|
•
|
When we are responsible for the achievement of a regulatory milestone, the “relative selling price method” is applied for purposes of allocating the transaction price to our performance obligations. In such case, we consider (i) the extent of our effort to achieve the milestone and/or the enhancement of the value of the delivered item(s) as a result of milestone achievement and (ii) if the milestone payment is reasonable relative to all of the deliverables and payment terms (including other potential milestone consideration) within the arrangement. We have historically assessed the contractual value of these milestones upon their achievement to be identical to the allocation of value of our performance obligations and thus representing the “transaction price” for each milestone at contract inception. We recognize this revenue in the period that the regulatory approval occurs (i.e., when we complete the “performance obligation”) under the “most likely amount” method, and revenue recognition is otherwise “constrained” until regulatory approval occurs, given its inherent uncertainty and the requirement of a significant revenue reversal not being probable if achievement does not occur. At each reporting period, we re-evaluate the probability of milestone achievement and the associated revenue constraint; any resulting adjustments would be recorded on a cumulative catch-up basis, thus reflected in our financial statements in the period of adjustment.
|
|
Year Ended December 31,
|
||||||||||
|
2019
|
2018
|
2017
|
||||||||
|
($ in thousands)
|
||||||||||
Revenues (Note 1(b))
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Operating costs and expenses:
|
|
|
|
|
|
||||||
Selling, general and administrative
|
61,373
|
|
|
62,690
|
|
|
64,759
|
|
|||
Research and development
|
79,325
|
|
|
75,157
|
|
|
51,525
|
|
|||
Total operating costs and expenses
|
140,698
|
|
|
137,847
|
|
|
116,284
|
|
|||
Loss from continuing operations before other (expense) income and income taxes
|
(140,698
|
)
|
|
(137,847
|
)
|
|
(116,284
|
)
|
|||
Other (expense) income :
|
|
|
|
|
|
|
|
|
|||
Interest income (expense), net
|
4,996
|
|
|
(340
|
)
|
|
(6,798
|
)
|
|||
Other (expense) income, net
|
(8,892
|
)
|
|
9,580
|
|
|
389
|
|
|||
Total other (expense) income
|
(3,896
|
)
|
|
9,240
|
|
|
(6,409
|
)
|
|||
Loss from continuing operations before income taxes
|
(144,594
|
)
|
|
(128,607
|
)
|
|
(122,693
|
)
|
|||
Benefit for income taxes from continuing operations
|
9,208
|
|
|
1,901
|
|
|
21,941
|
|
|||
Loss from continuing operations
|
(135,386
|
)
|
|
(126,706
|
)
|
|
(100,752
|
)
|
|||
Income from discontinued operations, net of income taxes (Notes 12 and 15)
|
22,697
|
|
|
5,965
|
|
|
8,563
|
|
|||
Net loss
|
$
|
(112,689
|
)
|
|
$
|
(120,741
|
)
|
|
$
|
(92,189
|
)
|
|
Year Ended December 31,
|
|
|
|
|
|||||||||
|
2019
|
|
2018
|
|
$ Change
|
|
% Change
|
|||||||
|
($ in millions)
|
|
|
|
|
|||||||||
Operating expenses:
|
|
|
|
|
|
|
|
|||||||
Selling, general and administrative
|
61.4
|
|
|
62.7
|
|
|
(1.3
|
)
|
|
(2.1
|
)%
|
|||
Research and development
|
79.3
|
|
|
75.2
|
|
|
4.1
|
|
|
5.5
|
%
|
|||
Total operating costs and expenses
|
$
|
140.7
|
|
|
$
|
137.8
|
|
|
$
|
2.9
|
|
|
2.1
|
%
|
|
Year Ended December 31,
|
|
|
|
|
|||||||||
|
2019
|
|
2018
|
|
$ Change
|
|
% Change
|
|||||||
|
($ in millions)
|
|
|
|
|
|||||||||
Total other (expense) income
|
$
|
(3.9
|
)
|
|
$
|
9.2
|
|
|
$
|
(13.1
|
)
|
|
142.4
|
%
|
|
Year Ended December 31,
|
|
|
|
|
|||||||||
|
2019
|
|
2018
|
|
$ Change
|
|
% Change
|
|||||||
|
($ in millions)
|
|
|
|
|
|||||||||
Benefit for income taxes from continuing operations
|
$
|
9.2
|
|
|
$
|
1.9
|
|
|
$
|
7.3
|
|
|
384.2
|
%
|
|
Year Ended December 31,
|
|
|
|
|
|||||||||
|
2018
|
|
2017
|
|
$ Change
|
|
% Change
|
|||||||
|
($ in millions)
|
|
|
|
|
|||||||||
Operating expenses:
|
|
|
|
|
|
|
|
|||||||
Selling, general and administrative
|
$
|
62.7
|
|
|
$
|
64.8
|
|
|
$
|
(2.1
|
)
|
|
(3.2
|
)%
|
Research and development
|
75.2
|
|
|
51.5
|
|
|
23.7
|
|
|
46.0
|
%
|
|||
Total operating costs and expenses
|
$
|
137.8
|
|
|
$
|
116.3
|
|
|
$
|
21.5
|
|
|
18.5
|
%
|
|
Year Ended December 31,
|
|
|
|
|
|||||||||
|
2018
|
|
2017
|
|
$ Change
|
|
% Change
|
|||||||
|
($ in millions)
|
|
|
|
|
|||||||||
Total other income (expense)
|
$
|
9.2
|
|
|
$
|
(6.4
|
)
|
|
$
|
15.6
|
|
|
(243.8
|
)%
|
|
Year Ended December 31,
|
|
|
|
|
|||||||||
|
2018
|
|
2017
|
|
$ Change
|
|
% Change
|
|||||||
|
($ in millions)
|
|
|
|
|
|||||||||
Benefit for income taxes from continuing operations
|
$
|
1.9
|
|
|
$
|
21.9
|
|
|
$
|
(20.0
|
)
|
|
(91.3
|
)%
|
|
December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
|
(in thousands, except financial
metrics data) |
||||||||||
Cash, cash equivalents and marketable securities
|
$
|
223,873
|
|
|
$
|
203,988
|
|
|
$
|
227,571
|
|
Accounts receivable, net
|
$
|
441
|
|
|
$
|
29,873
|
|
|
$
|
32,260
|
|
Total current assets
|
$
|
244,020
|
|
|
$
|
250,688
|
|
|
$
|
277,746
|
|
Total current liabilities
|
$
|
61,970
|
|
|
$
|
98,326
|
|
|
$
|
120,870
|
|
Working capital surplus (a)
|
$
|
182,050
|
|
|
$
|
152,362
|
|
|
$
|
156,876
|
|
Current ratio (b)
|
3.9
|
|
|
2.5
|
|
|
2.3
|
|
(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)
|
$
|
4,520
|
|
|
$
|
1,934
|
|
|
$
|
2,499
|
|
|
$
|
87
|
|
|
$
|
—
|
|
Purchase obligations (2)
|
77,413
|
|
|
39,910
|
|
|
24,385
|
|
|
10,884
|
|
|
2,234
|
|
|||||
Contingent milestone obligations (3)
|
571,912
|
|
|
10,250
|
|
|
18,100
|
|
|
7,750
|
|
|
535,812
|
|
|||||
Total
|
$
|
653,845
|
|
|
$
|
52,094
|
|
|
$
|
44,984
|
|
|
$
|
18,721
|
|
|
$
|
538,046
|
|
(1)
|
The operating lease obligations are primarily related to the facility lease for our corporate headquarters in Henderson, Nevada, expiring October 31, 2021; our research and development and administrative facility in Irvine, California, expiring July 31, 2022.
|
(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, 2019.
|
(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.
|
Spectrum Pharmaceuticals, Inc.
|
||
|
|
|
By:
|
|
/s/ JOSEPH W. TURGEON
|
|
|
Joseph W. Turgeon
|
|
|
President and Chief Executive Officer
|
Signature
|
Title
|
Dates
|
|
|
|
/s/ JOSEPH W. TURGEON
|
President and Chief Executive Officer
|
March 2, 2020
|
Joseph W. Turgeon
|
|
|
|
|
|
/s/ KURT A. GUSTAFSON
|
Executive Vice President and Chief Financial Officer (Principal Financial and Accounting Officer)
|
March 2, 2020
|
Kurt A. Gustafson
|
|
|
|
|
|
/s/ WILLIAM L. ASHTON
|
Chairman of the Board
|
March 2, 2020
|
William L. Ashton
|
|
|
|
|
|
/s/ DOLATRAI M. VYAS, PH.D.
|
Director
|
March 2, 2020
|
Dolatrai M. Vyas, Ph.D.
|
|
|
|
|
|
/s/ BERNICE R. WELLES, M.D., M.B.A.
|
Director
|
March 2, 2020
|
Bernice R. Welles, M.D., M.B.A.
|
|
|
|
|
|
/s/ ELIZABETH A. CZEREPAK
|
Director
|
March 2, 2020
|
Elizabeth A. Czerepak
|
|
|
|
|
|
/s/ RAYMOND W. COHEN
|
Director
|
March 2, 2020
|
Raymond W. Cohen
|
|
|
|
|
|
/s/ JEFFREY L. VACIRCA, M.D., F.A.C.P.
|
Director
|
March 2, 2020
|
Jeffrey L. Vacirca, M.D., F.A.C.P.
|
|
|
|
|
|
|
|
|
|
|
Page
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
|
December 31,
|
||||||
|
2019
|
|
2018
|
||||
ASSETS
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
64,418
|
|
|
$
|
157,480
|
|
Marketable securities
|
159,455
|
|
|
46,508
|
|
||
Accounts receivable, net of allowance for doubtful accounts of $43 and $67, respectively
|
441
|
|
|
29,873
|
|
||
Other receivables
|
9,558
|
|
|
3,698
|
|
||
Prepaid expenses and other assets
|
10,148
|
|
|
7,574
|
|
||
Discontinued operations, current assets (Note 12)
|
—
|
|
|
5,555
|
|
||
Total current assets
|
244,020
|
|
|
250,688
|
|
||
Property and equipment, net of accumulated depreciation
|
11,607
|
|
|
385
|
|
||
Other assets
|
4,000
|
|
|
7,188
|
|
||
Facility and equipment under lease
|
3,806
|
|
|
—
|
|
||
Discontinued operations, non-current assets
|
—
|
|
|
132,625
|
|
||
Total assets
|
$
|
263,433
|
|
|
$
|
390,886
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
|
|
|
||||
Current liabilities:
|
|
|
|
||||
Accounts payable and other accrued liabilities
|
$
|
54,284
|
|
|
$
|
81,312
|
|
Accrued payroll and benefits
|
7,686
|
|
|
9,853
|
|
||
Contract liabilities
|
—
|
|
|
4,850
|
|
||
Discontinued operations, current liabilities (Note 12)
|
—
|
|
|
2,311
|
|
||
Total current liabilities
|
61,970
|
|
|
98,326
|
|
||
Deferred tax liabilities, net
|
—
|
|
|
1,469
|
|
||
Other long-term liabilities
|
11,070
|
|
|
5,650
|
|
||
Discontinued operations, non-current liabilities
|
—
|
|
|
14,031
|
|
||
Total liabilities
|
73,040
|
|
|
119,476
|
|
||
Commitments and contingencies (Note 10)
|
|
|
|
||||
Stockholders’ equity:
|
|
|
|
||||
Preferred stock, $0.001 par value; 5,000,000 shares authorized; no shares issued and outstanding
|
—
|
|
|
—
|
|
||
Common stock, $0.001 par value; 300,000,000 shares authorized; 113,299,612 and 110,525,141 issued and outstanding at December 31, 2019 and 2018, respectively
|
113
|
|
|
110
|
|
||
Additional paid-in capital
|
918,205
|
|
|
886,740
|
|
||
Accumulated other comprehensive loss
|
(3,498
|
)
|
|
(3,702
|
)
|
||
Accumulated deficit
|
(724,427
|
)
|
|
(611,738
|
)
|
||
Total stockholders’ equity
|
190,393
|
|
|
271,410
|
|
||
Total liabilities and stockholders’ equity
|
$
|
263,433
|
|
|
$
|
390,886
|
|
|
Year Ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
Revenues (Note 1(b))
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Operating costs and expenses:
|
|
|
|
|
|
||||||
Selling, general and administrative
|
61,373
|
|
|
62,690
|
|
|
64,759
|
|
|||
Research and development
|
79,325
|
|
|
75,157
|
|
|
51,525
|
|
|||
Total operating costs and expenses
|
140,698
|
|
|
137,847
|
|
|
116,284
|
|
|||
Loss from continuing operations before other (expense) income and income taxes
|
(140,698
|
)
|
|
(137,847
|
)
|
|
(116,284
|
)
|
|||
Other (expense) income :
|
|
|
|
|
|
||||||
Interest income (expense), net
|
4,996
|
|
|
(340
|
)
|
|
(6,798
|
)
|
|||
Other (expense) income, net
|
(8,892
|
)
|
|
9,580
|
|
|
389
|
|
|||
Total other (expense) income
|
(3,896
|
)
|
|
9,240
|
|
|
(6,409
|
)
|
|||
Loss from continuing operations before income taxes
|
(144,594
|
)
|
|
(128,607
|
)
|
|
(122,693
|
)
|
|||
Benefit for income taxes from continuing operations
|
9,208
|
|
|
1,901
|
|
|
21,941
|
|
|||
Loss from continuing operations
|
$
|
(135,386
|
)
|
|
$
|
(126,706
|
)
|
|
$
|
(100,752
|
)
|
Income from discontinued operations, net of income taxes (Notes 12 and 15)
|
22,697
|
|
|
5,965
|
|
|
8,563
|
|
|||
Net loss
|
$
|
(112,689
|
)
|
|
$
|
(120,741
|
)
|
|
$
|
(92,189
|
)
|
|
|
|
|
|
|
||||||
Basic and diluted (loss) income per share:
|
|
|
|
|
|
||||||
Loss per common share from continuing operations
|
$
|
(1.22
|
)
|
|
$
|
(1.23
|
)
|
|
$
|
(1.18
|
)
|
Income per common share from discontinued operations
|
$
|
0.21
|
|
|
$
|
0.06
|
|
|
$
|
0.10
|
|
Net loss per common share
|
$
|
(1.02
|
)
|
|
$
|
(1.17
|
)
|
|
$
|
(1.08
|
)
|
|
|
|
|
|
|
||||||
Weighted average shares outstanding:
|
|
|
|
|
|
||||||
Basic
|
110,585,768
|
|
|
103,305,911
|
|
|
85,115,592
|
|
|||
Diluted
|
110,585,768
|
|
|
103,305,911
|
|
|
85,115,592
|
|
|
Year Ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
Net loss
|
$
|
(112,689
|
)
|
|
$
|
(120,741
|
)
|
|
$
|
(92,189
|
)
|
Other comprehensive income (loss):
|
|
|
|
|
|
||||||
Unrealized gain on available-for-sale securities, net of income tax expense of $0.2 million, $0, and $9.7 million for the years ended December 31, 2019, 2018, and 2017, respectively (see Note 3(a))
|
622
|
|
|
—
|
|
|
16,039
|
|
|||
Foreign currency translation adjustments
|
(418
|
)
|
|
(2,490
|
)
|
|
1,539
|
|
|||
Other comprehensive income (loss)
|
204
|
|
|
(2,490
|
)
|
|
17,578
|
|
|||
Total comprehensive loss
|
$
|
(112,485
|
)
|
|
$
|
(123,231
|
)
|
|
$
|
(74,611
|
)
|
|
Common Stock
|
|
Additional
Paid-In Capital |
|
Accumulated
Other Comprehensive (Loss) Income |
|
Accumulated
Deficit |
|
Total
Stockholders' Equity |
|||||||||||||
|
Shares
|
|
Amount
|
|
|
|
|
|||||||||||||||
Balance as of December 31, 2016
|
80,466,735
|
|
|
$
|
80
|
|
|
$
|
648,384
|
|
|
$
|
(1,579
|
)
|
|
$
|
(421,040
|
)
|
|
$
|
225,845
|
|
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(92,189
|
)
|
|
(92,189
|
)
|
|||||
Other comprehensive income, net
|
—
|
|
|
—
|
|
|
—
|
|
|
17,578
|
|
|
—
|
|
|
17,578
|
|
|||||
Recognition of stock-based compensation expense
|
—
|
|
|
—
|
|
|
14,227
|
|
|
—
|
|
|
—
|
|
|
14,227
|
|
|||||
Issuance of common stock to 401(k) plan for employees
|
102,874
|
|
|
—
|
|
|
912
|
|
|
—
|
|
|
—
|
|
|
912
|
|
|||||
Issuance of common stock for employee stock purchase plan
|
203,229
|
|
|
—
|
|
|
1,010
|
|
|
—
|
|
|
—
|
|
|
1,010
|
|
|||||
Issuance of common stock upon exercise of stock options, net
|
864,897
|
|
|
1
|
|
|
5,477
|
|
|
—
|
|
|
—
|
|
|
5,478
|
|
|||||
Restricted stock award grants, net of forfeitures
|
548,394
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Repurchase/retirement of restricted stock awards to satisfy employee tax withholding
|
(373,822
|
)
|
|
—
|
|
|
(4,331
|
)
|
|
—
|
|
|
—
|
|
|
(4,331
|
)
|
|||||
Issuance of common shares under an at-the-market sales agreement (Note 5)
|
13,558,132
|
|
|
14
|
|
|
128,258
|
|
|
—
|
|
|
—
|
|
|
128,272
|
|
|||||
Conversion hedge unwind in connection with open market purchases of 2018 Convertible Notes (Note 9)
|
5,372,296
|
|
|
5
|
|
|
43,410
|
|
|
—
|
|
|
—
|
|
|
43,415
|
|
|||||
Balance as of December 31, 2017
|
100,742,735
|
|
|
$
|
100
|
|
|
$
|
837,347
|
|
|
$
|
15,999
|
|
|
$
|
(513,229
|
)
|
|
$
|
340,217
|
|
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(120,741
|
)
|
|
(120,741
|
)
|
|||||
Cumulative-effect adjustment of ASU 2016-01 adoption (Note 3(a))
|
—
|
|
|
—
|
|
|
—
|
|
|
(17,211
|
)
|
|
17,211
|
|
|
—
|
|
|||||
Cumulative-effect adjustment of Topic 606 adoption
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
4,678
|
|
|
4,678
|
|
|||||
Foreign currency adjustment related to new adoptions
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
343
|
|
|
343
|
|
|||||
Other comprehensive loss, net
|
—
|
|
|
—
|
|
|
—
|
|
|
(2,490
|
)
|
|
—
|
|
|
(2,490
|
)
|
|||||
Recognition of stock-based compensation expense
|
—
|
|
|
—
|
|
|
16,309
|
|
|
—
|
|
|
—
|
|
|
16,309
|
|
|||||
Issuance of common stock to 401(k) plan for employees
|
70,379
|
|
|
—
|
|
|
1,175
|
|
|
—
|
|
|
—
|
|
|
1,175
|
|
|||||
Issuance of common stock for employee stock purchase plan
|
97,804
|
|
|
—
|
|
|
1,122
|
|
|
—
|
|
|
—
|
|
|
1,122
|
|
|||||
Issuance of common stock upon exercise of stock options
|
7,858,141
|
|
|
8
|
|
|
52,977
|
|
|
—
|
|
|
—
|
|
|
52,985
|
|
|||||
Restricted stock award grants, net of forfeitures
|
874,532
|
|
|
1
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1
|
|
|||||
Repurchase/retirement of restricted stock awards to satisfy employee tax withholding
|
(3,463,873
|
)
|
|
(3
|
)
|
|
(62,541
|
)
|
|
—
|
|
|
—
|
|
|
(62,544
|
)
|
|||||
Issuance of common stock upon vesting of restricted stock units
|
200,652
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Issuance of common stock upon exercise of warrants
|
292,575
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Common stock redeemed on 2018 Convertible Notes (Note 9)
|
3,852,196
|
|
|
4
|
|
|
40,351
|
|
|
—
|
|
|
—
|
|
|
40,355
|
|
|||||
Balance as of December 31, 2018
|
110,525,141
|
|
|
$
|
110
|
|
|
$
|
886,740
|
|
|
$
|
(3,702
|
)
|
|
$
|
(611,738
|
)
|
|
$
|
271,410
|
|
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(112,689
|
)
|
|
(112,689
|
)
|
|||||
Other comprehensive loss, net
|
—
|
|
|
—
|
|
|
—
|
|
|
204
|
|
|
—
|
|
|
204
|
|
|||||
Recognition of stock-based compensation expense
|
—
|
|
|
—
|
|
|
20,416
|
|
|
—
|
|
|
—
|
|
|
20,416
|
|
|||||
Issuance of common stock to 401(k) plan for employees
|
225,780
|
|
|
—
|
|
|
1,422
|
|
|
—
|
|
|
—
|
|
|
1,422
|
|
|||||
Issuance of common stock for employee stock purchase plan
|
131,966
|
|
|
—
|
|
|
663
|
|
|
—
|
|
|
—
|
|
|
663
|
|
|||||
Issuance of common stock upon exercise of stock options
|
1,121,403
|
|
|
2
|
|
|
7,147
|
|
|
—
|
|
|
—
|
|
|
7,149
|
|
|||||
Restricted stock award grants, net of forfeitures
|
830,033
|
|
|
1
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1
|
|
|||||
Issuance of common stock upon vesting of restricted stock units
|
243,760
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Issuance of common shares under an at-the-market sales agreement (Note 5)
|
221,529
|
|
|
|
|
|
1,817
|
|
|
—
|
|
|
—
|
|
|
1,817
|
|
|||||
Balance as of December 31, 2019
|
113,299,612
|
|
|
$
|
113
|
|
|
$
|
918,205
|
|
|
$
|
(3,498
|
)
|
|
$
|
(724,427
|
)
|
|
$
|
190,393
|
|
|
Year Ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
Cash Flows From Operating Activities:
|
|
|
|
|
|
||||||
Loss from continuing operations
|
(135,386
|
)
|
|
(126,706
|
)
|
|
(100,752
|
)
|
|||
Income from discontinued operations, net of income taxes (Note 12)
|
22,697
|
|
|
5,965
|
|
|
8,563
|
|
|||
Net loss
|
(112,689
|
)
|
|
(120,741
|
)
|
|
(92,189
|
)
|
|||
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
||||||
Depreciation and amortization
|
1,620
|
|
|
28,409
|
|
|
27,972
|
|
|||
Stock-based compensation (Note 4)
|
21,838
|
|
|
17,483
|
|
|
15,139
|
|
|||
Recognized gain on Commercial Product Portfolio Transaction (Note 12)
|
(34,568
|
)
|
|
—
|
|
|
—
|
|
|||
Amortization of operating leases (Note 10(a))
|
1,715
|
|
|
—
|
|
|
—
|
|
|||
Amortization of discount on investments in debt securities, recorded to interest income (Note 3(a))
|
(431
|
)
|
|
—
|
|
|
—
|
|
|||
Income tax benefit recognition on unrealized gain for available-for-sale securities
|
(205
|
)
|
|
—
|
|
|
(9,651
|
)
|
|||
Realized gain on sale of CASI stock (Note 8)
|
(2,674
|
)
|
|
—
|
|
|
—
|
|
|||
Unrealized loss (gain) on CASI stock holdings (Note 3(a) and Note 8)
|
12,665
|
|
|
(10,458
|
)
|
|
—
|
|
|||
Unrealized (gain) loss from transactions denominated in foreign currency
|
(6
|
)
|
|
10
|
|
|
(23
|
)
|
|||
Change in deferred taxes
|
(1,469
|
)
|
|
31
|
|
|
(5,237
|
)
|
|||
Change in fair value of contingent consideration
|
1,478
|
|
|
(1,927
|
)
|
|
4,957
|
|
|||
Accretion of debt discount on 2018 Convertible Notes, recorded to interest expense (Note 9)
|
—
|
|
|
1,931
|
|
|
4,890
|
|
|||
Amortization of deferred financing costs on 2018 Convertible Notes, recorded to interest expense (Note 9)
|
—
|
|
|
220
|
|
|
567
|
|
|||
Bad debt expense (recovery)
|
(12
|
)
|
|
12
|
|
|
(17
|
)
|
|||
Loss on 2018 Convertible Note purchase (Note 9)
|
—
|
|
|
—
|
|
|
845
|
|
|||
Change in cash surrender value of corporate-owned life insurance policy
|
—
|
|
|
(5
|
)
|
|
(418
|
)
|
|||
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
|||
Accounts receivable, net
|
29,420
|
|
|
2,844
|
|
|
7,694
|
|
|||
Other receivables
|
(5,871
|
)
|
|
(1,571
|
)
|
|
3,663
|
|
|||
Inventories
|
(2,037
|
)
|
|
3,390
|
|
|
4,318
|
|
|||
Prepaid expenses and other assets
|
(2,473
|
)
|
|
(3,642
|
)
|
|
(6,137
|
)
|
|||
Other assets
|
(1,188
|
)
|
|
5,010
|
|
|
1,573
|
|
|||
Accounts payable and other accrued liabilities
|
(35,769
|
)
|
|
12,112
|
|
|
6,459
|
|
|||
Accrued payroll and benefits
|
(2,168
|
)
|
|
592
|
|
|
280
|
|
|||
FOLOTYN development liability
|
(4
|
)
|
|
(389
|
)
|
|
(744
|
)
|
|||
Contract liabilities (Note 3(i))
|
(4,850
|
)
|
|
4,850
|
|
|
—
|
|
|||
Other long-term liabilities
|
3,047
|
|
|
(564
|
)
|
|
(3,389
|
)
|
|||
Deferred revenue
|
—
|
|
|
—
|
|
|
593
|
|
|||
Net cash used in operating activities
|
(134,631
|
)
|
|
(62,403
|
)
|
|
(38,855
|
)
|
|||
Cash Flows From Investing Activities:
|
|
|
|
|
|
||||||
Proceeds from Commercial Product Portfolio Transaction (Note 1(b))
|
158,571
|
|
|
—
|
|
|
—
|
|
|||
Proceeds from maturities of marketable securities
|
77,475
|
|
|
—
|
|
|
—
|
|
|||
Proceeds from sale of CASI stock (Note 8)
|
5,074
|
|
|
—
|
|
|
—
|
|
|||
Purchase of investment securities available-for-sale (Note 3(a))
|
(200,160
|
)
|
|
—
|
|
|
—
|
|
|||
Purchases of property and equipment (Note 3(b))
|
(9,018
|
)
|
|
(107
|
)
|
|
(465
|
)
|
|||
Proceeds from sale of property and equipment
|
50
|
|
|
—
|
|
|
—
|
|
|||
Proceeds from redemption of corporate-owned life insurance policy
|
—
|
|
|
4,130
|
|
|
—
|
|
|||
Cash paid for KHAPZORY distribution rights
|
—
|
|
|
(2,650
|
)
|
|
—
|
|
|||
Payment for corporate-owned life insurance premiums
|
—
|
|
|
—
|
|
|
(601
|
)
|
|||
Purchase of equity securities (Note 8)
|
—
|
|
|
—
|
|
|
(15
|
)
|
|||
Net cash provided by (used in) investing activities
|
31,992
|
|
|
1,373
|
|
|
(1,081
|
)
|
|||
Cash Flows From Financing Activities:
|
|
|
|
|
|
||||||
Proceeds from employees for exercises of stock options
|
7,147
|
|
|
13,475
|
|
|
5,477
|
|
|||
Proceeds from sale of stock under our employee stock purchase plan
|
663
|
|
|
1,122
|
|
|
1,010
|
|
|||
Proceeds from sale of common stock under an at-the-market sales agreement (Note 5)
|
1,817
|
|
|
—
|
|
|
128,272
|
|
|||
Proceeds from employees, for our remittance to tax authorities, upon vesting of restricted stock and upon exercises of stock options
|
—
|
|
|
4,645
|
|
|
—
|
|
|||
Payments to tax authorities upon employees' surrender of restricted stock upon vesting and upon exercises of stock options
|
—
|
|
|
(27,679
|
)
|
|
(4,331
|
)
|
|||
Payment of principal upon the maturity of the 2018 Convertible Notes (Note 9)
|
—
|
|
|
(20
|
)
|
|
—
|
|
|||
Purchase of 2018 Convertible Notes (Note 9)
|
—
|
|
|
—
|
|
|
(27,500
|
)
|
|||
Purchase of warrants related to the conversion hedge of 2018 Convertible Notes (Note 9)
|
—
|
|
|
—
|
|
|
(27,189
|
)
|
|||
Proceeds from sale of call options related to the conversion hedge of 2018 Convertible Notes (Note 9)
|
—
|
|
|
—
|
|
|
32,982
|
|
|||
Net cash provided by (used in) financing activities
|
9,627
|
|
|
(8,457
|
)
|
|
108,721
|
|
|||
Effect of exchange rates on cash and equivalents
|
(50
|
)
|
|
(356
|
)
|
|
316
|
|
|||
Net (decrease) increase in cash and cash equivalents
|
(93,062
|
)
|
|
(69,843
|
)
|
|
69,101
|
|
|||
Cash and cash equivalents — beginning of year
|
157,480
|
|
|
227,323
|
|
|
158,222
|
|
|||
Cash and cash equivalents — end of year
|
$
|
64,418
|
|
|
$
|
157,480
|
|
|
$
|
227,323
|
|
Supplemental Disclosure of Cash Flow Information:
|
|
|
|
|
|
||||||
Cash paid for facility and equipment under operating leases
|
$
|
1,835
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Cash paid for income taxes
|
$
|
38
|
|
|
$
|
45
|
|
|
$
|
17
|
|
Cash paid for interest
|
$
|
—
|
|
|
$
|
1,031
|
|
|
$
|
2,692
|
|
Noncash investing activities:
|
|
|
|
|
|
|
|
|
|||
Additions of property and equipment that remain in accounts payable and other accrued liabilities (Note 3(b))
|
$
|
2,760
|
|
|
$
|
—
|
|
|
$
|
—
|
|
•
|
ROLONTIS, a novel long-acting granulocyte colony-stimulating (“G-CSF”) for chemotherapy-induced neutropenia which has been filed with the FDA and has a Prescription Drug User Fee Act date of October 24, 2020;
|
•
|
Poziotinib, a novel irreversible tyrosine kinase inhibitor under investigation for non-small cell lung cancer tumors with various mutations; and
|
•
|
Anti-CD20-IFNá, an antibody-interferon fusion molecule directed against CD20 that is in Phase 1 development for treating relapsed or refractory non-Hodgkin’s lymphoma (“NHL”) patients (including diffuse large B-cell lymphoma).
|
(1)
|
we ensure that we have an executed contract(s) with our customer that we believe is legally enforceable;
|
(2)
|
we identify the “performance obligations” in the respective contract;
|
(3)
|
we determine the “transaction price” for each performance obligation in the respective contract;
|
(4)
|
we allocate the transaction price to each performance obligation; and
|
(5)
|
we recognize revenue only when we satisfy each performance obligation.
|
•
|
When our licensee is responsible for the achievement of the regulatory milestone, we recognize revenue in full (for the contractual amount due from our licensee) in the period that the approval occurs (i.e., when the “performance obligation” is satisfied by our customer) under the “most likely amount” method. This revenue recognition remains “constrained” (i.e., not recognized) until regulatory approval occurs, given its inherent uncertainty and the requirement of a significant revenue reversal not being probable if achievement does not occur. At each reporting period, we re-evaluate the probability of milestone achievement and the associated revenue constraint; any resulting adjustments would be recorded on a cumulative catch-up basis, thus reflected in our financial statements in the period of adjustment.
|
•
|
When we are responsible for the achievement of a regulatory milestone, the “relative selling price method” is applied for purposes of allocating the transaction price to our performance obligations. In such case, we consider (i) the extent of our effort to achieve the milestone and/or the enhancement of the value of the delivered item(s) as a result of milestone achievement and (ii) if the milestone payment is reasonable relative to all of the deliverables and payment terms (including other potential milestone consideration) within the arrangement. We have historically assessed the contractual value of these milestones upon their achievement to be identical to the allocation of value of our performance obligations and thus representing the “transaction price” for each milestone at contract inception. We recognize this revenue in the period that the regulatory approval occurs (i.e., when we complete the “performance obligation”) under the “most likely amount” method, and revenue recognition is otherwise “constrained” until regulatory approval occurs, given its inherent uncertainty and the requirement of a significant revenue reversal not being probable if achievement does not occur. At each reporting period, we re-evaluate the probability of milestone achievement and the associated revenue constraint; any resulting adjustments would be recorded on a cumulative catch-up basis, thus reflected in our financial statements in the period of adjustment.
|
|
Historical or Amortized Cost
|
|
Foreign Currency Translation
|
|
Unrealized
Gains |
|
Unrealized Losses
|
|
Fair Value
|
|
Cash and Cash
equivalents |
|
Marketable Securities
|
||||||||||||||
|
|||||||||||||||||||||||||||
December 31, 2019
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
Equity securities* (see Note 8)
|
$
|
6,310
|
|
|
$
|
(2,477
|
)
|
|
$
|
27,214
|
|
|
$
|
—
|
|
|
$
|
31,047
|
|
|
$
|
—
|
|
|
$
|
31,047
|
|
Money market funds
|
54,199
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
54,199
|
|
|
54,199
|
|
|
—
|
|
|||||||
Government-related debt securities**
|
62,617
|
|
|
—
|
|
|
19
|
|
|
(10
|
)
|
|
62,626
|
|
|
—
|
|
|
62,626
|
|
|||||||
Corporate debt securities**
|
58,235
|
|
|
—
|
|
|
38
|
|
|
(25
|
)
|
|
58,248
|
|
|
5,000
|
|
|
53,248
|
|
|||||||
Bank deposits
|
5,219
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
5,219
|
|
|
5,219
|
|
|
—
|
|
|||||||
Mutual funds
|
4,375
|
|
|
—
|
|
|
783
|
|
|
—
|
|
|
5,158
|
|
|
—
|
|
|
5,158
|
|
|||||||
Bank CDs
|
7,354
|
|
|
—
|
|
|
22
|
|
|
—
|
|
|
7,376
|
|
|
—
|
|
|
7,376
|
|
|||||||
Total cash and cash equivalents and marketable securities
|
$
|
198,309
|
|
|
$
|
(2,477
|
)
|
|
$
|
28,076
|
|
|
$
|
(35
|
)
|
|
$
|
223,873
|
|
|
$
|
64,418
|
|
|
$
|
159,455
|
|
December 31, 2018
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
Equity securities*
|
$
|
8,710
|
|
|
$
|
(2,168
|
)
|
|
$
|
39,880
|
|
|
$
|
—
|
|
|
$
|
46,422
|
|
|
$
|
—
|
|
|
$
|
46,422
|
|
Money market funds
|
142,745
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
142,745
|
|
|
142,745
|
|
|
—
|
|
|||||||
Bank deposits
|
14,735
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
14,735
|
|
|
14,735
|
|
|
—
|
|
|||||||
Bank CDs
|
86
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
86
|
|
|
—
|
|
|
86
|
|
|||||||
Total cash and cash equivalents and marketable securities
|
$
|
166,276
|
|
|
$
|
(2,168
|
)
|
|
$
|
39,880
|
|
|
$
|
—
|
|
|
$
|
203,988
|
|
|
$
|
157,480
|
|
|
$
|
46,508
|
|
|
December 31,
|
||||||
|
2019
|
|
2018
|
||||
Manufacturing equipment*
|
$
|
10,355
|
|
|
$
|
—
|
|
Computers hardware and software
|
3,606
|
|
|
3,079
|
|
||
Laboratory equipment
|
36
|
|
|
635
|
|
||
Office furniture
|
248
|
|
|
212
|
|
||
Leasehold improvements
|
3,374
|
|
|
2,957
|
|
||
Property and equipment, at cost
|
17,619
|
|
|
6,883
|
|
||
(Less): Accumulated depreciation
|
(6,012
|
)
|
|
(6,498
|
)
|
||
Property and equipment, net of accumulated depreciation
|
$
|
11,607
|
|
|
$
|
385
|
|
|
December 31,
|
||||||
|
2019
|
|
2018
|
||||
Vendor deposits
|
$
|
8,740
|
|
|
$
|
6,792
|
|
Prepaid insurance
|
1,408
|
|
|
782
|
|
||
Prepaid expenses and other assets
|
$
|
10,148
|
|
|
$
|
7,574
|
|
|
December 31,
|
||||||
|
2019
|
|
2018
|
||||
CASI other receivables
|
$
|
2,393
|
|
|
$
|
—
|
|
Other miscellaneous receivables (including Medicaid rebate credits and royalty receivables from licensees)
|
1,490
|
|
|
1,189
|
|
||
Insurance receivable*
|
4,015
|
|
|
206
|
|
||
Income tax receivable - current portion
|
973
|
|
|
643
|
|
||
Interest receivable from marketable securities (see Note 3(a))
|
561
|
|
|
—
|
|
||
Reimbursements due from development partners for incurred research and development expenses
|
126
|
|
|
135
|
|
||
Secured promissory note (see Note 8)
|
—
|
|
|
1,525
|
|
||
Other receivables
|
$
|
9,558
|
|
|
$
|
3,698
|
|
|
December 31,
|
||||||
|
2019
|
|
2018
|
||||
Key employee life insurance – cash surrender value (associated with our deferred compensation plan - see Note 7
|
$
|
3,547
|
|
|
$
|
6,274
|
|
Research & development supplies and other
|
119
|
|
|
246
|
|
||
Income tax receivable - non-current portion*
|
334
|
|
|
668
|
|
||
Other assets
|
$
|
4,000
|
|
|
$
|
7,188
|
|
|
December 31, 2019
|
|
December 31, 2018
|
||||
Office and research facilities
|
$
|
3,391
|
|
|
$
|
—
|
|
Office equipment
|
415
|
|
|
—
|
|
||
Facility and equipment under lease
|
$
|
3,806
|
|
|
$
|
—
|
|
|
December 31,
|
||||||
|
2019
|
|
2018
|
||||
Trade accounts payable and other
|
$
|
32,012
|
|
|
$
|
44,919
|
|
Lease liability - current portion
|
1,683
|
|
|
—
|
|
||
Accrued commercial/Medicaid rebates*
|
2,925
|
|
|
8,580
|
|
||
Accrued product royalty due to licensors
|
66
|
|
|
4,337
|
|
||
Allowance for product returns
|
4,714
|
|
|
5,171
|
|
||
Accrued data and distribution fees
|
768
|
|
|
3,248
|
|
||
Accrued GPO administrative fees
|
6
|
|
|
296
|
|
||
Accrued inventory management fees
|
364
|
|
|
388
|
|
||
Allowance for government chargebacks*
|
11,746
|
|
|
14,373
|
|
||
Accounts payable and other accrued liabilities
|
$
|
54,284
|
|
|
$
|
81,312
|
|
Description
|
Commercial/Medicaid Rebates and Government Chargebacks*
|
|
Distribution,
Data, Inventory, and GPO Administrative Fees |
|
Product Return Allowances
|
||||||
Balance as of December 31, 2017
|
$
|
21,480
|
|
|
$
|
5,727
|
|
|
$
|
4,045
|
|
Add: GTN accruals recorded for product sales
|
69,704
|
|
|
13,962
|
|
|
1,700
|
|
|||
(Less): Payments made and credits against GTN accruals
|
(68,232
|
)
|
|
(15,757
|
)
|
|
(574
|
)
|
|||
Balance as of December 31, 2018
|
22,952
|
|
|
3,932
|
|
|
5,171
|
|
|||
Add: GTN accruals recorded for product sales
|
7,702
|
|
|
1,209
|
|
|
167
|
|
|||
(Less): Payments made and credits against GTN accruals
|
(15,983
|
)
|
|
(4,003
|
)
|
|
(624
|
)
|
|||
Balance as of December 31, 2019
|
$
|
14,671
|
|
|
$
|
1,138
|
|
|
$
|
4,714
|
|
|
December 31,
|
||||||
|
2019
|
|
2018
|
||||
Customer deposit for EVOMELA supply in China territory (see Note 8)
|
$
|
—
|
|
|
$
|
4,850
|
|
Contract liabilities
|
$
|
—
|
|
|
$
|
4,850
|
|
|
December 31,
|
||||||
|
2019
|
|
2018
|
||||
Deferred compensation liability (Note 10(f))
|
$
|
8,597
|
|
|
$
|
5,474
|
|
Lease liability - non-current portion (Note 10(a))
|
2,372
|
|
|
—
|
|
||
Other tax liabilities
|
101
|
|
|
176
|
|
||
Other long-term liabilities
|
$
|
11,070
|
|
|
$
|
5,650
|
|
|
Year Ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
Selling, general and administrative
|
$
|
14,118
|
|
|
$
|
9,268
|
|
|
$
|
9,178
|
|
Research and development
|
4,316
|
|
|
2,566
|
|
|
1,885
|
|
|||
Total stock-based compensation
|
$
|
18,434
|
|
|
$
|
11,834
|
|
|
$
|
11,063
|
|
|
Year Ended December 31,
|
||||
|
2019
|
|
2018
|
|
2017
|
Expected option life (in years) (a)
|
5.34
|
|
4.73
|
|
4.84
|
Risk-free interest rate (b)
|
1.47% - 2.49%
|
|
1.81% - 2.75%
|
|
0.82% - 1.90%
|
Volatility (c)
|
61.6% - 76.1%
|
|
50.0% - 56.2%
|
|
49.3% - 61.4%
|
Dividend yield (d)
|
—%
|
|
—%
|
|
—%
|
Weighted-average grant-date fair value per stock option
|
$5.85
|
|
$8.64
|
|
$2.89
|
(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, 2016
|
14,340,582
|
|
|
$
|
6.86
|
|
|
|
|
|
|
|
|||
Granted
|
1,223,483
|
|
|
6.51
|
|
|
|
|
|
|
|
||||
Exercised
|
(937,482
|
)
|
|
6.40
|
|
|
|
|
$
|
6,813
|
|
|
(1
|
)
|
|
Forfeited
|
(244,793
|
)
|
|
6.26
|
|
|
|
|
|
|
|
||||
Expired
|
(524,577
|
)
|
|
6.27
|
|
|
|
|
|
|
|
||||
Outstanding — December 31, 2017
|
13,857,213
|
|
|
6.89
|
|
|
|
|
|
|
|
||||
Granted
|
1,094,358
|
|
|
18.87
|
|
|
|
|
|
|
|
||||
Exercised
|
(7,858,141
|
)
|
|
6.74
|
|
|
|
|
$
|
84,758
|
|
|
(1
|
)
|
|
Forfeited
|
(214,464
|
)
|
|
6.54
|
|
|
|
|
|
|
|
||||
Expired
|
(35,381
|
)
|
|
6.94
|
|
|
|
|
|
|
|
||||
Outstanding — December 31, 2018
|
6,843,585
|
|
|
8.98
|
|
|
|
|
|
|
|
|
|||
Granted
|
1,113,081
|
|
|
10.54
|
|
|
|
|
|
|
|
||||
Exercised
|
(1,121,403
|
)
|
|
6.38
|
|
|
|
|
$
|
2,919
|
|
|
(1
|
)
|
|
Forfeited
|
(172,074
|
)
|
|
9.84
|
|
|
|
|
|
|
|
||||
Expired
|
(223,253
|
)
|
|
11.09
|
|
|
|
|
|
|
|
||||
Outstanding — December 31, 2019
|
6,439,936
|
|
|
$
|
9.61
|
|
|
6.16
|
|
$
|
1
|
|
|
(2
|
)
|
Vested (exercisable) — December 31, 2019
|
4,682,766
|
|
|
$
|
8.66
|
|
|
5.29
|
|
$
|
1
|
|
|
(2
|
)
|
Unvested (unexercisable) — December 31, 2019
|
1,757,170
|
|
|
$
|
12.14
|
|
|
8.47
|
|
$
|
—
|
|
|
(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 2019 and the stock option exercise price, multiplied by the number of in-the-money options as of December 31, 2019. 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 |
||||||
$1.47 - 4.96
|
91,599
|
|
|
2.80
|
|
$
|
4.16
|
|
|
82,428
|
|
|
$
|
4.15
|
|
$4.97 - 6.91
|
2,210,050
|
|
|
6.18
|
|
6.00
|
|
|
1,866,277
|
|
|
5.97
|
|
||
$6.92 - 9.00
|
1,801,136
|
|
|
4.91
|
|
7.84
|
|
|
1,565,804
|
|
|
7.76
|
|
||
$9.01 - 12.00
|
1,135,793
|
|
|
7.23
|
|
11.03
|
|
|
509,250
|
|
|
10.70
|
|
||
$12.01 - 22.64
|
1,201,358
|
|
|
7.24
|
|
17.97
|
|
|
659,007
|
|
|
17.39
|
|
||
|
6,439,936
|
|
|
6.16
|
|
$
|
9.61
|
|
|
4,682,766
|
|
|
$
|
8.66
|
|
|
Number of
Restricted Stock Awards |
|
Weighted Average
Fair Value per Share at Grant Date |
|||
Unvested — December 31, 2016
|
2,152,157
|
|
|
$
|
6.29
|
|
Granted
|
927,306
|
|
|
6.22
|
|
|
Vested
|
(1,137,555
|
)
|
|
6.38
|
|
|
Forfeited
|
(378,990
|
)
|
|
5.95
|
|
|
Unvested — December 31, 2017
|
1,562,918
|
|
|
6.27
|
|
|
Granted
|
1,092,534
|
|
|
17.35
|
|
|
Vested
|
(635,320
|
)
|
|
6.51
|
|
|
Forfeited
|
(218,002
|
)
|
|
7.56
|
|
|
Unvested — December 31, 2018
|
1,802,130
|
|
|
12.75
|
|
|
Granted
|
1,091,353
|
|
|
10.50
|
|
|
Vested
|
(972,404
|
)
|
|
11.70
|
|
|
Forfeited
|
(261,320
|
)
|
|
11.48
|
|
|
Unvested — December 31, 2019
|
1,659,759
|
|
|
$
|
11.67
|
|
|
Year Ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
Restricted stock award expense
|
$
|
9,170
|
|
|
$
|
5,180
|
|
|
$
|
4,985
|
|
|
Number of
Restricted Stock Units |
|
Weighted Average
Fair Value per Share at Grant Date |
|||
Outstanding — December 31, 2017
|
217,206
|
|
|
$
|
6.49
|
|
Granted
|
138,334
|
|
|
28.31
|
|
|
Market-based achievement adjustment at vesting
|
100,326
|
|
|
6.49
|
|
|
Share issuance upon approved achievement date
|
(200,652
|
)
|
|
6.49
|
|
|
Outstanding — December 31, 2018
|
255,214
|
|
|
17.91
|
|
|
Granted
|
257,585
|
|
|
12.87
|
|
|
Market-based achievement adjustment at vesting
|
116,880
|
|
|
6.49
|
|
|
Share issuance
|
(243,760
|
)
|
|
7.04
|
|
|
Outstanding — December 31, 2019
|
385,919
|
|
|
$
|
18.00
|
|
|
2019
|
|
2018
|
|
2017
|
||||||
Restricted stock unit expense
|
$
|
3,019
|
|
|
$
|
2,301
|
|
|
$
|
1,030
|
|
|
Year Ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
Shares of common stock issued
|
225,780
|
|
|
70,379
|
|
|
102,874
|
|
|||
Value of employer match in shares
|
$
|
1,289
|
|
|
$
|
762
|
|
|
$
|
639
|
|
|
Number of
Shares |
|
Weighted
Average Exercise Price |
|||
Outstanding — December 31, 2016
|
445,000
|
|
|
$
|
6.78
|
|
Outstanding — December 31, 2017
|
445,000
|
|
|
6.78
|
|
|
Exercised
|
(445,000
|
)
|
|
6.78
|
|
|
Outstanding — December 31, 2018
|
—
|
|
|
$
|
—
|
|
Description of Financing Transaction
|
|
No. of Common Shares Issued
|
|
Proceeds Received (Net of Broker Commissions and Fees )
|
|||
Common shares issued pursuant to the December 2015 ATM Agreement between July 1, 2017 and July 31, 2017
|
|
3,243,882
|
|
|
$
|
23,745
|
|
Common shares issued pursuant to the August 2017 ATM Agreement between August 1, 2017 and December 31, 2017
|
|
10,314,250
|
|
|
$
|
104,527
|
|
Common shares issued pursuant to the April 2019 ATM Agreement during the year ended December 31, 2019
|
|
221,529
|
|
|
$
|
1,814
|
|
|
Year Ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
Net loss
|
$
|
(112,689
|
)
|
|
$
|
(120,741
|
)
|
|
$
|
(92,189
|
)
|
Weighted average shares—basic and diluted
|
110,585,768
|
|
|
103,305,911
|
|
|
85,115,592
|
|
|||
Net loss per share—basic and diluted
|
$
|
(1.02
|
)
|
|
$
|
(1.17
|
)
|
|
$
|
(1.08
|
)
|
|
Year Ended December 31,
|
|||||||
|
2019
|
|
2018
|
|
2017
|
|||
Common stock options issued
|
1,059,846
|
|
|
4,407,765
|
|
|
3,668,662
|
|
Restricted stock awards issued
|
1,659,759
|
|
|
1,802,130
|
|
|
1,562,918
|
|
Restricted stock units issued
|
385,919
|
|
|
255,214
|
|
|
217,206
|
|
2013 Convertible Notes outstanding - if converted into common shares
|
—
|
|
|
—
|
|
|
3,854,959
|
|
Common stock warrants issued
|
—
|
|
|
—
|
|
|
138,277
|
|
Total
|
3,105,524
|
|
|
6,465,109
|
|
|
9,442,022
|
|
|
December 31, 2019
Fair Value Measurements |
|
||||||||||||||
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
|
||||||||
Assets:
|
|
|
|
|
|
|
|
|
||||||||
Equity securities (Note 8)
|
$
|
31,047
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
31,047
|
|
|
Bank CDs
|
—
|
|
|
7,376
|
|
|
—
|
|
|
7,376
|
|
|
||||
Mutual funds
|
5,158
|
|
|
11
|
|
|
—
|
|
|
5,169
|
|
|
||||
Key employee life insurance, cash surrender value - Note 3(f))
|
—
|
|
|
3,547
|
|
|
—
|
|
|
3,547
|
|
*
|
||||
Money market funds
|
54,199
|
|
|
—
|
|
|
—
|
|
|
54,199
|
|
|
||||
Government-related debt securities
|
47,636
|
|
|
14,990
|
|
|
—
|
|
|
62,626
|
|
|
||||
Corporate debt securities
|
—
|
|
|
58,248
|
|
|
—
|
|
|
58,248
|
|
|
||||
|
$
|
138,040
|
|
|
$
|
84,172
|
|
|
$
|
—
|
|
|
$
|
222,212
|
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
||||||||
Deferred executive compensation liability (Note 10(f))
|
$
|
—
|
|
|
$
|
8,746
|
|
|
$
|
—
|
|
|
$
|
8,746
|
|
*
|
|
$
|
—
|
|
|
$
|
8,746
|
|
|
$
|
—
|
|
|
$
|
8,746
|
|
|
|
December 31, 2018
Fair Value Measurements |
|
||||||||||||||
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
|
||||||||
Assets:
|
|
|
|
|
|
|
|
|
||||||||
Equity securities (Note 8)
|
$
|
46,422
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
46,422
|
|
|
Bank CDs
|
—
|
|
|
86
|
|
|
—
|
|
|
86
|
|
|
||||
Mutual funds
|
—
|
|
|
78
|
|
|
—
|
|
|
78
|
|
|
||||
Key employee life insurance, cash surrender value
|
—
|
|
|
6,274
|
|
|
—
|
|
|
6,274
|
|
*
|
||||
Money market funds
|
—
|
|
|
142,745
|
|
|
—
|
|
|
142,745
|
|
|
||||
|
$
|
46,422
|
|
|
$
|
149,183
|
|
|
$
|
—
|
|
|
$
|
195,605
|
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
||||||||
Deferred executive compensation liability (Note 10(f))
|
$
|
—
|
|
|
$
|
6,167
|
|
|
$
|
—
|
|
|
$
|
6,167
|
|
*
|
|
$
|
—
|
|
|
$
|
6,167
|
|
|
$
|
—
|
|
|
$
|
6,167
|
|
|
|
|
December 31,
|
||||||
|
|
2018
|
|
2017
|
||||
Stated coupon interest expense
|
|
$
|
981
|
|
|
$
|
2,615
|
|
Amortization of debt issuance costs
|
|
220
|
|
|
567
|
|
||
Accretion of debt discount
|
|
1,931
|
|
|
4,890
|
|
||
Total interest expense
|
|
$
|
3,132
|
|
|
$
|
8,072
|
|
Effective interest rate
|
|
8.41
|
%
|
|
8.41
|
%
|
Operating Leases*
|
|
Consolidated Balance Sheet Caption
|
|
December 31, 2019
|
||
Operating lease right-of-use assets - non-current
|
|
Facility and equipment under lease
|
|
$
|
3,806
|
|
|
|
|
|
|
||
Operating lease liabilities - current
|
|
Accounts payable and other accrued liabilities
|
|
$
|
1,683
|
|
Operating lease liabilities - non-current
|
|
Other long-term liabilities
|
|
2,372
|
|
|
Total lease liabilities
|
|
|
|
$
|
4,055
|
|
|
|
Weighted Average Remaining Lease Term
|
|
Weighted Average Discount Rate
|
Operating leases as of December 31, 2019
|
|
2.5 years
|
|
7.8%
|
Operating Leases - future payments
|
|
December 31, 2019
|
||
2020
|
|
$
|
1,934
|
|
2021
|
|
1,671
|
|
|
2022
|
|
828
|
|
|
2023
|
|
87
|
|
|
2024
|
|
—
|
|
|
Total future lease payments, undiscounted
|
|
$
|
4,520
|
|
(Less): Implied interest
|
|
(465
|
)
|
|
Present value of operating lease payments
|
|
$
|
4,055
|
|
Operating Leases - future payments
|
|
December 31, 2018
|
||
2019
|
|
$
|
1,486
|
|
2020
|
|
1,441
|
|
|
2021
|
|
1,465
|
|
|
2022
|
|
828
|
|
|
2023 and thereafter
|
|
87
|
|
|
|
|
$
|
5,308
|
|
|
Year Ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
United States
|
$
|
(139,682
|
)
|
|
$
|
(133,165
|
)
|
|
$
|
(121,507
|
)
|
Foreign
|
(4,912
|
)
|
|
4,558
|
|
|
(1,185
|
)
|
|||
Total
|
$
|
(144,594
|
)
|
|
$
|
(128,607
|
)
|
|
$
|
(122,692
|
)
|
|
Year Ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
Current:
|
|
|
|
|
|
||||||
Federal
|
$
|
(6,584
|
)
|
|
$
|
(1,663
|
)
|
|
$
|
(15,412
|
)
|
State
|
(1,166
|
)
|
|
(269
|
)
|
|
(1,298
|
)
|
|||
Foreign
|
11
|
|
|
—
|
|
|
6
|
|
|||
|
$
|
(7,739
|
)
|
|
$
|
(1,932
|
)
|
|
$
|
(16,704
|
)
|
Deferred:
|
|
|
|
|
|
||||||
Federal
|
(781
|
)
|
|
12
|
|
|
(5,256
|
)
|
|||
State
|
(688
|
)
|
|
19
|
|
|
19
|
|
|||
|
(1,469
|
)
|
|
31
|
|
|
(5,237
|
)
|
|||
Total income tax benefit
|
$
|
(9,208
|
)
|
|
$
|
(1,901
|
)
|
|
$
|
(21,941
|
)
|
|
Year Ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
Tax provision computed at the federal statutory rate
|
$
|
(30,365
|
)
|
|
$
|
(26,854
|
)
|
|
$
|
(42,614
|
)
|
State tax, net of federal benefit
|
(4,126
|
)
|
|
(5,077
|
)
|
|
(2,207
|
)
|
|||
Research and development expense tax credits
|
(2,526
|
)
|
|
(4,884
|
)
|
|
(1,176
|
)
|
|||
Change in uncertain tax benefit reserve
|
—
|
|
|
—
|
|
|
(561
|
)
|
|||
Change in tax credit carryforwards
|
81
|
|
|
(3,056
|
)
|
|
386
|
|
|||
Officers compensation
|
1,506
|
|
|
600
|
|
|
(9,292
|
)
|
|||
Stock based compensation
|
(230
|
)
|
|
(12,610
|
)
|
|
(2,734
|
)
|
|||
Permanent items and other
|
267
|
|
|
(116
|
)
|
|
1,450
|
|
|||
Tax differential on foreign earnings
|
(31
|
)
|
|
(32
|
)
|
|
33
|
|
|||
Change in tax rate
|
1,126
|
|
|
(1,329
|
)
|
|
37,768
|
|
|||
Refundable alternative minimum tax credit
|
—
|
|
|
—
|
|
|
(1,336
|
)
|
|||
Change in prior year deferred taxes
|
1,170
|
|
|
6,595
|
|
|
(1,218
|
)
|
|||
Valuation allowance
|
23,920
|
|
|
44,862
|
|
|
(440
|
)
|
|||
Income tax benefit
|
$
|
(9,208
|
)
|
|
$
|
(1,901
|
)
|
|
$
|
(21,941
|
)
|
|
December 31,
|
||||||
|
2019
|
|
2018
|
||||
Deferred tax assets:
|
|
|
|
||||
Net operating loss carry forwards
|
$
|
118,163
|
|
|
$
|
103,582
|
|
Research and development expense tax credits
|
22,724
|
|
|
21,618
|
|
||
Stock based compensation
|
4,385
|
|
|
5,057
|
|
||
Lease obligation
|
919
|
|
|
—
|
|
||
Development costs
|
704
|
|
|
3,938
|
|
||
Returns and allowances
|
1,069
|
|
|
1,976
|
|
||
Other, net
|
11,861
|
|
|
7,185
|
|
||
Total deferred tax assets before valuation allowance
|
159,825
|
|
|
143,356
|
|
||
Valuation allowance
|
(152,966
|
)
|
|
(131,042
|
)
|
||
Total deferred tax assets
|
6,859
|
|
|
12,314
|
|
||
Deferred tax liabilities, net:
|
|
|
|
||||
Unrealized gains
|
(5,607
|
)
|
|
(9,387
|
)
|
||
Depreciation and amortization differences
|
(389
|
)
|
|
(4,396
|
)
|
||
Right-of-use asset
|
(863
|
)
|
|
—
|
|
||
Net deferred tax liabilities
|
$
|
—
|
|
|
$
|
(1,469
|
)
|
|
Year Ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
Balance at beginning of year
|
$
|
3,248
|
|
|
$
|
2,715
|
|
|
$
|
3,271
|
|
Adjustments related to prior year tax positions
|
(392
|
)
|
|
(551
|
)
|
|
(39
|
)
|
|||
Increases related to current year tax positions
|
692
|
|
|
1,084
|
|
|
374
|
|
|||
Decreases due to expiration of tax statutes
|
(75
|
)
|
|
—
|
|
|
(891
|
)
|
|||
Balance at end of year
|
$
|
3,473
|
|
|
$
|
3,248
|
|
|
$
|
2,715
|
|
|
|
Year ended December 31,
|
||||||||||
|
|
2019
|
|
2018
|
|
2017
|
||||||
Revenues:
|
|
|
|
|
|
|
||||||
Product sales, net*
|
|
$
|
22,325
|
|
|
$
|
103,736
|
|
|
$
|
115,237
|
|
License fees and service revenue
|
|
290
|
|
|
4,867
|
|
|
12,189
|
|
|||
Total revenues
|
|
$
|
22,615
|
|
|
$
|
108,603
|
|
|
$
|
127,426
|
|
Operating costs and expenses:
|
|
|
|
|
|
|
||||||
Cost of sales (excluding amortization of intangible assets)
|
|
12,007
|
|
|
26,756
|
|
|
42,859
|
|
|||
Cost of service revenue
|
|
—
|
|
|
—
|
|
|
4,359
|
|
|||
Selling, general and administrative
|
|
5,801
|
|
|
28,010
|
|
|
19,508
|
|
|||
Research and development
|
|
2,624
|
|
|
19,799
|
|
|
14,370
|
|
|||
Amortization of intangible assets
|
|
1,248
|
|
|
28,098
|
|
|
27,647
|
|
|||
Restructuring charges - employee severance (Note 13)
|
|
3,858
|
|
|
—
|
|
|
—
|
|
|||
Total operating costs and expenses
|
|
$
|
25,538
|
|
|
$
|
102,663
|
|
|
$
|
108,743
|
|
Income (loss) from discontinued operations
|
|
$
|
(2,923
|
)
|
|
$
|
5,940
|
|
|
$
|
18,683
|
|
Other income (expense):
|
|
|
|
|
|
|
||||||
Change in fair value of contingent consideration
|
|
(1,478
|
)
|
|
1,927
|
|
|
(4,957
|
)
|
|||
Gain on sale of Commercial Product Portfolio**
|
|
34,568
|
|
|
—
|
|
|
—
|
|
|||
Total other income (expense)
|
|
$
|
33,090
|
|
|
$
|
1,927
|
|
|
$
|
(4,957
|
)
|
Income from discontinued operations before income taxes
|
|
30,167
|
|
|
7,867
|
|
|
13,726
|
|
|||
Provision for income taxes from discontinued operations***
|
|
(7,470
|
)
|
|
(1,902
|
)
|
|
(5,163
|
)
|
|||
Income from discontinued operations, net of income taxes
|
|
$
|
22,697
|
|
|
$
|
5,965
|
|
|
$
|
8,563
|
|
|
|
December 31, 2018
|
||
Inventories
|
|
$
|
3,550
|
|
Prepaid expenses and other assets
|
|
2,005
|
|
|
Discontinued operations, current assets
|
|
5,555
|
|
|
|
|
|
||
Intangible assets, net of accumulated amortization
|
|
111,594
|
|
|
Goodwill
|
|
18,061
|
|
|
Other assets
|
|
2,970
|
|
|
Discontinued operations, non-current assets
|
|
132,625
|
|
|
|
|
|
||
FOLOTYN development liability
|
|
2,311
|
|
|
Discontinued operations, current liabilities
|
|
2,311
|
|
|
|
|
|
||
FOLOTYN development liability, less current portion
|
|
9,686
|
|
|
Acquisition-related contingent obligations
|
|
4,345
|
|
|
Discontinued operations, non-current liabilities
|
|
$
|
14,031
|
|
|
|
Year ended December 31,
|
||||||||||
|
|
2019
|
|
2018
|
|
2017
|
||||||
Depreciation and amortization
|
|
$
|
1,263
|
|
|
$
|
28,187
|
|
|
$
|
27,661
|
|
Stock-based compensation
|
|
$
|
3,404
|
|
|
$
|
5,649
|
|
|
$
|
4,076
|
|
Change in fair value of contingent consideration
|
|
$
|
1,478
|
|
|
$
|
(1,927
|
)
|
|
$
|
4,957
|
|
|
Quarter Ended (Unaudited)
|
||||||||||||||
|
March 31,
|
|
June 30,
|
|
September 30,
|
|
December 31,
|
||||||||
2019
|
|
|
|
|
|
|
|
||||||||
Total revenues
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Loss from continuing operations before other income (expense) and income taxes
|
$
|
(37,838
|
)
|
|
$
|
(34,212
|
)
|
|
$
|
(30,293
|
)
|
|
$
|
(38,355
|
)
|
Loss from continuing operations*
|
$
|
(39,846
|
)
|
|
$
|
(28,783
|
)
|
|
$
|
(26,557
|
)
|
|
$
|
(40,200
|
)
|
Basic and diluted loss per common share from continuing operations***
|
$
|
(0.36
|
)
|
|
$
|
(0.26
|
)
|
|
$
|
(0.24
|
)
|
|
$
|
(0.36
|
)
|
|
Quarter Ended (Unaudited)
|
||||||||||||||
|
March 31,
|
|
June 30,
|
|
September 30,
|
|
December 31,
|
||||||||
2018
|
|
|
|
|
|
|
|
||||||||
Total revenues
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Loss from continuing operations before other income (expense) and income taxes
|
$
|
(29,981
|
)
|
|
$
|
(32,986
|
)
|
|
$
|
(28,422
|
)
|
|
$
|
(46,458
|
)
|
(Loss) income from continuing operations**
|
$
|
(19,243
|
)
|
|
$
|
14,863
|
|
|
$
|
(69,209
|
)
|
|
$
|
(53,117
|
)
|
Basic and diluted (loss) income per common share from continuing operations***
|
$
|
(0.19
|
)
|
|
$
|
0.14
|
|
|
$
|
(0.66
|
)
|
|
$
|
(0.52
|
)
|
|
|
As Previously Reported
|
|
Adjustments for Error Correction
|
|
As Restated
|
||||||
Accounts payable and other accrued liabilities
|
|
$
|
69,460
|
|
|
$
|
11,852
|
|
|
$
|
81,312
|
|
Total current liabilities
|
|
86,474
|
|
|
11,852
|
|
|
98,326
|
|
|||
Total liabilities
|
|
107,624
|
|
|
11,852
|
|
|
119,476
|
|
|||
Accumulated deficit
|
|
(599,886
|
)
|
|
(11,852
|
)
|
|
(611,738
|
)
|
|||
Total stockholders’ equity
|
|
283,262
|
|
|
(11,852
|
)
|
|
271,410
|
|
|
|
2018
|
||||||||||||||
|
|
As Previously Reported
|
|
Adjustments for Error Correction
|
|
Reclassification for Discontinued Operations
|
|
As Restated
|
||||||||
Product sales, net
|
|
$
|
104,466
|
|
|
$
|
(730
|
)
|
|
$
|
(103,736
|
)
|
|
$
|
—
|
|
Total revenues
|
|
109,333
|
|
|
(730
|
)
|
|
(108,603
|
)
|
|
—
|
|
||||
Loss from continuing operations before other (expense) income and income taxes
|
|
(131,177
|
)
|
|
(730
|
)
|
|
(5,940
|
)
|
|
(137,847
|
)
|
||||
Loss from continuing operations before income taxes
|
|
(120,010
|
)
|
|
(730
|
)
|
|
(7,867
|
)
|
|
(128,607
|
)
|
||||
Benefit for income taxes from continuing operations
|
|
(1
|
)
|
|
—
|
|
|
1,902
|
|
|
1,901
|
|
||||
Loss from continuing operations
|
|
(120,011
|
)
|
|
(730
|
)
|
|
(5,965
|
)
|
|
(126,706
|
)
|
||||
Loss per common share from continuing operations
|
|
(1.16
|
)
|
|
(0.01
|
)
|
|
(0.06
|
)
|
|
(1.23
|
)
|
|
|
2017
|
||||||||||||||
|
|
As Previously Reported
|
|
Adjustments for Error Correction
|
|
Reclassification for Discontinued Operations
|
|
As Restated
|
||||||||
Product sales, net
|
|
$
|
116,178
|
|
|
$
|
(941
|
)
|
|
$
|
(115,237
|
)
|
|
$
|
—
|
|
Total revenues
|
|
128,367
|
|
|
(941
|
)
|
|
(127,426
|
)
|
|
—
|
|
||||
Loss from continuing operations before other (expense) income and income taxes
|
|
(96,660
|
)
|
|
(941
|
)
|
|
(18,683
|
)
|
|
(116,284
|
)
|
||||
Loss from continuing operations before income taxes
|
|
(108,026
|
)
|
|
(941
|
)
|
|
(13,726
|
)
|
|
(122,693
|
)
|
||||
Benefit for income taxes from continuing operations
|
|
16,778
|
|
|
—
|
|
|
5,163
|
|
|
21,941
|
|
||||
Loss from continuing operations
|
|
(91,248
|
)
|
|
(941
|
)
|
|
(8,563
|
)
|
|
(100,752
|
)
|
||||
Loss per common share from continuing operations
|
|
(1.07
|
)
|
|
(0.01
|
)
|
|
(0.10
|
)
|
|
(1.18
|
)
|
|
|
2018
|
||||||||||
|
|
As Previously Reported
|
|
Adjustments for Error Correction
|
|
As Restated
|
||||||
Net loss
|
|
$
|
(120,011
|
)
|
|
$
|
(730
|
)
|
|
$
|
(120,741
|
)
|
Total comprehensive loss
|
|
(122,501
|
)
|
|
(730
|
)
|
|
(123,231
|
)
|
|
|
2017
|
||||||||||
|
|
As Previously Reported
|
|
Adjustments for Error Correction
|
|
As Restated
|
||||||
Net loss
|
|
$
|
(91,248
|
)
|
|
$
|
(941
|
)
|
|
$
|
(92,189
|
)
|
Total comprehensive loss
|
|
(73,670
|
)
|
|
(941
|
)
|
|
(74,611
|
)
|
(a)
|
Financial Statements and Schedules
|
|
|
|
Additions
(Reductions) |
|
|
|
|
||||||||||||
|
|
|
($ in thousands)
|
|
|
|
|
||||||||||||
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, 2019
|
|
|
|
|
|
|
|
|
|
||||||||||
Allowance for doubtful accounts
|
$
|
67
|
|
|
$
|
(12
|
)
|
|
$
|
43
|
|
|
$
|
(55
|
)
|
|
$
|
43
|
|
December 31, 2018
|
|
|
|
|
|
|
|
|
|
||||||||||
Allowance for doubtful accounts
|
$
|
71
|
|
|
$
|
12
|
|
|
$
|
—
|
|
|
$
|
(16
|
)
|
|
$
|
67
|
|
December 31, 2017
|
|
|
|
|
|
|
|
|
|
||||||||||
Allowance for doubtful accounts
|
$
|
88
|
|
|
$
|
(17
|
)
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
71
|
|
(1)
|
Deductions represent the actual write-off of accounts receivable balances.
|
Exhibit No.
|
Description
|
Form
|
File No.
|
Exhibit
|
Filing Date
|
Filed Herewith
|
|
|
|
|
|
|
|
2.1
|
8-K
|
001-35006
|
2.1, 2.2, and 2.3
|
4/5/12
|
|
|
|
|
|
|
|
|
|
2.2
|
8-K
|
001-35006
|
2.1
|
7/19/13
|
|
|
|
|
|
|
|
|
|
2.3
|
8-K
|
001-35006
|
2.2
|
7/19/13
|
|
|
|
|
|
|
|
|
|
2.4
|
8-K
|
001-35006
|
2.4
|
7/19/13
|
|
|
|
|
|
|
|
|
|
2.5
|
8-K
|
001-35006
|
10.1
|
1/17/19
|
|
|
|
|
|
|
|
|
|
3.1
|
8-K
|
001-35006
|
3.1
|
6/18/18
|
|
|
|
|
|
|
|
|
|
3.2
|
8-K
|
001-35006
|
3.1
|
3/29/18
|
|
|
|
|
|
|
|
|
|
4.1
|
8-K
|
000-28782
|
4.1
|
12/13/10
|
|
|
|
|
|
|
|
|
|
4.2
|
8-K
|
001-35006
|
4.1
|
10/13/17
|
|
|
|
|
|
|
|
|
|
4.3
|
8-K
|
001-35006
|
4.1
|
3/29/18
|
|
|
|
|
|
|
|
|
|
4.4
|
10-K
|
001-35006
|
4.2
|
3/12/14
|
|
|
|
|
|
|
|
|
|
4.5
|
|
|
|
|
X
|
|
|
|
|
|
|
|
|
10.1
|
10-KSB
|
000-28782
|
10.11
|
3/31/97
|
|
|
|
|
|
|
|
|
|
10.2
|
10-Q
|
000-28782
|
10.1
|
5/17/04
|
|
|
|
|
|
|
|
|
|
10.3
|
10-K
|
001-35006
|
10.6
|
3/12/14
|
|
|
|
|
|
|
|
|
|
10.4
|
10-K
|
001-35006
|
10.7
|
3/12/14
|
|
|
|
|
|
|
|
|
|
10.5
|
10-K
|
000-28782
|
10.29
|
4/5/10
|
|
|
|
|
|
|
|
|
|
10.6
|
10-K
|
001-35006
|
10.9
|
3/12/14
|
|
|
|
|
|
|
|
|
|
10.7
|
10-K
|
001-35006
|
10.10
|
3/12/14
|
|
|
|
|
|
|
|
|
|
10.8
|
|
|
|
|
X
|
|
|
|
|
|
|
|
|
10.9
|
|
|
|
|
X
|
|
|
|
|
|
|
|
|
10.10*
|
S-8
|
333-176681
|
4.1
|
9/6/11
|
|
|
|
|
|
|
|
|
|
10.11*
|
|
|
|
|
X
|
|
|
|
|
|
|
|
|
10.12*
|
|
|
|
|
X
|
|
|
|
|
|
|
|
|
10.13*
|
S-8
|
333-160312
|
99.2
|
6/29/09
|
|
|
|
|
|
|
|
|
|
10.14*
|
10-Q
|
000-28782
|
10.8
|
8/13/09
|
|
|
|
|
|
|
|
|
|
10.15*
|
10-Q
|
001-35006
|
10.2
|
11/9/12
|
|
|
|
|
|
|
|
|
|
10.16*
|
10-Q
|
000-28782
|
10.10
|
8/13/09
|
|
|
|
|
|
|
|
|
|
10.17*
|
10-Q
|
001-35006
|
10.2
|
11/6/15
|
|
|
|
|
|
|
|
|
|
10.18*
|
10-Q
|
001-35006
|
10.2
|
5/4/17
|
|
|
|
|
|
|
|
|
|
10.19
|
S-3
|
333-208760
|
1.2
|
12/23/15
|
|
|
|
|
|
|
|
|
|
10.20
|
8-K
|
001-35006
|
1.1
|
8/4/17
|
|
|
|
|
|
|
|
|
|
10.21
|
S-3ASR
|
333-230821
|
1.2
|
4/5/19
|
|
|
|
|
|
|
|
|
|
10.22*
|
10-Q
|
001-35006
|
10.6
|
8/9/18
|
|
|
|
|
|
|
|
|
|
10.23*
|
10-Q
|
001-35006
|
10.7
|
8/9/18
|
|
|
|
|
|
|
|
|
|
10.24*
|
10-Q
|
001-35006
|
10.8
|
8/9/18
|
|
|
|
|
|
|
|
|
|
10.25*
|
10-Q
|
001-35006
|
10.9
|
8/9/18
|
|
|
|
|
|
|
|
|
|
10.26*
|
10-Q
|
001-35006
|
10.1
|
8/9/19
|
|
|
|
|
|
|
|
|
|
10.27*
|
8-K
|
001-35006
|
10.1
|
6/18/18
|
|
|
|
|
|
|
|
|
|
10.28*
|
8-K
|
001-35006
|
10.2
|
6/18/18
|
|
|
|
|
|
|
|
|
|
10.29*
|
8-K
|
001-35006
|
10.3
|
6/18/18
|
|
|
|
|
|
|
|
|
|
10.30*
|
8-K
|
001-35006
|
10.4
|
6/18/18
|
|
|
|
|
|
|
|
|
|
10.31*
|
8-K
|
001-35006
|
10.5
|
6/18/18
|
|
|
|
|
|
|
|
|
|
21.1
|
|
|
|
|
X
|
|
|
|
|
|
|
|
|
23.1
|
|
|
|
|
X
|
|
|
|
|
|
|
|
|
24.1
|
|
|
|
|
X
|
|
|
|
|
|
|
|
|
31.1
|
|
|
|
|
X
|
|
|
|
|
|
|
|
|
31.2
|
|
|
|
|
X
|
|
|
|
|
|
|
|
|
32.1
|
|
|
|
|
X
|
|
|
|
|
|
|
|
|
32.2
|
|
|
|
|
X
|
|
|
|
|
|
|
|
|
101.INS
|
Inline XBRL Instance Document - the Instance Document does not appear in the interactive data file because its XBRL tags are embedded within the Inline XBRL Document
|
|
|
|
|
X
|
|
|
|
|
|
|
|
101.SCH
|
Inline XBRL Taxonomy Extension Schema Document
|
|
|
|
|
X
|
|
|
|
|
|
|
|
101.CAL
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Inline XBRL Taxonomy Extension Calculation Linkbase Document
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X
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101.DEF
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Inline XBRL Taxonomy Extension Definition Linkbase Document
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X
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101.LAB
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Inline XBRL Taxonomy Extension Label Linkbase Document
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X
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101.PRE
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Inline XBRL Taxonomy Extension Presentation Linkbase Document
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X
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104
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Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101 filed herewith)
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the title of the shares of preferred stock;
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the number of shares of preferred stock offered, the liquidation preference per share and the offering price of the shares of preferred stock;
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the dividend rate(s), period(s) and/or payment date(s) or method(s) of calculation thereof applicable to the shares of preferred stock;
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whether the shares of preferred stock are cumulative or not and, if cumulative, the date from which dividends on the shares of preferred stock shall accumulate;
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the procedures for any auction and remarketing, if any, for the shares of preferred stock;
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the provision for a sinking fund, if any, for the shares of preferred stock;
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the provision for redemption or repurchase, if applicable, and any restrictions on our ability to exercise those redemption and repurchase rights of the shares of preferred stock;
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any listing of the shares of preferred stock on any securities exchange;
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the terms and conditions, if applicable, upon which the shares of preferred stock will be convertible into common shares, including the conversion price (or manner of calculation thereof);
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discussion of federal income tax considerations applicable to the shares of preferred stock;
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the relative ranking and preferences of the shares of preferred stock as to dividend rights and rights upon liquidation, dissolution or winding up of our affairs;
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any limitations on issuance of any series or class of shares of preferred stock ranking senior to or on a parity with such series or class of shares of preferred stock as to dividend rights and rights upon liquidation, dissolution or winding up of our affairs;
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any other specific terms, preferences, rights, limitations or restrictions of the shares of preferred stock; and
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any voting rights of such preferred stock.
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SUBSIDIARY/AFFILIATE NAME
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INCORPORATION
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Spectrum Oncology Private Limited
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India
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Spectrum Pharmaceuticals International Holdings, LLC
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Delaware
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Allos Therapeutics, Inc.
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Delaware
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Spectrum Pharmaceuticals Cayman, L.P. (1% Spectrum Pharmaceuticals International Holdings, LLC and 99% Spectrum Pharmaceuticals, Inc.)
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Cayman Islands
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Spectrum Pharmaceuticals, B.V.
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Netherlands
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Spectrum Pharmaceuticals Canada, Inc.
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Canada
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Talon Therapeutics, Inc.
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Delaware
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1.
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I have reviewed this Annual Report on Form 10-K of Spectrum Pharmaceuticals, Inc.;
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2.
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Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
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3.
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Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
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4.
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The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
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a.
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Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
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b.
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Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
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c.
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Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
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d.
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Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
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5.
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The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
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a.
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All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
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b.
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Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
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/s/ JOSEPH W. TURGEON
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Joseph W. Turgeon
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President and Chief Executive Officer
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(Chief Executive Officer)
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1.
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I have reviewed this Annual Report on Form 10-K of Spectrum Pharmaceuticals, Inc.;
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2.
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Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
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3.
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Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
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4.
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The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
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a.
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Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
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b.
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Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
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c.
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Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
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d.
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Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
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5.
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The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
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a.
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All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
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b.
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Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
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/s/ KURT A. GUSTAFSON
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Kurt A. Gustafson
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Executive Vice President and Chief Financial Officer
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(Principal Financial Officer)
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/s/ JOSEPH W. TURGEON
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Joseph W. Turgeon
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Chief Executive Officer and President
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/s/ KURT A. GUSTAFSON
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Kurt A. Gustafson
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Executive Vice President and Chief Financial Officer
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