Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Feb. 29, 2016 | Jun. 30, 2015 | |
Document And Entity Information [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2015 | ||
Document Fiscal Year Focus | 2,015 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | SPPI | ||
Entity Registrant Name | SPECTRUM PHARMACEUTICALS INC | ||
Entity Central Index Key | 831,547 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Accelerated Filer | ||
Entity Common Stock, Shares Outstanding | 68,163,483 | ||
Entity Public Float | $ 459,959,918 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Current assets: | ||
Cash and cash equivalents | $ 139,741 | $ 129,942 |
Marketable securities | 245 | 3,306 |
Accounts receivable, net of allowance for doubtful accounts of $120 and $120, respectively | 30,384 | 70,758 |
Other receivables | 12,572 | 5,489 |
Inventories | 4,176 | 9,200 |
Prepaid expenses and other assets | 4,206 | 3,774 |
Total current assets | 191,324 | 222,469 |
Property and equipment, net of accumulated depreciation | 918 | 1,405 |
Intangible assets, net of accumulated amortization | 190,335 | 230,100 |
Goodwill | 17,960 | 18,195 |
Other assets | 20,683 | 17,864 |
Total assets | 421,220 | 490,033 |
Current liabilities: | ||
Accounts payable and other accrued liabilities | 56,539 | 84,994 |
Accrued payroll and benefits | 8,188 | 8,444 |
Deferred revenue | 6,130 | 9,959 |
Drug development liability | 259 | 1,141 |
Acquisition-related contingent obligations | 5,227 | 4,901 |
Total current liabilities | 76,343 | 109,439 |
Drug development liability, less current portion | 14,427 | 14,644 |
Deferred revenue, less current portion | 383 | 0 |
Acquisition-related contingent obligations | 1,439 | 2,441 |
Deferred tax liability | 6,779 | 6,569 |
Other long-term liabilities | 7,444 | 6,088 |
Convertible senior notes | 101,548 | 96,298 |
Total liabilities | $ 208,363 | $ 235,479 |
Commitments and contingencies | ||
Stockholders’ equity: | ||
Common stock, $0.001 par value; 175,000,000 shares authorized; 68,228,935 and 65,969,699 issued and outstanding at December 31, 2015 and 2014, respectively | $ 68 | $ 66 |
Additional paid-in capital | 552,108 | 538,553 |
Accumulated other comprehensive loss | (5,319) | (850) |
Accumulated deficit | (334,123) | (283,338) |
Total stockholders’ equity | 212,857 | 254,554 |
Total liabilities and stockholders’ equity | 421,220 | 490,033 |
Series B Preferred Stock [Member] | ||
Stockholders’ equity: | ||
Preferred stock | 0 | 0 |
Series E Convertible Voting Preferred Stock [Member] | ||
Stockholders’ equity: | ||
Preferred stock | $ 123 | $ 123 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Allowance for doubtful accounts receivable | $ 120 | $ 120 |
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 175,000,000 | 175,000,000 |
Common stock, shares issued | 68,228,935 | 65,969,699 |
Common stock, shares outstanding | 68,228,935 | 65,969,699 |
Series B Junior Participating Preferred Stock [Member] | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 1,500,000 | 1,500,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Series E Convertible Voting Preferred Stock [Member] | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, stated value | $ 10,000 | $ 10,000 |
Preferred stock, shares authorized | 2,000 | 2,000 |
Preferred stock, shares issued | 20 | 20 |
Preferred stock, shares outstanding | 20 | 20 |
Convertible preferred shares | 40,000 | 40,000 |
Preferred stock, liquidation value | $ 240 | $ 240 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Revenues: | |||
Product sales, net | $ 136,851 | $ 186,537 | $ 143,475 |
License fees and service revenue | 25,705 | 293 | 12,379 |
Total revenues | 162,556 | 186,830 | 155,854 |
Operating costs and expenses: | |||
Cost of product sales (excludes amortization and impairment of intangible assets) | 27,689 | 27,037 | 28,580 |
Selling, general and administrative | 86,514 | 97,412 | 99,315 |
Research and development | 50,766 | 69,662 | 46,670 |
Amortization and impairment of intangible assets | 38,319 | 24,288 | 20,074 |
Total operating costs and expenses | 203,288 | 218,399 | 194,639 |
Loss from operations | (40,732) | (31,569) | (38,785) |
Other (expense) income: | |||
Interest expense, net | (9,074) | (8,584) | (2,192) |
Change in fair value of contingent consideration related to acquisitions | 676 | 987 | 2,871 |
Other (expense) income, net | (1,249) | (4,367) | 1,470 |
Total other (expense) income | (9,647) | (11,964) | 2,149 |
Loss before income taxes | (50,379) | (43,533) | (36,636) |
Provision for income taxes | (406) | (2,186) | (25,498) |
Net loss | $ (50,785) | $ (45,719) | $ (62,134) |
Net (loss) income per share: ($ per share) | |||
Basic ($ per share) | $ (0.78) | $ (0.71) | $ (1.02) |
Diluted ($ per share) | $ (0.78) | $ (0.71) | $ (1.02) |
Weighted average shares outstanding: (shares) | |||
Basic | 64,882,417 | 64,708,163 | 60,729,128 |
Diluted | 64,882,417 | 64,708,163 | 60,729,128 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Statement of Comprehensive Income [Abstract] | |||
Net loss | $ (50,785) | $ (45,719) | $ (62,134) |
Other comprehensive (loss) income, net of tax: | |||
Unrealized (loss) gain on available-for-sale securities | (1,429) | (1,122) | 690 |
Adjustment for realized gain on available-for-sale securities, and included in net income | 0 | (2,217) | 0 |
Foreign currency translation adjustments | (3,040) | 1,595 | (69) |
Other comprehensive (loss) income, net | (4,469) | (1,744) | 621 |
Total comprehensive loss | $ (55,254) | $ (47,463) | $ (61,513) |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Preferred Stock [Member] | Common Stock [Member] | Additional Paid-In Capital [Member] | Accumulated Other Comprehensive Income (Loss) [Member] | Accumulated Deficit [Member] | Treasury Stock [Member] | Total Stockholders Equity [Member] |
Beginning Balance at Dec. 31, 2012 | $ 123 | $ 60 | $ 463,710 | $ 273 | $ (175,485) | $ 0 | $ 288,681 | |
Beginning Balance, Shares at Dec. 31, 2012 | 20 | 60,026,675 | 0 | |||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Net income (loss) | $ (62,134) | (62,134) | (62,134) | |||||
Other comprehensive Income (loss), net | $ 621 | 621 | 621 | |||||
Issuance of common stock to 401(k) plan | 860 | 860 | ||||||
Issuance of common stock to 401(k) plan, Shares | 99,359 | |||||||
Issuance of common stock for ESPP | 495 | 495 | ||||||
Issuance of common stock for ESPP, Shares | 74,925 | |||||||
Issuance of common stock upon exercise of stock options | $ 1 | 3,576 | 3,577 | |||||
Issuance of common stock upon exercise of stock options, Shares | 825,884 | 825,884 | ||||||
Share-based compensation expense and common stock issued (net of forfeitures) | 11,193 | 11,193 | ||||||
Share-based compensation expense and common stock issued (net of forfeitures), Shares | 471,875 | |||||||
Repurchase of shares to satisfy employee tax withholding | (1,509) | (1,509) | ||||||
Repurchase of shares to satisfy employee tax withholding, Shares | (159,545) | |||||||
Purchase of treasury stock | $ (1,651) | (1,651) | ||||||
Purchase of treasury stock, Shares | 235,000,000 | |||||||
Retirement of treasury stock | $ (1,652) | (1,651) | $ 1,651 | 0 | ||||
Retirement of treasury stock, Shares | (235,000) | (235,000,000) | ||||||
Issuance of common stock for Talon acquisition | $ 3 | 26,307 | 26,310 | |||||
Issuance of common stock for Talon acquisition, Shares | 3,000,000 | |||||||
Issuance of 2018 Convertible Notes | 14,443 | 14,443 | ||||||
Ending Balance at Dec. 31, 2013 | $ 123 | $ 64 | 518,144 | 894 | (237,619) | $ 0 | 281,606 | |
Ending Balance, Shares at Dec. 31, 2013 | 20 | 64,104,173 | 0 | |||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Net income (loss) | (45,719) | (45,719) | (45,719) | |||||
Other comprehensive Income (loss), net | $ (1,744) | (1,744) | (1,744) | |||||
Issuance of common stock to 401(k) plan | 1,028 | 1,028 | ||||||
Issuance of common stock to 401(k) plan, Shares | 133,734 | |||||||
Issuance of common stock for ESPP | 639 | 639 | ||||||
Issuance of common stock for ESPP, Shares | 99,551 | |||||||
Issuance of common stock upon exercise of stock options | $ 1 | 1,905 | 1,906 | |||||
Issuance of common stock upon exercise of stock options, Shares | 485,260 | 485,260 | ||||||
Share-based compensation expense and common stock issued (net of forfeitures) | 10,781 | 10,781 | ||||||
Share-based compensation expense and common stock issued (net of forfeitures), Shares | 396,083 | |||||||
Repurchase of shares to satisfy employee tax withholding | (1,733) | (1,733) | ||||||
Repurchase of shares to satisfy employee tax withholding, Shares | (249,102) | |||||||
Retirement of treasury stock | $ 0 | |||||||
Issuance of common stock to TopoTarget for milestone achievement | $ 1 | 7,789 | 7,790 | |||||
Issuance of common stock to TopoTarget for milestone achievement, Shares | 1,000,000 | |||||||
Ending Balance at Dec. 31, 2014 | $ 254,554 | $ 123 | $ 66 | 538,553 | (850) | (283,338) | $ 0 | 254,554 |
Ending Balance, Shares at Dec. 31, 2014 | 65,969,699 | 20 | 65,969,699 | 0 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Net income (loss) | $ (50,785) | (50,785) | (50,785) | |||||
Other comprehensive Income (loss), net | (4,469) | (4,469) | (4,469) | |||||
Issuance of common stock to 401(k) plan | 1,124 | 1,124 | ||||||
Issuance of common stock to 401(k) plan, Shares | 179,865 | |||||||
Issuance of common stock for ESPP | 627 | 627 | ||||||
Issuance of common stock for ESPP, Shares | 114,578 | |||||||
Issuance of common stock upon exercise of stock options | $ 0 | 1,482 | 1,482 | |||||
Warrant modification | $ 568 | 568 | ||||||
Issuance of common stock upon exercise of stock options, Shares | 456,082 | 456,082 | ||||||
Share-based compensation expense and common stock issued (net of forfeitures) | $ 2 | 10,392 | 10,394 | |||||
Share-based compensation expense and common stock issued (net of forfeitures), Shares | 1,613,553 | |||||||
Repurchase of shares to satisfy employee tax withholding | (638) | (638) | ||||||
Repurchase of shares to satisfy employee tax withholding, Shares | (104,842) | |||||||
Retirement of treasury stock | 0 | |||||||
Ending Balance at Dec. 31, 2015 | $ 212,857 | $ 123 | $ 68 | $ 552,108 | $ (5,319) | $ (334,123) | $ 0 | $ 212,857 |
Ending Balance, Shares at Dec. 31, 2015 | 68,228,935 | 20 | 68,228,935 | 0 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Cash Flows From Operating Activities: | |||
Net loss | $ (50,785) | $ (45,719) | $ (62,134) |
Adjustments to reconcile net loss to net cash (used in) provided by operating activities: | |||
Amortization of deferred revenue | 0 | 0 | (12,400) |
Depreciation and amortization | 31,869 | 25,352 | 22,096 |
Stock-based compensation | 12,084 | 11,809 | 12,423 |
Change in fair value of common stock warrants issued to non-employees | 0 | 0 | 356 |
Accretion of debt discount, recorded to interest expense on 2018 Convertible Notes (Note 15) | 5,250 | 4,818 | 43 |
Amortization of deferred financing costs, recorded to interest expense on 2018 Convertible Notes (Note 15) | 662 | 599 | 101 |
Bad debt (recovery) expense | 0 | (85) | 127 |
Non-cash foreign currency exchange loss (income) | (157) | 6,033 | 1,222 |
Impairment of intangible assets (Note 3(g)) | 7,160 | 0 | 1,023 |
Change in fair value of contingent consideration related to Talon and EVOMELA acquisitions (Note 9) | (676) | (987) | (2,871) |
Change in fair value of Allos deferred development costs and deferred payment contingency (Note 16) | 0 | 0 | (2,869) |
Research and development expense recognized for BELEODAQ in-license milestone achievement (Note 17(b)(x)) | 0 | 7,790 | 0 |
Changes in operating assets and liabilities: | |||
Accounts receivable, net | 40,245 | (21,671) | 42,559 |
Other receivables | (7,017) | 2,070 | 0 |
Inventories | 1,863 | 4,253 | 1,570 |
Prepaid expenses and current portion of other assets | (446) | (718) | (359) |
Deferred tax assets | 0 | 1,724 | 33,252 |
Other assets | (1,731) | (13,161) | (8,989) |
Accounts payable and other accrued obligations | (28,298) | 5,304 | (23,897) |
Accrued payroll and benefits | (233) | 1,594 | 425 |
Drug development liability | (1,100) | (1,957) | (5,917) |
Deferred revenue | (3,511) | 9,803 | 0 |
Deferred tax liability | 210 | (602) | 0 |
Other long-term liabilities | 1,355 | 124 | 2,153 |
Net cash provided by (used in) operating activities | 6,744 | (3,627) | (2,086) |
Cash Flows From Investing Activities: | |||
Purchases of property and equipment | (223) | (934) | (161) |
Proceeds from sale of available-for-sale securities | 3,061 | 4,093 | 0 |
Net cash provided by (used in) investing activities | 2,838 | (21,841) | (14,330) |
Cash Flows From Financing Activities: | |||
Proceeds from Mundipharma related to FOLOTYN collaboration (Note 16) | 0 | 0 | 7,000 |
Proceeds from exercise of stock options | 1,482 | 1,906 | 3,576 |
Proceeds from sale of stock under employee stock purchase plan | 627 | 639 | 495 |
Purchase of treasury stock | 0 | 0 | (1,651) |
Purchase and retirement of restricted stock to satisfy employee tax liability at vesting | (638) | (1,733) | (1,509) |
Proceeds from revolving line of credit (Note 14) | 0 | 0 | 100,000 |
Repayment of revolving line of credit (Note 14) | 0 | 0 | (175,000) |
Proceeds from 2018 Convertible Notes (Note 15) | 0 | 0 | 120,000 |
Deferred financing costs (Note 15) | 0 | 0 | (4,573) |
Proceeds from sale of common stock warrants for 2018 Convertible Notes issuance (Note 15) | 0 | 0 | 12,612 |
Purchase of common stock call options related to 2018 Convertible Notes issuance (Note 15) | 0 | 0 | (25,692) |
Net cash provided by financing activities | 1,471 | 812 | 35,258 |
Effect of exchange rates on cash and equivalents | (1,254) | (1,708) | (2,235) |
Net (decrease) increase in cash and equivalents | 9,799 | (26,364) | 16,608 |
Cash and equivalents — beginning of year | 129,942 | 156,306 | 139,698 |
Cash and equivalents — end of year | 139,741 | 129,942 | 156,306 |
Supplemental Disclosure of Cash Flow Information: | |||
Cash paid for income taxes | 335 | 329 | 0 |
Cash paid for interest | 3,300 | 3,227 | 1,200 |
Retirement of treasury shares | 0 | 0 | 1,652 |
EVOMELA [Member] | |||
Cash Flows From Investing Activities: | |||
Acquisition | 0 | 0 | (3,000) |
Talon [Member] | |||
Cash Flows From Investing Activities: | |||
Acquisition | 0 | 0 | (11,169) |
Supplemental Disclosure of Cash Flow Information: | |||
Common stock issued for Talon acquisition | 0 | 0 | 26,310 |
BELEODAQ [Member] | |||
Cash Flows From Investing Activities: | |||
Capitalized milestone payment upon FDA approval of BELEODAQ | $ 0 | $ (25,000) | $ 0 |
Description of Business, Basis
Description of Business, Basis of Presentation, and Operating Segment | 12 Months Ended |
Dec. 31, 2015 | |
Accounting Policies [Abstract] | |
Description of Business, Basis of Presentation, and Operating Segment | DESCRIPTION OF BUSINESS, BASIS OF PRESENTATION, AND OPERATING SEGMENT (a) Description of Business Spectrum Pharmaceuticals, Inc. (“Spectrum”, the “Company”, “we”, “our”, or “us”) is a biotechnology company, with a primary strategy comprised of acquiring, developing, and commercializing a broad and diverse pipeline of late-stage clinical and commercial products. In addition to an in-house clinical development organization with regulatory and data management capabilities, we have established a commercial infrastructure for our marketed products. Currently, we have six approved oncology/hematology products that target different types of non-Hodgkin's lymphoma ("NHL"), advanced metastatic colorectal cancer, acute lymphoblastic leukemia ("ALL"), and multiple myeloma ("MM"). We also have two drugs in late stage development: • SPI-2012, is being developed for chemotherapy-induced neutropenia in patients with breast cancer. • EOQUIN® (previously referred to as APAZIQUONE for intravesical instillation), is being developed for immediate intravesical instillation post-transurethral resection of bladder tumors in patients with non-muscle invasive bladder cancer. (b) Basis of Presentation Principles of Consolidation The accompanying Consolidated Financial Statements in this Annual Report on Form 10-K have been prepared in accordance with generally accepted accounting principles in the United States of America (“GAAP”) and with the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”). These financial statements include the financial position, results of operations, and cash flows of Spectrum and its subsidiaries, all of which are wholly-owned (except for SPC, as discussed below). All inter-company accounts and transactions among these legal entities have been eliminated in consolidation. Variable Interest Entity We own fifty -percent of Spectrum Pharma Canada (“SPC”), a legal entity organized in Quebec, Canada in January 2008. Certain of our drug clinical studies are conducted through this “variable interest entity” (as defined under applicable GAAP) and we fund all of SPC’s operating costs. Since we carry the full risks and rewards of SPC, we meet the applicable GAAP criteria as being its “primary beneficiary.” Accordingly, SPC’s balance sheets and statements of operations are included in our Consolidated Financial Statements as if it were a wholly-owned subsidiary for all periods presented. (c) Operating Segment We operate in one reportable operating segment that is focused exclusively on developing and commercializing oncology and hematology drug products. For the years ended December 31, 2015 , 2014 , and 2013 , all of our revenue and related expenses were solely attributable to these activities. Substantially all of our assets (excluding our cash held in certain foreign bank accounts and our ZEVALIN distribution rights for the Ex-U.S. territory) are held in the U.S. |
Summary of Significant Accounti
Summary of Significant Accounting Policies and Use of Estimates | 12 Months Ended |
Dec. 31, 2015 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies and Use of Estimates | SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND USE OF ESTIMATES The preparation of financial statements in conformity with GAAP requires our management to make informed estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses. However, actual values may materially differ, since estimates are inherently uncertain. On an on-going basis, our management evaluates its estimates and assumptions, including those related to (i) gross-to-net revenue adjustments; (ii) the timing of revenue recognition; (iii) the collectability of customer accounts; (iv) whether the cost of inventories can be recovered; (v) the fair value of goodwill and intangible assets; (vi) the realization of tax assets and estimates of tax liabilities; (vii) the likelihood of payment and value of contingent liabilities; (viii) the fair value of investments; (ix) the valuation of stock options and the periodic expense recognition of stock-based compensation; and (x) the potential outcome of ongoing or threatened litigation. The estimates and assumptions that most significantly impact the presented amounts within these Consolidated Financial Statements are further described below: (i) Revenue Recognition (a) Product Sales : We sell our products to wholesalers/distributors (i.e., our customers), except for our U.S. sales of ZEVALIN in which case the end-user (i.e., clinic or hospital) is our customer. Our wholesalers distributors in turn sell our products directly to clinics, hospitals, and private oncology-based practices. Revenue from product sales is recognized when title and risk of loss have transferred to our customer, and the following additional criteria are met: (1) appropriate evidence of a binding arrangement exists with our customer; (2) price is substantially fixed and determinable; (3) collection from our customer is reasonably assured; (4) our customer’s obligation to pay us is not contingent on resale of the product; (5) we do not have significant continued performance obligations to our customer; and (6) we have a reasonable basis to estimate returns. Our gross revenue is reduced by our gross-to-net (“GTN”) estimates each period, resulting in our reported “product sales, net” in the accompanying Consolidated Statements of Operations. We defer revenue recognition in full if these estimates are not reasonably determinable at the time of sale. These estimates are based upon information received from external sources (such as written and oral information obtained from our customers with respect to their period-end inventory levels and their sales to end-users during the period), in combination with management’s informed judgments. Due to the inherent uncertainty of estimates, the actual amount we incur may be materially different than our GTN estimates, and require prospective revenue adjustments in periods after the initial sale was recorded. Our GTN estimates are comprised of the following categories: Product Returns Allowances : Our FUSILEV, MARQIBO, and BELEODAQ customers are permitted to return purchased products beginning at its expiration date and within six months thereafter. Returned product is generally not resold. Returns for expiry of ZEVALIN and FOLOTYN are not contractually, or customarily, allowed. We estimate expected returns based on historical return rates. Government Chargebacks : Our products are subject to pricing limits under certain federal government programs (e.g., Medicare and 340B Drug Pricing Program). Qualifying entities (i.e., end-users) purchase products from our customers at their qualifying discounted price. The chargeback amount we incur represents the difference between our contractual sales price to our customer, and the end-user’s applicable discounted purchase price under the government program. There may be significant lag time between our reported net product sales and our receipt of the corresponding government chargeback claims from our customers. Prompt Pay Discounts : Discounts for prompt payment are estimated at the time of sale, based on our eligible customers’ prompt payment history and the contractual discount percentage. Commercial Rebates : Commercial rebates are based on (i) our estimates of end-user purchases through a group purchasing organization ("GPO"), (ii) the corresponding contractual rebate percentage tier we expect each GPO to achieve, and (iii) our estimates of the impact of any prospective rebate program changes made by us. Medicaid Rebates : Our products are subject to state government-managed Medicaid programs, whereby rebates are issued to participating state governments. These rebates arise when a patient treated with our product is covered under Medicaid, resulting in a discounted price for our product under the applicable Medicaid program. Our Medicaid rebate accrual calculations require us to project the magnitude of our sales, by state, that will be subject to these rebates. There is a significant time lag in us receiving rebate notices from each state (generally several months or longer after our sale is recognized). Our estimates are based on our historical claim levels by state, as supplemented by management’s judgment. Distribution, Data, and GPO Administrative Fees : Distribution, data, and GPO administrative fees are paid to authorized wholesalers/distributors of our products (except for U.S. sales of ZEVALIN) for various commercial services, including: contract administration, inventory management, delivery of end-user sales data, and product returns processing. These fees are based on a contractually-determined percentage of our applicable sales. (b) License Fees : We recognize revenue for our licensing of intellectual property to third-parties (out-licenses), based on the contractual terms of each agreement and our application of pertinent GAAP. This revenue may be associated with upfront license fees, milestone payments from our licensees’ sales or regulatory achievements, and royalties from our licensees’ sales in applicable territories. (c) Service Revenue : We receive fees from third-parties under certain arrangements for our research and development activities, sales and marketing activities, clinical trial management, and supply chain services. Payment may be triggered by the successful completion of a phase of development, results from a clinical trial, regulatory approval events, or completion of product or service delivery in our capacity as an agent or principal in such arrangement. We recognize revenue when the corresponding milestone is achieved, or the revenue is otherwise earned and due to us through our on-going activities. (d) New Revenue Recognition Standard : On April 1, 2015, the FASB voted for a one-year deferral of the effective date of the new revenue recognition standard, ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606) (“ASU 2014-09”). ASU 2014-09 is now effective for us beginning January 1, 2018, requiring revenue recognition in a manner that reasonably reflects the delivery of our goods or services to customers in return for expected consideration. To achieve this core principle, the guidance provides the following steps: (1) identify the contract(s) with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when (or as) the entity satisfies a performance obligation. We intend to apply the cumulative effect transition method of ASU 2014-09, and we continue to evaluate the impact of this new standard to our current revenue recognition models for product sales , license fees , and service revenue , as described above. (ii) Cash and Cash Equivalents Cash and cash equivalents consist of bank deposits and highly liquid investments with maturities of three months or less from the purchase date. (iii) Marketable Securities Our marketable securities consist of our holdings in mutual funds and bank certificates of deposit. Since we classify these securities as “available-for-sale” under applicable GAAP, any unrealized gains or losses from their change in value is reflected in “unrealized (loss) gain on securities” on the accompanying Consolidated Statements of Comprehensive Loss. Realized gains and losses on available-for-sale securities are included in “other (expense) income, net” on the accompanying Consolidated Statements of Operations. (iv) Accounts Receivable Our accounts receivables are derived from our product sales, license fees, and service revenue, and do not bear interest. The allowance for doubtful accounts is management’s best estimate of the amount of probable credit losses in existing accounts receivable. Account balances are charged off against the allowance after appropriate collection efforts are exhausted. (v) Inventories We value inventory at the lower of (i) the actual cost of its purchase or manufacture, or (ii) its current market value. Inventory cost is determined on the first-in, first-out method (FIFO). We regularly review our inventory quantities in process of manufacture and on hand. When appropriate, we record a provision for obsolete and excess inventory to derive its new cost basis, which takes into account our sales forecast by product and corresponding expiry dates. Direct and indirect manufacturing costs related to the production of inventory prior to U.S. Food and Drug Administration ("FDA") approval are expensed through “research and development,” rather than being capitalized to inventory cost. (vi) Property and Equipment Our property and equipment is stated at historical cost, and is depreciated on a straight-line basis over an estimated useful life that corresponds with its designated asset category. We evaluate the recoverability of “long-lived assets” (which includes property and equipment) whenever events or changes in circumstances in our business indicate that the asset’s carrying amount may not be recoverable through on-going operations. (vii) Goodwill and Intangible Assets Our goodwill represents the excess of our business acquisition cost over the estimated fair value of the net assets acquired in the corresponding transaction. Goodwill has an indefinite accounting life and is therefore not amortized. Instead, goodwill is evaluated for impairment on an annual basis (as of each October 1st), unless we identify impairment indicators that would require earlier testing. We evaluate the recoverability of indefinite-lived intangible assets at least annually, or whenever events or changes in our business indicate that an intangible asset’s (whether indefinite or definite-lived) carrying amount may not be recoverable. Such circumstances could include, but are not limited to the following: (a) a significant decrease in the market value of an asset; (b) a significant adverse change in the extent or manner in which an asset is used; or (c) an accumulation of costs significantly in excess of the amount originally expected for the acquisition of an asset. Intangible assets with finite useful lives are amortized over their estimated useful lives on a straight-line basis. We review these assets for potential impairment if/when facts or circumstances suggest that the carrying value of these assets may not be recoverable. (viii) Stock-Based Compensation Stock-based compensation expense for equity awards granted to our employees and members of our board of directors is recognized on a straight-line basis over each award's vesting period. Recognized compensation expense is net of an estimated forfeiture rate, representing the percentage of awards that are expected to be forfeited (by termination of employment or service) prior to vesting. We use the Black-Scholes option pricing model to determine the fair value of stock options (as of the date of grant) which carry service conditions for vesting. We use the Monte Carlo valuation model to value equity awards (as of the date of grant) which carry combined market conditions and service conditions for vesting. The calculation of the fair value of stock options and the recognition of stock-based compensation expense requires uncertain assumptions, including (a) the pre-vesting forfeiture rate of the award, (b) the expected term of the stock option, (c) the stock price volatility over the term of the stock option, and (d) the risk-free interest rate over the term of the stock option. We estimate forfeiture rates based on our employees’ overall forfeiture history, which we believe will be representative of future results. We estimate the expected term of stock options granted based on our employees’ historical exercise patterns, which we believe will be representative of their future behavior. We estimate the volatility of our common stock on the date of grant based on historical volatility of our common stock for a look-back period that corresponds with the expected term. We estimate the risk-free interest rate based upon the U.S. Treasury yields in effect at award grant, for a period equaling the stock options’ expected term. (ix) Foreign Currency Translation We translate the assets and liabilities of our foreign subsidiaries that are stated in their functional currencies (i.e., local operating currencies), to U.S. dollars at the rates of exchange in effect at the reported balance sheet date. Revenues and expenses are translated using the monthly average exchange rates during the reported period. Unrealized gains and losses from the translation of our subsidiaries’ financial statements (that are initially denominated in the corresponding functional currency) are included as a separate component of “accumulated other comprehensive loss” in the Consolidated Balance Sheets. We record foreign currency transactions, when initially denominated in a currency other than the respective functional currency of our subsidiary, at the prevailing exchange rate on the date of the transaction. Resulting unrealized foreign exchange gains and losses from transactions with third parties are included in “accumulated other comprehensive loss” in the Consolidated Balance Sheets. Beginning April 1, 2015, all unrealized foreign exchange gains and losses associated with our intercompany loans were included in "accumulated other comprehensive loss" in the Consolidated Balance Sheets, as these loans with our foreign subsidiaries are no longer expected to be settled in the "foreseeable future." For the period January 1, 2015 through March 31, 2015, unrealized foreign exchange gains and losses associated with our intercompany loans were included in "accumulated other comprehensive loss" in the Consolidated Balance Sheets and in "other expense (income), net" in the Consolidated Statements of Operations. In periods prior to January 1, 2015, all unrealized foreign exchange gains and losses associated with intercompany loans were included in “other expense (income), net” in the Consolidated Statements of Operations. (x) Basic and Diluted Net (Loss) Income per Share We calculate basic and diluted net (loss) income per share using the weighted average number of common shares outstanding during the periods presented. In periods of a net loss, basic and diluted loss per share are the same. For the diluted earnings per share calculation, we adjust the weighted average number of common shares outstanding to include only dilutive stock options, warrants, and other common stock equivalents outstanding during the period. (xi) Income Taxes Deferred tax assets and liabilities are recorded based on the estimated future tax effects of temporary differences between the tax basis of assets and liabilities and amounts reported in the financial statements, as well as operating losses and tax credit carry forwards using enacted tax rates and laws that are expected to be in effect when the differences are expected to reverse. Realization of deferred tax assets is dependent upon future earnings, the timing and amount of which are uncertain. We have recorded a valuation allowance to reduce our net deferred tax assets, because we believe that, based upon a weighting of positive and negative factors, it is more likely than not that these deferred tax assets will not be realized. If/when we were to determine that our deferred tax assets are realizable, an adjustment to the corresponding valuation allowance would increase our net income in the period that such determination was made. In the event that we are assessed interest and/or penalties from taxing authorities that have not been previously accrued, such amounts would be included in “Provision for income taxes” within the Consolidated Statements of Operations in the period the notice was received. (xii) Research and Development Costs Research and development costs are expensed as incurred, or as certain milestone payments become due, generally triggered by contractual clinical or regulatory events. (xiii) Fair Value Measurements We determine measurement-date fair value based on the proceeds that would be received through the sale of the asset, or that we would pay to settle or transfer the liability, in an orderly transaction between market participants. We utilize valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible. Fair value measurements are based on a three-tier hierarchy that prioritizes the inputs used to measure fair value. These tiers include the following: Level 1: Quoted prices (unadjusted) in active markets for identical assets or liabilities that are publicly accessible at the measurement date. Level 2: Observable prices that are based on inputs not quoted on active markets, but that are corroborated by market data. These inputs may include quoted prices for similar assets or liabilities or quoted market prices in markets that are not active to the general public. Level 3: Unobservable inputs are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs. |
Balance Sheet Account Detail
Balance Sheet Account Detail | 12 Months Ended |
Dec. 31, 2015 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Balance Sheet Account Detail | BALANCE SHEET ACCOUNT DETAIL The composition of selected financial statement captions that comprise the accompanying Consolidated Balance Sheets are summarized below: (a) Cash and Cash Equivalents and Marketable Securities As of December 31, 2015 and December 31, 2014 , our holdings included in “cash and cash equivalents” and “marketable securities” were at major financial institutions. Our investment policy requires that investments in marketable securities be in only highly-rated instruments, which are primarily U.S. treasury bills or U.S. treasury-backed securities, and limited investments in securities of any single issuer. We maintain cash balances in excess of federally insured limits with reputable financial institutions. To a limited degree, the Federal Deposit Insurance Corporation (FDIC) and other third parties insure these investments. However, these investments are not insured against the possibility of a complete loss of earnings or principal and are inherently subject to the credit risk related to the continued credit worthiness of the underlying issuer and general credit market risks. We manage such risks on our portfolio by investing in highly liquid, highly rated instruments, and limit investing in long-term maturity instruments. The carrying amount of our equity securities, money market funds, bank certificate of deposits (“Bank CDs”), and mutual funds approximates their fair value (utilizing Level 1 or Level 2 inputs – see Note 2 (xiii) ) because of our ability to immediately convert these instruments into cash with minimal expected change in value. The following is a summary of our presented “cash and cash equivalents” and “marketable securities”: Cost Gross Gross Estimated Cash and Marketable Securities Current Long December 31, 2015 Bank deposits $ 59,625 $ — $ — $ 59,625 $ 59,625 $ — $ — Money market funds 80,116 — — 80,116 80,116 — — Bank certificate of deposits 245 — — 245 — 245 — Total cash and equivalents and marketable securities $ 139,986 $ — $ — $ 139,986 $ 139,741 $ 245 $ — December 31, 2014 Bank deposits $ 62,997 $ — $ — $ 62,997 $ 62,997 $ — $ — Money market funds 66,945 — — 66,945 66,945 — — Bank certificate of deposits 244 — — 244 — 244 — Mutual funds 3,062 — — 3,062 — 3,062 — Total cash and equivalents and marketable securities $ 133,248 $ — $ — $ 133,248 $ 129,942 $ 3,306 $ — As of December 31, 2015 , none of these securities had been in a continuous unrealized loss position longer than one year. (b) Property and Equipment “Property and equipment, net of accumulated depreciation” consist of the following: December 31, 2015 2014 Computers hardware and software $ 3,785 $ 3,616 Laboratory equipment 608 643 Office furniture 355 344 Leasehold improvements 2,872 2,847 Property and equipment, at cost 7,620 7,450 (Less): Accumulated depreciation (6,702 ) (6,045 ) Property and equipment, net of accumulated depreciation $ 918 $ 1,405 Depreciation expense (included within “total operating costs and expenses” in the accompanying Consolidated Statements of Operations) for the years ended December 31, 2015 , 2014 , and 2013 was $0.7 million , $1.1 million , and $1.2 million , respectively. (c) Inventories “Inventories” consist of the following: December 31, 2015 2014 Raw materials $ 1,606 $ 1,507 Work in process* 4,228 3,979 Finished goods 1,498 3,714 (Less:) Non-current portion of inventories included within "other assets" ** $ (3,156 ) $ — Inventories $ 4,176 $ 9,200 *Our work-in-process inventory at December 31, 2015 includes $0.8 million of packaged but unlabeled ZEVALIN vials with expiry in December 2017 (with possible extensions thereafter). In addition to the amounts presented at December 31, 2015, we received $3.4 million of ZEVALIN antibody materials in January 2016 for its future manufacture (representing strategic long-term supply). We expect to sell our existing and committed ZEVALIN inventory over the next few years. However, if our production strategy changes in our transition to a new contract manufacturer, it could result in a charge in that period to “cost of product sales (excludes amortization of intangible assets)” within the Consolidated Statements of Operations. ** The non-current portion of inventories included within "other assets" at December 31, 2015 of $3.2 million , represents inventories we don't expect to sell within the next twelve months based on current estimates. (d) Accounts receivables, net of allowance for doubtful accounts “Accounts receivables, net” consists of trade receivables from our customers. We are exposed to credit risk associated with trade receivables that result from these product sales. We do not require collateral or deposits from our customers due to our assessment of their creditworthiness and our long-standing relationship with them. We maintain reserves for potential bad debt, though credit losses have historically been nominal and within management’s expectations. A summary of our customers that represent 10% or more of our accounts receivables as of December 31, 2015 and 2014 are as follows: Year Ended December 31, 2015 2014 McKesson Corporation and its affiliates $ 20,281 66.7 % $ 22,534 31.9 % Cardinal Health, Inc. and its affiliates 7,241 23.8 % 8,432 11.9 % Oncology Supply, a division of ASD Specialty Healthcare, Inc., and its affiliates (excluding ICS) * — % 36,154 51.1 % All other customers 2,862 9.4 % 3,638 5.1 % Total Accounts Receivables, net $ 30,384 100.0 % $ 70,758 100.0 % * Less than 10% (e) Prepaid expenses and other assets “Prepaid expenses and other assets” consist of the following: December 31, 2015 2014 Prepaid operating expenses $ 3,507 $ 3,112 2018 Convertible Notes issuance costs (current portion) 699 662 Prepaid expenses and other assets $ 4,206 $ 3,774 (f) Other receivables “Other receivables” consist of the following: December 31, 2015 2014 Income tax receivable $ 1,301 $ 1,387 Insurance receivable 7,100 — Mundipharma promissory note 2,215 — Research and development expenses - reimbursements due 1,699 4,102 Other miscellaneous receivables 257 — Other receivables $ 12,572 $ 5,489 (g) Intangible Assets and Goodwill “Intangible assets, net of accumulated amortization” consist of the following: December 31, 2015 Historical Accumulated Foreign Impairment Net Amount Full Remaining MARQIBO IPR&D (NHL indication) $ 17,600 $ — $ — $ — $ 17,600 n/a n/a EVOMELA IPR&D 7,700 — — — 7,700 n/a n/a BELEODAQ distribution rights 25,000 (2,812 ) — — 22,188 160 142 MARQIBO distribution rights 26,900 (8,544 ) — — 18,356 81 51 FOLOTYN distribution rights 118,400 (29,474 ) — — 88,926 152 113 ZEVALIN distribution rights – U.S. 41,900 (30,608 ) — — 11,292 123 39 ZEVALIN distribution rights – Ex-U.S. 23,490 (12,632 ) *** (4,353 ) — 6,505 96 51 FUSILEV distribution rights* 16,778 (9,618 ) — (7,160 ) — 56 0 FOLOTYN out-license** 27,900 (9,109 ) — (1,023 ) 17,768 110 79 Total intangible assets $ 305,668 $ (102,797 ) $ (4,353 ) $ (8,183 ) $ 190,335 * On February 20, 2015, the U.S. District Court for the District of Nevada found the patent covering FUSILEV to be invalid, which was upheld on appeal. On April 24, 2015, Sandoz began to commercialize a generic version of FUSILEV. This represented a “triggering event” under applicable GAAP in evaluating the value of our FUSILEV distribution rights as of March 31, 2015, resulting in a $7.2 million impairment charge (non-cash) in the first quarter of 2015. We accelerated amortization expense recognition for the remaining net book value of FUSILEV distribution rights. ** On May 29, 2013, we amended our FOLOTYN collaboration agreement with Mundipharma. As a result of the amendment, Europe and Turkey were excluded from Mundipharma’s commercialization territory, and their royalty rates and milestone payments to us were modified. This constituted a change under which we originally valued the FOLOTYN out-license as part of business combination accounting, resulting in an impairment charge (non-cash) of $1.0 million resulted from this amendment. *** This value is inclusive of $3.7 million of accelerated amortization expense, recorded in the fourth quarter of 2015, which specifically relates to our allocation of the historical cost of certain ZEVALIN ex-U.S. rights out-licensed to Mundipharma (see Note 12 ) at that time. Our annual impairment evaluation (as of October 1 st ) of our indefinite-lived intangible assets was completed by our management, with no resulting impairment. The assets under review included MARQIBO IPR&D and EVOMELA IPR&D, which we carry on our accompanying Consolidated Balance Sheet as of December 31, 2015 , at $17.6 million and $7.7 million , respectively. December 31, 2014 Historical Cost Accumulated Amortization Foreign Currency Translation Impairment Net Amount MARQIBO IPR&D (NHL indications) $ 17,600 $ — $ — $ — $ 17,600 EVOMELA IPR&D 7,700 — — — 7,700 BELEODAQ distribution rights 25,000 (937 ) — — 24,063 MARQIBO distribution rights 26,900 (4,225 ) — — 22,675 FOLOTYN distribution rights 118,400 (20,030 ) — — 98,370 ZEVALIN distribution rights – U.S. 41,900 (27,134 ) — — 14,766 ZEVALIN distribution rights – Ex-U.S. 23,490 (7,402 ) (2,162 ) — 13,926 FUSILEV distribution rights 16,778 (6,270 ) — — 10,508 FOLOTYN out-license 27,900 (6,385 ) — (1,023 ) 20,492 Total intangible assets $ 305,668 $ (72,383 ) $ (2,162 ) $ (1,023 ) $ 230,100 Intangible asset amortization and impairment expense recognized in 2015 , 2014 , and 2013 was $38.3 million , $24.3 million , and $21.2 million , respectively. Estimated intangible asset amortization expense (excluding incremental amortization from the reclassification of IPR&D to developed technology) for the five succeeding years and thereafter is as follows: Years Ending December 31 2016 $ 23,360 2017 23,368 2018 23,368 2019 20,762 2020 15,505 2021 and thereafter 58,672 $ 165,035 “Goodwill” is comprised of the following: December 31, 2015 2014 Acquisition of Talon $ 10,526 $ 10,526 Acquisition of ZEVALIN Ex-U.S. distribution rights 2,525 2,525 Acquisition of Allos 5,346 5,346 Foreign currency exchange translation effects (437 ) (202 ) Goodwill $ 17,960 $ 18,195 (h) Other assets “Other assets” are comprised of the following: December 31, 2015 2014 Equity securities and secured promissory note (see Note 11 )* $ 6,689 $ 8,501 Supplies and deposits 185 234 2018 Convertible Notes issuance costs (excluding current portion)** 1,472 2,171 Executive officer life insurance – cash surrender value 9,181 6,958 Inventories - non-current portion $ 3,156 $ — Other assets $ 20,683 $ 17,864 * These equity securities were excluded from “marketable securities” (see Note 3(a) ) due to our intent to hold these securities for at least one year beyond December 31, 2015 , as discussed in Note 11 . Unrealized losses from these equity securities were recognized through “unrealized (loss) gain on available-for-sale securities" within the Consolidated Statements of Comprehensive Loss, and were $1.4 million for the year ended December 31, 2015 . ** In April 2015, the FASB issued Accounting Standards Update 2015-03, Simplifying the Presentation of Debt Issuance Costs (“ASU 2015-03”). ASU 2015-03 requires that debt issuance costs related to a recognized debt liability be presented in the balance sheet as a direct deduction from the carrying amount of that debt liability. However, ASU 2015-03 does not impact the recognition and measurement guidance for debt issuance costs. ASU 2015-03 is effective for our annual and interim reporting periods beginning January 1, 2016. Accordingly, we will record a reclassification of our 2018 Convertible Notes issuance costs, from “other assets” to “convertible senior notes” within our Consolidated Balance Sheets, beginning January 1, 2016. (i) Accounts payable and other accrued obligations Accounts payable and other accrued obligations are comprised of the following: December 31, 2015 2014 Trade accounts payable and other accrueds $ 26,684 $ 24,571 Accrued rebates 18,166 41,782 Accrued product royalty 4,908 5,182 Allowance for returns 1,394 1,135 Accrued data and distribution fees 1,830 3,952 Accrued GPO administrative fees 1,058 3,222 Inventory management fee 498 1,110 Allowance for chargebacks 2,001 4,040 Accounts payable and other accrueds $ 56,539 $ 84,994 Amounts presented within “accounts payable and other accrued liabilities” in the accompanying Consolidated Balance Sheets for GTN estimates (see Note 2(i) ) were as follows: Description Rebates and Data and Returns Balance as of December 31, 2013 $ 33,967 $ 5,373 $ 2,900 Add: provisions (recovery) 76,636 21,330 (78 ) (Less): credits or actual allowances (64,781 ) (18,419 ) (1,687 ) Balance as of December 31, 2014 45,822 8,284 1,135 Add: provisions 75,498 15,928 1,486 (Less): credits or actual allowances (101,153 ) (20,826 ) (1,227 ) Balance as of December 31, 2015 $ 20,167 $ 3,386 $ 1,394 (j) Deferred revenue Deferred revenue (including current and long-term) is comprised of the following: December 31, 2015 2014 CASI out-license (see Note 11) $ — $ 9,959 FUSILEV deferred revenue* 6,083 — Dr. Reddy's out-license (see Note 17(b)(iii)) 430 — Deferred revenue $ 6,513 $ 9,959 * During the third quarter 2015, we deferred revenue recognition related to certain FUSILEV product shipments that did not meet our revenue recognition criteria (see Note 2(i)(a) ), aggregating $9.9 million . Specifically, this deferral is a result of our inability to estimate future rebate values (with requisite precision) offered to our customers in order to compete with generic products. During the fourth quarter of 2015, we recognized $3.8 million for these third quarter shipments within "Product sales, net." As of December 31, 2015 , $6.1 million of these third quarter 2015 shipments remains deferred. (k) Other long-term liabilities Other long-term liabilities are comprised of the following: December 31, 2015 2014 Accrued executive deferred compensation $ 6,458 $ 4,694 Deferred rent (non-current portion) 248 364 Business acquisition liability — 300 Other tax liabilities 738 730 Other long-term liabilities $ 7,444 $ 6,088 |
Gross-to-Net Product Sales
Gross-to-Net Product Sales | 12 Months Ended |
Dec. 31, 2015 | |
Revenue, Net [Abstract] | |
Gross-to-Net Product Sales | GROSS-TO-NET PRODUCT SALES The below table presents a GTN product sales reconciliation for the accompanying Consolidated Statement of Operations: 2015 2014 2013 Gross product sales $ 215,136 $ 284,685 $ 224,301 Commercial rebates and government chargebacks (61,283 ) (76,636 ) (63,610 ) Distribution, data, and GPO administrative fees (15,613 ) (21,330 ) (19,067 ) Prompt pay discounts (16 ) (260 ) (183 ) Product returns allowances (1,373 ) 78 2,034 Product sales, net $ 136,851 $ 186,537 $ 143,475 |
Net Product Sales by Geographic
Net Product Sales by Geographic Region, Product Line, and Gross Product Sales by Significant Customers | 12 Months Ended |
Dec. 31, 2015 | |
Segment Reporting [Abstract] | |
Net Product Sales by Geographic Region, Product Line, and Gross Product Sales by Significant Customers | NET PRODUCT SALES BY GEOGRAPHIC REGION, PRODUCT LINE, AND GROSS PRODUCT SALES BY SIGNIFICANT CUSTOMERS The below table presents our net product sales by geography for the years ended December 31, 2015 , 2014 , and 2013 : Net Product Sales by Geographic Region Year Ended December 31, 2015 2014 2013 United States $ 130,432 95.3 % $ 177,979 95.4 % $ 133,462 93.0 % International: Europe (ZEVALIN and FOLOTYN only) 2,234 1.6 % 3,357 1.8 % 3,953 2.8 % Asia Pacific (ZEVALIN only) 4,185 3.1 % 5,201 2.8 % 6,060 4.2 % Total International 6,419 4.7 % 8,558 4.6 % 10,013 7.0 % Net product sales $ 136,851 100 % $ 186,537 100.0 % $ 143,475 100.0 % Net Sales by Product The below table presents our net product sales by product for the years ended December 31, 2015 , 2014 , and 2013 : Year Ended December 31, 2015 2014 2013 FUSILEV $ 60,710 44.4 % $ 105,608 56.6 % $ 68,397 47.7 % FOLOTYN 40,606 29.7 % 47,556 25.5 % 44,370 30.9 % ZEVALIN 17,457 12.8 % 22,169 11.9 % 29,393 20.5 % MARQIBO 8,006 5.9 % 6,328 3.4 % 1,315 0.9 % BELEODAQ 10,072 7.4 % 4,876 2.6 % — — % Net product sales $ 136,851 100.0 % $ 186,537 100.0 % $ 143,475 100.0 % Gross Product Sales by Customer The below table presents the customers that represent 10% or more of our gross product sales in 2015 , 2014 , and 2013 : Year Ended December 31, 2015 2014 2013 Oncology Supply, a division of ASD Specialty Healthcare, Inc., and its affiliates (excluding ICS) $ 78,989 36.7 % $ 115,079 40.4 % $ 79,497 35.4 % McKesson Corporation and its affiliates 73,577 34.2 % 93,656 32.9 % 44,350 19.8 % Integrated Commercialization Solutions, Inc. (“ICS”) * — % * — % 35,548 15.8 % Cardinal Health, Inc. and its affiliates 37,414 17.4 % * — % * — % All Other Customers 25,156 11.7 % 75,950 26.7 % 64,906 29.0 % Gross product sales $ 215,136 100.0 % $ 284,685 100.0 % $ 224,301 100.0 % * Less than 10% |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2015 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock-Based Compensation | STOCK-BASED COMPENSATION 2009 Stock Incentive Plan Overview We have one active stockholder-approved stock-based compensation plan, the 2009 Incentive Award Plan (the “2009 Plan”), which replaced our former stockholder-approved plans. We may grant incentive stock options, non-qualified options, restricted stock awards, and stock appreciation rights under the 2009 Plan. The maximum number of our common stock available for issuance under the 2009 Plan at inception was 10 million shares. Beginning on January 1, 2010, and each January 1st thereafter, the number of shares of common stock available for issuance under the 2009 Plan automatically increases by the greater of (i) 2.5 million shares or (ii) a number of shares such that the total number of shares of common stock available for issuance under the 2009 Plan shall equal 30% of the then number of shares of common stock issued and outstanding. As of December 31, 2015 , 8.6 million shares were available for grant. It is our policy that before stock is issued through the exercise of stock options, we must first receive all required cash payment for such shares (whether through an upfront cash exercise or net-settlement exercise). Stock-based awards are governed by agreements between us and the recipients. Incentive stock options and nonqualified stock options may be granted under the 2009 Plan at an exercise price of not less than 100% of the closing fair market value of our common stock on the respective date of grant. The grant date is generally the date the award is approved by the Compensation Committee of the Board of Directors, though for aggregate awards of 50,000 or less in each quarter, the grant date is the date the award is approved by our Chief Executive Officer. Stock-based awards generally vest 25% on the first anniversary of the date of grant, or for new hires, the first anniversary of their initial date of employment. Awards generally vest monthly thereafter on a straight-line basis over three years. Stock options must be exercised, if at all, no later than 10 years from the date of grant. Upon termination of employment, vested stock options may be exercised within 90 days from the last date of employment. In the event of an optionee’s death, disability, or retirement, the exercise period is 365 days from the last date of employment. Employee Stock Purchase Plan Under the terms of our 2009 Employee Stock Purchase Plan (the “ESPP”), eligible employees can purchase common stock through payroll deductions. The purchase price is equal to the closing price of our common stock on the first or last day of the offering period (whichever is less), minus a 15% discount. We use the Black-Scholes option-pricing model, in combination with the discounted employee price, in determining the value of ESPP expense to be recognized during each offering period. A participant may purchase a maximum of 50,000 shares of common stock during a six -month offering period, not to exceed $25,000 worth of stock on the offering date during each plan year. A total of 4.3 million shares of common stock are authorized for issuance under the ESPP. Beginning on January 1, 2010, and each January 1st thereafter, the number of shares of common stock available for issuance under the ESPP shall automatically increase by an amount equal to the lesser of (i) one million shares or (ii) an amount determined by the ESPP administrator. However, in no event shall the number of shares of common stock available for future sale under the ESPP exceed 10 million shares, subject to capitalization adjustments occurring due to dividends, splits, dissolution, liquidation, mergers, or changes in control. Stock-Based Compensation Expense Summary We classify our stock-based compensation expense (inclusive of our incentive stock plan, employee stock purchase plan, and 401(k) contribution matching program) in the accompanying Consolidated Statements of Operations, based on the department to which the recipient belongs. Stock-based compensation expense included within “Total operating costs and expenses” for years ended December 31, 2015 , 2014 and 2013 was as follows: Year Ended December 31, 2015 2014 2013 Cost of product sales $ 62 $ — $ — Selling, general and administrative 10,049 10,053 10,762 Research and development 1,973 1,756 2,017 Total $ 12,084 $ 11,809 $ 12,779 Employee stock-based compensation expense for the years ended December 31, 2015 , 2014 and 2013 was recognized (reduced for estimated forfeitures) on a straight-line basis over the vesting period. Forfeitures are estimated at the time of grant and prospectively revised if actual forfeitures differ from those estimates. We estimate forfeitures of stock options using the historical exercise behavior of our employees. For purposes of this estimate, we have applied an estimated forfeiture rate of 11% , 8% , and 8% for the years ended December 31, 2015 , 2014 and 2013 . Valuation Assumptions – Restricted Stock and Stock Options The grant-date fair value per share for restricted stock awards was based upon the closing market price of our common stock on the award grant-date. The fair value of stock options granted was estimated at the date of grant using the Black-Scholes option-pricing model. The following assumptions were used to determine fair value for the stock awards granted in the applicable year: Year Ended December 31, 2015 2014 2013 Expected option life (in years) (a) 5.43 4.95 4.95 Risk-free interest rate (b) 1.25% - 1.68% 0.58% - 1.52% 0.35% - 0.78% Volatility (c) 48.0% - 50.2% 48.9% - 62.1% 58.3% -71.5% Dividend yield (d) —% —% —% Weighted-average grant-date fair value per stock option $2.85 $3.49 $4.66 (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. Stock Option Activity Stock option activity during the years ended December 31, 2015 , 2014 and 2013 is as follows: Number of Weighted- Weighted- Aggregate Outstanding — December 31, 2012 10,399,265 $ 6.57 Granted 2,041,300 8.92 Exercised (825,884 ) 4.40 $ 3,435 (1 ) Forfeited (202,882 ) 8.22 Expired (82,581 ) 8.91 Outstanding — December 31, 2013 11,329,218 7.10 Granted 2,576,292 7.60 Exercised (485,260 ) 4.77 $ 1,629 (1 ) Forfeited (557,109 ) 9.65 Expired (214,039 ) 10.70 Outstanding — December 31, 2014 12,649,102 7.12 Granted 2,219,587 6.04 Exercised (456,082 ) 4.45 $ 977 (1 ) Forfeited (296,162 ) 8.06 Expired (279,594 ) 9.05 Outstanding — December 31, 2015 13,836,851 $ 6.97 6.34 $ 7,516 (2 ) Vested (exercisable) — December 31, 2015 10,235,721 $ 6.94 5.40 $ 7,159 (2 ) Unvested (unexercisable) — December 31, 2015 3,601,130 $ 7.06 9.00 $ 357 (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 2015 and the stock option exercise price, multiplied by the number of in-the-money options as of December 31, 2015 . The amount of intrinsic value will change based on the fair market value of our stock. The following table summarizes information with respect to stock option grants as of December 31, 2015 : Outstanding Exercisable Exercise Price Granted Stock Weighted- Weighted- Granted Weighted- $0.92 - 3.15 1,090,385 2.49 $ 2.18 1,090,385 $ 2.18 $3.16 - 4.95 1,378,444 4.29 4.24 1,378,444 4.24 $4.96 - 6.9 4,394,294 6.14 6.08 2,999,511 6.22 $6.91 - 8.99 4,500,895 7.61 7.78 2,595,943 7.95 $9.00 - 16.32 2,472,833 7.21 10.71 2,171,438 10.83 13,836,851 6.34 $ 6.97 10,235,721 $ 6.94 As of December 31, 2015 , there was unrecognized compensation expense of $8.8 million related to unvested stock options, which we expect to recognize over a weighted average period of 2.41 years. Restricted Stock Award Activity A summary of restricted stock award activity is as follows: Number of Weighted Average Unvested — December 31, 2012 1,034,604 $ 11.00 Granted 523,800 8.74 Vested (501,660 ) 9.72 Forfeited (49,625 ) 10.60 Unvested — December 31, 2013 1,007,119 10.09 Granted 581,194 7.52 Vested (578,985 ) 10.24 Forfeited (185,111 ) 9.88 Unvested — December 31, 2014 824,217 8.22 Granted 1,948,585 6.32 Vested (364,507 ) 8.47 Forfeited (234,313 ) 7.32 Unvested — December 31, 2015 2,173,982 $ 6.58 2015 2014 2013 Restricted stock expense $ 4,006 $ 3,830 $ 4,202 As of December 31, 2015 , there was approximately $9.8 million of unrecorded expense related to issued restricted stock that will be recognized over an estimated weighted average period of 2.29 years. These unvested shares are included in our issued and outstanding common stock as of December 31, 2015 . 401(k) Plan – Stock Matching Contribution We issued shares of common stock to our employees in connection with our 401(k) program, partially matching our employees’ annual 401(k) contributions, as summarized below: 2015 2014 2013 Shares of common stock issued 179,865 133,734 99,359 Match contribution value* $ 1,124 $ 1,028 $ 860 * Represents our stock price on the date of the common stock issuance multiplied by the number of shares of common stock issued. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2015 | |
Equity [Abstract] | |
Stockholders' Equity | STOCKHOLDERS’ EQUITY Authorized Stock On December 13, 2010, we filed the Certificate of Designation of Rights, Preferences and Privileges of Series B Junior Participating Preferred Stock with the Delaware Secretary of State which authorized 1.5 million shares to be designated as Series B Junior Participating Preferred Stock. On June 13, 2011, our stockholders approved an amendment to our Certificate of Incorporation to increase the authorized number of shares of our common stock from 100 million shares to 175 million shares. The amendment was filed with the Delaware Secretary of State on June 24, 2011. As of December 31, 2015 , we also had five million shares of preferred stock authorized, of which 1.5 million shares were designated as Series B Junior Participating Preferred Stock and 2,000 shares were designated as Series E Convertible Voting Preferred Stock. Stockholder Rights Agreement On November 29, 2010, our Board of Directors approved a replacement rights agreement, effective December 13, 2010, that replaced the stockholder rights agreement which was originally adopted in 2000. This replacement rights agreement will extend until December 13, 2020 . A stockholder rights agreement is designed to deter coercive, unfair, or inadequate takeovers and other abusive tactics that might be used in an attempt to gain control of our company. A stockholder rights agreement will not prevent takeovers at a full and fair price, but rather is designed to deter coercive takeover tactics and to encourage anyone attempting to acquire our company to first negotiate with our Board of Directors. Under the terms of the new Stockholder Rights Agreement, the rights become exercisable upon the earlier of 10 days after a person or group of affiliated or associated persons has acquired 15% or more of the outstanding shares of our common stock or 10 business days after a tender offer has commenced that would result in a person or group beneficially owning 15% or more of our outstanding common stock. These rights could delay or discourage someone from acquiring our company, even if doing so would potentially benefit our stockholders. We currently have no stockholders who own 15% or more of the outstanding shares of our common stock. five days after the rights become exercisable, each right, other than rights held by the person or group of affiliated persons whose acquisition of more than 15% of our outstanding common stock caused the rights to become exercisable, will entitle its holder to buy, in lieu of shares of Series B Preferred Stock, a number of shares of our common stock having a market value of two times the exercise price of the rights. After the rights become exercisable, if we are a party to certain merger or business combination transactions or transfers 50% or more of our assets or earnings power (as defined in the Stockholder Rights Agreement), each right will entitle its holder to buy a number of shares of common stock of the acquiring or surviving entity having a market value of twice the exercise price of the right. Series E Preferred Stock In September 2003, we received gross cash proceeds of $20 million in exchange for the issuance of 2,000 shares of our Series E Convertible Voting Preferred Stock, convertible into four million shares of common stock. As of December 31, 2015 and 2014 , 20 shares of Series E Preferred Stock were outstanding. No dividends are payable on the Series E Preferred Stock. Pursuant to certain provisions of the Certificate of Designation, Rights and Preferences of the Series E Preferred Stock, we have the option to redeem all of the unconverted Series E Preferred Stock outstanding at the end of a 20 -day trading period if, among other things, in that period our common stock trades above $12.00 per share. In the event we are the subject of any voluntary or involuntary liquidation, dissolution or winding up, before any distribution of our assets shall be made to the common stockholders, the holders of the Series E Preferred Stock shall be entitled to receive a liquidation preference in an amount equal to 120% of the stated value per share plus any declared and unpaid dividends thereon. Common Stock Issuable As of December 31, 2015 , 26 million shares of our common stock were issuable upon conversion, or exercise of rights granted (regardless of whether in or out-of-the-money), as summarized below: Conversion of Series E Preferred Stock 40,000 2018 Convertible Notes 11,401,284 Exercise of issued employee stock options 13,836,851 Exercise of issued warrants 445,000 Management incentive plan restricted stock units 260,000 Total common shares 25,983,135 Warrant Activity We typically issue warrants to purchase shares of our common stock to investors as part of a financing transaction or in connection with services rendered by placement agents or consultants. Our outstanding warrants expire on varying dates through December 2020 . A summary of warrant activity is as follows: Number of Weighted Outstanding — December 31, 2012 395,000 $ 5.45 Granted 50,000 7.51 Outstanding — December 31, 2013 445,000 $ 6.39 Granted — — Outstanding — December 31, 2014 445,000 $ 6.39 Granted — — Outstanding — December 31, 2015 445,000 $ 6.78 Exercisable — December 31, 2015 445,000 $ 6.78 |
Net Loss Per Share
Net Loss Per Share | 12 Months Ended |
Dec. 31, 2015 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | NET LOSS PER SHARE Net loss per share was computed by dividing net loss by the weighted average number of common shares outstanding for the years ended December 31, 2015 , 2014 , and 2013 : Year Ended December 31, 2015 2014 2013 Net loss $ (50,785 ) $ (45,719 ) $ (62,134 ) Weighted average shares—basic 64,882,417 64,708,163 60,729,128 Net loss per share—basic $ (0.78 ) $ (0.71 ) $ (1.02 ) Weighted average shares—diluted 64,882,417 64,708,163 60,729,128 Net loss income per share—diluted $ (0.78 ) $ (0.71 ) $ (1.02 ) The below outstanding securities were excluded from the above calculation of net loss per share because their impact would have been anti-dilutive due to net loss per share, for the years ended, as summarized below: Year Ended December 31, 2015 2014 2013 2018 Convertible Notes 11,401,284 11,401,284 343,600 Common stock options 1,441,086 2,173,916 2,934,625 Restricted stock awards 2,173,615 824,217 1,007,119 Common stock warrants 9,357 120,702 160,816 Preferred stock 40,000 40,000 40,000 Total 15,065,342 14,560,119 4,486,160 |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2015 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | FAIR VALUE MEASUREMENTS The table below summarizes certain asset and liability fair values that are included within our accompanying Consolidated Balance Sheets, and their designations among three fair value measurement categories: December 31, 2015 Level 1 Level 2 Level 3 Total Assets: Bank certificates of deposits $ — $ 245 $ — $ 245 Money market currency funds — 80,116 — 80,116 Equity securities 5,189 — — 5,189 Mutual funds — — — — Deferred compensation investments, including life insurance cash surrender value — 9,181 — 9,181 $ 5,189 $ 89,542 $ — $ 94,731 Liabilities: Deferred executive compensation liability — 6,458 — 6,458 Deferred drug development liability — — 14,686 14,686 Ligand Contingent Consideration — — 5,227 5,227 Talon CVR — — 1,377 1,377 Corixa Liability — — 62 62 $ — $ 6,458 $ 21,352 $ 27,810 December 31, 2014 Level 1 Level 2 Level 3 Total Assets: Bank certificates of deposits $ — $ 244 $ — $ 244 Money market currency funds — 66,945 — 66,945 Equity securities 7,191 — — 7,191 Mutual funds — 3,062 — 3,062 Deferred compensation investments, including life insurance cash surrender value — 6,958 — 6,958 $ 7,191 $ 77,209 $ — $ 84,400 Liabilities: Deferred executive compensation liability — 4,694 — 4,694 Deferred development liability — — 15,785 15,785 Ligand Contingent Consideration — — 4,901 4,901 Talon CVR — — 2,379 2,379 Corixa Liability — — 62 62 $ — $ 4,694 $ 23,127 $ 27,821 We did not have any transfers between Levels 1 and 2 for all periods presented. The following presents a roll forward of our liabilities for which we utilize Level 3 inputs in determining period-end value. These liabilities are included on our Consolidated Balance Sheets within “acquisition related contingent obligations” and “drug development liability”. The basis of the various Level 3 valuation inputs are discussed in the Notes to these accompanying Consolidated Financial Statements. Our carrying amounts of financial instruments such as cash equivalents, accounts receivable, prepaid expenses, accounts payable, and accrued liabilities, excluding acquisition related contingent consideration liabilities, approximate their related fair values due to their short-term nature. Fair Value Measurements of Level 3 ) Balance at December 31, 2013 $ 26,071 Deferred development costs (see Note 16) (1,957 ) Ligand Contingent Consideration (see Note 10(b)) 901 Talon CVR (see Note 10(a)) (1,950 ) Corixa Liability (see Note 17(b)(i)) 62 Balance at December 31, 2014 $ 23,127 Deferred development costs (see Note 16) (1,099 ) Ligand Contingent Consideration (see Note 10(b)) 326 Talon CVR (see Note 10(a)) (1,002 ) Corixa Liability (see Note 17(b)(i)) — Balance at December 31, 2015 $ 21,352 |
Business Combinations and Conti
Business Combinations and Contingent Consideration | 12 Months Ended |
Dec. 31, 2015 | |
Business Combinations [Abstract] | |
Business Combinations and Contingent Consideration | BUSINESS COMBINATIONS AND CONTINGENT CONSIDERATION (a) Acquisition of Talon Therapeutics, Inc. Talon Acquisition Overview On July 17, 2013 , we purchased all of the outstanding shares of common stock of Talon Therapeutics, Inc. (“Talon”). Through the acquisition of Talon, we gained worldwide rights to MARQIBO. The Talon purchase consideration comprised of (i) an aggregate upfront cash amount of $11.3 million , (ii) issuance of 3.0 million shares of our common stock, then equivalent to $26.3 million (based on a closing price of $8.77 per share on July 17, 2013), and (iii) the issuance of contingent value rights (“CVR”) initially valued at $6.5 million . The CVR was valued using a valuation model that probability-weights expected outcomes (ranging from 50% to 100% ) and discounts those amounts to their present value, using an appropriate discount rate (these represent unobservable inputs and are therefore classified as Level 3 inputs – see Note 2 (xiii) ). The CVR has a maximum payout of $195.0 million if all sales and regulatory approval milestones are achieved, as summarized below: • $5.0 million upon the achievement of net sales of MARQIBO in excess of $30.0 million in any calendar year • $10.0 million upon the achievement of net sales of MARQIBO in excess of $60.0 million in any calendar year • $25.0 million upon the achievement of net sales of MARQIBO in excess of $100.0 million in any calendar year • $50.0 million upon the achievement of net sales of MARQIBO in excess of $200.0 million in any calendar year • $100.0 million upon the achievement of net sales of MARQIBO in excess of $400.0 million in any calendar year • $5.0 million upon receipt of marketing authorization from the FDA regarding Menadione Topical Lotion Talon CVR Fair Value as of December 31, 2015 and December 31, 2014 The CVR fair value will continue to be evaluated on a quarterly basis. Current and future changes in its fair value results from the likelihood and timing of milestone achievement and/or the corresponding discount rate applied thereon. Adjustments to CVR fair value are recognized within “change in fair value of contingent consideration related to acquisitions” in the accompanying Consolidated Statements of Operations. Fair Value December 31, 2014 $ 2,379 Fair value adjustment for the year ended December 31, 2015 (1,002 ) December 31, 2015 $ 1,377 (b) Acquisition of Rights to EVOMELA and Related Contingent Consideration Overview of Acquisition of Rights to EVOMELA In March 2013, we completed the acquisition of exclusive global development and commercialization rights to Captisol-enabled ® , propylene glycol-free MELPHALAN (which we recently branded as “EVOMELA”) for use as a conditioning treatment prior to autologous stem cell transplant for patients with MM. We acquired these rights from CyDex Pharmaceuticals, Inc. a wholly-owned subsidiary of Ligand Pharmaceuticals Incorporated (“Ligand”) for an initial license fee of $3.0 million . We accounted for this transaction as a business combination, which requires that assets acquired and liabilities assumed be recognized on the balance sheet at their fair values as of the transaction date. We are required to pay Ligand additional amounts up to an aggregate $66.0 million , upon the achievement of certain regulatory milestones and net sales thresholds, and we also assumed full financial responsibility for its ongoing clinical and regulatory development program. We also must pay royalties of 20% on our future net sales of EVOMELA in all territories. Consideration Transferred The acquisition-date fair value of the consideration transferred consisted of the following: Cash consideration $ 3,000 Ligand Contingent Consideration 4,700 Total purchase consideration $ 7,700 Fair Value Estimate of Asset Acquired and Liability Assumed The total purchase consideration is allocated to the acquisition of the net tangible and intangible assets based on their estimated fair values as of the closing date. The allocation of the total purchase price to the net assets acquired is as follows: IPR&D EVOMELA rights $ 7,700 We estimated the fair value of the in-process research and development using the income approach. The income approach uses valuation techniques to convert future amounts to a single present amount (discounted). Our measurement is based on the value indicated by current market expectations about those future amounts. The fair value estimate took into account our estimates of future incremental earnings that may be achieved upon regulatory approval, promotion, and distribution associated with the rights, and included estimated cash flows of approximately 10 years and a discount rate of approximately 25% . The fair value of the contingent consideration liability assumed was determined using the probability of success and the discounted cash flow method of the income approach (representing unobservable inputs and therefore represent Level 3 values - see Note 2(xiii), which assumed that FDA approval of EVOMELA will occur on or about May 9, 2016 (on March 10, 2016, the FDA communicated its approval of this drug; however, under GAAP this event does not affect our reported liability estimate as of December 31, 2015). Upon receipt of FDA approval, we are contractually obligated to make a $6.0 million milestone payment to Ligand within 30 days ("Ligand Contingent Consideration"); accordingly, this payment is due no later than April 9, 2016. Ligand Contingent Consideration Fair Value as of December 31, 2015 and December 31, 2014 The Ligand Contingent Consideration fair value will continue to be evaluated on a quarterly basis. Any changes in its fair value results from the likelihood and timing of milestone achievement and/or the corresponding discount rate applied thereon. Adjustments to Ligand Contingent Consideration fair value are recognized within “change in fair value of the contingent consideration related to acquisitions” in the accompanying Consolidated Statements of Operations. Fair Value of December 31, 2014 $ 4,901 Fair value adjustment for year ended December 31, 2015 326 December 31, 2015 $ 5,227 (c) Allos Acquisition We acquired Allos Therapeutics, Inc. (“Allos”) on September 5, 2012, which was accounted for as a business combination. Our total cash consideration for this acquisition was $205.2 million , through which we acquired FOLOTYN distribution rights. We have no contingent consideration obligations as part of this transaction. |
Out-License of Marqibo, Zevalin
Out-License of Marqibo, Zevalin, & Evolmela in China Territory | 12 Months Ended |
Dec. 31, 2015 | |
Other Commitments [Abstract] | |
Out-License of Marqibo, Zevalin, & Evomela in China Territory | OUT-LICENSE OF MARQIBO, ZEVALIN, & EVOMELA IN CHINA TERRITORY Overview of CASI Out-License On September 17, 2014, we executed three product out-license agreements with a perpetual term (collectively, the “CASI Out-License”) with CASI Pharmaceuticals, Inc. (“CASI”), a publicly-traded biopharmaceutical company (NASDAQ: CASI) with a primary focus on the China market. Under the CASI Out-License, we granted CASI the exclusive rights to distribute two of our commercialized oncology drugs, ZEVALIN and MARQIBO, and our Phase 3 drug candidate, EVOMELA (“CASI Out-Licensed Products”) in greater China (which includes Taiwan, Hong Kong and Macau). In return, we received CASI equity for the rights related to ZEVALIN and EVOMELA and a secured promissory note for the rights related to MARQIBO. Additionally, under certain conditions which generally expire on September 17, 2019 , we have a right to receive additional CASI common stock in order to maintain our post-investment ownership percentage if CASI issues additional securities. CASI will be responsible for the development and commercialization of these three drugs, including the submission of import drug registration applications to regulatory authorities and conducting any confirmatory clinical studies in greater China. We will provide CASI with future commercial supply of the CASI Out-Licensed Products under typical market terms. Proceeds Received The proceeds we received, and its fair value on the CASI Out-License execution date, consisted of the following: CASI common stock (5.4 million shares) $ 8,649 (a) CASI secured promissory note due March 17, 2016 (since extended to March 17, 2017), net of fair value discount ($1.5 million face value and 0.5% annual coupon) 1,310 (b) Total consideration received, net of fair value discount $ 9,959 (c) (a) Value determined based on the September 17, 2014 closing price of 5.4 million shares of CASI common stock on the NASDAQ Capital Market of $1.60 per share. Our current intention is to hold these securities on a long-term basis. Accordingly, we have presented its value of $5.2 million as of December 31, 2015 within “other assets” (rather than “marketable securities”) on our accompanying Consolidated Balance Sheets. The change in the value of these securities is reported within “unrealized (loss) gain on available-for-sale securities” on the accompanying Consolidated Statement of Comprehensive Loss. (b) Value estimated using the terms of the $1.5 million promissory note, and the application of a synthetic debt rating based on CASI’s publicly-available financial information, and the prevailing interest yields on similar public debt securities as of September 17, 2014. The face value of the promissory note as of December 31, 2015 is included within "other assets" on the accompanying Consolidated Balance Sheets. (c) Presented within “license fees and service revenue” in the accompanying Consolidated Statement of Operations as of December 31, 2015 . In addition, CASI will be responsible for paying any royalties or milestones that we are obligated to pay to our third-party licensors resulting from the achievement of certain milestones and/or sales of CASI Out-Licensed Products, but only to the extent of the greater China portion of such royalties or milestones. Recognition of Proceeds – License Fee Revenue in 2015 The $9.7 million value (undiscounted, and net of certain foreign exchange adjustments) of the upfront proceeds that we received from CASI were recognized in the second quarter of 2015 within “license fees and service revenue” through our Consolidated Statements of Operations. The timing of this revenue recognition corresponds with the execution of supply agreements with CASI for ZEVALIN, MARQIBO, and EVOMELA. These agreements allow CASI to procure CASI Out-Licensed Products directly from approved third parties, and in such case, do not require our future involvement for their supply. |
Out-License of Zevalin in Certa
Out-License of Zevalin in Certain Ex-U.S. Territories | 12 Months Ended |
Dec. 31, 2015 | |
Other Commitments [Line Items] | |
Out-License of Zevalin in Certain Ex-U.S. Territories | OUT-LICENSE OF MARQIBO, ZEVALIN, & EVOMELA IN CHINA TERRITORY Overview of CASI Out-License On September 17, 2014, we executed three product out-license agreements with a perpetual term (collectively, the “CASI Out-License”) with CASI Pharmaceuticals, Inc. (“CASI”), a publicly-traded biopharmaceutical company (NASDAQ: CASI) with a primary focus on the China market. Under the CASI Out-License, we granted CASI the exclusive rights to distribute two of our commercialized oncology drugs, ZEVALIN and MARQIBO, and our Phase 3 drug candidate, EVOMELA (“CASI Out-Licensed Products”) in greater China (which includes Taiwan, Hong Kong and Macau). In return, we received CASI equity for the rights related to ZEVALIN and EVOMELA and a secured promissory note for the rights related to MARQIBO. Additionally, under certain conditions which generally expire on September 17, 2019 , we have a right to receive additional CASI common stock in order to maintain our post-investment ownership percentage if CASI issues additional securities. CASI will be responsible for the development and commercialization of these three drugs, including the submission of import drug registration applications to regulatory authorities and conducting any confirmatory clinical studies in greater China. We will provide CASI with future commercial supply of the CASI Out-Licensed Products under typical market terms. Proceeds Received The proceeds we received, and its fair value on the CASI Out-License execution date, consisted of the following: CASI common stock (5.4 million shares) $ 8,649 (a) CASI secured promissory note due March 17, 2016 (since extended to March 17, 2017), net of fair value discount ($1.5 million face value and 0.5% annual coupon) 1,310 (b) Total consideration received, net of fair value discount $ 9,959 (c) (a) Value determined based on the September 17, 2014 closing price of 5.4 million shares of CASI common stock on the NASDAQ Capital Market of $1.60 per share. Our current intention is to hold these securities on a long-term basis. Accordingly, we have presented its value of $5.2 million as of December 31, 2015 within “other assets” (rather than “marketable securities”) on our accompanying Consolidated Balance Sheets. The change in the value of these securities is reported within “unrealized (loss) gain on available-for-sale securities” on the accompanying Consolidated Statement of Comprehensive Loss. (b) Value estimated using the terms of the $1.5 million promissory note, and the application of a synthetic debt rating based on CASI’s publicly-available financial information, and the prevailing interest yields on similar public debt securities as of September 17, 2014. The face value of the promissory note as of December 31, 2015 is included within "other assets" on the accompanying Consolidated Balance Sheets. (c) Presented within “license fees and service revenue” in the accompanying Consolidated Statement of Operations as of December 31, 2015 . In addition, CASI will be responsible for paying any royalties or milestones that we are obligated to pay to our third-party licensors resulting from the achievement of certain milestones and/or sales of CASI Out-Licensed Products, but only to the extent of the greater China portion of such royalties or milestones. Recognition of Proceeds – License Fee Revenue in 2015 The $9.7 million value (undiscounted, and net of certain foreign exchange adjustments) of the upfront proceeds that we received from CASI were recognized in the second quarter of 2015 within “license fees and service revenue” through our Consolidated Statements of Operations. The timing of this revenue recognition corresponds with the execution of supply agreements with CASI for ZEVALIN, MARQIBO, and EVOMELA. These agreements allow CASI to procure CASI Out-Licensed Products directly from approved third parties, and in such case, do not require our future involvement for their supply. |
Mundipharma [Member] | |
Other Commitments [Line Items] | |
Out-License of Zevalin in Certain Ex-U.S. Territories | OUT-LICENSE OF ZEVALIN IN CERTAIN EX-U.S. TERRITORIES Out-License of ZEVALIN to Mundipharma On November 16, 2015, we entered into an out-license agreement with Mundipharma International Corporation Limited for their commercialization of ZEVALIN in Asia (excluding India and Greater China), Australia, New Zealand, Africa, the Middle East, and Latin America (including the Caribbean). In return, we received $18 million (comprised of $15 million received in December 2015 and $3 million received in January 2016), of which $15 million is included within "license fees and service revenue" on our accompanying Consolidated Statement of Operations. Revenue for the $3 million payment from January 2016 will be deferred and recognized within "license fees and service revenue" on a per unit basis with Mundipharma's future sales of ZEVALIN kits. We are also eligible to receive an additional $2 million upon Mundipharma's achievement of a specified sales milestone, that if/when achieved, will also be reported within "license fees and service revenue". In connection with this out-license, on November 16, 2015, we concurrently sold to Mundipharma K.K., all common stock of Spectrum Pharmaceuticals GK (the legal entity through which we previously sold ZEVALIN in Japan) for $2.2 million (in the form of an unsecured note, payable no later than May 2016), representing its net asset value (excluding inventory) as of November 16, 2015. |
Co-Promotion Arrangement With E
Co-Promotion Arrangement With Eagle Pharmaceuticals, Inc. | 12 Months Ended |
Dec. 31, 2015 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Co-promotion Arrangement With Eagle Pharmaceuticals, Inc. | CO-PROMOTION ARRANGEMENT WITH EAGLE PHARMACEUTICALS, INC. On November 4, 2015, we executed an agreement with Eagle Pharmaceuticals, Inc. ("Eagle") whereby designated members of our sales force will concurrently market up to six of Eagle's pharmaceutical products along with our products, in return for fixed monthly payments over the initial 18 month contract term through June 30, 2017, aggregating $12.8 million (the "Eagle Agreement"). We are also eligible to receive milestone payments of up to $5 million for sales made in 2016 that exceed certain thresholds, and up to $4 million for sales made in the first half 2017 that exceed certain thresholds. In addition, for performance above such sales thresholds in 2016, and in the first half of 2017, we are eligible to receive certain further payments if specified targets for annual net sales of Eagle's products are exceeded. The fixed payments to us, as well as costs for certain marketing activities that we coordinate with third parties, will be recognized within "license fees and service revenue" on our accompanying Consolidated Statement of Operations, beginning January 2016 (variable payments to us will be recognized in the period earned). An allocation of our corresponding sales personnel costs, and reimbursable costs for marketing activities will be recognized within a new caption on our Consolidated Statement of Operations, "cost of service revenue." Eagle may extend the initial term of this agreement by six months to December 31, 2017 at its sole election. Any extensions after December 31, 2017 require mutual consent and will be for six months per extension. The Eagle Agreement may be terminated by either party for uncured material breaches and certain other events following a change of control or insolvency of either party, and solely by Eagle for convenience with 60 days written notice, subject to an established termination fee, as calculated within the Eagle Agreement. |
Revolving Line of Credit
Revolving Line of Credit | 12 Months Ended |
Dec. 31, 2015 | |
Debt Disclosure [Abstract] | |
Revolving Line of Credit | REVOLVING LINE OF CREDIT We entered into a credit agreement on September 5, 2012 with Bank of America, N.A, as the administrative agent and Wells Fargo Bank, N.A, as an initial lender (the “Credit Agreement”). The Credit Agreement provided us with a committed $50 million revolving line of credit facility (the “Credit Facility”). The Credit Facility was repaid in full, then immediately terminated, on December 20, 2013 in connection with the sale and issuance of our 2018 Convertible Senior Notes (see Note 15 ). We recognized $1.2 million within “interest expense, net” in 2013, for this retired Credit Facility on the accompanying Consolidated Statement of Operations. |
Convertible Senior Notes
Convertible Senior Notes | 12 Months Ended |
Dec. 31, 2015 | |
Debt Disclosure [Abstract] | |
Convertible Senior Notes | CONVERTIBLE SENIOR NOTES Overview On December 17, 2013, we entered into an agreement for the sale of $120 million aggregate principal amount of 2.75% Convertible Senior Notes due December 2018 (the “2018 Convertible Notes”). The 2018 Convertible Notes are convertible into shares of our common stock at a conversion rate of 95 shares per $1,000 principal amount of the 2018 Convertible Notes, equating to 11.4 million common shares if fully converted. The in-the-money conversion price is equivalent to $10.53 per common share. The conversion rate and conversion price is subject to adjustment under certain limited circumstances. The 2018 Convertible Notes bear interest at a rate of 2.75% per year, payable semiannually in arrears on June 15 and December 15 of each year. The 2018 Convertible Notes will mature and become payable on December 15, 2018 , subject to earlier conversion into common stock at the holders’ option. The sale of the 2018 Convertible Notes closed on December 23, 2013 and our net proceeds were $115.4 million , after deducting banker and professional fees of $4.6 million . We used a portion of these net proceeds to simultaneously enter into “bought call” and “sold warrant” transactions with Royal Bank of Canada (collectively, the “Note Hedge”). We recorded the Note Hedge on a net cost basis of $13.1 million , as a reduction to “additional paid-in capital” in our accompanying Consolidated Balance Sheets. Under applicable GAAP, the Note Hedge transaction is not expected to be marked-to-market through earnings or comprehensive income in future reported periods. Conversion Hedge We entered into Note Hedge transactions to reduce the potential dilution to our stockholders and/or offset any cash payments that we are required to make in excess of the principal amount, upon conversion of the 2018 Convertible Notes (in the event that the market price of our common stock is greater than the conversion price). The strike price of the “bought call” is equal to the conversion price and conversion rate of the 2018 Convertible Notes, matching the 11.4 million common shares the 2018 Convertible Notes may be converted into. The strike price of our “sold warrant” is $14.03 per share of our common stock, and is also for 11.4 million common shares. Conversion Events On and after June 15, 2018, and until the close of business on the second scheduled trading day immediately preceding the maturity date, holders may convert all or a portion of their 2018 Convertible Notes. Prior to June 15, 2018, holders may convert all or a portion of their 2018 Convertible Notes only under any of the following circumstances: (1) during any fiscal quarter (and only during such fiscal quarter), if, for at least 20 trading days (whether or not consecutive) during the 30 consecutive trading day period ending on the last trading day of the immediately preceding fiscal quarter, the last reported sale price of our common stock on such trading day is greater than or equal to 130% of the applicable conversion price on such trading day; (2) during the five consecutive business day period immediately following any five consecutive trading day period in which, for each trading day of that measurement period, the trading price per $1,000 principal amount of 2018 Convertible Notes for such trading day was less than 98% of the product of (i) the last reported sale price of our common stock on such trading day and (ii) the applicable conversion rate on such trading day; (3) upon the occurrence of certain corporate transactions; and (4) at any time prior to our stockholders’ approval to settle the 2018 Convertible Notes in our common shares and/or cash. As of December 31, 2015 , the 2018 Convertible Notes are not eligible to be converted into common as none of the above elements (1) through (4) were met. Our stockholders’ approval of "flexible settlement" occurred at our Annual Meeting of Stockholders on June 29, 2015. As a result, we may (at our election) settle any future conversions of the 2018 Convertible Notes by paying or delivering cash, shares of common stock, or a combination of cash and shares of common stock. However, if the holders of the Convertible Notes do not elect any conversion into our common stock, our December 2018 obligation to repay the principal amount of $120 million in cash, plus any accrued and unpaid interest, is unchanged. Carrying Value and Fair Value The carrying value of the 2018 Convertible Notes as of December 31, 2015 is summarized as follows: Principal amount $ 120,000 (Less): Unamortized debt discount (amortized through December 2018) (18,452 ) December 31, 2015 $ 101,548 As of December 31, 2015 and December 31, 2014 , the estimated aggregate fair value of the 2018 Notes is $105.1 million and $113.2 million , respectively. These fair value estimates are less than the principal amount of $120 million , largely since the conversion feature of the 2018 Notes was, and remains, out-of-the money. These estimated fair values represent a Level 2 measurement (see Note 2(xiii) ), based upon the 2018 Convertible Notes' quoted bid price at each date in a thinly-traded market. Components of Interest Expense on 2018 Convertible Notes The following table sets forth the components of interest expense recognized in the accompanying Consolidated Statements of Operations for the 2018 Convertible Notes for the years ended December 31, 2015 and 2014 : Year Ended December 31, 2015 2014 Contractual coupon interest expense $ 3,300 $ 3,300 Amortization of debt issuance costs 662 599 Accretion of debt discount 5,250 4,818 Total $ 9,212 $ 8,717 Effective interest rate 8.66 % 8.66 % |
Mundipharma Agreement
Mundipharma Agreement | 12 Months Ended |
Dec. 31, 2015 | |
Other Liabilities Disclosure [Abstract] | |
Mundipharma Agreement | MUNDIPHARMA AGREEMENT As the result of our acquisition of Allos Therapeutics, Inc. on September 5, 2012 (through which we obtained distribution rights for FOLOTYN), we assumed its obligations under an active strategic collaboration agreement with a third-party, Mundipharma (the “Mundipharma Collaboration Agreement”). Under the Mundipharma Collaboration Agreement, we retained full commercialization rights for FOLOTYN in the U.S. and Canada, with Mundipharma having exclusive rights to commercialize FOLOTYN in all other countries in the world (the “Mundipharma Territories”). On May 29, 2013, the Mundipharma Collaboration Agreement was amended and restated (the “Amended Mundipharma Collaboration Agreement”), in order to modify: (i) the scope of the licensed territory, (ii) milestone payments, (iii) royalty rates, and (iv) drug development obligations. In connection with the Amended Mundipharma Collaboration Agreement, we received a one-time $7.0 million payment from Mundipharma for certain research and development activities to be performed by us. As a result of the Amended Mundipharma Collaboration Agreement, (a) Europe and Turkey were excluded from Mundipharma’s commercialization territory, (b) we may receive regulatory milestone payments of up to $16.0 million , and commercial progress and sales-dependent milestone payments of up to $107.0 million , (c) we will receive tiered double-digit royalties based on net sales of FOLOTYN within Mundipharma’s licensed territories, and (d) we and Mundipharma will bear our own FOLOTYN development costs. On May 29, 2015 and effective as of May 1, 2015, we entered into an amendment to the Amended Mundipharma Collaboration Agreement (the “Amendment”). Pursuant to the Amendment, among other things, the parties revised the conditions to our exercise of the option to gain commercialization rights in Switzerland from Mundipharma, and also revised tiered double digit royalties payable by Mundipharma on net sales in Switzerland. The fair value of this liability is included in the current and long-term portions of “drug development liability” within the accompanying Consolidated Balance Sheets, and it includes our assumptions about personnel needed to perform these research and development activities, third party costs for projected clinical trial enrollment, and patient treatment-related follow up through approximately 2031. The fair value of our “drug development liability” within our accompanying Consolidated Balance Sheets was estimated using the discounted income approach model. The unobservable inputs (i.e., Level 3 inputs - see Note 2(xiii) ) in this valuation model that have the most significant effect on these liabilities include (i) estimates of research and development personnel costs needed to perform the research and development services, (ii) estimates of expected cash outflows to third parties for services and supplies during the expected period of performance through 2031, and (iii) an appropriate discount rate for these expenditures. These inputs are reviewed by management on a quarterly basis for continued applicability. We assess this liability at each reporting date and record its adjustment through “research and development” expense in our accompanying Consolidated Statements of Operations. Year Ended December 31, Drug Drug Total Drug Balance at December 31, 2014 $ 1,141 $ 14,644 $ 15,785 Transfer from long term to current in 2015 217 (217 ) — (Less): Expenses incurred in 2015 (1,099 ) — (1,099 ) Balance at December 31, 2015 $ 259 $ 14,427 $ 14,686 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2015 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | COMMITMENTS AND CONTINGENCIES (a) Facility and Equipment Leases We lease our principal executive office in Henderson, Nevada under a non-cancelable operating lease expiring April 30, 2019 . We also lease our research and development and administrative facility in Irvine, California under a non-cancelable operating lease expiring May 31, 2019 , in addition to several other administrative office leases. Each lease agreement contains scheduled rent increases which are accounted for on a straight-line basis. Our total rental expense in 2015 , 2014 , and 2013 was $1.7 million , $1.9 million , and $1.2 million , respectively. Our future minimum lease payments are as follows: Year ending December 31, Operating Lease 2016 $ 1,283 2017 1,172 2018 1,209 2019 460 2020 — $ 4,124 (b) Licensing Agreements, Co-Development Agreements and Milestone Payments Our drug candidates are being developed pursuant to license agreements that provide us with territory-specific rights to its manufacture, sublicense, and sale. We are generally responsible for all development costs, patent filings and maintenance costs, sales and marketing costs, and liability insurance costs. We are also obligated to make certain milestone payments to third parties upon the achievement of regulatory and sales milestones that are specified in these license agreements. We estimate and present a corresponding liability on our Consolidated Balance Sheets when amounts are probable and reasonably estimable. In addition, we are obligated to pay royalties based on our current and future net sales of in-licensed products. Our most significant of these agreements are listed and summarized below: (i) ZEVALIN U.S.: In-Licensing and development in the U.S. In December 2008, we acquired rights to commercialize and develop ZEVALIN in the U.S. as the result of a transaction with Cell Therapeutics, Inc. (“CTI”) through our wholly-owned subsidiary, RIT Oncology LLC (“RIT”). We assumed certain agreements with various third parties related to ZEVALIN intellectual property for its manufacture, use, and sale in the U.S. In accordance with the terms of assumed contracts, we are required to meet specified payment obligations, including a milestone payment to Corixa Corporation of $5.0 million based on ZEVALIN sales in the U.S. (the “Corixa Liability”). This milestone has not yet been met, and $0.1 million for this potential milestone achievement is included within “acquisition-related contingent obligations” in our accompanying Consolidated Balance Sheet as of December 31, 2015 and December 31, 2014 , respectively. Our U.S. net sales-based royalties are in the low to mid-single digits to Genentech, Inc. and mid-teens to Biogen. (ii) ZEVALIN Ex-U.S.: In-License and Asset Purchase Agreement with Bayer Pharma In April 2012, through our wholly-owned subsidiary, Spectrum Pharmaceuticals Cayman, L.P., we completed the acquisition of licensing rights to market ZEVALIN outside of the U.S. from Bayer Pharma AG (“Bayer”). ZEVALIN is currently approved in approximately 40 countries outside the U.S. for the treatment of B-cell non-Hodgkin lymphoma, including countries in Europe, Latin America and Asia. In consideration for the rights granted under the agreement, concurrent with the closing, we paid Bayer a one-time fee of €19.0 million . Our ex-U.S. net sales-based royalty to Bayer ranges between the single digits to mid-teens. Unless earlier terminated, the term of the agreement continues until the expiration of the last-to-expire patent covering the sale of a licensed product in the relevant country, or 15 years from the date of first commercial sale of the licensed product in such country, whichever is longer. (iii) ZEVALIN Ex-U.S.: Out-License Agreement with Dr. Reddy’s Effective June 27, 2014, we executed an exclusive License Agreement with Dr. Reddy’s Laboratories Ltd. (“Dr. Reddy’s”), for the distribution rights of ZEVALIN within India. The agreement term is 15 years from the receipt of pending approval of ZEVALIN from the Drug Controller General of India. On December 17, 2014, upon the execution of a supply agreement, an upfront and non-refundable payment of $0.5 million was triggered and was paid to us in February 2015. This recognition of this upfront payment is reported on a straight line basis, within “license fee and service revenue” on the Consolidated Statement of Operations over a 10 -year term through December 2024. Additionally, sales and regulatory milestones (aggregating $3 million ) will become payable to us when achieved by Dr. Reddy’s, as well as a 20% royalty on net sales of ZEVALIN in India. (iv) FUSILEV: Amended and Restated In-License Agreement with Merck & Cie AG In May 2006, we amended and restated a license agreement with Merck & Cie AG (“Merck”), which we assumed in connection with our March 2006 acquisition of the assets of Targent, Inc. Pursuant to the license agreement with Merck, we obtained the exclusive license to use regulatory filings related to FUSILEV and a non-exclusive license under certain patents and know-how to develop, manufacture, use, and sell FUSILEV in the field of oncology in North America in return for a royalty percentage (in the mid-single digits) of net sales. Merck is eligible to receive a $0.2 million payment from us upon the achievement of a FDA approval of an oral form of FUSILEV. This milestone has not yet been met, and no amounts have been accrued in our accompanying Consolidated Balance Sheets for its potential achievement. (v) FOLOTYN: In-License Agreement with Sloan-Kettering Institute, SRI International and Southern Research Institute In December 2002, Allos entered into the FOLOTYN License Agreement with Sloan-Kettering Institute for Cancer Research, SRI International, and Southern Research Institute. As a result of Allos becoming our wholly owned subsidiary in September 2012, we are bound by the FOLOTYN License Agreement under which we obtained exclusive worldwide rights to a portfolio of patents and patent applications related to FOLOTYN and its uses. Under the terms of the FOLOTYN License Agreement, we are required to fund all development programs and have sole responsibility for all commercialization activities. In addition, we pay graduated royalties to our licensors based on our (including sub licensees) worldwide annual net sales of FOLOTYN. Royalties are 8% of annual worldwide net sales up to $150 million ; 9% of annual worldwide net sales of $150 million through $300 million ; and 11% of annual worldwide net sales in excess of $300 million . (vi) EVOMELA: In-License Agreement with Cydex Pharmaceuticals, Inc. In March 2013, we completed the acquisition of exclusive global development and commercialization rights to EVOMELA from Ligand (see Note 10(b) ). We filed an NDA with the FDA in December 2015 for its use as a conditioning treatment prior to autologous stem cell transplant for patients with MM. On March 10, 2016, the FDA communicated its approval of our NDA for EVOMELA. Upon receipt of FDA approval, we are contractually obligated to make a $6.0 million milestone payment to Ligand within 30 days ("Ligand Contingent Consideration"); accordingly, this payment is due no later than April 9, 2016. We are required to pay Ligand amounts of up to $66 million (inclusive of the $6.0 million milestone for FDA approval), upon achievement of certain regulatory milestones and net sales thresholds, which we have valued at $5.2 million and $4.9 million within “acquisition-related contingent obligations” in our accompanying Consolidated Balance Sheets as of December 31, 2015 and December 31, 2014 , respectively. We will also pay royalties of 20% on our net sales of licensed products in all territories. (vii) MARQIBO: Contingent Consideration Agreement with Talon Therapeutics, Inc. In July 2013, we completed the acquisition of Talon, through which we obtained exclusive global development and commercialization rights to MARQIBO (see Note 10(a) ). As part of this acquisition, we issued the former Talon stockholders contingent value rights (“CVR”) that we have valued and presented on our accompanying Consolidated Balance Sheets as a $1.4 million and $2.4 million liability within “acquisition-related contingent obligations” as of December 31, 2015 and December 31, 2014 , respectively. The CVR has a maximum payout value of $195 million if all sales and regulatory approval milestones are achieved. (viii) EOQUIN (previously referred to as APAZIQUONE): License Agreement with Allergan, Inc. and NDDO Research Foundation In October 2008, we entered into an exclusive development and commercialization collaboration agreement with Allergan for EOQUIN. Pursuant to the terms of the agreement, Allergan paid us an up-front non-refundable fee of $41.5 million at closing (which we have amortized through revenue within “license fees and service revenue” in full as of December 31, 2013). In October 2008, pursuant to a letter agreement with NDDO Research Foundation (“NDDO”), we agreed to pay NDDO the following in relation to EOQUIN milestones: (a) upon FDA acceptance of the NDA, the issuance of 25,000 of our common shares and (b) upon FDA approval of the drug (its target decision date is set for December 11, 2016), a one-time payment of $0.3 million . In January 2013, we entered into a second amendment to the license, development, supply and distribution agreement with Allergan to amend the agreement and reacquire the rights originally licensed to Allergan in the U.S., Europe, and other territories in exchange for a tiered single-digit royalty on net sales of certain products containing EOQUIN, and relieved Allergan of its development and commercialization obligations. (ix) EOQUIN: Collaboration Agreement with Nippon Kayaku Co. LTD. In November 2009, we entered into a collaboration agreement with Nippon Kayaku Co., LTD. (“Nippon Kayaku”) for the development and commercialization of EOQUIN in Asia, except North and South Korea (the “Nippon Kayaku Territory”). In addition, Nippon Kayaku received exclusive rights to EOQUIN for the treatment of non-muscle invasive bladder cancer in Asia (other than North and South Korea), including Japan and China. Nippon Kayaku will conduct EOQUIN clinical trials in the Nippon Kayaku Territory pursuant to a development plan. Further, Nippon Kayaku will be responsible for all expenses relating to the development and commercialization of EOQUIN in the Nippon Kayaku Territory. Under the terms of this agreement, Nippon Kayaku paid us an upfront fee of $15 million (which we have amortized through revenue within “license fees and service revenue” in full as of December 31, 2013). Nippon Kayaku is also obligated to make additional payments to us based on the achievement of certain development, regulatory and commercialization milestones. Under the terms of the agreement, we are entitled to payment of $10 million and $126 million upon achievement of certain regulatory and commercialization milestones, respectively. Also, Nippon Kayaku has agreed to pay us royalties based on a percentage of net sales of the subject products in the defined territory in the mid-teen digits. (x) BELEODAQ: In-Licensing and Collaboration Agreement with TopoTarget In February 2010, we entered into a licensing and collaboration agreement with TopoTarget A/S (now Onxeo SA) (“TopoTarget”), as amended in October 2013, for the development and commercialization of BELEODAQ. The agreement provides that we have the exclusive right to manufacture, develop, and commercialize BELEODAQ in North America and India, with an option for China. Pursuant to the terms of this agreement, we paid TopoTarget an upfront fee of $30 million in 2010. Under continuing terms, all development, including studies, will be conducted under a joint development plan, which we will fund 70% of such costs, and TopoTarget will fund 30% . We have final decision-making authority for all developmental activities in North America and India (and China upon exercise of our option). TopoTarget has final decision-making authority for all developmental activities in all other jurisdictions. In February 2014, upon FDA acceptance of our new drug application, we issued one million shares of our common stock, and made a $10 million milestone payment to TopoTarget. The aggregate payout value of this first milestone at achievement was $17.8 million , and is recognized within “research and development” of the accompanying Consolidated Statement of Operations during the first quarter of 2014. In July 2014, we received approval from the FDA for BELEODAQ’s use for injection and treatment of relapsed or refractory PTCL. As a result, we paid a second milestone payment to TopoTarget of $25 million in November 2014, which we capitalized as an amortizable intangible asset. Other potential milestone payments due upon BELEODAQ regulatory achievements and sales thresholds (aggregating $278 million ) are not included within “total liabilities” in our accompanying Consolidated Balance Sheets. We will pay TopoTarget future royalties in the mid-teen digits based on our net sales of BELEODAQ. The agreement will continue until the expiration of the last royalty payment period in the last country in the defined territory with certain provisions surviving, unless earlier terminated in accordance with its terms. (xi) SPI-2012: Co-Development and Commercialization Agreement with Hanmi Pharmaceutical Company In January 2012 (and as amended in March 2014 and October 2014), we entered into a License, Development and Supply Agreement with Hanmi Pharmaceutical Co., Ltd. (“Hanmi”), for SPI-2012, formerly known as “LAPS-GCSF”, a drug based on Hanmi’s proprietary LAPSCOVERY™ technology for the treatment of chemotherapy induced neutropenia. Under the terms of the agreement, as amended, we have primary financial responsibility for the SPI-2012 development plan. We have worldwide rights for SPI-2012, except for Korea, China, and Japan. We will also be responsible for milestone payments related to SPI-2012 Phase 3 clinical trial commencement (resulting in a triggered $3 million milestone payment, based on initial patient dosing in January 2016; we intend to settle this liability through the issuance of our stock to Hanmi by March 2016), regulatory approvals, and sales thresholds (aggregating $238 million ), which are not included within “total liabilities” in our accompanying Consolidated Balance Sheets. We will pay Hanmi royalties in the mid-teen digits on our net sales of SPI-2012. (xii) POZIOTINIB: In-License Agreement with Hanmi In February 2015, we executed an in-license agreement with Hanmi Pharmaceutical Co., Ltd for POZIOTINIB, a pan-HER inhibitor in Phase 2 clinical trials, requiring our upfront payment for these rights. This drug has shown single agent activity in the treatment of various cancer types during Phase I studies, including breast, gastric, colorectal and lung cancers. Under the terms of this agreement, we received the exclusive rights to commercialize POZIOTINIB, excluding Korea and China. Hanmi, and its development partners, will bear full responsibility for the on-going Phase 2 trials in Korea. We will bear full financial responsibility for all other clinical studies. We will pay Hanmi future regulatory and sales-dependent milestones (aggregating $358 million ), which are not included within “total liabilities” in our accompanying Consolidated Balance Sheets. We will pay Hanmi royalties in the low to mid-teen digits on our net sales of POZIOTINIB. (c) Service Agreements In connection with the research and development of our drug products, we have entered into contracts with numerous third party service providers, such as radio-pharmacies, distributors, clinical trial centers, clinical research organizations, data monitoring centers, and with drug formulation, development and testing laboratories. The financial terms of these agreements are varied and generally obligate us to pay in stages, depending on achievement of certain events specified in the agreements, such as contract execution, reservation of service or production capacity, actual performance of service, or the successful accrual and dosing of patients. At each period end, we accrue for all services received, with such accruals based on factors such as estimates of work performed, patient enrollment, completion of patient studies and other events. Should we decide to discontinue and/or slow-down the work on any project, the associated costs for those projects would be limited to the extent of the work completed. Generally, we are able to terminate these contracts due to the discontinuance of the related project(s) and thus avoid paying for the services that have not yet been rendered. (d) Supply Agreements We have entered into certain supply agreements, or have issued purchase orders, which require us to make minimum purchases from vendors for the manufacture of our products. These commitments do not exceed our planned commercial requirements, and the contracted prices do not exceed their fair market value. (e) Employment Agreements We have entered into an employment agreement with our Chief Executive Officer under which cash compensation and benefits would become payable in the event of termination by us for any reason other than cause, his resignation for good reason, or upon a change in control of our Company. (f) Deferred Compensation Plan The Spectrum Pharmaceuticals, Inc. Deferred Compensation Plan (the “DC Plan”) is administered by the Compensation Committee of our Board of Directors and is intended to comply with the requirements of Section 409A of the Internal Revenue Code of 1986, as amended. The DC Plan is maintained to provide deferred compensation benefits for a select group of our employees (the “DC Participants”). Under the DC Plan, we provide the DC Participants with the opportunity to make annual elections to defer up to a specified amount or percentage of their eligible cash compensation, and we have the option to make discretionary contributions. At December 31, 2015 and December 31, 2014 , this DC Plan liability was $6.5 million and $4.7 million , respectively, and is included within “other long-term liabilities” in the accompanying Consolidated Balance Sheets. (g) Litigation We are involved from time-to-time with various legal matters arising in the ordinary course of business. These claims and legal proceedings are of a nature we believe are normal and incidental to a pharmaceutical business, and may include product liability, intellectual property, employment matters, and other general claims. We make provisions for liabilities when it is both probable that a liability has been incurred and the amount of the loss can be reasonably estimated. Such provisions are assessed at least quarterly and adjusted to reflect the impact of any settlement negotiations, judicial and administrative rulings, advice of legal counsel, and other information and events pertaining to a particular case. Litigation is inherently unpredictable. Although the ultimate resolution of these various matters cannot be determined at this time, we do not believe that such matters, individually or in the aggregate, will have a material adverse effect on our consolidated results of operations, cash flows, or financial condition. We are presently responding to ANDAs filed by companies seeking to market generic forms of FOLOTYN. We are also responding to certain stockholder suits that purportedly stem from our March 12, 2013 press release, in which we announced anticipated changes in customer ordering patterns of FUSILEV. These complaints allege that, as a result of this press release, our stock price declined. FUSILEV ANDA Litigation On January 20, 2012, March 2, 2012, June 18, 2014, January 23, 2015, July 17, 2015 and September 3, 2015 respectively, we filed suit against Sandoz Inc., Innopharma Inc., Ben Venue Laboratories, Inc., Amneal Pharmaceuticals, Inc., and Actavis LLC. respectively, following Paragraph IV certifications in connection with their filing separate ANDAs, to manufacture a generic version of FUSILEV. We filed the lawsuits in the U.S. District Court for the Districts of Nevada and Delaware seeking to enjoin the approval of their ANDAs plus recovery of our litigation fees and costs incurred in such matters. On December 9, 2013, three Mylan entities collaborating with Innopharma were joined to Innopharma case. On November 24, 2014, the complaint in the Ben Venue case was amended to substitute the original defendant Ben Venue Laboratories, Inc. with successors West-Ward Pharmaceutical Corp. and Eurohealth International SARL. A trial took place in the Sandoz case from January 12, 2015 through January 20, 2015 in the U.S. District Court for the District of Nevada and on February 20, 2015 the district court found certain of the asserted claims of the patent covering FUSILEV invalid. On February 27, 2015, we filed our Notice of Appeal. On August 4, 2015 the Delaware district court ordered that judgment be entered for Innopharma and Mylan due to the Nevada district court judgment in the Sandoz action. On October 2, 2015, the U.S. Court of Appeals for the Federal Circuit affirmed the previously reported judgment from the U.S. District Court for the District of Nevada in favor of Sandoz Inc. On April 27, 2015, we filed suit in the U.S. District Court for the District of Columbia against the FDA seeking a temporary restraining order or preliminary injunction to suspend FDA approval of Sandoz’s ANDA. The Company contends that Sandoz’s ANDA should not have been approved until the expiry of the Company’s Orphan Drug Exclusivity on April 29, 2018. On April 29, 2015, the court denied the temporary restraining order and on May 27, 2015, the court entered summary judgment in favor of the FDA et al. On June 5, 2015, we filed our Notice of Appeal. Oral argument was held October 22, 2015. The ultimate outcome of this proceeding is uncertain. FOLOTYN ANDA Litigation On June 19, 2014, we filed a lawsuit against five parties resulting from Paragraph IV certifications in connection with four separate ANDAs to manufacture a generic version of FOLOTYN: (1)Teva Pharmaceuticals USA, Inc., (2) Sandoz Inc., (3) Fresenius Kabi USA, LLC, (4) Dr. Reddy’s Laboratories, Ltd., and (5) Dr. Reddy’s Laboratories, Inc. We filed the lawsuit in the U.S. District Court for the District of Delaware seeking to enjoin the approval of their ANDAs plus recovery of our litigation fees and costs. The litigation is stayed with respect to the Dr. Reddy's entities pending resolution of the case against the other FOLOTYN ANDA filers. A trial date of September 12, 2016 has been set in the FOLOTYN lawsuit in the U.S. District Court for the District of Delaware. While we believe our patent rights are strong, the ultimate outcome of such action is uncertain. Stockholder Litigation John Perry v. Spectrum Pharmaceuticals, Inc. et al. (Filed March 14, 2013 in United States District Court, District of Nevada; Case Number 2:2013-cv-00433-LDG-CWH). This putative consolidated class action raises substantially identical claims and allegations against defendants Spectrum Pharmaceuticals, Inc., Dr. Rajesh C. Shrotriya, Brett L. Scott, and Joseph Kenneth Keller. The alleged class period is August 8, 2012 to March 12, 2013. The lawsuits allege a violation of Section 10(b) of the Securities Exchange Act of 1934 against all defendants and control person liability, as a violation of Section 20(b) of the Securities Exchange Act of 1934, against the individual defendants. The claims purportedly stem from the Company’s March 12, 2013 press release, in which it announced that it anticipated a change in ordering patterns of FUSILEV. The complaints allege that, as a result of the March 12, 2013 press release, the Company’s stock price declined. The complaints further allege that during the putative class period certain defendants made misleadingly optimistic statements about FUSILEV sales, which inflated the trading price of Company stock. The lawsuits seek relief in the form of monetary damages, costs and fees, and any other equitable or injunctive relief that the court deems appropriate. On March 21, 2014, the Court entered an order appointing Arkansas Teacher Retirement System as lead plaintiff. On May 20, 2014, Arkansas Teacher Retirement System filed a consolidated amended class action complaint. On July 18, 2014, we filed a motion to dismiss the consolidated amended class action complaint. On March 26, 2015, the court denied the motion to dismiss. On June 15, 2015, the Court ordered a stay of the proceedings pending the outcome of mediation between the parties. On October 27, 2015, we reached a $7 million settlement in principle with the lead plaintiff (which involved our insurance carrier, as the reimbursing party in full), subject to preliminary and final court approval. We have included this settlement amount, along with $0.1 million of reimbursable legal expenses for this matter, on our accompanying Consolidated Balance Sheets as of December 31, 2015 within "other receivables" and "accounts payable and other accrued liabilities." On January 26, 2016, the Court preliminarily approved the settlement. The Court has scheduled a hearing on final approval of the settlement for June 13, 2016. Timothy Fik v. Rajesh C. Shrotriya, et al. (Filed April 11, 2013 in United States District Court, District of Nevada; Case Number 2:2013-cv-00624-JCM-CWH); Christopher J. Watkins v. Rajesh C. Shrotriya, et al. (Filed April 22, 2013 in United States District Court, District of Nevada; Case Number 2:2013-cv-00684-JCM-VCF); and Stefan Muenchhagen v. Rajesh C. Shrotriya, et al. (Filed May 28, 2013; Case Number 2:2013-cv-00942-APG-PAL). These derivative complaints are brought by the respective purported stockholders on behalf of nominal plaintiff Spectrum against certain current and former directors and officers. The complaints generally allege breaches of fiduciary based on conduct relating to the events alleged in the consolidated Perry action. The complaints seek compensatory damages, corporate governance reforms, restitution and disgorgement of defendants’ alleged profits, and costs and fees. These actions are stayed pending resolution of the federal securities class action. Settlement discussions are ongoing, and accordingly, no agreement has yet been reached to resolve these derivative complaints. If a settlement were reached, we believe it would be reimbursable by our insurance carrier. However, the value of a potential settlement cannot be reasonably estimated given its highly uncertain nature. Hardik Kakadia v. Rajesh C. Shrotriya, et al. (Filed April 23, 2013 in the Eighth Judicial District Court of the State of Nevada in and for Clark County; Case Number A-13-680643-B); and Joel Besner v. Rajesh C. Shrotriya, et al. (Filed May 31, 2013; Case Number A-13-682668-C) (collectively the “State Derivative Actions”). These consolidated State Derivative Actions are brought by the respective purported stockholders on behalf of nominal plaintiff Spectrum Pharmaceuticals, Inc. and are substantially similar to the consolidated federal derivative actions. These actions are stayed pending resolution of the federal securities class action. Settlement discussions are ongoing, and accordingly, no agreement has yet been reached to resolve these derivative complaints. If a settlement were reached, it would be reimbursable by our insurance carrier. However, the value of a potential settlement cannot be reasonably estimated given its highly uncertain nature. Ira Gains v. Spectrum Pharmaceuticals, Inc. and Rajesh C. Shrotriya was filed in the United States District Court, District of Nevada on November 3, 2015. This putative class action was brought against defendants Spectrum Pharmaceuticals, Inc., and Dr. Rajesh C. Shrotriya. The alleged class period was May 7, 2015 to October 23, 2015. The complaint alleged a violation of Section 10(b) of the Securities Exchange Act of 1934 against all defendants and control person liability, as a violation of Section 20(a) of the Securities Exchange Act of 1934, against Dr. Rajesh C. Shrotriya. The claims purportedly stemmed from our October 23, 2015 press release in which we announced that the FDA issued a Complete Response Letter indicating that the FDA would not approve our NDA for EVOMELA in its present form. The complaint alleged that, as a result of the October 23, 2015 press release, our stock price declined. The complaint further alleged that during the putative class period defendants made misleadingly optimistic statements about the progress of the NDA for EVOMELA with the FDA, our expectations regarding FDA approval of the NDA, and EVOMELA’s potential as a future driver of our revenue, which inflated the trading price of our stock. The complaint sought relief in the form of monetary damages, costs and fees, and any other relief that the Court deemed appropriate. On December 11, 2015, plaintiff voluntarily dismissed the action without prejudice. (h) SEC Subpoena On April 1, 2013, we received a subpoena from the SEC for documents pursuant to a formal order of investigation. The subpoena followed our March 12, 2013 announcement that we anticipated a change in customer ordering patterns of FUSILEV. We have cooperated with the SEC throughout its investigation, and on November 30, 2015, we received a notice from that the SEC does not intend to recommend an enforcement action against our company. (i) Notice from HRSA We received a notice on October 10, 2014 from the U.S. Health Resources and Services Administration, Office of Pharmacy Affairs (“HRSA”). In this notice HRSA asserted that, for at least one of our products with an “orphan drug” designation under section 526 of the Federal Food, Drug, and Cosmetic Act, we did not make the product(s) available for purchase by certain categories of providers at the applicable 340B price. The 340B price is a discounted price for covered outpatient drugs that manufacturers participating in Medicaid (which includes us) agree to make available to providers that participate in the 340B drug pricing program (“Covered Entities”). HRSA’s notice asserted that, by not selling our product(s) to certain categories of Covered Entities at 340B prices, we were overcharging them, and that we owed certain undefined refunds to those Covered Entities based on our previously made and reported product sales. On October 14, 2015, the U.S. District Court for the District of Columbia issued a decision in the case of Pharmaceutical Research and Manufacturers of America v. United States Department of Health and Human Services, et al., invalidating HRSA’s July 21, 2014 “interpretive rule” relating to orphan drug pricing under the 340B drug pricing program. Because HRSA’s October 10, 2014 notice to us reflected the same interpretation of relevant orphan drug pricing statutes as the interpretation overturned by the District Court in the Pharmaceutical Research and Manufacturers of America decision, we believe the decision supports the propriety of our pricing to Covered Entities. Since we only make provisions for liabilities when it is both probable that a liability has been incurred, and the amount can be reasonably estimated, we have not recorded a liability for this pending matter as of December 31, 2015 or any earlier period. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2015 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | INCOME TAXES The components of loss before provision for income taxes are as follows: For the Years Ended 2015 2014 2013 United States $ (56,554 ) $ (37,327 ) $ (30,437 ) Foreign 6,175 (6,205 ) (6,199 ) Total $ (50,379 ) $ (43,532 ) $ (36,636 ) The provision for income taxes consist of the following: For the Years Ended 2015 2014 2013 Current: Federal $ 113 $ 1,529 $ (8,357 ) State 5 126 (691 ) Foreign 148 29 — $ 266 $ 1,684 $ (9,048 ) Deferred: Federal 114 495 36,183 State 26 7 (1,637 ) Foreign — — — 140 502 34,546 Total income tax provision $ 406 $ 2,186 $ 25,498 The 2014 income tax provision includes $1.5 million related to the correction of our prior year estimates of carryback of federal net operating losses, book tax differences on acquisition-related liabilities, and credits ineligible for offset against federal income taxes. Management has evaluated the materiality of these adjustments quantitatively and qualitatively, and has concluded that the corrections are immaterial to the accompanying Consolidated Financial Statements, taken as a whole. The income tax provision differs from that computed using the federal statutory rate applied to income before taxes as follows: 2015 2014 2013 Tax provision computed at the federal statutory rate $ (17,619 ) $ (15,236 ) $ (12,822 ) State tax, net of federal benefit 232 66 (246 ) Research credits (2,974 ) (2,134 ) (2,254 ) FIN 48 uncertain tax positions — — — Change in tax credit carryforwards (4,965 ) — — Transaction costs — (11 ) 880 Officers compensation 1,577 1,895 2,178 Stock based compensation 535 299 501 Permanent items and other (487 ) 21,742 (1,080 ) Domestic manufacturing deduction — (630 ) 767 Tax differential on foreign earnings 1,435 1,570 1,123 Change in tax rate (903 ) (519 ) (283 ) Valuation allowance 23,575 (4,856 ) 36,734 Income tax provision $ 406 $ 2,186 $ 25,498 The Protecting Americans from Tax Hikes Act of 2015, which President Obama signed into law on December 18, 2015, reinstated the research and development credit for 2015 and included a permanent extension of the research credit under Section 41. We recorded a $0.4 million benefit, before impact of valuation allowance, related to the research and development credit in 2015. Significant components of our deferred tax assets as of December 31, 2015 and 2014 are presented below. A valuation allowance has been recognized to offset the net deferred tax assets as realization of such deferred tax assets no longer meets the “more-likely-than-not” threshold under GAAP. 2015 2014 Deferred tax assets: Net operating loss carry forwards $ 41,251 $ 40,505 Research credits 22,082 9,045 Stock based compensation 4,828 3,703 Deferred revenue 2,280 1,893 Development costs 5,504 5,950 Returns and allowances 1,363 4,161 Other, net 9,887 9,082 Total deferred tax assets before valuation allowance 87,195 74,339 Valuation allowance (71,815 ) (45,983 ) Total deferred tax assets 15,380 28,356 Deferred tax liabilities: Basis difference in debt (713 ) (907 ) Depreciation and amortization differences (21,446 ) (34,088 ) Net deferred tax liability $ (6,779 ) $ (6,639 ) At December 31, 2015 and 2014 , we recorded a valuation allowance of $71.8 million and $46.0 million , respectively. The valuation allowance increased by $25.8 million and decreased by $3.6 million , during 2015 and 2014 , respectively. The increase in the valuation allowance in 2015 was due to increased research & development and orphan drug credits and the decrease in deferred tax liabilities. The decrease in valuation allowance in 2014 was due to a $17.2 million adjustment to write off deferred tax assets acquired from Talon that were determined not to be realizable. At December 31, 2015 , we had federal and state net operating loss carryforwards of approximately $111.5 million and $92.7 million , respectively. We have approximately $8.9 million of foreign loss carryforwards that will begin to expire in 2022 . The federal and state loss carry forwards will begin to expire in 2018 and 2016, respectively, unless previously utilized. At December 31, 2015 , we had federal and state tax credits of approximately $22.9 million and $3.0 million , respectively. The federal tax credit carryovers begin to expire in 2027 unless previously utilized. The state research and development credit carryforwards have an indefinite carryover period. As a result of the prior ownership changes, the utilization of certain net operating loss and research and development tax credit carryforwards including those acquired in connection with the acquisition of Allos and Talon are subject to annual limitations under Sections 382 and 383 of the Internal Revenue Code of 1986 and similar state provisions. Any net operating losses or credits that would expire unutilized as a result of Section 382 and 383 limitations have been removed from the table of deferred tax assets and the accompanying disclosures of net operating loss and research and development carryforwards. Accounting guidance clarifies the accounting for uncertain tax positions and prescribes a recognition threshold and measurement process for recording in the financial statements uncertain tax positions taken or expected to be taken in a tax return. Additionally, the authoritative guidance addresses the de-recognition, classification, accounting in interim periods and disclosure requirements for uncertain tax positions. Only tax positions that meet the more-likely-than-not recognition threshold at the effective date may be recognized. In November 2015, the FASB issued ASU 2015-17, Balance Sheet Classification of Deferred Taxes , which requires companies to classify all deferred tax assets and liabilities as noncurrent on the balance sheet instead of separating deferred taxes into current and noncurrent amounts by jurisdiction. For public business entities, the guidance is effective for financial statements issued for annual periods beginning after December 15, 2016. We decided to early adopt these provision on a prospective basis as of December 31, 2015, and the adoption did not have a material impact on the accompanying Consolidated Financial Statements. The following tabular reconciliation summarizes activity related to unrecognized tax benefits: 2015 2014 2013 Balance at beginning of year $ 1,944 $ 2,212 $ 5,482 Adjustments related to prior year tax positions 1,318 (915 ) (200 ) Increases related to current year tax positions 1,236 647 648 Decreases due to settlements — — (1,227 ) Decreases related to prior year tax positions — — (2,491 ) Balance at end of year $ 4,498 $ 1,944 $ 2,212 We continue to believe that our tax positions meet the more-likely-than-not standard required under the recognition phase of the authoritative guidance. However, we consider the amounts and probabilities of the outcomes that can be realized upon ultimate settlement with the tax authorities and determined unrecognized tax benefits primarily related to credits should be established as noted in the summary rollforward above. Approximately $0.7 million , $0.7 million , and $0.3 million of the total unrecognized tax benefits as of December 31, 2015, 2014, and 2013, respectively, would reduce our annual effective tax rate if recognized. Additional amounts in the summary rollforward could impact our effective tax rate if we did not maintain a full valuation allowance on our net deferred tax assets. We do not expect our unrecognized tax benefits to change significantly over the next 12 months . With a few exceptions, we are no longer subject to U.S. federal, state and local income tax examinations for years before 2009. Our policy is to recognize interest and/or penalties related to unrecognized tax benefits in income tax expense in the consolidated statements of operations. |
Selected Quarterly Financial Da
Selected Quarterly Financial Data (Unaudited) | 12 Months Ended |
Dec. 31, 2015 | |
Quarterly Financial Information Disclosure [Abstract] | |
Selected Quarterly Financial Data | SELECTED QUARTERLY FINANCIAL DATA (UNAUDITED) Selected quarterly financial data (unaudited) for the year ended December 31, 2015 and 2014 is presented below: Quarter Ended (Unaudited) March 31 June 30 September 30 December 31 2015 Total revenues $ 38,618 $ 44,982 $ 28,627 $ 50,329 Operating loss $ (21,661 ) $ (34 ) $ (16,074 ) $ (2,963 ) Net loss $ (25,562 ) $ (2,346 ) $ (18,724 ) $ (4,153 ) Net loss per share, basic $ (0.39 ) $ (0.04 ) $ (0.28 ) $ (0.07 ) Net loss per share, diluted $ (0.39 ) $ (0.04 ) $ (0.28 ) $ (0.07 ) 2014 Total revenues $ 40,124 $ 46,855 $ 47,990 $ 51,861 Operating loss $ (24,414 ) $ (1,396 ) $ (4,127 ) $ (1,632 ) Net loss $ (27,641 ) $ (3,563 ) $ (11,539 ) $ (2,976 ) Net loss per share, basic $ (0.44 ) $ (0.06 ) $ (0.18 ) $ (0.05 ) Net loss per share, diluted $ (0.44 ) $ (0.06 ) $ (0.18 ) $ (0.05 ) Net loss per basic and diluted shares are computed independently for each of the quarters presented based on basic and diluted shares outstanding per quarter and, therefore, may not sum to the totals for the year. |
Subsequent Event
Subsequent Event | 12 Months Ended |
Dec. 31, 2015 | |
Subsequent Events [Abstract] | |
Subsequent Event | SUBSEQUENT EVENTS Out-License of ZEVALIN, FOLOTYN, BELEODAQ, and MARQIBO in Canada On January 8, 2016, we entered into a strategic partnership with Servier Canada, Inc. for the out-licenses of ZEVALIN, FOLOTYN, BELEODAQ, and MARQIBO. We will receive $6 million in upfront payments, development milestone payments if/when achieved, and a high single-digit royalty on their sales of these products. FDA Approval of EVOMELA On March 10, 2016, the FDA communicated its approval of our NDA for EVOMELA. Upon receipt of FDA approval, we are contractually obligated to make a $6.0 million milestone payment to Ligand Pharmaceuticals Incorporated within 30 days (see Note 10(b) ); accordingly, this payment is due no later than April 9, 2016. |
Schedule II - Valuation and Qua
Schedule II - Valuation and Qualifying Accounts | 12 Months Ended |
Dec. 31, 2015 | |
Valuation and Qualifying Accounts [Abstract] | |
Schedule II - Valuation and Qualifying Accounts | SCHEDULE II – VALUATION AND QUALIFYING ACCOUNTS Years Ended December 31, 2015 , 2014 , and 2013 Additions Description Balance at Additions Charged Deductions (1) Balance at (in thousands) December 31, 2015 Allowance for doubtful accounts $ 120 $ — $ — $ — $ 120 December 31, 2014 Allowance for doubtful accounts $ 206 $ (85 ) $ — $ (1 ) $ 120 December 31, 2013 Allowance for doubtful accounts $ 228 $ 11 $ — $ (33 ) $ 206 (1) Deductions represent the actual write-off of accounts receivable balances. |
Description of Business, Basi29
Description of Business, Basis of Presentation, and Operating Segment (Policies) | 12 Months Ended |
Dec. 31, 2015 | |
Accounting Policies [Abstract] | |
Description of Business | Description of Business Spectrum Pharmaceuticals, Inc. (“Spectrum”, the “Company”, “we”, “our”, or “us”) is a biotechnology company, with a primary strategy comprised of acquiring, developing, and commercializing a broad and diverse pipeline of late-stage clinical and commercial products. In addition to an in-house clinical development organization with regulatory and data management capabilities, we have established a commercial infrastructure for our marketed products. Currently, we have six approved oncology/hematology products that target different types of non-Hodgkin's lymphoma ("NHL"), advanced metastatic colorectal cancer, acute lymphoblastic leukemia ("ALL"), and multiple myeloma ("MM"). We also have two drugs in late stage development: • SPI-2012, is being developed for chemotherapy-induced neutropenia in patients with breast cancer. • EOQUIN® (previously referred to as APAZIQUONE for intravesical instillation), is being developed for immediate intravesical instillation post-transurethral resection of bladder tumors in patients with non-muscle invasive bladder cancer. |
Basis of Presentation | Basis of Presentation Principles of Consolidation The accompanying Consolidated Financial Statements in this Annual Report on Form 10-K have been prepared in accordance with generally accepted accounting principles in the United States of America (“GAAP”) and with the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”). These financial statements include the financial position, results of operations, and cash flows of Spectrum and its subsidiaries, all of which are wholly-owned (except for SPC, as discussed below). All inter-company accounts and transactions among these legal entities have been eliminated in consolidation. Variable Interest Entity We own fifty -percent of Spectrum Pharma Canada (“SPC”), a legal entity organized in Quebec, Canada in January 2008. Certain of our drug clinical studies are conducted through this “variable interest entity” (as defined under applicable GAAP) and we fund all of SPC’s operating costs. Since we carry the full risks and rewards of SPC, we meet the applicable GAAP criteria as being its “primary beneficiary.” Accordingly, SPC’s balance sheets and statements of operations are included in our Consolidated Financial Statements as if it were a wholly-owned subsidiary for all periods presented. |
Operating Segment | Operating Segment We operate in one reportable operating segment that is focused exclusively on developing and commercializing oncology and hematology drug products. For the years ended December 31, 2015 , 2014 , and 2013 , all of our revenue and related expenses were solely attributable to these activities. Substantially all of our assets (excluding our cash held in certain foreign bank accounts and our ZEVALIN distribution rights for the Ex-U.S. territory) are held in the U.S |
Revenue Recognition | Revenue Recognition (a) Product Sales : We sell our products to wholesalers/distributors (i.e., our customers), except for our U.S. sales of ZEVALIN in which case the end-user (i.e., clinic or hospital) is our customer. Our wholesalers distributors in turn sell our products directly to clinics, hospitals, and private oncology-based practices. Revenue from product sales is recognized when title and risk of loss have transferred to our customer, and the following additional criteria are met: (1) appropriate evidence of a binding arrangement exists with our customer; (2) price is substantially fixed and determinable; (3) collection from our customer is reasonably assured; (4) our customer’s obligation to pay us is not contingent on resale of the product; (5) we do not have significant continued performance obligations to our customer; and (6) we have a reasonable basis to estimate returns. Our gross revenue is reduced by our gross-to-net (“GTN”) estimates each period, resulting in our reported “product sales, net” in the accompanying Consolidated Statements of Operations. We defer revenue recognition in full if these estimates are not reasonably determinable at the time of sale. These estimates are based upon information received from external sources (such as written and oral information obtained from our customers with respect to their period-end inventory levels and their sales to end-users during the period), in combination with management’s informed judgments. Due to the inherent uncertainty of estimates, the actual amount we incur may be materially different than our GTN estimates, and require prospective revenue adjustments in periods after the initial sale was recorded. Our GTN estimates are comprised of the following categories: Product Returns Allowances : Our FUSILEV, MARQIBO, and BELEODAQ customers are permitted to return purchased products beginning at its expiration date and within six months thereafter. Returned product is generally not resold. Returns for expiry of ZEVALIN and FOLOTYN are not contractually, or customarily, allowed. We estimate expected returns based on historical return rates. Government Chargebacks : Our products are subject to pricing limits under certain federal government programs (e.g., Medicare and 340B Drug Pricing Program). Qualifying entities (i.e., end-users) purchase products from our customers at their qualifying discounted price. The chargeback amount we incur represents the difference between our contractual sales price to our customer, and the end-user’s applicable discounted purchase price under the government program. There may be significant lag time between our reported net product sales and our receipt of the corresponding government chargeback claims from our customers. Prompt Pay Discounts : Discounts for prompt payment are estimated at the time of sale, based on our eligible customers’ prompt payment history and the contractual discount percentage. Commercial Rebates : Commercial rebates are based on (i) our estimates of end-user purchases through a group purchasing organization ("GPO"), (ii) the corresponding contractual rebate percentage tier we expect each GPO to achieve, and (iii) our estimates of the impact of any prospective rebate program changes made by us. Medicaid Rebates : Our products are subject to state government-managed Medicaid programs, whereby rebates are issued to participating state governments. These rebates arise when a patient treated with our product is covered under Medicaid, resulting in a discounted price for our product under the applicable Medicaid program. Our Medicaid rebate accrual calculations require us to project the magnitude of our sales, by state, that will be subject to these rebates. There is a significant time lag in us receiving rebate notices from each state (generally several months or longer after our sale is recognized). Our estimates are based on our historical claim levels by state, as supplemented by management’s judgment. Distribution, Data, and GPO Administrative Fees : Distribution, data, and GPO administrative fees are paid to authorized wholesalers/distributors of our products (except for U.S. sales of ZEVALIN) for various commercial services, including: contract administration, inventory management, delivery of end-user sales data, and product returns processing. These fees are based on a contractually-determined percentage of our applicable sales. (b) License Fees : We recognize revenue for our licensing of intellectual property to third-parties (out-licenses), based on the contractual terms of each agreement and our application of pertinent GAAP. This revenue may be associated with upfront license fees, milestone payments from our licensees’ sales or regulatory achievements, and royalties from our licensees’ sales in applicable territories. (c) Service Revenue : We receive fees from third-parties under certain arrangements for our research and development activities, sales and marketing activities, clinical trial management, and supply chain services. Payment may be triggered by the successful completion of a phase of development, results from a clinical trial, regulatory approval events, or completion of product or service delivery in our capacity as an agent or principal in such arrangement. We recognize revenue when the corresponding milestone is achieved, or the revenue is otherwise earned and due to us through our on-going activities. (d) New Revenue Recognition Standard : On April 1, 2015, the FASB voted for a one-year deferral of the effective date of the new revenue recognition standard, ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606) (“ASU 2014-09”). ASU 2014-09 is now effective for us beginning January 1, 2018, requiring revenue recognition in a manner that reasonably reflects the delivery of our goods or services to customers in return for expected consideration. To achieve this core principle, the guidance provides the following steps: (1) identify the contract(s) with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when (or as) the entity satisfies a performance obligation. We intend to apply the cumulative effect transition method of ASU 2014-09, and we continue to evaluate the impact of this new standard to our current revenue recognition models for product sales , license fees , and service revenue , as described above. |
Cash and Equivalents | Cash and Cash Equivalents Cash and cash equivalents consist of bank deposits and highly liquid investments with maturities of three months or less from the purchase date. |
Marketable Securities | Marketable Securities Our marketable securities consist of our holdings in mutual funds and bank certificates of deposit. Since we classify these securities as “available-for-sale” under applicable GAAP, any unrealized gains or losses from their change in value is reflected in “unrealized (loss) gain on securities” on the accompanying Consolidated Statements of Comprehensive Loss. Realized gains and losses on available-for-sale securities are included in “other (expense) income, net” on the accompanying Consolidated Statements of Operations. |
Accounts Receivable | Accounts Receivable Our accounts receivables are derived from our product sales, license fees, and service revenue, and do not bear interest. The allowance for doubtful accounts is management’s best estimate of the amount of probable credit losses in existing accounts receivable. Account balances are charged off against the allowance after appropriate collection efforts are exhausted. |
Inventories | Inventories We value inventory at the lower of (i) the actual cost of its purchase or manufacture, or (ii) its current market value. Inventory cost is determined on the first-in, first-out method (FIFO). We regularly review our inventory quantities in process of manufacture and on hand. When appropriate, we record a provision for obsolete and excess inventory to derive its new cost basis, which takes into account our sales forecast by product and corresponding expiry dates. Direct and indirect manufacturing costs related to the production of inventory prior to U.S. Food and Drug Administration ("FDA") approval are expensed through “research and development,” rather than being capitalized to inventory cost. |
Property and Equipment | Property and Equipment Our property and equipment is stated at historical cost, and is depreciated on a straight-line basis over an estimated useful life that corresponds with its designated asset category. We evaluate the recoverability of “long-lived assets” (which includes property and equipment) whenever events or changes in circumstances in our business indicate that the asset’s carrying amount may not be recoverable through on-going operations. |
Goodwill and Intangible Assets | Goodwill and Intangible Assets Our goodwill represents the excess of our business acquisition cost over the estimated fair value of the net assets acquired in the corresponding transaction. Goodwill has an indefinite accounting life and is therefore not amortized. Instead, goodwill is evaluated for impairment on an annual basis (as of each October 1st), unless we identify impairment indicators that would require earlier testing. We evaluate the recoverability of indefinite-lived intangible assets at least annually, or whenever events or changes in our business indicate that an intangible asset’s (whether indefinite or definite-lived) carrying amount may not be recoverable. Such circumstances could include, but are not limited to the following: (a) a significant decrease in the market value of an asset; (b) a significant adverse change in the extent or manner in which an asset is used; or (c) an accumulation of costs significantly in excess of the amount originally expected for the acquisition of an asset. Intangible assets with finite useful lives are amortized over their estimated useful lives on a straight-line basis. We review these assets for potential impairment if/when facts or circumstances suggest that the carrying value of these assets may not be recoverable. |
Stock-Based Compensation | Stock-Based Compensation Stock-based compensation expense for equity awards granted to our employees and members of our board of directors is recognized on a straight-line basis over each award's vesting period. Recognized compensation expense is net of an estimated forfeiture rate, representing the percentage of awards that are expected to be forfeited (by termination of employment or service) prior to vesting. We use the Black-Scholes option pricing model to determine the fair value of stock options (as of the date of grant) which carry service conditions for vesting. We use the Monte Carlo valuation model to value equity awards (as of the date of grant) which carry combined market conditions and service conditions for vesting. The calculation of the fair value of stock options and the recognition of stock-based compensation expense requires uncertain assumptions, including (a) the pre-vesting forfeiture rate of the award, (b) the expected term of the stock option, (c) the stock price volatility over the term of the stock option, and (d) the risk-free interest rate over the term of the stock option. We estimate forfeiture rates based on our employees’ overall forfeiture history, which we believe will be representative of future results. We estimate the expected term of stock options granted based on our employees’ historical exercise patterns, which we believe will be representative of their future behavior. We estimate the volatility of our common stock on the date of grant based on historical volatility of our common stock for a look-back period that corresponds with the expected term. We estimate the risk-free interest rate based upon the U.S. Treasury yields in effect at award grant, for a period equaling the stock options’ expected term. |
Foreign Currency Translation | Foreign Currency Translation We translate the assets and liabilities of our foreign subsidiaries that are stated in their functional currencies (i.e., local operating currencies), to U.S. dollars at the rates of exchange in effect at the reported balance sheet date. Revenues and expenses are translated using the monthly average exchange rates during the reported period. Unrealized gains and losses from the translation of our subsidiaries’ financial statements (that are initially denominated in the corresponding functional currency) are included as a separate component of “accumulated other comprehensive loss” in the Consolidated Balance Sheets. We record foreign currency transactions, when initially denominated in a currency other than the respective functional currency of our subsidiary, at the prevailing exchange rate on the date of the transaction. Resulting unrealized foreign exchange gains and losses from transactions with third parties are included in “accumulated other comprehensive loss” in the Consolidated Balance Sheets. Beginning April 1, 2015, all unrealized foreign exchange gains and losses associated with our intercompany loans were included in "accumulated other comprehensive loss" in the Consolidated Balance Sheets, as these loans with our foreign subsidiaries are no longer expected to be settled in the "foreseeable future." For the period January 1, 2015 through March 31, 2015, unrealized foreign exchange gains and losses associated with our intercompany loans were included in "accumulated other comprehensive loss" in the Consolidated Balance Sheets and in "other expense (income), net" in the Consolidated Statements of Operations. In periods prior to January 1, 2015, all unrealized foreign exchange gains and losses associated with intercompany loans were included in “other expense (income), net” in the Consolidated Statements of Operations. |
Basic and Diluted Net (Loss) Income per Share | Basic and Diluted Net (Loss) Income per Share We calculate basic and diluted net (loss) income per share using the weighted average number of common shares outstanding during the periods presented. In periods of a net loss, basic and diluted loss per share are the same. For the diluted earnings per share calculation, we adjust the weighted average number of common shares outstanding to include only dilutive stock options, warrants, and other common stock equivalents outstanding during the period. |
Income Taxes | Income Taxes Deferred tax assets and liabilities are recorded based on the estimated future tax effects of temporary differences between the tax basis of assets and liabilities and amounts reported in the financial statements, as well as operating losses and tax credit carry forwards using enacted tax rates and laws that are expected to be in effect when the differences are expected to reverse. Realization of deferred tax assets is dependent upon future earnings, the timing and amount of which are uncertain. We have recorded a valuation allowance to reduce our net deferred tax assets, because we believe that, based upon a weighting of positive and negative factors, it is more likely than not that these deferred tax assets will not be realized. If/when we were to determine that our deferred tax assets are realizable, an adjustment to the corresponding valuation allowance would increase our net income in the period that such determination was made. In the event that we are assessed interest and/or penalties from taxing authorities that have not been previously accrued, such amounts would be included in “Provision for income taxes” within the Consolidated Statements of Operations in the period the notice was received. |
Research and Development Costs | Research and Development Costs Research and development costs are expensed as incurred, or as certain milestone payments become due, generally triggered by contractual clinical or regulatory events. |
Fair Value Measurements | Fair Value Measurements We determine measurement-date fair value based on the proceeds that would be received through the sale of the asset, or that we would pay to settle or transfer the liability, in an orderly transaction between market participants. We utilize valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible. Fair value measurements are based on a three-tier hierarchy that prioritizes the inputs used to measure fair value. These tiers include the following: Level 1: Quoted prices (unadjusted) in active markets for identical assets or liabilities that are publicly accessible at the measurement date. Level 2: Observable prices that are based on inputs not quoted on active markets, but that are corroborated by market data. These inputs may include quoted prices for similar assets or liabilities or quoted market prices in markets that are not active to the general public. Level 3: Unobservable inputs are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs. |
Balance Sheet Account Detail (T
Balance Sheet Account Detail (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Summary of Cash and Cash Equivalents and Marketable Securities | The following is a summary of our presented “cash and cash equivalents” and “marketable securities”: Cost Gross Gross Estimated Cash and Marketable Securities Current Long December 31, 2015 Bank deposits $ 59,625 $ — $ — $ 59,625 $ 59,625 $ — $ — Money market funds 80,116 — — 80,116 80,116 — — Bank certificate of deposits 245 — — 245 — 245 — Total cash and equivalents and marketable securities $ 139,986 $ — $ — $ 139,986 $ 139,741 $ 245 $ — December 31, 2014 Bank deposits $ 62,997 $ — $ — $ 62,997 $ 62,997 $ — $ — Money market funds 66,945 — — 66,945 66,945 — — Bank certificate of deposits 244 — — 244 — 244 — Mutual funds 3,062 — — 3,062 — 3,062 — Total cash and equivalents and marketable securities $ 133,248 $ — $ — $ 133,248 $ 129,942 $ 3,306 $ — |
Schedule of Property and Equipment Net of Accumulated Depreciation | “Property and equipment, net of accumulated depreciation” consist of the following: December 31, 2015 2014 Computers hardware and software $ 3,785 $ 3,616 Laboratory equipment 608 643 Office furniture 355 344 Leasehold improvements 2,872 2,847 Property and equipment, at cost 7,620 7,450 (Less): Accumulated depreciation (6,702 ) (6,045 ) Property and equipment, net of accumulated depreciation $ 918 $ 1,405 |
Components of Inventories | “Inventories” consist of the following: December 31, 2015 2014 Raw materials $ 1,606 $ 1,507 Work in process* 4,228 3,979 Finished goods 1,498 3,714 (Less:) Non-current portion of inventories included within "other assets" ** $ (3,156 ) $ — Inventories $ 4,176 $ 9,200 *Our work-in-process inventory at December 31, 2015 includes $0.8 million of packaged but unlabeled ZEVALIN vials with expiry in December 2017 (with possible extensions thereafter). In addition to the amounts presented at December 31, 2015, we received $3.4 million of ZEVALIN antibody materials in January 2016 for its future manufacture (representing strategic long-term supply). We expect to sell our existing and committed ZEVALIN inventory over the next few years. However, if our production strategy changes in our transition to a new contract manufacturer, it could result in a charge in that period to “cost of product sales (excludes amortization of intangible assets)” within the Consolidated Statements of Operations. ** The non-current portion of inventories included within "other assets" at December 31, 2015 of $3.2 million , represents inventories we don't expect to sell within the next twelve months based on current estimates. |
Summary of Customers Representing 10% or More of Accounts Receivables | A summary of our customers that represent 10% or more of our accounts receivables as of December 31, 2015 and 2014 are as follows: Year Ended December 31, 2015 2014 McKesson Corporation and its affiliates $ 20,281 66.7 % $ 22,534 31.9 % Cardinal Health, Inc. and its affiliates 7,241 23.8 % 8,432 11.9 % Oncology Supply, a division of ASD Specialty Healthcare, Inc., and its affiliates (excluding ICS) * — % 36,154 51.1 % All other customers 2,862 9.4 % 3,638 5.1 % Total Accounts Receivables, net $ 30,384 100.0 % $ 70,758 100.0 % * Less than 10% |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure | “Prepaid expenses and other assets” consist of the following: December 31, 2015 2014 Prepaid operating expenses $ 3,507 $ 3,112 2018 Convertible Notes issuance costs (current portion) 699 662 Prepaid expenses and other assets $ 4,206 $ 3,774 |
Schedule of Other Receivables | “Other receivables” consist of the following: December 31, 2015 2014 Income tax receivable $ 1,301 $ 1,387 Insurance receivable 7,100 — Mundipharma promissory note 2,215 — Research and development expenses - reimbursements due 1,699 4,102 Other miscellaneous receivables 257 — Other receivables $ 12,572 $ 5,489 |
Components of Intangible Assets Net of Accumulated Amortization | December 31, 2014 Historical Cost Accumulated Amortization Foreign Currency Translation Impairment Net Amount MARQIBO IPR&D (NHL indications) $ 17,600 $ — $ — $ — $ 17,600 EVOMELA IPR&D 7,700 — — — 7,700 BELEODAQ distribution rights 25,000 (937 ) — — 24,063 MARQIBO distribution rights 26,900 (4,225 ) — — 22,675 FOLOTYN distribution rights 118,400 (20,030 ) — — 98,370 ZEVALIN distribution rights – U.S. 41,900 (27,134 ) — — 14,766 ZEVALIN distribution rights – Ex-U.S. 23,490 (7,402 ) (2,162 ) — 13,926 FUSILEV distribution rights 16,778 (6,270 ) — — 10,508 FOLOTYN out-license 27,900 (6,385 ) — (1,023 ) 20,492 Total intangible assets $ 305,668 $ (72,383 ) $ (2,162 ) $ (1,023 ) $ 230,100 “Intangible assets, net of accumulated amortization” consist of the following: December 31, 2015 Historical Accumulated Foreign Impairment Net Amount Full Remaining MARQIBO IPR&D (NHL indication) $ 17,600 $ — $ — $ — $ 17,600 n/a n/a EVOMELA IPR&D 7,700 — — — 7,700 n/a n/a BELEODAQ distribution rights 25,000 (2,812 ) — — 22,188 160 142 MARQIBO distribution rights 26,900 (8,544 ) — — 18,356 81 51 FOLOTYN distribution rights 118,400 (29,474 ) — — 88,926 152 113 ZEVALIN distribution rights – U.S. 41,900 (30,608 ) — — 11,292 123 39 ZEVALIN distribution rights – Ex-U.S. 23,490 (12,632 ) *** (4,353 ) — 6,505 96 51 FUSILEV distribution rights* 16,778 (9,618 ) — (7,160 ) — 56 0 FOLOTYN out-license** 27,900 (9,109 ) — (1,023 ) 17,768 110 79 Total intangible assets $ 305,668 $ (102,797 ) $ (4,353 ) $ (8,183 ) $ 190,335 * On February 20, 2015, the U.S. District Court for the District of Nevada found the patent covering FUSILEV to be invalid, which was upheld on appeal. On April 24, 2015, Sandoz began to commercialize a generic version of FUSILEV. This represented a “triggering event” under applicable GAAP in evaluating the value of our FUSILEV distribution rights as of March 31, 2015, resulting in a $7.2 million impairment charge (non-cash) in the first quarter of 2015. We accelerated amortization expense recognition for the remaining net book value of FUSILEV distribution rights. ** On May 29, 2013, we amended our FOLOTYN collaboration agreement with Mundipharma. As a result of the amendment, Europe and Turkey were excluded from Mundipharma’s commercialization territory, and their royalty rates and milestone payments to us were modified. This constituted a change under which we originally valued the FOLOTYN out-license as part of business combination accounting, resulting in an impairment charge (non-cash) of $1.0 million resulted from this amendment. *** This value is inclusive of $3.7 million of accelerated amortization expense, recorded in the fourth quarter of 2015, which specifically relates to our allocation of the historical cost of certain ZEVALIN ex-U.S. rights out-licensed to Mundipharma (see Note 12 ) at that time. |
Estimated Intangible Asset Amortization Expense | Estimated intangible asset amortization expense (excluding incremental amortization from the reclassification of IPR&D to developed technology) for the five succeeding years and thereafter is as follows: Years Ending December 31 2016 $ 23,360 2017 23,368 2018 23,368 2019 20,762 2020 15,505 2021 and thereafter 58,672 $ 165,035 |
Schedule of Goodwill | “Goodwill” is comprised of the following: December 31, 2015 2014 Acquisition of Talon $ 10,526 $ 10,526 Acquisition of ZEVALIN Ex-U.S. distribution rights 2,525 2,525 Acquisition of Allos 5,346 5,346 Foreign currency exchange translation effects (437 ) (202 ) Goodwill $ 17,960 $ 18,195 |
Summary of Other Assets | “Other assets” are comprised of the following: December 31, 2015 2014 Equity securities and secured promissory note (see Note 11 )* $ 6,689 $ 8,501 Supplies and deposits 185 234 2018 Convertible Notes issuance costs (excluding current portion)** 1,472 2,171 Executive officer life insurance – cash surrender value 9,181 6,958 Inventories - non-current portion $ 3,156 $ — Other assets $ 20,683 $ 17,864 * These equity securities were excluded from “marketable securities” (see Note 3(a) ) due to our intent to hold these securities for at least one year beyond December 31, 2015 , as discussed in Note 11 . Unrealized losses from these equity securities were recognized through “unrealized (loss) gain on available-for-sale securities" within the Consolidated Statements of Comprehensive Loss, and were $1.4 million for the year ended December 31, 2015 . ** In April 2015, the FASB issued Accounting Standards Update 2015-03, Simplifying the Presentation of Debt Issuance Costs (“ASU 2015-03”). ASU 2015-03 requires that debt issuance costs related to a recognized debt liability be presented in the balance sheet as a direct deduction from the carrying amount of that debt liability. However, ASU 2015-03 does not impact the recognition and measurement guidance for debt issuance costs. ASU 2015-03 is effective for our annual and interim reporting periods beginning January 1, 2016. Accordingly, we will record a reclassification of our 2018 Convertible Notes issuance costs, from “other assets” to “convertible senior notes” within our Consolidated Balance Sheets, beginning January 1, 2016. |
Schedule of Accounts Payable and Other Accrued Obligations | Accounts payable and other accrued obligations are comprised of the following: December 31, 2015 2014 Trade accounts payable and other accrueds $ 26,684 $ 24,571 Accrued rebates 18,166 41,782 Accrued product royalty 4,908 5,182 Allowance for returns 1,394 1,135 Accrued data and distribution fees 1,830 3,952 Accrued GPO administrative fees 1,058 3,222 Inventory management fee 498 1,110 Allowance for chargebacks 2,001 4,040 Accounts payable and other accrueds $ 56,539 $ 84,994 |
Schedule of Amounts Presented in Accounts Payable and Other Accrued Obligations | Amounts presented within “accounts payable and other accrued liabilities” in the accompanying Consolidated Balance Sheets for GTN estimates (see Note 2(i) ) were as follows: Description Rebates and Data and Returns Balance as of December 31, 2013 $ 33,967 $ 5,373 $ 2,900 Add: provisions (recovery) 76,636 21,330 (78 ) (Less): credits or actual allowances (64,781 ) (18,419 ) (1,687 ) Balance as of December 31, 2014 45,822 8,284 1,135 Add: provisions 75,498 15,928 1,486 (Less): credits or actual allowances (101,153 ) (20,826 ) (1,227 ) Balance as of December 31, 2015 $ 20,167 $ 3,386 $ 1,394 |
Deferred Revenue, by Arrangement, Disclosure | Deferred revenue (including current and long-term) is comprised of the following: December 31, 2015 2014 CASI out-license (see Note 11) $ — $ 9,959 FUSILEV deferred revenue* 6,083 — Dr. Reddy's out-license (see Note 17(b)(iii)) 430 — Deferred revenue $ 6,513 $ 9,959 * During the third quarter 2015, we deferred revenue recognition related to certain FUSILEV product shipments that did not meet our revenue recognition criteria (see Note 2(i)(a) ), aggregating $9.9 million . Specifically, this deferral is a result of our inability to estimate future rebate values (with requisite precision) offered to our customers in order to compete with generic products. During the fourth quarter of 2015, we recognized $3.8 million for these third quarter shipments within "Product sales, net." As of December 31, 2015 , $6.1 million of these third quarter 2015 shipments remains deferred. |
Summary of Other Long-Term Liabilities | Other long-term liabilities are comprised of the following: December 31, 2015 2014 Accrued executive deferred compensation $ 6,458 $ 4,694 Deferred rent (non-current portion) 248 364 Business acquisition liability — 300 Other tax liabilities 738 730 Other long-term liabilities $ 7,444 $ 6,088 |
Gross-to-Net Product Sales (Tab
Gross-to-Net Product Sales (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Revenue, Net [Abstract] | |
Reconciliation of Gross to Net Product Sales | The below table presents a GTN product sales reconciliation for the accompanying Consolidated Statement of Operations: 2015 2014 2013 Gross product sales $ 215,136 $ 284,685 $ 224,301 Commercial rebates and government chargebacks (61,283 ) (76,636 ) (63,610 ) Distribution, data, and GPO administrative fees (15,613 ) (21,330 ) (19,067 ) Prompt pay discounts (16 ) (260 ) (183 ) Product returns allowances (1,373 ) 78 2,034 Product sales, net $ 136,851 $ 186,537 $ 143,475 |
Net Product Sales by Geograph32
Net Product Sales by Geographic Region, Product Line, and Gross Product Sales by Significant Customers (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Segment Reporting [Abstract] | |
Schedule of Net Product Sales by Geography | The below table presents our net product sales by geography for the years ended December 31, 2015 , 2014 , and 2013 : Net Product Sales by Geographic Region Year Ended December 31, 2015 2014 2013 United States $ 130,432 95.3 % $ 177,979 95.4 % $ 133,462 93.0 % International: Europe (ZEVALIN and FOLOTYN only) 2,234 1.6 % 3,357 1.8 % 3,953 2.8 % Asia Pacific (ZEVALIN only) 4,185 3.1 % 5,201 2.8 % 6,060 4.2 % Total International 6,419 4.7 % 8,558 4.6 % 10,013 7.0 % Net product sales $ 136,851 100 % $ 186,537 100.0 % $ 143,475 100.0 % |
Schedule of Net Product Sales by Product Line | Net Sales by Product The below table presents our net product sales by product for the years ended December 31, 2015 , 2014 , and 2013 : Year Ended December 31, 2015 2014 2013 FUSILEV $ 60,710 44.4 % $ 105,608 56.6 % $ 68,397 47.7 % FOLOTYN 40,606 29.7 % 47,556 25.5 % 44,370 30.9 % ZEVALIN 17,457 12.8 % 22,169 11.9 % 29,393 20.5 % MARQIBO 8,006 5.9 % 6,328 3.4 % 1,315 0.9 % BELEODAQ 10,072 7.4 % 4,876 2.6 % — — % Net product sales $ 136,851 100.0 % $ 186,537 100.0 % $ 143,475 100.0 % |
Summary of Customers Representing 10% or More of Gross Product Sales | The below table presents the customers that represent 10% or more of our gross product sales in 2015 , 2014 , and 2013 : Year Ended December 31, 2015 2014 2013 Oncology Supply, a division of ASD Specialty Healthcare, Inc., and its affiliates (excluding ICS) $ 78,989 36.7 % $ 115,079 40.4 % $ 79,497 35.4 % McKesson Corporation and its affiliates 73,577 34.2 % 93,656 32.9 % 44,350 19.8 % Integrated Commercialization Solutions, Inc. (“ICS”) * — % * — % 35,548 15.8 % Cardinal Health, Inc. and its affiliates 37,414 17.4 % * — % * — % All Other Customers 25,156 11.7 % 75,950 26.7 % 64,906 29.0 % Gross product sales $ 215,136 100.0 % $ 284,685 100.0 % $ 224,301 100.0 % * Less than |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Summary of Stock-Based Compensation Expense | Stock-based compensation expense included within “Total operating costs and expenses” for years ended December 31, 2015 , 2014 and 2013 was as follows: Year Ended December 31, 2015 2014 2013 Cost of product sales $ 62 $ — $ — Selling, general and administrative 10,049 10,053 10,762 Research and development 1,973 1,756 2,017 Total $ 12,084 $ 11,809 $ 12,779 |
Fair Value of Stock Options Granted Using Black-Scholes Option Pricing Model | The fair value of stock options granted was estimated at the date of grant using the Black-Scholes option-pricing model. The following assumptions were used to determine fair value for the stock awards granted in the applicable year: Year Ended December 31, 2015 2014 2013 Expected option life (in years) (a) 5.43 4.95 4.95 Risk-free interest rate (b) 1.25% - 1.68% 0.58% - 1.52% 0.35% - 0.78% Volatility (c) 48.0% - 50.2% 48.9% - 62.1% 58.3% -71.5% Dividend yield (d) —% —% —% Weighted-average grant-date fair value per stock option $2.85 $3.49 $4.66 (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. |
Summary of Stock Option Activity | Stock option activity during the years ended December 31, 2015 , 2014 and 2013 is as follows: Number of Weighted- Weighted- Aggregate Outstanding — December 31, 2012 10,399,265 $ 6.57 Granted 2,041,300 8.92 Exercised (825,884 ) 4.40 $ 3,435 (1 ) Forfeited (202,882 ) 8.22 Expired (82,581 ) 8.91 Outstanding — December 31, 2013 11,329,218 7.10 Granted 2,576,292 7.60 Exercised (485,260 ) 4.77 $ 1,629 (1 ) Forfeited (557,109 ) 9.65 Expired (214,039 ) 10.70 Outstanding — December 31, 2014 12,649,102 7.12 Granted 2,219,587 6.04 Exercised (456,082 ) 4.45 $ 977 (1 ) Forfeited (296,162 ) 8.06 Expired (279,594 ) 9.05 Outstanding — December 31, 2015 13,836,851 $ 6.97 6.34 $ 7,516 (2 ) Vested (exercisable) — December 31, 2015 10,235,721 $ 6.94 5.40 $ 7,159 (2 ) Unvested (unexercisable) — December 31, 2015 3,601,130 $ 7.06 9.00 $ 357 (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 2015 and the stock option exercise price, multiplied by the number of in-the-money options as of December 31, 2015 . The amount of intrinsic value will change based on the fair market value of our stock. |
Summary of Stock Option Grants | The following table summarizes information with respect to stock option grants as of December 31, 2015 : Outstanding Exercisable Exercise Price Granted Stock Weighted- Weighted- Granted Weighted- $0.92 - 3.15 1,090,385 2.49 $ 2.18 1,090,385 $ 2.18 $3.16 - 4.95 1,378,444 4.29 4.24 1,378,444 4.24 $4.96 - 6.9 4,394,294 6.14 6.08 2,999,511 6.22 $6.91 - 8.99 4,500,895 7.61 7.78 2,595,943 7.95 $9.00 - 16.32 2,472,833 7.21 10.71 2,171,438 10.83 13,836,851 6.34 $ 6.97 10,235,721 $ 6.94 |
Summary of Restricted Stock Award Activity | A summary of restricted stock award activity is as follows: Number of Weighted Average Unvested — December 31, 2012 1,034,604 $ 11.00 Granted 523,800 8.74 Vested (501,660 ) 9.72 Forfeited (49,625 ) 10.60 Unvested — December 31, 2013 1,007,119 10.09 Granted 581,194 7.52 Vested (578,985 ) 10.24 Forfeited (185,111 ) 9.88 Unvested — December 31, 2014 824,217 8.22 Granted 1,948,585 6.32 Vested (364,507 ) 8.47 Forfeited (234,313 ) 7.32 Unvested — December 31, 2015 2,173,982 $ 6.58 |
Fair Value of Restricted Stock Awards | 2015 2014 2013 Restricted stock expense $ 4,006 $ 3,830 $ 4,202 |
Issued Shares of Common Stock | We issued shares of common stock to our employees in connection with our 401(k) program, partially matching our employees’ annual 401(k) contributions, as summarized below: 2015 2014 2013 Shares of common stock issued 179,865 133,734 99,359 Match contribution value* $ 1,124 $ 1,028 $ 860 * Represents our stock price on the date of the common stock issuance multiplied by the number of shares of common stock issued. |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Equity [Abstract] | |
Shares of Common Stock Issuable on Conversion or Exercise of Rights Granted | As of December 31, 2015 , 26 million shares of our common stock were issuable upon conversion, or exercise of rights granted (regardless of whether in or out-of-the-money), as summarized below: Conversion of Series E Preferred Stock 40,000 2018 Convertible Notes 11,401,284 Exercise of issued employee stock options 13,836,851 Exercise of issued warrants 445,000 Management incentive plan restricted stock units 260,000 Total common shares 25,983,135 |
Summary of Warrant Activity | A summary of warrant activity is as follows: Number of Weighted Outstanding — December 31, 2012 395,000 $ 5.45 Granted 50,000 7.51 Outstanding — December 31, 2013 445,000 $ 6.39 Granted — — Outstanding — December 31, 2014 445,000 $ 6.39 Granted — — Outstanding — December 31, 2015 445,000 $ 6.78 Exercisable — December 31, 2015 445,000 $ 6.78 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Earnings Per Share [Abstract] | |
Computation of Net (Loss) Income Per Share | Net loss per share was computed by dividing net loss by the weighted average number of common shares outstanding for the years ended December 31, 2015 , 2014 , and 2013 : Year Ended December 31, 2015 2014 2013 Net loss $ (50,785 ) $ (45,719 ) $ (62,134 ) Weighted average shares—basic 64,882,417 64,708,163 60,729,128 Net loss per share—basic $ (0.78 ) $ (0.71 ) $ (1.02 ) Weighted average shares—diluted 64,882,417 64,708,163 60,729,128 Net loss income per share—diluted $ (0.78 ) $ (0.71 ) $ (1.02 ) |
Schedule of Securities Excluded from Calculation of Net (Loss) per Share | The below outstanding securities were excluded from the above calculation of net loss per share because their impact would have been anti-dilutive due to net loss per share, for the years ended, as summarized below: Year Ended December 31, 2015 2014 2013 2018 Convertible Notes 11,401,284 11,401,284 343,600 Common stock options 1,441,086 2,173,916 2,934,625 Restricted stock awards 2,173,615 824,217 1,007,119 Common stock warrants 9,357 120,702 160,816 Preferred stock 40,000 40,000 40,000 Total 15,065,342 14,560,119 4,486,160 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Fair Value Disclosures [Abstract] | |
Summary of Asset and Liability Fair Values | The table below summarizes certain asset and liability fair values that are included within our accompanying Consolidated Balance Sheets, and their designations among three fair value measurement categories: December 31, 2015 Level 1 Level 2 Level 3 Total Assets: Bank certificates of deposits $ — $ 245 $ — $ 245 Money market currency funds — 80,116 — 80,116 Equity securities 5,189 — — 5,189 Mutual funds — — — — Deferred compensation investments, including life insurance cash surrender value — 9,181 — 9,181 $ 5,189 $ 89,542 $ — $ 94,731 Liabilities: Deferred executive compensation liability — 6,458 — 6,458 Deferred drug development liability — — 14,686 14,686 Ligand Contingent Consideration — — 5,227 5,227 Talon CVR — — 1,377 1,377 Corixa Liability — — 62 62 $ — $ 6,458 $ 21,352 $ 27,810 December 31, 2014 Level 1 Level 2 Level 3 Total Assets: Bank certificates of deposits $ — $ 244 $ — $ 244 Money market currency funds — 66,945 — 66,945 Equity securities 7,191 — — 7,191 Mutual funds — 3,062 — 3,062 Deferred compensation investments, including life insurance cash surrender value — 6,958 — 6,958 $ 7,191 $ 77,209 $ — $ 84,400 Liabilities: Deferred executive compensation liability — 4,694 — 4,694 Deferred development liability — — 15,785 15,785 Ligand Contingent Consideration — — 4,901 4,901 Talon CVR — — 2,379 2,379 Corixa Liability — — 62 62 $ — $ 4,694 $ 23,127 $ 27,821 |
Activity of Level 3 Inputs Measured on Recurring Basis | The following presents a roll forward of our liabilities for which we utilize Level 3 inputs in determining period-end value. These liabilities are included on our Consolidated Balance Sheets within “acquisition related contingent obligations” and “drug development liability”. The basis of the various Level 3 valuation inputs are discussed in the Notes to these accompanying Consolidated Financial Statements. Our carrying amounts of financial instruments such as cash equivalents, accounts receivable, prepaid expenses, accounts payable, and accrued liabilities, excluding acquisition related contingent consideration liabilities, approximate their related fair values due to their short-term nature. Fair Value Measurements of Level 3 ) Balance at December 31, 2013 $ 26,071 Deferred development costs (see Note 16) (1,957 ) Ligand Contingent Consideration (see Note 10(b)) 901 Talon CVR (see Note 10(a)) (1,950 ) Corixa Liability (see Note 17(b)(i)) 62 Balance at December 31, 2014 $ 23,127 Deferred development costs (see Note 16) (1,099 ) Ligand Contingent Consideration (see Note 10(b)) 326 Talon CVR (see Note 10(a)) (1,002 ) Corixa Liability (see Note 17(b)(i)) — Balance at December 31, 2015 $ 21,352 |
Business Combinations and Con37
Business Combinations and Contingent Consideration (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Talon Therapeutics, Inc. [Member] | |
Change in Fair Value of Contingent Consideration Related to Acquisition | Adjustments to CVR fair value are recognized within “change in fair value of contingent consideration related to acquisitions” in the accompanying Consolidated Statements of Operations. Fair Value December 31, 2014 $ 2,379 Fair value adjustment for the year ended December 31, 2015 (1,002 ) December 31, 2015 $ 1,377 |
Acquisition-Date Fair Value of Consideration Transferred | The acquisition-date fair value of the consideration transferred consisted of the following: Cash consideration $ 3,000 Ligand Contingent Consideration 4,700 Total purchase consideration $ 7,700 |
Melphalan license [Member] | |
Change in Fair Value of Contingent Consideration Related to Acquisition | Adjustments to Ligand Contingent Consideration fair value are recognized within “change in fair value of the contingent consideration related to acquisitions” in the accompanying Consolidated Statements of Operations. Fair Value of December 31, 2014 $ 4,901 Fair value adjustment for year ended December 31, 2015 326 December 31, 2015 $ 5,227 |
Summary of Allocation of Total Purchase Price to Net Assets Acquired | The allocation of the total purchase price to the net assets acquired is as follows: IPR&D EVOMELA rights $ 7,700 |
Out-License of Marqibo, Zeval38
Out-License of Marqibo, Zevalin, & Evolmela in China Territory (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Other Commitments [Abstract] | |
Schedule of Proceeds Received and Fair Value on CASI Out-License Execution Date | The proceeds we received, and its fair value on the CASI Out-License execution date, consisted of the following: CASI common stock (5.4 million shares) $ 8,649 (a) CASI secured promissory note due March 17, 2016 (since extended to March 17, 2017), net of fair value discount ($1.5 million face value and 0.5% annual coupon) 1,310 (b) Total consideration received, net of fair value discount $ 9,959 (c) (a) Value determined based on the September 17, 2014 closing price of 5.4 million shares of CASI common stock on the NASDAQ Capital Market of $1.60 per share. Our current intention is to hold these securities on a long-term basis. Accordingly, we have presented its value of $5.2 million as of December 31, 2015 within “other assets” (rather than “marketable securities”) on our accompanying Consolidated Balance Sheets. The change in the value of these securities is reported within “unrealized (loss) gain on available-for-sale securities” on the accompanying Consolidated Statement of Comprehensive Loss. (b) Value estimated using the terms of the $1.5 million promissory note, and the application of a synthetic debt rating based on CASI’s publicly-available financial information, and the prevailing interest yields on similar public debt securities as of September 17, 2014. The face value of the promissory note as of December 31, 2015 is included within "other assets" on the accompanying Consolidated Balance Sheets. (c) Presented within “license fees and service revenue” in the accompanying Consolidated Statement of Operations as of December 31, 2015 . |
Convertible Senior Notes (Table
Convertible Senior Notes (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Debt Disclosure [Abstract] | |
Carrying Value of 2018 Convertible Notes | The carrying value of the 2018 Convertible Notes as of December 31, 2015 is summarized as follows: Principal amount $ 120,000 (Less): Unamortized debt discount (amortized through December 2018) (18,452 ) December 31, 2015 $ 101,548 |
Components of Total Interest Expense, Net Recognized | The following table sets forth the components of interest expense recognized in the accompanying Consolidated Statements of Operations for the 2018 Convertible Notes for the years ended December 31, 2015 and 2014 : Year Ended December 31, 2015 2014 Contractual coupon interest expense $ 3,300 $ 3,300 Amortization of debt issuance costs 662 599 Accretion of debt discount 5,250 4,818 Total $ 9,212 $ 8,717 Effective interest rate 8.66 % 8.66 % |
Mundipharma Agreement (Tables)
Mundipharma Agreement (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Other Liabilities Disclosure [Abstract] | |
Schedule of Drug Development Liability Adjustments | Year Ended December 31, Drug Drug Total Drug Balance at December 31, 2014 $ 1,141 $ 14,644 $ 15,785 Transfer from long term to current in 2015 217 (217 ) — (Less): Expenses incurred in 2015 (1,099 ) — (1,099 ) Balance at December 31, 2015 $ 259 $ 14,427 $ 14,686 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Future Minimum Lease Payments | Our future minimum lease payments are as follows: Year ending December 31, Operating Lease 2016 $ 1,283 2017 1,172 2018 1,209 2019 460 2020 — $ 4,124 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Income Tax Disclosure [Abstract] | |
Components of (Loss) Income before (Provision) Benefit for Income Taxes | The components of loss before provision for income taxes are as follows: For the Years Ended 2015 2014 2013 United States $ (56,554 ) $ (37,327 ) $ (30,437 ) Foreign 6,175 (6,205 ) (6,199 ) Total $ (50,379 ) $ (43,532 ) $ (36,636 ) |
Provision (Benefit) for Income Taxes | The provision for income taxes consist of the following: For the Years Ended 2015 2014 2013 Current: Federal $ 113 $ 1,529 $ (8,357 ) State 5 126 (691 ) Foreign 148 29 — $ 266 $ 1,684 $ (9,048 ) Deferred: Federal 114 495 36,183 State 26 7 (1,637 ) Foreign — — — 140 502 34,546 Total income tax provision $ 406 $ 2,186 $ 25,498 |
Income Tax Provision (Benefit) Differs from Computed Using Federal Statutory Rate Applied to Income before Taxes | The income tax provision differs from that computed using the federal statutory rate applied to income before taxes as follows: 2015 2014 2013 Tax provision computed at the federal statutory rate $ (17,619 ) $ (15,236 ) $ (12,822 ) State tax, net of federal benefit 232 66 (246 ) Research credits (2,974 ) (2,134 ) (2,254 ) FIN 48 uncertain tax positions — — — Change in tax credit carryforwards (4,965 ) — — Transaction costs — (11 ) 880 Officers compensation 1,577 1,895 2,178 Stock based compensation 535 299 501 Permanent items and other (487 ) 21,742 (1,080 ) Domestic manufacturing deduction — (630 ) 767 Tax differential on foreign earnings 1,435 1,570 1,123 Change in tax rate (903 ) (519 ) (283 ) Valuation allowance 23,575 (4,856 ) 36,734 Income tax provision $ 406 $ 2,186 $ 25,498 |
Components of Company's Deferred Tax Assets | Significant components of our deferred tax assets as of December 31, 2015 and 2014 are presented below. A valuation allowance has been recognized to offset the net deferred tax assets as realization of such deferred tax assets no longer meets the “more-likely-than-not” threshold under GAAP. 2015 2014 Deferred tax assets: Net operating loss carry forwards $ 41,251 $ 40,505 Research credits 22,082 9,045 Stock based compensation 4,828 3,703 Deferred revenue 2,280 1,893 Development costs 5,504 5,950 Returns and allowances 1,363 4,161 Other, net 9,887 9,082 Total deferred tax assets before valuation allowance 87,195 74,339 Valuation allowance (71,815 ) (45,983 ) Total deferred tax assets 15,380 28,356 Deferred tax liabilities: Basis difference in debt (713 ) (907 ) Depreciation and amortization differences (21,446 ) (34,088 ) Net deferred tax liability $ (6,779 ) $ (6,639 ) |
Summary of Unrecognized Tax Benefits | The following tabular reconciliation summarizes activity related to unrecognized tax benefits: 2015 2014 2013 Balance at beginning of year $ 1,944 $ 2,212 $ 5,482 Adjustments related to prior year tax positions 1,318 (915 ) (200 ) Increases related to current year tax positions 1,236 647 648 Decreases due to settlements — — (1,227 ) Decreases related to prior year tax positions — — (2,491 ) Balance at end of year $ 4,498 $ 1,944 $ 2,212 |
Selected Quarterly Financial 43
Selected Quarterly Financial Data (Unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Quarterly Financial Information Disclosure [Abstract] | |
Summary of Selected Quarterly Financial Data | Selected quarterly financial data (unaudited) for the year ended December 31, 2015 and 2014 is presented below: Quarter Ended (Unaudited) March 31 June 30 September 30 December 31 2015 Total revenues $ 38,618 $ 44,982 $ 28,627 $ 50,329 Operating loss $ (21,661 ) $ (34 ) $ (16,074 ) $ (2,963 ) Net loss $ (25,562 ) $ (2,346 ) $ (18,724 ) $ (4,153 ) Net loss per share, basic $ (0.39 ) $ (0.04 ) $ (0.28 ) $ (0.07 ) Net loss per share, diluted $ (0.39 ) $ (0.04 ) $ (0.28 ) $ (0.07 ) 2014 Total revenues $ 40,124 $ 46,855 $ 47,990 $ 51,861 Operating loss $ (24,414 ) $ (1,396 ) $ (4,127 ) $ (1,632 ) Net loss $ (27,641 ) $ (3,563 ) $ (11,539 ) $ (2,976 ) Net loss per share, basic $ (0.44 ) $ (0.06 ) $ (0.18 ) $ (0.05 ) Net loss per share, diluted $ (0.44 ) $ (0.06 ) $ (0.18 ) $ (0.05 ) |
Description of Business, Basi44
Description of Business, Basis of Presentation, and Operating Segment - Additional Information (Detail) | 12 Months Ended |
Dec. 31, 2015Segmentproduct | |
Segment Reporting Information [Line Items] | |
Number of products | 6 |
Number of late stage development drugs | 2 |
Number of reportable operating segment | Segment | 1 |
Spectrum Pharma Canada [Member] | |
Segment Reporting Information [Line Items] | |
Ownership interest, percentage | 5000.00% |
Summary of Significant Accoun45
Summary of Significant Accounting Policies and Use of Estimates - Additional Information (Detail) | 12 Months Ended |
Dec. 31, 2015 | |
Accounting Policies [Abstract] | |
Number of months customers are allowed to return products | 6 months |
Cash and equivalents maturities period | 3 months |
Balance Sheet Account Detail -
Balance Sheet Account Detail - Summary of Cash and Cash Equivalents and Marketable Securities (Detail) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Schedule of Investments [Line Items] | ||||
Cash and cash equivalents, Marketable securities, Cost | $ 139,986 | $ 133,248 | ||
Cash and cash equivalents, Marketable securities, Gross Unrealized Gains | 0 | 0 | ||
Cash and cash equivalents, Marketable securities, Gross Unrealized Losses | 0 | 0 | ||
Cash and cash equivalents, Marketable securities, Estimated fair Value | 139,986 | 133,248 | ||
Cash and cash equivalents | 139,741 | 129,942 | $ 156,306 | $ 139,698 |
Marketable Security, Current | 245 | 3,306 | ||
Bank Deposits [Member] | ||||
Schedule of Investments [Line Items] | ||||
Bank deposits, Cost | 59,625 | 62,997 | ||
Bank deposits, Gross Unrealized Gains | 0 | 0 | ||
Bank deposits, Gross Unrealized Losses | 0 | 0 | ||
Bank deposits, Estimated fair Value | 59,625 | 62,997 | ||
Cash and cash equivalents | 59,625 | 62,997 | ||
Money Market Funds [Member] | ||||
Schedule of Investments [Line Items] | ||||
Marketable security, Amortized Cost | 80,116 | 66,945 | ||
Marketable security, Gross Unrealized Gains | 0 | 0 | ||
Marketable security, Gross Unrealized Losses | 0 | 0 | ||
Marketable security, Estimated fair Value | 80,116 | 66,945 | ||
Cash and cash equivalents | 80,116 | 66,945 | ||
Bank CDs [Member] | ||||
Schedule of Investments [Line Items] | ||||
Marketable security, Amortized Cost | 245 | 244 | ||
Marketable security, Gross Unrealized Gains | 0 | 0 | ||
Marketable security, Gross Unrealized Losses | 0 | 0 | ||
Marketable security, Estimated fair Value | 245 | 244 | ||
Marketable Security, Current | $ 245 | 244 | ||
Mutual Funds [Member] | ||||
Schedule of Investments [Line Items] | ||||
Marketable security, Amortized Cost | 3,062 | |||
Marketable security, Gross Unrealized Gains | 0 | |||
Marketable security, Gross Unrealized Losses | 0 | |||
Marketable security, Estimated fair Value | 3,062 | |||
Marketable Security, Current | $ 3,062 |
Balance Sheet Account Detail 47
Balance Sheet Account Detail - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Schedule Of Investments In Marketable Securities [Line Items] | |||
Depreciation expense | $ 700,000 | $ 1,100,000 | $ 1,200,000 |
Intangible assets, impairment | 0 | ||
Intangible assets, net | 190,335,000 | 230,100,000 | |
Intangible asset amortization expense | 38,300,000 | 24,300,000 | $ 21,200,000 |
MARQIBO IPR&D (NHL and further ALL indications) [Member] | |||
Schedule Of Investments In Marketable Securities [Line Items] | |||
Intangible assets, net | 17,600,000 | 17,600,000 | |
C-E MELPHALAN IPR&D [Member] | |||
Schedule Of Investments In Marketable Securities [Line Items] | |||
Intangible assets, net | $ 7,700,000 | $ 7,700,000 |
Balance Sheet Account Detail 48
Balance Sheet Account Detail - Schedule of Property and Equipment Net of Accumulated Depreciation (Detail) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, at cost | $ 7,620 | $ 7,450 |
(Less): Accumulated depreciation | (6,702) | (6,045) |
Property and equipment, net of accumulated depreciation | 918 | 1,405 |
Computers and software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, at cost | 3,785 | 3,616 |
Lab and media equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, at cost | 608 | 643 |
Office furniture and equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, at cost | 355 | 344 |
Leasehold improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, at cost | $ 2,872 | $ 2,847 |
Balance Sheet Account Detail 49
Balance Sheet Account Detail - Components of Inventories (Detail) - USD ($) $ in Thousands | Jan. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 |
Subsequent Event [Line Items] | |||
Raw materials | $ 1,606 | $ 1,507 | |
Work in process | 4,228 | 3,979 | |
Finished goods | 1,498 | 3,714 | |
(Less:) Non-current portion of inventories included within other assets | (3,156) | 0 | |
Inventories | 4,176 | $ 9,200 | |
ZEVALIN [Member] | |||
Subsequent Event [Line Items] | |||
Work in process | $ 800 | ||
ZEVALIN [Member] | Subsequent Event [Member] | |||
Subsequent Event [Line Items] | |||
Work in process | $ 3,400 |
Balance Sheet Account Detail 50
Balance Sheet Account Detail - Summary of Customers Representing 10% or More of Accounts Receivables (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Total Accounts Receivables, net | $ 30,384 | $ 70,758 |
McKesson Corporation and its affiliates [Member] | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Total Accounts Receivables, net | 20,281 | 22,534 |
Cardinal Health, Inc. and its affiliates [Member] | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Total Accounts Receivables, net | 7,241 | 8,432 |
Oncology Supply, a division of ASD Specialty Healthcare, Inc., and its affiliates (excluding ICS) [Member] | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Total Accounts Receivables, net | 36,154 | |
All Other Customers [Member] | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Total Accounts Receivables, net | $ 2,862 | $ 3,638 |
Customer Concentration Risk [Member] | Accounts Receivable [Member] | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Percentage of accounts receivable, net | 100.00% | 100.00% |
Customer Concentration Risk [Member] | Accounts Receivable [Member] | McKesson Corporation and its affiliates [Member] | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Percentage of accounts receivable, net | 66.70% | 31.90% |
Customer Concentration Risk [Member] | Accounts Receivable [Member] | Cardinal Health, Inc. and its affiliates [Member] | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Percentage of accounts receivable, net | 23.80% | 11.90% |
Customer Concentration Risk [Member] | Accounts Receivable [Member] | Cardinal Health, Inc. and its affiliates [Member] | Maximum [Member] | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Percentage of accounts receivable, net | 10.00% | |
Customer Concentration Risk [Member] | Accounts Receivable [Member] | Oncology Supply, a division of ASD Specialty Healthcare, Inc., and its affiliates (excluding ICS) [Member] | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Percentage of accounts receivable, net | 0.00% | 51.10% |
Customer Concentration Risk [Member] | Accounts Receivable [Member] | All Other Customers [Member] | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Percentage of accounts receivable, net | 9.40% | 5.10% |
Balance Sheet Account Detail 51
Balance Sheet Account Detail - Prepaid Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Prepaid operating expenses | $ 3,507 | $ 3,112 |
2018 Convertible Notes issuance costs (current portion) | 699 | 662 |
Prepaid expenses and other assets | $ 4,206 | $ 3,774 |
Balance Sheet Account Detail 52
Balance Sheet Account Detail - Schedule of Other Receivables (Detail) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Income tax receivable | $ 1,301 | $ 1,387 |
Insurance receivable | 7,100 | 0 |
Mundipharma promissory note | 2,215 | 0 |
Research and development expenses - reimbursements due | 1,699 | 4,102 |
Other miscellaneous receivables | 257 | 0 |
Other receivables | $ 12,572 | $ 5,489 |
Balance Sheet Account Detail 53
Balance Sheet Account Detail - Components of Intangible Assets Net of Accumulated Amortization (Detail) - USD ($) $ in Thousands | May. 29, 2013 | Dec. 31, 2015 | Mar. 31, 2015 | Dec. 31, 2015 | Dec. 31, 2014 |
Product Rights [Line Items] | |||||
Historical Cost | $ 305,668 | $ 305,668 | $ 305,668 | ||
Accumulated Amortization | (102,797) | (102,797) | (72,383) | ||
Foreign Currency Translation | (4,353) | (2,162) | |||
Impairment | (8,183) | (1,023) | |||
Net Amount | 190,335 | 190,335 | 230,100 | ||
MARQIBO IPR&D (NHL and further ALL indications) [Member] | |||||
Product Rights [Line Items] | |||||
Historical Cost | 17,600 | 17,600 | 17,600 | ||
Net Amount | 17,600 | 17,600 | 17,600 | ||
EVOMELA IPR&D [Member] | |||||
Product Rights [Line Items] | |||||
Historical Cost | 7,700 | 7,700 | 7,700 | ||
Net Amount | 7,700 | 7,700 | 7,700 | ||
BELEODAQ distribution rights [Member] | |||||
Product Rights [Line Items] | |||||
Historical Cost | 25,000 | 25,000 | 25,000 | ||
Accumulated Amortization | (2,812) | (2,812) | (937) | ||
Net Amount | 22,188 | $ 22,188 | 24,063 | ||
Full Amortization Period (months) | 160 months | ||||
Remaining Amortization Period (months) | 142 months | ||||
MARQIBO distribution rights [Member] | |||||
Product Rights [Line Items] | |||||
Historical Cost | 26,900 | $ 26,900 | 26,900 | ||
Accumulated Amortization | (8,544) | (8,544) | (4,225) | ||
Net Amount | 18,356 | $ 18,356 | 22,675 | ||
Full Amortization Period (months) | 81 months | ||||
Remaining Amortization Period (months) | 51 months | ||||
FOLOTYN distribution rights [Member] | |||||
Product Rights [Line Items] | |||||
Historical Cost | 118,400 | $ 118,400 | 118,400 | ||
Accumulated Amortization | (29,474) | (29,474) | (20,030) | ||
Impairment | $ (1,000) | ||||
Net Amount | 88,926 | $ 88,926 | 98,370 | ||
Full Amortization Period (months) | 152 months | ||||
Remaining Amortization Period (months) | 113 months | ||||
ZEVALIN distribution rights [Member] | United States [Member] | |||||
Product Rights [Line Items] | |||||
Historical Cost | 41,900 | $ 41,900 | 41,900 | ||
Accumulated Amortization | (30,608) | (30,608) | (27,134) | ||
Net Amount | 11,292 | $ 11,292 | 14,766 | ||
Full Amortization Period (months) | 123 months | ||||
Remaining Amortization Period (months) | 39 months | ||||
ZEVALIN distribution rights [Member] | Ex-U.S. [Member] | |||||
Product Rights [Line Items] | |||||
Historical Cost | 23,490 | $ 23,490 | 23,490 | ||
Accumulated Amortization | (12,632) | (12,632) | (7,402) | ||
Foreign Currency Translation | (4,353) | (2,162) | |||
Impairment | 0 | ||||
Net Amount | 6,505 | $ 6,505 | 13,926 | ||
Full Amortization Period (months) | 96 months | ||||
Remaining Amortization Period (months) | 51 months | ||||
Accelerated amortization | 3,700 | ||||
FUSILEV distribution rights [Member] | |||||
Product Rights [Line Items] | |||||
Historical Cost | 16,778 | $ 16,778 | 16,778 | ||
Accumulated Amortization | (9,618) | (9,618) | (6,270) | ||
Impairment | (7,160) | ||||
Net Amount | 0 | $ 0 | 10,508 | ||
Full Amortization Period (months) | 56 months | ||||
Remaining Amortization Period (months) | 0 months | ||||
FOLOTYN out-License [Member] | |||||
Product Rights [Line Items] | |||||
Historical Cost | 27,900 | $ 27,900 | 27,900 | ||
Accumulated Amortization | (9,109) | (9,109) | (6,385) | ||
Impairment | (1,023) | (1,023) | |||
Net Amount | $ 17,768 | $ 17,768 | $ 20,492 | ||
Full Amortization Period (months) | 110 months | ||||
Remaining Amortization Period (months) | 79 months | ||||
Fusilev [Member] | |||||
Product Rights [Line Items] | |||||
Impairment | $ (7,200) |
Balance Sheet Account Detail 54
Balance Sheet Account Detail - Estimated Intangible Asset Amortization Expense (Detail) $ in Thousands | Dec. 31, 2015USD ($) |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
2,016 | $ 23,360 |
2,017 | 23,368 |
2,018 | 23,368 |
2,019 | 20,762 |
2,020 | 15,505 |
2021 and thereafter | 58,672 |
Total | $ 165,035 |
Balance Sheet Account Detail 55
Balance Sheet Account Detail - Schedule of Goodwill (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Goodwill [Line Items] | ||
Foreign currency exchange translation effects | $ (437) | $ (202) |
Goodwill | 17,960 | 18,195 |
ZEVALIN Ex-U.S. Distribution Rights [Member] | ||
Goodwill [Line Items] | ||
Acquisition | 2,525 | 2,525 |
Allos Therapeutics, Inc. [Member] | ||
Goodwill [Line Items] | ||
Acquisition | 5,346 | 5,346 |
Talon [Member] | ||
Goodwill [Line Items] | ||
Acquisition | $ 10,526 | $ 10,526 |
Balance Sheet Account Detail 56
Balance Sheet Account Detail - Summary of Other Assets (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Equity securities and secured promissory note (see Note 11) | $ 6,689 | $ 8,501 |
Supplies and deposits | 185 | 234 |
2018 Convertible Notes issuance costs (excluding current portion) | 1,472 | 2,171 |
Executive officer life insurance – cash surrender value | 9,181 | 6,958 |
(Less:) Non-current portion of inventories included within other assets | 3,156 | 0 |
Other assets | 20,683 | $ 17,864 |
Unrealized loss | $ 1,400 |
Balance Sheet Account Detail 57
Balance Sheet Account Detail - Schedule of Accounts Payable and Other Accrued Obligations (Detail) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Trade accounts payable and other accrueds | $ 26,684 | $ 24,571 |
Accrued rebates | 18,166 | 41,782 |
Accrued product royalty | 4,908 | 5,182 |
Allowance for returns | 1,394 | 1,135 |
Accrued data and distribution fees | 1,830 | 3,952 |
Accrued GPO administrative fees | 1,058 | 3,222 |
Inventory management fee | 498 | 1,110 |
Allowance for chargebacks | 2,001 | 4,040 |
Accounts payable and other accrueds | $ 56,539 | $ 84,994 |
Balance Sheet Account Detail 58
Balance Sheet Account Detail - Schedule of Amounts Presented in Accounts Payable and Other Accrued Obligations (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Rebates and Chargebacks [Member] | ||
Accounts Payable and Other Accrued Liabilities [Roll Forward] | ||
Beginning balance | $ 45,822 | $ 33,967 |
Add: provisions (recovery) | (75,498) | (76,636) |
(Less): credits or actual allowances | (101,153) | (64,781) |
Ending balance | 20,167 | 45,822 |
Data and Distribution, GPO Fees, and Inventory Management Fees [Member] | ||
Accounts Payable and Other Accrued Liabilities [Roll Forward] | ||
Beginning balance | 8,284 | 5,373 |
Add: provisions (recovery) | (15,928) | (21,330) |
(Less): credits or actual allowances | (20,826) | (18,419) |
Ending balance | 3,386 | 8,284 |
Returns [Member] | ||
Accounts Payable and Other Accrued Liabilities [Roll Forward] | ||
Beginning balance | 1,135 | 2,900 |
Add: provisions (recovery) | (1,486) | 78 |
(Less): credits or actual allowances | (1,227) | (1,687) |
Ending balance | $ 1,394 | $ 1,135 |
Balance Sheet Account Detail 59
Balance Sheet Account Detail - Deferred revenue (Details) - USD ($) $ in Thousands | 3 Months Ended | ||
Dec. 31, 2015 | Sep. 30, 2015 | Dec. 31, 2014 | |
Deferred Revenue Arrangement [Line Items] | |||
Deferred Revenue | $ 6,513 | $ 9,959 | |
CASI Out-License [Member] | |||
Deferred Revenue Arrangement [Line Items] | |||
Deferred Revenue | 0 | 9,959 | |
Fusilev [Member] | |||
Deferred Revenue Arrangement [Line Items] | |||
Deferred Revenue | 6,083 | $ 9,900 | 0 |
Product sales, net | 3,800 | ||
Dr. Reddy [Member] | |||
Deferred Revenue Arrangement [Line Items] | |||
Deferred Revenue | $ 430 | $ 0 |
Balance Sheet Account Detail 60
Balance Sheet Account Detail - Summary of Other Long-Term Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Accrued executive deferred compensation | $ 6,458 | $ 4,694 |
Deferred rent (non-current portion) | 248 | 364 |
Business acquisition liability | 0 | 300 |
Other tax liabilities | 738 | 730 |
Other long-term liabilities | $ 7,444 | $ 6,088 |
Gross-to-Net Product Sales - Re
Gross-to-Net Product Sales - Reconciliation of Gross-to-Net Product Sales (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Revenue, Net [Abstract] | |||
Gross product sales | $ 215,136 | $ 284,685 | $ 224,301 |
Commercial rebates and government chargebacks | (61,283) | (76,636) | (63,610) |
Distribution, data, and GPO administrative fees | (15,613) | (21,330) | (19,067) |
Prompt pay discounts | (16) | (260) | (183) |
Product returns allowances | (1,373) | 78 | 2,034 |
Product sales, net | $ 136,851 | $ 186,537 | $ 143,475 |
Net Product Sales by Geograph62
Net Product Sales by Geographic Region, Product Line, and Gross Product Sales by Significant Customers - Schedule of Net Product Sales by Geography (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Sales Information [Line Items] | |||
Net product sales | $ 136,851 | $ 186,537 | $ 143,475 |
ZEVALIN [Member] | |||
Sales Information [Line Items] | |||
Net product sales | 17,457 | 22,169 | 29,393 |
United States [Member] | |||
Sales Information [Line Items] | |||
Net product sales | 130,432 | 177,979 | 133,462 |
Total International [Member] | |||
Sales Information [Line Items] | |||
Net product sales | 6,419 | 8,558 | 10,013 |
Total International [Member] | Europe [Member] | ZEVALIN [Member] | |||
Sales Information [Line Items] | |||
Net product sales | 2,234 | 3,357 | 3,953 |
Total International [Member] | Asia Pacific [Member] | ZEVALIN [Member] | |||
Sales Information [Line Items] | |||
Net product sales | $ 4,185 | $ 5,201 | $ 6,060 |
Geographic Concentration Risk [Member] | Sales [Member] | |||
Sales Information [Line Items] | |||
Percentage of net product sales | 100.00% | 100.00% | 100.00% |
Geographic Concentration Risk [Member] | Sales [Member] | United States [Member] | |||
Sales Information [Line Items] | |||
Percentage of net product sales | 95.30% | 95.40% | 93.00% |
Geographic Concentration Risk [Member] | Sales [Member] | Total International [Member] | |||
Sales Information [Line Items] | |||
Percentage of net product sales | 4.70% | 4.60% | 7.00% |
Geographic Concentration Risk [Member] | Sales [Member] | Total International [Member] | Europe [Member] | ZEVALIN [Member] | |||
Sales Information [Line Items] | |||
Percentage of net product sales | 1.60% | 1.80% | 2.80% |
Geographic Concentration Risk [Member] | Sales [Member] | Total International [Member] | Asia Pacific [Member] | ZEVALIN [Member] | |||
Sales Information [Line Items] | |||
Percentage of net product sales | 3.10% | 2.80% | 4.20% |
Net Product Sales by Geograph63
Net Product Sales by Geographic Region, Product Line, and Gross Product Sales by Significant Customers - Schedule of Net Product Sales by Product Line (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Sales Information [Line Items] | |||
Net product sales | $ 136,851 | $ 186,537 | $ 143,475 |
Fusilev [Member] | |||
Sales Information [Line Items] | |||
Net product sales | 60,710 | 105,608 | 68,397 |
FOLOTYN [Member] | |||
Sales Information [Line Items] | |||
Net product sales | 40,606 | 47,556 | 44,370 |
ZEVALIN [Member] | |||
Sales Information [Line Items] | |||
Net product sales | 17,457 | 22,169 | 29,393 |
MARQIBO [Member] | |||
Sales Information [Line Items] | |||
Net product sales | 8,006 | 6,328 | 1,315 |
BELEODAQ [Member] | |||
Sales Information [Line Items] | |||
Net product sales | $ 10,072 | $ 4,876 | $ 0 |
Product Concentration Risk [Member] | Sales [Member] | |||
Sales Information [Line Items] | |||
Percentage of net product sales | 100.00% | 100.00% | 100.00% |
Product Concentration Risk [Member] | Sales [Member] | Fusilev [Member] | |||
Sales Information [Line Items] | |||
Percentage of net product sales | 44.40% | 56.60% | 47.70% |
Product Concentration Risk [Member] | Sales [Member] | FOLOTYN [Member] | |||
Sales Information [Line Items] | |||
Percentage of net product sales | 29.70% | 25.50% | 30.90% |
Product Concentration Risk [Member] | Sales [Member] | ZEVALIN [Member] | |||
Sales Information [Line Items] | |||
Percentage of net product sales | 12.80% | 11.90% | 20.50% |
Product Concentration Risk [Member] | Sales [Member] | MARQIBO [Member] | |||
Sales Information [Line Items] | |||
Percentage of net product sales | 5.90% | 3.40% | 0.90% |
Product Concentration Risk [Member] | Sales [Member] | BELEODAQ [Member] | |||
Sales Information [Line Items] | |||
Percentage of net product sales | 7.40% | 2.60% | 0.00% |
Net Product Sales by Geograph64
Net Product Sales by Geographic Region, Product Line, and Gross Product Sales by Significant Customers - Summary of Customers Representing 10% or More of Gross Product Sales (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Revenue, Major Customer [Line Items] | |||
Gross product sales | $ 215,136 | $ 284,685 | $ 224,301 |
Oncology Supply, a division of ASD Specialty Healthcare, Inc., and its affiliates (excluding ICS) [Member] | |||
Revenue, Major Customer [Line Items] | |||
Gross product sales | 78,989 | 115,079 | 79,497 |
McKesson Corporation and its affiliates [Member] | |||
Revenue, Major Customer [Line Items] | |||
Gross product sales | 73,577 | 93,656 | 44,350 |
Integrated Commercialization Solutions, Inc. (ICS) [Member] | |||
Revenue, Major Customer [Line Items] | |||
Gross product sales | 35,548 | ||
Cardinal Health, Inc. and its affiliates [Member] | |||
Revenue, Major Customer [Line Items] | |||
Gross product sales | 37,414 | ||
All Other Customers [Member] | |||
Revenue, Major Customer [Line Items] | |||
Gross product sales | $ 25,156 | $ 75,950 | $ 64,906 |
Customer Concentration Risk [Member] | Gross Product Sales [Member] | |||
Revenue, Major Customer [Line Items] | |||
Percentage of gross product sales | 100.00% | 100.00% | 100.00% |
Customer Concentration Risk [Member] | Gross Product Sales [Member] | Oncology Supply, a division of ASD Specialty Healthcare, Inc., and its affiliates (excluding ICS) [Member] | |||
Revenue, Major Customer [Line Items] | |||
Percentage of gross product sales | 36.70% | 40.40% | 35.40% |
Customer Concentration Risk [Member] | Gross Product Sales [Member] | McKesson Corporation and its affiliates [Member] | |||
Revenue, Major Customer [Line Items] | |||
Percentage of gross product sales | 34.20% | 32.90% | 19.80% |
Customer Concentration Risk [Member] | Gross Product Sales [Member] | Integrated Commercialization Solutions, Inc. (ICS) [Member] | |||
Revenue, Major Customer [Line Items] | |||
Percentage of gross product sales | 0.00% | 0.00% | 15.80% |
Customer Concentration Risk [Member] | Gross Product Sales [Member] | Cardinal Health, Inc. and its affiliates [Member] | |||
Revenue, Major Customer [Line Items] | |||
Percentage of gross product sales | 17.40% | 0.00% | 0.00% |
Customer Concentration Risk [Member] | Gross Product Sales [Member] | All Other Customers [Member] | |||
Revenue, Major Customer [Line Items] | |||
Percentage of gross product sales | 11.70% | 26.70% | 29.00% |
Customer Concentration Risk [Member] | Gross Product Sales [Member] | Maximum [Member] | Integrated Commercialization Solutions, Inc. (ICS) [Member] | |||
Revenue, Major Customer [Line Items] | |||
Percentage of gross product sales | 10.00% | ||
Customer Concentration Risk [Member] | Gross Product Sales [Member] | Maximum [Member] | Cardinal Health, Inc. and its affiliates [Member] | |||
Revenue, Major Customer [Line Items] | |||
Percentage of gross product sales | 10.00% | 10.00% |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) | 12 Months Ended | ||
Dec. 31, 2015USD ($)Plansshares | Dec. 31, 2014 | Dec. 31, 2013 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of stock incentive plans | Plans | 1 | ||
Estimated forfeiture rate | 11.00% | 8.00% | 8.00% |
Exercise of Issued Employee Stock Option [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Unrecognized compensation expense | $ | $ 8,800,000 | ||
Weighted average period to recognize compensation expense | 2 years 4 months 29 days | ||
Restricted Stock Awards [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Unrecognized compensation expense | $ | $ 9,800,000 | ||
Weighted average period to recognize compensation expense | 2 years 3 months 13 days | ||
Upon Termination of Employment [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock based award vest | 25.00% | ||
Restricted stock exercised period | 90 days | ||
In the Event of Optionee's Death, Disability or Retirement [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Restricted stock exercised period | 365 days | ||
Maximum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Restricted stock vesting period | 10 years | ||
Minimum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Restricted stock vesting period | 3 years | ||
2009 Incentive Award Plan [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Common stock authorized for issuance under incentive plan (shares) | 10,000,000 | ||
Increased number of common stock shares (shares) | 2,500,000 | ||
Issuance of common stock | 30.00% | ||
Incentive awards available for grant (shares) | 8,641,698 | ||
2009 Incentive Award Plan [Member] | Maximum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Exercise price fair value | 100.00% | ||
2013 Stock Incentive Plan [Member] | Maximum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Incentive awards available for grant (shares) | 50,000 | ||
Purchase Plan [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Common stock authorized for issuance under incentive plan (shares) | 4,300,000 | ||
Incentive awards available for grant (shares) | 10,000,000 | ||
Percentage of common stock purchase price | 15.00% | ||
Purchase Plan offering period | 6 months | ||
Maximum number of common stock shares available for purchase per participant (shares) | 50,000 | ||
Maximum number of common stock value available for purchase per participant | $ | $ 25,000 | ||
Increase in number of shares of common stock available for issuance under the purchase plan (shares) | 1,000,000 |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock-Based Compensation Expense (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Total share-based compensation expense | $ 12,084 | $ 11,809 | $ 12,779 |
Cost of product sales [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Total share-based compensation expense | 62 | 0 | 0 |
Selling, general and administrative [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Total share-based compensation expense | 10,049 | 10,053 | 10,762 |
Research and development [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Total share-based compensation expense | $ 1,973 | $ 1,756 | $ 2,017 |
Stock-Based Compensation - Fair
Stock-Based Compensation - Fair Value of Stock Options Granted Using Black-Scholes Option Pricing Model (Detail) - $ / shares | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected option life (in years) | 5 years 5 months 6 days | 4 years 11 months 12 days | 4 years 11 months 12 days |
Risk-free interest rate, Minimum | 1.25% | 0.58% | 0.35% |
Risk-free interest rate, Maximum | 1.68% | 1.52% | 0.78% |
Volatility, Minimum | 48.00% | 48.90% | 58.30% |
Volatility, Maximum | 52.00% | 62.10% | 71.50% |
Dividend yield | 0.00% | 0.00% | 0.00% |
Weighted-average grant-date fair value per stock option ($ per share) | $ 2.85 | $ 3.49 | $ 4.66 |
Maximum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected option life (in years) | 10 years | 10 years | 10 years |
Stock-Based Compensation - Su68
Stock-Based Compensation - Summary of Stock Option Activity (Detail) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Number of Shares | |||
Outstanding, beginning | 12,649,102 | 11,329,218 | 10,399,265 |
Granted | 2,219,587 | 2,576,292 | 2,041,300 |
Exercised | (456,082) | (485,260) | (825,884) |
Forfeited | (296,162) | (557,109) | (202,882) |
Expired | (279,594) | (214,039) | (82,581) |
Outstanding, ending | 13,836,851 | 12,649,102 | 11,329,218 |
Vested (exercisable) — December 31, 2015 | 10,235,721 | ||
Unvested (unexercisable) — December 31, 2015 | 3,601,130 | ||
Weighted- Average Exercise Price/Share | |||
Outstanding, beginning | $ 7.12 | $ 7.10 | $ 6.57 |
Granted | 6.04 | 7.60 | 8.92 |
Exercised | 4.45 | 4.77 | 4.40 |
Forfeited | 8.06 | 9.65 | 8.22 |
Expired | 9.05 | 10.70 | 8.91 |
Outstanding, ending | 6.97 | $ 7.12 | $ 7.10 |
Vested (exercisable) — December 31, 2015 | 6.94 | ||
Unvested (unexercisable) — December 31, 2015 | $ 7.06 | ||
Weighted-Average Remaining Contractual Term (Years), Outstanding | 6 years 4 months 4 days | ||
Weighted-Average Remaining Contractual Term (Years), Vested (exercisable) | 5 years 4 months 25 days | ||
Weighted-Average Remaining Contractual Term (Years), Unvested (unexercisable) | 9 years 1 day | ||
Stock options exercised, Intrinsic value | $ 977 | $ 1,629 | $ 3,435 |
Outstanding, Aggregate Intrinsic Value | 7,516 | ||
Aggregate Intrinsic Value, Vested (exercisable) | 7,159 | ||
Aggregate Intrinsic Value, Unvested (unexercisable) | $ 357 |
Stock-Based Compensation - Su69
Stock-Based Compensation - Summary of Stock Option Grants (Detail) | 12 Months Ended |
Dec. 31, 2015$ / sharesshares | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Granted Stock Options Outstanding (shares) | shares | 13,836,851 |
Weighted- Average Remaining Contractual Life (Years) | 6 years 4 months 2 days |
Weighted-Average Exercise Price ($ per share) | $ 6.97 |
Granted Stock Options Exercisable (shares) | shares | 10,235,721 |
Weighted-Average Exercise Price ($ per share) | $ 6.94 |
$0.92 - 3.15 | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Exercise Price, Range lower limit | 0.92 |
Exercise Price, Range upper limit | $ 3.15 |
Granted Stock Options Outstanding (shares) | shares | 1,090,385 |
Weighted- Average Remaining Contractual Life (Years) | 2 years 5 months 28 days |
Weighted-Average Exercise Price ($ per share) | $ 2.18 |
Granted Stock Options Exercisable (shares) | shares | 1,090,385 |
Weighted-Average Exercise Price ($ per share) | $ 2.18 |
$3.16 - 4.95 | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Exercise Price, Range lower limit | 3.16 |
Exercise Price, Range upper limit | $ 4.95 |
Granted Stock Options Outstanding (shares) | shares | 1,378,444 |
Weighted- Average Remaining Contractual Life (Years) | 4 years 3 months 16 days |
Weighted-Average Exercise Price ($ per share) | $ 4.24 |
Granted Stock Options Exercisable (shares) | shares | 1,378,444 |
Weighted-Average Exercise Price ($ per share) | $ 4.24 |
$4.96 - 6.9 | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Exercise Price, Range lower limit | 4.96 |
Exercise Price, Range upper limit | $ 6.90 |
Granted Stock Options Outstanding (shares) | shares | 4,394,294 |
Weighted- Average Remaining Contractual Life (Years) | 6 years 1 month 20 days |
Weighted-Average Exercise Price ($ per share) | $ 6.08 |
Granted Stock Options Exercisable (shares) | shares | 2,999,511 |
Weighted-Average Exercise Price ($ per share) | $ 6.22 |
$6.91 - 8.99 | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Exercise Price, Range lower limit | 6.91 |
Exercise Price, Range upper limit | $ 8.99 |
Granted Stock Options Outstanding (shares) | shares | 4,500,895 |
Weighted- Average Remaining Contractual Life (Years) | 7 years 7 months 10 days |
Weighted-Average Exercise Price ($ per share) | $ 7.78 |
Granted Stock Options Exercisable (shares) | shares | 2,595,943 |
Weighted-Average Exercise Price ($ per share) | $ 7.95 |
$9.00 - 16.32 | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Exercise Price, Range lower limit | 9 |
Exercise Price, Range upper limit | $ 16.32 |
Granted Stock Options Outstanding (shares) | shares | 2,472,833 |
Weighted- Average Remaining Contractual Life (Years) | 7 years 2 months 14 days |
Weighted-Average Exercise Price ($ per share) | $ 10.71 |
Granted Stock Options Exercisable (shares) | shares | 2,171,438 |
Weighted-Average Exercise Price ($ per share) | $ 10.83 |
Stock-Based Compensation - Su70
Stock-Based Compensation - Summary of Restricted Stock Activity (Detail) - $ / shares | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Number of Restricted Stock Awards | |||
Unvested, Beginning Balance | 824,217 | 1,007,119 | 1,034,604 |
Granted | 1,948,585 | 581,194 | 523,800 |
Vested | (364,507) | (578,985) | (501,660) |
Forfeited | (234,313) | (185,111) | (49,625) |
Unvested, Ending Balance | 2,173,982 | 824,217 | 1,007,119 |
Weighted Average Fair Value per Share at Grant Date | |||
Beginning Balance | $ 8.22 | $ 10.09 | $ 11 |
Granted | 6.32 | 7.52 | 8.74 |
Vested | 8.47 | 10.24 | 9.72 |
Forfeited | 7.32 | 9.88 | 10.60 |
Ending Balance | $ 6.58 | $ 8.22 | $ 10.09 |
Stock-Based Compensation - Fa71
Stock-Based Compensation - Fair Value of Restricted Stock Awards (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |||
Restricted stock expense | $ 4,006 | $ 3,830 | $ 4,202 |
Stock-Based Compensation - Issu
Stock-Based Compensation - Issued Shares of Common Stock (Detail) - 401(k) Plan [Member] - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Shares of common stock issued (shares) | 179,865 | 133,734 | 99,359 |
Match contribution value | $ 1,124 | $ 1,028 | $ 860 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) | 1 Months Ended | 12 Months Ended | |||
Sep. 30, 2003USD ($)$ / sharesshares | Dec. 31, 2015shares | Dec. 31, 2014shares | Jun. 13, 2011shares | Dec. 13, 2010shares | |
Schedule Of Share Based Compensation Arrangements By Share Based Payment Award Options [Line Items] | |||||
Preferred stock, shares authorized (shares) | 5,000,000 | 5,000,000 | |||
Number of common shares authorized | 175,000,000 | 175,000,000 | |||
New replacement rights agreement extended date | December 13, 2020 | ||||
Threshold to exercise rights after designated events | 10 days | ||||
Percentage of outstanding shares acquired to exercise preferred share rights | 15.00% | ||||
Waiting period after rights activated | 5 days | ||||
Right to purchase shares | 2 | ||||
Transfer of assets or earnings power | 50.00% | ||||
Common stock trading price per share ($ per share) | $ / shares | $ 12 | ||||
Percentage of preferred stock liquidation preference common stock | 120.00% | ||||
Shares of common stock issuable upon conversion or exercise of rights granted (shares) | 26,000,000 | ||||
Outstanding warrants expire on varying dates | December 2,020 | ||||
Minimum [Member] | |||||
Schedule Of Share Based Compensation Arrangements By Share Based Payment Award Options [Line Items] | |||||
Number of common shares authorized | 100,000,000 | ||||
Maximum [Member] | |||||
Schedule Of Share Based Compensation Arrangements By Share Based Payment Award Options [Line Items] | |||||
Number of common shares authorized | 175,000,000 | ||||
Series B Junior Participating Preferred Stock [Member] | |||||
Schedule Of Share Based Compensation Arrangements By Share Based Payment Award Options [Line Items] | |||||
Preferred stock, shares authorized (shares) | 1,500,000 | 1,500,000 | 1,500,000 | ||
Preferred stock issued (shares) | 0 | 0 | |||
Convertible preferred stock outstanding (shares) | 0 | 0 | |||
Series E Convertible Voting Preferred Stock [Member] | |||||
Schedule Of Share Based Compensation Arrangements By Share Based Payment Award Options [Line Items] | |||||
Preferred stock, shares authorized (shares) | 2,000 | 2,000 | |||
Preferred stock issued (shares) | 2,000 | 20 | 20 | ||
Cash proceeds from exchange of preferred stock | $ | $ 20,000,000 | ||||
Preferred stock converted into common stock (shares) | 4,000,000 | 40,000 | 40,000 | ||
Convertible preferred stock outstanding (shares) | 20 | 20 | |||
Dividends payable | $ | $ 0 | ||||
Number of trading days consider for option to redeem preferred stock | 20 days |
Stockholders' Equity - Shares o
Stockholders' Equity - Shares of Common Stock Issuable on Conversion or Exercise of Rights Granted (Detail) | Dec. 31, 2015shares |
Schedule Of Share Based Compensation Arrangements By Share Based Payment Award Options [Line Items] | |
Total common shares | 25,983,135 |
Exercise of Issued Warrants [Member] | |
Schedule Of Share Based Compensation Arrangements By Share Based Payment Award Options [Line Items] | |
Total common shares | 445,000 |
2018 Convertible Notes [Member] | |
Schedule Of Share Based Compensation Arrangements By Share Based Payment Award Options [Line Items] | |
Total common shares | 11,401,284 |
Employee Stock Option [Member] | |
Schedule Of Share Based Compensation Arrangements By Share Based Payment Award Options [Line Items] | |
Total common shares | 13,836,851 |
Management Incentive Plan Restricted Stock Units [Member] | |
Schedule Of Share Based Compensation Arrangements By Share Based Payment Award Options [Line Items] | |
Total common shares | 260,000 |
Series E Convertible Voting Preferred Stock [Member] | |
Schedule Of Share Based Compensation Arrangements By Share Based Payment Award Options [Line Items] | |
Total common shares | 40,000 |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Warrant Activity (Detail) - $ / shares | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Share-based Compensation Arrangement by Share-based Payment Award, Non-Option Equity Instruments, Outstanding [Roll Forward] | |||
Weighted Average Exercise Price, Beginning Balance ($ per share) | $ 6.39 | $ 6.39 | $ 5.45 |
Weighted Average Exercise Price, Granted ($ per share) | 7.51 | ||
Weighted Average Exercise Price, Granted ($ per share) | 0 | 0 | |
Weighted Average Exercise Price, Ending Balance ($ per share) | 6.78 | $ 6.39 | $ 6.39 |
Weighted Average Exercise Price, Exercisable ($ per share) | $ 6.78 | ||
Exercise of Issued Warrants [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Non-Option Equity Instruments, Outstanding [Roll Forward] | |||
Number of shares, outstanding beginning | 445,000 | 445,000 | 395,000 |
Number of shares, granted | 0 | 50,000 | |
Number of shares, granted | 0 | ||
Number of shares, outstanding ending balance | 445,000 | 445,000 | 445,000 |
Number of shares, exerciseable | 445,000 |
Net Loss Per Share - Computatio
Net Loss Per Share - Computation of Net (Loss) Income Per Share (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Earnings Per Share [Abstract] | |||||||||||
Net loss | $ (4,153) | $ (18,724) | $ (2,346) | $ (25,562) | $ (2,976) | $ (11,539) | $ (3,563) | $ (27,641) | $ (50,785) | $ (45,719) | $ (62,134) |
Weighted average shares-basic (shares) | 64,882,417 | 64,708,163 | 60,729,128 | ||||||||
Net (loss) income per share-basic ($ per share) | $ (0.07) | $ (0.28) | $ (0.04) | $ (0.39) | $ (0.05) | $ (0.18) | $ (0.06) | $ (0.44) | $ (0.78) | $ (0.71) | $ (1.02) |
Weighted average shares-diluted (shares) | 64,882,417 | 64,708,163 | 60,729,128 | ||||||||
Net (loss) income per share-diluted ($ per share) | $ (0.07) | $ (0.28) | $ (0.04) | $ (0.39) | $ (0.05) | $ (0.18) | $ (0.06) | $ (0.44) | $ (0.78) | $ (0.71) | $ (1.02) |
Net Loss Per Share - Schedule o
Net Loss Per Share - Schedule of Securities Excluded from Calculation of Net (Loss) per Share (Detail) - shares | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Anti-dilutive excluded from computation of earnings per share amount | 15,065,342 | 14,560,119 | 4,486,160 |
Preferred Stock [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Anti-dilutive excluded from computation of earnings per share amount | 40,000 | 40,000 | 40,000 |
Common Stock Warrants [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Anti-dilutive excluded from computation of earnings per share amount | 9,357 | 120,702 | 160,816 |
2018 Convertible Notes [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Anti-dilutive excluded from computation of earnings per share amount | 11,401,284 | 11,401,284 | 343,600 |
Common Stock Options [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Anti-dilutive excluded from computation of earnings per share amount | 1,441,086 | 2,173,916 | 2,934,625 |
Restricted Stock Awards [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Anti-dilutive excluded from computation of earnings per share amount | 2,173,615 | 824,217 | 1,007,119 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Asset and Liability Fair Values (Detail) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Assets: | ||
Deferred compensation investments, including life insurance cash surrender value | $ 9,181 | $ 6,958 |
Total Assets | 94,731 | 84,400 |
Liabilities: | ||
Deferred executive compensation liability | 6,458 | 4,694 |
Deferred drug development liability | 14,686 | 15,785 |
Ligand Contingent Consideration | 5,227 | 4,901 |
Talon CVR | 1,377 | 2,379 |
Corixa Liability | 62 | 62 |
Financial and Nonfinancial Liabilities, Fair Value Disclosure | 27,810 | 27,821 |
Bank CDs [Member] | ||
Assets: | ||
Marketable securities, fair value | 245 | 244 |
Money Market Funds [Member] | ||
Assets: | ||
Marketable securities, fair value | 80,116 | 66,945 |
Equity Securities [Member] | ||
Assets: | ||
Marketable securities, fair value | 5,189 | 7,191 |
Mutual Funds [Member] | ||
Assets: | ||
Marketable securities, fair value | 0 | 3,062 |
Level 1 [Member] | ||
Assets: | ||
Total Assets | 5,189 | 7,191 |
Level 1 [Member] | Equity Securities [Member] | ||
Assets: | ||
Marketable securities, fair value | 5,189 | 7,191 |
Level 2 [Member] | ||
Assets: | ||
Deferred compensation investments, including life insurance cash surrender value | 9,181 | 6,958 |
Total Assets | 89,542 | 77,209 |
Liabilities: | ||
Deferred executive compensation liability | 6,458 | 4,694 |
Financial and Nonfinancial Liabilities, Fair Value Disclosure | 6,458 | 4,694 |
Level 2 [Member] | Bank CDs [Member] | ||
Assets: | ||
Marketable securities, fair value | 245 | 244 |
Level 2 [Member] | Money Market Funds [Member] | ||
Assets: | ||
Marketable securities, fair value | 80,116 | 66,945 |
Level 2 [Member] | Mutual Funds [Member] | ||
Assets: | ||
Marketable securities, fair value | 0 | 3,062 |
Level 3 [Member] | ||
Liabilities: | ||
Deferred drug development liability | 14,686 | 15,785 |
Ligand Contingent Consideration | 5,227 | 4,901 |
Talon CVR | 1,377 | 2,379 |
Corixa Liability | 62 | 62 |
Financial and Nonfinancial Liabilities, Fair Value Disclosure | $ 21,352 | $ 23,127 |
Fair Value Measurements - Activ
Fair Value Measurements - Activity of Level 3 Inputs Measured on Recurring Basis (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Beginning Balance | $ 23,127 | $ 26,071 |
Ending Balance | 21,352 | 23,127 |
Deferred Development Costs [Member] | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Transfers in (out) of Level 3 | (1,099) | (1,957) |
Ligand Contingent Consideration [Member] | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Transfers in (out) of Level 3 | 326 | 901 |
Talon CVR [Member] | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Transfers in (out) of Level 3 | (1,002) | (1,950) |
Corixa Liability [Member] | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Transfers in (out) of Level 3 | $ 0 | $ 62 |
Business Combinations and Con80
Business Combinations and Contingent Consideration - Additional Information (Detail) - USD ($) $ / shares in Units, shares in Millions | Mar. 10, 2016 | Jul. 17, 2013 | Mar. 31, 2013 | Dec. 31, 2015 | Dec. 31, 2014 | Jul. 31, 2013 | Sep. 05, 2012 |
Business Acquisition [Line Items] | |||||||
License fees received | $ 3,000,000 | ||||||
Royalties payout percentage on our future net sales of licensed products | 20.00% | ||||||
Ligand Contingent Consideration | $ 5,227,000 | $ 4,901,000 | |||||
IPR&D [Member] | |||||||
Business Acquisition [Line Items] | |||||||
Estimated cash flow period | 10 years | ||||||
Estimated cash flow discount rate | 25.00% | ||||||
Milestone Payments [Member] | |||||||
Business Acquisition [Line Items] | |||||||
Milestone net sales achievement | $ 5,000,000 | $ 66,000,000 | |||||
Milestone net sales achievement | 30,000,000 | ||||||
Ligand Contingent Consideration | $ 6,000,000 | ||||||
Milestone Payment One [Member] | |||||||
Business Acquisition [Line Items] | |||||||
Milestone net sales achievement | 10,000,000 | ||||||
Milestone net sales achievement | 60,000,000 | ||||||
Milestone Payment Two [Member] | |||||||
Business Acquisition [Line Items] | |||||||
Milestone net sales achievement | 25,000,000 | ||||||
Milestone net sales achievement | 100,000,000 | ||||||
Milestone Payment Three [Member] | |||||||
Business Acquisition [Line Items] | |||||||
Milestone net sales achievement | 50,000,000 | ||||||
Milestone net sales achievement | 200,000,000 | ||||||
Milestone Payment Four [Member] | |||||||
Business Acquisition [Line Items] | |||||||
Milestone net sales achievement | 100,000,000 | ||||||
Milestone net sales achievement | 400,000,000 | ||||||
Menadione Topical Lotion [Member] | |||||||
Business Acquisition [Line Items] | |||||||
Milestone net sales achievement | 5,000,000 | ||||||
Talon Therapeutics, Inc. [Member] | |||||||
Business Acquisition [Line Items] | |||||||
Additional shares business acquisition date | Jul. 17, 2013 | ||||||
Cash consideration | $ 11,300,000 | ||||||
Shares issued in acquisition (shares) | 3 | ||||||
Common stock value assigned | $ 26,300,000 | ||||||
Common stock value, per share ($ per share) | $ 8.77 | ||||||
Estimated fair value of acquisition | $ 6,500,000 | ||||||
Contingent value rights future cash payments | $ 195,000,000 | $ 195,000,000 | |||||
Talon Therapeutics, Inc. [Member] | Minimum [Member] | |||||||
Business Acquisition [Line Items] | |||||||
Contingent value rights expected rate | 50.00% | ||||||
Talon Therapeutics, Inc. [Member] | Maximum [Member] | |||||||
Business Acquisition [Line Items] | |||||||
Contingent value rights expected rate | 100.00% | ||||||
Allos Therapeutics, Inc. [Member] | |||||||
Business Acquisition [Line Items] | |||||||
Ligand Contingent Consideration | $ 0 | ||||||
Total purchase consideration | $ 205,200,000 | ||||||
Subsequent Event [Member] | |||||||
Business Acquisition [Line Items] | |||||||
Payment period | 30 days | ||||||
Subsequent Event [Member] | Milestone Payments [Member] | |||||||
Business Acquisition [Line Items] | |||||||
Ligand Contingent Consideration | $ 6,000,000 |
Business Combinations and Con81
Business Combinations and Contingent Consideration - Change in Fair Value of Contingent Consideration Related to Acquisitions (Detail) $ in Thousands | 12 Months Ended |
Dec. 31, 2015USD ($) | |
Talon Therapeutics, Inc. [Member] | |
Change in Fair Value of Contingent Consideration [Roll Forward] | |
Fair value, Beginning Balance | $ 2,379 |
Fair value adjustment for the year ended December 31, 2015 | (1,002) |
Fair value, Ending Balance | 1,377 |
Ligand Pharmaceuticals Inc [Member] | |
Change in Fair Value of Contingent Consideration [Roll Forward] | |
Fair value, Beginning Balance | 4,901 |
Fair value adjustment for the year ended December 31, 2015 | 326 |
Fair value, Ending Balance | $ 5,227 |
Business Combinations and Con82
Business Combinations and Contingent Consideration - Acquisition-Date Fair Value of Consideration Transferred (Detail) - USD ($) $ in Thousands | 1 Months Ended | ||
Mar. 31, 2013 | Dec. 31, 2015 | Dec. 31, 2014 | |
Business Acquisition [Line Items] | |||
Ligand Contingent Consideration | $ 5,227 | $ 4,901 | |
Captisol-enabled, propylene glycol-free melphalan rights [Member] | |||
Business Acquisition [Line Items] | |||
Cash consideration | $ 3,000 | ||
Ligand Contingent Consideration | 4,700 | ||
Total purchase consideration | $ 7,700 |
Business Combinations and Con83
Business Combinations and Contingent Consideration - Summary of Allocation of Total Purchase Price to Net Assets Acquired (Detail) - Captisol-enabled, propylene glycol-free melphalan rights [Member] $ in Thousands | Mar. 31, 2013USD ($) |
Business Acquisition [Line Items] | |
Total purchase consideration | $ 7,700 |
IPR&D [Member] | |
Business Acquisition [Line Items] | |
Total purchase consideration | $ 7,700 |
Out-License of Marqibo, Zeval84
Out-License of Marqibo, Zevalin, & Evolmela in China Territory - Additional Information (Detail) $ in Thousands | Sep. 17, 2014productagreement | Dec. 31, 2015USD ($)product | Jun. 30, 2015USD ($) | Dec. 31, 2014USD ($) |
Other Commitments [Line Items] | ||||
Number of products | product | 6 | |||
License fees and service revenue to be recognized | $ | $ 6,513 | $ 9,959 | ||
CASI Out-License [Member] | ||||
Other Commitments [Line Items] | ||||
Number of agreements | agreement | 3 | |||
Number of products | product | 2 | |||
License agreement expiration date | Sep. 17, 2019 | |||
License fees and service revenue to be recognized | $ | $ 9,700 |
Out-License of Marqibo, Zeval85
Out-License of Marqibo, Zevalin, & Evolmela in China Territory - Schedule of Proceeds Received and Fair Value on CASI Out-License Execution Date (Detail) - USD ($) $ / shares in Units, $ in Thousands, shares in Millions | Sep. 17, 2014 | Dec. 31, 2015 |
Secured Promissory Note Due March 17, 2016 [Member] | ||
Other Commitments [Line Items] | ||
Debt instrument face value | $ 1,500 | |
CASI Out-License [Member] | ||
Other Commitments [Line Items] | ||
Total consideration received | $ 9,959 | |
Shares received (shares) | 5.4 | |
Stock price on the NASDAQ Capital Market ($ per share) | $ 1.6 | |
CASI Out-License [Member] | Secured Promissory Note Due March 17, 2016 [Member] | ||
Other Commitments [Line Items] | ||
Total consideration received | $ 1,310 | |
Debt instrument coupon rate | 0.50% | |
CASI Out-License [Member] | Common Stock [Member] | ||
Other Commitments [Line Items] | ||
Total consideration received | $ 8,649 | |
Other Assets [Member] | CASI Out-License [Member] | Common Stock [Member] | ||
Other Commitments [Line Items] | ||
Value of securities | $ 5,200 |
Out-License of Zevalin in Cer86
Out-License of Zevalin in Certain Ex-U.S. Territories (Details) $ in Millions | Nov. 16, 2015USD ($) |
Mundipharma [Member] | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |
Proceeds from sale of Spectrum GK | $ 2.2 |
ZEVALIN Ex-U.S. Distribution Rights [Member] | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |
Potential payment | 2 |
Payment One [Member] | ZEVALIN Ex-U.S. Distribution Rights [Member] | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |
Total consideration received | 15 |
Payment Two [Member] | ZEVALIN Ex-U.S. Distribution Rights [Member] | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |
Total consideration received | 3 |
Total Consideration [Member] | ZEVALIN Ex-U.S. Distribution Rights [Member] | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |
Total consideration received | $ 18 |
Co-Promotion Arrangement With87
Co-Promotion Arrangement With Eagle Pharmaceuticals, Inc. (Details) $ in Millions | Nov. 04, 2015USD ($)product | Jun. 30, 2017USD ($) | Dec. 31, 2016USD ($) | Dec. 31, 2015product |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Number of products | product | 6 | |||
Collaborative Arrangement, Co-promotion [Member] | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Number of products | product | 6 | |||
Term of arrangement | 18 months | |||
Value of agreement | $ | $ 12.8 | |||
Extension term | 6 months | |||
Termination notice | 60 days | |||
Maximum [Member] | Scenario, Forecast [Member] | Collaborative Arrangement, Co-promotion [Member] | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Milestone net sales achievement | $ | $ 4 | $ 5 |
Revolving Line of Credit - Addi
Revolving Line of Credit - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | Sep. 05, 2012 | |
Debt Disclosure [Abstract] | ||||
Credit agreement revolving line of credit facility | $ 50,000 | |||
Interest expense | $ 3,300 | $ 3,227 | $ 1,200 |
Convertible Senior Notes - Addi
Convertible Senior Notes - Additional Information (Detail) - USD ($) | Dec. 17, 2013 | Dec. 31, 2015 | Dec. 31, 2014 |
2018 Convertible Notes [Member] | |||
Debt Disclosure [Line Items] | |||
Estimated aggregate fair value | $ 105,100,000 | $ 113,200,000 | |
Principal amount | $ 120,000,000 | ||
2.75% Convertible Senior Notes Due 2018 [Member] | |||
Debt Disclosure [Line Items] | |||
Sale of convertible notes, principal amount | $ 120,000,000 | ||
Interest rate | 2.75% | ||
Conversion rate (shares) | 95 | ||
Conversion rate, price per $1,000 | $ 1,000 | ||
Common shares converted value (shares) | 11,400,000 | ||
Money conversion price per share ($ per share) | $ 10.53 | ||
Convertible senior notes maturity date | Dec. 15, 2018 | ||
Net proceeds from convertible notes | 115,400,000 | ||
Professional fee | $ 4,600,000 | ||
Additional paid-in capital | $ 13,100,000 | ||
Strike price per share ($ per share) | $ 14.03 | ||
Threshold percentage of conversion price | 130.00% | ||
Convertible senior notes trading price | $ 1,000 | ||
Percentage of product of last reported sale price of common stock | 98.00% | ||
2.75% Convertible Senior Notes Due 2018 [Member] | Minimum [Member] | |||
Debt Disclosure [Line Items] | |||
Debt convertible trading days | 20 days | ||
Debt convertible consecutive trading days | 5 days | ||
2.75% Convertible Senior Notes Due 2018 [Member] | Maximum [Member] | |||
Debt Disclosure [Line Items] | |||
Debt convertible consecutive trading days | 30 days |
Convertible Senior Notes - Carr
Convertible Senior Notes - Carrying Value of 2018 Convertible Notes (Detail) - 2018 Convertible Notes [Member] $ in Thousands | Dec. 31, 2015USD ($) |
Debt Instrument [Line Items] | |
Principal amount | $ 120,000 |
(Less): Unamortized debt discount (amortized through December 2018) | (18,452) |
December 31, 2015 | $ 101,548 |
Convertible Senior Notes - Comp
Convertible Senior Notes - Components of Total Interest Expense, Net Recognized (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Debt Disclosure [Abstract] | |||
Contractual coupon interest expense | $ 3,300 | $ 3,300 | |
Amortization of debt issuance costs | 662 | 599 | $ 101 |
Accretion of debt discount | 5,250 | 4,818 | $ 43 |
Total | $ 9,212 | $ 8,717 | |
Effective interest rate | 8.66% | 8.66% |
Mundipharma Agreement - Additio
Mundipharma Agreement - Additional Information (Detail) - USD ($) $ in Thousands | May. 29, 2013 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Company determined development payment | $ 203,288 | $ 218,399 | $ 194,639 | |
Maximum [Member] | Regulatory [Member] | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Potential milestone payments | 16,000 | |||
Maximum [Member] | Commercial progress and sales-dependent [Member] | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Potential milestone payments | $ 107,000 | |||
Mundipharma [Member] | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Company determined development payment | $ 7,000 |
Mundipharma Agreement - Schedul
Mundipharma Agreement - Schedule of Drug Development Liability Adjustments (Detail) $ in Thousands | 12 Months Ended |
Dec. 31, 2015USD ($) | |
Accrued Drug Development Expenses [Roll Forward] | |
Balance at December 31, 2014 | $ 1,141 |
Balance at December 31, 2015 | 259 |
FOLOTYN [Member] | |
Accrued Drug Development Expenses [Roll Forward] | |
Balance at December 31, 2014 | 15,785 |
Transfer from long term to current in 2015 | 0 |
(Less): Expenses incurred in 2015 | (1,099) |
Balance at December 31, 2015 | 14,686 |
FOLOTYN [Member] | Drug Development Liability Current [Member] | |
Accrued Drug Development Expenses [Roll Forward] | |
Balance at December 31, 2014 | 1,141 |
Transfer from long term to current in 2015 | 217 |
(Less): Expenses incurred in 2015 | (1,099) |
Balance at December 31, 2015 | 259 |
FOLOTYN [Member] | Drug Development Liability Long Term [Member] | |
Accrued Drug Development Expenses [Roll Forward] | |
Balance at December 31, 2014 | 14,644 |
Transfer from long term to current in 2015 | (217) |
(Less): Expenses incurred in 2015 | 0 |
Balance at December 31, 2015 | $ 14,427 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) $ in Thousands, € in Millions | Mar. 10, 2016USD ($) | Oct. 27, 2015USD ($) | Dec. 17, 2014USD ($) | Jun. 27, 2014 | Jun. 19, 2014ANDAdefendant | Dec. 09, 2013defendant | Jul. 17, 2013USD ($) | Jan. 31, 2016USD ($) | Feb. 28, 2015USD ($) | Feb. 28, 2014USD ($) | Apr. 30, 2012EUR (€) | Feb. 28, 2010 | Nov. 30, 2009USD ($) | Oct. 31, 2008USD ($)shares | Mar. 31, 2014USD ($) | Dec. 31, 2015USD ($)Country | Dec. 31, 2014USD ($) | Dec. 31, 2013USD ($) | Dec. 31, 2010USD ($) | Nov. 30, 2014USD ($) | Jul. 31, 2013USD ($) | Jan. 31, 2012USD ($) | May. 31, 2006USD ($) |
Long-term Purchase Commitment [Line Items] | |||||||||||||||||||||||
Rental expense | $ 1,700 | $ 1,900 | $ 1,200 | ||||||||||||||||||||
Potential milestone achievement | $ 100 | 100 | |||||||||||||||||||||
Amount receivable on approval of oral form of FUSILEV | $ 200 | ||||||||||||||||||||||
Percentage of royalty on annual worldwide sales under condition one | 20.00% | ||||||||||||||||||||||
Additional license fees | $ 66,000 | ||||||||||||||||||||||
Acquisition-related contingent obligations | $ 1,439 | 2,441 | |||||||||||||||||||||
Percentage of royalties on net sale of licensed products | 20.00% | ||||||||||||||||||||||
Consideration paid under agreement (shares) | $ 1,000 | ||||||||||||||||||||||
Deferrals and contributions | $ 6,500 | 4,700 | |||||||||||||||||||||
Settlement | $ 7,000 | ||||||||||||||||||||||
Legal fees | $ 100 | ||||||||||||||||||||||
Ligand Contingent Consideration | 5,227 | 4,901 | |||||||||||||||||||||
Subsequent Event [Member] | |||||||||||||||||||||||
Long-term Purchase Commitment [Line Items] | |||||||||||||||||||||||
Payment period | 30 days | ||||||||||||||||||||||
Allergan [Member] | |||||||||||||||||||||||
Long-term Purchase Commitment [Line Items] | |||||||||||||||||||||||
Up-front non-refundable payment | $ 41,500 | ||||||||||||||||||||||
License costs | $ 300 | ||||||||||||||||||||||
Nippon Kayaku [Member] | |||||||||||||||||||||||
Long-term Purchase Commitment [Line Items] | |||||||||||||||||||||||
Upfront fee | $ 15,000 | ||||||||||||||||||||||
Payment related to agreement | 10,000 | ||||||||||||||||||||||
Payment on achievement of commercialization milestones | 126,000 | ||||||||||||||||||||||
TopoTarget [Member] | |||||||||||||||||||||||
Long-term Purchase Commitment [Line Items] | |||||||||||||||||||||||
Potential milestone achievement | 278,000 | ||||||||||||||||||||||
Upfront fee | $ 30,000 | ||||||||||||||||||||||
Percentage of development cost | 70.00% | ||||||||||||||||||||||
Percentage of development cost that is funded by TopoTarget for joint development plan | 30.00% | ||||||||||||||||||||||
Additional payments based on the achievement of certain development | $ 10,000 | ||||||||||||||||||||||
Aggregate payout value | $ 17,800 | ||||||||||||||||||||||
Second milestone payment | $ 25,000 | ||||||||||||||||||||||
Common Class A [Member] | Allergan [Member] | |||||||||||||||||||||||
Long-term Purchase Commitment [Line Items] | |||||||||||||||||||||||
Stock issued (shares) | shares | 25,000 | ||||||||||||||||||||||
FUSILEV ANDA [Member] | |||||||||||||||||||||||
Long-term Purchase Commitment [Line Items] | |||||||||||||||||||||||
Number of additional plaintiffs | defendant | 3 | ||||||||||||||||||||||
FOLOTYN ANDA [Member] | |||||||||||||||||||||||
Long-term Purchase Commitment [Line Items] | |||||||||||||||||||||||
Number of defendants | defendant | 5 | ||||||||||||||||||||||
Number of abbreviated new drug applications | ANDA | 4 | ||||||||||||||||||||||
Maximum [Member] | |||||||||||||||||||||||
Long-term Purchase Commitment [Line Items] | |||||||||||||||||||||||
Acquisition-related contingent obligations | 5,200 | 4,900 | |||||||||||||||||||||
Milestone Payments [Member] | |||||||||||||||||||||||
Long-term Purchase Commitment [Line Items] | |||||||||||||||||||||||
Milestone payments | $ 5,000 | 66,000 | |||||||||||||||||||||
Milestone payments related to sales | 30,000 | ||||||||||||||||||||||
Ligand Contingent Consideration | $ 6,000 | ||||||||||||||||||||||
Milestone Payments [Member] | Subsequent Event [Member] | |||||||||||||||||||||||
Long-term Purchase Commitment [Line Items] | |||||||||||||||||||||||
Ligand Contingent Consideration | $ 6,000 | ||||||||||||||||||||||
FOLOTYN [Member] | |||||||||||||||||||||||
Long-term Purchase Commitment [Line Items] | |||||||||||||||||||||||
Percentage of royalty on annual worldwide sales under condition one | 8.00% | ||||||||||||||||||||||
Percentage of royalty on annual worldwide sales under condition two | 9.00% | ||||||||||||||||||||||
Percentage of royalty on annual worldwide sales under condition three | 11.00% | ||||||||||||||||||||||
FOLOTYN [Member] | Minimum [Member] | |||||||||||||||||||||||
Long-term Purchase Commitment [Line Items] | |||||||||||||||||||||||
Amount of annual worldwide sales on which royalty is payable under condition two | $ 150,000 | ||||||||||||||||||||||
Amount of annual worldwide sales on which royalty is payable under condition three | 300,000 | ||||||||||||||||||||||
FOLOTYN [Member] | Maximum [Member] | |||||||||||||||||||||||
Long-term Purchase Commitment [Line Items] | |||||||||||||||||||||||
Amount of annual worldwide sales on which royalty is payable under condition one | 150,000 | ||||||||||||||||||||||
Amount of annual worldwide sales on which royalty is payable under condition two | 300,000 | ||||||||||||||||||||||
ZEVALIN [Member] | |||||||||||||||||||||||
Long-term Purchase Commitment [Line Items] | |||||||||||||||||||||||
Milestone payments | $ 5,000 | ||||||||||||||||||||||
ZEVALIN [Member] | Licensing Agreements [Member] | |||||||||||||||||||||||
Long-term Purchase Commitment [Line Items] | |||||||||||||||||||||||
Minimum number of countries outside U.S. approved ZEVALIN for treatment | Country | 40 | ||||||||||||||||||||||
Fees paid to Bayer for acquiring licensing rights | € | € 19 | ||||||||||||||||||||||
Term | 15 years | ||||||||||||||||||||||
Up-front non-refundable payment | $ 500 | ||||||||||||||||||||||
License fee and service revenue | $ 3,000 | ||||||||||||||||||||||
Percentage of royalty on net sales | 20.00% | ||||||||||||||||||||||
Talon Therapeutics, Inc. [Member] | |||||||||||||||||||||||
Long-term Purchase Commitment [Line Items] | |||||||||||||||||||||||
Acquisition-related contingent obligations | $ 1,400 | $ 2,400 | |||||||||||||||||||||
Contingent value rights future cash payments | $ 195,000 | $ 195,000 | |||||||||||||||||||||
SPI-2012 [Member] | |||||||||||||||||||||||
Long-term Purchase Commitment [Line Items] | |||||||||||||||||||||||
Potential milestone achievement | $ 238,000 | ||||||||||||||||||||||
SPI-2012 [Member] | Subsequent Event [Member] | |||||||||||||||||||||||
Long-term Purchase Commitment [Line Items] | |||||||||||||||||||||||
Milestone payments | $ 3,000 | ||||||||||||||||||||||
Poziotinib [Member] | Licensing Agreements [Member] | |||||||||||||||||||||||
Long-term Purchase Commitment [Line Items] | |||||||||||||||||||||||
Milestone payments related to sales | $ 358,000 | ||||||||||||||||||||||
Nevada [Member] | Principal executive office [Member] | |||||||||||||||||||||||
Long-term Purchase Commitment [Line Items] | |||||||||||||||||||||||
Facility lease, non-cancelable operating lease expiring date | Apr. 30, 2019 | ||||||||||||||||||||||
California [Member] | Research and development facility [Member] | |||||||||||||||||||||||
Long-term Purchase Commitment [Line Items] | |||||||||||||||||||||||
Facility lease, non-cancelable operating lease expiring date | May 31, 2019 | ||||||||||||||||||||||
INDIA | ZEVALIN [Member] | Licensing Agreements [Member] | |||||||||||||||||||||||
Long-term Purchase Commitment [Line Items] | |||||||||||||||||||||||
Term | 15 years | ||||||||||||||||||||||
Recognition period | 10 years |
Commitments and Contingencies95
Commitments and Contingencies - Schedule of Future Minimum Lease Payments (Detail) $ in Thousands | Dec. 31, 2015USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2,016 | $ 1,283 |
2,016 | 1,172 |
2,017 | 1,209 |
2,018 | 460 |
2,019 | 0 |
Operating lease future minimum payments, Total | $ 4,124 |
Income Taxes - Components of (L
Income Taxes - Components of (Loss) Income before (Provision) Benefit for Income Taxes (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Income Tax Disclosure [Abstract] | |||
United States | $ (56,554) | $ (37,327) | $ (30,437) |
Foreign | 6,175 | (6,205) | (6,199) |
Loss before income taxes | $ (50,379) | $ (43,533) | $ (36,636) |
Income Taxes - Provision (Benef
Income Taxes - Provision (Benefit) for Income Taxes (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Current: | |||
Federal | $ 113 | $ 1,529 | $ (8,357) |
State | 5 | 126 | (691) |
Foreign | 148 | 29 | 0 |
Current, total | 266 | 1,684 | (9,048) |
Deferred: | |||
Federal | 114 | 495 | 36,183 |
State | 26 | 7 | (1,637) |
Foreign | 0 | 0 | 0 |
Deferred, total | 140 | 502 | 34,546 |
Total income tax provision | $ 406 | $ 2,186 | $ 25,498 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Income Taxes [Line Items] | |||
Change in tax credit carryforwards | $ 113 | $ 1,529 | $ (8,357) |
Tax benefit | (406) | (2,186) | (25,498) |
Valuation allowance | 71,815 | 45,983 | |
Increase (decrease) in valuation allowance due to deferred tax assets | (25,800) | 3,600 | |
Research and development tax credits | 22,082 | 9,045 | |
Unrecognized tax benefits, if recognized, would affect the effective tax rate | 700 | 700 | $ 300 |
Talon [Member] | |||
Income Taxes [Line Items] | |||
Increase (decrease) in valuation allowance due to deferred tax assets | $ 17,200 | ||
Research Tax Credit Carryforward [Member] | |||
Income Taxes [Line Items] | |||
Tax benefit | 400 | ||
Federal [Member] | |||
Income Taxes [Line Items] | |||
Net operating loss carryforwards | $ 111,500 | ||
Net operating loss carryforwards expiration year | 2,018 | ||
Research and development tax credits | $ 22,900 | ||
Research and development tax credits beginning expiration year | 2,027 | ||
State [Member] | |||
Income Taxes [Line Items] | |||
Net operating loss carryforwards | $ 92,700 | ||
Research and development tax credits | 3,000 | ||
Foreign [Member] | |||
Income Taxes [Line Items] | |||
Net operating loss carryforwards | $ 8,900 | ||
Net operating loss carryforwards expiration year | 2,022 |
Income Taxes - Income Tax Provi
Income Taxes - Income Tax Provision (Benefit) Differs from Computed Using Federal Statutory Rate Applied to Income before Taxes (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Income Tax Disclosure [Abstract] | |||
Tax provision computed at the federal statutory rate | $ (17,619) | $ (15,236) | $ (12,822) |
State tax, net of federal benefit | 232 | 66 | (246) |
Research credits | (2,974) | (2,134) | (2,254) |
FIN 48 uncertain tax positions | 0 | 0 | 0 |
Change in tax credit carryforwards | (4,965) | 0 | 0 |
Transaction costs | 0 | (11) | 880 |
Officers compensation | 1,577 | 1,895 | 2,178 |
Stock based compensation | 535 | 299 | 501 |
Permanent items and other | (487) | 21,742 | (1,080) |
Domestic manufacturing deduction | 0 | (630) | 767 |
Tax differential on foreign earnings | 1,435 | 1,570 | 1,123 |
Change in tax rate | (903) | (519) | (283) |
Valuation allowance | 23,575 | (4,856) | 36,734 |
Total income tax provision | $ 406 | $ 2,186 | $ 25,498 |
Income Taxes - Components of Co
Income Taxes - Components of Company's Deferred Tax Assets (Detail) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Deferred tax assets: | ||
Net operating loss carry forwards | $ 41,251 | $ 40,505 |
Research credits | 22,082 | 9,045 |
Stock based compensation | 4,828 | 3,703 |
Deferred revenue | 2,280 | 1,893 |
Development costs | 5,504 | 5,950 |
Returns and allowances | 1,363 | 4,161 |
Other, net | 9,887 | 9,082 |
Total deferred tax assets before valuation allowance | 87,195 | 74,339 |
Valuation allowance | (71,815) | (45,983) |
Total deferred tax assets | 15,380 | 28,356 |
Deferred tax liabilities: | ||
Basis difference in debt | (713) | (907) |
Depreciation and amortization differences | (21,446) | (34,088) |
Net deferred tax liability | $ (6,779) | $ (6,639) |
Income Taxes - Summary of Unrec
Income Taxes - Summary of Unrecognized Tax Benefits (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Reconciliation of Unrecognized Tax Benefits, Excluding Amounts Pertaining to Examined Tax Returns [Roll Forward] | |||
Balance at beginning of year | $ 1,944 | $ 2,212 | $ 5,482 |
Adjustments related to prior year tax positions | 1,318 | (915) | (200) |
Increases related to current year tax positions | 1,236 | 647 | 648 |
Decreases due to settlements | 0 | 0 | (1,227) |
Decreases related to prior year tax positions | 0 | 0 | (2,491) |
Balance at end of year | $ 4,498 | $ 1,944 | $ 2,212 |
Selected Quarterly Financial102
Selected Quarterly Financial Data (Unaudited) (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Quarterly Financial Information Disclosure [Abstract] | |||||||||||
Total revenues | $ 50,329 | $ 28,627 | $ 44,982 | $ 38,618 | $ 51,861 | $ 47,990 | $ 46,855 | $ 40,124 | $ 162,556 | $ 186,830 | $ 155,854 |
Operating loss | (2,963) | (16,074) | (34) | (21,661) | (1,632) | (4,127) | (1,396) | (24,414) | (40,732) | (31,569) | (38,785) |
Net loss | $ (4,153) | $ (18,724) | $ (2,346) | $ (25,562) | $ (2,976) | $ (11,539) | $ (3,563) | $ (27,641) | $ (50,785) | $ (45,719) | $ (62,134) |
Basic ($ per share) | $ (0.07) | $ (0.28) | $ (0.04) | $ (0.39) | $ (0.05) | $ (0.18) | $ (0.06) | $ (0.44) | $ (0.78) | $ (0.71) | $ (1.02) |
Net (loss) income per share-diluted ($ per share) | $ (0.07) | $ (0.28) | $ (0.04) | $ (0.39) | $ (0.05) | $ (0.18) | $ (0.06) | $ (0.44) | $ (0.78) | $ (0.71) | $ (1.02) |
Subsequent Event (Details)
Subsequent Event (Details) - Subsequent Event [Member] - USD ($) $ in Millions | Mar. 10, 2016 | Jan. 08, 2016 |
Subsequent Event [Line Items] | ||
Payment period | 30 days | |
ZEVALIN, FOLOTYN, BELEODAQ, And MARQIBO [Member] | ||
Subsequent Event [Line Items] | ||
Total consideration received | $ 6 |
Schedule II - Valuation and 104
Schedule II - Valuation and Qualifying Accounts (Detail) - Allowance for Doubtful Accounts [Member] - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Movement in Valuation Allowances and Reserves [Roll Forward] | |||
Balance at Beginning of Period | $ 120 | $ 206 | $ 228 |
Additions (Recovery) to Bad Debt Expense | 0 | (85) | 11 |
Charged to Other Accounts | 0 | 0 | 0 |
Deductions (1) | 0 | (1) | (33) |
Balance at End of Period | $ 120 | $ 120 | $ 206 |