Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2018 | Apr. 30, 2018 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2018 | |
Document Fiscal Year Focus | 2,018 | |
Document Fiscal Period Focus | Q1 | |
Trading Symbol | SPPI | |
Entity Registrant Name | SPECTRUM PHARMACEUTICALS INC | |
Entity Central Index Key | 831,547 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 104,055,102 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 |
Current assets: | ||
Cash and cash equivalents | $ 183,513 | $ 227,323 |
Marketable securities | 48,403 | 248 |
Accounts receivable, net of allowance for doubtful accounts of $71 and $71, respectively | 33,375 | 32,260 |
Other receivables | 2,906 | 2,133 |
Inventories | 5,028 | 5,715 |
Prepaid expenses and other assets | 3,803 | 10,067 |
Total current assets | 277,028 | 277,746 |
Property and equipment, net of accumulated depreciation | 593 | 589 |
Intangible assets, net of accumulated amortization | 130,319 | 137,159 |
Goodwill | 18,227 | 18,162 |
Other assets | 18,106 | 53,783 |
Total assets | 444,273 | 487,439 |
Current liabilities: | ||
Accounts payable and other accrued liabilities | 50,927 | 58,117 |
Accrued payroll and benefits | 3,401 | 9,261 |
Deferred revenue | 0 | 3,872 |
FOLOTYN development liability | 275 | 275 |
Convertible senior notes | 38,819 | 38,224 |
Total current liabilities | 93,422 | 109,749 |
FOLOTYN development liability, less current portion | 12,008 | 12,111 |
Deferred revenue, less current portion | 0 | 315 |
Acquisition-related contingent obligations | 6,563 | 6,272 |
Deferred tax liabilities | 1,447 | 1,438 |
Other long-term liabilities | 6,539 | 6,215 |
Total liabilities | 119,979 | 136,100 |
Commitments and contingencies | ||
Stockholders’ equity: | ||
Preferred stock | 0 | 0 |
Common stock, $0.001 par value; 175,000,000 shares authorized; 103,935,398 and 100,742,735 shares issued and outstanding at March 31, 2018 and December 31, 2017, respectively | 103 | 100 |
Additional paid-in capital | 820,701 | 837,347 |
Accumulated other comprehensive (loss) income | (819) | 15,999 |
Accumulated deficit | (495,691) | (502,107) |
Total stockholders’ equity | 324,294 | 351,339 |
Total liabilities and stockholders’ equity | 444,273 | 487,439 |
Series B junior participating preferred stock [Member] | ||
Stockholders’ equity: | ||
Preferred stock | 0 | 0 |
Series E Convertible Voting Preferred Stock [Member] | ||
Stockholders’ equity: | ||
Preferred stock | $ 0 | $ 0 |
Condensed Consolidated Balance3
Condensed Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 |
Allowance for doubtful accounts receivable | $ 71 | $ 71 |
Preferred stock, par value ($ per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (shares) | 5,000,000 | 5,000,000 |
Preferred stock, shares issued (shares) | 0 | 0 |
Preferred stock, shares outstanding (shares) | 0 | 0 |
Common stock, par value ($ per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (shares) | 175,000,000 | 175,000,000 |
Common stock, shares issued (shares) | 103,935,398 | 100,742,735 |
Common stock, shares outstanding (shares) | 103,935,398 | 100,742,735 |
Series B junior participating preferred stock [Member] | ||
Preferred stock, par value ($ per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (shares) | 1,500,000 | 1,500,000 |
Preferred stock, shares issued (shares) | 0 | 0 |
Preferred stock, shares outstanding (shares) | 0 | 0 |
Series E Convertible Voting Preferred Stock [Member] | ||
Preferred stock, par value ($ per share) | $ 0.001 | $ 0.001 |
Preferred stock, stated value ($ per share) | $ 10,000 | $ 10,000 |
Preferred stock, shares authorized (shares) | 2,000 | 2,000 |
Preferred stock, shares issued (shares) | 0 | 0 |
Preferred stock, shares outstanding (shares) | 0 | 0 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Revenues: | ||
Product sales, net | $ 28,111 | $ 25,845 |
License fees and service revenue | 2,384 | 3,256 |
Total revenues | 30,495 | 29,101 |
Operating costs and expenses: | ||
Cost of sales (excludes amortization of intangible assets) | 6,813 | 8,135 |
Cost of service revenue | 0 | 2,103 |
Selling, general and administrative | 24,104 | 19,104 |
Research and development | 17,895 | 14,779 |
Amortization of intangible assets | 6,947 | 6,889 |
Total operating costs and expenses | 55,759 | 51,010 |
Loss from operations | (25,264) | (21,909) |
Other income (expense): | ||
Interest expense, net | (230) | (2,052) |
Change in fair value of contingent consideration related to acquisitions | (291) | (197) |
Other income, net | 9,972 | 410 |
Total other income (expense) | 9,451 | (1,839) |
Loss before income taxes | (15,813) | (23,748) |
(Provision) benefit for income taxes | (3) | 201 |
Net loss | $ (15,816) | $ (23,547) |
Net loss per share: | ||
Basic and diluted ($ per share) | $ (0.16) | $ (0.30) |
Weighted average shares outstanding: | ||
Basic and diluted (shares) | 100,809,853 | 78,523,023 |
Condensed Consolidated Stateme5
Condensed Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Statement of Comprehensive Income [Abstract] | ||
Net loss | $ (15,816) | $ (23,547) |
Other comprehensive (loss) income: | ||
Unrealized gain on available-for-sale securities, net of income tax of $960 for the three months ended March 31, 2017 | 0 | 1,807 |
Cumulative effect of ASU 2016-01 adoption on January 1, 2018 for unrealized gains on equity securities, net of income tax; recorded as a reclassification to accumulated deficit (see Note 3(a)) | (17,211) | 0 |
Foreign currency translation adjustments | 393 | 152 |
Other comprehensive (loss) income | (16,818) | 1,959 |
Total comprehensive loss | $ (32,634) | $ (21,588) |
Condensed Consolidated Stateme6
Condensed Consolidated Statements of Comprehensive Loss (Parenthetical) $ in Thousands | 3 Months Ended |
Mar. 31, 2017USD ($) | |
Statement of Comprehensive Income [Abstract] | |
Tax on available-for-sale securities | $ 960 |
Condensed Consolidated Stateme7
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Cash Flows From Operating Activities: | ||
Net loss | $ (15,816) | $ (23,547) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 6,995 | 6,982 |
Stock-based compensation | 4,478 | 3,720 |
Accretion of debt discount on 2018 Convertible Notes, recorded to interest expense (Note 13) | 533 | 1,381 |
Amortization of deferred financing costs on 2018 Convertible Notes, recorded to interest expense (Note 13) | 61 | 166 |
Unrealized gains from transactions denominated in foreign currency | (8) | (11) |
Change in cash surrender value of corporate-owned life insurance policy | 0 | (104) |
Deferred tax liabilities | 9 | 74 |
Income tax recognition on unrealized gain for available-for-sale securities | 0 | (960) |
Unrealized gains on marketable securities (Note 3(a)) | (10,196) | 0 |
Change in fair value of contingent consideration related to the Talon and EVOMELA acquisitions (Note 9) | 291 | 197 |
Changes in operating assets and liabilities: | ||
Accounts receivable, net | (583) | 310 |
Other receivables | (762) | (190) |
Inventories | 657 | (1,204) |
Prepaid expenses | 2,134 | 204 |
Other assets | (1,693) | 1,316 |
Accounts payable and other accrued obligations | (7,207) | (4,269) |
Accrued payroll and benefits | (5,860) | (3,807) |
FOLOTYN development liability | (103) | (359) |
Deferred revenue | 0 | (296) |
Other long-term liabilities | 325 | 270 |
Net cash used in operating activities | (26,745) | (20,127) |
Cash Flows From Investing Activities: | ||
Proceeds from redemption of corporate-owned life insurance policy | 4,130 | 0 |
Redemption of mutual funds | (1) | (1) |
Purchases of property and equipment | (52) | (136) |
Net cash provided by (used in) investing activities | 4,077 | (137) |
Cash Flows From Financing Activities: | ||
Proceeds from employees for exercises of stock options | 1,920 | 85 |
Proceeds from employees, for our remittance to tax authorities, related to employee vesting of restricted stock and stock option exercises | 4,645 | 0 |
Payments to tax authorities related to employee surrender of vested restricted stock and stock option exercises | (27,686) | (873) |
Net cash used in financing activities | (21,121) | (788) |
Effect of exchange rates on cash and equivalents | (21) | 26 |
Net decrease in cash and cash equivalents | (43,810) | (21,026) |
Cash and cash equivalents—beginning of period | 227,323 | 158,222 |
Cash and cash equivalents—end of period | 183,513 | 137,196 |
Supplemental disclosure of cash flow information: | ||
Cash paid for income taxes | 0 | 0 |
Cash paid for interest | $ 0 | $ 0 |
Description of Business, Basis
Description of Business, Basis of Presentation, and Operating Segment | 3 Months Ended |
Mar. 31, 2018 | |
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 biopharma company, with a primary strategy comprised of acquiring, developing, and commercializing a broad and diverse pipeline of late-stage clinical and commercial products. We have an in-house clinical development organization with regulatory and data management capabilities, and a commercial infrastructure and a field sales force for our marketed products. Currently, we have six approved oncology/hematology products (FUSILEV, FOLOTYN, ZEVALIN, MARQIBO, BELEODAQ, and EVOMELA) that target different types of cancer including: non-Hodgkin’s lymphoma (“NHL”), advanced metastatic colorectal cancer, acute lymphoblastic leukemia, and multiple myeloma (“MM”). We also have three drugs in mid-to-late stage development (in Phase 2 or Phase 3 clinical trials): • Poziotinib, a novel pan-HER inhibitor used in the treatment of patients with a variety of solid tumors, including breast and lung cancer. • ROLONTIS (formerly referred to as SPI-2012 or LAPS-G-CSF) for chemotherapy-induced neutropenia; and • QAPZOLA (formerly referred to as APAZIQUONE) for immediate intravesical instillation in post-transurethral resection of bladder tumors in patients with non-muscle invasive bladder cancer (“NMIBC”). (b) Basis of Presentation Interim Financial Statements The interim financial data for the three months ended March 31, 2018 and 2017 , respectively, is unaudited, and is not necessarily indicative of our operating results for a full year. In the opinion of our management, the interim data includes normal and recurring adjustments necessary for a fair presentation of our financial results for the three months ended March 31, 2018 and 2017 . Certain information and footnote disclosures normally included in annual financial statements prepared in accordance with United States generally accepted accounting principles (“GAAP”) have been condensed or omitted pursuant to the United States Securities and Exchange Commission (“SEC”) rules and regulations relating to interim financial statements. The December 31, 2017 balances reported herein are derived from the audited Consolidated Financial Statements included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2017 . The accompanying Condensed Consolidated Financial Statements should be read in conjunction with our audited Consolidated Financial Statements and Notes thereto included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2017 , filed with the SEC on March 7, 2018 . Principles of Consolidation The accompanying Condensed Consolidated Financial Statements have been prepared in accordance with GAAP and with the rules and regulations of the 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 Spectrum Pharma Canada (“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 SPC, a legal entity organized in Quebec, Canada in January 2008. Some of our clinical studies are conducted through this “variable interest entity” (as defined under applicable GAAP). We fund all of SPC’s operating costs, and since we assume all risks and rewards for this entity, we meet the criteria as being its “primary beneficiary.” Accordingly, SPC’s balance sheets and statements of operations are included in our Condensed 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 three months ended March 31, 2018 and 2017 , 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 United States. |
Summary of Significant Accounti
Summary of Significant Accounting Policies and Use of Estimates | 3 Months Ended |
Mar. 31, 2018 | |
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 our inventories can be recovered; (v) the recoverability of our reported goodwill and intangible assets; (vi) the realization of our tax assets and estimates of our tax liabilities; (vii) the likelihood of payment and value of contingent liabilities; (viii) the fair value of our investments; (ix) the valuation of our stock options and the periodic expense recognition of stock-based compensation; and (x) the potential outcome of our ongoing or threatened litigation. Our accounting policies and estimates that most significantly impact the presented amounts within our Condensed Consolidated Financial Statements are further described below: (i) Revenue Recognition Impact of the New Revenue Recognition Standard : ASU No. 2014-09 , Revenue from Contracts with Customers (“Topic 606”), became effective for us on January 1, 2018. Our disclosure within the below sections to this footnote reflects our updated accounting policies that are affected by this new standard. We applied the “modified retrospective” transition method for open contracts for the implementation of Topic 606; this resulted in the recognition of an aggregate $4.7 million , net of tax, decrease to our January 1, 2018 “accumulated deficit” on our accompanying Condensed Consolidated Balance Sheets for the cumulative impact of applying this new standard. We made no adjustments to our previously-reported total revenues, as those periods continue to be presented in accordance with our historical accounting practices under Topic 605, Revenue Recognition . See Notes 4, 5, and 19 for additional quantitative and qualitative revenue disclosures in accordance with Topic 606. Required Elements of Our Revenue Recognition : Revenue from our (a) product sales, (b) out-license arrangements, and (c) service arrangements is recognized under Topic 606 in a manner that reasonably reflects the delivery of our goods and/or services to customers in return for expected consideration and includes the following elements: (1) we ensure that we have an executed contract(s) with our customer that we believe is legally enforceable; (2) we identify the “performance obligations” in the the respective contract; (3) we determine the “transaction price” for each performance obligation in the the respective contract; (4) we allocate the transaction price to each performance obligation; and (5) we recognize revenue only when we satisfy each performance obligation. These five elements, as applied to each of our three revenue categories, are summarized below: (a) Product Sales : We sell our products to pharmaceutical 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 our product sales is recognized as physical delivery of product occurs (when our customer obtains control of the product), in return for agreed-upon consideration. Our gross product sales (i.e., delivered units multiplied by the contractual price per unit) are reduced by our corresponding gross-to-net (“GTN”) estimates using the “expected value” method, resulting in our reported “product sales, net” in the accompanying Condensed Consolidated Statements of Operations, reflecting the amount we ultimately expect to realize in net cash proceeds, taking into account our current period gross sales and related cash receipts, and the subsequent cash disbursements on these sales that we estimate for the various GTN categories discussed below. These estimates are based upon information received from external sources (such as written or oral information obtained from our customers with respect to their period-end inventory levels and sales to end-users during the period), in combination with management’s informed judgments. Due to the inherent uncertainty of these estimates, the actual amount incurred (of some, or all) of product returns, government chargebacks, prompt pay discounts, commercial rebates, Medicaid rebates, and distribution, data, and GPO administrative fees may be materially above or below the amount estimated, then requiring prospective adjustments to our reported net product sales. These GTN estimate categories are each discussed below: Product Returns Allowances : Our FUSILEV, MARQIBO, and BELEODAQ customers are contractually permitted to return purchased products beginning at its expiration date and within six months thereafter. Our EVOMELA customers are permitted to return purchased product beginning at six months prior to its expiration date, and within 12 months thereafter (as well as for overstock inventory, as determined by end-users). ZEVALIN and FOLOTYN returns for expiry are not contractually permitted. Returns outside of this aforementioned criteria are not customarily allowed. We estimate expected product returns for our allowance based on our historical return rates. Returned product is typically destroyed, since substantially all returns are due to expiry and cannot be resold. 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 : Our out-license arrangements allow licensees to market our product(s) in certain territories for a specific term (representing the out-license of “functional intellectual property”). These arrangements may include one or more of the following forms of consideration: (a) upfront license fees, (b) sales royalties, (c) sales milestone-achievement fees, and (d) regulatory milestone-achievement fees. We recognize revenue for each based on the contractual terms that establish our right to collect payment once the performance obligation is achieved, as follows: (a) Upfront license fees : We determine whether upfront license fees are earned at the time of contract execution (i.e., when rights transfer to the customer) or over the actual (or implied) contractual period of the out-license. As part of this determination, we evaluate whether we have any other requirements to provide substantive services that are inseparable from the performance obligation of the license transfer. Our customers’ “distinct” rights to licensed “functional intellectual property” at the time of contract execution results in concurrent revenue recognition of all upfront license fees (assuming that there are no other performance obligations at contract execution that are inseparable from this license transfer). (b) Royalties : Under the “sales-or-usage-based royalty exception” we recognize revenue in the same period that our licensees complete product sales in their territory for which we are contractually entitled to a percentage-based royalty receipt. (c) Sales milestones : Under the “sales-or-usage-based royalty exception” we recognize revenue in full within the period that our licensees achieve annual or aggregate product sales levels in their territories for which we are contractually entitled to a specified lump-sum receipt. (d) Regulatory milestones : Under the terms of the respective out-license, regulatory achievements may either be our responsibility, or that of our licensee. • When our licensee is responsible for the achievement of the regulatory milestone, we recognize revenue in full (for the contractual amount due from our licensee) in the period that the approval occurs (i.e., when the “performance obligation” is satisfied by our customer) under the “most likely amount” method. This revenue recognition remains “constrained” until regulatory approval occurs, given its inherent uncertainty and the requirement of a significant revenue reversal not being probable if achievement does not occur. At each reporting period, we re-evaluate the probability of milestone achievement and the associated revenue constraint; any resulting adjustments would be recorded on a cumulative catch-up basis, thus reflected in our financial statements in the period of adjustment. • When we are responsible for the achievement of a regulatory milestone, the “relative selling price method” is applied for purposes of allocating the transaction price to our performance obligations. In such case, we consider (i) the extent of our effort to achieve the milestone and/or the enhancement of the value of the delivered item(s) as a result of milestone achievement and (ii) if the milestone payment is reasonable relative to all of the deliverables and payment terms (including other potential milestone consideration) within the arrangement. We have historically assessed the contractual value of these milestones upon their achievement to be identical to the allocation of value of our performance obligations and thus representing the “transaction price” for each milestone at contract inception. We recognize this revenue in the period that the regulatory approval occurs (i.e., when we complete the “performance obligation”) under the “most likely amount” method, and revenue recognition is otherwise “constrained” until regulatory approval occurs, given its inherent uncertainty and the requirement of a significant revenue reversal not being probable if achievement does not occur. At each reporting period, we re-evaluate the probability of milestone achievement and the associated revenue constraint; any resulting adjustments would be recorded on a cumulative catch-up basis, thus reflected in our financial statements in the period of adjustment. (c) Service Revenue : We receive fees under certain arrangements for (a) sales and marketing services, (b) supply chain services (c) research and development services, and (d) clinical trial management services. Our rights to receive payment for these services may be established by (i) a fixed-fee schedule that covers the term of the arrangement, so long as we meet ongoing performance obligations, (ii) our completion of product delivery in our capacity as a procurement agent, (iii) the successful completion of a phase of drug development, (iv) favorable results from a clinical trial, and/or (v) regulatory approval events. We consider whether revenue associated with these service arrangements is reportable each period, based on our completed services or deliverables (i.e., satisfied “performance obligations”) during the reporting period, and the terms of the arrangement that contractually result in fixed payments due to us. The promised service(s) within these arrangements are distinct and explicitly stated within each contract, and our customer benefits from the separable service(s) delivery/completion. Further, the nature of the promise to our customer as stated within the respective contract is to deliver each named service individually (not a transfer of combined items to which the promised goods or services are inputs), and thus are separable for revenue recognition. (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 equity securities (beginning January 1, 2018 - see Note 3(a) ), mutual funds, and bank certificates of deposit (“Bank CDs”). Beginning January 1, 2018, our realized and unrealized gains (losses) on marketable securities are included in “ Other income, net ” on the accompanying Condensed Consolidated Statements of Operations. Prior to January 1, 2018, our unrealized gains (losses) were included in “other comprehensive (loss) income” on our accompanying Condensed Consolidated Statements of Comprehensive Loss. (iv) Accounts Receivable Our accounts receivables are derived from our product sales and license fees (our service revenue is recorded in “other receivables”), and do not bear interest. The allowance for doubtful accounts is management’s best estimate of the amount of probable credit losses in our existing accounts receivable. Account balances are charged off against the allowance after appropriate collection efforts are exhausted. (v) Inventories We value our inventory at the lower of (i) the actual cost of its purchase or manufacture, or (ii) its net realizable value. Inventory cost is determined on the first-in, first-out method. 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 of each product lot. Manufacturing costs of drug products that are pending U.S. Food and Drug Administration (“FDA”) approval are expensed through “research and development,” on the accompanying Condensed Consolidated Statements of Operations (rather than being capitalized to “inventories”). (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 our 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 1 st ), 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 prior to vesting, though is ultimately adjusted for actual forfeitures. 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, though recognized expense is ultimately adjusted for actual forfeitures. 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 our stock options, (c) our stock price volatility over its expected term (and that of our designated peer group with respect to certain market-based awards), and (d) the risk-free interest rate over the expected term. 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. Department of the Treasury yields in effect at award grant, for a period equaling the expected term of the stock option. (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) income” in the Condensed 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) income” in the Condensed Consolidated Balance Sheets. All unrealized foreign exchange gains and losses associated with our intercompany loans are included in “accumulated other comprehensive (loss) income” in the Condensed Consolidated Balance Sheets, as these loans with our foreign subsidiaries are not expected to be settled in the “foreseeable future.” (x) Basic and Diluted Net Loss per Share We calculate basic and diluted net loss 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 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) benefit for income taxes” within the Condensed Consolidated Statements of Operations for the period in which we received the notice. (xii) Research and Development Costs Our research and development costs are expensed as incurred, or as certain milestone payments become due, which are 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. |
Balance Sheet Account Detail
Balance Sheet Account Detail | 3 Months Ended |
Mar. 31, 2018 | |
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 Condensed Consolidated Balance Sheets are summarized below: (a) Cash and Cash Equivalents and Marketable Securities As of March 31, 2018 and December 31, 2017 , our “cash and cash equivalents” were held with major financial institutions. Our “marketable securities” solely relate to our equity holdings in CASI - see Note 10. 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 in our portfolio by investing in highly liquid, highly-rated instruments, and limit investing in long-term maturity instruments. Our investment policy requires that purchased investments in marketable securities may only be in highly-rated instruments, which are primarily United States treasury bills or United States treasury-backed securities, and also limits our investments in securities of any single issuer (excluding any debt or equity securities received from our strategic partners in connection with a license arrangement, as discussed in Note 10 ). The carrying amount of our equity securities, money market funds, and Bank CDs 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 Foreign Currency Translation Gross Gross Estimated Cash and Cash Marketable Securities March 31, 2018 Equity securities* (see Note 3(g) and Note 10 ) $ 8,710 $ (174 ) $ 39,618 $ — $ 48,154 $ — $ 48,154 Bank deposits 20,546 — — — 20,546 20,546 — Money market funds 162,967 — — — 162,967 162,967 — Bank certificates of deposits 249 — — — 249 — 249 Total cash and cash equivalents and marketable securities $ 192,472 $ (174 ) $ 39,618 $ — $ 231,916 $ 183,513 $ 48,403 December 31, 2017 Bank deposits $ 10,965 $ — $ — $ — $ 10,965 $ 10,965 $ — Money market funds 216,358 — — — 216,358 216,358 — Bank certificates of deposits 248 — — — 248 — 248 Total cash and cash equivalents and marketable securities $ 227,571 $ — $ — $ — $ 227,571 $ 227,323 $ 248 * Beginning January 1, 2018, under the new requirements of ASU 2016-01, Recognition and Measurement of Financial Assets and Liabilities , the unrealized gains on our equity securities in CASI Pharmaceuticals, Inc. (NASDAQ: CASI) (“CASI”) are recognized as an increase to “other income, net” on the Consolidated Statements of Operations (rather than through “other comprehensive (loss) income” on the Consolidated Statements of Comprehensive Loss). Our adoption of ASU 2016-01 on January 1, 2018, resulted in a $17.2 million cumulative-effect adjustment, net of income tax, recorded as a decrease to “accumulated other comprehensive (loss) income” and a decrease to “accumulated deficit” on the accompanying Condensed Consolidated Balance Sheets. Our recognized unrealized gain on these equity securities was $10.2 million for the three months ended March 31, 2018 , as reported in “other income, net” on the accompanying Condensed Consolidated Statements of Operations. As of March 31, 2018 , none of our securities had been in a continuous unrealized loss position longer than one year. (b) Property and Equipment, net of Accumulated Depreciation “Property and equipment, net of accumulated depreciation” consists of the following: March 31, 2018 December 31, 2017 Computer hardware and software $ 3,067 $ 2,994 Laboratory equipment 630 630 Office furniture 218 218 Leasehold improvements 2,938 2,938 Property and equipment, at cost 6,853 6,780 (Less): Accumulated depreciation (6,260 ) (6,191 ) Property and equipment, net of accumulated depreciation $ 593 $ 589 Depreciation expense (included within “total operating costs and expenses” in the accompanying Condensed Consolidated Statements of Operations) for the three months ended March 31, 2018 and 2017 , was $49 thousand and $0.1 million , respectively. In February 2016, the FASB issued ASU 2016-02 , which amends the FASB Accounting Standards Codification and creates Topic 842 , Leases . The new topic supersedes Topic 840 , Leases , and requires lease assets and lease liabilities (including those for operating leases) to be presented on the balance sheet at their “gross amounts” and requires additional disclosures regarding lease arrangements. Topic 842 is effective for us beginning January 1, 2019, and mandates a “modified retrospective” transition method. We are currently assessing the impact this guidance will have on our consolidated financial statements. We presently do not have any capital lease arrangements, or have any active contracts that would contain an “embedded lease”. Our current lease arrangements impacted for this gross-up” presentation on our balance sheets, beginning January 1, 2019, are limited to our principal executive office in Henderson, Nevada, and our administrative and research and development facility in Irvine, California, in addition to several other administrative office leases. (c) Inventories “Inventories” consists of the following: March 31, 2018 December 31, 2017 Raw materials $ 1,251 $ 1,077 Work-in-process 2,576 2,551 Finished goods 4,332 5,187 (Less:) Non-current portion of inventories included within "other assets" * (3,131 ) (3,100 ) Inventories $ 5,028 $ 5,715 * The “non-current” portion of inventories is presented within “other assets” in the accompanying Condensed Consolidated Balance Sheets at March 31, 2018 and December 31, 2017 , respectively. This value of $3.1 million at March 31, 2018 represents product that we expect to sell beyond March 31, 2019 and the value at December 31, 2017 represents product that we expect to sell beyond December 31, 2018 . . (d) Prepaid Expenses and Other Assets “Prepaid expenses and other assets” consists of the following: March 31, 2018 December 31, 2017 Other miscellaneous prepaid operating expenses $ 3,148 $ 3,389 Prepaid insurance 603 645 Research and development supplies 52 1,883 Key employee life insurance - cash surrender value — 4,150 Prepaid expenses and other assets $ 3,803 $ 10,067 (e) Other Receivables “Other receivables” consists of the following: March 31, 2018 December 31, 2017 Other miscellaneous receivables* $ 992 $ 1,152 Income tax receivable 637 665 Insurance receivable 1,095 53 Reimbursements due from development partners for incurred research and development expenses 182 263 Other receivables $ 2,906 $ 2,133 * As of March 31, 2018 and December 31, 2017 , the balance is inclusive of $0.4 million and $0.4 million , respectively, of Medicaid rebate credits to be applied against future invoices for each respective state program, and $0.2 million and $0.4 million , respectively, of royalty receivables from Mundipharma International Corporation Limited (“Mundipharma”) for sales of ZEVALIN in Japan. (f) Intangible Assets and Goodwill Intangible assets, net of accumulated amortization and impairment charges consists of the following: March 31, 2018 Historical Accumulated Foreign Impairment Net Amount Full Remaining MARQIBO IPR&D (NHL and other novel indications) $ 17,600 $ — $ — $ — $ 17,600 n/a n/a EVOMELA distribution rights (1) 7,700 (1,185 ) — — 6,515 156 132 BELEODAQ distribution rights 25,000 (7,031 ) — — 17,969 160 115 MARQIBO distribution rights 26,900 (18,262 ) — — 8,638 81 24 FOLOTYN distribution rights (2) 118,400 (57,380 ) — — 61,020 152 56 ZEVALIN distribution rights – U.S. 41,900 (38,426 ) — — 3,474 123 12 ZEVALIN distribution rights – ex-U.S. 23,490 (18,157 ) (1,871 ) — 3,462 96 24 FUSILEV distribution rights (3) 16,778 (9,618 ) — (7,160 ) — 56 0 FOLOTYN out-license (4) 27,900 (15,236 ) — (1,023 ) 11,641 110 52 Total intangible assets $ 305,668 $ (165,295 ) $ (1,871 ) $ (8,183 ) $ 130,319 (1) The FDA approval of EVOMELA in March 2016 triggered a $6 million payment due to CyDex Pharmaceuticals, Inc. (a wholly-owned subsidiary of Ligand Pharmaceuticals Incorporated (“Ligand”) (“Cydex”)). This event also resulted in a reclassification of our $7.7 million “EVOMELA IPR&D” to “EVOMELA distribution rights” due to our ability to begin commercialization of EVOMELA upon FDA approval. Amortization commenced on April 1, 2016, in accordance with our capitalization policy for intangible assets. (2) Beginning June 2016, we adjusted the amortization period of our FOLOTYN distribution rights to November 2022 from March 2025, representing the period through which we expect to have patent protection from generic competition (see Note 16(g) ). (3) On February 20, 2015, the United States 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 in 2015 for the then remaining net book value of FUSILEV distribution rights. (4) On May 29, 2013, we amended our FOLOTYN collaboration agreement with Mundipharma. As a result of the amendment, Europe and Turkey were excluded from Mundipharma’s commercialization territory, and their royalty rates and milestone payments to us were modified. This constituted a change under which we originally valued the FOLOTYN out-license as part of business combination accounting, resulting in an impairment charge (non-cash) of $1.0 million in the second quarter of 2013. December 31, 2017 Historical Accumulated Foreign Impairment Net Amount MARQIBO IPR&D (NHL and other novel indications) $ 17,600 $ — $ — $ — $ 17,600 EVOMELA distribution rights 7,700 (1,037 ) — — 6,663 BELEODAQ distribution rights 25,000 (6,563 ) — — 18,437 MARQIBO distribution rights 26,900 (17,182 ) — — 9,718 FOLOTYN distribution rights 118,400 (54,111 ) — — 64,289 ZEVALIN distribution rights – U.S. 41,900 (37,557 ) — — 4,343 ZEVALIN distribution rights – Ex-U.S. 23,490 (17,232 ) (2,471 ) — 3,787 FUSILEV distribution rights 16,778 (9,618 ) — (7,160 ) — FOLOTYN out-license 27,900 (14,555 ) — (1,023 ) 12,322 Total intangible assets $ 305,668 $ (157,855 ) $ (2,471 ) $ (8,183 ) $ 137,159 Intangible asset amortization expense recognized during the three months ended March 31, 2018 and 2017 , was $6.9 million and $6.9 million , respectively. Estimated intangible asset amortization expense for the remainder of 2018 and the five succeeding fiscal years and thereafter is as follows: Years Ending December 31, Remainder of 2018 $ 20,843 2019 25,185 2020 19,779 2021 18,266 2022 15,882 2023 2,467 2024 and thereafter 10,297 $ 112,719 “Goodwill” consists of the following: March 31, 2018 December 31, 2017 Acquisition of Talon (MARQIBO rights) $ 10,526 $ 10,526 Acquisition of ZEVALIN Ex-U.S. distribution rights 2,525 2,525 Acquisition of Allos (FOLOTYN rights) 5,346 5,346 Foreign currency exchange translation effects (170 ) (235 ) Goodwill $ 18,227 $ 18,162 (g) Other Assets “Other assets” consists of the following: March 31, 2018 December 31, 2017 Equity securities (see Note 10 )* $ — $ 37,530 Key employee life insurance – cash surrender value 11,463 10,737 Inventories - non-current portion 3,131 3,100 Promissory note receivable - long term (see Note 10 ) 1,519 1,517 Income tax receivable** 668 668 Research & development supplies and other 1,325 231 Other assets $ 18,106 $ 53,783 * As of March 31, 2018, we reclassified our presentation of these equity securities from this account caption to “marketable securities” on the face of our accompanying Condensed Consolidated Balance Sheets - see Note 3(a) . ** This value represents the non-current portion of the refundable alternative minimum tax credit that is expected to be received over the next few years (see Note 16 ). (h) Accounts Payable and Other Accrued Liabilities “Accounts payable and other accrued liabilities” consists of the following : March 31, 2018 December 31, 2017 Trade accounts payable and other accrued liabilities $ 29,549 $ 33,648 Accrued rebates 7,713 7,990 Accrued product royalty 3,868 4,339 Allowance for returns 4,549 4,045 Accrued data and distribution fees 2,530 4,305 Accrued GPO administrative fees 312 296 Accrued inventory management fee 560 1,126 Allowance for chargebacks 1,846 2,368 Accounts payable and other accrued liabilities $ 50,927 $ 58,117 Amounts presented within “accounts payable and other accrued liabilities” in the accompanying Condensed Consolidated Balance Sheets for our categories of GTN estimates (see Note 2(i) ) were as follows: Commercial/Medicaid Rebates and Government Chargebacks Distribution, Data, and Product Return Allowances Balance as of December 31, 2016 $ 9,817 $ 5,146 $ 2,309 Add: provisions 106,647 20,104 2,807 (Less): credits or actual allowances (106,106 ) (19,523 ) (1,071 ) Balance as of December 31, 2017 10,358 5,727 4,045 Add: provisions 13,805 3,425 468 (Less): credits or actual allowances (14,604 ) (5,750 ) 36 Balance as of March 31, 2018 $ 9,559 $ 3,402 $ 4,549 (i) Deferred Revenue Deferred revenue (current and non-current) consists of the following: March 31, 2018 December 31, 2017 EVOMELA deferred revenue $ — $ 3,819 ZEVALIN out-license in India territory (see Note 15(b)(iii) ) — 368 Deferred revenue* $ — $ 4,187 * On January 1, 2018, we reclassified the deferred revenue related to our EVOMELA product sales and our ZEVALIN out-license in the India territory of $3.8 million and $0.4 million , respectively. These amounts were included in the $4.7 million aggregate decrease to “accumulated deficit” on January 1, 2018, in accordance with the adoption of Topic 606 (see Note 2(i) ). (j) Other Long-Term Liabilities “Other long-term liabilities” consists of the following: March 31, 2018 December 31, 2017 Accrued executive deferred compensation $ 5,981 $ 5,928 Deferred rent (non-current portion) 20 52 Clinical study holdback fees, non-current 62 59 Other tax liabilities 176 176 Royalty liability 300 — Other long-term liabilities $ 6,539 $ 6,215 |
Gross-to-Net Product Sales
Gross-to-Net Product Sales | 3 Months Ended |
Mar. 31, 2018 | |
Revenue, Net [Abstract] | |
Gross-to-Net Product Sales | GROSS-TO-NET PRODUCT SALES The below table presents a GTN (see Note 2(i) ) product sales reconciliation for the accompanying Condensed Consolidated Statements of Operations: Three Months Ended 2018 2017 Gross product sales $ 49,590 $ 58,217 Commercial rebates and government chargebacks (17,029 ) (27,324 ) Data and distribution fees, GPO fees, and inventory management fees (3,511 ) (4,462 ) Prompt pay discounts (390 ) (270 ) Product returns allowance (549 ) (316 ) Product sales, net $ 28,111 $ 25,845 |
Composition of Total Revenue
Composition of Total Revenue | 3 Months Ended |
Mar. 31, 2018 | |
Segment Reporting [Abstract] | |
Composition of Total Revenue | COMPOSITION OF TOTAL REVENUE The below table presents our net product sales by geography for the three months ended March 31, 2018 and 2017 : Three Months Ended 2018 2017 United States $ 23,198 82.5 % $ 23,801 92.1 % International: Europe 3,489 12.4 % 2,044 7.9 % Asia Pacific 1,424 5.1 % — — % Total international 4,913 17.5 % 2,044 7.9 % Product sales, net $ 28,111 100.0 % $ 25,845 100.0 % The below table presents our net sales by product for the three months ended March 31, 2018 and 2017 : Three Months Ended 2018 2017 FOLOTYN $ 12,721 45.3 % $ 9,274 35.9 % EVOMELA 8,134 28.9 % 6,301 24.4 % BELEODAQ 2,713 9.7 % 2,871 11.1 % ZEVALIN 3,025 10.8 % 2,845 11.0 % MARQIBO 894 3.2 % 1,980 7.7 % FUSILEV 624 2.2 % 2,574 10.0 % Product sales, net $ 28,111 100.0 % $ 25,845 100.0 % The below table presents our license fees and service revenue by source for the three months ended March 31, 2018 and 2017 : Three Months Ended 2018 2017 Out-license of FOLOTYN in all countries except the United States, Canada, Europe, and Turkey: royalties ( Note 14 ) $ 377 15.8 % $ 263 8.1 % Out-license of ZEVALIN: recognition of milestone achievement, upfront cash receipt and subsequent royalties for Asia and certain other territories, excluding China ( Note 11 ) 2,001 83.9 % 615 18.9 % Out-license of ZEVALIN: amortization of upfront cash receipt related to India territory ( Note 15(b)(iii) ) and other — — % 12 0.4 % Out-license of ZEVALIN, FOLOTYN, BELEODAQ, MARQIBO: upfront cash receipt and subsequent royalties for the Canada territory ( Note 15(b)(xiv) ) 6 0.3 % — — % Sales and marketing contracted services ( Note 12 ) — — % 2,366 72.7 % License fees and service revenues $ 2,384 100.0 % $ 3,256 100.0 % |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock-Based Compensation | STOCK-BASED COMPENSATION We report our stock-based compensation expense (inclusive of our incentive stock plan, employee stock purchase plan, and 401(k) contribution matching program) in the accompanying Condensed 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 the three months ended March 31, 2018 and 2017 , was as follows (see Note 18 for a discussion of certain immaterial corrections affecting the presented 2017 amounts below): Three Months Ended 2018 2017 Cost of sales $ 66 $ 30 Selling, general and administrative 3,691 3,238 Research and development 721 452 Total stock-based compensation $ 4,478 $ 3,720 |
Net Loss Per Share
Net Loss Per Share | 3 Months Ended |
Mar. 31, 2018 | |
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 three months ended March 31, 2018 and 2017 : Three Months Ended 2018 2017 Net loss $ (15,816 ) $ (23,547 ) Weighted average shares – basic and diluted 100,809,853 78,523,023 Net loss per share – basic and diluted $ (0.16 ) $ (0.30 ) The below outstanding securities were excluded from the above calculation of net loss per share because their impact under the “treasury stock method” and “if-converted method” would have been anti-dilutive due to our net loss per share in the three months ended March 31, 2018 and 2017 , as summarized below: Three Months Ended 2018 2017 2018 Convertible Notes 3,854,959 10,454,799 Common stock options 5,589,852 1,557,920 Restricted stock awards 1,875,569 1,769,530 Restricted stock units 210,214 217,206 Common stock warrants 261,622 — Employee stock purchase plan shares 24,064 53,927 Total 11,816,280 14,053,382 |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2018 | |
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 Condensed Consolidated Balance Sheets, and their designations among three fair value measurement categories (see Note 2(xiii)) : March 31, 2018 Level 1 Level 2 Level 3 Total Assets: Bank certificates of deposits $ — $ 249 $ — $ 249 Money market funds — 162,967 — 162,967 Equity securities ( Note 3(a) ) 48,154 — — 48,154 Mutual funds — 59 — 59 Deferred compensation investments (life insurance cash surrender value - Note 3(g) ) — 11,463 — 11,463 * $ 48,154 $ 174,738 $ — $ 222,892 Liabilities: Deferred executive compensation liability ( Note 15(f) ) $ — $ 10,168 $ — $ 10,168 * Drug development liability ( Note 14 ) — — 12,283 12,283 Talon CVR ( Note 9(a) ) — — 6,501 6,501 Corixa Liability ( Note 15(b)(i) ) — — 62 62 $ — $ 10,168 $ 18,846 $ 29,014 December 31, 2017 Level 1 Level 2 Level 3 Total Assets: Bank certificates of deposits $ — $ 248 $ — $ 248 Money market funds — 216,358 — 216,358 Equity securities ( Note 10 ) 37,530 — — 37,530 Mutual funds — 59 — 59 Deferred compensation investments (life insurance cash surrender value) — 14,887 — 14,887 * $ 37,530 $ 231,552 $ — $ 269,082 Liabilities: Deferred executive compensation liability ( Note 15(f) ) $ — $ 11,038 $ — $ 11,038 * Drug development liability ( Note 14 ) — — 12,386 12,386 Talon CVR ( Note 9(a) ) — — 6,210 6,210 Corixa Liability ( Note 15(b)(i) ) — — 62 62 $ — $ 11,038 $ 18,658 $ 29,696 * The reported value of “deferred compensation investments” is based on the cash surrender value of the life insurance policies, while the value of the “deferred executive compensation liability” is based on the market value of the underlying investment holdings. We did not have any transfers between “Level 1” and “Level 2” (see Note 2(xiii) ) for all periods presented. The table below summarizes the 2017 and 2018 activity of our liabilities that are valued with unobservable inputs: Fair Value Measurements of Balance as of December 31, 2016 $ 14,445 FOLOTYN development liability (see Note 14 ) (744 ) Talon CVR fair value adjustment - MARQIBO (see Note 9(a) ) 4,957 Balance as of December 31, 2017 18,658 FOLOTYN development liability (see Note 14 ) (103 ) Talon CVR fair value adjustment - MARQIBO (see Note 9(a) ) 291 Balance as of March 31, 2018 $ 18,846 * This amount is comprised of the current and non-current portions of “FOLOTYN development liability” and the non-current portion of “acquisition-related contingent obligations” on our accompanying Condensed Consolidated Balance Sheets. Our carrying amounts of financial instruments such as cash equivalents, accounts receivable, prepaid expenses, accounts payable, and accrued liabilities, excluding acquisition-related contingent obligations, approximate their related fair values due to their short-term nature. |
Business Combinations and Conti
Business Combinations and Contingent Consideration | 3 Months Ended |
Mar. 31, 2018 | |
Business Combinations [Abstract] | |
Business Combinations and Contingent Consideration | BUSINESS COMBINATIONS AND CONTINGENT CONSIDERATION (a) Acquisition of Talon Therapeutics, Inc. Overview of Talon Acquisition 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 consisted 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 a contingent value right (“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 million if all sales and regulatory approval milestones are achieved, as summarized below: • $5 million upon the achievement of net sales of MARQIBO in excess of $30 million in any calendar year • $10 million upon the achievement of net sales of MARQIBO in excess of $60 million in any calendar year • $25 million upon the achievement of net sales of MARQIBO in excess of $100 million in any calendar year • $50 million upon the achievement of net sales of MARQIBO in excess of $200 million in any calendar year • $100 million upon the achievement of net sales of MARQIBO in excess of $400 million in any calendar year; and • $5 million upon receipt of marketing authorization from the FDA regarding Menadione Topical Lotion Talon CVR Fair Value as of March 31, 2018 and December 31, 2017 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 Condensed Consolidated Statements of Operations. Fair Value December 31, 2017 $ 6,210 Fair value adjustment for the three months ended March 31, 2018 291 March 31, 2018 $ 6,501 (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 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 a wholly-owned subsidiary of Ligand for an initial license fee of $3 million , and assumed responsibility for EVOMELA’s then-ongoing clinical and regulatory development program. We accounted for this transaction as a business combination, which required 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 $60 million upon the achievement of annual net sales thresholds (exclusive of the $6 million milestone payment triggered in March 2016, as discussed below), however, we do not expect to achieve these sales thresholds based on our estimated market size for this product and our projected market share at the time of the acquisition and to date. We also must pay Ligand royalties of 20% on our net sales of EVOMELA in all territories. Our EVOMELA royalty obligation and sales-based milestones are jointly treated as part of an “executory contract” (as defined under GAAP) that is connected with an at-market supply agreement for Captisol that was executed concurrently with this acquisition (requiring the continuing involvement of CyDex). As a result, our royalty obligation and sales-based milestone arrangements are treated as separate transactions, distinct from the consideration for the EVOMELA rights. Our royalty expenses are reported through “cost of sales” in our Condensed Consolidated Statements of Operations in the same period of our recognized revenue for the product sale. 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 transaction date. The allocation of the total purchase price to the net assets acquired is as follows: EVOMELA IPR&D 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 net cash flows to a single present value (discounted) amount. We applied our net cash flow projections for EVOMELA over 10 years and a discount rate of 25% , taking into account our estimates of future incremental earnings that may be achieved upon regulatory approval and commercialization of the product(s). The fair value of the Ligand Contingent Consideration (as defined below) liability was determined using the probability of success and the discounted cash flow method of the income approach (representing unobservable “ Level 3” inputs (see Note 2(xiii) ) for regulatory and sales-based milestones due to Ligand upon achievement). In March 2016, the FDA approved EVOMELA, triggering a $6 million milestone payment to Ligand (“Ligand Contingent Consideration”) that was paid in April 2016. “EVOMELA IPR&D” of $7.7 million was reclassified in April 2016 to “EVOMELA distribution rights” that is reported within “Intangible assets, net of accumulated amortization” in the accompanying Condensed Consolidated Balance Sheets as of March 31, 2018 (see Note 3(f) ). Amortization related to this intangible asset commenced on April 1, 2016. (c) Allos Acquisition We acquired Allos Therapeutics, Inc. (“Allos”) in September 2012 for cash consideration of $205.2 million and assumed its FOLOTYN distribution rights (see Note 14 ). We accounted for this transaction as a business combination, which required that assets acquired and liabilities assumed be recognized on the balance sheet at their fair values as of the transaction date. We have no ongoing contingent consideration obligations from this transaction. |
Out-License of Marqibo, Zevalin
Out-License of Marqibo, Zevalin, & Evolema in China Territory | 3 Months Ended |
Mar. 31, 2018 | |
Other Commitments [Abstract] | |
Out-License of Marqibo, Zevalin, & Evolema 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, 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 three of our commercialized oncology drugs, ZEVALIN, MARQIBO, and EVOMELA (“CASI Out-Licensed Products”), in greater China (which includes Taiwan, Hong Kong and Macau). CASI is 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. Our consideration consisted of CASI common stock for their distribution rights of ZEVALIN and EVOMELA, and a secured promissory note for their distribution rights of MARQIBO. CASI Ownership at March 31, 2018 Under certain conditions that expired in December 2017, we had a right to purchase additional shares of CASI common stock in order to maintain our post-investment ownership percentage if CASI issued additional securities. During 2017 and 2016, we acquired an additional 1.5 million and 4.6 million common shares of CASI, respectively, at par value. Our aggregate holding of 11.5 million CASI common shares as of March 31, 2018 represented an approximate 14.5% ownership, with a fair market value of $48.2 million (see Note 3(a)). Proceeds Received from CASI The proceeds we received in 2014, 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, 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. (b) Value estimated using the terms of the $1.5 million promissory note, the application of a synthetic debt rating based on CASI’s publicly-available financial information, and the prevailing interest yields on similar public debt securities as of September 17, 2014. This full balance was reclassified beginning December 31, 2017 to “other assets” (presented within non-current assets on the accompanying Condensed Consolidated Balance Sheets) from “other receivables” (presented within current assets) due to an amended maturity date of September 17, 2019. (c) Presented within “license fees and service revenue” in the Consolidated Statements of Operations for the year ended December 31, 2015 (see below). 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. License Fee Revenue Recognized The $9.7 million value of the upfront proceeds (undiscounted, and net of certain foreign exchange adjustments) from CASI were recognized in 2015 within “license fees and service revenue” on 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 its commercial supply. |
Out-License Of Zevalin In Certa
Out-License Of Zevalin In Certain Ex-U.S. Territories | 3 Months Ended |
Mar. 31, 2018 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [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, 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 three of our commercialized oncology drugs, ZEVALIN, MARQIBO, and EVOMELA (“CASI Out-Licensed Products”), in greater China (which includes Taiwan, Hong Kong and Macau). CASI is 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. Our consideration consisted of CASI common stock for their distribution rights of ZEVALIN and EVOMELA, and a secured promissory note for their distribution rights of MARQIBO. CASI Ownership at March 31, 2018 Under certain conditions that expired in December 2017, we had a right to purchase additional shares of CASI common stock in order to maintain our post-investment ownership percentage if CASI issued additional securities. During 2017 and 2016, we acquired an additional 1.5 million and 4.6 million common shares of CASI, respectively, at par value. Our aggregate holding of 11.5 million CASI common shares as of March 31, 2018 represented an approximate 14.5% ownership, with a fair market value of $48.2 million (see Note 3(a)). Proceeds Received from CASI The proceeds we received in 2014, 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, 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. (b) Value estimated using the terms of the $1.5 million promissory note, the application of a synthetic debt rating based on CASI’s publicly-available financial information, and the prevailing interest yields on similar public debt securities as of September 17, 2014. This full balance was reclassified beginning December 31, 2017 to “other assets” (presented within non-current assets on the accompanying Condensed Consolidated Balance Sheets) from “other receivables” (presented within current assets) due to an amended maturity date of September 17, 2019. (c) Presented within “license fees and service revenue” in the Consolidated Statements of Operations for the year ended December 31, 2015 (see below). 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. License Fee Revenue Recognized The $9.7 million value of the upfront proceeds (undiscounted, and net of certain foreign exchange adjustments) from CASI were recognized in 2015 within “license fees and service revenue” on 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 its commercial supply. |
Mundipharma [Member] | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |
Out-License Of Zevalin In Certain Ex-U.S. Territories | OUT-LICENSE OF ZEVALIN IN CERTAIN EX-U.S. TERRITORIES On November 16, 2015, we entered into an out-license agreement with Mundipharma for its 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 these proceeds, $15 million was recognized within “license fees and service revenue” in the fourth quarter of 2015, and the remaining $3 million payment was recognized in full by June 30, 2017. In April 2018, we received $2 million due to Mundipharma’s achievement of a specified sales milestone during the three months ended March 31, 2018 , which was recognized within “license fees and service revenue” on our accompanying Condensed Statements of Operations (see Note 5 ). Mundipharma is required to reimburse us for our payment of royalties due to Bayer Pharma AG (“Bayer”) from its ZEVALIN sales - see Note 15(b)(ii) . |
Co-Promotion Arrangement With E
Co-Promotion Arrangement With Eagle Pharmaceuticals | 3 Months Ended |
Mar. 31, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Co-Promotion Arrangement With Eagle Pharmaceuticals | CO-PROMOTION ARRANGEMENT WITH EAGLE PHARMACEUTICALS 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 products along with our products, in return for fixed monthly payments (aggregating $12.8 million ), as well as variable sales-based milestones, over an 18 month contract term that commenced on January 1, 2016 and ended on June 30, 2017 (the “Eagle Agreement”). On July 1, 2017, our sales force ceased marketing Eagle products and the Eagle Agreement expired under its terms. The fixed receipts from Eagle for our sales activities, as well as reimbursements of third-party marketing services, are recognized within “license fees and service revenue” on our accompanying Condensed Consolidated Statements of Operations, and was $2.4 million for the three months ended March 31, 2017 . No sales-based milestones were achieved in the current or prior periods. An allocation of our sales personnel costs that are dedicated to Eagle sales activities are reported within “cost of service revenue” on our accompanying Condensed Consolidated Statements of Operations, as are reimbursable costs for Eagle marketing activities. These were an aggregate $2.1 million for the three months ended March 31, 2017 . |
Convertible Senior Notes
Convertible Senior Notes | 3 Months Ended |
Mar. 31, 2018 | |
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 (equaling 120,000 notes, denominated in $1,000 principal units) due December 2018 (the “2018 Convertible Notes”). As of March 31, 2018 and December 31, 2017, $40.6 million of principal of the 2018 Convertible Notes was outstanding due to our open market purchases discussed below. The 2018 Convertible Notes are convertible into shares of our common stock at a conversion rate of 95 shares per $1,000 principal units, equating to 3.9 million common shares if fully converted at March 31, 2018. 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 we received net proceeds of $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 “Conversion Hedge”). We recorded the Conversion Hedge on a net cost basis of $13.1 million , as a reduction to “additional paid-in capital” in our accompanying Condensed Consolidated Balance Sheets. Under applicable GAAP, the Conversion Hedge transaction has not been (and is not expected to be) marked-to-market through earnings or comprehensive income. Open Market Purchases of 2018 Convertible Notes and Conversion Hedge Unwind in December 2016 and October 2017 In December 2016, we completed two open market purchases of our 2018 Convertible Notes, aggregating 9,963 note units (equivalent to $10 million principal value) for $9.0 million . We recognized an aggregate loss of $25 thousand on the retirement of these 2018 Convertible Notes (based on its carrying value under GAAP), which is included in “other income (expense), net” on the Consolidated Statements of Operations for the year ended December 31, 2016. Accordingly, as of December 31, 2016, $110 million in principal of our 2018 Convertible Notes remained outstanding. Concurrent with these two open market purchases in December 2016, we unwound a portion of our previously sold warrants and previously purchased call options (which were part of our Conversion Hedge described below) for aggregate net proceeds of $21 thousand . We recorded a corresponding net increase to “additional paid-in capital” in the Consolidated Balance Sheets as of December 31, 2016. In October 2017, we completed an additional open market purchase of our 2018 Convertible Notes, aggregating 69,472 note units (equivalent to $69.5 million principal value) for $27.3 million in cash and 5.4 million newly-issued shares of our common stock, then worth $73 million . We recognized a loss of $0.8 million on the retirement of these 2018 Convertible Notes (based on its carrying value under GAAP), which was included in “other (expense) income, net” on the Consolidated Statements of Operations for the year ended December 31, 2017. Accordingly, as of March 31, 2018 and December 31, 2017, $40.6 million in principal of our 2018 Convertible Notes remained outstanding. Concurrent with this open market purchase in October 2017, we also unwound a portion of the previously sold warrants and previously purchased call options that were part of our Conversion Hedge for aggregate net proceeds of $5.8 million . We recorded a corresponding net increase to “additional paid-in capital” in the Consolidated Balance Sheets as of December 31, 2017. Conversion Hedge We entered into Conversion Hedge transactions in December 2013 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 (at such time, it matched the 11.4 million common shares into which the holders could convert the 2018 Convertible Notes); 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 (reduced by the partial unwinding of these instruments, as discussed above). 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 Notes' 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 March 31, 2018 , the 2018 Convertible Notes are eligible to be converted into our common stock as the above elements (1) through (2) 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 our common stock, or a combination of cash and shares of common stock. However, if the holders of the 2018 Convertible Notes do not elect to convert into shares of our common stock, our December 2018 obligation to repay the principal amount of $40.6 million in cash, plus any accrued and unpaid interest, will remain unchanged. Carrying Value and Fair Value The carrying value of the 2018 Convertible Notes as of March 31, 2018 and December 31, 2017 , is summarized as follows: March 31, 2018 December 31, 2017 Principal amount $ 40,565 $ 40,565 (Less): Unamortized debt discount (amortized through December 2018) (1,568 ) (2,101 ) (Less): Debt issuance costs (178 ) (240 ) Carrying value $ 38,819 $ 38,224 As of March 31, 2018 and December 31, 2017 , the estimated aggregate fair value of the 2018 Notes is $63.8 million and $74.3 million , respectively. 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 Condensed Consolidated Statements of Operations for the 2018 Convertible Notes for the three months ended March 31, 2018 and 2017 : Three Months Ended 2018 2017 Contractual coupon interest expense $ 279 $ 757 Amortization of debt issuance costs 61 166 Accretion of debt discount 533 1,381 Total $ 873 $ 2,304 Effective interest rate 8.41 % 8.65 % |
FOLOTYN License Agreement And D
FOLOTYN License Agreement And Development Liability | 3 Months Ended |
Mar. 31, 2018 | |
Business Combinations [Abstract] | |
FOLOTYN License Agreement And Development Liability | FOLOTYN LICENSE AGREEMENT AND DEVELOPMENT LIABILITY As the result of our acquisition of Allos Therapeutics, Inc. on September 5, 2012 (see Note 10(c) ), we assumed a strategic collaboration agreement with Mundipharma (as amended and/or restated, the “Mundipharma Collaboration Agreement”), as well as certain FOLOTYN clinical development obligations (the “FOLOTYN Development Liability”). Mundipharma Collaboration Agreement Summary Under the Mundipharma Collaboration Agreement, we retained full commercialization rights for FOLOTYN in the United States 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, 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 amendment and restatement of the Mundipharma Collaboration Agreement, we received a one-time $7 million payment from Mundipharma for certain research and development activities to be performed by us. As a result of the amendment and restatement of the 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 million , and commercial progress and sales-dependent milestone payments of up to $107 million (see Note 15(b)(vii) for July 2017 achievement), (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 each bear our own FOLOTYN development costs. Effective as of May 1, 2015, we modified the Mundipharma Collaboration Agreement to revise the conditions for our exercise of the option to gain commercialization rights in Switzerland from Mundipharma, as well as royalties payable to us (in the tiered double-digits) on Mundipharma’s net sales in Switzerland. FOLOTYN Development Liability The fair value of the FOLOTYN Development Liability within the 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 contractually required, (ii) estimates of expected cash outflows to third parties for these clinical 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 adjust this liability during each quarterly period, with corresponding adjustments for incurred costs recorded as credits to “research and development” expense in our accompanying Condensed Consolidated Statements of Operations. FOLOTYN FOLOTYN FOLOTYN Balance as of December 31, 2017 $ 275 $ 12,111 $ 12,386 Transfer from long-term to current in 2018 103 (103 ) — (Less): Expenses incurred in 2018 (103 ) — (103 ) Balance as of March 31, 2018 $ 275 $ 12,008 $ 12,283 |
Financial Commitments & Conting
Financial Commitments & Contingencies And License Agreements | 3 Months Ended |
Mar. 31, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | |
Financial Commitments & Contingencies And License Agreements | FINANCIAL COMMITMENTS & CONTINGENCIES AND LICENSE AGREEMENTS (a) Facility 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 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. (b) In/Out Licensing Agreements and Co-Development Arrangements The in-license agreements for our commercialized and development-stage drug products provide us with territory-specific rights to their manufacture and distribution (including further sub-licensing/out-licensing, rights). We are generally responsible for all related clinical development costs, patent filings and maintenance costs, marketing costs, and liability insurance costs. We are also obligated to make specified milestone payments to our licensors upon the achievement of certain regulatory and sales milestones, and to pay royalties based on our net sales of all in-licensed products. We also enter into out-license agreements for territory-specific rights to our drug products which include one or more of: upfront license fees, royalties from our licensees’ sales, and/or milestone payments from our licensees’ sales or regulatory achievements. For certain development-stage drug products, we may enter into cost-sharing arrangements with our licensees and licensors. Our most significant of these agreements, and the key financial terms and our accounting for each, are summarized below: (i) ZEVALIN U.S.: In-Licensing and Development in the United States In December 2008, we acquired rights to commercialize and develop ZEVALIN in the United States as the result of a transaction with Cell Therapeutics, Inc. through our wholly-owned subsidiary, RIT Oncology LLC. 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 million based on ZEVALIN sales in the United States. 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 Condensed Consolidated Balance Sheets as of March 31, 2018 and December 31, 2017 , 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 a €19 million acquisition of licensing rights to market ZEVALIN outside of the United States from Bayer. ZEVALIN is currently approved in approximately 40 countries outside the United States for the treatment of B-cell NHL, including countries in Europe, Latin America, and Asia. We amended the agreement in February 2016, which adjusted our tiered royalty to Bayer from the single-digits to 20% . The term of the agreement, as amended, continues until the expiration of the last-to-expire ZEVALIN patent in the relevant country, or 15 years from the date of first commercial sale of ZEVALIN in such country, whichever is longer. (iii) ZEVALIN Ex-U.S.: Out-License Agreement with Dr. Reddy’s In June 2014, we executed an exclusive License Agreement with Dr. Reddy’s Laboratories Ltd. (“Dr. Reddy’s”) for ZEVALIN distribution rights within India. The agreement term is 15 years from the receipt of pending approval of ZEVALIN from the Drug Controller General of India. In December 2014, upon our execution of a drug supply agreement, an upfront and non-refundable payment of $0.5 million was triggered and paid to us in February 2015. The recognition of the applicable portion of this upfront receipt is no longer reported on a straight-line basis within “license fees and service revenue” on our accompanying Condensed Consolidated Statements of Operations, due to the adoption of Topic 606 as of January 1, 2018 (see Note 2(i) ). Additionally, sales and regulatory milestones, each aggregating $1.5 million (for a total of $3 million if both achieved) are due to us upon Dr. Reddy’s achievement, as well as a 20% royalty on its net sales of ZEVALIN in India. (iv) ZEVALIN Ex-U.S.: Out-License Agreement with Mundipharma In November 2015, we entered into an out-license agreement with Mundipharma for its commercialization of ZEVALIN in Asia (excluding India and Greater China), Australia, New Zealand, Africa, the Middle East, and Latin America (including the Caribbean islands). In return, we received $18 million (comprised of $15 million received in December 2015 and $3 million received in January 2016). Of these proceeds, $15 million was recognized within “license fees and service revenue” in the fourth quarter of 2015, and the remaining $3 million payment was recognized in full by June 30, 2017. Mundipharma is required to reimburse us for our payment of royalties due to Bayer from its ZEVALIN sales - see Note 15(b)(ii) . In March 2018, Mundipharma achieved a specified sales milestone, resulting in a $2 million receipt due to us (subsequently received in April 2018); this amount was recognized within “license fees and service revenue” on our accompanying Condensed Statements of Operations for the three months ended March 31, 2018 (see Note 5 ). (v) FUSILEV: 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. This provided us with an exclusive license to use regulatory filings related to FUSILEV, and a non-exclusive license under certain patents and know-how to develop, manufacture, and sell FUSILEV in the field of oncology in North America. The contractual royalty percentage on our FUSILEV net sales due to Merck is set at the mid-single digits; however, in September 2017, we paid Merck $2.6 million in full settlement of all royalty obligations under the agreement. We are no longer contractually obligated to pay Merck any royalties on our future net sales of FUSILEV, though we remain obligated to remit a $0.2 million payment upon FDA approval of our oral form of FUSILEV. This regulatory milestone has not been met, and no amounts have been accrued in our accompanying Condensed Consolidated Balance Sheets for its potential achievement. (vi) FOLOTYN: In-License Agreement with Sloan-Kettering Institute, SRI International and Southern Research Institute In December 2002, Allos entered into an in-license agreement for the drug now marketed as FOLOTYN with Sloan-Kettering Institute for Cancer Research, SRI International, and Southern Research Institute. We assumed this agreement when we acquired Allos in September 2012. The agreement provides for our exclusive worldwide rights to a portfolio of patents and patent applications related to FOLOTYN, though we are required to fund certain drug development programs. In addition, we pay graduated royalties to our licensors based on our worldwide annual net sales of FOLOTYN (including our sub- licensees). These 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 . (vii) FOLOTYN: Out-License Agreement with Mundipharma As a result of our acquisition of Allos (see Note 10(c) ), we assumed “the Mundipharma Collaboration Agreement” as well as certain FOLOTYN clinical development obligations. Under the Mundipharma Collaboration Agreement (see Note 15 ), we retained full commercialization rights for FOLOTYN in the United States and Canada, with Mundipharma having exclusive rights to commercialize FOLOTYN in all other countries in the world, except in Europe and Turkey. We are contractually entitled to receive regulatory and sales milestone payments from Mundipharma upon its achievement of such milestones, which aggregate $16 million and $107 million , respectively, as well as tiered double-digit royalties on Mundipharma’s net sales. In July 2017, FOLOTYN was approved in Japan for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma. Consequently, we received $3 million from Mundipharma in August 2017 for this milestone achievement. This amount was recognized within “license fees and service revenue” on our Consolidated Statements of Operations for the year ended December 31, 2017. In August 2017, FOLOTYN was commercially launched in Japan. This triggered a contractual milestone of $2.0 million from Mundipharma. This amount was recorded within “license fees and service revenue” on our Consolidated Statements of Operations for the year ended December 31, 2017. (viii) EVOMELA: In-License Agreement with CyDex Pharmaceuticals, Inc. In March 2013, we completed the acquisition of exclusive global development rights to EVOMELA from CyDex, a wholly-owned subsidiary of Ligand (see Note 9(b) ), and assumed responsibility for its then-ongoing clinical and regulatory development program. We filed a New Drug Application (“NDA”) with the FDA in December 2015 for its use as a conditioning treatment prior to autologous stem cell transplant for patients with MM, and in March 2016, the FDA communicated its approval. Consequently, we made a $6 million contractual milestone payment to Ligand in April 2016. We reclassified $7.7 million from “EVOMELA IPR&D rights” to “EVOMELA distribution rights” which is presented within “intangible assets, net of accumulated amortization and impairment charges” (see Note 3(f) ) within our accompanying Condensed Consolidated Balance Sheets as of March 31, 2018 . We are required to pay Ligand additional amounts of up to $60 million (exclusive of the $6 million milestone paid in April 2016), upon our achievement of specified net sales thresholds. We are also responsible to pay Ligand royalties of 20% on our net sales of EVOMELA in all territories. (ix) MARQIBO: Acquisition of Talon Therapeutics, Inc. and Related Contingent Consideration Agreement In July 2013, we completed the acquisition of Talon, through which we obtained exclusive global development and commercialization rights to MARQIBO (see Note 9(a) ). As part of this acquisition, the former Talon stockholders have contingent financial rights that we have valued and presented on our accompanying Condensed Consolidated Balance Sheets as a $6.5 million and $6.2 million liability within “acquisition-related contingent obligations” as of March 31, 2018 and December 31, 2017 , respectively. The maximum payout value of the contingent financial rights to the former Talon shareholders is $195 million , assuming we achieve all sales and regulatory approval milestones. In addition, we are contractually obligated to pay royalties in the single digits on our net sales of MARQIBO and a portion of sublicensing revenue may be due upon our receipt of such revenue for MARQIBO. (x) QAPZOLA: License Agreements with Allergan, Inc. and NDDO Research Foundation In October 2008, we entered into an exclusive development and commercialization collaboration agreement with Allergan, Inc. (“Allergan”) for QAPZOLA pursuant to which Allergan paid us an up-front non-refundable fee of $41.5 million at execution (which we had recognized in full within “license fees and service revenue” by December 31, 2013). Concurrently we also entered into a letter agreement with NDDO Research Foundation (“NDDO”), pursuant to which we agreed to pay NDDO the following in relation to QAPZOLA milestones: (a) upon FDA acceptance of our NDA, the issuance of 25,000 of our common shares (which occurred in March 2016 and the $0.1 million value of these shares was included in “research and development” expense for the year ended December 31, 2016), and (b) upon FDA approval, a one-time payment of $0.3 million (which has not yet been met, and no amounts have been accrued in our accompanying Consolidated Balance Sheets for its potential achievement). In January 2013, we entered into a second amendment to the license, development, supply and distribution agreement with Allergan. This amendment relieved Allergan of its development and commercialization obligations and resulted in our acquisition of its rights in the United States, Europe, and other territories, in exchange for our agreement to pay a tiered single-digit royalty on our sales of certain products containing QAPZOLA. (xi) QAPZOLA: 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 QAPZOLA in Asia, except North and South Korea (the “Nippon Kayaku Territory”). In addition, Nippon Kayaku received exclusive rights to QAPZOLA for the treatment of NMIBC in the Nippon Kayaku Territory, including Japan and China. Nippon Kayaku will conduct QAPZOLA 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 QAPZOLA in the Nippon Kayaku Territory. Under the terms of this agreement, Nippon Kayaku paid us an upfront fee of $15 million (which we recognized within “license fees and service revenue” in full by December 31, 2013). Under the terms of the agreement, we are entitled to receive $10 million and $126 million from Nippon Kayaku upon the achievement of certain regulatory and commercialization milestones, respectively (some of which are our responsibility to achieve). Nippon Kayaku is also obligated to pay us royalties on its net sales of QAPZOLA in the mid-teen digits. (xii) BELEODAQ: In-License and Collaboration Agreement with Onxeo In February 2010, we entered into an in-license and collaboration agreement with TopoTarget A/S (now Onxeo DK) (“Onxeo”), for the development and commercialization of BELEODAQ, as amended in October 2013. We paid Onxeo an upfront fee of $30 million (and agreed to additional payments described below) for rights in North America and India, with an option for China. We are contractually obligated to pay royalties in the mid-teen digits on our net sales of BELEODAQ. All development and studies of BELEODAQ are conducted under a joint development plan (of which we fund 70% and Onxeo funds 30% ). We have final decision-making authority for all developmental activities in North America and India (and China upon exercise of its option). Onxeo has final decision-making authority for all developmental activities in all other jurisdictions. In February 2014, upon FDA acceptance of our NDA, we were contractually obligated to issue Onxeo one million shares of our common stock and to make a $10 million milestone payment. The aggregate value of this milestone at achievement was $17.8 million , and was recognized within “research and development” expense in 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 peripheral T-cell lymphoma. As a result, we made a second milestone payment to Onxeo of $25 million in November 2014. This amount was capitalized as “BELEODAQ distribution rights” and is presented within “intangible assets, net of accumulated amortization and impairment charges” (see Note 3(f) ). We are also contractually obligated to pay Onxeo upon our achievements of other regulatory events and sales thresholds, up to $88 million and $190 million , respectively. These milestone amounts are not included within “total liabilities” in our accompanying Consolidated Balance Sheets. (xiii) ROLONTIS: Co-Development and Commercialization Agreement with Hanmi Pharmaceutical Co. Ltd In October 2014, we exercised our option under a License Option and Research Collaboration Agreement dated January 2012 (as amended) with Hanmi Pharmaceutical Co. Ltd., or Hanmi, for ROLONTIS (formerly referred to as “LAPS-G-CSF” or “SPI-2012”), a drug based on Hanmi’s proprietary LAPSCOVERY™ technology for the treatment of chemotherapy induced neutropenia. Under the terms of this agreement, as amended, we have primary financial responsibility for the ROLONTIS development plan and hold its worldwide rights (except for Korea, China, and Japan). We are contractually obligated to pay Hanmi royalties in the mid-teen digits on our net sales of ROLONTIS. In January 2016, the first patient was dosed with ROLONTIS in a clinical trial. This triggered our contractual milestone payment to Hanmi, and in April 2016, we (i) issued 318,750 shares of our common stock, then valued at $2.3 million , and (ii) remitted a $0.4 million payment to the Internal Revenue Service (the IRS) on its behalf for related tax obligations. This aggregate $2.7 million value was recognized within “research and development” expense in our Consolidated Statements of Operations for the year ended December 31, 2016. We are responsible for further contractual payments upon our achievement of regulatory and sales milestones, up to $13 million and $225 million , respectively. These amounts are not included within “total liabilities” in our accompanying Condensed Consolidated Balance Sheets. (xiv) Poziotinib: In-License Agreement with Hanmi In February 2015, we executed an in-license agreement with Hanmi for poziotinib, a pan-HER inhibitor in Phase 2 clinical trials, (which has also shown single agent activity in the treatment of various cancer types during Phase I studies, including breast, gastric, colorectal, and lung cancers), and made an upfront payment for these rights. This payment was recognized within “research and development” expense in the Consolidated Statements of Operations for the year ended December 31, 2015. We are also contractually obligated to pay Hanmi royalties in the low to mid-teen digits on our net sales of poziotinib. Under the terms of this agreement, we received the exclusive rights to commercialize poziotinib, excluding Korea and China. Hanmi and its development partners are fully responsible for the completion of on-going Phase 2 trials in Korea. We are financially responsible for all other clinical studies. We are contractually obligated to make payments to Hanmi upon our achievement of certain regulatory and sales milestones, aggregating $33 million and $325 million , respectively, which are not included within “total liabilities” in our accompanying Condensed Consolidated Balance Sheets. We will pay Hanmi royalties in the low to mid-teen digits on our net sales of poziotinib. These amounts are not included within “total liabilities” in our accompanying Condensed Consolidated Balance Sheets. (xv) ZEVALIN, FOLOTYN, BELEODAQ, and MARQIBO: Out-License Agreement with Servier in Canada, Inc. in Canada In January 2016, we entered into a strategic partnership with Servier Canada, Inc. (“Servier”) for the out-licenses of ZEVALIN, FOLOTYN, BELEODAQ, and MARQIBO. We received an aggregate $6 million of upfront proceeds in the first quarter of 2016, which was recognized within “license fees and service revenue” in our Consolidated Statements of Operations for the year ended December 31, 2016. We are also entitled to milestone receipts (aggregating $2.0 million ) upon Servier’s achievement of specific regulatory approvals, and a high single-digit royalty on its sales of these products. (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 previously entered into an employment agreement with our former Chief Executive Officer, Rajesh C. Shrotriya, M.D., 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. Effective December 17, 2017, Dr. Shrotriya’s employment was terminated without cause in accordance with his employment agreement. We accrued for all contractual cash amounts due and unpaid to him within “accrued payroll and benefits” on the accompanying Condensed Consolidated Balance Sheets as of December 31, 2017. We entered into new employment agreements with each of our named executive officers (CEO, COO, and CFO) in April 2018, which supersede such individuals’ prior Change in Control Severance Agreements. These new agreements provide for the payment of certain benefits to each such individual upon his separation of employment from us under specified circumstances. The benefits provided are designed to protect earned benefits in the case that they are terminated without cause or as a result of a change in control of our Company or in the case of death or disability, and to encourage them to act in the best interests of our stockholders at all times during the course of a change in control transaction or other significant events involving us. (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 March 31, 2018 and December 31, 2017 , the aggregate DC Plan deferrals by employees and our discretionary contributions totaled $10.2 million and $11.0 million , respectively, and are included within “accounts payable and other accrued liabilities” and “other long-term liabilities” in the accompanying Condensed 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. Stockholder Litigation Olutayo Ayeni v. Spectrum Pharmaceuticals, Inc., et al. (Filed September 21, 2016 in the United States District Court, Central District of California; Case No. 2:16-cv-07074) (the “Ayeni Action”) and Glen Hartsock v. Spectrum Pharmaceuticals, Inc., et al. (Filed September 28, 2016 in the United States District Court, District Court of Nevada Case; No. 2:16-cv-02279-RFB-GWF) (the “Hartsock Action”). On November 15, 2016, the Ayeni Action was transferred to the United States District Court for the District of Nevada. The parties have stipulated to a consolidation of the Ayeni Action with the Hartsock Action. These class action lawsuits allege that we and certain of our executive officers made false or misleading statements and failed to disclose material facts about our business and the prospects of approval for our NDA to the FDA for QAPZOLA in violation of Section 10(b) (and Rule 10b-5 promulgated thereunder) and 20(a) of the Securities Exchange Act of 1934, as amended. The plaintiffs seek damages, interest, costs, attorneys’ fees, and other unspecified equitable relief. We believe that these claims are without merit, and intend to vigorously defend against these claims. Furthermore, as of March 31, 2018 , the value of a potential settlement cannot be reasonably estimated given its highly uncertain nature. |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | INCOME TAXES We apply an estimated annual effective tax rate (“ETR”) approach for calculating a tax provision for interim periods, as required under GAAP. We recorded a provision for income taxes of $3 thousand for the three months ended March 31, 2018 , and a benefit for income taxes of $0.2 million for the three months ended March 31, 2017 . Our ETR differs from the U.S. federal statutory tax rate of 21% primarily as a result of nondeductible expenses, state income taxes, foreign income taxes, and the impact of a valuation allowance on our deferred tax assets. Our provision for income taxes is computed using the asset and liability method, under which deferred tax assets and liabilities are recognized for the expected future tax consequences of temporary differences between the financial reporting and tax bases of assets and liabilities, and for the expected future tax benefit to be derived from tax loss and credit carryforwards. Deferred tax assets and liabilities are determined using the enacted tax rates in effect for the years in which those tax assets are expected to be realized. A valuation allowance is established when it is more likely than not the future realization of all or some of the deferred tax assets will not be achieved. The evaluation of the need for a valuation allowance is performed on a jurisdiction by jurisdiction basis, and includes a review of all available positive and negative evidence. We recognize the impact of a tax position in our financial statements only if that position is more likely than not to be sustained upon examination by taxing authorities, based on the technical merits of the position. Any interest and penalties related to uncertain tax positions will be reflected in income tax expense. The intraperiod tax allocation rules require that we allocate the provision for income taxes between continuing operations and other categories of earnings. In prior periods where we have a year-to-date pretax loss from continuing operations and year-to-date pre-tax income in other categories of earnings, such as other comprehensive income, ASC 740-20-45-7 requires that we allocate the income tax provision to other categories of earnings, and then record a related tax benefit in continuing operations. For the three months ended March 31, 2017 , we recognized net income from investments and currency transactions within other comprehensive income while sustaining operating losses from continuing operations. As a result of the required allocation under ASC 740-20-45-7, we recorded tax expense of $1.0 million in “other comprehensive income” on the accompanying Condensed Consolidated Statements of Comprehensive Loss for the three months ended March 31, 2017 , and a tax benefit of $0.2 million within “(provision) benefit for income taxes” on the Condensed Consolidated Statements of Operations for the three months ended March 31, 2017 . Beginning January 1, 2018, under the new requirements of ASU 2016-01, Recognition and Measurement of Financial Assets and Liabilities , we do not anticipate intraperiod tax allocations in connection with other comprehensive (loss) income going forward. On December 22, 2017, the U.S. government enacted comprehensive tax legislation commonly referred to as the Tax Cuts and Jobs Act (the “Tax Act”). Changes include, but are not limited to, a corporate tax rate decrease from 35% to 21% effective for tax years beginning in 2018, the transition of U.S. international taxation from a worldwide tax system to a territorial system, which includes a new federal tax on global intangible low-taxed income (Global Minimum Tax or GMT), and a one-time transition tax on the mandatory deemed repatriation of cumulative foreign earnings as of December 31, 2017. We calculated a provisional estimate of the impact of the Tax Act. In addition, the SEC Staff issued SAB 118 , which provides guidance on accounting for the tax effects of the Tax Act. S AB 118 provides a measurement period that should not extend beyond one year from the Tax Act enactment date for companies to complete the accounting under ASC 740 . In accordance with SAB 118 , a company must reflect the income tax effects of those aspects of the Tax Act for which the accounting under ASC 740 is complete. To the extent that a company’s accounting for certain income tax effects of the Tax Act is incomplete but it is able to determine a reasonable estimate, it must record a provisional estimate in the financial statements. If a company cannot determine a provisional estimate to be included in the financial statements, it should continue to apply ASC 740 on the basis of the provisions of the tax laws that were in effect immediately before the enactment of the Tax Act. At December 31, 2017, we were able to make reasonable estimates of certain effects and, therefore, recorded provisional adjustments. The provisional amounts described below are subject to revisions as we complete our analysis of the Tax Act, collect data, and interpret any additional guidance issued by the United States Treasury Department, Internal Revenue Service, or IRS, FASB, and other standard-setting and regulatory bodies. Adjustments to the provisional amounts may materially impact our consolidated income tax provision (benefit) and effective tax rates in the period(s) in which such adjustments are made. Our accounting for the tax effects of the Tax Act will be completed during the one-year measurement period. Reduction of U.S. federal corporate tax rate: For certain of our deferred tax assets and deferred tax liabilities, we have recorded a provisional decrease in net deferred tax assets of $38.9 million , with a corresponding decrease in the valuation allowance of $41.4 million and a benefit to income tax expense of $2.5 million for the year ended December 31, 2017. This provisional estimate may be affected by other analyses related to the Tax Act, including, but not limited to, the state tax effect of adjustments made to federal temporary differences. Deemed repatriation transition tax: Based upon our preliminary analysis, we have concluded that a net accumulated E&P deficit exists as of December 31, 2017 for our foreign subsidiaries. As a result, we did not accrue any provisional transition tax liabilities. We will continue to gather additional and perform additional analyses to more precisely determine past foreign earnings and related taxes and will update our provisional estimate with respect to the transition tax liability when such work is completed within the one-year measurement period. Valuation allowance: The Tax Act limits the amount taxpayers are able to deduct for net operating loss carryforwards generated in taxable years beginning after December 31, 2017 to 80% of the taxpayer’s taxable income. However, net operating loss carryforwards generated in taxable years ending after December 31, 2017 can be carried forward indefinitely. A taxable temporary difference associated with an indefinite-lived asset is generally considered to be a source of taxable income to support realization of a net operating loss with an unlimited carryforward period. Due to the restriction on the ability to use the net operating loss with unlimited carryforward periods arising in taxable years beginning after December 31, 2017, only 80% of the indefinite-lived taxable temporary difference would serve as a source of taxable income. As a result, the valuation allowance decreased by $2.9 million related to the 80% utilization of the indefinite-lived taxable temporary as a source of taxable income. Under GAAP, we are allowed to make an accounting policy choice with respect to the GMT of either (1) treating taxes due on future U.S. inclusions in taxable income related to GMT as a current-period expense when incurred or (2) as a component of deferred income taxes. We will make our accounting policy election for this item when our analysis is complete, during the measurement period. |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 31, 2018 | |
Equity [Abstract] | |
Stockholders' Equity | STOCKHOLDERS’ EQUITY Sale of Common Stock Under ATM Agreements In December 2015, we entered into a collective at-market-issuance sales agreement with FBR Capital Markets & Co., MLV & Co. LLC, and H.C. Wainwright & Co., LLC. (the “December 2015 ATM Agreement”). The December 2015 ATM Agreement allowed us to raise gross proceeds of up to $100 million from the sale of our common stock through these brokers under our shelf registration statement on Form S-3 (declared effective by the SEC on February 3, 2016; File No. 333-208760) (the “Registration Statement”). As of July 31, 2017, we had fully utilized this ATM facility. In August 2017, we entered into a collective at-market-issuance sales agreement with H.C. Wainwright & Co., LLC., FBR Capital Markets & Co., and MLV & Co. LLC (the "August 2017 ATM Agreement"). The August 2017 ATM Agreement allows us to raise gross proceeds of up to $150 million from the sale of our common stock through these brokers under the Registration Statement. As of March 31, 2018 , approximately $43.9 million remained available for sale under this ATM facility. We sold and issued shares of our common stock under both the December 2015 ATM Agreement and August 2017 ATM Agreement, summarized as follows: Description of Financing Transaction No. of Common Shares Issued Proceeds Received (Net of Broker Commissions and Fees ) Common shares issued pursuant to the December 2015 ATM Agreement during the year ended December 31, 2016 10,890,915 $ 73,869 Common shares issued pursuant to the December 2015 ATM Agreement between July 1, 2017 and July 31, 2017 3,243,882 $ 23,745 Common shares issued pursuant to the August 2017 ATM Agreement between August 1, 2017 and December 31, 2017 10,314,250 $ 104,527 There were no sales of our common stock under the August 2017 ATM Agreement during the three months ended March 31, 2018 . |
Immaterial Restatement Of Prior
Immaterial Restatement Of Prior Period Financial Statements For Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2018 | |
Accounting Changes and Error Corrections [Abstract] | |
Immaterial Restatement Of Prior Period Financial Statements For Stock-Based Compensation | IMMATERIAL RESTATEMENT OF PRIOR PERIOD FINANCIAL STATEMENTS FOR STOCK-BASED COMPENSATION Subsequent to the issuance of our unaudited interim financial statements for the quarter and year-to-date periods ended September 30, 2017, our management identified certain immaterial errors within previously reported operating expense captions of “selling, general, and administrative” and “research and development” that solely relate to our stock-based compensation recognition (see Note 6 ). These errors were primarily the result of an improper system setting during our implementation of a then-new stock-based compensation software in 2012. Consequently, incremental expense for the reversal of previously applied forfeiture estimates was not timely recognized upon the full vesting of each award, as required; this error persisted through September 30, 2017. We considered these errors from a qualitative and quantitative perspective, and concluded they were not material to each prior period. We have restated our accompanying Condensed Consolidated Financial Statements to correct for these immaterial errors for the prior-year interim period presented. Restated Condensed Consolidated Statements of Operations for the three months ended March 31, 2017 : Three Months Ended March 31, 2017 As Previously Reported As Restated Operating costs and expenses: Selling, general and administrative $ 18,607 $ 19,104 Research and development 14,696 14,779 Total operating costs and expenses 50,430 51,010 Loss from operations (21,329 ) (21,909 ) Loss before income taxes (23,168 ) (23,748 ) Net loss $ (22,967 ) $ (23,547 ) Net loss per share: Basic $ (0.29 ) $ (0.30 ) Diluted $ (0.29 ) $ (0.30 ) Restated Condensed Consolidated Statements of Comprehensive Loss for the three months ended March 31, 2017 : Three Months Ended March 31, 2017 As Previously Reported As Restated Net loss $ (22,967 ) $ (23,547 ) Total comprehensive loss $ (21,008 ) $ (21,588 ) Other than for the correction to net loss and stock-based compensation, the restatement adjustments had no impact on cash flows from operating, investing, or financing activities for the three months ended March 31, 2017 . Furthermore, such restatement adjustments had no impact to prior period total assets, total liabilities or total stockholders’ equity. |
Implementation of New Revenue R
Implementation of New Revenue Recognition Standard on January 1, 2018 | 3 Months Ended |
Mar. 31, 2018 | |
Revenue from Contract with Customer [Abstract] | |
Implementation of New Revenue Recognition Standard on January 1, 2018 | IMPLEMENTATION OF NEW REVENUE RECOGNITION STANDARD ON JANUARY 1, 2018 As discussed in Note 2(i), Topic 606 became effective for us on January 1, 2018. We applied the “modified retrospective” transition method for open contracts for its implementation; this resulted in the recognition of an aggregate $4.7 million increase to our January 1, 2018 retained earnings for the tax-effected cumulative effect of initially applying this new standard, with no adjustments to our prior period face financial statements. Our prior periods continue to be presented in accordance with our historical accounting practices under Topic 605 . Had we continued to apply Topic 605 for our revenue recognition for the three months ended March 31, 2018 , the “proforma” impact to our Condensed Consolidated Statements of Operations is presented in the table below: Three Months Ended March 31, 2018 As Reported Under Topic 606 Adjustments If Reported Under Topic 605 Revenue: Product sales, net $ 28,111 $ 397 $ 28,508 License fees and service revenue 2,384 120 2,504 Total revenues $ 30,495 $ 517 $ 31,012 Loss from operations (25,264 ) 517 (24,747 ) Loss before income taxes (15,813 ) 517 (15,296 ) Net loss $ (15,816 ) $ 517 $ (15,299 ) Net loss per share: Basic and Diluted $ (0.16 ) $ 0.01 $ (0.15 ) Had we continued to apply Topic 605 for our revenue recognition for the three months ended March 31, 2018 , the “proforma” impact to our Condensed Consolidated Balance Sheets as of March 31, 2018 is presented in the table below. March 31, 2018 As Reported Under Topic 606 Adjustments If Reported Under Topic 605 Current assets: Accounts receivable, net of allowance for doubtful accounts 33,375 107 33,482 Total current assets $ 277,028 $ 107 $ 277,135 Total assets $ 444,273 $ 107 $ 444,380 Current liabilities: Deferred revenue — 3,476 3,476 Total current liabilities $ 93,422 $ 3,476 $ 96,898 Deferred revenue, less current portion — 311 311 Total liabilities $ 119,979 $ 3,787 $ 123,766 Stockholders’ equity: Accumulated deficit (495,691 ) 3,894 (491,797 ) Total stockholders’ equity 324,294 3,894 328,188 Total liabilities and stockholders’ equity $ 444,273 $ 107 $ 444,380 Had we continued to apply Topic 605 for our revenue recognition for the three months ended March 31, 2018 , the “proforma” impact to our Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2018 is presented in the table below: Three Months Ended March 31, 2018 As Reported Under Topic 606 Adjustments If Reported Under Topic 605 Net loss $ (15,816 ) $ 517 $ (15,299 ) Changes in operating assets and liabilities: Accounts receivable, net (583 ) (107 ) (690 ) Deferred revenue — (410 ) (410 ) |
Description of Business, Basi27
Description of Business, Basis of Presentation, and Operating Segment (Policies) | 3 Months Ended |
Mar. 31, 2018 | |
Accounting Policies [Abstract] | |
Description of Business | Description of Business Spectrum Pharmaceuticals, Inc. (“Spectrum”, the “Company”, “we”, “our”, or “us”) is a biopharma company, with a primary strategy comprised of acquiring, developing, and commercializing a broad and diverse pipeline of late-stage clinical and commercial products. We have an in-house clinical development organization with regulatory and data management capabilities, and a commercial infrastructure and a field sales force for our marketed products. Currently, we have six approved oncology/hematology products (FUSILEV, FOLOTYN, ZEVALIN, MARQIBO, BELEODAQ, and EVOMELA) that target different types of cancer including: non-Hodgkin’s lymphoma (“NHL”), advanced metastatic colorectal cancer, acute lymphoblastic leukemia, and multiple myeloma (“MM”). We also have three drugs in mid-to-late stage development (in Phase 2 or Phase 3 clinical trials): • Poziotinib, a novel pan-HER inhibitor used in the treatment of patients with a variety of solid tumors, including breast and lung cancer. • ROLONTIS (formerly referred to as SPI-2012 or LAPS-G-CSF) for chemotherapy-induced neutropenia; and • QAPZOLA (formerly referred to as APAZIQUONE) for immediate intravesical instillation in post-transurethral resection of bladder tumors in patients with non-muscle invasive bladder cancer (“NMIBC”). |
Basis of Presentation | Basis of Presentation Interim Financial Statements The interim financial data for the three months ended March 31, 2018 and 2017 , respectively, is unaudited, and is not necessarily indicative of our operating results for a full year. In the opinion of our management, the interim data includes normal and recurring adjustments necessary for a fair presentation of our financial results for the three months ended March 31, 2018 and 2017 . Certain information and footnote disclosures normally included in annual financial statements prepared in accordance with United States generally accepted accounting principles (“GAAP”) have been condensed or omitted pursuant to the United States Securities and Exchange Commission (“SEC”) rules and regulations relating to interim financial statements. The December 31, 2017 balances reported herein are derived from the audited Consolidated Financial Statements included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2017 . The accompanying Condensed Consolidated Financial Statements should be read in conjunction with our audited Consolidated Financial Statements and Notes thereto included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2017 , filed with the SEC on March 7, 2018 . Principles of Consolidation The accompanying Condensed Consolidated Financial Statements have been prepared in accordance with GAAP and with the rules and regulations of the 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 Spectrum Pharma Canada (“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 SPC, a legal entity organized in Quebec, Canada in January 2008. Some of our clinical studies are conducted through this “variable interest entity” (as defined under applicable GAAP). We fund all of SPC’s operating costs, and since we assume all risks and rewards for this entity, we meet the criteria as being its “primary beneficiary.” Accordingly, SPC’s balance sheets and statements of operations are included in our Condensed 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 three months ended March 31, 2018 and 2017 , 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 United States. |
Revenue Recognition | Revenue Recognition Impact of the New Revenue Recognition Standard : ASU No. 2014-09 , Revenue from Contracts with Customers (“Topic 606”), became effective for us on January 1, 2018. Our disclosure within the below sections to this footnote reflects our updated accounting policies that are affected by this new standard. We applied the “modified retrospective” transition method for open contracts for the implementation of Topic 606; this resulted in the recognition of an aggregate $4.7 million , net of tax, decrease to our January 1, 2018 “accumulated deficit” on our accompanying Condensed Consolidated Balance Sheets for the cumulative impact of applying this new standard. We made no adjustments to our previously-reported total revenues, as those periods continue to be presented in accordance with our historical accounting practices under Topic 605, Revenue Recognition . See Notes 4, 5, and 19 for additional quantitative and qualitative revenue disclosures in accordance with Topic 606. Required Elements of Our Revenue Recognition : Revenue from our (a) product sales, (b) out-license arrangements, and (c) service arrangements is recognized under Topic 606 in a manner that reasonably reflects the delivery of our goods and/or services to customers in return for expected consideration and includes the following elements: (1) we ensure that we have an executed contract(s) with our customer that we believe is legally enforceable; (2) we identify the “performance obligations” in the the respective contract; (3) we determine the “transaction price” for each performance obligation in the the respective contract; (4) we allocate the transaction price to each performance obligation; and (5) we recognize revenue only when we satisfy each performance obligation. These five elements, as applied to each of our three revenue categories, are summarized below: (a) Product Sales : We sell our products to pharmaceutical 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 our product sales is recognized as physical delivery of product occurs (when our customer obtains control of the product), in return for agreed-upon consideration. Our gross product sales (i.e., delivered units multiplied by the contractual price per unit) are reduced by our corresponding gross-to-net (“GTN”) estimates using the “expected value” method, resulting in our reported “product sales, net” in the accompanying Condensed Consolidated Statements of Operations, reflecting the amount we ultimately expect to realize in net cash proceeds, taking into account our current period gross sales and related cash receipts, and the subsequent cash disbursements on these sales that we estimate for the various GTN categories discussed below. These estimates are based upon information received from external sources (such as written or oral information obtained from our customers with respect to their period-end inventory levels and sales to end-users during the period), in combination with management’s informed judgments. Due to the inherent uncertainty of these estimates, the actual amount incurred (of some, or all) of product returns, government chargebacks, prompt pay discounts, commercial rebates, Medicaid rebates, and distribution, data, and GPO administrative fees may be materially above or below the amount estimated, then requiring prospective adjustments to our reported net product sales. These GTN estimate categories are each discussed below: Product Returns Allowances : Our FUSILEV, MARQIBO, and BELEODAQ customers are contractually permitted to return purchased products beginning at its expiration date and within six months thereafter. Our EVOMELA customers are permitted to return purchased product beginning at six months prior to its expiration date, and within 12 months thereafter (as well as for overstock inventory, as determined by end-users). ZEVALIN and FOLOTYN returns for expiry are not contractually permitted. Returns outside of this aforementioned criteria are not customarily allowed. We estimate expected product returns for our allowance based on our historical return rates. Returned product is typically destroyed, since substantially all returns are due to expiry and cannot be resold. 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 : Our out-license arrangements allow licensees to market our product(s) in certain territories for a specific term (representing the out-license of “functional intellectual property”). These arrangements may include one or more of the following forms of consideration: (a) upfront license fees, (b) sales royalties, (c) sales milestone-achievement fees, and (d) regulatory milestone-achievement fees. We recognize revenue for each based on the contractual terms that establish our right to collect payment once the performance obligation is achieved, as follows: (a) Upfront license fees : We determine whether upfront license fees are earned at the time of contract execution (i.e., when rights transfer to the customer) or over the actual (or implied) contractual period of the out-license. As part of this determination, we evaluate whether we have any other requirements to provide substantive services that are inseparable from the performance obligation of the license transfer. Our customers’ “distinct” rights to licensed “functional intellectual property” at the time of contract execution results in concurrent revenue recognition of all upfront license fees (assuming that there are no other performance obligations at contract execution that are inseparable from this license transfer). (b) Royalties : Under the “sales-or-usage-based royalty exception” we recognize revenue in the same period that our licensees complete product sales in their territory for which we are contractually entitled to a percentage-based royalty receipt. (c) Sales milestones : Under the “sales-or-usage-based royalty exception” we recognize revenue in full within the period that our licensees achieve annual or aggregate product sales levels in their territories for which we are contractually entitled to a specified lump-sum receipt. (d) Regulatory milestones : Under the terms of the respective out-license, regulatory achievements may either be our responsibility, or that of our licensee. • When our licensee is responsible for the achievement of the regulatory milestone, we recognize revenue in full (for the contractual amount due from our licensee) in the period that the approval occurs (i.e., when the “performance obligation” is satisfied by our customer) under the “most likely amount” method. This revenue recognition remains “constrained” until regulatory approval occurs, given its inherent uncertainty and the requirement of a significant revenue reversal not being probable if achievement does not occur. At each reporting period, we re-evaluate the probability of milestone achievement and the associated revenue constraint; any resulting adjustments would be recorded on a cumulative catch-up basis, thus reflected in our financial statements in the period of adjustment. • When we are responsible for the achievement of a regulatory milestone, the “relative selling price method” is applied for purposes of allocating the transaction price to our performance obligations. In such case, we consider (i) the extent of our effort to achieve the milestone and/or the enhancement of the value of the delivered item(s) as a result of milestone achievement and (ii) if the milestone payment is reasonable relative to all of the deliverables and payment terms (including other potential milestone consideration) within the arrangement. We have historically assessed the contractual value of these milestones upon their achievement to be identical to the allocation of value of our performance obligations and thus representing the “transaction price” for each milestone at contract inception. We recognize this revenue in the period that the regulatory approval occurs (i.e., when we complete the “performance obligation”) under the “most likely amount” method, and revenue recognition is otherwise “constrained” until regulatory approval occurs, given its inherent uncertainty and the requirement of a significant revenue reversal not being probable if achievement does not occur. At each reporting period, we re-evaluate the probability of milestone achievement and the associated revenue constraint; any resulting adjustments would be recorded on a cumulative catch-up basis, thus reflected in our financial statements in the period of adjustment. (c) Service Revenue : We receive fees under certain arrangements for (a) sales and marketing services, (b) supply chain services (c) research and development services, and (d) clinical trial management services. Our rights to receive payment for these services may be established by (i) a fixed-fee schedule that covers the term of the arrangement, so long as we meet ongoing performance obligations, (ii) our completion of product delivery in our capacity as a procurement agent, (iii) the successful completion of a phase of drug development, (iv) favorable results from a clinical trial, and/or (v) regulatory approval events. We consider whether revenue associated with these service arrangements is reportable each period, based on our completed services or deliverables (i.e., satisfied “performance obligations”) during the reporting period, and the terms of the arrangement that contractually result in fixed payments due to us. The promised service(s) within these arrangements are distinct and explicitly stated within each contract, and our customer benefits from the separable service(s) delivery/completion. Further, the nature of the promise to our customer as stated within the respective contract is to deliver each named service individually (not a transfer of combined items to which the promised goods or services are inputs), and thus are separable for revenue recognition. |
Cash and Cash 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 equity securities (beginning January 1, 2018 - see Note 3(a) ), mutual funds, and bank certificates of deposit (“Bank CDs”). Beginning January 1, 2018, our realized and unrealized gains (losses) on marketable securities are included in “ Other income, net ” on the accompanying Condensed Consolidated Statements of Operations. Prior to January 1, 2018, our unrealized gains (losses) were included in “other comprehensive (loss) income” on our accompanying Condensed Consolidated Statements of Comprehensive Loss. |
Accounts Receivable | Accounts Receivable Our accounts receivables are derived from our product sales and license fees (our service revenue is recorded in “other receivables”), and do not bear interest. The allowance for doubtful accounts is management’s best estimate of the amount of probable credit losses in our existing accounts receivable. Account balances are charged off against the allowance after appropriate collection efforts are exhausted. |
Inventories | Inventories We value our inventory at the lower of (i) the actual cost of its purchase or manufacture, or (ii) its net realizable value. Inventory cost is determined on the first-in, first-out method. 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 of each product lot. Manufacturing costs of drug products that are pending U.S. Food and Drug Administration (“FDA”) approval are expensed through “research and development,” on the accompanying Condensed Consolidated Statements of Operations (rather than being capitalized to “inventories”). |
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 our 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 1 st ), 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 prior to vesting, though is ultimately adjusted for actual forfeitures. 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, though recognized expense is ultimately adjusted for actual forfeitures. 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 our stock options, (c) our stock price volatility over its expected term (and that of our designated peer group with respect to certain market-based awards), and (d) the risk-free interest rate over the expected term. 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. Department of the Treasury yields in effect at award grant, for a period equaling the expected term of the stock option. |
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) income” in the Condensed 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) income” in the Condensed Consolidated Balance Sheets. All unrealized foreign exchange gains and losses associated with our intercompany loans are included in “accumulated other comprehensive (loss) income” in the Condensed Consolidated Balance Sheets, as these loans with our foreign subsidiaries are not expected to be settled in the “foreseeable future.” |
Basic and Diluted Net Loss per Share | Basic and Diluted Net Loss per Share We calculate basic and diluted net loss 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 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) benefit for income taxes” within the Condensed Consolidated Statements of Operations for the period in which we received the notice. |
Research and Development Costs | Research and Development Costs Our research and development costs are expensed as incurred, or as certain milestone payments become due, which are 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. |
Balance Sheet Account Detail (T
Balance Sheet Account Detail (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Cash And Cash Equivalent Marketable Securities Unrealized Gain Table | The following is a summary of our presented “cash and cash equivalents” and “marketable securities”: Cost Foreign Currency Translation Gross Gross Estimated Cash and Cash Marketable Securities March 31, 2018 Equity securities* (see Note 3(g) and Note 10 ) $ 8,710 $ (174 ) $ 39,618 $ — $ 48,154 $ — $ 48,154 Bank deposits 20,546 — — — 20,546 20,546 — Money market funds 162,967 — — — 162,967 162,967 — Bank certificates of deposits 249 — — — 249 — 249 Total cash and cash equivalents and marketable securities $ 192,472 $ (174 ) $ 39,618 $ — $ 231,916 $ 183,513 $ 48,403 December 31, 2017 Bank deposits $ 10,965 $ — $ — $ — $ 10,965 $ 10,965 $ — Money market funds 216,358 — — — 216,358 216,358 — Bank certificates of deposits 248 — — — 248 — 248 Total cash and cash equivalents and marketable securities $ 227,571 $ — $ — $ — $ 227,571 $ 227,323 $ 248 * Beginning January 1, 2018, under the new requirements of ASU 2016-01, Recognition and Measurement of Financial Assets and Liabilities , the unrealized gains on our equity securities in CASI Pharmaceuticals, Inc. (NASDAQ: CASI) (“CASI”) are recognized as an increase to “other income, net” on the Consolidated Statements of Operations (rather than through “other comprehensive (loss) income” on the Consolidated Statements of Comprehensive Loss). Our adoption of ASU 2016-01 on January 1, 2018, resulted in a $17.2 million cumulative-effect adjustment, net of income tax, recorded as a decrease to “accumulated other comprehensive (loss) income” and a decrease to “accumulated deficit” on the accompanying Condensed Consolidated Balance Sheets. Our recognized unrealized gain on these equity securities was $10.2 million for the three months ended March 31, 2018 , as reported in “other income, net” on the accompanying Condensed Consolidated Statements of Operations. |
Schedule of Property and Equipment Net of Accumulated Depreciation | “Property and equipment, net of accumulated depreciation” consists of the following: March 31, 2018 December 31, 2017 Computer hardware and software $ 3,067 $ 2,994 Laboratory equipment 630 630 Office furniture 218 218 Leasehold improvements 2,938 2,938 Property and equipment, at cost 6,853 6,780 (Less): Accumulated depreciation (6,260 ) (6,191 ) Property and equipment, net of accumulated depreciation $ 593 $ 589 |
Components of Inventories | “Inventories” consists of the following: March 31, 2018 December 31, 2017 Raw materials $ 1,251 $ 1,077 Work-in-process 2,576 2,551 Finished goods 4,332 5,187 (Less:) Non-current portion of inventories included within "other assets" * (3,131 ) (3,100 ) Inventories $ 5,028 $ 5,715 * The “non-current” portion of inventories is presented within “other assets” in the accompanying Condensed Consolidated Balance Sheets at March 31, 2018 and December 31, 2017 , respectively. This value of $3.1 million at March 31, 2018 represents product that we expect to sell beyond March 31, 2019 and the value at December 31, 2017 represents product that we expect to sell beyond December 31, 2018 . . |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure | “Prepaid expenses and other assets” consists of the following: March 31, 2018 December 31, 2017 Other miscellaneous prepaid operating expenses $ 3,148 $ 3,389 Prepaid insurance 603 645 Research and development supplies 52 1,883 Key employee life insurance - cash surrender value — 4,150 Prepaid expenses and other assets $ 3,803 $ 10,067 |
Schedule of Other Receivables | “Other receivables” consists of the following: March 31, 2018 December 31, 2017 Other miscellaneous receivables* $ 992 $ 1,152 Income tax receivable 637 665 Insurance receivable 1,095 53 Reimbursements due from development partners for incurred research and development expenses 182 263 Other receivables $ 2,906 $ 2,133 * As of March 31, 2018 and December 31, 2017 , the balance is inclusive of $0.4 million and $0.4 million , respectively, of Medicaid rebate credits to be applied against future invoices for each respective state program, and $0.2 million and $0.4 million , respectively, of royalty receivables from Mundipharma International Corporation Limited (“Mundipharma”) for sales of ZEVALIN in Japan. |
Components of Intangible Assets Net of Accumulated Amortization | Intangible assets, net of accumulated amortization and impairment charges consists of the following: March 31, 2018 Historical Accumulated Foreign Impairment Net Amount Full Remaining MARQIBO IPR&D (NHL and other novel indications) $ 17,600 $ — $ — $ — $ 17,600 n/a n/a EVOMELA distribution rights (1) 7,700 (1,185 ) — — 6,515 156 132 BELEODAQ distribution rights 25,000 (7,031 ) — — 17,969 160 115 MARQIBO distribution rights 26,900 (18,262 ) — — 8,638 81 24 FOLOTYN distribution rights (2) 118,400 (57,380 ) — — 61,020 152 56 ZEVALIN distribution rights – U.S. 41,900 (38,426 ) — — 3,474 123 12 ZEVALIN distribution rights – ex-U.S. 23,490 (18,157 ) (1,871 ) — 3,462 96 24 FUSILEV distribution rights (3) 16,778 (9,618 ) — (7,160 ) — 56 0 FOLOTYN out-license (4) 27,900 (15,236 ) — (1,023 ) 11,641 110 52 Total intangible assets $ 305,668 $ (165,295 ) $ (1,871 ) $ (8,183 ) $ 130,319 (1) The FDA approval of EVOMELA in March 2016 triggered a $6 million payment due to CyDex Pharmaceuticals, Inc. (a wholly-owned subsidiary of Ligand Pharmaceuticals Incorporated (“Ligand”) (“Cydex”)). This event also resulted in a reclassification of our $7.7 million “EVOMELA IPR&D” to “EVOMELA distribution rights” due to our ability to begin commercialization of EVOMELA upon FDA approval. Amortization commenced on April 1, 2016, in accordance with our capitalization policy for intangible assets. (2) Beginning June 2016, we adjusted the amortization period of our FOLOTYN distribution rights to November 2022 from March 2025, representing the period through which we expect to have patent protection from generic competition (see Note 16(g) ). (3) On February 20, 2015, the United States 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 in 2015 for the then remaining net book value of FUSILEV distribution rights. (4) On May 29, 2013, we amended our FOLOTYN collaboration agreement with Mundipharma. As a result of the amendment, Europe and Turkey were excluded from Mundipharma’s commercialization territory, and their royalty rates and milestone payments to us were modified. This constituted a change under which we originally valued the FOLOTYN out-license as part of business combination accounting, resulting in an impairment charge (non-cash) of $1.0 million in the second quarter of 2013. December 31, 2017 Historical Accumulated Foreign Impairment Net Amount MARQIBO IPR&D (NHL and other novel indications) $ 17,600 $ — $ — $ — $ 17,600 EVOMELA distribution rights 7,700 (1,037 ) — — 6,663 BELEODAQ distribution rights 25,000 (6,563 ) — — 18,437 MARQIBO distribution rights 26,900 (17,182 ) — — 9,718 FOLOTYN distribution rights 118,400 (54,111 ) — — 64,289 ZEVALIN distribution rights – U.S. 41,900 (37,557 ) — — 4,343 ZEVALIN distribution rights – Ex-U.S. 23,490 (17,232 ) (2,471 ) — 3,787 FUSILEV distribution rights 16,778 (9,618 ) — (7,160 ) — FOLOTYN out-license 27,900 (14,555 ) — (1,023 ) 12,322 Total intangible assets $ 305,668 $ (157,855 ) $ (2,471 ) $ (8,183 ) $ 137,159 |
Estimated Intangible Asset Amortization Expense | Estimated intangible asset amortization expense for the remainder of 2018 and the five succeeding fiscal years and thereafter is as follows: Years Ending December 31, Remainder of 2018 $ 20,843 2019 25,185 2020 19,779 2021 18,266 2022 15,882 2023 2,467 2024 and thereafter 10,297 $ 112,719 |
Schedule of Goodwill | “Goodwill” consists of the following: March 31, 2018 December 31, 2017 Acquisition of Talon (MARQIBO rights) $ 10,526 $ 10,526 Acquisition of ZEVALIN Ex-U.S. distribution rights 2,525 2,525 Acquisition of Allos (FOLOTYN rights) 5,346 5,346 Foreign currency exchange translation effects (170 ) (235 ) Goodwill $ 18,227 $ 18,162 |
Summary of Other Assets | “Other assets” consists of the following: March 31, 2018 December 31, 2017 Equity securities (see Note 10 )* $ — $ 37,530 Key employee life insurance – cash surrender value 11,463 10,737 Inventories - non-current portion 3,131 3,100 Promissory note receivable - long term (see Note 10 ) 1,519 1,517 Income tax receivable** 668 668 Research & development supplies and other 1,325 231 Other assets $ 18,106 $ 53,783 * As of March 31, 2018, we reclassified our presentation of these equity securities from this account caption to “marketable securities” on the face of our accompanying Condensed Consolidated Balance Sheets - see Note 3(a) . ** This value represents the non-current portion of the refundable alternative minimum tax credit that is expected to be received over the next few years (see Note 16 ). |
Schedule of Accounts Payable and Other Accrued Liabilities | “Accounts payable and other accrued liabilities” consists of the following : March 31, 2018 December 31, 2017 Trade accounts payable and other accrued liabilities $ 29,549 $ 33,648 Accrued rebates 7,713 7,990 Accrued product royalty 3,868 4,339 Allowance for returns 4,549 4,045 Accrued data and distribution fees 2,530 4,305 Accrued GPO administrative fees 312 296 Accrued inventory management fee 560 1,126 Allowance for chargebacks 1,846 2,368 Accounts payable and other accrued liabilities $ 50,927 $ 58,117 |
Schedule of Amounts Presented in Accounts Payable and Other Accrued Liabilities | Amounts presented within “accounts payable and other accrued liabilities” in the accompanying Condensed Consolidated Balance Sheets for our categories of GTN estimates (see Note 2(i) ) were as follows: Commercial/Medicaid Rebates and Government Chargebacks Distribution, Data, and Product Return Allowances Balance as of December 31, 2016 $ 9,817 $ 5,146 $ 2,309 Add: provisions 106,647 20,104 2,807 (Less): credits or actual allowances (106,106 ) (19,523 ) (1,071 ) Balance as of December 31, 2017 10,358 5,727 4,045 Add: provisions 13,805 3,425 468 (Less): credits or actual allowances (14,604 ) (5,750 ) 36 Balance as of March 31, 2018 $ 9,559 $ 3,402 $ 4,549 |
Deferred Revenue, by Arrangement, Disclosure | Deferred revenue (current and non-current) consists of the following: March 31, 2018 December 31, 2017 EVOMELA deferred revenue $ — $ 3,819 ZEVALIN out-license in India territory (see Note 15(b)(iii) ) — 368 Deferred revenue* $ — $ 4,187 * On January 1, 2018, we reclassified the deferred revenue related to our EVOMELA product sales and our ZEVALIN out-license in the India territory of $3.8 million and $0.4 million , respectively. These amounts were included in the $4.7 million aggregate decrease to “accumulated deficit” on January 1, 2018, in accordance with the adoption of Topic 606 (see Note 2(i) ). |
Summary of Other Long-Term Liabilities | “Other long-term liabilities” consists of the following: March 31, 2018 December 31, 2017 Accrued executive deferred compensation $ 5,981 $ 5,928 Deferred rent (non-current portion) 20 52 Clinical study holdback fees, non-current 62 59 Other tax liabilities 176 176 Royalty liability 300 — Other long-term liabilities $ 6,539 $ 6,215 |
Gross-to-Net Product Sales (Tab
Gross-to-Net Product Sales (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Revenue, Net [Abstract] | |
Reconciliation of Gross to Net Product Sales | The below table presents a GTN (see Note 2(i) ) product sales reconciliation for the accompanying Condensed Consolidated Statements of Operations: Three Months Ended 2018 2017 Gross product sales $ 49,590 $ 58,217 Commercial rebates and government chargebacks (17,029 ) (27,324 ) Data and distribution fees, GPO fees, and inventory management fees (3,511 ) (4,462 ) Prompt pay discounts (390 ) (270 ) Product returns allowance (549 ) (316 ) Product sales, net $ 28,111 $ 25,845 |
Composition of Total Revenue (T
Composition of Total Revenue (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Segment Reporting [Abstract] | |
Schedule of Product Sales, Net by Geography | The below table presents our net product sales by geography for the three months ended March 31, 2018 and 2017 : Three Months Ended 2018 2017 United States $ 23,198 82.5 % $ 23,801 92.1 % International: Europe 3,489 12.4 % 2,044 7.9 % Asia Pacific 1,424 5.1 % — — % Total international 4,913 17.5 % 2,044 7.9 % Product sales, net $ 28,111 100.0 % $ 25,845 100.0 % |
Schedule Of Net Sales By Product Line Table | The below table presents our net sales by product for the three months ended March 31, 2018 and 2017 : Three Months Ended 2018 2017 FOLOTYN $ 12,721 45.3 % $ 9,274 35.9 % EVOMELA 8,134 28.9 % 6,301 24.4 % BELEODAQ 2,713 9.7 % 2,871 11.1 % ZEVALIN 3,025 10.8 % 2,845 11.0 % MARQIBO 894 3.2 % 1,980 7.7 % FUSILEV 624 2.2 % 2,574 10.0 % Product sales, net $ 28,111 100.0 % $ 25,845 100.0 % The below table presents our license fees and service revenue by source for the three months ended March 31, 2018 and 2017 : Three Months Ended 2018 2017 Out-license of FOLOTYN in all countries except the United States, Canada, Europe, and Turkey: royalties ( Note 14 ) $ 377 15.8 % $ 263 8.1 % Out-license of ZEVALIN: recognition of milestone achievement, upfront cash receipt and subsequent royalties for Asia and certain other territories, excluding China ( Note 11 ) 2,001 83.9 % 615 18.9 % Out-license of ZEVALIN: amortization of upfront cash receipt related to India territory ( Note 15(b)(iii) ) and other — — % 12 0.4 % Out-license of ZEVALIN, FOLOTYN, BELEODAQ, MARQIBO: upfront cash receipt and subsequent royalties for the Canada territory ( Note 15(b)(xiv) ) 6 0.3 % — — % Sales and marketing contracted services ( Note 12 ) — — % 2,366 72.7 % License fees and service revenues $ 2,384 100.0 % $ 3,256 100.0 % |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
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 the three months ended March 31, 2018 and 2017 , was as follows (see Note 18 for a discussion of certain immaterial corrections affecting the presented 2017 amounts below): Three Months Ended 2018 2017 Cost of sales $ 66 $ 30 Selling, general and administrative 3,691 3,238 Research and development 721 452 Total stock-based compensation $ 4,478 $ 3,720 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Earnings Per Share [Abstract] | |
Computation of 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 three months ended March 31, 2018 and 2017 : Three Months Ended 2018 2017 Net loss $ (15,816 ) $ (23,547 ) Weighted average shares – basic and diluted 100,809,853 78,523,023 Net loss per share – basic and diluted $ (0.16 ) $ (0.30 ) |
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 under the “treasury stock method” and “if-converted method” would have been anti-dilutive due to our net loss per share in the three months ended March 31, 2018 and 2017 , as summarized below: Three Months Ended 2018 2017 2018 Convertible Notes 3,854,959 10,454,799 Common stock options 5,589,852 1,557,920 Restricted stock awards 1,875,569 1,769,530 Restricted stock units 210,214 217,206 Common stock warrants 261,622 — Employee stock purchase plan shares 24,064 53,927 Total 11,816,280 14,053,382 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
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 Condensed Consolidated Balance Sheets, and their designations among three fair value measurement categories (see Note 2(xiii)) : March 31, 2018 Level 1 Level 2 Level 3 Total Assets: Bank certificates of deposits $ — $ 249 $ — $ 249 Money market funds — 162,967 — 162,967 Equity securities ( Note 3(a) ) 48,154 — — 48,154 Mutual funds — 59 — 59 Deferred compensation investments (life insurance cash surrender value - Note 3(g) ) — 11,463 — 11,463 * $ 48,154 $ 174,738 $ — $ 222,892 Liabilities: Deferred executive compensation liability ( Note 15(f) ) $ — $ 10,168 $ — $ 10,168 * Drug development liability ( Note 14 ) — — 12,283 12,283 Talon CVR ( Note 9(a) ) — — 6,501 6,501 Corixa Liability ( Note 15(b)(i) ) — — 62 62 $ — $ 10,168 $ 18,846 $ 29,014 December 31, 2017 Level 1 Level 2 Level 3 Total Assets: Bank certificates of deposits $ — $ 248 $ — $ 248 Money market funds — 216,358 — 216,358 Equity securities ( Note 10 ) 37,530 — — 37,530 Mutual funds — 59 — 59 Deferred compensation investments (life insurance cash surrender value) — 14,887 — 14,887 * $ 37,530 $ 231,552 $ — $ 269,082 Liabilities: Deferred executive compensation liability ( Note 15(f) ) $ — $ 11,038 $ — $ 11,038 * Drug development liability ( Note 14 ) — — 12,386 12,386 Talon CVR ( Note 9(a) ) — — 6,210 6,210 Corixa Liability ( Note 15(b)(i) ) — — 62 62 $ — $ 11,038 $ 18,658 $ 29,696 * The reported value of “deferred compensation investments” is based on the cash surrender value of the life insurance policies, while the value of the “deferred executive compensation liability” is based on the market value of the underlying investment holdings. |
Fair Value Measurement Activity for Liabilities Utilize Level 3 Inputs | The table below summarizes the 2017 and 2018 activity of our liabilities that are valued with unobservable inputs: Fair Value Measurements of Balance as of December 31, 2016 $ 14,445 FOLOTYN development liability (see Note 14 ) (744 ) Talon CVR fair value adjustment - MARQIBO (see Note 9(a) ) 4,957 Balance as of December 31, 2017 18,658 FOLOTYN development liability (see Note 14 ) (103 ) Talon CVR fair value adjustment - MARQIBO (see Note 9(a) ) 291 Balance as of March 31, 2018 $ 18,846 * This amount is comprised of the current and non-current portions of “FOLOTYN development liability” and the non-current portion of “acquisition-related contingent obligations” on our accompanying Condensed Consolidated Balance Sheets. |
Business Combinations and Con34
Business Combinations and Contingent Consideration (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Talon Therapeutics, Inc. [Member] | |
Business Acquisition [Line Items] | |
Change in Fair Value of Contingent Consideration Related to Acquisitions | Fair Value December 31, 2017 $ 6,210 Fair value adjustment for the three months ended March 31, 2018 291 March 31, 2018 $ 6,501 |
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] | |
Business Acquisition [Line Items] | |
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: EVOMELA IPR&D rights $ 7,700 |
Out-License of Marqibo, Zeval35
Out-License of Marqibo, Zevalin, & Evolema in China Territory (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Other Commitments [Abstract] | |
Schedule of Proceeds Received and Fair Value on CASI Out-License Execution Date | The proceeds we received in 2014, 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, 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. (b) Value estimated using the terms of the $1.5 million promissory note, the application of a synthetic debt rating based on CASI’s publicly-available financial information, and the prevailing interest yields on similar public debt securities as of September 17, 2014. This full balance was reclassified beginning December 31, 2017 to “other assets” (presented within non-current assets on the accompanying Condensed Consolidated Balance Sheets) from “other receivables” (presented within current assets) due to an amended maturity date of September 17, 2019. (c) Presented within “license fees and service revenue” in the Consolidated Statements of Operations for the year ended December 31, 2015 (see below). |
Convertible Senior Notes (Table
Convertible Senior Notes (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Debt Disclosure [Abstract] | |
Carrying Value of 2018 Convertible Notes | The carrying value of the 2018 Convertible Notes as of March 31, 2018 and December 31, 2017 , is summarized as follows: March 31, 2018 December 31, 2017 Principal amount $ 40,565 $ 40,565 (Less): Unamortized debt discount (amortized through December 2018) (1,568 ) (2,101 ) (Less): Debt issuance costs (178 ) (240 ) Carrying value $ 38,819 $ 38,224 |
Components of the Interest Expense Recognized | The following table sets forth the components of interest expense recognized in the accompanying Condensed Consolidated Statements of Operations for the 2018 Convertible Notes for the three months ended March 31, 2018 and 2017 : Three Months Ended 2018 2017 Contractual coupon interest expense $ 279 $ 757 Amortization of debt issuance costs 61 166 Accretion of debt discount 533 1,381 Total $ 873 $ 2,304 Effective interest rate 8.41 % 8.65 % |
FOLOTYN License Agreement And37
FOLOTYN License Agreement And Development Liability (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Business Combinations [Abstract] | |
Schedule of Drug Development Liability Adjustments | FOLOTYN FOLOTYN FOLOTYN Balance as of December 31, 2017 $ 275 $ 12,111 $ 12,386 Transfer from long-term to current in 2018 103 (103 ) — (Less): Expenses incurred in 2018 (103 ) — (103 ) Balance as of March 31, 2018 $ 275 $ 12,008 $ 12,283 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Equity [Abstract] | |
Summary of Shares Sold and Issued | We sold and issued shares of our common stock under both the December 2015 ATM Agreement and August 2017 ATM Agreement, summarized as follows: Description of Financing Transaction No. of Common Shares Issued Proceeds Received (Net of Broker Commissions and Fees ) Common shares issued pursuant to the December 2015 ATM Agreement during the year ended December 31, 2016 10,890,915 $ 73,869 Common shares issued pursuant to the December 2015 ATM Agreement between July 1, 2017 and July 31, 2017 3,243,882 $ 23,745 Common shares issued pursuant to the August 2017 ATM Agreement between August 1, 2017 and December 31, 2017 10,314,250 $ 104,527 |
Immaterial Restatement Of Pri39
Immaterial Restatement Of Prior Period Financial Statements For Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Accounting Changes and Error Corrections [Abstract] | |
Schedule of error corrections and prior period adjustments | Restated Condensed Consolidated Statements of Operations for the three months ended March 31, 2017 : Three Months Ended March 31, 2017 As Previously Reported As Restated Operating costs and expenses: Selling, general and administrative $ 18,607 $ 19,104 Research and development 14,696 14,779 Total operating costs and expenses 50,430 51,010 Loss from operations (21,329 ) (21,909 ) Loss before income taxes (23,168 ) (23,748 ) Net loss $ (22,967 ) $ (23,547 ) Net loss per share: Basic $ (0.29 ) $ (0.30 ) Diluted $ (0.29 ) $ (0.30 ) Restated Condensed Consolidated Statements of Comprehensive Loss for the three months ended March 31, 2017 : Three Months Ended March 31, 2017 As Previously Reported As Restated Net loss $ (22,967 ) $ (23,547 ) Total comprehensive loss $ (21,008 ) $ (21,588 ) |
Implementation of New Revenue40
Implementation of New Revenue Recognition Standard on January 1, 2018 (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Revenue from Contract with Customer [Abstract] | |
Schedule of New Accounting Pronouncements and Changes in Accounting Principles | Had we continued to apply Topic 605 for our revenue recognition for the three months ended March 31, 2018 , the “proforma” impact to our Condensed Consolidated Statements of Operations is presented in the table below: Three Months Ended March 31, 2018 As Reported Under Topic 606 Adjustments If Reported Under Topic 605 Revenue: Product sales, net $ 28,111 $ 397 $ 28,508 License fees and service revenue 2,384 120 2,504 Total revenues $ 30,495 $ 517 $ 31,012 Loss from operations (25,264 ) 517 (24,747 ) Loss before income taxes (15,813 ) 517 (15,296 ) Net loss $ (15,816 ) $ 517 $ (15,299 ) Net loss per share: Basic and Diluted $ (0.16 ) $ 0.01 $ (0.15 ) Had we continued to apply Topic 605 for our revenue recognition for the three months ended March 31, 2018 , the “proforma” impact to our Condensed Consolidated Balance Sheets as of March 31, 2018 is presented in the table below. March 31, 2018 As Reported Under Topic 606 Adjustments If Reported Under Topic 605 Current assets: Accounts receivable, net of allowance for doubtful accounts 33,375 107 33,482 Total current assets $ 277,028 $ 107 $ 277,135 Total assets $ 444,273 $ 107 $ 444,380 Current liabilities: Deferred revenue — 3,476 3,476 Total current liabilities $ 93,422 $ 3,476 $ 96,898 Deferred revenue, less current portion — 311 311 Total liabilities $ 119,979 $ 3,787 $ 123,766 Stockholders’ equity: Accumulated deficit (495,691 ) 3,894 (491,797 ) Total stockholders’ equity 324,294 3,894 328,188 Total liabilities and stockholders’ equity $ 444,273 $ 107 $ 444,380 Had we continued to apply Topic 605 for our revenue recognition for the three months ended March 31, 2018 , the “proforma” impact to our Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2018 is presented in the table below: Three Months Ended March 31, 2018 As Reported Under Topic 606 Adjustments If Reported Under Topic 605 Net loss $ (15,816 ) $ 517 $ (15,299 ) Changes in operating assets and liabilities: Accounts receivable, net (583 ) (107 ) (690 ) Deferred revenue — (410 ) (410 ) |
Description of Business, Basi41
Description of Business, Basis of Presentation, and Operating Segment - Additional Information (Detail) | 3 Months Ended |
Mar. 31, 2018Segmentproduct | |
Segment Reporting Information [Line Items] | |
Number of late stage development products | 3 |
Number of reportable operating segment | Segment | 1 |
Spectrum Pharma Canada [Member] | |
Segment Reporting Information [Line Items] | |
Ownership interest, percentage | 50.00% |
Cancer Drugs [Member] | |
Segment Reporting Information [Line Items] | |
Number of products for sale | 6 |
Summary of Significant Accoun42
Summary of Significant Accounting Policies and Use of Estimates - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2018 | Jan. 01, 2018 | Dec. 31, 2017 | |
Accounting Policies [Line Items] | |||
Increase (decrease) in retained earnings due to revenue recognition | $ (495,691) | $ (502,107) | |
Cash and equivalents maturities period | 3 months | ||
FUSILEV, MARQIBO, and BELEODAQ [Member] | |||
Accounting Policies [Line Items] | |||
Number of months customers are allowed to return products | 6 months | ||
EVOMELA [Member] | |||
Accounting Policies [Line Items] | |||
Number of months customers are allowed to return products | 12 months | ||
Number of months prior to product expiration during which customer can return product | 6 months | ||
Difference between Revenue Guidance in Effect before and after Topic 606 [Member] | Accounting Standards Update 2014-09 [Member] | |||
Accounting Policies [Line Items] | |||
Increase (decrease) in retained earnings due to revenue recognition | $ 3,894 | $ 4,700 |
Balance Sheet Account Detail -
Balance Sheet Account Detail - Summary of Cash and Cash Equivalents and Marketable Securities (Detail) - USD ($) $ in Thousands | 3 Months Ended | |||
Mar. 31, 2018 | Mar. 31, 2017 | Jan. 01, 2018 | Dec. 31, 2017 | |
Schedule of Investments [Line Items] | ||||
Cost of equity securities | $ 8,710 | |||
Foreign currency translation on equity securities | (174) | |||
Gross unrealized gain on equity securities | 39,618 | |||
Gross unrealized losses on equity securities | 0 | |||
Estimated fair value of equity securities | 48,154 | $ 37,530 | ||
Available-for-sale securities, amortized cost | 227,571 | |||
Available-for-sale securities, gross unrealized gain | 0 | |||
Available-for-sale securities, gross unrealized loss | 0 | |||
Cash, cash equivalents and short-term investments, amortized cost | 192,472 | |||
Cash, cash equivalents, and short-term investments | 231,916 | 227,571 | ||
Unrealized gains on marketable securities | 10,196 | $ 0 | ||
Retained Earnings [Member] | Accounting Standards Update 2016-01 [Member] | ||||
Schedule of Investments [Line Items] | ||||
Cumulative effect of new accounting principle in period of adoption | $ (17,200) | |||
AOCI Attributable to Parent [Member] | Accounting Standards Update 2016-01 [Member] | ||||
Schedule of Investments [Line Items] | ||||
Cumulative effect of new accounting principle in period of adoption | (17,200) | |||
Bank Deposits [Member] | ||||
Schedule of Investments [Line Items] | ||||
Available-for-sale, debt securities, amortized cost | 20,546 | |||
Available-for-sale, debt securities, estimated fair value | 20,546 | |||
Available-for-sale securities, amortized cost | 10,965 | |||
Available-for-sale securities, gross unrealized gain | 0 | |||
Available-for-sale securities, gross unrealized loss | 0 | |||
Available-for-sale securities | 10,965 | |||
Money market funds [Member] | ||||
Schedule of Investments [Line Items] | ||||
Available-for-sale, debt securities, amortized cost | 162,967 | |||
Available-for-sale, debt securities, estimated fair value | 162,967 | |||
Available-for-sale securities, amortized cost | 216,358 | |||
Available-for-sale securities, gross unrealized gain | 0 | |||
Available-for-sale securities, gross unrealized loss | 0 | |||
Available-for-sale securities | 216,358 | |||
Bank certificates of deposit [Member] | ||||
Schedule of Investments [Line Items] | ||||
Available-for-sale, debt securities, amortized cost | 249 | |||
Available-for-sale, debt securities, estimated fair value | 249 | |||
Available-for-sale securities, amortized cost | 248 | |||
Available-for-sale securities, gross unrealized gain | 0 | |||
Available-for-sale securities, gross unrealized loss | 0 | |||
Available-for-sale securities | 248 | |||
Cash and Cash Equivalents [Member] | ||||
Schedule of Investments [Line Items] | ||||
Cash, cash equivalents, and short-term investments | 183,513 | 227,323 | ||
Cash and Cash Equivalents [Member] | Bank Deposits [Member] | ||||
Schedule of Investments [Line Items] | ||||
Available-for-sale, debt securities, estimated fair value | 20,546 | |||
Available-for-sale securities | 10,965 | |||
Cash and Cash Equivalents [Member] | Money market funds [Member] | ||||
Schedule of Investments [Line Items] | ||||
Available-for-sale, debt securities, estimated fair value | 162,967 | |||
Available-for-sale securities | 216,358 | |||
Marketable Securities [Member] | ||||
Schedule of Investments [Line Items] | ||||
Estimated fair value of equity securities | 48,154 | |||
Cash, cash equivalents, and short-term investments | 48,403 | 248 | ||
Marketable Securities [Member] | Bank certificates of deposit [Member] | ||||
Schedule of Investments [Line Items] | ||||
Available-for-sale, debt securities, estimated fair value | $ 249 | |||
Available-for-sale securities | $ 248 |
Balance Sheet Account Detail 44
Balance Sheet Account Detail - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Securities in continuous unrealized loss position, period | longer than one year. | |
Depreciation expense | $ 49 | $ 100 |
Intangible asset amortization expense | $ 6,900 | $ 6,900 |
Balance Sheet Account Detail 45
Balance Sheet Account Detail - Schedule of Property and Equipment Net of Accumulated Depreciation (Detail) - USD ($) $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, at cost | $ 6,853 | $ 6,780 |
(Less): Accumulated depreciation | (6,260) | (6,191) |
Property and equipment, net of accumulated depreciation | 593 | 589 |
Computer hardware and software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, at cost | 3,067 | 2,994 |
Laboratory equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, at cost | 630 | 630 |
Office furniture [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, at cost | 218 | 218 |
Leasehold improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, at cost | $ 2,938 | $ 2,938 |
Balance Sheet Account Detail 46
Balance Sheet Account Detail - Components of Inventories (Detail) - USD ($) $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Raw materials | $ 1,251 | $ 1,077 |
Work-in-process | 2,576 | 2,551 |
Finished goods | 4,332 | 5,187 |
(Less:) Non-current portion of inventories included within other assets | (3,131) | (3,100) |
Inventories | $ 5,028 | $ 5,715 |
Balance Sheet Account Detail 47
Balance Sheet Account Detail - Prepaid Expenses (Details) - USD ($) $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Other miscellaneous prepaid operating expenses | $ 3,148 | $ 3,389 |
Prepaid insurance | 603 | 645 |
Research and development supplies | 52 | 1,883 |
Key employee life insurance - cash surrender value | 0 | 4,150 |
Prepaid expenses and other assets | $ 3,803 | $ 10,067 |
Balance Sheet Account Detail 48
Balance Sheet Account Detail - Schedule of Other Receivables (Detail) - USD ($) $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Other miscellaneous receivables | $ 992 | $ 1,152 |
Income tax receivable | 637 | 665 |
Insurance receivable | 1,095 | 53 |
Reimbursements due from development partners for incurred research and development expenses | 182 | 263 |
Other receivables | 2,906 | 2,133 |
Medicaid rebate credit | 400 | 400 |
Royalty receivable | $ 200 | $ 400 |
Balance Sheet Account Detail 49
Balance Sheet Account Detail - Components of Intangible Assets Net of Accumulated Amortization (Detail) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||
Apr. 30, 2016 | Mar. 31, 2016 | Mar. 31, 2018 | Mar. 31, 2015 | Jun. 30, 2013 | Dec. 31, 2017 | |
Product Rights [Line Items] | ||||||
Historical Cost | $ 305,668 | $ 305,668 | ||||
Accumulated Amortization | (165,295) | (157,855) | ||||
Foreign Currency Translation | (1,871) | (2,471) | ||||
Impairment | (8,183) | (8,183) | ||||
Net Amount | 130,319 | 137,159 | ||||
Ligand Pharmaceuticals Inc [Member] | ||||||
Product Rights [Line Items] | ||||||
Milestone payments | $ 6,000 | $ 6,000 | ||||
MARQIBO IPR&D (NHL indication) [Member] | ||||||
Product Rights [Line Items] | ||||||
Historical Cost | 17,600 | 17,600 | ||||
Accumulated Amortization | 0 | 0 | ||||
Foreign Currency Translation | 0 | 0 | ||||
Impairment | 0 | 0 | ||||
Net Amount | 17,600 | 17,600 | ||||
EVOMELA distribution rights [Member] | ||||||
Product Rights [Line Items] | ||||||
Historical Cost | $ 7,700 | 7,700 | 7,700 | |||
Accumulated Amortization | (1,185) | (1,037) | ||||
Foreign Currency Translation | 0 | 0 | ||||
Impairment | 0 | 0 | ||||
Net Amount | $ 6,515 | 6,663 | ||||
Full Amortization Period (months) | 156 months | |||||
Remaining Amortization Period (months) | 132 months | |||||
BELEODAQ distribution rights [Member] | ||||||
Product Rights [Line Items] | ||||||
Historical Cost | $ 25,000 | 25,000 | ||||
Accumulated Amortization | (7,031) | (6,563) | ||||
Foreign Currency Translation | 0 | 0 | ||||
Impairment | 0 | 0 | ||||
Net Amount | $ 17,969 | 18,437 | ||||
Full Amortization Period (months) | 160 months | |||||
Remaining Amortization Period (months) | 115 months | |||||
MARQIBO distribution rights [Member] | ||||||
Product Rights [Line Items] | ||||||
Historical Cost | $ 26,900 | 26,900 | ||||
Accumulated Amortization | (18,262) | (17,182) | ||||
Foreign Currency Translation | 0 | 0 | ||||
Impairment | 0 | 0 | ||||
Net Amount | $ 8,638 | 9,718 | ||||
Full Amortization Period (months) | 81 months | |||||
Remaining Amortization Period (months) | 24 months | |||||
FOLOTYN distribution rights [Member] | ||||||
Product Rights [Line Items] | ||||||
Historical Cost | $ 118,400 | 118,400 | ||||
Accumulated Amortization | (57,380) | (54,111) | ||||
Foreign Currency Translation | 0 | 0 | ||||
Impairment | 0 | $ (1,000) | 0 | |||
Net Amount | $ 61,020 | 64,289 | ||||
Full Amortization Period (months) | 152 months | |||||
Remaining Amortization Period (months) | 56 months | |||||
ZEVALIN distribution rights [Member] | United States [Member] | ||||||
Product Rights [Line Items] | ||||||
Historical Cost | $ 41,900 | 41,900 | ||||
Accumulated Amortization | (38,426) | (37,557) | ||||
Foreign Currency Translation | 0 | 0 | ||||
Impairment | 0 | 0 | ||||
Net Amount | $ 3,474 | 4,343 | ||||
Full Amortization Period (months) | 123 months | |||||
Remaining Amortization Period (months) | 12 months | |||||
ZEVALIN distribution rights [Member] | Ex-U.S. [Member] | ||||||
Product Rights [Line Items] | ||||||
Historical Cost | $ 23,490 | 23,490 | ||||
Accumulated Amortization | (18,157) | (17,232) | ||||
Foreign Currency Translation | (1,871) | (2,471) | ||||
Impairment | 0 | 0 | ||||
Net Amount | $ 3,462 | 3,787 | ||||
Full Amortization Period (months) | 96 months | |||||
Remaining Amortization Period (months) | 24 months | |||||
FUSILEV distribution rights [Member] | ||||||
Product Rights [Line Items] | ||||||
Historical Cost | $ 16,778 | 16,778 | ||||
Accumulated Amortization | (9,618) | (9,618) | ||||
Foreign Currency Translation | 0 | 0 | ||||
Impairment | (7,160) | (7,160) | ||||
Net Amount | $ 0 | 0 | ||||
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 | ||||
Accumulated Amortization | (15,236) | (14,555) | ||||
Foreign Currency Translation | 0 | 0 | ||||
Impairment | (1,023) | (1,023) | ||||
Net Amount | $ 11,641 | $ 12,322 | ||||
Full Amortization Period (months) | 110 months | |||||
Remaining Amortization Period (months) | 52 months | |||||
FUSILEV [Member] | ||||||
Product Rights [Line Items] | ||||||
Impairment | $ (7,200) | |||||
Restatement Adjustment [Member] | EVOMELA distribution rights [Member] | ||||||
Product Rights [Line Items] | ||||||
Historical Cost | $ (7,700) |
Balance Sheet Account Detail 50
Balance Sheet Account Detail - Estimated Intangible Asset Amortization Expense (Detail) $ in Thousands | Mar. 31, 2018USD ($) |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Remainder of 2018 | $ 20,843 |
2,019 | 25,185 |
2,020 | 19,779 |
2,021 | 18,266 |
2,022 | 15,882 |
2,023 | 2,467 |
2024 and thereafter | 10,297 |
Intangible assets, net total | $ 112,719 |
Balance Sheet Account Detail 51
Balance Sheet Account Detail - Schedule of Goodwill (Detail) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2018 | Dec. 31, 2017 | |
Goodwill [Line Items] | ||
Foreign currency exchange translation effects | $ (170) | $ (235) |
Goodwill | 18,227 | 18,162 |
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 52
Balance Sheet Account Detail - Summary of Other Assets (Detail) - USD ($) $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Equity securities | $ 0 | $ 37,530 |
Key employee life insurance – cash surrender value | 11,463 | 10,737 |
Inventories - non-current portion | 3,131 | 3,100 |
Promissory note receivable - long term (see Note 10) | 1,519 | 1,517 |
Income tax receivable | 668 | 668 |
Research & development supplies and other | 1,325 | 231 |
Other assets | $ 18,106 | $ 53,783 |
Balance Sheet Account Detail 53
Balance Sheet Account Detail - Schedule of Accounts Payable and Other Accrued Liabilities (Detail) - USD ($) $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Trade accounts payable and other accrued liabilities | $ 29,549 | $ 33,648 |
Accrued rebates | 7,713 | 7,990 |
Accrued product royalty | 3,868 | 4,339 |
Allowance for returns | 4,549 | 4,045 |
Accrued data and distribution fees | 2,530 | 4,305 |
Accrued GPO administrative fees | 312 | 296 |
Accrued inventory management fee | 560 | 1,126 |
Allowance for chargebacks | 1,846 | 2,368 |
Accounts payable and other accrued liabilities | $ 50,927 | $ 58,117 |
Balance Sheet Account Detail 54
Balance Sheet Account Detail - Schedule of Amounts Presented in Accounts Payable and Other Accrued Liabilities (Detail) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2018 | Dec. 31, 2017 | |
Commercial/Medicaid Rebates and Government Chargebacks [Member] | ||
Accounts Payable and Other Liabilities [Roll Forward] | ||
Beginning balance | $ 10,358 | $ 9,817 |
Add: provisions | 13,805 | 106,647 |
(Less): credits or actual allowances | (14,604) | (106,106) |
Ending balance | 9,559 | 10,358 |
Distribution, Data, and GPO Administrative Fees [Member] | ||
Accounts Payable and Other Liabilities [Roll Forward] | ||
Beginning balance | 5,727 | 5,146 |
Add: provisions | 3,425 | 20,104 |
(Less): credits or actual allowances | (5,750) | (19,523) |
Ending balance | 3,402 | 5,727 |
Product Return Allowances [Member] | ||
Accounts Payable and Other Liabilities [Roll Forward] | ||
Beginning balance | 4,045 | 2,309 |
Add: provisions | 468 | 2,807 |
(Less): credits or actual allowances | 36 | (1,071) |
Ending balance | $ 4,549 | $ 4,045 |
Balance Sheet Account Detail 55
Balance Sheet Account Detail - Deferred Revenue (Details) - USD ($) $ in Thousands | Mar. 31, 2018 | Jan. 01, 2018 | Dec. 31, 2017 |
Deferred Revenue Arrangement [Line Items] | |||
Deferred revenue | $ 0 | $ 4,187 | |
Increase (decrease) in retained earnings due to revenue recognition | (495,691) | (502,107) | |
EVOMELA [Member] | |||
Deferred Revenue Arrangement [Line Items] | |||
Deferred revenue | 0 | 3,819 | |
ZEVALIN, in India Territory [Member] | |||
Deferred Revenue Arrangement [Line Items] | |||
Deferred revenue | 0 | $ 368 | |
Difference between Revenue Guidance in Effect before and after Topic 606 [Member] | Accounting Standards Update 2014-09 [Member] | |||
Deferred Revenue Arrangement [Line Items] | |||
Increase (decrease) in retained earnings due to revenue recognition | $ 3,894 | $ 4,700 |
Balance Sheet Account Detail 56
Balance Sheet Account Detail - Summary of Other Long-Term Liabilities (Detail) - USD ($) $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Accrued executive deferred compensation | $ 5,981 | $ 5,928 |
Deferred rent (non-current portion) | 20 | 52 |
Clinical study holdback fees, non-current | 62 | 59 |
Other tax liabilities | 176 | 176 |
Royalty liability | 300 | 0 |
Other long-term liabilities | $ 6,539 | $ 6,215 |
Gross-to-Net Product Sales - Re
Gross-to-Net Product Sales - Reconciliation of Gross-to-Net Product Sales (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Revenue, Net [Abstract] | ||
Gross product sales | $ 49,590 | $ 58,217 |
Commercial rebates and government chargebacks | (17,029) | (27,324) |
Data and distribution fees, GPO fees, and inventory management fees | (3,511) | (4,462) |
Prompt pay discounts | (390) | (270) |
Product returns allowance | (549) | (316) |
Product sales, net | $ 28,111 | $ 25,845 |
Composition of Total Revenue -
Composition of Total Revenue - Schedule of Product Sales, Net by Geography (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Segment Reporting Information [Line Items] | ||
Product sales, net | $ 28,111 | $ 25,845 |
United States [Member] | ||
Segment Reporting Information [Line Items] | ||
Product sales, net | 23,198 | 23,801 |
Total International [Member] | ||
Segment Reporting Information [Line Items] | ||
Product sales, net | 4,913 | 2,044 |
Total International [Member] | Europe [Member] | ||
Segment Reporting Information [Line Items] | ||
Product sales, net | 3,489 | 2,044 |
Total International [Member] | Asia Pacific [Member] | ||
Segment Reporting Information [Line Items] | ||
Product sales, net | $ 1,424 | $ 0 |
Sales Revenue, Net [Member] | Geographic Concentration Risk [Member] | ||
Segment Reporting Information [Line Items] | ||
Percentage of sales | 100.00% | 100.00% |
Sales Revenue, Net [Member] | Geographic Concentration Risk [Member] | United States [Member] | ||
Segment Reporting Information [Line Items] | ||
Percentage of sales | 82.50% | 92.10% |
Sales Revenue, Net [Member] | Geographic Concentration Risk [Member] | Total International [Member] | ||
Segment Reporting Information [Line Items] | ||
Percentage of sales | 17.50% | 7.90% |
Sales Revenue, Net [Member] | Geographic Concentration Risk [Member] | Total International [Member] | Europe [Member] | ||
Segment Reporting Information [Line Items] | ||
Percentage of sales | 12.40% | 7.90% |
Sales Revenue, Net [Member] | Geographic Concentration Risk [Member] | Total International [Member] | Asia Pacific [Member] | ||
Segment Reporting Information [Line Items] | ||
Percentage of sales | 5.10% | 0.00% |
Composition of Total Revenue 59
Composition of Total Revenue - Schedule of Product Sales, Net by Product Line (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Segment Reporting Information [Line Items] | ||
Product sales, net | $ 28,111 | $ 25,845 |
FOLOTYN [Member] | ||
Segment Reporting Information [Line Items] | ||
Product sales, net | 12,721 | 9,274 |
EVOMELA [Member] | ||
Segment Reporting Information [Line Items] | ||
Product sales, net | 8,134 | 6,301 |
BELEODAQ [Member] | ||
Segment Reporting Information [Line Items] | ||
Product sales, net | 2,713 | 2,871 |
ZEVALIN [Member] | ||
Segment Reporting Information [Line Items] | ||
Product sales, net | 3,025 | 2,845 |
MARQIBO [Member] | ||
Segment Reporting Information [Line Items] | ||
Product sales, net | 894 | 1,980 |
FUSILEV [Member] | ||
Segment Reporting Information [Line Items] | ||
Product sales, net | $ 624 | $ 2,574 |
Sales [Member] | ||
Segment Reporting Information [Line Items] | ||
Percentage of sales | 100.00% | 100.00% |
Sales [Member] | FOLOTYN [Member] | ||
Segment Reporting Information [Line Items] | ||
Percentage of sales | 45.30% | 35.90% |
Sales [Member] | EVOMELA [Member] | ||
Segment Reporting Information [Line Items] | ||
Percentage of sales | 28.90% | 24.40% |
Sales [Member] | BELEODAQ [Member] | ||
Segment Reporting Information [Line Items] | ||
Percentage of sales | 9.70% | 11.10% |
Sales [Member] | ZEVALIN [Member] | ||
Segment Reporting Information [Line Items] | ||
Percentage of sales | 10.80% | 11.00% |
Sales [Member] | MARQIBO [Member] | ||
Segment Reporting Information [Line Items] | ||
Percentage of sales | 3.20% | 7.70% |
Sales [Member] | FUSILEV [Member] | ||
Segment Reporting Information [Line Items] | ||
Percentage of sales | 2.20% | 10.00% |
Composition of Total Revenue 60
Composition of Total Revenue - By Product Line (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Concentration Risk [Line Items] | ||
License fees and service revenue | $ 2,384 | $ 3,256 |
Sales Revenue, Services, Net [Member] | ||
Concentration Risk [Line Items] | ||
Percentage of sales | 100.00% | 100.00% |
FOLOTYN in all Countries Except the U.S., Canada, Europe, and Turkey [Member] | ||
Concentration Risk [Line Items] | ||
License fees and service revenue | $ 377 | $ 263 |
FOLOTYN in all Countries Except the U.S., Canada, Europe, and Turkey [Member] | Sales Revenue, Services, Net [Member] | ||
Concentration Risk [Line Items] | ||
Percentage of sales | 15.80% | 8.10% |
ZEVALIN, in Asia and Certain Other Territories, Excluding China [Member] | ||
Concentration Risk [Line Items] | ||
License fees and service revenue | $ 2,001 | $ 615 |
ZEVALIN, in Asia and Certain Other Territories, Excluding China [Member] | Sales Revenue, Services, Net [Member] | ||
Concentration Risk [Line Items] | ||
Percentage of sales | 83.90% | 18.90% |
ZEVALIN, in India Territory [Member] | ||
Concentration Risk [Line Items] | ||
License fees and service revenue | $ 0 | $ 12 |
ZEVALIN, in India Territory [Member] | Sales Revenue, Services, Net [Member] | ||
Concentration Risk [Line Items] | ||
Percentage of sales | 0.00% | 0.40% |
ZEVALIN, FOLOTYN, BELEODAQ, MARQIBO, in Canada Territory | ||
Concentration Risk [Line Items] | ||
License fees and service revenue | $ 6 | $ 0 |
ZEVALIN, FOLOTYN, BELEODAQ, MARQIBO, in Canada Territory | Sales Revenue, Services, Net [Member] | ||
Concentration Risk [Line Items] | ||
Percentage of sales | 0.30% | 0.00% |
Sales and Marketing Contracted Services [Member] | ||
Concentration Risk [Line Items] | ||
License fees and service revenue | $ 0 | $ 2,366 |
Sales and Marketing Contracted Services [Member] | Sales Revenue, Services, Net [Member] | ||
Concentration Risk [Line Items] | ||
Percentage of sales | 0.00% | 72.70% |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock-Based Compensation Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total share-based compensation | $ 4,478 | $ 3,720 |
Cost of sales [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total share-based compensation | 66 | 30 |
Selling, general and administrative [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total share-based compensation | 3,691 | 3,238 |
Research and development [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total share-based compensation | $ 721 | $ 452 |
Net Loss Per Share - Computatio
Net Loss Per Share - Computation of Net Loss Per Share (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Earnings Per Share [Abstract] | ||
Net loss | $ (15,816) | $ (23,547) |
Weighted average shares - basic and diluted (shares) | 100,809,853 | 78,523,023 |
Net loss per share - basic and diluted ($ per share) | $ (0.16) | $ (0.30) |
Net Loss Per Share - Schedule o
Net Loss Per Share - Schedule of Securities Excluded from Calculation of Net Loss Per Share (Detail) - shares | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive excluded from computation of earnings per share amount (shares) | 11,816,280 | 14,053,382 |
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 (shares) | 3,854,959 | 10,454,799 |
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 (shares) | 5,589,852 | 1,557,920 |
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 (shares) | 1,875,569 | 1,769,530 |
Restricted Stock Units (RSUs) [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive excluded from computation of earnings per share amount (shares) | 210,214 | 217,206 |
Common Stock Warrant [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive excluded from computation of earnings per share amount (shares) | 261,622 | 0 |
Employee Stock Purchase Plan Shares [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive excluded from computation of earnings per share amount (shares) | 24,064 | 53,927 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Asset and Liability Fair Values (Detail) - USD ($) $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 |
Assets: | ||
Equity securities | $ 48,154 | $ 37,530 |
Deferred compensation investments (life insurance cash surrender value - Note 3(g)) | 11,463 | 14,887 |
Total Assets | 222,892 | 269,082 |
Liabilities: | ||
Deferred executive compensation liability (Note 15(f)) | 10,168 | 11,038 |
Drug development liability (Note 14) | 12,283 | 12,386 |
Talon CVR (Note 9(a)) | 6,501 | 6,210 |
Corixa Liability (Note 15(b)(i)) | 62 | 62 |
Total Liabilities | 29,014 | 29,696 |
Bank certificates of deposit [Member] | ||
Assets: | ||
Available-for-sale | 249 | 248 |
Money market funds [Member] | ||
Assets: | ||
Available-for-sale | 162,967 | 216,358 |
Mutual Funds [Member] | ||
Assets: | ||
Available-for-sale | 59 | 59 |
Level 1 [Member] | ||
Assets: | ||
Equity securities | 48,154 | 37,530 |
Deferred compensation investments (life insurance cash surrender value - Note 3(g)) | 0 | 0 |
Total Assets | 48,154 | 37,530 |
Liabilities: | ||
Deferred executive compensation liability (Note 15(f)) | 0 | 0 |
Drug development liability (Note 14) | 0 | 0 |
Talon CVR (Note 9(a)) | 0 | 0 |
Corixa Liability (Note 15(b)(i)) | 0 | 0 |
Total Liabilities | 0 | 0 |
Level 1 [Member] | Bank certificates of deposit [Member] | ||
Assets: | ||
Available-for-sale | 0 | 0 |
Level 1 [Member] | Money market funds [Member] | ||
Assets: | ||
Available-for-sale | 0 | 0 |
Level 1 [Member] | Mutual Funds [Member] | ||
Assets: | ||
Available-for-sale | 0 | 0 |
Level 2 [Member] | ||
Assets: | ||
Equity securities | 0 | 0 |
Deferred compensation investments (life insurance cash surrender value - Note 3(g)) | 11,463 | 14,887 |
Total Assets | 174,738 | 231,552 |
Liabilities: | ||
Deferred executive compensation liability (Note 15(f)) | 10,168 | 11,038 |
Drug development liability (Note 14) | 0 | 0 |
Talon CVR (Note 9(a)) | 0 | 0 |
Corixa Liability (Note 15(b)(i)) | 0 | 0 |
Total Liabilities | 10,168 | 11,038 |
Level 2 [Member] | Bank certificates of deposit [Member] | ||
Assets: | ||
Available-for-sale | 249 | 248 |
Level 2 [Member] | Money market funds [Member] | ||
Assets: | ||
Available-for-sale | 162,967 | 216,358 |
Level 2 [Member] | Mutual Funds [Member] | ||
Assets: | ||
Available-for-sale | 59 | 59 |
Level 3 [Member] | ||
Assets: | ||
Equity securities | 0 | 0 |
Deferred compensation investments (life insurance cash surrender value - Note 3(g)) | 0 | 0 |
Total Assets | 0 | 0 |
Liabilities: | ||
Deferred executive compensation liability (Note 15(f)) | 0 | 0 |
Drug development liability (Note 14) | 12,283 | 12,386 |
Talon CVR (Note 9(a)) | 6,501 | 6,210 |
Corixa Liability (Note 15(b)(i)) | 62 | 62 |
Total Liabilities | 18,846 | 18,658 |
Level 3 [Member] | Bank certificates of deposit [Member] | ||
Assets: | ||
Available-for-sale | 0 | 0 |
Level 3 [Member] | Money market funds [Member] | ||
Assets: | ||
Available-for-sale | 0 | 0 |
Level 3 [Member] | Mutual Funds [Member] | ||
Assets: | ||
Available-for-sale | $ 0 | $ 0 |
Fair Value Measurements - Fair
Fair Value Measurements - Fair Value Measurement Activity for Liabilities Utilize Level 3 Inputs (Detail) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2018 | Dec. 31, 2017 | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Beginning | $ 18,658 | $ 14,445 |
Ending | 18,846 | 18,658 |
Deferred development costs [Member] | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Transfers in (out) of Level 3 | (103) | (744) |
Talon CVR [Member] | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Transfers in (out) of Level 3 | $ 291 | $ 4,957 |
Business Combinations and Con66
Business Combinations and Contingent Consideration - Additional Information (Detail) - USD ($) $ / shares in Units, shares in Millions | Jul. 17, 2013 | Sep. 05, 2012 | Apr. 30, 2016 | Mar. 31, 2016 | Mar. 31, 2013 | Mar. 31, 2018 | Mar. 31, 2017 | Dec. 31, 2017 |
Business Acquisition [Line Items] | ||||||||
Milestone net sales achievement | $ 0 | |||||||
License fees received | $ 3,000,000 | |||||||
Historical Cost | $ 305,668,000 | $ 305,668,000 | ||||||
In-process research and development [Member] | ||||||||
Business Acquisition [Line Items] | ||||||||
Estimated cash flow period | 10 years | |||||||
Estimated cash flow discount rate | 25.00% | |||||||
Ligand Pharmaceuticals Inc [Member] | ||||||||
Business Acquisition [Line Items] | ||||||||
Milestone payments | $ 6,000,000 | $ 6,000,000 | ||||||
Melphalan In Process Research and Development [Member] | ||||||||
Business Acquisition [Line Items] | ||||||||
Historical Cost | $ 7,700,000 | $ 7,700,000 | $ 7,700,000 | |||||
Minimum [Member] | ||||||||
Business Acquisition [Line Items] | ||||||||
Royalties payout percentage on our future net sales of licensed products | 20.00% | |||||||
Milestone Payments [Member] | ||||||||
Business Acquisition [Line Items] | ||||||||
Milestone payments | $ 5,000,000 | $ 60,000,000 | ||||||
Milestone net sales achievement | 30,000,000 | |||||||
Ligand Contingent Consideration | $ 6,000,000 | |||||||
Milestone Payment One [Member] | ||||||||
Business Acquisition [Line Items] | ||||||||
Milestone payments | 10,000,000 | |||||||
Milestone net sales achievement | 60,000,000 | |||||||
Milestone Payment Two [Member] | ||||||||
Business Acquisition [Line Items] | ||||||||
Milestone payments | 25,000,000 | |||||||
Milestone net sales achievement | 100,000,000 | |||||||
Milestone Payment Three [Member] | ||||||||
Business Acquisition [Line Items] | ||||||||
Milestone payments | 50,000,000 | |||||||
Milestone net sales achievement | 200,000,000 | |||||||
Milestone Payment Four [Member] | ||||||||
Business Acquisition [Line Items] | ||||||||
Milestone payments | 100,000,000 | |||||||
Milestone net sales achievement | 400,000,000 | |||||||
Menadione Topical Lotion [Member] | ||||||||
Business Acquisition [Line Items] | ||||||||
Milestone payments | 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] | ||||||||
Cash consideration | $ 205,200,000 |
Business Combinations and Con67
Business Combinations and Contingent Consideration - Change in Fair Value of Contingent Consideration Related to Acquisitions (Detail) $ in Thousands | 3 Months Ended |
Mar. 31, 2018USD ($) | |
Change in Fair Value of Contingent Consideration [Roll Forward] | |
Beginning | $ 18,658 |
Ending | 18,846 |
Contingent Consideration [Member] | Talon Therapeutics, Inc. [Member] | |
Change in Fair Value of Contingent Consideration [Roll Forward] | |
Beginning | 6,210 |
Fair value adjustment | 291 |
Ending | $ 6,501 |
Business Combinations and Con68
Business Combinations and Contingent Consideration - Acquisition-Date Fair Value of Consideration Transferred (Detail) - Captisol-enabled, propylene glycol-free melphalan rights [Member] $ in Thousands | 1 Months Ended |
Mar. 31, 2013USD ($) | |
Business Acquisition [Line Items] | |
Cash consideration | $ 3,000 |
Ligand contingent consideration | 4,700 |
Total purchase consideration | $ 7,700 |
Business Combinations and Con69
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, Contingent Consideration [Line Items] | |
Total purchase consideration | $ 7,700 |
In-process research and development [Member] | |
Business Acquisition, Contingent Consideration [Line Items] | |
Total purchase consideration | $ 7,700 |
Out-License of Marqibo, Zeval70
Out-License of Marqibo, Zevalin, & Evolema in China Territory - Additional Information (Detail) $ in Thousands, shares in Millions | Sep. 17, 2014productagreementshares | Mar. 31, 2018USD ($)shares | Dec. 31, 2017USD ($)shares | Dec. 31, 2016shares | Dec. 31, 2015USD ($) |
Other Commitments [Line Items] | |||||
Equity securities | $ 48,154 | $ 37,530 | |||
CASI Out-License [Member] | |||||
Other Commitments [Line Items] | |||||
Number of agreements | agreement | 3 | ||||
Number of products | product | 3 | ||||
Shares received (shares) | shares | 5.4 | 1.5 | 4.6 | ||
Number of shares held in investment (shares) | shares | 11.5 | ||||
Percentage of ownership | 14.50% | ||||
Undiscounted proceeds | $ 9,700 | ||||
Equity securities | $ 48,200 |
Out-License of Marqibo, Zeval71
Out-License of Marqibo, Zevalin, & Evolema 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, 2017 | Dec. 31, 2016 |
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 | 1.5 | 4.6 |
Share price ($ 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 |
Out-License Of Zevalin In Cer72
Out-License Of Zevalin In Certain Ex-U.S. Territories (Details) - USD ($) | Jun. 30, 2017 | Apr. 30, 2018 | Jan. 31, 2016 | Dec. 31, 2015 | Jan. 31, 2016 | Mar. 31, 2018 | Mar. 31, 2017 | Dec. 31, 2015 |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||
Milestone net sales achievement | $ 0 | |||||||
Zevalin Rights [Member] | ||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||
Milestone net sales achievement | $ 2,000,000 | |||||||
Zevalin Rights [Member] | Total Consideration [Member] | ||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||
Total consideration received | $ 18,000,000 | |||||||
Milestone net sales achievement | $ 15,000,000 | |||||||
Zevalin Rights [Member] | Payment One [Member] | ||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||
Total consideration received | $ 15,000,000 | |||||||
Zevalin Rights [Member] | Payment Two [Member] | ||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||
Total consideration received | $ 3,000,000 | |||||||
Milestone net sales achievement | $ 3,000,000 | |||||||
Subsequent Event [Member] | Zevalin Rights [Member] | ||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||
Milestone net sales achievement | $ 2,000,000 |
Co-Promotion Arrangement With73
Co-Promotion Arrangement With Eagle Pharmaceuticals (Details) | Nov. 04, 2015USD ($)product | Mar. 31, 2018USD ($) | Mar. 31, 2017USD ($) |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Term of contract | 18 months | ||
License fees and service revenue | $ 2,384,000 | $ 3,256,000 | |
Milestone net sales achievement | 0 | ||
Collaborative Arrangement, Co-promotion [Member] | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Number of products | product | 6 | ||
Fixed payment | $ 12,800,000 | ||
License fees and service revenue | 2,400,000 | ||
Milestone net sales achievement | $ 0 | ||
Reimbursable expense | $ 2,100,000 |
Convertible Senior Notes - Addi
Convertible Senior Notes - Additional Information (Detail) | Dec. 23, 2013USD ($) | Dec. 17, 2013USD ($)note | Oct. 31, 2017USD ($)shares | Jul. 31, 2017shares | Dec. 31, 2016USD ($)open_market_purchaseshares | Dec. 31, 2013USD ($)$ / shares | Mar. 31, 2018USD ($)day$ / sharesshares | Dec. 31, 2017USD ($)shares | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($)shares |
Debt Disclosure [Line Items] | ||||||||||
Stock issued during period, shares, new issues (shares) | shares | 3,243,882 | 10,314,250 | 10,890,915 | |||||||
Common shares sold (shares) | $ 103,000 | $ 100,000 | $ 100,000 | |||||||
2018 Convertible Notes [Member] | ||||||||||
Debt Disclosure [Line Items] | ||||||||||
Principal | 40,565,000 | 40,565,000 | 40,565,000 | |||||||
Fair value | $ 63,800,000 | 74,300,000 | 74,300,000 | |||||||
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% | 2.75% | ||||||||
Number of notes if converted | note | 120,000 | |||||||||
Debt instrument face value | $ 110,000,000 | $ 40,600,000 | $ 40,600,000 | 40,600,000 | $ 110,000,000 | |||||
Conversion rate, shares (shares) | shares | 95 | |||||||||
Conversion rate, price per share ($ per share) | $ / shares | $ 1,000 | |||||||||
Common shares converted value (shares) | $ 11,400,000 | $ 3,900,000 | ||||||||
Money conversion price per share ($ per share) | $ / shares | $ 10.53 | |||||||||
Net proceeds from convertible notes | $ 115,400,000 | |||||||||
Professional fee | 4,600,000 | |||||||||
Additional paid-in capital | $ (13,100,000) | |||||||||
Number of open market purchases | open_market_purchase | 2 | |||||||||
Number of instruments (shares) | shares | 69,472 | 9,963 | ||||||||
Repurchase of principal | $ 69,500,000 | $ 10,000,000 | ||||||||
Repayments | $ 27,300,000 | $ 9,000,000 | ||||||||
Gain (loss) on retirement | (800,000) | (25,000) | ||||||||
Proceeds from unwinding | $ 5,800,000 | $ 21,000 | ||||||||
Stock issued during period, shares, new issues (shares) | shares | 5,400,000 | |||||||||
Stock issued, value | $ 73,000,000 | |||||||||
Strike price per share ($ per share) | $ / shares | $ 14.03 | |||||||||
Common shares sold (shares) | $ 11,400,000 | |||||||||
Percentage of product of last reported sale price of common stock | 98.00% | |||||||||
Convertible senior notes trading price | $ 1,000 | |||||||||
Threshold percentage of conversion price | 130.00% | |||||||||
Convertible senior notes conversion description | 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 Notes' 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 $1,000 principal amount of 2018 Convertible Notes for such trading day was less than 98% of the product of (i) the last reported sale price of our common stock on such trading day and (ii) the applicable conversion rate on such trading day; (3) upon the occurrence of certain corporate transactions; and (4) at any time prior to our stockholders’ approval to settle the 2018 Convertible Notes in our common shares and/or cash. | |||||||||
2.75% Convertible Senior Notes Due 2018 [Member] | Minimum [Member] | ||||||||||
Debt Disclosure [Line Items] | ||||||||||
Debt convertible trading days | 20 days | |||||||||
Debt convertible consecutive trading days | day | 5 | |||||||||
2.75% Convertible Senior Notes Due 2018 [Member] | Maximum [Member] | ||||||||||
Debt Disclosure [Line Items] | ||||||||||
Debt convertible consecutive trading days | day | 30 |
Convertible Senior Notes - Carr
Convertible Senior Notes - Carrying Value of 2018 Convertible Notes (Detail) - 2018 Convertible Notes [Member] - USD ($) $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 |
Debt Instrument [Line Items] | ||
Principal amount | $ 40,565 | $ 40,565 |
(Less): Unamortized debt discount (amortized through December 2018) | (1,568) | (2,101) |
(Less): Debt issuance costs | (178) | (240) |
Carrying value | $ 38,819 | $ 38,224 |
Convertible Senior Notes - Comp
Convertible Senior Notes - Components of the Interest Expense Recognized (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Debt Disclosure [Abstract] | ||
Contractual coupon interest expense | $ 279 | $ 757 |
Amortization of debt issuance costs | 61 | 166 |
Accretion of debt discount | 533 | 1,381 |
Total | $ 873 | $ 2,304 |
Effective interest rate | 8.41% | 8.65% |
FOLOTYN License Agreement And77
FOLOTYN License Agreement And Development Liability - Additional Information (Detail) - USD ($) $ in Thousands | May 29, 2013 | Mar. 31, 2018 | Mar. 31, 2017 |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Total operating costs and expenses | $ 55,759 | $ 51,010 | |
Mundipharma [Member] | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Total operating costs and expenses | $ 7,000 | ||
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 |
FOLOTYN License Agreement And78
FOLOTYN License Agreement And Development Liability - Schedule of Drug Development Liability Adjustments (Detail) $ in Thousands | 3 Months Ended |
Mar. 31, 2018USD ($) | |
Accrued Drug Development Expenses [Roll Forward] | |
Balance as of December 31, 2017 | $ 275 |
Balance as of March 31, 2018 | 275 |
FOLOTYN [Member] | |
Accrued Drug Development Expenses [Roll Forward] | |
Balance as of December 31, 2017 | 12,386 |
Transfer from long-term to current in 2018 | 0 |
(Less): Expenses incurred in 2018 | (103) |
Balance as of March 31, 2018 | 12,283 |
FOLOTYN [Member] | Drug Development Liability Current [Member] | |
Accrued Drug Development Expenses [Roll Forward] | |
Balance as of December 31, 2017 | 275 |
Transfer from long-term to current in 2018 | 103 |
(Less): Expenses incurred in 2018 | (103) |
Balance as of March 31, 2018 | 275 |
FOLOTYN [Member] | Drug Development Liability Long Term [Member] | |
Accrued Drug Development Expenses [Roll Forward] | |
Balance as of December 31, 2017 | 12,111 |
Transfer from long-term to current in 2018 | (103) |
(Less): Expenses incurred in 2018 | 0 |
Balance as of March 31, 2018 | $ 12,008 |
Financial Commitments & Conti79
Financial Commitments & Contingencies And License Agreements - Additional Information (Detail) € in Millions | Jun. 30, 2017USD ($) | Apr. 30, 2018USD ($) | Sep. 30, 2017USD ($) | Jul. 31, 2017USD ($)shares | Apr. 30, 2016USD ($)shares | Mar. 31, 2016USD ($) | Feb. 29, 2016 | Jan. 31, 2016USD ($) | Dec. 31, 2015USD ($) | Feb. 28, 2015USD ($) | Jun. 30, 2014 | Feb. 28, 2014USD ($) | Apr. 30, 2012EUR (€) | Feb. 28, 2010USD ($) | Nov. 30, 2009USD ($) | Oct. 31, 2008USD ($)shares | Jan. 31, 2016USD ($) | Mar. 31, 2018USD ($)Country | Mar. 31, 2017USD ($) | Mar. 31, 2016USD ($) | Dec. 31, 2015USD ($) | Mar. 31, 2014USD ($) | Dec. 31, 2017USD ($)shares | Dec. 31, 2016USD ($)shares | Aug. 31, 2017USD ($) | Nov. 30, 2014USD ($) | Jul. 17, 2013USD ($) | May 31, 2006USD ($) |
Long-term Purchase Commitment [Line Items] | ||||||||||||||||||||||||||||
Potential payments based on achievement of sales milestones | $ 325,000,000 | |||||||||||||||||||||||||||
Acquisition-related contingent obligations | 6,563,000 | $ 6,272,000 | ||||||||||||||||||||||||||
Milestone net sales achievement | $ 0 | |||||||||||||||||||||||||||
Payment of all royalty fees | $ 2,600,000 | |||||||||||||||||||||||||||
Amount receivable on approval of oral form of FUSILEV | $ 200,000 | |||||||||||||||||||||||||||
Intangible assets | 305,668,000 | $ 305,668,000 | ||||||||||||||||||||||||||
Additional license fees | 60,000,000 | |||||||||||||||||||||||||||
Common stock issued (shares) | shares | 3,243,882 | 10,314,250 | 10,890,915 | |||||||||||||||||||||||||
Consideration paid for the rights granted (shares) | $ 1,000,000 | |||||||||||||||||||||||||||
Proceeds from common shares sold under an at-market-issuance sales agreement | $ 23,745,000 | $ 104,527,000 | $ 73,869,000 | |||||||||||||||||||||||||
Cash paid for income taxes | 0 | $ 0 | ||||||||||||||||||||||||||
Deferrals and contributions | $ 10,200,000 | 11,000,000 | ||||||||||||||||||||||||||
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% | |||||||||||||||||||||||||||
EVOMELA distribution rights [Member] | ||||||||||||||||||||||||||||
Long-term Purchase Commitment [Line Items] | ||||||||||||||||||||||||||||
Intangible assets | $ 7,700,000 | $ 7,700,000 | 7,700,000 | |||||||||||||||||||||||||
Zevalin Rights [Member] | ||||||||||||||||||||||||||||
Long-term Purchase Commitment [Line Items] | ||||||||||||||||||||||||||||
Milestone net sales achievement | 2,000,000 | |||||||||||||||||||||||||||
ZEVALIN, FOLOTYN, BELEODAQ, And MARQIBO [Member] | ||||||||||||||||||||||||||||
Long-term Purchase Commitment [Line Items] | ||||||||||||||||||||||||||||
Payments receivable on achievement of potential regulatory milestones | 2,000,000 | |||||||||||||||||||||||||||
Total consideration received | $ 6,000,000 | |||||||||||||||||||||||||||
Regulatory [Member] | ||||||||||||||||||||||||||||
Long-term Purchase Commitment [Line Items] | ||||||||||||||||||||||||||||
Receivable for contracted sales and marketing services | $ 2,000,000 | |||||||||||||||||||||||||||
Total Consideration [Member] | Zevalin Rights [Member] | ||||||||||||||||||||||||||||
Long-term Purchase Commitment [Line Items] | ||||||||||||||||||||||||||||
Total consideration received | $ 18,000,000 | |||||||||||||||||||||||||||
Milestone net sales achievement | $ 15,000,000 | |||||||||||||||||||||||||||
Payment One [Member] | Zevalin Rights [Member] | ||||||||||||||||||||||||||||
Long-term Purchase Commitment [Line Items] | ||||||||||||||||||||||||||||
Total consideration received | $ 15,000,000 | |||||||||||||||||||||||||||
Payment Two [Member] | Zevalin Rights [Member] | ||||||||||||||||||||||||||||
Long-term Purchase Commitment [Line Items] | ||||||||||||||||||||||||||||
Total consideration received | $ 3,000,000 | |||||||||||||||||||||||||||
Milestone net sales achievement | $ 3,000,000 | |||||||||||||||||||||||||||
Ligand Pharmaceuticals Inc [Member] | ||||||||||||||||||||||||||||
Long-term Purchase Commitment [Line Items] | ||||||||||||||||||||||||||||
Milestone payments | 6,000,000 | $ 6,000,000 | ||||||||||||||||||||||||||
ZEVALIN [Member] | ||||||||||||||||||||||||||||
Long-term Purchase Commitment [Line Items] | ||||||||||||||||||||||||||||
Potential payments based on achievement of sales milestones | 5,000,000 | |||||||||||||||||||||||||||
Acquisition-related contingent obligations | $ 100,000 | 100,000 | ||||||||||||||||||||||||||
ZEVALIN [Member] | Licensing Agreements [Member] | ||||||||||||||||||||||||||||
Long-term Purchase Commitment [Line Items] | ||||||||||||||||||||||||||||
Fees paid to Bayer for acquiring licensing rights | € | € 19 | |||||||||||||||||||||||||||
Minimum number of countries outside U.S. approved ZEVALIN for treatment | Country | 40 | |||||||||||||||||||||||||||
Percentage of royalty | 20.00% | |||||||||||||||||||||||||||
License agreement contractual terms | 15 years | |||||||||||||||||||||||||||
Payments receivable on achievement of potential sales milestones | $ 1,500,000 | |||||||||||||||||||||||||||
Payments receivable on achievement of potential regulatory milestones | 1,500,000 | |||||||||||||||||||||||||||
Aggregate amount receivable based on achievement of milestones | 3,000,000 | |||||||||||||||||||||||||||
Talon Therapeutics, Inc. [Member] | ||||||||||||||||||||||||||||
Long-term Purchase Commitment [Line Items] | ||||||||||||||||||||||||||||
Acquisition-related contingent obligations | 6,500,000 | $ 6,200,000 | ||||||||||||||||||||||||||
Contingent value rights future cash payments | 195,000,000 | $ 195,000,000 | ||||||||||||||||||||||||||
SPI-2012 [Member] | ||||||||||||||||||||||||||||
Long-term Purchase Commitment [Line Items] | ||||||||||||||||||||||||||||
Milestone payments | $ 2,700,000 | |||||||||||||||||||||||||||
Issuance (shares) | shares | 318,750 | |||||||||||||||||||||||||||
Proceeds from common shares sold under an at-market-issuance sales agreement | $ 2,300,000 | |||||||||||||||||||||||||||
Cash paid for income taxes | $ 400,000 | |||||||||||||||||||||||||||
Spi Two Thousand Twelve [Member] | ||||||||||||||||||||||||||||
Long-term Purchase Commitment [Line Items] | ||||||||||||||||||||||||||||
Potential payments based on achievement of sales milestones | 225,000,000 | |||||||||||||||||||||||||||
Potential payments based on achievement of regulatory milestones | 13,000,000 | |||||||||||||||||||||||||||
Poziotinib [Member] | Licensing Agreements [Member] | ||||||||||||||||||||||||||||
Long-term Purchase Commitment [Line Items] | ||||||||||||||||||||||||||||
Potential payments based on achievement of regulatory milestones | $ 33,000,000 | |||||||||||||||||||||||||||
Minimum [Member] | ||||||||||||||||||||||||||||
Long-term Purchase Commitment [Line Items] | ||||||||||||||||||||||||||||
Percentage of royalty on annual worldwide sales under condition one | 20.00% | |||||||||||||||||||||||||||
Percentage of royalties on net sale of licensed products | 20.00% | |||||||||||||||||||||||||||
Minimum [Member] | FOLOTYN [Member] | ||||||||||||||||||||||||||||
Long-term Purchase Commitment [Line Items] | ||||||||||||||||||||||||||||
Amount of annual worldwide sales on which royalty is payable under condition two | $ 150,000,000 | |||||||||||||||||||||||||||
Amount of annual worldwide sales on which royalty is payable under condition three | 300,000,000 | |||||||||||||||||||||||||||
Maximum [Member] | FOLOTYN [Member] | ||||||||||||||||||||||||||||
Long-term Purchase Commitment [Line Items] | ||||||||||||||||||||||||||||
Amount of annual worldwide sales on which royalty is payable under condition one | 150,000,000 | |||||||||||||||||||||||||||
Amount of annual worldwide sales on which royalty is payable under condition two | 300,000,000 | |||||||||||||||||||||||||||
Maximum [Member] | Regulatory [Member] | ||||||||||||||||||||||||||||
Long-term Purchase Commitment [Line Items] | ||||||||||||||||||||||||||||
Milestone net sales achievement | 3,000,000 | |||||||||||||||||||||||||||
Potential milestone payments | 16,000,000 | |||||||||||||||||||||||||||
Maximum [Member] | Commercial progress and sales-dependent [Member] | ||||||||||||||||||||||||||||
Long-term Purchase Commitment [Line Items] | ||||||||||||||||||||||||||||
Potential milestone payments | $ 107,000,000 | |||||||||||||||||||||||||||
INDIA [Member] | ZEVALIN [Member] | Licensing Agreements [Member] | ||||||||||||||||||||||||||||
Long-term Purchase Commitment [Line Items] | ||||||||||||||||||||||||||||
Percentage of royalty | 20.00% | |||||||||||||||||||||||||||
License agreement contractual terms | 15 years | |||||||||||||||||||||||||||
Up-front non-refundable payment | $ 500,000 | |||||||||||||||||||||||||||
Allergan [Member] | ||||||||||||||||||||||||||||
Long-term Purchase Commitment [Line Items] | ||||||||||||||||||||||||||||
Up-front non-refundable payment | $ 41,500,000 | |||||||||||||||||||||||||||
License fee | $ 300,000 | |||||||||||||||||||||||||||
Allergan [Member] | Common Class A | ||||||||||||||||||||||||||||
Long-term Purchase Commitment [Line Items] | ||||||||||||||||||||||||||||
Common stock issued (shares) | shares | 25,000 | |||||||||||||||||||||||||||
Stock issued, value | $ 100,000 | |||||||||||||||||||||||||||
Nippon Kayaku [Member] | ||||||||||||||||||||||||||||
Long-term Purchase Commitment [Line Items] | ||||||||||||||||||||||||||||
Payments receivable on achievement of potential regulatory milestones | $ 10,000,000 | |||||||||||||||||||||||||||
Upfront fee | $ 15,000,000 | |||||||||||||||||||||||||||
Payment on achievement of commercialization milestones | 126,000,000 | |||||||||||||||||||||||||||
TopoTarget [Member] | ||||||||||||||||||||||||||||
Long-term Purchase Commitment [Line Items] | ||||||||||||||||||||||||||||
Payments receivable on achievement of potential sales milestones | 190,000,000 | |||||||||||||||||||||||||||
Payments receivable on achievement of potential regulatory milestones | $ 88,000,000 | |||||||||||||||||||||||||||
Payment of all royalty fees | $ 30,000,000 | |||||||||||||||||||||||||||
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 | $ 10,000,000 | |||||||||||||||||||||||||||
Aggregate payout value | $ 17,800,000 | |||||||||||||||||||||||||||
Second milestone payment | $ 25,000,000 | |||||||||||||||||||||||||||
Subsequent Event [Member] | Zevalin Rights [Member] | ||||||||||||||||||||||||||||
Long-term Purchase Commitment [Line Items] | ||||||||||||||||||||||||||||
Milestone net sales achievement | $ 2,000,000 | |||||||||||||||||||||||||||
Restatement Adjustment [Member] | EVOMELA distribution rights [Member] | ||||||||||||||||||||||||||||
Long-term Purchase Commitment [Line Items] | ||||||||||||||||||||||||||||
Intangible assets | $ (7,700,000) | $ (7,700,000) |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |||
Provision (benefit) for income taxes | $ 3 | $ (201) | |
Tax on currency transactions | $ 1,000 | ||
Provisional decrease in deferred tax assets | $ 38,900 | ||
Provisional decrease in valuation allowance | 41,400 | ||
Income tax benefit due to reduction in tax rate | 2,500 | ||
Valuation Allowance, Operating Loss Carryforwards [Member] | |||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Increase (decrease) in valuation allowance due to deferred tax assets | $ (2,900) |
Stockholders' Equity- Additiona
Stockholders' Equity- Additional Information (Detail) - USD ($) | 1 Months Ended | 5 Months Ended | 12 Months Ended | |||
Aug. 31, 2017 | Jul. 31, 2017 | Dec. 31, 2015 | Dec. 31, 2017 | Dec. 31, 2016 | Mar. 31, 2018 | |
Equity [Abstract] | ||||||
Maximum proceeds | $ 150,000,000 | $ 100,000,000 | ||||
Authorized value of common stock remaining for sale under agreement | $ 43,900,000 | |||||
Common stock issued (shares) | 3,243,882 | 10,314,250 | 10,890,915 | |||
Proceeds Received (Net of Broker Commissions and Fees ) | $ 23,745,000 | $ 104,527,000 | $ 73,869,000 |
Immaterial Restatement Of Pri82
Immaterial Restatement Of Prior Period Financial Statements For Stock-Based Compensation - Summary of Revisions to the Consolidated Statements of Operations (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Operating costs and expenses: | ||
Selling, general and administrative | $ 24,104 | $ 19,104 |
Research and development | 17,895 | 14,779 |
Total operating costs and expenses | 55,759 | 51,010 |
Loss from operations | (25,264) | (21,909) |
Loss before income taxes | (15,813) | (23,748) |
Net loss | $ (15,816) | $ (23,547) |
Net loss per share: | ||
Basic ($ per share) | $ (0.30) | |
Diluted ($ per share) | $ (0.30) | |
Scenario, Previously Reported [Member] | ||
Operating costs and expenses: | ||
Selling, general and administrative | $ 18,607 | |
Research and development | 14,696 | |
Total operating costs and expenses | 50,430 | |
Loss from operations | (21,329) | |
Loss before income taxes | (23,168) | |
Net loss | $ (22,967) | |
Net loss per share: | ||
Basic ($ per share) | $ (0.29) | |
Diluted ($ per share) | $ (0.29) |
Immaterial Restatement Of Pri83
Immaterial Restatement Of Prior Period Financial Statements For Stock-Based Compensation - Summary of Revisions to the Consolidated Statements of Comprehensive Loss (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||
Net loss | $ (15,816) | $ (23,547) |
Total comprehensive loss | (21,588) | |
Scenario, Previously Reported [Member] | ||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||
Net loss | (22,967) | |
Total comprehensive loss | $ (21,008) |
Implementation of New Revenue84
Implementation of New Revenue Recognition Standard on January 1, 2018 - Additional Information (Details) - USD ($) $ in Thousands | Mar. 31, 2018 | Jan. 01, 2018 | Dec. 31, 2017 |
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||
Increase (decrease) in retained earnings due to revenue recognition | $ (495,691) | $ (502,107) | |
Difference between Revenue Guidance in Effect before and after Topic 606 [Member] | Accounting Standards Update 2014-09 [Member] | |||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||
Increase (decrease) in retained earnings due to revenue recognition | $ 3,894 | $ 4,700 |
Implementation of New Revenue85
Implementation of New Revenue Recognition Standard on January 1, 2018 - Condensed Consolidated Statement of Operations (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Revenue: | ||
Product sales, net | $ 28,111 | $ 25,845 |
License fees and service revenue | 2,384 | 3,256 |
Total revenues | 30,495 | 29,101 |
Loss from operations | (25,264) | (21,909) |
Loss before income taxes | (15,813) | (23,748) |
Net loss | $ (15,816) | $ (23,547) |
Net loss per share: | ||
Basic and diluted ($ per share) | $ (0.16) | $ (0.30) |
Difference between Revenue Guidance in Effect before and after Topic 606 [Member] | Accounting Standards Update 2014-09 [Member] | ||
Revenue: | ||
Product sales, net | $ 397 | |
License fees and service revenue | 120 | |
Total revenues | 517 | |
Loss from operations | 517 | |
Loss before income taxes | 517 | |
Net loss | $ 517 | |
Net loss per share: | ||
Basic and diluted ($ per share) | $ 0.01 | |
Calculated under Revenue Guidance in Effect before Topic 606 [Member] | ||
Revenue: | ||
Product sales, net | $ 28,508 | |
License fees and service revenue | 2,504 | |
Total revenues | 31,012 | |
Loss from operations | (24,747) | |
Loss before income taxes | (15,296) | |
Net loss | $ (15,299) | |
Net loss per share: | ||
Basic and diluted ($ per share) | $ (0.15) |
Implementation of New Revenue86
Implementation of New Revenue Recognition Standard on January 1, 2018 - Condensed Consolidated Balance Sheet (Details) - USD ($) $ in Thousands | Mar. 31, 2018 | Jan. 01, 2018 | Dec. 31, 2017 |
Current assets: | |||
Accounts receivable, net of allowance for doubtful accounts of $71 and $71, respectively | $ 33,375 | $ 32,260 | |
Total current assets | 277,028 | 277,746 | |
Total assets | 444,273 | 487,439 | |
Current liabilities: | |||
Deferred revenue | 0 | 3,872 | |
Total current liabilities | 93,422 | 109,749 | |
Deferred revenue, less current portion | 0 | 315 | |
Total liabilities | 119,979 | 136,100 | |
Stockholders’ equity: | |||
Accumulated deficit | (495,691) | (502,107) | |
Total stockholders’ equity | 324,294 | 351,339 | |
Total liabilities and stockholders’ equity | 444,273 | $ 487,439 | |
Difference between Revenue Guidance in Effect before and after Topic 606 [Member] | Accounting Standards Update 2014-09 [Member] | |||
Current assets: | |||
Accounts receivable, net of allowance for doubtful accounts of $71 and $71, respectively | 107 | ||
Total current assets | 107 | ||
Total assets | 107 | ||
Current liabilities: | |||
Deferred revenue | 3,476 | ||
Total current liabilities | 3,476 | ||
Deferred revenue, less current portion | 311 | ||
Total liabilities | 3,787 | ||
Stockholders’ equity: | |||
Accumulated deficit | 3,894 | $ 4,700 | |
Total stockholders’ equity | 3,894 | ||
Total liabilities and stockholders’ equity | 107 | ||
Calculated under Revenue Guidance in Effect before Topic 606 [Member] | |||
Current assets: | |||
Accounts receivable, net of allowance for doubtful accounts of $71 and $71, respectively | 33,482 | ||
Total current assets | 277,135 | ||
Total assets | 444,380 | ||
Current liabilities: | |||
Deferred revenue | 3,476 | ||
Total current liabilities | 96,898 | ||
Deferred revenue, less current portion | 311 | ||
Total liabilities | 123,766 | ||
Stockholders’ equity: | |||
Accumulated deficit | (491,797) | ||
Total stockholders’ equity | 328,188 | ||
Total liabilities and stockholders’ equity | $ 444,380 |
Implementation of New Revenue87
Implementation of New Revenue Recognition Standard on January 1, 2018 - Condensed Consolidated Cash Flows (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||
Net loss | $ (15,816) | $ (23,547) |
Changes in operating assets and liabilities: | ||
Accounts receivable, net | (583) | 310 |
Deferred revenue | 0 | $ (296) |
Difference between Revenue Guidance in Effect before and after Topic 606 [Member] | Accounting Standards Update 2014-09 [Member] | ||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||
Net loss | 517 | |
Changes in operating assets and liabilities: | ||
Accounts receivable, net | (107) | |
Deferred revenue | (410) | |
Calculated under Revenue Guidance in Effect before Topic 606 [Member] | ||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||
Net loss | (15,299) | |
Changes in operating assets and liabilities: | ||
Accounts receivable, net | (690) | |
Deferred revenue | $ (410) |