Document_and_Entity_Informatio
Document and Entity Information | 6 Months Ended | |
Jun. 30, 2014 | Jul. 31, 2014 | |
Document And Entity Information [Abstract] | ' | ' |
Document Type | '10-Q | ' |
Amendment Flag | 'false | ' |
Document Period End Date | 30-Jun-14 | ' |
Document Fiscal Year Focus | '2014 | ' |
Document Fiscal Period Focus | 'Q2 | ' |
Trading Symbol | 'SPPI | ' |
Entity Registrant Name | 'SPECTRUM PHARMACEUTICALS INC | ' |
Entity Central Index Key | '0000831547 | ' |
Current Fiscal Year End Date | '--12-31 | ' |
Entity Filer Category | 'Accelerated Filer | ' |
Entity Common Stock, Shares Outstanding | ' | 65,731,956 |
Condensed_Consolidated_Balance
Condensed Consolidated Balance Sheets (USD $) | Jun. 30, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Current assets: | ' | ' |
Cash and cash equivalents | $132,405 | $156,306 |
Marketable securities | 3,306 | 3,471 |
Accounts receivable, net of allowance for doubtful accounts of $177 and $206, respectively | 56,742 | 49,483 |
Other receivables | 11,802 | 7,539 |
Inventories | 10,881 | 13,519 |
Prepaid expenses and other current assets | 3,410 | 3,213 |
Deferred tax assets | 1,587 | 1,659 |
Total current assets | 220,133 | 235,190 |
Property and equipment, net of accumulated depreciation | 1,407 | 1,535 |
Intangible assets, net of accumulated amortization | 219,735 | 231,352 |
Goodwill | 18,476 | 18,501 |
Other assets | 15,197 | 12,577 |
Total assets | 474,948 | 499,155 |
Current liabilities: | ' | ' |
Accounts payable and other accrued liabilities | 69,178 | 79,837 |
Accrued payroll and benefits | 5,149 | 6,872 |
Deferred revenue | 33 | 156 |
Drug development liability | 3,119 | 3,119 |
Total current liabilities | 77,479 | 89,984 |
Drug development liability, less current portion | 14,069 | 14,623 |
Acquisition-related contingent obligations | 10,058 | 8,329 |
Deferred tax liability | 8,167 | 7,168 |
Other long-term liabilities | 5,709 | 5,965 |
Convertible senior notes | 93,812 | 91,480 |
Total liabilities | 209,294 | 217,549 |
Commitments and contingencies | ' | ' |
Stockholders' equity: | ' | ' |
Preferred stock | 0 | 0 |
Common stock, $0.001 par value; 175,000,000 shares authorized; 65,730,897 and 64,104,173 shares issued and outstanding at June 30, 2014 and December 31, 2013, respectively | 66 | 64 |
Additional paid-in capital | 532,554 | 518,144 |
Accumulated other comprehensive income | 1,734 | 894 |
Accumulated deficit | -268,823 | -237,619 |
Total stockholders' equity | 265,654 | 281,606 |
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | 474,948 | 499,155 |
Series B junior participating preferred stock [Member] | ' | ' |
Stockholders' equity: | ' | ' |
Preferred stock | 0 | 0 |
Series E Convertible Voting Preferred Stock [Member] | ' | ' |
Stockholders' equity: | ' | ' |
Preferred stock | $123 | $123 |
Condensed_Consolidated_Balance1
Condensed Consolidated Balance Sheets (Parenthetical) (USD $) | Jun. 30, 2014 | Dec. 31, 2013 |
In Thousands, except Share data, unless otherwise specified | ||
Allowance for doubtful accounts receivable | $177 | $206 |
Preferred stock, par value | $0.00 | $0.00 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Common stock, par value | $0.00 | $0.00 |
Common stock, shares authorized | 175,000,000 | 175,000,000 |
Common stock, shares issued | 65,730,897 | 64,104,173 |
Common stock, shares outstanding | 65,730,897 | 64,104,173 |
Series B junior participating preferred stock [Member] | ' | ' |
Preferred stock, par value | $0.00 | $0.00 |
Preferred stock, shares authorized | 1,500,000 | 1,500,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Series E Convertible Voting Preferred Stock [Member] | ' | ' |
Preferred stock, par value | $0.00 | $0.00 |
Preferred stock, stated value | $10,000 | $10,000 |
Preferred stock, shares authorized | 2,000 | 2,000 |
Preferred stock, shares issued | 20 | 20 |
Preferred stock, shares outstanding | 20 | 20 |
Convertible preferred shares | 40,000 | 40,000 |
Preferred stock, liquidation value | $240 | $240 |
Condensed_Consolidated_Stateme
Condensed Consolidated Statements of Operations (USD $) | 3 Months Ended | 6 Months Ended | ||
In Thousands, except Share data, unless otherwise specified | Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 |
Revenues: | ' | ' | ' | ' |
Product sales, net | $46,855 | $32,213 | $86,951 | $61,559 |
License fees and service revenue | ' | 1,019 | 28 | 10,340 |
Total revenues | 46,855 | 33,232 | 86,979 | 71,899 |
Operating costs and expenses: | ' | ' | ' | ' |
Cost of product sales (excludes amortization and impairment of intangible assets) | 6,156 | 7,268 | 12,434 | 14,050 |
Selling, general and administrative | 25,399 | 22,584 | 48,802 | 44,598 |
Research and development | 11,335 | 10,460 | 40,832 | 22,343 |
Amortization and impairment of intangible assets | 5,361 | 5,449 | 10,721 | 9,894 |
Total operating costs and expenses | 48,251 | 45,761 | 112,789 | 90,885 |
Loss from operations | -1,396 | -12,529 | -25,810 | -18,986 |
Other expenses: | ' | ' | ' | ' |
Interest expense, net | -1,976 | -397 | -4,043 | -818 |
Change in fair value of contingent consideration related to acquisitions | -1,005 | ' | -1,729 | ' |
Other income (expense), net | -487 | 234 | -845 | -663 |
Total other expenses | -3,468 | -163 | -6,617 | -1,481 |
Loss before income taxes | -4,864 | -12,692 | -32,427 | -20,467 |
Benefit for income taxes | 1,301 | 2,971 | 1,223 | 5,310 |
Net loss | ($3,563) | ($9,721) | ($31,204) | ($15,157) |
Net loss per share: | ' | ' | ' | ' |
Basic and diluted | ($0.06) | ($0.16) | ($0.49) | ($0.26) |
Weighted average shares outstanding: | ' | ' | ' | ' |
Basic and diluted | 64,609,197 | 58,977,295 | 64,119,441 | 58,995,735 |
Condensed_Consolidated_Stateme1
Condensed Consolidated Statements of Comprehensive Loss (USD $) | 3 Months Ended | 6 Months Ended | ||
In Thousands, unless otherwise specified | Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 |
Statement Of Partners Capital [Abstract] | ' | ' | ' | ' |
Net loss | ($3,563) | ($9,721) | ($31,204) | ($15,157) |
Other comprehensive income, net of income tax: | ' | ' | ' | ' |
Unrealized gain on available-for-sale securities | 741 | 99 | 1,055 | 967 |
Income tax on unrealized gain on available-for-sale securities | -279 | 57 | -398 | 171 |
Foreign currency translation adjustments | 95 | -37 | 183 | -361 |
Other comprehensive income | 557 | 119 | 840 | 777 |
Total comprehensive loss | ($3,006) | ($9,602) | ($30,364) | ($14,380) |
Condensed_Consolidated_Stateme2
Condensed Consolidated Statements of Cash Flows (USD $) | 6 Months Ended | |
In Thousands, unless otherwise specified | Jun. 30, 2014 | Jun. 30, 2013 |
Cash Flows From Operating Activities: | ' | ' |
Net loss | ($31,204) | ($15,157) |
Adjustments to reconcile net loss to net cash used in operating activities: | ' | ' |
Amortization of deferred service revenue | ' | -10,300 |
Depreciation and amortization | 12,179 | 10,772 |
Stock-based compensation | 5,525 | 5,671 |
Accretion of debt discount to interest expense on 2018 Convertible Notes (Note 11) | 2,332 | ' |
Amortization of deferred financing costs to interest expense on 2018 Convertible Notes (Note 11) | 308 | ' |
Bad debt (recovery) expense | -28 | 44 |
Impairment of intangible assets | ' | 1,023 |
Unrealized foreign currency loss | 606 | 654 |
Research and development expense for the value of stock issued to TopoTarget in connection with milestone achievement (Note 13) | 40,832 | 22,343 |
Change in fair value of contingent consideration related to acquisitions (Note 9) | 1,729 | ' |
Change in fair value of drug development liability (Note 12) | ' | -2,869 |
Changes in operating assets and liabilities: | ' | ' |
Accounts receivable | -7,231 | 39,746 |
Other receivables | -4,263 | ' |
Inventories | 2,638 | -834 |
Prepaid expenses and other current assets | -197 | -5,691 |
Deferred tax assets | 72 | -6,039 |
Other assets | -1,873 | ' |
Accounts payable and other accrued obligations | -10,659 | -11,495 |
Accrued payroll and benefits | -1,723 | -472 |
Drug development liability (Note 12) | -554 | -2,352 |
Deferred revenue | -123 | ' |
Deferred tax liability | 602 | ' |
Other long-term liabilities | -256 | 743 |
Net cash (used in) provided by operating activities | -24,330 | 3,444 |
Cash Flows From Investing Activities: | ' | ' |
Acquisition of C-E MELPHALAN license (Note 9) | ' | -3,000 |
Redemption of certificate of deposit | 165 | ' |
Purchases of property and equipment | -605 | -127 |
Net cash used in investing activities | -440 | -3,127 |
Cash Flows From Financing Activities: | ' | ' |
Proceeds from exercise of stock options | 1,339 | 1,137 |
Proceeds from sale of stock under employee stock purchase plan | 348 | 197 |
Payments to acquire treasury stock | ' | -1,652 |
Purchase and retirement of restricted stock to satisfy employee tax liability at vesting | -590 | -410 |
Proceeds from Mundipharma related to FOLOTYN collaboration (Note 12) | ' | 7,000 |
Proceeds from revolving line of credit | ' | 100,000 |
Repayment of revolving line of credit | ' | -125,000 |
Net cash provided by (used in) financing activities | 1,097 | -18,728 |
Effect of exchange rates on cash | -228 | -184 |
Net (decrease) increase in cash and cash equivalents | -23,901 | -18,595 |
Cash and cash equivalents-beginning of period | 156,306 | 139,698 |
Cash and cash equivalents-end of period | 132,405 | 121,103 |
Supplemental disclosure of cash flow information: | ' | ' |
C-E MELPHALAN license included in intangible assets and other long term obligations | ' | 4,700 |
Retirement of treasury shares | ' | 1,652 |
Cash paid for income taxes | 329 | 197 |
Cash paid for interest | 1,588 | 421 |
TopoTarget [Member] | ' | ' |
Adjustments to reconcile net loss to net cash used in operating activities: | ' | ' |
Research and development expense for the value of stock issued to TopoTarget in connection with milestone achievement (Note 13) | $7,790 | ' |
Description_of_Business_Basis_
Description of Business, Basis of Presentation, and Operating Segment | 6 Months Ended | |||
Jun. 30, 2014 | ||||
Accounting Policies [Abstract] | ' | |||
Description of Business, Basis of Presentation, and Operating Segment | ' | |||
1. DESCRIPTION OF BUSINESS, BASIS OF PRESENTATION, AND OPERATING SEGMENT | ||||
(a) Description of Business | ||||
Spectrum Pharmaceuticals, Inc. and its wholly-owned subsidiaries (“Spectrum”, the “Company”, “we”, “our”, or “us”), is a biotechnology company with fully integrated commercial and drug development operations, with a primary focus in oncology and hematology. Our strategy is comprised of acquiring, developing, and marketing a diverse pipeline of late-stage clinical and commercial products. | ||||
We currently market five drugs for the following indications: | ||||
• | FUSILEV® injection for patients in the U.S. with advanced metastatic colorectal cancer and to counteract certain effects of methotrexate therapy; | |||
• | ZEVALIN® injection for patients in the U.S. and various international markets with follicular non-Hodgkin’s lymphoma; | |||
• | FOLOTYN® injection for patients in the U.S. with relapsed or refractory peripheral T-cell lymphoma (“PTCL”); | |||
• | MARQIBO® injection for patients in the U.S. with Philadelphia chromosome–negative acute lymphoblastic leukemia; and | |||
• | BELEODAQ™ injection for patients in the U.S. with relapsed or refractory PTCL. We did not launch this product until July 2014, and accordingly, no corresponding revenue is reported for any period presented in the accompanying Condensed Consolidated Financial Statements. | |||
We also have ongoing indication expansion studies with several of our marketed products, and a diversified pipeline of product candidates in advanced-stage Phase 2 and Phase 3 studies. Our integrated in-house scientific team, includes formulation development and medical research, as well as expertise in regulatory and clinical affairs, biostatistics, and data management. In the U.S., we have full commercial operations for the sales and marketing of our drug products, and leverage the expertise of our worldwide partners to assist us with international sales and product development. | ||||
(b) Basis of Presentation | ||||
Interim Financial Statements | ||||
The interim financial data as of June 30, 2014 and 2013 is unaudited and is not necessarily indicative of the 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 and six months ended June 30, 2014 and 2013. Certain information and footnote disclosures normally included in annual financial statements prepared in accordance with generally accepted accounting principles in the United States of America (“GAAP”) have been condensed or omitted pursuant to U.S. Securities and Exchange Commission (“SEC”) rules and regulations relating to interim financial statements. 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, 2013, filed with the SEC on March 12, 2014. | ||||
Principles of Consolidation | ||||
The accompanying Condensed Consolidated Financial Statements include the financial position, results of operations, and cash flows of Spectrum and its subsidiaries, all of which are wholly-owned (except for SPC, as discussed below). All inter-company accounts and transactions among the consolidated entities have been eliminated in consolidation. | ||||
Variable Interest Entity | ||||
We own fifty-percent of Spectrum Pharma Canada (“SPC”), organized in Quebec, Canada in January 2008. SPC is a “variable interest entity” as defined under applicable GAAP. Certain of our drug clinical studies are conducted through this entity, and we are obligated to fund all of its costs and have the sole rights to any revenue derived from its operations. Since we carry the full risks and rewards of this entity, we meet the applicable GAAP 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 and six months ended June 30, 2014 and 2013, all of our revenue and related expenses were solely attributable to these activities. Substantially all of our long-lived assets are located in the U.S. |
Use_of_Estimates_and_Summary_o
Use of Estimates and Summary of Significant Accounting Policies | 6 Months Ended | ||
Jun. 30, 2014 | |||
Accounting Policies [Abstract] | ' | ||
Use of Estimates and Summary of Significant Accounting Policies | ' | ||
2. USE OF ESTIMATES AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |||
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 and liabilities, revenues and expenses, and related disclosure of contingent liabilities. On an on-going basis, our management evaluates its estimates, including those related to (i) gross-to-net revenue adjustments; (ii) the collectability of customer accounts; (iii) whether the cost of inventories can be recovered; (iv) the fair value of goodwill and intangible assets; (v) the realization of tax assets and estimates of tax liabilities; (vi) the likelihood of payment and value of contingent liabilities; (vii) the fair value of investments; (viii) assumptions used in reporting stock-based compensation; and (ix) the potential outcome of ongoing or threatened litigation. | |||
Such estimates are based on our management’s professional judgment which takes into account our Company’s experience and all available facts. Nonetheless, actual results may materially differ from management’s estimates. In our judgment, the accounting policies, estimates, and assumptions described below have the greatest potential to significantly impact the accompanying Condensed Consolidated Financial Statements: | |||
(i) Revenue Recognition | |||
(a) Product Sales: We sell our products to wholesalers and distributors. Our wholesalers and distributors in turn sell the products directly to end-users, such as clinics, hospitals, and private oncology-based practices. Revenue from product sales is recognized when title and risk of loss have transferred to our customer, and the following additional criteria are met: | |||
-1 | appropriate evidence of a binding arrangement exists with our customer; | ||
-2 | price is substantially fixed and determinable; | ||
-3 | collection from our customer is reasonably assured; | ||
-4 | our customer’s obligation to pay us is not contingent on resale of the product; | ||
-5 | we do not have significant obligations for future performance to directly bring about the resale of our product; and | ||
-6 | we have a reasonable basis to estimate returns. | ||
Our gross revenue is reduced by our gross-to-net (“GTN”) estimates, resulting in our reported “Product sales, net” in the accompanying Condensed Consolidated Statements of Operations. We defer revenue recognition in full if/when these estimates are not reasonably determinable at the time of sale. Information from external sources is used to estimate GTN adjustments. Such information includes written and oral information obtained from our wholesalers with respect to their inventory levels and sell-through to end-users during the period. The inventory information received from wholesalers is a product of their recordkeeping process. Our GTN estimates reduce revenue in the same period that the related sale is recorded and include the following major categories: | |||
Product Returns Allowances: Our FUSILEV and MARQIBO customers (and BELEODAQ customers, beginning in the third quarter of 2014) are typically permitted to return products within six months of its expiration date, subject to certain restocking fees and preauthorization requirements. Returns for ZEVALIN and FOLOTYN expirations are not contractually or customarily allowed. We estimate potential returns, based on several factors, including historical rates of return, customer and end-user ordering patterns, inventory held by distributors, and sell through data of distributor sales to end users. In general, returned product is not resold. | |||
Government Chargebacks: Our products are subject to certain pricing limits under federal government programs. Qualifying entities purchase products through our distributors at the discounted price. Our distributors charge the difference between the list price and discounted price back to us, for which there may be significant lag time. Due to estimates inherent in determining the amount and volume of government chargebacks we will incur, the actual amount of government chargeback claims may be materially different from our estimates. | |||
Discounts: Discounts for prompt payment are estimated based on the customer’s payment history and our current expectations for timing of customer payment. | |||
Rebates: Rebates are estimated based on the customer’s actual purchase level during the quarterly or annual rebate purchase period, and the corresponding contractual rebate tier we expect the customer to achieve. | |||
Medicaid Rebates: Our products are subject to state government-managed Medicaid programs whereby discounts and rebates are provided to participating state governments. Our calculations related to these rebate accruals require estimates, including estimates of customer mix, to determine which of our sales will be subject to rebates and the amount of such rebates. Our estimates are based on historical claims and forecasting techniques, as supplemented by management’s judgment for many factors, including changes in sales trends and product pricing. Due to estimates and assumptions inherent in determining the amount of our product sales that will be subject to Medicaid rebates, and the time lag in us receiving these rebate notices (generally several months after the sale is made), the actual amount of these claims may be materially different from our estimates. As a result, Medicaid rebate adjustments affecting revenue may be prospectively recorded and reported over several periods after we reported the initial sale. | |||
Distribution, Data, and GPO Administrative Fees: Distribution, data, and GPO administrative fees are paid to authorized wholesalers and specialty distributors of our products (except U.S. sales of ZEVALIN). These fees are based on a percentage of such estimated net sales and are for various services, including: contract administration, inventory management, product sales reporting by customer, and product returns processing. | |||
(b) License Fees: We recognize revenue for our licensing of intellectual property to third parties, based on the terms of each contractual agreement. In general, this results in periodic revenue recognition as the licensee has sales for which we are entitled to a royalty, or in certain instances we may receive a lump-sum payment from licensees, in which case, revenue is fully recognized in that period. | |||
(c) Service Revenue: We receive fees under certain arrangements for our research and development services. These services are generally performed in connection with a collaboration agreement with another pharmaceutical company. Payment may be triggered by the successful completion of a phase of development, results from a clinical trial, and/or regulatory approval events. We recognize revenue when the corresponding milestone is achieved, or the revenue is otherwise earned through our on-going activities. | |||
ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606) (“ASU 2014-09”), was issued in May 2014 for our mandatory adoption beginning January 1, 2017 (no early adoption is permitted under this new revenue recognition standard). ASU 2014-09 requires an entity to recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. To achieve this core principle, the guidance provides that an entity should apply the following steps: (1) identify the contract(s) with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when, or as, the entity satisfies a performance obligation. We continue to evaluate the impact of ASU 2014-09 to our current revenue recognition models for product sales, license fees, and service revenue, as described above. | |||
(ii) Cash and Equivalents | |||
Our cash and equivalents consist of bank deposits and highly liquid investments with original maturities of three months or less from the original purchase date. | |||
(iii) Marketable Securities | |||
Our marketable securities consist of our holdings in mutual funds and bank certificates of deposit. These are classified as available-for-sale, with any unrealized change in value reflected in “unrealized gain (loss) on securities” on the accompanying Condensed Consolidated Statements of Comprehensive Income (Loss). Realized gains and losses on available-for-sale securities are included in “other expense” on the accompanying Condensed Consolidated Statements of Operations. | |||
(iv) Accounts Receivable | |||
Our accounts receivable are derived from our product sales, license fees, and service revenue, and do not bear interest. The allowance for doubtful accounts is management’s best estimate of the amount of probable credit losses in existing accounts receivable. Account balances are charged off against the allowance after appropriate collection efforts are exhausted. | |||
(v) Inventories | |||
We value inventory at the lower of the actual cost to purchase or manufacture it, or its market value (i.e., its net realizable value). Cost is determined on the first-in, first-out method (FIFO). We regularly review inventory quantities in process and on hand, and when appropriate, record a provision for obsolete and excess inventory to reduce it to its net realizable value. | |||
Direct and indirect manufacturing costs related to the production of inventory in anticipation of FDA approval are expensed through “research and development,” rather than capitalized. Upon FDA approval, these direct and indirect manufacturing costs are subsequently capitalized to inventory as incurred. | |||
(vi) Property and Equipment | |||
Our property and equipment is stated at cost and depreciated on a straight-line basis over its estimated useful lives. In the case of leasehold improvements, depreciation is over the shorter of the estimated useful life or remaining term of the lease. We evaluate the recoverability of long-lived assets (which includes property and equipment) whenever events or changes in circumstances in our business indicate that the asset’s carrying amount may not be recoverable through on-going operations. | |||
(vii) Goodwill and Intangible Assets | |||
Our goodwill represents the excess of our business acquisition cost over the estimated fair value of the net assets acquired in the corresponding transactions. Goodwill has an indefinite useful life and is not amortized, but is instead tested for impairment on an annual basis, unless there are interim impairment indicators requiring earlier testing. We perform our annual evaluation as of October 1 each year. | |||
We evaluate the recoverability of indefinite and definite lived intangible assets at least annually, or whenever events or changes in our business indicate that an intangible asset’s 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. | ||
(viii) Stock-Based Compensation | |||
We recognize stock-based compensation expense for employees and directors over the equity award vesting period, on a straight-line basis, and is net of an estimated forfeiture rate which is periodically updated. | |||
We use the Black-Scholes option pricing model to determine the fair value of stock option grants with service conditions for vesting, and the Monte Carlo valuation model to value equity awards with combined market conditions and service conditions for vesting. These models require the use of highly subjective assumptions, including the volatility of our stock price and the probability of the achievement of market capitalization thresholds. | |||
(ix) Foreign Currency Translation and Transactions | |||
We translate the assets and liabilities of our foreign subsidiaries stated in local functional currencies to U.S. dollars at the rates of exchange in effect at the end of the period. Revenues and expenses are translated using rates of exchange in effect during the period. Gains and losses from the translation of financial statements denominated in the foreign functional currency are included as a separate component of “accumulated other comprehensive loss” in the Condensed Consolidated Balance Sheets. | |||
We record foreign currency transactions, when denominated in something other than the respective functional currency of our applicable legal entity, at the exchange rate prevailing at the date of the transaction. Resulting unrealized and realized gains and losses are included in “other income (expense), net” within the Condensed Consolidated Statements of Operations. Foreign currency transaction gains and losses have not been significant for any period presented. | |||
(x) Basic and Diluted Net (Loss) Income per Share | |||
We calculate basic and diluted net (loss) income per share using the weighted average number of common shares outstanding during the periods presented. In periods of a net loss, basic and diluted loss per share are the same. For the diluted earnings per share calculation, we adjust the weighted average number of common shares outstanding to include only dilutive stock options, warrants, and other common stock equivalents outstanding during the period. | |||
(xi) Income Taxes | |||
Deferred tax assets and liabilities are recorded based on the estimated future tax effects of temporary differences between the tax basis of assets and liabilities and amounts reported in the financial statements, as well as operating losses and tax credit carry forwards using enacted tax rates and laws that are expected to be in effect when the differences are expected to reverse. Realization of deferred tax assets is dependent upon future earnings, the timing and amount of which are uncertain. | |||
We have recorded a valuation allowance to reduce our 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 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, such amounts would be included in “income tax benefit (expense)” within the Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) in the period the notice was received. | |||
(xii) Research and Development Costs | |||
Our research and development costs are expensed as incurred. | |||
(xiii) Fair Value Measurements | |||
We determine measurement-date fair value based on the proceeds that would be received through the sale an asset, or that we would pay to settle or transfer a liability, in an orderly transaction between market participants. We utilize valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible. Fair value measurements are based on a three-tier hierarchy that prioritizes the inputs used to measure fair value. These tiers include the following: | |||
Level 1: Quoted prices (unadjusted) in active markets for identical assets or liabilities that are publicly accessible at the measurement date. | |||
Level 2: Observable prices that are based on inputs not quoted on active markets, but that are corroborated by market data. These inputs may include quoted prices for similar assets or liabilities or quoted market prices in markets that are not active to the general public. | |||
Level 3: Unobservable inputs are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs. | |||
“Cash and cash equivalents” within our accompanying Condensed Consolidated Balance Sheets include certificates of deposit and money market funds that are valued utilizing Level 2 inputs. “Marketable securities” consist of mutual funds that are also valued utilizing Level 2 inputs. | |||
“Other assets” within our accompanying Condensed Consolidated Balance Sheets include equity securities that are valued using Level 1 inputs. | |||
The fair value of our “drug development liability” within our accompanying Condensed Consolidated Balance Sheets was estimated using the discounted income approach model. The unobservable inputs (i.e., Level 3 inputs) in this valuation model that have the most significant effect on these liabilities include (i) estimates of research and development personnel costs needed to perform the research and development services, (ii) estimates of expected cash outflows to third parties for services and supplies over the expected period that the services will be performed, and (iii) an appropriate discount rate for these expenditures. These inputs are reviewed for reasonableness by management on at least on a quarterly basis. | |||
“Acquisition-related contingent obligations” within our accompanying Condensed Consolidated Balance Sheets represent future amounts we may be required to pay in conjunction with various business combinations. See Note 9(a) for a discussion of contingent value rights granted as part of our acquisition of Talon, and Note 9(b) for the fair value of the liability associated with FDA approval of C-E MELPHALAN. These liabilities are valued using Level 3 inputs and include probabilities and assumptions related to the timing and likelihood of achievement of regulatory and sales milestones. |
Balance_Sheet_Account_Detail
Balance Sheet Account Detail | 6 Months Ended | ||||||||||||||||||||||||||||
Jun. 30, 2014 | |||||||||||||||||||||||||||||
Text Block [Abstract] | ' | ||||||||||||||||||||||||||||
Balance Sheet Account Detail | ' | ||||||||||||||||||||||||||||
3. 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 June 30, 2014 and December 31, 2013, our holdings included within “cash and cash equivalents” and “marketable securities” were at major financial institutions. | |||||||||||||||||||||||||||||
Our investment policy requires that investments in marketable securities be in only highly-rated instruments, which are primarily U.S. treasury bills or U.S. treasury-backed securities, with limitations on investing in securities of any single issuer. We maintain cash balances in excess of federally insured limits with reputable financial institutions. To a limited degree, the Federal Deposit Insurance Corporation (FDIC) and other third parties insure these investments. However, these investments are not insured against the possibility of a complete loss of earnings or principal and are inherently subject to the credit risk related to the continued credit worthiness of the underlying issuer and general credit market risks. We manage such risks on our portfolio by investing in highly liquid, highly rated instruments, and limit investing in long-term maturity instruments. | |||||||||||||||||||||||||||||
The carrying amount of our money market funds, bank certificate of deposits (“Bank CDs”), and mutual funds approximates their fair value (utilizing 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 “cash and cash equivalents” and “marketable securities”: | |||||||||||||||||||||||||||||
Cost | Gross | Gross | Estimated | Cash and cash | Marketable Securities | ||||||||||||||||||||||||
Unrealized | Unrealized | fair | equivalents | ||||||||||||||||||||||||||
Gains | Losses | Value | Current | Long | |||||||||||||||||||||||||
Term | |||||||||||||||||||||||||||||
June 30, 2014 | |||||||||||||||||||||||||||||
Bank deposits | $ | 59,443 | $ | — | $ | — | $ | 59,443 | $ | 59,443 | $ | — | $ | — | |||||||||||||||
Money market funds | 72,962 | — | — | 72,962 | 72,962 | — | — | ||||||||||||||||||||||
Bank CDs | 245 | — | — | 245 | — | 245 | — | ||||||||||||||||||||||
Mutual funds | 3,061 | — | — | 3,061 | — | 3,061 | — | ||||||||||||||||||||||
Total cash and equivalents and marketable securities | $ | 135,711 | $ | — | $ | — | $ | 135,711 | $ | 132,405 | $ | 3,306 | $ | — | |||||||||||||||
December 31, 2013 | |||||||||||||||||||||||||||||
Bank deposits | $ | 55,911 | $ | — | $ | — | $ | 55,911 | $ | 55,911 | $ | — | $ | — | |||||||||||||||
Money market funds | 100,395 | — | — | 100,395 | 100,395 | — | — | ||||||||||||||||||||||
Bank CDs | 410 | — | — | 410 | — | 410 | — | ||||||||||||||||||||||
Mutual funds | 3,061 | — | — | 3,061 | — | 3,061 | — | ||||||||||||||||||||||
Total cash and equivalents and marketable securities | $ | 159,777 | $ | — | $ | — | $ | 159,777 | $ | 156,306 | $ | 3,471 | $ | — | |||||||||||||||
As of June 30, 2014, none of these securities had been in a continuous unrealized loss position longer than one year. | |||||||||||||||||||||||||||||
(b) Property and Equipment | |||||||||||||||||||||||||||||
“Property and equipment, net of accumulated depreciation” consist of the following: | |||||||||||||||||||||||||||||
June 30, | December 31, | ||||||||||||||||||||||||||||
2014 | 2013 | ||||||||||||||||||||||||||||
Computer hardware and software | $ | 3,258 | $ | 5,154 | |||||||||||||||||||||||||
Laboratory equipment | 648 | 1,063 | |||||||||||||||||||||||||||
Office furniture | 372 | 1,575 | |||||||||||||||||||||||||||
Leasehold improvements | 2,858 | 2,813 | |||||||||||||||||||||||||||
Property and equipment, at cost | 7,136 | 10,605 | |||||||||||||||||||||||||||
(Less): Accumulated depreciation | (5,729 | ) | (9,070 | ) | |||||||||||||||||||||||||
Property and equipment, net of accumulated depreciation | $ | 1,407 | $ | 1,535 | |||||||||||||||||||||||||
Depreciation expense (included within “operating costs and expenses” in the accompanying Condensed Consolidated Statement of Operations) for the six months ended June 30, 2014 and 2013, was $0.7 million in each period. During the three months ended June 30, 2014, we corrected our property and equipment to remove assets which were determined to no longer be in use (property and equipment at cost of $4.2 million, less accumulated depreciation of $4.0 million). | |||||||||||||||||||||||||||||
(c) Inventories | |||||||||||||||||||||||||||||
“Inventories” consist of the following: | |||||||||||||||||||||||||||||
June 30, | December 31, | ||||||||||||||||||||||||||||
2014 | 2013 | ||||||||||||||||||||||||||||
Raw materials | $ | 2,092 | $ | 1,794 | |||||||||||||||||||||||||
Work-in-process | 2,095 | 3,312 | |||||||||||||||||||||||||||
Finished goods | 6,694 | 8,413 | |||||||||||||||||||||||||||
$ | 10,881 | $ | 13,519 | ||||||||||||||||||||||||||
(d) Prepaid expenses and other current assets | |||||||||||||||||||||||||||||
“Prepaid expenses and other current assets” consist of the following: | |||||||||||||||||||||||||||||
June 30, | December 31, | ||||||||||||||||||||||||||||
2014 | 2013 | ||||||||||||||||||||||||||||
Prepaid operating expenses | $ | 3,166 | $ | 3,213 | |||||||||||||||||||||||||
Research and development supplies | 244 | — | |||||||||||||||||||||||||||
$ | 3,410 | $ | 3,213 | ||||||||||||||||||||||||||
(e) Other receivables | |||||||||||||||||||||||||||||
“Other receivables” consist of the (i) amounts we expect to be refunded from taxing authorities for our income taxes paid, relating to fiscal year 2012 and the (ii) amounts we expect to be reimbursed from certain of our product development partners for incurred drug development expenses. | |||||||||||||||||||||||||||||
June 30, | December 31, | ||||||||||||||||||||||||||||
2014 | 2013 | ||||||||||||||||||||||||||||
Income tax receivable | $ | 9,098 | $ | 7,539 | |||||||||||||||||||||||||
Product development expenses—reimbursement receivables | 2,704 | — | |||||||||||||||||||||||||||
$ | 11,802 | $ | 7,539 | ||||||||||||||||||||||||||
(f) Intangible Assets and Goodwill | |||||||||||||||||||||||||||||
“Intangible assets, net of accumulated amortization” consist of the following: | |||||||||||||||||||||||||||||
June 30, 2014 | |||||||||||||||||||||||||||||
Historical | Accumulated | Foreign | Impairment | Net Amount | Full | Remaining | |||||||||||||||||||||||
Cost | Amortization | Currency | Amortization | Amortization | |||||||||||||||||||||||||
Translation | Period (years) | Period (years) | |||||||||||||||||||||||||||
MARQIBO IPR&D (NHL indication) | $ | 17,600 | $ | — | $ | — | $ | — | $ | 17,600 | n/a | n/a | |||||||||||||||||
C-E MELPHALAN IPR&D | 7,700 | — | — | — | 7,700 | n/a | n/a | ||||||||||||||||||||||
MARQIBO distribution rights | 26,900 | (2,366 | ) | — | — | 24,534 | 11 | 9.7 | |||||||||||||||||||||
FOLOTYN distribution rights | 118,400 | (15,308 | ) | — | — | 103,092 | 13 | 10.9 | |||||||||||||||||||||
ZEVALIN distribution rights – U.S. | 41,900 | (25,315 | ) | — | — | 16,585 | 10 | 4.5 | |||||||||||||||||||||
ZEVALIN distribution rights – Ex-U.S. | 23,490 | (6,804 | ) | 453 | — | 17,139 | 8 | 5.6 | |||||||||||||||||||||
FUSILEV distribution rights | 16,778 | (5,546 | ) | — | — | 11,232 | 11 | 7.7 | |||||||||||||||||||||
FOLOTYN out-license* | 27,900 | (5,024 | ) | — | (1,023 | ) | 21,853 | 10 | 8 | ||||||||||||||||||||
Total intangible assets | $ | 280,668 | $ | (60,363 | ) | $ | 453 | $ | (1,023 | ) | $ | 219,735 | |||||||||||||||||
* | On May 29, 2013, we amended our collaboration agreement with Mundipharma in order to modify the scope of their licensed territories and the respective development obligations. As a result of the amendment, Europe and Turkey were excluded from Mundipharma’s commercialization territory, and royalty and milestone rates were modified. The modification of our associated royalty and milestone rights constituted a change in the contractual provisions under which we measured our original acquired intangible asset (i.e., FOLOTYN rights). We determined that an impairment of the FOLOTYN out-license rights to Mundipharma of $1.0 million resulted from this amendment. | ||||||||||||||||||||||||||||
December 31, 2013 | |||||||||||||||||||||||||||||
Historical | Accumulated | Foreign | Impairment | Net Amount | |||||||||||||||||||||||||
Cost | Amortization | Currency | |||||||||||||||||||||||||||
Translation | |||||||||||||||||||||||||||||
MARQIBO IPR&D (NHL indication) | $ | 17,600 | $ | — | $ | — | $ | — | $ | 17,600 | |||||||||||||||||||
C-E MELPHALAN IPR&D | 7,700 | — | — | — | 7,700 | ||||||||||||||||||||||||
MARQIBO distribution rights (ALL indication) | 26,900 | (1,107 | ) | — | — | 25,793 | |||||||||||||||||||||||
FOLOTYN distribution rights | 118,400 | (10,587 | ) | — | — | 107,813 | |||||||||||||||||||||||
ZEVALIN distribution rights – U.S. | 41,900 | (23,455 | ) | — | — | 18,445 | |||||||||||||||||||||||
ZEVALIN distribution rights – Ex-U.S. | 23,490 | (5,343 | ) | 682 | — | 18,829 | |||||||||||||||||||||||
FUSILEV distribution rights | 16,778 | (4,821 | ) | — | — | 11,957 | |||||||||||||||||||||||
FOLOTYN out-license | 27,900 | (3,662 | ) | — | (1,023 | ) | 23,215 | ||||||||||||||||||||||
Total intangible assets | $ | 280,668 | $ | (48,975 | ) | $ | 682 | $ | (1,023 | ) | $ | 231,352 | |||||||||||||||||
Intangible asset amortization expense recognized in the six months ended June 30, 2014 and 2013 was $11.4 million and $9.9 million, respectively. Estimated intangible asset amortization expense (excluding incremental amortization from the reclassification of IPR&D to developed technology) for the remainder of 2014 and the five succeeding fiscal years and thereafter is as follows: | |||||||||||||||||||||||||||||
Years Ending December 31 | |||||||||||||||||||||||||||||
Remainder of 2014 | $ | 11,438 | |||||||||||||||||||||||||||
2015 | 22,877 | ||||||||||||||||||||||||||||
2016 | 22,877 | ||||||||||||||||||||||||||||
2017 | 22,877 | ||||||||||||||||||||||||||||
2018 | 22,722 | ||||||||||||||||||||||||||||
2019 | 19,157 | ||||||||||||||||||||||||||||
2020 and thereafter | 72,487 | ||||||||||||||||||||||||||||
$ | 194,435 | ||||||||||||||||||||||||||||
“Goodwill” is comprised of the following (by source): | |||||||||||||||||||||||||||||
June 30, | December 31, | ||||||||||||||||||||||||||||
2014 | 2013 | ||||||||||||||||||||||||||||
Acquisition of Talon | $ | 10,526 | $ | 10,526 | |||||||||||||||||||||||||
Acquisition of ZEVALIN Ex-U.S. distribution rights | 2,525 | 2,525 | |||||||||||||||||||||||||||
Acquisition of Allos | 5,346 | 5,346 | |||||||||||||||||||||||||||
Foreign currency exchange translation effects | 79 | 104 | |||||||||||||||||||||||||||
$ | 18,476 | $ | 18,501 | ||||||||||||||||||||||||||
(g) Other assets | |||||||||||||||||||||||||||||
“Other assets” are comprised of the following: | |||||||||||||||||||||||||||||
June 30, | December 31, | ||||||||||||||||||||||||||||
2014 | 2013 | ||||||||||||||||||||||||||||
Investments in equity securities | $ | 4,648 | $ | 3,593 | |||||||||||||||||||||||||
Supplies and other assets | 691 | — | |||||||||||||||||||||||||||
Deposits | 193 | 190 | |||||||||||||||||||||||||||
2018 Convertible Notes issuance costs | 3,124 | 3,432 | |||||||||||||||||||||||||||
Executive officer life insurance – cash surrender value | 6,541 | 5,362 | |||||||||||||||||||||||||||
$ | 15,197 | $ | 12,577 | ||||||||||||||||||||||||||
(h) Accounts payable and other accrued liabilities | |||||||||||||||||||||||||||||
“Accounts payable and other accrued liabilities” are comprised of the following: | |||||||||||||||||||||||||||||
June 30, | December 31, | ||||||||||||||||||||||||||||
2014 | 2013 | ||||||||||||||||||||||||||||
Trade payables | $ | 7,620 | $ | 12,796 | |||||||||||||||||||||||||
Accrued research and development expenses | 3,915 | 6,433 | |||||||||||||||||||||||||||
Accrued selling, general and administrative expenses | 7,591 | 8,870 | |||||||||||||||||||||||||||
Accrued rebates | 34,842 | 28,893 | |||||||||||||||||||||||||||
Accrued product royalty | 3,599 | 9,498 | |||||||||||||||||||||||||||
Allowance for returns | 1,500 | 2,900 | |||||||||||||||||||||||||||
Accrued data and distribution fees | 2,934 | 2,430 | |||||||||||||||||||||||||||
Accrued GPO administrative fees | 2,684 | 2,327 | |||||||||||||||||||||||||||
Inventory management fee | 845 | 616 | |||||||||||||||||||||||||||
Allowance for chargebacks | 3,648 | 5,074 | |||||||||||||||||||||||||||
$ | 69,178 | $ | 79,837 | ||||||||||||||||||||||||||
Amounts presented within “accounts payable and other accrued liabilities” in the accompanying Condensed Consolidated Balance Sheets specifically for GTN estimates (see Note 2(i)) are as follows: | |||||||||||||||||||||||||||||
Description | Rebates and | Data and | Prompt | Returns | |||||||||||||||||||||||||
Chargebacks | Distribution, | Pay | |||||||||||||||||||||||||||
GPO Fees, and | Discount | ||||||||||||||||||||||||||||
Inventory | |||||||||||||||||||||||||||||
Management | |||||||||||||||||||||||||||||
Fees | |||||||||||||||||||||||||||||
Balance as of December 31, 2012 | $ | 26,176 | $ | 14,149 | $ | 1,451 | $ | 5,056 | |||||||||||||||||||||
Add: provisions (recovery) | 63,609 | 19,067 | 183 | (2,034 | ) | ||||||||||||||||||||||||
(Less): credits or actual allowances | (55,818 | ) | (27,843 | ) | (1,317 | ) | (122 | ) | |||||||||||||||||||||
Balance as of December 31, 2013 | 33,967 | 5,373 | 317 | 2,900 | |||||||||||||||||||||||||
Add: provisions (recovery) | 34,721 | 9,416 | 5 | (1,265 | ) | ||||||||||||||||||||||||
(Less): credits or actual allowances | (30,198 | ) | (8,326 | ) | (281 | ) | (135 | ) | |||||||||||||||||||||
Balance as of June 30, 2014 | $ | 38,490 | $ | 6,463 | $ | 41 | $ | 1,500 | |||||||||||||||||||||
(i) Other long-term liabilities | |||||||||||||||||||||||||||||
Other long-term liabilities are comprised of the following: | |||||||||||||||||||||||||||||
June 30, | December 31, | ||||||||||||||||||||||||||||
2014 | 2013 | ||||||||||||||||||||||||||||
Accrued executive deferred compensation | $ | 4,527 | $ | 3,949 | |||||||||||||||||||||||||
Deferred rent (non-current portion) | 451 | 366 | |||||||||||||||||||||||||||
Business acquisition liability | — | 298 | |||||||||||||||||||||||||||
Other tax liabilities | 731 | 1,352 | |||||||||||||||||||||||||||
$ | 5,709 | $ | 5,965 |
GrosstoNet_Product_Sales
Gross-to-Net Product Sales | 6 Months Ended | ||||||||||||||||
Jun. 30, 2014 | |||||||||||||||||
Text Block [Abstract] | ' | ||||||||||||||||
Gross-to-Net Product Sales | ' | ||||||||||||||||
4. GROSS-TO-NET PRODUCT SALES | |||||||||||||||||
The below table presents a GTN product sales reconciliation for the accompanying Condensed Consolidated Statement of Operations: | |||||||||||||||||
Three months ended | Six months ended | ||||||||||||||||
June 30, | June 30, | ||||||||||||||||
2014 | 2013 | 2014 | 2013 | ||||||||||||||
Gross product sales | $ | 68,329 | $ | 57,522 | $ | 129,828 | $ | 100,494 | |||||||||
Rebates and chargebacks | (17,772 | ) | (20,365 | ) | (34,721 | ) | (31,083 | ) | |||||||||
Data, distribution and GPO administrative fees | (4,920 | ) | (5,704 | ) | (9,416 | ) | (10,046 | ) | |||||||||
Prompt pay discount | (2 | ) | (13 | ) | (5 | ) | (105 | ) | |||||||||
Product returns allowance | 1,220 | 773 | 1,265 | 2,299 | |||||||||||||
Product sales, net | $ | 46,855 | $ | 32,213 | $ | 86,951 | $ | 61,559 | |||||||||
Product_Sales_Net_by_Geographi
Product Sales, Net by Geographic Region and Product Line | 6 Months Ended | ||||||||||||||||||||||||||||||||
Jun. 30, 2014 | |||||||||||||||||||||||||||||||||
Text Block [Abstract] | ' | ||||||||||||||||||||||||||||||||
Product Sales, Net by Geographic Region and Product Line | ' | ||||||||||||||||||||||||||||||||
5. PRODUCT SALES, NET BY GEOGRAPHIC REGION AND PRODUCT LINE | |||||||||||||||||||||||||||||||||
The below table presents “product sales, net” by geography for the three and six months ended June 30, 2014 and 2013: | |||||||||||||||||||||||||||||||||
Three months ended June 30, | Six months ended June 30, | ||||||||||||||||||||||||||||||||
2014 | 2013 | 2014 | 2013 | ||||||||||||||||||||||||||||||
United States | $ | 44,541 | 95.1 | % | $ | 30,157 | 93.6 | % | $ | 81,998 | 94.3 | % | 57,091 | 92.7 | % | ||||||||||||||||||
International: | |||||||||||||||||||||||||||||||||
Europe | 796 | 1.7 | % | 602 | 1.9 | % | 1,836 | 2.1 | % | 1,631 | 2.6 | % | |||||||||||||||||||||
Asia Pacific | 1,518 | 3.2 | % | 1,454 | 4.5 | % | 3,117 | 3.6 | % | 2,837 | 4.6 | % | |||||||||||||||||||||
Total international | 2,314 | 4.9 | % | 2,056 | 6.4 | % | 4,953 | 5.7 | % | 4,468 | 7.3 | % | |||||||||||||||||||||
Product sales, net | $ | 46,855 | 100 | % | $ | 32,213 | 100 | % | $ | 86,951 | 100 | % | 61,559 | 100 | % | ||||||||||||||||||
The below table presents “product sales, net” by product line for the three and six months ended June 30, 2014 and 2013: | |||||||||||||||||||||||||||||||||
Three months ended June 30, | Six months ended June 30, | ||||||||||||||||||||||||||||||||
2014 | 2013 | 2014 | 2013 | ||||||||||||||||||||||||||||||
FUSILEV | $ | 26,554 | 56.7 | % | $ | 12,864 | 39.9 | % | $ | 48,747 | 56.1 | % | $ | 24,706 | 40.1 | % | |||||||||||||||||
FOLOTYN | 12,597 | 26.9 | % | 12,557 | 39 | % | 22,655 | 26.1 | % | 22,481 | 36.5 | % | |||||||||||||||||||||
ZEVALIN | 6,336 | 13.5 | % | 6,792 | 21.1 | % | 12,636 | 14.5 | % | 14,372 | 23.3 | % | |||||||||||||||||||||
MARQIBO | 1,368 | 2.9 | % | — | — | % | 2,913 | 3.4 | % | — | — | % | |||||||||||||||||||||
Product sales, net | $ | 46,855 | 100 | % | $ | 32,213 | 100 | % | $ | 86,951 | 100 | % | $ | 61,559 | 100 | % | |||||||||||||||||
StockBased_Compensation
Stock-Based Compensation | 6 Months Ended | ||||||||||||||||
Jun. 30, 2014 | |||||||||||||||||
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | ' | ||||||||||||||||
Stock-Based Compensation | ' | ||||||||||||||||
6. STOCK-BASED COMPENSATION | |||||||||||||||||
We classify our stock-based compensation expense (inclusive of our incentive stock plan, employee stock purchase plan, and 401(k) 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 “operating costs and expenses” for the three and six months ended June 30, 2014 and 2013 was as follows: | |||||||||||||||||
Three months ended | Six months ended | ||||||||||||||||
June 30, | June 30, | ||||||||||||||||
2014 | 2013 | 2014 | 2013 | ||||||||||||||
Research and development | $ | 511 | $ | 485 | $ | 955 | $ | 1,159 | |||||||||
Selling, general and administrative | 2,163 | 2,439 | 4,570 | 4,512 | |||||||||||||
Total share-based compensation | $ | 2,674 | $ | 2,924 | $ | 5,525 | $ | 5,671 | |||||||||
Net_Loss_Per_Share
Net Loss Per Share | 6 Months Ended | ||||||||||||||||
Jun. 30, 2014 | |||||||||||||||||
Earnings Per Share [Abstract] | ' | ||||||||||||||||
Net Loss Per Share | ' | ||||||||||||||||
7. 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 and six months ended June 30, 2014 and 2013: | |||||||||||||||||
Three months ended June 30, | Six months ended June 30, | ||||||||||||||||
2014 | 2013 | 2014 | 2013 | ||||||||||||||
Net loss | $ | (3,563 | ) | $ | (9,721 | ) | $ | (31,204 | ) | $ | (15,157 | ) | |||||
Weighted average shares – basic and diluted | 64,609,197 | 58,977,295 | 64,119,441 | 58,995,735 | |||||||||||||
Net loss per share – basic and diluted | $ | (0.06 | ) | $ | (0.16 | ) | $ | (0.49 | ) | $ | (0.26 | ) | |||||
The below-listed outstanding securities were excluded from our calculation of net loss per share, (using the treasury stock and if-converted method, as applicable), because their impact would have been anti-dilutive due to net loss per share in the three and six months ended June 30, 2014 and 2013: | |||||||||||||||||
Three months ended June 30, | Six months ended June 30, | ||||||||||||||||
2014 | 2013 | 2014 | 2013 | ||||||||||||||
2018 Convertible Notes | 11,401,284 | — | 11,401,284 | — | |||||||||||||
Common stock options | 2,076,157 | 2,412,230 | 2,300,525 | 3,211,911 | |||||||||||||
Restricted stock awards | 1,021,825 | 1,102,654 | 1,021,825 | 1,102,654 | |||||||||||||
Common stock warrants | 111,601 | 115,249 | 129,512 | 173,031 | |||||||||||||
Preferred stock | 40,000 | 40,000 | 40,000 | 40,000 | |||||||||||||
Total | 14,650,867 | 3,670,133 | 14,893,146 | 4,527,596 | |||||||||||||
Fair_Value_Measurements
Fair Value Measurements | 6 Months Ended | ||||||||||||||||
Jun. 30, 2014 | |||||||||||||||||
Fair Value Disclosures [Abstract] | ' | ||||||||||||||||
Fair Value Measurements | ' | ||||||||||||||||
8. FAIR VALUE MEASUREMENTS | |||||||||||||||||
The below table 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 (as described within Note 2(xiii)): | |||||||||||||||||
June 30, 2014 | |||||||||||||||||
Fair Value Measurements | |||||||||||||||||
Level 1 | Level 2 | Level 3 | Total | ||||||||||||||
Assets: | |||||||||||||||||
Bank CDs | $ | — | $ | 245 | $ | — | $ | 245 | |||||||||
Money market currency funds | — | 72,962 | — | 72,962 | |||||||||||||
Mutual funds | — | 3,061 | — | 3,061 | |||||||||||||
Deferred compensation investments, including life insurance cash surrender value | — | 6,541 | — | 6,541 | |||||||||||||
Equity securities | 4,648 | — | — | 4,648 | |||||||||||||
$ | 4,648 | $ | 82,809 | $ | — | $ | 87,457 | ||||||||||
Liabilities: | |||||||||||||||||
Deferred executive compensation liability | — | 4,527 | — | 4,527 | |||||||||||||
Drug development liability | — | — | 17,188 | 17,188 | |||||||||||||
Ligand Contingent Consideration | — | — | 4,300 | 4,300 | |||||||||||||
Talon CVR | — | — | 5,696 | 5,696 | |||||||||||||
Corixa Liability | — | — | 62 | 62 | |||||||||||||
$ | — | $ | 4,527 | $ | 27,246 | $ | 31,773 | ||||||||||
December 31, 2013 | |||||||||||||||||
Fair Value Measurements | |||||||||||||||||
Level 1 | Level 2 | Level 3 | Total | ||||||||||||||
Assets: | |||||||||||||||||
Bank CDs | $ | — | $ | 410 | $ | — | $ | 410 | |||||||||
Money market currency funds | — | 100,395 | — | 100,395 | |||||||||||||
Mutual funds | — | 3,061 | — | 3,061 | |||||||||||||
Deferred compensation investments, including life insurance cash surrender value | — | 5,362 | — | 5,362 | |||||||||||||
Equity securities | 3,593 | — | — | 3,593 | |||||||||||||
$ | 3,593 | $ | 109,228 | $ | — | $ | 112,821 | ||||||||||
Liabilities: | |||||||||||||||||
Deferred executive compensation liability | — | 3,949 | — | 3,949 | |||||||||||||
Deferred development costs | — | — | 17,742 | 17,742 | |||||||||||||
Ligand Contingent Consideration | — | — | 4,000 | 4,000 | |||||||||||||
Talon CVR | — | — | 4,329 | 4,329 | |||||||||||||
$ | — | $ | 3,949 | $ | 26,071 | $ | 30,020 | ||||||||||
The following summarizes the fair value measurement activity for our liabilities that utilize Level 3 inputs: | |||||||||||||||||
Fair Value Measurements of | |||||||||||||||||
Unobservable Inputs (Level 3) | |||||||||||||||||
Balance at December 31, 2012 | $ | 14,520 | |||||||||||||||
Transfers in (out) of Level 3 | — | ||||||||||||||||
Deferred development costs | 5,509 | ||||||||||||||||
Deferred payment contingency | (2,287 | ) | |||||||||||||||
Ligand Contingent Consideration | 4,000 | ||||||||||||||||
Talon CVR | 4,329 | ||||||||||||||||
Balance at December 31, 2013 | 26,071 | ||||||||||||||||
Transfers in (out) of Level 3 | — | ||||||||||||||||
Deferred development costs (see Note 12) | (554 | ) | |||||||||||||||
Ligand Contingent Consideration (see Note 9(b)) | 300 | ||||||||||||||||
Talon CVR (see Note 9(a)) | 1,367 | ||||||||||||||||
Corixa Liability (see Note 13(b)(i)) | 62 | ||||||||||||||||
Balance at June 30, 2014** | $ | 27,246 | |||||||||||||||
** | This amount is comprised of current and long-term portion of “drug development liability” and “acquisition-related contingent obligations” on our accompanying Condensed Consolidated Balance Sheets. |
Business_Combinations_and_Cont
Business Combinations and Contingent Consideration | 6 Months Ended | ||||
Jun. 30, 2014 | |||||
Business Combinations [Abstract] | ' | ||||
Business Combinations and Contingent Consideration | ' | ||||
9. BUSINESS COMBINATIONS AND CONTINGENT CONSIDERATION | |||||
(a) Acquisition of Talon Therapeutics, Inc. | |||||
Talon Acquisition Overview | |||||
On July 17, 2013, we purchased all of the outstanding shares of common stock of Talon Therapeutics, Inc. (“Talon”). Through the acquisition of Talon, we gained worldwide rights to MARQIBO, an FDA-approved drug that we believe complements our other hematology and oncology products. | |||||
The Talon purchase consideration comprised of (i) an aggregate upfront cash amount of $11.3 million, (ii) issuance of 3.0 million shares of our common stock, then equivalent to $26.3 million (based on a closing price of $8.77 per share on July 17, 2013), and (iii) the issuance of contingent value rights (“CVR”) initially valued at $6.5 million. | |||||
The CVR was valued using a valuation model that probability-weights expected outcomes (ranging from 50% to 100%) and discounts those amounts to their present value, using a discount rate of 25% (these represent unobservable inputs and are therefore classified as Level 3 inputs – see Note 2 (xiii)). The CVR has a maximum payout of $195.0 million if all sales and regulatory approval milestones are achieved, as summarized below: | |||||
• | $5.0 million upon the achievement of net sales of MARQIBO in excess of $30.0 million in any calendar year | ||||
• | $10.0 million upon the achievement of net sales of MARQIBO in excess of $60.0 million in any calendar year | ||||
• | $25.0 million upon the achievement of net sales of MARQIBO in excess of $100.0 million in any calendar year | ||||
• | $50.0 million upon the achievement of net sales of MARQIBO in excess of $200.0 million in any calendar year | ||||
• | $100.0 million upon the achievement of net sales of MARQIBO in excess of $400.0 million in any calendar year | ||||
• | $5.0 million upon receipt of marketing authorization from the FDA regarding Menadione Topical Lotion | ||||
Talon CVR Fair Value as of June 30, 2014 and December 31, 2013 | |||||
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 acquisition” in the accompanying Condensed Consolidated Statements of Operations. | |||||
Fair Value | |||||
of Talon | |||||
CVR | |||||
December 31, 2013 | $ | 4,329 | |||
Fair value adjustment for the six months ended June 30, 2014 | 1,367 | ||||
June 30, 2014 | $ | 5,696 | |||
(b) Acquisition of Rights to Captisol-Enabled® Melphalan | |||||
Overview of Acquisition of Rights to Captisol-Enabled® Melphalan | |||||
On March 8, 2013, we completed the acquisition of exclusive global development and commercialization rights to Captisol-enabled ®, propylene glycol-free MELPHALAN (“C-E MELPHALAN”) for use as a conditioning treatment prior to autologous stem cell transplant for patients with multiple myeloma from CyDex Pharmaceuticals, Inc. a wholly-owned subsidiary of Ligand Pharmaceuticals Incorporated (“Ligand”) for an initial license fee of $3.0 million (paid on April 1, 2013). Aggregate transaction costs were nominal for this acquisition. | |||||
We accounted for this transaction as a business combination (rather than as an asset acquisition), using the acquisition method of accounting. This requires that assets acquired and liabilities assumed be recognized on the balance sheet at their fair values, which involves our estimates of future cash flows and the application of appropriate discount rates as of the transaction date. | |||||
We are required to pay Ligand additional amounts up to an aggregate $66.0 million, upon the achievement of certain regulatory milestones and net sales thresholds (“Ligand Contingent Consideration”), and we also assumed full responsibility for its ongoing clinical and regulatory development program. We also must pay royalties in the range of 15% to 25% on our future net sales of licensed products in all territories. | |||||
Consideration Transferred | |||||
The acquisition-date fair value of the consideration transferred consisted of the following items: | |||||
Cash consideration | $ | 3,000 | |||
Ligand Contingent Consideration | 4,700 | ||||
Total purchase consideration | $ | 7,700 | |||
Fair Value Estimate of Asset Acquired and Liability Assumed | |||||
The total purchase consideration is allocated to the acquisition of the net tangible and intangible assets based on their estimated fair values as of the closing date. The allocation of the total purchase price to the net assets acquired is as follows: | |||||
IPR&D—Captisol-enabled®, propylene glycol-free MELPHALAN rights | $ | 7,700 | |||
IPR&D is an intangible asset that is classified as indefinite-lived until the completion or abandonment of the associated R&D effort, and is subject to impairment testing. C-E MELPHALAN IPR&D will be amortized over an estimated useful life to be determined at the date the project is complete. | |||||
We estimated the fair value of this IPR&D using the “income approach”. The income approach uses valuation techniques to convert future amounts to a single present amount (discounted). Our measurement is based on the value indicated by current market expectations about those future amounts. The fair value estimate took into account our estimates of future incremental earnings that may be achieved upon regulatory approval, promotion, and distribution associated with the rights, and included estimated cash flows of approximately 10 years and a discount rate of approximately 25%. | |||||
The fair value of the contingent consideration liability assumed was determined using the probability of success and the discounted cash flow method of the income approach, which assumes that FDA approval of C-E MELPHALAN will occur on or about December 31, 2015. Upon receipt of FDA approval, we will be obligated to make a milestone payment to Ligand. | |||||
Ligand Contingent Consideration Fair Value as of June 30, 2014 and December 31, 2013 | |||||
The Ligand Contingent Consideration fair value will continue to be evaluated on a quarterly basis. This liability is included within “acquisition-related contingent obligations” in the accompanying Condensed Consolidated Balance Sheets. 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 Ligand Contingent Consideration fair value are recognized within “change in fair value of contingent consideration related to acquisition” in the accompanying Condensed Consolidated Statements of Operations. | |||||
Fair Value of | |||||
Ligand | |||||
Contingent | |||||
Consideration | |||||
December 31, 2013 | $ | 4,000 | |||
Fair value adjustment for the six months ended June 30, 2014 | 300 | ||||
June 30, 2014 | $ | 4,300 | |||
Revolving_Line_of_Credit
Revolving Line of Credit | 6 Months Ended |
Jun. 30, 2014 | |
Debt Disclosure [Abstract] | ' |
Revolving Line of Credit | ' |
10. REVOLVING LINE OF CREDIT | |
We entered into a credit agreement on September 5, 2012 with Bank of America, N.A, as the administrative agent and Wells Fargo Bank, N.A, as an initial lender (the “Credit Agreement”). The Credit Agreement provided us with a committed $50.0 million revolving line of credit facility (the “Credit Facility”). The Credit Facility was repaid in full, then immediately terminated, on December 20, 2013 in connection with the sale and issuance of our 2018 Convertible Notes (see Note 11). | |
The Credit Facility bore interest, at our election, at a rate equal to the London Interbank Offer Rate (LIBOR), plus an applicable margin (2.75% to 4.25%, dependent on a defined liquidity ratio). An unused line fee was payable quarterly in an amount ranging from 0.38% to 0.63%. |
Convertible_Senior_Notes
Convertible Senior Notes | 6 Months Ended | ||||
Jun. 30, 2014 | |||||
Text Block [Abstract] | ' | ||||
Convertible Senior Notes | ' | ||||
11. CONVERTIBLE SENIOR NOTES | |||||
On December 17, 2013, we entered into an agreement for the sale of $120.0 million aggregate principal amount of 2.75% Convertible Senior Notes due December 2018 (the “2018 Convertible Notes”). The 2018 Convertible Notes are convertible into shares of our common stock at a conversion rate of 95 shares per $1,000 principal amount of the 2018 Convertible Notes, totaling 11.4 million common shares if fully converted. The in-the-money conversion price is equivalent to $10.53 per common share. The conversion rate and conversion price is subject to adjustment under certain limited circumstances. The 2018 Convertible Notes bear interest at a rate of 2.75% per year, payable semiannually in arrears on June 15 and December 15 of each year, beginning on June 15, 2014. The 2018 Convertible Notes will mature and become payable on December 15, 2018, subject to earlier conversion into common stock at the holders’ option. | |||||
The sale of the 2018 Convertible Notes closed on December 23, 2013 and our net proceeds were $115.4 million, after deducting banker and professional fees of $4.6 million. We used a portion of these net proceeds to simultaneously enter into “bought call” and “sold warrant” transactions with Royal Bank of Canada (collectively, the “Note Hedge”). We recorded the Note Hedge on a net cost basis of $13.1 million, as a reduction to “additional paid-in capital” in our accompanying Condensed Consolidated Balance Sheets. Under applicable GAAP, the Note Hedge transaction is not expected to be marked-to-market through earnings or comprehensive income in future reported periods. | |||||
We entered into Note Hedge transactions to reduce the potential dilution to our stockholders and/or offset any cash payments that we are required to make in excess of the principal amount, upon conversion of the 2018 Convertible Notes (in the event that the market price of our common stock is greater than the conversion price). The strike price of the “bought call” is equal to the conversion price and conversion rate of the 2018 Convertible Notes, matching the 11.4 million common shares the 2018 Convertible Notes may be converted into. The strike price of our “sold warrant” is $14.03 per share of our common stock, and is also for 11.4 million common shares. | |||||
As of June 30, 2014, the 2018 Convertible Notes could be converted into common stock. Prior to June 15, 2018, holders may convert all or a portion of their 2018 Convertible Notes only under the following circumstances: (1) during any fiscal quarter (and only during such fiscal quarter), if, for at least 20 trading days (whether or not consecutive) during the 30 consecutive trading day period ending on the last trading day of the immediately preceding fiscal quarter, the last reported sale price of our common stock on such trading day is greater than or equal to 130% of the applicable conversion price on such trading day; (2) during the five consecutive business day period immediately following any five consecutive trading day period in which, for each trading day of that measurement period, the trading price per $1,000 principal amount of 2018 Convertible Notes for such trading day was less than 98% of the product of (i) the last reported sale price of our common stock on such trading day and (ii) the applicable conversion rate on such trading day; (3) upon the occurrence of certain corporate transactions; and (4) at any time prior to our stockholders’ approval to settle the 2018 Convertible Notes in our common shares and/or cash. On and after June 15, 2018 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 at any time. | |||||
We initially may only settle conversions of the 2018 Convertible Notes by delivering shares of our common stock. However, if we obtain stockholder approval, we may, at our election, settle conversions of the 2018 Convertible Notes by paying or delivering, as the case may be, cash, shares of common stock, or a combination of cash and shares of common stock. | |||||
The carrying value of the 2018 Convertible Notes as of June 30, 2014 is summarized as follows: | |||||
Principal amount | $ | 120,000 | |||
(Less): Unamortized debt discount (amortized through December 2018) | (26,188 | ) | |||
June 30, 2014 | $ | 93,812 | |||
The following table sets forth the components of the “interest expense” recognized in the accompanying Condensed Consolidated Statements of Operations for the 2018 Convertible Notes for the six months ended June 30, 2014: | |||||
Contractual coupon interest expense | $ | 1,659 | |||
Amortization of debt issuance costs | 308 | ||||
Accretion of debt discount | 2,332 | ||||
Total | $ | 4,299 | |||
Effective interest rate | 8.59 | % | |||
Mundipharma_Agreement
Mundipharma Agreement | 6 Months Ended | ||||||||||||
Jun. 30, 2014 | |||||||||||||
Text Block [Abstract] | ' | ||||||||||||
Mundipharma Agreement | ' | ||||||||||||
12. MUNDIPHARMA AGREEMENT | |||||||||||||
As the result of our acquisition of Allos Therapeutics, Inc. on September 5, 2012 (through which we obtained distribution rights for FOLOTYN), we assumed its obligations under an active strategic collaboration agreement with a third-party, Mundipharma (the “Mundipharma Collaboration Agreement”). Under the Mundipharma Collaboration Agreement, we retained full commercialization rights for FOLOTYN in the U.S. and Canada, with Mundipharma having exclusive rights to commercialize FOLOTYN in all other countries in the world (the “Mundipharma Territories”). | |||||||||||||
On May 29, 2013, the Mundipharma Collaboration Agreement was amended and restated (the “Amended Munipharma Collaboration Agreement”), in order to modify: (i) the scope of the licensed territory, (ii) milestone payments, (iii) royalty rates, and (iv) development obligations. In connection with the Amended Munipharma Collaboration Agreement, we received a one-time $7.0 million payment from Mundipharma for certain research and development activities performed by us. | |||||||||||||
As a result of the Amended Mundipharma Collaboration Agreement, (a) Europe and Turkey were excluded from Mundipharma’s commercialization territory, (b) we may receive regulatory milestone payments of up to $16.0 million, and commercial progress and sales-dependent milestone payments of up to $107.0 million, (c) we will receive tiered double-digit royalties based on net sales of FOLOTYN within Mundipharma’s licensed territories, and (d) we and Mundipharma will bear our own FOLOTYN development costs. | |||||||||||||
We recorded the initial September 2012 fair value of the related drug development liability of $12.3 million, using the discounted cash flow method of the income approach. The fair value of this liability was determined to be $17.2 million as of June 30, 2014 (inclusive of the $7.0 million payment received from Mundipharma). This value is included in the current and long-term portions of “drug development liability” within the accompanying Condensed Consolidated Balance Sheets, and it includes our assumptions about personnel needed to perform these research and development activities, third party costs for projected clinical trial enrollment, and patient treatment-related follow up through approximately 2031. | |||||||||||||
We will assess this liability at each subsequent reporting date and record its adjustment through “research and development” expense in our Condensed Consolidated Statements of Operations. | |||||||||||||
Drug | Drug | Total Drug | |||||||||||
Development | Development | Development | |||||||||||
Liability, | Liability, | Liability – | |||||||||||
Current – | Long Term – | FOLOTYN | |||||||||||
FOLOTYN | FOLOTYN | ||||||||||||
Balance at December 31, 2013 | $ | 3,119 | $ | 14,623 | $ | 17,742 | |||||||
Transfer from long term to current | — | — | — | ||||||||||
(Less): Expenses incurred | — | (554 | ) | (554 | ) | ||||||||
Balance at June 30, 2014 | $ | 3,119 | $ | 14,069 | $ | 17,188 | |||||||
Commitments_and_Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2014 | |
Commitments And Contingencies Disclosure [Abstract] | ' |
Commitments and Contingencies | ' |
13. COMMITMENTS AND CONTINGENCIES | |
(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) Licensing Agreements, Co-Development Agreements, and Milestone Payments | |
Our drug candidates are being developed pursuant to license agreements that provide us with territory-specific rights to its manufacture, sublicense, and sale. We are generally responsible for all development costs, patent filings and maintenance costs, sales and marketing costs, and liability insurance costs. We are also obligated to make certain milestone payments to third parties upon the achievement of regulatory and sales milestones that are specified in these license agreements. We estimate and present a corresponding liability on our Condensed Consolidated Balance Sheets when amounts are probable and reasonably estimable. In addition, we are obligated to pay royalties based on our current and future net sales of in-licensed products. | |
Our most significant of these agreements are listed and summarized below: | |
(i) ZEVALIN U.S.: Licensing and development in the U.S. | |
In December 2008, we acquired rights to commercialize and develop ZEVALIN in the U.S. as the result of a transaction with a third-party, Cell Therapeutics, Inc. (“CTI”) through our wholly-owned subsidiary, RIT Oncology LLC (“RIT”), where we assumed certain agreements with various third parties related to ZEVALIN intellectual property related to its manufacture, use, and sale in the U.S. | |
In accordance with the terms of assumed contracts, we are required to meet specified payment obligations, including a milestone payment to Corixa Corporation of $5.0 million based on ZEVALIN sales in the U.S. (the “Corixa Liability”). This milestone has not yet been met, and $0.1 million for this potential milestone achievement is included within “acquisition-related contingent obligations” in our accompanying June 30, 2014 Condensed Consolidated Balance Sheet. Our U.S. net sales-based royalties are in the low to mid-single digits to Genentech, Inc. and mid-single digits to Corixa. | |
(ii) ZEVALIN Ex-U.S.: License and Asset Purchase Agreement with Bayer Pharma | |
On April 1, 2012, through our wholly-owned subsidiary, Spectrum Pharmaceuticals Cayman, L.P., we completed the acquisition of licensing rights to market ZEVALIN outside of the U.S. from Bayer Pharma AG (“Bayer”). | |
ZEVALIN is currently approved in more than 40 countries outside the U.S. for the treatment of B-cell non-Hodgkin lymphoma, including countries in Europe, Latin America and Asia. In consideration for the rights granted under the agreement, concurrent with the closing, we paid Bayer a one-time fee of €19.0 million, and we will pay Bayer royalties based on a mid-teen digits percentage of net sales of the licensed products in all territories worldwide, except the U.S. Unless earlier terminated, the term of the agreement continues until the expiration of the last-to-expire patent covering the sale of a licensed product in the relevant country, or 15 years from the date of first commercial sale of the licensed product in such country, whichever is longer. | |
(iii) FUSILEV: Amended and Restated 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. Pursuant to the license agreement with Merck, we obtained the exclusive license to use regulatory filings related to FUSILEV and a non-exclusive license under certain patents and know-how to develop, manufacture, use, and sell FUSILEV in the field of oncology in North America in return for royalties in the mid-single digits percentage of net sales. Merck is eligible to receive a $0.2 million payment from us upon the achievement of a FDA approval of an oral form of FUSILEV. This milestone has not yet been met, and no such value is included within “total liabilities” in our accompanying Condensed Consolidated Balance Sheets for its potential achievement. | |
(iv) FOLOTYN: License Agreement with Sloan-Kettering Institute, SRI International and Southern Research Institute | |
In December 2002, Allos entered into the FOLOTYN License Agreement with Sloan-Kettering Institute for Cancer Research, SRI International, and Southern Research Institute. As a result of Allos becoming our wholly owned subsidiary on September 5, 2012, we are bound by the FOLOTYN License Agreement under which we obtained exclusive worldwide rights to a portfolio of patents and patent applications related to FOLOTYN and its uses. Under the terms of the FOLOTYN License Agreement, we are required to fund all development programs and will have sole responsibility for all commercialization activities. In addition, we pay the licensors royalties based on worldwide graduated annual levels of net sales of FOLOTYN, or sublicense revenues arising from sublicensing the product, if and when such sales or sublicenses occur. 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. | |
(v) C-E MELPHALAN: License Agreement with Cydex Pharmaceuticals, Inc. | |
On March 8, 2013, we completed the acquisition of exclusive global development and commercialization rights to C-E MELPHALAN from Ligand (see Note 9(b)). We reported on April 23, 2014 that C-E MELPHALAN had met its primary endpoint in a pivotal trial for use as a conditioning treatment prior to autologous stem cell transplant for patients with multiple myeloma, and as a result, we intend to file a NDA with the FDA in the second half of 2014. | |
We assumed full responsibility for its ongoing clinical and regulatory development program. We are required to pay Ligand additional amounts of up to $66 million, upon achievement of certain regulatory milestones and net sales thresholds, which we have valued at $4.3 million and $4.0 million within “acquisition-related contingent obligations” in our accompanying Condensed Consolidated Statements of Operations as of June 30, 2014 and December 31, 2013, respectively. We will also pay royalties in the range of 15% to 25% on our net sales of licensed products in all territories. | |
(vi) MARQIBO: Agreement with Talon Therapeutics, Inc. | |
On July 17, 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, we issued the former Talon stockholders contingent value rights (“CVR”) that we have valued and presented on our accompanying Condensed Consolidated Balance Sheets as a $5.7 million and $4.3 million liability within “acquisition-related contingent obligations” as of June 30, 2014 and December 31, 2013, respectively. The CVR has a maximum payout of $195 million if all sales and regulatory approval milestones are achieved. | |
(vii) APAZIQUONE: In-License Agreement with Allergan, Inc. | |
In October 2008, we entered into an exclusive development and commercialization collaboration agreement with Allergan for APAZIQUONE. Pursuant to the terms of the agreement, Allergan paid us an up-front non-refundable fee of $41.5 million at closing (which we have amortized through revenue within “license fees and service revenue” in full as of December 31, 2013). | |
On January 29, 2013, we entered into a second amendment to the license, development, supply and distribution agreement with Allergan to amend the agreement and reacquire the rights originally licensed to Allergan in the U.S., Europe, and other territories in exchange for a tiered single-digit royalty on certain products containing APAZIQUONE, and relieved Allergan of its development and commercialization obligations. | |
As a result of this amendment to the agreement, Allergan has no remaining obligations to us. We will be obligated to pay Allergan a tiered single-digit royalty not to exceed mid-single digits based upon our net sales of certain products containing APAZIQUONE in specified territories. Additionally, we will be obligated to pay any royalties or other payments due to certain licensors of underlying intellectual property, as well as to provide indemnification of Allergan for claims arising from the manufacture, development, or commercialization of pharmaceutical products containing APAZIQUONE by us. | |
(viii) APAZIQUONE: 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 APAZIQUONE in Asia, except North and South Korea (the “Nippon Kayaku Territory”). In addition, Nippon Kayaku received exclusive rights to APAZIQUONE for the treatment of non-muscle invasive bladder cancer in Asia (other than North and South Korea), including Japan and China. Nippon Kayaku will conduct APAZIQUONE 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 APAZIQUONE in the Nippon Kayaku Territory. | |
Pursuant to the terms of this agreement, Nippon Kayaku paid us an upfront fee of $15.0 million (which we have amortized through revenue within “license fees and service revenue” in full as of December 31, 2013). Nippon Kayaku is also obligated to make additional payments to us based on the achievement of certain development, regulatory and commercialization milestones. Under the terms of the agreement, we are entitled to payment of $10 million and $126 million upon achievement of certain regulatory and commercialization milestones, respectively. Also, Nippon Kayaku has agreed to pay us royalties based on a percentage of net sales of the subject products in the defined territory in the mid-teen digits. | |
Our license agreement with Nippon Kayaku provides for payments to us upon the achievement of development milestones, such as the completion of clinical trials or regulatory submissions, approvals by health authorities, and commercial launches of drug candidates. Given the challenges inherent in developing and obtaining approval for drug products and in achieving commercial launches, there was substantial uncertainty whether any such milestones would be achieved at the time of execution of such license agreement. Such revenue will only be recognized if/when such milestones are achieved. | |
(ix) BELEODAQ: Licensing and Collaboration Agreement with TopoTarget | |
In February 2010, we entered into a licensing and collaboration agreement with TopoTarget A/S (“TopoTarget”), as amended in October 2013, for the development and commercialization of BELEODAQ. The agreement provides that we have the exclusive right to manufacture, develop, and commercialize BELEODAQ in North America and India, with an option for China. Pursuant to the terms of this agreement, we paid TopoTarget an upfront fee of $30.0 million in 2010. | |
Under continuing terms, all development, including studies, will be conducted under a joint development plan, which we will fund 70% of such costs, and TopoTarget will fund 30%. We have final decision-making authority for all developmental activities in North America and India (and China upon exercise of its option). TopoTarget has final decision-making authority for all developmental activities in all other jurisdictions. | |
In February 2014, upon FDA acceptance of our new drug application (NDA), we issued TopoTarget 1.0 million shares of our common stock, and made a $10.0 million milestone payment to them. The aggregate payout value of this first milestone was $17.8 million and is recognized within “research and development” of the accompanying Condensed Consolidated Statement of Operations for the six months ended June 30, 2014. | |
In July 2014, we received approval from the FDA for BELEODAQ’s use for injection for the treatment of PTCL, and as a result, we are obligated to TopoTarget for a second milestone payment of $25.0 million by November 2014. As of June 30, 2014, no provision for this milestone (given its timing after our June 30, 2014 balance sheet date), or any other remaining regulatory or sales-based milestone aggregating $278.0 million is included within “total liabilities” in our accompanying Condensed Consolidated Balance Sheets for potential achievement. | |
We will pay TopoTarget future royalties in the mid-teen digits based on net sales of BELEODAQ in the defined territory. The agreement will continue until the expiration of the last royalty payment period in the last country in the defined territory with certain provisions surviving, unless earlier terminated in accordance with its terms. | |
(x) SPI-2012: Co-Development and Commercialization Agreement with Hanmi Pharmaceutical Company | |
In January 2012, we entered into a co-development and commercialization agreement with Hanmi Pharmaceutical Company, (“Hanmi”), for SPI-2012, formerly known as “LAPS-GCSF”, a drug for the treatment of chemotherapy induced neutropenia based on Hanmi’s proprietary LAPSCOVERY™ Technology, at which time we paid Hanmi $1.0 million. Under the terms of the agreement, as amended in March 2014, we will share the expenses of this study, and we continue to have primary responsibility for the SPI-2012 development plan. If SPI-2012 is ultimately commercialized by us, we will have worldwide rights, except for Korea, China, and Japan upon our payment of agreed-upon fees to Hanmi. We will also be responsible for milestone payments related to SPI-2012 regulatory approvals and sales thresholds. | |
(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 (except for certain amounts accrued for within the accompanying Condensed Consolidated Financial Statements), and the contracted prices do not exceed their fair market value. | |
(e) Employment Agreement | |
We have entered into an employment agreement with our Chief Executive Officer under which cash compensation and benefits would become payable in the event of termination by us for any reason other than cause, his resignation for good reason, or upon a change in control of our Company. | |
(f) Deferred Compensation Plan | |
The Spectrum Pharmaceuticals, Inc. Deferred Compensation Plan (the “DC Plan”) is administered by the Compensation Committee of our Board of Directors and is intended to comply with the requirements of Section 409A of the Internal Revenue Code of 1986, as amended. | |
The DC Plan is maintained to provide deferred compensation benefits for a select group of our employees (the “DC Participants”). Under the DC Plan, we provide the DC Participants with the opportunity to make annual elections to defer up to a specified amount or percentage of their eligible cash compensation, and we have the option to make discretionary contributions. At June 30, 2014 and December 31, 2013, DC Plan deferrals and contributions totaling $4.5 million and $3.9 million, respectively, are included within “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 reviewed at least quarterly and adjusted to reflect the impact of any settlement negotiations, judicial and administrative rulings, advice of legal counsel, and other information and events pertaining to a particular case. Litigation is inherently unpredictable. Although the ultimate resolution of these various matters cannot be determined at this time, we do not believe that such matters, individually or in the aggregate, will have a material adverse effect on our consolidated results of operations, cash flows, or financial condition. | |
We are presently responding to Abbreviated New Drug Applications (“ANDAs”) filed by companies seeking to launch generic forms of FUSILEV and FOLOTYN, respectively, and to certain shareholder suits that purportedly stem from our March 12, 2013 press release, in which we announced anticipated changes in customer ordering patterns of FUSILEV. These complaints allege that, as a result of the March 12, 2013 press release, our stock price declined. | |
FUSILEV ANDA Litigation | |
On January 20, 2012, March 2, 2012, and June 18, 2014, respectively, we filed suit against Sandoz Inc. and Innopharma Inc., and Ben Venue Laboratories, Inc., respectively, following Paragraph IV certifications in connection with their filing separate ANDAs, to manufacture a generic version of FUSILEV. We filed the lawsuits in the U.S. District Court for the Districts of Nevada and Delaware seeking to enjoin the approval of their ANDAs plus recovery of our litigation fees and costs incurred in such matters. On December 9, 2013, three Mylan entities collaborating with Innopharma were joined to Innopharma case. While we believe our patent rights are strong, the ultimate outcome of these cases is uncertain. | |
FOLOTYN ANDA Litigation | |
On June 19, 2014, we filed a lawsuit against five parties resulting from Paragraph IV certifications in connection with four separate ANDAs to manufacture a generic version of FOLOTYN: (1) Teva Pharmaceuticals USA, Inc., (2) Sandoz Inc., (3) Fresenius Kabi USA, LLC, and (4) Dr. Reddy’s Laboratories, Ltd., and Dr. Reddy’s Laboratories, Inc. We filed the lawsuit in the U.S. District Court for the District of Delaware seeking to enjoin the approval of their ANDAs plus recovery of our litigation fees and costs. While we believe our patent rights are strong, the ultimate outcome of such action is uncertain. | |
Shareholder Litigation | |
John Perry v. Spectrum Pharmaceuticals, Inc. et al. (Filed March 14, 2013 in United States District Court, District of Nevada; Case Number 2:2013-cv-00433-LDG-CWH. This putative consolidated class action raises substantially identical claims and allegations against defendants Spectrum Pharmaceuticals, Inc., Dr. Rajesh C. Shrotriya, Brett L. Scott, and Joseph Kenneth Keller. The alleged class period is August 8, 2012 to March 12, 2013. The lawsuits allege a violation of Section 10(b) of the Securities Exchange Act of 1934 against all defendants and control person liability, as a violation of Section 20(b) of the Securities Exchange Act of 1934, against the individual defendants. The claims purportedly stem from the Company’s March 12, 2013 press release, in which it announced that it anticipated a change in ordering patterns of FUSILEV. The complaints allege that, as a result of the March 12, 2013 press release, the Company’s stock price declined. The complaints further allege that during the putative class period certain defendants made misleadingly optimistic statements about FUSILEV sales, which inflated the trading price of Company stock. The lawsuits seek relief in the form of monetary damages, costs and fees, and any other equitable or injunctive relief that the court deems appropriate. On March 21, 2014, the Court entered an order appointing Arkansas Teacher Retirement System as lead plaintiff. On May 20, 2014, Arkansas Teacher Retirement System filed a consolidated amended class action complaint. On July 18, 2014, we filed a motion to dismiss the consolidated amended class action complaint. | |
Timothy Fik v. Rajesh C. Shrotriya, et al. (Filed April 11, 2013 in United States District Court, District of Nevada; Case Number 2:2013-cv-00624-JCM-CWH); Christopher J. Watkins v. Rajesh C. Shrotriya, et al. (Filed April 22, 2013 in United States District Court, District of Nevada; Case Number 2:2013-cv-00684-JCM-VCF); and Stefan Muenchhagen v. Rajesh C. Shrotriya, et al. (Filed May 28, 2013 in United States District Court, District of Nevada; Case Number 2:2013-cv-00942-APG-PAL). These derivative complaints are brought by the respective purported shareholders on behalf of nominal plaintiff Spectrum against certain current and former directors and officers. The complaints generally allege breaches of fiduciary based on conduct relating to the events alleged in the consolidated Perry action. The complaints seek compensatory damages, corporate governance reforms, restitution and disgorgement of defendants’ alleged profits, and costs and fees. On May 15, 2013, the court entered a consolidation order staying the actions pending resolution of the federal securities class action. | |
Hardik Kakadia v. Rajesh C. Shrotriya, et al. (Filed April 23, 2013 in the Eighth Judicial District Court of the State of Nevada in and for Clark County; Case Number A-13-680643-B); and Joel Besner v. Rajesh C. Shrotriya, et al. (Filed May 31, 2013 in the Eighth Judicial District Court of the State of Nevada in and for Clark County; Case Number A-13-682668-C) (collectively the “State Derivative Actions”). These consolidated State Derivative Actions are brought by the respective purported shareholders on behalf of nominal plaintiff Spectrum Pharmaceuticals, Inc. and are substantially similar to the consolidated federal derivative actions. | |
(h) SEC Subpoena | |
On April 1, 2013, we received a subpoena from the SEC for documents pursuant to a formal order of investigation. The subpoena followed our March 12, 2013 announcement that we anticipated a change in customer ordering patterns of FUSILEV. We continue to cooperate with this SEC investigation, though we cannot predict its outcome, or the timing of resolution. |
Income_Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2014 | |
Income Tax Disclosure [Abstract] | ' |
Income Taxes | ' |
14. 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 benefit for income taxes of $1.2 million and $5.3 million for the six months ended June 30, 2014 and 2013, respectively. Our ETR differs from the U.S. federal statutory tax rate of 35% 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. In addition, in the six months ended June 30, 2014, we expensed approximately $1.2 million related to the correction of our prior year estimate of carryback of federal net operating losses and of credits ineligible for offset against federal income taxes. | |
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 excess tax benefits associated with share-based compensation to stockholders’ equity only when realized. When assessing whether excess tax benefits relating to share-based compensation have been realized, we follow the with-and-without approach, excluding any indirect effects of the excess tax deductions. Under this approach, excess tax benefits related to share-based compensation are not deemed to be realized until after the utilization of all other tax benefits available to us. We recognize the impact of a tax position in our financial statements only if that position is more likely than not of being 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. |
Subsequent_Event
Subsequent Event | 6 Months Ended |
Jun. 30, 2014 | |
Subsequent Events [Abstract] | ' |
Subsequent Event | ' |
15. SUBSEQUENT EVENT | |
FDA Approval of BELEODAQ | |
On July 3, 2014, the FDA granted us accelerated approval of BELEODAQ™ for injection for the treatment of patients with relapsed or refractory PTCL. As a result of this milestone achievement, we are obligated to pay TopoTarget $25.0 million by November 2014 (see Note 13(b)(ix)). Since this event occurred after our balance sheet date of June 30, 2014, no provision or corresponding intangible asset has been recorded to our accompanying Condensed Consolidated Financial Statements. |
Description_of_Business_Basis_1
Description of Business, Basis of Presentation, and Operating Segment (Policies) | 6 Months Ended | |||
Jun. 30, 2014 | ||||
Accounting Policies [Abstract] | ' | |||
Description of Business | ' | |||
(a) Description of Business | ||||
Spectrum Pharmaceuticals, Inc. and its wholly-owned subsidiaries (“Spectrum”, the “Company”, “we”, “our”, or “us”), is a biotechnology company with fully integrated commercial and drug development operations, with a primary focus in oncology and hematology. Our strategy is comprised of acquiring, developing, and marketing a diverse pipeline of late-stage clinical and commercial products. | ||||
We currently market five drugs for the following indications: | ||||
• | FUSILEV® injection for patients in the U.S. with advanced metastatic colorectal cancer and to counteract certain effects of methotrexate therapy; | |||
• | ZEVALIN® injection for patients in the U.S. and various international markets with follicular non-Hodgkin’s lymphoma; | |||
• | FOLOTYN® injection for patients in the U.S. with relapsed or refractory peripheral T-cell lymphoma (“PTCL”); | |||
• | MARQIBO® injection for patients in the U.S. with Philadelphia chromosome–negative acute lymphoblastic leukemia; and | |||
• | BELEODAQ™ injection for patients in the U.S. with relapsed or refractory PTCL. We did not launch this product until July 2014, and accordingly, no corresponding revenue is reported for any period presented in the accompanying Condensed Consolidated Financial Statements. | |||
We also have ongoing indication expansion studies with several of our marketed products, and a diversified pipeline of product candidates in advanced-stage Phase 2 and Phase 3 studies. Our integrated in-house scientific team, includes formulation development and medical research, as well as expertise in regulatory and clinical affairs, biostatistics, and data management. In the U.S., we have full commercial operations for the sales and marketing of our drug products, and leverage the expertise of our worldwide partners to assist us with international sales and product development. | ||||
Basis of Presentation | ' | |||
(b) Basis of Presentation | ||||
Interim Financial Statements | ||||
The interim financial data as of June 30, 2014 and 2013 is unaudited and is not necessarily indicative of the 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 and six months ended June 30, 2014 and 2013. Certain information and footnote disclosures normally included in annual financial statements prepared in accordance with generally accepted accounting principles in the United States of America (“GAAP”) have been condensed or omitted pursuant to U.S. Securities and Exchange Commission (“SEC”) rules and regulations relating to interim financial statements. 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, 2013, filed with the SEC on March 12, 2014. | ||||
Principles of Consolidation | ||||
The accompanying Condensed Consolidated Financial Statements include the financial position, results of operations, and cash flows of Spectrum and its subsidiaries, all of which are wholly-owned (except for SPC, as discussed below). All inter-company accounts and transactions among the consolidated entities have been eliminated in consolidation. | ||||
Variable Interest Entity | ||||
We own fifty-percent of Spectrum Pharma Canada (“SPC”), organized in Quebec, Canada in January 2008. SPC is a “variable interest entity” as defined under applicable GAAP. Certain of our drug clinical studies are conducted through this entity, and we are obligated to fund all of its costs and have the sole rights to any revenue derived from its operations. Since we carry the full risks and rewards of this entity, we meet the applicable GAAP 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 | ' | |||
(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 and six months ended June 30, 2014 and 2013, all of our revenue and related expenses were solely attributable to these activities. Substantially all of our long-lived assets are located in the U.S. | ||||
Revenue Recognition | ' | |||
(i) Revenue Recognition | ||||
(a) Product Sales: We sell our products to wholesalers and distributors. Our wholesalers and distributors in turn sell the products directly to end-users, such as clinics, hospitals, and private oncology-based practices. Revenue from product sales is recognized when title and risk of loss have transferred to our customer, and the following additional criteria are met: | ||||
-1 | appropriate evidence of a binding arrangement exists with our customer; | |||
-2 | price is substantially fixed and determinable; | |||
-3 | collection from our customer is reasonably assured; | |||
-4 | our customer’s obligation to pay us is not contingent on resale of the product; | |||
-5 | we do not have significant obligations for future performance to directly bring about the resale of our product; and | |||
-6 | we have a reasonable basis to estimate returns. | |||
Our gross revenue is reduced by our gross-to-net (“GTN”) estimates, resulting in our reported “Product sales, net” in the accompanying Condensed Consolidated Statements of Operations. We defer revenue recognition in full if/when these estimates are not reasonably determinable at the time of sale. Information from external sources is used to estimate GTN adjustments. Such information includes written and oral information obtained from our wholesalers with respect to their inventory levels and sell-through to end-users during the period. The inventory information received from wholesalers is a product of their recordkeeping process. Our GTN estimates reduce revenue in the same period that the related sale is recorded and include the following major categories: | ||||
Product Returns Allowances: Our FUSILEV and MARQIBO customers (and BELEODAQ customers, beginning in the third quarter of 2014) are typically permitted to return products within six months of its expiration date, subject to certain restocking fees and preauthorization requirements. Returns for ZEVALIN and FOLOTYN expirations are not contractually or customarily allowed. We estimate potential returns, based on several factors, including historical rates of return, customer and end-user ordering patterns, inventory held by distributors, and sell through data of distributor sales to end users. In general, returned product is not resold. | ||||
Government Chargebacks: Our products are subject to certain pricing limits under federal government programs. Qualifying entities purchase products through our distributors at the discounted price. Our distributors charge the difference between the list price and discounted price back to us, for which there may be significant lag time. Due to estimates inherent in determining the amount and volume of government chargebacks we will incur, the actual amount of government chargeback claims may be materially different from our estimates. | ||||
Discounts: Discounts for prompt payment are estimated based on the customer’s payment history and our current expectations for timing of customer payment. | ||||
Rebates: Rebates are estimated based on the customer’s actual purchase level during the quarterly or annual rebate purchase period, and the corresponding contractual rebate tier we expect the customer to achieve. | ||||
Medicaid Rebates: Our products are subject to state government-managed Medicaid programs whereby discounts and rebates are provided to participating state governments. Our calculations related to these rebate accruals require estimates, including estimates of customer mix, to determine which of our sales will be subject to rebates and the amount of such rebates. Our estimates are based on historical claims and forecasting techniques, as supplemented by management’s judgment for many factors, including changes in sales trends and product pricing. Due to estimates and assumptions inherent in determining the amount of our product sales that will be subject to Medicaid rebates, and the time lag in us receiving these rebate notices (generally several months after the sale is made), the actual amount of these claims may be materially different from our estimates. As a result, Medicaid rebate adjustments affecting revenue may be prospectively recorded and reported over several periods after we reported the initial sale. | ||||
Distribution, Data, and GPO Administrative Fees: Distribution, data, and GPO administrative fees are paid to authorized wholesalers and specialty distributors of our products (except U.S. sales of ZEVALIN). These fees are based on a percentage of such estimated net sales and are for various services, including: contract administration, inventory management, product sales reporting by customer, and product returns processing. | ||||
(b) License Fees: We recognize revenue for our licensing of intellectual property to third parties, based on the terms of each contractual agreement. In general, this results in periodic revenue recognition as the licensee has sales for which we are entitled to a royalty, or in certain instances we may receive a lump-sum payment from licensees, in which case, revenue is fully recognized in that period. | ||||
(c) Service Revenue: We receive fees under certain arrangements for our research and development services. These services are generally performed in connection with a collaboration agreement with another pharmaceutical company. Payment may be triggered by the successful completion of a phase of development, results from a clinical trial, and/or regulatory approval events. We recognize revenue when the corresponding milestone is achieved, or the revenue is otherwise earned through our on-going activities. | ||||
ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606) (“ASU 2014-09”), was issued in May 2014 for our mandatory adoption beginning January 1, 2017 (no early adoption is permitted under this new revenue recognition standard). ASU 2014-09 requires an entity to recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. To achieve this core principle, the guidance provides that an entity should apply the following steps: (1) identify the contract(s) with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when, or as, the entity satisfies a performance obligation. We continue to evaluate the impact of ASU 2014-09 to our current revenue recognition models for product sales, license fees, and service revenue, as described above. | ||||
Cash and Equivalents | ' | |||
(ii) Cash and Equivalents | ||||
Our cash and equivalents consist of bank deposits and highly liquid investments with original maturities of three months or less from the original purchase date. | ||||
Marketable Securities | ' | |||
(iii) Marketable Securities | ||||
Our marketable securities consist of our holdings in mutual funds and bank certificates of deposit. These are classified as available-for-sale, with any unrealized change in value reflected in “unrealized gain (loss) on securities” on the accompanying Condensed Consolidated Statements of Comprehensive Income (Loss). Realized gains and losses on available-for-sale securities are included in “other expense” on the accompanying Condensed Consolidated Statements of Operations. | ||||
Accounts Receivable | ' | |||
(iv) Accounts Receivable | ||||
Our accounts receivable are derived from our product sales, license fees, and service revenue, and do not bear interest. The allowance for doubtful accounts is management’s best estimate of the amount of probable credit losses in existing accounts receivable. Account balances are charged off against the allowance after appropriate collection efforts are exhausted. | ||||
Inventories | ' | |||
(v) Inventories | ||||
We value inventory at the lower of the actual cost to purchase or manufacture it, or its market value (i.e., its net realizable value). Cost is determined on the first-in, first-out method (FIFO). We regularly review inventory quantities in process and on hand, and when appropriate, record a provision for obsolete and excess inventory to reduce it to its net realizable value. | ||||
Direct and indirect manufacturing costs related to the production of inventory in anticipation of FDA approval are expensed through “research and development,” rather than capitalized. Upon FDA approval, these direct and indirect manufacturing costs are subsequently capitalized to inventory as incurred. | ||||
Property and Equipment | ' | |||
(vi) Property and Equipment | ||||
Our property and equipment is stated at cost and depreciated on a straight-line basis over its estimated useful lives. In the case of leasehold improvements, depreciation is over the shorter of the estimated useful life or remaining term of the lease. We evaluate the recoverability of long-lived assets (which includes property and equipment) whenever events or changes in circumstances in our business indicate that the asset’s carrying amount may not be recoverable through on-going operations. | ||||
Goodwill and Intangible Assets | ' | |||
(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 transactions. Goodwill has an indefinite useful life and is not amortized, but is instead tested for impairment on an annual basis, unless there are interim impairment indicators requiring earlier testing. We perform our annual evaluation as of October 1 each year. | ||||
We evaluate the recoverability of indefinite and definite lived intangible assets at least annually, or whenever events or changes in our business indicate that an intangible asset’s 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. | |||
Stock-Based Compensation | ' | |||
(viii) Stock-Based Compensation | ||||
We recognize stock-based compensation expense for employees and directors over the equity award vesting period, on a straight-line basis, and is net of an estimated forfeiture rate which is periodically updated. | ||||
We use the Black-Scholes option pricing model to determine the fair value of stock option grants with service conditions for vesting, and the Monte Carlo valuation model to value equity awards with combined market conditions and service conditions for vesting. These models require the use of highly subjective assumptions, including the volatility of our stock price and the probability of the achievement of market capitalization thresholds. | ||||
Foreign Currency Translation and Transactions | ' | |||
(ix) Foreign Currency Translation and Transactions | ||||
We translate the assets and liabilities of our foreign subsidiaries stated in local functional currencies to U.S. dollars at the rates of exchange in effect at the end of the period. Revenues and expenses are translated using rates of exchange in effect during the period. Gains and losses from the translation of financial statements denominated in the foreign functional currency are included as a separate component of “accumulated other comprehensive loss” in the Condensed Consolidated Balance Sheets. | ||||
We record foreign currency transactions, when denominated in something other than the respective functional currency of our applicable legal entity, at the exchange rate prevailing at the date of the transaction. Resulting unrealized and realized gains and losses are included in “other income (expense), net” within the Condensed Consolidated Statements of Operations. Foreign currency transaction gains and losses have not been significant for any period presented. | ||||
Basic and Diluted Net (Loss) Income per Share | ' | |||
(x) Basic and Diluted Net (Loss) Income per Share | ||||
We calculate basic and diluted net (loss) income per share using the weighted average number of common shares outstanding during the periods presented. In periods of a net loss, basic and diluted loss per share are the same. For the diluted earnings per share calculation, we adjust the weighted average number of common shares outstanding to include only dilutive stock options, warrants, and other common stock equivalents outstanding during the period. | ||||
Income Taxes | ' | |||
(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 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, such amounts would be included in “income tax benefit (expense)” within the Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) in the period the notice was received. | ||||
Research and Development Costs | ' | |||
(xii) Research and Development Costs | ||||
Our research and development costs are expensed as incurred. | ||||
Fair Value Measurements | ' | |||
(xiii) Fair Value Measurements | ||||
We determine measurement-date fair value based on the proceeds that would be received through the sale an asset, or that we would pay to settle or transfer a liability, in an orderly transaction between market participants. We utilize valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible. Fair value measurements are based on a three-tier hierarchy that prioritizes the inputs used to measure fair value. These tiers include the following: | ||||
Level 1: Quoted prices (unadjusted) in active markets for identical assets or liabilities that are publicly accessible at the measurement date. | ||||
Level 2: Observable prices that are based on inputs not quoted on active markets, but that are corroborated by market data. These inputs may include quoted prices for similar assets or liabilities or quoted market prices in markets that are not active to the general public. | ||||
Level 3: Unobservable inputs are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs. | ||||
“Cash and cash equivalents” within our accompanying Condensed Consolidated Balance Sheets include certificates of deposit and money market funds that are valued utilizing Level 2 inputs. “Marketable securities” consist of mutual funds that are also valued utilizing Level 2 inputs. | ||||
“Other assets” within our accompanying Condensed Consolidated Balance Sheets include equity securities that are valued using Level 1 inputs. | ||||
The fair value of our “drug development liability” within our accompanying Condensed Consolidated Balance Sheets was estimated using the discounted income approach model. The unobservable inputs (i.e., Level 3 inputs) in this valuation model that have the most significant effect on these liabilities include (i) estimates of research and development personnel costs needed to perform the research and development services, (ii) estimates of expected cash outflows to third parties for services and supplies over the expected period that the services will be performed, and (iii) an appropriate discount rate for these expenditures. These inputs are reviewed for reasonableness by management on at least on a quarterly basis. | ||||
“Acquisition-related contingent obligations” within our accompanying Condensed Consolidated Balance Sheets represent future amounts we may be required to pay in conjunction with various business combinations. See Note 9(a) for a discussion of contingent value rights granted as part of our acquisition of Talon, and Note 9(b) for the fair value of the liability associated with FDA approval of C-E MELPHALAN. These liabilities are valued using Level 3 inputs and include probabilities and assumptions related to the timing and likelihood of achievement of regulatory and sales milestones. |
Balance_Sheet_Account_Detail_T
Balance Sheet Account Detail (Tables) | 6 Months Ended | ||||||||||||||||||||||||||||
Jun. 30, 2014 | |||||||||||||||||||||||||||||
Text Block [Abstract] | ' | ||||||||||||||||||||||||||||
Summary of Cash and Cash Equivalents and Marketable Securities | ' | ||||||||||||||||||||||||||||
The following is a summary of our “cash and cash equivalents” and “marketable securities”: | |||||||||||||||||||||||||||||
Cost | Gross | Gross | Estimated | Cash and cash | Marketable Securities | ||||||||||||||||||||||||
Unrealized | Unrealized | fair | equivalents | ||||||||||||||||||||||||||
Gains | Losses | Value | Current | Long | |||||||||||||||||||||||||
Term | |||||||||||||||||||||||||||||
June 30, 2014 | |||||||||||||||||||||||||||||
Bank deposits | $ | 59,443 | $ | — | $ | — | $ | 59,443 | $ | 59,443 | $ | — | $ | — | |||||||||||||||
Money market funds | 72,962 | — | — | 72,962 | 72,962 | — | — | ||||||||||||||||||||||
Bank CDs | 245 | — | — | 245 | — | 245 | — | ||||||||||||||||||||||
Mutual funds | 3,061 | — | — | 3,061 | — | 3,061 | — | ||||||||||||||||||||||
Total cash and equivalents and marketable securities | $ | 135,711 | $ | — | $ | — | $ | 135,711 | $ | 132,405 | $ | 3,306 | $ | — | |||||||||||||||
December 31, 2013 | |||||||||||||||||||||||||||||
Bank deposits | $ | 55,911 | $ | — | $ | — | $ | 55,911 | $ | 55,911 | $ | — | $ | — | |||||||||||||||
Money market funds | 100,395 | — | — | 100,395 | 100,395 | — | — | ||||||||||||||||||||||
Bank CDs | 410 | — | — | 410 | — | 410 | — | ||||||||||||||||||||||
Mutual funds | 3,061 | — | — | 3,061 | — | 3,061 | — | ||||||||||||||||||||||
Total cash and equivalents and marketable securities | $ | 159,777 | $ | — | $ | — | $ | 159,777 | $ | 156,306 | $ | 3,471 | $ | — | |||||||||||||||
Schedule of Property and Equipment Net of Accumulated Depreciation | ' | ||||||||||||||||||||||||||||
“Property and equipment, net of accumulated depreciation” consist of the following: | |||||||||||||||||||||||||||||
June 30, | December 31, | ||||||||||||||||||||||||||||
2014 | 2013 | ||||||||||||||||||||||||||||
Computer hardware and software | $ | 3,258 | $ | 5,154 | |||||||||||||||||||||||||
Laboratory equipment | 648 | 1,063 | |||||||||||||||||||||||||||
Office furniture | 372 | 1,575 | |||||||||||||||||||||||||||
Leasehold improvements | 2,858 | 2,813 | |||||||||||||||||||||||||||
Property and equipment, at cost | 7,136 | 10,605 | |||||||||||||||||||||||||||
(Less): Accumulated depreciation | (5,729 | ) | (9,070 | ) | |||||||||||||||||||||||||
Property and equipment, net of accumulated depreciation | $ | 1,407 | $ | 1,535 | |||||||||||||||||||||||||
Components of Inventories | ' | ||||||||||||||||||||||||||||
“Inventories” consist of the following: | |||||||||||||||||||||||||||||
June 30, | December 31, | ||||||||||||||||||||||||||||
2014 | 2013 | ||||||||||||||||||||||||||||
Raw materials | $ | 2,092 | $ | 1,794 | |||||||||||||||||||||||||
Work-in-process | 2,095 | 3,312 | |||||||||||||||||||||||||||
Finished goods | 6,694 | 8,413 | |||||||||||||||||||||||||||
$ | 10,881 | $ | 13,519 | ||||||||||||||||||||||||||
Schedule of Prepaid Expenses and Other Current Assets | ' | ||||||||||||||||||||||||||||
“Prepaid expenses and other current assets” consist of the following: | |||||||||||||||||||||||||||||
June 30, | December 31, | ||||||||||||||||||||||||||||
2014 | 2013 | ||||||||||||||||||||||||||||
Prepaid operating expenses | $ | 3,166 | $ | 3,213 | |||||||||||||||||||||||||
Research and development supplies | 244 | — | |||||||||||||||||||||||||||
$ | 3,410 | $ | 3,213 | ||||||||||||||||||||||||||
Schedule of Other Receivables | ' | ||||||||||||||||||||||||||||
“Other receivables” consist of the (i) amounts we expect to be refunded from taxing authorities for our income taxes paid, relating to fiscal year 2012 and the (ii) amounts we expect to be reimbursed from certain of our product development partners for incurred drug development expenses. | |||||||||||||||||||||||||||||
June 30, | December 31, | ||||||||||||||||||||||||||||
2014 | 2013 | ||||||||||||||||||||||||||||
Income tax receivable | $ | 9,098 | $ | 7,539 | |||||||||||||||||||||||||
Product development expenses—reimbursement receivables | 2,704 | — | |||||||||||||||||||||||||||
$ | 11,802 | $ | 7,539 | ||||||||||||||||||||||||||
Components of Intangible Assets Net of Accumulated Amortization | ' | ||||||||||||||||||||||||||||
“Intangible assets, net of accumulated amortization” consist of the following: | |||||||||||||||||||||||||||||
June 30, 2014 | |||||||||||||||||||||||||||||
Historical | Accumulated | Foreign | Impairment | Net Amount | Full | Remaining | |||||||||||||||||||||||
Cost | Amortization | Currency | Amortization | Amortization | |||||||||||||||||||||||||
Translation | Period (years) | Period (years) | |||||||||||||||||||||||||||
MARQIBO IPR&D (NHL indication) | $ | 17,600 | $ | — | $ | — | $ | — | $ | 17,600 | n/a | n/a | |||||||||||||||||
C-E MELPHALAN IPR&D | 7,700 | — | — | — | 7,700 | n/a | n/a | ||||||||||||||||||||||
MARQIBO distribution rights | 26,900 | (2,366 | ) | — | — | 24,534 | 11 | 9.7 | |||||||||||||||||||||
FOLOTYN distribution rights | 118,400 | (15,308 | ) | — | — | 103,092 | 13 | 10.9 | |||||||||||||||||||||
ZEVALIN distribution rights – U.S. | 41,900 | (25,315 | ) | — | — | 16,585 | 10 | 4.5 | |||||||||||||||||||||
ZEVALIN distribution rights – Ex-U.S. | 23,490 | (6,804 | ) | 453 | — | 17,139 | 8 | 5.6 | |||||||||||||||||||||
FUSILEV distribution rights | 16,778 | (5,546 | ) | — | — | 11,232 | 11 | 7.7 | |||||||||||||||||||||
FOLOTYN out-license* | 27,900 | (5,024 | ) | — | (1,023 | ) | 21,853 | 10 | 8 | ||||||||||||||||||||
Total intangible assets | $ | 280,668 | $ | (60,363 | ) | $ | 453 | $ | (1,023 | ) | $ | 219,735 | |||||||||||||||||
* | On May 29, 2013, we amended our collaboration agreement with Mundipharma in order to modify the scope of their licensed territories and the respective development obligations. As a result of the amendment, Europe and Turkey were excluded from Mundipharma’s commercialization territory, and royalty and milestone rates were modified. The modification of our associated royalty and milestone rights constituted a change in the contractual provisions under which we measured our original acquired intangible asset (i.e., FOLOTYN rights). We determined that an impairment of the FOLOTYN out-license rights to Mundipharma of $1.0 million resulted from this amendment. | ||||||||||||||||||||||||||||
December 31, 2013 | |||||||||||||||||||||||||||||
Historical | Accumulated | Foreign | Impairment | Net Amount | |||||||||||||||||||||||||
Cost | Amortization | Currency | |||||||||||||||||||||||||||
Translation | |||||||||||||||||||||||||||||
MARQIBO IPR&D (NHL indication) | $ | 17,600 | $ | — | $ | — | $ | — | $ | 17,600 | |||||||||||||||||||
C-E MELPHALAN IPR&D | 7,700 | — | — | — | 7,700 | ||||||||||||||||||||||||
MARQIBO distribution rights (ALL indication) | 26,900 | (1,107 | ) | — | — | 25,793 | |||||||||||||||||||||||
FOLOTYN distribution rights | 118,400 | (10,587 | ) | — | — | 107,813 | |||||||||||||||||||||||
ZEVALIN distribution rights – U.S. | 41,900 | (23,455 | ) | — | — | 18,445 | |||||||||||||||||||||||
ZEVALIN distribution rights – Ex-U.S. | 23,490 | (5,343 | ) | 682 | — | 18,829 | |||||||||||||||||||||||
FUSILEV distribution rights | 16,778 | (4,821 | ) | — | — | 11,957 | |||||||||||||||||||||||
FOLOTYN out-license | 27,900 | (3,662 | ) | — | (1,023 | ) | 23,215 | ||||||||||||||||||||||
Total intangible assets | $ | 280,668 | $ | (48,975 | ) | $ | 682 | $ | (1,023 | ) | $ | 231,352 | |||||||||||||||||
Estimated Intangible Asset Amortization Expense | ' | ||||||||||||||||||||||||||||
Estimated intangible asset amortization expense (excluding incremental amortization from the reclassification of IPR&D to developed technology) for the remainder of 2014 and the five succeeding fiscal years and thereafter is as follows: | |||||||||||||||||||||||||||||
Years Ending December 31 | |||||||||||||||||||||||||||||
Remainder of 2014 | $ | 11,438 | |||||||||||||||||||||||||||
2015 | 22,877 | ||||||||||||||||||||||||||||
2016 | 22,877 | ||||||||||||||||||||||||||||
2017 | 22,877 | ||||||||||||||||||||||||||||
2018 | 22,722 | ||||||||||||||||||||||||||||
2019 | 19,157 | ||||||||||||||||||||||||||||
2020 and thereafter | 72,487 | ||||||||||||||||||||||||||||
$ | 194,435 | ||||||||||||||||||||||||||||
Schedule of Goodwill | ' | ||||||||||||||||||||||||||||
“Goodwill” is comprised of the following (by source): | |||||||||||||||||||||||||||||
June 30, | December 31, | ||||||||||||||||||||||||||||
2014 | 2013 | ||||||||||||||||||||||||||||
Acquisition of Talon | $ | 10,526 | $ | 10,526 | |||||||||||||||||||||||||
Acquisition of ZEVALIN Ex-U.S. distribution rights | 2,525 | 2,525 | |||||||||||||||||||||||||||
Acquisition of Allos | 5,346 | 5,346 | |||||||||||||||||||||||||||
Foreign currency exchange translation effects | 79 | 104 | |||||||||||||||||||||||||||
$ | 18,476 | $ | 18,501 | ||||||||||||||||||||||||||
Summary of Other Assets | ' | ||||||||||||||||||||||||||||
Other assets” are comprised of the following: | |||||||||||||||||||||||||||||
June 30, | December 31, | ||||||||||||||||||||||||||||
2014 | 2013 | ||||||||||||||||||||||||||||
Investments in equity securities | $ | 4,648 | $ | 3,593 | |||||||||||||||||||||||||
Supplies and other assets | 691 | — | |||||||||||||||||||||||||||
Deposits | 193 | 190 | |||||||||||||||||||||||||||
2018 Convertible Notes issuance costs | 3,124 | 3,432 | |||||||||||||||||||||||||||
Executive officer life insurance – cash surrender value | 6,541 | 5,362 | |||||||||||||||||||||||||||
$ | 15,197 | $ | 12,577 | ||||||||||||||||||||||||||
Schedule of Accounts Payable and Other Accrued Liabilities | ' | ||||||||||||||||||||||||||||
“Accounts payable and other accrued liabilities” are comprised of the following: | |||||||||||||||||||||||||||||
June 30, | December 31, | ||||||||||||||||||||||||||||
2014 | 2013 | ||||||||||||||||||||||||||||
Trade payables | $ | 7,620 | $ | 12,796 | |||||||||||||||||||||||||
Accrued research and development expenses | 3,915 | 6,433 | |||||||||||||||||||||||||||
Accrued selling, general and administrative expenses | 7,591 | 8,870 | |||||||||||||||||||||||||||
Accrued rebates | 34,842 | 28,893 | |||||||||||||||||||||||||||
Accrued product royalty | 3,599 | 9,498 | |||||||||||||||||||||||||||
Allowance for returns | 1,500 | 2,900 | |||||||||||||||||||||||||||
Accrued data and distribution fees | 2,934 | 2,430 | |||||||||||||||||||||||||||
Accrued GPO administrative fees | 2,684 | 2,327 | |||||||||||||||||||||||||||
Inventory management fee | 845 | 616 | |||||||||||||||||||||||||||
Allowance for chargebacks | 3,648 | 5,074 | |||||||||||||||||||||||||||
$ | 69,178 | $ | 79,837 | ||||||||||||||||||||||||||
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 specifically for GTN estimates (see Note 2(i)) are as follows: | |||||||||||||||||||||||||||||
Description | Rebates and | Data and | Prompt | Returns | |||||||||||||||||||||||||
Chargebacks | Distribution, | Pay | |||||||||||||||||||||||||||
GPO Fees, and | Discount | ||||||||||||||||||||||||||||
Inventory | |||||||||||||||||||||||||||||
Management | |||||||||||||||||||||||||||||
Fees | |||||||||||||||||||||||||||||
Balance as of December 31, 2012 | $ | 26,176 | $ | 14,149 | $ | 1,451 | $ | 5,056 | |||||||||||||||||||||
Add: provisions (recovery) | 63,609 | 19,067 | 183 | (2,034 | ) | ||||||||||||||||||||||||
(Less): credits or actual allowances | (55,818 | ) | (27,843 | ) | (1,317 | ) | (122 | ) | |||||||||||||||||||||
Balance as of December 31, 2013 | 33,967 | 5,373 | 317 | 2,900 | |||||||||||||||||||||||||
Add: provisions (recovery) | 34,721 | 9,416 | 5 | (1,265 | ) | ||||||||||||||||||||||||
(Less): credits or actual allowances | (30,198 | ) | (8,326 | ) | (281 | ) | (135 | ) | |||||||||||||||||||||
Balance as of June 30, 2014 | $ | 38,490 | $ | 6,463 | $ | 41 | $ | 1,500 | |||||||||||||||||||||
Summary of Other Long-Term Liabilities | ' | ||||||||||||||||||||||||||||
Other long-term liabilities are comprised of the following: | |||||||||||||||||||||||||||||
June 30, | December 31, | ||||||||||||||||||||||||||||
2014 | 2013 | ||||||||||||||||||||||||||||
Accrued executive deferred compensation | $ | 4,527 | $ | 3,949 | |||||||||||||||||||||||||
Deferred rent (non-current portion) | 451 | 366 | |||||||||||||||||||||||||||
Business acquisition liability | — | 298 | |||||||||||||||||||||||||||
Other tax liabilities | 731 | 1,352 | |||||||||||||||||||||||||||
$ | 5,709 | $ | 5,965 | ||||||||||||||||||||||||||
GrosstoNet_Product_Sales_Table
Gross-to-Net Product Sales (Tables) | 6 Months Ended | ||||||||||||||||
Jun. 30, 2014 | |||||||||||||||||
Text Block [Abstract] | ' | ||||||||||||||||
Reconciliation of Gross to Net Product Sales | ' | ||||||||||||||||
The below table presents a GTN product sales reconciliation for the accompanying Condensed Consolidated Statement of Operations: | |||||||||||||||||
Three months ended | Six months ended | ||||||||||||||||
June 30, | June 30, | ||||||||||||||||
2014 | 2013 | 2014 | 2013 | ||||||||||||||
Gross product sales | $ | 68,329 | $ | 57,522 | $ | 129,828 | $ | 100,494 | |||||||||
Rebates and chargebacks | (17,772 | ) | (20,365 | ) | (34,721 | ) | (31,083 | ) | |||||||||
Data, distribution and GPO administrative fees | (4,920 | ) | (5,704 | ) | (9,416 | ) | (10,046 | ) | |||||||||
Prompt pay discount | (2 | ) | (13 | ) | (5 | ) | (105 | ) | |||||||||
Product returns allowance | 1,220 | 773 | 1,265 | 2,299 | |||||||||||||
Product sales, net | $ | 46,855 | $ | 32,213 | $ | 86,951 | $ | 61,559 | |||||||||
Product_Sales_Net_by_Geographi1
Product Sales, Net by Geographic Region and Product Line (Tables) | 6 Months Ended | ||||||||||||||||||||||||||||||||
Jun. 30, 2014 | |||||||||||||||||||||||||||||||||
Text Block [Abstract] | ' | ||||||||||||||||||||||||||||||||
Schedule of Product Sales, Net by Geography | ' | ||||||||||||||||||||||||||||||||
The below table presents “product sales, net” by geography for the three and six months ended June 30, 2014 and 2013: | |||||||||||||||||||||||||||||||||
Three months ended June 30, | Six months ended June 30, | ||||||||||||||||||||||||||||||||
2014 | 2013 | 2014 | 2013 | ||||||||||||||||||||||||||||||
United States | $ | 44,541 | 95.1 | % | $ | 30,157 | 93.6 | % | $ | 81,998 | 94.3 | % | 57,091 | 92.7 | % | ||||||||||||||||||
International: | |||||||||||||||||||||||||||||||||
Europe | 796 | 1.7 | % | 602 | 1.9 | % | 1,836 | 2.1 | % | 1,631 | 2.6 | % | |||||||||||||||||||||
Asia Pacific | 1,518 | 3.2 | % | 1,454 | 4.5 | % | 3,117 | 3.6 | % | 2,837 | 4.6 | % | |||||||||||||||||||||
Total international | 2,314 | 4.9 | % | 2,056 | 6.4 | % | 4,953 | 5.7 | % | 4,468 | 7.3 | % | |||||||||||||||||||||
Product sales, net | $ | 46,855 | 100 | % | $ | 32,213 | 100 | % | $ | 86,951 | 100 | % | 61,559 | 100 | % | ||||||||||||||||||
Schedule of Product Sales, Net by Product Line | ' | ||||||||||||||||||||||||||||||||
The below table presents “product sales, net” by product line for the three and six months ended June 30, 2014 and 2013: | |||||||||||||||||||||||||||||||||
Three months ended June 30, | Six months ended June 30, | ||||||||||||||||||||||||||||||||
2014 | 2013 | 2014 | 2013 | ||||||||||||||||||||||||||||||
FUSILEV | $ | 26,554 | 56.7 | % | $ | 12,864 | 39.9 | % | $ | 48,747 | 56.1 | % | $ | 24,706 | 40.1 | % | |||||||||||||||||
FOLOTYN | 12,597 | 26.9 | % | 12,557 | 39 | % | 22,655 | 26.1 | % | 22,481 | 36.5 | % | |||||||||||||||||||||
ZEVALIN | 6,336 | 13.5 | % | 6,792 | 21.1 | % | 12,636 | 14.5 | % | 14,372 | 23.3 | % | |||||||||||||||||||||
MARQIBO | 1,368 | 2.9 | % | — | — | % | 2,913 | 3.4 | % | — | — | % | |||||||||||||||||||||
Product sales, net | $ | 46,855 | 100 | % | $ | 32,213 | 100 | % | $ | 86,951 | 100 | % | $ | 61,559 | 100 | % | |||||||||||||||||
StockBased_Compensation_Tables
Stock-Based Compensation (Tables) | 6 Months Ended | ||||||||||||||||
Jun. 30, 2014 | |||||||||||||||||
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | ' | ||||||||||||||||
Summary of Stock-Based Compensation Expense | ' | ||||||||||||||||
Stock-based compensation expense included within “operating costs and expenses” for the three and six months ended June 30, 2014 and 2013 was as follows: | |||||||||||||||||
Three months ended | Six months ended | ||||||||||||||||
June 30, | June 30, | ||||||||||||||||
2014 | 2013 | 2014 | 2013 | ||||||||||||||
Research and development | $ | 511 | $ | 485 | $ | 955 | $ | 1,159 | |||||||||
Selling, general and administrative | 2,163 | 2,439 | 4,570 | 4,512 | |||||||||||||
Total share-based compensation | $ | 2,674 | $ | 2,924 | $ | 5,525 | $ | 5,671 | |||||||||
Net_Loss_Per_Share_Tables
Net Loss Per Share (Tables) | 6 Months Ended | ||||||||||||||||
Jun. 30, 2014 | |||||||||||||||||
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 and six months ended June 30, 2014 and 2013: | |||||||||||||||||
Three months ended June 30, | Six months ended June 30, | ||||||||||||||||
2014 | 2013 | 2014 | 2013 | ||||||||||||||
Net loss | $ | (3,563 | ) | $ | (9,721 | ) | $ | (31,204 | ) | $ | (15,157 | ) | |||||
Weighted average shares – basic and diluted | 64,609,197 | 58,977,295 | 64,119,441 | 58,995,735 | |||||||||||||
Net loss per share – basic and diluted | $ | (0.06 | ) | $ | (0.16 | ) | $ | (0.49 | ) | $ | (0.26 | ) | |||||
Schedule of Securities Excluded from Calculation of Net Loss Per Share | ' | ||||||||||||||||
The below-listed outstanding securities were excluded from our calculation of net loss per share, (using the treasury stock and if-converted method, as applicable), because their impact would have been anti-dilutive due to net loss per share in the three and six months ended June 30, 2014 and 2013: | |||||||||||||||||
Three months ended June 30, | Six months ended June 30, | ||||||||||||||||
2014 | 2013 | 2014 | 2013 | ||||||||||||||
2018 Convertible Notes | 11,401,284 | — | 11,401,284 | — | |||||||||||||
Common stock options | 2,076,157 | 2,412,230 | 2,300,525 | 3,211,911 | |||||||||||||
Restricted stock awards | 1,021,825 | 1,102,654 | 1,021,825 | 1,102,654 | |||||||||||||
Common stock warrants | 111,601 | 115,249 | 129,512 | 173,031 | |||||||||||||
Preferred stock | 40,000 | 40,000 | 40,000 | 40,000 | |||||||||||||
Total | 14,650,867 | 3,670,133 | 14,893,146 | 4,527,596 | |||||||||||||
Fair_Value_Measurements_Tables
Fair Value Measurements (Tables) | 6 Months Ended | ||||||||||||||||
Jun. 30, 2014 | |||||||||||||||||
Fair Value Disclosures [Abstract] | ' | ||||||||||||||||
Summary of Asset and Liability Fair Values | ' | ||||||||||||||||
The below table 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 (as described within Note 2(xiii)): | |||||||||||||||||
June 30, 2014 | |||||||||||||||||
Fair Value Measurements | |||||||||||||||||
Level 1 | Level 2 | Level 3 | Total | ||||||||||||||
Assets: | |||||||||||||||||
Bank CDs | $ | — | $ | 245 | $ | — | $ | 245 | |||||||||
Money market currency funds | — | 72,962 | — | 72,962 | |||||||||||||
Mutual funds | — | 3,061 | — | 3,061 | |||||||||||||
Deferred compensation investments, including life insurance cash surrender value | — | 6,541 | — | 6,541 | |||||||||||||
Equity securities | 4,648 | — | — | 4,648 | |||||||||||||
$ | 4,648 | $ | 82,809 | $ | — | $ | 87,457 | ||||||||||
Liabilities: | |||||||||||||||||
Deferred executive compensation liability | — | 4,527 | — | 4,527 | |||||||||||||
Drug development liability | — | — | 17,188 | 17,188 | |||||||||||||
Ligand Contingent Consideration | — | — | 4,300 | 4,300 | |||||||||||||
Talon CVR | — | — | 5,696 | 5,696 | |||||||||||||
Corixa Liability | — | — | 62 | 62 | |||||||||||||
$ | — | $ | 4,527 | $ | 27,246 | $ | 31,773 | ||||||||||
December 31, 2013 | |||||||||||||||||
Fair Value Measurements | |||||||||||||||||
Level 1 | Level 2 | Level 3 | Total | ||||||||||||||
Assets: | |||||||||||||||||
Bank CDs | $ | — | $ | 410 | $ | — | $ | 410 | |||||||||
Money market currency funds | — | 100,395 | — | 100,395 | |||||||||||||
Mutual funds | — | 3,061 | — | 3,061 | |||||||||||||
Deferred compensation investments, including life insurance cash surrender value | — | 5,362 | — | 5,362 | |||||||||||||
Equity securities | 3,593 | — | — | 3,593 | |||||||||||||
$ | 3,593 | $ | 109,228 | $ | — | $ | 112,821 | ||||||||||
Liabilities: | |||||||||||||||||
Deferred executive compensation liability | — | 3,949 | — | 3,949 | |||||||||||||
Deferred development costs | — | — | 17,742 | 17,742 | |||||||||||||
Ligand Contingent Consideration | — | — | 4,000 | 4,000 | |||||||||||||
Talon CVR | — | — | 4,329 | 4,329 | |||||||||||||
$ | — | $ | 3,949 | $ | 26,071 | $ | 30,020 | ||||||||||
Fair Value Measurement Activity for Liabilities Utilize Level 3 Inputs | ' | ||||||||||||||||
The following summarizes the fair value measurement activity for our liabilities that utilize Level 3 inputs: | |||||||||||||||||
Fair Value Measurements of | |||||||||||||||||
Unobservable Inputs (Level 3) | |||||||||||||||||
Balance at December 31, 2012 | $ | 14,520 | |||||||||||||||
Transfers in (out) of Level 3 | — | ||||||||||||||||
Deferred development costs | 5,509 | ||||||||||||||||
Deferred payment contingency | (2,287 | ) | |||||||||||||||
Ligand Contingent Consideration | 4,000 | ||||||||||||||||
Talon CVR | 4,329 | ||||||||||||||||
Balance at December 31, 2013 | 26,071 | ||||||||||||||||
Transfers in (out) of Level 3 | — | ||||||||||||||||
Deferred development costs (see Note 12) | (554 | ) | |||||||||||||||
Ligand Contingent Consideration (see Note 9(b)) | 300 | ||||||||||||||||
Talon CVR (see Note 9(a)) | 1,367 | ||||||||||||||||
Corixa Liability (see Note 13(b)(i)) | 62 | ||||||||||||||||
Balance at June 30, 2014** | $ | 27,246 | |||||||||||||||
** | This amount is comprised of current and long-term portion of “drug development liability” and “acquisition-related contingent obligations” on our accompanying Condensed Consolidated Balance Sheets. |
Business_Combinations_and_Cont1
Business Combinations and Contingent Consideration (Tables) | 6 Months Ended | ||||
Jun. 30, 2014 | |||||
Talon Therapeutics, Inc. [Member] | ' | ||||
Change in Fair Value of Contingent Consideration Related to Acquisition | ' | ||||
Adjustments to CVR fair value are recognized within “change in fair value of contingent consideration related to acquisition” in the accompanying Condensed Consolidated Statements of Operations. | |||||
Fair Value | |||||
of Talon | |||||
CVR | |||||
December 31, 2013 | $ | 4,329 | |||
Fair value adjustment for the six months ended June 30, 2014 | 1,367 | ||||
June 30, 2014 | $ | 5,696 | |||
Acquisition-Date Fair Value of Consideration Transferred | ' | ||||
The acquisition-date fair value of the consideration transferred consisted of the following items: | |||||
Cash consideration | $ | 3,000 | |||
Ligand Contingent Consideration | 4,700 | ||||
Total purchase consideration | $ | 7,700 | |||
Melphalan license [Member] | ' | ||||
Change in Fair Value of Contingent Consideration Related to Acquisition | ' | ||||
Adjustments to Ligand Contingent Consideration fair value are recognized within “change in fair value of contingent consideration related to acquisition” in the accompanying Condensed Consolidated Statements of Operations. | |||||
Fair Value of | |||||
Ligand | |||||
Contingent | |||||
Consideration | |||||
December 31, 2013 | $ | 4,000 | |||
Fair value adjustment for the six months ended June 30, 2014 | 300 | ||||
June 30, 2014 | $ | 4,300 | |||
Summary of Allocation of Total Purchase Price to Net Assets Acquired | ' | ||||
The allocation of the total purchase price to the net assets acquired is as follows: | |||||
IPR&D—Captisol-enabled®, propylene glycol-free MELPHALAN rights | $ | 7,700 | |||
Convertible_Senior_Notes_Table
Convertible Senior Notes (Tables) | 6 Months Ended | ||||
Jun. 30, 2014 | |||||
Text Block [Abstract] | ' | ||||
Carrying Value of 2018 Convertible Notes | ' | ||||
The carrying value of the 2018 Convertible Notes as of June 30, 2014 is summarized as follows: | |||||
Principal amount | $ | 120,000 | |||
(Less): Unamortized debt discount (amortized through December 2018) | (26,188 | ) | |||
June 30, 2014 | $ | 93,812 | |||
Components of the Interest Expense Recognized | ' | ||||
The following table sets forth the components of the “interest expense” recognized in the accompanying Condensed Consolidated Statements of Operations for the 2018 Convertible Notes for the six months ended June 30, 2014: | |||||
Contractual coupon interest expense | $ | 1,659 | |||
Amortization of debt issuance costs | 308 | ||||
Accretion of debt discount | 2,332 | ||||
Total | $ | 4,299 | |||
Effective interest rate | 8.59 | % | |||
Mundipharma_Agreement_Tables
Mundipharma Agreement (Tables) | 6 Months Ended | ||||||||||||
Jun. 30, 2014 | |||||||||||||
Text Block [Abstract] | ' | ||||||||||||
Schedule of Drug Development Liability Adjustments | ' | ||||||||||||
We will assess this liability at each subsequent reporting date and record its adjustment through “research and development” expense in our Condensed Consolidated Statements of Operations. | |||||||||||||
Drug | Drug | Total Drug | |||||||||||
Development | Development | Development | |||||||||||
Liability, | Liability, | Liability – | |||||||||||
Current – | Long Term – | FOLOTYN | |||||||||||
FOLOTYN | FOLOTYN | ||||||||||||
Balance at December 31, 2013 | $ | 3,119 | $ | 14,623 | $ | 17,742 | |||||||
Transfer from long term to current | — | — | — | ||||||||||
(Less): Expenses incurred | — | (554 | ) | (554 | ) | ||||||||
Balance at June 30, 2014 | $ | 3,119 | $ | 14,069 | $ | 17,188 | |||||||
Description_of_Business_Basis_2
Description of Business, Basis of Presentation, and Operating Segment - Additional Information (Detail) | 6 Months Ended |
Jun. 30, 2014 | |
Segment | |
Segment Reporting Information [Line Items] | ' |
Number of reportable operating segment | 1 |
Spectrum Pharma Canada [Member] | ' |
Segment Reporting Information [Line Items] | ' |
Ownership interest, percentage | 50.00% |
Use_of_Estimates_and_Summary_o1
Use of Estimates and Summary of Significant Accounting Policies - Additional Information (Detail) | 6 Months Ended |
Jun. 30, 2014 | |
Accounting Policies [Abstract] | ' |
Number of months customers are allowed to return products | '6 months |
Cash and equivalents maturities period | '3 months |
Balance_Sheet_Account_Detail_S
Balance Sheet Account Detail - Summary of Cash and Cash Equivalents and Marketable Securities (Detail) (USD $) | Jun. 30, 2014 | Dec. 31, 2013 | Jun. 30, 2013 | Dec. 31, 2012 |
In Thousands, unless otherwise specified | ||||
Schedule of Investments [Line Items] | ' | ' | ' | ' |
Cash and cash equivalents, Marketable securities, Cost | $135,711 | $159,777 | ' | ' |
Cash and cash equivalents, Marketable securities, Gross Unrealized Gains | ' | ' | ' | ' |
Cash and cash equivalents, Marketable securities, Gross Unrealized Losses | ' | ' | ' | ' |
Cash and cash equivalents, Marketable securities, Estimated fair Value | 135,711 | 159,777 | ' | ' |
Cash and cash equivalents | 132,405 | 156,306 | 121,103 | 139,698 |
Marketable Security, Current | 3,306 | 3,471 | ' | ' |
Bank Deposits [Member] | ' | ' | ' | ' |
Schedule of Investments [Line Items] | ' | ' | ' | ' |
Bank deposits, Cost | 59,443 | 55,911 | ' | ' |
Bank deposits, Gross Unrealized Gains | ' | ' | ' | ' |
Bank deposits, Gross Unrealized Losses | ' | ' | ' | ' |
Bank deposits, Estimated fair Value | 59,443 | 55,911 | ' | ' |
Cash and cash equivalents | 59,443 | 55,911 | ' | ' |
Money market funds [Member] | ' | ' | ' | ' |
Schedule of Investments [Line Items] | ' | ' | ' | ' |
Marketable security, Amortized Cost | 72,962 | 100,395 | ' | ' |
Marketable security, Gross Unrealized Gains | ' | ' | ' | ' |
Marketable security, Gross Unrealized Losses | ' | ' | ' | ' |
Marketable security, Estimated fair Value | 72,962 | 100,395 | ' | ' |
Cash and cash equivalents | 72,962 | 100,395 | ' | ' |
Bank CDs [Member] | ' | ' | ' | ' |
Schedule of Investments [Line Items] | ' | ' | ' | ' |
Marketable security, Amortized Cost | 245 | 410 | ' | ' |
Marketable security, Gross Unrealized Gains | ' | ' | ' | ' |
Marketable security, Gross Unrealized Losses | ' | ' | ' | ' |
Marketable security, Estimated fair Value | 245 | 410 | ' | ' |
Marketable Security, Current | 245 | 410 | ' | ' |
Mutual funds [Member] | ' | ' | ' | ' |
Schedule of Investments [Line Items] | ' | ' | ' | ' |
Marketable security, Amortized Cost | 3,061 | 3,061 | ' | ' |
Marketable security, Gross Unrealized Gains | ' | ' | ' | ' |
Marketable security, Gross Unrealized Losses | ' | ' | ' | ' |
Marketable security, Estimated fair Value | 3,061 | 3,061 | ' | ' |
Marketable Security, Current | $3,061 | $3,061 | ' | ' |
Balance_Sheet_Account_Detail_A
Balance Sheet Account Detail - Additional Information (Detail) (USD $) | 6 Months Ended | ||
Jun. 30, 2014 | Jun. 30, 2013 | Dec. 31, 2013 | |
Schedule Of Investments In Marketable Securities [Line Items] | ' | ' | ' |
Securities in continuous unrealized loss position, period | 'Longer than one year. | ' | ' |
Depreciation expense | $700,000 | $700,000 | ' |
Property and equipment, at cost | 7,136,000 | ' | 10,605,000 |
(Less): Accumulated depreciation | -5,729,000 | ' | -9,070,000 |
Intangible asset amortization expense | 11,400,000 | 9,900,000 | ' |
Adjusted Property And Equipment [Member] | ' | ' | ' |
Schedule Of Investments In Marketable Securities [Line Items] | ' | ' | ' |
Property and equipment, at cost | 4,200,000 | ' | ' |
(Less): Accumulated depreciation | ($4,000,000) | ' | ' |
Balance_Sheet_Account_Detail_S1
Balance Sheet Account Detail - Schedule of Property and Equipment Net of Accumulated Depreciation (Detail) (USD $) | Jun. 30, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Property, Plant and Equipment [Line Items] | ' | ' |
Property and equipment, at cost | $7,136 | $10,605 |
(Less): Accumulated depreciation | -5,729 | -9,070 |
Property and equipment, net of accumulated depreciation | 1,407 | 1,535 |
Computer hardware and software [Member] | ' | ' |
Property, Plant and Equipment [Line Items] | ' | ' |
Property and equipment, at cost | 3,258 | 5,154 |
Laboratory equipment [Member] | ' | ' |
Property, Plant and Equipment [Line Items] | ' | ' |
Property and equipment, at cost | 648 | 1,063 |
Office furniture [Member] | ' | ' |
Property, Plant and Equipment [Line Items] | ' | ' |
Property and equipment, at cost | 372 | 1,575 |
Leasehold improvements [Member] | ' | ' |
Property, Plant and Equipment [Line Items] | ' | ' |
Property and equipment, at cost | $2,858 | $2,813 |
Balance_Sheet_Account_Detail_C
Balance Sheet Account Detail - Components of Inventories (Detail) (USD $) | Jun. 30, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Inventory Disclosure [Abstract] | ' | ' |
Raw materials | $2,092 | $1,794 |
Work-in-process | 2,095 | 3,312 |
Finished goods | 6,694 | 8,413 |
Inventories | $10,881 | $13,519 |
Balance_Sheet_Account_Detail_S2
Balance Sheet Account Detail - Schedule of Prepaid Expenses and Other Current Assets (Detail) (USD $) | Jun. 30, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Deferred Costs Capitalized Prepaid And Other Assets Disclosure [Abstract] | ' | ' |
Prepaid operating expenses | $3,166 | $3,213 |
Research and development supplies | 244 | ' |
Prepaid expenses and other current assets | $3,410 | $3,213 |
Balance_Sheet_Account_Detail_S3
Balance Sheet Account Detail - Schedule of Other Receivables (Detail) (USD $) | Jun. 30, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Receivables [Abstract] | ' | ' |
Income tax receivable | $9,098 | $7,539 |
Product development expenses-reimbursement receivables | 2,704 | ' |
Other receivables | $11,802 | $7,539 |
Balance_Sheet_Account_Detail_C1
Balance Sheet Account Detail - Components of Intangible Assets Net of Accumulated Amortization (Detail) (USD $) | 6 Months Ended | 12 Months Ended |
In Thousands, unless otherwise specified | Jun. 30, 2014 | Dec. 31, 2013 |
Product Rights [Line Items] | ' | ' |
Historical Cost | $280,668 | $280,668 |
Accumulated Amortization | -60,363 | -48,975 |
Foreign Currency Translation | 453 | 682 |
Impairment | -1,023 | -1,023 |
Net Amount | 219,735 | 231,352 |
MARQIBO IPR&D (NHL indication) [Member] | ' | ' |
Product Rights [Line Items] | ' | ' |
Historical Cost | 17,600 | 17,600 |
Accumulated Amortization | ' | ' |
Foreign Currency Translation | ' | ' |
Impairment | ' | ' |
Net Amount | 17,600 | 17,600 |
Full Amortization Period (years) | ' | ' |
Remaining Amortization Period (years) | ' | ' |
C-E MELPHALAN IPR&D [Member] | ' | ' |
Product Rights [Line Items] | ' | ' |
Historical Cost | 7,700 | 7,700 |
Accumulated Amortization | ' | ' |
Foreign Currency Translation | ' | ' |
Impairment | ' | ' |
Net Amount | 7,700 | 7,700 |
Full Amortization Period (years) | ' | ' |
Remaining Amortization Period (years) | ' | ' |
MARQIBO distribution rights (ALL indication) [Member] | ' | ' |
Product Rights [Line Items] | ' | ' |
Historical Cost | 26,900 | 26,900 |
Accumulated Amortization | -2,366 | -1,107 |
Foreign Currency Translation | ' | ' |
Impairment | ' | ' |
Net Amount | 24,534 | 25,793 |
Full Amortization Period (years) | '11 years | ' |
Remaining Amortization Period (years) | '9 years 8 months 12 days | ' |
FOLOTYN distribution rights [Member] | ' | ' |
Product Rights [Line Items] | ' | ' |
Historical Cost | 118,400 | 118,400 |
Accumulated Amortization | -15,308 | -10,587 |
Foreign Currency Translation | ' | ' |
Impairment | -1,023 | ' |
Net Amount | 103,092 | 107,813 |
Full Amortization Period (years) | '13 years | ' |
Remaining Amortization Period (years) | '10 years 10 months 24 days | ' |
ZEVALIN distribution rights [Member] | United States [Member] | ' | ' |
Product Rights [Line Items] | ' | ' |
Historical Cost | 41,900 | 41,900 |
Accumulated Amortization | -25,315 | -23,455 |
Foreign Currency Translation | ' | ' |
Impairment | ' | ' |
Net Amount | 16,585 | 18,445 |
Full Amortization Period (years) | '10 years | ' |
Remaining Amortization Period (years) | '4 years 6 months | ' |
ZEVALIN distribution rights [Member] | Ex-U.S. [Member] | ' | ' |
Product Rights [Line Items] | ' | ' |
Historical Cost | 23,490 | 23,490 |
Accumulated Amortization | -6,804 | -5,343 |
Foreign Currency Translation | 453 | 682 |
Impairment | ' | ' |
Net Amount | 17,139 | 18,829 |
Full Amortization Period (years) | '8 years | ' |
Remaining Amortization Period (years) | '5 years 7 months 6 days | ' |
FUSILEV distribution rights [Member] | ' | ' |
Product Rights [Line Items] | ' | ' |
Historical Cost | 16,778 | 16,778 |
Accumulated Amortization | -5,546 | -4,821 |
Foreign Currency Translation | ' | ' |
Impairment | ' | ' |
Net Amount | 11,232 | 11,957 |
Full Amortization Period (years) | '11 years | ' |
Remaining Amortization Period (years) | '7 years 8 months 12 days | ' |
FOLOTYN out-License [Member] | ' | ' |
Product Rights [Line Items] | ' | ' |
Historical Cost | 27,900 | 27,900 |
Accumulated Amortization | -5,024 | -3,662 |
Foreign Currency Translation | ' | ' |
Impairment | -1,023 | -1,023 |
Net Amount | $21,853 | $23,215 |
Full Amortization Period (years) | '10 years | ' |
Remaining Amortization Period (years) | '8 years | ' |
Balance_Sheet_Account_Detail_C2
Balance Sheet Account Detail - Components of Intangible Assets Net of Accumulated Amortization (Parenthetical) (Detail) (USD $) | 6 Months Ended | 12 Months Ended |
In Thousands, unless otherwise specified | Jun. 30, 2014 | Dec. 31, 2013 |
Product Rights [Line Items] | ' | ' |
Impairment | $1,023 | $1,023 |
FOLOTYN distribution rights [Member] | ' | ' |
Product Rights [Line Items] | ' | ' |
Impairment | $1,023 | ' |
Balance_Sheet_Account_Detail_E
Balance Sheet Account Detail - Estimated Intangible Asset Amortization Expense (Detail) (USD $) | Jun. 30, 2014 |
In Thousands, unless otherwise specified | |
Investment Holdings [Abstract] | ' |
Remainder of 2014 | $11,438 |
2015 | 22,877 |
2016 | 22,877 |
2017 | 22,877 |
2018 | 22,722 |
2019 | 19,157 |
2020 and thereafter | 72,487 |
Intangible Assets, Net Total | $194,435 |
Balance_Sheet_Account_Detail_S4
Balance Sheet Account Detail - Schedule of Goodwill (Detail) (USD $) | 6 Months Ended | 12 Months Ended |
In Thousands, unless otherwise specified | Jun. 30, 2014 | Dec. 31, 2013 |
Goodwill [Line Items] | ' | ' |
Foreign currency exchange translation effects | $79 | $104 |
Goodwill | 18,476 | 18,501 |
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_S5
Balance Sheet Account Detail - Summary of Other Assets (Detail) (USD $) | Jun. 30, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Deferred Costs Capitalized Prepaid And Other Assets Disclosure [Abstract] | ' | ' |
Investments in equity securities | $4,648 | $3,593 |
Supplies and other assets | 691 | ' |
Deposits | 193 | 190 |
2018 Convertible Notes issuance costs | 3,124 | 3,432 |
Executive officer life insurance - cash surrender value | 6,541 | 5,362 |
Other assets | $15,197 | $12,577 |
Balance_Sheet_Account_Detail_S6
Balance Sheet Account Detail - Schedule of Accounts Payable and Other Accrued Liabilities (Detail) (USD $) | Jun. 30, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Payables And Accruals [Abstract] | ' | ' |
Trade payables | $7,620 | $12,796 |
Accrued research and development expenses | 3,915 | 6,433 |
Accrued selling, general and administrative expenses | 7,591 | 8,870 |
Accrued rebates | 34,842 | 28,893 |
Accrued product royalty | 3,599 | 9,498 |
Allowance for returns | 1,500 | 2,900 |
Accrued data and distribution fees | 2,934 | 2,430 |
Accrued GPO administrative fees | 2,684 | 2,327 |
Inventory management fee | 845 | 616 |
Allowance for chargebacks | 3,648 | 5,074 |
Accounts payable and other accrued liabilities | $69,178 | $79,837 |
Balance_Sheet_Account_Detail_S7
Balance Sheet Account Detail - Schedule of Amounts Presented in Accounts Payable and Other Accrued Liabilities (Detail) (USD $) | 6 Months Ended | 12 Months Ended |
In Thousands, unless otherwise specified | Jun. 30, 2014 | Dec. 31, 2013 |
Rebates and Chargebacks [Member] | ' | ' |
Schedule of Investments [Line Items] | ' | ' |
Balance as of December 31, 2012 | $33,967 | $26,176 |
Add: provisions (recovery) | 34,721 | 63,609 |
(Less): credits or actual allowances | -30,198 | -55,818 |
Balance as of December 31, 2013 | 38,490 | 33,967 |
Data and Distribution, GPO Fees, and Inventory Management Fees [Member] | ' | ' |
Schedule of Investments [Line Items] | ' | ' |
Balance as of December 31, 2012 | 5,373 | 14,149 |
Add: provisions (recovery) | 9,416 | 19,067 |
(Less): credits or actual allowances | -8,326 | -27,843 |
Balance as of December 31, 2013 | 6,463 | 5,373 |
Prompt Pay Discount [Member] | ' | ' |
Schedule of Investments [Line Items] | ' | ' |
Balance as of December 31, 2012 | 317 | 1,451 |
Add: provisions (recovery) | 5 | 183 |
(Less): credits or actual allowances | -281 | -1,317 |
Balance as of December 31, 2013 | 41 | 317 |
Returns [Member] | ' | ' |
Schedule of Investments [Line Items] | ' | ' |
Balance as of December 31, 2012 | 2,900 | 5,056 |
Add: provisions (recovery) | -1,265 | -2,034 |
(Less): credits or actual allowances | -135 | -122 |
Balance as of December 31, 2013 | $1,500 | $2,900 |
Balance_Sheet_Account_Detail_S8
Balance Sheet Account Detail - Summary of Other Long-Term Liabilities (Detail) (USD $) | Jun. 30, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Other Liabilities Disclosure [Abstract] | ' | ' |
Accrued executive deferred compensation | $4,527 | $3,949 |
Deferred rent (non-current portion) | 451 | 366 |
Business acquisition liability | ' | 298 |
Other tax liabilities | 731 | 1,352 |
Other long-term liabilities | $5,709 | $5,965 |
GrosstoNet_Product_Sales_Recon
Gross-to-Net Product Sales - Reconciliation of Gross-to-Net Product Sales (Detail) (USD $) | 3 Months Ended | 6 Months Ended | ||
In Thousands, unless otherwise specified | Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 |
Sales Revenue Net [Abstract] | ' | ' | ' | ' |
Gross product sales | $68,329 | $57,522 | $129,828 | $100,494 |
Rebates and chargebacks | -17,772 | -20,365 | -34,721 | -31,083 |
Data, distribution and GPO administrative fees | -4,920 | -5,704 | -9,416 | -10,046 |
Prompt pay discount | -2 | -13 | -5 | -105 |
Product returns allowance | 1,220 | 773 | 1,265 | 2,299 |
Product sales, net | $46,855 | $32,213 | $86,951 | $61,559 |
Product_Sales_Net_by_Geographi2
Product Sales, Net by Geographic Region and Product Line - Schedule of Product Sales, Net by Geography (Detail) (USD $) | 3 Months Ended | 6 Months Ended | ||
In Thousands, unless otherwise specified | Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 |
Sales Information [Line Items] | ' | ' | ' | ' |
Product sales, net | $46,855 | $32,213 | $86,951 | $61,559 |
Percentage of product sales, net | 100.00% | 100.00% | 100.00% | 100.00% |
United States [Member] | ' | ' | ' | ' |
Sales Information [Line Items] | ' | ' | ' | ' |
Product sales, net | 44,541 | 30,157 | 81,998 | 57,091 |
Percentage of product sales, net | 95.10% | 93.60% | 94.30% | 92.70% |
Total International [Member] | ' | ' | ' | ' |
Sales Information [Line Items] | ' | ' | ' | ' |
Product sales, net | 2,314 | 2,056 | 4,953 | 4,468 |
Percentage of product sales, net | 4.90% | 6.40% | 5.70% | 7.30% |
Total International [Member] | Europe [Member] | ' | ' | ' | ' |
Sales Information [Line Items] | ' | ' | ' | ' |
Product sales, net | 796 | 602 | 1,836 | 1,631 |
Percentage of product sales, net | 1.70% | 1.90% | 2.10% | 2.60% |
Total International [Member] | Asia Pacific [Member] | ' | ' | ' | ' |
Sales Information [Line Items] | ' | ' | ' | ' |
Product sales, net | $1,518 | $1,454 | $3,117 | $2,837 |
Percentage of product sales, net | 3.20% | 4.50% | 3.60% | 4.60% |
Product_Sales_Net_by_Geographi3
Product Sales, Net by Geographic Region and Product Line - Schedule of Product Sales, Net by Product Line (Detail) (USD $) | 3 Months Ended | 6 Months Ended | ||
In Thousands, unless otherwise specified | Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 |
Sales Information [Line Items] | ' | ' | ' | ' |
Product sales, net | $46,855 | $32,213 | $86,951 | $61,559 |
Percentage of product sales, net | 100.00% | 100.00% | 100.00% | 100.00% |
FUSILEV [Member] | ' | ' | ' | ' |
Sales Information [Line Items] | ' | ' | ' | ' |
Product sales, net | 26,554 | 12,864 | 48,747 | 24,706 |
FOLOTYN [Member] | ' | ' | ' | ' |
Sales Information [Line Items] | ' | ' | ' | ' |
Product sales, net | 12,597 | 12,557 | 22,655 | 22,481 |
ZEVALIN [Member] | ' | ' | ' | ' |
Sales Information [Line Items] | ' | ' | ' | ' |
Product sales, net | 6,336 | 6,792 | 12,636 | 14,372 |
MARQIBO [Member] | ' | ' | ' | ' |
Sales Information [Line Items] | ' | ' | ' | ' |
Product sales, net | $1,368 | ' | $2,913 | ' |
Sales [Member] | ' | ' | ' | ' |
Sales Information [Line Items] | ' | ' | ' | ' |
Percentage of product sales, net | 100.00% | 100.00% | 100.00% | 100.00% |
Sales [Member] | FUSILEV [Member] | ' | ' | ' | ' |
Sales Information [Line Items] | ' | ' | ' | ' |
Percentage of product sales, net | 56.70% | 39.90% | 56.10% | 40.10% |
Sales [Member] | FOLOTYN [Member] | ' | ' | ' | ' |
Sales Information [Line Items] | ' | ' | ' | ' |
Percentage of product sales, net | 26.90% | 39.00% | 26.10% | 36.50% |
Sales [Member] | ZEVALIN [Member] | ' | ' | ' | ' |
Sales Information [Line Items] | ' | ' | ' | ' |
Percentage of product sales, net | 13.50% | 21.10% | 14.50% | 23.30% |
Sales [Member] | MARQIBO [Member] | ' | ' | ' | ' |
Sales Information [Line Items] | ' | ' | ' | ' |
Percentage of product sales, net | 2.90% | ' | 3.40% | ' |
StockBased_Compensation_Summar
Stock-Based Compensation - Summary of Stock-Based Compensation Expense (Detail) (USD $) | 3 Months Ended | 6 Months Ended | ||
In Thousands, unless otherwise specified | Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' | ' | ' |
Total share-based compensation | $2,674 | $2,924 | $5,525 | $5,671 |
Research and development [Member] | ' | ' | ' | ' |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' | ' | ' |
Total share-based compensation | 511 | 485 | 955 | 1,159 |
Selling, general and administrative [Member] | ' | ' | ' | ' |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' | ' | ' |
Total share-based compensation | $2,163 | $2,439 | $4,570 | $4,512 |
Net_Loss_Per_Share_Computation
Net Loss Per Share - Computation of Net Loss Per Share (Detail) (USD $) | 3 Months Ended | 6 Months Ended | ||
In Thousands, except Share data, unless otherwise specified | Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 |
Earnings Per Share [Abstract] | ' | ' | ' | ' |
Net loss | ($3,563) | ($9,721) | ($31,204) | ($15,157) |
Weighted average shares - basic and diluted | 64,609,197 | 58,977,295 | 64,119,441 | 58,995,735 |
Net loss per share - basic and diluted | ($0.06) | ($0.16) | ($0.49) | ($0.26) |
Net_Loss_Per_Share_Schedule_of
Net Loss Per Share - Schedule of Securities Excluded from Calculation of Net Loss Per Share (Detail) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ' | ' | ' | ' |
Anti-dilutive excluded from computation of earnings per share amount | 14,650,867 | 3,670,133 | 14,893,146 | 4,527,596 |
Preferred stock [Member] | ' | ' | ' | ' |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ' | ' | ' | ' |
Anti-dilutive excluded from computation of earnings per share amount | 40,000 | 40,000 | 40,000 | 40,000 |
Common stock warrants [Member] | ' | ' | ' | ' |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ' | ' | ' | ' |
Anti-dilutive excluded from computation of earnings per share amount | 111,601 | 115,249 | 129,512 | 173,031 |
2018 Convertible Notes [Member] | ' | ' | ' | ' |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ' | ' | ' | ' |
Anti-dilutive excluded from computation of earnings per share amount | 11,401,284 | ' | 11,401,284 | ' |
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 | 2,076,157 | 2,412,230 | 2,300,525 | 3,211,911 |
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 | 1,021,825 | 1,102,654 | 1,021,825 | 1,102,654 |
Fair_Value_Measurements_Summar
Fair Value Measurements - Summary of Asset and Liability Fair Values (Detail) (USD $) | Jun. 30, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Assets: | ' | ' |
Deferred compensation investments, including life insurance cash surrender value | $6,541 | $5,362 |
Total Assets | 87,457 | 112,821 |
Liabilities: | ' | ' |
Deferred executive compensation liability | 4,527 | 3,949 |
Drug development liability | 17,188 | ' |
Deferred development costs | ' | 17,742 |
Ligand Contingent Consideration | 4,300 | 4,000 |
Talon CVR | 5,696 | 4,329 |
Corixa Liability | 62 | ' |
Total Liabilities | 31,773 | 30,020 |
Bank CDs [Member] | ' | ' |
Assets: | ' | ' |
Marketable securities, fair value | 245 | 410 |
Money market funds [Member] | ' | ' |
Assets: | ' | ' |
Marketable securities, fair value | 72,962 | 100,395 |
Mutual funds [Member] | ' | ' |
Assets: | ' | ' |
Marketable securities, fair value | 3,061 | 3,061 |
Equity Securities [Member] | ' | ' |
Assets: | ' | ' |
Marketable securities, fair value | 4,648 | 3,593 |
Level 1 [Member] | ' | ' |
Assets: | ' | ' |
Total Assets | 4,648 | 3,593 |
Level 1 [Member] | Equity Securities [Member] | ' | ' |
Assets: | ' | ' |
Marketable securities, fair value | 4,648 | 3,593 |
Level 2 [Member] | ' | ' |
Assets: | ' | ' |
Deferred compensation investments, including life insurance cash surrender value | 6,541 | 5,362 |
Total Assets | 82,809 | 109,228 |
Liabilities: | ' | ' |
Deferred executive compensation liability | 4,527 | 3,949 |
Total Liabilities | 4,527 | 3,949 |
Level 2 [Member] | Bank CDs [Member] | ' | ' |
Assets: | ' | ' |
Marketable securities, fair value | 245 | 410 |
Level 2 [Member] | Money market funds [Member] | ' | ' |
Assets: | ' | ' |
Marketable securities, fair value | 72,962 | 100,395 |
Level 2 [Member] | Mutual funds [Member] | ' | ' |
Assets: | ' | ' |
Marketable securities, fair value | 3,061 | 3,061 |
Level 3 [Member] | ' | ' |
Liabilities: | ' | ' |
Drug development liability | 17,188 | ' |
Deferred development costs | ' | 17,742 |
Ligand Contingent Consideration | 4,300 | 4,000 |
Talon CVR | 5,696 | 4,329 |
Corixa Liability | 62 | ' |
Total Liabilities | $27,246 | $26,071 |
Fair_Value_Measurements_Fair_V
Fair Value Measurements - Fair Value Measurement Activity for Liabilities Utilize Level 3 Inputs (Detail) (USD $) | 6 Months Ended | 12 Months Ended |
In Thousands, unless otherwise specified | Jun. 30, 2014 | Dec. 31, 2013 |
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ' | ' |
Beginning Balance | $26,071 | $14,520 |
Transfers in (out) of Level 3 | ' | ' |
Ending Balance | 27,246 | 26,071 |
Deferred development costs [Member] | ' | ' |
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ' | ' |
Transfers in (out) of Level 3 | -554 | 5,509 |
Deferred payment contingency [Member] | ' | ' |
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ' | ' |
Transfers in (out) of Level 3 | ' | -2,287 |
Ligand Contingent Consideration [Member] | ' | ' |
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ' | ' |
Transfers in (out) of Level 3 | 300 | 4,000 |
Talon CVR [Member] | ' | ' |
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ' | ' |
Transfers in (out) of Level 3 | 1,367 | 4,329 |
Corixa Liability [Member] | ' | ' |
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ' | ' |
Transfers in (out) of Level 3 | $62 | ' |
Business_Combinations_and_Cont2
Business Combinations and Contingent Consideration - Additional Information (Detail) (USD $) | 6 Months Ended | 1 Months Ended | 6 Months Ended | 1 Months Ended | 1 Months Ended | 6 Months Ended | 6 Months Ended | ||||||||||
Share data in Millions, except Per Share data, unless otherwise specified | Jun. 30, 2014 | Jun. 30, 2013 | Jul. 17, 2013 | Jun. 30, 2014 | Jul. 17, 2013 | Jul. 17, 2013 | Jul. 17, 2013 | Jul. 17, 2013 | Jul. 17, 2013 | Jun. 30, 2014 | Jun. 30, 2014 | Jul. 17, 2013 | Jun. 30, 2014 | Jul. 13, 2013 | Jul. 17, 2013 | Jul. 17, 2013 | Jun. 30, 2014 |
Milestone Payments [Member] | Milestone Payments [Member] | Milestone Payment One [Member] | Milestone Payment Two [Member] | Milestone Payment Three [Member] | Milestone Payment Four [Member] | Menadione Topical Lotion [Member] | Minimum [Member] | Maximum [Member] | Talon Therapeutics, Inc. [Member] | Talon Therapeutics, Inc. [Member] | Talon Therapeutics, Inc. [Member] | Talon Therapeutics, Inc. [Member] | Talon Therapeutics, Inc. [Member] | In-process research and development [Member] | |||
Minimum [Member] | Maximum [Member] | ||||||||||||||||
Business Acquisition [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Additional shares business acquisition date | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 17-Jul-13 | ' | ' | ' | ' |
Cash consideration | ' | $3,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | $11,300,000 | ' | ' | ' | ' |
Shares issued in acquisition | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 3 | ' | ' | ' | ' | ' |
Common stock value, per share | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | $8.77 | ' | ' | ' | ' |
Common stock value assigned | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 26,300,000 | ' | ' | ' | ' | ' |
Estimated fair value of acquisition | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 6,500,000 | ' | ' | ' | ' | ' |
Contingent value rights future cash payments | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 195,000,000 | ' | 195,000,000 | ' | ' | ' |
Contingent value rights valuation description | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | '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 a discount rate of 25% (these represent unobservable inputs and are therefore classified as Level 3 inputs b see Note 2 (xiii)). | ' | ' | ' | ' |
Contingent value rights expected rate | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 50.00% | 100.00% | ' |
Contingent value rights discount rate | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 25.00% | ' | ' | ' | ' | ' |
Milestone payments methods | 'If all sales and regulatory approval milestones are achieved, as summarized below: b" $5.0 million upon the achievement of net sales of MARQIBO in excess of $30.0 million in any calendar year b" $10.0 million upon the achievement of net sales of MARQIBO in excess of $60.0 million in any calendar year b" $25.0 million upon the achievement of net sales of MARQIBO in excess of $100.0 million in any calendar year b" $50.0 million upon the achievement of net sales of MARQIBO in excess of $200.0 million in any calendar year b" $100.0 million upon the achievement of net sales of MARQIBO in excess of $400.0 million in any calendar year b" $5.0 million upon receipt of marketing authorization from the FDA regarding Menadione Topical Lotion | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Milestone net sales achievement | ' | ' | 5,000,000 | 66,000,000 | 10,000,000 | 25,000,000 | 50,000,000 | 100,000,000 | 5,000,000 | ' | ' | ' | ' | ' | ' | ' | ' |
Milestone net sales achievement | ' | ' | 30,000,000 | ' | 60,000,000 | 100,000,000 | 200,000,000 | 400,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' |
License fees received | $3,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Royalties payout percentage on our future net sales of licensed products | ' | ' | ' | ' | ' | ' | ' | ' | ' | 15.00% | 25.00% | ' | ' | ' | ' | ' | ' |
Estimated cash flow period | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | '10 years |
Estimated cash flow discount rate | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 25.00% |
Business_Combinations_and_Cont3
Business Combinations and Contingent Consideration - Change in Fair Value of Contingent Consideration Related to Acquisition (Detail) (USD $) | 6 Months Ended |
In Thousands, unless otherwise specified | Jun. 30, 2014 |
Talon Therapeutics, Inc. [Member] | ' |
Business Acquisition, Contingent Consideration [Line Items] | ' |
Fair value, Beginning Balance | $4,329 |
Fair value adjustment for the six months ended June 30, 2014 | 1,367 |
Fair value, Ending Balance | 5,696 |
Ligand Pharmaceuticals Inc [Member] | ' |
Business Acquisition, Contingent Consideration [Line Items] | ' |
Fair value, Beginning Balance | 4,000 |
Fair value adjustment for the six months ended June 30, 2014 | 300 |
Fair value, Ending Balance | $4,300 |
Business_Combinations_and_Cont4
Business Combinations and Contingent Consideration - Acquisition-Date Fair Value of Consideration Transferred (Detail) (USD $) | 6 Months Ended | |
In Thousands, unless otherwise specified | Jun. 30, 2013 | Jun. 30, 2014 |
Captisol-enabled, propylene glycol-free melphalan rights [Member] | ||
Business Acquisition [Line Items] | ' | ' |
Cash consideration | $3,000 | $3,000 |
Ligand Contingent Consideration | ' | 4,700 |
Total purchase consideration | ' | $7,700 |
Business_Combinations_and_Cont5
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], USD $) | Jun. 30, 2014 |
In Thousands, unless otherwise specified | |
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 |
Revolving_Line_of_Credit_Addit
Revolving Line of Credit - Additional Information (Detail) (USD $) | 6 Months Ended |
In Millions, unless otherwise specified | Jun. 30, 2014 |
Debt Disclosure [Abstract] | ' |
Credit agreement revolving line of credit facility | $50 |
Credit facility, minimum interest rate | 2.75% |
Credit facility, maximum interest rate | 4.25% |
Percentage of minimum amount of unused line fee | 0.38% |
Percentage of maximum amount of unused line fee | 0.63% |
Convertible_Senior_Notes_Addit
Convertible Senior Notes - Additional Information (Detail) (USD $) | Jun. 30, 2014 | Dec. 31, 2013 | Jun. 30, 2014 | Jun. 30, 2014 | Jun. 30, 2014 |
2.75% Convertible Senior Notes Due 2018 [Member] | 2.75% Convertible Senior Notes Due 2018 [Member] | 2.75% Convertible Senior Notes Due 2018 [Member] | |||
Minimum [Member] | Maximum [Member] | ||||
Debt Disclosure [Line Items] | ' | ' | ' | ' | ' |
Sale of convertible notes, principal amount | ' | ' | $120,000,000 | ' | ' |
Conversion rate, shares | ' | ' | 95 | ' | ' |
Conversion rate, price per share | ' | ' | $1,000 | ' | ' |
Common shares converted value | ' | ' | 11,400,000 | ' | ' |
Money conversion price per share | ' | ' | $10.53 | ' | ' |
Interest rate | ' | ' | 2.75% | ' | ' |
Convertible senior notes maturity date | ' | ' | 15-Dec-18 | ' | ' |
Net proceeds from convertible notes | ' | ' | 115,400,000 | ' | ' |
Professional fee | ' | ' | 4,600,000 | ' | ' |
Additional paid-in capital | 532,554,000 | 518,144,000 | 13,100,000 | ' | ' |
Strike price per share | ' | ' | $14.03 | ' | ' |
Common shares sold | 66,000 | 64,000 | 11,400,000 | ' | ' |
Debt convertible trading days | ' | ' | ' | '20 days | ' |
Debt convertible consecutive trading days | ' | ' | ' | '5 days | '30 days |
Threshold percentage of conversion price | ' | ' | 130.00% | ' | ' |
Convertible senior notes trading price | ' | ' | $1,000 | ' | ' |
Percentage of product of last reported sale price of common stock | ' | ' | 98.00% | ' | ' |
Convertible senior notes conversion description | ' | ' | 'Prior to June 15, 2018, holders may convert all or a portion of their 2018 Convertible Notes only under the following circumstances: (1) during any fiscal quarter (and only during such fiscal quarter), if, for at least 20 trading days (whether or not consecutive) during the 30 consecutive trading day period ending on the last trading day of the immediately preceding fiscal quarter, the last reported sale price of our common stock on such trading day is greater than or equal to 130% of the applicable conversion price on such trading day; (2) during the five consecutive business day period immediately following any five consecutive trading day period in which, for each trading day of that measurement period, the trading price per $1,000 principal amount of 2018 Convertible Notes for such trading day was less than 98% of the product of (i) the last reported sale price of our common stock on such trading day and (ii) the applicable conversion rate on such trading day; (3) upon the occurrence of certain corporate transactions; and (4) at any time prior to our stockholdersb approval to settle the 2018 Convertible Notes in our common shares and/or cash. On and after June 15, 2018 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 at any time. | ' | ' |
Convertible_Senior_Notes_Carry
Convertible Senior Notes - Carrying Value of 2018 Convertible Notes (Detail) (2018 Convertible Notes [Member], USD $) | Jun. 30, 2014 |
In Thousands, unless otherwise specified | |
2018 Convertible Notes [Member] | ' |
Debt Instrument [Line Items] | ' |
Principal amount | $120,000 |
(Less): Unamortized debt discount (amortized through December 2018) | -26,188 |
June 30, 2014 carrying value | $93,812 |
Convertible_Senior_Notes_Compo
Convertible Senior Notes - Components of the Interest Expense Recognized (Detail) (USD $) | 6 Months Ended |
In Thousands, unless otherwise specified | Jun. 30, 2014 |
Equity Method Investments And Cost Method Investments [Abstract] | ' |
Contractual coupon interest expense | $1,659 |
Amortization of debt issuance costs | 308 |
Accretion of debt discount | 2,332 |
Total | $4,299 |
Effective interest rate | 8.59% |
Mundipharma_Agreement_Addition
Mundipharma Agreement - Additional Information (Detail) (USD $) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 | Sep. 30, 2012 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ' | ' | ' | ' | ' |
Company determined development payment | $48,251,000 | $45,761,000 | $112,789,000 | $90,885,000 | ' |
Deferred development cost | ' | ' | ' | ' | 12,300,000 |
Maximum [Member] | Regulatory [Member] | ' | ' | ' | ' | ' |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ' | ' | ' | ' | ' |
Potential milestone payments | ' | ' | 16,000,000 | ' | ' |
Maximum [Member] | Commercial progress and sales-dependent [Member] | ' | ' | ' | ' | ' |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ' | ' | ' | ' | ' |
Potential milestone payments | ' | ' | 107,000,000 | ' | ' |
Mundipharma [Member] | ' | ' | ' | ' | ' |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ' | ' | ' | ' | ' |
Company determined development payment | ' | ' | 7,000,000 | ' | ' |
Development cost liability | $17,200,000 | ' | $17,200,000 | ' | ' |
Mundipharma_Agreement_Schedule
Mundipharma Agreement - Schedule of Drug Development Liability Adjustments (Detail) (USD $) | Jun. 30, 2014 | Dec. 31, 2013 | Jun. 30, 2014 | Jun. 30, 2014 | Jun. 30, 2014 |
In Thousands, unless otherwise specified | FOLOTYN [Member] | FOLOTYN [Member] | FOLOTYN [Member] | ||
Drug Development Liability Current [Member] | Drug Development Liability Long Term [Member] | ||||
Schedule Of Accrued Liabilities [Line Items] | ' | ' | ' | ' | ' |
Beginning Balance | $3,119 | $3,119 | $17,742 | $3,119 | $14,623 |
Transfer from long term to current | ' | ' | 0 | 0 | 0 |
(Less): Expenses incurred | ' | ' | -554 | ' | -554 |
Ending Balance | $3,119 | $3,119 | $17,188 | $3,119 | $14,069 |
Commitments_and_Contingencies_
Commitments and Contingencies - Additional Information (Detail) | 6 Months Ended | 6 Months Ended | 1 Months Ended | 6 Months Ended | 6 Months Ended | 6 Months Ended | 1 Months Ended | 6 Months Ended | 1 Months Ended | 6 Months Ended | ||||||||||||
Share data in Millions, unless otherwise specified | Jun. 30, 2014 | Dec. 31, 2013 | 31-May-06 | Jun. 30, 2014 | Jun. 30, 2014 | Jun. 30, 2014 | Apr. 30, 2012 | Jun. 30, 2014 | Jun. 30, 2014 | Dec. 31, 2013 | Jul. 17, 2013 | Jul. 13, 2013 | Jun. 30, 2014 | Jun. 30, 2014 | Jun. 30, 2014 | Jun. 30, 2014 | Dec. 31, 2013 | Jun. 30, 2014 | Oct. 31, 2008 | Jun. 30, 2014 | Feb. 28, 2010 | Jun. 30, 2014 |
USD ($) | USD ($) | USD ($) | Nevada [Member] | California [Member] | ZEVALIN [Member] | ZEVALIN [Member] | ZEVALIN [Member] | Talon Therapeutics, Inc. [Member] | Talon Therapeutics, Inc. [Member] | Talon Therapeutics, Inc. [Member] | Talon Therapeutics, Inc. [Member] | FOLOTYN [Member] | Minimum [Member] | Minimum [Member] | Maximum [Member] | Maximum [Member] | Maximum [Member] | Allergan [Member] | Nippon Kayaku [Member] | TopoTarget [Member] | TopoTarget [Member] | |
Principal executive office [Member] | Research and development facility [Member] | USD ($) | Licensing Agreements [Member] | Licensing Agreements [Member] | USD ($) | USD ($) | USD ($) | USD ($) | FOLOTYN [Member] | USD ($) | USD ($) | FOLOTYN [Member] | USD ($) | USD ($) | USD ($) | USD ($) | ||||||
EUR (€) | Country | USD ($) | USD ($) | |||||||||||||||||||
Long-term Purchase Commitment [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Facility lease, non-cancelable operating lease expiring date | ' | ' | ' | 30-Apr-19 | 31-May-19 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Milestone payments | ' | ' | ' | ' | ' | $5,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Potential milestone achievement | 100,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 278,000,000 |
Minimum number of countries outside U.S. approved ZEVALIN for treatment | ' | ' | ' | ' | ' | ' | ' | 40 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Fees paid to Bayer for acquiring licensing rights | ' | ' | ' | ' | ' | ' | 19,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Amount receivable on approval of oral form of FUSILEV | ' | ' | 200,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Percentage of royalty on annual worldwide sales under condition one | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 8.00% | 15.00% | ' | 25.00% | ' | ' | ' | ' | ' | ' |
Percentage of royalty on annual worldwide sales under condition two | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 9.00% | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Percentage of royalty on annual worldwide sales under condition three | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 11.00% | ' | ' | ' | ' | ' | ' | ' | ' | ' |
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 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 150,000,000 | ' | ' | 300,000,000 | ' | ' | ' | ' |
Amount of annual worldwide sales on which royalty is payable under condition three | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 300,000,000 | ' | ' | ' | ' | ' | ' | ' |
Additional license fees | 66,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Percentage of royalties on net sale of licensed products | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 15.00% | ' | 25.00% | ' | ' | ' | ' | ' | ' |
Acquisition-related contingent obligations | 10,058,000 | 8,329,000 | ' | ' | ' | ' | ' | ' | 5,700,000 | 4,300,000 | ' | ' | ' | ' | ' | 4,300,000 | 4,000,000 | ' | ' | ' | ' | ' |
Contingent value rights future cash payments | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 195,000,000 | 195,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Up-front non-refundable payment | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 41,500,000 | ' | ' | ' |
Upfront fee | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 15,000,000 | ' | ' |
Payment related to agreement | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 10,000,000 | ' | ' |
Payment on achievement of commercialization milestones | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 126,000,000 | ' | ' |
Upfront fee | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 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 | ' |
Shares of common stock, issued | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 1 | ' |
Aggregate payout value | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 17,800,000 |
Second milestone payment | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 25,000,000 |
Consideration paid for the rights granted | 1,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Deferrals and contributions | $4,500,000 | $3,900,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Income_Taxes_Additional_Inform
Income Taxes - Additional Information (Detail) (USD $) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 | |
Income Tax Disclosure [Abstract] | ' | ' | ' | ' |
Benefit (provision) for income taxes | $1,301,000 | $2,971,000 | $1,223,000 | $5,310,000 |
U.S. federal statutory tax rate | ' | ' | 35.00% | ' |
Expense related to prior year federal net operating losses | ' | ' | $1,200,000 | ' |
Subsequent_Event_Additional_In
Subsequent Event - Additional Information (Detail) (Subsequent Event [Member], USD $) | 0 Months Ended | |
Jul. 03, 2014 | Jul. 03, 2014 | |
Subsequent Event [Member] | ' | ' |
Subsequent Event [Line Items] | ' | ' |
Potential future milestone payment | ' | $25,000,000 |
Provision on intangible asset | $0 | ' |