Document_and_Entity_Informatio
Document and Entity Information | 9 Months Ended | |
Sep. 30, 2013 | Nov. 14, 2013 | |
Document And Entity Information [Abstract] | ' | ' |
Document Type | '10-Q | ' |
Amendment Flag | 'false | ' |
Document Period End Date | 30-Sep-13 | ' |
Document Fiscal Year Focus | '2013 | ' |
Document Fiscal Period Focus | 'Q3 | ' |
Trading Symbol | 'SPPI | ' |
Entity Registrant Name | 'SPECTRUM PHARMACEUTICALS INC | ' |
Entity Central Index Key | '0000831547 | ' |
Current Fiscal Year End Date | '--12-31 | ' |
Entity Filer Category | 'Large Accelerated Filer | ' |
Entity Common Stock, Shares Outstanding | ' | 63,879,714 |
Condensed_Consolidated_Balance
Condensed Consolidated Balance Sheets (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
In Thousands, unless otherwise specified | ||
Current Assets: | ' | ' |
Cash and equivalents | $71,974 | $139,698 |
Marketable securities | 3,312 | 3,310 |
Accounts receivable, net of allowance for doubtful accounts of $254 and $228, respectively | 54,923 | 92,169 |
Inventories, net | 14,642 | 14,478 |
Prepaid expenses and other current assets | 4,852 | 2,745 |
Deferred tax asset | 3,824 | 12,473 |
Total current assets | 153,527 | 264,873 |
Property and equipment, net | 1,741 | 2,548 |
Intangible assets, net | 236,626 | 200,234 |
Goodwill | 7,900 | 7,279 |
Other assets | 8,614 | 6,745 |
Deferred tax asset | 45,325 | 23,276 |
Total assets | 453,733 | 504,955 |
Current liabilities: | ' | ' |
Accounts payable and other accrued obligations | 71,320 | 93,811 |
Accrued compensation and related expenses | 7,771 | 4,835 |
Deferred revenue | 1,068 | 12,300 |
Deferred development costs | 3,251 | 856 |
Accrued drug development costs | 10,580 | 11,441 |
Total current liabilities | 93,990 | 123,243 |
Deferred revenue-less current portion | 4,140 | 2,937 |
Deferred development costs, less current portion | 15,400 | 11,377 |
Deferred payment contingency | ' | 2,287 |
Other long-term obligations | 12,839 | 1,430 |
Revolving line of credit | 25,000 | 75,000 |
Total liabilities | 151,369 | 216,274 |
Commitments and contingencies | ' | ' |
Stockholders' equity: | ' | ' |
Preferred stock | ' | ' |
Common stock, $0.001 par value; 175,000,000 shares authorized; 63,825,102 and 60,026,675 shares issued and outstanding at September 30, 2013 and December 31, 2012, respectively | 64 | 60 |
Additional paid-in capital | 499,783 | 463,710 |
Accumulated other comprehensive income | 635 | 273 |
Accumulated deficit | -198,241 | -175,485 |
Total stockholders' equity | 302,364 | 288,681 |
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | 453,733 | 504,955 |
Series B junior participating preferred stock [Member] | ' | ' |
Stockholders' equity: | ' | ' |
Preferred stock | ' | ' |
Series E convertible voting preferred stock [Member] | ' | ' |
Stockholders' equity: | ' | ' |
Preferred stock | $123 | $123 |
Condensed_Consolidated_Balance1
Condensed Consolidated Balance Sheets (Parenthetical) (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
In Thousands, except Share data, unless otherwise specified | ||
Allowance for doubtful accounts receivable | $254 | $228 |
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 | 63,825,102 | 60,026,675 |
Common stock, shares outstanding | 63,825,102 | 60,026,675 |
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 |
Preferred stock, liquidation value | $240 | $240 |
Condensed_Consolidated_Stateme
Condensed Consolidated Statements of Operations (USD $) | 3 Months Ended | 9 Months Ended | ||
In Thousands, except Share data, unless otherwise specified | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 |
Revenues: | ' | ' | ' | ' |
Product sales, net | $41,439 | $65,871 | $102,998 | $188,282 |
License fees | 1,000 | 3,171 | 11,340 | 9,321 |
Total revenues | 42,439 | 69,042 | 114,338 | 197,603 |
Operating expenses: | ' | ' | ' | ' |
Cost of product sales (excludes amortization and impairment of intangible assets) | 8,221 | 11,155 | 22,271 | 31,402 |
Selling, general and administrative | 29,003 | 22,925 | 73,601 | 64,230 |
Research and development | 13,567 | 10,019 | 35,910 | 27,838 |
Amortization and impairment of intangible assets | 4,935 | 1,834 | 14,829 | 4,400 |
Total operating expenses | 55,726 | 45,933 | 146,611 | 127,870 |
(Loss) income from operations | -13,287 | 23,109 | -32,273 | 69,733 |
Other income (expense), net | 742 | 293 | -738 | -1,076 |
(Loss) income before income taxes | -12,545 | 23,402 | -33,011 | 68,657 |
Benefit (provision) for income taxes | 4,733 | -1,878 | 10,249 | 18,054 |
Net (loss) income | ($7,812) | $21,524 | ($22,762) | $86,711 |
Net (loss) income per share: | ' | ' | ' | ' |
Basic | ($0.13) | $0.37 | ($0.38) | $1.48 |
Diluted | ($0.13) | $0.33 | ($0.38) | $1.34 |
Weighted average shares outstanding: | ' | ' | ' | ' |
Basic | 61,903,242 | 58,912,031 | 60,013,842 | 58,564,176 |
Diluted | 61,903,242 | 65,139,606 | 60,013,842 | 64,880,786 |
Condensed_Consolidated_Stateme1
Condensed Consolidated Statements of Comprehensive (Loss) Income (USD $) | 3 Months Ended | 9 Months Ended | ||
In Thousands, unless otherwise specified | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 |
Statement Of Partners Capital [Abstract] | ' | ' | ' | ' |
Net (loss) income | ($7,812) | $21,524 | ($22,762) | $86,711 |
Other comprehensive (loss) income, net of tax: | ' | ' | ' | ' |
Unrealized gain (loss) on securities | -293 | 1,267 | 674 | 966 |
Foreign currency translation adjustments | -122 | -60 | 49 | -57 |
Income tax | ' | ' | -361 | ' |
Other comprehensive income (loss), net | -415 | 1,207 | -362 | 909 |
Total comprehensive (loss) income | ($8,227) | $22,731 | ($23,124) | $87,620 |
Condensed_Consolidated_Stateme2
Condensed Consolidated Statements of Cash Flows (USD $) | 9 Months Ended | |
In Thousands, unless otherwise specified | Sep. 30, 2013 | Sep. 30, 2012 |
Cash Flows From Operating Activities: | ' | ' |
Net (loss) income | ($22,762) | $86,711 |
Adjustments to reconcile net (loss) income to net cash (used in) provided by operating activities: | ' | ' |
Amortization of deferred revenue | -11,300 | -9,225 |
Depreciation and amortization | 16,249 | 6,714 |
Stock-based compensation | 8,662 | 9,424 |
Change in fair value of common stock warrants | 202 | ' |
Deferred income tax benefit | -10,016 | -33,298 |
Provision (recovery) for bad debt | 59 | -72 |
Provision for inventory obsolescence | 1,871 | 522 |
Loss on disposal of assets | ' | 115 |
Change in fair value of deferred development costs and deferred payment contingency | -2,869 | ' |
Impairment of intangible assets | 1,023 | ' |
Foreign currency remeasurement loss | 675 | 847 |
Excess tax benefits from share-based compensation | ' | -3,752 |
Changes in operating assets and liabilities: | ' | ' |
Accounts receivable, net | 37,187 | -32,334 |
Inventories, net | -1,424 | -492 |
Prepaid expenses and other assets | -3,193 | 9,977 |
Accounts payable and other accrued obligations | -26,104 | 26,618 |
Accrued compensation and related expenses | 1,324 | 496 |
Accrued drug development costs | -861 | 746 |
Deferred revenue and other credits | 1,271 | 865 |
Net cash (used in) provided by operating activities | -10,006 | 63,862 |
Cash Flows From Investing Activities: | ' | ' |
Sales and maturities of marketable securities | ' | 71,400 |
Purchases of marketable securities | ' | -26,386 |
Acquisition of Melphalan license | -3,000 | ' |
Purchases of property and equipment | -127 | -304 |
Purchases of available-for-sale securities | ' | -1,712 |
Net cash used in investing activities | -14,316 | -115,701 |
Cash Flows From Financing Activities: | ' | ' |
Proceeds from issuance of common stock from stock option exercises | 2,970 | 4,592 |
Proceeds from contributions to ESPP | 197 | 372 |
Payments to acquire treasury stock | -1,652 | -8,948 |
Repurchase of shares to satisfy minimum tax withholding for restricted stock vesting | -612 | -492 |
Proceeds from Munidpharma collaboration amendment | 7,000 | ' |
Proceeds from revolving line of credit | 100,000 | 75,000 |
Repayment of revolving line of credit | -150,000 | ' |
Repayment of capital leases | ' | -9 |
Payment of debt issuance costs | ' | -475 |
Excess tax benefits from share-based compensation | ' | 3,752 |
Net cash (used in) provided by financing activities | -42,097 | 73,792 |
Effect of exchange rates on cash | -1,305 | 128 |
Net (decrease) increase in cash and cash equivalents | -67,724 | 22,081 |
Cash and cash equivalents-beginning of period | 139,698 | 121,202 |
Cash and cash equivalents-end of period | 71,974 | 143,283 |
Supplemental Disclosure of Cash Flow Information: | ' | ' |
Melphalan license included in intangible assets and other long term obligations | 4,700 | ' |
Inventory liability assumed in acquisition | ' | 580 |
Retirement of treasury shares | 1,652 | 11,874 |
ZEVALIN Rights [Member] | ' | ' |
Cash Flows From Investing Activities: | ' | ' |
Acquisition, net of cash acquired | ' | -25,435 |
Talon Therapeutics, Inc. [Member] | ' | ' |
Cash Flows From Investing Activities: | ' | ' |
Acquisition of Melphalan license | -11,300 | ' |
Acquisition, net of cash acquired | -11,189 | ' |
Allos Therapeutics, Inc. [Member] | ' | ' |
Cash Flows From Investing Activities: | ' | ' |
Acquisition, net of cash acquired | ' | ($133,264) |
Description_of_Business_Basis_
Description of Business, Basis of Presentation, and Operating Segment | 9 Months Ended | |||
Sep. 30, 2013 | ||||
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 four drugs: | ||||
• | 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; and | |||
• | Marqibo® injection for patients in the U.S. with Philadelphia chromosome–negative acute lymphoblastic leukemia. | |||
We also have a diversified pipeline of product candidates in advanced-stage Phase 2 and Phase 3 studies. We have assembled an integrated in-house scientific team, including formulation development, clinical development, medical research, regulatory affairs, biostatistics and data management, and have established a commercial infrastructure for the marketing of our drug products. We also leverage the expertise of our worldwide partners to assist in the execution of our business strategies. | ||||
(b) Basis of Presentation | ||||
The accompanying Condensed Consolidated Financial Statements in this Quarterly Report on Form 10-Q have been prepared in accordance with generally accepted accounting principles in the United States (“GAAP”) and the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”). These financial statements include the financial position, results of operations, and cash flows of the Company, including its wholly-owned subsidiaries. All inter-company accounts and transactions have been eliminated in consolidation. | ||||
We own fifty-percent of our Canadian affiliate, Spectrum Pharma Canada (“SPC”). We fund all of the expenses of this entity, and since we are deemed to be its “primary beneficiary” (as defined under applicable GAAP), SPC is reported in our financial statements as if it were a wholly-owned subsidiary. | ||||
On April 1, 2012, we acquired the licensing rights outside of the U.S. to market ZEVALIN (the “ZEVALIN Rights”); on September 5, 2012, we acquired Allos Therapeutics, Inc. (“Allos”); and on July 17, 2013, we acquired Talon Therapeutics, Inc. (“Talon”). Our financial statements include the assets acquired, liabilities assumed, operating results and cash flows of these acquisitions, beginning with the respective acquisition date for each. | ||||
The unaudited condensed consolidated financial statements reflect all adjustments which are of a normal recurring nature (except for the correction of certain prior period immaterial errors, as discussed in Note 2). In the opinion of management, these adjustments are necessary to fairly state our financial position as of September 30, 2013, and the results of our operations and cash flows for the three and nine months ended September 30, 2013 and 2012. | ||||
The results of operations for the three and nine months ended September 30, 2013 are not necessarily indicative of the results that may be expected for the year ending December 31, 2013, or for any other periods. The unaudited financial statements included in this Quarterly Report on Form 10-Q do not include all disclosures required by GAAP for annual periods and should be read in conjunction with our audited financial statements for the year ended December 31, 2012, included in our Annual Report on Form 10-K. | ||||
(c) Operating Segment | ||||
We have one reportable operating segment that is focused exclusively on developing and commercializing oncology and hematology drug products. For the three and nine months ended September 30, 2013 and 2012, 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. |
Correction_of_Immaterial_Error
Correction of Immaterial Errors Within Previously Issued Condensed Consolidated Financial Statements | 9 Months Ended | ||||||||||||||||
Sep. 30, 2013 | |||||||||||||||||
Accounting Changes And Error Corrections [Abstract] | ' | ||||||||||||||||
Correction of Immaterial Errors Within Previously Issued Condensed Consolidated Financial Statements | ' | ||||||||||||||||
2 | Correction of Immaterial Errors Within Previously Issued Condensed Consolidated Financial Statements | ||||||||||||||||
Overview | |||||||||||||||||
In connection with the preparation of our accompanying Condensed Consolidated Financial Statements, we determined that our June 30, 2013 Condensed Consolidated Balance Sheet, included within our Form 10-Q for the quarter ended June 30, 2013, presented a $7.7 million overstatement within “accounts payable and other accrued obligations” and “accrued drug development costs”. However, this error had no resulting impact to our September 30, 2013 cash balance. | |||||||||||||||||
The components of the “accounts payable and other accrued obligations” and “accrued drug development costs” overstatement include (a) $6.7 million of excess accruals that correspond with our research and development and sales and marketing activities which accumulated from January 1, 2007 through June 30, 2013, and (b) $1.0 million of excess liabilities that were recorded as part of our business combination accounting for our 2009 acquisition of RIT Oncology, LLC. As with the $6.7 million of excess accruals, this $1.0 million did not require settlement, and was not timely identified as such. | |||||||||||||||||
Materiality Assessment | |||||||||||||||||
Our management evaluated the materiality of these errors from a qualitative and quantitative perspective, as required by applicable SEC and GAAP guidance. Based on this evaluation, our management concluded that these errors were not material to any of our previously reported quarterly or annual periods, and therefore, the amendment of previously filed reports with the SEC are not required for this matter. However, the correction of these accumulated errors would be material if corrected in full (i.e., the entire $7.7 million) within the current reporting period’s Condensed Consolidated Statements of Operations. Therefore, we have revised within this Quarterly Report on Form 10-Q, our previously reported financial information as of December 31, 2012, and for the three and nine months ended September 30, 2012 for those errors specific to each period. | |||||||||||||||||
In addition, our accompanying December 31, 2012 Condensed Consolidated Balance Sheet has been restated to reflect the correction of certain additional errors related to our conclusion that the indefinite-lived intangible asset acquired and recognized as part of our acquisition of Allos Therapeutics, Inc. in September 2012, as in-process research & development (IPR&D), should instead be recognized at the acquisition date as a definite-lived intangible asset. This matter is further discussed in our Form 10-Q/A, Note 1A – “Restatement of Condensed Consolidated Financial Statements” for the quarterly period ended June 30, 2013. | |||||||||||||||||
Financial Statement Presentation – Current and Future Periods | |||||||||||||||||
Our accompanying December 31, 2012 Condensed Consolidated Balance Sheet reflects the correction of the cumulative error of $7.2 million that existed through that date, as an adjustment to “accumulated deficit,” and the correction of the corresponding accounts of “deferred tax assets,” “accounts payable and other accrued obligations,” and “accrued drug development costs.” The remaining $0.5 million correction is reflected as a reduction of “selling general and administrative” and “research and development” expenses within the accompanying Condensed Consolidated Statements of Operations. This correction reduced operating expenses by $0.1 million and $0.5 million for the three and nine months ended September 30, 2013, respectively. | |||||||||||||||||
The prior period financial statements included within this Quarterly Report on Form 10-Q for the three and nine months ended September 30, 2012, within the accompanying Condensed Consolidated Statements of Operations, and Condensed Consolidated Cash Flows reflect reductions of “selling general and administrative” and “research and development” expenses for the errors that correspond to each period. | |||||||||||||||||
The impact of this aggregate $7.7 million error to our previously reported 2012 annual period, and our previously reported 2013 and 2012 quarterly periods is summarized below. These amounts will be reported within our future Form 10-Q and 10-K filings, and any other SEC filing that includes financial information covering the impacted periods on this “as restated” basis: | |||||||||||||||||
Consolidated Balance Sheet for | |||||||||||||||||
Year Ended December 31, 2012 | |||||||||||||||||
As Reported | As Restated | ||||||||||||||||
Intangible assets, net | $ | 202,311 | $ | 200,234 | |||||||||||||
Goodwill | 28,973 | 7,279 | |||||||||||||||
Deferred tax assets | 12,473 | 23,276 | |||||||||||||||
Other assets | 7,569 | 6,745 | |||||||||||||||
Total assets | 506,274 | 504,955 | |||||||||||||||
Accounts payable and other accrued obligations | 95,297 | 93,811 | |||||||||||||||
Accrued drug development costs | 15,109 | 11,441 | |||||||||||||||
Total current liabilities | 128,397 | 123,243 | |||||||||||||||
Total liabilities | 221,428 | 216,274 | |||||||||||||||
Accumulated deficit | (179,320 | ) | (175,485 | ) | |||||||||||||
Total stockholders’ equity | 284,846 | 288,681 | |||||||||||||||
Condensed Consolidated Results of Operations | |||||||||||||||||
Three Months | Three Months | Nine Months | Nine Months | ||||||||||||||
Ended | Ended | Ended | Ended | ||||||||||||||
September 30, | September 30, | September 30, | September 30, | ||||||||||||||
2012 | 2012 | 2012 | 2012 | ||||||||||||||
(As Reported) | (As Restated) | (As Reported) | (As Restated) | ||||||||||||||
Research and development | $ | 10,183 | $ | 10,019 | $ | 28,657 | $ | 27,838 | |||||||||
Selling, general and administrative | 23,114 | 22,925 | 64,723 | 64,230 | |||||||||||||
Total operating expenses | 46,286 | 45,933 | 129,182 | 127,870 | |||||||||||||
Income from operations | 22,756 | 23,109 | 68,421 | 69,733 | |||||||||||||
Income before provision for income taxes | 23,049 | 23,402 | 67,345 | 68,657 | |||||||||||||
(Provision) benefit for income taxes | (1,737 | ) | (1,878 | ) | 18,579 | 18,054 | |||||||||||
Net income | 21,312 | 21,524 | 85,924 | 86,711 | |||||||||||||
Net income per share, basic | $ | 0.36 | $ | 0.37 | $ | 1.47 | $ | 1.48 | |||||||||
Net income per share, diluted | $ | 0.33 | $ | 0.33 | $ | 1.32 | $ | 1.34 | |||||||||
Condensed Consolidated Statement of Cash Flows | |||||||||||||||||
Nine Months Ended | Nine Months Ended | ||||||||||||||||
September 30, 2012 | September 30, 2012 | ||||||||||||||||
(As Reported) | (As Restated) | ||||||||||||||||
Net income | $ | 85,924 | $ | 86,711 | |||||||||||||
Changes in operating expenses and liabilities: | |||||||||||||||||
Accounts payable and other accrued obligations | 26,586 | 26,618 | |||||||||||||||
Accrued drug development costs | 1,565 | 746 | |||||||||||||||
Net cash provided by operating activities | 63,862 | 63,862 | |||||||||||||||
For the three and nine months ended September 30, 2013 and 2012, the Condensed Consolidated Statements of Cash Flows were impacted by the adjustments to net income (loss) discussed above. However, its effect on the annual cash flows for these periods was limited to an increase to “net income” and a corresponding and equal change to “deferred income tax benefit,” “accounts payable and other accrued obligations,” and “accrued drug development costs”, with no resulting net impact to cash provided by operating activities. |
Use_of_Estimates_and_Summary_o
Use of Estimates and Summary of Significant Accounting Policies | 9 Months Ended | ||
Sep. 30, 2013 | |||
Accounting Policies [Abstract] | ' | ||
Use of Estimates and Summary of Significant Accounting Policies | ' | ||
3 | Use of Estimates and Summary of Significant Accounting Policies | ||
The preparation of financial statements in conformity with GAAP requires our management to make 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) revenue adjustments; (ii) the collectability of customer accounts; (iii) whether the cost of inventories can be recovered; (iv) the 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; and (vii) the potential outcome of litigation. | |||
Such estimates are based on our management’s judgment which takes into account historical experience and various assumptions. 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 impact on our preparation of the accompanying Condensed Consolidated Financial Statements: | |||
(i) Revenue Recognition | |||
Product Sales: We sell our products to wholesalers and distributors. Our wholesalers and distributors purchase our products and sell the products directly to end-users, such as clinics, hospitals, and private oncology-based practices. Revenue from product sales is recognized upon shipment of product 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 future returns. | ||
We calculate a provision for estimated product returns, sales discounts, rebates, government chargebacks, and distribution and data fees (collectively, “gross-to-net estimates”) – the nature of which is discussed within Note 2 to our 2012 Annual Report on Form 10-K. Our gross revenue is reduced by our gross-to-net estimates. We defer revenue recognition in full if/when these estimates are not reasonably determinable at the time of sale. | |||
License Fees: We recognize license fees based on the terms of each contractual agreement. In general, this results in periodic revenue recognition as the third-party licensee has sales for which we are entitled to a royalty, or in certain cases, a lump-sum license fee in which revenue is recognized in that period. | |||
(ii) Accounts Receivable | |||
Trade accounts receivable are recorded at the invoiced amount, 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. | |||
(iii) Inventories | |||
We value inventory at the lower of the actual cost to purchase or manufacture the inventory, or the market value for such inventory. 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. The provision is based on actual loss experience and a forecast of product demand compared to its remaining shelf life. | |||
(iv) Goodwill and Intangible Assets | |||
Goodwill represents the excess of acquisition cost over the fair value of the net assets of the acquired businesses. Goodwill has an indefinite useful life and is not amortized, but instead tested for impairment annually unless there are interim impairment indicators. We perform our annual evaluation as of October 1 each year. | |||
We evaluate the recoverability of indefinite and definite lived intangible assets whenever events or changes in circumstances 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. | ||
(v) Foreign Currency Translation | |||
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 foreign currencies are included as a separate component of accumulated other comprehensive income (loss) in the statement of comprehensive income (loss). | |||
We record foreign currency transactions at the exchange rate prevailing at the date of the transaction with resultant gains and losses being included in results of operations. Foreign currency transaction gains and losses have not been significant for any period presented. | |||
(vi) Comprehensive Income (Loss) | |||
Comprehensive income (loss) is calculated in accordance with authoritative guidance which requires the disclosure of all components of comprehensive income, including net income (loss) and changes in equity during a period from transactions and other events and circumstances generated from non-owner sources. Our accumulated other comprehensive income (loss) at September 30, 2013 and 2012, respectively consisted primarily of foreign currency translation adjustments and net unrealized gains/losses on investments in marketable securities as of each date. | |||
(vii) Basic and Diluted Net Income (Loss) per Share | |||
We calculate basic and diluted net income (loss) per share using the weighted average number of common shares outstanding during the periods presented, and adjust the amount of net income (loss) used in this calculation for preferred stock dividends (if any) declared during the period. In periods of a net loss position, 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 dilutive stock options, warrants and other common stock equivalents outstanding during the period. | |||
(viii) Income Taxes | |||
We record 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. We have recorded a valuation allowance to reduce our net deferred tax assets, because we believe that, based upon a weighting of positive and negative factors, it is more likely than not that these deferred tax assets will not be realized. If we were to determine that we would be able to realize our deferred tax assets in the future, an adjustment to the valuation allowance of our deferred tax assets would increase net income in the period such determination was made. In the event that we were assessed interest and/or penalties from taxing authorities, such amounts would be included in “income tax expense” within the Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) in the period the notice was received. | |||
(ix) Research and Development Costs | |||
Research and development costs are expensed as incurred. | |||
(x) Fair Value Measurements | |||
We measure fair value based on the prices that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. 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 accessible at the measurement date. The fair value hierarchy gives the highest priority to Level 1 inputs. | |||
Level 2: Observable prices that are based on inputs not quoted on active markets, but corroborated by market data. These inputs include quoted prices for similar assets or liabilities; quoted market prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. | |||
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 equivalents” within our accompanying Condensed Consolidated Balance Sheets consist of bank deposits and certificates of deposit. Certificates of deposit are valued at cost, which approximates fair value due to the short-term maturities of these instruments. “Marketable securities” consist of U.S. Government treasury bills, U.S. treasury-backed securities, and corporate deposits, which are stated at fair value (utilizing Level 1 inputs). | |||
The fair value of our “deferred development cost” liability and our “deferred payment contingency” within our accompanying Condensed Consolidated Balance Sheets was valued using a model commonly referred to as 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) internal 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. | |||
“Other long-term obligations” within our accompanying Condensed Consolidated Balance Sheets represent future amounts we may be required to pay in conjunction with various business combinations (i.e., contingent consideration) – see Note 8(a) for a discussion of CVRs granted as part of our acquisition of Talon). The fair value of the liability associated with FDA approval of Captisol-enabled® melphalan (see Note 8(b)) is also included within “other long-term obligations”. These liabilities within our accompanying Condensed Consolidated Balance Sheets are valued using Level 3 inputs which include probabilities and assumptions related to the timing and likelihood of achievement of regulatory and sales milestones and other contractual performance conditions. These inputs are reviewed for reasonableness by management on at least a quarterly basis. |
Balance_Sheet_Account_Detail
Balance Sheet Account Detail | 9 Months Ended | ||||||||||||||||||||||||||||
Sep. 30, 2013 | |||||||||||||||||||||||||||||
Text Block [Abstract] | ' | ||||||||||||||||||||||||||||
Balance Sheet Account Detail | ' | ||||||||||||||||||||||||||||
4 | Balance Sheet Account Detail | ||||||||||||||||||||||||||||
(a) Cash and Marketable Securities | |||||||||||||||||||||||||||||
As of September 30, 2013, we held substantially all of our cash, cash equivalents, and marketable securities 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 and 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. | |||||||||||||||||||||||||||||
Cash, equivalents and marketable securities, including long term bank certificates of deposits, and investments totaled $78.4 million and $145.5 million as of September 30, 2013 and December 31, 2012, respectively. Long term bank certificates of deposit include a $0.3 million restricted certificate of deposit that collateralizes tenant improvement obligations to the lessor of our principal offices. The following is a summary of such investments: | |||||||||||||||||||||||||||||
Amortized | Gross | Gross | Estimated | Cash | Marketable Security | ||||||||||||||||||||||||
Cost | Unrealized | Unrealized | fair | ||||||||||||||||||||||||||
Gains | Losses | Value | Current | Long | |||||||||||||||||||||||||
Term | |||||||||||||||||||||||||||||
September 30, 2013 | |||||||||||||||||||||||||||||
Cash and equivalents | $ | 71,974 | $ | — | $ | — | $ | 71,974 | $ | 71,974 | $ | — | $ | — | |||||||||||||||
Bank CDs (including restricted certificate of deposit of $250) | 252 | — | — | 252 | — | 252 | — | ||||||||||||||||||||||
Money market currency funds | 3,060 | — | — | 3,060 | — | 3,060 | — | ||||||||||||||||||||||
Other securities (included in other assets) | 1,747 | 1,407 | — | 3,154 | — | — | 3,154 | ||||||||||||||||||||||
Total investments | $ | 77,033 | $ | 1,407 | $ | — | $ | 78,440 | $ | 71,974 | $ | 3,312 | $ | 3,154 | |||||||||||||||
December 31, 2012 | |||||||||||||||||||||||||||||
Cash and equivalents | $ | 139,698 | $ | — | $ | — | $ | 139,698 | $ | 139,698 | $ | — | $ | — | |||||||||||||||
Bank CDs (including restricted certificate of deposit of $250) | 987 | — | — | 987 | — | 987 | — | ||||||||||||||||||||||
Money market currency funds | 2,323 | — | — | 2,323 | — | 2,323 | — | ||||||||||||||||||||||
Other securities (included in other assets) | 1,747 | 733 | — | 2,480 | — | — | 2,480 | ||||||||||||||||||||||
Total investments | $ | 144,755 | $ | 733 | $ | — | $ | 145,488 | $ | 139,698 | $ | 3,310 | $ | 2,480 | |||||||||||||||
As of September 30, 2013, none of the securities had been in a continuous unrealized loss position longer than one year. | |||||||||||||||||||||||||||||
(b) Inventories | |||||||||||||||||||||||||||||
Inventories, net of allowances consisted of the following: | |||||||||||||||||||||||||||||
September 30, | December 31, | ||||||||||||||||||||||||||||
2013 | 2012 | ||||||||||||||||||||||||||||
Raw materials | $ | 2,622 | $ | 887 | |||||||||||||||||||||||||
Work-in-process | 3,174 | 7,302 | |||||||||||||||||||||||||||
Finished goods | 8,846 | 6,289 | |||||||||||||||||||||||||||
$ | 14,642 | $ | 14,478 | ||||||||||||||||||||||||||
(c) Intangible Assets and Goodwill | |||||||||||||||||||||||||||||
Intangible assets consist of the following: | |||||||||||||||||||||||||||||
September 30, 2013 | |||||||||||||||||||||||||||||
Gross | Accumulated | Foreign | Impairment | Net | |||||||||||||||||||||||||
Amount | Amortization | Currency | Amount | Amortization | |||||||||||||||||||||||||
Translation | Period (years) | ||||||||||||||||||||||||||||
Marqibo IPR&D | $ | 17,600 | $ | — | $ | — | $ | — | $ | 17,600 | n/a | ||||||||||||||||||
Marqibo developed technology | 26,900 | (508 | ) | — | — | 26,392 | 13 | ||||||||||||||||||||||
ZEVALIN marketing rights—U.S. | 41,900 | (22,525 | ) | — | — | 19,375 | 10 | ||||||||||||||||||||||
ZEVALIN marketing rights—Ex. U.S. | 23,490 | (4,501 | ) | 263 | — | 19,252 | 10 | ||||||||||||||||||||||
FUSILEV developed technology | 16,778 | (4,459 | ) | — | — | 12,319 | 9 | ||||||||||||||||||||||
FOLOTYN distribution rights* | 27,900 | (2,981 | ) | — | (1,023 | ) | 23,896 | 10 | |||||||||||||||||||||
FOLOTYN developed technology. | 118,400 | (8,308 | ) | — | — | 110,092 | 14 | ||||||||||||||||||||||
Melphalan IPR&D | 7,700 | — | — | — | 7,700 | n/a | |||||||||||||||||||||||
Total intangible assets | $ | 280,668 | $ | (43,282 | ) | $ | 263 | $ | (1,023 | ) | $ | 236,626 | |||||||||||||||||
* | On May 29, 2013, we amended our collaboration agreement 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., the FOLOTYN distribution rights). We determined that an impairment of the FOLOTYN distribution rights of $1.0 million resulted from the amendment and is recorded in the “amortization and impairment of intangible assets” in the accompanying Condensed Consolidated Statement of Operations for the nine months ended September 30, 2013. | ||||||||||||||||||||||||||||
Goodwill includes the following: | |||||||||||||||||||||||||||||
September 30, | December 31, | ||||||||||||||||||||||||||||
2013 | 2012 | ||||||||||||||||||||||||||||
(As Restated) | |||||||||||||||||||||||||||||
Acquisition of Zevalin Rights | 2,525 | 2,525 | |||||||||||||||||||||||||||
Acquisition of Allos | 5,346 | 4,791 | |||||||||||||||||||||||||||
Foreign exchange translation effects | 29 | (37 | ) | ||||||||||||||||||||||||||
$ | 7,900 | $ | 7,279 | ||||||||||||||||||||||||||
(d) Accounts payable and accrued obligations | |||||||||||||||||||||||||||||
Accounts payable and other accrued obligations consisted of the following: | |||||||||||||||||||||||||||||
September 30, | December 31, | ||||||||||||||||||||||||||||
2013 | 2012 | ||||||||||||||||||||||||||||
(As restated) | |||||||||||||||||||||||||||||
Trade payables | $ | 22,958 | $ | 30,814 | |||||||||||||||||||||||||
Allowance for rebates | 25,395 | 11,023 | |||||||||||||||||||||||||||
Accrued product royalty | 9,019 | 12,275 | |||||||||||||||||||||||||||
Allowance for returns | 2,636 | 5,056 | |||||||||||||||||||||||||||
Accrued data and distribution fees | 2,995 | 8,449 | |||||||||||||||||||||||||||
Accrued GPO administrative fees | 2,196 | 2,650 | |||||||||||||||||||||||||||
Inventory management fee | 784 | 3,050 | |||||||||||||||||||||||||||
Accrued income taxes | — | 2,522 | |||||||||||||||||||||||||||
Allowance for chargebacks | 4,559 | 15,153 | |||||||||||||||||||||||||||
Other accrued obligations | 778 | 2,819 | |||||||||||||||||||||||||||
$ | 71,320 | $ | 93,811 | ||||||||||||||||||||||||||
Grossto_Net_Product_Sales
Gross-to Net Product Sales | 9 Months Ended | ||||||||||||||||
Sep. 30, 2013 | |||||||||||||||||
Text Block [Abstract] | ' | ||||||||||||||||
Gross-to Net Product Sales | ' | ||||||||||||||||
5 | Gross-to Net Product Sales | ||||||||||||||||
The below table presents a gross-to-net product sales reconciliation for the three and nine months ended September 30, 2013 and 2012 is as follows: | |||||||||||||||||
Three Months Ended | Nine months Ended | ||||||||||||||||
September 30, | September 30, | ||||||||||||||||
2013 | 2012 | 2013 | 2012 | ||||||||||||||
Gross product sales | $ | 61,256 | $ | 91,805 | $ | 161,750 | $ | 279,075 | |||||||||
Government rebates and chargebacks | (15,136 | ) | (16,368 | ) | (46,219 | ) | (65,641 | ) | |||||||||
Data, distribution and GPO fees | (4,631 | ) | (7,898 | ) | (14,677 | ) | (21,369 | ) | |||||||||
Prompt pay discount | (50 | ) | (1,078 | ) | (155 | ) | (3,684 | ) | |||||||||
Product returns allowance | — | (590 | ) | 2,299 | (99 | ) | |||||||||||
Net product sales | $ | 41,439 | $ | 65,871 | $ | 102,998 | $ | 188,282 | |||||||||
Net_Income_Loss_Per_Share
Net Income (Loss) Per Share | 9 Months Ended | ||||||||||||
Sep. 30, 2013 | |||||||||||||
Earnings Per Share [Abstract] | ' | ||||||||||||
Net Income (Loss) Per Share | ' | ||||||||||||
6 | Net Income (Loss) Per Share | ||||||||||||
Net Loss | Weighted- | Net Loss | |||||||||||
Average | Per | ||||||||||||
Shares | Share | ||||||||||||
Outstanding | |||||||||||||
(Denominator) | |||||||||||||
Three Months Ended September 30, 2013 | |||||||||||||
Basic and diluted loss per share: | $ | (7,812 | ) | 61,903,242 | $ | (0.13 | ) | ||||||
The following table sets forth the number of shares excluded from the computation of diluted earnings per share, as their inclusion would be anti-dilutive: | |||||||||||||
September 30, | |||||||||||||
2013 | |||||||||||||
Preferred shares | 40,000 | ||||||||||||
Options | 2,881,993 | ||||||||||||
Incremental shares assumed issued on exercise of in the money warrants | 132,565 | ||||||||||||
Unvested restricted stock | 1,044,904 | ||||||||||||
4,099,288 | |||||||||||||
Net Income | Weighted- | Net Income | |||||||||||
Average | Per | ||||||||||||
Shares | Share | ||||||||||||
Outstanding | |||||||||||||
(Denominator) | |||||||||||||
Three Months Ended September 30, 2012 – As restated | |||||||||||||
Basic net income per share: | $ | 21,524 | 58,912,031 | $ | 0.37 | ||||||||
Diluted earnings per share: | |||||||||||||
Dilutive preferred shares | 40,000 | ||||||||||||
Dilutive options | 4,863,932 | ||||||||||||
Incremental shares assumed issued on exercise of in the money warrants | 279,518 | ||||||||||||
Unvested restricted stock | 1,044,125 | ||||||||||||
Diluted earnings per share | $ | 21,524 | 65,139,606 | $ | 0.33 | ||||||||
Potentially dilutive securities not included above since they were antidilutive: | |||||||||||||
Antidilutive options excluded from the calculation | 696,500 | ||||||||||||
Net Loss | Weighted- | Net Loss | |||||||||||
Average | Per | ||||||||||||
Shares | Share | ||||||||||||
Outstanding | |||||||||||||
(Denominator) | |||||||||||||
Nine Months Ended September 30, 2013 | |||||||||||||
Basic net loss per share: | $ | (22,762 | ) | 60,013,842 | $ | (0.38 | ) | ||||||
The following table sets forth the number of shares excluded from the computation of diluted earnings per share, as their inclusion would be anti-dilutive: | |||||||||||||
September 30, | |||||||||||||
2013 | |||||||||||||
Preferred shares | 40,000 | ||||||||||||
Options | 3,247,710 | ||||||||||||
Incremental shares assumed issued on exercise of in the money warrants | 160,486 | ||||||||||||
Unvested restricted stock | 1,044,904 | ||||||||||||
4,493,100 | |||||||||||||
Net Income | Weighted- | Net Income | |||||||||||
Average | Per | ||||||||||||
Shares | Share | ||||||||||||
Outstanding | |||||||||||||
(Denominator) | |||||||||||||
Nine Months Ended September 30, 2012 – As restated | |||||||||||||
Basic earnings per share: | $ | 86,711 | 58,564,176 | $ | 1.48 | ||||||||
Diluted earnings per share: | |||||||||||||
Dilutive preferred shares | 40,000 | ||||||||||||
Dilutive options | 4,959,558 | ||||||||||||
Incremental shares assumed issued on exercise of in the money warrants | 272,927 | ||||||||||||
Unvested restricted stock | 1,044,125 | ||||||||||||
Diluted earnings per share | $ | 86,711 | 64,880,786 | $ | 1.34 | ||||||||
Potentially dilutive securities not included above since they were antidilutive: | |||||||||||||
Antidilutive options excluded from the calculation | 737,230 | ||||||||||||
Fair_Value_Measurements
Fair Value Measurements | 9 Months Ended | ||||||||||||||||
Sep. 30, 2013 | |||||||||||||||||
Fair Value Disclosures [Abstract] | ' | ||||||||||||||||
Fair Value Measurements | ' | ||||||||||||||||
7 | 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 3(x)): | |||||||||||||||||
Fair Value Measurements | |||||||||||||||||
Level 1 | Level 2 | Level 3 | Total | ||||||||||||||
September 30, 2013 | |||||||||||||||||
Assets: | |||||||||||||||||
Cash and equivalents | $ | 71,974 | $ | — | $ | — | $ | 71,974 | |||||||||
Bank CDs (including restricted certificate of deposit of $250) | — | 252 | — | 252 | |||||||||||||
Money market currency funds | — | 3,060 | — | 3,060 | |||||||||||||
Cash and equivalents, and marketable securities and investments | 71,974 | 3,312 | — | 75,286 | |||||||||||||
Deferred compensation investments, including life insurance cash surrender value | — | 4,757 | — | 4,757 | |||||||||||||
Other securities | 3,154 | — | — | 3,154 | |||||||||||||
$ | 75,128 | $ | 8,069 | $ | — | $ | 83,197 | ||||||||||
Liabilities: | |||||||||||||||||
Deferred executive compensation liability | — | 3,721 | — | 3,721 | |||||||||||||
Deferred development costs | — | — | 18,651 | 18,651 | |||||||||||||
Melphalan license contingent consideration | — | — | 4,700 | 4,700 | |||||||||||||
Contingent value right | — | — | 6,500 | 6,500 | |||||||||||||
$ | — | $ | 3,721 | $ | 29,851 | $ | 33,572 | ||||||||||
The following summarizes the activity of Level 3 inputs measured on a recurring basis: | |||||||||||||||||
Fair Value Measurements of | |||||||||||||||||
Unobservable Inputs (Level 3) | |||||||||||||||||
Balance at December 31, 2011 | $ | — | |||||||||||||||
Transfers in / (out) of Level 3: | |||||||||||||||||
Deferred development costs | 12,233 | ||||||||||||||||
Deferred payment contingency | 2,287 | ||||||||||||||||
Balance at December 31, 2012 | 14,520 | ||||||||||||||||
Transfers in / (out) of Level 3: | |||||||||||||||||
Other long term liabilities | 4,700 | ||||||||||||||||
Deferred development costs | 6,418 | ||||||||||||||||
Deferred payment contingency | (2,287 | ) | |||||||||||||||
Contingent Value Right | 6,500 | ||||||||||||||||
Balance at September 30, 2013 | $ | 29,851 | |||||||||||||||
Business_Combinations
Business Combinations | 9 Months Ended | ||||||||||||||||
Sep. 30, 2013 | |||||||||||||||||
Business Combinations [Abstract] | ' | ||||||||||||||||
Business Combinations | ' | ||||||||||||||||
8 | Business Combinations | ||||||||||||||||
(a) Acquisition of Talon Therapeutics, Inc. | |||||||||||||||||
Talon Acquisition Overview | |||||||||||||||||
On July 16, 2013, we entered into a Securities Purchase Agreement with Talon Therapeutics, Inc. (“Talon”), whereby, on July 17, 2013, we purchased all of its then outstanding shares of common stock. 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 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”) valued by us of $6.5 million. | |||||||||||||||||
The CVR was valued using a valuation model that probability-weights expected outcomes (ranging from 0% to 100%) and discounts those amounts to their present value, using a discount rate of 25% (these represent Level 3 inputs – see Note 3(x)). 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 | ||||||||||||||||
Since July 17, 2013, the results of operations of the former Talon business have been included in the accompanying Condensed Consolidated Statements of Operations for the three and nine months ended September 30, 2013. From July 17, 2013 through September 30, 2013, our revenue derived from the former Talon business was approximately $0.1 million. We had nominal earnings from the Talon business during this period. | |||||||||||||||||
Direct Costs of the Talon Acquisition | |||||||||||||||||
Our direct costs of the Talon acquisition included employee severance, banker, legal, and accounting fees which aggregated to $5.7 million. This amount is included in “selling and general expenses” within the accompanying Condensed Consolidated Statements of Operations for the nine months ended September 30, 2013. | |||||||||||||||||
Consideration Transferred | |||||||||||||||||
The Talon acquisition purchase price was allocated to tangible and intangible assets acquired and liabilities assumed based upon their estimated fair value at the acquisition date. The following table summarizes the purchase price: | |||||||||||||||||
Cash consideration | $ | 11,300 | |||||||||||||||
Contingent value right | 6,500 | ||||||||||||||||
Spectrum shares of common stock | 26,300 | ||||||||||||||||
Total purchase consideration | $ | 44,100 | |||||||||||||||
Fair Value Estimate of Assets Acquired and Liabilities Assumed | |||||||||||||||||
Under the purchase method of accounting, the total purchase consideration is allocated to Talon net tangible and intangible assets based on the estimated fair values as of the closing date. The following table summarizes the estimated fair value of the net assets acquired as of July 17, 2013: | |||||||||||||||||
Cash and equivalents | $ | 131 | |||||||||||||||
Inventory | 611 | ||||||||||||||||
Prepaid expenses and other current assets | 109 | ||||||||||||||||
Property and equipment | 30 | ||||||||||||||||
Deferred tax asset | 3,950 | ||||||||||||||||
Identifiable intangible assets | 44,500 | ||||||||||||||||
Total assets acquired | 49,331 | ||||||||||||||||
Accounts payable & accrued liabilities | 5,231 | ||||||||||||||||
Total liabilities assumed | 5,231 | ||||||||||||||||
Net assets acquired | $ | 44,100 | |||||||||||||||
The acquired intangible assets consisted of developed technology and in-process research and development (“IPR&D”) for Marqibo treatment of acute lymphoblastic leukemia (“ALL”) and Marqibo treatment of non-Hodgkin’s lymphoma (“NHL”) as follows in the table below: | |||||||||||||||||
Value of | |||||||||||||||||
Intangible | Amortization | ||||||||||||||||
Assets | Period | ||||||||||||||||
Acquired | |||||||||||||||||
Developed technology —Marqibo for ALL | $ | 26,900 | 13 years | ||||||||||||||
IPR&D —Marqibo for NHL | 17,600 | (1) | |||||||||||||||
Total identifiable intangible assets | $ | 44,500 | |||||||||||||||
-1 | IPR&D is an intangible asset classified as an indefinite-lived until the completion or abandonment of the associated research and development effort, and will be amortized over an estimated useful life to be determined at the date the project is completed. IPR&D is not amortized during this period, but rather tested for impairment. | ||||||||||||||||
The fair value of the acquired in-process research and developed technology assets was estimated 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 deferred tax liability reflects future book-to-tax differences that are associated with the acquired IPR&D assets. | |||||||||||||||||
We believe that the fair values assigned to the Talon assets acquired and liabilities assumed were based upon reasonable assumptions, and we expect to complete our valuation of the deferred tax liability by December 31, 2013, which would have a corresponding impact on goodwill, if adjusted. Our allocations of the purchase price are largely dependent on discounted cash flow analyses of projects and products of Talon. There can be no assurance that the underlying assumptions we used to forecast the cash flows or the regulatory approvals will occur as we have estimated, if at all. | |||||||||||||||||
Supplemental Pro Forma Financial Information | |||||||||||||||||
The following unaudited pro forma financial information is presented to reflect the results of the Company’s consolidated operations for the three and nine months ended September 30, 2013 and 2012, as if the acquisition of Talon had occurred on January 1, 2012. To reflect the combined businesses, adjustments have been made to exclude one-time transaction costs and employee severance costs that were directly associated with the Talon acquisition. These pro forma results have been prepared for informational purposes only and may not be indicative of what operating results would have been, had the acquisition actually taken place on January 1, 2012, and may not be indicative of future operating results. | |||||||||||||||||
Three Months Ended | Nine months Ended | ||||||||||||||||
September 30, | September 30, | ||||||||||||||||
2013 | 2012 | 2013 | 2012 | ||||||||||||||
Pro Forma Total revenues | $ | 42,439 | $ | 69,042 | $ | 114,338 | $ | 197,603 | |||||||||
Pro Forma Cost of product sales | 8,221 | 11,155 | 22,271 | 31,402 | |||||||||||||
Pro Forma Total operating expenses | 53,026 | 51,633 | 140,911 | 133,570 | |||||||||||||
Pro Forma Net income (loss) | (5,112 | ) | 15,824 | (17,062 | ) | 81,011 | |||||||||||
Pro Forma Net income (loss) per share – basic | $ | (0.09 | ) | $ | 0.27 | $ | (0.29 | ) | $ | 1.38 | |||||||
Pro Forma Net income (loss) per share – diluted | $ | (0.09 | ) | $ | 0.24 | $ | (0.29 | ) | $ | 1.24 | |||||||
(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 from CyDex Pharmaceuticals, Inc. a wholly-owned subsidiary of Ligand Pharmaceuticals Incorporated (“Ligand”). The Captisol-enabled melphalan product candidate is currently in a pivotal trial being conducted by Ligand for use as a conditioning treatment prior to autologous stem cell transplant for patients with multiple myeloma. We assumed full responsibility for its ongoing clinical and regulatory development program. Under the agreement, we paid Ligand a license fee of $3.0 million on April 1, 2013. We are required to pay Ligand additional amounts upon achievement of certain regulatory milestones and net sales thresholds, and royalties on net sales of licensed products in all territories. | |||||||||||||||||
We accounted for the acquisition of these rights as a business combination, using the acquisition method of accounting. This requires that assets acquired and liabilities assumed be recognized at their fair values as of the purchase date and be recorded on the balance sheet. The process for estimating the fair values of identifiable intangible assets involves the use of significant estimates and assumptions, including estimating future cash flows and developing appropriate discount rates. Aggregate transaction costs of $15,000 are included in “selling and general expenses” within the accompanying Condensed Consolidated Statements of Operations for the nine months ended September 30, 2013. | |||||||||||||||||
Consideration Transferred | |||||||||||||||||
The acquisition-date fair value of the consideration transferred consisted of the following items: | |||||||||||||||||
Cash consideration | $ | 3,000 | |||||||||||||||
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 | |||||||||||||||
Acquired 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. The Captisol-enabled®, propylene glycol-free melphalan rights IPR&D will amortized over an estimated useful life to be determined at the date the project is complete. | |||||||||||||||||
We estimated the fair value of the in-process research and development using the income approach. The income approach uses valuation techniques to convert future amounts to a single present amount (discounted). Our measurement is based on the value indicated by current market expectations about those future amounts. The fair value estimate took into account our estimates of future incremental earnings that may be achieved upon regulatory approval, promotion, and distribution associated with the rights, and included estimated cash flows of approximately 10 years and a discount rate of approximately 25%. | |||||||||||||||||
The fair value of the contingent consideration liability assumed was determined using the probability of success and the discounted cash flow method of the income approach, which assumes that FDA approval of Captisol-enabled® 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. | |||||||||||||||||
We do not consider this acquisition to represent a material business combination; accordingly, we have not presented pro forma results of our combined operations that are otherwise required. | |||||||||||||||||
(c) Allos Acquisition | |||||||||||||||||
We acquired Allos Therapeutics, Inc. (“Allos”) on September 5, 2012, as discussed in Note 3 to our Annual Report on Form 10-K for the year ended December 31, 2012. |
Revolving_Line_of_Credit
Revolving Line of Credit | 9 Months Ended | ||||
Sep. 30, 2013 | |||||
Debt Disclosure [Abstract] | ' | ||||
Revolving Line of Credit | ' | ||||
9 | Revolving Line of Credit | ||||
In connection with the Allos acquisition, 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, as amended July 16, 2013 (the “Credit Agreement”). The Credit Agreement provides us with a committed $50.0 million revolving line of credit facility (the “Credit Facility”). The Credit Facility expires on September 5, 2014. | |||||
The Credit Facility bears interest, at our election, at a rate equal to the London Interbank Offer Rate, or LIBOR rate, or the base rate, plus an applicable margin (2.75% to 4.25%, dependent on a defined liquidity ratio). | |||||
We incurred $1.0 million in related loan costs and fees, which were deferred and will be amortized using the effective interest method over 24 months, the term of the Credit Facility. Amortization expense included in interest expense in the accompanying condensed consolidated statements of operations was $0.5 million and $40,000 for the nine months ended September 30, 2013 and 2012, respectively. | |||||
An unused line fee is payable quarterly in an amount ranging from 0.375% to 0.625% of the sum of the average daily unused portion of the facilities during any quarter based upon consolidated leverage ratio as at the last test date. A customary fee is also payable to the administrative agent on an annual basis in advance. Related interest expense for the unused line fee was $0.1 million for the nine months ended September 30, 2013. | |||||
Our direct and indirect domestic subsidiaries guaranty our obligations under the Credit Facility. The Credit Agreement includes the following quarterly financial covenants: | |||||
• | We may not permit the our consolidated interest coverage ratio as of the end of any fiscal quarter to be less than 3.00 to 1.00; | ||||
• | We may not permit the consolidated leverage ratio at any time set forth below to be greater than the ratio set forth below opposite such period: | ||||
Measurement Period Ending | Maximum | ||||
Consolidated | |||||
Leverage Ratio | |||||
Closing Date through September 30, 2012 | 2.00 to 1.00 | ||||
December 31, 2012 and each fiscal quarter thereafter | 1.50 to 1.00 | ||||
• | We may not permit the ratio of (i) the sum of (a) our unencumbered cash and cash equivalents on a consolidated basis, plus (b) our net accounts receivable on a consolidated basis, to (ii) consolidated funded indebtedness as of the end of any fiscal quarter to be less than 2.00 to 1.00. | ||||
In addition, the Credit Agreement includes certain negative covenants that, subject to exceptions, limit our ability to, among other things incur additional indebtedness, engage in future mergers, consolidations, liquidations and dissolutions, sell assets, pay dividends and distributions on or repurchase capital stock, and enter into or amend other material agreements. At September 30, 2013, we were in compliance with all financial covenants. |
Mundipharma_Agreement
Mundipharma Agreement | 9 Months Ended | ||||||||
Sep. 30, 2013 | |||||||||
Text Block [Abstract] | ' | ||||||||
Mundipharma Agreement | ' | ||||||||
10 | Mundipharma Agreement | ||||||||
As the result of Allos becoming our wholly-owned subsidiary, effective September 5, 2012, we assumed obligations under a strategic collaboration agreement with 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 the scope of the licensed territory and the respective development obligations. As a result, Europe and Turkey were excluded from Mundipharma’s commercialization territory, and royalty and milestone rates were modified. We may now also receive potential regulatory milestone payments of up to $16.0 million and commercial progress and sales-dependent milestone payments of up to $107.0 million. We will also receive tiered double- digit royalties based on net sales of FOLOTYN within Mundipharma’s licensed territories consistent with the terms of the original Munidpharma Collaboration Agreement. | |||||||||
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 to be performed by us. As part of the original Mundipharma Collaboration Agreement, we were obligated to perform research and development services related to jointly agreed-upon clinical development activities through approximately 2022. We recorded the fair value of the related deferred development cost obligation of $12.3 million as of September 5, 2012, using the discounted cash flow method of the income approach. This development cost liability was determined to be $18.7 million as of September 30, 2013 (inclusive of the $7.0 million payment from Mundipharma), which includes assumptions about our estimates of personnel needed to perform these research and development services, and expected third party costs for services and supplies for our projected clinical trial enrollment and patient treatment-related follow up time periods through approximately 2031. We will assess this liability at each subsequent reporting date and record its change within research and development expense in our Condensed Consolidated Statements of Operations. | |||||||||
Under the original Mundipharma Collaboration Agreement, Mundipharma was initially responsible for 40% of the joint development costs incurred by the parties, which increased to 50% upon the later of (i) the calendar quarter of the first approval of FOLOTYN in the EU for relapsed or refractory PTCL, and (ii) the first calendar quarter in which the development cost differential equals or exceeds $15.0 million. The “development cost differential” was defined as the cumulative amount of joint development costs that Mundipharma would have incurred if it was responsible for 50% of the joint development costs rather than its initial 40% share. To the extent that this development cost differential did not meet or exceed $15.0 million by December 31, 2019, then we were obligated to pay Mundipharma the difference between $15.0 million and the amount of the development cost differential as of December 31, 2019. | |||||||||
Research and development for the three and nine months ended September 30, 2013 included $-0- and $0.6 million, respectively, related to the 40% joint development cost reimbursement under the original Mundipharma Collaboration Agreement. The Amended Mundipharma Collaboration Agreement eliminated the development cost differential computation requirement. Prospectively, we and Mundipharma will bear our own development costs. | |||||||||
As of September 30, 2013 and December 31, 2012, deferred amounts related to the Mundipharma Agreements consisted of: | |||||||||
September 30, | December 31, | ||||||||
2013 | 2012 | ||||||||
Deferred development cost liability | $ | 3,251 | $ | 856 | |||||
Deferred development cost liability, less current portion | 15,400 | 11,377 | |||||||
Deferred payment contingency | — | 2,287 | |||||||
$ | 18,651 | $ | 14,520 | ||||||
Commitments_and_Contingencies
Commitments and Contingencies | 9 Months Ended | |
Sep. 30, 2013 | ||
Commitments And Contingencies Disclosure [Abstract] | ' | |
Commitments and Contingencies | ' | |
11 | Commitments and Contingencies | |
(a) Facility Lease | ||
We sublease our principal executive office in Henderson, Nevada under a non-cancelable operating lease expiring April 30, 2014. We also lease our research and development facility in Irvine, California under a non-cancelable operating lease expiring June 30, 2016. Each lease agreement contains certain scheduled rent increases which are accounted for on a straight-line basis. | ||
As part of our Irvine facility lease renewal in 2009, the landlord agreed to contribute up to approximately $1.5 million toward the cost of tenant improvements. The tenant improvements were completed in 2010 at an aggregate cost of approximately $1.4 million. This landlord contribution is being amortized on a straight-line basis over the term of the lease as a reduction to rent expense. We also lease small administrative offices in Colorado, New Jersey, Westlake Village (California), Tokyo, and Mumbai. | ||
(b) Licensing Agreements, Co-Development Agreements, and Milestone Payments | ||
We are developing almost all of our drug candidates pursuant to license agreements that provide us with rights in certain territories, among other things, to develop, sublicense, manufacture and sell the drugs. We are generally required to use commercially reasonable efforts to develop the drugs, and are generally responsible for all development, patent filing and maintenance, sales and marketing and liability insurance costs, and are generally contingently obligated to make milestone payments to the licensors if we successfully reach development and regulatory milestones specified in the license agreements. In addition, we are obligated to pay royalties and, in some cases, milestone payments based on net sales, if any, after marketing approval is obtained from regulatory authorities. | ||
The potential contingent development and regulatory milestone obligations under all of our licensing agreements are generally tied to progress through the various regulatory authorities’ approval process, which approval significantly depends on positive clinical trial results. The following items are typical of such milestone events: conclusion of Phase 2 or commencement of Phase 3 clinical trials; filing of new drug applications in each of the U.S., Europe and Japan; and approvals from each of the regulatory agencies in those jurisdictions. | ||
(i) ZEVALIN licensing and development in the United States | ||
In December 2008, we acquired rights to commercialize and develop ZEVALIN in the United States as the result of a transaction with Cell Therapeutics, Inc. (“CTI”). Pursuant to the transfer of the ZEVALIN assets from CTI to a joint venture, RIT Oncology LLC (“RIT”), in December 2008, RIT assumed certain agreements with various third parties related to ZEVALIN intellectual property. These currently effective agreements relate to the manufacture, use and sale of ZEVALIN in the United States and include (i) a license from Biogen, Idec, Inc. (“Biogen”) (ii) a license-back to Biogen for limited uses including fulfillment of a supply obligation to CTI, (iii) a sublicense from Biogen to certain ZEVALIN patents held by Genentech, Inc., (iv) a sublicense from Biogen to certain ZEVALIN patents held by GlaxoSmithKline and Glaxo Group Limited, and (v) a sublicense from Biogen to certain ZEVALIN patents held by Corixa Corporation, Coulter Pharmaceutical, Inc., The Regents of the University of Michigan and GlaxoSmithKline. | ||
In accordance with the terms of such agreements, RIT is required to meet specified payment obligations including a commercial milestone payment to Corixa Corporation of $5.0 million based on ZEVALIN sales in the United States, which has not been met as of September 30, 2013, as well as U.S. net sales-based royalties of low to mid-single digits to Genentech, Inc. and mid-single digits to Corixa Corporation. Such agreements generally continue until the last to expire of the licensed patents unless earlier terminated in accordance with the terms of the agreement. The patents that are subject to the agreements expire between 2014 and 2019. | ||
(ii) Asset Purchase Agreement between CTI and Biogen, ZEVALIN U.S. | ||
In connection with the joint venture arrangement with CTI, we entered into an amendment to the original asset purchase agreement between CTI and Biogen, referred to as the CTI/Biogen Agreement, modifying future milestone payments. Pursuant to the terms of the agreement, as amended, (i) upon the achievement of the specified FDA approval milestone, which was achieved in 2009, RIT (as successor to CTI) paid Biogen an additional amount of $5.5 million, (ii) RIT may be required to make an additional $10.0 million milestone payment upon the achievement of an additional FDA approval milestone, and (iii) RIT is required to make yearly royalty payments determined as a mid-single to mid-teen digits percentage of yearly net sales for the preceding year, increasing with the passage of time. The agreement has an indefinite term and is no longer subject to termination; provided, however, that the royalty obligations automatically terminate upon the latest to occur of expiration of the subject patents, the sale by a third party of a biosimilar product in the U.S. or December 31, 2015. CTI’s rights and obligations, including its payment obligations to Biogen for royalties on net sales of ZEVALIN and an additional regulatory milestone payment, under both the CTI/Biogen Agreement and the amendment were assigned to and assumed by RIT in connection with the closing of the joint venture transaction. | ||
(iii) License and Asset Purchase Agreement with Bayer Pharma, ZEVALIN Ex-U.S. | ||
On April 1, 2012, through a subsidiary, Spectrum Pharmaceuticals Cayman, L.P., we completed the acquisition of licensing rights to market ZEVALIN outside of the U.S., referred to as the ZEVALIN Ex-US Rights, from Bayer Pharma AG, or Bayer. Pursuant to the terms of the agreement, Spectrum acquired all rights including marketing, selling, intellectual property and access to existing inventory of ZEVALIN from Bayer. We currently market ZEVALIN in the U.S. and this agreement expands our commercial efforts to the rest of the world. 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, Spectrum paid Bayer a one-time fee of Euro 19 million or approximately $25.4 million, and 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., with specific rates subject to confidential treatment pursuant to an order by the SEC. Under the agreement, we also acquired access to existing inventory of ZEVALIN and concurrent with the closing, entered into certain ancillary agreements including but not limited to a transition services agreement to transition the business. Unless earlier terminated, the term of the agreement continues until the expiration of our royalty payment obligations which, in turn, run until the last-to-expire patent covering the sale of a licensed product in the relevant country or fifteen (15) years from the date of first commercial sale of the licensed product in such country, whichever is longer. This agreement may be terminated in the event of a material default, which is defined to include: (i) our failure to timely pay royalty payments under this agreement or payments under certain related agreements; (ii) our insolvency; and (iii) our breach and the resulting termination of an Amended and Restated License Agreement between Biogen and Bayer, dated as of January 16, 2012. | ||
(iv) Amended and Restated License Agreement with Merck & Cie AG, FUSILEV | ||
In May 2006, we amended and restated a license agreement with Merck & Cie AG, a Swiss corporation, which we assumed in connection with the acquisition of the assets of Targent. Pursuant to the license agreement with Merck & Cie, we obtained the exclusive license to use regulatory filings related to FUSILEV and a non-exclusive license under certain patents and know-how related to FUSILEV to develop, make, and have made, use, sell and have sold FUSILEV in the field of oncology in North America. In addition, we have the right of first opportunity to negotiate an exclusive license to manufacture, have manufactured, use and sell FUSILEV products outside the field of oncology in North America. Also, under the terms of the license agreement, we paid Merck & Cie $100,000 for the achievement of FDA approval of an injectable form of FUSILEV. Merck & Cie is also eligible to receive a $200,000 payment upon achievement of FDA approval of an oral form of FUSILEV, in addition to royalties in the mid-single digits based on a percentage of net sales. The term of the license agreement is determined on a product-by-product and country-by-country basis until royalties are no longer owed under the license agreement. The license agreement expires in its entirety after the date that we no longer owe any royalties to Merck & Cie. We have the unilateral right to terminate the license agreement, in its entirety or on a product-by-product or country-by-country basis, at any time for any reason and either party may terminate the license agreement due to material breach of the terms of the license agreement by or insolvency of the other party. | ||
(v) Asset Purchase Agreement with Targent, Inc., FUSILEV | ||
In March 2006, we entered into an Asset Purchase Agreement with Targent, Inc. (“Targent”). As part of the consideration for the purchase of certain assets, we agreed to pay milestone payments to Targent upon the achievement of certain regulatory events as well as for certain sales levels for FUSILEV within a calendar year. In connection with the achievement of the FDA approval milestone in April 2011, we issued an aggregate of 0.7 million shares of common stock to certain of Targent’s stockholders, as directed by Targent. We capitalized $6.3 million associated with this milestone as an intangible asset during 2011, which is being amortized over the estimated useful life of 8.7 years. | ||
In addition, in connection with the achievement of the first sales milestone of $40.0 million in May 2011 we issued 0.6 million shares of common stock to certain of Targent’s stockholders (which was equivalent value to approximately $5.0 million in cash), as directed by Targent. In September 2011, we achieved the second and final sales milestone of $100.0 million and paid $5.0 million in cash for an aggregate with the first sales milestone of $10.0 million. We capitalized the $10.0 million associated with these milestones as intangible assets. These intangible assets are being amortized over the estimated useful life of 8.6 years. As of December 2011, we have met all of the contractual milestones related to FUSILEV. | ||
(vi) License Agreement with Sloan-Kettering Institute, SRI International and Southern Research Institute, FOLOTYN | ||
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 effective September 5, 2012, on a consolidated basis 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, net of actual rebates, chargebacks and returns, or distributor sales, which may be different than our net product revenue recognized in accordance with U.S. generally accepted accounting principles, or GAAP, or sublicense revenues arising from sublicensing the product, if and when such sales or sublicenses occur. For purposes of the FOLOTYN License Agreement, annual worldwide sales consists of our distributor sales and annual net sales of FOLOTYN in the Mundipharma Territories, as reported to us under the Mundipharma Collaboration Agreement, if and when such sales occur in the Mundipharma Territories. Royalties are 8% of annual worldwide sales up to $150.0 million; 9% of annual worldwide sales of $150.0 million through $300.0 million; and 11% of annual worldwide sales in excess of $300.0 million. For the nine months ended September 30, 2013, our royalties were 8% of our net distributor sales. As of September 30, 2013, accrued royalties were $0.9 million and are included in “accounts payable and accrued obligations” on the accompanying Condensed Consolidated Balance Sheet. | ||
(vii) License Agreement with Cydex Pharmaceuticals, Inc., Captisol-enabled, Propyleneglycol-free Melphalan | ||
See Note 8(b) above. | ||
(viii) Exclusive Development and Commercialization Collaboration Agreement with Allergan, Apaziquone | ||
In October 2008, we signed 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 $41.5 million at closing and is obligated to make additional payments based on the achievement of certain development, regulatory and commercialization milestones. Under the terms of the original agreement, we were entitled to payment of $57.5 million and $245.0 million upon achievement of certain regulatory and commercialization milestones, respectively, of which $1.5 million has been achieved following completion of enrollment in clinical trials, per the terms of the license, development, supply and distribution agreement. Also, Allergan agreed to pay us tiered royalties starting in the mid-teens based on a percentage of net sales of Apaziquone outside of the U.S. and Asia, which specific rates are subject to confidential treatment pursuant to an order by the SEC. | ||
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 obligations for development, commercialization and other activities. As a result of the second amendment to the agreement with Allergan, Allergan has no remaining obligations to us, and we have no remaining performance obligations to them. However, we are obligated to pay Allergan a tiered single-digit royalty not to exceed mid-single digits based upon the net sales, when and if earned, of certain products containing Apaziquone in specified territories. Additionally, we are 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. | ||
(ix) Collaboration Agreement with Nippon Kayaku Co. LTD., Apaziquone | ||
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 Spectrum an upfront fee of $15.0 million and is obligated to make additional payments based on the achievement of certain development, regulatory and commercialization milestones. Under the terms of the agreement, we are entitled to payment of $10.0 million and $126.0 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. The agreement will remain in effect, on a country-by-country basis, until the expiration of the obligation of Nippon Kayaku to pay royalties on sales of the subject products in such country. | ||
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. In addition, we continue to evaluate whether the development milestones, none of which have been achieved to date, meet the remaining criteria to be considered substantive. As a result of our analysis, we consider our development milestones under the Nippon Kayaku license agreement to be substantive and, accordingly, we expect to recognize as revenue future payments received from such milestones only if and as each milestone is achieved. | ||
(x) Licensing and Collaboration Agreement with TopoTarget, belinostat | ||
In February 2010, we entered into a licensing and collaboration agreement with TopoTarget A/S (“TopoTarget”), for the development and commercialization of belinostat, pursuant to which we agreed to collaboration for the development and commercialization of belinostat. The agreement provides that we have the exclusive right to make, develop and commercialize belinostat in North America and India, with an option for China. The agreement also grants TopoTarget a co-promote option if and only if we do not maintain a minimum number (subject to adjustment for certain events outside of our control) of field personnel (as defined in the agreement) for a certain number of years post-approval of the PTCL indication. | ||
Under the terms of the agreement, all development, including studies, will be conducted under a joint development plan and in accordance with a mutually agreed upon target product profile provided that we have final decision-making authority for all developmental activities in North America and India (and China upon exercise of the option for China) and TopoTarget has final decision-making authority for all developmental activities in all other jurisdictions. We have agreed to assume all responsibility for and future costs of the ongoing registrational PTCL trial. We and TopoTarget will conduct future planned clinical trials pursuant to the joint development plan, of which we will fund 70% of the development costs and TopoTarget will fund 30% of the development costs. We and TopoTarget will each pay 50% of the costs for chemical, pharmaceutical and other process development related to the manufacturing of the product that are incurred with a mutually agreed upon budget in the joint development plan. TopoTarget is responsible for supplying us with both clinical and commercial product. | ||
Pursuant to the terms of this agreement, we paid TopoTarget an upfront fee of $30.0 million. In addition, on the successful achievement of certain development, regulatory and sales milestones, none of which have been achieved to date, we are obligated to issue 1.0 million shares of our common stock (subject to certain resale conditions) and pay TopoTarget up to $313.0 million. Also, we will pay TopoTarget royalties in the mid-teen digits based on net sales of the subject product in the defined territory. None of such royalties have been earned or paid since inception of the agreement. | ||
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. We may terminate this agreement with 180 days notice to TopoTarget. We may also terminate immediately upon a prohibition on the use of the subject product or clinical hold by the FDA. TopoTarget may also terminate immediately in the event of a challenge (without TopoTarget’s consent) by us of the patents that cover the product. | ||
(xi) Co-Development and Commercialization Agreement with Hanmi Pharmaceutical Company, SPI-2012 | ||
In late 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. In consideration for the rights granted to us under the co-development and commercialization agreement with Hanmi, we paid Hanmi a fee which is included in “research and development expense” in the accompanying Condensed Consolidated Statements of Operations because the technology has not yet achieved regulatory approval. Under the terms of the agreement, we will share the costs and expenses of the study with Hanmi, although we will have primary responsibility for them. If SPI-2012 is ultimately commercialized by us, we will have worldwide rights except for Korea, China and Japan upon payment of fees and milestone payments related to further development, regulatory approvals and sales targets. | ||
(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 costs of goods and services received, with such accruals based on factors such as estimates of work performed, patient enrollment, completion of patient studies and other events. We are in a position to accelerate, slow-down or discontinue any or all of the projects that we are working on at any given point in time. 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 and our future purchase obligations would reduce accordingly. | ||
(d) Supply Agreements | ||
In connection with our joint venture arrangement with CTI (see (b)(i) above), we entered into an amendment to the original supply agreement between Biogen and CTI, referred to as the CTI/Biogen Supply Agreement, modifying certain of the pricing and manufacturing technology transfer terms contained in the CTI/Biogen Supply Agreement and also providing that the term of the agreement may be shortened in some instances in the event of a mid-term manufacturing technology transfer. There are no milestone or royalty payments required pursuant to this agreement. The term of the agreement is until the manufacturing technology transfer is complete. | ||
(e) Employment Agreement | ||
We have entered into an employment agreement with Dr. Rajesh C. Shrotriya, our Chairman, President and Chief Executive Officer, which expires January 2, 2014. The employment agreement automatically renews for subsequent one-year calendar terms unless either party gives written notice of such party’s intent not to renew the agreement at least 90 days prior to the commencement of the new term. Payment and benefits would become payable to Dr. Shrotriya in the event of termination by us for any reason other than cause, upon a change in control of the Company, or by Dr. Shrotriya for good reason. | ||
(f) Deferred Compensation Plan | ||
On September 2, 2011, the Board of Directors approved the Spectrum Pharmaceuticals, Inc. Deferred Compensation Plan (the “Plan”). The Plan is intended to comply with the requirements of Section 409A of the Internal Revenue Code of 1986, as amended. The Plan is administered by the Compensation Committee of the board of directors, or a designee or designees of the Compensation Committee. The Plan is intended to be an unfunded plan which is maintained primarily to provide deferred compensation benefits for a select group of our employees including management, as selected by the Plan administrator (the “Participants”). Under the Plan, we provide the Participants with the opportunity to make annual elections to defer up to a specified amount or percentage of their eligible cash compensation, as established by the Plan administrator, and we have the option to make discretionary contributions. At September 30, 2013, deferrals and contributions totaling $3.7 million are included in “other accrued obligations” in the accompanying Condensed Consolidated Balance Sheet. | ||
(g) Litigation | ||
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 condensed consolidated results of operations, cash flows or financial condition. | ||
We are presently responding 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. 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 our 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. | ||
We from time-to-time are involved in other claims and legal proceedings of a nature considered normal and incidental to our business. These matters may include product liability, intellectual property, employment, and other general claims. | ||
Shareholder Litigation | ||
Mark J. Sherwin v. Spectrum Pharmaceuticals, Inc. (Filed September 3, 2013 in the Court of Chancery of the State of Delaware; Case Number 8858). The complaint seeks inspection of Spectrum’s books and records under Delaware Code section 220. Specifically, the complaint seeks inspection of books and records concerning whether Spectrum’s officers and directors breached their fiduciary duties by causing the Company to make false statements concerning the performance of FUSILEV. The complaint also seeks fees and costs. | ||
(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. |
Stockbased_Compensation
Stock-based Compensation | 9 Months Ended | ||||||||||||||||
Sep. 30, 2013 | |||||||||||||||||
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | ' | ||||||||||||||||
Stock-based Compensation | ' | ||||||||||||||||
12 | Stock-based Compensation | ||||||||||||||||
We record share-based employee compensation expense for all equity-based programs, including stock options, restricted stock grants, 401(k) plan matching, and our employee stock purchase plan. Total expense recorded for the three and nine month periods ended September 30, 2013 and 2012 is summarized below: | |||||||||||||||||
Three Months Ended | Nine months Ended | ||||||||||||||||
September 30, | September 30, | ||||||||||||||||
2013 | 2012 | 2013 | 2012 | ||||||||||||||
Research and development | $ | 283 | $ | 528 | $ | 1,152 | $ | 1,316 | |||||||||
Selling, general and administrative | 2,708 | 2,800 | 7,510 | 8,108 | |||||||||||||
Total share-based compensation expense | $ | 2,991 | $ | 3,328 | $ | 8,662 | $ | 9,424 | |||||||||
Income_Taxes
Income Taxes | 9 Months Ended | |
Sep. 30, 2013 | ||
Income Tax Disclosure [Abstract] | ' | |
Income Taxes | ' | |
13 | 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 (provision) for income taxes of $4.7 million and $10.2 million for the three and nine months ended September 30, 2013, respectively. Our ETR was 39% and 31% for the three and nine months ended September 30, 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. | ||
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. | ||
Based on the weight of both positive and negative evidence, we concluded that it is more likely than not that the domestic net deferred tax assets would be realized, and therefore, we released our domestic valuation allowance during the quarter ended March 31, 2012. We released $23.0 million as part of the projected annual effective tax rate and released the remaining $24.0 million of the domestic valuation allowance as a discrete item in the quarter ended March 31, 2012. We maintain a valuation allowance against our foreign net deferred tax assets as we continue to conclude it not more likely than not that the foreign net deferred tax assets will be realized. | ||
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 | 9 Months Ended | |
Sep. 30, 2013 | ||
Subsequent Events [Abstract] | ' | |
Subsequent Event | ' | |
14 | Subsequent Event | |
On October 3, 2013, we entered into an amendment (the “Topotarget Amendment”) to the License and Collaboration Agreement, dated February 2, 2010, as amended, by and between us and Topotarget. Under the Topotarget Amendment, among other things, we agreed to restructure the agreement to provide us with the right and the responsibility to manufacture (either through itself or one or more contract manufacturers) clinical, commercial and named patient supplies of Belinostat world-wide for an initial period from the amendment effective date through the date that is five years from the new drug application approval date and Topotarget being relieved of its existing responsibility regarding the same. Additionally, we agreed that Topotarget will purchase its requirements from us based on periodic forecasts and at cost plus percentage for such supplies. After the initial period, absent notices of termination, the supply arrangement shall continue for renewable periods. |
Description_of_Business_Basis_1
Description of Business, Basis of Presentation, and Operating Segment (Policies) | 9 Months Ended | |||
Sep. 30, 2013 | ||||
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 four drugs: | ||||
• | 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; and | |||
• | Marqibo® injection for patients in the U.S. with Philadelphia chromosome–negative acute lymphoblastic leukemia. | |||
We also have a diversified pipeline of product candidates in advanced-stage Phase 2 and Phase 3 studies. We have assembled an integrated in-house scientific team, including formulation development, clinical development, medical research, regulatory affairs, biostatistics and data management, and have established a commercial infrastructure for the marketing of our drug products. We also leverage the expertise of our worldwide partners to assist in the execution of our business strategies. | ||||
Basis of Presentation | ' | |||
(b) Basis of Presentation | ||||
The accompanying Condensed Consolidated Financial Statements in this Quarterly Report on Form 10-Q have been prepared in accordance with generally accepted accounting principles in the United States (“GAAP”) and the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”). These financial statements include the financial position, results of operations, and cash flows of the Company, including its wholly-owned subsidiaries. All inter-company accounts and transactions have been eliminated in consolidation. | ||||
We own fifty-percent of our Canadian affiliate, Spectrum Pharma Canada (“SPC”). We fund all of the expenses of this entity, and since we are deemed to be its “primary beneficiary” (as defined under applicable GAAP), SPC is reported in our financial statements as if it were a wholly-owned subsidiary. | ||||
On April 1, 2012, we acquired the licensing rights outside of the U.S to market ZEVALIN (the “ZEVALIN Rights”); on September 5, 2012 we acquired Allos Therapeutics, Inc. (“Allos”); and on July 17, 2013 we acquired Talon Therapeutics, Inc. (“Talon”). Our financial statements include the assets acquired, liabilities assumed, operating results and cash flows of these acquisitions, beginning with the respective acquisition date for each. | ||||
The unaudited condensed consolidated financial statements reflect all adjustments which are of a normal recurring nature (except for the correction of certain prior period immaterial errors, as discussed in Note 2). In the opinion of management, these adjustments are necessary to fairly state our financial position as of September 30, 2013, and the results of our operations and cash flows for the three and nine months ended September 30, 2013 and 2012. | ||||
The results of operations for the three and nine months ended September 30, 2013 are not necessarily indicative of the results that may be expected for the year ending December 31, 2013, or for any other periods. The unaudited financial statements included in this Quarterly Report on Form 10-Q do not include all disclosures required by GAAP for annual periods and should be read in conjunction with our audited financial statements for the year ended December 31, 2012, included in our Annual Report on Form 10-K. | ||||
Operating Segment | ' | |||
(c) Operating Segment | ||||
We have one reportable operating segment that is focused exclusively on developing and commercializing oncology and hematology drug products. For the three and nine months ended September 30, 2013 and 2012, 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 | ||||
Product Sales: We sell our products to wholesalers and distributors. Our wholesalers and distributors purchase our products and sell the products directly to end-users, such as clinics, hospitals, and private oncology-based practices. Revenue from product sales is recognized upon shipment of product 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 future returns. | |||
We calculate a provision for estimated product returns, sales discounts, rebates, government chargebacks, and distribution and data fees (collectively, “gross-to-net estimates”) – the nature of which is discussed within Note 2 to our 2012 Annual Report on Form 10-K. Our gross revenue is reduced by our gross-to-net estimates. We defer revenue recognition in full if/when these estimates are not reasonably determinable at the time of sale. | ||||
License Fees: We recognize license fees based on the terms of each contractual agreement. In general, this results in periodic revenue recognition as the third-party licensee has sales for which we are entitled to a royalty, or in certain cases, a lump-sum license fee in which revenue is recognized in that period. | ||||
Accounts Receivable | ' | |||
(ii) Accounts Receivable | ||||
Trade accounts receivable are recorded at the invoiced amount, 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 | ' | |||
(iii) Inventories | ||||
We value inventory at the lower of the actual cost to purchase or manufacture the inventory, or the market value for such inventory. 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. The provision is based on actual loss experience and a forecast of product demand compared to its remaining shelf life. | ||||
Goodwill and Intangible Assets | ' | |||
(iv) Goodwill and Intangible Assets | ||||
Goodwill represents the excess of acquisition cost over the fair value of the net assets of the acquired businesses. Goodwill has an indefinite useful life and is not amortized, but instead tested for impairment annually unless there are interim impairment indicators. We perform our annual evaluation as of October 1 each year. | ||||
We evaluate the recoverability of indefinite and definite lived intangible assets whenever events or changes in circumstances 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. | |||
Foreign Currency Translation | ' | |||
(v) Foreign Currency Translation | ||||
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 foreign currencies are included as a separate component of accumulated other comprehensive income (loss) in the statement of comprehensive income (loss). | ||||
We record foreign currency transactions at the exchange rate prevailing at the date of the transaction with resultant gains and losses being included in results of operations. Foreign currency transaction gains and losses have not been significant for any period presented. | ||||
Comprehensive Income (Loss) | ' | |||
(vi) Comprehensive Income (Loss) | ||||
Comprehensive income (loss) is calculated in accordance with authoritative guidance which requires the disclosure of all components of comprehensive income, including net income (loss) and changes in equity during a period from transactions and other events and circumstances generated from non-owner sources. Our accumulated other comprehensive income (loss) at September 30, 2013 and 2012, respectively consisted primarily of foreign currency translation adjustments and net unrealized gains/losses on investments in marketable securities as of each date. | ||||
Basic and Diluted Net Income (Loss) per Share | ' | |||
(vii) Basic and Diluted Net Income (Loss) per Share | ||||
We calculate basic and diluted net income (loss) per share using the weighted average number of common shares outstanding during the periods presented, and adjust the amount of net income (loss) used in this calculation for preferred stock dividends (if any) declared during the period. In periods of a net loss position, 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 dilutive stock options, warrants and other common stock equivalents outstanding during the period. | ||||
Income Taxes | ' | |||
(viii) Income Taxes | ||||
We record 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. We have recorded a valuation allowance to reduce our net deferred tax assets, because we believe that, based upon a weighting of positive and negative factors, it is more likely than not that these deferred tax assets will not be realized. If we were to determine that we would be able to realize our deferred tax assets in the future, an adjustment to the valuation allowance of our deferred tax assets would increase net income in the period such determination was made. In the event that we were assessed interest and/or penalties from taxing authorities, such amounts would be included in “income tax expense” within the Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) in the period the notice was received. | ||||
Research and Development Costs | ' | |||
(ix) Research and Development Costs | ||||
Research and development costs are expensed as incurred. | ||||
Fair Value Measurements | ' | |||
(x) Fair Value Measurements | ||||
We measure fair value based on the prices that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. 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 accessible at the measurement date. The fair value hierarchy gives the highest priority to Level 1 inputs. | ||||
Level 2: Observable prices that are based on inputs not quoted on active markets, but corroborated by market data. These inputs include quoted prices for similar assets or liabilities; quoted market prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. | ||||
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 equivalents” within our accompanying Condensed Consolidated Balance Sheets consist of bank deposits and certificates of deposit. Certificates of deposit are valued at cost, which approximates fair value due to the short-term maturities of these instruments. “Marketable securities” consist of U.S. Government treasury bills, U.S. treasury-backed securities, and corporate deposits, which are stated at fair value (utilizing Level 1 inputs). | ||||
The fair value of our “deferred development cost” liability and our “deferred payment contingency” within our accompanying Condensed Consolidated Balance Sheets was valued using a model commonly referred to as 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) internal 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. | ||||
“Other long-term obligations” within our accompanying Condensed Consolidated Balance Sheets represent future amounts we may be required to pay in conjunction with various business combinations (i.e., contingent consideration) – see Note 8(a) for a discussion of CVRs granted as part of our acquisition of Talon). The fair value of the liability associated with FDA approval of Captisol-enabled® melphalan (see Note 8(b)) is also included within “other long-term obligations”. These liabilities within our accompanying Condensed Consolidated Balance Sheets are valued using Level 3 inputs which include probabilities and assumptions related to the timing and likelihood of achievement of regulatory and sales milestones and other contractual performance conditions. These inputs are reviewed for reasonableness by management on at least a quarterly basis. |
Correction_of_Immaterial_Error1
Correction of Immaterial Errors Within Previously Issued Condensed Consolidated Financial Statements (Tables) | 9 Months Ended | ||||||||||||||||
Sep. 30, 2013 | |||||||||||||||||
Accounting Changes And Error Corrections [Abstract] | ' | ||||||||||||||||
Consolidated Balance Sheet | ' | ||||||||||||||||
Consolidated Balance Sheet for | |||||||||||||||||
Year Ended December 31, 2012 | |||||||||||||||||
As Reported | As Restated | ||||||||||||||||
Intangible assets, net | $ | 202,311 | $ | 200,234 | |||||||||||||
Goodwill | 28,973 | 7,279 | |||||||||||||||
Deferred tax assets | 12,473 | 23,276 | |||||||||||||||
Other assets | 7,569 | 6,745 | |||||||||||||||
Total assets | 506,274 | 504,955 | |||||||||||||||
Accounts payable and other accrued obligations | 95,297 | 93,811 | |||||||||||||||
Accrued drug development costs | 15,109 | 11,441 | |||||||||||||||
Total current liabilities | 128,397 | 123,243 | |||||||||||||||
Total liabilities | 221,428 | 216,274 | |||||||||||||||
Accumulated deficit | (179,320 | ) | (175,485 | ) | |||||||||||||
Total stockholders’ equity | 284,846 | 288,681 | |||||||||||||||
Condensed Consolidated Results of Operations | ' | ||||||||||||||||
Condensed Consolidated Results of Operations | |||||||||||||||||
Three Months | Three Months | Nine Months | Nine Months | ||||||||||||||
Ended | Ended | Ended | Ended | ||||||||||||||
September 30, | September 30, | September 30, | September 30, | ||||||||||||||
2012 | 2012 | 2012 | 2012 | ||||||||||||||
(As Reported) | (As Restated) | (As Reported) | (As Restated) | ||||||||||||||
Research and development | $ | 10,183 | $ | 10,019 | $ | 28,657 | $ | 27,838 | |||||||||
Selling, general and administrative | 23,114 | 22,925 | 64,723 | 64,230 | |||||||||||||
Total operating expenses | 46,286 | 45,933 | 129,182 | 127,870 | |||||||||||||
Income from operations | 22,756 | 23,109 | 68,421 | 69,733 | |||||||||||||
Income before provision for income taxes | 23,049 | 23,402 | 67,345 | 68,657 | |||||||||||||
(Provision) benefit for income taxes | (1,737 | ) | (1,878 | ) | 18,579 | 18,054 | |||||||||||
Net income | 21,312 | 21,524 | 85,924 | 86,711 | |||||||||||||
Net income per share, basic | $ | 0.36 | $ | 0.37 | $ | 1.47 | $ | 1.48 | |||||||||
Net income per share, diluted | $ | 0.33 | $ | 0.33 | $ | 1.32 | $ | 1.34 | |||||||||
Condensed Consolidated Statement of Cash Flows | ' | ||||||||||||||||
Condensed Consolidated Statement of Cash Flows | |||||||||||||||||
Nine Months Ended | Nine Months Ended | ||||||||||||||||
September 30, 2012 | September 30, 2012 | ||||||||||||||||
(As Reported) | (As Restated) | ||||||||||||||||
Net income | $ | 85,924 | $ | 86,711 | |||||||||||||
Changes in operating expenses and liabilities: | |||||||||||||||||
Accounts payable and other accrued obligations | 26,586 | 26,618 | |||||||||||||||
Accrued drug development costs | 1,565 | 746 | |||||||||||||||
Net cash provided by operating activities | 63,862 | 63,862 |
Balance_Sheet_Account_Detail_T
Balance Sheet Account Detail (Tables) | 9 Months Ended | ||||||||||||||||||||||||||||
Sep. 30, 2013 | |||||||||||||||||||||||||||||
Text Block [Abstract] | ' | ||||||||||||||||||||||||||||
Summary of Investments | ' | ||||||||||||||||||||||||||||
The following is a summary of such investments: | |||||||||||||||||||||||||||||
Amortized | Gross | Gross | Estimated | Cash | Marketable Security | ||||||||||||||||||||||||
Cost | Unrealized | Unrealized | fair | ||||||||||||||||||||||||||
Gains | Losses | Value | Current | Long | |||||||||||||||||||||||||
Term | |||||||||||||||||||||||||||||
September 30, 2013 | |||||||||||||||||||||||||||||
Cash and equivalents | $ | 71,974 | $ | — | $ | — | $ | 71,974 | $ | 71,974 | $ | — | $ | — | |||||||||||||||
Bank CDs (including restricted certificate of deposit of $250) | 252 | — | — | 252 | — | 252 | — | ||||||||||||||||||||||
Money market currency funds | 3,060 | — | — | 3,060 | — | 3,060 | — | ||||||||||||||||||||||
Other securities (included in other assets) | 1,747 | 1,407 | — | 3,154 | — | — | 3,154 | ||||||||||||||||||||||
Total investments | $ | 77,033 | $ | 1,407 | $ | — | $ | 78,440 | $ | 71,974 | $ | 3,312 | $ | 3,154 | |||||||||||||||
December 31, 2012 | |||||||||||||||||||||||||||||
Cash and equivalents | $ | 139,698 | $ | — | $ | — | $ | 139,698 | $ | 139,698 | $ | — | $ | — | |||||||||||||||
Bank CDs (including restricted certificate of deposit of $250) | 987 | — | — | 987 | — | 987 | — | ||||||||||||||||||||||
Money market currency funds | 2,323 | — | — | 2,323 | — | 2,323 | — | ||||||||||||||||||||||
Other securities (included in other assets) | 1,747 | 733 | — | 2,480 | — | — | 2,480 | ||||||||||||||||||||||
Total investments | $ | 144,755 | $ | 733 | $ | — | $ | 145,488 | $ | 139,698 | $ | 3,310 | $ | 2,480 | |||||||||||||||
Inventories, Net of Allowances | ' | ||||||||||||||||||||||||||||
Inventories, net of allowances consisted of the following: | |||||||||||||||||||||||||||||
September 30, | December 31, | ||||||||||||||||||||||||||||
2013 | 2012 | ||||||||||||||||||||||||||||
Raw materials | $ | 2,622 | $ | 887 | |||||||||||||||||||||||||
Work-in-process | 3,174 | 7,302 | |||||||||||||||||||||||||||
Finished goods | 8,846 | 6,289 | |||||||||||||||||||||||||||
$ | 14,642 | $ | 14,478 | ||||||||||||||||||||||||||
Components of Intangible Assets | ' | ||||||||||||||||||||||||||||
Intangible assets consist of the following: | |||||||||||||||||||||||||||||
September 30, 2013 | |||||||||||||||||||||||||||||
Gross | Accumulated | Foreign | Impairment | Net | |||||||||||||||||||||||||
Amount | Amortization | Currency | Amount | Amortization | |||||||||||||||||||||||||
Translation | Period (years) | ||||||||||||||||||||||||||||
Marqibo IPR&D | $ | 17,600 | $ | — | $ | — | $ | — | $ | 17,600 | n/a | ||||||||||||||||||
Marqibo developed technology | 26,900 | (508 | ) | — | — | 26,392 | 13 | ||||||||||||||||||||||
ZEVALIN marketing rights—U.S. | 41,900 | (22,525 | ) | — | — | 19,375 | 10 | ||||||||||||||||||||||
ZEVALIN marketing rights—Ex. U.S. | 23,490 | (4,501 | ) | 263 | — | 19,252 | 10 | ||||||||||||||||||||||
FUSILEV developed technology | 16,778 | (4,459 | ) | — | — | 12,319 | 9 | ||||||||||||||||||||||
FOLOTYN distribution rights* | 27,900 | (2,981 | ) | — | (1,023 | ) | 23,896 | 10 | |||||||||||||||||||||
FOLOTYN developed technology. | 118,400 | (8,308 | ) | — | — | 110,092 | 14 | ||||||||||||||||||||||
Melphalan IPR&D | 7,700 | — | — | — | 7,700 | n/a | |||||||||||||||||||||||
Total intangible assets | $ | 280,668 | $ | (43,282 | ) | $ | 263 | $ | (1,023 | ) | $ | 236,626 | |||||||||||||||||
* | On May 29, 2013, we amended our collaboration agreement 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., the FOLOTYN distribution rights). We determined that an impairment of the FOLOTYN distribution rights of $1.0 million resulted from the amendment and is recorded in the “amortization and impairment of intangible assets” in the accompanying Condensed Consolidated Statement of Operations for the nine months ended September 30, 2013. | ||||||||||||||||||||||||||||
Schedule of Goodwill | ' | ||||||||||||||||||||||||||||
Goodwill includes the following: | |||||||||||||||||||||||||||||
September 30, | December 31, | ||||||||||||||||||||||||||||
2013 | 2012 | ||||||||||||||||||||||||||||
(As Restated) | |||||||||||||||||||||||||||||
Acquisition of Zevalin Rights | 2,525 | 2,525 | |||||||||||||||||||||||||||
Acquisition of Allos | 5,346 | 4,791 | |||||||||||||||||||||||||||
Foreign exchange translation effects | 29 | (37 | ) | ||||||||||||||||||||||||||
$ | 7,900 | $ | 7,279 | ||||||||||||||||||||||||||
Schedule of Accounts Payable and Other Accrued Obligations | ' | ||||||||||||||||||||||||||||
Accounts payable and other accrued obligations consisted of the following: | |||||||||||||||||||||||||||||
September 30, | December 31, | ||||||||||||||||||||||||||||
2013 | 2012 | ||||||||||||||||||||||||||||
(As restated) | |||||||||||||||||||||||||||||
Trade payables | $ | 22,958 | $ | 30,814 | |||||||||||||||||||||||||
Allowance for rebates | 25,395 | 11,023 | |||||||||||||||||||||||||||
Accrued product royalty | 9,019 | 12,275 | |||||||||||||||||||||||||||
Allowance for returns | 2,636 | 5,056 | |||||||||||||||||||||||||||
Accrued data and distribution fees | 2,995 | 8,449 | |||||||||||||||||||||||||||
Accrued GPO administrative fees | 2,196 | 2,650 | |||||||||||||||||||||||||||
Inventory management fee | 784 | 3,050 | |||||||||||||||||||||||||||
Accrued income taxes | — | 2,522 | |||||||||||||||||||||||||||
Allowance for chargebacks | 4,559 | 15,153 | |||||||||||||||||||||||||||
Other accrued obligations | 778 | 2,819 | |||||||||||||||||||||||||||
$ | 71,320 | $ | 93,811 | ||||||||||||||||||||||||||
Grossto_Net_Product_Sales_Tabl
Gross-to Net Product Sales (Tables) | 9 Months Ended | ||||||||||||||||
Sep. 30, 2013 | |||||||||||||||||
Text Block [Abstract] | ' | ||||||||||||||||
Reconciliation of Gross to Net Product Sales | ' | ||||||||||||||||
The below table presents a gross-to-net product sales reconciliation for the three and nine months ended September 30, 2013 and 2012 is as follows: | |||||||||||||||||
Three Months Ended | Nine months Ended | ||||||||||||||||
September 30, | September 30, | ||||||||||||||||
2013 | 2012 | 2013 | 2012 | ||||||||||||||
Gross product sales | $ | 61,256 | $ | 91,805 | $ | 161,750 | $ | 279,075 | |||||||||
Government rebates and chargebacks | (15,136 | ) | (16,368 | ) | (46,219 | ) | (65,641 | ) | |||||||||
Data, distribution and GPO fees | (4,631 | ) | (7,898 | ) | (14,677 | ) | (21,369 | ) | |||||||||
Prompt pay discount | (50 | ) | (1,078 | ) | (155 | ) | (3,684 | ) | |||||||||
Product returns allowance | — | (590 | ) | 2,299 | (99 | ) | |||||||||||
Net product sales | $ | 41,439 | $ | 65,871 | $ | 102,998 | $ | 188,282 | |||||||||
Net_Income_Loss_Per_Share_Tabl
Net Income (Loss) Per Share (Tables) | 9 Months Ended | ||||||||||||
Sep. 30, 2013 | |||||||||||||
Earnings Per Share [Abstract] | ' | ||||||||||||
Basic and Diluted Net Income (Loss) Per Share Using Weighted Average Number of Common Shares Outstanding | ' | ||||||||||||
Net Loss | Weighted- | Net Loss | |||||||||||
Average | Per | ||||||||||||
Shares | Share | ||||||||||||
Outstanding | |||||||||||||
(Denominator) | |||||||||||||
Three Months Ended September 30, 2013 | |||||||||||||
Basic and diluted loss per share: | $ | (7,812 | ) | 61,903,242 | $ | (0.13 | ) | ||||||
The following table sets forth the number of shares excluded from the computation of diluted earnings per share, as their inclusion would be anti-dilutive: | |||||||||||||
September 30, | |||||||||||||
2013 | |||||||||||||
Preferred shares | 40,000 | ||||||||||||
Options | 2,881,993 | ||||||||||||
Incremental shares assumed issued on exercise of in the money warrants | 132,565 | ||||||||||||
Unvested restricted stock | 1,044,904 | ||||||||||||
4,099,288 | |||||||||||||
Net Income | Weighted- | Net Income | |||||||||||
Average | Per | ||||||||||||
Shares | Share | ||||||||||||
Outstanding | |||||||||||||
(Denominator) | |||||||||||||
Three Months Ended September 30, 2012 – As restated | |||||||||||||
Basic net income per share: | $ | 21,524 | 58,912,031 | $ | 0.37 | ||||||||
Diluted earnings per share: | |||||||||||||
Dilutive preferred shares | 40,000 | ||||||||||||
Dilutive options | 4,863,932 | ||||||||||||
Incremental shares assumed issued on exercise of in the money warrants | 279,518 | ||||||||||||
Unvested restricted stock | 1,044,125 | ||||||||||||
Diluted earnings per share | $ | 21,524 | 65,139,606 | $ | 0.33 | ||||||||
Potentially dilutive securities not included above since they were antidilutive: | |||||||||||||
Antidilutive options excluded from the calculation | 696,500 | ||||||||||||
Net Loss | Weighted- | Net Loss | |||||||||||
Average | Per | ||||||||||||
Shares | Share | ||||||||||||
Outstanding | |||||||||||||
(Denominator) | |||||||||||||
Nine Months Ended September 30, 2013 | |||||||||||||
Basic net loss per share: | $ | (22,762 | ) | 60,013,842 | $ | (0.38 | ) | ||||||
The following table sets forth the number of shares excluded from the computation of diluted earnings per share, as their inclusion would be anti-dilutive: | |||||||||||||
September 30, | |||||||||||||
2013 | |||||||||||||
Preferred shares | 40,000 | ||||||||||||
Options | 3,247,710 | ||||||||||||
Incremental shares assumed issued on exercise of in the money warrants | 160,486 | ||||||||||||
Unvested restricted stock | 1,044,904 | ||||||||||||
4,493,100 | |||||||||||||
Net Income | Weighted- | Net Income | |||||||||||
Average | Per | ||||||||||||
Shares | Share | ||||||||||||
Outstanding | |||||||||||||
(Denominator) | |||||||||||||
Nine Months Ended September 30, 2012 – As restated | |||||||||||||
Basic earnings per share: | $ | 86,711 | 58,564,176 | $ | 1.48 | ||||||||
Diluted earnings per share: | |||||||||||||
Dilutive preferred shares | 40,000 | ||||||||||||
Dilutive options | 4,959,558 | ||||||||||||
Incremental shares assumed issued on exercise of in the money warrants | 272,927 | ||||||||||||
Unvested restricted stock | 1,044,125 | ||||||||||||
Diluted earnings per share | $ | 86,711 | 64,880,786 | $ | 1.34 | ||||||||
Potentially dilutive securities not included above since they were antidilutive: | |||||||||||||
Antidilutive options excluded from the calculation | 737,230 | ||||||||||||
Fair_Value_Measurements_Tables
Fair Value Measurements (Tables) | 9 Months Ended | ||||||||||||||||
Sep. 30, 2013 | |||||||||||||||||
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 3(x)): | |||||||||||||||||
Fair Value Measurements | |||||||||||||||||
Level 1 | Level 2 | Level 3 | Total | ||||||||||||||
September 30, 2013 | |||||||||||||||||
Assets: | |||||||||||||||||
Cash and equivalents | $ | 71,974 | $ | — | $ | — | $ | 71,974 | |||||||||
Bank CDs (including restricted certificate of deposit of $250) | — | 252 | — | 252 | |||||||||||||
Money market currency funds | — | 3,060 | — | 3,060 | |||||||||||||
Cash and equivalents, and marketable securities and investments | 71,974 | 3,312 | — | 75,286 | |||||||||||||
Deferred compensation investments, including life insurance cash surrender value | — | 4,757 | — | 4,757 | |||||||||||||
Other securities | 3,154 | — | — | 3,154 | |||||||||||||
$ | 75,128 | $ | 8,069 | $ | — | $ | 83,197 | ||||||||||
Liabilities: | |||||||||||||||||
Deferred executive compensation liability | — | 3,721 | — | 3,721 | |||||||||||||
Deferred development costs | — | — | 18,651 | 18,651 | |||||||||||||
Melphalan license contingent consideration | — | — | 4,700 | 4,700 | |||||||||||||
Contingent value right | — | — | 6,500 | 6,500 | |||||||||||||
$ | — | $ | 3,721 | $ | 29,851 | $ | 33,572 | ||||||||||
Activity of Level 3 Inputs Measured on Recurring Basis | ' | ||||||||||||||||
The following summarizes the activity of Level 3 inputs measured on a recurring basis: | |||||||||||||||||
Fair Value Measurements of | |||||||||||||||||
Unobservable Inputs (Level 3) | |||||||||||||||||
Balance at December 31, 2011 | $ | — | |||||||||||||||
Transfers in / (out) of Level 3: | |||||||||||||||||
Deferred development costs | 12,233 | ||||||||||||||||
Deferred payment contingency | 2,287 | ||||||||||||||||
Balance at December 31, 2012 | 14,520 | ||||||||||||||||
Transfers in / (out) of Level 3: | |||||||||||||||||
Other long term liabilities | 4,700 | ||||||||||||||||
Deferred development costs | 6,418 | ||||||||||||||||
Deferred payment contingency | (2,287 | ) | |||||||||||||||
Contingent Value Right | 6,500 | ||||||||||||||||
Balance at September 30, 2013 | $ | 29,851 | |||||||||||||||
Business_Combinations_Tables
Business Combinations (Tables) | 9 Months Ended | ||||||||||||||||
Sep. 30, 2013 | |||||||||||||||||
Acquisition-Date Fair Value of Consideration Transferred | ' | ||||||||||||||||
The Talon acquisition purchase price was allocated to tangible and intangible assets acquired and liabilities assumed based upon their estimated fair value at the acquisition date. The following table summarizes the purchase price: | |||||||||||||||||
Cash consideration | $ | 11,300 | |||||||||||||||
Contingent value right | 6,500 | ||||||||||||||||
Spectrum shares of common stock | 26,300 | ||||||||||||||||
Total purchase consideration | $ | 44,100 | |||||||||||||||
Summary of Allocation of Total Purchase Price to Net Assets Acquired | ' | ||||||||||||||||
The following table summarizes the estimated fair value of the net assets acquired as of July 17, 2013: | |||||||||||||||||
Cash and equivalents | $ | 131 | |||||||||||||||
Inventory | 611 | ||||||||||||||||
Prepaid expenses and other current assets | 109 | ||||||||||||||||
Property and equipment | 30 | ||||||||||||||||
Deferred tax asset | 3,950 | ||||||||||||||||
Identifiable intangible assets | 44,500 | ||||||||||||||||
Total assets acquired | 49,331 | ||||||||||||||||
Accounts payable & accrued liabilities | 5,231 | ||||||||||||||||
Total liabilities assumed | 5,231 | ||||||||||||||||
Net assets acquired | $ | 44,100 | |||||||||||||||
Amortization Period for such Intangible Assets Acquired | ' | ||||||||||||||||
The acquired intangible assets consisted of developed technology and in-process research and development (“IPR&D”) for Marqibo treatment of acute lymphoblastic leukemia (“ALL”) and Marqibo treatment of non-Hodgkin’s lymphoma (“NHL”) as follows in the table below: | |||||||||||||||||
Value of | |||||||||||||||||
Intangible | Amortization | ||||||||||||||||
Assets | Period | ||||||||||||||||
Acquired | |||||||||||||||||
Developed technology —Marqibo for ALL | $ | 26,900 | 13 years | ||||||||||||||
IPR&D —Marqibo for NHL | 17,600 | (1 | ) | ||||||||||||||
Total identifiable intangible assets | $ | 44,500 | |||||||||||||||
-1 | IPR&D is an intangible asset classified as an indefinite-lived until the completion or abandonment of the associated research and development effort, and will be amortized over an estimated useful life to be determined at the date the project is completed. IPR&D is not amortized during this period, but rather tested for impairment. | ||||||||||||||||
Supplemental Pro Forma Financial Information | ' | ||||||||||||||||
The following unaudited pro forma financial information is presented to reflect the results of the Company’s consolidated operations for the three and nine months ended September 30, 2013 and 2012, as if the acquisition of Talon had occurred on January 1, 2012. To reflect the combined businesses, adjustments have been made to exclude one-time transaction costs and employee severance costs that were directly associated with the Talon acquisition. These pro forma results have been prepared for informational purposes only and may not be indicative of what operating results would have been, had the acquisition actually taken place on January 1, 2012, and may not be indicative of future operating results. | |||||||||||||||||
Three Months Ended | Nine months Ended | ||||||||||||||||
September 30, | September 30, | ||||||||||||||||
2013 | 2012 | 2013 | 2012 | ||||||||||||||
Pro Forma Total revenues | $ | 42,439 | $ | 69,042 | $ | 114,338 | $ | 197,603 | |||||||||
Pro Forma Cost of product sales | 8,221 | 11,155 | 22,271 | 31,402 | |||||||||||||
Pro Forma Total operating expenses | 53,026 | 51,633 | 140,911 | 133,570 | |||||||||||||
Pro Forma Net income (loss) | (5,112 | ) | 15,824 | (17,062 | ) | 81,011 | |||||||||||
Pro Forma Net income (loss) per share – basic | $ | (0.09 | ) | $ | 0.27 | $ | (0.29 | ) | $ | 1.38 | |||||||
Pro Forma Net income (loss) per share – diluted | $ | (0.09 | ) | $ | 0.24 | $ | (0.29 | ) | $ | 1.24 | |||||||
Talon Therapeutics, Inc. [Member] | ' | ||||||||||||||||
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 | |||||||||||||||
Contingent consideration | 4,700 | ||||||||||||||||
Total purchase consideration | $ | 7,700 | |||||||||||||||
Melphalan license [Member] | ' | ||||||||||||||||
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 | |||||||||||||||
Revolving_Line_of_Credit_Table
Revolving Line of Credit (Tables) | 9 Months Ended | ||||
Sep. 30, 2013 | |||||
Debt Disclosure [Abstract] | ' | ||||
Maximum Consolidated Leverage Ratio | ' | ||||
• | We may not permit the consolidated leverage ratio at any time set forth below to be greater than the ratio set forth below opposite such period: | ||||
Measurement Period Ending | Maximum | ||||
Consolidated | |||||
Leverage Ratio | |||||
Closing Date through September 30, 2012 | 2.00 to 1.00 | ||||
December 31, 2012 and each fiscal quarter thereafter | 1.50 to 1.00 |
Mundipharma_Agreement_Tables
Mundipharma Agreement (Tables) | 9 Months Ended | ||||||||
Sep. 30, 2013 | |||||||||
Text Block [Abstract] | ' | ||||||||
Deferred Amounts Related to Mundipharma Agreements | ' | ||||||||
As of September 30, 2013 and December 31, 2012, deferred amounts related to the Mundipharma Agreements consisted of: | |||||||||
September 30, | December 31, | ||||||||
2013 | 2012 | ||||||||
Deferred development cost liability | $ | 3,251 | $ | 856 | |||||
Deferred development cost liability, less current portion | 15,400 | 11,377 | |||||||
Deferred payment contingency | — | 2,287 | |||||||
$ | 18,651 | $ | 14,520 | ||||||
Stockbased_Compensation_Tables
Stock-based Compensation (Tables) | 9 Months Ended | ||||||||||||||||
Sep. 30, 2013 | |||||||||||||||||
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | ' | ||||||||||||||||
Share-Based Employee Compensation Expense | ' | ||||||||||||||||
Total expense recorded for the three and nine month periods ended September 30, 2013 and 2012 is summarized below: | |||||||||||||||||
Three Months Ended | Nine months Ended | ||||||||||||||||
September 30, | September 30, | ||||||||||||||||
2013 | 2012 | 2013 | 2012 | ||||||||||||||
Research and development | $ | 283 | $ | 528 | $ | 1,152 | $ | 1,316 | |||||||||
Selling, general and administrative | 2,708 | 2,800 | 7,510 | 8,108 | |||||||||||||
Total share-based compensation expense | $ | 2,991 | $ | 3,328 | $ | 8,662 | $ | 9,424 | |||||||||
Description_of_Business_Basis_2
Description of Business, Basis of Presentation, and Operating Segment - Additional Information (Detail) | 9 Months Ended |
Sep. 30, 2013 | |
Segment | |
Segment Reporting Information [Line Items] | ' |
Number of reportable operating segment | 1 |
Spectrum Pharma Canada [Member] | ' |
Segment Reporting Information [Line Items] | ' |
Canadian affiliate, percentage owned | 50.00% |
Correction_of_Immaterial_Error2
Correction of Immaterial Errors within Previously Issued Condensed Consolidated Financial Statements - Additional Information (Detail) (USD $) | Sep. 30, 2013 | Dec. 31, 2012 | Sep. 30, 2013 | Sep. 30, 2013 | Dec. 31, 2012 | Sep. 30, 2013 | Sep. 30, 2013 | Sep. 30, 2013 |
Research and development and sales and marketing activities [Member] | Research and development and sales and marketing activities [Member] | As Restated [Member] | Accounts Payable and Accrued Liabilities [Member] | Accounts Payable and Accrued Liabilities [Member] | Accounts Payable and Accrued Liabilities [Member] | |||
Liabilities as part of business combination [Member] | Research and development and sales and marketing activities [Member] | |||||||
Quantifying Misstatement in Current Year Financial Statements [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' |
Overstatement amount recorded in financial statement | ' | ' | ' | ' | ' | $7,700,000 | $1,000,000 | $6,700,000 |
Accumulated deficit | -198,241,000 | -175,485,000 | ' | ' | 7,200,000 | ' | ' | ' |
Reduction of selling general and administrative and research and development expenses | ' | ' | $100,000 | $500,000 | ' | ' | ' | ' |
Correction_of_Immaterial_Error3
Correction of Immaterial Errors Within Previously Issued Condensed Consolidated Financial Statements - Consolidated Balance Sheet (Detail) (USD $) | Sep. 30, 2013 | Dec. 31, 2012 | Dec. 31, 2012 | Sep. 30, 2012 | Dec. 31, 2012 | Sep. 30, 2012 |
In Thousands, unless otherwise specified | As Reported [Member] | As Reported [Member] | As Restated [Member] | As Restated [Member] | ||
Intangible assets, net | $236,626 | $200,234 | $202,311 | ' | $200,234 | ' |
Goodwill | 7,900 | 7,279 | 28,973 | ' | 7,279 | ' |
Deferred tax assets | 3,824 | 12,473 | 12,473 | ' | 23,276 | ' |
Other assets | 8,614 | 6,745 | 7,569 | ' | 6,745 | ' |
Total assets | 453,733 | 504,955 | 506,274 | ' | 504,955 | ' |
Accounts payable and other accrued obligations | 71,320 | 93,811 | 95,297 | 26,586 | 93,811 | 26,618 |
Accrued drug development costs | 10,580 | 11,441 | 15,109 | ' | 11,441 | ' |
Total current liabilities | 93,990 | 123,243 | 128,397 | ' | 123,243 | ' |
Total liabilities | 151,369 | 216,274 | 221,428 | ' | 216,274 | ' |
Accumulated deficit | -198,241 | -175,485 | -179,320 | ' | -175,485 | ' |
Total stockholders' equity | $302,364 | $288,681 | $284,846 | ' | $288,681 | ' |
Correction_of_Immaterial_Error4
Correction of Immaterial Errors Within Previously Issued Condensed Consolidated Financial Statements - Condensed Consolidated Results of Operations (Detail) (USD $) | 3 Months Ended | 9 Months Ended | ||
In Thousands, except Per Share data, unless otherwise specified | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 |
Research and development | $13,567 | $10,019 | $35,910 | $27,838 |
Selling, general and administrative | 29,003 | 22,925 | 73,601 | 64,230 |
Total operating expenses | 55,726 | 45,933 | 146,611 | 127,870 |
Income from operations | -13,287 | 23,109 | -32,273 | 69,733 |
Income before provision for income taxes | -12,545 | 23,402 | -33,011 | 68,657 |
(Provision) benefit for income taxes | -4,733 | 1,878 | -10,249 | -18,054 |
Net income | -7,812 | 21,524 | -22,762 | 86,711 |
Net income per share, basic | ($0.13) | $0.37 | ($0.38) | $1.48 |
Net income per share, diluted | ($0.13) | $0.33 | ($0.38) | $1.34 |
As Reported [Member] | ' | ' | ' | ' |
Research and development | ' | 10,183 | ' | 28,657 |
Selling, general and administrative | ' | 23,114 | ' | 64,723 |
Total operating expenses | ' | 46,286 | ' | 129,182 |
Income from operations | ' | 22,756 | ' | 68,421 |
Income before provision for income taxes | ' | 23,049 | ' | 67,345 |
(Provision) benefit for income taxes | ' | -1,737 | ' | 18,579 |
Net income | ' | 21,312 | ' | 85,924 |
Net income per share, basic | ' | $0.36 | ' | $1.47 |
Net income per share, diluted | ' | $0.33 | ' | $1.32 |
As Restated [Member] | ' | ' | ' | ' |
Research and development | ' | 10,019 | ' | 27,838 |
Selling, general and administrative | ' | 22,925 | ' | 64,230 |
Total operating expenses | ' | 45,933 | ' | 127,870 |
Income from operations | ' | 23,109 | ' | 69,733 |
Income before provision for income taxes | ' | 23,402 | ' | 68,657 |
(Provision) benefit for income taxes | ' | -1,878 | ' | 18,054 |
Net income | ' | $21,524 | ' | $86,711 |
Net income per share, basic | ' | $0.37 | ' | $1.48 |
Net income per share, diluted | ' | $0.33 | ' | $1.34 |
Correction_of_Immaterial_Error5
Correction of Immaterial Errors Within Previously Issued Condensed Consolidated Financial Statements - Condensed Consolidated Statement of Cash Flows (Detail) (USD $) | 3 Months Ended | 9 Months Ended | ||
In Thousands, unless otherwise specified | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | Dec. 31, 2012 |
Net income | $21,524 | ($22,762) | $86,711 | ' |
Changes in operating expenses and liabilities: | ' | ' | ' | ' |
Accounts payable and other accrued obligations | ' | 71,320 | ' | 93,811 |
Accrued drug development costs | ' | -861 | 746 | ' |
Net cash provided by operating activities | ' | -10,006 | 63,862 | ' |
As Reported [Member] | ' | ' | ' | ' |
Net income | 21,312 | ' | 85,924 | ' |
Changes in operating expenses and liabilities: | ' | ' | ' | ' |
Accounts payable and other accrued obligations | 26,586 | ' | 26,586 | 95,297 |
Accrued drug development costs | ' | ' | 1,565 | ' |
Net cash provided by operating activities | ' | ' | 63,862 | ' |
As Restated [Member] | ' | ' | ' | ' |
Net income | 21,524 | ' | 86,711 | ' |
Changes in operating expenses and liabilities: | ' | ' | ' | ' |
Accounts payable and other accrued obligations | 26,618 | ' | 26,618 | 93,811 |
Accrued drug development costs | ' | ' | 746 | ' |
Net cash provided by operating activities | ' | ' | $63,862 | ' |
Balance_Sheet_Account_Detail_A
Balance Sheet Account Detail - Additional Information (Detail) (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
Schedule Of Investments [Abstract] | ' | ' |
Cash, equivalents and marketable securities, including long term bank certificates of deposits, and investments, total | $78,400,000 | $145,500,000 |
Restricted certificates of deposit | $250,000 | $250,000 |
None of securities in a continuous unrealized loss position, period | 'One year | ' |
Balance_Sheet_Account_Detail_S
Balance Sheet Account Detail - Summary of Investments (Detail) (USD $) | Sep. 30, 2013 | Dec. 31, 2012 | Sep. 30, 2012 | Dec. 31, 2011 |
In Thousands, unless otherwise specified | ||||
Schedule of Investments [Line Items] | ' | ' | ' | ' |
Cash and cash equivalents, Amortized Cost | $71,974 | $139,698 | ' | ' |
Cash and cash equivalents, Marketable securities, Amortized Cost | 77,033 | 144,755 | ' | ' |
Cash and cash equivalents, Gross Unrealized Gains | ' | ' | ' | ' |
Cash and cash equivalents, Marketable securities, Gross Unrealized Gains | 1,407 | 733 | ' | ' |
Cash and cash equivalents, Gross Unrealized Losses | ' | ' | ' | ' |
Cash and cash equivalents, Marketable securities, Gross Unrealized Losses | ' | ' | ' | ' |
Cash and cash equivalents, Estimated fair Value | 71,974 | 139,698 | ' | ' |
Cash and cash equivalents, Marketable securities, Estimated fair Value | 78,440 | 145,488 | ' | ' |
Cash and cash equivalents | 71,974 | 139,698 | 143,283 | 121,202 |
Marketable Security, Current | 3,312 | 3,310 | ' | ' |
Marketable Security, Long Term | 3,154 | 2,480 | ' | ' |
Bank CDs [Member] | ' | ' | ' | ' |
Schedule of Investments [Line Items] | ' | ' | ' | ' |
Marketable security, Amortized Cost | 252 | 987 | ' | ' |
Marketable security, Gross Unrealized Gains | ' | ' | ' | ' |
Marketable security, Gross Unrealized Losses | ' | ' | ' | ' |
Marketable security, Estimated fair Value | 252 | 987 | ' | ' |
Cash and cash equivalents | ' | ' | ' | ' |
Marketable Security, Current | 252 | 987 | ' | ' |
Marketable Security, Long Term | ' | ' | ' | ' |
Money market currency funds [Member] | ' | ' | ' | ' |
Schedule of Investments [Line Items] | ' | ' | ' | ' |
Marketable security, Amortized Cost | 3,060 | 2,323 | ' | ' |
Marketable security, Gross Unrealized Gains | ' | ' | ' | ' |
Marketable security, Gross Unrealized Losses | ' | ' | ' | ' |
Marketable security, Estimated fair Value | 3,060 | 2,323 | ' | ' |
Cash and cash equivalents | ' | ' | ' | ' |
Marketable Security, Current | 3,060 | 2,323 | ' | ' |
Marketable Security, Long Term | ' | ' | ' | ' |
Other securities (included in other assets) [Member] | ' | ' | ' | ' |
Schedule of Investments [Line Items] | ' | ' | ' | ' |
Marketable security, Amortized Cost | 1,747 | 1,747 | ' | ' |
Marketable security, Gross Unrealized Gains | 1,407 | 733 | ' | ' |
Marketable security, Gross Unrealized Losses | ' | ' | ' | ' |
Marketable security, Estimated fair Value | 3,154 | 2,480 | ' | ' |
Cash and cash equivalents | ' | ' | ' | ' |
Marketable Security, Current | ' | ' | ' | ' |
Marketable Security, Long Term | $3,154 | $2,480 | ' | ' |
Balance_Sheet_Account_Detail_S1
Balance Sheet Account Detail - Summary of Investments (Parenthetical) (Detail) (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
In Thousands, unless otherwise specified | ||
Schedule Of Investments [Abstract] | ' | ' |
Restricted certificates of deposit | $250 | $250 |
Balance_Sheet_Account_Detail_I
Balance Sheet Account Detail - Inventories, Net of Allowances (Detail) (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
In Thousands, unless otherwise specified | ||
Inventory Disclosure [Abstract] | ' | ' |
Raw materials | $2,622 | $887 |
Work-in-process | 3,174 | 7,302 |
Finished goods | 8,846 | 6,289 |
Inventories, net | $14,642 | $14,478 |
Balance_Sheet_Account_Detail_C
Balance Sheet Account Detail - Components of Intangible Assets (Detail) (USD $) | 9 Months Ended | 6 Months Ended | 9 Months Ended | 1 Months Ended | 9 Months Ended | ||||||
In Thousands, unless otherwise specified | Sep. 30, 2013 | Dec. 31, 2012 | Sep. 30, 2013 | Sep. 30, 2013 | Sep. 30, 2013 | Sep. 30, 2013 | Sep. 30, 2013 | Sep. 30, 2013 | 29-May-13 | Sep. 30, 2013 | Sep. 30, 2013 |
FOLOTYN developed technology [Member] | Marqibo IPR&D [Member] | Marqibo developed technology [Member] | ZEVALIN marketing rights [Member] | ZEVALIN marketing rights [Member] | FUSILEV developed technology [Member] | FOLOTYN distribution rights [Member] | FOLOTYN distribution rights [Member] | Melphalan IPR&D [Member] | |||
U.S. [Member] | Ex. U.S. [Member] | ||||||||||
Product Rights [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Gross Amount | $280,668 | ' | ' | $17,600 | $26,900 | $41,900 | $23,490 | $16,778 | ' | $27,900 | $7,700 |
Gross Amount | ' | ' | 118,400 | ' | ' | ' | ' | ' | ' | ' | ' |
Accumulated Amortization | -43,282 | ' | ' | ' | -508 | -22,525 | -4,501 | -4,459 | ' | -2,981 | ' |
Accumulated Amortization | ' | ' | -8,308 | ' | ' | ' | ' | ' | ' | ' | ' |
Foreign Currency Translation | 263 | ' | ' | ' | ' | ' | 263 | ' | ' | ' | ' |
Foreign Currency Translation | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Impairment | -1,023 | ' | ' | ' | ' | ' | ' | ' | -1,023 | -1,023 | ' |
Net Amount | $236,626 | $200,234 | $110,092 | $17,600 | $26,392 | $19,375 | $19,252 | $12,319 | ' | $23,896 | $7,700 |
Amortization Period (years) | ' | ' | '14 years | ' | '13 years | '10 years | '10 years | '9 years | ' | '10 years | ' |
Balance_Sheet_Account_Detail_C1
Balance Sheet Account Detail - Components of Intangible Assets (Parenthetical) (Detail) (USD $) | 1 Months Ended | 9 Months Ended |
In Thousands, unless otherwise specified | 29-May-13 | Sep. 30, 2013 |
Product Rights [Line Items] | ' | ' |
Impairment | ' | $1,023 |
FOLOTYN distribution rights [Member] | ' | ' |
Product Rights [Line Items] | ' | ' |
Impairment | $1,023 | $1,023 |
Balance_Sheet_Account_Detail_S2
Balance Sheet Account Detail - Schedule of Goodwill (Detail) (USD $) | 9 Months Ended | 12 Months Ended |
In Thousands, unless otherwise specified | Sep. 30, 2013 | Dec. 31, 2012 |
Goodwill [Line Items] | ' | ' |
Foreign exchange translation effects | $29 | ($37) |
Goodwill | 7,900 | 7,279 |
ZEVALIN Rights [Member] | ' | ' |
Goodwill [Line Items] | ' | ' |
Acquisition | 2,525 | 2,525 |
Allos Therapeutics, Inc. [Member] | ' | ' |
Goodwill [Line Items] | ' | ' |
Acquisition | $5,346 | $4,791 |
Balance_Sheet_Account_Detail_S3
Balance Sheet Account Detail - Schedule of Accounts Payable and Other Accrued Obligations (Detail) (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
In Thousands, unless otherwise specified | ||
Payables And Accruals [Abstract] | ' | ' |
Trade payables | $22,958 | $30,814 |
Allowance for rebates | 25,395 | 11,023 |
Accrued product royalty | 9,019 | 12,275 |
Allowance for returns | 2,636 | 5,056 |
Accrued data and distribution fees | 2,995 | 8,449 |
Accrued GPO administrative fees | 2,196 | 2,650 |
Inventory management fee | 784 | 3,050 |
Accrued income taxes | ' | 2,522 |
Allowance for chargebacks | 4,559 | 15,153 |
Other accrued obligations | 778 | 2,819 |
Accounts payable and other accrued obligations | $71,320 | $93,811 |
Grossto_Net_Product_Sales_Reco
Gross-to Net Product Sales - Reconciliation of Gross to Net Product Sales (Detail) (USD $) | 3 Months Ended | 9 Months Ended | ||
In Thousands, unless otherwise specified | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 |
Sales Revenue Net [Abstract] | ' | ' | ' | ' |
Gross product sales | $61,256 | $91,805 | $161,750 | $279,075 |
Government rebates and chargebacks | -15,136 | -16,368 | -46,219 | -65,641 |
Data, distribution and GPO fees | -4,631 | -7,898 | -14,677 | -21,369 |
Prompt pay discount | -50 | -1,078 | -155 | -3,684 |
Product returns allowance | ' | -590 | 2,299 | -99 |
Net product sales | $41,439 | $65,871 | $102,998 | $188,282 |
Net_Income_Loss_Per_Share_Basi
Net Income (Loss) Per Share - Basic and Diluted Net Income (Loss) Per Share Using Weighted Average Number of Common Shares Outstanding (Detail) (USD $) | 3 Months Ended | 9 Months Ended | ||
In Thousands, except Share data, unless otherwise specified | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ' | ' | ' | ' |
Net income (loss) | ($7,812) | $21,524 | ($22,762) | $86,711 |
Weighted-Average Shares Outstanding (Denominator), Basic | 61,903,242 | 58,912,031 | 60,013,842 | 58,564,176 |
Dilutive preferred shares | 40,000 | ' | 40,000 | ' |
Dilutive options | 2,881,993 | ' | 3,247,710 | ' |
Incremental shares assumed issued on exercise of in the money warrants | 132,565 | ' | 160,486 | ' |
Unvested restricted stock | 1,044,904 | ' | 1,044,904 | ' |
Antidilutive options excluded from the calculation, Weighted-Average Shares Outstanding (Denominator) | 4,099,288 | ' | 4,493,100 | ' |
Weighted-Average Shares Outstanding (Denominator), Diluted | 61,903,242 | 65,139,606 | 60,013,842 | 64,880,786 |
Net Income Loss Per Share, Basic | ($0.13) | $0.37 | ($0.38) | $1.48 |
Net income per share, diluted | ($0.13) | $0.33 | ($0.38) | $1.34 |
As Restated [Member] | ' | ' | ' | ' |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ' | ' | ' | ' |
Net income (loss) | ' | $21,524 | ' | $86,711 |
Weighted-Average Shares Outstanding (Denominator), Basic | ' | 58,912,031 | ' | 58,564,176 |
Dilutive preferred shares | ' | 40,000 | ' | 40,000 |
Dilutive options | ' | 4,863,932 | ' | 4,959,558 |
Incremental shares assumed issued on exercise of in the money warrants | ' | 279,518 | ' | 272,927 |
Unvested restricted stock | ' | 1,044,125 | ' | 1,044,125 |
Weighted-Average Shares Outstanding (Denominator), Diluted | ' | 65,139,606 | ' | 64,880,786 |
Net Income Loss Per Share, Basic | ' | $0.37 | ' | $1.48 |
Net income per share, diluted | ' | $0.33 | ' | $1.34 |
As Restated [Member] | Antidilutive options [Member] | ' | ' | ' | ' |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ' | ' | ' | ' |
Antidilutive options excluded from the calculation, Weighted-Average Shares Outstanding (Denominator) | ' | 696,500 | ' | 737,230 |
Fair_Value_Measurements_Summar
Fair Value Measurements - Summary of Asset and Liability Fair Values (Detail) (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
In Thousands, unless otherwise specified | ||
Assets: | ' | ' |
Cash and equivalents | $71,974 | $139,698 |
Cash and equivalents, and marketable securities and investments | 75,286 | ' |
Deferred compensation investments, including life insurance cash surrender value | 4,757 | ' |
Other securities | 3,154 | ' |
Total Assets | 83,197 | ' |
Liabilities: | ' | ' |
Deferred executive compensation liability | 3,721 | ' |
Deferred development costs | 18,651 | ' |
Melphalan license contingent consideration | 4,700 | ' |
Contingent value right | 6,500 | ' |
Total Liabilities | 33,572 | ' |
Bank CDs [Member] | ' | ' |
Assets: | ' | ' |
Marketable securities, fair value | 252 | ' |
Money market currency funds [Member] | ' | ' |
Assets: | ' | ' |
Marketable securities, fair value | 3,060 | ' |
Level 1 [Member] | ' | ' |
Assets: | ' | ' |
Cash and equivalents | 71,974 | ' |
Cash and equivalents, and marketable securities and investments | 71,974 | ' |
Deferred compensation investments, including life insurance cash surrender value | ' | ' |
Other securities | 3,154 | ' |
Total Assets | 75,128 | ' |
Liabilities: | ' | ' |
Deferred executive compensation liability | ' | ' |
Deferred development costs | ' | ' |
Contingent value right | ' | ' |
Total Liabilities | ' | ' |
Level 1 [Member] | Bank CDs [Member] | ' | ' |
Assets: | ' | ' |
Marketable securities, fair value | ' | ' |
Level 1 [Member] | Money market currency funds [Member] | ' | ' |
Assets: | ' | ' |
Marketable securities, fair value | ' | ' |
Level 2 [Member] | ' | ' |
Assets: | ' | ' |
Cash and equivalents | ' | ' |
Cash and equivalents, and marketable securities and investments | 3,312 | ' |
Deferred compensation investments, including life insurance cash surrender value | 4,757 | ' |
Other securities | ' | ' |
Total Assets | 8,069 | ' |
Liabilities: | ' | ' |
Deferred executive compensation liability | 3,721 | ' |
Deferred development costs | ' | ' |
Contingent value right | ' | ' |
Total Liabilities | 3,721 | ' |
Level 2 [Member] | Bank CDs [Member] | ' | ' |
Assets: | ' | ' |
Marketable securities, fair value | 252 | ' |
Level 2 [Member] | Money market currency funds [Member] | ' | ' |
Assets: | ' | ' |
Marketable securities, fair value | 3,060 | ' |
Level 3 [Member] | ' | ' |
Assets: | ' | ' |
Cash and equivalents, and marketable securities and investments | ' | ' |
Deferred compensation investments, including life insurance cash surrender value | ' | ' |
Other securities | ' | ' |
Total Assets | ' | ' |
Liabilities: | ' | ' |
Deferred executive compensation liability | ' | ' |
Deferred development costs | 18,651 | ' |
Melphalan license contingent consideration | 4,700 | ' |
Contingent value right | 6,500 | ' |
Total Liabilities | 29,851 | ' |
Level 3 [Member] | Bank CDs [Member] | ' | ' |
Assets: | ' | ' |
Marketable securities, fair value | ' | ' |
Level 3 [Member] | Money market currency funds [Member] | ' | ' |
Assets: | ' | ' |
Marketable securities, fair value | ' | ' |
Fair_Value_Measurements_Summar1
Fair Value Measurements - Summary of Asset and Liability Fair Values (Parenthetical) (Detail) (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
In Thousands, unless otherwise specified | ||
Fair Value Disclosures [Abstract] | ' | ' |
Restricted certificate of deposit | $250 | $250 |
Fair_Value_Measurements_Activi
Fair Value Measurements - Activity of Level 3 Inputs Measured on Recurring Basis (Detail) (USD $) | 9 Months Ended | 12 Months Ended |
In Thousands, unless otherwise specified | Sep. 30, 2013 | Dec. 31, 2012 |
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ' | ' |
Ending Balance | $29,851 | $14,520 |
Deferred development costs [Member] | ' | ' |
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ' | ' |
Transfers in / (out) of Level 3 | 6,418 | 12,233 |
Deferred payment contingency [Member] | ' | ' |
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ' | ' |
Transfers in / (out) of Level 3 | -2,287 | 2,287 |
Other long term liabilities [Member] | ' | ' |
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ' | ' |
Transfers in / (out) of Level 3 | 4,700 | ' |
Contingent value right [Member] | ' | ' |
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ' | ' |
Transfers in / (out) of Level 3 | $6,500 | ' |
Business_Combinations_Addition
Business Combinations - Additional Information (Detail) (USD $) | 1 Months Ended | 3 Months Ended | 9 Months Ended |
Share data in Millions, except Per Share data, unless otherwise specified | Jul. 17, 2013 | Sep. 30, 2013 | Sep. 30, 2013 |
Business Acquisition [Line Items] | ' | ' | ' |
Cash consideration | ' | ' | $3,000,000 |
Milestone payments methods | 'If all sales and regulatory approval milestones were 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 | ' | ' |
Revenue derived from the former business | ' | 100,000 | 100,000 |
Direct costs of acquisition | ' | 5,700,000 | 5,700,000 |
License fees received | ' | ' | 3,000,000 |
Aggregate transaction costs expensed | ' | ' | 15,000 |
Milestone Payments [Member] | ' | ' | ' |
Business Acquisition [Line Items] | ' | ' | ' |
Milestone net sales achievement | 5,000,000 | ' | ' |
Milestone net sales achievement | 30,000,000 | ' | ' |
Milestone Payment One [Member] | ' | ' | ' |
Business Acquisition [Line Items] | ' | ' | ' |
Milestone net sales achievement | 10,000,000 | ' | ' |
Milestone net sales achievement | 60,000,000 | ' | ' |
Milestone Payment Two [Member] | ' | ' | ' |
Business Acquisition [Line Items] | ' | ' | ' |
Milestone net sales achievement | 25,000,000 | ' | ' |
Milestone net sales achievement | 100,000,000 | ' | ' |
Milestone Payment Three [Member] | ' | ' | ' |
Business Acquisition [Line Items] | ' | ' | ' |
Milestone net sales achievement | 50,000,000 | ' | ' |
Milestone net sales achievement | 200,000,000 | ' | ' |
Milestone Payment Four [Member] | ' | ' | ' |
Business Acquisition [Line Items] | ' | ' | ' |
Milestone net sales achievement | 100,000,000 | ' | ' |
Milestone net sales achievement | 400,000,000 | ' | ' |
Menadione Topical Lotion [Member] | ' | ' | ' |
Business Acquisition [Line Items] | ' | ' | ' |
Milestone net sales achievement | 5,000,000 | ' | ' |
In-process research and development [Member] | ' | ' | ' |
Business Acquisition [Line Items] | ' | ' | ' |
Estimated cash flow period | ' | ' | '10 years |
Estimated cash flow discount rate | ' | 25.00% | 25.00% |
Talon Therapeutics, Inc. [Member] | ' | ' | ' |
Business Acquisition [Line Items] | ' | ' | ' |
Securities purchase agreement date | 16-Jul-13 | ' | ' |
Additional shares business acquisition date | 17-Jul-13 | ' | ' |
Cash consideration | ' | ' | 11,300,000 |
Shares issued in acquisition | 3 | ' | ' |
Common stock value, per share | ' | ' | $8.77 |
Common stock value assigned | 26,300,000 | 26,300,000 | 26,300,000 |
Estimated fair value of acquisition | 6,500,000 | 6,500,000 | 6,500,000 |
Contingent value rights future cash payments | 195,000,000 | ' | ' |
Contingent value rights valuation description | 'The CVR was valued using a valuation model that probability-weights expected outcomes (ranging from 0% to 100%) and discounts those amounts to their present value, using a discount rate of 25% (these represent Level 3 inputs b see Note 3(x)). | ' | ' |
Contingent value rights discount rate | 25.00% | ' | ' |
Talon Therapeutics, Inc. [Member] | Minimum [Member] | ' | ' | ' |
Business Acquisition [Line Items] | ' | ' | ' |
Contingent value rights expected rate | 0.00% | ' | ' |
Talon Therapeutics, Inc. [Member] | Maximum [Member] | ' | ' | ' |
Business Acquisition [Line Items] | ' | ' | ' |
Contingent value rights expected rate | 100.00% | ' | ' |
Business_Combinations_Acquisit
Business Combinations - Acquisition-Date Fair Value of Consideration Transferred (Detail) (USD $) | 9 Months Ended | |
In Thousands, unless otherwise specified | Sep. 30, 2013 | Jul. 17, 2013 |
Business Acquisition [Line Items] | ' | ' |
Cash consideration | $3,000 | ' |
Captisol-enabled, propylene glycol-free melphalan rights [Member] | ' | ' |
Business Acquisition [Line Items] | ' | ' |
Cash consideration | 3,000 | ' |
Contingent consideration | 4,700 | ' |
Total purchase consideration | 7,700 | ' |
Talon Therapeutics, Inc. [Member] | ' | ' |
Business Acquisition [Line Items] | ' | ' |
Cash consideration | 11,300 | ' |
Contingent value right | 6,500 | 6,500 |
Spectrum shares of common stock | 26,300 | 26,300 |
Total purchase consideration | $44,100 | ' |
Business_Combinations_Summary_
Business Combinations - Summary of Allocation of Total Purchase Price to Net Assets Acquired (Detail) (USD $) | Sep. 30, 2013 |
In Thousands, unless otherwise specified | |
IPR&D - Captisol-enabled, propylene glycol-free melphalan rights [Member] | ' |
Loans At Acquisition Date [Line Items] | ' |
Total purchase price of net assets acquired | $7,700 |
Talon Therapeutics, Inc. [Member] | ' |
Loans At Acquisition Date [Line Items] | ' |
Cash and equivalents | 131 |
Inventory | 611 |
Prepaid expenses and other current assets | 109 |
Property and equipment | 30 |
Deferred tax asset | 3,950 |
Identifiable intangible assets | 44,500 |
Total assets acquired | 49,331 |
Accounts payable & accrued liabilities | 5,231 |
Total liabilities assumed | 5,231 |
Net assets acquired | 44,100 |
Total purchase price of net assets acquired | $44,100 |
Business_Combinations_Amortiza
Business Combinations - Amortization Period for such Intangible Assets Acquired (Detail) (USD $) | 9 Months Ended |
In Thousands, unless otherwise specified | Sep. 30, 2013 |
Talon Therapeutics, Inc. [Member] | ' |
Acquired Finite-Lived Intangible Assets [Line Items] | ' |
Total identifiable intangible assets | 44,500 |
Developed technology - Marqibo for ALL [Member] | ' |
Acquired Finite-Lived Intangible Assets [Line Items] | ' |
Amortization Period | '13 years |
Developed technology - Marqibo for ALL [Member] | Talon Therapeutics, Inc. [Member] | ' |
Acquired Finite-Lived Intangible Assets [Line Items] | ' |
Total identifiable intangible assets | 26,900 |
IPR&D - Marqibo for NHL [Member] | Talon Therapeutics, Inc. [Member] | ' |
Acquired Finite-Lived Intangible Assets [Line Items] | ' |
Total identifiable intangible assets | 17,600 |
Business_Combinations_Suppleme
Business Combinations - Supplemental Pro Forma Financial Information (Detail) (USD $) | 3 Months Ended | 9 Months Ended | ||
In Thousands, except Per Share data, unless otherwise specified | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 |
Business Combinations [Abstract] | ' | ' | ' | ' |
Pro Forma Total revenues | $42,439 | $69,042 | $114,338 | $197,603 |
Pro Forma Cost of product sales | 8,221 | 11,155 | 22,271 | 31,402 |
Pro Forma Total operating expenses | 53,026 | 51,633 | 140,911 | 133,570 |
Pro Forma Net income (loss) | ($5,112) | $15,824 | ($17,062) | $81,011 |
Pro Forma Net income (loss) per share - basic | ($0.09) | $0.27 | ($0.29) | $1.38 |
Pro Forma Net income (loss) per share - diluted | ($0.09) | $0.24 | ($0.29) | $1.24 |
Revolving_Line_of_Credit_Addit
Revolving Line of Credit - Additional Information (Detail) (USD $) | 9 Months Ended | |
Sep. 30, 2013 | Sep. 30, 2012 | |
Basis | ||
Line of Credit Facility [Line Items] | ' | ' |
Credit agreement revolving line of credit facility | $50,000,000 | ' |
Credit Facility expiry date | 5-Sep-14 | ' |
Credit facility, minimum interest rate | 2.75% | ' |
Credit facility, maximum interest rate | 4.25% | ' |
Loan costs and fees to be amortized using the effective interest method over 24 months | 1,000,000 | ' |
Amortization expense included in interest expense in the consolidated statement of income | 500,000 | 40,000 |
Percentage of maximum amount of unused line fee | 0.63% | ' |
Percentage of minimum amount of unused line fee | 0.38% | ' |
Fees relating to unused capacity | $100,000 | ' |
Applicable margin for credit facility based on consolidated interest coverage ratio, Maximum | 3 | ' |
Applicable margin for credit facility based on consolidated interest coverage ratio, Minimum | 1 | ' |
Maximum [Member] | ' | ' |
Line of Credit Facility [Line Items] | ' | ' |
Consolidated funded indebtedness | 2 | ' |
Minimum [Member] | ' | ' |
Line of Credit Facility [Line Items] | ' | ' |
Consolidated funded indebtedness | 1 | ' |
Revolving_Line_of_Credit_Maxim
Revolving Line of Credit - Maximum Consolidated Leverage Ratio (Detail) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2012 | Dec. 31, 2012 | |
Maximum [Member] | ' | ' |
Line of Credit Facility [Line Items] | ' | ' |
Consolidated Leverage Ratio | 2.00% | 1.50% |
Minimum [Member] | ' | ' |
Line of Credit Facility [Line Items] | ' | ' |
Consolidated Leverage Ratio | 1.00% | 1.00% |
Mundipharma_Agreements_Additio
Mundipharma Agreements - Additional Information (Detail) (USD $) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 05, 2012 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ' | ' | ' | ' | ' |
Company determined development payment | $55,726,000 | $45,933,000 | $146,611,000 | $127,870,000 | ' |
Deferred development cost | ' | ' | ' | ' | 12,300,000 |
License and contract revenue | 13,567,000 | 10,019,000 | 35,910,000 | 27,838,000 | ' |
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 | 18,700,000 | ' | 18,700,000 | ' | ' |
Portion of joint development costs incurred by the parties | ' | ' | 40.00% | ' | ' |
Potential portion of joint development costs incurred by the parties | ' | ' | 50.00% | ' | ' |
Mundipharma [Member] | Reimbursed joint development cost [Member] | ' | ' | ' | ' | ' |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ' | ' | ' | ' | ' |
Development cost differential, maximum payment | 15,000,000 | ' | 15,000,000 | ' | ' |
License and contract revenue | $0 | ' | $600,000 | ' | ' |
Mundipharma_Agreements_Deferre
Mundipharma Agreements - Deferred Amounts Related to Mundipharma Agreements (Detail) (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
In Thousands, unless otherwise specified | ||
Business Combination, Separately Recognized Transactions [Line Items] | ' | ' |
Deferred development cost liability | $3,251 | $856 |
Deferred development cost liability, less current portion | 15,400 | 11,377 |
Mundipharma [Member] | ' | ' |
Business Combination, Separately Recognized Transactions [Line Items] | ' | ' |
Deferred development cost liability | 3,251 | 856 |
Deferred development cost liability, less current portion | 15,400 | 11,377 |
Deferred payment contingency | ' | 2,287 |
Deferred amounts related to the agreements | $18,651 | $14,520 |
Commitments_and_Contingencies_
Commitments and Contingencies - Additional Information (Detail) | 1 Months Ended | 9 Months Ended | 1 Months Ended | 9 Months Ended | 1 Months Ended | 9 Months Ended | 1 Months Ended | 9 Months Ended | 1 Months Ended | 9 Months Ended | 12 Months Ended | 1 Months Ended | 12 Months Ended | 1 Months Ended | 9 Months Ended | ||||||||
Share data in Millions, unless otherwise specified | 31-May-06 | Sep. 30, 2013 | Dec. 31, 2012 | Apr. 30, 2012 | Apr. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2013 | Sep. 30, 2011 | Sep. 30, 2013 | Sep. 30, 2013 | 31-May-11 | Sep. 30, 2013 | Sep. 30, 2011 | Sep. 30, 2013 | Sep. 30, 2013 | Dec. 31, 2010 | Dec. 31, 2009 | Feb. 28, 2010 | 31-May-11 | Apr. 30, 2011 | Dec. 31, 2011 | Oct. 31, 2008 | Sep. 30, 2013 |
USD ($) | USD ($) | USD ($) | ZEVALIN [Member] | ZEVALIN [Member] | ZEVALIN [Member] | FOLOTYN [Member] | FUSILEV [Member] | Minimum [Member] | Minimum [Member] | Minimum [Member] | Maximum [Member] | Maximum [Member] | Henderson [Member] | Irvine [Member] | Irvine [Member] | Irvine [Member] | TopoTarget [Member] | Targent, Inc [Member] | Targent, Inc [Member] | Targent, Inc [Member] | Allergan [Member] | Nippon Kayaku [Member] | |
Licensing Agreements [Member] | Licensing Agreements [Member] | Licensing Agreements [Member] | USD ($) | USD ($) | FOLOTYN [Member] | FUSILEV [Member] | FOLOTYN [Member] | FUSILEV [Member] | USD ($) | USD ($) | USD ($) | USD ($) | USD ($) | USD ($) | USD ($) | ||||||||
USD ($) | EUR (€) | Country | USD ($) | USD ($) | USD ($) | USD ($) | |||||||||||||||||
Long-term Purchase Commitment [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Non cancelable operating lease expiring | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 30-Apr-14 | 30-Jun-16 | ' | ' | ' | ' | ' | ' | ' | ' |
Cost of tenant improvements, agreed | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | $1,500,000 | ' | ' | ' | ' | ' | ' |
Cost of tenant improvements, required | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 1,400,000 | ' | ' | ' | ' | ' | ' | ' |
Payment obligations including commercial milestone to Corixa Corporation | ' | 5,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Additional amount paid by RIT to Biogen | ' | 5,500,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Additional milestone payment upon the achievement of an additional FDA approval milestone | ' | 10,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Minimum number of countries outside U.S. approved ZEVALIN for treatment | ' | ' | ' | ' | ' | 40 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Fees paid to Bayer for acquiring licensing rights | ' | ' | ' | 25,400,000 | 19,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Payment to Merck & Cie for the achievement of FDA approval of FUSILEV | 100,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Amount receivable on approval of oral form of FUSILEV | 200,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Shares of common stock, issued | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 0.7 | ' | ' | ' |
Capitalization associated with milestone as intangible assets | ' | ' | ' | ' | ' | ' | ' | 10,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 6,300,000 | ' | ' |
Estimated useful life, amortized | ' | ' | ' | ' | ' | ' | ' | '8 years 7 months 6 days | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | '8 years 8 months 12 days | ' | ' |
First sales milestone | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 40,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Common stock issued, shares | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 0.6 | ' | ' | ' | ' |
Stock issued for the achievement of first sales milestone | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 5,000,000 | ' | ' | ' | ' |
Second and final sales milestone | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 100,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Cash paid for sales milestone achieved | ' | ' | ' | ' | ' | ' | ' | 5,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Aggregate amount received from first sales milestone | ' | ' | ' | ' | ' | ' | ' | 10,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Percentage of royalty on annual worldwide sales under condition one | ' | ' | ' | ' | ' | ' | 8.00% | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Percentage of royalty on annual worldwide sales under condition two | ' | ' | ' | ' | ' | ' | 9.00% | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Percentage of royalty on annual worldwide sales under condition three | ' | ' | ' | ' | ' | ' | 11.00% | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
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 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Percentage of royalties on net distributor sales | ' | ' | ' | ' | ' | ' | 8.00% | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Accrued royalties | ' | 9,019,000 | 12,275,000 | ' | ' | ' | 900,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Up-front non-refundable payment | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 41,500,000 | ' |
Additional payments based on the achievement of certain development | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 313,000,000 | ' | ' | ' | 245,000,000 | ' |
Payment related to agreement | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 57,500,000 | 10,000,000 |
Amount achieved following completion of enrollment in clinical trials | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 1,500,000 | ' |
Upfront fee | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 15,000,000 |
Payment on achievement of commercialization milestones | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 126,000,000 |
Percentage of development cost | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 70.00% | ' | ' | ' | ' | ' |
Percentage of development cost that is funded by TopoTarget for joint development plan | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 30.00% | ' | ' | ' | ' | ' |
Percentage of required payment to be paid for the cost incurred | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 50.00% | ' | ' | ' | ' | ' |
Upfront fee | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 30,000,000 | ' | ' | ' | ' | ' |
Shares of common stock, issued | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 1 | ' | ' | ' | ' | ' |
Notice period for termination of agreement | ' | '180 days | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Minimum days required to cancel employment agreement | ' | ' | ' | ' | ' | ' | ' | ' | '90 days | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Deferrals and contributions | ' | $3,700,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
StockBased_Compensation_ShareB
Stock-Based Compensation - Share-Based Employee Compensation Expense (Detail) (USD $) | 3 Months Ended | 9 Months Ended | ||
In Thousands, unless otherwise specified | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' | ' | ' |
Total share-based compensation expense | $2,991 | $3,328 | $8,662 | $9,424 |
Research and development [Member] | ' | ' | ' | ' |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' | ' | ' |
Total share-based compensation expense | 283 | 528 | 1,152 | 1,316 |
Selling, general and administrative expenses [Member] | ' | ' | ' | ' |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' | ' | ' |
Total share-based compensation expense | $2,708 | $2,800 | $7,510 | $8,108 |
Income_Taxes_Additional_Inform
Income Taxes - Additional Information (Detail) (USD $) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2013 | Sep. 30, 2012 | Mar. 31, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | |
Income Tax Disclosure [Abstract] | ' | ' | ' | ' | ' |
Benefit (provision) for income taxes | $4,733,000 | ($1,878,000) | ' | $10,249,000 | $18,054,000 |
Effective tax rate | 39.00% | ' | ' | 31.00% | ' |
U.S. federal statutory tax rate | ' | ' | ' | 35.00% | ' |
Valuation allowance projected annual effective tax rate change in amount | ' | ' | 23,000,000 | ' | ' |
Valuation allowance as a discrete item change in amount | ' | ' | $24,000,000 | ' | ' |