Document And Entity Information
Document And Entity Information - shares | 9 Months Ended | |
Sep. 30, 2015 | Oct. 29, 2015 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Oct. 2, 2015 | |
Document Fiscal Year Focus | 2,015 | |
Document Fiscal Period Focus | Q3 | |
Trading Symbol | exel | |
Entity Registrant Name | EXELIXIS, INC. | |
Entity Central Index Key | 939,767 | |
Entity Filer Category | Large Accelerated Filer | |
Current Fiscal Year End Date | --01-01 | |
Entity Common Stock, Shares Outstanding | 227,216,551 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2015 | Dec. 31, 2014 | [1] |
Current assets: | |||
Cash and cash equivalents | $ 145,642 | $ 80,395 | |
Short-term investments | 52,169 | 63,890 | |
Short-term restricted cash and investments | 0 | 12,212 | |
Trade and other receivables | 3,470 | 4,882 | |
Inventory | 2,121 | 2,381 | |
Prepaid expenses and other current assets | 3,949 | 3,481 | |
Total current assets | 207,351 | 167,241 | |
Long-term investments | 81,600 | 81,579 | |
Long-term restricted cash and investments | 2,650 | 4,684 | |
Property and equipment, net | 1,448 | 2,432 | |
Goodwill | 63,684 | 63,684 | |
Other assets | 6,508 | 8,340 | |
Total assets | 363,241 | 327,960 | |
Current liabilities: | |||
Accounts payable | 2,256 | 6,413 | |
Accrued clinical trial liabilities | 29,788 | 41,545 | |
Accrued compensation and benefits | 3,725 | 3,350 | |
Other accrued liabilities | 15,969 | 12,282 | |
Current portion of convertible notes | 450 | 98,880 | |
Current portion of loans payable | 0 | 381 | |
Current portion of restructuring | 3,734 | 6,426 | |
Deferred revenue | 0 | 2,583 | |
Total current liabilities | 55,922 | 171,860 | |
Long-term portion of convertible notes | 297,436 | 182,395 | |
Long-term portion of loans payable | 80,000 | 80,000 | |
Long-term portion of restructuring | 2,230 | 4,365 | |
Other long-term liabilities | 1,881 | 4,169 | |
Total liabilities | $ 437,469 | $ 442,789 | |
Commitments | |||
Stockholders’ deficit: | |||
Preferred stock | $ 0 | $ 0 | |
Common stock, $0.001 par value; 400,000,000 shares authorized; issued and outstanding: 226,154,354 and 195,895,769 shares at September 30, 2015 and December 31, 2014, respectively | 225 | 196 | |
Additional paid-in capital | 1,818,988 | 1,652,400 | |
Accumulated other comprehensive loss | (41) | (121) | |
Accumulated deficit | (1,893,400) | (1,767,304) | |
Total stockholders’ deficit | (74,228) | (114,829) | |
Total liabilities and stockholders’ deficit | $ 363,241 | $ 327,960 | |
[1] | The condensed consolidated balance sheet as of December 31, 2014 has been derived from the audited financial statements as of that date. |
Condensed Consolidated Balance3
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2015 | Dec. 31, 2014 |
Statement of Financial Position [Abstract] | ||
Common stock, par value, in dollars per share | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 400,000,000 | 400,000,000 |
Common stock, shares issued | 226,154,354 | 195,895,769 |
Common stock, shares outstanding | 226,154,354 | 195,895,769 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Revenues: | ||||
Net product revenues | $ 6,854 | $ 6,291 | $ 24,234 | $ 17,758 |
Contracts Revenue | 3,000 | 0 | 3,000 | 0 |
Total revenues | 9,854 | 6,291 | 27,234 | 17,758 |
Operating expenses: | ||||
Cost of goods sold | 1,420 | 573 | 2,872 | 1,359 |
Research and development | 26,091 | 43,628 | 72,879 | 149,451 |
Selling, general and administrative | 17,842 | 9,906 | 40,162 | 41,063 |
Restructuring charge | 282 | 3,758 | 1,142 | 4,135 |
Total operating expenses | 45,635 | 57,865 | 117,055 | 196,008 |
Loss from operations | (35,781) | (51,574) | (89,821) | (178,250) |
Other income (expense), net: | ||||
Interest income and other, net | 276 | 1,296 | 146 | 3,786 |
Interest expense | (12,059) | (12,282) | (36,421) | (36,125) |
Total other income (expense), net | (11,783) | (10,986) | (36,275) | (32,339) |
Net loss | $ (47,564) | $ (62,560) | $ (126,096) | $ (210,589) |
Net loss per share, basic and diluted, in dollars per share | $ (0.22) | $ (0.32) | $ (0.62) | $ (1.09) |
Shares used in computing basic and diluted net loss per share, in shares | 217,587 | 195,126 | 203,153 | 193,855 |
Condensed Consolidated Stateme5
Condensed Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | ||
Statement of Comprehensive Income [Abstract] | |||||
Net loss | $ (47,564) | $ (62,560) | $ (126,096) | $ (210,589) | |
Other comprehensive income (loss) | [1] | 133 | (153) | 80 | (122) |
Comprehensive loss | $ (47,431) | $ (62,713) | $ (126,016) | $ (210,711) | |
[1] | Other comprehensive income (loss) consisted solely of unrealized losses or gains, net on available for sale securities arising during the periods presented. There were no reclassification adjustments to net loss resulting from realized losses or gains on the sale of securities and there was no income tax expense related to other comprehensive income (loss) during those periods. |
Condensed Consolidated Stateme6
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | ||
Cash flows from operating activities: | |||
Net loss | $ (126,096) | $ (210,589) | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation and amortization | 1,063 | 3,014 | |
Stock-based compensation expense | 15,420 | 8,454 | |
Restructuring charge for property and equipment | 0 | 667 | |
Accretion of debt discount | 20,194 | 21,826 | |
Accrual of interest paid in kind | 1,890 | 0 | |
Gain on sale of business and other equity investment | (95) | (838) | |
Change in the fair value of warrants | 549 | (1,916) | |
Other | 1,338 | 3,602 | |
Changes in assets and liabilities: | |||
Trade and other receivables | 1,034 | (781) | |
Inventory | 259 | (986) | |
Prepaid expenses and other assets | (108) | (2,834) | |
Accounts payable, accrued compensation, and other accrued liabilities | (162) | (11,600) | |
Clinical trial liabilities | (11,757) | 10,144 | |
Restructuring liability | (5,731) | (2,705) | |
Other long-term liabilities | (1,367) | (756) | |
Deferred revenue | (2,583) | (131) | |
Net cash used in operating activities | (106,152) | (185,429) | |
Cash flows from investing activities: | |||
Purchases of property and equipment | (114) | (452) | |
Proceeds from sale of property and equipment | 1,300 | 286 | |
Proceeds from sale of business and other equity investment | 95 | 838 | |
Proceeds from maturities of restricted cash and investments | 16,754 | 20,397 | |
Purchase of restricted cash and investments | (2,616) | (8,184) | |
Proceeds from maturities of investments | 130,341 | 212,506 | |
Purchases of investments | (119,692) | (109,237) | |
Net cash provided by investing activities | 26,068 | 116,154 | |
Cash flows from financing activities: | |||
Proceeds from issuance of common stock, net | 145,651 | 75,646 | |
Proceeds from exercise of stock options and warrants | 3,787 | 120 | |
Proceeds from employee stock purchase plan | 274 | 929 | |
Principal payments on debt | (4,381) | (11,333) | |
Net cash provided by financing activities | 145,331 | 65,362 | |
Net increase (decrease) in cash and cash equivalents | 65,247 | (3,913) | |
Cash and cash equivalents at beginning of period | 80,395 | [1] | 103,978 |
Cash and cash equivalents at end of period | $ 145,642 | $ 100,065 | |
[1] | The condensed consolidated balance sheet as of December 31, 2014 has been derived from the audited financial statements as of that date. |
Organization and Summary of Sig
Organization and Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2015 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Summary of Significant Accounting Policies | ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Organization Exelixis, Inc. (“Exelixis,” “we,” “our” or “us”) is a biopharmaceutical company committed to developing small molecule therapies for the treatment of cancer. Our two most advanced assets are cabozantinib, our wholly-owned inhibitor of multiple receptor tyrosine kinases, and cobimetinib (GDC-0973/XL518), a selective inhibitor of MEK, a dual-specificity kinase, which we out-licensed to Genentech, Inc. (a member of the Roche Group), (“Genentech”). Our development and commercialization efforts are focused primarily on cabozantinib. Cabozantinib was approved by the United States Food and Drug Administration (“FDA”) on November 29, 2012, for the treatment of progressive, metastatic medullary thyroid cancer (“MTC”) in the United States under the brand name COMETRIQ ® . COMETRIQ became commercially available in the United States in January 2013. In March 2014, the European Commission granted cabozantinib conditional marketing authorization for the treatment of adult patients with progressive, unresectable locally advanced or metastatic MTC, also under the brand name COMETRIQ. We are evaluating cabozantinib in a broad development program comprising over 40 clinical trials across multiple indications, including ongoing phase 3 pivotal trials focusing on advanced renal cell carcinoma (“RCC”) and advanced hepatocellular carcinoma (“HCC”). In July 2015, we announced that the phase 3 pivotal trial for RCC met its primary endpoint of demonstrating a statistically significant increase in progression free survival (“PFS”) for cabozantinib, as determined by an independent radiology review committee. In August 2015 the FDA granted Breakthrough Therapy Designation for cabozantinib as a potential treatment for patients with advanced RCC. In October 2015, we initiated rolling submission of our U.S. New Drug Application (“NDA”) with the FDA. On November 10, 2015 , our second most advanced oncology asset, cobimetinib, was approved in the U.S. by the FDA under the brand name COTELLIC TM in combination with vemurafenib as a treatment for patients with BRAF V600 mutation-positive advanced melanoma. In Switzerland, cobimetinib in combination with vemurafenib was approved in August 2015 as a treatment for patients with BRAF V600 mutation-positive advanced melanoma. Roche also filed a Marketing Authorization Application for cobimetinib in combination with vemurafenib for the same indication with the European Medicines Agency and anticipates a regulatory decision before the end of 2015 following a positive opinion issued by the European Committee for Medicinal Products for Human Use, announced in late September 2015. Cobimetinib is subject to a collaboration agreement we entered into with Genentech in December 2006. Pursuant to the collaboration agreement’s financial terms, we believe that cobimetinib has the potential to provide us with a second significant source of revenue. Basis of Consolidation The consolidated financial statements include the accounts of Exelixis and those of our wholly-owned subsidiaries. These entities’ functional currency is the U.S. dollar. All intercompany balances and transactions have been eliminated. Basis of Presentation The accompanying unaudited consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States for interim financial information and pursuant to Form 10-Q and Article 10 of Regulation S-X of the Securities and Exchange Commission (“SEC”). Accordingly, they do not include all of the information and footnotes required by U.S. generally accepted accounting principles for complete financial statements. In our opinion, all adjustments (consisting only of normal recurring adjustments) considered necessary for a fair presentation of the results of operations and cash flows for the period presented have been included. Exelixis adopted a 52- or 53-week fiscal year that generally ends on the Friday closest to December 31st. Fiscal year 2015, a 52-week year, will end on January 1, 2016 , and fiscal year 2014, a 53-week year, ended on January 2, 2015 . For convenience, references in this report as of and for the fiscal periods ended October 2, 2015 and September 26, 2014 , and as of and for the fiscal years ended January 1, 2016 and January 2, 2015 , are indicated as being as of and for the periods ended September 30, 2015 , September 30, 2014 , December 31, 2015 , and December 31, 2014 , respectively. Operating results for the nine months ended September 30, 2015 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2015 or for any future period. These financial statements and notes should be read in conjunction with the consolidated financial statements and notes thereto for the year ended December 31, 2014 , included in our Annual Report on Form 10-K filed with the SEC on March 2, 2015 . Segment Information We operate as a single reportable segment. Use of Estimates The preparation of our consolidated financial statements is in conformity with accounting principles generally accepted in the United States which requires management to make judgments, estimates and assumptions that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosures. On an ongoing basis, management evaluates its estimates including, but not limited to, those related to inventory, revenue recognition, valuation of long-lived assets, certain accrued liabilities including clinical trial accruals and restructuring liability, valuation of warrants, share-based compensation and the valuation of the debt and equity components of our convertible debt at issuance. We base our estimates on historical experience and on various other market-specific and other relevant assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results could differ materially from those estimates. Need to Access Additional Capital We have incurred net losses since inception through September 30, 2015 , with the exception of the 2011 fiscal year. We anticipate net losses and negative operating cash flow for the foreseeable future. For the nine months ended September 30, 2015 , we incurred a net loss of $126.1 million and as of September 30, 2015 , we had an accumulated deficit of $1.9 billion . These losses have had, and will continue to have, an adverse effect on our stockholders’ deficit and working capital. Because of the numerous risks and uncertainties associated with developing drugs, we are unable to predict the extent of any future losses or whether or when we will become profitable, if at all. Our research and development expenditures and selling, general and administrative expenses have exceeded our revenues for each fiscal year other than the 2011 fiscal year, and we expect to spend significant additional amounts to fund the continued development and commercialization of cabozantinib. As a result, we expect to continue to incur substantial operating expenses and, consequently, we will need to generate significant additional revenues to achieve future profitability. We commercially launched COMETRIQ for the treatment of progressive, metastatic MTC in the United States in late January 2013 , and from the commercial launch through September 30, 2015 we have generated $64.4 million in net revenues from the sale of COMETRIQ. Other than revenues from COMETRIQ, we have derived substantially all of our revenues since inception from collaborative research and development agreements, which depend on research funding, the achievement of milestones, and royalties we earn from any future products developed from the collaborative research. The amount of our net losses will depend, in part, on: the rate of growth, if any, in our sales of COMETRIQ; our share of the net profits and losses for the commercialization for cobimetinib in the U.S., if any; the receipt of royalties from cobimetinib sales outside the U.S., if any; partnering activities for cabozantinib; other license and contract revenues; and, the level of expenses primarily with respect to development and commercialization activities for cabozantinib. As of September 30, 2015 , we had $282.1 million in cash and investments, which included $197.8 million available for operations, $81.6 million of compensating balance investments that we are required to maintain on deposit with Silicon Valley Bank, and $2.7 million of long-term restricted investments. We anticipate that our current cash and cash equivalents, and short-term investments available for operations, and product revenues, will enable us to maintain our operations for a period of at least 12 months following the end of the third quarter of 2015. While a forecast of future events is inherently uncertain, our ability to sustain our business operations for this time period without additional financing is highly dependent upon the commercial success of COMETRIQ and the revenues we generate, as well as the commercial success of COTELLIC and our share of related net profits and losses and royalties under our collaboration with Genentech. It is also dependent upon whether and when we partner cabozantinib with a global pharmaceutical organization for further development and sales outside the U.S., and the upfront payments and milestones associated with any such transaction. Consistent with the actions we have taken in the past, we will prioritize necessary and appropriate steps to ensure the continued operation of our business and preservation of the value of our assets. However, our future capital requirements will be substantial, and we may need to raise additional capital in the future. Our capital requirements will depend on many factors, and we may need to use available capital resources and raise additional capital significantly earlier than we currently anticipate. Revenue Recognition We recognize revenue from the sale of COMETRIQ and have historically recognized revenue from license fees and milestones earned on research and collaboration arrangements. During the three months ended September 30, 2015 , we recognized $3.0 million in contract revenues from a milestone payment received from Merck related to its worldwide license of our PI3K-delta program. See “Note 1 - Organization and Summary of Significant Accounting Policies” to our Consolidated Financial Statements included in our Annual Report on Form 10-K for the year ended December 31, 2014 for a description of our policies for revenue recognition on research and collaboration agreements. We did not enter into any new collaboration agreements during the nine months ended September 30, 2015 . See “Note 2 - Research and Collaboration Agreements” to our Consolidated Financial Statements included in our Annual Report on Form 10-K for the year ended December 31, 2014 for a description of our existing collaboration agreements. Net Product Revenues We recognize revenue when it is both realized or realizable and earned, meaning persuasive evidence of an arrangement exists, delivery has occurred, title has transferred, the price is fixed or determinable, there are no remaining customer acceptance requirements, and collectability of the resulting receivable is reasonably assured. For product sales in the United States, this generally occurs upon delivery of the product to the specialty pharmacy. For product sales in Europe, this generally occurs when our European distribution partner has accepted the product, at which time they are no longer able to return the product. We sell our product, COMETRIQ, in the United States to a specialty pharmacy that benefits from customer incentives and has a right of return. Prior to 2015, COMETRIQ had limited sales history and we could not reliably estimate expected future returns, discounts and rebates of the product at the time the product was sold to the specialty pharmacy, therefore we recognized revenue when the specialty pharmacy provided the product to a patient based on the fulfillment of a prescription, frequently referred to as the “sell-through” revenue recognition model. Recently we have established sufficient historical experience and data to reasonably estimate expected future returns of the product and the discounts and rebates due to payors at the time of shipment to the specialty pharmacy. Accordingly, beginning in January 2015 we began to recognize revenue upon delivery to our U.S. specialty pharmacy. This approach is frequently referred to as the “sell-in” revenue recognition model. In connection with the change in the timing of recognition of U.S. COMETRIQ sales, we recorded a one-time adjustment to recognize revenue and related costs that had previously been deferred at December 31, 2014, resulting in additional gross product revenues of $2.6 million and a nominal amount of cost of goods sold for the nine months ended September 30, 2015 ; there were no such adjustments recorded for the three months ended September 30, 2015 or during the comparable periods in 2014. We also utilize the “sell-in” revenue recognition model for sales to our European distribution partner for all periods presented. Once the European distributer has accepted the product, the product is no longer subject to return; therefore, we record revenue at the time our European distribution partner has accepted the product. Product Sales Discounts and Allowances We calculate gross product revenues based on the price that we charge our United States specialty pharmacy and our European distribution partner. We estimate our domestic net product revenues by deducting from our gross product revenues (a) trade allowances, such as discounts for prompt payment, (b) estimated government rebates and chargebacks, and (c) estimated costs of patient assistance programs. Discounts and allowances for foreign sales for the nine months ended September 30, 2015 and three and nine months ended September 30, 2014 included portions of a one-time $2.4 million project management fee payable to our European distribution partner upon its achievement of a cumulative revenue goal. During the three months ended September 30, 2014, we determined that the achievement of the revenue goal was probable and therefore we recorded $1.8 million of the project management fee. $1.0 million of the $1.8 million we recorded during the three months ended September 30, 2014 represented amounts that would have been previously recorded had the cumulative revenue goal been determined to be probable in those periods. During the nine months ended September 30, 2015 we recorded an additional $0.1 million of the project management fee; no such fees were recognized within product sales during the three months ended September 30, 2015 . We also deduct from gross product revenues an estimated credit for product originally delivered with expiry of 18 months or less that is potentially payable to our European distribution partner; such deductions were nominal during the three and nine months ended September 30, 2015 and 2014. We initially record estimates for these deductions at the time we recognize the gross revenue. We update our estimates on a recurring basis as new information becomes available. See “Note 1 - Organization and Summary of Significant Accounting Policies” to our Consolidated Financial Statements included in our Annual Report on Form 10-K for the year ended December 31, 2014 for a further description of our discounts and allowances. Cost of Goods Sold Cost of goods sold is related to our product revenues and consists primarily of a 3% royalty on net sales of any product incorporating cabozantinib payable to GlaxoSmithKline, and to a lesser extent, indirect labor costs, the cost of manufacturing, write-downs related to expiring and excess inventory, and other third party logistics costs of our product. A portion of the manufacturing costs for product sales were incurred prior to regulatory approval of COMETRIQ for the treatment of progressive, metastatic MTC and, therefore, were expensed as research and development costs when those costs were incurred, rather than capitalized as inventory. See “Note 2 - Research and Collaboration Agreements” to our Consolidated Financial Statements included in our Annual Report on Form 10-K for the year ended December 31, 2014 for additional information related to the 3% royalty payable to GlaxoSmithKline. Recently Issued Accounting Pronouncements In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2014-09, Revenue from Contracts with Customers (“ASU 2014-09”). ASU 2014-09 supersedes the revenue recognition requirements of FASB Accounting Standards Codification (“ASC”) Topic 605, Revenue Recognition and most industry-specific guidance throughout the Accounting Standards Codification, resulting in the creation of FASB ASC Topic 606, Revenue from Contracts with Customers . ASU 2014-09 requires entities to recognize revenue in a way that depicts the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled to in exchange for those goods or services. On July 9, 2015, the FASB deferred the effective date by one year for public entities for annual and interim reporting periods beginning after December 15, 2017. Early adoption is permitted for periods after December 15, 2016. We are currently evaluating the impact of adopting ASU 2014-09, inclusive of available transitional methods on our consolidated financial statements and related disclosures. In August 2014, the FASB issued ASU No. 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern (“ ASU 2014-15”) . ASU 2014-15 explicitly requires management to evaluate, at each annual or interim reporting period, whether there are conditions or events that exist that raise substantial doubt about an entity’s ability to continue as a going concern within one year after the date the financial statements are issued and to provide related disclosures. ASU 2014-15 is effective for annual periods ending after December 15, 2016 and earlier application is permitted. The adoption of this guidance will not have any impact on the Company’s financial position and results of operations and, at this time, we do not expect any impact on its disclosures. In April 2015, the FASB issued Accounting Standards Update No. 2015-03, Simplifying the Presentation of Debt Issuance Costs which Changes the Presentation of Debt Issuance Costs in Financial Statements (“ASU 2015-03”), which requires an entity to present such costs in the balance sheet as a direct deduction from the related debt liability rather than as an asset. Amortization of the costs will continue to be reported as interest expense. ASU 2015-03 will be effective for annual reporting periods beginning after December 15, 2015 and interim periods within fiscal years beginning after December 15, 2016, with early adoption permitted. The new guidance will be applied retrospectively to each prior period presented. If we had adopted ASU 2015-03, as of September 30, 2015 , it would have resulted in a reduction of Other assets and total debt by $3.5 million and $4.7 million as September 30, 2015 and December 31, 2014, respectively. |
Restructurings
Restructurings | 9 Months Ended |
Sep. 30, 2015 | |
Restructuring Charges [Abstract] | |
Restructurings | RESTRUCTURINGS The restructuring charges that we expect to incur in connection with our restructurings are subject to a number of assumptions, including facility exit activity, sublease activity, the results of asset sales and the timing of employee terminations, and actual results may materially differ. 2014 Restructuring On September 2, 2014, as a consequence of the failure of COMET-1, one of our two phase 3 pivotal trials of cabozantinib in metastatic castration-resistant prostate cancer, we initiated the 2014 Restructuring to reduce our workforce. Personnel reductions were initiated across our entire organization that resulted in an aggregate reduction in headcount of 143 full-time employees as of September 30, 2015 . The principal objective of the 2014 Restructuring was to enable us to focus our financial resources on the phase 3 pivotal trials of cabozantinib in advanced RCC and advanced HCC. For the nine months ended September 30, 2015 and 2014 , we recorded restructuring charges of $0.5 million and $3.3 million , respectively, for the 2014 Restructurings. The restructuring charge for the nine months ended September 30, 2015 included $1.5 million in additional charges due to the partial termination of one of our building leases and additional facility-related charges related to the decommissioning and exit of certain buildings. The restructuring charge for the nine months ended September 30, 2015 was partially offset by $0.9 million in recoveries recorded in connection with the sale of excess equipment and other assets. The restructuring charge for the nine months ended September 30, 2014 includes $2.6 million of employee severance and other benefits that are recognized ratably during the period from the implementation date of the 2014 Restructuring through the employees’ termination dates. In addition, during the nine months ended September 30, 2014 we recorded $0.7 million of property and equipment write-downs. Employee severance and other benefits are recognized ratably during the period from the implementation date of the 2014 Restructuring through the employees’ termination dates. The restructuring liability related to the 2014 Restructuring is included in the current and long-term portion of restructuring on the accompanying Consolidated Balance Sheets. The components of and changes to these liabilities during the nine months ended September 30, 2015 are summarized in the following table (in thousands): Employee Severance and Other Benefits Facility Asset Sales Legal and Other Fees Total Restructuring liability as of December 31, 2014 $ 1,290 $ — $ — $ 47 $ 1,337 Restructuring charge (recovery) (150 ) 1,542 (905 ) — 487 Cash (payments) receipts, net (1,021 ) (1,020 ) 1,284 — (757 ) Other non-cash items — 278 (379 ) 3 (98 ) Restructuring liability as of September 30, 2015 $ 119 $ 800 $ — $ 50 $ 969 We expect to pay the accrued facility charges of $0.8 million through April 2017. 2010 Restructurings Between March 2010 and May 2013, we implemented five restructurings (referred to collectively as the “2010 Restructurings”) to manage costs and as a consequence of our decision in 2010 to focus our proprietary resources and development efforts on the development and commercialization of cabozantinib. The aggregate reduction in headcount from the 2010 Restructurings was 429 employees. Charges and recoveries related to the 2010 Restructurings were recorded in periods other than those in which the 2010 Restructurings were implemented as a result of sublease activities for certain of our buildings in South San Francisco, California, changes in assumptions regarding anticipated sublease activities, the effect of the passage of time on our discounted cash flow computations, previously planned employee terminations, and sales of excess equipment and other assets. For the nine months ended September 30, 2015 and 2014 , we recorded restructuring charges of $0.7 million and $0.8 million , respectively, for the 2010 Restructurings. The charges for both periods presented were related to the effect of the passage of time on our discounted cash flow computations (“accretion expense”) for the exit, in prior periods, of certain of our South San Francisco buildings. During the nine months ended September 30, 2015 , the restructuring charge also included the impact of a new sublease executed in June 2015 and additional changes in assumptions regarding anticipated sublease activities. The total outstanding restructuring liability related to the 2010 Restructurings is included in the current and long-term portion of restructuring on the accompanying Consolidated Balance Sheets. The changes to this liability during the nine months ended September 30, 2015 is summarized in the following table (in thousands): Facility Charges Restructuring liability as of December 31, 2014 $ 9,454 Restructuring charge 655 Cash payments (5,439 ) Adjustments or non-cash credits 325 Restructuring liability as of September 30, 2015 $ 4,995 We expect to pay accrued facility charges of $5.0 million , net of cash received from our subtenants, through the end of our lease terms of the buildings, the last of which ends in 2017. We expect to incur additional restructuring charges of approximately $0.4 million relating to the effect of accretion expense through to the end of the building lease terms. |
Cash and Investments
Cash and Investments | 9 Months Ended |
Sep. 30, 2015 | |
Investments, Debt and Equity Securities [Abstract] | |
Cash and Investments | CASH AND INVESTMENTS All of our cash equivalents and investments are classified as available-for-sale. The following tables summarize cash and cash equivalents, investments, and restricted cash and investments by balance sheet line item as of September 30, 2015 and December 31, 2014 (in thousands): September 30, 2015 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Cash and cash equivalents $ 145,642 $ — $ — $ 145,642 Short-term investments 52,142 38 (11 ) 52,169 Long-term investments 81,559 43 (2 ) 81,600 Long-term restricted cash and investments 2,650 — — 2,650 Total cash and investments $ 281,993 $ 81 $ (13 ) $ 282,061 December 31, 2014 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Cash and cash equivalents $ 80,395 $ — $ — $ 80,395 Short-term investments 63,988 37 (135 ) 63,890 Short-term restricted cash and investments 12,105 107 — 12,212 Long-term investments 81,600 1 (22 ) 81,579 Long-term restricted cash and investments 4,684 — — 4,684 Total cash and investments $ 242,772 $ 145 $ (157 ) $ 242,760 Under our loan and security agreement with Silicon Valley Bank, we are required to maintain compensating balances on deposit in one or more investment accounts with Silicon Valley Bank or one of its affiliates. The total collateral balances as of September 30, 2015 and December 31, 2014 were $81.6 million and $82.0 million , respectively, and are reflected in our Consolidated Balance Sheets in short- and long-term investments. See “Note 8 - Debt” to our Consolidated Financial Statements included in our Annual Report on Form 10-K for the year ended December 31, 2014 , for more information regarding the collateral balance requirements under our Silicon Valley Bank loan and security agreement. The following tables summarize our cash equivalents and investments by security type as of September 30, 2015 and December 31, 2014 . The amounts presented exclude cash, but include investments classified as cash equivalents (in thousands): September 30, 2015 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Money market funds $ 34,895 $ — $ — $ 34,895 Commercial paper 140,144 — — 140,144 Corporate bonds 89,778 79 (13 ) 89,844 U.S. government sponsored entities 14,978 1 — 14,979 Total investments $ 279,795 $ 80 $ (13 ) $ 279,862 December 31, 2014 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Money market funds $ 23,376 $ — $ — $ 23,376 Commercial paper 56,714 — — 56,714 Corporate bonds 143,444 35 (157 ) 143,322 U.S. government sponsored entities 12,105 107 — 12,212 Municipal bonds 2,659 3 — 2,662 Total investments $ 238,298 $ 145 $ (157 ) $ 238,286 There were no sales of investments during the nine months ended September 30, 2015 and 2014 . All of our investments are subject to a quarterly impairment review. During the nine months ended September 30, 2015 and 2014 , we did not record any other-than-temporary impairment charges on our available-for-sale securities. As of September 30, 2015 , there were 14 investments in an unrealized loss position with gross unrealized losses of $13 thousand and an aggregate fair value $27.9 million . Investments in an unrealized loss position are all corporate bonds. All of our investments in an unrealized loss position have been so for less than one year and the unrealized losses were not attributed to credit risk, but rather associated with the changes in interest rates. Based on the scheduled maturities of our investments, we concluded that the unrealized losses in our investment securities are not other-than-temporary, as it is more likely than not that we will hold these investments for a period of time sufficient for a recovery of our cost basis. The following table summarizes the fair value of securities classified as available-for-sale by contractual maturity as of September 30, 2015 (in thousands): Mature within One Year After One Year through Two Years Fair Value Money market funds $ 34,895 $ — $ 34,895 Commercial paper 140,144 — 140,144 Corporate bonds 60,658 29,186 89,844 U.S. government sponsored entities 14,979 — 14,979 Total investments $ 250,676 $ 29,186 $ 279,862 Cash is excluded from the table above. The classification of certain compensating balances and restricted investments are dependent upon the term of the underlying restriction on the asset and not the maturity date of the investment. Therefore, certain long-term investments and long-term restricted cash and investments have contractual maturities within one year. |
Inventory
Inventory | 9 Months Ended |
Sep. 30, 2015 | |
Inventory Disclosure [Abstract] | |
Inventory | INVENTORY Inventory consists of the following (in thousands): September 30, December 31, Raw materials $ 1,063 $ 1,118 Work in process 2,203 2,845 Finished goods 745 559 Total 4,011 4,522 Less: non-current portion included in Other assets (1,890 ) (2,141 ) Inventory $ 2,121 $ 2,381 We generally relieve inventory on a first-expiry, first-out basis. Write-downs related to expiring and excess inventory are charged to cost of goods sold. Such write-downs were $1.1 million for the nine months ended September 30, 2015 and were nominal for the nine months ended September 30, 2014 . The non-current portion of inventory is recorded within Other assets on the accompanying Condensed Consolidated Balance Sheets and is comprised of a portion of the active pharmaceutical ingredient that is included in raw materials and work in process inventories. There were no other write-downs for obsolete inventory. |
Debt
Debt | 9 Months Ended |
Sep. 30, 2015 | |
Debt Disclosure [Abstract] | |
Debt | DEBT The amortized carrying amount of our debt consists of the following (in thousands): September 30, December 31, Convertible Senior Subordinated Notes due 2019 $ 196,371 $ 182,395 Secured Convertible Notes due 2018 101,515 98,880 Silicon Valley Bank term loan 80,000 80,000 Silicon Valley Bank line of credit — 381 Total debt 377,886 361,656 Less: current portion (450 ) (99,261 ) Long-term debt $ 377,436 $ 262,395 See “Note 8 - Debt” to our Consolidated Financial Statements included in our Annual Report on Form 10-K for the year ended December 31, 2014 , for additional information on the terms of our debt, including a description of the conversion features of the of 4.25% Convertible Senior Subordinated Notes due 2019 (the “2019 Notes”) and our Secured Convertible Notes due June 2018 (the “Deerfield Notes”). Convertible Senior Subordinated Notes due 2019 In August 2012 , we issued and sold $287.5 million aggregate principal amount of the 2019 Notes. As of September 30, 2015 , the entire principal balance remains outstanding. The following is a summary of the liability component of the 2019 Notes (in thousands): September 30, December 31, Net carrying amount of the liability component $ 196,371 $ 182,395 Unamortized discount of the liability component 91,129 105,105 Face amount of the 2019 Notes $ 287,500 $ 287,500 The debt discount and debt issuance costs will be amortized as interest expense through August 2019. The following is a summary of interest expense for the 2019 Notes (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2015 2014 2015 2014 Stated coupon interest $ 3,054 $ 3,055 $ 9,164 $ 9,198 Amortization of debt discount and debt issuance costs 4,951 4,502 14,505 13,194 Total interest expense $ 8,005 $ 7,557 $ 23,669 $ 22,392 The balance of unamortized fees and costs was $2.7 million and $3.3 million as of September 30, 2015 and December 31, 2014 , respectively, which is included in Other assets on the accompanying Condensed Consolidated Balance Sheets. Secured Convertible Notes due June 2018 In June 2010, we entered into a note purchase agreement with Deerfield Private Design Fund, L.P. and Deerfield Private Design International, L.P., (the “Original Deerfield Purchasers”), pursuant to which, on July 1, 2010, we sold to the Original Deerfield Purchasers an aggregate of $124.0 million principal amount of our Secured Convertible Notes due July 1, 2015, which we refer to as the Original Deerfield Notes, for an aggregate purchase price of $80.0 million , less closing fees and expenses of approximately $2.0 million . On January 22, 2014, the note purchase agreement was amended to provide us with an option to extend the maturity date of our indebtedness under the note purchase agreement to July 1, 2018. On July 1, 2015, we made a $4.0 million principal payment and then extended the maturity date of the Original Deerfield Notes from July 1, 2015 to July 1, 2018. In connection with the extension, Deerfield Partners, L.P. and Deerfield International Master Fund, L.P. (the “New Deerfield Purchasers”) acquired the $100.0 million principal amount of the Original Deerfield Notes and we entered into the Restated Deerfield Notes with each of the New Deerfield Purchasers, representing the $100.0 million principal amount. We refer to the Original Deerfield Purchasers and the New Deerfield Purchasers collectively as “Deerfield”, and to the Original Deerfield Notes and Restated Deerfield Notes, collectively as the “Deerfield Notes”. As of September 30, 2015 and December 31, 2014 , the outstanding principal balance on the Deerfield Notes was $101.9 million and $104.0 million , respectively, which, subject to certain limitations, is payable in cash or in stock at our discretion. Beginning on July 2, 2015, the outstanding principal amount of the Deerfield Notes bears interest at the rate of 7.5% per annum to be paid in cash, quarterly in arrears, and 7.5% per annum to be paid in kind, quarterly in arrears, for a total interest rate of 15% per annum. Through July 1, 2015, the outstanding principal amount of the Deerfield Notes bore interest in the annual amount of $6.0 million , payable quarterly in arrears. The following is a summary of interest expense for the Deerfield Notes (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2015 2014 2015 2014 Stated coupon interest paid in cash $ 1,891 $ 1,512 $ 4,866 $ 4,487 Amortization of debt discount, debt issuance costs and accrual of interest paid in kind 1,959 3,005 7,279 8,631 Total interest expense $ 3,850 $ 4,517 $ 12,145 $ 13,118 The balance of unamortized fees and costs was $0.8 million and $1.4 million as of September 30, 2015 and December 31, 2014 , respectively, which is included in Other assets on the accompanying Condensed Consolidated Balance Sheets. Prior to March 4, 2015, the unamortized discount, fees and costs were amortized into interest expense as a yield adjustment through July 1, 2015. Effective March 4, 2015, upon notification of our election to require the New Deerfield Purchasers to acquire the Deerfield Notes and extend the maturity date to July 1, 2018, we began to amortize the remaining unamortized discount, fees and costs through July 1, 2018 using the effective interest method and an effective interest rate of 15.27% . We were required to make an additional mandatory prepayment on the Deerfield Notes in January 2015 equal to 15% of certain revenues from collaborative arrangements, which we refer to as Development/Commercialization Revenue, received during the prior fiscal year, subject to a maximum prepayment amount of $27.5 million . As a result of the extension of the maturity date of the Deerfield Notes to July 1, 2018, our obligation to make annual mandatory prepayments equal to 15% of Development/Commercialization Revenue received by us during the prior fiscal year will continue to apply in each of 2016, 2017 and 2018. However, we will only be obligated to make any such annual mandatory prepayment if the New Deerfield Purchasers provide notice to us of their election to receive the prepayment. Pursuant to this requirement, we may be required make a mandatory prepayment of $450,000 in January 2016 as a result of to the $3.0 million milestone payment received from Merck during the three months ended September 30, 2015. That portion of the Deerfield Notes is included in current liabilities. Mandatory prepayments relating to Development/Commercialization Revenue will continue to be subject to a maximum annual prepayment amount of $27.5 million . The definition of “Development/Commercialization Revenue” expressly excludes any sale or distribution of drug or pharmaceutical products in the ordinary course of our business, and any proceeds from any Intellectual Property Sale, but would include our share of the net profits from the commercialization of cobimetinib in the U.S. and the receipt of royalties from cobimetinib sales outside the U.S., if any. In connection with the amendment to the note purchase agreement, in January 2014 we issued to the New Deerfield Purchasers two -year warrants (the “2014 Deerfield Warrants”) to purchase an aggregate of 1,000,000 shares of our common stock at an exercise price of $9.70 per share. Subsequent to our March 4, 2015 notification of our election to extend the maturity date of the Deerfield Notes, the exercise price of the 2014 Deerfield Warrants was reset to $3.445 per share and the term was extended by two years to January 22, 2018. See “Note 6 - Common Stock and Warrants” for further information on the 2014 Deerfield Warrants. |
Common Stock and Warrants
Common Stock and Warrants | 9 Months Ended |
Sep. 30, 2015 | |
Warrants and Rights Note Disclosure [Abstract] | |
Common Stock and Warrants | COMMON STOCK AND WARRANTS Sale of Shares of Common Stock On July 29, 2015 we completed a registered underwritten public offering of 28,750,000 shares of our common stock, including 3,750,000 shares issued under the underwriters’ 30 -day option to buy shares, at a price of $5.40 per share pursuant to a shelf registration statement previously filed with the SEC, which was filed and automatically became effective on July 1, 2015. We received approximately $145.6 million in net proceeds from the offering after deducting the underwriting discount and other estimated expenses. We estimate that the expenses of the offering, excluding underwriting discount, will be approximately $0.4 million , and are payable by us. The shares of common stock were listed on The NASDAQ Global Select Market. All of the shares in the offering were sold by the Company. The Underwriting Agreement contains customary representations, warranties and agreements by the Company, indemnification obligations of the Company and the Underwriter, including for liabilities under the Securities Act of 1933, as amended, other obligations of the parties and termination provisions. The representations, warranties and covenants contained in the Underwriting Agreement were made only for purposes of such agreement and as of specific dates, were solely for the benefit of the parties to such agreement and may be subject to limitations agreed upon by the contracting parties. Warrants In connection with an amendment to the note purchase agreement for the Original Deerfield Notes, in January 2014 we issued to the New Deerfield Purchasers two -year warrants to purchase an aggregate of 1,000,000 shares of our common stock at an exercise price of $9.70 per share. Under the terms of the 2014 Deerfield Warrants, the warrants would be extended by two years and the exercise price would be reset to the lower of (i) the existing exercise price and (ii) 120% of the volume weighted average price of our common stock for the ten trading days following our election to extend the maturity date of the Deerfield Notes. Subsequent to our March 2015 notification of our election to extend the maturity date of the Deerfield Notes, the exercise price of the 2014 Deerfield Warrants was reset to $3.445 per share and the term was extended by two years to January 22, 2018. Due to the potential increase in term and decrease of the exercise price, the 2014 Deerfield Warrants were included in Other long-term liabilities at their current estimated fair value, which was $1.5 million and $0.9 million as of March 18, 2015 and December 31, 2014 , respectively. We recorded an unrealized loss of $0.5 million and an unrealized gain of $1.9 million on the 2014 Deerfield Warrants during the nine months ended September 30, 2015 and 2014 , respectively, which is included in Interest income and other, net. Subsequent to our March 4, 2015 notification of our election to extend the maturity date of the Deerfield Notes, the terms of the 2014 Deerfield Warrants became fixed as of March 18, 2015 and the 2014 Deerfield Warrants were transferred to Additional paid-in capital as of that date at their then estimated fair value of $1.5 million . See “Note 7 - Fair Value Measurements” for more information on the valuation of the 2014 Deerfield Warrants. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2015 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | FAIR VALUE MEASUREMENTS The following table sets forth the fair value of our financial assets and liabilities that were measured and recorded on a recurring basis as of September 30, 2015 and December 31, 2014 . We did not have any financial liabilities that were measured and recorded on a recurring basis or Level 3 investments as of September 30, 2015 . The amounts presented exclude cash, but include investments classified as cash equivalents (in thousands): September 30, 2015 Level 1 Level 2 Total Money market funds $ 34,895 $ — $ 34,895 Commercial paper — 140,144 140,144 Corporate bonds — 89,844 89,844 U.S. government sponsored entities — 14,979 14,979 Total financial assets $ 34,895 $ 244,967 $ 279,862 December 31, 2014 Level 1 Level 2 Level 3 Total Financial assets: Money market funds $ 23,376 $ — $ — $ 23,376 Commercial paper — 56,714 — 56,714 Corporate bonds — 143,322 — 143,322 U.S. government sponsored entities — 12,212 — 12,212 Municipal bonds — 2,662 — 2,662 Total financial assets $ 23,376 $ 214,910 $ — $ 238,286 Financial liabilities: Warrants $ — $ — $ 921 $ 921 The following is a reconciliation of changes in the fair value of warrants which are classified as Level 3 in the fair value hierarchy (in thousands) : Balance at December 31, 2014 $ 921 Unrealized loss at final re-measurement of warrants on March 18, 2015, included in Interest income and other, net 549 Transfer of warrants from Other long-term liabilities to Additional paid-in capital at their estimated fair value upon warrant repricing on March 18, 2015 (1,470 ) Balance at September 30, 2015 $ — The estimated fair value of our financial instruments that are carried at amortized cost for which it is practicable to determine a fair value was as follows (in thousands) : September 30, 2015 December 31, 2014 Carrying Amount Fair Value Carrying Amount Fair Value 2019 Notes $ 196,371 $ 355,638 $ 182,395 $ 156,889 Silicon Valley Bank term loan $ 80,000 $ 79,884 $ 80,000 $ 79,943 Silicon Valley Bank line of credit $ — $ — $ 381 $ 381 As of September 30, 2015 , the carrying value and estimated fair value of our Deerfield Notes was $101.5 million and $103.9 million , respectively. As of December 31, 2014 , we had determined that it was not practicable to determine the fair value of the Deerfield Notes due to the unique structure of the instrument, including the Extension Option, which was exercised in March 2015, and was financed by entities affiliated with Deerfield. The carrying amounts of cash, trade and other receivables, accounts payable, accrued clinical trial liabilities, accrued compensation and benefits, and other accrued liabilities approximate their fair values and are excluded from the tables above. The following methods and assumptions were used to estimate the fair value of each class of financial instrument for which it is practicable to estimate a value: • When available, we value investments based on quoted prices for those financial instruments, which is a Level 1 input. Our remaining investments are valued using third-party pricing sources, which use observable market prices, interest rates and yield curves observable at commonly quoted intervals of similar assets as observable inputs for pricing, which is a Level 2 input. • The 2019 Notes are valued using a third-party pricing model that is based in part on average trading prices, which is a Level 2 input. The 2019 Notes are not marked-to-market and are shown at their initial fair value less the unamortized discount; the portion of the value allocated to the conversion option is included in Stockholders’ deficit on the accompanying Condensed Consolidated Balance Sheets. • We estimate the fair value of our other debt instruments, where possible, using the net present value of the payments. For the Silicon Valley Bank term loan and line of credit, we use an interest rate that is consistent with money-market rates that would have been earned on our non-interest-bearing compensating balances as our discount rate, which is a Level 2 input. For the Deerfield Notes, we used a discount rate of 15% , which we estimate as our current borrowing rate for similar debt as of September 30, 2015 , which is a Level 3 input. • The 2014 Deerfield Warrants were valued using a Monte Carlo simulation model until December 31, 2014 and the Black-Scholes Merton option pricing model on March 18, 2015. The expected life is based on the contractual terms of the 2014 Deerfield Warrants, and in certain simulations, assumes the two year extension that would result from our exercise of the Extension Option; as of and subsequent to September 30, 2014, we estimated that it was probable that we would exercise this two -year extension. We consider implied volatility as well as our historical volatility in developing our estimate of expected volatility. The fair value of the 2014 Deerfield Warrants was estimated using the following assumptions, which, except for risk-free interest rate, are Level 3 inputs (dollars in thousands): March 18, 2015 December 31, 2014 Risk-free interest rate 0.87 % 1.07 % Dividend yield — % — % Volatility 95 % 96 % Average expected life 2.8 years 3.1 years |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2015 | |
Share-based Compensation [Abstract] | |
Stock-Based Compensation | STOCK-BASED COMPENSATION We recorded and allocated employee stock-based compensation expense for our equity incentive plans and our 2000 Employee Stock Purchase Plan (“ESPP”) as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2015 2014 2015 2014 Research and development expense $ 6,676 $ 112 $ 8,049 $ 3,148 Selling, general and administrative expense 5,350 624 7,371 5,328 Restructuring-related stock-based compensation (recovery) expense — (22 ) — (22 ) Total employee stock-based compensation expense $ 12,026 $ 714 $ 15,420 $ 8,454 We use the Black-Scholes Merton option pricing model to value our stock options. The expected life computation is based on historical, exercise patterns and post-vesting termination behavior. We considered implied volatility as well as our historical volatility in developing our estimate of expected volatility. The fair value of employee stock option awards and ESPP purchases was estimated using the following assumptions and resulted in the following weighted average fair values: Stock Options Three Months Ended September 30, Nine Months Ended September 30, 2015 2014 2015 2014 Weighted average grant-date fair values $ 3.92 $ 1.19 $ 2.51 $ 1.47 Assumptions: Risk-free interest rate 1.18 % 1.83 % 1.20 % 1.81 % Dividend yield — % — % — % — % Volatility 88 % 86 % 93 % 85 % Expected life 4.6 years 5.5 years 4.5 years 5.5 years Employee Stock Purchase Plan Three Months Ended September 30, Nine Months Ended September 30, 2015 2014 2015 2014 Weighted average grant-date fair values $ 1.26 $ 1.21 $ 0.97 $ 1.35 Assumptions: Risk-free interest rate 0.06 % 0.05 % 0.09 % 0.06 % Dividend yield — % — % — % — % Volatility 107 % 68 % 101 % 66 % Expected life 6 months 6 months 6 months 6 months A summary of all stock option activity for the nine months ended September 30, 2015 is presented below (dollars in thousands , except per share amounts): Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term Aggregate Intrinsic Value Options outstanding at December 31, 2014 27,811,992 $ 5.00 Granted 8,505,300 $ 3.70 Exercised (875,504 ) $ 4.33 Forfeited (924,890 ) $ 3.67 Expired (4,403,827 ) $ 6.52 Options outstanding at September 30, 2015 30,113,071 $ 4.48 4.83 years $ 58,332 Exercisable September 30, 2015 18,385,413 $ 5.06 3.89 years $ 29,649 As of September 30, 2015 , a total of 6,980,194 shares were available for grant under our stock option plans. As of September 30, 2015 , $23.5 million of total unrecognized compensation expense related to employee stock options was expected to be recognized over a weighted-average period of 2.73 years . On July 20, 2015, as a result of positive top-line results from the primary analysis of METEOR, the Compensation Committee of the Board of Directors of Exelixis convened to determine we had met certain performance objectives for performance-based stock options granted to employees in 2013, 2014 and 2015. As a result of this determination, 6,982,613 performance-based stock options vested on July 20, 2015. Previously, we had not considered achievement of those performance objectives to be probable and therefore, we recorded $9.4 million in employee stock-based compensation expense during the three months ended September 30, 2015 related to those options. We have an additional 5,934,063 outstanding unvested stock options as of September 30, 2015 which were granted to employees in 2014 and 2015 and are subject to performance objectives tied to the achievement of clinical and regulatory goals set by the Compensation Committee of our Board of Directors and will vest in full or part based on achievement of such goals. As of September 30, 2015 , we did not consider achievement of those performance objectives to be probable and therefore we have not recorded any stock-based compensation expense for those stock options. The grant date fair value of the outstanding unvested performance-based stock options was $7.4 million . A summary of all restricted stock unit (“RSU”) activity for the nine months ended September 30, 2015 is presented below (dollars in thousands , except per share amounts): Shares Weighted Average Grant Date Fair Value Weighted Average Remaining Contractual Term Aggregate Intrinsic Value Awards outstanding at December 31, 2014 961,469 $ 3.82 Awarded 673,785 $ 4.84 Released (414,694 ) $ 3.62 Forfeited (124,865 ) $ 5.32 Awards outstanding at September 30, 2015 1,095,695 $ 4.35 2.11 years $ 6,476 As of September 30, 2015 , $3.5 million of total unrecognized compensation expense related to employee RSUs was expected to be recognized over a weighted-average period of 2.11 years . |
Net Loss Per Share
Net Loss Per Share | 9 Months Ended |
Sep. 30, 2015 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | NET LOSS PER SHARE The following table sets forth a reconciliation of basic and diluted net loss per share (in thousands, except per share amounts): Three Months Ended September 30, Nine Months Ended September 30, 2015 2014 2015 2014 Numerator: Net loss $ (47,564 ) $ (62,560 ) $ (126,096 ) $ (210,589 ) Denominator: Shares used in computing basic and diluted net loss per share 217,587 195,126 203,153 193,855 Net loss per share, basic and diluted $ (0.22 ) $ (0.32 ) $ (0.62 ) $ (1.09 ) The following table sets forth outstanding potentially dilutive shares of common stock that are not included in the computation of diluted net loss per share because, to do so would be anti-dilutive (in thousands): September 30 2015 2014 Convertible Senior Subordinated Notes due 2019 54,118 54,118 Secured Convertible Notes due 2018 33,890 21,616 Outstanding stock options, unvested RSUs and ESPP contributions 31,331 34,243 2014 Deerfield Warrants 1,000 1,000 Total potentially dilutive shares 120,339 110,977 The 2014 Deerfield Warrants are participating securities and the warrant holders do not have a contractual obligation to share in our losses. |
Concentrations of Credit Risk
Concentrations of Credit Risk | 9 Months Ended |
Sep. 30, 2015 | |
Risks and Uncertainties [Abstract] | |
Concentrations of Credit Risk | CONCENTRATIONS OF CREDIT RISK Financial instruments that potentially subject us to concentrations of credit risk are primarily trade and other receivables and investments. Investments consist of money market funds, taxable commercial paper, corporate bonds with high credit quality, U.S. Treasury and government sponsored enterprises, and municipal bonds. All investments are maintained with financial institutions that management believes are creditworthy. Trade and other receivables are unsecured and are concentrated in the pharmaceutical and biotechnology industries. Accordingly, we may be exposed to credit risk generally associated with pharmaceutical and biotechnology companies. We have incurred no bad debt expense since inception. As of September 30, 2015 , 87% of our trade and other receivables are with the specialty pharmacy that sells COMETRIQ in the United States and 13% are with our European distribution partner. Both of these customers pay promptly and within their respective payment terms. All of our long-lived assets are located in the United States. We have operations primarily in the United States, while some of our collaboration partners have headquarters outside of the United States and some of our clinical trials for cabozantinib are also conducted outside of the United States. During the second quarter of 2013, we initiated a Named Patient Use program through our distribution partner, Swedish Orphan Biovitrum (“Sobi”), to support the distribution and commercialization of COMETRIQ for metastatic MTC primarily in the European Union and potentially other countries. In March 2014, the European Commission approved cabozantinib for the treatment of adult patients with progressive, unresectable locally advanced or metastatic MTC, also under the brand name COMETRIQ. In June 2014, we began selling COMETRIQ to Sobi in preparation for commercial sales in certain countries in the European Union. The following table shows the percentage of revenues earned in the United States and the European Union. Three Months Ended September 30, Nine Months Ended September 30, 2015 2014 2015 2014 Percentage of revenues earned in the United States 96 % 108 % 90 % 100 % Percentage of revenues earned in the European Union 4 % (8 )% 10 % — % Net product revenues in the European Union for the three months and nine months ended September 30, 2014 included a $1.8 million reduction to revenue for a project management fee payable to our European distributor upon its achievement of a cumulative revenue goal. As a result, for the three months ended September 30, 2014 discounts and allowances exceeded gross revenues for the European Union causing the percentage of revenues earned in the United States to exceed 100% during the period. We recorded a $0.1 million gain relating to foreign exchange fluctuations for both the nine months ended September 30, 2015 and 2014 . The following table sets forth the percentage of revenues recognized under our collaboration agreements and product sales to the specialty pharmacies that represent 10% or more of total revenues during one or more of the periods presented: Three Months Ended September 30, Nine Months Ended September 30, 2015 2014 2015 2014 Collaboration agreements: Merck 30 % — % 11 % — % Product sales: Diplomat Specialty Pharmacy 66 % 108 % 79 % 100 % Swedish Orphan Biovitrum 4 % (8 )% 10 % — % |
Organization and Summary of S17
Organization and Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2015 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization | Organization Exelixis, Inc. (“Exelixis,” “we,” “our” or “us”) is a biopharmaceutical company committed to developing small molecule therapies for the treatment of cancer. Our two most advanced assets are cabozantinib, our wholly-owned inhibitor of multiple receptor tyrosine kinases, and cobimetinib (GDC-0973/XL518), a selective inhibitor of MEK, a dual-specificity kinase, which we out-licensed to Genentech, Inc. (a member of the Roche Group), (“Genentech”). Our development and commercialization efforts are focused primarily on cabozantinib. Cabozantinib was approved by the United States Food and Drug Administration (“FDA”) on November 29, 2012, for the treatment of progressive, metastatic medullary thyroid cancer (“MTC”) in the United States under the brand name COMETRIQ ® . COMETRIQ became commercially available in the United States in January 2013. In March 2014, the European Commission granted cabozantinib conditional marketing authorization for the treatment of adult patients with progressive, unresectable locally advanced or metastatic MTC, also under the brand name COMETRIQ. We are evaluating cabozantinib in a broad development program comprising over 40 clinical trials across multiple indications, including ongoing phase 3 pivotal trials focusing on advanced renal cell carcinoma (“RCC”) and advanced hepatocellular carcinoma (“HCC”). In July 2015, we announced that the phase 3 pivotal trial for RCC met its primary endpoint of demonstrating a statistically significant increase in progression free survival (“PFS”) for cabozantinib, as determined by an independent radiology review committee. In August 2015 the FDA granted Breakthrough Therapy Designation for cabozantinib as a potential treatment for patients with advanced RCC. In October 2015, we initiated rolling submission of our U.S. New Drug Application (“NDA”) with the FDA. On November 10, 2015 , our second most advanced oncology asset, cobimetinib, was approved in the U.S. by the FDA under the brand name COTELLIC TM in combination with vemurafenib as a treatment for patients with BRAF V600 mutation-positive advanced melanoma. In Switzerland, cobimetinib in combination with vemurafenib was approved in August 2015 as a treatment for patients with BRAF V600 mutation-positive advanced melanoma. Roche also filed a Marketing Authorization Application for cobimetinib in combination with vemurafenib for the same indication with the European Medicines Agency and anticipates a regulatory decision before the end of 2015 following a positive opinion issued by the European Committee for Medicinal Products for Human Use, announced in late September 2015. Cobimetinib is subject to a collaboration agreement we entered into with Genentech in December 2006. Pursuant to the collaboration agreement’s financial terms, we believe that cobimetinib has the potential to provide us with a second significant source of revenue. |
Basis of Consolidation | Basis of Consolidation The consolidated financial statements include the accounts of Exelixis and those of our wholly-owned subsidiaries. These entities’ functional currency is the U.S. dollar. All intercompany balances and transactions have been eliminated. |
Basis of Presentation | Basis of Presentation The accompanying unaudited consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States for interim financial information and pursuant to Form 10-Q and Article 10 of Regulation S-X of the Securities and Exchange Commission (“SEC”). Accordingly, they do not include all of the information and footnotes required by U.S. generally accepted accounting principles for complete financial statements. In our opinion, all adjustments (consisting only of normal recurring adjustments) considered necessary for a fair presentation of the results of operations and cash flows for the period presented have been included. |
Fiscal Period | Exelixis adopted a 52- or 53-week fiscal year that generally ends on the Friday closest to December 31st. Fiscal year 2015, a 52-week year, will end on January 1, 2016 , and fiscal year 2014, a 53-week year, ended on January 2, 2015 . For convenience, references in this report as of and for the fiscal periods ended October 2, 2015 and September 26, 2014 , and as of and for the fiscal years ended January 1, 2016 and January 2, 2015 , are indicated as being as of and for the periods ended September 30, 2015 , September 30, 2014 , December 31, 2015 , and December 31, 2014 , respectively. |
Segment Information | Segment Information We operate as a single reportable segment. |
Use of Estimates | Use of Estimates The preparation of our consolidated financial statements is in conformity with accounting principles generally accepted in the United States which requires management to make judgments, estimates and assumptions that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosures. On an ongoing basis, management evaluates its estimates including, but not limited to, those related to inventory, revenue recognition, valuation of long-lived assets, certain accrued liabilities including clinical trial accruals and restructuring liability, valuation of warrants, share-based compensation and the valuation of the debt and equity components of our convertible debt at issuance. We base our estimates on historical experience and on various other market-specific and other relevant assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results could differ materially from those estimates. |
Revenue Recognition | Revenue Recognition We recognize revenue from the sale of COMETRIQ and have historically recognized revenue from license fees and milestones earned on research and collaboration arrangements. During the three months ended September 30, 2015 , we recognized $3.0 million in contract revenues from a milestone payment received from Merck related to its worldwide license of our PI3K-delta program. See “Note 1 - Organization and Summary of Significant Accounting Policies” to our Consolidated Financial Statements included in our Annual Report on Form 10-K for the year ended December 31, 2014 for a description of our policies for revenue recognition on research and collaboration agreements. We did not enter into any new collaboration agreements during the nine months ended September 30, 2015 . See “Note 2 - Research and Collaboration Agreements” to our Consolidated Financial Statements included in our Annual Report on Form 10-K for the year ended December 31, 2014 for a description of our existing collaboration agreements. Net Product Revenues We recognize revenue when it is both realized or realizable and earned, meaning persuasive evidence of an arrangement exists, delivery has occurred, title has transferred, the price is fixed or determinable, there are no remaining customer acceptance requirements, and collectability of the resulting receivable is reasonably assured. For product sales in the United States, this generally occurs upon delivery of the product to the specialty pharmacy. For product sales in Europe, this generally occurs when our European distribution partner has accepted the product, at which time they are no longer able to return the product. We sell our product, COMETRIQ, in the United States to a specialty pharmacy that benefits from customer incentives and has a right of return. Prior to 2015, COMETRIQ had limited sales history and we could not reliably estimate expected future returns, discounts and rebates of the product at the time the product was sold to the specialty pharmacy, therefore we recognized revenue when the specialty pharmacy provided the product to a patient based on the fulfillment of a prescription, frequently referred to as the “sell-through” revenue recognition model. Recently we have established sufficient historical experience and data to reasonably estimate expected future returns of the product and the discounts and rebates due to payors at the time of shipment to the specialty pharmacy. Accordingly, beginning in January 2015 we began to recognize revenue upon delivery to our U.S. specialty pharmacy. This approach is frequently referred to as the “sell-in” revenue recognition model. In connection with the change in the timing of recognition of U.S. COMETRIQ sales, we recorded a one-time adjustment to recognize revenue and related costs that had previously been deferred at December 31, 2014, resulting in additional gross product revenues of $2.6 million and a nominal amount of cost of goods sold for the nine months ended September 30, 2015 ; there were no such adjustments recorded for the three months ended September 30, 2015 or during the comparable periods in 2014. We also utilize the “sell-in” revenue recognition model for sales to our European distribution partner for all periods presented. Once the European distributer has accepted the product, the product is no longer subject to return; therefore, we record revenue at the time our European distribution partner has accepted the product. Product Sales Discounts and Allowances We calculate gross product revenues based on the price that we charge our United States specialty pharmacy and our European distribution partner. We estimate our domestic net product revenues by deducting from our gross product revenues (a) trade allowances, such as discounts for prompt payment, (b) estimated government rebates and chargebacks, and (c) estimated costs of patient assistance programs. Discounts and allowances for foreign sales for the nine months ended September 30, 2015 and three and nine months ended September 30, 2014 included portions of a one-time $2.4 million project management fee payable to our European distribution partner upon its achievement of a cumulative revenue goal. During the three months ended September 30, 2014, we determined that the achievement of the revenue goal was probable and therefore we recorded $1.8 million of the project management fee. $1.0 million of the $1.8 million we recorded during the three months ended September 30, 2014 represented amounts that would have been previously recorded had the cumulative revenue goal been determined to be probable in those periods. During the nine months ended September 30, 2015 we recorded an additional $0.1 million of the project management fee; no such fees were recognized within product sales during the three months ended September 30, 2015 . We also deduct from gross product revenues an estimated credit for product originally delivered with expiry of 18 months or less that is potentially payable to our European distribution partner; such deductions were nominal during the three and nine months ended September 30, 2015 and 2014. We initially record estimates for these deductions at the time we recognize the gross revenue. We update our estimates on a recurring basis as new information becomes available. See “Note 1 - Organization and Summary of Significant Accounting Policies” to our Consolidated Financial Statements included in our Annual Report on Form 10-K for the year ended December 31, 2014 for a further description of our discounts and allowances. |
Cost of Goods Sold | Cost of Goods Sold Cost of goods sold is related to our product revenues and consists primarily of a 3% royalty on net sales of any product incorporating cabozantinib payable to GlaxoSmithKline, and to a lesser extent, indirect labor costs, the cost of manufacturing, write-downs related to expiring and excess inventory, and other third party logistics costs of our product. A portion of the manufacturing costs for product sales were incurred prior to regulatory approval of COMETRIQ for the treatment of progressive, metastatic MTC and, therefore, were expensed as research and development costs when those costs were incurred, rather than capitalized as inventory. See “Note 2 - Research and Collaboration Agreements” to our Consolidated Financial Statements included in our Annual Report on Form 10-K for the year ended December 31, 2014 for additional information related to the 3% royalty payable to GlaxoSmithKline. |
Recently Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2014-09, Revenue from Contracts with Customers (“ASU 2014-09”). ASU 2014-09 supersedes the revenue recognition requirements of FASB Accounting Standards Codification (“ASC”) Topic 605, Revenue Recognition and most industry-specific guidance throughout the Accounting Standards Codification, resulting in the creation of FASB ASC Topic 606, Revenue from Contracts with Customers . ASU 2014-09 requires entities to recognize revenue in a way that depicts the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled to in exchange for those goods or services. On July 9, 2015, the FASB deferred the effective date by one year for public entities for annual and interim reporting periods beginning after December 15, 2017. Early adoption is permitted for periods after December 15, 2016. We are currently evaluating the impact of adopting ASU 2014-09, inclusive of available transitional methods on our consolidated financial statements and related disclosures. In August 2014, the FASB issued ASU No. 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern (“ ASU 2014-15”) . ASU 2014-15 explicitly requires management to evaluate, at each annual or interim reporting period, whether there are conditions or events that exist that raise substantial doubt about an entity’s ability to continue as a going concern within one year after the date the financial statements are issued and to provide related disclosures. ASU 2014-15 is effective for annual periods ending after December 15, 2016 and earlier application is permitted. The adoption of this guidance will not have any impact on the Company’s financial position and results of operations and, at this time, we do not expect any impact on its disclosures. In April 2015, the FASB issued Accounting Standards Update No. 2015-03, Simplifying the Presentation of Debt Issuance Costs which Changes the Presentation of Debt Issuance Costs in Financial Statements (“ASU 2015-03”), which requires an entity to present such costs in the balance sheet as a direct deduction from the related debt liability rather than as an asset. Amortization of the costs will continue to be reported as interest expense. ASU 2015-03 will be effective for annual reporting periods beginning after December 15, 2015 and interim periods within fiscal years beginning after December 15, 2016, with early adoption permitted. The new guidance will be applied retrospectively to each prior period presented. If we had adopted ASU 2015-03, as of September 30, 2015 , it would have resulted in a reduction of Other assets and total debt by $3.5 million and $4.7 million as September 30, 2015 and December 31, 2014, respectively. |
Restructurings (Tables)
Restructurings (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
2014 Restructuring [Member] | |
Restructuring Cost and Reserve [Line Items] | |
Summary Of Components Of Restructuring Liability | The components of and changes to these liabilities during the nine months ended September 30, 2015 are summarized in the following table (in thousands): Employee Severance and Other Benefits Facility Asset Sales Legal and Other Fees Total Restructuring liability as of December 31, 2014 $ 1,290 $ — $ — $ 47 $ 1,337 Restructuring charge (recovery) (150 ) 1,542 (905 ) — 487 Cash (payments) receipts, net (1,021 ) (1,020 ) 1,284 — (757 ) Other non-cash items — 278 (379 ) 3 (98 ) Restructuring liability as of September 30, 2015 $ 119 $ 800 $ — $ 50 $ 969 |
2010 Restructurings [Member] | |
Restructuring Cost and Reserve [Line Items] | |
Summary Of Components Of Restructuring Liability | The changes to this liability during the nine months ended September 30, 2015 is summarized in the following table (in thousands): Facility Charges Restructuring liability as of December 31, 2014 $ 9,454 Restructuring charge 655 Cash payments (5,439 ) Adjustments or non-cash credits 325 Restructuring liability as of September 30, 2015 $ 4,995 |
Cash and Investments (Tables)
Cash and Investments (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of Available-for-Sale Securities | The following tables summarize cash and cash equivalents, investments, and restricted cash and investments by balance sheet line item as of September 30, 2015 and December 31, 2014 (in thousands): September 30, 2015 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Cash and cash equivalents $ 145,642 $ — $ — $ 145,642 Short-term investments 52,142 38 (11 ) 52,169 Long-term investments 81,559 43 (2 ) 81,600 Long-term restricted cash and investments 2,650 — — 2,650 Total cash and investments $ 281,993 $ 81 $ (13 ) $ 282,061 December 31, 2014 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Cash and cash equivalents $ 80,395 $ — $ — $ 80,395 Short-term investments 63,988 37 (135 ) 63,890 Short-term restricted cash and investments 12,105 107 — 12,212 Long-term investments 81,600 1 (22 ) 81,579 Long-term restricted cash and investments 4,684 — — 4,684 Total cash and investments $ 242,772 $ 145 $ (157 ) $ 242,760 |
Summary of Cash and Investments by Security Type | The amounts presented exclude cash, but include investments classified as cash equivalents (in thousands): September 30, 2015 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Money market funds $ 34,895 $ — $ — $ 34,895 Commercial paper 140,144 — — 140,144 Corporate bonds 89,778 79 (13 ) 89,844 U.S. government sponsored entities 14,978 1 — 14,979 Total investments $ 279,795 $ 80 $ (13 ) $ 279,862 December 31, 2014 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Money market funds $ 23,376 $ — $ — $ 23,376 Commercial paper 56,714 — — 56,714 Corporate bonds 143,444 35 (157 ) 143,322 U.S. government sponsored entities 12,105 107 — 12,212 Municipal bonds 2,659 3 — 2,662 Total investments $ 238,298 $ 145 $ (157 ) $ 238,286 |
Summary of Available-for-Sale Securities by Contractual Maturity | The following table summarizes the fair value of securities classified as available-for-sale by contractual maturity as of September 30, 2015 (in thousands): Mature within One Year After One Year through Two Years Fair Value Money market funds $ 34,895 $ — $ 34,895 Commercial paper 140,144 — 140,144 Corporate bonds 60,658 29,186 89,844 U.S. government sponsored entities 14,979 — 14,979 Total investments $ 250,676 $ 29,186 $ 279,862 |
Inventory (Tables)
Inventory (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory | Inventory consists of the following (in thousands): September 30, December 31, Raw materials $ 1,063 $ 1,118 Work in process 2,203 2,845 Finished goods 745 559 Total 4,011 4,522 Less: non-current portion included in Other assets (1,890 ) (2,141 ) Inventory $ 2,121 $ 2,381 |
Debt (Tables)
Debt (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Debt Disclosure [Abstract] | |
Schedule Of Debt | The amortized carrying amount of our debt consists of the following (in thousands): September 30, December 31, Convertible Senior Subordinated Notes due 2019 $ 196,371 $ 182,395 Secured Convertible Notes due 2018 101,515 98,880 Silicon Valley Bank term loan 80,000 80,000 Silicon Valley Bank line of credit — 381 Total debt 377,886 361,656 Less: current portion (450 ) (99,261 ) Long-term debt $ 377,436 $ 262,395 |
Summary Of The Liability Component Notes | The following is a summary of the liability component of the 2019 Notes (in thousands): September 30, December 31, Net carrying amount of the liability component $ 196,371 $ 182,395 Unamortized discount of the liability component 91,129 105,105 Face amount of the 2019 Notes $ 287,500 $ 287,500 The debt discount and debt issuance costs will be amortized as interest expense through August 2019. The following is a summary of interest expense for the 2019 Notes (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2015 2014 2015 2014 Stated coupon interest $ 3,054 $ 3,055 $ 9,164 $ 9,198 Amortization of debt discount and debt issuance costs 4,951 4,502 14,505 13,194 Total interest expense $ 8,005 $ 7,557 $ 23,669 $ 22,392 The following is a summary of interest expense for the Deerfield Notes (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2015 2014 2015 2014 Stated coupon interest paid in cash $ 1,891 $ 1,512 $ 4,866 $ 4,487 Amortization of debt discount, debt issuance costs and accrual of interest paid in kind 1,959 3,005 7,279 8,631 Total interest expense $ 3,850 $ 4,517 $ 12,145 $ 13,118 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Fair Value Disclosures [Abstract] | |
Schedule Of Fair Value Of Financial Assets Measured On A Recurring Basis | The amounts presented exclude cash, but include investments classified as cash equivalents (in thousands): September 30, 2015 Level 1 Level 2 Total Money market funds $ 34,895 $ — $ 34,895 Commercial paper — 140,144 140,144 Corporate bonds — 89,844 89,844 U.S. government sponsored entities — 14,979 14,979 Total financial assets $ 34,895 $ 244,967 $ 279,862 December 31, 2014 Level 1 Level 2 Level 3 Total Financial assets: Money market funds $ 23,376 $ — $ — $ 23,376 Commercial paper — 56,714 — 56,714 Corporate bonds — 143,322 — 143,322 U.S. government sponsored entities — 12,212 — 12,212 Municipal bonds — 2,662 — 2,662 Total financial assets $ 23,376 $ 214,910 $ — $ 238,286 Financial liabilities: Warrants $ — $ — $ 921 $ 921 |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation | The following is a reconciliation of changes in the fair value of warrants which are classified as Level 3 in the fair value hierarchy (in thousands) : Balance at December 31, 2014 $ 921 Unrealized loss at final re-measurement of warrants on March 18, 2015, included in Interest income and other, net 549 Transfer of warrants from Other long-term liabilities to Additional paid-in capital at their estimated fair value upon warrant repricing on March 18, 2015 (1,470 ) Balance at September 30, 2015 $ — |
Schedule Of Estimated Fair Value Of Outstanding Debt | The estimated fair value of our financial instruments that are carried at amortized cost for which it is practicable to determine a fair value was as follows (in thousands) : September 30, 2015 December 31, 2014 Carrying Amount Fair Value Carrying Amount Fair Value 2019 Notes $ 196,371 $ 355,638 $ 182,395 $ 156,889 Silicon Valley Bank term loan $ 80,000 $ 79,884 $ 80,000 $ 79,943 Silicon Valley Bank line of credit $ — $ — $ 381 $ 381 |
Schedule of Assumptions Used | The fair value of the 2014 Deerfield Warrants was estimated using the following assumptions, which, except for risk-free interest rate, are Level 3 inputs (dollars in thousands): March 18, 2015 December 31, 2014 Risk-free interest rate 0.87 % 1.07 % Dividend yield — % — % Volatility 95 % 96 % Average expected life 2.8 years 3.1 years |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Share-based Compensation [Abstract] | |
Schedule Of Allocated Employee Stock-Based Compensation Expenses | We recorded and allocated employee stock-based compensation expense for our equity incentive plans and our 2000 Employee Stock Purchase Plan (“ESPP”) as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2015 2014 2015 2014 Research and development expense $ 6,676 $ 112 $ 8,049 $ 3,148 Selling, general and administrative expense 5,350 624 7,371 5,328 Restructuring-related stock-based compensation (recovery) expense — (22 ) — (22 ) Total employee stock-based compensation expense $ 12,026 $ 714 $ 15,420 $ 8,454 |
Schedule Of Fair Value Of Employee Share-Based Payments Awards Estimated Using The Assumptions And Weighted Average Fair Values | The fair value of employee stock option awards and ESPP purchases was estimated using the following assumptions and resulted in the following weighted average fair values: Stock Options Three Months Ended September 30, Nine Months Ended September 30, 2015 2014 2015 2014 Weighted average grant-date fair values $ 3.92 $ 1.19 $ 2.51 $ 1.47 Assumptions: Risk-free interest rate 1.18 % 1.83 % 1.20 % 1.81 % Dividend yield — % — % — % — % Volatility 88 % 86 % 93 % 85 % Expected life 4.6 years 5.5 years 4.5 years 5.5 years Employee Stock Purchase Plan Three Months Ended September 30, Nine Months Ended September 30, 2015 2014 2015 2014 Weighted average grant-date fair values $ 1.26 $ 1.21 $ 0.97 $ 1.35 Assumptions: Risk-free interest rate 0.06 % 0.05 % 0.09 % 0.06 % Dividend yield — % — % — % — % Volatility 107 % 68 % 101 % 66 % Expected life 6 months 6 months 6 months 6 months |
Summary Of All Stock Option Activity | A summary of all stock option activity for the nine months ended September 30, 2015 is presented below (dollars in thousands , except per share amounts): Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term Aggregate Intrinsic Value Options outstanding at December 31, 2014 27,811,992 $ 5.00 Granted 8,505,300 $ 3.70 Exercised (875,504 ) $ 4.33 Forfeited (924,890 ) $ 3.67 Expired (4,403,827 ) $ 6.52 Options outstanding at September 30, 2015 30,113,071 $ 4.48 4.83 years $ 58,332 Exercisable September 30, 2015 18,385,413 $ 5.06 3.89 years $ 29,649 |
Summary Of All RSU Activity | A summary of all restricted stock unit (“RSU”) activity for the nine months ended September 30, 2015 is presented below (dollars in thousands , except per share amounts): Shares Weighted Average Grant Date Fair Value Weighted Average Remaining Contractual Term Aggregate Intrinsic Value Awards outstanding at December 31, 2014 961,469 $ 3.82 Awarded 673,785 $ 4.84 Released (414,694 ) $ 3.62 Forfeited (124,865 ) $ 5.32 Awards outstanding at September 30, 2015 1,095,695 $ 4.35 2.11 years $ 6,476 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Earnings Per Share [Abstract] | |
Schedule Of Reconciliation Of Basic And Diluted Net Income (Loss) Per Share | The following table sets forth a reconciliation of basic and diluted net loss per share (in thousands, except per share amounts): Three Months Ended September 30, Nine Months Ended September 30, 2015 2014 2015 2014 Numerator: Net loss $ (47,564 ) $ (62,560 ) $ (126,096 ) $ (210,589 ) Denominator: Shares used in computing basic and diluted net loss per share 217,587 195,126 203,153 193,855 Net loss per share, basic and diluted $ (0.22 ) $ (0.32 ) $ (0.62 ) $ (1.09 ) |
Schedule Of Potential Shares Of Common Stock Not Included In Computation Of Diluted Net Loss Per Share | The following table sets forth outstanding potentially dilutive shares of common stock that are not included in the computation of diluted net loss per share because, to do so would be anti-dilutive (in thousands): September 30 2015 2014 Convertible Senior Subordinated Notes due 2019 54,118 54,118 Secured Convertible Notes due 2018 33,890 21,616 Outstanding stock options, unvested RSUs and ESPP contributions 31,331 34,243 2014 Deerfield Warrants 1,000 1,000 Total potentially dilutive shares 120,339 110,977 |
Concentrations of Credit Risk (
Concentrations of Credit Risk (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Risks and Uncertainties [Abstract] | |
Schedules of concentration risk | The following table shows the percentage of revenues earned in the United States and the European Union. Three Months Ended September 30, Nine Months Ended September 30, 2015 2014 2015 2014 Percentage of revenues earned in the United States 96 % 108 % 90 % 100 % Percentage of revenues earned in the European Union 4 % (8 )% 10 % — % The following table sets forth the percentage of revenues recognized under our collaboration agreements and product sales to the specialty pharmacies that represent 10% or more of total revenues during one or more of the periods presented: Three Months Ended September 30, Nine Months Ended September 30, 2015 2014 2015 2014 Collaboration agreements: Merck 30 % — % 11 % — % Product sales: Diplomat Specialty Pharmacy 66 % 108 % 79 % 100 % Swedish Orphan Biovitrum 4 % (8 )% 10 % — % |
Organization and Summary of S26
Organization and Summary of Significant Accounting Policies (Details) | 3 Months Ended | 9 Months Ended | 12 Months Ended | 21 Months Ended | 33 Months Ended | |||
Sep. 30, 2015USD ($)trial | Sep. 30, 2014USD ($) | Sep. 30, 2015USD ($)segmenttrial | Sep. 30, 2014USD ($) | Dec. 31, 2014USD ($) | Sep. 30, 2015USD ($)trial | Sep. 30, 2015USD ($)trial | ||
Operations [Line Items] | ||||||||
Number of trials in process | trial | 40 | 40 | 40 | 40 | ||||
Operating cycle | 364 days | 371 days | ||||||
Number of operating segments | segment | 1 | |||||||
Net Income (Loss) Attributable to Parent | $ (47,564,000) | $ (62,560,000) | $ (126,096,000) | $ (210,589,000) | ||||
Retained Earnings (Accumulated Deficit) | (1,893,400,000) | (1,893,400,000) | $ (1,767,304,000) | [1] | $ (1,893,400,000) | $ (1,893,400,000) | ||
Sales Revenue, Goods, Net | 6,854,000 | 6,291,000 | 24,234,000 | 17,758,000 | 64,400,000 | |||
Cash, Cash Equivalents, and Available-for-sale Securities | 282,061,000 | 282,061,000 | 242,760,000 | 282,061,000 | 282,061,000 | |||
Cash, Cash Equivalents, and Short-term Investments | 197,800,000 | 197,800,000 | 197,800,000 | 197,800,000 | ||||
Long-term Investments | 81,600,000 | 81,600,000 | 81,579,000 | [1] | 81,600,000 | 81,600,000 | ||
Restricted Cash and Investments, Noncurrent | 2,650,000 | 2,650,000 | 4,684,000 | [1] | 2,650,000 | 2,650,000 | ||
Product sales discounts and allowances | 1,800,000 | |||||||
Reduction to Other assets | (6,508,000) | (6,508,000) | (8,340,000) | [1] | (6,508,000) | (6,508,000) | ||
Reduction to Total debt | (377,886,000) | (377,886,000) | (361,656,000) | (377,886,000) | (377,886,000) | |||
Adjustments for New Accounting Principle, Early Adoption [Member] | ||||||||
Operations [Line Items] | ||||||||
Reduction to Other assets | 3,500,000 | 3,500,000 | 4,700,000 | 3,500,000 | 3,500,000 | |||
Reduction to Total debt | 3,500,000 | 3,500,000 | $ 4,700,000 | 3,500,000 | $ 3,500,000 | |||
Sobi [Member] | ||||||||
Operations [Line Items] | ||||||||
Product sales discounts and allowances | 0 | 1,800,000 | $ 100,000 | $ 2,400,000 | ||||
Product sales discounts and allowances, determined to be probable | 1,000,000 | |||||||
Glaxo Smith Kline [Member] | ||||||||
Operations [Line Items] | ||||||||
Percent of royalty on net sale | 3.00% | |||||||
“Sell-In” Revenue Recognition Model [Member] | ||||||||
Operations [Line Items] | ||||||||
Sales Revenue, Goods, Net | $ 0 | $ 2,600,000 | $ 0 | |||||
Minimum [Member] | ||||||||
Operations [Line Items] | ||||||||
Operating cycle | 364 days | |||||||
Maximum [Member] | ||||||||
Operations [Line Items] | ||||||||
Operating cycle | 371 days | |||||||
Secured Convertible Notes Due June 2015 [Member] | Deerfield Financing [Member] | ||||||||
Operations [Line Items] | ||||||||
Development milestone payments received under collaborative arrangement | $ 3,000,000 | $ 3,000,000 | ||||||
[1] | The condensed consolidated balance sheet as of December 31, 2014 has been derived from the audited financial statements as of that date. |
Restructurings (Narrative) (Det
Restructurings (Narrative) (Details) $ in Thousands | 3 Months Ended | 9 Months Ended | 39 Months Ended | |||
Sep. 30, 2015USD ($)employee | Sep. 30, 2014USD ($) | Sep. 30, 2015USD ($)employee | Sep. 30, 2014USD ($) | May. 31, 2013restructuring | Dec. 31, 2014USD ($) | |
Restructuring Cost and Reserve [Line Items] | ||||||
Restructuring charge (recovery) | $ 282 | $ 3,758 | $ 1,142 | $ 4,135 | ||
2014 Restructuring [Member] | ||||||
Restructuring Cost and Reserve [Line Items] | ||||||
Aggregate reduction in headcount | employee | 143 | 143 | ||||
Restructuring charge (recovery) | $ 487 | 3,300 | ||||
Restructuring reserve | $ 969 | 969 | $ 1,337 | |||
Property and equipment write-downs | 700 | |||||
2014 Restructuring [Member] | Facility Closing [Member] | ||||||
Restructuring Cost and Reserve [Line Items] | ||||||
Restructuring charge (recovery) | 1,542 | |||||
Restructuring reserve | 800 | 800 | 0 | |||
2014 Restructuring [Member] | Asset Sales [Member] | ||||||
Restructuring Cost and Reserve [Line Items] | ||||||
Restructuring charge (recovery) | (905) | |||||
Restructuring reserve | $ 0 | $ 0 | 0 | |||
2010 Restructurings [Member] | ||||||
Restructuring Cost and Reserve [Line Items] | ||||||
Aggregate reduction in headcount | employee | 429 | 429 | ||||
Restructuring charge (recovery) | $ 700 | $ 800 | ||||
Number of restructurings implemented | restructuring | 5 | |||||
Expected restructuring charges | $ 400 | 400 | ||||
2010 Restructurings [Member] | Facility Closing [Member] | ||||||
Restructuring Cost and Reserve [Line Items] | ||||||
Restructuring charge (recovery) | 655 | |||||
Restructuring reserve | $ 4,995 | $ 4,995 | $ 9,454 |
Restructurings (Summary of Comp
Restructurings (Summary of Components of Restructuring Liability) (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Restructuring Reserve [Roll Forward] | ||||
Restructuring charge (recovery) | $ 282 | $ 3,758 | $ 1,142 | $ 4,135 |
2014 Restructuring [Member] | ||||
Restructuring Reserve [Roll Forward] | ||||
Restructuring liability | 1,337 | |||
Restructuring charge (recovery) | 487 | 3,300 | ||
Cash (payments) receipts, net | (757) | |||
Other non-cash items | (98) | |||
Restructuring liability | 969 | 969 | ||
2014 Restructuring [Member] | Employee Severance and Other Benefits [Member] | ||||
Restructuring Reserve [Roll Forward] | ||||
Restructuring liability | 1,290 | |||
Restructuring charge (recovery) | (150) | 2,600 | ||
Cash (payments) receipts, net | (1,021) | |||
Other non-cash items | 0 | |||
Restructuring liability | 119 | 119 | ||
2014 Restructuring [Member] | Facility Charges [Member] | ||||
Restructuring Reserve [Roll Forward] | ||||
Restructuring liability | 0 | |||
Restructuring charge (recovery) | 1,542 | |||
Cash (payments) receipts, net | (1,020) | |||
Other non-cash items | 278 | |||
Restructuring liability | 800 | 800 | ||
2014 Restructuring [Member] | Asset Sales [Member] | ||||
Restructuring Reserve [Roll Forward] | ||||
Restructuring liability | 0 | |||
Restructuring charge (recovery) | (905) | |||
Cash (payments) receipts, net | 1,284 | |||
Other non-cash items | (379) | |||
Restructuring liability | 0 | 0 | ||
2014 Restructuring [Member] | Legal and Other Fees [Member] | ||||
Restructuring Reserve [Roll Forward] | ||||
Restructuring liability | 47 | |||
Restructuring charge (recovery) | 0 | |||
Cash (payments) receipts, net | 0 | |||
Other non-cash items | 3 | |||
Restructuring liability | 50 | 50 | ||
2010 Restructurings [Member] | ||||
Restructuring Reserve [Roll Forward] | ||||
Restructuring charge (recovery) | 700 | $ 800 | ||
2010 Restructurings [Member] | Facility Charges [Member] | ||||
Restructuring Reserve [Roll Forward] | ||||
Restructuring liability | 9,454 | |||
Restructuring charge (recovery) | 655 | |||
Cash (payments) receipts, net | (5,439) | |||
Other non-cash items | 325 | |||
Restructuring liability | $ 4,995 | $ 4,995 |
Cash and Investments (Details)
Cash and Investments (Details) | 9 Months Ended | ||
Sep. 30, 2015USD ($)accountinvestmentaffiliate | Sep. 30, 2014USD ($) | Dec. 31, 2014USD ($) | |
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | $ 281,993,000 | $ 242,772,000 | |
Gross Unrealized Gains | 81,000 | 145,000 | |
Gross Unrealized Losses | (13,000) | (157,000) | |
Fair Value | $ 282,061,000 | 242,760,000 | |
Debt collateral, number of required investment accounts | account | 1 | ||
Debt collateral, number of affiliate banks | affiliate | 1 | ||
Amortized Cost | $ 279,795,000 | 238,298,000 | |
Gross Unrealized Gains | 80,000 | 145,000 | |
Gross Unrealized Losses | (13,000) | (157,000) | |
Fair Value | 279,862,000 | 238,286,000 | |
Gain (loss) on sale of investments | $ 0 | $ 0 | |
Number of investments in an unrealized loss position, less than 1 year | investment | 14 | ||
Unrealized loss position, less than 1 year | $ 13,000 | ||
Unrealized loss position, less than 1 year, fair value | 27,900,000 | ||
Mature within One Year | 250,676,000 | ||
After One Year through Two Years | 29,186,000 | ||
Fair Value | 279,862,000 | 238,286,000 | |
Money market funds [Member] | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 34,895,000 | 23,376,000 | |
Gross Unrealized Gains | 0 | 0 | |
Gross Unrealized Losses | 0 | 0 | |
Fair Value | 34,895,000 | 23,376,000 | |
Mature within One Year | 34,895,000 | ||
After One Year through Two Years | 0 | ||
Fair Value | 34,895,000 | 23,376,000 | |
Commercial paper [Member] | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 140,144,000 | 56,714,000 | |
Gross Unrealized Gains | 0 | 0 | |
Gross Unrealized Losses | 0 | 0 | |
Fair Value | 140,144,000 | 56,714,000 | |
Mature within One Year | 140,144,000 | ||
After One Year through Two Years | 0 | ||
Fair Value | 140,144,000 | 56,714,000 | |
Corporate bonds [Member] | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 89,778,000 | 143,444,000 | |
Gross Unrealized Gains | 79,000 | 35,000 | |
Gross Unrealized Losses | (13,000) | (157,000) | |
Fair Value | 89,844,000 | 143,322,000 | |
Mature within One Year | 60,658,000 | ||
After One Year through Two Years | 29,186,000 | ||
Fair Value | 89,844,000 | 143,322,000 | |
U.S. Treasury and government sponsored enterprises [Member] | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 14,978,000 | 12,105,000 | |
Gross Unrealized Gains | 1,000 | 107,000 | |
Gross Unrealized Losses | 0 | 0 | |
Fair Value | 14,979,000 | 12,212,000 | |
Mature within One Year | 14,979,000 | ||
After One Year through Two Years | 0 | ||
Fair Value | 14,979,000 | 12,212,000 | |
Municipal bonds [Member] | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 2,659,000 | ||
Gross Unrealized Gains | 3,000 | ||
Gross Unrealized Losses | 0 | ||
Fair Value | 2,662,000 | ||
Fair Value | 2,662,000 | ||
Silicon Valley Bank Loan And Security Agreement [Member] | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Collateral balance | 81,600,000 | 82,000,000 | |
Cash and cash equivalents [Member] | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 145,642,000 | 80,395,000 | |
Gross Unrealized Gains | 0 | 0 | |
Gross Unrealized Losses | 0 | 0 | |
Fair Value | 145,642,000 | 80,395,000 | |
Short-term investments [Member] | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 52,142,000 | 63,988,000 | |
Gross Unrealized Gains | 38,000 | 37,000 | |
Gross Unrealized Losses | (11,000) | (135,000) | |
Fair Value | 52,169,000 | 63,890,000 | |
Short-term restricted cash and investments [Member] | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 12,105,000 | ||
Gross Unrealized Gains | 107,000 | ||
Gross Unrealized Losses | 0 | ||
Fair Value | 12,212,000 | ||
Long-term investments [Member] | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 81,559,000 | 81,600,000 | |
Gross Unrealized Gains | 43,000 | 1,000 | |
Gross Unrealized Losses | (2,000) | (22,000) | |
Fair Value | 81,600,000 | 81,579,000 | |
Long-term restricted cash and investments [Member] | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 2,650,000 | 4,684,000 | |
Gross Unrealized Gains | 0 | 0 | |
Gross Unrealized Losses | 0 | 0 | |
Fair Value | $ 2,650,000 | $ 4,684,000 |
Inventory (Details)
Inventory (Details) - USD ($) $ in Thousands | 9 Months Ended | ||
Sep. 30, 2015 | Dec. 31, 2014 | ||
Inventory Disclosure [Abstract] | |||
Raw materials | $ 1,063 | $ 1,118 | |
Work in process | 2,203 | 2,845 | |
Finished goods | 745 | 559 | |
Total | 4,011 | 4,522 | |
Less: non-current portion included in Other assets | (1,890) | (2,141) | |
Inventory | 2,121 | $ 2,381 | [1] |
Inventory write-down | $ 1,100 | ||
[1] | The condensed consolidated balance sheet as of December 31, 2014 has been derived from the audited financial statements as of that date. |
Debt (Schedule Of Debt) (Detail
Debt (Schedule Of Debt) (Details) - USD ($) $ in Thousands | Sep. 30, 2015 | Dec. 31, 2014 |
Debt Instrument [Line Items] | ||
Total debt | $ 377,886 | $ 361,656 |
Less: current portion | (450) | (99,261) |
Long-term debt | 377,436 | 262,395 |
Senior Subordinated Notes [Member] | 4.25% Convertible Senior Subordinated Notes due August 15, 2019 [Member] | ||
Debt Instrument [Line Items] | ||
Convertible Debt | 196,371 | 182,395 |
Secured Debt [Member] | Secured Convertible Notes due 2018 [Member] | ||
Debt Instrument [Line Items] | ||
Convertible Debt | 101,515 | 98,880 |
Term Loan [Member] | Silicon Valley Bank term loan and Line of Credit [Member] | ||
Debt Instrument [Line Items] | ||
Silicon Valley Bank term loan | 80,000 | 80,000 |
Line of Credit [Member] | Silicon Valley Bank term loan and Line of Credit [Member] | ||
Debt Instrument [Line Items] | ||
Silicon Valley Bank line of credit | $ 0 | $ 381 |
Debt (Convertible Notes) (Detai
Debt (Convertible Notes) (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |||||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | Dec. 31, 2014 | Aug. 31, 2012 | Jun. 30, 2010 | |
Senior Subordinated Notes [Member] | 4.25% Convertible Senior Subordinated Notes due August 15, 2019 [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Net carrying amount of the liability component | $ 196,371,000 | $ 196,371,000 | $ 182,395,000 | ||||
Unamortized discount of the liability component | 91,129,000 | 91,129,000 | 105,105,000 | ||||
Face amount of the 2019 Notes | 287,500,000 | 287,500,000 | 287,500,000 | $ 287,500,000 | |||
Stated coupon interest | 3,054,000 | $ 3,055,000 | 9,164,000 | $ 9,198,000 | |||
Amortization of debt discount and debt issuance costs | 4,951,000 | 4,502,000 | 14,505,000 | 13,194,000 | |||
Total interest expense | 8,005,000 | 7,557,000 | 23,669,000 | 22,392,000 | |||
Secured Convertible Notes Due June 2015 [Member] | Deerfield Financing [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Net carrying amount of the liability component | 101,900,000 | 101,900,000 | $ 104,000,000 | ||||
Face amount of the 2019 Notes | $ 124,000,000 | ||||||
Stated coupon interest | 1,891,000 | 1,512,000 | 4,866,000 | 4,487,000 | |||
Amortization of debt discount and debt issuance costs | 1,959,000 | 3,005,000 | 7,279,000 | 8,631,000 | |||
Total interest expense | $ 3,850,000 | $ 4,517,000 | $ 12,145,000 | $ 13,118,000 |
Debt (Narrative) (Details)
Debt (Narrative) (Details) - USD ($) | Jul. 01, 2015 | Mar. 18, 2015 | Jan. 22, 2014 | Jan. 22, 2014 | Jan. 31, 2015 | Jun. 30, 2010 | Sep. 30, 2015 | Sep. 30, 2015 | Mar. 04, 2015 | Dec. 31, 2014 | Aug. 31, 2012 |
Issued On January 22, 2014 [Member] | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Warrant period | 2 years | 2 years | 2 years | 2 years | |||||||
Warrants outstanding | 1,000,000 | 1,000,000 | |||||||||
Warrant exercise price (in dollars per warrant) | $ 9.70 | $ 9.70 | $ 3.445 | ||||||||
Senior Subordinated Notes [Member] | 4.25% Convertible Senior Subordinated Notes due August 15, 2019 [Member] | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Debt, interest rate | 4.25% | 4.25% | |||||||||
Debt, principal amount | $ 287,500,000 | $ 287,500,000 | $ 287,500,000 | $ 287,500,000 | |||||||
Balance of unamortized closing fees and expenses | 2,700,000 | 2,700,000 | 3,300,000 | ||||||||
Convertible debt | 196,371,000 | 196,371,000 | 182,395,000 | ||||||||
Secured Convertible Notes Due June 2015 [Member] | Deerfield Financing [Member] | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Debt, principal amount | $ 124,000,000 | ||||||||||
Balance of unamortized closing fees and expenses | 800,000 | 800,000 | 1,400,000 | ||||||||
Debt instruments, purchase price | 80,000,000 | ||||||||||
Debt instruments, closing fees and other expenses | 2,000,000 | ||||||||||
Debt instrument, principal payment | $ 4,000,000 | ||||||||||
Principal eligible for extension option | $ 100,000,000 | ||||||||||
Convertible debt | $ 101,900,000 | $ 101,900,000 | $ 104,000,000 | ||||||||
Debt instrument, interest rate, stated percentage after extension option election | 15.00% | 15.00% | |||||||||
Annual interest | $ 6,000,000 | ||||||||||
Debt instrument, effective interest rate | 15.27% | 15.27% | |||||||||
Percentage of revenue payable under collaborative arrangements | 15.00% | 15.00% | |||||||||
Maximum prepayment amount under collaborative arrangements | $ 27,500,000 | $ 27,500,000 | |||||||||
Mandatory prepayment under collaborative arrangement | 450,000 | ||||||||||
Development milestone payments received under collaborative arrangement | $ 3,000,000 | $ 3,000,000 | |||||||||
Secured Convertible Notes Due June 2015 [Member] | Deerfield Financing [Member] | Coupon Interest [Member] | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Debt instrument, interest rate, stated percentage after extension option election | 7.50% | 7.50% | |||||||||
Secured Convertible Notes Due June 2015 [Member] | Deerfield Financing [Member] | Payment-in-Kind Interest [Member] | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Debt instrument, interest rate, stated percentage after extension option election | 7.50% | 7.50% |
Common Stock and Warrants (Narr
Common Stock and Warrants (Narrative) (Details) - USD ($) $ / shares in Units, $ in Thousands | Jul. 29, 2015 | Mar. 18, 2015 | Jan. 22, 2014 | Jan. 22, 2014 | Sep. 30, 2015 | Sep. 30, 2015 | Sep. 30, 2014 | Mar. 04, 2015 | Dec. 31, 2014 |
Class of Warrant or Right [Line Items] | |||||||||
Public offering of common stock | 28,750,000 | ||||||||
Share price (in dollars per share) | $ 5.40 | ||||||||
Net proceeds from public offering | $ 145,600 | $ 145,651 | $ 75,646 | ||||||
Payments of stock issuance costs | $ 400 | ||||||||
Underwriter Over-Allotment Option [Member] | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Public offering of common stock | 3,750,000 | ||||||||
Underwriter over allotment period | 30 days | ||||||||
Issued On January 22, 2014 [Member] | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Warrants outstanding | 1,000,000 | 1,000,000 | |||||||
Warrant exercise price (in dollars per warrant) | $ 9.70 | $ 9.70 | $ 3.445 | ||||||
Warrant period | 2 years | 2 years | 2 years | 2 years | |||||
Warrant repricing terms on exercise of extension option | 120.00% | 120.00% | |||||||
Fair value of warrants | $ 1,500 | $ 900 | |||||||
Unrealized (loss) gain on warrants | $ (500) | $ 1,900 |
Fair Value Measurements (Schedu
Fair Value Measurements (Schedule Of Fair Value Of Financial Assets Measured On A Recurring Basis) (Details) - USD ($) $ in Thousands | Sep. 30, 2015 | Dec. 31, 2014 |
Financial assets: | ||
Total financial assets | $ 279,862 | $ 238,286 |
Financial liabilities: | ||
Warrants | 921 | |
Level 1 [Member] | ||
Financial assets: | ||
Total financial assets | 34,895 | 23,376 |
Financial liabilities: | ||
Warrants | 0 | |
Level 2 [Member] | ||
Financial assets: | ||
Total financial assets | 244,967 | 214,910 |
Financial liabilities: | ||
Warrants | 0 | |
Level 3 [Member] | ||
Financial assets: | ||
Total financial assets | 0 | |
Financial liabilities: | ||
Warrants | 0 | 921 |
Money market funds [Member] | ||
Financial assets: | ||
Total financial assets | 34,895 | 23,376 |
Money market funds [Member] | Level 1 [Member] | ||
Financial assets: | ||
Total financial assets | 34,895 | 23,376 |
Money market funds [Member] | Level 2 [Member] | ||
Financial assets: | ||
Total financial assets | 0 | 0 |
Money market funds [Member] | Level 3 [Member] | ||
Financial assets: | ||
Total financial assets | 0 | |
Commercial paper [Member] | ||
Financial assets: | ||
Total financial assets | 140,144 | 56,714 |
Commercial paper [Member] | Level 1 [Member] | ||
Financial assets: | ||
Total financial assets | 0 | 0 |
Commercial paper [Member] | Level 2 [Member] | ||
Financial assets: | ||
Total financial assets | 140,144 | 56,714 |
Commercial paper [Member] | Level 3 [Member] | ||
Financial assets: | ||
Total financial assets | 0 | |
Corporate bonds [Member] | ||
Financial assets: | ||
Total financial assets | 89,844 | 143,322 |
Corporate bonds [Member] | Level 1 [Member] | ||
Financial assets: | ||
Total financial assets | 0 | 0 |
Corporate bonds [Member] | Level 2 [Member] | ||
Financial assets: | ||
Total financial assets | 89,844 | 143,322 |
Corporate bonds [Member] | Level 3 [Member] | ||
Financial assets: | ||
Total financial assets | 0 | |
U.S. Treasury and government sponsored enterprises [Member] | ||
Financial assets: | ||
Total financial assets | 14,979 | 12,212 |
U.S. Treasury and government sponsored enterprises [Member] | Level 1 [Member] | ||
Financial assets: | ||
Total financial assets | 0 | 0 |
U.S. Treasury and government sponsored enterprises [Member] | Level 2 [Member] | ||
Financial assets: | ||
Total financial assets | $ 14,979 | 12,212 |
U.S. Treasury and government sponsored enterprises [Member] | Level 3 [Member] | ||
Financial assets: | ||
Total financial assets | 0 | |
Municipal bonds [Member] | ||
Financial assets: | ||
Total financial assets | 2,662 | |
Municipal bonds [Member] | Level 1 [Member] | ||
Financial assets: | ||
Total financial assets | 0 | |
Municipal bonds [Member] | Level 2 [Member] | ||
Financial assets: | ||
Total financial assets | 2,662 | |
Municipal bonds [Member] | Level 3 [Member] | ||
Financial assets: | ||
Total financial assets | $ 0 |
Fair Value Measurements (Fair V
Fair Value Measurements (Fair Value Schedule of Level 3 Changes) (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2015USD ($) | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |
Balance | $ 921 |
Level 3 [Member] | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |
Balance | 921 |
Unrealized loss at final re-measurement of warrants on March 18, 2015, included in Interest income and other, net | 549 |
Transfer of warrants from Other long-term liabilities to Additional paid-in capital at their estimated fair value upon warrant repricing on March 18, 2015 | (1,470) |
Balance | $ 0 |
Fair Value Measurements (Sche37
Fair Value Measurements (Schedule of Estimated Fair Value of Outstanding Debt) (Details) - USD ($) $ in Thousands | Sep. 30, 2015 | Dec. 31, 2014 |
Carrying Amount [Member] | Senior Subordinated Notes [Member] | 4.25% Convertible Senior Subordinated Notes due August 15, 2019 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair values of financial instruments | $ 196,371 | $ 182,395 |
Carrying Amount [Member] | Term Loan [Member] | Silicon Valley Bank term loan and Line of Credit [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair values of financial instruments | 80,000 | 80,000 |
Carrying Amount [Member] | Line of Credit [Member] | Silicon Valley Bank term loan and Line of Credit [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair values of financial instruments | 0 | 381 |
Carrying Amount [Member] | Secured Convertible Notes Due June 2015 [Member] | Deerfield Financing [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair values of financial instruments | 101,500 | |
Fair Value [Member] | Senior Subordinated Notes [Member] | 4.25% Convertible Senior Subordinated Notes due August 15, 2019 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair values of financial instruments | 355,638 | 156,889 |
Fair Value [Member] | Term Loan [Member] | Silicon Valley Bank term loan and Line of Credit [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair values of financial instruments | 79,884 | 79,943 |
Fair Value [Member] | Line of Credit [Member] | Silicon Valley Bank term loan and Line of Credit [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair values of financial instruments | 0 | $ 381 |
Fair Value [Member] | Secured Convertible Notes Due June 2015 [Member] | Deerfield Financing [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair values of financial instruments | $ 103,900 |
Fair Value Measurements (Sche38
Fair Value Measurements (Schedule of Assumptions Used) (Details) - Issued On January 22, 2014 [Member] | Mar. 18, 2015 | Dec. 31, 2014 | Jan. 22, 2014 | Jan. 22, 2014 | Sep. 30, 2015 | Sep. 30, 2015 |
Fair Value Inputs, Liabilities, Quantitative Information [Line Items] | ||||||
Warrant period | 2 years | 2 years | 2 years | 2 years | ||
Warrant liability [Member] | ||||||
Fair Value Inputs, Liabilities, Quantitative Information [Line Items] | ||||||
Fair value inputs, discount rate | 15.00% | |||||
Risk-free interest rate | 0.87% | 1.07% | ||||
Dividend yield | 0.00% | 0.00% | ||||
Volatility | 95.00% | 96.00% | ||||
Average expected life | 2 years 9 months 18 days | 3 years 1 month 6 days |
Stock-Based Compensation (Sched
Stock-Based Compensation (Schedule of Allocated Employee Stock-Based Compensation Expenses) (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Total employee stock-based compensation expense | $ 12,026 | $ 714 | $ 15,420 | $ 8,454 |
Research and development expense [Member] | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Total employee stock-based compensation expense | 6,676 | 112 | 8,049 | 3,148 |
Selling, general and administrative expense [Member] | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Total employee stock-based compensation expense | 5,350 | 624 | 7,371 | 5,328 |
Restructuring-related stock-based compensation (recovery) expense [Member] | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Total employee stock-based compensation expense | $ 0 | $ (22) | $ 0 | $ (22) |
Stock-Based Compensation (Sch40
Stock-Based Compensation (Schedule of Fair Value of Employee Share-Based Payments Awards Estimated Using the Assumptions and Weighted Average Fair Values) (Details) - $ / shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Employee Stock Option [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Weighted average grant date fair values (in dollars per share) | $ 3.92 | $ 1.19 | $ 2.51 | $ 1.47 |
Assumptions: | ||||
Risk-free interest rate | 1.18% | 1.83% | 1.20% | 1.81% |
Dividend yield | 0.00% | 0.00% | 0.00% | 0.00% |
Volatility | 88.00% | 86.00% | 93.00% | 85.00% |
Expected life | 4 years 7 months | 5 years 6 months | 4 years 6 months | 5 years 6 months |
Employee Stock Purchase Plan [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Weighted average grant date fair values (in dollars per share) | $ 1.26 | $ 1.21 | $ 0.97 | $ 1.35 |
Assumptions: | ||||
Risk-free interest rate | 0.06% | 0.05% | 0.09% | 0.06% |
Dividend yield | 0.00% | 0.00% | 0.00% | 0.00% |
Volatility | 107.00% | 68.00% | 101.00% | 66.00% |
Expected life | 6 months | 6 months | 6 months | 6 months |
Stock-Based Compensation (Narra
Stock-Based Compensation (Narrative) (Details) - USD ($) $ in Thousands | Jul. 20, 2015 | Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock-based compensation expense allocated | $ 12,026 | $ 714 | $ 15,420 | $ 8,454 | |
Employee Stock Option [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of shares available for grant | 6,980,194 | 6,980,194 | |||
Unrecognized compensation expense | $ 23,500 | $ 23,500 | |||
Unrecognized compensation expense, weighted-average period for recognition (in years) | 2 years 8 months 23 days | ||||
Performance Stock Options [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of stock options vested, in shares | 6,982,613 | ||||
Stock-based compensation expense allocated | $ 9,400 | ||||
Options outstanding, in shares | 5,934,063 | 5,934,063 | |||
Grant date fair value | $ 7,400 | $ 7,400 | |||
Restricted Stock Units (RSUs) [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Unrecognized compensation expense | $ 3,500 | $ 3,500 | |||
Unrecognized compensation expense, weighted-average period for recognition (in years) | 2 years 1 month 9 days |
Stock-Based Compensation (Summa
Stock-Based Compensation (Summary of All Stock Option Activity) (Details) $ / shares in Units, $ in Thousands | 9 Months Ended |
Sep. 30, 2015USD ($)$ / sharesshares | |
Shares [Roll Forward] | |
Options outstanding at beginning of period, Shares | 27,811,992 |
Granted, Shares | 8,505,300 |
Exercised, shares | (875,504) |
Forfeited, Shares | (924,890) |
Expired, Shares | (4,403,827) |
Options outstanding at end of period, Shares | 30,113,071 |
Exercisable at end of period, Shares | 18,385,413 |
Weighted Average Exercise Price [Roll Forward] | |
Options outstanding at beginning of period, Weighted Average Exercise Price (in dollars per share) | $ / shares | $ 5 |
Granted, Weighted Average Exercise Price (in dollars per share) | $ / shares | 3.70 |
Exercised, Weighted Average Exercise Price (in dollars per share) | $ / shares | 4.33 |
Forfeited, Weighted Average Exercise Price (in dollars per share) | $ / shares | 3.67 |
Expired, Weighted Average Exercise Price (in dollars per share) | $ / shares | 6.52 |
Options outstanding at end of period, Weighted Average Exercise Price (in dollars per share) | $ / shares | 4.48 |
Exercisable at end of period, Weighted Average Exercise Price (in dollars per share) | $ / shares | $ 5.06 |
Options outstanding at end of period, Weighted Average Remaining Contractual Term | 4 years 9 months 29 days |
Exercisable at end of period, Weighted Average Remaining Contractual Term | 3 years 10 months 20 days |
Options outstanding at end of period, Aggregate Intrinsic Value, in dollars | $ | $ 58,332 |
Exercisable at end of period, Aggregate Intrinsic Value, in dollars | $ | $ 29,649 |
Stock-Based Compensation (Sum43
Stock-Based Compensation (Summary of All RSU Activity) (Details) - Restricted Stock Units (RSUs) [Member] $ / shares in Units, $ in Thousands | 9 Months Ended |
Sep. 30, 2015USD ($)$ / sharesshares | |
Shares [Roll Forward] | |
RSUs outstanding at beginning of period, Shares | 961,469 |
Awarded, Shares | 673,785 |
Released, Shares | (414,694) |
Forfeited, Shares | (124,865) |
RSUs outstanding at end of period, Shares | 1,095,695 |
Weighted Average Grant DateFair Value [Roll Forward] | |
RSUs outstanding at beginning of period, Weighted Average Grant Date Fair Value (in dollars per share) | $ / shares | $ 3.82 |
Awarded, Weighted Average Grant Date Fair Value (in dollars per share) | $ / shares | 4.84 |
Released, Weighted Average Grant Date Fair Value (in dollars per share) | $ / shares | 3.62 |
Forfeited, Weighted Average Grant Date Fair Value (in dollars per share) | $ / shares | 5.32 |
RSUs outstanding at end of period, Weighted Average Grant Date Fair Value (in dollars per share) | $ / shares | $ 4.35 |
RSUs outstanding at end of period, Weighted Average Remaining Contractual Term | 2 years 1 month 9 days |
RSUs outstanding at end of period, Aggregate Intrinsic Value, in dollars | $ | $ 6,476 |
Net Loss Per Share (Details)
Net Loss Per Share (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Net loss, in dollars | $ (47,564) | $ (62,560) | $ (126,096) | $ (210,589) |
Shares used in computing basic and diluted net loss per share | 217,587 | 195,126 | 203,153 | 193,855 |
Net loss per share, basic and diluted, in dollars per share | $ (0.22) | $ (0.32) | $ (0.62) | $ (1.09) |
Total potentially dilutive shares | 120,339 | 110,977 | ||
Convertible debt [Member] | 4.25% Convertible Senior Subordinated Notes due August 15, 2019 [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total potentially dilutive shares | 54,118 | 54,118 | ||
Convertible debt [Member] | Secured Convertible Notes Due June 2015 [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total potentially dilutive shares | 33,890 | 21,616 | ||
Outstanding stock options, unvested RSUs and ESPP contributions [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total potentially dilutive shares | 31,331 | 34,243 | ||
Warrants [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total potentially dilutive shares | 1,000 | 1,000 |
Concentrations of Credit Risk45
Concentrations of Credit Risk (Details) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Concentration Risk [Line Items] | ||||
Product sales discounts and allowances | $ 1.8 | |||
Gain (loss) on foreign exchange fluctuations | $ 0.1 | $ 0.1 | ||
Customer Concentration Risk [Member] | Accounts Receivable [Member] | Diplomat Specialty Pharmacy [Member] | ||||
Concentration Risk [Line Items] | ||||
Concentration risk, percentage | 87.00% | |||
Customer Concentration Risk [Member] | Accounts Receivable [Member] | Swedish Orphan Biovitrum [Member] | ||||
Concentration Risk [Line Items] | ||||
Concentration risk, percentage | 13.00% | |||
Customer Concentration Risk [Member] | Sales [Member] | Diplomat Specialty Pharmacy [Member] | ||||
Concentration Risk [Line Items] | ||||
Concentration risk, percentage | 66.00% | 108.00% | 79.00% | 100.00% |
Customer Concentration Risk [Member] | Sales [Member] | Swedish Orphan Biovitrum [Member] | ||||
Concentration Risk [Line Items] | ||||
Concentration risk, percentage | 4.00% | (8.00%) | 10.00% | 0.00% |
Customer Concentration Risk [Member] | Revenue, Rights Granted [Member] | Merck [Member] | ||||
Concentration Risk [Line Items] | ||||
Concentration risk, percentage | 30.00% | 0.00% | 11.00% | 0.00% |
United States [Member] | Geographic Concentration Risk [Member] | Sales [Member] | ||||
Concentration Risk [Line Items] | ||||
Concentration risk, percentage | 96.00% | 108.00% | 90.00% | 100.00% |
European Union [Member] | Geographic Concentration Risk [Member] | Sales [Member] | ||||
Concentration Risk [Line Items] | ||||
Concentration risk, percentage | 4.00% | (8.00%) | 10.00% | 0.00% |