Document And Entity Information
Document And Entity Information - shares | 6 Months Ended | |
Jun. 30, 2016 | Jul. 28, 2016 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jul. 1, 2016 | |
Document Fiscal Year Focus | 2,016 | |
Document Fiscal Period Focus | Q2 | |
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 | --12-30 | |
Entity Common Stock, Shares Outstanding | 230,325,741 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2016 | Dec. 31, 2015 | [1] |
Current assets: | |||
Cash and cash equivalents | $ 129,827 | $ 141,634 | |
Short-term investments | 198,292 | 25,426 | |
Trade and other receivables | 17,799 | 5,183 | |
Inventory | 2,808 | 2,616 | |
Prepaid expenses and other current assets | 4,657 | 3,806 | |
Total current assets | 353,383 | 178,665 | |
Long-term investments | 51,727 | 83,600 | |
Long-term restricted cash and investments | 4,150 | 2,650 | |
Property and equipment, net | 1,982 | 1,434 | |
Goodwill | 63,684 | 63,684 | |
Other long-term assets | 2,210 | 2,309 | |
Total assets | 477,136 | 332,342 | |
Current liabilities: | |||
Accounts payable | 5,435 | 6,401 | |
Accrued collaboration liability | 16,993 | 10,938 | |
Accrued clinical trial liabilities | 15,681 | 18,071 | |
Accrued compensation and benefits | 10,307 | 3,629 | |
Current portion of term loan payable | 80,000 | 0 | |
Current portion of convertible notes | 27,500 | 0 | |
Current portion of deferred revenue | 14,631 | 0 | |
Other accrued liabilities | 22,248 | 13,212 | |
Total current liabilities | 192,795 | 52,251 | |
Long-term portion of convertible notes | 288,555 | 301,435 | |
Long-term portion of term loan payable | 0 | 80,000 | |
Long-term portion of deferred revenue | 180,838 | 0 | |
Other long-term liabilities | 1,082 | 2,960 | |
Total liabilities | 663,270 | 436,646 | |
Commitments | |||
Stockholders’ deficit: | |||
Preferred stock | 0 | 0 | |
Common stock, $0.001 par value; 400,000,000 shares authorized; issued and outstanding: 230,241,106 and 227,960,943 shares at June 30, 2016 and December 31, 2015, respectively | 230 | 228 | |
Additional paid-in capital | 1,848,910 | 1,832,741 | |
Accumulated other comprehensive income (loss) | 129 | (232) | |
Accumulated deficit | (2,035,403) | (1,937,041) | |
Total stockholders’ deficit | (186,134) | (104,304) | |
Total liabilities and stockholders’ deficit | $ 477,136 | $ 332,342 | |
[1] | The condensed consolidated balance sheet as of December 31, 2015 has been derived from the audited financial statements as of that date. |
Condensed Consolidated Balance3
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2016 | Dec. 31, 2015 |
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 | 230,241,106 | 227,960,943 |
Common stock, shares outstanding | 230,241,106 | 227,960,943 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Revenues: | ||||
Net product revenues | $ 31,618 | $ 7,992 | $ 40,717 | $ 17,380 |
Royalty, license and contract revenues | 4,634 | 0 | 10,962 | 0 |
Total revenues | 36,252 | 7,992 | 51,679 | 17,380 |
Operating expenses: | ||||
Cost of goods sold | 1,560 | 686 | 2,245 | 1,452 |
Research and development | 22,984 | 24,506 | 51,910 | 46,788 |
Selling, general and administrative | 35,823 | 12,789 | 70,680 | 22,320 |
Restructuring charge | 1,021 | 1,291 | 1,115 | 860 |
Total operating expenses | 61,388 | 39,272 | 125,950 | 71,420 |
Loss from operations | (25,136) | (31,280) | (74,271) | (54,040) |
Other income (expense), net: | ||||
Interest income and other, net | 749 | (123) | 951 | (130) |
Interest expense | (12,628) | (11,959) | (25,042) | (24,362) |
Total other income (expense), net | (11,879) | (12,082) | (24,091) | (24,492) |
Net loss | $ (37,015) | $ (43,362) | $ (98,362) | $ (78,532) |
Net loss per share, basic and diluted, in dollars per share | $ (0.16) | $ (0.22) | $ (0.43) | $ (0.40) |
Shares used in computing basic and diluted net loss per share, in shares | 229,310 | 196,201 | 228,860 | 196,052 |
Condensed Consolidated Stateme5
Condensed Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | ||
Statement of Comprehensive Income [Abstract] | |||||
Net loss | $ (37,015) | $ (43,362) | $ (98,362) | $ (78,532) | |
Other comprehensive income (loss) | [1] | 171 | (113) | 361 | (53) |
Comprehensive loss | $ (36,844) | $ (43,475) | $ (98,001) | $ (78,585) | |
[1] | Other comprehensive income (loss) consisted solely of unrealized gains or losses, net on available for sale securities arising during the periods presented. There were no reclassification adjustments to net loss resulting from realized gains or losses on the sale of securities and there was no income tax expense related to other comprehensive income during those periods. |
Condensed Consolidated Stateme6
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | ||
Cash flows from operating activities: | |||
Net loss | $ (98,362) | $ (78,532) | |
Adjustments to reconcile net loss to net cash provided by (used in) operating activities: | |||
Depreciation and amortization | 456 | 684 | |
Stock-based compensation expense | 14,743 | 3,394 | |
Accretion of debt discount and debt issuance costs | 10,712 | 14,891 | |
Accrual of interest paid in kind | 3,908 | 0 | |
Gain on sale of equity investment | 0 | (95) | |
Change in the fair value of warrants | 0 | 549 | |
Other | (1,138) | 1,093 | |
Changes in assets and liabilities: | |||
Trade and other receivables | (12,361) | 746 | |
Inventory | (192) | (227) | |
Prepaid expenses and other current assets | (851) | 751 | |
Other long term assets | 99 | 202 | |
Accounts payable, accrued compensation and benefits, and other accrued liabilities | 14,289 | (6,563) | |
Accrued collaboration liability | 6,055 | 6,968 | |
Clinical trial liabilities | (2,390) | (8,973) | |
Restructuring liability | (927) | (3,321) | |
Deferred revenue | 195,469 | (2,583) | |
Other long-term liabilities | (493) | (903) | |
Net cash provided by (used in) operating activities | 129,017 | (71,919) | |
Cash flows from investing activities: | |||
Purchases of property and equipment | (1,083) | (94) | |
Proceeds from sale of property and equipment | 112 | 1,295 | |
Proceeds from equity investment | 0 | 95 | |
Proceeds from maturities of restricted cash and investments | 2,650 | 12,247 | |
Purchase of restricted cash and investments | (4,150) | (4,184) | |
Proceeds from sale of investments | 17 | 0 | |
Proceeds from maturities of investments | 58,340 | 94,438 | |
Purchases of investments | (199,396) | (46,217) | |
Net cash (used in) provided by investing activities | (143,510) | 57,580 | |
Cash flows from financing activities: | |||
Proceeds from exercise of stock options | 2,207 | 0 | |
Proceeds from employee stock purchase plan | 479 | 274 | |
Principal payments on debt | 0 | (4,381) | |
Net cash provided by (used in) financing activities | 2,686 | (4,107) | |
Net decrease in cash and cash equivalents | (11,807) | (18,446) | |
Cash and cash equivalents at beginning of period | 141,634 | [1] | 80,395 |
Cash and cash equivalents at end of period | $ 129,827 | $ 61,949 | |
[1] | The condensed consolidated balance sheet as of December 31, 2015 has been derived from the audited financial statements as of that date. |
Organization and Summary of Sig
Organization and Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2016 | |
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 the discovery, development and commercialization of new medicines that will improve care and outcomes for people with cancer. Since its founding in 1994, three products discovered at Exelixis have progressed through clinical development, received regulatory approval, and entered the commercial marketplace. This portfolio includes two products derived from cabozantinib, an inhibitor of multiple tyrosine kinases including MET, AXL and VEGF receptors. They are CABOMETYX™ tablets for the treatment of advanced kidney cancer in the United States and COMETRIQ ® capsules for the treatment of certain forms of thyroid cancer in both the United States and European Union. The third product is COTELLIC ® , a product derived from cobimetinib, a selective inhibitor of MEK, marketed under a collaboration with Roche and Genentech (a member of the Roche Group) that has been approved in combination with ZELBORAF ® (vemurafenib) to treat advanced melanoma in several major territories, including the United States and European Union. Basis of Consolidation The condensed 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 condensed 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 periods presented have been included. We adopted a 52- or 53-week fiscal year that generally ends on the Friday closest to December 31 st . Fiscal year 2016 will end on December 30, 2016, and fiscal year 2015, ended on January 1, 2016. For convenience, references in this report as of and for the fiscal periods ended September 30, 2016, July 1, 2016 and July 3, 2015, and as of and for the fiscal years ended December 30, 2016 and January 1, 2016, are indicated as being as of and for the periods ended September 30, 2016, June 30, 2016, June 30, 2015, and the years ended December 31, 2016, and December 31, 2015, respectively. Operating results for the six months ended June 30, 2016 are not necessarily indicative of the results that may be expected for the year ending December 31, 2016 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, 2015 , included in our Annual Report on Form 10-K filed with the SEC on February 29, 2016 . 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 revenue recognition, including for deductions from revenues (such as rebates, chargebacks, sales returns and sales allowances) and the period of performance, identification of deliverables and evaluation of milestones with respect to our collaborations , recoverability of inventory, certain accrued liabilities including clinical trial and collaboration liability accruals, and share-based compensation. 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. Limited Sources of Revenues and the Need to Raise Additional Capital We have incurred net losses since inception through June 30, 2016 , with the exception of the 2011 fiscal year. We anticipate annual net losses for the foreseeable future. For the six months ended June 30, 2016 , we incurred a net loss of $98.4 million and as of June 30, 2016 , we had an accumulated deficit of $2.0 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. Excluding fiscal 2011, our research and development expenditures and selling, general and administrative expenses have exceeded our revenues for each 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. Since the launch of our first commercial product in January 2013, through June 30, 2016 , we have generated an aggregate of $115.0 million in net product revenues. Other than sales of CABOMETYX and COMETRIQ, we have derived substantially all of our revenues since inception from collaborative research and development agreements, which depend on royalties, license fees, the achievement of milestones, and research funding we earn from any products developed from the collaborative research. The amount of our net losses will depend, in part, on: the level of sales of CABOMETYX in the U.S. for the treatment of advanced renal cell carcinoma (“RCC”) ; our sales of COMETRIQ; achievement of clinical, regulatory and commercial milestones and the amount of royalties, if any, from sales of cabozantinib under our collaboration with Ipsen Pharma SAS (“Ipsen”); our share of the net profits and losses for the commercialization of COTELLIC in the U.S. under our collaboration with Genentech (a member of the Roche group); the amount of royalties from COTELLIC sales outside the U.S. under our collaboration with Genentech; other license and contract revenues; and, the level of our expenses, primarily with respect to expanded commercialization activities for cabozantinib. As of June 30, 2016 , we had $384.0 million in cash and investments, which included $298.2 million available for operations, $81.6 million of compensating balance investments that we are required to maintain on deposit with Silicon Valley Bank, and $4.2 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 filing date of this report. 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 product sales and from license fees, milestones, contingent payments and royalties earned on research, collaboration and license arrangements. 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, 2015 for a description of our revenue recognition policies for product sales discounts and allowances, license and contract revenues under our collaboration agreement with Genentech and our Patient Assistance Program. 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 a specialty pharmacy or distributor. For product sales in Europe, this generally occurs when our European distribution partner, Swedish Orphan Biovitrum (“Sobi”), has accepted the product. In the United States, we sell our products, CABOMETYX and COMETRIQ, to specialty pharmacies and distributors that benefit from customer incentives and have 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 a single specialty pharmacy, therefore we recognized revenue when the specialty pharmacy provided the product to a patient based on the fulfillment of a prescription, which is frequently referred to as the “sell-through” revenue recognition model. In January 2015, we established that we had sufficient historical experience and data to reasonably estimate expected future returns of COMETRIQ 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 the 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 that had previously been deferred under the “sell-through” revenue recognition model, resulting in the additional recognition of gross product revenues of $2.6 million for the six months ended June 30, 2015 ; there were no such additional amounts recorded during the comparable period in 2016 . In determining discounts and allowances for the initial launch and sale of CABOMETYX, in addition to using payer data received from the specialty pharmacies and distributors that sell CABOMETYX and historical data for COMETRIQ, we also utilized claims data from third party sources for competitor products for the treatment of advanced RCC. Based in part on the availability of this third party data, we made the determination that we had sufficient experience and data to reasonably estimate expected future returns and the discounts and allowances due to payers at the time of shipment to the specialty pharmacy or distributor, and therefore record revenue for the product using the “sell-in” revenue recognition model. Net product revenues during the three and six months ended June 30, 2016 was impacted by the build of channel inventory related to the initial launch period for CABOMETYX. We also utilize the “sell-in” revenue recognition model for sales to Sobi for all periods presented. Once Sobi has accepted the product, the product is generally no longer subject to return; therefore, we record revenue at the time Sobi has accepted the product. As described further in “Note 2 - Research and Collaboration Agreements”, under the terms of our collaboration and license agreement with Ipsen for the commercialization and further development of cabozantinib, we provided Sobi with a notice of termination of our distribution and commercial agreement for COMETRIQ which will become effective during the fourth quarter of 2016. Pursuant to our commercialization agreement with Sobi, we expect to repurchase the remaining product on hand from Sobi at the termination of that agreement. As of June 30, 2016 , we recorded reserves for expected future returns totaling $0.7 million ; there were no such reserves recorded as of December 31, 2015 or June 30, 2015 . Royalty, License and Contract Revenues We enter into corporate collaboration and license agreements under which we may obtain upfront license fees, research funding, and contingent, milestone and royalty payments. Our deliverables under these arrangements may include intellectual property rights, distribution rights, delivery of manufactured product, participation on joint steering committees and/or research and development services. In order to account for the multiple-element arrangements, we identify the deliverables included within the arrangement and evaluate whether the delivered elements under these arrangements have value to our collaboration partner on a stand-alone basis and represent separate units of accounting. Analyzing the arrangement to identify deliverables requires the use of judgment, and each deliverable may be an obligation to deliver future goods or services, a right or license to use an asset, or another performance obligation. If we determine that multiple deliverables exist, the consideration is allocated to one or more units of accounting based upon the best estimate of the selling price of each deliverable. The selling price used for each deliverable will be based on vendor-specific objective evidence, if available, third-party evidence if vendor-specific objective evidence is not available, or estimated selling price if neither vendor-specific or third-party evidence is available. A delivered item or items that do not qualify as a separate unit of accounting within the arrangement shall be combined with the other applicable undelivered items within the arrangement. The allocation of arrangement consideration and the recognition of revenue then shall be determined for those combined deliverables as a single unit of accounting. For a combined unit of accounting, non-refundable upfront fees are recognized in a manner consistent with the final deliverable, which has generally been ratably over the period of continued involvement. Amounts received in advance of performance are recorded as deferred revenue. Upfront fees are classified as license revenues in our consolidated statements of operations. We consider sales-based contingent payments to be royalty revenue which is generally recognized at the date the contingency is achieved. Royalties are recorded based on sales amounts reported to us for the preceding quarter. For certain contingent payments under collaboration and license arrangements, we recognize revenue using the milestone method. Under the milestone method a payment that is contingent upon the achievement of a substantive milestone is recognized in its entirety in the period in which the milestone is achieved. A milestone is an event: (i) that can be achieved based in whole or in part on either our performance or on the occurrence of a specific outcome resulting from our performance, (ii) for which there is substantive uncertainty at the date the arrangement is entered into that the event will be achieved and (iii) that would result in additional payments being due to us. The determination that a milestone is substantive requires estimation and judgment and is made at the inception of the arrangement. Milestones are considered substantive when the consideration earned from the achievement of the milestone is: (i) commensurate with either our performance to achieve the milestone or the enhancement of value of the item delivered as a result of a specific outcome resulting from our performance to achieve the milestone, (ii) relates solely to past performance and (iii) reasonable relative to all deliverables and payment terms in the arrangement. In making the determination as to whether a milestone is substantive or not, we consider all facts and circumstances relevant to the arrangement, including factors such as the scientific, regulatory, commercial and other risks that must be overcome to achieve the respective milestone, the level of effort and investment required to achieve the respective milestone and whether any portion of the milestone consideration is related to future performance or deliverables. Recently Adopted Accounting Pronouncements In April 2015, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update No. 2015-05, Customer’s Accounting for Fees Paid in a Cloud Computing Arrangement , (“ASU 2015-05”) . ASU 2015-05 provides guidance to customers about whether a cloud computing arrangement includes a software license. If a cloud computing arrangement includes a software license, then the customer should account for the software license element of the arrangement consistent with the acquisition of other software licenses. If a cloud computing arrangement does not include a software license, the customer should account for the arrangement as a service contract. ASU 2015-05 was effective for all interim and annual reporting periods beginning after December 15, 2015 and therefore we adopted ASU 2015-05 in the three months ended March 31, 2016 on a prospective basis. The adoption of ASU 2015-05 did not have a material impact on our Condensed Consolidated Statements of Operations during the period of adoption and is not expected to have a material effect on our Consolidated Financial Statements in future periods. Recently Issued Accounting Pronouncements In March 2016, the FASB issued Accounting Standards Update No. 2016-09, Improvements to Employee Share-Based Payment Accounting , (“ASU 2016-09”) . ASU 2016-09 is aimed at the simplification of several aspects of the accounting for employee share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities, and classification on the statement of cash flows. ASU 2016-09 is effective for all interim and annual reporting periods beginning after December 15, 2016. Early adoption is permitted. We are currently evaluating the impact that the adoption of ASU 2016-09 will have on our consolidated financial statements and related disclosures. |
Research and Collaboration Agre
Research and Collaboration Agreements | 6 Months Ended |
Jun. 30, 2016 | |
Research And Collaboration Agreements [Abstract] | |
Research and Collaboration Agreements | RESEARCH AND COLLABORATION AGREEMENTS Ipsen Collaboration On February 29, 2016, we entered into a collaboration and license agreement (the “Agreement”) with Ipsen for the commercialization and further development of cabozantinib. Pursuant to the terms of the Agreement, Ipsen will have exclusive commercialization rights for current and potential future cabozantinib indications outside of the United States, Canada and Japan. We have agreed to collaborate on the development of cabozantinib for current and potential future indications. In consideration for the exclusive license and other rights contained in the Agreement, Ipsen paid us an upfront nonrefundable payment of $200.0 million in March 2016. We will be eligible to receive development and regulatory milestones, totaling up to $252.5 million , including a $60.0 million milestone payment upon approval of cabozantinib by the European Medicines Agency (“EMA”) in second-line RCC, milestone payments of $10.0 million and $40.0 million upon the filing and the approval of cabozantinib in second-line hepatocellular carcinoma, and additional milestones for other future indications. We will also be eligible to receive two $10.0 million milestone payments upon the launch of the product in the first two of the following countries: Germany, France, Italy, Spain and the United Kingdom. The Agreement also provides that we will be eligible to receive contingent payments of up to $525.0 million associated with the achievement of specified sales levels. We will also receive royalties on net sales of cabozantinib outside of the United States, Canada and Japan. We will receive a 2% royalty on the initial $50.0 million of net sales, and a 12% royalty on the next $100.0 million of net sales. After the initial $150.0 million of sales, we will receive a tiered royalty of 22% to 26% on annual net sales; these tiers will reset each calendar year. We are primarily responsible for funding cabozantinib related development costs for existing trials; global development costs for potential future trials will be shared between the parties, with Ipsen to reimburse us for 35% of such costs. Pursuant to the terms of the Agreement, we will remain responsible for the manufacture and supply of cabozantinib for all development and commercialization activities under the Agreement. As part of the Agreement, we entered into a supply agreement which provides that through the end of the second quarter of 2018, we will supply finished, labeled product to Ipsen for distribution in the territories outside of the United States, Canada and Japan, and from the end of the second quarter of 2018 forward, we will supply primary packaged bulk tablets to Ipsen. No manufacturing rights were granted to Ipsen. The agreement contains multiple elements, and the deliverables under the Agreement consist of intellectual property licenses, delivery of cabozantinib to Ipsen for all development and commercial activities, research and development services, and participation on the joint steering and development committees (as defined in the Agreement) with Ipsen. These deliverables are non-contingent in nature. The Company determined that these deliverables do not have stand-alone value, because each one of them has value only if the Company meets its obligation to provide Ipsen with cabozantinib, which the Company deems to be the predominant deliverable under the Agreement. The Company also determined that the level of effort required of the Company to meet its obligations under the Agreement is not expected to vary significantly over the life of the Agreement. Accordingly, the Company combined these deliverables into a single unit of accounting and allocated the entire arrangement consideration to that combined unit of accounting. As a result, the upfront payment of $200.0 million , received in the first quarter of 2016 is being recognized ratably over the effective term of the agreement, which is early 2030, the current estimated patent expiration of cabozantinib in the European Union. We have also determined that the $60.0 million milestone payment we are eligible to receive upon the approval of cabozantinib by the EMA in second-line RCC is not substantive due to the relatively low degree of uncertainty and relatively low amount of effort required on our part to achieve the milestone as of the date the agreement; upon achieving the milestone, the $60.0 million to which we are contractually entitled will be deferred and recognized ratably over the remaining term of the Agreement. We have determined that the remaining development and regulatory milestones are substantive and will be recognized as revenue in the periods in which they are achieved. We consider the contingent payments due to us upon the achievement of specified sales volumes to be similar to royalty payments. Subsequent to February 29, 2016, we transferred the intellectual property rights to Ipsen, and participated in steering committee meetings which activities included regulatory filing activities, and planning for the production, delivery and distribution of manufactured product and therefore have begun recognition of the upfront payment under the Agreement. During the three and six months ended June 30, 2016 , we have recognized $3.6 million and $4.8 million , respectively, in license revenue under the Agreement. As of June 30, 2016 , short-term and long-term deferred revenue relating to the Agreement was $14.4 million and $180.8 million , respectively. In connection with the establishment of the Agreement with Ipsen, we provided Sobi with a notice of termination of our distribution and commercialization agreement for COMETRIQ which will become effective during the fourth quarter of 2016, as Ipsen will become responsible for the continued distribution and commercialization of COMETRIQ for the approved medullary thyroid cancer indication in territories supported by Sobi. Pursuant to our commercialization agreement with Sobi we are required to pay a termination fee. As of June 30, 2016 , we had a $2.7 million accrual for the estimated termination fee to be paid to Sobi, the related expense, which was recorded during the three months ended March 31, 2016, is included in Selling, general and administrative expenses in the accompanying Condensed Consolidated Statements of Operations. Additionally, pursuant to our commercialization agreement with Sobi, we expect to repurchase unsold product from Sobi and have recorded a returns reserve of $0.5 million as of June 30, 2016 , the related charge for which is included in Net product revenues in the accompanying Condensed Consolidated Statements of Operations. Genentech Collaboration In December 2006, we out-licensed the development and commercialization of cobimetinib to Genentech (a member of the Roche group) pursuant to a worldwide collaboration agreement. We discovered cobimetinib internally and advanced the compound to investigational new drug (“IND”) status. Genentech paid upfront and milestone payments of $25.0 million in December 2006 and $15.0 million in January 2007 upon signing of the collaboration agreement and with the submission of the IND application for cobimetinib. Under the terms of the agreement, we were responsible for developing cobimetinib through the determination of the maximum-tolerated dose in a phase 1 clinical trial, and Genentech had the option to co-develop cobimetinib, which Genentech could exercise after receipt of certain phase 1 data from us. In March 2008, Genentech exercised its option to co-develop cobimetinib. In March 2009, we granted to Genentech an exclusive worldwide revenue-bearing license to cobimetinib, at which point Genentech became responsible for completing the phase 1 clinical trial and subsequent clinical development. The U.S. Food and Drug Administration (“FDA”) approved cobimetinib in the United States under the brand name COTELLIC on November 10, 2015. It is indicated in combination with vemurafenib as a treatment for patients with BRAF V600E or V600K mutation-positive advanced melanoma. COTELLIC in combination with vemurafenib has also been approved in multiple other territories including the European Union and Canada. Under the terms of our collaboration agreement with Genentech for cobimetinib, we are entitled to a share of U.S. profits and losses for cobimetinib. The profit and loss share has multiple tiers: we are entitled to 50% of profits and losses from the first $200.0 million of U.S. actual sales, decreasing to 30% of profits and losses from U.S. actual sales in excess of $400.0 million . We are entitled to low double-digit royalties on ex-U.S. net sales. In November 2013, we exercised an option under the collaboration agreement to co-promote in the United States. Following the approval of COTELLIC in the United States in November 2015, we began fielding 25% of the sales force promoting COTELLIC in combination with vemurafenib as a treatment for patients with BRAF V600E or V600K mutation-positive advanced melanoma. We recorded net losses of $4.6 million and $11.9 million under the collaboration agreement during the three and six months ended June 30, 2016 , respectively as compared to $4.0 million and $7.0 million for the comparable periods in 2015 ; those costs are included in Selling, general and administrative expenses on the accompanying Condensed Consolidated Statements of Operations. A portion of the liability for those costs, identified as Accrued collaboration liability on the accompanying Condensed Consolidated Balance Sheets, includes commercialization expenses that Genentech has allocated to the collaboration but are in dispute. On June 3, 2016, we filed a Demand for Arbitration before JAMS in San Francisco, California asserting claims against Genentech related to its clinical development, pricing and commercialization of COTELLIC, and cost and revenue allocations arising from COTELLIC’s commercialization in the United States. Our arbitration demand asserts that Genentech has breached the parties’ contract for, amongst other breaches, failing to meet its diligence and good faith obligations. The demand seeks various forms of declaratory, monetary, and equitable relief, including without limitation that the cost and revenue allocations for COTELLIC be shared equitably consistent with the collaboration agreement’s terms, along with attorneys’ fees and costs of the arbitration. Genentech has asserted a counterclaim for breach of contract, which seeks monetary damages and interest related to the cost allocations under the collaboration agreement. While the ultimate outcome of the arbitration is difficult to predict, a resolution of the matter adverse to us could result in, among other things, significant payments and higher than expected commercialization costs, which may have a material adverse effect on our results of operations, cash flows or financial condition. We also recognized license revenues of $1.0 million and $1.2 million for royalties on ex-U.S. net sales of COTELLIC during the three and six months ended June 30, 2016 , respectively, based on sales amounts reported by Genentech for the preceding quarter. We recognized no such royalties during the comparable periods in 2015. Other Collaborations During the six months ended June 30, 2016 , we recognized $5.0 million in contract revenues from a contingent payment received from Merck related to its worldwide license of our phosphoinositide-3 kinase-delta program. There was no such contract revenue during the three months ended June 30, 2016 or the comparable periods in 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, 2015 for a description of our existing collaboration agreements. |
Restructurings
Restructurings | 6 Months Ended |
Jun. 30, 2016 | |
Restructuring Charges [Abstract] | |
Restructurings | RESTRUCTURINGS Between March 2010 and May 2013, we implemented five restructurings (which we refer 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. In September 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 a restructuring (which we refer to as the “2014 Restructuring”) to enable us to focus our financial resources on the phase 3 pivotal trials of cabozantinib in advanced RCC and advanced hepatocellular carcinoma. See “Note 3 - Restructurings” to our Consolidated Financial Statements included in our Annual Report on Form 10-K for the year ended December 31, 2015 for additional information about the restructurings. For the six months ended June 30, 2016 and 2015 , we recorded a restructuring charge of $1.1 million and $0.9 million , respectively, for the restructurings. Both periods included 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 three and six months ended June 30, 2016 , the restructuring charge also included $1.0 million in additional charges related to a decrease in anticipated proceeds under one of our existing subleases due to a tenant’s default on the sublease. During the six months ended June 30, 2015 , the restructuring charge also included $1.8 million in additional charges due to the partial termination of one of our building leases, the impact of a new sublease executed in June 2015, changes in assumptions regarding anticipated sublease activities and additional facility-related charges related to the decommissioning and exit of certain buildings; the 2015 restructuring charge was partially offset by $0.9 million in recoveries recorded in connection with the sale of excess equipment and other assets. The total outstanding restructuring liability is included in the current and long-term portion of restructuring on the accompanying Condensed Consolidated Balance Sheets. The changes of these liabilities during the six months ended June 30, 2016 , which related primarily to facilities, are summarized in the following table (in thousands): 2010 Restructurings 2014 Restructuring Total Restructuring liability as of December 31, 2015 $ 4,087 $ 503 $ 4,590 Restructuring charge 1,106 9 1,115 Proceeds from sale of assets — 34 34 Cash payments, net (1,694 ) (347 ) (2,041 ) Other items — (34 ) (34 ) Restructuring liability as of June 30, 2016 $ 3,499 $ 165 $ 3,664 We expect to pay accrued facility charges of $3.7 million , net of cash received from our subtenants, through the end of the lease terms of the buildings, all of which end in May 2017. We expect to incur additional restructuring charges of approximately $0.1 million relating to the effect of accretion expense through to the end of the lease terms of the buildings. |
Cash and Investments
Cash and Investments | 6 Months Ended |
Jun. 30, 2016 | |
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 June 30, 2016 and December 31, 2015 (in thousands): June 30, 2016 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Cash and cash equivalents $ 129,827 $ — $ — $ 129,827 Short-term investments 198,148 150 (6 ) 198,292 Long-term investments 51,636 96 (5 ) 51,727 Long-term restricted cash and investments 4,150 — — 4,150 Total cash and investments $ 383,761 $ 246 $ (11 ) $ 383,996 December 31, 2015 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Cash and cash equivalents $ 141,634 $ — $ — $ 141,634 Short-term investments 25,484 5 (63 ) 25,426 Long-term investments 83,665 2 (67 ) 83,600 Long-term restricted cash and investments 2,650 — — 2,650 Total cash and investments $ 253,433 $ 7 $ (130 ) $ 253,310 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 were $81.6 million as of both June 30, 2016 and December 31, 2015 and are reflected in our Condensed Consolidated Balance Sheets in short-term investments as of June 30, 2016 and long-term investments as of December 31, 2015 ; the change in classification from long-term to short-term was the result of a corresponding change in the classification for our term loan payable to Silicon Valley Bank which matures in May 2017. See “Note 7 - Debt” to our Consolidated Financial Statements included in our Annual Report on Form 10-K for the year ended December 31, 2015 , for more information regarding the collateral balance requirements under our Silicon Valley Bank loan and security agreement. As part of a purchasing card program with a bank we initiated during 2007, we are required to provide collateral in the form of a non-interest bearing certificate of deposit. Long-term restricted cash and investments includes a $1.5 million certificate of deposit acquired during the three months ended June 30, 2016 in order to expand the program which we expect to pledge as collateral under the program shortly after June 30, 2016 . The following tables summarize our cash equivalents and investments by security type as of June 30, 2016 and December 31, 2015 . The amounts presented exclude cash, but include investments classified as cash equivalents (in thousands): June 30, 2016 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Money market funds $ 27,517 $ — $ — $ 27,517 Commercial paper 163,062 — — 163,062 Corporate bonds 120,389 150 (11 ) 120,528 U.S. Treasury and government sponsored enterprises 63,587 96 — 63,683 Total investments $ 374,555 $ 246 $ (11 ) $ 374,790 December 31, 2015 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Money market funds $ 72,000 $ — $ — $ 72,000 Commercial paper 78,155 — — 78,155 Corporate bonds 72,205 4 (118 ) 72,091 U.S. Treasury and government sponsored enterprises 28,434 1 (12 ) 28,423 Marketable equity security 16 2 — 18 Total investments $ 250,810 $ 7 $ (130 ) $ 250,687 All of our investments are subject to a quarterly impairment review. During the six months ended June 30, 2016 and 2015 , we did no t record any other-than-temporary impairment charges on our available-for-sale securities. As of June 30, 2016 , there were six investments in an unrealized loss position with gross unrealized losses of $11,000 and an aggregate fair value of $13.1 million . The investments in an unrealized loss position are comprised of corporate bonds. 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 June 30, 2016 (in thousands): Mature within One Year After One Year through Two Years Fair Value Money market funds $ 27,517 $ — $ 27,517 Commercial paper 163,062 — 163,062 Corporate bonds 72,806 47,722 120,528 U.S. Treasury and government sponsored enterprises 59,678 4,005 63,683 Total investments $ 323,063 $ 51,727 $ 374,790 Cash is excluded from the table above. |
Inventory
Inventory | 6 Months Ended |
Jun. 30, 2016 | |
Inventory Disclosure [Abstract] | |
Inventory | INVENTORY Inventory consists of the following (in thousands): June 30, December 31, Raw materials $ 973 $ 1,037 Work in process 2,277 2,251 Finished goods 714 583 Total 3,964 3,871 Less: non-current portion included in Other assets (1,156 ) (1,255 ) Inventory $ 2,808 $ 2,616 We generally relieve inventory on a first-expiry, first-out basis. A portion of the manufacturing costs for inventory was incurred prior to regulatory approval of CABOMETYX and COMETRIQ and, therefore, were expensed as research and development costs when those costs were incurred, rather than capitalized as inventory. Write-downs related to expiring inventory are charged to cost of goods sold. Such write-downs were nominal for the six months ended June 30, 2016 as compared to $0.2 million for the comparable period in 2015 . The non-current portion of inventory recorded as other assets consists of raw materials and a portion of the active pharmaceutical ingredient which is included in work in process. There were no other write-downs for obsolete or excess inventory. |
Debt
Debt | 6 Months Ended |
Jun. 30, 2016 | |
Debt Disclosure [Abstract] | |
Debt | DEBT The amortized carrying amount of our debt consists of the following (in thousands): June 30, December 31, Convertible Senior Subordinated Notes due 2019 $ 209,214 $ 198,708 Secured Convertible Notes due 2018 106,841 102,727 Term loan payable 80,000 80,000 Total debt 396,055 381,435 Less: current portion (107,500 ) — Long-term debt $ 288,555 $ 381,435 See “Note 7 - Debt” to our Consolidated Financial Statements included in our Annual Report on Form 10-K for the year ended December 31, 2015 , 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 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 both June 30, 2016 and December 31, 2015 , $287.5 million of aggregate principal amount of the 2019 Notes remains outstanding. The 2019 Notes bear interest at a rate of 4.25% per annum, payable semi-annually in arrears on February 15 and August 15 of each year. The following is a summary of the liability component of the 2019 Notes (in thousands): June 30, December 31, Net carrying amount of the liability component $ 209,214 $ 198,708 Unamortized discount of the liability component 78,286 88,792 Face amount of the 2019 Notes $ 287,500 $ 287,500 The 2019 Notes are convertible at the note-holder’s option during the quarter ending September 30, 2016 as one of the conversion criteria has been met. Specifically, the price of our common stock exceeded $6.91 for 20 of the last 30 consecutive trading days during the quarter ended June 30, 2016 . The continuance of such conversion rights subsequent to September 30, 2016 is subject to the occurrence of certain circumstances. The 2019 Notes are convertible at a conversion rate of 188.2353 shares of common stock per $1,000 principal amount of the 2019 Notes, subject to adjustment in connection with certain events. Upon conversion, we have the option to pay or deliver, as the case may be, cash, shares of our common stock or a combination of cash and shares of our common stock, at our election. Because we have the intent and ability to deliver shares of our common stock upon conversion, the 2019 Notes remain classified as long-term debt. Subject to the occurrence of certain circumstances, on or after August 15, 2016 , we may redeem for cash all or a portion of the 2019 Notes. The redemption price will equal 100% of the principal amount of the 2019 Notes to be redeemed plus accrued and unpaid interest, if any, to, but excluding, the redemption date. The following is a summary of the interest expense for the 2019 Notes (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2016 2015 2016 2015 Stated coupon interest $ 3,054 $ 3,055 $ 6,109 $ 6,110 Amortization of debt discount and debt issuance costs 5,315 4,833 10,506 9,554 Total interest expense $ 8,369 $ 7,888 $ 16,615 $ 15,664 The balance of unamortized fees and costs was $2.2 million and $2.6 million as of June 30, 2016 and December 31, 2015 , respectively, which is recorded as a reduction of the carrying amount of the 2019 Notes on the accompanying Condensed Consolidated Balance Sheets. The debt discount and debt issuance costs will be amortized as interest expense through August 2019. Secured Convertible Notes due 2018 As of June 30, 2016 and December 31, 2015 , the outstanding principal balance on the Deerfield Notes was $107.7 million and $103.8 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 the interest expense for the Deerfield Notes (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2016 2015 2016 2015 Stated coupon interest paid in cash $ 1,972 $ 1,496 $ 3,908 $ 2,975 Amortization of debt discount, debt issuance costs and accrual of interest paid in kind 2,085 2,373 4,114 5,320 Total interest expense $ 4,057 $ 3,869 $ 8,022 $ 8,295 The balance of unamortized fees and costs was $0.6 million and $0.7 million as of June 30, 2016 and December 31, 2015 , respectively, which is recorded as a reduction of the carrying amount of the Deerfield Notes on the accompanying Condensed Consolidated Balance Sheets. Effective March 4, 2015, upon notification of our election to 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 15.3% . We were required to make an additional mandatory prepayment on the Deerfield Notes in January 2015 and 2016 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 . We made no such mandatory prepayments due to the fact that we received no such revenues during the fiscal year ended December 31, 2014 and Deerfield’s election not to receive the mandatory prepayment in January 2016 related to development/commercialization revenue received during the year ended December 31, 2015. 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 January 2017 and January 2018. However, we will only be obligated to make any such annual mandatory prepayment if the note holders provide notice to us of their election to receive the prepayment. Pursuant to this requirement, we may be required make a mandatory prepayment of $27.5 million in January 2017 as a result of the upfront payment of $200.0 million received in March 2016 in consideration for the exclusive license and other rights contained in the collaboration and license agreement with Ipsen. That portion of the Deerfield Notes is included in current liabilities. 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. |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2016 | |
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 June 30, 2016 and December 31, 2015 . We did not have any financial liabilities that were measured and recorded on a recurring basis or Level 3 investments as of June 30, 2016 . The amounts presented exclude cash, but include investments classified as cash equivalents (in thousands): June 30, 2016 Level 1 Level 2 Total Money market funds $ 27,517 $ — $ 27,517 Commercial paper — 163,062 163,062 Corporate bonds — 120,529 120,529 U.S. Treasury and government sponsored enterprises — 63,683 63,683 Total financial assets $ 27,517 $ 347,274 $ 374,791 December 31, 2015 Level 1 Level 2 Total Money market funds $ 72,000 $ — $ 72,000 Commercial paper — 78,155 78,155 Corporate bonds — 72,091 72,091 U.S. Treasury and government sponsored enterprises — 28,423 28,423 Marketable equity securities 18 — 18 Total financial assets $ 72,018 $ 178,669 $ 250,687 The estimated fair value of our financial instruments that are carried at amortized cost is as follows (in thousands) : June 30, 2016 December 31, 2015 Carrying Amount Fair Value Carrying Amount Fair Value 2019 Notes $ 209,214 $ 427,283 $ 198,708 $ 336,260 Deerfield Notes $ 106,841 $ 111,226 $ 102,727 $ 101,096 Term loan payable $ 80,000 $ 79,717 $ 80,000 $ 79,815 The carrying amounts of cash, trade and other receivables, accounts payable, accrued clinical trial liabilities, accrued compensation and benefits, accrued collaboration liability, 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: • 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. • We estimate the fair value of our other debt instruments, where possible, using the net present value of the payments. For the term loan, 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 June 30, 2016 , which is a Level 3 input. |
Stock-Based Compensation
Stock-Based Compensation | 6 Months Ended |
Jun. 30, 2016 | |
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 June 30, Six Months Ended June 30, 2016 2015 2016 2015 Research and development expense $ 1,165 $ 746 $ 6,729 $ 1,373 Selling, general and administrative expense 2,393 988 8,014 2,021 Total employee stock-based compensation expense $ 3,558 $ 1,734 $ 14,743 $ 3,394 We use the Black-Scholes Merton option pricing model to value our stock options. The weighted average grant-date fair value of our stock options and ESPP purchases was as follows: Three Months Ended June 30, Six Months Ended June 30, 2016 2015 2016 2015 Stock options $ 3.17 $ 2.41 $ 2.67 $ 1.28 ESPP $ 1.60 $ 1.11 $ 1.79 $ 0.85 The fair value of employee stock option awards and ESPP purchases was estimated using the following assumptions: Stock Options Three Months Ended June 30, Six Months Ended June 30, 2016 2015 2016 2015 Risk-free interest rate 0.90 % 1.27 % 1.10 % 1.20 % Dividend yield — % — % — % — % Volatility 67 % 106 % 76 % 89 % Expected life 4.4 years 4.5 years 4.4 years 4.5 years Employee Stock Purchase Plan Three Months Ended June 30, Six Months Ended June 30, 2016 2015 2016 2015 Risk-free interest rate 0.39 % 0.07 % 0.42 % 0.10 % Dividend yield — % — % — % — % Volatility 65 % 104 % 69 % 99 % Expected life 6 months 6 months 6 months 6 months 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. A summary of all stock option activity for the six months ended June 30, 2016 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, 2015 27,425,854 $ 4.22 Granted 2,727,350 $ 4.63 Exercised (1,321,802 ) $ 1.89 Forfeited (197,038 ) $ 4.32 Expired (80,516 ) $ 10.89 Options outstanding at June 30, 2016 28,553,848 $ 4.35 4.68 years $ 112,155 Exercisable at June 30, 2016 20,872,344 $ 4.02 4.13 years $ 89,643 As of June 30, 2016 , a total of 2,790,649 shares were available for grant under our stock option plans. As of June 30, 2016 , we had $17.7 million of unrecognized compensation expense related to employee stock options that is expected to be recognized over a weighted-average period of 3.02 years . On March 7, 2016, as a result of the FDA acceptance of our New Drug Application “NDA” submission and on April 28, 2016, as a result of the FDA’s approval of our NDA submission, the Compensation Committee of the Board of Directors of Exelixis convened to determine we had met certain performance objectives related to performance-based stock options granted to employees in 2014 and 2015. As a result of these determinations, 5,870,303 performance-based stock options vested during the six months ended June 30, 2016 and we recorded an additional $4.1 million in stock-based compensation expense during the period related to those options. During 2015, we recorded $3.3 million in employee stock-based compensation expense related to those options. A summary of all restricted stock unit (“RSU”) activity for the six months ended June 30, 2016 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, 2015 1,002,188 $ 5.16 Awarded 2,126,191 $ 4.32 Vested and released (1,215,756 ) $ 4.22 Forfeited (10,059 ) $ 5.64 Awards outstanding at June 30, 2016 1,902,564 $ 4.82 1.71 years $ 15,544 As of June 30, 2016 , we had $3.7 million of unrecognized compensation expense related to employee RSUs that is expected to be recognized over a weighted-average period of 2.88 years . During the six months ended June 30, 2016 , we made a bonus payment to our employees in the form of 1,072,833 shares of fully-vested restricted stock units which have a grant date fair value of $4.5 million . |
Net Loss Per Share
Net Loss Per Share | 6 Months Ended |
Jun. 30, 2016 | |
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 June 30, Six Months Ended June 30, 2016 2015 2016 2015 Numerator: Net loss $ (37,015 ) $ (43,362 ) $ (98,362 ) $ (78,532 ) Denominator: Shares used in computing basic and diluted net loss per share 229,310 196,201 228,860 196,052 Net loss per share, basic and diluted $ (0.16 ) $ (0.22 ) $ (0.43 ) $ (0.40 ) The following table sets forth 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): June 30 2016 2015 Convertible Senior Subordinated Notes due 2019 54,118 54,118 Secured Convertible Notes due 2018 33,890 33,890 Outstanding stock options, unvested RSUs and ESPP contributions 30,637 29,049 Warrants 1,000 1,000 Total potentially dilutive shares 119,645 118,057 The 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 | 6 Months Ended |
Jun. 30, 2016 | |
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 June 30, 2016 , 43% , 17% and 10% of our trade receivables are with Diplomat Specialty Pharmacy, Caremark L.L.C. and affiliates of McKesson Corporation, respectively. All 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. The following table shows the percentage of revenues earned in the United States and European Union. Three Months Ended June 30, Six Months Ended June 30, 2016 2015 2016 2015 Percentage of revenues earned in the United States 89 % 88 % 89 % 87 % Percentage of revenues earned in the European Union 11 % 12 % 11 % 13 % The following table sets forth the percentage of revenues recognized by customer that represent 10% or more of total revenues: Three Months Ended June 30, Six Months Ended June 30, 2016 2015 2016 2015 Product sales: Diplomat Specialty Pharmacy 52 % 88 % 53 % 87 % Sobi 1 % 12 % 2 % 13 % Collaboration agreements: Merck — % — % 10 % — % Ipsen 10 % — % 9 % — % |
Organization and Summary of S17
Organization and Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2016 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization | Organization Exelixis, Inc. (“Exelixis,” “we,” “our” or “us”) is a biopharmaceutical company committed to the discovery, development and commercialization of new medicines that will improve care and outcomes for people with cancer. Since its founding in 1994, three products discovered at Exelixis have progressed through clinical development, received regulatory approval, and entered the commercial marketplace. This portfolio includes two products derived from cabozantinib, an inhibitor of multiple tyrosine kinases including MET, AXL and VEGF receptors. They are CABOMETYX™ tablets for the treatment of advanced kidney cancer in the United States and COMETRIQ ® capsules for the treatment of certain forms of thyroid cancer in both the United States and European Union. The third product is COTELLIC ® , a product derived from cobimetinib, a selective inhibitor of MEK, marketed under a collaboration with Roche and Genentech (a member of the Roche Group) that has been approved in combination with ZELBORAF ® (vemurafenib) to treat advanced melanoma in several major territories, including the United States and European Union. |
Basis of Consolidation | Basis of Consolidation The condensed 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 condensed 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 periods presented have been included. |
Fiscal Period | We adopted a 52- or 53-week fiscal year that generally ends on the Friday closest to December 31 st . Fiscal year 2016 will end on December 30, 2016, and fiscal year 2015, ended on January 1, 2016. For convenience, references in this report as of and for the fiscal periods ended September 30, 2016, July 1, 2016 and July 3, 2015, and as of and for the fiscal years ended December 30, 2016 and January 1, 2016, are indicated as being as of and for the periods ended September 30, 2016, June 30, 2016, June 30, 2015, and the years ended December 31, 2016, and December 31, 2015, 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 revenue recognition, including for deductions from revenues (such as rebates, chargebacks, sales returns and sales allowances) and the period of performance, identification of deliverables and evaluation of milestones with respect to our collaborations , recoverability of inventory, certain accrued liabilities including clinical trial and collaboration liability accruals, and share-based compensation. 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 product sales and from license fees, milestones, contingent payments and royalties earned on research, collaboration and license arrangements. 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, 2015 for a description of our revenue recognition policies for product sales discounts and allowances, license and contract revenues under our collaboration agreement with Genentech and our Patient Assistance Program. 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 a specialty pharmacy or distributor. For product sales in Europe, this generally occurs when our European distribution partner, Swedish Orphan Biovitrum (“Sobi”), has accepted the product. In the United States, we sell our products, CABOMETYX and COMETRIQ, to specialty pharmacies and distributors that benefit from customer incentives and have 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 a single specialty pharmacy, therefore we recognized revenue when the specialty pharmacy provided the product to a patient based on the fulfillment of a prescription, which is frequently referred to as the “sell-through” revenue recognition model. In January 2015, we established that we had sufficient historical experience and data to reasonably estimate expected future returns of COMETRIQ 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 the 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 that had previously been deferred under the “sell-through” revenue recognition model, resulting in the additional recognition of gross product revenues of $2.6 million for the six months ended June 30, 2015 ; there were no such additional amounts recorded during the comparable period in 2016 . In determining discounts and allowances for the initial launch and sale of CABOMETYX, in addition to using payer data received from the specialty pharmacies and distributors that sell CABOMETYX and historical data for COMETRIQ, we also utilized claims data from third party sources for competitor products for the treatment of advanced RCC. Based in part on the availability of this third party data, we made the determination that we had sufficient experience and data to reasonably estimate expected future returns and the discounts and allowances due to payers at the time of shipment to the specialty pharmacy or distributor, and therefore record revenue for the product using the “sell-in” revenue recognition model. Net product revenues during the three and six months ended June 30, 2016 was impacted by the build of channel inventory related to the initial launch period for CABOMETYX. We also utilize the “sell-in” revenue recognition model for sales to Sobi for all periods presented. Once Sobi has accepted the product, the product is generally no longer subject to return; therefore, we record revenue at the time Sobi has accepted the product. As described further in “Note 2 - Research and Collaboration Agreements”, under the terms of our collaboration and license agreement with Ipsen for the commercialization and further development of cabozantinib, we provided Sobi with a notice of termination of our distribution and commercial agreement for COMETRIQ which will become effective during the fourth quarter of 2016. Pursuant to our commercialization agreement with Sobi, we expect to repurchase the remaining product on hand from Sobi at the termination of that agreement. As of June 30, 2016 , we recorded reserves for expected future returns totaling $0.7 million ; there were no such reserves recorded as of December 31, 2015 or June 30, 2015 . Royalty, License and Contract Revenues We enter into corporate collaboration and license agreements under which we may obtain upfront license fees, research funding, and contingent, milestone and royalty payments. Our deliverables under these arrangements may include intellectual property rights, distribution rights, delivery of manufactured product, participation on joint steering committees and/or research and development services. In order to account for the multiple-element arrangements, we identify the deliverables included within the arrangement and evaluate whether the delivered elements under these arrangements have value to our collaboration partner on a stand-alone basis and represent separate units of accounting. Analyzing the arrangement to identify deliverables requires the use of judgment, and each deliverable may be an obligation to deliver future goods or services, a right or license to use an asset, or another performance obligation. If we determine that multiple deliverables exist, the consideration is allocated to one or more units of accounting based upon the best estimate of the selling price of each deliverable. The selling price used for each deliverable will be based on vendor-specific objective evidence, if available, third-party evidence if vendor-specific objective evidence is not available, or estimated selling price if neither vendor-specific or third-party evidence is available. A delivered item or items that do not qualify as a separate unit of accounting within the arrangement shall be combined with the other applicable undelivered items within the arrangement. The allocation of arrangement consideration and the recognition of revenue then shall be determined for those combined deliverables as a single unit of accounting. For a combined unit of accounting, non-refundable upfront fees are recognized in a manner consistent with the final deliverable, which has generally been ratably over the period of continued involvement. Amounts received in advance of performance are recorded as deferred revenue. Upfront fees are classified as license revenues in our consolidated statements of operations. We consider sales-based contingent payments to be royalty revenue which is generally recognized at the date the contingency is achieved. Royalties are recorded based on sales amounts reported to us for the preceding quarter. For certain contingent payments under collaboration and license arrangements, we recognize revenue using the milestone method. Under the milestone method a payment that is contingent upon the achievement of a substantive milestone is recognized in its entirety in the period in which the milestone is achieved. A milestone is an event: (i) that can be achieved based in whole or in part on either our performance or on the occurrence of a specific outcome resulting from our performance, (ii) for which there is substantive uncertainty at the date the arrangement is entered into that the event will be achieved and (iii) that would result in additional payments being due to us. The determination that a milestone is substantive requires estimation and judgment and is made at the inception of the arrangement. Milestones are considered substantive when the consideration earned from the achievement of the milestone is: (i) commensurate with either our performance to achieve the milestone or the enhancement of value of the item delivered as a result of a specific outcome resulting from our performance to achieve the milestone, (ii) relates solely to past performance and (iii) reasonable relative to all deliverables and payment terms in the arrangement. In making the determination as to whether a milestone is substantive or not, we consider all facts and circumstances relevant to the arrangement, including factors such as the scientific, regulatory, commercial and other risks that must be overcome to achieve the respective milestone, the level of effort and investment required to achieve the respective milestone and whether any portion of the milestone consideration is related to future performance or deliverables. |
Recently Issued Accounting Pronouncements | Recently Adopted Accounting Pronouncements In April 2015, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update No. 2015-05, Customer’s Accounting for Fees Paid in a Cloud Computing Arrangement , (“ASU 2015-05”) . ASU 2015-05 provides guidance to customers about whether a cloud computing arrangement includes a software license. If a cloud computing arrangement includes a software license, then the customer should account for the software license element of the arrangement consistent with the acquisition of other software licenses. If a cloud computing arrangement does not include a software license, the customer should account for the arrangement as a service contract. ASU 2015-05 was effective for all interim and annual reporting periods beginning after December 15, 2015 and therefore we adopted ASU 2015-05 in the three months ended March 31, 2016 on a prospective basis. The adoption of ASU 2015-05 did not have a material impact on our Condensed Consolidated Statements of Operations during the period of adoption and is not expected to have a material effect on our Consolidated Financial Statements in future periods. Recently Issued Accounting Pronouncements In March 2016, the FASB issued Accounting Standards Update No. 2016-09, Improvements to Employee Share-Based Payment Accounting , (“ASU 2016-09”) . ASU 2016-09 is aimed at the simplification of several aspects of the accounting for employee share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities, and classification on the statement of cash flows. ASU 2016-09 is effective for all interim and annual reporting periods beginning after December 15, 2016. Early adoption is permitted. We are currently evaluating the impact that the adoption of ASU 2016-09 will have on our consolidated financial statements and related disclosures. |
Restructurings (Tables)
Restructurings (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Restructuring Charges [Abstract] | |
Summary Of Components Of Restructuring Liability | The changes of these liabilities during the six months ended June 30, 2016 , which related primarily to facilities, are summarized in the following table (in thousands): 2010 Restructurings 2014 Restructuring Total Restructuring liability as of December 31, 2015 $ 4,087 $ 503 $ 4,590 Restructuring charge 1,106 9 1,115 Proceeds from sale of assets — 34 34 Cash payments, net (1,694 ) (347 ) (2,041 ) Other items — (34 ) (34 ) Restructuring liability as of June 30, 2016 $ 3,499 $ 165 $ 3,664 |
Cash and Investments (Tables)
Cash and Investments (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
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 June 30, 2016 and December 31, 2015 (in thousands): June 30, 2016 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Cash and cash equivalents $ 129,827 $ — $ — $ 129,827 Short-term investments 198,148 150 (6 ) 198,292 Long-term investments 51,636 96 (5 ) 51,727 Long-term restricted cash and investments 4,150 — — 4,150 Total cash and investments $ 383,761 $ 246 $ (11 ) $ 383,996 December 31, 2015 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Cash and cash equivalents $ 141,634 $ — $ — $ 141,634 Short-term investments 25,484 5 (63 ) 25,426 Long-term investments 83,665 2 (67 ) 83,600 Long-term restricted cash and investments 2,650 — — 2,650 Total cash and investments $ 253,433 $ 7 $ (130 ) $ 253,310 |
Summary of Cash and Investments by Security Type | The amounts presented exclude cash, but include investments classified as cash equivalents (in thousands): June 30, 2016 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Money market funds $ 27,517 $ — $ — $ 27,517 Commercial paper 163,062 — — 163,062 Corporate bonds 120,389 150 (11 ) 120,528 U.S. Treasury and government sponsored enterprises 63,587 96 — 63,683 Total investments $ 374,555 $ 246 $ (11 ) $ 374,790 December 31, 2015 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Money market funds $ 72,000 $ — $ — $ 72,000 Commercial paper 78,155 — — 78,155 Corporate bonds 72,205 4 (118 ) 72,091 U.S. Treasury and government sponsored enterprises 28,434 1 (12 ) 28,423 Marketable equity security 16 2 — 18 Total investments $ 250,810 $ 7 $ (130 ) $ 250,687 |
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 June 30, 2016 (in thousands): Mature within One Year After One Year through Two Years Fair Value Money market funds $ 27,517 $ — $ 27,517 Commercial paper 163,062 — 163,062 Corporate bonds 72,806 47,722 120,528 U.S. Treasury and government sponsored enterprises 59,678 4,005 63,683 Total investments $ 323,063 $ 51,727 $ 374,790 |
Inventory (Tables)
Inventory (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory | Inventory consists of the following (in thousands): June 30, December 31, Raw materials $ 973 $ 1,037 Work in process 2,277 2,251 Finished goods 714 583 Total 3,964 3,871 Less: non-current portion included in Other assets (1,156 ) (1,255 ) Inventory $ 2,808 $ 2,616 |
Debt (Tables)
Debt (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Debt Disclosure [Abstract] | |
Schedule Of Debt | The amortized carrying amount of our debt consists of the following (in thousands): June 30, December 31, Convertible Senior Subordinated Notes due 2019 $ 209,214 $ 198,708 Secured Convertible Notes due 2018 106,841 102,727 Term loan payable 80,000 80,000 Total debt 396,055 381,435 Less: current portion (107,500 ) — Long-term debt $ 288,555 $ 381,435 |
Summary Of The Liability Component Notes | The following is a summary of the liability component of the 2019 Notes (in thousands): June 30, December 31, Net carrying amount of the liability component $ 209,214 $ 198,708 Unamortized discount of the liability component 78,286 88,792 Face amount of the 2019 Notes $ 287,500 $ 287,500 The 2019 Notes are convertible at the note-holder’s option during the quarter ending September 30, 2016 as one of the conversion criteria has been met. Specifically, the price of our common stock exceeded $6.91 for 20 of the last 30 consecutive trading days during the quarter ended June 30, 2016 . The continuance of such conversion rights subsequent to September 30, 2016 is subject to the occurrence of certain circumstances. The 2019 Notes are convertible at a conversion rate of 188.2353 shares of common stock per $1,000 principal amount of the 2019 Notes, subject to adjustment in connection with certain events. Upon conversion, we have the option to pay or deliver, as the case may be, cash, shares of our common stock or a combination of cash and shares of our common stock, at our election. Because we have the intent and ability to deliver shares of our common stock upon conversion, the 2019 Notes remain classified as long-term debt. Subject to the occurrence of certain circumstances, on or after August 15, 2016 , we may redeem for cash all or a portion of the 2019 Notes. The redemption price will equal 100% of the principal amount of the 2019 Notes to be redeemed plus accrued and unpaid interest, if any, to, but excluding, the redemption date. The following is a summary of the interest expense for the 2019 Notes (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2016 2015 2016 2015 Stated coupon interest $ 3,054 $ 3,055 $ 6,109 $ 6,110 Amortization of debt discount and debt issuance costs 5,315 4,833 10,506 9,554 Total interest expense $ 8,369 $ 7,888 $ 16,615 $ 15,664 The following is a summary of the interest expense for the Deerfield Notes (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2016 2015 2016 2015 Stated coupon interest paid in cash $ 1,972 $ 1,496 $ 3,908 $ 2,975 Amortization of debt discount, debt issuance costs and accrual of interest paid in kind 2,085 2,373 4,114 5,320 Total interest expense $ 4,057 $ 3,869 $ 8,022 $ 8,295 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
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): June 30, 2016 Level 1 Level 2 Total Money market funds $ 27,517 $ — $ 27,517 Commercial paper — 163,062 163,062 Corporate bonds — 120,529 120,529 U.S. Treasury and government sponsored enterprises — 63,683 63,683 Total financial assets $ 27,517 $ 347,274 $ 374,791 December 31, 2015 Level 1 Level 2 Total Money market funds $ 72,000 $ — $ 72,000 Commercial paper — 78,155 78,155 Corporate bonds — 72,091 72,091 U.S. Treasury and government sponsored enterprises — 28,423 28,423 Marketable equity securities 18 — 18 Total financial assets $ 72,018 $ 178,669 $ 250,687 |
Schedule Of Estimated Fair Value Of Outstanding Debt | The estimated fair value of our financial instruments that are carried at amortized cost is as follows (in thousands) : June 30, 2016 December 31, 2015 Carrying Amount Fair Value Carrying Amount Fair Value 2019 Notes $ 209,214 $ 427,283 $ 198,708 $ 336,260 Deerfield Notes $ 106,841 $ 111,226 $ 102,727 $ 101,096 Term loan payable $ 80,000 $ 79,717 $ 80,000 $ 79,815 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
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 June 30, Six Months Ended June 30, 2016 2015 2016 2015 Research and development expense $ 1,165 $ 746 $ 6,729 $ 1,373 Selling, general and administrative expense 2,393 988 8,014 2,021 Total employee stock-based compensation expense $ 3,558 $ 1,734 $ 14,743 $ 3,394 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value | We use the Black-Scholes Merton option pricing model to value our stock options. The weighted average grant-date fair value of our stock options and ESPP purchases was as follows: Three Months Ended June 30, Six Months Ended June 30, 2016 2015 2016 2015 Stock options $ 3.17 $ 2.41 $ 2.67 $ 1.28 ESPP $ 1.60 $ 1.11 $ 1.79 $ 0.85 |
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: Stock Options Three Months Ended June 30, Six Months Ended June 30, 2016 2015 2016 2015 Risk-free interest rate 0.90 % 1.27 % 1.10 % 1.20 % Dividend yield — % — % — % — % Volatility 67 % 106 % 76 % 89 % Expected life 4.4 years 4.5 years 4.4 years 4.5 years Employee Stock Purchase Plan Three Months Ended June 30, Six Months Ended June 30, 2016 2015 2016 2015 Risk-free interest rate 0.39 % 0.07 % 0.42 % 0.10 % Dividend yield — % — % — % — % Volatility 65 % 104 % 69 % 99 % 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 six months ended June 30, 2016 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, 2015 27,425,854 $ 4.22 Granted 2,727,350 $ 4.63 Exercised (1,321,802 ) $ 1.89 Forfeited (197,038 ) $ 4.32 Expired (80,516 ) $ 10.89 Options outstanding at June 30, 2016 28,553,848 $ 4.35 4.68 years $ 112,155 Exercisable at June 30, 2016 20,872,344 $ 4.02 4.13 years $ 89,643 |
Summary Of All RSU Activity | A summary of all restricted stock unit (“RSU”) activity for the six months ended June 30, 2016 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, 2015 1,002,188 $ 5.16 Awarded 2,126,191 $ 4.32 Vested and released (1,215,756 ) $ 4.22 Forfeited (10,059 ) $ 5.64 Awards outstanding at June 30, 2016 1,902,564 $ 4.82 1.71 years $ 15,544 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
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 June 30, Six Months Ended June 30, 2016 2015 2016 2015 Numerator: Net loss $ (37,015 ) $ (43,362 ) $ (98,362 ) $ (78,532 ) Denominator: Shares used in computing basic and diluted net loss per share 229,310 196,201 228,860 196,052 Net loss per share, basic and diluted $ (0.16 ) $ (0.22 ) $ (0.43 ) $ (0.40 ) |
Schedule Of Potential Shares Of Common Stock Not Included In Computation Of Diluted Net Loss Per Share | The following table sets forth 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): June 30 2016 2015 Convertible Senior Subordinated Notes due 2019 54,118 54,118 Secured Convertible Notes due 2018 33,890 33,890 Outstanding stock options, unvested RSUs and ESPP contributions 30,637 29,049 Warrants 1,000 1,000 Total potentially dilutive shares 119,645 118,057 |
Concentrations of Credit Risk (
Concentrations of Credit Risk (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Risks and Uncertainties [Abstract] | |
Schedules of concentration risk | The following table shows the percentage of revenues earned in the United States and European Union. Three Months Ended June 30, Six Months Ended June 30, 2016 2015 2016 2015 Percentage of revenues earned in the United States 89 % 88 % 89 % 87 % Percentage of revenues earned in the European Union 11 % 12 % 11 % 13 % The following table sets forth the percentage of revenues recognized by customer that represent 10% or more of total revenues: Three Months Ended June 30, Six Months Ended June 30, 2016 2015 2016 2015 Product sales: Diplomat Specialty Pharmacy 52 % 88 % 53 % 87 % Sobi 1 % 12 % 2 % 13 % Collaboration agreements: Merck — % — % 10 % — % Ipsen 10 % — % 9 % — % |
Organization and Summary of S26
Organization and Summary of Significant Accounting Policies (Details) $ in Thousands | Apr. 25, 2016 | Jun. 30, 2016USD ($) | Jun. 30, 2015USD ($) | Jun. 30, 2016USD ($)segment | Jun. 30, 2015USD ($) | Jun. 30, 2016USD ($) | Dec. 31, 2015USD ($) | |
Operations [Line Items] | ||||||||
Number of operating segments | segment | 1 | |||||||
Net income (loss) | $ (37,015) | $ (43,362) | $ (98,362) | $ (78,532) | ||||
Retained earnings (accumulated deficit) | (2,035,403) | (2,035,403) | $ (2,035,403) | $ (1,937,041) | [1] | |||
Net product revenues | 31,618 | 7,992 | 40,717 | 17,380 | 115,000 | |||
Shipping period for newly approved product, upon initial approval | 3 days | |||||||
Cash and investments | 383,996 | 383,996 | 383,996 | 253,310 | ||||
Cash and investments available for operations | 298,200 | 298,200 | 298,200 | |||||
Compensating balance investments | 81,600 | 81,600 | 81,600 | |||||
Long-term restricted cash and investments | 4,150 | 4,150 | 4,150 | 2,650 | [1] | |||
Reserve for returns and repurchase of unsold product | 700 | 0 | 700 | 0 | $ 700 | $ 0 | ||
“Sell-In” Revenue Recognition Model [Member] | ||||||||
Operations [Line Items] | ||||||||
Net product revenues | $ 0 | $ 0 | $ 0 | $ 2,600 | ||||
[1] | The condensed consolidated balance sheet as of December 31, 2015 has been derived from the audited financial statements as of that date. |
Research and Collaboration Ag27
Research and Collaboration Agreements (Ipsen Collaboration) (Details) | Feb. 29, 2016USD ($)paymentcountry | Mar. 31, 2016USD ($) | Jun. 30, 2016USD ($) | Jun. 30, 2016USD ($) | Dec. 31, 2015USD ($) | Jun. 30, 2015USD ($) | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Current portion of deferred revenue | $ 14,631,000 | $ 14,631,000 | $ 0 | [1] | |||
Long-term portion of deferred revenue | 180,838,000 | 180,838,000 | 0 | [1] | |||
Reserve for returns and repurchase of unsold product | 700,000 | 700,000 | $ 0 | $ 0 | |||
Ipsen [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Upfront and milestone payments | $ 200,000,000 | ||||||
Eligible payment from collaboration for development and regulatory milestone achievement Under Collaborations Agreement | $ 252,500,000 | ||||||
Maximum amount eligible for commercial milestones under collaborations agreement | $ 525,000,000 | ||||||
Research and development arrangement performed for others, reimbursement for costs incurred (as a percent) | 35.00% | ||||||
License and contract revenue | 3,600,000 | 4,800,000 | |||||
Current portion of deferred revenue | 14,400,000 | 14,400,000 | |||||
Long-term portion of deferred revenue | 180,800,000 | 180,800,000 | |||||
RCC [Member] | Ipsen [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Eligible payment from collaboration for development and regulatory milestone achievement Under Collaborations Agreement | $ 60,000,000 | ||||||
HCC Filing [Member] | Ipsen [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Eligible payment from collaboration for development and regulatory milestone achievement Under Collaborations Agreement | 10,000,000 | ||||||
HCC Acceptance [Member] | Ipsen [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Eligible payment from collaboration for development and regulatory milestone achievement Under Collaborations Agreement | $ 40,000,000 | ||||||
EU Country Launch [Member] | Ipsen [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Number of payments to be received upon milestone achievement | payment | 2 | ||||||
Maximum amount eligible for commercial milestones under collaborations agreement | $ 10,000,000 | ||||||
Number of countries in which entity launches product | country | 2 | ||||||
Initial [Member] | Ipsen [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Percent of royalty on net sale | 2.00% | ||||||
Royalty tier | $ 50,000,000 | ||||||
Second [Member] | Ipsen [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Percent of royalty on net sale | 12.00% | ||||||
Royalty tier | $ 100,000,000 | ||||||
Initial and second [Member] | Ipsen [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Royalty tier | $ 150,000,000 | ||||||
Minimum [Member] | Ipsen [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Percent of royalty on net sale | 22.00% | ||||||
Maximum [Member] | Ipsen [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Percent of royalty on net sale | 26.00% | ||||||
Swedish Orphan Biovitrum [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Termination fee | 2,700,000 | 2,700,000 | |||||
Reserve for returns and repurchase of unsold product | $ 500,000 | $ 500,000 | |||||
[1] | The condensed consolidated balance sheet as of December 31, 2015 has been derived from the audited financial statements as of that date. |
Research and Collaboration Ag28
Research and Collaboration Agreements (Genetech and Other Collaborations) (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||
Nov. 30, 2015 | Jan. 31, 2007 | Dec. 31, 2006 | Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Genentech [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Upfront and milestone payments | $ 15,000,000 | $ 25,000,000 | |||||
Profit sharing agreement, percent of total sales force | 25.00% | ||||||
License and contract revenue | $ 1,000,000 | $ 0 | $ 1,200,000 | $ 0 | |||
Merck [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Development milestone payments received under collaborative arrangement | 0 | 0 | $ 5,000,000 | 0 | |||
Profit Sharing Tier One [Member] | Genentech [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Profit sharing agreement (as a percent of profits) | 50.00% | ||||||
Profit sharing agreement, profit threshold | $ 200,000,000 | ||||||
Profit Sharing Tier Two [Member] | Genentech [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Profit sharing agreement (as a percent of profits) | 30.00% | ||||||
Profit sharing agreement, profit threshold | $ 400,000,000 | ||||||
Selling, general and administrative expense [Member] | Genentech [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Collaborative arrangement, income (loss) from agreement | $ (4,600,000) | $ (4,000,000) | $ (11,900,000) | $ (7,000,000) |
Restructurings (Narrative) (Det
Restructurings (Narrative) (Details) $ in Thousands | 3 Months Ended | 6 Months Ended | 39 Months Ended | |||
Jun. 30, 2016USD ($) | Jun. 30, 2015USD ($) | Jun. 30, 2016USD ($) | Jun. 30, 2015USD ($) | May 31, 2013restructuring | Dec. 31, 2015USD ($) | |
Restructuring Cost and Reserve [Line Items] | ||||||
Restructuring charge | $ 1,021 | $ 1,291 | $ 1,115 | $ 860 | ||
Restructuring reserve | 3,664 | 3,664 | $ 4,590 | |||
Expected additional restructuring costs to be incurred | 100 | 100 | ||||
Facility Closing [Member] | ||||||
Restructuring Cost and Reserve [Line Items] | ||||||
Restructuring charge | 1,000 | 1,800 | ||||
Recoveries related to sale of buildings | $ (900) | |||||
2010 Restructurings [Member] | ||||||
Restructuring Cost and Reserve [Line Items] | ||||||
Number of restructurings implemented | restructuring | 5 | |||||
Restructuring charge | 1,106 | |||||
Restructuring reserve | $ 3,499 | $ 3,499 | $ 4,087 |
Restructurings (Summary of Comp
Restructurings (Summary of Components of Restructuring Liability) (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Restructuring Reserve [Roll Forward] | ||||
Restructuring liability, beginning balance | $ 4,590 | |||
Restructuring charge | $ 1,021 | $ 1,291 | 1,115 | $ 860 |
Proceeds from sale of assets | 34 | |||
Cash payments, net | (2,041) | |||
Other items | (34) | |||
Restructuring liability, ending balance | 3,664 | 3,664 | ||
2010 Restructurings [Member] | ||||
Restructuring Reserve [Roll Forward] | ||||
Restructuring liability, beginning balance | 4,087 | |||
Restructuring charge | 1,106 | |||
Proceeds from sale of assets | 0 | |||
Cash payments, net | (1,694) | |||
Other items | 0 | |||
Restructuring liability, ending balance | 3,499 | 3,499 | ||
2014 Restructuring [Member] | ||||
Restructuring Reserve [Roll Forward] | ||||
Restructuring liability, beginning balance | 503 | |||
Restructuring charge | 9 | |||
Proceeds from sale of assets | 34 | |||
Cash payments, net | (347) | |||
Other items | (34) | |||
Restructuring liability, ending balance | $ 165 | $ 165 |
Cash and Investments (Details)
Cash and Investments (Details) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016USD ($)investment | Jun. 30, 2016USD ($)accountinvestmentaffiliate | Jun. 30, 2015USD ($) | Dec. 31, 2015USD ($) | |
Schedule of Available-for-sale Securities [Line Items] | ||||
Amortized Cost | $ 383,761,000 | $ 383,761,000 | $ 253,433,000 | |
Gross Unrealized Gains | 246,000 | 246,000 | 7,000 | |
Gross Unrealized Losses | (11,000) | (11,000) | (130,000) | |
Fair Value | 383,996,000 | $ 383,996,000 | 253,310,000 | |
Debt collateral, number of required investment accounts | account | 1 | |||
Debt collateral, number of affiliate banks | affiliate | 1 | |||
Payments to acquired certificates on deposit | 1,500,000 | |||
Amortized Cost | 374,555,000 | $ 374,555,000 | 250,810,000 | |
Gross Unrealized Gains | 246,000 | 246,000 | 7,000 | |
Gross Unrealized Losses | (11,000) | (11,000) | (130,000) | |
Fair Value | $ 374,790,000 | 374,790,000 | 250,687,000 | |
Other than temporary impairment losses, available-for-sale securities | $ 0 | $ 0 | ||
Number of investments in an unrealized loss position, less than 1 year | investment | 6 | 6 | ||
Unrealized loss position, less than 1 year | $ (11,000) | $ (11,000) | ||
Unrealized loss position, less than 1 year, fair value | 13,100,000 | 13,100,000 | ||
Mature within One Year | 323,063,000 | 323,063,000 | ||
After One Year through Two Years | 51,727,000 | 51,727,000 | ||
Fair Value | 374,790,000 | 374,790,000 | 250,687,000 | |
Money market funds [Member] | ||||
Schedule of Available-for-sale Securities [Line Items] | ||||
Amortized Cost | 27,517,000 | 27,517,000 | 72,000,000 | |
Gross Unrealized Gains | 0 | 0 | 0 | |
Gross Unrealized Losses | 0 | 0 | 0 | |
Fair Value | 27,517,000 | 27,517,000 | 72,000,000 | |
Mature within One Year | 27,517,000 | 27,517,000 | ||
After One Year through Two Years | 0 | 0 | ||
Fair Value | 27,517,000 | 27,517,000 | 72,000,000 | |
Commercial paper [Member] | ||||
Schedule of Available-for-sale Securities [Line Items] | ||||
Amortized Cost | 163,062,000 | 163,062,000 | 78,155,000 | |
Gross Unrealized Gains | 0 | 0 | 0 | |
Gross Unrealized Losses | 0 | 0 | 0 | |
Fair Value | 163,062,000 | 163,062,000 | 78,155,000 | |
Mature within One Year | 163,062,000 | 163,062,000 | ||
After One Year through Two Years | 0 | 0 | ||
Fair Value | 163,062,000 | 163,062,000 | 78,155,000 | |
Corporate bonds [Member] | ||||
Schedule of Available-for-sale Securities [Line Items] | ||||
Amortized Cost | 120,389,000 | 120,389,000 | 72,205,000 | |
Gross Unrealized Gains | 150,000 | 150,000 | 4,000 | |
Gross Unrealized Losses | (11,000) | (11,000) | (118,000) | |
Fair Value | 120,528,000 | 120,528,000 | 72,091,000 | |
Mature within One Year | 72,806,000 | 72,806,000 | ||
After One Year through Two Years | 47,722,000 | 47,722,000 | ||
Fair Value | 120,528,000 | 120,528,000 | 72,091,000 | |
U.S. Treasury and government sponsored enterprises [Member] | ||||
Schedule of Available-for-sale Securities [Line Items] | ||||
Amortized Cost | 63,587,000 | 63,587,000 | 28,434,000 | |
Gross Unrealized Gains | 96,000 | 96,000 | 1,000 | |
Gross Unrealized Losses | 0 | 0 | (12,000) | |
Fair Value | 63,683,000 | 63,683,000 | 28,423,000 | |
Mature within One Year | 59,678,000 | 59,678,000 | ||
After One Year through Two Years | 4,005,000 | 4,005,000 | ||
Fair Value | 63,683,000 | 63,683,000 | 28,423,000 | |
Marketable equity securities [Member] | ||||
Schedule of Available-for-sale Securities [Line Items] | ||||
Amortized Cost | 16,000 | |||
Gross Unrealized Gains | 2,000 | |||
Gross Unrealized Losses | 0 | |||
Fair Value | 18,000 | |||
Fair Value | 18,000 | |||
Silicon Valley Bank Loan And Security Agreement [Member] | ||||
Schedule of Available-for-sale Securities [Line Items] | ||||
Collateral balance | 81,600,000 | 81,600,000 | 81,600,000 | |
Cash and cash equivalents [Member] | ||||
Schedule of Available-for-sale Securities [Line Items] | ||||
Amortized Cost | 129,827,000 | 129,827,000 | 141,634,000 | |
Gross Unrealized Gains | 0 | 0 | 0 | |
Gross Unrealized Losses | 0 | 0 | 0 | |
Fair Value | 129,827,000 | 129,827,000 | 141,634,000 | |
Short-term investments [Member] | ||||
Schedule of Available-for-sale Securities [Line Items] | ||||
Amortized Cost | 198,148,000 | 198,148,000 | 25,484,000 | |
Gross Unrealized Gains | 150,000 | 150,000 | 5,000 | |
Gross Unrealized Losses | (6,000) | (6,000) | (63,000) | |
Fair Value | 198,292,000 | 198,292,000 | 25,426,000 | |
Long-term investments [Member] | ||||
Schedule of Available-for-sale Securities [Line Items] | ||||
Amortized Cost | 51,636,000 | 51,636,000 | 83,665,000 | |
Gross Unrealized Gains | 96,000 | 96,000 | 2,000 | |
Gross Unrealized Losses | (5,000) | (5,000) | (67,000) | |
Fair Value | 51,727,000 | 51,727,000 | 83,600,000 | |
Long-term restricted cash and investments [Member] | ||||
Schedule of Available-for-sale Securities [Line Items] | ||||
Amortized Cost | 4,150,000 | 4,150,000 | 2,650,000 | |
Gross Unrealized Gains | 0 | 0 | 0 | |
Gross Unrealized Losses | 0 | 0 | 0 | |
Fair Value | $ 4,150,000 | $ 4,150,000 | $ 2,650,000 |
Inventory (Details)
Inventory (Details) - USD ($) $ in Thousands | 6 Months Ended | |||
Jun. 30, 2016 | Jun. 30, 2015 | Dec. 31, 2015 | ||
Inventory Disclosure [Abstract] | ||||
Raw materials | $ 973 | $ 1,037 | ||
Work in process | 2,277 | 2,251 | ||
Finished goods | 714 | 583 | ||
Total | 3,964 | 3,871 | ||
Less: non-current portion included in Other assets | (1,156) | (1,255) | ||
Inventory | 2,808 | $ 2,616 | [1] | |
Inventory Write-down | $ 0 | $ 200 | ||
[1] | The condensed consolidated balance sheet as of December 31, 2015 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 | Jun. 30, 2016 | Dec. 31, 2015 |
Debt Instrument [Line Items] | ||
Total debt | $ 396,055 | $ 381,435 |
Less: current portion | (107,500) | 0 |
Long-term debt | 288,555 | 381,435 |
Senior Subordinated Notes [Member] | Convertible Senior Subordinated Notes due 2019 [Member] | ||
Debt Instrument [Line Items] | ||
Convertible Debt | 209,214 | 198,708 |
Secured Debt [Member] | Secured Convertible Notes due 2018 [Member] | ||
Debt Instrument [Line Items] | ||
Convertible Debt | 106,841 | 102,727 |
Term Loan [Member] | ||
Debt Instrument [Line Items] | ||
Term loan payable | $ 80,000 | $ 80,000 |
Debt (Convertible Notes) (Detai
Debt (Convertible Notes) (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | Dec. 31, 2015 | Aug. 31, 2012 | |
Debt Instrument [Line Items] | ||||||
Amortization of debt discount and debt issuance costs | $ 10,712,000 | $ 14,891,000 | ||||
Senior Subordinated Notes [Member] | Convertible Senior Subordinated Notes due 2019 [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Net carrying amount of the liability component | $ 209,214,000 | 209,214,000 | $ 198,708,000 | |||
Unamortized discount of the liability component | 78,286,000 | 78,286,000 | 88,792,000 | |||
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 | 6,109,000 | 6,110,000 | ||
Amortization of debt discount and debt issuance costs | 5,315,000 | 4,833,000 | 10,506,000 | 9,554,000 | ||
Total interest expense | 8,369,000 | 7,888,000 | 16,615,000 | 15,664,000 | ||
Secured Convertible Notes due 2018 [Member] | Deerfield Financing [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Net carrying amount of the liability component | 107,700,000 | 107,700,000 | $ 103,800,000 | |||
Stated coupon interest | 1,972,000 | 1,496,000 | 3,908,000 | 2,975,000 | ||
Amortization of debt discount and debt issuance costs | 2,085,000 | 2,373,000 | 4,114,000 | 5,320,000 | ||
Total interest expense | $ 4,057,000 | $ 3,869,000 | $ 8,022,000 | $ 8,295,000 |
Debt (Narrative) (Details)
Debt (Narrative) (Details) | Jul. 01, 2015USD ($) | Mar. 31, 2016USD ($) | Jan. 31, 2016 | Jan. 31, 2015USD ($) | Aug. 31, 2012USD ($) | Jun. 30, 2016USD ($)day$ / shares | Jun. 30, 2016USD ($) | Dec. 31, 2015USD ($) |
Ipsen [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Upfront and milestone payments | $ 200,000,000 | |||||||
Senior Subordinated Notes [Member] | Convertible Senior Subordinated Notes due 2019 [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt, interest rate (as a percent) | 4.25% | |||||||
Debt, principal amount | $ 287,500,000 | $ 287,500,000 | $ 287,500,000 | $ 287,500,000 | ||||
Convertible debt stock price trigger, in dollars per share | $ / shares | $ 6.91 | |||||||
Convertible debt threshold trading days | day | 20 | |||||||
Convertible debt threshold consecutive trading days | 30 days | |||||||
Convertible debt conversion ratio | 0.1882353 | |||||||
Conversion ratio, principal amount | $ 1,000 | |||||||
Redemption price (as a percent of principal) | 100.00% | |||||||
Balance of unamortized closing fees and expenses | $ 2,200,000 | $ 2,200,000 | 2,600,000 | |||||
Convertible debt | 209,214,000 | 209,214,000 | 198,708,000 | |||||
Secured Convertible Notes Due June 2018 [Member] | Deerfield Financing [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Balance of unamortized closing fees and expenses | 600,000 | 600,000 | 700,000 | |||||
Convertible debt | $ 107,700,000 | $ 107,700,000 | $ 103,800,000 | |||||
Debt instrument, interest rate, stated percentage after extension option election | 15.00% | 15.00% | ||||||
Annual interest | $ 6,000,000 | |||||||
Debt instrument, effective interest rate (as a percent) | 15.30% | 15.30% | ||||||
Percentage of revenue payable under collaborative arrangements | 15.00% | 15.00% | 15.00% | |||||
Maximum prepayment amount under collaborative arrangements | $ 27,500,000 | |||||||
Mandatory prepayment under collaborative arrangement | $ 27,500,000 | |||||||
Secured Convertible Notes Due June 2018 [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 2018 [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% |
Fair Value Measurements (Schedu
Fair Value Measurements (Schedule Of Fair Value Of Financial Assets Measured On A Recurring Basis) (Details) - USD ($) $ in Thousands | Jun. 30, 2016 | Dec. 31, 2015 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | $ 374,791 | $ 250,687 |
Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 27,517 | 72,018 |
Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 347,274 | 178,669 |
Money market funds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 27,517 | 72,000 |
Money market funds [Member] | Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 27,517 | 72,000 |
Money market funds [Member] | Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 0 | 0 |
Commercial paper [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 163,062 | 78,155 |
Commercial paper [Member] | Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 0 | 0 |
Commercial paper [Member] | Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 163,062 | 78,155 |
Corporate bonds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 120,529 | 72,091 |
Corporate bonds [Member] | Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 0 | 0 |
Corporate bonds [Member] | Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 120,529 | 72,091 |
U.S. Treasury and government sponsored enterprises [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 63,683 | 28,423 |
U.S. Treasury and government sponsored enterprises [Member] | Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 0 | 0 |
U.S. Treasury and government sponsored enterprises [Member] | Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | $ 63,683 | 28,423 |
Marketable equity securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 18 | |
Marketable equity securities [Member] | Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 18 | |
Marketable equity securities [Member] | Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | $ 0 |
Fair Value Measurements (Sche37
Fair Value Measurements (Schedule of Estimated Fair Value of Outstanding Debt) (Details) - USD ($) $ in Thousands | Jun. 30, 2016 | Dec. 31, 2015 |
Carrying Amount [Member] | Senior Subordinated Notes [Member] | Convertible Senior Subordinated Notes due 2019 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair values of financial instruments | $ 209,214 | $ 198,708 |
Carrying Amount [Member] | Secured Convertible Notes Due June 2018 [Member] | Deerfield Financing [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair values of financial instruments | 106,841 | 102,727 |
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 |
Fair Value [Member] | Senior Subordinated Notes [Member] | Convertible Senior Subordinated Notes due 2019 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair values of financial instruments | 427,283 | 336,260 |
Fair Value [Member] | Secured Convertible Notes Due June 2018 [Member] | Deerfield Financing [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair values of financial instruments | 111,226 | 101,096 |
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 | $ 79,717 | $ 79,815 |
Fair Value Measurements (Sche38
Fair Value Measurements (Schedule of Assumptions Used) (Details) | 6 Months Ended |
Jun. 30, 2016 | |
Deerfield Financing [Member] | Secured Convertible Notes Due June 2018 [Member] | Level 3 [Member] | |
Fair Value Inputs, Liabilities, Quantitative Information [Line Items] | |
Fair value inputs, discount rate (as a percent) | 15.00% |
Stock-Based Compensation (Sched
Stock-Based Compensation (Schedule of Allocated Employee Stock-Based Compensation Expenses) (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Total employee stock-based compensation expense | $ 3,558 | $ 1,734 | $ 14,743 | $ 3,394 |
Research and development expense [Member] | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Total employee stock-based compensation expense | 1,165 | 746 | 6,729 | 1,373 |
Selling, general and administrative expense [Member] | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Total employee stock-based compensation expense | $ 2,393 | $ 988 | $ 8,014 | $ 2,021 |
Stock-Based Compensation (Weigh
Stock-Based Compensation (Weighted Average Grant Date Fair Values) (Details) - $ / shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Stock Option [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Weighted average grant-date fair value (in dollars per share) | $ 3.17 | $ 2.41 | $ 2.67 | $ 1.28 |
ESPP [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Weighted average grant-date fair value (in dollars per share) | $ 1.60 | $ 1.11 | $ 1.79 | $ 0.85 |
Stock-Based Compensation (Sch41
Stock-Based Compensation (Schedule of Fair Value of Employee Share-Based Payments Awards Estimated Using the Assumptions) (Details) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Stock Option [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Risk-free interest rate | 0.90% | 1.27% | 1.10% | 1.20% |
Dividend yield | 0.00% | 0.00% | 0.00% | 0.00% |
Volatility | 67.00% | 106.00% | 76.00% | 89.00% |
Expected life | 4 years 4 months 13 days | 4 years 6 months | 4 years 4 months 9 days | 4 years 6 months |
ESPP [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Risk-free interest rate | 0.39% | 0.07% | 0.42% | 0.10% |
Dividend yield | 0.00% | 0.00% | 0.00% | 0.00% |
Volatility | 65.00% | 104.00% | 69.00% | 99.00% |
Expected life | 6 months | 6 months | 6 months | 6 months |
Stock-Based Compensation (Summa
Stock-Based Compensation (Summary of All Stock Option Activity) (Details) $ / shares in Units, $ in Thousands | 6 Months Ended |
Jun. 30, 2016USD ($)$ / sharesshares | |
Shares [Roll Forward] | |
Options outstanding at beginning of period, Shares | shares | 27,425,854 |
Granted, Shares | shares | 2,727,350 |
Exercised, Shares | shares | (1,321,802) |
Forfeited, Shares | shares | (197,038) |
Expired, Shares | shares | (80,516) |
Options outstanding at end of period, Shares | shares | 28,553,848 |
Exercisable at end of period, Shares | shares | 20,872,344 |
Weighted Average Exercise Price [Roll Forward] | |
Options outstanding at beginning of period, Weighted Average Exercise Price (in dollars per share) | $ / shares | $ 4.22 |
Granted, Weighted Average Exercise Price (in dollars per share) | $ / shares | 4.63 |
Exercised, Weighted Average Exercise Price (in dollars per share) | $ / shares | 1.89 |
Forfeited, Weighted Average Exercise Price (in dollars per share) | $ / shares | 4.32 |
Expired, Weighted Average Exercise Price (in dollars per share) | $ / shares | 10.89 |
Options outstanding at end of period, Weighted Average Exercise Price (in dollars per share) | $ / shares | 4.35 |
Exercisable at end of period, Weighted Average Exercise Price (in dollars per share) | $ / shares | $ 4.02 |
Options outstanding at end of period, Weighted Average Remaining Contractual Term | 4 years 8 months 4 days |
Exercisable at end of period, Weighted Average Remaining Contractual Term | 4 years 1 month 17 days |
Options outstanding at end of period, Aggregate Intrinsic Value, in dollars | $ | $ 112,155 |
Exercisable at end of period, Aggregate Intrinsic Value, in dollars | $ | $ 89,643 |
Stock-Based Compensation (Narra
Stock-Based Compensation (Narrative) (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | Dec. 31, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock-based compensation expense allocated | $ 3,558 | $ 1,734 | $ 14,743 | $ 3,394 | |
Stock Option [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of shares available for grant | 2,790,649 | 2,790,649 | |||
Unrecognized compensation expense | $ 17,700 | $ 17,700 | |||
Unrecognized compensation expense, weighted-average period for recognition (in years) | 3 years 7 days | ||||
Performance Stock Options [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of stock options vested, in shares | 5,870,303 | ||||
Stock-based compensation expense allocated | $ 4,100 | $ 3,300 | |||
Restricted Stock Units (RSUs) [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Unrecognized compensation expense | $ 3,700 | $ 3,700 | |||
Unrecognized compensation expense, weighted-average period for recognition (in years) | 2 years 10 months 17 days |
Stock-Based Compensation (Sum44
Stock-Based Compensation (Summary of All RSU Activity) (Details) $ / shares in Units, $ in Thousands | 6 Months Ended |
Jun. 30, 2016USD ($)$ / sharesshares | |
Restricted Stock Units (RSUs) [Member] | |
Shares [Roll Forward] | |
RSUs outstanding at beginning of period, Shares | 1,002,188 |
Awarded, Shares | 2,126,191 |
Vested and released, Shares | (1,215,756) |
Forfeited, Shares | (10,059) |
RSUs outstanding at end of period, Shares | 1,902,564 |
Weighted Average Grant DateFair Value [Roll Forward] | |
RSUs outstanding at beginning of period, Weighted Average Grant Date Fair Value (in dollars per share) | $ / shares | $ 5.16 |
Awarded, Weighted Average Grant Date Fair Value (in dollars per share) | $ / shares | 4.32 |
Vested and released, Weighted Average Grant Date Fair Value (in dollars per share) | $ / shares | 4.22 |
Forfeited, Weighted Average Grant Date Fair Value (in dollars per share) | $ / shares | 5.64 |
RSUs outstanding at end of period, Weighted Average Grant Date Fair Value (in dollars per share) | $ / shares | $ 4.82 |
RSUs outstanding at end of period, Weighted Average Remaining Contractual Term | 1 year 8 months 15 days |
RSUs outstanding at end of period, Aggregate Intrinsic Value, in dollars | $ | $ 15,544 |
Bonus RSU Grant [Member] | |
Shares [Roll Forward] | |
Awarded, Shares | 1,072,833 |
Weighted Average Grant DateFair Value [Roll Forward] | |
Grant date fair value | $ | $ 4,500 |
Net Loss Per Share (Details)
Net Loss Per Share (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Earnings Per Share [Abstract] | ||||
Net loss, in dollars | $ (37,015) | $ (43,362) | $ (98,362) | $ (78,532) |
Shares used in computing basic and diluted net loss per share | 229,310 | 196,201 | 228,860 | 196,052 |
Net loss per share, basic and diluted, in dollars per share | $ (0.16) | $ (0.22) | $ (0.43) | $ (0.40) |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total potentially dilutive shares | 119,645 | 118,057 | ||
Convertible debt [Member] | Convertible Senior Subordinated Notes due 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 2018 [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total potentially dilutive shares | 33,890 | 33,890 | ||
Outstanding stock options, unvested RSUs and ESPP contributions [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total potentially dilutive shares | 30,637 | 29,049 | ||
Warrants [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total potentially dilutive shares | 1,000 | 1,000 |
Concentrations of Credit Risk46
Concentrations of Credit Risk (Details) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Customer Concentration Risk [Member] | Accounts Receivable [Member] | Diplomat Specialty Pharmacy [Member] | ||||
Concentration Risk [Line Items] | ||||
Concentration risk, percentage | 43.00% | |||
Customer Concentration Risk [Member] | Accounts Receivable [Member] | Caremark L.L.C. [Member] | ||||
Concentration Risk [Line Items] | ||||
Concentration risk, percentage | 17.00% | |||
Customer Concentration Risk [Member] | Accounts Receivable [Member] | Affiliates of McKessen Corporation [Member] | ||||
Concentration Risk [Line Items] | ||||
Concentration risk, percentage | 10.00% | |||
Customer Concentration Risk [Member] | Product Sales [Member] | Diplomat Specialty Pharmacy [Member] | ||||
Concentration Risk [Line Items] | ||||
Concentration risk, percentage | 52.00% | 88.00% | 53.00% | 87.00% |
Customer Concentration Risk [Member] | Product Sales [Member] | Sobi [Member] | ||||
Concentration Risk [Line Items] | ||||
Concentration risk, percentage | 1.00% | 12.00% | 2.00% | 13.00% |
Customer Concentration Risk [Member] | Collaboration Agreements [Member] | Merck [Member] | ||||
Concentration Risk [Line Items] | ||||
Concentration risk, percentage | 0.00% | 0.00% | 10.00% | 0.00% |
Customer Concentration Risk [Member] | Collaboration Agreements [Member] | Ipsen [Member] | ||||
Concentration Risk [Line Items] | ||||
Concentration risk, percentage | 10.00% | 0.00% | 9.00% | 0.00% |
Geographic Concentration Risk [Member] | Product Sales [Member] | United States [Member] | ||||
Concentration Risk [Line Items] | ||||
Concentration risk, percentage | 89.00% | 88.00% | 89.00% | 87.00% |
Geographic Concentration Risk [Member] | Product Sales [Member] | European Union [Member] | ||||
Concentration Risk [Line Items] | ||||
Concentration risk, percentage | 11.00% | 12.00% | 11.00% | 13.00% |