Document_And_Entity_Informatio
Document And Entity Information | 9 Months Ended | |
Sep. 30, 2013 | Oct. 25, 2013 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | FALSE | |
Document Period End Date | 27-Sep-13 | |
Document Fiscal Year Focus | 2013 | |
Document Fiscal Period Focus | Q3 | |
Trading Symbol | exel | |
Entity Registrant Name | EXELIXIS, INC. | |
Entity Central Index Key | 939767 | |
Entity Filer Category | Large Accelerated Filer | |
Current Fiscal Year End Date | -15 | |
Entity Common Stock, Shares Outstanding | 184,204,393 |
Consolidated_Balance_Sheets
Consolidated Balance Sheets (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
In Thousands, unless otherwise specified | ||
ASSETS | ||
Cash and cash equivalents | $92,016 | $170,069 |
Short-term Investments | 187,203 | 241,371 |
Short-term restricted cash and investments | 12,211 | 12,246 |
Trade and other receivables | 5,171 | 2,751 |
Inventory | 1,764 | 0 |
Prepaid expenses and other current assets | 7,799 | 6,104 |
Total current assets | 306,164 | 432,541 |
Long-term investments | 157,402 | 182,311 |
Long-term restricted cash and investments | 15,889 | 27,964 |
Property and equipment, net | 5,520 | 6,059 |
Goodwill | 63,684 | 63,684 |
Other assets | 7,300 | 8,538 |
Total assets | 555,959 | 721,097 |
LIABILITIES AND STOCKHOLDERS' EQUITY | ||
Accounts payable | 3,559 | 4,398 |
Accrued clinical trial liabilities | 35,042 | 20,560 |
Accrued compensation and benefits | 9,342 | 10,375 |
Other accrued liabilities | 13,017 | 11,795 |
Current portion of convertible notes | 10,000 | 10,000 |
Current portion of loans payable | 2,127 | 3,170 |
Current portion of restructuring | 3,776 | 5,085 |
Deferred revenue | 1,017 | 16,321 |
Total current liabilities | 77,880 | 81,704 |
Long-term portion of convertible notes | 248,707 | 240,476 |
Long-term portion of loans payable | 80,757 | 82,090 |
Long-term portion of restructuring | 10,126 | 14,137 |
Other long-term liabilities | 5,726 | 6,256 |
Total liabilities | 423,196 | 424,663 |
Contingencies (Note 10) | ||
Stockholders' Equity: | ||
Preferred stock | 0 | 0 |
Common stock, $0.001 par value; 400,000,000 shares authorized; issued and outstanding: 184,194,124 and 183,697,213 shares at September 30, 2013 and December 31, 2012, respectively | 184 | 183 |
Additional paid-in capital | 1,560,415 | 1,550,345 |
Accumulated other comprehensive income (loss) | 180 | -92 |
Accumulated deficit | -1,428,016 | -1,254,002 |
Total stockholders’ equity | 132,763 | 296,434 |
Total liabilities and stockholders' equity | $555,959 | $721,097 |
Consolidated_Balance_Sheets_Pa
Consolidated Balance Sheets (Parenthetical) (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
Statement of Financial Position [Abstract] | ||
Common stock, par value, in dollars per share | $0.00 | $0.00 |
Common stock, shares authorized | 400,000,000 | 400,000,000 |
Common stock, shares issued | 184,194,124 | 183,697,213 |
Common stock, shares outstanding | 184,194,124 | 183,697,213 |
Consolidated_Statements_Of_Ope
Consolidated Statements Of Operations (USD $) | 3 Months Ended | 9 Months Ended | ||
In Thousands, except Per Share data, unless otherwise specified | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 |
Revenues: | ||||
License and contract revenues | $695 | $13,313 | $16,321 | $39,636 |
Net product revenues | 4,771 | 0 | 10,670 | 0 |
Total revenues | 5,466 | 13,313 | 26,991 | 39,636 |
Operating expenses: | ||||
Cost of goods sold | 290 | 0 | 855 | 0 |
Research and development | 47,354 | 30,680 | 129,166 | 96,386 |
Selling, general and administrative | 13,598 | 7,343 | 37,323 | 22,008 |
Restructuring charge | 137 | 733 | 865 | 1,704 |
Total operating expenses | 61,379 | 38,756 | 168,209 | 120,098 |
Loss from operations | -55,913 | -25,443 | -141,218 | -80,462 |
Other income (expense), net: | ||||
Interest income and other, net | 219 | 318 | 930 | 818 |
Interest expense | -11,430 | -7,679 | -33,726 | -15,775 |
Total other income (expense), net | -11,211 | -7,361 | -32,796 | -14,957 |
Loss before income taxes | -67,124 | -32,804 | -174,014 | -95,419 |
Income tax provision | 0 | 10 | 0 | 33 |
Net loss | ($67,124) | ($32,814) | ($174,014) | ($95,452) |
Net loss per share, basic and diluted, in dollars per share | ($0.36) | ($0.20) | ($0.95) | ($0.63) |
Shares used in computing basic and diluted net loss per share, in shares | 184,149 | 166,354 | 183,957 | 152,316 |
Consolidated_Statements_of_Com
Consolidated Statements of Comprehensive Loss (USD $) | 3 Months Ended | 9 Months Ended | ||||||
In Thousands, unless otherwise specified | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | ||||
Statement of Comprehensive Income [Abstract] | ||||||||
Net loss | ($67,124) | ($32,814) | ($174,014) | ($95,452) | ||||
Other comprehensive income (loss) | 443 | [1] | -23 | [1] | 272 | [1] | 120 | [1] |
Comprehensive loss | ($66,681) | ($32,837) | ($173,742) | ($95,332) | ||||
[1] | Other comprehensive income (loss) consisted solely of unrealized gains or losses on available for sale securities arising during the periods presented. There were no reclassification adjustments to net income 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. |
Consolidated_Statements_of_Cas
Consolidated Statements of Cash Flows (USD $) | 9 Months Ended | |
In Thousands, unless otherwise specified | Sep. 30, 2013 | Sep. 30, 2012 |
Cash flows from operating activities: | ||
Net loss | ($174,014) | ($95,452) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 2,382 | 4,071 |
Stock-based compensation expense | 8,503 | 6,222 |
Restructuring credit for property and equipment | 0 | -141 |
Accretion of debt discount | 19,445 | 8,624 |
Other | 5,243 | 3,450 |
Changes in assets and liabilities: | ||
Other receivables | -2,420 | 27,082 |
Inventory | -1,764 | 0 |
Prepaid expenses and other current assets | -1,495 | -1,892 |
Other assets | 0 | -1,983 |
Accounts payable and other accrued liabilities | -652 | 1,308 |
Clinical trial liability | 14,482 | 1,972 |
Restructuring liability | -5,320 | -3,489 |
Other long-term liabilities | -530 | -76 |
Deferred revenue | -15,304 | -34,106 |
Net cash used in operating activities | -151,444 | -84,410 |
Cash flows from investing activities: | ||
Purchases of property and equipment | -2,079 | -1,528 |
Proceeds from sale of property and equipment | 40 | 877 |
Proceeds from maturities of restricted cash and investments | 15,968 | 4,199 |
Purchase of restricted cash and investments | -3,785 | -40,188 |
Proceeds from maturities of investments | 251,470 | 236,323 |
Purchases of investments | -176,768 | -359,524 |
Net cash provided by (used in) investing activities | 84,846 | -159,841 |
Cash flows from financing activities: | ||
Proceeds from issuance of common stock, net | 0 | 203,479 |
Proceeds from exercise of stock options and warrants | 25 | 901 |
Proceeds from employee stock purchase plan | 894 | 828 |
Proceeds from debt issuance, net | 0 | 277,673 |
Principal payments on debt | -12,374 | -4,082 |
Net cash (used in) provided by financing activities | -11,455 | 478,799 |
Net (decrease) increase in cash and cash equivalents | -78,053 | 234,548 |
Cash and cash equivalents at beginning of period | 170,069 | 74,257 |
Cash and cash equivalents at end of period | $92,016 | $308,805 |
Organization_and_Summary_of_Si
Organization and Summary of Significant Accounting Policies | 45 Months Ended |
Sep. 30, 2013 | |
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 biotechnology company committed to developing small molecule therapies for the treatment of cancer. We are focusing our proprietary resources and development and commercialization efforts exclusively on COMETRIQ® (cabozantinib), our wholly-owned inhibitor of multiple receptor tyrosine kinases. On November 29, 2012, the U.S. Food and Drug Administration approved COMETRIQ for the treatment of progressive, metastatic medullary thyroid cancer (“MTC”), in the United States, where it became commercially available in late January 2013. Cabozantinib is being evaluated in a variety of other cancer indications through a broad development program, including two ongoing phase 3 pivotal trials in metastatic castration-resistant prostate cancer, an ongoing phase 3 pivotal trial in metastatic renal cell cancer and an ongoing phase 3 pivotal trial in advanced hepatocellular cancer. We believe COMETRIQ has the potential to be a high-quality, broadly-active and differentiated anti-cancer agent that can make a meaningful difference in the lives of patients. Our objective is to develop COMETRIQ into a major oncology franchise, and we believe that the approval of COMETRIQ for the treatment of progressive, metastatic MTC provides us with the opportunity to establish a commercial presence in furtherance of this objective. | |
We have also established a portfolio of other novel compounds that we believe have the potential to address serious unmet medical needs. Many of these compounds are being developed by partners as part of collaborations, at no cost to us but with significant retained economics to us in the event these compounds are commercialized. As disclosed on ClinicalTrials.gov (NCT01689519), a phase 3 clinical trial for one of these compounds, cobimetinib (GDC-0973/XL518), which we out-licensed to Genentech, Inc. (a wholly-owned member of the Roche Group), was initiated on November 1, 2012. | |
Basis of Consolidation | |
The consolidated financial statements include the accounts of Exelixis and those of our wholly-owned subsidiaries, including Exelixis International (Bermuda) Ltd. (“Exelixis Bermuda”). In September 2013, Exelixis engaged in intercompany transactions whereby Exelixis Bermuda acquired the existing and future intellectual property rights to exploit cabozantinib in jurisdictions outside of the United States. All intercompany balances and transactions have been eliminated. | |
Basis of Presentation | |
The accompanying unaudited consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States for interim financial information and pursuant to Form 10-Q and Article 10 of Regulation S-X of the Securities and Exchange Commission (“SEC”). Accordingly, they do not include all of the information and footnotes required by U.S. generally accepted accounting principles for complete financial statements. In our opinion, all adjustments (consisting only of normal recurring adjustments) considered necessary for a fair presentation of the results of operations and cash flows for the period presented have been included. | |
Exelixis adopted a 52- or 53-week fiscal year that generally ends on the Friday closest to December 31st. Fiscal year 2012, a 52-week year, ended on December 28, 2012, and fiscal year 2013, a 52-week year, will end on December 27, 2013. For convenience, references in this report as of and for the fiscal quarters ended September 28, 2012 and September 27, 2013, and as of the fiscal year ended December 28, 2012, are indicated as ended September 30, 2012, September 30, 2013, and December 31, 2012, respectively. | |
Operating results for the three and nine months ended September 30, 2013 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2013 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 fiscal year ended December 31, 2012, included in our Annual Report on Form 10-K filed with the SEC on February 21, 2013. | |
Segment Information | |
We operate in one business segment. | |
Use of Estimates | |
The preparation of the consolidated financial statements is in conformity with accounting principles generally accepted in the United States which requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosures. On an ongoing basis, management evaluates its estimates including, but not limited to, those related to inventory, revenue recognition, cost of goods sold, valuation of long-lived assets, certain accrued liabilities including clinical trial accruals and restructuring liability, share-based compensation and the valuation of the debt and equity components of our convertible debt at issuance. We base our estimates on historical experience and on various other market-specific and other relevant assumptions that are believed 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. | |
Inventory | |
We consider regulatory approval of product candidates to be uncertain and product manufactured prior to regulatory approval may not be sold unless regulatory approval is obtained. As such, the manufacturing costs for product candidates incurred prior to regulatory approval are not capitalized as inventory but rather are expensed as research and development costs. When regulatory approval is obtained, we begin capitalization of inventory related costs. We received regulatory approval for our first product, COMETRIQ, on November 29, 2012. | |
Inventory is valued at the lower of cost or net realizable value. We determine the cost of inventory using the standard-cost method, which approximates actual cost based on a first-in, first-out method. We analyze our inventory levels quarterly and write down inventory that has become obsolete, or has a cost basis in excess of its expected net realizable value and inventory quantities in excess of expected requirements. Expired inventory is disposed of and the related costs are recognized as cost of goods sold in the Consolidated Statements of Operations. | |
Goodwill | |
Goodwill amounts have been recorded as the excess purchase price over tangible assets, liabilities and intangible assets acquired based on their estimated fair value, by applying the purchase method. Goodwill is not subject to amortization. We evaluate goodwill for impairment on an annual basis and on an interim basis if events or changes in circumstances between annual impairment tests indicate that the asset might be impaired. When evaluating goodwill for impairment we must determine the reporting units that exist within Exelixis. We have determined that we have one reporting unit, which is consistent with our sole operating segment as of September 30, 2013 and December 31, 2012. | |
Revenue Recognition | |
We recognize revenue from the sale of COMETRIQ and from license fees and milestones earned on research and collaboration 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, 2012 for a description of our policies for revenue recognition on research and collaboration agreements. We did not enter into any new collaboration agreements during the nine months ended September 30, 2013. 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, 2012 for a description of our existing collaboration agreements. | |
Net Product Revenues | |
We recognize revenue when it is both realized or realizable and earned, meaning persuasive evidence of an arrangement exists, delivery has occurred, title has transferred, the price is fixed or determinable, there are no remaining customer acceptance requirements, and collectability of the resulting receivable is reasonably assured. For product sales in the United States, this generally occurs upon shipment of the product to the patient. For product sales in Europe, this occurs when our European distribution partner has accepted the product. | |
We sell our product, COMETRIQ, in the United States to a specialty pharmacy that benefits from customer incentives and has a right of return. We have a limited sales history and cannot reliably estimate expected returns of the product nor the discounts and rebates due to payors at the time of shipment to the specialty pharmacy. Accordingly, upon shipment to the specialty pharmacy, we record deferred revenue on our Consolidated Balance Sheets. We recognize revenue when the specialty pharmacy provides the product to a patient based on the fulfillment of a prescription. We record revenue using an analysis of prescription data from our specialty pharmacy to ascertain the date of shipment and the payor mix. This approach is frequently referred to as the “sell-through” revenue recognition model. Once the prescription has been provided to the patient, it is not subject to return unless the product is damaged. | |
Product sales to our European distribution partner are not subject to customer incentives, rights of return or discounts and allowances. We record revenue at the time our European distribution partner has accepted the product, a method also known as the “sell-in” revenue recognition model. | |
Product Sales Discounts and Allowances | |
We calculate gross product revenues based on the price that we charge our United States specialty pharmacy and our European distribution partner. We estimate our net product revenues by deducting from our gross product revenues (a) trade allowances, such as discounts for prompt payment, (b) estimated government rebates and chargebacks, and (c) estimated costs of patient assistance programs. We initially record estimates for these deductions at the time we recognize the gross revenue. We update our estimates on a recurring basis as new information becomes available. These discounts and allowances apply only to gross product revenues earned in the United States. | |
Customer Credits: The United States specialty pharmacy receives a discount of 2% for prompt payment. We expect this specialty pharmacy will earn 100% of its prompt payment discounts and, therefore, we deduct the full amount of these discounts from total product sales when revenues are recognized. | |
Mandated Rebates: Allowances for rebates include mandated discounts under the Medicaid Drug Rebate Program and other government programs. Rebate amounts owed after the final dispensing of the product to a benefit plan participant are based upon contractual agreements or legal requirements with public sector benefit providers, such as Medicaid. The allowance for rebates is based on statutory discount rates and expected utilization. Our estimates for the expected utilization of rebates are based on customer and payor data received from the United States specialty pharmacy. Rebates are generally invoiced by the payor and paid in arrears, such that the accrual balance consists of an estimate of the amount expected to be incurred for the current quarter’s shipments to patients, plus an accrual balance for known prior quarter’s unpaid rebates. If actual future rebates vary from estimates, we may need to adjust our accruals, which would affect net revenue in the period of adjustment. | |
Chargebacks: Chargebacks are discounts that occur when contracted customers purchase directly from a specialty pharmacy. Contracted customers, which currently consist primarily of Public Health Service institutions, non-profit clinics, and Federal government entities purchasing via the Federal Supply Schedule, generally purchase the product at a discounted price. The United States specialty pharmacy, in turn, charges back to us the difference between the price initially paid by the specialty pharmacy and the discounted price paid to the specialty pharmacy by the customer. The allowance for chargebacks is based on sales to contracted customers. | |
Medicare Part D Coverage Gap: In the United States, the Medicare Part D prescription drug benefit mandates manufacturers to fund 50% of the Medicare Part D insurance coverage gap for prescription drugs sold to eligible patients. Our estimates for expected Medicare Part D coverage gap are based in part on third party market research data and on customer and payor data received from the United States specialty pharmacy. Funding of the coverage gap is invoiced and paid in arrears so that the accrual balance consists of an estimate of the amount expected to be incurred for the current quarter's shipments to patients, plus an accrual balance for prior sales. If actual future funding varies from estimates, we may need to adjust our accruals, which would affect net revenue in the period of adjustment. | |
Co-payment Assistance: Patients who have commercial insurance and meet certain eligibility requirements may receive co-payment assistance. We accrue a liability for co-payment assistance based on actual program participation and estimates of program redemption using customer data provided by our United States specialty pharmacy. | |
Patient Assistance Program | |
We provide COMETRIQ at no cost to eligible patients who have no insurance and meet certain financial and clinical criteria through our Patient Assistance Program (“PAP”). We record the cost of the product as a selling, general and administrative expense at the time the product is designated as PAP inventory. | |
Cost of Goods Sold | |
Cost of goods sold is related to our product revenues and consists primarily a 3% royalty we are required to pay GlaxoSmithKline and indirect labor costs. A significant portion of the manufacturing costs for current product sales were incurred prior to regulatory approval of COMETRIQ for the treatment of progressive, metastatic MTC and, therefore, were expensed as research and development costs when incurred, rather than capitalized as inventory. | |
In accordance with our 2002 collaboration agreement with GlaxoSmithKline, we are required to pay GlaxoSmithKline a 3% royalty on the Net Sales of any product incorporating cabozantinib, including COMETRIQ. Net Sales is defined in the collaboration agreement generally as the gross invoiced sales price less customer credits, rebates, chargebacks, shipping costs, customs duties, and sales tax and other similar tax payments we are required to make. | |
Recently Adopted Accounting Pronouncements | |
In February 2013, Accounting Standards Codification Topic 220, Comprehensive Income was amended to require additional information about amounts reclassified out of accumulated other comprehensive income. We adopted this guidance beginning January 1, 2013, and will provide the additional information when such reclassifications occur. The amendment did not have a material effect on our consolidated financial statements. |
Restructurings
Restructurings | 9 Months Ended | |||||||||||||||||||
Sep. 30, 2013 | ||||||||||||||||||||
Restructuring Charges [Abstract] | ||||||||||||||||||||
Restructurings | RESTRUCTURINGS | |||||||||||||||||||
Between March 2010 and May 2013, we implemented five restructurings (referred to collectively as the “Restructurings”) as a consequence of our decision to focus our proprietary resources and development efforts on the development and commercialization of cabozantinib and strategy to manage costs. The aggregate reduction in headcount from the Restructurings was 429 employees. Charges and credits related to the Restructurings were recorded in periods other than those in which the Restructurings were implemented as a result of sublease activities for certain of our buildings in South San Francisco, California, changes in assumptions regarding anticipated sublease activities, the effect of the passage of time on our discounted cash flow computations, previously planned employee terminations, and sales of excess equipment and other assets. | ||||||||||||||||||||
We have recorded aggregate restructuring charges of $52.9 million in connection with the Restructurings, of which $28.9 million related to facility charges, $21.7 million related to termination benefits, $2.2 million related to the impairment of excess equipment and other assets, and an additional minor amount related to legal and other fees. Asset impairment charges, net were partially offset by cash proceeds of $2.6 million from the sale of such assets. | ||||||||||||||||||||
For the nine months ended September 30, 2013 and 2012, we recorded restructuring charges of $0.9 million and $1.7 million, respectively, which related primarily to termination benefits and facility charges in connection with the exit of portions of certain of our buildings in South San Francisco. Those charges were partially offset by a $0.7 million credit resulting from a new sublease entered into during the three months ended September 30, 2013. | ||||||||||||||||||||
The total outstanding restructuring liability related to the Restructurings is included in current and long-term portion of restructuring on our Consolidated Balance Sheets. The components and changes of these liabilities during the annual periods from inception of the restructuring activities through the year ended December 31, 2012 and during the nine months ended September 30, 2013 are summarized in the following table (in thousands): | ||||||||||||||||||||
Employee | Facility | Asset | Legal and | Total | ||||||||||||||||
Severance | Charges | Impairment | Other Fees | |||||||||||||||||
and Other Benefits | ||||||||||||||||||||
Restructuring liability as of December 31, 2011 | $ | 6 | $ | 13,921 | $ | — | $ | 51 | $ | 13,978 | ||||||||||
Restructuring charge (credit) | 970 | 8,276 | (47 | ) | (28 | ) | 9,171 | |||||||||||||
Cash payments | (965 | ) | (5,299 | ) | — | (3 | ) | (6,267 | ) | |||||||||||
Adjustments or non-cash credits including stock compensation expense | (11 | ) | 2,304 | (891 | ) | — | 1,402 | |||||||||||||
Proceeds from sale of assets | — | — | 938 | — | 938 | |||||||||||||||
Restructuring liability as of December 31, 2012 | — | 19,202 | — | 20 | 19,222 | |||||||||||||||
Restructuring charge (credit) | 496 | 359 | 25 | (15 | ) | 865 | ||||||||||||||
Cash payments | (424 | ) | (5,608 | ) | — | — | (6,032 | ) | ||||||||||||
Adjustments or non-cash credits including stock compensation expense | (55 | ) | (73 | ) | (25 | ) | — | (153 | ) | |||||||||||
Restructuring liability as of | $ | 17 | $ | 13,880 | $ | — | $ | 5 | $ | 13,902 | ||||||||||
30-Sep-13 | ||||||||||||||||||||
We expect to pay accrued facility charges of $13.9 million, net of cash received from our subtenants, through 2017, or the end of our lease terms of the buildings. With respect to our Restructurings, we expect to incur additional restructuring charges of approximately $1.8 million which relate to the exit, in prior periods, of certain of our South San Francisco buildings. These charges will be recorded through the end of the building lease terms, the last of which ends in 2017. | ||||||||||||||||||||
The Restructurings have resulted in aggregate cash expenditures of $34.8 million, net of $9.1 million in cash received from subtenants and $2.6 million in cash received in connection with the sale of excess equipment and other assets. Net cash expenditures for the Restructurings were $2.1 million and $2.2 million during the three months ended September 30, 2013, and 2012, respectively and $6.0 million and $4.5 million during the nine months ended September 30, 2013 and 2012, respectively. | ||||||||||||||||||||
The restructuring charges that we expect to incur in connection with the Restructurings are subject to a number of assumptions, and actual results may materially differ. We may also incur other material charges not currently contemplated due to events that may occur as a result of, or associated with, the Restructurings. |
Cash_and_Investments
Cash and Investments | 9 Months Ended | |||||||||||||||
Sep. 30, 2013 | ||||||||||||||||
Investments, Debt and Equity Securities [Abstract] | ||||||||||||||||
Cash and Investments | CASH AND INVESTMENTS | |||||||||||||||
The following table summarizes cash and cash equivalents, investments, and restricted cash and investments by balance sheet line item as of September 30, 2013 and December 31, 2012 (in thousands): | ||||||||||||||||
September 30, 2013 | ||||||||||||||||
Amortized | Gross | Gross | Fair Value | |||||||||||||
Cost | Unrealized | Unrealized | ||||||||||||||
Gains | Losses | |||||||||||||||
As reported: | ||||||||||||||||
Cash and cash equivalents | $ | 92,016 | $ | — | $ | — | $ | 92,016 | ||||||||
Short-term investments | 187,086 | 141 | (24 | ) | 187,203 | |||||||||||
Short-term restricted cash and investments | 12,172 | 39 | — | 12,211 | ||||||||||||
Long-term investments | 157,437 | 63 | (98 | ) | 157,402 | |||||||||||
Long-term restricted cash and investments | 15,830 | 59 | — | 15,889 | ||||||||||||
Total cash and investments | $ | 464,541 | $ | 302 | $ | (122 | ) | $ | 464,721 | |||||||
December 31, 2012 | ||||||||||||||||
Amortized | Gross | Gross | Fair Value | |||||||||||||
Cost | Unrealized | Unrealized | ||||||||||||||
Gains | Losses | |||||||||||||||
As reported: | ||||||||||||||||
Cash and cash equivalents | $ | 170,070 | $ | — | $ | (1 | ) | $ | 170,069 | |||||||
Short-term investments | 241,391 | 46 | (66 | ) | 241,371 | |||||||||||
Short-term restricted cash and investments | 12,242 | 4 | — | 12,246 | ||||||||||||
Long-term investments | 182,407 | 28 | (124 | ) | 182,311 | |||||||||||
Long-term restricted cash and investments | 27,943 | 21 | — | 27,964 | ||||||||||||
Total cash and investments | $ | 634,053 | $ | 99 | $ | (191 | ) | $ | 633,961 | |||||||
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 and certain other designated financial institutions. The total collateral balances as of September 30, 2013 and December 31, 2012 were $84.5 million and $87.0 million, respectively, and are reflected in our Consolidated Balance Sheets in short- and long-term investments. See “Note 7 - Debt” to our Consolidated Financial Statements included in our Annual Report on Form 10-K for the year ended December 31, 2012, for more information regarding the collateral balance requirements under our Silicon Valley Bank loan and security agreement. | ||||||||||||||||
All of our cash equivalents and investments are classified as available-for-sale. The following table summarizes our cash and cash equivalents and investments by security type as of September 30, 2013 and December 31, 2012 (in thousands): | ||||||||||||||||
September 30, 2013 | ||||||||||||||||
Amortized | Gross | Gross | Fair Value | |||||||||||||
Cost | Unrealized | Unrealized | ||||||||||||||
Gains | Losses | |||||||||||||||
Cash and money market funds | $ | 62,645 | $ | — | $ | — | $ | 62,645 | ||||||||
Commercial paper | 43,591 | 1 | — | 43,592 | ||||||||||||
Corporate bonds | 266,700 | 173 | (122 | ) | 266,751 | |||||||||||
U.S. Treasury and government sponsored enterprises | 83,323 | 119 | — | 83,442 | ||||||||||||
Municipal bonds | 8,282 | 9 | — | 8,291 | ||||||||||||
Total cash and investments | $ | 464,541 | $ | 302 | $ | (122 | ) | $ | 464,721 | |||||||
December 31, 2012 | ||||||||||||||||
Amortized | Gross | Gross | Fair Value | |||||||||||||
Cost | Unrealized | Unrealized | ||||||||||||||
Gains | Losses | |||||||||||||||
Cash and money market funds | $ | 81,744 | $ | 2 | $ | — | $ | 81,746 | ||||||||
Commercial paper | 167,223 | 8 | — | 167,231 | ||||||||||||
Corporate bonds | 222,106 | 30 | (187 | ) | 221,949 | |||||||||||
U.S. Treasury and government sponsored enterprises | 132,933 | 59 | (1 | ) | 132,991 | |||||||||||
Municipal bonds | 30,047 | — | (3 | ) | 30,044 | |||||||||||
Total cash and investments | $ | 634,053 | $ | 99 | $ | (191 | ) | $ | 633,961 | |||||||
All of our investments are subject to a quarterly impairment review. During the three and nine months ended September 30, 2013 and 2012, we did not record any other-than-temporary impairment charges on our available-for-sale securities. As of September 30, 2013, the fair value of investments that were in an unrealized loss position was $106.8 million, including $105.8 million in corporate bonds. There were 53 investments in an unrealized loss position as of September 30, 2013. All investments in an unrealized loss position have been so for less than one year and the unrealized losses were not attributed to credit risk, but rather associated with the changes in interest rates. Based on the scheduled maturities of our investments, we concluded that the unrealized losses in our investment securities are not other-than-temporary, as it is more likely than not that we will hold these investments for a period of time sufficient for a recovery of our cost basis. | ||||||||||||||||
The following summarizes the fair value of securities classified as available-for-sale by contractual maturity as of September 30, 2013 (in thousands): | ||||||||||||||||
Mature within One Year | After One Year through Two Years | Fair Value | ||||||||||||||
Money market funds | $ | 58,102 | $ | — | $ | 58,102 | ||||||||||
Commercial paper | 43,592 | — | 43,592 | |||||||||||||
Corporate bonds | 168,715 | 98,036 | 266,751 | |||||||||||||
U.S. Treasury and government sponsored enterprises | 71,279 | 12,163 | 83,442 | |||||||||||||
Municipal bonds | 2,212 | 6,079 | 8,291 | |||||||||||||
Total | $ | 343,900 | $ | 116,278 | $ | 460,178 | ||||||||||
The classification of certain compensating balances and restricted investments are dependent upon the term of the underlying restriction on the asset and not the maturity date of the investment. Therefore, certain long-term investments and long-term restricted cash and investments have contractual maturities within one year. | ||||||||||||||||
During the three and nine months ended September 30, 2013 and 2012, there were no sales of investments, and therefore there were no reclassification adjustments of accumulated other comprehensive income to net income resulting from realized gains or losses on the sale of securities. |
Inventory
Inventory | 9 Months Ended | |||||||
Sep. 30, 2013 | ||||||||
Inventory Disclosure [Abstract] | ||||||||
Inventory | INVENTORY | |||||||
Inventory consists of the following (in thousands): | ||||||||
September 30, | December 31, | |||||||
2013 | 2012 | |||||||
Raw materials | $ | 301 | $ | — | ||||
Work in process | 1,374 | — | ||||||
Finished goods | 89 | — | ||||||
Total | $ | 1,764 | $ | — | ||||
We received regulatory approval for our first product, COMETRIQ, on November 29, 2012. As of December 31, 2012, our recorded inventory balance was $0 as we did not incur any costs that would be recorded as inventory subsequent to the receipt of regulatory approval and prior to year end. |
Debt
Debt | 9 Months Ended | |||||||
Sep. 30, 2013 | ||||||||
Debt Disclosure [Abstract] | ||||||||
Debt | DEBT | |||||||
The amortized carrying amount of our debt consists of the following (in thousands): | ||||||||
September 30, | December 31, | |||||||
2013 | 2012 | |||||||
Convertible Senior Subordinated Notes due 2019 | $ | 161,279 | $ | 149,800 | ||||
Secured Convertible Notes due 2015 | 97,428 | 100,676 | ||||||
Silicon Valley Bank term loan | 80,000 | 80,000 | ||||||
Silicon Valley Bank line of credit | 2,884 | 5,260 | ||||||
Total debt | 341,591 | 335,736 | ||||||
Less: current portion | (12,127 | ) | (13,170 | ) | ||||
Long-term debt | $ | 329,464 | $ | 322,566 | ||||
See “Note 7 - Debt” to our Consolidated Financial Statements included in our Annual Report on Form 10-K for the year ended December 31, 2012, for additional information on the terms of our debt, including a description of the conversion features of the of 4.25% Convertible Senior Subordinated Notes due 2019 (the “2019 Notes”) and our Secured Convertible Notes due June 2015 (the “Deerfield Notes”). | ||||||||
Convertible Senior Subordinated Notes due 2019 | ||||||||
In August 2012, we issued and sold $287.5 million aggregate principal amount the 2019 Notes. As of September 30, 2013, the entire principal balance remains outstanding. The following is a summary of the liability component of the 2019 Notes as of September 30, 2013 (in thousands): | ||||||||
September 30, | ||||||||
2013 | ||||||||
Net carrying amount of the liability component | $ | 161,279 | ||||||
Unamortized discount of the liability component | 126,221 | |||||||
Face amount of the 2019 Notes | $ | 287,500 | ||||||
The debt discount and debt issuance costs will be amortized as interest expense through August 2019. During the three and nine months ended September 30, 2013, total interest expense for the 2019 Notes was $7.2 million, and $21.2 million, respectively, including stated coupon interest of $3.1 million and $9.2 million, respectively, and the amortization of the debt discount and debt issuance costs of $4.1 million and $12.0 million, respectively. During both the three and nine months ended September 30, 2012, total interest expense for the 2019 Notes was $3.4 million including stated coupon interest of $1.5 million and the amortization of the debt discount and debt issuance costs of $1.9 million. The balance of unamortized fees and costs was $4.1 million and $4.7 million as of September 30, 2013 and December 31, 2012, respectively, which is recorded in the accompanying Consolidated Balance Sheet as Other assets. | ||||||||
Secured Convertible Notes due June 2015 | ||||||||
In June 2010, we entered into a note purchase agreement with entities affiliated with Deerfield Management Company, L.P. (“Deerfield”), pursuant to which, on July 1, 2010, we sold to Deerfield an aggregate of $124.0 million initial principal amount of the Deerfield Notes. As of September 30, 2013 and December 31, 2012, the remaining outstanding principal balance on the Deerfield Notes was $114.0 million and $124.0 million, respectively. During the three and nine months ended September 30, 2013, total interest expense for the Deerfield Notes was $4.1 million and $11.9 million, respectively, and during the same periods in 2012, $4.1 million and $11.7 million, respectively, including the stated coupon rate and the amortization of the debt discount and debt issuance costs. The non-cash expense relating to the amortization of the debt discount and debt issuance costs were $2.6 million and $7.4 million during the three and nine months ended September 30, 2013, respectively, and $2.5 million and $7.2 million, during the three and nine months ended September 30, 2012, respectively. The balance of unamortized fees and costs was $1.6 million and $2.3 million as of September 30, 2013 and December 31, 2012, respectively, which is recorded in the accompanying Consolidated Balance Sheet as Other assets. | ||||||||
We also entered into a security agreement in favor of Deerfield, which provides that our obligations under the Deerfield Notes will be secured by substantially all of our assets except intellectual property. On August 1, 2013, the parties amended the security agreement to limit the extent to which voting equity interests in any of our foreign subsidiaries shall be secured assets. |
Fair_Value_Measurements
Fair Value Measurements | 9 Months Ended | |||||||||||||||
Sep. 30, 2013 | ||||||||||||||||
Fair Value Disclosures [Abstract] | ||||||||||||||||
Fair Value Measurements | FAIR VALUE MEASUREMENTS | |||||||||||||||
The fair value of our financial instruments reflects the amounts that would be received upon sale of an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date (exit price). The fair value hierarchy has the following three levels: | ||||||||||||||||
Level 1 – quoted prices in active markets for identical assets and liabilities. | ||||||||||||||||
Level 2 – observable inputs other than quoted prices in active markets for identical assets and liabilities. These inputs include using prices from independent pricing services based on quoted prices in active markets for similar instruments or on industry models using data inputs, such as interest rates and prices that can be directly observed or corroborated in active markets. | ||||||||||||||||
Level 3—unobservable inputs. | ||||||||||||||||
A review of the fair value hierarchy classification is conducted on a quarterly basis. Changes in the observability of valuation inputs may result in a reclassification of levels for certain investments within the fair value hierarchy. There were no transfers between any of the fair value hierarchies, as determined at the end of each reporting period. | ||||||||||||||||
The following table sets forth the fair value of our financial assets that were measured and recorded on a recurring basis as of September 30, 2013 and December 31, 2012. We did not have any Level 3 investments during the periods presented. The amounts presented exclude cash, but include investments classified as cash equivalents (in thousands): | ||||||||||||||||
September 30, 2013 | ||||||||||||||||
Level 1 | Level 2 | Total | ||||||||||||||
Money market funds | $ | 58,102 | $ | — | $ | 58,102 | ||||||||||
Commercial paper | — | 43,592 | 43,592 | |||||||||||||
Corporate bonds | — | 266,751 | 266,751 | |||||||||||||
U.S. Treasury and government sponsored enterprises | — | 83,442 | 83,442 | |||||||||||||
Municipal bonds | — | 8,291 | 8,291 | |||||||||||||
Total | $ | 58,102 | $ | 402,076 | $ | 460,178 | ||||||||||
December 31, 2012 | ||||||||||||||||
Level 1 | Level 2 | Total | ||||||||||||||
Money market funds | $ | 76,050 | $ | — | $ | 76,050 | ||||||||||
Commercial paper | — | 167,231 | 167,231 | |||||||||||||
Corporate bonds | — | 221,949 | 221,949 | |||||||||||||
U.S. Treasury and government sponsored enterprises | — | 132,991 | 132,991 | |||||||||||||
Municipal bonds | — | 30,044 | 30,044 | |||||||||||||
Total | $ | 76,050 | $ | 552,215 | $ | 628,265 | ||||||||||
The estimated fair values of our financial instruments that are carried at amortized cost for which it is practicable to determine a fair value were as follows (in thousands): | ||||||||||||||||
September 30, 2013 | December 31, 2012 | |||||||||||||||
Carrying | Fair Value | Carrying | Fair Value | |||||||||||||
Amount | Amount | |||||||||||||||
2019 Notes | $ | 161,279 | $ | 337,928 | $ | 149,800 | $ | 280,111 | ||||||||
Silicon Valley Bank term loan | $ | 80,000 | $ | 79,884 | $ | 80,000 | $ | 79,542 | ||||||||
Silicon Valley Bank Line of Credit | $ | 2,884 | $ | 2,884 | $ | 5,260 | $ | 5,253 | ||||||||
There is no practicable method to determine the fair value of the Deerfield Notes due to the unique structure of the instrument that was financed by entities affiliated with Deerfield and the current non-liquid market in structured notes. The carrying amounts of cash, trade and other receivables, accounts payable and accrued clinical trial liabilities approximate their fair values and are excluded from the tables above. | ||||||||||||||||
The following methods and assumptions were used to estimate the fair value of each class of financial instrument for which it is practicable to estimate a value: | ||||||||||||||||
• | When available, we value investments based on quoted prices for those financial instruments, which is a Level 1 input. Our remaining investments are valued using third-party pricing sources, which use observable market prices, interest rates and yield curves observable at commonly quoted intervals of similar assets as observable inputs for pricing, which is a Level 2 input. | |||||||||||||||
• | The 2019 Notes are valued using a third-party pricing model that is based in part on average trading prices, which is a Level 2 input. The 2019 Notes are not marked-to-market and are shown at their initial fair value less the unamortized discount; the portion of the value allocated to the conversion option is included in Stockholders’ equity in the accompanying Consolidated Balance Sheets. | |||||||||||||||
• | We have estimated the fair value of our other debt instruments, where possible, using the net present value of the payments discounted at an interest rate that is consistent with money-market rates that would have been earned on our non-interest-bearing compensating balances, which is a Level 2 input. |
StockBased_Compensation
Stock-Based Compensation | 9 Months Ended | |||||||||||||||
Sep. 30, 2013 | ||||||||||||||||
Share-based Compensation [Abstract] | ||||||||||||||||
Stock-Based Compensation | STOCK-BASED COMPENSATION | |||||||||||||||
We recorded and allocated employee stock-based compensation expenses for our equity incentive plans and our 2000 Employee Stock Purchase Plan (“ESPP”) as follows (in thousands): | ||||||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2013 | 2012 | 2013 | 2012 | |||||||||||||
Research and development expense | $ | 1,415 | $ | 970 | $ | 4,326 | $ | 3,202 | ||||||||
Selling, general and administrative expense | 1,478 | 923 | 4,115 | 2,970 | ||||||||||||
Restructuring-related stock-based compensation expense | — | — | 49 | — | ||||||||||||
Total employee stock-based compensation expense | $ | 2,893 | $ | 1,893 | $ | 8,490 | $ | 6,172 | ||||||||
We use the Black-Scholes option pricing model to value our stock options. The expected life computation is based on historical exercise patterns and post-vesting termination behavior. We considered implied volatility as well as our historical volatility in developing our estimate of expected volatility. The fair value of employee stock option awards and ESPP purchases was estimated using the following assumptions and weighted average fair values: | ||||||||||||||||
Stock Options | ||||||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2013 | 2012 | 2013 | 2012 | |||||||||||||
Weighted average grant-date fair value | $ | 2.99 | $ | 3.31 | $ | 2.92 | $ | 3.27 | ||||||||
Risk-free interest rate | 1.57 | % | 0.81 | % | 1.47 | % | 0.82 | % | ||||||||
Dividend yield | — | % | — | % | — | % | — | % | ||||||||
Volatility | 60 | % | 69 | % | 60 | % | 69 | % | ||||||||
Expected life | 5.6 years | 5.6 years | 5.6 years | 5.7 years | ||||||||||||
Employee Stock Purchase Plan | ||||||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2013 | 2012 | 2013 | 2012 | |||||||||||||
Weighted average grant-date fair value | $ | 1.74 | $ | 1.63 | $ | 1.66 | $ | 2.13 | ||||||||
Risk-free interest rate | 0.08 | % | 0.15 | % | 0.12 | % | 0.1 | % | ||||||||
Dividend yield | — | % | — | % | — | % | — | % | ||||||||
Volatility | 67 | % | 68 | % | 67 | % | 68 | % | ||||||||
Expected life | 0.5 years | 0.5 years | 0.5 years | 0.5 years | ||||||||||||
Of the stock options outstanding as of September 30, 2013, 3,720,752 were granted subject to performance objectives tied to the achievement of clinical goals set by the Compensation Committee of our Board of Directors and will vest in full or part based on achievement of such goals. As of September 30, 2013, we expect that achievement of some of those performance objectives is probable and have, therefore, included stock-based compensation for such awards. We have not included any stock-based compensation expense for stock options with performance objectives where the performance goals cannot be reasonably assured of achievement. | ||||||||||||||||
A summary of all stock option activity for the nine months ended September 30, 2013 is presented below (dollars in thousands, except per share amounts): | ||||||||||||||||
Shares | Weighted | Weighted | Aggregate | |||||||||||||
Average | Average | Intrinsic | ||||||||||||||
Exercise Price | Remaining Contractual | Value | ||||||||||||||
Term (Years) | ||||||||||||||||
Options outstanding at December 31, 2012 | 18,448,550 | $ | 6.85 | |||||||||||||
Granted | 5,778,323 | $ | 5.38 | |||||||||||||
Exercised | (4,473 | ) | $ | 4.42 | ||||||||||||
Forfeited | (712,885 | ) | $ | 6.42 | ||||||||||||
Options outstanding at September 30, 2013 | 23,509,515 | $ | 6.5 | 4.71 | $ | 5,709 | ||||||||||
Exercisable at September 30, 2013 | 13,803,103 | $ | 7.23 | 3.51 | $ | 2,376 | ||||||||||
As of September 30, 2013, $24.4 million of total unrecognized compensation expense related to employee stock options was expected to be recognized over a weighted-average period of 2.92 years. | ||||||||||||||||
A summary of all restricted stock unit (“RSU”) activity for the nine months ended September 30, 2013 is presented below (dollars in thousands, except per share amounts): | ||||||||||||||||
Shares | Weighted | Weighted | Aggregate | |||||||||||||
Average | Average | Intrinsic | ||||||||||||||
Grant Date | Remaining | Value | ||||||||||||||
Fair Value | Contractual | |||||||||||||||
Term (Years) | ||||||||||||||||
Awards outstanding at December 31, 2012 | 1,294,621 | $ | 6.07 | |||||||||||||
Awarded | 1,058,668 | $ | 5.44 | |||||||||||||
Released | (230,059 | ) | $ | 7.34 | ||||||||||||
Forfeited | (72,132 | ) | $ | 5.48 | ||||||||||||
Awards outstanding at September 30, 2013 | 2,051,098 | $ | 5.62 | 1.98 | $ | 11,855 | ||||||||||
As of September 30, 2013, $8.0 million of total unrecognized compensation expense related to employee RSUs was expected to be recognized over a weighted-average period of 3.33 years. |
Income_Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2013 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | INCOME TAXES |
At December 31, 2012, we had federal net operating loss carry-forwards of approximately $1,007 million which expire in the years 2018 through 2032. We also had net operating loss carry-forwards for California of approximately $880 million, which expire in the years 2013 through 2032, and California tax credits of approximately $26 million. | |
During the three months ended September 30, 2013, Exelixis Bermuda acquired the existing and future intellectual property rights to exploit cabozantinib in jurisdictions outside of the United States. The transfer of the existing rights created a taxable gain in the U.S. and state jurisdictions. For tax purposes, that gain is primarily offset by current fiscal year losses and the remainder through the utilization of an insignificant amount of net operating loss carry-forwards for which there is a corresponding reduction to our valuation allowance. |
Net_Loss_Per_Share
Net Loss Per Share | 9 Months Ended | |||||||||||||||
Sep. 30, 2013 | ||||||||||||||||
Earnings Per Share [Abstract] | ||||||||||||||||
Net Loss Per Share | NET LOSS PER SHARE | |||||||||||||||
The following table sets forth a reconciliation of basic and diluted net loss per share (in thousands, except per share amounts): | ||||||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2013 | 2012 | 2013 | 2012 | |||||||||||||
Numerator: | ||||||||||||||||
Net loss | $ | (67,124 | ) | $ | (32,814 | ) | $ | (174,014 | ) | $ | (95,452 | ) | ||||
Denominator: | ||||||||||||||||
Shares used in computing basic and diluted net loss per share | 184,149 | 166,354 | 183,957 | 152,316 | ||||||||||||
Net loss per share, basic and diluted | $ | (0.36 | ) | $ | (0.20 | ) | $ | (0.95 | ) | $ | (0.63 | ) | ||||
The following table sets forth outstanding potential 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): | ||||||||||||||||
30-Sep | ||||||||||||||||
2013 | 2012 | |||||||||||||||
Convertible debt | 54,123 | 54,123 | ||||||||||||||
Outstanding stock options, unvested RSUs and ESPP contributions | 25,694 | 15,839 | ||||||||||||||
Warrants | 1,441 | 1,441 | ||||||||||||||
Total potentially dilutive shares | 81,258 | 71,403 | ||||||||||||||
Contingencies
Contingencies | 9 Months Ended |
Sep. 30, 2013 | |
Commitments and Contingencies Disclosure [Abstract] | |
Contingencies | CONTINGENCIES |
Pending Litigation | |
From time to time, we are party to legal proceedings, claims and investigations in the ordinary course of business, including the matter described below. | |
In December 2012, a former officer filed a lawsuit against us and our chief executive officer in California state court seeking unspecified monetary damages based on contract and tort claims in connection with the former officer’s execution and revocation of a Rule 10b5-1 stock trading plan in December 2010. This matter was settled for an immaterial amount during the three months ended September 30, 2013. |
Concentrations_of_Credit_Risk
Concentrations of Credit Risk | 9 Months Ended | |||||
Sep. 30, 2013 | ||||||
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. government agency obligations and U.S. government sponsored enterprises. All investments are maintained with financial institutions that management believes are creditworthy. | ||||||
Trade and other receivables are unsecured and are concentrated in the pharmaceutical and biotechnology industries. Accordingly, we may be exposed to credit risk generally associated with pharmaceutical and biotechnology companies. We have incurred no bad debt expense since inception. As of September 30, 2013, 55% of our trade receivables are with the specialty pharmacy that sells COMETRIQ in the United States and 14% are with our European distribution partner. Both of these customers pay promptly and within their respective payment terms. | ||||||
We have operations primarily in the United States, while some of our collaboration partners have headquarters outside of the United States and certain of our clinical trials for cabozantinib are conducted outside of the United States. During the three and nine months ended September 30, 2012, 100% of our revenues were earned in the United States. During the 2013, we initiated a Named Patient Use (“NPU”) program through our distribution partner, Swedish Orphan Biovitrum, to support the distribution and commercialization of COMETRIQ for metastatic MTC primarily in the European Union and potentially other countries. During the three and nine months ended September 30, 2013, 87% and 96%, respectively, of our revenues were earned in the United States; the remainder of our revenues were earned in the European Union under this NPU program. All of our long-lived assets are located in the United States. | ||||||
The following table sets forth the percentage of revenues recognized under our collaboration agreements and product sales to the specialty pharmacy that represent 10% or more of total revenues during the nine months ended September 30, 2013 and 2012: | ||||||
Nine Months Ended September 30, | ||||||
2013 | 2012 | |||||
Collaborator: | ||||||
Bristol-Myers Squibb | 60 | % | 59 | % | ||
Merck | — | % | 27 | % | ||
Daiichi Sankyo | — | % | 14 | % | ||
Pharmacy: | ||||||
Diplomat Specialty Pharmacy | 36 | % | — | % |
Organization_and_Summary_of_Si1
Organization and Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2013 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization | Organization |
Exelixis, Inc. (“Exelixis,” “we,” “our” or “us”) is a biotechnology company committed to developing small molecule therapies for the treatment of cancer. We are focusing our proprietary resources and development and commercialization efforts exclusively on COMETRIQ® (cabozantinib), our wholly-owned inhibitor of multiple receptor tyrosine kinases. On November 29, 2012, the U.S. Food and Drug Administration approved COMETRIQ for the treatment of progressive, metastatic medullary thyroid cancer (“MTC”), in the United States, where it became commercially available in late January 2013. Cabozantinib is being evaluated in a variety of other cancer indications through a broad development program, including two ongoing phase 3 pivotal trials in metastatic castration-resistant prostate cancer, an ongoing phase 3 pivotal trial in metastatic renal cell cancer and an ongoing phase 3 pivotal trial in advanced hepatocellular cancer. We believe COMETRIQ has the potential to be a high-quality, broadly-active and differentiated anti-cancer agent that can make a meaningful difference in the lives of patients. Our objective is to develop COMETRIQ into a major oncology franchise, and we believe that the approval of COMETRIQ for the treatment of progressive, metastatic MTC provides us with the opportunity to establish a commercial presence in furtherance of this objective. | |
We have also established a portfolio of other novel compounds that we believe have the potential to address serious unmet medical needs. Many of these compounds are being developed by partners as part of collaborations, at no cost to us but with significant retained economics to us in the event these compounds are commercialized. As disclosed on ClinicalTrials.gov (NCT01689519), a phase 3 clinical trial for one of these compounds, cobimetinib (GDC-0973/XL518), which we out-licensed to Genentech, Inc. (a wholly-owned member of the Roche Group), was initiated on November 1, 2012. | |
Basis of Consolidation | Basis of Consolidation |
The consolidated financial statements include the accounts of Exelixis and those of our wholly-owned subsidiaries, including Exelixis International (Bermuda) Ltd. (“Exelixis Bermuda”). In September 2013, Exelixis engaged in intercompany transactions whereby Exelixis Bermuda acquired the existing and future intellectual property rights to exploit cabozantinib in jurisdictions outside of the United States. All intercompany balances and transactions have been eliminated. | |
Basis of Presentation | Basis of Presentation |
The accompanying unaudited consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States for interim financial information and pursuant to Form 10-Q and Article 10 of Regulation S-X of the Securities and Exchange Commission (“SEC”). Accordingly, they do not include all of the information and footnotes required by U.S. generally accepted accounting principles for complete financial statements. In our opinion, all adjustments (consisting only of normal recurring adjustments) considered necessary for a fair presentation of the results of operations and cash flows for the period presented have been included. | |
Exelixis adopted a 52- or 53-week fiscal year that generally ends on the Friday closest to December 31st. Fiscal year 2012, a 52-week year, ended on December 28, 2012, and fiscal year 2013, a 52-week year, will end on December 27, 2013. For convenience, references in this report as of and for the fiscal quarters ended September 28, 2012 and September 27, 2013, and as of the fiscal year ended December 28, 2012, are indicated as ended September 30, 2012, September 30, 2013, and December 31, 2012, respectively. | |
Operating results for the three and nine months ended September 30, 2013 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2013 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 fiscal year ended December 31, 2012, included in our Annual Report on Form 10-K filed with the SEC on February 21, 2013. | |
Fiscal Period, Policy | Exelixis adopted a 52- or 53-week fiscal year that generally ends on the Friday closest to December 31st. |
Use of Estimates | Use of Estimates |
The preparation of the consolidated financial statements is in conformity with accounting principles generally accepted in the United States which requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosures. On an ongoing basis, management evaluates its estimates including, but not limited to, those related to inventory, revenue recognition, cost of goods sold, valuation of long-lived assets, certain accrued liabilities including clinical trial accruals and restructuring liability, share-based compensation and the valuation of the debt and equity components of our convertible debt at issuance. We base our estimates on historical experience and on various other market-specific and other relevant assumptions that are believed 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. | |
Inventory | Inventory |
We consider regulatory approval of product candidates to be uncertain and product manufactured prior to regulatory approval may not be sold unless regulatory approval is obtained. As such, the manufacturing costs for product candidates incurred prior to regulatory approval are not capitalized as inventory but rather are expensed as research and development costs. When regulatory approval is obtained, we begin capitalization of inventory related costs. We received regulatory approval for our first product, COMETRIQ, on November 29, 2012. | |
Inventory is valued at the lower of cost or net realizable value. We determine the cost of inventory using the standard-cost method, which approximates actual cost based on a first-in, first-out method. We analyze our inventory levels quarterly and write down inventory that has become obsolete, or has a cost basis in excess of its expected net realizable value and inventory quantities in excess of expected requirements. Expired inventory is disposed of and the related costs are recognized as cost of goods sold in the Consolidated Statements of Operations. | |
Goodwill and Intangible Assets, Policy [Policy Text Block] | Goodwill |
Goodwill amounts have been recorded as the excess purchase price over tangible assets, liabilities and intangible assets acquired based on their estimated fair value, by applying the purchase method. Goodwill is not subject to amortization. We evaluate goodwill for impairment on an annual basis and on an interim basis if events or changes in circumstances between annual impairment tests indicate that the asset might be impaired. When evaluating goodwill for impairment we must determine the reporting units that exist within Exelixis. We have determined that we have one reporting unit, which is consistent with our sole operating segment as of September 30, 2013 and December 31, 2012. | |
Revenue Recognition | Revenue Recognition |
We recognize revenue from the sale of COMETRIQ and from license fees and milestones earned on research and collaboration 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, 2012 for a description of our policies for revenue recognition on research and collaboration agreements. We did not enter into any new collaboration agreements during the nine months ended September 30, 2013. 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, 2012 for a description of our existing collaboration agreements. | |
Net Product Revenues | |
We recognize revenue when it is both realized or realizable and earned, meaning persuasive evidence of an arrangement exists, delivery has occurred, title has transferred, the price is fixed or determinable, there are no remaining customer acceptance requirements, and collectability of the resulting receivable is reasonably assured. For product sales in the United States, this generally occurs upon shipment of the product to the patient. For product sales in Europe, this occurs when our European distribution partner has accepted the product. | |
We sell our product, COMETRIQ, in the United States to a specialty pharmacy that benefits from customer incentives and has a right of return. We have a limited sales history and cannot reliably estimate expected returns of the product nor the discounts and rebates due to payors at the time of shipment to the specialty pharmacy. Accordingly, upon shipment to the specialty pharmacy, we record deferred revenue on our Consolidated Balance Sheets. We recognize revenue when the specialty pharmacy provides the product to a patient based on the fulfillment of a prescription. We record revenue using an analysis of prescription data from our specialty pharmacy to ascertain the date of shipment and the payor mix. This approach is frequently referred to as the “sell-through” revenue recognition model. Once the prescription has been provided to the patient, it is not subject to return unless the product is damaged. | |
Product sales to our European distribution partner are not subject to customer incentives, rights of return or discounts and allowances. We record revenue at the time our European distribution partner has accepted the product, a method also known as the “sell-in” revenue recognition model. | |
Product Sales Discounts and Allowances | |
We calculate gross product revenues based on the price that we charge our United States specialty pharmacy and our European distribution partner. We estimate our net product revenues by deducting from our gross product revenues (a) trade allowances, such as discounts for prompt payment, (b) estimated government rebates and chargebacks, and (c) estimated costs of patient assistance programs. We initially record estimates for these deductions at the time we recognize the gross revenue. We update our estimates on a recurring basis as new information becomes available. These discounts and allowances apply only to gross product revenues earned in the United States. | |
Customer Credits: The United States specialty pharmacy receives a discount of 2% for prompt payment. We expect this specialty pharmacy will earn 100% of its prompt payment discounts and, therefore, we deduct the full amount of these discounts from total product sales when revenues are recognized. | |
Mandated Rebates: Allowances for rebates include mandated discounts under the Medicaid Drug Rebate Program and other government programs. Rebate amounts owed after the final dispensing of the product to a benefit plan participant are based upon contractual agreements or legal requirements with public sector benefit providers, such as Medicaid. The allowance for rebates is based on statutory discount rates and expected utilization. Our estimates for the expected utilization of rebates are based on customer and payor data received from the United States specialty pharmacy. Rebates are generally invoiced by the payor and paid in arrears, such that the accrual balance consists of an estimate of the amount expected to be incurred for the current quarter’s shipments to patients, plus an accrual balance for known prior quarter’s unpaid rebates. If actual future rebates vary from estimates, we may need to adjust our accruals, which would affect net revenue in the period of adjustment. | |
Chargebacks: Chargebacks are discounts that occur when contracted customers purchase directly from a specialty pharmacy. Contracted customers, which currently consist primarily of Public Health Service institutions, non-profit clinics, and Federal government entities purchasing via the Federal Supply Schedule, generally purchase the product at a discounted price. The United States specialty pharmacy, in turn, charges back to us the difference between the price initially paid by the specialty pharmacy and the discounted price paid to the specialty pharmacy by the customer. The allowance for chargebacks is based on sales to contracted customers. | |
Medicare Part D Coverage Gap: In the United States, the Medicare Part D prescription drug benefit mandates manufacturers to fund 50% of the Medicare Part D insurance coverage gap for prescription drugs sold to eligible patients. Our estimates for expected Medicare Part D coverage gap are based in part on third party market research data and on customer and payor data received from the United States specialty pharmacy. Funding of the coverage gap is invoiced and paid in arrears so that the accrual balance consists of an estimate of the amount expected to be incurred for the current quarter's shipments to patients, plus an accrual balance for prior sales. If actual future funding varies from estimates, we may need to adjust our accruals, which would affect net revenue in the period of adjustment. | |
Co-payment Assistance: Patients who have commercial insurance and meet certain eligibility requirements may receive co-payment assistance. We accrue a liability for co-payment assistance based on actual program participation and estimates of program redemption using customer data provided by our United States specialty pharmacy. | |
Patient Assistance Program | |
We provide COMETRIQ at no cost to eligible patients who have no insurance and meet certain financial and clinical criteria through our Patient Assistance Program (“PAP”). We record the cost of the product as a selling, general and administrative expense at the time the product is designated as PAP inventory. | |
Cost of Goods Sold | Cost of Goods Sold |
Cost of goods sold is related to our product revenues and consists primarily a 3% royalty we are required to pay GlaxoSmithKline and indirect labor costs. A significant portion of the manufacturing costs for current product sales were incurred prior to regulatory approval of COMETRIQ for the treatment of progressive, metastatic MTC and, therefore, were expensed as research and development costs when incurred, rather than capitalized as inventory. | |
In accordance with our 2002 collaboration agreement with GlaxoSmithKline, we are required to pay GlaxoSmithKline a 3% royalty on the Net Sales of any product incorporating cabozantinib, including COMETRIQ. Net Sales is defined in the collaboration agreement generally as the gross invoiced sales price less customer credits, rebates, chargebacks, shipping costs, customs duties, and sales tax and other similar tax payments we are required to make. | |
Recently Adopted Accounting Pronouncements | Recently Adopted Accounting Pronouncements |
In February 2013, Accounting Standards Codification Topic 220, Comprehensive Income was amended to require additional information about amounts reclassified out of accumulated other comprehensive income. We adopted this guidance beginning January 1, 2013, and will provide the additional information when such reclassifications occur. The amendment did not have a material effect on our consolidated financial statements. | |
Segment Reporting, Policy [Policy Text Block] | Segment Information |
We operate in one business segment. |
Restructurings_Tables
Restructurings (Tables) | 9 Months Ended | |||||||||||||||||||
Sep. 30, 2013 | ||||||||||||||||||||
Restructuring Charges [Abstract] | ||||||||||||||||||||
Summary Of Components Of Restructuring Liability | The components and changes of these liabilities during the annual periods from inception of the restructuring activities through the year ended December 31, 2012 and during the nine months ended September 30, 2013 are summarized in the following table (in thousands): | |||||||||||||||||||
Employee | Facility | Asset | Legal and | Total | ||||||||||||||||
Severance | Charges | Impairment | Other Fees | |||||||||||||||||
and Other Benefits | ||||||||||||||||||||
Restructuring liability as of December 31, 2011 | $ | 6 | $ | 13,921 | $ | — | $ | 51 | $ | 13,978 | ||||||||||
Restructuring charge (credit) | 970 | 8,276 | (47 | ) | (28 | ) | 9,171 | |||||||||||||
Cash payments | (965 | ) | (5,299 | ) | — | (3 | ) | (6,267 | ) | |||||||||||
Adjustments or non-cash credits including stock compensation expense | (11 | ) | 2,304 | (891 | ) | — | 1,402 | |||||||||||||
Proceeds from sale of assets | — | — | 938 | — | 938 | |||||||||||||||
Restructuring liability as of December 31, 2012 | — | 19,202 | — | 20 | 19,222 | |||||||||||||||
Restructuring charge (credit) | 496 | 359 | 25 | (15 | ) | 865 | ||||||||||||||
Cash payments | (424 | ) | (5,608 | ) | — | — | (6,032 | ) | ||||||||||||
Adjustments or non-cash credits including stock compensation expense | (55 | ) | (73 | ) | (25 | ) | — | (153 | ) | |||||||||||
Restructuring liability as of | $ | 17 | $ | 13,880 | $ | — | $ | 5 | $ | 13,902 | ||||||||||
30-Sep-13 | ||||||||||||||||||||
Cash_and_Investments_Cash_and_
Cash and Investments Cash and Investments (Tables) | 9 Months Ended | |||||||||||||||
Sep. 30, 2013 | ||||||||||||||||
Investments, Debt and Equity Securities [Abstract] | ||||||||||||||||
Schedule of Available-for-Sale Securities | The following table summarizes cash and cash equivalents, investments, and restricted cash and investments by balance sheet line item as of September 30, 2013 and December 31, 2012 (in thousands): | |||||||||||||||
September 30, 2013 | ||||||||||||||||
Amortized | Gross | Gross | Fair Value | |||||||||||||
Cost | Unrealized | Unrealized | ||||||||||||||
Gains | Losses | |||||||||||||||
As reported: | ||||||||||||||||
Cash and cash equivalents | $ | 92,016 | $ | — | $ | — | $ | 92,016 | ||||||||
Short-term investments | 187,086 | 141 | (24 | ) | 187,203 | |||||||||||
Short-term restricted cash and investments | 12,172 | 39 | — | 12,211 | ||||||||||||
Long-term investments | 157,437 | 63 | (98 | ) | 157,402 | |||||||||||
Long-term restricted cash and investments | 15,830 | 59 | — | 15,889 | ||||||||||||
Total cash and investments | $ | 464,541 | $ | 302 | $ | (122 | ) | $ | 464,721 | |||||||
December 31, 2012 | ||||||||||||||||
Amortized | Gross | Gross | Fair Value | |||||||||||||
Cost | Unrealized | Unrealized | ||||||||||||||
Gains | Losses | |||||||||||||||
As reported: | ||||||||||||||||
Cash and cash equivalents | $ | 170,070 | $ | — | $ | (1 | ) | $ | 170,069 | |||||||
Short-term investments | 241,391 | 46 | (66 | ) | 241,371 | |||||||||||
Short-term restricted cash and investments | 12,242 | 4 | — | 12,246 | ||||||||||||
Long-term investments | 182,407 | 28 | (124 | ) | 182,311 | |||||||||||
Long-term restricted cash and investments | 27,943 | 21 | — | 27,964 | ||||||||||||
Total cash and investments | $ | 634,053 | $ | 99 | $ | (191 | ) | $ | 633,961 | |||||||
Summary of Cash and Investments by Security Type | The following table summarizes our cash and cash equivalents and investments by security type as of September 30, 2013 and December 31, 2012 (in thousands): | |||||||||||||||
September 30, 2013 | ||||||||||||||||
Amortized | Gross | Gross | Fair Value | |||||||||||||
Cost | Unrealized | Unrealized | ||||||||||||||
Gains | Losses | |||||||||||||||
Cash and money market funds | $ | 62,645 | $ | — | $ | — | $ | 62,645 | ||||||||
Commercial paper | 43,591 | 1 | — | 43,592 | ||||||||||||
Corporate bonds | 266,700 | 173 | (122 | ) | 266,751 | |||||||||||
U.S. Treasury and government sponsored enterprises | 83,323 | 119 | — | 83,442 | ||||||||||||
Municipal bonds | 8,282 | 9 | — | 8,291 | ||||||||||||
Total cash and investments | $ | 464,541 | $ | 302 | $ | (122 | ) | $ | 464,721 | |||||||
December 31, 2012 | ||||||||||||||||
Amortized | Gross | Gross | Fair Value | |||||||||||||
Cost | Unrealized | Unrealized | ||||||||||||||
Gains | Losses | |||||||||||||||
Cash and money market funds | $ | 81,744 | $ | 2 | $ | — | $ | 81,746 | ||||||||
Commercial paper | 167,223 | 8 | — | 167,231 | ||||||||||||
Corporate bonds | 222,106 | 30 | (187 | ) | 221,949 | |||||||||||
U.S. Treasury and government sponsored enterprises | 132,933 | 59 | (1 | ) | 132,991 | |||||||||||
Municipal bonds | 30,047 | — | (3 | ) | 30,044 | |||||||||||
Total cash and investments | $ | 634,053 | $ | 99 | $ | (191 | ) | $ | 633,961 | |||||||
Summary of Available-for-Sale Securities by Contractual Maturity | The following summarizes the fair value of securities classified as available-for-sale by contractual maturity as of September 30, 2013 (in thousands): | |||||||||||||||
Mature within One Year | After One Year through Two Years | Fair Value | ||||||||||||||
Money market funds | $ | 58,102 | $ | — | $ | 58,102 | ||||||||||
Commercial paper | 43,592 | — | 43,592 | |||||||||||||
Corporate bonds | 168,715 | 98,036 | 266,751 | |||||||||||||
U.S. Treasury and government sponsored enterprises | 71,279 | 12,163 | 83,442 | |||||||||||||
Municipal bonds | 2,212 | 6,079 | 8,291 | |||||||||||||
Total | $ | 343,900 | $ | 116,278 | $ | 460,178 | ||||||||||
Inventory_Tables
Inventory (Tables) | 9 Months Ended | |||||||
Sep. 30, 2013 | ||||||||
Inventory Disclosure [Abstract] | ||||||||
Schedule of Inventory | Inventory consists of the following (in thousands): | |||||||
September 30, | December 31, | |||||||
2013 | 2012 | |||||||
Raw materials | $ | 301 | $ | — | ||||
Work in process | 1,374 | — | ||||||
Finished goods | 89 | — | ||||||
Total | $ | 1,764 | $ | — | ||||
Debt_Tables
Debt (Tables) | 9 Months Ended | |||||||
Sep. 30, 2013 | ||||||||
Debt Disclosure [Abstract] | ||||||||
Schedule Of Debt | The amortized carrying amount of our debt consists of the following (in thousands): | |||||||
September 30, | December 31, | |||||||
2013 | 2012 | |||||||
Convertible Senior Subordinated Notes due 2019 | $ | 161,279 | $ | 149,800 | ||||
Secured Convertible Notes due 2015 | 97,428 | 100,676 | ||||||
Silicon Valley Bank term loan | 80,000 | 80,000 | ||||||
Silicon Valley Bank line of credit | 2,884 | 5,260 | ||||||
Total debt | 341,591 | 335,736 | ||||||
Less: current portion | (12,127 | ) | (13,170 | ) | ||||
Long-term debt | $ | 329,464 | $ | 322,566 | ||||
Summary Of The Liability Component Of The 2019 Notes | The following is a summary of the liability component of the 2019 Notes as of September 30, 2013 (in thousands): | |||||||
September 30, | ||||||||
2013 | ||||||||
Net carrying amount of the liability component | $ | 161,279 | ||||||
Unamortized discount of the liability component | 126,221 | |||||||
Face amount of the 2019 Notes | $ | 287,500 | ||||||
Fair_Value_Measurements_Fair_V
Fair Value Measurements Fair Value Measurements (Tables) | 9 Months Ended | |||||||||||||||
Sep. 30, 2013 | ||||||||||||||||
Fair Value Disclosures [Abstract] | ||||||||||||||||
Schedule Of Fair Value Of Financial Assets Measured On A Recurring Basis | The amounts presented exclude cash, but include investments classified as cash equivalents (in thousands): | |||||||||||||||
September 30, 2013 | ||||||||||||||||
Level 1 | Level 2 | Total | ||||||||||||||
Money market funds | $ | 58,102 | $ | — | $ | 58,102 | ||||||||||
Commercial paper | — | 43,592 | 43,592 | |||||||||||||
Corporate bonds | — | 266,751 | 266,751 | |||||||||||||
U.S. Treasury and government sponsored enterprises | — | 83,442 | 83,442 | |||||||||||||
Municipal bonds | — | 8,291 | 8,291 | |||||||||||||
Total | $ | 58,102 | $ | 402,076 | $ | 460,178 | ||||||||||
December 31, 2012 | ||||||||||||||||
Level 1 | Level 2 | Total | ||||||||||||||
Money market funds | $ | 76,050 | $ | — | $ | 76,050 | ||||||||||
Commercial paper | — | 167,231 | 167,231 | |||||||||||||
Corporate bonds | — | 221,949 | 221,949 | |||||||||||||
U.S. Treasury and government sponsored enterprises | — | 132,991 | 132,991 | |||||||||||||
Municipal bonds | — | 30,044 | 30,044 | |||||||||||||
Total | $ | 76,050 | $ | 552,215 | $ | 628,265 | ||||||||||
Schedule Of Estimated Fair Value Of Outstanding Debt | The estimated fair values of our financial instruments that are carried at amortized cost for which it is practicable to determine a fair value were as follows (in thousands): | |||||||||||||||
September 30, 2013 | December 31, 2012 | |||||||||||||||
Carrying | Fair Value | Carrying | Fair Value | |||||||||||||
Amount | Amount | |||||||||||||||
2019 Notes | $ | 161,279 | $ | 337,928 | $ | 149,800 | $ | 280,111 | ||||||||
Silicon Valley Bank term loan | $ | 80,000 | $ | 79,884 | $ | 80,000 | $ | 79,542 | ||||||||
Silicon Valley Bank Line of Credit | $ | 2,884 | $ | 2,884 | $ | 5,260 | $ | 5,253 | ||||||||
StockBased_Compensation_Tables
Stock-Based Compensation (Tables) | 9 Months Ended | |||||||||||||||
Sep. 30, 2013 | ||||||||||||||||
Share-based Compensation [Abstract] | ||||||||||||||||
Schedule Of Allocated Employee Stock-Based Compensation Expenses | We recorded and allocated employee stock-based compensation expenses for our equity incentive plans and our 2000 Employee Stock Purchase Plan (“ESPP”) as follows (in thousands): | |||||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2013 | 2012 | 2013 | 2012 | |||||||||||||
Research and development expense | $ | 1,415 | $ | 970 | $ | 4,326 | $ | 3,202 | ||||||||
Selling, general and administrative expense | 1,478 | 923 | 4,115 | 2,970 | ||||||||||||
Restructuring-related stock-based compensation expense | — | — | 49 | — | ||||||||||||
Total employee stock-based compensation expense | $ | 2,893 | $ | 1,893 | $ | 8,490 | $ | 6,172 | ||||||||
Schedule Of Fair Value Of Employee Share-Based Payments Awards Estimated Using The Assumptions And Weighted Average Fair Values | The fair value of employee stock option awards and ESPP purchases was estimated using the following assumptions and weighted average fair values: | |||||||||||||||
Stock Options | ||||||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2013 | 2012 | 2013 | 2012 | |||||||||||||
Weighted average grant-date fair value | $ | 2.99 | $ | 3.31 | $ | 2.92 | $ | 3.27 | ||||||||
Risk-free interest rate | 1.57 | % | 0.81 | % | 1.47 | % | 0.82 | % | ||||||||
Dividend yield | — | % | — | % | — | % | — | % | ||||||||
Volatility | 60 | % | 69 | % | 60 | % | 69 | % | ||||||||
Expected life | 5.6 years | 5.6 years | 5.6 years | 5.7 years | ||||||||||||
Employee Stock Purchase Plan | ||||||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2013 | 2012 | 2013 | 2012 | |||||||||||||
Weighted average grant-date fair value | $ | 1.74 | $ | 1.63 | $ | 1.66 | $ | 2.13 | ||||||||
Risk-free interest rate | 0.08 | % | 0.15 | % | 0.12 | % | 0.1 | % | ||||||||
Dividend yield | — | % | — | % | — | % | — | % | ||||||||
Volatility | 67 | % | 68 | % | 67 | % | 68 | % | ||||||||
Expected life | 0.5 years | 0.5 years | 0.5 years | 0.5 years | ||||||||||||
Summary Of All Stock Option Activity | A summary of all stock option activity for the nine months ended September 30, 2013 is presented below (dollars in thousands, except per share amounts): | |||||||||||||||
Shares | Weighted | Weighted | Aggregate | |||||||||||||
Average | Average | Intrinsic | ||||||||||||||
Exercise Price | Remaining Contractual | Value | ||||||||||||||
Term (Years) | ||||||||||||||||
Options outstanding at December 31, 2012 | 18,448,550 | $ | 6.85 | |||||||||||||
Granted | 5,778,323 | $ | 5.38 | |||||||||||||
Exercised | (4,473 | ) | $ | 4.42 | ||||||||||||
Forfeited | (712,885 | ) | $ | 6.42 | ||||||||||||
Options outstanding at September 30, 2013 | 23,509,515 | $ | 6.5 | 4.71 | $ | 5,709 | ||||||||||
Exercisable at September 30, 2013 | 13,803,103 | $ | 7.23 | 3.51 | $ | 2,376 | ||||||||||
Summary Of All RSU Activity | A summary of all restricted stock unit (“RSU”) activity for the nine months ended September 30, 2013 is presented below (dollars in thousands, except per share amounts): | |||||||||||||||
Shares | Weighted | Weighted | Aggregate | |||||||||||||
Average | Average | Intrinsic | ||||||||||||||
Grant Date | Remaining | Value | ||||||||||||||
Fair Value | Contractual | |||||||||||||||
Term (Years) | ||||||||||||||||
Awards outstanding at December 31, 2012 | 1,294,621 | $ | 6.07 | |||||||||||||
Awarded | 1,058,668 | $ | 5.44 | |||||||||||||
Released | (230,059 | ) | $ | 7.34 | ||||||||||||
Forfeited | (72,132 | ) | $ | 5.48 | ||||||||||||
Awards outstanding at September 30, 2013 | 2,051,098 | $ | 5.62 | 1.98 | $ | 11,855 | ||||||||||
Net_Loss_Per_Share_Tables
Net Loss Per Share (Tables) | 9 Months Ended | |||||||||||||||
Sep. 30, 2013 | ||||||||||||||||
Earnings Per Share [Abstract] | ||||||||||||||||
Schedule Of Reconciliation Of Basic And Diluted Net Income (Loss) Per Share | The following table sets forth a reconciliation of basic and diluted net loss per share (in thousands, except per share amounts): | |||||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2013 | 2012 | 2013 | 2012 | |||||||||||||
Numerator: | ||||||||||||||||
Net loss | $ | (67,124 | ) | $ | (32,814 | ) | $ | (174,014 | ) | $ | (95,452 | ) | ||||
Denominator: | ||||||||||||||||
Shares used in computing basic and diluted net loss per share | 184,149 | 166,354 | 183,957 | 152,316 | ||||||||||||
Net loss per share, basic and diluted | $ | (0.36 | ) | $ | (0.20 | ) | $ | (0.95 | ) | $ | (0.63 | ) | ||||
Schedule Of Potential Shares Of Common Stock Not Included In Computation Of Diluted Net Loss Per Share | The following table sets forth outstanding potential 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): | |||||||||||||||
30-Sep | ||||||||||||||||
2013 | 2012 | |||||||||||||||
Convertible debt | 54,123 | 54,123 | ||||||||||||||
Outstanding stock options, unvested RSUs and ESPP contributions | 25,694 | 15,839 | ||||||||||||||
Warrants | 1,441 | 1,441 | ||||||||||||||
Total potentially dilutive shares | 81,258 | 71,403 | ||||||||||||||
Concentrations_of_Credit_Risk_
Concentrations of Credit Risk (Tables) | 9 Months Ended | |||||
Sep. 30, 2013 | ||||||
Risks and Uncertainties [Abstract] | ||||||
Schedules of collaborators that represent 10% or more of total revenues | The following table sets forth the percentage of revenues recognized under our collaboration agreements and product sales to the specialty pharmacy that represent 10% or more of total revenues during the nine months ended September 30, 2013 and 2012: | |||||
Nine Months Ended September 30, | ||||||
2013 | 2012 | |||||
Collaborator: | ||||||
Bristol-Myers Squibb | 60 | % | 59 | % | ||
Merck | — | % | 27 | % | ||
Daiichi Sankyo | — | % | 14 | % | ||
Pharmacy: | ||||||
Diplomat Specialty Pharmacy | 36 | % | — | % |
Organization_and_Summary_of_Si2
Organization and Summary of Significant Accounting Policies (Details) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2013 | Dec. 31, 2012 | |
segment | ||
phase | ||
Operations [Line Items] | ||
Number of Phases in Process | 2 | |
Annual Operating Cycle | P52W | P52W |
Number of Operating Segments | 1 | |
Sales Revenue, Percent Discount for Prompt Payment | 2.00% | |
Glaxo Smith Kline [Member] | ||
Operations [Line Items] | ||
Percent of royalty on net sale | 3.00% | |
Minimum [Member] | ||
Operations [Line Items] | ||
Annual Operating Cycle | P52W | |
Maximum [Member] | ||
Operations [Line Items] | ||
Annual Operating Cycle | P53W |
Restructurings_Narrative_Detai
Restructurings (Narrative) (Details) (USD $) | 3 Months Ended | 9 Months Ended | 12 Months Ended | 45 Months Ended | |||
Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | Dec. 31, 2012 | Sep. 30, 2013 | Dec. 31, 2011 | |
employee | employee | employee | |||||
Restructuring Cost and Reserve [Line Items] | |||||||
Aggregate reduction in headcount | 429 | 429 | 429 | ||||
Restructuring charge (credit) | $137,000 | $733,000 | $865,000 | $1,704,000 | $9,171,000 | $52,900,000 | |
Proceeds from sale of property and equipment | 40,000 | 877,000 | 938,000 | ||||
Restructuring Reserve | 13,902,000 | 13,902,000 | 19,222,000 | 13,902,000 | 13,978,000 | ||
Expected additional payment for restructuring | 1,800,000 | ||||||
Restructuring Reserve, Settled with Cash | 6,032,000 | 6,267,000 | 34,800,000 | ||||
Proceeds from Subtenants | 9,100,000 | ||||||
Total Restructuring [Member] | |||||||
Restructuring Cost and Reserve [Line Items] | |||||||
Restructuring Reserve, Cash Settlement Net of Proceeds | 2,100,000 | 2,200,000 | 6,000,000 | 4,500,000 | |||
Credit for New Sublease [Member] | |||||||
Restructuring Cost and Reserve [Line Items] | |||||||
Restructuring charge (credit) | 700,000 | ||||||
Facility Closing [Member] | |||||||
Restructuring Cost and Reserve [Line Items] | |||||||
Restructuring charge (credit) | 359,000 | 8,276,000 | 28,900,000 | ||||
Proceeds from sale of property and equipment | 0 | ||||||
Restructuring Reserve | 13,880,000 | 13,880,000 | 19,202,000 | 13,880,000 | 13,921,000 | ||
Restructuring Reserve, Settled with Cash | 5,608,000 | 5,299,000 | |||||
Termination Benefits [Member] | |||||||
Restructuring Cost and Reserve [Line Items] | |||||||
Restructuring charge (credit) | 496,000 | 970,000 | 21,700,000 | ||||
Proceeds from sale of property and equipment | 0 | ||||||
Restructuring Reserve | 17,000 | 17,000 | 0 | 17,000 | 6,000 | ||
Restructuring Reserve, Settled with Cash | 424,000 | 965,000 | |||||
Asset Impairment [Member] | |||||||
Restructuring Cost and Reserve [Line Items] | |||||||
Restructuring charge (credit) | 25,000 | -47,000 | 2,200,000 | ||||
Proceeds from sale of property and equipment | 938,000 | 2,600,000 | |||||
Restructuring Reserve | 0 | 0 | 0 | 0 | 0 | ||
Restructuring Reserve, Settled with Cash | $0 | $0 |
Restructurings_Summary_of_Comp
Restructurings (Summary of Components of Restructuring Liability) (Details) (USD $) | 3 Months Ended | 9 Months Ended | 12 Months Ended | 45 Months Ended | ||
In Thousands, unless otherwise specified | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | Dec. 31, 2012 | Sep. 30, 2013 |
Restructuring Reserve [Roll Forward] | ||||||
Restructuring liability | $19,222 | $13,978 | $13,978 | |||
Restructuring charge (credit) | 137 | 733 | 865 | 1,704 | 9,171 | 52,900 |
Cash payments | -6,032 | -6,267 | -34,800 | |||
Adjustments or non-cash credits including stock compensation expense | -153 | 1,402 | ||||
Proceeds from sale of assets | 40 | 877 | 938 | |||
Restructuring liability | 13,902 | 13,902 | 19,222 | 13,902 | ||
Employee Severance And Other Benefits [Member] | ||||||
Restructuring Reserve [Roll Forward] | ||||||
Restructuring liability | 0 | 6 | 6 | |||
Restructuring charge (credit) | 496 | 970 | 21,700 | |||
Cash payments | -424 | -965 | ||||
Adjustments or non-cash credits including stock compensation expense | -55 | -11 | ||||
Proceeds from sale of assets | 0 | |||||
Restructuring liability | 17 | 17 | 0 | 17 | ||
Facility Charges [Member] | ||||||
Restructuring Reserve [Roll Forward] | ||||||
Restructuring liability | 19,202 | 13,921 | 13,921 | |||
Restructuring charge (credit) | 359 | 8,276 | 28,900 | |||
Cash payments | -5,608 | -5,299 | ||||
Adjustments or non-cash credits including stock compensation expense | -73 | 2,304 | ||||
Proceeds from sale of assets | 0 | |||||
Restructuring liability | 13,880 | 13,880 | 19,202 | 13,880 | ||
Asset Impairment [Member] | ||||||
Restructuring Reserve [Roll Forward] | ||||||
Restructuring liability | 0 | 0 | 0 | |||
Restructuring charge (credit) | 25 | -47 | 2,200 | |||
Cash payments | 0 | 0 | ||||
Adjustments or non-cash credits including stock compensation expense | -25 | -891 | ||||
Proceeds from sale of assets | 938 | 2,600 | ||||
Restructuring liability | 0 | 0 | 0 | 0 | ||
Credit for New Sublease [Member] | ||||||
Restructuring Reserve [Roll Forward] | ||||||
Restructuring charge (credit) | 700 | |||||
Legal And Other Fees [Member] | ||||||
Restructuring Reserve [Roll Forward] | ||||||
Restructuring liability | 20 | 51 | 51 | |||
Restructuring charge (credit) | -15 | -28 | ||||
Cash payments | 0 | -3 | ||||
Adjustments or non-cash credits including stock compensation expense | 0 | 0 | ||||
Proceeds from sale of assets | 0 | |||||
Restructuring liability | $5 | $5 | $20 | $5 |
Cash_and_Investments_Cash_and_1
Cash and Investments Cash and Investments (Details) (USD $) | 9 Months Ended | |
Sep. 30, 2013 | Dec. 31, 2012 | |
investment | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | $464,541,000 | $634,053,000 |
Gross Unrealized Gains | 302,000 | 99,000 |
Gross Unrealized Losses | -122,000 | -191,000 |
Fair Value | 464,721,000 | 633,961,000 |
Unrealized loss position | 106,800,000 | |
Number of investments in an unrealized loss position | 53 | |
Unrealized loss position of all securities in years | 1 year | |
Silicon Valley Bank Loan And Security Agreement [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Collateral balance | 84,500,000 | 87,000,000 |
Cash and cash equivalents [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 92,016,000 | 170,070,000 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | -1,000 |
Fair Value | 92,016,000 | 170,069,000 |
Short-term investments [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 187,086,000 | 241,391,000 |
Gross Unrealized Gains | 141,000 | 46,000 |
Gross Unrealized Losses | -24,000 | -66,000 |
Fair Value | 187,203,000 | 241,371,000 |
Short-term restricted cash and investments [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 12,172,000 | 12,242,000 |
Gross Unrealized Gains | 39,000 | 4,000 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | 12,211,000 | 12,246,000 |
Long-term investments [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 157,437,000 | 182,407,000 |
Gross Unrealized Gains | 63,000 | 28,000 |
Gross Unrealized Losses | -98,000 | -124,000 |
Fair Value | 157,402,000 | 182,311,000 |
Long-term restricted cash and investments [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 15,830,000 | 27,943,000 |
Gross Unrealized Gains | 59,000 | 21,000 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | 15,889,000 | 27,964,000 |
Cash and money market funds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 62,645,000 | 81,744,000 |
Gross Unrealized Gains | 0 | 2,000 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | 62,645,000 | 81,746,000 |
Money market funds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Fair Value | 58,102,000 | |
Mature within One Year | 58,102,000 | |
After One Year through Two Years | 0 | |
Commercial paper [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 43,591,000 | 167,223,000 |
Gross Unrealized Gains | 1,000 | 8,000 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | 43,592,000 | 167,231,000 |
Mature within One Year | 43,592,000 | |
After One Year through Two Years | 0 | |
Corporate bonds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 266,700,000 | 222,106,000 |
Gross Unrealized Gains | 173,000 | 30,000 |
Gross Unrealized Losses | -122,000 | -187,000 |
Fair Value | 266,751,000 | 221,949,000 |
Unrealized loss position | 105,800,000 | |
Mature within One Year | 168,715,000 | |
After One Year through Two Years | 98,036,000 | |
U.S. Treasury and government sponsored enterprises [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 83,323,000 | 132,933,000 |
Gross Unrealized Gains | 119,000 | 59,000 |
Gross Unrealized Losses | 0 | -1,000 |
Fair Value | 83,442,000 | 132,991,000 |
Mature within One Year | 71,279,000 | |
After One Year through Two Years | 12,163,000 | |
Municipal bonds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 8,282,000 | 30,047,000 |
Gross Unrealized Gains | 9,000 | 0 |
Gross Unrealized Losses | 0 | -3,000 |
Fair Value | 8,291,000 | 30,044,000 |
Mature within One Year | 2,212,000 | |
After One Year through Two Years | 6,079,000 | |
Investments, excluding cash [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Fair Value | 460,178,000 | |
Mature within One Year | 343,900,000 | |
After One Year through Two Years | $116,278,000 |
Inventory_Details
Inventory (Details) (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
In Thousands, unless otherwise specified | ||
Inventory Disclosure [Abstract] | ||
Raw materials | $301 | $0 |
Work in process | 1,374 | 0 |
Finished goods | 89 | 0 |
Total | $1,764 | $0 |
Debt_Narrative_Details
Debt (Narrative) (Details) (USD $) | 3 Months Ended | 9 Months Ended | 3 Months Ended | 9 Months Ended | |||||||||
Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | Dec. 31, 2012 | Aug. 31, 2012 | Aug. 14, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | Dec. 31, 2012 | Jun. 30, 2010 | |
Senior Subordinated Notes [Member] | Senior Subordinated Notes [Member] | Senior Subordinated Notes [Member] | Senior Subordinated Notes [Member] | Senior Subordinated Notes [Member] | Senior Subordinated Notes [Member] | Senior Subordinated Notes [Member] | Secured Convertible Notes Due June 2015 [Member] | Secured Convertible Notes Due June 2015 [Member] | Secured Convertible Notes Due June 2015 [Member] | Secured Convertible Notes Due June 2015 [Member] | Secured Convertible Notes Due June 2015 [Member] | Secured Convertible Notes Due June 2015 [Member] | |
4.25% Convertible Senior Subordinated Notes due August 15, 2019 [Member] | 4.25% Convertible Senior Subordinated Notes due August 15, 2019 [Member] | 4.25% Convertible Senior Subordinated Notes due August 15, 2019 [Member] | 4.25% Convertible Senior Subordinated Notes due August 15, 2019 [Member] | 4.25% Convertible Senior Subordinated Notes due August 15, 2019 [Member] | 4.25% Convertible Senior Subordinated Notes due August 15, 2019 [Member] | 4.25% Convertible Senior Subordinated Notes due August 15, 2019 [Member] | Deerfield Financing [Member] | Deerfield Financing [Member] | Deerfield Financing [Member] | Deerfield Financing [Member] | Deerfield Financing [Member] | Deerfield Financing [Member] | |
Debt Instrument [Line Items] | |||||||||||||
Debt, interest rate | 4.25% | ||||||||||||
Debt, principal amount | $287,500,000 | $287,500,000 | $287,500,000 | $124,000,000 | |||||||||
Interest Expense, Debt | 7,200,000 | 3,400,000 | 21,200,000 | 3,400,000 | 4,100,000 | 4,100,000 | 11,900,000 | 11,700,000 | |||||
Interest Expense, Coupon Interest | 3,100,000 | 1,500,000 | 9,200,000 | 1,500,000 | |||||||||
Amortization of Financing Costs and Discounts | 4,100,000 | 1,900,000 | 12,000,000 | 1,900,000 | 2,600,000 | 2,500,000 | 7,400,000 | 7,200,000 | |||||
Balance of unamortized closing fees and expenses | 4,100,000 | 4,100,000 | 4,700,000 | 1,600,000 | 1,600,000 | 2,300,000 | |||||||
Convertible Debt | $161,279,000 | $161,279,000 | $149,800,000 | $114,000,000 | $114,000,000 | $124,000,000 |
Debt_Schedule_Of_Debt_Details
Debt (Schedule Of Debt) (Details) (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
In Thousands, unless otherwise specified | ||
Debt Instrument [Line Items] | ||
Total debt | $341,591 | $335,736 |
Less: current portion | -12,127 | -13,170 |
Long-term debt | 329,464 | 322,566 |
Senior Subordinated Notes [Member] | Convertible Senior Subordinated Notes due 2019 [Member] | ||
Debt Instrument [Line Items] | ||
Convertible Debt | 161,279 | 149,800 |
Secured Debt [Member] | Deerfield Notes [Member] | ||
Debt Instrument [Line Items] | ||
Convertible Debt | 97,428 | 100,676 |
Term Loan [Member] | Silicon Valley Bank term loan and Line of Credit [Member] | ||
Debt Instrument [Line Items] | ||
Silicon Valley Bank term loan | 80,000 | 80,000 |
Line of Credit [Member] | Silicon Valley Bank term loan and Line of Credit [Member] | ||
Debt Instrument [Line Items] | ||
Silicon Valley Bank Line of Credit | $2,884 | $5,260 |
Debt_2019_Notes_Details
Debt (2019 Notes) (Details) (Senior Subordinated Notes [Member], 4.25% Convertible Senior Subordinated Notes due August 15, 2019 [Member], USD $) | Sep. 30, 2013 | Dec. 31, 2012 | Aug. 31, 2012 |
Senior Subordinated Notes [Member] | 4.25% Convertible Senior Subordinated Notes due August 15, 2019 [Member] | |||
Debt Instrument [Line Items] | |||
Net carrying amount of the liability component | $161,279,000 | $149,800,000 | |
Unamortized discount of the liability component | 126,221,000 | ||
Face amount | $287,500,000 | $287,500,000 |
Fair_Value_Measurements_Schedu
Fair Value Measurements (Schedule Of Fair Value Of Financial Assets Measured On A Recurring Basis) (Details) (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
In Thousands, unless otherwise specified | ||
Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total fair value of financial assets | $58,102 | $76,050 |
Level 1 [Member] | Money market funds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total fair value of financial assets | 58,102 | 76,050 |
Level 1 [Member] | Commercial paper [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total fair value of financial assets | 0 | 0 |
Level 1 [Member] | Corporate bonds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total fair value of financial assets | 0 | 0 |
Level 1 [Member] | U.S. Treasury and government sponsored enterprises [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total fair value of financial assets | 0 | 0 |
Level 1 [Member] | Municipal bonds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total fair value of financial assets | 0 | 0 |
Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total fair value of financial assets | 402,076 | 552,215 |
Level 2 [Member] | Money market funds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total fair value of financial assets | 0 | 0 |
Level 2 [Member] | Commercial paper [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total fair value of financial assets | 43,592 | 167,231 |
Level 2 [Member] | Corporate bonds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total fair value of financial assets | 266,751 | 221,949 |
Level 2 [Member] | U.S. Treasury and government sponsored enterprises [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total fair value of financial assets | 83,442 | 132,991 |
Level 2 [Member] | Municipal bonds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total fair value of financial assets | 8,291 | 30,044 |
Estimate of Fair Value, Fair Value Disclosure [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total fair value of financial assets | 460,178 | 628,265 |
Estimate of Fair Value, Fair Value Disclosure [Member] | Money market funds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total fair value of financial assets | 58,102 | 76,050 |
Estimate of Fair Value, Fair Value Disclosure [Member] | Commercial paper [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total fair value of financial assets | 43,592 | 167,231 |
Estimate of Fair Value, Fair Value Disclosure [Member] | Corporate bonds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total fair value of financial assets | 266,751 | 221,949 |
Estimate of Fair Value, Fair Value Disclosure [Member] | U.S. Treasury and government sponsored enterprises [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total fair value of financial assets | 83,442 | 132,991 |
Estimate of Fair Value, Fair Value Disclosure [Member] | Municipal bonds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total fair value of financial assets | $8,291 | $30,044 |
Fair_Value_Measurements_Schedu1
Fair Value Measurements (Schedule of Estimated Fair Value of Outstanding Debt) (Details) (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
In Thousands, unless otherwise specified | ||
Carrying Amount [Member] | Senior Subordinated Notes [Member] | 2019 Notes [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Debt Instrument, Fair Value Disclosure | $161,279 | $149,800 |
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] | ||
Debt Instrument, Fair Value Disclosure | 80,000 | 80,000 |
Carrying Amount [Member] | Line of Credit [Member] | Silicon Valley Bank term loan and Line of Credit [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Debt Instrument, Fair Value Disclosure | 2,884 | 5,260 |
Fair Value [Member] | Senior Subordinated Notes [Member] | 2019 Notes [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Debt Instrument, Fair Value Disclosure | 337,928 | 280,111 |
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] | ||
Debt Instrument, Fair Value Disclosure | 79,884 | 79,542 |
Fair Value [Member] | Line of Credit [Member] | Silicon Valley Bank term loan and Line of Credit [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Debt Instrument, Fair Value Disclosure | $2,884 | $5,253 |
StockBased_Compensation_Narrat
Stock-Based Compensation (Narrative) (Details) (USD $) | Sep. 30, 2013 | Dec. 31, 2012 | Sep. 30, 2013 | Sep. 30, 2013 | Sep. 30, 2013 |
In Millions, except Share data, unless otherwise specified | Performance Stock Options [Member] | Stock Options [Member] | Restricted Stock Units (RSUs) [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Options outstanding, in shares | 23,509,515 | 18,448,550 | 3,720,752 | ||
Unrecognized compensation expense | $24.40 | $8 | |||
Unrecognized compensation expense, weighted-average period for recognition (in years) | 2 years 11 months 1 day | 3 years 3 months 29 days |
StockBased_Compensation_Schedu
Stock-Based Compensation (Schedule of Allocated Employee Stock-Based Compensation Expenses) (Details) (USD $) | 3 Months Ended | 9 Months Ended | ||
In Thousands, unless otherwise specified | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Total employee stock-based compensation expense | $2,893 | $1,893 | $8,490 | $6,172 |
Research and development expense [Member] | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Total employee stock-based compensation expense | 1,415 | 970 | 4,326 | 3,202 |
Selling, general and administrative expense [Member] | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Total employee stock-based compensation expense | 1,478 | 923 | 4,115 | 2,970 |
Restructuring Charges [Member] | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Total employee stock-based compensation expense | $0 | $0 | $49 | $0 |
StockBased_Compensation_Schedu1
Stock-Based Compensation (Schedule of Fair Value of Employee Share-Based Payments Awards Estimated Using the Assumptions and Weighted Average Fair Values) (Details) (USD $) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | |
Stock Options [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Weighted average grant date fair value | $2.99 | $3.31 | $2.92 | $3.27 |
Risk-free interest rate | 1.57% | 0.81% | 1.47% | 0.82% |
Dividend yield | 0.00% | 0.00% | 0.00% | 0.00% |
Volatility | 60.00% | 69.00% | 60.00% | 69.00% |
Expected life | 5 years 7 months 6 days | 5 years 7 months 6 days | 5 years 7 months 6 days | 5 years 8 months 12 days |
Employee Stock Purchase Plan [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Weighted average grant date fair value | $1.74 | $1.63 | $1.66 | $2.13 |
Risk-free interest rate | 0.08% | 0.15% | 0.12% | 0.10% |
Dividend yield | 0.00% | 0.00% | 0.00% | 0.00% |
Volatility | 67.00% | 68.00% | 67.00% | 68.00% |
Expected life | 6 months | 6 months | 6 months | 6 months |
StockBased_Compensation_Summar
Stock-Based Compensation (Summary of All Stock Option Activity) (Details) (USD $) | 9 Months Ended |
In Thousands, except Share data, unless otherwise specified | Sep. 30, 2013 |
Shares [Roll Forward] | |
Options outstanding at beginning of period, Shares | 18,448,550 |
Granted, Shares | 5,778,323 |
Exercised, Shares | -4,473 |
Forfeited, Shares | -712,885 |
Options outstanding at end of period, Shares | 23,509,515 |
Exercisable at end of period, Shares | 13,803,103 |
Weighted Average Exercise Price [Roll Forward] | |
Options outstanding at beginning of period, Weighted Average Exercise Price | $6.85 |
Granted, Weighted Average Exercise Price | $5.38 |
Exercised, Weighted Average Exercise Price | $4.42 |
Forfeited, Weighted Average Exercise Price | $6.42 |
Options outstanding at end of period, Weighted Average Exercise Price | $6.50 |
Exercisable at end of period, Weighted Average Exercise Price | $7.23 |
Options outstanding at end of period, Weighted Average Remaining Contractual Term | 4 years 8 months 16 days |
Exercisable at end of period, Weighted Average Remaining Contractual Term | 3 years 6 months 4 days |
Options outstanding at end of period, Aggregate Intrinsic Value, in dollars | $5,709 |
Exercisable at end of period, Aggregate Intrinsic Value, in dollars | $2,376 |
StockBased_Compensation_Summar1
Stock-Based Compensation (Summary of All RSU Activity) (Details) (Restricted Stock Units (RSUs) [Member], USD $) | 9 Months Ended |
In Thousands, except Share data, unless otherwise specified | Sep. 30, 2013 |
Restricted Stock Units (RSUs) [Member] | |
Shares [Roll Forward] | |
RSUs outstanding at beginning of period, Shares | 1,294,621 |
Awarded, Shares | 1,058,668 |
Released, Shares | -230,059 |
Forfeited, Shares | -72,132 |
RSUs outstanding at end of period, Shares | 2,051,098 |
Weighted Average Grant DateFair Value [Roll Forward] | |
RSUs outstanding at beginning of period, Weighted Average Grant Date Fair Value | $6.07 |
Awarded, Weighted Average Grant Date Fair Value | $5.44 |
Released, Weighted Average Grant Date Fair Value | $7.34 |
Forfeited, Weighted Average Grant Date Fair Value | $5.48 |
RSUs outstanding at end of period, Weighted Average Grant Date Fair Value | $5.62 |
RSUs outstanding at end of period, Weighted Average Remaining Contractual Term | 1 year 11 months 23 days |
RSUs outstanding at end of period, Aggregate Intrinsic Value, in dollars | $11,855 |
Income_Taxes_Details
Income Taxes (Details) (USD $) | 12 Months Ended |
In Millions, unless otherwise specified | Dec. 31, 2012 |
Internal Revenue Service (IRS) [Member] | |
Operating Loss Carryforwards [Line Items] | |
Operating Loss Carryforwards | $1,007 |
State and Local Jurisdiction [Member] | |
Operating Loss Carryforwards [Line Items] | |
Operating Loss Carryforwards | 880 |
Effective Income Tax Rate Reconciliation, Tax Credit, Research, Amount | $26 |
Minimum [Member] | Internal Revenue Service (IRS) [Member] | |
Operating Loss Carryforwards [Line Items] | |
Operating Loss Carryforwards, Expiration Date | 31-Dec-18 |
Minimum [Member] | State and Local Jurisdiction [Member] | |
Operating Loss Carryforwards [Line Items] | |
Operating Loss Carryforwards, Expiration Date | 31-Dec-13 |
Maximum [Member] | Internal Revenue Service (IRS) [Member] | |
Operating Loss Carryforwards [Line Items] | |
Operating Loss Carryforwards, Expiration Date | 31-Dec-32 |
Maximum [Member] | State and Local Jurisdiction [Member] | |
Operating Loss Carryforwards [Line Items] | |
Operating Loss Carryforwards, Expiration Date | 31-Dec-32 |
Net_Loss_Per_Share_Details
Net Loss Per Share (Details) (USD $) | 3 Months Ended | 9 Months Ended | ||
In Thousands, except Per Share data, unless otherwise specified | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Net loss, in dollars | ($67,124) | ($32,814) | ($174,014) | ($95,452) |
Shares used in computing basic and diluted net loss per share | 184,149 | 166,354 | 183,957 | 152,316 |
Net loss per share, basic and diluted, in dollars per share | ($0.36) | ($0.20) | ($0.95) | ($0.63) |
Potentially dilutive shares | 81,258 | 71,403 | ||
Convertible debt [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Potentially dilutive shares | 54,123 | 54,123 | ||
Outstanding stock options, unvested RSUs and ESPP contributions [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Potentially dilutive shares | 25,694 | 15,839 | ||
Warrants [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Potentially dilutive shares | 1,441 | 1,441 |
Concentrations_of_Credit_Risk_1
Concentrations of Credit Risk (Details) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | |
Sobi [Member] | Accounts Receivable [Member] | Revenue from Rights Concentration Risk [Member] | ||||
Concentration Risk [Line Items] | ||||
Concentration Risk, Percentage | 14.00% | |||
Bristol-Myers Squibb [Member] | Revenue, Rights Granted [Member] | Revenue from Rights Concentration Risk [Member] | ||||
Concentration Risk [Line Items] | ||||
Concentration Risk, Percentage | 60.00% | 59.00% | ||
Merck [Member] | Revenue, Rights Granted [Member] | Revenue from Rights Concentration Risk [Member] | ||||
Concentration Risk [Line Items] | ||||
Concentration Risk, Percentage | 0.00% | 27.00% | ||
Daiichi Sankyo [Member] | Revenue, Rights Granted [Member] | Revenue from Rights Concentration Risk [Member] | ||||
Concentration Risk [Line Items] | ||||
Concentration Risk, Percentage | 0.00% | 14.00% | ||
Diplomat Specialty Pharmacy [Member] | Accounts Receivable [Member] | Revenue from Rights Concentration Risk [Member] | ||||
Concentration Risk [Line Items] | ||||
Concentration Risk, Percentage | 55.00% | |||
Diplomat Specialty Pharmacy [Member] | Sales Revenue, Goods, Net [Member] | Revenue from Rights Concentration Risk [Member] | ||||
Concentration Risk [Line Items] | ||||
Concentration Risk, Percentage | 36.00% | 0.00% | ||
UNITED STATES | Sales [Member] | Geographic Concentration Risk [Member] | ||||
Concentration Risk [Line Items] | ||||
Concentration Risk, Percentage | 87.00% | 100.00% | 96.00% | 100.00% |