Document And Entity Information
Document And Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Feb. 16, 2017 | Jul. 01, 2016 | |
Document And Entity Information [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 30, 2016 | ||
Document Fiscal Year Focus | 2,016 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | exel | ||
Entity Registrant Name | EXELIXIS, INC. | ||
Entity Central Index Key | 939,767 | ||
Entity Filer Category | Large Accelerated Filer | ||
Current Fiscal Year End Date | --12-30 | ||
Entity Common Stock, Shares Outstanding | 290,866,613 | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Public Float | $ 1,361,396,920 | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Current assets: | ||
Cash and cash equivalents | $ 151,686 | $ 141,634 |
Short-term investments | 268,117 | 25,426 |
Trade and other receivables | 42,246 | 5,183 |
Inventory | 3,338 | 2,616 |
Prepaid expenses and other current assets | 5,416 | 3,806 |
Total current assets | 470,803 | 178,665 |
Long-term investments | 55,601 | 83,600 |
Long-term restricted cash and investments | 4,150 | 2,650 |
Property and equipment, net | 2,071 | 1,434 |
Goodwill | 63,684 | 63,684 |
Other long-term assets | 1,232 | 2,309 |
Total assets | 597,541 | 332,342 |
Current liabilities: | ||
Accounts payable | 6,565 | 6,401 |
Accrued compensation and benefits | 20,334 | 3,629 |
Accrued clinical trial liabilities | 14,131 | 18,071 |
Accrued collaboration liability | 0 | 10,938 |
Current portion of convertible notes | 109,122 | 0 |
Current portion of term loan payable | 80,000 | 0 |
Current portion of deferred revenue | 19,665 | 0 |
Other current liabilities | 20,771 | 13,212 |
Total current liabilities | 270,588 | 52,251 |
Long-term portion of convertible notes | 0 | 337,937 |
Long-term portion of term loan payable | 0 | 80,000 |
Long-term portion of deferred revenue | 237,094 | 0 |
Other long-term liabilities | 541 | 2,960 |
Total liabilities | 508,223 | 473,148 |
Commitments (Note 13) | ||
Stockholders’ equity (deficit): | ||
Preferred stock, $0.001 par value, 10,000,000 shares authorized and no shares issued | 0 | 0 |
Common stock, $0.001 par value; 400,000,000 shares authorized; issued and outstanding: 289,923,798 and 227,960,943 shares at December 31, 2016 and 2015, respectively | 290 | 228 |
Additional paid-in capital | 2,072,591 | 1,772,123 |
Accumulated other comprehensive loss | (416) | (232) |
Accumulated deficit | (1,983,147) | (1,912,925) |
Total stockholders’ equity | 89,318 | (140,806) |
Total liabilities and stockholders’ equity | $ 597,541 | $ 332,342 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2016 | Dec. 31, 2015 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 400,000,000 | 400,000,000 |
Common stock, shares issued | 289,923,798 | 227,960,943 |
Common stock, shares outstanding | 289,923,798 | 227,960,943 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Revenues: | |||
Net product revenues | $ 135,375 | $ 34,158 | $ 25,111 |
Collaboration revenues | 56,079 | 3,014 | 0 |
Total revenues | 191,454 | 37,172 | 25,111 |
Operating expenses: | |||
Cost of goods sold | 6,552 | 3,895 | 2,043 |
Research and development | 95,967 | 96,351 | 189,101 |
Selling, general and administrative | 116,145 | 57,305 | 50,829 |
Restructuring charges | 914 | 1,042 | 7,596 |
Total operating expenses | 219,578 | 158,593 | 249,569 |
Loss from operations | (28,124) | (121,421) | (224,458) |
Other income (expense), net: | |||
Interest income and other, net | 4,863 | 412 | 4,341 |
Interest expense | (33,060) | (40,680) | (41,362) |
Loss on extinguishment of debt | (13,901) | 0 | 0 |
Total other expense, net | (42,098) | (40,268) | (37,021) |
Loss before income taxes | (70,222) | (161,689) | (261,479) |
Income tax provision (benefit) | 0 | 55 | (182) |
Net (loss) income | $ (70,222) | $ (161,744) | $ (261,297) |
Net loss per share, basic and diluted (in dollars per share) | $ (0.28) | $ (0.77) | $ (1.34) |
Shares used in computing basic and diluted net loss per share | 250,531 | 209,227 | 194,299 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | ||
Statement of Comprehensive Income [Abstract] | ||||
Net loss | $ (70,222) | $ (161,744) | $ (261,297) | |
Other comprehensive loss | [1] | (184) | (111) | (267) |
Comprehensive loss | $ (70,406) | $ (161,855) | $ (261,564) | |
[1] | Other comprehensive loss consisted solely of unrealized losses, net on available-for-sale securities arising during the periods presented. There were no reclassification adjustments to net loss resulting from realized gains or losses on the sale of securities and there was no income tax expense related to other comprehensive loss during those years. |
Consolidated Statements of Com6
Consolidated Statements of Comprehensive Loss (Parenthetical) - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Statement of Comprehensive Income [Abstract] | |||
Reclassification adjustments to net loss resulting from realized gains or losses on sale of securities | $ 0 | $ 0 | $ 0 |
Other comprehensive income, tax | $ 0 | $ 0 | $ 0 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity (Deficit) - USD ($) $ in Thousands | Total | Common Stock [Member] | Additional Paid-In Capital [Member] | Accumulated Other Comprehensive (Loss) Income [Member] | Accumulated Deficit [Member] |
Balance at beginning of period at Dec. 31, 2012 | $ 238,127 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (238,192) | ||||
Balance at end of period, shares at Dec. 31, 2013 | 184,533,651 | ||||
Balance at end of period at Dec. 31, 2013 | 14,498 | $ 184 | $ 1,504,052 | $ 146 | $ (1,489,884) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (261,297) | (261,297) | |||
Other comprehensive loss | (267) | (267) | |||
Sale of shares of common stock, net, shares | 10,000,000 | ||||
Sale of shares of common stock, net | 75,643 | $ 10 | 75,633 | ||
Issuance of common stock under stock plans, net, shares | 1,362,118 | ||||
Issuance of common stock under stock plans | 2,093 | $ 2 | 2,091 | ||
Stock-based compensation expense | 10,006 | 10,006 | |||
Balance at end of period, shares at Dec. 31, 2014 | 195,895,769 | ||||
Balance at end of period at Dec. 31, 2014 | (159,324) | $ 196 | 1,591,782 | (121) | (1,751,181) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (161,744) | (161,744) | |||
Other comprehensive loss | (111) | (111) | |||
Sale of shares of common stock, net, shares | 28,750,000 | ||||
Sale of shares of common stock, net | 145,649 | $ 29 | 145,620 | ||
Warrants transferred from other long-term liabilities | 1,470 | 1,470 | |||
Issuance of common stock under stock plans, net, shares | 3,315,174 | ||||
Issuance of common stock under stock plans | 11,277 | $ 3 | 11,274 | ||
Stock-based compensation expense | $ 21,977 | 21,977 | |||
Balance at end of period, shares at Dec. 31, 2015 | 227,960,943 | 227,960,943 | |||
Balance at end of period at Dec. 31, 2015 | $ (140,806) | $ 228 | 1,772,123 | (232) | (1,912,925) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (70,222) | (70,222) | |||
Other comprehensive loss | (184) | (184) | |||
Issuance of common stock in settlement of convertible notes, shares | 54,009,279 | ||||
Issuance of common stock in settlement of convertible notes | 253,080 | $ 54 | 253,026 | ||
Issuance of common stock under stock plans, net, shares | 7,953,576 | ||||
Issuance of common stock under stock plans | 24,538 | $ 8 | 24,530 | ||
Stock-based compensation expense | $ 22,912 | 22,912 | |||
Balance at end of period, shares at Dec. 31, 2016 | 289,923,798 | 289,923,798 | |||
Balance at end of period at Dec. 31, 2016 | $ 89,318 | $ 290 | $ 2,072,591 | $ (416) | $ (1,983,147) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Cash flows from operating activities: | |||
Net loss | $ (70,222) | $ (161,744) | $ (261,297) |
Adjustments to reconcile net loss to net cash provided by (used in) operating activities: | |||
Depreciation and amortization | 1,002 | 1,406 | 2,391 |
Stock-based compensation expense | 22,912 | 21,977 | 10,006 |
Loss on extinguishment of debt | 13,901 | 0 | 0 |
Amortization of debt discounts and debt issuance costs | 8,432 | 17,041 | 22,289 |
Accrual of interest paid in kind | 8,008 | 3,817 | 0 |
Gain on sale of business and other equity investment | (2,494) | (112) | (838) |
Changes in the fair value of warrants | 0 | 548 | (1,840) |
Other | (2,510) | 1,327 | 4,161 |
Changes in assets and liabilities: | |||
Trade and other receivables | (37,002) | (646) | (941) |
Inventory | (722) | (235) | 509 |
Prepaid expenses and other current assets | (1,610) | (325) | 1,526 |
Other long-term assets | 1,077 | 1,340 | (2,149) |
Accounts payable | 164 | (12) | (2,932) |
Accrued compensation and benefits | 16,705 | 279 | (9,447) |
Accrued clinical trial liabilities | (3,940) | (23,474) | 6,587 |
Accrued collaboration liability | (10,938) | 10,206 | 732 |
Deferred revenue | 256,759 | (2,582) | 1,133 |
Other current and long-term liabilities | 6,774 | (10,396) | (5,295) |
Net cash used in operating activities | 206,296 | (141,585) | (235,405) |
Cash flows from investing activities: | |||
Purchases of property and equipment | (1,703) | (447) | (474) |
Proceeds from sale of property and equipment | 97 | 1,346 | 392 |
Proceeds from sale of business and other equity investments | 2,494 | 95 | 838 |
Proceeds from maturities of restricted cash and investments | 7,150 | 19,789 | 20,354 |
Purchase of restricted cash and investments | (8,650) | (5,650) | (8,143) |
Proceeds from sale of investments | 2,266 | 0 | 0 |
Proceeds from maturities of investments | 151,485 | 178,936 | 252,891 |
Purchases of investments | (369,187) | (143,992) | (119,528) |
Net cash (used in) provided by investing activities | (216,048) | 50,077 | 146,330 |
Cash flows from financing activities: | |||
Proceeds from issuance of common stock, net | 0 | 145,649 | 75,643 |
Proceeds from exercise of stock options | 25,327 | 10,911 | 120 |
Proceeds from employee stock purchase plan | 2,187 | 568 | 1,438 |
Principal payments on debt | 0 | (4,381) | (11,709) |
Redemption of convertible notes | (575) | 0 | 0 |
Payments on conversion of convertible notes | (7,135) | 0 | 0 |
Net cash provided by financing activities | 19,804 | 152,747 | 65,492 |
Net increase (decrease) in cash and cash equivalents | 10,052 | 61,239 | (23,583) |
Cash and cash equivalents at beginning of year | 141,634 | 80,395 | 103,978 |
Cash and cash equivalents at end of year | 151,686 | 141,634 | 80,395 |
Supplemental cash flow disclosure: | |||
Cash paid for interest | 21,044 | 19,822 | 19,109 |
Cash paid for taxes | 190 | 192 | 60 |
Non-cash financing activity: | |||
Issuance of common stock in settlement of convertible notes | 286,925 | 0 | 0 |
Issuance of warrants in connection with amendment to convertible notes | $ 0 | $ 0 | $ 2,762 |
Organization and Summary of Sig
Organization and Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2016 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Summary of Significant Accounting Policies | ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Organization Exelixis, Inc. (“Exelixis,” “we,” “our” or “us”) is a biopharmaceutical company committed to the discovery, development and commercialization of new medicines to improve care and outcomes for people with cancer. Since its founding in 1994, three products discovered at Exelixis have progressed through clinical development, received regulatory approval, and entered the commercial marketplace. Two are derived from cabozantinib, an inhibitor of multiple tyrosine kinases including MET, AXL, and VEGF receptors: CABOMETYX™ tablets approved for previously treated advanced kidney cancer and COMETRIQ ® capsules approved for progressive, metastatic medullary thyroid cancer. The third product, Cotellic ® , is a formulation of cobimetinib, a selective inhibitor of MEK, marketed under a collaboration with Genentech (a member of the Roche Group), and is approved as part of a combination regimen to treat advanced melanoma. Basis of Consolidation The consolidated financial statements include the accounts of Exelixis and those of our wholly-owned subsidiaries. These entities’ functional currency is the U.S. dollar. All intercompany balances and transactions have been eliminated. Basis of Presentation We have adopted a 52- or 53-week fiscal year policy that generally ends on the Friday closest to December 31st. Fiscal year 2014, a 53-week year, ended on January 2, 2015; fiscal year 2015, a 52-week year, ended on January 1, 2016; fiscal year 2016, a 52-week year, ended on December 30, 2016; and fiscal year 2017, a 52-week year, will end on December 29, 2017. For convenience, references in this report as of and for the fiscal years ended January 2, 2015, January 1, 2016, and December 30, 2016 are indicated as being as of and for the years ended December 31, 2014, 2015, and 2016, respectively. The quarterly period ended January 2, 2015 is a 14-week fiscal quarter; all other interim periods presented are 13-week fiscal quarters. Use of Estimates The preparation of our consolidated financial statements is in conformity with accounting principles generally accepted in the United States (“U.S.”) which requires management to make judgments, estimates and assumptions that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosures. On an ongoing basis, management evaluates its estimates including, but not limited to, those related to revenue recognition, including deductions from revenues (such as rebates, chargebacks, sales returns and sales allowances), the period of performance, identification of deliverables and evaluation of milestones with respect to our collaborations, the amounts of revenues and expenses under our profit and loss sharing agreement, recoverability of inventory, certain accrued liabilities including the accrued clinical trial liability, the valuation of the debt and equity components of our convertible debt and stock-based compensation. We base our estimates on historical experience and on various other market-specific and other relevant assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results could differ materially from those estimates. Correction of an Immaterial Error During the third quarter of 2016, we identified errors in the Consolidated Balance Sheets and Consolidated Statements of Operations, Comprehensive Loss and Cash Flows for 2015, 2014, 2013, and 2012, and in the unaudited interim Condensed Consolidated Balance Sheets and Condensed Consolidated Statements of Operations, Comprehensive Loss and Cash Flows for all prior interim fiscal periods from September 30, 2012 through June 30, 2016. Specifically, in 2012 we incorrectly calculated 1) the allocation between Additional paid-in capital and Convertible notes of the $287.5 million aggregate principal amount from our 4.25% Convertible Senior Subordinated Notes due 2019 (“2019 Notes”); and 2) the amortization of the debt discount associated with the 2019 Notes during 2012 and all subsequent periods. Having evaluated the materiality of these errors from a quantitative and qualitative perspective, management concluded that although the accumulation of these errors was significant to the three and nine months ended September 30, 2016, the correction of these errors was not material to any individual prior period, and did not have an effect on the trend of financial results, taking into account the requirements of the Securities and Exchange Commission (“SEC”) Staff Accounting Bulletin No. 99, Materiality and Staff Accounting Bulletin No. 108, Considering the Effects of Prior Year Misstatements when Quantifying Misstatements in Current Year Financial Statements . Because management has concluded that these errors are not material, we will correct them prospectively when the consolidated balance sheets, statements of operations, comprehensive loss and cash flows for such periods are included in future filings. Following are the amounts (in thousands, except per share amounts) that should have been reported for the affected line items of the statements of operations, statements of comprehensive loss and statements of cash flows: Year ended December 31, 2015 2014 2013 2012 Statements of Operations: Interest expense, overstated by $7,993, $7,245, $6,568, $2,310 for the years ended December 31, 2015, 2014, 2013 and 2012, respectively $ (40,680 ) $ (41,362 ) $ (38,779 ) $ (24,778 ) Total other expense, net, overstated by $7,993, $7,245, $6,568, $2,310 for the years ended December 31, 2015, 2014, 2013 and 2012, respectively $ (40,268 ) $ (37,021 ) $ (37,556 ) $ (22,792 ) Net loss, overstated by $7,993, $7,245, $6,568, $2,310 for the years ended December 31, 2015, 2014, 2013 and 2012, respectively $ (161,744 ) $ (261,297 ) $ (238,192 ) $ (145,335 ) Net loss per share, basic and diluted, overstated by $0.04, $0.04, $0.04, $0.01 for the years ended December 31, 2015, 2014, 2013 and 2012, respectively $ (0.77 ) $ (1.34 ) $ (1.29 ) $ (0.91 ) Statements of Comprehensive Loss: Comprehensive loss, overstated by $7,993, $7,245, $6,568, $2,310 for the years ended December 31, 2015, 2014, 2013 and 2012, respectively $ (161,855 ) $ (261,564 ) $ (237,954 ) $ (145,289 ) Statements of Cash Flows (1) : Net loss, overstated by $7,993, $7,245, $6,568, $2,310 for the years ended December 31, 2015, 2014, 2013 and 2012, respectively $ (161,744 ) $ (261,297 ) $ (238,192 ) $ (145,335 ) Accretion of debt discount and debt issuance costs, overstated by $7,993, $7,245, $6,568, $2,310 for the years ended December 31, 2015, 2014, 2013 and 2012, respectively $ 17,041 $ 22,289 $ 19,722 $ 12,442 ____________________ (1) The error did not impact our net cash provided by or used in operating activities, financing activities or investing activities for any of the periods presented. Following are the amounts (in thousands) that should have been reported for the affected line items of the balance sheets and statements of stockholders’ (deficit) equity: December 31, 2015 2014 2013 2012 Balance Sheets: Long-term portion of convertible notes, understated by $36,502, $44,494, $51,739, $58,307 as of December 31, 2015, 2014, 2013 and 2012, respectively $ 337,937 $ 223,629 $ 301,550 $ 291,828 Liabilities, understated by $36,502, $44,494, $51,739, $58,307 as of December 31, 2015, 2014, 2013 and 2012, respectively $ 473,148 $ 482,592 $ 483,452 $ 476,015 Additional paid-in capital, overstated by $60,618 as of all dates presented $ 1,772,123 $ 1,591,782 $ 1,504,052 $ 1,489,727 Accumulated deficit, overstated by $24,116, $16,124, $8,879, $2,310 as of December 31, 2015, 2014, 2013 and 2012, respectively $ (1,912,925 ) $ (1,751,181 ) $ (1,489,884 ) $ (1,251,692 ) Stockholders’ equity (deficit), misstated by $36,502, $44,494, $51,739, $58,307 as of December 31, 2015, 2014, 2013 and 2012, respectively $ (140,806 ) $ (159,324 ) $ 14,498 $ 238,127 Statements of Stockholders’ Equity (Deficit): Net loss, overstated by $7,993, $7,245, $6,568, $2,310 for the years ended December 31, 2015, 2014, 2013 and 2012, respectively $ (161,744 ) $ (261,297 ) $ (238,192 ) $ (145,335 ) Additional paid-in capital, overstated by $60,618 as of all dates presented $ 1,772,123 $ 1,591,782 $ 1,504,052 $ 1,489,727 Accumulated deficit, overstated by $24,116, $16,124, $8,879, $2,310 as of December 31, 2015, 2014, 2013 and 2012, respectively $ (1,912,925 ) $ (1,751,181 ) $ (1,489,884 ) $ (1,251,692 ) Stockholders’ equity (deficit), misstated by $36,502, $44,494, $51,739, $58,307 as of December 31, 2015, 2014, 2013 and 2012, respectively $ (140,806 ) $ (159,324 ) $ 14,498 $ 238,127 These errors did not affect any other caption or total in our annual consolidated financial statements. Reclassifications Certain prior period amounts in the Consolidated Financial Statements have been reclassified to conform to current period presentation. We reclassified $3.2 million and $1.4 million of Current portion of restructuring and Long-term portion of restructuring as of December 31, 2015 to Other current liabilities and Other long-term liabilities, respectively, in the accompanying Consolidated Balance Sheets. We have also reclassified balances between line items within the Changes in assets and liabilities in the accompanying Statements of Cash Flows for the years ended December 31, 2015 and 2014 to conform the presentation of those line items to the corresponding presentation of assets and liabilities in our accompanying Balance Sheets. Segment Information We operate as a single reportable segment. Cash and Investments We consider all highly liquid investments purchased with an original maturity of three months or less to be cash equivalents. Cash equivalents include investments in high-grade, short-term money market funds, commercial paper and municipal securities, which are subject to minimal credit and market risk. We have designated all investments as available-for-sale and therefore, such investments are reported at fair value, with unrealized gains and losses recorded in accumulated other comprehensive loss. For securities sold prior to maturity, the cost of securities sold is based on the specific identification method. Realized gains and losses on the sale of investments are recorded in interest and other income, net. We classify those investments we do not require for use in current operations that mature in more than 12 months as Long-term investments on our Consolidated Balance Sheets. Additionally, those investments that collateralize loan balances with terms that extend 12 months or longer were classified as long-term investments even if the investment’s remaining term to maturity was one year or less; they are not restricted to withdrawal. All of our investments are subject to a quarterly impairment review. We recognize an impairment charge when a decline in the fair value of an investment below its cost basis is judged to be other-than-temporary. Factors considered in determining whether a loss is temporary include the length of time and extent to which the investments fair value has been less than their cost basis, the financial condition and near-term prospects of the issuer, extent of the loss related to credit of the issuer, the expected cash flows from the security, our intent to sell the security and whether or not we will be required to sell the security before we are able to recovery our carrying value. During the years ended December 31, 2016 , 2015 and 2014 , we did no t record any other-than-temporary impairment charges on our available-for-sale securities. Fair Value Measurements Fair value 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). We disclose the fair value of financial instruments for assets and liabilities for which the value is practicable to estimate. For those financial instruments measured and recorded at fair value on a recurring basis, we also provide fair value hierarchy information in these Notes to Consolidated Financial Statements. The fair value hierarchy has the following three levels: Level 1 – quoted prices (unadjusted) in active markets for identical assets and liabilities that the reporting entity can access at the measurement date. Level 2 – observable inputs, other than quoted prices in active markets for identical assets and liabilities that are observable either directly or indirectly. 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. During the years ended December 31, 2016 , 2015 and 2014 , there were no such reclassifications. Inventory We value inventory 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 subject to expiry in excess of expected requirements, or that has a cost basis in excess of its expected net realizable value. The related costs are recognized as cost of goods sold in the Consolidated Statements of Operations. On a quarterly basis, we analyze our estimated production levels for the following twelve month period, which is our normal operating cycle and reclassify inventory we do not expect to use within the next twelve months into Other long-term assets in the Consolidated Balance Sheets. 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 are expensed as research and development costs. When regulatory approval is obtained, we begin capitalization of inventory related costs. Property and Equipment Property and equipment are recorded at cost and depreciated using the straight-line method over the following estimated useful lives: Equipment and furniture 5 years Computer equipment and software 3 years Leasehold improvements Shorter of lease life or 7 years Capitalized software includes certain internal use computer software costs. Repairs and maintenance costs are charged to expense as incurred. 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. Goodwill is not subject to amortization. We assess the recoverability of our goodwill annually, or more frequently whenever events or changes in circumstances indicate that the carrying amount of a reporting unit may exceed its fair value. The assessment of recoverability may first consider qualitative factors to determine whether the existence of events or circumstances leads to a determination that it is more likely than not that the fair value of a reporting unit is less than its carrying amount. A quantitative assessment is performed if the qualitative assessment results in a more-likely-than-not determination or if a qualitative assessment is not performed. The quantitative assessment considers whether the carrying amount of a reporting unit exceeds its fair value, in which case an impairment charge is recorded to the extent the carrying amount of the reporting unit’s goodwill exceeds its implied fair value. We continue to operate in one segment, which is also considered to be our sole reporting unit and therefore, goodwill was tested for impairment at the enterprise level as of December 31, 2016 and 2015 . We did no t recognize any impairment charges in any of the periods presented. Long-Lived Assets Long-lived assets include property and equipment. The carrying value of our long-lived assets is reviewed for impairment whenever events or changes in circumstances indicate that the asset may not be recoverable. An impairment loss would be recognized when estimated future cash flows expected to result from the use of the asset and its eventual disposition is less than its carrying amount. Revenue Recognition We recognize revenue from product sales and from license fees, milestones and royalties earned on research and collaboration arrangements. 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 to specialty pharmacies and distributors in the U.S., this generally occurs upon delivery of the product. For product sales to our former distribution partner, Swedish Orphan Biovitrum (“Sobi”), this generally occurred when Sobi accepted the product. In the U.S., we sell our products, CABOMETYX and COMETRIQ, to specialty pharmacies and distributors that benefit from customer incentives and have a right of return under certain circumstances. Prior to 2015, COMETRIQ had limited sales history and we could not reliably estimate expected future returns, discounts and rebates of the product at the time the product was sold to a single specialty pharmacy, therefore we recognized revenue when the specialty pharmacy provided the product to a patient based on the fulfillment of a prescription. This is frequently referred to as the “sell-through” revenue recognition model. In January 2015, we established that we had sufficient historical experience and data to reasonably estimate expected future returns of COMETRIQ and the discounts and rebates due to payers at the time of shipment to the specialty pharmacy. Accordingly, beginning in January 2015 we began to recognize revenue upon delivery to the specialty pharmacy. This approach is frequently referred to as the “sell-in” revenue recognition model. In connection with the change in the timing of recognition of COMETRIQ sales in the U.S., we recorded a one-time adjustment to recognize revenue that had previously been deferred under the “sell-through” revenue recognition model, resulting in the additional recognition of gross product revenues of $2.6 million for the year ended December 31, 2015; there were no such additional amounts recorded during 2016 or 2014. In determining discounts and allowances for the initial launch and sale of CABOMETYX, in addition to using payer data received from the specialty pharmacies and distributors that sell CABOMETYX and historical data for COMETRIQ, we also utilized claims data from third party sources for competitor products for the treatment of advanced renal cell carcinoma (“RCC”). Based in part on the availability of this third party data, we made the determination that we had sufficient experience and data to reasonably estimate expected future returns and the discounts and allowances due to payers at the time of shipment to the specialty pharmacy or distributor, and therefore record revenue for the product using the “sell-in” revenue recognition model. Net product revenues during the year ended December 31, 2016 were impacted by the build of channel inventory related to the initial launch period for CABOMETYX. We also utilized the “sell-in” revenue recognition model for product sales to Sobi for all periods presented. As described further in “Note 2 - Collaboration Agreements”, under the terms of our collaboration and license agreement with Ipsen for the commercialization and further development of cabozantinib, we provided Sobi with a notice of termination of our commercialization agreement for COMETRIQ which became effective November 1, 2016. Product Sales Discounts and Allowances We calculate gross product revenues based on the price that we charge to the specialty pharmacies and distributors in the U.S. We estimate our domestic net product revenues by deducting from our gross product revenues (a) trade allowances, such as discounts for prompt payment, (b) estimated government rebates and chargebacks, (c) certain other fees paid to specialty pharmacies and distributors and (d) returns. Discounts and allowances for foreign sales for the years ended December 31, 2015 and 2014 included portions of a one-time $2.4 million project management fee payable to our European distribution partner upon its achievement of a cumulative revenue goal. During 2014, we determined that the achievement of the revenue goal was probable and therefore we recorded $2.3 million of the $2.4 million project management fee, of which $0.7 million would have been recorded in 2013 had the cumulative revenue goal been determined to be probable in that period. During 2015 we recorded an additional $0.1 million of the project management fee. 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. Customer Credits: The specialty pharmacies and distributors in the U.S. receive a discount of 2% for prompt payment. We expect the specialty pharmacies and distributors 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 third party market research data and customer and payer data received from the specialty pharmacies and distributors and historical utilization rates. Rebates are generally invoiced by the payer 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 our customers, 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 or distributor. Contracted customers, which currently consist primarily of Public Health Service institutions, non-profit clinics, Federal government entities purchasing via the Federal Supply Schedule and Group Purchasing Organizations, generally purchase the product at a discounted price. The specialty pharmacy or distributor, 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 an estimate of sales to contracted customers. Medicare Part D Coverage Gap: In the U.S., 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 payer data received from specialty pharmacies and distributors. 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 quarters’ 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 the specialty pharmacies and distributors. Collaboration Revenues We enter into collaboration agreements under which we may obtain upfront license fees, milestone, royalty and/or product supply payments. These arrangements have multiple elements and our deliverables may include intellectual property rights, distribution rights, delivery of manufactured product, commercial and development activities and participation on joint steering, commercial and development committees. In order to account for these arrangements, we identify the deliverables and evaluate whether the delivered elements have value to our collaboration partner on a stand-alone basis and represent separate units of accounting. Analyzing the arrangement to identify deliverables requires the use of judgment, and each deliverable may be an obligation to deliver future goods or services, a right or license to use an asset, or another performance obligation. If we determine that multiple deliverables exist, the consideration is allocated to one or more units of accounting based upon the best estimate of the selling price of each deliverable. The selling price used for each deliverable will be based on vendor-specific objective evidence, if available, third-party evidence if vendor-specific objective evidence is not available, or estimated selling price if neither vendor-specific or third-party evidence is available. A delivered item or items that do not qualify as a separate unit of accounting within the arrangement shall be combined with the other applicable undelivered items within the arrangement. The allocation of arrangement consideration and the recognition of revenue then shall be determined for those combined deliverables as a single unit of accounting. For a combined unit of accounting, non-refundable upfront fees are recognized in a manner consistent with the final deliverable, which has generally been ratably over the period of our continued involvement. Amounts received in advance of performance are recorded as deferred revenue. Upfront fees are classified as Collaboration revenues in our Consolidated Statements of Operations. Royalty revenues, and U.S. profits and losses under the collaboration agreement with Genentech, are based on amounts reported to us by our collaboration partners and are recorded when such information becomes available to us; for Ipsen, this occurs in the current quarter, and for Genentech, this occurs in the following quarter. We base our estimates on the best information available at the time provided to us by our collaboration partners. However, additional information may subsequently become available to us, which may allow us to make a more accurate estimate in future periods. In this event, we are required to record adjustments to collaboration revenue in future periods when the actual level of activity becomes more certain. Such increases or decreases in revenue are generally considered to be changes in estimates and will be reflected in collaboration revenues in the period they become known. We consider sales-based contingent payments to be royalty revenue which is generally recognized at the date the contingency is achieved. Royalty revenue is included in Collaboration revenues in our Consolidated Statements of Operations. For product supplied to Ipsen, which began during the year ended December 31, 2016, we record revenue at the time the product is delivered. Once title has transferred to Ipsen, the product is generally no longer subject to return. See “Note 2. Collaboration Agreements - Ipsen Collaboration” for a description of our product supply agreement with Ipsen. For certain milestone payments under collaboration agreements, we have made a policy election to recognize revenue using the milestone method. Under the milestone method a payment that is contingent upon the achievement of a substantive milestone is recognized in its entirety in the period in which the milestone is achieved. A milestone is an event: (i) that can be achieved based in whole or in part on either our performance or on the occurrence of a specific outcome resulting from our performance, (ii) for which there is substantive uncertainty at the date the arrangement is entered into that the event will be achieved and (iii) that would result in additional payments being due to us. The determination that a milestone is substantive requires estimation and judgment and is made at the inception of the arrangement. Milestones are considered substantive when the consideration earned from the achievement of the milestone is: (i) commensurate with either our performance to achieve the milestone or the enhancement of value of the item delivered as a result of a specific outcome resulting from our performance to achieve the milestone, (ii) relates solely to past performance and (iii) reasonable relative to all deliverables and payment terms in the arrangement. In making the determination as to whether a milestone is substantive or not, we consider all facts and circumstances relevant to the arrangement, including factors such as the scientific, regulatory, commercial and other risks that must be overcome to achieve the respective milestone, the level of effort and investment required to achieve the respective milestone and whether any portion of the milestone consideration is related to future performance or deliverables. Non-substantive milestone payments are recognized as revenues over the estimated period of our continued involvement. We may also receive milestone payments after the end of our continued involvement. In such circumstances, we would recognize 100% of the milestone revenues when the contingency is achieved. Milestones payments, when recognized as revenue, are classified as Collaboration revenues in our Consolidated Statements of Operations. Under the terms of our collaboration agreement with Genentech for cobimetinib, we are also entitled to a share of U.S. profits and losses received in connection with commercialization of cobimetinib. We are entitled to low double-digit royalties on ex-U.S. net sales. See “Note 2. Collaboration Agreements” for additional information about our collaboration agreement with Genentech. We have determined that we are an agent under the agreement and therefore revenues are recorded net of costs incurred. We record U.S. profits and losses under the collaboration agreement in the period earned based on our estimate of those amounts. As of December 31, 2016, we have not recognized a profit for any year to date period from the commercialization of cobimetinib in the U.S. Until we have recognized a profit under the agreement, losses are recognized as Selling, general and administrative expenses in our Consolidated Statements of Operations. In connection with our agreement to co-promote with Genentech, we are responsible for providing up to 25% of the sales force necessary to assist with the promotion of cobimetinib. Genentech reimburses us for these costs which we include as a reduction of our Selling, general and administrative costs when the obligations are incurred or we become entitled to the cost recovery. Patient Assistance Programs We provide CABOMETYX and COMETRIQ at no cost to eligible patients who have no insurance and meet certain financial and clinical criteria through our patient assistance programs. We record the cost of the product as a selling, general and administrative expense at the time the product is shipped to the specialty pharmacy for patient assistance use. Cost of Goods Sold Cost of goods sold is related to our product revenues and consists primarily of a 3% royalty on net sales of any product incorporating cabozantinib payable to GlaxoSmithKline, indirect labor costs, the cost of manufacturing, write-downs related to expiring and excess inventory, and other third party logistics costs of our product. A portion of the manufacturin |
Collaboration Agreements
Collaboration Agreements | 12 Months Ended |
Dec. 31, 2016 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Collaboration Agreements | COLLABORATION AGREEMENTS Ipsen Collaboration In February 2016, we entered into a collaboration and license agreement with Ipsen for the commercialization and further development of cabozantinib. Pursuant to the terms of the collaboration agreement, Ipsen received exclusive commercialization rights for current and potential future cabozantinib indications outside of the U.S., Canada and Japan. The collaboration agreement was subsequently amended in December 2016 to include commercialization rights in Canada (the “Amendment”). We have also agreed to collaborate with Ipsen on the development of cabozantinib for current and potential future indications. In consideration for the exclusive license and other rights contained in the collaboration and license agreement, Ipsen paid us an upfront nonrefundable payment of $200.0 million in March 2016. Additionally, as a result of the Amendment, we received a $10.0 million upfront nonrefundable payment from Ipsen in December 2016. As a result of the approval of cabozantinib in second-line RCC by the European Commission in September 2016, we received a $60.0 million milestone in November 2016. We are also eligible to receive additional development and regulatory milestones, totaling up to $254.0 million , including, milestone payments of $10.0 million and $40.0 million upon the filing and the approval of cabozantinib in second-line hepatocellular carcinoma (“HCC”) with the European Medicines Agency (“EMA”), and additional milestones for other future indications and/or jurisdictions. In the fourth quarter of 2016 we achieved two $10.0 million milestones for the first commercial sales of CABOMETYX in Germany and the United Kingdom. The collaboration agreement also provides that we will be eligible to receive contingent payments of up to $544.7 million associated with the achievement of specified levels of Ipsen sales to end users. We will also receive royalties on net sales of cabozantinib outside of the U.S. and Japan. We will receive a 2% royalty on the initial $50.0 million of net sales, and a 12% royalty on the next $100.0 million of net sales. After the initial $150.0 million of sales, we will receive a tiered royalty of 22% to 26% on annual net sales; these tiers will reset each calendar year. We are primarily responsible for funding cabozantinib related development costs for existing trials; global development costs for potential future trials will be shared between the parties, with Ipsen to reimburse us for 35% of such costs. Pursuant to the terms of the collaboration agreement, we will remain responsible for the manufacture and supply of cabozantinib for all development and commercialization activities under the collaboration agreement. As part of the collaboration agreement, we entered into a supply agreement which provides that through the end of the second quarter of 2018, we will supply finished, labeled product to Ipsen for distribution in the territories outside of the U.S. and Japan at our cost, as defined in the agreement, which excludes, among other items, the 3% royalty we are required to pay GlaxoSmithKline on Ipsen’s Net Sales of any product incorporating cabozantinib. From the end of the second quarter of 2018 forward, we will continue to manufacture cabozantinib tablets and capsules while Ipsen will be responsible for packaging and labeling the products in territories where they have been approved outside of the U.S. and Japan, as applicable. The collaboration agreement contains multiple elements, and the deliverables under the collaboration agreement consist of intellectual property licenses, delivery of products and/or materials containing cabozantinib to Ipsen for all development and commercial activities, research and development services, and participation on the joint steering and development committees (as defined in the collaboration agreement). These deliverables are non-contingent in nature. We determined that these deliverables do not have stand-alone value, because each one of them has value only if we meet our obligation to provide Ipsen with cabozantinib, which is deemed to be the predominant deliverable under the collaboration agreement. We also determined that the level of effort required of us to meet our obligations under the collaboration agreement is not expected to vary significantly over the life of the collaboration agreement. Accordingly, we combined these deliverables into a single unit of accounting and allocated the entire arrangement consideration to that combined unit of accounting. As a result, the upfront payment of $200.0 million , received in the first quarter of 2016 and the $10.0 million upfront payment received in December 2016 in consideration for the development and commercialization rights in Canada are being recognized ratably over the remaining term of the collaboration agreement. The collaboration agreement continues through early 2030, which is the current estimated patent expiration of cabozantinib in the European Union. At the time we entered into the agreement, we also determined that the $60.0 million milestone we achieved upon the approval of cabozantinib by the EC in second-line RCC was not substantive due to the relatively low degree of uncertainty and relatively low amount of effort required on our part to achieve the milestone as of the date of the collaboration agreement; the $60.0 million was deferred as of the date of the EMA’s approval of cabozantinib in second-line RCC in September 2016 and is being recognized ratably over the remaining term of the collaboration agreement. The two $10.0 million milestones for the first commercial sales of CABOMETYX in Germany and the United Kingdom were determined to be substantive at the time we entered into the collaboration agreement and were recognized as collaboration revenues in the fourth quarter of 2016. We determined that the remaining development and regulatory milestones are substantive and will be recognized as revenue in the periods in which they are achieved. We consider the contingent payments due to us upon the achievement of specified sales volumes to be similar to royalty payments. Subsequent to February 29, 2016, we transferred the intellectual property rights to Ipsen, and participated in regulatory filing activities and planning for the production, delivery and distribution of manufactured product. As a result of these activities, we began to recognize of the upfront payment under the collaboration agreement at that time. During the year ended December 31, 2016 , collaboration revenues under the collaboration agreement were as follows (in thousands): Year Ended December 31, 2016 Milestones achieved $ 20,000 Amortization of upfront payments and deferred milestone 13,284 Royalty revenue 175 Product supply agreement revenue 1,612 Cost of supplied product (1,555 ) Royalty payable to GlaxoSmithKline on net sales by Ipsen (264 ) Collaboration revenues under the collaboration agreement $ 33,252 As of December 31, 2016 , short-term and long-term deferred revenue relating to the collaboration agreement was $19.6 million and $237.1 million , respectively. In connection with the establishment of the collaboration agreement, we provided Sobi with a notice of termination of our distribution and commercialization agreement for COMETRIQ. Effective November 1, 2016, Ipsen became responsible for the distribution and commercialization of COMETRIQ for the approved medullary thyroid carcinoma indication in territories previously supported by Sobi. Pursuant to our commercialization agreement with Sobi, we were required to pay a $2.9 million termination fee during the year ended December 31, 2016 , which was included in Selling, general and administrative expenses in the accompanying Consolidated Statements of Operations. Additionally, we were also required to issue a $0.4 million credit for unsold product to Sobi during the year ended December 31, 2016 , which is included as a reduction of Net product revenues in the accompanying Consolidated Statements of Operations. Genentech Collaboration In December 2006, we out-licensed the development and commercialization of cobimetinib to Genentech pursuant to a worldwide collaboration agreement. The FDA approved cobimetinib in the U.S. under the brand name Cotellic on November 10, 2015. It is indicated in combination with Zelboraf as a treatment for patients with BRAF V600E or V600K mutation-positive advanced melanoma. Cotellic in combination with Zelboraf has also been approved in Switzerland, the European Union, Canada, Australia and Brazil for use in the same indication. Under the terms of the agreement, we were responsible for developing cobimetinib through the determination of the maximum-tolerated dose in a phase 1 clinical trial, and Genentech had the option to co-develop cobimetinib, which Genentech could exercise after receipt of certain phase 1 data from us. In March 2008, Genentech exercised its option to co-develop cobimetinib. In March 2009, we granted to Genentech an exclusive worldwide revenue-bearing license to cobimetinib, at which point Genentech became responsible for completing the phase 1 clinical trial and subsequent clinical development. Under the terms of our collaboration agreement with Genentech for cobimetinib, we are entitled to a share of U.S. profits and losses received in connection with commercialization of cobimetinib. The profit and loss share has multiple tiers: we are entitled to 50% of profits and losses from the first $200.0 million of U.S. actual sales, decreasing to 30% of profits and losses from U.S. actual sales in excess of $400.0 million . In addition, we are entitled to low double-digit royalties on ex-U.S. net sales. In November 2013, we exercised an option under the collaboration agreement to co-promote in the U.S. Following the approval of Cotellic in the U.S. in November 2015, we began fielding 25% of the sales force promoting Cotellic in combination with Zelboraf as a treatment for patients with BRAF V600E or V600K mutation-positive advanced melanoma. On June 3, 2016, following a 30 day dispute resolution period, we filed a demand for arbitration asserting claims against Genentech related to its clinical development, pricing and commercialization of Cotellic, and cost and revenue allocations in connection with Cotellic’s commercialization in the United States. Soon thereafter, Genentech asserted a counterclaim for breach of contract seeking monetary damages and interest related to the cost allocations under the collaboration agreement. On December 29, 2016, Genentech withdrew its counterclaim against us in the ongoing JAMS arbitration concerning alleged breaches of the parties’ collaboration agreement. When notifying the arbitral panel and us of this unilateral action, Genentech further stated that it changed, both retroactively and prospectively, the manner in which it allocates promotional expenses of the Cotellic plus Zelboraf combination therapy. As a result of Genentech’s decision to change its cost allocation approach, we are relieved of our obligation to pay $18.7 million of disputed costs that had been accrued by us as of September 30, 2016. We have invoiced Genentech for certain expenses, with interest, that we had previously paid. Accordingly, during the year ended December 31, 2016, we offset Selling, general and administrative expenses with a $13.3 million recovery for disputed losses that had been recognized prior to 2016. During the year ended December 31, 2016, we also recognized a loss under the collaboration agreement of $4.5 million for 2016 activities under the collaboration agreement as computed under Genentech’s revised cost allocation approach. Taken together, we have recorded a net cost recovery of $8.8 million during the year ended December 31, 2016 under the collaboration agreement. During the years ended December 31, 2016 , 2015 and 2014, collaboration revenues and (loss) net cost recovery under the collaboration agreement were as follows (in thousands): Year Ended December 31, 2016 2015 2014 Collaboration revenues: Royalty revenues on ex-U.S. sales of COTELLIC $ 2,827 $ 14 $ — (Loss) net cost recovery under the collaboration agreement included in Selling, general and administrative expenses $ 8,771 $ (16,600 ) $ (2,916 ) The (loss) net cost recovery under the collaboration agreement includes personnel and other costs we have incurred to co-promote Cotellic plus Zelboraf in the U.S. As of December 31, 2015, a portion of the liability for those costs, identified as Accrued collaboration liability on the accompanying Consolidated Balance Sheets, included commercialization expenses that Genentech had allocated to the collaboration but remained under discussion between us and Genentech. Other Collaborations We have established collaborations with other leading pharmaceutical and biotechnology companies, including Daiichi Sankyo Company Limited (“Daiichi Sankyo”), Merck (known as MSD outside of the U.S. and Canada), Bristol-Myers Squibb Company (“BMS”), Sanofi and GlaxoSmithKline, for various compounds and programs in our portfolio. Pursuant to these collaborations, we have fully out-licensed compounds or programs to a partner for further development and commercialization. Under each of our collaborations, we are entitled to receive milestones and royalties. With respect to our partnered compounds, other than cabozantinib and cobimetinib, we are eligible to receive potential contingent payments totaling approximately $2.2 billion in the aggregate on a non-risk adjusted basis, of which 9% are related to clinical development milestones, 42% are related to regulatory milestones and 49% are related to commercial milestones, all to be achieved by the various licensees, which may not be paid, if at all, until certain conditions are met. Daiichi Sankyo In March 2006, we entered into a collaboration agreement with Daiichi Sankyo for the discovery, development and commercialization of novel therapies targeted against the mineralocorticoid receptor (“MR”), a nuclear hormone receptor implicated in a variety of cardiovascular and metabolic diseases. Under the terms of the agreement, we granted to Daiichi Sankyo an exclusive, worldwide license to certain intellectual property primarily relating to compounds that modulate MR, including CS-3150/esaxerenone (a specific rotational isomer of XL550). Daiichi Sankyo is responsible for all further preclinical and clinical development, regulatory, manufacturing and commercialization activities for the compounds and we do not have rights to reacquire such compounds, except as described below. We are eligible to receive additional development, regulatory and commercialization milestone payments of up to $130.0 million . In addition, we are also entitled to receive royalties on any sales of certain products commercialized under the collaboration. Daiichi Sankyo may terminate the agreement upon ninety days’ written notice in which case Daiichi Sankyo’s payment obligations would cease, its license relating to compounds that modulate MR would terminate and revert to us and we would receive, subject to certain terms and conditions, licenses from Daiichi Sankyo to research, develop and commercialize compounds that were discovered under the collaboration. We recognized contract revenues of $15.0 million from milestone payments during the year ended December 31, 2016 under our collaboration agreement with Daiichi Sankyo. We did no t recognize any such revenue during the years ended December 31, 2015 and 2014. Merck In December 2011, we entered into an agreement with Merck pursuant to which we granted Merck an exclusive worldwide license to our PI3K-delta (“PI3K-d”) program, including XL499 and other related compounds. Pursuant to the terms of the agreement, Merck has sole responsibility to research, develop, and commercialize compounds from our PI3K-d program. The agreement became effective in December 2011. We will be eligible to receive payments associated with the successful achievement of potential development and regulatory milestones for multiple indications of up to $231.0 million . We will also be eligible to receive payments for combined sales performance milestones of up to $375.0 million and royalties on net-sales of products emerging from the agreement. Contingent payments associated with milestones achieved by Merck and royalties are payable on compounds emerging from our PI3K-d program or from certain compounds that arise from Merck’s internal discovery efforts targeting PI3K-d during a certain period. We recognized contract revenues of $5.0 million and $3.0 million from milestone payments during the years ended December 31, 2016 and 2015, respectively, under our collaboration agreement with Merck. We did no t recognize any such revenue during the year ended December 31, 2014. Bristol-Myers Squibb ROR Collaboration Agreement In October 2010, we entered into a worldwide collaboration with BMS pursuant to which each party granted to the other certain intellectual property licenses to enable the parties to discover, optimize and characterize ROR antagonists that may subsequently be developed and commercialized by BMS. Since the collaborative research period ended in July 2013, BMS has and will continue to have sole responsibility for any further research, development, manufacture and commercialization of products developed under the collaboration and will bear all costs and expenses associated with those activities. For each product developed by BMS under the collaboration, we will be eligible to receive payments upon the achievement by BMS of development and regulatory milestones of up to $252.5 million in the aggregate and commercialization milestones of up to $150.0 million in the aggregate, as well as royalties on commercial sales of any such products. We did no t any recognize any revenue under our ROR collaboration agreement with BMS during the three years ended December 31, 2016. LXR Collaboration Agreement In December 2005, we entered into a collaboration agreement with BMS for the discovery, development and commercialization of novel therapies targeted against LXR, a nuclear hormone receptor implicated in a variety of cardiovascular and metabolic disorders. This agreement became effective in January 2006, at which time we granted BMS an exclusive worldwide license with respect to certain intellectual property primarily relating to compounds that modulate LXR. The research term expired in January 2010 and we transferred the technology to BMS in 2011 to enable it to continue the LXR program. We have been advised that BMS is continuing additional preclinical research on the program. Under the collaboration agreement, BMS is required to pay us contingent amounts associated with development and regulatory milestones of up to $53.0 million per product for up to two products from the collaboration. In addition, we are also entitled to receive payments associated with sales milestones of up to $310.0 million and royalties on sales of any products commercialized under the collaboration. We did no t recognize any revenue under our LXR collaboration agreement with BMS during the three years ended December 31, 2016. Sanofi In May 2009, we entered into a global license agreement with Sanofi for SAR245408 (XL147) and SAR245409 (XL765), leading inhibitors of phosphoinositide-3 kinase (“PI3K”), and a broad collaboration for the discovery of inhibitors of PI3K for the treatment of cancer. The license agreement and collaboration agreement became effective on July 7, 2009. We will be eligible to receive contingent payments associated with development, regulatory and commercial milestones under the license agreement of $745.0 million in the aggregate, as well as royalties on sales of any products commercialized under the license. We did no t recognize any revenue under our collaboration agreement with Sanofi during the three years ended December 31, 2016. GlaxoSmithKline In October 2002, we established a collaboration with GlaxoSmithKline to discover and develop novel therapeutics in the areas of vascular biology, inflammatory disease and oncology. Under the terms of the product development and commercialization agreement, GlaxoSmithKline had the right to choose cabozantinib for further development and commercialization, but notified us in October 2008 that it had waived its right to select the compound for such activities. As a result, we retained the rights to develop, commercialize, and license cabozantinib, subject to payment to GlaxoSmithKline of a 3% royalty on net sales of any product incorporating cabozantinib. The product development and commercialization agreement was terminated during 2014, although GlaxoSmithKline will continue to be entitled to a 3% royalty on net sales of any product incorporating cabozantinib, including COMETRIQ and CABOMETYX. In connection with the sales of COMETRIQ and CABOMETYX, during the years ended December 31, 2016, 2015 and 2014 we recorded $4.3 million , $1.0 million and $0.7 million , respectively, in royalties payable to GlaxoSmithKline. Royalty expense is included in Cost of goods sold for sales by us and as a reduction of Collaboration revenue for sales by Ipsen in the accompanying Consolidated Statements of Operations. |
Restructurings
Restructurings | 12 Months Ended |
Dec. 31, 2016 | |
Restructuring Charges [Abstract] | |
Restructurings | RESTRUCTURINGS Between March 2010 and May 2013, we implemented five restructurings (which we refer to collectively as the “2010 Restructurings”) to manage costs and as a consequence of our decision in 2010 to focus our proprietary resources and development efforts on the development and commercialization of cabozantinib. The aggregate reduction in headcount from the 2010 Restructurings was 429 employees. Charges and credits related to the 2010 Restructurings were recorded in periods other than those in which the 2010 Restructurings were implemented as a result of sublease activities for certain of our buildings in South San Francisco, California, changes in assumptions regarding anticipated sublease activities, the effect of the passage of time on our discounted cash flow computations, previously planned employee terminations, and sales of excess equipment and other assets. In September 2014, as a consequence of the failure of COMET-1, one of our two phase 3 pivotal trials of cabozantinib in metastatic castration-resistant prostate cancer, we initiated a restructuring (which we refer to as the “2014 Restructuring”) to reduce our workforce. The aggregate reduction in headcount from the 2014 Restructuring was 143 employees. The principal objective of the 2014 Restructuring was to enable us to focus our financial resources on the phase 3 pivotal trials of cabozantinib in advanced RCC and advanced HCC. The total outstanding current and long-term restructuring liability is included in Other current liabilities and Other long-term liabilities, respectively, on the accompanying Consolidated Balance Sheets. The changes of these liabilities and the cumulative restructuring charge from inception to date are summarized in the following table (in thousands): 2010 Restructurings 2014 Restructuring Facility Other Employee Severance and Other Benefits Facility Other Total Restructuring liability as of December 31, 2013 $ 13,460 $ 12 $ — $ — $ — $ 13,472 Restructuring charge (recovery) 1,626 (117 ) 5,775 65 247 7,596 Proceeds from sale of assets — 199 — — 100 299 Other cash payments, net (5,644 ) (8 ) (4,507 ) (65 ) (12 ) (10,236 ) Other items 12 (86 ) 22 — (288 ) (340 ) Restructuring liability as of December 31, 2014 9,454 — 1,290 — 47 10,791 Restructuring charge (recovery) 757 — (269 ) 1,582 (1,028 ) 1,042 Proceeds from sale of assets — — — — 1,325 1,325 Other cash payments, net (6,449 ) — (1,021 ) (1,357 ) — (8,827 ) Other items 325 — — 278 (344 ) 259 Restructuring liability as of December 31, 2015 4,087 — — 503 — 4,590 Restructuring charge 902 — — 12 — 914 Other cash payments, net (4,039 ) — — (500 ) (34 ) (4,573 ) Other items 975 — — — 34 1,009 Restructuring liability as of December 31, 2016 $ 1,925 $ — $ — $ 15 $ — $ 1,940 Restructuring charge (recovery) from implementation to date $ 32,517 $ 23,933 (1) $ 5,506 $ 1,659 $ (781 ) (1) $ 62,834 ____________________ (1) Other restructuring charge from implementation to date for the 2010 Restructurings includes $21.7 million in charges related to employee severance and other benefits for periods ended prior to December 31, 2013. The remainder of Other activity for both restructurings relates primarily to the impairment and sale of property and equipment. The restructuring charge for the year ended December 31, 2016 included $0.8 million in charges related to a tenant’s default on an existing sublease which was partially offset by a $0.1 million recovery related to a new sublease executed in July 2016. The restructuring charge for the year ended December 31, 2015 included $1.6 million in additional charges due to the partial termination of one of our building leases and additional facility-related charges related to the decommissioning and exit of certain buildings, which was partially offset by $1.0 million in recoveries recorded in connection with the sale of excess equipment and other assets that had previously been fully depreciated and the reversal of severance charges recorded in 2014 for employees that were recalled in 2015. The restructuring charge for the year ended December 31, 2014 includes $5.8 million of employee severance and other benefits and we recorded charges of $0.3 million for property and equipment write-downs and other charges. The charges for all periods presented include the effect of the passage of time on our discounted cash flow computations (“accretion expense”) for the exit, in prior periods, of certain of our South San Francisco buildings and changes in estimates regarding future subleases. We expect to pay accrued facility charges of $1.9 million , net of cash received from our subtenants, through the end of the lease terms of the buildings, all of which end in May 2017. |
Cash and Investments
Cash and Investments | 12 Months Ended |
Dec. 31, 2016 | |
Investments, Debt and Equity Securities [Abstract] | |
Cash and Investments | CASH AND INVESTMENTS Cash and Investments Available-for-Sale The following tables summarize cash and cash equivalents, investments, and restricted cash and investments by balance sheet line item as of December 31, 2016 and 2015 (in thousands): December 31, 2016 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Cash and cash equivalents $ 151,686 $ — $ — $ 151,686 Short-term investments 268,234 13 (130 ) 268,117 Long-term investments 55,792 1 (192 ) 55,601 Long-term restricted investments 4,150 — — 4,150 Total cash and investments $ 479,862 $ 14 $ (322 ) $ 479,554 December 31, 2015 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Cash and cash equivalents $ 141,634 $ — $ — $ 141,634 Short-term investments 25,484 5 (63 ) 25,426 Long-term investments 83,665 2 (67 ) 83,600 Long-term restricted investments 2,650 — — 2,650 Total cash and investments $ 253,433 $ 7 $ (130 ) $ 253,310 Under our loan and security agreement with Silicon Valley Bank, we are required to maintain compensating balances on deposit in one or more investment accounts with Silicon Valley Bank or one of its affiliates. The total collateral balances were $81.6 million as of both December 31, 2016 and 2015 and are reflected in our Consolidated Balance Sheets in short-term investments as of December 31, 2016 and long-term investments as of December 31, 2015 ; the change in classification from long-term to short-term was the result of a corresponding change in the classification for our term loan payable to Silicon Valley Bank which matures in May 2017. See “Note 7. Debt” for more information regarding the collateral balance requirements under our Silicon Valley Bank loan and security agreement. The following table summarizes our cash equivalents and investments by security type as of December 31, 2016 and 2015 . The amounts presented exclude cash, but include investments classified as cash equivalents (in thousands): December 31, 2016 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Money market funds $ 71,457 $ — $ — $ 71,457 Commercial paper 165,375 — — 165,375 Corporate bonds 152,712 3 (308 ) 152,407 U.S. Treasury and government sponsored enterprises 70,730 11 (14 ) 70,727 Total investments $ 460,274 $ 14 $ (322 ) $ 459,966 December 31, 2015 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Money market funds $ 72,000 $ — $ — $ 72,000 Commercial paper 78,155 — — 78,155 Corporate bonds 72,205 4 (118 ) 72,091 U.S. Treasury and government sponsored enterprises 28,434 1 (12 ) 28,423 Marketable equity securities 16 2 — 18 Total investments $ 250,810 $ 7 $ (130 ) $ 250,687 There were no gains or losses on the sales of investments available-for-sale during the years ended December 31, 2016 , 2015 and 2014 . All of our investments are subject to a quarterly impairment review. During the years ended December 31, 2016 , 2015 and 2014 we did no t record any other-than-temporary impairment charges on our available-for-sale securities. As of December 31, 2016 , there were 86 investments in an unrealized loss position with gross unrealized losses of $322,000 and an aggregate fair value of $172.1 million . The investments in an unrealized loss position comprise corporate bonds with an aggregate fair value of $143.5 million and the remainder comprises primarily securities issued by U.S. Treasury and government sponsored enterprises. 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 December 31, 2016 (in thousands): Mature within One Year After One Year through Two Years Fair Value Money market funds $ 71,457 $ — $ 71,457 Commercial paper 165,375 — 165,375 Corporate bonds 99,455 52,952 152,407 U.S. Treasury and government sponsored enterprises 68,078 2,649 70,727 Total $ 404,365 $ 55,601 $ 459,966 Cash is excluded from the table above. The classification of certain compensating balances and restricted investments are dependent upon the term of the underlying restriction on the asset and not the maturity date of the investment. Therefore, certain long-term investments and long-term restricted cash and investments have contractual maturities within one year. Other Cost Method Equity Investments During the year ended December 31, 2016 we recognized a $2.5 million gain on the sale of our 9% interest in Akarna Therapeutics, Ltd. The gain on the sale is included in Interest income and other, net in our Consolidated Statements of Operations. The gain on sale of other cost method equity investments was either nominal or zero during the years ended December 31, 2015 and 2014. As of December 31, 2016 and 2015, the carrying values of such investments were $0 . |
Inventory
Inventory | 12 Months Ended |
Dec. 31, 2016 | |
Inventory Disclosure [Abstract] | |
Inventory | INVENTORY Inventory consists of the following (in thousands): December 31, 2016 2015 Raw materials $ 863 $ 1,037 Work in process 2,343 2,251 Finished goods 738 583 Total 3,944 3,871 Less: non-current portion included in Other long-term assets (606 ) (1,255 ) Inventory $ 3,338 $ 2,616 We generally relieve inventory on a first-expiry, first-out basis. A portion of the manufacturing costs for inventory were incurred prior to regulatory approval of CABOMETYX and COMETRIQ and, therefore, were expensed as research and development costs when those costs were incurred, rather than capitalized as inventory. Write-downs related to expiring and excess inventory are charged to cost of goods sold. Such write-downs were $0.5 million and $1.2 million for the years ended December 31, 2016 and 2015 , respectively. The non-current portion of inventory is recorded within Other long-term assets on the accompanying Consolidated Balance Sheets and is comprised of a portion of the active pharmaceutical ingredient that is included in raw materials and work in process inventories. |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2016 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | PROPERTY AND EQUIPMENT Property and equipment consisted of the following (in thousands): December 31, 2016 2015 Laboratory equipment $ 4,310 $ 4,749 Computer equipment and software 13,738 11,890 Furniture and fixtures 2,240 2,253 Leasehold improvements 6,646 6,395 Construction-in-progress 19 456 26,953 25,743 Less: accumulated depreciation and amortization (24,882 ) (24,309 ) Property and equipment, net $ 2,071 $ 1,434 For the years ended December 31, 2016 , 2015 and 2014 , we recorded depreciation expense of $1.0 million , $1.4 million and $2.4 million , respectively. For the year ended 2014, we recorded an asset impairment charge of $0.7 million in connection with the Restructurings. There were no such charges in 2016 or 2015 . In 2015 and 2014, the gain on the sale of excess equipment was $1.0 million and $0.6 million , respectively. There were no such gains in 2016. Cash proceeds on sales were $0.1 million , $1.3 million and $0.4 million during 2016, 2015 and 2014 , respectively. The impairment and subsequent sale of excess equipment was a result of the 2010 restructurings, as described further in “Note 3 - Restructurings”. The asset impairment charge, net of the gain on the sale of such assets was recorded as a Restructuring charge (recovery) in our Consolidated Statements of Operations. |
Debt
Debt | 12 Months Ended |
Dec. 31, 2016 | |
Debt Disclosure [Abstract] | |
Debt | DEBT The amortized carrying amount of our debt consists of the following (in thousands): December 31, 2016 2015 Secured Convertible Notes due 2018 (“Deerfield Notes”) $ 109,122 $ 102,727 Term loan payable 80,000 80,000 2019 Notes — 235,210 Total debt 189,122 417,937 Less: current portion (189,122 ) — Long-term debt $ — $ 417,937 Prior period balances in this Note reflect revisions due to a correction of an immaterial error with regards to the 2019 Notes. The immaterial error resulted in an overstatement of the discount on the 2019 Notes and therefore understated the amortized carrying amount of the 2019 Notes and overstated the related interest expense. See “Note 1. Organization and Summary of Significant Accounting Policies - Correction of an Immaterial Error” for additional information on the correction of the immaterial error. Deerfield Notes In June 2010, we entered into a note purchase agreement with Deerfield Private Design Fund, L.P. and Deerfield Private Design International, L.P., (the “Original Deerfield Purchasers”), pursuant to which, on July 1, 2010, we sold to the Original Deerfield Purchasers an aggregate of $124.0 million principal amount of our Secured Convertible Notes due July 1, 2015, which we refer to as the Original Deerfield Notes, for an aggregate purchase price of $80.0 million , less closing fees and expenses of approximately $2.0 million . On August 6, 2012, the parties amended the note purchase agreement to permit the issuance of the 2019 Notes and modify certain optional prepayment rights. The amendment became effective upon the issuance of the 2019 Notes and the payment to the Original Deerfield Purchasers of a $1.5 million consent fee. On August 1, 2013, the parties further amended the note purchase agreement to clarify certain of our other rights under the note purchase agreement. On January 22, 2014, the note purchase agreement was amended to provide us with an option to extend the maturity date of our indebtedness under the note purchase agreement to July 1, 2018. On July 10, 2014, the parties further amended the note purchase agreement to clarify certain technical provisions. On July 1, 2015, we made a $4.0 million principal payment and then extended the maturity date of the Original Deerfield Notes from July 1, 2015 to July 1, 2018. In connection with the extension, Deerfield Partners, L.P. and Deerfield International Master Fund, L.P. (the “New Deerfield Purchasers”) acquired the $100.0 million principal amount of the Original Deerfield Notes and we entered into the Restated Deerfield Notes with each of the New Deerfield Purchasers, representing the $100.0 million principal amount. We refer to the Original Deerfield Purchasers and the New Deerfield Purchasers collectively as Deerfield, and to the Original Deerfield Notes and Restated Deerfield Notes, collectively as the Deerfield Notes. As of December 31, 2016 and 2015 , the outstanding principal balance on the Deerfield Notes was $109.8 million and $103.8 million , respectively, which, subject to certain limitations, is payable in cash or in stock at our discretion. Beginning on July 2, 2015, the outstanding principal amount of the Deerfield Notes bears interest at the rate of 7.5% per annum to be paid in cash, quarterly in arrears, and 7.5% per annum to be paid in kind, quarterly in arrears, for a total interest rate of 15% per annum. Through July 1, 2015, the outstanding principal amount of the Deerfield Notes bore interest in the annual amount of $6.0 million , payable quarterly in arrears. We have classified the Deerfield Notes as a current liability as of December 31, 2016 because we intend to repay the Deerfield Notes on or about July 1, 2017 at a prepayment price equal to 105% of the outstanding principal amount of the notes, plus accrued and unpaid interest to the date of repayment. We expect that cash and cash equivalents and short-term investments held at December 31, 2016 will be used to repay the Deerfield Notes. The following is a summary of interest expense for the Deerfield Notes (in thousands): Year Ended December 31, 2016 2015 2014 Stated coupon interest $ 8,008 $ 6,792 $ 6,000 Interest paid in kind 8,008 3,817 — Amortization of debt discount and debt issuance costs 457 5,461 11,731 Total interest expense $ 16,473 $ 16,070 $ 17,731 The balance of unamortized fees and costs was $0.4 million and $0.7 million as of December 31, 2016 and 2015 , respectively, which is recorded as a reduction of the carrying amount of the Deerfield Notes on the accompanying Consolidated Balance Sheets. Effective March 4, 2015, upon notification of our election to extend the maturity date to July 1, 2018, we began to amortize the remaining unamortized discount, fees and costs through July 1, 2018 using the effective interest method and an effective interest rate of 15.2% . We were required to offer to make an additional mandatory prepayment on the Deerfield Notes in January 2016 and 2015 equal to 15% of certain revenues from collaborative arrangements, which we refer to as “Development/Commercialization Revenue”, received during the prior fiscal year, subject to a maximum prepayment amount of $27.5 million . The definition of Development/Commercialization Revenue expressly excludes any sale or distribution of drug or pharmaceutical products in the ordinary course of our business, and any proceeds from any Intellectual Property Sale, but would include our share of the net profits from the commercialization of cobimetinib in the U.S. and the receipt of royalties from cobimetinib sales outside the U.S. As a result of the extension of the maturity date of the Deerfield Notes to July 1, 2018, our obligation to make annual mandatory prepayments equal to 15% of Development/Commercialization Revenue received by us during the prior fiscal year will continue to apply in January 2017 and January 2018. We are only obligated to offer to make any such annual mandatory prepayment if the note holders provide notice to us of their election to receive the prepayment. We made no such mandatory prepayments due to the fact that Deerfield elected not to receive the mandatory prepayments in January 2017 or 2016 related to Development/Commercialization Revenue received during the years ended December 31, 2016 and 2015 and we received no such revenues during the fiscal year ended December 31, 2014. Under the note purchase agreement, we may at our sole discretion, prepay all of the principal amount of the Deerfield Notes at a prepayment price equal to 105% of the outstanding principal amount of the Deerfield Notes, plus all accrued and unpaid interest through the date of such prepayment, plus, if prior to July 1, 2017, all interest that would have accrued on the principal amount of the Deerfield Notes between the date of such prepayment and July 1, 2017, if the outstanding principal amount of the Deerfield Notes as of such prepayment date had remained outstanding through July 1, 2017, plus all other accrued and unpaid obligations, collectively referred to as the Prepayment Price. In lieu of making any portion of the Prepayment Price or mandatory prepayment in cash, subject to certain limitations (including a cap on the number of shares issuable under the note purchase agreement), we have the right to convert all or a portion of the principal amount of the Deerfield Notes into, or satisfy all or any portion of the Prepayment Price amounts or mandatory prepayment amounts with shares of our common stock. Additionally, in lieu of making any payment of accrued and unpaid interest in respect of the Deerfield Notes in cash, subject to certain limitations, we may elect to satisfy any such payment with shares of our common stock. The number of shares of our common stock issuable upon conversion or in settlement of principal and interest obligations will be based upon the discounted trading price of our common stock over a specified trading period. Upon certain changes of control of Exelixis, a sale or transfer of assets in one transaction or a series of related transactions for a purchase price of more than (i) $400 million or (ii) 50% of our market capitalization, Deerfield may require us to prepay the Deerfield Notes at the Prepayment Price. Upon an event of default, as defined in the Deerfield Notes, Deerfield may declare all or a portion of the Prepayment Price to be immediately due and payable. We are required to notify the applicable Deerfield entities of certain sales, assignments, grants of exclusive licenses or other transfers of our intellectual property pursuant to which we transfer all or substantially all of our legal or economic interests, defined as an Intellectual Property Sale, and the Deerfield entities may elect to require us to prepay the principal amount of the Deerfield Notes in an amount equal to (i) 100% of the cash proceeds of any Intellectual Property Sale relating to cabozantinib and (ii) 50% of the cash proceeds of any other Intellectual Property Sale. In connection with the January 2014 amendment to the note purchase agreement, on January 22, 2014, we issued to the New Deerfield Purchasers two -year warrants, which we refer to as the 2014 Warrants, to purchase an aggregate of 1,000,000 shares of our common stock at an exercise price of $9.70 per share. Subsequent to our election to extend the maturity date of the Deerfield Notes, the exercise price of the 2014 Warrants was reset to $3.445 per share and the term was extended by two years to January 22, 2018. See “Note 8. Common Stock and Warrants” for more information on the valuation of the 2014 Warrants. In connection with the note purchase agreement, 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 security agreement was amended to limit the extent to which voting equity interests in any of our foreign subsidiaries shall be secured assets. The note purchase agreement as amended and the security agreement include customary representations and warranties and covenants made by us, including restrictions on the incurrence of additional indebtedness. Silicon Valley Bank Loan and Security Agreement On May 22, 2002, we entered into a loan and security agreement with Silicon Valley Bank for an equipment line of credit. On December 21, 2004, December 21, 2006 and December 21, 2007, we amended the loan and security agreement to provide for additional equipment lines of credit and on June 2, 2010, we further amended the loan and security agreement to provide for a new seven -year term loan in the amount of $80.0 million . As of both December 31, 2016 and 2015, the outstanding principal balance due under the term loan was $80.0 million and the lines of credit had been repaid in full. The principal amount outstanding under the term loan accrues interest at 1.0% per annum, which interest is due and payable monthly. We are required to repay the term loan in one balloon principal payment, representing 100% of the principal balance and accrued and unpaid interest, on May 31, 2017. We have the option to prepay all, but not less than all, of the amounts advanced under the term loan, provided that we pay all unpaid accrued interest thereon that is due through the date of such prepayment and the interest on the entire principal balance of the term loan that would otherwise have been paid after such prepayment date until the maturity date of the term loan. In accordance with the terms of the loan and security agreement, we are required to maintain an amount equal to at least 100% , but not to exceed 107% , of the outstanding principal balance of the term loan under the loan and security agreement on deposit in one or more investment accounts with Silicon Valley Bank or one of its affiliates as support for our obligations under the loan and security agreement (although we are entitled to retain income earned or the amounts maintained in such accounts). Any amounts outstanding under the term loan during the continuance of an event of default under the loan and security agreement will, at the election of Silicon Valley Bank, bear interest at a per annum rate equal to 6.0% . If one or more events of default under the loan and security agreement occurs and continues beyond any applicable cure period, Silicon Valley Bank may declare all or part of the obligations under the loan and security agreement to be immediately due and payable and stop advancing money or extending credit to us under the loan and security agreement. The total collateral balance as of both December 31, 2016 and 2015 was $81.6 million and is reflected in our Consolidated Balance Sheet in Short-term investments and Long-term investments as the amounts are not restricted as to withdrawal. However, withdrawal of some or all of this amount such that the collateral balance falls below the required level could result in Silicon Valley Bank declaring the obligation immediately due and payable. 2019 Notes In August 2012 , we issued and sold $287.5 million aggregate principal amount of the 2019 Notes, for net proceeds of $277.7 million . The 2019 Notes bore interest at a rate of 4.25% per annum, payable semi-annually in arrears on February 15 and August 15 of each year. On August 9, 2016 and August 19, 2016 we entered into separate, privately negotiated exchange agreements with certain holders of the 2019 Notes. Under the terms of the exchange agreements, the holders agreed to exchange an aggregate principal amount of $239.4 million of 2019 Notes held by them for an aggregate of 45,064,455 shares of our common stock. In addition, the holders received inducements of $6.0 million which included an aggregate cash payment of $2.4 million and $3.6 million in interest payments payable on the Deerfield Notes on August 15, 2016. Under the terms of the indenture for the 2019 Notes, subject to certain exceptions, holders who convert between a record date and the related interest payment date would have been required to repay the interest payment received on the related interest payment date. The exchange transactions entered into on August 9, 2016 were structured such that the holders party to those agreements were not required to repay this interest. We have included those payments as an additional inducement and as financing activities in our Consolidated Statement of Cash Flows. Inducements are included in the loss on extinguishment of debt. Following the completion of the exchange transactions, on August 24, 2016, we provided public notice of the redemption of $48.1 million of the 2019 Notes, representing all remaining notes outstanding. During the redemption period, which ended on November 2, 2016, holders of the 2019 Notes had the option to convert their notes into shares of our common stock, plus cash in lieu of any fractional share, at a conversion rate of 188.2353 shares of common stock per $1,000 principal amount of the remaining 2019 Notes at any time before close of business on October 31, 2016. On various dates in August, September, October and November of 2016, subsequent to the announcement of the redemption of all remaining 2019 Notes outstanding, $47.5 million of additional aggregate principal amount of 2019 Notes were converted by the holders into an aggregate of 8,944,824 shares of our common stock. We recognized an additional loss on extinguishment of debt of $7.3 million , representing the difference between the total settlement consideration transferred to the holders that was attributed to the liability component of the 2019 Notes, based on the fair value of that component at the time of conversion, and the net carrying value of the liability. The combined issuance of 54,009,279 shares of our common stock pursuant to the conversions of the 2019 Notes resulted in an increase to common stock and additional paid-in capital of $592.7 million . A portion of the settlement consideration transferred was allocated to the reacquisition of the embedded conversion option, which resulted in a $342.7 million reduction of additional paid-in capital. In November 2016 we redeemed the remaining $0.6 million aggregate principal amount of the 2019 Notes in cash for 100% of the principal amount thereof, plus accrued and unpaid interest. Transaction costs incurred with third parties related to the conversion of the 2019 Notes were allocated between the liability and equity components and resulted in an additional $0.5 million of loss on extinguishment of debt and a $0.7 million reduction of additional paid-in capital. The following is a summary of loss on extinguishment of debt for the conversion and redemption of the 2019 Notes for the year ended December 31, 2016 (in thousands): Inducements included in August 9, 2016 and August 19, 2016 agreements: Cash inducements $ 2,394 Repayments of interest required upon a conversion under the terms of the indenture that were not repaid under the terms of the exchange agreements 3,572 Difference between the total settlement consideration attributed to the liability component of the 2019 Notes and the net carrying value of the liability, described above 7,338 Unamortized discount on redeemed notes 83 Third party costs 514 Loss on extinguishment of debt $ 13,901 The following is a summary of the interest expense for the 2019 Notes (in thousands): Year Ended December 31, 2016 2015 2014 Stated coupon interest $ 7,799 $ 12,218 $ 12,253 Amortization of debt discount and debt issuance costs 7,975 11,581 10,525 Total interest expense $ 15,774 $ 23,799 $ 22,778 The balance of unamortized fees and costs was $4.2 million as of December 31, 2015 which is recorded as a reduction of the carrying amount of the 2019 Notes on the accompanying Consolidated Balance Sheets. There were no such unamortized fees and costs as of December 31, 2016 due to the conversion and redemption of 100% of the 2019 Notes in 2016. Future Principal Payments Aggregate contractual future principal payments of our debt are as follows as of December 31, 2016 (in thousands): Year Ending December 31, (1) 2017 $ 80,000 2018 124,972 Thereafter — ____________________ (1) As described above, we intend to repay the Deerfield Notes, which have a contractual maturity of July 1, 2018, on or about July 1, 2017. The actual timing of payments may differ materially. |
Common Stock and Warrants
Common Stock and Warrants | 12 Months Ended |
Dec. 31, 2016 | |
Warrants and Rights Note Disclosure [Abstract] | |
Common Stock and Warrants | COMMON STOCK AND WARRANTS Conversion of Debt into Common Stock In 2016, we issued 54,009,279 shares of our common stock pursuant to the conversion of $286.9 million of aggregate principal amount of 2019 Notes. The conversions resulted in a $253.1 million increase to shareholder’s equity and a $13.9 million loss on extinguishment of debt. The Deerfield Notes are, under certain circumstances, convertible into shares of our common stock. See “Note 7. Debt” for more information regarding the conversion features of these instruments. Sale of Shares of Common Stock In July 2015, we completed a registered underwritten public offering of 28,750,000 shares of our common stock, including 3,750,000 shares issued under the underwriters’ 30-day option to buy shares, at a price of $5.40 per share pursuant to a shelf registration statement previously filed with the SEC, which was filed and automatically became effective on July 1, 2015. We received $145.6 million in net proceeds from the offering after deducting the underwriting discount and other estimated expenses. In January 2014, we completed a registered underwritten public offering of 10,000,000 shares of our common stock at a price of $8.00 per share pursuant to a shelf registration statement previously filed with the SEC, which the SEC declared effective on June 8, 2012. We received $75.6 million in net proceeds from the offering after deducting the underwriting discount and related offering expenses. 2014 Warrants In connection with an amendment to the note purchase agreement for the Original Deerfield Notes, in January 2014 we issued to the New Deerfield Purchasers two -year warrants to purchase an aggregate of 1,000,000 shares of our common stock at an exercise price of $9.70 per share. Subsequent to our March 2015 notification of our election to extend the maturity date of the Deerfield Notes, the exercise price of the 2014 Warrants was reset to $3.445 per share and the term was extended by two years to January 22, 2018. The 2014 Warrants contain certain limitations that prevent the holder from acquiring shares upon exercise that would result in the number of shares beneficially owned by the holder to exceed 9.98% of the total number of shares of our common stock then issued and outstanding. In addition, upon certain changes in control of Exelixis, to the extent the 2014 Warrants are not assumed by the acquiring entity, or upon certain defaults under the 2014 Warrants, the holder has the right to net exercise the 2014 Warrants for shares of common stock, or be paid an amount in cash in certain circumstances where the current holders of our common stock would also receive cash, equal to the Black-Scholes Merton value of the 2014 Warrants. In connection with the issuance of the 2014 Warrants, we entered into a registration rights agreement with Deerfield, pursuant to which we filed a registration statement with the SEC covering the resale of the shares of common stock issuable upon exercise of the 2014 Warrants. Due to the potential increase in term and decrease of the exercise price, the 2014 Warrants were included in Other long-term liabilities at their current estimated fair value, which was $1.5 million and $0.9 million as of March 18, 2015 and December 31, 2014, respectively. We recorded an unrealized loss of $0.5 million and an unrealized gain of $1.8 million on the 2014 Warrants during the years ended December 31, 2015 and 2014, respectively, which is included in Interest income and other, net. Subsequent to our March 2015 notification of our election to extend the maturity date of the Deerfield Notes, the terms of the 2014 Warrants became fixed as of March 18, 2015 and the 2014 Warrants were transferred to Additional paid-in capital as of that date at their then estimated fair value of $1.5 million . The warrants are participating securities however the holders do not have a contractual obligation to share in our losses; thus, they have been excluded from our net loss per share calculations. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2016 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | FAIR VALUE MEASUREMENTS The following table sets forth the fair value of our financial assets that were measured and recorded on a recurring basis as of December 31, 2016 and 2015 . We did not have any Level 3 investments as of December 31, 2016 or 2015 . The amounts presented exclude cash, but include investments classified as cash equivalents (in thousands): December 31, 2016 Level 1 Level 2 Total Money market funds $ 71,457 $ — $ 71,457 Commercial paper — 165,375 165,375 Corporate bonds — 152,407 152,407 U.S. Treasury and government sponsored enterprises — 70,727 70,727 Total financial assets $ 71,457 $ 388,509 $ 459,966 December 31, 2015 Level 1 Level 2 Total Money market funds $ 72,000 $ — $ 72,000 Commercial paper — 78,155 78,155 Corporate bonds — 72,091 72,091 U.S. Treasury and government sponsored enterprises — 28,423 28,423 Marketable equity securities 18 — 18 Total financial assets $ 72,018 $ 178,669 $ 250,687 The following is a reconciliation of changes in the fair value of warrants which are classified as Level 3 in the fair value hierarchy (in thousands) : Balance at December 31, 2014 $ 921 Unrealized loss at final re-measurement of warrants on March 18, 2015, included in Interest income and other, net 549 Transfer of warrants from Other long-term liabilities to Additional paid-in capital at their estimated fair value upon warrant repricing on March 18, 2015 (1,470 ) Balance at December 31, 2015 $ — No such activity occurred during the year ended December 31, 2016. The estimated fair value of our financial instruments that are carried at amortized cost is as follows (in thousands) : December 31, 2016 December 31, 2015 Carrying Amount Fair Value Carrying Amount Fair Value Deerfield Notes $ 109,122 $ 121,220 $ 102,727 $ 101,096 Term loan payable $ 80,000 $ 79,784 $ 80,000 $ 79,815 2019 Notes $ — $ — $ 235,210 $ 336,260 The carrying amounts of cash, trade and other receivables, accounts payable, accrued collaboration liability, accrued clinical trial liabilities, accrued compensation and benefits, and other 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 were 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 were 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 (deficit) on the accompanying Consolidated Balance Sheets. • We estimate the fair value of our other debt instruments, where possible, using the net present value of the payments. For the Silicon Valley Bank term loan and line of credit, we use an interest rate that is consistent with money-market rates that would have been earned on our non-interest-bearing compensating balances as our discount rate, which is a Level 2 input. For the Deerfield Notes, we used a discount rate of 9.5% , which we estimate as our current borrowing rate for similar debt as of December 31, 2016 , which is a Level 3 input. Financial Assets, Liabilities and Equity Measured on a Nonrecurring Basis In connection with the conversions for our 2019 Note during 2016, we were required to determine the fair value of the settlement consideration received by the holders and the fair value of the liability component of the 2019 Notes, as of the various settlement dates of the conversions. The following methods and assumptions were used to estimate the fair value of those financial instruments: • The settlement consideration comprises, in part, shares of our Common Stock. The fair value of our Common Stock was determined based on the closing market price of our Common Stock on the various settlement dates of the conversions, which are level 1 inputs; • The carrying value of the remaining settlement consideration, which includes cash and the forgiveness of the repayment of certain prior interest payments, approximates fair value; • We estimated the fair value of the liability component of the 2019 Notes using the net present value of estimated future cash flows through maturity. We used a discount rate of 9.5% , which we estimated as our current borrowing rate for straight debt as of September 30, 2016, which is a Level 3 input. |
Employee Equity and Benefit Pla
Employee Equity and Benefit Plans | 12 Months Ended |
Dec. 31, 2016 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Employee Equity and Benefit Plans | EMPLOYEE EQUITY AND BENEFIT PLANS Equity Incentive Plans We have several equity incentive plans under which we have granted incentive stock options, non-qualified stock options and RSUs to employees, directors and consultants. The Board of Directors or a designated Committee of the Board is responsible for administration of our employee equity incentive plans and determines the term, exercise price and vesting terms of each option. Stock options have a four -year vesting term, an exercise price equal to the fair market value on the date of grant, and a seven year life from the date of grant. Stock options issued prior to May 2011 have a ten year life from the date of grant. RSUs granted to our employees vest annually over a four year term. In December 2005, our Board of Directors adopted a Change in Control and Severance Benefit Plan for executives and certain non-executives. Eligible Change in Control and Severance Benefit Plan participants include our employees with the title of vice president and above. If a participant’s employment is terminated without cause during a period commencing one month before and ending thirteen months following a change in control, as defined in the plan document, then the Change in Control and Severance Benefit Plan participant is entitled to have the vesting of all of such participant’s stock options accelerated with the exercise period being extended to no more than one year . Employee Stock Purchase Plan In January 2000, we adopted the 2000 Employee Stock Purchase Plan (the “ESPP”). The ESPP allows for qualified employees (as defined in the ESPP) to purchase shares of our common stock at a price equal to the lower of 85% of the closing price at the beginning of the offering period or 85% of the closing price at the end of each six month purchase period. Compensation expense related to our ESPP was $1.0 million , $0.4 million , and $0.8 million for the years ended December 31, 2016 , 2015 and 2014 , respectively. As of December 31, 2016 , we had 5,487,023 shares available for issuance under our ESPP. We issued 559,936 shares, 324,315 shares, and 669,565 shares of common stock during the years ended December 31, 2016 , 2015 and 2014 , respectively, pursuant to the ESPP at an average price per share of $3.91 , $1.75 and $2.14 , respectively. Stock-Based Compensation We recorded and allocated employee stock-based compensation expense for our equity incentive plans and our ESPP as follows (in thousands): Year Ended December 31, 2016 2015 2014 Research and development expense $ 9,366 $ 11,691 $ 3,245 Selling, general and administrative expense 13,546 10,286 6,783 Restructuring related recovery — — (22 ) Total employee stock-based compensation expense $ 22,912 $ 21,977 $ 10,006 We use the Black-Scholes Merton option pricing model to value our stock options. The weighted average grant-date fair value of our stock options and ESPP purchases was as follows: 2016 2015 2014 Stock options $ 4.77 $ 2.55 $ 1.46 ESPP $ 2.17 $ 1.20 $ 1.28 The fair value of employee stock option awards and ESPP purchases was estimated using the following assumptions: Stock Options 2016 2015 2014 Risk-free interest rate 1.15 % 1.22 % 1.80 % Dividend yield — % — % — % Volatility 76 % 93 % 85 % Expected life 4.4 years 4.5 years 5.5 years ESPP 2016 2015 2014 Risk-free interest rate 0.55 % 0.15 % 0.06 % Dividend yield — % — % — % Volatility 65 % 98 % 69 % Expected life 6 months 6 months 6 months The expected life computation for stock options is based on historical exercise patterns and post-vesting termination behavior. We considered implied volatility as well as our historical volatility in developing our estimate of expected volatility. A summary of all stock option activity for the year ended December 31, 2016 is presented below (dollars in thousands , except per share amounts): Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term Aggregate Intrinsic Value Options outstanding at December 31, 2015 27,425,854 $ 4.22 Granted 4,200,950 $ 8.29 Exercised (6,239,022 ) $ 4.07 Forfeited (307,601 ) $ 4.67 Expired (80,516 ) $ 10.49 Options outstanding at December 31, 2016 24,999,665 $ 4.91 4.54 years $ 250,996 Exercisable at December 31, 2016 17,731,361 $ 4.01 3.98 years $ 193,288 At December 31, 2016 , a total of 1,630,271 shares were available for grant under our stock option plans. The aggregate intrinsic value in the table above represents the total intrinsic value (the difference between our closing stock price on the last trading day of fiscal 2016 and the exercise prices, multiplied by the number of in-the-money options) that would have been received by the option holders had all option holders exercised their options on December 31, 2016 . The total intrinsic value of options exercised was $50.0 million and $2.9 million during the years ended December 31, 2016 and 2015 , respectively, and was nominal in 2014 . The total estimated fair value of employee options vested and recorded as expense during the years ended December 31, 2016 , 2015 and 2014 was $13.4 million , $18.9 million and $8.6 million , respectively. On April 28, 2016, as a result of the FDA’s approval of our New Drug Application “NDA” submission, on March 7, 2016, as a result of the FDA’s acceptance of our NDA submission and on July 20, 2015, as a result of positive top-line results from the primary analysis of METEOR, the Compensation Committee of the Board of Directors of Exelixis convened to determine we had met certain performance objectives for performance-based stock options granted to employees in 2013, 2014 and 2015. As a result of these determinations, 5,870,303 and 6,982,613 performance-based stock options vested during the years ended December 31, 2016 and 2015 , respectively . During the years ended December 31, 2016 and 2015 we recognized $4.1 million and $13.2 million in stock-based compensation expense for those performance-based stock option grants . Prior to 2015, we had not considered achievement of those performance objectives to be probable and therefore, we did no t record any stock-based compensation expense for the performance-based stock options during 2014. The following table summarizes information about stock options outstanding and exercisable at December 31, 2016 : Options Outstanding Options Outstanding and Exercisable Exercise Price Range Number Weighted Average Remaining Contractual Life Weighted Average Exercise Price Number Exercisable Weighted Average Exercise Price $1.46 - $1.90 8,231,617 4.64 years $ 1.77 8,088,721 $ 1.77 $2.57 - $4.05 2,707,474 5.57 years $ 3.56 1,130,251 $ 3.27 $4.16 - $5.55 5,957,725 3.58 years 3,186,063 $ 5.18 4,520,554 $ 5.31 $5.61 - $6.21 4,076,881 6,881 5.17 years $ 6.08 1,861,457 $ 6.00 $6.25 - $18.25 4,025,968 4.42 years $ 10.67 2,130,378 $ 8.42 24,999,665 4.54 years $ 4.91 17,731,361 $ 4.01 As of December 31, 2016 , $23.9 million of total unrecognized compensation expense related to stock options is expected to be recognized over a weighted-average period of 2.90 years . Cash received from option exercises and purchases under the ESPP in the years ended December 31, 2016 , 2015 and 2013 was $27.5 million , $11.5 million and $1.6 million , respectively. The fair value of RSUs is determined based on the value of the underlying common stock on the date of grant. The expenses relating to these RSUs will be recognized over their respective vesting periods. A summary of all RSU activity was as follows for all periods presented (dollars in thousands, except per share amounts): Shares Weighted Average Grant Date Fair Value Weighted Average Remaining Contractual Term Aggregate Intrinsic Value Awards outstanding at December 31, 2015 1,002,188 $ 5.16 Awarded 3,138,236 $ 7.58 Vested and released (1,640,324 ) $ 4.49 Forfeited (30,309 ) $ 4.77 Awards outstanding at December 31, 2016 2,469,791 $ 8.69 1.93 years $ 36,825 As of December 31, 2016 , $13.9 million of total unrecognized compensation expense related to employee RSUs was expected to be recognized over a weighted-average period of 3.28 years . 401(k) Retirement Plan We sponsor a 401(k) Retirement Plan (the “401(k) Plan”) whereby eligible employees may elect to contribute up to the lesser of 50% of their annual compensation or the statutorily prescribed annual limit allowable under Internal Revenue Service regulations. The 401(k) Plan permits us to make matching contributions on behalf of all participants. We matched 100% of the first 3% of participant contributions into the 401(k) Plan in the form of our common stock. We recorded expense of $1.1 million , $0.4 million , and $1.1 million related to the stock match for the years ended December 31, 2016 , 2015 and 2014 , respectively. As of December 31, 2016 , we had 303,187 shares available for issuance under our 401(k) Plan . |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2016 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | INCOME TAXES The income tax (benefit) provision is based on the following loss before income taxes (in thousands): Year Ended December 31, 2016 2015 2014 Domestic $ (70,222 ) $ (150,846 ) $ (230,535 ) Foreign — (10,843 ) (30,944 ) Total $ (70,222 ) $ (161,689 ) $ (261,479 ) Income tax expense (benefit) consists of the following for the periods shown below (in thousands): Year Ended December 31, 2016 2015 2014 Current: Federal $ — $ — $ — State — 55 (182 ) Total current tax expense — 55 (182 ) Deferred: Federal — — — State — — — Total deferred tax expense — — — Income tax provision (benefit) $ — $ 55 $ (182 ) The 2016 income tax provision relates to state minimum and franchise taxes and were nominal. The 2015 income tax provision relates to state minimum and franchise tax expenses as well as true ups related to prior year tax entries. The 2014 income tax benefit resulted from the lapse of the applicable statute of limitations in California for the 2009 tax year, offset by current year state income tax expense. A reconciliation of income taxes at the statutory federal income tax rate to our income tax (benefit) provision included in the Consolidated Statements of Operations is as follows (in thousands): Year Ended December 31, 2016 2015 2014 U.S. federal income tax benefit at statutory rate $ (23,876 ) $ (54,974 ) $ (88,903 ) Unutilized net operating losses 6,377 51,421 84,985 State tax expense 6,520 55 (182 ) Debt extinguishment 4,726 — — Non-deductible interest 2,680 3,308 3,598 Stock-based compensation 3,155 195 255 Other 418 50 65 Income tax (benefit) provision $ — $ 55 $ (182 ) Deferred tax assets and liabilities reflect the net tax effects of net operating loss and tax credit carry-forwards and temporary differences between the carrying amounts of assets and liabilities for financial reporting and the amounts used for income tax purposes. Our deferred tax assets and liabilities consist of the following (in thousands): December 31, 2016 2015 Deferred tax assets: Net operating loss carry-forwards $ 471,327 $ 464,504 Book over tax depreciation and amortization 70,617 1,752 Tax credit and charitable contribution carry-forwards 64,367 64,350 Amortization of deferred stock compensation – non-qualified 14,780 14,615 Accruals and reserves not currently deductible 8,117 7,775 Other 106 — Total deferred tax assets 629,314 552,996 Valuation allowance (629,062 ) (536,327 ) Net deferred tax assets 252 16,669 Deferred tax liabilities: Unrealized gain on derivatives (252 ) (497 ) Convertible debt — (16,172 ) Total deferred tax liabilities (252 ) (16,669 ) Net deferred taxes $ — $ — Accounting Standards Codification 740 requires that the tax benefit of net operating losses, temporary differences and credit carry forwards be recorded as an asset to the extent that management assesses that realization is "more likely than not." Realization of the future tax benefits is dependent on the Company's ability to generate sufficient taxable income within the carry forward period. Because of the Company's recent history of operating losses, management believes that recognition of the deferred tax assets arising from the above-mentioned future tax benefits is currently not likely to be realized and, accordingly, has provided a valuation allowance. The valuation allowance increased by $92.7 million , $7.9 million and $88.8 million during 2016, 2015 and 2014, respectively. At December 31, 2016, we had federal net operating loss carry-forwards of approximately $1,424 million which expire in the years 2019 through 2036 , and federal business tax credits of approximately $75 million which expire in the years 2020 through 2029 . We also had state net operating loss carry-forwards of approximately $494 million , which expire in the years 2017 through 2036 , California research and development tax credits of approximately $25 million which have no expiration. Included in the federal and state carry-forwards is $56.9 million related to deductions from the exercise of stock options and the related tax benefit that will result in an increase in additional paid-in capital if and when realized through a reduction of taxes paid in cash. Under the Internal Revenue Code and similar state provisions, certain substantial changes in our ownership could result in an annual limitation on the amount of net operating loss and credit carry-forwards that can be utilized in future years to offset future taxable income. The annual limitation may result in the expiration of net operating losses and credit carry-forwards before utilization. We completed a Section 382 study through December 31, 2016, and concluded that an ownership change, as defined under Section 382, had not occurred. Accounting Standards Codification Topic 740-10 clarifies the accounting for uncertainty in income taxes by prescribing the recognition threshold a tax position is required to meet before being recognized in the financial statements. It also provides guidance on derecognition, classification, interest and penalties, accounting in interim periods, disclosure and transition. The following table summarizes the activity related to our unrecognized tax benefits (in thousands): Year Ended December 31, 2016 2015 2014 Beginning balance $ 88,638 $ 58,215 $ 55,077 Decrease (increase) relating to prior year provision (29,110 ) 21,696 719 Increase relating to current year provision 2,304 8,727 2,706 Reductions based on the lapse of the applicable statutes of limitations (23 ) — (287 ) Ending balance $ 61,809 $ 88,638 $ 58,215 We do not anticipate that the amount of unrecognized tax benefits existing as of December 31, 2016 will significantly decrease over the next 12 months. We file U.S. and state income tax returns in jurisdictions with varying statues of limitations during which such tax returns may be audited and adjusted by the relevant tax authorities. The 1999 through 2015 years generally remain subject to examination by federal and most state tax authorities to the extent of net operating losses and credits generated during these periods and are being utilized in the open tax periods. |
Net Loss Per Share
Net Loss Per Share | 12 Months Ended |
Dec. 31, 2016 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | NET LOSS PER SHARE The following table sets forth a reconciliation of basic and diluted net loss per share (in thousands, except per share amounts): Year Ended December 31, 2016 2015 2014 Numerator: Net loss $ (70,222 ) $ (161,744 ) $ (261,297 ) Denominator: Shares used in computing basic and diluted net loss per share 250,531 209,227 194,299 Net loss per share, basic and diluted $ (0.28 ) $ (0.77 ) $ (1.34 ) The following table sets forth outstanding potential shares of common stock outstanding as of the dates presented that are not included in the computation of diluted net loss per share because to do so would be anti-dilutive (in thousands): December 31, 2016 2015 2014 Convertible debt 33,890 88,008 75,734 Outstanding stock options, unvested RSUs and ESPP contributions 27,568 28,470 28,930 Warrants 1,000 1,000 1,000 Total potentially dilutive shares 62,458 117,478 105,664 |
Commitments
Commitments | 12 Months Ended |
Dec. 31, 2016 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments | COMMITMENTS Leases We lease office and research space under operating leases that expire at various dates through the year 2018. Certain operating leases contain renewal provisions and require us to pay other expenses. Aggregate future minimum lease payments under our operating leases are as follows (in thousands): Year Ending December 31, Operating Leases (1) 2017 8,474 2018 3,007 $ 11,481 ____________________ (1) Minimum payments have not been reduced by minimum sublease rentals of $1.2 million due in the future under noncancelable subleases. The following is a summary of aggregate future minimum lease payments under operating leases at December 31, 2016 , by operating lease agreements (in thousands): Original Term (Expiration) Renewal Options Future Minimum Lease Payments Building Lease #1 and 2 May 2017 none $ 3,425 Building Lease #3 July 2018 1 additional period of 5 years 8,056 Total $ 11,481 Rent expense under operating leases was $6.1 million , $8.7 million , and $10.3 million for the years ended December 31, 2016 , 2015 and 2014 , respectively. Rent expense was recorded net of sublease rental incomes of $3.6 million , $5.2 million and $4.9 million for the years ended December 31, 2016 , 2015 and 2014 , respectively. Letters of Credit and Restricted Cash We entered into a standby letter of credit with a bank in July 2004, which is related to a building lease, with a credit limit of $0.5 million at both December 31, 2016 and 2015 . We entered into two standby letters of credit with a bank in May 2007, which is related to our workers compensation insurance policy, for a combined credit limit of $0.6 million at both December 31, 2016 and 2015 . All three letters of credit are fully collateralized by long-term restricted cash and investments. As of December 31, 2016 , the full amount of our three letters of credit was available. As part of a purchasing card program with a bank we initiated during 2007, we were required to provide collateral in the form of a non-interest bearing certificate of deposit. The collateral at December 31, 2016 and 2015 was $3.0 million and $1.5 million , respectively. We recorded these amounts in the Consolidated Balance Sheet as Long-term restricted cash and investments as the certificates of deposit were restricted as to withdrawal. Indemnification Agreements In connection with the sale of our plant trait business, we agreed to indemnify the purchaser and its affiliates up to a specified amount if they incur damages due to any infringement or alleged infringement of certain patents. We have certain collaboration licensing agreements that contain standard indemnification clauses. Such clauses typically indemnify the customer or vendor for an adverse judgment in a lawsuit in the event of our misuse or negligence. We consider the likelihood of an adverse judgment related to any of our indemnification agreements to be remote. Furthermore, in the event of an adverse judgment, any losses under such an adverse judgment may be substantially offset by applicable corporate insurance. |
Concentrations of Credit Risk
Concentrations of Credit Risk | 12 Months Ended |
Dec. 31, 2016 | |
Risks and Uncertainties [Abstract] | |
Concentrations of Credit Risk | CONCENTRATIONS OF CREDIT RISK Financial instruments that potentially subject us to concentrations of credit risk are primarily trade and other receivables and investments. Investments consist of money market funds, taxable commercial paper, corporate bonds with high credit quality, and U.S. Treasury and 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 December 31, 2016 , 27% , 19% , 16% and 13% of our trade receivables are with Diplomat Specialty Pharmacy, Caremark L.L.C., affiliates of McKesson Corporation, and Accredo Health, Incorporated, respectively. All of these customers have historically paid promptly. As of December 31, 2016 , we also had a receivable for a $10.0 million milestone payment from Ipsen which we received subsequent to December 31, 2016. The following table sets forth the percentage of revenues recognized by customer that represent 10% or more of total revenues: Year Ended December 31, 2016 2015 2014 Diplomat Specialty Pharmacy 33 % 83 % 99 % Ipsen 17 % — % — % We have operations solely in the U.S., while some of our collaboration partners have headquarters outside of the U.S. and some of our clinical trials for cabozantinib are also conducted outside of the U.S. All of our long-lived assets are located in the U.S. The following table shows the revenues earned by geographic region. Net product revenues are attributed to regions based on ship-to location. Collaboration revenues are attributed to regions based on the location of the collaboration partner (dollars in thousands): Year Ended December 31, 2016 2015 2014 U.S. $ 140,709 $ 33,869 $ 24,832 Europe 35,745 3,303 279 Rest of world 15,000 — — We recorded a $0.2 million loss, a $0.1 million gain and a $0.5 million gain relating to foreign exchange fluctuations for the years ended December 31, 2016 , 2015 and 2014 , respectively. |
Subsequent Event
Subsequent Event | 12 Months Ended |
Dec. 31, 2016 | |
Subsequent Events [Abstract] | |
Subsequent Event | SUBSEQUENT EVENT On January 30, 2017, we entered into a collaboration and license agreement (the “Takeda Collaboration Agreement”) with Takeda Pharmaceutical Company Limited (“Takeda”) for the commercialization and further clinical development of cabozantinib in Japan. Pursuant to the terms of the Takeda Collaboration Agreement, Takeda will have exclusive commercialization rights for current and potential future cabozantinib indications in Japan. The companies have also agreed to collaborate on the future clinical development of cabozantinib in Japan. The parties’ efforts will be governed through a joint executive committee and appropriate subcommittees established to guide and oversee the collaboration’s operation and strategic direction. In consideration for the exclusive license and other rights contained in the Takeda Collaboration Agreement, Takeda paid us an upfront payment of $50.0 million in February 2017. We will be eligible to receive development, regulatory and first-sales milestones of up to $95.0 million related to second-line RCC, first-line RCC and second-line HCC, as well as additional development, regulatory and first-sales milestone payments for potential future indications. The Takeda Collaboration Agreement also provides that we will be eligible to receive pre-specified payments of up to $83.0 million associated with potential sales milestones. We will also receive royalties on net sales of cabozantinib in Japan at an initial tiered rate of 15% to 24% on net sales for the first $300.0 million of cumulative net sales. Thereafter, the royalty rate will be adjusted to 20% to 30% on annual net sales. Takeda will be responsible for 20% of the costs associated with the global cabozantinib development plan, provided Takeda opts in to participate in such trials, and 100% of costs associated with the cabozantinib development activities that are exclusively for the benefit of Japan. Pursuant to the terms of the Takeda Collaboration Agreement, we will remain responsible for the manufacture and supply of cabozantinib for all development and commercialization activities under the collaboration. As part of the collaboration, the parties will enter into a supply agreement covering the manufacture and supply of cabozantinib to Takeda and a quality agreement setting forth in detail the quality assurance arrangements and procedures for our manufacture of cabozantinib. The Takeda Collaboration Agreement may be terminated for cause by either party based on uncured material breach by the other party, bankruptcy of the other party or for safety reasons. For clarity, Takeda’s failure to achieve specified levels of commercial performance, based upon sales volume and/or promotional effort, during the first six years of the collaboration shall constitute a material breach of the Collaboration Agreement. We may terminate the agreement if Takeda challenges or opposes any patent covered by the Collaboration Agreement. At any time prior to August 1, 2023, the parties may mutually agree to terminate the Collaboration Agreement if Japan’s Pharmaceuticals and Medical Devices Agency is unlikely to grant approval of the marketing authorization application in any cancer indication in Japan. After the commercial launch of cabozantinib in Japan, Takeda may terminate the Collaboration Agreement upon twelve months’ prior written notice following the third anniversary of the first commercial sale of cabozantinib in Japan. Upon termination by either party, all licenses granted by us to Takeda will automatically terminate, and the licenses granted by Takeda to us shall survive such termination and shall automatically become worldwide. |
Quarterly Financial Data (Unaud
Quarterly Financial Data (Unaudited) | 12 Months Ended |
Dec. 31, 2016 | |
Quarterly Financial Information Disclosure [Abstract] | |
Quarterly Financial Data (Unaudited) | QUARTERLY FINANCIAL DATA (UNAUDITED) The following tables summarize the unaudited quarterly financial data for the last two fiscal years (in thousands, except per share data): Quarter Ended December 31, September 30, June 30, March 31, 2016: Revenues $ 77,581 $ 62,194 $ 36,252 $ 15,427 Gross profit $ 50,064 $ 40,287 $ 30,058 $ 8,414 Income (loss) from operations $ 38,883 $ 7,264 $ (25,136 ) $ (49,135 ) Net income (loss) $ 35,123 $ (11,284 ) $ (34,838 ) $ (59,223 ) Net income (loss) per share, basic and diluted $ 0.12 $ (0.04 ) $ (0.15 ) $ (0.26 ) 2015: Revenues $ 9,938 $ 9,854 $ 7,992 $ 9,388 Gross profit $ 8,915 $ 8,434 $ 7,306 $ 8,622 Loss from operations $ (31,600 ) $ (35,781 ) $ (31,280 ) $ (22,760 ) Net loss (1) $ (41,568 ) $ (45,542 ) $ (41,389 ) $ (33,245 ) Net loss per share, basic and diluted (1) $ (0.18 ) $ (0.21 ) $ (0.21 ) $ (0.17 ) ____________________ (1) Prior period balances reflect revisions due to a correction of an immaterial error with regards to the 2019 Notes. The immaterial error resulted in an overstatement of the discount on the 2019 Notes and therefore overstated the related interest expense. Therefore, net loss was overstated by $2.2 million , $2.1 million , $2.1 million , $2.0 million , $2.0 million , $1.9 million for the quarters ended June 30 2016 and March 31, 2016, December 31, 2015, September 30, 2015, June 30 2015 and March 31, 2015, respectively, and net loss per share, basic and diluted was overstated by $0.01 , for each of those quarters. See “Note 1. Organization and Summary of Significant Accounting Policies - Correction of an Immaterial Error” for additional information on the correction of the immaterial error. The increase in revenues and gross profit for the quarters ended December 31, 2016, September 30, 2016 and June 30, 2016 reflects the impact of the commercial launch of CABOMETYX in late April 2016. Revenues during 2016 also reflect license revenue for the amortization of deferred revenue on the collaboration and license agreement with Ipsen; the deferred revenue for the agreement relates to the upfront payment of $200.0 million received in the first quarter of 2016, the $60.0 million milestone we achieved upon the approval of cabozantinib by the EC in second-line RCC, and the $10.0 million upfront payment received in December 2016 in consideration for the commercialization rights in Canada. Total revenues also include two $10.0 million milestones achieved during the quarter ended December 31, 2016 for the first commercial sales of CABOMETYX by Ipsen in Germany and the United Kingdom, a $15.0 million milestone achieved during the quarter ended September 30, 2016 under our collaboration agreement with Daiichi Sankyo and a $5.0 million milestone achieved during the quarter ended March 31, 2016 under our collaboration agreement with Merck. See “Note 2. Collaboration Agreements” for more information on these collaboration agreements. As described further in “Note 2. Collaboration Agreements - Genentech Collaboration”, in December 2016 Genentech stated that it changed, both retroactively and prospectively, the manner in which it allocates promotional expenses of the Cotellic plus Zelboraf combination therapy. As a result of Genentech’s decision to change its cost allocation approach, we are relieved of our obligation to pay $18.7 million of disputed costs that had been accrued by us as of September 30, 2016. We have invoiced Genentech for certain expenses, with interest, that we had previously paid. Accordingly, during the quarter ended December 31, 2016, we offset Selling, general and administrative expenses for a $23.1 million recovery of net losses, which had been recorded from 2013 through September 30, 2016, including $13.3 million for losses that we had recognized and recorded prior to 2016. |
Organization and Summary of S25
Organization and Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2016 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Basis of Consolidation | Basis of Consolidation The consolidated financial statements include the accounts of Exelixis and those of our wholly-owned subsidiaries. These entities’ functional currency is the U.S. dollar. All intercompany balances and transactions have been eliminated. |
Basis of Presentation | Basis of Presentation We have adopted a 52- or 53-week fiscal year policy that generally ends on the Friday closest to December 31st. Fiscal year 2014, a 53-week year, ended on January 2, 2015; fiscal year 2015, a 52-week year, ended on January 1, 2016; fiscal year 2016, a 52-week year, ended on December 30, 2016; and fiscal year 2017, a 52-week year, will end on December 29, 2017. For convenience, references in this report as of and for the fiscal years ended January 2, 2015, January 1, 2016, and December 30, 2016 are indicated as being as of and for the years ended December 31, 2014, 2015, and 2016, respectively. The quarterly period ended January 2, 2015 is a 14-week fiscal quarter; all other interim periods presented are 13-week fiscal quarters. |
Use of Estimates | Use of Estimates The preparation of our consolidated financial statements is in conformity with accounting principles generally accepted in the United States (“U.S.”) which requires management to make judgments, estimates and assumptions that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosures. On an ongoing basis, management evaluates its estimates including, but not limited to, those related to revenue recognition, including deductions from revenues (such as rebates, chargebacks, sales returns and sales allowances), the period of performance, identification of deliverables and evaluation of milestones with respect to our collaborations, the amounts of revenues and expenses under our profit and loss sharing agreement, recoverability of inventory, certain accrued liabilities including the accrued clinical trial liability, the valuation of the debt and equity components of our convertible debt and stock-based compensation. We base our estimates on historical experience and on various other market-specific and other relevant assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results could differ materially from those estimates. |
Correction of an Immaterial Error | Correction of an Immaterial Error During the third quarter of 2016, we identified errors in the Consolidated Balance Sheets and Consolidated Statements of Operations, Comprehensive Loss and Cash Flows for 2015, 2014, 2013, and 2012, and in the unaudited interim Condensed Consolidated Balance Sheets and Condensed Consolidated Statements of Operations, Comprehensive Loss and Cash Flows for all prior interim fiscal periods from September 30, 2012 through June 30, 2016. Specifically, in 2012 we incorrectly calculated 1) the allocation between Additional paid-in capital and Convertible notes of the $287.5 million aggregate principal amount from our 4.25% Convertible Senior Subordinated Notes due 2019 (“2019 Notes”); and 2) the amortization of the debt discount associated with the 2019 Notes during 2012 and all subsequent periods. Having evaluated the materiality of these errors from a quantitative and qualitative perspective, management concluded that although the accumulation of these errors was significant to the three and nine months ended September 30, 2016, the correction of these errors was not material to any individual prior period, and did not have an effect on the trend of financial results, taking into account the requirements of the Securities and Exchange Commission (“SEC”) Staff Accounting Bulletin No. 99, Materiality and Staff Accounting Bulletin No. 108, Considering the Effects of Prior Year Misstatements when Quantifying Misstatements in Current Year Financial Statements . Because management has concluded that these errors are not material, we will correct them prospectively when the consolidated balance sheets, statements of operations, comprehensive loss and cash flows for such periods are included in future filings. |
Reclassifications | Reclassifications Certain prior period amounts in the Consolidated Financial Statements have been reclassified to conform to current period presentation. |
Segment Information | Segment Information We operate as a single reportable segment. |
Cash | Cash and Investments We consider all highly liquid investments purchased with an original maturity of three months or less to be cash equivalents. Cash equivalents include investments in high-grade, short-term money market funds, commercial paper and municipal securities, which are subject to minimal credit and market risk. |
Investments | We have designated all investments as available-for-sale and therefore, such investments are reported at fair value, with unrealized gains and losses recorded in accumulated other comprehensive loss. For securities sold prior to maturity, the cost of securities sold is based on the specific identification method. Realized gains and losses on the sale of investments are recorded in interest and other income, net. We classify those investments we do not require for use in current operations that mature in more than 12 months as Long-term investments on our Consolidated Balance Sheets. Additionally, those investments that collateralize loan balances with terms that extend 12 months or longer were classified as long-term investments even if the investment’s remaining term to maturity was one year or less; they are not restricted to withdrawal. All of our investments are subject to a quarterly impairment review. We recognize an impairment charge when a decline in the fair value of an investment below its cost basis is judged to be other-than-temporary. Factors considered in determining whether a loss is temporary include the length of time and extent to which the investments fair value has been less than their cost basis, the financial condition and near-term prospects of the issuer, extent of the loss related to credit of the issuer, the expected cash flows from the security, our intent to sell the security and whether or not we will be required to sell the security before we are able to recovery our carrying value. During the years ended December 31, 2016 , 2015 and 2014 , we did no t record any other-than-temporary impairment charges on our available-for-sale securities. |
Fair Value Measurements | Fair Value Measurements Fair value 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). We disclose the fair value of financial instruments for assets and liabilities for which the value is practicable to estimate. For those financial instruments measured and recorded at fair value on a recurring basis, we also provide fair value hierarchy information in these Notes to Consolidated Financial Statements. The fair value hierarchy has the following three levels: Level 1 – quoted prices (unadjusted) in active markets for identical assets and liabilities that the reporting entity can access at the measurement date. Level 2 – observable inputs, other than quoted prices in active markets for identical assets and liabilities that are observable either directly or indirectly. 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. |
Inventory | Inventory We value inventory 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 subject to expiry in excess of expected requirements, or that has a cost basis in excess of its expected net realizable value. The related costs are recognized as cost of goods sold in the Consolidated Statements of Operations. On a quarterly basis, we analyze our estimated production levels for the following twelve month period, which is our normal operating cycle and reclassify inventory we do not expect to use within the next twelve months into Other long-term assets in the Consolidated Balance Sheets. 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 are expensed as research and development costs. When regulatory approval is obtained, we begin capitalization of inventory related costs. |
Property and Equipment | Property and Equipment Property and equipment are recorded at cost and depreciated using the straight-line method over the following estimated useful lives: Equipment and furniture 5 years Computer equipment and software 3 years Leasehold improvements Shorter of lease life or 7 years Capitalized software includes certain internal use computer software costs. Repairs and maintenance costs are charged to expense as incurred. |
Goodwill | 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. Goodwill is not subject to amortization. We assess the recoverability of our goodwill annually, or more frequently whenever events or changes in circumstances indicate that the carrying amount of a reporting unit may exceed its fair value. The assessment of recoverability may first consider qualitative factors to determine whether the existence of events or circumstances leads to a determination that it is more likely than not that the fair value of a reporting unit is less than its carrying amount. A quantitative assessment is performed if the qualitative assessment results in a more-likely-than-not determination or if a qualitative assessment is not performed. The quantitative assessment considers whether the carrying amount of a reporting unit exceeds its fair value, in which case an impairment charge is recorded to the extent the carrying amount of the reporting unit’s goodwill exceeds its implied fair value. We continue to operate in one segment, which is also considered to be our sole reporting unit and therefore, goodwill was tested for impairment at the enterprise level as of December 31, 2016 and 2015 . |
Long-Lived Assets | Long-Lived Assets Long-lived assets include property and equipment. The carrying value of our long-lived assets is reviewed for impairment whenever events or changes in circumstances indicate that the asset may not be recoverable. An impairment loss would be recognized when estimated future cash flows expected to result from the use of the asset and its eventual disposition is less than its carrying amount. |
Revenue Recognition | Revenue Recognition We recognize revenue from product sales and from license fees, milestones and royalties earned on research and collaboration arrangements. 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 to specialty pharmacies and distributors in the U.S., this generally occurs upon delivery of the product. For product sales to our former distribution partner, Swedish Orphan Biovitrum (“Sobi”), this generally occurred when Sobi accepted the product. In the U.S., we sell our products, CABOMETYX and COMETRIQ, to specialty pharmacies and distributors that benefit from customer incentives and have a right of return under certain circumstances. Prior to 2015, COMETRIQ had limited sales history and we could not reliably estimate expected future returns, discounts and rebates of the product at the time the product was sold to a single specialty pharmacy, therefore we recognized revenue when the specialty pharmacy provided the product to a patient based on the fulfillment of a prescription. This is frequently referred to as the “sell-through” revenue recognition model. In January 2015, we established that we had sufficient historical experience and data to reasonably estimate expected future returns of COMETRIQ and the discounts and rebates due to payers at the time of shipment to the specialty pharmacy. Accordingly, beginning in January 2015 we began to recognize revenue upon delivery to the specialty pharmacy. This approach is frequently referred to as the “sell-in” revenue recognition model. In connection with the change in the timing of recognition of COMETRIQ sales in the U.S., we recorded a one-time adjustment to recognize revenue that had previously been deferred under the “sell-through” revenue recognition model, resulting in the additional recognition of gross product revenues of $2.6 million for the year ended December 31, 2015; there were no such additional amounts recorded during 2016 or 2014. In determining discounts and allowances for the initial launch and sale of CABOMETYX, in addition to using payer data received from the specialty pharmacies and distributors that sell CABOMETYX and historical data for COMETRIQ, we also utilized claims data from third party sources for competitor products for the treatment of advanced renal cell carcinoma (“RCC”). Based in part on the availability of this third party data, we made the determination that we had sufficient experience and data to reasonably estimate expected future returns and the discounts and allowances due to payers at the time of shipment to the specialty pharmacy or distributor, and therefore record revenue for the product using the “sell-in” revenue recognition model. Net product revenues during the year ended December 31, 2016 were impacted by the build of channel inventory related to the initial launch period for CABOMETYX. We also utilized the “sell-in” revenue recognition model for product sales to Sobi for all periods presented. As described further in “Note 2 - Collaboration Agreements”, under the terms of our collaboration and license agreement with Ipsen for the commercialization and further development of cabozantinib, we provided Sobi with a notice of termination of our commercialization agreement for COMETRIQ which became effective November 1, 2016. Product Sales Discounts and Allowances We calculate gross product revenues based on the price that we charge to the specialty pharmacies and distributors in the U.S. We estimate our domestic net product revenues by deducting from our gross product revenues (a) trade allowances, such as discounts for prompt payment, (b) estimated government rebates and chargebacks, (c) certain other fees paid to specialty pharmacies and distributors and (d) returns. Discounts and allowances for foreign sales for the years ended December 31, 2015 and 2014 included portions of a one-time $2.4 million project management fee payable to our European distribution partner upon its achievement of a cumulative revenue goal. During 2014, we determined that the achievement of the revenue goal was probable and therefore we recorded $2.3 million of the $2.4 million project management fee, of which $0.7 million would have been recorded in 2013 had the cumulative revenue goal been determined to be probable in that period. During 2015 we recorded an additional $0.1 million of the project management fee. 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. Customer Credits: The specialty pharmacies and distributors in the U.S. receive a discount of 2% for prompt payment. We expect the specialty pharmacies and distributors 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 third party market research data and customer and payer data received from the specialty pharmacies and distributors and historical utilization rates. Rebates are generally invoiced by the payer 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 our customers, 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 or distributor. Contracted customers, which currently consist primarily of Public Health Service institutions, non-profit clinics, Federal government entities purchasing via the Federal Supply Schedule and Group Purchasing Organizations, generally purchase the product at a discounted price. The specialty pharmacy or distributor, 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 an estimate of sales to contracted customers. Medicare Part D Coverage Gap: In the U.S., 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 payer data received from specialty pharmacies and distributors. 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 quarters’ 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 the specialty pharmacies and distributors. Collaboration Revenues We enter into collaboration agreements under which we may obtain upfront license fees, milestone, royalty and/or product supply payments. These arrangements have multiple elements and our deliverables may include intellectual property rights, distribution rights, delivery of manufactured product, commercial and development activities and participation on joint steering, commercial and development committees. In order to account for these arrangements, we identify the deliverables and evaluate whether the delivered elements have value to our collaboration partner on a stand-alone basis and represent separate units of accounting. Analyzing the arrangement to identify deliverables requires the use of judgment, and each deliverable may be an obligation to deliver future goods or services, a right or license to use an asset, or another performance obligation. If we determine that multiple deliverables exist, the consideration is allocated to one or more units of accounting based upon the best estimate of the selling price of each deliverable. The selling price used for each deliverable will be based on vendor-specific objective evidence, if available, third-party evidence if vendor-specific objective evidence is not available, or estimated selling price if neither vendor-specific or third-party evidence is available. A delivered item or items that do not qualify as a separate unit of accounting within the arrangement shall be combined with the other applicable undelivered items within the arrangement. The allocation of arrangement consideration and the recognition of revenue then shall be determined for those combined deliverables as a single unit of accounting. For a combined unit of accounting, non-refundable upfront fees are recognized in a manner consistent with the final deliverable, which has generally been ratably over the period of our continued involvement. Amounts received in advance of performance are recorded as deferred revenue. Upfront fees are classified as Collaboration revenues in our Consolidated Statements of Operations. Royalty revenues, and U.S. profits and losses under the collaboration agreement with Genentech, are based on amounts reported to us by our collaboration partners and are recorded when such information becomes available to us; for Ipsen, this occurs in the current quarter, and for Genentech, this occurs in the following quarter. We base our estimates on the best information available at the time provided to us by our collaboration partners. However, additional information may subsequently become available to us, which may allow us to make a more accurate estimate in future periods. In this event, we are required to record adjustments to collaboration revenue in future periods when the actual level of activity becomes more certain. Such increases or decreases in revenue are generally considered to be changes in estimates and will be reflected in collaboration revenues in the period they become known. We consider sales-based contingent payments to be royalty revenue which is generally recognized at the date the contingency is achieved. Royalty revenue is included in Collaboration revenues in our Consolidated Statements of Operations. For product supplied to Ipsen, which began during the year ended December 31, 2016, we record revenue at the time the product is delivered. Once title has transferred to Ipsen, the product is generally no longer subject to return. See “Note 2. Collaboration Agreements - Ipsen Collaboration” for a description of our product supply agreement with Ipsen. For certain milestone payments under collaboration agreements, we have made a policy election to recognize revenue using the milestone method. Under the milestone method a payment that is contingent upon the achievement of a substantive milestone is recognized in its entirety in the period in which the milestone is achieved. A milestone is an event: (i) that can be achieved based in whole or in part on either our performance or on the occurrence of a specific outcome resulting from our performance, (ii) for which there is substantive uncertainty at the date the arrangement is entered into that the event will be achieved and (iii) that would result in additional payments being due to us. The determination that a milestone is substantive requires estimation and judgment and is made at the inception of the arrangement. Milestones are considered substantive when the consideration earned from the achievement of the milestone is: (i) commensurate with either our performance to achieve the milestone or the enhancement of value of the item delivered as a result of a specific outcome resulting from our performance to achieve the milestone, (ii) relates solely to past performance and (iii) reasonable relative to all deliverables and payment terms in the arrangement. In making the determination as to whether a milestone is substantive or not, we consider all facts and circumstances relevant to the arrangement, including factors such as the scientific, regulatory, commercial and other risks that must be overcome to achieve the respective milestone, the level of effort and investment required to achieve the respective milestone and whether any portion of the milestone consideration is related to future performance or deliverables. Non-substantive milestone payments are recognized as revenues over the estimated period of our continued involvement. We may also receive milestone payments after the end of our continued involvement. In such circumstances, we would recognize 100% of the milestone revenues when the contingency is achieved. Milestones payments, when recognized as revenue, are classified as Collaboration revenues in our Consolidated Statements of Operations. Under the terms of our collaboration agreement with Genentech for cobimetinib, we are also entitled to a share of U.S. profits and losses received in connection with commercialization of cobimetinib. We are entitled to low double-digit royalties on ex-U.S. net sales. See “Note 2. Collaboration Agreements” for additional information about our collaboration agreement with Genentech. We have determined that we are an agent under the agreement and therefore revenues are recorded net of costs incurred. We record U.S. profits and losses under the collaboration agreement in the period earned based on our estimate of those amounts. As of December 31, 2016, we have not recognized a profit for any year to date period from the commercialization of cobimetinib in the U.S. Until we have recognized a profit under the agreement, losses are recognized as Selling, general and administrative expenses in our Consolidated Statements of Operations. In connection with our agreement to co-promote with Genentech, we are responsible for providing up to 25% of the sales force necessary to assist with the promotion of cobimetinib. Genentech reimburses us for these costs which we include as a reduction of our Selling, general and administrative costs when the obligations are incurred or we become entitled to the cost recovery. Patient Assistance Programs We provide CABOMETYX and COMETRIQ at no cost to eligible patients who have no insurance and meet certain financial and clinical criteria through our patient assistance programs. We record the cost of the product as a selling, general and administrative expense at the time the product is shipped to the specialty pharmacy for patient assistance use. |
Cost of Goods Sold | Cost of Goods Sold Cost of goods sold is related to our product revenues and consists primarily of a 3% royalty on net sales of any product incorporating cabozantinib payable to GlaxoSmithKline, indirect labor costs, the cost of manufacturing, write-downs related to expiring and excess inventory, and other third party logistics costs of our product. A portion of the manufacturing costs for product sales were incurred prior to regulatory approval of COMETRIQ and CABOMETYX and therefore, were expensed as research and development costs when those costs were incurred, rather than capitalized as inventory. In accordance with our product development and commercialization agreement with GlaxoSmithKline, we are required to pay GlaxoSmithKline a 3% royalty on the Net Sales of any product incorporating cabozantinib, including COMETRIQ and CABOMETYX. Net Sales is defined in the product development and commercialization agreement 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. |
Research and Development Expenses | Research and Development Expenses Research and development costs are expensed as incurred and include costs associated with research performed pursuant to collaborative agreements. Research and development costs consist of direct and indirect internal costs related to specific projects as well as fees paid to other entities that conduct certain research activities on our behalf. Substantial portions of our preclinical studies and all of our clinical trials have been executed with support from third-party contract research organizations (“CROs”) and other vendors. We accrue expenses for preclinical studies performed by our vendors based on certain estimates over the term of the service period and adjust our estimates as required. We accrue expenses for clinical trial activities performed by CROs based upon the estimated amount of work completed on each trial. For clinical trial expenses, the significant factors used in estimating accruals include the number of patients enrolled, the number of active clinical sites, and the duration for which the patients will be enrolled in the trial. We monitor patient enrollment levels and related activities to the extent possible through internal reviews, correspondence with CROs and review of contractual terms. We base our estimates on the best information available at the time. However, additional information may become available to us which may allow us to make a more accurate estimate in future periods. In this event, we may be required to record adjustments to research and development expenses in future periods when the actual level of activity becomes more certain. Such increases or decreases in costs will be reflected in research and development expenses in the period first known. |
Net Income (Loss) Per Share | Net Income (Loss) Per Share Basic net income (loss) per share is computed by dividing the net income (loss) allocated to common shares for the period by the weighted average number of shares of common stock outstanding during the period. Diluted net income (loss) per share gives effect to potential incremental common shares issuable upon the exercise of stock options and warrants, and shares issuable pursuant to restricted stock units (“RSUs”) (calculated based on the treasury stock method), and upon conversion of our convertible debt (calculated using an as-if-converted method) as long as such shares are not anti-dilutive. |
Foreign Currency Translation and Remeasurement | Foreign Currency Translation and Remeasurement Monetary assets and liabilities denominated in currencies other than the functional currency are remeasured using exchange rates in effect at the end of the period and related gains or losses are recorded in interest income and other, net. Gains and losses on the remeasurement of monetary assets and liabilities were not material for any of the years presented. We do not have any nonmonetary assets or liabilities denominated in currencies other than the U.S. dollar. |
Stock-Based Compensation | Stock-Based Compensation Stock-based compensation expense is based on the grant date fair value; the grant date fair value of RSUs is estimated as the value of the underlying shares of our common stock and the grant date fair value of stock-options is estimated using the Black-Scholes Merton option pricing model. Because there is a market for options on our common stock, we have considered implied volatilities as well as our historical realized volatilities when developing an estimate of expected volatility. We estimate the term using historical data. We recognize compensation expense on a straight-line basis over the requisite service period. Compensation expense relating to awards subject to performance conditions is recognized if it is probable that the performance goals will be achieved on a straight-line basis through the anticipated achievement date of the performance objectives. The probability of achievement is assessed on a quarterly basis. The total number of awards expected to vest is adjusted for estimated forfeitures. We have elected to use the simplified method to calculate the beginning pool of excess tax benefits. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2014-09, Revenue from Contracts with Customers (Topic 606) , (“ASU 2014-09”). In August 2015, the FASB issued ASU No. 2015-14, Revenue from Contracts with Customers (Topic 606): Deferral of the Effective Date , which delays the effective date of ASU 2014-09 by one year. ASU 2014-09, as amended, becomes effective for us in the first quarter of fiscal year 2018, but allows us to adopt the standard one year earlier. We currently plan to adopt ASU 2014-09 in the first quarter of fiscal year 2018. ASU 2014-09 also permits two methods of adoption: retrospectively to each prior reporting period presented (full retrospective method), or retrospectively with the cumulative effect of initially applying the guidance recognized at the date of initial application (the modified retrospective method). We currently anticipate adopting ASU 2014-09 using the modified retrospective method. The core principle of ASU 2014-09 is that an entity should recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. ASU 2014-09 defines a five step process to achieve this core principle and, in doing so, it is possible more judgment and estimates may be required within the revenue recognition process than required under existing U.S. generally accepted accounting pronouncements. We do not expect that ASU 2014-09 will have a material impact on the recognition of revenue from product sales. We are still in the process of evaluating the effect that this guidance will have on revenue recognition from our collaboration agreements such as our arrangements with Ipsen and Genentech. We expect our evaluation to be completed by the end of the second quarter of 2017. In April 2015, the FASB issued ASU No. 2015-05, Intangibles—Goodwill and Other—Internal-Use Software (Subtopic 350-40): Customer’s Accounting for Fees Paid in a Cloud Computing Arrangement, (“ASU 2015-05”) . ASU 2015-05 provides guidance to customers about whether a cloud computing arrangement includes a software license. If a cloud computing arrangement includes a software license, then the customer should account for the software license element of the arrangement consistent with the acquisition of other software licenses. If a cloud computing arrangement does not include a software license, the customer should account for the arrangement as a service contract. ASU 2015-05 was effective for all interim and annual reporting periods beginning after December 15, 2015 and therefore we adopted ASU 2015-05 in 2016 on a prospective basis. The adoption of ASU 2015-05 did not have a material impact on our Consolidated Financial Statements during the period of adoption and is not expected to have a material effect on our Consolidated Financial Statements in future periods. In July 2015, the FASB issued ASU No. 2015-11, Inventory: Simplifying the Measurement of Inventory, (“ ASU No. 2015-11”) . ASU No. 2015-11 requires inventory measurement at the lower of cost and net realizable value. ASU No. 2015-11 is effective for fiscal years beginning after December 15, 2016, including interim periods within those fiscal years. Early adoption is permitted by all entities as of the beginning of an interim or annual reporting period. We are in the process of assessing the impact, if any, of ASU No. 2015-11 on our Consolidated Financial Statements. In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842), (“ASU 2016-02”) . Under ASU 2016-02, a lessee will be required to recognize assets and liabilities for leases with lease terms of more than 12 months. Recognition, measurement, and presentation of expenses and cash flows arising from a lease by a lessee primarily will depend on its classification as a finance or operating lease. ASU 2016-02 will require both types of leases to be recognized on the balance sheet. The ASU also will require disclosures to help investors and other financial statement users better understand the amount, timing, and uncertainty of cash flows arising from leases. These disclosures include qualitative and quantitative requirements, providing additional information about the amounts recorded in the financial statements. ASU 2016-02 is effective for us for all interim and annual reporting periods beginning after December 15, 2018. Early adoption is permitted. We are in the process of assessing the impact of ASU No. 2016-02 on our Consolidated Financial Statements. In March 2016, the FASB issued ASU No. 2016-09, Compensation—Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting, (“ASU 2016-09”) . ASU 2016-09 is aimed at the simplification of several aspects of the accounting for employee share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities, and classification on the statement of cash flows. ASU 2016-09 is effective for all interim and annual reporting periods beginning after December 15, 2016. Early adoption is permitted. We do not expect the adoption of ASU 2016-09 to have a material impact on our Consolidated Financial Statements. In August 2016, the FASB issued ASU No. 2016-15, Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments (a consensus of the FASB Emerging Issues Task Force), (“ASU 2016-15”) . ASU 2016-15 addresses eight specific cash flow issues including debt prepayment or debt extinguishment costs, settlement of zero-coupon debt instruments or other debt instruments with coupon interest rates that are insignificant in relation to the effective interest rate of the borrowing and contingent consideration payments made after a business combination. ASU 2016-15 is effective for all interim and annual reporting periods beginning after December 15, 2017. Early adoption is permitted. We do not expect the adoption of ASU 2016-15 to have a material impact on our Consolidated Statements of Cash Flows. In November 2016, the FASB issued ASU No. 2016-18, Statement of Cash Flows (Topic 230): Restricted Cash (a consensus of the FASB Emerging Issues Task Force), (“ASU 2016-18”) . ASU 2016-18 requires that a statement of cash flows explain the change during the period in the total of cash, cash equivalents, and amounts generally described as restricted cash or restricted cash equivalents. Therefore, amounts generally described as restricted cash and restricted cash equivalents should be included with cash and cash equivalents when reconciling the beginning-of-period and end-of-period total amounts shown on the statement of cash flows. ASU 2016-18 is effective for all interim and annual reporting periods beginning after December 15, 2017. Early adoption is permitted. We do not expect the adoption of ASU 2016-18 to have a material impact on our Consolidated Statements of Cash Flows. In January 2017, the FASB issued ASU No. 2017-04, Intangibles—Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment, (“ASU 2017-04”) . ASU 2017-04 eliminated Step 2 from the goodwill impairment test. Instead, under the amendments in ASU 2017-04, an entity should perform its annual, or interim, goodwill impairment test by comparing the fair value of a reporting unit with its carrying amount. An entity should recognize an impairment charge for the amount by which the carrying amount exceeds the reporting unit’s fair value; however, the loss recognized should not exceed the total amount of goodwill allocated to that reporting unit. Additionally, an entity should consider income tax effects from any tax deductible goodwill on the carrying amount of the reporting unit when measuring the goodwill impairment loss, if applicable. ASU 2017-04 is effective for all interim and annual reporting periods beginning after December 15, 2019. Early adoption is permitted. We do not expect the adoption of ASU 2017-04 to have a material impact on our Consolidated Financial Statements. |
Organization and Summary of S26
Organization and Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Estimated Useful Lives of Property and Equipment | Property and equipment are recorded at cost and depreciated using the straight-line method over the following estimated useful lives: Equipment and furniture 5 years Computer equipment and software 3 years Leasehold improvements Shorter of lease life or 7 years |
Schedule of Error Corrections | Following are the amounts (in thousands, except per share amounts) that should have been reported for the affected line items of the statements of operations, statements of comprehensive loss and statements of cash flows: Year ended December 31, 2015 2014 2013 2012 Statements of Operations: Interest expense, overstated by $7,993, $7,245, $6,568, $2,310 for the years ended December 31, 2015, 2014, 2013 and 2012, respectively $ (40,680 ) $ (41,362 ) $ (38,779 ) $ (24,778 ) Total other expense, net, overstated by $7,993, $7,245, $6,568, $2,310 for the years ended December 31, 2015, 2014, 2013 and 2012, respectively $ (40,268 ) $ (37,021 ) $ (37,556 ) $ (22,792 ) Net loss, overstated by $7,993, $7,245, $6,568, $2,310 for the years ended December 31, 2015, 2014, 2013 and 2012, respectively $ (161,744 ) $ (261,297 ) $ (238,192 ) $ (145,335 ) Net loss per share, basic and diluted, overstated by $0.04, $0.04, $0.04, $0.01 for the years ended December 31, 2015, 2014, 2013 and 2012, respectively $ (0.77 ) $ (1.34 ) $ (1.29 ) $ (0.91 ) Statements of Comprehensive Loss: Comprehensive loss, overstated by $7,993, $7,245, $6,568, $2,310 for the years ended December 31, 2015, 2014, 2013 and 2012, respectively $ (161,855 ) $ (261,564 ) $ (237,954 ) $ (145,289 ) Statements of Cash Flows (1) : Net loss, overstated by $7,993, $7,245, $6,568, $2,310 for the years ended December 31, 2015, 2014, 2013 and 2012, respectively $ (161,744 ) $ (261,297 ) $ (238,192 ) $ (145,335 ) Accretion of debt discount and debt issuance costs, overstated by $7,993, $7,245, $6,568, $2,310 for the years ended December 31, 2015, 2014, 2013 and 2012, respectively $ 17,041 $ 22,289 $ 19,722 $ 12,442 ____________________ (1) The error did not impact our net cash provided by or used in operating activities, financing activities or investing activities for any of the periods presented. Following are the amounts (in thousands) that should have been reported for the affected line items of the balance sheets and statements of stockholders’ (deficit) equity: December 31, 2015 2014 2013 2012 Balance Sheets: Long-term portion of convertible notes, understated by $36,502, $44,494, $51,739, $58,307 as of December 31, 2015, 2014, 2013 and 2012, respectively $ 337,937 $ 223,629 $ 301,550 $ 291,828 Liabilities, understated by $36,502, $44,494, $51,739, $58,307 as of December 31, 2015, 2014, 2013 and 2012, respectively $ 473,148 $ 482,592 $ 483,452 $ 476,015 Additional paid-in capital, overstated by $60,618 as of all dates presented $ 1,772,123 $ 1,591,782 $ 1,504,052 $ 1,489,727 Accumulated deficit, overstated by $24,116, $16,124, $8,879, $2,310 as of December 31, 2015, 2014, 2013 and 2012, respectively $ (1,912,925 ) $ (1,751,181 ) $ (1,489,884 ) $ (1,251,692 ) Stockholders’ equity (deficit), misstated by $36,502, $44,494, $51,739, $58,307 as of December 31, 2015, 2014, 2013 and 2012, respectively $ (140,806 ) $ (159,324 ) $ 14,498 $ 238,127 Statements of Stockholders’ Equity (Deficit): Net loss, overstated by $7,993, $7,245, $6,568, $2,310 for the years ended December 31, 2015, 2014, 2013 and 2012, respectively $ (161,744 ) $ (261,297 ) $ (238,192 ) $ (145,335 ) Additional paid-in capital, overstated by $60,618 as of all dates presented $ 1,772,123 $ 1,591,782 $ 1,504,052 $ 1,489,727 Accumulated deficit, overstated by $24,116, $16,124, $8,879, $2,310 as of December 31, 2015, 2014, 2013 and 2012, respectively $ (1,912,925 ) $ (1,751,181 ) $ (1,489,884 ) $ (1,251,692 ) Stockholders’ equity (deficit), misstated by $36,502, $44,494, $51,739, $58,307 as of December 31, 2015, 2014, 2013 and 2012, respectively $ (140,806 ) $ (159,324 ) $ 14,498 $ 238,127 |
Collaboration Agreements (Table
Collaboration Agreements (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedule of Collaborative Revenues Under Collaboration Agreement | During the year ended December 31, 2016 , collaboration revenues under the collaboration agreement were as follows (in thousands): Year Ended December 31, 2016 Milestones achieved $ 20,000 Amortization of upfront payments and deferred milestone 13,284 Royalty revenue 175 Product supply agreement revenue 1,612 Cost of supplied product (1,555 ) Royalty payable to GlaxoSmithKline on net sales by Ipsen (264 ) Collaboration revenues under the collaboration agreement $ 33,252 During the years ended December 31, 2016 , 2015 and 2014, collaboration revenues and (loss) net cost recovery under the collaboration agreement were as follows (in thousands): Year Ended December 31, 2016 2015 2014 Collaboration revenues: Royalty revenues on ex-U.S. sales of COTELLIC $ 2,827 $ 14 $ — (Loss) net cost recovery under the collaboration agreement included in Selling, general and administrative expenses $ 8,771 $ (16,600 ) $ (2,916 ) |
Restructurings (Tables)
Restructurings (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Restructuring Charges [Abstract] | |
Schedule of Outstanding Restructuring Liability | The changes of these liabilities and the cumulative restructuring charge from inception to date are summarized in the following table (in thousands): 2010 Restructurings 2014 Restructuring Facility Other Employee Severance and Other Benefits Facility Other Total Restructuring liability as of December 31, 2013 $ 13,460 $ 12 $ — $ — $ — $ 13,472 Restructuring charge (recovery) 1,626 (117 ) 5,775 65 247 7,596 Proceeds from sale of assets — 199 — — 100 299 Other cash payments, net (5,644 ) (8 ) (4,507 ) (65 ) (12 ) (10,236 ) Other items 12 (86 ) 22 — (288 ) (340 ) Restructuring liability as of December 31, 2014 9,454 — 1,290 — 47 10,791 Restructuring charge (recovery) 757 — (269 ) 1,582 (1,028 ) 1,042 Proceeds from sale of assets — — — — 1,325 1,325 Other cash payments, net (6,449 ) — (1,021 ) (1,357 ) — (8,827 ) Other items 325 — — 278 (344 ) 259 Restructuring liability as of December 31, 2015 4,087 — — 503 — 4,590 Restructuring charge 902 — — 12 — 914 Other cash payments, net (4,039 ) — — (500 ) (34 ) (4,573 ) Other items 975 — — — 34 1,009 Restructuring liability as of December 31, 2016 $ 1,925 $ — $ — $ 15 $ — $ 1,940 Restructuring charge (recovery) from implementation to date $ 32,517 $ 23,933 (1) $ 5,506 $ 1,659 $ (781 ) (1) $ 62,834 ____________________ (1) Other restructuring charge from implementation to date for the 2010 Restructurings includes $21.7 million in charges related to employee severance and other benefits for periods ended prior to December 31, 2013. The remainder of Other activity for both restructurings relates primarily to the impairment and sale of property and equipment. |
Cash and Investments (Tables)
Cash and Investments (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of Available-for-Sale Securities | The following tables summarize cash and cash equivalents, investments, and restricted cash and investments by balance sheet line item as of December 31, 2016 and 2015 (in thousands): December 31, 2016 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Cash and cash equivalents $ 151,686 $ — $ — $ 151,686 Short-term investments 268,234 13 (130 ) 268,117 Long-term investments 55,792 1 (192 ) 55,601 Long-term restricted investments 4,150 — — 4,150 Total cash and investments $ 479,862 $ 14 $ (322 ) $ 479,554 December 31, 2015 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Cash and cash equivalents $ 141,634 $ — $ — $ 141,634 Short-term investments 25,484 5 (63 ) 25,426 Long-term investments 83,665 2 (67 ) 83,600 Long-term restricted investments 2,650 — — 2,650 Total cash and investments $ 253,433 $ 7 $ (130 ) $ 253,310 |
Summary of Cash Equivalents and Investments by Security Type | The amounts presented exclude cash, but include investments classified as cash equivalents (in thousands): December 31, 2016 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Money market funds $ 71,457 $ — $ — $ 71,457 Commercial paper 165,375 — — 165,375 Corporate bonds 152,712 3 (308 ) 152,407 U.S. Treasury and government sponsored enterprises 70,730 11 (14 ) 70,727 Total investments $ 460,274 $ 14 $ (322 ) $ 459,966 December 31, 2015 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Money market funds $ 72,000 $ — $ — $ 72,000 Commercial paper 78,155 — — 78,155 Corporate bonds 72,205 4 (118 ) 72,091 U.S. Treasury and government sponsored enterprises 28,434 1 (12 ) 28,423 Marketable equity securities 16 2 — 18 Total investments $ 250,810 $ 7 $ (130 ) $ 250,687 |
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 December 31, 2016 (in thousands): Mature within One Year After One Year through Two Years Fair Value Money market funds $ 71,457 $ — $ 71,457 Commercial paper 165,375 — 165,375 Corporate bonds 99,455 52,952 152,407 U.S. Treasury and government sponsored enterprises 68,078 2,649 70,727 Total $ 404,365 $ 55,601 $ 459,966 |
Inventory (Tables)
Inventory (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory | Inventory consists of the following (in thousands): December 31, 2016 2015 Raw materials $ 863 $ 1,037 Work in process 2,343 2,251 Finished goods 738 583 Total 3,944 3,871 Less: non-current portion included in Other long-term assets (606 ) (1,255 ) Inventory $ 3,338 $ 2,616 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment | Property and equipment consisted of the following (in thousands): December 31, 2016 2015 Laboratory equipment $ 4,310 $ 4,749 Computer equipment and software 13,738 11,890 Furniture and fixtures 2,240 2,253 Leasehold improvements 6,646 6,395 Construction-in-progress 19 456 26,953 25,743 Less: accumulated depreciation and amortization (24,882 ) (24,309 ) Property and equipment, net $ 2,071 $ 1,434 |
Debt (Tables)
Debt (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Debt Disclosure [Abstract] | |
Schedule of Debt | The amortized carrying amount of our debt consists of the following (in thousands): December 31, 2016 2015 Secured Convertible Notes due 2018 (“Deerfield Notes”) $ 109,122 $ 102,727 Term loan payable 80,000 80,000 2019 Notes — 235,210 Total debt 189,122 417,937 Less: current portion (189,122 ) — Long-term debt $ — $ 417,937 |
Summary of Interest Expense on Notes | The following is a summary of interest expense for the Deerfield Notes (in thousands): Year Ended December 31, 2016 2015 2014 Stated coupon interest $ 8,008 $ 6,792 $ 6,000 Interest paid in kind 8,008 3,817 — Amortization of debt discount and debt issuance costs 457 5,461 11,731 Total interest expense $ 16,473 $ 16,070 $ 17,731 The following is a summary of the interest expense for the 2019 Notes (in thousands): Year Ended December 31, 2016 2015 2014 Stated coupon interest $ 7,799 $ 12,218 $ 12,253 Amortization of debt discount and debt issuance costs 7,975 11,581 10,525 Total interest expense $ 15,774 $ 23,799 $ 22,778 |
Summary of Loss on Extinguishment of Debt | The following is a summary of loss on extinguishment of debt for the conversion and redemption of the 2019 Notes for the year ended December 31, 2016 (in thousands): Inducements included in August 9, 2016 and August 19, 2016 agreements: Cash inducements $ 2,394 Repayments of interest required upon a conversion under the terms of the indenture that were not repaid under the terms of the exchange agreements 3,572 Difference between the total settlement consideration attributed to the liability component of the 2019 Notes and the net carrying value of the liability, described above 7,338 Unamortized discount on redeemed notes 83 Third party costs 514 Loss on extinguishment of debt $ 13,901 |
Schedule of Future Principal Payments of Total Long-term Debt | Aggregate contractual future principal payments of our debt are as follows as of December 31, 2016 (in thousands): Year Ending December 31, (1) 2017 $ 80,000 2018 124,972 Thereafter — ____________________ (1) As described above, we intend to repay the Deerfield Notes, which have a contractual maturity of July 1, 2018, on or about July 1, 2017. The actual timing of payments may differ materially. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Fair Value Disclosures [Abstract] | |
Schedule of Fair Value of Financial Assets Measured on a Recurring Basis | The amounts presented exclude cash, but include investments classified as cash equivalents (in thousands): December 31, 2016 Level 1 Level 2 Total Money market funds $ 71,457 $ — $ 71,457 Commercial paper — 165,375 165,375 Corporate bonds — 152,407 152,407 U.S. Treasury and government sponsored enterprises — 70,727 70,727 Total financial assets $ 71,457 $ 388,509 $ 459,966 December 31, 2015 Level 1 Level 2 Total Money market funds $ 72,000 $ — $ 72,000 Commercial paper — 78,155 78,155 Corporate bonds — 72,091 72,091 U.S. Treasury and government sponsored enterprises — 28,423 28,423 Marketable equity securities 18 — 18 Total financial assets $ 72,018 $ 178,669 $ 250,687 |
Reconciliation of Changes in Fair Value of Warrants Classified as Level 3 | The following is a reconciliation of changes in the fair value of warrants which are classified as Level 3 in the fair value hierarchy (in thousands) : Balance at December 31, 2014 $ 921 Unrealized loss at final re-measurement of warrants on March 18, 2015, included in Interest income and other, net 549 Transfer of warrants from Other long-term liabilities to Additional paid-in capital at their estimated fair value upon warrant repricing on March 18, 2015 (1,470 ) Balance at December 31, 2015 $ — |
Schedule of Estimated Fair Value of Financial Instruments | The estimated fair value of our financial instruments that are carried at amortized cost is as follows (in thousands) : December 31, 2016 December 31, 2015 Carrying Amount Fair Value Carrying Amount Fair Value Deerfield Notes $ 109,122 $ 121,220 $ 102,727 $ 101,096 Term loan payable $ 80,000 $ 79,784 $ 80,000 $ 79,815 2019 Notes $ — $ — $ 235,210 $ 336,260 |
Employee Equity and Benefit P34
Employee Equity and Benefit Plans (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Schedule of Allocated Employee Stock-Based Compensation Expense | We recorded and allocated employee stock-based compensation expense for our equity incentive plans and our ESPP as follows (in thousands): Year Ended December 31, 2016 2015 2014 Research and development expense $ 9,366 $ 11,691 $ 3,245 Selling, general and administrative expense 13,546 10,286 6,783 Restructuring related recovery — — (22 ) Total employee stock-based compensation expense $ 22,912 $ 21,977 $ 10,006 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value | The weighted average grant-date fair value of our stock options and ESPP purchases was as follows: 2016 2015 2014 Stock options $ 4.77 $ 2.55 $ 1.46 ESPP $ 2.17 $ 1.20 $ 1.28 |
Schedule of Fair Value of Employee Share-Based Payments Awards Stock Option Assumptions and Weighted Average Fair Values | The fair value of employee stock option awards and ESPP purchases was estimated using the following assumptions: Stock Options 2016 2015 2014 Risk-free interest rate 1.15 % 1.22 % 1.80 % Dividend yield — % — % — % Volatility 76 % 93 % 85 % Expected life 4.4 years 4.5 years 5.5 years |
Schedule of Fair Value of Employee Share-Based Payments Awards ESPP Assumptions and Weighted Average Fair Values | ESPP 2016 2015 2014 Risk-free interest rate 0.55 % 0.15 % 0.06 % Dividend yield — % — % — % Volatility 65 % 98 % 69 % Expected life 6 months 6 months 6 months |
Summary of All Stock Option Activity | A summary of all stock option activity for the year ended December 31, 2016 is presented below (dollars in thousands , except per share amounts): Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term Aggregate Intrinsic Value Options outstanding at December 31, 2015 27,425,854 $ 4.22 Granted 4,200,950 $ 8.29 Exercised (6,239,022 ) $ 4.07 Forfeited (307,601 ) $ 4.67 Expired (80,516 ) $ 10.49 Options outstanding at December 31, 2016 24,999,665 $ 4.91 4.54 years $ 250,996 Exercisable at December 31, 2016 17,731,361 $ 4.01 3.98 years $ 193,288 |
Summary of Information About Stock Options Outstanding | The following table summarizes information about stock options outstanding and exercisable at December 31, 2016 : Options Outstanding Options Outstanding and Exercisable Exercise Price Range Number Weighted Average Remaining Contractual Life Weighted Average Exercise Price Number Exercisable Weighted Average Exercise Price $1.46 - $1.90 8,231,617 4.64 years $ 1.77 8,088,721 $ 1.77 $2.57 - $4.05 2,707,474 5.57 years $ 3.56 1,130,251 $ 3.27 $4.16 - $5.55 5,957,725 3.58 years 3,186,063 $ 5.18 4,520,554 $ 5.31 $5.61 - $6.21 4,076,881 6,881 5.17 years $ 6.08 1,861,457 $ 6.00 $6.25 - $18.25 4,025,968 4.42 years $ 10.67 2,130,378 $ 8.42 24,999,665 4.54 years $ 4.91 17,731,361 $ 4.01 |
Summary of All RSU Activity | A summary of all RSU activity was as follows for all periods presented (dollars in thousands, except per share amounts): Shares Weighted Average Grant Date Fair Value Weighted Average Remaining Contractual Term Aggregate Intrinsic Value Awards outstanding at December 31, 2015 1,002,188 $ 5.16 Awarded 3,138,236 $ 7.58 Vested and released (1,640,324 ) $ 4.49 Forfeited (30,309 ) $ 4.77 Awards outstanding at December 31, 2016 2,469,791 $ 8.69 1.93 years $ 36,825 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Income Tax Disclosure [Abstract] | |
Schedule of Consolidated Net Income (Loss) | The income tax (benefit) provision is based on the following loss before income taxes (in thousands): Year Ended December 31, 2016 2015 2014 Domestic $ (70,222 ) $ (150,846 ) $ (230,535 ) Foreign — (10,843 ) (30,944 ) Total $ (70,222 ) $ (161,689 ) $ (261,479 ) |
Schedule of Components of Income Tax Expense (Benefit) | Income tax expense (benefit) consists of the following for the periods shown below (in thousands): Year Ended December 31, 2016 2015 2014 Current: Federal $ — $ — $ — State — 55 (182 ) Total current tax expense — 55 (182 ) Deferred: Federal — — — State — — — Total deferred tax expense — — — Income tax provision (benefit) $ — $ 55 $ (182 ) |
Schedule of Reconciliation of Income Taxes At The Statutory Federal Income Tax Rate to Net Income Taxes | A reconciliation of income taxes at the statutory federal income tax rate to our income tax (benefit) provision included in the Consolidated Statements of Operations is as follows (in thousands): Year Ended December 31, 2016 2015 2014 U.S. federal income tax benefit at statutory rate $ (23,876 ) $ (54,974 ) $ (88,903 ) Unutilized net operating losses 6,377 51,421 84,985 State tax expense 6,520 55 (182 ) Debt extinguishment 4,726 — — Non-deductible interest 2,680 3,308 3,598 Stock-based compensation 3,155 195 255 Other 418 50 65 Income tax (benefit) provision $ — $ 55 $ (182 ) |
Schedule of Deferred Assets and Liabilities | Our deferred tax assets and liabilities consist of the following (in thousands): December 31, 2016 2015 Deferred tax assets: Net operating loss carry-forwards $ 471,327 $ 464,504 Book over tax depreciation and amortization 70,617 1,752 Tax credit and charitable contribution carry-forwards 64,367 64,350 Amortization of deferred stock compensation – non-qualified 14,780 14,615 Accruals and reserves not currently deductible 8,117 7,775 Other 106 — Total deferred tax assets 629,314 552,996 Valuation allowance (629,062 ) (536,327 ) Net deferred tax assets 252 16,669 Deferred tax liabilities: Unrealized gain on derivatives (252 ) (497 ) Convertible debt — (16,172 ) Total deferred tax liabilities (252 ) (16,669 ) Net deferred taxes $ — $ — |
Schedule of Unrecognized Tax Benefits | The following table summarizes the activity related to our unrecognized tax benefits (in thousands): Year Ended December 31, 2016 2015 2014 Beginning balance $ 88,638 $ 58,215 $ 55,077 Decrease (increase) relating to prior year provision (29,110 ) 21,696 719 Increase relating to current year provision 2,304 8,727 2,706 Reductions based on the lapse of the applicable statutes of limitations (23 ) — (287 ) Ending balance $ 61,809 $ 88,638 $ 58,215 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Earnings Per Share [Abstract] | |
Schedule of Reconciliation of Basic and Diluted 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): Year Ended December 31, 2016 2015 2014 Numerator: Net loss $ (70,222 ) $ (161,744 ) $ (261,297 ) Denominator: Shares used in computing basic and diluted net loss per share 250,531 209,227 194,299 Net loss per share, basic and diluted $ (0.28 ) $ (0.77 ) $ (1.34 ) |
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 outstanding as of the dates presented that are not included in the computation of diluted net loss per share because to do so would be anti-dilutive (in thousands): December 31, 2016 2015 2014 Convertible debt 33,890 88,008 75,734 Outstanding stock options, unvested RSUs and ESPP contributions 27,568 28,470 28,930 Warrants 1,000 1,000 1,000 Total potentially dilutive shares 62,458 117,478 105,664 |
Commitments (Tables)
Commitments (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Aggregate Future Minimum Lease Payments Under Operating Leases | Aggregate future minimum lease payments under our operating leases are as follows (in thousands): Year Ending December 31, Operating Leases (1) 2017 8,474 2018 3,007 $ 11,481 ____________________ (1) Minimum payments have not been reduced by minimum sublease rentals of $1.2 million due in the future under noncancelable subleases. The following is a summary of aggregate future minimum lease payments under operating leases at December 31, 2016 , by operating lease agreements (in thousands): Original Term (Expiration) Renewal Options Future Minimum Lease Payments Building Lease #1 and 2 May 2017 none $ 3,425 Building Lease #3 July 2018 1 additional period of 5 years 8,056 Total $ 11,481 |
Concentrations of Credit Risk (
Concentrations of Credit Risk (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Risks and Uncertainties [Abstract] | |
Schedules of Concentration Risk | The following table shows the revenues earned by geographic region. Net product revenues are attributed to regions based on ship-to location. Collaboration revenues are attributed to regions based on the location of the collaboration partner (dollars in thousands): Year Ended December 31, 2016 2015 2014 U.S. $ 140,709 $ 33,869 $ 24,832 Europe 35,745 3,303 279 Rest of world 15,000 — — The following table sets forth the percentage of revenues recognized by customer that represent 10% or more of total revenues: Year Ended December 31, 2016 2015 2014 Diplomat Specialty Pharmacy 33 % 83 % 99 % Ipsen 17 % — % — % |
Quarterly Financial Data (Una39
Quarterly Financial Data (Unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Quarterly Financial Information Disclosure [Abstract] | |
Schedule of Quarterly Financial Data | The following tables summarize the unaudited quarterly financial data for the last two fiscal years (in thousands, except per share data): Quarter Ended December 31, September 30, June 30, March 31, 2016: Revenues $ 77,581 $ 62,194 $ 36,252 $ 15,427 Gross profit $ 50,064 $ 40,287 $ 30,058 $ 8,414 Income (loss) from operations $ 38,883 $ 7,264 $ (25,136 ) $ (49,135 ) Net income (loss) $ 35,123 $ (11,284 ) $ (34,838 ) $ (59,223 ) Net income (loss) per share, basic and diluted $ 0.12 $ (0.04 ) $ (0.15 ) $ (0.26 ) 2015: Revenues $ 9,938 $ 9,854 $ 7,992 $ 9,388 Gross profit $ 8,915 $ 8,434 $ 7,306 $ 8,622 Loss from operations $ (31,600 ) $ (35,781 ) $ (31,280 ) $ (22,760 ) Net loss (1) $ (41,568 ) $ (45,542 ) $ (41,389 ) $ (33,245 ) Net loss per share, basic and diluted (1) $ (0.18 ) $ (0.21 ) $ (0.21 ) $ (0.17 ) ____________________ (1) Prior period balances reflect revisions due to a correction of an immaterial error with regards to the 2019 Notes. The immaterial error resulted in an overstatement of the discount on the 2019 Notes and therefore overstated the related interest expense. Therefore, net loss was overstated by $2.2 million , $2.1 million , $2.1 million , $2.0 million , $2.0 million , $1.9 million for the quarters ended June 30 2016 and March 31, 2016, December 31, 2015, September 30, 2015, June 30 2015 and March 31, 2015, respectively, and net loss per share, basic and diluted was overstated by $0.01 , for each of those quarters. See “Note 1. Organization and Summary of Significant Accounting Policies - Correction of an Immaterial Error” for additional information on the correction of the immaterial error. |
Organization and Summary of S40
Organization and Summary of Significant Accounting Policies (Narrative) (Details) | 1 Months Ended | 12 Months Ended | ||
Nov. 30, 2015 | Dec. 31, 2016USD ($)segmentproduct | Dec. 31, 2015USD ($) | Dec. 31, 2014USD ($) | |
Organization And Summary Of Significant Policies [Line Items] | ||||
Number of products that entered in the commercial marketplace | product | 3 | |||
Number of reportable segments | segment | 1,000 | |||
Other-than-temporary impairment charges on available-for-sale securities | $ 0 | $ 0 | $ 0 | |
Impairment charge on goodwill | 0 | 0 | 0 | |
Net product revenues | $ 135,375,000 | 34,158,000 | 25,111,000 | |
Percent discount for prompt payment | 2.00% | |||
Discount expected to be earned (as a percent) | 100.00% | |||
Percentage of revenues recognized upon achievement of contingency | 100.00% | |||
Sobi [Member] | ||||
Organization And Summary Of Significant Policies [Line Items] | ||||
Reduction to net product revenues | 100,000 | 2,300,000 | ||
Amount of reduction relating to prior periods | 700,000 | |||
Sobi [Member] | Sales Discount, Returns and Allowances [Member] | ||||
Organization And Summary Of Significant Policies [Line Items] | ||||
One-time project management fee | 2,400,000 | |||
GlaxoSmithKline [Member] | ||||
Organization And Summary Of Significant Policies [Line Items] | ||||
Percent of royalty on net sale | 3.00% | |||
Collaborative Arrangement with Genentech [Member] | ||||
Organization And Summary Of Significant Policies [Line Items] | ||||
Percentage of share of the Company in promotions | 25.00% | |||
Collaborative Arrangement with Genentech [Member] | Maximum [Member] | ||||
Organization And Summary Of Significant Policies [Line Items] | ||||
Percentage of share of the Company in promotions | 25.00% | |||
“Sell-In” Revenue Recognition Model [Member] | ||||
Organization And Summary Of Significant Policies [Line Items] | ||||
Net product revenues | $ 0 | 2,600,000 | $ 0 | |
Restatement Adjustment [Member] | Other Current Liabilities [Member] | ||||
Organization And Summary Of Significant Policies [Line Items] | ||||
Current portion of restructuring, reclassified | 3,200,000 | |||
Restatement Adjustment [Member] | Other Noncurrent Liabilities [Member] | ||||
Organization And Summary Of Significant Policies [Line Items] | ||||
Long-term portion of restructuring, reclassified | $ 1,400,000 | |||
Products Derived from Cabozantinib [Member] | ||||
Organization And Summary Of Significant Policies [Line Items] | ||||
Number of products that entered in the commercial marketplace | product | 2 |
Organization and Summary of S41
Organization and Summary of Significant Accounting Policies (Error Correction) (Details) - USD ($) | 3 Months Ended | 12 Months Ended | ||||||||||||
Dec. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | Aug. 31, 2012 | |
Statements of Operations: | ||||||||||||||
Interest expense | $ 33,060,000 | $ 40,680,000 | $ 41,362,000 | $ 38,779,000 | $ 24,778,000 | |||||||||
Total other expense, net | (42,098,000) | (40,268,000) | (37,021,000) | (37,556,000) | (22,792,000) | |||||||||
Net loss | $ 35,123,000 | $ (11,284,000) | $ (34,838,000) | $ (59,223,000) | $ (41,568,000) | $ (45,542,000) | $ (41,389,000) | $ (33,245,000) | $ (70,222,000) | $ (161,744,000) | $ (261,297,000) | $ (238,192,000) | $ (145,335,000) | |
Net loss per share, basic and diluted (in dollars per share) | $ 0.12 | $ (0.04) | $ (0.15) | $ (0.26) | $ (0.18) | $ (0.21) | $ (0.21) | $ (0.17) | $ (0.28) | $ (0.77) | $ (1.34) | $ (1.29) | $ (0.91) | |
Statements of Comprehensive Loss: | ||||||||||||||
Comprehensive loss | $ (70,406,000) | $ (161,855,000) | $ (261,564,000) | $ (237,954,000) | $ (145,289,000) | |||||||||
Statements of Cash Flows: | ||||||||||||||
Net loss | $ 35,123,000 | $ (11,284,000) | $ (34,838,000) | $ (59,223,000) | $ (41,568,000) | $ (45,542,000) | $ (41,389,000) | $ (33,245,000) | (70,222,000) | (161,744,000) | (261,297,000) | (238,192,000) | (145,335,000) | |
Amortization of debt discount and debt issuance costs | 8,432,000 | 17,041,000 | 22,289,000 | 19,722,000 | 12,442,000 | |||||||||
Balance Sheets: | ||||||||||||||
Long-term portion of convertible notes | 0 | 337,937,000 | 0 | 337,937,000 | 223,629,000 | 301,550,000 | 291,828,000 | |||||||
Liabilities | 508,223,000 | 473,148,000 | 508,223,000 | 473,148,000 | 482,592,000 | 483,452,000 | 476,015,000 | |||||||
Additional paid-in capital | 2,072,591,000 | 1,772,123,000 | 2,072,591,000 | 1,772,123,000 | 1,591,782,000 | 1,504,052,000 | 1,489,727,000 | |||||||
Accumulated deficit | (1,983,147,000) | (1,912,925,000) | (1,983,147,000) | (1,912,925,000) | (1,751,181,000) | (1,489,884,000) | (1,251,692,000) | |||||||
Stockholders’ equity (deficit) | 89,318,000 | (140,806,000) | 89,318,000 | (140,806,000) | (159,324,000) | 14,498,000 | 238,127,000 | |||||||
Statements of Stockholders’ Equity (Deficit): | ||||||||||||||
Net loss | 35,123,000 | $ (11,284,000) | (34,838,000) | (59,223,000) | (41,568,000) | (45,542,000) | (41,389,000) | (33,245,000) | (70,222,000) | (161,744,000) | (261,297,000) | (238,192,000) | (145,335,000) | |
Additional paid-in capital | 2,072,591,000 | 1,772,123,000 | 2,072,591,000 | 1,772,123,000 | 1,591,782,000 | 1,504,052,000 | 1,489,727,000 | |||||||
Accumulated deficit | (1,983,147,000) | (1,912,925,000) | (1,983,147,000) | (1,912,925,000) | (1,751,181,000) | (1,489,884,000) | (1,251,692,000) | |||||||
Stockholders’ equity (deficit) | $ 89,318,000 | (140,806,000) | 89,318,000 | (140,806,000) | (159,324,000) | 14,498,000 | 238,127,000 | |||||||
Restatement Adjustment [Member] | ||||||||||||||
Statements of Operations: | ||||||||||||||
Net loss | $ 2,200,000 | $ 2,100,000 | $ 2,100,000 | $ 2,000,000 | $ 2,000,000 | $ 1,900,000 | ||||||||
Net loss per share, basic and diluted (in dollars per share) | $ 0.01 | $ 0.01 | $ 0.01 | $ 0.01 | $ 0.01 | $ 0.01 | ||||||||
Statements of Cash Flows: | ||||||||||||||
Net loss | $ 2,200,000 | $ 2,100,000 | $ 2,100,000 | $ 2,000,000 | $ 2,000,000 | $ 1,900,000 | ||||||||
Statements of Stockholders’ Equity (Deficit): | ||||||||||||||
Net loss | $ 2,200,000 | $ 2,100,000 | 2,100,000 | $ 2,000,000 | $ 2,000,000 | $ 1,900,000 | ||||||||
Restatement Adjustment [Member] | Correction of Amortization of Debt Discount Associated with the 2019 Notes [Member] | ||||||||||||||
Statements of Operations: | ||||||||||||||
Interest expense | (7,993,000) | (7,245,000) | (6,568,000) | (2,310,000) | ||||||||||
Total other expense, net | (7,993,000) | (7,245,000) | (6,568,000) | (2,310,000) | ||||||||||
Net loss | $ 7,993,000 | $ 7,245,000 | $ 6,568,000 | $ 2,310,000 | ||||||||||
Net loss per share, basic and diluted (in dollars per share) | $ 0.04 | $ 0.04 | $ 0.04 | $ 0.01 | ||||||||||
Statements of Comprehensive Loss: | ||||||||||||||
Comprehensive loss | $ 7,993,000 | $ 7,245,000 | $ 6,568,000 | $ 2,310,000 | ||||||||||
Statements of Cash Flows: | ||||||||||||||
Net loss | 7,993,000 | 7,245,000 | 6,568,000 | 2,310,000 | ||||||||||
Amortization of debt discount and debt issuance costs | (7,993,000) | (7,245,000) | (6,568,000) | (2,310,000) | ||||||||||
Balance Sheets: | ||||||||||||||
Accumulated deficit | 24,116,000 | 24,116,000 | 16,124,000 | 8,879,000 | 2,310,000 | |||||||||
Statements of Stockholders’ Equity (Deficit): | ||||||||||||||
Net loss | 7,993,000 | 7,245,000 | 6,568,000 | 2,310,000 | ||||||||||
Accumulated deficit | 24,116,000 | 24,116,000 | 16,124,000 | 8,879,000 | 2,310,000 | |||||||||
Restatement Adjustment [Member] | Correction of Allocation Between Additional Paid-in Capital and Convertible Notes [Member] | ||||||||||||||
Balance Sheets: | ||||||||||||||
Long-term portion of convertible notes | 36,502,000 | 36,502,000 | 44,494,000 | 51,739,000 | 58,307,000 | |||||||||
Liabilities | 36,502,000 | 36,502,000 | 44,494,000 | 51,739,000 | 58,307,000 | |||||||||
Additional paid-in capital | (60,618,000) | (60,618,000) | (60,618,000) | (60,618,000) | (60,618,000) | |||||||||
Statements of Stockholders’ Equity (Deficit): | ||||||||||||||
Additional paid-in capital | (60,618,000) | (60,618,000) | (60,618,000) | (60,618,000) | (60,618,000) | |||||||||
Restatement Adjustment [Member] | Correction of Errors Related with 2019 Notes [Member] | ||||||||||||||
Balance Sheets: | ||||||||||||||
Stockholders’ equity (deficit) | (36,502,000) | (36,502,000) | (44,494,000) | (51,739,000) | (58,307,000) | |||||||||
Statements of Stockholders’ Equity (Deficit): | ||||||||||||||
Stockholders’ equity (deficit) | $ (36,502,000) | (36,502,000) | (44,494,000) | $ (51,739,000) | $ (58,307,000) | |||||||||
Senior Subordinated Notes [Member] | 2019 Notes [Member] | ||||||||||||||
New Accounting Pronouncement, Early Adoption [Line Items] | ||||||||||||||
Debt, principal amount | $ 287,500,000 | |||||||||||||
Debt, interest rate (as a percent) | 4.25% | |||||||||||||
Statements of Cash Flows: | ||||||||||||||
Amortization of debt discount and debt issuance costs | $ 7,975,000 | $ 11,581,000 | $ 10,525,000 |
Organization and Summary of S42
Organization and Summary of Significant Accounting Policies (Estimated Useful Lives Of Property Plant And Equipment) (Details) | 12 Months Ended |
Dec. 31, 2016 | |
Equipment and Furniture [Member] | |
Property, Plant and Equipment [Line Items] | |
Estimated useful lives, years | 5 years |
Computer Equipment and Software [Member] | |
Property, Plant and Equipment [Line Items] | |
Estimated useful lives, years | 3 years |
Leasehold Improvements [Member] | Maximum [Member] | |
Property, Plant and Equipment [Line Items] | |
Estimated useful lives, years | 7 years |
Collaboration Agreements (Ipsen
Collaboration Agreements (Ipsen Collaboration) (Details) | Feb. 29, 2016USD ($) | Dec. 31, 2016USD ($) | Nov. 30, 2016USD ($) | Mar. 31, 2016USD ($) | Dec. 31, 2016USD ($)milestone | Dec. 31, 2016USD ($) | Dec. 31, 2015USD ($) |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Current portion of deferred revenue | $ 19,665,000 | $ 19,665,000 | $ 19,665,000 | $ 0 | |||
Long-term portion of deferred revenue | 237,094,000 | 237,094,000 | $ 237,094,000 | $ 0 | |||
GlaxoSmithKline [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Percent of royalty on net sale | 3.00% | ||||||
Swedish Orphan Biovitrum [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Accrued termination fee | 2,900,000 | 2,900,000 | $ 2,900,000 | ||||
Allowance for customer returns | 400,000 | 400,000 | 400,000 | ||||
Collaborative Arrangement with Ipsen [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Upfront and milestone payments | $ 200,000,000 | ||||||
Revenue recognized, milestones | 20,000,000 | ||||||
Eligible payment from collaboration for development and regulatory milestone achievement under collaborations agreement | $ 254,000,000 | ||||||
Maximum amount eligible for commercial milestones under collaborations agreement | $ 544,674,000 | ||||||
Research and development arrangement performed for others, reimbursement for costs incurred, percent | 35.00% | ||||||
Current portion of deferred revenue | 19,600,000 | 19,600,000 | 19,600,000 | ||||
Long-term portion of deferred revenue | 237,100,000 | $ 237,100,000 | 237,100,000 | ||||
Collaborative Arrangement with Ipsen [Member] | Minimum [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Percent of royalty on net sale | 22.00% | ||||||
Collaborative Arrangement with Ipsen [Member] | Maximum [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Percent of royalty on net sale | 26.00% | ||||||
Collaborative Arrangement with Ipsen [Member] | Initial [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Percent of royalty on net sale | 2.00% | ||||||
Royalty tier | $ 50,000,000 | ||||||
Collaborative Arrangement with Ipsen [Member] | Second [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Percent of royalty on net sale | 12.00% | ||||||
Royalty tier | $ 100,000,000 | ||||||
Collaborative Arrangement with Ipsen [Member] | Initial and Second [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Royalty tier | 150,000,000 | ||||||
Collaborative Arrangement with Ipsen [Member] | HCC Filing [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Eligible payment from collaboration for development and regulatory milestone achievement under collaborations agreement | 10,000,000 | ||||||
Collaborative Arrangement with Ipsen [Member] | HCC Acceptance [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Eligible payment from collaboration for development and regulatory milestone achievement under collaborations agreement | $ 40,000,000 | ||||||
Collaborative Arrangement with Ipsen, Consideration for Commercialization Rights [Member] | Canada [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Revenue recognized, milestones | $ 10,000,000 | ||||||
Collaborative Arrangement with Ipsen, Approval of Product by EC in Second-Line RCC [Member] | CABOMETYX [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Revenue recognized, milestones | $ 60,000,000 | ||||||
Collaborative Arrangement with Ipsen, Approval of Product by EC in Second-Line RCC [Member] | Germany [Member] | CABOMETYX [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Revenue recognized, milestones | $ 60,000,000 | ||||||
Collaborative Arrangement with Ipsen, First Commercial Sales of Product [Member] | CABOMETYX [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Number of milestones achieved | milestone | 2 | ||||||
Collaborative Arrangement with Ipsen, First Commercial Sales of Product [Member] | Germany [Member] | CABOMETYX [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Revenue recognized, milestones | $ 10,000,000 | ||||||
Collaborative Arrangement with Ipsen, First Commercial Sales of Product [Member] | United Kingdom [Member] | CABOMETYX [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Revenue recognized, milestones | $ 10,000,000 |
Collaboration Agreements (Colla
Collaboration Agreements (Collaboration Revenues - Ipsen) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Product supply agreement revenue | $ 135,375 | $ 34,158 | $ 25,111 |
Cost of supplied product | (6,552) | (3,895) | (2,043) |
Collaboration revenues under the collaboration agreement | 56,079 | $ 3,014 | $ 0 |
Ipsen [Member] | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Milestones achieved | 20,000 | ||
Amortization of upfront payments and deferred milestone | 13,284 | ||
Royalty revenue | 175 | ||
Product supply agreement revenue | 1,612 | ||
Cost of supplied product | (1,555) | ||
Royalty payable to GlaxoSmithKline on net sales by Ipsen | (264) | ||
Collaboration revenues under the collaboration agreement | $ 33,252 |
Collaboration Agreements (Genen
Collaboration Agreements (Genentech Collaboration) (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||
Nov. 30, 2015 | Dec. 31, 2016 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2016 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Disputed costs accrual relieved | $ (14,131,000) | $ (14,131,000) | $ (18,071,000) | $ (18,700,000) | ||
Genentech [Member] | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Percentage of share of the Company in promotions | 25.00% | |||||
Recovery of expenses, expenses prior to current fiscal year | 13,300,000 | |||||
Recovery of expenses with interest from losses recorded in prior period | $ 23,100,000 | |||||
Net cost recovery (loss) under the collaboration agreement | (4,500,000) | |||||
Genentech [Member] | Selling, general and administrative expense [Member] | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Net cost recovery (loss) under the collaboration agreement | $ 8,771,000 | $ (16,600,000) | $ (2,916,000) | |||
Genentech [Member] | Profit Sharing Tier One [Member] | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Percent of profits | 50.00% | |||||
Profit threshold | $ 200,000,000 | |||||
Genentech [Member] | Profit Sharing Tier Two [Member] | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Percent of profits | 30.00% | |||||
Profit threshold | $ 400,000,000 |
Collaboration Agreements (Col46
Collaboration Agreements (Collaboration Revenues - Genentech) (Details) - Genentech [Member] - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
(Loss) net cost recovery under the collaboration agreement included in Selling, general and administrative expenses | $ (4,500) | ||
Selling, general and administrative expense [Member] | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
(Loss) net cost recovery under the collaboration agreement included in Selling, general and administrative expenses | 8,771 | $ (16,600) | $ (2,916) |
COTELLIC [Member] | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Royalty revenues on ex-U.S. sales of COTELLIC | $ 2,827 | $ 14 | $ 0 |
Collaboration Agreements (Other
Collaboration Agreements (Other Collaborations) (Details) | 3 Months Ended | 12 Months Ended | |||
Sep. 30, 2016USD ($) | Mar. 31, 2016USD ($) | Dec. 31, 2016USD ($)product | Dec. 31, 2015USD ($) | Dec. 31, 2014USD ($) | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Maximum potential milestone payments | $ 2,200,000,000 | ||||
Percentage of maximum potential milestone payments - clinical development | 9.00% | ||||
Percentage of maximum potential milestone payments - regulatory | 42.00% | ||||
Percentage of maximum potential milestone payments - commercial | 49.00% | ||||
GlaxoSmithKline [Member] | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Percent of royalty on net sales | 3.00% | ||||
Daiichi Sankyo [Member] | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Maximum amount eligible for development and regulatory milestones | $ 130,000,000 | ||||
Revenue recognized, milestones | $ 15,000,000 | 15,000,000 | $ 0 | $ 0 | |
Merck [Member] | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Maximum amount eligible for development and regulatory milestones | 231,000,000 | ||||
Revenue recognized, milestones | $ 5,000,000 | 5,000,000 | 3,000,000 | 0 | |
Maximum amount eligible for royalties on sales under collaborations agreement | 375,000,000 | ||||
Bristol Myers Squibb [Member] | ROR Collaboration Agreement [Member] | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Maximum amount eligible for development and regulatory milestones | 252,500,000 | ||||
Revenue recognized, milestones | 0 | 0 | |||
Maximum amount eligible for commercial milestones under collaborations agreement | 150,000,000 | ||||
Bristol Myers Squibb [Member] | LXR Collaboration [Member] | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Maximum amount eligible for development and regulatory milestones | 53,000,000 | ||||
Revenue recognized, milestones | 0 | 0 | |||
Maximum amount eligible for royalties on sales under collaborations agreement | $ 310,000,000 | ||||
Bristol Myers Squibb [Member] | LXR Collaboration [Member] | Maximum [Member] | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Number of products subject to maximum contingent consideration | product | 2 | ||||
Sanofi [Member] | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Maximum amount eligible for development and regulatory milestones | $ 745,000,000 | ||||
Revenue recognized, milestones | 0 | 0 | |||
GlaxoSmithKline [Member] | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Royalty expense | $ 4,300,000 | $ 1,000,000 | $ 700,000 |
Restructurings (Narrative) (Det
Restructurings (Narrative) (Details) $ in Thousands | 12 Months Ended | 28 Months Ended | 39 Months Ended | 46 Months Ended | 82 Months Ended | |||
Dec. 31, 2016USD ($) | Dec. 31, 2015USD ($) | Dec. 31, 2014USD ($)employee | Dec. 31, 2016USD ($) | May 31, 2013restructuring | Dec. 31, 2013USD ($) | Dec. 31, 2016USD ($) | Jun. 30, 2010employee | |
Restructuring Cost and Reserve [Line Items] | ||||||||
Restructuring charges | $ 914 | $ 1,042 | $ 7,596 | $ 62,834 | ||||
Restructuring accrual | 1,940 | 4,590 | 10,791 | $ 1,940 | $ 13,472 | 1,940 | ||
Facility Charges [Member] | ||||||||
Restructuring Cost and Reserve [Line Items] | ||||||||
Restructuring charges | 800 | 1,582 | ||||||
Recovery related to a new sublease | 100 | |||||||
Restructuring accrual | 1,900 | 1,900 | 1,900 | |||||
Asset Impairment and Sales [Member] | ||||||||
Restructuring Cost and Reserve [Line Items] | ||||||||
Restructuring charges | (1,000) | |||||||
Employee Severance and Other Benefits [Member] | ||||||||
Restructuring Cost and Reserve [Line Items] | ||||||||
Restructuring charges | 5,775 | |||||||
Property and Equipment Write-downs and Other Charges [Member] | ||||||||
Restructuring Cost and Reserve [Line Items] | ||||||||
Restructuring charges | 344 | |||||||
2010 Restructurings [Member] | ||||||||
Restructuring Cost and Reserve [Line Items] | ||||||||
Number of restructurings implemented | restructuring | 5 | |||||||
Aggregate reduction in headcount (in employees) | employee | 429 | |||||||
2010 Restructurings [Member] | Facility Charges [Member] | ||||||||
Restructuring Cost and Reserve [Line Items] | ||||||||
Restructuring charges | 902 | 757 | 1,626 | 32,517 | ||||
Restructuring accrual | 1,925 | 4,087 | 9,454 | 1,925 | 13,460 | 1,925 | ||
2010 Restructurings [Member] | Employee Severance and Other Benefits [Member] | ||||||||
Restructuring Cost and Reserve [Line Items] | ||||||||
Restructuring charges | 21,700 | |||||||
2010 Restructurings [Member] | Property and Equipment Write-downs and Other Charges [Member] | ||||||||
Restructuring Cost and Reserve [Line Items] | ||||||||
Restructuring charges | 0 | 0 | (117) | 23,933 | ||||
Restructuring accrual | 0 | 0 | $ 0 | 0 | 12 | 0 | ||
2014 Restructuring [Member] | ||||||||
Restructuring Cost and Reserve [Line Items] | ||||||||
Aggregate reduction in headcount (in employees) | employee | 143 | |||||||
2014 Restructuring [Member] | Facility Charges [Member] | ||||||||
Restructuring Cost and Reserve [Line Items] | ||||||||
Restructuring charges | 12 | $ 65 | 1,659 | |||||
Restructuring accrual | 15 | 503 | 0 | 15 | 0 | 15 | ||
2014 Restructuring [Member] | Employee Severance and Other Benefits [Member] | ||||||||
Restructuring Cost and Reserve [Line Items] | ||||||||
Restructuring charges | 0 | (269) | 5,506 | |||||
Restructuring accrual | 0 | 0 | 1,290 | 0 | 0 | 0 | ||
2014 Restructuring [Member] | Property and Equipment Write-downs and Other Charges [Member] | ||||||||
Restructuring Cost and Reserve [Line Items] | ||||||||
Restructuring charges | 0 | (1,028) | 247 | (781) | ||||
Restructuring accrual | $ 0 | $ 0 | $ 47 | $ 0 | $ 0 | $ 0 |
Restructurings (Schedule of Out
Restructurings (Schedule of Outstanding Restructuring Liability) (Details) - USD ($) $ in Thousands | 12 Months Ended | 28 Months Ended | 46 Months Ended | 82 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2016 | Dec. 31, 2013 | Dec. 31, 2016 | |
Restructuring Reserve [Roll Forward] | ||||||
Restructuring liability at beginning of period | $ 4,590 | $ 10,791 | $ 13,472 | |||
Restructuring charge (recovery) | 914 | 1,042 | 7,596 | $ 62,834 | ||
Proceeds from sale of assets | 1,325 | 299 | ||||
Other cash payments, net | (4,573) | (8,827) | (10,236) | |||
Other items | 1,009 | 259 | (340) | |||
Restructuring liability at end of period | 1,940 | 4,590 | 10,791 | $ 1,940 | $ 13,472 | 1,940 |
Employee Severance and Other Benefits [Member] | ||||||
Restructuring Reserve [Roll Forward] | ||||||
Restructuring charge (recovery) | 5,775 | |||||
Facility Charges [Member] | ||||||
Restructuring Reserve [Roll Forward] | ||||||
Restructuring charge (recovery) | 800 | 1,582 | ||||
Restructuring liability at end of period | 1,900 | 1,900 | 1,900 | |||
Other [Member] | ||||||
Restructuring Reserve [Roll Forward] | ||||||
Restructuring charge (recovery) | 344 | |||||
2010 Restructurings [Member] | Employee Severance and Other Benefits [Member] | ||||||
Restructuring Reserve [Roll Forward] | ||||||
Restructuring charge (recovery) | 21,700 | |||||
2010 Restructurings [Member] | Facility Charges [Member] | ||||||
Restructuring Reserve [Roll Forward] | ||||||
Restructuring liability at beginning of period | 4,087 | 9,454 | 13,460 | |||
Restructuring charge (recovery) | 902 | 757 | 1,626 | 32,517 | ||
Proceeds from sale of assets | 0 | 0 | ||||
Other cash payments, net | (4,039) | (6,449) | (5,644) | |||
Other items | 975 | 325 | 12 | |||
Restructuring liability at end of period | 1,925 | 4,087 | 9,454 | 1,925 | 13,460 | 1,925 |
2010 Restructurings [Member] | Other [Member] | ||||||
Restructuring Reserve [Roll Forward] | ||||||
Restructuring liability at beginning of period | 0 | 0 | 12 | |||
Restructuring charge (recovery) | 0 | 0 | (117) | 23,933 | ||
Proceeds from sale of assets | 0 | 199 | ||||
Other cash payments, net | 0 | 0 | (8) | |||
Other items | 0 | 0 | (86) | |||
Restructuring liability at end of period | 0 | 0 | 0 | 0 | 12 | 0 |
2014 Restructuring [Member] | Employee Severance and Other Benefits [Member] | ||||||
Restructuring Reserve [Roll Forward] | ||||||
Restructuring liability at beginning of period | 0 | 1,290 | 0 | |||
Restructuring charge (recovery) | 0 | (269) | 5,506 | |||
Proceeds from sale of assets | 0 | 0 | ||||
Other cash payments, net | 0 | (1,021) | (4,507) | |||
Other items | 0 | 0 | 22 | |||
Restructuring liability at end of period | 0 | 0 | 1,290 | 0 | 0 | 0 |
2014 Restructuring [Member] | Facility Charges [Member] | ||||||
Restructuring Reserve [Roll Forward] | ||||||
Restructuring liability at beginning of period | 503 | 0 | 0 | |||
Restructuring charge (recovery) | 12 | 65 | 1,659 | |||
Proceeds from sale of assets | 0 | 0 | ||||
Other cash payments, net | (500) | (1,357) | (65) | |||
Other items | 0 | 278 | 0 | |||
Restructuring liability at end of period | 15 | 503 | 0 | 15 | 0 | 15 |
2014 Restructuring [Member] | Other [Member] | ||||||
Restructuring Reserve [Roll Forward] | ||||||
Restructuring liability at beginning of period | 0 | 47 | 0 | |||
Restructuring charge (recovery) | 0 | (1,028) | 247 | (781) | ||
Proceeds from sale of assets | 1,325 | 100 | ||||
Other cash payments, net | (34) | 0 | (12) | |||
Other items | 34 | (344) | (288) | |||
Restructuring liability at end of period | $ 0 | $ 0 | $ 47 | $ 0 | $ 0 | $ 0 |
Cash and Investments (Summary b
Cash and Investments (Summary by Balance Sheet Line Item) (Details) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Investment [Line Items] | ||
Amortized Cost | $ 479,862 | $ 253,433 |
Gross Unrealized Gains | 14 | 7 |
Gross Unrealized Losses | (322) | (130) |
Fair Value | 479,554 | 253,310 |
Cash and cash equivalents [Member] | ||
Investment [Line Items] | ||
Amortized Cost | 151,686 | 141,634 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | 151,686 | 141,634 |
Short-term investments [Member] | ||
Investment [Line Items] | ||
Amortized Cost | 268,234 | 25,484 |
Gross Unrealized Gains | 13 | 5 |
Gross Unrealized Losses | (130) | (63) |
Fair Value | 268,117 | 25,426 |
Long-term investments [Member] | ||
Investment [Line Items] | ||
Amortized Cost | 55,792 | 83,665 |
Gross Unrealized Gains | 1 | 2 |
Gross Unrealized Losses | (192) | (67) |
Fair Value | 55,601 | 83,600 |
Long-term restricted investments [Member] | ||
Investment [Line Items] | ||
Amortized Cost | 4,150 | 2,650 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | $ 4,150 | $ 2,650 |
Cash and Investments (Narrative
Cash and Investments (Narrative) (Details) | 12 Months Ended | ||
Dec. 31, 2016USD ($)accountinvestmentaffiliate | Dec. 31, 2015USD ($) | Dec. 31, 2014USD ($) | |
Investment [Line Items] | |||
Number of required investment accounts | account | 1 | ||
Number of affiliate banks | affiliate | 1 | ||
Gain (loss) on sale of available-for-sale securities | $ 0 | $ 0 | $ 0 |
Other-than-temporary impairment charges on available-for-sale securities | $ 0 | 0 | 0 |
Number of investments in unrealized loss position | investment | 86 | ||
Gross unrealized losses | $ (322,000) | (130,000) | |
Unrealized loss position, aggregate fair value | 172,100,000 | ||
Realized gain on sale of cost method investment | 0 | $ 0 | |
Carrying value of cost method investments | 0 | 0 | |
Akarna Therapeutics, Ltd. [Member] | |||
Investment [Line Items] | |||
Realized gain on sale of cost method investment | $ 2,500,000 | ||
Cost method investment ownership percentage | 9.00% | ||
Corporate Bonds [Member] | |||
Investment [Line Items] | |||
Gross unrealized losses | $ (308,000) | (118,000) | |
Unrealized loss position, aggregate fair value | 143,500,000 | ||
Silicon Valley Bank Term Loan and Line of Credit [Member] | |||
Investment [Line Items] | |||
Collateral balance | $ 81,600,000 | $ 81,600,000 |
Cash and Investments (Summary52
Cash and Investments (Summary by Security Type) (Details) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Investment [Line Items] | ||
Amortized Cost | $ 460,274 | $ 250,810 |
Gross Unrealized Gains | 14 | 7 |
Gross Unrealized Losses | (322) | (130) |
Fair Value | 459,966 | 250,687 |
Money market funds [Member] | ||
Investment [Line Items] | ||
Amortized Cost | 71,457 | 72,000 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | 71,457 | 72,000 |
Commercial paper [Member] | ||
Investment [Line Items] | ||
Amortized Cost | 165,375 | 78,155 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | 165,375 | 78,155 |
Corporate bonds [Member] | ||
Investment [Line Items] | ||
Amortized Cost | 152,712 | 72,205 |
Gross Unrealized Gains | 3 | 4 |
Gross Unrealized Losses | (308) | (118) |
Fair Value | 152,407 | 72,091 |
U.S. Treasury and government sponsored enterprises [Member] | ||
Investment [Line Items] | ||
Amortized Cost | 70,730 | 28,434 |
Gross Unrealized Gains | 11 | 1 |
Gross Unrealized Losses | (14) | (12) |
Fair Value | $ 70,727 | 28,423 |
Marketable equity securities [Member] | ||
Investment [Line Items] | ||
Amortized Cost | 16 | |
Gross Unrealized Gains | 2 | |
Gross Unrealized Losses | 0 | |
Fair Value | $ 18 |
Cash and Investments (Available
Cash and Investments (Available for Sale by Contractual Maturity) (Details) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Schedule of Available-for-sale Securities [Line Items] | ||
Fair Value | $ 459,966 | $ 250,687 |
Money market funds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Mature within One Year | 71,457 | |
After One Year through Two Years | 0 | |
Fair Value | 71,457 | 72,000 |
Commercial paper [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Mature within One Year | 165,375 | |
After One Year through Two Years | 0 | |
Fair Value | 165,375 | 78,155 |
Corporate bonds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Mature within One Year | 99,455 | |
After One Year through Two Years | 52,952 | |
Fair Value | 152,407 | 72,091 |
U.S. Treasury and government sponsored enterprises [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Mature within One Year | 68,078 | |
After One Year through Two Years | 2,649 | |
Fair Value | 70,727 | $ 28,423 |
Total [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Mature within One Year | 404,365 | |
After One Year through Two Years | 55,601 | |
Fair Value | $ 459,966 |
Inventory (Details)
Inventory (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 863 | $ 1,037 |
Work in process | 2,343 | 2,251 |
Finished goods | 738 | 583 |
Total | 3,944 | 3,871 |
Less: non-current portion included in Other long-term assets | (606) | (1,255) |
Inventory | 3,338 | 2,616 |
Inventory write-down | $ 500 | $ 1,200 |
Property and Equipment (Schedul
Property and Equipment (Schedule of Property and Equipment) (Details) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 26,953 | $ 25,743 |
Less: accumulated depreciation and amortization | (24,882) | (24,309) |
Property and equipment, net | 2,071 | 1,434 |
Laboratory Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 4,310 | 4,749 |
Computer Equipment and Software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 13,738 | 11,890 |
Furniture and Fixtures [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 2,240 | 2,253 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 6,646 | 6,395 |
Construction in Progress [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 19 | $ 456 |
Property and Equipment (Narrati
Property and Equipment (Narrative) (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Property, Plant and Equipment [Abstract] | |||
Depreciation | $ 1,000,000 | $ 1,400,000 | $ 2,400,000 |
Impairment charges | 0 | 0 | 700,000 |
Gain on sale of excess equipment | 0 | 1,000,000 | 600,000 |
Proceeds from sale of property and equipment | $ 97,000 | $ 1,346,000 | $ 392,000 |
Debt (Schedule of Debt) (Detail
Debt (Schedule of Debt) (Details) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Debt Instrument [Line Items] | ||
Total debt | $ 189,122 | $ 417,937 |
Less: current portion | (189,122) | 0 |
Long-term debt | 0 | 417,937 |
Secured Notes [Member] | Deerfield Notes [Member] | ||
Debt Instrument [Line Items] | ||
Total debt | 109,122 | 102,727 |
Term Loan [Member] | ||
Debt Instrument [Line Items] | ||
Total debt | 80,000 | |
Senior Subordinated Notes [Member] | 2019 Notes [Member] | ||
Debt Instrument [Line Items] | ||
Total debt | $ 0 | $ 235,210 |
Debt (Deerfield Notes) (Details
Debt (Deerfield Notes) (Details) - USD ($) | Jul. 01, 2015 | Mar. 18, 2015 | Jan. 22, 2014 | Jan. 31, 2016 | Jan. 31, 2015 | Jan. 31, 2014 | Jun. 30, 2010 | Dec. 31, 2016 | Dec. 31, 2015 |
Warrants Issued in January 2014 [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Warrant period | 2 years | 2 years | 2 years | 2 years | |||||
Warrants outstanding (in shares) | 1,000,000 | 1,000,000 | |||||||
Exercise price per share (in dollars per share) | $ 3.445 | $ 3.445 | $ 9.70 | $ 9.70 | |||||
Secured Notes [Member] | Deerfield Notes [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Debt, principal amount | $ 124,000,000 | ||||||||
Debt instruments, purchase price | 80,000,000 | ||||||||
Debt issuance costs | 2,000,000 | ||||||||
Amendment, consent fee | $ 1,500,000 | ||||||||
Periodic payment, principal | $ 4,000,000 | ||||||||
Principal eligible for extension option | 100,000,000 | ||||||||
Convertible debt | $ 109,800,000 | $ 103,800,000 | |||||||
Interest rate after extension option election (as a percent) | 15.00% | ||||||||
Annual interest | $ 6,000,000 | ||||||||
Prepayment price (as a percent) | 105.00% | ||||||||
Balance of unamortized closing fees and expenses | $ 400,000 | $ 700,000 | |||||||
Effective interest rate (as a percent) | 15.20% | ||||||||
Percentage of revenues payable under collaborative arrangements (as a percent) | 15.00% | 15.00% | |||||||
Maximum prepayment amount under collaborative arrangements | $ 27,500,000 | ||||||||
Debt instrument, minimum purchase amount for prepayment condition | $ 400,000,000 | ||||||||
Percentage of assets minimum for prepayment condition | 50.00% | ||||||||
Mandatory payments upon sale of intellectual property (as a percent of sales) | 100.00% | ||||||||
Mandatory payments upon sale of other intellectual property (as a percent of sales) | 50.00% | ||||||||
Secured Notes [Member] | Deerfield Notes [Member] | Coupon Interest [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Interest rate after extension option election (as a percent) | 7.50% | ||||||||
Secured Notes [Member] | Deerfield Notes [Member] | Payment-in-Kind Interest [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Interest rate after extension option election (as a percent) | 7.50% |
Debt (Interest Expense on Deerf
Debt (Interest Expense on Deerfield Notes) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Debt Instrument [Line Items] | |||||
Interest paid in kind | $ 8,008 | $ 3,817 | $ 0 | ||
Amortization of debt discount and debt issuance costs | 8,432 | 17,041 | 22,289 | $ 19,722 | $ 12,442 |
Secured Notes [Member] | Deerfield Notes [Member] | |||||
Debt Instrument [Line Items] | |||||
Stated coupon interest | 8,008 | 6,792 | 6,000 | ||
Interest paid in kind | 8,008 | 3,817 | 0 | ||
Amortization of debt discount and debt issuance costs | 457 | 5,461 | 11,731 | ||
Total interest expense | $ 16,473 | $ 16,070 | $ 17,731 |
Debt (Silicon Valley Bank Loan
Debt (Silicon Valley Bank Loan and Security Agreement) (Details) $ in Thousands | Jun. 02, 2010payment | Dec. 31, 2016USD ($) | Dec. 31, 2015USD ($) |
Debt Instrument [Line Items] | |||
Outstanding principal amount | $ 189,122 | $ 417,937 | |
Silicon Valley Bank Term Loan and Line of Credit [Member] | |||
Debt Instrument [Line Items] | |||
Collateral balance | 81,600 | 81,600 | |
Term Loan [Member] | |||
Debt Instrument [Line Items] | |||
Outstanding principal amount | 80,000 | ||
Term Loan [Member] | Silicon Valley Bank Term Loan and Line of Credit [Member] | |||
Debt Instrument [Line Items] | |||
Debt instrument, term | 7 years | ||
Outstanding principal amount | $ 80,000 | $ 80,000 | |
Debt, interest rate (as a percent) | 1.00% | 6.00% | |
Number of balloon payments | payment | 1 | ||
Principal balance payable in balloon payment | 100.00% | ||
Percentage of security deposit on outstanding obligations | 100.00% | ||
Maximum percentage required for collateral balance | 107.00% |
Debt (2019 Notes) (Details)
Debt (2019 Notes) (Details) | Nov. 30, 2016USD ($) | Nov. 02, 2016 | Aug. 19, 2016USD ($)shares | Aug. 31, 2012USD ($) | Nov. 30, 2016USD ($)shares | Dec. 31, 2016USD ($)shares | Dec. 31, 2015USD ($) | Dec. 31, 2014USD ($) | Aug. 24, 2016USD ($) |
Debt Instrument [Line Items] | |||||||||
Aggregate principal amount of debt converted | $ 286,900,000 | ||||||||
Loss on extinguishment of debt | (13,901,000) | $ 0 | $ 0 | ||||||
Issuance of common stock in settlement of convertible notes | $ 253,080,000 | ||||||||
Senior Subordinated Notes [Member] | 2019 Notes [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Debt, principal amount | $ 287,500,000 | ||||||||
Proceeds from convertible debt | $ 277,700,000 | ||||||||
Debt, interest rate (as a percent) | 4.25% | ||||||||
Aggregate principal amount of debt converted | $ 239,400,000 | $ 47,500,000 | |||||||
Number of shares issued pursuant to conversion | shares | 45,064,455 | 8,944,824 | 54,009,279 | ||||||
Inducements in conversion | $ 6,000,000 | ||||||||
Cash inducements | 2,400,000 | ||||||||
Repayments of interest required upon a conversion under the terms of the indenture that were not repaid under the terms of the exchange agreements | $ 3,600,000 | ||||||||
Redemption of convertible debt | $ 600,000 | $ 600,000 | $ 48,100,000 | ||||||
Convertible debt, conversion ratio | 0.1882352 | ||||||||
Loss on extinguishment of debt | $ (7,300,000) | ||||||||
Issuance of common stock in settlement of convertible notes | $ 592,700,000 | ||||||||
Reduction of additional paid-in capital resulting from conversion | 342,700,000 | ||||||||
Redemption price (as a percent) | 100.00% | ||||||||
Loss on extinguishment of debt, transaction costs incurred with third parties | 500,000 | ||||||||
Reduction of additional paid-in capital related with transaction costs | 700,000 | ||||||||
Balance of unamortized closing fees and expenses | $ 0 | $ 4,200,000 | |||||||
Redemption, percentage of principal amount redeemed | 100.00% |
Debt (Loss on Extinguishment of
Debt (Loss on Extinguishment of Debt) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Inducements included in August 9, 2016 and August 19, 2016 agreements: | |||
Loss on extinguishment of debt | $ 13,901 | $ 0 | $ 0 |
Senior Subordinated Notes [Member] | 2019 Notes [Member] | |||
Inducements included in August 9, 2016 and August 19, 2016 agreements: | |||
Cash inducements | 2,394 | ||
Repayments of interest required upon a conversion under the terms of the indenture that were not repaid under the terms of the exchange agreements | 3,572 | ||
Difference between the total settlement consideration attributed to the liability component of the 2019 Notes and the net carrying value of the liability, described above | 7,338 | ||
Unamortized discount on redeemed notes | 83 | ||
Third party costs | 514 | ||
Loss on extinguishment of debt | $ 13,901 |
Debt (Interest Expense on 2019
Debt (Interest Expense on 2019 Notes) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Debt Instrument [Line Items] | |||||
Amortization of debt discount and debt issuance costs | $ 8,432 | $ 17,041 | $ 22,289 | $ 19,722 | $ 12,442 |
Senior Subordinated Notes [Member] | 2019 Notes [Member] | |||||
Debt Instrument [Line Items] | |||||
Stated coupon interest | 7,799 | 12,218 | 12,253 | ||
Amortization of debt discount and debt issuance costs | 7,975 | 11,581 | 10,525 | ||
Total interest expense | $ 15,774 | $ 23,799 | $ 22,778 |
Debt (Future Principal Payments
Debt (Future Principal Payments of Total Long-term Debt) (Details) $ in Thousands | Dec. 31, 2016USD ($) |
Debt Disclosure [Abstract] | |
2,017 | $ 80,000 |
2,018 | 124,972 |
Thereafter | $ 0 |
Common Stock and Warrants (Deta
Common Stock and Warrants (Details) - USD ($) $ / shares in Units, $ in Thousands | Aug. 19, 2016 | Jul. 01, 2015 | Mar. 18, 2015 | Jan. 22, 2014 | Jul. 31, 2015 | Jan. 31, 2014 | Nov. 30, 2016 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 |
Class of Warrant or Right [Line Items] | ||||||||||
Aggregate principal amount of debt converted | $ 286,900 | |||||||||
Increase to shareholder's equity | 253,080 | |||||||||
Loss on extinguishment of debt | (13,901) | $ 0 | $ 0 | |||||||
Public offering of common stock (in shares) | 28,750,000 | 10,000,000 | ||||||||
Share price (in dollars per share) | $ 5.40 | $ 8 | ||||||||
Net proceeds from public offering | $ 145,600 | $ 75,600 | $ 0 | 145,649 | 75,643 | |||||
Warrants Issued in January 2014 [Member] | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Warrant period | 2 years | 2 years | 2 years | 2 years | ||||||
Warrants outstanding (in shares) | 1,000,000 | 1,000,000 | ||||||||
Exercise price per share (in dollars per share) | $ 3.445 | $ 3.445 | $ 9.70 | $ 9.70 | ||||||
Maximum shares outstanding single holder may beneficially own (as a percent) | 9.98% | |||||||||
Fair Value of warrants | $ 1,500 | 900 | ||||||||
Unrealized gain (loss) on warrants | $ (500) | $ 1,800 | ||||||||
Over-Allotment Option [Member] | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Public offering of common stock (in shares) | 3,750,000 | |||||||||
Senior Subordinated Notes [Member] | 2019 Notes [Member] | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Number of shares issued pursuant to conversion | 45,064,455 | 8,944,824 | 54,009,279 | |||||||
Aggregate principal amount of debt converted | $ 239,400 | $ 47,500 | ||||||||
Increase to shareholder's equity | $ 592,700 | |||||||||
Loss on extinguishment of debt | $ (7,300) |
Fair Value Measurements (Schedu
Fair Value Measurements (Schedule of Fair Value of Financial Assets Measured on A Recurring Basis) (Details) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | $ 459,966 | $ 250,687 |
Money market funds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 71,457 | 72,000 |
Commercial paper [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 165,375 | 78,155 |
Corporate bonds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 152,407 | 72,091 |
U.S. Treasury and government sponsored enterprises [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 70,727 | 28,423 |
Marketable equity securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 18 | |
Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 71,457 | 72,018 |
Level 1 [Member] | Money market funds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 71,457 | 72,000 |
Level 1 [Member] | Commercial paper [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 0 | 0 |
Level 1 [Member] | Corporate bonds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total 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 financial assets | 0 | 0 |
Level 1 [Member] | Marketable equity securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 18 | |
Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 388,509 | 178,669 |
Level 2 [Member] | Money market funds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 0 | 0 |
Level 2 [Member] | Commercial paper [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 165,375 | 78,155 |
Level 2 [Member] | Corporate bonds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 152,407 | 72,091 |
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 financial assets | $ 70,727 | 28,423 |
Level 2 [Member] | Marketable equity securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | $ 0 |
Fair Value Measurements (Fair V
Fair Value Measurements (Fair Value Schedule of Level 3 Changes) (Details) - Level 3 [Member] $ in Thousands | 12 Months Ended |
Dec. 31, 2015USD ($) | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |
Balance at December 31, 2014 | $ 921 |
Unrealized loss at final re-measurement of warrants on March 18, 2015, included in Interest income and other, net | 549 |
Transfer of warrants from Other long-term liabilities to Additional paid-in capital at their estimated fair value upon warrant repricing on March 18, 2015 | (1,470) |
Balance at December 31, 2015 | $ 0 |
Fair Value Measurements (Sche68
Fair Value Measurements (Schedule of Estimated Fair Value of Outstanding Debt) (Details) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Carrying Amount [Member] | Secured Notes [Member] | Deerfield Notes [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Long-term debt | $ 109,122 | $ 102,727 |
Carrying Amount [Member] | Term Loan [Member] | Silicon Valley Bank Loan and Security Agreement [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Long-term debt | 80,000 | 80,000 |
Carrying Amount [Member] | Senior Subordinated Notes [Member] | 2019 Notes [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Long-term debt | 0 | 235,210 |
Fair Value [Member] | Secured Notes [Member] | Deerfield Notes [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Long-term debt | 121,220 | 101,096 |
Fair Value [Member] | Term Loan [Member] | Silicon Valley Bank Loan and Security Agreement [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Long-term debt | 79,784 | 79,815 |
Fair Value [Member] | Senior Subordinated Notes [Member] | 2019 Notes [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Long-term debt | $ 0 | $ 336,260 |
Fair Value Measurements (Narrat
Fair Value Measurements (Narrative) (Details) - Level 3 [Member] | 9 Months Ended | 12 Months Ended |
Sep. 30, 2016 | Dec. 31, 2016 | |
Deerfield Notes [Member] | Deerfield Notes [Member] | ||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | ||
Fair value inputs, discount rate | 9.50% | |
Senior Subordinated Notes [Member] | 2019 Notes [Member] | ||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | ||
Fair value inputs, discount rate | 9.50% |
Employee Equity and Benefit P70
Employee Equity and Benefit Plans (Narrative) (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |||
Dec. 31, 2005 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2010 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock-based compensation expense | $ 22,912,000 | $ 21,977,000 | $ 10,006,000 | ||
Fair value of employee options vested and expensed | 13,400,000 | 18,900,000 | 8,600,000 | ||
Cash received from option exercises and purchases under the ESPP | $ 27,500,000 | 11,500,000 | 1,600,000 | ||
Retirement Plan, employee contribution (as a percent) | 50.00% | ||||
Employer matching contributions for first 3% of participant contributions (as a percent) | 100.00% | ||||
Percentage of participant contributions into the 401(k) Retirement Plan (as a percent) | 3.00% | ||||
Expenses relating to stock match | $ 1,100,000 | 400,000 | 1,100,000 | ||
Shares available for issuance under 401 (k) Retirement Plan | 303,187 | ||||
Change in Control and Severance Benefit Plan [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Termination period prior to change in control | 1 month | ||||
Termination period subsequent to change in control | 13 months | ||||
Change in Control and Severance Benefit Plan [Member] | Maximum [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Extension of exercise period | 1 year | ||||
Stock Options [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock options, vesting period | 4 years | 10 years | |||
Life of stock options granted | 7 years | ||||
Number of shares available for grant | 1,630,271 | ||||
Intrinsic value of options exercised | $ 50,000,000 | 2,900,000 | |||
Total unrecognized compensation expense | $ 23,900,000 | ||||
Unrecognized compensation expense weighted-average period for recognition | 2 years 10 months 24 days | ||||
ESPP [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Discount rate from market value on purchase date (as a percent) | 85.00% | ||||
Discount rate from market value on offering date (as a percent) | 85.00% | ||||
Purchase period | 6 months | ||||
Stock-based compensation expense | $ 1,000,000 | $ 400,000 | $ 800,000 | ||
Number of shares available for grant | 5,487,023 | ||||
Common stock issued (in shares) | 559,936 | 324,315 | 669,565 | ||
Average price per share (in dollars per share) | $ 3.91 | $ 1.75 | $ 2.14 | ||
Performance Stock Options [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock-based compensation expense | $ 4,100,000 | $ 13,200,000 | $ 0 | ||
Number of options in vested (in shares) | 5,870,303 | 6,982,613 | |||
RSUs [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock options, vesting period | 4 years | ||||
Total unrecognized compensation expense | $ 13,900,000 | ||||
Unrecognized compensation expense weighted-average period for recognition | 3 years 3 months 10 days |
Employee Equity and Benefit P71
Employee Equity and Benefit Plans (Schedule of Allocated Employee Stock-Based Compensation Expense) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Total employee stock-based compensation expense | $ 22,912 | $ 21,977 | $ 10,006 |
Research and development expense [Member] | |||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Total employee stock-based compensation expense | 9,366 | 11,691 | 3,245 |
Selling, general and administrative expense [Member] | |||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Total employee stock-based compensation expense | 13,546 | 10,286 | 6,783 |
Restructuring related recovery [Member] | |||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Total employee stock-based compensation expense | $ 0 | $ 0 | $ (22) |
Employee Equity and Benefit P72
Employee Equity and Benefit Plans (Weighted Average Grant Date Fair Value) (Details) - $ / shares | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Stock Options [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Weighted average grant-date fair value (in dollars per share) | $ 4.77 | $ 2.55 | $ 1.46 |
ESPP [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Weighted average grant-date fair value (in dollars per share) | $ 2.17 | $ 1.20 | $ 1.28 |
Employee Equity and Benefit P73
Employee Equity and Benefit Plans (Schedule of Fair Value of Employee Share-Based Payments Awards ESPP Assumptions and Weighted Average Fair Values) (Details) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Stock Options [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Risk-free interest rate | 1.15% | 1.22% | 1.80% |
Dividend yield | 0.00% | 0.00% | 0.00% |
Volatility | 76.00% | 93.00% | 85.00% |
Expected life | 4 years 4 months 9 days | 4 years 6 months | 5 years 6 months |
ESPP [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Risk-free interest rate | 0.55% | 0.15% | 0.06% |
Dividend yield | 0.00% | 0.00% | 0.00% |
Volatility | 65.00% | 98.00% | 69.00% |
Expected life | 6 months | 6 months | 6 months |
Employee Equity and Benefit P74
Employee Equity and Benefit Plans (Summary of All Stock Option Activity) (Details) $ / shares in Units, $ in Thousands | 12 Months Ended |
Dec. 31, 2016USD ($)$ / sharesshares | |
Shares | |
Options outstanding at beginning of the year (in shares) | shares | 27,425,854 |
Granted (in shares) | shares | 4,200,950 |
Exercised (in shares) | shares | (6,239,022) |
Forfeited (in shares) | shares | (307,601) |
Expired (in shares) | shares | (80,516) |
Options outstanding at ending of the year (in shares) | shares | 24,999,665 |
Exercisable at December 31, 2016 (in shares) | shares | 17,731,361 |
Weighted Average Exercise Price | |
Options outstanding at beginning of the year (in dollars per share) | $ / shares | $ 4.22 |
Granted (in dollars per share) | $ / shares | 8.29 |
Exercised (in dollars per share) | $ / shares | 4.07 |
Forfeited (in dollars per share) | $ / shares | 4.67 |
Expired (in dollars per share) | $ / shares | 10.49 |
Options outstanding at ending of the year (in dollars per share) | $ / shares | 4.91 |
Exercisable at December 31, 2016 (in dollars per share) | $ / shares | $ 4.01 |
Weighted Average Remaining Contractual Term, Options outstanding at December 31, 2016 | 4 years 6 months 14 days |
Weighted Average Remaining Contractual Term, Exercisable at December 31, 2016 | 3 years 11 months 23 days |
Aggregate Intrinsic Value, Options outstanding at December 31, 2016 | $ | $ 250,996 |
Aggregate Intrinsic Value, Exercisable at December 31, 2016 | $ | $ 193,288 |
Employee Equity and Benefit P75
Employee Equity and Benefit Plans (Summary of Information About Stock Options Outstanding) (Details) | 12 Months Ended |
Dec. 31, 2016$ / sharesshares | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Options Outstanding, Number (in shares) | shares | 24,999,665 |
Options Outstanding, Weighted Average Remaining Contractual Life (in years) | 4 years 6 months 14 days |
Options Outstanding, Weighted Average Exercise Price (in dollars per share) | $ 4.91 |
Options Outstanding and Exercisable, Number Exercisable (in shares) | shares | 17,731,361 |
Options Outstanding and Exercisable, Weighted Average Exercise Price (in dollars per share) | $ 4.01 |
$1.46 - $1.90 [Member] | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Exercise Price Range, lower (in dollars per share) | 1.46 |
Exercise Price Range, upper (in dollars per share) | $ 1.90 |
Options Outstanding, Number (in shares) | shares | 8,231,617 |
Options Outstanding, Weighted Average Remaining Contractual Life (in years) | 4 years 7 months 20 days |
Options Outstanding, Weighted Average Exercise Price (in dollars per share) | $ 1.77 |
Options Outstanding and Exercisable, Number Exercisable (in shares) | shares | 8,088,721 |
Options Outstanding and Exercisable, Weighted Average Exercise Price (in dollars per share) | $ 1.77 |
$2.57 - $4.05 [Member] | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Exercise Price Range, lower (in dollars per share) | 2.57 |
Exercise Price Range, upper (in dollars per share) | $ 4.05 |
Options Outstanding, Number (in shares) | shares | 2,707,474 |
Options Outstanding, Weighted Average Remaining Contractual Life (in years) | 5 years 6 months 25 days |
Options Outstanding, Weighted Average Exercise Price (in dollars per share) | $ 3.56 |
Options Outstanding and Exercisable, Number Exercisable (in shares) | shares | 1,130,251 |
Options Outstanding and Exercisable, Weighted Average Exercise Price (in dollars per share) | $ 3.27 |
$4.16 - $5.55 [Member] | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Exercise Price Range, lower (in dollars per share) | 4.16 |
Exercise Price Range, upper (in dollars per share) | $ 5.55 |
Options Outstanding, Number (in shares) | shares | 5,957,725 |
Options Outstanding, Weighted Average Remaining Contractual Life (in years) | 3 years 6 months 29 days |
Options Outstanding, Weighted Average Exercise Price (in dollars per share) | $ 5.18 |
Options Outstanding and Exercisable, Number Exercisable (in shares) | shares | 4,520,554 |
Options Outstanding and Exercisable, Weighted Average Exercise Price (in dollars per share) | $ 5.31 |
$5.61 - $6.21 [Member] | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Exercise Price Range, lower (in dollars per share) | 5.61 |
Exercise Price Range, upper (in dollars per share) | $ 6.21 |
Options Outstanding, Number (in shares) | shares | 4,076,881 |
Options Outstanding, Weighted Average Remaining Contractual Life (in years) | 5 years 2 months 1 day |
Options Outstanding, Weighted Average Exercise Price (in dollars per share) | $ 6.08 |
Options Outstanding and Exercisable, Number Exercisable (in shares) | shares | 1,861,457 |
Options Outstanding and Exercisable, Weighted Average Exercise Price (in dollars per share) | $ 6 |
$6.25 - $18.25 [Member] | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Exercise Price Range, lower (in dollars per share) | 6.25 |
Exercise Price Range, upper (in dollars per share) | $ 18.25 |
Options Outstanding, Number (in shares) | shares | 4,025,968 |
Options Outstanding, Weighted Average Remaining Contractual Life (in years) | 4 years 5 months 1 day |
Options Outstanding, Weighted Average Exercise Price (in dollars per share) | $ 10.67 |
Options Outstanding and Exercisable, Number Exercisable (in shares) | shares | 2,130,378 |
Options Outstanding and Exercisable, Weighted Average Exercise Price (in dollars per share) | $ 8.42 |
Employee Equity and Benefit P76
Employee Equity and Benefit Plans (Summary of All RSU Activity) (Details) - RSUs [Member] $ / shares in Units, $ in Thousands | 12 Months Ended |
Dec. 31, 2016USD ($)$ / sharesshares | |
Shares | |
Awards outstanding at beginning of period (in shares) | shares | 1,002,188 |
Awarded (in shares) | shares | 3,138,236 |
Vested and released (in shares) | shares | (1,640,324) |
Forfeited (in shares) | shares | (30,309) |
Awards outstanding at end of period (in shares) | shares | 2,469,791 |
Weighted Average Grant Date Fair Value | |
Awards outstanding at beginning of period (in dollars per share) | $ / shares | $ 5.16 |
Awarded (in dollars per share) | $ / shares | 7.58 |
Vested and released (in dollars per share) | $ / shares | 4.49 |
Forfeited (in dollars per share) | $ / shares | 4.77 |
Awards outstanding at end of period (in dollars per share) | $ / shares | $ 8.69 |
Weighted Average Remaining Contractual Term, Awards outstanding at December 31, 2016 | 1 year 11 months 4 days |
Aggregate Intrinsic Value, Awards outstanding at December 31, 2016 | $ | $ 36,825 |
Income Taxes (Schedule of Conso
Income Taxes (Schedule of Consolidated Net Income (Loss)) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Income Tax Disclosure [Abstract] | |||
Domestic | $ (70,222) | $ (150,846) | $ (230,535) |
Foreign | 0 | (10,843) | (30,944) |
Loss before income taxes | $ (70,222) | $ (161,689) | $ (261,479) |
Income Taxes (Components of Inc
Income Taxes (Components of Income Tax Expense (Benefit)) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Current: | |||
Federal | $ 0 | $ 0 | $ 0 |
State | 0 | 55 | (182) |
Total current tax expense | 0 | 55 | (182) |
Deferred: | |||
Federal | 0 | 0 | 0 |
State | 0 | 0 | 0 |
Total deferred tax expense | 0 | 0 | 0 |
Income tax (benefit) provision | $ 0 | $ 55 | $ (182) |
Income Taxes (Schedule of Recon
Income Taxes (Schedule of Reconciliation of Income Taxes at the Statutory Federal Income Tax Rate to Net Income Taxes) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Income Tax Disclosure [Abstract] | |||
U.S. federal income tax benefit at statutory rate | $ (23,876) | $ (54,974) | $ (88,903) |
Unutilized net operating losses | 6,377 | 51,421 | 84,985 |
State tax expense | 6,520 | 55 | (182) |
Debt extinguishment | 4,726 | 0 | 0 |
Non-deductible interest | 2,680 | 3,308 | 3,598 |
Stock-based compensation | 3,155 | 195 | 255 |
Other | 418 | 50 | 65 |
Income tax (benefit) provision | $ 0 | $ 55 | $ (182) |
Income Taxes (Schedule of Defer
Income Taxes (Schedule of Deferred Assets and Liabilities) (Details) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Deferred tax assets: | ||
Net operating loss carry-forwards | $ 471,327 | $ 464,504 |
Book over tax depreciation and amortization | 70,617 | 1,752 |
Tax credit and charitable contribution carry-forwards | 64,367 | 64,350 |
Amortization of deferred stock compensation – non-qualified | 14,780 | 14,615 |
Accruals and reserves not currently deductible | 8,117 | 7,775 |
Other | 106 | 0 |
Total deferred tax assets | 629,314 | 552,996 |
Valuation allowance | (629,062) | (536,327) |
Net deferred tax assets | 252 | 16,669 |
Deferred tax liabilities: | ||
Unrealized gain on derivatives | (252) | (497) |
Convertible debt | 0 | (16,172) |
Total deferred tax liabilities | (252) | (16,669) |
Net deferred taxes | $ 0 | $ 0 |
Income Taxes (Narrative) (Detai
Income Taxes (Narrative) (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Income Tax Examination [Line Items] | |||
Valuation allowance increases | $ 92.7 | $ 7.9 | $ 88.8 |
Tax benefit of stock option | 57 | ||
Federal [Member] | |||
Income Tax Examination [Line Items] | |||
Net operating loss carryforwards | 1,424 | ||
Research and development tax credits | 75 | ||
State and Local Jurisdiction [Member] | |||
Income Tax Examination [Line Items] | |||
Net operating loss carryforwards | 494 | ||
State and Local Jurisdiction [Member] | Research Tax Credit Carryforward [Member] | |||
Income Tax Examination [Line Items] | |||
Research and development tax credits | $ 25 |
Income Taxes (Schedule of Unrec
Income Taxes (Schedule of Unrecognized Tax Benefits) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Reconciliation of Unrecognized Tax Benefits, Excluding Amounts Pertaining to Examined Tax Returns [Roll Forward] | |||
Beginning balance | $ 88,638 | $ 58,215 | $ 55,077 |
Decrease (increase) relating to prior year provision | (29,110) | 21,696 | 719 |
Increase relating to current year provision | 2,304 | 8,727 | 2,706 |
Reductions based on the lapse of the applicable statutes of limitations | (23) | 0 | (287) |
Ending balance | $ 61,809 | $ 88,638 | $ 58,215 |
Net Loss Per Share (Details)
Net Loss Per Share (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||||
Dec. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Numerator: | |||||||||||||
Net loss | $ 35,123 | $ (11,284) | $ (34,838) | $ (59,223) | $ (41,568) | $ (45,542) | $ (41,389) | $ (33,245) | $ (70,222) | $ (161,744) | $ (261,297) | $ (238,192) | $ (145,335) |
Denominator: | |||||||||||||
Shares used in computing basic and diluted net loss per share | 250,531 | 209,227 | 194,299 | ||||||||||
Net loss per share, basic and diluted (in dollars per share) | $ 0.12 | $ (0.04) | $ (0.15) | $ (0.26) | $ (0.18) | $ (0.21) | $ (0.21) | $ (0.17) | $ (0.28) | $ (0.77) | $ (1.34) | $ (1.29) | $ (0.91) |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||||||||||||
Total potentially dilutive shares | 62,458 | 117,478 | 105,664 | ||||||||||
Convertible debt [Member] | |||||||||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||||||||||||
Total potentially dilutive shares | 33,890 | 88,008 | 75,734 | ||||||||||
Outstanding stock options, unvested RSUs and ESPP contributions [Member] | |||||||||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||||||||||||
Total potentially dilutive shares | 27,568 | 28,470 | 28,930 | ||||||||||
Warrants [Member] | |||||||||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||||||||||||
Total potentially dilutive shares | 1,000 | 1,000 | 1,000 |
Commitments (Schedule of Aggreg
Commitments (Schedule of Aggregate Future Minimum Lease Payments Under Operating Leases) (Details) $ in Thousands | Dec. 31, 2016USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2,017 | $ 8,474 |
2,018 | 3,007 |
Total | 11,481 |
Future minimum rental under noncancelable subleases | $ 1,200 |
Commitments (Schedule of Aggr85
Commitments (Schedule of Aggregate Future Minimum Lease Payments Under Operating Leases By Material Lease Agreements) (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2016USD ($)renewal | |
Operating Leased Assets [Line Items] | |
Future Minimum Lease Payments | $ 11,481 |
Building Lease #1&2 [Member] | |
Operating Leased Assets [Line Items] | |
Number of Renewal Options | renewal | 0 |
Future Minimum Lease Payments | $ 3,425 |
Building Lease #3 [Member] | |
Operating Leased Assets [Line Items] | |
Number of Renewal Options | renewal | 1 |
Period of Renewal Options | 5 years |
Future Minimum Lease Payments | $ 8,056 |
Commitments (Narrative) (Detail
Commitments (Narrative) (Details) | 1 Months Ended | 12 Months Ended | ||
May 31, 2007debt_instrument | Dec. 31, 2016USD ($)debt_instrument | Dec. 31, 2015USD ($) | Dec. 31, 2014USD ($) | |
Commitments and Contingencies Disclosure [Abstract] | ||||
Rent expenses under operating leases | $ 6,100,000 | $ 8,700,000 | $ 10,300,000 | |
Net of sublease rentals under operating leases | $ 3,600,000 | 5,200,000 | $ 4,900,000 | |
Operating Leased Assets [Line Items] | ||||
Number of letters of credit entered into (in debt instruments) | debt_instrument | 2 | 3 | ||
Collateral provided for purchasing card program | $ 3,000,000 | 1,500,000 | ||
Building Lease [Member] | ||||
Operating Leased Assets [Line Items] | ||||
Standby letter of credit, amount | 500,000 | 500,000 | ||
Workers Compensation Insurance Policy [Member] | ||||
Operating Leased Assets [Line Items] | ||||
Standby letter of credit, amount | $ 600,000 | $ 600,000 |
Concentrations of Credit Risk87
Concentrations of Credit Risk (Narrative) (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Concentration Risk [Line Items] | |||
Foreign exchange fluctuations gain (loss) | $ (0.2) | $ 0.1 | $ 0.5 |
Customer Concentration Risk [Member] | Accounts Receivable [Member] | Diplomat Specialty Pharmacy [Member] | |||
Concentration Risk [Line Items] | |||
Concentration risk ( as a percentage) | 27.00% | ||
Customer Concentration Risk [Member] | Accounts Receivable [Member] | Caremark L.L.C. [Member] | |||
Concentration Risk [Line Items] | |||
Concentration risk ( as a percentage) | 19.00% | ||
Customer Concentration Risk [Member] | Accounts Receivable [Member] | Affiliates of McKessen Corporation [Member] | |||
Concentration Risk [Line Items] | |||
Concentration risk ( as a percentage) | 16.00% | ||
Customer Concentration Risk [Member] | Accounts Receivable [Member] | Accredo Health, Incorporated [Member] | |||
Concentration Risk [Line Items] | |||
Concentration risk ( as a percentage) | 13.00% | ||
Customer Concentration Risk [Member] | Collaboration Agreement [Member] | Ipsen [Member] | |||
Concentration Risk [Line Items] | |||
Receivable | $ 10 |
Concentrations of Credit Risk88
Concentrations of Credit Risk (Revenues by Customer) (Details) - Customer Concentration Risk [Member] - Revenues [Member] | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Diplomat Specialty Pharmacy [Member] | |||
Concentration Risk [Line Items] | |||
Concentration risk ( as a percentage) | 33.00% | 83.00% | 99.00% |
Ipsen [Member] | |||
Concentration Risk [Line Items] | |||
Concentration risk ( as a percentage) | 17.00% | 0.00% | 0.00% |
Concentrations of Credit Risk89
Concentrations of Credit Risk (Revenues by Geographic Region) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Concentration Risk [Line Items] | |||
Collaboration revenues | $ 56,079 | $ 3,014 | $ 0 |
Geographic Concentration Risk [Member] | Revenues [Member] | U.S. [Member] | |||
Concentration Risk [Line Items] | |||
Collaboration revenues | 140,709 | 33,869 | 24,832 |
Geographic Concentration Risk [Member] | Revenues [Member] | Europe [Member] | |||
Concentration Risk [Line Items] | |||
Collaboration revenues | 35,745 | 3,303 | 279 |
Geographic Concentration Risk [Member] | Revenues [Member] | Rest of World [Member] | |||
Concentration Risk [Line Items] | |||
Collaboration revenues | $ 15,000 | $ 0 | $ 0 |
Subsequent Event (Details)
Subsequent Event (Details) - Subsequent Event [Member] - Collaborative Arrangement with Takeda [Member] | 1 Months Ended |
Feb. 28, 2017USD ($) | |
Subsequent Event [Line Items] | |
Upfront payment | $ 50,000,000 |
Maximum amount eligible for development and regulatory milestones | 95,000,000 |
Maximum pre-specified payments | $ 83,000,000 |
Collaboration period to achieve specified levels of commercial performance | 6 years |
Minimum [Member] | |
Subsequent Event [Line Items] | |
Royalty rate (as a percent) | 20.00% |
Maximum [Member] | |
Subsequent Event [Line Items] | |
Royalty rate (as a percent) | 30.00% |
Cabozantinib [Member] | Takeda [Member] | |
Subsequent Event [Line Items] | |
Costs associated with development of product shouldered by collaboration partner (as a percent) | 20.00% |
Cabozantinib [Member] | Japan [Member] | |
Subsequent Event [Line Items] | |
Cumulative net sales | $ 300,000,000 |
Cabozantinib [Member] | Japan [Member] | Takeda [Member] | |
Subsequent Event [Line Items] | |
Costs associated with development of product shouldered by collaboration partner (as a percent) | 100.00% |
Cabozantinib [Member] | Japan [Member] | Minimum [Member] | |
Subsequent Event [Line Items] | |
Royalty rate (as a percent) | 15.00% |
Cabozantinib [Member] | Japan [Member] | Maximum [Member] | |
Subsequent Event [Line Items] | |
Royalty rate (as a percent) | 24.00% |
Quarterly Financial Data (Una91
Quarterly Financial Data (Unaudited) (Summary of Unaudited Quarterly Financial Data) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||||
Dec. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Quarterly Financial Information Disclosure [Abstract] | |||||||||||||
Revenues | $ 77,581 | $ 62,194 | $ 36,252 | $ 15,427 | $ 9,938 | $ 9,854 | $ 7,992 | $ 9,388 | $ 191,454 | $ 37,172 | $ 25,111 | ||
Gross profit | 50,064 | 40,287 | 30,058 | 8,414 | 8,915 | 8,434 | 7,306 | 8,622 | |||||
Income (loss) from operations | 38,883 | 7,264 | (25,136) | (49,135) | (31,600) | (35,781) | (31,280) | (22,760) | (28,124) | (121,421) | (224,458) | ||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | |||||||||||||
Net income (loss) | $ 35,123 | $ (11,284) | $ (34,838) | $ (59,223) | $ (41,568) | $ (45,542) | $ (41,389) | $ (33,245) | $ (70,222) | $ (161,744) | $ (261,297) | $ (238,192) | $ (145,335) |
Net loss per share, basic and diluted (in dollars per share) | $ 0.12 | $ (0.04) | $ (0.15) | $ (0.26) | $ (0.18) | $ (0.21) | $ (0.21) | $ (0.17) | $ (0.28) | $ (0.77) | $ (1.34) | $ (1.29) | $ (0.91) |
Restatement Adjustment [Member] | |||||||||||||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | |||||||||||||
Net income (loss) | $ 2,200 | $ 2,100 | $ 2,100 | $ 2,000 | $ 2,000 | $ 1,900 | |||||||
Net loss per share, basic and diluted (in dollars per share) | $ 0.01 | $ 0.01 | $ 0.01 | $ 0.01 | $ 0.01 | $ 0.01 |
Quarterly Financial Data (Una92
Quarterly Financial Data (Unaudited) (Narrative) (Details) | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||||
Dec. 31, 2016USD ($) | Nov. 30, 2016USD ($) | Dec. 31, 2016USD ($)milestone | Sep. 30, 2016USD ($) | Mar. 31, 2016USD ($) | Dec. 31, 2016USD ($) | Dec. 31, 2015USD ($) | Dec. 31, 2014USD ($) | |
Collaborative Arrangement with Ipsen, Upfront Payment [Member] | ||||||||
Deferred Revenue Arrangement [Line Items] | ||||||||
Amortization of deferred revenue | $ 200,000,000 | |||||||
Collaborative Arrangement with Ipsen, Approval of Product by EC in Second-Line RCC [Member] | CABOMETYX [Member] | ||||||||
Deferred Revenue Arrangement [Line Items] | ||||||||
Revenue recognized, milestones | $ 60,000,000 | |||||||
Collaborative Arrangement with Ipsen, Approval of Product by EC in Second-Line RCC [Member] | CABOMETYX [Member] | Germany [Member] | ||||||||
Deferred Revenue Arrangement [Line Items] | ||||||||
Revenue recognized, milestones | 60,000,000 | |||||||
Collaborative Arrangement with Ipsen, Consideration for Commercialization Rights [Member] | Canada [Member] | ||||||||
Deferred Revenue Arrangement [Line Items] | ||||||||
Revenue recognized, milestones | $ 10,000,000 | |||||||
Collaborative Arrangement with Ipsen, First Commercial Sales of Product [Member] | CABOMETYX [Member] | ||||||||
Deferred Revenue Arrangement [Line Items] | ||||||||
Number of milestones achieved | milestone | 2 | |||||||
Collaborative Arrangement with Ipsen, First Commercial Sales of Product [Member] | CABOMETYX [Member] | Germany [Member] | ||||||||
Deferred Revenue Arrangement [Line Items] | ||||||||
Revenue recognized, milestones | $ 10,000,000 | |||||||
Collaborative Arrangement with Ipsen, First Commercial Sales of Product [Member] | CABOMETYX [Member] | United Kingdom [Member] | ||||||||
Deferred Revenue Arrangement [Line Items] | ||||||||
Revenue recognized, milestones | 10,000,000 | |||||||
Collaborative Arrangement with Daiichi Sankyo [Member] | ||||||||
Deferred Revenue Arrangement [Line Items] | ||||||||
Revenue recognized, milestones | $ 15,000,000 | 15,000,000 | $ 0 | $ 0 | ||||
Collaboration Agreement with Merck [Member] | ||||||||
Deferred Revenue Arrangement [Line Items] | ||||||||
Revenue recognized, milestones | $ 5,000,000 | $ 5,000,000 | $ 3,000,000 | $ 0 | ||||
Collaborative Arrangement with Genentech [Member] | ||||||||
Deferred Revenue Arrangement [Line Items] | ||||||||
Recovery of expenses with interest from losses recorded in prior period | 23,100,000 | |||||||
Recovery of expenses, expenses prior to current fiscal year | $ 13,300,000 |