FORM 10-Q |
ý | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
¨ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to |
EXELIXIS, INC. (Exact name of registrant as specified in its charter) |
Delaware | 04-3257395 |
(State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification Number) |
Large accelerated filer | ý | Accelerated filer | ¨ | |||
Non-accelerated filer | ¨ (Do not check if a smaller reporting company) | Smaller reporting company | ¨ |
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September 30, 2016 | December 31, 2015* | ||||||
(unaudited) | |||||||
ASSETS | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 111,219 | $ | 141,634 | |||
Short-term investments | 208,462 | 25,426 | |||||
Trade and other receivables | 91,207 | 5,183 | |||||
Inventory | 3,292 | 2,616 | |||||
Prepaid expenses and other current assets | 7,148 | 3,806 | |||||
Total current assets | 421,328 | 178,665 | |||||
Long-term investments | 55,817 | 83,600 | |||||
Long-term restricted cash and investments | 4,150 | 2,650 | |||||
Property and equipment, net | 1,737 | 1,434 | |||||
Goodwill | 63,684 | 63,684 | |||||
Other long-term assets | 1,774 | 2,309 | |||||
Total assets | $ | 548,490 | $ | 332,342 | |||
LIABILITIES AND STOCKHOLDERS’ DEFICIT | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 3,965 | $ | 6,401 | |||
Accrued collaboration liability | 18,710 | 10,938 | |||||
Accrued compensation and benefits | 15,986 | 3,629 | |||||
Accrued clinical trial liabilities | 14,887 | 18,071 | |||||
Current portion of convertible notes | 29,365 | — | |||||
Current portion of term loan payable | 80,000 | — | |||||
Current portion of deferred revenue | 18,939 | — | |||||
Other accrued liabilities | 19,791 | 13,212 | |||||
Total current liabilities | 201,643 | 52,251 | |||||
Long-term portion of convertible notes | 81,493 | 337,937 | |||||
Long-term portion of term loan payable | — | 80,000 | |||||
Long-term portion of deferred revenue | 232,573 | — | |||||
Other long-term liabilities | 759 | 2,960 | |||||
Total liabilities | 516,468 | 473,148 | |||||
Commitments | |||||||
Stockholders’ equity (deficit): | |||||||
Preferred stock | — | — | |||||
Common stock, $0.001 par value; 400,000,000 shares authorized; issued and outstanding: 286,123,166 and 227,960,943 shares at September 30, 2016 and December 31, 2015, respectively | 286 | 228 | |||||
Additional paid-in capital | 2,050,086 | 1,772,123 | |||||
Accumulated other comprehensive loss | (80 | ) | (232 | ) | |||
Accumulated deficit | (2,018,270 | ) | (1,912,925 | ) | |||
Total stockholders’ equity (deficit) | 32,022 | (140,806 | ) | ||||
Total liabilities and stockholders’ equity (deficit) | $ | 548,490 | $ | 332,342 |
* | The condensed consolidated balance sheet as of December 31, 2015 has been derived from the audited financial statements as of that date. |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||||||
Revenues: | |||||||||||||||
Net product revenues | $ | 42,742 | $ | 6,854 | $ | 83,459 | $ | 24,234 | |||||||
Royalty, license and contract revenues | 19,452 | 3,000 | 30,414 | 3,000 | |||||||||||
Total revenues | 62,194 | 9,854 | 113,873 | 27,234 | |||||||||||
Operating expenses: | |||||||||||||||
Cost of goods sold | 2,455 | 1,420 | 4,700 | 2,872 | |||||||||||
Research and development | 20,256 | 26,091 | 72,166 | 72,879 | |||||||||||
Selling, general and administrative | 32,463 | 17,842 | 103,143 | 40,162 | |||||||||||
Restructuring (recovery) charge | (244 | ) | 282 | 871 | 1,142 | ||||||||||
Total operating expenses | 54,930 | 45,635 | 180,880 | 117,055 | |||||||||||
Income (loss) from operations | 7,264 | (35,781 | ) | (67,007 | ) | (89,821 | ) | ||||||||
Other income (expense), net: | |||||||||||||||
Interest income and other, net | 3,059 | 276 | 4,010 | 146 | |||||||||||
Interest expense | (7,834 | ) | (10,037 | ) | (28,575 | ) | (30,501 | ) | |||||||
Loss on extinguishment of debt | (13,773 | ) | — | (13,773 | ) | — | |||||||||
Total other income (expense), net | (18,548 | ) | (9,761 | ) | (38,338 | ) | (30,355 | ) | |||||||
Net loss | $ | (11,284 | ) | $ | (45,542 | ) | $ | (105,345 | ) | $ | (120,176 | ) | |||
Net loss per share, basic and diluted | $ | (0.04 | ) | $ | (0.21 | ) | $ | (0.44 | ) | $ | (0.59 | ) | |||
Shares used in computing basic and diluted net loss per share | 256,319 | 217,587 | 238,024 | 203,153 |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||||||
Net loss | $ | (11,284 | ) | $ | (45,542 | ) | $ | (105,345 | ) | $ | (120,176 | ) | |||
Other comprehensive income (loss) (1) | (209 | ) | 133 | 152 | 80 | ||||||||||
Comprehensive loss | $ | (11,493 | ) | $ | (45,409 | ) | $ | (105,193 | ) | $ | (120,096 | ) |
(1) | Other comprehensive income (loss) consisted solely of unrealized gains or losses, net on available for sale securities arising during the periods presented. There were no reclassification adjustments to net loss resulting from realized gains or losses on the sale of securities and there was no income tax expense related to other comprehensive income during those periods. |
Nine Months Ended September 30, | |||||||
2016 | 2015 | ||||||
Cash flows from operating activities: | |||||||
Net loss | $ | (105,345 | ) | $ | (120,176 | ) | |
Adjustments to reconcile net loss to net cash provided by (used in) operating activities: | |||||||
Depreciation and amortization | 754 | 1,063 | |||||
Stock-based compensation expense | 18,346 | 15,420 | |||||
Accretion of debt discount and debt issuance costs | 8,295 | 14,274 | |||||
Accrual of interest paid in kind | 5,939 | 1,890 | |||||
Gain on sale of equity investment | (2,494 | ) | (95 | ) | |||
Loss on extinguishment of debt | 13,773 | — | |||||
Change in the fair value of warrants | — | 549 | |||||
Other | (1,381 | ) | 1,338 | ||||
Changes in assets and liabilities: | |||||||
Trade and other receivables | (85,923 | ) | 1,034 | ||||
Inventory | (676 | ) | 259 | ||||
Prepaid expenses and other current assets | (3,342 | ) | (1,940 | ) | |||
Other long term assets | 535 | 1,832 | |||||
Accounts payable, accrued compensation and benefits, and other accrued liabilities | 18,816 | (14,293 | ) | ||||
Accrued collaboration liability | 7,772 | 8,400 | |||||
Clinical trial liabilities | (3,184 | ) | (11,757 | ) | |||
Deferred revenue | 251,512 | (2,583 | ) | ||||
Other long-term liabilities | (815 | ) | (1,367 | ) | |||
Net cash provided by (used in) operating activities | 122,582 | (106,152 | ) | ||||
Cash flows from investing activities: | |||||||
Purchases of property and equipment | (1,116 | ) | (114 | ) | |||
Proceeds from sale of property and equipment | 92 | 1,300 | |||||
Proceeds from sale of equity investments | 2,494 | 95 | |||||
Proceeds from maturities of restricted cash and investments | 2,650 | 16,754 | |||||
Purchase of restricted cash and investments | (4,150 | ) | (2,616 | ) | |||
Proceeds from sale of investments | 2,266 | — | |||||
Proceeds from maturities of investments | 100,635 | 130,341 | |||||
Purchases of investments | (258,509 | ) | (119,692 | ) | |||
Net cash (used in) provided by investing activities | (155,638 | ) | 26,068 | ||||
Cash flows from financing activities: | |||||||
Proceeds from issuance of common stock, net | — | 145,651 | |||||
Proceeds from exercise of stock options | 9,296 | 3,787 | |||||
Proceeds from employee stock purchase plan | 479 | 274 | |||||
Principal payments on debt | — | (4,381 | ) | ||||
Payments on conversion of convertible notes | (7,134 | ) | — | ||||
Net cash provided by financing activities | 2,641 | 145,331 | |||||
Net (decrease) increase in cash and cash equivalents | (30,415 | ) | 65,247 | ||||
Cash and cash equivalents at beginning of period | 141,634 | 80,395 | |||||
Cash and cash equivalents at end of period | $ | 111,219 | $ | 145,642 | |||
Supplemental cash flow disclosure - non-cash financing activity: | |||||||
Issuance of common stock in settlement of convertible notes | $ | 285,308 | $ | — |
Three months ended September 30, 2015 | Nine months ended September 30, 2015 | Year ended December 31, | |||||||||||||||||||||
2015 | 2014 | 2013 | 2012 | ||||||||||||||||||||
Statements of Operations: | |||||||||||||||||||||||
Interest expense, overstated by $2,022, $5,920, $7,993, $7,245, $6,568, $2,310 for the three and nine months ended September 30, 2015 and the years ended December 31, 2015, 2014, 2013 and 2012, respectively | $ | (10,037 | ) | $ | (30,501 | ) | $ | (40,680 | ) | $ | (41,362 | ) | $ | (38,779 | ) | $ | (24,778 | ) | |||||
Total other income (expense), net, overstated by $2,022, $5,920, $7,993, $7,245, $6,568, $2,310 for the three and nine months ended September 30, 2015 and the years ended December 31, 2015, 2014, 2013 and 2012, respectively | $ | (9,761 | ) | $ | (30,355 | ) | $ | (40,268 | ) | $ | (37,021 | ) | $ | (37,556 | ) | $ | (22,792 | ) | |||||
Net loss, overstated by $2,022, $5,920, $7,993, $7,245, $6,568, $2,310 for the three and nine months ended September 30, 2015 and the years ended December 31, 2015, 2014, 2013 and 2012, respectively | $ | (45,542 | ) | $ | (120,176 | ) | $ | (161,744 | ) | $ | (261,297 | ) | $ | (238,192 | ) | $ | (145,335 | ) | |||||
Net loss per share, basic and diluted, overstated by $0.01, $0.03, $0.04, $0.04, $0.04, $0.01 for the three and nine months ended September 30, 2015 and the years ended December 31, 2015, 2014, 2013 and 2012, respectively | $ | (0.21 | ) | $ | (0.59 | ) | $ | (0.77 | ) | $ | (1.34 | ) | $ | (1.29 | ) | $ | (0.91 | ) | |||||
Statements of Comprehensive Loss: | |||||||||||||||||||||||
Comprehensive loss, overstated by $2,022, $5,920, $7,993, $7,245, $6,568, $2,310 for the three and nine months ended September 30, 2015 and the years ended December 31, 2015, 2014, 2013 and 2012, respectively | $ | (45,409 | ) | $ | (120,096 | ) | $ | (161,855 | ) | $ | (261,564 | ) | $ | (237,954 | ) | $ | (145,289 | ) | |||||
Statements of Cash Flows(1): | |||||||||||||||||||||||
Net loss, overstated by $5,920, $7,993, $7,245, $6,568, $2,310 for the nine months ended September 30, 2015 and the years ended December 31, 2015, 2014, 2013 and 2012, respectively | Not reported | $ | (120,176 | ) | $ | (161,744 | ) | $ | (261,297 | ) | $ | (238,192 | ) | $ | (145,335 | ) | |||||||
Accretion of debt discount and debt issuance costs, overstated by $5,920, $7,993, $7,245, $6,568, $2,310 for the nine months ended September 30, 2015 and the years ended December 31, 2015, 2014, 2013 and 2012, respectively | Not reported | $ | 14,274 | $ | 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. |
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 | ) | $ | (1,751,180 | ) | $ | (1,489,883 | ) | $ | (1,251,692 | ) | |||
Stockholders’ (deficit) equity, misstated by $36,502, $44,494, $51,739, $58,307 as of December 31, 2015, 2014, 2013 and 2012, respectively | $ | (140,806 | ) | $ | (159,323 | ) | $ | 14,499 | $ | 238,127 | |||||
Statements of Stockholders’ (Deficit) Equity: | |||||||||||||||
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 | ) | $ | (1,751,180 | ) | $ | (1,489,883 | ) | $ | (1,251,692 | ) | |||
Stockholders’ (deficit) equity, misstated by $36,502, $44,494, $51,739, $58,307 as of December 31, 2015, 2014, 2013 and 2012, respectively | $ | (140,806 | ) | $ | (159,323 | ) | $ | 14,499 | $ | 238,127 |
2010 Restructurings | 2014 Restructuring | Total | |||||||||
Restructuring liability as of December 31, 2015 | $ | 4,087 | $ | 503 | $ | 4,590 | |||||
Restructuring charge | 862 | 9 | 871 | ||||||||
Proceeds from sale of assets | — | 34 | 34 | ||||||||
Cash payments, net | (3,774 | ) | (437 | ) | (4,211 | ) | |||||
Other items | 975 | (34 | ) | 941 | |||||||
Restructuring liability as of September 30, 2016 | $ | 2,150 | $ | 75 | $ | 2,225 |
September 30, 2016 | |||||||||||||||
Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Fair Value | ||||||||||||
Cash and cash equivalents | $ | 111,219 | $ | — | $ | — | $ | 111,219 | |||||||
Short-term investments | 208,412 | 70 | (20 | ) | 208,462 | ||||||||||
Long-term investments | 55,840 | 28 | (51 | ) | 55,817 | ||||||||||
Long-term restricted cash and investments | 4,150 | — | — | 4,150 | |||||||||||
Total cash and investments | $ | 379,621 | $ | 98 | $ | (71 | ) | $ | 379,648 |
December 31, 2015 | |||||||||||||||
Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Fair Value | ||||||||||||
Cash and cash equivalents | $ | 141,634 | $ | — | $ | — | $ | 141,634 | |||||||
Short-term investments | 25,484 | 5 | (63 | ) | 25,426 | ||||||||||
Long-term investments | 83,665 | 2 | (67 | ) | 83,600 | ||||||||||
Long-term restricted cash and investments | 2,650 | — | — | 2,650 | |||||||||||
Total cash and investments | $ | 253,433 | $ | 7 | $ | (130 | ) | $ | 253,310 |
September 30, 2016 | |||||||||||||||
Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Fair Value | ||||||||||||
Money market funds | $ | 47,148 | $ | — | $ | — | $ | 47,148 | |||||||
Commercial paper | 133,309 | — | — | 133,309 | |||||||||||
Corporate bonds | 124,346 | 44 | (67 | ) | 124,323 | ||||||||||
U.S. Treasury and government sponsored enterprises | 61,228 | 54 | (4 | ) | 61,278 | ||||||||||
Total investments | $ | 366,031 | $ | 98 | $ | (71 | ) | $ | 366,058 |
December 31, 2015 | |||||||||||||||
Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Fair Value | ||||||||||||
Money market funds | $ | 72,000 | $ | — | $ | — | $ | 72,000 | |||||||
Commercial paper | 78,155 | — | — | 78,155 | |||||||||||
Corporate bonds | 72,205 | 4 | (118 | ) | 72,091 | ||||||||||
U.S. Treasury and government sponsored enterprises | 28,434 | 1 | (12 | ) | 28,423 | ||||||||||
Marketable equity security | 16 | 2 | — | 18 | |||||||||||
Total investments | $ | 250,810 | $ | 7 | $ | (130 | ) | $ | 250,687 |
Mature within One Year | After One Year through Two Years | Fair Value | |||||||||
Money market funds | $ | 47,148 | $ | — | $ | 47,148 | |||||
Commercial paper | 133,309 | — | 133,309 | ||||||||
Corporate bonds | 74,661 | 49,662 | 124,323 | ||||||||
U.S. Treasury and government sponsored enterprises | 55,123 | 6,155 | 61,278 | ||||||||
Total investments | $ | 310,241 | $ | 55,817 | $ | 366,058 |
September 30, 2016 | December 31, 2015 | ||||||
Raw materials | $ | 890 | $ | 1,037 | |||
Work in process | 2,540 | 2,251 | |||||
Finished goods | 582 | 583 | |||||
Total | 4,012 | 3,871 | |||||
Less: non-current portion included in Other assets | (720 | ) | (1,255 | ) | |||
Inventory | $ | 3,292 | $ | 2,616 |
September 30, 2016 | December 31, 2015 | ||||||
Convertible Senior Subordinated Notes due 2019 (“2019 Notes”) | $ | 1,865 | $ | 235,210 | |||
Secured Convertible Notes due 2018 (“Deerfield Notes”) | 108,993 | 102,727 | |||||
Term loan payable | 80,000 | 80,000 | |||||
Total debt | 190,858 | 417,937 | |||||
Less: current portion | (109,365 | ) | — | ||||
Long-term debt | $ | 81,493 | $ | 417,937 |
September 30, 2016 | December 31, 2015 | ||||||
Net carrying amount of the liability component | $ | 1,865 | $ | 235,210 | |||
Unamortized discount of the liability component | 327 | 52,290 | |||||
Face amount of the 2019 Notes | $ | 2,192 | $ | 287,500 |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||||||
Stated coupon interest | $ | 1,683 | $ | 3,054 | $ | 7,793 | $ | 9,164 | |||||||
Amortization of debt discount and debt issuance costs | 1,763 | 2,929 | 7,968 | 8,585 | |||||||||||
Total interest expense | $ | 3,446 | $ | 5,983 | $ | 15,761 | $ | 17,749 |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||||||
Stated coupon interest paid in cash | $ | 2,031 | $ | 1,891 | $ | 5,939 | $ | 4,866 | |||||||
Amortization of debt discount, debt issuance costs and accrual of interest paid in kind | 2,152 | 1,959 | 6,266 | 7,279 | |||||||||||
Total interest expense | $ | 4,183 | $ | 3,850 | $ | 12,205 | $ | 12,145 |
September 30, 2016 | |||||||||||
Level 1 | Level 2 | Total | |||||||||
Money market funds | $ | 47,148 | $ | — | $ | 47,148 | |||||
Commercial paper | — | 133,309 | 133,309 | ||||||||
Corporate bonds | — | 124,323 | 124,323 | ||||||||
U.S. Treasury and government sponsored enterprises | — | 61,278 | 61,278 | ||||||||
Total financial assets | $ | 47,148 | $ | 318,910 | $ | 366,058 |
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 |
September 30, 2016 | December 31, 2015 | ||||||||||||||
Carrying Amount | Fair Value | Carrying Amount | Fair Value | ||||||||||||
2019 Notes | $ | 1,865 | $ | 5,277 | $ | 235,210 | $ | 336,260 | |||||||
Deerfield Notes | $ | 108,993 | $ | 110,806 | $ | 102,727 | $ | 101,096 | |||||||
Term loan payable | $ | 80,000 | $ | 79,828 | $ | 80,000 | $ | 79,815 |
• | 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. |
• | On August 24, 2016, we announced the redemption of $48.1 million of the 2019 Notes, representing all remaining 2019 Notes outstanding. As of September 30, 2016, the 2019 Notes were convertible 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 2019 Notes at any time before close of business on October 31, 2016. Following our issuance of the notice of redemption of the 2019 Notes, the third-party pricing source we historically used to value the 2019 Notes was no longer available. Based on the terms of the redemption and the related conversion feature, we estimated that the value of the shares issuable pursuant to a conversion by the holder approximates the fair value of the 2019 Notes, which represents a Level 3 input. |
• | We estimate the fair value of our other debt instruments, where possible, using the net present value of the payments. For the term loan, we use an interest rate that is consistent with money-market rates that would have been earned on our non-interest-bearing compensating balances as our discount rate, which is a Level 2 input. For the Deerfield Notes, we used a discount rate of 15%, which we estimate as our current borrowing rate for similar debt as of September 30, 2016, which is a Level 3 input. |
• | 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 9.50%, which we estimate as our current borrowing rate for straight debt as of September 30, 2016, which is a Level 3 input. |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||||||
Research and development expense | $ | 1,165 | $ | 6,676 | $ | 7,894 | $ | 8,049 | |||||||
Selling, general and administrative expense | 2,438 | 5,350 | 10,452 | 7,371 | |||||||||||
Total employee stock-based compensation expense | $ | 3,603 | $ | 12,026 | $ | 18,346 | $ | 15,420 |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||||||
Stock options | $ | 8.59 | $ | 3.92 | $ | 4.31 | $ | 2.51 | |||||||
ESPP | $ | 1.51 | $ | 1.26 | $ | 1.65 | $ | 0.97 |
Stock Options | |||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||
Risk-free interest rate | 1.07 | % | 1.18 | % | 1.09 | % | 1.20 | % | |||
Dividend yield | — | % | — | % | — | % | — | % | |||
Volatility | 76 | % | 88 | % | 76 | % | 93 | % | |||
Expected life | 4.5 years | 4.6 years | 4.4 years | 4.5 years |
Employee Stock Purchase Plan | |||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||
Risk-free interest rate | 0.37 | % | 0.06 | % | 0.39 | % | 0.09 | % | |||
Dividend yield | — | % | — | % | — | % | — | % | |||
Volatility | 63 | % | 107 | % | 66 | % | 101 | % | |||
Expected life | 6 months | 6 months | 6 months | 6 months |
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 | 3,771,250 | $ | 7.35 | |||||||||
Exercised | (3,360,248 | ) | $ | 2.81 | ||||||||
Forfeited | (307,601 | ) | $ | 4.67 | ||||||||
Expired | (80,516 | ) | $ | 10.49 | ||||||||
Options outstanding at September 30, 2016 | 27,448,739 | $ | 4.80 | 4.58 years | $ | 221,332 | ||||||
Exercisable at September 30, 2016 | 20,042,258 | $ | 4.19 | 4.02 years | $ | 172,458 |
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 | 3,038,386 | $ | 7.38 | |||||||||
Vested and released | (1,390,654 | ) | $ | 5.55 | ||||||||
Forfeited | (30,309 | ) | $ | 4.77 | ||||||||
Awards outstanding at September 30, 2016 | 2,619,611 | $ | 8.21 | 1.97 years | $ | 33,505 |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||||||
Numerator: | |||||||||||||||
Net loss | $ | (11,284 | ) | $ | (45,542 | ) | $ | (105,345 | ) | $ | (120,176 | ) | |||
Denominator: | |||||||||||||||
Shares used in computing basic and diluted net loss per share | 256,319 | 217,587 | 238,024 | 203,153 | |||||||||||
Net loss per share, basic and diluted | $ | (0.04 | ) | $ | (0.21 | ) | $ | (0.44 | ) | $ | (0.59 | ) |
September 30 | |||||
2016 | 2015 | ||||
Convertible Senior Subordinated Notes due 2019 | 413 | 54,118 | |||
Secured Convertible Notes due 2018 | 33,890 | 33,890 | |||
Outstanding stock options, unvested RSUs and ESPP contributions | 30,474 | 31,331 | |||
Warrants | 1,000 | 1,000 | |||
Total potentially dilutive shares | 65,777 | 120,339 |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||
Percentage of revenues earned in the United States | 98 | % | 96 | % | 98 | % | 90 | % | |||
Percentage of revenues earned in Europe | 2 | % | 4 | % | 2 | % | 10 | % |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||
Product sales: | |||||||||||
Diplomat Specialty Pharmacy | 31 | % | 66 | % | 41 | % | 79 | % | |||
Sobi | 2 | % | 4 | % | 2 | % | 10 | % | |||
Collaboration agreements: | |||||||||||
Merck | — | % | 30 | % | 4 | % | 11 | % | |||
Daiichi Sankyo | 24 | % | — | % | 13 | % | — | % |
• | COTEZO, a phase 3 pivotal trial evaluating the combination of cobimetinib and atezolizumab, an anti-PD-L1 antibody, or atezolizumab alone versus regorafenib, in unresectable locally advanced or metastatic colorectal cancer, or CRC. COTEZO is expected to enroll 360 patients who have received at least two prior chemotherapies in the metastatic disease setting, and the primary endpoint of the trial is OS. The decision to start COTEZO was informed by results from the ongoing phase 1b trial of the combination in advanced solid tumors; |
• | The combination of cobimetinib and vemuarfenib in additional melanoma patient populations and settings; |
• | A phase 2 trial of cobimetinib in combination with paclitaxel in triple negative breast cancer; |
• | Phase 1 studies of cobimetinib in combination with atezolizumab in melanoma and non-small cell lung cancer, or NSCLC, in combination with vemurafenib and atezolizumab in melanoma, and in combination with venetoclax in relapsed or refractory acute myeloid leukemia; and |
• | A phase 1b study evaluating the safety, tolerability and pharmacokinetics of cobimetinib in combination with atezolizumab and bevacizumab in patients with metastatic colorectal cancer. |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||||||
Stated coupon interest | $ | 2,031 | $ | 1,891 | $ | 5,939 | $ | 4,866 | |||||||
Amortization of debt discount, debt issuance costs and accrual of interest paid in kind | 2,152 | 1,959 | 6,266 | 7,279 | |||||||||||
Total interest expense | $ | 4,183 | $ | 3,850 | $ | 12,205 | $ | 12,145 |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||||||
Gross product revenues | $ | 46,720 | $ | 7,230 | $ | 92,383 | $ | 25,794 | |||||||
Discounts and allowances | (3,978 | ) | (376 | ) | (8,924 | ) | (1,560 | ) | |||||||
Net product revenues | 42,742 | 6,854 | 83,459 | 24,234 | |||||||||||
Royalty and license revenues (1) | 4,452 | — | 10,414 | — | |||||||||||
Contract revenues (2) | 15,000 | 3,000 | 20,000 | 3,000 | |||||||||||
Total revenues | $ | 62,194 | $ | 9,854 | $ | 113,873 | $ | 27,234 | |||||||
Dollar change | $ | 52,340 | $ | 86,639 | |||||||||||
Percentage change | 531 | % | 318 | % |
(1) | Includes royalties and amortization of upfront payments. |
(2) | Includes contingent and milestone payments. |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||||||
CABOMETYX | $ | 31,238 | $ | — | $ | 48,812 | $ | — | |||||||
COMETRIQ | 11,504 | 6,854 | 34,647 | 24,234 | |||||||||||
Net product revenues | $ | 42,742 | $ | 6,854 | $ | 83,459 | $ | 24,234 | |||||||
Dollar change | $ | 35,888 | $ | 59,225 | |||||||||||
Percentage change | 524 | % | 244 | % |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||||||
Diplomat Specialty Pharmacy | $ | 19,392 | $ | 6,457 | $ | 46,770 | $ | 21,567 | |||||||
Daiichi Sankyo | 15,000 | — | 15,000 | — | |||||||||||
Merck | — | 3,000 | 5,000 | 3,000 | |||||||||||
Swedish Orphan Biovitrum | 1,350 | 397 | 2,453 | 2,667 | |||||||||||
Others, individually less than 10% of total revenues for all periods presented | 26,452 | — | 44,650 | — | |||||||||||
Total revenues | $ | 62,194 | $ | 9,854 | $ | 113,873 | $ | 27,234 | |||||||
Dollar change | $ | 52,340 | $ | 86,639 | |||||||||||
Percentage change | 531 | % | 318 | % |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||||||
Cost of goods sold | $ | 2,455 | $ | 1,420 | $ | 4,700 | $ | 2,872 | |||||||
Gross margin | 94 | % | 79 | % | 94 | % | 88 | % |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||||||
Research and development expenses | $ | 20,256 | $ | 26,091 | $ | 72,166 | $ | 72,879 | |||||||
Dollar change | $ | (5,835 | ) | $ | (713 | ) | |||||||||
Percentage change | (22 | )% | (1 | )% |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||||||
Selling, general and administrative expenses | $ | 32,463 | $ | 17,842 | $ | 103,143 | $ | 40,162 | |||||||
Dollar change | $ | 14,621 | $ | 62,981 | |||||||||||
Percentage change | 82 | % | 157 | % |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||||||
Interest income and other, net | $ | 3,059 | $ | 276 | $ | 4,010 | $ | 146 | |||||||
Interest expense | (7,834 | ) | (10,037 | ) | (28,575 | ) | (30,501 | ) | |||||||
Loss on extinguishment of debt | (13,773 | ) | — | (13,773 | ) | — | |||||||||
Total other income (expense), net | $ | (18,548 | ) | $ | (9,761 | ) | $ | (38,338 | ) | $ | (30,355 | ) | |||
Dollar change | $ | (8,787 | ) | $ | (7,983 | ) | |||||||||
Percentage change | 90 | % | 26 | % |
Nine Months Ended September 30, | |||||||
2016 | 2015 | ||||||
Net loss | $ | (105,345 | ) | $ | (120,176 | ) | |
Net cash provided by (used in) operating activities | 122,582 | (106,152 | ) | ||||
Net cash (used in) provided by investing activities | (155,638 | ) | 26,068 | ||||
Net cash provided by financing activities | 2,641 | 145,331 | |||||
Net (decrease) increase in cash and cash equivalents | (30,415 | ) | 65,247 | ||||
Cash and cash equivalents at beginning of period | 141,634 | 80,395 | |||||
Cash and cash equivalents at end of period | $ | 111,219 | $ | 145,642 |
• | the commercial success of both CABOMETYX and COMETRIQ and the revenues we generate from those approved products; |
• | costs associated with maintaining our expanded sales, marketing, medical affairs and distribution capabilities for CABOMETYX in the approved advanced RCC indications and COMETRIQ in the approved MTC indications; |
• | the achievement of stated regulatory and commercial milestones under our collaboration with Ipsen; |
• | the commercial success of COTELLIC and the calculation of our share of related profits and losses for the commercialization of COTELLIC in the U.S. and royalties from COTELLIC sales outside the U.S. under our collaboration with Genentech; |
• | the outcome of our arbitration against Genentech in which we have asserted claims related to Genentech’s clinical development, pricing and commercialization of COTELLIC, and cost and revenue allocations arising from COTELLIC’s commercialization in the United States and Genentech’s counterclaim for breach of contract, seeking monetary damages and interest related to the cost allocations under the collaboration agreement; |
• | the potential regulatory approval of cabozantinib as a treatment for previously untreated advanced RCC in the United States, and in other indications both in the United States and abroad; |
• | future clinical trial results, notably the results from CELESTIAL, our phase 3 pivotal trial in patients with advanced HCC; |
• | our future investments in the expansion of our pipeline through drug discovery and corporate development activities; |
• | repayment of the Deerfield Notes (see “Part I, Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations - Certain Factors Important to Understanding Our Financial Condition and Results of Operations - Deerfield Notes” for a description of these notes) which mature on July 1, 2018, subject to a requirement to make a mandatory prepayment in each of 2017 and 2018 equal to 15% of certain revenues from collaborative arrangements (other than intercompany arrangements) received during the prior fiscal year, subject to a maximum annual prepayment amount of $27.5 million; |
• | our ability to repay the Deerfield Notes with our common stock, which we are only able to do under specified conditions; |
• | repayment of our term loan from Silicon Valley Bank, which had an outstanding balance at September 30, 2016, of $80.0 million and is due in May 2017; |
• | our ability to control costs; |
• | our ability to remain in compliance with, or amend or cause to be waived, financial covenants contained in agreements with third parties; |
• | the cost of clinical drug supply for our clinical trials; |
• | trends and developments in the pricing of oncologic therapeutics in the United States and abroad, especially in the European Union; |
• | scientific developments in the market for oncologic therapeutics and the timing of regulatory approvals for competing oncologic therapies; and |
• | the filing, maintenance, prosecution, defense and enforcement of patent claims and other intellectual property rights. |
• | the effectiveness, or perceived effectiveness, of cabozantinib in comparison to competing products; |
• | the existence of any significant side effects of cabozantinib, as well as their severity in comparison to those of any competing products; |
• | cabozantinib’s potential advantages or disadvantages in relation to alternative treatments; |
• | the timing of market entry relative to competitive treatments; |
• | indications for which cabozantinib is approved; |
• | the ability to offer cabozantinib for sale at competitive prices; |
• | relative convenience and ease of administration; |
• | the strength of sales, marketing, medical affairs and distribution support; and |
• | sufficient third-party coverage and by government and commercial and other payers. |
• | the federal Anti-Kickback Law, which constrains our business activities, including our marketing practices, educational programs, pricing policies, and relationships with healthcare providers or other entities, by prohibiting, among other things, persons and entities from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual for, |
• | federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payers that are false or fraudulent; |
• | federal criminal laws that prohibit executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters; |
• | the Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, and their implementing regulations, which impose certain requirements relating to the privacy, security and transmission of individually identifiable health information; |
• | state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payer, including commercial insurers, and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts; |
• | the Foreign Corrupt Practices Act, a U.S. law which regulates certain financial relationships with foreign government officials (which could include, for example, certain medical professionals); |
• | federal and state consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers; |
• | state and federal government price reporting laws that require us to calculate and report complex pricing metrics to government programs, where such reported priced may be used in the calculation of reimbursement and/or discounts on our marketed drugs (participation in these programs and compliance with the applicable requirements may subject us to potentially significant discounts on our products, increased infrastructure costs, and potentially limit our ability to offer certain marketplace discounts); and |
• | state and federal marketing expenditure tracking and reporting laws, which generally require certain types of expenditures in the United States to be tracked and reported (compliance with such requirements may require investment in infrastructure to ensure that tracking is performed properly, and some of these laws result in the public disclosure of various types of payments and relationships, which could potentially have a negative effect on our business and/or increase enforcement scrutiny of our activities). |
• | cabozantinib may not prove to be efficacious or may cause, or potentially cause, harmful side effects; |
• | negative or inconclusive clinical trial results may require us to conduct further testing or to abandon projects that we had expected to be promising; |
• | our competitors may discover or commercialize other compounds or therapies that show significantly improved safety or efficacy compared to cabozantinib; |
• | patient registration or enrollment in our clinical testing may be lower than we anticipate, resulting in the delay or cancellation of clinical testing; and |
• | regulators or institutional review boards may withhold authorization of cabozantinib, or delay, suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements or their determination that participating patients are being exposed to unacceptable health risks. |
• | the number of patients who ultimately participate in the clinical trial; |
• | the duration of patient follow-up that is appropriate in view of the results or required by regulatory authorities; |
• | the number of clinical sites included in the trials; and |
• | the length of time required to enroll suitable patient subjects. |
• | fund our operations and clinical trials; |
• | continue our research and development efforts; |
• | expand our sales, marketing and distribution capabilities; |
• | commercialize cabozantinib or any other future product candidates, if any such candidates receive regulatory approval for commercial sale; and |
• | fund the portion of U.S. sales and marketing costs for cobimetinib that we are obligated to fund under our collaboration with Genentech (a member of the Roche Group), or any similar costs we are obligated to fund under collaborations we may enter into in the future. |
• | the commercial success of both CABOMETYX and COMETRIQ and the revenues we generate from those approved products; |
• | costs associated with maintaining our expanded sales, marketing, medical affairs and distribution capabilities for CABOMETYX in advanced RCC and COMETRIQ in the approved MTC indications; |
• | the achievement of stated regulatory and commercial milestones under our collaboration with Ipsen; |
• | the commercial success of COTELLIC and the calculation of our share of related profits and losses for the commercialization of COTELLIC in the U.S. and royalties from COTELLIC sales outside the U.S. under our collaboration with Genentech; |
• | the outcome of our arbitration against Genentech in which we have asserted claims related to Genentech’s clinical development, pricing and commercialization of COTELLIC, and cost and revenue allocations arising from COTELLIC’s commercialization in the United States and Genentech’s counterclaim for breach of contract, seeking monetary damages and interest related to the cost allocations under the collaboration agreement; |
• | the potential regulatory approval of cabozantinib as a treatment for previously untreated advanced RCC and in other indications, both in the United States and abroad; |
• | future clinical trial results, notably the results from CELESTIAL, our phase 3 pivotal trial in patients with advanced HCC; |
• | our future investments in the expansion of our pipeline through drug discovery and corporate development activities; |
• | repayment of the Deerfield Notes (see “Part I, Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations - Certain Factors Important to Understanding Our Financial Condition and Results of Operations - Deerfield Notes” for a description of these notes) which mature on July 1, 2018, subject to a requirement to make a mandatory prepayment in each of 2017 and 2018 equal to 15% of certain revenues from collaborative arrangements (other than intercompany arrangements) received during the prior fiscal year, subject to a maximum annual prepayment amount of $27.5 million; |
• | our ability to repay the Deerfield Notes with our common stock, which we are only able to do under specified conditions; |
• | repayment of our term loan from Silicon Valley Bank, which had an outstanding balance at September 30, 2016, of $80.0 million and is due in May 2017; |
• | our ability to control costs; |
• | our ability to remain in compliance with, or amend or cause to be waived, financial covenants contained in agreements with third parties; |
• | the cost of clinical drug supply for our clinical trials; |
• | trends and developments in the pricing of oncologic therapeutics in the United States and abroad, especially in the European Union; |
• | scientific developments in the market for oncologic therapeutics and the timing of regulatory approvals for competing oncologic therapies; and |
• | the filing, maintenance, prosecution, defense and enforcement of patent claims and other intellectual property rights. |
• | making it more difficult for us to meet our payment and other obligations under the Deerfield Notes and our loan and security agreement with Silicon Valley Bank or our other indebtedness; |
• | resulting in an event of default if we fail to comply with the covenants contained in our debt agreements, which event of default could result in all of our debt becoming immediately due and payable; |
• | increasing our vulnerability to adverse economic and industry conditions; |
• | subjecting us to the risk of increased sensitivity to interest rate increases on our indebtedness with variable interest rates, including borrowings under our loan and security agreement with Silicon Valley Bank; |
• | limiting our ability to obtain additional financing; |
• | requiring the dedication of a substantial portion of our cash flow from operations to service our indebtedness, thereby reducing the amount of our cash flow available for other purposes, including clinical trials, research and development, capital expenditures, working capital and other general corporate purposes; |
• | limiting our flexibility in planning for, or reacting to, changes in our business; |
• | dilution experienced by our existing stockholders as a result of the conversion of the Deerfield Notes into shares of common stock; and |
• | placing us at a possible competitive disadvantage with less leveraged competitors and competitors that may have better access to capital resources. |
• | we are not able to control the amount and timing of resources that our collaborators or potential future collaborators will devote to the development or commercialization of drug candidates or to their marketing and distribution; |
• | we are not able to control the U.S. commercial resourcing decisions made and resulting costs incurred by Genentech for cobimetinib, which reasonable costs we are obligated to share, in part, under our collaboration agreement with Genentech; |
• | collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a drug candidate, repeat or conduct new clinical trials or require a new formulation of a drug candidate for clinical testing; |
• | disputes may arise between us and our collaborators that result in the delay or termination of the research, development or commercialization of our drug candidates, or that diminish or delay receipt of the economic benefits we are entitled to receive under the collaboration, or that result in costly litigation or arbitration that diverts management’s attention and resources, such as the demand for arbitration we filed on June 3, 2016 asserting claims against Genentech for breaches of the collaboration agreement connected with its clinical development, pricing and commercialization of COTELLIC, and cost and revenue allocations arising from COTELLIC’s commercialization in the United States; |
• | collaborators may experience financial difficulties; |
• | collaborators may not be successful in their efforts to obtain regulatory approvals in a timely manner, or at all; |
• | collaborators may not properly maintain or defend our intellectual property rights or may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our proprietary information or expose us to potential litigation; |
• | collaborators may not comply with applicable healthcare regulatory laws; |
• | business combinations or significant changes in a collaborator’s business strategy may adversely affect a collaborator’s willingness or ability to complete its obligations under any arrangement; |
• | a collaborator could independently move forward with a competing drug candidate developed either independently or in collaboration with others, including our competitors; |
• | we may be precluded from entering into additional collaboration arrangements with other parties in an area or field of exclusivity; |
• | future collaborators may require us to relinquish some important rights, such as marketing and distribution rights; and |
• | collaborations may be terminated or allowed to expire, which would delay, and may increase the cost of development of our drug candidates. |
• | the commercial success of both CABOMETYX and COMETRIQ and the revenues we generate from those approved products; |
• | customer ordering patterns for CABOMETYX and COMETRIQ, which may vary significantly from period to period; |
• | the overall level of demand for CABOMETYX and COMETRIQ, including the impact of any competitive products and the duration of therapy for patients receiving CABOMETYX or COMETRIQ; |
• | costs associated with maintaining our expanded sales, marketing, medical affairs and distribution capabilities for CABOMETYX and COMETRIQ; |
• | our ability to obtain regulatory approval for cabozantinib as a treatment of first-line advanced RCC; |
• | the achievement of stated regulatory and commercial milestones, under our collaboration with Ipsen; |
• | the outcome of our arbitration against Genentech in which we have asserted claims related to Genentech’s clinical development, pricing and commercialization of COTELLIC, and cost and revenue allocations arising from COTELLIC’s commercialization in the United States and Genentech’s counterclaim for breach of contract, seeking monetary damages and interest related to the cost allocations under the collaboration agreement; |
• | the progress and scope of other development and commercialization activities for cabozantinib and our other compounds; |
• | future clinical trial results, notably the results from CELESTIAL, our phase 3 pivotal trial in patients with advanced HCC; |
• | our future investments in the expansion of our pipeline through drug discovery and corporate development activities; |
• | the inability to obtain adequate product supply for any approved drug product or inability to do so at acceptable prices; |
• | recognition of upfront licensing or other fees or revenues; |
• | payments of non-refundable upfront or licensing fees, or payment for cost-sharing expenses, to third parties; |
• | the success rate of our efforts leading to milestone payments and royalties; |
• | the introduction of new technologies or products by our competitors; |
• | the timing and willingness of collaborators to further develop or, if approved, commercialize our product candidates out-licensed to them; |
• | the termination or non-renewal of existing collaborations or third party vendor relationships; |
• | regulatory actions with respect to our product candidates and any approved products or our competitors’ products; |
• | disputes or other developments relating to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our technologies; |
• | the timing and amount of expenses incurred for clinical development and manufacturing of cabozantinib; |
• | adjustments to expenses accrued in prior periods based on management’s estimates after the actual level of activity relating to such expenses becomes more certain; |
• | the impairment of acquired goodwill and other assets; |
• | additions and departures of key personnel; |
• | general and industry-specific economic conditions that may affect our or our collaborators’ research and development expenditures; and |
• | other factors described in this “Risk Factors” section. |
• | adverse results or delays in our or our collaborators’ clinical trials; |
• | announcement of FDA approval or non-approval, or delays in the FDA review process, of cabozantinib or our collaborators’ product candidates or those of our competitors or actions taken by regulatory agencies with respect to our, our collaborators’ or our competitors’ clinical trials; |
• | the commercial success of both CABOMETYX and COMETRIQ and the revenues we generate from those approved products; |
• | the timing of achievement of our clinical, regulatory, partnering and other milestones, such as the commencement of clinical development, the completion of a clinical trial, the filing for regulatory approval or the establishment of collaborative arrangements for cabozantinib or any of our other programs or compounds; |
• | actions taken by regulatory agencies with respect to cabozantinib or our clinical trials for cabozantinib; |
• | the announcement of new products by our competitors; |
• | quarterly variations in our or our competitors’ results of operations; |
• | developments in our relationships with our collaborators, including the termination or modification of our agreements; |
• | conflicts or litigation with our collaborators, including the outcome of our arbitration with Genentech regarding COTELLIC; |
• | litigation, including intellectual property infringement and product liability lawsuits, involving us; |
• | failure to achieve operating results projected by securities analysts; |
• | changes in earnings estimates or recommendations by securities analysts; |
• | financing transactions; |
• | developments in the biotechnology, biopharmaceutical or pharmaceutical industry; |
• | sales of large blocks of our common stock or sales of our common stock by our executive officers, directors and significant stockholders; |
• | departures of key personnel or board members; |
• | FDA or international regulatory actions; |
• | third-party coverage and reimbursement policies; |
• | disposition of any of our technologies or compounds; and |
• | general market, economic and political conditions and other factors, including factors unrelated to our operating performance or the operating performance of our competitors. |
• | a classified Board of Directors; |
• | a prohibition on actions by our stockholders by written consent; |
• | the inability of our stockholders to call special meetings of stockholders; |
• | the ability of our Board of Directors to issue preferred stock without stockholder approval, which could be used to institute a “poison pill” that would work to dilute the stock ownership of a potential hostile acquirer, effectively preventing acquisitions that have not been approved by our Board of Directors; |
• | limitations on the removal of directors; and |
• | advance notice requirements for director nominations and stockholder proposals. |
EXELIXIS, INC. | ||||
November 3, 2016 | /s/ CHRISTOPHER J. SENNER | |||
Date | Christopher J. Senner | |||
Executive Vice President and Chief Financial Officer | ||||
(Duly Authorized Officer and Principal Financial and Accounting Officer) |
Exhibit Number | Exhibit Description | Incorporation by Reference | Filed Herewith | |||||||||
Form | File Number | Exhibit/ Appendix Reference | Filing Date | |||||||||
3.1 | Amended and Restated Certificate of Incorporation of Exelixis, Inc. | 10-K | 000-30235 | 3.1 | 3/10/2010 | |||||||
3.2 | Certificate of Amendment of Amended and Restated Certificate of Incorporation of Exelixis, Inc. | 10-K | 000-30235 | 3.2 | 3/10/2010 | |||||||
3.3 | Certificate of Amendment of Amended and Restated Certificate of Incorporation of Exelixis, Inc. | 8-K | 000-30235 | 3.1 | 5/25/2012 | |||||||
3.4 | Certificate of Ownership and Merger Merging X-Ceptor Therapeutics, Inc. with and into Exelixis, Inc. | 8-K | 000-30235 | 3.1 | 10/15/2014 | |||||||
3.5 | Certificate of Change of Registered Agent and/or Registered Office of Exelixis, Inc. | 8-K | 000-30235 | 3.2 | 10/15/2014 | |||||||
3.6 | Amended and Restated Bylaws of Exelixis, Inc. | 8-K | 000-30235 | 3.1 | 12/5/2011 | |||||||
4.1 | Specimen Common Stock Certificate. | S-1, as amended | 333-96335 | 4.1 | 4/7/2000 | |||||||
4.2 | Amended and Restated Secured Convertible Note dated July 1, 2015 in favor of Deerfield Partners, L.P. | 10-Q | 000-30235 | 4.2 | 8/11/2015 | |||||||
4.3 | Amended and Restated Secured Convertible Note dated July 1, 2015 in favor of Deerfield International Master Fund, L.P. | 10-Q | 000-30235 | 4.3 | 8/11/2015 | |||||||
4.4 | Registration Rights Agreement dated January 22, 2014 by and among Exelixis, Inc., Deerfield Partners, L.P. and Deerfield International Master Fund, L.P. | 8-K | 000-30235 | 4.2 | 1/22/2014 | |||||||
4.5 | Form of Warrant to Purchase Common Stock of Exelixis, Inc. issued to OTA LLC | 10-Q | 000-30235 | 4.5 | 11/10/2015 | |||||||
4.6 | Indenture dated August 14, 2012 by and between Exelixis, Inc. and Wells Fargo Bank, National Association | 8-K | 000-30235 | 4.1 | 8/14/2012 | |||||||
4.7 | First Supplemental Indenture dated August 14, 2012 to Indenture dated August 14, 2012 by and between Exelixis, Inc. and Wells Fargo Bank, National Association | 8-K | 000-30235 | 4.2 | 8/14/2012 | |||||||
4.8 | Form of 4.25% Convertible Senior Subordinated Note due 2019 | 8-K | 000-30235 | 4.2 (Exhibit A) | 8/14/2012 | |||||||
10.1 | Form of Exchange Agreement Related to 4.25% Convertible Senior Subordinated Notes | 8-K | 000-30235 | 99.1 | 8/9/2016 | |||||||
10.2 | Form of Exchange Agreement Related to 4.25% Convertible Senior Subordinated Notes | 8-K | 000-30235 | 99.1 | 8/22/2016 | |||||||
12.1 | Statement Re Computation of Earnings to Fixed Charges | X | ||||||||||
31.1 | Certification required by Rule 13a-14(a) or Rule 15d-14(a). | X |
Exhibit Number | Exhibit Description | Incorporation by Reference | Filed Herewith | |||||||||
Form | File Number | Exhibit/ Appendix Reference | Filing Date | |||||||||
31.2 | Certification required by Rule 13a-14(a) or Rule 15d-14(a). | X | ||||||||||
32.1‡ | Certification by the Chief Executive Officer and the Chief Financial Officer of Exelixis, Inc., as required by Rule 13a-14(b) or Rule 15d-14(b) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. 1350). | X | ||||||||||
101.INS | XBRL Instance Document | X | ||||||||||
101.SCH | XBRL Taxonomy Extension Schema Document | X | ||||||||||
101.CAL | XBRL Taxonomy Extension Calculation Linkbase Document | X | ||||||||||
101.DEF | XBRL Taxonomy Extension Definition Linkbase Document | X | ||||||||||
101.LAB | XBRL Taxonomy Extension Labels Linkbase Document | X | ||||||||||
101.PRE | XBRL Taxonomy Extension Presentation Linkbase Document | X |
‡ | This certification accompanies this Quarterly Report on Form 10-Q, is not deemed filed with the SEC and is not to be incorporated by reference into any filing of Exelixis, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of this Quarterly Report on Form 10-Q), irrespective of any general incorporation language contained in such filing. |
Nine Months Ended September 30, | Year Ended December 31, | ||||||||||||||||||
2016 | 2015 | 2014 | 2013 | 2012 | |||||||||||||||
Fixed charges: | |||||||||||||||||||
Interest expense | $ | 28,575 | $ | 40,680 | $ | 41,362 | $ | 38,779 | $ | 24,778 | |||||||||
Interest portion of rental expense | 564 | 755 | 886 | 935 | 2,948 | ||||||||||||||
Total fixed charges | $ | 29,139 | $ | 41,435 | $ | 42,248 | $ | 39,714 | $ | 27,726 | |||||||||
Earnings available for fixed charges: | |||||||||||||||||||
Net loss before income taxes | $ | (105,345 | ) | $ | (161,689 | ) | $ | (261,479 | ) | $ | (238,288 | ) | $ | (145,228 | ) | ||||
Fixed charges per above | 29,139 | 41,435 | 42,248 | 39,714 | 27,726 | ||||||||||||||
Total earnings available for fixed charges | $ | (76,206 | ) | $ | (120,254 | ) | $ | (219,231 | ) | $ | (198,574 | ) | $ | (117,502 | ) | ||||
Ratio of earnings to fixed charges | N/A | N/A | N/A | N/A | N/A | ||||||||||||||
Deficiency of earnings available to cover fixed charges | $ | (105,345 | ) | $ | (161,689 | ) | $ | (261,479 | ) | $ | (238,288 | ) | $ | (145,228 | ) |
/s/ MICHAEL M. MORRISSEY |
Michael M. Morrissey, Ph.D. |
President and Chief Executive Officer (Principal Executive Officer) |
/s/ CHRISTOPHER J. SENNER |
Christopher J. Senner |
Executive Vice President and Chief Financial Officer (Principal Financial Officer) |
/s/ MICHAEL M. MORRISSEY | /s/ CHRISTOPHER J. SENNER | |||
Michael M. Morrissey, Ph.D. | Christopher J. Senner | |||
President and Chief Executive Officer (Principal Executive Officer) | Executive Vice President and Chief Financial Officer (Principal Financial Officer) |
Document And Entity Information - shares |
9 Months Ended | |
---|---|---|
Sep. 30, 2016 |
Oct. 26, 2016 |
|
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2016 | |
Document Fiscal Year Focus | 2016 | |
Document Fiscal Period Focus | Q3 | |
Trading Symbol | exel | |
Entity Registrant Name | EXELIXIS, INC. | |
Entity Central Index Key | 0000939767 | |
Entity Filer Category | Large Accelerated Filer | |
Current Fiscal Year End Date | --12-30 | |
Entity Common Stock, Shares Outstanding | 286,455,917 |
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares |
Sep. 30, 2016 |
Dec. 31, 2015 |
---|---|---|
Statement of Financial Position [Abstract] | ||
Common stock, par value, in dollars per share | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 400,000,000 | 400,000,000 |
Common stock, shares issued | 286,123,166 | 227,960,943 |
Common stock, shares outstanding | 286,123,166 | 227,960,943 |
Condensed Consolidated Statements of Operations - USD ($) shares in Thousands, $ in Thousands |
3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Sep. 30, 2016 |
Sep. 30, 2015 |
Sep. 30, 2016 |
Sep. 30, 2015 |
|
Revenues: | ||||
Net product revenues | $ 42,742 | $ 6,854 | $ 83,459 | $ 24,234 |
Royalty, license and contract revenues | 19,452 | 3,000 | 30,414 | 3,000 |
Total revenues | 62,194 | 9,854 | 113,873 | 27,234 |
Operating expenses: | ||||
Cost of goods sold | 2,455 | 1,420 | 4,700 | 2,872 |
Research and development | 20,256 | 26,091 | 72,166 | 72,879 |
Selling, general and administrative | 32,463 | 17,842 | 103,143 | 40,162 |
Restructuring (recovery) charge | (244) | 282 | 871 | 1,142 |
Total operating expenses | 54,930 | 45,635 | 180,880 | 117,055 |
Income (loss) from operations | 7,264 | (35,781) | (67,007) | (89,821) |
Other income (expense), net: | ||||
Interest income and other, net | 3,059 | 276 | 4,010 | 146 |
Interest expense | (7,834) | (10,037) | (28,575) | (30,501) |
Loss on extinguishment of debt | (13,773) | 0 | (13,773) | 0 |
Total other income (expense), net | (18,548) | (9,761) | (38,338) | (30,355) |
Net loss | $ (11,284) | $ (45,542) | $ (105,345) | $ (120,176) |
Net loss per share, basic and diluted, in dollars per share | $ (0.04) | $ (0.21) | $ (0.44) | $ (0.59) |
Shares used in computing basic and diluted net loss per share, in shares | 256,319 | 217,587 | 238,024 | 203,153 |
Condensed Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands |
3 Months Ended | 9 Months Ended | ||||
---|---|---|---|---|---|---|
Sep. 30, 2016 |
Sep. 30, 2015 |
Sep. 30, 2016 |
Sep. 30, 2015 |
|||
Statement of Comprehensive Income [Abstract] | ||||||
Net loss | $ (11,284) | $ (45,542) | $ (105,345) | $ (120,176) | ||
Other comprehensive income (loss) | [1] | (209) | 133 | 152 | 80 | |
Comprehensive loss | $ (11,493) | $ (45,409) | $ (105,193) | $ (120,096) | ||
|
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands |
9 Months Ended | ||||
---|---|---|---|---|---|
Sep. 30, 2016 |
Sep. 30, 2015 |
||||
Cash flows from operating activities: | |||||
Net loss | $ (105,345) | $ (120,176) | |||
Adjustments to reconcile net loss to net cash provided by (used in) operating activities: | |||||
Depreciation and amortization | 754 | 1,063 | |||
Stock-based compensation expense | 18,346 | 15,420 | |||
Accretion of debt discount and debt issuance costs | 8,295 | 14,274 | |||
Accrual of interest paid in kind | 5,939 | 1,890 | |||
Gain on sale of equity investment | (2,494) | (95) | |||
Loss on extinguishment of debt | 13,773 | 0 | |||
Change in the fair value of warrants | 0 | 549 | |||
Other | (1,381) | 1,338 | |||
Changes in assets and liabilities: | |||||
Trade and other receivables | (85,923) | 1,034 | |||
Inventory | (676) | 259 | |||
Prepaid expenses and other current assets | (3,342) | (1,940) | |||
Other long term assets | 535 | 1,832 | |||
Accounts payable, accrued compensation and benefits, and other accrued liabilities | 18,816 | (14,293) | |||
Accrued collaboration liability | 7,772 | 8,400 | |||
Clinical trial liabilities | (3,184) | (11,757) | |||
Deferred revenue | 251,512 | (2,583) | |||
Other long-term liabilities | (815) | (1,367) | |||
Net cash provided by (used in) operating activities | 122,582 | (106,152) | |||
Cash flows from investing activities: | |||||
Purchases of property and equipment | (1,116) | (114) | |||
Proceeds from sale of property and equipment | 92 | 1,300 | |||
Proceeds from sale of equity investments | 2,494 | 95 | |||
Proceeds from maturities of restricted cash and investments | 2,650 | 16,754 | |||
Purchase of restricted cash and investments | (4,150) | (2,616) | |||
Proceeds from sale of investments | 2,266 | 0 | |||
Proceeds from maturities of investments | 100,635 | 130,341 | |||
Purchases of investments | (258,509) | (119,692) | |||
Net cash (used in) provided by investing activities | (155,638) | 26,068 | |||
Cash flows from financing activities: | |||||
Proceeds from issuance of common stock, net | 0 | 145,651 | |||
Proceeds from exercise of stock options | 9,296 | 3,787 | |||
Proceeds from employee stock purchase plan | 479 | 274 | |||
Principal payments on debt | 0 | (4,381) | |||
Payments on conversion of convertible notes | (7,134) | 0 | |||
Net cash provided by financing activities | 2,641 | 145,331 | |||
Net (decrease) increase in cash and cash equivalents | (30,415) | 65,247 | |||
Cash and cash equivalents at beginning of period | 141,634 | [1] | 80,395 | ||
Cash and cash equivalents at end of period | 111,219 | 145,642 | |||
Supplemental cash flow disclosure - non-cash financing activity: | |||||
Issuance of common stock in settlement of convertible notes | $ 285,308 | $ 0 | |||
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Organization and Summary of Significant Accounting Policies |
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Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Organization and Summary of Significant Accounting Policies | ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Organization Exelixis, Inc. (“Exelixis,” “we,” “our” or “us”) is a biopharmaceutical company committed to the discovery, development and commercialization of new medicines that will improve care and outcomes for people with cancer. Since its founding in 1994, three products discovered at Exelixis have progressed through clinical development, received regulatory approval, and entered the commercial marketplace. This portfolio includes two products derived from cabozantinib, an inhibitor of multiple tyrosine kinases including MET, AXL, and VEGF receptors. They are CABOMETYX™ tablets for the treatment of advanced kidney cancer and COMETRIQ® capsules for the treatment of certain forms of thyroid cancer, each approved both in the United States and European Union. The third product is COTELLIC®, a product derived from cobimetinib, a selective inhibitor of MEK, marketed under a collaboration with Roche and Genentech (a member of the Roche Group) that has been approved in combination with ZELBORAF® (vemurafenib) to treat advanced melanoma in several major territories, including the United States and European Union. Basis of Consolidation The condensed consolidated financial statements include the accounts of Exelixis and those of our wholly-owned subsidiaries. These entities’ functional currency is the U.S. dollar. All intercompany balances and transactions have been eliminated. Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States for interim financial information and pursuant to Form 10-Q and Article 10 of Regulation S-X of the Securities and Exchange Commission (“SEC”). Accordingly, they do not include all of the information and footnotes required by U.S. generally accepted accounting principles for complete financial statements. In our opinion, all adjustments (consisting only of normal recurring adjustments) considered necessary for a fair presentation of the results of operations and cash flows for the periods presented have been included. We adopted a 52- or 53-week fiscal year that generally ends on the Friday closest to December 31st. Fiscal year 2016 will end on December 30, 2016, and fiscal year 2015, ended on January 1, 2016. For convenience, references in this report as of and for the fiscal periods ended September 30, 2016, and October 2, 2015, and as of and for the fiscal years ended December 30, 2016 and January 1, 2016, are indicated as being as of and for the periods ended September 30, 2016, September 30, 2015, and the years ended December 31, 2016, and December 31, 2015, respectively. Operating results for the nine months ended September 30, 2016 are not necessarily indicative of the results that may be expected for the year ending December 31, 2016 or for any future period. These financial statements and notes should be read in conjunction with the consolidated financial statements and notes thereto for the year ended December 31, 2015, included in our Annual Report on Form 10-K filed with the SEC on February 29, 2016. 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 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 has 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 would not be 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 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:
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:
These errors did not affect any other caption or total in our unaudited condensed or annual consolidated financial statements. Segment Information We operate as a single reportable segment. Use of Estimates The preparation of our consolidated financial statements is in conformity with accounting principles generally accepted in the United States that requires management to make judgments, estimates and assumptions that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosures. On an ongoing basis, management evaluates its estimates including, but not limited to, those related to revenue recognition, including for deductions from revenues (such as rebates, chargebacks, sales returns and sales allowances) and the period of performance, identification of deliverables and evaluation of milestones with respect to our collaborations, recoverability of inventory, certain accrued liabilities including clinical trial and collaboration liability accruals, the valuation of the debt and equity components of our convertible debt and share-based compensation. We base our estimates on historical experience and on various other market-specific and other relevant assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results could differ materially from those estimates. Limited Sources of Revenues and the Need to Raise Additional Capital We have incurred net losses since inception through September 30, 2016, with the exception of the 2011 fiscal year. For the nine months ended September 30, 2016, we incurred a net loss of $105.3 million and as of September 30, 2016, we had an accumulated deficit of $2.0 billion. These losses have had an adverse effect on our stockholders’ equity and working capital. Because of the numerous risks and uncertainties associated with developing drugs, we are unable to predict the extent of any future losses or when we will become profitable. Excluding fiscal 2011, our research and development expenditures and selling, general and administrative expenses have exceeded our revenues for each fiscal year, and we expect to spend significant additional amounts to fund the continued development and commercialization of cabozantinib. In addition, we are evaluating the expansion of our pipeline through drug discovery and corporate development activities. As a result, we expect to continue to incur substantial operating expenses and, consequently, we will need to generate significant additional revenues to achieve future profitability. Other than sales of CABOMETYX and COMETRIQ, which have totaled $157.7 million in net product revenues since the first commercial launch in January 2013, we have derived substantially all of our revenues since inception from collaborative research and development agreements, which depend on royalties, license fees, the achievement of milestones, and research funding we earn from any products developed from the collaborative research. The amount of our net losses will depend, in part, on: the level of sales of CABOMETYX and COMETRIQ in the United States; achievement of clinical, regulatory and commercial milestones and the amount of royalties, if any, from sales of CABOMETYX and COMETRIQ under our collaboration with Ipsen Pharma SAS (“Ipsen”); our share of the net profits and losses for the commercialization of COTELLIC in the U.S. under our collaboration with Genentech (a member of the Roche group); the amount of royalties from COTELLIC sales outside the U.S. under our collaboration with Genentech; other license and contract revenues; and, the level of our expenses, including commercialization activities for cabozantinib and any pipeline expansion efforts. As of September 30, 2016, we had $379.6 million in cash and investments, which included $293.8 million available for operations, $81.6 million of compensating balance investments that we are required to maintain on deposit with Silicon Valley Bank, and $4.2 million of long-term restricted investments. We anticipate that our current cash and cash equivalents, and short-term investments available for operations, and product revenues, will enable us to maintain our operations for a period of at least 12 months following the filing date of this report. Our capital requirements will depend on many factors, and we may need to use available capital resources and raise additional capital significantly earlier than we currently anticipate. Revenue Recognition We recognize revenue from product sales and from license fees, milestones, contingent payments and royalties earned on research, collaboration and license arrangements. See “Note 1 - Organization and Summary of Significant Accounting Policies” to our Consolidated Financial Statements included in our Annual Report on Form 10-K for the year ended December 31, 2015 for a description of our revenue recognition policies for product sales discounts and allowances, license and contract revenues under our collaboration agreement with Genentech and our Patient Assistance Program. Net Product Revenues We recognize revenue when it is both realized or realizable and earned, meaning persuasive evidence of an arrangement exists, delivery has occurred, title has transferred, the price is fixed or determinable, there are no remaining customer acceptance requirements, and collectability of the resulting receivable is reasonably assured. For product sales in the United States, this generally occurs upon delivery of the product to a specialty pharmacy or distributor. For product sales to our distribution partner, Swedish Orphan Biovitrum (“Sobi”), this generally occurs when Sobi has accepted the product. For product sales to our collaboration partner Ipsen, this generally occurs upon delivery. In the United States, we sell our products, CABOMETYX and COMETRIQ, to specialty pharmacies and distributors that benefit from customer incentives and have a right of return 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 payors at the time of shipment to the specialty pharmacy. Accordingly, beginning in January 2015 we began to recognize revenue upon delivery to the specialty pharmacy. This approach is frequently referred to as the “sell-in” revenue recognition model. In connection with the change in the timing of recognition of U.S. COMETRIQ sales, we recorded a one-time adjustment to recognize revenue that had previously been deferred under the “sell-through” revenue recognition model, resulting in the additional recognition of gross product revenues of $2.6 million for the nine months ended September 30, 2015; there were no such additional amounts recorded during the comparable period in 2016. In determining discounts and allowances for the initial launch and sale of CABOMETYX, in addition to using payer data received from the specialty pharmacies and distributors that sell CABOMETYX and historical data for COMETRIQ, we also utilized claims data from third party sources for competitor products for the treatment of advanced 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 nine months ended September 30, 2016 were impacted by the build of channel inventory related to the initial launch period for CABOMETYX. We also utilize the “sell-in” revenue recognition model for product sales to Sobi for all periods presented. Once Sobi has accepted the product, the product is generally no longer subject to return; therefore, we record revenue at the time Sobi has accepted the product. As described further in “Note 2 - Research and Collaboration Agreements”, under the terms of our collaboration and license agreement with Ipsen for the commercialization and further development of cabozantinib, we provided Sobi with a notice of termination of our commercialization agreement for COMETRIQ which will become effective November 1, 2016. We expect to repurchase the remaining product on hand from Sobi following the termination. As of September 30, 2016, we recorded allowances for expected future returns totaling $0.4 million; there were no such allowances recorded as of December 31, 2015 or September 30, 2015. For product sales to Ipsen, which began during the three months ended September 30, 2016, we utilize the “sell-in” revenue recognition model. Once title has transferred to Ipsen, the product is generally no longer subject to return; therefore, we record revenue at the time product is delivered. Royalty, License and Contract Revenues We enter into corporate collaboration and license agreements under which we may obtain upfront license fees, research funding, and contingent, milestone and royalty payments. These arrangements have multiple elements and our deliverables may include intellectual property rights, distribution rights, delivery of manufactured product, 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 continued involvement. Amounts received in advance of performance are recorded as deferred revenue. Upfront fees are classified as license revenues in our consolidated statements of operations. We consider sales-based contingent payments to be royalty revenue which is generally recognized at the date the contingency is achieved. Royalties are recorded based on sales amounts reported to us for the preceding quarter. For certain contingent payments under collaboration and license arrangements, we recognize revenue using the milestone method. Under the milestone method a payment that is contingent upon the achievement of a substantive milestone is recognized in its entirety in the period in which the milestone is achieved. A milestone is an event: (i) that can be achieved based in whole or in part on either our performance or on the occurrence of a specific outcome resulting from our performance, (ii) for which there is substantive uncertainty at the date the arrangement is entered into that the event will be achieved and (iii) that would result in additional payments being due to us. The determination that a milestone is substantive requires estimation and judgment and is made at the inception of the arrangement. Milestones are considered substantive when the consideration earned from the achievement of the milestone is: (i) commensurate with either our performance to achieve the milestone or the enhancement of value of the item delivered as a result of a specific outcome resulting from our performance to achieve the milestone, (ii) relates solely to past performance and (iii) reasonable relative to all deliverables and payment terms in the arrangement. In making the determination as to whether a milestone is substantive or not, we consider all facts and circumstances relevant to the arrangement, including factors such as the scientific, regulatory, commercial and other risks that must be overcome to achieve the respective milestone, the level of effort and investment required to achieve the respective milestone and whether any portion of the milestone consideration is related to future performance or deliverables. Recent Accounting Pronouncements In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Updates (“ASU”) No. 2014-09, Revenue from Contracts with Customers, (“ASU 2014-09”). ASU 2014-09 will replace most existing revenue recognition guidance when it becomes effective and permits the use of either the retrospective or cumulative effect transition method. In August 2015, the FASB issued an update to defer the effective date of this update 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 if we so choose. We currently plan to adopt this accounting standard in the first quarter of fiscal year 2018. We have not yet selected a transition method and are evaluating the effect that ASU 2014-09 will have on our Consolidated Financial Statements and related disclosures. In April 2015, the FASB issued Accounting Standards Update No. 2015-05, Customer’s Accounting for Fees Paid in a Cloud Computing Arrangement, (“ASU 2015-05”). ASU 2015-05 provides guidance to customers about whether a cloud computing arrangement includes a software license. If a cloud computing arrangement includes a software license, then the customer should account for the software license element of the arrangement consistent with the acquisition of other software licenses. If a cloud computing arrangement does not include a software license, the customer should account for the arrangement as a service contract. ASU 2015-05 was effective for all interim and annual reporting periods beginning after December 15, 2015 and therefore we adopted ASU 2015-05 in the three months ended March 31, 2016 on a prospective basis. The adoption of ASU 2015-05 did not have a material impact on our Condensed Consolidated Statements of Operations during the period of adoption and is not expected to have a material effect on our Consolidated Financial Statements in future periods. 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 are 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 condensed consolidated financial statements. In March 2016, the FASB issued Accounting Standards Update No. 2016-09, Improvements to Employee Share-Based Payment Accounting, (“ASU 2016-09”). ASU 2016-09 is aimed at the simplification of several aspects of the accounting for employee share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities, and classification on the statement of cash flows. ASU 2016-09 is effective for all interim and annual reporting periods beginning after December 15, 2016. Early adoption is permitted. We 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 Accounting Standards Update No. 2016-15, Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments, (“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. We do not expect the adoption of ASU 2016-15 to have a material impact on our Consolidated Statements of Cash Flows. |
Research and Collaboration Agreements |
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Sep. 30, 2016 | |
Research And Collaboration Agreements [Abstract] | |
Research and Collaboration Agreements | RESEARCH AND COLLABORATION AGREEMENTS Ipsen Collaboration On February 29, 2016, we entered into a collaboration and license agreement (the “Agreement”) with Ipsen for the commercialization and further development of cabozantinib. Pursuant to the terms of the Agreement, Ipsen will have exclusive commercialization rights for current and potential future cabozantinib indications outside of the United States, Canada and Japan. We have 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 Agreement, Ipsen paid us an upfront nonrefundable payment of $200.0 million in March 2016. As a result of the approval of cabozantinib by the European Medicines Agency (“EMA”) in second-line RCC in September 2016, we achieved a $60.0 million milestone which we expect to receive in November 2016. We will be eligible to receive additional development and regulatory milestones, totaling up to $240.0 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, and additional milestones for other future indications. We will also be eligible to receive two $10.0 million milestone payments upon the launch of the product in the first two of the following countries: Germany, France, Italy, Spain and the United Kingdom. The Agreement also provides that we will be eligible to receive contingent payments of up to $525.0 million associated with the achievement of specified levels of Ipsen sales to end users. We will also receive royalties on net sales of cabozantinib outside of the United States, Canada and Japan. We will receive a 2% royalty on the initial $50.0 million of net sales, and a 12% royalty on the next $100.0 million of net sales. After the initial $150.0 million of sales, we will receive a tiered royalty of 22% to 26% on annual net sales; these tiers will reset each calendar year. We are primarily responsible for funding cabozantinib related development costs for existing trials; global development costs for potential future trials will be shared between the parties, with Ipsen to reimburse us for 35% of such costs. Pursuant to the terms of the Agreement, we will remain responsible for the manufacture and supply of cabozantinib for all development and commercialization activities under the Agreement. As part of the Agreement, we entered into a supply agreement which provides that through the end of the second quarter of 2018, we will supply finished, labeled product to Ipsen for distribution in the territories outside of the United States, Canada and Japan. From the end of the second quarter of 2018 forward, we will continue to manufacture CABOMETYX tablets, while Ipsen will be responsible for packaging and labeling the product in territories where it has been approved outside of the United States, Canada and Japan, as applicable. The Agreement contains multiple elements, and the deliverables under the 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 Agreement) with Ipsen. These deliverables are non-contingent in nature. The Company determined that these deliverables do not have stand-alone value, because each one of them has value only if the Company meets its obligation to provide Ipsen with cabozantinib, which the Company deems to be the predominant deliverable under the Agreement. The Company also determined that the level of effort required of the Company to meet its obligations under the Agreement is not expected to vary significantly over the life of the Agreement. Accordingly, the Company combined these deliverables into a single unit of accounting and allocated the entire arrangement consideration to that combined unit of accounting. As a result, the upfront payment of $200.0 million, received in the first quarter of 2016 is being recognized ratably over the effective term of the Agreement, which continues through early 2030, 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 EMA 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 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, which we expect to receive in November 2016, and is being recognized ratably over the remaining term of the Agreement. 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 s 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 Agreement. During the three and nine months ended September 30, 2016, we have recognized $3.8 million and $8.6 million, respectively, in license revenue under the Agreement. As of September 30, 2016, short-term and long-term deferred revenue relating to the Agreement was $18.9 million and $232.6 million, respectively. In connection with the establishment of the Agreement with Ipsen, we provided Sobi with a notice of termination of our distribution and commercialization agreement for COMETRIQ. Effective November 1, 2016, Ipsen will become responsible for the distribution and commercialization of COMETRIQ for the approved medullary thyroid cancer indication in territories previously supported by Sobi. Pursuant to our commercialization agreement with Sobi we are required to pay a termination fee. As of September 30, 2016, we had a $2.7 million accrual for the estimated termination fee to be paid to Sobi and the related expense, which was recorded during the three months ended March 31, 2016, is included in Selling, general and administrative expenses in the accompanying Condensed Consolidated Statements of Operations for the nine months ended September 30, 2016. Additionally, pursuant to our commercialization agreement with Sobi, we expect to repurchase unsold product from Sobi and have recorded a returns allowance of $0.4 million as of September 30, 2016, the related charge for which is included as a reduction to Net product revenues in the accompanying Condensed Consolidated Statements of Operations. Genentech Collaboration In December 2006, we out-licensed the development and commercialization of cobimetinib to Genentech (a member of the Roche group) pursuant to a worldwide collaboration agreement. We discovered cobimetinib internally and advanced the compound to investigational new drug (“IND”) status. Genentech paid upfront and milestone payments of $25.0 million in December 2006 and $15.0 million in January 2007 upon signing of the collaboration agreement and with the submission of the IND application for cobimetinib. Under the terms of the agreement, we were responsible for developing cobimetinib through the determination of the maximum-tolerated dose in a phase 1 clinical trial, and Genentech had the option to co-develop cobimetinib, which Genentech could exercise after receipt of certain phase 1 data from us. In March 2008, Genentech exercised its option to co-develop cobimetinib. In March 2009, we granted to Genentech an exclusive worldwide revenue-bearing license to cobimetinib, at which point Genentech became responsible for completing the phase 1 clinical trial and subsequent clinical development. The U.S. Food and Drug Administration (“FDA”) approved cobimetinib in the United States under the brand name COTELLIC on November 10, 2015. It is indicated in combination with vemurafenib as a treatment for patients with BRAF V600E or V600K mutation-positive advanced melanoma. COTELLIC in combination with vemurafenib has also been approved in multiple other territories including the European Union and Canada. Under the terms of our collaboration agreement with Genentech for cobimetinib, we are entitled to a share of U.S. profits and losses in connection with the 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. We are entitled to low double-digit royalties on ex-U.S. net sales. In November 2013, we exercised an option under the collaboration agreement to co-promote in the United States. Following the approval of COTELLIC in the United States in November 2015, we began fielding 25% of the sales force promoting COTELLIC in combination with vemurafenib as a treatment for patients with BRAF V600E or V600K mutation-positive advanced melanoma. We recorded net losses of $2.9 million and $14.8 million under the collaboration agreement during the three and nine months ended September 30, 2016, respectively, as compared to $4.3 million and $11.8 million for the comparable periods in 2015; those costs are included in Selling, general and administrative expenses on the accompanying Condensed Consolidated Statements of Operations. A majority of the liability for those costs which consists of commercialization expenses that Genentech has allocated to the collaboration, but are in dispute, is identified as Accrued collaboration liability on the accompanying Condensed Consolidated Balance Sheets. On June 3, 2016, we filed a Demand for Arbitration before JAMS in San Francisco, California asserting claims against Genentech related to its clinical development, pricing and commercialization of COTELLIC, and cost and revenue allocations in connection with COTELLIC’s commercialization in the United States. Our arbitration demand asserts that Genentech has breached the parties’ contract for, amongst other breaches, failing to meet its diligence and good faith obligations. The demand seeks various forms of declaratory, monetary, and equitable relief, including without limitation that the cost and revenue allocations for COTELLIC be shared equitably consistent with the collaboration agreement’s terms, along with attorneys’ fees and costs of the arbitration. Genentech has asserted a counterclaim for breach of contract, which seeks monetary damages and interest related to the cost allocations under the collaboration agreement. We also recognized license revenues of $0.7 million and $1.8 million for royalties on ex-U.S. net sales of COTELLIC during the three and nine months ended September 30, 2016, respectively, based on sales amounts reported by Genentech for the preceding quarter. We recognized no such royalties during the comparable periods in 2015. Other Collaborations During the three and nine months ended September 30, 2016, we recognized $15.0 million in contract revenues from a milestone payment earned from Daiichi Sankyo related to its worldwide license of our compounds that modulate mineralocorticoid receptor (“MR”), including CS-3150 (an isomer of XL550). During the nine months ended September 30, 2016 and the three and nine months ended September 30, 2015, we recognized $5.0 million, $3.0 million and $3.0 million, respectively, in contract revenues from milestone payments earned from Merck related to its worldwide license of our phosphoinositide-3 kinase-delta program. See “Note 2 - Research and Collaboration Agreements” to our Consolidated Financial Statements included in our Annual Report on Form 10-K for the year ended December 31, 2015 for a description of our existing collaboration agreements. |
Restructurings |
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Restructuring Charges [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Restructurings | RESTRUCTURINGS Between March 2010 and May 2013, we implemented five restructurings (which we refer to collectively as the “2010 Restructurings”) to manage costs and as a consequence of our decision in 2010 to focus our proprietary resources and development efforts on the development and commercialization of cabozantinib. In September 2014, as a consequence of the failure of COMET-1, one of our two phase 3 pivotal trials of cabozantinib in metastatic castration-resistant prostate cancer, we initiated a restructuring (which we refer to as the “2014 Restructuring”) to enable us to focus our financial resources on the phase 3 pivotal trials of cabozantinib in advanced RCC and advanced hepatocellular carcinoma. See “Note 3 - Restructurings” to our Consolidated Financial Statements included in our Annual Report on Form 10-K for the year ended December 31, 2015 for additional information about the restructurings. For the nine months ended September 30, 2016 and 2015, we recorded a restructuring charge of $0.9 million and $1.1 million, respectively, for the restructurings. Both periods included the effect of the passage of time on our discounted cash flow computations (“accretion expense”) for the exit, in prior periods, of certain of our South San Francisco buildings. During the nine months ended September 30, 2016, the restructuring charge 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 nine months ended September 30, 2015 included $1.5 million in additional charges due to the partial termination of one of our building leases and additional facility-related charges related to the decommissioning and exit of certain buildings which was partially offset by $0.9 million in recoveries recorded in connection with the sale of excess equipment and other assets. The total outstanding restructuring liability is included in the current and long-term portion of restructuring on the accompanying Condensed Consolidated Balance Sheets. The changes of these liabilities during the nine months ended September 30, 2016, which related primarily to facilities, are summarized in the following table (in thousands):
We expect to pay accrued facility charges of $2.2 million, net of cash received from our subtenants, through the end of the lease terms of the buildings, all of which end in May 2017. We expect to incur additional restructuring charges of approximately $0.1 million relating to the effect of accretion expense through to the end of the lease terms of the buildings. |
Cash and Investments |
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Investments, Debt and Equity Securities [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Cash and Investments | CASH AND INVESTMENTS All of our cash equivalents and investments are classified as available-for-sale. The following tables summarize cash and cash equivalents, investments, and restricted cash and investments by balance sheet line item as of September 30, 2016 and December 31, 2015 (in thousands):
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 September 30, 2016 and December 31, 2015 and are reflected in our Condensed Consolidated Balance Sheets in short-term investments as of September 30, 2016 and long-term investments as of December 31, 2015; the change in classification from long-term to short-term was the result of a corresponding change in the classification for our term loan payable to Silicon Valley Bank which matures in May 2017. See “Note 7 - Debt” to our Consolidated Financial Statements included in our Annual Report on Form 10-K for the year ended December 31, 2015, for more information regarding the collateral balance requirements under our Silicon Valley Bank loan and security agreement. The following tables summarize our cash equivalents and investments by security type as of September 30, 2016 and December 31, 2015. The amounts presented exclude cash, but include investments classified as cash equivalents (in thousands):
All of our investments are subject to a quarterly impairment review. During the nine months ended September 30, 2016 and 2015, we did not record any other-than-temporary impairment charges on our available-for-sale securities. As of September 30, 2016, there were 37 investments in an unrealized loss position with gross unrealized losses of $71,000 and an aggregate fair value of $67.3 million. The investments in an unrealized loss position comprise corporate and government sponsored enterprise bonds. The unrealized losses were not attributed to credit risk, but rather associated with the changes in interest rates. Based on the scheduled maturities of our investments, we concluded that the unrealized losses in our investment securities are not other-than-temporary, as it is more likely than not that we will hold these investments for a period of time sufficient for a recovery of our cost basis. The following table summarizes the fair value of securities classified as available-for-sale by contractual maturity as of September 30, 2016 (in thousands):
Cash is excluded from the table above. |
Inventory |
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Inventory Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Inventory | INVENTORY Inventory consists of the following (in thousands):
We generally relieve inventory on a first-expiry, first-out basis. A portion of the manufacturing costs for inventory was incurred prior to regulatory approval of CABOMETYX and COMETRIQ and, therefore, were expensed as research and development costs when those costs were incurred, rather than capitalized as inventory. Write-downs related to excess and expiring inventory are charged to cost of goods sold. Such write-downs were $0.4 million for both the three and nine months ended September 30, 2016 as compared to $1.1 million and $0.9 million for the comparable periods in 2015. The non-current portion of inventory recorded as other assets consists of raw materials and a portion of the active pharmaceutical ingredient which is included in work in process. |
Debt |
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Debt Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Debt | DEBT The amortized carrying amount of our debt consists of the following (in thousands):
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. See “Note 7 - Debt” to our Consolidated Financial Statements included in our Annual Report on Form 10-K for the year ended December 31, 2015, for additional information on the terms of our debt, including a description of the conversion features of the 2019 Notes and the Deerfield Notes. 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, all of which remained outstanding at December 31, 2015. The 2019 Notes bear interest at a rate of 4.25% per annum, payable semi-annually in arrears on February 15 and August 15 of each year. 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 convert an aggregate principal amount of $239.4 million of 2019 Notes held by them in exchange for an aggregate of 45,064,456 shares of the Company’s common stock. In addition, the holders received inducements of $6.0 million which included an aggregate cash payment of $2.4 million and the forgiveness of the repayment of interest payments of $3.6 million. Further, under the terms of the indenture for the 2019 Notes, upon conversion the holders that entered into exchange agreements on August 9, 2016 were required to repay $3.6 million in interest payments that the holders of record on August 1, 2016 received on or about August 15, 2016. Under the terms of the exchange agreements, we forgave the repayment of such interest. We have included those interest payments as financing activities in our Condensed 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. Following a required 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. Subsequent to the announcement of the redemption of all remaining 2019 Notes outstanding, on various dates in August and September of 2016, $45.9 million of additional aggregate principal amount of 2019 Notes were converted by the holders into an aggregate of 8,640,455 shares of the Company’s common stock. The combined issuance of 53,704,911 shares of the Company’s common stock pursuant to the conversions resulted in an increase to common stock and additional paid-in capital of $589.2 million. 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 remaining settlement consideration transferred was allocated to the reacquisition of the embedded conversion option and recognized as a $340.5 million reduction of additional paid-in capital. Transaction costs incurred with third parties related to the settlement 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. As of September 30, 2016, $2.2 million aggregate principal amount the 2019 Notes remained outstanding. Unless converted earlier, those notes will be redeemed on November 2, 2016 in cash for 100% of the principal amount thereof, plus accrued and unpaid interest. The following is a summary of the liability component of the 2019 Notes (in thousands):
The following is a summary of the interest expense for the 2019 Notes (in thousands):
The balance of unamortized fees and costs was $26,000 and $4.2 million as of September 30, 2016 and December 31, 2015, respectively, which is recorded as a reduction of the carrying amount of the 2019 Notes on the accompanying Condensed Consolidated Balance Sheets. Deerfield Notes As of September 30, 2016 and December 31, 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. The following is a summary of the interest expense for the Deerfield Notes (in thousands):
The balance of unamortized fees and costs was $0.5 million and $0.7 million as of September 30, 2016 and December 31, 2015, respectively, which is recorded as a reduction of the carrying amount of the Deerfield Notes on the accompanying Condensed Consolidated Balance Sheets. Effective March 4, 2015, upon notification of our election to extend the maturity date to July 1, 2018, we began to amortize the remaining unamortized discount, fees and costs through July 1, 2018 using the effective interest method and an effective interest rate of 15.3%. We were required to make an additional mandatory prepayment on the Deerfield Notes in January 2015 and 2016 equal to 15% of certain revenues from collaborative arrangements, which we refer to as Development/Commercialization Revenue, received during the prior fiscal year, subject to a maximum prepayment amount of $27.5 million. We made no such mandatory prepayments due to the fact that we received no such revenues during the fiscal year ended December 31, 2014 and Deerfield elected not to receive the mandatory prepayment in January 2016 related to development/commercialization revenue received during the year ended December 31, 2015. As a result of the extension of the maturity date of the Deerfield Notes to July 1, 2018, our obligation to make annual mandatory prepayments equal to 15% of Development/Commercialization Revenue received by us during the prior fiscal year will continue to apply in January 2017 and January 2018. However, we will only be obligated to make any such annual mandatory prepayment if the note holders provide notice to us of their election to receive the prepayment. Pursuant to this requirement, we may be required make a mandatory prepayment of $27.5 million in January 2017 as a result of the upfront payment of $200.0 million upfront nonrefundable payment received in March 2016 in consideration for the exclusive license and other rights contained in the collaboration and license agreement with Ipsen and the $5.0 million milestone payment from Merck we received in the first quarter of 2016 related to its worldwide license of our phosphoinositide-3 kinase-delta program. That portion of the Deerfield Notes is included in current liabilities. The definition of “Development/Commercialization Revenue” expressly excludes any sale or distribution of drug or pharmaceutical products in the ordinary course of our business, and any proceeds from any Intellectual Property Sale, but would include our share of the net profits from the commercialization of cobimetinib in the U.S. and the receipt of royalties from cobimetinib sales outside the U.S., if any. |
Fair Value Measurements |
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Fair Value Disclosures [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fair Value Measurements | FAIR VALUE MEASUREMENTS Financial Assets Measured on a Recurring Basis The following table sets forth the fair value of our financial assets that were measured and recorded on a recurring basis as of September 30, 2016 and December 31, 2015. We did not have any Level 3 investments as of September 30, 2016 or December 31, 2015. The amounts presented exclude cash, but include investments classified as cash equivalents (in thousands):
The estimated fair value of our financial instruments that are carried at amortized cost is as follows (in thousands):
The carrying amounts of cash, trade and other receivables, accounts payable, accrued clinical trial liabilities, accrued compensation and benefits, accrued collaboration liability, and other accrued liabilities approximate their fair values and are excluded from the tables above. The following methods and assumptions were used to estimate the fair value of each class of financial instrument:
Financial Assets, Liabilities and Equity Measured on a Nonrecurring Basis In connection with the conversions for our 2019 Note during the three months ended September 30, 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:
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Stock-Based Compensation |
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Share-based Compensation [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stock-Based Compensation | STOCK-BASED COMPENSATION We recorded and allocated employee stock-based compensation expense for our equity incentive plans and our 2000 Employee Stock Purchase Plan (“ESPP”) as follows (in thousands):
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:
The fair value of employee stock option awards and ESPP purchases was estimated using the following assumptions:
The expected life computation is based on historical exercise patterns and post-vesting termination behavior. We considered implied volatility as well as our historical volatility in developing our estimate of expected volatility. A summary of all stock option activity for the nine months ended September 30, 2016 is presented below (dollars in thousands, except per share amounts):
As of September 30, 2016, a total of 574,885 shares were available for grant under our stock option plans. As of September 30, 2016, we had $22.9 million of unrecognized compensation expense related to employee stock options that is expected to be recognized over a weighted-average period of 3.01 years. On March 7, 2016, as a result of the FDA acceptance of our New Drug Application “NDA” submission and on April 28, 2016, as a result of the FDA’s approval of our NDA submission, the Compensation Committee of the Board of Directors of Exelixis convened to determine we had met certain performance objectives related to performance-based stock options granted to employees in 2014 and 2015. As a result of these determinations, 5,870,303 performance-based stock options vested during the nine months ended September 30, 2016 and we recorded an additional $4.1 million in stock-based compensation expense during the period related to those options. During 2015, we recorded $3.3 million in employee stock-based compensation expense related to those options. A summary of all restricted stock unit (“RSU”) activity for the nine months ended September 30, 2016 is presented below (dollars in thousands, except per share amounts):
As of September 30, 2016, we had $13.9 million of unrecognized compensation expense related to employee RSUs that is expected to be recognized over a weighted-average period of 3.30 years. During the nine months ended September 30, 2016, we made a bonus payment to our employees in the form of 1,072,833 shares of fully-vested restricted stock units which had a grant date fair value of $4.5 million. |
Net Loss Per Share |
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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):
The following table sets forth potentially dilutive shares of common stock that are not included in the computation of diluted net loss per share because to do so would be anti-dilutive (in thousands):
The warrants are participating securities and the warrant holders do not have a contractual obligation to share in our losses. |
Concentrations of Credit Risk |
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Risks and Uncertainties [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Concentrations of Credit Risk | CONCENTRATIONS OF CREDIT RISK Financial instruments that potentially subject us to concentrations of credit risk are primarily trade and other receivables and investments. Investments consist of money market funds, taxable commercial paper, corporate bonds with high credit quality, U.S. Treasury and government sponsored enterprises, and municipal bonds. All investments are maintained with financial institutions that management believes are creditworthy. Trade and other receivables are unsecured and are concentrated in the pharmaceutical and biotechnology industries. Accordingly, we may be exposed to credit risk generally associated with pharmaceutical and biotechnology companies. We have incurred no bad debt expense since inception. As of September 30, 2016, 38%, 17%, 12% and 10% of our trade receivables are with Diplomat Specialty Pharmacy, Caremark L.L.C., Accredo Health, Incorporated and affiliates of McKesson Corporation, respectively. All of these customers pay promptly. As of September 30, 2016, we had also had other receivables for milestone payments totaling $60.0 million due from Ipsen and $15.0 million due from Daiichi Sankyo. We received the full amount due from Daiichi Sankyo subsequent to September 30, 2016 and expect to receive the payment from Ipsen in mid-November 2016 in accordance with the terms of our collaboration and license agreement with Ipsen. All of our long-lived assets are located in the United States. We have operations primarily in the United States, while some of our collaboration partners have headquarters outside of the United States and some of our clinical trials for cabozantinib are also conducted outside of the United States. The following table shows the percentage of revenues earned in the United States and Europe:
The following table sets forth the percentage of revenues recognized by customer that represent 10% or more of total revenues:
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Organization and Summary of Significant Accounting Policies (Policies) |
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Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization | Organization Exelixis, Inc. (“Exelixis,” “we,” “our” or “us”) is a biopharmaceutical company committed to the discovery, development and commercialization of new medicines that will improve care and outcomes for people with cancer. Since its founding in 1994, three products discovered at Exelixis have progressed through clinical development, received regulatory approval, and entered the commercial marketplace. This portfolio includes two products derived from cabozantinib, an inhibitor of multiple tyrosine kinases including MET, AXL, and VEGF receptors. They are CABOMETYX™ tablets for the treatment of advanced kidney cancer and COMETRIQ® capsules for the treatment of certain forms of thyroid cancer, each approved both in the United States and European Union. The third product is COTELLIC®, a product derived from cobimetinib, a selective inhibitor of MEK, marketed under a collaboration with Roche and Genentech (a member of the Roche Group) that has been approved in combination with ZELBORAF® (vemurafenib) to treat advanced melanoma in several major territories, including the United States and European Union. |
Basis of Consolidation | Basis of Consolidation The condensed consolidated financial statements include the accounts of Exelixis and those of our wholly-owned subsidiaries. These entities’ functional currency is the U.S. dollar. All intercompany balances and transactions have been eliminated. |
Basis of Presentation | Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States for interim financial information and pursuant to Form 10-Q and Article 10 of Regulation S-X of the Securities and Exchange Commission (“SEC”). Accordingly, they do not include all of the information and footnotes required by U.S. generally accepted accounting principles for complete financial statements. In our opinion, all adjustments (consisting only of normal recurring adjustments) considered necessary for a fair presentation of the results of operations and cash flows for the periods presented have been included. |
Fiscal Period | We adopted a 52- or 53-week fiscal year that generally ends on the Friday closest to December 31st. Fiscal year 2016 will end on December 30, 2016, and fiscal year 2015, ended on January 1, 2016. For convenience, references in this report as of and for the fiscal periods ended September 30, 2016, and October 2, 2015, and as of and for the fiscal years ended December 30, 2016 and January 1, 2016, are indicated as being as of and for the periods ended September 30, 2016, September 30, 2015, and the years ended December 31, 2016, and December 31, 2015, respectively. |
Segment Information | Segment Information We operate as a single reportable segment. |
Use of Estimates | Use of Estimates The preparation of our consolidated financial statements is in conformity with accounting principles generally accepted in the United States that requires management to make judgments, estimates and assumptions that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosures. On an ongoing basis, management evaluates its estimates including, but not limited to, those related to revenue recognition, including for deductions from revenues (such as rebates, chargebacks, sales returns and sales allowances) and the period of performance, identification of deliverables and evaluation of milestones with respect to our collaborations, recoverability of inventory, certain accrued liabilities including clinical trial and collaboration liability accruals, the valuation of the debt and equity components of our convertible debt and share-based compensation. We base our estimates on historical experience and on various other market-specific and other relevant assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results could differ materially from those estimates. |
Revenue Recognition | Revenue Recognition We recognize revenue from product sales and from license fees, milestones, contingent payments and royalties earned on research, collaboration and license arrangements. See “Note 1 - Organization and Summary of Significant Accounting Policies” to our Consolidated Financial Statements included in our Annual Report on Form 10-K for the year ended December 31, 2015 for a description of our revenue recognition policies for product sales discounts and allowances, license and contract revenues under our collaboration agreement with Genentech and our Patient Assistance Program. Net Product Revenues We recognize revenue when it is both realized or realizable and earned, meaning persuasive evidence of an arrangement exists, delivery has occurred, title has transferred, the price is fixed or determinable, there are no remaining customer acceptance requirements, and collectability of the resulting receivable is reasonably assured. For product sales in the United States, this generally occurs upon delivery of the product to a specialty pharmacy or distributor. For product sales to our distribution partner, Swedish Orphan Biovitrum (“Sobi”), this generally occurs when Sobi has accepted the product. For product sales to our collaboration partner Ipsen, this generally occurs upon delivery. In the United States, we sell our products, CABOMETYX and COMETRIQ, to specialty pharmacies and distributors that benefit from customer incentives and have a right of return 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 payors at the time of shipment to the specialty pharmacy. Accordingly, beginning in January 2015 we began to recognize revenue upon delivery to the specialty pharmacy. This approach is frequently referred to as the “sell-in” revenue recognition model. In connection with the change in the timing of recognition of U.S. COMETRIQ sales, we recorded a one-time adjustment to recognize revenue that had previously been deferred under the “sell-through” revenue recognition model, resulting in the additional recognition of gross product revenues of $2.6 million for the nine months ended September 30, 2015; there were no such additional amounts recorded during the comparable period in 2016. In determining discounts and allowances for the initial launch and sale of CABOMETYX, in addition to using payer data received from the specialty pharmacies and distributors that sell CABOMETYX and historical data for COMETRIQ, we also utilized claims data from third party sources for competitor products for the treatment of advanced 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 nine months ended September 30, 2016 were impacted by the build of channel inventory related to the initial launch period for CABOMETYX. We also utilize the “sell-in” revenue recognition model for product sales to Sobi for all periods presented. Once Sobi has accepted the product, the product is generally no longer subject to return; therefore, we record revenue at the time Sobi has accepted the product. As described further in “Note 2 - Research and Collaboration Agreements”, under the terms of our collaboration and license agreement with Ipsen for the commercialization and further development of cabozantinib, we provided Sobi with a notice of termination of our commercialization agreement for COMETRIQ which will become effective November 1, 2016. We expect to repurchase the remaining product on hand from Sobi following the termination. As of September 30, 2016, we recorded allowances for expected future returns totaling $0.4 million; there were no such allowances recorded as of December 31, 2015 or September 30, 2015. For product sales to Ipsen, which began during the three months ended September 30, 2016, we utilize the “sell-in” revenue recognition model. Once title has transferred to Ipsen, the product is generally no longer subject to return; therefore, we record revenue at the time product is delivered. Royalty, License and Contract Revenues We enter into corporate collaboration and license agreements under which we may obtain upfront license fees, research funding, and contingent, milestone and royalty payments. These arrangements have multiple elements and our deliverables may include intellectual property rights, distribution rights, delivery of manufactured product, 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 continued involvement. Amounts received in advance of performance are recorded as deferred revenue. Upfront fees are classified as license revenues in our consolidated statements of operations. We consider sales-based contingent payments to be royalty revenue which is generally recognized at the date the contingency is achieved. Royalties are recorded based on sales amounts reported to us for the preceding quarter. For certain contingent payments under collaboration and license arrangements, we recognize revenue using the milestone method. Under the milestone method a payment that is contingent upon the achievement of a substantive milestone is recognized in its entirety in the period in which the milestone is achieved. A milestone is an event: (i) that can be achieved based in whole or in part on either our performance or on the occurrence of a specific outcome resulting from our performance, (ii) for which there is substantive uncertainty at the date the arrangement is entered into that the event will be achieved and (iii) that would result in additional payments being due to us. The determination that a milestone is substantive requires estimation and judgment and is made at the inception of the arrangement. Milestones are considered substantive when the consideration earned from the achievement of the milestone is: (i) commensurate with either our performance to achieve the milestone or the enhancement of value of the item delivered as a result of a specific outcome resulting from our performance to achieve the milestone, (ii) relates solely to past performance and (iii) reasonable relative to all deliverables and payment terms in the arrangement. In making the determination as to whether a milestone is substantive or not, we consider all facts and circumstances relevant to the arrangement, including factors such as the scientific, regulatory, commercial and other risks that must be overcome to achieve the respective milestone, the level of effort and investment required to achieve the respective milestone and whether any portion of the milestone consideration is related to future performance or deliverables. |
Recently Accounting Pronouncements | Recent Accounting Pronouncements In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Updates (“ASU”) No. 2014-09, Revenue from Contracts with Customers, (“ASU 2014-09”). ASU 2014-09 will replace most existing revenue recognition guidance when it becomes effective and permits the use of either the retrospective or cumulative effect transition method. In August 2015, the FASB issued an update to defer the effective date of this update 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 if we so choose. We currently plan to adopt this accounting standard in the first quarter of fiscal year 2018. We have not yet selected a transition method and are evaluating the effect that ASU 2014-09 will have on our Consolidated Financial Statements and related disclosures. In April 2015, the FASB issued Accounting Standards Update No. 2015-05, Customer’s Accounting for Fees Paid in a Cloud Computing Arrangement, (“ASU 2015-05”). ASU 2015-05 provides guidance to customers about whether a cloud computing arrangement includes a software license. If a cloud computing arrangement includes a software license, then the customer should account for the software license element of the arrangement consistent with the acquisition of other software licenses. If a cloud computing arrangement does not include a software license, the customer should account for the arrangement as a service contract. ASU 2015-05 was effective for all interim and annual reporting periods beginning after December 15, 2015 and therefore we adopted ASU 2015-05 in the three months ended March 31, 2016 on a prospective basis. The adoption of ASU 2015-05 did not have a material impact on our Condensed Consolidated Statements of Operations during the period of adoption and is not expected to have a material effect on our Consolidated Financial Statements in future periods. 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 are 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 condensed consolidated financial statements. In March 2016, the FASB issued Accounting Standards Update No. 2016-09, Improvements to Employee Share-Based Payment Accounting, (“ASU 2016-09”). ASU 2016-09 is aimed at the simplification of several aspects of the accounting for employee share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities, and classification on the statement of cash flows. ASU 2016-09 is effective for all interim and annual reporting periods beginning after December 15, 2016. Early adoption is permitted. We 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 Accounting Standards Update No. 2016-15, Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments, (“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. We do not expect the adoption of ASU 2016-15 to have a material impact on our Consolidated Statements of Cash Flows. |
Organization and Summary of Significant Accounting Policies (Tables) |
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Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Error Corrections and Prior Period Adjustments | 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:
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:
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Restructurings (Tables) |
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Restructuring Charges [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary Of Components Of Restructuring Liability | The changes of these liabilities during the nine months ended September 30, 2016, which related primarily to facilities, are summarized in the following table (in thousands):
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Cash and Investments (Tables) |
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Investments, Debt and Equity Securities [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Available-for-Sale Securities | The following tables summarize cash and cash equivalents, investments, and restricted cash and investments by balance sheet line item as of September 30, 2016 and December 31, 2015 (in thousands):
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Summary of Cash and Investments by Security Type | The amounts presented exclude cash, but include investments classified as cash equivalents (in thousands):
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Summary of Available-for-Sale Securities by Contractual Maturity | The following table summarizes the fair value of securities classified as available-for-sale by contractual maturity as of September 30, 2016 (in thousands):
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Inventory (Tables) |
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Inventory Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Inventory | Inventory consists of the following (in thousands):
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Debt (Tables) |
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Debt Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule Of Debt | The amortized carrying amount of our debt consists of the following (in thousands):
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Summary Of The Liability Component Notes | The following is a summary of the liability component of the 2019 Notes (in thousands):
The following is a summary of the interest expense for the 2019 Notes (in thousands):
The following is a summary of the interest expense for the Deerfield Notes (in thousands):
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Fair Value Measurements (Tables) |
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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):
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Schedule Of Estimated Fair Value Of Outstanding Debt | The estimated fair value of our financial instruments that are carried at amortized cost is as follows (in thousands):
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Stock-Based Compensation (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Sep. 30, 2016 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Share-based Compensation [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule Of Allocated Employee Stock-Based Compensation Expenses | We recorded and allocated employee stock-based compensation expense for our equity incentive plans and our 2000 Employee Stock Purchase Plan (“ESPP”) as follows (in thousands):
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Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value | We use the Black-Scholes Merton option pricing model to value our stock options. The weighted average grant-date fair value of our stock options and ESPP purchases was as follows:
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Schedule Of Fair Value Of Employee Share-Based Payments Awards Estimated Using The Assumptions And Weighted Average Fair Values | The fair value of employee stock option awards and ESPP purchases was estimated using the following assumptions:
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Summary Of All Stock Option Activity | A summary of all stock option activity for the nine months ended September 30, 2016 is presented below (dollars in thousands, except per share amounts):
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Summary Of All RSU Activity | A summary of all restricted stock unit (“RSU”) activity for the nine months ended September 30, 2016 is presented below (dollars in thousands, except per share amounts):
|
Net Loss Per Share (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Sep. 30, 2016 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Earnings Per Share [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule Of Reconciliation Of Basic And Diluted Net Income (Loss) Per Share | The following table sets forth a reconciliation of basic and diluted net loss per share (in thousands, except per share amounts):
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Schedule Of Potential Shares Of Common Stock Not Included In Computation Of Diluted Net Loss Per Share | The following table sets forth potentially dilutive shares of common stock that are not included in the computation of diluted net loss per share because to do so would be anti-dilutive (in thousands):
|
Concentrations of Credit Risk (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Sep. 30, 2016 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Risks and Uncertainties [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedules of concentration risk | The following table sets forth the percentage of revenues recognized by customer that represent 10% or more of total revenues:
The following table shows the percentage of revenues earned in the United States and Europe:
|
Organization and Summary of Significant Accounting Policies (Details) |
3 Months Ended | 9 Months Ended | 12 Months Ended | 45 Months Ended | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Apr. 25, 2016 |
Sep. 30, 2016
USD ($)
|
Sep. 30, 2015
USD ($)
|
Sep. 30, 2016
USD ($)
segment
|
Sep. 30, 2015
USD ($)
|
Dec. 31, 2015
USD ($)
|
Dec. 31, 2014
USD ($)
|
Dec. 31, 2013
USD ($)
|
Dec. 31, 2012
USD ($)
|
Sep. 30, 2016
USD ($)
|
Aug. 31, 2012
USD ($)
|
||||
Operations [Line Items] | ||||||||||||||
Number of operating segments | segment | 1 | |||||||||||||
Net income (loss) | $ (11,284,000) | $ (45,542,000) | $ (105,345,000) | $ (120,176,000) | $ (161,744,000) | $ (261,297,000) | $ (238,192,000) | $ (145,335,000) | ||||||
Retained earnings (accumulated deficit) | (2,018,270,000) | (2,018,270,000) | (1,912,925,000) | [1] | $ (1,751,180,000) | $ (1,489,883,000) | $ (1,251,692,000) | $ (2,018,270,000) | ||||||
Net product revenues | 42,742,000 | 6,854,000 | 83,459,000 | 24,234,000 | 157,700,000 | |||||||||
Shipping period for newly approved product, upon initial approval | 3 days | |||||||||||||
Cash and investments | 379,648,000 | 379,648,000 | 253,310,000 | 379,648,000 | ||||||||||
Cash and investments available for operations | 293,800,000 | 293,800,000 | 293,800,000 | |||||||||||
Compensating balance investments | 81,600,000 | 81,600,000 | 81,600,000 | |||||||||||
Long-term restricted cash and investments | 4,150,000 | 4,150,000 | 2,650,000 | [1] | 4,150,000 | |||||||||
Reserve for returns and repurchase of unsold product | 400,000 | 0 | 400,000 | 0 | 0 | 400,000 | ||||||||
“Sell-In” Revenue Recognition Model [Member] | ||||||||||||||
Operations [Line Items] | ||||||||||||||
Net product revenues | 0 | $ 0 | 0 | $ 2,600,000 | ||||||||||
Senior Subordinated Notes [Member] | Convertible Senior Subordinated Notes due 2019 [Member] | ||||||||||||||
Operations [Line Items] | ||||||||||||||
Debt, principal amount | $ 2,192,000 | $ 2,192,000 | $ 287,500,000 | $ 2,192,000 | $ 287,500,000.0 | |||||||||
Debt, interest rate (as a percent) | 4.25% | |||||||||||||
|
Organization and Summary of Significant Accounting Policies (Correction of Immaterial Error Impact on Comprehensive Income) (Details) - USD ($) $ / shares in Units, $ in Thousands |
3 Months Ended | 9 Months Ended | 12 Months Ended | |||||
---|---|---|---|---|---|---|---|---|
Sep. 30, 2016 |
Sep. 30, 2015 |
Sep. 30, 2016 |
Sep. 30, 2015 |
Dec. 31, 2015 |
Dec. 31, 2014 |
Dec. 31, 2013 |
Dec. 31, 2012 |
|
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||||||||
Interest expense | $ (7,834) | $ (10,037) | $ (28,575) | $ (30,501) | $ (40,680) | $ (41,362) | $ (38,779) | $ (24,778) |
Total other income (expense), net | (18,548) | (9,761) | (38,338) | (30,355) | (40,268) | (37,021) | (37,556) | (22,792) |
Net loss | $ (11,284) | $ (45,542) | $ (105,345) | $ (120,176) | $ (161,744) | $ (261,297) | $ (238,192) | $ (145,335) |
Net loss per share, basic and diluted, in dollars per share | $ (0.04) | $ (0.21) | $ (0.44) | $ (0.59) | $ (0.77) | $ (1.34) | $ (1.29) | $ (0.91) |
Comprehensive loss | $ (11,493) | $ (45,409) | $ (105,193) | $ (120,096) | $ (161,855) | $ (261,564) | $ (237,954) | $ (145,289) |
Accretion of debt discount and debt issuance costs | $ 8,295 | 14,274 | 17,041 | 22,289 | 19,722 | 12,442 | ||
Revision Adjustment [Member] | ||||||||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||||||||
Interest expense | 2,022 | 5,920 | 7,993 | 7,245 | 6,568 | 2,310 | ||
Total other income (expense), net | 2,022 | 5,920 | 7,993 | 7,245 | 6,568 | 2,310 | ||
Net loss | $ 2,022 | $ 5,920 | $ 7,993 | $ 7,245 | $ 6,568 | $ 2,310 | ||
Net loss per share, basic and diluted, in dollars per share | $ 0.01 | $ 0.03 | $ 0.04 | $ 0.04 | $ 0.04 | $ 0.01 | ||
Comprehensive loss | $ 2,022 | $ 5,920 | $ 7,993 | $ 7,245 | $ 6,568 | $ 2,310 | ||
Accretion of debt discount and debt issuance costs | $ (5,920) | $ (7,993) | $ (7,245) | $ (6,568) | $ (2,310) |
Organization and Summary of Significant Accounting Policies (Correction of Immaterial Error Impact on Balance Sheet and Stockholders' Equity) (Details) - USD ($) $ in Thousands |
3 Months Ended | 9 Months Ended | 12 Months Ended | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Sep. 30, 2016 |
Sep. 30, 2015 |
Sep. 30, 2016 |
Sep. 30, 2015 |
Dec. 31, 2015 |
Dec. 31, 2014 |
Dec. 31, 2013 |
Dec. 31, 2012 |
||||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | |||||||||||
Long-term portion of convertible notes | $ 81,493 | $ 81,493 | $ 337,937 | [1] | $ 223,629 | $ 301,550 | $ 291,828 | ||||
Liabilities | 516,468 | 516,468 | 473,148 | [1] | 482,592 | 483,452 | 476,015 | ||||
Additional paid-in capital | 2,050,086 | 2,050,086 | 1,772,123 | [1] | 1,591,782 | 1,504,052 | 1,489,727 | ||||
Accumulated deficit | (2,018,270) | (2,018,270) | (1,912,925) | [1] | (1,751,180) | (1,489,883) | (1,251,692) | ||||
Stockholders' (deficit) equity | 32,022 | 32,022 | (140,806) | [1] | (159,323) | 14,499 | 238,127 | ||||
Net loss | $ (11,284) | $ (45,542) | $ (105,345) | $ (120,176) | (161,744) | (261,297) | (238,192) | (145,335) | |||
Revision Adjustment [Member] | |||||||||||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | |||||||||||
Long-term portion of convertible notes | 36,502 | 44,494 | 51,739 | 58,307 | |||||||
Liabilities | 36,502 | 44,494 | 51,739 | 58,307 | |||||||
Additional paid-in capital | (60,618) | (60,618) | (60,618) | (60,618) | |||||||
Accumulated deficit | 24,116 | 16,124 | 8,879 | 2,310 | |||||||
Stockholders' (deficit) equity | (36,502) | (44,494) | (51,739) | (58,307) | |||||||
Net loss | $ 2,022 | $ 5,920 | $ 7,993 | $ 7,245 | $ 6,568 | $ 2,310 | |||||
|
Research and Collaboration Agreements (Ipsen Collaboration) (Details) |
1 Months Ended | 3 Months Ended | 9 Months Ended | ||||||
---|---|---|---|---|---|---|---|---|---|
Feb. 29, 2016
USD ($)
payment
country
|
Mar. 31, 2016
USD ($)
|
Sep. 30, 2016
USD ($)
|
Sep. 30, 2016
USD ($)
|
Dec. 31, 2015
USD ($)
|
Sep. 30, 2015
USD ($)
|
||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Current portion of deferred revenue | $ 18,939,000 | $ 18,939,000 | $ 0 | [1] | |||||
Long-term portion of deferred revenue | 232,573,000 | 232,573,000 | 0 | [1] | |||||
Reserve for returns and repurchase of unsold product | 400,000 | 400,000 | $ 0 | $ 0 | |||||
Ipsen [Member] | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Upfront and milestone payments | $ 200,000,000 | ||||||||
Eligible payment from collaboration for development and regulatory milestone achievement Under Collaborations Agreement | $ 240,000,000 | ||||||||
Maximum amount eligible for commercial milestones under collaborations agreement | $ 525,000,000 | ||||||||
Research and development arrangement performed for others, reimbursement for costs incurred (as a percent) | 35.00% | ||||||||
License and contract revenue | 3,800,000 | 8,600,000 | |||||||
Current portion of deferred revenue | 18,900,000 | 18,900,000 | |||||||
Long-term portion of deferred revenue | 232,600,000 | 232,600,000 | |||||||
RCC [Member] | Ipsen [Member] | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Eligible payment from collaboration for development and regulatory milestone achievement Under Collaborations Agreement | $ 60,000,000 | ||||||||
HCC Filing [Member] | Ipsen [Member] | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Eligible payment from collaboration for development and regulatory milestone achievement Under Collaborations Agreement | 10,000,000 | ||||||||
HCC Acceptance [Member] | Ipsen [Member] | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Eligible payment from collaboration for development and regulatory milestone achievement Under Collaborations Agreement | $ 40,000,000 | ||||||||
EU Country Launch [Member] | Ipsen [Member] | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Number of payments to be received upon milestone achievement | payment | 2 | ||||||||
Maximum amount eligible for commercial milestones under collaborations agreement | $ 10,000,000 | ||||||||
Number of countries in which entity launches product | country | 2 | ||||||||
Initial [Member] | Ipsen [Member] | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Percent of royalty on net sale | 2.00% | ||||||||
Royalty tier | $ 50,000,000 | ||||||||
Second [Member] | Ipsen [Member] | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Percent of royalty on net sale | 12.00% | ||||||||
Royalty tier | $ 100,000,000 | ||||||||
Initial and second [Member] | Ipsen [Member] | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Royalty tier | $ 150,000,000.0 | ||||||||
Minimum [Member] | Ipsen [Member] | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Percent of royalty on net sale | 22.00% | ||||||||
Maximum [Member] | Ipsen [Member] | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Percent of royalty on net sale | 26.00% | ||||||||
Swedish Orphan Biovitrum [Member] | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Termination fee | 2,700,000 | 2,700,000 | |||||||
Reserve for returns and repurchase of unsold product | $ 400,000 | $ 400,000 | |||||||
|
Research and Collaboration Agreements (Genetech and Other Collaborations) (Details) - USD ($) |
1 Months Ended | 3 Months Ended | 9 Months Ended | ||||
---|---|---|---|---|---|---|---|
Nov. 30, 2015 |
Jan. 31, 2007 |
Dec. 31, 2006 |
Sep. 30, 2016 |
Sep. 30, 2015 |
Sep. 30, 2016 |
Sep. 30, 2015 |
|
Genentech [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Upfront and milestone payments | $ 15,000,000.0 | $ 25,000,000 | |||||
Profit sharing agreement, percent of total sales force | 25.00% | ||||||
License and contract revenue | $ 700,000 | $ 0 | $ 1,800,000 | $ 0 | |||
Profit Sharing Tier One [Member] | Genentech [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Profit sharing agreement (as a percent of profits) | 50.00% | ||||||
Profit sharing agreement, profit threshold | $ 200,000,000 | ||||||
Profit Sharing Tier Two [Member] | Genentech [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Profit sharing agreement (as a percent of profits) | 30.00% | ||||||
Profit sharing agreement, profit threshold | $ 400,000,000 | ||||||
Selling, general and administrative expense [Member] | Genentech [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Collaborative arrangement, income (loss) from agreement | (2,900,000) | (4,300,000) | (14,800,000) | (11,800,000) | |||
Daiichi Sankyo [Member] | Other Collaborative Arrangement [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Contract revenues from contingent payments earned | $ 15,000,000 | 15,000,000 | |||||
Merck [Member] | Other Collaborative Arrangement [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Contract revenues from contingent payments earned | $ 3,000,000 | $ 5,000,000 | $ 3,000,000 |
Restructurings (Narrative) (Details) $ in Thousands |
3 Months Ended | 9 Months Ended | 39 Months Ended | |||
---|---|---|---|---|---|---|
Sep. 30, 2016
USD ($)
|
Sep. 30, 2015
USD ($)
|
Sep. 30, 2016
USD ($)
|
Sep. 30, 2015
USD ($)
|
May 31, 2013
restructuring
|
Dec. 31, 2015
USD ($)
|
|
Restructuring Cost and Reserve [Line Items] | ||||||
Restructuring (recovery) charge | $ (244) | $ 282 | $ 871 | $ 1,142 | ||
Restructuring reserve | 2,225 | 2,225 | $ 4,590 | |||
Expected additional restructuring costs to be incurred | 100 | 100 | ||||
Facility Closing [Member] | ||||||
Restructuring Cost and Reserve [Line Items] | ||||||
Restructuring (recovery) charge | 800 | 1,500 | ||||
Recovery related to sublease | (100) | |||||
Recoveries related to sale of buildings | $ (900) | |||||
2010 Restructurings [Member] | ||||||
Restructuring Cost and Reserve [Line Items] | ||||||
Number of restructurings implemented | restructuring | 5 | |||||
Restructuring (recovery) charge | 862 | |||||
Restructuring reserve | $ 2,150 | $ 2,150 | $ 4,087 |
Restructurings (Summary of Components of Restructuring Liability) (Details) - USD ($) $ in Thousands |
3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Sep. 30, 2016 |
Sep. 30, 2015 |
Sep. 30, 2016 |
Sep. 30, 2015 |
|
Restructuring Reserve [Roll Forward] | ||||
Restructuring liability, beginning balance | $ 4,590 | |||
Restructuring charge | $ (244) | $ 282 | 871 | $ 1,142 |
Proceeds from sale of assets | 34 | |||
Cash payments, net | (4,211) | |||
Other items | 941 | |||
Restructuring liability, ending balance | 2,225 | 2,225 | ||
2010 Restructurings [Member] | ||||
Restructuring Reserve [Roll Forward] | ||||
Restructuring liability, beginning balance | 4,087 | |||
Restructuring charge | 862 | |||
Proceeds from sale of assets | 0 | |||
Cash payments, net | (3,774) | |||
Other items | 975 | |||
Restructuring liability, ending balance | 2,150 | 2,150 | ||
2014 Restructuring [Member] | ||||
Restructuring Reserve [Roll Forward] | ||||
Restructuring liability, beginning balance | 503 | |||
Restructuring charge | 9 | |||
Proceeds from sale of assets | 34 | |||
Cash payments, net | (437) | |||
Other items | (34) | |||
Restructuring liability, ending balance | $ 75 | $ 75 |
Cash and Investments (Details) |
9 Months Ended | ||
---|---|---|---|
Sep. 30, 2016
USD ($)
account
investment
affiliate
|
Sep. 30, 2015
USD ($)
|
Dec. 31, 2015
USD ($)
|
|
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | $ 379,621,000 | $ 253,433,000 | |
Gross Unrealized Gains | 98,000 | 7,000 | |
Gross Unrealized Losses | (71,000) | (130,000) | |
Fair Value | $ 379,648,000 | 253,310,000 | |
Debt collateral, number of required investment accounts | account | 1 | ||
Debt collateral, number of affiliate banks | affiliate | 1 | ||
Amortized Cost | $ 366,031,000 | 250,810,000 | |
Gross Unrealized Gains | 98,000 | 7,000 | |
Gross Unrealized Losses | (71,000) | (130,000) | |
Fair Value | 366,058,000 | 250,687,000 | |
Other than temporary impairment losses, available-for-sale securities | $ 0 | $ 0 | |
Number of investments in an unrealized loss position, less than 1 year | investment | 37 | ||
Unrealized loss position, less than 1 year | $ (71,000) | ||
Unrealized loss position, less than 1 year, fair value | 67,300,000 | ||
Mature within One Year | 310,241,000 | ||
After One Year through Two Years | 55,817,000 | ||
Fair Value | 366,058,000 | 250,687,000 | |
Money market funds [Member] | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 47,148,000 | 72,000,000 | |
Gross Unrealized Gains | 0 | 0 | |
Gross Unrealized Losses | 0 | 0 | |
Fair Value | 47,148,000 | 72,000,000 | |
Mature within One Year | 47,148,000 | ||
After One Year through Two Years | 0 | ||
Fair Value | 47,148,000 | 72,000,000 | |
Commercial paper [Member] | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 133,309,000 | 78,155,000 | |
Gross Unrealized Gains | 0 | 0 | |
Gross Unrealized Losses | 0 | 0 | |
Fair Value | 133,309,000 | 78,155,000 | |
Mature within One Year | 133,309,000 | ||
After One Year through Two Years | 0 | ||
Fair Value | 133,309,000 | 78,155,000 | |
Corporate bonds [Member] | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 124,346,000 | 72,205,000 | |
Gross Unrealized Gains | 44,000 | 4,000 | |
Gross Unrealized Losses | (67,000) | (118,000) | |
Fair Value | 124,323,000 | 72,091,000 | |
Mature within One Year | 74,661,000 | ||
After One Year through Two Years | 49,662,000 | ||
Fair Value | 124,323,000 | 72,091,000 | |
U.S. Treasury and government sponsored enterprises [Member] | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 61,228,000 | 28,434,000 | |
Gross Unrealized Gains | 54,000 | 1,000 | |
Gross Unrealized Losses | (4,000) | (12,000) | |
Fair Value | 61,278,000 | 28,423,000 | |
Mature within One Year | 55,123,000 | ||
After One Year through Two Years | 6,155,000 | ||
Fair Value | 61,278,000 | 28,423,000 | |
Marketable equity securities [Member] | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 16,000 | ||
Gross Unrealized Gains | 2,000 | ||
Gross Unrealized Losses | 0 | ||
Fair Value | 18,000 | ||
Fair Value | 18,000 | ||
Silicon Valley Bank Loan And Security Agreement [Member] | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Collateral balance | 81,600,000 | 81,600,000 | |
Cash and cash equivalents [Member] | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 111,219,000 | 141,634,000 | |
Gross Unrealized Gains | 0 | 0 | |
Gross Unrealized Losses | 0 | 0 | |
Fair Value | 111,219,000 | 141,634,000 | |
Short-term investments [Member] | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 208,412,000 | 25,484,000 | |
Gross Unrealized Gains | 70,000 | 5,000 | |
Gross Unrealized Losses | (20,000) | (63,000) | |
Fair Value | 208,462,000 | 25,426,000 | |
Long-term investments [Member] | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 55,840,000 | 83,665,000 | |
Gross Unrealized Gains | 28,000 | 2,000 | |
Gross Unrealized Losses | (51,000) | (67,000) | |
Fair Value | 55,817,000 | 83,600,000 | |
Long-term restricted cash and investments [Member] | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 4,150,000 | 2,650,000 | |
Gross Unrealized Gains | 0 | 0 | |
Gross Unrealized Losses | 0 | 0 | |
Fair Value | $ 4,150,000 | $ 2,650,000 |
Inventory (Details) - USD ($) $ in Thousands |
3 Months Ended | 9 Months Ended | ||||||
---|---|---|---|---|---|---|---|---|
Sep. 30, 2016 |
Sep. 30, 2015 |
Sep. 30, 2016 |
Sep. 30, 2015 |
Dec. 31, 2015 |
||||
Inventory Disclosure [Abstract] | ||||||||
Raw materials | $ 890 | $ 890 | $ 1,037 | |||||
Work in process | 2,540 | 2,540 | 2,251 | |||||
Finished goods | 582 | 582 | 583 | |||||
Total | 4,012 | 4,012 | 3,871 | |||||
Less: non-current portion included in Other assets | (720) | (720) | (1,255) | |||||
Inventory | 3,292 | 3,292 | $ 2,616 | [1] | ||||
Inventory write-down | $ 400 | $ 1,100 | $ 400 | $ 900 | ||||
|
Debt (Schedule Of Debt) (Details) - USD ($) $ in Thousands |
Sep. 30, 2016 |
Dec. 31, 2015 |
---|---|---|
Debt Instrument [Line Items] | ||
Total debt | $ 190,858 | $ 417,937 |
Less: current portion | (109,365) | 0 |
Long-term debt | 81,493 | 417,937 |
Senior Subordinated Notes [Member] | Convertible Senior Subordinated Notes due 2019 [Member] | ||
Debt Instrument [Line Items] | ||
Convertible Debt | 1,865 | 235,210 |
Secured Debt [Member] | Secured Convertible Notes due 2018 [Member] | ||
Debt Instrument [Line Items] | ||
Convertible Debt | 108,993 | 102,727 |
Term Loan [Member] | ||
Debt Instrument [Line Items] | ||
Term loan payable | $ 80,000 | $ 80,000 |
Debt (Convertible Notes) (Details) - USD ($) |
3 Months Ended | 9 Months Ended | 12 Months Ended | ||||||
---|---|---|---|---|---|---|---|---|---|
Sep. 30, 2016 |
Sep. 30, 2015 |
Sep. 30, 2016 |
Sep. 30, 2015 |
Dec. 31, 2015 |
Dec. 31, 2014 |
Dec. 31, 2013 |
Dec. 31, 2012 |
Aug. 31, 2012 |
|
Debt Instrument [Line Items] | |||||||||
Amortization of debt discount and debt issuance costs | $ 8,295,000 | $ 14,274,000 | $ 17,041,000 | $ 22,289,000 | $ 19,722,000 | $ 12,442,000 | |||
Senior Subordinated Notes [Member] | Convertible Senior Subordinated Notes due 2019 [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Net carrying amount of the liability component | $ 1,865,000 | 1,865,000 | 235,210,000 | ||||||
Unamortized discount of the liability component | 327,000 | 327,000 | 52,290,000 | ||||||
Face amount of the 2019 Notes | 2,192,000 | 2,192,000 | 287,500,000 | $ 287,500,000.0 | |||||
Stated coupon interest | 1,683,000 | $ 3,054,000 | 7,793,000 | 9,164,000 | |||||
Amortization of debt discount and debt issuance costs | 1,763,000 | 2,929,000 | 7,968,000 | 8,585,000 | |||||
Total interest expense | 3,446,000 | 5,983,000 | 15,761,000 | 17,749,000 | |||||
Secured Convertible Notes due 2018 [Member] | Deerfield Financing [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Net carrying amount of the liability component | 109,800,000 | 109,800,000 | $ 103,800,000 | ||||||
Stated coupon interest | 2,031,000 | 1,891,000 | 5,939,000 | 4,866,000 | |||||
Amortization of debt discount and debt issuance costs | 2,152,000 | 1,959,000 | 6,266,000 | 7,279,000 | |||||
Total interest expense | $ 4,183,000 | $ 3,850,000 | $ 12,205,000 | $ 12,145,000 |
Debt (Narrative) (Details) - USD ($) |
1 Months Ended | 2 Months Ended | 3 Months Ended | 9 Months Ended | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Nov. 02, 2016 |
Aug. 19, 2016 |
Jul. 01, 2015 |
Sep. 30, 2016 |
Mar. 31, 2016 |
Jan. 31, 2015 |
Aug. 31, 2012 |
Sep. 30, 2016 |
Sep. 30, 2016 |
Sep. 30, 2015 |
Sep. 30, 2016 |
Sep. 30, 2015 |
Aug. 24, 2016 |
Dec. 31, 2015 |
|
Debt Instrument [Line Items] | ||||||||||||||
Debt conversion, aggregate principal amount converted | $ 285,308,000 | $ 0 | ||||||||||||
Loss on extinguishment of debt | $ 13,773,000 | $ 0 | 13,773,000 | $ 0 | ||||||||||
Ipsen [Member] | ||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||
Upfront and milestone payments | $ 200,000,000 | |||||||||||||
Senior Subordinated Notes [Member] | Convertible Senior Subordinated Notes due 2019 [Member] | ||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||
Debt, principal amount | $ 2,192,000 | $ 287,500,000.0 | $ 2,192,000 | 2,192,000 | $ 2,192,000 | $ 287,500,000 | ||||||||
Proceeds from issuance of convertible debt, net | $ 277,700,000 | |||||||||||||
Debt, interest rate (as a percent) | 4.25% | |||||||||||||
Debt conversion, aggregate principal amount converted | $ 239,400,000 | $ 45,900,000 | ||||||||||||
Debt conversion, shares issued to holders | 45,064,456 | 8,640,455 | 53,704,911 | |||||||||||
Induced conversion of convertible debt expense | $ (6,000,000) | |||||||||||||
Payments for inducements of debt conversion | (2,400,000) | |||||||||||||
Forgiveness of repayment of interest | $ (3,600,000) | |||||||||||||
Redemption of convertible debt, announced amount | $ 48,100,000 | |||||||||||||
Convertible debt conversion ratio | 188.2353 | |||||||||||||
Conversion ratio, principal amount | $ 1,000 | |||||||||||||
Increase to common stock and additional paid-in capital | $ 589,200,000 | |||||||||||||
Loss on extinguishment of debt | 7,300,000 | |||||||||||||
Adjustment to additional paid-in capital, reacquisition of embedded conversion option | 340,500,000 | |||||||||||||
Loss on extinguishment of debt, transaction costs | (500,000) | |||||||||||||
Adjustment to paid-in capital, transaction costs | 700,000 | |||||||||||||
Balance of unamortized closing fees and expenses | $ 26,000 | 26,000 | 26,000 | 26,000 | 4,200,000 | |||||||||
Convertible debt | 1,865,000 | 1,865,000 | 1,865,000 | 1,865,000 | 235,210,000 | |||||||||
Secured Convertible Notes Due June 2018 [Member] | Deerfield Financing [Member] | ||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||
Balance of unamortized closing fees and expenses | 500,000 | 500,000 | 500,000 | 500,000 | 700,000 | |||||||||
Convertible debt | $ 109,800,000 | $ 109,800,000 | $ 109,800,000 | $ 109,800,000 | $ 103,800,000 | |||||||||
Debt instrument, interest rate, stated percentage after extension option election | 15.00% | 15.00% | 15.00% | 15.00% | ||||||||||
Annual interest | $ 6,000,000 | |||||||||||||
Debt instrument, effective interest rate (as a percent) | 15.30% | 15.30% | 15.30% | 15.30% | ||||||||||
Percentage of revenue payable under collaborative arrangements | 15.00% | 15.00% | ||||||||||||
Maximum prepayment amount under collaborative arrangements | $ 27,500,000.0 | |||||||||||||
Mandatory prepayment under collaborative arrangement | $ 27,500,000 | |||||||||||||
Secured Convertible Notes Due June 2018 [Member] | Deerfield Financing [Member] | Coupon Interest [Member] | ||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||
Debt instrument, interest rate, stated percentage after extension option election | 7.50% | 7.50% | 7.50% | 7.50% | ||||||||||
Secured Convertible Notes Due June 2018 [Member] | Deerfield Financing [Member] | Payment-in-Kind Interest [Member] | ||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||
Debt instrument, interest rate, stated percentage after extension option election | 7.50% | 7.50% | 7.50% | 7.50% | ||||||||||
Scenario, Forecast [Member] | Senior Subordinated Notes [Member] | Convertible Senior Subordinated Notes due 2019 [Member] | ||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||
Redemption price (as a percent of principal) | 100.00% | |||||||||||||
Merck [Member] | Collaborative Arrangement [Member] | ||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||
Proceeds from achievement of collaboration arrangement milestone | $ 5,000,000.0 |
Fair Value Measurements (Schedule Of Fair Value Of Financial Assets Measured On A Recurring Basis) (Details) - USD ($) $ in Thousands |
Sep. 30, 2016 |
Dec. 31, 2015 |
---|---|---|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | $ 366,058 | $ 250,687 |
Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 47,148 | 72,018 |
Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 318,910 | 178,669 |
Money market funds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 47,148 | 72,000 |
Money market funds [Member] | Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 47,148 | 72,000 |
Money market funds [Member] | Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 0 | 0 |
Commercial paper [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 133,309 | 78,155 |
Commercial paper [Member] | Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 0 | 0 |
Commercial paper [Member] | Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 133,309 | 78,155 |
Corporate bonds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 124,323 | 72,091 |
Corporate bonds [Member] | Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 0 | 0 |
Corporate bonds [Member] | Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 124,323 | 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 | 61,278 | 28,423 |
U.S. Treasury and government sponsored enterprises [Member] | Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 0 | 0 |
U.S. Treasury and government sponsored enterprises [Member] | Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | $ 61,278 | 28,423 |
Marketable equity securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 18 | |
Marketable equity securities [Member] | Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 18 | |
Marketable equity securities [Member] | Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | $ 0 |
Fair Value Measurements (Schedule of Estimated Fair Value of Outstanding Debt) (Details) - USD ($) $ in Thousands |
Sep. 30, 2016 |
Dec. 31, 2015 |
---|---|---|
Carrying Amount [Member] | Senior Subordinated Notes [Member] | Convertible Senior Subordinated Notes due 2019 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair values of financial instruments | $ 1,865 | $ 235,210 |
Carrying Amount [Member] | Secured Convertible Notes Due June 2018 [Member] | Deerfield Financing [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair values of financial instruments | 108,993 | 102,727 |
Carrying Amount [Member] | Term Loan [Member] | Silicon Valley Bank term loan and Line of Credit [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair values of financial instruments | 80,000 | 80,000 |
Fair Value [Member] | Senior Subordinated Notes [Member] | Convertible Senior Subordinated Notes due 2019 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair values of financial instruments | 5,277 | 336,260 |
Fair Value [Member] | Secured Convertible Notes Due June 2018 [Member] | Deerfield Financing [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair values of financial instruments | 110,806 | 101,096 |
Fair Value [Member] | Term Loan [Member] | Silicon Valley Bank term loan and Line of Credit [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair values of financial instruments | $ 79,828 | $ 79,815 |
Fair Value Measurements (Schedule of Assumptions Used) (Details) |
9 Months Ended | |
---|---|---|
Sep. 30, 2016
USD ($)
|
Aug. 24, 2016
USD ($)
|
|
Convertible Senior Subordinated Notes due 2019 [Member] | Senior Subordinated Notes [Member] | ||
Fair Value Inputs, Liabilities, Quantitative Information [Line Items] | ||
Redemption of convertible debt, announced amount | $ 48,100,000 | |
Convertible debt conversion ratio | 188.2353 | |
Conversion ratio, principal amount | $ 1,000 | |
Deerfield Financing [Member] | Secured Convertible Notes Due June 2018 [Member] | Level 3 [Member] | ||
Fair Value Inputs, Liabilities, Quantitative Information [Line Items] | ||
Fair value inputs, discount rate (as a percent) | 15.00% | |
Discounted Cash Flows [Member] | Convertible Senior Subordinated Notes due 2019 [Member] | Level 3 [Member] | ||
Fair Value Inputs, Liabilities, Quantitative Information [Line Items] | ||
Fair value inputs, discount rate (as a percent) | 9.50% |
Stock-Based Compensation (Schedule of Allocated Employee Stock-Based Compensation Expenses) (Details) - USD ($) $ in Thousands |
3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Sep. 30, 2016 |
Sep. 30, 2015 |
Sep. 30, 2016 |
Sep. 30, 2015 |
|
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Total employee stock-based compensation expense | $ 3,603 | $ 12,026 | $ 18,346 | $ 15,420 |
Research and development expense [Member] | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Total employee stock-based compensation expense | 1,165 | 6,676 | 7,894 | 8,049 |
Selling, general and administrative expense [Member] | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Total employee stock-based compensation expense | $ 2,438 | $ 5,350 | $ 10,452 | $ 7,371 |
Stock-Based Compensation (Weighted Average Grant Date Fair Values) (Details) - $ / shares |
3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Sep. 30, 2016 |
Sep. 30, 2015 |
Sep. 30, 2016 |
Sep. 30, 2015 |
|
Stock Option [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Weighted average grant-date fair value (in dollars per share) | $ 8.59 | $ 3.92 | $ 4.31 | $ 2.51 |
ESPP [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Weighted average grant-date fair value (in dollars per share) | $ 1.51 | $ 1.26 | $ 1.65 | $ 0.97 |
Stock-Based Compensation (Schedule of Fair Value of Employee Share-Based Payments Awards Estimated Using the Assumptions) (Details) |
3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Sep. 30, 2016 |
Sep. 30, 2015 |
Sep. 30, 2016 |
Sep. 30, 2015 |
|
Stock Option [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Risk-free interest rate | 1.07% | 1.18% | 1.09% | 1.20% |
Dividend yield | 0.00% | 0.00% | 0.00% | 0.00% |
Volatility | 76.00% | 88.00% | 76.00% | 93.00% |
Expected life | 4 years 6 months 18 days | 4 years 7 months | 4 years 4 months 27 days | 4 years 6 months |
ESPP [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Risk-free interest rate | 0.37% | 0.06% | 0.39% | 0.09% |
Dividend yield | 0.00% | 0.00% | 0.00% | 0.00% |
Volatility | 63.00% | 107.00% | 66.00% | 101.00% |
Expected life | 6 months | 6 months | 6 months | 6 months |
Stock-Based Compensation (Summary of All Stock Option Activity) (Details) $ / shares in Units, $ in Thousands |
9 Months Ended |
---|---|
Sep. 30, 2016
USD ($)
$ / shares
shares
| |
Shares [Roll Forward] | |
Options outstanding at beginning of period, Shares | shares | 27,425,854 |
Granted, Shares | shares | 3,771,250 |
Exercised, Shares | shares | (3,360,248) |
Forfeited, Shares | shares | (307,601) |
Expired, Shares | shares | (80,516) |
Options outstanding at end of period, Shares | shares | 27,448,739 |
Exercisable at end of period, Shares | shares | 20,042,258 |
Weighted Average Exercise Price [Roll Forward] | |
Options outstanding at beginning of period, Weighted Average Exercise Price (in dollars per share) | $ / shares | $ 4.22 |
Granted, Weighted Average Exercise Price (in dollars per share) | $ / shares | 7.35 |
Exercised, Weighted Average Exercise Price (in dollars per share) | $ / shares | 2.81 |
Forfeited, Weighted Average Exercise Price (in dollars per share) | $ / shares | 4.67 |
Expired, Weighted Average Exercise Price (in dollars per share) | $ / shares | 10.49 |
Options outstanding at end of period, Weighted Average Exercise Price (in dollars per share) | $ / shares | 4.80 |
Exercisable at end of period, Weighted Average Exercise Price (in dollars per share) | $ / shares | $ 4.19 |
Options outstanding at end of period, Weighted Average Remaining Contractual Term | 4 years 6 months 29 days |
Exercisable at end of period, Weighted Average Remaining Contractual Term | 4 years 7 days |
Options outstanding at end of period, Aggregate Intrinsic Value, in dollars | $ | $ 221,332 |
Exercisable at end of period, Aggregate Intrinsic Value, in dollars | $ | $ 172,458 |
Stock-Based Compensation (Narrative) (Details) - USD ($) $ in Thousands |
3 Months Ended | 9 Months Ended | 12 Months Ended | ||
---|---|---|---|---|---|
Sep. 30, 2016 |
Sep. 30, 2015 |
Sep. 30, 2016 |
Sep. 30, 2015 |
Dec. 31, 2015 |
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock-based compensation expense allocated | $ 3,603 | $ 12,026 | $ 18,346 | $ 15,420 | |
Stock Option [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of shares available for grant | 574,885 | 574,885 | |||
Unrecognized compensation expense | $ 22,900 | $ 22,900 | |||
Unrecognized compensation expense, weighted-average period for recognition (in years) | 3 years 3 days | ||||
Performance Stock Options [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of stock options vested, in shares | 5,870,303 | ||||
Stock-based compensation expense allocated | $ 4,100 | $ 3,300 | |||
Restricted Stock Units (RSUs) [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Unrecognized compensation expense | $ 13,900 | $ 13,900 | |||
Unrecognized compensation expense, weighted-average period for recognition (in years) | 3 years 3 months 18 days |
Stock-Based Compensation (Summary of All RSU Activity) (Details) $ / shares in Units, $ in Thousands |
9 Months Ended |
---|---|
Sep. 30, 2016
USD ($)
$ / shares
shares
| |
Restricted Stock Units (RSUs) [Member] | |
Shares [Roll Forward] | |
RSUs outstanding at beginning of period, Shares | 1,002,188 |
Awarded, Shares | 3,038,386 |
Vested and released, Shares | (1,390,654) |
Forfeited, Shares | (30,309) |
RSUs outstanding at end of period, Shares | 2,619,611 |
Weighted Average Grant DateFair Value [Roll Forward] | |
RSUs outstanding at beginning of period, Weighted Average Grant Date Fair Value (in dollars per share) | $ / shares | $ 5.16 |
Awarded, Weighted Average Grant Date Fair Value (in dollars per share) | $ / shares | 7.38 |
Vested and released, Weighted Average Grant Date Fair Value (in dollars per share) | $ / shares | 5.55 |
Forfeited, Weighted Average Grant Date Fair Value (in dollars per share) | $ / shares | 4.77 |
RSUs outstanding at end of period, Weighted Average Grant Date Fair Value (in dollars per share) | $ / shares | $ 8.21 |
RSUs outstanding at end of period, Weighted Average Remaining Contractual Term | 1 year 11 months 19 days |
RSUs outstanding at end of period, Aggregate Intrinsic Value, in dollars | $ | $ 33,505 |
Bonus RSU Grant [Member] | |
Shares [Roll Forward] | |
Awarded, Shares | 1,072,833 |
Weighted Average Grant DateFair Value [Roll Forward] | |
Grant date fair value | $ | $ 4,500 |
Net Loss Per Share (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands |
3 Months Ended | 9 Months Ended | 12 Months Ended | |||||
---|---|---|---|---|---|---|---|---|
Sep. 30, 2016 |
Sep. 30, 2015 |
Sep. 30, 2016 |
Sep. 30, 2015 |
Dec. 31, 2015 |
Dec. 31, 2014 |
Dec. 31, 2013 |
Dec. 31, 2012 |
|
Earnings Per Share [Abstract] | ||||||||
Net loss, in dollars | $ (11,284) | $ (45,542) | $ (105,345) | $ (120,176) | $ (161,744) | $ (261,297) | $ (238,192) | $ (145,335) |
Shares used in computing basic and diluted net loss per share | 256,319 | 217,587 | 238,024 | 203,153 | ||||
Net loss per share, basic and diluted, in dollars per share | $ (0.04) | $ (0.21) | $ (0.44) | $ (0.59) | $ (0.77) | $ (1.34) | $ (1.29) | $ (0.91) |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||||||
Total potentially dilutive shares | 65,777 | 120,339 | ||||||
Convertible debt [Member] | Convertible Senior Subordinated Notes due 2019 [Member] | ||||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||||||
Total potentially dilutive shares | 413 | 54,118 | ||||||
Convertible debt [Member] | Secured Convertible Notes Due June 2018 [Member] | ||||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||||||
Total potentially dilutive shares | 33,890 | 33,890 | ||||||
Outstanding stock options, unvested RSUs and ESPP contributions [Member] | ||||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||||||
Total potentially dilutive shares | 30,474 | 31,331 | ||||||
Warrants [Member] | ||||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||||||
Total potentially dilutive shares | 1,000 | 1,000 |
Concentrations of Credit Risk (Details) - USD ($) $ in Millions |
3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Sep. 30, 2016 |
Sep. 30, 2015 |
Sep. 30, 2016 |
Sep. 30, 2015 |
|
Customer Concentration Risk [Member] | Accounts Receivable [Member] | Diplomat Specialty Pharmacy [Member] | ||||
Concentration Risk [Line Items] | ||||
Concentration risk (as a percent) | 38.00% | |||
Customer Concentration Risk [Member] | Accounts Receivable [Member] | Caremark L.L.C. [Member] | ||||
Concentration Risk [Line Items] | ||||
Concentration risk (as a percent) | 17.00% | |||
Customer Concentration Risk [Member] | Accounts Receivable [Member] | Accredo Health, Incorporated [Member] | ||||
Concentration Risk [Line Items] | ||||
Concentration risk (as a percent) | 12.00% | |||
Customer Concentration Risk [Member] | Accounts Receivable [Member] | Affiliates of McKessen Corporation [Member] | ||||
Concentration Risk [Line Items] | ||||
Concentration risk (as a percent) | 10.00% | |||
Customer Concentration Risk [Member] | Product Sales [Member] | Diplomat Specialty Pharmacy [Member] | ||||
Concentration Risk [Line Items] | ||||
Concentration risk (as a percent) | 31.00% | 66.00% | 41.00% | 79.00% |
Customer Concentration Risk [Member] | Product Sales [Member] | Sobi [Member] | ||||
Concentration Risk [Line Items] | ||||
Concentration risk (as a percent) | 2.00% | 4.00% | 2.00% | 10.00% |
Customer Concentration Risk [Member] | Collaboration Agreements [Member] | Ipsen [Member] | ||||
Concentration Risk [Line Items] | ||||
Other receivables for milestone payments | $ 60.0 | $ 60.0 | ||
Customer Concentration Risk [Member] | Collaboration Agreements [Member] | Merck [Member] | ||||
Concentration Risk [Line Items] | ||||
Concentration risk (as a percent) | 0.00% | 30.00% | 4.00% | 11.00% |
Customer Concentration Risk [Member] | Collaboration Agreements [Member] | Daiichi Sankyo [Member] | ||||
Concentration Risk [Line Items] | ||||
Concentration risk (as a percent) | 24.00% | 0.00% | 13.00% | 0.00% |
Other receivables for milestone payments | $ 15.0 | $ 15.0 | ||
Geographic Concentration Risk [Member] | Product Sales [Member] | United States [Member] | ||||
Concentration Risk [Line Items] | ||||
Concentration risk (as a percent) | 98.00% | 96.00% | 98.00% | 90.00% |
Geographic Concentration Risk [Member] | Product Sales [Member] | Europe [Member] | ||||
Concentration Risk [Line Items] | ||||
Concentration risk (as a percent) | 2.00% | 4.00% | 2.00% | 10.00% |
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