Cover Page
Cover Page - shares | 9 Months Ended | |
Sep. 30, 2022 | Oct. 24, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2022 | |
Document Transition Report | false | |
Entity File Number | 000-30235 | |
Entity Registrant Name | EXELIXIS, INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 04-3257395 | |
Entity Address, Address Line One | 1851 Harbor Bay Parkway | |
Entity Address, City or Town | Alameda, | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 94502 | |
City Area Code | 650 | |
Local Phone Number | 837-7000 | |
Title of 12(b) Security | Common Stock $.001 Par Value per Share | |
Trading Symbol | EXEL | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding (in shares) | 322,561,418 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q3 | |
Entity Central Index Key | 0000939767 | |
Current Fiscal Year End Date | --12-31 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 675,286 | $ 647,169 |
Short-term investments | 871,706 | 819,905 |
Trade receivables, net | 215,015 | 282,650 |
Inventory | 26,711 | 27,493 |
Prepaid expenses and other current assets | 52,903 | 57,530 |
Total current assets | 1,841,621 | 1,834,747 |
Long-term investments | 551,735 | 371,112 |
Property and equipment, net | 107,909 | 104,031 |
Deferred tax assets, net | 116,415 | 111,663 |
Goodwill | 63,684 | 63,684 |
Other long-term assets | 280,008 | 131,002 |
Total assets | 2,961,372 | 2,616,239 |
Current liabilities: | ||
Accounts payable | 30,572 | 24,258 |
Accrued compensation and benefits | 66,927 | 61,969 |
Accrued clinical trial liabilities | 62,057 | 77,544 |
Rebates and fees due to customers | 43,791 | 33,700 |
Accrued collaboration liabilities | 18,277 | 86,753 |
Other current liabilities | 80,109 | 53,366 |
Total current liabilities | 301,733 | 337,590 |
Long-term portion of deferred revenues | 6,491 | 8,739 |
Long-term portion of operating lease liabilities | 159,838 | 51,272 |
Other long-term liabilities | 1,908 | 8,023 |
Total liabilities | 469,970 | 405,624 |
Commitments and contingencies | ||
Stockholders' equity | ||
Preferred stock, $0.001 par value, 10,000 shares authorized and no shares issued | 0 | 0 |
Common stock, $0.001 par value; 400,000 shares authorized; issued and outstanding: 322,541 and 318,842 at September 30, 2022, and December 31, 2021, respectively | 323 | 319 |
Additional paid-in capital | 2,512,669 | 2,427,561 |
Accumulated other comprehensive loss | (17,538) | (758) |
Accumulated deficit | (4,052) | (216,507) |
Total stockholders' equity | 2,491,402 | 2,210,615 |
Total liabilities and stockholders' equity | $ 2,961,372 | $ 2,616,239 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2022 | Dec. 31, 2021 |
Preferred stock | ||
Par value (in dollars per share) | $ 0.001 | $ 0.001 |
Shares authorized (in shares) | 10,000,000 | 10,000,000 |
Shares issued (in shares) | 0 | 0 |
Common stock | ||
Par value (in dollars per share) | $ 0.001 | $ 0.001 |
Shares authorized (in shares) | 400,000,000 | 400,000,000 |
Shares issued (in shares) | 322,541,000 | 318,842,000 |
Shares outstanding (in shares) | 322,541,000 | 318,842,000 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Income - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Oct. 01, 2021 | Sep. 30, 2022 | Oct. 01, 2021 | |
Revenues: | ||||
Total revenues | $ 411,738 | $ 328,423 | $ 1,187,145 | $ 983,830 |
Operating expenses: | ||||
Cost of goods sold | 15,305 | 11,874 | 41,989 | 39,956 |
Research and development | 198,837 | 163,370 | 554,989 | 471,448 |
Selling, general and administrative | 114,983 | 101,558 | 340,605 | 302,404 |
Total operating expenses | 329,125 | 276,802 | 937,583 | 813,808 |
Income from operations | 82,613 | 51,621 | 249,562 | 170,022 |
Interest income | 9,498 | 1,658 | 16,077 | 6,231 |
Other income (expense), net | (69) | (19) | 140 | (120) |
Income before income taxes | 92,042 | 53,260 | 265,779 | 176,133 |
Provision for income taxes | 18,832 | 15,056 | 53,324 | 40,236 |
Net income | $ 73,210 | $ 38,204 | $ 212,455 | $ 135,897 |
Net income per share: | ||||
Basic (in dollars per share) | $ 0.23 | $ 0.12 | $ 0.66 | $ 0.43 |
Diluted (in dollars per share) | $ 0.23 | $ 0.12 | $ 0.65 | $ 0.42 |
Weighted-average common shares outstanding: | ||||
Basic (in shares) | 322,148 | 315,380 | 320,949 | 313,990 |
Diluted (in shares) | 325,066 | 322,022 | 324,420 | 322,084 |
Net product revenues | ||||
Revenues: | ||||
Total revenues | $ 366,482 | $ 263,117 | $ 1,023,824 | $ 774,577 |
License revenues | ||||
Revenues: | ||||
Total revenues | 34,384 | 49,694 | 123,977 | 116,862 |
Collaboration services revenues | ||||
Revenues: | ||||
Total revenues | $ 10,872 | $ 15,612 | $ 39,344 | $ 92,391 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Income - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Oct. 01, 2021 | Sep. 30, 2022 | Oct. 01, 2021 | |
Statement of Comprehensive Income [Abstract] | ||||
Net income | $ 73,210 | $ 38,204 | $ 212,455 | $ 135,897 |
Other comprehensive loss: | ||||
Net unrealized losses on available-for-sale debt securities, net of tax impact of $2,457, $193, $4,752 and $949, respectively | (8,621) | (504) | (16,780) | (2,995) |
Comprehensive income | $ 64,589 | $ 37,700 | $ 195,675 | $ 132,902 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Comprehensive Income (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Oct. 01, 2021 | Sep. 30, 2022 | Oct. 01, 2021 | |
Statement of Comprehensive Income [Abstract] | ||||
Net unrealized gains (losses) on available-for-sale debt securities, net of tax impact | $ 2,457 | $ 193 | $ 4,752 | $ 949 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Stockholders' Equity - USD ($) shares in Thousands, $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit |
Beginning balance (in shares) at Jan. 01, 2021 | 311,627 | ||||
Beginning balance at Jan. 01, 2021 | $ 1,879,113 | $ 312 | $ 2,321,895 | $ 4,476 | $ (447,570) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net income | 135,897 | 135,897 | |||
Other comprehensive loss | (2,995) | (2,995) | |||
Issuance of common stock under equity incentive plans and stock purchase plan (in shares) | 4,678 | ||||
Issuance of common stock under equity incentive plans and stock purchase plan | 18,792 | $ 4 | 18,788 | ||
Stock transactions associated with taxes withheld on equity awards | (15,371) | (15,371) | |||
Stock-based compensation | 97,011 | 97,011 | |||
Ending balance (in shares) at Oct. 01, 2021 | 316,305 | ||||
Ending balance at Oct. 01, 2021 | 2,112,447 | $ 316 | 2,422,323 | 1,481 | (311,673) |
Beginning balance (in shares) at Jul. 02, 2021 | 314,822 | ||||
Beginning balance at Jul. 02, 2021 | 2,043,077 | $ 315 | 2,390,654 | 1,985 | (349,877) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net income | 38,204 | 38,204 | |||
Other comprehensive loss | (504) | (504) | |||
Issuance of common stock under equity incentive plans and stock purchase plan (in shares) | 1,483 | ||||
Issuance of common stock under equity incentive plans and stock purchase plan | 3,305 | $ 1 | 3,304 | ||
Stock transactions associated with taxes withheld on equity awards | (5,958) | (5,958) | |||
Stock-based compensation | 34,323 | 34,323 | |||
Ending balance (in shares) at Oct. 01, 2021 | 316,305 | ||||
Ending balance at Oct. 01, 2021 | $ 2,112,447 | $ 316 | 2,422,323 | 1,481 | (311,673) |
Beginning balance (in shares) at Dec. 31, 2021 | 318,842 | 318,842 | |||
Beginning balance at Dec. 31, 2021 | $ 2,210,615 | $ 319 | 2,427,561 | (758) | (216,507) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net income | 212,455 | 212,455 | |||
Other comprehensive loss | (16,780) | (16,780) | |||
Issuance of common stock under equity incentive plans and stock purchase plan (in shares) | 3,699 | ||||
Issuance of common stock under equity incentive plans and stock purchase plan | 18,680 | $ 4 | 18,676 | ||
Stock transactions associated with taxes withheld on equity awards | (16,091) | (16,091) | |||
Stock-based compensation | $ 82,523 | 82,523 | |||
Ending balance (in shares) at Sep. 30, 2022 | 322,541 | 322,541 | |||
Ending balance at Sep. 30, 2022 | $ 2,491,402 | $ 323 | 2,512,669 | (17,538) | (4,052) |
Beginning balance (in shares) at Jul. 01, 2022 | 321,800 | ||||
Beginning balance at Jul. 01, 2022 | 2,391,260 | $ 322 | 2,477,117 | (8,917) | (77,262) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net income | 73,210 | 73,210 | |||
Other comprehensive loss | (8,621) | (8,621) | |||
Issuance of common stock under equity incentive plans and stock purchase plan (in shares) | 741 | ||||
Issuance of common stock under equity incentive plans and stock purchase plan | 2,848 | $ 1 | 2,847 | ||
Stock transactions associated with taxes withheld on equity awards | (4,906) | (4,906) | |||
Stock-based compensation | $ 37,611 | 37,611 | |||
Ending balance (in shares) at Sep. 30, 2022 | 322,541 | 322,541 | |||
Ending balance at Sep. 30, 2022 | $ 2,491,402 | $ 323 | $ 2,512,669 | $ (17,538) | $ (4,052) |
Condensed Consolidated Statem_5
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Oct. 01, 2021 | |
Statement of Cash Flows [Abstract] | ||
Net income | $ 212,455 | $ 135,897 |
Adjustments to reconcile net income to net cash provided by operating activities: | ||
Depreciation and amortization | 14,929 | 11,699 |
Stock-based compensation | 81,718 | 96,654 |
Non-cash lease expense | 11,931 | 3,952 |
Deferred taxes | 0 | 32,365 |
Other, net | 7,390 | 35,871 |
Changes in operating assets and liabilities: | ||
Trade receivables, net | 66,890 | (20,124) |
Inventory | (9,836) | (26,956) |
Prepaid expenses and other assets | (35,166) | (24,252) |
Deferred revenue | (3,130) | 11,434 |
Accrued collaboration liabilities | (64,976) | 13,947 |
Accounts payable and other liabilities | 6,715 | 33,865 |
Net cash provided by operating activities | 288,920 | 304,352 |
Cash flows from investing activities: | ||
Purchases of property, equipment and other | (25,989) | (48,265) |
Purchases of investments | (1,079,411) | (1,077,377) |
Proceeds from maturities and sales of investments | 826,768 | 1,095,813 |
Net cash used in investing activities | (278,632) | (29,829) |
Cash flows from financing activities: | ||
Proceeds from issuance of common stock under equity incentive plans | 18,680 | 18,242 |
Taxes paid related to net share settlement of equity awards | (16,091) | (15,049) |
Net cash provided by financing activities | 2,589 | 3,193 |
Net increase in cash, cash equivalents, and restricted cash equivalents | 12,877 | 277,716 |
Cash, cash equivalents and restricted cash equivalents at beginning of period | 663,891 | 320,772 |
Cash, cash equivalents and restricted cash equivalents at end of period | 676,768 | 598,488 |
Non-cash operating activities: | ||
Right-of-use assets obtained in exchange for lease obligations | 121,958 | 4,893 |
Non-cash investing activities: | ||
Unpaid liabilities incurred for purchases of property and equipment | 1,643 | 5,143 |
Unpaid liabilities incurred in asset acquisition | $ 500 | $ 9,000 |
Organization and Summary of Sig
Organization and Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2022 | |
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 an oncology-focused biotechnology company that strives to accelerate the discovery, development and commercialization of new medicines for patients with difficult-to-treat cancers. Using our considerable drug discovery, development and commercialization resources and capabilities, we have invented and brought to market innovative therapies that appropriately balance patient benefits and risks; we will continue to build on this foundation as we strive to provide cancer patients with new treatment options that improve upon current standards of care. Today, four products that originated in Exelixis laboratories are available to be prescribed to patients. Sales related to our flagship molecule, cabozantinib, account for the large majority of our revenues. Cabozantinib is an inhibitor of multiple tyrosine kinases including MET, AXL, VEGF receptors and RET and has been approved by the U.S. Food and Drug Administration (FDA) and in 62 other countries as: CABOMETYX® (cabozantinib) tablets approved for advanced renal cell carcinoma (RCC), both alone and in combination with Bristol-Myers Squibb Company’s (BMS) OPDIVO® (nivolumab), for previously treated hepatocellular carcinoma (HCC) and, currently by the FDA and European Commission (EC), for previously treated, radioactive iodine (RAI)-refractory differentiated thyroid cancer (DTC); and COMETRIQ® (cabozantinib) capsules approved for progressive, metastatic medullary thyroid cancer (MTC). For physicians treating these types of cancer, cabozantinib has become or is becoming an important medicine in their selection of effective therapies. The other two products resulting from our discovery efforts are: COTELLIC® (cobimetinib), an inhibitor of MEK approved as part of multiple combination regimens to treat specific forms of advanced melanoma and marketed under a collaboration with Genentech, Inc. a member of the Roche Group (Genentech); and MINNEBRO® (esaxerenone), an oral, non-steroidal, selective blocker of the mineralocorticoid receptor approved for the treatment of hypertension in Japan and licensed to Daiichi Sankyo Company, Limited (Daiichi Sankyo). Basis of Presentation The accompanying 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. The accompanying unaudited Condensed Consolidated Financial Statements have been prepared in accordance with accounting principles generally accepted in the U.S. 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 our financial statements for the periods presented have been included. Operating results for the nine months ended September 30, 2022 are not necessarily indicative of the results that may be expected for the year ending December 31, 2022 or for any future period. The accompanying Condensed Consolidated Financial Statements and Notes thereto should be read in conjunction with our Consolidated Financial Statements and Notes included in Part II, Item 8 of our Annual Report on Form 10-K for the fiscal year ended December 31, 2021, filed with the SEC on February 18, 2022 (Fiscal 2021 Form 10-K). We have adopted a 52- or 53-week fiscal year policy that generally ends on the Friday closest to December 31 st . Fiscal year 2022, which is a 52-week fiscal year, will end on December 30, 2022 and fiscal year 2021, which was a 52-week fiscal year, ended on December 31, 2021. For convenience, references in this report as of and for the fiscal period ended October 1, 2021, and as of and for the fiscal year ending December 30, 2022 are indicated as being as of and for the period ended September 30, 2021, and the year ending December 31, 2022, respectively. Segment Information We operate in one business segment that focuses on the discovery, development and commercialization of new medicines for difficult-to-treat cancers. Our Chief Executive Officer, as the chief operating decision-maker, manages and allocates resources to our operations on a total consolidated basis. Consistent with this decision-making process, our Chief Executive Officer uses consolidated, single-segment financial information for purposes of evaluating performance, forecasting future period financial results, allocating resources and setting incentive targets. All of our long-lived assets are located in the U.S. See “Note 2. Revenues” for enterprise-wide disclosures about product sales, revenues from major customers and revenues by geographic region. Use of Estimates The preparation of the accompanying Condensed Consolidated Financial Statements conforms to accounting principles generally accepted in the U.S., which requires management to make judgments, estimates and assumptions that affect the reported amounts of assets, liabilities, equity, revenues and expenses, and related disclosures. On an ongoing basis, we evaluate our significant estimates. 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. Reclassifications Certain prior period amounts in the accompanying Condensed Consolidated Financial Statements have been reclassified to conform to the current period presentation. Such reclassifications did not impact previously reported total revenues, income from operations, net income, total assets, total liabilities or total stockholders’ equity. Significant Accounting Policies There have been no material changes to our significant accounting policies during the nine months ended September 30, 2022, compared to the significant accounting policies disclosed in “Note 1. Organization and Summary of Significant Accounting Policies” of the “Notes to Consolidated Financial Statements” included in Part II, Item 8 of our Fiscal 2021 Form 10-K. Recently Adopted Accounting Pronouncements There were no new accounting pronouncements adopted by us since the filing of our Fiscal 2021 Form 10-K, which could have a significant effect on our Condensed Consolidated Financial Statements. Recent Accounting Pronouncements Not Yet Adopted There were no new accounting pronouncements issued since the filing of our Fiscal 2021 Form 10-K, which could have a significant effect on our Condensed Consolidated Financial Statements. |
Revenues
Revenues | 9 Months Ended |
Sep. 30, 2022 | |
Revenue from Contract with Customer [Abstract] | |
REVENUES | REVENUES Revenues consisted of the following (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Product revenues: Gross product revenues $ 496,141 $ 357,462 $ 1,427,451 $ 1,051,871 Discounts and allowances (129,659) (94,345) (403,627) (277,294) Net product revenues 366,482 263,117 1,023,824 774,577 Collaboration revenues: License revenues 34,384 49,694 123,977 116,862 Collaboration services revenues 10,872 15,612 39,344 92,391 Total collaboration revenues 45,256 65,306 163,321 209,253 Total revenues $ 411,738 $ 328,423 $ 1,187,145 $ 983,830 The percentage of total revenues by customer who individually accounted for 10% or more of our total revenues were as follows: Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Affiliates of McKesson Corporation 18 % 15 % 18 % 15 % Affiliates of CVS Health Corporation 19 % 16 % 17 % 15 % Affiliates of AmerisourceBergen Corporation 18 % 16 % 16 % 14 % Ipsen Pharma SAS 8 % 12 % 11 % 17 % Accredo Health, Incorporated 11 % 9 % 10 % 8 % The percentage of trade receivables by customer who individually accounted for 10% or more of our trade receivables were as follows: September 30, 2022 December 31, 2021 Affiliates of McKesson Corporation 23 % 10 % Ipsen Pharma SAS 21 % 50 % Affiliates of AmerisourceBergen Corporation 20 % 11 % Affiliates of CVS Health Corporation 15 % 9 % Revenues by geographic region were as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 U.S. $ 369,480 $ 266,436 $ 1,033,160 $ 783,583 Europe 34,818 38,095 131,585 162,822 Japan 7,440 23,892 22,400 37,425 Total revenues $ 411,738 $ 328,423 $ 1,187,145 $ 983,830 Total revenues include net product revenues attributed to geographic regions based on the ship-to location and license and collaboration services revenues attributed to geographic regions based on the location of our collaboration partners’ headquarters. Net product revenues and license revenues are recorded in accordance with ASC Topic 606, Revenue from Contracts with Customers (Topic 606). License revenues include the recognition of the portion of milestone payments allocated to the transfer of intellectual property licenses for which it had become probable in the current period that the milestone would be achieved and a significant reversal of revenues would not occur, as well as royalty revenues and our share of profits under our collaboration agreement with Genentech. Collaboration services revenues were recorded in accordance with ASU 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606 and by analogy to Topic 606. Collaboration services revenues include the recognition of deferred revenues for the portion of upfront and milestone payments allocated to our research and development services performance obligations, development cost reimbursements earned under our collaboration agreements, product supply revenues, net of product supply costs, and the royalties we paid on sales of products containing cabozantinib by our collaboration partners. Net product revenues by product were as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 CABOMETYX $ 361,385 $ 259,791 $ 1,003,356 $ 759,000 COMETRIQ 5,097 3,326 20,468 15,577 Net product revenues $ 366,482 $ 263,117 $ 1,023,824 $ 774,577 Product Sales Discounts and Allowances The activities and ending reserve balances for each significant category of discounts and allowances, which constitute variable consideration, were as follows (in thousands): Chargebacks, Discounts for Prompt Payment and Other Other Customer Credits/Fees and Co-pay Assistance Rebates Total Balance at December 31, 2021 $ 14,625 $ 8,875 $ 24,825 $ 48,325 Provision related to sales made in: Current period 261,143 36,847 105,280 403,270 Prior periods 632 (169) (106) 357 Payments and customer credits issued (255,002) (32,765) (98,996) (386,763) Balance at September 30, 2022 $ 21,398 $ 12,788 $ 31,003 $ 65,189 The allowance for chargebacks, discounts for prompt payment and other are recorded as a reduction of trade receivables, net, and the remaining reserves are recorded as rebates and fees due to customers in the accompanying Condensed Consolidated Balance Sheets. Contract Assets and Liabilities We receive payments from our collaboration partners based on billing schedules established in each contract. Amounts are recorded as accounts receivable when our right to consideration is unconditional. We may also recognize revenue in advance of the contractual billing schedule, and such amounts are recorded as a contract asset when recognized. We may be required to defer recognition of revenue for upfront and milestone payments until we perform our obligations under these arrangements, and such amounts are recorded as deferred revenue upon receipt or when due. For those contracts that have multiple performance obligations, contract assets and liabilities are reported on a net basis at the contract level. Contract assets are primarily related to Ipsen Pharma SAS (Ipsen) and contract liabilities are primarily related to deferred revenues from Takeda Pharmaceutical Company Limited (Takeda). Contract assets and liabilities were as follows (in thousands): September 30, 2022 December 31, 2021 Contract assets (1) $ 364 $ 1,665 Contract liabilities: Current portion (2) $ 6,932 $ 7,814 Long-term portion (3) 6,491 8,739 Total contract liabilities $ 13,423 $ 16,553 ____________________ (1) Presented in other long-term assets in the accompanying Condensed Consolidated Balance Sheets. (2) Presented in other current liabilities in the accompanying Condensed Consolidated Balance Sheets. (3) Presented in the long-term portion of deferred revenues in the accompanying Condensed Consolidated Balance Sheets During the nine months ended September 30, 2022 and 2021, we recognized $6.6 million and $6.8 million, respectively, in revenues that were included in the beginning deferred revenues balance for those periods. During the three and nine months ended September 30, 2022, we recognized $33.9 million and $125.0 million, respectively, in revenues for performance obligations satisfied in previous periods, as compared to $48.4 million and $116.2 million for the corresponding prior year periods. Such revenues were primarily related to royalty payments allocated to the license performance obligations for our collaborations with Ipsen, Takeda, Daiichi Sankyo and Genentech and the recognition of license revenue for the achievement of milestones during the second quarter of 2022, allocated to the license performance obligations for our collaboration with Ipsen. As of September 30, 2022, $83.1 million of t he co mbined transaction prices for our Ipsen a nd Takeda collaborations were allocated to our research and development services performance obligations that had not yet been satisfied. See “Note 3. Collaboration Agreements and Business Development Activities” of the “Notes to Consolidated Financial Statements” included in Part II, Item 8 of our Fiscal 2021 Form 10-K for additional information about the expected timing to satisfy these performance obligations. |
Collaboration Agreements And Bu
Collaboration Agreements And Business Development Activities | 9 Months Ended |
Sep. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
COLLABORATION AGREEMENTS AND BUSINESS DEVELOPMENT ACTIVITIES | COLLABORATION AGREEMENTS AND BUSINESS DEVELOPMENT ACTIVITIES We have established multiple collaborations with leading pharmaceutical companies for the commercialization and further development of our cabozantinib franchise. Additionally, we have entered into several research collaborations, in-licensing arrangements and other strategic transactions to further enhance our early-stage pipeline and expand our ability to discover, develop and commercialize novel therapies with the goal of providing new treatment options for cancer patients and their physicians. Historically, we also entered into other collaborations with leading pharmaceutical companies pursuant to which we out-licensed other compounds and programs in our portfolio. See “Note 3. Collaboration Agreements and Business Development Activities” of the “Notes to Consolidated Financial Statements” included in Part II, Item 8 of our Fiscal 2021 Form 10-K, as further described below, for additional information on certain of our collaboration agreements and in-licensing arrangements. Cabozantinib Commercial Collaborations Ipsen Collaboration In February 2016, we entered into a collaboration agreement with Ipsen for the commercialization and further development of cabozantinib. Under the terms of the collaboration agreement, as amended, Ipsen received exclusive commercialization rights for current and potential future cabozantinib indications outside of the U.S. and Japan. We have also agreed to collaborate with Ipsen on the development of cabozantinib for current and potential future indications. The parties’ efforts are governed through a joint steering committee and appropriate subcommittees established to guide and oversee the collaboration’s operation and strategic direction; provided, however, that we retain final decision-making authority with respect to cabozantinib’s ongoing development. Revenues under the collaboration agreement with Ipsen were as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 License revenues $ 27,607 $ 25,139 $ 103,389 $ 81,246 Collaboration services revenues 7,211 12,956 28,196 81,576 Total $ 34,818 $ 38,095 $ 131,585 $ 162,822 During the nine months ended September 30, 2022, we recognized $25.8 million in revenues in connection with two regulatory milestones totaling $27.0 million upon approval by the European Commission and Health Canada, of cabozantinib as monotherapy for the treatment of adult patients with locally advanced or metastatic differentiated thyroid carcinoma (DTC), refractory or not eligible to RAI who have progressed during or after prior systemic therapy. As of September 30, 2022, $49.3 million of the transaction price for this collaboration was allocated to our research and development services performance obligations that have not yet been satisfied. Takeda Collaboration In January 2017, we entered into a collaboration and license agreement with Takeda for the commercialization and further development of cabozantinib. Pursuant to this collaboration and license agreement, as amended, Takeda has exclusive commercialization rights for current and potential future cabozantinib indications in Japan, and the parties have agreed to collaborate on the clinical development of cabozantinib in Japan. The operation and strategic direction of the parties’ collaboration is governed through a joint executive committee and appropriate subcommittees. Revenues under the collaboration agreement with Takeda were as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 License revenues $ 2,690 $ 20,078 $ 7,755 $ 23,476 Collaboration services revenues 3,661 2,656 11,148 10,815 Total $ 6,351 $ 22,734 $ 18,903 $ 34,291 As of September 30, 2022 , $33.8 million of the transaction price for this collaboration was allocated to our research and development services performance obligations that have not yet been satisfied. Royalty Pharma In October 2002, we established a product development and commercialization collaboration agreement with GlaxoSmithKline (GSK), that required us to pay a 3% royalty to GSK on the worldwide net sales of any product incorporating cabozantinib sold by us and our collaboration partners. Effective January 1, 2021, Royalty Pharma plc (Royalty Pharma) acquired from GSK all rights, title and interest in royalties on net product sales containing cabozantinib for non-U.S. markets for the full term of the royalty and for U.S. market through September 2026, after which time U.S. royalties will revert back to GSK. Royalties earned by Royalty Pharma in connection with our sales of cabozantinib are included in cost of goods sold and in connection with sales by our collaboration partners are included as a reduction of collaboration services revenues. Such royalties were $14.9 million and $42.6 million during the three and nine months ended September 30, 2022, respectively, as compared to $11.5 million and $33.7 million for the corresponding prior year periods. Other Commercial Collaborations Genentech Collaboration In December 2006, we out-licensed the development and commercialization of cobimetinib to Genentech under a worldwide collaboration agreement. In November 2015, the FDA approved cobimetinib, under the brand name COTELLIC, in combination with Genentech’s ZELBORAF® (vemurafenib) for the treatment of patients with BRAF V600E or V600K mutation-positive advanced melanoma. COTELLIC in combination with ZELBORAF has also been approved in the European Union and multiple additional countries for use in the same indication. In July 2020, the FDA also approved COTELLIC for use in combination with ZELBORAF and TECENTRIQ® (atezolizumab) for the treatment of patients with BRAF V600 mutation-positive advanced melanoma in previously untreated patients. License revenues under the collaboration agreement with Genentech were as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Profits on U.S. commercialization $ 1,504 $ 1,743 $ 5,325 $ 5,697 Royalty revenues on ex-U.S. sales $ 1,494 $ 1,576 $ 4,011 $ 3,309 Research Collaborations, In-Licensing Arrangements and Other Business Development Activities Our research collaborations, in-licensing arrangements and other strategic transactions include upfront payments, which are generally paid upon the closing of the transaction, and also milestone payments (in connection with development, regulatory or commercial achievements) and royalty payments, which are contingent upon the occurrence of certain future events linked to the success of the asset in development. Certain of our research collaborations and in-licensing arrangements provide us exclusive options that give us the right to license programs developed under the research collaborations for further discovery and development. When we decide to exercise an option, we are required to pay an exercise fee and then, in most instances, we will assume the responsibilities for all subsequent clinical development, manufacturing and commercialization of the licensed asset. In June 2022, we entered into an exclusive option and license agreement with BioInvent International AB (BioInvent), upon which we paid an upfront payment of $25.0 million. Upon option exercise, we will pay BioInvent an option exercise fee, and BioInvent will be eligible for additional payments from us for future development and commercial milestones, as well as royalties on our future net product sales. In July 2022, we entered into an exclusive license agreement with Ryvu Therapeutics S.A. (Ryvu) and paid an upfront payment of $3.0 million. Ryvu is eligible for potential future development and commercial milestones as well as royalties on future net product sales. As of September 30, 2022, in conjunction with each of our research collaborations and in-licensing arrangements, and an asset purchase agreement entered into in 2021, we are subject to contingent payments for potential future development milestones of up to $364.7 million, regulatory milestones of up to $453.4 million and commercial milestones of up to $2,443.4 million, each in the aggregate per product or target, as well as royalties on future net product sales. |
Cash and Investments
Cash and Investments | 9 Months Ended |
Sep. 30, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
CASH AND INVESTMENTS | CASH AND INVESTMENTS Cash, Cash Equivalents and Restricted Cash Equivalents A reconciliation of cash, cash equivalents, and restricted cash equivalents reported in the accompanying Condensed Consolidated Balance Sheets to the amount reported within the accompanying Condensed Consolidated Statements of Cash Flows was as follows (in thousands): September 30, 2022 December 31, 2021 Cash and cash equivalents $ 675,286 $ 647,169 Restricted cash equivalents included in other long-term assets 1,482 16,722 Cash, cash equivalents, and restricted cash equivalents as reported in the accompanying Condensed Consolidated Statements of Cash Flows $ 676,768 $ 663,891 Restricted cash equivalents are used to collateralize letters of credit and consist of money-market funds and certificates of deposit with original maturities of 90 days or less. The restricted cash equivalents are classified as other long-term assets based upon the remaining term of the underlying restriction. The standby letter of credit entered in January 2021, as a guarantee of our obligation to fund our portion of the tenant improvements related to our Alameda build-to-suit lease was terminated and the related collateral was returned in the third quarter of 2022, following the substantial completion of the building and the commencement of the lease. Cash, Cash Equivalents, Restricted Cash Equivalents and Investments Cash, cash equivalents, restricted cash equivalents and investments consisted of the following (in thousands): September 30, 2022 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Debt securities available-for-sale: Commercial paper $ 874,220 $ — $ (364) $ 873,856 Corporate bonds 633,617 — (15,495) 618,122 U.S. Treasury and government-sponsored enterprises 307,494 — (6,157) 301,337 Municipal bonds 16,565 — (312) 16,253 Total debt securities available-for-sale 1,831,896 — (22,328) 1,809,568 Cash 113,492 — — 113,492 Money market funds 62,968 — — 62,968 Certificates of deposit 114,181 — — 114,181 Total cash, cash equivalents, restricted cash equivalents and investments $ 2,122,537 $ — $ (22,328) $ 2,100,209 December 31, 2021 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Debt securities available-for-sale: Commercial paper $ 945,801 $ 42 $ (2) $ 945,841 Corporate bonds 541,774 876 (1,672) 540,978 U.S. Treasury and government-sponsored enterprises 33,965 1 (21) 33,945 Municipal bonds 12,924 15 (35) 12,904 Total debt securities available-for-sale 1,534,464 934 (1,730) 1,533,668 Cash 135,653 — — 135,653 Money market funds 66,531 — — 66,531 Certificates of deposit 119,056 — — 119,056 Total cash, cash equivalents, restricted cash equivalents and investments $ 1,855,704 $ 934 $ (1,730) $ 1,854,908 Interest receivable was $4.8 million and $2.9 million as of September 30, 2022 and December 31, 2021, respectively, and is included in prepaid expenses and other current assets in the accompanying Condensed Consolidated Balance Sheets. Realized gains and losses on the sales of investments were insignificant during the three and nine months ended September 30, 2022 and 2021. We manage credit risk associated with our investment portfolio through our investment policy, which limits purchases to high-quality issuers and limits the amount of our portfolio that can be invested in a single issuer. The fair value and gross unrealized losses on debt securities available-for-sale in an unrealized loss position were as follows (in thousands): September 30, 2022 Fair Value Gross Unrealized Losses Corporate bonds $ 613,122 $ (15,495) U.S. Treasury and government-sponsored enterprises 301,337 (6,157) Commercial paper 36,636 (364) Municipal bonds 16,073 (312) Total $ 967,168 $ (22,328) December 31, 2021 Fair Value Gross Unrealized Losses Corporate bonds $ 385,053 $ (1,672) Commercial paper 43,290 (2) U.S. Treasury and government-sponsored enterprises 18,962 (21) Municipal bonds 7,475 (35) Total $ 454,780 $ (1,730) There were 276 and 133 investments in an unrealized loss position as of September 30, 2022 and December 31, 2021, respectively. All securities presented above have been in an unrealized loss position for less than twelve months except for 25 corporate bond securities and 1 municipal bond security with an aggregate fair value of $64.0 million and an aggregate $2.4 million unrealized loss as of September 30, 2022 . During the nine months ended September 30, 2022 and 2021, we did not record an allowance for credit losses or other impairment charges on our investment securities. Based upon our quarterly impairment review, we determined that the unrealized losses were not attributed to credit risk but were primarily associated with changes in interest rates and market liquidity. Based on the scheduled maturities of our investments, we determined that it was more likely than not that we will hold these investments for a period of time sufficient for a recovery of our cost basis. The fair value of debt securities available-for-sale by contractual maturity was as follows (in thousands): September 30, 2022 December 31, 2021 Maturing in one year or less $ 1,260,834 $ 1,168,256 Maturing after one year through five years 548,734 365,412 Total debt securities available-for-sale $ 1,809,568 $ 1,533,668 |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
FAIR VALUE MEASUREMENTS | FAIR VALUE MEASUREMENTS Fair value reflects the amounts that would be received upon sale of an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. The fair value hierarchy has the following three levels: • Level 1 - quoted prices (unadjusted) in active markets for identical assets and liabilities; • Level 2 - inputs other than level 1 that are observable either directly or indirectly, such as quoted prices in active markets for similar instruments or on industry models using data inputs, such as interest rates and prices that can be directly observed or corroborated in active markets; and • Level 3 - unobservable inputs that are supported by little or no market activity that are significant to the fair value measurement. The classifications within the fair value hierarchy of our financial assets that were measured and recorded at fair value on a recurring basis were as follows (in thousands): September 30, 2022 Level 1 Level 2 Total Commercial paper $ — $ 873,856 $ 873,856 Corporate bonds — 618,122 618,122 U.S. Treasury and government-sponsored enterprises — 301,337 301,337 Municipal bonds — 16,253 16,253 Total debt securities available-for-sale — 1,809,568 1,809,568 Money market funds 62,968 — 62,968 Certificates of deposit — 114,181 114,181 Total financial assets carried at fair value $ 62,968 $ 1,923,749 $ 1,986,717 December 31, 2021 Level 1 Level 2 Total Commercial paper $ — $ 945,841 $ 945,841 Corporate bonds — 540,978 540,978 U.S. Treasury and government-sponsored enterprises — 33,945 33,945 Municipal bonds — 12,904 12,904 Total debt securities available-for-sale — 1,533,668 1,533,668 Money market funds 66,531 — 66,531 Certificates of deposit — 119,056 119,056 Total financial assets carried at fair value $ 66,531 $ 1,652,724 $ 1,719,255 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 for similar assets as observable inputs for pricing, which is a Level 2 input. The carrying amount of our remaining financial assets and liabilities, which include cash, receivables and payables, approximate their fair values due to their short-term nature. Forward Foreign Currency Contracts We have entered into forward contracts to hedge certain operational exposures for the changes in foreign currency exchanges rates associated with assets or liabilities denominated in foreign currencies, primarily the Euro. As of September 30, 2022 , we had one forward contract outstanding to sell €10.0 million. The forward contract with a maturity of three months is recorded at fair value and is included in prepaid expenses and other current assets in the Condensed Consolidated Balance Sheets. The unrealized loss on the forward contract is not material as of September 30, 2022. The forward contract is considered a Level 2 in the fair value hierarchy of our fair value measurements. For the nine months period ended September 30, 2022, and 2021, we recognized $1.5 million and $0.5 million, respectively, of net gains on the maturity of our forward contracts, which is included in other income (expense), net on our Condensed Consolidated Statements of Income. |
Inventory
Inventory | 9 Months Ended |
Sep. 30, 2022 | |
Inventory Disclosure [Abstract] | |
INVENTORY | INVENTORY Inventory consisted of the following (in thousands): September 30, 2022 December 31, 2021 Raw materials $ 9,447 $ 8,867 Work in process 39,380 27,717 Finished goods 11,325 12,927 Total $ 60,152 $ 49,511 Balance Sheet classification: Current portion included in inventory $ 26,711 $ 27,493 Long-term portion included in other long-term assets 33,441 22,018 Total $ 60,152 $ 49,511 |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
STOCK-BASED COMPENSATION | STOCK-BASED COMPENSATION We allocated the stock-based compensation expense for our equity incentive plans and our Employee Stock Purchase Plan (ESPP) as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Research and development $ 16,438 $ 11,487 $ 34,886 $ 37,550 Selling, general and administrative 20,899 22,479 46,832 59,104 Total stock-based compensation expense $ 37,337 $ 33,966 $ 81,718 $ 96,654 Stock-based compensation for each type of award under our equity incentive plans and ESPP were as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Stock options $ 3,299 $ 4,607 $ 10,470 $ 15,203 Restricted stock units 22,233 13,721 54,234 40,802 Performance stock units 11,331 14,971 14,621 37,616 ESPP 474 667 2,393 3,033 Total stock-based compensation expense $ 37,337 $ 33,966 $ 81,718 $ 96,654 On May 25, 2022, at the 2022 Annual Meeting of Stockholders, our stockholders approved the amendment and restatement of Exelixis, Inc. 2017 Equity Incentive Plan (as amended and restated, the 2017 Plan). The amendment and restatement increased the share reserve under the 2017 Plan by 28,500,000 shares. As of September 30, 2022, 31,485,656 sh ares were available for grant under the 2017 Plan. The share reserve is reduced by 1 share for each share issued pursuant to a stock option and 2 shares for full value awards, including restricted stock units (RSUs). During the nine months ended September 30, 2022, we granted 588,862 stock options with a weighted average exercise price of $19.99 per share and a weighted average grant date fair value of $8.36 per s hare. As of September 30, 2022 , there were 11,416,151 stock options outstanding and $19.6 million of related unrecognized compensation expense. In March 2022, we awarded to certain employees an aggregate of 1,003,482 (the target amount) RSUs that are subject to a total shareholder return (TSR) market condition (the TSR-based RSUs). The TSR market condition is based on our relative TSR percentile rank compared to companies in the NASDAQ Biotechnology Index during the performance period, which is January 1, 2022 through January 3, 2025. Depending on the results relative to the TSR market condition, the holders of the TSR-based RSUs may earn up to 175% of the target amount of shares. 50% of the shares earned pursuant to the TSR-based RSU awards will vest at the end of the performance period, and the remainder will vest approximately one year later, subject to employee’s continuous service. These TSR-based RSUs will be forfeited if the market condition at or above a threshold level is not achieved at the end of the performance period on January 3, 2025. We used a Monte Carlo simulation model and the following assumptions to determine the grant date fair value of $33.17 per share for the TSR-based RSUs: Fair value of the Company’s common stock on grant date $ 20.70 Expected volatility 46.85 % Risk-free interest rate 1.59 % Dividend yield — % The Monte Carlo simulation model also assumed correlations of returns of the stock prices of the Company’s common stock and the common stock of a peer group of companies and historical stock price volatility of the peer group of companies. The valuation model also used terms based on the length of the performance period and compound annual growth rate goals for total stockholder return based on the provisions of the award. During the nine months ended September 30, 2022, we granted 5,292,088 service-based RSUs with a weighted average grant date fair value of $20.56 per share. As of September 30, 2022 , there were 11,864,173 RSUs outstanding, including the TSR-based RSUs, and $193.8 million of related unrecognized compensation expense. Stock options and service-based RSUs granted to employees during the nine months ended September 30, 2022 have vesting conditions and contractual lives of a similar nature to those described in “Note 8. Employee Benefit Plans” of the “Notes to Consolidated Financial Statements” included in Part II, Item 8 of our Fiscal 2021 Form 10-K. As of September 30, 2022 , there were 5,367,906 performance-based restricted stock units (PSUs) outstanding and $101.0 million of related unrecognized stock-based compensation expense. Expense recognition for PSUs commences when it is determined that achievement of the performance target is probable. During the three months ended September 30, 2022, we achieved a performance condition for threshold achievement for 495,886 PSUs granted during 2020 (the 2020 PSUs) and have recognized $9.7 million of stock-based compensation expense related to the 2020 PSUs during the three |
Provision For Income Taxes
Provision For Income Taxes | 9 Months Ended |
Sep. 30, 2022 | |
Income Tax Disclosure [Abstract] | |
PROVISION FOR INCOME TAXES | PROVISION FOR INCOME TAXES The effective tax rates for the three and nine months ended September 30, 2022, were 20.5% and 20.1% respectively, as compared to 28.3% and 22.8% for the corresponding periods in 2021. The effective tax rates for the three and nine months ended September 30, 2022 differed from the U.S. federal statutory tax rate of 21% primarily due to excess tax benefits related to the exercise of certain stock options during the periods and the generation of federal tax credits, which were partially offset by state taxes. The effective tax rates for the three and nine months ended September 30, 2021 differed from the U.S. federal statutory tax rate of 21% primarily due to non-deductible executive compensation, which was partially offset by excess tax benefits related to the exercise of certain stock options during the periods and the generation of federal tax credits. |
Net Income Per Share
Net Income Per Share | 9 Months Ended |
Sep. 30, 2022 | |
Earnings Per Share [Abstract] | |
NET INCOME PER SHARE | NET INCOME PER SHARE Net income per share - basic and diluted, were computed as follows (in thousands, except per share amounts): Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Numerator: Net income $ 73,210 $ 38,204 $ 212,455 $ 135,897 Denominator: Weighted-average common shares outstanding — basic 322,148 315,380 320,949 313,990 Dilutive securities 2,918 6,642 3,471 8,094 Weighted-average common shares outstanding — diluted 325,066 322,022 324,420 322,084 Net income per share — basic $ 0.23 $ 0.12 $ 0.66 $ 0.43 Net income per share — diluted $ 0.23 $ 0.12 $ 0.65 $ 0.42 Dilutive securities included outstanding stock options, unvested RSUs, including TSR-based RSUs, PSUs and ESPP contributions. Certain potential common shares were excluded from our calculation of weighted-average common shares outstanding — diluted because either they would have had an anti-dilutive effect on net income per share or they were related to shares from PSUs that were contingently issuable and the contingency had not been satisfied at the end of the reporting period. The weighted-average potential common shares excluded from our calculation were as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Anti-dilutive securities and contingently issuable shares excluded 15,059 20,346 15,311 14,213 |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | COMMITMENTS AND CONTINGENCIES Build-to-Suit Lease and Headquarters Lease In April 2022, the office building (New Premises) associated with our October 2019 build-to-suit lease agreement (Build-to-Suit Lease) was substantially completed. The New Premises is 220,517 square feet and is in Alameda, California, adjacent to our existing corporate headquarters. The Build-to-Suit Lease term is 242 months, includes two five-year options to extend the term of the lease and a one-time option to terminate the lease after 180 months. In addition to the monthly lease payments, currently estimated at $0.7 million, subject to an annual increase of 3% during the Term, we are also responsible for paying operating expenses related to the New Premises. On April 15, 2022, the lease commenced for the New Premises. We determined the classification of the lease was an operating lease. Upon commencement of the lease, we recognized a right-of-use asset of $160.9 million inclusive of $44.9 million for the cost of the tenant improvements in excess of the allowance provided by the lessor and an operating lease liability of $116.0 million discounted over 180 months using our estimated incremental borrowing rate of 4.9%. In May 2022, we entered into the seventh amendment to the lease for our corporate headquarters located on Harbor Bay Parkway, Alameda, California (the Alameda Lease). The May 2022 amendment to the Alameda Lease (the Seventh Lease Amendment) provides, among other things, for the expansion of the premises under the Alameda Lease by 34,745 square feet of office facilities located at 1751 Harbor Bay Parkway, Alameda, California (the 1751 Expansion Space). The term for the 1751 Expansion Space will run coterminous with the term of the Alameda Lease for the existing space. In connection with the Seventh Lease Amendment, we remeasured our lease components under the Alameda Lease relating to the existing premises using an incremental borrowing rate of 5.0%. As of June 1, 2022, we have taken possession of the 1751 Expansion Space, and accordingly we have adjusted our right-of-use asset and liability by $4.3 million. Legal Proceedings MSN I ANDA Litigation In September 2019, we received a notice letter regarding an Abbreviated New Drug Application (ANDA) submitted to the FDA by MSN Pharmaceuticals, Inc. (individually and collectively with certain of its affiliates, including MSN Laboratories Private Limited, referred to as MSN), requesting approval to market a generic version of CABOMETYX tablets. MSN’s initial notice letter included a Paragraph IV certification with respect to our U.S. Patents No. 8,877,776 (salt and polymorphic forms), 9,724,342 (formulations), 10,034,873 (methods of treatment) and 10,039,757 (methods of treatment), which are listed in the Approved Drug Products with Therapeutic Equivalence Evaluations, also referred to as the Orange Book, for CABOMETYX. MSN’s initial notice letter did not provide a Paragraph IV certification against U.S. Patents No. 7,579,473 (composition of matter) or 8,497,284 (methods of treatment), each of which is listed in the Orange Book. On October 29, 2019, we filed a complaint in the United States District Court for the District of Delaware (the Delaware District Court) for patent infringement against MSN asserting infringement of U.S. Patent No. 8,877,776 arising from MSN’s ANDA filing with the FDA. On November 20, 2019, MSN filed its response to the complaint, alleging that the asserted claims of U.S. Patent No. 8,877,776 are invalid and not infringed. On May 5, 2020, we received notice from MSN that it had amended its ANDA to include additional Paragraph IV certifications. In particular, the May 5, 2020 amended ANDA requested approval to market a generic version of CABOMETYX tablets prior to expiration of two previously unasserted CABOMETYX patents: U.S. Patents No. 7,579,473 and 8,497,284. On May 11, 2020, we filed a complaint in the Delaware District Court for patent infringement against MSN asserting infringement of U.S. Patents No. 7,579,473 and 8,497,284 arising from MSN’s amended ANDA filing with the FDA. Neither of our complaints have alleged infringement of U.S. Patents No. 9,724,342, 10,034,873 and 10,039,757. On May 22, 2020, MSN filed its response to the complaint, alleging that the asserted claims of U.S. Patents No. 7,579,473 and 8,497,284 are invalid and not infringed. On March 23, 2021, MSN filed its First Amended Answer and Counterclaims (amending its prior filing from May 22, 2020), seeking, among other things, a declaratory judgment that U.S. Patent No. 9,809,549 (salt and polymorphic forms) is invalid and would not be infringed by MSN if its generic version of CABOMETYX tablets were approved by the FDA. U.S. Patent No. 9,809,549 is not listed in the Orange Book. On April 7, 2021, we filed our response to MSN’s First Amended Answer and Counterclaims, denying, among other things, that U.S. Patent No. 9,809,549 is invalid or would not be infringed. The two lawsuits comprising this litigation (collectively referred to as MSN I), numbered Civil Action Nos. 19-02017 and 20-00633, were consolidated in April 2021. On October 1, 2021, pursuant to a stipulation between us and MSN, the Delaware District Court entered an order that (i) MSN’s submission of its ANDA constitutes infringement of certain claims relating to U.S. Patents No. 7,579,473 and 8,497,284, if those claims are not found to be invalid, and (ii) upon approval, MSN’s commercial manufacture, use, sale or offer for sale within the U.S., and importation into the U.S., of MSN’s ANDA product prior to the expiration of U.S. Patents No. 7,579,473 and 8,497,284 would also infringe certain claims of each patent, if those claims are not found to be invalid. Then, on October 12, 2021, pursuant to a separate stipulation between us and MSN, the Delaware District Court entered an order dismissing MSN’s counterclaims with respect to U.S. Patent No. 9,809,549. In our MSN I complaints, we are seeking, among other relief, an order that the effective date of any FDA approval of MSN’s ANDA be a date no earlier than the expiration of all of U.S. Patents No. 7,579,473, 8,497,284 and 8,877,776, the latest of which expires on October 8, 2030, and equitable relief enjoining MSN from infringing these patents. In an effort to streamline the case, the parties have narrowed their assertions. On April 8, 2022, MSN withdrew its validity challenge to U.S. Patent No. 8,877,776. On April 14, 2022, we agreed not to assert U.S. Patent No. 8,497,284 at trial and MSN has, correspondingly, agreed to withdraw its validity challenges to U.S. Patent No. 8,497,284, as well as claims 1-4 and 6-7 of U.S. Patent No. 7,579,473. As a result of this narrowing, the trial addressed two issues: (1) infringement of claim 1 of the U.S. Patent No. 8,877,776; and (2) validity of claim 5 of the U.S. Patent No. 7,579,473. A bench trial for MSN I occurred in May 2022, and a judgment is expected during the fourth quarter of 2022. MSN II ANDA Litigation On January 11, 2022, we received notice from MSN that it had further amended its ANDA to assert additional Paragraph IV certifications. In particular, the January 11, 2022 amended ANDA requested approval to market a generic version of CABOMETYX tablets prior to expiration of three previously-unasserted CABOMETYX patents that are now listed in the Orange Book: U.S. Patents No. 11,091,439 (crystalline salt forms), 11,091,440 (pharmaceutical composition) and 11,098,015 (methods of treatment). On February 23, 2022, we filed a complaint in the Delaware District Court for patent infringement against MSN asserting infringement of U.S. Patents No. 11,091,439, 11,091,440 and 11,098,015 arising from MSN’s further amendment of its ANDA filing with the FDA. On February 25, 2022, MSN filed its response to the complaint, alleging that the asserted claims of U.S. Patents No. 11,091,439, 11,091,440 and 11,098,015 are invalid and not infringed. On June 7, 2022, we received notice from MSN that it had further amended its ANDA to assert an additional Paragraph IV certification. As currently amended, MSN’s ANDA now requests approval to market a generic version of CABOMETYX tablets prior to expiration of a previously-unasserted CABOMETYX patent that is now listed in the Orange Book: U.S. Patent No. 11,298,349 (pharmaceutical composition). On July 18, 2022, we filed a complaint in the Delaware District Court for patent infringement against MSN asserting infringement of U.S. Patent No. 11,298,349 arising from MSN’s further amendment of its ANDA Filing with the FDA. On August 9, 2022, MSN filed its response to the complaint, alleging that the asserted claims of U.S. Patent No. 11,298,349 are invalid and not infringed. The two lawsuits comprising this litigation (collectively referred to as MSN II), numbered Civil Action Nos. 22-00228 and 22-00945, were consolidated in October 2022 and involve Exelixis patents that are different from those asserted in the MSN I litigation described above. On June 21, 2022, pursuant to a stipulation between us and MSN, the Delaware District Court entered an order that (i) MSN’s submission of its ANDA constitutes infringement of certain claims relating to U.S. Patents No. 11,091,439, 11,091,440 and 11,098,015 , if those claims are not found to be invalid, and (ii) upon approval, MSN’s commercial manufacture, use, sale or offer for sale within the U.S., and importation into the U.S., of MSN’s ANDA product prior to the expiration of U.S. Patents No. 11,091,439, 11,091,440 and 11,098,015 would also infringe certain claims of each patent, if those claims are not found to be invalid. In our MSN II complaints, we are seeking, among other remedies, equitable relief enjoining MSN from infringing this patent, as well as an order that the effective date of any FDA approval of MSN’s ANDA would be a date no earlier than the expiration of all of U.S. Patents No. 11,091,439, 11,091,440, 11,098,015 and 11,298,349, the latest of which expires on February 10, 2032. A bench trial for MSN II has been scheduled for October 2023. Teva ANDA Litigation In May 2021, we received notice letters from Teva Pharmaceutical Industries Limited, Teva Pharmaceuticals Development, Inc. and Teva Pharmaceuticals USA, Inc. (individually and collectively referred to as Teva) regarding an ANDA Teva submitted to the FDA, requesting approval to market a generic version of CABOMETYX tablets. Teva’s notice letters included a Paragraph IV certification with respect to our U.S. Patents No. 9,724,342 (formulations), 10,034,873 (methods of treatment) and 10,039,757 (methods of treatment), which are listed in the Orange Book. Teva’s notice letters did not provide a Paragraph IV certification against any additional CABOMETYX patents. On June 17, 2021, we filed a complaint in the Delaware District Court for patent infringement against Teva asserting infringement of U.S. Patents No. 9,724,342, 10,034,873 and 10,039,757 arising from Teva’s ANDA filing with the FDA. On August 27, 2021, Teva filed its answer and counterclaims to the complaint, alleging that the asserted claims of U.S. Patents No. 9,724,342, 10,034,873 and 10,039,757 are invalid and not infringed. On September 17, 2021, we filed an answer to Teva’s counterclaims. On July 29, 2022, we received notice from Teva that it had amended its ANDA to assert an additional Paragraph IV certification. As amended, Teva’s ANDA now requests approval to market a generic version of CABOMETYX tablets prior to expiration of a previously-unasserted CABOMETYX patent that is now listed in the Orange Book: U.S. Patent No. 11,298,349 (pharmaceutical composition). On September 2, 2022, we filed a complaint in the Delaware District Court for patent infringement against Teva, asserting infringement of U.S. Patent No. 11,298,349 arising from Teva’s amended ANDA filing with the FDA. We are seeking, among other relief, an order that the effective date of any FDA approval of Teva’s ANDA be a date no earlier than the expiration of all of U.S. Patents No. 9,724,342, 10,034,873, 10,039,757 and 11,298,349, the latest of which expires on July 9, 2033, and equitable relief enjoining Teva from infringing these patents. On September 30, 2022, the parties filed a stipulation to consolidate the two lawsuits, numbered Civil Action Nos. 21-00871 and 22-01168, and to stay all proceedings, which was granted by the Delaware District Court on October 3, 2022. Following a similar order granted by the Delaware District Court on February 9, 2022 to stay all proceedings with respect to Civil Action No. 21-00871, this case remained administratively closed, and Civil Action No. 22-01168 was administratively closed on October 3, 2022. The sale of any generic version of CABOMETYX earlier than its patent expiration could significantly decrease our revenues derived from the U.S. sales of CABOMETYX and thereby materially harm our business, financial condition and results of operations. It is not possible at this time to determine the likelihood of an unfavorable outcome or estimate of the amount or range of any potential loss. We may also from time to time become a party or subject to various other legal proceedings and claims, either asserted or unasserted, which arise in the ordinary course of business. Some of these proceedings have involved, and may involve in the future, claims that are subject to substantial uncertainties and unascertainable damages. |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2022 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | SUBSEQUENT EVENTS In November 2022, we entered into an agreement with Cybrexa Therapeutics, LLC (Cybrexa), which provides us the right to acquire CBX-12 (alphalex™ exatecan), a clinical-stage peptide-drug conjugate (PDC) that utilizes Cybrexa’s proprietary alphalex technology to enhance delivery of exatecan to tumor cells. Under the terms of the agreement, we will pay an upfront fee of $60.0 million for a warrant entitling us to the right to acquire the Cybrexa affiliate that controls CBX-12 and related assets, and to fund certain development and manufacturing expenses incurred by Cybrexa to advance CBX-12 during the warrant period. Cybrexa will continue the development of CBX-12 according to an agreed development plan, including phase 1 studies, and may be eligible to receive up to $65.0 million in additional development milestone payments, during the warrant period. We may exercise the warrant for up to $300.0 million based upon our evaluation of a pre-specified clinical data package to be delivered by Cybrexa. Following exercise of the warrant, Cybrexa would be eligible to receive up to $277.5 million in additional payments upon achievement of further development, regulatory and commercial milestones. Sairopa, B.V. (Sairopa) In November 2022, we entered into an exclusive option and license agreement with Sairopa, B.V. (Sairopa). Under the terms of the agreement, we will make an upfront payment of $40.0 million for an option to obtain an exclusive, worldwide license to develop and commercialize ADU-1805 and other anti-SIRPα antibodies, and for certain expenses to be incurred by Sairopa in conducting phase 1 clinical studies of ADU-1805. Sairopa is eligible to receive additional development milestone payments during the option period totaling up to $97.5 million. Following the completion of the clinical studies, we may exercise the option for $225.0 million based upon our evaluation of a pre-specified clinical data package to be delivered by Sairopa. Following the exercise of the option, Sairopa would be eligible to receive up to $465.0 million in additional development, commercial, and net sales milestone payments, as well as tiered royalties on future net sales of products. |
Organization and Summary of S_2
Organization and Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Basis of Consolidation | The accompanying 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 U.S. 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 our financial statements for the periods presented have been included. Operating results for the nine months ended September 30, 2022 are not necessarily indicative of the results that may be expected for the year ending December 31, 2022 or for any future period. The accompanying Condensed Consolidated Financial Statements and Notes thereto should be read in conjunction with our Consolidated Financial Statements and Notes included in Part II, Item 8 of our Annual Report on Form 10-K for the fiscal year ended December 31, 2021, filed with the SEC on February 18, 2022 (Fiscal 2021 Form 10-K). |
Fiscal Period | We have adopted a 52- or 53-week fiscal year policy that generally ends on the Friday closest to December 31 st |
Segment Information | We operate in one business segment that focuses on the discovery, development and commercialization of new medicines for difficult-to-treat cancers. Our Chief Executive Officer, as the chief operating decision-maker, manages and allocates resources to our operations on a total consolidated basis. Consistent with this decision-making process, our Chief Executive Officer uses consolidated, single-segment financial information for purposes of evaluating performance, forecasting future period financial results, allocating resources and setting incentive targets. |
Use of Estimates | The preparation of the accompanying Condensed Consolidated Financial Statements conforms to accounting principles generally accepted in the U.S., which requires management to make judgments, estimates and assumptions that affect the reported amounts of assets, liabilities, equity, revenues and expenses, and related disclosures. On an ongoing basis, we evaluate our significant estimates. 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. |
Reclassifications | Certain prior period amounts in the accompanying Condensed Consolidated Financial Statements have been reclassified to conform to the current period presentation. Such reclassifications did not impact previously reported total revenues, income from operations, net income, total assets, total liabilities or total stockholders’ equity. |
Recently Adopted Accounting Pronouncements and Recent Accounting Pronouncements Not Yet Adopted | Recently Adopted Accounting Pronouncements There were no new accounting pronouncements adopted by us since the filing of our Fiscal 2021 Form 10-K, which could have a significant effect on our Condensed Consolidated Financial Statements. Recent Accounting Pronouncements Not Yet Adopted There were no new accounting pronouncements issued since the filing of our Fiscal 2021 Form 10-K, which could have a significant effect on our Condensed Consolidated Financial Statements. |
Revenues | Total revenues include net product revenues attributed to geographic regions based on the ship-to location and license and collaboration services revenues attributed to geographic regions based on the location of our collaboration partners’ headquarters. Net product revenues and license revenues are recorded in accordance with ASC Topic 606, Revenue from Contracts with Customers (Topic 606). License revenues include the recognition of the portion of milestone payments allocated to the transfer of intellectual property licenses for which it had become probable in the current period that the milestone would be achieved and a significant reversal of revenues would not occur, as well as royalty revenues and our share of profits under our collaboration agreement with Genentech. Collaboration services revenues were recorded in accordance with ASU 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606 and by analogy to Topic 606. Collaboration services revenues include the recognition of deferred revenues for the portion of upfront and milestone payments allocated to our research and development services performance obligations, development cost reimbursements earned under our collaboration agreements, product supply revenues, net of product supply costs, and the royalties we paid on sales of products containing cabozantinib by our collaboration partners. The allowance for chargebacks, discounts for prompt payment and other are recorded as a reduction of trade receivables, net, and the remaining reserves are recorded as rebates and fees due to customers in the accompanying Condensed Consolidated Balance Sheets. Contract Assets and Liabilities We receive payments from our collaboration partners based on billing schedules established in each contract. Amounts are recorded as accounts receivable when our right to consideration is unconditional. We may also recognize revenue in advance of the contractual billing schedule, and such amounts are recorded as a contract asset when recognized. We may be required to defer recognition of revenue for upfront and milestone payments until we perform our obligations under these arrangements, and such amounts are recorded as deferred revenue upon receipt or when due. For those contracts that have multiple performance obligations, contract assets and liabilities are reported on a net basis at the contract level. Contract assets are primarily related to Ipsen Pharma SAS (Ipsen) and contract liabilities are primarily related to deferred revenues from Takeda Pharmaceutical Company Limited (Takeda). |
Revenues (Tables)
Revenues (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Revenue from Contract with Customer [Abstract] | |
Schedule of Disaggregation of Revenue | Revenues consisted of the following (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Product revenues: Gross product revenues $ 496,141 $ 357,462 $ 1,427,451 $ 1,051,871 Discounts and allowances (129,659) (94,345) (403,627) (277,294) Net product revenues 366,482 263,117 1,023,824 774,577 Collaboration revenues: License revenues 34,384 49,694 123,977 116,862 Collaboration services revenues 10,872 15,612 39,344 92,391 Total collaboration revenues 45,256 65,306 163,321 209,253 Total revenues $ 411,738 $ 328,423 $ 1,187,145 $ 983,830 Net product revenues by product were as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 CABOMETYX $ 361,385 $ 259,791 $ 1,003,356 $ 759,000 COMETRIQ 5,097 3,326 20,468 15,577 Net product revenues $ 366,482 $ 263,117 $ 1,023,824 $ 774,577 |
Schedule of Concentration Risks | The percentage of total revenues by customer who individually accounted for 10% or more of our total revenues were as follows: Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Affiliates of McKesson Corporation 18 % 15 % 18 % 15 % Affiliates of CVS Health Corporation 19 % 16 % 17 % 15 % Affiliates of AmerisourceBergen Corporation 18 % 16 % 16 % 14 % Ipsen Pharma SAS 8 % 12 % 11 % 17 % Accredo Health, Incorporated 11 % 9 % 10 % 8 % The percentage of trade receivables by customer who individually accounted for 10% or more of our trade receivables were as follows: September 30, 2022 December 31, 2021 Affiliates of McKesson Corporation 23 % 10 % Ipsen Pharma SAS 21 % 50 % Affiliates of AmerisourceBergen Corporation 20 % 11 % Affiliates of CVS Health Corporation 15 % 9 % |
Schedule of Revenues Disaggregated by Geographic Region | Revenues by geographic region were as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 U.S. $ 369,480 $ 266,436 $ 1,033,160 $ 783,583 Europe 34,818 38,095 131,585 162,822 Japan 7,440 23,892 22,400 37,425 Total revenues $ 411,738 $ 328,423 $ 1,187,145 $ 983,830 |
Schedule of Activities and Ending Reserve Balances for Significant Categories of Discounts and Allowances | The activities and ending reserve balances for each significant category of discounts and allowances, which constitute variable consideration, were as follows (in thousands): Chargebacks, Discounts for Prompt Payment and Other Other Customer Credits/Fees and Co-pay Assistance Rebates Total Balance at December 31, 2021 $ 14,625 $ 8,875 $ 24,825 $ 48,325 Provision related to sales made in: Current period 261,143 36,847 105,280 403,270 Prior periods 632 (169) (106) 357 Payments and customer credits issued (255,002) (32,765) (98,996) (386,763) Balance at September 30, 2022 $ 21,398 $ 12,788 $ 31,003 $ 65,189 |
Schedule of Other Assets and Other Liabilities | Contract assets and liabilities were as follows (in thousands): September 30, 2022 December 31, 2021 Contract assets (1) $ 364 $ 1,665 Contract liabilities: Current portion (2) $ 6,932 $ 7,814 Long-term portion (3) 6,491 8,739 Total contract liabilities $ 13,423 $ 16,553 ____________________ (1) Presented in other long-term assets in the accompanying Condensed Consolidated Balance Sheets. (2) Presented in other current liabilities in the accompanying Condensed Consolidated Balance Sheets. (3) Presented in the long-term portion of deferred revenues in the accompanying Condensed Consolidated Balance Sheets |
Collaboration Agreements And _2
Collaboration Agreements And Business Development Activities (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedule of Collaborative Revenues Under Collaboration Agreement | Revenues under the collaboration agreement with Ipsen were as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 License revenues $ 27,607 $ 25,139 $ 103,389 $ 81,246 Collaboration services revenues 7,211 12,956 28,196 81,576 Total $ 34,818 $ 38,095 $ 131,585 $ 162,822 Revenues under the collaboration agreement with Takeda were as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 License revenues $ 2,690 $ 20,078 $ 7,755 $ 23,476 Collaboration services revenues 3,661 2,656 11,148 10,815 Total $ 6,351 $ 22,734 $ 18,903 $ 34,291 License revenues under the collaboration agreement with Genentech were as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Profits on U.S. commercialization $ 1,504 $ 1,743 $ 5,325 $ 5,697 Royalty revenues on ex-U.S. sales $ 1,494 $ 1,576 $ 4,011 $ 3,309 |
Cash and Investments (Tables)
Cash and Investments (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of Reconciliation of Cash, Cash Equivalents, and Restricted Cash | A reconciliation of cash, cash equivalents, and restricted cash equivalents reported in the accompanying Condensed Consolidated Balance Sheets to the amount reported within the accompanying Condensed Consolidated Statements of Cash Flows was as follows (in thousands): September 30, 2022 December 31, 2021 Cash and cash equivalents $ 675,286 $ 647,169 Restricted cash equivalents included in other long-term assets 1,482 16,722 Cash, cash equivalents, and restricted cash equivalents as reported in the accompanying Condensed Consolidated Statements of Cash Flows $ 676,768 $ 663,891 |
Schedule of Reconciliation of Cash, Cash Equivalents, and Restricted Cash | A reconciliation of cash, cash equivalents, and restricted cash equivalents reported in the accompanying Condensed Consolidated Balance Sheets to the amount reported within the accompanying Condensed Consolidated Statements of Cash Flows was as follows (in thousands): September 30, 2022 December 31, 2021 Cash and cash equivalents $ 675,286 $ 647,169 Restricted cash equivalents included in other long-term assets 1,482 16,722 Cash, cash equivalents, and restricted cash equivalents as reported in the accompanying Condensed Consolidated Statements of Cash Flows $ 676,768 $ 663,891 |
Schedule of Investments by Security Type | Cash, cash equivalents, restricted cash equivalents and investments consisted of the following (in thousands): September 30, 2022 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Debt securities available-for-sale: Commercial paper $ 874,220 $ — $ (364) $ 873,856 Corporate bonds 633,617 — (15,495) 618,122 U.S. Treasury and government-sponsored enterprises 307,494 — (6,157) 301,337 Municipal bonds 16,565 — (312) 16,253 Total debt securities available-for-sale 1,831,896 — (22,328) 1,809,568 Cash 113,492 — — 113,492 Money market funds 62,968 — — 62,968 Certificates of deposit 114,181 — — 114,181 Total cash, cash equivalents, restricted cash equivalents and investments $ 2,122,537 $ — $ (22,328) $ 2,100,209 December 31, 2021 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Debt securities available-for-sale: Commercial paper $ 945,801 $ 42 $ (2) $ 945,841 Corporate bonds 541,774 876 (1,672) 540,978 U.S. Treasury and government-sponsored enterprises 33,965 1 (21) 33,945 Municipal bonds 12,924 15 (35) 12,904 Total debt securities available-for-sale 1,534,464 934 (1,730) 1,533,668 Cash 135,653 — — 135,653 Money market funds 66,531 — — 66,531 Certificates of deposit 119,056 — — 119,056 Total cash, cash equivalents, restricted cash equivalents and investments $ 1,855,704 $ 934 $ (1,730) $ 1,854,908 |
Schedule of Fair Value and Gross Unrealized Losses of Investments Available-for-Sale in an Unrealized Loss Position | The fair value and gross unrealized losses on debt securities available-for-sale in an unrealized loss position were as follows (in thousands): September 30, 2022 Fair Value Gross Unrealized Losses Corporate bonds $ 613,122 $ (15,495) U.S. Treasury and government-sponsored enterprises 301,337 (6,157) Commercial paper 36,636 (364) Municipal bonds 16,073 (312) Total $ 967,168 $ (22,328) December 31, 2021 Fair Value Gross Unrealized Losses Corporate bonds $ 385,053 $ (1,672) Commercial paper 43,290 (2) U.S. Treasury and government-sponsored enterprises 18,962 (21) Municipal bonds 7,475 (35) Total $ 454,780 $ (1,730) |
Schedule of Fair Value of Cash Equivalents and Investments by Contractual Maturity | The fair value of debt securities available-for-sale by contractual maturity was as follows (in thousands): September 30, 2022 December 31, 2021 Maturing in one year or less $ 1,260,834 $ 1,168,256 Maturing after one year through five years 548,734 365,412 Total debt securities available-for-sale $ 1,809,568 $ 1,533,668 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Schedule of Fair Value of Financial Assets Measured on a Recurring Basis | The classifications within the fair value hierarchy of our financial assets that were measured and recorded at fair value on a recurring basis were as follows (in thousands): September 30, 2022 Level 1 Level 2 Total Commercial paper $ — $ 873,856 $ 873,856 Corporate bonds — 618,122 618,122 U.S. Treasury and government-sponsored enterprises — 301,337 301,337 Municipal bonds — 16,253 16,253 Total debt securities available-for-sale — 1,809,568 1,809,568 Money market funds 62,968 — 62,968 Certificates of deposit — 114,181 114,181 Total financial assets carried at fair value $ 62,968 $ 1,923,749 $ 1,986,717 December 31, 2021 Level 1 Level 2 Total Commercial paper $ — $ 945,841 $ 945,841 Corporate bonds — 540,978 540,978 U.S. Treasury and government-sponsored enterprises — 33,945 33,945 Municipal bonds — 12,904 12,904 Total debt securities available-for-sale — 1,533,668 1,533,668 Money market funds 66,531 — 66,531 Certificates of deposit — 119,056 119,056 Total financial assets carried at fair value $ 66,531 $ 1,652,724 $ 1,719,255 |
Inventory (Tables)
Inventory (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory | Inventory consisted of the following (in thousands): September 30, 2022 December 31, 2021 Raw materials $ 9,447 $ 8,867 Work in process 39,380 27,717 Finished goods 11,325 12,927 Total $ 60,152 $ 49,511 Balance Sheet classification: Current portion included in inventory $ 26,711 $ 27,493 Long-term portion included in other long-term assets 33,441 22,018 Total $ 60,152 $ 49,511 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Allocated Employee Stock-Based Compensation Expense | We allocated the stock-based compensation expense for our equity incentive plans and our Employee Stock Purchase Plan (ESPP) as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Research and development $ 16,438 $ 11,487 $ 34,886 $ 37,550 Selling, general and administrative 20,899 22,479 46,832 59,104 Total stock-based compensation expense $ 37,337 $ 33,966 $ 81,718 $ 96,654 Stock-based compensation for each type of award under our equity incentive plans and ESPP were as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Stock options $ 3,299 $ 4,607 $ 10,470 $ 15,203 Restricted stock units 22,233 13,721 54,234 40,802 Performance stock units 11,331 14,971 14,621 37,616 ESPP 474 667 2,393 3,033 Total stock-based compensation expense $ 37,337 $ 33,966 $ 81,718 $ 96,654 |
Schedule of Share-Based Payment Award, Equity Instruments Other Than Options, Valuation Assumptions | We used a Monte Carlo simulation model and the following assumptions to determine the grant date fair value of $33.17 per share for the TSR-based RSUs: Fair value of the Company’s common stock on grant date $ 20.70 Expected volatility 46.85 % Risk-free interest rate 1.59 % Dividend yield — % |
Net Income Per Share (Tables)
Net Income Per Share (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Earnings Per Share [Abstract] | |
Schedule of Computation of Basic and Diluted Net Income Per Share | Net income per share - basic and diluted, were computed as follows (in thousands, except per share amounts): Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Numerator: Net income $ 73,210 $ 38,204 $ 212,455 $ 135,897 Denominator: Weighted-average common shares outstanding — basic 322,148 315,380 320,949 313,990 Dilutive securities 2,918 6,642 3,471 8,094 Weighted-average common shares outstanding — diluted 325,066 322,022 324,420 322,084 Net income per share — basic $ 0.23 $ 0.12 $ 0.66 $ 0.43 Net income per share — diluted $ 0.23 $ 0.12 $ 0.65 $ 0.42 |
Schedule of Potential Shares of Common Stock Not Included in the Computation of Diluted Net Income Per Share | The weighted-average potential common shares excluded from our calculation were as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Anti-dilutive securities and contingently issuable shares excluded 15,059 20,346 15,311 14,213 |
Organization and Summary of S_3
Organization and Summary of Significant Accounting Policies (Details) | 9 Months Ended |
Sep. 30, 2022 country product segment | |
Organization And Summary Of Significant Policies [Line Items] | |
Number of countries with drug approval, excluding the u.s. | country | 62 |
Number of business segments | segment | 1 |
Resulting from discovery efforts | |
Organization And Summary Of Significant Policies [Line Items] | |
Number of products that entered in the commercial marketplace | 4 |
Products derived from other compounds | |
Organization And Summary Of Significant Policies [Line Items] | |
Number of products that entered in the commercial marketplace | 2 |
Revenues - Revenues by Disaggre
Revenues - Revenues by Disaggregated Category (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Oct. 01, 2021 | Sep. 30, 2022 | Oct. 01, 2021 | |
Disaggregation of Revenue [Line Items] | ||||
Total revenues | $ 411,738 | $ 328,423 | $ 1,187,145 | $ 983,830 |
Gross product revenues | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenues | 496,141 | 357,462 | 1,427,451 | 1,051,871 |
Discounts and allowances | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenues | (129,659) | (94,345) | (403,627) | (277,294) |
Net product revenues | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenues | 366,482 | 263,117 | 1,023,824 | 774,577 |
License revenues | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenues | 34,384 | 49,694 | 123,977 | 116,862 |
Collaboration services revenues | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenues | 10,872 | 15,612 | 39,344 | 92,391 |
Total collaboration revenues | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenues | $ 45,256 | $ 65,306 | $ 163,321 | $ 209,253 |
Revenues - Revenues Disaggregat
Revenues - Revenues Disaggregated by Concentration Risks (Details) - Customer Concentration Risk | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2022 | Oct. 01, 2021 | Sep. 30, 2022 | Oct. 01, 2021 | Dec. 31, 2021 | |
Affiliates of McKesson Corporation | Revenue | |||||
Concentration Risk [Line Items] | |||||
Percent of total revenues | 18% | 15% | 18% | 15% | |
Affiliates of McKesson Corporation | Accounts Receivable | |||||
Concentration Risk [Line Items] | |||||
Percent of total revenues | 23% | 10% | |||
Affiliates of CVS Health Corporation | Revenue | |||||
Concentration Risk [Line Items] | |||||
Percent of total revenues | 19% | 16% | 17% | 15% | |
Affiliates of CVS Health Corporation | Accounts Receivable | |||||
Concentration Risk [Line Items] | |||||
Percent of total revenues | 15% | 9% | |||
Affiliates of AmerisourceBergen Corporation | Revenue | |||||
Concentration Risk [Line Items] | |||||
Percent of total revenues | 18% | 16% | 16% | 14% | |
Affiliates of AmerisourceBergen Corporation | Accounts Receivable | |||||
Concentration Risk [Line Items] | |||||
Percent of total revenues | 20% | 11% | |||
Ipsen Pharma SAS | Revenue | |||||
Concentration Risk [Line Items] | |||||
Percent of total revenues | 8% | 12% | 11% | 17% | |
Ipsen Pharma SAS | Accounts Receivable | |||||
Concentration Risk [Line Items] | |||||
Percent of total revenues | 21% | 50% | |||
Accredo Health, Incorporated | Revenue | |||||
Concentration Risk [Line Items] | |||||
Percent of total revenues | 11% | 9% | 10% | 8% |
Revenues - Revenues Disaggreg_2
Revenues - Revenues Disaggregated by Geographic Region (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Oct. 01, 2021 | Sep. 30, 2022 | Oct. 01, 2021 | |
Disaggregation of Revenue [Line Items] | ||||
Total revenues | $ 411,738 | $ 328,423 | $ 1,187,145 | $ 983,830 |
U.S. | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenues | 369,480 | 266,436 | 1,033,160 | 783,583 |
Europe | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenues | 34,818 | 38,095 | 131,585 | 162,822 |
Japan | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenues | $ 7,440 | $ 23,892 | $ 22,400 | $ 37,425 |
Revenues - Net Product Revenues
Revenues - Net Product Revenues Disaggregated by Product (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Oct. 01, 2021 | Sep. 30, 2022 | Oct. 01, 2021 | |
Disaggregation of Revenue [Line Items] | ||||
Net product revenues | $ 411,738 | $ 328,423 | $ 1,187,145 | $ 983,830 |
Net product revenues | ||||
Disaggregation of Revenue [Line Items] | ||||
Net product revenues | 366,482 | 263,117 | 1,023,824 | 774,577 |
CABOMETYX | ||||
Disaggregation of Revenue [Line Items] | ||||
Net product revenues | 361,385 | 259,791 | 1,003,356 | 759,000 |
COMETRIQ | ||||
Disaggregation of Revenue [Line Items] | ||||
Net product revenues | $ 5,097 | $ 3,326 | $ 20,468 | $ 15,577 |
Revenues - Activities and Endin
Revenues - Activities and Ending Reserve Balances for Significant Categories of Discounts and Allowances (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2022 USD ($) | |
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | |
Balance at December 31, 2021 | $ 48,325 |
Provision related to sales made in: | |
Current period | 403,270 |
Prior periods | 357 |
Payments and customer credits issued | (386,763) |
Balance at September 30, 2022 | 65,189 |
Chargebacks, Discounts for Prompt Payment and Other | |
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | |
Balance at December 31, 2021 | 14,625 |
Provision related to sales made in: | |
Current period | 261,143 |
Prior periods | 632 |
Payments and customer credits issued | (255,002) |
Balance at September 30, 2022 | 21,398 |
Other Customer Credits/Fees and Co-pay Assistance | |
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | |
Balance at December 31, 2021 | 8,875 |
Provision related to sales made in: | |
Current period | 36,847 |
Prior periods | (169) |
Payments and customer credits issued | (32,765) |
Balance at September 30, 2022 | 12,788 |
Rebates | |
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | |
Balance at December 31, 2021 | 24,825 |
Provision related to sales made in: | |
Current period | 105,280 |
Prior periods | (106) |
Payments and customer credits issued | (98,996) |
Balance at September 30, 2022 | $ 31,003 |
Revenues - Contract Assets and
Revenues - Contract Assets and Liabilities (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2022 | Oct. 01, 2021 | Sep. 30, 2022 | Oct. 01, 2021 | Dec. 31, 2021 | |
Contract assets: | |||||
Contract assets | $ 364 | $ 364 | $ 1,665 | ||
Contract liabilities: | |||||
Current portion | 6,932 | 6,932 | 7,814 | ||
Long-term portion | 6,491 | 6,491 | 8,739 | ||
Total contract liabilities | 13,423 | 13,423 | $ 16,553 | ||
Contract revenue recognized, including revenue from deferred revenue beginning balance | 6,600 | $ 6,800 | |||
Revenues recognized for performance obligations satisfied in previous periods | 33,900 | $ 48,400 | 125,000 | $ 116,200 | |
Takeda and Ispen | |||||
Contract liabilities: | |||||
Remaining performance obligation | $ 83,100 | $ 83,100 |
Collaboration Agreements And _3
Collaboration Agreements And Business Development Activities - Collaboration Revenues under the Collaboration Agreement with Ipsen (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Oct. 01, 2021 | Sep. 30, 2022 | Oct. 01, 2021 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Total revenues | $ 411,738 | $ 328,423 | $ 1,187,145 | $ 983,830 |
Collaborative Arrangement with Ipsen | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Total revenues | 34,818 | 38,095 | 131,585 | 162,822 |
License revenues | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Total revenues | 34,384 | 49,694 | 123,977 | 116,862 |
License revenues | Collaborative Arrangement with Ipsen | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Total revenues | 27,607 | 25,139 | 103,389 | 81,246 |
Collaboration services revenues | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Total revenues | 10,872 | 15,612 | 39,344 | 92,391 |
Collaboration services revenues | Collaborative Arrangement with Ipsen | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Total revenues | $ 7,211 | $ 12,956 | $ 28,196 | $ 81,576 |
Collaboration Agreements And _4
Collaboration Agreements And Business Development Activities - Ipsen Collaboration Narrative (Details) - Collaborative Arrangement with Ipsen $ in Millions | 9 Months Ended |
Sep. 30, 2022 USD ($) milestone | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |
Amount of revenues recognized included in the beginning contract liability balance | $ 25.8 |
Number of regulatory milestone | milestone | 2 |
Milestone revenue recognized | $ 27 |
Remaining performance obligation | $ 49.3 |
Collaboration Agreements And _5
Collaboration Agreements And Business Development Activities - Collaboration Revenues under the Collaboration Agreement with Takeda (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Oct. 01, 2021 | Sep. 30, 2022 | Oct. 01, 2021 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Total revenues | $ 411,738 | $ 328,423 | $ 1,187,145 | $ 983,830 |
Collaborative Arrangement with Takeda | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Total revenues | 6,351 | 22,734 | 18,903 | 34,291 |
License revenues | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Total revenues | 34,384 | 49,694 | 123,977 | 116,862 |
License revenues | Collaborative Arrangement with Takeda | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Total revenues | 2,690 | 20,078 | 7,755 | 23,476 |
Collaboration services revenues | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Total revenues | 10,872 | 15,612 | 39,344 | 92,391 |
Collaboration services revenues | Collaborative Arrangement with Takeda | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Total revenues | $ 3,661 | $ 2,656 | $ 11,148 | $ 10,815 |
Collaboration Agreements And _6
Collaboration Agreements And Business Development Activities - Takeda Collaboration Narrative (Details) $ in Millions | Sep. 30, 2022 USD ($) |
Collaborative Arrangement with Takeda | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |
Remaining performance obligation | $ 33.8 |
Collaboration Agreements And _7
Collaboration Agreements And Business Development Activities - GSK Narrative (Details) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Oct. 01, 2021 | Sep. 30, 2022 | Oct. 01, 2021 | |
Collaboration Agreement with GlaxoSmithKline | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Percent of royalty on net sale | 3% | |||
Royal Pharma | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Royalty expense | $ 14.9 | $ 11.5 | $ 42.6 | $ 33.7 |
Collaboration Agreements And _8
Collaboration Agreements And Business Development Activities- Royalty Revenues under the Collaboration Agreement with Genentech (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Oct. 01, 2021 | Sep. 30, 2022 | Oct. 01, 2021 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Royalty revenues on ex-U.S. sales | $ 411,738 | $ 328,423 | $ 1,187,145 | $ 983,830 |
Collaborative Arrangement with Genentech | Cotellic | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Profits on U.S. commercialization | 1,504 | 1,743 | 5,325 | 5,697 |
Royalty revenues on ex-U.S. sales | $ 1,494 | $ 1,576 | $ 4,011 | $ 3,309 |
Collaboration Agreements And _9
Collaboration Agreements And Business Development Activities - Research Collaborations and In-Licensing Arrangements Narrative (Details) - USD ($) $ in Millions | 1 Months Ended | ||
Jul. 31, 2022 | Jun. 30, 2022 | Sep. 30, 2022 | |
Collaboration Agreement With BioInvent International AB (BioInvent) | |||
Asset Acquisition [Line Items] | |||
Collaborative arrangement, upfront payment | $ 25 | ||
Collaboration Agreement With Ryvu Therapeutics S.A. (Ryvu) | |||
Asset Acquisition [Line Items] | |||
Collaborative arrangement, upfront payment | $ 3 | ||
Research Collaborations, In-Licensing Arrangements and Other Business Development Activities | |||
Asset Acquisition [Line Items] | |||
Collaborative arrangement, maximum aggregate development milestone payments | $ 364.7 | ||
Collaborative arrangement, maximum aggregate regulatory milestone payments | 453.4 | ||
Collaborative arrangement, rights and obligations, maximum aggregate commercial milestone payments | $ 2,443.4 |
Cash and Investments - Reconcil
Cash and Investments - Reconciliation of Cash, Cash Equivalents, and Restricted Cash (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 | Oct. 01, 2021 | Jan. 01, 2021 |
Cash and Cash Equivalents [Abstract] | ||||
Cash and cash equivalents | $ 675,286 | $ 647,169 | ||
Restricted cash equivalents included in other long-term assets | 1,482 | 16,722 | ||
Cash, cash equivalents, and restricted cash equivalents as reported in the accompanying Condensed Consolidated Statements of Cash Flows | $ 676,768 | $ 663,891 | $ 598,488 | $ 320,772 |
Cash and Investments - Narrativ
Cash and Investments - Narrative (Details) | Sep. 30, 2022 USD ($) bond investment | Dec. 31, 2021 USD ($) investment | Oct. 01, 2021 USD ($) |
Debt Securities, Available-for-sale [Line Items] | |||
Interest receivable | $ 4,800,000 | $ 2,900,000 | |
Number of investments in an unrealized loss position | investment | 276 | 133 | |
Debt securities, available-for-sale, continuous unrealized loss position, 12 months or longer | $ 64,000,000 | ||
Accumulated loss | 2,400,000 | ||
Allowance for credit losses | $ 0 | $ 0 | |
Corporate bonds | |||
Debt Securities, Available-for-sale [Line Items] | |||
Number of bond securities | bond | 25 | ||
Municipal bonds | |||
Debt Securities, Available-for-sale [Line Items] | |||
Number of bond securities | bond | 1 |
Cash and Investments - Investme
Cash and Investments - Investments by Security Type (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Debt securities available-for-sale: | ||
Amortized Cost | $ 1,831,896 | $ 1,534,464 |
Gross Unrealized Gains | 0 | 934 |
Gross Unrealized Losses | (22,328) | (1,730) |
Fair Value | 1,809,568 | 1,533,668 |
Cash, Cash Equivalents, Restricted Cash and Restricted Cash Equivalents | ||
Amortized Cost | 2,122,537 | 1,855,704 |
Gross Unrealized Gains | 0 | 934 |
Gross Unrealized Losses | (22,328) | (1,730) |
Fair Value | 2,100,209 | 1,854,908 |
Commercial paper | ||
Debt securities available-for-sale: | ||
Amortized Cost | 874,220 | 945,801 |
Gross Unrealized Gains | 0 | 42 |
Gross Unrealized Losses | (364) | (2) |
Fair Value | 873,856 | 945,841 |
Corporate bonds | ||
Debt securities available-for-sale: | ||
Amortized Cost | 633,617 | 541,774 |
Gross Unrealized Gains | 0 | 876 |
Gross Unrealized Losses | (15,495) | (1,672) |
Fair Value | 618,122 | 540,978 |
U.S. Treasury and government-sponsored enterprises | ||
Debt securities available-for-sale: | ||
Amortized Cost | 307,494 | 33,965 |
Gross Unrealized Gains | 0 | 1 |
Gross Unrealized Losses | (6,157) | (21) |
Fair Value | 301,337 | 33,945 |
Municipal bonds | ||
Debt securities available-for-sale: | ||
Amortized Cost | 16,565 | 12,924 |
Gross Unrealized Gains | 0 | 15 |
Gross Unrealized Losses | (312) | (35) |
Fair Value | 16,253 | 12,904 |
Cash | ||
Cash, Cash Equivalents, Restricted Cash and Restricted Cash Equivalents | ||
Amortized Cost | 113,492 | 135,653 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | 113,492 | 135,653 |
Money market funds | ||
Cash, Cash Equivalents, Restricted Cash and Restricted Cash Equivalents | ||
Amortized Cost | 62,968 | 66,531 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | 62,968 | 66,531 |
Certificates of deposit | ||
Cash, Cash Equivalents, Restricted Cash and Restricted Cash Equivalents | ||
Amortized Cost | 114,181 | 119,056 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | $ 114,181 | $ 119,056 |
Cash and Investments - Fair Val
Cash and Investments - Fair Value and Gross Unrealized Losses of Investments Available-for-Sale in an Unrealized Loss Position (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Debt Securities, Available-for-sale, Unrealized Loss Position, Accumulated Loss [Abstract] | ||
Fair Value | $ 967,168 | $ 454,780 |
Gross Unrealized Losses | (22,328) | (1,730) |
Corporate bonds | ||
Debt Securities, Available-for-sale, Unrealized Loss Position, Accumulated Loss [Abstract] | ||
Fair Value | 613,122 | 385,053 |
Gross Unrealized Losses | (15,495) | (1,672) |
U.S. Treasury and government-sponsored enterprises | ||
Debt Securities, Available-for-sale, Unrealized Loss Position, Accumulated Loss [Abstract] | ||
Fair Value | 301,337 | 18,962 |
Gross Unrealized Losses | (6,157) | (21) |
Commercial paper | ||
Debt Securities, Available-for-sale, Unrealized Loss Position, Accumulated Loss [Abstract] | ||
Fair Value | 36,636 | 43,290 |
Gross Unrealized Losses | (364) | (2) |
Municipal bonds | ||
Debt Securities, Available-for-sale, Unrealized Loss Position, Accumulated Loss [Abstract] | ||
Fair Value | 16,073 | 7,475 |
Gross Unrealized Losses | $ (312) | $ (35) |
Cash and Investments - Fair V_2
Cash and Investments - Fair Value of Cash Equivalents and Investments by Contractual Maturity (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Investments, Debt and Equity Securities [Abstract] | ||
Maturing in one year or less | $ 1,260,834 | $ 1,168,256 |
Maturing after one year through five years | 548,734 | 365,412 |
Total debt securities available-for-sale | $ 1,809,568 | $ 1,533,668 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total debt securities available-for-sale | $ 1,809,568 | $ 1,533,668 |
Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total debt securities available-for-sale | 1,809,568 | 1,533,668 |
Total financial assets carried at fair value | 1,986,717 | 1,719,255 |
Level 1 | Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total debt securities available-for-sale | 0 | 0 |
Total financial assets carried at fair value | 62,968 | 66,531 |
Level 2 | Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total debt securities available-for-sale | 1,809,568 | 1,533,668 |
Total financial assets carried at fair value | 1,923,749 | 1,652,724 |
Commercial paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total debt securities available-for-sale | 873,856 | 945,841 |
Commercial paper | Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total debt securities available-for-sale | 873,856 | 945,841 |
Commercial paper | Level 1 | Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total debt securities available-for-sale | 0 | 0 |
Commercial paper | Level 2 | Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total debt securities available-for-sale | 873,856 | 945,841 |
Corporate bonds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total debt securities available-for-sale | 618,122 | 540,978 |
Corporate bonds | Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total debt securities available-for-sale | 618,122 | 540,978 |
Corporate bonds | Level 1 | Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total debt securities available-for-sale | 0 | 0 |
Corporate bonds | Level 2 | Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total debt securities available-for-sale | 618,122 | 540,978 |
U.S. Treasury and government-sponsored enterprises | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total debt securities available-for-sale | 301,337 | 33,945 |
U.S. Treasury and government-sponsored enterprises | Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total debt securities available-for-sale | 301,337 | 33,945 |
U.S. Treasury and government-sponsored enterprises | Level 1 | Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total debt securities available-for-sale | 0 | 0 |
U.S. Treasury and government-sponsored enterprises | Level 2 | Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total debt securities available-for-sale | 301,337 | 33,945 |
Municipal bonds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total debt securities available-for-sale | 16,253 | 12,904 |
Municipal bonds | Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total debt securities available-for-sale | 16,253 | 12,904 |
Municipal bonds | Level 1 | Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total debt securities available-for-sale | 0 | 0 |
Municipal bonds | Level 2 | Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total debt securities available-for-sale | 16,253 | 12,904 |
Money market funds | Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 62,968 | 66,531 |
Money market funds | Level 1 | Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 62,968 | 66,531 |
Money market funds | Level 2 | Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 0 | 0 |
Certificates of deposit | Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 114,181 | 119,056 |
Certificates of deposit | Level 1 | Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 0 | 0 |
Certificates of deposit | Level 2 | Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | $ 114,181 | $ 119,056 |
Fair Value Measurements - Narra
Fair Value Measurements - Narratives (Details) - Foreign Exchange Forward € in Millions, $ in Millions | 9 Months Ended | ||
Sep. 30, 2022 USD ($) | Oct. 01, 2021 USD ($) | Sep. 30, 2022 EUR (€) forward_contract | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Number of contract | forward_contract | 1 | ||
Derivative notional amount | € | € 10 | ||
Derivative term of contract | 3 months | ||
Gain on derivative instruments, pretax | $ | $ 1.5 | $ 0.5 |
Inventory (Details)
Inventory (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Inventory [Line Items] | ||
Raw materials | $ 9,447 | $ 8,867 |
Work in process | 39,380 | 27,717 |
Finished goods | 11,325 | 12,927 |
Total | 60,152 | 49,511 |
Current portion included in inventory | ||
Inventory [Line Items] | ||
Total | 26,711 | 27,493 |
Long-term portion included in other long-term assets | ||
Inventory [Line Items] | ||
Total | $ 33,441 | $ 22,018 |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Allocated Employee Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Oct. 01, 2021 | Sep. 30, 2022 | Oct. 01, 2021 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Total stock-based compensation expense | $ 37,337 | $ 33,966 | $ 81,718 | $ 96,654 |
Research and development | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Total stock-based compensation expense | 16,438 | 11,487 | 34,886 | 37,550 |
Selling, general and administrative | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Total stock-based compensation expense | $ 20,899 | $ 22,479 | $ 46,832 | $ 59,104 |
Stock-Based Compensation - Sc_2
Stock-Based Compensation - Schedule of Employee Service Share - Based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Oct. 01, 2021 | Sep. 30, 2022 | Oct. 01, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total stock-based compensation expense | $ 37,337 | $ 33,966 | $ 81,718 | $ 96,654 |
Stock options | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total stock-based compensation expense | 3,299 | 4,607 | 10,470 | 15,203 |
Restricted stock units | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total stock-based compensation expense | 22,233 | 13,721 | 54,234 | 40,802 |
Performance stock units | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total stock-based compensation expense | 11,331 | 14,971 | 14,621 | 37,616 |
ESPP | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total stock-based compensation expense | $ 474 | $ 667 | $ 2,393 | $ 3,033 |
Stock-Based Compensation - Narr
Stock-Based Compensation - Narrative (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||
May 25, 2022 | Mar. 31, 2022 | Sep. 30, 2022 | Oct. 01, 2021 | Sep. 30, 2022 | Oct. 01, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Increase in share reserve under 2017 plan (in shares) | 28,500,000 | |||||
Number of shares available for grant (in shares) | 31,485,656 | 31,485,656 | ||||
Reduction in share reserve after stock option or stock appreciation award (in shares) | 1 | |||||
Reduction in share reserve after all other awards (in shares) | 2 | |||||
Options granted in the period (in shares) | 588,862 | |||||
Options granted in the period (in dollars per share) | $ 19.99 | |||||
Weighted average grant-date fair value (in dollars per share) | $ 8.36 | |||||
Options outstanding (in shares) | 11,416,151 | 11,416,151 | ||||
Unrecognized compensation expense | $ 19,600 | $ 19,600 | ||||
Recognized stock-based compensation expense | 37,337 | $ 33,966 | 81,718 | $ 96,654 | ||
Restricted stock units | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Unrecognized compensation expense | $ 193,800 | $ 193,800 | ||||
Number of awards granted (in shares) | 5,292,088 | |||||
Weighted average grant date fair value, awarded (in dollars per share) | $ 20.56 | |||||
Number of awards outstanding (in shares) | 11,864,173 | 11,864,173 | ||||
Recognized stock-based compensation expense | $ 22,233 | 13,721 | $ 54,234 | 40,802 | ||
TSR-Based Restricted Stock Units | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Number of awards granted (in shares) | 1,003,482 | |||||
Maximum potential to vest | 175% | |||||
Weighted average grant date fair value, awarded (in dollars per share) | $ 33.17 | |||||
TSR-Based Restricted Stock Units | Share-based Payment Arrangement, Tranche One | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Vesting award percentage | 50% | |||||
Award vesting period | 1 year | |||||
Performance stock units | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Unrecognized compensation expense | $ 101,000 | $ 101,000 | ||||
Number of awards outstanding (in shares) | 5,367,906 | 5,367,906 | ||||
Recognized stock-based compensation expense | $ 11,331 | $ 14,971 | $ 14,621 | $ 37,616 | ||
Performance stock units | Granted 2020 | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Number of awards granted (in shares) | 495,886 | |||||
Recognized stock-based compensation expense | $ 9,700 |
Stock-Based Compensation - Esti
Stock-Based Compensation - Estimate Grant-Date Fair Value (Details) - TSR-Based Restricted Stock Units | 9 Months Ended |
Sep. 30, 2022 $ / shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Fair value of the Company's common stock on grant date (in dollars per share) | $ 20.70 |
Expected volatility | 46.85% |
Risk-free interest rate | 1.59% |
Dividend yield | 0% |
Provision For Income Taxes (Det
Provision For Income Taxes (Details) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Oct. 01, 2021 | Sep. 30, 2022 | Oct. 01, 2021 | |
Income Tax Disclosure [Abstract] | ||||
Effective income tax rate | 20.50% | 28.30% | 20.10% | 22.80% |
Net Income Per Share - Computat
Net Income Per Share - Computation of Basic and Diluted Net Income Per Share (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Oct. 01, 2021 | Sep. 30, 2022 | Oct. 01, 2021 | |
Numerator: | ||||
Net income, Basic | $ 73,210 | $ 38,204 | $ 212,455 | $ 135,897 |
Net income, Diluted | $ 73,210 | $ 38,204 | $ 212,455 | $ 135,897 |
Denominator: | ||||
Weighted-average common shares outstanding - basic (in shares) | 322,148 | 315,380 | 320,949 | 313,990 |
Dilutive securities (in shares) | 2,918 | 6,642 | 3,471 | 8,094 |
Weighted-average common shares outstanding - diluted (in shares) | 325,066 | 322,022 | 324,420 | 322,084 |
Net income per share - basic (in dollars per share) | $ 0.23 | $ 0.12 | $ 0.66 | $ 0.43 |
Net income per share - diluted (in dollars per share) | $ 0.23 | $ 0.12 | $ 0.65 | $ 0.42 |
Net Income Per Share - Potentia
Net Income Per Share - Potential Shares of Common Stock Not Included in the Computation of Diluted Net Income Per Share (Details) - shares shares in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Oct. 01, 2021 | Sep. 30, 2022 | Oct. 01, 2021 | |
Share-based Payment Arrangement | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive securities and contingently issuable shares excluded (in shares) | 15,059 | 20,346 | 15,311 | 14,213 |
Commitments and Contingencies (
Commitments and Contingencies (Details) $ in Millions | 1 Months Ended | ||||||
Apr. 15, 2022 USD ($) | Apr. 30, 2022 USD ($) ft² segment | Oct. 31, 2022 lawsuit | Sep. 30, 2022 lawsuit | Jun. 01, 2022 USD ($) | May 31, 2022 ft² | Apr. 30, 2021 lawsuit | |
Lessee, Lease, Description [Line Items] | |||||||
Operating lease right of use asset | $ 4.3 | ||||||
Operating lease liabilities | $ 4.3 | ||||||
Estimate incremental borrowing rate (in percent) | 5% | ||||||
Number of lawsuits | lawsuit | 2 | 2 | |||||
Subsequent Event | |||||||
Lessee, Lease, Description [Line Items] | |||||||
Number of lawsuits | lawsuit | 2 | ||||||
Built-To-Suit Lease And Headquarters Lease | |||||||
Lessee, Lease, Description [Line Items] | |||||||
Area of lease property (in square feet) | ft² | 220,517 | ||||||
Operating lease term | 242 months | ||||||
Number of options to extend the lease | segment | 2 | ||||||
Lease option to extend period | 5 years | ||||||
Option to terminate lease (after period) | 180 months | ||||||
Estimated monthly base rent | $ 0.7 | ||||||
Monthly base rent, lease not yet commenced, annual percentage increase | 3% | ||||||
Operating lease right of use asset | $ 160.9 | ||||||
Inclusive of operating lease liability | 44.9 | ||||||
Tenant improvement allowance | $ 116 | ||||||
Operating lease liability discounted period | 180 months | ||||||
Estimate incremental borrowing rate (in percent) | 4.90% | ||||||
1751 Expansion Space | |||||||
Lessee, Lease, Description [Line Items] | |||||||
Area of lease property (in square feet) | ft² | 34,745 |
Subsequent Events (Details)
Subsequent Events (Details) - Forecast $ in Millions | 1 Months Ended |
Nov. 30, 2022 USD ($) | |
Cybrexa Therapeutics, LLC (Cybrexa) | |
Subsequent Event [Line Items] | |
Collaborative arrangement, upfront payment | $ 60 |
Collaborative arrangement, maximum aggregate development milestone payments | 65 |
Maximum amount of warrant to be exercised | 300 |
Additional development regulatory and commercial milestones payments | 277.5 |
Sairopa, B.V. (Sairopa) | |
Subsequent Event [Line Items] | |
Collaborative arrangement, upfront payment | 40 |
Collaborative arrangement, maximum aggregate development milestone payments | 97.5 |
Additional development regulatory and commercial milestones payments | 465 |
Option to exercise, amount | $ 225 |