Cover Page
Cover Page - shares | 3 Months Ended | |
Mar. 29, 2024 | Apr. 22, 2024 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 29, 2024 | |
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, $0.001 Par Value per Share | |
Trading Symbol | EXEL | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding (in shares) | 291,292,704 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2024 | |
Document Fiscal Period Focus | Q1 | |
Entity Central Index Key | 0000939767 | |
Current Fiscal Year End Date | --01-03 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 29, 2024 | Dec. 29, 2023 |
Current assets: | ||
Cash and cash equivalents | $ 259,561 | $ 262,994 |
Short-term investments | 703,695 | 732,308 |
Trade receivables, net | 240,577 | 237,407 |
Inventory | 21,106 | 17,323 |
Prepaid expenses and other current assets | 67,490 | 67,926 |
Total current assets | 1,292,429 | 1,317,958 |
Long-term investments | 629,561 | 728,717 |
Property and equipment, net | 127,222 | 128,731 |
Deferred tax assets, net | 361,578 | 361,145 |
Goodwill | 63,684 | 63,684 |
Right-of-use assets and other | 329,278 | 342,122 |
Total assets | 2,803,752 | 2,942,357 |
Current liabilities: | ||
Accounts payable | 26,069 | 33,768 |
Accrued compensation and benefits | 72,958 | 93,325 |
Accrued clinical trial liabilities | 59,337 | 71,615 |
Rebates and fees due to customers | 75,651 | 59,619 |
Accrued collaboration liabilities | 34,704 | 27,533 |
Other current liabilities | 104,291 | 108,417 |
Total current liabilities | 373,010 | 394,277 |
Long-term portion of operating lease liabilities | 201,466 | 189,944 |
Other long-term liabilities | 101,268 | 94,224 |
Total liabilities | 675,744 | 678,445 |
Commitments and contingencies (Note 10) | ||
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: 295,032 and 302,793 at March 31, 2024, and December 31, 2023, respectively | 295 | 303 |
Additional paid-in capital | 2,391,865 | 2,440,710 |
Accumulated other comprehensive loss | (5,204) | (3,750) |
Accumulated deficit | (258,948) | (173,351) |
Total stockholders’ equity | 2,128,008 | 2,263,912 |
Total liabilities and stockholders' equity | $ 2,803,752 | $ 2,942,357 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 29, 2024 | Dec. 29, 2023 |
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) | 295,032,000 | 302,793,000 |
Shares outstanding (in shares) | 295,032,000 | 302,793,000 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Income - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 29, 2024 | Mar. 31, 2023 | |
Revenues: | ||
Total revenues | $ 425,226 | $ 408,788 |
Operating expenses: | ||
Cost of goods sold | 21,256 | 14,315 |
Research and development | 227,689 | 234,246 |
Selling, general and administrative | 113,984 | 131,397 |
Restructuring | 32,835 | 0 |
Total operating expenses | 395,764 | 379,958 |
Income from operations | 29,462 | 28,830 |
Interest income | 19,894 | 19,502 |
Other expense, net | (89) | (54) |
Income before income taxes | 49,267 | 48,278 |
Provision for income taxes | 11,950 | 8,250 |
Net income | $ 37,317 | $ 40,028 |
Net income per share: | ||
Basic (in dollars per share) | $ 0.12 | $ 0.12 |
Diluted (in dollars per share) | $ 0.12 | $ 0.12 |
Weighted-average common shares outstanding: | ||
Basic (in shares) | 300,757 | 324,420 |
Diluted (in shares) | 305,530 | 326,279 |
Net product revenues | ||
Revenues: | ||
Total revenues | $ 378,523 | $ 363,400 |
License revenues | ||
Revenues: | ||
Total revenues | 44,676 | 38,292 |
Collaboration services revenues | ||
Revenues: | ||
Total revenues | $ 2,027 | $ 7,096 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Income - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 29, 2024 | Mar. 31, 2023 | |
Statement of Comprehensive Income [Abstract] | ||
Net income | $ 37,317 | $ 40,028 |
Other comprehensive income (loss): | ||
Net unrealized gains (losses) on available-for-sale debt securities, net of tax impact of $433 and $(1,507), respectively | (1,454) | 5,232 |
Comprehensive income | $ 35,863 | $ 45,260 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Comprehensive Income (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 29, 2024 | Mar. 31, 2023 | |
Statement of Comprehensive Income [Abstract] | ||
Net unrealized gains (losses) on available-for-sale debt securities, tax impact | $ 433 | $ (1,507) |
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 Loss | Retained Earnings (Accumulated Deficit) |
Beginning balance (in shares) at Dec. 30, 2022 | 323,951 | ||||
Beginning balance at Dec. 30, 2022 | $ 2,488,427 | $ 324 | $ 2,536,849 | $ (14,521) | $ (34,225) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net income | 40,028 | 40,028 | |||
Other comprehensive income (loss) | 5,232 | 5,232 | |||
Issuance of common stock under equity incentive plans (in shares) | 1,034 | ||||
Issuance of common stock under equity incentive plans | 7,080 | $ 1 | 7,079 | ||
Stock transactions associated with taxes withheld on equity awards | (2,523) | (2,523) | |||
Stock-based compensation | 16,892 | 16,892 | |||
Ending balance (in shares) at Mar. 31, 2023 | 324,985 | ||||
Ending balance at Mar. 31, 2023 | $ 2,555,136 | $ 325 | 2,558,297 | (9,289) | 5,803 |
Beginning balance (in shares) at Dec. 29, 2023 | 302,793 | 302,793 | |||
Beginning balance at Dec. 29, 2023 | $ 2,263,912 | $ 303 | 2,440,710 | (3,750) | (173,351) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net income | 37,317 | 37,317 | |||
Other comprehensive income (loss) | (1,454) | (1,454) | |||
Issuance of common stock under equity incentive plans (in shares) | 877 | ||||
Issuance of common stock under equity incentive plans | 8,438 | $ 1 | 8,437 | ||
Stock transactions associated with taxes withheld on equity awards | (6,994) | (6,994) | |||
Repurchases of common stock (in shares) | (8,638) | ||||
Repurchases of common stock | (192,541) | $ (9) | (69,618) | (122,914) | |
Stock-based compensation | $ 19,330 | 19,330 | |||
Ending balance (in shares) at Mar. 29, 2024 | 295,032 | 295,032 | |||
Ending balance at Mar. 29, 2024 | $ 2,128,008 | $ 295 | $ 2,391,865 | $ (5,204) | $ (258,948) |
Condensed Consolidated Statem_5
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 29, 2024 | Mar. 31, 2023 | |
Statement of Cash Flows [Abstract] | ||
Net income | $ 37,317 | $ 40,028 |
Adjustments to reconcile net income to net cash provided by operating activities: | ||
Depreciation | 6,378 | 6,855 |
Stock-based compensation | 19,113 | 16,661 |
Non-cash lease expense | 6,764 | 6,731 |
Acquired in-process research and development technology | 19,500 | 36,500 |
Other, net | 9,206 | (3,743) |
Changes in operating assets and liabilities: | ||
Trade receivables, net | (3,170) | (19,178) |
Inventory | 1,715 | (8,370) |
Prepaid expenses and other assets | 10,075 | 10,372 |
Accrued collaboration liabilities | (3,829) | (1,864) |
Accounts payable and other liabilities | (34,247) | 416 |
Net cash provided by operating activities | 68,822 | 84,408 |
Cash flows from investing activities: | ||
Purchases of property, equipment and other, net | (9,691) | (12,024) |
Acquired in-process research and development technology | (8,500) | (36,500) |
Purchases of investments | (138,468) | (311,837) |
Proceeds from maturities and sales of investments | 268,452 | 310,769 |
Net cash provided by (used in) investing activities | 111,793 | (49,592) |
Cash flows from financing activities: | ||
Payments for repurchases of common stock | (185,375) | 0 |
Proceeds from issuance of common stock under equity incentive plans | 8,315 | 7,143 |
Taxes paid related to net share settlement of equity awards | (6,988) | (2,557) |
Net cash provided by (used in) financing activities | (184,048) | 4,586 |
Net increase (decrease) in cash and cash equivalents | (3,433) | 39,402 |
Cash and cash equivalents at beginning of period | 262,994 | 502,677 |
Cash and cash equivalents at end of period | $ 259,561 | $ 542,079 |
Organization and Summary of Sig
Organization and Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 29, 2024 | |
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 company innovating next-generation medicines and combination regimens at the forefront of cancer care. Through the commitment of our drug discovery, development and commercialization resources, we have produced four marketed pharmaceutical products, two of which are formulations of our flagship molecule, cabozantinib. We continue to evolve our product portfolio, leveraging our investments, expertise and strategic partnerships, to target an expanding range of tumor types and indications with our clinically differentiated pipeline of small molecules and biotherapeutics, including antibody-drug conjugates (ADCs). Sales related to cabozantinib account for the 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 other countries: as CABOMETYX® (cabozantinib) tablets for advanced renal cell carcinoma (RCC) (both alone and in combination with Bristol-Myers Squibb Company’s (BMS) nivolumab), for previously treated hepatocellular carcinoma (HCC) and for previously treated, radioactive iodine (RAI)-refractory differentiated thyroid cancer (DTC); and as COMETRIQ® (cabozantinib) capsules for progressive, metastatic medullary thyroid cancer. 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 unaudited 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. We have adopted a 52- or 53-week fiscal year policy that generally ends on the Friday closest to December 31 st . Fiscal year 2024, which is a 53-week fiscal year, will end on January 3, 2025 and fiscal year 2023, which was a 52-week fiscal year, ended on December 29, 2023. For convenience, references in this report as of and for the fiscal period ended March 29, 2024, and as of and for the fiscal years ending January 3, 2025 and ended December 29, 2023 are indicated as being as of and for the period ended March 31, 2024, and the years ending December 31, 2024 and ended December 31, 2023, respectively. The accompanying 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 three months ended March 31, 2024 are not necessarily indicative of the results that may be expected for the year ending December 31, 2024 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 thereto for the fiscal year ended December 31, 2023, included in Part II, Item 8 of our Annual Report on Form 10-K, filed with the SEC on February 6, 2023 (Fiscal 2023 Form 10-K). 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 three months ended March 31, 2024, as 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 2023 Form 10-K. Recently Adopted Accounting Pronouncements There were no new accounting pronouncements adopted by us since our filing of the Fiscal 2023 Form 10-K, which could have a significant effect on our Condensed Consolidated Financial Statements. Recent Accounting Pronouncements Not Yet Adopted In November 2023, the Financial Accounting Standards Board (FASB) issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures , which enhances the disclosures required for operating segments in our annual and interim consolidated financial statements. ASU 2023-07 is effective for us in our annual reporting for fiscal 2024 and for interim period reporting beginning in fiscal 2025 on a retrospective basis. Early adoption is permitted. We are currently evaluating the impact of ASU 2023-07 on our Consolidated Financial Statements. In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosure s, which enhances the disclosures required for income taxes in our annual consolidated financial statements. ASU 2023-09 is effective for us in our annual reporting for fiscal 2025 on a prospective basis. Early adoption and retrospective reporting are permitted. We are currently evaluating the impact of ASU 2023-09 on our Consolidated Financial Statements. |
Revenues
Revenues | 3 Months Ended |
Mar. 29, 2024 | |
Revenue from Contract with Customer [Abstract] | |
REVENUES | REVENUES Revenues consisted of the following (in thousands): Three Months Ended March 31, 2024 2023 Product revenues: Gross product revenues $ 563,785 $ 521,322 Discounts and allowances (185,262) (157,922) Net product revenues 378,523 363,400 Collaboration revenues: License revenues 44,676 38,292 Collaboration services revenues 2,027 7,096 Total collaboration revenues 46,703 45,388 Total revenues $ 425,226 $ 408,788 The percentage of total revenues by customer who individually accounted for 10% or more of our total revenues were as follows: Three Months Ended March 31, 2024 2023 Affiliates of AmerisourceBergen Corporation 19 % 17 % Affiliates of McKesson Corporation 18 % 17 % Affiliates of CVS Health Corporation 17 % 17 % Accredo Health, Incorporated 12 % 12 % Affiliates of Optum Specialty Pharmacy 10 % 10 % The percentage of trade receivables by customer who individually accounted for 10% or more of our trade receivables were as follows: March 31, 2024 December 31, 2023 Affiliates of McKesson Corporation 26 % 21 % Affiliates of AmerisourceBergen Corporation 20 % 17 % Ipsen Pharma SAS 19 % 19 % Affiliates of CVS Health Corporation 15 % 20 % Cardinal Health, Inc. 10 % 11 % Total revenues by geographic region were as follows (in thousands): Three Months Ended March 31, 2024 2023 U.S. $ 381,937 $ 367,441 Europe 35,703 33,534 Japan 7,586 7,813 Total revenues $ 425,226 $ 408,788 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 Accounting Standards Codification (ASC) Topic 606, Revenue from Contracts with Customers . 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 are recorded in accordance with ASC Topic 808, Collaborative Arrangements. 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 March 31, 2024 2023 CABOMETYX $ 376,417 $ 361,773 COMETRIQ 2,106 1,627 Net product revenues $ 378,523 $ 363,400 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, 2023 $ 25,221 $ 19,721 $ 39,898 $ 84,840 Provision related to sales made in: Current period 115,134 17,725 54,093 186,952 Prior periods (625) (1,162) 97 (1,690) Payments and customer credits issued (111,424) (17,768) (36,953) (166,145) Balance at March 31, 2024 $ 28,306 $ 18,516 $ 57,135 $ 103,957 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): March 31, 2024 December 31, 2023 Contract assets (1) $ 1,343 $ 1,321 Contract liabilities: Current portion (2) $ 4,054 $ 5,406 Long-term portion (3) 4,922 5,524 Total contract liabilities $ 8,976 $ 10,930 ____________________ (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 other long-term liabilities in the accompanying Condensed Consolidated Balance Sheets. During the three months ended March 31, 2024 and 2023, we recognized $1.6 million and $2.0 million, respectively, in revenues that were included in the beginning deferred revenues balance for those periods. During the three months ended March 31, 2024 and 2023, we recognized $45.9 million and $37.9 million, respectively, in revenues for performance obligations satisfied in previous periods. Such revenues were primarily related to royalty payments allocated to our license performance obligations for our collaborations with Ipsen, Takeda, Daiichi Sankyo and Genentech. As of March 31, 2024, $52.8 million of t he co mbined transaction prices for our Ipsen a nd Takeda collaborations were allocated to 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 2023 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 | 3 Months Ended |
Mar. 29, 2024 | |
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 biopharmaceutical companies for the commercialization and further development of our cabozantinib franchise. Additionally, we have made considerable progress under our existing research collaboration and in-licensing arrangements 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 biopharmaceutical 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 2023 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 and license agreement with Ipsen, which was subsequently amended, for the commercialization and further development of cabozantinib. Under 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 March 31, 2024 2023 License revenues $ 36,861 $ 29,812 Collaboration services revenues (1,158) 3,722 Total collaboration revenues $ 35,703 $ 33,534 As of March 31, 2024, $28.4 million of the transaction price for this collaboration agreement, as amended, was allocated to our research and development services performance obligation that has not yet been satisfied. Takeda Collaboration In January 2017, we entered into a collaboration and license agreement with Takeda, which was subsequently amended, for the commercialization and further development of cabozantinib. Under the collaboration agreement, as amended, Takeda received 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 March 31, 2024 2023 License revenues $ 2,710 $ 2,849 Collaboration services revenues 3,185 3,374 Total collaboration revenues $ 5,895 $ 6,223 As of March 31, 2024 , $24.4 million of the transaction price for this collaboration agreement, as amended, 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 (now GSK plc, or GSK), that required us to pay a 3% royalty to GSK on the worldwide net sales of any product containing 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 the U.S. market through September 2026, after which time U.S. royalties will revert back to GSK. Royalty fees earned by Royalty Pharma in connection with our sales of cabozantinib are included in cost of goods sold and as a reduction of collaboration services revenues for sales by our collaboration partners. Such royalty fees earned by Royalty Pharma were $16.7 million and $15.4 million during the three months ended March 31, 2024 and 2023, respectively. Research Collaborations, In-Licensing Arrangements and Other Business Development Activities We enter into collaborative arrangements with other pharmaceutical or biotechnology companies to develop and commercialize oncology assets or other intellectual property. Our research collaborations and in-licensing arrangements are intended to 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. Our research collaborations, in-licensing arrangements and other strategic transactions generally include upfront payments for the purchase or in-licensing of intellectual property, development, regulatory and commercial milestone payments and royalty payments, in each case contingent upon the occurrence of certain future events linked to the success of the asset in development. Certain of our research collaborations 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 the options, we are required to pay an exercise fee and then assume the responsibilities for all subsequent development, manufacturing and commercialization. As part of the 2024 Restructuring Plan (as defined below), we have terminated certain of our in-licensing collaboration arrangements including Aurigene, BioInvent International AB, Cybrexa Therapeutics LLC, NBE-Therapeutics AG and STORM Therapeutics LTD. The termination of these agreements will be effective in April 2024. During the three months ended March 31, 2024 , we recognized $22.8 million within research and development expenses on the Condensed Consolidated Statements of Income, primarily related to development milestone payments for the costs of intellectual property that have not yet achieved technological feasibility, research and development funding and other fees. As of March 31, 2024, in conjunction with the active collaborative in-licensing arrangements and asset purchase agreements, we are subject to potential future development milestone payments of up to $509.6 million, regulatory milestone payments of up to $365.4 million and commercial milestone payments of up to $2.5 billion, each in the aggregate per product or target, as well as royalties on future net sales of products. |
Cash and Investments
Cash and Investments | 3 Months Ended |
Mar. 29, 2024 | |
Investments, Debt and Equity Securities [Abstract] | |
CASH AND INVESTMENTS | CASH AND INVESTMENTS Cash, Cash Equivalents and Investments Cash, cash equivalents and investments consisted of the following (in thousands): March 31, 2024 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Debt securities available-for-sale: Commercial paper $ 203,117 $ — $ — $ 203,117 Corporate bonds 808,010 670 (4,712) 803,968 U.S. Treasury and government-sponsored enterprises 384,773 63 (2,376) 382,460 Municipal bonds 7,880 — (32) 7,848 Total debt securities available-for-sale 1,403,780 733 (7,120) 1,397,393 Cash 19 — — 19 Money market funds 133,132 — — 133,132 Certificates of deposit 62,273 — — 62,273 Total cash, cash equivalents and investments $ 1,599,204 $ 733 $ (7,120) $ 1,592,817 December 31, 2023 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Debt securities available-for-sale: Commercial paper $ 214,016 $ — $ — $ 214,016 Corporate bonds 870,870 1,652 (4,277) 868,245 U.S. Treasury and government-sponsored enterprises 409,157 414 (2,250) 407,321 Municipal bonds 7,880 10 (49) 7,841 Total debt securities available-for-sale 1,501,923 2,076 (6,576) 1,497,423 Money market funds 154,287 — — 154,287 Certificates of deposit 72,309 — — 72,309 Total cash, cash equivalents and investments $ 1,728,519 $ 2,076 $ (6,576) $ 1,724,019 Interest receivable was $11.9 million and $13.1 million as of March 31, 2024 and December 31, 2023, 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 immaterial during the three months ended March 31, 2024 and 2023. We manage credit risk associated with our investment portfolio through our investment policy, which limits purchases to high-quality issuers and 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): March 31, 2024 In an Unrealized Loss Position Less than 12 Months In an Unrealized Loss Position 12 Months or Greater Total Fair Value Gross Unrealized Losses Fair Value Gross Unrealized Losses Fair Value Gross Unrealized Losses Corporate bonds $ 358,757 $ (1,814) $ 215,894 $ (2,898) $ 574,651 $ (4,712) U.S. Treasury and government-sponsored enterprises 217,026 (951) 109,223 (1,425) 326,249 (2,376) Municipal bonds 1,879 (1) 5,969 (31) 7,848 (32) Total $ 577,662 $ (2,766) $ 331,086 $ (4,354) $ 908,748 $ (7,120) December 31, 2023 In an Unrealized Loss Position Less than 12 Months In an Unrealized Loss Position 12 Months or Greater Total Fair Value Gross Unrealized Losses Fair Value Gross Unrealized Losses Fair Value Gross Unrealized Losses Corporate bonds $ 255,958 $ (847) $ 281,837 $ (3,430) $ 537,795 $ (4,277) U.S. Treasury and government-sponsored enterprises 163,339 (406) 155,452 (1,844) 318,791 (2,250) Municipal bonds — — 5,951 (49) 5,951 (49) Total $ 419,297 $ (1,253) $ 443,240 $ (5,323) $ 862,537 $ (6,576) There were 263 and 230 debt securities available-for-sale in an unrealized loss position as of March 31, 2024 and December 31, 2023, respectively. During the three months ended March 31, 2024, 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 values of debt securities available-for-sale by contractual maturity were as follows (in thousands): March 31, 2024 December 31, 2023 Maturing in one year or less $ 767,832 $ 768,706 Maturing after one year through five years 629,561 728,717 Total debt securities available-for-sale $ 1,397,393 $ 1,497,423 |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 29, 2024 | |
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): March 31, 2024 Level 1 Level 2 Total Commercial paper $ — $ 203,117 $ 203,117 Corporate bonds — 803,968 803,968 U.S. Treasury and government-sponsored enterprises — 382,460 382,460 Municipal bonds — 7,848 7,848 Total debt securities available-for-sale — 1,397,393 1,397,393 Money market funds 133,132 — 133,132 Certificates of deposit — 62,273 62,273 Total financial assets carried at fair value $ 133,132 $ 1,459,666 $ 1,592,798 December 31, 2023 Level 1 Level 2 Total Commercial paper $ — $ 214,016 $ 214,016 Corporate bonds — 868,245 868,245 U.S. Treasury and government-sponsored enterprises — 407,321 407,321 Municipal bonds — 7,841 7,841 Total debt securities available-for-sale — 1,497,423 1,497,423 Money market funds 154,287 — 154,287 Certificates of deposit — 72,309 72,309 Total financial assets carried at fair value $ 154,287 $ 1,569,732 $ 1,724,019 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. When necessary, we record impairments of long-lived assets for the amount by which the fair value is less than the carrying value of these assets. When an impairment indicator exists, we calculate the undiscounted value of the projected cash flows for the asset, or asset group, and compare this estimated amount to the carrying amount. If the carrying amount is greater, we record an impairment loss for the excess of carrying value over fair value. In addition, in all cases of an impairment review, we reevaluate the remaining useful lives of the assets and modify them, as appropriate. In connection with the 2024 Restructuring Plan, we determined certain long-lived assets were impaired. The fair value was determined using an income approach where certain level 3 inputs were used, including estimates and assumptions on the timing and amount of discounted cash flows. See “Note 11. Restructuring” for additional information. The carrying amount of our remaining financial assets and liabilities, which include receivables and payables, approximate their fair values due to their short-term nature. Forward Foreign Currency Contracts We have entered into forward foreign currency exchange contracts that are not designated as hedges for accounting purposes to hedge certain operational exposures for the changes in foreign currency exchange rates associated with assets or liabilities denominated in foreign currencies, primarily the Euro. As of March 31, 2024 , we had one forward contract outstanding to sell €3.6 million. The forward contract with a maturity of three months is recorded at fair value and is included in other current liabilities in the accompanying Condensed Consolidated Balance Sheets. The unrealized gain on the forward contract is immaterial as of March 31, 2024. The forward contract is considered a Level 2 in the fair value hierarchy of our fair value measurements. The net realized gains (losses) we recognized on the maturity of forward contracts were immaterial for each of the three months ended March 31, 2024 and 2023 and are included in other expense, net on our Condensed Consolidated Statements of Income. |
Inventory
Inventory | 3 Months Ended |
Mar. 29, 2024 | |
Inventory Disclosure [Abstract] | |
INVENTORY | INVENTORY Inventory consisted of the following (in thousands): March 31, 2024 December 31, 2023 Raw materials $ 3,117 $ 7,313 Work in process 56,906 59,422 Finished goods 14,795 9,581 Total $ 74,818 $ 76,316 Balance Sheet classification: Current portion included in inventory $ 21,106 $ 17,323 Long-term portion included in other long-term assets 53,712 58,993 Total $ 74,818 $ 76,316 |
Stockholders_ Equity
Stockholders’ Equity | 3 Months Ended |
Mar. 29, 2024 | |
Share-Based Payment Arrangement [Abstract] | |
STOCKHOLDERS’ EQUITY | STOCKHOLDERS’ EQUITY Stock-based Compensation We have several equity incentive plans under which we granted stock options and restricted stock units (RSUs), including performance-based restricted stock units (PSUs), to employees and directors. As of March 31, 2024, 22.5 million sh ares were available for grant under the 2017 Equity Incentive Plan (as amended and restated, 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 RSUs and PSUs. We allocated the stock-based compensation expense for our equity incentive plans and our 2000 Employee Stock Purchase Plan (ESPP) as follows (in thousands): Three Months Ended March 31, 2024 2023 Research and development $ 3,892 $ 3,252 Selling, general and administrative 15,221 13,409 Total stock-based compensation expense $ 19,113 $ 16,661 Stock-based compensation expense for each type of award under our equity incentive plans and ESPP were as follows (in thousands): Three Months Ended March 31, 2024 2023 Stock options $ 1,738 $ 2,207 Restricted stock units 15,434 12,607 Performance stock units 727 794 Employee stock purchase plan 1,214 1,053 Total stock-based compensation expense $ 19,113 $ 16,661 During the three months ended March 31, 2024, we granted 0.1 million stock options with a weighted-average exercise price of $23.24 per share and a weighted-average grant date fair value of $10.08 per share. As of March 31, 2024 , there were 7.7 million stock options outstanding and $8.1 million of related unrecognized compensation expense. In February 2024, we awarded to certain employees an aggregate of 1.3 million RSUs (the target number) that are subject to a total shareholder return (TSR) market condition (the 2024 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 December 30, 2023 through January 1, 2027. Depending on the results relative to the TSR market condition, the holders of the 2024 TSR-based RSUs may earn up to 175% of the target number of shares. 50% of the shares earned pursuant to the 2024 TSR-based RSU awards will vest at the end of the performance period, and the remainder will vest approximately one year later, subject to an employee’s continuous service. These 2024 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 1, 2027. We used a Monte Carlo simulation model and the following weighted-average assumptions to determine the weighted-average grant date fair value of $20.19 per share for the 2024 TSR-based RSUs: Fair value of Exelixis common stock on grant date $ 21.71 Expected volatility 36.68 % Risk-free interest rate 4.42 % Dividend yield — % The Monte Carlo simulation model assumed correlations of returns of the stock prices of Exelixis 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 TSR based on the provisions of the awards. During the three months ended March 31, 2024, we granted 2.8 million service-based RSUs with a weighted- average grant date fair value of $21.87 per share. As of March 31, 2024 , there were 15.5 million RSUs outstanding, including RSUs that are subject to a TSR market condition, and $221.8 million of related unrecognized compensation expense. Service-based RSUs granted to employees during the three months ended March 31, 2024 have vesting conditions and contractual lives of a similar nature to those described in “Note 8. Stockholders’ Equity” of the “Notes to Consolidated Financial Statements” included in Part II, Item 8 of our Fiscal 2023 Form 10-K. As of March 31, 2024, there were 2.5 million PSUs outstanding, of which 0.9 million PSUs relate to awards that we either achieved the performance goal or determined that attainment of the performance goal was probable. Expense recognition for PSUs commences when it is determined that attainment of the performance goal is probable. As of March 31, 2024, the remaining unrecognized stock-based compensation expense for the PSUs that were either achieved or deemed probable of achievement was $3.5 million. The total unrecognized compensation expense for the PSUs for which we have not yet determined that attainment of the performance goal is probable was $37.8 million. For more information about our PSUs, see “Note 8. Stockholders’ Equity” of the “Notes to Consolidated Financial Statements” included in Part II, Item 8 of our Fiscal 2023 Form 10-K. Common Stock Repurchases In January 2024, our Board of Directors authorized a stock repurchase program to acquire up to $450 million of our outstanding common stock before the end of 2024. During the three months ended March 31, 2024, we repurchased 8.6 million shares of common stock under our stock repurchase program for an aggregate purchase price of $190.7 million. As of March 31, 2024, approximately $259.3 million remained available for future stock repurchases before the end of 2024, pursuant to our stock repurchase program. Stock repurchases under the program may be made from time to time through a variety of methods, which may include open market purchases, in block trades, 10b5-1 trading plans, accelerated share repurchase transactions, exchange transactions, or any combination of such methods. The timing and amount of any stock repurchases under the stock repurchase program will be based on a variety of factors, including ongoing assessments of the capital needs of the business, alternative investment opportunities, the market price of our common stock and general market conditions. The program does not obligate us to acquire any particular amount of our common stock, and the stock repurchase program may be modified, suspended or discontinued at any time without prior notice. |
Provision For Income Taxes
Provision For Income Taxes | 3 Months Ended |
Mar. 29, 2024 | |
Income Tax Disclosure [Abstract] | |
PROVISION FOR INCOME TAXES | PROVISION FOR INCOME TAXES The effective tax rate for the three months ended March 31, 2024, was 24.3%, as compared to 17.1% for the corresponding period in 2023. The effective tax rate for the three months ended March 31, 2024, differed from the U.S. federal statutory tax rate of 21% primarily due to state taxes and interest on uncertain tax positions, offset by the generation of federal tax credits. The effective tax rates for the three months ended March 31, 2023, 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 period and the generation of federal tax credits, partially offset by state taxes. |
Net Income Per Share
Net Income Per Share | 3 Months Ended |
Mar. 29, 2024 | |
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 March 31, 2024 2023 Numerator: Net income $ 37,317 $ 40,028 Denominator: Weighted-average common shares outstanding — basic 300,757 324,420 Dilutive securities 4,773 1,859 Weighted-average common shares outstanding — diluted 305,530 326,279 Net income per share — basic $ 0.12 $ 0.12 Net income per share — diluted $ 0.12 $ 0.12 Basic net income per share is computed using the weighted-average number of common shares outstanding during the period. The diluted net income per share is computed using the weighted-average number of shares and dilutive potential common shares outstanding during the period. Dilutive shares outstanding includes the dilutive effect of in-the-money options, unvested RSUs (including TSR-based RSUs), unvested PSUs when the performance condition is met and ESPP contributions. The dilutive effect of such equity awards is calculated based on the average share price for each fiscal period using the treasury stock method. 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 March 31, 2024 2023 Anti-dilutive securities and contingently issuable shares excluded 8,893 15,592 |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 29, 2024 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | COMMITMENTS AND CONTINGENCIES 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 sought, 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 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, 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 on January 19, 2023, the Delaware District Court issued a ruling rejecting MSN’s invalidity challenge to U.S. Patent No. 7,759,473. The Delaware District Court also ruled that MSN’s proposed ANDA product does not infringe U.S. Patent No. 8,877,776 and entered judgment that the effective date of any final FDA approval of MSN’s ANDA shall not be a date earlier than August 14, 2026, the expiration date of U.S. Patent No. 7,759,473. Final judgment was entered on January 30, 2023. This ruling in MSN I does not impact our separate and ongoing MSN II lawsuit (as defined below). 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 and amended its challenges to U.S. Patents No. 11,091,439, 11,091,440 and 11,098,015 to allege that these patents are not enforceable based on equitable grounds. 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 relief, 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, and equitable relief enjoining MSN from infringing these patents. On September 28, 2023, the Delaware District Court granted the parties’ stipulation of dismissal of MSN’s equitable defenses and counterclaims. A bench trial occurred in October 2023, and a judgment is expected during the first half of 2024. Teva ANDA Litigation In May 2021, we received notice letters regarding an ANDA Teva submitted to the FDA by Teva Pharmaceutical Industries Limited, Teva Pharmaceuticals Development, Inc. and Teva Pharmaceuticals USA, Inc. (individually and collectively referred to as Teva), 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 sought, 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. On July 18, 2023, we entered into a settlement and license agreement (the Teva Settlement Agreement) with Teva to end these litigations. Pursuant to the terms of the Teva Settlement Agreement, we will grant Teva a license to market its generic version of CABOMETYX in the U.S. beginning on January 1, 2031, if approved by the FDA and subject to conditions and exceptions common to agreements of this type. On September 15, 2023, the parties filed a joint stipulation of dismissal with the Delaware District Court, and on September 19, 2023, the Delaware District Court granted the parties’ stipulation and dismissed the case without prejudice. Cipla ANDA Litigation On February 6, 2023, we received a notice letter regarding an ANDA submitted to the FDA by Cipla, Ltd. and Cipla USA, Inc. (individually and collectively referred to as Cipla), including a Paragraph IV certification with respect to our U.S. Patents No. 8,877,776 (salt and polymorphic forms), 9,724,342 (formulations), 10,039,757 (methods of treatment), 11,091,439 (crystalline salt forms), 11,091,440 (pharmaceutical composition), 11,098,015 (methods of treatment) and 11,298,349 (pharmaceutical composition). Cipla’s notice letter did not provide a Paragraph IV certification against any additional CABOMETYX patents. On March 16, 2023, we filed a complaint in the Delaware District Court for patent infringement against Cipla asserting infringement of U.S. Patents No. 8,877,776, 11,091,439, 11,091,440, 11,098,015 and 11,298,349 arising from Cipla’s ANDA filing with the FDA. Cipla’s ANDA requests approval to market a generic version of CABOMETYX tablets prior to the expiration of the aforementioned patents. We are seeking, among other relief, an order that the effective date of any FDA approval of Cipla’s ANDA would be a date no earlier than the expiration of all of U.S. Patents No. 8,877,776, 11,091,439, 11,091,440, 11,098,015 and 11,298,349, the latest of which expires on February 10, 2032, and equitable relief enjoining Cipla from infringing these patents. On May 4, 2023, we filed, under seal, a stipulation and proposed order to stay all proceedings, and the Delaware District Court, in a sealed order on the same day, granted the proposed order and administratively closed the case. On May 5, 2023, the Delaware District Court issued a redacted version of the May 4, 2023 stipulation and proposed order. On March 27, 2024, we received notice from Cipla that it had amended its ANDA to assert additional Paragraph IV certifications. The ANDA now requests approval to market generic versions of CABOMETYX tablets with 20 mg and 40 mg dosage strengths (in addition to the 60 mg dosage strength contemplated by Cipla’s original ANDA) prior to expiration of U.S. Patents No. 8,877,776, 9,724,342, 10,039,757, 11,091,439, 11,091,440, 11,098,015 and 11,298,349. We are evaluating Cipla’s additional Paragraph IV certifications. 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. |
Restructuring
Restructuring | 3 Months Ended |
Mar. 29, 2024 | |
Restructuring and Related Activities [Abstract] | |
RESTRUCTURING | RESTRUCTURING Our Board of Directors authorized, and we implemented, a corporate restructuring plan (the 2024 Restructuring Plan) to reduce our workforce and rebalance our cost structure in alignment with our strategic priorities. Restructuring expenses expected to be incurred under the 2024 Restructuring Plan include severance and employee-related costs; asset impairment; and contract termination and other exit costs. During the three months ended March 31, 2024, we recognized $32.8 million in expenses associated with the 2024 Restructuring Plan which are presented in restructuring in the accompanying Condensed Consolidated Statements of Income. In connection with the 2024 Restructuring Plan, we exited two leases in the Greater Philadelphia area and the right-of-use assets, related leasehold improvements and certain other long-lived assets were remeasured and recorded at fair value, see “Note 5. Fair Value” for additional information. We incurred the majority of the charges related to the 2024 Restructuring Plan in the three months ended March 31, 2024, and expect the 2024 Restructuring Plan to be substantially completed by the end of the second quarter of 2024. The expected pre-tax charges are estimates and are subject to a number of assumptions and actual results may vary from the estimates provided. The restructuring activities and balances as of and for the three months ended March 31, 2024 were as follows (in thousands): Three Months Ended March 31, 2024 Accrued at December 31, 2023 Initial Costs Non-cash Charges Cash Payments Accrued at March 31, 2024 (2) Total Costs Incurred to Date Total Expected Plan Costs Severance and employee-related costs $ — $ 15,656 $ — $ (13,868) $ 1,788 $ 15,656 $ 15,656 Contract termination and other exit costs (1) — 4,861 — (18) 4,843 4,861 5,044 Asset impairment — 12,318 (12,318) — — 12,318 12,318 Total restructuring $ — $ 32,835 $ (12,318) $ (13,886) $ 6,631 $ 32,835 $ 33,018 __________________ (1) Contract termination costs consist of accruals for costs to be incurred without future economic benefit, and other exit costs expensed as incurred. (2) As of March 31, 2024, substantially all restructuring liabilities have been recorded in other current liabilities in the accompanying Condensed Consolidated Balance Sheets. |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 29, 2024 | Mar. 31, 2023 | |
Pay vs Performance Disclosure | ||
Net income | $ 37,317 | $ 40,028 |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Mar. 29, 2024 shares | |
Trading Arrangements, by Individual | |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Dana T. Aftab [Member] | |
Trading Arrangements, by Individual | |
Material Terms of Trading Arrangement | Dana T. Aftab, our Executive Vice President, Discovery and Translational Research, and Chief Scientific Officer, an officer for purposes of Section 16 of the Exchange Act, entered into a pre-arranged stock trading plan on May 25, 2023, which was subsequently modified on February 27, 2024. As modified, Dr. Aftab’s trading plan provides for the sale of up to 194,656 shares of our common stock (including shares obtained from the exercise of vested stock options covered by the trading plan) between May 30, 2024 and September 30, 2025. This trading plan is intended to satisfy the affirmative defense of Rule 10b5-1(c) under the Exchange Act and Exelixis’ policies regarding transactions in Exelixis securities. |
Name | Dana T. Aftab |
Title | Executive Vice President, Discovery and Translational Research, and Chief Scientific Officer |
Rule 10b5-1 Arrangement Adopted | true |
Adoption Date | May 25, 2023 |
Arrangement Duration | 488 days |
Aggregate Available | 194,656 |
Jeffrey J. Hessekiel [Member] | |
Trading Arrangements, by Individual | |
Material Terms of Trading Arrangement | Jeffrey J. Hessekiel, our Executive Vice President, General Counsel and Secretary, an officer for purposes of Section 16 of the Exchange Act, entered into a pre-arranged stock trading plan on February 28, 2024. Mr. Hessekiel’s trading plan provides for the sale of up to 200,000 shares of our common stock (including shares obtained from the exercise of vested stock options covered by the trading plan) between May 29, 2024 and December 31, 2024. This trading plan is intended to satisfy the affirmative defense of Rule 10b5-1(c) under the Exchange Act and Exelixis’ policies regarding transactions in Exelixis securities. |
Name | Jeffrey J. Hessekiel |
Title | Executive Vice President, General Counsel and Secretary |
Rule 10b5-1 Arrangement Adopted | true |
Adoption Date | February 28, 2024 |
Arrangement Duration | 216 days |
Aggregate Available | 200,000 |
Jack L Wyszomierski [Member] | |
Trading Arrangements, by Individual | |
Material Terms of Trading Arrangement | Jack L Wyszomierski, a member of our Board of Directors, entered into a pre-arranged stock trading plan on February 12, 2024. Mr. Wyszomierski’s trading plan provides for the sale of up to 19,973 shares of our common stock (including shares obtained from the exercise of vested stock options covered by the trading plan) between May 13, 2024 and June 12, 2024. This trading plan is intended to satisfy the affirmative defense of Rule 10b5-1(c) under the Exchange Act and Exelixis’ policies regarding transactions in Exelixis securities. |
Name | Jack L Wyszomierski |
Title | Board of Directors |
Rule 10b5-1 Arrangement Adopted | true |
Adoption Date | February 12, 2024 |
Arrangement Duration | 30 days |
Aggregate Available | 19,973 |
Organization and Summary of S_2
Organization and Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 29, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Basis of Consolidation | The accompanying unaudited 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. |
Fiscal Period | We have adopted a 52- or 53-week fiscal year policy that generally ends on the Friday closest to December 31 st . Fiscal year 2024, which is a 53-week fiscal year, will end on January 3, 2025 and fiscal year 2023, which was a 52-week fiscal year, ended on December 29, 2023. For convenience, references in this report as of and for the fiscal period ended March 29, 2024, and as of and for the fiscal years ending January 3, 2025 and ended December 29, 2023 are indicated as being as of and for the period ended March 31, 2024, and the years ending December 31, 2024 and ended December 31, 2023, respectively. |
Basis of Presentation | The accompanying 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 three months ended March 31, 2024 are not necessarily indicative of the results that may be expected for the year ending December 31, 2024 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 thereto for the fiscal year ended December 31, 2023, included in Part II, Item 8 of our Annual Report on Form 10-K, filed with the SEC on February 6, 2023 (Fiscal 2023 Form 10-K). |
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. |
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 our filing of the Fiscal 2023 Form 10-K, which could have a significant effect on our Condensed Consolidated Financial Statements. Recent Accounting Pronouncements Not Yet Adopted In November 2023, the Financial Accounting Standards Board (FASB) issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures , which enhances the disclosures required for operating segments in our annual and interim consolidated financial statements. ASU 2023-07 is effective for us in our annual reporting for fiscal 2024 and for interim period reporting beginning in fiscal 2025 on a retrospective basis. Early adoption is permitted. We are currently evaluating the impact of ASU 2023-07 on our Consolidated Financial Statements. In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosure s, which enhances the disclosures required for income taxes in our annual consolidated financial statements. ASU 2023-09 is effective for us in our annual reporting for fiscal 2025 on a prospective basis. Early adoption and retrospective reporting are permitted. We are currently evaluating the impact of ASU 2023-09 on our 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 Accounting Standards Codification (ASC) Topic 606, Revenue from Contracts with Customers . 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 are recorded in accordance with ASC Topic 808, Collaborative Arrangements. 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) | 3 Months Ended |
Mar. 29, 2024 | |
Revenue from Contract with Customer [Abstract] | |
Schedule of Disaggregation of Revenue | Revenues consisted of the following (in thousands): Three Months Ended March 31, 2024 2023 Product revenues: Gross product revenues $ 563,785 $ 521,322 Discounts and allowances (185,262) (157,922) Net product revenues 378,523 363,400 Collaboration revenues: License revenues 44,676 38,292 Collaboration services revenues 2,027 7,096 Total collaboration revenues 46,703 45,388 Total revenues $ 425,226 $ 408,788 Net product revenues by product were as follows (in thousands): Three Months Ended March 31, 2024 2023 CABOMETYX $ 376,417 $ 361,773 COMETRIQ 2,106 1,627 Net product revenues $ 378,523 $ 363,400 |
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 March 31, 2024 2023 Affiliates of AmerisourceBergen Corporation 19 % 17 % Affiliates of McKesson Corporation 18 % 17 % Affiliates of CVS Health Corporation 17 % 17 % Accredo Health, Incorporated 12 % 12 % Affiliates of Optum Specialty Pharmacy 10 % 10 % The percentage of trade receivables by customer who individually accounted for 10% or more of our trade receivables were as follows: March 31, 2024 December 31, 2023 Affiliates of McKesson Corporation 26 % 21 % Affiliates of AmerisourceBergen Corporation 20 % 17 % Ipsen Pharma SAS 19 % 19 % Affiliates of CVS Health Corporation 15 % 20 % Cardinal Health, Inc. 10 % 11 % |
Schedule of Revenues Disaggregated by Geographic Region | Total revenues by geographic region were as follows (in thousands): Three Months Ended March 31, 2024 2023 U.S. $ 381,937 $ 367,441 Europe 35,703 33,534 Japan 7,586 7,813 Total revenues $ 425,226 $ 408,788 |
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, 2023 $ 25,221 $ 19,721 $ 39,898 $ 84,840 Provision related to sales made in: Current period 115,134 17,725 54,093 186,952 Prior periods (625) (1,162) 97 (1,690) Payments and customer credits issued (111,424) (17,768) (36,953) (166,145) Balance at March 31, 2024 $ 28,306 $ 18,516 $ 57,135 $ 103,957 |
Schedule of Other Assets and Other Liabilities | Contract assets and liabilities were as follows (in thousands): March 31, 2024 December 31, 2023 Contract assets (1) $ 1,343 $ 1,321 Contract liabilities: Current portion (2) $ 4,054 $ 5,406 Long-term portion (3) 4,922 5,524 Total contract liabilities $ 8,976 $ 10,930 ____________________ (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 other long-term liabilities in the accompanying Condensed Consolidated Balance Sheets. |
Collaboration Agreements And _2
Collaboration Agreements And Business Development Activities (Tables) | 3 Months Ended |
Mar. 29, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedule of Collaborative Revenues Under Collaboration and License Agreement | Revenues under the collaboration agreement with Ipsen were as follows (in thousands): Three Months Ended March 31, 2024 2023 License revenues $ 36,861 $ 29,812 Collaboration services revenues (1,158) 3,722 Total collaboration revenues $ 35,703 $ 33,534 Revenues under the collaboration agreement with Takeda were as follows (in thousands): Three Months Ended March 31, 2024 2023 License revenues $ 2,710 $ 2,849 Collaboration services revenues 3,185 3,374 Total collaboration revenues $ 5,895 $ 6,223 |
Cash and Investments (Tables)
Cash and Investments (Tables) | 3 Months Ended |
Mar. 29, 2024 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of Investments by Security Type | Cash, cash equivalents and investments consisted of the following (in thousands): March 31, 2024 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Debt securities available-for-sale: Commercial paper $ 203,117 $ — $ — $ 203,117 Corporate bonds 808,010 670 (4,712) 803,968 U.S. Treasury and government-sponsored enterprises 384,773 63 (2,376) 382,460 Municipal bonds 7,880 — (32) 7,848 Total debt securities available-for-sale 1,403,780 733 (7,120) 1,397,393 Cash 19 — — 19 Money market funds 133,132 — — 133,132 Certificates of deposit 62,273 — — 62,273 Total cash, cash equivalents and investments $ 1,599,204 $ 733 $ (7,120) $ 1,592,817 December 31, 2023 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Debt securities available-for-sale: Commercial paper $ 214,016 $ — $ — $ 214,016 Corporate bonds 870,870 1,652 (4,277) 868,245 U.S. Treasury and government-sponsored enterprises 409,157 414 (2,250) 407,321 Municipal bonds 7,880 10 (49) 7,841 Total debt securities available-for-sale 1,501,923 2,076 (6,576) 1,497,423 Money market funds 154,287 — — 154,287 Certificates of deposit 72,309 — — 72,309 Total cash, cash equivalents and investments $ 1,728,519 $ 2,076 $ (6,576) $ 1,724,019 |
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): March 31, 2024 In an Unrealized Loss Position Less than 12 Months In an Unrealized Loss Position 12 Months or Greater Total Fair Value Gross Unrealized Losses Fair Value Gross Unrealized Losses Fair Value Gross Unrealized Losses Corporate bonds $ 358,757 $ (1,814) $ 215,894 $ (2,898) $ 574,651 $ (4,712) U.S. Treasury and government-sponsored enterprises 217,026 (951) 109,223 (1,425) 326,249 (2,376) Municipal bonds 1,879 (1) 5,969 (31) 7,848 (32) Total $ 577,662 $ (2,766) $ 331,086 $ (4,354) $ 908,748 $ (7,120) December 31, 2023 In an Unrealized Loss Position Less than 12 Months In an Unrealized Loss Position 12 Months or Greater Total Fair Value Gross Unrealized Losses Fair Value Gross Unrealized Losses Fair Value Gross Unrealized Losses Corporate bonds $ 255,958 $ (847) $ 281,837 $ (3,430) $ 537,795 $ (4,277) U.S. Treasury and government-sponsored enterprises 163,339 (406) 155,452 (1,844) 318,791 (2,250) Municipal bonds — — 5,951 (49) 5,951 (49) Total $ 419,297 $ (1,253) $ 443,240 $ (5,323) $ 862,537 $ (6,576) |
Schedule of Fair Value of Cash Equivalents and Investments by Contractual Maturity | The fair values of debt securities available-for-sale by contractual maturity were as follows (in thousands): March 31, 2024 December 31, 2023 Maturing in one year or less $ 767,832 $ 768,706 Maturing after one year through five years 629,561 728,717 Total debt securities available-for-sale $ 1,397,393 $ 1,497,423 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 29, 2024 | |
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): March 31, 2024 Level 1 Level 2 Total Commercial paper $ — $ 203,117 $ 203,117 Corporate bonds — 803,968 803,968 U.S. Treasury and government-sponsored enterprises — 382,460 382,460 Municipal bonds — 7,848 7,848 Total debt securities available-for-sale — 1,397,393 1,397,393 Money market funds 133,132 — 133,132 Certificates of deposit — 62,273 62,273 Total financial assets carried at fair value $ 133,132 $ 1,459,666 $ 1,592,798 December 31, 2023 Level 1 Level 2 Total Commercial paper $ — $ 214,016 $ 214,016 Corporate bonds — 868,245 868,245 U.S. Treasury and government-sponsored enterprises — 407,321 407,321 Municipal bonds — 7,841 7,841 Total debt securities available-for-sale — 1,497,423 1,497,423 Money market funds 154,287 — 154,287 Certificates of deposit — 72,309 72,309 Total financial assets carried at fair value $ 154,287 $ 1,569,732 $ 1,724,019 |
Inventory (Tables)
Inventory (Tables) | 3 Months Ended |
Mar. 29, 2024 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory | Inventory consisted of the following (in thousands): March 31, 2024 December 31, 2023 Raw materials $ 3,117 $ 7,313 Work in process 56,906 59,422 Finished goods 14,795 9,581 Total $ 74,818 $ 76,316 Balance Sheet classification: Current portion included in inventory $ 21,106 $ 17,323 Long-term portion included in other long-term assets 53,712 58,993 Total $ 74,818 $ 76,316 |
Stockholders_ Equity (Tables)
Stockholders’ Equity (Tables) | 3 Months Ended |
Mar. 29, 2024 | |
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 2000 Employee Stock Purchase Plan (ESPP) as follows (in thousands): Three Months Ended March 31, 2024 2023 Research and development $ 3,892 $ 3,252 Selling, general and administrative 15,221 13,409 Total stock-based compensation expense $ 19,113 $ 16,661 Stock-based compensation expense for each type of award under our equity incentive plans and ESPP were as follows (in thousands): Three Months Ended March 31, 2024 2023 Stock options $ 1,738 $ 2,207 Restricted stock units 15,434 12,607 Performance stock units 727 794 Employee stock purchase plan 1,214 1,053 Total stock-based compensation expense $ 19,113 $ 16,661 |
Schedule Of Share-Based Payment Award, Equity Instruments Other Than Options, Valuation Assumptions | We used a Monte Carlo simulation model and the following weighted-average assumptions to determine the weighted-average grant date fair value of $20.19 per share for the 2024 TSR-based RSUs: Fair value of Exelixis common stock on grant date $ 21.71 Expected volatility 36.68 % Risk-free interest rate 4.42 % Dividend yield — % |
Net Income Per Share (Tables)
Net Income Per Share (Tables) | 3 Months Ended |
Mar. 29, 2024 | |
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 March 31, 2024 2023 Numerator: Net income $ 37,317 $ 40,028 Denominator: Weighted-average common shares outstanding — basic 300,757 324,420 Dilutive securities 4,773 1,859 Weighted-average common shares outstanding — diluted 305,530 326,279 Net income per share — basic $ 0.12 $ 0.12 Net income per share — diluted $ 0.12 $ 0.12 |
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 March 31, 2024 2023 Anti-dilutive securities and contingently issuable shares excluded 8,893 15,592 |
Restructuring (Tables)
Restructuring (Tables) | 3 Months Ended |
Mar. 29, 2024 | |
Restructuring and Related Activities [Abstract] | |
Schedule of Restructuring Activities | The restructuring activities and balances as of and for the three months ended March 31, 2024 were as follows (in thousands): Three Months Ended March 31, 2024 Accrued at December 31, 2023 Initial Costs Non-cash Charges Cash Payments Accrued at March 31, 2024 (2) Total Costs Incurred to Date Total Expected Plan Costs Severance and employee-related costs $ — $ 15,656 $ — $ (13,868) $ 1,788 $ 15,656 $ 15,656 Contract termination and other exit costs (1) — 4,861 — (18) 4,843 4,861 5,044 Asset impairment — 12,318 (12,318) — — 12,318 12,318 Total restructuring $ — $ 32,835 $ (12,318) $ (13,886) $ 6,631 $ 32,835 $ 33,018 __________________ (1) Contract termination costs consist of accruals for costs to be incurred without future economic benefit, and other exit costs expensed as incurred. (2) As of March 31, 2024, substantially all restructuring liabilities have been recorded in other current liabilities in the accompanying Condensed Consolidated Balance Sheets. |
Organization and Summary of S_3
Organization and Summary of Significant Accounting Policies (Details) | 3 Months Ended |
Mar. 29, 2024 product segment | |
Organization And Summary Of Significant Policies [Line Items] | |
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 | |
Mar. 29, 2024 | Mar. 31, 2023 | |
Disaggregation of Revenue [Line Items] | ||
Total revenues | $ 425,226 | $ 408,788 |
Gross product revenues | ||
Disaggregation of Revenue [Line Items] | ||
Total revenues | 563,785 | 521,322 |
Discounts and allowances | ||
Disaggregation of Revenue [Line Items] | ||
Total revenues | (185,262) | (157,922) |
Net product revenues | ||
Disaggregation of Revenue [Line Items] | ||
Total revenues | 378,523 | 363,400 |
License revenues | ||
Disaggregation of Revenue [Line Items] | ||
Total revenues | 44,676 | 38,292 |
Collaboration services revenues | ||
Disaggregation of Revenue [Line Items] | ||
Total revenues | 2,027 | 7,096 |
Total collaboration revenues | ||
Disaggregation of Revenue [Line Items] | ||
Total revenues | $ 46,703 | $ 45,388 |
Revenues - Revenues Disaggregat
Revenues - Revenues Disaggregated by Concentration Risks (Details) - Customer Concentration Risk | 3 Months Ended | 12 Months Ended | |
Mar. 29, 2024 | Mar. 31, 2023 | Dec. 29, 2023 | |
Affiliates of AmerisourceBergen Corporation | Revenue | |||
Concentration Risk [Line Items] | |||
Percent of total revenues | 19% | 17% | |
Affiliates of AmerisourceBergen Corporation | Accounts Receivable | |||
Concentration Risk [Line Items] | |||
Percent of total revenues | 20% | 17% | |
Affiliates of McKesson Corporation | Revenue | |||
Concentration Risk [Line Items] | |||
Percent of total revenues | 18% | 17% | |
Affiliates of McKesson Corporation | Accounts Receivable | |||
Concentration Risk [Line Items] | |||
Percent of total revenues | 26% | 21% | |
Affiliates of CVS Health Corporation | Revenue | |||
Concentration Risk [Line Items] | |||
Percent of total revenues | 17% | 17% | |
Affiliates of CVS Health Corporation | Accounts Receivable | |||
Concentration Risk [Line Items] | |||
Percent of total revenues | 15% | 20% | |
Accredo Health, Incorporated | Revenue | |||
Concentration Risk [Line Items] | |||
Percent of total revenues | 12% | 12% | |
Affiliates of Optum Specialty Pharmacy | Revenue | |||
Concentration Risk [Line Items] | |||
Percent of total revenues | 10% | 10% | |
Ipsen Pharma SAS | Accounts Receivable | |||
Concentration Risk [Line Items] | |||
Percent of total revenues | 19% | 19% | |
Cardinal Health, Inc. | Accounts Receivable | |||
Concentration Risk [Line Items] | |||
Percent of total revenues | 10% | 11% |
Revenues - Revenues Disaggreg_2
Revenues - Revenues Disaggregated by Geographic Region (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 29, 2024 | Mar. 31, 2023 | |
Disaggregation of Revenue [Line Items] | ||
Total revenues | $ 425,226 | $ 408,788 |
U.S. | ||
Disaggregation of Revenue [Line Items] | ||
Total revenues | 381,937 | 367,441 |
Europe | ||
Disaggregation of Revenue [Line Items] | ||
Total revenues | 35,703 | 33,534 |
Japan | ||
Disaggregation of Revenue [Line Items] | ||
Total revenues | $ 7,586 | $ 7,813 |
Revenues - Net Product Revenues
Revenues - Net Product Revenues Disaggregated by Product (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 29, 2024 | Mar. 31, 2023 | |
Disaggregation of Revenue [Line Items] | ||
Total revenues | $ 425,226 | $ 408,788 |
Net product revenues | ||
Disaggregation of Revenue [Line Items] | ||
Total revenues | 378,523 | 363,400 |
CABOMETYX | ||
Disaggregation of Revenue [Line Items] | ||
Total revenues | 376,417 | 361,773 |
COMETRIQ | ||
Disaggregation of Revenue [Line Items] | ||
Total revenues | $ 2,106 | $ 1,627 |
Revenues - Activities and Endin
Revenues - Activities and Ending Reserve Balances for Significant Categories of Discounts and Allowances (Details) $ in Thousands | 3 Months Ended |
Mar. 29, 2024 USD ($) | |
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | |
Balance at December 31, 2023 | $ 84,840 |
Provision related to sales made in: | |
Current period | 186,952 |
Prior periods | (1,690) |
Payments and customer credits issued | (166,145) |
Balance at March 31, 2024 | 103,957 |
Chargebacks, Discounts for Prompt Payment and Other | |
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | |
Balance at December 31, 2023 | 25,221 |
Provision related to sales made in: | |
Current period | 115,134 |
Prior periods | (625) |
Payments and customer credits issued | (111,424) |
Balance at March 31, 2024 | 28,306 |
Other Customer Credits/Fees and Co-pay Assistance | |
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | |
Balance at December 31, 2023 | 19,721 |
Provision related to sales made in: | |
Current period | 17,725 |
Prior periods | (1,162) |
Payments and customer credits issued | (17,768) |
Balance at March 31, 2024 | 18,516 |
Rebates | |
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | |
Balance at December 31, 2023 | 39,898 |
Provision related to sales made in: | |
Current period | 54,093 |
Prior periods | 97 |
Payments and customer credits issued | (36,953) |
Balance at March 31, 2024 | $ 57,135 |
Revenues - Contract Assets and
Revenues - Contract Assets and Liabilities (Details) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 29, 2024 | Mar. 31, 2023 | Dec. 29, 2023 | |
Revenue from Contract with Customer [Abstract] | |||
Contract assets | $ 1,343 | $ 1,321 | |
Contract liabilities: | |||
Current portion | 4,054 | 5,406 | |
Long-term portion | 4,922 | 5,524 | |
Total contract liabilities | 8,976 | $ 10,930 | |
Disaggregation of Revenue [Line Items] | |||
Contract revenue recognized, including revenue from deferred revenue beginning balance | 1,600 | $ 2,000 | |
Ipsen, Takeda, Daiichi Sankyo and Genentech Collaborations | |||
Disaggregation of Revenue [Line Items] | |||
Revenues recognized for performance obligations satisfied in previous periods | 45,900 | $ 37,900 | |
Ipsen And Takeda Collaborations | |||
Disaggregation of Revenue [Line Items] | |||
Remaining performance obligation | $ 52,800 |
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 | |
Mar. 29, 2024 | Mar. 31, 2023 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Total revenues | $ 425,226 | $ 408,788 |
Collaborative Arrangement with Ipsen | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Total revenues | 35,703 | 33,534 |
License revenues | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Total revenues | 44,676 | 38,292 |
License revenues | Collaborative Arrangement with Ipsen | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Total revenues | 36,861 | 29,812 |
Collaboration services revenues | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Total revenues | 2,027 | 7,096 |
Collaboration services revenues | Collaborative Arrangement with Ipsen | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Total revenues | $ (1,158) | $ 3,722 |
Collaboration Agreements And _4
Collaboration Agreements And Business Development Activities - Ipsen Collaboration Narrative (Details) $ in Millions | Mar. 29, 2024 USD ($) |
Collaborative Arrangement with Ipsen | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |
Remaining performance obligation | $ 28.4 |
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 | |
Mar. 29, 2024 | Mar. 31, 2023 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Total revenues | $ 425,226 | $ 408,788 |
Collaborative Arrangement with Takeda | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Total revenues | 5,895 | 6,223 |
License revenues | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Total revenues | 44,676 | 38,292 |
License revenues | Collaborative Arrangement with Takeda | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Total revenues | 2,710 | 2,849 |
Collaboration services revenues | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Total revenues | 2,027 | 7,096 |
Collaboration services revenues | Collaborative Arrangement with Takeda | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Total revenues | $ 3,185 | $ 3,374 |
Collaboration Agreements And _6
Collaboration Agreements And Business Development Activities - Takeda Collaboration Narrative (Details) $ in Millions | Mar. 29, 2024 USD ($) |
Collaborative Arrangement with Takeda | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |
Remaining performance obligation | $ 24.4 |
Collaboration Agreements And _7
Collaboration Agreements And Business Development Activities -Royalty Pharma Narrative (Details) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 29, 2024 | Mar. 31, 2023 | |
Collaborative Arrangements with Glaxo Smith Kline | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Percent of royalty on net sale | 3% | |
Collaborative Arrangements with Royalty Pharma | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Royalty expense | $ 16.7 | $ 15.4 |
Collaboration Agreements And _8
Collaboration Agreements And Business Development Activities - Research Collaborations and In-Licensing Arrangements Narrative (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 29, 2024 | Mar. 31, 2023 | |
Asset Acquisition [Line Items] | ||
Research and development | $ 227,689 | $ 234,246 |
Research Collaborations, In-Licensing Arrangements and Other Business Development Activities | ||
Asset Acquisition [Line Items] | ||
Research and development | 22,800 | |
Collaborative arrangement, maximum aggregate development milestone payments | 509,600 | |
Collaborative arrangement, maximum aggregate regulatory milestone payments | 365,400 | |
Collaborative arrangement, rights and obligations, maximum aggregate commercial milestone payments | $ 2,500,000 |
Cash and Investments - Investme
Cash and Investments - Investments by Security Type (Details) - USD ($) $ in Thousands | Mar. 29, 2024 | Dec. 29, 2023 |
Debt securities available-for-sale: | ||
Amortized Cost | $ 1,403,780 | $ 1,501,923 |
Gross Unrealized Gains | 733 | 2,076 |
Gross Unrealized Losses | (7,120) | (6,576) |
Fair Value | 1,397,393 | 1,497,423 |
Cash, Cash Equivalents, Restricted Cash and Restricted Cash Equivalents | ||
Amortized Cost | 1,599,204 | 1,728,519 |
Gross Unrealized Gains | 733 | 2,076 |
Gross Unrealized Losses | (7,120) | (6,576) |
Fair Value | 1,592,817 | 1,724,019 |
Commercial paper | ||
Debt securities available-for-sale: | ||
Amortized Cost | 203,117 | 214,016 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | 203,117 | 214,016 |
Corporate bonds | ||
Debt securities available-for-sale: | ||
Amortized Cost | 808,010 | 870,870 |
Gross Unrealized Gains | 670 | 1,652 |
Gross Unrealized Losses | (4,712) | (4,277) |
Fair Value | 803,968 | 868,245 |
U.S. Treasury and government-sponsored enterprises | ||
Debt securities available-for-sale: | ||
Amortized Cost | 384,773 | 409,157 |
Gross Unrealized Gains | 63 | 414 |
Gross Unrealized Losses | (2,376) | (2,250) |
Fair Value | 382,460 | 407,321 |
Municipal bonds | ||
Debt securities available-for-sale: | ||
Amortized Cost | 7,880 | 7,880 |
Gross Unrealized Gains | 0 | 10 |
Gross Unrealized Losses | (32) | (49) |
Fair Value | 7,848 | 7,841 |
Cash | ||
Cash, Cash Equivalents, Restricted Cash and Restricted Cash Equivalents | ||
Amortized Cost | 19 | |
Gross Unrealized Gains | 0 | |
Gross Unrealized Losses | 0 | |
Fair Value | 19 | |
Money market funds | ||
Cash, Cash Equivalents, Restricted Cash and Restricted Cash Equivalents | ||
Amortized Cost | 133,132 | 154,287 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | 133,132 | 154,287 |
Certificates of deposit | ||
Cash, Cash Equivalents, Restricted Cash and Restricted Cash Equivalents | ||
Amortized Cost | 62,273 | 72,309 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | $ 62,273 | $ 72,309 |
Cash and Investments - Narrativ
Cash and Investments - Narrative (Details) | Mar. 29, 2024 USD ($) investment | Dec. 29, 2023 USD ($) investment |
Investments, Debt and Equity Securities [Abstract] | ||
Interest receivable | $ 11,900,000 | $ 13,100,000 |
Number of investments in an unrealized loss position | investment | 263 | 230 |
Allowance for credit losses | $ 0 |
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 | Mar. 29, 2024 | Dec. 29, 2023 |
Fair Value | ||
In an Unrealized Loss Position Less than 12 Months | $ 577,662 | $ 419,297 |
In an Unrealized Loss Position 12 Months or Greater | 331,086 | 443,240 |
Total | 908,748 | 862,537 |
Gross Unrealized Losses | ||
In an Unrealized Loss Position Less than 12 Months | (2,766) | (1,253) |
In an Unrealized Loss Position 12 Months or Greater | (4,354) | (5,323) |
Total | (7,120) | (6,576) |
Corporate bonds | ||
Fair Value | ||
In an Unrealized Loss Position Less than 12 Months | 358,757 | 255,958 |
In an Unrealized Loss Position 12 Months or Greater | 215,894 | 281,837 |
Total | 574,651 | 537,795 |
Gross Unrealized Losses | ||
In an Unrealized Loss Position Less than 12 Months | (1,814) | (847) |
In an Unrealized Loss Position 12 Months or Greater | (2,898) | (3,430) |
Total | (4,712) | (4,277) |
U.S. Treasury and government-sponsored enterprises | ||
Fair Value | ||
In an Unrealized Loss Position Less than 12 Months | 217,026 | 163,339 |
In an Unrealized Loss Position 12 Months or Greater | 109,223 | 155,452 |
Total | 326,249 | 318,791 |
Gross Unrealized Losses | ||
In an Unrealized Loss Position Less than 12 Months | (951) | (406) |
In an Unrealized Loss Position 12 Months or Greater | (1,425) | (1,844) |
Total | (2,376) | (2,250) |
Municipal bonds | ||
Fair Value | ||
In an Unrealized Loss Position Less than 12 Months | 1,879 | 0 |
In an Unrealized Loss Position 12 Months or Greater | 5,969 | 5,951 |
Total | 7,848 | 5,951 |
Gross Unrealized Losses | ||
In an Unrealized Loss Position Less than 12 Months | (1) | 0 |
In an Unrealized Loss Position 12 Months or Greater | (31) | (49) |
Total | $ (32) | $ (49) |
Cash and Investments - Fair V_2
Cash and Investments - Fair Value of Cash Equivalents and Investments by Contractual Maturity (Details) - USD ($) $ in Thousands | Mar. 29, 2024 | Dec. 29, 2023 |
Investments, Debt and Equity Securities [Abstract] | ||
Maturing in one year or less | $ 767,832 | $ 768,706 |
Maturing after one year through five years | 629,561 | 728,717 |
Total debt securities available-for-sale | $ 1,397,393 | $ 1,497,423 |
Fair Value Measurements - Fair
Fair Value Measurements - Fair Value Hierarchy (Details) - USD ($) $ in Thousands | Mar. 29, 2024 | Dec. 29, 2023 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total debt securities available-for-sale | $ 1,397,393 | $ 1,497,423 |
Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total debt securities available-for-sale | 1,397,393 | 1,497,423 |
Total financial assets carried at fair value | 1,592,798 | 1,724,019 |
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 | 133,132 | 154,287 |
Level 2 | Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total debt securities available-for-sale | 1,397,393 | 1,497,423 |
Total financial assets carried at fair value | 1,459,666 | 1,569,732 |
Commercial paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total debt securities available-for-sale | 203,117 | 214,016 |
Commercial paper | Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total debt securities available-for-sale | 203,117 | 214,016 |
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 | 203,117 | 214,016 |
Corporate bonds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total debt securities available-for-sale | 803,968 | 868,245 |
Corporate bonds | Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total debt securities available-for-sale | 803,968 | 868,245 |
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 | 803,968 | 868,245 |
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 | 382,460 | 407,321 |
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 | 382,460 | 407,321 |
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 | 382,460 | 407,321 |
Municipal bonds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total debt securities available-for-sale | 7,848 | 7,841 |
Municipal bonds | Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total debt securities available-for-sale | 7,848 | 7,841 |
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 | 7,848 | 7,841 |
Money market funds | Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 133,132 | 154,287 |
Money market funds | Level 1 | Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 133,132 | 154,287 |
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 | 62,273 | 72,309 |
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 | $ 62,273 | $ 72,309 |
Fair Value Measurements - Narra
Fair Value Measurements - Narratives (Details) - Foreign Exchange Forward € in Millions | 3 Months Ended |
Mar. 29, 2024 EUR (€) derivative_instrument | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Number of contract | derivative_instrument | 1 |
Derivative notional amount | € | € 3.6 |
Derivative term of contract | 3 months |
Inventory (Details)
Inventory (Details) - USD ($) $ in Thousands | Mar. 29, 2024 | Dec. 29, 2023 |
Inventory [Line Items] | ||
Raw materials | $ 3,117 | $ 7,313 |
Work in process | 56,906 | 59,422 |
Finished goods | 14,795 | 9,581 |
Total | 74,818 | 76,316 |
Current portion included in inventory | ||
Inventory [Line Items] | ||
Total | 21,106 | 17,323 |
Long-term portion included in other long-term assets | ||
Inventory [Line Items] | ||
Total | $ 53,712 | $ 58,993 |
Stockholders' Equity - Narrativ
Stockholders' Equity - Narrative (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | |
Feb. 29, 2024 | Mar. 29, 2024 | Jan. 31, 2024 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
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) | 100,000 | ||
Options granted in the period (in dollars per share) | $ 23.24 | ||
Options, weighted-average grant date fair value (in dollars per share) | $ 10.08 | ||
Options outstanding (in shares) | 7,700,000 | ||
Options, unrecognized compensation expense | $ 8,100 | ||
Repurchases of common stock | $ 192,541 | ||
January 2024 Repurchase Program | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock repurchase program, authorized amount | $ 450,000 | ||
Repurchases of common stock (in shares) | 8,600,000 | ||
Repurchases of common stock | $ 190,700 | ||
Stock repurchase program, remaining authorized repurchase amount | $ 259,300 | ||
TSR-Based Restricted Stock Units | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of awards granted (in shares) | 1,300,000 | ||
Maximum potential to vest | 175% | ||
Weighted average grant date fair value, awarded (in dollars per share) | $ 20.19 | ||
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% | ||
TSR-Based Restricted Stock Units | Share-based Payment Arrangement, Tranche Two | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Award vesting period | 1 year | ||
Restricted stock units | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of awards granted (in shares) | 2,800,000 | ||
Weighted average grant date fair value, awarded (in dollars per share) | $ 21.87 | ||
Number of awards outstanding (in shares) | 15,500,000 | ||
Share-based payment arrangement, nonvested award, excluding option, cost not yet recognized, amount | $ 221,800 | ||
Performance stock units | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of awards outstanding (in shares) | 2,500,000 | ||
Share-based payment arrangement, nonvested award, excluding option, cost not yet recognized, amount | $ 3,500 | ||
Performance Shares, Target Achieved Or Probable | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of awards outstanding (in shares) | 900,000 | ||
Share-based payment arrangement, nonvested award, excluding option, cost not yet recognized, amount | $ 37,800 | ||
Amended And Restated 2017 Equity Incentive Plan | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of shares available for grant (in shares) | 22,500,000 |
Stockholders_ Equity - Schedule
Stockholders’ Equity - Schedule of Allocated Employee Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 29, 2024 | Mar. 31, 2023 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Total stock-based compensation expense | $ 19,113 | $ 16,661 |
Research and development | ||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Total stock-based compensation expense | 3,892 | 3,252 |
Selling, general and administrative | ||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Total stock-based compensation expense | $ 15,221 | $ 13,409 |
Stockholders_ Equity - Schedu_2
Stockholders’ Equity - Schedule of Employee Service Share - Based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 29, 2024 | Mar. 31, 2023 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock-based compensation expense | $ 19,113 | $ 16,661 |
Stock options | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock-based compensation expense | 1,738 | 2,207 |
Restricted stock units | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock-based compensation expense | 15,434 | 12,607 |
Performance stock units | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock-based compensation expense | 727 | 794 |
Employee stock purchase plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock-based compensation expense | $ 1,214 | $ 1,053 |
Stockholders_ Equity - Estimate
Stockholders’ Equity - Estimate Grant-Date Fair Value (Details) - TSR-Based Restricted Stock Units | 3 Months Ended |
Mar. 29, 2024 $ / shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Weighted average grant date fair value, awarded (in dollars per share) | $ 20.19 |
Fair value of Exelixis common stock on grant date (in dollars per share) | $ 21.71 |
Expected volatility | 36.68% |
Risk-free interest rate | 4.42% |
Dividend yield | 0% |
Provision For Income Taxes (Det
Provision For Income Taxes (Details) | 3 Months Ended | |
Mar. 29, 2024 | Mar. 31, 2023 | |
Income Tax Disclosure [Abstract] | ||
Effective income tax rate | 24.30% | 17.10% |
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 | |
Mar. 29, 2024 | Mar. 31, 2023 | |
Numerator: | ||
Net income | $ 37,317 | $ 40,028 |
Denominator: | ||
Weighted-average common shares outstanding - basic (in shares) | 300,757 | 324,420 |
Dilutive securities (in shares) | 4,773 | 1,859 |
Weighted-average common shares outstanding - diluted (in shares) | 305,530 | 326,279 |
Net income per share - basic (in dollars per share) | $ 0.12 | $ 0.12 |
Net income per share - diluted (in dollars per share) | $ 0.12 | $ 0.12 |
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 | |
Mar. 29, 2024 | Mar. 31, 2023 | |
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) | 8,893 | 15,592 |
Commitments and Contingencies (
Commitments and Contingencies (Details) | Jan. 11, 2022 patent | Oct. 31, 2022 lawsuit | Sep. 30, 2022 lawsuit | Apr. 30, 2021 lawsuit |
Other Commitments [Line Items] | ||||
Number of lawsuits | 2 | 2 | ||
MSN II ANDA | ||||
Other Commitments [Line Items] | ||||
Number of lawsuits | 2 | |||
Number of patents allegedly infringed | patent | 3 |
Restructuring - Narrative (Deta
Restructuring - Narrative (Details) $ in Thousands | 3 Months Ended | |
Mar. 29, 2024 USD ($) lease | Mar. 31, 2023 USD ($) | |
Restructuring Cost and Reserve [Line Items] | ||
Restructuring expenses | $ 32,835 | $ 0 |
2024 Restructuring Plan | ||
Restructuring Cost and Reserve [Line Items] | ||
Restructuring expenses | $ 32,835 | |
2024 Restructuring Plan | Lease Termination | ||
Restructuring Cost and Reserve [Line Items] | ||
Number of leases | lease | 2 |
Restructuring - Restructuring A
Restructuring - Restructuring Activities (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 29, 2024 | Mar. 31, 2023 | |
Restructuring Reserve [Roll Forward] | ||
Initial Costs | $ 32,835 | $ 0 |
2024 Restructuring Plan | ||
Restructuring Reserve [Roll Forward] | ||
Beginning balance | 0 | |
Initial Costs | 32,835 | |
Non-cash Charges | (12,318) | |
Cash Payments | (13,886) | |
Ending balance | 6,631 | |
Total Costs Incurred to Date | 32,835 | |
Total Expected Plan Costs | 33,018 | |
Severance and employee-related costs | 2024 Restructuring Plan | ||
Restructuring Reserve [Roll Forward] | ||
Beginning balance | 0 | |
Initial Costs | 15,656 | |
Non-cash Charges | 0 | |
Cash Payments | (13,868) | |
Ending balance | 1,788 | |
Total Costs Incurred to Date | 15,656 | |
Total Expected Plan Costs | 15,656 | |
Contract termination and other exit costs | 2024 Restructuring Plan | ||
Restructuring Reserve [Roll Forward] | ||
Beginning balance | 0 | |
Initial Costs | 4,861 | |
Non-cash Charges | 0 | |
Cash Payments | (18) | |
Ending balance | 4,843 | |
Total Costs Incurred to Date | 4,861 | |
Total Expected Plan Costs | 5,044 | |
Asset impairment | 2024 Restructuring Plan | ||
Restructuring Reserve [Roll Forward] | ||
Beginning balance | 0 | |
Initial Costs | 12,318 | |
Non-cash Charges | (12,318) | |
Cash Payments | 0 | |
Ending balance | 0 | |
Total Costs Incurred to Date | 12,318 | |
Total Expected Plan Costs | $ 12,318 |