Cover Page
Cover Page - USD ($) | 12 Months Ended | ||
Dec. 30, 2022 | Jan. 30, 2023 | Jul. 01, 2022 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 30, 2022 | ||
Current Fiscal Year End Date | --12-30 | ||
Document Transition Report | false | ||
Entity File Number | 000-30235 | ||
Entity Registrant Name | EXELIXIS, INC. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 04-3257395 | ||
Entity Address, Address Line One | 1851 Harbor Bay Parkway | ||
Entity Address, City or Town | Alameda, | ||
Entity Address, State or Province | CA | ||
Entity Address, Postal Zip Code | 94502 | ||
City Area Code | 650 | ||
Local Phone Number | 837-7000 | ||
Title of 12(b) Security | Common Stock $.001 Par Value per Share | ||
Trading Symbol | EXEL | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Voluntary Filers | No | ||
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 | ||
ICFR Auditor Attestation Flag | true | ||
Entity Shell Company | false | ||
Entity Public Float | $ 6,831,299,691 | ||
Entity Common Stock, Shares Outstanding (in shares) | 324,087,337 | ||
Documents Incorporated by Reference | Certain portions of the registrant’s definitive proxy statement to be filed with the Securities and Exchange Commission pursuant to Regulation 14A, not later than April 29, 2023, in connection with the registrant’s 2023 Annual Meeting of Stockholders are incorporated herein by reference into Part III of this Annual Report on Form 10-K. | ||
Amendment Flag | false | ||
Document Fiscal Year Focus | 2022 | ||
Document Fiscal Period Focus | FY | ||
Entity Central Index Key | 0000939767 |
Audit Information
Audit Information | 12 Months Ended |
Dec. 30, 2022 | |
Audit Information [Abstract] | |
Auditor Name | Ernst & Young LLP |
Auditor Location | San Mateo, California |
Auditor Firm ID | 42 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 501,195 | $ 647,169 |
Short-term investments | 807,273 | 819,905 |
Trade receivables, net | 214,784 | 282,650 |
Inventory | 33,299 | 27,493 |
Prepaid expenses and other current assets | 62,211 | 57,530 |
Total current assets | 1,618,762 | 1,834,747 |
Long-term investments | 756,731 | 371,112 |
Property and equipment, net | 110,624 | 104,031 |
Deferred tax assets, net | 231,110 | 111,663 |
Goodwill | 63,684 | 63,684 |
Right-of-use assets and other | 290,578 | 131,002 |
Total assets | 3,071,489 | 2,616,239 |
Current liabilities: | ||
Accounts payable | 32,667 | 24,258 |
Accrued compensation and benefits | 77,158 | 61,969 |
Accrued clinical trial liabilities | 65,072 | 77,544 |
Rebates and fees due to customers | 50,350 | 33,700 |
Accrued collaboration liabilities | 20,188 | 86,753 |
Other current liabilities | 78,924 | 53,366 |
Total current liabilities | 324,359 | 337,590 |
Long-term portion of deferred revenue | 6,582 | 8,739 |
Long-term portion of operating lease liabilities | 190,170 | 51,272 |
Other long-term liabilities | 61,951 | 8,023 |
Total liabilities | 583,062 | 405,624 |
Commitments and contingencies (Note 11) | ||
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: 323,951 and 318,842 at December 31, 2022 and 2021, respectively | 324 | 319 |
Additional paid-in capital | 2,536,849 | 2,427,561 |
Accumulated other comprehensive loss | (14,521) | (758) |
Accumulated deficit | (34,225) | (216,507) |
Total stockholders’ equity | 2,488,427 | 2,210,615 |
Total liabilities and stockholders’ equity | $ 3,071,489 | $ 2,616,239 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 30, 2022 | Dec. 31, 2021 |
Preferred stock | ||
Par value (in dollars per share) | $ 0.001 | $ 0.001 |
Shares authorized (in shares) | 10,000,000 | 10,000,000 |
Shares issued (in shares) | 0 | 0 |
Common stock | ||
Par value (in dollars per share) | $ 0.001 | $ 0.001 |
Shares authorized (in shares) | 400,000,000 | 400,000,000 |
Shares issued (in shares) | 323,951,000 | 318,842,000 |
Shares outstanding (in shares) | 323,951,000 | 318,842,000 |
Consolidated Statements of Inco
Consolidated Statements of Income - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 30, 2022 | Dec. 31, 2021 | Jan. 01, 2021 | |
Revenues: | |||
Total revenues | $ 1,611,062 | $ 1,434,970 | $ 987,538 |
Operating expenses: | |||
Cost of goods sold | 57,909 | 52,873 | 36,272 |
Research and development | 891,813 | 693,716 | 547,851 |
Selling, general and administrative | 459,856 | 401,715 | 293,355 |
Total operating expenses | 1,409,578 | 1,148,304 | 877,478 |
Income from operations | 201,484 | 286,666 | 110,060 |
Interest income | 33,065 | 7,672 | 19,865 |
Other income (expense), net | (197) | (184) | 912 |
Income before income taxes | 234,352 | 294,154 | 130,837 |
Provision for income taxes | 52,070 | 63,091 | 19,056 |
Net income | $ 182,282 | $ 231,063 | $ 111,781 |
Net income per share: | |||
Basic (in dollars per share) | $ 0.57 | $ 0.73 | $ 0.36 |
Diluted (in dollars per share) | $ 0.56 | $ 0.72 | $ 0.35 |
Weighted-average common shares outstanding: | |||
Basic (in shares) | 321,526 | 314,884 | 308,271 |
Diluted (in shares) | 324,556 | 322,359 | 318,001 |
Net product revenues | |||
Revenues: | |||
Total revenues | $ 1,401,243 | $ 1,077,256 | $ 741,550 |
License revenues | |||
Revenues: | |||
Total revenues | 162,056 | 249,956 | 167,295 |
Collaboration services revenues | |||
Revenues: | |||
Total revenues | $ 47,763 | $ 107,758 | $ 78,693 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Income - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 30, 2022 | Dec. 31, 2021 | Jan. 01, 2021 | |
Statement of Comprehensive Income [Abstract] | |||
Net income | $ 182,282 | $ 231,063 | $ 111,781 |
Other comprehensive income (loss): | |||
Net unrealized gains (losses) on available-for-sale debt securities, net of tax impact of $3,886, $1,481, and $(394), respectively | (13,763) | (5,234) | 1,407 |
Comprehensive income | $ 168,519 | $ 225,829 | $ 113,188 |
Consolidated Statements of Co_2
Consolidated Statements of Comprehensive Income (Parenthetical) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 30, 2022 | Dec. 31, 2021 | Jan. 01, 2021 | |
Statement of Comprehensive Income [Abstract] | |||
Tax impact of available-for-sale, unrealized holding gain (loss) | $ 3,886 | $ 1,481 | $ (394) |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) shares in Thousands, $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit |
Beginning balance (in shares) at Jan. 03, 2020 | 304,831 | ||||
Beginning balance at Jan. 03, 2020 | $ 1,685,970 | $ 305 | $ 2,241,947 | $ 3,069 | $ (559,351) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net income | 111,781 | 111,781 | |||
Other comprehensive income (loss) | 1,407 | 1,407 | |||
Issuance of common stock under equity incentive and stock purchase plans (in shares) | 6,796 | ||||
Issuance of common stock under equity incentive and stock purchase plans | 24,903 | $ 7 | 24,896 | ||
Stock transactions associated with taxes withheld on equity awards | (50,018) | (50,018) | |||
Stock-based compensation | 105,070 | 105,070 | |||
Ending balance (in shares) at Jan. 01, 2021 | 311,627 | ||||
Ending balance at Jan. 01, 2021 | 1,879,113 | $ 312 | 2,321,895 | 4,476 | (447,570) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net income | 231,063 | 231,063 | |||
Other comprehensive income (loss) | (5,234) | (5,234) | |||
Issuance of common stock under equity incentive and stock purchase plans (in shares) | 7,215 | ||||
Issuance of common stock under equity incentive and stock purchase plans | 24,367 | $ 7 | 24,360 | ||
Stock transactions associated with taxes withheld on equity awards | (39,142) | (39,142) | |||
Stock-based compensation | $ 120,448 | 120,448 | |||
Ending balance (in shares) at Dec. 31, 2021 | 318,842 | 318,842 | |||
Ending balance at Dec. 31, 2021 | $ 2,210,615 | $ 319 | 2,427,561 | (758) | (216,507) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net income | 182,282 | 182,282 | |||
Other comprehensive income (loss) | (13,763) | (13,763) | |||
Issuance of common stock under equity incentive and stock purchase plans (in shares) | 5,109 | ||||
Issuance of common stock under equity incentive and stock purchase plans | 23,981 | $ 5 | 23,976 | ||
Stock transactions associated with taxes withheld on equity awards | (23,344) | (23,344) | |||
Stock-based compensation | $ 108,656 | 108,656 | |||
Ending balance (in shares) at Dec. 30, 2022 | 323,951 | 323,951 | |||
Ending balance at Dec. 30, 2022 | $ 2,488,427 | $ 324 | $ 2,536,849 | $ (14,521) | $ (34,225) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 30, 2022 | Dec. 31, 2021 | Jan. 01, 2021 | |
Cash flows from operating activities: | |||
Net income | $ 182,282 | $ 231,063 | $ 111,781 |
Adjustments to reconcile net income to net cash provided by operating activities: | |||
Depreciation | 20,875 | 13,630 | 9,141 |
Stock-based compensation | 107,574 | 119,820 | 105,070 |
Non-cash lease expense | 18,315 | 5,332 | 4,830 |
Deferred taxes | (60,358) | 46,529 | 15,265 |
Acquired in-process research and development technology | 107,250 | 14,000 | 0 |
Other, net | (525) | 9,443 | 3,035 |
Changes in operating assets and liabilities: | |||
Trade receivables, net | 66,849 | (122,324) | (42,470) |
Inventory | (11,683) | (13,209) | (21,897) |
Prepaid expenses and other assets | (28,259) | (39,875) | (25,831) |
Deferred revenue | (2,483) | 11,008 | (1,051) |
Accrued collaboration liabilities | (63,065) | 70,297 | 600 |
Accounts payable and other liabilities | 25,842 | 55,090 | 50,509 |
Net cash provided by operating activities | 362,614 | 400,804 | 208,982 |
Cash flows from investing activities: | |||
Purchases of property, equipment and other | (27,706) | (54,225) | (30,345) |
Acquired in-process research and development technology | (110,750) | (10,000) | 0 |
Purchases of investments | (1,450,716) | (1,357,168) | (1,070,269) |
Proceeds from maturities and sales of investments | 1,064,758 | 1,378,509 | 969,399 |
Net cash used in investing activities | (524,414) | (42,884) | (131,215) |
Cash flows from financing activities: | |||
Proceeds from issuance of common stock under equity incentive and stock purchase plans | 23,886 | 24,307 | 24,886 |
Taxes paid related to net share settlement of equity awards | (23,300) | (39,108) | (50,018) |
Net cash provided by (used in) financing activities | 586 | (14,801) | (25,132) |
Net (decrease) increase in cash, cash equivalents and restricted cash equivalents | (161,214) | 343,119 | 52,635 |
Cash, cash equivalents and restricted cash equivalents at beginning of period | 663,891 | 320,772 | 268,137 |
Cash, cash equivalents and restricted cash equivalents at end of period | 502,677 | 663,891 | 320,772 |
Supplemental cash flow disclosures: | |||
Cash paid for taxes | 127,870 | 12,960 | 4,115 |
Non-cash operating activities: | |||
Right-of-use assets obtained in exchange for lease obligations | 155,935 | 4,893 | 4,017 |
Non-cash investing activities: | |||
Accounts receivable for unsettled investment sales | $ 0 | $ 0 | $ 6,180 |
Organization and Summary of Sig
Organization and Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Organization Exelixis, Inc. (Exelixis, we, our or us) is an oncology 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, including 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, antibody-drug conjugates (ADCs) and other biotherapeutics. 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 62 other countries as: CABOMETYX® (cabozantinib) tablets approved both alone and in combination with Bristol-Myers Squibb Company’s (BMS) OPDIVO® (nivolumab) for advanced renal cell carcinoma (RCC), for previously treated hepatocellular carcinoma (HCC) and, currently by the FDA and European Commission (EC), for previously treated, radioactive iodine (RAI)-refractory differentiated thyroid cancer (DTC); and COMETRIQ® (cabozantinib) capsules approved for progressive, metastatic medullary thyroid cancer. 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). See “—Collaborations and Business Development Activities—Other Collaborations.” We plan to continue leveraging our operating cash flows to support the ongoing investigation of cabozantinib in phase 3 trials for new indications and the advancement of a broad array of diverse biotherapeutics and small molecule programs for the treatment of cancer exploring multiple modalities and mechanisms of action. Basis of Presentation The accompanying 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 ends on the Friday closest to December 31st. Fiscal year 2022, which was a 52-week fiscal year, ended December 30, 2022, fiscal year 2021, which was a 52-week fiscal year, ended on December 31, 2021 and fiscal year 2020, which was a 52-week fiscal year, ended January 1, 2021. For convenience, references in this report as of and for the fiscal years ended December 30, 2022 and January 1, 2021 are indicated as being as of and for the years ended December 31, 2022 and 2020, respectively. We have made reclassifications to our prior years’ Consolidated Financial Statements to conform to the current year’s presentation. These reclassifications did not impact previously reported total revenues, income from operations, net income, total assets, total liabilities, total operating, investing or financing cash flows or total stockholders’ equity. 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 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. Recently Adopted Accounting Pronouncements There were no new accounting pronouncements adopted by us since our filing of the Annual Report on Form 10-K for the year ended December 31, 2021, which could have a significant effect on our Consolidated Financial Statements. Cash, Cash Equivalents, Restricted Cash Equivalents and Investments We consider all highly liquid investments purchased with an original maturity of three months or less to be cash equivalents. Cash equivalents include high-grade, short-term investments in money market funds, certificates of deposit and marketable debt securities which are subject to minimal credit and market risk. We designate all investments in marketable debt securities as available-for-sale and therefore, report such investments at fair value, with unrealized gains and losses recorded in accumulated other comprehensive income. For securities sold prior to maturity, the cost of securities sold is based on the specific identification method. We include realized gains and losses on the sale of investments in other income, net in the accompanying Consolidated Statements of Income. We classify those investments that we do not require for use in current operations and that mature in more than 12 months as long-term investments in the accompanying Consolidated Balance Sheets. The classification of restricted cash equivalents as short-term or long-term is dependent upon the longer of the remaining term to maturity of the investment or the remaining term of the related restriction. Investment Impairment Quarterly, we assess each of our investments in available-for-sale debt securities whose fair value is below its cost basis to determine if the investment’s impairment is due to credit-related factors or noncredit-related factors. Factors considered in determining whether an impairment is credit-related include the extent to which the investment’s fair value is less than its cost basis, declines in published credit ratings, issuer default on interest or principal payments, and declines in the financial condition and near-term prospects of the issuer. If we determine a credit-related impairment exists, we will measure the credit loss based on a discounted cash flows model. Credit-related impairments on available-for-sale debt securities are recognized as an allowance for credit losses with a corresponding adjustment to other income, net in the accompanying Consolidated Statements of Income. The portion of the impairment that is not credit-related is recorded as a reduction of other comprehensive income (loss), net of applicable taxes. We have elected to exclude accrued interest from both the fair value and the amortized cost basis of the available-for-sale debt securities for the purposes of identifying and measuring an impairment. We write-off accrued interest as a reduction of interest income when an issuer has defaulted on interest payments due on a security. Fair Value Measurements We define fair value as the amounts that would be received upon sale of an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date (exit price). When determining the fair value measurements for assets and liabilities which are required to be recorded at fair value, we consider the principal or most advantageous market in which we would transact and the market-based risk measurements or assumptions that market participants would use in pricing the asset or liability, such as risks inherent in valuation techniques, transfer restrictions and credit risks. Foreign Currency Remeasurement Monetary assets and liabilities denominated in currencies other than the functional currency are remeasured using exchange rates in effect at the end of the period and related gains or losses are recorded in other income, net in the accompanying Consolidated Statements of Income. Net foreign currency gains or losses were immaterial for the years ended December 31, 2022, 2021 and 2020, respectively. Accounts Receivable Trade receivables, net, contain amounts billed to our customers for product sales, and amounts billed to our collaboration partners for development, regulatory and sales-based milestone payments, royalties on the sale of licensed products, profit-sharing arrangements, development cost reimbursements, and payments for product supply services. Our customers are primarily pharmaceutical and biotechnology companies that are located in the U.S., and collaboration partners that are located in Europe and Japan. We record trade receivables net of allowances for credit losses and chargebacks, and cash discounts for prompt payment. We apply an aging method to estimate credit losses and consider our historical loss information, adjusted to account for current economic conditions, and reasonable and supportable forecasts of future economic conditions affecting our customers. We write off trade receivables and related allowances for credit losses when it becomes probable we will not collect the amount receivable. Write-offs for the years ended December 31, 2022 and December 31, 2021 were immaterial. Inventory We value inventory at the lower of cost or net realizable value. We determine the cost of inventory using the standard-cost method, which approximates actual cost based on a first-in, first-out method. We analyze our inventory levels quarterly and write down inventory subject to expiry in excess of expected requirements, or that has a cost basis in excess of its expected net realizable value. These write downs are charged to either cost of goods sold or the cost of supplied product included in collaboration services revenues in the accompanying Consolidated Statements of Income. On a quarterly basis, we analyze our estimated production levels for the following twelve-month period, which is our normal operating cycle, and reclassify inventory we expect to use or sell in periods beyond the next twelve months into other long-term assets in the accompanying Consolidated Balance Sheets. Property and Equipment We record property and equipment at cost, net of depreciation. We compute depreciation using the straight-line method based on estimated useful lives of the assets, which ranges up to 15 years and depreciate leasehold improvements over the lesser of their estimated useful lives or the remainder of the lease term. We charge repairs and maintenance costs to expense as incurred. We periodically review property and equipment for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. We did not recognize any material impairment charges in any of the periods presented. Goodwill We recorded goodwill amounts as the excess of purchase price over identifiable net assets acquired based on their estimated fair value. We review the carrying amount of goodwill for impairment annually and whenever events or changes in circumstance indicate that the carrying value may not be recoverable. We perform our annual assessment of the recoverability of our goodwill as of the first day of our fourth quarter. The assessment of recoverability may first consider qualitative factors to determine whether the existence of events or circumstances leads to a determination that it is more-likely-than-not that the fair value of a reporting unit is less than its carrying amount. We perform a quantitative assessment if the qualitative assessment results in a more-likely-than-not determination or if a qualitative assessment is not performed. The quantitative assessment considers whether the carrying amount of a reporting unit exceeds its fair value, in which case an impairment charge is recorded for the amount by which the carrying amount of a reporting unit exceeds its fair value, limited to the goodwill balance. We operate in one business segment, which is also considered to be our sole reporting unit and therefore, goodwill is tested for impairment at the enterprise level. We did not recognize any impairment charges in any of the periods presented. Long-Lived Assets The carrying value of our long-lived assets, which includes property and equipment, right-of-use assets and leasehold improvements, is reviewed for impairment whenever events or changes in circumstances indicate that the carrying value of the asset may not be recoverable. Should there be an indication of impairment, we test for recoverability by comparing the estimated undiscounted future cash flows expected to result from the use of the asset to the carrying amount of the asset or asset group. If the asset or asset group is determined to be impaired, any excess of the carrying value of the asset or asset group over its estimated fair value is recognized as an impairment loss. Revenue We account for revenues under the guidance of ASU Topic 606, Revenues from Contracts with Customers (Topic 606). Under Topic 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration to which the entity is entitled to in exchange for those goods or services. To determine revenue recognition for arrangements that are within the scope of Topic 606, we perform the following five steps: (1) identify the contract(s) with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when (or as) we satisfy a performance obligation. We only apply the five-step model to contracts when it is probable that we will collect the consideration we are entitled to in exchange for the goods or services we transfer to the customer. Net Product Revenues We sell our products principally to specialty distributors and specialty pharmacy providers, or collectively, our Customers. These Customers subsequently resell our products to health care providers and patients. In addition to distribution agreements with Customers, we enter into arrangements with health care providers and payors that provide for government-mandated and/or privately-negotiated rebates, chargebacks and discounts with respect to the purchase of our products. Revenues from product sales are recognized when the Customer obtains control of our product, which occurs at a point in time, typically upon delivery to the Customer. Product Sales Discounts and Allowances We record revenues from product sales at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established primarily from discounts, chargebacks, rebates, co-pay assistance, returns and other allowances that are offered within contracts between us and our Customers, health care providers, payors and other indirect customers relating to the sales of our products. These reserves are based on the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (if the amount is payable to the Customer) or a current liability (if the amount is payable to a party other than a Customer). Where appropriate, these estimates take into consideration a range of possible outcomes that are probability-weighted for relevant factors such as our historical experience, current contractual and statutory requirements, specific known market events and trends, industry data and forecasted Customer buying and payment patterns. Overall, these reserves reflect our best estimates of the amount of consideration to which we are entitled based on the terms of our contracts. The amount of variable consideration that is included in the transaction price may be constrained, and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. Actual amounts of consideration ultimately received may differ from our estimates. If actual results in the future vary from our estimates, we will adjust these estimates, which would affect net product revenues and earnings in the period such variances become known. Chargebacks: Chargebacks are discounts that occur when contracted Customers purchase directly from a specialty distributor. Contracted Customers, which currently consist primarily of Public Health Service institutions, Federal government entities purchasing via the Federal Supply Schedule, Group Purchasing Organizations, and health maintenance organizations, generally purchase the product at a discounted price. The specialty distributor, in turn, charges back to us the difference between the price initially paid by the specialty distributor and the discounted price paid to the specialty distributor by the Customer. The allowance for chargebacks is based on actual chargebacks received and an estimate of sales to contracted Customers. Discounts for Prompt Payment: Our Customers in the U.S. receive a discount of 2% for prompt payment. We expect our Customers will earn 100% of their prompt payment discounts and, therefore, we deduct the full amount of these discounts from total product sales when revenues are recognized. Rebates: Allowances for rebates include mandated discounts under the Medicaid Drug Rebate Program, other government programs and commercial contracts. Rebate amounts owed after the final dispensing of the product to a benefit plan participant are based upon contractual agreements or legal requirements with public sector benefit providers, such as Medicaid. The allowance for rebates is based on statutory or contractual discount rates and expected utilization. Our estimates for the expected utilization of rebates are based on Customer and payer data received from the specialty pharmacies and distributors and historical utilization rates. Rebates are generally invoiced by the payer and paid in arrears, such that the accrual balance consists of an estimate of the amount expected to be incurred for the current quarter’s shipments to our Customers, plus an accrual balance for known prior quarters’ unpaid rebates. If actual future rebates vary from estimates, we may need to adjust our accruals, which would affect net product revenues in the period of adjustment. Allowances for rebates also include amounts related to the Medicare Part D Coverage Gap Discount Program. In the U.S. during 2020, the Medicare Part D prescription drug benefit mandated participating manufacturers to fund 70% of the Medicare Part D insurance coverage gap for prescription drugs sold to eligible patients. Our estimates for expected Medicare Part D coverage gap amounts are based on Customer and payer data received from specialty pharmacies and distributors and historical utilization rates. Funding of the coverage gap is invoiced and paid in arrears so that the accrual balance consists of an estimate of the amount expected to be incurred for the current quarter’s shipments to Customer, plus an accrual balance for known prior quarters’ unpaid claims. If actual future funding varies from estimates, we may need to adjust our accruals, which would affect net product revenues in the period of adjustment. Co-payment Assistance: Patients who have commercial insurance and meet certain eligibility requirements may receive co-payment assistance. We accrue a liability for co-payment assistance based on actual program participation and estimates of program redemption using Customer data provided by the specialty distributor that administers the copay program. Other Customer Credits: We pay fees to our Customers for account management, data management and other administrative services. To the extent the services received are distinct from the sale of products to the Customer, we classify these payments in selling, general and administrative expenses in our Consolidated Statements of Income. Collaboration Revenues We assess whether our collaboration agreements are subject to ASC Topic 808, Collaborative Arrangements (Topic 808) based on whether they involve joint operating activities and whether both parties have active participation in the arrangement and are exposed to significant risks and rewards. To the extent that the arrangement falls within the scope of Topic 808, we apply by analogy the unit of account guidance under Topic 606 to identify distinct performance obligations, and then determine whether a customer relationship exists for each distinct performance obligation. If we determine a performance obligation within the arrangement is with a customer, we apply the guidance in Topic 606. If a portion of a distinct bundle of goods or services within an arrangement is not with a customer, then the unit of account is not within the scope of Topic 606, and the recognition and measurement of that unit of account shall be based on analogy to authoritative accounting literature or, if there is no appropriate analogy, a reasonable, rational, and consistently applied accounting policy election. We enter into collaboration arrangements, under which we license certain rights to our intellectual property to third parties. The terms of these arrangements typically include payments to us for one or more of the following: nonrefundable up-front license fees; development, regulatory and sales-based milestone payments; product supply services; development cost reimbursements; profit-sharing arrangements; and royalties on net sales of licensed products. As part of the accounting for these arrangements, we develop assumptions that require judgment to determine the standalone selling price for each performance obligation identified in the contract. These key assumptions may include forecasted revenues, clinical development timelines and costs, reimbursement rates for personnel costs, discount rates and probabilities of technical and regulatory success. Up-front License Fees: If the license to our intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, we recognize revenues from nonrefundable up-front fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license, which generally occurs at or near the inception of the contract. For licenses that are bundled with other promises, we utilize judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenues from nonrefundable up-front fees. We evaluate the measure of progress at the end of each reporting period and, if necessary, adjust the measure of performance and related revenue recognition. Regulatory and Development Milestone Payments: At the inception of each arrangement that includes development milestone payments, we evaluate whether the milestones are considered probable of being reached and estimate the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within our or the licensee’s control, such as regulatory approvals, are not considered probable of being achieved until uncertainty associated with the approvals has been resolved. The transaction price is then allocated to each performance obligation, on a relative standalone selling price basis, for which we recognize revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, we re-evaluate the probability of achieving such development and regulatory milestones and any related variable consideration constraint, and if necessary, adjust our estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis. Product Supply Services: Arrangements that include a promise for the future supply of drug product for either clinical development or commercial supply at the licensee’s discretion are generally considered as options. We assess if these options provide a material right to the licensee and if so, they are accounted for as separate performance obligations. Development Cost Reimbursements: Our collaboration arrangements may include promises of future clinical development and drug safety services, as well as participation on certain joint committees. When such services are provided to a customer, and they are distinct from the licenses provided to our collaboration partners, these promises are accounted for as a separate performance obligation, which we estimate using internal development costs incurred and projections through the term of the arrangements. We record revenues for these services as the performance obligations are satisfied over time based on measure of progress. However, if we conclude that our collaboration partner is not a customer for those collaborative research and development activities, we present such payments as a reduction of research and development expenses. Profit-sharing Arrangements: Under the terms of our collaboration agreement with Genentech for cobimetinib, we are entitled to a share of U.S. profits and losses received in connection with the commercialization of cobimetinib. We account for this arrangement in accordance with Topic 606. We have determined that we are an agent under the agreement and therefore revenues are recorded net of costs incurred. We record revenues for the variable consideration associated with the profits and losses under the collaboration agreement when it is probable that a significant reversal in the amount of cumulative revenues recognized will not occur. Royalty and Sales-based Milestone Payments: For arrangements that include royalties and sales-based milestone payments, including milestone payments earned for the first commercial sale of a product, the license is deemed to be the predominant item to which such payments relate and we recognize revenues at the later of when the related sales occur or when the performance obligation to which the royalty has been allocated has been satisfied. Cost of Goods Sold Cost of goods sold is related to our product revenues and consists primarily of a 3% royalty we are required to pay on all net sales of any product incorporating cabozantinib, the cost of manufacturing, indirect labor costs, write-downs related to expiring and excess inventory, shipping and other third-party logistics and distribution costs for our product. We consider regulatory approval of product candidates to be uncertain and product manufactured prior to regulatory approval may not be sold unless regulatory approval is obtained. As such, the manufacturing costs for product candidates incurred prior to regulatory approval are not capitalized as inventory but are expensed as research and development costs. Research and Development Expenses Research and development expenses consist of (1) direct and indirect internal costs for drug discovery; (2) upfront license and project initiation fees, license option fees and option exercise fees, funded research and milestone payments incurred or probable to be incurred for our in-licensing arrangements with our collaboration partners for research programs in development and prior to regulatory approval; and (3) development costs associated with our clinical trial projects, which include fees paid to Contract Research Organizations (CRO) performing work on our behalf. Our clinical trial projects have been executed with support from third-party CROs, who specialize in conducting and managing global clinical trials. We accrue expenses for clinical trial activities performed by the CROs based upon the estimated amount of work completed on each trial. For clinical trial expenses, the significant factors used in estimating accruals include direct CRO costs, the number of patients enrolled, the number of active clinical sites involved, the duration for which the patients will be enrolled in the trial and patient out of pocket costs. We monitor patient enrollment levels and related activities to the extent possible through CRO meetings and correspondence, internal reviews and review of contractual terms. We base our estimates on the best information available at the time. However, additional information may become available to us which may allow us to make a more accurate estimate in future periods. In this event, we may be required to record adjustments to research and development expenses in future periods when the actual level of activity becomes more certain. As described further above, certain payments made to us from our collaboration partners may be presented as a reduction of research and development expense. Leases We determine if an arrangement includes a lease at the inception of the agreement. For each of our lease arrangements, we record a right-of-use asset representing our right to use an underlying asset for the lease term and a lease liability representing our obligation to make lease payments. Operating lease right-of-use assets and liabilities are recognized at the lease commencement date based on the net present value of lease payments over the lease term. In determining the discount rate used to calculate the net present value of lease payments, we use our incremental borrowing rate based on the information available at the lease commencement date. Our leases may include options to extend or terminate the lease which are included in the lease term when it is reasonably certain that we will exercise any such options. Lease expense for our operating leases is recognized on a straight-line basis over the lease term. We have elected not to apply the recognition requirements of ASU 2016-02 , Leases (Topic 842) for short-term leases. Advertising Advertising expenses were $41.6 million, $31.8 million and $25.1 million for the years ended December 31, 2022, 2021 and 2020, respectively. We expense the costs of advertising, including promotional expenses, as incurred. Advertising expenses are recorded in selling, general and administrative expenses. Stock-Based Compensation We account for stock-based payments to employees, including grants of service-based restricted stock units (RSUs), performance-based restricted stock units (PSUs), service-based stock options and purchases under our 2000 Employee Stock Purchase Plan (ESPP) in accordance with ASC 718, Compensation-Stock Compensation , which requires that stock-based payments (to the extent they are compensatory) be recognized in our Consolidated Statements of Income based on their fair values. We account for forfeitures of stock-based awards as they occur. The expense for stock-based compensation is based on the grant date fair value of the award. The grant date fair value of RSUs and PSUs are estimated as the value of the underlying shares of our common stock. The grant date fair values are estimated using a Monte Carlo simulation pricing model for certain PSUs and RSUs with market vesting conditions and a Black-Scholes Merton option pricing model for stock options. Both pricing models require the input of subjective assumptions. These variables include, but are not limited to, the expected volatility of |
Revenues
Revenues | 12 Months Ended |
Dec. 30, 2022 | |
Revenue from Contract with Customer [Abstract] | |
REVENUES | REVENUES Revenues consisted of the following (in thousands): Year Ended December 31, 2022 2021 2020 Product revenues: Gross product revenues $ 1,951,169 $ 1,452,913 $ 962,591 Discounts and allowances (549,926) (375,657) (221,041) Net product revenues 1,401,243 1,077,256 741,550 Collaboration revenues: License revenues 162,056 249,956 167,295 Collaboration services revenues 47,763 107,758 78,693 Total collaboration revenues 209,819 357,714 245,988 Total revenues $ 1,611,062 $ 1,434,970 $ 987,538 Net product revenues and license revenues are recorded in accordance with Topic 606. License revenues include the recognition of the portion of milestone payments allocated to the transfer of intellectual property licenses for which it had become probable in the current period that the milestone would be achieved and a significant reversal of revenues would not occur, as well as royalty revenues and our share of profits under our collaboration agreement with Genentech. Collaboration services revenues were recorded in accordance with Topic 808. 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): Year Ended December 31, 2022 2021 2020 CABOMETYX $ 1,375,909 $ 1,054,050 $ 718,687 COMETRIQ 25,334 23,206 22,863 Net product revenues $ 1,401,243 $ 1,077,256 $ 741,550 The percentage of total revenues by customer who individually accounted for 10% or more of our total revenues were as follows: Year Ended December 31, 2022 2021 2020 Affiliates of AmerisourceBergen Corporation 18 % 14 % 11 % Affiliates of McKesson Corporation 17 % 14 % 12 % Affiliates of CVS Health Corporation 17 % 14 % 14 % Ipsen Pharma SAS 10 % 21 % 15 % Accredo Health, Incorporated 10 % 9 % 9 % Affiliates of Optum Specialty Pharmacy 10 % 8 % 11 % As of December 31, 2022 and 2021, the percentage of trade receivables by customer who individually accounted for 10% or more of our trade receivables were as follows: December 31, 2022 2021 Affiliates of McKesson Corporation 22 % 10 % Ipsen Pharma SAS 20 % 50 % Affiliates of AmerisourceBergen Corporation 18 % 11 % Affiliates of CVS Health Corporation 18 % 9 % Cardinal Health, Inc. 11 % 6 % Total revenues by geographic region were as follows (in thousands): Year Ended December 31, 2022 2021 2020 U.S. $ 1,413,743 $ 1,089,396 $ 752,890 Europe 168,592 302,073 151,631 Japan 28,727 43,501 83,017 Total revenues $ 1,611,062 $ 1,434,970 $ 987,538 Total revenues include net product revenues attributed to geographic regions based on ship-to location and license and collaboration services revenues attributed to geographic regions based on the location of our collaboration partners’ headquarters. 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, 2020 $ 9,853 $ 3,279 $ 17,404 $ 30,536 Provision related to sales made in: Current period 243,119 30,728 100,361 374,208 Prior periods (64) (111) 1,624 1,449 Payments and customer credits issued (238,283) (25,021) (94,564) (357,868) Balance at December 31, 2021 14,625 8,875 24,825 48,325 Provision related to sales made in: Current period 355,865 50,312 143,516 549,693 Prior periods 611 (169) (209) 233 Payments and customer credits issued (344,220) (44,094) (132,706) (521,020) Balance at December 31, 2022 $ 26,881 $ 14,924 $ 35,426 $ 77,231 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 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. As of December 31, 2022 and 2021, respectively, contract assets are primarily related to contract assets from Ipsen Pharma SAS (Ipsen) and c ontract liabilities are primarily related to deferred revenues from Takeda Pharmaceutical Company Limited (Takeda). Contract assets and liabilities were as follows (in thousands): December 31, 2022 2021 Contract assets (1) $ 1,659 $ 1,665 Contract liabilities: Current portion (2) $ 7,488 $ 7,814 Long-term portion (3) 6,582 8,739 Total contract liabilities $ 14,070 $ 16,553 ____________________ (1) Presented in other long-term assets in the accompanying Consolidated Balance Sheets. (2) Presented in other current liabilities in the accompanying Consolidated Balance Sheets. (3) Presented in the long-term portion of deferred revenues in the accompanying Consolidated Balance Sheets. During the years ended December 31, 2022, 2021 and 2020, we recognized $8.1 million, $8.5 million and $9.2 million, respectively, in revenues that were included in the beginning deferred revenues balance for those years. During the years ended December 31, 2022, 2021 and 2020, we recognized $161.6 million, $148.7 million and $169.7 million, respectively, in revenues for performance obligations satisfied in previous periods. Such revenues were primarily related to milestone and royalty payments allocated to our license performance obligations for our collaborations with Ipsen, Takeda, Daiichi Sankyo and Genentech. As of December 31, 2022, $73.0 million of the combined transaction prices for our Ipsen and Takeda collaborations were allocated to performance obligations that had not yet been satisfied. See “Note 3. Collaboration Agreements— Cabozantinib Collaborations — Performance Obligations and Transaction Prices for our Ipsen and Takeda Collaborations” for additional information about the expected timing to satisfy these performance obligations. |
Collaboration Agreements And Bu
Collaboration Agreements And Business Development Activities | 12 Months Ended |
Dec. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
COLLABORATION AGREEMENTS AND BUSINESS DEVELOPMENT ACTIVITIES | COLLABORATION AGREEMENTS AND BUSINESS DEVELOPMENT ACTIVITIES We have established multiple collaborations with leading 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. Under these collaborations, we are generally entitled to receive milestone and royalty payments, and for certain collaborations, to receive payments for product supply services, development cost reimbursements, and/or profit-sharing payments. See “Note 2. Revenues” for additional information on revenues recognized under our collaboration agreements during the years ended December 31, 2022, 2021 and 2020. Cabozantinib Commercial Collaborations Ipsen Collaboration Description of the 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. During the second quarter of 2021, Ipsen opted into and is now co-funding the development costs for COSMIC-311, our phase 3 pivotal trial evaluating cabozantinib versus placebo in patients with RAI-refractory DTC who have progressed after up to two VEGF receptor-targeted therapies. Under the collaboration agreement, Ipsen i s obligated to reimburse us for their share of COSMIC-311 global development costs, as well as an additional payment calculated as a percentage of such costs, triggered by the timing of the exercise of its option. We determined that the decision to opt in and co-fund the development costs for COSMIC-311 represented a contract modification for additional distinct services at their standalone selling price and therefore was treated as a separate contract under Topic 606. Accordingly, collaboration services revenues for the year ended December 31, 2021, includes a cumulative catch-up of $43.2 million for Ipsen’s share of global development costs incurred since the beginning of the study and through the opt-in date. Unless earlier terminated, the collaboration agreement has a term that continues, on a product-by-product and country-by-country basis, until the latter of (1) the expiration of patent claims related to cabozantinib, (2) the expiration of regulatory exclusivity covering cabozantinib or (3) ten years after the first commercial sale of cabozantinib, other than COMETRIQ. A related supply agreement will continue in effect until expiration or termination of the collaboration agreement. The collaboration agreement may be terminated for cause by either party based on uncured material breach of either the collaboration agreement or the supply agreement by the other party, bankruptcy of the other party or for safety reasons. We may terminate the collaboration agreement if Ipsen challenges or opposes any patent covered by the collaboration agreement. Ipsen may terminate the collaboration agreement if the FDA or European Medicines Agency orders or requires substantially all cabozantinib clinical trials to be terminated. Ipsen also has the right to terminate the collaboration agreement on a region-by-region basis after the first commercial sale of cabozantinib in advanced RCC in the given region. Upon termination by either party, all licenses granted by us to Ipsen will automatically terminate, and, except in the event of a termination by Ipsen for our material breach, the licenses granted by Ipsen to us shall survive such termination and shall automatically become worldwide, or, if Ipsen were to terminate only for a particular region, then for the terminated region. Following termination by us for Ipsen’s material breach, or termination by Ipsen without cause or because we undergo a change of control by a party engaged in a competing program, Ipsen is prohibited from competing with us for a period of time. Consideration under the Collaboration In consideration for the exclusive license and other rights contained in the collaboration agreement, including commercialization rights in Canada, we received aggregate upfront payments of $210.0 million from Ipsen in 2016. As of December 31, 2022, we have achieved aggregate milestones of $489.5 million related to regulatory, development and sales-based threshold by Ipsen since the inception of the collaboration agreement, including $27.0 million, $112.5 million, and $20.0 million in milestones achieved during the years ended December 31, 2022, 2021 and 2020, respectively. As of December 31, 2022, we are eligible to receive additional regulatory and development milestone payments from Ipsen totaling an aggregate of $19.5 million, as well as sales-based milestones, including milestone payments earned for the first commercial sale of a product, of up to $350.0 million and CAD$26.5 million. We excluded these milestones from the transaction price as of December 31, 2022 because we determined such payments to be fully constrained under Topic 606 due to the fact that it was not probable that a significant reversal of cumulative revenue would not occur, given the inherent uncertainty of success with these milestones. We will adjust the constraint applied to the variable consideration at each reporting period as uncertain events are resolved or other changes in circumstances occur. See “—Performance Obligations and Transaction Prices for our Ipsen and Takeda Collaborations” , below, for additional information related to the revenue recognition for this collaboration. We also receive royalty revenues on the net sales of cabozantinib by Ipsen outside of t he U.S. and Japan. During the year ended December 31, 2022 and going forward, we are entitled to receive a tiered royalty of 22% to 26% on annual net sales, with separate tiers for Canada; these royalty tiers reset each calendar year. Any variable consideration related to royalties and sales-based milestones will be recognized when the related sales occur as these amounts have been determined to relate to the relevant transferred license and therefore are recognized as the related sales occur. We are required to pay a 3% royalty on all net sales of any product incorporating cabozantinib, including net sales by Ipsen. We are responsible for funding cabozantinib-related development costs for those trials in existence at the time we entered into the collaboration agreement with Ipsen; global development costs for additional trials are shared between the parties, with Ipsen reimbursing us for 35% of such costs, provided Ipsen chooses to opt into such trials. Ipsen has opted into and is co-funding certain clinical trials, including: CheckMate-9ER, COSMIC-021, COSMIC-311, COSMIC-312, CONTACT-01 and CONTACT-02. We remain responsible for manufacturing and supply of cabozantinib for all development and commercialization activities under the collaboration agreement. Relatedly, we entered into a supply agreement with Ipsen to supply finished, labeled drug product to Ipsen for distribution in the territories outside of the U.S. and Japan for the term of the collaboration agreement as well as a quality agreement that provides respective quality responsibilities for the aforementioned supply. The product is supplied at our cost, as defined in the agreement. This agreement also requires us to maintain the global safety database for cabozantinib. To meet our obligations to regulatory authorities for the reporting of safety data from territories outside of U.S. and Japan from sources other than our sponsored global clinical development trials, we rely on data collected and reported to us by Japan. Revenues from the Collaboration Revenues under the collaboration agreement with Ipsen were as follows (in thousands): Year Ended December 31, 2022 2021 2020 License revenues $ 133,732 $ 207,982 $ 93,495 Collaboration services revenues 34,860 94,091 58,136 Total $ 168,592 $ 302,073 $ 151,631 During the year ended December 31, 2022, we recognized $25.8 million in revenues in connection with two regulatory milestones totaling $27.0 million upon approval by the EC and Health Canada, of cabozantinib a monotherapy for the treatment of adult patients with locally advanced or metastatic DTC, refractory or not eligible to RAI who have progressed during or after prior systemic therapy. As of December 31, 2022, $35.4 million of the transaction price was allocated to our research and development services performance obligation that has not yet been satisfied. Takeda Collaboration Description of the Collaboration In January 2017, we entered into a collaboration and license agreement with Takeda, which was subsequently amended effective March 2018, May 2019 and September 2020, to, among other things, modify the amount of reimbursements we receive, for costs associated with our required pharmacovigilance activities and milestones we are eligible to receive, as well as modify certain cost-sharing obligations related to the Japan-specific development costs associated with CONTACT-01 and CONTACT-02. Takeda is responsible for a portion of the costs associated with the cabozantinib development plan’s current and future trials, provided Takeda opts into such trials, and 100% of costs associated with the cabozantinib development activities that are exclusively for the benefit of Japan. Takeda has opted into and is co-funding CheckMate-9ER, certain cohorts of COSMIC-021, CONTACT-01 and CONTACT-02. Under the collaboration agreement, as amended, Takeda has exclusive commercialization rights for current and potential future cabozantinib indications in Japan, and the parties have agreed to collaborate on the clinical development of cabozantinib in Japan. The operation and strategic direction of the parties’ collaboration is governed through a joint executive committee and appropriate subcommittees. Unless earlier terminated, the collaboration agreement has a term that continues, on a product-by-product basis, until the earlier of (1) two years after first generic entry with respect to such product in Japan or (2) the later of (A) the expiration of patent claims related to cabozantinib and (B) the expiration of regulatory exclusivity covering cabozantinib in Japan. The collaboration agreement may be terminated for cause by either party based on uncured material breach by the other party, bankruptcy of the other party or for safety reasons. We may terminate the agreement if Takeda challenges or opposes any patent covered by the collaboration agreement. After the commercial launch of cabozantinib in Japan, Takeda may terminate the collaboration agreement upon twelve months’ prior written notice following the third anniversary of the first commercial sale of cabozantinib in Japan. Upon termination by either party, all licenses granted by us to Takeda will automatically terminate, and the licenses granted by Takeda to us shall survive such termination and shall automatically become worldwide. Consideration under the Collaboration In consideration for the exclusive license and other rights contained in the collaboration agreement, we received an upfront payment of $50.0 million from Takeda in 2017. As of December 31, 2022, we have also achieved regulatory and development milestones in the aggregate of $127.0 million since the inception of the collaboration agreement, including $0, $35.0 million and $66.0 million in milestones achieved during the years ended December 31, 2022, 2021 and 2020, respectively. Under the collaboration agreement, as amended in 2020, we are eligible to receive additional regulatory and development milestone payments, without contractual limit, for additional potential future indications. We are further eligible to receive commercial milestones, including milestone payments earned for the first commercial sale of a product, of $119.0 million. We excluded these milestones from the transaction price as of December 31, 2022 because we determined such payments to be fully constrained under Topic 606 due to the fact that it was not probable that a significant reversal of cumulative revenue would not occur, given the inherent uncertainty of success with these milestones. We will adjust the constraint applied to the variable consideration at each reporting period as uncertain events are resolved or other changes in circumstances occur. We also receive royalty revenues on the net sales of cabozantinib in Japan. We are entitled to receive a tiered royalty of 15% to 24% on the initial $300.0 million of net sales, and following this initial $300.0 million of net sales, we are then entitled to receive a tiered royalty of 20% to 30% on annual net sales thereafter; these 20% to 30% royalty tiers reset each calendar year. Any variable consideration related to royalties and sales-based milestones will be recognized when the related sales occur as these amounts have been determined to relate to the relevant transferred license and therefore are recognized as the related sales occur. We are required to pay a 3% royalty on all net sales of any product incorporating cabozantinib, including net sales by Takeda. Under the collaboration agreement, we are responsible for the manufacturing and supply of cabozantinib for all development and commercialization activities under the collaboration agreement. Relatedly, we entered into a clinical supply agreement covering the supply of cabozantinib to Takeda for the term of the collaboration agreement, as well as a quality agreement that provides respective quality responsibilities for the aforementioned supply. Furthermore, at the time we entered into the collaboration agreement, the parties also entered into a safety data exchange agreement, which defines each partner’s responsibility for safety reporting. This agreement also requires us to maintain the global safety database for cabozantinib. To meet our obligations to regulatory authorities for the reporting of safety data from Japan from sources other than our sponsored global clinical development trials, we rely on data collected and reported to us by Takeda. Revenues from the Collaboration Collaboration services revenues under the collaboration agreement with Takeda were as follows (in thousands): Year Ended December 31, 2022 2021 2020 License revenues $ 11,335 $ 26,058 $ 61,115 Collaboration services revenues 12,903 13,667 20,557 Total collaboration revenues $ 24,238 $ 39,725 $ 81,672 As of December 31, 2022, $37.6 million of the transaction price was allocated to our research and development services performance obligations that have not yet been satisfied. Performance Obligations and Transaction Prices for our Ipsen and Takeda Collaborations There is one remaining performance obligation for the Ipsen collaboration agreement: the research and development services, which includes certain committed studies for the development of cabozantinib, pharmacovigilance services and participation on various joint committees (as defined in the specific collaboration agreements). As part of the original contract, we also had a performance obligation associated with exclusive license for the commercialization and further development of cabozantinib, which was transferred in 2016. There are two remaining performance obligations for the Takeda collaboration agreement: (1) the research and development services, which includes certain committed studies for the development of cabozantinib, pharmacovigilance services and participation on various joint committees (as defined in the specific collaboration agreements) and (2) the research and development services associated with CONTACT-01, CONTACT-02, and certain cohorts of COSMIC-021 studies. As part of the original contract, we had a performance obligation associated with the exclusive license for the commercialization and further development of cabozantinib, which was transferred in 2017. We have allocated the transaction price for each of these collaborations to the originally identified performance obligations based on our best estimate of their relative standalone selling price. For the licenses, the estimate of the relative standalone selling price was determined using a discounted cash flow valuation utilizing forecasted revenues and costs. For research and development services the estimate of the relative standalone selling price was determined using an adjusted market assessment approach that relies on internal and external costs and market factors. The portion of the transaction price allocated to our license performance obligation is recorded immediately as our license represents functional intellectual property that was transferred at a point in time. The portion of the transaction price allocated to our research and development services performance obligation is being recognized as revenue using the inputs method based on our internal development projected cost estimates through the current estimated patent expiration of cabozantinib in the European Union for the Ipsen collaboration and Japan for the Takeda collaboration, both of which are early 2030. We adjust the constraint applied to the variable consideration for the collaboration agreements in each reporting period as uncertain events are resolved or other changes in circumstances occur and we allocate those changes in the transaction price between our performance obligations. During the years ended December 31, 2022, 2021 and 2020, the transaction price of the Ipsen and Takeda collaboration agreements increased as a result of the achievement of various milestones, and the reimbursements of research and development services related to committed and opt-in studies. We further updated the transaction price based upon the actual research and development services performed during the period and changes in our estimated reimbursements for our future research and development services. The portion of the increase in transaction price that was allocated to the previously satisfied performance obligations for the transfer of an intellectual property license was recognized during the period and the portion allocated to research and development services will be recognized in future periods as those services are delivered through early 2030. As of December 31, 2022, variable consideration related to the remaining unearned regulatory and development milestones for both agreements remained constrained due to the fact that it was not probable that a significant reversal of cumulative revenue would not occur. Cabozantinib Development Collaborations BMS In February 2017, we entered into a clinical trial collaboration agreement with BMS for the purpose of exploring the therapeutic potential of cabozantinib in combination with BMS’s immune checkpoint inhibitors (ICIs), nivolumab and/or ipilimumab, to treat a variety of types of cancer. As part of the collaboration, we are evaluating the triplet combination of cabozantinib, nivolumab and ipilimumab as a treatment option for RCC in the COSMIC-313 trial. Under the collaboration agreement with BMS, we may also evaluate these combinations in other phase 3 pivotal trials in various other tumor types. Under the collaboration agreement with BMS, as amended, each party granted to the other a non-exclusive, worldwide (within the collaboration territory as defined in the collaboration agreement and its supplemental agreements), non-transferable, royalty-free license to use the other party’s compounds in the conduct of each clinical trial. The parties’ efforts are governed through a joint development committee established to guide and oversee the collaboration’s operation. Each trial is conducted under a combination Investigational New Drug application, unless otherwise required by a regulatory authority. Each party is responsible for supplying finished drug product for the applicable clinical trial, and responsibility for the payment of costs for each such trial will be determined on a trial-by-trial basis. Unless earlier terminated, the collaboration agreement will remain in effect until the completion of all clinical trials under the collaboration, all related trial data has been delivered to both parties and the completion of any then agreed upon analysis. The collaboration agreement may be terminated for cause by either party based on uncured material breach by the other party, bankruptcy of the other party or for safety reasons. Upon termination by either party, the licenses granted to each party to conduct a combined therapy trial will terminate. F. Hoffmann-La Roche Ltd. (Roche) Collaboration In February 2017, we entered into a master clinical supply agreement with Roche for the purpose of evaluating cabozantinib and Roche’s ICI, atezolizumab, in locally advanced or metastatic solid tumors. Under this agreement with Roche, in June 2017, we initiated COSMIC-021, a phase 1b dose escalation study that is evaluating the safety and tolerability of cabozantinib in combination with Roche’s atezolizumab in patients with locally advanced or metastatic solid tumors, and in December 2018, we initiated COSMIC-312, a multicenter, randomized, controlled phase 3 pivotal trial evaluating cabozantinib in combination with atezolizumab versus sorafenib in previously untreated advanced HCC. We are the sponsor of both trials, and Roche is providing atezolizumab free of charge. In December 2019, we entered into a joint clinical research agreement with Roche for the purpose of further evaluating the combination of cabozantinib with atezolizumab in patients with locally advanced or metastatic solid tumors, including in the phase 3 pivotal clinical trials in advanced non-small cell lung cancer (CONTACT-01), metastatic castration-resistant prostate cancer (CONTACT-02) and RCC (CONTACT-03). If a party to the joint clinical research agreement proposes any additional combined therapy trials beyond these phase 3 pivotal trials, the joint clinical research agreement provides that such proposing party must notify the other party and that if agreed to, any such additional combined therapy trial will become part of the collaboration, or if not agreed to, the proposing party may conduct such additional combined therapy trial independently, subject to specified restrictions set forth in the joint clinical research agreement. In July 2020, a supplement to the joint clinical research agreement was signed amongst us, Roche and Takeda due to Takeda opting into fund the combined therapy trial of CONTACT-01 sponsored by Roche. Chugai was added as an affiliate of Roche. All parties including Chugai conduct combined therapy trials in Japan upon the terms of the joint clinical research agreement. Under the joint clinical research agreement, each party granted to the other a non-exclusive, worldwide (excluding, in our case, territory already the subject of a license by us to Takeda), non-transferable, royalty-free license, with a right to sublicense (subject to limitations), to use the other party’s intellectual property and compounds solely as necessary for the party to perform its obligations under the joint clinical research agreement. The parties’ efforts will be governed through a joint steering committee established to guide and oversee the collaboration and the conduct of the combined therapy trials. Each party will be responsible for providing clinical supply of their drug for all combined therapy trials, and the cost of the supply will be borne by such party. The clinical trial expenses for each combined therapy trial agreed to be conducted jointly under the joint clinical research agreement will be shared equally between the parties, and the clinical trial expenses for each additional combined therapy trial not agreed to be conducted jointly under the joint clinical research agreement will be borne by the proposing party, except that the cost of clinical supply for all combined therapy trials will be borne by the party that owns the applicable product. We determined the contract is within the scope of Topic 808 as it involves joint operating activities where both parties have active participation in the arrangement and are exposed to significant risks and rewards. Payments between us and Roche under this arrangement are not subject to other accounting literature. Payments due to Roche for our share of clinical trial costs incurred by Roche will be recorded as research and development expense and payments due from Roche for their share of clinical trial costs incurred by us will be recorded as a reduction of research and development expense. Unless earlier terminated, the joint clinical research agreement provides that it will remain in effect until the completion of all combined therapy trials under the collaboration, the delivery of all related trial data to both parties, and the completion of any then agreed-upon additional analyses. The joint clinical research agreement may be terminated for cause by either party based on any uncured material breach by the other party, bankruptcy of the other party or for safety reasons. Upon termination by either party, the licenses granted to each party will terminate upon completion of any ongoing activities under the joint clinical research agreement. GSK and Royalty Pharma In October 2002, we established a product development and commercialization collaboration agreement with GlaxoSmithKline (GSK), that required us to pay a 3% royalty to GSK on the total worldwide net sales of any product incorporating cabozantinib 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 total net sales of any product containing cabozantinib for non-U.S. markets for the full term of the royalty and for U.S. market through September 2026, after which time U.S. royalties will revert back to GSK. Royalty fees earned by GSK and 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 GSK and Royalty Pharma were $58.2 million, $46.6 million and $32.7 million during the years ended December 31, 2022, 2021 and 2020, respectively. Other Collaborations Genentech Collaboration We have out-licensed to Genentech under a worldwide collaboration agreement, the development and commercialization of cobimetinib, under the brand name COTELLIC. The terms of the collaboration agreement require that we share in the profits and losses received or incurred in connection with the commercialization of COTELLIC in the U.S. In addition to our profit share in the U.S., we are entitled to low double-digit royalties on net sales of COTELLIC outside the U.S. During the years ended December 31, 2022, 2021 and 2020, we recognized $12.5 million, $12.1 million, and $11.3 million, in revenues from profits and losses on U.S commercialization and royalties on ex-U.S. sales under the collaboration agreement with Genentech and are included within license revenues on our Consolidated Statements of Income. Research Collaborations, In-Licensing Arrangements and Other Business Development Activities We entered into collaborative arrangements with other pharmaceutical or biotechnology companies to develop and commercialize drug candidates or 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 include upfront payments, development, regulatory, commercial milestone payments and royalty payments, 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 or acquire the intellectual property 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 clinical development, manufacturing and commercialization. In June 2022, we entered into an exclusive option and license agreement with BioInvent International AB (BioInvent), upon which we paid an upfront payment of $25.0 million. If we decide to exercise the option, we will pay BioInvent an option exercise fee, and BioInvent would be eligible for additional payments from us for future development and commercial milestones, as well as royalties on future net sales of products. In November 2022, we entered into an agreement with Cybrexa Therapeutics, LLC (Cybrexa), which provides us the right to acquire CBX-12 (alphalex™ exatecan), a clinical-stage peptide-drug conjugate that utilizes Cybrexa’s proprietary alphalex technology to enhance delivery of exatecan to tumor cells. Under the terms of the agreement, we made an upfront payment of $60.0 million for a warrant entitling us to the right to acquire the Cybrexa affiliate that controls CBX-12 and related assets, and to fund certain development and manufacturing expenses incurred by Cybrexa to advance CBX-12 during the warrant period. Cybrexa will continue the development of CBX-12 according to an agreed development plan, including phase 1 studies, and may be eligible to receive up to $65.0 million in additional development milestone payments, during the warrant period. We may exercise the warrant for up to $300.0 million based upon our evaluation of a pre-specified clinical data package to be delivered by Cybrexa. Following exercise of the warrant, Cybrexa would be eligible to receive up to $277.5 million in additional payments upon achievement of further regulatory and commercial milestones. We have determined our arrangement with Cybrexa constitutes a variable interest in the Cybrexa affiliate that controls CBX-12 and related assets, and that the Cybrexa affiliate is a VIE; however, we are not the primary beneficiary of the Cybrexa affiliate as we do not control the activities that are most significant to the Cybrexa affiliate. We have accounted for our arrangement with Cybrexa as an acquisition of in-process research and development technology that does not have an alternative future use, and accordingly, recognized the upfront payment of $60.0 million in research and development expenses during the year-ended December 31, 2022. In November 2022, we entered into an exclusive option and license agreement with Sairopa, B.V. (Sairopa). Under the terms of the agreement, we made an upfront payment of $40.0 million for an option to obtain an exclusive, worldwide license to develop and commercialize ADU-1805 and other anti-SIRPα antibodies. Sairopa is eligible to receive additional development milestone payments during the option period totaling up to $97.5 million. Following the completion of the clinical studies, we may exercise the option for $225.0 million based upon our evaluation of a pre-specified clinical data package to be delivered by Sairopa. Following the exercise of the option, Sairopa would be eligible to receive up to $465.0 million in additional payments upon achievement of further development and commercial milestones, as well as royalties on future net sales of products. In November 2022, we entered into a new license agreement with Catalent, Inc.’s wholly owned subsidiaries Redwood Bioscience, Inc., R.P. Scherer Technologies, LLC and Catalent Pharma Solutions, Inc., (individually and collectively referred to |
Cash and Investments
Cash and Investments | 12 Months Ended |
Dec. 30, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
CASH AND INVESTMENTS | CASH AND INVESTMENTS Cash, Cash Equivalents and Restricted Cash Equivalents A reconciliation of cash, cash equivalents, and restricted cash equivalents reported in the accompanying Consolidated Balance Sheets to the amount reported within the accompanying Consolidated Statements of Cash Flows was as follows (in thousands): December 31, 2022 2021 Cash and cash equivalents $ 501,195 $ 647,169 Restricted cash equivalents included in other long-term assets 1,482 16,722 Cash, cash equivalents and restricted cash equivalents as reported within the accompanying Consolidated Statements of Cash Flows $ 502,677 $ 663,891 Restricted cash equivalents are used to collateralize letters of credit agreements and are invested in short-term certificates of deposit with original maturity of 90 days or less as of December 31, 2022 and money market fund securities as of December 31, 2021. The restricted cash equivalents are classified as other long-term assets. The standby letter of credit entered into in January 2021, as a guarantee of our obligation to fund our portion of the tenant improvements related to our Alameda build-to-suit lease was extinguished and the related collateral was returned in the third quarter of 2022, following the substantial completion of the building and the commencement of the lease. Cash, Cash Equivalents, Restricted Cash Equivalents and Investments Cash, cash equivalents, restricted cash equivalents and investments consisted of the following (in thousands): December 31, 2022 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Debt securities available-for-sale: Commercial paper $ 722,018 $ — $ — $ 722,018 Corporate bonds 810,439 541 (13,132) 797,848 U.S. Treasury and government-sponsored enterprises 338,218 48 (5,679) 332,587 Municipal bonds 16,385 — (223) 16,162 Total debt securities available-for-sale 1,887,060 589 (19,034) 1,868,615 Cash 41 — — 41 Money market funds 94,344 — — 94,344 Certificates of deposit 103,681 — — 103,681 Total cash, cash equivalents, restricted cash equivalents and investments $ 2,085,126 $ 589 $ (19,034) $ 2,066,681 December 31, 2021 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Debt securities available-for-sale: Commercial paper $ 945,801 $ 42 $ (2) $ 945,841 Corporate bonds 541,774 876 (1,672) 540,978 U.S. Treasury and government-sponsored enterprises 33,965 1 (21) 33,945 Municipal bonds 12,924 15 (35) 12,904 Total debt securities available-for-sale 1,534,464 934 (1,730) 1,533,668 Cash 135,653 — — 135,653 Money market funds 66,531 — — 66,531 Certificates of deposit 119,056 — — 119,056 Total cash, cash equivalents, restricted cash equivalents and investments $ 1,855,704 $ 934 $ (1,730) $ 1,854,908 Interest receivable was $7.3 million and $2.9 million as of December 31, 2022 and 2021, respectively, and is included in prepaid and other current assets in the accompanying Consolidated Balance Sheets. Realized gains and losses on the sales of investments were insignificant during the years ended December 31, 2022, 2021 and 2020. We manage credit risk associated with our investment portfolio through our investment policy, which limits purchases to high-quality issuers and limits the amount of our portfolio that can be invested in a single issuer. The fair value and gross unrealized losses on debt securities available-for-sale in an unrealized loss position were as follows (in thousands): December 31, 2022 Fair Value Gross Unrealized Losses Corporate bonds $ 706,711 $ (13,132) U.S. Treasury and government-sponsored enterprises 308,307 (5,679) Municipal bonds 15,792 (223) Total $ 1,030,810 $ (19,034) December 31, 2021 Fair Value Gross Unrealized Losses Corporate bonds $ 385,053 $ (1,672) Commercial paper 43,290 (2) U.S. Treasury and government-sponsored enterprises 18,962 (21) Municipal bonds 7,475 (35) Total $ 454,780 $ (1,730) There were 285 and 133 debt securities available-for-sale in an unrealized loss position as of December 31, 2022 and 2021, respectively. All securities presented above have been in an unrealized loss position for less than twelve months except for 76 corporate bond securities, 4 municipal bond securities and 1 U.S. Treasury and government-sponsored enterprises security with an aggregate fair value of $237.6 million and an aggregate $6.1 million unrealized losses as of December 31, 2022. During the years ended December 31, 2022 and 2021, we did not record an allowance for credit losses or other impairment charges on our investment securities. Based upon our quarterly impairment review, we determined that the unrealized losses were not attributed to credit risk, but were primarily associated with changes in interest rates and market liquidity. Based on the scheduled maturities of our investments, we determined that it was more likely than not that we will hold these investments for a period of time sufficient for a recovery of our cost basis. The fair value of debt securities available-for-sale by contractual maturity was as follows (in thousands): December 31, 2022 2021 Maturing in one year or less $ 1,114,884 $ 1,168,256 Maturing after one year through five years 753,731 365,412 Total debt securities available-for-sale $ 1,868,615 $ 1,533,668 |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
FAIR VALUE MEASUREMENTS | FAIR VALUE MEASUREMENTS Fair value reflects the amounts that would be received upon sale of an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. The fair value hierarchy has the following three levels: • Level 1 - quoted prices (unadjusted) in active markets for identical assets and liabilities; • Level 2 - inputs other than level 1 that are observable either directly or indirectly, such as quoted prices in active markets for similar instruments or on industry models using data inputs, such as interest rates and prices that can be directly observed or corroborated in active markets; and • Level 3 - unobservable inputs that are supported by little or no market activity that are significant to the fair value measurement. The classifications within the fair value hierarchy of our financial assets that were measured and recorded at fair value on a recurring basis were as follows (in thousands): December 31, 2022 Level 1 Level 2 Total Commercial paper $ — $ 722,018 $ 722,018 Corporate bonds — 797,848 797,848 U.S. Treasury and government-sponsored enterprises — 332,587 332,587 Municipal bonds — 16,162 16,162 Total debt securities available-for-sale — 1,868,615 1,868,615 Money market funds 94,344 — 94,344 Certificates of deposit — 103,681 103,681 Total financial assets carried at fair value $ 94,344 $ 1,972,296 $ 2,066,640 December 31, 2021 Level 1 Level 2 Total Commercial paper $ — $ 945,841 $ 945,841 Corporate bonds — 540,978 540,978 U.S. Treasury and government-sponsored enterprises — 33,945 33,945 Municipal bonds — 12,904 12,904 Total debt securities available-for-sale — 1,533,668 1,533,668 Money market funds 66,531 — 66,531 Certificates of deposit — 119,056 119,056 Total financial assets carried at fair value $ 66,531 $ 1,652,724 $ 1,719,255 When available, we value investments based on quoted prices for those financial instruments, which is a Level 1 input. Our remaining investments are valued using third-party pricing sources, which use observable market prices, interest rates and yield curves observable at commonly quoted intervals for similar assets as observable inputs for pricing, which is a Level 2 input. The carrying amount of our remaining financial assets and liabilities, which include cash, receivables and payables, approximate their fair values due to their short-term nature. Forward Foreign Currency Contracts In January 2021, we initiated an operational hedging program and entered into forward contracts 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 December 31, 2022, 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 prepaid expenses and other current assets in the Consolidated Balance Sheets. The unrealized loss on the forward contract is not material as of December 31, 2022. The forward contract is considered a Level 2 in the fair value hierarchy of our fair value measurements. For the years ended December 31, 2022 and 2021 we recognized $1.2 million and $0.8 million of net gains on the maturity of forward contracts, which were included in other income (expense), net on our Consolidated Statements of Income. |
Inventory
Inventory | 12 Months Ended |
Dec. 30, 2022 | |
Inventory Disclosure [Abstract] | |
INVENTORY | INVENTORY Inventory consisted of the following (in thousands): December 31, 2022 2021 Raw materials $ 8,077 $ 8,867 Work in process 43,564 27,717 Finished goods 10,635 12,927 Total $ 62,276 $ 49,511 Balance Sheet classification: Current portion included in inventory $ 33,299 $ 27,493 Long-term portion included in other long-term assets 28,977 22,018 Total $ 62,276 $ 49,511 |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 30, 2022 | |
Property, Plant and Equipment [Abstract] | |
PROPERTY AND EQUIPMENT | PROPERTY AND EQUIPMENT Property and equipment consisted of the following (in thousands): Estimated Useful Lives December 31, 2022 2021 Leasehold improvements up to 15 years $ 83,334 $ 73,589 Computer equipment and software up to 3 years 19,569 14,877 Furniture and fixtures 7 years 24,054 15,780 Laboratory equipment 5 years 39,606 23,744 Construction in progress 4,933 16,872 Total property and equipment 171,496 144,862 Less: accumulated depreciation (60,872) (40,831) Total property and equipment, net $ 110,624 $ 104,031 Depreciation expense was $20.9 million, $13.6 million and $9.1 million during the years ended December 31, 2022, 2021 and 2020, respectively. |
Employee Benefit Plans
Employee Benefit Plans | 12 Months Ended |
Dec. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
EMPLOYEE BENEFIT PLANS | EMPLOYEE BENEFIT PLANS Equity Incentive Plans and ESPP We allocated the stock-based compensation expense for our equity incentive plans and our ESPP as follows (in thousands): Year Ended December 31, 2022 2021 2020 Research and development $ 45,350 $ 46,654 $ 37,198 Selling, general and administrative 62,224 73,166 67,872 Total stock-based compensation expense $ 107,574 $ 119,820 $ 105,070 Year Ended December 31, 2022 2021 2020 Stock options $ 12,790 $ 19,048 $ 19,863 Restricted stock units 69,775 53,629 35,675 Performance stock units 21,616 43,428 47,106 ESPP 3,393 3,715 2,426 Total stock-based compensation expense $ 107,574 $ 119,820 $ 105,070 We have several equity incentive plans under which we granted stock options and RSUs, including PSUs, to employees and directors. On May 25, 2022, at the 2022 Annual Meeting of Stockholders, our stockholders approved the amendment and restatement of Exelixis, Inc. 2017 Equity Incentive Plan (as amended and restated, the 2017 Plan). The amendment and restatement increased the share reserve under the 2017 Plan by 28,500,000 shares. As of December 31, 2022, 31,971,047 shares were available for grant under the 2017 Plan. The share reserve is reduced by 1 share for each share issued pursuant to a stock option and 2 shares for full value awards, including RSUs. The Board of Directors delegated responsibility for administration of our equity incentive plans to the Compensation Committee of our Board of Directors, including the authority to determine the term, exercise price and vesting requirements of each grant. Stock options granted to our employees and directors generally have a four-year vesting term and a one-year vesting term, respectively, an exercise price equal to the fair market value on the date of grant, and a seven-year life from the date of grant. RSUs granted to our employees and directors generally have a four-year vesting term and a one-year vesting term, respectively. PSUs granted pursuant to our equity incentive plans vest upon specified service conditions and the achievement of a performance target or market condition. We have adopted a Change in Control and Severance Benefit Plan for certain executive officers. Eligible Change in Control and Severance Benefit Plan participants include employees with the title of vice president and above. If a participant’s employment is terminated without cause during a period commencing one month before and ending thirteen months following a change in control, as defined in the plan document, then the Change in Control and Severance Benefit Plan participant is entitled to have the vesting of all their outstanding equity awards accelerated and the exercise period for their stock options extended to no more than one year. We have an ESPP that allows for qualified employees (as defined in the ESPP) to purchase shares of our common stock at a price equal to the lower of 85% of the closing price at the beginning of the offering period or 85% of the closing price at the end of each six-month purchase period. As of December 31, 2022, we had 2,561,567 shares available for issuance under our ESPP. Pursuant to the ESPP, we issued 606,787, 536,226 and 534,419 shares of common stock at an average price per share of $16.63, $17.76 and $14.55 during the years ended December 31, 2022, 2021 and 2020, respectively. Cash received from purchases under the ESPP for the years ended December 31, 2022, 2021 and 2020 was $10.1 million, $9.5 million and $7.8 million, respectively. We used a Black-Scholes Merton option pricing model to value stock options and ESPP purchases. The weighted average grant-date fair value per share of stock options and ESPP purchases were as follows: Year Ended December 31, 2022 2021 2020 Stock options $ 8.36 $ 9.04 $ 9.44 ESPP $ 5.80 $ 6.12 $ 6.12 The grant-date fair value of stock option grants and ESPP purchases was estimated using the following assumptions: Year Ended December 31, 2022 2021 2020 Stock options: Risk-free interest rate 2.35 % 0.74 % 0.30 % Dividend yield — % — % — % Volatility 48 % 51 % 54 % Expected life 4.6 years 4.6 years 4.4 years ESPP: Risk-free interest rate 1.49 % 0.08 % 0.79 % Dividend yield — % — % — % Volatility 45 % 47 % 52 % Expected life 6 months 6 months 6 months We considered both implied and historical volatility in developing our estimate of expected volatility. The assumption for the expected life of stock options is based on historical exercise patterns and post-vesting termination behavior. The risk-free interest rate is based on U.S. Treasury rates with the same or similar term as the underlying award. Our dividend rate is based on historical experience and our investors’ current expectations. The fair value of RSUs, including PSUs, was based on the closing price of the underlying common stock on the date of grant. Activity for stock options during the year ended December 31, 2022 was as follows (in thousands , except per share amounts): Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term Aggregate Intrinsic Value Stock options outstanding at December 31, 2021 13,671 $ 16.79 Granted 589 $ 19.99 Exercised (2,743) $ 5.74 Cancelled (635) $ 21.29 Stock options outstanding at December 31, 2022 10,882 $ 19.49 3.0 years $ 9,377 Stock options exercisable at December 31, 2022 8,743 $ 19.17 2.4 years $ 9,373 As of December 31, 2022, there was $16.6 million of unrecognized compensation expense related to our unvested stock options. The compensation expense for the unvested stock options will be recognized over a weighted-average period of 2.2 years. The aggregate intrinsic value in the table above represents the total intrinsic value (the difference between our closing stock price on the last trading day of fiscal year 2022 and the exercise prices, multiplied by the number of in-the-money stock options) that would have been received by the stock option holders had all stock option holders exercised their stock options on December 31, 2022. The total intrinsic value of stock options exercised during the years ended December 31, 2022, 2021 and 2020 was $36.5 million, $76.0 million and $106.5 million, respectively. Cash received from stock option exercises during the years ended December 31, 2022, 2021 and 2020 was $13.9 million, $14.8 million and $26.9 million, respectively. Activity for RSUs during the year ended December 31, 2022 was as follows (in thousands, except per share amounts): Shares Weighted Average Grant Date Fair Value Weighted Average Remaining Contractual Term Aggregate Intrinsic Value RSUs outstanding at December 31, 2021 6,828 $ 21.58 Awarded 7,933 $ 21.84 Vested and released (2,164) $ 21.31 Forfeited (1,303) $ 21.43 RSUs outstanding at December 31, 2022 11,294 $ 21.83 1.8 years $ 181,156 As of December 31, 2022, there was $183.6 million of unrecognized compensation expense related to our unvested RSUs which will be recognized over a weighted-average period of 2.9 years. Activity for PSUs, during the year ended December 31, 2022 was as follows (in thousands , except per share amounts): Shares Weighted Average Grant Date Fair Value Weighted Average Remaining Contractual Term Aggregate Intrinsic Value PSUs outstanding at December 31, 2021 6,310 $ 23.00 Awarded — $ — Vested and released (942) $ 21.32 Forfeited (404) $ 24.56 PSUs outstanding at December 31, 2022 4,964 $ 23.26 2.3 years $ 79,628 In March 2022, in connection with our long-term incentive compensation program, we awarded to certain employees an aggregate of 1,003,482 (the 2022 target amount) RSUs that are subject to a total shareholder return (TSR) market condition (the 2022 TSR-based RSUs). The TSR market condition for the 2022 TSR-based RSUs is based on our relative TSR percentile rank compared to companies in the NASDAQ Biotechnology Index during the performance period, which is January 1, 2022 through January 3, 2025. Depending on the results relative to the TSR market condition, the holders of the 2022 TSR-based RSUs may earn up to 175% of the 2022 target amount of shares. 50% of the shares earned pursuant to the 2022 TSR-based RSU awards will vest at the end of the performance period, and the remainder will vest approximately one year later, subject to employee’s continuous service. These TSR-based RSUs will be forfeited if the market condition at or above a threshold level is not achieved at the end of the performance period on January 3, 2025. We used a Monte Carlo simulation model and the following assumptions to determine the grant date fair value of $33.17 per share for the 2022 TSR-based RSUs: Fair value of Exelixis common stock on grant date $ 20.70 Expected volatility 46.85 % Risk-free interest rate 1.59 % Dividend yield — % The Monte Carlo simulation model also assumed correlations of returns of the stock prices of 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 total stockholder return based on the provisions of the award. In March 2021, in connection with our long-term incentive compensation program, we awarded certain employees 1,027,650 (the 2021 target amount) PSUs, subject to a performance and a market condition (the 2021 PSUs). Pursuant to the terms of 2021 PSUs, the holders of the awards may earn up to 200% of the 2021 target amount, or up to 2,055,300 total shares, depending on the level of achievement of the performance condition related to certain net product revenues and a TSR market condition. The TSR market condition for the 2021 PSUs is based on our relative TSR percentile rank compared to companies in the Nasdaq Biotechnology Index during the performance period, which is January 2, 2021 through December 29, 2023. 50% percent of the shares earned subject to the performance and market conditions 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. The 2021 PSUs will be forfeited if the performance condition at or above a threshold level is not achieved by December 29, 2023. The performance condition for target achievement of net product revenues relative to the 2021 PSUs was deemed probable of achievement in the fourth quarter of 2022 representing 100% of the 2021 PSUs target amount. A Monte Carlo simulation model was used to determine the grant date fair value of $24.54 for the 2021 PSUs based on the following assumptions: Fair value of Exelixis common stock on grant date $ 21.31 Expected volatility 49.21 % Risk-free interest rate 0.29 % Dividend yield — % During the year ended December 31, 2020, in connection with our long-term incentive compensation program, we awarded 2,327,840 PSUs (the 2020 target amount) that will vest upon the achievement of performance targets related to (i) clinical trial positive top-line results and (ii) product approvals by the FDA (the 2020 PSUs). Pursuant to the terms of the 2020 PSUs, employees may earn up to 200% of the 2020 target amount, or 4,655,680 total shares, depending on the volume and timing of achievement of the performance targets. The 2020 PSUs will be forfeited if the performance targets are not met by December 31, 2024. The performance condition for threshold achievement of a product approval by the FDA relative to the 2020 PSUs occurred in the third quarter of 2021, representing 25% of the 2020 target amount. The performance condition for threshold achievement of positive top-line results by the FDA relative to the 2020 PSUs occurred in the third quarter of 2022, representing 25% of the 2020 target amount. Expense recognition for PSUs commences when it is determined that attainment of the performance target is probable. Of the outstanding PSUs as of December 31, 2022, 869,502 relate to awards for which we achieved the performance target. As of December 31, 2022, the remaining unrecognized compensation expense for the PSUs achieved or deemed probable of achievement related to the PSUs was $11.0 million, which will be recognized over a weighted-average period of 2.3 years. The total unrecognized compensation expense for the PSUs for which we have not yet determined that attainment of the performance target is probable was $79.5 million as of December 31, 2022. Exelixis, Inc. 401(k) Plan (the 401(k) Plan) |
Provision For Income Taxes
Provision For Income Taxes | 12 Months Ended |
Dec. 30, 2022 | |
Income Tax Disclosure [Abstract] | |
PROVISION FOR INCOME TAXES | PROVISION FOR INCOME TAXES Our income before income taxes is derived solely from within the U.S. Our provision for income taxes was as follows (in thousands): Year Ended December 31, 2022 2021 2020 Current: Federal $ 100,525 $ 11,338 $ — State 11,903 5,224 3,791 Total current tax expense $ 112,428 $ 16,562 $ 3,791 Deferred: Federal $ (54,223) $ 46,416 $ 14,886 State (6,135) 113 379 Total deferred tax expense (60,358) 46,529 15,265 Provision for income taxes $ 52,070 $ 63,091 $ 19,056 The provision for income taxes for the years ended December 31, 2022, 2021, and 2020 primarily relates to the utilization of federal tax attributes and state taxes in jurisdictions outside of California, for which we do not have net operating loss carryforwards due to a limited operating history. Our historical net operating losses were sufficient to fully offset any federal taxable income for the year ended December 31, 2020 but were not sufficient to fully offset federal taxable income for the years ended December 31, 2022 and 2021. The reconciliation of the U.S. federal income tax provision at the statutory federal income tax rate of 21% for each of the years ended December 31, 2022, 2021 and 2020, respectively, to our provision for income taxes was as follows (in thousands): Year Ended December 31, 2022 2021 2020 U.S. federal income tax provision at statutory rate $ 49,213 $ 61,772 $ 27,476 State tax (benefit) expense (2,632) 1,336 (2,232) Change in valuation allowance 7,162 2,883 5,525 Research credits (14,130) (6,263) (11,356) Stock-based compensation (2,864) (11,831) (20,399) Non-deductible executive compensation 4,549 11,182 18,067 Branded prescription drug fee 3,855 2,897 2,537 Non-deductible warrant purchase 6,300 — — Other 617 1,115 (562) Provision for income taxes $ 52,070 $ 63,091 $ 19,056 Deferred tax assets and liabilities reflect the net tax effects of net operating loss and tax credit carryforwards and temporary differences between the carrying amounts of assets and liabilities for financial reporting and the amounts used for income tax purposes. Our deferred tax assets and liabilities were as follows (in thousands): December 31, 2022 2021 Deferred tax assets: Net operating loss carryforwards $ 33,635 $ 17,993 Tax credit carryforwards 40,217 101,460 Depreciation and amortization 176,208 7,764 Stock-based compensation 27,531 23,162 Lease liabilities 46,759 12,385 Accruals and reserves not currently deductible 22,418 19,531 Deferred revenue 7,656 8,040 Other assets 6,746 1,303 Total deferred tax assets 361,170 191,638 Valuation allowance (77,230) (70,068) Net deferred tax assets 283,940 121,570 Deferred tax liabilities: Lease right-of-use assets (52,830) (9,907) Net deferred taxes $ 231,110 $ 111,663 ASC Topic 740: Income Taxes (Topic 740) requires that the tax benefit of net operating losses, temporary differences and credit carry forwards be recorded as an asset to the extent that management assesses that realization is “more likely than not.” Realization of the future tax benefits is dependent on our ability to generate sufficient taxable income within the carry forward period. As of each reporting date, management considers new evidence, both positive and negative, that could affect its view of the future realization of deferred tax assets. As of December 31, 2022, based on the evaluation and weighting of both positive and negative evidence, including our achievement of a cumulative three-year income position as of December 31, 2022 and forecasts of future operating results, as well as considering the utilization of net operating losses and tax credits prior to their expiration, management has continued to determine that there is sufficient positive evidence to conclude that it is more likely than not the deferred tax assets are realizable. As of December 31, 2022 and 2021, we continue to carry a valuation allowance of $77.2 million and $70.1 million, respectively, against our California state deferred tax assets. The valuation allowance increased by $7.2 million and $2.9 million during the years ended December 31, 2022 and 2021, respectively. At December 31, 2022, we had state net operating loss carryforwards of approximately $414 million, which expire in the years 2023 through 2036, California research and development tax credits of approximately $52 million, which do not expire, and California Competes Tax Credits of approximately $1 million, which begin to expire in 2028. Under the Internal Revenue Code and similar state provisions, certain substantial changes in our ownership could result in an annual limitation on the amount of net operating loss and credit carryforwards that can be utilized in future years to offset future taxable income. The annual limitation may result in the expiration of net operating losses and credit carryforwards before utilization. We completed a Section 382 analysis through December 31, 2022, and concluded that an ownership change, as defined under Section 382, had not occurred. The following table summarizes the activity related to our unrecognized tax benefits (in thousands): Year Ended December 31, 2022 2021 2020 Beginning balance $ 83,583 $ 80,941 $ 79,078 Change relating to prior year provision 715 728 591 Change relating to current year provision 4,129 2,215 3,305 Reductions based on the lapse of the applicable statutes of limitations (721) (301) (2,033) Ending balance $ 87,706 $ 83,583 $ 80,941 We classify unrecognized tax benefits as a reduction of deferred tax assets or as other long-term liabilities in the accompanying consolidated balance sheets. We do not anticipate that the amount of unrecognized tax benefits existing as of December 31, 2022 will significantly change over the next 12 months. As of December 31, 2022, we had $87.7 million in unrecognized tax benefits, of which $55.4 million would reduce our income tax provision and effective tax rate, if recognized. Interest and penalties were nominal or zero for all periods presented. We have elected to record interest and penalties in the accompanying Consolidated Statements of Income as a component of income taxes. We file U.S. and state income tax returns in jurisdictions with varying statues of limitations during which such tax returns may be audited and adjusted by the relevant tax authorities. The 2001 through 2022 tax years generally remain subject to examination by federal and most state tax authorities to the extent net operating losses and credits generated during these periods are being utilized in the open tax periods. |
Net Income Per Share
Net Income Per Share | 12 Months Ended |
Dec. 30, 2022 | |
Earnings Per Share [Abstract] | |
NET INCOME PER SHARE | NET INCOME PER SHARE Net income per share - basic and diluted, were computed as follows (in thousands, except per share amounts): Year Ended December 31, 2022 2021 2020 Numerator: Net income $ 182,282 $ 231,063 $ 111,781 Denominator: Weighted-average common shares outstanding - basic 321,526 314,884 308,271 Dilutive securities 3,030 7,475 9,730 Weighted-average common shares outstanding - diluted 324,556 322,359 318,001 Net income per share - basic $ 0.57 $ 0.73 $ 0.36 Net income per share - diluted $ 0.56 $ 0.72 $ 0.35 Dilutive securities included outstanding stock options, unvested RSUs, unvested RSUs with market conditions, PSUs and ESPP contributions. Certain potential common shares were excluded from our calculation of weighted-average common shares outstanding - diluted because either they would have had an anti-dilutive effect on net income per share or they were related to shares from PSUs that were contingently issuable and the contingency had not been satisfied at the end of the reporting period. See “Note 8. Employee Benefit Plans” for a further description of our equity awards. The weighted-average potential common shares excluded from our calculation were as follows (in thousands): Year Ended December 31, 2022 2021 2020 Anti-dilutive securities and contingently issuable shares excluded 17,063 14,305 10,959 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | COMMITMENTS AND CONTINGENCIES Leases We have noncancellable operating leases of corporate headquarters, office and laboratory space in California and Pennsylvania totaling 673,978 square feet with lease terms ending in 2024 through 2037. Certain of our leases include options to renew the lease or to early terminate the lease. As of December 31, 2022, it is not probable we will exercise our options to renew these leases, nor is it probable that we will not exercise our option to terminate certain of our leases before the end of the lease term. As of December 31, 2022, we have lease agreements for laboratory spaces located in Pennsylvania totaling 28,228 square feet for which the leases of the premises have not commenced. We expect these leases to commence upon substantial completion of leasehold improvements by the lessor and upon receiving access to those premises. The balance sheet classification of our operating lease assets and liabilities were as follows (in thousands): December 31, 2022 2021 Assets: Right-of-use assets included in other long-term assets $ 234,811 $ 45,122 Liabilities: Current portion included in other current liabilities $ 17,659 $ 5,137 Long-term portion of operating lease liabilities 190,170 51,272 Total operating lease liabilities $ 207,829 $ 56,409 The components of operating lease costs were as follows (in thousands): Year Ended December 31, 2022 2021 2019 Operating lease cost $ 18,315 $ 5,332 $ 4,825 Variable lease cost 3,098 2,685 2,830 Total operating lease costs $ 21,413 $ 8,017 $ 7,655 Cash paid for amounts included in the measurement of lease liabilities for the years ended December 31, 2022, 2021 and 2020 was $11.4 million, $5.0 million and $4.6 million, respectively, and was included in net cash provided by operating activities in our Consolidated Statements of Cash Flows. As of December 31, 2022, the maturities of our operating lease liabilities were as follows (in thousands): Year Ended December 31, Amount 2023 $ 18,057 2024 23,682 2025 23,111 2026 23,608 2027 24,313 Thereafter 206,605 Total lease payments 319,376 Less: Imputed interest (88,310) Future tenant improvement reimbursements (23,237) Operating lease liabilities $ 207,829 As of December 31, 2022, the weighted average discount rate used to determine the operating lease liability was 5.3% and the weighted average remaining lease term was 12.7 years. Lease cost for leases with initial terms less than 1 year for the year ended December 31, 2022 was $0.4 million, and immaterial for the years ended December 31, 2021 and 2020. 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. This ruling in MSN I does not impact our separate and ongoing MSN II lawsuit. 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 remedies, equitable relief enjoining MSN from infringing the asserted patents, as well as an order that the effective date of any FDA approval of MSN’s ANDA would be a date no earlier than the expiration of all of U.S. Patents No. 11,091,439, 11,091,440, 11,098,015 and 11,298,349, the latest of which expires on February 10, 2032. A bench trial for MSN II has been scheduled for October 2023. Teva ANDA Litigation In May 2021, we received notice letters from Teva Pharmaceutical Industries Limited, Teva Pharmaceuticals Development, Inc. and Teva Pharmaceuticals USA, Inc. (individually and collectively referred to as Teva) regarding an ANDA Teva submitted to the FDA, requesting approval to market a generic version of CABOMETYX tablets. Teva’s notice letters included a Paragraph IV certification with respect to our U.S. Patents No. 9,724,342 (formulations), 10,034,873 (methods of treatment) and 10,039,757 (methods of treatment), which are listed in the Orange Book. Teva’s notice letters did not provide a Paragraph IV certification against any additional CABOMETYX patents. On June 17, 2021, we filed a complaint in the Delaware District Court for patent infringement against Teva asserting infringement of U.S. Patents No. 9,724,342, 10,034,873 and 10,039,757 arising from Teva’s ANDA filing with the FDA. On August 27, 2021, Teva filed its answer and counterclaims to the complaint, alleging that the asserted claims of U.S. Patents No. 9,724,342, 10,034,873 and 10,039,757 are invalid and not infringed. On September 17, 2021, we filed an answer to Teva’s counterclaims. On July 29, 2022, we received notice from Teva that it had amended its ANDA to assert an additional Paragraph IV certification. As amended, Teva’s ANDA now requests approval to market a generic version of CABOMETYX tablets prior to expiration of a previously-unasserted CABOMETYX patent that is now listed in the Orange Book: U.S. Patent No. 11,298,349 (pharmaceutical composition). On September 2, 2022, we filed a complaint in the Delaware District Court for patent infringement against Teva, asserting infringement of U.S. Patent No. 11,298,349 arising from Teva’s amended ANDA filing with the FDA. We are seeking, among other relief, an order that the effective date of any FDA approval of Teva’s ANDA be a date no earlier than the expiration of all of U.S. Patents No. 9,724,342, 10,034,873, 10,039,757 and 11,298,349, the latest of which expires on July 9, 2033, and equitable relief enjoining Teva from infringing these patents. On September 30, 2022, the parties filed a stipulation to consolidate the two lawsuits, numbered Civil Action Nos. 21-00871 and 22-01168, and to stay all proceedings, which was granted by the Delaware District Court on October 3, 2022. Following a similar order granted by the Delaware District Court on February 9, 2022 to stay all proceedings with respect to Civil Action No. 21-00871, this case remained administratively closed, and Civil Action No. 22-01168 was administratively closed on October 3, 2022. Other On February 6, 2023, we received a notice letter regarding an ANDA submitted to the FDA by Cipla Limited (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), 11,098,015 (methods of treatment), 11,091,439 (crystalline salt forms), 11,091,440 (pharmaceutical composition) and 11,298,349 (pharmaceutical composition). Cipla’s ANDA requests approval to market a generic version of CABOMETYX tablets prior to the expiration of the aforementioned patents. We have not yet responded to this Paragraph IV certification notice letter but are evaluating it. 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. |
Organization and Summary of S_2
Organization and Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Basis of Presentation | The accompanying 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 made reclassifications to our prior years’ Consolidated Financial Statements to conform to the current year’s presentation. These reclassifications did not impact previously reported total revenues, income from operations, net income, total assets, total liabilities, total operating, investing or financing cash flows or total stockholders’ equity. |
Segment Information | We operate in one business segment that focuses on the discovery, development and commercialization of new medicines for difficult-to-treat cancers. Our Chief Executive Officer, as the chief operating decision-maker, manages and allocates resources to our operations on a total consolidated basis. Consistent with this decision-making process, our Chief Executive Officer uses consolidated, single-segment financial information for purposes of evaluating performance, forecasting future period financial results, allocating resources and setting incentive targets. |
Use of Estimates | The preparation of the accompanying 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. |
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 Annual Report on Form 10-K for the year ended December 31, 2021, which could have a significant effect on our Consolidated Financial Statements. Recent Accounting Pronouncements Not Yet Adopted There were no new accounting pronouncements issued since our filing of the Annual Report on Form 10-K for the year ended December 31, 2021, which could have a significant effect on our Consolidated Financial Statements. |
Cash and Cash Equivalents | We consider all highly liquid investments purchased with an original maturity of three months or less to be cash equivalents. Cash equivalents include high-grade, short-term investments in money market funds, certificates of deposit and marketable debt securities which are subject to minimal credit and market risk. |
Investments and Investment Impairment | We designate all investments in marketable debt securities as available-for-sale and therefore, report such investments at fair value, with unrealized gains and losses recorded in accumulated other comprehensive income. For securities sold prior to maturity, the cost of securities sold is based on the specific identification method. We include realized gains and losses on the sale of investments in other income, net in the accompanying Consolidated Statements of Income. We classify those investments that we do not require for use in current operations and that mature in more than 12 months as long-term investments in the accompanying Consolidated Balance Sheets. The classification of restricted cash equivalents as short-term or long-term is dependent upon the longer of the remaining term to maturity of the investment or the remaining term of the related restriction. Investment Impairment Quarterly, we assess each of our investments in available-for-sale debt securities whose fair value is below its cost basis to determine if the investment’s impairment is due to credit-related factors or noncredit-related factors. Factors considered in determining whether an impairment is credit-related include the extent to which the investment’s fair value is less than its cost basis, declines in published credit ratings, issuer default on interest or principal payments, and declines in the financial condition and near-term prospects of the issuer. If we determine a credit-related impairment exists, we will measure the credit loss based on a discounted cash flows model. Credit-related impairments on available-for-sale debt securities are recognized as an allowance for credit losses with a corresponding adjustment to other income, net in the accompanying Consolidated Statements of Income. The portion of the impairment that is not credit-related is recorded as a reduction of other comprehensive income (loss), net of applicable taxes. We have elected to exclude accrued interest from both the fair value and the amortized cost basis of the available-for-sale debt securities for the purposes of identifying and measuring an impairment. We write-off accrued interest as a reduction of interest income when an issuer has defaulted on interest payments due on a security. |
Fair Value Measurements | We define fair value as the amounts that would be received upon sale of an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date (exit price). When determining the fair value measurements for assets and liabilities which are required to be recorded at fair value, we consider the principal or most advantageous market in which we would transact and the market-based risk measurements or assumptions that market participants would use in pricing the asset or liability, such as risks inherent in valuation techniques, transfer restrictions and credit risks. |
Foreign Currency Remeasurement | Monetary assets and liabilities denominated in currencies other than the functional currency are remeasured using exchange rates in effect at the end of the period and related gains or losses are recorded in other income, net in the accompanying Consolidated Statements of Income. |
Accounts Receivable | Trade receivables, net, contain amounts billed to our customers for product sales, and amounts billed to our collaboration partners for development, regulatory and sales-based milestone payments, royalties on the sale of licensed products, profit-sharing arrangements, development cost reimbursements, and payments for product supply services. Our customers are primarily pharmaceutical and biotechnology companies that are located in the U.S., and collaboration partners that are located in Europe and Japan. We record trade receivables net of allowances for credit losses and chargebacks, and cash discounts for prompt payment. We apply an aging method to estimate credit losses and consider our historical loss information, adjusted to account for current economic conditions, and reasonable and supportable forecasts of future economic conditions affecting our customers. We write off trade receivables and related allowances for credit losses when it becomes probable we will not collect the amount receivable. Write-offs for the years ended December 31, 2022 and December 31, 2021 were immaterial. |
Inventory | We value inventory at the lower of cost or net realizable value. We determine the cost of inventory using the standard-cost method, which approximates actual cost based on a first-in, first-out method. We analyze our inventory levels quarterly and write down inventory subject to expiry in excess of expected requirements, or that has a cost basis in excess of its expected net realizable value. These write downs are charged to either cost of goods sold or the cost of supplied product included in collaboration services revenues in the accompanying Consolidated Statements of Income. On a quarterly basis, we analyze our estimated production levels for the following twelve-month period, which is our normal operating cycle, and reclassify inventory we expect to use or sell in periods beyond the next twelve months into other long-term assets in the accompanying Consolidated Balance Sheets. |
Property and Equipment | We record property and equipment at cost, net of depreciation. We compute depreciation using the straight-line method based on estimated useful lives of the assets, which ranges up to 15 years and depreciate leasehold improvements over the lesser of their estimated useful lives or the remainder of the lease term. We charge repairs and maintenance costs to expense as incurred. We periodically review property and equipment for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. We did not recognize any material impairment charges in any of the periods presented. |
Goodwill | We recorded goodwill amounts as the excess of purchase price over identifiable net assets acquired based on their estimated fair value. We review the carrying amount of goodwill for impairment annually and whenever events or changes in circumstance indicate that the carrying value may not be recoverable. We perform our annual assessment of the recoverability of our goodwill as of the first day of our fourth quarter. The assessment of recoverability may first consider qualitative factors to determine whether the existence of events or circumstances leads to a determination that it is more-likely-than-not that the fair value of a reporting unit is less than its carrying amount. We perform a quantitative assessment if the qualitative assessment results in a more-likely-than-not determination or if a qualitative assessment is not performed. The quantitative assessment considers whether the carrying amount of a reporting unit exceeds its fair value, in which case an impairment charge is recorded for the amount by which the carrying amount of a reporting unit exceeds its fair value, limited to the goodwill balance. We operate in one business segment, which is also considered to be our sole reporting unit and therefore, goodwill is tested for impairment at the enterprise level. |
Long-Lived Assets | The carrying value of our long-lived assets, which includes property and equipment, right-of-use assets and leasehold improvements, is reviewed for impairment whenever events or changes in circumstances indicate that the carrying value of the asset may not be recoverable. Should there be an indication of impairment, we test for recoverability by comparing the estimated undiscounted future cash flows expected to result from the use of the asset to the carrying amount of the asset or asset group. If the asset or asset group is determined to be impaired, any excess of the carrying value of the asset or asset group over its estimated fair value is recognized as an impairment loss. |
Revenue | We account for revenues under the guidance of ASU Topic 606, Revenues from Contracts with Customers (Topic 606). Under Topic 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration to which the entity is entitled to in exchange for those goods or services. To determine revenue recognition for arrangements that are within the scope of Topic 606, we perform the following five steps: (1) identify the contract(s) with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when (or as) we satisfy a performance obligation. We only apply the five-step model to contracts when it is probable that we will collect the consideration we are entitled to in exchange for the goods or services we transfer to the customer. Net Product Revenues We sell our products principally to specialty distributors and specialty pharmacy providers, or collectively, our Customers. These Customers subsequently resell our products to health care providers and patients. In addition to distribution agreements with Customers, we enter into arrangements with health care providers and payors that provide for government-mandated and/or privately-negotiated rebates, chargebacks and discounts with respect to the purchase of our products. Revenues from product sales are recognized when the Customer obtains control of our product, which occurs at a point in time, typically upon delivery to the Customer. Product Sales Discounts and Allowances We record revenues from product sales at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established primarily from discounts, chargebacks, rebates, co-pay assistance, returns and other allowances that are offered within contracts between us and our Customers, health care providers, payors and other indirect customers relating to the sales of our products. These reserves are based on the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (if the amount is payable to the Customer) or a current liability (if the amount is payable to a party other than a Customer). Where appropriate, these estimates take into consideration a range of possible outcomes that are probability-weighted for relevant factors such as our historical experience, current contractual and statutory requirements, specific known market events and trends, industry data and forecasted Customer buying and payment patterns. Overall, these reserves reflect our best estimates of the amount of consideration to which we are entitled based on the terms of our contracts. The amount of variable consideration that is included in the transaction price may be constrained, and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. Actual amounts of consideration ultimately received may differ from our estimates. If actual results in the future vary from our estimates, we will adjust these estimates, which would affect net product revenues and earnings in the period such variances become known. Chargebacks: Chargebacks are discounts that occur when contracted Customers purchase directly from a specialty distributor. Contracted Customers, which currently consist primarily of Public Health Service institutions, Federal government entities purchasing via the Federal Supply Schedule, Group Purchasing Organizations, and health maintenance organizations, generally purchase the product at a discounted price. The specialty distributor, in turn, charges back to us the difference between the price initially paid by the specialty distributor and the discounted price paid to the specialty distributor by the Customer. The allowance for chargebacks is based on actual chargebacks received and an estimate of sales to contracted Customers. Discounts for Prompt Payment: Our Customers in the U.S. receive a discount of 2% for prompt payment. We expect our Customers will earn 100% of their prompt payment discounts and, therefore, we deduct the full amount of these discounts from total product sales when revenues are recognized. Rebates: Allowances for rebates include mandated discounts under the Medicaid Drug Rebate Program, other government programs and commercial contracts. Rebate amounts owed after the final dispensing of the product to a benefit plan participant are based upon contractual agreements or legal requirements with public sector benefit providers, such as Medicaid. The allowance for rebates is based on statutory or contractual discount rates and expected utilization. Our estimates for the expected utilization of rebates are based on Customer and payer data received from the specialty pharmacies and distributors and historical utilization rates. Rebates are generally invoiced by the payer and paid in arrears, such that the accrual balance consists of an estimate of the amount expected to be incurred for the current quarter’s shipments to our Customers, plus an accrual balance for known prior quarters’ unpaid rebates. If actual future rebates vary from estimates, we may need to adjust our accruals, which would affect net product revenues in the period of adjustment. Allowances for rebates also include amounts related to the Medicare Part D Coverage Gap Discount Program. In the U.S. during 2020, the Medicare Part D prescription drug benefit mandated participating manufacturers to fund 70% of the Medicare Part D insurance coverage gap for prescription drugs sold to eligible patients. Our estimates for expected Medicare Part D coverage gap amounts are based on Customer and payer data received from specialty pharmacies and distributors and historical utilization rates. Funding of the coverage gap is invoiced and paid in arrears so that the accrual balance consists of an estimate of the amount expected to be incurred for the current quarter’s shipments to Customer, plus an accrual balance for known prior quarters’ unpaid claims. If actual future funding varies from estimates, we may need to adjust our accruals, which would affect net product revenues in the period of adjustment. Co-payment Assistance: Patients who have commercial insurance and meet certain eligibility requirements may receive co-payment assistance. We accrue a liability for co-payment assistance based on actual program participation and estimates of program redemption using Customer data provided by the specialty distributor that administers the copay program. Other Customer Credits: We pay fees to our Customers for account management, data management and other administrative services. To the extent the services received are distinct from the sale of products to the Customer, we classify these payments in selling, general and administrative expenses in our Consolidated Statements of Income. Collaboration Revenues We assess whether our collaboration agreements are subject to ASC Topic 808, Collaborative Arrangements (Topic 808) based on whether they involve joint operating activities and whether both parties have active participation in the arrangement and are exposed to significant risks and rewards. To the extent that the arrangement falls within the scope of Topic 808, we apply by analogy the unit of account guidance under Topic 606 to identify distinct performance obligations, and then determine whether a customer relationship exists for each distinct performance obligation. If we determine a performance obligation within the arrangement is with a customer, we apply the guidance in Topic 606. If a portion of a distinct bundle of goods or services within an arrangement is not with a customer, then the unit of account is not within the scope of Topic 606, and the recognition and measurement of that unit of account shall be based on analogy to authoritative accounting literature or, if there is no appropriate analogy, a reasonable, rational, and consistently applied accounting policy election. We enter into collaboration arrangements, under which we license certain rights to our intellectual property to third parties. The terms of these arrangements typically include payments to us for one or more of the following: nonrefundable up-front license fees; development, regulatory and sales-based milestone payments; product supply services; development cost reimbursements; profit-sharing arrangements; and royalties on net sales of licensed products. As part of the accounting for these arrangements, we develop assumptions that require judgment to determine the standalone selling price for each performance obligation identified in the contract. These key assumptions may include forecasted revenues, clinical development timelines and costs, reimbursement rates for personnel costs, discount rates and probabilities of technical and regulatory success. Up-front License Fees: If the license to our intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, we recognize revenues from nonrefundable up-front fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license, which generally occurs at or near the inception of the contract. For licenses that are bundled with other promises, we utilize judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenues from nonrefundable up-front fees. We evaluate the measure of progress at the end of each reporting period and, if necessary, adjust the measure of performance and related revenue recognition. Regulatory and Development Milestone Payments: At the inception of each arrangement that includes development milestone payments, we evaluate whether the milestones are considered probable of being reached and estimate the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within our or the licensee’s control, such as regulatory approvals, are not considered probable of being achieved until uncertainty associated with the approvals has been resolved. The transaction price is then allocated to each performance obligation, on a relative standalone selling price basis, for which we recognize revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, we re-evaluate the probability of achieving such development and regulatory milestones and any related variable consideration constraint, and if necessary, adjust our estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis. Product Supply Services: Arrangements that include a promise for the future supply of drug product for either clinical development or commercial supply at the licensee’s discretion are generally considered as options. We assess if these options provide a material right to the licensee and if so, they are accounted for as separate performance obligations. Development Cost Reimbursements: Our collaboration arrangements may include promises of future clinical development and drug safety services, as well as participation on certain joint committees. When such services are provided to a customer, and they are distinct from the licenses provided to our collaboration partners, these promises are accounted for as a separate performance obligation, which we estimate using internal development costs incurred and projections through the term of the arrangements. We record revenues for these services as the performance obligations are satisfied over time based on measure of progress. However, if we conclude that our collaboration partner is not a customer for those collaborative research and development activities, we present such payments as a reduction of research and development expenses. Profit-sharing Arrangements: Under the terms of our collaboration agreement with Genentech for cobimetinib, we are entitled to a share of U.S. profits and losses received in connection with the commercialization of cobimetinib. We account for this arrangement in accordance with Topic 606. We have determined that we are an agent under the agreement and therefore revenues are recorded net of costs incurred. We record revenues for the variable consideration associated with the profits and losses under the collaboration agreement when it is probable that a significant reversal in the amount of cumulative revenues recognized will not occur. Royalty and Sales-based Milestone Payments: For arrangements that include royalties and sales-based milestone payments, including milestone payments earned for the first commercial sale of a product, the license is deemed to be the predominant item to which such payments relate and we recognize revenues at the later of when the related sales occur or when the performance obligation to which the royalty has been allocated has been satisfied. Cost of Goods Sold Cost of goods sold is related to our product revenues and consists primarily of a 3% royalty we are required to pay on all net sales of any product incorporating cabozantinib, the cost of manufacturing, indirect labor costs, write-downs related to expiring and excess inventory, shipping and other third-party logistics and distribution costs for our product. |
Research and Development Expenses | Research and development expenses consist of (1) direct and indirect internal costs for drug discovery; (2) upfront license and project initiation fees, license option fees and option exercise fees, funded research and milestone payments incurred or probable to be incurred for our in-licensing arrangements with our collaboration partners for research programs in development and prior to regulatory approval; and (3) development costs associated with our clinical trial projects, which include fees paid to Contract Research Organizations (CRO) performing work on our behalf. Our clinical trial projects have been executed with support from third-party CROs, who specialize in conducting and managing global clinical trials. We accrue expenses for clinical trial activities performed by the CROs based upon the estimated amount of work completed on each trial. For clinical trial expenses, the significant factors used in estimating |
Leases | We determine if an arrangement includes a lease at the inception of the agreement. For each of our lease arrangements, we record a right-of-use asset representing our right to use an underlying asset for the lease term and a lease liability representing our obligation to make lease payments. Operating lease right-of-use assets and liabilities are recognized at the lease commencement date based on the net present value of lease payments over the lease term. In determining the discount rate used to calculate the net present value of lease payments, we use our incremental borrowing rate based on the information available at the lease commencement date. Our leases may include options to extend or terminate the lease which are included in the lease term when it is reasonably certain that we will exercise any such options. Lease expense for our operating leases is recognized on a straight-line basis over the lease term. We have elected not to apply the recognition requirements of ASU 2016-02 , Leases (Topic 842) for short-term leases. |
Advertising | We expense the costs of advertising, including promotional expenses, as incurred. Advertising expenses are recorded in selling, general and administrative expenses. |
Stock-Based Compensation | We account for stock-based payments to employees, including grants of service-based restricted stock units (RSUs), performance-based restricted stock units (PSUs), service-based stock options and purchases under our 2000 Employee Stock Purchase Plan (ESPP) in accordance with ASC 718, Compensation-Stock Compensation , which requires that stock-based payments (to the extent they are compensatory) be recognized in our Consolidated Statements of Income based on their fair values. We account for forfeitures of stock-based awards as they occur. The expense for stock-based compensation is based on the grant date fair value of the award. The grant date fair value of RSUs and PSUs are estimated as the value of the underlying shares of our common stock. The grant date fair values are estimated using a Monte Carlo simulation pricing model for certain PSUs and RSUs with market vesting conditions and a Black-Scholes Merton option pricing model for stock options. Both pricing models require the input of subjective assumptions. These variables include, but are not limited to, the expected volatility of our stock price and the expected term of the awards. We consider both implied and historical volatility when developing an estimate of expected volatility. We estimate the term using historical data. We recognize compensation expense over the requisite service period on an accelerated basis for awards with a market or performance condition and on a straight-line basis for service-based stock options and awards. Compensation expense related to PSUs is recognized when we determine that it is probable that the performance goals will be achieved, which we assess on a quarterly basis. Compensation expense related to RSUs with market vesting conditions is recognized regardless of the outcome of the market conditions. |
Variable Interest Entities | We continually assess our ownership, contractual and other interests in entities that are not wholly-owned whether we are the primary beneficiary of a variable interest entity (VIE) and therefore we must consolidate the entity. We apply a qualitative approach that determines whether we have both (1) the power to direct the activities that most significantly impact the economic performance of the entity and (2) the obligation to absorb losses of, or the right to receive benefits from, the entity that could potentially be significant to that entity. We perform this assessment, as changes to existing relationships or future transactions may result in consolidation or deconsolidation of a VIE. |
Provision for Income Taxes | Our provision for income taxes is computed under the asset and liability method. Significant estimates are required in determining our provision for income taxes. Some of these estimates are based on interpretations of existing tax laws or regulations. We recognize deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns. Under this method, deferred tax assets and liabilities are determined on the basis of the difference between the tax basis of assets and liabilities and their respective financial reporting amounts (temporary differences) at enacted tax rates in effect for the years in which the differences are expected to reverse. A valuation allowance is established for deferred tax assets for which it is more likely than not that some portion or all of the deferred tax assets, including net operating losses and tax credits, will not be realized. We periodically re-assess the need for a valuation allowance against our deferred tax assets based on various factors including our historical earnings experience by taxing jurisdiction, and forecasts of future operating results and utilization of net operating losses and tax credits prior to their expiration. Significant judgment is required in making this assessment and, to the extent that a reversal of any portion of our valuation allowance against our deferred tax assets is deemed appropriate, a tax benefit will be recognized against our provision for income taxes in the period of such reversal. Based on our evaluation of various factors, including our achievement of a cumulative three-year income position as of December 31, 2022 and forecasts of future operating results, we do not have a valuation allowance against our deferred tax assets as described in “Note 9. Provision For Income Taxes”, below. We continue to maintain a valuation allowance against our California state deferred tax assets. We recognize tax benefits from uncertain tax positions only if it is more likely than not that the tax position will be sustained upon examination by the tax authorities based on the technical merits of the position. An adverse resolution of one or more of these uncertain tax positions in any period could have a material impact on the results of operations for that period. |
Revenues (Tables)
Revenues (Tables) | 12 Months Ended |
Dec. 30, 2022 | |
Revenue from Contract with Customer [Abstract] | |
Schedule of Disaggregation of Revenue | Revenues consisted of the following (in thousands): Year Ended December 31, 2022 2021 2020 Product revenues: Gross product revenues $ 1,951,169 $ 1,452,913 $ 962,591 Discounts and allowances (549,926) (375,657) (221,041) Net product revenues 1,401,243 1,077,256 741,550 Collaboration revenues: License revenues 162,056 249,956 167,295 Collaboration services revenues 47,763 107,758 78,693 Total collaboration revenues 209,819 357,714 245,988 Total revenues $ 1,611,062 $ 1,434,970 $ 987,538 Net product revenues by product were as follows (in thousands): Year Ended December 31, 2022 2021 2020 CABOMETYX $ 1,375,909 $ 1,054,050 $ 718,687 COMETRIQ 25,334 23,206 22,863 Net product revenues $ 1,401,243 $ 1,077,256 $ 741,550 |
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: Year Ended December 31, 2022 2021 2020 Affiliates of AmerisourceBergen Corporation 18 % 14 % 11 % Affiliates of McKesson Corporation 17 % 14 % 12 % Affiliates of CVS Health Corporation 17 % 14 % 14 % Ipsen Pharma SAS 10 % 21 % 15 % Accredo Health, Incorporated 10 % 9 % 9 % Affiliates of Optum Specialty Pharmacy 10 % 8 % 11 % As of December 31, 2022 and 2021, the percentage of trade receivables by customer who individually accounted for 10% or more of our trade receivables were as follows: December 31, 2022 2021 Affiliates of McKesson Corporation 22 % 10 % Ipsen Pharma SAS 20 % 50 % Affiliates of AmerisourceBergen Corporation 18 % 11 % Affiliates of CVS Health Corporation 18 % 9 % Cardinal Health, Inc. 11 % 6 % |
Schedule of Revenues Disaggregated by Geographic Region | Total revenues by geographic region were as follows (in thousands): Year Ended December 31, 2022 2021 2020 U.S. $ 1,413,743 $ 1,089,396 $ 752,890 Europe 168,592 302,073 151,631 Japan 28,727 43,501 83,017 Total revenues $ 1,611,062 $ 1,434,970 $ 987,538 |
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, 2020 $ 9,853 $ 3,279 $ 17,404 $ 30,536 Provision related to sales made in: Current period 243,119 30,728 100,361 374,208 Prior periods (64) (111) 1,624 1,449 Payments and customer credits issued (238,283) (25,021) (94,564) (357,868) Balance at December 31, 2021 14,625 8,875 24,825 48,325 Provision related to sales made in: Current period 355,865 50,312 143,516 549,693 Prior periods 611 (169) (209) 233 Payments and customer credits issued (344,220) (44,094) (132,706) (521,020) Balance at December 31, 2022 $ 26,881 $ 14,924 $ 35,426 $ 77,231 |
Schedule of Other Assets and Other Liabilities | Contract assets and liabilities were as follows (in thousands): December 31, 2022 2021 Contract assets (1) $ 1,659 $ 1,665 Contract liabilities: Current portion (2) $ 7,488 $ 7,814 Long-term portion (3) 6,582 8,739 Total contract liabilities $ 14,070 $ 16,553 ____________________ (1) Presented in other long-term assets in the accompanying Consolidated Balance Sheets. (2) Presented in other current liabilities in the accompanying Consolidated Balance Sheets. |
Collaboration Agreements And _2
Collaboration Agreements And Business Development Activities (Tables) | 12 Months Ended |
Dec. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedule of Collaborative Revenues Under Collaboration Agreement | Revenues under the collaboration agreement with Ipsen were as follows (in thousands): Year Ended December 31, 2022 2021 2020 License revenues $ 133,732 $ 207,982 $ 93,495 Collaboration services revenues 34,860 94,091 58,136 Total $ 168,592 $ 302,073 $ 151,631 Collaboration services revenues under the collaboration agreement with Takeda were as follows (in thousands): Year Ended December 31, 2022 2021 2020 License revenues $ 11,335 $ 26,058 $ 61,115 Collaboration services revenues 12,903 13,667 20,557 Total collaboration revenues $ 24,238 $ 39,725 $ 81,672 |
Cash and Investments (Tables)
Cash and Investments (Tables) | 12 Months Ended |
Dec. 30, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Reconciliation of Cash, Cash Equivalents, and Restricted Cash | A reconciliation of cash, cash equivalents, and restricted cash equivalents reported in the accompanying Consolidated Balance Sheets to the amount reported within the accompanying Consolidated Statements of Cash Flows was as follows (in thousands): December 31, 2022 2021 Cash and cash equivalents $ 501,195 $ 647,169 Restricted cash equivalents included in other long-term assets 1,482 16,722 Cash, cash equivalents and restricted cash equivalents as reported within the accompanying Consolidated Statements of Cash Flows $ 502,677 $ 663,891 |
Reconciliation of Cash, Cash Equivalents, and Restricted Cash | A reconciliation of cash, cash equivalents, and restricted cash equivalents reported in the accompanying Consolidated Balance Sheets to the amount reported within the accompanying Consolidated Statements of Cash Flows was as follows (in thousands): December 31, 2022 2021 Cash and cash equivalents $ 501,195 $ 647,169 Restricted cash equivalents included in other long-term assets 1,482 16,722 Cash, cash equivalents and restricted cash equivalents as reported within the accompanying Consolidated Statements of Cash Flows $ 502,677 $ 663,891 |
Schedule of Investments by Security Type | Cash, cash equivalents, restricted cash equivalents and investments consisted of the following (in thousands): December 31, 2022 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Debt securities available-for-sale: Commercial paper $ 722,018 $ — $ — $ 722,018 Corporate bonds 810,439 541 (13,132) 797,848 U.S. Treasury and government-sponsored enterprises 338,218 48 (5,679) 332,587 Municipal bonds 16,385 — (223) 16,162 Total debt securities available-for-sale 1,887,060 589 (19,034) 1,868,615 Cash 41 — — 41 Money market funds 94,344 — — 94,344 Certificates of deposit 103,681 — — 103,681 Total cash, cash equivalents, restricted cash equivalents and investments $ 2,085,126 $ 589 $ (19,034) $ 2,066,681 December 31, 2021 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Debt securities available-for-sale: Commercial paper $ 945,801 $ 42 $ (2) $ 945,841 Corporate bonds 541,774 876 (1,672) 540,978 U.S. Treasury and government-sponsored enterprises 33,965 1 (21) 33,945 Municipal bonds 12,924 15 (35) 12,904 Total debt securities available-for-sale 1,534,464 934 (1,730) 1,533,668 Cash 135,653 — — 135,653 Money market funds 66,531 — — 66,531 Certificates of deposit 119,056 — — 119,056 Total cash, cash equivalents, restricted cash equivalents and investments $ 1,855,704 $ 934 $ (1,730) $ 1,854,908 |
Schedule of Fair Value and Gross Unrealized Losses of Investments Available-for-Sale in an Unrealized Loss Position | The fair value and gross unrealized losses on debt securities available-for-sale in an unrealized loss position were as follows (in thousands): December 31, 2022 Fair Value Gross Unrealized Losses Corporate bonds $ 706,711 $ (13,132) U.S. Treasury and government-sponsored enterprises 308,307 (5,679) Municipal bonds 15,792 (223) Total $ 1,030,810 $ (19,034) December 31, 2021 Fair Value Gross Unrealized Losses Corporate bonds $ 385,053 $ (1,672) Commercial paper 43,290 (2) U.S. Treasury and government-sponsored enterprises 18,962 (21) Municipal bonds 7,475 (35) Total $ 454,780 $ (1,730) |
Schedule of Fair Value of Cash Equivalents and Investments by Contractual Maturity | The fair value of debt securities available-for-sale by contractual maturity was as follows (in thousands): December 31, 2022 2021 Maturing in one year or less $ 1,114,884 $ 1,168,256 Maturing after one year through five years 753,731 365,412 Total debt securities available-for-sale $ 1,868,615 $ 1,533,668 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Schedule of Fair Value of Financial Assets Measured on a Recurring Basis | The classifications within the fair value hierarchy of our financial assets that were measured and recorded at fair value on a recurring basis were as follows (in thousands): December 31, 2022 Level 1 Level 2 Total Commercial paper $ — $ 722,018 $ 722,018 Corporate bonds — 797,848 797,848 U.S. Treasury and government-sponsored enterprises — 332,587 332,587 Municipal bonds — 16,162 16,162 Total debt securities available-for-sale — 1,868,615 1,868,615 Money market funds 94,344 — 94,344 Certificates of deposit — 103,681 103,681 Total financial assets carried at fair value $ 94,344 $ 1,972,296 $ 2,066,640 December 31, 2021 Level 1 Level 2 Total Commercial paper $ — $ 945,841 $ 945,841 Corporate bonds — 540,978 540,978 U.S. Treasury and government-sponsored enterprises — 33,945 33,945 Municipal bonds — 12,904 12,904 Total debt securities available-for-sale — 1,533,668 1,533,668 Money market funds 66,531 — 66,531 Certificates of deposit — 119,056 119,056 Total financial assets carried at fair value $ 66,531 $ 1,652,724 $ 1,719,255 |
Inventory (Tables)
Inventory (Tables) | 12 Months Ended |
Dec. 30, 2022 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory | Inventory consisted of the following (in thousands): December 31, 2022 2021 Raw materials $ 8,077 $ 8,867 Work in process 43,564 27,717 Finished goods 10,635 12,927 Total $ 62,276 $ 49,511 Balance Sheet classification: Current portion included in inventory $ 33,299 $ 27,493 Long-term portion included in other long-term assets 28,977 22,018 Total $ 62,276 $ 49,511 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 30, 2022 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment | Property and equipment consisted of the following (in thousands): Estimated Useful Lives December 31, 2022 2021 Leasehold improvements up to 15 years $ 83,334 $ 73,589 Computer equipment and software up to 3 years 19,569 14,877 Furniture and fixtures 7 years 24,054 15,780 Laboratory equipment 5 years 39,606 23,744 Construction in progress 4,933 16,872 Total property and equipment 171,496 144,862 Less: accumulated depreciation (60,872) (40,831) Total property and equipment, net $ 110,624 $ 104,031 |
Employee Benefit Plans (Tables)
Employee Benefit Plans (Tables) | 12 Months Ended |
Dec. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Allocated Employee Stock-Based Compensation Expense | We allocated the stock-based compensation expense for our equity incentive plans and our ESPP as follows (in thousands): Year Ended December 31, 2022 2021 2020 Research and development $ 45,350 $ 46,654 $ 37,198 Selling, general and administrative 62,224 73,166 67,872 Total stock-based compensation expense $ 107,574 $ 119,820 $ 105,070 Year Ended December 31, 2022 2021 2020 Stock options $ 12,790 $ 19,048 $ 19,863 Restricted stock units 69,775 53,629 35,675 Performance stock units 21,616 43,428 47,106 ESPP 3,393 3,715 2,426 Total stock-based compensation expense $ 107,574 $ 119,820 $ 105,070 |
Schedule of Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value | The weighted average grant-date fair value per share of stock options and ESPP purchases were as follows: Year Ended December 31, 2022 2021 2020 Stock options $ 8.36 $ 9.04 $ 9.44 ESPP $ 5.80 $ 6.12 $ 6.12 |
Schedule of Fair Value of Employee Share-Based Payments Awards Stock Option Assumptions and Weighted Average Fair Values | The grant-date fair value of stock option grants and ESPP purchases was estimated using the following assumptions: Year Ended December 31, 2022 2021 2020 Stock options: Risk-free interest rate 2.35 % 0.74 % 0.30 % Dividend yield — % — % — % Volatility 48 % 51 % 54 % Expected life 4.6 years 4.6 years 4.4 years ESPP: Risk-free interest rate 1.49 % 0.08 % 0.79 % Dividend yield — % — % — % Volatility 45 % 47 % 52 % Expected life 6 months 6 months 6 months |
Schedule of Fair Value of Employee Share-Based Payments Awards ESPP Assumptions and Weighted Average Fair Values | The grant-date fair value of stock option grants and ESPP purchases was estimated using the following assumptions: Year Ended December 31, 2022 2021 2020 Stock options: Risk-free interest rate 2.35 % 0.74 % 0.30 % Dividend yield — % — % — % Volatility 48 % 51 % 54 % Expected life 4.6 years 4.6 years 4.4 years ESPP: Risk-free interest rate 1.49 % 0.08 % 0.79 % Dividend yield — % — % — % Volatility 45 % 47 % 52 % Expected life 6 months 6 months 6 months |
Schedule of All Stock Option Activity | Activity for stock options during the year ended December 31, 2022 was as follows (in thousands , except per share amounts): Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term Aggregate Intrinsic Value Stock options outstanding at December 31, 2021 13,671 $ 16.79 Granted 589 $ 19.99 Exercised (2,743) $ 5.74 Cancelled (635) $ 21.29 Stock options outstanding at December 31, 2022 10,882 $ 19.49 3.0 years $ 9,377 Stock options exercisable at December 31, 2022 8,743 $ 19.17 2.4 years $ 9,373 |
Schedule of All RSU Activity | Activity for RSUs during the year ended December 31, 2022 was as follows (in thousands, except per share amounts): Shares Weighted Average Grant Date Fair Value Weighted Average Remaining Contractual Term Aggregate Intrinsic Value RSUs outstanding at December 31, 2021 6,828 $ 21.58 Awarded 7,933 $ 21.84 Vested and released (2,164) $ 21.31 Forfeited (1,303) $ 21.43 RSUs outstanding at December 31, 2022 11,294 $ 21.83 1.8 years $ 181,156 Activity for PSUs, during the year ended December 31, 2022 was as follows (in thousands , except per share amounts): Shares Weighted Average Grant Date Fair Value Weighted Average Remaining Contractual Term Aggregate Intrinsic Value PSUs outstanding at December 31, 2021 6,310 $ 23.00 Awarded — $ — Vested and released (942) $ 21.32 Forfeited (404) $ 24.56 PSUs outstanding at December 31, 2022 4,964 $ 23.26 2.3 years $ 79,628 |
Schedule of Share-Based Payment Award, Equity Instruments Other Than Options, Valuation Assumptions | We used a Monte Carlo simulation model and the following assumptions to determine the grant date fair value of $33.17 per share for the 2022 TSR-based RSUs: Fair value of Exelixis common stock on grant date $ 20.70 Expected volatility 46.85 % Risk-free interest rate 1.59 % Dividend yield — % A Monte Carlo simulation model was used to determine the grant date fair value of $24.54 for the 2021 PSUs based on the following assumptions: Fair value of Exelixis common stock on grant date $ 21.31 Expected volatility 49.21 % Risk-free interest rate 0.29 % Dividend yield — % |
Provision For Income Taxes (Tab
Provision For Income Taxes (Tables) | 12 Months Ended |
Dec. 30, 2022 | |
Income Tax Disclosure [Abstract] | |
Schedule of Components of Income Tax Expense (Benefit) | Our income before income taxes is derived solely from within the U.S. Our provision for income taxes was as follows (in thousands): Year Ended December 31, 2022 2021 2020 Current: Federal $ 100,525 $ 11,338 $ — State 11,903 5,224 3,791 Total current tax expense $ 112,428 $ 16,562 $ 3,791 Deferred: Federal $ (54,223) $ 46,416 $ 14,886 State (6,135) 113 379 Total deferred tax expense (60,358) 46,529 15,265 Provision for income taxes $ 52,070 $ 63,091 $ 19,056 |
Schedule of Reconciliation of Income Taxes At The Statutory Federal Income Tax Rate to Net Income Taxes | The reconciliation of the U.S. federal income tax provision at the statutory federal income tax rate of 21% for each of the years ended December 31, 2022, 2021 and 2020, respectively, to our provision for income taxes was as follows (in thousands): Year Ended December 31, 2022 2021 2020 U.S. federal income tax provision at statutory rate $ 49,213 $ 61,772 $ 27,476 State tax (benefit) expense (2,632) 1,336 (2,232) Change in valuation allowance 7,162 2,883 5,525 Research credits (14,130) (6,263) (11,356) Stock-based compensation (2,864) (11,831) (20,399) Non-deductible executive compensation 4,549 11,182 18,067 Branded prescription drug fee 3,855 2,897 2,537 Non-deductible warrant purchase 6,300 — — Other 617 1,115 (562) Provision for income taxes $ 52,070 $ 63,091 $ 19,056 |
Schedule of Deferred Assets and Liabilities | Our deferred tax assets and liabilities were as follows (in thousands): December 31, 2022 2021 Deferred tax assets: Net operating loss carryforwards $ 33,635 $ 17,993 Tax credit carryforwards 40,217 101,460 Depreciation and amortization 176,208 7,764 Stock-based compensation 27,531 23,162 Lease liabilities 46,759 12,385 Accruals and reserves not currently deductible 22,418 19,531 Deferred revenue 7,656 8,040 Other assets 6,746 1,303 Total deferred tax assets 361,170 191,638 Valuation allowance (77,230) (70,068) Net deferred tax assets 283,940 121,570 Deferred tax liabilities: Lease right-of-use assets (52,830) (9,907) Net deferred taxes $ 231,110 $ 111,663 |
Schedule of Unrecognized Tax Benefits | The following table summarizes the activity related to our unrecognized tax benefits (in thousands): Year Ended December 31, 2022 2021 2020 Beginning balance $ 83,583 $ 80,941 $ 79,078 Change relating to prior year provision 715 728 591 Change relating to current year provision 4,129 2,215 3,305 Reductions based on the lapse of the applicable statutes of limitations (721) (301) (2,033) Ending balance $ 87,706 $ 83,583 $ 80,941 |
Net Income Per Share (Tables)
Net Income Per Share (Tables) | 12 Months Ended |
Dec. 30, 2022 | |
Earnings Per Share [Abstract] | |
Schedule of Reconciliation 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): Year Ended December 31, 2022 2021 2020 Numerator: Net income $ 182,282 $ 231,063 $ 111,781 Denominator: Weighted-average common shares outstanding - basic 321,526 314,884 308,271 Dilutive securities 3,030 7,475 9,730 Weighted-average common shares outstanding - diluted 324,556 322,359 318,001 Net income per share - basic $ 0.57 $ 0.73 $ 0.36 Net income per share - diluted $ 0.56 $ 0.72 $ 0.35 |
Schedule of Potential Shares of Common Stock Not Included In Computation of Diluted Net Income Per Share | The weighted-average potential common shares excluded from our calculation were as follows (in thousands): Year Ended December 31, 2022 2021 2020 Anti-dilutive securities and contingently issuable shares excluded 17,063 14,305 10,959 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Balance Sheet Classification of Lease Liabilities | The balance sheet classification of our operating lease assets and liabilities were as follows (in thousands): December 31, 2022 2021 Assets: Right-of-use assets included in other long-term assets $ 234,811 $ 45,122 Liabilities: Current portion included in other current liabilities $ 17,659 $ 5,137 Long-term portion of operating lease liabilities 190,170 51,272 Total operating lease liabilities $ 207,829 $ 56,409 |
Schedule of Components of Lease Expense | The components of operating lease costs were as follows (in thousands): Year Ended December 31, 2022 2021 2019 Operating lease cost $ 18,315 $ 5,332 $ 4,825 Variable lease cost 3,098 2,685 2,830 Total operating lease costs $ 21,413 $ 8,017 $ 7,655 |
Schedule of Maturities of Operating Lease Liabilities | As of December 31, 2022, the maturities of our operating lease liabilities were as follows (in thousands): Year Ended December 31, Amount 2023 $ 18,057 2024 23,682 2025 23,111 2026 23,608 2027 24,313 Thereafter 206,605 Total lease payments 319,376 Less: Imputed interest (88,310) Future tenant improvement reimbursements (23,237) Operating lease liabilities $ 207,829 |
Organization and Summary of S_3
Organization and Summary of Significant Accounting Policies (Details) | 12 Months Ended | ||
Dec. 30, 2022 USD ($) product segment country | Dec. 31, 2021 USD ($) | Jan. 01, 2021 USD ($) | |
Organization And Summary Of Significant Policies [Line Items] | |||
Number of countries with FDA approval, excluding the U.S. | country | 62 | ||
Number of operating segments | segment | 1 | ||
Impairment charge on goodwill | $ | $ 0 | $ 0 | $ 0 |
Percent discount for prompt payment | 2% | ||
Discount expected to be earned | 100% | ||
Medicare Part D funding mandate | 70% | ||
Cost of goods sold is related to product | 3% | ||
Advertising expense | $ | $ 41,600,000 | $ 31,800,000 | $ 25,100,000 |
Maximum | |||
Organization And Summary Of Significant Policies [Line Items] | |||
Estimated useful lives | 15 years | ||
Resulting From Discovery Efforts | |||
Organization And Summary Of Significant Policies [Line Items] | |||
Number of products that entered in the commercial marketplace | product | 4 | ||
Products Derived From Other Compounds | |||
Organization And Summary Of Significant Policies [Line Items] | |||
Number of products that entered in the commercial marketplace | product | 2 |
Revenues - Revenues by Disaggre
Revenues - Revenues by Disaggregated Category (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 30, 2022 | Dec. 31, 2021 | Jan. 01, 2021 | |
Disaggregation of Revenue [Line Items] | |||
Total revenues | $ 1,611,062 | $ 1,434,970 | $ 987,538 |
Gross product revenues | |||
Disaggregation of Revenue [Line Items] | |||
Total revenues | 1,951,169 | 1,452,913 | 962,591 |
Discounts and allowances | |||
Disaggregation of Revenue [Line Items] | |||
Total revenues | (549,926) | (375,657) | (221,041) |
Net product revenues | |||
Disaggregation of Revenue [Line Items] | |||
Total revenues | 1,401,243 | 1,077,256 | 741,550 |
License revenues | |||
Disaggregation of Revenue [Line Items] | |||
Total revenues | 162,056 | 249,956 | 167,295 |
Collaboration services revenues | |||
Disaggregation of Revenue [Line Items] | |||
Total revenues | 47,763 | 107,758 | 78,693 |
Total collaboration revenues | |||
Disaggregation of Revenue [Line Items] | |||
Total revenues | $ 209,819 | $ 357,714 | $ 245,988 |
Revenues - Net Product Revenues
Revenues - Net Product Revenues Disaggregated by Product (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 30, 2022 | Dec. 31, 2021 | Jan. 01, 2021 | |
Disaggregation of Revenue [Line Items] | |||
Net product revenues | $ 1,611,062 | $ 1,434,970 | $ 987,538 |
Net product revenues | |||
Disaggregation of Revenue [Line Items] | |||
Net product revenues | 1,401,243 | 1,077,256 | 741,550 |
CABOMETYX | |||
Disaggregation of Revenue [Line Items] | |||
Net product revenues | 1,375,909 | 1,054,050 | 718,687 |
COMETRIQ | |||
Disaggregation of Revenue [Line Items] | |||
Net product revenues | $ 25,334 | $ 23,206 | $ 22,863 |
Revenues - Revenues Disaggregat
Revenues - Revenues Disaggregated by Significant Customer (Details) - Customer concentration risk | 12 Months Ended | ||
Dec. 30, 2022 | Dec. 31, 2021 | Jan. 01, 2021 | |
Affiliates of AmerisourceBergen Corporation | Sales revenue, net | |||
Concentration Risk [Line Items] | |||
Percent of total revenues | 18% | 14% | 11% |
Affiliates of AmerisourceBergen Corporation | Accounts Receivable | |||
Concentration Risk [Line Items] | |||
Percent of total revenues | 18% | 11% | |
Affiliates of McKesson Corporation | Sales revenue, net | |||
Concentration Risk [Line Items] | |||
Percent of total revenues | 17% | 14% | 12% |
Affiliates of McKesson Corporation | Accounts Receivable | |||
Concentration Risk [Line Items] | |||
Percent of total revenues | 22% | 10% | |
Affiliates of CVS Health Corporation | Sales revenue, net | |||
Concentration Risk [Line Items] | |||
Percent of total revenues | 17% | 14% | 14% |
Affiliates of CVS Health Corporation | Accounts Receivable | |||
Concentration Risk [Line Items] | |||
Percent of total revenues | 18% | 9% | |
Ipsen Pharma SAS | Sales revenue, net | |||
Concentration Risk [Line Items] | |||
Percent of total revenues | 10% | 21% | 15% |
Ipsen Pharma SAS | Accounts Receivable | |||
Concentration Risk [Line Items] | |||
Percent of total revenues | 20% | 50% | |
Accredo Health, Incorporated | Sales revenue, net | |||
Concentration Risk [Line Items] | |||
Percent of total revenues | 10% | 9% | 9% |
Affiliates of Optum Specialty Pharmacy | Sales revenue, net | |||
Concentration Risk [Line Items] | |||
Percent of total revenues | 10% | 8% | 11% |
Cardinal Health, Inc. | Accounts Receivable | |||
Concentration Risk [Line Items] | |||
Percent of total revenues | 11% | 6% |
Revenues - Revenues Disaggreg_2
Revenues - Revenues Disaggregated by Geographic Region (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 30, 2022 | Dec. 31, 2021 | Jan. 01, 2021 | |
Disaggregation of Revenue [Line Items] | |||
Total revenues | $ 1,611,062 | $ 1,434,970 | $ 987,538 |
U.S. | |||
Disaggregation of Revenue [Line Items] | |||
Total revenues | 1,413,743 | 1,089,396 | 752,890 |
Europe | |||
Disaggregation of Revenue [Line Items] | |||
Total revenues | 168,592 | 302,073 | 151,631 |
Japan | |||
Disaggregation of Revenue [Line Items] | |||
Total revenues | $ 28,727 | $ 43,501 | $ 83,017 |
Revenues - Activities and Endin
Revenues - Activities and Ending Reserve Balances for Significant Categories of Discounts and Allowances (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 30, 2022 | Dec. 31, 2021 | |
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | ||
Balance at beginning of period | $ 48,325 | $ 30,536 |
Provision related to sales made in: | ||
Current period | 549,693 | 374,208 |
Prior periods | 233 | 1,449 |
Payments and customer credits issued | (521,020) | (357,868) |
Balance at end of period | 77,231 | 48,325 |
Chargebacks, Discounts for Prompt Payment and Other | ||
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | ||
Balance at beginning of period | 14,625 | 9,853 |
Provision related to sales made in: | ||
Current period | 355,865 | 243,119 |
Prior periods | 611 | (64) |
Payments and customer credits issued | (344,220) | (238,283) |
Balance at end of period | 26,881 | 14,625 |
Other Customer Credits/Fees and Co-pay Assistance | ||
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | ||
Balance at beginning of period | 8,875 | 3,279 |
Provision related to sales made in: | ||
Current period | 50,312 | 30,728 |
Prior periods | (169) | (111) |
Payments and customer credits issued | (44,094) | (25,021) |
Balance at end of period | 14,924 | 8,875 |
Rebates | ||
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | ||
Balance at beginning of period | 24,825 | 17,404 |
Provision related to sales made in: | ||
Current period | 143,516 | 100,361 |
Prior periods | (209) | 1,624 |
Payments and customer credits issued | (132,706) | (94,564) |
Balance at end of period | $ 35,426 | $ 24,825 |
Revenues - Contract Assets and
Revenues - Contract Assets and Liabilities (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 30, 2022 | Dec. 31, 2021 | Jan. 01, 2021 | |
Revenue from Contract with Customer [Abstract] | |||
Contract other long-term assets | $ 1,659 | $ 1,665 | |
Contract liabilities: | |||
Current portion | 7,488 | 7,814 | |
Long-term portion | 6,582 | 8,739 | |
Total contract liabilities | 14,070 | 16,553 | |
Contract revenue recognized, including revenue from deferred revenue beginning balance | 8,100 | 8,500 | $ 9,200 |
Revenues recognized for performance obligations satisfied in previous periods | 161,600 | $ 148,700 | $ 169,700 |
Transaction price allocated to our performance obligations | $ 73,000 |
Collaboration Agreements And _3
Collaboration Agreements And Business Development Activities - Ipsen Collaboration Narrative (Details) $ in Millions, $ in Millions | 12 Months Ended | ||||
Dec. 30, 2022 USD ($) | Dec. 31, 2021 USD ($) | Jan. 01, 2021 USD ($) | Dec. 31, 2016 USD ($) | Dec. 30, 2022 CAD ($) | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Milestone payments earned to date | $ 489.5 | ||||
Collaboration agreement percent of royalty on net sale | 3% | ||||
Remaining performance obligation | $ 73 | ||||
Collaborative arrangement with Ipsen | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Collaboration period to achieve specified levels of commercial performance | 10 years | ||||
Upfront payments | $ 210 | ||||
Milestone payments earned | $ 27 | $ 112.5 | $ 20 | ||
Eligible payment from collaboration for development and regulatory milestone achievement under collaborations agreement | 19.5 | ||||
Maximum amount eligible for commercial milestones under collaborations agreement | $ 350 | $ 26.5 | |||
Research and development arrangement performed for others, reimbursement for costs incurred, percent | 35% | ||||
Commercial sales milestone | $ 25.8 | ||||
Regulatory milestone | 27 | ||||
Remaining performance obligation | $ 35.4 | ||||
Collaborative arrangement with Ipsen | Minimum | Final tier | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Percent of royalty on net sale | 22% | ||||
Collaborative arrangement with Ipsen | Maximum | Final tier | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Percent of royalty on net sale | 26% | ||||
Collaborative arrangement with Ipsen | Collaboration services revenues | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Cumulative catch-up revenue recognized | $ 43.2 |
Collaboration Agreements And _4
Collaboration Agreements And Business Development Activities - Collaboration Revenues under the Collaboration Agreement with Ipsen (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 30, 2022 | Dec. 31, 2021 | Jan. 01, 2021 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Total revenues | $ 1,611,062 | $ 1,434,970 | $ 987,538 |
Collaborative Arrangement with Ipsen | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Total revenues | 168,592 | 302,073 | 151,631 |
License revenues | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Total revenues | 162,056 | 249,956 | 167,295 |
License revenues | Collaborative Arrangement with Ipsen | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Total revenues | 133,732 | 207,982 | 93,495 |
Collaboration services revenues | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Total revenues | 47,763 | 107,758 | 78,693 |
Collaboration services revenues | Collaborative Arrangement with Ipsen | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Total revenues | $ 34,860 | $ 94,091 | $ 58,136 |
Collaboration Agreements And _5
Collaboration Agreements And Business Development Activities - Takeda Collaboration Narrative (Details) - USD ($) $ in Millions | 12 Months Ended | |||
Dec. 30, 2022 | Dec. 31, 2021 | Jan. 01, 2021 | Dec. 31, 2017 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Milestone payments earned to date | $ 489.5 | |||
Collaboration agreement percent of royalty on net sale | 3% | |||
Remaining performance obligation | $ 73 | |||
Collaborative arrangement with Takeda | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Upfront payments | $ 50 | |||
Milestone payments earned to date | 127 | |||
Milestone payments earned | 0 | $ 35 | $ 66 | |
Maximum amount eligible for commercial milestones under collaborations agreement | 119 | |||
Remaining performance obligation | 37.6 | |||
Collaborative arrangement with Takeda | Initial | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Royalty tier | $ 300 | |||
Collaborative arrangement with Takeda | Initial | Minimum | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Percent of royalty on net sale | 15% | |||
Collaborative arrangement with Takeda | Initial | Maximum | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Percent of royalty on net sale | 24% | |||
Collaborative arrangement with Takeda | Final tier | Minimum | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Percent of royalty on net sale | 20% | |||
Collaborative arrangement with Takeda | Final tier | Maximum | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Percent of royalty on net sale | 30% | |||
Collaborative arrangement with Takeda | Japan | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Research and development arrangement performed for others, reimbursement for costs incurred, percent | 100% | |||
Collaboration period to achieve specified levels of commercial performance | 2 years |
Collaboration Agreements And _6
Collaboration Agreements And Business Development Activities - Collaboration Revenues under the Collaboration Agreement with Takeda (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 30, 2022 | Dec. 31, 2021 | Jan. 01, 2021 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Total revenues | $ 1,611,062 | $ 1,434,970 | $ 987,538 |
Collaborative arrangement with Takeda | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Total revenues | 24,238 | 39,725 | 81,672 |
License revenues | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Total revenues | 162,056 | 249,956 | 167,295 |
License revenues | Collaborative arrangement with Takeda | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Total revenues | 11,335 | 26,058 | 61,115 |
Collaboration services revenues | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Total revenues | 47,763 | 107,758 | 78,693 |
Collaboration services revenues | Collaborative arrangement with Takeda | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Total revenues | $ 12,903 | $ 13,667 | $ 20,557 |
Collaboration Agreements And _7
Collaboration Agreements And Business Development Activities - GSK (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 30, 2022 | Dec. 31, 2021 | Jan. 01, 2021 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Collaboration agreement percent of royalty on net sale | 3% | ||
Collaborative Arrangements with GSK and Royalty Pharma | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Royalty expense | $ 58.2 | $ 46.6 | $ 32.7 |
Collaboration Agreements And _8
Collaboration Agreements And Business Development Activities - Other Collaborations Narrative (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | |||
Nov. 30, 2022 | Jun. 30, 2022 | Dec. 30, 2022 | Dec. 31, 2021 | Jan. 01, 2021 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Total revenues | $ 1,611,062 | $ 1,434,970 | $ 987,538 | ||
Research and development | $ 891,813 | 693,716 | 547,851 | ||
Increase in diluted earnings per share (in dollars per share) | $ 0.04 | ||||
Collaborative Arrangement with Genentech | Cotellic | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Total revenues | $ 12,500 | 12,100 | 11,300 | ||
BioInvent International AB (BioInvent) | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Collaborative arrangement, upfront payment | $ 25,000 | ||||
Cybrexa Therapeutics, LLC (Cybrexa) | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Collaborative arrangement, upfront payment | $ 60,000 | 60,000 | |||
Potential future development milestone payments | 65,000 | ||||
Maximum amount of warrant to be exercised | 300,000 | ||||
Additional development regulatory and commercial milestones payments | 277,500 | ||||
Sairopa, B.V. (Sairopa) | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Collaborative arrangement, upfront payment | 40,000 | ||||
Potential future development milestone payments | 97,500 | ||||
Additional development regulatory and commercial milestones payments | 465,000 | ||||
Option to exercise, amount | 225,000 | ||||
Catalent, Inc. | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Collaborative arrangement, upfront payment | $ 30,000 | ||||
Research Collaborations, In-Licensing Arrangements and Other Business Development Activities | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Potential future development milestone payments | 652,000 | ||||
Research and development | 203,900 | $ 176,100 | $ 96,400 | ||
Decrease in research and development | $ 12,500 | ||||
Increase in basic earnings per share (in dollars per share) | $ 0.04 | ||||
Potential regulatory milestone payments | $ 634,300 | ||||
Collaborative arrangement, rights and obligations, maximum aggregate commercial milestone payments | $ 3,153,000 |
Cash and Investments - Reconcil
Cash and Investments - Reconciliation of Cash, Cash Equivalents, and Restricted Cash (Details) - USD ($) $ in Thousands | Dec. 30, 2022 | Dec. 31, 2021 | Jan. 01, 2021 | Jan. 03, 2020 |
Investments, Debt and Equity Securities [Abstract] | ||||
Cash and cash equivalents | $ 501,195 | $ 647,169 | ||
Restricted cash equivalents included in other long-term assets | 1,482 | 16,722 | ||
Cash, cash equivalents and restricted cash equivalents as reported within the accompanying Consolidated Statements of Cash Flows | $ 502,677 | $ 663,891 | $ 320,772 | $ 268,137 |
Cash and Investments - Narrativ
Cash and Investments - Narrative (Details) | Dec. 30, 2022 USD ($) numberOfSponsoredEnterprise bond investment | Dec. 31, 2021 USD ($) investment |
Debt Securities, Available-for-sale [Line Items] | ||
Interest receivable | $ 7,300,000 | $ 2,900,000 |
Number of investments in an unrealized loss position | investment | 285 | 133 |
Debt securities, available-for-sale, continuous unrealized loss position, 12 months or longer | $ 237,600,000 | |
Accumulated loss | 6,100,000 | |
Allowance for credit losses | $ 0 | $ 0 |
Corporate bonds | ||
Debt Securities, Available-for-sale [Line Items] | ||
Number of bond securities | bond | 76 | |
Municipal bonds | ||
Debt Securities, Available-for-sale [Line Items] | ||
Number of bond securities | bond | 4 | |
U.S. Treasury and government-sponsored enterprises | ||
Debt Securities, Available-for-sale [Line Items] | ||
Number of sponsored enterprises | numberOfSponsoredEnterprise | 1 |
Cash and Investments - Investme
Cash and Investments - Investments by Security Type (Details) - USD ($) $ in Thousands | Dec. 30, 2022 | Dec. 31, 2021 |
Debt securities available-for-sale: | ||
Amortized Cost | $ 1,887,060 | $ 1,534,464 |
Gross Unrealized Gains | 589 | 934 |
Gross Unrealized Losses | (19,034) | (1,730) |
Fair Value | 1,868,615 | 1,533,668 |
Cash, Cash Equivalents, Restricted Cash and Restricted Cash Equivalents | ||
Amortized Cost | 2,085,126 | 1,855,704 |
Gross Unrealized Gains | 589 | 934 |
Gross Unrealized Losses | (19,034) | (1,730) |
Fair Value | 2,066,681 | 1,854,908 |
Commercial paper | ||
Debt securities available-for-sale: | ||
Amortized Cost | 722,018 | 945,801 |
Gross Unrealized Gains | 0 | 42 |
Gross Unrealized Losses | 0 | (2) |
Fair Value | 722,018 | 945,841 |
Corporate bonds | ||
Debt securities available-for-sale: | ||
Amortized Cost | 810,439 | 541,774 |
Gross Unrealized Gains | 541 | 876 |
Gross Unrealized Losses | (13,132) | (1,672) |
Fair Value | 797,848 | 540,978 |
U.S. Treasury and government-sponsored enterprises | ||
Debt securities available-for-sale: | ||
Amortized Cost | 338,218 | 33,965 |
Gross Unrealized Gains | 48 | 1 |
Gross Unrealized Losses | (5,679) | (21) |
Fair Value | 332,587 | 33,945 |
Municipal bonds | ||
Debt securities available-for-sale: | ||
Amortized Cost | 16,385 | 12,924 |
Gross Unrealized Gains | 0 | 15 |
Gross Unrealized Losses | (223) | (35) |
Fair Value | 16,162 | 12,904 |
Cash | ||
Cash, Cash Equivalents, Restricted Cash and Restricted Cash Equivalents | ||
Amortized Cost | 41 | 135,653 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | 41 | 135,653 |
Money market funds | ||
Cash, Cash Equivalents, Restricted Cash and Restricted Cash Equivalents | ||
Amortized Cost | 94,344 | 66,531 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | 94,344 | 66,531 |
Certificates of deposit | ||
Cash, Cash Equivalents, Restricted Cash and Restricted Cash Equivalents | ||
Amortized Cost | 103,681 | 119,056 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | $ 103,681 | $ 119,056 |
Cash and Investments - Fair Val
Cash and Investments - Fair Value and Gross Unrealized Losses of Investments Available-for-Sale in an Unrealized Loss Position (Details) - USD ($) $ in Thousands | Dec. 30, 2022 | Dec. 31, 2021 |
Debt Securities, Available-for-sale [Line Items] | ||
Fair Value | $ 1,030,810 | $ 454,780 |
Gross Unrealized Losses | (19,034) | (1,730) |
Corporate bonds | ||
Debt Securities, Available-for-sale [Line Items] | ||
Fair Value | 706,711 | 385,053 |
Gross Unrealized Losses | (13,132) | (1,672) |
U.S. Treasury and government-sponsored enterprises | ||
Debt Securities, Available-for-sale [Line Items] | ||
Fair Value | 308,307 | 18,962 |
Gross Unrealized Losses | (5,679) | (21) |
Commercial paper | ||
Debt Securities, Available-for-sale [Line Items] | ||
Fair Value | 43,290 | |
Gross Unrealized Losses | (2) | |
Municipal bonds | ||
Debt Securities, Available-for-sale [Line Items] | ||
Fair Value | 15,792 | 7,475 |
Gross Unrealized Losses | $ (223) | $ (35) |
Cash and Investments - Fair V_2
Cash and Investments - Fair Value of Cash Equivalents and Investments by Contractual Maturity (Details) - USD ($) $ in Thousands | Dec. 30, 2022 | Dec. 31, 2021 |
Investments, Debt and Equity Securities [Abstract] | ||
Maturing in one year or less | $ 1,114,884 | $ 1,168,256 |
Maturing after one year through five years | 753,731 | 365,412 |
Total debt securities available-for-sale | $ 1,868,615 | $ 1,533,668 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) $ in Thousands | Dec. 30, 2022 | Dec. 31, 2021 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total debt securities available-for-sale | $ 1,868,615 | $ 1,533,668 |
Fair Value, Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total debt securities available-for-sale | 1,868,615 | 1,533,668 |
Total financial assets carried at fair value | 2,066,640 | 1,719,255 |
Level 1 | Fair Value, 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 | 94,344 | 66,531 |
Level 2 | Fair Value, Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total debt securities available-for-sale | 1,868,615 | 1,533,668 |
Total financial assets carried at fair value | 1,972,296 | 1,652,724 |
Commercial paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total debt securities available-for-sale | 722,018 | 945,841 |
Commercial paper | Fair Value, Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total debt securities available-for-sale | 722,018 | 945,841 |
Commercial paper | Level 1 | Fair Value, 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 | Fair Value, Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total debt securities available-for-sale | 722,018 | 945,841 |
Corporate bonds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total debt securities available-for-sale | 797,848 | 540,978 |
Corporate bonds | Fair Value, Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total debt securities available-for-sale | 797,848 | 540,978 |
Corporate bonds | Level 1 | Fair Value, 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 | Fair Value, Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total debt securities available-for-sale | 797,848 | 540,978 |
U.S. Treasury and government-sponsored enterprises | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total debt securities available-for-sale | 332,587 | 33,945 |
U.S. Treasury and government-sponsored enterprises | Fair Value, Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total debt securities available-for-sale | 332,587 | 33,945 |
U.S. Treasury and government-sponsored enterprises | Level 1 | Fair Value, 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 | Fair Value, Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total debt securities available-for-sale | 332,587 | 33,945 |
Municipal bonds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total debt securities available-for-sale | 16,162 | 12,904 |
Municipal bonds | Fair Value, Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total debt securities available-for-sale | 16,162 | 12,904 |
Municipal bonds | Level 1 | Fair Value, 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 | Fair Value, Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total debt securities available-for-sale | 16,162 | 12,904 |
Money market funds | Fair Value, Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 94,344 | 66,531 |
Money market funds | Level 1 | Fair Value, Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 94,344 | 66,531 |
Money market funds | Level 2 | Fair Value, Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 0 | 0 |
Certificates of deposit | Fair Value, Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 103,681 | 119,056 |
Certificates of deposit | Level 1 | Fair Value, 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 | Fair Value, Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | $ 103,681 | $ 119,056 |
Fair Value Measurements - Narra
Fair Value Measurements - Narratives (Details) - Foreign Exchange Forward € in Millions, $ in Millions | 12 Months Ended | ||
Dec. 30, 2022 USD ($) | Dec. 31, 2021 USD ($) | Dec. 30, 2022 EUR (€) derivative_instrument | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Number of forward contract outstanding | derivative_instrument | 1 | ||
Forward contract outstanding, amount | € | € 3.6 | ||
Forward contract maturity (in months) | 3 months | ||
Net gain (loss) on maturity of forward contracts | $ | $ 1.2 | $ 0.8 |
Inventory (Details)
Inventory (Details) - USD ($) $ in Thousands | Dec. 30, 2022 | Dec. 31, 2021 |
Inventory [Line Items] | ||
Raw materials | $ 8,077 | $ 8,867 |
Work in process | 43,564 | 27,717 |
Finished goods | 10,635 | 12,927 |
Total | 62,276 | 49,511 |
Current portion included in inventory | ||
Inventory [Line Items] | ||
Total | 33,299 | 27,493 |
Long-term portion included in other long-term assets | ||
Inventory [Line Items] | ||
Total | $ 28,977 | $ 22,018 |
Property and Equipment - Schedu
Property and Equipment - Schedule of Property and Equipment (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 30, 2022 | Dec. 31, 2021 | |
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 171,496 | $ 144,862 |
Less: accumulated depreciation | (60,872) | (40,831) |
Total property and equipment, net | $ 110,624 | 104,031 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Estimated useful lives | 15 years | |
Total property and equipment | $ 83,334 | 73,589 |
Computer equipment and software | ||
Property, Plant and Equipment [Line Items] | ||
Estimated useful lives | 3 years | |
Total property and equipment | $ 19,569 | 14,877 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Estimated useful lives | 7 years | |
Total property and equipment | $ 24,054 | 15,780 |
Laboratory equipment | ||
Property, Plant and Equipment [Line Items] | ||
Estimated useful lives | 5 years | |
Total property and equipment | $ 39,606 | 23,744 |
Construction in progress | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 4,933 | $ 16,872 |
Property and Equipment - Narrat
Property and Equipment - Narrative (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 30, 2022 | Dec. 31, 2021 | Jan. 01, 2021 | |
Property, Plant and Equipment [Abstract] | |||
Depreciation expense | $ 20.9 | $ 13.6 | $ 9.1 |
Employee Benefit Plans - Schedu
Employee Benefit Plans - Schedule of Allocated Employee Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 30, 2022 | Dec. 31, 2021 | Jan. 01, 2021 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Total stock-based compensation expense | $ 107,574 | $ 119,820 | $ 105,070 |
Research and development | |||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Total stock-based compensation expense | 45,350 | 46,654 | 37,198 |
Selling, general and administrative | |||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Total stock-based compensation expense | $ 62,224 | $ 73,166 | $ 67,872 |
Employee Benefit Plans - Sche_2
Employee Benefit Plans - Schedule of Employee Service Share - Based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 30, 2022 | Dec. 31, 2021 | Jan. 01, 2021 | |
ESPP | |||
Total stock-based compensation expense | $ 107,574 | $ 119,820 | $ 105,070 |
Stock options | |||
ESPP | |||
Total stock-based compensation expense | 12,790 | 19,048 | 19,863 |
Restricted stock units | |||
ESPP | |||
Total stock-based compensation expense | 69,775 | 53,629 | 35,675 |
Performance stock units | |||
ESPP | |||
Total stock-based compensation expense | 21,616 | 43,428 | 47,106 |
ESPP | |||
ESPP | |||
Total stock-based compensation expense | $ 3,393 | $ 3,715 | $ 2,426 |
Employee Benefit Plans - Narrat
Employee Benefit Plans - Narrative (Details) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||||
May 25, 2022 | Mar. 31, 2022 | Mar. 31, 2021 | Dec. 30, 2022 | Sep. 30, 2022 | Oct. 01, 2021 | Dec. 30, 2022 | Dec. 31, 2021 | Jan. 01, 2021 | |
ESPP | |||||||||
Maximum potential to vest | 25% | 25% | |||||||
Expenses relating to stock match | $ 11.7 | $ 9.5 | $ 6.7 | ||||||
Amended and Restated 2017 Equity Incentive Plan | |||||||||
ESPP | |||||||||
Increase in share reserve under 2017 plan (in shares) | 28,500,000 | ||||||||
Number of shares available for grant (in shares) | 31,971,047 | 31,971,047 | |||||||
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 | ||||||||
Minimum | |||||||||
ESPP | |||||||||
Number of months following change in control in which an employee was terminated | 1 month | ||||||||
Maximum | |||||||||
ESPP | |||||||||
Number of months following change in control in which an employee was terminated | 13 months | ||||||||
Stock options | |||||||||
ESPP | |||||||||
Expiration period | 7 years | ||||||||
Total unrecognized compensation expense | $ 16.6 | $ 16.6 | |||||||
Unrecognized compensation expense weighted-average period for recognition | 2 years 2 months 12 days | ||||||||
Intrinsic value of options exercised | $ 36.5 | 76 | 106.5 | ||||||
Cash received from option exercises and purchases under the ESPP | $ 13.9 | $ 14.8 | $ 26.9 | ||||||
Stock options | Share-based Payment Arrangement, Employee | |||||||||
ESPP | |||||||||
Award vesting period | 4 years | ||||||||
Stock options | Share-based Payment Arrangement, Nonemployee | |||||||||
ESPP | |||||||||
Award vesting period | 1 year | ||||||||
Restricted stock units | |||||||||
ESPP | |||||||||
Total unrecognized compensation expense | $ 183.6 | $ 183.6 | |||||||
Unrecognized compensation expense weighted-average period for recognition | 2 years 10 months 24 days | ||||||||
Number of awards granted (in shares) | 7,933,000 | ||||||||
Number of awards (in shares) | 11,294,000 | 11,294,000 | 6,828,000 | ||||||
Restricted stock units | Share-based Payment Arrangement, Employee | |||||||||
ESPP | |||||||||
Award vesting period | 4 years | ||||||||
Restricted stock units | Share-based Payment Arrangement, Nonemployee | |||||||||
ESPP | |||||||||
Award vesting period | 1 year | ||||||||
TSR-Based Restricted Stock Units | |||||||||
ESPP | |||||||||
Number of awards granted (in shares) | 1,003,482 | ||||||||
Maximum potential to vest | 175% | ||||||||
TSR-Based Restricted Stock Units | Share-based Payment Arrangement, Tranche One | |||||||||
ESPP | |||||||||
Award vesting period | 1 year | ||||||||
Vesting award percentage | 50% | ||||||||
ESPP | |||||||||
ESPP | |||||||||
Number of shares available for grant (in shares) | 2,561,567 | 2,561,567 | |||||||
Discount rate from market value on purchase date (as a percent) | 85% | ||||||||
Discount rate from market value on offering date (as a percent) | 85% | ||||||||
Purchase period | 6 months | ||||||||
Common stock issued (in shares) | 606,787 | 536,226 | 534,419 | ||||||
Average price per share (in dollars per share) | $ 16.63 | $ 16.63 | $ 17.76 | $ 14.55 | |||||
Proceeds from employee stock purchase plan | $ 10.1 | $ 9.5 | $ 7.8 | ||||||
Performance stock units | |||||||||
ESPP | |||||||||
Award vesting period | 1 year | ||||||||
Unrecognized compensation expense weighted-average period for recognition | 2 years 3 months 18 days | ||||||||
Number of awards granted (in shares) | 1,027,650 | 0 | |||||||
Maximum potential to vest | 200% | 100% | 200% | ||||||
Additional shares to be earned (in shares) | 2,055,300 | 4,655,680 | |||||||
Number of awards (in shares) | 4,964,000 | 4,964,000 | 6,310,000 | ||||||
Performance stock units | Achieved | |||||||||
ESPP | |||||||||
Number of awards (in shares) | 869,502 | 869,502 | |||||||
Performance stock units | Probable | |||||||||
ESPP | |||||||||
Total unrecognized compensation expense | $ 11 | $ 11 | |||||||
Performance stock units | Not Probable | |||||||||
ESPP | |||||||||
Total unrecognized compensation expense | $ 79.5 | $ 79.5 | |||||||
Performance stock units | Share-based Payment Arrangement, Tranche One | |||||||||
ESPP | |||||||||
Vesting award percentage | 50% | ||||||||
Performance Shares, Clinical Trial Results | |||||||||
ESPP | |||||||||
Number of awards granted (in shares) | 2,327,840 |
Employee Benefit Plans - Weight
Employee Benefit Plans - Weighted Average Grant Date Fair Value (Details) - $ / shares | 12 Months Ended | ||
Dec. 30, 2022 | Dec. 31, 2021 | Jan. 01, 2021 | |
Stock options | |||
ESPP | |||
Weighted average grant-date fair value (in dollars per share) | $ 8.36 | $ 9.04 | $ 9.44 |
ESPP | |||
ESPP | |||
Weighted average grant-date fair value (in dollars per share) | $ 5.80 | $ 6.12 | $ 6.12 |
Employee Benefit Plans - Sche_3
Employee Benefit Plans - Schedule of Fair Value of Employee Share-Based Payments Awards ESPP Assumptions and Weighted Average Fair Values (Details) | 12 Months Ended | ||
Dec. 30, 2022 | Dec. 31, 2021 | Jan. 01, 2021 | |
Stock options | |||
ESPP | |||
Risk-free interest rate | 2.35% | 0.74% | 0.30% |
Dividend yield | 0% | 0% | 0% |
Volatility | 48% | 51% | 54% |
Expected life | 4 years 7 months 6 days | 4 years 7 months 6 days | 4 years 4 months 24 days |
ESPP | |||
ESPP | |||
Risk-free interest rate | 1.49% | 0.08% | 0.79% |
Dividend yield | 0% | 0% | 0% |
Volatility | 45% | 47% | 52% |
Expected life | 6 months | 6 months | 6 months |
Employee Benefit Plans - Summar
Employee Benefit Plans - Summary of All Stock Option Activity (Details) $ / shares in Units, shares in Thousands, $ in Thousands | 12 Months Ended |
Dec. 30, 2022 USD ($) $ / shares shares | |
Shares | |
Options outstanding at beginning of the year (in shares) | shares | 13,671 |
Granted (in shares) | shares | 589 |
Exercised (in shares) | shares | (2,743) |
Cancelled (in shares) | shares | (635) |
Options outstanding at ending of the year (in shares) | shares | 10,882 |
Exercisable at end of the year (in shares) | shares | 8,743 |
Weighted Average Exercise Price | |
Options outstanding at beginning of the year (in dollars per share) | $ / shares | $ 16.79 |
Granted (in dollars per share) | $ / shares | 19.99 |
Exercised (in dollars per share) | $ / shares | 5.74 |
Cancelled (in dollars per share) | $ / shares | 21.29 |
Options outstanding at ending of the year (in dollars per share) | $ / shares | 19.49 |
Exercisable at end of the year (in dollars per share) | $ / shares | $ 19.17 |
Weighted average remaining contractual term, options outstanding | 3 years |
Weighted average remaining contractual term, exercisable at end of the year | 2 years 4 months 24 days |
Aggregate intrinsic value, options outstanding | $ | $ 9,377 |
Aggregate intrinsic value, exercisable at end of the year | $ | $ 9,373 |
Employee Benefit Plans - Summ_2
Employee Benefit Plans - Summary of All RSU & PSU Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended |
Mar. 31, 2021 | Dec. 30, 2022 | |
Restricted stock units | ||
Shares | ||
Awards outstanding at beginning of period (in shares) | 6,828,000 | |
Awarded (in shares) | 7,933,000 | |
Vested and released (in shares) | (2,164,000) | |
Forfeited (in shares) | (1,303,000) | |
Awards outstanding at end of period (in shares) | 11,294,000 | |
Weighted Average Grant Date Fair Value | ||
Awards outstanding at beginning of period (in dollars per share) | $ 21.58 | |
Awarded (in dollars per share) | 21.84 | |
Vested and released (in dollars per share) | 21.31 | |
Forfeited (in dollars per share) | 21.43 | |
Awards outstanding at end of period (in dollars per share) | $ 21.83 | |
Weighted Average Remaining Contractual Term | 1 year 9 months 18 days | |
Aggregate Intrinsic Value | $ 181,156 | |
Performance stock units | ||
Shares | ||
Awards outstanding at beginning of period (in shares) | 6,310,000 | |
Awarded (in shares) | 1,027,650 | 0 |
Vested and released (in shares) | (942,000) | |
Forfeited (in shares) | (404,000) | |
Awards outstanding at end of period (in shares) | 4,964,000 | |
Weighted Average Grant Date Fair Value | ||
Awards outstanding at beginning of period (in dollars per share) | $ 23 | |
Awarded (in dollars per share) | 0 | |
Vested and released (in dollars per share) | 21.32 | |
Forfeited (in dollars per share) | 24.56 | |
Awards outstanding at end of period (in dollars per share) | $ 23.26 | |
Weighted Average Remaining Contractual Term | 2 years 3 months 18 days | |
Aggregate Intrinsic Value | $ 79,628 |
Employee Benefit Plans - Estima
Employee Benefit Plans - Estimate Grant-Date Fair Value (Details) | 12 Months Ended |
Dec. 30, 2022 $ / shares | |
Performance stock units | |
ESPP | |
Weighted average grant date fair value, awarded (in dollars per share) | $ 0 |
Fair value of Exelixis common stock on grant date (in dollars per share) | $ 21.31 |
Expected volatility | 49.21% |
Risk-free interest rate | 0.29% |
Dividend yield | 0% |
Performance stock units | 2021 Awards | |
ESPP | |
Weighted average grant date fair value, awarded (in dollars per share) | $ 24.54 |
TSR-Based Restricted Stock Units | |
ESPP | |
Weighted average grant date fair value, awarded (in dollars per share) | 33.17 |
Fair value of Exelixis common stock on grant date (in dollars per share) | $ 20.70 |
Expected volatility | 46.85% |
Risk-free interest rate | 1.59% |
Dividend yield | 0% |
Provision For Income Taxes - Co
Provision For Income Taxes - Components of Income Tax Expense (Benefit) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 30, 2022 | Dec. 31, 2021 | Jan. 01, 2021 | |
Current: | |||
Federal | $ 100,525 | $ 11,338 | $ 0 |
State | 11,903 | 5,224 | 3,791 |
Total current tax expense | 112,428 | 16,562 | 3,791 |
Deferred: | |||
Federal | (54,223) | 46,416 | 14,886 |
State | (6,135) | 113 | 379 |
Total deferred tax expense | (60,358) | 46,529 | 15,265 |
Provision for income taxes | $ 52,070 | $ 63,091 | $ 19,056 |
Provision For Income Taxes - Sc
Provision For Income Taxes - Schedule of Reconciliation of Income Taxes at the Statutory Federal Income Tax Rate to Net Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 30, 2022 | Dec. 31, 2021 | Jan. 01, 2021 | |
Income Tax Disclosure [Abstract] | |||
U.S. federal income tax provision at statutory rate | $ 49,213 | $ 61,772 | $ 27,476 |
State tax (benefit) expense | (2,632) | 1,336 | (2,232) |
Change in valuation allowance | 7,162 | 2,883 | 5,525 |
Research credits | (14,130) | (6,263) | (11,356) |
Stock-based compensation | (2,864) | (11,831) | (20,399) |
Non-deductible executive compensation | 4,549 | 11,182 | 18,067 |
Branded prescription drug fee | 3,855 | 2,897 | 2,537 |
Non-deductible warrant purchase | 6,300 | 0 | 0 |
Other | 617 | 1,115 | (562) |
Provision for income taxes | $ 52,070 | $ 63,091 | $ 19,056 |
Provision For Income Taxes - _2
Provision For Income Taxes - Schedule of Deferred Assets and Liabilities (Details) - USD ($) $ in Thousands | Dec. 30, 2022 | Dec. 31, 2021 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 33,635 | $ 17,993 |
Tax credit carryforwards | 40,217 | 101,460 |
Depreciation and amortization | 176,208 | 7,764 |
Stock-based compensation | 27,531 | 23,162 |
Lease liabilities | 46,759 | 12,385 |
Accruals and reserves not currently deductible | 22,418 | 19,531 |
Deferred revenue | 7,656 | 8,040 |
Other assets | 6,746 | 1,303 |
Total deferred tax assets | 361,170 | 191,638 |
Valuation allowance | (77,230) | (70,068) |
Net deferred tax assets | 283,940 | 121,570 |
Deferred tax liabilities: | ||
Lease right-of-use assets | (52,830) | (9,907) |
Net deferred taxes | $ 231,110 | $ 111,663 |
Provision For Income Taxes - Na
Provision For Income Taxes - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 30, 2022 | Dec. 31, 2021 | Jan. 01, 2021 | Jan. 03, 2020 | |
Income Tax Examination [Line Items] | ||||
Valuation allowance | $ 77,230 | $ 70,068 | ||
Valuation allowance increase (decrease) | 7,200 | 2,900 | ||
Unrecognized tax benefits | 87,706 | $ 83,583 | $ 80,941 | $ 79,078 |
Unrecognized tax benefits that would reduce income tax provision and effective tax rate | 55,400 | |||
State and Local Jurisdiction | ||||
Income Tax Examination [Line Items] | ||||
Net operating loss carryforwards | 414,000 | |||
State and Local Jurisdiction | Research Tax Credit Carryforward | ||||
Income Tax Examination [Line Items] | ||||
Research and development tax credits | 52,000 | |||
Tax credit carryforward amount with expiration dates | $ 1,000 |
Provision For Income Taxes - _3
Provision For Income Taxes - Schedule of Unrecognized Tax Benefits (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 30, 2022 | Dec. 31, 2021 | Jan. 01, 2021 | |
Reconciliation of Unrecognized Tax Benefits, Excluding Amounts Pertaining to Examined Tax Returns [Roll Forward] | |||
Beginning balance | $ 83,583 | $ 80,941 | $ 79,078 |
Change relating to prior year provision | 715 | 728 | 591 |
Change relating to current year provision | 4,129 | 2,215 | 3,305 |
Reductions based on the lapse of the applicable statutes of limitations | (721) | (301) | (2,033) |
Ending balance | $ 87,706 | $ 83,583 | $ 80,941 |
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 | 12 Months Ended | ||
Dec. 30, 2022 | Dec. 31, 2021 | Jan. 01, 2021 | |
Numerator: | |||
Net income | $ 182,282 | $ 231,063 | $ 111,781 |
Denominator: | |||
Weighted-average common shares outstanding - basic (in shares) | 321,526 | 314,884 | 308,271 |
Dilutive securities (in shares) | 3,030 | 7,475 | 9,730 |
Weighted-average common shares outstanding - diluted (in shares) | 324,556 | 322,359 | 318,001 |
Net income per share - basic (in dollars per share) | $ 0.57 | $ 0.73 | $ 0.36 |
Net income per share - diluted (in dollars per share) | $ 0.56 | $ 0.72 | $ 0.35 |
Net Income Per Share - Potentia
Net Income Per Share - Potentially Dilutive Shares of Common Stock (Details) - shares shares in Thousands | 12 Months Ended | ||
Dec. 30, 2022 | Dec. 31, 2021 | Jan. 01, 2021 | |
Share-based Payment Arrangement | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Anti-dilutive securities and contingently issuable shares excluded (in shares) | 17,063 | 14,305 | 10,959 |
Commitments and Contingencies -
Commitments and Contingencies - Narrative (Details) $ in Millions | 12 Months Ended | ||||
Dec. 30, 2022 USD ($) ft² | Dec. 31, 2021 USD ($) | Jan. 01, 2021 USD ($) | Oct. 31, 2022 lawsuit | Sep. 30, 2022 lawsuit | |
Lessee, Lease, Description [Line Items] | |||||
Cash paid for amounts included in the measurement of lease liabilities | $ | $ 11.4 | $ 5 | $ 4.6 | ||
Weighted average operating discount rate used to determine the operating lease liability | 5.30% | ||||
Weighted average remaining lease term for operating lease | 12 years 8 months 12 days | ||||
Lease cost | $ | $ 0.4 | $ 0 | $ 0 | ||
Number of lawsuits | lawsuit | 2 | 2 | |||
Headquarters Lease | |||||
Lessee, Lease, Description [Line Items] | |||||
Area of leased property (in sqft) | ft² | 673,978 | ||||
Lease Agreements for Laboratory Spaces in Pennsylvania | |||||
Lessee, Lease, Description [Line Items] | |||||
Area of leased property (in sqft) | ft² | 28,228 |
Commitments and Contingencies_2
Commitments and Contingencies - Balance Sheet Classification of Lease Liabilities (Details) - USD ($) $ in Thousands | Dec. 30, 2022 | Dec. 31, 2021 |
Assets: | ||
Right-of-use assets included in other long-term assets | $ 234,811 | $ 45,122 |
Operating Lease, Right-of-Use Asset, Statement of Financial Position [Extensible List] | Operating Lease, Right-Of-Use Asset And Other Assets | Operating Lease, Right-Of-Use Asset And Other Assets |
Liabilities: | ||
Current portion included in other current liabilities | $ 17,659 | $ 5,137 |
Long-term portion of operating lease liabilities | 190,170 | 51,272 |
Total operating lease liabilities | $ 207,829 | $ 56,409 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | Other current liabilities | Other current liabilities |
Commitments And Contingencies_3
Commitments And Contingencies - Components of Lease Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 30, 2022 | Dec. 31, 2021 | Jan. 01, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |||
Operating lease cost | $ 18,315 | $ 5,332 | $ 4,825 |
Variable lease cost | 3,098 | 2,685 | 2,830 |
Total operating lease costs | $ 21,413 | $ 8,017 | $ 7,655 |
Commitments and Contingencies_4
Commitments and Contingencies - Maturities of Operating Lease Liabilities (Details) - USD ($) $ in Thousands | Dec. 30, 2022 | Dec. 31, 2021 |
Lessee, Operating Lease, Liability, Payment, Due [Abstract] | ||
2023 | $ 18,057 | |
2024 | 23,682 | |
2025 | 23,111 | |
2026 | 23,608 | |
2027 | 24,313 | |
Thereafter | 206,605 | |
Total lease payments | 319,376 | |
Less: | ||
Imputed interest | (88,310) | |
Future tenant improvement reimbursements | (23,237) | |
Operating lease liabilities | $ 207,829 | $ 56,409 |