Cover Page
Cover Page - shares | 6 Months Ended | |
Jun. 30, 2022 | Jul. 25, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2022 | |
Document Transition Report | false | |
Entity File Number | 0-32405 | |
Entity Registrant Name | SEAGEN INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 91-1874389 | |
Entity Address | 21823 30th Drive SE | |
Entity Address, City or Town | Bothell | |
Entity Address, State or Province | WA | |
Postal Zip Code | 98021 | |
City Area Code | 425 | |
Local Phone Number | 527-4000 | |
Title of 12(b) Security | Common Stock, par value $0.001 | |
Trading Symbol | SGEN | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 184,435,456 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q2 | |
Entity Central Index Key | 0001060736 | |
Current Fiscal Year End Date | --12-31 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 364,874 | $ 424,834 |
Short-term investments | 1,485,448 | 1,735,202 |
Accounts receivable, net | 438,041 | 389,256 |
Inventories | 319,354 | 200,663 |
Prepaid expenses and other current assets | 170,938 | 119,239 |
Total current assets | 2,778,655 | 2,869,194 |
Property and equipment, net | 218,901 | 210,073 |
Operating lease right-of-use assets | 51,942 | 57,889 |
Intangible assets, net | 249,149 | 260,593 |
Goodwill | 274,671 | 274,671 |
Other non-current assets | 57,025 | 47,184 |
Total assets | 3,630,343 | 3,719,604 |
Current liabilities: | ||
Accounts payable | 128,872 | 114,824 |
Accrued liabilities and other | 479,649 | 454,030 |
Total current liabilities | 608,521 | 568,854 |
Long-term liabilities: | ||
Operating lease liabilities, long-term | 50,205 | 56,665 |
Other long-term liabilities | 38,805 | 28,946 |
Total long-term liabilities | 89,010 | 85,611 |
Commitments and contingencies | ||
Stockholders’ equity: | ||
Preferred stock, $0.001 par value, 5,000 shares authorized; none issued | 0 | 0 |
Common stock, $0.001 par value, 250,000 shares authorized; 184,369 shares issued and outstanding at June 30, 2022 and 183,381 shares issued and outstanding at December 31, 2021 | 184 | 183 |
Additional paid-in capital | 4,747,481 | 4,607,816 |
Accumulated other comprehensive income | 507 | 1,179 |
Accumulated deficit | (1,815,360) | (1,544,039) |
Total stockholders’ equity | 2,932,812 | 3,065,139 |
Total liabilities and stockholders’ equity | $ 3,630,343 | $ 3,719,604 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (in shares) | 5,000,000 | 5,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 250,000,000 | 250,000,000 |
Common stock, shares issued (in shares) | 184,369,000 | 183,381,000 |
Common stock, shares outstanding (in shares) | 184,369,000 | 183,381,000 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Comprehensive Loss - USD ($) shares in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Revenues: | ||||
Total revenues | $ 497,502,000 | $ 388,478,000 | $ 923,962,000 | $ 720,460,000 |
Costs and expenses: | ||||
Cost of sales | 106,100,000 | 78,090,000 | 193,726,000 | 142,225,000 |
Research and development | 304,254,000 | 234,861,000 | 601,913,000 | 465,286,000 |
Selling, general and administrative | 220,259,000 | 165,130,000 | 394,484,000 | 324,972,000 |
Total costs and expenses | 630,613,000 | 478,081,000 | 1,190,123,000 | 932,483,000 |
Loss from operations | (133,111,000) | (89,603,000) | (266,161,000) | (212,023,000) |
Investment and other (loss) income , net | (1,609,000) | 5,027,000 | (3,799,000) | 6,027,000 |
Loss before income taxes | (134,720,000) | (84,576,000) | (269,960,000) | (205,996,000) |
Provision for income taxes | 107,000 | 0 | 1,361,000 | 0 |
Net loss | $ (134,827,000) | $ (84,576,000) | $ (271,321,000) | $ (205,996,000) |
Net loss per share - basic (in dollars per share) | $ (0.73) | $ (0.47) | $ (1.48) | $ (1.14) |
Net loss per share - diluted (in dollars per share) | $ (0.73) | $ (0.47) | $ (1.48) | $ (1.14) |
Shares used in computation of per share amounts - basic (in shares) | 184,145 | 181,628 | 183,897 | 181,390 |
Shares used in computation of per share amounts - diluted (in shares) | 184,145 | 181,628 | 183,897 | 181,390 |
Comprehensive loss: | ||||
Net loss | $ (134,827,000) | $ (84,576,000) | $ (271,321,000) | $ (205,996,000) |
Other comprehensive income (loss): | ||||
Unrealized loss on securities available-for-sale, net of tax | (2,736,000) | (213,000) | (3,597,000) | (47,000) |
Foreign currency translation gain | 2,819,000 | 511,000 | 2,925,000 | 274,000 |
Total other comprehensive income (loss) | 83,000 | 298,000 | (672,000) | 227,000 |
Comprehensive loss | (134,744,000) | (84,278,000) | (271,993,000) | (205,769,000) |
Net product sales | ||||
Revenues: | ||||
Total revenues | 431,714,000 | 347,338,000 | 814,800,000 | 649,926,000 |
Royalty revenues | ||||
Revenues: | ||||
Total revenues | 39,109,000 | 36,296,000 | 67,290,000 | 63,514,000 |
Collaboration and license agreement revenues | ||||
Revenues: | ||||
Total revenues | $ 26,679,000 | $ 4,844,000 | $ 41,872,000 | $ 7,020,000 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity - USD ($) shares in Thousands, $ in Thousands | Total | Common stock | Additional paid-in capital | Accumulated other comprehensive income | Accumulated deficit |
Beginning (in shares) at Dec. 31, 2020 | 180,902 | ||||
Beginning at Dec. 31, 2020 | $ 3,488,100 | $ 181 | $ 4,356,922 | $ 565 | $ (869,568) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (121,420) | (121,420) | |||
Other comprehensive (loss) income | (71) | (71) | |||
Issuance of common stock for stock option exercises and employee stock purchase plan (in shares) | 341 | ||||
Issuance of common stock for stock option exercises and employee stock purchase plan | 19,791 | 19,791 | |||
Restricted stock vested during the period, net (in shares) | 80 | ||||
Share-based compensation | 38,224 | 38,224 | |||
Ending (in shares) at Mar. 31, 2021 | 181,323 | ||||
Ending at Mar. 31, 2021 | 3,424,624 | $ 181 | 4,414,937 | 494 | (990,988) |
Beginning (in shares) at Dec. 31, 2020 | 180,902 | ||||
Beginning at Dec. 31, 2020 | 3,488,100 | $ 181 | 4,356,922 | 565 | (869,568) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (205,996) | ||||
Other comprehensive (loss) income | 227 | ||||
Ending (in shares) at Jun. 30, 2021 | 181,866 | ||||
Ending at Jun. 30, 2021 | 3,391,274 | $ 182 | 4,465,864 | 792 | (1,075,564) |
Beginning (in shares) at Mar. 31, 2021 | 181,323 | ||||
Beginning at Mar. 31, 2021 | 3,424,624 | $ 181 | 4,414,937 | 494 | (990,988) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (84,576) | (84,576) | |||
Other comprehensive (loss) income | 298 | 298 | |||
Issuance of common stock for stock option exercises and employee stock purchase plan (in shares) | 359 | ||||
Issuance of common stock for stock option exercises and employee stock purchase plan | 13,201 | $ 1 | 13,200 | ||
Restricted stock vested during the period, net (in shares) | 184 | ||||
Share-based compensation | 37,727 | 37,727 | |||
Ending (in shares) at Jun. 30, 2021 | 181,866 | ||||
Ending at Jun. 30, 2021 | $ 3,391,274 | $ 182 | 4,465,864 | 792 | (1,075,564) |
Beginning (in shares) at Dec. 31, 2021 | 183,381 | 183,381 | |||
Beginning at Dec. 31, 2021 | $ 3,065,139 | $ 183 | 4,607,816 | 1,179 | (1,544,039) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (136,494) | (136,494) | |||
Other comprehensive (loss) income | (755) | (755) | |||
Issuance of common stock for stock option exercises and employee stock purchase plan (in shares) | 463 | ||||
Issuance of common stock for stock option exercises and employee stock purchase plan | 26,664 | $ 1 | 26,663 | ||
Restricted stock vested during the period, net (in shares) | 48 | ||||
Share-based compensation | 43,913 | 43,913 | |||
Ending (in shares) at Mar. 31, 2022 | 183,892 | ||||
Ending at Mar. 31, 2022 | $ 2,998,467 | $ 184 | 4,678,392 | 424 | (1,680,533) |
Beginning (in shares) at Dec. 31, 2021 | 183,381 | 183,381 | |||
Beginning at Dec. 31, 2021 | $ 3,065,139 | $ 183 | 4,607,816 | 1,179 | (1,544,039) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (271,321) | ||||
Other comprehensive (loss) income | $ (672) | ||||
Ending (in shares) at Jun. 30, 2022 | 184,369 | 184,369 | |||
Ending at Jun. 30, 2022 | $ 2,932,812 | $ 184 | 4,747,481 | 507 | (1,815,360) |
Beginning (in shares) at Mar. 31, 2022 | 183,892 | ||||
Beginning at Mar. 31, 2022 | 2,998,467 | $ 184 | 4,678,392 | 424 | (1,680,533) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (134,827) | (134,827) | |||
Other comprehensive (loss) income | 83 | 83 | |||
Issuance of common stock for stock option exercises and employee stock purchase plan (in shares) | 298 | ||||
Issuance of common stock for stock option exercises and employee stock purchase plan | 14,960 | 14,960 | |||
Restricted stock vested during the period, net (in shares) | 179 | ||||
Share-based compensation | $ 54,129 | 54,129 | |||
Ending (in shares) at Jun. 30, 2022 | 184,369 | 184,369 | |||
Ending at Jun. 30, 2022 | $ 2,932,812 | $ 184 | $ 4,747,481 | $ 507 | $ (1,815,360) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Operating activities: | ||
Net loss | $ (271,321) | $ (205,996) |
Adjustments to reconcile net loss to net cash used by operating activities | ||
Share-based compensation | 98,042 | 75,951 |
Depreciation | 22,867 | 19,603 |
Amortization of intangible assets | 11,444 | 11,451 |
Amortization of right-of-use assets | 6,140 | 6,356 |
Amortization of premiums, accretion of discounts, and (gains) losses on debt securities | 484 | 11,802 |
Losses (gains) on equity securities | 7,078 | (4,929) |
Deferred income taxes | (557) | 0 |
Changes in operating assets and liabilities | ||
Accounts receivable, net | (48,785) | (54,752) |
Inventories | (118,691) | (47,048) |
Prepaid expenses and other assets | (37,249) | (46,122) |
Lease liability | (8,533) | (7,481) |
Other liabilities | 50,499 | 43,395 |
Net cash used by operating activities | (288,582) | (197,770) |
Investing activities: | ||
Purchases of securities | (1,489,327) | (1,788,967) |
Proceeds from maturities of securities | 1,735,000 | 1,831,500 |
Payments for lessor-owned assets | (13,756) | 0 |
Purchases of property and equipment | (32,161) | (22,403) |
Net cash provided by investing activities | 199,756 | 20,130 |
Financing activities: | ||
Proceeds from exercise of stock options and employee stock purchase plan | 41,624 | 32,992 |
Net cash provided by financing activities | 41,624 | 32,992 |
Effect of exchange rate changes on cash, cash equivalents, and restricted cash | (2,809) | (342) |
Net decrease in cash, cash equivalents, and restricted cash | (50,011) | (144,990) |
Cash, cash equivalents, and restricted cash at beginning of period | 424,834 | 558,424 |
Cash, cash equivalents, and restricted cash at end of period | $ 374,823 | $ 413,434 |
Summary of significant accounti
Summary of significant accounting policies | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Policies [Abstract] | |
Summary of significant accounting policies | Summary of significant accounting policies Basis of presentation The accompanying unaudited condensed consolidated financial statements reflect the accounts of Seagen Inc. and its wholly-owned subsidiaries (collectively “Seagen,” “we,” “our,” or “us”). All intercompany transactions and balances have been eliminated. Management has determined that we operate in one segment: the development and sale of pharmaceutical products on our own behalf or in collaboration with others. Substantially all of our assets and revenues are related to operations in the U.S.; however, we have multiple subsidiaries in foreign jurisdictions, including several subsidiaries in Europe. The condensed consolidated balance sheet data as of December 31, 2021 were derived from audited financial statements not included in this quarterly report on Form 10-Q. The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with the rules and regulations of the Securities and Exchange Commission, or SEC, and generally accepted accounting principles in the United States of America, or GAAP, for unaudited condensed consolidated financial information. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. The accompanying unaudited condensed consolidated financial statements reflect all adjustments consisting of normal recurring adjustments that, in the opinion of management, are necessary for a fair statement of our financial position and results of our operations as of and for the periods presented. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and accompanying notes included in our Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the SEC. The preparation of financial statements in accordance with GAAP requires us to make estimates, assumptions, and judgments that affect the amounts reported in the condensed consolidated financial statements and accompanying notes. Actual results could differ from those estimates. The results of our operations for the three and six month period ended June 30, 2022 are not necessarily indicative of the results to be expected for the full year or any other interim period. Non-cash activities We had $9.4 million and $9.9 million of accrued capital expenditures as of June 30, 2022 and December 31, 2021, respectively. Accrued capital expenditures are treated as a non-cash investing activity and, accordingly, have not been included in the condensed consolidated statement of cash flows until such amounts have been paid in cash. Investments We hold certain equity securities which are reported at estimated fai r value based on quoted market prices. Cha nges in the fair value of equity securities are recorded in income or loss. The cost of equity securities for purposes of computing gains and losses is based on the specific identification method. We invest our available cash primarily in debt securities. These debt securities are classified as available-for-sale, which are reported at estimated fair value with unrealized gains and losses included in accumulated other comprehensive income (loss) in stockholders’ equity. Realized gains, realized losses and declines in the value of debt securities judged to be other-than-temporary are included in investment and other income (loss), net. The cost of debt securities for purposes of computing realized and unrealized gains and losses is based on the specific identification method. Amortization of premiums and accretion of discounts on debt securities are included in investment and other income (loss), net. Interest and dividends earned are included in investment and other income (loss), net . Accrued interest receivable as of June 30, 2022 and December 31, 2021 , were $2.2 million and $0.4 million, respectively, and were included in prepaid expenses and other current assets. We c lassify investments in debt securities maturing within one year of the reporting date, or where management’s intent is to use the investments to fund current operations or to make them available for current operations, as short-term investments. If the estimated fair value of a debt security is below its carrying value, we evaluate whether it is more likely than not that we will sell the security before its anticipated recovery in market value and whether evidence indicating that the cost of the investment is recoverable within a reasonable period of time outweighs evidence to the contrary. We also evaluate whether or not we intend to sell the investment. If the impairment is considered to be other-than-temporary, the security is written down to its estimated fair value. In addition, we consider whether credit losses exist for any securities. A credit loss exists if the present value of cash flows expected to be collected is less than the amortized cost basis of the security. Other-than-temporary declines in estimated fair value and credit losses are included in investment and other income (loss), net. Restricted Cash As of June 30, 2022, we had $9.9 million cash held in escrow restricted by a contractual agreement related to our Everett, Washington building construction project. The restricted cash was recorded in prepaid expenses and other current assets in the condensed consolidated balance sheet. We determine classification based on the expected duration of the restriction. Our total cash, cash equivalents, and restricted cash, as presented in the condensed consolidated statements of cash flows, was as follows: (dollars in thousands) June 30, 2022 December 31, 2021 June 30, 2021 December 31, 2020 Cash and cash equivalents $ 364,874 $ 424,834 $ 413,434 $ 558,424 Restricted cash included in prepaid expenses and other current assets 9,949 — — — Total cash, cash equivalents, and restricted cash as presented in the condensed consolidated statements of cash flows $ 374,823 $ 424,834 $ 413,434 $ 558,424 Intangible assets, net Our intangible assets are primarily comprised of acquired TUKYSA technology. The following table presents the balances of our finite-lived intangible assets for the periods presented: (dollars in thousands) June 30, 2022 December 31, 2021 Gross carrying value $ 305,650 $ 305,650 Less: accumulated amortization (56,501) (45,057) Total $ 249,149 $ 260,593 The following table presents our amortization expense related to acquired TUKYSA technology costs, included in cost of sales in our condensed consolidated statements of comprehensive loss, for the periods presented: Three Months Ended June 30, Six Months Ended June 30, (dollars in thousands) 2022 2021 2022 2021 Amortization expense $ 5,753 $ 5,757 $ 11,444 $ 11,451 The weighted average remaining useful life of our finite-lived intangible assets was approximately 11 years as of June 30, 2022, and estimated future amortization expense related to acquired TUKYSA is $11.6 million for the six months ending December 31, 2022, and TUKYSA technology costs is $23.1 million for each of the years ending December 31, 2023 through December 31, 2027. Revenue recognition - Net product sales We sell our products primarily through a limited number of specialty distributors and specialty pharmaci es in the U.S, and to a lesser extent, internationally. The delivery of our products represents a single performance obligation for these transactions and we record net product sales at the point in time when control is transferred to the customer, which generally occurs upon receipt by the customer. The transaction price for net product sales represents the amount we expect to receive, which is net of estimated government-mandated rebates and chargebacks, distribution fees, estimated product returns, and other deductions. Accruals are established for these deductions, and actual amounts incurred are offset against applicable accruals. We reflect these accruals as either a reduction in the related account receivable from the distributor or as an accrued liability, depending on the nature of the sales deduction. Sales deductions are based on management’s estimates that consider payor mix in target markets and experience to-date. These estimates involve a substantial degree of judgment. Outside of the U.S., the transaction price for net product sales represents the amount we expect to receive, which is net of estimated discounts, estimated government mandated rebates, distribution fees, estimated product returns, and other deductions. Accruals are established for these deductions, and actual amounts incurred are offset against applicable accruals. These estimates involve judgment in estimating net product sales. U.S. government-mandated rebates and chargebacks: We have entered into a Medicaid Drug Rebate Agreement, or MDRA, with the Centers for Medicare & Medicaid Services. This agreement provides for a rebate based on covered purchases of our products. Medicaid rebates are invoiced to us by the various state Medicaid programs. We estimate Medicaid rebates using the expected value approach, based on a variety of factors, including payor mix and our experience to-date. We have a Federal Supply Schedule, or FSS, agreement under which certain U.S. government purchasers receive a discount on eligible purchases of our products. In addition, we have entered into a Pharmaceutical Pricing Agreement with the Secretary of Health and Human Services, which enables certain entities that qualify for government pricing under the Public Health Services Act, or PHS, to receive discounts on their qualified purchases of our products. Under these agreements, eligible customers receive an applicable discount which is processed through the distributor as a chargeback. We estimate expected chargebacks for FSS and PHS purchases based on the expected value of each entity’s eligibility for the FSS and PHS programs. We also review historical rebate and chargeback information to further refine these estimates. Distribution fees, product returns and other deductions: Our distributors charge a volume-based fee for distribution services that they perform for us. We allow for the return of product that is within a specified number of days of its expiration date or that is damaged. We estimate product returns based on our experience to-date using the expected value approach. We provide financial assistance to qualifying patients that are underinsured or cannot cover the cost of commercial coinsurance amounts through our patient support programs. Estimated contributions for commercial coinsurance under Seagen Secure are deducted from gross sales and are based on an analysis of expected plan utilization. These estimates are adjusted as necessary to reflect our actual experience. Revenue recognition - Royalty revenues Royalty revenues primarily reflect amounts earned under the ADCETRIS collaboration with Takeda Pharmaceutical Company Limited, or Takeda. These royalties include commercial sales-based milestones and sales royalties that relate predominantly to the license of intellectual property. Sales royalties are based on a percentage of Takeda’s net sales of ADCETRIS, with rates that range from the mid-teens to the mid-twenties based on annual net sales tiers. Takeda bears a portion of low single digit third-party royalty costs owed on its sales of ADCETRIS. This amount is included in royalty revenues. Amounts owed to our third-party licensors related to Takeda’s sales of ADCETRIS are recorded in cost of sales. These amounts are recognized in the period in which the related sales by Takeda occur. Royalty revenues also reflect amounts from Genentech, Inc., a member of the Roche Group, or Genentech, earned on net sales of Polivy, and amounts from GlaxoSmithKline earned on net sales of Blenrep. Revenue recognition - Collaboration and license agreement revenues We have collaboration and license agreements for our technology with a number of biotechnology and pharmaceutical companies. Under these agreements, we typically receive or are entitled to receive upfront cash payments and progress- and sales-dependent milestones for the achievement by our licensees of certain events, and annual maintenance fees and support fees for research and development services and materials provided under the agreements. We also are entitled to receive royalties on net sales of any resulting products incorporating our technology. Generally, our licensees are solely responsible for research, product development, manufacturing and commercialization of any product candidates under these collaborations, which includes the achievement of the potential milestones. Since we may not take a substantive role or control the research, development or commercialization of any products generated by some of our licensees, we may not be able to reasonably estimate when, if at all, any potential future milestone payments or royalties may be payable to us by our licensees. As such, the potential future milestone payments associated with certain of our collaboration and license agreements involve a substantial degree of uncertainty and risk that they may never be received . Collaboration and license agreements are initially evaluated as to whether the intellectual property licenses granted by us represent distinct performance obligations. If they are determined to be distinct, the value of the intellectual property licenses would be recognized up-front while the research and development service fees would be recognized as the performance obligations are satisfied. Variable consideration is assessed at each reporting period as to whether it is not subject to future reversal of cumulative revenue and, therefore, should be included in the transaction price. Assessing the recognition of variable consideration requires significant judgment. If a contract includes a fixed or minimum amount of research and development support, this also would be included in the transaction price. Changes to collaboration and license agreements, such as the extensions of the research term or increasing the number of targets or technology covered under an existing agreement, are assessed for whether they represent a modification or should be accounted for as a new contract. We have concluded that the license of intellectual property in certain collaboration and license agreements is not distinct from the perspective of our customers at the time of initial transfer, since we often do not license intellectual property without related technology transfer and research and development support services. Such evaluation requires significant judgment since it is made from the customer's perspective. Our performance obligations under our collaborations may include such things as providing intellectual property licenses, performing technology transfer, performing research and development consulting services, providing reagents, ADCs, and other materials, and notifying the customer of any enhancements to licensed technology or new technology that we discover, among others. We determined our performance obligations under certain collaboration and license agreements as evaluated at contract inception were not distinct and represented a single performance obligation. Upfront payments are amortized to revenue over the performance period. Upfront payment contract liabilities resulting from our collaborations do not represent a financing component as the payment is not financing the transfer of goods or services, and the technology underlying the licenses granted reflects research and development expenses already incurred by us. For agreements beyond the initial performance period, we have no remaining performance obligations. We may receive license maintenance fees and potential milestones and royalties based on collaborator development and regulatory progress, which are recorded in the period achieved in the case of milestones, and during the period of the related sales for royalties. When no performance obligations are required of us, or following the completion of the performance obligation period, such amounts are recognized upon transfer of control of the goods or services to the customer. Generally, all amounts received or due other than sales-based milestones and royalties are classified as collaboration and license agreement revenues. Sales-based milestones and royalties are recognized as royalty revenue in the period the related sale occurred. We generally invoice our collaborators and licensees on a monthly or quarterly basis, or upon the completion of the effort or achievement of a milestone, based on the terms of each agreement. Deferred revenue arises from amounts received in advance of the culmination of the earnings process and is recognized as revenue in future periods as performance obligations are satisfied. Deferred revenue expected to be recognized within the next twelve months is classified as a current liability. |
Revenue from contracts with cus
Revenue from contracts with customers | 6 Months Ended |
Jun. 30, 2022 | |
Revenue from Contract with Customer [Abstract] | |
Revenue from contracts with customers | Revenue from contracts with customers The following table presents our disaggregated revenue for the periods presented. Three Months Ended June 30, Six Months Ended June 30, (dollars in thousands) 2022 2021 2022 2021 ADCETRIS $ 201,939 $ 181,912 $ 382,928 $ 344,484 PADCEV 123,577 82,405 223,784 152,163 TUKYSA 88,989 83,021 179,464 153,279 TIVDAK 17,209 — 28,624 — Net product sales $ 431,714 $ 347,338 $ 814,800 $ 649,926 Royalty revenues $ 39,109 $ 36,296 $ 67,290 $ 63,514 Collaboration and license agreement revenues $ 26,679 $ 4,844 $ 41,872 $ 7,020 Total revenues $ 497,502 $ 388,478 $ 923,962 $ 720,460 |
Leases
Leases | 6 Months Ended |
Jun. 30, 2022 | |
Leases [Abstract] | |
Leases | Leases We have operating leases for our office and laboratory facilities with terms that expire from 2022 through 2029. We recorded $0.2 million and $7.1 million right-of-use assets in exchange for lease liabilities, respectively, during the six months ended June 30, 2022 and 2021, respectively. All of our significan t leases include options for us to extend the lease term. None of our options to extend the rental term of any existing leases were considered reasonably certain as of June 30, 2022. In June 2021, we entered into a lease agreement for an approximately 258,000 square feet building complex to be constructed by the landlord on approximately 20.5 acres of land in Everett, Washington. We intend to use the building for future manufacturing, laboratory, and office space. Under the terms of the lease, base rent is payable at an initial rate of $4.0 million per year, subject to annual escalations of 3% during the initial term of 20 years. The lease commences on the date when construction and delivery of the building shell and related improvements by the landlord have been substantially completed. We will record a lease liability and right-of-use assets on our condensed consolidated balance sheet on the lease commencement date, which has not commenced as of June 30, 2022 . We have an option to renew the lease for two additional terms of ten years each. In addition, we have an option to purchase the premises in the future. Supplemental operating lease information was as follows: Three Months Ended June 30, Six Months Ended June 30, (dollars in thousands) 2022 2021 2022 2021 Operating lease cost $ 3,947 $ 4,063 $ 8,142 $ 8,077 Variable lease cost 1,249 1,151 2,321 2,138 Total lease cost $ 5,196 $ 5,214 $ 10,463 $ 10,215 Cash paid for amounts included in measurement of lease liabilities $ 4,196 $ 4,199 $ 8,749 $ 8,057 As of June 30, 2022 2021 Weighted average remaining lease term 5.6 years 6.3 years Weighted average discount rate 5 % 5.1 % Operating lease liabilities were recorded in the following captions of our condensed consolidated balance sheet as follows: (dollars in thousands) June 30, 2022 December 31, 2021 Accrued liabilities and other $ 13,700 $ 13,905 Operating lease liabilities, long-term 50,205 56,665 Total $ 63,905 $ 70,570 |
Net loss per share
Net loss per share | 6 Months Ended |
Jun. 30, 2022 | |
Earnings Per Share [Abstract] | |
Net loss per share | Net loss per share Basic net loss per share is computed by dividing net loss by the weighted average number of common shares outstanding during the period. Diluted net loss per share is computed by dividing net loss by the weighted average number of common shares and dilutive potential common shares outstanding during the period. Potentially dilutive common shares include incremental common shares issuable upon the vesting of unvested restricted stock units and the exercise of outstanding stock options, calculated using the treasury stock method. We excluded the potential shares of common stock from the computation of diluted net loss per share because their effect would have been antidilutive. The following table presents the weighted average number of shares that have been excluded for all periods presented: Three Months Ended June 30, Six Months Ended June 30, (in thousands) 2022 2021 2022 2021 Stock options and RSUs 9,824 9,992 10,077 10,229 |
Fair value
Fair value | 6 Months Ended |
Jun. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair value | Fair value We have certain assets that are measured at fair value on a recurring basis according to a fair value hierarchy that prioritizes the inputs, assumptions and valuation techniques used to measure fair value. The three levels of the fair value hierarchy are: Level 1: Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities. Level 2: Quoted prices in markets that are not active or financial instruments for which all significant inputs are observable, either directly or indirectly. Level 3: Prices or valuations that require inputs that are both significant to the fair value measurement and unobservable. The determination of a financial instrument’s level within the fair value hierarchy is based on an assessment of the lowest level of any input that is significant to the fair value measurement. We consider observable data to be market data which is readily available, regularly distributed or updated, reliable and verifiable, not proprietary, and provided by independent sources that are actively involved in the relevant market. The fair value hierarchy of assets carried at fair value and measured on a recurring basis was as follows: Fair value measurement using: (dollars in thousands) Quoted prices Other Significant Total June 30, 2022 Short-term investments—U.S. Treasury securities $ 1,485,448 $ — $ — $ 1,485,448 Other non-current assets—equity securities 6,931 — — 6,931 Total $ 1,492,379 $ — $ — $ 1,492,379 December 31, 2021 Short-term investments—U.S. Treasury securities $ 1,735,202 $ — $ — $ 1,735,202 Other non-current assets—equity securities 14,009 — — 14,009 Total $ 1,749,211 $ — $ — $ 1,749,211 Our short-term debt investments portfolio only contains investments in U.S. Treasury and other U.S. government-backed securities. We review our portfolio based on the underlying risk profile of the securities and have a zero loss expectation for these investments. We also regularly review the securities in an unrealized loss position and evaluate the current expected credit loss by considering factors such as historical experience, market data, issuer-specific factors, and current economic conditions. During the three and six months ended June 30, 2022 and 2021, we recognized no year-to-date credit loss related to our short- and long-term investments, and had no allowance for credit loss recorded as of June 30, 2022 or December 31, 2021. Our debt securities consisted of the following: (dollars in thousands) Amortized Gross Gross Fair June 30, 2022 U.S. Treasury securities $ 1,489,231 $ 30 $ (3,813) $ 1,485,448 Contractual maturities (at date of purchase): Due in one year or less $ 1,473,502 $ 1,469,688 Due in one to two years 15,729 15,760 Total $ 1,489,231 $ 1,485,448 December 31, 2021 U.S. Treasury securities $ 1,735,388 $ 12 $ (198) $ 1,735,202 Contractual maturities (at date of purchase): Due in one year or less $ 1,635,307 $ 1,635,118 Due in one to two years 100,081 100,084 Total $ 1,735,388 $ 1,735,202 |
Investment and other income (lo
Investment and other income (loss), net | 6 Months Ended |
Jun. 30, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Investment and other income (loss), net | Investment and other income (loss), net Investment and other income (loss), net consisted of the following: Three Months Ended June 30, Six Months Ended June 30, (dollars in thousands) 2022 2021 2022 2021 (Loss) gain on equity securities $ (4,299) $ 4,670 $ (7,078) $ 4,929 Investment and other income, net 2,690 357 3,279 1,098 Total investment and other (loss) income, net $ (1,609) $ 5,027 $ (3,799) $ 6,027 (Loss) gain on equity securities includes the realized and unrealized holding gains and losses on our equity securities. At times, we hold equity investments in certain companies acquired in relation to a strategic partnership. Shares held at the end of reporting periods are marked to market in our condensed consolidated financial statements, which can result in unrealized gains and losses. |
Inventories
Inventories | 6 Months Ended |
Jun. 30, 2022 | |
Inventory Disclosure [Abstract] | |
Inventories | Inventories Inventories consisted of the following: (dollars in thousands) June 30, 2022 December 31, 2021 Raw materials $ 15,541 $ 12,181 Work in process 259,805 152,635 Finished goods 44,008 35,847 Total $ 319,354 $ 200,663 We capitalize our commercial inventory costs. Inventory that is deployed into clinical, research or development use is charged to research and development expense when it is no longer available for use in commercial sales. |
Accrued liabilities
Accrued liabilities | 6 Months Ended |
Jun. 30, 2022 | |
Payables and Accruals [Abstract] | |
Accrued liabilities | Accrued liabilities Accrued liabilities consisted of the following: (dollars in thousands) June 30, 2022 December 31, 2021 Employee compensation and benefits $ 107,585 $ 139,052 Clinical trial and related costs 169,425 122,468 Contract manufacturing 24,211 21,867 Gross-to-net deductions and third-party royalties 95,094 81,316 Other 83,334 89,327 Total $ 479,649 $ 454,030 |
Share-based compensation
Share-based compensation | 6 Months Ended |
Jun. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Share-based compensation | Share-based compensation The following table presents our total share-based compensation expense for the periods presented: Three Months Ended June 30, Six Months Ended June 30, (dollars in thousands) 2022 2021 2022 2021 Research and development $ 23,446 $ 17,232 $ 46,522 $ 34,196 Selling, general and administrative 30,683 20,495 51,520 41,755 Total share-based compensation expense $ 54,129 $ 37,727 $ 98,042 $ 75,951 As of June 30, 2022 , there was $105.7 million of unrecognized compensation cost related to unvested options and restricted stock unit awards, excluding our LTIPs and performance-based awards, net of forfeitures. T he estimated unrecognized compensation expense related to our performance-based LTIPs was approximately $71 million as of June 30, 2022 . On May 15, 2022, we entered into a separation agreement with our former CEO which modified certain terms of his previously granted equity awards. The agreement provided for the following equity considerations: acceleration of his outstanding and unvested restricted stock unit and stock option awards by an additional 18 months following his separation; the exercisability of his vested options would be extended to December 31, 2023 (or, if earlier, their 10-year expiration); and 5/6 of his outstanding and unvested restricted stock units subject to performance-based vesting conditions granted in 2019 remain eligible to vest on March 13, 2023, based on actual performance through December 31, 2022. Accounting for the equity awards impacted by the separation agreement resulted in $7.3 million of share-based compensation expense recorded in the quarter ended June 30, 2022, net of forfeitures for equity awards that will not vest, other than in the event that a change of control occurs on or prior to December 31, 2023. |
Income taxes
Income taxes | 6 Months Ended |
Jun. 30, 2022 | |
Income Tax Disclosure [Abstract] | |
Income taxes | Income taxes For the three and six months ended June 30, 2022, we had taxable profits in the U.S. as a result of amendments to IRC Section 174, which took effect January 1, 2022 pursuant to the 2017 Tax Cuts and Jobs Act. We recorded an income tax provision for the three and six months ended June 30, 2022 of $0.1 million and $1.4 million, respectively, primarily related to estimated state tax liabilities for which there were limitations on the use of existing state tax carryforwards. We had existing federal tax carryforwards sufficient to offset any federal liability. Our income tax provision also reflected taxable profits in foreign jurisdictions partially offset by a foreign valuation allowance release. Our effective tax rate for the three and six months ended June 30, 2022 of approximately 0.1% and 0.5%, respectively, differed from the federal statutory rate primarily because we have provided a valuation allowance against substantially all our deferred tax assets. For the three and six months ended June 30, 2021, we did not record any income tax provision. |
Legal matters
Legal matters | 6 Months Ended |
Jun. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Legal matters | Legal matters We are engaged in multiple legal disputes with Daiichi Sankyo Co. Ltd., or Daiichi Sankyo. Dispute over ownership of intellectual property We are in a dispute with Daiichi Sankyo regarding the ownership of certain technology used by Daiichi Sankyo in its cancer drug ENHERTU® (fam-trastuzumab deruxtecan-nxki) and certain product candidates. We believe that the linker and other ADC technology used in ENHERTU and these drug candidates are improvements to our ADC technology, the ownership of which we contend was assigned to us under the terms of a 2008 collaboration agreement between us and Daiichi Sankyo. On November 12, 2019, we submitted an arbitration demand to the American Arbitration Association seeking, among other remedies, a declaration that we are the owner of the intellectual property rights under dispute, monetary damages, and a running royalty. On April 27, 2020, the arbitrator confirmed the dispute should be resolved in arbitration. The arbitration hearing was conducted in June 2021. Recently, the arbitration hearing record was reopened by the arbitrator to consider additional evidence. A decision in the arbitration case is expected in mid-2022. On November 4, 2019, Daiichi Sankyo filed a declaratory judgment action in the United States District Court for the District of Delaware, alleging that we are not entitled to the intellectual property rights under dispute, in an attempt to have the dispute adjudicated in federal court. The case has been stayed and administratively closed by court order. Patent infringement On October 19, 2020, we filed a complaint in the United States District Court for the Eastern District of Texas to commence an action for infringement of our U.S. Patent No. 10,808,039, or the '039 Patent, by Daiichi Sankyo’s importation into, offer for sale, sale, and use in the United States of the cancer drug ENHERTU. The remedies sought in this action include, among other remedies, a judgment that Daiichi Sankyo infringed one or more valid and enforceable claims of the '039 Patent, monetary damages and a running royalty. Daiichi Sankyo (as well as Daiichi Sankyo, Inc. and AstraZeneca Pharmaceuticals, LP, or AstraZeneca) subsequently filed an action on November 13, 2020 in the U.S. District Court for the District of Delaware seeking a declaratory judgment that ENHERTU does not infringe the ‘039 Patent. The Delaware action has been stayed by court order. Daiichi Sankyo, Inc. and AstraZeneca also filed two petitions for post-grant review on December 23, 2020 and January 22, 2021 with the U.S. Patent and Trademark Office, or USPTO, seeking to have claims of the ‘039 Patent cancelled as unpatentable. On June 24, 2021, the USPTO issued a decision denying both petitions for post-grant review. On April 7, 2022, the USPTO granted a request on rehearing and instituted two post-grant review proceedings, but on July 15, 2022, the USPTO issued a new decision denying post-grant review of the claims asserted in the patent infringement action. On April 8, 2022, a jury in the United States District Court for the Eastern District of Texas found that Daiichi Sankyo willfully infringed the asserted claims of the '039 Patent with its ENHERTU product, and also found that the asserted claims were not invalid. The jury further awarded damages of $41.8 million for infringement from October 20, 2020 through March 31, 2022. The U.S. District Court for the Eastern District of Texas also denied Daiichi Sankyo’s claim that the ‘039 Patent should be unenforceable under the equitable theory of prosecution laches, entered judgment in favor of Seagen based on the jury’s verdict that Daiichi Sankyo willfully infringed the ‘039 Patent consisting of pre-trial damages in the sum of $41.8 million, and awarded Seagen pre- and post-trial interest and costs. We will record an amount of awarded damages in our condensed consolidated financial statements when we have determined the payment to be realized or realizable under ASC 450. We intend to request a royalty on Daiichi Sankyo's future sales of ENHERTU in the United States through November 5, 2024. |
Summary of significant accoun_2
Summary of significant accounting policies (Policies) | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Policies [Abstract] | |
Basis of presentation | Basis of presentation The accompanying unaudited condensed consolidated financial statements reflect the accounts of Seagen Inc. and its wholly-owned subsidiaries (collectively “Seagen,” “we,” “our,” or “us”). All intercompany transactions and balances have been eliminated. Management has determined that we operate in one segment: the development and sale of pharmaceutical products on our own behalf or in collaboration with others. Substantially all of our assets and revenues are related to operations in the U.S.; however, we have multiple subsidiaries in foreign jurisdictions, including several subsidiaries in Europe. The condensed consolidated balance sheet data as of December 31, 2021 were derived from audited financial statements not included in this quarterly report on Form 10-Q. The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with the rules and regulations of the Securities and Exchange Commission, or SEC, and generally accepted accounting principles in the United States of America, or GAAP, for unaudited condensed consolidated financial information. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. The accompanying unaudited condensed consolidated financial statements reflect all adjustments consisting of normal recurring adjustments that, in the opinion of management, are necessary for a fair statement of our financial position and results of our operations as of and for the periods presented. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and accompanying notes included in our Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the SEC. The preparation of financial statements in accordance with GAAP requires us to make estimates, assumptions, and judgments that affect the amounts reported in the condensed consolidated financial statements and accompanying notes. Actual results could differ from those estimates. The results of our operations for the three and six month period ended June 30, 2022 are not necessarily indicative of the results to be expected for the full year or any other interim period. |
Non-cash activities | Non-cash activities We had $9.4 million |
Investments | Investments We hold certain equity securities which are reported at estimated fai r value based on quoted market prices. Cha nges in the fair value of equity securities are recorded in income or loss. The cost of equity securities for purposes of computing gains and losses is based on the specific identification method. We invest our available cash primarily in debt securities. These debt securities are classified as available-for-sale, which are reported at estimated fair value with unrealized gains and losses included in accumulated other comprehensive income (loss) in stockholders’ equity. Realized gains, realized losses and declines in the value of debt securities judged to be other-than-temporary are included in investment and other income (loss), net. The cost of debt securities for purposes of computing realized and unrealized gains and losses is based on the specific identification method. Amortization of premiums and accretion of discounts on debt securities are included in investment and other income (loss), net. Interest and dividends earned are included in investment and other income (loss), net . Accrued interest receivable as of June 30, 2022 and December 31, 2021 , were $2.2 million and $0.4 million, respectively, and were included in prepaid expenses and other current assets. We c lassify investments in debt securities maturing within one year of the reporting date, or where management’s intent is to use the investments to fund current operations or to make them available for current operations, as short-term investments. If the estimated fair value of a debt security is below its carrying value, we evaluate whether it is more likely than not that we will sell the security before its anticipated recovery in market value and whether evidence indicating that the cost of the investment is recoverable within a reasonable period of time outweighs evidence to the contrary. We also evaluate whether or not we intend to sell the investment. If the impairment is considered to be other-than-temporary, the security is written down to its estimated fair value. In addition, we consider whether credit losses exist for any securities. A credit loss exists if the present value of cash flows expected to be collected is less than the amortized cost basis of the security. Other-than-temporary declines in estimated fair value and credit losses are included in investment and other income (loss), net. |
Restricted Cash | Restricted Cash As of June 30, 2022, we had $9.9 million cash held in escrow restricted by a contractual agreement related to our Everett, Washington building construction project. The restricted cash was recorded in prepaid expenses and other current assets in the condensed consolidated balance sheet. We determine classification based on the expected duration of the restriction. |
Intangible assets, net | Intangible assets, netOur intangible assets are primarily comprised of acquired TUKYSA technology. |
Revenue recognition - Net product sales | Revenue recognition - Net product sales We sell our products primarily through a limited number of specialty distributors and specialty pharmaci es in the U.S, and to a lesser extent, internationally. The delivery of our products represents a single performance obligation for these transactions and we record net product sales at the point in time when control is transferred to the customer, which generally occurs upon receipt by the customer. The transaction price for net product sales represents the amount we expect to receive, which is net of estimated government-mandated rebates and chargebacks, distribution fees, estimated product returns, and other deductions. Accruals are established for these deductions, and actual amounts incurred are offset against applicable accruals. We reflect these accruals as either a reduction in the related account receivable from the distributor or as an accrued liability, depending on the nature of the sales deduction. Sales deductions are based on management’s estimates that consider payor mix in target markets and experience to-date. These estimates involve a substantial degree of judgment. Outside of the U.S., the transaction price for net product sales represents the amount we expect to receive, which is net of estimated discounts, estimated government mandated rebates, distribution fees, estimated product returns, and other deductions. Accruals are established for these deductions, and actual amounts incurred are offset against applicable accruals. These estimates involve judgment in estimating net product sales. U.S. government-mandated rebates and chargebacks: We have entered into a Medicaid Drug Rebate Agreement, or MDRA, with the Centers for Medicare & Medicaid Services. This agreement provides for a rebate based on covered purchases of our products. Medicaid rebates are invoiced to us by the various state Medicaid programs. We estimate Medicaid rebates using the expected value approach, based on a variety of factors, including payor mix and our experience to-date. We have a Federal Supply Schedule, or FSS, agreement under which certain U.S. government purchasers receive a discount on eligible purchases of our products. In addition, we have entered into a Pharmaceutical Pricing Agreement with the Secretary of Health and Human Services, which enables certain entities that qualify for government pricing under the Public Health Services Act, or PHS, to receive discounts on their qualified purchases of our products. Under these agreements, eligible customers receive an applicable discount which is processed through the distributor as a chargeback. We estimate expected chargebacks for FSS and PHS purchases based on the expected value of each entity’s eligibility for the FSS and PHS programs. We also review historical rebate and chargeback information to further refine these estimates. Distribution fees, product returns and other deductions: Our distributors charge a volume-based fee for distribution services that they perform for us. We allow for the return of product that is within a specified number of days of its expiration date or that is damaged. We estimate product returns based on our experience to-date using the expected value approach. We provide financial assistance to qualifying patients that are underinsured or cannot cover the cost of commercial coinsurance amounts through our patient support programs. Estimated contributions for commercial coinsurance under Seagen Secure are deducted from gross sales and are based on an analysis of expected plan utilization. These estimates are adjusted as necessary to reflect our actual experience. Revenue recognition - Royalty revenues Royalty revenues primarily reflect amounts earned under the ADCETRIS collaboration with Takeda Pharmaceutical Company Limited, or Takeda. These royalties include commercial sales-based milestones and sales royalties that relate predominantly to the license of intellectual property. Sales royalties are based on a percentage of Takeda’s net sales of ADCETRIS, with rates that range from the mid-teens to the mid-twenties based on annual net sales tiers. Takeda bears a portion of low single digit third-party royalty costs owed on its sales of ADCETRIS. This amount is included in royalty revenues. Amounts owed to our third-party licensors related to Takeda’s sales of ADCETRIS are recorded in cost of sales. These amounts are recognized in the period in which the related sales by Takeda occur. Royalty revenues also reflect amounts from Genentech, Inc., a member of the Roche Group, or Genentech, earned on net sales of Polivy, and amounts from GlaxoSmithKline earned on net sales of Blenrep. Revenue recognition - Collaboration and license agreement revenues We have collaboration and license agreements for our technology with a number of biotechnology and pharmaceutical companies. Under these agreements, we typically receive or are entitled to receive upfront cash payments and progress- and sales-dependent milestones for the achievement by our licensees of certain events, and annual maintenance fees and support fees for research and development services and materials provided under the agreements. We also are entitled to receive royalties on net sales of any resulting products incorporating our technology. Generally, our licensees are solely responsible for research, product development, manufacturing and commercialization of any product candidates under these collaborations, which includes the achievement of the potential milestones. Since we may not take a substantive role or control the research, development or commercialization of any products generated by some of our licensees, we may not be able to reasonably estimate when, if at all, any potential future milestone payments or royalties may be payable to us by our licensees. As such, the potential future milestone payments associated with certain of our collaboration and license agreements involve a substantial degree of uncertainty and risk that they may never be received . Collaboration and license agreements are initially evaluated as to whether the intellectual property licenses granted by us represent distinct performance obligations. If they are determined to be distinct, the value of the intellectual property licenses would be recognized up-front while the research and development service fees would be recognized as the performance obligations are satisfied. Variable consideration is assessed at each reporting period as to whether it is not subject to future reversal of cumulative revenue and, therefore, should be included in the transaction price. Assessing the recognition of variable consideration requires significant judgment. If a contract includes a fixed or minimum amount of research and development support, this also would be included in the transaction price. Changes to collaboration and license agreements, such as the extensions of the research term or increasing the number of targets or technology covered under an existing agreement, are assessed for whether they represent a modification or should be accounted for as a new contract. We have concluded that the license of intellectual property in certain collaboration and license agreements is not distinct from the perspective of our customers at the time of initial transfer, since we often do not license intellectual property without related technology transfer and research and development support services. Such evaluation requires significant judgment since it is made from the customer's perspective. Our performance obligations under our collaborations may include such things as providing intellectual property licenses, performing technology transfer, performing research and development consulting services, providing reagents, ADCs, and other materials, and notifying the customer of any enhancements to licensed technology or new technology that we discover, among others. We determined our performance obligations under certain collaboration and license agreements as evaluated at contract inception were not distinct and represented a single performance obligation. Upfront payments are amortized to revenue over the performance period. Upfront payment contract liabilities resulting from our collaborations do not represent a financing component as the payment is not financing the transfer of goods or services, and the technology underlying the licenses granted reflects research and development expenses already incurred by us. For agreements beyond the initial performance period, we have no remaining performance obligations. We may receive license maintenance fees and potential milestones and royalties based on collaborator development and regulatory progress, which are recorded in the period achieved in the case of milestones, and during the period of the related sales for royalties. When no performance obligations are required of us, or following the completion of the performance obligation period, such amounts are recognized upon transfer of control of the goods or services to the customer. Generally, all amounts received or due other than sales-based milestones and royalties are classified as collaboration and license agreement revenues. Sales-based milestones and royalties are recognized as royalty revenue in the period the related sale occurred. We generally invoice our collaborators and licensees on a monthly or quarterly basis, or upon the completion of the effort or achievement of a milestone, based on the terms of each agreement. Deferred revenue arises from amounts received in advance of the culmination of the earnings process and is recognized as revenue in future periods as performance obligations are satisfied. Deferred revenue expected to be recognized within the next twelve months is classified as a current liability. |
Summary of significant accoun_3
Summary of significant accounting policies (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Policies [Abstract] | |
Schedule of Cash, Cash Equivalents | Our total cash, cash equivalents, and restricted cash, as presented in the condensed consolidated statements of cash flows, was as follows: (dollars in thousands) June 30, 2022 December 31, 2021 June 30, 2021 December 31, 2020 Cash and cash equivalents $ 364,874 $ 424,834 $ 413,434 $ 558,424 Restricted cash included in prepaid expenses and other current assets 9,949 — — — Total cash, cash equivalents, and restricted cash as presented in the condensed consolidated statements of cash flows $ 374,823 $ 424,834 $ 413,434 $ 558,424 |
Schedule of Cash, Cash Equivalents, and Restricted Cash | Our total cash, cash equivalents, and restricted cash, as presented in the condensed consolidated statements of cash flows, was as follows: (dollars in thousands) June 30, 2022 December 31, 2021 June 30, 2021 December 31, 2020 Cash and cash equivalents $ 364,874 $ 424,834 $ 413,434 $ 558,424 Restricted cash included in prepaid expenses and other current assets 9,949 — — — Total cash, cash equivalents, and restricted cash as presented in the condensed consolidated statements of cash flows $ 374,823 $ 424,834 $ 413,434 $ 558,424 |
Schedule of Finite-Lived Intangible Assets | The following table presents the balances of our finite-lived intangible assets for the periods presented: (dollars in thousands) June 30, 2022 December 31, 2021 Gross carrying value $ 305,650 $ 305,650 Less: accumulated amortization (56,501) (45,057) Total $ 249,149 $ 260,593 |
Schedule of Amortization Expense | The following table presents our amortization expense related to acquired TUKYSA technology costs, included in cost of sales in our condensed consolidated statements of comprehensive loss, for the periods presented: Three Months Ended June 30, Six Months Ended June 30, (dollars in thousands) 2022 2021 2022 2021 Amortization expense $ 5,753 $ 5,757 $ 11,444 $ 11,451 |
Revenue from contracts with c_2
Revenue from contracts with customers (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Revenue from Contract with Customer [Abstract] | |
Summary of Collaboration and License Agreement Revenues by Collaborator | The following table presents our disaggregated revenue for the periods presented. Three Months Ended June 30, Six Months Ended June 30, (dollars in thousands) 2022 2021 2022 2021 ADCETRIS $ 201,939 $ 181,912 $ 382,928 $ 344,484 PADCEV 123,577 82,405 223,784 152,163 TUKYSA 88,989 83,021 179,464 153,279 TIVDAK 17,209 — 28,624 — Net product sales $ 431,714 $ 347,338 $ 814,800 $ 649,926 Royalty revenues $ 39,109 $ 36,296 $ 67,290 $ 63,514 Collaboration and license agreement revenues $ 26,679 $ 4,844 $ 41,872 $ 7,020 Total revenues $ 497,502 $ 388,478 $ 923,962 $ 720,460 |
Leases (Tables)
Leases (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Leases [Abstract] | |
Summary of Supplemental Operating Lease Information | Supplemental operating lease information was as follows: Three Months Ended June 30, Six Months Ended June 30, (dollars in thousands) 2022 2021 2022 2021 Operating lease cost $ 3,947 $ 4,063 $ 8,142 $ 8,077 Variable lease cost 1,249 1,151 2,321 2,138 Total lease cost $ 5,196 $ 5,214 $ 10,463 $ 10,215 Cash paid for amounts included in measurement of lease liabilities $ 4,196 $ 4,199 $ 8,749 $ 8,057 As of June 30, 2022 2021 Weighted average remaining lease term 5.6 years 6.3 years Weighted average discount rate 5 % 5.1 % |
Summary of Operating Lease Assets and Liabilities | Operating lease liabilities were recorded in the following captions of our condensed consolidated balance sheet as follows: (dollars in thousands) June 30, 2022 December 31, 2021 Accrued liabilities and other $ 13,700 $ 13,905 Operating lease liabilities, long-term 50,205 56,665 Total $ 63,905 $ 70,570 |
Net loss per share (Tables)
Net loss per share (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Earnings Per Share [Abstract] | |
Schedule of Weighted Average Number of Shares | The following table presents the weighted average number of shares that have been excluded for all periods presented: Three Months Ended June 30, Six Months Ended June 30, (in thousands) 2022 2021 2022 2021 Stock options and RSUs 9,824 9,992 10,077 10,229 |
Fair value (Tables)
Fair value (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Summary of Fair Value Hierarchy of Assets Carried at Fair Value and Measured on a Recurring Basis | The fair value hierarchy of assets carried at fair value and measured on a recurring basis was as follows: Fair value measurement using: (dollars in thousands) Quoted prices Other Significant Total June 30, 2022 Short-term investments—U.S. Treasury securities $ 1,485,448 $ — $ — $ 1,485,448 Other non-current assets—equity securities 6,931 — — 6,931 Total $ 1,492,379 $ — $ — $ 1,492,379 December 31, 2021 Short-term investments—U.S. Treasury securities $ 1,735,202 $ — $ — $ 1,735,202 Other non-current assets—equity securities 14,009 — — 14,009 Total $ 1,749,211 $ — $ — $ 1,749,211 |
Summary of Debt Securities | Our debt securities consisted of the following: (dollars in thousands) Amortized Gross Gross Fair June 30, 2022 U.S. Treasury securities $ 1,489,231 $ 30 $ (3,813) $ 1,485,448 Contractual maturities (at date of purchase): Due in one year or less $ 1,473,502 $ 1,469,688 Due in one to two years 15,729 15,760 Total $ 1,489,231 $ 1,485,448 December 31, 2021 U.S. Treasury securities $ 1,735,388 $ 12 $ (198) $ 1,735,202 Contractual maturities (at date of purchase): Due in one year or less $ 1,635,307 $ 1,635,118 Due in one to two years 100,081 100,084 Total $ 1,735,388 $ 1,735,202 |
Investment and other income (_2
Investment and other income (loss), net (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of Investment and Other Income, Net | Investment and other income (loss), net consisted of the following: Three Months Ended June 30, Six Months Ended June 30, (dollars in thousands) 2022 2021 2022 2021 (Loss) gain on equity securities $ (4,299) $ 4,670 $ (7,078) $ 4,929 Investment and other income, net 2,690 357 3,279 1,098 Total investment and other (loss) income, net $ (1,609) $ 5,027 $ (3,799) $ 6,027 |
Inventories (Tables)
Inventories (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventories | Inventories consisted of the following: (dollars in thousands) June 30, 2022 December 31, 2021 Raw materials $ 15,541 $ 12,181 Work in process 259,805 152,635 Finished goods 44,008 35,847 Total $ 319,354 $ 200,663 |
Accrued liabilities (Tables)
Accrued liabilities (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Liabilities | Accrued liabilities consisted of the following: (dollars in thousands) June 30, 2022 December 31, 2021 Employee compensation and benefits $ 107,585 $ 139,052 Clinical trial and related costs 169,425 122,468 Contract manufacturing 24,211 21,867 Gross-to-net deductions and third-party royalties 95,094 81,316 Other 83,334 89,327 Total $ 479,649 $ 454,030 |
Share-based compensation (Table
Share-based compensation (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Share-based Compensation | The following table presents our total share-based compensation expense for the periods presented: Three Months Ended June 30, Six Months Ended June 30, (dollars in thousands) 2022 2021 2022 2021 Research and development $ 23,446 $ 17,232 $ 46,522 $ 34,196 Selling, general and administrative 30,683 20,495 51,520 41,755 Total share-based compensation expense $ 54,129 $ 37,727 $ 98,042 $ 75,951 |
Summary of significant accoun_4
Summary of significant accounting policies - Additional Information (Details) $ in Thousands | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2022 USD ($) segment | Dec. 31, 2021 USD ($) | Jun. 30, 2021 USD ($) | Dec. 31, 2020 USD ($) | |
Summary Of Significant Accounting Policies [Line Items] | ||||
Number of reporting segments | segment | 1 | |||
Accrued capital expenditures | $ 9,400 | $ 9,900 | ||
Accrued interest receivable | 2,200 | 400 | ||
Cash held in escrow restricted by a contractual agreement | 9,949 | $ 0 | $ 0 | $ 0 |
Estimated future amortization expense, remainder of fiscal year | 11,600 | |||
Estimated future amortization expense, 2023 | 23,100 | |||
Estimated future amortization expense, 2024 | 23,100 | |||
Estimated future amortization expense, 2025 | 23,100 | |||
Estimated future amortization expense, 2026 | 23,100 | |||
Estimated future amortization expense, 2027 | $ 23,100 | |||
Weighted Average | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Intangible asset useful life | 11 years |
Summary of significant accoun_5
Summary of significant accounting policies - Cash, Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 | Jun. 30, 2021 | Dec. 31, 2020 |
Accounting Policies [Abstract] | ||||
Cash and cash equivalents | $ 364,874 | $ 424,834 | $ 413,434 | $ 558,424 |
Restricted cash included in prepaid expenses and other current assets | 9,949 | 0 | 0 | 0 |
Total cash, cash equivalents, and restricted cash as presented in the condensed consolidated statements of cash flows | $ 374,823 | $ 424,834 | $ 413,434 | $ 558,424 |
Summary of significant accoun_6
Summary of significant accounting policies - Finite-lived intangible Assets (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Accounting Policies [Abstract] | ||
Gross carrying value | $ 305,650 | $ 305,650 |
Less: accumulated amortization | (56,501) | (45,057) |
Total | $ 249,149 | $ 260,593 |
Summary of significant accoun_7
Summary of significant accounting policies - Amortization Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Accounting Policies [Abstract] | ||||
Amortization expense | $ 5,753 | $ 5,757 | $ 11,444 | $ 11,451 |
Revenue from contracts with c_3
Revenue from contracts with customers - Summary of Collaboration and License Agreement Revenues by Collaborator (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Disaggregation of Revenue [Line Items] | ||||
Collaboration and license agreement revenues | $ 497,502 | $ 388,478 | $ 923,962 | $ 720,460 |
Net product sales | ||||
Disaggregation of Revenue [Line Items] | ||||
Collaboration and license agreement revenues | 431,714 | 347,338 | 814,800 | 649,926 |
Net product sales | ADCETRIS | ||||
Disaggregation of Revenue [Line Items] | ||||
Collaboration and license agreement revenues | 201,939 | 181,912 | 382,928 | 344,484 |
Net product sales | PADCEV | ||||
Disaggregation of Revenue [Line Items] | ||||
Collaboration and license agreement revenues | 123,577 | 82,405 | 223,784 | 152,163 |
Net product sales | TUKYSA | ||||
Disaggregation of Revenue [Line Items] | ||||
Collaboration and license agreement revenues | 88,989 | 83,021 | 179,464 | 153,279 |
Net product sales | TIVDAK | ||||
Disaggregation of Revenue [Line Items] | ||||
Collaboration and license agreement revenues | 17,209 | 0 | 28,624 | 0 |
Royalty revenues | ||||
Disaggregation of Revenue [Line Items] | ||||
Collaboration and license agreement revenues | 39,109 | 36,296 | 67,290 | 63,514 |
Collaboration and license agreement revenues | ||||
Disaggregation of Revenue [Line Items] | ||||
Collaboration and license agreement revenues | $ 26,679 | $ 4,844 | $ 41,872 | $ 7,020 |
Leases - Additional Information
Leases - Additional Information (Details) ft² in Thousands, $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 USD ($) ft² a term | Jun. 30, 2022 USD ($) | Jun. 30, 2021 USD ($) ft² term | Jun. 30, 2022 USD ($) | Jun. 30, 2021 USD ($) ft² term | |
Leases [Abstract] | |||||
Right-of-use assets in exchange for lease liabilities | $ 200 | $ 7,100 | |||
Lease agreement, rented area | ft² | 258 | 258 | 258 | ||
Rentable building and complex constructed (in acres) | a | 20.5 | ||||
Initial rate | $ 4,000 | $ 4,196 | $ 4,199 | $ 8,749 | $ 8,057 |
Annual escalations | 3% | ||||
Initial term | 20 years | 20 years | 20 years | ||
Option to extend | term | 2 | 2 | 2 | ||
Renewal term | 10 years | 10 years | 10 years |
Leases - Lease Cost (Details)
Leases - Lease Cost (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Leases [Abstract] | |||||
Operating lease cost | $ 3,947 | $ 4,063 | $ 8,142 | $ 8,077 | |
Variable lease cost | 1,249 | 1,151 | 2,321 | 2,138 | |
Total lease cost | 5,196 | 5,214 | 10,463 | 10,215 | |
Cash paid for amounts included in measurement of lease liabilities | $ 4,000 | $ 4,196 | $ 4,199 | $ 8,749 | $ 8,057 |
Weighted average remaining lease term | 6 years 3 months 18 days | 5 years 7 months 6 days | 6 years 3 months 18 days | 5 years 7 months 6 days | 6 years 3 months 18 days |
Weighted average discount rate | 5.10% | 5% | 5.10% | 5% | 5.10% |
Leases - Summary of Balance She
Leases - Summary of Balance Sheet Information (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Leases [Abstract] | ||
Operating Lease, Liability, Current, Statement of Financial Position [Extensible Enumeration] | Accrued liabilities and other | Accrued liabilities and other |
Accrued liabilities and other | $ 13,700 | $ 13,905 |
Operating lease liabilities, long-term | 50,205 | 56,665 |
Total | $ 63,905 | $ 70,570 |
Net loss per share (Details)
Net loss per share (Details) - shares shares in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Earnings Per Share [Abstract] | ||||
Stock options and RSUs (in shares) | 9,824 | 9,992 | 10,077 | 10,229 |
Fair value - Summary of Fair Va
Fair value - Summary of Fair Value Hierarchy of Assets Carried at Fair Value and Measured on a Recurring Basis (Details) - Fair Value Measurements Recurring - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | $ 1,492,379 | $ 1,749,211 |
US Treasury Securities | Short-term Investments | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 1,485,448 | 1,735,202 |
Equity Securities | Other Non-current Assets | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 6,931 | 14,009 |
Quoted prices in active markets for identical assets (Level 1) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 1,492,379 | 1,749,211 |
Quoted prices in active markets for identical assets (Level 1) | US Treasury Securities | Short-term Investments | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 1,485,448 | 1,735,202 |
Quoted prices in active markets for identical assets (Level 1) | Equity Securities | Other Non-current Assets | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 6,931 | 14,009 |
Other observable inputs (Level 2) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 0 | 0 |
Other observable inputs (Level 2) | US Treasury Securities | Short-term Investments | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 0 | 0 |
Other observable inputs (Level 2) | Equity Securities | Other Non-current Assets | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 0 | 0 |
Significant unobservable inputs (Level 3) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 0 | 0 |
Significant unobservable inputs (Level 3) | US Treasury Securities | Short-term Investments | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 0 | 0 |
Significant unobservable inputs (Level 3) | Equity Securities | Other Non-current Assets | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | $ 0 | $ 0 |
Fair value - Additional Informa
Fair value - Additional Information (Details) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | |
Fair Value Disclosures [Abstract] | |||||
Credit loss | $ 0 | $ 0 | $ 0 | $ 0 | |
Allowance for credit loss | $ 0 | $ 0 | $ 0 |
Fair value - Summary of Debt Se
Fair value - Summary of Debt Securities (Details) - US Treasury Securities - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Debt Securities, Available-for-sale [Line Items] | ||
Amortized cost | $ 1,489,231 | $ 1,735,388 |
Gross unrealized gains | 30 | 12 |
Gross unrealized losses | (3,813) | (198) |
Fair value | 1,485,448 | 1,735,202 |
Debt securities, due in one year or less, amortized cost | 1,473,502 | 1,635,307 |
Debt securities, due in one year or less, fair value | 1,469,688 | 1,635,118 |
Debt securities, due in one to two years, amortized cost | 15,729 | 100,081 |
Debt securities, due in one to two years, fair value | $ 15,760 | $ 100,084 |
Investment and other income (_3
Investment and other income (loss), net (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Investments, Debt and Equity Securities [Abstract] | ||||
(Loss) gain on equity securities | $ (4,299) | $ 4,670 | $ (7,078) | $ 4,929 |
Investment and other income, net | 2,690 | 357 | 3,279 | 1,098 |
Total investment and other (loss) income, net | $ (1,609) | $ 5,027 | $ (3,799) | $ 6,027 |
Inventories (Details)
Inventories (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 15,541 | $ 12,181 |
Work in process | 259,805 | 152,635 |
Finished goods | 44,008 | 35,847 |
Total | $ 319,354 | $ 200,663 |
Accrued liabilities (Details)
Accrued liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Payables and Accruals [Abstract] | ||
Employee compensation and benefits | $ 107,585 | $ 139,052 |
Clinical trial and related costs | 169,425 | 122,468 |
Contract manufacturing | 24,211 | 21,867 |
Gross-to-net deductions and third-party royalties | 95,094 | 81,316 |
Other | 83,334 | 89,327 |
Total | $ 479,649 | $ 454,030 |
Share-based compensation (Detai
Share-based compensation (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
May 15, 2022 | Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Share-based compensation expense | $ 54,129 | $ 37,727 | $ 98,042 | $ 75,951 | |
Unrecognized compensation cost | 105,700 | 105,700 | |||
Acceleration period following separation | 18 months | ||||
Expiration period | 10 years | ||||
Share-based payment arrangement, plan modification, incremental cost | 7,300 | ||||
Research and development | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Share-based compensation expense | 23,446 | 17,232 | 46,522 | 34,196 | |
Selling, general and administrative | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Share-based compensation expense | 30,683 | $ 20,495 | 51,520 | $ 41,755 | |
Long Term Incentive Plans | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Unrecognized compensation costs, excluding options | $ 71,000 | $ 71,000 |
Income taxes (Details)
Income taxes (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Income Tax Disclosure [Abstract] | ||||
Provision for income taxes | $ 107,000 | $ 0 | $ 1,361,000 | $ 0 |
Effective income tax rate | 0.10% | 0.50% |
Legal matters (Details)
Legal matters (Details) - Patent Infringement $ in Millions | 1 Months Ended | |
Apr. 08, 2022 USD ($) | Jan. 22, 2021 petition | |
Subsequent Event [Line Items] | ||
Number of petitions filed | petition | 2 | |
Awarded damages for past infringement | $ | $ 41.8 |