Cover Page
Cover Page - USD ($) $ in Billions | 12 Months Ended | ||
Dec. 31, 2020 | Feb. 09, 2021 | Jun. 30, 2020 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2020 | ||
Current Fiscal Year End Date | --12-31 | ||
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, Address Line One | 21823 30th Drive SE | ||
Entity Address, City or Town | Bothell | ||
Entity Address, State or Province | WA | ||
Entity Address, 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 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 Emerging Growth Company | false | ||
Entity Small Business | false | ||
ICFR Auditor Attestation Flag | true | ||
Entity Shell Company | false | ||
Entity Public Float | $ 21.1 | ||
Entity Common Stock, Shares Outstanding | 181,164,446 | ||
Documents Incorporated by Reference | Part III incorporates information by reference from the registrant’s definitive proxy statement to be filed with the Securities and Exchange Commission pursuant to Regulation 14A, not later than 120 days after the end of the fiscal year covered by this Annual Report on Form 10-K, in connection with the registrant’s 2021 Annual Meeting of Stockholders. | ||
Amendment Flag | false | ||
Document Fiscal Year Focus | 2020 | ||
Document Fiscal Period Focus | FY | ||
Entity Central Index Key | 0001060736 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 558,424 | $ 274,562 |
Short-term investments | 2,000,996 | 536,493 |
Accounts receivable, net | 324,988 | 236,001 |
Inventories | 116,136 | 85,932 |
Prepaid expenses and other current assets | 61,840 | 43,653 |
Total current assets | 3,062,384 | 1,176,641 |
Property and equipment, net | 196,700 | 155,491 |
Operating lease right-of-use assets | 61,480 | 65,230 |
Long-term investments | 100,830 | 57,283 |
Intangible assets, net | 283,680 | 300,025 |
Goodwill | 274,671 | 274,671 |
Other non-current assets | 21,161 | 176,525 |
Total assets | 4,000,906 | 2,205,866 |
Current liabilities: | ||
Accounts payable | 78,067 | 52,292 |
Accrued liabilities and other | 310,071 | 207,065 |
Total current liabilities | 388,138 | 259,357 |
Long-term liabilities: | ||
Operating lease liabilities, long-term | 61,884 | 67,607 |
Other long-term liabilities | 62,784 | 2,615 |
Total long-term liabilities | 124,668 | 70,222 |
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; 180,902 shares issued and outstanding at December 31, 2020 and 171,994 shares issued and outstanding at December 31, 2019 | 181 | 172 |
Additional paid-in capital | 4,356,922 | 3,359,124 |
Accumulated other comprehensive income | 565 | 229 |
Accumulated deficit | (869,568) | (1,483,238) |
Total stockholders’ equity | 3,488,100 | 1,876,287 |
Total liabilities and stockholders’ equity | $ 4,000,906 | $ 2,205,866 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2020 | Dec. 31, 2019 |
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) | 180,902,000 | 171,994,000 |
Common stock, shares outstanding (in shares) | 180,902,000 | 171,994,000 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Income (Loss) - USD ($) shares in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Revenues: | |||
Total revenues | $ 2,175,536,000 | $ 916,713,000 | $ 654,700,000 |
Costs and expenses: | |||
Cost of sales | 217,720,000 | 43,952,000 | 88,293,000 |
Research and development | 827,129,000 | 719,374,000 | 565,309,000 |
Selling, general and administrative | 533,835,000 | 373,932,000 | 261,096,000 |
Total costs and expenses | 1,578,684,000 | 1,137,258,000 | 914,698,000 |
Income (loss) from operations | 596,852,000 | (220,545,000) | (259,998,000) |
Investment and other income, net | 18,849,000 | 61,895,000 | 13,652,000 |
Income (loss) before income taxes | 615,701,000 | (158,650,000) | (246,346,000) |
Income tax benefit (expense) | (2,031,000) | 0 | 23,653,000 |
Net income (loss) | $ 613,670,000 | $ (158,650,000) | $ (222,693,000) |
Net income (loss) per share - basic (in dollars per share) | $ 3.51 | $ (0.96) | $ (1.41) |
Net income (loss) per share - diluted (in dollars per share) | $ 3.37 | $ (0.96) | $ (1.41) |
Shares used in computation of per share amounts - basic (in shares) | 174,834 | 165,498 | 157,655 |
Shares used in computation of per share amounts - diluted (in shares) | 182,287 | 165,498 | 157,655 |
Comprehensive income (loss): | |||
Net income (loss) | $ 613,670,000 | $ (158,650,000) | $ (222,693,000) |
Other comprehensive income: | |||
Unrealized (loss) gain on securities available-for-sale, net of income tax provision of $0, $0, and $0, respectively | (186,000) | 204,000 | 293,000 |
Foreign currency translation gain (loss), net of income tax provision of $0, $0, and $0, respectively | 522,000 | 65,000 | (50,000) |
Total other comprehensive income | 336,000 | 269,000 | 243,000 |
Comprehensive income (loss) | 614,006,000 | (158,381,000) | (222,450,000) |
Product [Member] | |||
Revenues: | |||
Total revenues | 1,000,598,000 | 627,977,000 | 476,903,000 |
Royalty [Member] | |||
Revenues: | |||
Total revenues | 126,756,000 | 138,491,000 | 83,440,000 |
Collaboration and License Agreement [Member] | |||
Revenues: | |||
Total revenues | $ 1,048,182,000 | $ 150,245,000 | $ 94,357,000 |
Consolidated Statements of Co_2
Consolidated Statements of Comprehensive Income (Loss) (Parenthetical) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Income Statement [Abstract] | |||
Unrealized gain (loss) on securities available-for-sale, tax | $ 0 | $ 0 | $ 0 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) shares in Thousands, $ in Thousands | Total | Cumulative Effect, Period of Adoption, Adjustment [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Other Comprehensive Income (Loss) [Member] | Accumulated Other Comprehensive Income (Loss) [Member]Cumulative Effect, Period of Adoption, Adjustment [Member] | Accumulated Deficit [Member] | Accumulated Deficit [Member]Cumulative Effect, Period of Adoption, Adjustment [Member] |
Balances, shares (in shares) at Dec. 31, 2017 | 144,395 | |||||||
Balances, value at Dec. 31, 2017 | $ 677,569 | $ 26,556 | $ 144 | $ 1,806,159 | $ 63,836 | $ (64,119) | $ (1,192,570) | $ 90,675 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Net income (loss) | (222,693) | (222,693) | ||||||
Other comprehensive income | 243 | 243 | ||||||
Stock option exercises (in shares) | 2,006 | |||||||
Issuance of common stock for stock option exercises and employee stock purchase plan | 55,165 | $ 2 | 55,163 | |||||
Restricted stock vested during the period, net (in shares) | 592 | |||||||
Restricted stock vested during the period, net | 0 | $ 1 | (1) | |||||
Issuance of common stock (in shares) | 13,269 | |||||||
Issuance of common stock | 658,242 | $ 13 | 658,229 | |||||
Share-based compensation | 78,861 | 78,861 | ||||||
Balances, shares (in shares) at Dec. 31, 2018 | 160,262 | |||||||
Balances, value at Dec. 31, 2018 | 1,273,943 | $ 160 | 2,598,411 | (40) | (1,324,588) | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Net income (loss) | (158,650) | (158,650) | ||||||
Other comprehensive income | 269 | 269 | ||||||
Stock option exercises (in shares) | 2,621 | |||||||
Issuance of common stock for stock option exercises and employee stock purchase plan | 89,151 | $ 3 | 89,148 | |||||
Restricted stock vested during the period, net (in shares) | 897 | |||||||
Restricted stock vested during the period, net | 0 | $ 1 | (1) | |||||
Issuance of common stock (in shares) | 8,214 | |||||||
Issuance of common stock | 548,691 | $ 8 | 548,683 | |||||
Share-based compensation | $ 122,883 | 122,883 | ||||||
Balances, shares (in shares) at Dec. 31, 2019 | 171,994 | 171,994 | ||||||
Balances, value at Dec. 31, 2019 | $ 1,876,287 | $ 172 | 3,359,124 | 229 | (1,483,238) | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Net income (loss) | 613,670 | 613,670 | ||||||
Other comprehensive income | 336 | 336 | ||||||
Stock option exercises (in shares) | 2,466 | |||||||
Issuance of common stock for stock option exercises and employee stock purchase plan | 96,257 | $ 2 | 96,255 | |||||
Restricted stock vested during the period, net (in shares) | 1,442 | |||||||
Restricted stock vested during the period, net | 0 | $ 2 | (2) | |||||
Issuance of common stock (in shares) | 5,000 | |||||||
Issuance of common stock | 749,850 | $ 5 | 749,845 | |||||
Share-based compensation | $ 151,700 | 151,700 | ||||||
Balances, shares (in shares) at Dec. 31, 2020 | 180,902 | 180,902 | ||||||
Balances, value at Dec. 31, 2020 | $ 3,488,100 | $ 181 | $ 4,356,922 | $ 565 | $ (869,568) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Operating activities: | |||
Net income (loss) | $ 613,670 | $ (158,650) | $ (222,693) |
Adjustments to reconcile net income (loss) to net cash provided (used) by operating activities | |||
Share-based compensation | 147,233 | 127,349 | 78,861 |
Depreciation and amortization | 36,045 | 23,759 | 25,308 |
Amortization of intangible assets | 16,345 | 15 | 724 |
Amortization of right-of-use-assets | 10,994 | 9,740 | |
Amortization of premiums, accretion of discounts, and (gains) losses on debt securities | 3,104 | (4,916) | (2,530) |
Gain on equity securities | (11,604) | (50,124) | (7,336) |
(Gain) loss on disposals of property and equipment | (26) | 1,853 | 0 |
Deferred income taxes | (2,053) | 0 | (23,653) |
Changes in operating assets and liabilities: | |||
Accounts receivable, net | (88,727) | (89,720) | (45,233) |
Inventories | (30,204) | (32,693) | 6,739 |
Prepaid expenses and other assets | (22,231) | 2,459 | (14,567) |
Lease liabilities | (11,271) | (6,660) | |
Deferred revenue | 0 | (33,600) | (33,913) |
Other liabilities | 195,293 | 47,451 | 34,757 |
Net cash provided (used) by operating activities | 856,568 | (163,737) | (203,536) |
Investing activities: | |||
Purchases of securities | (2,483,336) | (992,976) | (512,334) |
Proceeds from maturities of securities | 952,000 | 786,000 | 398,722 |
Proceeds from sales of securities | 194,733 | 0 | 140,352 |
Purchases of property and equipment | (82,409) | (70,753) | (21,219) |
Acquisition of Cascadian Therapeutics, Inc., net of cash acquired | 0 | 0 | (598,151) |
Net cash used by investing activities | (1,419,012) | (277,729) | (592,630) |
Financing activities: | |||
Net proceeds from issuance of common stock | 749,850 | 548,691 | 658,242 |
Proceeds from exercise of stock options and employee stock purchase plan | 96,258 | 89,151 | 55,165 |
Net cash provided by financing activities | 846,108 | 637,842 | 713,407 |
Effect of exchange rate changes on cash and cash equivalents | 198 | 0 | 0 |
Net increase (decrease) in cash and cash equivalents | 283,862 | 196,376 | (82,759) |
Cash and cash equivalents at beginning of year | 274,562 | 78,186 | 160,945 |
Cash and cash equivalents at end of year | $ 558,424 | $ 274,562 | $ 78,186 |
Organization and Summary of Sig
Organization and Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Organization and Summary of Significant Accounting Policies | Organization and Summary of Significant Accounting Policies Organization We are a biotechnology company that develops and commercializes targeted therapies to treat cancer. We are commercializing ADCETRIS®, or brentuximab vedotin, for the treatment of certain CD30-expressing lymphomas, PADCEV®, or enfortumab vedotin-ejfv, for the treatment of certain metastatic urothelial cancers, and TUKYSA®, or tucatinib, for treatment of certain metastatic HER2-positive breast cancers. We are also advancing a pipeline of novel therapies for solid tumors and blood-related cancers designed to address unmet medical needs and improve treatment outcomes for patients. Many of our programs, including ADCETRIS and PADCEV, are based on our antibody-drug conjugate, or ADC, technology that utilizes the targeting ability of monoclonal antibodies to deliver cell-killing agents directly to cancer cells. In October 2020, we changed our corporate name from Seattle Genetics, Inc. to Seagen Inc., reflecting the global expansion of our operations. Basis of presentation The accompanying consolidated financial statements reflect the accounts of Seagen Inc. and its wholly-owned subsidiaries (collectively “Seagen,” “we,” “our,” or “us”). The consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles, or GAAP. All intercompany transactions and balances have been eliminated. We acquired Cascadian Therapeutics, Inc., or Cascadian, in March 2018, as further described in Note 4. 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. Use of estimates The preparation of financial statements in accordance with GAAP requires us to make estimates, assumptions, and judgments that affect the amounts reported in the consolidated financial statements and accompanying notes. Actual results could differ from those estimates. Estimates include those used for revenue recognition, valuation of investments, inventory valuation, business combinations, accrued liabilities (including those related to the long-term incentive plans, clinical trials and contingencies), stock option valuation, and valuation allowance for deferred tax assets. Reclassifications We combined cost of sales with cost of royalty revenues during the current year and reclassified the prior years cost of royalty revenues on our consolidated statements of comprehensive income (loss), to conform to the current year presentation. This reclassification had no effect on our net cash used by operating activities or our consolidated statements of comprehensive income (loss). Cash and cash equivalents We consider all highly liquid investments with maturities of three months or less at the date of acquisition to be cash equivalents. Non-cash activities We had $6.0 million and $11.1 million of accrued capital expenditures as of December 31, 2020 and 2019, respectively. Accrued capital expenditures have been treated as a non-cash investing activity and, accordingly, have not been included in the consolidated statement of cash flows until such amounts have been paid in cash. During the years ended December 31, 2020 and 2019, we recorded $7.2 million and $40.3 million, respectively, of right-of-use assets in exchange for lease liabilities, which has been treated as a non-cash operating activity. See Note 3 for additional information. Investments We held certain equity securities that we acquired in connection with strategic agreements, which were reported at estimated fair value. Changes 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 adopted Accounting Standards Update, or ASU, “ASU 2016-01, Financial Instruments: Overall” on January 1, 2018, which addressed certain aspects of recognition, measurement, presentation and disclosure of financial instruments, including that changes in the fair value of equity securities be recorded in income or loss rather than accumulated other comprehensive income or loss in stockholders’ equity. We used the modified retrospective method transition option and recognized a $64.1 million cumulative effect of initially applying this ASU as an adjustment to decrease the opening accumulated deficit at January 1, 2018. 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 and 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, 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, net. Interest and dividends earned are included in investment and other income, net. We classify 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, net. Fair value of financial instruments The recorded amounts of certain financial instruments, including cash and cash equivalents, interest receivable, accounts receivable, accounts payable and accrued liabilities approximate fair value due to their relatively short maturities. Investments that are classified as available-for-sale are recorded at estimated fair value. The estimated fair value for securities held is determined using quoted market prices, broker or dealer quotations, or alternative pricing sources with reasonable levels of price transparency. Leases We adopted Accounting Standards Codification, or ASC, Topic 842--Leases on January 1, 2019, resulting in a change to our accounting policy for leases. We recorded a liability to make lease payments and a right-of-use asset representing our right to use the underlying assets for the applicable lease terms in our consolidated balance sheet. We used the modified retrospective method transition option. Accordingly, 2018 comparative information has not been adjusted and continues to be reported under previous accounting standards. We elected the "package of practical expedients", which permitted us not to reassess our prior conclusion about lease identification, lease classification and initial direct cost. We also elected the practical expedient to not separate lease and non-lease components for our real estate leases, and elected the short-term lease recognition exemption for our short-term leases, which allows us not to recognize lease liabilities and right-of-use assets on our consolidated balance sheet for leases with an original term of twelve months or less. The adoption of the standard had a material impact on our consolidated balance sheet, did not have an impact on our consolidated statement of comprehensive income (loss), and there was no cumulative-effect adjustment to the opening accumulated deficit in the period of adoption. See Note 3 for additional information. We determine if an arrangement is a lease at inception date. All of our leases are classified as operating leases. Operating lease liabilities and the corresponding right-of-use assets are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. The operating lease right-of-use asset also excludes lease incentives and initial direct costs incurred. As our existing leases do not contain an implicit interest rate, we estimate our incremental borrowing rate based on information available at commencement date in determining the present value of future payments. We include options to extend the lease in our lease liability and right-of-use asset when it is reasonably certain that we will exercise that option. Our lease agreements do not contain any material residual value guarantees or material restrictive covenants. Variable lease cost primarily includes building operating expenses as charged to us by our landlords. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term. For our short-term leases, we recognize lease payments as an expense on a straight-line base over the lease term. Inventories We consider regulatory approval of product candidates to be uncertain. Accordingly, we charge manufacturing costs to research and development expense until such time as a product has received regulatory approval for commercial sale. Production costs for our marketed products are capitalized into inventory. Inventory that is deployed for clinical, research or development use is charged to research and development expense when it is no longer available for commercial sales. Production costs for our other product candidates continue to be charged to research and development expense. We value our inventories at the lower of cost or market value. Cost is determined on a specific identification basis. Inventory includes the cost of materials, third-party contract manufacturing and overhead associated with the production of our commercialized products. In the event that we identify excess, obsolete or unsalable inventory, its value is written down to net realizable value. Property and equipment Property and equipment are stated at cost. Land is not depreciated, while all other property and equipment are depreciated using the straight-line method over the estimated useful lives of the assets, which are generally as follows: Years Building 30 Laboratory and manufacturing equipment 5-15 Furniture and fixtures 5 Computers, software and office equipment 3 Leasehold improvements are amortized over the shorter of the remaining term of the applicable lease or the useful life of the asset. Gains and losses from the disposal of property and equipment are reflected in income or loss at the time of disposition and have not been significant. Expenditures for additions and improvements to our facilities are capitalized and expenditures for maintenance and repairs are charged to expense as incurred. Business combinations, including acquired in-process research and development and goodwill We account for business combinations using the acquisition method, recording the acquisition-date fair value of total consideration over the acquisition-date fair value of net assets acquired as goodwill. Fair value is typically estimated using an income approach based on the present value of future discounted cash flows. The significant estimates in the discounted cash flow model primarily include the discount rate, and rates of future revenue and expense growth and/or profitability of the acquired business. The discount rate considers the relevant risk associated with business-specific characteristics and the uncertainty related to the ability to achieve the projected cash flows. We may record adjustments to the fair values of assets acquired and liabilities assumed within the measurement period (up to one year from the acquisition date). In-process research and development assets are accounted for as indefinite-lived intangible assets and maintained on the balance sheet until either the underlying project is completed or the asset becomes impaired. If the project is completed, which generally occurs when FDA approval is obtained, the carrying value of the related intangible asset is amortized to cost of sales on a straight-line basis over the estimated useful life of the asset beginning in the period in which the project is completed. We periodically evaluate when facts or circumstances indicate that the carrying value of these assets may not be recoverable. If the asset becomes impaired or is abandoned, the carrying value of the related intangible asset is written down to its fair value and an impairment charge is recorded in the period in which the impairment occurs. We evaluate indefinite-lived intangible assets and goodwill for impairment annually, as of October 1, or more frequently when events or circumstances indicate that impairment may have occurred. As part of the impairment evaluation, we may elect to perform an assessment of qualitative factors. If this qualitative assessment indicates that it is more likely than not that the fair value of the indefinite-lived intangible asset or the reporting unit (for goodwill) is less than its carrying value, we then would proceed with the quantitative impairment test to compare the fair value to the carrying value and record an impairment charge if the carrying value exceeds the fair value. Acquisition-related costs, including banking, legal, accounting, valuation, and other similar costs, are expensed in the period in which the costs are incurred. The results of operations of the acquired business are included in the consolidated financial statements from the acquisition date. Intangible assets, net Our intangible assets are primarily comprised of acquired TUKYSA technology from the acquisition of Cascadian Therapeutics, Inc. in 2018. Upon FDA approval and commercial launch of TUKYSA in April 2020, we classified in-process research and development costs related to the acquired TUKYSA technology as finite-lived intangible assets. Prior to 2020, our finite-lived intangible assets consisted of certain in-licensed ADCETRIS technology. Amortization expense of $16.3 million related to acquired TUKYSA technology costs for the year ended December 31, 2020, was included in cost of sales in our consolidated statements of comprehensive income (loss). The gross carrying value and accumulated amortization of our finite-lived intangible assets was $305.7 million and $22.0 million respectively as of December 31, 2020, and gross carrying value and accumulated amortization of our finite-lived intangible assets was $5.7 million and $5.6 million respectively as of December 31, 2019. The weighted average useful life of our finite-lived intangible assets was 12 years as of December 31, 2020, and estimated future amortization expense related to acquired TUKYSA technology costs is $23.1 million for each of the years ending December 31, 2021 through December 31, 2025. Impairment of long-lived assets (other than acquired in-process research and development and goodwill) We assess the impairment of long-lived assets, including intangible assets and property and equipment, whenever events or changes in business circumstances indicate that the carrying amounts of the assets may not be fully recoverable. When such events occur, we determine whether there has been an impairment in value by comparing the asset’s carrying value with its fair value, as measured by the anticipated undiscounted net cash flows of the asset. If an impairment in value exists, the asset is written down to its estimated fair value. We have not recognized any impairment losses through December 31, 2020 as there have been no events warranting an impairment analysis. Our long-lived assets are primarily located in the U.S. Revenue recognition - Net product sales We adopted ASC Topic 606--Revenue from Contracts with Customers on January 1, 2018, resulting in a change to our accounting policy for revenue recognition. We used the modified retrospective method transition option and recognized the cumulative effect of initially applying ASC Topic 606 as an adjustment to decrease the opening accumulated deficit at January 1, 2018. See Note 2 for additional information. We sell ADCETRIS, PADCEV and TUKYSA through a limited number of specialty distributors and specialty pharmacies. We and our collaboration partner Astellas jointly promote PADCEV in the U.S. Under the joint promotion in the U.S., we record net sales of PADCEV and are responsible for all distribution through a limited number of specialty distributors. 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 title and risk of loss pass. 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. We have applied a portfolio approach as a practical expedient for estimating net product sales. 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, distributors process a chargeback to us for the difference between wholesale acquisition cost and the applicable discounted price. 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. 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. 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 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. For those agreements, revenue is recognized using a proportional performance model, representing the transfer of goods or services as activities are performed over the term of the agreement. Upfront payments are also 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. Research and development expenses Research and development, or R&D, expenses consist of salaries, benefits and other headcount-related costs of our R&D staff, preclinical activities, clinical trials and related manufacturing costs, lab supplies, contract and outside service fees and facilities and overhead expenses for research, development and preclinical studies focused on drug discovery, development and testing. R&D activities are expensed as incurred. Clinical trial expenses are a significant component of research and development expenses, and we outsource a significant portion of these costs to third parties. Third-party clinical trial expenses include investigator fees, site costs, clinical research organization costs, and costs for central laboratory testing and data management. Costs associated with activities performed under co-development collaborations are reflected in R&D expense. In-licensing fees, milestones, maintenance fees and other costs to acquire technologies utilized in R&D for product candidates that have not yet received regulatory approval and that are not expected to have alternative future use are expensed when incurred. Non-refundable advance payments for goods or services that will be used or rendered for future R&D activities are capitalized and recognized as expense as the related goods are delivered or the related services are performed. This results in the temporary deferral of recording expense for amounts incurred for research and development activities from the time payments are made until the time goods or services are provided. Advertising Advertising costs are expensed as incurred. We incurred $59.3 million, $33.5 million, and $26.6 million in advertising expenses during 2020, 2019, and 2018, respectively. Concentration of credit risk Cash, cash equivalents and investments are invested in accordance with our investment policy. The policy includes guidelines for the investment of cash reserves and is reviewed periodically to minimize credit risk. Most of our investments are in U.S. Treasury securities and are not federally insured. We have accounts receivable from the sale of our products from a small number of distributors, and from our collaborators. We do not require collateral on amounts due from our distributors or our collaborators and are therefore subject to credit risk. Allowance for doubtful accounts We estimate an allowance for doubtful accounts based on our assessment of the collectability of customer accounts. We regularly review the allowance by considering factors such as historical experience, credit quality, the age of the accounts receivable balances, and current economic conditions that may affect a customer’s ability to pay. As of December 31, 2020 and 2019, there was no allowance for doubtful accounts, and we recognized no bad debt expense during the years ending December 31, 2020, 2019, and 2018. Geographic and customer information 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. We sell our products throug h a limited nu mber of d istributors and specialty pharmacies. The following table presents each major distributor or collaborator that comprised more than 10% of total revenue: Years ended December 31, 2020 2019 2018 Distributor A 18 % 26 % 28 % Distributor B 15 % 21 % 22 % Distributor C 10 % 18 % 20 % Collaborator B 45 % — % — % Collaborator A 7 % 27 % 21 % The following table presents each major distributor or collaborator that accounted for more than 10% of accounts receivable: December 31, 2020 2019 Distributor A 32 % 24 % Distributor B 25 % 19 % Distributor C 16 % 16 % Collaborator A 13 % 33 % Major suppliers The use of a relatively small number of contract manufacturers to supply drug necessary for our commercial and clinical operations create a concentration of risk for us. While primarily one source of supply is utilized for certain components of ADCETRIS, PADCEV, TUKYSA and each of our clinical product candidates, other sources are available should we need to change suppliers. For PADCEV, in particular, we rely on Astellas for both commercial and clinical supply as Astellas oversees the manufacturing supply chain. As a form of reducing near-term risk, we also endeavor to maintain reasonable levels of drug supply inventory across the supply chain. A change in suppliers or disruption at one of our suppliers, however, could cause a delay or interruption in delivery of drug or clinical trials. Such an event would adversely affect our business. Income taxes 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. Deferred tax assets and liabilities are determined based on the differences between the financial statement and tax bases of assets and liabilities using tax rates in effect for the year in which the differences are expected to reverse. We have provided a valuation allowance against substantially all our deferred tax assets for all periods presented. A valuation allowance is recorded when it is more likely than not that the net deferred tax asset will not be realized. We follow the guidance related to accounting for uncertainty in income taxes, which requires the recognition of an uncertain tax position when it is more likely than not to be sustainable upon audit by the applicable taxing authority. Share-based compensation We use the graded-vesting attribution method for recognizing compensation expense for our stock options and restricted stock units, or RSUs. Compensation expense is recognized over the requisite service periods on awards ultimately expected to vest and reduced for forfeitures that are estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. For performance-based stock options and RSUs, we record compensation expense over the estimated service period once the achievement of the performance-based milestone is considered probable. At each reporting date, we assess whether achievement of a milestone is considered probable, and if so, record compensation expense based on the portion of the service period elapsed to date w |
Revenue from contracts with cus
Revenue from contracts with customers | 12 Months Ended |
Dec. 31, 2020 | |
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 years presented: Years ended December 31, (dollars in thousands) 2020 2019 2018 ADCETRIS $ 658,577 $ 627,733 $ 476,903 PADCEV 222,436 244 — TUKYSA 119,585 — — Net product sales $ 1,000,598 $ 627,977 $ 476,903 Royalty revenues $ 126,756 $ 138,491 $ 83,440 Merck $ 975,150 $ — $ — Takeda 32,107 108,175 58,605 Other 40,925 42,070 35,752 Collaboration and license agreement revenues $ 1,048,182 $ 150,245 $ 94,357 Total revenues $ 2,175,536 $ 916,713 $ 654,700 Substantially all of our product revenues during the years ended December 31, 2020, 2019, and 2018 were recorded in the U.S. Royalty revenues primarily reflect royalties earned under the ADCETRIS collaboration with Takeda. In 2019, other collaboration and license agreement revenues included $20.0 million from BeiGene, Ltd., or BeiGene. BeiGene is a related party due to a common shareholder that has a representative or representatives serving on each company's respective Board of Directors. Contract balances and performance obligations We had no contract assets or liabilities as of December 31, 2020 and 2019. We recognized collaboration and license agreement revenues of $0, $33.6 million and $34.5 million during the years ended December 31, 2020, 2019, and 2018, respectively, that were included in deferred revenue as of the beginning of the respective years. On January 1, 2018, we adopted ASC Topic 606 applying the modified retrospective method transition option to all contracts that were not completed as of January 1, 2018. We recorded the following cumulative effect as of January 1, 2018: (dollars in thousands) Collaboration and license agreement revenues $ 10,281 Royalty revenues 22,230 Cost of royalty revenues $ (5,955) Accumulated deficit – (debit) credit $ 26,556 |
Operating leases
Operating leases | 12 Months Ended |
Dec. 31, 2020 | |
Leases [Abstract] | |
Operating leases | Operating leases We have operating leases for our office and laboratory facilities with terms that expire from 2021 through 2029. Upon adoption of ASC Topic 842--Leases on January 1, 2019, we recognized $35.2 million of operating lease liabilities and $34.7 million of operating lease right-of-use assets for our existing leases on our consolidated balance sheet. During the years ended December 31, 2020 and 2019, we recorded $7.2 million and $40.3 million, respectively, of right-of-use assets in exchange for lease liabilities, which has been treated as a non-cash operating activity. All of our significant 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 December 31, 2020. Supplemental operating lease information was as follows: Years ended December 31, (dollars in thousands, except term and rate ) 2020 2019 Operating lease cost $ 15,013 $ 13,590 Variable lease cost 3,937 2,958 Total lease cost $ 18,950 $ 16,548 Cash paid for amounts included in measurement of lease liabilities $ 14,265 $ 10,197 Weighted average remaining lease term (in years) 6.16 7.04 Weighted average discount rate 5.2 % 5.4 % Rent expense attributable to non-cancelable operating leases totaled approximately $16.6 million, $14.6 million, and $8.7 million for the years ended December 31, 2020, 2019, and 2018, respectively. Operating lease liabilities were recorded in the following captions of our consolidated balance sheet as follows: December 31, (dollars in thousands ) 2020 2019 Accrued liabilities and other $ 12,749 $ 9,445 Operating lease liabilities, long-term 61,884 67,607 Total $ 74,633 $ 77,052 As of December 31, 2020, future minimum lease payments under the lease agreements were as follows: (dollars in thousands) Years ending December 31, 2021 $ 16,337 2022 15,650 2023 15,030 2024 11,147 2025 7,510 Thereafter 22,656 Total future minimum lease payments 88,330 Less: imputed interest (13,697) Total $ 74,633 |
Acquisition of Cascadian
Acquisition of Cascadian | 12 Months Ended |
Dec. 31, 2020 | |
Business Combinations [Abstract] | |
Acquisition of Cascadian | Acquisition of Cascadian In 2018, we acquired all issued and outstanding shares of Cascadian, a clinical-stage biopharmaceutical company based in Seattle, Washington, for $10.00 per share in cash, or approximately $614.1 million, which was funded by an underwritten public offering as further described in Note 15. The acquisition of Cascadian expanded our late-stage pipeline, providing global rights to TUKYSA. The acquisition of Cascadian was accounted for as a business combination. During the year ended December 31, 2018, we incurred $8.5 million in acquisition-related costs, which were recorded in selling, general and administrative expenses. The purchase price allocation of the assets acquired and liabilities assumed based on their estimated fair values as of the acquisition date was as follows: (dollars in thousands) Cash and cash equivalents $ 15,919 Short-term and long-term investments 66,491 Prepaid expenses and other assets 2,215 Property and equipment 566 In-process research and development 300,000 Goodwill 274,671 Accounts payable and accrued liabilities (22,139) Deferred tax liability (23,653) Total purchase price $ 614,070 |
Fair Value
Fair Value | 12 Months Ended |
Dec. 31, 2020 | |
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 following table summarized the type of assets measured at fair value on a recurring basis by level within the fair value hierarchy: Fair value measurement using: (dollars in thousands) Quoted prices Other Significant Total December 31, 2020 Short-term investments—U.S. Treasury securities $ 2,000,996 $ — $ — $ 2,000,996 Long-term investments—U.S. Treasury securities 100,830 — — 100,830 Total $ 2,101,826 $ — $ — $ 2,101,826 December 31, 2019 Short-term investments—U.S. Treasury securities $ 536,493 $ — $ — $ 536,493 Long-term investments—U.S. Treasury securities 57,283 — — 57,283 Other non-current assets—equity securities 163,936 — — 163,936 Total $ 757,712 $ — $ — $ 757,712 Our short- and long-term investments portfolio predominantly 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 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 years ended December 31, 2020 and 2019, 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 December 31, 2020. Our debt securities consisted of the following: (dollars in thousands) Amortized Gross Gross Fair December 31, 2020 U.S. Treasury securities $ 2,101,801 $ 259 $ (234) $ 2,101,826 Contractual maturities (at date of purchase): Due in one year or less $ 1,791,399 $ 1,791,239 Due in one to two years 310,402 310,587 Total $ 2,101,801 $ 2,101,826 December 31, 2019 U.S. Treasury securities $ 593,565 $ 236 $ (25) $ 593,776 Contractual maturities (at date of purchase): Due in one year or less $ 466,439 $ 466,547 Due in one to two years 127,126 127,229 Total $ 593,565 $ 593,776 |
Investment and Other Income, Ne
Investment and Other Income, Net | 12 Months Ended |
Dec. 31, 2020 | |
Investments, Debt and Equity Securities [Abstract] | |
Investment and Other Income, Net | Investment and Other Income, Net Investment and other income, net consisted of the following: Years ended December 31, (dollars in thousands) 2020 2019 2018 Gain on equity securities $ 11,604 $ 50,124 $ 7,336 Investment and other income, net 7,245 11,771 6,316 Total investment and other income, net $ 18,849 $ 61,895 $ 13,652 Gain on equity securities includes the realized and unrealized holding gains and losses on our equity securities. In 2020, we sold our all our common stock holdings for $174.7 million. |
Inventories
Inventories | 12 Months Ended |
Dec. 31, 2020 | |
Inventory Disclosure [Abstract] | |
Inventories | Inventories Inventories consisted of the following: December 31, (dollars in thousands) 2020 2019 Raw materials $ 99,049 $ 78,285 Finished goods 17,087 7,647 Total $ 116,136 $ 85,932 |
Property and equipment
Property and equipment | 12 Months Ended |
Dec. 31, 2020 | |
Property, Plant and Equipment [Abstract] | |
Property and equipment | Property and equipment Property and equipment consisted of the following: December 31, (dollars in thousands) 2020 2019 Leasehold improvements $ 204,918 $ 154,606 Laboratory and manufacturing equipment 78,724 68,226 Building 23,341 23,341 Computers, software and office equipment 45,141 37,154 Furniture and fixtures 15,825 11,758 Land 4,771 4,771 372,720 299,856 Less: accumulated depreciation and amortization (176,020) (144,365) Total $ 196,700 $ 155,491 Depreciation and amortization expenses on property and equipment totaled $36.0 million, $23.8 million, and $25.3 million for the years ended December 31, 2020, 2019, and 2018, respectively. Leasehold improvements included $24.5 million and $62.2 million of construction in process at December 31, 2020 and 2019, respectively. |
Accrued liabilities
Accrued liabilities | 12 Months Ended |
Dec. 31, 2020 | |
Payables and Accruals [Abstract] | |
Accrued liabilities | Accrued liabilities Accrued liabilities consisted of the following : December 31, (dollars in thousands) 2020 2019 Employee compensation and benefits $ 96,902 $ 74,835 Clinical trial and related costs 69,756 37,418 Contract manufacturing 20,765 13,866 Gross-to-net deductions and third-party royalties 52,565 37,662 Operating lease liability, current 12,749 9,445 Collaborator contract liability – short-term 30,130 — Professional services and other 27,204 33,839 Total $ 310,071 $ 207,065 |
Income taxes
Income taxes | 12 Months Ended |
Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |
Income taxes | Income taxes Our pre-tax income (loss) by jurisdiction consisted of the following: Years ended December 31, (dollars in thousands) 2020 2019 2018 U.S. $ 613,054 $ (160,189) $ (226,626) Foreign 2,647 1,539 (19,720) Total $ 615,701 $ (158,650) $ (246,346) A reconciliation of the federal statutory income tax rate to the effective income tax rate is as follows: Years ended December 31, 2020 2019 2018 Statutory federal income tax rate 21.0 % (21.0) % (21.0) % Tax credits (5.4) (11.0) (6.0) Foreign rate differential — — (8.0) State income taxes and other 1.5 (4.7) (3.7) Valuation allowance (8.4) 37.1 44.0 Stock compensation (8.4) (6.4) (3.2) Non-deductible asset basis — 6.0 — Worthless stock deduction — — (12.1) Effective tax rate 0.3 % 0.0 % (10.0) % For the year ended December 31, 2020, we recorded a provision for income taxes of $2.0 million, consisting primarily of $3.7 million of current state taxes offset by a net $1.7 million deferred foreign tax benefit primarily related to the release of a valuation allowance on our foreign deferred tax asset for net operating losses. We utilized net operating loss carryforwards to reduce any federal tax liability, and we incurred state tax liabilities of $3.7 million due to certain states with current limitations on the utilization of net operating losses. In 2019, we did not record any income tax expense or benefit due to a tax loss position. In 2018, we recognized a deferred tax liability of $23.7 million on acquired intangible assets in connection with the acquisition of Cascadian. As a result, we recorded an income tax benefit of $23.7 million for the release of valuation allowance on our existing U.S. deferred tax assets as a result of the offset of deferred tax liabilities established for intangible assets from the acquisition. The foreign rate differential in the table above reflects the effect of operations in jurisdictions with tax rates that differ from the rate in the U.S. The change in foreign rate differential from 2018 to 2019 was primarily due to the one-time impact of foreign entity restructuring in 2018. As of December 31, 2020, unremitted earnings of our foreign subsidiaries will be retained indefinitely by the foreign subsidiaries for continuing investment. If foreign earnings were to be repatriated to the U.S., we could be subject to additional state income and withholding taxes. Our net deferred tax assets consisted of the following: December 31, (dollars in thousands) 2020 2019 Deferred tax assets: Net operating loss carryforwards $ 228,041 $ 331,124 Foreign net operating loss carryforwards 8,341 3,527 Tax credit carryforwards 224,233 193,552 Share-based compensation 33,315 34,869 Allowance and accruals 29,355 26,625 Operating lease liabilities 16,596 18,597 Inventory 19,402 3,815 Capitalized research and development 4,139 4,732 Depreciation — 9,430 Other — 1,133 Total deferred tax assets 563,422 627,404 Less: valuation allowance (489,519) (536,316) Total deferred tax assets, net of valuation allowance 73,903 91,088 Deferred tax liability: Right-of-use assets (13,647) (17,125) Intangibles and amortization (46,018) (50,725) Depreciation (10,215) — Unrealized gain on available-for-sale securities — (20,064) Other (1,970) (3,174) Net deferred tax assets $ 2,053 $ — Our deferred tax assets primarily consist of net operating loss (NOL) carryforwards, tax credit carryforwards, share-based compensation, allowance and accruals, operating lease liabilities, inventory, and capitalized research and development expense. Realization of deferred tax assets is dependent upon a number of factors, including future earnings, the timing and amount of which is uncertain. The assessment regarding whether a valuation allowance is required considers the evaluation of both positive and negative evidence when concluding whether it is more likely than not that deferred tax assets are realizable. Based upon a review of available evidence, we determined that it is not more likely than not that the U.S. deferred tax assets will be realized, and therefore the deferred tax assets have been fully offset by a valuation allowance. During the year ended December 31, 2020, we released $2.1 million of valuation allowance on our foreign NOL carryforward deferred tax asset. At December 31, 2020, we had gross federal NOL carryforwards of $971.0 million, of which $391.2 million may be carried forward indefinitely and $579.8 million of which expire from 2021 to 2037 if not utilized, gross state NOL carryforwards of $367.7 million, gross foreign NOL carryforwards of $42.3 million and tax credit carryforwards of $247.3 million expiring from 2021 to 2040. Utilization of the NOL and tax credit carryforwards may be subject to a substantial annual limitation in the event of a change in ownership as set forth in Section 382 of the Internal Revenue Code of 1986, as amended. We have evaluated ownership changes through the year ended December 31, 2019 and believe that it is likely that utilization of its NOLs would not be limited under Section 382 as of December 31, 2019. It is possible that there has been or may be a change in ownership after this date, which would limit our ability to utilize our NOLs. Any limitation may result in the expiration of the NOLs and tax credit carryforwards before utilization. The valuation allowance decreased by $46.8 million in 2020, increased by $58.5 million in 2019, and increased by $113.3 million in 2018, which was mostly related to the changes in our deferred tax asset balances. The 2020 decrease in the valuation allowance is primarily due to the current year net operating loss utilization, partially offset by tax credit generation. The 2019 increase in the valuation allowance is related to the loss, tax credits generated, and other activity. The 2018 increase in the valuation allowance included a $143.3 million increase related to the loss, tax credits and other activity in 2018, offset by a $23.7 million decrease for release of valuation allowance related to the deferred tax assets and liabilities acquired from Cascadian and a $6.3 million decrease due to the adoption of ASC Topic 606. The financial statement recognition of the benefit for a tax position is dependent upon the benefit being more likely than not to be sustainable upon audit by the applicable taxing authority. If this threshold is met, the tax benefit is then measured and recognized at the largest amount that is greater than 50% likely of being realized upon ultimate settlement. A reconciliation of the beginning and ending amount of unrecognized tax benefits is as follows: Years ended December 31, (dollars in thousands) 2020 2019 2018 Balance at January 1 $ 24,018 $ 20,706 $ 18,172 Increase (decrease) related to prior year tax positions (4,008) — 108 Increase related to current year tax positions 3,068 3,312 2,426 Balance at December 31 $ 23,078 $ 24,018 $ 20,706 We do not anticipate any significant changes to our unrecognized tax positions or benefits during the next twelve months. Interest and penalties related to the settlement of uncertain tax positions, if any, will be reflected in income tax expense. Tax years 2001 to 2020 remain subject to future examination for federal and foreign income taxes. |
Collaboration and license agree
Collaboration and license agreements | 12 Months Ended |
Dec. 31, 2020 | |
Collaboration Arrangement Disclosure [Abstract] | |
Collaboration and license agreements | Collaboration and license agreements We have collaboration and license agreements with a number of pharmaceutical and biotechnology companies. Revenues recognized under these agreements are disclosed in Note 2. These agreements generally may be terminated due to material and uncured breaches, insolvency of either party, mutual written consent, unilateral decision of one or either party upon prior written notice, expiration of payment obligations, cessation of development or commercialization of the products, and/or challenges to patents which are subject to the related agreement. Each agreement is discussed in more detail in the following sections. Takeda ADCETRIS collaboration The Takeda ADCETRIS collaboration provides for the global co-development of ADCETRIS and the commercialization of ADCETRIS by Takeda in its territory. We have commercial rights for ADCETRIS in the U.S. and its territories and in Canada. Takeda has commercial rights in the rest of the world. Under the collaboration, we and Takeda can each conduct development activities and equally co-fund the cost of certain mutually agreed development activities. Costs associated with co-development activities are included in research and development expense. We recognize payments received from Takeda, including progress-dependent development and regulatory milestone payments, reimbursement for drug supplied, and net development cost reimbursement payments, as collaboration and license agreement revenues upon transfer of control of the goods or services over the development period. When the performance of development activities under the collaboration results in us making a reimbursement payment to Takeda, that payment reduces collaboration and license agreement revenues. In addition, we recognize royalty revenues, where royalties are based on a percentage of Takeda’s net sales of ADCETRIS in its licensed territories, with percentages ranging from the mid-teens to the mid-twenties based on annual net sales tiers, and sales-based milestones. Takeda bears a portion of third-party royalty costs owed on its sales of ADCETRIS, which is included in royalty revenues. Astellas PADCEV collaboration We have a collaboration agreement with Agensys, Inc., which subsequently became an affiliate of Astellas, to jointly research, develop and commercialize ADCs for the treatment of several types of cancer. The collaboration encompasses combinations of our ADC technology with fully-human antibodies developed by Astellas to proprietary cancer targets. Under this collaboration, we and Astellas are co-funding all development costs for PADCEV. We rely on Astellas to supply PADCEV for commercial sales and for our clinical trials, and Astellas oversees the manufacturing supply chain for PADCEV. Costs associated with co-development activities are included in research and development expense and amounted to $99.3 million, $76.8 million, and $54.9 million for the years ended December 31, 2020, 2019, and 2018, respectively. In 2018, we and Astellas entered into a joint commercialization agreement to govern the global commercialization of PADCEV: • In the U.S., we and Astellas jointly promote PADCEV. We record sales of PADCEV in the U.S. and are responsible for all U.S. distribution activities. The companies each bear the costs of their own sales organizations in the U.S., equally share certain costs associated with commercializing PADCEV in the U.S., and equally share in any profits realized in the U.S. We and Astellas launched PADCEV in the U.S. in December 2019. Gross profit share payments owed to Astellas in the U.S. are recorded in cost of sales and totaled $104.6 million during the year ended December 31, 2020. • Outside the U.S., we have commercialization rights in all countries in North and South America, and Astellas has commercialization rights in the rest of the world, including Europe, Asia, Australia and Africa. The agreement is intended to provide that we and Astellas will effectively equally share in costs incurred and any profits realized in all of these markets. Cost and profit sharing in Canada, the United Kingdom, Germany, France, Spain and Italy will be based on product sales and costs of commercialization. In the remaining markets, the commercializing party will bear costs and will pay the other party a royalty rate applied to net sales of the product based on a rate intended to approximate an equal profit share for both parties. Either party may opt out of co-development and profit-sharing under the collaboration agreement in return for receiving milestones and royalties from the continuing party. Astellas or its affiliates are responsible for manufacturing PADCEV for development and commercial use. However, we are responsible for packaging and labeling in countries in which we sell PADCEV. In addition, if the parties determine that a second source is required, we will be responsible for establishing such second source whether internally or through a third party. Genmab tisotumab vedotin collaboration We have an agreement with Genmab to develop and commercialize ADCs for the treatment of several types of cancer, under which we previously exercised a co-development option for tisotumab vedotin. In October 2020, we and Genmab entered into a joint commercialization agreement to govern the global commercialization of tisotumab vedotin, if we are successful in obtaining any regulatory approvals of tisotumab vedotin: • In the U.S., we and Genmab will co-promote tisotumab vedotin. We will record sales of tisotumab vedotin in the U.S. and are responsible for leading U.S. distribution activities. The companies will each hire and maintain 50% of the sales representatives and medical science liaisons, equally share those and certain other costs associated with commercializing tisotumab vedotin in the U.S., and equally share in any profits realized in the U.S. • Outside the U.S., we have commercialization rights in the rest of the world except for Japan, where Genmab has commercialization rights. In Europe, China, and Japan, we and Genmab equally share 50% of the costs associated with commercializing tisotumab vedotin as well as any profits realized in these markets. In markets outside the U.S. other than Europe, China, and Japan, aside from certain costs specified in the agreement, we are solely responsible for all costs associated with commercializing tisotumab vedotin and will pay Genmab a royalty based on a percentage of aggregate net sales ranging from the mid-teens to mid-twenties. In February 2021, a BLA for tisotumab vedotin was submitted to the FDA seeking accelerated approval for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Costs associated with co-development activities are included in research and development expense and amounted $50.1 million, $48.5 million, and $33.8 million for the years ended December 31, 2020, 2019, and 2018, respectively. Either party may opt out of co-development and profit-sharing under the collaboration agreement in return for receiving milestones and royalties from the continuing party. Either party may also opt out of co-development and profit-sharing under the collaboration agreement in return for receiving milestones and royalties from the continuing party. The opt out provisions of the collaboration agreement may also be applied to the joint commercialization agreement. In addition, Genmab may elect to opt out of co-promotion of tisotumab vedotin in the United States by providing us with prior written notice. Merck LV and TUKYSA license and collaboration agreements, and stock purchase agreement In September 2020, we entered into two license and collaboration agreements, and a stock purchase agreement, with subsidiaries of Merck. Under one of the license and collaboration agreements, referred to as the LV Agreement, we are pursuing a broad joint development program evaluating ladiratuzumab vedotin, or LV, as monotherapy and in combination settings, including with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in triple-negative breast cancer, hormone receptor-positive breast cancer and other LIV-1-expressing solid tumors. Pursuant to the LV Agreement, we granted to Merck a co-exclusive worldwide development and commercialization license for LV, and agreed to jointly develop and commercialize LV on a worldwide basis. We received an upfront cash payment of $600.0 million, and we are eligible to receive up to $850.0 million in milestone payments upon the initiation of certain clinical trials and regulatory approval in certain major markets, and up to an additional $1.75 billion in milestone payments upon the achievement of specified annual global net sales thresholds of LV. Each company is responsible for 50% of global costs to develop and commercialize LV and will receive 50% of potent ial future profits. In connection with the LV Agreement, we entered into a stock purchase agreement with Merck, referred to as the Purchase Agreement, pursuant to which Merck purchased 5,000,000 newly-issued shares of our common stock, at a purchase price of $200 per share, for an aggregate purchase price of $1.0 billion. The fair market value of 5,000,000 shares of our common stock was $749.9 million, based on the closing price of the last trading day prior to the Purchase Agreement being executed. We recorded the fair market value of the shares issued in stockholders’ equity on our consolidated balance sheet upon closing of the sale of shares pursuant to the Purchase Agreement in October 2020. We accounted for the associated premium of $250.1 million as a freestanding equity-linked instrument under ASC 815, and determined it to be variable consideration attributable to the total transaction price related to the LV license. Accordingly, we recognized the premium in collaboration and license agreement revenues for the year ended December 31, 2020, upon closing of the sale of shares pursuant to the Purchase Agreement. Under the other license and collaboration agreement, referred to as the TUKYSA Agreement, we granted Merck exclusive rights to commercialize TUKYSA in Asia, the Middle East and Latin America and other regions outside of the U.S., Canada and Europe. Pursuant to the TUKYSA Agreement, Merck is responsible for marketing applications for approval in its territory, supported by the positive results from the HER2CLIMB clinical trial. We retained commercial rights in the U.S., Canada and Europe, where we will record sales. Merck is also co-funding a portion of the TUKYSA global development plan, which encompasses several ongoing and planned trials across HER2-positive cancers. We will continue to lead ongoing TUKYSA global development operational execution. Merck will solely fund and conduct country-specific clinical trials necessary to support anticipated regulatory applications in its territories. We received an upfront cash payment from Merck of $125.0 million and also received $85.0 million in prepaid research and development funding to be applied to Merck’s global development cost sharing obligations. We are eligible to receive progress-dependent milestone payments of up to $65.0 million, and are entitled to receive tiered royalties on sales of TUKYSA by Merck that begin in the low twenty percent range and escalate based sales volume by Merck in its territory. We owe a portion of any non-royalty payments received from sublicensing TUKSYA rights to a technology licensor, as well as a low double-digit royalty based on net sales of TUKYSA by us, and will owe a single-digit royalty based on net sales of TUKYSA by Merck in its territories. We determined that these agreements are within the scope of ASC 808. Pursuant to ASC 808, we considered other authoritative guidance for distinct units of account related to these agreements, including ASC 606. Our performance obligations within the scope of ASC 606 consisted of the delivery of the LV license and transfer of regulatory information to enable the LV collaboration, the delivery of the TUKYSA license and transfer of regulatory materials for use by Merck in its territory, and supply of commercial TUKYSA inventory to Merck for use in its territory. The LV license and TUKYSA license are functional intellectual property and distinct from the other promises made under the contract. Since we also determined that Merck can benefit from the LV license and the TUKYSA licenses at the time of conveyance, the related performance obligations were satisfied at that point in ti me. Therefore, we recognized license revenue related to the upfront payments under ASC 606 in collaboration and license agreement revenues during the year ended December 31, 2020. Potential development, regulatory, and sales-based milestones, and royalties, will be accounted for as variable transaction price related to the LV or TUKYSA licenses under ASC 606. Given the uncertain nature of these payments, we determined they were fully constrained as of December 31, 2020 and not included in the transaction price. We will re-evaluate the transaction price at each reporting period as uncertain events are resolved or other changes in circumstances occur. We and Merck share equally in LV global development costs, and Merck is co-funding a portion of the TUKYSA global development plan. We consider the collaborative activities associated with the global development and commercialization of LV, and the global development of TUKYSA, to be units of account within the scope of ASC 808. We recognize development cost sharing proportionately with the performance of the underlying activities, and record Merck’s reimbursement of our expenses as a reduction of research and development expenses. Reimbursements from Merck for the LV Agreement and TUKYSA Agreement were not material during the y ear ended December 31, 2020. Merck’s remaining prepayment of $80.9 million towards the TUKYSA global development plan was recorded as a co-development liability in accrued liabilities and other or other long-term liabilities on our consolidated balance sheet as of December 31, 2020. As joint development expenses are incurred, we recognize the portion of Merck’s prepayment as a reduction of our research and development expenses on our consolidated statements of comprehensive income (loss). Sales of TUKYSA drug product supplied to Merck will be included in collaboration and license agreement revenues. Other collaboration and license agreements We have other collaboration and license agreements for our technology with a number of biotechnology and pharmaceutical companies. Under these agreements, we have granted research and commercial licenses to use our technology, most often in conjunction with the licensee's technology. In certain agreements, we also have agreed to conduct limited development activities and to provide other materials, supplies and services to our licensees during a specified term of the agreement. We typically 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. These amounts are recognized as revenue over the performance obligation period if the license is determined to not be distinct from other goods and services provided, or, if there is no performance obligation, upon transfer of control of the goods or services to the customer. We also are entitled to receive royalties on net sales of any resulting products incorporating our ADC technology. Our licensees are solely responsible for research, product development, manufacturing and commercialization of any product candidates under these agreements, which includes the achievement of the potential milestones. 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. |
In-license agreements
In-license agreements | 12 Months Ended |
Dec. 31, 2020 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
In-license agreements | In-license agreements We have in-licensed antibodies, targets and enabling technologies from pharmaceutical and biotechnology companies and academic institutions for use in ADCETRIS, its pipeline programs and ADC technology. Under the terms of two exclusive license agreements, we are required to pay royalties in the low single digits on net sales of ADCETRIS. In addition, we owed royalties in the low single digits on net sales of ADCETRIS under the terms of other non-exclusive licenses, which expired in 2018. We are a party to a license agreement in which we were granted an exclusive license to develop, manufacture and commercialize TUKYSA. We pay the licensor a portion of any non-royalty payments received from sublicensing TUKSYA rights, a low double-digit royalty based on net sales of TUKSYA by us, and a single-digit royalty based on net sales of TUKYSA by our sublicensees. The term of the license agreement expires on a country-by-country basis upon the later of the expiration of the last valid claim covering TUKYSA within that country or 10 years after the first commercial sale of TUKYSA within that country. Under the terms of in-license agreements related to our pipeline programs, we would potentially owe development, regulatory, and sales-based milestones, and royalties on net sales, as defined, of certain approved products. |
Commitments and contingencies
Commitments and contingencies | 12 Months Ended |
Dec. 31, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and contingencies | Commitments and contingencies We have certain non-cancelable obligations under various agreements, including supply agreements relating to the manufacture of ADCETRIS, PADCEV, TUKYSA, and our product candidates that contain annual minimum purchase commitments and other firm commitments when a binding forecast is provided. As of December 31, 2020, our future obligations related to supply and other agreements were as follows: (dollars in thousands) Years ending December 31, 2021 $ 141,130 2022 84,384 2023 61,680 2024 44,988 2025 33,816 Thereafter 128 Total $ 366,126 Non-cancelable obligations under these agreements do not include payments that are contingent upon achievement of certain progress-dependent milestones or royalties based on net sales of commercial products. These amounts have been excluded from the table because the events triggering the obligations have not yet occurred. See Note 3 for our future obligations related to operating leases as of December 31, 2020. |
Legal matters
Legal matters | 12 Months Ended |
Dec. 31, 2020 | |
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 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 is progressing with a hearing date scheduled starting June 14, 2021. 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. On March 25, 2020, a District of Delaware magistrate judge issued a stay of Daiichi Sankyo’s court action pending determination by the arbitrator of whether the suit should be heard in court or arbitration. On April 8, 2020, Daiichi Sankyo filed objections to the magistrate judge’s order. On October 27, 2020, the presiding District Court Judge overruled Daiichi Sankyo's objections and affirmed the magistrate judge's stay, and subsequently ordered the case to be administratively closed on November 13, 2020. 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. This action is seeking, 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. 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 Office seeking to have claims of the ‘039 Patent cancelled as unpatentable. As a result of these disputes, we have incurred and will continue to incur litigation expenses. In addition, from time to time, we may become involved in other lawsuits, claims and proceedings relating to the conduct of our business, including those pertaining to the defense and enforcement of our patent or other intellectual property rights and our contractual rights. These proceedings are costly and time consuming, and they may subject us to claims which may result in liabilities or require us to take or refrain from certain actions. Additionally, successful challenges to our patent or other intellectual property rights through these proceedings could result in a loss of rights in the relevant jurisdiction and may allow third parties to use our proprietary technologies without a license from us or our collaborators. |
Stockholders' equity
Stockholders' equity | 12 Months Ended |
Dec. 31, 2020 | |
Equity [Abstract] | |
Stockholders' equity | Stockholders’ equity In October 2020, we closed the sale of the shares pursuant to the Purchase Agreement, and issued 5,000,000 shares of our common stock to Merck at a purchase price of $200 per share, for proceeds of $1.0 billion. As a result, we recorded $749.9 million in stockholders’ equity on our consolidated balance sheet and recognized the $250.1 million premium attributed to the Purchase Agreement in collaboration and license agreement revenues for the year ended December 31, 2020. In July 2019, we completed an underwritten public offering of 8,214,286 shares of our common stock at a public offering price of $70.00 per share. The offering resulted in net proceeds to us of $548.7 million, after deducting underwriting discounts, commissions, and other offering expenses. The primary use of the net proceeds was to fund our ADCETRIS and PADCEV commercialization efforts and our research and development efforts, as well as general corporate purposes, including working capital. In February 2018, we completed an underwritten public offering of 13,269,230 shares of our common stock at a public offering price of $52.00 per share. The offering resulted in net proceeds to us of $658.2 million, after deducting underwriting discounts, commissions, and other offering expenses. The primary use of the net proceeds was to fund the acquisition of Cascadian. At December 31, 2020, shares of common stock reserved for future issuance are as follows: (in thousands) Stock options and RSUs outstanding 10,917 Shares available for future grant under the 2007 Equity Incentive Plan 8,624 Employee stock purchase plan shares available for future issuance 986 Total 20,527 |
Share-based compensation
Share-based compensation | 12 Months Ended |
Dec. 31, 2020 | |
Share-based Payment Arrangement [Abstract] | |
Share-based compensation | Share-based compensation 2007 Equity Incentive Plan Our 2007 Equity Incentive Plan, or the 2007 Plan, provides for the issuance of our common stock to employees, including our officers, directors and consultants and affiliates. The 2007 Plan was amended and restated in 2020 to reserve an additional 6,000,000 shares thereunder, such that an aggregate of 39,000,000 shares of our common stock were authorized for issuance as of December 31, 2020, and to extend the term of the 2007 Plan through May 2030 unless it is terminated earlier pursuant to its terms. Under the 2007 Plan, we may issue stock options (including incentive stock options and nonstatutory stock options), restricted stock, RSUs, stock appreciation rights and other similar types of awards. We have only issued options to purchase shares of common stock and RSUs under the 2007 Plan, including options and RSUs with time-based or performance-based vesting requirements. Performance-based vesting occurs upon achievement of pre-determined regulatory milestones, sales-based milestones, or market-based performance metrics. Incentive stock options under the 2007 Plan may be granted only to our employees. The exercise price of an incentive stock option or a nonstatutory stock option may not be less than 100% of the fair market value of the common stock on the date the option is granted and the options generally have a maximum term of ten years from the date of grant. Generally, options granted to employees under the 2007 Plan vest 25% one year after the grant date and thereafter ratably each month over the following thirty-six months. Generally, RSUs granted to employees vest 25% each year beginning one year after the grant date. Option and RSU grants to non-employee members of our board of directors vest over one year. The vesting of performance-based awards generally includes vesting upon achievement of pre-determined milestones or metrics and, in some cases, vesting upon achievement of pre-determined milestones or metrics in addition to the passage of time. The 2007 Plan provides for (i) the full acceleration of vesting of equity awards upon a change in control if the successor company does not assume, substitute or otherwise replace the equity awards upon the change in control; and (ii) the full acceleration of vesting of any equity awards if at the time of, immediately prior to or within twelve months after a change in control of the Company, the holder of such equity awards is involuntarily terminated without cause or is constructively terminated by the successor company that assumed, substituted or otherwise replaced such stock awards in connection with the change in control. Share-based compensation expense We recorded total share-based compensation expense of $147.2 million, $127.3 million, and $78.9 million for 2020, 2019, and 2018, respectively, including share-based compensation expense associated with our LTIPs. Share-based compensation included in research and development expenses was $72.7 million, $64.7 million, and $40.4 million for 2020, 2019, and 2018, respectively, and share-based compensation included in sales, general, and administrative expenses was $74.5 million, $62.6 million, and $38.5 million for 2020, 2019, and 2018, respectively. We recognized a tax benefit of $55.7 million related to share-based compensation expense for 2020. No tax benefit was recognized for 2019 and 2018 since there is no taxable income for those years and a valuation allowance is available to offset all potential tax benefits associated with its deferred tax assets. Valuation assumptions We calculate the fair value of each option award on the date of grant using the Black-Scholes option pricing model. The following weighted-average assumptions were used for the periods indicated: 2007 Plan Employee Stock Purchase Plan Years ended December 31, Years ended December 31, 2020 2019 2018 2020 2019 2018 Risk-free interest rate 0.3 % 1.5 % 2.8 % 1.3 % 2.2 % 1.7 % Expected lives (in years) 5.7 5.6 5.6 0.5 0.5 0.5 Expected dividend 0 % 0 % 0 % 0 % 0 % 0 % Expected volatility 44 % 44 % 42 % 47 % 43 % 36 % The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the time of grant for the expected life of the award. Our computation of expected life was determined based on our historical experience with similar awards, giving consideration to the contractual terms of the share-based awards, vesting schedules and expectations of future employee behavior. A forfeiture rate is estimated at the time of grant to reflect the amount of awards that are granted but are expected to be forfeited by the award holder prior to vesting. The estimated forfeiture rate applied to these amounts is derived from historical stock award forfeiture behavior. We have never paid cash dividends and do not currently intend to pay cash dividends. Our computation of expected volatility is based on the historical volatility of our stock price. The fair value of RSUs is determined based on the closing price of our common stock on the date of grant. Stock option activity A summary of stock option activity is as follows : Shares Weighted- Weighted-average Aggregate Balance at December 31, 2019 9,560,510 $ 47.62 Granted 871,939 $ 159.69 Exercised (2,258,503) $ 35.77 Forfeited/expired (292,693) $ 69.50 Balance at December 31, 2020 7,881,253 $ 62.60 6.05 $ 887,226 Expected to vest 7,668,287 $ 61.31 5.98 $ 873,149 Options exercisable 5,236,758 $ 46.10 4.98 $ 675,746 The weighted average grant-date fair values of options granted with exercise prices equal to market were $64.66 , $30.51, and $30.77 for the years ended December 31, 2020, 2019, and 2018, respectively. The aggregate intrinsic value in the table above is calculated as the difference between the exercise price of the underlying options and the quoted price of our common stock for all options that were in-the-money at December 31, 2020. The aggregate intrinsic value of options exercised was $271.0 million during 2020, $128.4 million during 2019, and $73.3 million during 2018, determined as of the date of option exercise. As of December 31, 2020, there was approximately $52.4 million of total unrecognized compensation cost related to unvested options, as adjusted for expected forfeitures. That cost is expected to be recognized over a weighted-average period of 1.22 years . We utilize newly issued shares to satisfy option exercises. RSU activity A summary of RSU activ ity, excluding performance-based RSUs, is as f ollows: Share Weighted- Non-vested at December 31, 2019 2,991,562 $ 68.66 Granted 816,486 $ 159.51 Vested (1,201,084) $ 60.90 Forfeited (249,458) $ 78.08 Non-vested at December 31, 2020 2,357,506 $ 105.50 The weighted average grant-date fair values of RSUs granted were $159.51 , $75.58, and $70.78 for the years ended December 31, 2020, 2019, and 2018, respectively. The total fair value of RSUs that vested during 2020, 2019, and 2018 (measured on the date of vesting) was $187.1 million , $67.1 million, and $42.4 million, respectively. As of December 31, 2020, there was approximately $144.7 million of total unrecognized compensation cost related to non-vested RSU awards, as adjusted for expected forfeitures. That cost is expected to be recognized over a weighted-average period of 1.60 years. We utilize newly issued shares for RSUs that vest. LTIP and performance-based awards activity We have various LTIPs, which contain performance-based equity compensation, and have granted other performance-based awards to certain executive officers. During 2020, an LTIP milestone was achieved related to FDA approval of TUKYSA based on our HER2CLIMB trial, which triggered vesting of performance-based stock awards previously granted to eligible participants, and an RSU grant to eligible participants. The vesting of the previously granted performance-based stock awards related to this LTIP is included in the table below. The second tranche grant upon milestone achievement and time-based vesting of these awards is included in the " RSU activity " table above. During 2019, an LTIP milestone was achieved related to the FDA approval of PADCEV based on our EV-201 trial, which triggered a cash payment to eligible participants and an RSU grant to certain eligible participants. The vesting of grants made under that LTIP is time-based and is included in the “RSU activity” table above. During 2018, an LTIP milestone was achieved related to the FDA approval of an ADCETRIS indication, which triggered a cash payment to eligible participants and commenced vesting of stock options related to that LTIP. The vesting for that LTIP is time-based and is included in the “Stock option activity” table above. A summary of activity related to our performance-based RSUs and LTIPs is as follows: Share Weighted- Non-vested at December 31, 2019 616,643 $ 95.05 Granted 365,070 $ 151.93 Vested (240,667) $ 58.14 Forfeited (62,469) $ 96.89 Non-vested at December 31, 2020 678,577 $ 132.80 As of December 31, 2020, the estimated unrecognized compensation cost related to all LTIPs and performance-based awards was approximately $74 million. Employee Stock Purchase Plan |
Employee benefit plan
Employee benefit plan | 12 Months Ended |
Dec. 31, 2020 | |
Retirement Benefits [Abstract] | |
Employee benefit plan | Employee benefit plan We have a 401(k) Plan for all of our U.S. employees. Eligible employees may contribute through payroll deductions, and we may match the employees’ 401(k) contributions, at our discretion and not to exceed a prescribed annual limit. Under this matching program, we contributed $18.0 million in 2020, $11.9 million in 2019, and $7.7 million in 2018. |
Quarterly financial data (unaud
Quarterly financial data (unaudited) | 12 Months Ended |
Dec. 31, 2020 | |
Quarterly Financial Information Disclosure [Abstract] | |
Quarterly financial data (unaudited) | Quarterly financial data (unaudited) The unaudited quarterly financial information should be read in conjunction with our financial statements and related notes included elsewhere in this report. We believe that the following unaudited information reflects all normal recurring adjustments necessary for a fair presentation of the information for the periods presented. The operating results for any quarter are not necessarily indicative of results for any future period. The following table contains selected unaudited financial data for each of the indicated periods: Three months ended (dollars in thousands, except per share data) March 31, June 30, September 30, December 31, 2020 Total revenues $ 234,514 $ 277,998 $ 1,061,731 $ 601,293 Net income (loss) $ (168,402) $ (21,190) $ 636,167 $ 167,095 Net income (loss) per share - basic $ (0.98) $ (0.12) $ 3.65 $ 0.93 Net income (loss) per share - diluted $ (0.98) $ (0.12) $ 3.50 $ 0.90 2019 Total revenues $ 195,199 $ 218,447 $ 213,263 $ 289,804 Net income (loss) $ (13,329) $ (79,238) $ (91,913) $ 25,830 Net income (loss) per share - basic $ (0.08) $ (0.49) $ (0.55) $ 0.15 Net income (loss) per share - diluted $ (0.08) $ (0.49) $ (0.55) $ 0.14 |
Net income (loss) per share
Net income (loss) per share | 12 Months Ended |
Dec. 31, 2020 | |
Earnings Per Share [Abstract] | |
Net income (loss) per share | Net income (loss) per share Basic net income (loss) per share is computed by dividing net income (loss) by the weighted average number of common shares outstanding during the period. Diluted net income (loss) per share is computed by dividing net income (loss) by the weighted average number of common shares and potentially dilutive common shares outstanding during the period. Potentially dilutive common shares include incremental common shares resulting the assumed vesting of restricted stock units and the assumed exercise of outstanding stock options, calculated using the treasury stock method. The following table shows the calculation of basic and diluted net income (loss) per share: Years ended December 31, (dollars in thousands, except per share amounts) 2020 2019 2018 Net income (loss) $ 613,670 $ (158,650) $ (222,693) Weighted average common shares outstanding - basic 174,834 165,498 157,655 Effect of potentially dilutive common shares 7,453 — — Weighted average common shares outstanding - diluted 182,287 165,498 157,655 Net income (loss) per share - basic $ 3.51 $ (0.96) $ (1.41) Net income (loss) per share - diluted $ 3.37 $ (0.96) $ (1.41) We excluded the potential shares of common stock from the computation of diluted net income (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: Years ended December 31, (in thousands) 2020 2019 2018 Stock options and RSUs 356 12,774 13,439 |
Organization and Summary of S_2
Organization and Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Basis of presentation | Basis of presentation |
Use of estimates | Use of estimates The preparation of financial statements in accordance with GAAP requires us to make estimates, assumptions, and judgments that affect the amounts reported in the consolidated financial statements and accompanying notes. Actual results could differ from those estimates. Estimates include those used for revenue recognition, valuation of investments, inventory valuation, business combinations, accrued liabilities (including those related to the long-term incentive plans, clinical trials and contingencies), stock option valuation, and valuation allowance for deferred tax assets. |
Reclassifications | Reclassifications We combined cost of sales with cost of royalty revenues during the current year and reclassified the prior years cost of royalty revenues on our consolidated statements of comprehensive income (loss), to conform to the current year presentation. This reclassification had no effect on our net cash used by operating activities or our consolidated statements of comprehensive income (loss). |
Cash and cash equivalents | Cash and cash equivalents We consider all highly liquid investments with maturities of three months or less at the date of acquisition to be cash equivalents. |
Non-cash activities | Non-cash activities |
Investments | Investments We held certain equity securities that we acquired in connection with strategic agreements, which were reported at estimated fair value. Changes 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 adopted Accounting Standards Update, or ASU, “ASU 2016-01, Financial Instruments: Overall” on January 1, 2018, which addressed certain aspects of recognition, measurement, presentation and disclosure of financial instruments, including that changes in the fair value of equity securities be recorded in income or loss rather than accumulated other comprehensive income or loss in stockholders’ equity. We used the modified retrospective method transition option and recognized a $64.1 million cumulative effect of initially applying this ASU as an adjustment to decrease the opening accumulated deficit at January 1, 2018. 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 and 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, 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, net. Interest and dividends earned are included in investment and other income, net. We classify 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, net. |
Fair value of financial instruments | Fair value of financial instruments The recorded amounts of certain financial instruments, including cash and cash equivalents, interest receivable, accounts receivable, accounts payable and accrued liabilities approximate fair value due to their relatively short maturities. Investments that are classified as available-for-sale are recorded at estimated fair value. The estimated fair value for securities held is determined using quoted market prices, broker or dealer quotations, or alternative pricing sources with reasonable levels of price transparency. |
Leases | Leases We adopted Accounting Standards Codification, or ASC, Topic 842--Leases on January 1, 2019, resulting in a change to our accounting policy for leases. We recorded a liability to make lease payments and a right-of-use asset representing our right to use the underlying assets for the applicable lease terms in our consolidated balance sheet. We used the modified retrospective method transition option. Accordingly, 2018 comparative information has not been adjusted and continues to be reported under previous accounting standards. We elected the "package of practical expedients", which permitted us not to reassess our prior conclusion about lease identification, lease classification and initial direct cost. We also elected the practical expedient to not separate lease and non-lease components for our real estate leases, and elected the short-term lease recognition exemption for our short-term leases, which allows us not to recognize lease liabilities and right-of-use assets on our consolidated balance sheet for leases with an original term of twelve months or less. The adoption of the standard had a material impact on our consolidated balance sheet, did not have an impact on our consolidated statement of comprehensive income (loss), and there was no cumulative-effect adjustment to the opening accumulated deficit in the period of adoption. See Note 3 for additional information. |
Inventories | Inventories We consider regulatory approval of product candidates to be uncertain. Accordingly, we charge manufacturing costs to research and development expense until such time as a product has received regulatory approval for commercial sale. Production costs for our marketed products are capitalized into inventory. Inventory that is deployed for clinical, research or development use is charged to research and development expense when it is no longer available for commercial sales. Production costs for our other product candidates continue to be charged to research and development expense. We value our inventories at the lower of cost or market value. Cost is determined on a specific identification basis. Inventory includes the cost of materials, third-party contract manufacturing and overhead associated with the production of our commercialized products. In the event that we identify excess, obsolete or unsalable inventory, its value is written down to net realizable value. |
Property and equipment | Property and equipment Property and equipment are stated at cost. Land is not depreciated, while all other property and equipment are depreciated using the straight-line method over the estimated useful lives of the assets, which are generally as follows: Years Building 30 Laboratory and manufacturing equipment 5-15 Furniture and fixtures 5 Computers, software and office equipment 3 |
Business combinations, including acquired in-process research and development, and goodwill | Business combinations, including acquired in-process research and development and goodwill We account for business combinations using the acquisition method, recording the acquisition-date fair value of total consideration over the acquisition-date fair value of net assets acquired as goodwill. Fair value is typically estimated using an income approach based on the present value of future discounted cash flows. The significant estimates in the discounted cash flow model primarily include the discount rate, and rates of future revenue and expense growth and/or profitability of the acquired business. The discount rate considers the relevant risk associated with business-specific characteristics and the uncertainty related to the ability to achieve the projected cash flows. We may record adjustments to the fair values of assets acquired and liabilities assumed within the measurement period (up to one year from the acquisition date). In-process research and development assets are accounted for as indefinite-lived intangible assets and maintained on the balance sheet until either the underlying project is completed or the asset becomes impaired. If the project is completed, which generally occurs when FDA approval is obtained, the carrying value of the related intangible asset is amortized to cost of sales on a straight-line basis over the estimated useful life of the asset beginning in the period in which the project is completed. We periodically evaluate when facts or circumstances indicate that the carrying value of these assets may not be recoverable. If the asset becomes impaired or is abandoned, the carrying value of the related intangible asset is written down to its fair value and an impairment charge is recorded in the period in which the impairment occurs. We evaluate indefinite-lived intangible assets and goodwill for impairment annually, as of October 1, or more frequently when events or circumstances indicate that impairment may have occurred. As part of the impairment evaluation, we may elect to perform an assessment of qualitative factors. If this qualitative assessment indicates that it is more likely than not that the fair value of the indefinite-lived intangible asset or the reporting unit (for goodwill) is less than its carrying value, we then would proceed with the quantitative impairment test to compare the fair value to the carrying value and record an impairment charge if the carrying value exceeds the fair value. Acquisition-related costs, including banking, legal, accounting, valuation, and other similar costs, are expensed in the period in which the costs are incurred. The results of operations of the acquired business are included in the consolidated financial statements from the acquisition date. |
Intangible assets, net | Intangible assets, netOur intangible assets are primarily comprised of acquired TUKYSA technology from the acquisition of Cascadian Therapeutics, Inc. in 2018. Upon FDA approval and commercial launch of TUKYSA in April 2020, we classified in-process research and development costs related to the acquired TUKYSA technology as finite-lived intangible assets. |
Impairment of long-lived assets | Impairment of long-lived assets (other than acquired in-process research and development and goodwill)We assess the impairment of long-lived assets, including intangible assets and property and equipment, whenever events or changes in business circumstances indicate that the carrying amounts of the assets may not be fully recoverable. When such events occur, we determine whether there has been an impairment in value by comparing the asset’s carrying value with its fair value, as measured by the anticipated undiscounted net cash flows of the asset. If an impairment in value exists, the asset is written down to its estimated fair value. |
Revenue recognition | Revenue recognition - Net product sales We adopted ASC Topic 606--Revenue from Contracts with Customers on January 1, 2018, resulting in a change to our accounting policy for revenue recognition. We used the modified retrospective method transition option and recognized the cumulative effect of initially applying ASC Topic 606 as an adjustment to decrease the opening accumulated deficit at January 1, 2018. See Note 2 for additional information. We sell ADCETRIS, PADCEV and TUKYSA through a limited number of specialty distributors and specialty pharmacies. We and our collaboration partner Astellas jointly promote PADCEV in the U.S. Under the joint promotion in the U.S., we record net sales of PADCEV and are responsible for all distribution through a limited number of specialty distributors. 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 title and risk of loss pass. 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. We have applied a portfolio approach as a practical expedient for estimating net product sales. 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, distributors process a chargeback to us for the difference between wholesale acquisition cost and the applicable discounted price. 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. 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. 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 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. For those agreements, revenue is recognized using a proportional performance model, representing the transfer of goods or services as activities are performed over the term of the agreement. Upfront payments are also 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. |
Research and development expenses | Research and development expenses Research and development, or R&D, expenses consist of salaries, benefits and other headcount-related costs of our R&D staff, preclinical activities, clinical trials and related manufacturing costs, lab supplies, contract and outside service fees and facilities and overhead expenses for research, development and preclinical studies focused on drug discovery, development and testing. R&D activities are expensed as incurred. Clinical trial expenses are a significant component of research and development expenses, and we outsource a significant portion of these costs to third parties. Third-party clinical trial expenses include investigator fees, site costs, clinical research organization costs, and costs for central laboratory testing and data management. Costs associated with activities performed under co-development collaborations are reflected in R&D expense. In-licensing fees, milestones, maintenance fees and other costs to acquire technologies utilized in R&D for product candidates that have not yet received regulatory approval and that are not expected to have alternative future use are expensed when incurred. Non-refundable advance payments for goods or services that will be used or rendered for future R&D activities are capitalized and recognized as expense as the related goods are delivered or the related services are performed. This results in the temporary deferral of recording expense for amounts incurred for research and development activities from the time payments are made until the time goods or services are provided. |
Advertising | Advertising |
Concentration of credit risk | Concentration of credit risk Cash, cash equivalents and investments are invested in accordance with our investment policy. The policy includes guidelines for the investment of cash reserves and is reviewed periodically to minimize credit risk. Most of our investments are in U.S. Treasury securities and are not federally insured. We have accounts receivable from the sale of our products from a small number of distributors, and from our collaborators. We do not require collateral on amounts due from our distributors or our collaborators and are therefore subject to credit risk. |
Allowance for doubtful accounts | Allowance for doubtful accounts We estimate an allowance for doubtful accounts based on our assessment of the collectability of customer accounts. We regularly review the allowance by considering factors such as historical experience, credit quality, the age of the accounts receivable balances, and current economic conditions that may affect a customer’s ability to pay. |
Major customers | Geographic and customer information 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. We sell our products throug h a limited nu mber of d istributors and specialty pharmacies. |
Major suppliers | Major suppliers The use of a relatively small number of contract manufacturers to supply drug necessary for our commercial and clinical operations create a concentration of risk for us. While primarily one source of supply is utilized for certain components of ADCETRIS, PADCEV, TUKYSA and each of our clinical product candidates, other sources are available should we need to change suppliers. For PADCEV, in particular, we rely on Astellas for both commercial and clinical supply as Astellas oversees the manufacturing supply chain. As a form of reducing near-term risk, we also endeavor to maintain reasonable levels of drug supply inventory across the supply chain. A change in suppliers or disruption at one of our suppliers, however, could cause a delay or interruption in delivery of drug or clinical trials. Such an event would adversely affect our business. |
Income taxes | Income taxes 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. Deferred tax assets and liabilities are determined based on the differences between the financial statement and tax bases of assets and liabilities using tax rates in effect for the year in which the differences are expected to reverse. We have provided a valuation allowance against substantially all our deferred tax assets for all periods presented. A valuation allowance is recorded when it is more likely than not that the net deferred tax asset will not be realized. We follow the guidance related to accounting for uncertainty in income taxes, which requires the recognition of an uncertain tax position when it is more likely than not to be sustainable upon audit by the applicable taxing authority. |
Share-based compensation | Share-based compensation We use the graded-vesting attribution method for recognizing compensation expense for our stock options and restricted stock units, or RSUs. Compensation expense is recognized over the requisite service periods on awards ultimately expected to vest and reduced for forfeitures that are estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. For performance-based stock options and RSUs, we record compensation expense over the estimated service period once the achievement of the performance-based milestone is considered probable. At each reporting date, we assess whether achievement of a milestone is considered probable, and if so, record compensation expense based on the portion of the service period elapsed to date with respect to that milestone, with a cumulative catch-up, net of estimated forfeitures. We will recognize remaining compensation expense with respect to a milestone, if any, over the remaining estimated service period. |
Long-term incentive plans | Long-term incentive plans We have established Long-Term Incentive Plans, or LTIPs. The LTIPs provide eligible employees with the opportunity to receive performance-based incentive compensation, which may be comprised of cash, stock options, and/or RSUs. The payment of cash and the grant and/or vesting of equity are contingent upon the achievement of pre-determined regulatory milestones. We record compensation expense over the estimated service period for each milestone subject to the achievement of the milestone being considered probable in accordance with the provisions of ASC Topic 450--Contingencies. At each reporting date, we assess whether achievement of a milestone is considered probable and, if so, record compensation expense based on the portion of the service period elapsed to date with respect to that milestone, with a cumulative catch-up, net of estimated forfeitures. We recognize compensation expense with respect to a milestone over the remaining estimated service period. |
Comprehensive income (loss) | Comprehensive income (loss) Comprehensive income (loss) is the change in stockholders’ equity from transactions and other events and circumstances other than those resulting from investments by stockholders and distributions to stockholders. Our comprehensive income (loss) is comprised of net income (loss), unrealized gains and losses on available-for-sale securities, net of income tax provision and foreign currency translation adjustments, net of income tax provision. |
Loss contingencies | Loss contingencies We are involved in various legal proceedings in the normal course of business. A loss contingency is recorded if it is probable that an asset has been impaired or a liability has been incurred and the amount of the loss can be reasonably estimated. We evaluate, among other factors, the probability of an unfavorable outcome and our ability to make a reasonable estimate and the amount of the ultimate loss. Loss contingencies that are determined to be reasonably possible, but not probable, are disclosed but not recorded. Legal fees incurred as a result of our involvement in legal procedures are expensed as incurred. |
Certain risks and uncertainties | Certain risks and uncertainties Our revenues are derived from net product sales, royalties, and from collaboration and license agreements. Our products are subject to regulation by the FDA in the U.S. and other regulatory agencies outside the U.S. as well as competition by other pharmaceutical companies. Our collaboration and license agreement revenues are derived from a relatively small number of agreements. Each of these agreements can be terminated by our collaborators at their discretion. We are also subject to risks common to companies in the pharmaceutical industry, including risks and uncertainties related to commercial success and acceptance of our products and our potential future products by patients, physicians and payers, competition from other products, regulatory approvals, regulatory requirements, business combinations and product or product candidate acquisition and in-licensing transactions, and protection of intellectual property. Also, drug development is a lengthy process characterized by a relatively low rate of success. We may commit substantial resources toward developing product candidates that never result in further development, achieve regulatory approvals or achieve commercial success. Likewise, we have committed and expect to continue to commit substantial resources towards additional clinical development of our products in an effort to continue to expand our products' labeled indications of use, and there can be no assurance that we and/or our partners will obtain and maintain the necessary regulatory approvals to market our products for any additional indications. |
Guarantees | Guarantees In the normal course of business, we indemnify our directors, certain employees and other parties, including distributors, collaboration partners, lessors and other parties that perform certain work on behalf of, or for us to take licenses to our technologies. We have agreed to hold these parties harmless against losses arising from our breach of representations or covenants, intellectual property infringement or other claims made against these parties in performance of their work with us. These agreements typically limit the time within which the party may seek indemnification by us and the amount of the claim. It is not possible to prospectively determine the maximum potential amount of liability under these indemnification agreements. Further, each potential claim would be based on the unique facts and circumstances of the claim and the particular provisions of each agreement. |
Recent accounting pronouncements adopted | Recent accounting pronouncements adopted In June 2016, Financial Accounting Standards Board, or FASB, issued “ASU 2016-13, Financial Instruments: Credit Losses,” as clarified in ASU 2019-04 and ASU 2019-05. The objective of the standard is to provide information about expected credit losses on financial instruments at each reporting date and to change how other-than-temporary impairments on investment securities are recorded. We adopted this standard on January 1, 2020 using the modified retrospective transition method. The adoption of this ASU had no material impact on our current or previously reported financial condition, results of operations, cash flows, and financial statement disclosures. In August 2018, FASB issued “ASU 2018-15, Customer's Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract.” The objective of the standard is to align the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or obtain internal-use software. We adopted this standard on January 1, 2020 on a prospective basis. The adoption of this ASU did not have a material impact on our financial condition, results of operations, cash flows, and financial statement disclosures. Capitalized implementation costs are included in prepaid expenses and other current assets or other non-current assets. In November 2018, FASB issued “ASU 2018-18, Clarifying the Interaction between Topic 808 and Topic 606.” The objective of the standard is to clarify the interaction between ASC Topic 808--Collaborative Arrangements and ASC Topic 606--Revenue from Contracts with Customers. Currently, ASC Topic 808 does not provide comprehensive recognition or measurement guidance for collaborative arrangements, and the accounting for those arrangements is often based on an analogy to other accounting literature or an accounting policy election. Similarly, aspects of ASC Topic 606 have resulted in uncertainty in practice about the effect of the revenue standard on the accounting for collaborative arrangements. We adopted this standard on January 1, 2020 on a retrospective basis to contracts that were not completed. The adoption of this ASU did not change the way we previously accounted for any of our collaboration arrangements under ASC Topic 808, thus had no impact on our current or previously reported financial condition, results of operations, cash flows, and financial statement disclosures. In December 2019, the FASB issued “ASU 2019-12, Simplifying the Accounting for Income Taxes.” The objective of the standard is to improve areas of GAAP by removing certain exceptions permitted by ASC Topic 740-- Income Taxes and clarifying existing guidance to facilitate consistent application. The standard is effective for us beginning on January 1, 2021. We are currently evaluating the new standard to determine the potential impact on our financial condition, results of operations, cash flows, or financial statement disclosures. |
Organization and Summary of S_3
Organization and Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Schedule of Property and Equipment, Estimated Useful Lives | Property and equipment are stated at cost. Land is not depreciated, while all other property and equipment are depreciated using the straight-line method over the estimated useful lives of the assets, which are generally as follows: Years Building 30 Laboratory and manufacturing equipment 5-15 Furniture and fixtures 5 Computers, software and office equipment 3 Property and equipment consisted of the following: December 31, (dollars in thousands) 2020 2019 Leasehold improvements $ 204,918 $ 154,606 Laboratory and manufacturing equipment 78,724 68,226 Building 23,341 23,341 Computers, software and office equipment 45,141 37,154 Furniture and fixtures 15,825 11,758 Land 4,771 4,771 372,720 299,856 Less: accumulated depreciation and amortization (176,020) (144,365) Total $ 196,700 $ 155,491 |
Schedule of Percent of Revenue Associated with Each Major Distributor or Collaborator | The following table presents each major distributor or collaborator that comprised more than 10% of total revenue: Years ended December 31, 2020 2019 2018 Distributor A 18 % 26 % 28 % Distributor B 15 % 21 % 22 % Distributor C 10 % 18 % 20 % Collaborator B 45 % — % — % Collaborator A 7 % 27 % 21 % |
Schedule of Concentration of Accounts Receivable Attributable to Certain Major Distributors | The following table presents each major distributor or collaborator that accounted for more than 10% of accounts receivable: December 31, 2020 2019 Distributor A 32 % 24 % Distributor B 25 % 19 % Distributor C 16 % 16 % Collaborator A 13 % 33 % |
Schedule of Net Income (Loss) Per Share | The following table shows the calculation of basic and diluted net income (loss) per share: Years ended December 31, (dollars in thousands, except per share amounts) 2020 2019 2018 Net income (loss) $ 613,670 $ (158,650) $ (222,693) Weighted average common shares outstanding - basic 174,834 165,498 157,655 Effect of potentially dilutive common shares 7,453 — — Weighted average common shares outstanding - diluted 182,287 165,498 157,655 Net income (loss) per share - basic $ 3.51 $ (0.96) $ (1.41) Net income (loss) per share - diluted $ 3.37 $ (0.96) $ (1.41) |
Schedule of Weighted-Average Shares Excluded from Number of Shares Used to Calculate Basic and Diluted Net Loss Per Share | The following table presents the weighted average number of shares that have been excluded for all periods presented: Years ended December 31, (in thousands) 2020 2019 2018 Stock options and RSUs 356 12,774 13,439 |
Revenue from contracts with c_2
Revenue from contracts with customers (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Revenue from Contract with Customer [Abstract] | |
Summary of Collaboration and License Agreement Revenues by Collaborator | The following table presents our disaggregated revenue for the years presented: Years ended December 31, (dollars in thousands) 2020 2019 2018 ADCETRIS $ 658,577 $ 627,733 $ 476,903 PADCEV 222,436 244 — TUKYSA 119,585 — — Net product sales $ 1,000,598 $ 627,977 $ 476,903 Royalty revenues $ 126,756 $ 138,491 $ 83,440 Merck $ 975,150 $ — $ — Takeda 32,107 108,175 58,605 Other 40,925 42,070 35,752 Collaboration and license agreement revenues $ 1,048,182 $ 150,245 $ 94,357 Total revenues $ 2,175,536 $ 916,713 $ 654,700 |
Summary of Cumulative Effect and Impacts from Topic 606 | We recorded the following cumulative effect as of January 1, 2018: (dollars in thousands) Collaboration and license agreement revenues $ 10,281 Royalty revenues 22,230 Cost of royalty revenues $ (5,955) Accumulated deficit – (debit) credit $ 26,556 |
Operating leases (Tables)
Operating leases (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Leases [Abstract] | |
Summary of Supplemental Operating Lease Information | Supplemental operating lease information was as follows: Years ended December 31, (dollars in thousands, except term and rate ) 2020 2019 Operating lease cost $ 15,013 $ 13,590 Variable lease cost 3,937 2,958 Total lease cost $ 18,950 $ 16,548 Cash paid for amounts included in measurement of lease liabilities $ 14,265 $ 10,197 Weighted average remaining lease term (in years) 6.16 7.04 Weighted average discount rate 5.2 % 5.4 % |
Summary of Operating Lease Assets and Liabilities | Operating lease liabilities were recorded in the following captions of our consolidated balance sheet as follows: December 31, (dollars in thousands ) 2020 2019 Accrued liabilities and other $ 12,749 $ 9,445 Operating lease liabilities, long-term 61,884 67,607 Total $ 74,633 $ 77,052 |
Schedule of Future Minimum Lease Payments | As of December 31, 2020, future minimum lease payments under the lease agreements were as follows: (dollars in thousands) Years ending December 31, 2021 $ 16,337 2022 15,650 2023 15,030 2024 11,147 2025 7,510 Thereafter 22,656 Total future minimum lease payments 88,330 Less: imputed interest (13,697) Total $ 74,633 |
Acquisition of Cascadian (Table
Acquisition of Cascadian (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Business Combinations [Abstract] | |
Schedule of Purchase Price Allocation of Assets Acquired and Liabilities Assumed | The purchase price allocation of the assets acquired and liabilities assumed based on their estimated fair values as of the acquisition date was as follows: (dollars in thousands) Cash and cash equivalents $ 15,919 Short-term and long-term investments 66,491 Prepaid expenses and other assets 2,215 Property and equipment 566 In-process research and development 300,000 Goodwill 274,671 Accounts payable and accrued liabilities (22,139) Deferred tax liability (23,653) Total purchase price $ 614,070 |
Fair Value (Tables)
Fair Value (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Fair Value Disclosures [Abstract] | |
Fair Value Hierarchy | 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. |
Summary of Fair Value Hierarchy of Assets Carried at Fair Value and Measured on a Recurring Basis | The following table summarized the type of assets measured at fair value on a recurring basis by level within the fair value hierarchy: Fair value measurement using: (dollars in thousands) Quoted prices Other Significant Total December 31, 2020 Short-term investments—U.S. Treasury securities $ 2,000,996 $ — $ — $ 2,000,996 Long-term investments—U.S. Treasury securities 100,830 — — 100,830 Total $ 2,101,826 $ — $ — $ 2,101,826 December 31, 2019 Short-term investments—U.S. Treasury securities $ 536,493 $ — $ — $ 536,493 Long-term investments—U.S. Treasury securities 57,283 — — 57,283 Other non-current assets—equity securities 163,936 — — 163,936 Total $ 757,712 $ — $ — $ 757,712 |
Available-for-Sale Securities | Our debt securities consisted of the following: (dollars in thousands) Amortized Gross Gross Fair December 31, 2020 U.S. Treasury securities $ 2,101,801 $ 259 $ (234) $ 2,101,826 Contractual maturities (at date of purchase): Due in one year or less $ 1,791,399 $ 1,791,239 Due in one to two years 310,402 310,587 Total $ 2,101,801 $ 2,101,826 December 31, 2019 U.S. Treasury securities $ 593,565 $ 236 $ (25) $ 593,776 Contractual maturities (at date of purchase): Due in one year or less $ 466,439 $ 466,547 Due in one to two years 127,126 127,229 Total $ 593,565 $ 593,776 |
Investment and Other Income, _2
Investment and Other Income, Net (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of Investment and Other Income, Net | Investment and other income, net consisted of the following: Years ended December 31, (dollars in thousands) 2020 2019 2018 Gain on equity securities $ 11,604 $ 50,124 $ 7,336 Investment and other income, net 7,245 11,771 6,316 Total investment and other income, net $ 18,849 $ 61,895 $ 13,652 |
Inventories (Tables)
Inventories (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventories | Inventories consisted of the following: December 31, (dollars in thousands) 2020 2019 Raw materials $ 99,049 $ 78,285 Finished goods 17,087 7,647 Total $ 116,136 $ 85,932 |
Property and equipment (Tables)
Property and equipment (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment | Property and equipment are stated at cost. Land is not depreciated, while all other property and equipment are depreciated using the straight-line method over the estimated useful lives of the assets, which are generally as follows: Years Building 30 Laboratory and manufacturing equipment 5-15 Furniture and fixtures 5 Computers, software and office equipment 3 Property and equipment consisted of the following: December 31, (dollars in thousands) 2020 2019 Leasehold improvements $ 204,918 $ 154,606 Laboratory and manufacturing equipment 78,724 68,226 Building 23,341 23,341 Computers, software and office equipment 45,141 37,154 Furniture and fixtures 15,825 11,758 Land 4,771 4,771 372,720 299,856 Less: accumulated depreciation and amortization (176,020) (144,365) Total $ 196,700 $ 155,491 |
Accrued liabilities (Tables)
Accrued liabilities (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued liabilities | Accrued liabilities consisted of the following : December 31, (dollars in thousands) 2020 2019 Employee compensation and benefits $ 96,902 $ 74,835 Clinical trial and related costs 69,756 37,418 Contract manufacturing 20,765 13,866 Gross-to-net deductions and third-party royalties 52,565 37,662 Operating lease liability, current 12,749 9,445 Collaborator contract liability – short-term 30,130 — Professional services and other 27,204 33,839 Total $ 310,071 $ 207,065 |
Income taxes (Tables)
Income taxes (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |
Schedule of Company's Pre-tax Loss by Jurisdiction | Our pre-tax income (loss) by jurisdiction consisted of the following: Years ended December 31, (dollars in thousands) 2020 2019 2018 U.S. $ 613,054 $ (160,189) $ (226,626) Foreign 2,647 1,539 (19,720) Total $ 615,701 $ (158,650) $ (246,346) |
Schedule of Effective Income Tax Rate | A reconciliation of the federal statutory income tax rate to the effective income tax rate is as follows: Years ended December 31, 2020 2019 2018 Statutory federal income tax rate 21.0 % (21.0) % (21.0) % Tax credits (5.4) (11.0) (6.0) Foreign rate differential — — (8.0) State income taxes and other 1.5 (4.7) (3.7) Valuation allowance (8.4) 37.1 44.0 Stock compensation (8.4) (6.4) (3.2) Non-deductible asset basis — 6.0 — Worthless stock deduction — — (12.1) Effective tax rate 0.3 % 0.0 % (10.0) % |
Schedule of Deferred Tax Assets | Our net deferred tax assets consisted of the following: December 31, (dollars in thousands) 2020 2019 Deferred tax assets: Net operating loss carryforwards $ 228,041 $ 331,124 Foreign net operating loss carryforwards 8,341 3,527 Tax credit carryforwards 224,233 193,552 Share-based compensation 33,315 34,869 Allowance and accruals 29,355 26,625 Operating lease liabilities 16,596 18,597 Inventory 19,402 3,815 Capitalized research and development 4,139 4,732 Depreciation — 9,430 Other — 1,133 Total deferred tax assets 563,422 627,404 Less: valuation allowance (489,519) (536,316) Total deferred tax assets, net of valuation allowance 73,903 91,088 Deferred tax liability: Right-of-use assets (13,647) (17,125) Intangibles and amortization (46,018) (50,725) Depreciation (10,215) — Unrealized gain on available-for-sale securities — (20,064) Other (1,970) (3,174) Net deferred tax assets $ 2,053 $ — |
Schedule of Reconciliation of Beginning and Ending Amount of Unrecognized Tax Benefits | A reconciliation of the beginning and ending amount of unrecognized tax benefits is as follows: Years ended December 31, (dollars in thousands) 2020 2019 2018 Balance at January 1 $ 24,018 $ 20,706 $ 18,172 Increase (decrease) related to prior year tax positions (4,008) — 108 Increase related to current year tax positions 3,068 3,312 2,426 Balance at December 31 $ 23,078 $ 24,018 $ 20,706 |
Commitments and contingencies (
Commitments and contingencies (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Noncancelable Obligations | As of December 31, 2020, our future obligations related to supply and other agreements were as follows: (dollars in thousands) Years ending December 31, 2021 $ 141,130 2022 84,384 2023 61,680 2024 44,988 2025 33,816 Thereafter 128 Total $ 366,126 |
Stockholders' equity (Tables)
Stockholders' equity (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Equity [Abstract] | |
Schedule of Common Stock Reserved for Future Issuance | At December 31, 2020, shares of common stock reserved for future issuance are as follows: (in thousands) Stock options and RSUs outstanding 10,917 Shares available for future grant under the 2007 Equity Incentive Plan 8,624 Employee stock purchase plan shares available for future issuance 986 Total 20,527 |
Share-based compensation (Table
Share-based compensation (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Schedule of Stock Options Valuation Assumptions | We calculate the fair value of each option award on the date of grant using the Black-Scholes option pricing model. The following weighted-average assumptions were used for the periods indicated: 2007 Plan Employee Stock Purchase Plan Years ended December 31, Years ended December 31, 2020 2019 2018 2020 2019 2018 Risk-free interest rate 0.3 % 1.5 % 2.8 % 1.3 % 2.2 % 1.7 % Expected lives (in years) 5.7 5.6 5.6 0.5 0.5 0.5 Expected dividend 0 % 0 % 0 % 0 % 0 % 0 % Expected volatility 44 % 44 % 42 % 47 % 43 % 36 % |
Schedule of Stock Option Activity Excluding Performance-Based Stock Options | A summary of stock option activity is as follows : Shares Weighted- Weighted-average Aggregate Balance at December 31, 2019 9,560,510 $ 47.62 Granted 871,939 $ 159.69 Exercised (2,258,503) $ 35.77 Forfeited/expired (292,693) $ 69.50 Balance at December 31, 2020 7,881,253 $ 62.60 6.05 $ 887,226 Expected to vest 7,668,287 $ 61.31 5.98 $ 873,149 Options exercisable 5,236,758 $ 46.10 4.98 $ 675,746 |
Schedule of Non-Vested Restricted Stock Units | A summary of RSU activ ity, excluding performance-based RSUs, is as f ollows: Share Weighted- Non-vested at December 31, 2019 2,991,562 $ 68.66 Granted 816,486 $ 159.51 Vested (1,201,084) $ 60.90 Forfeited (249,458) $ 78.08 Non-vested at December 31, 2020 2,357,506 $ 105.50 |
Long Term Incentive Plan [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Schedule of Non-Vested Restricted Stock Units | A summary of activity related to our performance-based RSUs and LTIPs is as follows: Share Weighted- Non-vested at December 31, 2019 616,643 $ 95.05 Granted 365,070 $ 151.93 Vested (240,667) $ 58.14 Forfeited (62,469) $ 96.89 Non-vested at December 31, 2020 678,577 $ 132.80 |
Quarterly financial data (una_2
Quarterly financial data (unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Quarterly Financial Information Disclosure [Abstract] | |
Schedule of Quarterly Financial Data | The following table contains selected unaudited financial data for each of the indicated periods: Three months ended (dollars in thousands, except per share data) March 31, June 30, September 30, December 31, 2020 Total revenues $ 234,514 $ 277,998 $ 1,061,731 $ 601,293 Net income (loss) $ (168,402) $ (21,190) $ 636,167 $ 167,095 Net income (loss) per share - basic $ (0.98) $ (0.12) $ 3.65 $ 0.93 Net income (loss) per share - diluted $ (0.98) $ (0.12) $ 3.50 $ 0.90 2019 Total revenues $ 195,199 $ 218,447 $ 213,263 $ 289,804 Net income (loss) $ (13,329) $ (79,238) $ (91,913) $ 25,830 Net income (loss) per share - basic $ (0.08) $ (0.49) $ (0.55) $ 0.15 Net income (loss) per share - diluted $ (0.08) $ (0.49) $ (0.55) $ 0.14 |
Net income (loss) per share (Ta
Net income (loss) per share (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Earnings Per Share [Abstract] | |
Schedule of Net Income (Loss) Per Share | The following table shows the calculation of basic and diluted net income (loss) per share: Years ended December 31, (dollars in thousands, except per share amounts) 2020 2019 2018 Net income (loss) $ 613,670 $ (158,650) $ (222,693) Weighted average common shares outstanding - basic 174,834 165,498 157,655 Effect of potentially dilutive common shares 7,453 — — Weighted average common shares outstanding - diluted 182,287 165,498 157,655 Net income (loss) per share - basic $ 3.51 $ (0.96) $ (1.41) Net income (loss) per share - diluted $ 3.37 $ (0.96) $ (1.41) |
Schedule of Weighted-Average Shares Excluded from Number of Shares Used to Calculate Basic and Diluted Net Loss Per Share | The following table presents the weighted average number of shares that have been excluded for all periods presented: Years ended December 31, (in thousands) 2020 2019 2018 Stock options and RSUs 356 12,774 13,439 |
Organization and Summary of S_4
Organization and Summary of Significant Accounting Policies - Additional Information (Details) | 12 Months Ended | |||
Dec. 31, 2020USD ($)Segment | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | |
Summary Of Significant Accounting Policies [Line Items] | ||||
Number of reporting segment operated | Segment | 1 | |||
Accrued capital expenditures | $ 6,000,000 | $ 11,100,000 | ||
Right-of-use assets in exchange for lease liabilities | 7,200,000 | 40,300,000 | ||
Amortization of intangible assets | 16,345,000 | 15,000 | $ 724,000 | |
Intangible asset, carrying value | 305,700,000 | 5,700,000 | ||
Intangible asset, accumulated amortization | 22,000,000 | 5,600,000 | ||
Estimated future amortization expense, 2021 | 23,100,000 | |||
Estimated future amortization expense, 2022 | 23,100,000 | |||
Estimated future amortization expense, 2023 | 23,100,000 | |||
Estimated future amortization expense, 2024 | 23,100,000 | |||
Estimated future amortization expense, 2025 | 23,100,000 | |||
Impairment losses recognized | 0 | |||
Advertising expenses | 59,300,000 | 33,500,000 | 26,600,000 | |
Allowance for doubtful accounts | 0 | 0 | ||
Bad debt expense | 0 | 0 | $ 0 | |
Decrease to retained earnings | $ 869,568,000 | $ 1,483,238,000 | ||
Cumulative Effect, Period of Adoption, Adjustment [Member] | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Decrease to retained earnings | $ 64,100,000 | |||
Weighted Average [Member] | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Intangible asset useful life | 12 years |
Organization and Summary of S_5
Organization and Summary of Significant Accounting Policies - Schedule of Property and Equipment, Estimated Useful Lives (Details) | 12 Months Ended |
Dec. 31, 2020 | |
Building [Member] | |
Property, Plant and Equipment [Line Items] | |
Useful life | 30 years |
Equipment [Member] | Minimum [Member] | |
Property, Plant and Equipment [Line Items] | |
Useful life | 5 years |
Equipment [Member] | Maximum [Member] | |
Property, Plant and Equipment [Line Items] | |
Useful life | 15 years |
Furniture and Fixtures [Member] | |
Property, Plant and Equipment [Line Items] | |
Useful life | 5 years |
Computers, Software and Office Equipment [Member] | |
Property, Plant and Equipment [Line Items] | |
Useful life | 3 years |
Organization and Summary of S_6
Organization and Summary of Significant Accounting Policies - Schedule of Percent of Revenue Associated with Each Major Distributor or Collaborator (Details) - Customer Concentration Risk [Member] - Sales Revenue [Member] | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Distributor A [Member] | |||
Concentration Risk [Line Items] | |||
Percent of total revenues | 18.00% | 26.00% | 28.00% |
Distributor B [Member] | |||
Concentration Risk [Line Items] | |||
Percent of total revenues | 15.00% | 21.00% | 22.00% |
Distributor C [Member] | |||
Concentration Risk [Line Items] | |||
Percent of total revenues | 10.00% | 18.00% | 20.00% |
Merck [Member] | |||
Concentration Risk [Line Items] | |||
Percent of total revenues | 45.00% | 0.00% | 0.00% |
Takeda [Member] | |||
Concentration Risk [Line Items] | |||
Percent of total revenues | 7.00% | 27.00% | 21.00% |
Organization and Summary of S_7
Organization and Summary of Significant Accounting Policies - Schedule of Concentration of Accounts Receivable Attributable to Certain Major Distributors (Details) - Credit Concentration Risk [Member] - Accounts Receivable, Net [Member] | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Distributor A [Member] | ||
Concentration Risk [Line Items] | ||
Percent of total accounts receivable | 32.00% | 24.00% |
Distributor B [Member] | ||
Concentration Risk [Line Items] | ||
Percent of total accounts receivable | 25.00% | 19.00% |
Distributor C [Member] | ||
Concentration Risk [Line Items] | ||
Percent of total accounts receivable | 16.00% | 16.00% |
Takeda [Member] | ||
Concentration Risk [Line Items] | ||
Percent of total accounts receivable | 13.00% | 33.00% |
Organization and Summary of S_8
Organization and Summary of Significant Accounting Policies - Schedule of Net Income (Loss) Per Share (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2020 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Earnings Per Share [Abstract] | |||||||||||
Net income (loss) | $ 167,095 | $ 636,167 | $ (21,190) | $ (168,402) | $ 25,830 | $ (91,913) | $ (79,238) | $ (13,329) | $ 613,670 | $ (158,650) | $ (222,693) |
Shares used in computation of per share amounts - basic (in shares) | 174,834 | 165,498 | 157,655 | ||||||||
Dilutive potential common shares (in shares) | 7,453 | 0 | 0 | ||||||||
Shares used in computation of per share amounts - diluted (in shares) | 182,287 | 165,498 | 157,655 | ||||||||
Net income (loss) per share - basic (in dollars per share) | $ 0.93 | $ 3.65 | $ (0.12) | $ (0.98) | $ 0.15 | $ (0.55) | $ (0.49) | $ (0.08) | $ 3.51 | $ (0.96) | $ (1.41) |
Net income (loss) per share - diluted (in dollars per share) | $ 0.90 | $ 3.50 | $ (0.12) | $ (0.98) | $ 0.14 | $ (0.55) | $ (0.49) | $ (0.08) | $ 3.37 | $ (0.96) | $ (1.41) |
Organization and Summary of S_9
Organization and Summary of Significant Accounting Policies - Schedule of Weighted-Average Shares Excluded from Number of Shares Used to Calculate Basic and Diluted Net Loss Per Share (Details) - shares shares in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Stock Options and RSUs [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Weighted-average shares that have been excluded from the number of shares used to calculate basic and diluted net loss per share (in shares) | 356 | 12,774 | 13,439 |
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 | 12 Months Ended | |||||||||
Dec. 31, 2020 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Disaggregation of Revenue [Line Items] | |||||||||||
Total revenues | $ 601,293 | $ 1,061,731 | $ 277,998 | $ 234,514 | $ 289,804 | $ 213,263 | $ 218,447 | $ 195,199 | $ 2,175,536 | $ 916,713 | $ 654,700 |
Product [Member] | |||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||
Total revenues | 1,000,598 | 627,977 | 476,903 | ||||||||
Product [Member] | ADCETRIS [Member] | |||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||
Total revenues | 658,577 | 627,733 | 476,903 | ||||||||
Product [Member] | PADCEV [Member] | |||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||
Total revenues | 222,436 | 244 | 0 | ||||||||
Product [Member] | TUKYSA [Member] | |||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||
Total revenues | 119,585 | 0 | 0 | ||||||||
Royalty [Member] | |||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||
Total revenues | 126,756 | 138,491 | 83,440 | ||||||||
Collaboration and License Agreement [Member] | |||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||
Total revenues | 1,048,182 | 150,245 | 94,357 | ||||||||
Collaboration and License Agreement [Member] | Merck Collaboration and License Agreement [Member] | |||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||
Total revenues | 975,150 | 0 | 0 | ||||||||
Collaboration and License Agreement [Member] | Takeda Collaboration and License Agreement [Member] | |||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||
Total revenues | 32,107 | 108,175 | 58,605 | ||||||||
Collaboration and License Agreement [Member] | Other Collaboration and License Agreement [Member] | |||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||
Total revenues | $ 40,925 | $ 42,070 | $ 35,752 |
Revenue from contracts with c_4
Revenue from contracts with customers - Additional Information (Details) - USD ($) | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2020 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Revenue from Contracts with Customers [Line Items] | |||||||||||
Total revenues | $ 601,293,000 | $ 1,061,731,000 | $ 277,998,000 | $ 234,514,000 | $ 289,804,000 | $ 213,263,000 | $ 218,447,000 | $ 195,199,000 | $ 2,175,536,000 | $ 916,713,000 | $ 654,700,000 |
Contract asset | 0 | 0 | 0 | 0 | |||||||
Contract liability | $ 0 | $ 0 | 0 | 0 | |||||||
Collaboration and License Agreement [Member] | |||||||||||
Revenue from Contracts with Customers [Line Items] | |||||||||||
Deferred revenue recognized | 0 | 33,600,000 | 34,500,000 | ||||||||
Collaboration and License Agreement [Member] | |||||||||||
Revenue from Contracts with Customers [Line Items] | |||||||||||
Total revenues | $ 1,048,182,000 | 150,245,000 | $ 94,357,000 | ||||||||
BeiGene [Member] | Collaboration and License Agreement [Member] | |||||||||||
Revenue from Contracts with Customers [Line Items] | |||||||||||
Total revenues | $ 20,000,000 |
Revenue from contracts with c_5
Revenue from contracts with customers - Summary of Impact of Topic 606 (Details) - USD ($) $ in Thousands | Jan. 01, 2018 | Dec. 31, 2020 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||||||||||
Total revenues | $ 601,293 | $ 1,061,731 | $ 277,998 | $ 234,514 | $ 289,804 | $ 213,263 | $ 218,447 | $ 195,199 | $ 2,175,536 | $ 916,713 | $ 654,700 | |
Accumulated deficit | $ (869,568) | $ (1,483,238) | (869,568) | (1,483,238) | ||||||||
Accounting Standards Update 2014-09 [Member] | Difference between Revenue Guidance in Effect before and after Topic 606 [Member] | ||||||||||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||||||||||
Cost of royalty revenues | $ (5,955) | |||||||||||
Accumulated deficit | 26,556 | |||||||||||
Collaboration and License Agreement [Member] | ||||||||||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||||||||||
Total revenues | 1,048,182 | 150,245 | 94,357 | |||||||||
Collaboration and License Agreement [Member] | Accounting Standards Update 2014-09 [Member] | Difference between Revenue Guidance in Effect before and after Topic 606 [Member] | ||||||||||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||||||||||
Total revenues | 10,281 | |||||||||||
Royalty [Member] | ||||||||||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||||||||||
Total revenues | $ 126,756 | $ 138,491 | $ 83,440 | |||||||||
Royalty [Member] | Accounting Standards Update 2014-09 [Member] | Difference between Revenue Guidance in Effect before and after Topic 606 [Member] | ||||||||||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||||||||||
Total revenues | $ 22,230 |
Operating leases - Additional I
Operating leases - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Jan. 01, 2019 | |
Leases [Abstract] | ||||
Operating lease liability | $ 74,633 | $ 77,052 | $ 35,200 | |
Operating lease right-of-use assets | 61,480 | 65,230 | $ 34,700 | |
Right-of-use assets in exchange for lease liabilities | 7,200 | 40,300 | ||
Rent expense | $ 16,600 | $ 14,600 | ||
Rent expense | $ 8,700 |
Operating leases - Supplemental
Operating leases - Supplemental Information (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Leases [Abstract] | ||
Operating lease cost | $ 15,013 | $ 13,590 |
Variable lease cost | 3,937 | 2,958 |
Total lease cost | 18,950 | 16,548 |
Cash paid for amounts included in measurement of lease liabilities | $ 14,265 | $ 10,197 |
Weighted average remaining lease term (in years) | 6 years 1 month 28 days | 7 years 14 days |
Weighted average discount rate | 5.20% | 5.40% |
Operating leases - Future Minim
Operating leases - Future Minimum Payments (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 | Jan. 01, 2019 |
Leases [Abstract] | |||
2021 | $ 16,337 | ||
2022 | 15,650 | ||
2023 | 15,030 | ||
2024 | 11,147 | ||
2025 | 7,510 | ||
Thereafter | 22,656 | ||
Total future minimum lease payments | 88,330 | ||
Less: imputed interest | (13,697) | ||
Total | $ 74,633 | $ 77,052 | $ 35,200 |
Operating leases - Balance Shee
Operating leases - Balance Sheet Information (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 | Jan. 01, 2019 |
Leases [Abstract] | |||
Operating lease liability, current | $ 12,749 | $ 9,445 | |
Operating lease liabilities, long-term | 61,884 | 67,607 | |
Total | $ 74,633 | $ 77,052 | $ 35,200 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | sgen:AccruedLiabilitiesAndOtherLiabilitiesCurrent | sgen:AccruedLiabilitiesAndOtherLiabilitiesCurrent |
Acquisition of Cascadian - Addi
Acquisition of Cascadian - Additional Information (Details) - Cascadian Therapeutics [Member] $ / shares in Units, $ in Millions | 12 Months Ended |
Dec. 31, 2018USD ($)$ / shares | |
Business Acquisition [Line Items] | |
Share price (in dollars per share) | $ / shares | $ 10 |
Payments to acquire business | $ 614.1 |
Acquisition-related costs | $ 8.5 |
Acquisition of Cascadian - Sche
Acquisition of Cascadian - Schedule of Purchase Price Allocation of Assets Acquired and Liabilities Assumed (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Business Acquisition [Line Items] | |||
Goodwill | $ 274,671 | $ 274,671 | |
Cascadian Therapeutics [Member] | |||
Business Acquisition [Line Items] | |||
Cash and cash equivalents | $ 15,919 | ||
Short-term and long-term investments | 66,491 | ||
Prepaid expenses and other assets | 2,215 | ||
Property and equipment | 566 | ||
In-process research and development | 300,000 | ||
Goodwill | 274,671 | ||
Accounts payable and accrued liabilities | (22,139) | ||
Deferred tax liability | (23,653) | ||
Total purchase price | $ 614,070 |
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 [Member] - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | $ 2,101,826 | $ 757,712 |
Short-term Investments [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 2,000,996 | 536,493 |
Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 2,101,826 | 757,712 |
Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | Short-term Investments [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 2,000,996 | 536,493 |
Other Observable Inputs (Level 2) [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 0 | 0 |
Other Observable Inputs (Level 2) [Member] | Short-term Investments [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 0 | 0 |
Significant Unobservable Inputs (Level 3) [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 0 | 0 |
Significant Unobservable Inputs (Level 3) [Member] | Short-term Investments [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 0 | 0 |
US Treasury Securities [Member] | US Treasury Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 100,830 | 57,283 |
US Treasury Securities [Member] | Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | US Treasury Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 100,830 | 57,283 |
US Treasury Securities [Member] | Other Observable Inputs (Level 2) [Member] | US Treasury Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 0 | 0 |
US Treasury Securities [Member] | Significant Unobservable Inputs (Level 3) [Member] | US Treasury Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | $ 0 | 0 |
Common Stock Investment in Immunomedics (Equity Securities) [Member] | Other Non-current Assets [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 163,936 | |
Common Stock Investment in Immunomedics (Equity Securities) [Member] | Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | Other Non-current Assets [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 163,936 | |
Common Stock Investment in Immunomedics (Equity Securities) [Member] | Other Observable Inputs (Level 2) [Member] | Other Non-current Assets [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 0 | |
Common Stock Investment in Immunomedics (Equity Securities) [Member] | Significant Unobservable Inputs (Level 3) [Member] | Other Non-current Assets [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | $ 0 |
Fair Value - Additional Informa
Fair Value - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Fair Value Disclosures [Abstract] | ||
Credit loss | $ 0 | $ 0 |
Allowance for credit loss | $ 0 |
Fair Value - Summary of Debt Se
Fair Value - Summary of Debt Securities (Details) - US Treasury Securities [Member] - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Debt Securities, Available-for-sale [Line Items] | ||
Available-for-sale securities, Amortized cost | $ 2,101,801 | $ 593,565 |
Available-for-sale securities, Gross unrealized gains | 259 | 236 |
Available-for-sale securities, Gross unrealized losses | (234) | (25) |
Available-for-sale securities, Fair value | 2,101,826 | 593,776 |
Debt securities, due in one year or less, amortized cost | 1,791,399 | 466,439 |
Debt securities, due in one year or less, fair value | 1,791,239 | 466,547 |
Debt securities, due in one to two years, amortized cost | 310,402 | 127,126 |
Debt securities, due in one to two years, fair value | $ 310,587 | $ 127,229 |
Investment and Other Income, _3
Investment and Other Income, Net - Schedule of Investment and Other Income (Loss) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Investments, Debt and Equity Securities [Abstract] | |||
Gain on equity securities | $ 11,604 | $ 50,124 | $ 7,336 |
Investment and other income, net | 7,245 | 11,771 | 6,316 |
Total investment and other income, net | $ 18,849 | $ 61,895 | $ 13,652 |
Investment and Other Income, _4
Investment and Other Income, Net - Additional Information (Details) $ in Millions | 1 Months Ended |
Apr. 30, 2020USD ($) | |
Investments, Debt and Equity Securities [Abstract] | |
Proceeds from sale of investment | $ 174.7 |
Inventories - Schedule of Inven
Inventories - Schedule of Inventories (Detail) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 99,049 | $ 78,285 |
Finished goods | 17,087 | 7,647 |
Total | $ 116,136 | $ 85,932 |
Property and equipment - Schedu
Property and equipment - Schedule of Property and Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 372,720 | $ 299,856 |
Less: accumulated depreciation and amortization | (176,020) | (144,365) |
Total | 196,700 | 155,491 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 204,918 | 154,606 |
Laboratory And Manufacturing Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 78,724 | 68,226 |
Building [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 23,341 | 23,341 |
Computers, Software and Office Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 45,141 | 37,154 |
Furniture and Fixtures [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 15,825 | 11,758 |
Land [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 4,771 | $ 4,771 |
Property and equipment - Additi
Property and equipment - Additional Information (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Property, Plant and Equipment [Abstract] | |||
Depreciation and amortization expenses | $ 36 | $ 23.8 | $ 25.3 |
Construction in process included in Leasehold improvements | $ 24.5 | $ 62.2 |
Accrued liabilities (Details)
Accrued liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Payables and Accruals [Abstract] | ||
Employee compensation and benefits | $ 96,902 | $ 74,835 |
Clinical trial and related costs | 69,756 | 37,418 |
Contract manufacturing | 20,765 | 13,866 |
Gross-to-net deductions and third-party royalties | 52,565 | 37,662 |
Operating lease liability, current | 12,749 | 9,445 |
Collaborator contract liability – short-term | 30,130 | 0 |
Professional services and other | 27,204 | 33,839 |
Total | $ 310,071 | $ 207,065 |
Income taxes - Schedule of Comp
Income taxes - Schedule of Company's Pre-tax Loss by Jurisdiction (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Income (Loss) from Continuing Operations before Equity Method Investments, Income Taxes, Noncontrolling Interest [Abstract] | |||
U.S. | $ 613,054 | $ (160,189) | $ (226,626) |
Foreign | 2,647 | 1,539 | (19,720) |
Total | $ 615,701 | $ (158,650) | $ (246,346) |
Income Taxes - Schedule of Effe
Income Taxes - Schedule of Effective Income Tax Rate (Details) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Effective Income Tax Rate Reconciliation, Other Reconciling Items, Percent [Abstract] | |||
Statutory federal income tax rate | 21.00% | 21.00% | 21.00% |
Tax credits | (5.40%) | 11.00% | 6.00% |
Foreign rate differential | 0.00% | 0.00% | 8.00% |
State income taxes and other | 1.50% | 4.70% | 3.70% |
Valuation allowance | (8.40%) | (37.10%) | (44.00%) |
Stock compensation | (8.40%) | 6.40% | 3.20% |
Non-deductible asset basis | 0.00% | (6.00%) | 0.00% |
Worthless stock deduction | 0.00% | 0.00% | 12.10% |
Effective tax rate | 0.30% | (0.00%) | 10.00% |
Income taxes - Additional Infor
Income taxes - Additional Information (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Income Taxes [Line Items] | |||
Income tax expense (benefit) | $ (2,031,000) | $ 0 | $ 23,653,000 |
Current state tax | 3,700,000 | ||
Foreign tax benefit | 1,700,000 | ||
Increase (decrease) in the valuation allowance | (46,800,000) | $ 58,500,000 | 113,300,000 |
Increase in net deferred tax asset | 143,300,000 | ||
State [Member] | |||
Income Taxes [Line Items] | |||
State tax liabilities | 3,700,000 | ||
Gross net operating loss carryforwards | 367,700,000 | ||
Federal [Member] | |||
Income Taxes [Line Items] | |||
Gross net operating loss carryforwards | 971,000,000 | ||
Indefinite operating loss carryforwards | 391,200,000 | ||
Operating loss carryforwards, subject to expiration | 579,800,000 | ||
Foreign [Member] | |||
Income Taxes [Line Items] | |||
Gross net operating loss carryforwards | 42,300,000 | ||
Tax credit carryforward | 247,300,000 | ||
Cascadian Therapeutics [Member] | |||
Income Taxes [Line Items] | |||
Deferred tax liability | 23,653,000 | ||
Foreign Operating Loss Carryforward [Member] | |||
Income Taxes [Line Items] | |||
Increase (decrease) in the valuation allowance | $ (2,100,000) | ||
Accounting Standards Update 2014-09 [Member] | |||
Income Taxes [Line Items] | |||
Increase (decrease) in the valuation allowance | $ (6,300,000) |
Income Taxes - Schedule of Defe
Income Taxes - Schedule of Deferred Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 228,041 | $ 331,124 |
Foreign net operating loss carryforwards | 8,341 | 3,527 |
Tax credit carryforwards | 224,233 | 193,552 |
Share-based compensation | 33,315 | 34,869 |
Allowance and accruals | 29,355 | 26,625 |
Operating lease liabilities | 16,596 | 18,597 |
Inventory | 19,402 | 3,815 |
Capitalized research and development | 4,139 | 4,732 |
Depreciation | 0 | 9,430 |
Other | 0 | 1,133 |
Total deferred tax assets | 563,422 | 627,404 |
Less: valuation allowance | (489,519) | (536,316) |
Total deferred tax assets, net of valuation allowance | 73,903 | 91,088 |
Deferred tax liability: | ||
Right-of-use assets | (13,647) | (17,125) |
Intangibles and amortization | (46,018) | (50,725) |
Depreciation | (10,215) | 0 |
Unrealized gain on available-for-sale securities | 0 | (20,064) |
Other | (1,970) | (3,174) |
Net deferred tax assets | $ 2,053 | $ 0 |
Income Taxes - Schedule of Reco
Income Taxes - Schedule of Reconciliation of Beginning and Ending Amount of Unrecognized Tax Benefits (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Reconciliation of the Beginning and Ending Amount of Unrecognized Tax Benefits | |||
Balance at January 1 | $ 24,018 | $ 20,706 | $ 18,172 |
Increase (decrease) related to prior year tax positions | 0 | 108 | |
Increase (decrease) related to prior year tax positions | (4,008) | ||
Increase related to current year tax positions | 3,068 | 3,312 | 2,426 |
Balance at December 31 | $ 23,078 | $ 24,018 | $ 20,706 |
Collaboration and license agr_2
Collaboration and license agreements (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||||||||
Oct. 31, 2020USD ($)$ / sharesshares | Sep. 30, 2020USD ($)agreement | Dec. 31, 2020USD ($) | Sep. 30, 2020USD ($) | Jun. 30, 2020USD ($) | Mar. 31, 2020USD ($) | Dec. 31, 2019USD ($) | Sep. 30, 2019USD ($) | Jun. 30, 2019USD ($) | Mar. 31, 2019USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Cost of sales | $ 217,720 | $ 43,952 | $ 88,293 | ||||||||||
Number of agreements entered into | agreement | 2 | ||||||||||||
Shares issued (in shares) | shares | 5,000,000 | ||||||||||||
Price per share (in dollars per share) | $ / shares | $ 200 | ||||||||||||
Proceeds from sale of stock | $ 1,000,000 | ||||||||||||
Fair value of shares issued | 749,900 | 749,850 | 548,691 | 658,242 | |||||||||
Total revenues | $ 601,293 | $ 1,061,731 | $ 277,998 | $ 234,514 | $ 289,804 | $ 213,263 | $ 218,447 | $ 195,199 | 2,175,536 | 916,713 | 654,700 | ||
Collaboration and License Agreement [Member] | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Total revenues | 1,048,182 | 150,245 | 94,357 | ||||||||||
Astellas Collaboration and License Agreements [Member] | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Third party research and development expenses incurred | 99,300 | 76,800 | 54,900 | ||||||||||
PADCEV [Member] | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Cost of sales | 104,600 | ||||||||||||
Genmab Collaboration and License Agreements [Member] | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Third party research and development expenses incurred | $ 50,100 | $ 48,500 | $ 33,800 | ||||||||||
Percentage of sales representatives and medical science liaisons maintained by company | 50.00% | ||||||||||||
Percentage of costs entity is responsible for | 50.00% | ||||||||||||
TUKYSA Agreement [Member] | Collaboration and License Agreement [Member] | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Upfront cash payment received | $ 125,000 | ||||||||||||
Milestone payment (up to) | $ 65,000 | ||||||||||||
Prepaid research and development expense | $ 85,000 | ||||||||||||
Remaining co-development liability | $ 80,900 | $ 80,900 | |||||||||||
L V Agreement [Member] | Collaboration and License Agreement [Member] | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Percentage of costs entity is responsible for | 50.00% | ||||||||||||
Upfront cash payment received | $ 600,000 | ||||||||||||
Milestone payment (up to) | 850,000 | ||||||||||||
Milestone payment upon achievement of annual sales threshold (up to) | $ 1,750,000 | ||||||||||||
Percentage of profits to be received | 50.00% | ||||||||||||
Purchase Agreement [Member] | Collaboration and License Agreement [Member] | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Total revenues | $ 250,100 |
In-license agreements (Details)
In-license agreements (Details) | 12 Months Ended |
Dec. 31, 2020agreement | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Number of licensing agreements | 2 |
Commitments and Contingencies_2
Commitments and Contingencies (Details) $ in Thousands | Dec. 31, 2020USD ($) |
Contractual Obligation, Fiscal Year Maturity [Abstract] | |
2021 | $ 141,130 |
2022 | 84,384 |
2023 | 61,680 |
2024 | 44,988 |
2025 | 33,816 |
Thereafter | 128 |
Total | $ 366,126 |
Legal matters (Details)
Legal matters (Details) | 1 Months Ended |
Jan. 22, 2021petition | |
Subsequent Event [Member] | |
Subsequent Event [Line Items] | |
Number of petitions filed | 2 |
Stockholders' equity - Addition
Stockholders' equity - Additional information (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||||||||||
Oct. 31, 2020 | Jul. 31, 2019 | Feb. 28, 2018 | Dec. 31, 2020 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||
Shares issued (in shares) | 5,000,000 | |||||||||||||
Price per share (in dollars per share) | $ 200 | |||||||||||||
Proceeds from sale of stock | $ 1,000,000 | |||||||||||||
Fair value of shares issued | 749,900 | $ 749,850 | $ 548,691 | $ 658,242 | ||||||||||
Total revenues | $ 601,293 | $ 1,061,731 | $ 277,998 | $ 234,514 | $ 289,804 | $ 213,263 | $ 218,447 | $ 195,199 | 2,175,536 | 916,713 | 654,700 | |||
Collaboration and License Agreement [Member] | ||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||
Total revenues | $ 1,048,182 | $ 150,245 | $ 94,357 | |||||||||||
Collaboration and License Agreement [Member] | Purchase Agreement [Member] | ||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||
Total revenues | $ 250,100 | |||||||||||||
Underwritten Public Offering [Member] | ||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||
Shares issued (in shares) | 8,214,286 | 13,269,230 | ||||||||||||
Price per share (in dollars per share) | $ 70 | $ 52 | ||||||||||||
Proceeds from sale of stock | $ 548,700 | $ 658,200 |
Stockholders' equity - Schedule
Stockholders' equity - Schedule of Common Stock Reserved for Future Issuance (Details) shares in Thousands | Dec. 31, 2020shares |
Equity [Abstract] | |
Stock options and RSUs outstanding (in shares) | 10,917 |
Shares available for future grant under the 2007 Equity Incentive Plan (in shares) | 8,624 |
Employee stock purchase plan shares available for future issuance (in shares) | 986 |
Total common stock reserved for future issuance (in shares) | 20,527 |
Share-based compensation - 2007
Share-based compensation - 2007 Equity Incentive Plan - Additional Information (Details) | 12 Months Ended |
Dec. 31, 2020shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Additional shares reserved for issuance by plan amendment (in shares) | 6,000,000 |
2007 Equity Incentive Plan [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Common stock reserved for issuance (in shares) | 39,000,000 |
Minimum percentage of exercise price stock at grant date fair market value | 100.00% |
Maximum term from date of grant, years | 10 years |
Share-based Payment Arrangement, Employee [Member] | 2007 Equity Incentive Plan [Member] | Share-based Payment Arrangement, Option [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Initial vesting period, percentage | 25.00% |
Initial vesting period, years | 1 year |
Subsequent vesting period, years | 36 months |
Share-based Payment Arrangement, Employee [Member] | 2007 Equity Incentive Plan [Member] | Restricted Stock Units (RSUs) [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Initial vesting period, percentage | 25.00% |
Share-based Payment Arrangement, Nonemployee [Member] | 2007 Equity Incentive Plan [Member] | Restricted Stock Units (RSUs) [Member] | Board Of Directors [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Vesting period | 1 year |
Share-based compensation - Shar
Share-based compensation - Share-based compensation expense - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share based compensation cost | $ 147,233 | $ 127,349 | $ 78,861 |
Share-based compensation tax benefit | 55,700 | ||
Research and Development Expense [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share based compensation cost | 72,700 | 64,700 | 40,400 |
Selling, General and Administrative Expenses [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share based compensation cost | $ 74,500 | $ 62,600 | $ 38,500 |
Share-based compensation - Sche
Share-based compensation - Schedule of Stock Options Valuation Assumptions (Details) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
2007 Equity Incentive Plan [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Risk-free interest rate | 0.30% | 1.50% | 2.80% |
Expected lives (in years) | 5 years 8 months 12 days | 5 years 7 months 6 days | 5 years 7 months 6 days |
Expected dividend | 0.00% | 0.00% | 0.00% |
Expected volatility | 44.00% | 44.00% | 42.00% |
Employee Stock Purchase Plan [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Risk-free interest rate | 1.30% | 2.20% | 1.70% |
Expected lives (in years) | 6 months | 6 months | 6 months |
Expected dividend | 0.00% | 0.00% | 0.00% |
Expected volatility | 47.00% | 43.00% | 36.00% |
Share-based compensation - Sc_2
Share-based compensation - Schedule of Stock Option Activity (Details) - 2007 Equity Incentive Plan [Member] - Option Plan [Member] $ / shares in Units, $ in Thousands | 12 Months Ended |
Dec. 31, 2020USD ($)$ / sharesshares | |
Shares | |
Beginning balance, shares (in shares) | shares | 9,560,510 |
Granted, shares (in shares) | shares | 871,939 |
Exercised, shares (in shares) | shares | (2,258,503) |
Forfeited/expired, shares (in shares) | shares | (292,693) |
Ending balance, shares (in shares) | shares | 7,881,253 |
Expected to vest, shares (in shares) | shares | 7,668,287 |
Options exercisable, shares (in shares) | shares | 5,236,758 |
Weighted- average exercise price per share | |
Beginning balance, weighted-average exercise price per share (in dollars per share) | $ / shares | $ 47.62 |
Granted, weighted-average exercise price per share (in dollars per share) | $ / shares | 159.69 |
Exercised, weighted-average exercise price per share (in dollars per share) | $ / shares | 35.77 |
Forfeited/expired, weighted-average exercise price per share (in dollars per share) | $ / shares | 69.50 |
Ending balance, weighted-average exercise price per share (in dollars per share) | $ / shares | 62.60 |
Expected to vest, weighted-average exercise price per share (in dollars per share) | $ / shares | 61.31 |
Options exercisable, weighted-average exercise price per share (in dollars per share) | $ / shares | $ 46.10 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Additional Disclosures [Abstract] | |
Outstanding, weighted-average remaining contractual term (in years), Options outstanding | 6 years 18 days |
Expected to vest, weighted-average remaining contractual term (in years), Expected to vest | 5 years 11 months 23 days |
Options exercisable, weighted-average remaining contractual term (in years), Options exercisable | 4 years 11 months 23 days |
Options outstanding, aggregate intrinsic value | $ | $ 887,226 |
Expected to vest, aggregate intrinsic value | $ | 873,149 |
Options exercisable, aggregate intrinsic value | $ | $ 675,746 |
Share-based compensation - Stoc
Share-based compensation - Stock Option Activity - Additional Information (Details) - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Unrecognized compensation cost related to unvested share-based compensation | $ 74 | ||
2007 Equity Incentive Plan [Member] | Option Plan [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Weighted average grant-date fair values of options granted (in dollars per share) | $ 64.66 | $ 30.51 | $ 30.77 |
Aggregate intrinsic value of options exercised | $ 271 | $ 128.4 | $ 73.3 |
Unrecognized compensation cost related to unvested share-based compensation | $ 52.4 | ||
Unrecognized compensation of weighted-average period, years | 1 year 2 months 19 days |
Share-based compensation - Sc_3
Share-based compensation - Schedule of Non-Vested Restricted Stock Units (Details) - 2007 Equity Incentive Plan [Member] - Restricted Stock Units (RSUs) [Member] - $ / shares | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Share equivalent | |||
Non-vested beginning balance, share equivalent (in shares) | 2,991,562 | ||
Granted, share equivalent (in shares) | 816,486 | ||
Vested, share equivalent (in shares) | (1,201,084) | ||
Forfeited, share equivalent (in shares) | (249,458) | ||
Non-vested, ending balance, share equivalent (in shares) | 2,357,506 | 2,991,562 | |
Weighted- average grant date fair value | |||
Non-vested, weighted-average grant date fair value (in dollars per share) | $ 68.66 | ||
Granted, weighted-average grant date fair value (in dollars per share) | 159.51 | $ 75.58 | $ 70.78 |
Vested, weighted-average grant date fair value (in dollars per share) | 60.90 | ||
Forfeited, weighted-average grant date fair value (in dollars per share) | 78.08 | ||
Non-vested, weighted-average grant date fair value (in dollars per share) | $ 105.50 | $ 68.66 |
Share-based compensation - RSU
Share-based compensation - RSU Activity - Additional Information (Details) - 2007 Equity Incentive Plan [Member] - Restricted Stock Units (RSUs) [Member] - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Granted, weighted-average grant date fair value (in dollars per share) | $ 159.51 | $ 75.58 | $ 70.78 |
Value of stock awards vested during the period | $ 187.1 | $ 67.1 | $ 42.4 |
Unrecognized compensation cost related to unvested share-based compensation | $ 144.7 | ||
Unrecognized compensation of weighted-average period, years | 1 year 7 months 6 days |
Share-based compensation - Sc_4
Share-based compensation - Schedule of LTIP equity activity (Details) - Restricted Stock Units (RSUs) [Member] - Long Term Incentive Plan [Member] | 12 Months Ended |
Dec. 31, 2020$ / sharesshares | |
Share equivalent | |
Non-vested beginning balance, share equivalent (in shares) | shares | 616,643 |
Granted, share equivalent (in shares) | shares | 365,070 |
Vested, share equivalent (in shares) | shares | (240,667) |
Forfeited, share equivalent (in shares) | shares | (62,469) |
Non-vested, ending balance, share equivalent (in shares) | shares | 678,577 |
Weighted- average grant date fair value | |
Non-vested, weighted-average grant date fair value (in dollars per share) | $ / shares | $ 95.05 |
Granted, weighted-average grant date fair value (in dollars per share) | $ / shares | 151.93 |
Vested, weighted-average grant date fair value (in dollars per share) | $ / shares | 58.14 |
Forfeited, weighted-average grant date fair value (in dollars per share) | $ / shares | 96.89 |
Non-vested, weighted-average grant date fair value (in dollars per share) | $ / shares | $ 132.80 |
Share-based compensation - LTIP
Share-based compensation - LTIP Activity - Additional Information (Details) $ in Millions | Dec. 31, 2020USD ($) |
Share-based Payment Arrangement [Abstract] | |
Unrecognized compensation cost related to unvested share-based compensation | $ 74 |
Share-based compensation - Empl
Share-based compensation - Employee Stock Purchase Plan - Additional Information (Details) - shares | 1 Months Ended | 12 Months Ended |
May 31, 2019 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Additional shares reserved for issuance (in shares) | 6,000,000 | |
Employee Stock Purchase Plan [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Discounted stock purchase price, percent of market value | 85.00% | |
Additional shares reserved for issuance (in shares) | 1,000,000 |
Employee benefit plan (Details)
Employee benefit plan (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Retirement Benefits [Abstract] | |||
Total contribution made by employer under matching program | $ 18 | $ 11.9 | $ 7.7 |
Quarterly financial data (una_3
Quarterly financial data (unaudited) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2020 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Quarterly Financial Information Disclosure [Abstract] | |||||||||||
Total revenues | $ 601,293 | $ 1,061,731 | $ 277,998 | $ 234,514 | $ 289,804 | $ 213,263 | $ 218,447 | $ 195,199 | $ 2,175,536 | $ 916,713 | $ 654,700 |
Net income (loss) | $ 167,095 | $ 636,167 | $ (21,190) | $ (168,402) | $ 25,830 | $ (91,913) | $ (79,238) | $ (13,329) | $ 613,670 | $ (158,650) | $ (222,693) |
Net income (loss) per share - basic (in dollars per share) | $ 0.93 | $ 3.65 | $ (0.12) | $ (0.98) | $ 0.15 | $ (0.55) | $ (0.49) | $ (0.08) | $ 3.51 | $ (0.96) | $ (1.41) |
Net income (loss) per share - diluted (in dollars per share) | $ 0.90 | $ 3.50 | $ (0.12) | $ (0.98) | $ 0.14 | $ (0.55) | $ (0.49) | $ (0.08) | $ 3.37 | $ (0.96) | $ (1.41) |
Net income (loss) per share - S
Net income (loss) per share - Schedule of net income (loss) per share (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2020 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Earnings Per Share [Abstract] | |||||||||||
Net income (loss) | $ 167,095 | $ 636,167 | $ (21,190) | $ (168,402) | $ 25,830 | $ (91,913) | $ (79,238) | $ (13,329) | $ 613,670 | $ (158,650) | $ (222,693) |
Weighted average common shares outstanding - basic (in shares) | 174,834 | 165,498 | 157,655 | ||||||||
Effect of potentially dilutive common shares (in shares) | 7,453 | 0 | 0 | ||||||||
Weighted average common shares outstanding - diluted (in shares) | 182,287 | 165,498 | 157,655 | ||||||||
Net income (loss) per share - basic (in dollars per share) | $ 0.93 | $ 3.65 | $ (0.12) | $ (0.98) | $ 0.15 | $ (0.55) | $ (0.49) | $ (0.08) | $ 3.51 | $ (0.96) | $ (1.41) |
Net income (loss) per share - diluted (in dollars per share) | $ 0.90 | $ 3.50 | $ (0.12) | $ (0.98) | $ 0.14 | $ (0.55) | $ (0.49) | $ (0.08) | $ 3.37 | $ (0.96) | $ (1.41) |
Net income (loss) per share - A
Net income (loss) per share - Antidilutive shares (Details) - shares shares in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Stock Options and RSUs [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Weighted-average shares that have been excluded (in shares) | 356 | 12,774 | 13,439 |
Uncategorized Items - sgen-2020
Label | Element | Value |
Accounting Standards Update [Extensible List] | us-gaap_AccountingStandardsUpdateExtensibleList | us-gaap:AccountingStandardsUpdate201601Member |