Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Jan. 31, 2022 | Jun. 30, 2021 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Document Period End Date | Dec. 31, 2021 | ||
Documents Incorporated by Reference | Part III incorporates by reference certain information from the registrant’s definitive proxy statement for the 2022 Annual Meeting of Stockholders. | ||
Entity File Number | 001-36721 | ||
Entity Registrant Name | Coherus BioSciences, Inc. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 27-3615821 | ||
Entity Address, Address Line One | 333 Twin Dolphin Drive | ||
Entity Address, Address Line Two | Suite 600 | ||
Entity Address, City or Town | Redwood City | ||
Entity Address, State or Province | CA | ||
Entity Address, Postal Zip Code | 94065 | ||
City Area Code | 650 | ||
Local Phone Number | 649 - 3530 | ||
Title of 12(b) Security | Common Stock, $0.0001 par value per share | ||
Trading Symbol | CHRS | ||
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 | ||
ICFR Auditor Attestation Flag | true | ||
Auditor Name | Ernst & Young LLP | ||
Auditor Firm ID | 42 | ||
Auditor Location | Redwood City, California | ||
Entity Small Business | false | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Common Stock, Shares Outstanding | 77,275,299 | ||
Entity Public Float | $ 836,606,033 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2021 | ||
Document Fiscal Period Focus | FY | ||
Entity Central Index Key | 0001512762 | ||
Amendment Flag | false |
Balance Sheets
Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 417,195 | $ 541,158 |
Trade receivables, net | 123,022 | 157,046 |
Inventory | 37,642 | 44,233 |
Prepaid manufacturing | 13,666 | 19,429 |
Other prepaid and other assets | 10,798 | 5,613 |
Total current assets | 602,323 | 767,479 |
Property and equipment, net | 7,813 | 10,108 |
Inventory, non-current | 55,610 | 47,956 |
Intangible assets | 2,620 | 2,620 |
Goodwill | 943 | 943 |
Other assets, non-current | 10,025 | 12,543 |
Total assets | 679,334 | 841,649 |
Current liabilities: | ||
Accounts payable | 16,159 | 15,201 |
Accrued rebates, fees and reserve | 79,027 | 81,529 |
Accrued compensation | 22,014 | 22,244 |
Accrued and other current liabilities | 48,127 | 26,679 |
Total current liabilities | 165,327 | 145,653 |
2022 Convertible Notes | 81,359 | 79,885 |
2022 Convertible Notes - related parties | 27,120 | 26,628 |
2026 Convertible Notes | 224,288 | 223,029 |
2025 Term loan | 75,513 | 74,481 |
Lease liabilities, non-current | 7,251 | 9,948 |
Other liabilities, non-current | 750 | 1,051 |
Total liabilities | 581,608 | 560,675 |
Commitments and contingencies (Note 8) | ||
Stockholders' equity: | ||
Common stock ($0.0001 par value; shares authorized: 300,000,000; shares issued and outstanding: 76,930,096 and 72,513,348 at December 31, 2021 and 2020, respectively) | 7 | 7 |
Additional paid-in capital | 1,147,843 | 1,043,991 |
Accumulated other comprehensive loss | (270) | (270) |
Accumulated deficit | (1,049,854) | (762,754) |
Total stockholders' equity | 97,726 | 280,974 |
Total liabilities and stockholders' equity | $ 679,334 | $ 841,649 |
Balance Sheets (Parentheticals)
Balance Sheets (Parentheticals) - $ / shares | Dec. 31, 2021 | Dec. 31, 2020 |
Balance Sheets | ||
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 300,000,000 | 300,000,000 |
Common stock, shares issued | 76,930,096 | 72,513,348 |
Common stock, shares outstanding | 76,930,096 | 72,513,348 |
Statements of Operations
Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Revenue: | |||
Net product revenue | $ 326,551 | $ 475,824 | $ 356,071 |
Cost and expenses: | |||
Cost of goods sold | 57,591 | 37,667 | 17,078 |
Research and development | 363,105 | 142,759 | 94,188 |
Selling, general and administrative | 169,713 | 139,079 | 137,037 |
Total cost and expenses | 590,409 | 319,505 | 248,303 |
(Loss) income from operations | (263,858) | 156,319 | 107,768 |
Interest expense (includes related party expense of $2,541, $2,498 and $2,457 for the years ended December 31, 2021, 2020 and 2019, respectively) | (22,959) | (21,166) | (17,601) |
Other (expense) income, net | (283) | 554 | 2,608 |
Net (loss) income before income taxes | (287,100) | 135,707 | 92,775 |
Income tax provision | 0 | 3,463 | 2,942 |
Net (loss) income | $ (287,100) | $ 132,244 | $ 89,833 |
Net (loss) income per share: | |||
Basic | $ (3.81) | $ 1.85 | $ 1.29 |
Diluted | $ (3.81) | $ 1.62 | $ 1.23 |
Weighted-average number of shares used in computing net (loss) income per share: | |||
Basic | 75,449,632 | 71,411,705 | 69,679,916 |
Diluted | 75,449,632 | 83,491,898 | 73,185,943 |
Product Revenue | |||
Revenue: | |||
Net product revenue | $ 326,600 | $ 475,800 | $ 356,100 |
Statements of Operations (Paren
Statements of Operations (Parenthetical) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Statements of Operations | |||
Interest expense from transactions with related party | $ 2,541 | $ 2,498 | $ 2,457 |
Statements of Comprehensive (Lo
Statements of Comprehensive (Loss) Income - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Statements of Comprehensive (Loss) Income | |||
Net (loss) income | $ (287,100) | $ 132,244 | $ 89,833 |
Other comprehensive (loss) income: | |||
Foreign currency translation adjustments, net of tax | 288 | (276) | |
Comprehensive (loss) income | $ (287,100) | $ 132,532 | $ 89,557 |
Statements of Stockholders' Equ
Statements of Stockholders' Equity (Deficit) - USD ($) | 2018 bonus payout in RSUsCommon Stock | 2018 bonus payout in RSUsAdditional Paid-In Capital | 2018 bonus payout in RSUs | 2019 bonus payout in RSUsCommon Stock | 2019 bonus payout in RSUsAdditional Paid-In Capital | 2019 bonus payout in RSUs | Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive LossCumulative translation adjustment | Accumulated Other Comprehensive Loss | Accumulated Deficit | Cumulative translation adjustment | Total |
Beginning Balances at Dec. 31, 2018 | $ 7,000 | $ 946,515,000 | $ (276,000) | $ (282,000) | $ (984,831,000) | $ (276,000) | $ (38,591,000) | ||||||
Beginning Balances (in shares) at Dec. 31, 2018 | 68,302,681 | ||||||||||||
Issuance of common stock upon exercise of stock options | 5,934,000 | 5,934,000 | |||||||||||
Issuance of common stock upon exercise of stock options (in shares) | 863,940 | ||||||||||||
Issuance of common stock upon vesting of RSUs | $ 2,165,000 | $ 2,165,000 | |||||||||||
Issuance of common stock upon vesting of RSUs (in shares) | 175,054 | 39,765 | |||||||||||
Stock-based compensation expense | 35,218,000 | 35,218,000 | |||||||||||
Issuance of common stock in connection with common stock offerings, net of underwriters discounts, commissions and offering costs | 8,228,000 | 8,228,000 | |||||||||||
Issuance of common stock in connection with common stock offerings, net of underwriters discounts, commissions and offering costs (in shares) | 761,130 | ||||||||||||
Issuance of common stock under the ESPP | $ 289,977 | 3,518,000 | 3,518,000 | ||||||||||
Taxes paid related to net share settlement of bonus payout in RSUs | (815,000) | (815,000) | |||||||||||
Taxes paid related to net share settlement of RSUs (in shares) | (65,886) | ||||||||||||
Cumulative translation adjustment | (276,000) | ||||||||||||
Net (loss) income | 89,833,000 | 89,833,000 | |||||||||||
Ending Balances at Dec. 31, 2019 | $ 7,000 | 1,000,763,000 | $ 288,000 | (558,000) | (894,998,000) | $ 288,000 | 105,214,000 | ||||||
Ending Balances (in shares) at Dec. 31, 2019 | 70,366,661 | ||||||||||||
Issuance of common stock upon exercise of stock options | 17,061,000 | 17,061,000 | |||||||||||
Issuance of common stock upon exercise of stock options (in shares) | 1,704,764 | ||||||||||||
Issuance of common stock upon vesting of RSUs (in shares) | 89,668 | ||||||||||||
Stock-based compensation expense | 39,038,000 | 39,038,000 | |||||||||||
Issuance of common stock in connection with common stock offerings, net of underwriters discounts, commissions and offering costs | $ 2,378,000 | $ 2,378,000 | |||||||||||
Issuance of common stock in connection with common stock offerings, net of underwriters discounts, commissions and offering costs (in shares) | 134,099 | ||||||||||||
Issuance of common stock under the ESPP | 3,801,000 | 3,801,000 | |||||||||||
Issuance of common stock under the ESPP (in shares) | 267,772 | ||||||||||||
Taxes paid related to net share settlement of bonus payout in RSUs | (880,000) | (880,000) | |||||||||||
Taxes paid related to net share settlement of RSUs (in shares) | (49,616) | ||||||||||||
Cumulative translation adjustment | 288,000 | ||||||||||||
Net (loss) income | 132,244,000 | 132,244,000 | |||||||||||
Ending Balances at Dec. 31, 2020 | $ 7,000 | 1,043,991,000 | (270,000) | (762,754,000) | $ 280,974,000 | ||||||||
Ending Balances (in shares) at Dec. 31, 2020 | 72,513,348 | 72,513,348 | |||||||||||
Issuance of common stock upon exercise of stock options | 10,410,000 | $ 10,410,000 | |||||||||||
Issuance of common stock upon exercise of stock options (in shares) | 1,316,361 | ||||||||||||
Issuance of common stock upon vesting of RSUs (in shares) | 465,930 | ||||||||||||
Stock-based compensation expense | 51,290,000 | 51,290,000 | |||||||||||
Issuance of common stock in connection with common stock offerings, net of underwriters discounts, commissions and offering costs | 40,903,000 | 40,903,000 | |||||||||||
Issuance of common stock in connection with common stock offerings, net of underwriters discounts, commissions and offering costs (in shares) | 2,491,988 | ||||||||||||
Issuance of common stock under the ESPP | 3,002,000 | 3,002,000 | |||||||||||
Issuance of common stock under the ESPP (in shares) | 238,934 | ||||||||||||
Taxes paid related to net share settlement of bonus payout in RSUs | (1,753,000) | (1,753,000) | |||||||||||
Taxes paid related to net share settlement of RSUs (in shares) | (96,465) | ||||||||||||
Purchase of capped call options related to convertible notes due 2026 | (18,170,000) | (18,170,000) | |||||||||||
Net (loss) income | (287,100,000) | (287,100,000) | |||||||||||
Ending Balances at Dec. 31, 2021 | $ 7,000 | $ 1,147,843,000 | $ (270,000) | $ (1,049,854,000) | $ 97,726,000 | ||||||||
Ending Balances (in shares) at Dec. 31, 2021 | 76,930,096 | 76,930,096 |
Statements of Cash Flows
Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Operating activities | |||
Net (loss) income | $ (287,100) | $ 132,244 | $ 89,833 |
Adjustments to reconcile net (loss) income to net cash (used in) provided by operating activities: | |||
Depreciation and amortization | 3,454 | 2,888 | 3,259 |
Stock-based compensation expense | 51,364 | 38,160 | 33,591 |
Write-off of prepaid manufacturing services related to the termination of CHS-2020 | 3,210 | ||
Write-off of inventory that did not meet acceptance criteria | 5,133 | 2,171 | 395 |
Non-cash accretion of discount on marketable securities | 1,095 | (155) | (165) |
Non-cash interest expense from amortization of debt discount | 4,257 | 3,481 | 2,339 |
Non-cash operating lease expense | 2,207 | 2,081 | 1,789 |
Upfront license fee payment to Junshi Biosciences | 136,000 | ||
Upfront and milestone based license fee payments | 7,500 | 11,075 | |
Other non-cash adjustments | 588 | 426 | 562 |
Changes in operating assets and liabilities: | |||
Trade receivables, net | 34,062 | (15,218) | (141,992) |
Inventory | (6,253) | (38,359) | (48,579) |
Prepaid manufacturing | 3,828 | (10,851) | (672) |
Other prepaid, current and non-current assets | (5,351) | (2,020) | (2,474) |
Accounts payable | 874 | (9,820) | 9,893 |
Accrued rebates, fees and reserves | (2,502) | 30,409 | 51,120 |
Accrued compensation | (230) | 6,212 | 10,035 |
Accrued and other current and non-current liabilities | 17,932 | 4,996 | 8,346 |
Net cash (used in) provided by operating activities | (37,432) | 154,145 | 28,355 |
Investing activities | |||
Purchases of property and equipment | (1,289) | (7,231) | (1,822) |
Proceeds from disposal of property and equipment | 175 | ||
Purchases of investments in marketable securities | (182,485) | (273,845) | (20,235) |
Proceeds from maturities of investments in marketable securities | 99,692 | 274,000 | 20,400 |
Proceeds from sale of investments in marketable securities | 81,672 | ||
Upfront license fee payment to Junshi Biosciences | (136,000) | ||
Upfront and milestone based license fee payments | (7,500) | (11,075) | |
Net cash used in investing activities | (138,410) | (14,401) | (12,732) |
Financing activities | |||
Proceeds from common stock offering, net of underwriters discounts, commissions and offering costs | 8,153 | ||
Proceeds from issuance of Convertible Notes | 222,156 | ||
Purchase of capped call options related to Convertible Notes due 2026 | (18,170) | ||
Proceeds from issuance of common stock to Junshi Biosciences, net of issuance costs | 40,903 | ||
Proceeds from term loan, net of issuance costs | 72,955 | ||
Proceeds from issuance of common stock upon exercise of stock options | 10,399 | 17,428 | 5,558 |
Proceeds from purchase under the employee stock purchase plan | 3,002 | 3,801 | 3,519 |
Taxes paid related to net share settlement of RSUs | (1,753) | (880) | (815) |
Principal payments for finance lease obligations | (672) | (389) | |
Net cash provided by financing activities | 51,879 | 223,946 | 89,370 |
Effect of exchange rate changes in cash, cash equivalents and restricted cash | (276) | ||
Net (decrease) increase in cash, cash equivalents and restricted cash | (123,963) | 363,690 | 104,717 |
Cash, cash equivalents and restricted cash, beginning of period | 541,598 | 177,908 | 73,191 |
Cash, cash equivalents and restricted cash at end of period | 417,635 | 541,598 | 177,908 |
Supplemental disclosure of cash flow information | |||
Cash paid for interest | 18,684 | 16,959 | 15,263 |
Cash paid for income taxes | 1,221 | 3,953 | 1,732 |
Non-cash bonus payment settled in common stock | 1,498 | 1,350 | |
Right-of-use assets obtained in exchange for lease obligations related to operating leases | 434 | 1,388 | 5,267 |
Right-of-use assets obtained in exchange for lease obligations related to finance leases | 477 | 1,817 | |
Supplemental disclosures of non-cash investing and financing activities | |||
Purchase of property and equipment in accounts payable and accrued liabilities | $ 119 | $ 109 | $ 999 |
Organization and Summary of Sig
Organization and Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2021 | |
Organization and Summary of Significant Accounting Policies | |
Organization and Summary of Significant Accounting Policies | Coherus BioSciences, Inc. Notes to Consolidated Financial Statements 1. Description of the Business Coherus BioSciences, Inc. (the “Company” or “Coherus”) is a commercial-stage biopharmaceutical company focused on the research, development and commercialization of innovative immunotherapies to treat cancer. The Company’s strategy is to build a leading immuno-oncology franchise funded with cash generated through net sales of its diversified portfolio of FDA-approved therapeutics. The Company’s headquarters and laboratories are located in Redwood City, California and in Camarillo, California, respectively. The Company sells UDENYCA, a biosimilar to Neulasta, a long-acting granulocyte-colony stimulating factor, in the United States. The FDA-approved YUSIMRY in December 2021, which the Company plans to launch in the United States on or after July 1, 2023, per the terms of an agreement with Humira manufacturer, AbbVie. The Company’s product pipeline comprises three product candidates, toripalimab, an anti-PD-1 antibody being developed in collaboration with Junshi Biosciences Co., Ltd., CIMERLI, a Lucentis biosimilar candidate in-licensed for commercial rights in the United States and Canada from Bioeq, and a bevacizumab (Avastin) biosimilar in-licensed for commercial rights in the United States from Innovent Biologics (Suzhou) Co., Ltd. Basis of Consolidation The accompanying consolidated financial statements have been prepared in accordance with U.S. GAAP and include the accounts of Coherus and its wholly-owned subsidiaries. The Company does not have any significant interests in variable interest entities. All material intercompany transactions and balances have been eliminated upon consolidation. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make judgements, estimates and assumptions that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosures. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances. These estimates form the basis for making judgments about the carrying values of assets and liabilities when these values are not readily apparent from other sources. Estimates are assessed each period and updated to reflect current information, such as the economic considerations related to the impact that the recent COVID-19 outbreak could have on the Company’s significant accounting estimates. Accounting estimates and judgements are inherently uncertain and the actual results could differ from these estimates. Segment Reporting and Revenue by Geographic Region The Company operates and manages its business as one reportable and operating segment, which is the business of developing and commercializing human pharmaceutical products. The Company’s chief executive officer, who is the chief operating decision maker, reviews financial information on an aggregate basis for purposes of allocating resources and evaluating financial performance. All revenue is generated and all long-lived assets are primarily maintained in the United States. Cash, Cash Equivalents and Restricted Cash Cash, cash equivalents and restricted cash comprise cash and highly liquid investments with original maturities of 90 days or less. The following table provides a reconciliation of cash, cash equivalents and restricted cash within the consolidated balance sheets and which, in aggregate, represent the amount reported in the consolidated statements of cash flows: Year Ended December 31, (in thousands) 2021 2020 2019 At beginning of period: Cash and cash equivalents $ 541,158 $ 177,668 $ 72,356 Restricted cash 440 240 835 Total cash, cash equivalents and restricted cash $ 541,598 $ 177,908 $ 73,191 At end of period: Cash and cash equivalents $ 417,195 $ 541,158 $ 177,668 Restricted cash 440 440 240 Total cash, cash equivalents and restricted cash $ 417,635 $ 541,598 $ 177,908 Restricted cash consists of deposits for letters of credit that the Company has provided to secure its obligations under certain leases and is included in other assets, non-current on the consolidated balance sheets. The Company classifies the up-front and milestone payments related to licensing arrangements as cash flows from investing activities in its consolidated statements of cash flows. Investments in Marketable Securities Investments in marketable securities primarily consist of corporate debt obligations and commercial paper. Management determines the appropriate classification of investments in marketable securities at the time of purchase based upon management’s intent with regards to such investment and reevaluates such designation as of each balance sheet date. The Company’s investment policy requires that it only invests in highly rated securities and limit its exposure to any single issuer. All investments in marketable debt securities are held as available-for-sale and are carried at the estimated fair value as determined based upon quoted market prices or pricing models for similar securities. The Company classifies investments in marketable securities as short-term when they have remaining contractual maturities of one year or less from the balance sheet date. The Company periodically assesses its marketable securities for impairment and credit losses. Unrealized gains and losses on available-for-sale securities are reported as a component of accumulated comprehensive income (loss), with the exception of unrealized losses believed to be related to credit losses, if any, which are recognized in earnings in the period the impairment occurs. Impairment assessments are made at the individual security level each reporting period. When the fair value of an investment is less than its cost at the balance sheet date, a determination is made as to whether the impairment is related to a credit loss and, if it is, the portion of the impairment relating to credit loss is recorded as an allowance through net income. Realized gains and losses and declines in value, if any, on available-for-sale securities are included in other (expense) income, net, based on the specific identification method. During 2021, 2020 and 2019, interest income from marketable securities was $1.4 million, $0.6 million and $1.6 million, respectively. Trade Receivables Trade receivables are recorded net of allowances for chargebacks, chargeback prepayments, cash discounts for prompt payment and credit losses. The Company estimates an allowance for expected credit losses 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. The corresponding expense for the credit loss allowance is reflected in selling, general and administrative expenses. The credit loss allowance was immaterial as of December 31, 2021 and 2020. Concentrations of Risk The Company’s financial instruments that are exposed to concentration of credit risk consist primarily of cash, cash equivalents, investments and accounts receivable. The Company attempts to minimize the risks related to cash, cash equivalents and investments by investing in a broad and diverse range of financial instruments. The investment portfolio is maintained in accordance with the Company’s investment policy, which defines allowable investments, specifies credit quality standards and limits the credit exposure of any single issuer. There were no material losses from credit risks on such accounts during any of the periods presented. The Company is not exposed to any significant concentrations of credit risk from these financial instruments. The Company is subject to credit risk from trade receivables related to product sales and monitors the credit worthiness of customers that are granted credit in the normal course of business. In general, there is no requirement for collateral from customers. The Company has not experienced significant losses with respect to the collection of trade receivables. The Company believes that its allowance for expected credit losses was adequate at December 31, 2021. The Company entered into a strategic commercial supply agreement with KBI Biopharma for the supply of UDENYCA. The Company currently has not engaged back-up suppliers or vendors for this single-sourced service. If KBI Biopharma is not able to manufacture the supply needed in the quantities and timeframe required, the Company may not be able to supply the product in a timely manner. Substantially all of the Company’s revenues are in the United States to three wholesalers. UDENYCA is currently the only product sold by the Company and accounted for all of the Company’s revenues in 2021, 2020 and 2019. The Company has no significant monetary assets or liabilities in foreign currencies, and the Company has not had material foreign currency impacts for all years presented. Inventory Inventory is stated at the lower of cost or estimated net realizable value with cost determined under the first-in first-out method. Inventory costs include third-party contract manufacturing, third-party packaging services, freight, labor costs for personnel involved in the manufacturing process, and indirect overhead costs. The Company primarily uses actual costs to determine the cost basis for inventory. The determination of excess or obsolete inventory requires judgment including consideration of many factors, such as estimates of future product demand, current and future market conditions, product expiration information, and potential product obsolescence, among others. Although the Company believes the assumptions used in estimating potential inventory write-downs are reasonable, if actual market conditions are less favorable than projected by management, write-downs of inventory, charges related to firm purchase commitments, or both may be required which would be recorded as cost of goods sold in the consolidated statement of operations. Adverse developments affecting the Company’s assumptions of the level and timing of demand for its products include those that are outside of the Company’s control such as the actions taken by competitors and customers, the direct or indirect effects of the COVID-19 pandemic, and other factors. Prior to the regulatory approval of our product candidates, the Company incurred expenses for the manufacture of drug product that could potentially be available to support the commercial launch of our products. I nventory costs are capitalized when future commercialization is considered probable and the future economic benefit is expected to be realized, based on management’s judgment. A number of factors are considered, including the current status in the regulatory approval process, potential impediments to the approval process such as safety or efficacy, viability of commercialization and marketplace trends. All inventory on the consolidated balance sheet as of December 31, 2021 was related to UDENYCA. Property and Equipment Property and equipment is stated at cost less accumulated depreciation and amortization. Maintenance and repairs are charged to expense as incurred. Interest costs incurred during the construction of major capital projects are capitalized until the underlying asset is ready for its intended use, at which point the capitalized interest costs are amortized as depreciation or amortization expense over the life of the underlying asset. When the Company disposes of property and equipment, it removes the associated cost and accumulated depreciation from the related accounts in the consolidated balance sheets and include any resulting gain or loss in the consolidated statements of operations. Eligible costs of internal use software and implementation costs of certain hosting arrangements are capitalized and amortized over the estimated useful life of the software or associated hosting arrangement, as applicable. Depreciation and amortization are recognized using the straight-line method over the following estimated useful lives: Computer equipment and software 3 - 7 years Furniture and fixtures 5 years Machinery and equipment 5 years Leasehold improvements Shorter of lease term or useful life Goodwill and Intangible Assets Goodwill represents the excess of the consideration transferred over the estimated fair value of assets acquired and liabilities assumed in a business combination. Intangible assets are measured at their respective fair values as of the acquisition date and may be subject to adjustment within the measurement period, which may be up to one year from the acquisition date. Intangible assets related to acquired in-process research and development (“IPR&D”) projects are considered to be indefinite-lived until the completion or abandonment of the associated research and development efforts. Goodwill and intangible assets with indefinite useful lives are not amortized and are tested for impairment annually, or more frequently if events or changes in circumstances indicate that it is more likely than not that the assets are impaired. Intangible assets of $2.6 million as of December 31, 2021 and 2020 consist of IPR&D. There were no impairments to goodwill or intangible assets When development is successfully completed, which generally occurs when regulatory approval is obtained, the associated assets are deemed finite-lived and amortized over their respective estimated useful lives beginning at that point in time. Intangible assets with finite useful lives are amortized over their estimated useful lives, primarily on a straight-line basis, and are reviewed for impairment when facts or circumstances indicate that the carrying value of these assets may not be recoverable. Impairment of Long-Lived Assets Long-lived assets, including property and equipment and finite-lived intangible assets, are reviewed for impairment whenever facts or circumstances either internally or externally may indicate that the carrying value of an asset may not be recoverable. If there is an indication of impairment, the Company tests for recoverability by comparing the estimated undiscounted future cash flows expected to result from the use of the asset to the carrying amount of the asset or asset group. If the asset or asset group is determined to be impaired, any excess of the carrying value of the asset or asset group over its estimated fair value is recognized as an impairment loss. There were no material impairments recorded during the years ended December 31, 2021, 2020 and 2019. Accrued Research and Development Expense Clinical trial costs are a component of research and development expense. The Company accrues and expenses clinical trial activities performed by third parties based upon actual work completed in accordance with agreements established with clinical research and manufacturing organizations and clinical sites. The Company determines the actual costs through monitoring patient enrollment, discussions with internal personnel and external service providers regarding the progress or stage of completion of trials or services and the agreed-upon fee to be paid for such services. Net Revenues The Company sells to wholesalers and distributors, (collectively, “Customers”). The Customers then resell to hospitals and clinics (collectively, “Healthcare Providers”) pursuant to contracts with the Company. In addition to distribution agreements with Customers and contracts with Healthcare Providers, the Company enters into arrangements with group purchasing organizations (“GPOs”) that provide for United States government-mandated or privately-negotiated rebates, chargebacks and discounts. The Company also enters into rebate arrangements with payers, which consist primarily of commercial insurance companies and government entities, to cover the reimbursement of our products to Healthcare Providers. The Company provides co-payment assistance to patients who have commercial insurance and meet certain eligibility requirements. Revenue from product sales is recognized at the point when a Customer obtains control of the product and the Company satisfies its performance obligation, which generally occurs at the time product is shipped to the Customer. Payment terms differ by jurisdiction and customer, but payment terms typically range from 30 to 67 days from date of shipment. Product Sales Discounts and Allowances Revenue from product sales is recorded at the net sales price (“transaction price”), which includes estimates of variable consideration for which reserves are established and that result from chargebacks, rebates, co-pay assistance, prompt-payment discounts, returns and other allowances that are offered within contracts between the Company and its Customers, Healthcare Providers, payers and GPOs. These reserves are based on the amounts earned or to be claimed on the related sales and are classified as reductions in trade receivables (if the amounts are payable to a Customer) or current liabilities (if the amounts are payable to a party other than a Customer). Where appropriate, these estimates take into consideration a range of possible outcomes that are probability-weighted for relevant factors such as historical experience, current contractual and statutory requirements, specifically known market events and trends, industry data and forecasted Customer buying and payment patterns. Overall, these reserves reflect the best estimates of the amount of consideration to which the Company is entitled based on the terms of its contracts. The amount of variable consideration that is included in the transaction price may be constrained, and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. The actual amount of consideration ultimately received may differ. If actual results in the future vary from the Company’s estimates, the estimates will be adjusted, which will affect net product revenue in the period that such variances become known. Chargebacks: Discounts for Prompt Payment: Rebates: Co-payment Assistance: Product Returns: Other Allowances: Royalty Revenue Royalty revenue from licensees, which is based on sales to third-parties of licensed products, is recorded when the third-party sale occurs and the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). Royalty revenue was insignificant for the periods presented and is included in total revenues. Cost of Goods Sold Cost of goods sold consists primarily of third-party manufacturing, distribution, and certain overhead costs. A portion of the costs of producing UDENYCA sold to date was expensed as research and development prior to the FDA approval of UDENYCA and, therefore, it is not reflected in the cost of goods sold. During the first quarter of 2021, the UDENYCA inventory with no inventory value was fully utilized. On May 2, 2019, the Company and Amgen settled a trade secret action brought by Amgen. As a result, cost of goods sold reflects a mid-single digit royalty on net product revenue, which began on July 1, 2019. The royalty cost will continue for five years pursuant to the settlement. In 2021, 2020 and 2019, cost of goods sold included write-offs for inventory of $5.1 million, $2.2 million and $0.4 million, respectively, that did not meet the Company’s acceptance criteria, net of credits received from manufacturers. In 2019, cost of goods sold included write-off of prepaid manufacturing costs of $1.3 million due to the cancellation of certain manufacturing reservations. Research and Development Expense Research and development expense represents costs incurred to conduct research, such as the discovery and development of our product candidates. The Company recognizes all research and development costs as they are incurred. The Company currently tracks research and development costs incurred on a product candidate basis only for external research and development expenses. The Company’s external research and development expense consists primarily of: ● expense incurred under agreements with consultants, third-party CROs, and investigative sites where a substantial portion of the Company’s preclinical studies and all of its clinical trials are conducted; ● costs of acquiring originator comparator materials and manufacturing preclinical study and clinical trial supplies and other materials from CMOs, and related costs associated with release and stability testing; ● costs associated with manufacturing process development activities; and ● upfront and milestone payments related to licensing and collaboration agreements. Internal costs are associated with activities performed by the Company’s research and development organization and generally benefit multiple programs. These costs are not separately allocated by product candidate. Unallocated, internal research and development costs consist primarily of: ● personnel-related expense, which include salaries, benefits and stock-based compensation; and ● facilities and other allocated expense, which include direct and allocated expense for rent and maintenance of facilities, depreciation and amortization of leasehold improvements and equipment, laboratory and other supplies. Products manufactured prior to regulatory approval may not be sold unless regulatory approval is obtained. The Company expenses manufacturing costs as incurred as research and development expense for products that have not been approved until future commercialization is considered probable and the future economic benefit is expected to be realized, based on management’s judgment. The Company began to capitalize inventory costs associated with UDENYCA after receiving regulatory approval in November 2018. License Agreements The Company has entered and may continue to enter into license agreements to access and utilize certain technology. To determine whether the licensing transactions should be accounted for as a business combination or as an asset acquisition, the Company makes certain judgments, which include assessing whether the acquired set of activities and assets would meet the definition of a business under the relevant accounting rules. If the acquired set of activities and assets does not meet the definition of a business, the transaction is recorded as an asset acquisition and therefore, any acquired IPR&D that does not have an alternative future use is charged to expense at the acquisition date. To date none of the Company’s license agreements have been considered to be the acquisition of a business. Selling, General and Administrative Expense Selling, general and administrative expenses comprise primarily compensation and benefits associated with sales and marketing, finance, human resources, legal, information technology and other administrative personnel, outside marketing, advertising and legal expenses and other general and administrative costs. The Company expenses the cost of advertising, including promotional expenses, as incurred. Advertising expenses were $8.7 million, $3.8 million and $4.5 million in 2021, 2020 and 2019, respectively. Stock-Based Compensation The Company’s compensation programs include stock-based awards, and the related grants under these programs are accounted for at fair value. The fair values are recognized as compensation expense on a straight-line basis over the vesting period with the related costs recorded in cost of goods sold, research and development, and selling, general and administrative expense, as appropriate. The Company accounts for forfeitures as they occur. Income Taxes The Company utilizes the liability method of accounting for deferred income taxes. Under this method, deferred tax liabilities and assets are recognized for the expected future tax consequences of temporary differences between the carrying amounts and the tax basis of assets and liabilities. A valuation allowance is established against deferred tax assets because, based on the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. The Company’s policy is to record interest and penalties on uncertain tax positions as income tax expense. The Company recognizes uncertain income tax positions at the largest amount that is more likely than not to be sustained upon audit by the relevant taxing authority. The Company does not expect its unrecognized tax benefits to change significantly in 2022. Operating and Finance Leases The Company determines if an arrangement is a lease at inception. The Company does not recognize right-of-use assets and lease liabilities related to short-term leases. The Company also does not separate lease and non-lease components for its facility and vehicle leases. Operating leases are included in other current liabilities, other assets, non-current, and lease liabilities, non-current in the consolidated balance sheets. The lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise any such options. The Company recognizes operating lease expense for these leases on a straight-line basis over the term of the lease. The term under the Company’s vehicle lease agreement is 36 months. The vehicles leased under this arrangement were classified as finance leases. Finance leases are included in property and equipment, net, accrued and other current liabilities, and lease liabilities, non-current in the consolidated balance sheets and assets under Finance leases are depreciated to operating expenses on a straight-line basis over their estimated useful lives. The operating and finance lease right-of-use assets and the lease liabilities are recognized based on the present value of lease payments over the lease term at the lease commencement date. The Company uses its incremental borrowing rate based on the information available at the commencement date in determining the lease liabilities as the Company's leases generally do not provide an implicit rate. Net (Loss) Income per Share Basic net (loss) income per share is calculated by dividing the net (loss) income by the weighted-average number of shares of common stock outstanding for the period, without consideration for potential dilutive common shares. Diluted net income per share is computed by dividing the net income by the weighted-average number of common shares outstanding for the period plus any potential dilutive common shares outstanding for the period determined using the treasury stock method for options, RSUs and ESPP and using the if-converted method for the convertible notes. Diluted net loss per share is computed by dividing net loss by the weighted-average number of common shares outstanding for the period, without consideration for any potential dilutive common share equivalents as their effect would be antidilutive Comprehensive (Loss) Income Comprehensive (loss) income is composed of two components: net (loss) income and other comprehensive (loss) income. Other comprehensive (loss) income refers to gains and losses that under U.S. GAAP are recorded as an element of stockholders’ equity, but are excluded from net (loss) income. The Company’s other comprehensive (loss) income include foreign currency translation adjustments in 2021, 2020 and 2019. Reclassifications Certain prior year amounts in the consolidated balance sheets and consolidated statements of cash flows have been reclassified to conform with the current year presentation in 2021. As a result, there was no change to total assets on the consolidated balance sheet or net cash provided by operating activities on the consolidated statements of cash flows for the prior years. Recent Accounting Pronouncements In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes In October 2020, the FASB issued ASU 2020-10, Codification Improvements The Company has reviewed other recent accounting pronouncements and concluded they are either not applicable to the business or that no material effect is expected on the consolidated financial statements as a result of future adoption. |
Revenue
Revenue | 12 Months Ended |
Dec. 31, 2021 | |
Revenue | |
Revenue | 2. The Company initiated United States sales of UDENYCA on January 3, 2019. The Company recorded net revenue of $326.6 million, $475.8 million and $356.1 million during 2021, 2020 and 2019, respectively. Revenue by significant Customer was distributed as follows: Year Ended December 31, 2021 2020 2019 McKesson Corporation 39 % 38 % 42 % AmeriSource-Bergen Corporation 39 % 37 % 33 % Cardinal Health, Inc. 20 % 23 % 23 % Others 2 % 2 % 2 % Total revenue 100 % 100 % 100 % Product Sales Discounts and Allowances The activities and ending reserve balances for each significant category of discounts and allowances, which constitute variable consideration, were as follows: Year Ended December 31, 2021 Chargebacks Other Fees, and Discounts Co-pay for Prompt Assistance (in thousands) Payment Rebates and Returns Total Balance at December 31, 2020 $ 40,580 $ 54,058 $ 28,760 $ 123,398 Provision related to sales made in: Current period 470,791 113,705 94,703 679,199 Prior period (2,876) (4,976) (3,555) (11,407) Payments and customer credits issued (478,830) (108,783) (93,854) (681,467) Balance at December 31, 2021 $ 29,665 $ 54,004 $ 26,054 $ 109,723 Year Ended December 31, 2020 Chargebacks Other Fees, and Discounts Co-pay for Prompt Assistance (in thousands) Payment Rebates and Returns Total Balance at December 31, 2019 $ 35,159 $ 27,494 $ 24,494 $ 87,147 Provision related to sales made in: Current period 462,328 115,864 114,372 692,564 Prior period (1,336) (3,438) (6,288) (11,062) Payments and customer credits issued (455,571) (85,862) (103,818) (645,251) Balance at December 31, 2020 $ 40,580 $ 54,058 $ 28,760 $ 123,398 Chargebacks and discounts for prompt payment are recorded as a reduction in trade receivables, and the remaining reserve balances are classified as current liabilities in the accompanying consolidated balance sheets. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2021 | |
Fair Value Measurements | |
Fair Value Measurements | 3. The fair value of financial instruments are classified into one of the following categories: ● Level 1 — Quoted prices in active markets for identical assets or liabilities. ● Level 2 — Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. ● Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. A financial instrument’s categorization within the valuation hierarchy is based upon the lowest level of input that is significant to the fair value measurement. Unrealized gains and losses in the Company’s investments in these money market funds There were no transfers Level 1 Level 2 Level 3 during Financial assets and liabilities measured at fair value on a recurring basis are summarized as follows: Fair Value Measurements December 31, 2021 (in thousands) Level 1 Level 2 Level 3 Total Financial Assets: Cash and cash equivalents (money market funds) $ 417,165 $ — $ — $ 417,165 Restricted cash (money market funds) 440 — — 440 Total financial assets $ 417,605 $ — $ — $ 417,605 Financial Liabilities: Contingent consideration $ — $ — $ 102 $ 102 Fair Value Measurements December 31, 2020 (in thousands) Level 1 Level 2 Level 3 Total Financial Assets: Cash and cash equivalents (money market funds) $ 538,673 $ — $ — $ 538,673 Restricted cash (money market funds) 440 — — 440 Total financial assets $ 539,113 $ — $ — $ 539,113 Financial Liabilities: Contingent consideration $ — $ — $ 102 $ 102 As part of the InteKrin acquisition in February 2014, the Company recognized contingent consideration associated with potential payments, which would be payable to the former InteKrin stockholders if the Company enters into a compound transaction agreement as defined in the InteKrin purchase agreement. In February 2020, the Company announced that it is seeking strategic alternatives to finance this program externally. As of December 31, 2021 and 2020, the $0.1 million fair value of the contingent consideration was recorded in other liabilities, non-current on the consolidated balance sheets. 1.5% Convertible Notes due 2026 The estimated fair value of the 1.5% Convertible Notes due 2026, which the Company issued in April 2020 (see Note 7. Debt Obligations) is influenced by interest rates, the Company’s stock price and stock price volatility and is determined by prices observed in market trading. The market for trading of the Convertible Notes due 2026 is not considered to be an active market and therefore the estimate of fair value is based on Level 2 inputs. The estimated fair value of the Convertible Notes due 2026 and $269.1 million (par value $230.0 million) as of December 31, 2021 and 2020, respectively. 8.2% Convertible Notes due 2022 The estimated fair value of the 8.2% Convertible Senior Notes Due 2022, which the Company issued on February 29, 2016 (see Note 7. Debt Obligations) is based on an income approach. When determining the estimated fair value of the Company’s 8.2% Convertible Notes due 2022, the Company used a single factor binomial lattice model which incorporates the terms and conditions of the convertible notes and market-based risk measurement that are indirectly observable, such as credit risk and therefore the estimate of fair value is based on Level 3 inputs. The lattice model produces an estimated fair value based on changes in the price of the underlying common shares price over successive periods of time. An estimated yield based on market data is used to discount straight debt cash flows. The estimated fair value was $108.4 million and $113.7 million (par value $100.0 million plus premium of $9.0 million) as of December 31, 2021 and 2020, respectively. 2025 Term Loan The principal amount outstanding under the Company’s 2025 Term Loan (see Note 7. Debt Obligations) as of December 31, 2021 of $75.0 million is subject to a variable interest rate, which is based on three month LIBOR (“LIBOR”) plus a fixed percentage, and as such, the Company believes the carrying amount of these obligations approximates fair value. |
Inventory
Inventory | 12 Months Ended |
Dec. 31, 2021 | |
Inventory | |
Inventory | 4. Inventory consisted of the following: December 31, (in thousands) 2021 2020 Raw Materials $ 4,870 $ 5,205 Work in process 65,117 43,952 Finished goods 23,265 43,032 Total $ 93,252 $ 92,189 Inventory expected to be sold more than twelve months from the balance sheet date is classified as inventory, non-current on the consolidated balance sheets. he non-current portion of inventory consisted of raw materials and work in process, as well as a portion of finished goods at December 31, 2020. The following table presents the inventory b December 31, (in thousands) 2021 2020 Inventory $ 37,642 $ 44,233 Inventory, non-current 55,610 47,956 Total $ 93,252 $ 92,189 Prepaid manufacturing of $13.7 million as of December 31, 2021 includes prepayments of $8.3 million to a CMO for manufacturing services for UDENYCA, which the Company expects to be converted into inventory during 2022; and prepayments of $5.4 million to various CMOs for research and development pipeline programs. Prepaid manufacturing of $19.4 million as of December 31, 2020 includes prepayments of $8.9 million to a CMO for manufacturing services for UDENYCA; and prepayments of $10.5 million to various CMOs for other research and development pipeline programs. In February 2021, the Company announced the discontinuation of the development of CHS-2020, a biosimilar of Eylea as part of a realignment of research and development resources toward other development programs. As a result, the Company recognized $11.2 million within research and development expense on the consolidated statement of operations in 2021, which included an impairment charge of $3.2 million for the write-off of prepaid manufacturing services no longer deemed to have future benefits. |
Balance Sheet Components
Balance Sheet Components | 12 Months Ended |
Dec. 31, 2021 | |
Balance Sheet Components | |
Balance Sheet Components | 5. Property and Equipment, Net Property and equipment, net consisted of the following: December 31, (in thousands) 2021 2020 Machinery and equipment $ 11,876 $ 13,301 Computer equipment and software 3,033 3,996 Furniture and fixtures 1,129 1,268 Leasehold improvements 5,942 5,830 Finance lease right of use assets 2,294 1,451 Construction in progress 388 312 Total property and equipment 24,662 26,158 Accumulated depreciation and amortization (16,849) (16,050) Property and equipment, net $ 7,813 $ 10,108 Depreciation and amortization expense was $3.5 million, $2.9 million and $3.3 million in 2021, 2020 and 2019, respectively. There were no material impairments of property and equipment in 2021, 2020 and 2019. Accrued and Other Current Liabilities Accrued and other current liabilities consisted of the following: December 31, (in thousands) 2021 2020 Accrued manufacturing and clinical $ 30,541 $ 11,365 Accrued co-development costs for toripalimab 1,926 — Accrued other 12,168 12,182 Lease liabilities, current 3,492 3,132 Total Accrued and other current liabilities $ 48,127 $ 26,679 6. |
Collaborations and Other Arrang
Collaborations and Other Arrangements | 12 Months Ended |
Dec. 31, 2021 | |
Collaborations and Other Arrangements | |
Collaborations and Other Arrangements | 6. Junshi Biosciences On February 1, 2021, the Company entered into Collaboration Agreement with Junshi Biosciences for the co-development and commercialization of toripalimab, Junshi Biosciences’ anti-PD-1 antibody, in the United States and Canada. Under the terms of the Collaboration Agreement, the Company paid $150.0 million upfront for exclusive rights to toripalimab in the United States and Canada, options in these territories to Junshi Biosciences’ anti-TIGIT antibody and next-generation engineered IL-2 cytokine, and certain negotiation rights to two undisclosed preclinical immuno-oncology drug candidates. The Company will have the right to conduct all commercial activities of toripalimab in the United States and Canada. The Company will be obligated to pay Junshi Biosciences a 20% royalty on net sales of toripalimab and up to an aggregate $380.0 million in one-time payments for the achievement of various regulatory and sales milestones. If the Company exercises its options, it will be obligated to pay an option exercise fee for each of the anti-TIGIT antibody and the IL-2 cytokine of $35.0 million per program. Additionally, for each exercised option, the Company will be obligated to pay Junshi Biosciences an 18% royalty on net sales and up to an aggregate $255.0 million for the achievement of various regulatory and sales milestones. Under the Collaboration Agreement, the Company retains the right to collaborate in the development of toripalimab and the other licensed compounds and will pay for a portion of these co-development activities up to a maximum of $25.0 million per licensed compound per year. Additionally, the Company is responsible for certain associated regulatory and technology transfer costs for toripalimab and other licensed compounds and will reimburse Junshi Biosciences for such costs. The Company recognized research and development expense of $39.4 million in the consolidated statement of operations for the year ended December 31, 2021, and had $1.9 million recorded in accrued and other current liabilities on the consolidated balance sheets as of December 31, 2021 related to the co-development, regulatory and technology transfer costs. The Company accounted for the licensing transaction as an asset acquisition under the relevant accounting rules. In addition, the Company recorded research and development expense of $145.0 million during the first quarter of 2021, related to the upfront payment for exclusive rights to toripalimab in the United States and Canada. The Company had entered into a Right of First Negotiation agreement with Junshi Biosciences and paid a fee of $5.0 million which was fully expensed as research and development expense in the fourth quarter of 2020. The Right of First Negotiation fee was fully credited against the total upfront license fee obligation under the Collaboration Agreement. As of December 31, 2021, the Company did not have any outstanding milestone or royalty payment obligations to Junshi Biosciences. In January 2022, the Company took steps that it expects will result in the payment to Junshi Biosciences of an additional $35.0 million upon the closing of the exercise of our option to license JS006, a TIGIT-targeted antibody, in the United States and Canada. The $35.0 million payment for the option to license JS006 will be reflected in our first quarter 2022 financial statements (see Note 14. Subsequent Events). The additional milestone payments, option fees and royalties are contingent upon future events and, therefore, will be recorded when it is probable that a milestone will be achieved, option fees will be incurred or when royalties are due. In connection with the Collaboration Agreement, the Company entered into the Stock Purchase Agreement with Junshi Biosciences agreeing, subject to customary conditions, to acquire certain equity interests in the Company. Pursuant to the Stock Purchase Agreement, on April 16, 2021, the Company issued 2,491,988 unregistered shares of its common stock to Junshi Biosciences, at a price per share of $20.06, for an aggregate value of approximately $50.0 million cash. Under the terms of the Stock Purchase Agreement, Junshi Biosciences is not permitted to sell, transfer, make any short sale of, or grant any option for the sale of the common stock for the two-year period following its effective date. The Collaboration Agreement and the Stock Purchase Agreement were negotiated concurrently and were therefore evaluated as a single agreement. The Company used the “Finnerty” and “Asian put” valuation models and determined the fair value for the discount for lack of marketability was $9.0 million at the date the shares were issued. The fair value of the DLOM was attributable to the Collaboration Agreement and was included as an offset against the research and development expense in the consolidated statement of operations for the year ended December 31, 2021. Innovent Biologics (Suzhou) Co., Ltd. Innovent will supply the Innovent Licensed Products to the Company in accordance with a manufacturing and supply agreement to be executed by the parties. Under the License Agreement, the Company acquired the right to require Innovent to perform technology transfer for the manufacturing of the Innovent Licensed Products in the Territory and, upon completion of such technology transfer, the Company will have the exclusive right to manufacture the Innovent Licensed Products in the Territory. Under the License Agreement, the Company committed to pay Innovent a $5.0 million upfront payment and an aggregate of up to $40.0 million in milestone payments in connection with the achievement of certain development, regulatory and sales milestones with respect to the bevacizumab Licensed Product and, if the Company’s option is exercised, an aggregate of up to $40.0 million in milestone payments in connection with the achievement of certain development, regulatory and sales milestones with respect to the rituximab Licensed Product. The Company will share a percentage of net sales of Innovent Licensed Products with Innovent in the mid-teens to low twenty percent range. If the Company exercises its option to acquire Innovent’s biosimilar version of rituximab (Rituxan), it would be required to pay a fee of $5.0 million. Subject to the terms of the License Agreement, if the Company requests Innovent to perform technology transfer for the manufacturing of the Innovent Licensed Products, it would be required to pay up to $10.0 million for fees related thereto. The Company accounted for the licensing transaction as an asset acquisition under the relevant accounting rules. The Company recorded research and development expense of $7.5 million during the year ended December 31, 2020 related to an upfront payment and a milestone payment for the bevacizumab Licensed Product. During the year ended December 31, 2021, the Company recognized research and development expense of $1.1 million related to bevacizumab Licensed Product development activities directly with Innovent. As of December 31, 2021, the Company did not have any outstanding milestone or royalty payment obligations to Innovent. The additional milestone payments, option fee for licensing of rituximab (Rituxan), manufacturing technology transfer fee and royalties are contingent upon future events and, therefore, will be recorded when such payments become probable. Bioeq On November 4, 2019, the Company entered into a license agreement with Bioeq for the commercialization of a biosimilar version of ranibizumab (Lucentis) in certain dosage forms in both a vial and pre-filled syringe presentation. Under this agreement, Bioeq granted to the Company an exclusive, royalty-bearing license to commercialize the Bioeq Licensed Products in the field of ophthalmology (and any other approved labelled indication) in the United States. Bioeq will supply to the Company the Bioeq Licensed Products in accordance with terms and conditions specified in the agreement and a manufacturing and supply agreement to be executed by the parties in accordance therewith. The agreement’s initial term continues in effect forten years after the first commercial sale of a Bioeq Licensed Product in the United States, and thereafter renews for an unlimited period of time unless otherwise terminated in accordance with its terms. Under the agreement, Bioeq must use commercially reasonable efforts to develop and obtain regulatory approval of the Bioeq Licensed Products in the United States in accordance with a development and manufacturing plan, and the Company must use commercially reasonable efforts to commercialize the Bioeq Licensed Products in accordance with a commercialization plan. Additionally, the Company must commit certain pre-launch and post-launch resources to the commercialization of the Bioeq Licensed Products for a limited time as specified in the agreement. The Company accounted for the licensing transaction as an asset acquisition under the relevant accounting rules. The Company paid Bioeq an upfront and a milestone payment aggregating to €10 million ($11.1 million), which was recorded as research and development expense in the Company’s consolidated statement of operations in 2019. The Company is obligated to pay Bioeq an aggregate of up to €12.5 million in additional milestone payments in connection with the achievement of certain development and regulatory milestones with respect to the Bioeq Licensed Products in the United States. The Company will share a percentage of gross profits on sales of Bioeq Licensed Products in the United States with Bioeq in the low to mid fifty percent range. The additional milestone payments and royalties are contingent upon future events and, therefore, will be recorded when it is probable that a milestone will be achieved or when royalties are due. As of December 31, 2021 and 2020, the Company did not have any outstanding obligations for milestones and royalties to Bioeq. |
Debt Obligations
Debt Obligations | 12 Months Ended |
Dec. 31, 2021 | |
Debt Obligations | |
Debt Obligations | 7. 1.5% Convertible Senior Subordinated Notes due 2026 In April 2020, the Company issued and sold $230.0 million aggregate principal amount of its 1.5% Convertible Senior Subordinated notes due 2026 (the “2026 Convertible Notes”) in a private offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act. The net proceeds from the offering were $222.2 million after deducting initial purchasers’ fees and offering expenses. The 2026 Convertible Notes are general unsecured obligations and will be subordinated to the Company’s designated senior indebtedness (as defined in the indenture for the 2026 Convertible Notes) and structurally subordinated to all existing and future indebtedness and other liabilities, including trade payables. The 2026 Convertible Notes accrue interest at a rate of 1.5% per annum, payable semi-annually in arrears on April 15 and October 15 of each year, since October 15, 2020, and will mature on April 15, 2026 , unless earlier repurchased or converted. At any time before the close of business on the second scheduled trading day immediately before the maturity date, noteholders may convert their 2026 Convertible Notes at their option into shares of the Company’s common stock, together, if applicable, with cash in lieu of any fractional share, at the then-applicable conversion rate. The initial conversion rate is 51.9224 shares of common stock per $1,000 principal amount of the 2026 Convertible Notes, which represents an initial conversion price of approximately $19.26 per share of common stock. The initial conversion price represents a premium of approximately 30.0% over the last reported sale of $14.815 per share of the Company’s common stock on the Nasdaq Global Market on April 14, 2020, the date the 2026 Convertible Notes were issued. The conversion rate and conversion price will be subject to customary adjustments upon the occurrence of certain events. If a “make-whole fundamental change” (as defined in the indenture for the 2026 Convertible Notes) occurs, the Company will, in certain circumstances, increase the conversion rate for a specified period of time for noteholders who convert their 2026 Convertible Notes in connection with that make-whole fundamental change. The 2026 Convertible Notes are not redeemable at the Company’s election before maturity. If a “fundamental change” (as defined in the indenture for the 2026 Convertible Notes) occurs, then, subject to a limited exception, noteholders may require the Company to repurchase their 2026 Convertible Notes for cash. The repurchase price will be equal to the principal amount of the 2026 Convertible Notes to be repurchased, plus accrued and unpaid interest, if any, to, but excluding, the applicable repurchase date. The 2026 Convertible Notes have customary provisions relating to the occurrence of “events of default” (as defined in the Indenture for the 2026 Convertible Notes). The occurrence of such events of default could result in the acceleration of all amounts due under the 2026 Convertible Notes. As of December 31, 2021, the Company was in full compliance with these covenants and there were no events of default under the 2026 Convertible Notes. The Company evaluated the features embedded in the 2026 Convertible Notes under the relevant accounting rules and concluded that the embedded features do not meet the requirements for bifurcation, and therefore do not need to be separately accounted for as an equity component. The proceeds received from the issuance of the convertible debt were recorded as a liability on the consolidated balance sheets. Capped Call Transactions In connection with the pricing of the 2026 Convertible Notes, the Company also paid $18.2 million to enter into privately negotiated capped call transactions with one or a combination of the initial purchasers, their respective affiliates and other financial institutions (the “option counterparties”). The capped call transactions are generally expected to reduce the potential dilution upon conversion of the 2026 Convertible Notes in the event that the market price per share of the Company’s common stock, as measured under the terms of the capped call transactions, is greater than the strike price of the capped call transactions, which initially corresponds to the conversion price of the 2026 Convertible Notes, and is subject to anti-dilution adjustments generally similar to those applicable to the conversion rate of the 2026 Convertible Notes. The cap price of the capped call transactions will initially be $25.9263 per share, which represents a premium of approximately 75.0% over the last reported sale price of the Company’s common stock of $14.815 per share on April 14, 2020, and is subject to certain adjustments under the terms of the capped call transactions. The capped call transactions are accounted for as separate transactions from the 2026 Convertible Notes and classified as equity instruments. Therefore, the total $18.2 million capped call premium paid was recorded as a reduction to additional paid-in capital on the consolidated balance sheets. The Company incurred $0.9 million of debt issuance costs relating to the issuance of the 2026 Convertible Notes, which were recorded as a reduction to the notes on the consolidated balance sheet. The debt issuance costs are being amortized and recognized as additional interest expense over the six-year contractual term of the notes using the effective interest rate method. The following table summarizes components of the 2026 Convertible Notes: December 31, (in thousands) 2021 2020 Principal amount of the 2026 Convertible Notes $ 230,000 $ 230,000 Unamortized debt discount and debt issuance costs (5,712) (6,971) Total 2026 Convertible Notes $ 224,288 $ 223,029 If the 2026 Convertible Notes were converted on December 31, 2021, the holders of the 2026 Convertible Notes would have received common shares with an aggregate value of $190.6 million based on the Company’s closing stock price of $15.96 as of December 31, 2021. The following table presents the components of interest expense related to 2026 Convertible Notes: Year Ended December 31, (in thousands) 2021 2020 Stated coupon interest $ 3,450 $ 2,434 Accretion of debt discount and debt issuance costs 1,259 873 Total interest expense $ 4,709 $ 3,307 The remaining unamortized debt discount and debt offering costs related to the Company’s 2026 Convertible Notes of $5.7 million as of December 31, 2021, will be amortized using the effective interest rate over the remaining term of the 2026 Convertible Notes of 4.3 years. The annual effective interest rate is 2.1% for the 2026 Convertible Notes. Future payments on the 2026 Convertible Notes as of December 31, 2021 are as follows: Year ending December 31, (in thousands) 2022 $ 3,450 2023 3,450 2024 3,450 2025 3,450 2026 and beyond 231,725 Total minimum payments 245,525 Less amount representing interest (15,525) 2026 Convertible Notes, principal amount 230,000 Less debt discount and debt issuance costs on 2026 Convertible Notes (5,712) Net carrying amount of 2026 Convertible Notes $ 224,288 8.2% Convertible Notes due 2022 On February 29, 2016, the Company issued and sold $100.0 million aggregate principal amount, which excludes a 9.0% premium due at maturity or redemption, of its 2022 Convertible Notes . The 2022 Convertible Notes constitute general, senior unsubordinated obligations of the Company and are guaranteed by certain subsidiaries of the Company. The 2022 Convertible Notes bear interest at a fixed coupon rate of 8.2% per annum payable quarterly in arrears on March 31, June 30, September 30 and December 31 of each year, since March 31, 2016 , and will mature on March 31, 2022 , unless earlier converted, redeemed or repurchased. The 2022 Convertible Notes also bear a premium of 9.0% of their principal amount, which is payable when the 2022 Convertible Notes mature or are repurchased or redeemed by the Company. The 2022 Convertible Notes were issued to Healthcare Royalty Partners III, L.P., for $75.0 million in aggregate principal amount, and to three related party investors, KKR Biosimilar L.P., MX II Associates LLC, and KMG Capital Partners, LLC, for $20.0 million, $4.0 million, and $1.0 million, respectively, in aggregate principal amount. At any time before the close of business on the business day immediately preceding March 31, 2022, the 2022 Convertible Note noteholders may convert their 2022 Convertible Notes at their option into shares of the Company’s common stock, together, if applicable, with cash in lieu of any fractional share, at the then-applicable conversion rate. The initial conversion rate is 44.7387 shares of common stock per $1,000 principal amount of the 2022 Convertible Notes, which represents an initial conversion price of approximately $22.35 per share of common stock. The initial conversion price represents a 60% premium over the average last reported sale price of our common stock over the 15 trading days preceding the date the 2022 Convertible Notes were issued. The conversion rate and conversion price will be subject to customary adjustments upon the occurrence of certain events. The 2022 Convertible Notes are redeemable in whole, and not in part, at the Company’s option with effect from March 31, 2020, if the last reported sale price per share of common stock exceeds 160% of the conversion price on 20 or more trading days during the 30 consecutive trading days preceding the date on which the Company sends notice of such redemption to the holders of the 2022 Convertible Notes. At maturity or redemption, if not earlier converted, the Company will pay 109% of the principal amount of the 2022 Convertible Notes maturing or being redeemed, together with accrued and unpaid interest, in cash. The 2022 Convertible Notes contain customary negative covenants and events of default, the occurrence of which could result in the acceleration of all amounts due under the 2022 Convertible Notes. The 2022 Convertible Notes also contain covenants restricting the Company’s ability to incur additional indebtedness for borrowed money or convertible preferred stock and to pay dividends or make distributions on the Company’s equity interests, subject to certain exceptions. As of December 31, 2021, the Company was in full compliance with these covenants and there were no events of default under the 2022 Convertible Notes. The Company evaluated the features embedded in the 2022 Convertible Notes under the relevant accounting rules and concluded that the embedded features do not meet the requirements for bifurcation, and therefore do not need to be separately accounted for as an equity component. The Company granted the holders of the 2022 Convertible Notes certain registration rights requiring the Company to register, under the Securities Act of 1933, as amended, the resale of the shares of common stock issuable upon conversion or settlement of the 2022 Convertible Notes. The following table summarizes components of the 2022 Convertible Notes: December 31, (in thousands) 2021 2020 Principal amount of the 2022 Convertible Notes $ 81,750 $ 81,750 Unamortized debt discount and debt issuance costs (391) (1,865) 2022 Convertible Notes $ 81,359 $ 79,885 Principal amount of the 2022 Convertible Notes - related parties $ 27,250 $ 27,250 Unamortized debt discount and debt issuance costs - related parties (130) (622) 2022 Convertible Notes - related parties $ 27,120 $ 26,628 Total 2022 Convertible Notes, net carrying amount $ 108,479 $ 106,513 In January 2022, the Company entered into the 2027 Term Loans (see Note 14. Subsequent Events). Since the Company expects to refinance the 2022 Convertible Notes with proceeds from the 2027 Term Loans which will be funded no later than April 1, 2022, subject to the delivery certain customary deliverables and which mature in 2027, the 2022 Convertible Notes were classified as non-current on the December 31, 2021 consolidated balance sheets. The contractual future payments on the 2022 Convertible Notes as of December 31, 2021, without consideration of the expected refinancing, is $111.1 million due in 2022, inclusive of $2.1 million of interest. If the 2022 Convertible Notes were converted on December 31, 2021, the holders of the 2022 Convertible Notes would receive common shares with an aggregate value of $71.4 million based on the Company’s closing stock price of $15.96. The following table presents the components of interest expense of the 2022 Convertible Notes: Year Ended December 31, (in thousands) 2021 2020 2019 Stated coupon interest $ 6,150 $ 6,150 $ 6,150 Accretion of debt discount and debt issuance costs 1,475 1,343 1,223 Interest expense $ 7,625 $ 7,493 $ 7,373 Stated coupon interest - related parties $ 2,050 $ 2,050 $ 2,050 Accretion of debt discount and debt issuance costs - related parties 491 448 407 Interest expense - related parties $ 2,541 $ 2,498 $ 2,457 Total interest expense $ 10,166 $ 9,991 $ 9,830 The remaining total unamortized debt discount and debt offering costs related to the Company’s 2022 Convertible Notes and 2022 Convertible Notes – related parties of $0.5 million as of December 31, 2021, will be amortized using the effective interest rate over the remaining term of three months from the balance sheet date. The annual effective interest rate is 9.5% for the 2022 Convertible Notes and 2022 Convertible Notes – related parties. 2025 Term Loan On January 7, 2019 (the “2025 Term Loan Closing Date”), the Company entered into a credit agreement (the “2025 Term Loan”) with affiliates of Healthcare Royalty Partners (together, the “Lender”). The 2025 Term Loan consists of a six-year term loan facility for an aggregate principal amount of $75.0 million (the “Borrowings”). The obligations of the Company under the loan documents are guaranteed by the Company’s material domestic United States subsidiaries. The Borrowings under the 2025 Term Loan bear interest through maturity at 7.00% per annum plus three month LIBOR. Pursuant to the terms of the 2025 Term Loan, the interest rate was reduced to 6.75% per annum plus LIBOR as of January 1, 2020 as the consolidated net sales for UDENYCA for the fiscal year ending December 31, 2019 were in excess of $250.0 million. Interest is payable quarterly in arrears. Under the prospective method to account for future cash payments adopted by the Company, the effective interest rate is not constant, and any change in the expected cash flows is recognized prospectively as an adjustment to the effective yield. As of December 31, 2021, the effective interest rate was 10.7%. Pursuant to the terms of the 2025 Term Loan, the Company was required to begin paying principal on the Borrowings in equal quarterly installments beginning on the third anniversary of the 2025 Term Loan Closing Date, with the outstanding balance to be repaid on January 7, 2025, the maturity date. However, in January 2022, the Company entered into the 2027 Term Loans (see Note 14. Subsequent Events) and voluntarily prepaid all amounts outstanding under the 2025 Term Loan, pursuant to which a payoff amount of $81.9 million was outstanding. Since the Company expected to refinance the 2025 Term Loan with proceeds from Tranche A of the 2027 Term Loans which was funded on January 5, 2022 and will mature in 2027, the 2025 Term Loan was classified as non-current on the December 31, 2021 consolidated balance sheets. If all or any of the Borrowings are prepaid or required to be prepaid under the 2025 Term Loan, then the Company shall pay, in addition to such prepayment, a prepayment premium equal to (i) with respect to any prepayment paid or required to be paid on or prior to the three year anniversary of the Credit Agreement Closing Date, 5.00% of the Borrowings prepaid or required to be prepaid, plus all required interest payments that would have been due on the Borrowings prepaid or required to be prepaid through and including the three year anniversary of the 2025 Term Loan Closing Date, (ii) with respect to any prepayment paid or required to be paid after the three year anniversary of the 2025 Term Loan Closing Date but on or prior to the four year anniversary of the 2025 Term Loan Closing Date, 5.00% of the Borrowings prepaid or required to be prepaid, (iii) with respect to any prepayment paid or required to be paid after the four year anniversary of the 2025 Term Loan Closing Date but on or prior to the five year anniversary of the 2025 Term Loan Closing Date, 2.50% of the Borrowings prepaid or required to be prepaid, and (iv) with respect to any prepayment paid or required to be prepaid thereafter, 1.25% of the Borrowings prepaid or required to be prepaid. In connection with the 2025 Term Loan, the Company paid a fee to the Lender of approximately $1.1 million at closing in the form of an original issue discount. Upon the prepayment or maturity of the Borrowings (or upon the date such prepayment or repayment is required to be paid), it is required to pay an additional exit fee in an amount equal to 4.00% of the total principal amount of the Borrowings. The obligations under the 2025 Term Loan are secured by a lien on substantially all of the Company’s tangible and intangible property, including intellectual property. The 2025 Term Loan contains certain affirmative covenants, negative covenants and events of default, including, covenants and restrictions that among other things, restrict the ability of the Company and its subsidiaries to, incur liens, incur additional indebtedness, make loans and investments, engage in mergers and acquisitions, in asset sales, and declare dividends or redeem or repurchase capital stock. Additionally, the consolidated net sales for UDENYCA must not be lower than $70.0 million for the fiscal year ending December 31, 2019, (b) $125.0 million for the fiscal year ending December 31, 2020, and (c) $150.0 million for each fiscal year thereafter. A failure to comply with these covenants could permit the Lender under the 2025 Term Loan to declare the Borrowings, together with accrued interest and fees, to be immediately due and payable. As of December 31, 2021, the Company was in full compliance with these covenants and there were no events of default under the 2025 Term Loan. The following table summarizes components of the 2025 Term Loan: December 31, (in thousands) 2021 2020 Principal amount of the 2025 Term Loan $ 75,000 $ 75,000 Exit fee due on payment of 2025 Term Loan 3,000 3,000 2025 Term Loan, gross 78,000 78,000 Unamortized exit fee, debt discount and debt issuance costs, net (2,487) (3,519) Net carrying amount of 2025 Term Loan $ 75,513 $ 74,481 The following table presents the components of interest expense of the 2025 Term Loan: Year Ended December 31, (in thousands) 2021 2020 2019 Stated coupon interest $ 7,034 $ 7,053 $ 7,063 Accretion of debt discount and debt issuance costs 1,032 818 709 Interest expense $ 8,066 $ 7,871 $ 7,772 In January 2022 , the 2025 Term Loan was refinanced with proceeds from the 2027 Term Loans which mature in 2027 Year ending December 31, (in thousands) 2022 $ 29,294 2023 27,130 2024 24,972 2025 8,780 Total minimum payments 90,176 Less amount representing interest (12,176) 2025 Term Loan, gross 78,000 Less unamortized exit fee, debt discount and debt issuance costs, net (2,487) Net carrying amount of 2025 Term Loan $ 75,513 8. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies. | |
Commitments and Contingencies | 8. Commitments and Contingencies Purchase Commitments The Company entered into agreements with certain vendors to secure raw materials and certain CMOs to manufacture its supply of products. As of December 31, 2021, the Company’s non-cancelable contractual obligations under the terms of its agreements are as follows: Years ending December 31, (in thousands) 2022 $ 27,052 2023 16,300 2024 10,108 2025 268 2026 179 Total obligations $ 53,907 The Company enters into contracts in the normal course of business with contract research organizations for preclinical studies and clinical trials and CMOs for the manufacture of clinical trial materials. The contracts are cancellable, with varying provisions regarding termination. If a contract with a specific vendor were to be terminated, the Company would generally only be obligated for products or services that the Company had received as of the effective date of the termination and any applicable cancellation fees. Guarantees and Indemnifications In the normal course of business, the Company enters into contracts and agreements that contain a variety of representations and warranties and provide for general indemnifications. The Company’s exposure under these agreements is unknown because it involves claims that may be made against the Company in the future, but have not yet been made. To date, the Company has not paid any claims or been required to defend any action related to its indemnification obligations. However, the Company may record charges in the future as a result of these indemnification obligations. The Company would assess the likelihood of any adverse judgments or related claims, as well as ranges of probable losses. In the cases where the Company believes that a reasonably possible or probable loss exists, it will disclose the facts and circumstances of the claims, including an estimate range, if possible. Legal Proceedings The Company is a party to various legal proceedings and claims that arise in the ordinary, routine course of business and that have not been fully resolved. The outcome of such legal proceedings and claims is inherently uncertain. Accruals are recognized for such legal proceedings and claims to the extent that a loss is both probable and reasonably estimable. The best estimate of a loss within a range is accrued; however, if no estimate in the range is better than any other, then the minimum amount in the range is accrued. If its determined that a material loss is reasonably possible and the loss or range of loss can be estimated, the possible loss is disclosed. Sometimes it is not possible to determine the outcome of these matters or, unless otherwise noted, the outcome (including in excess of any accrual) is not expected to be material, and the maximum potential exposure or the range of possible loss cannot be reasonably estimated. The Company did not have any material accruals in the consolidated balance sheets as of December 31, 2021 and 2020. There are no material pending legal proceedings, other than ordinary routine litigation incidental to the business, to which the Company or any of its subsidiaries is a party, or that any of the Company or its subsidiaries' property is subject. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2021 | |
Leases | |
Leases | 9. The Company leases approximately 47,789 square feet of office space for its corporate headquarters in Redwood City, California. This lease terminates in September 2024 one May 2027 one The Company determined that the above facility leases were operating leases. The options to extend the lease terms for these leases were not included as part of the right-of-use asset or lease liability as it was not reasonably certain the Company would exercise those options. In 2019, the Company entered into a vehicle lease agreement, pursuant to which the Company currently leases approximately 50 vehicles. Delivery of the vehicles commenced during the first quarter of 2020. The term of each leased vehicle is 36 months and commences upon the delivery of the vehicle. The vehicles leased under this arrangement were classified as finance leases. For the leases that commenced prior to January 1, 2019 (adoption date of ASC 842), the Company determined the present value of the lease payments using the incremental borrowing rate on that date. For all other leases, the Company used the incremental borrowing rate on the lease commencement or the lease modification date, as applicable. Supplemental information related to the Company’s leases is as follows: (in thousands) December 31, Assets Balance Sheet Classification 2021 2020 Operating lease Other assets, non-current $ 8,193 $ 9,956 Finance lease Property and equipment, net 1,220 1,451 Total leased assets $ 9,413 $ 11,407 (in thousands) December 31, Liabilities Balance Sheet Classification 2021 2020 Operating lease liabilities, current Accrued and other current liabilities $ 2,751 $ 2,573 Operating lease liabilities, non-current Lease liabilities, non-current 6,753 9,073 Total operating lease liabilities $ 9,504 $ 11,646 Finance lease liabilities, current Accrued and other current liabilities $ 741 $ 560 Finance lease liabilities, non-current Lease liabilities, non-current 498 875 Total finance lease liabilities $ 1,239 $ 1,435 Operating lease costs were $3.1 million, $3.1 million and $2.4 million in 2021, 2020 and 2019, respectively. Cash paid for amounts included in the measurement of the operating lease liabilities in 2021 and 2020 was $3.4 million and $3.2 million, respectively, and was included in net cash used in operating activities in the consolidated statements of cash flows. Finance lease costs and cash paid for amounts included in the measurement of finance lease liabilities were immaterial during 2021, 2020 and 2019. As of December 31, 2021, the maturities of the lease liabilities were as follows: Years ending December 31, (in thousands) Operating leases Finance leases 2022 $ 3,401 $ 790 2023 3,560 449 2024 3,014 61 2025 412 — 2026 and thereafter 416 — Total lease payments 10,803 1,300 Less imputed interest (1,299) (61) Lease liabilities $ 9,504 $ 1,239 As of December 31, 2021 and 2020, the weighted average remaining lease term for operating leases was 3.2 years and 4.1 years, respectively. The weighted average discount rate used to determine the operating lease liabilities was 8.0% and 8.1% as of December 31, 2021 and 2020, respectively. The weighted average remaining lease term for finance leases was 1.7 years and 2.4 years as of December 31, 2021 and 2020, respectively. The weighted average discount rate used to determine the finance lease liabilities was 5.8% as of December 31, 2021 and 2020, respectively. |
Stock-Based Compensation and Em
Stock-Based Compensation and Employee Benefits | 12 Months Ended |
Dec. 31, 2021 | |
Stock-Based Compensation | |
Stock-Based Compensation | 10. Equity Incentive Plans In October 2014, the Company’s board of directors and its stockholders adopted the 2014 Equity Incentive Plan, which became effective upon the closing of the Company’s IPO on November 6, 2014. The 2014 Plan is subject to automatic annual increases in the number of shares available for issuance on the first business day of each fiscal year equal to four percent (4%) of the number of shares of the Company’s common stock outstanding as of such date or a lesser number of shares as determined by the Company’s board of directors. All remaining shares under the Company’s 2010 Stock Plan (the “2010 Plan”) were transferred to the 2014 Plan upon adoption and any additional shares that would otherwise return to the 2010 Plan as a result of forfeiture, termination or expiration of the awards will return to the 2014 Plan. The 2014 Plan provided for the Company to grant shares and/or options to purchase shares of common stock to employees, directors, consultants and other service providers. While the 2014 Plan allows for non-qualified or incentive stock options, all option grants made since June 2016 have been for non-qualified stock options. Under the 2010 Plan, no awards have been issued since 2014, and there were no shares of common stock available for future issuance as of December 31, 2021. There were 468,671 shares of common stock available for future issuance as of December 31, 2021 under the 2014 Plan. In June 2016, the Company adopted the 2016 Employment Commencement Incentive Plan. The 2016 Plan is designed to comply with the inducement exemption contained in Nasdaq’s Rule 5635(c)(4), which provides for the grant of non-qualified stock options, restricted stock units, restricted stock awards, performance awards, dividend equivalents, deferred stock awards, deferred stock units, stock payment and stock appreciation rights to a person not previously an employee or director of the Company, or following a bona fide period of non-employment, as an inducement material to the individual’s entering into employment with the Company. As of December 31, 2021, the Company had 446,037 shares of common stock available for future issuance for new employees. The 2016 Plan does not provide for any annual increases in the number of shares available. Stock option exercises are settled with common stock from the plans’ previously authorized and available pool of shares. If any shares subject to an award granted under the 2014 Plan or the 2016 Plan expire or become forfeited, terminated or canceled without the issuance of shares, the shares subject to such awards are added back into the authorized pool on the same basis that they were removed. In addition, shares withheld to pay for minimum statutory tax obligations with respect to full-value awards are added back into the authorized pool. The annual grant to eligible employees can vary on the type of award, and the award size is determined by the employee’s grade level. Stock Options Incentive stock options and non-statutory stock options may be granted with exercise prices of not less than the fair value of the common stock on the date of grant. These stock options generally vest over four years, expire in ten years from the date of grant and are generally exercisable after vesting. The following table sets forth the summary of option activities under the 2016 Plan and the 2014 Plan: Options Outstanding Weighted- Number of Average Options Exercise Price Balances at December 31, 2020 19,014,835 $ 15.41 Granted - at fair value 4,559,125 $ 16.62 Exercised (1,316,361) $ 7.91 Forfeited/Canceled (2,297,784) $ 17.96 Balances at December 31, 2021 19,959,815 $ 15.89 Additional information related to the status of options as of December 31, 2021 is summarized as follows: Weighted- Weighted- Average Aggregate Average Remaining Intrinsic Number of Exercise Contractual Terms Value (in Options Price (Years) thousands) Options outstanding 19,959,815 $ 15.89 6.4 $ 47,892 Options vested and exercisable 13,453,683 $ 15.56 5.4 $ 43,291 During the years ended December 31, 2021, 2020 and 2019, the estimated weighted-average grant-date fair value of options granted was $9.80, $10.94 and $9.52 per share, respectively, and the aggregate intrinsic value of options exercised was $9.7 million, $14.6 million and $10.3 million, respectively. The intrinsic value is defined as the difference between the current market value and the exercise price. The Company recognized stock-based compensation expense of $36.7 million, $30.3 million and $31.4 million in 2021, 2020 and 2019, respectively, related to stock options. As of December 31, 2021, total unrecognized stock-based compensation expenses related to unvested stock options was $61.4 million, which is expected to be recognized on a straight-line basis over a weighted-average period of 2.6 years. Restricted Stock Units The Company grants restricted stock units (“RSUs”) primarily to its employees. RSUs are share awards that entitle the holder to receive freely tradable shares of our common stock upon vesting. The RSUs cannot be transferred and are subject to forfeiture if the holder’s employment terminates prior to the release of the vesting restrictions. The Company’s RSUs generally vest over one The following table sets forth the summary of RSUs activity, under the 2014 Plan: RSUs Outstanding Weighted-Average Number of Grant Date Fair RSUs Value Balances at December 31, 2020 1,009,657 $ 17.91 RSUs granted 1,652,512 $ 16.86 RSUs vested (465,930) $ 18.10 RSUs canceled (352,507) $ 17.54 Balances at December 31, 2021 1,843,732 $ 17.00 The total fair value of RSUs vested was $8.4 million, $4.1 million and $2.7 million during the years ended December 31, 2021, 2020 and 2019, respectively. The total estimated grant date fair value of RSUs was $27.9 million, $21.2 million and $4.3 million granted during the years ended December 31, 2021, 2020 and 2019, respectively. The estimated weighted-average grant-date fair value per share of RSUs granted during the years ended December 31, 2021, 2020 and 2019 was $16.86, $17.86 and $15.11, respectively. The Company recognized stock-based compensation expense related to RSUs of $13.5 million, $6.5 million and $0.8 million in 2021, 2020 and 2019, respectively. As of December 31, 2021, total unrecognized stock-based compensation expenses related to unvested RSUs was $20.7 million, which is expected to be recognized on a straight-line basis over a weighted-average period of 1.8 years. Employee Stock Purchase Plan In October 2014, the Company’s board of directors and its stockholders approved the establishment of the ESPP. The ESPP provides for annual increases in the number of shares available for issuance on the first business day of each fiscal year equal to the lesser of one percent (1%) of the number of shares of the Company’s common stock outstanding as of such date or a number of shares as determined by the Company’s board of directors. The ESPP had 3,238,648 shares of common stock available for future issuance as of December 31, 2021. Eligible employees may purchase common stock at 85% of the lesser of the fair market value of the Company’s common stock on the first or last day of the offering period. The offering periods of the ESPP are on May 16 November 16 Stock-Based Compensation Stock-based compensation expense is reflected in the consolidated statements of operations as follows: Year Ended December 31, (in thousands) 2021 2020 2019 Cost of goods sold (1) $ 1,099 $ 583 $ 108 Research and development 18,688 13,837 12,912 Selling, general and administrative 31,577 23,740 20,571 Stock-based compensation expense $ 51,364 $ 38,160 $ 33,591 Capitalized stock-based compensation expense into inventory $ 1,025 $ 1,460 $ 1,735 (1) Stock-based compensation capitalized into inventory is recognized as cost of sales when the related product is sold. Valuation Assumptions of Awards Granted to Employees The Company estimated the fair value of each stock option and awards granted under the ESPP on the date of grant using the Black-Scholes option-pricing model. The following table illustrates the weighted average assumptions for the Black-Scholes option-pricing model used in determining the fair value of the awards during the years ended December 31, 2021, 2020 and 2019: Year Ended December 31, 2021 2020 2019 Expected term (years) Stock options 6.08 6.10 6.00 ESPP 0.50 0.50 0.50 Expected volatility Stock options 65 % 68 % 69 % ESPP 42 % 58 % 61 % Risk-free interest rate Stock options 0.89 % 1.09 % 2.29 % ESPP 0.06 % 0.13 % 1.89 % Expected dividend yield Stock options — % — % — % ESPP — % — % — % Expected Term: Expected Volatility: Risk-Free Interest Rate: Expected Dividends: 401(k) Retirement Plan In 2019, the Company’s Compensation Committee approved the Company’s matching of the employees 401(k) Plan (the “401(k) Plan”) whereby eligible employees may elect to contribute up to the lesser of 90% of their annual compensation or the statutorily prescribed annual limit allowable under Internal Revenue Service regulations. Beginning January 1, 2021, the Company made matching contributions of 100% of the first 4% of eligible compensation, up to a maximum of $7,500. In 2020 and 2019, the Company made matching contributions of 50% of the first $6,000 of each participant’s contributions. The Company recorded compensation expense related to the match of $1.7 million, $0.8 million and $0.8 million in 2021, 2020 and 2019, respectively. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2021 | |
Income Taxes | |
Income Taxes | 11. The components of (loss) income before income taxes are as follows: Year Ended December 31, (in thousands) 2021 2020 2019 Domestic $ (287,058) $ 133,615 $ 92,585 Foreign (42) 2,092 190 Total $ (287,100) $ 135,707 $ 92,775 Provision for income taxes: Year Ended December 31, (in thousands) 2021 2020 2019 Current: Federal $ — $ — $ — State — 3,463 2,942 Foreign — — — Subtotal $ — $ 3,463 $ 2,942 Deferred: Federal $ — $ — $ — State — — — Foreign — — — Subtotal $ — $ — $ — Provision for income taxes $ — $ 3,463 $ 2,942 There was no income tax provision in 2021 due to the Company’s history of losses and valuation of allowances against the deferred tax assets. The income tax provisions in 2020 and 2019 of $3.5 million and $2.9 million, respectively, primarily relate to state taxes in jurisdictions outside of California, for which the Company has a limited operating history. A reconciliation of the statutory United States federal rate to the Company’s effective tax rate is as follows: Year Ended December 31, 2021 2020 2019 Percent of pre-tax income: United States federal statutory income tax rate 21.0 % 21.0 % 21.0 % State taxes, net of federal benefit 2.6 2.0 1.5 Foreign rate differences (0.0) (0.3) (0.1) Permanent items 0.2 0.4 (0.6) Research and development credit 2.6 (4.8) (4.8) Stock based compensation costs (1.2) 1.3 1.3 Other (0.0) (0.3) (0.7) Change in valuation allowance (25.2) (16.7) (14.4) Effective income tax rate (0.0) % 2.6 % 3.2 % The components of the Company’s net deferred tax assets as of December 31, 2021 and 2020 consist of the following: December 31, (in thousands) 2021 2020 Net operating loss carryforwards $ 117,793 $ 94,043 Research and development credits 58,039 49,965 Depreciation and amortization 40,620 9,672 Stock-based compensation 30,565 25,983 Sales related accruals 17,299 16,404 Other accruals 11,798 8,013 Gross deferred tax assets 276,114 204,080 Right-of-use asset (2,167) (2,566) In-process research and development (603) (589) Gross deferred tax liabilities (2,770) (3,155) Total net deferred tax asset 273,344 200,925 Less valuation allowance (273,344) (200,925) Net deferred tax assets $ — $ — The tax benefit of net operating losses, temporary differences and credit carry forwards is recorded as an asset to the extent that management assesses that realization is “more likely than not.” The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which the temporary differences representing net future deductible amounts become deductible. Due to the Company’s history of losses, and lack of other positive evidence, the Company has determined that it is more likely than not that its Federal net deferred tax assets and certain state net deferred tax assets will not be realized, and therefore, the Company has fully offset the Federal and certain state net deferred tax assets by a valuation allowance as of December 31, 2021 and 2020. The valuation allowance increased by $72.4 million during the year ended December 31, 2021 and decreased by $22.7 million and $13.4 million during the years ended December 31, 2020 and 2019, respectively. As of December 31, 2021, the Company had operating loss carryforwards for federal income of $533.5 million, which will start to expire in the year 2036, and various states net operating loss carryforwards of $83.7 million, which have various expiration dates beginning in 2031. As of December 31, 2021, the Company had federal research and development credit carryforwards for federal income tax purposes of $54.0 million, which will start to expire in the year 2031, and state research and development credit carryforwards of $23.5 million, which have no expiration date. Utilization of the net operating loss and tax credit carryforwards may be subject to an annual limitation due to historical or future ownership percentage change rules provided by the Internal Revenue Code of 1986, as amended, and similar state provisions. The annual limitation may result in the expiration of certain net operating loss and tax credit carryforwards before their utilization. Under the new enacted tax law, the carry forward period of net operating losses generated from 2018 forward is indefinite. However, the carryforward period for net operating losses generated prior to 2018 remains the same. Therefore, the annual limitation may result in the expiration of certain net operating losses and tax credit carryforwards before their utilization. The Company files United States, California and other state income tax returns with varying statutes of limitations. The tax years from 2011 forward remain open to examination due to the carryover of unused net operating losses and tax credits. A reconciliation of the Company’s unrecognized tax benefits during 2021, 2020 and 2019 is as follows: Year Ended December 31, (in thousands) 2021 2020 2019 Balance at beginning of year $ 13,243 $ 11,603 $ 18,115 Additions based on tax positions related to current year 2,038 1,749 1,206 Additions (reductions) for tax positions of prior years 214 (109) (7,718) Balance at end of year $ 15,495 $ 13,243 $ 11,603 As of December 31, 2021, 2020 and 2019, the Company had $15.5 million, $13.2 million and $11.6 million, respectively, of unrecognized benefits, none of which would currently affect the Company’s effective tax rate if recognized due to the Company’s deferred tax assets being fully offset by a valuation allowance. During 2021, 2020 and 2019, the Company did not recognize accrued interest and penalties related to unrecognized tax benefits. The Company does not anticipate a material adjustment of unrecognized tax benefits during the next twelve months from the balance sheet date as reductions for tax positions of prior years. The Company files United States, state and foreign income tax returns with varying statutes of limitations. The tax years from inception in 2011 forward remain open to examination due to the carryover of unused net operating losses and tax credits. |
Net (Loss) Income Per Share
Net (Loss) Income Per Share | 12 Months Ended |
Dec. 31, 2021 | |
Net (Loss) Income Per Share | |
Net (Loss) Income Per Share | 12. The following table sets forth the computation of the basic and diluted net (loss) income per share: Years Ended December 31, (in thousands, except share and per share data) 2021 2020 2019 Basic net (loss) income per share Numerator: Net (loss) income $ (287,100) $ 132,244 $ 89,833 Denominator: Weighted-average common shares outstanding 75,449,632 71,411,705 69,679,916 Basic net (loss) income per share $ (3.81) $ 1.85 $ 1.29 Diluted net (loss) income per share Numerator: Net (loss) income $ (287,100) $ 132,244 $ 89,833 Add interest expense on 2026 Convertible Notes, net of tax — 3,307 — Numerator for diluted net (loss) income per share (287,100) 135,551 89,833 Denominator: Denominator for basic net (loss) income per share 75,449,632 71,411,705 69,679,916 Add effect of potential dilutive securities: Stock options, including shares subject to ESPP — 3,455,646 3,491,272 Restricted stock units — 167,597 14,755 Shares issuable upon conversion of convertible notes — 8,456,950 — Denominator for diluted net (loss) income per share 75,449,632 83,491,898 73,185,943 Diluted net (loss) income per share $ (3.81) $ 1.62 $ 1.23 The following outstanding dilutive potential shares were excluded from the calculation of diluted net (loss) income per share due to their anti-dilutive effect: The following outstanding dilutive potential shares were excluded from the calculation of diluted net (loss) income per share due to their anti-dilutive effect:he following outstanding dilutive potential shares were excluded from the calculation of diluted net (loss) income per share due to their anti-dilutive effect: Year Ended December 31, 2021 2020 2019 Stock options, including shares subject to ESPP 19,895,097 9,521,403 10,412,471 Restricted stock units 1,811,607 7,689 22,068 Shares issuable upon conversion of 2022 Convertible Notes 4,473,871 4,473,871 4,473,871 Shares issuable upon conversion of 2026 Convertible Notes 11,942,152 — — Total 38,122,727 14,002,963 14,908,410 |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2021 | |
Related Party Transactions | |
Related Party Transactions | 13. Related Party Transactions Convertible Notes — Related Parties In February 2016, the Company issued the 2022 Convertible Notes to certain related parties (certain companies affiliated with members of the Company’s board of directors), for an aggregate principal amount of $25.0 million (see Note 7. Debt Obligations). Consulting services In October 2020, the Company entered into a consulting agreement with Lanfear Advisors owned by Mr. Jonathan Lanfear who is the brother of Dennis Lanfear, the Company’s President, Chief Executive Officer and Chairman of the Board of Directors. Mr. Jonathan Lanfear provided consulting services with respect to the Collaboration Agreement executed with Junshi Biosciences in February 2021 and the Letter Agreement with Junshi Biosciences related to the Collaboration Agreement dated January 9, 2022 (See Note 6. Collaborations and Other Arrangements). In addition to the hourly consulting fee paid to Lanfear Advisors under the consulting agreement, the Company granted fully vested stock options to purchase 65,000 shares of common stock with an exercise price of $17.60 per share to Mr. Jonathan Lanfear in February 2021 upon the execution of the Collaboration Agreement with Junshi Biosciences and recognized stock-based compensation expense of $0.8 million. The Company recorded cash consulting expense of $0.2 million and $0.3 million in 2021 and 2020, respectively, with respect to these consulting services. Total liabilities recognized in accounts payable and accrued and other current liabilities on the consolidated balance sheets with respect to these services were $0.0 million and $0.3 million as of December 31, 2021 and 2020, respectively. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2021 | |
Subsequent Events | |
Subsequent Events | 14. Subsequent Events 2027 Term Loans In January 2022, the Company entered into the Loan Agreement with the Collateral Agent and the Lenders that provides for a senior secured term loan facility of up to $400.0 million (inclusive of a $100.0 million uncommitted additional facility amount) to be funded in four committed tranches: (i) a Tranche A Loan in an aggregate principal amount of $100.0 million that was funded on January 5, 2022; (ii) a Tranche B Loan in an aggregate principal amount of $100.0 million to be funded no later than April 1, 2022, subject to the delivery of evidence of repayment, repurchase or redemption of indebtedness outstanding under our 8.2% Convertible Notes due 2022 and certain customary deliverables; (iii) a Tranche C Loan in an aggregate principal amount of $50.0 million to be funded at our option between April 1, 2022 and March 17, 2023, subject to certain conditions including the first FDA approval of a BLA for our product candidate toripalimab in the United States; and (iv) a Tranche D Loan in an aggregate principal amount of $50.0 million to be funded at our option between April 1, 2022 and March 17, 2023, subject to certain conditions including the first FDA approval of a BLA for our product candidate CHS-201 (ranibizumab biosimilar) in the United States. The Company has the right to request an uncommitted additional facility amount of up to $100.0 million after the Tranche A Closing Date that will be subject to new terms and conditions. The 2027 Term Loans mature on either (i) the fifth anniversary of the Tranche A Closing Date; or (ii) October 15, 2025, if the outstanding aggregate principal amount of our 2026 Convertible Notes is greater than $50.0 million on October 1, 2025. The 2027 Term Loans bear interest at 8.25% plus three-month LIBOR per annum with a LIBOR floor of 1.00%. In the event of the cessation of LIBOR, the benchmark governing the interest rate will be replaced with a rate based on the secured overnight financing rate published by the Federal Reserve Bank of New York as described in the Loan Agreement. Interest is payable quarterly in arrears. Repayment of outstanding principal of the 2027 Term Loans will be made in five equal quarterly payments of principal commencing after January 5, 2026. In January 2022, the Company paid to the Lenders a funding fee equal to 2.00% of the Lenders’ total committed amount to fund the Tranche A Loan, Tranche B Loan, Tranche C Loan and Tranche D Loan, payable on the Tranche A Closing Date. In addition, in the event any of the 2027 Term Loans is prepaid in whole or in part prior to the Maturity Date or is accelerated, it will be subject to a prepayment fee. Prior to the third anniversary of the Tranche A Closing Date, the prepayment fee is 3.00% of the principal amount prepaid. After the third anniversary but prior to the fourth anniversary of the Tranche A Closing Date, the prepayment fee is 2.00% of the principal amount prepaid; thereafter and prior to the Maturity Date, the prepayment fee is 1.00% of the principal amount prepaid. In addition to the prepayment fees, in connection with a full or partial prepayment of a tranche prior to the second anniversary of the applicable funding, a “make-whole” amount will be payable equal to the foregone interest from the date of prepayment through the second anniversary of the Tranche A Closing Date. The obligations under the Loan Agreement are secured pursuant to customary security documentation, including a guaranty and security agreement among the Credit Parties and the Collateral Agent which provides for a lien on substantially all of the Company’s tangible and intangible assets and property, including intellectual property. Pursuant to the Loan Agreement, and subject to certain restrictions, proceeds of the 2027 Term Loans were and will be used to fund our general corporate and working capital requirements except for the following: in January 2022, proceeds of the Tranche A Loan were used to repay in full all amounts outstanding under the 2025 Term Loan, as well as all associated costs and expenses pursuant to which a payoff amount of $81.9 million was outstanding; and proceeds of the Tranche B Loan will be used at our option to repay, repurchase or redeem in cash, in full, our existing 8.2% Convertible Notes due 2022 as well as all associated costs and expenses. The Loan Agreement contains certain customary representations and warranties. In addition, the Loan Agreement includes affirmative covenants, such as the requirement to maintain minimum trailing twelve month net sales in an amount that begins at $200 million in the current quarter and increases to $210 million for the quarter ended March 30, 2024 and increases to be as much as $300 million for the quarter ended December 31, 2024. Further, the Loan Agreement includes certain other affirmative covenants and negative covenants, including, covenants and restrictions that among other things, restrict our ability to, incur liens, incur additional indebtedness, make investments, engage in certain mergers and acquisitions or asset sales, and declare dividends or redeem or repurchase capital stock. The Loan Agreement also contains customary events of default, including among other things, our failure to make any principal or interest payments when due, the occurrence of certain bankruptcy or insolvency events or our breach of the covenants under the Loan Agreement. Upon the occurrence of an event of default, the Lenders may, among other things, accelerate our obligations under the Loan Agreement. A change of control of Coherus triggers a mandatory prepayment of the 2027 Term Loans within ten Junshi Biosciences – TIGIT Option Exercises On January 9, 2022, the Company entered into a Letter Agreement with Junshi Biosciences related to the Collaboration Agreement (the “TIGIT Exercise Letter Agreement”). Under the TIGIT Exercise Letter Agreement, the Company notified Junshi Biosciences of its election to exercise the license option for the TIGIT program described in the Collaboration Agreement (the “TIGIT Program”), with the TIGIT Exercise Letter Agreement effective on the date that all applicable waiting periods and approvals required under antitrust laws with respect to such exercise by the Company of the license option for the TIGIT Program have expired or have been terminated (in the case of waiting periods) or been received (in the case of approvals), in each case, without the imposition of any conditions (the “TIGIT Exercise Letter Agreement Effective Date”). The Company will pay the option exercise payment of $35.0 million to Junshi Biosciences no later than 10 days following the TIGIT Exercise Letter Agreement Effective Date and, if applicable, will pay up to $255 million in development regulatory and sales milestones and an 18% royalty on net product revenue as set forth under the Collaboration Agreement. Pursuant to the TIGIT Exercise Letter Agreement, Coherus will lead further development of the TIGIT antibodies included in the TIGIT Program, including JS006, in the United States and Canada, after the date it makes the option exercise payment and will be responsible for the associated development costs as set forth in the Collaboration Agreement. In January 2022, the Company initiated the process for the exercise of our option to license JS006, a TIGIT-targeted antibody, in the United States and Canada from Junshi Biosciences, . Antibodies blocking TIGIT (T cell immunoglobulin and ITIM domain) have shown potential for synergistic anti-tumor activity in combination with PD-1/PD-L1 inhibitors. In pre-clinical studies, JS006 has demonstrated strong binding affinity and inhibition of the TIGIT pathway. IND applications allowing clinical development of JS006 have been approved in China and in the United States. A dose escalation, dose expansion clinical trial (NCT05061628) evaluating the safety, tolerability and pharmacokinetic properties of JS006 as monotherapy and in combination with PD-1 inhibitor toripalimab in patients with advanced solid tumors is ongoing in China. |
Organization and Summary of S_2
Organization and Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
Organization and Summary of Significant Accounting Policies | |
Basis of Presentation | Basis of Consolidation The accompanying consolidated financial statements have been prepared in accordance with U.S. GAAP and include the accounts of Coherus and its wholly-owned subsidiaries. The Company does not have any significant interests in variable interest entities. All material intercompany transactions and balances have been eliminated upon consolidation. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make judgements, estimates and assumptions that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosures. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances. These estimates form the basis for making judgments about the carrying values of assets and liabilities when these values are not readily apparent from other sources. Estimates are assessed each period and updated to reflect current information, such as the economic considerations related to the impact that the recent COVID-19 outbreak could have on the Company’s significant accounting estimates. Accounting estimates and judgements are inherently uncertain and the actual results could differ from these estimates. |
Cash, Cash Equivalents and Restricted Cash | Cash, Cash Equivalents and Restricted Cash Cash, cash equivalents and restricted cash comprise cash and highly liquid investments with original maturities of 90 days or less. The following table provides a reconciliation of cash, cash equivalents and restricted cash within the consolidated balance sheets and which, in aggregate, represent the amount reported in the consolidated statements of cash flows: Year Ended December 31, (in thousands) 2021 2020 2019 At beginning of period: Cash and cash equivalents $ 541,158 $ 177,668 $ 72,356 Restricted cash 440 240 835 Total cash, cash equivalents and restricted cash $ 541,598 $ 177,908 $ 73,191 At end of period: Cash and cash equivalents $ 417,195 $ 541,158 $ 177,668 Restricted cash 440 440 240 Total cash, cash equivalents and restricted cash $ 417,635 $ 541,598 $ 177,908 Restricted cash consists of deposits for letters of credit that the Company has provided to secure its obligations under certain leases and is included in other assets, non-current on the consolidated balance sheets. The Company classifies the up-front and milestone payments related to licensing arrangements as cash flows from investing activities in its consolidated statements of cash flows. |
Investments in Marketable Securities | Investments in Marketable Securities Investments in marketable securities primarily consist of corporate debt obligations and commercial paper. Management determines the appropriate classification of investments in marketable securities at the time of purchase based upon management’s intent with regards to such investment and reevaluates such designation as of each balance sheet date. The Company’s investment policy requires that it only invests in highly rated securities and limit its exposure to any single issuer. All investments in marketable debt securities are held as available-for-sale and are carried at the estimated fair value as determined based upon quoted market prices or pricing models for similar securities. The Company classifies investments in marketable securities as short-term when they have remaining contractual maturities of one year or less from the balance sheet date. The Company periodically assesses its marketable securities for impairment and credit losses. Unrealized gains and losses on available-for-sale securities are reported as a component of accumulated comprehensive income (loss), with the exception of unrealized losses believed to be related to credit losses, if any, which are recognized in earnings in the period the impairment occurs. Impairment assessments are made at the individual security level each reporting period. When the fair value of an investment is less than its cost at the balance sheet date, a determination is made as to whether the impairment is related to a credit loss and, if it is, the portion of the impairment relating to credit loss is recorded as an allowance through net income. Realized gains and losses and declines in value, if any, on available-for-sale securities are included in other (expense) income, net, based on the specific identification method. During 2021, 2020 and 2019, interest income from marketable securities was $1.4 million, $0.6 million and $1.6 million, respectively. |
Trade Receivables | Trade Receivables Trade receivables are recorded net of allowances for chargebacks, chargeback prepayments, cash discounts for prompt payment and credit losses. The Company estimates an allowance for expected credit losses 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. The corresponding expense for the credit loss allowance is reflected in selling, general and administrative expenses. The credit loss allowance was immaterial as of December 31, 2021 and 2020. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes In October 2020, the FASB issued ASU 2020-10, Codification Improvements The Company has reviewed other recent accounting pronouncements and concluded they are either not applicable to the business or that no material effect is expected on the consolidated financial statements as a result of future adoption. |
Segment Reporting and Revenue by Geographic Region | Segment Reporting and Revenue by Geographic Region The Company operates and manages its business as one reportable and operating segment, which is the business of developing and commercializing human pharmaceutical products. The Company’s chief executive officer, who is the chief operating decision maker, reviews financial information on an aggregate basis for purposes of allocating resources and evaluating financial performance. All revenue is generated and all long-lived assets are primarily maintained in the United States. |
Concentration of Credit Risk | Concentrations of Risk The Company’s financial instruments that are exposed to concentration of credit risk consist primarily of cash, cash equivalents, investments and accounts receivable. The Company attempts to minimize the risks related to cash, cash equivalents and investments by investing in a broad and diverse range of financial instruments. The investment portfolio is maintained in accordance with the Company’s investment policy, which defines allowable investments, specifies credit quality standards and limits the credit exposure of any single issuer. There were no material losses from credit risks on such accounts during any of the periods presented. The Company is not exposed to any significant concentrations of credit risk from these financial instruments. The Company is subject to credit risk from trade receivables related to product sales and monitors the credit worthiness of customers that are granted credit in the normal course of business. In general, there is no requirement for collateral from customers. The Company has not experienced significant losses with respect to the collection of trade receivables. The Company believes that its allowance for expected credit losses was adequate at December 31, 2021. The Company entered into a strategic commercial supply agreement with KBI Biopharma for the supply of UDENYCA. The Company currently has not engaged back-up suppliers or vendors for this single-sourced service. If KBI Biopharma is not able to manufacture the supply needed in the quantities and timeframe required, the Company may not be able to supply the product in a timely manner. Substantially all of the Company’s revenues are in the United States to three wholesalers. UDENYCA is currently the only product sold by the Company and accounted for all of the Company’s revenues in 2021, 2020 and 2019. The Company has no significant monetary assets or liabilities in foreign currencies, and the Company has not had material foreign currency impacts for all years presented. |
Inventory | Inventory Inventory is stated at the lower of cost or estimated net realizable value with cost determined under the first-in first-out method. Inventory costs include third-party contract manufacturing, third-party packaging services, freight, labor costs for personnel involved in the manufacturing process, and indirect overhead costs. The Company primarily uses actual costs to determine the cost basis for inventory. The determination of excess or obsolete inventory requires judgment including consideration of many factors, such as estimates of future product demand, current and future market conditions, product expiration information, and potential product obsolescence, among others. Although the Company believes the assumptions used in estimating potential inventory write-downs are reasonable, if actual market conditions are less favorable than projected by management, write-downs of inventory, charges related to firm purchase commitments, or both may be required which would be recorded as cost of goods sold in the consolidated statement of operations. Adverse developments affecting the Company’s assumptions of the level and timing of demand for its products include those that are outside of the Company’s control such as the actions taken by competitors and customers, the direct or indirect effects of the COVID-19 pandemic, and other factors. Prior to the regulatory approval of our product candidates, the Company incurred expenses for the manufacture of drug product that could potentially be available to support the commercial launch of our products. I nventory costs are capitalized when future commercialization is considered probable and the future economic benefit is expected to be realized, based on management’s judgment. A number of factors are considered, including the current status in the regulatory approval process, potential impediments to the approval process such as safety or efficacy, viability of commercialization and marketplace trends. All inventory on the consolidated balance sheet as of December 31, 2021 was related to UDENYCA. |
Property and Equipment | Property and Equipment Property and equipment is stated at cost less accumulated depreciation and amortization. Maintenance and repairs are charged to expense as incurred. Interest costs incurred during the construction of major capital projects are capitalized until the underlying asset is ready for its intended use, at which point the capitalized interest costs are amortized as depreciation or amortization expense over the life of the underlying asset. When the Company disposes of property and equipment, it removes the associated cost and accumulated depreciation from the related accounts in the consolidated balance sheets and include any resulting gain or loss in the consolidated statements of operations. Eligible costs of internal use software and implementation costs of certain hosting arrangements are capitalized and amortized over the estimated useful life of the software or associated hosting arrangement, as applicable. Depreciation and amortization are recognized using the straight-line method over the following estimated useful lives: Computer equipment and software 3 - 7 years Furniture and fixtures 5 years Machinery and equipment 5 years Leasehold improvements Shorter of lease term or useful life |
Goodwill and Intangible Assets | Goodwill and Intangible Assets Goodwill represents the excess of the consideration transferred over the estimated fair value of assets acquired and liabilities assumed in a business combination. Intangible assets are measured at their respective fair values as of the acquisition date and may be subject to adjustment within the measurement period, which may be up to one year from the acquisition date. Intangible assets related to acquired in-process research and development (“IPR&D”) projects are considered to be indefinite-lived until the completion or abandonment of the associated research and development efforts. Goodwill and intangible assets with indefinite useful lives are not amortized and are tested for impairment annually, or more frequently if events or changes in circumstances indicate that it is more likely than not that the assets are impaired. Intangible assets of $2.6 million as of December 31, 2021 and 2020 consist of IPR&D. There were no impairments to goodwill or intangible assets When development is successfully completed, which generally occurs when regulatory approval is obtained, the associated assets are deemed finite-lived and amortized over their respective estimated useful lives beginning at that point in time. Intangible assets with finite useful lives are amortized over their estimated useful lives, primarily on a straight-line basis, and are reviewed for impairment when facts or circumstances indicate that the carrying value of these assets may not be recoverable. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets Long-lived assets, including property and equipment and finite-lived intangible assets, are reviewed for impairment whenever facts or circumstances either internally or externally may indicate that the carrying value of an asset may not be recoverable. If there is an indication of impairment, the Company tests for recoverability by comparing the estimated undiscounted future cash flows expected to result from the use of the asset to the carrying amount of the asset or asset group. If the asset or asset group is determined to be impaired, any excess of the carrying value of the asset or asset group over its estimated fair value is recognized as an impairment loss. There were no material impairments recorded during the years ended December 31, 2021, 2020 and 2019. |
Accrued Research and Development Expenses | Accrued Research and Development Expense Clinical trial costs are a component of research and development expense. The Company accrues and expenses clinical trial activities performed by third parties based upon actual work completed in accordance with agreements established with clinical research and manufacturing organizations and clinical sites. The Company determines the actual costs through monitoring patient enrollment, discussions with internal personnel and external service providers regarding the progress or stage of completion of trials or services and the agreed-upon fee to be paid for such services. |
Net Product Revenue, Product Sales Discounts and Allowances and Royalty Revenue | Net Revenues The Company sells to wholesalers and distributors, (collectively, “Customers”). The Customers then resell to hospitals and clinics (collectively, “Healthcare Providers”) pursuant to contracts with the Company. In addition to distribution agreements with Customers and contracts with Healthcare Providers, the Company enters into arrangements with group purchasing organizations (“GPOs”) that provide for United States government-mandated or privately-negotiated rebates, chargebacks and discounts. The Company also enters into rebate arrangements with payers, which consist primarily of commercial insurance companies and government entities, to cover the reimbursement of our products to Healthcare Providers. The Company provides co-payment assistance to patients who have commercial insurance and meet certain eligibility requirements. Revenue from product sales is recognized at the point when a Customer obtains control of the product and the Company satisfies its performance obligation, which generally occurs at the time product is shipped to the Customer. Payment terms differ by jurisdiction and customer, but payment terms typically range from 30 to 67 days from date of shipment. Product Sales Discounts and Allowances Revenue from product sales is recorded at the net sales price (“transaction price”), which includes estimates of variable consideration for which reserves are established and that result from chargebacks, rebates, co-pay assistance, prompt-payment discounts, returns and other allowances that are offered within contracts between the Company and its Customers, Healthcare Providers, payers and GPOs. These reserves are based on the amounts earned or to be claimed on the related sales and are classified as reductions in trade receivables (if the amounts are payable to a Customer) or current liabilities (if the amounts are payable to a party other than a Customer). Where appropriate, these estimates take into consideration a range of possible outcomes that are probability-weighted for relevant factors such as historical experience, current contractual and statutory requirements, specifically known market events and trends, industry data and forecasted Customer buying and payment patterns. Overall, these reserves reflect the best estimates of the amount of consideration to which the Company is entitled based on the terms of its contracts. The amount of variable consideration that is included in the transaction price may be constrained, and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. The actual amount of consideration ultimately received may differ. If actual results in the future vary from the Company’s estimates, the estimates will be adjusted, which will affect net product revenue in the period that such variances become known. Chargebacks: Discounts for Prompt Payment: Rebates: Co-payment Assistance: Product Returns: Other Allowances: Royalty Revenue Royalty revenue from licensees, which is based on sales to third-parties of licensed products, is recorded when the third-party sale occurs and the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). Royalty revenue was insignificant for the periods presented and is included in total revenues. |
Cost of Goods Sold | Cost of Goods Sold Cost of goods sold consists primarily of third-party manufacturing, distribution, and certain overhead costs. A portion of the costs of producing UDENYCA sold to date was expensed as research and development prior to the FDA approval of UDENYCA and, therefore, it is not reflected in the cost of goods sold. During the first quarter of 2021, the UDENYCA inventory with no inventory value was fully utilized. On May 2, 2019, the Company and Amgen settled a trade secret action brought by Amgen. As a result, cost of goods sold reflects a mid-single digit royalty on net product revenue, which began on July 1, 2019. The royalty cost will continue for five years pursuant to the settlement. In 2021, 2020 and 2019, cost of goods sold included write-offs for inventory of $5.1 million, $2.2 million and $0.4 million, respectively, that did not meet the Company’s acceptance criteria, net of credits received from manufacturers. In 2019, cost of goods sold included write-off of prepaid manufacturing costs of $1.3 million due to the cancellation of certain manufacturing reservations. |
Research and Development Expense | Research and Development Expense Research and development expense represents costs incurred to conduct research, such as the discovery and development of our product candidates. The Company recognizes all research and development costs as they are incurred. The Company currently tracks research and development costs incurred on a product candidate basis only for external research and development expenses. The Company’s external research and development expense consists primarily of: ● expense incurred under agreements with consultants, third-party CROs, and investigative sites where a substantial portion of the Company’s preclinical studies and all of its clinical trials are conducted; ● costs of acquiring originator comparator materials and manufacturing preclinical study and clinical trial supplies and other materials from CMOs, and related costs associated with release and stability testing; ● costs associated with manufacturing process development activities; and ● upfront and milestone payments related to licensing and collaboration agreements. Internal costs are associated with activities performed by the Company’s research and development organization and generally benefit multiple programs. These costs are not separately allocated by product candidate. Unallocated, internal research and development costs consist primarily of: ● personnel-related expense, which include salaries, benefits and stock-based compensation; and ● facilities and other allocated expense, which include direct and allocated expense for rent and maintenance of facilities, depreciation and amortization of leasehold improvements and equipment, laboratory and other supplies. Products manufactured prior to regulatory approval may not be sold unless regulatory approval is obtained. The Company expenses manufacturing costs as incurred as research and development expense for products that have not been approved until future commercialization is considered probable and the future economic benefit is expected to be realized, based on management’s judgment. The Company began to capitalize inventory costs associated with UDENYCA after receiving regulatory approval in November 2018. |
License Agreements | License Agreements The Company has entered and may continue to enter into license agreements to access and utilize certain technology. To determine whether the licensing transactions should be accounted for as a business combination or as an asset acquisition, the Company makes certain judgments, which include assessing whether the acquired set of activities and assets would meet the definition of a business under the relevant accounting rules. If the acquired set of activities and assets does not meet the definition of a business, the transaction is recorded as an asset acquisition and therefore, any acquired IPR&D that does not have an alternative future use is charged to expense at the acquisition date. To date none of the Company’s license agreements have been considered to be the acquisition of a business. |
Selling, General and Administrative Expense | Selling, General and Administrative Expense Selling, general and administrative expenses comprise primarily compensation and benefits associated with sales and marketing, finance, human resources, legal, information technology and other administrative personnel, outside marketing, advertising and legal expenses and other general and administrative costs. The Company expenses the cost of advertising, including promotional expenses, as incurred. Advertising expenses were $8.7 million, $3.8 million and $4.5 million in 2021, 2020 and 2019, respectively. |
Stock-Based Compensation | Stock-Based Compensation The Company’s compensation programs include stock-based awards, and the related grants under these programs are accounted for at fair value. The fair values are recognized as compensation expense on a straight-line basis over the vesting period with the related costs recorded in cost of goods sold, research and development, and selling, general and administrative expense, as appropriate. The Company accounts for forfeitures as they occur. |
Income Taxes | Income Taxes The Company utilizes the liability method of accounting for deferred income taxes. Under this method, deferred tax liabilities and assets are recognized for the expected future tax consequences of temporary differences between the carrying amounts and the tax basis of assets and liabilities. A valuation allowance is established against deferred tax assets because, based on the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. The Company’s policy is to record interest and penalties on uncertain tax positions as income tax expense. The Company recognizes uncertain income tax positions at the largest amount that is more likely than not to be sustained upon audit by the relevant taxing authority. The Company does not expect its unrecognized tax benefits to change significantly in 2022. |
Operating and Finance Leases | Operating and Finance Leases The Company determines if an arrangement is a lease at inception. The Company does not recognize right-of-use assets and lease liabilities related to short-term leases. The Company also does not separate lease and non-lease components for its facility and vehicle leases. Operating leases are included in other current liabilities, other assets, non-current, and lease liabilities, non-current in the consolidated balance sheets. The lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise any such options. The Company recognizes operating lease expense for these leases on a straight-line basis over the term of the lease. The term under the Company’s vehicle lease agreement is 36 months. The vehicles leased under this arrangement were classified as finance leases. Finance leases are included in property and equipment, net, accrued and other current liabilities, and lease liabilities, non-current in the consolidated balance sheets and assets under Finance leases are depreciated to operating expenses on a straight-line basis over their estimated useful lives. The operating and finance lease right-of-use assets and the lease liabilities are recognized based on the present value of lease payments over the lease term at the lease commencement date. The Company uses its incremental borrowing rate based on the information available at the commencement date in determining the lease liabilities as the Company's leases generally do not provide an implicit rate. |
Net (Loss) Income per Share | Net (Loss) Income per Share Basic net (loss) income per share is calculated by dividing the net (loss) income by the weighted-average number of shares of common stock outstanding for the period, without consideration for potential dilutive common shares. Diluted net income per share is computed by dividing the net income by the weighted-average number of common shares outstanding for the period plus any potential dilutive common shares outstanding for the period determined using the treasury stock method for options, RSUs and ESPP and using the if-converted method for the convertible notes. Diluted net loss per share is computed by dividing net loss by the weighted-average number of common shares outstanding for the period, without consideration for any potential dilutive common share equivalents as their effect would be antidilutive |
Comprehensive (Loss) Income | Comprehensive (Loss) Income Comprehensive (loss) income is composed of two components: net (loss) income and other comprehensive (loss) income. Other comprehensive (loss) income refers to gains and losses that under U.S. GAAP are recorded as an element of stockholders’ equity, but are excluded from net (loss) income. The Company’s other comprehensive (loss) income include foreign currency translation adjustments in 2021, 2020 and 2019. |
Reclassifications | Reclassifications Certain prior year amounts in the consolidated balance sheets and consolidated statements of cash flows have been reclassified to conform with the current year presentation in 2021. As a result, there was no change to total assets on the consolidated balance sheet or net cash provided by operating activities on the consolidated statements of cash flows for the prior years. |
Organization and Summary of S_3
Organization and Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Organization and Summary of Significant Accounting Policies | |
Schedule of Reconciliation of Cash, Cash Equivalents and Restricted Cash | Year Ended December 31, (in thousands) 2021 2020 2019 At beginning of period: Cash and cash equivalents $ 541,158 $ 177,668 $ 72,356 Restricted cash 440 240 835 Total cash, cash equivalents and restricted cash $ 541,598 $ 177,908 $ 73,191 At end of period: Cash and cash equivalents $ 417,195 $ 541,158 $ 177,668 Restricted cash 440 440 240 Total cash, cash equivalents and restricted cash $ 417,635 $ 541,598 $ 177,908 |
Schedule of Estimated Useful Lives of Property Plant and Equipment | Computer equipment and software 3 - 7 years Furniture and fixtures 5 years Machinery and equipment 5 years Leasehold improvements Shorter of lease term or useful life |
Revenue (Tables)
Revenue (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Revenue | |
Revenue by Significant Customer | Year Ended December 31, 2021 2020 2019 McKesson Corporation 39 % 38 % 42 % AmeriSource-Bergen Corporation 39 % 37 % 33 % Cardinal Health, Inc. 20 % 23 % 23 % Others 2 % 2 % 2 % Total revenue 100 % 100 % 100 % |
Activities and Ending Reserve Balances for Each Significant Category of Discounts and Allowances | Year Ended December 31, 2021 Chargebacks Other Fees, and Discounts Co-pay for Prompt Assistance (in thousands) Payment Rebates and Returns Total Balance at December 31, 2020 $ 40,580 $ 54,058 $ 28,760 $ 123,398 Provision related to sales made in: Current period 470,791 113,705 94,703 679,199 Prior period (2,876) (4,976) (3,555) (11,407) Payments and customer credits issued (478,830) (108,783) (93,854) (681,467) Balance at December 31, 2021 $ 29,665 $ 54,004 $ 26,054 $ 109,723 Year Ended December 31, 2020 Chargebacks Other Fees, and Discounts Co-pay for Prompt Assistance (in thousands) Payment Rebates and Returns Total Balance at December 31, 2019 $ 35,159 $ 27,494 $ 24,494 $ 87,147 Provision related to sales made in: Current period 462,328 115,864 114,372 692,564 Prior period (1,336) (3,438) (6,288) (11,062) Payments and customer credits issued (455,571) (85,862) (103,818) (645,251) Balance at December 31, 2020 $ 40,580 $ 54,058 $ 28,760 $ 123,398 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Fair Value Measurements | |
Financial Assets and Liabilities Measured on a Recurring Basis | Fair Value Measurements December 31, 2021 (in thousands) Level 1 Level 2 Level 3 Total Financial Assets: Cash and cash equivalents (money market funds) $ 417,165 $ — $ — $ 417,165 Restricted cash (money market funds) 440 — — 440 Total financial assets $ 417,605 $ — $ — $ 417,605 Financial Liabilities: Contingent consideration $ — $ — $ 102 $ 102 Fair Value Measurements December 31, 2020 (in thousands) Level 1 Level 2 Level 3 Total Financial Assets: Cash and cash equivalents (money market funds) $ 538,673 $ — $ — $ 538,673 Restricted cash (money market funds) 440 — — 440 Total financial assets $ 539,113 $ — $ — $ 539,113 Financial Liabilities: Contingent consideration $ — $ — $ 102 $ 102 |
Inventory (Tables)
Inventory (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Inventory | |
Schedule of Inventory | Inventory consisted of the following: December 31, (in thousands) 2021 2020 Raw Materials $ 4,870 $ 5,205 Work in process 65,117 43,952 Finished goods 23,265 43,032 Total $ 93,252 $ 92,189 |
Schedule of Balance Sheet Classification | December 31, (in thousands) 2021 2020 Inventory $ 37,642 $ 44,233 Inventory, non-current 55,610 47,956 Total $ 93,252 $ 92,189 |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Organization and Operations | |
Schedule of Property and Equipment, Net | December 31, (in thousands) 2021 2020 Machinery and equipment $ 11,876 $ 13,301 Computer equipment and software 3,033 3,996 Furniture and fixtures 1,129 1,268 Leasehold improvements 5,942 5,830 Finance lease right of use assets 2,294 1,451 Construction in progress 388 312 Total property and equipment 24,662 26,158 Accumulated depreciation and amortization (16,849) (16,050) Property and equipment, net $ 7,813 $ 10,108 |
Schedule of Accrued Liabilities | December 31, (in thousands) 2021 2020 Accrued manufacturing and clinical $ 30,541 $ 11,365 Accrued co-development costs for toripalimab 1,926 — Accrued other 12,168 12,182 Lease liabilities, current 3,492 3,132 Total Accrued and other current liabilities $ 48,127 $ 26,679 |
Debt Obligations (Tables)
Debt Obligations (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
1.5% Convertible Senior Subordinated Notes due 2026 | |
Debt Instrument | |
Components of Convertible Notes | December 31, (in thousands) 2021 2020 Principal amount of the 2026 Convertible Notes $ 230,000 $ 230,000 Unamortized debt discount and debt issuance costs (5,712) (6,971) Total 2026 Convertible Notes $ 224,288 $ 223,029 |
Components of Interest Expense | Year Ended December 31, (in thousands) 2021 2020 Stated coupon interest $ 3,450 $ 2,434 Accretion of debt discount and debt issuance costs 1,259 873 Total interest expense $ 4,709 $ 3,307 |
Schedule of Future Payments on Debt | Future payments on the 2026 Convertible Notes as of December 31, 2021 are as follows: Year ending December 31, (in thousands) 2022 $ 3,450 2023 3,450 2024 3,450 2025 3,450 2026 and beyond 231,725 Total minimum payments 245,525 Less amount representing interest (15,525) 2026 Convertible Notes, principal amount 230,000 Less debt discount and debt issuance costs on 2026 Convertible Notes (5,712) Net carrying amount of 2026 Convertible Notes $ 224,288 |
8.2% Convertible Notes due 2022 | |
Debt Instrument | |
Components of Convertible Notes | December 31, (in thousands) 2021 2020 Principal amount of the 2022 Convertible Notes $ 81,750 $ 81,750 Unamortized debt discount and debt issuance costs (391) (1,865) 2022 Convertible Notes $ 81,359 $ 79,885 Principal amount of the 2022 Convertible Notes - related parties $ 27,250 $ 27,250 Unamortized debt discount and debt issuance costs - related parties (130) (622) 2022 Convertible Notes - related parties $ 27,120 $ 26,628 Total 2022 Convertible Notes, net carrying amount $ 108,479 $ 106,513 |
Components of Interest Expense | Year Ended December 31, (in thousands) 2021 2020 2019 Stated coupon interest $ 6,150 $ 6,150 $ 6,150 Accretion of debt discount and debt issuance costs 1,475 1,343 1,223 Interest expense $ 7,625 $ 7,493 $ 7,373 Stated coupon interest - related parties $ 2,050 $ 2,050 $ 2,050 Accretion of debt discount and debt issuance costs - related parties 491 448 407 Interest expense - related parties $ 2,541 $ 2,498 $ 2,457 Total interest expense $ 10,166 $ 9,991 $ 9,830 |
2025 Term Loan | |
Debt Instrument | |
Components of Convertible Notes | December 31, (in thousands) 2021 2020 Principal amount of the 2025 Term Loan $ 75,000 $ 75,000 Exit fee due on payment of 2025 Term Loan 3,000 3,000 2025 Term Loan, gross 78,000 78,000 Unamortized exit fee, debt discount and debt issuance costs, net (2,487) (3,519) Net carrying amount of 2025 Term Loan $ 75,513 $ 74,481 |
Components of Interest Expense | Year Ended December 31, (in thousands) 2021 2020 2019 Stated coupon interest $ 7,034 $ 7,053 $ 7,063 Accretion of debt discount and debt issuance costs 1,032 818 709 Interest expense $ 8,066 $ 7,871 $ 7,772 |
Schedule of Future Payments on Debt | Year ending December 31, (in thousands) 2022 $ 29,294 2023 27,130 2024 24,972 2025 8,780 Total minimum payments 90,176 Less amount representing interest (12,176) 2025 Term Loan, gross 78,000 Less unamortized exit fee, debt discount and debt issuance costs, net (2,487) Net carrying amount of 2025 Term Loan $ 75,513 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies. | |
Schedule of Non-cancelable Contractual Obligations | Years ending December 31, (in thousands) 2022 $ 27,052 2023 16,300 2024 10,108 2025 268 2026 179 Total obligations $ 53,907 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Leases | |
Schedule of Balance Sheet Classification of Lease Assets and Liabilities | (in thousands) December 31, Assets Balance Sheet Classification 2021 2020 Operating lease Other assets, non-current $ 8,193 $ 9,956 Finance lease Property and equipment, net 1,220 1,451 Total leased assets $ 9,413 $ 11,407 (in thousands) December 31, Liabilities Balance Sheet Classification 2021 2020 Operating lease liabilities, current Accrued and other current liabilities $ 2,751 $ 2,573 Operating lease liabilities, non-current Lease liabilities, non-current 6,753 9,073 Total operating lease liabilities $ 9,504 $ 11,646 Finance lease liabilities, current Accrued and other current liabilities $ 741 $ 560 Finance lease liabilities, non-current Lease liabilities, non-current 498 875 Total finance lease liabilities $ 1,239 $ 1,435 |
Schedule of maturities of the operating and finance lease liabilities | As of December 31, 2021, the maturities of the lease liabilities were as follows: Years ending December 31, (in thousands) Operating leases Finance leases 2022 $ 3,401 $ 790 2023 3,560 449 2024 3,014 61 2025 412 — 2026 and thereafter 416 — Total lease payments 10,803 1,300 Less imputed interest (1,299) (61) Lease liabilities $ 9,504 $ 1,239 |
Stock-Based Compensation and _2
Stock-Based Compensation and Employee Benefits (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Stock-Based Compensation | |
Summary of Option Activities under 2016 and 2014 Plans | Options Outstanding Weighted- Number of Average Options Exercise Price Balances at December 31, 2020 19,014,835 $ 15.41 Granted - at fair value 4,559,125 $ 16.62 Exercised (1,316,361) $ 7.91 Forfeited/Canceled (2,297,784) $ 17.96 Balances at December 31, 2021 19,959,815 $ 15.89 |
Summary of Additional Information Related to Status of Options | Additional information related to the status of options as of December 31, 2021 is summarized as follows: Weighted- Weighted- Average Aggregate Average Remaining Intrinsic Number of Exercise Contractual Terms Value (in Options Price (Years) thousands) Options outstanding 19,959,815 $ 15.89 6.4 $ 47,892 Options vested and exercisable 13,453,683 $ 15.56 5.4 $ 43,291 |
Summary of RSU Activity, under 2014 Plan | RSUs Outstanding Weighted-Average Number of Grant Date Fair RSUs Value Balances at December 31, 2020 1,009,657 $ 17.91 RSUs granted 1,652,512 $ 16.86 RSUs vested (465,930) $ 18.10 RSUs canceled (352,507) $ 17.54 Balances at December 31, 2021 1,843,732 $ 17.00 |
Schedule of Stock-Based Compensation Expense | Year Ended December 31, (in thousands) 2021 2020 2019 Cost of goods sold (1) $ 1,099 $ 583 $ 108 Research and development 18,688 13,837 12,912 Selling, general and administrative 31,577 23,740 20,571 Stock-based compensation expense $ 51,364 $ 38,160 $ 33,591 Capitalized stock-based compensation expense into inventory $ 1,025 $ 1,460 $ 1,735 (1) Stock-based compensation capitalized into inventory is recognized as cost of sales when the related product is sold. |
Schedule of Weighted Average Assumptions for Black-Scholes Option-Pricing Model Used in Determining Fair Value of Awards | Year Ended December 31, 2021 2020 2019 Expected term (years) Stock options 6.08 6.10 6.00 ESPP 0.50 0.50 0.50 Expected volatility Stock options 65 % 68 % 69 % ESPP 42 % 58 % 61 % Risk-free interest rate Stock options 0.89 % 1.09 % 2.29 % ESPP 0.06 % 0.13 % 1.89 % Expected dividend yield Stock options — % — % — % ESPP — % — % — % |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Income Taxes | |
Components of Income (Loss) Before Income Taxes | Year Ended December 31, (in thousands) 2021 2020 2019 Domestic $ (287,058) $ 133,615 $ 92,585 Foreign (42) 2,092 190 Total $ (287,100) $ 135,707 $ 92,775 |
Schedule of Provision For (Benefit From) Income Taxes | Year Ended December 31, (in thousands) 2021 2020 2019 Current: Federal $ — $ — $ — State — 3,463 2,942 Foreign — — — Subtotal $ — $ 3,463 $ 2,942 Deferred: Federal $ — $ — $ — State — — — Foreign — — — Subtotal $ — $ — $ — Provision for income taxes $ — $ 3,463 $ 2,942 |
Reconciliation of Statutory U.S. Federal Rate | Year Ended December 31, 2021 2020 2019 Percent of pre-tax income: United States federal statutory income tax rate 21.0 % 21.0 % 21.0 % State taxes, net of federal benefit 2.6 2.0 1.5 Foreign rate differences (0.0) (0.3) (0.1) Permanent items 0.2 0.4 (0.6) Research and development credit 2.6 (4.8) (4.8) Stock based compensation costs (1.2) 1.3 1.3 Other (0.0) (0.3) (0.7) Change in valuation allowance (25.2) (16.7) (14.4) Effective income tax rate (0.0) % 2.6 % 3.2 % |
Components of Net Deferred Tax Assets | December 31, (in thousands) 2021 2020 Net operating loss carryforwards $ 117,793 $ 94,043 Research and development credits 58,039 49,965 Depreciation and amortization 40,620 9,672 Stock-based compensation 30,565 25,983 Sales related accruals 17,299 16,404 Other accruals 11,798 8,013 Gross deferred tax assets 276,114 204,080 Right-of-use asset (2,167) (2,566) In-process research and development (603) (589) Gross deferred tax liabilities (2,770) (3,155) Total net deferred tax asset 273,344 200,925 Less valuation allowance (273,344) (200,925) Net deferred tax assets $ — $ — |
Reconciliation of Unrecognized Tax Benefits | Year Ended December 31, (in thousands) 2021 2020 2019 Balance at beginning of year $ 13,243 $ 11,603 $ 18,115 Additions based on tax positions related to current year 2,038 1,749 1,206 Additions (reductions) for tax positions of prior years 214 (109) (7,718) Balance at end of year $ 15,495 $ 13,243 $ 11,603 |
Net (Loss) Income Per Share (Ta
Net (Loss) Income Per Share (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Net (Loss) Income Per Share | |
Computation of Basic and Diluted Net (loss) Income Per Share | Years Ended December 31, (in thousands, except share and per share data) 2021 2020 2019 Basic net (loss) income per share Numerator: Net (loss) income $ (287,100) $ 132,244 $ 89,833 Denominator: Weighted-average common shares outstanding 75,449,632 71,411,705 69,679,916 Basic net (loss) income per share $ (3.81) $ 1.85 $ 1.29 Diluted net (loss) income per share Numerator: Net (loss) income $ (287,100) $ 132,244 $ 89,833 Add interest expense on 2026 Convertible Notes, net of tax — 3,307 — Numerator for diluted net (loss) income per share (287,100) 135,551 89,833 Denominator: Denominator for basic net (loss) income per share 75,449,632 71,411,705 69,679,916 Add effect of potential dilutive securities: Stock options, including shares subject to ESPP — 3,455,646 3,491,272 Restricted stock units — 167,597 14,755 Shares issuable upon conversion of convertible notes — 8,456,950 — Denominator for diluted net (loss) income per share 75,449,632 83,491,898 73,185,943 Diluted net (loss) income per share $ (3.81) $ 1.62 $ 1.23 |
Outstanding Dilutive Potential Shares Excluded from Calculation of Diluted Net (loss) Income Per Share | The following outstanding dilutive potential shares were excluded from the calculation of diluted net (loss) income per share due to their anti-dilutive effect: The following outstanding dilutive potential shares were excluded from the calculation of diluted net (loss) income per share due to their anti-dilutive effect:he following outstanding dilutive potential shares were excluded from the calculation of diluted net (loss) income per share due to their anti-dilutive effect: Year Ended December 31, 2021 2020 2019 Stock options, including shares subject to ESPP 19,895,097 9,521,403 10,412,471 Restricted stock units 1,811,607 7,689 22,068 Shares issuable upon conversion of 2022 Convertible Notes 4,473,871 4,473,871 4,473,871 Shares issuable upon conversion of 2026 Convertible Notes 11,942,152 — — Total 38,122,727 14,002,963 14,908,410 |
Organization and Significant Ac
Organization and Significant Accounting Policies - Organization (Details) | 12 Months Ended |
Dec. 31, 2021item | |
Organization and Summary of Significant Accounting Policies | |
Product pipeline, number of drug candidates | 3 |
Number of reportable and operating segments | 1 |
Organization and Significant _2
Organization and Significant Accounting Policies - Cash, Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Organization and Summary of Significant Accounting Policies | |||
Cash and cash equivalents, beginning of period | $ 541,158 | $ 177,668 | $ 72,356 |
Restricted cash, beginning of period | 440 | 240 | 835 |
Cash, cash equivalents and restricted cash, beginning of period | 541,598 | 177,908 | 73,191 |
Cash and cash equivalents, end of period | 417,195 | 541,158 | 177,668 |
Restricted cash, end of period | 440 | 440 | 240 |
Cash, cash equivalents and restricted cash at end of period | $ 417,635 | $ 541,598 | $ 177,908 |
Organization and Significant _3
Organization and Significant Accounting Policies - Investments in Marketable Securities (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Organization and Summary of Significant Accounting Policies | |||
Interest income from marketable securities | $ 1.4 | $ 0.6 | $ 1.6 |
Organization and Significant _4
Organization and Significant Accounting Policies - Property and Equipment (Details) | 12 Months Ended |
Dec. 31, 2021 | |
Furniture and Fixtures | |
Property and Equipment, Net | |
Estimated useful lives | 5 years |
Machinery and Equipment | |
Property and Equipment, Net | |
Estimated useful lives | 5 years |
Leasehold Improvements | |
Property and Equipment, Net | |
Estimated useful lives, description | Shorter of lease term or useful life |
Maximum | Computer Equipment and Software | |
Property and Equipment, Net | |
Estimated useful lives | 7 years |
Minimum | Computer Equipment and Software | |
Property and Equipment, Net | |
Estimated useful lives | 3 years |
Organization and Significant _5
Organization and Significant Accounting Policies - Goodwill, Intangible Assets and Impairment of Long-lived Assets (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Acquired Finite-Lived Intangible Assets [Line Items] | |||
Intangible assets, adjustment, measurement period | 1 year | ||
Intangible assets | $ 2,620,000 | $ 2,620,000 | |
Impairment of intangible assets excluding goodwill | 0 | ||
Impairment of goodwill | 0 | 0 | $ 0 |
Long lived assets, material impairments | 0 | 0 | $ 0 |
In-process research and development | |||
Acquired Finite-Lived Intangible Assets [Line Items] | |||
Intangible assets | $ 2,600,000 | $ 2,600,000 |
Organization and Significant _6
Organization and Significant Accounting Policies - Net Revenues (Details) | 12 Months Ended |
Dec. 31, 2021 | |
Revenue, Performance Obligation, Description of Payment Terms | Payment terms differ by jurisdiction and customer, but payment terms typically range from 30 to 67 days from date of shipment. |
Maximum | |
Payment terms from date of shipment, period | 67 days |
Minimum | |
Payment terms from date of shipment, period | 30 days |
Organization and Significant _7
Organization and Significant Accounting Policies - Cost of Goods Sold (Details) - USD ($) $ in Thousands | Jul. 01, 2019 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Organization and Summary of Significant Accounting Policies | ||||
Royalty payment term | 5 years | |||
Write-off of inventory that did not meet acceptance criteria | $ 5,133 | $ 2,171 | $ 395 | |
Write-off of prepaid manufacturing costs | $ 1,300 |
Organization and Significant _8
Organization and Significant Accounting Policies - Selling, General and Administrative Expense (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Organization and Summary of Significant Accounting Policies | |||
Advertising expenses | $ 8.7 | $ 3.8 | $ 4.5 |
Organization and Significant _9
Organization and Significant Accounting Policies - Operating and Finance Leases (Details) | Dec. 31, 2021 |
Organization and Summary of Significant Accounting Policies | |
Term of leases | 36 months |
Revenue - Additional Informatio
Revenue - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Concentration of Revenue [Line Items] | |||
Net product revenue | $ 326,551 | $ 475,824 | $ 356,071 |
Sales of UDENYCA | |||
Concentration of Revenue [Line Items] | |||
Net product revenue | $ 326,600 | $ 475,800 | $ 356,100 |
Revenue - Revenue by Significan
Revenue - Revenue by Significant Customer (Details) - Net Product Revenue - Customer Concentration Risk | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Concentration Risk | |||
Percentage of total revenue | 100.00% | 100.00% | 100.00% |
McKesson | |||
Concentration Risk | |||
Percentage of total revenue | 39.00% | 38.00% | 42.00% |
AmeriSource-Bergen Corp | |||
Concentration Risk | |||
Percentage of total revenue | 39.00% | 37.00% | 33.00% |
Cardinal | |||
Concentration Risk | |||
Percentage of total revenue | 20.00% | 23.00% | 23.00% |
Others | |||
Concentration Risk | |||
Percentage of total revenue | 2.00% | 2.00% | 2.00% |
Revenue - Activities and Ending
Revenue - Activities and Ending Reserve Balances for Each Significant Category of Discounts and Allowances (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Accounts Notes And Loans Receivable | ||
Activities and reserve balance, beginning balance | $ 123,398 | $ 87,147 |
Provision related to sales made in: | ||
Current period | 679,199 | 692,564 |
Prior period | (11,407) | (11,062) |
Payments and customer credits issued | (681,467) | (645,251) |
Activities and reserve balance, ending balance | 109,723 | 123,398 |
Chargebacks and Discounts for Prompt Payment | ||
Accounts Notes And Loans Receivable | ||
Activities and reserve balance, beginning balance | 40,580 | 35,159 |
Provision related to sales made in: | ||
Current period | 470,791 | 462,328 |
Prior period | (2,876) | (1,336) |
Payments and customer credits issued | (478,830) | (455,571) |
Activities and reserve balance, ending balance | 29,665 | 40,580 |
Rebates | ||
Accounts Notes And Loans Receivable | ||
Activities and reserve balance, beginning balance | 54,058 | 27,494 |
Provision related to sales made in: | ||
Current period | 113,705 | 115,864 |
Prior period | (4,976) | (3,438) |
Payments and customer credits issued | (108,783) | (85,862) |
Activities and reserve balance, ending balance | 54,004 | 54,058 |
Other Fees, Co-pay Assistance and Returns | ||
Accounts Notes And Loans Receivable | ||
Activities and reserve balance, beginning balance | 28,760 | 24,494 |
Provision related to sales made in: | ||
Current period | 94,703 | 114,372 |
Prior period | (3,555) | (6,288) |
Payments and customer credits issued | (93,854) | (103,818) |
Activities and reserve balance, ending balance | $ 26,054 | $ 28,760 |
Fair Value Measurements - Finan
Fair Value Measurements - Financial Assets and Liabilities Measured on a Recurring Basis (Details) - Fair Value Measurements Recurring Basis - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | $ 417,605 | $ 539,113 |
Level 1 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 0 | |
Level 1 | Contingent Consideration | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial liabilities | 0 | |
Level 2 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 0 | |
Level 2 | Contingent Consideration | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial liabilities | 102 | 102 |
Level 3 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 417,605 | 539,113 |
Level 3 | Contingent Consideration | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial liabilities | 102 | 102 |
Money Market Funds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 417,165 | 538,673 |
Money Market Funds | Level 1 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 0 | |
Money Market Funds | Level 2 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 0 | |
Money Market Funds | Level 3 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 417,165 | 538,673 |
Restricted Cash (Money Market Funds) | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 440 | 440 |
Restricted Cash (Money Market Funds) | Level 1 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 0 | |
Restricted Cash (Money Market Funds) | Level 2 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 0 | |
Restricted Cash (Money Market Funds) | Level 3 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | $ 440 | $ 440 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) - USD ($) $ in Millions | 12 Months Ended | |||
Dec. 31, 2021 | Dec. 31, 2020 | Apr. 30, 2020 | Feb. 29, 2016 | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||
Fair Value, Assets, Level 1 to Level 2 Transfers, Amount | $ 0 | |||
Fair Value, Assets, Level 2 to Level 1 Transfers, Amount | 0 | |||
Fair Value, Liabilities, Level 1 to Level 2 Transfers, Amount | 0 | |||
Fair Value, Liabilities, Level 2 to Level 1 Transfers, Amount | 0 | |||
Fair Value, Measurement with Unobservable Inputs Reconciliation, Recurring Basis, Asset, Transfers, Net | 0 | |||
Fair Value, Measurement with Unobservable Inputs Reconciliation, Recurring Basis, Liability, Transfers, Net | 0 | |||
Premium | $ 9 | |||
1.5% Convertible Senior Subordinated Notes due 2026 | ||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||
Stated interest rate | 1.50% | |||
Aggregate principal amount | $ 230 | |||
8.2% Convertible Notes due 2022 | ||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||
Stated interest rate | 8.20% | |||
Aggregate principal amount | $ 100 | |||
2025 Term Loan | ||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||
Aggregate principal amount | 75 | |||
Level 2 | 1.5% Convertible Senior Subordinated Notes due 2026 | ||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||
Debt instrument fair value | 271.9 | $ 269.1 | ||
Level 3 | 8.2% Convertible Notes due 2022 | ||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||
Debt instrument fair value | 108.4 | 113.7 | ||
Other liabilities, non-current | ||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||
Fair value of the contingent consideration | $ 0.1 | $ 0.1 |
Inventory (Details)
Inventory (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Inventory | ||
Raw materials | $ 4,870 | $ 5,205 |
Work in process | 65,117 | 43,952 |
Finished goods | 23,265 | 43,032 |
Total | $ 93,252 | $ 92,189 |
Inventory - Balance Sheet Class
Inventory - Balance Sheet Classifications (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Inventory | ||
Inventory | $ 37,642 | $ 44,233 |
Inventory, non-current | 55,610 | 47,956 |
Total | $ 93,252 | $ 92,189 |
Inventory - Additional Informat
Inventory - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Inventory [Line Items] | |||
Prepayment made for manufacturing services | $ 13,666 | $ 19,429 | |
Other assets, non-current | 10,025 | 12,543 | |
Operating lease right-of-use assets | $ 8,193 | $ 9,956 | |
Operating Lease, Right-of-Use Asset, Statement of Financial Position [Extensible List] | Other assets, non-current | Other assets, non-current | |
Impairment charge within research and development expenses | $ 3,210 | ||
Research and development | 363,105 | $ 142,759 | $ 94,188 |
Prepayments made to a CMO for manufacturing services for UDENYCA | 8,300 | 8,900 | |
Prepayments made to a CMO For Other Research And Development Pipeline Program | 5,400 | $ 10,500 | |
CHS-2020 | |||
Inventory [Line Items] | |||
Research and development | $ 11,200 |
Balance Sheet Components - Sche
Balance Sheet Components - Schedule of Property and Equipment, Net (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Property and Equipment, Net | ||
Total property and equipment | $ 24,662 | $ 26,158 |
Accumulated depreciation and amortization | (16,849) | (16,050) |
Property and equipment, net | 7,813 | 10,108 |
Machinery and Equipment | ||
Property and Equipment, Net | ||
Total property and equipment | 11,876 | 13,301 |
Computer Equipment and Software | ||
Property and Equipment, Net | ||
Total property and equipment | 3,033 | 3,996 |
Furniture and Fixtures | ||
Property and Equipment, Net | ||
Total property and equipment | 1,129 | 1,268 |
Leasehold Improvements | ||
Property and Equipment, Net | ||
Total property and equipment | 5,942 | 5,830 |
Finance lease right of use assets | ||
Property and Equipment, Net | ||
Total property and equipment | 2,294 | 1,451 |
Construction in Progress | ||
Property and Equipment, Net | ||
Total property and equipment | $ 388 | $ 312 |
Balance Sheet Components - Addi
Balance Sheet Components - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Balance Sheet Components | |||
Depreciation and amortization | $ 3,454 | $ 2,888 | $ 3,259 |
Material impairments of property and equipment | $ 0 | $ 0 | $ 0 |
Balance Sheet Components - Accr
Balance Sheet Components - Accrued and Other Current Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Balance Sheet Components | ||
Accrued manufacturing and clinical | $ 30,541 | $ 11,365 |
Accrued co-development costs for toripalimab | 1,926 | |
Accrued other | 12,168 | 12,182 |
Lease liabilities, current | 3,492 | 3,132 |
Total Accrued and other current liabilities | $ 48,127 | $ 26,679 |
Collaborations and Other Arra_2
Collaborations and Other Arrangements (Details) $ / shares in Units, $ in Thousands, € in Millions | Apr. 16, 2021USD ($)$ / sharesshares | Feb. 01, 2021USD ($) | Jan. 13, 2020USD ($) | Nov. 04, 2019EUR (€) | Oct. 04, 2019 | Jan. 31, 2022USD ($) | Mar. 31, 2021USD ($) | Dec. 31, 2020USD ($)$ / shares | Dec. 31, 2021USD ($)$ / shares | Dec. 31, 2020USD ($)$ / shares | Dec. 31, 2019USD ($) | Dec. 31, 2019EUR (€) | Apr. 14, 2020$ / shares |
Collaborative Arrangements And Noncollaborative Arrangement Transactions | |||||||||||||
Research and development expense | $ 363,105 | $ 142,759 | $ 94,188 | ||||||||||
Accounts payable | $ 15,201 | 16,159 | 15,201 | ||||||||||
Accrued and other current liabilities | $ 26,679 | $ 48,127 | $ 26,679 | ||||||||||
Common Stock Par Or Stated Value Per Share | $ / shares | $ 0.0001 | $ 0.0001 | $ 0.0001 | ||||||||||
Share Price | $ / shares | $ 15.96 | $ 14.815 | |||||||||||
Bioeq IP AG | |||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | |||||||||||||
Initial term of agreement | 10 years | ||||||||||||
Percentage of gross profits shraed | 50.00% | ||||||||||||
Bioeq IP AG | Licensed Products | |||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | |||||||||||||
Maximum aggregate milestone payments | € | € 12.5 | ||||||||||||
Bioeq IP AG | Research and Development Expense | |||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | |||||||||||||
Upfront and milestone payment | $ 11,100 | € 10 | |||||||||||
Innovent Biologics (Suzhou) Co., Ltd. | Licensed Products | |||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | |||||||||||||
Initial term of agreement | 12 months | ||||||||||||
Innovent Biologics (Suzhou) Co., Ltd. | Bevacizumab Licensed Product | |||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | |||||||||||||
Collaboration Agreement, upfront amount paid | $ 5,000 | ||||||||||||
Maximum aggregate milestone payments | 40,000 | ||||||||||||
Innovent Biologics (Suzhou) Co., Ltd. | Rituxan option | |||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | |||||||||||||
Maximum aggregate milestone payments | 40,000 | ||||||||||||
License Agreement Fee | 5,000 | ||||||||||||
Innovent Biologics (Suzhou) Co., Ltd. | Technology transfer | |||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | |||||||||||||
License Agreement Fee | $ 10,000 | ||||||||||||
Innovent Biologics (Suzhou) Co., Ltd. | Research and Development Expense | Bevacizumab Licensed Product | |||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | |||||||||||||
Upfront and milestone payment | $ 7,500 | ||||||||||||
Research and development expense | $ 1,100 | ||||||||||||
Collaboration Agreement | |||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | |||||||||||||
Research and development expense | 39,400 | ||||||||||||
Collaboration Agreement | Accrued and other current liabilities | |||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | |||||||||||||
Co-development, regulatory and technology transfer costs | 1,900 | ||||||||||||
Collaboration Agreement | Licensed Products | |||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | |||||||||||||
Maximum paid amount for co-development activities (per licensed compound) | $ 25,000 | ||||||||||||
Junshi Biosciences | |||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | |||||||||||||
Share Price | $ / shares | $ 20.06 | ||||||||||||
Unregistered shares | shares | 2,491,988 | ||||||||||||
Aggregate value | $ 50,000 | ||||||||||||
Period before the company can sell, transfer or make any short sale of common stock (in years) | 2 years | ||||||||||||
Fair value for the discount for lack of marketability (DLOM) | $ 9,000 | ||||||||||||
Junshi Biosciences | Toripalimab | |||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | |||||||||||||
Collaboration Agreement, upfront amount paid | $ 150,000 | ||||||||||||
Research and development expense | $ 145,000 | ||||||||||||
Collaboration agreement, royalty on net sales, percentage | 20.00% | ||||||||||||
Collaboration agreement, threshold royalty payments | $ 380,000 | ||||||||||||
Junshi Biosciences | Anti-TIGIT Antibody and IL-2 cytokine | |||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | |||||||||||||
License Agreement Fee | $ 35,000 | ||||||||||||
Collaboration agreement, royalty on net sales for each exercised option, percentage | 18.00% | ||||||||||||
Collaboration agreement, Maximum aggregate one-time payment for achievement of milestones, for each option program | $ 255,000 | ||||||||||||
Right of First Negotiation Agreement with Junshi Biosciences | |||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | |||||||||||||
Research and development expense | $ 5,000 | ||||||||||||
Subsequent Event | Junshi Biosciences | Anti-TIGIT Antibody and IL-2 cytokine | |||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | |||||||||||||
Upfront and milestone payment | $ 35,000 |
Debt Obligations - Convertible
Debt Obligations - Convertible Senior Subordinated Notes due 2026 Narrative (Details) | 1 Months Ended | 12 Months Ended | ||
Apr. 30, 2020USD ($)$ / sharesshares | Dec. 31, 2021USD ($)item$ / shares | Dec. 31, 2020USD ($) | Apr. 14, 2020$ / shares | |
Debt Instrument | ||||
Net proceeds from offering | $ 222,156,000 | |||
Closing stock, price per share | $ / shares | $ 15.96 | $ 14.815 | ||
1.5% Convertible Senior Subordinated Notes due 2026 | ||||
Debt Instrument | ||||
Aggregate principal amount | $ 230,000,000 | |||
Stated interest rate | 1.50% | |||
Number of events in default | item | 0 | |||
Contractual term | 6 years | |||
Convertible Notes | 1.5% Convertible Senior Subordinated Notes due 2026 | ||||
Debt Instrument | ||||
Aggregate principal amount | $ 230,000,000 | $ 230,000,000 | 230,000,000 | |
Stated interest rate | 1.50% | |||
Net proceeds from offering | $ 222,200,000 | |||
Initial conversion rate, shares of common stock | shares | 51.9224 | |||
Principal amount of notes converted into shares | $ 1,000 | |||
Initial conversion price per common share | $ / shares | $ 19.26 | |||
Interest rate description | The 2026 Convertible Notes accrue interest at a rate of 1.5% per annum, payable semi-annually in arrears on April 15 and October 15 of each year, since October 15, 2020, and will mature on April 15, 2026, unless earlier repurchased or converted. | |||
Debt instrument maturity date | Apr. 15, 2026 | |||
Convertible notes, premium percentage | 30.00% | |||
Convertible notes, covenant compliance | As of December 31, 2021, the Company was in full compliance with these covenants and there were no events of default under the 2026 Convertible Notes. | |||
Debt issuance costs | $ 900,000 | |||
Remaining unamortized debt discount and debt offering costs | $ 5,712,000 | $ 6,971,000 | ||
Effective interest rate | 2.10% | |||
Debt Instrument Term | 4 years 3 months 18 days | |||
Convertible Notes | 1.5% Convertible Senior Subordinated Notes due 2026 | Scenario, Plan | ||||
Debt Instrument | ||||
Convertible notes, converted amount | $ 190,600,000 |
Debt Obligations - Capped Call
Debt Obligations - Capped Call Transactions Narrative (Details) $ / shares in Units, $ in Millions | 1 Months Ended | ||
Apr. 30, 2020USD ($)$ / shares | Dec. 31, 2021$ / shares | Apr. 14, 2020$ / shares | |
Option Indexed to Issuer's Equity [Line Items] | |||
Closing stock, price per share | $ 15.96 | $ 14.815 | |
Capped Call Transactions in connection with the 2026 Convertible Notes | |||
Option Indexed to Issuer's Equity [Line Items] | |||
Payment for capped call transactions | $ | $ 18.2 | ||
Initial cap price of capped call transactions. | $ 25.9263 | ||
Percentage of cap price | 75 |
Debt Obligations - 2026 Convert
Debt Obligations - 2026 Convertible Notes Components (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 | Apr. 30, 2020 |
Debt Instrument | |||
Total 2026 Convertible Notes | $ 224,288 | $ 223,029 | |
1.5% Convertible Senior Subordinated Notes due 2026 | |||
Debt Instrument | |||
Principal amount of the Convertible Notes | $ 230,000 | ||
1.5% Convertible Senior Subordinated Notes due 2026 | Convertible Notes | |||
Debt Instrument | |||
Principal amount of the Convertible Notes | 230,000 | 230,000 | $ 230,000 |
Unamortized debt discount and debt issuance costs | (5,712) | (6,971) | |
Total 2026 Convertible Notes | 224,288 | 223,029 | |
Remaining unamortized debt discount and debt offering costs | $ 5,712 | $ 6,971 |
Debt Obligations - 2026 Conve_2
Debt Obligations - 2026 Convertible Notes Interest Expense Components (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Debt Instrument | |||
Accretion of debt discount and debt issuance costs | $ 4,257 | $ 3,481 | $ 2,339 |
1.5% Convertible Senior Subordinated Notes due 2026 | Convertible Notes | |||
Debt Instrument | |||
Stated coupon interest | 3,450 | 2,434 | |
Accretion of debt discount and debt issuance costs | 1,259 | 873 | |
Total interest expense | $ (4,709) | $ (3,307) |
Debt Obligations - 2026 Conve_3
Debt Obligations - 2026 Convertible Notes Future Payments (Details) - Convertible Notes - 1.5% Convertible Senior Subordinated Notes due 2026 - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Debt Instrument | ||
2022 | $ 3,450 | |
2023 | 3,450 | |
2024 | 3,450 | |
2025 | 3,450 | |
2026 and beyond | 231,725 | |
Total minimum payments | 245,525 | |
Less amount representing interest | (15,525) | |
2026 Convertible Notes, principal amount | 230,000 | |
Less debt discount and debt issuance costs on 2026 Convertible Notes | (5,712) | $ (6,971) |
Net carrying amount of 2025 Convertible Notes | $ 224,288 |
Debt Obligations - Convertibl_2
Debt Obligations - Convertible Notes due 2022 Narrative (Details) | Feb. 29, 2016USD ($)item$ / sharesshares | Dec. 31, 2021USD ($)$ / shares | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | Apr. 14, 2020$ / shares |
Debt Instrument | |||||
Proceeds from issuance of Convertible Notes | $ 222,156,000 | ||||
Convertible trading days | item | 15 | ||||
Closing stock, price per share | $ / shares | $ 15.96 | $ 14.815 | |||
8.2% Convertible Notes due 2022 | |||||
Debt Instrument | |||||
Aggregate principal amount | $ 100,000,000 | ||||
Stated interest rate | 8.20% | ||||
Interest rate description | The 2022 Convertible Notes bear interest at a fixed coupon rate of 8.2% per annum payable quarterly in arrears on March 31, June 30, September 30 and December 31 of each year, since March 31, 2016 | ||||
Convertible notes, premium percentage | 9.00% | ||||
Convertible Notes | KKR Member | |||||
Debt Instrument | |||||
Aggregate principal amount | $ 20,000,000 | ||||
Convertible Notes | MX II Member | |||||
Debt Instrument | |||||
Aggregate principal amount | 4,000,000 | ||||
Convertible Notes | KMGCP Member | |||||
Debt Instrument | |||||
Aggregate principal amount | 1,000,000 | ||||
Convertible Notes | Lender | KKR Member | |||||
Debt Instrument | |||||
Aggregate principal amount | 75,000,000 | ||||
Convertible Notes | 8.2% Convertible Notes due 2022 | |||||
Debt Instrument | |||||
Aggregate principal amount | $ 100,000,000 | $ 81,750,000 | 81,750,000 | ||
Stated interest rate | 8.20% | ||||
Proceeds from issuance of Convertible Notes | $ 99,200,000 | ||||
Convertible notes, Issuance Cost | $ 800,000 | ||||
Principal amount outstanding | 111,100,000 | ||||
Contractual future interest payments due in 2022 | 2,100,000 | ||||
Interest expense | 7,625,000 | 7,493,000 | $ 7,373,000 | ||
Debt instrument maturity date | Mar. 31, 2022 | ||||
Convertible notes, premium percentage | 9.00% | ||||
Additional interest to be accrued upon failure of registration or reporting requirements | 0.50% | ||||
Initial conversion rate, shares of common stock | shares | 44.7387 | ||||
Principal amount of notes converted into shares | $ 1,000 | ||||
Initial conversion price per common share | $ / shares | $ 22.35 | ||||
Initial conversion price, percentage premium over average last reported sale price of common stock | 60 | ||||
Percentage of applicable conversion price, threshold | 160.00% | ||||
Consecutive trading days | item | 30 | ||||
Percentage to pay in cash of the par value of notes | 109.00% | ||||
Remaining unamortized debt discount and debt offering costs | 391,000 | 1,865,000 | |||
Convertible Notes | 8.2% Convertible Notes due 2022 | Related parties | |||||
Debt Instrument | |||||
Aggregate principal amount | 27,250,000 | 27,250,000 | |||
Interest expense | 2,541,000 | 2,498,000 | $ 2,457,000 | ||
Remaining unamortized debt discount and debt offering costs | 130,000 | $ 622,000 | |||
Remaining total unamortized debt discount and debt offering costs , including related parties | $ 500,000 | ||||
Amortized effective interest rate convertible notes period | 3 months | ||||
Effective interest rate | 9.50% | ||||
Convertible Notes | 8.2% Convertible Notes due 2022 | Minimum | |||||
Debt Instrument | |||||
Convertible trading days | item | 20 | ||||
Scenario, Plan | Convertible Notes | 8.2% Convertible Notes due 2022 | |||||
Debt Instrument | |||||
Convertible notes, converted amount | $ 71,400,000 |
Debt Obligations - 2022 Convert
Debt Obligations - 2022 Convertible Notes Components (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 | Feb. 29, 2016 |
Debt Instrument | |||
Convertible Notes | $ 81,359 | $ 79,885 | |
8.2% Convertible Notes due 2022 | |||
Debt Instrument | |||
Principal amount of the Convertible Notes | $ 100,000 | ||
8.2% Convertible Notes due 2022 | Convertible Notes | |||
Debt Instrument | |||
Principal amount of the Convertible Notes | 81,750 | 81,750 | $ 100,000 |
Unamortized debt discount and debt issuance costs | (391) | (1,865) | |
Convertible Notes | 81,359 | 79,885 | |
Total Convertible Notes | 108,479 | 106,513 | |
Related parties | 8.2% Convertible Notes due 2022 | Convertible Notes | |||
Debt Instrument | |||
Principal amount of the Convertible Notes | 27,250 | 27,250 | |
Unamortized debt discount and debt issuance costs | (130) | (622) | |
Convertible Notes | $ 27,120 | $ 26,628 |
Debt Obligations - 2022 Conve_2
Debt Obligations - 2022 Convertible Notes Interest Expense Components (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Debt Instrument | |||
Accretion of debt discount and debt issuance costs | $ 4,257 | $ 3,481 | $ 2,339 |
Total interest expense | 22,959 | 21,166 | 17,601 |
8.2% Convertible Notes due 2022 | Convertible Notes | |||
Debt Instrument | |||
Stated coupon interest | 6,150 | 6,150 | 6,150 |
Accretion of debt discount and debt issuance costs | 1,475 | 1,343 | 1,223 |
Interest expense | 7,625 | 7,493 | 7,373 |
Total interest expense | 10,166 | 9,991 | 9,830 |
1.5% Convertible Senior Subordinated Notes due 2026 | Convertible Notes | |||
Debt Instrument | |||
Stated coupon interest | 3,450 | 2,434 | |
Accretion of debt discount and debt issuance costs | 1,259 | 873 | |
Interest expense | 4,709 | 3,307 | |
Related parties | 8.2% Convertible Notes due 2022 | Convertible Notes | |||
Debt Instrument | |||
Stated coupon interest | 2,050 | 2,050 | 2,050 |
Accretion of debt discount and debt issuance costs | 491 | 448 | 407 |
Interest expense | $ 2,541 | $ 2,498 | $ 2,457 |
Debt Obligations - 2025 Term Lo
Debt Obligations - 2025 Term Loan Narrative (Details) - USD ($) $ in Thousands | Jan. 07, 2019 | Jan. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2019 | Dec. 31, 2020 | Jan. 01, 2020 | Feb. 29, 2016 |
Debt Instrument | |||||||
Payment of closing fee to the lenders in form of origination issue discount | $ 9,000 | ||||||
Minimum | |||||||
Debt Instrument | |||||||
Net sales | $ 250,000 | ||||||
2025 Term Loan | |||||||
Debt Instrument | |||||||
Aggregate principal amount | $ 75,000 | ||||||
Interest rate description | The Borrowings under the 2025 Term Loan bear interest through maturity at 7.00% per annum plus three month LIBOR. Pursuant to the terms of the 2025 Term Loan, the interest rate was reduced to 6.75% per annum plus LIBOR as of January 1, 2020 as the consolidated net sales for UDENYCA for the fiscal year ending December 31, 2019 were in excess of $250.0 million. Interest is payable quarterly in arrears. Under the prospective method to account for future cash payments adopted by the Company, the effective interest rate is not constant, and any change in the expected cash flows is recognized prospectively as an adjustment to the effective yield. As of December 31, 2021, the effective interest rate was 10.7%. | ||||||
Convertible notes, covenant compliance | The 2025 Term Loan contains certain affirmative covenants, negative covenants and events of default, including, covenants and restrictions that among other things, restrict the ability of the Company and its subsidiaries to, incur liens, incur additional indebtedness, make loans and investments, engage in mergers and acquisitions, in asset sales, and declare dividends or redeem or repurchase capital stock. Additionally, the consolidated net sales for UDENYCA must not be lower than $70.0 million for the fiscal year ending December 31, 2019, (b) $125.0 million for the fiscal year ending December 31, 2020, and (c) $150.0 million for each fiscal year thereafter. A failure to comply with these covenants could permit the Lender under the 2025 Term Loan to declare the Borrowings, together with accrued interest and fees, to be immediately due and payable. | ||||||
2025 Term Loan | Paid on or Prior to the Three Year Anniversary of Closing Date | |||||||
Debt Instrument | |||||||
Effective interest rate | 5.00% | ||||||
Prepayment premium, description | with respect to any prepayment paid or required to be paid on or prior to the three year anniversary of the Credit Agreement Closing Date, 5.00% of the Borrowings prepaid or required to be prepaid, plus all required interest payments that would have been due on the Borrowings prepaid or required to be prepaid through and including the three year anniversary of the 2025 Term Loan Closing Date | ||||||
2025 Term Loan | Paid after the Three Year but on or Prior to the Four Year Anniversary of Closing Date | |||||||
Debt Instrument | |||||||
Effective interest rate | 5.00% | ||||||
Prepayment premium, description | with respect to any prepayment paid or required to be paid after the three year anniversary of the 2025 Term Loan Closing Date but on or prior to the four year anniversary of the 2025 Term Loan Closing Date, 5.00% of the Borrowings prepaid or required to be prepaid | ||||||
2025 Term Loan | Paid after the Four Year but on or Prior to the Five Year Anniversary of Closing Date | |||||||
Debt Instrument | |||||||
Effective interest rate | 2.50% | ||||||
Prepayment premium, description | with respect to any prepayment paid or required to be paid after the four year anniversary of the 2025 Term Loan Closing Date but on or prior to the five year anniversary of the 2025 Term Loan Closing Date, 2.50% of the Borrowings prepaid or required to be prepaid | ||||||
2025 Term Loan | Paid Thereafter | |||||||
Debt Instrument | |||||||
Effective interest rate | 1.25% | ||||||
Prepayment premium, description | with respect to any prepayment paid or required to be prepaid thereafter, 1.25% of the Borrowings prepaid or required to be prepaid | ||||||
Lender | 2025 Term Loan | |||||||
Debt Instrument | |||||||
Total term of the loan | 6 years | ||||||
Aggregate principal amount | $ 75,000 | $ 75,000 | $ 75,000 | ||||
Effective interest rate | 10.70% | ||||||
Stated interest rate | 7.00% | 6.75% | |||||
Payment of closing fee to the lenders in form of origination issue discount | $ 1,100 | ||||||
Percentage required to pay an additional exit fee on principal amount | 4.00% | ||||||
Lender | 2025 Term Loan | Minimum | |||||||
Debt Instrument | |||||||
Consolidated net sales for UDENYCA minimum amount, 2019 | $ 70,000 | ||||||
Consolidated net sales for UDENYCA minimum amount, 2020 | 125,000 | ||||||
Consolidated net sales for UDENYCA minimum amount, thereafter | $ 150,000 | ||||||
Subsequent Event | 2025 Term Loan | |||||||
Debt Instrument | |||||||
Outstanding amount paid off | $ 81,900 |
Debt Obligations - 2025 Term _2
Debt Obligations - 2025 Term Loan Components (Details) - 2025 Term Loan - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 | Jan. 07, 2019 |
Debt Instrument | |||
Principal amount of the Term Loan | $ 75,000 | ||
Lender | |||
Debt Instrument | |||
Principal amount of the Term Loan | 75,000 | $ 75,000 | $ 75,000 |
Exit fee due on payment of 2025 Term Loan | 3,000 | 3,000 | |
2025 Term Loan, gross | 78,000 | 78,000 | |
Unamortized exit fee, debt discount and debt issuance costs, net | (2,487) | (3,519) | |
Net carrying amount of 2025 Convertible Notes | $ 75,513 | $ 74,481 |
Debt Obligations - 2025 Term _3
Debt Obligations - 2025 Term Loan Interest Expense Components (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Debt Instrument | |||
Accretion of debt discount and debt issuance costs | $ 4,257 | $ 3,481 | $ 2,339 |
Lender | 2025 Term Loan | |||
Debt Instrument | |||
Stated coupon interest | 7,034 | 7,053 | 7,063 |
Accretion of debt discount and debt issuance costs | 1,032 | 818 | 709 |
Interest expense | $ 8,066 | $ 7,871 | $ 7,772 |
Debt Obligations - 2025 Term _4
Debt Obligations - 2025 Term Loan Future Payments (Details) - Lender - 2025 Term Loan - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Debt Instrument | ||
Term Loan, gross | $ 78,000 | $ 78,000 |
Net carrying amount of 2025 Convertible Notes | 75,513 | $ 74,481 |
Scenario, Plan | ||
Debt Instrument | ||
2022 | 29,294 | |
2023 | 27,130 | |
2024 | 24,972 | |
2025 | 8,780 | |
Total minimum payments | 90,176 | |
Less amount representing interest | (12,176) | |
Term Loan, gross | 78,000 | |
Less debt discount and debt issuance costs on Convertible Notes | (2,487) | |
Net carrying amount of 2025 Convertible Notes | $ 75,513 |
Commitments and Contingencies -
Commitments and Contingencies - Schedule of Non-Cancelable Contractual Obligations (Details) $ in Thousands | Dec. 31, 2021USD ($) |
Commitments and Contingencies. | |
2022 | $ 27,052 |
2023 | 16,300 |
2024 | 10,108 |
2025 | 268 |
2026 | 179 |
Total obligations | $ 53,907 |
Leases - Additional Information
Leases - Additional Information (Details) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021USD ($)ft² | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($)item | |
Lessee Lease Description | |||
Term of leases | 36 months | ||
Operating lease costs | $ | $ 3.1 | $ 3.1 | $ 2.4 |
Cash paid for amounts included in measurement of lease liabilities | $ | $ 3.4 | $ 3.2 | |
Operating lease weighted average remaining term | 3 years 2 months 12 days | 4 years 1 month 6 days | |
Operating lease Weighted average discount rate | 8.00% | 8.10% | |
Finance lease weighted average remaining term | 1 year 8 months 12 days | 2 years 4 months 24 days | |
Finance lease Weighted average discount rate | 5.80% | 5.80% | |
Corporate Headquarters Lease | |||
Lessee Lease Description | |||
Area of office space leased | ft² | 47,789 | ||
Lease Expiration Date | Sep. 1, 2024 | ||
Option to extend lease | true | ||
Term of optional lease renewal | 5 years | ||
Laboratory Facilities Lease | |||
Lessee Lease Description | |||
Area of office space leased | ft² | 25,017 | ||
Term of optional lease renewal | 5 years | ||
New Camarillo Lease | |||
Lessee Lease Description | |||
Lease Expiration Date | May 1, 2027 | ||
Option to extend lease | true | ||
Vehicle Lease | |||
Lessee Lease Description | |||
Number of vehicles leased | item | 50 | ||
Term of leases | 36 months |
Leases - Schedule of Balance Sh
Leases - Schedule of Balance Sheet Classification of Lease Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Assets: | ||
Operating lease right-of-use assets | $ 8,193 | $ 9,956 |
Operating Lease, Right-of-Use Asset, Statement of Financial Position [Extensible List] | Other Assets Noncurrent | Other Assets Noncurrent |
Finance lease | $ 1,220 | $ 1,451 |
Finance Lease, Right-of-Use Asset, Statement of Financial Position [Extensible List] | Property, Plant and Equipment, Net | Property, Plant and Equipment, Net |
Total leased assets | $ 9,413 | $ 11,407 |
Liabilities: | ||
Lease liabilities, current | $ 2,751 | $ 2,573 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | Accrued Liabilities Current | Accrued Liabilities Current |
Operating lease liability noncurrent | $ 6,753 | $ 9,073 |
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | Operating and Finance Lease, Liability, Noncurrent | Operating and Finance Lease, Liability, Noncurrent |
Total operating lease liabilities | $ 9,504 | $ 11,646 |
Finance lease liabilities, current | $ 741 | $ 560 |
Finance Lease, Liability, Current, Statement of Financial Position [Extensible List] | Accrued Liabilities Current | Accrued Liabilities Current |
Finance lease liabilities, non-current | $ 498 | $ 875 |
Finance Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | Other Liabilities Noncurrent | Other Liabilities Noncurrent |
Total finance lease liabilities | $ 1,239 | $ 1,435 |
Leases - Schedule of Maturities
Leases - Schedule of Maturities of Operating and Finance Lease Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Operating leases | ||
2022 | $ 3,401 | |
2023 | 3,560 | |
2024 | 3,014 | |
2025 | 412 | |
2026 and beyond | 416 | |
Total lease payments | 10,803 | |
Less imputed interest | (1,299) | |
Total operating lease liabilities | 9,504 | $ 11,646 |
Finance leases | ||
2022 | 790 | |
2023 | 449 | |
2024 | 61 | |
Total lease payments | 1,300 | |
Less imputed interest | (61) | |
Total finance lease liabilities | $ 1,239 | $ 1,435 |
Stock-Based Compensation and _3
Stock-Based Compensation and Employee Benefits - Equity Incentive Plans Narrative (Details) | 12 Months Ended | 96 Months Ended |
Dec. 31, 2021shares | Dec. 31, 2021shares | |
2014 Plan | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Percentage of shares available for issuance | 4.00% | |
Common stock reserved for future issuance | 468,671 | 468,671 |
2010 Plan | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Awards issued | 0 | |
Common stock reserved for future issuance | 0 | 0 |
2016 Plan | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Common stock reserved for future issuance | 446,037 | 446,037 |
Stock-Based Compensation and _4
Stock-Based Compensation and Employee Benefits - Stock Options Narrative (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Feb. 28, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Options granted, weighted-average grant-date fair value | $ 9.80 | $ 10.94 | $ 9.52 | |
Options exercised, aggregate intrinsic value | $ 9,700 | $ 14,600 | $ 10,300 | |
Stock-based compensation expense | $ 800 | 51,364 | 38,160 | 33,591 |
Unrecognized stock-based compensation expenses related to stock options | $ 61,400 | |||
Unrecognized share-based compensation related to stock options, RSUs and ESPP, period for recognition | 2 years 7 months 6 days | |||
Employee Stock Option | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Vesting period | 4 years | |||
Options, expiration period | 10 years | |||
Stock-based compensation expense | $ 36,700 | 30,300 | 31,400 | |
Restricted Stock Units | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Stock-based compensation expense | 13,500 | $ 6,500 | $ 800 | |
Unrecognized stock-based compensation expenses related to stock options | $ 20,700 | |||
Unrecognized share-based compensation related to stock options, RSUs and ESPP, period for recognition | 1 year 9 months 18 days |
Stock Based Compensation and Em
Stock Based Compensation and Employee Benefits - Summary of Option Activities Under 2016 and 2014 Plans (Details) - 2016 plan and 2014 plan | 12 Months Ended |
Dec. 31, 2021$ / sharesshares | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Number of Options, Beginning balance | shares | 19,014,835 |
Number of Options, Granted - at fair value | shares | 4,559,125 |
Number of Options, Exercised | shares | (1,316,361) |
Number of Options, Forfeited/Canceled | shares | (2,297,784) |
Number of Options, Ending balance | shares | 19,959,815 |
Weighted-Average Exercise Price, Beginning balance | $ / shares | $ 15.41 |
Weighted-Average Exercise Price, Granted - at fair value | $ / shares | 16.62 |
Weighted Average Exercise Price, Exercised | $ / shares | 7.91 |
Weighted Average Exercise Price, Forfeited/Canceled | $ / shares | 17.96 |
Weighted-Average Exercise Price, Ending balance | $ / shares | $ 15.89 |
Stock-Based Compensation and _5
Stock-Based Compensation and Employee Benefits - Additional Information Related to Status of Options (Details) - 2016 plan and 2014 plan - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Options outstanding, Number of Options | 19,959,815 | 19,014,835 |
Options vested and exercisable, Number of Options | 13,453,683 | |
Options outstanding, Weighted-Average Exercise Price | $ 15.89 | $ 15.41 |
Options vested and exercisable, Weighted-Average Exercise Price | $ 15.56 | |
Options outstanding, Weighted-Average Remaining Contractual Terms | 6 years 4 months 24 days | |
Options vested and exercisable, Weighted-Average Remaining Contractual Terms | 5 years 4 months 24 days | |
Options outstanding, Aggregate Intrinsic Value | $ 47,892 | |
Options vested and exercisable, Aggregate Intrinsic Value | $ 43,291 |
Stock-Based Compensation and _6
Stock-Based Compensation and Employee Benefits - Summary of RSUs Activity, under 2014 Plan (Details) - Restricted Stock Units - $ / shares | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Number of RSUs, beginning balances | 1,009,657 | ||
Number of RSUs granted | 1,652,512 | ||
Number of RSUs vested | (465,930) | ||
Number of RSUs canceled | (352,507) | ||
Number of RSUs, ending balance | 1,843,732 | 1,009,657 | |
Weighted-Average Grant Date Fair Value, beginning balances | $ 17.91 | ||
Weighted-Average Grant Date Fair Value, RSUs granted | 16.86 | $ 17.86 | $ 15.11 |
Weighted-Average Grant Date Fair Value, RSUs Vested | 18.10 | ||
Weighted-Average Grant Date Fair Value, RSUs canceled | 17.54 | ||
Weighted-Average Grant Date Fair Value, ending balances | $ 17 | $ 17.91 |
Stock-Based Compensation and _7
Stock-Based Compensation and Employee Benefits - Restricted Stock Units narrative (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Feb. 28, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 800 | $ 51,364 | $ 38,160 | $ 33,591 |
Unrecognized share-based compensation related to stock options, RSUs and ESPP, period for recognition | 2 years 7 months 6 days | |||
Restricted Stock Units | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total fair value of RSUs vested | $ 8,400 | 4,100 | 2,700 | |
Total estimated grant date fair value | $ 27,900 | $ 21,200 | $ 4,300 | |
Estimated weighted-average grant-date fair value of RSUs granted | $ 16.86 | $ 17.86 | $ 15.11 | |
Stock-based compensation expense | $ 13,500 | $ 6,500 | $ 800 | |
Unrecognized share-based compensation related to stock options, RSUs and ESPP, period for recognition | 1 year 9 months 18 days | |||
Restricted Stock Units | Minimum | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Vesting period | 1 year | |||
Restricted Stock Units | Maximum | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Vesting period | 3 years |
Stock-Based Compensation and _8
Stock-Based Compensation and Employee Benefits - Employee Stock Purchase Plan (Details) - USD ($) $ in Thousands | Oct. 31, 2014 | Feb. 28, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Stock-based compensation expense | $ 800 | $ 51,364 | $ 38,160 | $ 33,591 | |
Unrecognized stock-based compensation expenses related to stock options | $ 61,400 | ||||
Unrecognized share-based compensation related to stock options, RSUs and ESPP, period for recognition | 2 years 7 months 6 days | ||||
2014 Employee Stock Purchase Plan (ESPP) | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Common stock reserved for future issuance | 3,238,648 | ||||
Percentage of purchase common stock of lesser of fair market value of common stock on first or last day of offering period by eligible employees | 85.00% | ||||
Employee stock purchase plan offering period one | --05-16 | ||||
Employee stock purchase plan offering period two | --11-16 | ||||
Stock-based compensation expense | $ 1,200 | $ 1,400 | $ 1,300 | ||
Unrecognized stock-based compensation expenses related to stock options | $ 600 | ||||
Unrecognized share-based compensation related to stock options, RSUs and ESPP, period for recognition | 4 months 15 days | ||||
2014 Employee Stock Purchase Plan (ESPP) | Minimum | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Percentage of shares reserve for issuance | 1.00% |
Stock-Based Compensation and _9
Stock-Based Compensation and Employee Benefits - Stock-Based Compensation (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Feb. 28, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs | ||||
Stock-based compensation expense | $ 800 | $ 51,364 | $ 38,160 | $ 33,591 |
Capitalized stock-based compensation expense into inventory | 1,025 | 1,460 | 1,735 | |
Cost of Goods Sold | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs | ||||
Stock-based compensation expense | 1,099 | 583 | 108 | |
Research and Development Expense | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs | ||||
Stock-based compensation expense | 18,688 | 13,837 | 12,912 | |
Selling, General and Administrative Expenses | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs | ||||
Stock-based compensation expense | $ 31,577 | $ 23,740 | $ 20,571 |
Stock-Based Compensation and_10
Stock-Based Compensation and Employee Benefits - Valuation Assumptions (Details) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Expected dividend yield | 0.00% | ||
2014 Employee Stock Purchase Plan (ESPP) | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Expected term (years) | 6 months | 6 months | 6 months |
Expected volatility | 42.00% | 58.00% | 61.00% |
Risk-free interest rate | 0.06% | 0.13% | 1.89% |
Employee Stock Option | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Expected term (years) | 6 years 29 days | 6 years 1 month 6 days | 6 years |
Expected volatility | 65.00% | 68.00% | 69.00% |
Risk-free interest rate | 0.89% | 1.09% | 2.29% |
Stock-Based Compensation and_11
Stock-Based Compensation and Employee Benefits - 401(k) Retirement Plan (Details) - 401(k) Plan - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Percentage of maximum contribution of annual compensation | 100.00% | 50.00% | 50.00% |
First amount of each participant's contributions | $ 7,500 | $ 6,000 | $ 6,000 |
Compensation expense related to match plan | $ 1,700,000 | $ 800,000 | $ 800,000 |
Maximum | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Percentage of maximum contribution of annual compensation | 90.00% | ||
Percentage of employer matching contributions | 4.00% |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Operating Loss Carryforwards [Line Items] | ||||
Income tax provision | $ 0 | $ 3,463 | $ 2,942 | |
Increase (decrease) in valuation allowance | 72,400 | (22,700) | (13,400) | |
Unrecognized tax benefits, accrued interest and penalties accrued | 0 | 0 | 0 | |
Unrecognized Tax Benefits | 15,495 | $ 13,243 | $ 11,603 | $ 18,115 |
Federal | ||||
Operating Loss Carryforwards [Line Items] | ||||
Net operating loss carryforwards | $ 533,500 | |||
Net operating loss carryforwards expiration year | 2036 | |||
Tax credit carryforwards | $ 54,000 | |||
Tax credit carryforwards expiration year | 2031 | |||
Various states | ||||
Operating Loss Carryforwards [Line Items] | ||||
Net operating loss carryforwards | $ 83,700 | |||
Net operating loss carryforwards expiration year | 2031 | |||
Tax credit carryforwards | $ 23,500 |
Income Taxes - Components of In
Income Taxes - Components of Income (Loss) Before Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Components of income (loss) before income taxes | |||
Domestic | $ (287,058) | $ 133,615 | $ 92,585 |
Foreign | (42) | 2,092 | 190 |
Net (loss) income before income taxes | $ (287,100) | $ 135,707 | $ 92,775 |
Income Taxes - Provision for In
Income Taxes - Provision for Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Current | |||
State | $ 3,463 | $ 2,942 | |
Subtotal | 3,463 | 2,942 | |
Deferred | |||
Provision for income taxes | $ 0 | $ 3,463 | $ 2,942 |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Statutory U.S. Federal Rate (Details) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Percent of pre-tax income: | |||
United States federal statutory income tax rate | 21.00% | 21.00% | 21.00% |
State taxes, net of federal benefit | 2.60% | 2.00% | 1.50% |
Foreign rate differences | 0.00% | (0.30%) | (0.10%) |
Permanent items | 0.20% | 0.40% | (0.60%) |
Research and development credit | 2.60% | (4.80%) | (4.80%) |
Stock based compensation costs | (1.20%) | 1.30% | 1.30% |
Other | 0.00% | (0.30%) | (0.70%) |
Change in valuation allowance | (25.20%) | (16.70%) | (14.40%) |
Effective income tax rate | 0.00% | 2.60% | 3.20% |
Income Taxes - Components of Ne
Income Taxes - Components of Net Deferred Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Components Of Deferred Tax Assets [Abstract] | ||
Net operating loss carryforwards | $ 117,793 | $ 94,043 |
Research and development credits | 58,039 | 49,965 |
Depreciation and amortization | 40,620 | 9,672 |
Stock-based compensation | 30,565 | 25,983 |
Sales related accruals | 17,299 | 16,404 |
Other accruals | 11,798 | 8,013 |
Gross deferred tax assets | 276,114 | 204,080 |
Right-of-use asset | (2,167) | (2,566) |
In-process research and development | (603) | (589) |
Gross deferred tax liabilities | (2,770) | (3,155) |
Total net deferred tax asset | 273,344 | 200,925 |
Less valuation allowance | $ (273,344) | $ (200,925) |
Income Taxes - Reconciliation_2
Income Taxes - Reconciliation of Unrecognized Tax Benefits (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Reconciliation Of Unrecognized Tax Benefits Excluding Amounts Pertaining To Examined Tax Returns Roll Forward | |||
Balance at beginning of year | $ 13,243 | $ 11,603 | $ 18,115 |
Additions based on tax positions related to current year | 2,038 | 1,749 | 1,206 |
Additions (reductions) for tax positions of prior years | 214 | (109) | (7,718) |
Balance at end of year | $ 15,495 | $ 13,243 | $ 11,603 |
Net (Loss) Income Per Share - C
Net (Loss) Income Per Share - Computation of Basic and Diluted Net Income Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Numerator: | |||
Net (loss) income | $ (287,100) | $ 132,244 | $ 89,833 |
Denominator: | |||
Weighted-average common shares outstanding | 75,449,632 | 71,411,705 | 69,679,916 |
Basic net (loss) income per share | $ (3.81) | $ 1.85 | $ 1.29 |
Numerator: | |||
Net (loss) income | $ (287,100) | $ 132,244 | $ 89,833 |
Add interest expense on 2026 Convertible Notes, net of tax | 3,307 | ||
Numerator for diluted net (loss) income per share | $ (287,100) | $ 135,551 | $ 89,833 |
Denominator: | |||
Denominator for basic net (loss) income per share | 75,449,632 | 71,411,705 | 69,679,916 |
Add effect of potential dilutive securities: | |||
Stock options, including shares subject to ESPP | 3,455,646 | 3,491,272 | |
Restricted stock units | 167,597 | 14,755 | |
Shares issuable upon conversion of convertible notes | 8,456,950 | ||
Denominator for diluted net (loss) income per share | 75,449,632 | 83,491,898 | 73,185,943 |
Diluted net (loss) income per share | $ (3.81) | $ 1.62 | $ 1.23 |
Net (Loss) Income Per Share - O
Net (Loss) Income Per Share - Outstanding Dilutive Potential Shares Excluded from Calculation of Diluted Net (loss) Income Per Share (Details) - shares | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Antidilutive securities excluded from computation of EPS | |||
Antidilutive securities excluded from the calculation of diluted net (loss) income per share | 38,122,727 | 14,002,963 | 14,908,410 |
Stock options, including shares subject to ESPP | |||
Antidilutive securities excluded from computation of EPS | |||
Antidilutive securities excluded from the calculation of diluted net (loss) income per share | 19,895,097 | 9,521,403 | 10,412,471 |
Restricted Stock Units | |||
Antidilutive securities excluded from computation of EPS | |||
Antidilutive securities excluded from the calculation of diluted net (loss) income per share | 1,811,607 | 7,689 | 22,068 |
8.2% Convertible Notes due 2022 | Shares Issuable Upon Conversion of Convertible Notes | |||
Antidilutive securities excluded from computation of EPS | |||
Antidilutive securities excluded from the calculation of diluted net (loss) income per share | 4,473,871 | 4,473,871 | 4,473,871 |
1.5% Convertible Senior Subordinated Notes due 2026 | Shares Issuable Upon Conversion of Convertible Notes | |||
Antidilutive securities excluded from computation of EPS | |||
Antidilutive securities excluded from the calculation of diluted net (loss) income per share | 11,942,152 |
Related Party Transactions (Det
Related Party Transactions (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | |||
Feb. 28, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Feb. 29, 2016 | |
Related Party Transaction | |||||
Stock-based compensation expense | $ 800 | $ 51,364 | $ 38,160 | $ 33,591 | |
Consulting Agreement With Lanfear Advisors | |||||
Related Party Transaction | |||||
Number of options, granted | 65,000 | ||||
Exercise price | $ 17.60 | ||||
Cash consulting expense | 200 | 300 | |||
Liabilities recognized | $ 0 | $ 300 | |||
8.2% Convertible Notes due 2022 | |||||
Related Party Transaction | |||||
Aggregate principal amount | $ 100,000 | ||||
8.2% Convertible Notes due 2022 | Board of Directors | |||||
Related Party Transaction | |||||
Aggregate principal amount | $ 25,000 |
Subsequent Events - 2027 Term L
Subsequent Events - 2027 Term Loans and TIGIT Option Exercises (Details) - USD ($) $ in Millions | Jan. 09, 2022 | Jan. 31, 2022 | Dec. 31, 2021 | Apr. 30, 2020 | Feb. 29, 2016 |
Subsequent Event [Line Items] | |||||
Debt Instrument, Fee Amount | $ 9 | ||||
8.2% Convertible Notes due 2022 | |||||
Subsequent Event [Line Items] | |||||
Debt Instrument Face Amount | $ 100 | ||||
Stated interest rate | 8.20% | ||||
1.5% Convertible Senior Subordinated Notes due 2026 | |||||
Subsequent Event [Line Items] | |||||
Debt Instrument Face Amount | $ 230 | ||||
Stated interest rate | 1.50% | ||||
2025 Term Loan | |||||
Subsequent Event [Line Items] | |||||
Debt Instrument Face Amount | $ 75 | ||||
Subsequent Event | TIGIT Exercise Letter Agreement | Junshi Biosciences | |||||
Subsequent Event [Line Items] | |||||
Option Exercise Fess | $ 35 | ||||
Option Exercise Payment, Required Term | 10 days | ||||
Maximum aggregate milestone payments | $ 255 | ||||
Collaboration agreement, royalty on net sales, percentage | 18.00% | ||||
Subsequent Event | 2025 Term Loan | |||||
Subsequent Event [Line Items] | |||||
Outstanding amount paid off | $ 81.9 | ||||
Subsequent Event | 2027 Term Loans | |||||
Subsequent Event [Line Items] | |||||
Debt Instrument Face Amount | $ 400 | ||||
Stated interest rate | 8.25% | ||||
Loan Agreement, Funding Fee, Percentage | 2.00% | ||||
Loan agreement covenants, minimum trailing twelve month net sales for current quarter | $ 200 | ||||
Loan agreement covenants, minimum trailing twelve month net sales for the quarter ended March 30, 2024 | 210 | ||||
Loan agreement covenants, minimum trailing twelve-month net sales for the quarter ended December 31, 2024 | $ 300 | ||||
Mandatory Prepayment, Term | 10 days | ||||
Subsequent Event | 2027 Term Loans | Additional facility amount | |||||
Subsequent Event [Line Items] | |||||
Debt Instrument Face Amount | $ 100 | ||||
Subsequent Event | 2027 Term Loans | Three-month LIBOR | |||||
Subsequent Event [Line Items] | |||||
Debt Instrument, Basis Spread on Variable Rate | 1.00% | ||||
Subsequent Event | Tranche A Loan, funded January 5, 2022 | |||||
Subsequent Event [Line Items] | |||||
Debt Instrument Face Amount | $ 100 | ||||
Loan Agreement, Prepayment Fee, Percentage | 3.00% | ||||
Subsequent Event | Tranche A Loan, Third Anniversary, funded January 5, 2022 | |||||
Subsequent Event [Line Items] | |||||
Loan Agreement, Prepayment Fee, Percentage | 2.00% | ||||
Subsequent Event | Tranche B Loan, funded no later than April 1, 2022 | |||||
Subsequent Event [Line Items] | |||||
Debt Instrument Face Amount | $ 100 | ||||
Loan Agreement, Prepayment Fee, Percentage | 1.00% | ||||
Subsequent Event | Tranche C Loan, funded between April 1, 2022 and March 17, 2023 | |||||
Subsequent Event [Line Items] | |||||
Debt Instrument Face Amount | $ 50 | ||||
Subsequent Event | Tranche D Loan, funded between April 1, 2022 and March 17, 2023 | |||||
Subsequent Event [Line Items] | |||||
Debt Instrument Face Amount | 50 | ||||
Subsequent Event | 2025 Term Loan | 2025 Term Loan | |||||
Subsequent Event [Line Items] | |||||
Outstanding amount paid off | 81.9 | ||||
Subsequent Event | Scenario, Plan | Minimum | 1.5% Convertible Senior Subordinated Notes due 2026 | |||||
Subsequent Event [Line Items] | |||||
Debt Instrument Face Amount | $ 50 |