Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Feb. 28, 2023 | Jun. 30, 2022 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Document Period End Date | Dec. 31, 2022 | ||
Documents Incorporated by Reference | Part III incorporates by reference certain information from the registrant’s definitive proxy statement for the 2023 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 | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Accelerated Filer | ||
ICFR Auditor Attestation Flag | true | ||
Auditor Name | Ernst & Young LLP | ||
Auditor Firm ID | 42 | ||
Auditor Location | San Mateo, California | ||
Entity Small Business | false | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Common Stock, Shares Outstanding | 79,609,789 | ||
Entity Public Float | $ 443,562,973 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2022 | ||
Document Fiscal Period Focus | FY | ||
Entity Central Index Key | 0001512762 | ||
Amendment Flag | false |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 63,547 | $ 417,195 |
Investments in marketable securities | 128,134 | |
Trade receivables, net | 109,964 | 123,022 |
Inventory | 38,791 | 37,642 |
Prepaid manufacturing | 17,880 | 13,666 |
Other prepaids and current assets | 22,918 | 10,798 |
Total current assets | 381,234 | 602,323 |
Property and equipment, net | 8,754 | 7,813 |
Inventory, non-current | 76,260 | 55,610 |
Goodwill and intangible assets | 5,931 | 3,563 |
Other assets, non-current | 8,668 | 10,025 |
Total assets | 480,847 | 679,334 |
Current liabilities: | ||
Accounts payable | 11,526 | 16,159 |
Accrued rebates, fees and reserves | 54,461 | 79,027 |
Accrued compensation | 22,610 | 22,014 |
Accrued and other current liabilities | 50,097 | 48,127 |
Total current liabilities | 138,694 | 165,327 |
Term loans | 245,483 | 75,513 |
Convertible notes | 225,575 | 332,767 |
Lease liabilities, non-current | 5,046 | 7,251 |
Other liabilities, non-current | 3,467 | 750 |
Total liabilities | 618,265 | 581,608 |
Commitments and contingencies (Note 8) | ||
Stockholders' equity (deficit): | ||
Common stock ($0.0001 par value; shares authorized: 300,000,000; shares issued and outstanding: 78,851,516 and 76,930,096 at December 31, 2022 and 2021, respectively) | 8 | 7 |
Additional paid-in capital | 1,204,431 | 1,147,843 |
Accumulated other comprehensive loss | (249) | (270) |
Accumulated deficit | (1,341,608) | (1,049,854) |
Total stockholders' equity (deficit) | (137,418) | 97,726 |
Total liabilities and stockholders' equity (deficit) | $ 480,847 | $ 679,334 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parentheticals) - $ / shares | Dec. 31, 2022 | Dec. 31, 2021 |
Consolidated Balance Sheets | ||
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 300,000,000 | 300,000,000 |
Common stock, shares issued | 78,851,516 | 76,930,096 |
Common stock, shares outstanding | 78,851,516 | 76,930,096 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Revenue: | |||
Net revenue | $ 211,042 | $ 326,551 | $ 475,824 |
Costs and expenses: | |||
Cost of goods sold | 70,083 | 57,591 | 37,667 |
Research and development | 199,358 | 363,105 | 142,759 |
Selling, general and administrative | 198,481 | 169,713 | 139,079 |
Total costs and expenses | 467,922 | 590,409 | 319,505 |
(Loss) income from operations | (256,880) | (263,858) | 156,319 |
Interest expense | (32,474) | (22,959) | (21,166) |
Loss on debt extinguishment | (6,222) | ||
Other income (expense), net | 3,822 | (283) | 554 |
(Loss) income before income taxes | (291,754) | (287,100) | 135,707 |
Income tax provision | 0 | 0 | 3,463 |
Net (loss) income | $ (291,754) | $ (287,100) | $ 132,244 |
Net (loss) income per share: | |||
Basic (In dollar per share) | $ (3.76) | $ (3.81) | $ 1.85 |
Diluted (In dollar per share) | $ (3.76) | $ (3.81) | $ 1.62 |
Weighted-average number of shares used in computing basic and diluted net (loss) income per share: | |||
Basic (In shares) | 77,630,020 | 75,449,632 | 71,411,705 |
Diluted (In shares) | 77,630,020 | 75,449,632 | 83,491,898 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive (Loss) Income - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Consolidated Statements of Comprehensive (Loss) Income | |||
Net (loss) income | $ (291,754) | $ (287,100) | $ 132,244 |
Other comprehensive (loss) income: | |||
Unrealized gain on available-for-sale securities, net of tax | 22 | ||
Foreign currency translation adjustments, net of tax | (1) | 288 | |
Comprehensive (loss) income | $ (291,733) | $ (287,100) | $ 132,532 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity (Deficit) - USD ($) $ in Thousands | 2019 bonus payout in RSUs Common Stock | 2019 bonus payout in RSUs Additional Paid-In Capital | 2019 bonus payout in RSUs | Common Stock At The Market Offering. | Common Stock | Additional Paid-In Capital At The Market Offering. | Additional Paid-In Capital | Accumulated Other Comprehensive Loss Cumulative translation adjustment | Accumulated Other Comprehensive Loss | Accumulated Deficit | Cumulative translation adjustment | At The Market Offering. | Total |
Beginning Balances at Dec. 31, 2019 | $ 7 | $ 1,000,763 | $ (558) | $ (894,998) | $ 105,214 | ||||||||
Beginning Balances (in shares) at Dec. 31, 2019 | 70,366,661 | ||||||||||||
Net loss | 132,244 | 132,244 | |||||||||||
Issuance of common stock upon exercise of stock options | 17,061 | 17,061 | |||||||||||
Issuance of common stock upon exercise of stock options (in shares) | 1,704,764 | ||||||||||||
Issuance of common stock upon vesting of RSUs | $ 2,378 | $ 2,378 | |||||||||||
Issuance of common stock upon vesting of RSUs (in shares) | 134,099 | 89,668 | |||||||||||
Stock-based compensation expense | 39,038 | 39,038 | |||||||||||
Issuance of common stock under the ESPP | 3,801 | 3,801 | |||||||||||
Issuance of common stock under the ESPP (in shares) | 267,772 | ||||||||||||
Taxes paid related to net share settlement of RSUs | (880) | (880) | |||||||||||
Taxes paid related to net share settlement of RSUs (in shares) | (49,616) | ||||||||||||
Purchase of capped call options related to convertible notes due 2026 | 18,170 | 18,170 | |||||||||||
Cumulative translation adjustment | $ 288 | $ 288 | 288 | ||||||||||
Ending Balances at Dec. 31, 2020 | $ 7 | 1,043,991 | (270) | (762,754) | 280,974 | ||||||||
Ending Balances (in shares) at Dec. 31, 2020 | 72,513,348 | ||||||||||||
Net loss | (287,100) | (287,100) | |||||||||||
Issuance of common stock upon exercise of stock options | 10,410 | 10,410 | |||||||||||
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 | 51,290 | |||||||||||
Issuance of common stock to Shanghai Junshi Biosciences Ltd. ("Junshi Biosciences"), net of issuance costs | 40,903 | 40,903 | |||||||||||
Issuance of common stock to Shanghai Junshi Biosciences Ltd. ("Junshi Biosciences"), net of issuance costs (in shares) | 2,491,988 | ||||||||||||
Issuance of common stock under the ESPP | 3,002 | 3,002 | |||||||||||
Issuance of common stock under the ESPP (in shares) | 238,934 | ||||||||||||
Stock Issued During Period Value New Issues | 40,903 | 40,903 | |||||||||||
Taxes paid related to net share settlement of RSUs | (1,753) | (1,753) | |||||||||||
Taxes paid related to net share settlement of RSUs (in shares) | (96,465) | ||||||||||||
Ending Balances at Dec. 31, 2021 | $ 7 | 1,147,843 | (270) | (1,049,854) | $ 97,726 | ||||||||
Ending Balances (in shares) at Dec. 31, 2021 | 76,930,096 | 76,930,096 | |||||||||||
Net loss | (291,754) | $ (291,754) | |||||||||||
Issuance of common stock upon exercise of stock options | 691 | 691 | |||||||||||
Issuance of common stock upon exercise of stock options (in shares) | 141,897 | ||||||||||||
Issuance of common stock upon vesting of RSUs (in shares) | 806,854 | ||||||||||||
Stock-based compensation expense | 51,188 | 51,188 | |||||||||||
Issuance of common stock under ATM Offering, net of issuance costs | $ 1 | $ 6,133 | $ 6,134 | ||||||||||
Issuance of common stock to Shanghai Junshi Biosciences Ltd. ("Junshi Biosciences"), net of issuance costs (in shares) | 916,884 | 916,884 | |||||||||||
Issuance of common stock under the ESPP | 2,320 | 2,320 | |||||||||||
Issuance of common stock under the ESPP (in shares) | 347,883 | ||||||||||||
Taxes paid related to net share settlement of RSUs | (3,744) | (3,744) | |||||||||||
Taxes paid related to net share settlement of RSUs (in shares) | (292,098) | ||||||||||||
Other comprehensive gain (loss), net of tax | 21 | 21 | |||||||||||
Cumulative translation adjustment | (1) | ||||||||||||
Ending Balances at Dec. 31, 2022 | $ 8 | $ 1,204,431 | $ (249) | $ (1,341,608) | $ (137,418) | ||||||||
Ending Balances (in shares) at Dec. 31, 2022 | 78,851,516 | 78,851,516 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Operating activities | |||
Net (loss) income | $ (291,754) | $ (287,100) | $ 132,244 |
Adjustments to reconcile net (loss) income to net cash (used in) provided by operating activities: | |||
Depreciation and amortization | 3,699 | 3,454 | 2,888 |
Stock-based compensation expense | 50,737 | 51,364 | 38,160 |
Write-off of prepaid manufacturing services related to the termination of CHS-2020 | 3,210 | ||
Inventory write-offs, net | 26,000 | 5,133 | 2,171 |
Non-cash interest expense from amortization of debt discount & issuance costs | 6,431 | 4,257 | 3,481 |
Upfront and option payments to Junshi Biosciences | 35,000 | 136,000 | |
Other upfront and milestone based license fee payments | 7,500 | ||
Loss on debt extinguishment | 6,222 | ||
Other non-cash adjustments, net | 1,798 | 3,890 | 2,352 |
Changes in operating assets and liabilities: | |||
Trade receivables, net | 13,052 | 34,062 | (15,218) |
Inventory | (47,348) | (6,253) | (38,359) |
Prepaid manufacturing | (4,214) | 3,828 | (10,851) |
Other prepaid, current and non-current assets | (13,424) | (5,351) | (2,020) |
Accounts payable | (4,548) | 874 | (9,820) |
Accrued rebates, fees and reserves | (24,566) | (2,502) | 30,409 |
Accrued compensation | 596 | (230) | 6,212 |
Accrued and other current and non-current liabilities | 1,195 | 17,932 | 4,996 |
Net cash (used in) provided by operating activities | (241,124) | (37,432) | 154,145 |
Investing activities | |||
Purchases of property and equipment | (2,039) | (1,289) | (7,231) |
Proceeds from disposal of property and equipment | 175 | ||
Purchases of investments in marketable securities | (127,382) | (182,485) | (273,845) |
Proceeds from maturities of investments in marketable securities | 99,692 | 274,000 | |
Proceeds from sale of investments in marketable securities | 81,672 | ||
Upfront and option payments to Junshi Biosciences | (35,000) | (136,000) | |
Other upfront and milestone based license fee payments | (2,429) | (7,500) | |
Net cash used in investing activities | (166,850) | (138,410) | (14,401) |
Financing activities | |||
Proceeds from issuance of 2026 Convertible Notes, net of issuance costs | 222,156 | ||
Proceeds from 2027 Term Loans, net of debt discount & issuance costs | 240,679 | ||
Proceeds from issuance of common stock to Junshi Biosciences, net of issuance costs | 40,903 | ||
Proceeds from issuance of common stock under ATM Offering, net of issuance costs | 6,358 | ||
Proceeds from issuance of common stock upon exercise of stock options | 691 | 10,399 | 17,428 |
Proceeds from purchase under the employee stock purchase plan | 2,320 | 3,002 | 3,801 |
Purchase of capped call options related to 2026 Convertible Notes | (18,170) | ||
Taxes paid related to net share settlement of RSUs | (3,744) | (1,753) | (880) |
Repayment of 2022 Convertible Notes and premiums | (109,000) | ||
Repayment of 2025 Term Loan, premiums and exit fees | (81,750) | ||
Other financing activities | (1,228) | (672) | (389) |
Net cash provided by financing activities | 54,326 | 51,879 | 223,946 |
Net (decrease) increase in cash, cash equivalents and restricted cash | (353,648) | (123,963) | 363,690 |
Cash, cash equivalents and restricted cash at beginning of period | 417,635 | 541,598 | 177,908 |
Cash, cash equivalents and restricted cash at end of period | 63,987 | 417,635 | 541,598 |
Supplemental disclosure of cash flow information | |||
Cash paid for interest | 34,878 | 18,684 | 16,959 |
Cash paid for income taxes | 40 | 1,221 | 3,953 |
Right-of-use assets obtained in exchange for lease obligations related to operating leases | 434 | 1,388 | |
Right-of-use assets obtained in exchange for lease obligations related to finance leases | 2,694 | 477 | 1,817 |
Supplemental disclosures of non-cash investing and financing activities | |||
Purchase of property and equipment in accounts payable and accrued liabilities | $ 32 | $ 119 | 109 |
Non-cash employee bonuses settled in common stock | $ 1,498 |
Organization and Significant Ac
Organization and Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2022 | |
Organization and Significant Accounting Policies | |
Organization and 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 cancer treatments and commercialization of its portfolio of FDA-approved biosimilars. 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 (pegfilgrastim-cbqv) (adalimumab-aqvh), a biosimilar to Humira, (ranibizumab-eqrn) The Company’s product pipeline comprises the following three product candidates: toripalimab, an anti-PD-1 antibody being developed in collaboration with Junshi Biosciences; CHS-006, an antibody targeting TIGIT being developed in collaboration with Junshi Biosciences; and one wholly-owned preclinical immuno-oncology program, CHS-1000, an antibody targeting ILT4. In May 2022, the Company discontinued development of its bevacizumab (Avastin) biosimilar product candidate in-licensed from Innovent. In October 2022, the Company discontinued development of its preclinical immuno-oncology program, CHS-3318, an antibody targeting CCR8. On January 9, 2023, the Company announced that it entered into the Term Sheet with Klinge Biopharma for the exclusive commercialization rights to FYB203, a biosimilar candidate to Eylea® (aflibercept), in the United States. The parties to the Term Sheet expect to execute the Definitive Agreements contemplated by the Term Sheet and complete the transaction in the first half of 2023. 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 COVID-19 outbreaks 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, as the chief operating decision maker (“CODM”), manages and allocates resources to the operations of the Company on an entity-wide basis. Managing and allocating resources on an entity-wide basis enables the CODM to assess the overall level of resources available and how to best deploy these resources across functions. Primarily, all revenue is generated and all long-lived assets are 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: (in thousands) January 1, At beginning of period: 2022 2021 2020 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 December 31, At end of period: 2022 2021 2020 Cash and cash equivalents $ 63,547 $ 417,195 $ 541,158 Restricted cash 440 440 440 Total cash, cash equivalents and restricted cash $ 63,987 $ 417,635 $ 541,598 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 in 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 U.S. Treasury securities, commercial paper, corporate debt obligations and short-term money market instruments. 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 limits its exposure to any single issuer, except for securities issued by the U.S. government. 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 regularly reviews its investments for declines in fair value below the amortized cost basis to determine whether the impairment, if any, is due to credit-related or other factors. This review includes the credit worthiness of the security issuers, the severity of the unrealized losses, whether the Company has the intent to sell the securities and whether it is more likely than not that the Company will be required to sell the securities before the recovery of the amortized cost basis. Unrealized gains and losses on available-for-sale debt 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 available-for-sale debt 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. There were no impairments related to credit losses during any of the periods presented. Realized gains and losses, if any, on available-for-sale securities are included in other income (expense), net, in the consolidated statements of operations based on the specific identification method. During 2022, 2021 and 2020, interest income from marketable securities was $1.9 million, $1.4 million and $0.6 million, respectively, and is included in other income (expense), net, in the consolidated statements of operations. 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 and was not material during the periods presented. The Company believes that its allowance for expected credit losses was adequate and immaterial as of December 31, 2022 and 2021. Concentrations of Risk The Company’s financial instruments that are exposed to concentration of credit risk consist primarily of cash, cash equivalents, investments in marketable securities and trade receivables. The Company attempts to minimize the risks related to cash, cash equivalents and marketable securities 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. The Company 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. Substantially all of the Company’s revenues are in the United States to three wholesalers. UDENYCA and CIMERLI were the only products sold by the Company during 2022. UDENYCA was the only product sold and accounted for all of the Company’s revenues in 2021 and 2020. The Company enters into a strategic commercial supply agreement for each of its products. The Company currently has not engaged back-up suppliers or vendors. If any of the Company’s current vendors are 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. Foreign Currency Assets and liabilities denominated in foreign currency are remeasured at period-end exchange rates for monetary assets and liabilities. Non-monetary assets and liabilities denominated in foreign currencies are remeasured at historical rates. Translation gains and losses are included in accumulated other comprehensive loss in stockholders’ equity (deficit). Revenue and expense accounts are translated to U.S. dollars at average exchange rates in effect during the period with resulting transaction gains and losses recognized in other income (expense), net in the consolidated statements of operations. 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. During the third quarter of 2022, the Company recorded a $26.0 million write-down of inventory in cost of goods sold in the consolidated statements of operations due to the competitive environment and lower demand for UDENYCA resulting in certain inventory becoming at risk of expiration. For 2022, this increased the net loss by $26.0 million and basic and diluted net loss per share by $0.33. 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 product candidates, the Company incurred expenses for the manufacture of drug product that could potentially be available to support the commercial launch of the 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. Inventory in the consolidated balance sheets as of December 31, 2022 was related to UDENYCA, YUSIMRY and CIMERLI. 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 fair value of net assets acquired in a business combination. Goodwill is not amortized but is evaluated for impairment on an annual basis, during the fourth quarter, or more frequently if an event occurs or circumstances change that would more-likely-than-not reduce the fair value of the Company’s single reporting unit below its carrying amount. The Company’s goodwill balance was $0.9 million as of December 31, 2022 and 2021, and no goodwill impairment charges were recognized in 2022, 2021 or 2020. Acquired in-process research and development (“IPR&D”) that the Company acquires in conjunction with the acquisition of a business represents the fair value assigned to incomplete research projects which, at the time of acquisition, have not reached technological feasibility. The amounts are capitalized and are accounted for as indefinite-lived intangible assets, subject to impairment testing until completion or abandonment of the projects. Upon successful completion of each IPR&D project, the Company will make a determination as to the then-useful life of the intangible asset, generally determined by the period in which the substantial majority of the cash flows are expected to be generated, and begin amortization. The Company evaluates IPR&D for impairment on an annual basis, during the fourth quarter, or more frequently if impairment indicators exist. The Company’s IPR&D balance was $2.6 million as of December 31, 2022 and 2021, and no IPR&D impairment charges were recognized in 2022, 2021 or 2020. As of December 31, 2022, the Company had a $2.4 million definite-lived intangible asset, net related to a 2022 capitalized milestone payment under a license agreement. This is amortized on a straight-line basis over its estimated economic life of ten years and is reviewed periodically for impairment. Amortization expense is recorded as a component of cost of goods sold in the consolidated statements of operations and was immaterial in 2022. 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, 2022, 2021 and 2020. 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 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 approximately 90 days from date of shipment and may be extended during the launch period of a new product. 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: are classified in selling, general and administrative expense in the Company’s consolidated statements of operations, otherwise they are included as a reduction in product revenue. 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 all periods presented and is included in net revenue. Cost of Goods Sold Cost of goods sold consists primarily of third-party manufacturing, distribution, and certain overhead costs. Through March 31, 2021, a portion of the costs of producing UDENYCA sold was expensed as research and development before the FDA approval of UDENYCA and therefore is not reflected in cost of goods sold. All the inventory expensed prior to approval of UDENYCA was fully utilized by March 31, 2021; thus, the costs of producing UDENYCA are fully reflected in cost of goods sold beginning April 1, 2021. 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. Additionally, the Company shares 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. In 2022, 2021 and 2020, cost of goods sold included inventory write-offs, net of $26.0 million, $5.1 million and $2.2 million, respectively. Research and Development Expense Research and development expense represents costs incurred to conduct research, such as the discovery and development of 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 collaborators, 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, analytical activities and pre-launch inventory manufactured prior to regulatory approval being obtained or deemed to be probable; 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. 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 comprises 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 $10.5 million, $8.7 million and $3.8 million in 2022, 2021 and 2020, 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 when, 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 from prior years to change significantly in 2023. Operating and Finance Leases The Company determines at an arrangement’s inception whether it is a lease. 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 accrued and 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 lease term. The terms of vehicles leased under the Company’s fleet agreement (“Vehicle Lease Agreement”) are 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. Assets under finance leases are depreciated to operating expenses on a straight-line basis over the lease term. 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 are recorded as an element of stockholders’ equity (deficit), but are excluded from net (loss) income. The Company’s other comprehensive (loss) income includes unrealized gain (loss) on available-for-sale securities and foreign currency translation adjustments in 2022, 2021 and 2020. 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 2022. As a result, there was no change to total assets in the consolidated balance sheets or net cash (used in) provided by operating activities in the consolidated statements of cash flows for the prior years. Recent Accounting Pronouncements The Company has reviewed 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, 2022 | |
Revenue | |
Revenue | 2. The Company initiated sales in the United States of CIMERLI on October 3, 2022. The Company’s net revenue was as follows: Year Ended December 31, (in thousands) 2022 2021 2020 Products UDENYCA $ 203,814 $ 326,509 $ 475,824 CIMERLI 6,946 — — Total net product revenue 210,760 326,509 475,824 Other 282 42 — Total net revenue $ 211,042 $ 326,551 $ 475,824 Revenue by significant Customer was as follows: Year Ended December 31, 2022 2021 2020 McKesson Corporation 38 % 39 % 38 % AmeriSource-Bergen Corporation 44 % 39 % 37 % Cardinal Health, Inc. 17 % 20 % 23 % 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, 2022 Chargebacks Other Fees, and Discounts Co-pay for Prompt Assistance (in thousands) Payment Rebates and Returns Total Balances at December 31, 2021 $ 29,665 $ 54,004 $ 26,054 $ 109,723 Provision related to sales made in: Current period 436,865 68,399 73,435 578,699 Prior period (2,090) (1,050) 32 (3,108) Payments and customer credits issued (421,763) (82,640) (80,408) (584,811) Balances at December 31, 2022 $ 42,677 $ 38,713 $ 19,113 $ 100,503 Year Ended December 31, 2021 Chargebacks Other Fees, and Discounts Co-pay for Prompt Assistance (in thousands) Payment Rebates and Returns Total Balances 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) Balances at December 31, 2021 $ 29,665 $ 54,004 $ 26,054 $ 109,723 Year Ended December 31, 2020 Balances 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) Balances 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 and other liabilities, non-current in the accompanying consolidated balance sheets. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2022 | |
Fair Value Measurements | |
Fair Value Measurements | 3. The fair value of financial instruments are classified into one of the following categories based upon the lowest level of input that is significant to the fair value measurement ● 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. There were no transfers Level 1 Level 2 Level 3 during Financial assets measured at fair value on a recurring basis are summarized as follows: Fair Value Measurements December 31, 2022 (in thousands) Level 1 Level 2 Level 3 Total Financial Assets: Money market funds $ 55,060 $ — $ — $ 55,060 Marketable debt securities: U.S. government agency securities 19,964 — — 19,964 U.S. treasury securities 68,418 — — 68,418 Commercial paper and corporate notes — 48,203 — 48,203 Total $ 143,442 $ 48,203 $ — $ 191,645 The financial assets at December 31, 2021 consisted of money market funds and were classified as Level 1. The cost, unrealized gains or losses, and fair value by investment type are summarized as follows: December 31, 2022 (in thousands) Cost Unrealized Gain Unrealized (Loss) Fair Value Money market funds $ 55,060 $ — $ — $ 55,060 U.S. government agency securities 19,929 35 — 19,964 U.S. treasury securities 68,431 8 (21) 68,418 Commercial paper and corporate notes 48,203 — — 48,203 Total $ 191,623 $ 43 $ (21) $ 191,645 The Company held 13 positions that were in unrealized loss positions as of December 31, 2022, and aggregated gross unrealized losses on available-for-sale debt securities were not material. No impairment was recognized in 2022. Excluding restricted cash and as of December 31, 2022, the remaining contractual maturities of available-for-sale securities were less than one year , and the average maturity of investments upon acquisition was approximately 7 months . The accrued interest receivable on available-for-sale marketable securities was immaterial at December 31, 2022, and is included in other prepaids and current assets. There were no investments in marketable securities as of December 31, 2021; thus, no unrealized gain (loss) was recognized as of December 31, 2021. |
Inventory
Inventory | 12 Months Ended |
Dec. 31, 2022 | |
Inventory | |
Inventory | 4. Inventory consisted of the following: December 31, (in thousands) 2022 2021 Raw materials $ 10,262 $ 4,870 Work in process 86,712 65,117 Finished goods 18,077 23,265 Total $ 115,051 $ 93,252 The Company began capitalizing YUSIMRY inventory in the second quarter of 2022 and had $23.7 million of such inventory recognized in the consolidated balance sheets at December 31, 2022. Inventory expected to be sold more than twelve months from the balance sheet date is classified as inventory, non-current in the consolidated balance sheets. As of December 31, 2022 and 2021, the non-current portion of inventory consisted of raw materials, work in process and a portion of finished goods. The following table presents the inventory balance sheet classifications: December 31, (in thousands) 2022 2021 Inventory $ 38,791 $ 37,642 Inventory, non-current 76,260 55,610 Total $ 115,051 $ 93,252 Prepaid manufacturing of $17.9 million as of December 31, 2022 includes prepayments of $13.0 million to CMOs for manufacturing services of the Company’s products, which the Company expects to be converted into inventory during 2023; and prepayments of $4.9 million to various CMOs for research and development pipeline programs. 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; and prepayments of $5.4 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 in 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. No material expense relating to the discontinuation of CHS-2020 was recognized after March 31, 2021. |
Balance Sheet Components
Balance Sheet Components | 12 Months Ended |
Dec. 31, 2022 | |
Balance Sheet Components | |
Balance Sheet Components | 5. Property and Equipment, Net Property and equipment, net consisted of the following: December 31, (in thousands) 2022 2021 Machinery and equipment $ 12,944 $ 11,876 Computer equipment and software 3,183 3,033 Furniture and fixtures 1,258 1,129 Leasehold improvements 6,198 5,942 Finance lease right of use assets 4,632 2,294 Construction in progress 696 388 Total property and equipment 28,911 24,662 Accumulated depreciation and amortization (20,157) (16,849) Property and equipment, net $ 8,754 $ 7,813 Depreciation and amortization expense related to property and equipment, net was $3.6 million, $3.5 million, and $2.9 million in 2022, 2021 and 2020, respectively. There were no material impairments of property and equipment in 2022, 2021 and 2020. As of December 31, 2022 and 2021, the net book value of software implementation costs related to hosting arrangements was $3.5 million and $1.3 million, respectively, and the amortization expense was immaterial for all periods presented. Accrued and Other Current Liabilities Accrued and other current liabilities consisted of the following: December 31, (in thousands) 2022 2021 Accrued commercial and research and development manufacturing $ 21,774 $ 30,541 Accrued co-development costs payable to Junshi Biosciences 8,356 1,926 Lease liabilities, current 4,318 3,492 Accrued other 15,649 12,168 Total Accrued and other current liabilities $ 50,097 $ 48,127 |
Collaborations and Other Arrang
Collaborations and Other Arrangements | 12 Months Ended |
Dec. 31, 2022 | |
Collaborations and Other Arrangements | |
Collaborations and Other Arrangements | 6. Collaborations and Other Arrangements Junshi Biosciences On February 1, 2021, the Company entered into the 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, an option in these territories to Junshi Biosciences’ anti-TIGIT antibody CHS-006, an option in these territories to a 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. In March 2022, the Company paid $35.0 million for the exercise of its option to license CHS-006. Junshi Biosciences and the Company are jointly developing CHS-006 with each party responsible for the associated development costs as set forth in the Collaboration Agreement. If the Company exercises its remaining option for the IL-2 cytokine, it will be obligated to pay an additional option exercise fee of $35.0 million. Additionally, for each exercised option, the Company will be obligated to pay Junshi Biosciences an 18% royalty on net sales, up to $85.0 million for the achievement of certain regulatory approvals, and up to $170.0 million for the attainment of certain sales thresholds. Under the Collaboration Agreement, the Company retains the right to collaborate in the development of toripalimab and the other licensed compounds, including CHS-006, 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 licensing transaction and the exercise of the option were accounted for as asset acquisitions under the relevant accounting rules. Research and development expenses recognized for obligations to Junshi Biosciences were $68.5 million in 2022, inclusive of the $35.0 million option fee, $175.4 million in 2021, and $5.0 million in 2020 representing the right of first negotiation fee which was fully credited against the total upfront license fee obligation under the Collaboration Agreement. The first quarter of 2021 included $145.0 million for the upfront payment for the exclusive rights to toripalimab and the second quarter of 2021 included a credit of $9.0 million for the DLOM, discussed below. Accrued and other current liabilities in the consolidated balance sheets as of December 31, 2022 and 2021 included $8.4 million and $1.9 million, respectively, related to the co-development, regulatory and technology transfer costs related to these programs. A $25.0 million milestone payment will be due upon the regulatory approval of toripalimab. Junshi Biosciences and the Company have not received an action letter from the FDA regarding the BLA for toripalimab in combination with chemotherapy as treatment for recurrent or metastatic nasopharyngeal carcinoma by the Prescription Drug User Fee Action date of December 23, 2022. The FDA previously communicated that on-site inspections, including Junshi Biosciences’ manufacturing facility for toripalimab, are required before the FDA can approve the original BLA; however, they were unable to conduct the inspection by December 23, 2022 due to the impact of COVID-19 related restrictions on travel in China. The BLA for toripalimab remains under review, and Junshi Biosciences and the Company are engaged in ongoing discussions with the FDA about the pre-approval inspection plans. The Company plans to launch toripalimab in the United States in the third quarter of 2023, if approved by July 1, 2023. As of December 31, 2022, the Company did not have any outstanding milestone or royalty payment obligations to Junshi Biosciences. The additional milestone payments, option fee for the IL-2 cytokine and royalties are contingent upon future events and, therefore, will be recorded if and when it becomes probable that a milestone will be achieved, or when an option fee or royalties are incurred. 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 amount of approximately $50.0 million in 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. Under the Innovent Agreement, the Company paid Innovent $5.0 million upfront and committed to pay 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. 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 the 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, and during 2022 this research and development expense was immaterial. As of December 31, 2022, the Company did not have any outstanding milestone or royalty payment obligations to Innovent. On May 3, 2022, the Company provided notice of termination of the Innovent Agreement to Innovent because regulatory approval of the licensed product could not be reasonably obtained within the agreed time period. In connection therewith, the Company has discontinued development of the bevacizumab Licensed Product. Bioeq On November 4, 2019, the Company entered into the Bioeq 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 for ten 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. Bioeq will manufacture and supply the Bioeq Licensed Products to the Company in accordance with terms and conditions specified in the Bioeq Agreement and the Bioeq Manufacturing Agreement and will remain in force until the first to occur of the following: (1) the termination of the Bioeq Agreement; (2) the exercise of a right to termination by the Company or Bioeq for a material breach of the other party that is not cured in accordance with the Bioeq Manufacturing Agreement; and (3) the exercise of a right to termination by Bioeq if invoices are not paid in full in accordance with the Bioeq Manufacturing Agreement. 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 terms of the Bioeq Agreement include 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 including a €2.5 million milestone related to the FDA approval of the CIMERLI Section 351(k) BLA that was paid in 2022. This was recorded as an intangible asset and is being amortized over ten years. The Company shares 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. Royalties due to Bioeq were $2.9 million as of December 31, 2022. The remaining milestone payments are contingent upon future events and, therefore, will be recorded when it becomes probable that a milestone will be achieved. |
Debt Obligations
Debt Obligations | 12 Months Ended |
Dec. 31, 2022 | |
Debt Obligations | |
Debt Obligations | 7. A summary of the Company’s debt obligations, including level within the fair value hierarchy (see Note 3), is as follows: At December 31, 2022 (in thousands) Principal Amount Unamortized Debt Discount and Debt Issuance Costs Net Carrying Value Estimated Fair Value Level Financial Liabilities: 2027 Term Loans $ 250,000 $ (4,517) $ 245,483 $ 245,483 Level 2* 2026 Convertible Notes $ 230,000 $ (4,425) $ 225,575 $ 157,205 Level 2** At December 31, 2021 (in thousands) Principal Amount Unamortized Exit Fee, Debt Discount and Debt Issuance Costs Net Carrying Value Estimated Fair Value Level Financial Liabilities: 2026 Convertible Notes $ 230,000 $ (5,712) $ 224,288 $ 271,860 Level 2** 2022 Convertible Notes $ 109,000 $ (521) $ 108,479 $ 108,361 Level 3*** 2025 Term Loan $ 75,000 $ 513 $ 75,513 $ 75,513 Level 2* * The principal amounts outstanding are subject to variable interest rates, which are based on three-month LIBOR plus fixed percentages through March 31, 2023. Therefore, the Company believes the carrying amount of these obligations approximates fair value. ** The fair value is influenced by interest rates, the Company’s stock price and stock price volatility and is determined by prices observed in market trading. Since the market for trading of the 2026 Convertible Notes is not considered to be an active market, the estimated fair value is based on Level 2 inputs. *** The fair value was based on an income approach using 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 were Level 3 inputs. The lattice model produced 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 was used to discount straight debt cash flows. 2027 Term Loans The Company entered into the Loan Agreement with BioPharma Credit, PLC, BPCR Limited Partnership, and Biopharma Credit Investments V (Master) LP, acting by its general partner, BioPharma Credit Investments V GP LLC that provides for a senior secured term loan facility of up to $300.0 million to be funded in four committed tranches: (i) the Tranche A Loan in an aggregate principal amount of $100.0 million that was funded on January 5, 2022; (ii) the Tranche B Loan in an aggregate principal amount of $100.0 million that was funded on March 31, 2022; (iii) the Tranche C Loan in an aggregate principal amount of $50.0 million that was not funded; and (iv) the Tranche D Loan in an aggregate principal amount of $50.0 million that was funded on September 14, 2022. The Company has the right to request an uncommitted additional facility amount of up to $100.0 million that is 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 the Company’s 2026 Convertible Notes is greater than $50.0 million on October 1, 2025. The 2027 Term Loans accrue interest from inception through March 31, 2023 at 8.25% plus three-month LIBOR per annum with a LIBOR floor of 1.0%; and, starting April 1, 2023, accrue interest at 8.25% plus the Adjusted Term SOFR which is the sum of three-month SOFR and 0.26161% per annum, with a floor on Adjusted Term SOFR of 1.0%. The interest rate for the fourth quarter of 2022 was 12.00%. Interest is payable quarterly in arrears on March 31, June 30, September 30 and December 31 of each year. Repayment of outstanding principal of the 2027 Term Loans will be made in five equal quarterly payments of principal commencing March 31, 2026. The Company adopted the prospective method to account for future cash payments. Under the prospective method, 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. 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 the Company’s 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; in March 2022, proceeds of the Tranche B Loan were drawn in connection with the full repayment of all amounts outstanding under the 2022 Convertible Notes, as well as all associated costs and expenses pursuant to which a payoff amount of $111.1 million was outstanding. The Loan Agreement contains certain customary representations and warranties. In addition, the Loan Agreement includes covenants, such as the requirement to maintain minimum trailing twelve-month net sales in an amount that begins at $200.0 million for the quarter ending March 31, 2022, increases to $210.0 million for the quarter ended March 31, 2024, increases to $230.0 million for the quarter ending June 30, 2024, increases to $270.0 million for the quarter ending September 30, 2024, and increases to $300.0 million for the quarter ended December 31, 2024 and thereafter. Further, the Loan Agreement includes certain other affirmative covenants and negative covenants, including, covenants and restrictions that among other things, restrict the Company’s 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, the Company’s failure to make any principal or interest payments when due, the occurrence of certain bankruptcy or insolvency events or its breach of the covenants under the Loan Agreement. Upon the occurrence of an event of default, the Lenders may, among other things, accelerate the Company’s obligations under the Loan Agreement. A change of control of the Company triggers a mandatory prepayment of the 2027 Term Loans within ten business days. As of December 31, 2022, the Company was in full compliance with these covenants and there were no events of default under the 2027 Term Loans. In connection with the closing of Tranche A, the Company incurred $7.8 million in debt discounts and issuance costs The following table represents the components of interest expense related to the 2027 Term Loans: Year Ended December 31, (in thousands) 2022 Stated coupon interest $ 20,243 Amortization of debt discount and debt issuance costs 4,550 Total interest expense $ 24,793 Future payments on the 2027 Term Loans as of December 31, 2022 are as follows: Year ending December 31, (in thousands) 2023 - interest only $ 30,412 2024 - interest only 30,496 2025 - interest only 30,412 2026 - principal and interest 221,231 2027 - principal and interest 50,083 Total minimum payments 362,634 Less amount representing interest (112,634) 2027 Term Loans, gross 250,000 Less unamortized debt discount and debt issuance costs, net (4,517) Net carrying amount of 2027 Term Loans $ 245,483 1.5% Convertible Senior Subordinated Notes due 2026 In April 2020, the Company issued and sold $230.0 million aggregate principal amount of its 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 $14.82 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, 2022, 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 in 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 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 $25.93 per share, which represents a premium of approximately 75.0% over the last reported sale price of the Company’s common stock of $14.82 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 in 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 in 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. If the 2026 Convertible Notes were converted on December 31, 2022, the holders of the 2026 Convertible Notes would have received common shares with an aggregate value of $94.6 million based on the Company’s closing stock price of $7.92 as of December 30, 2022. The following table presents the components of interest expense related to 2026 Convertible Notes: Year Ended December 31, (in thousands) 2022 2021 2020 Stated coupon interest $ 3,450 $ 3,450 $ 2,434 Amortization of debt discount and debt issuance costs 1,286 1,259 873 Total interest expense $ 4,736 $ 4,709 $ 3,307 The remaining unamortized debt discount and debt offering costs related to the Company’s 2026 Convertible Notes of $4.4 million as of December 31, 2022, will be amortized using the effective interest rate over the remaining term of the 2026 Convertible Notes of 3.3 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, 2022 are as follows: Year ending December 31, (in thousands) 2023 - interest only $ 3,450 2024 - interest only 3,450 2025 - interest only 3,450 2026 231,725 Total minimum payments 242,075 Less amount representing interest (12,075) 2026 Convertible Notes, principal amount 230,000 Less unamortized debt discount and debt issuance costs (4,425) Net carrying amount of 2026 Convertible Notes $ 225,575 8.2% Convertible Notes due 2022 On February 29, 2016, the Company issued and sold $100.0 million aggregate principal amount, which excluded a 9.0% premium due at maturity or redemption, of its 2022 Convertible Notes . The 2022 Convertible Notes constituted general, senior unsubordinated obligations of the Company and were guaranteed by certain subsidiaries of the Company. The 2022 Convertible Notes bore 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 matured on March 31, 2022 The 2022 Convertible Notes also had a premium of 9.0% of the principal amount which was payable when the 2022 Convertible Notes matured or were 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 could have converted 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 was 44.7387 shares of common stock per $1,000 principal amount of the 2022 Convertible Notes, which represented an initial conversion price of approximately $22.35 per share of common stock. The initial conversion price represented a 60% premium over the average last reported sale price of the Company’s common stock over the 15 trading days preceding the date the 2022 Convertible Notes were issued. The conversion rate and conversion price were subject to customary adjustments upon the occurrence of certain events. The 2022 Convertible Notes were 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 exceeded 160% of the conversion price on 20 or more trading days during the 30 consecutive trading days preceding the date on which the Company sent notice of such redemption to the holders of the 2022 Convertible Notes. At maturity or redemption, if not earlier converted, the Company would pay 109% of the principal amount of the 2022 Convertible Notes maturing or being redeemed, together with accrued and unpaid interest, in cash. In March 2022, the Company fully repaid the 2022 Convertible Notes, and a s a result had no continuing obligations associated with them thereafter The following table presents the components of interest expense of the 2022 Convertible Notes: Year Ended December 31, (in thousands) 2022 2021 2020 Stated coupon interest $ 2,050 $ 8,200 $ 8,200 Amortization of debt discount and debt issuance costs 521 1,966 1,791 Total interest expense $ 2,571 $ 10,166 $ 9,991 2025 Term Loan On January 7, 2019 (the “2025 Term Loan Closing Date”), the Company entered into the 2025 Term Loan with affiliates of Healthcare Royalty Partners (together, the “Lender”). The 2025 Term Loan consisted 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 were guaranteed by the Company’s material domestic United States subsidiaries and were secured by a lien on substantially all of the Company’s tangible and intangible property, including intellectual property. Starting January 1, 2020, the Borrowings under the 2025 Term Loan bore interest at 6.75% per annum plus three month LIBOR. Interest was payable quarterly in arrears. Under the prospective method to account for future cash payments adopted by the Company, the effective interest rate was not constant, and any change in the expected cash flows was recognized prospectively as an adjustment to the effective yield. If all or any of the Borrowings were prepaid or required to be prepaid under the 2025 Term Loan, then the Company was required to 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, the Company was required to pay an additional exit fee in an amount equal to 4.0% of the total principal amount of the Borrowings. 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. In January 2022, pursuant to the Company entering into the 2027 Term Loans, the Company voluntarily prepaid all amounts outstanding under the 2025 Term Loan. The payoff amount of $81.9 million included principal repayment in full, accrued interest, a 5.0% prepayment premium fee of the Borrowings principal amount, and an exit fee of 4.0% of the Borrowings principal amount. The prepayment premium fee and unamortized exit fee, debt discount and debt issuance costs, net from the 2025 Term Loan totaled $6.2 million and was recorded in loss on debt extinguishment in the consolidated statement of operations for 2022. As of December 31, 2022, the Company had no continuing obligations associated with the 2025 Term Loan. The following table presents the components of interest expense of the 2025 Term Loan: Year Ended December 31, (in thousands) 2022 2021 2020 Stated coupon interest $ 154 $ 7,034 $ 7,053 Amortization of debt discount and debt issuance costs 16 1,032 818 Total interest expense $ 170 $ 8,066 $ 7,871 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2022 | |
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, 2022, the Company’s non-cancelable purchase commitments under the terms of its agreements are as follows: Year ending December 31, (in thousands) 2023 $ 53,652 2024 13,724 2025 1,128 2026 260 Total obligations $ 68,764 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 assesses 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 and Other Claims 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 a material accrual for such matters as of December 31, 2021 and established an accrual of approximately $4.7 million as of December 31, 2022 that was included in accrued rebates, fees and reserves in the consolidated balance sheets. In late April of 2022, the Company received a demand letter from Zinc Health Services, LLC (“Zinc”) asserting that Zinc was entitled to approximately $14.0 million from the Company for claims related to certain sales of UDENYCA from October 2020 through December 2021. The Company is continuing to evaluate the claims in the letter. No legal proceeding has been filed in connection with the claims in the letter and based on currently available information the final resolution of the matter is uncertain. The Company intends to defend any legal proceeding that may be filed. The Company established an accrual as of December 31, 2022 that represented its estimated liability to resolve the matter. Loss contingencies are inherently unpredictable, the assessment is highly subjective and requires judgments about future events and unfavorable developments or resolutions can occur. The Company regularly reviews litigation matters to determine whether its accrual is adequate. The amount of ultimate loss may differ materially from the amount accrued to date . Other than the matter in connection with the demand letter described in this Note 8, there are no 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, 2022 | |
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 the Vehicle Lease Agreement, pursuant to which the Company currently leases approximately 100 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, Leases Supplemental information related to the Company’s leases is as follows: (in thousands) December 31, Assets Balance Sheet Classification 2022 2021 Operating leases Other assets, non-current $ 5,690 $ 8,193 Finance leases Property and equipment, net 2,584 1,220 Total leased assets $ 8,274 $ 9,413 (in thousands) December 31, Liabilities Balance Sheet Classification 2022 2021 Operating lease liabilities, current Accrued and other current liabilities $ 3,127 $ 2,751 Operating lease liabilities, non-current Lease liabilities, non-current 3,628 6,753 Total operating lease liabilities $ 6,755 $ 9,504 Finance lease liabilities, current Accrued and other current liabilities $ 1,191 $ 741 Finance lease liabilities, non-current Lease liabilities, non-current 1,418 498 Total finance lease liabilities $ 2,609 $ 1,239 Other information related to lease term and discount rate is as follows: December 31, 2022 2021 Weighted-Average Remaining Lease Term Operating leases 2.2 years 3.2 years Finance leases 2.2 years 1.7 years Weighted-Average Discount Rate Operating leases 8.0% 8.0% Finance leases 8.4% 5.8% The components of lease expense were as follows: Year Ended December 31, (in thousands) 2022 2021 2020 Finance lease cost Amortization of right-of-use assets $ 1,228 $ 707 $ 368 Interest on lease liabilities 166 82 57 Total finance lease cost 1,394 789 425 Operating lease cost 3,154 3,066 3,126 Total lease cost $ 4,548 $ 3,855 $ 3,551 Supplemental cash flow information related to leases was as follows: Year Ended December 31, (in thousands) 2022 2021 2020 Cash paid for amounts included in measurement of lease liabilities: Operating cash flows from operating leases $ 3,401 $ 3,435 $ 3,217 Operating cash flows from finance leases $ 155 $ 81 $ 53 Financing cash flows from finance leases $ 1,228 $ 672 $ 388 Right-of-use assets obtained in exchange for lease obligations: Operating leases $ — $ 434 $ 1,388 Finance leases $ 2,694 $ 477 $ 1,817 As of December 31, 2022, the maturities of the lease liabilities were as follows: Year ending December 31, (in thousands) Operating leases Finance leases 2023 $ 3,560 $ 1,354 2024 3,014 1,026 2025 412 481 2026 292 — 2027 and thereafter 124 — Total lease payments 7,402 2,861 Less imputed interest (647) (252) Lease liabilities $ 6,755 $ 2,609 |
At The Market Offering
At The Market Offering | 12 Months Ended |
Dec. 31, 2022 | |
At-The-Market Offering | |
At The Market Offering | 10. On November 8, 2022, the Company filed a Registration Statement on Form S-3, which was declared effective on November 17, 2022. Under the Registration Statement, the Company may offer and sell up to $150.0 million in the aggregate of its common stock, preferred stock, debt securities, warrants and units from time to time in one or more offerings. Also on November 8, 2022, the Company entered into a Sales Agreement with Cowen, pursuant to which the Company may issue and sell from time to time up to $150.0 million of its common stock through or to Cowen as the Company’s sales agent or principal in the ATM Offering. As of December 31, 2022, the Company sold 916,884 shares of common stock at a weighted-average price per share of $7.30 for gross proceeds of $6.7 million pursuant to the ATM Offering and received net proceeds of $6.5 million, net of $0.2 million of commissions and fees. In January 2023, the Company settled an additional 295,200 shares at a weighted-average price per share of $7.41 for gross proceeds of $2.2 million pursuant to the ATM Offering and received net proceeds of $2.1 million, net of $0.1 million of commissions and fees. |
Stock-Based Compensation and Em
Stock-Based Compensation and Employee Benefits | 12 Months Ended |
Dec. 31, 2022 | |
Stock-Based Compensation and Employee Benefits | |
Stock-Based Compensation and Employee Benefits | 11. 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, 2022. There were 1,252,865 shares of common stock available for future issuance as of December 31, 2022 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, 2022, the Company had 861,312 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 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 Weighted- Average Aggregate Weighted- Remaining Intrinsic Number of Average Contractual Terms Value Options Exercise Price (Years) (in thousands) Outstanding at December 31, 2021 19,959,815 $ 15.89 Granted - at fair value 4,685,750 $ 12.09 Exercised (141,897) $ 4.88 Forfeited/Canceled (2,812,347) $ 16.97 Outstanding at December 31, 2022 21,691,321 $ 15.00 6.0 $ 10,714 Exercisable at December 31, 2022 15,027,783 $ 15.47 4.8 $ 9,647 Aggregate intrinsic value represents the value of the Company’s closing stock price on the last trading day of the year in excess of the exercise price multiplied by the number of options outstanding or exercisable. Information on options outstanding and exercisable as of December 31, 2022 is summarized as follows: Options Outstanding Options Exercisable Weighted- Average Weighted- Weighted- Remaining Average Average Number Contractual Terms Exercise Number Exercise Range of Exercise Prices Outstanding (Years) Price Exercisable Price $ 1.42 - $ 10.05 4,801,972 5.2 $ 6.64 3,223,663 $ 5.99 $ 10.78 - $ 14.13 4,598,418 6.4 $ 12.72 3,381,021 $ 12.67 $ 14.30 - $ 17.17 4,857,557 7.2 $ 15.91 2,530,714 $ 16.08 $ 17.30 - $ 19.07 4,406,311 6.9 $ 17.93 3,000,465 $ 17.94 $ 19.19 - $ 36.85 3,027,063 3.4 $ 25.98 2,891,920 $ 26.22 21,691,321 6.0 $ 15.00 15,027,783 $ 15.47 The intrinsic value is defined as the difference between the current market value and the exercise price. Additional information on options is summarized as follows: Year Ended December 31, (in thousands, except weighted-average grant date fair values) 2022 2021 2020 Total intrinsic value of options exercised $ 914 $ 9,726 $ 14,572 Total grant date fair value of options vested $ 34,916 $ 40,365 $ 34,090 Weighted-average grant date fair value of options granted $ 7.04 $ 9.80 $ 10.94 As of December 31, 2022, total unrecognized stock-based compensation expense related to unvested stock options was $51.5 million, which is expected to be recognized over a weighted-average period of 2.7 years. Restricted Stock Units The Company grants RSUs primarily to its employees. RSUs are share awards that entitle the holder to receive freely tradable shares of the Company’s 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 applicable grant date, provided the employee remains continuously employed with the Company. The estimated fair value of RSUs is based on the closing price of the Company’s common stock on the grant date. 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, 2021 1,843,732 $ 17.00 RSUs granted 1,686,875 $ 13.34 RSUs vested (806,854) $ 16.85 RSUs canceled (390,446) $ 15.43 Balances at December 31, 2022 2,333,307 $ 14.66 The total grant-date fair value of RSUs that vested during 2022, 2021 and 2020 was $13.6 million, $8.4 million and $4.1 million, respectively. The total grant-date fair value of RSUs granted was $22.5 million, $27.9 million and $21.2 million during 2022, 2021 and 2020, respectively. The estimated weighted-average grant-date fair value per share of RSUs granted during 2022, 2021 and 2020 was $13.34, $16.86 and $17.86, respectively. As of December 31, 2022, total unrecognized stock-based compensation expense related to unvested RSUs was $20.3 million, which is expected to be recognized over a weighted-average period of 1.5 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 3,172,117 shares of common stock available for future issuance as of December 31, 2022. 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 The following table summarizes the classification of stock-based compensation expense in the Company’s consolidated financial statements related to options and RSUs granted to employees and nonemployees: Year Ended December 31, (in thousands) 2022 2021 2020 Cost of goods sold (1) $ 736 $ 1,099 $ 583 Research and development 18,999 18,688 13,837 Selling, general and administrative 31,002 31,577 23,740 Stock-based compensation expense $ 50,737 $ 51,364 $ 38,160 Stock-based compensation expense capitalized into inventory $ 1,187 $ 1,025 $ 1,460 (1) Stock-based compensation capitalized into inventory is recognized as cost of goods sold 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, 2022, 2021 and 2020: Year Ended December 31, 2022 2021 2020 Expected term (years) Stock options 6.1 6.1 6.1 ESPP 0.5 0.5 0.5 Expected volatility Stock options 62 % 65 % 68 % ESPP 70 % 42 % 58 % Risk-free interest rate Stock options 2.37 % 0.89 % 1.09 % ESPP 3.77 % 0.06 % 0.13 % 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, 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 $2.1 million, $1.7 million and $0.8 million in 2022, 2021 and 2020, respectively. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2022 | |
Income Taxes | |
Income Taxes | 12. The components of (loss) income before income taxes are as follows: Year Ended December 31, (in thousands) 2022 2021 2020 Domestic $ (291,746) $ (287,058) $ 133,615 Foreign (8) (42) 2,092 Total $ (291,754) $ (287,100) $ 135,707 Provision for income taxes: Year Ended December 31, (in thousands) 2022 2021 2020 Current: Federal $ — $ — $ — State — — 3,463 Foreign — — — Subtotal $ — $ — $ 3,463 Deferred: Federal $ — $ — $ — State — — — Foreign — — — Subtotal $ — $ — $ — Provision for income taxes $ — $ — $ 3,463 There was no income tax provision in 2022 and 2021 due to the Company’s history of losses and valuation of allowances against the deferred tax assets. The income tax provision in 2020 of $3.5 million is primarily related 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, 2022 2021 2020 Percent of pre-tax income: United States federal statutory income tax rate 21.0 % 21.0 % 21.0 % State taxes, net of federal benefit 1.7 2.6 2.0 Foreign rate differences — — (0.3) Permanent items (0.1) 0.2 0.4 Research and development credit 1.8 2.6 (4.8) Stock-based compensation costs (2.3) (1.2) 1.3 Other — — (0.3) Change in valuation allowance (22.1) (25.2) (16.7) Effective income tax rate — % — % 2.6 % The components of the Company’s net deferred tax assets as of December 31, 2022 and 2021 consist of the following: December 31, (in thousands) 2022 2021 Net operating loss carryforwards $ 131,423 $ 117,793 Research and development credits 63,164 58,039 Depreciation and amortization 51,877 40,620 Stock-based compensation 32,561 30,565 Sales related accruals 23,864 17,299 Other accruals 19,717 11,798 Capitalized research and development 17,673 — Gross deferred tax assets 340,279 276,114 Right-of-use asset (1,903) (2,167) In-process research and development (603) (603) Gross deferred tax liabilities (2,506) (2,770) Total net deferred tax asset 337,773 273,344 Less valuation allowance (337,773) (273,344) 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, 2022 and 2021. The valuation allowance increased by $64.4 million and $72.4 million during the years ended December 31, 2022 and 2021, respectively, and decreased by $22.7 million during the year ended December 31, 2020. As of December 31, 2022, the Company had operating loss carryforwards for federal income of $591.2 million, which will start to expire in the year 2036, and various states net operating loss carryforwards of $113.2 million, which have various expiration dates beginning in 2031. As of December 31, 2022, the Company had federal research and development credit carryforwards for federal income tax purposes of $57.7 million, which will start to expire in the year 2031, and state research and development credit carryforwards of $26.4 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 income tax returns in the United States federal jurisdiction, various United States state jurisdictions, and a foreign jurisdiction 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 2022, 2021 and 2020 is as follows: Year Ended December 31, (in thousands) 2022 2021 2020 Balance at beginning of year $ 15,495 $ 13,243 $ 11,603 Additions based on tax positions related to current year 1,385 2,038 1,749 Additions (reductions) for tax positions of prior years (42) 214 (109) Balance at end of year $ 16,838 $ 15,495 $ 13,243 As of December 31, 2022, 2021 and 2020, the Company had $16.8 million, $15.5 million and $13.2 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 2022, 2021 and 2020, 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. |
Net (Loss) Income Per Share
Net (Loss) Income Per Share | 12 Months Ended |
Dec. 31, 2022 | |
Net (Loss) Income Per Share | |
Net (Loss) Income Per Share | 13. The following table sets forth the computation of the basic and diluted net (loss) income per share: Year Ended December 31, (in thousands, except share and per share data) 2022 2021 2020 Basic net (loss) income per share Numerator: Net (loss) income $ (291,754) $ (287,100) $ 132,244 Denominator: Weighted-average common shares outstanding 77,630,020 75,449,632 71,411,705 Basic net (loss) income per share $ (3.76) $ (3.81) $ 1.85 Diluted net (loss) income per share Numerator: Net (loss) income $ (291,754) $ (287,100) $ 132,244 Add interest expense on 2026 Convertible Notes, net of tax — — 3,307 Numerator for diluted net (loss) income per share (291,754) (287,100) 135,551 Denominator: Denominator for basic net (loss) income per share 77,630,020 75,449,632 71,411,705 Add effect of potential dilutive securities: Stock options, including shares subject to ESPP — — 3,455,646 Restricted stock units — — 167,597 Shares issuable upon conversion of convertible notes — — 8,456,950 Denominator for diluted net (loss) income per share 77,630,020 75,449,632 83,491,898 Diluted net (loss) income per share $ (3.76) $ (3.81) $ 1.62 The 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, 2022 2021 2020 Stock options, including shares subject to ESPP 22,214,875 19,895,097 9,521,403 Restricted stock units 2,399,465 1,811,607 7,689 Shares issuable upon conversion of 2022 Convertible Notes 1,078,632 4,473,871 4,473,871 Shares issuable upon conversion of 2026 Convertible Notes 11,942,152 11,942,152 — Total 37,635,124 38,122,727 14,002,963 |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2022 | |
Related Party Transactions | |
Related Party Transactions | 14. Related Party Transactions 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. There have been no subsequent material related party expenses. Total liabilities recognized in the consolidated balance sheets with respect to these services were immaterial as of December 31, 2022 and 2021. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2022 | |
Subsequent Events | |
Subsequent Events | 15. Subsequent Events On January 9, 2023, the Company announced that it entered into the Term Sheet with Klinge Biopharma for the exclusive commercialization rights to FYB203, a biosimilar candidate to Eylea® (aflibercept), in the United States. The parties to the Term Sheet expect to execute the Definitive Agreements contemplated by the Term Sheet and complete the transaction in the first half of 2023. Under the Term Sheet, the Company will make a total upfront payment of approximately €30 million, comprised of cash and the Company’s common stock, thirty days after the execution of the Definitive Agreements. The Company has also agreed to make other regulatory and launch milestone payments and to make royalty payments based on approximately equal sharing of profits from the sale of FYB203 in consideration for the commercialization rights to FYB203 in the United States. The material terms of the transaction with Klinge Biopharma will be set forth in the Definitive Agreements, which will be included in a subsequent filing by the Company when such Definitive Agreements are executed. |
Organization and Significant _2
Organization and Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
Organization and Significant Accounting Policies | |
Basis of Consolidation | 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 COVID-19 outbreaks 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 | 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, as the chief operating decision maker (“CODM”), manages and allocates resources to the operations of the Company on an entity-wide basis. Managing and allocating resources on an entity-wide basis enables the CODM to assess the overall level of resources available and how to best deploy these resources across functions. Primarily, all revenue is generated and all long-lived assets are maintained in the United States. |
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: (in thousands) January 1, At beginning of period: 2022 2021 2020 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 December 31, At end of period: 2022 2021 2020 Cash and cash equivalents $ 63,547 $ 417,195 $ 541,158 Restricted cash 440 440 440 Total cash, cash equivalents and restricted cash $ 63,987 $ 417,635 $ 541,598 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 in 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 U.S. Treasury securities, commercial paper, corporate debt obligations and short-term money market instruments. 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 limits its exposure to any single issuer, except for securities issued by the U.S. government. 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 regularly reviews its investments for declines in fair value below the amortized cost basis to determine whether the impairment, if any, is due to credit-related or other factors. This review includes the credit worthiness of the security issuers, the severity of the unrealized losses, whether the Company has the intent to sell the securities and whether it is more likely than not that the Company will be required to sell the securities before the recovery of the amortized cost basis. Unrealized gains and losses on available-for-sale debt 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 available-for-sale debt 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. There were no impairments related to credit losses during any of the periods presented. Realized gains and losses, if any, on available-for-sale securities are included in other income (expense), net, in the consolidated statements of operations based on the specific identification method. During 2022, 2021 and 2020, interest income from marketable securities was $1.9 million, $1.4 million and $0.6 million, respectively, and is included in other income (expense), net, in the consolidated statements of operations. |
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 and was not material during the periods presented. The Company believes that its allowance for expected credit losses was adequate and immaterial as of December 31, 2022 and 2021. |
Concentration of Risk | Concentrations of Risk The Company’s financial instruments that are exposed to concentration of credit risk consist primarily of cash, cash equivalents, investments in marketable securities and trade receivables. The Company attempts to minimize the risks related to cash, cash equivalents and marketable securities 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. The Company 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. Substantially all of the Company’s revenues are in the United States to three wholesalers. UDENYCA and CIMERLI were the only products sold by the Company during 2022. UDENYCA was the only product sold and accounted for all of the Company’s revenues in 2021 and 2020. The Company enters into a strategic commercial supply agreement for each of its products. The Company currently has not engaged back-up suppliers or vendors. If any of the Company’s current vendors are 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. |
Foreign Currency | Foreign Currency Assets and liabilities denominated in foreign currency are remeasured at period-end exchange rates for monetary assets and liabilities. Non-monetary assets and liabilities denominated in foreign currencies are remeasured at historical rates. Translation gains and losses are included in accumulated other comprehensive loss in stockholders’ equity (deficit). Revenue and expense accounts are translated to U.S. dollars at average exchange rates in effect during the period with resulting transaction gains and losses recognized in other income (expense), net in the consolidated statements of operations. 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. During the third quarter of 2022, the Company recorded a $26.0 million write-down of inventory in cost of goods sold in the consolidated statements of operations due to the competitive environment and lower demand for UDENYCA resulting in certain inventory becoming at risk of expiration. For 2022, this increased the net loss by $26.0 million and basic and diluted net loss per share by $0.33. 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 product candidates, the Company incurred expenses for the manufacture of drug product that could potentially be available to support the commercial launch of the 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. Inventory in the consolidated balance sheets as of December 31, 2022 was related to UDENYCA, YUSIMRY and CIMERLI. |
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 fair value of net assets acquired in a business combination. Goodwill is not amortized but is evaluated for impairment on an annual basis, during the fourth quarter, or more frequently if an event occurs or circumstances change that would more-likely-than-not reduce the fair value of the Company’s single reporting unit below its carrying amount. The Company’s goodwill balance was $0.9 million as of December 31, 2022 and 2021, and no goodwill impairment charges were recognized in 2022, 2021 or 2020. Acquired in-process research and development (“IPR&D”) that the Company acquires in conjunction with the acquisition of a business represents the fair value assigned to incomplete research projects which, at the time of acquisition, have not reached technological feasibility. The amounts are capitalized and are accounted for as indefinite-lived intangible assets, subject to impairment testing until completion or abandonment of the projects. Upon successful completion of each IPR&D project, the Company will make a determination as to the then-useful life of the intangible asset, generally determined by the period in which the substantial majority of the cash flows are expected to be generated, and begin amortization. The Company evaluates IPR&D for impairment on an annual basis, during the fourth quarter, or more frequently if impairment indicators exist. The Company’s IPR&D balance was $2.6 million as of December 31, 2022 and 2021, and no IPR&D impairment charges were recognized in 2022, 2021 or 2020. As of December 31, 2022, the Company had a $2.4 million definite-lived intangible asset, net related to a 2022 capitalized milestone payment under a license agreement. This is amortized on a straight-line basis over its estimated economic life of ten years and is reviewed periodically for impairment. Amortization expense is recorded as a component of cost of goods sold in the consolidated statements of operations and was immaterial in 2022. |
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, 2022, 2021 and 2020. |
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 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 approximately 90 days from date of shipment and may be extended during the launch period of a new product. 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: are classified in selling, general and administrative expense in the Company’s consolidated statements of operations, otherwise they are included as a reduction in product revenue. 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 all periods presented and is included in net revenue. |
Cost of Goods Sold | Cost of Goods Sold Cost of goods sold consists primarily of third-party manufacturing, distribution, and certain overhead costs. Through March 31, 2021, a portion of the costs of producing UDENYCA sold was expensed as research and development before the FDA approval of UDENYCA and therefore is not reflected in cost of goods sold. All the inventory expensed prior to approval of UDENYCA was fully utilized by March 31, 2021; thus, the costs of producing UDENYCA are fully reflected in cost of goods sold beginning April 1, 2021. 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. Additionally, the Company shares 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. In 2022, 2021 and 2020, cost of goods sold included inventory write-offs, net of $26.0 million, $5.1 million and $2.2 million, respectively. |
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 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 collaborators, 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, analytical activities and pre-launch inventory manufactured prior to regulatory approval being obtained or deemed to be probable; 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. |
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 expense comprises 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 $10.5 million, $8.7 million and $3.8 million in 2022, 2021 and 2020, 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 when, 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 from prior years to change significantly in 2023. |
Operating and Finance Leases | Operating and Finance Leases The Company determines at an arrangement’s inception whether it is a lease. 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 accrued and 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 lease term. The terms of vehicles leased under the Company’s fleet agreement (“Vehicle Lease Agreement”) are 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. Assets under finance leases are depreciated to operating expenses on a straight-line basis over the lease term. 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 are recorded as an element of stockholders’ equity (deficit), but are excluded from net (loss) income. The Company’s other comprehensive (loss) income includes unrealized gain (loss) on available-for-sale securities and foreign currency translation adjustments in 2022, 2021 and 2020. Reclassifications |
Reclassifications | Reclassifications |
Recent Accounting Pronouncements | Recent Accounting Pronouncements The Company has reviewed 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. |
Organization and Significant _3
Organization and Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Organization and Significant Accounting Policies | |
Schedule of Reconciliation of Cash, Cash Equivalents and Restricted Cash | (in thousands) January 1, At beginning of period: 2022 2021 2020 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 December 31, At end of period: 2022 2021 2020 Cash and cash equivalents $ 63,547 $ 417,195 $ 541,158 Restricted cash 440 440 440 Total cash, cash equivalents and restricted cash $ 63,987 $ 417,635 $ 541,598 |
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, 2022 | |
Revenue | |
Net revenue initiated sales in the United States of total net revenue | Year Ended December 31, (in thousands) 2022 2021 2020 Products UDENYCA $ 203,814 $ 326,509 $ 475,824 CIMERLI 6,946 — — Total net product revenue 210,760 326,509 475,824 Other 282 42 — Total net revenue $ 211,042 $ 326,551 $ 475,824 |
Gross Revenues by Significant Customer as a Percentage of Total Gross Revenues | Year Ended December 31, 2022 2021 2020 McKesson Corporation 38 % 39 % 38 % AmeriSource-Bergen Corporation 44 % 39 % 37 % Cardinal Health, Inc. 17 % 20 % 23 % |
Activities and Ending Reserve Balances for Each Significant Category of Discounts and Allowances | Year Ended December 31, 2022 Chargebacks Other Fees, and Discounts Co-pay for Prompt Assistance (in thousands) Payment Rebates and Returns Total Balances at December 31, 2021 $ 29,665 $ 54,004 $ 26,054 $ 109,723 Provision related to sales made in: Current period 436,865 68,399 73,435 578,699 Prior period (2,090) (1,050) 32 (3,108) Payments and customer credits issued (421,763) (82,640) (80,408) (584,811) Balances at December 31, 2022 $ 42,677 $ 38,713 $ 19,113 $ 100,503 Year Ended December 31, 2021 Chargebacks Other Fees, and Discounts Co-pay for Prompt Assistance (in thousands) Payment Rebates and Returns Total Balances 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) Balances at December 31, 2021 $ 29,665 $ 54,004 $ 26,054 $ 109,723 Year Ended December 31, 2020 Balances 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) Balances 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, 2022 | |
Fair Value Measurements | |
Cash and cash equivalents, marketable securities and restricted cash | December 31, 2022 (in thousands) Cost Unrealized Gain Unrealized (Loss) Fair Value Money market funds $ 55,060 $ — $ — $ 55,060 U.S. government agency securities 19,929 35 — 19,964 U.S. treasury securities 68,431 8 (21) 68,418 Commercial paper and corporate notes 48,203 — — 48,203 Total $ 191,623 $ 43 $ (21) $ 191,645 |
Inventory (Tables)
Inventory (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Inventory | |
Schedule of Inventory | Inventory consisted of the following: December 31, (in thousands) 2022 2021 Raw materials $ 10,262 $ 4,870 Work in process 86,712 65,117 Finished goods 18,077 23,265 Total $ 115,051 $ 93,252 |
Schedule of Balance Sheet Classification | December 31, (in thousands) 2022 2021 Inventory $ 38,791 $ 37,642 Inventory, non-current 76,260 55,610 Total $ 115,051 $ 93,252 |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Organization and Operations | |
Schedule of Property and Equipment, Net | December 31, (in thousands) 2022 2021 Machinery and equipment $ 12,944 $ 11,876 Computer equipment and software 3,183 3,033 Furniture and fixtures 1,258 1,129 Leasehold improvements 6,198 5,942 Finance lease right of use assets 4,632 2,294 Construction in progress 696 388 Total property and equipment 28,911 24,662 Accumulated depreciation and amortization (20,157) (16,849) Property and equipment, net $ 8,754 $ 7,813 |
Schedule of Accrued Liabilities | December 31, (in thousands) 2022 2021 Accrued commercial and research and development manufacturing $ 21,774 $ 30,541 Accrued co-development costs payable to Junshi Biosciences 8,356 1,926 Lease liabilities, current 4,318 3,492 Accrued other 15,649 12,168 Total Accrued and other current liabilities $ 50,097 $ 48,127 |
Debt Obligations (Tables)
Debt Obligations (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Debt Instrument | |
Summary of the Company's Debt Obligations | At December 31, 2022 (in thousands) Principal Amount Unamortized Debt Discount and Debt Issuance Costs Net Carrying Value Estimated Fair Value Level Financial Liabilities: 2027 Term Loans $ 250,000 $ (4,517) $ 245,483 $ 245,483 Level 2* 2026 Convertible Notes $ 230,000 $ (4,425) $ 225,575 $ 157,205 Level 2** At December 31, 2021 (in thousands) Principal Amount Unamortized Exit Fee, Debt Discount and Debt Issuance Costs Net Carrying Value Estimated Fair Value Level Financial Liabilities: 2026 Convertible Notes $ 230,000 $ (5,712) $ 224,288 $ 271,860 Level 2** 2022 Convertible Notes $ 109,000 $ (521) $ 108,479 $ 108,361 Level 3*** 2025 Term Loan $ 75,000 $ 513 $ 75,513 $ 75,513 Level 2* * The principal amounts outstanding are subject to variable interest rates, which are based on three-month LIBOR plus fixed percentages through March 31, 2023. Therefore, the Company believes the carrying amount of these obligations approximates fair value. ** The fair value is influenced by interest rates, the Company’s stock price and stock price volatility and is determined by prices observed in market trading. Since the market for trading of the 2026 Convertible Notes is not considered to be an active market, the estimated fair value is based on Level 2 inputs. *** The fair value was based on an income approach using 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 were Level 3 inputs. The lattice model produced 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 was used to discount straight debt cash flows. |
2027 Term Loans | |
Debt Instrument | |
Components of Interest Expense | Year Ended December 31, (in thousands) 2022 Stated coupon interest $ 20,243 Amortization of debt discount and debt issuance costs 4,550 Total interest expense $ 24,793 |
Schedule of Future Payments on Debt | Year ending December 31, (in thousands) 2023 - interest only $ 30,412 2024 - interest only 30,496 2025 - interest only 30,412 2026 - principal and interest 221,231 2027 - principal and interest 50,083 Total minimum payments 362,634 Less amount representing interest (112,634) 2027 Term Loans, gross 250,000 Less unamortized debt discount and debt issuance costs, net (4,517) Net carrying amount of 2027 Term Loans $ 245,483 |
1.5% Convertible Senior Subordinated Notes due 2026 | |
Debt Instrument | |
Components of Interest Expense | Year Ended December 31, (in thousands) 2022 2021 2020 Stated coupon interest $ 3,450 $ 3,450 $ 2,434 Amortization of debt discount and debt issuance costs 1,286 1,259 873 Total interest expense $ 4,736 $ 4,709 $ 3,307 |
Schedule of Future Payments on Debt | Future payments on the 2026 Convertible Notes as of December 31, 2022 are as follows: Year ending December 31, (in thousands) 2023 - interest only $ 3,450 2024 - interest only 3,450 2025 - interest only 3,450 2026 231,725 Total minimum payments 242,075 Less amount representing interest (12,075) 2026 Convertible Notes, principal amount 230,000 Less unamortized debt discount and debt issuance costs (4,425) Net carrying amount of 2026 Convertible Notes $ 225,575 |
8.2% Convertible Notes due 2022 | |
Debt Instrument | |
Components of Interest Expense | Year Ended December 31, (in thousands) 2022 2021 2020 Stated coupon interest $ 2,050 $ 8,200 $ 8,200 Amortization of debt discount and debt issuance costs 521 1,966 1,791 Total interest expense $ 2,571 $ 10,166 $ 9,991 |
2025 Term Loan | |
Debt Instrument | |
Components of Interest Expense | Year Ended December 31, (in thousands) 2022 2021 2020 Stated coupon interest $ 154 $ 7,034 $ 7,053 Amortization of debt discount and debt issuance costs 16 1,032 818 Total interest expense $ 170 $ 8,066 $ 7,871 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies. | |
Schedule of Non-cancelable Contractual Obligations | Year ending December 31, (in thousands) 2023 $ 53,652 2024 13,724 2025 1,128 2026 260 Total obligations $ 68,764 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Leases | |
Schedule of Balance Sheet Classification of Lease Assets and Liabilities | (in thousands) December 31, Assets Balance Sheet Classification 2022 2021 Operating leases Other assets, non-current $ 5,690 $ 8,193 Finance leases Property and equipment, net 2,584 1,220 Total leased assets $ 8,274 $ 9,413 (in thousands) December 31, Liabilities Balance Sheet Classification 2022 2021 Operating lease liabilities, current Accrued and other current liabilities $ 3,127 $ 2,751 Operating lease liabilities, non-current Lease liabilities, non-current 3,628 6,753 Total operating lease liabilities $ 6,755 $ 9,504 Finance lease liabilities, current Accrued and other current liabilities $ 1,191 $ 741 Finance lease liabilities, non-current Lease liabilities, non-current 1,418 498 Total finance lease liabilities $ 2,609 $ 1,239 |
Schedule of maturities of the operating and finance lease liabilities | Year Ended December 31, (in thousands) 2022 2021 2020 Cash paid for amounts included in measurement of lease liabilities: Operating cash flows from operating leases $ 3,401 $ 3,435 $ 3,217 Operating cash flows from finance leases $ 155 $ 81 $ 53 Financing cash flows from finance leases $ 1,228 $ 672 $ 388 Right-of-use assets obtained in exchange for lease obligations: Operating leases $ — $ 434 $ 1,388 Finance leases $ 2,694 $ 477 $ 1,817 As of December 31, 2022, the maturities of the lease liabilities were as follows: Year ending December 31, (in thousands) Operating leases Finance leases 2023 $ 3,560 $ 1,354 2024 3,014 1,026 2025 412 481 2026 292 — 2027 and thereafter 124 — Total lease payments 7,402 2,861 Less imputed interest (647) (252) Lease liabilities $ 6,755 $ 2,609 |
Other information related to lease term and discount rate | December 31, 2022 2021 Weighted-Average Remaining Lease Term Operating leases 2.2 years 3.2 years Finance leases 2.2 years 1.7 years Weighted-Average Discount Rate Operating leases 8.0% 8.0% Finance leases 8.4% 5.8% |
Components of lease expense | Year Ended December 31, (in thousands) 2022 2021 2020 Finance lease cost Amortization of right-of-use assets $ 1,228 $ 707 $ 368 Interest on lease liabilities 166 82 57 Total finance lease cost 1,394 789 425 Operating lease cost 3,154 3,066 3,126 Total lease cost $ 4,548 $ 3,855 $ 3,551 |
Supplemental cash flow information related to leases | Year Ended December 31, (in thousands) 2022 2021 2020 Cash paid for amounts included in measurement of lease liabilities: Operating cash flows from operating leases $ 3,401 $ 3,435 $ 3,217 Operating cash flows from finance leases $ 155 $ 81 $ 53 Financing cash flows from finance leases $ 1,228 $ 672 $ 388 Right-of-use assets obtained in exchange for lease obligations: Operating leases $ — $ 434 $ 1,388 Finance leases $ 2,694 $ 477 $ 1,817 |
Schedule of Maturities of Operating Lease Liabilities | Year ending December 31, (in thousands) Operating leases Finance leases 2023 $ 3,560 $ 1,354 2024 3,014 1,026 2025 412 481 2026 292 — 2027 and thereafter 124 — Total lease payments 7,402 2,861 Less imputed interest (647) (252) Lease liabilities $ 6,755 $ 2,609 |
Stock-Based Compensation and _2
Stock-Based Compensation and Employee Benefits (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Stock-Based Compensation and Employee Benefits | |
Summary of Option Activities under 2016 and 2014 Plans | Options Weighted- Average Aggregate Weighted- Remaining Intrinsic Number of Average Contractual Terms Value Options Exercise Price (Years) (in thousands) Outstanding at December 31, 2021 19,959,815 $ 15.89 Granted - at fair value 4,685,750 $ 12.09 Exercised (141,897) $ 4.88 Forfeited/Canceled (2,812,347) $ 16.97 Outstanding at December 31, 2022 21,691,321 $ 15.00 6.0 $ 10,714 Exercisable at December 31, 2022 15,027,783 $ 15.47 4.8 $ 9,647 |
Schedule of options outstanding and exercisable | Information on options outstanding and exercisable as of December 31, 2022 is summarized as follows: Options Outstanding Options Exercisable Weighted- Average Weighted- Weighted- Remaining Average Average Number Contractual Terms Exercise Number Exercise Range of Exercise Prices Outstanding (Years) Price Exercisable Price $ 1.42 - $ 10.05 4,801,972 5.2 $ 6.64 3,223,663 $ 5.99 $ 10.78 - $ 14.13 4,598,418 6.4 $ 12.72 3,381,021 $ 12.67 $ 14.30 - $ 17.17 4,857,557 7.2 $ 15.91 2,530,714 $ 16.08 $ 17.30 - $ 19.07 4,406,311 6.9 $ 17.93 3,000,465 $ 17.94 $ 19.19 - $ 36.85 3,027,063 3.4 $ 25.98 2,891,920 $ 26.22 21,691,321 6.0 $ 15.00 15,027,783 $ 15.47 |
Schedule of additional information on options | Year Ended December 31, (in thousands, except weighted-average grant date fair values) 2022 2021 2020 Total intrinsic value of options exercised $ 914 $ 9,726 $ 14,572 Total grant date fair value of options vested $ 34,916 $ 40,365 $ 34,090 Weighted-average grant date fair value of options granted $ 7.04 $ 9.80 $ 10.94 |
Summary of RSU Activity, under 2014 Plan | RSUs Outstanding Weighted-Average Number of Grant Date Fair RSUs Value Balances at December 31, 2021 1,843,732 $ 17.00 RSUs granted 1,686,875 $ 13.34 RSUs vested (806,854) $ 16.85 RSUs canceled (390,446) $ 15.43 Balances at December 31, 2022 2,333,307 $ 14.66 |
Schedule of Stock-Based Compensation Expense | Year Ended December 31, (in thousands) 2022 2021 2020 Cost of goods sold (1) $ 736 $ 1,099 $ 583 Research and development 18,999 18,688 13,837 Selling, general and administrative 31,002 31,577 23,740 Stock-based compensation expense $ 50,737 $ 51,364 $ 38,160 Stock-based compensation expense capitalized into inventory $ 1,187 $ 1,025 $ 1,460 (1) Stock-based compensation capitalized into inventory is recognized as cost of goods sold 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, 2022 2021 2020 Expected term (years) Stock options 6.1 6.1 6.1 ESPP 0.5 0.5 0.5 Expected volatility Stock options 62 % 65 % 68 % ESPP 70 % 42 % 58 % Risk-free interest rate Stock options 2.37 % 0.89 % 1.09 % ESPP 3.77 % 0.06 % 0.13 % Expected dividend yield Stock options — % — % — % ESPP — % — % — % |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Income Taxes | |
Components of Income (Loss) Before Income Taxes | Year Ended December 31, (in thousands) 2022 2021 2020 Domestic $ (291,746) $ (287,058) $ 133,615 Foreign (8) (42) 2,092 Total $ (291,754) $ (287,100) $ 135,707 |
Schedule of Provision For (Benefit From) Income Taxes | Year Ended December 31, (in thousands) 2022 2021 2020 Current: Federal $ — $ — $ — State — — 3,463 Foreign — — — Subtotal $ — $ — $ 3,463 Deferred: Federal $ — $ — $ — State — — — Foreign — — — Subtotal $ — $ — $ — Provision for income taxes $ — $ — $ 3,463 |
Reconciliation of Statutory U.S. Federal Rate | Year Ended December 31, 2022 2021 2020 Percent of pre-tax income: United States federal statutory income tax rate 21.0 % 21.0 % 21.0 % State taxes, net of federal benefit 1.7 2.6 2.0 Foreign rate differences — — (0.3) Permanent items (0.1) 0.2 0.4 Research and development credit 1.8 2.6 (4.8) Stock-based compensation costs (2.3) (1.2) 1.3 Other — — (0.3) Change in valuation allowance (22.1) (25.2) (16.7) Effective income tax rate — % — % 2.6 % |
Components of Net Deferred Tax Assets | December 31, (in thousands) 2022 2021 Net operating loss carryforwards $ 131,423 $ 117,793 Research and development credits 63,164 58,039 Depreciation and amortization 51,877 40,620 Stock-based compensation 32,561 30,565 Sales related accruals 23,864 17,299 Other accruals 19,717 11,798 Capitalized research and development 17,673 — Gross deferred tax assets 340,279 276,114 Right-of-use asset (1,903) (2,167) In-process research and development (603) (603) Gross deferred tax liabilities (2,506) (2,770) Total net deferred tax asset 337,773 273,344 Less valuation allowance (337,773) (273,344) Net deferred tax assets $ — $ — |
Reconciliation of Unrecognized Tax Benefits | Year Ended December 31, (in thousands) 2022 2021 2020 Balance at beginning of year $ 15,495 $ 13,243 $ 11,603 Additions based on tax positions related to current year 1,385 2,038 1,749 Additions (reductions) for tax positions of prior years (42) 214 (109) Balance at end of year $ 16,838 $ 15,495 $ 13,243 |
Net (Loss) Income Per Share (Ta
Net (Loss) Income Per Share (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Net (Loss) Income Per Share | |
Computation of Basic and Diluted Net (loss) Income Per Share | Year Ended December 31, (in thousands, except share and per share data) 2022 2021 2020 Basic net (loss) income per share Numerator: Net (loss) income $ (291,754) $ (287,100) $ 132,244 Denominator: Weighted-average common shares outstanding 77,630,020 75,449,632 71,411,705 Basic net (loss) income per share $ (3.76) $ (3.81) $ 1.85 Diluted net (loss) income per share Numerator: Net (loss) income $ (291,754) $ (287,100) $ 132,244 Add interest expense on 2026 Convertible Notes, net of tax — — 3,307 Numerator for diluted net (loss) income per share (291,754) (287,100) 135,551 Denominator: Denominator for basic net (loss) income per share 77,630,020 75,449,632 71,411,705 Add effect of potential dilutive securities: Stock options, including shares subject to ESPP — — 3,455,646 Restricted stock units — — 167,597 Shares issuable upon conversion of convertible notes — — 8,456,950 Denominator for diluted net (loss) income per share 77,630,020 75,449,632 83,491,898 Diluted net (loss) income per share $ (3.76) $ (3.81) $ 1.62 |
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: Year Ended December 31, 2022 2021 2020 Stock options, including shares subject to ESPP 22,214,875 19,895,097 9,521,403 Restricted stock units 2,399,465 1,811,607 7,689 Shares issuable upon conversion of 2022 Convertible Notes 1,078,632 4,473,871 4,473,871 Shares issuable upon conversion of 2026 Convertible Notes 11,942,152 11,942,152 — Total 37,635,124 38,122,727 14,002,963 |
Organization and Significant _4
Organization and Significant Accounting Policies - Organization (Details) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 product item | Dec. 31, 2021 USD ($) | |
Organization and Significant Accounting Policies | ||
Product pipeline, number of product candidates | product | 3 | |
Number of reportable and operating segments | item | 1 | |
Investments in marketable securities | $ | $ 0 |
Organization and Significant _5
Organization and Significant Accounting Policies - Cash, Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Organization and Significant Accounting Policies | ||||
Cash and cash equivalents | $ 63,547 | $ 417,195 | $ 541,158 | $ 177,668 |
Restricted cash, non-current | 440 | 440 | 440 | 240 |
Total cash, cash equivalents and restricted cash | $ 63,987 | $ 417,635 | $ 541,598 | $ 177,908 |
Organization and Significant _6
Organization and Significant Accounting Policies - Investments in Marketable Securities (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Organization and Significant Accounting Policies | |||
Interest income from marketable securities | $ 1,900,000 | $ 1,400,000 | $ 600,000 |
Impairments related to credit losses | $ 0 | $ 0 | $ 0 |
Organization and Significant _7
Organization and Significant Accounting Policies - Inventory (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | ||
Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Organization and Significant Accounting Policies | ||||
Inventory write-offs, net | $ 26,000 | $ 26,000 | $ 5,133 | $ 2,171 |
Estimate increased the net loss, amount | $ 26,000 | |||
Estimated net loss per share (basic and diluted) | $ 0.33 |
Organization and Significant _8
Organization and Significant Accounting Policies - Property and Equipment (Details) | 12 Months Ended |
Dec. 31, 2022 | |
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 _9
Organization and Significant Accounting Policies - Goodwill, Intangible Assets and Impairment of Long-lived Assets (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Acquired Finite-Lived Intangible Assets [Line Items] | |||
Goodwill and intangible assets | $ 5,931,000 | $ 3,563,000 | |
Goodwill | 900,000 | 900,000 | |
Impairment of goodwill | 0 | 0 | $ 0 |
Finite-Lived Intangible Assets, Net | $ 2,400,000 | ||
Finite-Lived Intangible Asset, Useful Life | 10 years | ||
Long lived assets, material impairments | $ 0 | 0 | 0 |
In-process research and development | |||
Acquired Finite-Lived Intangible Assets [Line Items] | |||
Goodwill and intangible assets | 2,600,000 | 2,600,000 | |
Impairment of intangible assets excluding goodwill | $ 0 | $ 0 | $ 0 |
Organization and Significant_10
Organization and Significant Accounting Policies - Net Revenues (Details) | 12 Months Ended |
Dec. 31, 2022 | |
Revenue, Performance Obligation, Description of Payment Terms | Payment terms differ by jurisdiction and customer, but payment terms typically range from 30 to approximately 90 days from date of shipment and may be extended during the launch period of a new product. |
Maximum | |
Payment terms from date of shipment, period | 90 days |
Minimum | |
Payment terms from date of shipment, period | 30 days |
Organization and Significant_11
Organization and Significant Accounting Policies - Cost of Goods Sold (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||
Nov. 04, 2019 | Jul. 01, 2019 | May 02, 2019 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Cost of Goods Sold | |||||||
Royalty payment term | 5 years | ||||||
Inventory write-offs, net | $ 26,000 | $ 26,000 | $ 5,133 | $ 2,171 | |||
Bioeq IP AG | |||||||
Cost of Goods Sold | |||||||
Percentage of gross profits shared | 50% | 50% |
Organization and Significant_12
Organization and Significant Accounting Policies - Selling, General and Administrative Expense (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Organization and Significant Accounting Policies | |||
Advertising expenses | $ 10.5 | $ 8.7 | $ 3.8 |
Organization and Significant_13
Organization and Significant Accounting Policies - Operating and Finance Leases (Details) | Dec. 31, 2022 |
Organization and Significant Accounting Policies | |
Term of leases | 36 months |
Revenue - Additional Informatio
Revenue - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Concentration of Revenue [Line Items] | |||
Net revenue | $ 211,042 | $ 326,551 | $ 475,824 |
Total net product revenue | |||
Concentration of Revenue [Line Items] | |||
Net revenue | $ 210,760 | $ 326,509 | $ 475,824 |
Revenue - net revenue (Details)
Revenue - net revenue (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Disaggregation of Revenue [Line Items] | |||
Net revenue | $ 211,042 | $ 326,551 | $ 475,824 |
Total net product revenue | |||
Disaggregation of Revenue [Line Items] | |||
Net revenue | 210,760 | 326,509 | 475,824 |
UDENYCA | |||
Disaggregation of Revenue [Line Items] | |||
Net revenue | 203,814 | 326,509 | $ 475,824 |
CIMERLI | |||
Disaggregation of Revenue [Line Items] | |||
Net revenue | 6,946 | ||
Other | |||
Disaggregation of Revenue [Line Items] | |||
Net revenue | $ 282 | $ 42 |
Revenue - Gross Revenues by Sig
Revenue - Gross Revenues by Significant Customer as a Percentage of Total Gross Revenues (Details) - Net Product Revenue - Customer Concentration Risk | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
McKesson | |||
Concentration Risk | |||
Percentage of total gross revenue | 38% | 39% | 38% |
AmeriSource-Bergen Corp | |||
Concentration Risk | |||
Percentage of total gross revenue | 44% | 39% | 37% |
Cardinal | |||
Concentration Risk | |||
Percentage of total gross revenue | 17% | 20% | 23% |
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, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Accounts Notes And Loans Receivable | |||
Activities and reserve balance, beginning balance | $ 109,723 | $ 123,398 | $ 87,147 |
Provision related to sales made in: | |||
Current period | 578,699 | 679,199 | 692,564 |
Prior period | (3,108) | (11,407) | (11,062) |
Payments and customer credits issued | (584,811) | (681,467) | (645,251) |
Activities and reserve balance, ending balance | 100,503 | 109,723 | 123,398 |
Chargebacks and Discounts for Prompt Payment | |||
Accounts Notes And Loans Receivable | |||
Activities and reserve balance, beginning balance | 29,665 | 40,580 | 35,159 |
Provision related to sales made in: | |||
Current period | 436,865 | 470,791 | 462,328 |
Prior period | (2,090) | (2,876) | (1,336) |
Payments and customer credits issued | (421,763) | (478,830) | (455,571) |
Activities and reserve balance, ending balance | 42,677 | 29,665 | 40,580 |
Rebates | |||
Accounts Notes And Loans Receivable | |||
Activities and reserve balance, beginning balance | 54,004 | 54,058 | 27,494 |
Provision related to sales made in: | |||
Current period | 68,399 | 113,705 | 115,864 |
Prior period | (1,050) | (4,976) | (3,438) |
Payments and customer credits issued | (82,640) | (108,783) | (85,862) |
Activities and reserve balance, ending balance | 38,713 | 54,004 | 54,058 |
Other Fees, Co-pay Assistance and Returns | |||
Accounts Notes And Loans Receivable | |||
Activities and reserve balance, beginning balance | 26,054 | 28,760 | 24,494 |
Provision related to sales made in: | |||
Current period | 73,435 | 94,703 | 114,372 |
Prior period | 32 | (3,555) | (6,288) |
Payments and customer credits issued | (80,408) | (93,854) | (103,818) |
Activities and reserve balance, ending balance | $ 19,113 | $ 26,054 | $ 28,760 |
Fair Value Measurements - Finan
Fair Value Measurements - Financial Assets Measured on a Recurring Basis (Details) - Fair Value Measurements Recurring Basis $ in Thousands | Dec. 31, 2022 USD ($) |
Financial assets measured at fair value on a recurring basis | |
Total financial assets | $ 191,645 |
Level 1 | |
Financial assets measured at fair value on a recurring basis | |
Total financial assets | 143,442 |
Level 2 | |
Financial assets measured at fair value on a recurring basis | |
Total financial assets | 48,203 |
U.S. government agency securities | |
Financial assets measured at fair value on a recurring basis | |
Total financial assets | 19,964 |
U.S. government agency securities | Level 1 | |
Financial assets measured at fair value on a recurring basis | |
Total financial assets | 19,964 |
US Treasury Securities | |
Financial assets measured at fair value on a recurring basis | |
Total financial assets | 68,418 |
US Treasury Securities | Level 1 | |
Financial assets measured at fair value on a recurring basis | |
Total financial assets | 68,418 |
Commercial paper and corporate notes | |
Financial assets measured at fair value on a recurring basis | |
Total financial assets | 48,203 |
Commercial paper and corporate notes | Level 2 | |
Financial assets measured at fair value on a recurring basis | |
Total financial assets | 48,203 |
Money market funds | |
Financial assets measured at fair value on a recurring basis | |
Total financial assets | 55,060 |
Money market funds | Level 1 | |
Financial assets measured at fair value on a recurring basis | |
Total financial assets | $ 55,060 |
Fair Value Measurements - Cost,
Fair Value Measurements - Cost, Unrealized Gains or Losses, and Fair Value by Investment Type (Details) $ in Thousands | Dec. 31, 2022 USD ($) |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |
Cost | $ 191,623 |
Unrealized Gain | 43 |
Unrealized (Loss) | (21) |
Fair Value | 191,645 |
Money Market Funds [Member] | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |
Cost | 55,060 |
Fair Value | 55,060 |
U.S. government agency securities | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |
Cost | 19,929 |
Unrealized Gain | 35 |
Fair Value | 19,964 |
US Treasury Securities | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |
Cost | 68,431 |
Unrealized Gain | 8 |
Unrealized (Loss) | (21) |
Fair Value | 68,418 |
Commercial paper and corporate notes | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |
Cost | 48,203 |
Fair Value | $ 48,203 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) | 12 Months Ended | ||
Dec. 31, 2022 USD ($) position | Dec. 31, 2021 USD ($) | Dec. 31, 2020 USD ($) | |
Fair Value Measurements | |||
Long lived assets, material impairments | $ 0 | $ 0 | $ 0 |
Positions that were in unrealized loss positions | position | 13 | ||
Remaining contractual maturities of available-for-sale securities | 1 year | ||
Average maturity of investments upon acquisition | 7 months | ||
Investments in marketable securities | 0 | ||
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 | ||
Unrealized Gain (Loss) on Securities | $ 0 |
Inventory (Details)
Inventory (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Inventory | ||
Raw materials | $ 10,262 | $ 4,870 |
Work in process | 86,712 | 65,117 |
Finished goods | 18,077 | 23,265 |
Total | $ 115,051 | $ 93,252 |
Inventory - Balance Sheet Class
Inventory - Balance Sheet Classifications (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Inventory | ||
Inventory | $ 38,791 | $ 37,642 |
Inventory, non-current | 76,260 | 55,610 |
Total | $ 115,051 | $ 93,252 |
Inventory - Additional Informat
Inventory - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | ||
Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Inventory [Line Items] | ||||
Inventory write-offs, net | $ 26,000 | $ 26,000 | $ 5,133 | $ 2,171 |
Estimate increased the net loss, amount | $ 26,000 | |||
Estimated net loss per share (basic and diluted) | $ 0.33 | |||
Prepayment made for manufacturing services | $ 17,880 | 13,666 | ||
Inventory | 38,791 | 37,642 | ||
Impairment charge within research and development expenses | 3,210 | |||
Impairment charge for the write-off of prepaid manufacturing services no longer deemed to have future benefits | 3,200 | |||
Research and development | 199,358 | 363,105 | $ 142,759 | |
Prepayments made to a CMO for manufacturing services for UDENYCA | 13,000 | 8,300 | ||
Prepayments made to a CMO For Other Research And Development Pipeline Program | 4,900 | 5,400 | ||
Yusimry Product [Member] | ||||
Inventory [Line Items] | ||||
Inventory | $ 23,700 | |||
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, 2022 | Dec. 31, 2021 |
Property and Equipment, Net | ||
Total property and equipment | $ 28,911 | $ 24,662 |
Accumulated depreciation and amortization | (20,157) | (16,849) |
Property and equipment, net | 8,754 | 7,813 |
Machinery and Equipment | ||
Property and Equipment, Net | ||
Total property and equipment | 12,944 | 11,876 |
Computer Equipment and Software | ||
Property and Equipment, Net | ||
Total property and equipment | 3,183 | 3,033 |
Furniture and Fixtures | ||
Property and Equipment, Net | ||
Total property and equipment | 1,258 | 1,129 |
Leasehold Improvements | ||
Property and Equipment, Net | ||
Total property and equipment | 6,198 | 5,942 |
Finance lease right of use assets | ||
Property and Equipment, Net | ||
Total property and equipment | 4,632 | 2,294 |
Construction in Progress | ||
Property and Equipment, Net | ||
Total property and equipment | $ 696 | $ 388 |
Balance Sheet Components - Addi
Balance Sheet Components - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Balance Sheet Components | |||
Depreciation and amortization expense related to property and equipment | $ 3,600 | $ 3,500 | $ 2,900 |
Material impairments of property and equipment | 0 | 0 | $ 0 |
Software implementation costs | $ 3,500 | $ 1,300 |
Balance Sheet Components - Accr
Balance Sheet Components - Accrued and Other Current Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Balance Sheet Components | ||
Accrued manufacturing and clinical | $ 21,774 | $ 30,541 |
Accrued co-development costs for toripalimab | 8,356 | 1,926 |
Lease liabilities, current | 15,649 | 12,168 |
Accrued other | 4,318 | 3,492 |
Total Accrued and other current liabilities | $ 50,097 | $ 48,127 |
Collaborations and Other Arra_2
Collaborations and Other Arrangements (Details) $ / shares in Units, $ in Thousands, € in Millions | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||||||||||||
Apr. 16, 2021 USD ($) $ / shares shares | Feb. 01, 2021 USD ($) | Jan. 13, 2020 USD ($) | Nov. 04, 2019 EUR (€) | May 02, 2019 | Mar. 31, 2022 USD ($) | Mar. 31, 2021 USD ($) | Dec. 31, 2022 USD ($) $ / shares | Dec. 31, 2022 EUR (€) | Dec. 31, 2021 USD ($) $ / shares | Dec. 31, 2020 USD ($) | Dec. 31, 2019 USD ($) | Dec. 31, 2019 EUR (€) | Dec. 30, 2022 $ / shares | Jun. 30, 2021 USD ($) | Apr. 14, 2020 $ / shares | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions | ||||||||||||||||
Additional milestone payments related to FDA approval | $ 25,000 | |||||||||||||||
Research and development | 199,358 | $ 363,105 | $ 142,759 | |||||||||||||
Accounts payable | 11,526 | 16,159 | ||||||||||||||
Accrued and other current liabilities | 50,097 | $ 48,127 | ||||||||||||||
Collaboration agreement, threshold royalty payments | $ 2,900 | |||||||||||||||
License Agreement Fee | $ 35,000 | |||||||||||||||
Common Stock Par Or Stated Value Per Share | $ / shares | $ 0.0001 | $ 0.0001 | ||||||||||||||
Share Price | $ / shares | $ 7.92 | $ 14.82 | ||||||||||||||
Finite-Lived Intangible Asset, Useful Life | 10 years | 10 years | ||||||||||||||
Bioeq IP AG | ||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | ||||||||||||||||
Initial term of agreement | 10 years | |||||||||||||||
Percentage of gross profits shared | 50% | 50% | ||||||||||||||
Bioeq IP AG | Licensed Products | ||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | ||||||||||||||||
Maximum aggregate milestone payments | € | € 12.5 | |||||||||||||||
Additional milestone payments related to FDA approval | € | € 2.5 | |||||||||||||||
Bioeq IP AG | Research and Development Expense [Member] | ||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | ||||||||||||||||
Upfront and milestone payment | $ 11,100 | € 10 | ||||||||||||||
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. | Research and Development Expense [Member] | Bevacizumab Licensed Product | ||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | ||||||||||||||||
Research and development | $ 1,100 | 7,500 | ||||||||||||||
Collaboration Agreement | ||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | ||||||||||||||||
License Agreement Fee | $ 35,000 | |||||||||||||||
Collaboration Agreement | Anti-TIGIT Antibody and IL-2 cytokine | ||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | ||||||||||||||||
Collaboration Agreement , Maximum Payments On Attainment Of Certain Sales Thresholds For Each Option Program | $ 170,000 | |||||||||||||||
Junshi Biosciences | ||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | ||||||||||||||||
Maximum paid amount for co-development activities (per licensed compound) | $ 25,000 | |||||||||||||||
License Agreement Fee | $ 35,000 | |||||||||||||||
Collaboration agreement, royalty on net sales for each exercised option, percentage | 18% | |||||||||||||||
Collaboration agreement, Maximum aggregate one-time payment for achievement of milestones, for each option program | $ 85,000 | |||||||||||||||
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 | Accrued and other current liabilities | ||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | ||||||||||||||||
Co-development, regulatory and technology transfer costs | 8,400 | 1,900 | ||||||||||||||
Junshi Biosciences | Toripalimab | ||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | ||||||||||||||||
Collaboration Agreement, upfront amount paid | $ 150,000 | |||||||||||||||
Collaboration agreement, royalty on net sales, percentage | 20% | |||||||||||||||
Collaboration agreement, threshold royalty payments | $ 380,000 | |||||||||||||||
Fair value for the discount for lack of marketability (DLOM) | $ 9,000 | |||||||||||||||
Junshi Biosciences | Research and Development Expense [Member] | ||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | ||||||||||||||||
Research and development | $ 68,500 | $ 175,400 | $ 5,000 | |||||||||||||
Junshi Biosciences | Research and Development Expense [Member] | Toripalimab | ||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | ||||||||||||||||
Upfront payment for the exclusive rights | $ 145,000 |
Debt Obligations - Summary of D
Debt Obligations - Summary of Debt Obligations (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
2027 Term Loans | Level 2 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Principal amount | $ 250,000 | |
Unamortized debt discount and debt issuance costs | (4,517) | |
Net carrying value | 245,483 | |
Estimated fair value | 245,483 | |
1.5% Convertible Senior Subordinated Notes due 2026 | Level 2 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Principal amount | 230,000 | $ 230,000 |
Unamortized debt discount and debt issuance costs | (4,425) | (5,712) |
Net carrying value | 225,575 | 224,288 |
Estimated fair value | 157,205 | 271,860 |
8.2% Convertible Notes due 2022 | Level 2 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Principal amount | 109,000 | |
Unamortized debt discount and debt issuance costs | (521) | |
Net carrying value | 108,479 | |
Estimated fair value | 108,361 | |
2025 Term Loan | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Net carrying value | $ 0 | |
2025 Term Loan | Level 2 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Principal amount | 75,000 | |
Unamortized debt discount and debt issuance costs | 513 | |
Net carrying value | 75,513 | |
Estimated fair value | $ 75,513 |
Debt Obligations - 2027 Term Lo
Debt Obligations - 2027 Term Loan - Narrative (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||||
Mar. 31, 2022 USD ($) | Jan. 31, 2022 USD ($) | Dec. 31, 2022 USD ($) | Dec. 31, 2022 USD ($) | Sep. 14, 2022 USD ($) | Jan. 05, 2022 USD ($) tranche | Apr. 30, 2020 USD ($) | Feb. 29, 2016 USD ($) | |
Debt Instrument [Line Items] | ||||||||
Outstanding amount paid off | $ 81,750 | |||||||
Outstanding amount payoff | $ 109,000 | |||||||
2027 Term Loans | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt Instrument, Interest Rate During Period | 12% | |||||||
2027 Term Loans | Secured Overnight Financing Rate (SOFR) Overnight Index Swap Rate [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Spread on variable rate | 1% | |||||||
Debt Instrument, Interest Rate During Period | 0.26161% | |||||||
2027 Term Loans | BioPharma Credit Investments V GP LLC | ||||||||
Debt Instrument [Line Items] | ||||||||
Principal amount | $ 300,000 | |||||||
Number of tranches | tranche | 4 | |||||||
Net carrying value | $ 245,483 | $ 245,483 | ||||||
Loan agreement covenants, minimum trailing twelve month net sales for current quarter | $ 200,000 | |||||||
Loan agreement covenants, minimum trailing twelve month net sales for the quarter ended March 30, 2024 | 210,000 | |||||||
Loan agreement covenants, minimum trailing twelve-month net sales for the quarter ended June 30, 2024 | 230,000 | |||||||
Loan agreement covenants, minimum trailing twelve-month net sales for the quarter ended September 30, 2024 | 270,000 | |||||||
Loan agreement covenants, minimum trailing twelve-month net sales for the quarter ended December 31, 2024 and thereafter | $ 300,000 | |||||||
Mandatory prepayment term | 10 days | |||||||
Debt discounts and issuance costs | $ 6,800 | |||||||
Remaining unamortized debt discount and debt offering costs | $ 4,517 | $ 4,517 | ||||||
2027 Term Loans | BioPharma Credit Investments V GP LLC | Three-month LIBOR | ||||||||
Debt Instrument [Line Items] | ||||||||
Spread on variable rate | 1% | |||||||
2027 Term Loans | Additional facility amount | BioPharma Credit Investments V GP LLC | ||||||||
Debt Instrument [Line Items] | ||||||||
Uncommitted additional facility | $ 100,000 | |||||||
2027 Term Loans | Through March 31, 2023 | BioPharma Credit Investments V GP LLC | ||||||||
Debt Instrument [Line Items] | ||||||||
Stated interest rate | 8.25% | |||||||
2027 Term Loans | Starting April 1, 2023 | ||||||||
Debt Instrument [Line Items] | ||||||||
Stated interest rate | 8.25% | 8.25% | ||||||
Tranche A Loan, funded January 5, 2022 | BioPharma Credit Investments V GP LLC | ||||||||
Debt Instrument [Line Items] | ||||||||
Principal amount | $ 100,000 | |||||||
Debt discounts and issuance costs | $ 7,800 | |||||||
Tranche B Loan, funded no later than April 1, 2022 | BioPharma Credit Investments V GP LLC | ||||||||
Debt Instrument [Line Items] | ||||||||
Principal amount | $ 100,000 | |||||||
Debt discounts and issuance costs | 2,300 | |||||||
Convertible notes, Issuance Cost | 1,000 | |||||||
Tranche C Loan, funded between April 1, 2022 and March 17, 2023 | BioPharma Credit Investments V GP LLC | ||||||||
Debt Instrument [Line Items] | ||||||||
Amount not funded | 50,000 | |||||||
Tranche D Loan, funded on September 14, 2022 | BioPharma Credit Investments V GP LLC | ||||||||
Debt Instrument [Line Items] | ||||||||
Principal amount | $ 50,000 | |||||||
Convertible notes, Issuance Cost | $ 500 | |||||||
1.5% Convertible Senior Subordinated Notes due 2026 | Convertible Notes | ||||||||
Debt Instrument [Line Items] | ||||||||
Principal amount | $ 230,000 | |||||||
Net carrying value | $ 225,575 | $ 225,575 | ||||||
Stated interest rate | 1.50% | |||||||
Remaining unamortized debt discount and debt offering costs | $ 4,425 | $ 4,425 | ||||||
Total term of the loan | 3 years 3 months 18 days | |||||||
Effective interest rate | 2.10% | 2.10% | ||||||
1.5% Convertible Senior Subordinated Notes due 2026 | BioPharma Credit Investments V GP LLC | Scenario, Plan | Maximum | ||||||||
Debt Instrument [Line Items] | ||||||||
Principal amount | 50,000 | |||||||
8.2% Convertible Notes due 2022 | Convertible Notes | ||||||||
Debt Instrument [Line Items] | ||||||||
Principal amount | $ 100,000 | |||||||
Stated interest rate | 8.20% | |||||||
Outstanding amount payoff | $ 111,100 | |||||||
Convertible notes, Issuance Cost | $ 800 | |||||||
2025 Term Loan | ||||||||
Debt Instrument [Line Items] | ||||||||
Net carrying value | $ 0 | $ 0 | ||||||
2025 Term Loan | Convertible Notes | ||||||||
Debt Instrument [Line Items] | ||||||||
Outstanding amount paid off | $ 81,900 | |||||||
Tranche A and B Loans | BioPharma Credit Investments V GP LLC | ||||||||
Debt Instrument [Line Items] | ||||||||
Remaining unamortized debt discount and debt offering costs | $ 4,500 | $ 4,500 | ||||||
Tranches A, B and D | BioPharma Credit Investments V GP LLC | ||||||||
Debt Instrument [Line Items] | ||||||||
Remaining term | 4 years |
Debt Obligations - 2027 Term _2
Debt Obligations - 2027 Term Loans Interest Expense Components (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Debt Instrument [Line Items] | |||
Amortization of debt discount and debt issuance costs | $ 6,431 | $ 4,257 | $ 3,481 |
2027 Term Loans | BioPharma Credit Investments V GP LLC | |||
Debt Instrument [Line Items] | |||
Amortization of debt discount and debt issuance costs | 4,550 | ||
Total Interest expense | $ 24,793 |
Debt Obligations - 2027 Term _3
Debt Obligations - 2027 Term Loan Future Payments (Details) - 2027 Term Loans - BioPharma Credit Investments V GP LLC $ in Thousands | Dec. 31, 2022 USD ($) |
Debt Instrument [Line Items] | |
2023 - interest only | $ 30,412 |
2024 - interest only | 30,496 |
2025 - interest only | 30,412 |
2026 - principal and interest | 221,231 |
2027 - principal and interest | 50,083 |
Total minimum payments | 362,634 |
Less amount representing interest | (112,634) |
Term Loan, gross | 250,000 |
Less unamortized debt discount and debt issuance costs, net | (4,517) |
Net carrying amount of Term Loans | $ 245,483 |
Debt Obligations - Convertible
Debt Obligations - Convertible Senior Subordinated Notes due 2026 - Narrative (Details) | 1 Months Ended | 12 Months Ended | |||
Apr. 30, 2020 USD ($) $ / shares shares | Dec. 31, 2022 USD ($) item | Dec. 31, 2020 USD ($) | Dec. 30, 2022 $ / shares | Apr. 14, 2020 $ / shares | |
Debt Instrument | |||||
Net proceeds from offering | $ 222,156,000 | ||||
Closing stock, price per share | $ / shares | $ 7.92 | $ 14.82 | |||
1.5% Convertible Senior Subordinated Notes due 2026 | |||||
Debt Instrument | |||||
Number of events in default | item | 0 | ||||
Contractual term | 6 years | ||||
Convertible Notes | 1.5% Convertible Senior Subordinated Notes due 2026 | |||||
Debt Instrument | |||||
Principal amount | $ 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 | ||||
Debt instrument maturity date | Apr. 15, 2026 | ||||
Convertible notes, premium percentage | 30% | ||||
Convertible notes, covenant compliance | As of December 31, 2022, 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 | $ 4,425,000 | ||||
Effective interest rate | 2.10% | ||||
Debt Instrument Term | 3 years 3 months 18 days | ||||
Convertible Notes | 1.5% Convertible Senior Subordinated Notes due 2026 | Scenario, Plan | |||||
Debt Instrument | |||||
Convertible notes, converted amount | $ 94,600,000 |
Debt Obligations - Capped Call
Debt Obligations - Capped Call Transactions - Narrative (Details) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | |||
Apr. 30, 2020 | Apr. 30, 2020 | Dec. 30, 2022 | Apr. 14, 2020 | |
Option Indexed to Issuer's Equity [Line Items] | ||||
Closing stock, price per share | $ 7.92 | $ 14.82 | ||
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. | $ 25.93 | |||
Percentage of cap price | 75% |
Debt Obligations - 2026 Convert
Debt Obligations - 2026 Convertible Notes Interest Expense Components (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Debt Instrument | |||
Amortization of debt discount and debt issuance costs | $ 6,431 | $ 4,257 | $ 3,481 |
1.5% Convertible Senior Subordinated Notes due 2026 | Convertible Notes | |||
Debt Instrument | |||
Stated coupon interest | 3,450 | 3,450 | 2,434 |
Amortization of debt discount and debt issuance costs | 1,286 | 1,259 | 873 |
Total Interest expense | $ 4,736 | $ 4,709 | $ 3,307 |
Debt Obligations - 2026 Conve_2
Debt Obligations - 2026 Convertible Notes Future Payments (Details) - Convertible Notes - 1.5% Convertible Senior Subordinated Notes due 2026 $ in Thousands | Dec. 31, 2022 USD ($) |
Debt Instrument | |
2023 - interest only | $ 3,450 |
2024 - interest only | 3,450 |
2025 - interest only | 3,450 |
2026 and thereafter | 231,725 |
Total minimum payments | 242,075 |
Less amount representing interest | (12,075) |
2026 Convertible Notes, principal amount | 230,000 |
Less unamortized debt discount and debt issuance costs | (4,425) |
Net carrying amount of Term Loans | $ 225,575 |
Debt Obligations - Convertibl_2
Debt Obligations - Convertible Notes due 2022 Narrative (Details) | 1 Months Ended | 12 Months Ended | |||||||
Jan. 07, 2019 USD ($) | Feb. 29, 2016 USD ($) item $ / shares shares | Mar. 31, 2022 USD ($) | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | Dec. 31, 2020 USD ($) | Dec. 30, 2022 $ / shares | Apr. 14, 2020 $ / shares | Jan. 01, 2020 | |
Debt Instrument | |||||||||
Proceeds from issuance of 2026 Convertible Notes, net of issuance costs | $ 222,156,000 | ||||||||
Outstanding amount payoff | $ 109,000,000 | ||||||||
Convertible trading days | item | 15 | ||||||||
Closing stock, price per share | $ / shares | $ 7.92 | $ 14.82 | |||||||
8.2% Convertible Notes due 2022 | |||||||||
Debt Instrument | |||||||||
Interest rate description | The 2022 Convertible Notes bore 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% | ||||||||
2025 Term Loan | |||||||||
Debt Instrument | |||||||||
Net carrying value | 0 | ||||||||
Interest rate description | Starting January 1, 2020, the Borrowings under the 2025 Term Loan bore interest at 6.75% per annum plus three month LIBOR. Interest was payable quarterly in arrears. Under the prospective method to account for future cash payments adopted by the Company, the effective interest rate was not constant, and any change in the expected cash flows was recognized prospectively as an adjustment to the effective yield. | ||||||||
2025 Term Loan | Lender | |||||||||
Debt Instrument | |||||||||
Principal amount | $ 75,000,000 | ||||||||
Stated interest rate | 6.75% | ||||||||
Interest expense | 170,000 | $ 8,066,000 | 7,871,000 | ||||||
Debt Instrument Term | 6 years | ||||||||
Convertible Notes | KKR Member | |||||||||
Debt Instrument | |||||||||
Principal amount | $ 20,000,000 | ||||||||
Convertible Notes | MX II Member | |||||||||
Debt Instrument | |||||||||
Principal amount | 4,000,000 | ||||||||
Convertible Notes | KMGCP Member | |||||||||
Debt Instrument | |||||||||
Principal amount | 1,000,000 | ||||||||
Convertible Notes | Lender | KKR Member | |||||||||
Debt Instrument | |||||||||
Principal amount | 75,000,000 | ||||||||
Convertible Notes | 8.2% Convertible Notes due 2022 | |||||||||
Debt Instrument | |||||||||
Principal amount | $ 100,000,000 | ||||||||
Stated interest rate | 8.20% | ||||||||
Proceeds from issuance of 2026 Convertible Notes, net of issuance costs | $ 99,200,000 | ||||||||
Convertible notes, Issuance Cost | $ 800,000 | ||||||||
Interest expense | $ 2,571,000 | $ 10,166,000 | $ 9,991,000 | ||||||
Debt instrument maturity date | Mar. 31, 2022 | ||||||||
Outstanding amount payoff | $ 111,100,000 | ||||||||
Convertible Notes Payable | $ 0 | ||||||||
Convertible notes, premium percentage | 9% | 9% | |||||||
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% | ||||||||
Consecutive trading days | item | 30 | ||||||||
Percentage to pay in cash of the par value of notes | 109% | ||||||||
Convertible Notes | 8.2% Convertible Notes due 2022 | Minimum | |||||||||
Debt Instrument | |||||||||
Convertible trading days | item | 20 |
Debt Obligations - 2022 Convert
Debt Obligations - 2022 Convertible Notes Interest Expense Components (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Debt Instrument | |||
Amortization of debt discount and debt issuance costs | $ 6,431 | $ 4,257 | $ 3,481 |
Total interest expense | 32,474 | 22,959 | 21,166 |
8.2% Convertible Notes due 2022 | Convertible Notes | |||
Debt Instrument | |||
Stated coupon interest | 2,050 | 8,200 | 8,200 |
Amortization of debt discount and debt issuance costs | 521 | 1,966 | 1,791 |
Total Interest expense | $ 2,571 | $ 10,166 | $ 9,991 |
Debt Obligations - 2025 Term Lo
Debt Obligations - 2025 Term Loan Interest Expense Components (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Debt Instrument | |||
Amortization of debt discount and debt issuance costs | $ 6,431 | $ 4,257 | $ 3,481 |
Lender | 2025 Term Loan | |||
Debt Instrument | |||
Amortization of debt discount and debt issuance costs | 16 | 1,032 | 818 |
Total Interest expense | $ 170 | $ 8,066 | $ 7,871 |
Debt Obligations - 2025 Term _2
Debt Obligations - 2025 Term Loan - Narrative (Details) - USD ($) | 1 Months Ended | 12 Months Ended | ||
Jan. 07, 2019 | Jan. 31, 2022 | Dec. 31, 2022 | Jan. 01, 2020 | |
Debt Instrument | ||||
Outstanding amount paid off | $ 81,750,000 | |||
Loss on debt extinguishment | $ (6,222,000) | |||
2025 Term Loan | ||||
Debt Instrument | ||||
Interest rate description | Starting January 1, 2020, the Borrowings under the 2025 Term Loan bore interest at 6.75% per annum plus three month LIBOR. Interest was payable quarterly in arrears. Under the prospective method to account for future cash payments adopted by the Company, the effective interest rate was not constant, and any change in the expected cash flows was recognized prospectively as an adjustment to the effective yield. | |||
2025 Term Loan | Paid on or Prior to the Three Year Anniversary of Closing Date | ||||
Debt Instrument | ||||
Effective interest rate | 5% | |||
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% | |||
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 | |||
Principal amount | $ 75,000,000 | |||
Outstanding amount paid off | $ 81,900,000 | |||
Stated interest rate | 6.75% | |||
Prepayment premium percentage | 5% | |||
Payment of closing fee to the lenders in form of origination issue discount | $ 1,100,000 | |||
Percentage required to pay an additional exit fee on principal amount | 4% | 4% | ||
Loss on debt extinguishment | $ 6.2 |
Commitments and Contingencies -
Commitments and Contingencies - Schedule of Non-Cancelable Contractual Obligations (Details) $ in Thousands | Dec. 31, 2022 USD ($) |
Commitments and Contingencies. | |
2023 | $ 53,652 |
2024 | 13,724 |
2025 | 1,128 |
2026 | 260 |
Total obligations | $ 68,764 |
Commitments and Contingencies_2
Commitments and Contingencies - Additional Information (Details) - USD ($) $ in Millions | 1 Months Ended | ||
Jul. 01, 2019 | Apr. 30, 2022 | Dec. 31, 2022 | |
Contractual Obligation Fiscal Year Maturity [Abstract] | |||
Royalty payment term | 5 years | ||
Claims related to certain sales of UDENYCA from October 2020 through December 2021 | $ 14 | ||
Established a litigation accrual | $ 4.7 |
Leases - Additional Information
Leases - Additional Information (Details) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2022 USD ($) ft² | Dec. 31, 2021 USD ($) | Dec. 31, 2020 USD ($) | Dec. 31, 2019 item | |
Lessee Lease Description | ||||
Term of leases | 36 months | |||
Operating lease costs | $ | $ 4,548 | $ 3,855 | $ 3,551 | |
Cash paid for amounts included in measurement of lease liabilities | $ | $ 3,401 | $ 3,435 | $ 3,217 | |
Operating lease weighted average remaining term | 2 years 2 months 12 days | 3 years 2 months 12 days | ||
Operating lease Weighted average discount rate | 8% | 8% | ||
Finance lease weighted average remaining term | 2 years 2 months 12 days | 1 year 8 months 12 days | ||
Finance lease Weighted average discount rate | 8.40% | 5.80% | ||
Corporate Headquarters Lease | ||||
Lessee Lease Description | ||||
Area of office space leased | ft² | 47,789 | |||
Lease Expiration Date | Sep. 01, 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 01, 2027 | |||
Option to extend lease | true | |||
Vehicle Lease | ||||
Lessee Lease Description | ||||
Number of vehicles leased | item | 100 | |||
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, 2022 | Dec. 31, 2021 |
Assets: | ||
Operating lease right-of-use assets | $ 5,690 | $ 8,193 |
Operating Lease, Right-of-Use Asset, Statement of Financial Position [Extensible List] | Other Assets Noncurrent | Other Assets Noncurrent |
Finance lease | $ 2,584 | $ 1,220 |
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 | $ 8,274 | $ 9,413 |
Liabilities: | ||
Lease liabilities, current | $ 3,127 | $ 2,751 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | Accrued Liabilities Current | Accrued Liabilities Current |
Operating lease liability noncurrent | $ 3,628 | $ 6,753 |
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 | $ 6,755 | $ 9,504 |
Finance lease liabilities, current | $ 1,191 | $ 741 |
Finance Lease, Liability, Current, Statement of Financial Position [Extensible List] | Accrued Liabilities Current | Accrued Liabilities Current |
Finance lease liabilities, non-current | $ 1,418 | $ 498 |
Finance Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | Other Liabilities Noncurrent | Other Liabilities Noncurrent |
Total finance lease liabilities | $ 2,609 | $ 1,239 |
Leases - Other information rela
Leases - Other information related to lease term and discount rate (Details) | Dec. 31, 2022 | Dec. 31, 2021 |
Leases | ||
Operating lease weighted average remaining term | 2 years 2 months 12 days | 3 years 2 months 12 days |
Finance lease weighted average remaining term | 2 years 2 months 12 days | 1 year 8 months 12 days |
Operating lease Weighted average discount rate | 8% | 8% |
Finance lease Weighted average discount rate | 8.40% | 5.80% |
Leases - Components of lease ex
Leases - Components of lease expense (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Leases | |||
Amortization of right-of-use assets | $ 1,228 | $ 707 | $ 368 |
Interest on lease liabilities | 166 | 82 | 57 |
Total finance lease cost | 1,394 | 789 | 425 |
Operating lease cost | 3,154 | 3,066 | 3,126 |
Total lease cost | $ 4,548 | $ 3,855 | $ 3,551 |
Leases - Supplemental cash flow
Leases - Supplemental cash flow information related to leases (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Leases | |||
Operating cash flows from operating leases | $ 3,401 | $ 3,435 | $ 3,217 |
Operating cash flows from finance leases | 155 | 81 | 53 |
Financing cash flows from finance leases | 1,228 | 672 | 388 |
Operating leases | 434 | 1,388 | |
Finance leases | $ 2,694 | $ 477 | $ 1,817 |
Leases - Schedule of Maturities
Leases - Schedule of Maturities of Operating and Finance Lease Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Operating leases | ||
2023 | $ 3,560 | |
2024 | 3,014 | |
2025 | 412 | |
2026 | 292 | |
2027 and thereafter | 124 | |
Total lease payments | 7,402 | |
Less imputed interest | (647) | |
Total operating lease liabilities | 6,755 | $ 9,504 |
Finance leases | ||
2023 | 1,354 | |
2024 | 1,026 | |
2025 | 481 | |
Total lease payments | 2,861 | |
Less imputed interest | (252) | |
Total finance lease liabilities | $ 2,609 | $ 1,239 |
At-The-Market Offering (Details
At-The-Market Offering (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Nov. 08, 2022 | Jan. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
At-The-Market Offering | ||||
Aggregate offering price | $ 40,903 | |||
Gross proceeds from issuance of common stock | $ 6,700 | |||
At The Market Offering. | ||||
At-The-Market Offering | ||||
Aggregate offering price | $ 150,000 | |||
Common stock, shares issued and sold | 295,200 | 916,884 | ||
Share price | $ 7.41 | $ 7.30 | ||
Gross proceeds from issuance of common stock | $ 2,200 | |||
Common stock, net proceeds | 2,100 | $ 6,500 | ||
Commissions and fees | $ 100 | $ 200 |
Stock-Based Compensation and _3
Stock-Based Compensation and Employee Benefits - Equity Incentive Plans Narrative (Details) | 12 Months Ended | 108 Months Ended |
Dec. 31, 2022 shares | Dec. 31, 2022 shares | |
2014 Plan | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Percentage of shares available for issuance | 4% | |
Common stock reserved for future issuance | 1,252,865 | 1,252,865 |
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 | 861,312 | 861,312 |
Stock-Based Compensation and _4
Stock-Based Compensation and Employee Benefits - Stock Options Narrative (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Feb. 28, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 800 | $ 50,737 | $ 51,364 | $ 38,160 |
Unrecognized stock-based compensation expenses related to stock options | $ 51,500 | |||
Unrecognized share-based compensation related to stock options, RSUs and ESPP, period for recognition | 2 years 8 months 12 days | |||
Employee Stock Option | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Vesting period | 4 years | |||
Options, expiration period | 10 years | |||
Restricted Stock Units | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Unrecognized stock-based compensation expenses related to stock options | $ 20,300 | |||
Unrecognized share-based compensation related to stock options, RSUs and ESPP, period for recognition | 1 year 6 months |
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 $ / shares in Units, $ in Thousands | 12 Months Ended |
Dec. 31, 2022 USD ($) $ / shares shares | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Number of Options, Beginning balance | shares | 19,959,815 |
Number of Options, Granted - at fair value | shares | 4,685,750 |
Number of Options, Exercised | shares | (141,897) |
Number of Options, Forfeited/Canceled | shares | (2,812,347) |
Number of Options, Ending balance | shares | 21,691,321 |
Number of Options, Exercisable | shares | 15,027,783 |
Weighted-Average Exercise Price, Beginning balance | $ / shares | $ 15.89 |
Weighted-Average Exercise Price, Granted - at fair value | $ / shares | 12.09 |
Weighted Average Exercise Price, Exercised | $ / shares | 4.88 |
Weighted Average Exercise Price, Forfeited/Canceled | $ / shares | 16.97 |
Weighted-Average Exercise Price, Ending balance | $ / shares | 15 |
Weighted Average Exercise Price, Exercisable | $ / shares | $ 15.47 |
Options outstanding, Weighted-Average Remaining Contractual Terms | 6 years |
Options outstanding, Weighted-Average Remaining Contractual Terms, Exercisable | 4 years 9 months 18 days |
Options outstanding, Aggregate Intrinsic Value | $ | $ 10,714 |
Options outstanding, Aggregate Intrinsic Value, Exercisable | $ | $ 9,647 |
Stock Based Compensation and _2
Stock Based Compensation and Employee Benefits - Options outstanding and exercisable (Details) - 2016 plan and 2014 plan - $ / shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Options outstanding, Number of Options | 21,691,321 | 19,959,815 |
Options outstanding, Weighted-Average Remaining Contractual Terms | 6 years | |
Options outstanding, Weighted-Average Exercise Price | $ 15 | $ 15.89 |
Number of Options, Exercisable | 15,027,783 | |
Weighted Average Exercise Price, Exercisable | $ 15.47 | |
1.42 - 10.05 | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Exercise price range, Lower | 1.42 | |
Exercise price range, Upper | $ 10.05 | |
Options outstanding, Number of Options | 4,801,972 | |
Options outstanding, Weighted-Average Remaining Contractual Terms | 5 years 2 months 12 days | |
Options outstanding, Weighted-Average Exercise Price | $ 6.64 | |
Number of Options, Exercisable | 3,223,663 | |
Weighted Average Exercise Price, Exercisable | $ 5.99 | |
10.78 - 14.13 | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Exercise price range, Lower | 10.78 | |
Exercise price range, Upper | $ 14.13 | |
Options outstanding, Number of Options | 4,598,418 | |
Options outstanding, Weighted-Average Remaining Contractual Terms | 6 years 4 months 24 days | |
Options outstanding, Weighted-Average Exercise Price | $ 12.72 | |
Number of Options, Exercisable | 3,381,021 | |
Weighted Average Exercise Price, Exercisable | $ 12.67 | |
14.30 - 17.17 | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Exercise price range, Lower | 14.30 | |
Exercise price range, Upper | $ 17.17 | |
Options outstanding, Number of Options | 4,857,557 | |
Options outstanding, Weighted-Average Remaining Contractual Terms | 7 years 2 months 12 days | |
Options outstanding, Weighted-Average Exercise Price | $ 15.91 | |
Number of Options, Exercisable | 2,530,714 | |
Weighted Average Exercise Price, Exercisable | $ 16.08 | |
17.30 - 19.07 | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Exercise price range, Lower | 17.30 | |
Exercise price range, Upper | $ 19.07 | |
Options outstanding, Number of Options | 4,406,311 | |
Options outstanding, Weighted-Average Remaining Contractual Terms | 6 years 10 months 24 days | |
Options outstanding, Weighted-Average Exercise Price | $ 17.93 | |
Number of Options, Exercisable | 3,000,465 | |
Weighted Average Exercise Price, Exercisable | $ 17.94 | |
19.19 to 36.85 | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Exercise price range, Lower | 19.19 | |
Exercise price range, Upper | $ 36.85 | |
Options outstanding, Number of Options | 3,027,063 | |
Options outstanding, Weighted-Average Remaining Contractual Terms | 3 years 4 months 24 days | |
Options outstanding, Weighted-Average Exercise Price | $ 25.98 | |
Number of Options, Exercisable | 2,891,920 | |
Weighted Average Exercise Price, Exercisable | $ 26.22 |
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, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Total intrinsic value of options exercised | $ 914 | $ 9,726 | $ 14,572 |
Total grant date fair value of options vested | $ 34,916 | $ 40,365 | $ 34,090 |
Weighted-average grant date fair value of options granted | $ 7.04 | $ 9.80 | $ 10.94 |
Stock-Based Compensation and _6
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, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 800 | $ 50,737 | $ 51,364 | $ 38,160 |
Unrecognized share-based compensation related to stock options, RSUs and ESPP, period for recognition | 2 years 8 months 12 days | |||
Restricted Stock Units | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total fair value of RSUs vested | $ 13,600 | 8,400 | 4,100 | |
Total estimated grant date fair value | $ 22,500 | $ 27,900 | $ 21,200 | |
Estimated weighted-average grant-date fair value of RSUs granted | $ 13.34 | $ 16.86 | $ 17.86 | |
Unrecognized share-based compensation related to stock options, RSUs and ESPP, period for recognition | 1 year 6 months | |||
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 _7
Stock-Based Compensation and Employee Benefits - Summary of RSUs Activity, under 2014 Plan (Details) - Restricted Stock Units - $ / shares | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Number of RSUs, beginning balances | 1,843,732 | ||
Number of RSUs granted | 1,686,875 | ||
Number of RSUs vested | (806,854) | ||
Number of RSUs canceled | (390,446) | ||
Number of RSUs, ending balance | 2,333,307 | 1,843,732 | |
Weighted-Average Grant Date Fair Value, beginning balances | $ 17 | ||
Weighted-Average Grant Date Fair Value, RSUs granted | 13.34 | $ 16.86 | $ 17.86 |
Weighted-Average Grant Date Fair Value, RSUs Vested | 16.85 | ||
Weighted-Average Grant Date Fair Value, RSUs canceled | 15.43 | ||
Weighted-Average Grant Date Fair Value, ending balances | $ 14.66 | $ 17 |
Stock-Based Compensation and _8
Stock-Based Compensation and Employee Benefits - Employee Stock Purchase Plan (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | |||
Oct. 31, 2014 | Feb. 28, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Stock-based compensation expense | $ 800 | $ 50,737 | $ 51,364 | $ 38,160 | |
Unrecognized stock-based compensation expenses related to stock options | $ 51,500 | ||||
Unrecognized share-based compensation related to stock options, RSUs and ESPP, period for recognition | 2 years 8 months 12 days | ||||
2014 Employee Stock Purchase Plan (ESPP) | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Common stock reserved for future issuance | 3,172,117 | ||||
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% | ||||
Employee stock purchase plan offering period one | --05-16 | ||||
Employee stock purchase plan offering period two | --11-16 | ||||
Unrecognized stock-based compensation expenses related to stock options | $ 700 | ||||
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% |
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, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs | ||||
Stock-based compensation expense | $ 800 | $ 50,737 | $ 51,364 | $ 38,160 |
Stock-based compensation expense capitalized into inventory | 1,187 | 1,025 | 1,460 | |
Cost of Goods Sold | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs | ||||
Stock-based compensation expense | 736 | 1,099 | 583 | |
Research and Development Expense [Member] | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs | ||||
Stock-based compensation expense | 18,999 | 18,688 | 13,837 | |
Selling, General and Administrative Expenses | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs | ||||
Stock-based compensation expense | $ 31,002 | $ 31,577 | $ 23,740 |
Stock-Based Compensation and_10
Stock-Based Compensation and Employee Benefits - Valuation Assumptions (Details) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Expected dividend yield | 0% | ||
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 | 70% | 42% | 58% |
Risk-free interest rate | 3.77% | 0.06% | 0.13% |
Employee Stock Option | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Expected term (years) | 6 years 1 month 6 days | 6 years 1 month 6 days | 6 years 1 month 6 days |
Expected volatility | 62% | 65% | 68% |
Risk-free interest rate | 2.37% | 0.89% | 1.09% |
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, 2022 | 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% | 50% | ||
First amount of each participant's contributions | $ 7,500 | $ 6,000 | ||
Compensation expense related to match plan | $ 2,100,000 | $ 1,700,000 | $ 800,000 | |
Maximum | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Percentage of maximum contribution of annual compensation | 90% | |||
Percentage of employer matching contributions | 4% |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Operating Loss Carryforwards [Line Items] | ||||
Income tax provision | $ 0 | $ 0 | $ 3,463 | |
Increase (decrease) in valuation allowance | 64,400 | 72,400 | (22,700) | |
Unrecognized tax benefits, accrued interest and penalties accrued | 0 | 0 | 0 | |
Unrecognized Tax Benefits | 16,838 | $ 15,495 | $ 13,243 | $ 11,603 |
Federal | ||||
Operating Loss Carryforwards [Line Items] | ||||
Net operating loss carryforwards | $ 591,200 | |||
Net operating loss carryforwards expiration year | 2036 | |||
Tax credit carryforwards | $ 57,700 | |||
Tax credit carryforwards expiration year | 2031 | |||
Various states | ||||
Operating Loss Carryforwards [Line Items] | ||||
Net operating loss carryforwards | $ 113,200 | |||
Net operating loss carryforwards expiration year | 2031 | |||
Tax credit carryforwards | $ 26,400 |
Income Taxes - Components of In
Income Taxes - Components of Income (Loss) Before Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Components of income (loss) before income taxes | |||
Domestic | $ (291,746) | $ (287,058) | $ 133,615 |
Foreign | (8) | (42) | 2,092 |
(Loss) income before income taxes | $ (291,754) | $ (287,100) | $ 135,707 |
Income Taxes - Provision for In
Income Taxes - Provision for Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Current | |||
State | $ 3,463 | ||
Subtotal | 3,463 | ||
Deferred | |||
Provision for income taxes | $ 0 | $ 0 | $ 3,463 |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Statutory U.S. Federal Rate (Details) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Percent of pre-tax income: | |||
United States federal statutory income tax rate | 21% | 21% | 21% |
State taxes, net of federal benefit | 1.70% | 2.60% | 2% |
Foreign rate differences | (0.30%) | ||
Permanent items | (0.10%) | 0.20% | 0.40% |
Research and development credit | 1.80% | 2.60% | (4.80%) |
Stock based compensation costs | (2.30%) | (1.20%) | 1.30% |
Other | (0.30%) | ||
Change in valuation allowance | (22.10%) | (25.20%) | (16.70%) |
Effective income tax rate | 2.60% |
Income Taxes - Components of Ne
Income Taxes - Components of Net Deferred Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Components Of Deferred Tax Assets [Abstract] | ||
Net operating loss carryforwards | $ 131,423 | $ 117,793 |
Research and development credits | 63,164 | 58,039 |
Depreciation and amortization | 51,877 | 40,620 |
Stock-based compensation | 32,561 | 30,565 |
Sales related accruals | 23,864 | 17,299 |
Other accruals | 19,717 | 11,798 |
Capitalized research and development | 17,673 | |
Gross deferred tax assets | 340,279 | 276,114 |
Right-of-use asset | (1,903) | (2,167) |
In-process research and development | (603) | (603) |
Gross deferred tax liabilities | (2,506) | (2,770) |
Total net deferred tax asset | 337,773 | 273,344 |
Less valuation allowance | $ (337,773) | $ (273,344) |
Income Taxes - Reconciliation_2
Income Taxes - Reconciliation of Unrecognized Tax Benefits (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Reconciliation Of Unrecognized Tax Benefits Excluding Amounts Pertaining To Examined Tax Returns Roll Forward | |||
Balance at beginning of year | $ 15,495 | $ 13,243 | $ 11,603 |
Additions based on tax positions related to current year | 1,385 | 2,038 | 1,749 |
Additions (reductions) for tax positions of prior years | (42) | 214 | (109) |
Balance at end of year | $ 16,838 | $ 15,495 | $ 13,243 |
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, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Numerator: | |||
Net (loss) income | $ (291,754) | $ (287,100) | $ 132,244 |
Denominator: | |||
Weighted-average common shares outstanding - Basic | 77,630,020 | 75,449,632 | 71,411,705 |
Weighted-average common shares outstanding - Diluted | 77,630,020 | 75,449,632 | 83,491,898 |
Basic net (loss) income per share | $ (3.76) | $ (3.81) | $ 1.85 |
Diluted net (loss) income per share | $ (3.76) | $ (3.81) | $ 1.62 |
Numerator: | |||
Add interest expense on 2026 Convertible Notes, net of tax | $ 3,307 | ||
Numerator for diluted net (loss) income per share | $ (291,754) | $ (287,100) | $ 135,551 |
Add effect of potential dilutive securities: | |||
Stock options, including shares subject to ESPP | 3,455,646 | ||
Restricted stock units | 167,597 | ||
Shares issuable upon conversion of convertible notes | 8,456,950 | ||
Denominator for diluted net (loss) income per share | 77,630,020 | 75,449,632 | 83,491,898 |
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, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Antidilutive securities excluded from computation of EPS | |||
Antidilutive securities excluded from the calculation of diluted net (loss) income per share | 37,635,124 | 38,122,727 | 14,002,963 |
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 | 22,214,875 | 19,895,097 | 9,521,403 |
Restricted Stock Units | |||
Antidilutive securities excluded from computation of EPS | |||
Antidilutive securities excluded from the calculation of diluted net (loss) income per share | 2,399,465 | 1,811,607 | 7,689 |
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 | 1,078,632 | 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 | 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, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Related Party Transaction | ||||
Stock-based compensation expense | $ 800 | $ 50,737 | $ 51,364 | $ 38,160 |
Consulting Agreement With Lanfear Advisors | ||||
Related Party Transaction | ||||
Number of options, granted | 65,000 | |||
Exercise price | $ 17.60 | |||
Consulting expense | $ 200 | $ 300 |
Subsequent Events (Details)
Subsequent Events (Details) € in Millions | Jan. 09, 2023 EUR (€) |
Term Sheet Agreement | Klinge Biopharma | Subsequent Event | |
Subsequent Event [Line Items] | |
Collaboration Agreement, upfront amount paid | € 30 |