Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2023 | Feb. 29, 2024 | Jun. 30, 2023 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2023 | ||
Document Transition Report | false | ||
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 | ||
Entity Small Business | false | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | true | ||
Document Financial Statement Error Correction [Flag] | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 324,137,955 | ||
Entity Common Stock, Shares Outstanding | 112,714,488 | ||
Documents Incorporated by Reference | Part III of this annual report on Form 10-K incorporates by reference certain information from the registrant’s definitive proxy statement for the 2024 Annual Meeting of Stockholders, which will be filed with the Securities and Exchange Commission within 120 days after the end of the fiscal year ended December 31, 2023. | ||
Auditor Name | Ernst & Young LLP | ||
Auditor Firm ID | 42 | ||
Auditor Location | San Mateo, California | ||
Entity Central Index Key | 0001512762 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2023 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 102,891 | $ 63,547 |
Investments in marketable securities | 14,857 | 128,134 |
Trade receivables, net | 260,522 | 109,964 |
Inventory | 62,605 | 38,791 |
Prepaid manufacturing | 23,657 | 17,880 |
Other prepaids and current assets | 11,099 | 22,918 |
Total current assets | 475,631 | 381,234 |
Property and equipment, net | 5,119 | 8,754 |
Inventory, non-current | 67,495 | 76,260 |
Intangible assets, net | 71,673 | 5,931 |
Other assets, non-current | 9,686 | 8,668 |
Total assets | 629,604 | 480,847 |
Current liabilities: | ||
Accounts payable | 35,219 | 11,526 |
Accrued rebates, fees and reserves | 169,645 | 54,461 |
Accrued compensation | 21,521 | 22,610 |
Accrued and other current liabilities | 105,386 | 50,097 |
Total current liabilities | 331,771 | 138,694 |
Term loans | 246,481 | 245,483 |
Convertible notes | 226,888 | 225,575 |
Lease liabilities, non-current | 5,328 | 5,046 |
Other liabilities, non-current | 12,561 | 3,467 |
Total liabilities | 823,029 | 618,265 |
Commitments and contingencies (Note 9) | ||
Stockholders' deficit: | ||
Common stock ($0.0001 par value; shares authorized: 300,000,000; shares issued and outstanding: 112,215,260 and 78,851,516 at December 31, 2023 and 2022, respectively) | 11 | 8 |
Additional paid-in capital | 1,386,312 | 1,204,431 |
Accumulated other comprehensive loss | (248) | (249) |
Accumulated deficit | (1,579,500) | (1,341,608) |
Total stockholders' deficit | (193,425) | (137,418) |
Total liabilities and stockholders' deficit | $ 629,604 | $ 480,847 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parentheticals) - $ / shares | Dec. 31, 2023 | Dec. 31, 2022 |
Consolidated Balance Sheets | ||
Preferred stock, par value | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 300,000,000 | 300,000,000 |
Common stock, shares issued | 112,215,260 | 78,851,516 |
Common stock, shares outstanding | 112,215,260 | 78,851,516 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Revenue: | |||
Net revenue | $ 257,244 | $ 211,042 | $ 326,551 |
Costs and expenses: | |||
Cost of goods sold | 158,992 | 70,083 | 57,591 |
Research and development | 109,436 | 199,358 | 363,105 |
Selling, general and administrative | 192,015 | 198,481 | 169,713 |
Total costs and expenses | 460,443 | 467,922 | 590,409 |
Loss from operations | (203,199) | (256,880) | (263,858) |
Interest expense | (40,542) | (32,474) | (22,959) |
Loss on debt extinguishment | (6,222) | ||
Other income (expense), net | 5,469 | 3,822 | (283) |
Loss before income taxes | (238,272) | (291,754) | (287,100) |
Income tax provision (benefit) | (380) | 0 | 0 |
Net loss | $ (237,892) | $ (291,754) | $ (287,100) |
Net loss per share: | |||
Basic (In dollar per share) | $ (2.53) | $ (3.76) | $ (3.81) |
Diluted (In dollar per share) | $ (2.53) | $ (3.76) | $ (3.81) |
Weighted-average number of shares used in computing basic and diluted net loss per share: | |||
Basic (In shares) | 94,162,637 | 77,630,020 | 75,449,632 |
Diluted (In shares) | 94,162,637 | 77,630,020 | 75,449,632 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Consolidated Statements of Comprehensive Loss | |||
Net loss | $ (237,892) | $ (291,754) | $ (287,100) |
Other comprehensive income (loss): | |||
Unrealized gain on available-for-sale securities, net of tax | 2 | 22 | |
Foreign currency translation adjustments, net of tax | (1) | (1) | |
Comprehensive loss | $ (237,891) | $ (291,733) | $ (287,100) |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity (Deficit) - USD ($) | Common Stock At The Market Offering. | Common Stock Public Offering | Common Stock Optional Stock Purchase Agreement | Common Stock | Additional Paid-In Capital At The Market Offering. | Additional Paid-In Capital Public Offering | Additional Paid-In Capital Optional Stock Purchase Agreement | Additional Paid-In Capital | Accumulated Other Comprehensive Loss | Accumulated Deficit | At The Market Offering. | Public Offering | Optional Stock Purchase Agreement | Total |
Beginning Balances at Dec. 31, 2020 | $ 7,000 | $ 1,043,991,000 | $ (270,000) | $ (762,754,000) | $ 280,974,000 | |||||||||
Beginning Balances (in shares) at Dec. 31, 2020 | 72,513,348 | |||||||||||||
Net loss | (287,100,000) | (287,100,000) | ||||||||||||
Issuance of common stock upon exercise of stock options | 10,410,000 | 10,410,000 | ||||||||||||
Issuance of common stock upon exercise of stock options (in shares) | 1,316,361 | |||||||||||||
Issuance of common stock upon vesting of restricted stock units ("RSUs") (in shares) | 465,930 | |||||||||||||
Issuance of common stock in connection with Surface Acquisition:(1) | ||||||||||||||
Stock-based compensation expense | 51,290,000 | 51,290,000 | ||||||||||||
Issuance of common stock under Offering, net of issuance costs | 40,903,000 | 40,903,000 | ||||||||||||
Issuance of common stock under Offering, net of issuance costs (in shares) | 2,491,988 | |||||||||||||
Issuance of common stock under the employee stock purchase plan ("ESPP") | 3,002,000 | 3,002,000 | ||||||||||||
Issuance of common stock under the employee stock purchase plan ("ESPP") (in shares) | 238,934 | |||||||||||||
Taxes paid related to net share settlement of RSUs | (1,753,000) | (1,753,000) | ||||||||||||
Taxes paid related to net share settlement of RSUs (in shares) | (96,465) | |||||||||||||
Ending Balances at Dec. 31, 2021 | $ 7,000 | 1,147,843,000 | (270,000) | (1,049,854,000) | 97,726,000 | |||||||||
Ending Balances (in shares) at Dec. 31, 2021 | 76,930,096 | |||||||||||||
Net loss | (291,754,000) | (291,754,000) | ||||||||||||
Issuance of common stock upon exercise of stock options | 691,000 | 691,000 | ||||||||||||
Issuance of common stock upon exercise of stock options (in shares) | 141,897 | |||||||||||||
Issuance of common stock upon vesting of restricted stock units ("RSUs") (in shares) | 806,854 | |||||||||||||
Issuance of common stock in connection with Surface Acquisition:(1) | ||||||||||||||
Stock-based compensation expense | 51,188,000 | 51,188,000 | ||||||||||||
Issuance of common stock under ATM Offering, net of issuance costs | $ 1,000 | $ 6,133,000 | $ 6,134,000 | |||||||||||
Issuance of common stock under Offering, net of issuance costs (in shares) | 916,884 | 916,884 | ||||||||||||
Issuance of common stock under the employee stock purchase plan ("ESPP") | 2,320,000 | 2,320,000 | ||||||||||||
Issuance of common stock under the employee stock purchase plan ("ESPP") (in shares) | 347,883 | |||||||||||||
Taxes paid related to net share settlement of RSUs | (3,744,000) | (3,744,000) | ||||||||||||
Taxes paid related to net share settlement of RSUs (in shares) | (292,098) | |||||||||||||
Other comprehensive gain (loss), net of tax | 21,000 | 21,000 | ||||||||||||
Ending Balances at Dec. 31, 2022 | $ 8,000 | 1,204,431,000 | (249,000) | (1,341,608,000) | $ (137,418,000) | |||||||||
Ending Balances (in shares) at Dec. 31, 2022 | 78,851,516 | 78,851,516 | ||||||||||||
Net loss | (237,892,000) | $ (237,892,000) | ||||||||||||
Issuance of common stock upon exercise of stock options | 694,000 | 694,000 | ||||||||||||
Issuance of common stock upon exercise of stock options (in shares) | 430,504 | |||||||||||||
Issuance of common stock upon vesting of restricted stock units ("RSUs") (in shares) | 1,280,901 | |||||||||||||
Issuance of common stock in connection with Surface Acquisition:(1) | ||||||||||||||
Issuance to Surface shareholders for acquisition | $ 1,000 | 58,540,000 | 58,541,000 | |||||||||||
Issuance to Surface shareholders for acquisition (in shares) | 11,971,460 | |||||||||||||
Accelerated vesting of equity awards (in shares) | 261,239 | |||||||||||||
Accelerated vesting of equity awards | 1,053,000 | 1,053,000 | ||||||||||||
Taxes paid related to net share settlement of equity awards (in shares) | (65,732) | |||||||||||||
Taxes paid related to net share settlement of equity awards | (347,000) | (347,000) | ||||||||||||
Stock-based compensation expense | 43,540,000 | 43,540,000 | ||||||||||||
Issuance of common stock under ATM Offering, net of issuance costs | $ 3,559,761 | |||||||||||||
Issuance of common stock under Offering, net of issuance costs | $ 1,000 | $ 1,000 | $ 18,316,000 | $ 53,624,000 | $ 8,179,000 | $ 18,317,000 | $ 53,625,000 | $ 8,179,000 | ||||||
Issuance of common stock under Offering, net of issuance costs (in shares) | 13,529,411 | 2,225,513 | 3,559,761 | |||||||||||
Issuance of common stock under the employee stock purchase plan ("ESPP") | 1,809,000 | 1,809,000 | ||||||||||||
Issuance of common stock under the employee stock purchase plan ("ESPP") (in shares) | 630,348 | |||||||||||||
Taxes paid related to net share settlement of RSUs | (3,527,000) | (3,527,000) | ||||||||||||
Taxes paid related to net share settlement of RSUs (in shares) | (459,661) | |||||||||||||
Other comprehensive gain (loss), net of tax | 1,000 | 1,000 | ||||||||||||
Ending Balances at Dec. 31, 2023 | $ 11,000 | $ 1,386,312,000 | $ (248,000) | $ (1,579,500,000) | $ (193,425,000) | |||||||||
Ending Balances (in shares) at Dec. 31, 2023 | 112,215,260 | 112,215,260 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Operating activities | |||
Net loss | $ (237,892) | $ (291,754) | $ (287,100) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation and amortization | 3,791 | 3,699 | 3,454 |
Stock-based compensation expense | 43,110 | 50,737 | 51,364 |
Write-off of prepaid manufacturing services related to the termination of CHS-2020 | 3,210 | ||
Inventory write-downs, net | 52,595 | 26,000 | 5,133 |
Non-cash amortization of premium (accretion of discount) on marketable securities, net | (3,052) | (730) | 1,095 |
Non-cash interest expense from amortization of debt discount and issuance costs | 2,407 | 6,431 | 4,257 |
Non-cash operating lease expense | 2,476 | 2,503 | 2,207 |
Upfront and option payments to Junshi Biosciences | 35,000 | 136,000 | |
Loss on debt extinguishment | 6,222 | ||
Other non-cash adjustments, net | (1,493) | 25 | 588 |
Changes in operating assets and liabilities: | |||
Trade receivables, net | (150,683) | 13,052 | 34,062 |
Inventory | (46,734) | (47,348) | (6,253) |
Prepaid manufacturing | 2,027 | (4,214) | 3,828 |
Other prepaid, current and non-current assets | 16,155 | (13,424) | (5,351) |
Accounts payable | 23,760 | (4,548) | 874 |
Accrued rebates, fees and reserves | 113,105 | (24,566) | (2,502) |
Accrued compensation | (5,373) | 596 | (230) |
Accrued and other current and non-current liabilities | 10,917 | 1,195 | 17,932 |
Net cash used in operating activities | (174,884) | (241,124) | (37,432) |
Investing activities | |||
Purchases of property and equipment | (286) | (2,039) | (1,289) |
Proceeds from disposal of property and equipment | 845 | ||
Purchases of investments in marketable securities | (19,507) | (127,382) | (182,485) |
Proceeds from maturities of investments in marketable securities | 144,360 | 99,692 | |
Proceeds from sale of investments in marketable securities | 13,282 | 81,672 | |
Cash and cash equivalents acquired from Surface Acquisition | 6,997 | ||
Upfront and option payments to Junshi Biosciences | (35,000) | (136,000) | |
Milestone based license fee payments | (1,051) | (2,429) | |
Net cash provided by (used in) investing activities | 144,640 | (166,850) | (138,410) |
Financing activities | |||
Proceeds from 2027 Term Loans, net of debt discount & issuance costs | 240,679 | ||
Proceeds from issuance of common stock upon exercise of stock options | 694 | 691 | 10,399 |
Proceeds from purchase under the employee stock purchase plan | 1,809 | 2,320 | 3,002 |
Taxes paid related to net share settlement | (3,587) | (3,744) | (1,753) |
Repayment of 2022 Convertible Notes and premiums | (109,000) | ||
Repayment of 2025 Term Loan, premiums and exit fees | (81,750) | ||
Other financing activities | (1,034) | (1,228) | (672) |
Net cash provided by financing activities | 69,600 | 54,326 | 51,879 |
Net increase (decrease) in cash, cash equivalents and restricted cash | 39,356 | (353,648) | (123,963) |
Cash, cash equivalents and restricted cash at beginning of period | 63,987 | 417,635 | 541,598 |
Cash, cash equivalents and restricted cash at end of period | 103,343 | 63,987 | 417,635 |
Supplemental disclosure of cash flow information | |||
Cash paid for interest | 37,857 | 34,878 | 18,684 |
Income taxes paid (refunded), net | (118) | 40 | 1,221 |
At The Market Offering. | |||
Financing activities | |||
Proceeds from issuance of common stock, net of issuance costs | 18,093 | $ 6,358 | |
Public Offering | |||
Financing activities | |||
Proceeds from issuance of common stock, net of issuance costs | $ 53,625 | ||
Junshi Biosciences | |||
Financing activities | |||
Proceeds from issuance of common stock, net of issuance costs | $ 40,903 |
Organization and Summary of Sig
Organization and Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2023 | |
Organization and Summary of Significant Accounting Policies | |
Organization and Summary of Significant Accounting Policies | Coherus BioSciences, Inc. Notes to Consolidated Financial Statements 1. Description of the Business Coherus BioSciences, Inc. (the “Company” or “Coherus”) is a commercial-stage biopharmaceutical company focused on the research, development and commercialization of its portfolio of FDA-approved oncology products, including LOQTORZI. The Company’s strategy is to build a leading immuno-oncology business funded with cash generated from 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) (ranibizumab-eqrn) (adalimumab-aqvh), a biosimilar to Humira (adalimumab), The Company’s product pipeline comprises the following three product candidates: CHS-1000, an antibody targeting ILT4; casdozokitug (CHS-388, formerly SRF388), an antibody targeting IL-27; and CHS-114 (formerly SRF114), a highly specific afucosylated IgG1 antibody targeting CCR8. In addition to the Company’s internally developed portfolio of product candidates, the Company has two product candidates, NZV930 and GSK4381562, which are exclusively licensed to Novartis Institutes and GSK, respectively. 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 interest 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. 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: 2023 2022 2021 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 December 31, At end of period: 2023 2022 2021 Cash and cash equivalents $ 102,891 $ 63,547 $ 417,195 Restricted cash 452 440 440 Total cash, cash equivalents and restricted cash $ 103,343 $ 63,987 $ 417,635 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 used in investing activities in its consolidated statements of cash flows. 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, 2023 and 2022. Investments in Marketable Securities Investments in marketable securities primarily consist of U.S. Treasury securities, government agency securities, commercial paper, corporate bonds and market money funds. 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 2023, 2022 and 2021, interest income from marketable securities was $2.8 million, $1.9 million and $1.4 million, respectively, and is included in other income (expense), net, in the consolidated statements of operations. 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. During 2023, the products sold by the Company were UDENYCA, CIMERLI, YUSIMRY and LOQTORZI. During 2022, UDENYCA and CIMERLI were the only products sold by the Company, and in 2021 UDENYCA accounted for all of the Company’s revenues. 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. Derivative Instruments In January 2023, the Company commenced using derivative contracts (foreign exchange option contracts) for the purpose of economically hedging exposure to changes in currency fluctuations between the U.S. Dollar and the Euro. The Company recognizes all derivatives at fair value on the consolidated balance sheets, and corresponding gains and losses are recognized in other income (expense), net in the consolidated statements of operations. The estimated fair value of derivative financial instruments represents the amount required to enter into similar contracts with similar remaining maturities based on quoted market prices. During the periods presented, the Company did not apply hedge accounting to these instruments. There are no derivative instruments entered into for speculative or trading purposes. Since the Company's foreign exchange derivatives all matured and settled by December 31, 2023, there were no derivative assets or derivative liabilities Business Combination Accounting & Valuation of Acquired Assets The Company accounts for acquisitions of entities that include inputs and processes and have the ability to create outputs as business combinations. Judgment is required in assessing whether the acquired processes or activities, along with their inputs, meet the criteria to constitute a business, as defined by U.S. GAAP. The acquisition method of accounting requires the recognition of assets acquired and liabilities assumed at their acquisition date fair values. The excess of the fair value of consideration transferred over the fair value of the net assets acquired is recorded as goodwill, or when there is an excess of the fair values of these identifiable assets and liabilities over the fair value of purchase consideration, a bargain purchase gain is recorded in the consolidated statements of operations. The estimations of fair values based on non-observable inputs that are included in valuation models. An income approach, which generally relies upon projected cash flow models, is used in estimating the fair value of the acquired intangible assets. These cash flow projections are based on management's estimates of economic and market conditions including the estimated future cash flows from revenues of acquired assets, the timing and projection of costs and expenses and the related profit margins, tax rates, and discount rate. During the measurement period, which occurs before finalization of the purchase price allocation, changes in assumptions and estimates that result in adjustments to the fair values of assets acquired and liabilities assumed, if based on facts and circumstances existing at the acquisition date, are recorded on a retroactive basis as of the acquisition date, with the corresponding offset to goodwill or bargain purchase gain (See Note 6. Surface Acquisition). Foreign Currency Monetary assets and liabilities denominated in foreign currency are remeasured at period-end exchange rates. 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 experienced material foreign currency transaction gains and losses for any of the 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 2023 and 2022, the Company recorded $52.6 million and $26.0 million in inventory write-downs, respectively, within cost of goods sold in the consolidated statements of operations. The 2023 charge was primarily for the write-down of slow moving YUSIMRY inventory and the related partial recognition of certain firm purchase commitments. The 2022 charge was due to the competitive environment and lower demand for UDENYCA resulting in certain inventory becoming at risk of expiration. 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 statements 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 incurs expenses for the manufacture of drug products 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, 2023 was related to UDENYCA, YUSIMRY, CIMERLI and LOQTORZI. 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. 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 commence amortization over the useful life of the intangible asset, which will generally be determined by the period in which the substantial majority of the cash flows are expected to be generated. Finite-lived intangible assets are generally amortized on a straight-line basis over their estimated economic life and are reviewed periodically for impairment. The amortization expense related to capitalized milestone payments under license agreements and the amortization expense from out-licenses are recorded as a component of cost of goods sold in the consolidated statements of operations. The estimated life for capitalized milestone payments is ten years, and the life for acquired out-licenses is fifteen years. 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. 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. Contingent Consideration Contingent consideration relates to the potential payments to holders of the CVRs that are contingent upon the achievement of the Company and certain third-parties meeting product development or financial performance milestones. For transactions accounted for as business combinations, the Company records contingent consideration at fair value at the date of the acquisition based on the consideration expected to be transferred. Liabilities for contingent consideration are remeasured each reporting period and subsequent changes in fair value are recognized within loss from operations in the consolidated statements of operations. The assumptions utilized in the calculation of the fair values include probability of success and the discount rates. Contingent consideration involves certain assumptions requiring significant judgment and actual results may differ from estimated amounts. 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 and non-current liabilities (if the amounts are payable to a party other than a Customer). Where appropriate, these estimates take into consideration a range of possible outcomes that are probability-weighted for relevant factors such as historical experience, current contractual and statutory requirements, specifically known market events and trends, industry data and forecasted Customer buying and payment patterns. Overall, these reserves reflect the best estimates of the amount of consideration to which the Company is entitled based on the terms of its contracts. The amount of variable consideration that is included in the transaction price may be constrained, and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. The actual amount of consideration ultimately received may differ. If actual results in the future vary from the Company’s estimates, the estimates will be adjusted, which will affect net product revenue in the period that such variances become known. Chargebacks: Discounts for Prompt Payment: Rebates: Co-payment Assistance: Product Returns: Other Allowances: Royalty Revenue Royalty revenue from licensees, which is based on sales to third parties of licensed products, is recorded when the third-party sale occurs and the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). Royalty revenue was immaterial 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, certain overhead costs, royalties on certain products, and charges for inventory write-downs. 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 UDENYCA 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. The Company incurs royalties on net sales of LOQTORZI in the low- to mid-twenty percent range and on net sales of YUSIMRY in the mid-single digit range. Pursuant to the Genentech Agreement, the Company incurred a royalty that was a low single-digit percentage of net sales of CIMERLI through the end of 2023. In 2023, 2022 and 2021, cost of goods sold included inventory write-downs, net of $52.6 million, $26.0 million and $5.1 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 $10.9 million, $10.5 million and $8.7 million in 2023, 2022 and 2021, 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. The Company accounts for stock issued in connection with business combinations based on the fair value of the Company’s common stock on the date of issuance. 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 2024. 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 or the lease modification date, as applicable, in determining the lease liabilities as the Company's leases generally do not provide an implicit rate. Net Loss Per Share Basic net loss per share is calculated by dividing the net loss by the weighted-average number of shares of common stock outstanding for the period, without consideration for potential dilutive common shares. 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 Comprehensive loss includes the following two components: net loss and other comprehensive income (loss). Other comprehensive income (loss) refers to gains and losses that are recorded as an element of stockholders’ equity (deficit), but are excluded from net loss. The Company’s other comprehensive inco |
Revenue
Revenue | 12 Months Ended |
Dec. 31, 2023 | |
Revenue | |
Revenue | 2. The Company launched LOQTORZI and YUSIMRY in the United States in December and July 2023, respectively, and initiated sales of CIMERLI on October 3, 2022. All net product revenue was generated in the United States, and the Company’s net revenue was as follows: Year Ended December 31, (in thousands) 2023 2022 2021 Products UDENYCA $ 127,064 $ 203,814 $ 326,509 CIMERLI 125,388 6,946 — YUSIMRY 3,574 — — LOQTORZI 554 — — Total net product revenue 256,580 210,760 326,509 Other 664 282 42 Total net revenue $ 257,244 $ 211,042 $ 326,551 Gross product revenues by significant customer as a percentage of total gross product revenues were as follows Year Ended December 31, 2023 2022 2021 McKesson Corporation 40 % 38 % 39 % Cencora (previously known as AmeriSource-Bergen Corporation) 43 % 44 % 39 % Cardinal Health, Inc. 15 % 17 % 20 % Product Sales Discounts and Allowances Provisions that reduce net revenue include chargebacks and discounts for prompt payment, which are recorded as a reduction in trade receivables, and rebates, other fees, co-pay assistance and returns, which are recorded as current liabilities and other liabilities, non-current in the accompanying consolidated balance sheets. The activities and ending reserve balances for each significant category of sales discounts and allowances, which constitute variable consideration, are as follows: 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 - increase (decrease) (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 Provision related to sales made in: Current period 436,865 68,399 73,435 578,699 Prior period - increase (decrease) (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 Provision related to sales made in: Current period 590,772 143,370 110,183 844,325 Prior period - increase (decrease) (1,361) 1,424 3,744 3,807 Payments and customer credits issued (558,135) (62,370) (83,245) (703,750) Balances at December 31, 2023 $ 73,953 $ 121,137 $ 49,795 $ 244,885 |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2023 | |
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. The fair values of cash equivalents approximate their carrying values due to the short-term nature of such financial instruments. In connection with the Surface Acquisition on September 8, 2023 (see Note 6. Surface Acquisition), the Company acquired money market funds and marketable securities and recorded a contingent consideration liability related to the CVRs. At the end of each reporting period, the fair value of the CVR liability is determined using a financial model representing a Level 3 measurement within the fair value hierarchy. Assumptions used in this calculation include estimated revenue, discount rate and various probability factors. If different assumptions were used for the various inputs, the estimated fair value could be significantly higher or lower than the fair value the Company determined. For example, increases in discount rates and the time to payment may result in lower fair value measurements. There is no assurance that any of the conditions for payment of the CVR liability will be met. As of December 31, 2023, the CVR liability was reduced by a fair value adjustment of $0.9 million which was recorded within selling, general and administrative expense in the consolidated statements of operations. The CVR liabilities were recorded in accrued and other current liabilities and other liabilities, non-current on the consolidated balance sheets. Financial liabilities related to long-term debt obligations are summarized in Note 8. Debt Obligations. Other financial liabilities and financial assets measured at fair value on a recurring basis are summarized as follows: Fair Value Measurements December 31, 2023 (in thousands) Level 1 Level 2 Level 3 Total Financial Assets: Cash equivalents (1) $ 88,460 $ 998 $ — $ 89,458 Marketable debt securities: U.S. government agency securities 5,195 — — 5,195 U.S. treasury securities 2,993 — — 2,993 Commercial paper and corporate notes — 6,669 — 6,669 Prepaid financial instrument in Prepaid manufacturing (2) — — 625 625 Total $ 96,648 $ 7,667 $ 625 $ 104,940 Financial Liabilities: Contingent consideration $ — $ — $ 4,472 $ 4,472 Fair Value Measurements December 31, 2022 (in thousands) Level 1 Level 2 Level 3 Total Financial Assets: Cash equivalents (1) $ 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 (1) Cash equivalents consist of money market funds, U.S treasury securities, and commercial paper and corporate notes with original maturities of 90 days or less. (2) Relates to Optional Stock Purchase Agreement. The cost, unrealized gains or losses, and fair value by investment type are summarized as follows: December 31, 2023 (in thousands) Cost Unrealized Gain Unrealized (Loss) Fair Value Money market funds $ 79,484 $ — $ — $ 79,484 U.S. government agency securities 5,200 — (5) 5,195 U.S. treasury securities 11,967 2 — 11,969 Commercial paper and corporate notes 7,673 — (6) 7,667 Total $ 104,324 $ 2 $ (11) $ 104,315 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 9 and 13 positions that were in unrealized loss positions as of December 31, 2023 and 2022, respectively. No impairment was recognized in 2023 or 2022. As of December 31, 2023 and 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 9 and 7 months , respectively. The accrued interest receivable on available-for-sale marketable securities was immaterial at December 31, 2023 and 2022. |
Inventory
Inventory | 12 Months Ended |
Dec. 31, 2023 | |
Inventory | |
Inventory | 4. Inventory consisted of the following: December 31, (in thousands) 2023 2022 Raw materials $ 12,975 $ 10,262 Work in process 82,588 86,712 Finished goods 34,537 18,077 Total $ 130,100 $ 115,051 During 2023, the Company recorded a $47.0 million charge for the write-down of slow moving YUSIMRY inventory, inclusive of the related partial recognition of $20.5 million in certain firm purchase commitments in cost of goods sold in the consolidated statements of operations. The Company has presented the partial recognition of these certain firm purchase commitments in the amounts of $11.5 million and $9.0 million in accrued and other current liabilities and other liabilities, non-current, respectively, in the consolidated balance sheets as of December 31, 2023. 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, 2023 and 2022, 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) 2023 2022 Inventory $ 62,605 $ 38,791 Inventory, non-current 67,495 76,260 Total $ 130,100 $ 115,051 Prepaid manufacturing of $23.7 million as of December 31, 2023 includes prepayments of $12.6 million to CMOs for manufacturing services of the Company’s products, which the Company expects to be converted into inventory during 2024, and prepayments of $11.1 million to various CMOs for research and development pipeline programs . as of December 31, 2022 included prepayments of $13.0 million to CMOs for manufacturing services of the Company’s products and prepayments of $4.9 million to various CMOs for 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 statements 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, 2023 | |
Balance Sheet Components | |
Balance Sheet Components | 5. Property and Equipment, Net Property and equipment, net consisted of the following: December 31, (in thousands) 2023 2022 Machinery and equipment $ 13,124 $ 12,944 Computer equipment and software 3,546 3,183 Furniture and fixtures 1,055 1,258 Leasehold improvements 5,751 6,198 Finance lease right of use assets 2,294 4,632 Construction in progress — 696 Total property and equipment 25,770 28,911 Accumulated depreciation and amortization (20,651) (20,157) Property and equipment, net $ 5,119 $ 8,754 Depreciation and amortization expense related to property and equipment, net was $3.2 million, $3.6 million and $3.5 million in 2023, 2022 and 2021, respectively. There were no material impairments of property and equipment in 2023, 2022 and 2021. As of December 31, 2023 and 2022, the net book value of software implementation costs related to hosting arrangements was $3.2 million and $3.5 million, respectively, and the amortization expense was immaterial for all periods presented. Intangible Assets, Net Goodwill and intangible assets, net consisted of the following: December 31, (in thousands) 2023 2022 Finite-lived assets, net of accumulated amortization of $639 and $61, respectively $ 41,871 $ 2,368 Indefinite-lived assets - IPR&D 28,859 2,620 Goodwill 943 943 Total Intangible assets, net $ 71,673 $ 5,931 Amortization expense related to finite-lived intangible assets was immaterial in all periods presented. As of December 31, 2023, amortization expense related to finite-lived assets for each of the five succeeding fiscal years will be approximately $3.8 million. The weighted average remaining life of the finite-lived assets is 11.4 years on December 31, 2023. No impairment charges were recognized for goodwill or intangible assets during 2023, 2022 or 2021. During 2023, the Company’s intangible assets increased due to assets acquired in the Surface Acquisition (see Note 6. Surface Acquisition) and capitalized milestone payments, including $25.0 million to Junshi Biosciences (see Note 7. Collaborations and Other Arrangements). Accrued and Other Current Liabilities Accrued and other current liabilities consisted of the following: December 31, December 31, (in thousands) 2023 2022 Accrued commercial and research and development manufacturing $ 23,470 $ 21,774 Accrued co-development costs and milestone payments 26,812 8,356 Accrued royalties 42,031 5,015 Accrued other 7,628 10,634 Lease liabilities, current 2,145 4,318 Contingent consideration, current 3,300 — Total Accrued and other current liabilities $ 105,386 $ 50,097 Other Liabilities, Non-current Other liabilities, non-current consisted of the following: December 31, December 31, (in thousands) 2023 2022 Contingent consideration, non-current $ 1,172 $ 102 Deferred tax liability 1,102 — Other 10,287 3,365 Total Other liabilities, non-current $ 12,561 $ 3,467 |
Surface Acquisition
Surface Acquisition | 12 Months Ended |
Dec. 31, 2023 | |
Surface Acquisition | |
Surface Acquisition | 6. Surface Acquisition On September 8, 2023, in accordance with Merger Agreement by the Merger Subs, and Surface, the Company completed the Surface Acquisition. Surface is a clinical-stage immuno-oncology company focused on using its specialized knowledge of the biological pathways critical to the immunosuppressive tumor microenvironment for the development of next-generation cancer therapies. The Surface Acquisition expanded the Company’s immune-oncology pipeline with the following: casdozokitug (CHS-388, formerly SRF388), an investigational, novel IL-27-targeted antibody currently being evaluated in a Phase 2 clinical trial in HCC, and CHS-114 (formerly SRF114), an investigational, CCR8-targeted antibody currently in a Phase 1/2 study as a monotherapy in patients with advanced solid tumors. On the Acquisition Date, and in accordance with the Merger Agreement, the Company issued to the holders of all outstanding Surface common stock (other than treasury shares, any shares of Surface common stock held directly by the Company or the Merger Subs immediately prior to the Acquisition Date and shares of Surface common stock issued and outstanding immediately prior to the Acquisition Date and held by any holder properly demanding appraisal for such shares in accordance with Section 262 of the Delaware General Corporation Law) 0.1960 shares of Coherus common stock in exchange for each share of outstanding Surface common stock and certain outstanding Surface employee equity awards. The exchange ratio was calculated pursuant to the terms of the Merger Agreement and was based on a $5.2831 per share price of Coherus common stock and a nominal total amount of cash in lieu of fractional shares. Surface shareholders also received one CVR for each share of Surface common stock and employee equity award converted. Each CVR entitles the holder to receive quarterly contingent payments in the form of cash, stock or a combination of cash and stock at the Company’s discretion during the ten-year period following September 8, 2023, for the sum of the following, less any permitted deductions in accordance with the CVR Agreement: ● 70% of all milestone- and royalty-based payments actually received by the Company or its affiliates under the GSK Agreement related to the existing program (GSK4381562); ● 70% of all milestone- and royalty-based payments actually received by the Company or its affiliates under the Novartis Agreement related to the existing program (NZV930); ● 25% of any upfront payment actually received by the Company or its affiliates pursuant to potential ex-U.S. licensing agreements for CHS-114; and ● 50% of any upfront payment actually received by the Company or its affiliates pursuant to potential ex-U.S. licensing agreements for casdozokitug. The Company has recorded a contingent consideration liability for the fair value of the potential payments under the CVR Agreement described above. The Company is unable to estimate a range of outcomes for potential royalty and milestone payments for CHS-114 and casdozokitug. The total consideration paid for the Surface Acquisition of $64.6 million consisted of the following: (in thousands, except share and per share amounts) As of Acquisition Date Coherus common stock issued 11,971,460 Coherus common stock share price $ 4.89 Fair value of components of purchase price consideration at closing: Equity of combined company owned by Surface equity holders $ 58,540 Contingent CVR liability 5,290 Equity of combined company owned by Surface former employees (1) 766 Fair value of total purchase consideration $ 64,596 (1) Represents 161,100 shares of Coherus common stock, net of shares withheld for taxes, issued to Surface’s former employees on the Acquisition Date. The Company has accounted for the Surface Acquisition as a business combination which requires, among other things, that the assets acquired and liabilities assumed generally be recognized at their fair value on the Acquisition Date. Fair value estimates are based on management’s estimated future cash flows from revenues of acquired assets, the timing and projection of costs and expenses and the related profit margins, tax rates, and discount rate. The judgments used to determine the estimated fair value assigned to each class of assets acquired and liabilities assumed, as well as asset lives, can materially impact the Company’s results of operations. The purchase price allocation for the Surface Acquisition is preliminary and subject to revisions as additional information about fair value of assets and liabilities becomes available. This is primarily related to the Company’s deferred tax liabilities assumed in connection with the Surface Acquisition, as the 2023 short period tax returns have not yet been filed. The following table below sets forth the purchase price allocation to the estimated fair value of the net assets acquired: (in thousands) Amounts Recognized at Acquisition Date Assets Acquired Cash and cash equivalents $ 6,997 Investments in marketable securities 21,791 Other prepaids and other assets 5,260 In-process research and development 26,239 Out-licenses 13,530 Total assets $ 73,817 Liabilities Assumed Accrued and other current liabilities $ 7,722 Deferred tax liability 1,499 Total liabilities 9,221 Total net assets acquired $ 64,596 The Company believes that, even after reassessing its identification of all assets acquired and liabilities assumed, it was able to acquire Surface for a price that was completely allocable to identifiable assets acquired and liabilities assumed with no residual attributable to goodwill primarily due to Surface’s need to raise additional capital to finance its operations, the challenging biotech funding environment at the time the transaction was initially announced, and the value of the acquired net assets. The amount allocated to identifiable intangible assets has been attributed to the following assets: (in thousands) Useful lives Fair Value at Acquisition Date In-process research and development - casdozokitug n/a $ 25,899 In-process research and development - CHS-114 n/a 340 Out-license - GSK 15 years 2,506 Out-license - Novartis Institutes 15 years 11,024 Total identifiable intangible assets $ 39,769 Surface had two out-licensed partnership programs, with Novartis Institutes (NZV930) and GSK (GSK4381562), to advance certain next-generation cancer therapies. The out-license intangible assets represent potential milestone and royalty-based payments to be received in the future. Surface shareholders received CVRs for certain percentages of these milestone and royalty-based payments on existing programs with Novartis Institutes (NZV930) and GSK (GSK4381562), as further explained above. Following the Acquisition Date, the operating results of Surface have been included in the consolidated financial statements. For the period September 8, 2023 through December 31, 2023, there was no revenue attributable to Surface and operating losses attributable to Surface for such period were $5.9 million, excluding acquisition-related costs. Unaudited Pro Forma Summary of Operations The following table shows the unaudited pro forma summary of operations for the years ended December 31, 2023 and 2022, as if the Surface Acquisition had occurred on January 1, 2022. This pro forma information does not purport to represent what the Company’s actual results would have been if the acquisition had occurred as of January 1, 2022, and it is not indicative of what such results would be expected for any future period: Year Ended December 31, (in thousands) 2023 2022 Total revenues $ 257,244 $ 241,042 Net loss $ (284,575) $ (369,442) The unaudited pro forma financial information was prepared using the acquisition method of accounting and was based on the historical financial information of the Company and Surface. In order to reflect the Surface Acquisition as if it had occurred on January 1, 2022, the summary pro forma financial information includes adjustments to reflect Surface’s severance expense, the early termination and related amortization expense of Surface’s corporate headquarters operating lease, the loss on debt extinguishment and historical interest expense related to the cash settlement of Surface’s convertible note as if it had occurred on January 1, 2022, and amortization expense on the acquired finite-lived intangible assets. The unaudited pro forma summary of operations does not reflect the income tax effects, if any, of the pro forma adjustments, given the combined entity incurred significant losses during the historical periods presented. Acquisition-related costs of $5.1 million were recorded in selling, general and administrative expense in the consolidated statements of operations during the year ended December 31, 2023. |
Collaborations and Other Arrang
Collaborations and Other Arrangements | 12 Months Ended |
Dec. 31, 2023 | |
Collaborations and Other Arrangements | |
Collaborations and Other Arrangements | 7. Collaborations and Other Arrangements In-Licensing Agreements Junshi Biosciences On February 1, 2021, the Company entered into the Collaboration Agreement with Junshi Biosciences for the co-development and commercialization of LOQTORZI, 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 LOQTORZI 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 LOQTORZI in the United States and Canada. The Company will be obligated to pay Junshi Biosciences up to a 20% royalty on net sales of LOQTORZI 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 were jointly developing CHS-006 with each party responsible for the associated development costs as set forth in the Collaboration Agreement, however on January 10, 2024, the Company announced that it had delivered a notice of termination of the TIGIT Program (as defined in the Collaboration Agreement) to Junshi Biosciences pursuant to the Collaboration Agreement. The Company plans to continue to wind down work with Junshi Biosciences on the TIGIT Program pursuant to the termination. If the Company exercises its remaining option for the IL-2 cytokine, it will be obligated to pay Junshi Biosciences an additional option exercise fee of $35.0 million and 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 LOQTORZI and the other licensed compounds and will pay for a portion of these co-development activities up to a maximum of $25.0 million per licensed compound per year. Additionally, the Company is responsible for certain associated regulatory and technology transfer costs for LOQTORZI 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 $8.0 million, $68.5 million (inclusive of the $35.0 million option fee) and $175.4 million (inclusive of the upfront fee) in 2023, 2022, and 2021 respectively. In the consolidated balance sheets as of December 31, 2023 and 2022, the Company classified $26.3 million and $8.4 million, respectively, in accrued and other current liabilities and $6.3 million and $0 in accounts payable, respectively, related to the co-development, regulatory and technology transfer costs related to these programs. On October 27, 2023, LOQTORZI was approved by the FDA in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced NPC, and as monotherapy for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy. . The accrued royalty obligation to Junshi Biosciences is immaterial as of December 31, 2023. In connection with the Collaboration Agreement, the Company entered into a stock purchase agreement dated February 1, 2021 (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 was 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 (“DLOM”) 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 statements of operations for the year ended December 31, 2021. 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 was required to 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 was required to use commercially reasonable efforts to commercialize the Bioeq Licensed Products in accordance with a commercialization plan. Additionally, the Company was required to 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 statements 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. 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 $38.4 million and $2.9 million as of December 31, 2023 and 2022, respectively. The remaining milestone payments are contingent upon future events and, therefore, will be recorded when it becomes probable that a milestone will be achieved. Adimab Development and Option Agreement In October 2018, Surface and Adimab entered into the A&R Adimab Agreement, which amended and restated the Original Adimab Agreement, for the discovery and optimization of proprietary antibodies as potential therapeutic product candidates. Under the A&R Adimab Agreement, the Company will select biological targets against which Adimab will use its proprietary platform technology to research and develop antibody proteins using a mutually agreed upon research plan. The A&R Adimab Agreement, among other things, extended the discovery term of the Original Adimab Agreement, provided access to additional antibodies, and expanded the Company’s right to evaluate and use antibodies that were modified or derived using Adimab technology for diagnostic purposes. Upon the Company’s selection of a target, the Company and Adimab will initiate a research plan and the discovery term begins. During the discovery term, Adimab will grant the Company a non-exclusive, non-sublicensable license under its technology with respect to the target, to research, design and preclinically develop and use antibodies that were modified or derived using Adimab technology, solely to evaluate such antibodies, perform the Company’s responsibilities under the research plan, and use such antibodies for certain diagnostic purposes. The Company also will grant to Adimab a non-exclusive, nontransferable license with respect to the target under the Company’s technology that covers or relates to such target, solely to perform its responsibilities under the research plan during the discovery period. The Company is required to pay Adimab at an agreed upon rate for its full-time employees during the discovery period while Adimab performs research on each target under the applicable research plan. Adimab granted the Company the Research Option. In addition, Adimab granted the Company the Commercialization Option. Upon the exercise of a Commercialization Option, and payment of the applicable option fee to Adimab, Adimab will assign the Company the patents that cover the antibodies selected by such Commercialization Option. The Company will be required to use commercially reasonable efforts to develop, seek market approval of, and commercialize at least one antibody against the target covered by the Commercialization Option in specified markets upon the exercise of a Commercialization Option. Under the A&R Adimab Agreement, the Company is obligated to make milestone payments and to pay specified fees upon the exercise of the Research Option or Commercialization Option. During the discovery term, the Company may be obligated to pay Adimab up to $0.3 million for technical milestones achieved against each biological target. Upon exercise of a Research Option, the Company is obligated to pay a nominal research maintenance fee on each of the next four single-digit royalties on net sales. No additional payment is due with respect to any companion diagnostic or any diagnostic product that does not contain any licensed antibody. Any payments payable to Adimab as a result of any product candidates being developed pursuant to the GSK Agreement, will be payable to Adimab directly by GSK. The A&R Adimab Agreement will remain in effect until (a) the earlier of (i) the expiration of the Research and Commercialization Options (if they expire without exercise) and (ii) 12 months from the effective date without the Company providing materials that pass Adimab’s quality control; or (b) if a Research Option is exercised but the Commercialization Option is not, then upon the expiration of the last to expire research license term; or (c) upon commercialization of a product, until the end of the royalty term, which will vary on a product-by-product and country-by-country basis, ending on the later of (y) the expiration of the last valid claim covering the licensed product in such country as the product is manufactured or sold, or (z) ten years after the first commercial sale of the licensed product in such country. Either party may terminate the A&R Adimab Agreement for material breach if such breach remains uncured for a specified period of time, however, if a Research Option or Commercialization Option has been exercised and the breach only applies to the applicable target of such Research Option or Commercialization Option, then the termination right will only apply to such target. The Company may also terminate the A&R Adimab Agreement for any reason with prior notice to Adimab. If Adimab is bankrupt, the Company will be entitled to a complete duplicate of, or complete access to, all rights and licenses granted under or pursuant to the A&R Adimab Agreement. Vaccinex License Agreement On March 23, 2021, Surface and Vaccinex entered into the Vaccinex License Agreement which provides the Company a worldwide, exclusive, sublicensable license to make, have made, use, sell, offer to sell, have sold, import, and otherwise exploit Vaccinex Licensed Products, including the antibody CHS-114 targeting CCR8. Under the Vaccinex License Agreement, the Company is obligated to use commercially reasonable efforts to develop, clinically test, achieve regulatory approval, manufacture, market and commercialize at least one Vaccinex Licensed Product. The Company is responsible for all costs and expenses of such development, manufacturing and commercialization. Vaccinex is eligible to receive up to an aggregate of $3.5 million based on achievement of certain clinical milestones, up to an aggregate of $11.5 million based on achievement of certain regulatory milestones per Vaccinex Licensed Product, and low single-digit royalties on global net sales of any approved licensed products. The Company may terminate the Vaccinex License Agreement for convenience upon the notice period specified in the Vaccinex License Agreement. Either party may terminate the agreement for an uncured material breach by the other party. Vaccinex may terminate the Vaccinex License Agreement if we default on any payments owed to Vaccinex under the agreement, if the Company is in material breach of, and fails to cure, its development obligations, or institute certain actions related to the licensed patents. In the event of termination, all rights in the licensed intellectual property would revert to Vaccinex. Out-Licensing Agreements Acquired as part of the Surface Acquisition On September 8, 2023, at the closing of the Surface Acquisition, all the assets, liabilities, rights and obligations of Surface were assumed by the Company’s direct, wholly-owned subsidiary, Surface Oncology, LLC. See further details in Note 6. Surface Acquisition above. Novartis Institutes In January 2016, Surface entered into the Novartis Agreement. Pursuant to the Novartis Agreement, Surface granted Novartis Institutes a worldwide exclusive license to research, develop, manufacture and commercialize antibodies that target cluster of differentiation 73 (“CD73”). Under the Novartis Agreement, the Company is currently entitled to potential development milestones of $325.0 million and sales milestones of $200.0 million, as well as tiered royalties on annual net sales by Novartis Institutes ranging from high single-digit to mid-teens percentages upon the successful commercialization of NZV930. Due to the uncertainty of pharmaceutical development and the historical failure rates generally associated with drug development, the Company may not receive any milestone payments or any royalty payments under the Novartis Agreement. The Company did not recognize any revenue relating to the Novartis Agreement from September 8, 2023 through December 31, 2023. Unless terminated earlier, the Novartis Agreement will continue in effect until neither the Company nor Novartis Institutes is researching, developing, manufacturing or commercializing NZV930. Novartis Institutes may terminate the Novartis Agreement for any or no reason upon prior notice to the Company within a specified time period. Either party may terminate the Novartis Agreement in full if an undisputed material breach is not cured within a certain period of time or upon notice of insolvency of the other party. To the extent Novartis Institutes terminates for convenience, or the Company terminates for Novartis Institutes’ uncured material breach, Novartis Institutes will grant the Company, on mutually agreeable financial terms, an exclusive, worldwide, irrevocable, perpetual and royalty-bearing license with respect to intellectual property controlled by Novartis Institutes that is reasonably necessary to research, develop, manufacture or commercialize NZV930. GSK Agreement In December 2020, Surface entered into the GSK Agreement. Pursuant to the GSK Agreement, Surface granted GSK a worldwide exclusive, sublicensable license to develop, manufacture and commercialize the Licensed Antibodies. GSK is responsible for the development, manufacturing and commercialization of the Licensed Antibodies and a joint development committee was formed to facilitate information sharing. GSK is responsible for all costs and expenses of such development, manufacturing and commercialization and is obligated to provide the Company with updates on its development, manufacturing and commercialization activities through the joint development committee. Unless terminated earlier, the GSK Agreement expires on a licensed product-by-licensed product and country-by-country basis on the later of ten years from the date of first commercial sale or when there is no longer a valid patent claim or regulatory exclusivity covering such licensed product in such country. Either party may terminate the GSK Agreement for an uncured material breach by the other party or upon the bankruptcy or insolvency of the other party. GSK may terminate the GSK Agreement for its convenience. The Company may terminate the GSK Agreement if GSK institutes certain actions related to the licensed patents or if GSK ceases development activities, other than for certain specified technical or safety reasons. In the event of termination, the Company would regain worldwide rights to the terminated program. |
Debt Obligations
Debt Obligations | 12 Months Ended |
Dec. 31, 2023 | |
Debt Obligations | |
Debt Obligations | 8. A summary of the Company’s debt obligations, including level within the fair value hierarchy (see Note 3. Fair Value Measurements), is as follows: At December 31, 2023 (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 $ (3,519) $ 246,481 $ 246,481 Level 2* 2026 Convertible Notes $ 230,000 $ (3,112) $ 226,888 $ 150,155 Level 2** 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** * The principal amounts outstanding are subject to variable interest rates, which are based on three-month SOFR starting April 1, 2023 plus fixed percentages. Through March 31, 2023, the variable component was based on the three-month LIBOR. Therefore, the Company believes the carrying amount of these obligations approximates fair value. ** 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 accrued 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 2023 was 13.91%. 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 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 began at $200.0 million for the quarter ending March 31, 2022 and increases to $210.0 million for the quarter ended March 31, 2024. As a result of the Consent and Amendment entered into on February 5, 2024, beginning in the second quarter of 2024 and continuing through the quarter ended December 31, 2026, the requirement is to maintain minimum trailing twelve-month net sales of $125.0 million. In addition, there is a requirement to maintain a minimum trailing twelve-month net sales for LOQTORZI tested quarterly at the end of each quarter commencing with the quarter ended December 31, 2024. Further, the Loan Agreement includes certain other affirmative covenants and negative covenants, including, covenants and restrictions that among other things, restrict 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. See Note 17. Subsequent Events for further information regarding the Consent and Amendment to the 2027 Term Loans. As of December 31, 2023, 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 discount and issuance costs allocated to funded tranches are presented as deductions to the 2027 Term Loan balance and are amortized into interest expense using the effective interest method. The $2.3 million allocated to Tranche B was fully amortized over the commitment period prior to funding and recognized as interest expense in the first quarter of 2022. The associated debt discounts and issuance costs of unfunded tranches were deferred as assets and amortized into interest expense using the straight-line method over the commitment period of the respective tranches. At the closing dates of Tranche B on March 31, 2022 and Tranche D on September 14, 2022, the Company incurred an additional $1.0 million and $0.5 million, respectively, in debt issuance costs. As of December 31, 2023, the total remaining unamortized debt discount and debt offering costs related to Tranches A, B and D of $3.5 million will be amortized using the effective interest rate over the remaining term of 3.0 years. The following table presents the components of interest expense related to the 2027 Term Loans: Year Ended December 31, (in thousands) 2023 2022 Contractual interest $ 34,289 $ 20,243 Amortization of debt discount and debt issuance costs 1,094 4,550 Total interest expense $ 35,383 $ 24,793 Assuming the fourth quarter of 2023 interest rate of 13.91%, future payments on the 2027 Term Loans as of December 31, 2023, are as follows: Year ending December 31, (in thousands) 2024 - interest only $ 35,345 2025 - interest only 35,248 2026 - principal and interest 224,607 2027 - principal and interest 50,097 Total minimum payments 345,297 Less amount representing interest (95,297) 2027 Term Loans, gross 250,000 Less unamortized debt discount and debt issuance costs (3,519) Net carrying amount of 2027 Term Loans $ 246,481 The table above does not reflect any adjustment for transactions contemplated by the Consent and Amendment entered into on February 5, 2024, including any prepayments to the 2027 Term Loans. 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, 2023, 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 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. Since inception, the cap price has been $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 in 2020. 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, 2023, the holders of the 2026 Convertible Notes would have received common shares with an aggregate value of $39.8 million based on the Company’s closing stock price of $3.33 as of December 29, 2023. The following table presents the components of interest expense related to 2026 Convertible Notes: Year Ended December 31, (in thousands) 2023 2022 2021 Stated coupon interest $ 3,450 $ 3,450 $ 3,450 Amortization of debt discount and debt issuance costs 1,313 1,286 1,259 Total interest expense $ 4,763 $ 4,736 $ 4,709 The remaining unamortized debt discount and debt offering costs related to the Company’s 2026 Convertible Notes of $3.1 million as of December 31, 2023, will be amortized using the effective interest rate over the remaining term of the 2026 Convertible Notes. The annual effective interest rate is 2.1% for the 2026 Convertible Notes. Future payments on the 2026 Convertible Notes as of December 31, 2023 are as follows: Year ending December 31, (in thousands) 2024 - interest only $ 3,450 2025 - interest only 3,450 2026 - principal and interest 231,725 Total minimum payments 238,625 Less amount representing interest (8,625) 2026 Convertible Notes, principal amount 230,000 Less unamortized debt discount and debt issuance costs (3,112) Net carrying amount of 2026 Convertible Notes $ 226,888 8.2% Convertible Notes due 2022 On February 29, 2016, the Company issued and sold $100.0 million aggregate principal amount of its 8.2% Convertible Senior Notes due 2022. The 2022 Convertible Notes constituted general, senior unsubordinated obligations of the Company and were guaranteed by certain subsidiaries of the Company, bore interest at a fixed coupon rate of 8.2% per annum payable quarterly and matured on March 31, 2022 . In March 2022, the Company fully repaid the 2022 Convertible Notes, and as a result had no continuing obligations associated with them thereafter. The payoff amount of $111.1 million included the repayment of the entire outstanding principal amount, the 9.0% premium of the outstanding principal amount and accrued and unpaid interest. 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. The following table presents the components of interest expense of the 2022 Convertible Notes: Year Ended December 31, (in thousands) 2022 2021 Stated coupon interest $ 2,050 $ 8,200 Amortization of debt discount and debt issuance costs 521 1,966 Total interest expense $ 2,571 $ 10,166 2025 Term Loan On January 7, 2019, 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”). 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. 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 January 7, 2022, 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 statements of operations for 2022. The following table presents the components of interest expense of the 2025 Term Loan: Year Ended December 31, (in thousands) 2022 2021 Stated coupon interest $ 154 $ 7,034 Amortization of debt discount and debt issuance costs 16 1,032 Total interest expense $ 170 $ 8,066 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies. | |
Commitments and Contingencies | 9. 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, 2023, the Company’s non-cancelable purchase commitments under the terms of its agreements are as follows: Year ending December 31, (in thousands) 2024 $ 52,514 2025 19,154 2026 1,410 Total obligations $ 73,078 As of December 31, 2023, total obligations excludes certain purchase commitments that were assumed by Sandoz upon their acquisition of the Company’s CIMERLI ophthalmology franchise (see Note 17. Subsequent Events). 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 it’s 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. As of December 31, 2023 and 2022, the Company had an accrual of $6.4 million and $4.7 million, respectively, related to such matters 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, 2023 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 9, 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, 2023 | |
Leases | |
Leases | 10. Through December 31, 2023, the Company leased approximately 47,789 square feet of office space for its corporate headquarters in Redwood City, California (the “Lease Agreement”). Prior to an amendment to the Lease Agreement entered into on October 24, 2023 (the “Sixth Amendment”), the Lease Agreement was set to expire in September 2024 one The Company also leases approximately 25,017 square feet for its laboratory facilities in Camarillo, California which commenced in January 2020. This lease terminates in May 2027 one The Company determined that the above facility leases were operating leases. The options to extend the lease terms, if any, 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 leased approximately 50 vehicles as of December 31, 2023. 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. Beginning in February 2023, the Company no longer enters into these leasing arrangements and began transitioning to a reimbursement program with employees. Supplemental information related to the Company’s leases is as follows: (in thousands) December 31, Assets Balance Sheet Classification 2023 2022 Operating leases Other assets, non-current $ 5,912 $ 5,690 Finance leases Property and equipment, net 1,022 2,584 Total leased assets $ 6,934 $ 8,274 (in thousands) December 31, Liabilities Balance Sheet Classification 2023 2022 Operating lease liabilities, current Accrued and other current liabilities $ 1,424 $ 3,127 Operating lease liabilities, non-current Lease liabilities, non-current 4,977 3,628 Total operating lease liabilities $ 6,401 $ 6,755 Finance lease liabilities, current Accrued and other current liabilities $ 721 $ 1,191 Finance lease liabilities, non-current Lease liabilities, non-current 351 1,418 Total finance lease liabilities $ 1,072 $ 2,609 Other information related to lease term and discount rate is as follows: December 31, 2023 2022 2021 Weighted-Average Remaining Lease Term Operating leases 3.6 years 2.2 years 3.2 years Finance leases 1.4 years 2.2 years 1.7 years Weighted-Average Discount Rate Operating leases 11.8% 8.0% 8.0% Finance leases 8.7% 8.4% 5.8% The components of lease expense were as follows: Year Ended December 31, (in thousands) 2023 2022 2021 Finance lease cost Amortization of right-of-use assets $ 1,069 $ 1,228 $ 707 Interest on lease liabilities 146 166 82 Total finance lease cost 1,215 1,394 789 Operating lease cost 2,984 3,154 3,066 Total lease cost $ 4,199 $ 4,548 $ 3,855 Supplemental cash flow information related to leases was as follows: Year Ended December 31, (in thousands) 2023 2022 2021 Cash paid for amounts included in measurement of lease liabilities: Operating cash flows from operating leases $ 3,560 $ 3,401 $ 3,435 Operating cash flows from finance leases $ 145 $ 155 $ 81 Financing cash flows from finance leases $ 1,034 $ 1,228 $ 672 Right-of-use assets obtained in exchange for lease obligations: Operating leases $ 2,653 $ — $ 434 Finance leases $ — $ 2,694 $ 477 As of December 31, 2023, the maturities of the lease liabilities were as follows: Year ending December 31, (in thousands) Operating leases Finance leases 2024 $ 2,095 $ 781 2025 2,192 358 2026 2,126 — 2027 1,531 — Total lease payments 7,944 1,139 Less imputed interest (1,543) (67) Lease liabilities $ 6,401 $ 1,072 |
Stockholders' Deficit
Stockholders' Deficit | 12 Months Ended |
Dec. 31, 2023 | |
Equity [Abstract] | |
Stockholders' Deficit | 11. Stockholders’ Deficit Public Offering On May 16, 2023, the Company entered into the Underwriting Agreement with the Underwriters, pursuant to which the Company issued and sold the Firm Shares to the Underwriters. Additionally, under the terms of the Underwriting Agreement, the Company granted the Underwriters an option, for 30 days from the date of the Underwriting Agreement, to purchase the Option Shares, which the Underwriters elected to exercise in full. The price to the public in the Public Offering was $4.25 per share. The Underwriters agreed to purchase the Shares from the Company pursuant to the Underwriting Agreement at a price of $3.995 per share. The Offering was made pursuant to a prospectus supplement and related prospectus filed with the SEC pursuant to the Company’s Registration Statement under which 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. On May 18, 2023, the Company completed the sale and issuance of an aggregate of 13,529,411 Shares, including the exercise in full of the Underwriters’ option to purchase the Option Shares. The Company received net proceeds of approximately $53.6 million, after deducting the Underwriters’ discounts and commissions and offering expenses payable by the Company. ATM Offering On November 8, 2022, the Company filed a Registration Statement. 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. On May 15, 2023, pursuant to an Amendment No. 1 to Sales Agreement and in connection with the Public Offering, the Company reduced the number of shares that could be issued and sold pursuant to its ATM Offering with TD Cowen by $86.25 million, lowering the aggregate offering price under the Sales Agreement from $150.0 million to $63.75 million. On September 11, 2023, pursuant to an Amendment No. 2 to Sales Agreement, the Company increased the number of shares that could be issued and sold pursuant to its ATM Offering with TD Cowen by $28.75 million, increasing the aggregate offering price under the Sales Agreement from $63.75 million to $92.5 million. The following table summarizes information regarding settlements under the ATM Offering: Year Ended December 31, (in thousands, except share and per share data) 2023 2022 Number of common stock shares sold during the period 3,559,761 916,884 Weighted-average price per share $ 5.43 $ 7.30 Gross proceeds $ 19,339 $ 6,692 Less commissions and fees (483) (168) Net proceeds after commissions and fees $ 18,856 $ 6,524 As of December 31, 2023, the Company had approximately $66.5 million of its common stock remaining available for sales under the ATM Offering. Common Stock On October 9, 2023, in accordance with the terms of the Optional Stock Purchase Agreement, the Company issued 2,225,513 shares of its common stock to the CMO for a price of $3.675 per share, with a total value of $8.2 million in this non-cash transaction. The Optional Stock Purchase Agreement gave the Company the option, in its sole discretion, to elect to pay for certain manufacturing services provided by the CMO by either paying cash or a Stock Service Fee Payment. On October 4, 2023, the Company notified the CMO of its election of the Stock Service Fee Payment. The price per share of common stock was equal to the volume-weighted average closing trading price per share of common stock on the Nasdaq Global Market over the ten -trading day period ending on and including October 6, 2023. |
Stock-Based Compensation and Em
Stock-Based Compensation and Employee Benefits | 12 Months Ended |
Dec. 31, 2023 | |
Stock-Based Compensation and Employee Benefits | |
Stock-Based Compensation and Employee Benefits | 12. 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 with 2024 being the last calendar year with an automatic annual increase under the 2014 Plan. 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, primarily 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, 2023. There were 881,231 shares of common stock available for future issuance as of December 31, 2023 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, 2023, the Company had 1,773,921 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 depending 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, 2022 21,691,321 $ 15.00 Granted - at fair value 5,947,607 $ 6.86 Exercised (430,504) $ 1.61 Forfeited/Canceled (3,549,184) $ 14.25 Outstanding at December 31, 2023 23,659,240 $ 13.31 5.7 $ 2,337 Exercisable at December 31, 2023 16,279,679 $ 15.20 4.3 $ 1,815 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, 2023 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 $ 1.67 - $ 5.44 4,288,840 6.9 $ 3.92 1,356,589 $ 2.32 $ 5.86 - $ 10.05 4,493,996 6.5 $ 9.20 2,436,570 $ 9.45 $ 10.37 - $ 13.63 4,143,765 5.6 $ 12.41 3,317,635 $ 12.53 $ 14.03 - $ 17.17 4,436,113 5.8 $ 15.82 3,304,217 $ 15.86 $ 17.30 - $ 19.40 3,827,172 5.5 $ 17.96 3,403,068 $ 17.95 $ 19.85 - $ 46.38 2,469,354 2.1 $ 26.90 2,461,600 $ 26.91 23,659,240 5.7 $ 13.31 16,279,679 $ 15.20 Additional information on options is summarized as follows: Year Ended December 31, (in thousands, except weighted-average grant-date fair value per share) 2023 2022 2021 Total intrinsic value of options exercised $ 425 $ 914 $ 9,726 Total grant date fair value of options vested $ 30,467 $ 34,916 $ 40,365 Weighted-average grant date fair value per share of options granted $ 4.19 $ 7.04 $ 9.80 As of December 31, 2023, total unrecognized stock-based compensation expense related to unvested stock options was $37.4 million, which is expected to be recognized over a weighted-average period of 2.3 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 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, 2022 2,333,307 $ 14.66 RSUs granted 1,274,753 $ 8.93 RSUs vested (1,280,901) $ 14.35 RSUs canceled (600,430) $ 11.02 Balances at December 31, 2023 1,726,729 $ 11.93 Additional information on RSUs is summarized as follows: Year Ended December 31, (in thousands, except weighted-average grant-date fair value per share) 2023 2022 2021 Total grant date fair value of RSUs vested $ 18,381 $ 13,598 $ 8,434 Total grant date fair value of RSUs granted $ 11,386 $ 22,502 $ 27,869 Weighted-average grant-date fair value per share of RSUs granted $ 8.93 $ 13.34 $ 16.86 As of December 31, 2023, total unrecognized stock-based compensation expense related to unvested RSUs was $10.8 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 2,541,769 shares of common stock available for future issuance as of December 31, 2023. 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 statements of operations related to employees and nonemployees: Year Ended December 31, (in thousands) 2023 2022 2021 Cost of goods sold (1) $ 632 $ 736 $ 1,099 Research and development 14,596 18,999 18,688 Selling, general and administrative 27,882 31,002 31,577 Stock-based compensation expense $ 43,110 $ 50,737 $ 51,364 Stock-based compensation expense capitalized into inventory $ 1,062 $ 1,187 $ 1,025 (1) Stock-based compensation capitalized into inventory is recognized as cost of goods sold when the related product is sold. The stock-based compensation for the year ended December 31, 2023 includes restructuring charges described in Note 15 of $1.1 million in research and development expense and a net forfeiture credit of $0.1 million in selling, general and administrative expense. The stock-based compensation expense recorded in connection with the Surface Acquisition that was not included in the consideration transferred was immaterial. 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, 2023, 2022 and 2021: Year Ended December 31, 2023 2022 2021 Expected term (years) Stock options 6.0 6.1 6.1 ESPP 0.5 0.5 0.5 Expected volatility Stock options 64 % 62 % 65 % ESPP 105 % 70 % 42 % Risk-free interest rate Stock options 3.92 % 2.37 % 0.89 % ESPP 5.35 % 3.77 % 0.06 % 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 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. The Company recorded compensation expense related to the match of $1.8 million, $2.1 million and $1.7 million in 2023, 2022 and 2021, respectively. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2023 | |
Income Taxes | |
Income Taxes | 13. The components of loss before income taxes are as follows: Year Ended December 31, (in thousands) 2023 2022 2021 Domestic $ (238,272) $ (291,746) $ (287,058) Foreign — (8) (42) Total $ (238,272) $ (291,754) $ (287,100) For the periods presented, the income tax provision (benefit) is as follows: Year Ended December 31, (in thousands) 2023 2022 2021 Current: Federal $ — $ — $ — State — — — Foreign — — — Subtotal $ — $ — $ — Deferred: Federal $ (380) $ — $ — State — — — Foreign — — — Subtotal $ (380) $ — $ — Income tax provision (benefit) $ (380) $ — $ — 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. A reconciliation of the statutory United States federal rate to the Company’s effective tax rate is as follows: Year Ended December 31, 2023 2022 2021 Percent of pre-tax income: United States federal statutory income tax rate 21.0 % 21.0 % 21.0 % State taxes, net of federal benefit (1.2) 1.7 2.6 Foreign rate differences — — — Permanent items — (0.1) 0.2 Research and development credit 0.9 1.8 2.6 Stock-based compensation costs (3.5) (2.3) (1.2) Other 0.7 — — Change in valuation allowance (17.7) (22.1) (25.2) Effective income tax rate 0.2 % — % — % The components of the Company’s net deferred tax assets as of December 31, 2023 and 2022 consist of the following: December 31, (in thousands) 2023 2022 Net operating loss carryforwards $ 170,402 $ 131,423 Research and development credits 65,225 63,164 Depreciation and amortization 37,211 51,877 Stock-based compensation 30,370 32,561 Sales related accruals 38,474 23,864 Other accruals 42,480 19,717 Capitalized research and development 46,062 17,673 Gross deferred tax assets 430,224 340,279 Right-of-use asset (1,538) (1,903) In-process research and development (6,403) (603) Gross deferred tax liabilities (7,941) (2,506) Total net deferred tax asset 422,283 337,773 Less valuation allowance (423,385) (337,773) Net deferred tax assets (liabilities) $ (1,102) $ — 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 offset the federal and certain state net deferred tax assets by a valuation allowance as of December 31, 2023 and 2022. The valuation allowance increased by $85.6 million, $64.4 million and $72.4 million during the years ended December 31, 2023, 2022 and 2021, respectively. As of December 31, 2023, the Company had net operating loss carryforwards for federal income of $774.9 million, which will start to expire in the year 2036, and various states net operating loss carryforwards of $128.0 million, which have various expiration dates beginning in 2031. As of December 31, 2023, the Company had federal research and development credit carryforwards for federal income tax purposes of $60.6 million, which will start to expire in the year 2031, and state research and development credit carryforwards of $26.5 million, which have no expiration date. Utilization of the net operating loss and tax credit carryforwards may be subject to a substantial annual limitation due to ownership change limitations provided by Section 382 of 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 inception in 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 2023, 2022 and 2021 is as follows: Year Ended December 31, (in thousands) 2023 2022 2021 Balance at beginning of year $ 16,838 $ 15,495 $ 13,243 Additions based on tax positions related to current year 865 1,385 2,038 Additions (reductions) for tax positions of prior years (286) (42) 214 Balance at end of year $ 17,417 $ 16,838 $ 15,495 As of December 31, 2023, 2022 and 2021, the Company had $17.4 million, $16.8 million and $15.5 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 2023, 2022 and 2021, 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 Per Share
Net Loss Per Share | 12 Months Ended |
Dec. 31, 2023 | |
Net Loss Per Share | |
Net Loss Per Share | 14. The following outstanding dilutive potential shares were excluded from the calculation of diluted net loss per share due to their anti-dilutive effect: Year Ended December 31, 2023 2022 2021 Stock options, including shares subject to ESPP 24,083,222 22,214,875 19,895,097 Restricted stock units 2,266,387 2,399,465 1,811,607 Shares issuable upon conversion of 2022 Convertible Notes — 1,078,632 4,473,871 Shares issuable upon conversion of 2026 Convertible Notes 11,942,152 11,942,152 11,942,152 Total 38,291,761 37,635,124 38,122,727 |
Restructuring Charges
Restructuring Charges | 12 Months Ended |
Dec. 31, 2023 | |
Restructuring Charges. | |
Restructuring Charges | 15. Restructuring Charges On March 3, 2023, the Company committed to a plan to reduce its workforce to focus resources on strategic priorities including the commercialization of its diversified product portfolio and development of innovative immuno-oncology product candidates. The reduction in force impacted approximately 50 full-time and part-time employees, effective March 10, 2023 for most of these employees. In the first quarter of 2023, non-recurring restructuring charges associated with the reduction in force consisted of $3.9 million in cash expenses related to personnel expenses such as salaries, severance payments and other benefits; and $1.5 million in non-cash stock-based compensation related to acceleration of vesting and extension of the stock option exercise windows for two impacted executives; partially offset by $0.5 million in non-cash stock-based compensation forfeiture credits. The reduction in force was completed during the second quarter of 2023. For the year ended December 31, 2023, the consolidated statements of operations include $3.6 million in research and development expense and $1.3 million in selling, general and administrative expense related to the reduction in force. |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2023 | |
Related Party Transactions | |
Related Party Transactions | 16. 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 7. 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 in 2021 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, 2023 and 2022. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2023 | |
Subsequent Events | |
Subsequent Events | 17. Subsequent Events CIMERLI Sale Transaction On January 19, 2024, the Company entered into the Purchase Agreement by and between the Company and Sandoz. Pursuant to the terms and subject to the conditions set forth in the Purchase Agreement, on March 1, 2024, the Company completed the Sale Transaction for its CIMERLI ophthalmology franchise through the sale of its subsidiary, Coherus Ophthalmology LLC, to Sandoz for upfront, all-cash consideration of $170.0 million plus an additional $17.8 million for CIMERLI product inventory and prepaid manufacturing assets. Such consideration is subject to certain adjustments that will be finalized following the closing pursuant to the Purchase Agreement. Partial Release and Third Amendment to 2027 Term Loan On February 5, 2024, the Company, entered into the Consent and Amendment with the Collateral Agent and the Lenders, pursuant to which the Lenders and the Collateral Agent provided certain consents, and released certain assets and subsidiaries of the Company from their obligations under the 2027 Term Loans and the other loan documents in connection therewith, and the parties thereto agreed to amend the Loan Agreement. Pursuant to and subject to terms and conditions in the Consent and Amendment, among other things: (1) the Lenders and the Collateral Agent provided consent to consummation of the transactions contemplated by the Purchase Agreement, and released certain subsidiary of the Company from its obligation and certain assets subject to the transactions contemplated thereby, (2) the Lenders and the Collateral Agent permitted the Company to make a partial prepayment of the principal of the loans outstanding under the 2027 Term Loans in the amount of $175.0 million upon consummation of the transactions contemplated by the Purchase Agreement, subject to certain conditions including a prepayment premium and makewhole amount calculated pursuant to the Consent and Amendment and (3) the parties thereto agreed to adjust the minimum net sales covenant level under the 2027 Term Loans. Upon the closing of the Sale Transaction the Company became liable to repay $175.0 million of the existing principal balance of $250.0 million of the loans outstanding under the Loan Agreement on April 1, 2024 and the Company plans to repay $175.0 million and the prepayment premium and makewhole amount of $6.8 million to the Lenders on or before April 1, 2024 pursuant to the Consent and Amendment. Other terms of the 2027 Term Loans, as amended by the Consent and Amendment, remain generally identical to those under the 2027 Term Loans. |
Organization and Summary of S_2
Organization and Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Organization and Summary of 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 interest 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. 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: 2023 2022 2021 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 December 31, At end of period: 2023 2022 2021 Cash and cash equivalents $ 102,891 $ 63,547 $ 417,195 Restricted cash 452 440 440 Total cash, cash equivalents and restricted cash $ 103,343 $ 63,987 $ 417,635 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 used in investing activities in its consolidated statements of cash flows. |
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, 2023 and 2022. |
Investments in Marketable Securities | Investments in Marketable Securities Investments in marketable securities primarily consist of U.S. Treasury securities, government agency securities, commercial paper, corporate bonds and market money funds. 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 2023, 2022 and 2021, interest income from marketable securities was $2.8 million, $1.9 million and $1.4 million, respectively, and is included in other income (expense), net, in the consolidated statements of operations. |
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. During 2023, the products sold by the Company were UDENYCA, CIMERLI, YUSIMRY and LOQTORZI. During 2022, UDENYCA and CIMERLI were the only products sold by the Company, and in 2021 UDENYCA accounted for all of the Company’s revenues. 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. |
Derivative Instruments | Derivative Instruments In January 2023, the Company commenced using derivative contracts (foreign exchange option contracts) for the purpose of economically hedging exposure to changes in currency fluctuations between the U.S. Dollar and the Euro. The Company recognizes all derivatives at fair value on the consolidated balance sheets, and corresponding gains and losses are recognized in other income (expense), net in the consolidated statements of operations. The estimated fair value of derivative financial instruments represents the amount required to enter into similar contracts with similar remaining maturities based on quoted market prices. During the periods presented, the Company did not apply hedge accounting to these instruments. There are no derivative instruments entered into for speculative or trading purposes. Since the Company's foreign exchange derivatives all matured and settled by December 31, 2023, there were no derivative assets or derivative liabilities |
Business Combination Accounting & Valuation of Acquired Assets | Business Combination Accounting & Valuation of Acquired Assets The Company accounts for acquisitions of entities that include inputs and processes and have the ability to create outputs as business combinations. Judgment is required in assessing whether the acquired processes or activities, along with their inputs, meet the criteria to constitute a business, as defined by U.S. GAAP. The acquisition method of accounting requires the recognition of assets acquired and liabilities assumed at their acquisition date fair values. The excess of the fair value of consideration transferred over the fair value of the net assets acquired is recorded as goodwill, or when there is an excess of the fair values of these identifiable assets and liabilities over the fair value of purchase consideration, a bargain purchase gain is recorded in the consolidated statements of operations. The estimations of fair values based on non-observable inputs that are included in valuation models. An income approach, which generally relies upon projected cash flow models, is used in estimating the fair value of the acquired intangible assets. These cash flow projections are based on management's estimates of economic and market conditions including the estimated future cash flows from revenues of acquired assets, the timing and projection of costs and expenses and the related profit margins, tax rates, and discount rate. During the measurement period, which occurs before finalization of the purchase price allocation, changes in assumptions and estimates that result in adjustments to the fair values of assets acquired and liabilities assumed, if based on facts and circumstances existing at the acquisition date, are recorded on a retroactive basis as of the acquisition date, with the corresponding offset to goodwill or bargain purchase gain (See Note 6. Surface Acquisition). |
Foreign Currency | Foreign Currency Monetary assets and liabilities denominated in foreign currency are remeasured at period-end exchange rates. 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 experienced material foreign currency transaction gains and losses for any of the 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 2023 and 2022, the Company recorded $52.6 million and $26.0 million in inventory write-downs, respectively, within cost of goods sold in the consolidated statements of operations. The 2023 charge was primarily for the write-down of slow moving YUSIMRY inventory and the related partial recognition of certain firm purchase commitments. The 2022 charge was due to the competitive environment and lower demand for UDENYCA resulting in certain inventory becoming at risk of expiration. 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 statements 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 incurs expenses for the manufacture of drug products 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, 2023 was related to UDENYCA, YUSIMRY, CIMERLI and LOQTORZI. |
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. 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 commence amortization over the useful life of the intangible asset, which will generally be determined by the period in which the substantial majority of the cash flows are expected to be generated. Finite-lived intangible assets are generally amortized on a straight-line basis over their estimated economic life and are reviewed periodically for impairment. The amortization expense related to capitalized milestone payments under license agreements and the amortization expense from out-licenses are recorded as a component of cost of goods sold in the consolidated statements of operations. The estimated life for capitalized milestone payments is ten years, and the life for acquired out-licenses is fifteen years. |
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. |
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. |
Contingent Consideration | Contingent Consideration Contingent consideration relates to the potential payments to holders of the CVRs that are contingent upon the achievement of the Company and certain third-parties meeting product development or financial performance milestones. For transactions accounted for as business combinations, the Company records contingent consideration at fair value at the date of the acquisition based on the consideration expected to be transferred. Liabilities for contingent consideration are remeasured each reporting period and subsequent changes in fair value are recognized within loss from operations in the consolidated statements of operations. The assumptions utilized in the calculation of the fair values include probability of success and the discount rates. Contingent consideration involves certain assumptions requiring significant judgment and actual results may differ from estimated amounts. |
Net Revenues | 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 and non-current liabilities (if the amounts are payable to a party other than a Customer). Where appropriate, these estimates take into consideration a range of possible outcomes that are probability-weighted for relevant factors such as historical experience, current contractual and statutory requirements, specifically known market events and trends, industry data and forecasted Customer buying and payment patterns. Overall, these reserves reflect the best estimates of the amount of consideration to which the Company is entitled based on the terms of its contracts. The amount of variable consideration that is included in the transaction price may be constrained, and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. The actual amount of consideration ultimately received may differ. If actual results in the future vary from the Company’s estimates, the estimates will be adjusted, which will affect net product revenue in the period that such variances become known. Chargebacks: Discounts for Prompt Payment: Rebates: Co-payment Assistance: Product Returns: Other Allowances: Royalty Revenue Royalty revenue from licensees, which is based on sales to third parties of licensed products, is recorded when the third-party sale occurs and the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). Royalty revenue was immaterial 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, certain overhead costs, royalties on certain products, and charges for inventory write-downs. 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 UDENYCA 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. The Company incurs royalties on net sales of LOQTORZI in the low- to mid-twenty percent range and on net sales of YUSIMRY in the mid-single digit range. Pursuant to the Genentech Agreement, the Company incurred a royalty that was a low single-digit percentage of net sales of CIMERLI through the end of 2023. In 2023, 2022 and 2021, cost of goods sold included inventory write-downs, net of $52.6 million, $26.0 million and $5.1 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 $10.9 million, $10.5 million and $8.7 million in 2023, 2022 and 2021, 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. The Company accounts for stock issued in connection with business combinations based on the fair value of the Company’s common stock on the date of issuance. |
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 2024. |
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 or the lease modification date, as applicable, in determining the lease liabilities as the Company's leases generally do not provide an implicit rate. |
Net Loss per Share | Net Loss Per Share Basic net loss per share is calculated by dividing the net loss by the weighted-average number of shares of common stock outstanding for the period, without consideration for potential dilutive common shares. 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 | Comprehensive Loss Comprehensive loss includes the following two components: net loss and other comprehensive income (loss). Other comprehensive income (loss) refers to gains and losses that are recorded as an element of stockholders’ equity (deficit), but are excluded from net loss. The Company’s other comprehensive income (loss) includes unrealized gains on available-for-sale securities and foreign currency translation adjustments in 2023, 2022 and 2021. |
Reclassifications | Reclassifications Certain amounts in prior years’ financial statements have been reclassified to conform with the current year presentation in 2023, including amounts in the consolidated statements of cash flows. There were no changes to net cash used in operating activities in the consolidated statements of cash flows for the prior years as a result. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements The following are recent accounting pronouncements that the Company has not yet adopted: In November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-07, Segment Reporting (Topic 280) Improvements to Reportable Segment Disclosures In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures The Company has reviewed other recent accounting pronouncements and concluded they are either not applicable to the business or that no material effect is expected on the consolidated financial statements as a result of future adoption. |
Organization and Summary of S_3
Organization and Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Organization and Summary of Significant Accounting Policies | |
Schedule of Reconciliation of Cash, Cash Equivalents and Restricted Cash | (in thousands) January 1, At beginning of period: 2023 2022 2021 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 December 31, At end of period: 2023 2022 2021 Cash and cash equivalents $ 102,891 $ 63,547 $ 417,195 Restricted cash 452 440 440 Total cash, cash equivalents and restricted cash $ 103,343 $ 63,987 $ 417,635 |
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, 2023 | |
Revenue | |
Schedule of Net product revenue in United States, and Company's net revenue | Year Ended December 31, (in thousands) 2023 2022 2021 Products UDENYCA $ 127,064 $ 203,814 $ 326,509 CIMERLI 125,388 6,946 — YUSIMRY 3,574 — — LOQTORZI 554 — — Total net product revenue 256,580 210,760 326,509 Other 664 282 42 Total net revenue $ 257,244 $ 211,042 $ 326,551 |
Schedule of Gross Revenues by Significant Customer as a Percentage of Total Gross Revenues | Year Ended December 31, 2023 2022 2021 McKesson Corporation 40 % 38 % 39 % Cencora (previously known as AmeriSource-Bergen Corporation) 43 % 44 % 39 % Cardinal Health, Inc. 15 % 17 % 20 % |
Schedule of Activities and Ending Reserve Balances for Each Significant Category of Discounts and Allowances | 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 - increase (decrease) (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 Provision related to sales made in: Current period 436,865 68,399 73,435 578,699 Prior period - increase (decrease) (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 Provision related to sales made in: Current period 590,772 143,370 110,183 844,325 Prior period - increase (decrease) (1,361) 1,424 3,744 3,807 Payments and customer credits issued (558,135) (62,370) (83,245) (703,750) Balances at December 31, 2023 $ 73,953 $ 121,137 $ 49,795 $ 244,885 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Measurements | |
Schedule of Financial Assets and Liabilities Measured on a Recurring Basis | Fair Value Measurements December 31, 2023 (in thousands) Level 1 Level 2 Level 3 Total Financial Assets: Cash equivalents (1) $ 88,460 $ 998 $ — $ 89,458 Marketable debt securities: U.S. government agency securities 5,195 — — 5,195 U.S. treasury securities 2,993 — — 2,993 Commercial paper and corporate notes — 6,669 — 6,669 Prepaid financial instrument in Prepaid manufacturing (2) — — 625 625 Total $ 96,648 $ 7,667 $ 625 $ 104,940 Financial Liabilities: Contingent consideration $ — $ — $ 4,472 $ 4,472 Fair Value Measurements December 31, 2022 (in thousands) Level 1 Level 2 Level 3 Total Financial Assets: Cash equivalents (1) $ 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 (1) Cash equivalents consist of money market funds, U.S treasury securities, and commercial paper and corporate notes with original maturities of 90 days or less. (2) Relates to Optional Stock Purchase Agreement. |
Schedule of Cash and cash equivalents, marketable securities and restricted cash | December 31, 2023 (in thousands) Cost Unrealized Gain Unrealized (Loss) Fair Value Money market funds $ 79,484 $ — $ — $ 79,484 U.S. government agency securities 5,200 — (5) 5,195 U.S. treasury securities 11,967 2 — 11,969 Commercial paper and corporate notes 7,673 — (6) 7,667 Total $ 104,324 $ 2 $ (11) $ 104,315 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, 2023 | |
Inventory | |
Schedule of Inventory | December 31, (in thousands) 2023 2022 Raw materials $ 12,975 $ 10,262 Work in process 82,588 86,712 Finished goods 34,537 18,077 Total $ 130,100 $ 115,051 |
Schedule of Balance Sheet Classification | December 31, (in thousands) 2023 2022 Inventory $ 62,605 $ 38,791 Inventory, non-current 67,495 76,260 Total $ 130,100 $ 115,051 |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Organization and Operations | |
Schedule of Property and Equipment, Net | December 31, (in thousands) 2023 2022 Machinery and equipment $ 13,124 $ 12,944 Computer equipment and software 3,546 3,183 Furniture and fixtures 1,055 1,258 Leasehold improvements 5,751 6,198 Finance lease right of use assets 2,294 4,632 Construction in progress — 696 Total property and equipment 25,770 28,911 Accumulated depreciation and amortization (20,651) (20,157) Property and equipment, net $ 5,119 $ 8,754 |
Schedule of Goodwill and Intangible Assets, Net | December 31, (in thousands) 2023 2022 Finite-lived assets, net of accumulated amortization of $639 and $61, respectively $ 41,871 $ 2,368 Indefinite-lived assets - IPR&D 28,859 2,620 Goodwill 943 943 Total Intangible assets, net $ 71,673 $ 5,931 |
Schedule of Accrued Liabilities | December 31, December 31, (in thousands) 2023 2022 Accrued commercial and research and development manufacturing $ 23,470 $ 21,774 Accrued co-development costs and milestone payments 26,812 8,356 Accrued royalties 42,031 5,015 Accrued other 7,628 10,634 Lease liabilities, current 2,145 4,318 Contingent consideration, current 3,300 — Total Accrued and other current liabilities $ 105,386 $ 50,097 |
Schedule of Other Liabilities, Non-current | December 31, December 31, (in thousands) 2023 2022 Contingent consideration, non-current $ 1,172 $ 102 Deferred tax liability 1,102 — Other 10,287 3,365 Total Other liabilities, non-current $ 12,561 $ 3,467 |
Surface Acquisition (Tables)
Surface Acquisition (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Surface Acquisition | |
Schedule of total consideration paid | (in thousands, except share and per share amounts) As of Acquisition Date Coherus common stock issued 11,971,460 Coherus common stock share price $ 4.89 Fair value of components of purchase price consideration at closing: Equity of combined company owned by Surface equity holders $ 58,540 Contingent CVR liability 5,290 Equity of combined company owned by Surface former employees (1) 766 Fair value of total purchase consideration $ 64,596 (1) Represents 161,100 shares of Coherus common stock, net of shares withheld for taxes, issued to Surface’s former employees on the Acquisition Date. |
Schedule of purchase price allocation to the estimated fair value of the net assets acquired | (in thousands) Amounts Recognized at Acquisition Date Assets Acquired Cash and cash equivalents $ 6,997 Investments in marketable securities 21,791 Other prepaids and other assets 5,260 In-process research and development 26,239 Out-licenses 13,530 Total assets $ 73,817 Liabilities Assumed Accrued and other current liabilities $ 7,722 Deferred tax liability 1,499 Total liabilities 9,221 Total net assets acquired $ 64,596 |
Schedule of amount allocated to identifiable intangible assets | (in thousands) Useful lives Fair Value at Acquisition Date In-process research and development - casdozokitug n/a $ 25,899 In-process research and development - CHS-114 n/a 340 Out-license - GSK 15 years 2,506 Out-license - Novartis Institutes 15 years 11,024 Total identifiable intangible assets $ 39,769 |
Schedule of pro forma information does not purport to represent what the Company's actual results would have been if the acquisition had occurred as of January 1, 2022 | Year Ended December 31, (in thousands) 2023 2022 Total revenues $ 257,244 $ 241,042 Net loss $ (284,575) $ (369,442) |
Debt Obligations (Tables)
Debt Obligations (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Debt Instrument | |
Schedule of Company's Debt Obligations | At December 31, 2023 (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 $ (3,519) $ 246,481 $ 246,481 Level 2* 2026 Convertible Notes $ 230,000 $ (3,112) $ 226,888 $ 150,155 Level 2** 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** * The principal amounts outstanding are subject to variable interest rates, which are based on three-month SOFR starting April 1, 2023 plus fixed percentages. Through March 31, 2023, the variable component was based on the three-month LIBOR. Therefore, the Company believes the carrying amount of these obligations approximates fair value. ** |
2027 Term Loans | |
Debt Instrument | |
Schedule of Components of Interest Expense | Year Ended December 31, (in thousands) 2023 2022 Contractual interest $ 34,289 $ 20,243 Amortization of debt discount and debt issuance costs 1,094 4,550 Total interest expense $ 35,383 $ 24,793 |
Schedule of Future Payments on Debt | Year ending December 31, (in thousands) 2024 - interest only $ 35,345 2025 - interest only 35,248 2026 - principal and interest 224,607 2027 - principal and interest 50,097 Total minimum payments 345,297 Less amount representing interest (95,297) 2027 Term Loans, gross 250,000 Less unamortized debt discount and debt issuance costs (3,519) Net carrying amount of 2027 Term Loans $ 246,481 |
1.5% Convertible Senior Subordinated Notes due 2026 | |
Debt Instrument | |
Schedule of Components of Interest Expense | Year Ended December 31, (in thousands) 2023 2022 2021 Stated coupon interest $ 3,450 $ 3,450 $ 3,450 Amortization of debt discount and debt issuance costs 1,313 1,286 1,259 Total interest expense $ 4,763 $ 4,736 $ 4,709 |
Schedule of Future Payments on Debt | Future payments on the 2026 Convertible Notes as of December 31, 2023 are as follows: Year ending December 31, (in thousands) 2024 - interest only $ 3,450 2025 - interest only 3,450 2026 - principal and interest 231,725 Total minimum payments 238,625 Less amount representing interest (8,625) 2026 Convertible Notes, principal amount 230,000 Less unamortized debt discount and debt issuance costs (3,112) Net carrying amount of 2026 Convertible Notes $ 226,888 |
8.2% Convertible Notes due 2022 | |
Debt Instrument | |
Schedule of Components of Interest Expense | Year Ended December 31, (in thousands) 2022 2021 Stated coupon interest $ 2,050 $ 8,200 Amortization of debt discount and debt issuance costs 521 1,966 Total interest expense $ 2,571 $ 10,166 |
2025 Term Loan | |
Debt Instrument | |
Schedule of Components of Interest Expense | Year Ended December 31, (in thousands) 2022 2021 Stated coupon interest $ 154 $ 7,034 Amortization of debt discount and debt issuance costs 16 1,032 Total interest expense $ 170 $ 8,066 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies. | |
Schedule of Non-cancelable Contractual Obligations | Year ending December 31, (in thousands) 2024 $ 52,514 2025 19,154 2026 1,410 Total obligations $ 73,078 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Leases | |
Schedule of Balance Sheet Classification of Lease Assets and Liabilities | (in thousands) December 31, Assets Balance Sheet Classification 2023 2022 Operating leases Other assets, non-current $ 5,912 $ 5,690 Finance leases Property and equipment, net 1,022 2,584 Total leased assets $ 6,934 $ 8,274 (in thousands) December 31, Liabilities Balance Sheet Classification 2023 2022 Operating lease liabilities, current Accrued and other current liabilities $ 1,424 $ 3,127 Operating lease liabilities, non-current Lease liabilities, non-current 4,977 3,628 Total operating lease liabilities $ 6,401 $ 6,755 Finance lease liabilities, current Accrued and other current liabilities $ 721 $ 1,191 Finance lease liabilities, non-current Lease liabilities, non-current 351 1,418 Total finance lease liabilities $ 1,072 $ 2,609 |
Other information related to lease term and discount rate | December 31, 2023 2022 2021 Weighted-Average Remaining Lease Term Operating leases 3.6 years 2.2 years 3.2 years Finance leases 1.4 years 2.2 years 1.7 years Weighted-Average Discount Rate Operating leases 11.8% 8.0% 8.0% Finance leases 8.7% 8.4% 5.8% |
Components of lease expense | Year Ended December 31, (in thousands) 2023 2022 2021 Finance lease cost Amortization of right-of-use assets $ 1,069 $ 1,228 $ 707 Interest on lease liabilities 146 166 82 Total finance lease cost 1,215 1,394 789 Operating lease cost 2,984 3,154 3,066 Total lease cost $ 4,199 $ 4,548 $ 3,855 |
Supplemental cash flow information related to leases | Year Ended December 31, (in thousands) 2023 2022 2021 Cash paid for amounts included in measurement of lease liabilities: Operating cash flows from operating leases $ 3,560 $ 3,401 $ 3,435 Operating cash flows from finance leases $ 145 $ 155 $ 81 Financing cash flows from finance leases $ 1,034 $ 1,228 $ 672 Right-of-use assets obtained in exchange for lease obligations: Operating leases $ 2,653 $ — $ 434 Finance leases $ — $ 2,694 $ 477 |
Schedule of maturities of operating and finance lease liabilities | Year ending December 31, (in thousands) Operating leases Finance leases 2024 $ 2,095 $ 781 2025 2,192 358 2026 2,126 — 2027 1,531 — Total lease payments 7,944 1,139 Less imputed interest (1,543) (67) Lease liabilities $ 6,401 $ 1,072 |
Stockholders' Deficit (Tables)
Stockholders' Deficit (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Equity [Abstract] | |
Schedule of Settlements Under the ATM Offering | Year Ended December 31, (in thousands, except share and per share data) 2023 2022 Number of common stock shares sold during the period 3,559,761 916,884 Weighted-average price per share $ 5.43 $ 7.30 Gross proceeds $ 19,339 $ 6,692 Less commissions and fees (483) (168) Net proceeds after commissions and fees $ 18,856 $ 6,524 |
Stock-Based Compensation and _2
Stock-Based Compensation and Employee Benefits (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
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, 2022 21,691,321 $ 15.00 Granted - at fair value 5,947,607 $ 6.86 Exercised (430,504) $ 1.61 Forfeited/Canceled (3,549,184) $ 14.25 Outstanding at December 31, 2023 23,659,240 $ 13.31 5.7 $ 2,337 Exercisable at December 31, 2023 16,279,679 $ 15.20 4.3 $ 1,815 |
Schedule of options outstanding and exercisable | Information on options outstanding and exercisable as of December 31, 2023 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 $ 1.67 - $ 5.44 4,288,840 6.9 $ 3.92 1,356,589 $ 2.32 $ 5.86 - $ 10.05 4,493,996 6.5 $ 9.20 2,436,570 $ 9.45 $ 10.37 - $ 13.63 4,143,765 5.6 $ 12.41 3,317,635 $ 12.53 $ 14.03 - $ 17.17 4,436,113 5.8 $ 15.82 3,304,217 $ 15.86 $ 17.30 - $ 19.40 3,827,172 5.5 $ 17.96 3,403,068 $ 17.95 $ 19.85 - $ 46.38 2,469,354 2.1 $ 26.90 2,461,600 $ 26.91 23,659,240 5.7 $ 13.31 16,279,679 $ 15.20 |
Schedule of additional information on options | Year Ended December 31, (in thousands, except weighted-average grant-date fair value per share) 2023 2022 2021 Total intrinsic value of options exercised $ 425 $ 914 $ 9,726 Total grant date fair value of options vested $ 30,467 $ 34,916 $ 40,365 Weighted-average grant date fair value per share of options granted $ 4.19 $ 7.04 $ 9.80 |
Summary of RSU Activity, under 2014 Plan | RSUs Outstanding Weighted-Average Number of Grant Date Fair RSUs Value Balances at December 31, 2022 2,333,307 $ 14.66 RSUs granted 1,274,753 $ 8.93 RSUs vested (1,280,901) $ 14.35 RSUs canceled (600,430) $ 11.02 Balances at December 31, 2023 1,726,729 $ 11.93 Year Ended December 31, (in thousands, except weighted-average grant-date fair value per share) 2023 2022 2021 Total grant date fair value of RSUs vested $ 18,381 $ 13,598 $ 8,434 Total grant date fair value of RSUs granted $ 11,386 $ 22,502 $ 27,869 Weighted-average grant-date fair value per share of RSUs granted $ 8.93 $ 13.34 $ 16.86 |
Schedule of Stock-Based Compensation Expense | Year Ended December 31, (in thousands) 2023 2022 2021 Cost of goods sold (1) $ 632 $ 736 $ 1,099 Research and development 14,596 18,999 18,688 Selling, general and administrative 27,882 31,002 31,577 Stock-based compensation expense $ 43,110 $ 50,737 $ 51,364 Stock-based compensation expense capitalized into inventory $ 1,062 $ 1,187 $ 1,025 (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, 2023 2022 2021 Expected term (years) Stock options 6.0 6.1 6.1 ESPP 0.5 0.5 0.5 Expected volatility Stock options 64 % 62 % 65 % ESPP 105 % 70 % 42 % Risk-free interest rate Stock options 3.92 % 2.37 % 0.89 % ESPP 5.35 % 3.77 % 0.06 % Expected dividend yield Stock options — % — % — % ESPP — % — % — % |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Income Taxes | |
Components of loss before income taxes | Year Ended December 31, (in thousands) 2023 2022 2021 Domestic $ (238,272) $ (291,746) $ (287,058) Foreign — (8) (42) Total $ (238,272) $ (291,754) $ (287,100) |
Income tax provision (benefit) | Year Ended December 31, (in thousands) 2023 2022 2021 Current: Federal $ — $ — $ — State — — — Foreign — — — Subtotal $ — $ — $ — Deferred: Federal $ (380) $ — $ — State — — — Foreign — — — Subtotal $ (380) $ — $ — Income tax provision (benefit) $ (380) $ — $ — |
Reconciliation of the statutory United States federal rate to the Company's effective tax rate | Year Ended December 31, 2023 2022 2021 Percent of pre-tax income: United States federal statutory income tax rate 21.0 % 21.0 % 21.0 % State taxes, net of federal benefit (1.2) 1.7 2.6 Foreign rate differences — — — Permanent items — (0.1) 0.2 Research and development credit 0.9 1.8 2.6 Stock-based compensation costs (3.5) (2.3) (1.2) Other 0.7 — — Change in valuation allowance (17.7) (22.1) (25.2) Effective income tax rate 0.2 % — % — % |
Components of the Company's net deferred tax assets | December 31, (in thousands) 2023 2022 Net operating loss carryforwards $ 170,402 $ 131,423 Research and development credits 65,225 63,164 Depreciation and amortization 37,211 51,877 Stock-based compensation 30,370 32,561 Sales related accruals 38,474 23,864 Other accruals 42,480 19,717 Capitalized research and development 46,062 17,673 Gross deferred tax assets 430,224 340,279 Right-of-use asset (1,538) (1,903) In-process research and development (6,403) (603) Gross deferred tax liabilities (7,941) (2,506) Total net deferred tax asset 422,283 337,773 Less valuation allowance (423,385) (337,773) Net deferred tax assets (liabilities) $ (1,102) $ — |
Reconciliation of the Company's unrecognized tax benefits | Year Ended December 31, (in thousands) 2023 2022 2021 Balance at beginning of year $ 16,838 $ 15,495 $ 13,243 Additions based on tax positions related to current year 865 1,385 2,038 Additions (reductions) for tax positions of prior years (286) (42) 214 Balance at end of year $ 17,417 $ 16,838 $ 15,495 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Net Loss Per Share | |
Schedule of Outstanding Dilutive Potential Shares Excluded from Calculation of Diluted Net loss Per Share | The following outstanding dilutive potential shares were excluded from the calculation of diluted net loss per share due to their anti-dilutive effect: Year Ended December 31, 2023 2022 2021 Stock options, including shares subject to ESPP 24,083,222 22,214,875 19,895,097 Restricted stock units 2,266,387 2,399,465 1,811,607 Shares issuable upon conversion of 2022 Convertible Notes — 1,078,632 4,473,871 Shares issuable upon conversion of 2026 Convertible Notes 11,942,152 11,942,152 11,942,152 Total 38,291,761 37,635,124 38,122,727 |
Organization and Summary of S_4
Organization and Summary of Significant Accounting Policies - Organization (Details) $ in Millions | 12 Months Ended | |
Mar. 01, 2024 USD ($) | Dec. 31, 2023 product item | |
Business Acquisition [Line Items] | ||
Product pipeline, number of product candidates | product | 3 | |
Number of reportable and operating segments | item | 1 | |
Coherus Ophthalmology LLC | CIMERLI Disposition Transaction | Subsequent Event | ||
Business Acquisition [Line Items] | ||
Business combination consideration transferred | $ 170 | |
Consideration transferred for CIMERLI product inventory and prepaid manufacturing assets | $ 17.8 |
Organization and Summary of S_5
Organization and Summary of Significant Accounting Policies - Cash, Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 |
Organization and Summary of Significant Accounting Policies | ||||
Cash and cash equivalents | $ 102,891 | $ 63,547 | $ 417,195 | $ 541,158 |
Restricted cash | 452 | 440 | 440 | 440 |
Total cash, cash equivalents and restricted cash | $ 103,343 | $ 63,987 | $ 417,635 | $ 541,598 |
Organization and Significant Ac
Organization and Significant Accounting Policies - Investments in Marketable Securities (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Organization and Summary of Significant Accounting Policies | |||
Interest income from marketable securities | $ 2,800,000 | $ 1,900,000 | $ 1,400,000 |
Impairments related to credit losses | $ 0 | $ 0 | $ 0 |
Organization and Significant _2
Organization and Significant Accounting Policies - Derivative Instruments (Details) | Dec. 31, 2023 USD ($) |
Organization and Summary of Significant Accounting Policies | |
Derivative Asset | $ 0 |
Derivative Liability | $ 0 |
Organization and Significant _3
Organization and Significant Accounting Policies - Inventory (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Inventory write-downs | $ 52,595 | $ 26,000 | $ 5,133 |
Cost of Goods Sold | |||
Inventory write-downs | 52,600 | ||
Cost of Goods Sold | YUSIMRY | |||
Inventory write-downs | $ 47,000 | ||
Cost of Goods Sold | UDENYCA | |||
Inventory write-downs | $ 26,000 |
Organization and Significant _4
Organization and Significant Accounting Policies - Property and Equipment (Details) | Dec. 31, 2023 |
Property and Equipment, Net | |
Estimated useful lives, description | us-gaap:UsefulLifeTermOfLeaseMember |
Furniture and fixtures | |
Property and Equipment, Net | |
Estimated useful lives | 5 years |
Machinery and equipment | |
Property and Equipment, Net | |
Estimated useful lives | 5 years |
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 Summary of S_6
Organization and Summary of Significant Accounting Policies -Goodwill and Intangible Assets and Impairment of Long-Lived Assets (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Goodwill and Intangible Assets and Impairment of Long-Lived Assets | ||
Long lived assets, material impairments | $ 0 | $ 0 |
In-process research and development | ||
Goodwill and Intangible Assets and Impairment of Long-Lived Assets | ||
Finite-Lived Intangible Asset, Useful Life | 10 years | |
Licensing Agreements | ||
Goodwill and Intangible Assets and Impairment of Long-Lived Assets | ||
Finite-Lived Intangible Asset, Useful Life | 15 years |
Organization and Significant _5
Organization and Significant Accounting Policies - Net Revenues (Details) | 12 Months Ended |
Dec. 31, 2023 | |
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 _6
Organization and Significant Accounting Policies - Cost of Goods Sold (Details) - USD ($) $ in Thousands | 12 Months Ended | |||||
Nov. 04, 2019 | Jul. 01, 2019 | May 02, 2019 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Cost of Goods Sold | ||||||
Royalty payment term | 5 years | |||||
Inventory write-downs, net | $ 52,595 | $ 26,000 | $ 5,133 | |||
Bioeq IP AG | ||||||
Cost of Goods Sold | ||||||
Percentage of gross profits shared | 50% | 50% | ||||
LOQTORZI | ||||||
Cost of Goods Sold | ||||||
Percentage Of royalties on net sales | 20% |
Organization and Significant _7
Organization and Significant Accounting Policies - Operating and Finance Leases (Details) | Dec. 31, 2023 |
Organization and Summary of Significant Accounting Policies | |
Term of leases | 36 months |
Organization and Significant _8
Organization and Significant Accounting Policies - Selling, General and Administrative Expense (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Organization and Summary of Significant Accounting Policies | |||
Advertising expenses | $ 10.9 | $ 10.5 | $ 8.7 |
Organization and Significant _9
Organization and Significant Accounting Policies - Reclassifications (Details) | 12 Months Ended |
Dec. 31, 2023 USD ($) | |
Organization and Summary of Significant Accounting Policies | |
Changes to net cash used in operating activities in the consolidated statements of cash flows | $ 0 |
Revenue - Net Revenue (Details)
Revenue - Net Revenue (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Revenue | |||
Net revenue | $ 257,244 | $ 211,042 | $ 326,551 |
Total net product revenue | |||
Revenue | |||
Net revenue | 256,580 | 210,760 | 326,509 |
UDENYCA | |||
Revenue | |||
Net revenue | 127,064 | 203,814 | 326,509 |
CIMERLI | |||
Revenue | |||
Net revenue | 125,388 | 6,946 | |
YUSIMRY | |||
Revenue | |||
Net revenue | 3,574 | ||
LOQTORZI | |||
Revenue | |||
Net revenue | 554 | ||
Other | |||
Revenue | |||
Net revenue | $ 664 | $ 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, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
McKesson | |||
Concentration Risk | |||
Percentage of total gross revenue | 40% | 38% | 39% |
Cencora (previously known as AmeriSource-Bergen Corporation) | |||
Concentration Risk | |||
Percentage of total gross revenue | 43% | 44% | 39% |
Cardinal | |||
Concentration Risk | |||
Percentage of total gross revenue | 15% | 17% | 20% |
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, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Accounts Notes And Loans Receivable | |||
Activities and reserve balance, beginning balance | $ 100,503 | $ 109,723 | $ 123,398 |
Provision related to sales made in: | |||
Current period | 844,325 | 578,699 | 679,199 |
Prior period - increase (decrease) | 3,807 | (3,108) | (11,407) |
Payments and customer credits issued | (703,750) | (584,811) | (681,467) |
Activities and reserve balance, ending balance | 244,885 | 100,503 | 109,723 |
Chargebacks and Discounts for Prompt Payment | |||
Accounts Notes And Loans Receivable | |||
Activities and reserve balance, beginning balance | 42,677 | 29,665 | 40,580 |
Provision related to sales made in: | |||
Current period | 590,772 | 436,865 | 470,791 |
Prior period - increase (decrease) | (1,361) | (2,090) | (2,876) |
Payments and customer credits issued | (558,135) | (421,763) | (478,830) |
Activities and reserve balance, ending balance | 73,953 | 42,677 | 29,665 |
Rebates | |||
Accounts Notes And Loans Receivable | |||
Activities and reserve balance, beginning balance | 38,713 | 54,004 | 54,058 |
Provision related to sales made in: | |||
Current period | 143,370 | 68,399 | 113,705 |
Prior period - increase (decrease) | 1,424 | (1,050) | (4,976) |
Payments and customer credits issued | (62,370) | (82,640) | (108,783) |
Activities and reserve balance, ending balance | 121,137 | 38,713 | 54,004 |
Other Fees, Co-pay Assistance and Returns | |||
Accounts Notes And Loans Receivable | |||
Activities and reserve balance, beginning balance | 19,113 | 26,054 | 28,760 |
Provision related to sales made in: | |||
Current period | 110,183 | 73,435 | 94,703 |
Prior period - increase (decrease) | 3,744 | 32 | (3,555) |
Payments and customer credits issued | (83,245) | (80,408) | (93,854) |
Activities and reserve balance, ending balance | $ 49,795 | $ 19,113 | $ 26,054 |
Fair Value Measurements - Finan
Fair Value Measurements - Financial Assets Measured on a Recurring Basis (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
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 | |
U.S. treasury securities | ||
Financial assets measured at fair value on a recurring basis | ||
Total financial assets | 68,418 | |
U.S. 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 | |
Cash equivalents | ||
Financial assets measured at fair value on a recurring basis | ||
Total financial assets | 55,060 | |
Cash equivalents | Level 1 | ||
Financial assets measured at fair value on a recurring basis | ||
Total financial assets | $ 55,060 | |
Fair Value Measurements Recurring Basis | ||
Financial assets measured at fair value on a recurring basis | ||
Total financial assets | $ 104,940 | |
Fair Value Measurements Recurring Basis | Contingent Consideration | ||
Financial assets measured at fair value on a recurring basis | ||
Contingent consideration | 4,472 | |
Fair Value Measurements Recurring Basis | Level 1 | ||
Financial assets measured at fair value on a recurring basis | ||
Total financial assets | 96,648 | |
Fair Value Measurements Recurring Basis | Level 2 | ||
Financial assets measured at fair value on a recurring basis | ||
Total financial assets | 7,667 | |
Fair Value Measurements Recurring Basis | Level 3 | ||
Financial assets measured at fair value on a recurring basis | ||
Total financial assets | 625 | |
Fair Value Measurements Recurring Basis | Level 3 | Contingent Consideration | ||
Financial assets measured at fair value on a recurring basis | ||
Contingent consideration | 4,472 | |
Fair Value Measurements Recurring Basis | U.S. government agency securities | ||
Financial assets measured at fair value on a recurring basis | ||
Total financial assets | 5,195 | |
Fair Value Measurements Recurring Basis | U.S. government agency securities | Level 1 | ||
Financial assets measured at fair value on a recurring basis | ||
Total financial assets | 5,195 | |
Fair Value Measurements Recurring Basis | U.S. treasury securities | ||
Financial assets measured at fair value on a recurring basis | ||
Total financial assets | 2,993 | |
Fair Value Measurements Recurring Basis | U.S. treasury securities | Level 1 | ||
Financial assets measured at fair value on a recurring basis | ||
Total financial assets | 2,993 | |
Fair Value Measurements Recurring Basis | Commercial paper and corporate notes | ||
Financial assets measured at fair value on a recurring basis | ||
Total financial assets | 6,669 | |
Fair Value Measurements Recurring Basis | Commercial paper and corporate notes | Level 2 | ||
Financial assets measured at fair value on a recurring basis | ||
Total financial assets | 6,669 | |
Fair Value Measurements Recurring Basis | Cash equivalents | ||
Financial assets measured at fair value on a recurring basis | ||
Total financial assets | 89,458 | |
Fair Value Measurements Recurring Basis | Cash equivalents | Level 1 | ||
Financial assets measured at fair value on a recurring basis | ||
Total financial assets | 88,460 | |
Fair Value Measurements Recurring Basis | Cash equivalents | Level 2 | ||
Financial assets measured at fair value on a recurring basis | ||
Total financial assets | 998 | |
Fair Value Measurements Recurring Basis | Prepaid financial instrument in Prepaid manufacturing | ||
Financial assets measured at fair value on a recurring basis | ||
Total financial assets | 625 | |
Fair Value Measurements Recurring Basis | Prepaid financial instrument in Prepaid manufacturing | Level 3 | ||
Financial assets measured at fair value on a recurring basis | ||
Total financial assets | $ 625 |
Fair Value Measurements - Cost,
Fair Value Measurements - Cost, Unrealized Gains or Losses, and Fair Value by Investment Type (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Cost, Unrealized Gains or Losses, and Fair Value by Investment | ||
Cost | $ 104,324 | $ 191,623 |
Unrealized Gain | 2 | 43 |
Unrealized (Loss) | (11) | (21) |
Fair Value | 104,315 | 191,645 |
Money market funds | ||
Cost, Unrealized Gains or Losses, and Fair Value by Investment | ||
Cost | 79,484 | 55,060 |
Fair Value | 79,484 | 55,060 |
U.S. government agency securities | ||
Cost, Unrealized Gains or Losses, and Fair Value by Investment | ||
Cost | 5,200 | 19,929 |
Unrealized Gain | 35 | |
Unrealized (Loss) | (5) | |
Fair Value | 5,195 | 19,964 |
U.S. treasury securities | ||
Cost, Unrealized Gains or Losses, and Fair Value by Investment | ||
Cost | 11,967 | 68,431 |
Unrealized Gain | 2 | 8 |
Unrealized (Loss) | (21) | |
Fair Value | 11,969 | 68,418 |
Commercial paper and corporate notes | ||
Cost, Unrealized Gains or Losses, and Fair Value by Investment | ||
Cost | 7,673 | 48,203 |
Unrealized (Loss) | (6) | |
Fair Value | $ 7,667 | $ 48,203 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) $ in Thousands | 4 Months Ended | 12 Months Ended | |
Dec. 31, 2023 USD ($) position | Dec. 31, 2023 USD ($) position | Dec. 31, 2022 USD ($) position | |
Fair Value Measurements | |||
Adjustment in the CVR liability | $ (900) | ||
Positions that were in unrealized loss positions | position | 9 | 9 | 13 |
Long lived assets, material impairments | $ 0 | $ 0 | |
Remaining contractual maturities of available-for-sale securities | 1 year | ||
Average maturity of investments upon acquisition | 9 months | 7 months |
Inventory - Components (Details
Inventory - Components (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Inventory | ||
Raw materials | $ 12,975 | $ 10,262 |
Work in process | 82,588 | 86,712 |
Finished goods | 34,537 | 18,077 |
Total | $ 130,100 | $ 115,051 |
Inventory - Balance Sheet Class
Inventory - Balance Sheet Classifications (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Inventory | ||
Inventory | $ 62,605 | $ 38,791 |
Inventory, non-current | 67,495 | 76,260 |
Total | $ 130,100 | $ 115,051 |
Inventory - Additional Informat
Inventory - Additional Information (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Inventory | |||
Inventory write-downs | $ 52,595,000 | $ 26,000,000 | $ 5,133,000 |
Prepayment made for manufacturing services | 23,657,000 | 17,880,000 | |
Prepayments made to a CMO for manufacturing services for UDENYCA | 12,600,000 | 13,000,000 | |
Prepayments made to a CMO For Other Research And Development Pipeline Program | 11,100,000 | 4,900,000 | |
Impairment charge within research and development expenses | 3,210,000 | ||
Research And Development Expense | 109,436,000 | 199,358,000 | 363,105,000 |
Expense relating to the discontinuation of CHS-2020 | 0 | ||
Cost of Goods Sold | |||
Inventory | |||
Inventory write-downs | 52,600,000 | ||
Certain firm purchase commitments | 20,500,000 | ||
Accrued and other current liabilities | |||
Inventory | |||
Certain firm purchase commitments, Short-term | 11,500,000 | ||
other liabilities, non-current | |||
Inventory | |||
Certain firm purchase commitments, Long-term | 9,000,000 | ||
YUSIMRY | Cost of Goods Sold | |||
Inventory | |||
Inventory write-downs | $ 47,000,000 | ||
UDENYCA | Cost of Goods Sold | |||
Inventory | |||
Inventory write-downs | $ 26,000,000 | ||
CHS-2020 | |||
Inventory | |||
Impairment charge for the write-off of prepaid manufacturing services no longer deemed to have future benefits | 3,200,000 | ||
Research And Development Expense | $ 11,200,000 |
Balance Sheet Components - Sche
Balance Sheet Components - Schedule of Property and Equipment, Net (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Property and Equipment, Net | ||
Total property and equipment | $ 25,770 | $ 28,911 |
Accumulated depreciation and amortization | (20,651) | (20,157) |
Property and equipment, net | 5,119 | 8,754 |
Machinery and equipment | ||
Property and Equipment, Net | ||
Total property and equipment | 13,124 | 12,944 |
Computer equipment and software | ||
Property and Equipment, Net | ||
Total property and equipment | 3,546 | 3,183 |
Furniture and fixtures | ||
Property and Equipment, Net | ||
Total property and equipment | 1,055 | 1,258 |
Leasehold improvements | ||
Property and Equipment, Net | ||
Total property and equipment | 5,751 | 6,198 |
Finance lease right of use assets | ||
Property and Equipment, Net | ||
Total property and equipment | $ 2,294 | 4,632 |
Construction in progress | ||
Property and Equipment, Net | ||
Total property and equipment | $ 696 |
Balance Sheet Components - Addi
Balance Sheet Components - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Balance Sheet Components | |||
Depreciation and amortization expense related to property and equipment, net | $ 3,200 | $ 3,600 | $ 3,500 |
Material impairments of property and equipment | 0 | 0 | $ 0 |
Software implementation costs | $ 3,200 | $ 3,500 |
Balance Sheet Components - Good
Balance Sheet Components - Goodwill and Intangible Assets, Net (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Finite-lived assets, net of accumulated amortization of $639 and $61, respectively | $ 41,871 | $ 2,368 | |
Accumulated amortization | 639 | 61 | |
Goodwill | 943 | 943 | |
Indefinite-lived assets - IPR&D | 28,859 | 2,620 | |
Total Goodwill and intangible assets, net | 71,673 | 5,931 | |
Finite-Lived Intangible Asset, Expected Amortization, for Each of Five Succeeding Fiscal Years | $ 3,800 | ||
Remaining life of the finite-lived assets | 11 years 4 months 24 days | ||
Impairment of intangible assets | $ 0 | 0 | $ 0 |
Impairment of goodwill | 0 | $ 0 | $ 0 |
Upfront And Milestone Payment | $ 25,000 |
Balance Sheet Components - Accr
Balance Sheet Components - Accrued and Other Current Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Balance Sheet Components | ||
Accrued commercial and research and development manufacturing | $ 23,470 | $ 21,774 |
Accrued co-development costs and milestone payments | 26,812 | 8,356 |
Accrued royalties | 42,031 | 5,015 |
Accrued other | 7,628 | 10,634 |
Lease liabilities, current | 2,145 | 4,318 |
Contingent consideration, current | 3,300 | |
Total Accrued and other current liabilities | $ 105,386 | $ 50,097 |
Balance Sheet Components - Othe
Balance Sheet Components - Other Liabilities, Non-current (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Balance Sheet Components | ||
Contingent consideration, non-current | $ 1,172 | $ 102 |
Deferred tax liability | 1,102 | |
Other | 10,287 | 3,365 |
Total Other liabilities, non-current | $ 12,561 | $ 3,467 |
Surface Acquisition (Details)
Surface Acquisition (Details) $ / shares in Units, $ in Thousands | 4 Months Ended | 12 Months Ended | ||
Sep. 08, 2023 USD ($) item $ / shares shares | Dec. 31, 2023 USD ($) | Dec. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | |
Surface Acquisition | ||||
Goodwill | $ 943 | $ 943 | $ 943 | |
Surface Oncology, Inc. | ||||
Surface Acquisition | ||||
Business Combination, Number of Shares Issued in Exchange of Each Share of Acquiree | shares | 0.1960 | |||
Share price | $ / shares | $ 5.2831 | |||
Contingent value right per share | item | 1 | |||
Contingent value rights payment period | 10 years | |||
Business combination consideration transferred | $ 64,596 | |||
Business Combination, Number of Shares Issued to Former Employees of Acquiree shares | shares | 161,100 | |||
Goodwill | $ 0 | |||
Business Combination, Number of Out Licensed Partnership Program | item | 2 | |||
Revenue of Acquiree since Acquisition Date | 0 | |||
Earnings or Loss of Acquiree since Acquisition Date | $ (5,900) | |||
Acquisition related costs | $ 5,100 | |||
Surface Oncology, Inc. | Surface GSK Agreement | ||||
Surface Acquisition | ||||
Milestone and royalty based CVR payments (as percent) | 70% | |||
Surface Oncology, Inc. | Surface Novartis Agreement | ||||
Surface Acquisition | ||||
Milestone and royalty based CVR payments (as percent) | 70% | |||
Surface Oncology, Inc. | Surface's SRF114 proprietary drug product candidate | ||||
Surface Acquisition | ||||
Upfront payment based CVR payments (as percent) | 25% | |||
Surface Oncology, Inc. | Surface's SRF388 proprietary drug product candidate | ||||
Surface Acquisition | ||||
Upfront payment based CVR payments (as percent) | 50% |
Surface Acquisition - Considera
Surface Acquisition - Consideration paid (Details) - Surface Oncology, Inc. $ / shares in Units, $ in Thousands | Sep. 08, 2023 USD ($) $ / shares shares |
Surface Acquisition | |
Coherus common stock issued | shares | 11,971,460 |
Share price (in dollars per share) | $ / shares | $ 4.89 |
Equity of combined company owned by Surface equity holders | $ 58,540 |
Contingent CVR liability | 5,290 |
Equity of combined company owned by Surface former employees (1) | 766 |
Business Combination, Consideration Transferred, Total | $ 64,596 |
Surface Acquisition - Estimated
Surface Acquisition - Estimated fair value of the net assets acquired (Details) - Surface Oncology, Inc. $ in Thousands | Sep. 08, 2023 USD ($) |
Assets Acquired | |
Cash and cash equivalents | $ 6,997 |
Investments in marketable securities | 21,791 |
Other prepaids and other assets | 5,260 |
Identifiable intangible assets | 39,769 |
Total assets | 73,817 |
Liabilities Assumed | |
Accrued and other current liabilities | 7,722 |
Deferred tax liability | 1,499 |
Total liabilities | 9,221 |
Total net assets acquired | 64,596 |
Out-licenses | |
Assets Acquired | |
Identifiable intangible assets | 13,530 |
In-process research and development | |
Assets Acquired | |
Identifiable intangible assets | $ 26,239 |
Surface Acquisition - The amoun
Surface Acquisition - The amount allocated to identifiable intangible assets (Details) - Surface Oncology, Inc. $ in Thousands | Sep. 08, 2023 USD ($) |
Surface Acquisition | |
Identifiable intangible assets | $ 39,769 |
Out-license - GSK | |
Surface Acquisition | |
Identifiable intangible assets | $ 2,506 |
Useful Lives | 15 years |
Out-license - Novartis Institutes | |
Surface Acquisition | |
Identifiable intangible assets | $ 11,024 |
Useful Lives | 15 years |
In-process research and development - casdozokitug | |
Surface Acquisition | |
Identifiable intangible assets | $ 25,899 |
In-process research and development - SRF 114 | |
Surface Acquisition | |
Identifiable intangible assets | $ 340 |
Surface Acquisition - Unaudited
Surface Acquisition - Unaudited Pro Forma Summary of Operations (Details) - Surface Oncology, Inc. - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Surface Acquisition | ||
Total revenues | $ 257,244 | $ 241,042 |
Net loss | $ (284,575) | $ (369,442) |
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 | Mar. 23, 2021 USD ($) | Feb. 01, 2021 USD ($) | Nov. 04, 2019 EUR (€) | May 02, 2019 | Mar. 31, 2022 USD ($) | Dec. 31, 2020 USD ($) | Oct. 31, 2018 USD ($) item | Jan. 31, 2016 USD ($) | Mar. 31, 2025 USD ($) | Jun. 30, 2024 USD ($) | Dec. 31, 2023 USD ($) $ / shares | Dec. 31, 2022 USD ($) | Dec. 31, 2022 EUR (€) | Dec. 31, 2021 USD ($) | Dec. 31, 2019 USD ($) | Dec. 31, 2019 EUR (€) | Apr. 14, 2020 $ / shares | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions | ||||||||||||||||||
Research and development | $ 109,436 | $ 199,358 | $ 363,105 | |||||||||||||||
Share Price | $ / shares | $ 3.33 | $ 14.82 | ||||||||||||||||
Upfront and milestone payment | $ 25,000 | |||||||||||||||||
Royalties due | 38,400 | 2,900 | ||||||||||||||||
Vaccinex License Agreement | ||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | ||||||||||||||||||
Maximum aggregate milestone payments to be made | $ 3,500 | |||||||||||||||||
Aggregate amount payable for achievement of certain regulatory milestones low single digit royalties on global net sales of any approved licensed products | $ 11,500 | |||||||||||||||||
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 | ||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | ||||||||||||||||||
Upfront and milestone payment | $ 11,100 | € 10 | ||||||||||||||||
Adimab Development and Option Agreement | ||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | ||||||||||||||||||
Minimum antibodies to be commercialized under commercialization option | item | 1 | |||||||||||||||||
Technical milestone payments obligated to pay | $ 300 | |||||||||||||||||
Period for payment of nominal research maintenance fee | 4 years | |||||||||||||||||
Maximum aggregate milestone payments to be made | $ 13,000 | |||||||||||||||||
Maximum antibodies partially exercised under commercialization option | item | 10 | |||||||||||||||||
Percentage of option fee to be paid on partial exercise of commercialization option | 65% | |||||||||||||||||
Additional payment to be made | $ 0 | |||||||||||||||||
Expiration term from the effective date without providing materials that pass quality control | 12 months | |||||||||||||||||
Term of agreement | 10 years | |||||||||||||||||
Novartis Agreement | ||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | ||||||||||||||||||
Term of agreement | 10 years | |||||||||||||||||
Potential development milestones | $ 325,000 | |||||||||||||||||
Sales milestones | $ 200,000 | |||||||||||||||||
GSK Agreement | ||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | ||||||||||||||||||
Sales milestones | $ 485,000 | |||||||||||||||||
Additional clinical milestones eligible to receive | 60,000 | |||||||||||||||||
Regulatory milestones eligible to receive | $ 155,000 | |||||||||||||||||
GSK Agreement | Surface | ||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | ||||||||||||||||||
Milestone payments earned | $ 30,000 | |||||||||||||||||
Junshi Biosciences | ||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | ||||||||||||||||||
License Agreement Fee | 35,000 | |||||||||||||||||
Research and development | 8,000 | 68,500 | $ 175,400 | |||||||||||||||
Unregistered shares | shares | 2,491,988 | |||||||||||||||||
Share Price | $ / shares | $ 20.06 | |||||||||||||||||
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 | Intangible assets, net and accrued and other current liabilities | ||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | ||||||||||||||||||
Accrued milestone payment | 25,000 | |||||||||||||||||
Junshi Biosciences | Accrued and other current liabilities | ||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | ||||||||||||||||||
Co-development, regulatory and technology transfer costs | 26,300 | 8,400 | ||||||||||||||||
Junshi Biosciences | Accounts payable | ||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | ||||||||||||||||||
Co-development, regulatory and technology transfer costs | $ 6,300 | $ 0 | ||||||||||||||||
Junshi Biosciences | Licensed Products | ||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | ||||||||||||||||||
Maximum paid amount for co-development activities (per licensed compound) | $ 25,000 | |||||||||||||||||
Junshi Biosciences | Toripalimab (LOQTORZI) | ||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | ||||||||||||||||||
Collaboration Agreement, upfront amount paid | $ 150,000 | |||||||||||||||||
Collaboration agreement, royalty on net sales, percentage | 20% | |||||||||||||||||
Collaboration agreement, Maximum aggregate one-time payments for the achievement of various regulatory and sales milestones | $ 380,000 | |||||||||||||||||
CHS-006 anti-TIGIT antibody | ||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | ||||||||||||||||||
License Agreement Fee | $ 35,000 | 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 | |||||||||||||||||
CHS-006 anti-TIGIT antibody | 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 | |||||||||||||||||
Scenario, Plan | Junshi Biosciences | Toripalimab (LOQTORZI) | Intangible assets, net and accrued and other current liabilities | ||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | ||||||||||||||||||
Upfront and milestone payment | $ 12,500 | $ 12,500 |
Debt Obligations - Summary of D
Debt Obligations - Summary of Debt Obligations (Details) - Level 2 - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
2027 Term Loans | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Principal amount | $ 250,000 | $ 250,000 |
Debt Instrument Unamortized Discount Premium And Debt Issuance Costs Net | (3,519) | (4,517) |
Net Carrying Value | 246,481 | 245,483 |
Estimated Fair Value | 246,481 | 245,483 |
1.5% Convertible Senior Subordinated Notes due 2026 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Principal amount | 230,000 | 230,000 |
Debt Instrument Unamortized Discount Premium And Debt Issuance Costs Net | (3,112) | (4,425) |
Net Carrying Value | 226,888 | 225,575 |
Estimated Fair Value | $ 150,155 | $ 157,205 |
Debt Obligations - 2027 Term Lo
Debt Obligations - 2027 Term Loan - Narrative (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||||||||
Feb. 05, 2024 USD ($) | Jan. 07, 2019 USD ($) | Mar. 31, 2022 USD ($) | Jan. 31, 2022 USD ($) | Dec. 31, 2023 USD ($) | Mar. 31, 2022 USD ($) | Dec. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | Sep. 14, 2022 USD ($) | Jan. 05, 2022 USD ($) tranche | Apr. 30, 2020 USD ($) | Jan. 01, 2020 | Feb. 29, 2016 USD ($) | |
Debt Instrument [Line Items] | |||||||||||||
Outstanding amount paid off | $ 81,750 | ||||||||||||
Outstanding amount payoff | $ 109,000 | ||||||||||||
2027 Term Loans | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Interest rate | 13.91% | ||||||||||||
2027 Term Loans | Secured Overnight Financing Rate (SOFR) Overnight Index Swap Rate [Member] | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Spread on variable rate | 1% | ||||||||||||
Interest rate | 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 | $ 246,481 | $ 246,481 | |||||||||||
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 | ||||||||||||
Mandatory prepayment term | 10 days | ||||||||||||
Debt discounts and issuance costs | $ 6,800 | ||||||||||||
Remaining unamortized debt discount and debt offering costs | $ 3,519 | $ 3,519 | |||||||||||
2027 Term Loans | BioPharma Credit Investments V GP LLC | Scenario, Plan | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Loan agreement covenants, minimum trailing twelve-month net sales continuing through the quarter ended December 31, 2026 | $ 125,000 | ||||||||||||
2027 Term Loans | BioPharma Credit Investments V GP LLC | 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 on March 31, 2022 | BioPharma Credit Investments V GP LLC | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Principal amount | $ 100,000 | $ 100,000 | |||||||||||
Debt discounts and issuance costs | 2,300 | ||||||||||||
Convertible notes, Issuance Cost | 1,000 | $ 1,000 | |||||||||||
Tranche C Loan, not 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 | $ 226,888 | $ 226,888 | |||||||||||
Stated interest rate | 1.50% | ||||||||||||
Remaining unamortized debt discount and debt offering costs | $ 3,112 | $ 3,112 | |||||||||||
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 | ||||||||||||
2025 Term Loan | Convertible Notes | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Outstanding amount paid off | 81,900 | ||||||||||||
2025 Term Loan | Lender | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Principal amount | $ 75,000 | ||||||||||||
Stated interest rate | 6.75% | ||||||||||||
Outstanding amount paid off | $ 81,900 | ||||||||||||
Total term of the loan | 6 years | ||||||||||||
Tranches A, B and D | BioPharma Credit Investments V GP LLC | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Remaining unamortized debt discount and debt offering costs | $ 3,500 | $ 3,500 | |||||||||||
Remaining term | 3 years |
Debt Obligations - 2027 Term _2
Debt Obligations - 2027 Term Loans Interest Expense Components (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Debt Instrument [Line Items] | |||
Amortization of debt discount and debt issuance costs | $ 2,407 | $ 6,431 | $ 4,257 |
2027 Term Loans | BioPharma Credit Investments V GP LLC | |||
Debt Instrument [Line Items] | |||
Contractual interest | 34,289 | 20,243 | |
Amortization of debt discount and debt issuance costs | 1,094 | 4,550 | |
Total Interest expense | $ 35,383 | $ 24,793 |
Debt Obligations - 2027 Term _3
Debt Obligations - 2027 Term Loan Future Payments (Details) - 2027 Term Loans $ in Thousands | 3 Months Ended |
Dec. 31, 2023 USD ($) | |
Debt Instrument [Line Items] | |
Interest rate | 13.91% |
BioPharma Credit Investments V GP LLC | |
Debt Instrument [Line Items] | |
2024 - interest only | $ 35,345 |
2025 - interest only | 35,248 |
2026 - principal and interest | 224,607 |
2027 - principal and interest | 50,097 |
Total minimum payments | 345,297 |
Less amount representing interest | (95,297) |
2027 Term Loans, gross | 250,000 |
Debt Instrument Unamortized Discount Premium And Debt Issuance Costs Net | (3,519) |
Net Carrying Value | $ 246,481 |
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, 2023 USD ($) item $ / shares | Apr. 14, 2020 $ / shares | |
Debt Instrument | |||
Closing stock, price per share | $ / shares | $ 3.33 | $ 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, 2023, 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 | $ 3,112,000 | ||
Effective interest rate | 2.10% | ||
Convertible Notes | 1.5% Convertible Senior Subordinated Notes due 2026 | Scenario, Plan | |||
Debt Instrument | |||
Convertible notes, converted amount | $ 39,800,000 |
Debt Obligations - Capped Call
Debt Obligations - Capped Call Transactions - Narrative (Details) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | ||
Apr. 30, 2020 | Dec. 31, 2023 | Apr. 14, 2020 | |
Option Indexed to Issuer's Equity [Line Items] | |||
Closing stock, price per share | $ 3.33 | $ 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, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Debt Instrument | |||
Amortization of debt discount and debt issuance costs | $ 2,407 | $ 6,431 | $ 4,257 |
1.5% Convertible Senior Subordinated Notes due 2026 | Convertible Notes | |||
Debt Instrument | |||
Stated coupon interest | 3,450 | 3,450 | 3,450 |
Amortization of debt discount and debt issuance costs | 1,313 | 1,286 | 1,259 |
Total Interest expense | $ 4,763 | $ 4,736 | $ 4,709 |
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, 2023 USD ($) |
Debt Instrument | |
2024 - interest only | $ 3,450 |
2025 - interest only | 3,450 |
2026 - principal and interest | 231,725 |
Total minimum payments | 238,625 |
Less amount representing interest | (8,625) |
2026 Convertible Notes, principal amount | 230,000 |
Less unamortized debt discount and debt issuance costs | (3,112) |
Net Carrying Value | $ 226,888 |
Debt Obligations - Convertibl_2
Debt Obligations - Convertible Notes due 2022 Narrative (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | |||
Feb. 29, 2016 | Mar. 31, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Debt Instrument | |||||
Outstanding amount payoff | $ 109,000 | ||||
Amortization of debt discount and debt issuance costs | $ 2,407 | 6,431 | $ 4,257 | ||
8.2% Convertible Notes due 2022 | |||||
Debt Instrument | |||||
Interest rate description | The 2022 Convertible Notes constituted general, senior unsubordinated obligations of the Company and were guaranteed by certain subsidiaries of the Company, bore interest at a fixed coupon rate of 8.2% per annum payable quarterly and matured on March 31, 2022 | ||||
Convertible Notes | KKR Member | |||||
Debt Instrument | |||||
Principal Amount | $ 20,000 | ||||
Convertible Notes | MX II Member | |||||
Debt Instrument | |||||
Principal Amount | 4,000 | ||||
Convertible Notes | KMGCP Member | |||||
Debt Instrument | |||||
Principal Amount | 1,000 | ||||
Convertible Notes | Lender | KKR Member | |||||
Debt Instrument | |||||
Principal Amount | 75,000 | ||||
Convertible Notes | 8.2% Convertible Notes due 2022 | |||||
Debt Instrument | |||||
Principal Amount | $ 100,000 | ||||
Stated interest rate | 8.20% | ||||
Outstanding amount payoff | $ 111,100 | ||||
Convertible Notes Payable | $ 0 | ||||
Convertible notes, premium percentage | 9% | ||||
Interest expense | 2,571 | 10,166 | |||
Stated coupon interest | 2,050 | 8,200 | |||
Amortization of debt discount and debt issuance costs | $ 521 | $ 1,966 |
Debt Obligations - 2025 Term Lo
Debt Obligations - 2025 Term Loan - Narrative (Details) - USD ($) $ in Thousands | 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 | |||
Loss on debt extinguishment | $ (6,222) | |||
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. | |||
Lender | 2025 Term Loan | ||||
Debt Instrument | ||||
Total term of the loan | 6 years | |||
Principal Amount | $ 75,000 | |||
Outstanding amount paid off | $ 81,900 | |||
Stated interest rate | 6.75% | |||
Prepayment premium percentage | 5% | |||
Percentage required to pay an additional exit fee on principal amount | 4% | |||
Loss on debt extinguishment | $ (6,200) |
Debt Obligations - 2025 Term _2
Debt Obligations - 2025 Term Loan Interest Expense Components (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Debt Instrument | |||
Amortization of debt discount and debt issuance costs | $ 2,407 | $ 6,431 | $ 4,257 |
Lender | 2025 Term Loan | Convertible Notes | |||
Debt Instrument | |||
Stated coupon interest | 154 | 7,034 | |
Amortization of debt discount and debt issuance costs | 16 | 1,032 | |
Total Interest expense | $ 170 | $ 8,066 |
Commitments and Contingencies -
Commitments and Contingencies - Schedule of Non-Cancelable Contractual Obligations (Details) $ in Thousands | Dec. 31, 2023 USD ($) |
Commitments and Contingencies. | |
2024 | $ 52,514 |
2025 | 19,154 |
2026 | 1,410 |
Total obligations | $ 73,078 |
Commitments and Contingencies_2
Commitments and Contingencies - Additional Information (Details) - USD ($) $ in Millions | 1 Months Ended | ||
Apr. 30, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | |
Loss Contingencies | |||
Claims related to certain sales of UDENYCA from October 2020 through December 2021 | $ 14 | ||
Accrued rebates, fees and reserves | |||
Loss Contingencies | |||
Accrual related to legal Proceedings and Other Claims | $ 6.4 | $ 4.7 |
Leases - Additional Information
Leases - Additional Information (Details) | 12 Months Ended | ||||
Dec. 31, 2023 ft² | Dec. 31, 2019 item | Oct. 24, 2023 ft² | Dec. 31, 2022 | Dec. 31, 2021 | |
Lessee Lease Description | |||||
Term of leases | 36 months | ||||
Operating lease Weighted average discount rate | 11.80% | 8% | 8% | ||
Finance lease weighted average remaining term | 1 year 4 months 24 days | 2 years 2 months 12 days | 1 year 8 months 12 days | ||
Sixth amendment to lease | |||||
Lessee Lease Description | |||||
Area of land | 20,257 | ||||
Remaining Premises | Sixth amendment to lease | |||||
Lessee Lease Description | |||||
Area of land | 27,532 | ||||
Corporate Headquarters Lease | |||||
Lessee Lease Description | |||||
Area of office space leased | 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 | 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 | 50 | ||||
Term of leases | 36 months |
Leases - Schedule of Balance Sh
Leases - Schedule of Balance Sheet Classification of Lease Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Assets: | ||
Operating leases | $ 5,912 | $ 5,690 |
Operating Lease, Right-of-Use Asset, Statement of Financial Position [Extensible List] | Other Assets Noncurrent | Other Assets Noncurrent |
Finance lease | $ 1,022 | $ 2,584 |
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 | $ 6,934 | $ 8,274 |
Liabilities: | ||
Operating lease liabilities, current | $ 1,424 | $ 3,127 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | Accrued Liabilities Current | Accrued Liabilities Current |
Operating lease liability noncurrent | $ 4,977 | $ 3,628 |
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 | $ 6,401 | $ 6,755 |
Finance lease liabilities, current | $ 721 | $ 1,191 |
Finance Lease, Liability, Current, Statement of Financial Position [Extensible List] | Accrued Liabilities Current | Accrued Liabilities Current |
Finance lease liabilities, non-current | $ 351 | $ 1,418 |
Finance Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | Other Liabilities Noncurrent | Other Liabilities Noncurrent |
Total finance lease liabilities | $ 1,072 | $ 2,609 |
Leases - Other information rela
Leases - Other information related to lease term and discount rate (Details) | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Leases | |||
Operating lease weighted average remaining term | 3 years 7 months 6 days | 2 years 2 months 12 days | 3 years 2 months 12 days |
Finance lease weighted average remaining term | 1 year 4 months 24 days | 2 years 2 months 12 days | 1 year 8 months 12 days |
Operating lease Weighted average discount rate | 11.80% | 8% | 8% |
Finance lease Weighted average discount rate | 8.70% | 8.40% | 5.80% |
Leases - Components of lease ex
Leases - Components of lease expense (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Leases | |||
Amortization of right-of-use assets | $ 1,069 | $ 1,228 | $ 707 |
Interest on lease liabilities | 146 | 166 | 82 |
Total finance lease cost | 1,215 | 1,394 | 789 |
Operating lease cost | 2,984 | 3,154 | 3,066 |
Total lease cost | $ 4,199 | $ 4,548 | $ 3,855 |
Leases - Supplemental cash flow
Leases - Supplemental cash flow information related to leases (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Leases | |||
Operating cash flows from operating leases | $ 3,560 | $ 3,401 | $ 3,435 |
Operating cash flows from finance leases | 145 | 155 | 81 |
Financing cash flows from finance leases | 1,034 | 1,228 | 672 |
Operating leases | $ 2,653 | 434 | |
Finance leases | $ 2,694 | $ 477 |
Leases - Schedule of Maturities
Leases - Schedule of Maturities of Operating and Finance Lease Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Operating leases | ||
2024 | $ 2,095 | |
2025 | 2,192 | |
2026 | 2,126 | |
2027 | 1,531 | |
Total lease payments | 7,944 | |
Less imputed interest | (1,543) | |
Total operating lease liabilities | 6,401 | $ 6,755 |
Finance leases | ||
2024 | 781 | |
2025 | 358 | |
Total lease payments | 1,139 | |
Less imputed interest | (67) | |
Total finance lease liabilities | $ 1,072 | $ 2,609 |
Stockholders' Deficit (Details)
Stockholders' Deficit (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |||||||||
Oct. 09, 2023 | Oct. 04, 2023 | Sep. 11, 2023 | May 18, 2023 | May 16, 2023 | Nov. 08, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | May 15, 2023 | |
Stockholders' Deficit | ||||||||||
Common stock, par value | $ 0.0001 | $ 0.0001 | ||||||||
Aggregate offering price | $ 40,903 | |||||||||
CMO | Optional Stock Purchase Agreement | ||||||||||
Stockholders' Deficit | ||||||||||
Common stock, shares issued and sold | 2,225,513 | |||||||||
Aggregate offering price | $ 8,200 | |||||||||
Number of trading days considered for price per share of common stock | 10 days | |||||||||
Share price | $ 3.675 | |||||||||
Public Offering | ||||||||||
Stockholders' Deficit | ||||||||||
Common stock, shares issued and sold | 13,529,411 | |||||||||
Aggregate offering price | $ 53,625 | |||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 53,600 | $ 53,625 | ||||||||
Share price | $ 4.25 | |||||||||
Public Offering | Maximum | ||||||||||
Stockholders' Deficit | ||||||||||
Shares Offering, Aggregate Amount | $ 150,000 | |||||||||
At The Market Offering. | ||||||||||
Stockholders' Deficit | ||||||||||
Common stock, shares issued and sold | 3,559,761 | 916,884 | ||||||||
Aggregate offering price | $ 18,317 | |||||||||
Proceeds from issuance of common stock, net of issuance costs | 18,093 | $ 6,358 | ||||||||
Shares Offering, Aggregate Amount, Decrease | $ 86,250 | |||||||||
Increase in Amount of Shares To be Issued and Sold | $ 28,750 | |||||||||
Common stock, net proceeds | 18,856 | 6,524 | ||||||||
Gross proceeds | 19,339 | 6,692 | ||||||||
Less commissions and fees | (483) | (168) | ||||||||
Net proceeds after commissions and fees | 18,856 | $ 6,524 | ||||||||
Common stock remaining available for sales under the ATM Offering | $ 66,500 | |||||||||
At The Market Offering. | Weighted Average | ||||||||||
Stockholders' Deficit | ||||||||||
Weighted-average price per share | $ 5.43 | $ 7.30 | ||||||||
At The Market Offering. | Maximum | ||||||||||
Stockholders' Deficit | ||||||||||
Aggregate offering price | $ 150,000 | |||||||||
Shares Offering, Aggregate Amount | $ 92,500 | $ 150,000 | $ 63,750 | |||||||
Underwriters' Option to Purchase Additional Shares | ||||||||||
Stockholders' Deficit | ||||||||||
Share price | $ 3.995 | |||||||||
Term of share offering | 30 days |
Stock-Based Compensation and _3
Stock-Based Compensation and Employee Benefits - Equity Incentive Plans Narrative (Details) | 12 Months Ended | 120 Months Ended |
Dec. 31, 2023 shares | Dec. 31, 2023 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 | 881,231 | 881,231 |
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 | 1,773,921 | 1,773,921 |
Stock-Based Compensation and _4
Stock-Based Compensation and Employee Benefits - Stock Options Narrative (Details) $ in Millions | 12 Months Ended |
Dec. 31, 2023 USD ($) | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Unrecognized stock-based compensation expenses related to stock options | $ 37.4 |
Unrecognized share-based compensation related to stock options, RSUs and ESPP, period for recognition | 2 years 3 months 18 days |
Employee Stock Option | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Vesting period | 4 years |
Options, expiration period | 10 years |
Stock-Based Compensation and _5
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, 2023 USD ($) $ / shares shares | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Number of Options, Beginning balance | shares | 21,691,321 |
Number of Options, Granted - at fair value | shares | 5,947,607 |
Number of Options, Exercised | shares | (430,504) |
Number of Options, Forfeited/Canceled | shares | (3,549,184) |
Number of Options, Ending balance | shares | 23,659,240 |
Number of Options, Exercisable | shares | 16,279,679 |
Weighted-Average Exercise Price, Beginning balance | $ / shares | $ 15 |
Weighted-Average Exercise Price, Granted - at fair value | $ / shares | 6.86 |
Weighted Average Exercise Price, Exercised | $ / shares | 1.61 |
Weighted Average Exercise Price, Forfeited/Canceled | $ / shares | 14.25 |
Weighted-Average Exercise Price, Ending balance | $ / shares | 13.31 |
Weighted Average Exercise Price, Exercisable | $ / shares | $ 15.20 |
Options outstanding, Weighted-Average Remaining Contractual Terms | 5 years 8 months 12 days |
Options outstanding, Weighted-Average Remaining Contractual Terms, Exercisable | 4 years 3 months 18 days |
Options outstanding, Aggregate Intrinsic Value | $ | $ 2,337 |
Options outstanding, Aggregate Intrinsic Value, Exercisable | $ | $ 1,815 |
Stock-Based Compensation and _6
Stock-Based Compensation and Employee Benefits - Options outstanding and exercisable (Details) - 2016 plan and 2014 plan - $ / shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Options outstanding, Number of Options | 23,659,240 | 21,691,321 |
Options outstanding, Weighted-Average Remaining Contractual Terms | 5 years 8 months 12 days | |
Options outstanding, Weighted-Average Exercise Price | $ 13.31 | $ 15 |
Number of Options, Exercisable | 16,279,679 | |
Weighted Average Exercise Price, Exercisable | $ 15.20 | |
1.67 - 5.44 | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Exercise price range, Lower | 1.67 | |
Exercise price range, Upper | $ 5.44 | |
Options outstanding, Number of Options | 4,288,840 | |
Options outstanding, Weighted-Average Remaining Contractual Terms | 6 years 10 months 24 days | |
Options outstanding, Weighted-Average Exercise Price | $ 3.92 | |
Number of Options, Exercisable | 1,356,589 | |
Weighted Average Exercise Price, Exercisable | $ 2.32 | |
5.86 - 10.05 | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Exercise price range, Lower | 5.86 | |
Exercise price range, Upper | $ 10.05 | |
Options outstanding, Number of Options | 4,493,996 | |
Options outstanding, Weighted-Average Remaining Contractual Terms | 6 years 6 months | |
Options outstanding, Weighted-Average Exercise Price | $ 9.20 | |
Number of Options, Exercisable | 2,436,570 | |
Weighted Average Exercise Price, Exercisable | $ 9.45 | |
10.37 - 13.63 | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Exercise price range, Lower | 10.37 | |
Exercise price range, Upper | $ 13.63 | |
Options outstanding, Number of Options | 4,143,765 | |
Options outstanding, Weighted-Average Remaining Contractual Terms | 5 years 7 months 6 days | |
Options outstanding, Weighted-Average Exercise Price | $ 12.41 | |
Number of Options, Exercisable | 3,317,635 | |
Weighted Average Exercise Price, Exercisable | $ 12.53 | |
14.03 - 17.17 | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Exercise price range, Lower | 14.03 | |
Exercise price range, Upper | $ 17.17 | |
Options outstanding, Number of Options | 4,436,113 | |
Options outstanding, Weighted-Average Remaining Contractual Terms | 5 years 9 months 18 days | |
Options outstanding, Weighted-Average Exercise Price | $ 15.82 | |
Number of Options, Exercisable | 3,304,217 | |
Weighted Average Exercise Price, Exercisable | $ 15.86 | |
17.30 - 19.40 | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Exercise price range, Lower | 17.30 | |
Exercise price range, Upper | $ 19.40 | |
Options outstanding, Number of Options | 3,827,172 | |
Options outstanding, Weighted-Average Remaining Contractual Terms | 5 years 6 months | |
Options outstanding, Weighted-Average Exercise Price | $ 17.96 | |
Number of Options, Exercisable | 3,403,068 | |
Weighted Average Exercise Price, Exercisable | $ 17.95 | |
19.85 - 46.38 | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Exercise price range, Lower | 19.85 | |
Exercise price range, Upper | $ 46.38 | |
Options outstanding, Number of Options | 2,469,354 | |
Options outstanding, Weighted-Average Remaining Contractual Terms | 2 years 1 month 6 days | |
Options outstanding, Weighted-Average Exercise Price | $ 26.90 | |
Number of Options, Exercisable | 2,461,600 | |
Weighted Average Exercise Price, Exercisable | $ 26.91 |
Stock-Based Compensation and _7
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, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Total intrinsic value of options exercised | $ 425 | $ 914 | $ 9,726 |
Total grant date fair value of options vested | $ 30,467 | $ 34,916 | $ 40,365 |
Weighted-average grant date fair value of options granted | $ 4.19 | $ 7.04 | $ 9.80 |
Stock-Based Compensation and _8
Stock-Based Compensation and Employee Benefits - Restricted Stock Units - narrative (Details) $ in Millions | 12 Months Ended |
Dec. 31, 2023 USD ($) | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Unrecognized share-based compensation related to stock options, RSUs and ESPP, period for recognition | 2 years 3 months 18 days |
Restricted stock units | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Unrecognized stock-based compensation expenses related to unvested RSUs | $ 10.8 |
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 _9
Stock-Based Compensation and Employee Benefits - Summary of RSUs Activity, under 2014 Plan (Details) - Restricted stock units - $ / shares | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Number of RSUs, beginning balances | 2,333,307 | ||
Number of RSUs granted | 1,274,753 | ||
Number of RSUs vested | (1,280,901) | ||
Number of RSUs canceled | (600,430) | ||
Number of RSUs, ending balance | 1,726,729 | 2,333,307 | |
Weighted-Average Grant Date Fair Value, beginning balances | $ 14.66 | ||
Weighted-Average Grant Date Fair Value, RSUs granted | 8.93 | $ 13.34 | $ 16.86 |
Weighted-Average Grant Date Fair Value, RSUs Vested | 14.35 | ||
Weighted-Average Grant Date Fair Value, RSUs canceled | 11.02 | ||
Weighted-Average Grant Date Fair Value, ending balances | $ 11.93 | $ 14.66 |
Stock-Based Compensation and_10
Stock-Based Compensation and Employee Benefits - Restricted Stock Units - Additional Information (Details) - Restricted stock units - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Total grant date fair value of RSUs vested | $ 18,381 | $ 13,598 | $ 8,434 |
Total grant date fair value of RSUs granted | $ 11,386 | $ 22,502 | $ 27,869 |
Weighted-Average Grant Date Fair Value, RSUs granted | $ 8.93 | $ 13.34 | $ 16.86 |
Stock-Based Compensation and_11
Stock-Based Compensation and Employee Benefits - Employee Stock Purchase Plan (Details) - USD ($) $ in Millions | 12 Months Ended | |
Oct. 31, 2014 | Dec. 31, 2023 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Unrecognized stock-based compensation expenses related to stock options | $ 37.4 | |
Unrecognized share-based compensation related to stock options, RSUs and ESPP, period for recognition | 2 years 3 months 18 days | |
2014 Employee Stock Purchase Plan (ESPP) | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Common stock reserved for future issuance | 2,541,769 | |
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 | $ 0.4 | |
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_12
Stock-Based Compensation and Employee Benefits - Stock-Based Expense (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Feb. 28, 2021 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs | ||||
Stock-based compensation expense | $ 800 | $ 43,110 | $ 50,737 | $ 51,364 |
Stock-based compensation expense capitalized into inventory | 1,062 | 1,187 | 1,025 | |
Cost of Goods Sold | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs | ||||
Stock-based compensation expense | 632 | 736 | 1,099 | |
Research and development | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs | ||||
Stock-based compensation expense | 14,596 | 18,999 | 18,688 | |
Selling, General and Administrative Expenses | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs | ||||
Stock-based compensation expense | $ 27,882 | $ 31,002 | $ 31,577 |
Stock-Based Compensation and_13
Stock-Based Compensation and Employee Benefits - Additional Information (Details) - Employee Severance [Member] - USD ($) $ in Millions | 3 Months Ended | 12 Months Ended |
Mar. 31, 2023 | Dec. 31, 2023 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Stock-based compensation includes restructuring charges | $ 1.5 | |
Forfeiture credit | $ 0.5 | |
Research and development | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Stock-based compensation includes restructuring charges | $ 1.1 | |
Selling, General and Administrative Expenses | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Forfeiture credit | $ 0.1 |
Stock-Based Compensation and_14
Stock-Based Compensation and Employee Benefits - Valuation Assumptions (Details) | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
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 | 105% | 70% | 42% |
Risk-free interest rate | 5.35% | 3.77% | 0.06% |
Employee Stock Option | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Expected term (years) | 6 years | 6 years 1 month 6 days | 6 years 1 month 6 days |
Expected volatility | 64% | 62% | 65% |
Risk-free interest rate | 3.92% | 2.37% | 0.89% |
Stock-Based Compensation and_15
Stock-Based Compensation and Employee Benefits - 401(k) Retirement Plan (Details) - 401(k) Plan - USD ($) | 12 Months Ended | |||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2019 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Percentage of maximum contribution of annual compensation | 100% | |||
First amount of each participant's contributions | $ 7,500 | |||
Compensation expense related to match plan | $ 1,800,000 | $ 2,100,000 | $ 1,700,000 | |
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 - Components of Lo
Income Taxes - Components of Loss Before Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Income Taxes | |||
Domestic | $ (238,272) | $ (291,746) | $ (287,058) |
Foreign | (8) | (42) | |
Loss before income taxes | $ (238,272) | $ (291,754) | $ (287,100) |
Income Taxes - Income Tax Provi
Income Taxes - Income Tax Provision (Benefit) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Deferred | |||
Federal | $ (380) | ||
Subtotal | (380) | ||
Income tax provision (benefit) | $ (380) | $ 0 | $ 0 |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Statutory U.S. Federal Rate to The Company's Effective Tax Rate (Details) | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Percent of pre-tax income: | |||
United States federal statutory income tax rate | 21% | 21% | 21% |
State taxes, net of federal benefit | (1.20%) | 1.70% | 2.60% |
Permanent items | (0.10%) | 0.20% | |
Research and development credit | 0.90% | 1.80% | 2.60% |
Stock based compensation costs | (3.50%) | (2.30%) | (1.20%) |
Other | 0.70% | ||
Change in valuation allowance | (17.70%) | (22.10%) | (25.20%) |
Effective income tax rate | 0.20% |
Income Taxes - Components of Ne
Income Taxes - Components of Net Deferred Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Components of Deferred Tax Assets [Abstract] | ||
Net operating loss carryforwards | $ 170,402 | $ 131,423 |
Research and development credits | 65,225 | 63,164 |
Depreciation and amortization | 37,211 | 51,877 |
Stock-based compensation | 30,370 | 32,561 |
Sales related accruals | 38,474 | 23,864 |
Other accruals | 42,480 | 19,717 |
Capitalized research and development | 46,062 | 17,673 |
Gross deferred tax assets | 430,224 | 340,279 |
Right-of-use asset | (1,538) | (1,903) |
In-process research and development | (6,403) | (603) |
Gross deferred tax liabilities | (7,941) | (2,506) |
Total net deferred tax asset | 422,283 | 337,773 |
Less valuation allowance | (423,385) | $ (337,773) |
Net deferred tax liabilities | $ (1,102) |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Operating Loss Carryforwards [Line Items] | ||||
Increase in valuation allowance | $ 85,600 | $ 64,400 | $ 72,400 | |
Unrecognized tax benefits | 17,417 | 16,838 | 15,495 | $ 13,243 |
Unrecognized tax benefits, accrued interest and penalties accrued | 0 | $ 0 | $ 0 | |
Federal | ||||
Operating Loss Carryforwards [Line Items] | ||||
Net operating loss carryforwards | $ 774,900 | |||
Net operating loss carryforwards expiration year | 2036 | |||
Various states | ||||
Operating Loss Carryforwards [Line Items] | ||||
Net operating loss carryforwards | $ 128,000 | |||
Net operating loss carryforwards expiration year | 2031 | |||
Federal research and development | Federal | ||||
Operating Loss Carryforwards [Line Items] | ||||
Tax credit carryforwards | $ 60,600 | |||
Tax credit carryforwards expiration year | 2031 | |||
Federal research and development | Various states | ||||
Operating Loss Carryforwards [Line Items] | ||||
Tax credit carryforwards | $ 26,500 |
Income Taxes - Reconciliation_2
Income Taxes - Reconciliation of Unrecognized Tax Benefits (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Income Taxes | |||
Balance at beginning of year | $ 16,838 | $ 15,495 | $ 13,243 |
Additions based on tax positions related to current year | 865 | 1,385 | 2,038 |
Additions for tax positions of prior years | 214 | ||
Reductions for tax positions of prior years | (286) | (42) | |
Balance at end of year | $ 17,417 | $ 16,838 | $ 15,495 |
Net Loss Per Share - Outstandin
Net Loss Per Share - Outstanding Dilutive Potential Shares Excluded from Calculation of Diluted Net loss Per Share (Details) - shares | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Antidilutive securities excluded from computation of EPS | |||
Antidilutive securities excluded from the calculation of diluted net (loss) income per share | 38,291,761 | 37,635,124 | 38,122,727 |
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 | 24,083,222 | 22,214,875 | 19,895,097 |
Restricted stock units | |||
Antidilutive securities excluded from computation of EPS | |||
Antidilutive securities excluded from the calculation of diluted net (loss) income per share | 2,266,387 | 2,399,465 | 1,811,607 |
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 | |
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 | 11,942,152 |
Restructuring Charges (Details)
Restructuring Charges (Details) - Employee Severance $ in Millions | 3 Months Ended | 12 Months Ended | |
Mar. 10, 2023 employee | Mar. 31, 2023 USD ($) | Dec. 31, 2023 USD ($) | |
Restructuring Cost And Reserve [Line Items] | |||
Employees impacted | employee | 50 | ||
Restructuring Charges | $ 3.9 | ||
Stock-based compensation includes restructuring charges | 1.5 | ||
Forfeiture credit | $ 0.5 | ||
Research and Development Expense | |||
Restructuring Cost And Reserve [Line Items] | |||
Restructuring Charges | $ 3.6 | ||
Stock-based compensation includes restructuring charges | 1.1 | ||
Selling, general and administrative expenses | |||
Restructuring Cost And Reserve [Line Items] | |||
Restructuring Charges | 1.3 | ||
Forfeiture credit | $ 0.1 |
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, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Related Party Transaction | ||||
Selling, general and administrative | $ 192,015 | $ 198,481 | $ 169,713 | |
Stock-based compensation expense | $ 800 | $ 43,110 | $ 50,737 | 51,364 |
Consulting Agreement With Lanfear Advisors | ||||
Related Party Transaction | ||||
Number of options, granted | 65,000 | |||
Exercise price | $ 17.60 | |||
Consulting expense | $ 200 |
Subsequent Events (Details)
Subsequent Events (Details) - Subsequent Event - USD ($) $ in Millions | Apr. 01, 2024 | Mar. 01, 2024 | Feb. 05, 2024 |
2027 Term Loans | |||
Subsequent Events | |||
Partial prepayment of principal | $ 175 | $ 175 | |
Principal Amount | 250 | ||
Prepayment fees for partial debt repayment | $ 6.8 | ||
Coherus Ophthalmology LLC | CIMERLI Disposition Transaction | |||
Subsequent Events | |||
Business combination consideration transferred | $ 170 | ||
Consideration transferred for CIMERLI product inventory and prepaid manufacturing assets | $ 17.8 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Pay vs Performance Disclosure | |||
Net Income (Loss) | $ (237,892) | $ (291,754) | $ (287,100) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Dec. 31, 2023 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |