Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2024 | Apr. 30, 2024 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Period End Date | Mar. 31, 2024 | |
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, $0.0001 par value per share | |
Trading Symbol | CHRS | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 114,725,740 | |
Entity Central Index Key | 0001512762 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2024 | |
Document Fiscal Period Focus | Q1 | |
Amendment Flag | false | |
Document Quarterly Report | true |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Current assets: | ||
Cash and cash equivalents | $ 259,775 | $ 102,891 |
Investments in marketable securities | 14,857 | |
Trade receivables, net | 251,951 | 260,522 |
TSA receivables, net (Note 6) | 32,194 | |
Inventory | 61,978 | 62,605 |
Prepaid manufacturing | 7,498 | 23,657 |
Other prepaids and current assets | 14,081 | 11,099 |
Total current assets | 627,477 | 475,631 |
Property and equipment, net | 4,188 | 5,119 |
Inventory, non-current | 65,645 | 67,495 |
Intangible assets, net | 57,104 | 71,673 |
Other assets, non-current | 9,131 | 9,686 |
Total assets | 763,545 | 629,604 |
Current liabilities: | ||
Accounts payable | 38,289 | 35,219 |
Accrued rebates, fees and reserves | 155,775 | 169,645 |
TSA payables and other accrued liabilities (Note 6) | 30,770 | |
Accrued compensation | 22,762 | 21,521 |
Accrued and other current liabilities | 115,707 | 105,386 |
Term loans, current | 175,000 | |
Total current liabilities | 538,303 | 331,771 |
Term loans, non-current | 72,452 | 246,481 |
Convertible notes | 227,220 | 226,888 |
Lease liabilities, non-current | 4,680 | 5,328 |
Other liabilities, non-current | 2,734 | 12,561 |
Total liabilities | 845,389 | 823,029 |
Commitments and contingencies (Note 9) | ||
Stockholders' deficit: | ||
Common stock ($0.0001 par value; shares authorized: 300,000,000; shares issued and outstanding: 113,496,854 and 112,215,260 at March 31, 2024 and December 31, 2023, respectively) | 11 | 11 |
Additional paid-in capital | 1,395,042 | 1,386,312 |
Accumulated other comprehensive loss | (272) | (248) |
Accumulated deficit | (1,476,625) | (1,579,500) |
Total stockholders' deficit | (81,844) | (193,425) |
Total liabilities and stockholders' deficit | $ 763,545 | $ 629,604 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parentheticals) - $ / shares | Mar. 31, 2024 | Dec. 31, 2023 |
Statement of Financial Position [Abstract] | ||
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 | 113,496,854 | 112,215,260 |
Common stock, shares outstanding | 113,496,854 | 112,215,260 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Revenue: | ||
Net revenue | $ 77,063 | $ 32,436 |
Costs and expenses: | ||
Cost of goods sold | 34,586 | 16,874 |
Research and development | 28,470 | 34,154 |
Selling, general and administrative | 56,532 | 49,153 |
Total costs and expenses | 119,588 | 100,181 |
Loss from operations | (42,525) | (67,745) |
Interest expense | (11,116) | (9,712) |
Gain on Sale Transaction, net (Note 6) | 153,647 | |
Other income (expense), net | 2,869 | 1,728 |
Income (loss) before income taxes | 102,875 | (75,729) |
Net income (loss) | $ 102,875 | $ (75,729) |
Net Income (Loss) Per Share | ||
Basic (In dollar per share) | $ 0.91 | $ (0.96) |
Diluted (In dollar per share) | $ 0.83 | $ (0.96) |
Weighted-average number of shares used in computing net income (loss) per share: | ||
Basic (In shares) | 112,749,306 | 79,268,853 |
Diluted (In shares) | 125,529,971 | 79,268,853 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Income (Loss) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Statement of Comprehensive Income [Abstract] | ||
Net income (loss) | $ 102,875 | $ (75,729) |
Other comprehensive income (loss): | ||
Unrealized loss on available-for-sale securities, net of tax | (24) | (29) |
Comprehensive income (loss) | $ 102,851 | $ (75,758) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders' Equity (Deficit) - USD ($) $ in Thousands | Common Stock At The Market Offering. | Common Stock | Additional Paid-In Capital At The Market Offering. | Additional Paid-In Capital | Accumulated Other Comprehensive Loss | Accumulated Deficit | At The Market Offering. | Total |
Beginning Balances at Dec. 31, 2022 | $ 8 | $ 1,204,431 | $ (249) | $ (1,341,608) | $ (137,418) | |||
Beginning Balances (in shares) at Dec. 31, 2022 | 78,851,516 | |||||||
Net loss | (75,729) | (75,729) | ||||||
Issuance of common stock upon exercise of stock options | 103 | 103 | ||||||
Issuance of common stock upon exercise of stock options (in shares) | 24,107 | |||||||
Issuance of common stock upon vesting of restricted stock units ("RSUs") (in shares) | 771,167 | |||||||
Stock-based compensation expense | 12,288 | 12,288 | ||||||
Issuance of common stock under Offering, net of issuance costs | $ 7,059 | $ 7,059 | ||||||
Issuance of common stock under Offering, net of issuance costs (in shares) | 1,131,450 | 1,131,450 | ||||||
Taxes paid related to net share settlement of RSUs | (2,781) | (2,781) | ||||||
Taxes paid related to net share settlement of RSUs (in shares) | (289,944) | |||||||
Other comprehensive gain (loss), net of tax | (29) | (29) | ||||||
Ending Balances at Mar. 31, 2023 | $ 8 | 1,221,100 | (278) | (1,417,337) | (196,507) | |||
Ending Balances (in shares) at Mar. 31, 2023 | 80,488,296 | |||||||
Beginning Balances at Dec. 31, 2023 | $ 11 | 1,386,312 | (248) | (1,579,500) | $ (193,425) | |||
Beginning Balances (in shares) at Dec. 31, 2023 | 112,215,260 | 112,215,260 | ||||||
Net loss | 102,875 | $ 102,875 | ||||||
Issuance of common stock upon exercise of stock options | 291 | 291 | ||||||
Issuance of common stock upon exercise of stock options (in shares) | 174,651 | |||||||
Issuance of common stock upon vesting of restricted stock units ("RSUs") (in shares) | 741,213 | |||||||
Stock-based compensation expense | 7,677 | 7,677 | ||||||
Issuance of common stock under Offering, net of issuance costs | $ 1,507 | $ 1,507 | ||||||
Issuance of common stock under Offering, net of issuance costs (in shares) | 650,005 | 650,005 | ||||||
Taxes paid related to net share settlement of RSUs | (745) | (745) | ||||||
Taxes paid related to net share settlement of RSUs (in shares) | (284,275) | |||||||
Other comprehensive gain (loss), net of tax | (24) | (24) | ||||||
Ending Balances at Mar. 31, 2024 | $ 11 | $ 1,395,042 | $ (272) | $ (1,476,625) | $ (81,844) | |||
Ending Balances (in shares) at Mar. 31, 2024 | 113,496,854 | 113,496,854 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Operating activities | ||
Net income (loss) | $ 102,875 | $ (75,729) |
Adjustments to reconcile net income (loss) to net cash used in operating activities: | ||
Depreciation and amortization | 1,507 | 949 |
Stock-based compensation expense | 7,319 | 12,282 |
Impairment of out-license asset and remeasurement of CVR liability, net | 6,772 | |
Gain on Sale Transaction, net (Note 6) | (153,647) | |
Inventory write-downs, net | 2,481 | 3,241 |
Other non-cash adjustments, net | (2,695) | (129) |
Changes in operating assets and liabilities: | ||
Trade receivables, net | 8,579 | 8,529 |
Inventory | (11,455) | (2,671) |
Prepaid manufacturing | 9,589 | 1,861 |
Other prepaid, current and non-current assets | (4,426) | 2,057 |
Accounts payable | 616 | 11,739 |
Accrued rebates, fees and reserves | (15,157) | 1,236 |
TSA related operating assets and liabilities, net (Note 6) | (1,424) | |
Accrued compensation | 1,559 | (10,188) |
Accrued and other current and non-current liabilities | 741 | (21,909) |
Net cash used in operating activities | (46,766) | (68,732) |
Investing activities | ||
Proceeds from maturities of investments in marketable securities | 6,200 | 17,500 |
Proceeds from sale of investments in marketable securities | 8,688 | |
Cash received from Sale Transaction (Note 6) | 187,823 | |
Other investing activities, net | 52 | 26 |
Net cash provided by investing activities | 202,763 | 17,526 |
Financing activities | ||
Proceeds from issuance of common stock upon exercise of stock options | 291 | 103 |
Taxes paid related to net share settlement | (745) | (2,781) |
Other financing activities | (166) | (353) |
Net cash provided by financing activities | 887 | 3,804 |
Net increase (decrease) in cash, cash equivalents and restricted cash | 156,884 | (47,402) |
Cash, cash equivalents and restricted cash at beginning of period | 103,343 | 63,987 |
Cash, cash equivalents and restricted cash at end of period | 260,227 | 16,585 |
At The Market Offering. | ||
Financing activities | ||
Proceeds from issuance of common stock under ATM Offering, net of issuance costs | $ 1,507 | $ 6,835 |
Organization and Summary of Sig
Organization and Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2024 | |
Organization and Summary of Significant Accounting Policies | |
Organization and Summary of Significant Accounting Policies | Coherus BioSciences, Inc. Notes to Condensed Consolidated Financial Statements (unaudited) 1. Organization and Summary of Significant Accounting Policies Organization Coherus BioSciences, Inc. (the “Company” or “Coherus”) is a commercial-stage biopharmaceutical company focused on the research, development and commercialization of innovative immunotherapies to treat cancer. The Company is developing an innovative immuno-oncology pipeline that we believe will be synergistic with its proven commercial capabilities in oncology. 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), On January 2, 2024, the Company announced the launch in the U.S. of LOQTORZI in LOQTORZI is a novel PD-1 inhibitor that the Company developed in collaboration with . On January 19, 2024, the Company entered into a Purchase and Sale Agreement (the “Purchase Agreement”) with Sandoz Inc. (“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 of its CIMERLI ophthalmology franchise through the sale of its subsidiary, Coherus Ophthalmology LLC (“Coherus Ophthalmology”), 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 (“Sale Transaction”). 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 interleukin 27 (“IL-27”); and CHS-114 (formerly SRF114), a highly specific afucosylated immunoglobulin isotype G1 (“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 for Biomedical Research, Inc. (“Novartis Institutes”) and GlaxoSmithKline Intellectual Property No. 4 Limited (“GSK”), respectively. The exclusive license of NZV930 to Novartis Institutes was terminated by Novartis Institutes with an effective date of October 2, 2024. Basis of Consolidation The accompanying unaudited condensed consolidated financial statements include the accounts of Coherus and its wholly-owned subsidiaries. All intercompany transactions and balances have been eliminated upon consolidation. The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with United States generally accepted accounting principles (“U.S. GAAP”) for interim financial information and in accordance with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X of the Securities Act of 1933, as amended (the “Securities Act”). Accordingly, they do not include all of the information and notes required by U.S. GAAP for complete financial statements. These unaudited condensed consolidated financial statements reflect all adjustments, including normal recurring accruals that the Company believes are necessary to fairly state the financial position and the results of the Company’s operations and cash flows for interim periods in accordance with U.S. GAAP. Interim-period results are not necessarily indicative of results of operations or cash flows for a full year or any subsequent interim period. The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the Company’s audited financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 (the “2023 Form 10-K”) filed with the SEC. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make judgments, estimates and assumptions that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosures. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances. These estimates form the basis for making judgments about the carrying values of assets and liabilities when these values are not readily apparent from other sources. Estimates are assessed each period and updated to reflect current information. Accounting estimates and judgments are inherently uncertain and therefore actual results could differ from these estimates. Cash, Cash Equivalents and Restricted Cash The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheets, which, in aggregate, represent the amount reported in the condensed consolidated statements of cash flows: (in thousands) January 1, At beginning of period: 2024 2023 Cash and cash equivalents $ 102,891 $ 63,547 Restricted cash 452 440 Total cash, cash equivalents and restricted cash $ 103,343 $ 63,987 March 31, At end of period: 2024 2023 Cash and cash equivalents $ 259,775 $ 16,145 Restricted cash 452 440 Total cash, cash equivalents and restricted cash $ 260,227 $ 16,585 Proceeds from the divestiture of the CIMERLI ophthalmology franchise received in March were used to pay down $175.0 million out of the total principal balance of $250.0 million on the Company’s 2027 Term Loan in April 2024 (see Note 13. Subsequent Events). Restricted cash consists of deposits for letters of credit that the Company has provided to secure its obligations under certain leases and is included in other assets, non-current on the condensed consolidated balance sheets. Trade Receivables Trade receivables are recorded net of allowances for chargebacks, cash discounts for prompt payment and credit losses. The Company estimates an allowance for expected credit losses by considering factors such as historical experience, credit quality, the age of the accounts receivable balances, and current economic conditions that may affect a customer’s ability to pay. The corresponding expense for the credit loss allowance is reflected in selling, general and administrative expenses. The credit loss allowance was immaterial as of March 31, 2024 and December 31, 2023. Contingent Consideration Contingent consideration relates to the potential payments to holders of Contingent Value Rights (“CVRs”) 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 selling, general and administrative expense in the condensed 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. 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. 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, which enhances the disclosures required for operating segments by requiring disclosure of significant segment expenses that are regularly provided to the CODM and included within each reported measure of segment profit or loss, among other expanded. All disclosure requirements of ASU 2023-07 are required for entities with a single reportable segment. The new standard is effective for the Company for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. Early adoption is permitted and the amendments in this update should be applied retrospectively to all periods presented. The Company is currently evaluating the impact this ASU may have on its financial statement disclosures. In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which provides qualitative and quantitative updates to the rate reconciliation and income taxes paid disclosures, among others, in order to enhance the transparency of income tax disclosures, including consistent categories and greater disaggregation of information in the rate reconciliation and disaggregation by jurisdiction of income taxes paid. The new standard is effective for the Company for annual periods beginning after December 15, 2024, with early adoption permitted. The amendments in this ASU should be applied prospectively; however, retrospective application is also permitted. The Company is currently evaluating the impact this ASU may have on its financial statement 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 condensed consolidated financial statements as a result of future adoption. |
Revenue
Revenue | 3 Months Ended |
Mar. 31, 2024 | |
Revenue | |
Revenue | 2. Revenue The Company launched LOQTORZI and YUSIMRY in the United States in December and July 2023, respectively, and initiated sales of CIMERLI in October 2022. Net revenue for sales of CIMERLI effectively ceased to be recognized in the Company’s statements of operations on March 1, 2024. All net product revenue was generated in the United States, and the Company’s net revenue was as follows: Three Months Ended March 31, (in thousands) 2024 2023 Products UDENYCA $ 42,667 $ 26,179 CIMERLI 28,194 6,174 YUSIMRY 3,894 — LOQTORZI 1,988 — Total net product revenue 76,743 32,353 Other 320 83 Total net revenue $ 77,063 $ 32,436 Gross product revenues by significant customer as a percentage of total gross product revenues were as follows: Three Months Ended March 31, 2024 2023 McKesson Corporation 42 % 35 % Cencora (previously known as AmeriSource-Bergen Corporation) 42 % 43 % Cardinal Health, Inc. 14 % 21 % 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 unaudited condensed consolidated balance sheets. In connection with the Sale Transaction, the Company retained and will continue to be responsible for sales discounts and allowance liabilities incurred prior to March 1, 2024. Sales discounts and allowances incurred on behalf of the TSA in March 2024 are reflected within TSA payables and other accrued liabilities activities and ending reserve balances for each significant category of discounts and allowances, which constitute variable consideration, were as follows: Three Months Ended March 31, 2024 Chargebacks Other Fees, and Discounts Co-pay for Prompt Assistance (in thousands) Payment Rebates and Returns Total Balances at December 31, 2023 $ 73,953 $ 121,137 $ 49,795 $ 244,885 Provision related to sales made in: Current period 223,619 56,432 42,359 322,410 Prior period - increase (decrease) (504) 1,399 410 1,305 Payments and customer credits issued (228,278) (74,958) (40,799) (344,035) Balances at March 31, 2024 $ 68,790 $ 104,010 $ 51,765 $ 224,565 Three Months Ended March 31, 2023 Chargebacks Other Fees, and Discounts Co-pay for Prompt Assistance (in thousands) Payment Rebates and Returns Total Balances at December 31, 2022 $ 42,677 $ 38,713 $ 19,113 $ 100,503 Provision related to sales made in: Current period 93,906 13,000 14,603 121,509 Prior period - increase (decrease) (738) (701) 1,829 390 Payments and customer credits issued (101,108) (14,243) (16,617) (131,968) Balances at March 31, 2023 $ 34,737 $ 36,769 $ 18,928 $ 90,434 |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2024 | |
Fair Value Measurements | |
Fair Value Measurements | 3. Fair Value Measurements The fair values 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. 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. Realized gains and losses, if any, on available-for-sale securities are included in other income (expense), net, in the condensed consolidated statements of operations based on the specific identification method. In connection with the acquisition (the “Surface Acquisition”) of Surface Oncology, Inc. (“Surface”) on September 8, 2023 (see Note 6. Acquisition and Disposition), the Company recorded a contingent consideration liability related to CVRs issued in connection with the acquisition. The fair value of the CVR liability was determined using a Monte Carlo simulation-based model discounted to present value and represents 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. During the three months ended March 31, 2024, the Company impaired the out-licensed partnership program with Novartis Institutes (NZV930), which resulted in a net impairment charge of $6.8 million in selling, general and administrative expenses in the condensed consolidated statements of operations relating to the write-off of the net carrying value of the Novartis Institutes out-license intangible asset of $10.6 million and the final remeasurement of the CVR liability of $3.8 million to its fair value of zero . The remaining CVR liability associated with GSK of $0.5 million and other contingent consideration are recorded in other liabilities, non-current on the condensed consolidated balance sheets at March 31, 2024. 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 March 31, 2024 (in thousands) Level 1 Level 2 Level 3 Total Financial Assets: Cash equivalents (1) $ 259,413 $ — $ — $ 259,413 Prepaid financial instrument in Prepaid manufacturing (2) — — 432 432 Total $ 259,413 $ — $ 432 $ 259,845 Financial Liabilities: Contingent consideration $ — $ — $ 632 $ 632 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 (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 as described in the Company’s 2023 Form 10-K. Proceeds from the divestiture of the CIMERLI ophthalmology franchise received in March were used to pay down $175.0 million out of the total principal balance of $250.0 million on the Company’s 2027 Term Loans in April 2024 (see Note 13. Subsequent Events). The cost, unrealized gains or losses, and fair value by investment type are summarized as follows: March 31, 2024 (in thousands) Cost Unrealized Gain Unrealized (Loss) Fair Value Money market funds $ 259,413 $ — $ — $ 259,413 Total $ 259,413 $ — $ — $ 259,413 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 |
Inventory
Inventory | 3 Months Ended |
Mar. 31, 2024 | |
Inventory | |
Inventory | 4. Inventory Inventory consisted of the following: March 31, December 31, (in thousands) 2024 2023 Raw materials $ 13,941 $ 12,975 Work in process 90,400 82,588 Finished goods 23,282 34,537 Total $ 127,623 $ 130,100 Inventory as of December 31, 2023 included $16.4 million related to the CIMERLI ophthalmology franchise (see Note 6. Acquisition and Disposition). Inventory is stated at the lower of cost or estimated net realizable value with cost determined under the first-in first-out method. 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, the Company recorded a $47.0 million charge for the write-down of slow moving YUSIMRY inventory, which included the recognition of $20.5 million in certain firm purchase commitments. Of this charge, $11.5 million was reflected in accrued and other current liabilities and $9.0 million in other liabilities, non-current as of December 31, 2023. As of March 31, 2024, $8.6 million of accrued YUSIMRY firm purchase commitments remained within accrued and other current liabilities. Inventory expected to be sold more than twelve months from the balance sheet date is classified as inventory, non-current on the condensed consolidated balance sheets. As of March 31, 2024 and December 31, 2023, the non-current portion of inventory primarily consisted of raw materials and work in process inventory. The following table presents the inventory balance sheet classifications: March 31, December 31, (in thousands) 2024 2023 Inventory $ 61,978 $ 62,605 Inventory, non-current 65,645 67,495 Total $ 127,623 $ 130,100 Prepaid manufacturing of $7.5 million as of March 31, 2024 includes prepayments of $3.8 million to contract manufacturing organizations (“CMOs”) for manufacturing services, which the Company expects to be converted into inventory within the next twelve months, and prepayments of $3.7 million to various CMOs for research and development pipeline programs. Prepaid manufacturing of $23.7 million as of December 31, 2023 included prepayments of $12.6 million to CMOs for manufacturing services, including $6.4 million related to the CIMERLI ophthalmology franchise (see Note 6. Acquisition and Disposition), and prepayments of $11.1 million to various CMOs for research and development pipeline programs. |
Balance Sheet Components
Balance Sheet Components | 3 Months Ended |
Mar. 31, 2024 | |
Balance Sheet Components | |
Balance Sheet Components | 5. Balance Sheet Components Property and Equipment, Net Property and equipment, net consisted of the following: March 31, December 31, (in thousands) 2024 2023 Machinery and equipment $ 13,124 $ 13,124 Computer equipment and software 3,566 3,546 Furniture and fixtures 1,055 1,055 Leasehold improvements 5,751 5,751 Finance lease right of use assets 1,290 2,294 Total property and equipment 24,786 25,770 Accumulated depreciation and amortization (20,598) (20,651) Property and equipment, net $ 4,188 $ 5,119 Depreciation and amortization expense related to property and equipment, net was $0.6 million and $0.9 million for the three months ended March 31, 2024 and 2023, respectively. As of March 31, 2024 and December 31, 2023, the net book value of software implementation costs related to hosting arrangements was $3.2 million and $3.2 million, respectively, and the amortization expense was immaterial for all periods presented. Intangible Assets, Net Intangible assets, net consisted of the following: March 31, December 31, (in thousands) 2024 2023 Finite-lived assets, net of accumulated amortization of $812 and $639, as of March 31, 2024 and December 31, 2023, respectively $ 28,245 $ 41,871 Indefinite-lived assets - in-process research and development 28,859 28,859 Goodwill — 943 Total Intangible assets, net $ 57,104 $ 71,673 Amortization expense related to finite-lived intangible assets was immaterial in all periods presented. In connection with the Sale Transaction on March 1, 2024, a finite-lived asset, net of $2.1 million and goodwill of $0.9 million were derecognized. The exclusive license of NZV930 to Novartis Institutes, acquired as part of the Surface Acquisition, was terminated by Novartis Institutes with an effective date of October 2, 2024. As a result, the Company recognized an impairment charge of $10.6 million for the carrying value of the Novartis Institutes out-license during the three months ended March 31, 2024, which was classified within selling, general and administrative expense in the condensed consolidated statements of operations. Amortization expense for the remaining finite-lived assets for each of the five succeeding fiscal years is expected to be $2.8 million. Accrued and Other Current Liabilities Accrued and other current liabilities consisted of the following: March 31, December 31, (in thousands) 2024 2023 Accrued commercial and research and development manufacturing $ 37,283 $ 23,470 Accrued co-development costs and milestone payments 25,000 26,812 Accrued royalties 35,342 42,031 Accrued other 16,271 7,628 Lease liabilities, current 1,811 2,145 Contingent consideration, current — 3,300 Total Accrued and other current liabilities $ 115,707 $ 105,386 Other Liabilities, Non-current Other liabilities, non-current consisted of the following: March 31, December 31, (in thousands) 2024 2023 Contingent consideration, non-current $ 632 $ 1,172 Deferred tax liability 1,102 1,102 Other 1,000 10,287 Total Other liabilities, non-current $ 2,734 $ 12,561 |
Acquisition and Disposition
Acquisition and Disposition | 3 Months Ended |
Mar. 31, 2024 | |
Acquisition and Disposition | |
Acquisition and Disposition | 6. Acquisition and Disposition 2024 - Sale Transaction On March 1, 2024, the Company completed the Sale Transaction for its CIMERLI ophthalmology franchise through the sale of its subsidiary, Coherus Ophthalmology, 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. During the first quarter of 2024, the Company recognized a net gain on the Sale Transaction of $153.6 million, which includes the cash receipts of $187.8 million less assets transferred to Sandoz, assets derecognized, transaction costs of $7.2 million, and other related employee transition expenses As of March 31, 2024, unpaid transaction costs and committed for retention bonuses totaled $11.1 million. The pretax profit (loss) related to the CIMERLI ophthalmology franchise prior to the Sale Transaction, which excludes any corporate overhead allocations, was $7.4 million and $(3.9) million during the three months ended March 31, 2024 and 2023, respectively. In connection with the Sale Transaction, the Company and Sandoz entered into a Transition Services Agreement (“TSA”), pursuant to which the Company is providing certain business support services on behalf of Sandoz including billings, collections, and the remittance of rebates, to ensure business continuity for patients and customers for a period not expected to extend beyond December 31, 2024. ncome of $0.3 million for the three months ended March 31, 2024 in other income (expense), net in the condensed consolidated statements of operations 2023 - Surface Acquisition On September 8, 2023 (the “Acquisition Date”), in accordance with an Agreement and Plan of Merger dated June 15, 2023 (the “Merger Agreement”) by and among the Company, Crimson Merger Sub I, Inc. (“Merger Sub I”), Crimson Merger Sub II, LLC (“Merger Sub II,” and together with Merger Sub I, the “Merger Subs”), and Surface, the Company completed the Surface Acquisition. The Surface Acquisition expanded the Company’s I-O pipeline with the following: casdozokitug ( 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 10-year ● 70% of all milestone- and royalty-based payments actually received by the Company or its affiliates from GSK under a license agreement with GSK, dated December 16, 2020, which was subsequently amended in August 2021 (as amended, the “GSK Agreement”) related to the existing program (GSK4381562) ; ● 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 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 was 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. selling, general and administrative expenses |
Collaborations and Other Arrang
Collaborations and Other Arrangements | 3 Months Ended |
Mar. 31, 2024 | |
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 an Exclusive License and Commercialization Agreement (the “Collaboration Agreement”) with Junshi Biosciences for the co-development and commercialization of LOQTORZI Under the terms of the Collaboration Agreement, the Company paid $150.0 million upfront for exclusive rights to LOQTORZI LOQTORZI LOQTORZI In March 2022, the Company paid $35.0 million for the exercise of its option to license CHS-006. Subsequent joint development consistent with the Collaboration Agreement commenced. On January 10, 2024, the Company announced that it had delivered a notice of termination of the to Junshi Biosciences. The Company plans to continue to wind down work with Junshi Biosciences on the TIGIT Program pursuant to the termination. LOQTORZI LOQTORZI In March 2024, the Company entered into an Amendment No. 2 to the Collaboration Agreement (the “2 nd Amendment”) with Junshi Biosciences to revise the timing of the $25.0 million milestone payment to Junshi Biosciences that became due in connection with the approval by the FDA of toripalimab for the treatment of patients with NPC in the first quarter of 2024. Both parties agreed to split the $25.0 million milestone payment into two equal installments of $12.5 million each, one that was paid in the second quarter of 2024 and one due in the first quarter of 2025. The licensing transaction and the exercise of the option were accounted for as asset acquisitions under the relevant accounting rules. During the three months ended March 31, 2024, the Company recognized a reduction in research and development expenses for the release of certain liabilities of $4.8 million pursuant to the 2 nd The accrued royalty obligation to Junshi Biosciences was immaterial as of March 31, 2024 and December 31, 2023. The additional milestone payments, option fee for the IL-2 cytokine and royalties are contingent upon future events and, therefore, will be recorded if and when it becomes probable that a milestone will be achieved, or when an option fee or royalties are incurred. Bioeq On November 4, 2019, the Company entered into a license agreement with Bioeq AG (“Bioeq”) (the “Bioeq License Agreement”) for the commercialization of CIMERLI, a biosimilar version of ranibizumab (Lucentis), in certain dosage forms in both a vial and pre-filled syringe presentation (the “Bioeq Licensed Products”). Under the Bioeq License 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. Royalties due to Bioeq were $32.7 million and $38.4 million as of March 31, 2024 and December 31, 2023, respectively. On January 19, 2024 the Company entered into the Purchase Agreement with Sandoz Inc. Pursuant to the Purchase Agreement, on March 1, 2024, the Company completed the divestiture of its CIMERLI ophthalmology franchise through the sale of its subsidiary, Coherus Ophthalmology, for upfront, all-cash consideration of $170.0 million plus an additional $17.8 million for CIMERLI product inventory and prepaid manufacturing assets. Refer to Note 6. Acquisition and Disposition for additional information. Upon closing of the Sale Transaction, the Bioeq License Agreement was assumed by Sandoz. Refer to the Company’s Annual Report on 2023 Form 10-K filed March 15, 2024 for additional information related to the Bioeq License Agreement. Adimab Development and Option Agreement In October 2018, Surface and Adimab LLC (“Adimab”), entered into an amended and restated development and option agreement, (as amended by the amendments dated as of December 16, 2020, June 1, 2022 and July 18, 2022, “the A&R Adimab Agreement”), which amended and restated the development and option agreement with Adimab dated July 2014, as amended, (“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. Adimab granted the Company an exclusive option to obtain a non-exclusive, worldwide, fully paid-up, sublicensable license under Adimab’s platform patents and other Adimab technology solely to research up to ten antibodies, chosen by the Company against a specific biological target for a specified period of time (the “Research Option”). In addition, Adimab granted the Company an exclusive option to obtain a worldwide, royalty-bearing, sublicensable license under Adimab platform patents and other Adimab technology to exploit, including commercially, 20 or more antibodies against specific biological targets (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 the balance and choosing additional antibodies for commercialization, up to the maximum number under the Commercialization Option, or (ii) foregoing the Commercialization Option entirely. For any Adimab diagnostic product that is used with or in connection with any compound or product other than a licensed antibody or licensed product, the Company is obligated to pay Adimab up to a low seven digits in regulatory milestone payments and low single-digit royalties on net sales. 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. Acquisition and Disposition. Vaccinex License Agreement On March 23, 2021, Surface and Vaccinex, Inc. (“Vaccinex”) entered into an exclusive product license agreement (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 licensed products that incorporate certain Vaccinex intellectual property which covers certain antibodies (each, a “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. Novartis Institutes In January 2016, Surface entered into the . Pursuant to the Novartis Agreement, Surface granted Novartis Institutes a worldwide exclusive license to research, develop, manufacture and commercialize antibodies that target cluster of diffe rentiation 73 (“CD73”). Under the Novartis Agreement, the Company was 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. Novartis Institutes has terminated the exclusive license of NZV930 with an effective date of October 2, 2024. The Company did not recognize any revenue relating to the Novartis Agreement during the three months ended March 31, 2024. 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 antibodies that target CD112R, also known as PVRIG, including the antibody GSK4381562 (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. In March 2022, Surface earned a $30.0 million milestone payment from GSK upon the dosing of the first patient in the Phase 1 trial of GSK4381562. The Company is eligible to receive up to $60.0 million in additional clinical milestones and $155.0 million in regulatory milestones. In addition, the Company may receive up to $485.0 million in sales milestone payments. The Company is also eligible to receive royalties on global net sales of any approved products based on the Licensed Antibodies, ranging in percentages from high single digits to mid-teens. 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 GSK Agreement. 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 | 3 Months Ended |
Mar. 31, 2024 | |
Debt Obligations | |
Debt Obligations | 8. Debt Obligations A summary of the Company’s debt obligations, including level within the fair value hierarchy (see Note 3. Fair Value Measurements), was as follows: At March 31, 2024 (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 $ (2,548) $ 247,452 $ 247,452 Level 2* 2026 Convertible Notes $ 230,000 $ (2,780) $ 227,220 $ 142,888 Level 2** 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** * 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. ** The fair value is influenced by interest rates, the Company’s stock price and stock price volatility and is determined by prices observed in market trading. Since the market for trading of the 2026 Convertible Notes is not considered to be an active market, the estimated fair value is based on Level 2 inputs. 2027 Term Loans The Company entered into a loan agreement in January 2022 (as amended to date, the “Loan Agreement”) with BioPharma Credit, PLC, (as the “Collateral Agent”), BPCR Limited Partnership (as a “Lender”), and Biopharma Credit Investments V (Master) LP, acting by its general partner, BioPharma Credit Investments V GP LLC (as a “Lender”) that provides for a senior secured term loan facility of up to $300.0 million to be funded in four committed tranches: (i) a Tranche A Loan in an aggregate principal amount of $100.0 million (the “Tranche A Loan”) that was funded on January 5, 2022 (the “Tranche A Closing Date”); (ii) a Tranche B Loan in an aggregate principal amount of $100.0 million (the “Tranche B Loan”) that was funded on March 31, 2022; (iii) a Tranche C Loan in an aggregate principal amount of $50.0 million (the “Tranche C Loan”) that was not funded; and (iv) a Tranche D Loan in an aggregate principal amount of $50.0 million (the “Tranche D Loan” and, together with the Tranche A Loan, the Tranche B Loan, and the Tranche C Loan, the “2027 Term Loans”) 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 2026 Convertible Notes is greater than $50.0 million on October 1, 2025. Since April 1, 2023, the 2027 Term Loans accrue interest at 8.25% plus the sum (the “Adjusted Term SOFR”) of three-month SOFR and 0.26161% per annum, with a floor on Adjusted Term SOFR of 1.0%. The interest rate for the first quarter of 2024 was 13.84%. 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. On February 5, 2024, the Company entered into a Consent, Partial Release and Third Amendment to the 2027 Term Loans (the “Consent and Amendment”) with the Collateral Agent and the Lenders. 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 required the Company to make a partial prepayment of the principal of the loans outstanding under the Loan Agreement in the amount of $175.0 million upon consummation of the transactions contemplated by the Purchase Agreement, subject to certain conditions and (3) the parties thereto agreed to adjust the minimum net trailing twelve month net sales covenant level to be $125.0 million under the Loan Agreement. Other terms of the Loan Agreement, as amended by the Consent and Amendment, remain generally identical to those under the Loan Agreement. Upon the closing of the Sale Transaction the Company became obligated to repay $175.0 million of the total principal balance of $250.0 million of the loans outstanding under the Loan Agreement on April 1, 2024, and the $175.0 million was classified as term loans, current in the condensed consolidated balance sheets as of March 31, 2024. The Company repaid the $175.0 million in April 2024 pursuant to the Consent and Amendment (see Note 13. Subsequent Events). 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 increased 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 make investments, engage in certain mergers and acquisitions or asset sales, and declare dividends or redeem or repurchase capital stock. The Loan Agreement also contains customary events of default, including among other things, the Company’s failure to make any principal or interest payments when due, the occurrence of certain bankruptcy or insolvency events or its breach of the covenants under the Loan Agreement. Upon the occurrence of an event of default, the Lenders may, among other things, accelerate the Company’s obligations under the Loan Agreement. A change of control of the Company triggers a mandatory prepayment of the 2027 Term Loans within ten business days. As of March 31, 2024, the Company was in full compliance with these covenants, and there were no events of default under the 2027 Term Loans. As of March 31, 2024, the total remaining unamortized debt discount and debt offering costs related to Tranches A, B and D of $2.5 million will be amortized using the effective interest rate over the remaining term of 2.8 years. The following table presents the components of interest expense related to the 2027 Term Loans: Three Months Ended March 31, (in thousands) 2024 2023 Contractual interest $ 8,747 $ 8,145 Amortization of debt discount and debt issuance costs 972 332 Total interest expense $ 9,719 $ 8,477 During the second quarter of 2024, the Company fully repaid the 2027 Term Loans by paying $175.0 million principal on April 1, 2024 and $75.0 million principal on May 8, 2024 (see Note 13. Subsequent Events). 1.5% Convertible Senior Subordinated Notes due 2026 In April 2020, the Company issued and sold $230.0 million aggregate principal amount of its 1.5% Convertible Senior Subordinated notes due 2026 (the “2026 Convertible Notes”) in a private offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act. The net proceeds from the offering were $222.2 million after deducting initial purchasers’ fees and offering expenses. The 2026 Convertible Notes are general unsecured obligations and will be subordinated to the Company’s designated senior indebtedness (as defined in the indenture for the 2026 Convertible Notes) and structurally subordinated to all existing and future indebtedness and other liabilities, including trade payables 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. Since inception, the conversion price has been 51.9224 shares of common stock per $1,000 principal amount of the 2026 Convertible Notes, which represents a 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 March 31, 2024, the Company was in full compliance with these covenants and there were no events of default under the 2026 Convertible Notes. The Company evaluated the features embedded in the 2026 Convertible Notes under the relevant accounting rules and concluded that the embedded features do not meet the requirements for bifurcation, and therefore do not need to be separately accounted for as an equity component. The proceeds received from the issuance of the convertible debt were recorded as a liability on the condensed 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; thus, they are recorded as a reduction to additional paid-in capital on the condensed consolidated balance sheets. The capped calls will not be subsequently re-measured as long as the conditions for equity classification continue to be met. The Company incurred $0.9 million of debt issuance costs relating to the issuance of the 2026 Convertible Notes, which were recorded as a reduction to the notes on the condensed consolidated balance sheets. 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 March 31, 2024, the holders of the 2026 Convertible Notes would have received common shares with an aggregate value of $28.5 million based on the Company’s closing stock price of $2.39 as of March 28, 2024. The following table presents the components of interest expense related to the 2026 Convertible Notes: Three Months Ended March 31, (in thousands) 2024 2023 Stated coupon interest $ 863 $ 863 Amortization of debt discount and debt issuance costs 332 326 Total interest expense $ 1,195 $ 1,189 The remaining unamortized debt discount and debt offering costs related to the 2026 Convertible Notes of $2.8 million as of March 31, 2024 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 March 31, 2024 are as follows: Year ending December 31, (in thousands) Remainder of 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 (2,780) Net carrying amount of 2026 Convertible Notes $ 227,220 |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2024 | |
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 March 31, 2024, the Company’s non-cancelable purchase commitments under the terms of its agreements are as follows: Year ending December 31, (in thousands) 2024 $ 30,609 2025 32,013 2026 1,410 Total obligations $ 64,032 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 generally 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 is 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 March 31, 2024 and December 31, 2023, the Company had an accrual of $6.4 million related to such matters that was included in accrued rebates, fees and reserves on the condensed 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 March 31, 2024 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. Commitments and Contingencies, 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. |
Stockholders' Deficit
Stockholders' Deficit | 3 Months Ended |
Mar. 31, 2024 | |
Stockholders' Deficit | |
Stockholders' Deficit | 10. Stockholders’ Deficit Public Offering On May 16, 2023, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with J.P. Morgan Securities LLC and Citigroup Global Markets Inc., as representatives of the several underwriters named therein (collectively, the “Underwriters”), pursuant to which the Company issued and sold an aggregate of 11,764,706 shares (the “Firm Shares”) of its common stock, par value $0.0001 per share, to the Underwriters (the “Public Offering”). 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 up to an additional 1,764,705 shares of common stock (the “Option Shares,” and together with the Firm Shares, the “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 shelf registration statement on Form S-3 that was declared effective on November 17, 2022 (the “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 the Registration Statement. Also on November 8, 2022, the Company entered into a sales agreement (“Sales Agreement”) with Cowen and Company, LLC (“TD 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 TD Cowen as the Company’s sales agent or principal in an at-the-market offering (“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 amount of shares that could be issued and sold pursuant to its ATM Offering with TD Cowen by $86.2 million, lowering the aggregate offering price under the Sales Agreement from $150.0 million to $63.8 million. On September 11, 2023, pursuant to an Amendment No. 2 to Sales Agreement, the Company increased the amount of shares that could be issued and sold pursuant to its ATM Offering with TD Cowen by $28.7 million, increasing the aggregate offering price under the Sales Agreement from $63.8 million to $92.5 million. The following table summarizes information regarding settlements under the ATM Offering: Three Months Ended March 31, (in thousands, except share and per share data) 2024 2023 Number of common stock shares sold during the period 650,005 1,131,450 Weighted-average price per share $ 2.44 $ 6.54 Gross proceeds $ 1,589 $ 7,401 Less commissions and fees (40) (185) Net proceeds after commissions and fees $ 1,549 $ 7,216 As of March 31, 2024, the Company had approximately $64.9 million of its common stock remaining available for sales under the ATM Offering. |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2024 | |
Stock-Based Compensation | |
Stock-Based Compensation | 11. Stock-Based Compensation The following table summarizes the classification of stock-based compensation expense in the Company’s condensed consolidated statements of operations related to options and restricted stock units granted to employees and nonemployees: Three Months Ended March 31, (in thousands) 2024 2023 Cost of goods sold (1) $ 248 $ 125 Research and development 2,194 5,461 Selling, general and administrative 4,877 6,696 Stock-based compensation expense $ 7,319 $ 12,282 Stock-based compensation expense capitalized into inventory $ 394 $ 131 Stock-based compensation capitalized into inventory is recognized as cost of goods sold when the related product is sold. |
Net Income (Loss) Per Share
Net Income (Loss) Per Share | 3 Months Ended |
Mar. 31, 2024 | |
Net Income (Loss) Per Share | |
Net Income (Loss) Per Share | 12. Net Income (Loss) Per Share Basic net income (loss) per share is calculated by dividing the net income (loss) by the weighted-average number of shares of common stock outstanding for the period, without consideration for potential dilutive common shares. Diluted net income per share is computed by dividing the net income by the weighted average number of common shares outstanding for the period plus any diluted potential common shares outstanding for the period determined using the treasury stock method for options, RSUs and ESPP and using the if-converted method for the convertible notes. Diluted net l The following table sets forth the computation of the basic and diluted net income (loss) per share: Three Months Ended March 31, (in thousands, except share and per share data) 2024 2023 Basic net income (loss) per share Numerator: Net income (loss) $ 102,875 $ (75,729) Denominator: Weighted-average common shares outstanding 112,749,306 79,268,853 Basic net income (loss) per share $ 0.91 $ (0.96) Diluted net income (loss) per share Numerator: Net income (loss) $ 102,875 $ (75,729) Add interest expense on convertible notes, net of tax 1,195 — Numerator for diluted net income (loss) per share $ 104,070 $ (75,729) Denominator: Denominator for basic net income (loss) per share 112,749,306 79,268,853 Add effect of potential dilutive securities: Stock options, including shares subject to ESPP 406,217 — Restricted stock units 432,296 — Shares issuable upon conversion of convertible notes 11,942,152 — Denominator for diluted net income (loss) income per share 125,529,971 79,268,853 Diluted net income (loss) per share $ 0.83 $ (0.96) The following outstanding dilutive potential shares were excluded from the calculation of diluted net income (loss) per share due to their anti-dilutive effect: Three Months Ended March 31, 2024 2023 Stock options, including shares subject to ESPP 26,109,011 23,996,096 Restricted stock units 1,066,705 2,586,168 Shares issuable upon conversion of 2026 Convertible Notes — 11,942,152 Total 27,175,716 38,524,416 The amounts in the table above exclude any shares contingently issuable pursuant to the CVR Agreement because the conditions that could result in a payment becoming due were not met. |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2024 | |
Subsequent Events | |
Subsequent Events | 13. Subsequent Events Partial Release and Third Amendment to 2027 Term Loans On April 1, 2024, the Company repaid $175.0 million of the total principal balance of $250.0 million outstanding on the 2027 Term Loans, and the prepayment premium and make-whole amount of $6.8 million to the Lenders pursuant to the Consent and Amendment dated February 5, 2024 (see Note 8. Debt Obligations). 2029 Term Loan On May 8, 2024, the Company entered into a senior secured term loan facility of up to $38.7 million (the “2029 Term Loan”), all to be funded on May 8, 2024 (the “2029 Term Loan Effective Date”), with Ankura Trust Company, LLC, as administrative agent (in such capacity, the “Agent”), and the lenders signatory thereto (collectively, the “2029 Lenders”). The proceeds of the 2029 Term Loan were used by the Company to help repay in full the existing outstanding indebtedness under the 2027 Term Loans. The 2029 Term Loan is governed by a loan agreement, dated as of the 2029 Term Loan Effective Date, by and among the Company, the Agent and the 2029 Lenders (the “2029 Loan Agreement”). The 2029 Term Loan will mature on May 8, 2029. The amounts borrowed under the 2029 Term Loan accrue interest at a per annum rate equal to 8.00% per annum, plus a three-month SOFR rate. The 2029 Term Loan provides for interest-only payments on a quarterly basis until maturity. The Company may prepay the 2029 Term Loan in full or in part provided that the Company (i) provides at least three (3) business days’ prior written notice to the Agent, (ii) pays on the date of such prepayment (A) all outstanding principal to be prepaid plus accrued and unpaid interest, (B) a prepayment fee of (x) 10.00% of the 2029 Term Loan so prepaid if paid on or after the first anniversary of the 2029 Term Loan Effective Date and before the second anniversary of the 2029 Term Loan Effective Date; (y) 5.00% of the 2029 Term Loan so prepaid if paid after the second anniversary of the 2029 Term Loan Effective Date and on or before the third anniversary of the 2029 Term Loan Effective Date; and (z) 0.00% of the 2029 Term Loan so prepaid if paid after the third anniversary of the 2029 Term Loan Effective Date and (C) all other sums, if any, that shall become due and payable under the 2029 Loan Agreement, including interest at the default rate with respect to any past due amounts. Amounts outstanding during an event of default shall accrue interest at an additional rate of 4.00% per annum, which interest shall be payable on demand in cash. The 2029 Term Loan is secured by a lien on substantially all of the assets of the Company, including intellectual property, subject to customary exclusions and exceptions. The 2029 Loan Agreement contains customary representations and warranties, covenants and events of default, including a financial covenant commencing on the 2029 Term Loan Effective Date, which requires the Company to maintain certain levels of cash and cash equivalents. The 2029 Loan Agreement also contains other customary provisions, such as expense reimbursement, as well as indemnification rights for the benefit of the Agent and the 2029 Lenders. In connection with the entry into the 2029 Loan Agreement on May 8, 2024, the Company repaid in full all outstanding indebtedness and terminated all commitments under the 2027 Term Loans. The aggregate principal amount outstanding under the 2027 Term Loans was $75.0 million at the time of repayment. The Company did not incur any penalties but did pay a prepayment premium and make-whole amount of $3.5 million. Revenue Participation Right Purchase and Sale Agreement On May 8, 2024, the Company entered into a revenue participation right purchase and sale agreement (the “Revenue Purchase and Sale Agreement”) with Coduet Royalty Holdings, LLC, as administrative agent and each buyer named in an annex thereto (collectively, the “Purchaser”). Under the terms of the Revenue Purchase and Sale Agreement, in exchange for the Purchaser’s payment to the Company of a purchase price of $37.5 million, in the aggregate subject to certain conditions at closing (the “Purchase Price”), the Company has agreed to sell to the Purchaser its right to receive payment in full of a mid-single digit percentage of U.S. net sales of UDENYCA and LOQTORZI (the “Revenue Payment”) with payments made each calendar quarter commencing on the effective date of the Revenue Purchase and Sale Agreement. The Purchaser’s right to receive the Revenue Payment terminates and the Company no longer has the obligation to pay the Purchaser Revenue Payments once the Purchaser receives the amount equal to 2.25 times the Purchase Price. The Company may also buy-out the Purchaser’s rights to receive the Revenue Payments by paying Purchaser such multiple on the Purchaser Price. The Revenue Purchase and Sale Agreement contains various representations and warranties, including with respect to organization, authorization, and certain other matters, certain covenants with respect to payment, reporting, intellectual property, in-licenses, out-licenses, and certain other actions, indemnification obligations and other provisions customary for transactions of this nature. |
Organization and Summary of S_2
Organization and Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2024 | |
Organization and Summary of Significant Accounting Policies | |
Basis of Consolidation | Basis of Consolidation The accompanying unaudited condensed consolidated financial statements include the accounts of Coherus and its wholly-owned subsidiaries. All intercompany transactions and balances have been eliminated upon consolidation. The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with United States generally accepted accounting principles (“U.S. GAAP”) for interim financial information and in accordance with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X of the Securities Act of 1933, as amended (the “Securities Act”). Accordingly, they do not include all of the information and notes required by U.S. GAAP for complete financial statements. These unaudited condensed consolidated financial statements reflect all adjustments, including normal recurring accruals that the Company believes are necessary to fairly state the financial position and the results of the Company’s operations and cash flows for interim periods in accordance with U.S. GAAP. Interim-period results are not necessarily indicative of results of operations or cash flows for a full year or any subsequent interim period. The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the Company’s audited financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 (the “2023 Form 10-K”) filed with the SEC. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make judgments, estimates and assumptions that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosures. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances. These estimates form the basis for making judgments about the carrying values of assets and liabilities when these values are not readily apparent from other sources. Estimates are assessed each period and updated to reflect current information. Accounting estimates and judgments are inherently uncertain and therefore actual results could differ from these estimates. |
Cash, Cash Equivalents and Restricted Cash | Cash, Cash Equivalents and Restricted Cash The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheets, which, in aggregate, represent the amount reported in the condensed consolidated statements of cash flows: (in thousands) January 1, At beginning of period: 2024 2023 Cash and cash equivalents $ 102,891 $ 63,547 Restricted cash 452 440 Total cash, cash equivalents and restricted cash $ 103,343 $ 63,987 March 31, At end of period: 2024 2023 Cash and cash equivalents $ 259,775 $ 16,145 Restricted cash 452 440 Total cash, cash equivalents and restricted cash $ 260,227 $ 16,585 Proceeds from the divestiture of the CIMERLI ophthalmology franchise received in March were used to pay down $175.0 million out of the total principal balance of $250.0 million on the Company’s 2027 Term Loan in April 2024 (see Note 13. Subsequent Events). Restricted cash consists of deposits for letters of credit that the Company has provided to secure its obligations under certain leases and is included in other assets, non-current on the condensed consolidated balance sheets. |
Trade Receivables | Trade Receivables Trade receivables are recorded net of allowances for chargebacks, cash discounts for prompt payment and credit losses. The Company estimates an allowance for expected credit losses by considering factors such as historical experience, credit quality, the age of the accounts receivable balances, and current economic conditions that may affect a customer’s ability to pay. The corresponding expense for the credit loss allowance is reflected in selling, general and administrative expenses. The credit loss allowance was immaterial as of March 31, 2024 and December 31, 2023. |
Contingent Consideration | Contingent Consideration Contingent consideration relates to the potential payments to holders of Contingent Value Rights (“CVRs”) 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 selling, general and administrative expense in the condensed 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. |
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. |
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, which enhances the disclosures required for operating segments by requiring disclosure of significant segment expenses that are regularly provided to the CODM and included within each reported measure of segment profit or loss, among other expanded. All disclosure requirements of ASU 2023-07 are required for entities with a single reportable segment. The new standard is effective for the Company for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. Early adoption is permitted and the amendments in this update should be applied retrospectively to all periods presented. The Company is currently evaluating the impact this ASU may have on its financial statement disclosures. In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which provides qualitative and quantitative updates to the rate reconciliation and income taxes paid disclosures, among others, in order to enhance the transparency of income tax disclosures, including consistent categories and greater disaggregation of information in the rate reconciliation and disaggregation by jurisdiction of income taxes paid. The new standard is effective for the Company for annual periods beginning after December 15, 2024, with early adoption permitted. The amendments in this ASU should be applied prospectively; however, retrospective application is also permitted. The Company is currently evaluating the impact this ASU may have on its financial statement 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 condensed consolidated financial statements as a result of future adoption. |
Organization and Summary of S_3
Organization and Summary of Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Organization and Summary of Significant Accounting Policies | |
Schedule of Reconciliation of Cash, Cash Equivalents and Restricted Cash | The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheets, which, in aggregate, represent the amount reported in the condensed consolidated statements of cash flows: (in thousands) January 1, At beginning of period: 2024 2023 Cash and cash equivalents $ 102,891 $ 63,547 Restricted cash 452 440 Total cash, cash equivalents and restricted cash $ 103,343 $ 63,987 March 31, At end of period: 2024 2023 Cash and cash equivalents $ 259,775 $ 16,145 Restricted cash 452 440 Total cash, cash equivalents and restricted cash $ 260,227 $ 16,585 |
Revenue (Tables)
Revenue (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Revenue | |
Schedule of Net product revenue in United States, and Company's net revenue | Three Months Ended March 31, (in thousands) 2024 2023 Products UDENYCA $ 42,667 $ 26,179 CIMERLI 28,194 6,174 YUSIMRY 3,894 — LOQTORZI 1,988 — Total net product revenue 76,743 32,353 Other 320 83 Total net revenue $ 77,063 $ 32,436 |
Schedule of Gross Revenues by Significant Customer as a Percentage of Total Gross Revenues | Gross product revenues by significant customer as a percentage of total gross product revenues were as follows: Three Months Ended March 31, 2024 2023 McKesson Corporation 42 % 35 % Cencora (previously known as AmeriSource-Bergen Corporation) 42 % 43 % Cardinal Health, Inc. 14 % 21 % |
Schedule of Activities and Ending Reserve Balances for Each Significant Category of Discounts and Allowances | Three Months Ended March 31, 2024 Chargebacks Other Fees, and Discounts Co-pay for Prompt Assistance (in thousands) Payment Rebates and Returns Total Balances at December 31, 2023 $ 73,953 $ 121,137 $ 49,795 $ 244,885 Provision related to sales made in: Current period 223,619 56,432 42,359 322,410 Prior period - increase (decrease) (504) 1,399 410 1,305 Payments and customer credits issued (228,278) (74,958) (40,799) (344,035) Balances at March 31, 2024 $ 68,790 $ 104,010 $ 51,765 $ 224,565 Three Months Ended March 31, 2023 Chargebacks Other Fees, and Discounts Co-pay for Prompt Assistance (in thousands) Payment Rebates and Returns Total Balances at December 31, 2022 $ 42,677 $ 38,713 $ 19,113 $ 100,503 Provision related to sales made in: Current period 93,906 13,000 14,603 121,509 Prior period - increase (decrease) (738) (701) 1,829 390 Payments and customer credits issued (101,108) (14,243) (16,617) (131,968) Balances at March 31, 2023 $ 34,737 $ 36,769 $ 18,928 $ 90,434 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Fair Value Measurements | |
Schedule of Financial Assets and Liabilities Measured on a Recurring Basis | 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 March 31, 2024 (in thousands) Level 1 Level 2 Level 3 Total Financial Assets: Cash equivalents (1) $ 259,413 $ — $ — $ 259,413 Prepaid financial instrument in Prepaid manufacturing (2) — — 432 432 Total $ 259,413 $ — $ 432 $ 259,845 Financial Liabilities: Contingent consideration $ — $ — $ 632 $ 632 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 (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 as described in the Company’s 2023 Form 10-K. |
Schedule of Cash and cash equivalents, marketable securities and restricted cash | March 31, 2024 (in thousands) Cost Unrealized Gain Unrealized (Loss) Fair Value Money market funds $ 259,413 $ — $ — $ 259,413 Total $ 259,413 $ — $ — $ 259,413 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 |
Inventory (Tables)
Inventory (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Inventory | |
Schedule of Inventory | Inventory consisted of the following: March 31, December 31, (in thousands) 2024 2023 Raw materials $ 13,941 $ 12,975 Work in process 90,400 82,588 Finished goods 23,282 34,537 Total $ 127,623 $ 130,100 |
Schedule of Balance Sheet Classification | March 31, December 31, (in thousands) 2024 2023 Inventory $ 61,978 $ 62,605 Inventory, non-current 65,645 67,495 Total $ 127,623 $ 130,100 |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Organization and Operations | |
Schedule of Property and Equipment, Net | Property and equipment, net consisted of the following: March 31, December 31, (in thousands) 2024 2023 Machinery and equipment $ 13,124 $ 13,124 Computer equipment and software 3,566 3,546 Furniture and fixtures 1,055 1,055 Leasehold improvements 5,751 5,751 Finance lease right of use assets 1,290 2,294 Total property and equipment 24,786 25,770 Accumulated depreciation and amortization (20,598) (20,651) Property and equipment, net $ 4,188 $ 5,119 |
Schedule of Goodwill and Intangible Assets, Net | March 31, December 31, (in thousands) 2024 2023 Finite-lived assets, net of accumulated amortization of $812 and $639, as of March 31, 2024 and December 31, 2023, respectively $ 28,245 $ 41,871 Indefinite-lived assets - in-process research and development 28,859 28,859 Goodwill — 943 Total Intangible assets, net $ 57,104 $ 71,673 |
Schedule of Accrued Liabilities | Accrued and other current liabilities consisted of the following: March 31, December 31, (in thousands) 2024 2023 Accrued commercial and research and development manufacturing $ 37,283 $ 23,470 Accrued co-development costs and milestone payments 25,000 26,812 Accrued royalties 35,342 42,031 Accrued other 16,271 7,628 Lease liabilities, current 1,811 2,145 Contingent consideration, current — 3,300 Total Accrued and other current liabilities $ 115,707 $ 105,386 |
Schedule of Other Liabilities, Non-current | March 31, December 31, (in thousands) 2024 2023 Contingent consideration, non-current $ 632 $ 1,172 Deferred tax liability 1,102 1,102 Other 1,000 10,287 Total Other liabilities, non-current $ 2,734 $ 12,561 |
Acquisition and Disposition (Ta
Acquisition and Disposition (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Acquisition and Disposition | |
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 |
Debt Obligations (Tables)
Debt Obligations (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Debt Instrument | |
Schedule of Company's Debt Obligations | A summary of the Company’s debt obligations, including level within the fair value hierarchy (see Note 3. Fair Value Measurements), was as follows: At March 31, 2024 (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 $ (2,548) $ 247,452 $ 247,452 Level 2* 2026 Convertible Notes $ 230,000 $ (2,780) $ 227,220 $ 142,888 Level 2** 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** * 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. ** The fair value is influenced by interest rates, the Company’s stock price and stock price volatility and is determined by prices observed in market trading. Since the market for trading of the 2026 Convertible Notes is not considered to be an active market, the estimated fair value is based on Level 2 inputs. |
2027 Term Loans | |
Debt Instrument | |
Schedule of Components of Interest Expense | The following table presents the components of interest expense related to the 2027 Term Loans: Three Months Ended March 31, (in thousands) 2024 2023 Contractual interest $ 8,747 $ 8,145 Amortization of debt discount and debt issuance costs 972 332 Total interest expense $ 9,719 $ 8,477 |
1.5% Convertible Senior Subordinated Notes due 2026 | |
Debt Instrument | |
Schedule of Components of Interest Expense | The following table presents the components of interest expense related to the 2026 Convertible Notes: Three Months Ended March 31, (in thousands) 2024 2023 Stated coupon interest $ 863 $ 863 Amortization of debt discount and debt issuance costs 332 326 Total interest expense $ 1,195 $ 1,189 |
Schedule of Future Payments on Debt | Year ending December 31, (in thousands) Remainder of 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 (2,780) Net carrying amount of 2026 Convertible Notes $ 227,220 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Commitments and Contingencies. | |
Schedule of Non-cancelable Contractual Obligations | Year ending December 31, (in thousands) 2024 $ 30,609 2025 32,013 2026 1,410 Total obligations $ 64,032 |
Stockholders' Deficit (Tables)
Stockholders' Deficit (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Stockholders' Deficit | |
Schedule of Settlements Under the ATM Offering | Three Months Ended March 31, (in thousands, except share and per share data) 2024 2023 Number of common stock shares sold during the period 650,005 1,131,450 Weighted-average price per share $ 2.44 $ 6.54 Gross proceeds $ 1,589 $ 7,401 Less commissions and fees (40) (185) Net proceeds after commissions and fees $ 1,549 $ 7,216 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Employee And Nonemployee Stock Option Restricted Stock Units | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs | |
Schedule of Stock-Based Compensation Expense | Three Months Ended March 31, (in thousands) 2024 2023 Cost of goods sold (1) $ 248 $ 125 Research and development 2,194 5,461 Selling, general and administrative 4,877 6,696 Stock-based compensation expense $ 7,319 $ 12,282 Stock-based compensation expense capitalized into inventory $ 394 $ 131 |
Net Income (Loss) Per Share (Ta
Net Income (Loss) Per Share (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Net Income (Loss) Per Share | |
Computation of Basic and Diluted Net Income Per Share | Three Months Ended March 31, (in thousands, except share and per share data) 2024 2023 Basic net income (loss) per share Numerator: Net income (loss) $ 102,875 $ (75,729) Denominator: Weighted-average common shares outstanding 112,749,306 79,268,853 Basic net income (loss) per share $ 0.91 $ (0.96) Diluted net income (loss) per share Numerator: Net income (loss) $ 102,875 $ (75,729) Add interest expense on convertible notes, net of tax 1,195 — Numerator for diluted net income (loss) per share $ 104,070 $ (75,729) Denominator: Denominator for basic net income (loss) per share 112,749,306 79,268,853 Add effect of potential dilutive securities: Stock options, including shares subject to ESPP 406,217 — Restricted stock units 432,296 — Shares issuable upon conversion of convertible notes 11,942,152 — Denominator for diluted net income (loss) income per share 125,529,971 79,268,853 Diluted net income (loss) per share $ 0.83 $ (0.96) |
Schedule of Outstanding Dilutive Potential Shares Excluded from Calculation of Diluted Net Income (loss) Per Share | The following outstanding dilutive potential shares were excluded from the calculation of diluted net income (loss) per share due to their anti-dilutive effect: Three Months Ended March 31, 2024 2023 Stock options, including shares subject to ESPP 26,109,011 23,996,096 Restricted stock units 1,066,705 2,586,168 Shares issuable upon conversion of 2026 Convertible Notes — 11,942,152 Total 27,175,716 38,524,416 |
Organization and Summary of S_4
Organization and Summary of Significant Accounting Policies - Organization (Details) $ in Millions | 1 Months Ended | ||||
May 08, 2024 USD ($) | Apr. 01, 2024 USD ($) | Mar. 01, 2024 USD ($) | Apr. 30, 2024 USD ($) | Mar. 31, 2024 product | |
Business Acquisition [Line Items] | |||||
Cash consideration | $ 170 | ||||
Product pipeline, number of product candidates | product | 3 | ||||
Disposal Group, Including Discontinued Operation, Additional Consideration for Product Inventory and Prepaid Manufacturing Assets | 17.8 | ||||
2027 Term Loans | Subsequent Event | |||||
Business Acquisition [Line Items] | |||||
Principal Amount | $ 250 | ||||
Outstanding amount paid off | $ 75 | $ 175 | $ 175 | ||
Coherus Ophthalmology LLC | CIMERLI Disposition Transaction | |||||
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 | Mar. 31, 2024 | Dec. 31, 2023 | Mar. 31, 2023 | Dec. 31, 2022 |
Organization and Summary of Significant Accounting Policies | ||||
Cash and cash equivalents | $ 259,775 | $ 102,891 | $ 16,145 | $ 63,547 |
Restricted cash | 452 | 452 | 440 | 440 |
Total cash, cash equivalents and restricted cash | $ 260,227 | $ 103,343 | $ 16,585 | $ 63,987 |
Revenue - Net Revenue (Details)
Revenue - Net Revenue (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Revenue | ||
Net revenue | $ 77,063 | $ 32,436 |
Total net product revenue | ||
Revenue | ||
Net revenue | 76,743 | 32,353 |
UDENYCA | ||
Revenue | ||
Net revenue | 42,667 | 26,179 |
CIMERLI | ||
Revenue | ||
Net revenue | 28,194 | 6,174 |
YUSIMRY | ||
Revenue | ||
Net revenue | 3,894 | |
LOQTORZI | ||
Revenue | ||
Net revenue | 1,988 | |
Other | ||
Revenue | ||
Net revenue | $ 320 | $ 83 |
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 | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
McKesson | ||
Concentration Risk | ||
Percentage of total gross revenue | 42% | 35% |
Cencora (previously known as AmeriSource-Bergen Corporation) | ||
Concentration Risk | ||
Percentage of total gross revenue | 42% | 43% |
Cardinal | ||
Concentration Risk | ||
Percentage of total gross revenue | 14% | 21% |
Revenue - Activities and Ending
Revenue - Activities and Ending Reserve Balances for Each Significant Category of Discounts and Allowances (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Accounts Notes And Loans Receivable | ||
Activities and reserve balance, beginning balance | $ 244,885 | $ 100,503 |
Provision related to sales made in: | ||
Current period | 322,410 | 121,509 |
Prior period - increase (decrease) | 1,305 | 390 |
Payments and customer credits issued | (344,035) | (131,968) |
Activities and reserve balance, ending balance | 224,565 | 90,434 |
Chargebacks and Discounts for Prompt Payment | ||
Accounts Notes And Loans Receivable | ||
Activities and reserve balance, beginning balance | 73,953 | 42,677 |
Provision related to sales made in: | ||
Current period | 223,619 | 93,906 |
Prior period - increase (decrease) | (504) | (738) |
Payments and customer credits issued | (228,278) | (101,108) |
Activities and reserve balance, ending balance | 68,790 | 34,737 |
Rebates | ||
Accounts Notes And Loans Receivable | ||
Activities and reserve balance, beginning balance | 121,137 | 38,713 |
Provision related to sales made in: | ||
Current period | 56,432 | 13,000 |
Prior period - increase (decrease) | 1,399 | (701) |
Payments and customer credits issued | (74,958) | (14,243) |
Activities and reserve balance, ending balance | 104,010 | 36,769 |
Other Fees, Co-pay Assistance and Returns | ||
Accounts Notes And Loans Receivable | ||
Activities and reserve balance, beginning balance | 49,795 | 19,113 |
Provision related to sales made in: | ||
Current period | 42,359 | 14,603 |
Prior period - increase (decrease) | 410 | 1,829 |
Payments and customer credits issued | (40,799) | (16,617) |
Activities and reserve balance, ending balance | $ 51,765 | $ 18,928 |
Fair Value Measurements - Finan
Fair Value Measurements - Financial Assets Measured on a Recurring Basis (Details) - Fair Value Measurements Recurring Basis - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Financial assets measured at fair value on a recurring basis | ||
Total financial assets | $ 259,845 | $ 104,940 |
Contingent consideration | 632 | |
Level 1 | ||
Financial assets measured at fair value on a recurring basis | ||
Total financial assets | 259,413 | 96,648 |
Level 2 | ||
Financial assets measured at fair value on a recurring basis | ||
Total financial assets | 7,667 | |
Level 3 | ||
Financial assets measured at fair value on a recurring basis | ||
Total financial assets | 432 | 625 |
Contingent consideration | 632 | |
U.S. government agency securities | ||
Financial assets measured at fair value on a recurring basis | ||
Total financial assets | 5,195 | |
U.S. government agency securities | Level 1 | ||
Financial assets measured at fair value on a recurring basis | ||
Total financial assets | 5,195 | |
U.S. treasury securities | ||
Financial assets measured at fair value on a recurring basis | ||
Total financial assets | 2,993 | |
U.S. treasury securities | Level 1 | ||
Financial assets measured at fair value on a recurring basis | ||
Total financial assets | 2,993 | |
Commercial paper and corporate notes | ||
Financial assets measured at fair value on a recurring basis | ||
Total financial assets | 6,669 | |
Commercial paper and corporate notes | Contingent Consideration | ||
Financial assets measured at fair value on a recurring basis | ||
Total financial assets | 4,472 | |
Commercial paper and corporate notes | Level 2 | ||
Financial assets measured at fair value on a recurring basis | ||
Total financial assets | 6,669 | |
Commercial paper and corporate notes | Level 3 | Contingent Consideration | ||
Financial assets measured at fair value on a recurring basis | ||
Total financial assets | 4,472 | |
Money market funds | ||
Financial assets measured at fair value on a recurring basis | ||
Total financial assets | 259,413 | 89,458 |
Money market funds | Level 1 | ||
Financial assets measured at fair value on a recurring basis | ||
Total financial assets | 259,413 | 88,460 |
Money market funds | Level 2 | ||
Financial assets measured at fair value on a recurring basis | ||
Total financial assets | 998 | |
Prepaid financial instrument in Prepaid manufacturing | ||
Financial assets measured at fair value on a recurring basis | ||
Total financial assets | 432 | 625 |
Prepaid financial instrument in Prepaid manufacturing | Level 3 | ||
Financial assets measured at fair value on a recurring basis | ||
Total financial assets | $ 432 | $ 625 |
Fair Value Measurements - Cost,
Fair Value Measurements - Cost, Unrealized Gains or Losses, and Fair Value by Investment Type (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Cost, Unrealized Gains or Losses, and Fair Value by Investment | ||
Cost | $ 259,413 | $ 104,324 |
Unrealized Gain | 2 | |
Unrealized (Loss) | (11) | |
Fair Value | 259,413 | 104,315 |
Money market funds | ||
Cost, Unrealized Gains or Losses, and Fair Value by Investment | ||
Cost | 259,413 | 79,484 |
Fair Value | $ 259,413 | 79,484 |
U.S. government agency securities | ||
Cost, Unrealized Gains or Losses, and Fair Value by Investment | ||
Cost | 5,200 | |
Unrealized (Loss) | (5) | |
Fair Value | 5,195 | |
U.S. treasury securities | ||
Cost, Unrealized Gains or Losses, and Fair Value by Investment | ||
Cost | 11,967 | |
Unrealized Gain | 2 | |
Fair Value | 11,969 | |
Commercial paper and corporate notes | ||
Cost, Unrealized Gains or Losses, and Fair Value by Investment | ||
Cost | 7,673 | |
Unrealized (Loss) | (6) | |
Fair Value | $ 7,667 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) - USD ($) | 1 Months Ended | 3 Months Ended | |||
May 08, 2024 | Apr. 01, 2024 | Apr. 30, 2024 | Mar. 31, 2024 | Dec. 31, 2023 | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||||
Net impairment charge | $ 6,772,000 | ||||
Contingent consideration, current | $ 3,300,000 | ||||
Finite-lived assets, net of accumulated amortization of $812 and $639, as of March 31, 2024 and December 31, 2023, respectively | 28,245,000 | 41,871,000 | |||
Accumulated amortization | 812,000 | 639,000 | |||
Contingent consideration, non-current | 632,000 | $ 1,172,000 | |||
2027 Term Loans | Subsequent Event | |||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||||
Outstanding amount paid off | $ 75,000,000 | $ 175,000,000 | $ 175,000,000 | ||
Principal Amount | $ 250,000,000 | ||||
Surface Acquisition | |||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||||
Contingent consideration, current | 0 | ||||
Contingent consideration, current | 0 | ||||
Contingent consideration, non-current | 500,000 | ||||
Fair value of the contingent consideration | 3,800,000 | ||||
Out-license - Novartis Institutes | |||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||||
Impairment charge | 10,600,000 | ||||
Out-license - Novartis Institutes | Surface Acquisition | |||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||||
Impairment charge | 10,600,000 | ||||
Net impairment charge | $ 6,800,000 | ||||
Impairment, Intangible Asset, Finite-Lived, Statement of Income or Comprehensive Income [Extensible Enumeration] | Selling General And Administrative Expense |
Inventory - Components (Details
Inventory - Components (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Inventory | ||
Raw materials | $ 13,941 | $ 12,975 |
Work in process | 90,400 | 82,588 |
Finished goods | 23,282 | 34,537 |
Total | $ 127,623 | $ 130,100 |
Inventory - Balance Sheet Class
Inventory - Balance Sheet Classifications (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Inventory | ||
Inventory | $ 61,978 | $ 62,605 |
Inventory, non-current | 65,645 | 67,495 |
Total | $ 127,623 | $ 130,100 |
Inventory - Additional Informat
Inventory - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | |
Inventory | |||
Inventory write-downs | $ 2,481 | $ 3,241 | |
Prepayment made for manufacturing services | 7,498 | $ 23,657 | |
Prepayments made to a CMO for manufacturing services for UDENYCA | 3,800 | 12,600 | |
Prepayments made to a CMO For Other Research And Development Pipeline Program | 3,700 | 11,100 | |
Research And Development Expense | 28,470 | $ 34,154 | |
YUSIMRY | |||
Inventory | |||
Certain firm purchase commitments | 20,500 | ||
YUSIMRY | Cost of Goods Sold | |||
Inventory | |||
Inventory write-downs | 47,000 | ||
YUSIMRY | Accrued and other current liabilities | |||
Inventory | |||
Certain firm purchase commitments, Short-term | 11,500 | ||
Purchase commitments remaining amount | $ 8,600 | ||
YUSIMRY | other liabilities, non-current | |||
Inventory | |||
Certain firm purchase commitments, Long-term | 9,000 | ||
CIMERLI | |||
Inventory | |||
Payment related to sale transaction | 6,400 | ||
CIMERLI | Cost of Goods Sold | |||
Inventory | |||
Inventory write-downs | $ 16,400 |
Balance Sheet Components - Sche
Balance Sheet Components - Schedule of Property and Equipment, Net (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Property and Equipment, Net | ||
Total property and equipment | $ 24,786 | $ 25,770 |
Accumulated depreciation and amortization | (20,598) | (20,651) |
Property and equipment, net | 4,188 | 5,119 |
Machinery and equipment | ||
Property and Equipment, Net | ||
Total property and equipment | 13,124 | 13,124 |
Computer equipment and software | ||
Property and Equipment, Net | ||
Total property and equipment | 3,566 | 3,546 |
Furniture and fixtures | ||
Property and Equipment, Net | ||
Total property and equipment | 1,055 | 1,055 |
Leasehold improvements | ||
Property and Equipment, Net | ||
Total property and equipment | 5,751 | 5,751 |
Finance lease right of use assets | ||
Property and Equipment, Net | ||
Total property and equipment | $ 1,290 | $ 2,294 |
Balance Sheet Components - Addi
Balance Sheet Components - Additional Information (Details) - USD ($) $ in Millions | 3 Months Ended | |||
Mar. 01, 2024 | Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | |
Property and Equipment, Net | ||||
Depreciation and amortization expense related to property and equipment, net | $ 0.6 | $ 0.9 | ||
Software implementation costs | 3.2 | $ 3.2 | ||
Goodwill, Written off | $ 0.9 | |||
Out-license - Novartis Institutes | ||||
Property and Equipment, Net | ||||
Impairment of Intangible Assets, Finite-lived | $ 10.6 |
Balance Sheet Components - Inta
Balance Sheet Components - Intangible Assets, Net (Details) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 01, 2024 | Mar. 31, 2024 | Dec. 31, 2023 | |
Balance Sheet Components | |||
Finite-lived assets, net of accumulated amortization of $812 and $639, as of March 31, 2024 and December 31, 2023, respectively | $ 28,245 | $ 41,871 | |
Accumulated amortization | 812 | 639 | |
Indefinite-lived assets - IPR&DIndefinite-lived assets - in-process research and development | 28,859 | 28,859 | |
Goodwill | 943 | ||
Total Intangible assets, net | 57,104 | $ 71,673 | |
Expected amortization expense for the remaining finite-lived assets for each of the five succeeding fiscal years | $ 2,100 | $ 2,800 |
Balance Sheet Components - Accr
Balance Sheet Components - Accrued and Other Current Liabilities (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Balance Sheet Components | ||
Accrued commercial and research and development manufacturing | $ 37,283 | $ 23,470 |
Accrued co-development costs and milestone payments | 25,000 | 26,812 |
Accrued royalties | 35,342 | 42,031 |
Accrued other | 16,271 | 7,628 |
Lease liabilities, current | 1,811 | 2,145 |
Contingent consideration, current | 3,300 | |
Total Accrued and other current liabilities | $ 115,707 | $ 105,386 |
Balance Sheet Components - Othe
Balance Sheet Components - Other Liabilities, Non-current (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Balance Sheet Components | ||
Contingent consideration, non-current | $ 632 | $ 1,172 |
Deferred tax liability | 1,102 | 1,102 |
Other | 1,000 | 10,287 |
Total Other liabilities, non-current | $ 2,734 | $ 12,561 |
Acquisition and Disposition -Ad
Acquisition and Disposition -Additional Information (Details) $ / shares in Units, $ in Thousands | 3 Months Ended | ||||
Sep. 08, 2023 USD ($) item $ / shares shares | Mar. 31, 2024 USD ($) | Mar. 31, 2023 USD ($) | Mar. 01, 2024 USD ($) | Dec. 31, 2023 USD ($) | |
Surface Acquisition | |||||
Cash consideration | $ 170,000 | ||||
Additional consideration | 17,800 | ||||
Pretax profit (loss) | $ 102,875 | $ (75,729) | |||
Income under TSA | 300 | ||||
TSA receivables, net (Note 6) | 32,194 | ||||
TSA payables and other accrued liabilities | 30,770 | ||||
Goodwill | $ 943 | ||||
Net impairment charge | 6,772 | ||||
Finite-lived assets, net of accumulated amortization of $812 and $639, as of March 31, 2024 and December 31, 2023, respectively | 28,245 | 41,871 | |||
Contingent consideration, current | $ 3,300 | ||||
Out-license - Novartis Institutes | |||||
Surface Acquisition | |||||
Impairment charge | 10,600 | ||||
CIMERLI Ophthalmology Franchise [Member] | Disposal Group, Disposed of by Sale, Not Discontinued Operations [Member] | |||||
Surface Acquisition | |||||
Cash consideration | 187,800 | 170,000 | |||
Additional consideration | $ 17,800 | ||||
Gain on sale transaction | 153,600 | ||||
Retention bonus | 11,100 | ||||
Pretax profit (loss) | 7,400 | $ (3,900) | |||
Acquisition related costs | 7,200 | ||||
Surface Acquisition | |||||
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 | ||||
Goodwill | $ 0 | ||||
Business Combination, Number of Out Licensed Partnership Program | item | 2 | ||||
Fair value of the contingent consideration | 3,800 | ||||
Contingent consideration, current | 0 | ||||
Surface Acquisition | Out-license - Novartis Institutes | |||||
Surface Acquisition | |||||
Net impairment charge | $ 6,800 | ||||
Impairment, Intangible Asset, Finite-Lived, Statement of Income or Comprehensive Income [Extensible Enumeration] | Selling General And Administrative Expense | ||||
Impairment charge | $ 10,600 | ||||
Impairment, Intangible Asset, Finite-Lived, Statement of Income or Comprehensive Income [Extensible Enumeration] | Selling General And Administrative Expense | ||||
Surface Acquisition | Surface GSK Agreement | |||||
Surface Acquisition | |||||
Milestone and royalty based CVR payments (as percent) | 70% | ||||
Surface Acquisition | Surface's SRF114 proprietary drug product candidate | |||||
Surface Acquisition | |||||
Upfront payment based CVR payments (as percent) | 25% | ||||
Surface Acquisition | Surface's SRF388 proprietary drug product candidate | |||||
Surface Acquisition | |||||
Upfront payment based CVR payments (as percent) | 50% |
Acquisition and Disposition - E
Acquisition and Disposition - Estimated fair value of the net assets acquired (Details) - Surface Acquisition $ 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 |
Acquisition and Disposition - T
Acquisition and Disposition - The amount allocated to identifiable intangible assets (Details) - Surface Acquisition $ 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 |
Collaborations and Other Arra_2
Collaborations and Other Arrangements (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | ||||||||||
Mar. 21, 2021 USD ($) | Feb. 01, 2021 USD ($) item | Mar. 31, 2024 USD ($) | Mar. 31, 2022 USD ($) | Dec. 31, 2020 USD ($) | Oct. 31, 2018 USD ($) item | Jan. 31, 2016 USD ($) | Mar. 31, 2024 USD ($) | Mar. 31, 2023 USD ($) | Mar. 28, 2024 $ / shares | Dec. 31, 2023 USD ($) | Apr. 14, 2020 $ / shares | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions | ||||||||||||
License Agreement Fee | $ 35,000 | |||||||||||
Research and development | $ 28,470 | $ 34,154 | ||||||||||
Share Price | $ / shares | $ 2.39 | $ 14.82 | ||||||||||
Royalties due | $ 32,700 | 32,700 | $ 38,400 | |||||||||
Milestone payments, amount | 12,500 | |||||||||||
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 | |||||||||||
Collaboration Agreement | ||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | ||||||||||||
License Agreement Fee | $ 35,000 | |||||||||||
Collaboration Agreement | Anti-TIGIT Antibody and IL-2 cytokine | ||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | ||||||||||||
Collaboration Agreement , Maximum Payments On Attainment Of Certain Sales Thresholds For Each Option Program | 170,000 | |||||||||||
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% | |||||||||||
Maximum number of antibodies under for research option | item | 10 | |||||||||||
Minimum Number of Antibodies under Commercialization option | item | 20 | |||||||||||
Novartis Agreement | ||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | ||||||||||||
Potential development milestones | $ 325,000 | |||||||||||
Sales milestones | $ 200,000 | |||||||||||
GSK Agreement | ||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | ||||||||||||
Term of agreement | 10 years | |||||||||||
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 | ||||||||||||
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 | |||||||||||
Maximum paid amount for co-development activities (per licensed compound) | $ 25,000 | |||||||||||
Research and development | 2,100 | |||||||||||
Undisclosed preclinical | item | 2 | |||||||||||
Decrease in Research and Development Expenses for Release of Certain Liabilities | 4,800 | |||||||||||
Junshi Biosciences | Intangible assets, net and accrued and other current liabilities | ||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | ||||||||||||
Accrued milestone payment | 25,000 | 25,000 | ||||||||||
Junshi Biosciences | Accrued and other current liabilities | ||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | ||||||||||||
Co-development, regulatory and technology transfer costs | 25,000 | 25,000 | ||||||||||
Junshi Biosciences | Accounts payable | ||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | ||||||||||||
Co-development, regulatory and technology transfer costs | $ 400 | $ 400 | ||||||||||
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 |
Debt Obligations - Summary of D
Debt Obligations - Summary of Debt Obligations (Details) - Level 2 - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
2027 Term Loans | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Principal amount | $ 250,000 | $ 250,000 |
Less unamortized debt discount and debt issuance costs | (2,548) | (3,519) |
Net carrying amount | 247,452 | 246,481 |
Estimated Fair Value | 247,452 | 246,481 |
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 |
Less unamortized debt discount and debt issuance costs | (2,780) | (3,112) |
Net carrying amount | 227,220 | 226,888 |
Estimated Fair Value | $ 142,888 | $ 150,155 |
Debt Obligations - 2027 Term Lo
Debt Obligations - 2027 Term Loan - Narrative (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | ||||||||
May 08, 2024 USD ($) | Apr. 01, 2024 USD ($) | Feb. 05, 2024 USD ($) | Apr. 30, 2024 USD ($) | Jan. 31, 2022 USD ($) item | Mar. 31, 2024 USD ($) | Mar. 31, 2023 USD ($) | Sep. 14, 2022 USD ($) | Jan. 05, 2022 USD ($) tranche | Apr. 30, 2020 USD ($) | |
Debt Instrument [Line Items] | ||||||||||
Debt partial prepayment to be Made | $ 175,000 | |||||||||
Minimum net sales convenant level agreed to be maintained over past year | 125,000 | |||||||||
2027 Term Loans | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Interest rate | 13.84% | |||||||||
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 | |||||||||
Quarterly payments | item | 5 | |||||||||
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 | |||||||||
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 | Additional facility amount | BioPharma Credit Investments V GP LLC | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Principal amount | $ 100,000 | |||||||||
2027 Term Loans | Starting April 1, 2023 | BioPharma Credit Investments V GP LLC | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Stated interest rate | 8.25% | |||||||||
2027 Term Loans | Subsequent Event | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Principal amount | $ 250,000 | |||||||||
Net carrying value | $ 75,000 | |||||||||
Partial prepayment of principal | 175,000 | |||||||||
Prepayment fees for partial debt repayment | 3,500 | 6,800 | ||||||||
Outstanding amount paid off | $ 75,000 | $ 175,000 | $ 175,000 | |||||||
Tranche A Loan, funded January 5, 2022 | BioPharma Credit Investments V GP LLC | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Principal amount | $ 100,000 | |||||||||
Tranche B Loan, funded on March 31, 2022 | BioPharma Credit Investments V GP LLC | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Principal amount | $ 100,000 | |||||||||
Tranche C Loan, not funded between April 1, 2022 and March 17, 2023 | BioPharma Credit Investments V GP LLC | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Principal amount | 50,000 | |||||||||
Tranche D Loan, funded on September 14, 2022 | BioPharma Credit Investments V GP LLC | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Principal amount | $ 50,000 | |||||||||
1.5% Convertible Senior Subordinated Notes due 2026 | Convertible Notes | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Principal amount | $ 230,000 | |||||||||
Net carrying value | $ 227,220 | |||||||||
Stated interest rate | 1.50% | |||||||||
Remaining unamortized debt discount and debt offering costs | $ 2,780 | |||||||||
Effective interest rate | 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 | |||||||||
Tranches A, B and D | BioPharma Credit Investments V GP LLC | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Remaining unamortized debt discount and debt offering costs | $ 2,500 | |||||||||
Remaining term | 2 years 9 months 18 days |
Debt Obligations - 2027 Term _2
Debt Obligations - 2027 Term Loans, Components of Interest Expense (Details) - 2027 Term Loans - BioPharma Credit Investments V GP LLC - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Debt Instrument [Line Items] | ||
Contractual interest | $ 8,747 | $ 8,145 |
Amortization of debt discount and debt issuance costs | 972 | 332 |
Total Interest expense | $ 9,719 | $ 8,477 |
Debt Obligations - 2029 Term Lo
Debt Obligations - 2029 Term Loan - Narrative (Details) - USD ($) $ in Thousands | 3 Months Ended | |||||
Mar. 31, 2024 | May 08, 2024 | Apr. 01, 2024 | Dec. 31, 2023 | Mar. 31, 2023 | Dec. 31, 2022 | |
Debt Instrument [Line Items] | ||||||
Cash and cash equivalents | $ 259,775 | $ 102,891 | $ 16,145 | $ 63,547 | ||
2027 Term Loans | Subsequent Event | ||||||
Debt Instrument [Line Items] | ||||||
Principal Amount | $ 250,000 | |||||
2027 Term Loans | SOFR | ||||||
Debt Instrument [Line Items] | ||||||
Spread on variable rate | 1% | |||||
Ankura Trust Company, LLC | 2029 Term Loans | Subsequent Event | ||||||
Debt Instrument [Line Items] | ||||||
Principal Amount | $ 38,700 | |||||
Stated interest rate | 8% |
Debt Obligations - 2027 Term _3
Debt Obligations - 2027 Term Loan Future Payments (Details) - 2027 Term Loans - USD ($) $ in Millions | 1 Months Ended | 3 Months Ended | ||
May 08, 2024 | Apr. 01, 2024 | Apr. 30, 2024 | Mar. 31, 2024 | |
Debt Instrument [Line Items] | ||||
Interest rate | 13.84% | |||
Subsequent Event | ||||
Debt Instrument [Line Items] | ||||
Net carrying amount | $ 75 | |||
Repayment of 2025 Term Loan, premiums and exit fees | $ (75) | $ (175) | $ (175) |
Debt Obligations - Convertible
Debt Obligations - Convertible Senior Subordinated Notes due 2026 - Narrative (Details) | 1 Months Ended | 3 Months Ended | ||
Apr. 30, 2020 USD ($) $ / shares shares | Mar. 31, 2024 USD ($) | Mar. 28, 2024 $ / shares | Apr. 14, 2020 $ / shares | |
Debt Instrument | ||||
Closing stock, price per share | $ / shares | $ 2.39 | $ 14.82 | ||
1.5% Convertible Senior Subordinated Notes due 2026 | ||||
Debt Instrument | ||||
Number of events in default | 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 March 31, 2024, 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 | $ 2,780,000 | |||
Effective interest rate | 2.10% | |||
Convertible Notes | 1.5% Convertible Senior Subordinated Notes due 2026 | Scenario, Plan | ||||
Debt Instrument | ||||
Convertible notes, converted amount | $ 28,500,000 |
Debt Obligations - Capped Call
Debt Obligations - Capped Call Transactions - Narrative (Details) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | ||
Apr. 30, 2020 | Mar. 28, 2024 | Apr. 14, 2020 | |
Option Indexed to Issuer's Equity [Line Items] | |||
Closing stock, price per share | $ 2.39 | $ 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% | ||
Closing stock, price per share | $ 14.82 |
Debt Obligations - 2026 Convert
Debt Obligations - 2026 Convertible Notes Interest Expense Components (Details) - 1.5% Convertible Senior Subordinated Notes due 2026 - Convertible Notes - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Debt Instrument | ||
Stated coupon interest | $ 863 | $ 863 |
Amortization of debt discount and debt issuance costs | 332 | 326 |
Total Interest expense | $ 1,195 | $ 1,189 |
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 | Mar. 31, 2024 USD ($) |
Debt Instrument | |
Remainder of 2024 - interest only | $ 3,450 |
2026 - interest only | 3,450 |
2027 - 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 | (2,780) |
Net carrying amount | $ 227,220 |
Commitments and Contingencies -
Commitments and Contingencies - Schedule of Non-Cancelable Contractual Obligations (Details) $ in Thousands | Mar. 31, 2024 USD ($) |
Commitments and Contingencies. | |
2024 | $ 30,609 |
2025 | 32,013 |
2026 | 1,410 |
Total obligations | $ 64,032 |
Commitments and Contingencies_2
Commitments and Contingencies - Additional Information (Details) - USD ($) $ in Millions | 1 Months Ended | ||
Apr. 30, 2022 | Mar. 31, 2024 | Dec. 31, 2023 | |
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 | $ 6.4 |
Stockholders' Deficit (Details)
Stockholders' Deficit (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | ||||||||
Sep. 11, 2023 | May 18, 2023 | May 16, 2023 | Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | May 15, 2023 | Nov. 17, 2022 | Nov. 08, 2022 | |
Stockholders' Deficit | |||||||||
Common stock, par value | $ 0.0001 | $ 0.0001 | |||||||
Public Offering | |||||||||
Stockholders' Deficit | |||||||||
Common stock, shares issued and sold | 13,529,411 | 11,764,706 | |||||||
Common stock, par value | $ 0.0001 | ||||||||
Net proceeds, after deducting the Underwriters' discounts and commissions and offering expenses | $ 53,600 | ||||||||
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 | 650,005 | 1,131,450 | |||||||
Aggregate offering price | $ 1,507 | $ 7,059 | |||||||
Shares Offering, Aggregate Amount, Decrease | $ 86,200 | ||||||||
Increase in Amount of Shares To be Issued and Sold | $ 28,700 | ||||||||
Common stock, net proceeds | 1,549 | 7,216 | |||||||
Gross proceeds | 1,589 | 7,401 | |||||||
Less commissions and fees | (40) | (185) | |||||||
Net proceeds after commissions and fees | 1,549 | $ 7,216 | |||||||
Common stock remaining available for sales under the ATM Offering | $ 64,900 | ||||||||
At The Market Offering. | Weighted Average | |||||||||
Stockholders' Deficit | |||||||||
Weighted-average price per share | $ 2.44 | $ 6.54 | |||||||
At The Market Offering. | Maximum | |||||||||
Stockholders' Deficit | |||||||||
Shares Offering, Aggregate Amount | $ 92,500 | $ 63,800 | $ 150,000 | ||||||
Underwriters' Option to Purchase Additional Shares | |||||||||
Stockholders' Deficit | |||||||||
Common stock, shares issued and sold | 1,764,705 | ||||||||
Share price | $ 3.995 | ||||||||
Term of share offering | 30 days |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock-Based Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs | ||
Stock-based compensation expense | $ 7,319 | $ 12,282 |
Stock-based compensation expense capitalized into inventory | 394 | 131 |
Cost of Goods Sold | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs | ||
Stock-based compensation expense | 248 | 125 |
Research and development | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs | ||
Stock-based compensation expense | 2,194 | 5,461 |
Selling, General and Administrative Expenses | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs | ||
Stock-based compensation expense | $ 4,877 | $ 6,696 |
Net Income (Loss) Per Share - C
Net Income (Loss) Per Share - Computation of Basic and Diluted Net Income Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Numerator: | ||
Net Income (Loss) | $ 102,875 | $ (75,729) |
Denominator: | ||
Weighted-average common shares outstanding - Basic | 112,749,306 | 79,268,853 |
Weighted-average common shares outstanding - Diluted | 125,529,971 | 79,268,853 |
Basic net income (loss) per share | $ 0.91 | $ (0.96) |
Diluted net income (loss) per share | $ 0.83 | $ (0.96) |
Numerator: | ||
Add interest expense on 2026 Convertible Notes, net of tax | $ 1,195 | |
Numerator for diluted net income (loss) per share | $ 104,070 | $ (75,729) |
Add effect of potential dilutive securities: | ||
Stock options, including shares subject to ESPP | 406,217 | |
Restricted stock units | 432,296 | |
Shares issuable upon conversion of convertible notes | 11,942,152 | |
Denominator for diluted net income (loss) income per share | 125,529,971 | 79,268,853 |
Net Income (Loss) Per Share - O
Net Income (Loss) Per Share - Outstanding Dilutive Potential Shares Excluded from Calculation of Diluted Net Income (loss) Per Share (Details) - shares | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Antidilutive securities excluded from computation of EPS | ||
Antidilutive securities excluded from the calculation of diluted net income (loss) per share | 27,175,716 | 38,524,416 |
Stock options, including shares subject to ESPP | ||
Antidilutive securities excluded from computation of EPS | ||
Antidilutive securities excluded from the calculation of diluted net income (loss) per share | 26,109,011 | 23,996,096 |
Restricted stock units | ||
Antidilutive securities excluded from computation of EPS | ||
Antidilutive securities excluded from the calculation of diluted net income (loss) per share | 1,066,705 | 2,586,168 |
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 income (loss) per share | 11,942,152 |
Subsequent Events (Details)
Subsequent Events (Details) - USD ($) $ in Thousands | 3 Months Ended | |||||
May 08, 2024 | Apr. 01, 2024 | Mar. 31, 2024 | Dec. 31, 2023 | Mar. 31, 2023 | Dec. 31, 2022 | |
Subsequent Events | ||||||
Cash and cash equivalents | $ 259,775 | $ 102,891 | $ 16,145 | $ 63,547 | ||
Subsequent Event | ||||||
Subsequent Events | ||||||
Revenue Purchase and Sale Agreement, Purchase price | $ 37,500 | |||||
Purchase price multiplier | 2.25 | |||||
2027 Term Loans | Subsequent Event | ||||||
Subsequent Events | ||||||
Partial prepayment of principal | $ 175,000 | |||||
Principal amount | 250,000 | |||||
Amount outstanding | $ 75,000 | |||||
Prepayment fees for partial debt repayment | $ 3,500 | $ 6,800 | ||||
2027 Term Loans | SOFR | ||||||
Subsequent Events | ||||||
Spread on variable rate | 1% | |||||
2029 Term Loans | Subsequent Event | ||||||
Subsequent Events | ||||||
Default additional rate | 4% | |||||
2029 Term Loans | On or after the first anniversary | Subsequent Event | ||||||
Subsequent Events | ||||||
Prepayment fee | 10% | |||||
2029 Term Loans | After the second anniversary | Subsequent Event | ||||||
Subsequent Events | ||||||
Prepayment fee | 5% | |||||
2029 Term Loans | After the third anniversary | Subsequent Event | ||||||
Subsequent Events | ||||||
Prepayment fee | 0% | |||||
Ankura Trust Company, LLC | 2029 Term Loans | Subsequent Event | ||||||
Subsequent Events | ||||||
Principal amount | $ 38,700 | |||||
Stated interest rate | 8% |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Pay vs Performance Disclosure | ||
Net Income (Loss) | $ 102,875 | $ (75,729) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Mar. 31, 2024 | |
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 |