Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2023 | Apr. 30, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Mar. 31, 2023 | |
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, $0.0001 par value per share | |
Trading Symbol | CHRS | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 80,553,730 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q1 | |
Entity Central Index Key | 0001512762 | |
Amendment Flag | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 16,145 | $ 63,547 |
Investments in marketable securities | 111,944 | 128,134 |
Trade receivables, net | 101,458 | 109,964 |
Inventory | 49,406 | 38,791 |
Prepaid manufacturing | 16,019 | 17,880 |
Other prepaids and current assets | 20,954 | 22,918 |
Total current assets | 315,926 | 381,234 |
Property and equipment, net | 7,724 | 8,754 |
Inventory, non-current | 65,081 | 76,260 |
Goodwill and intangible assets | 5,870 | 5,931 |
Other assets, non-current | 7,825 | 8,668 |
Total assets | 402,426 | 480,847 |
Current liabilities: | ||
Accounts payable | 23,231 | 11,526 |
Accrued rebates, fees and reserves | 55,697 | 54,461 |
Accrued compensation | 12,422 | 22,610 |
Accrued and other current liabilities | 32,057 | 50,097 |
Total current liabilities | 123,407 | 138,694 |
Term loans | 245,718 | 245,483 |
Convertible notes | 225,900 | 225,575 |
Lease liabilities, non-current | 3,806 | 5,046 |
Other liabilities, non-current | 102 | 3,467 |
Total liabilities | 598,933 | 618,265 |
Commitments and contingencies (Note 8) | ||
Stockholders' deficit: | ||
Common stock ($0.0001 par value; shares authorized: 300,000,000; shares issued and outstanding: 80,488,296 and 78,851,516 at March 31, 2023 and December 31, 2022, respectively) | 8 | 8 |
Additional paid-in capital | 1,221,100 | 1,204,431 |
Accumulated other comprehensive loss | (278) | (249) |
Accumulated deficit | (1,417,337) | (1,341,608) |
Total stockholders' deficit | (196,507) | (137,418) |
Total liabilities and stockholders' deficit | $ 402,426 | $ 480,847 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parentheticals) - $ / shares | Mar. 31, 2023 | Dec. 31, 2022 |
Condensed Consolidated Balance Sheets | ||
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 300,000,000 | 300,000,000 |
Common stock, shares issued | 80,488,296 | 78,851,516 |
Common stock, shares outstanding | 80,488,296 | 78,851,516 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Revenue: | ||
Net revenue | $ 32,436 | $ 60,115 |
Costs and expenses: | ||
Cost of goods sold | 16,874 | 9,370 |
Research and development | 34,154 | 82,917 |
Selling, general and administrative | 49,153 | 48,753 |
Total costs and expenses | 100,181 | 141,040 |
Loss from operations | (67,745) | (80,925) |
Interest expense | (9,712) | (8,969) |
Loss on debt extinguishment | (6,222) | |
Other income (expense), net | 1,728 | 32 |
Loss before income taxes | (75,729) | (96,084) |
Net loss | $ (75,729) | $ (96,084) |
Net (loss) income per share: | ||
Basic (In dollar per share) | $ (0.96) | $ (1.24) |
Diluted (In dollar per share) | $ (0.96) | $ (1.24) |
Weighted-average number of shares used in computing basic and diluted net loss per share: | ||
Basic (In shares) | 79,268,853 | 77,253,699 |
Diluted (In shares) | 79,268,853 | 77,253,699 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Condensed Consolidated Statements of Comprehensive Loss | ||
Net loss | $ (75,729) | $ (96,084) |
Other comprehensive loss: | ||
Unrealized loss on available-for-sale securities, net of tax | (29) | |
Foreign currency translation adjustments, net of tax | (2) | |
Comprehensive loss | $ (75,758) | $ (96,086) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders' Equity (Deficit) - USD ($) $ in Thousands | Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive Loss | Accumulated Deficit | Total |
Beginning Balances at Dec. 31, 2021 | $ 7 | $ 1,147,843 | $ (270) | $ (1,049,854) | $ 97,726 |
Beginning Balances (in shares) at Dec. 31, 2021 | 76,930,096 | ||||
Net loss | (96,084) | (96,084) | |||
Issuance of common stock upon exercise of stock options | 544 | 544 | |||
Issuance of common stock upon exercise of stock options (in shares) | 102,632 | ||||
Issuance of common stock upon vesting of RSUs (in shares) | 491,087 | ||||
Stock-based compensation expense | 13,037 | 13,037 | |||
Taxes paid related to net share settlement of RSUs | (2,658) | (2,658) | |||
Taxes paid related to net share settlement of RSUs (in shares) | (185,644) | ||||
Other comprehensive loss, net of tax | (2) | (2) | |||
Ending Balances at Mar. 31, 2022 | $ 7 | 1,158,766 | (272) | (1,145,938) | 12,563 |
Ending Balances (in shares) at Mar. 31, 2022 | 77,338,171 | ||||
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 | 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 RSUs (in shares) | 771,167 | ||||
Stock-based compensation expense | 12,288 | 12,288 | |||
Issuance of common stock under ATM Offering, net of issuance costs | 7,059 | 7,059 | |||
Issuance of common stock under ATM Offering, net of issuance costs (in shares) | 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 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 | 80,488,296 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Operating activities | ||
Net loss | $ (75,729) | $ (96,084) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 949 | 767 |
Stock-based compensation expense | 12,282 | 12,879 |
Inventory write-offs, net | 3,241 | |
Non-cash accretion of discount on marketable securities | (1,339) | |
Non-cash interest expense from amortization of debt discount & issuance costs | 656 | 3,696 |
Option payment to Shanghai Junshi Biosciences Ltd. ("Junshi Biosciences") | 35,000 | |
Loss on debt extinguishment | 6,222 | |
Other non-cash adjustments, net | 554 | 592 |
Changes in operating assets and liabilities: | ||
Trade receivables, net | 8,529 | 5,991 |
Inventory | (2,671) | (2,962) |
Prepaid manufacturing | 1,861 | 248 |
Other prepaid, current and non-current assets | 2,057 | (7,632) |
Accounts payable | 11,739 | 4,757 |
Accrued rebates, fees and reserves | 1,236 | (7,133) |
Accrued compensation | (10,188) | (7,144) |
Accrued and other current and non-current liabilities | (21,909) | (3,242) |
Net cash used in operating activities | (68,732) | (54,045) |
Investing activities | ||
Purchases of property and equipment | (152) | (615) |
Proceeds from disposal of property and equipment | 178 | |
Proceeds from maturities of investments in marketable securities | 17,500 | |
Option payment to Junshi Biosciences | (35,000) | |
Net cash provided by (used in) investing activities | 17,526 | (35,615) |
Financing activities | ||
Proceeds from 2027 Term Loans, net of debt discount & issuance costs | 191,190 | |
Proceeds from issuance of common stock under ATM Offering, net of issuance costs | 6,835 | |
Proceeds from issuance of common stock upon exercise of stock options | 103 | 544 |
Taxes paid related to net share settlement of RSUs | (2,781) | (2,658) |
Repayment of 2022 Convertible Notes and premiums | (109,000) | |
Repayment of 2025 Term Loan, premiums and exit fees | (81,750) | |
Other financing activities | (353) | (181) |
Net cash provided by (used in) financing activities | 3,804 | (1,855) |
Net decrease in cash, cash equivalents and restricted cash | (47,402) | (91,515) |
Cash, cash equivalents and restricted cash at beginning of period | 63,987 | 417,635 |
Cash, cash equivalents and restricted cash at end of period | $ 16,585 | $ 326,120 |
Organization and Significant Ac
Organization and Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2023 | |
Organization and Significant Accounting Policies | |
Organization and Significant Accounting Policies | 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 cancer treatments and commercialization of its portfolio of United States Food and Drug Administration (“FDA”)-approved biosimilars. The Company’s strategy is to build a leading immuno-oncology franchise funded with cash generated through net sales of its diversified portfolio of FDA-approved therapeutics. The Company’s headquarters and laboratories are located in Redwood City, California and in Camarillo, California, respectively. The Company sells UDENYCA® (pegfilgrastim-cbqv) (adalimumab-aqvh), a biosimilar to Humira, (ranibizumab-eqrn) The Company’s product pipeline comprises the following three product candidates: toripalimab, an anti-PD-1 antibody being developed in collaboration with Shanghai Junshi Biosciences Co., Ltd. (“Junshi Biosciences”); CHS-006, an antibody targeting TIGIT being developed in collaboration with Junshi Biosciences; and one wholly-owned preclinical immuno-oncology program, CHS-1000, an antibody targeting ILT4. In May 2022, the Company discontinued development of its bevacizumab (Avastin) biosimilar product candidate in-licensed from Innovent Biologics (Suzhou) Co., Ltd. (“Innovent”). In October 2022, the Company discontinued development of its preclinical immuno-oncology program, CHS-3318, an antibody targeting CCR8. On January 9, 2023, the Company announced that it entered into a binding term sheet (the “Term Sheet”) with Klinge Biopharma GmbH (“Klinge Biopharma”) for the exclusive commercialization rights to FYB203, a biosimilar candidate to Eylea® (aflibercept), in the United States. The parties to the Term Sheet expect to execute the definitive agreements contemplated by the Term Sheet (the “Definitive Agreements”) and complete the transaction in mid-2023. 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, 2022 (the “2022 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 judgements, estimates and assumptions that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosures. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances. These estimates form the basis for making judgments about the carrying values of assets and liabilities when these values are not readily apparent from other sources. Estimates are assessed each period and updated to reflect current information. Accounting estimates and judgements 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: 2023 2022 Cash and cash equivalents $ 63,547 $ 417,195 Restricted cash 440 440 Total cash, cash equivalents and restricted cash $ 63,987 $ 417,635 March 31, At end of period: 2023 2022 Cash and cash equivalents $ 16,145 $ 325,680 Restricted cash 440 440 Total cash, cash equivalents and restricted cash $ 16,585 $ 326,120 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, 2023 and December 31, 2022. Derivative Instruments In January 2023, the Company commenced using derivative contracts (foreign exchange option contracts) for the purpose of economically hedging exposure to changes in currency fluctuations between the U.S. Dollar and the Euro. The Company recognizes all derivatives at fair value in the condensed consolidated balance sheets, and corresponding gains and losses are recognized in other income (expense), net in the condensed consolidated statements of operations. The estimated fair value of derivative financial instruments represents the amount required to enter into similar contracts with similar remaining maturities based on quoted market prices. During the periods presented, the Company did not apply hedge accounting to these instruments (see Note 9). Recent Accounting Pronouncements The Company has reviewed recent accounting pronouncements and concluded they are either not applicable to the business or that no material effect is expected on the condensed consolidated financial statements as a result of future adoption. |
Revenue
Revenue | 3 Months Ended |
Mar. 31, 2023 | |
Revenue | |
Revenue | 2. Revenue The Company initiated sales in the United States of CIMERLI on October 3, 2022. The Company’s net revenue was as follows: Three Months Ended March 31, (in thousands) 2023 2022 Products UDENYCA $ 26,179 $ 60,069 CIMERLI 6,174 — Total net product revenue 32,353 60,069 Other 83 46 Total net revenue $ 32,436 $ 60,115 Gross product revenues by significant customer as a percentage of total gross product revenues were as follows: Three Months Ended March 31, 2023 2022 McKesson Corporation 35 % 39 % AmeriSource-Bergen Corporation 43 % 43 % Cardinal Health, Inc. 21 % 17 % Product Sales Discounts and Allowances The activities and ending reserve balances for each significant category of discounts and allowances, which constitute variable consideration, were as follows: 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 (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 Three Months Ended March 31, 2022 Chargebacks Other Fees, and Discounts Co-pay for Prompt Assistance (in thousands) Payment Rebates and Returns Total Balances at December 31, 2021 $ 29,665 $ 54,004 $ 26,054 $ 109,723 Provision related to sales made in: Current period 105,737 20,269 20,288 146,294 Prior period (1,081) (1,721) (344) (3,146) Payments and customer credits issued (107,625) (24,216) (22,440) (154,281) Balances at March 31, 2022 $ 26,696 $ 48,336 $ 23,558 $ 98,590 Chargebacks and discounts for prompt payment are recorded as a reduction in trade receivables, and the remaining reserve balances are classified as current liabilities in the accompanying unaudited condensed consolidated balance sheets. |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2023 | |
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. There were no transfers between Level 1, Level 2 and Level 3 during the periods presented. 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. Financial assets and liabilities measured at fair value on a recurring basis are summarized as follows: Fair Value Measurements March 31, 2023 (in thousands) Level 1 Level 2 Level 3 Total Financial Assets: Money market funds $ 11,712 $ — $ — $ 11,712 Marketable debt securities: U.S. government agency securities 15,120 — — 15,120 U.S. treasury securities 50,036 — — 50,036 Commercial paper and corporate notes — 46,788 — 46,788 Currency contracts — 44 — 44 Total $ 76,868 $ 46,832 $ — $ 123,700 Financial Liabilities: Currency contracts $ — $ 167 $ — $ 167 Fair Value Measurements December 31, 2022 (in thousands) Level 1 Level 2 Level 3 Total Financial Assets: Money market funds $ 55,060 $ — $ — $ 55,060 Marketable debt securities: U.S. government agency securities 19,964 — — 19,964 U.S. treasury securities 68,418 — — 68,418 Commercial paper and corporate notes — 48,203 — 48,203 Total $ 143,442 $ 48,203 $ — $ 191,645 The cost, unrealized gains or losses, and fair value by investment type are summarized as follows: March 31, 2023 (in thousands) Cost Unrealized Gain Unrealized (Loss) Fair Value Money market funds $ 11,712 $ — $ — $ 11,712 U.S. government agency securities 15,109 13 (2) 15,120 U.S. treasury securities 50,042 3 (9) 50,036 Commercial paper and corporate notes 46,800 — (12) 46,788 Total $ 123,663 $ 16 $ (23) $ 123,656 December 31, 2022 (in thousands) Cost Unrealized Gain Unrealized (Loss) Fair Value Money market funds $ 55,060 $ — $ — $ 55,060 U.S. government agency securities 19,929 35 — 19,964 U.S. treasury securities 68,431 8 (21) 68,418 Commercial paper and corporate notes 48,203 — — 48,203 Total $ 191,623 $ 43 $ (21) $ 191,645 The Company held positions that were in unrealized loss positions as of March 31, 2023, and aggregated gross unrealized losses on available-for-sale debt securities were not material. No impairment was recognized in the first quarter of 2023. As of March 31, 2023, the remaining contractual maturities of available-for-sale securities were less than one year , and the average maturity of investments upon acquisition was approximately 8 months . The accrued interest receivable on available-for-sale marketable securities was immaterial at March 31, 2023 and December 31, 2022, and is included in other prepaid and current assets. There were no investments in marketable securities as of March 31, 2022; thus, no unrealized gain (loss) was recognized as of March 31, 2022. |
Inventory
Inventory | 3 Months Ended |
Mar. 31, 2023 | |
Inventory | |
Inventory | 4. Inventory Inventory consisted of the following: March 31, December 31, (in thousands) 2023 2022 Raw materials $ 13,008 $ 10,262 Work in process 82,206 86,712 Finished goods 19,273 18,077 Total $ 114,487 $ 115,051 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. The Company began capitalizing YUSIMRY inventory in the second quarter of 2022 and had $25.1 million and $23.7 million of such inventory as of March 31, 2023 and December 31, 2022, respectively. 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, 2023 and December 31, 2022, the non-current portion of inventory consisted of raw materials, work in process and a portion of finished goods. The following table presents the inventory balance sheet classifications: March 31, December 31, (in thousands) 2023 2022 Inventory $ 49,406 $ 38,791 Inventory, non-current 65,081 76,260 Total $ 114,487 $ 115,051 Prepaid manufacturing of $16.0 million as of March 31, 2023 includes prepayments of $11.6 million to contract manufacturing organizations (“CMOs”) for manufacturing services for our products, which the Company expects to be converted into inventory within the next twelve months; and prepayments of $4.4 million to various CMOs for research and development pipeline programs. Prepaid manufacturing of $17.9 million as of December 31, 2022 included prepayments of $13.0 million to CMOs for manufacturing services of the Company’s products, which the Company expects to be converted into inventory during 2023; and prepayments of $4.9 million to various CMOs for research and development pipeline programs. |
Balance Sheet Components
Balance Sheet Components | 3 Months Ended |
Mar. 31, 2023 | |
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) 2023 2022 Machinery and equipment $ 13,031 $ 12,944 Computer equipment and software 3,127 3,183 Furniture and fixtures 1,258 1,258 Leasehold improvements 6,234 6,198 Finance lease right of use assets 4,070 4,632 Construction in progress 524 696 Total property and equipment 28,244 28,911 Accumulated depreciation and amortization (20,520) (20,157) Property and equipment, net $ 7,724 $ 8,754 Depreciation and amortization expense related to property and equipment, net was $0.9 million and $0.8 million for the three months ended March 31, 2023 and 2022, respectively. As of March 31, 2023 and December 31, 2022, the net book value of software implementation costs related to hosting arrangements was $3.2 million and $3.5 million, respectively, and the amortization expense was immaterial for all periods presented. Accrued and Other Current Liabilities Accrued and other current liabilities consisted of the following: March 31, December 31, (in thousands) 2023 2022 Accrued commercial and research and development manufacturing $ 9,677 $ 21,774 Accrued co-development costs payable to Junshi Biosciences 3,480 8,356 Lease liabilities, current 4,436 4,318 Accrued other 14,464 15,649 Total Accrued and other current liabilities $ 32,057 $ 50,097 |
Collaborations and Other Arrang
Collaborations and Other Arrangements | 3 Months Ended |
Mar. 31, 2023 | |
Collaborations and Other Arrangements | |
Collaborations and Other Arrangements | 6. Collaborations and Other Arrangements 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 toripalimab, Junshi Biosciences’ anti-PD-1 antibody, in the United States and Canada. Under the terms of the Collaboration Agreement, the Company paid $150.0 million upfront for exclusive rights to toripalimab in the United States and Canada, an option in these territories to Junshi Biosciences’ anti-TIGIT antibody CHS-006, an option in these territories to a next-generation engineered IL-2 cytokine, and certain negotiation rights to two undisclosed preclinical immuno-oncology drug candidates. The Company will have the right to conduct all commercial activities of toripalimab in the United States and Canada. The Company will be obligated to pay Junshi Biosciences a 20% royalty on net sales of toripalimab and up to an aggregate $380.0 million in one-time payments for the achievement of various regulatory and sales milestones. In March 2022, the Company paid $35.0 million for the exercise of its option to license CHS-006. Junshi Biosciences and the Company are jointly developing CHS-006 with each party responsible for the associated development costs as set forth in the Collaboration Agreement. If the Company exercises its remaining option for the IL-2 cytokine, it will be obligated to pay an additional option exercise fee of $35.0 million. Additionally, for each exercised option, the Company will be obligated to pay Junshi Biosciences an 18% royalty on net sales, up to $85.0 million for the achievement of certain regulatory approvals, and up to $170.0 million for the attainment of certain sales thresholds. Under the Collaboration Agreement, the Company retains the right to collaborate in the development of toripalimab and the other licensed compounds, including CHS-006, and will pay for a portion of these co-development activities up to a maximum of $25.0 million per licensed compound per year. Beginning in 2023, the scope of the development plan for toripalimab in the United States has been reduced based on changes approved by the Company and Junshi Biosciences. Additionally, the Company is responsible for certain associated regulatory and technology transfer costs for toripalimab and other licensed compounds and will reimburse Junshi Biosciences for such costs. The licensing transaction and the exercise of the option were accounted for as asset acquisitions under the relevant accounting rules. Research and development expenses recognized for obligations to Junshi Biosciences were $2.1 million for the three months ended March 31, 2023, and $50.1 million, inclusive of the $35.0 million option fee, for the three months ended March 31, 2022. In the condensed consolidated balance sheet as of March 31, 2023, the Company has classified $3.5 million in accrued and other current liabilities and $2.1 million in accounts payable related to the co-development, regulatory and technology transfer costs related to these programs. As of March 31, 2023, the Company did not have any outstanding milestone or royalty payment obligations to Junshi Biosciences. The additional milestone payments, option fee for the IL-2 cytokine and royalties are contingent upon future events and, therefore, will be recorded when it is probable that a milestone will be achieved, option fee will be incurred or when royalties are due. 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. Bioeq will supply to the Company the Bioeq Licensed Products in accordance with terms and conditions specified in the Bioeq License Agreement and a manufacturing and supply agreement to be executed by the parties in accordance therewith. The Bioeq License Agreement’s initial term continues in effect for ten years after the first commercial sale of a Bioeq Licensed Product in the United States, and thereafter renews for an unlimited period of time unless otherwise terminated in accordance with its terms. Bioeq will manufacture and supply the Bioeq Licensed Products to the Company in accordance with terms and conditions specified in the Bioeq License Agreement and a manufacturing and supply agreement between the Company and Bioeq dated September 29, 2022 (the “Bioeq Manufacturing Agreement”). The Bioeq Manufacturing Agreement will remain in force until the first to occur of the following: (1) the termination of the Bioeq License Agreement; (2) the exercise of a right to termination by the Company or Bioeq for a material breach of the other party that is not cured in accordance with the Bioeq Manufacturing Agreement; and (3) the exercise of a right to termination by Bioeq if invoices are not paid in full in accordance with the Bioeq Manufacturing Agreement. Under the Bioeq License Agreement, the Company must use commercially reasonable efforts to develop and obtain regulatory approval of the Bioeq Licensed Products in the United States in accordance with a development and manufacturing plan, and the Company must use commercially reasonable efforts to commercialize the Bioeq Licensed Products in accordance with a commercialization plan. Additionally, the Company must commit certain post-launch resources to the commercialization of the Bioeq Licensed Products for a limited time as specified in the agreement. The Company accounted for the licensing transaction as an asset acquisition under the relevant accounting rules. The Company paid Bioeq an upfront and a milestone payment aggregating to €10 million ($11.1 million), which was recorded as research and development expense in the Company’s consolidated statement of operations in 2019. The terms of the Bioeq License Agreement include an aggregate of up to €12.5 million in additional milestone payments in connection with the achievement of certain development and regulatory milestones with respect to the Bioeq Licensed Products in the United States including a €2.5 million milestone related to the FDA approval of the CIMERLI Section 351(k) BLA that was paid in the fourth quarter of 2022. This was recorded as an intangible asset and is being amortized over ten years. The Company shares a percentage of gross profits on sales of Bioeq Licensed Products in the United States with Bioeq in the low- to mid-fifty percent range. Royalties due to Bioeq were $2.5 million and $2.9 million as of March 31, 2023 and December 31, 2022, respectively. The remaining milestone payments and royalties are contingent upon future events and, therefore, will be recorded when it becomes probable that a milestone will be achieved. Other On January 9, 2023, the Company announced that it entered into the Term Sheet with Klinge Biopharma for the exclusive commercialization rights to FYB203, a biosimilar candidate to Eylea® (aflibercept), in the United States. The parties to the Term Sheet expect to execute the Definitive Agreements contemplated by the Term Sheet and complete the transaction in mid-2023. Under the Term Sheet, the Company will make a total upfront payment of approximately €30 million, comprised of cash and the Company’s common stock, thirty days after the execution of the Definitive Agreements. The Company has also agreed to make other regulatory and launch milestone payments and to make royalty payments based on approximately equal sharing of profits from the sale of FYB203 in consideration for the commercialization rights to FYB203 in the United States. The material terms of the transaction with Klinge Biopharma will be set forth in the Definitive Agreements, which will be included in a subsequent filing by the Company when such Definitive Agreements are executed. |
Debt Obligations
Debt Obligations | 3 Months Ended |
Mar. 31, 2023 | |
Debt Obligations | |
Debt Obligations | 7. Debt Obligations A summary of the Company’s debt obligations, including level within the fair value hierarchy (see Note 3), is as follows: At March 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 $ (4,282) $ 245,718 $ 245,718 Level 2* 2026 Convertible Notes $ 230,000 $ (4,100) $ 225,900 $ 159,358 Level 2** At December 31, 2022 (in thousands) Principal Amount Unamortized Debt Discount and Debt Issuance Costs Net Carrying Value Estimated Fair Value Level Financial Liabilities: 2027 Term Loans $ 250,000 $ (4,517) $ 245,483 $ 245,483 Level 2* 2026 Convertible Notes $ 230,000 $ (4,425) $ 225,575 $ 157,205 Level 2** * The principal amounts outstanding are subject to variable interest rates, which are based on three-month SOFR starting April 1, 2023 plus fixed percentages. Through March 31, 2023, the variable component was based on the three-month LIBOR. Therefore, the Company believes the carrying amount of these obligations approximates fair value. ** 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 Company’s 2026 Convertible Notes is greater than $50.0 million on October 1, 2025. The 2027 Term Loans accrued interest from inception through March 31, 2023 at 8.25% plus three-month LIBOR per annum with a LIBOR floor of 1.0%; and starting April 1, 2023, accrue interest at 8.25% plus the 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 2023 was 13.03%. Interest is payable quarterly in arrears on March 31, June 30, September 30 and December 31 of each year. Repayment of outstanding principal of the 2027 Term Loans will be made in five equal quarterly payments of principal commencing March 31, 2026. The Company adopted the prospective method to account for future cash payments. Under the prospective method, the effective interest rate is not constant, and any change in the expected cash flows is recognized prospectively as an adjustment to the effective yield. The obligations under the Loan Agreement are secured pursuant to customary security documentation, including a guaranty and security agreement among the Credit Parties and the Collateral Agent which provides for a lien on substantially all of the Company’s tangible and intangible assets and property, including intellectual property. Pursuant to the Loan Agreement, and subject to certain restrictions, proceeds of the 2027 Term Loans were used to fund the Company’s general corporate and working capital requirements except for the following: in January 2022, proceeds of the Tranche A Loan were used to repay in full all amounts outstanding under the Company’s $75.0 million aggregate principal credit agreement with affiliates of Healthcare Royalty Partners (the “2025 Term Loan”), as well as all associated costs and expenses pursuant to which a payoff amount of $81.9 million was outstanding; in March 2022, proceeds of the Tranche B Loan were drawn in connection with the full repayment of all amounts outstanding under the Company’s $100.0 million aggregate principal amount 8.2% Convertible Senior Notes (the “2022 Convertible Notes”), as well as all associated costs and expenses pursuant to which a payoff amount of $111.1 million was outstanding. The Loan Agreement contains certain customary representations and warranties. In addition, the Loan Agreement includes affirmative covenants, such as the requirement to maintain minimum trailing twelve-month net sales in an amount that begins at $200.0 million for the quarter ending March 31, 2022, increases to $210.0 million for the quarter ended March 31, 2024, increases to $230.0 million for the quarter ending June 30, 2024, increases to $270.0 million for the quarter ending September 30, 2024, and increases to $300.0 million for the quarter ended December 31, 2024 and thereafter. Further, the Loan Agreement includes certain other affirmative covenants and negative covenants, including, covenants and restrictions that among other things, restrict the Company’s ability to incur liens, incur additional indebtedness, make investments, engage in certain mergers and acquisitions or asset sales, and declare dividends or redeem or repurchase capital stock. The Loan Agreement also contains customary events of default, including among other things, the Company’s failure to make any principal or interest payments when due, the occurrence of certain bankruptcy or insolvency events or its breach of the covenants under the Loan Agreement. Upon the occurrence of an event of default, the Lenders may, among other things, accelerate the Company’s obligations under the Loan Agreement. A change of control of the Company triggers a mandatory prepayment of the 2027 Term Loans within ten business days. As of March 31, 2023, the Company was in full compliance with these covenants, other than the requirement in Section 6.15(a) that the trailing twelve-month net sales for the fiscal quarter ended March 31, 2023 not be less than $200.0 million for which the Company obtained a valid waiver, and there were no events of default under the 2027 Term Loans. In connection with the closing of Tranche A, the Company incurred $7.8 million in debt discounts and issuance costs of which $6.8 million related to all the tranches of the 2027 Term Loans and was thus allocated pro rata between the tranches. The unamortized debt discount and issuance costs allocated to funded tranches are presented as deductions to the 2027 Term Loan balance and are amortized into interest expense using the effective interest method. The $2.3 million allocated to Tranche B was fully amortized over the commitment period prior to funding and recognized as interest expense in the first quarter of 2022. The associated debt discounts and issuance costs of unfunded tranches were deferred as assets and amortized into interest expense using the straight-line method over the commitment period of the respective tranches. At the closing dates of Tranche B on March 31, 2022 and Tranche D on September 14, 2022, the Company incurred an additional $1.0 million and $0.5 million, respectively, in debt issuance costs. As of March 31, 2023, the total remaining unamortized debt discount and debt offering costs related to Tranches A, B and D of $4.3 million will be amortized using the effective interest rate over the remaining term of 3.8 years. The following table presents the components of interest expense related to the 2027 Term Loans: Three Months Ended March 31, (in thousands) 2023 2022 Stated coupon interest $ 8,145 $ 2,210 Amortization of debt discount and debt issuance costs 332 2,841 Total interest expense $ 8,477 $ 5,051 Future payments on the 2027 Term Loans as of March 31, 2023 are as follows: Year ending December 31, (in thousands) Remainder of 2023 - interest only $ 24,887 2024 - interest only 33,123 2025 - interest only 33,032 2026 - principal and interest 223,060 2027 - principal and interest 50,090 Total minimum payments 364,192 Less amount representing interest (114,192) 2027 Term Loans, gross 250,000 Less unamortized debt discount and debt issuance costs, net (4,282) Net carrying amount of 2027 Term Loans $ 245,718 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, 2023, the Company was in full compliance with these covenants and there were no events of default under the 2026 Convertible Notes. The Company evaluated the features embedded in the 2026 Convertible Notes under the relevant accounting rules and concluded that the embedded features do not meet the requirements for bifurcation, and therefore do not need to be separately accounted for as an equity component. The proceeds received from the issuance of the convertible debt were recorded as a liability 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, 2023, the holders of the 2026 Convertible Notes would have received common shares with an aggregate value of $81.7 million based on the Company’s closing stock price of $6.84 as of March 31, 2023. The following table presents the components of interest expense related to the 2026 Convertible Notes: Three Months Ended March 31, (in thousands) 2023 2022 Stated coupon interest $ 863 $ 863 Amortization of debt discount and debt issuance costs 326 319 Total interest expense $ 1,189 $ 1,182 The remaining unamortized debt discount and debt offering costs related to the Company’s 2026 Convertible Notes of $4.1 million as of March 31, 2023, will be amortized using the effective interest rate over the remaining term of the 2026 Convertible Notes. The annual effective interest rate is 2.1% for the 2026 Convertible Notes. Future payments on the 2026 Convertible Notes as of March 31, 2023 are as follows: Year ending December 31, (in thousands) Remainder of 2023 - interest only $ 3,450 2024 - interest only 3,450 2025 - interest only 3,450 2026 231,725 Total minimum payments 242,075 Less amount representing interest (12,075) 2026 Convertible Notes, principal amount 230,000 Less unamortized debt discount and debt issuance costs (4,100) Net carrying amount of 2026 Convertible Notes $ 225,900 8.2% Convertible Notes due 2022 On February 29, 2016, the Company issued and sold $100.0 million aggregate principal amount of its 8.2% Convertible Senior Notes due 2022. The 2022 Convertible Notes constituted general, senior unsubordinated obligations of the Company s a result had no continuing obligations associated with them thereafter 2025 Term Loan On January 7, 2019, the Company entered into a credit agreement with affiliates of Healthcare Royalty Partners. The 2025 Term Loan consisted of a six-year term loan facility for an aggregate principal amount of $75.0 million (the “Borrowings”). Pursuant to the terms of the 2025 Term Loan, the Company was required to begin paying principal on the Borrowings in equal quarterly installments beginning on the |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2023 | |
Commitments and Contingencies. | |
Commitments and Contingencies | 8. Commitments and Contingencies Purchase Commitments The Company entered into agreements with certain vendors to secure raw materials and certain CMOs to manufacture its supply of products. As of March 31, 2023, the Company’s non-cancelable purchase commitments under the terms of its agreements are as follows: Year ending December 31, (in thousands) 2023* $ 34,666 2024 32,643 2025 4,435 2026 5,469 2027 5,470 Total obligations $ 82,683 * Reflects a reduction compared to December 31, 2022 resulting from a contract change to lower the number of UDENYCA batches to be produced at a specific CMO. 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, 2023 and December 31, 2022, the Company had an accrual of $6.4 million and $4.7 million, respectively, related to such matters that was included in accrued rebates, fees and reserves in the 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’s accrual as of March 31, 2023 represented its estimated liability to resolve the matter. Loss contingencies are inherently unpredictable, the assessment is highly subjective and requires judgments about future events and unfavorable developments or resolutions can occur. The Company regularly reviews litigation matters to determine whether its accrual is adequate. The amount of ultimate loss may differ materially from the amount accrued to date. Other than the matter in connection with the demand letter described in this Note 8, there are no pending legal proceedings, other than ordinary routine litigation incidental to the business, to which the Company or any of its subsidiaries is a party, or that any of the Company or its subsidiaries' property is subject. |
Derivatives
Derivatives | 3 Months Ended |
Mar. 31, 2023 | |
Derivatives | |
Derivatives | 9. Derivatives The Company is exposed to foreign currency exchange rate risk related to its international purchases. In the first quarter of 2023, the Company started utilizing euro currency contracts to manage euro currency risk in purchasing inventory and future settlement of euro denominated assets and liabilities. The volume of the Company’s foreign currency contract activity is limited by the amount of transaction exposure in each foreign currency and the Company’s election whether to hedge the transactions. There are no derivative instruments entered into for speculative or trading purposes. The Company did not elect hedge accounting for any of its currency contracts. All outstanding contracts are with the same counterparty. Changes in the net fair value of contracts are recorded in other income (expense), net in the condensed consolidated statements of operations. The Company's derivatives are euro currency contracts which are economic hedges and have settlement dates through September 30, 2023. The following table summarizes the derivative fair value: March 31, 2023 (in thousands) Balance Sheet Classification Notional Fair Value Derivative assets Other prepaids and current assets $ 4,850 $ 44 Derivative liabilities Accrued and other current liabilities $ 7,300 $ 167 The pre-tax gain (loss) of foreign currency contracts not designated as hedging instruments were recorded on the condensed consolidated statements of operations as follows: Three Months Ended (in thousands) Statement of Operations Classification March 31, 2023 Currency contracts Other income (expense), net $ (123) |
At The Market Offering
At The Market Offering | 3 Months Ended |
Mar. 31, 2023 | |
At-The-Market Offering | |
At The Market Offering | On November 8, 2022, the Company filed a registration statement on Form S-3, which was declared effective on November 17, 2022 (the “Registration Statement”) . Under the Registration Statement, the Company may offer and sell up to $150.0 million in the aggregate of its common stock, preferred stock, debt securities, warrants and units from time to time in one or more offerings. Also on November 8, 2022, the Company entered into a sales agreement (“Sales Agreement”) with Cowen and Company, LLC (“Cowen”), pursuant to which the Company may issue and sell from time to time up to $150.0 million of its common stock through or to Cowen as the Company’s sales agent or principal in an at-the-market offering (“ATM Offering”) . During the three months ended March 31, 2023, the Company sold 1,131,450 shares of common stock at a weighted-average price per share of $6.54 for gross proceeds of $7.4 million pursuant to the ATM Offering and received net proceeds of $7.2 million, net of $0.2 million of commissions and fees. As of March 31, 2023, the Company had approximately $135.9 million of its common stock remaining available for sales under the ATM Offering. |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2023 | |
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) 2023 2022 Cost of goods sold (1) $ 125 $ 155 Research and development 5,461 4,958 Selling, general and administrative 6,696 7,766 Stock-based compensation expense $ 12,282 $ 12,879 Stock-based compensation expense capitalized into inventory $ 131 $ 313 (1) Stock-based compensation capitalized into inventory is recognized as cost of goods sold when the related product is sold. The stock-based compensation for the three months ended March 31, 2023 includes restructuring charges described in Note 13 of $1.1 million in research and development expense and a net forfeiture credit of $0.1 million in selling, general and administrative expense. |
Net Loss Per Share
Net Loss Per Share | 3 Months Ended |
Mar. 31, 2023 | |
Net Loss Per Share | |
Net Loss Per Share | 12. Net Loss Per Share Basic net loss per share is calculated by dividing the net loss by the weighted-average number of shares of common stock outstanding for the period, without consideration for potential dilutive common shares. Diluted net loss per share is computed by dividing net loss by the weighted-average number of common shares outstanding for the period, without consideration for any potential dilutive common share equivalents as their effect would be antidilutive. The following outstanding dilutive potential shares were excluded from the calculation of diluted net loss per share due to their anti-dilutive effect: Three Months Ended March 31, 2023 2022 Stock options, including shares subject to ESPP 23,996,096 21,947,102 Restricted stock units 2,586,168 2,479,655 Shares issuable upon conversion of 2022 Convertible Notes — 4,324,742 Shares issuable upon conversion of 2026 Convertible Notes 11,942,152 11,942,152 Total 38,524,416 40,693,651 |
Restructuring Charges
Restructuring Charges | 3 Months Ended |
Mar. 31, 2023 | |
Restructuring Charges. | |
Restructuring Charges | 13. Restructuring Charges On March 3, 2023, the Company committed to a plan to reduce its workforce to focus resources on strategic priorities including the commercialization of its diversified product portfolio and development of innovative immuno-oncology product candidates. The reduction in force impacted approximately 50 full-time and part-time employees, effective March 10, 2023 for most of these employees. Non-recurring restructuring charges associated with the reduction in force consisted of $3.9 million in cash expenses related to personnel expenses such as salaries, severance payments and other benefits; and $1.5 million in non-cash stock-based compensation related to acceleration of vesting and extension of the stock option exercise windows for two impacted executives; partially offset by $0.5 million in non-cash stock-based compensation forfeiture credits. The reduction in force is expected to be substantially completed during the first half of 2023. For the three months ended March 31, 2023, the condensed consolidated statement of operations includes $3.6 million in research and development expense and $1.3 million in selling, general and administrative expense related to the reduction in force. The condensed consolidated balance sheet includes $1.0 million in accrued compensation as of March 31, 2023. Any additional charges are expected to be insignificant. |
Organization and Significant _2
Organization and Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2023 | |
Organization and 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, 2022 (the “2022 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 judgements, estimates and assumptions that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosures. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances. These estimates form the basis for making judgments about the carrying values of assets and liabilities when these values are not readily apparent from other sources. Estimates are assessed each period and updated to reflect current information. Accounting estimates and judgements 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: 2023 2022 Cash and cash equivalents $ 63,547 $ 417,195 Restricted cash 440 440 Total cash, cash equivalents and restricted cash $ 63,987 $ 417,635 March 31, At end of period: 2023 2022 Cash and cash equivalents $ 16,145 $ 325,680 Restricted cash 440 440 Total cash, cash equivalents and restricted cash $ 16,585 $ 326,120 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. |
Investments in Marketable Securities | 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. |
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, 2023 and December 31, 2022. |
Derivative Instruments | Derivative Instruments In January 2023, the Company commenced using derivative contracts (foreign exchange option contracts) for the purpose of economically hedging exposure to changes in currency fluctuations between the U.S. Dollar and the Euro. The Company recognizes all derivatives at fair value in the condensed consolidated balance sheets, and corresponding gains and losses are recognized in other income (expense), net in the condensed consolidated statements of operations. The estimated fair value of derivative financial instruments represents the amount required to enter into similar contracts with similar remaining maturities based on quoted market prices. During the periods presented, the Company did not apply hedge accounting to these instruments (see Note 9). |
Recent Accounting Pronouncements | Recent Accounting Pronouncements The Company has reviewed recent accounting pronouncements and concluded they are either not applicable to the business or that no material effect is expected on the condensed consolidated financial statements as a result of future adoption. |
Organization and Significant _3
Organization and Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Organization and 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: 2023 2022 Cash and cash equivalents $ 63,547 $ 417,195 Restricted cash 440 440 Total cash, cash equivalents and restricted cash $ 63,987 $ 417,635 March 31, At end of period: 2023 2022 Cash and cash equivalents $ 16,145 $ 325,680 Restricted cash 440 440 Total cash, cash equivalents and restricted cash $ 16,585 $ 326,120 |
Revenue (Tables)
Revenue (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Revenue | |
Net revenue initiated sales in the United States of total net revenue | Three Months Ended March 31, (in thousands) 2023 2022 Products UDENYCA $ 26,179 $ 60,069 CIMERLI 6,174 — Total net product revenue 32,353 60,069 Other 83 46 Total net revenue $ 32,436 $ 60,115 |
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, 2023 2022 McKesson Corporation 35 % 39 % AmeriSource-Bergen Corporation 43 % 43 % Cardinal Health, Inc. 21 % 17 % |
Activities and Ending Reserve Balances for Each Significant Category of Discounts and Allowances | The 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, 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 (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 Three Months Ended March 31, 2022 Chargebacks Other Fees, and Discounts Co-pay for Prompt Assistance (in thousands) Payment Rebates and Returns Total Balances at December 31, 2021 $ 29,665 $ 54,004 $ 26,054 $ 109,723 Provision related to sales made in: Current period 105,737 20,269 20,288 146,294 Prior period (1,081) (1,721) (344) (3,146) Payments and customer credits issued (107,625) (24,216) (22,440) (154,281) Balances at March 31, 2022 $ 26,696 $ 48,336 $ 23,558 $ 98,590 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Fair Value Measurements | |
Financial Assets and Liabilities Measured on a Recurring Basis | Financial assets and liabilities measured at fair value on a recurring basis are summarized as follows: Fair Value Measurements March 31, 2023 (in thousands) Level 1 Level 2 Level 3 Total Financial Assets: Money market funds $ 11,712 $ — $ — $ 11,712 Marketable debt securities: U.S. government agency securities 15,120 — — 15,120 U.S. treasury securities 50,036 — — 50,036 Commercial paper and corporate notes — 46,788 — 46,788 Currency contracts — 44 — 44 Total $ 76,868 $ 46,832 $ — $ 123,700 Financial Liabilities: Currency contracts $ — $ 167 $ — $ 167 Fair Value Measurements December 31, 2022 (in thousands) Level 1 Level 2 Level 3 Total Financial Assets: Money market funds $ 55,060 $ — $ — $ 55,060 Marketable debt securities: U.S. government agency securities 19,964 — — 19,964 U.S. treasury securities 68,418 — — 68,418 Commercial paper and corporate notes — 48,203 — 48,203 Total $ 143,442 $ 48,203 $ — $ 191,645 |
Cash and cash equivalents, marketable securities and restricted cash | March 31, 2023 (in thousands) Cost Unrealized Gain Unrealized (Loss) Fair Value Money market funds $ 11,712 $ — $ — $ 11,712 U.S. government agency securities 15,109 13 (2) 15,120 U.S. treasury securities 50,042 3 (9) 50,036 Commercial paper and corporate notes 46,800 — (12) 46,788 Total $ 123,663 $ 16 $ (23) $ 123,656 December 31, 2022 (in thousands) Cost Unrealized Gain Unrealized (Loss) Fair Value Money market funds $ 55,060 $ — $ — $ 55,060 U.S. government agency securities 19,929 35 — 19,964 U.S. treasury securities 68,431 8 (21) 68,418 Commercial paper and corporate notes 48,203 — — 48,203 Total $ 191,623 $ 43 $ (21) $ 191,645 |
Inventory (Tables)
Inventory (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Inventory | |
Schedule of Inventory | Inventory consisted of the following: March 31, December 31, (in thousands) 2023 2022 Raw materials $ 13,008 $ 10,262 Work in process 82,206 86,712 Finished goods 19,273 18,077 Total $ 114,487 $ 115,051 |
Schedule of Balance Sheet Classification | March 31, December 31, (in thousands) 2023 2022 Inventory $ 49,406 $ 38,791 Inventory, non-current 65,081 76,260 Total $ 114,487 $ 115,051 |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Organization and Operations | |
Schedule of Property and Equipment, Net | Property and equipment, net consisted of the following: March 31, December 31, (in thousands) 2023 2022 Machinery and equipment $ 13,031 $ 12,944 Computer equipment and software 3,127 3,183 Furniture and fixtures 1,258 1,258 Leasehold improvements 6,234 6,198 Finance lease right of use assets 4,070 4,632 Construction in progress 524 696 Total property and equipment 28,244 28,911 Accumulated depreciation and amortization (20,520) (20,157) Property and equipment, net $ 7,724 $ 8,754 |
Schedule of Accrued Liabilities | Accrued and other current liabilities consisted of the following: March 31, December 31, (in thousands) 2023 2022 Accrued commercial and research and development manufacturing $ 9,677 $ 21,774 Accrued co-development costs payable to Junshi Biosciences 3,480 8,356 Lease liabilities, current 4,436 4,318 Accrued other 14,464 15,649 Total Accrued and other current liabilities $ 32,057 $ 50,097 |
Debt Obligations (Tables)
Debt Obligations (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Debt Instrument | |
Summary of the Company's Debt Obligations | A summary of the Company’s debt obligations, including level within the fair value hierarchy (see Note 3), is as follows: At March 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 $ (4,282) $ 245,718 $ 245,718 Level 2* 2026 Convertible Notes $ 230,000 $ (4,100) $ 225,900 $ 159,358 Level 2** At December 31, 2022 (in thousands) Principal Amount Unamortized Debt Discount and Debt Issuance Costs Net Carrying Value Estimated Fair Value Level Financial Liabilities: 2027 Term Loans $ 250,000 $ (4,517) $ 245,483 $ 245,483 Level 2* 2026 Convertible Notes $ 230,000 $ (4,425) $ 225,575 $ 157,205 Level 2** * The principal amounts outstanding are subject to variable interest rates, which are based on three-month SOFR starting April 1, 2023 plus fixed percentages. Through March 31, 2023, the variable component was based on the three-month LIBOR. Therefore, the Company believes the carrying amount of these obligations approximates fair value. ** 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 | |
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) 2023 2022 Stated coupon interest $ 8,145 $ 2,210 Amortization of debt discount and debt issuance costs 332 2,841 Total interest expense $ 8,477 $ 5,051 |
Schedule of Future Payments on Debt | Future payments on the 2027 Term Loans as of March 31, 2023 are as follows: Year ending December 31, (in thousands) Remainder of 2023 - interest only $ 24,887 2024 - interest only 33,123 2025 - interest only 33,032 2026 - principal and interest 223,060 2027 - principal and interest 50,090 Total minimum payments 364,192 Less amount representing interest (114,192) 2027 Term Loans, gross 250,000 Less unamortized debt discount and debt issuance costs, net (4,282) Net carrying amount of 2027 Term Loans $ 245,718 |
1.5% Convertible Senior Subordinated Notes due 2026 | |
Debt Instrument | |
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) 2023 2022 Stated coupon interest $ 863 $ 863 Amortization of debt discount and debt issuance costs 326 319 Total interest expense $ 1,189 $ 1,182 |
Schedule of Future Payments on Debt | Year ending December 31, (in thousands) Remainder of 2023 - interest only $ 3,450 2024 - interest only 3,450 2025 - interest only 3,450 2026 231,725 Total minimum payments 242,075 Less amount representing interest (12,075) 2026 Convertible Notes, principal amount 230,000 Less unamortized debt discount and debt issuance costs (4,100) Net carrying amount of 2026 Convertible Notes $ 225,900 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Commitments and Contingencies. | |
Schedule of Non-cancelable Contractual Obligations | Year ending December 31, (in thousands) 2023* $ 34,666 2024 32,643 2025 4,435 2026 5,469 2027 5,470 Total obligations $ 82,683 |
Derivatives (Tables)
Derivatives (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Derivatives | |
Schedule of derivative fair value | March 31, 2023 (in thousands) Balance Sheet Classification Notional Fair Value Derivative assets Other prepaids and current assets $ 4,850 $ 44 Derivative liabilities Accrued and other current liabilities $ 7,300 $ 167 |
Schedule of pre-tax gain (loss) of foreign currency contracts not designated as hedging instruments | Three Months Ended (in thousands) Statement of Operations Classification March 31, 2023 Currency contracts Other income (expense), net $ (123) |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
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) 2023 2022 Cost of goods sold (1) $ 125 $ 155 Research and development 5,461 4,958 Selling, general and administrative 6,696 7,766 Stock-based compensation expense $ 12,282 $ 12,879 Stock-based compensation expense capitalized into inventory $ 131 $ 313 (1) Stock-based compensation capitalized into inventory is recognized as cost of goods sold when the related product is sold. |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Net Loss Per Share | |
Outstanding Dilutive Potential Shares Excluded from Calculation of Diluted Net loss Per Share | The following outstanding dilutive potential shares were excluded from the calculation of diluted net loss per share due to their anti-dilutive effect: Three Months Ended March 31, 2023 2022 Stock options, including shares subject to ESPP 23,996,096 21,947,102 Restricted stock units 2,586,168 2,479,655 Shares issuable upon conversion of 2022 Convertible Notes — 4,324,742 Shares issuable upon conversion of 2026 Convertible Notes 11,942,152 11,942,152 Total 38,524,416 40,693,651 |
Organization and Significant _4
Organization and Significant Accounting Policies - Organization (Details) | Mar. 31, 2023 product |
Organization and Significant Accounting Policies | |
Product pipeline, number of product candidates | 3 |
Organization and Significant _5
Organization and Significant Accounting Policies - Cash, Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 | Mar. 31, 2022 | Dec. 31, 2021 |
Organization and Significant Accounting Policies | ||||
Cash and cash equivalents | $ 16,145 | $ 63,547 | $ 325,680 | $ 417,195 |
Restricted cash | 440 | 440 | 440 | 440 |
Total cash, cash equivalents and restricted cash | $ 16,585 | $ 63,987 | $ 326,120 | $ 417,635 |
Revenue - net revenue (Details)
Revenue - net revenue (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Disaggregation of Revenue [Line Items] | ||
Net revenue | $ 32,436 | $ 60,115 |
Total net product revenue | ||
Disaggregation of Revenue [Line Items] | ||
Net revenue | 32,353 | 60,069 |
UDENYCA | ||
Disaggregation of Revenue [Line Items] | ||
Net revenue | 26,179 | 60,069 |
CIMERLI | ||
Disaggregation of Revenue [Line Items] | ||
Net revenue | 6,174 | |
Other | ||
Disaggregation of Revenue [Line Items] | ||
Net revenue | $ 83 | $ 46 |
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, 2023 | Mar. 31, 2022 | |
McKesson | ||
Concentration Risk | ||
Percentage of total gross revenue | 35% | 39% |
AmeriSource-Bergen Corp | ||
Concentration Risk | ||
Percentage of total gross revenue | 43% | 43% |
Cardinal | ||
Concentration Risk | ||
Percentage of total gross revenue | 21% | 17% |
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, 2023 | Mar. 31, 2022 | |
Accounts Notes And Loans Receivable | ||
Activities and reserve balance, beginning balance | $ 100,503 | $ 109,723 |
Provision related to sales made in: | ||
Current period | 121,509 | 146,294 |
Prior period | 390 | (3,146) |
Payments and customer credits issued | (131,968) | (154,281) |
Activities and reserve balance, ending balance | 90,434 | 98,590 |
Chargebacks and Discounts for Prompt Payment | ||
Accounts Notes And Loans Receivable | ||
Activities and reserve balance, beginning balance | 42,677 | 29,665 |
Provision related to sales made in: | ||
Current period | 93,906 | 105,737 |
Prior period | (738) | (1,081) |
Payments and customer credits issued | (101,108) | (107,625) |
Activities and reserve balance, ending balance | 34,737 | 26,696 |
Rebates | ||
Accounts Notes And Loans Receivable | ||
Activities and reserve balance, beginning balance | 38,713 | 54,004 |
Provision related to sales made in: | ||
Current period | 13,000 | 20,269 |
Prior period | (701) | (1,721) |
Payments and customer credits issued | (14,243) | (24,216) |
Activities and reserve balance, ending balance | 36,769 | 48,336 |
Other Fees, Co-pay Assistance and Returns | ||
Accounts Notes And Loans Receivable | ||
Activities and reserve balance, beginning balance | 19,113 | 26,054 |
Provision related to sales made in: | ||
Current period | 14,603 | 20,288 |
Prior period | 1,829 | (344) |
Payments and customer credits issued | (16,617) | (22,440) |
Activities and reserve balance, ending balance | $ 18,928 | $ 23,558 |
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, 2023 | Dec. 31, 2022 |
Financial assets measured at fair value on a recurring basis | ||
Total financial assets | $ 123,700 | $ 191,645 |
Currency contracts | ||
Financial assets measured at fair value on a recurring basis | ||
Total financial liabilities | 167 | |
Level 1 | ||
Financial assets measured at fair value on a recurring basis | ||
Total financial assets | 76,868 | 143,442 |
Level 1 | Currency contracts | ||
Financial assets measured at fair value on a recurring basis | ||
Total financial liabilities | 0 | |
Level 2 | ||
Financial assets measured at fair value on a recurring basis | ||
Total financial assets | 46,832 | 48,203 |
Level 2 | Currency contracts | ||
Financial assets measured at fair value on a recurring basis | ||
Total financial liabilities | 167 | |
Level 3 | ||
Financial assets measured at fair value on a recurring basis | ||
Total financial assets | 0 | |
Level 3 | Currency contracts | ||
Financial assets measured at fair value on a recurring basis | ||
Total financial liabilities | 0 | |
U.S. government agency securities | ||
Financial assets measured at fair value on a recurring basis | ||
Total financial assets | 15,120 | 19,964 |
U.S. government agency securities | Level 1 | ||
Financial assets measured at fair value on a recurring basis | ||
Total financial assets | 15,120 | 19,964 |
U.S. government agency securities | Level 2 | ||
Financial assets measured at fair value on a recurring basis | ||
Total financial assets | 0 | |
U.S. government agency securities | Level 3 | ||
Financial assets measured at fair value on a recurring basis | ||
Total financial assets | 0 | |
US Treasury Securities | ||
Financial assets measured at fair value on a recurring basis | ||
Total financial assets | 50,036 | 68,418 |
US Treasury Securities | Level 1 | ||
Financial assets measured at fair value on a recurring basis | ||
Total financial assets | 50,036 | 68,418 |
US Treasury Securities | Level 2 | ||
Financial assets measured at fair value on a recurring basis | ||
Total financial assets | 0 | |
US Treasury Securities | Level 3 | ||
Financial assets measured at fair value on a recurring basis | ||
Total financial assets | 0 | |
Commercial paper and corporate notes | ||
Financial assets measured at fair value on a recurring basis | ||
Total financial assets | 46,788 | 48,203 |
Commercial paper and corporate notes | Level 1 | ||
Financial assets measured at fair value on a recurring basis | ||
Total financial assets | 0 | |
Commercial paper and corporate notes | Level 2 | ||
Financial assets measured at fair value on a recurring basis | ||
Total financial assets | 46,788 | 48,203 |
Commercial paper and corporate notes | Level 3 | ||
Financial assets measured at fair value on a recurring basis | ||
Total financial assets | 0 | |
Money market funds | ||
Financial assets measured at fair value on a recurring basis | ||
Total financial assets | 11,712 | 55,060 |
Money market funds | Level 1 | ||
Financial assets measured at fair value on a recurring basis | ||
Total financial assets | 11,712 | $ 55,060 |
Money market funds | Level 2 | ||
Financial assets measured at fair value on a recurring basis | ||
Total financial assets | 0 | |
Money market funds | Level 3 | ||
Financial assets measured at fair value on a recurring basis | ||
Total financial assets | 0 | |
Currency contracts, Assets | ||
Financial assets measured at fair value on a recurring basis | ||
Total financial assets | 44 | |
Currency contracts, Assets | Level 1 | ||
Financial assets measured at fair value on a recurring basis | ||
Total financial assets | ||
Currency contracts, Assets | Level 2 | ||
Financial assets measured at fair value on a recurring basis | ||
Total financial assets | 44 | |
Currency contracts, Assets | Level 3 | ||
Financial assets measured at fair value on a recurring basis | ||
Total financial assets | $ 0 |
Fair Value Measurements - Cost,
Fair Value Measurements - Cost, Unrealized Gains or Losses, and Fair Value by Investment Type (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cost | $ 123,663 | $ 191,623 |
Unrealized Gain | 16 | 43 |
Unrealized (Loss) | (23) | (21) |
Fair Value | 123,656 | 191,645 |
Money Market Funds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cost | 11,712 | 55,060 |
Fair Value | 11,712 | 55,060 |
U.S. government agency securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cost | 15,109 | 19,929 |
Unrealized Gain | 13 | 35 |
Unrealized (Loss) | (2) | |
Fair Value | 15,120 | 19,964 |
US Treasury Securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cost | 50,042 | 68,431 |
Unrealized Gain | 3 | 8 |
Unrealized (Loss) | (9) | (21) |
Fair Value | 50,036 | 68,418 |
Commercial paper and corporate notes | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cost | 46,800 | 48,203 |
Unrealized (Loss) | (12) | |
Fair Value | $ 46,788 | $ 48,203 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) $ in Thousands | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2023 USD ($) position | Mar. 31, 2022 USD ($) | Dec. 31, 2022 USD ($) | |
Fair Value Measurements | |||
Fair Value, Assets, Level 1 to Level 2 Transfers, Amount | $ 0 | $ 0 | |
Fair Value, Assets, Level 2 to Level 1 Transfers, Amount | 0 | 0 | |
Fair Value, Liabilities, Level 1 to Level 2 Transfers, Amount | 0 | 0 | |
Fair Value, Liabilities, Level 2 to Level 1 Transfers, Amount | 0 | 0 | |
Fair Value, Measurement with Unobservable Inputs Reconciliation, Recurring Basis, Asset, Transfers, Net | 0 | 0 | |
Fair Value, Measurement with Unobservable Inputs Reconciliation, Recurring Basis, Liability, Transfers, Net | $ 0 | $ 0 | |
Unrealized Gain (Loss) on Securities | $ 0 | ||
Positions that were in unrealized loss positions | position | 11 | ||
Long lived assets, material impairments | $ 0 | ||
Remaining contractual maturities of available-for-sale securities | 1 year | ||
Average maturity of investments upon acquisition | 8 months | ||
Investments in marketable securities | $ 0 |
Inventory (Details)
Inventory (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Inventory | ||
Raw materials | $ 13,008 | $ 10,262 |
Work in process | 82,206 | 86,712 |
Finished goods | 19,273 | 18,077 |
Total | $ 114,487 | $ 115,051 |
Inventory - Balance Sheet Class
Inventory - Balance Sheet Classifications (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Inventory | ||
Inventory | $ 49,406 | $ 38,791 |
Inventory, non-current | 65,081 | 76,260 |
Total | $ 114,487 | $ 115,051 |
Inventory - Additional Informat
Inventory - Additional Information (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Inventory [Line Items] | ||
Inventory | $ 49,406 | $ 38,791 |
Prepayment made for manufacturing services | 16,019 | 17,880 |
Prepayments made to a CMO for manufacturing services for UDENYCA | 11,600 | 13,000 |
Prepayments made to a CMO For Other Research And Development Pipeline Program | 4,400 | 4,900 |
Yusimry Product [Member] | ||
Inventory [Line Items] | ||
Inventory | $ 25,100 | $ 23,700 |
Balance Sheet Components - Sche
Balance Sheet Components - Schedule of Property and Equipment, Net (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Property and Equipment, Net | ||
Total property and equipment | $ 28,244 | $ 28,911 |
Accumulated depreciation and amortization | (20,520) | (20,157) |
Property and equipment, net | 7,724 | 8,754 |
Machinery and Equipment | ||
Property and Equipment, Net | ||
Total property and equipment | 13,031 | 12,944 |
Computer Equipment and Software | ||
Property and Equipment, Net | ||
Total property and equipment | 3,127 | 3,183 |
Furniture and Fixtures | ||
Property and Equipment, Net | ||
Total property and equipment | 1,258 | 1,258 |
Leasehold Improvements | ||
Property and Equipment, Net | ||
Total property and equipment | 6,234 | 6,198 |
Finance lease right of use assets | ||
Property and Equipment, Net | ||
Total property and equipment | 4,070 | 4,632 |
Construction in Progress | ||
Property and Equipment, Net | ||
Total property and equipment | $ 524 | $ 696 |
Balance Sheet Components - Addi
Balance Sheet Components - Additional Information (Details) - USD ($) $ in Millions | Mar. 31, 2023 | Dec. 31, 2022 | Mar. 31, 2022 |
Balance Sheet Components | |||
Depreciation and amortization expense related to property and equipment | $ 0.9 | $ 0.8 | |
Software implementation costs | $ 3.2 | $ 3.5 |
Balance Sheet Components - Accr
Balance Sheet Components - Accrued and Other Current Liabilities (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Balance Sheet Components | ||
Accrued commercial and research and development manufacturing | $ 9,677 | $ 21,774 |
Accrued co-development costs payable to Junshi Biosciences | 3,480 | 8,356 |
Lease liabilities, current | 4,436 | 4,318 |
Accrued other | 14,464 | 15,649 |
Total Accrued and other current liabilities | $ 32,057 | $ 50,097 |
Collaborations and Other Arra_2
Collaborations and Other Arrangements (Details) $ / shares in Units, $ in Thousands, € in Millions | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||||||
Feb. 01, 2021 USD ($) item | Nov. 04, 2019 EUR (€) | Mar. 31, 2022 USD ($) | Mar. 31, 2023 USD ($) $ / shares | Dec. 31, 2022 EUR (€) | Mar. 31, 2022 USD ($) | Jun. 30, 2023 EUR (€) | Dec. 31, 2019 USD ($) | Dec. 31, 2019 EUR (€) | Dec. 31, 2022 USD ($) | Apr. 14, 2020 $ / shares | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions | |||||||||||
License Agreement Fee | $ 35,000 | ||||||||||
Royalties due | $ 2,500 | $ 2,900 | |||||||||
Research and development | $ 34,154 | $ 82,917 | |||||||||
Share Price | $ / shares | $ 6.84 | $ 14.82 | |||||||||
Finite-Lived Intangible Asset, Useful Life | 10 years | ||||||||||
Bioeq IP AG | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | |||||||||||
Initial term of agreement | 10 years | ||||||||||
Bioeq IP AG | Licensed Products | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | |||||||||||
Maximum aggregate milestone payments | € | € 12.5 | ||||||||||
Additional milestone payments related to FDA approval | € | € 2.5 | ||||||||||
Bioeq IP AG | Research and Development Expense [Member] | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | |||||||||||
Upfront and milestone payment | $ 11,100 | € 10 | |||||||||
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 | 170,000 | |||||||||
Junshi Biosciences | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | |||||||||||
Undisclosed preclinical | item | 2 | ||||||||||
License Agreement Fee | $ 35,000 | ||||||||||
Collaboration agreement, royalty on net sales for each exercised option, percentage | 18% | ||||||||||
Collaboration agreement, Maximum aggregate one-time payment for achievement of milestones, for each option program | $ 85,000 | ||||||||||
Maximum paid amount for co-development activities (per licensed compound) | 25,000 | ||||||||||
Research and development | $ 2,100 | $ 50,100 | |||||||||
Junshi Biosciences | Accrued and other current liabilities | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | |||||||||||
Co-development, regulatory and technology transfer costs | 3,500 | ||||||||||
Junshi Biosciences | Accounts payable | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | |||||||||||
Co-development, regulatory and technology transfer costs | $ 2,100 | ||||||||||
Junshi Biosciences | Toripalimab | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | |||||||||||
Collaboration Agreement, upfront amount paid | $ 150,000 | ||||||||||
Collaboration agreement, royalty on net sales, percentage | 20% | ||||||||||
Collaboration agreement, Maximum aggregate one-time payments for the achievement of various regulatory and sales milestones | $ 380,000 | ||||||||||
Scenario, Plan | Term Sheet Agreement | Klinge Biopharma | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | |||||||||||
Collaboration Agreement, upfront amount paid | € | € 30 |
Debt Obligations - Summary of D
Debt Obligations - Summary of Debt Obligations (Details) - Level 2 - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
2027 Term Loans | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Principal amount | $ 250,000 | $ 250,000 |
Unamortized debt discount and debt issuance costs | (4,282) | (4,517) |
Net carrying value | 245,718 | 245,483 |
Estimated fair value | 245,718 | 245,483 |
1.5% Convertible Senior Subordinated Notes due 2026 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Principal amount | 230,000 | 230,000 |
Unamortized debt discount and debt issuance costs | (4,100) | (4,425) |
Net carrying value | 225,900 | 225,575 |
Estimated fair value | $ 159,358 | $ 157,205 |
Debt Obligations - 2027 Term Lo
Debt Obligations - 2027 Term Loan - Narrative (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | |||||||
Jan. 07, 2019 USD ($) | Mar. 31, 2022 USD ($) | Jan. 31, 2022 USD ($) item | Mar. 31, 2023 USD ($) | Mar. 31, 2022 USD ($) | Sep. 14, 2022 USD ($) | Jan. 05, 2022 USD ($) tranche | Apr. 30, 2020 USD ($) | Feb. 29, 2016 USD ($) | |
Debt Instrument [Line Items] | |||||||||
Outstanding amount paid off | $ 81,750 | ||||||||
Outstanding amount payoff | 109,000 | ||||||||
2027 Term Loans | |||||||||
Debt Instrument [Line Items] | |||||||||
Debt Instrument, Interest Rate During Period | 13.03% | ||||||||
2027 Term Loans | BioPharma Credit Investments V GP LLC | |||||||||
Debt Instrument [Line Items] | |||||||||
Principal amount | $ 300,000 | ||||||||
Number of tranches | tranche | 4 | ||||||||
Net carrying value | $ 245,718 | ||||||||
Quarterly payments | item | 5 | ||||||||
Loan agreement covenants, minimum trailing twelve month net sales for current quarter | $ 200,000 | 200,000 | |||||||
Loan agreement covenants, minimum trailing twelve month net sales for the quarter ended March 30, 2024 | 210,000 | ||||||||
Loan agreement covenants, minimum trailing twelve-month net sales for the quarter ended June 30, 2024 | 230,000 | ||||||||
Loan agreement covenants, minimum trailing twelve-month net sales for the quarter ended September 30, 2024 | 270,000 | ||||||||
Loan agreement covenants, minimum trailing twelve-month net sales for the quarter ended December 31, 2024 and thereafter | $ 300,000 | ||||||||
Mandatory prepayment term | 10 days | ||||||||
Debt discounts and issuance costs | $ 6,800 | ||||||||
Remaining unamortized debt discount and debt offering costs | $ 4,282 | ||||||||
2027 Term Loans | Additional facility amount | BioPharma Credit Investments V GP LLC | |||||||||
Debt Instrument [Line Items] | |||||||||
Principal amount | $ 100,000 | ||||||||
2027 Term Loans | Through March 31, 2023 | BioPharma Credit Investments V GP LLC | |||||||||
Debt Instrument [Line Items] | |||||||||
Stated interest rate | 8.25% | ||||||||
2027 Term Loans | Through March 31, 2023 | BioPharma Credit Investments V GP LLC | Three-month LIBOR | |||||||||
Debt Instrument [Line Items] | |||||||||
Floor On Variable Rate | 1% | ||||||||
2027 Term Loans | Starting April 1, 2023 | Secured Overnight Financing Rate (SOFR) Overnight Index Swap Rate [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Amount added to the variable component | 0.26161% | ||||||||
Floor On Variable Rate | 1% | ||||||||
2027 Term Loans | Starting April 1, 2023 | BioPharma Credit Investments V GP LLC | |||||||||
Debt Instrument [Line Items] | |||||||||
Stated interest rate | 8.25% | ||||||||
Tranche A Loan, funded January 5, 2022 | BioPharma Credit Investments V GP LLC | |||||||||
Debt Instrument [Line Items] | |||||||||
Principal amount | $ 100,000 | ||||||||
Debt discounts and issuance costs | $ 7,800 | ||||||||
Tranche B Loan, funded on March 31, 2022 | BioPharma Credit Investments V GP LLC | |||||||||
Debt Instrument [Line Items] | |||||||||
Principal amount | $ 100,000 | 100,000 | |||||||
Debt discounts and issuance costs | 2,300 | ||||||||
Convertible notes, Issuance Cost | $ 1,000 | $ 1,000 | |||||||
Tranche C Loan, not funded between April 1, 2022 and March 17, 2023 | BioPharma Credit Investments V GP LLC | |||||||||
Debt Instrument [Line Items] | |||||||||
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 | ||||||||
Convertible notes, Issuance Cost | $ 500 | ||||||||
1.5% Convertible Senior Subordinated Notes due 2026 | Convertible Notes | |||||||||
Debt Instrument [Line Items] | |||||||||
Principal amount | $ 230,000 | ||||||||
Net carrying value | $ 225,900 | ||||||||
Stated interest rate | 1.50% | ||||||||
Remaining unamortized debt discount and debt offering costs | $ 4,100 | ||||||||
Effective interest rate | 2.10% | ||||||||
1.5% Convertible Senior Subordinated Notes due 2026 | BioPharma Credit Investments V GP LLC | Scenario, Plan | Minimum | |||||||||
Debt Instrument [Line Items] | |||||||||
Principal amount | 50,000 | ||||||||
8.2% Convertible Notes due 2022 | Convertible Notes | |||||||||
Debt Instrument [Line Items] | |||||||||
Principal amount | 100,000 | $ 100,000 | |||||||
Stated interest rate | 8.20% | 8.20% | 8.20% | ||||||
Outstanding amount payoff | $ 111,100 | 111,100 | |||||||
2025 Term Loan | Lender | |||||||||
Debt Instrument [Line Items] | |||||||||
Principal amount | $ 75,000 | 75,000 | |||||||
Outstanding amount paid off | $ 81,900 | ||||||||
Total term of the loan | 6 years | ||||||||
Tranches A, B and D | BioPharma Credit Investments V GP LLC | |||||||||
Debt Instrument [Line Items] | |||||||||
Remaining unamortized debt discount and debt offering costs | $ 4,300 | ||||||||
Remaining term | 3 years 9 months 18 days |
Debt Obligations - 2027 Term _2
Debt Obligations - 2027 Term Loans Interest Expense Components (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Debt Instrument [Line Items] | ||
Amortization of debt discount and debt issuance costs | $ 656 | $ 3,696 |
2027 Term Loans | BioPharma Credit Investments V GP LLC | ||
Debt Instrument [Line Items] | ||
Stated coupon interest | 8,145 | 2,210 |
Amortization of debt discount and debt issuance costs | 332 | 2,841 |
Total Interest expense | $ 8,477 | $ 5,051 |
Debt Obligations - 2027 Term _3
Debt Obligations - 2027 Term Loan Future Payments (Details) - 2027 Term Loans - BioPharma Credit Investments V GP LLC $ in Thousands | Mar. 31, 2023 USD ($) |
Debt Instrument [Line Items] | |
Remainder of 2023 - interest only | $ 24,887 |
2024 - interest only | 33,123 |
2025 - interest only | 33,032 |
2026 - principal and interest | 223,060 |
2027 - principal and interest | 50,090 |
Total minimum payments | 364,192 |
Less amount representing interest | (114,192) |
Term Loan, gross | 250,000 |
Less unamortized debt discount and debt issuance costs, net | (4,282) |
Net carrying amount of Term Loans | $ 245,718 |
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, 2023 USD ($) $ / shares | Apr. 14, 2020 $ / shares | |
Debt Instrument | |||
Closing stock, price per share | $ / shares | $ 6.84 | $ 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, 2023, the Company was in full compliance with these covenants and there were no events of default under the 2026 Convertible Notes. | ||
Debt issuance costs | $ 900,000 | ||
Remaining unamortized debt discount and debt offering costs | $ 4,100,000 | ||
Effective interest rate | 2.10% | ||
Convertible Notes | 1.5% Convertible Senior Subordinated Notes due 2026 | Scenario, Plan | |||
Debt Instrument | |||
Convertible notes, converted amount | $ 81,700,000 |
Debt Obligations - Capped Call
Debt Obligations - Capped Call Transactions - Narrative (Details) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | ||
Apr. 30, 2020 | Mar. 31, 2023 | Apr. 14, 2020 | |
Option Indexed to Issuer's Equity [Line Items] | |||
Closing stock, price per share | $ 6.84 | $ 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) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Debt Instrument | ||
Amortization of debt discount and debt issuance costs | $ 656 | $ 3,696 |
1.5% Convertible Senior Subordinated Notes due 2026 | Convertible Notes | ||
Debt Instrument | ||
Stated coupon interest | 863 | 863 |
Amortization of debt discount and debt issuance costs | 326 | 319 |
Total Interest expense | $ 1,189 | $ 1,182 |
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, 2023 USD ($) |
Debt Instrument | |
Remainder of 2023 - interest only | $ 3,450 |
2024 - interest only | 3,450 |
2025 - interest only | 3,450 |
2026 | 231,725 |
Total minimum payments | 242,075 |
Less amount representing interest | (12,075) |
2026 Convertible Notes, principal amount | 230,000 |
Less unamortized debt discount and debt issuance costs | (4,100) |
Net carrying amount of Term Loans | $ 225,900 |
Debt Obligations - Convertibl_2
Debt Obligations - Convertible Notes due 2022 Narrative (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | ||||
Feb. 29, 2016 | Mar. 31, 2022 | Jan. 31, 2022 | Mar. 31, 2023 | Mar. 31, 2022 | Apr. 14, 2020 | |
Debt Instrument | ||||||
Outstanding amount payoff | $ 109,000 | |||||
Closing stock, price per share | $ 6.84 | $ 14.82 | ||||
Amortization of debt discount and debt issuance costs | $ 656 | 3,696 | ||||
8.2% Convertible Notes due 2022 | ||||||
Debt Instrument | ||||||
Interest expense | 2,600 | |||||
Interest rate description | The 2022 Convertible Notes constituted general, senior unsubordinated obligations of the Company bore interest at a fixed coupon rate of 8.2% per annum payable quarterly in arrears and matured on March 31, 2022. | |||||
Fixed debt interest expense | $ 2,100 | 2,100 | ||||
Amortization of debt discount and debt issuance costs | $ 500 | |||||
Convertible Notes | 8.2% Convertible Notes due 2022 | ||||||
Debt Instrument | ||||||
Principal amount | $ 100,000 | $ 100,000 | ||||
Stated interest rate | 8.20% | 8.20% | 8.20% | |||
Debt instrument maturity date | Mar. 31, 2022 | |||||
Outstanding amount payoff | $ 111,100 | $ 111,100 | ||||
Convertible Notes Payable | $ 0 | $ 0 | ||||
Convertible notes, premium percentage | 9% |
Debt Obligations - 2025 Term Lo
Debt Obligations - 2025 Term Loan - Narrative (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | |
Jan. 07, 2019 | Jan. 31, 2022 | Mar. 31, 2022 | |
Debt Instrument | |||
Outstanding amount paid off | $ 81,750 | ||
Loss on debt extinguishment | (6,222) | ||
Lender | 2025 Term Loan | |||
Debt Instrument | |||
Total term of the loan | 6 years | ||
Principal amount | $ 75,000 | $ 75,000 | |
Outstanding amount paid off | $ 81,900 | ||
Prepayment premium percentage | 5% | ||
Percentage required to pay an additional exit fee on principal amount | 4% | ||
Loss on debt extinguishment | $ (6,200) | ||
Interest expense | $ 200 |
Commitments and Contingencies -
Commitments and Contingencies - Schedule of Non-Cancelable Contractual Obligations (Details) $ in Thousands | Mar. 31, 2023 USD ($) |
Commitments and Contingencies. | |
2023 | $ 34,666 |
2024 | 32,643 |
2025 | 4,435 |
2026 | 5,469 |
2027 | 5,470 |
Total obligations | $ 82,683 |
Commitments and Contingencies_2
Commitments and Contingencies - Additional Information (Details) - USD ($) $ in Millions | 1 Months Ended | ||
Apr. 30, 2022 | Mar. 31, 2023 | Dec. 31, 2022 | |
Loss Contingencies | |||
Claims related to certain sales of UDENYCA from October 2020 through December 2021 | $ 14 | ||
Accrued rebates, fees and reserves | |||
Loss Contingencies | |||
Accruals | $ 6.4 | $ 4.7 |
Derivatives - Derivative fair v
Derivatives - Derivative fair value (Details) $ in Thousands | Mar. 31, 2023 USD ($) derivative |
Derivatives, Fair Value [Line Items] | |
Number of Derivative Instrument Held For Trading or Speculative Purpose | derivative | 0 |
Currency contracts | Economic hedge, not designated as hedging instrument | |
Derivatives, Fair Value [Line Items] | |
Derivative assets, Notional | $ 4,850 |
Derivative liabilities, Notional | 7,300 |
Derivative assets, Fair Value | $ 44 |
Derivative Asset, Current, Statement of Financial Position [Extensible Enumeration] | Prepaid Expense And Other Assets Current |
Derivative liabilities, Fair Value | $ 167 |
Derivative Liability, Current, Statement of Financial Position [Extensible Enumeration] | Accrued Liabilities Current |
Derivatives - Pre-tax gain (los
Derivatives - Pre-tax gain (loss) of foreign currency contracts not designated as hedging instruments (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2023 USD ($) | |
Derivatives | |
Currency contracts recorded in Other income (expense), net | $ (123) |
At-The-Market Offering (Details
At-The-Market Offering (Details) - At The Market Offering. - USD ($) $ / shares in Units, $ in Millions | 3 Months Ended | |
Nov. 08, 2022 | Mar. 31, 2023 | |
At-The-Market Offering | ||
Aggregate offering price | $ 150 | |
Common stock, shares issued and sold | 1,131,450 | |
Share price | $ 6.54 | |
Gross proceeds from issuance of common stock | $ 7.4 | |
Common stock, net proceeds | 7.2 | |
Commissions and fees | 0.2 | |
Common stock remaining available for sales under the ATM Offering | $ 135.9 |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock-Based Compensation (Details) - Employee And Nonemployee Stock Option And Restricted Stock Units [Member] - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs | ||
Stock-based compensation expense | $ 12,282 | $ 12,879 |
Stock-based compensation expense capitalized into inventory | 131 | 313 |
Cost of Goods Sold | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs | ||
Stock-based compensation expense | 125 | 155 |
Research and Development Expense [Member] | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs | ||
Stock-based compensation expense | 5,461 | 4,958 |
Selling, General and Administrative Expenses | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs | ||
Stock-based compensation expense | $ 6,696 | $ 7,766 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Details) - Employee Severance [Member] - USD ($) $ in Millions | 3 Months Ended | |
Mar. 03, 2023 | Mar. 31, 2023 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Stock-based compensation includes restructuring charges | $ 1.5 | |
Forfeiture credit | $ 0.5 | |
Research and Development Expense [Member] | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Stock-based compensation includes restructuring charges | $ 1.1 | |
Selling, General and Administrative Expenses | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Forfeiture credit | $ 0.1 |
Net Loss Per Share - Outstandin
Net Loss Per Share - Outstanding Dilutive Potential Shares Excluded from Calculation of Diluted Net loss Per Share (Details) - shares | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Antidilutive securities excluded from computation of EPS | ||
Antidilutive securities excluded from the calculation of diluted net (loss) income per share | 38,524,416 | 40,693,651 |
Stock options, including shares subject to ESPP | ||
Antidilutive securities excluded from computation of EPS | ||
Antidilutive securities excluded from the calculation of diluted net (loss) income per share | 23,996,096 | 21,947,102 |
Restricted Stock Units | ||
Antidilutive securities excluded from computation of EPS | ||
Antidilutive securities excluded from the calculation of diluted net (loss) income per share | 2,586,168 | 2,479,655 |
8.2% Convertible Notes due 2022 | Shares Issuable Upon Conversion of Convertible Notes | ||
Antidilutive securities excluded from computation of EPS | ||
Antidilutive securities excluded from the calculation of diluted net (loss) income per share | 4,324,742 | |
1.5% Convertible Senior Subordinated Notes due 2026 | Shares Issuable Upon Conversion of Convertible Notes | ||
Antidilutive securities excluded from computation of EPS | ||
Antidilutive securities excluded from the calculation of diluted net (loss) income per share | 11,942,152 | 11,942,152 |
Restructuring Charges (Details)
Restructuring Charges (Details) - Employee Severance $ in Millions | 3 Months Ended | ||
Mar. 10, 2023 employee | Mar. 03, 2023 USD ($) item | Mar. 31, 2023 USD ($) | |
Restructuring Cost And Reserve [Line Items] | |||
Employees impacted | employee | 50 | ||
Restructuring Charges | $ 3.9 | ||
Stock-based compensation includes restructuring charges | 1.5 | ||
Forfeiture credit | $ 0.5 | ||
Restructuring And Related Activities | item | 2 | ||
Restructuring Reserve | $ 1 | ||
Research and Development Expense | |||
Restructuring Cost And Reserve [Line Items] | |||
Restructuring Charges | 3.6 | ||
Stock-based compensation includes restructuring charges | 1.1 | ||
Selling, General and Administrative Expenses | |||
Restructuring Cost And Reserve [Line Items] | |||
Restructuring Charges | 1.3 | ||
Forfeiture credit | $ 0.1 |