Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2022 | Jul. 31, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Jun. 30, 2022 | |
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, $0.0001 par value per share | |
Trading Symbol | CHRS | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 77,724,589 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q2 | |
Entity Central Index Key | 0001512762 | |
Amendment Flag | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 275,484 | $ 417,195 |
Trade receivables, net | 115,711 | 123,022 |
Inventory | 31,744 | 37,642 |
Prepaid manufacturing | 7,176 | 13,666 |
Other prepaid and other assets | 16,669 | 10,798 |
Total current assets | 446,784 | 602,323 |
Property and equipment, net | 9,553 | 7,813 |
Inventory, non-current | 75,954 | 55,610 |
Goodwill and intangible assets | 3,563 | 3,563 |
Other assets, non-current | 10,149 | 10,025 |
Total assets | 546,003 | 679,334 |
Current liabilities: | ||
Accounts payable | 17,486 | 16,159 |
Accrued rebates, fees and reserves | 64,547 | 79,027 |
Accrued compensation | 16,928 | 22,014 |
Accrued and other current liabilities | 41,793 | 48,127 |
Total current liabilities | 140,754 | 165,327 |
Term loans | 196,037 | 75,513 |
2026 Convertible Notes | 224,928 | 332,767 |
Lease liabilities, non-current | 6,811 | 7,251 |
Other liabilities, non-current | 102 | 750 |
Total liabilities | 568,632 | 581,608 |
Commitments and contingencies (Note 8) | ||
Stockholders' equity (deficit): | ||
Common stock ($0.0001 par value; shares authorized: 300,000,000; shares issued and outstanding: 77,702,749 and 76,930,096 at June 30, 2022 and December 31, 2021, respectively) | 7 | 7 |
Additional paid-in capital | 1,173,722 | 1,147,843 |
Accumulated other comprehensive loss | (270) | (270) |
Accumulated deficit | (1,196,088) | (1,049,854) |
Total stockholders' equity (deficit) | (22,629) | 97,726 |
Total liabilities and stockholders' equity (deficit) | $ 546,003 | $ 679,334 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parentheticals) - $ / shares | Jun. 30, 2022 | Dec. 31, 2021 |
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 | 77,702,749 | 76,930,096 |
Common stock, shares outstanding | 77,702,749 | 76,930,096 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Revenue: | ||||
Net revenue | $ 60,151 | $ 87,643 | $ 120,266 | $ 170,677 |
Costs and expenses: | ||||
Cost of goods sold | 11,277 | 16,696 | 20,647 | 24,207 |
Research and development | 41,611 | 54,766 | 124,528 | 258,258 |
Selling, general and administrative | 51,276 | 40,345 | 100,029 | 79,736 |
Total costs and expenses | 104,164 | 111,807 | 245,204 | 362,201 |
Loss from operations | (44,013) | (24,164) | (124,938) | (191,524) |
Interest expense | (6,580) | (5,747) | (15,549) | (11,395) |
Loss on debt extinguishment | (6,222) | |||
Other income, net | 443 | 11 | 475 | 72 |
Loss before income taxes | (50,150) | (29,900) | (146,234) | (202,847) |
Net loss | $ (50,150) | $ (29,900) | $ (146,234) | $ (202,847) |
Net loss per share: | ||||
Basic net loss per share | $ (0.65) | $ (0.40) | $ (1.89) | $ (2.73) |
Diluted net loss per share | $ (0.65) | $ (0.40) | $ (1.89) | $ (2.73) |
Weighted-average number of shares used in computing net loss per share: | ||||
Weighted-average number of shares used in computing basic net loss per share | 77,554,717 | 75,559,697 | 77,405,040 | 74,203,858 |
Weighted-average number of shares used in computing diluted net loss per share | 77,554,717 | 75,559,697 | 77,405,040 | 74,203,858 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Condensed Consolidated Statements of Comprehensive Loss | ||||
Net loss | $ (50,150) | $ (29,900) | $ (146,234) | $ (202,847) |
Other comprehensive loss: | ||||
Unrealized gain on available-for-sale securities, net of tax | 40 | 0 | 3 | |
Foreign currency translation adjustments, net of tax | 2 | 0 | ||
Comprehensive loss | $ (50,148) | $ (29,860) | $ (146,234) | $ (202,844) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive Loss | Accumulated Deficit | Total |
Beginning Balances at Dec. 31, 2020 | $ 7 | $ 1,043,991 | $ (270) | $ (762,754) | $ 280,974 |
Beginning Balances (in shares) at Dec. 31, 2020 | 72,513,348 | ||||
Net loss | (172,947) | (172,947) | |||
Issuance of common stock upon exercise of stock options | 4,429 | 4,429 | |||
Issuance of common stock upon exercise of stock options (in shares) | 451,883 | ||||
Issuance of common stock upon vesting of RSUs (in shares) | 252,846 | ||||
Stock-based compensation expense | 16,982 | 16,982 | |||
Taxes paid related to net share settlement of RSUs | (1,730) | (1,730) | |||
Taxes paid related to net share settlement of RSUs (in shares) | (95,169) | ||||
Other comprehensive gain, net of tax | (37) | (37) | |||
Ending Balances at Mar. 31, 2021 | $ 7 | 1,063,672 | (307) | (935,701) | 127,671 |
Ending Balances (in shares) at Mar. 31, 2021 | 73,122,908 | ||||
Beginning Balances at Dec. 31, 2020 | $ 7 | 1,043,991 | (270) | (762,754) | 280,974 |
Beginning Balances (in shares) at Dec. 31, 2020 | 72,513,348 | ||||
Net loss | (202,847) | ||||
Ending Balances at Jun. 30, 2021 | $ 7 | 1,122,081 | (267) | (965,601) | 156,220 |
Ending Balances (in shares) at Jun. 30, 2021 | 76,464,700 | ||||
Beginning Balances at Mar. 31, 2021 | $ 7 | 1,063,672 | (307) | (935,701) | 127,671 |
Beginning Balances (in shares) at Mar. 31, 2021 | 73,122,908 | ||||
Net loss | (29,900) | (29,900) | |||
Issuance of common stock upon exercise of stock options | 4,009 | 4,009 | |||
Issuance of common stock upon exercise of stock options (in shares) | 686,145 | ||||
Issuance of common stock upon vesting of RSUs (in shares) | 9,334 | ||||
Stock-based compensation expense | 11,512 | 11,512 | |||
Issuance of common stock to Shanghai Junshi Biosciences Ltd. ("Junshi Biosciences"), net of issuance costs | 40,903 | 40,903 | |||
Issuance of common stock to Shanghai Junshi Biosciences Ltd. ("Junshi Biosciences"), net of issuance costs (in shares) | 2,491,988 | ||||
Issuance of common stock under the ESPP | 1,985 | 1,985 | |||
Issuance of common stock under the ESPP (in shares) | 154,325 | ||||
Other comprehensive gain, net of tax | 40 | 40 | |||
Ending Balances at Jun. 30, 2021 | $ 7 | 1,122,081 | (267) | (965,601) | 156,220 |
Ending Balances (in shares) at Jun. 30, 2021 | 76,464,700 | ||||
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 | 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 gain, 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, 2021 | $ 7 | 1,147,843 | (270) | (1,049,854) | $ 97,726 |
Beginning Balances (in shares) at Dec. 31, 2021 | 76,930,096 | 76,930,096 | |||
Net loss | $ (146,234) | ||||
Cumulative translation adjustment | 0 | ||||
Ending Balances at Jun. 30, 2022 | $ 7 | 1,173,722 | (270) | (1,196,088) | $ (22,629) |
Ending Balances (in shares) at Jun. 30, 2022 | 77,702,749 | 77,702,749 | |||
Beginning Balances at Mar. 31, 2022 | $ 7 | 1,158,766 | (272) | (1,145,938) | $ 12,563 |
Beginning Balances (in shares) at Mar. 31, 2022 | 77,338,171 | ||||
Net loss | (50,150) | (50,150) | |||
Issuance of common stock upon exercise of stock options | 8 | 8 | |||
Issuance of common stock upon exercise of stock options (in shares) | 4,499 | ||||
Issuance of common stock upon vesting of RSUs (in shares) | 173,867 | ||||
Stock-based compensation expense | 13,935 | 13,935 | |||
Issuance of common stock under the ESPP | 1,655 | 1,655 | |||
Issuance of common stock under the ESPP (in shares) | 244,983 | ||||
Taxes paid related to net share settlement of RSUs | (642) | (642) | |||
Taxes paid related to net share settlement of RSUs (in shares) | (58,771) | ||||
Other comprehensive gain, net of tax | 2 | 2 | |||
Cumulative translation adjustment | 2 | ||||
Ending Balances at Jun. 30, 2022 | $ 7 | $ 1,173,722 | $ (270) | $ (1,196,088) | $ (22,629) |
Ending Balances (in shares) at Jun. 30, 2022 | 77,702,749 | 77,702,749 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows - USD ($) | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Operating activities | ||
Net loss | $ (146,234,000) | $ (202,847,000) |
Adjustments to reconcile net loss to net cash (used in) provided by operating activities: | ||
Depreciation and amortization | 1,654,000 | 1,726,000 |
Stock-based compensation expense | 26,729,000 | 28,479,000 |
Write-off of prepaid manufacturing services related to the termination of CHS-2020 | 3,210,000 | |
Non-cash interest expense from amortization of debt discount & issuance costs | 4,677,000 | 2,064,000 |
Upfront and option payments to Junshi Biosciences | 35,000,000 | 136,000,000 |
Loss on debt extinguishment | 6,222,000 | |
Other non-cash adjustments, net | 1,208,000 | 1,896,000 |
Changes in operating assets and liabilities: | ||
Trade receivables, net | 7,327,000 | 15,243,000 |
Inventory | (14,203,000) | (3,860,000) |
Prepaid manufacturing | 6,490,000 | 2,335,000 |
Other prepaid, current and non-current assets | (6,223,000) | (3,556,000) |
Accounts payable | 1,423,000 | (773,000) |
Accrued rebates, fees and reserves | (14,480,000) | 2,229,000 |
Accrued compensation | (5,086,000) | (7,428,000) |
Accrued and other current and non-current liabilities | (8,586,000) | 26,461,000 |
Net cash (used in) provided by operating activities | (104,082,000) | 1,179,000 |
Investing activities | ||
Purchases of property and equipment | (1,495,000) | (560,000) |
Purchases of investments in marketable securities | (140,330,000) | |
Proceeds from maturities of investments in marketable securities | 15,000,000 | |
Upfront and option payments to Junshi Biosciences | (35,000,000) | (136,000,000) |
Net cash used in investing activities | (36,495,000) | (261,890,000) |
Financing activities | ||
Proceeds from 2027 Term Loans, net of debt discount & issuance costs | 191,190,000 | |
Proceeds from issuance of common stock to Junshi Biosciences, net of issuance costs | 40,903,000 | |
Proceeds from issuance of common stock upon exercise of stock options | 552,000 | 8,446,000 |
Proceeds from purchase under the employee stock purchase plan | 1,655,000 | 1,985,000 |
Taxes paid related to net share settlement of RSUs | (3,300,000) | (1,730,000) |
Repayment of 2022 Convertible Notes and premiums | (109,000,000) | |
Repayment of 2025 Term Loan, premiums and exit fees | (81,750,000) | |
Other financing activities | (481,000) | (313,000) |
Net cash (used in) provided by financing activities | (1,134,000) | 49,291,000 |
Net decrease in cash, cash equivalents and restricted cash | (141,711,000) | (211,420,000) |
Cash, cash equivalents and restricted cash at beginning of period | 417,635,000 | 541,598,000 |
Cash, cash equivalents and restricted cash at end of period | $ 275,924,000 | $ 330,178,000 |
Organization and Summary of Sig
Organization and Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2022 | |
Organization and Summary of Significant Accounting Policies | |
Organization and Summary of 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 develop and commercialize innovative cancer treatments 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) (ranibizumab-eqrn) The Company’s product pipeline comprises the following four product candidates: toripalimab, an anti-PD-1 antibody being developed in collaboration with Junshi Biosciences; CHS-006, an antibody targeting TIGIT being developed in collaboration with Junshi Biosciences; and two wholly-owned preclinical immuno-oncology programs, CHS-1000, an antibody targeting ILT4, and CHS-3318, an antibody targeting CCR8. In May 2022, the Company discontinued development of its bevacizumab (Avastin) biosimilar product candidate from Innovent Biologics (Suzhou) Co., Ltd. (“Innovent”). 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, 2021 (the “2021 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 for the six months ended June 30, 2022 and 2021: (in thousands) At January 1, At beginning of period: 2022 2021 Cash and cash equivalents $ 417,195 $ 541,158 Restricted cash 440 440 Total cash, cash equivalents and restricted cash $ 417,635 $ 541,598 At June 30, At end of period: 2022 2021 Cash and cash equivalents $ 275,484 $ 329,738 Restricted cash 440 440 Total cash, cash equivalents and restricted cash $ 275,924 $ 330,178 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 Investments in marketable securities primarily consist of corporate debt obligations and commercial paper. Management determines the appropriate classification of investments in marketable securities at the time of purchase based upon management’s intent with regards to such investment and reevaluates such designation as of each balance sheet date. The Company’s investment policy requires that it only invests in highly rated securities and limit its exposure to any single issuer. All investments in debt marketable securities are held as “available-for-sale” and are carried at the estimated fair value as determined based upon quoted market prices or pricing models for similar securities. The Company classifies investments in marketable securities as short-term when they have remaining contractual maturities of one year or less from the balance sheet date. Unrealized gains and losses on available-for-sale securities are reported as a component of accumulated comprehensive income (loss), with the exception of unrealized losses believed to be related to credit losses, if any, which are recognized in earnings in the period the impairment occurs. Impairment assessments are made at the individual security level each reporting period. When the fair value of an investment is less than its cost at the balance sheet date, a determination is made as to whether the impairment is related to a credit loss and, if it is, the portion of the impairment relating to credit loss is recorded as an allowance through net income. Realized gains and losses on available-for-sale securities are included in other income, net, based on the specific identification method. 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 June 30, 2022 and December 31, 2021. 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 | 6 Months Ended |
Jun. 30, 2022 | |
Revenue | |
Revenue | 2. Revenue The Company recorded net revenue of $60.2 million and $120.3 million during the three and six months ended June 30, 2022, respectively, and $87.6 million and $170.7 million during the three and six months ended June 30, 2021, respectively. Gross revenues by significant customer as a percentage of total gross revenues are as follows: Three Months Ended Six Months Ended June 30, 2022 June 30, 2021 June 30, 2022 June 30, 2021 McKesson Corporation 36 % 39 % 37 % 39 % AmeriSource-Bergen Corporation 46 % 38 % 45 % 38 % Cardinal Health, Inc. 17 % 22 % 17 % 21 % 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: Six Months Ended June 30, 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 220,178 38,075 39,353 297,606 Prior period (2,147) (3,165) (556) (5,868) Payments and customer credits issued (216,130) (44,816) (44,402) (305,348) Balances at June 30, 2022 $ 31,566 $ 44,098 $ 20,449 $ 96,113 Six Months Ended June 30, 2021 Chargebacks Other Fees, and Discounts Co-pay for Prompt Assistance (in thousands) Payment Rebates and Returns Total Balances at December 31, 2020 $ 40,580 $ 54,058 $ 28,760 $ 123,398 Provision related to sales made in: Current period 237,745 61,190 50,039 348,974 Prior period (2,850) (1,890) (2,818) (7,558) Payments and customer credits issued (247,641) (52,213) (50,726) (350,580) Balances at June 30, 2021 $ 27,834 $ 61,145 $ 25,255 $ 114,234 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 | 6 Months Ended |
Jun. 30, 2022 | |
Fair Value Measurements | |
Fair Value Measurements | 3. Fair Value Measurements The fair values of financial instruments are classified into one of the following categories: ● Level 1 — Quoted prices in active markets for identical assets or liabilities. ● Level 2 — Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. ● Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. A financial instrument’s categorization within the valuation hierarchy is based upon the lowest level of input that is significant to the fair value measurement. Where quoted prices are available in an active market, securities are classified as Level 1. Level 1 assets consist of highly liquid money market funds that are included in cash and cash equivalents, and restricted cash. There were no transfers between Level 1, Level 2 and Level 3 during the periods presented. Financial assets and liabilities subject to fair value measurements on a recurring basis and the level of inputs used in such measurements were as follows: Fair Value Measurements June 30, 2022 (in thousands) Level 1 Level 2 Level 3 Total Financial Assets: Cash and cash equivalents (money market funds) $ 275,484 $ — $ — $ 275,484 Restricted cash (money market funds) 440 — — 440 Total financial assets $ 275,924 $ — $ — $ 275,924 Fair Value Measurements December 31, 2021 (in thousands) Level 1 Level 2 Level 3 Total Financial Assets: Cash and cash equivalents (money market funds) $ 417,165 $ — $ — $ 417,165 Restricted cash (money market funds) 440 — — 440 Total financial assets $ 417,605 $ — $ — $ 417,605 |
Inventory
Inventory | 6 Months Ended |
Jun. 30, 2022 | |
Inventory | |
Inventory | 4. Inventory Inventory consisted of the following: June 30, December 31, (in thousands) 2022 2021 Raw materials $ 7,685 $ 4,870 Work in process 69,593 65,117 Finished goods 30,420 23,265 Total $ 107,698 $ 93,252 The Company began capitalizing YUSIMRY inventory in the second quarter of 2022 and had $1.9 million of such inventory recognized on the balance sheet at June 30, 2022. 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 June 30, 2022 and December 31, 2021, the non-current portion of inventory consisted of raw materials, work in process and a portion of finished goods. The following tables presents the inventory balance sheet classifications: June 30, December 31, (in thousands) 2022 2021 Inventory $ 31,744 $ 37,642 Inventory, non-current 75,954 55,610 Total $ 107,698 $ 93,252 Prepaid manufacturing of $7.2 million as of June 30, 2022 includes prepayments of $3.5 million to a contract manufacturing organization (“CMO”) for manufacturing services for UDENYCA, which the Company expects to be converted into inventory within the next twelve months; and prepayments of $3.7 million to various CMOs for research and development pipeline programs. Prepaid manufacturing of $13.7 million as of December 31, 2021 included prepayments of $8.3 million to a CMO for manufacturing services for UDENYCA; and prepayments of $5.4 million to various CMOs for research and development pipeline programs. In February 2021, the Company announced the discontinuation of the development of CHS-2020, a biosimilar of Eylea® as part of a realignment of research and development resources toward other development programs. As a result, during the quarter ended March 31, 2021, the Company recognized $11.5 million within research and development expenses on its condensed consolidated statement of operations, which included an impairment charge of $3.2 million for the write-off of prepaid manufacturing services no longer deemed to have future benefits. No expense relating to the discontinuation of CHS-2020 was recognized in the second quarter of 2021. |
Balance Sheet Components
Balance Sheet Components | 6 Months Ended |
Jun. 30, 2022 | |
Balance Sheet Components | |
Balance Sheet Components | 5. Balance Sheet Components Property and Equipment, Net Property and equipment, net consists of the following: June 30, December 31, (in thousands) 2022 2021 Machinery and equipment $ 12,564 $ 11,876 Computer equipment and software 3,052 3,033 Furniture and fixtures 1,161 1,129 Leasehold improvements 6,145 5,942 Finance lease right of use assets 4,223 2,294 Construction in progress 788 388 Total property and equipment 27,933 24,662 Accumulated depreciation and amortization (18,380) (16,849) Property and equipment, net $ 9,553 $ 7,813 Depreciation and amortization expense was $0.9 million and $1.7 million for the three and six months ended June 30, 2022, respectively, and $0.9 million and $1.7 million for the three and six months ended June 30, 2021, respectively. Accrued and Other Current Liabilities Accrued and other current liabilities are summarized as follows: June 30, December 31, (in thousands) 2022 2021 Accrued manufacturing and clinical $ 14,781 $ 30,541 Accrued co-development costs for toripalimab 12,025 1,926 Lease liabilities, current 3,988 3,492 Accrued other 10,999 12,168 Total Accrued and other current liabilities $ 41,793 $ 48,127 |
Collaborations and Other Arrang
Collaborations and Other Arrangements | 6 Months Ended |
Jun. 30, 2022 | |
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. The Company will lead further development of CHS-006 and will be responsible for the associated development costs as set forth in the Collaboration Agreement. If the Company exercises its remaining option for the IL-2 cytokine, it will be obligated to pay an additional option exercise fee of $35.0 million. Additionally, for each exercised option, the Company will be obligated to pay Junshi Biosciences an 18% royalty on net sales, up to $85.0 million for the achievement of certain regulatory approvals, and up to $170.0 million for the attainment of certain sales thresholds. Under the Collaboration Agreement, the Company retains the right to collaborate in the development of toripalimab and the other licensed compounds, including CHS-006, and will pay for a portion of these co-development activities up to a maximum of $25.0 million per licensed compound per year. Additionally, the Company is responsible for certain associated regulatory and technology transfer costs for toripalimab and other licensed compounds and will reimburse Junshi Biosciences for such costs. The licensing transaction and the exercise of the option were accounted for as asset acquisitions under the relevant accounting rules. The Company recognized research and development expense of $9.9 million in the second quarter of 2022 and $60.0 million in the six months ended June 30, 2022, inclusive of the $35.0 million option fee incurred in the first quarter. Research and development expense was $6.5 million and $158.2 million for the three and six months ended June 30, 2021, respectively; the first quarter of 2021 included $145.0 million for the upfront payment for the exclusive rights to toripalimab and the second quarter included a credit of $9.0 million for the discount for lack of marketability (“DLOM”), discussed below. Accrued and other current liabilities on the condensed consolidated balance sheet as of June 30, 2022 included $12.0 million related to the co-development, regulatory and technology transfer costs related to these programs. The Company entered into a right of first negotiation agreement with Junshi Biosciences and paid a fee of $5.0 million which was fully expensed as research and development expense in the fourth quarter of 2020. The right of first negotiation fee was fully credited against the total upfront license fee obligation under the Collaboration Agreement. As of June 30, 2022, the Company did not have any outstanding milestone or royalty payment obligations to Junshi Biosciences. The additional milestone payments, option fee for the IL-2 cytokine and royalties are contingent upon future events and, therefore, will be recorded if and when it becomes probable that a milestone will be achieved, or when an option fee or royalties are incurred. In connection with the Collaboration Agreement, the Company entered into a stock purchase agreement (the “Stock Purchase Agreement”) with Junshi Biosciences agreeing, subject to customary conditions, to acquire certain equity interests in the Company. Pursuant to the Stock Purchase Agreement, on April 16, 2021, the Company issued 2,491,988 unregistered shares of its common stock to Junshi Biosciences, at a price per share of $20.06, for an aggregate value of $50.0 million cash. Under the terms of the Stock Purchase Agreement, Junshi Biosciences is not permitted to sell, transfer, make any short sale of, or grant any option for the sale of the common stock for the two-year period following its effective date. The Collaboration Agreement and the Stock Purchase Agreement were negotiated concurrently and were therefore evaluated as a single agreement. The Company used the “Finnerty” and “Asian put” valuation models and determined the fair value for the DLOM was $9.0 million at the date the shares were issued. The fair value of the DLOM was attributable to the Collaboration Agreement and was included as an offset against the research and development expense in the condensed consolidated statement of operations for the three months ending June 30, 2021. Innovent Biologics (Suzhou) Co., Ltd. (the “rituximab Licensed Product” and together with the bevacizumab Licensed Product, the “Innovent Licensed Products”) in the Territory. Under the License Agreement, the Company committed to pay Innovent a $5.0 million upfront payment and an aggregate of up to $40.0 million in milestone payments in connection with the achievement of certain development, regulatory and sales milestones with respect to the bevacizumab Licensed Product and, if the Company’s option was exercised, an aggregate of up to $40.0 million in milestone payments in connection with the achievement of certain development, regulatory and sales milestones with respect to the rituximab Licensed Product. The Company accounted for the licensing transaction as an asset acquisition under the relevant accounting rules. During the three and six months ended June 30, 2022, the Company’s research and development expense related to bevacizumab Licensed Product development activities directly with Innovent was immaterial. During the three and six months ended June 30, 2021, the Company recognized research and development expense of $3.3 million and $6.6 million, respectively, related to bevacizumab Licensed Product development activities. On May 3, 2022, the Company provided notice of termination of the License Agreement to Innovent pursuant to Section 13.6 of the License Agreement. In connection therewith, the Company has discontinued development of the bevacizumab Licensed Product. Bioeq On November 4, 2019, the Company entered into a license agreement with Bioeq 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 this agreement, Bioeq granted to the Company an exclusive, royalty-bearing license to commercialize the Bioeq Licensed Products in the field of ophthalmology (and any other approved labelled indication) in the United States. Bioeq will supply to the Company the Bioeq Licensed Products in accordance with terms and conditions specified in the agreement and a manufacturing and supply agreement to be executed by the parties in accordance therewith. The agreement’s initial term continues in effect for ten years after the first commercial sale of a Bioeq Licensed Product in the United States, and thereafter renews for an unlimited period of time unless otherwise terminated in accordance with its terms. Under the agreement, Bioeq must use commercially reasonable efforts to develop and obtain regulatory approval of the Bioeq Licensed Products in the United States in accordance with a development and manufacturing plan, and the Company must use commercially reasonable efforts to commercialize the Bioeq Licensed Products in accordance with a commercialization plan. Additionally, the Company must commit certain pre-launch and post-launch resources to the commercialization of the Bioeq Licensed Products for a limited time as specified in the agreement. The Company accounted for the licensing transaction as an asset acquisition under the relevant accounting rules. The Company paid Bioeq an upfront and a milestone payment aggregating to €10 million ($11.1 million), which was recorded as research and development expense in the Company’s consolidated statement of operations in 2019. The Company is obligated to pay Bioeq an aggregate of up to €12.5 million in additional milestone payments in connection with the achievement of certain development and regulatory milestones with respect to the Bioeq Licensed Products in the United States. The Company will share a percentage of gross profits on sales of Bioeq Licensed Products in the United States with Bioeq in the low to mid fifty percent range. The additional milestone payments and royalties are contingent upon future events and, therefore, will be recorded when it is probable that a milestone will be achieved or when royalties are incurred. As of June 30, 2022, the Company did not have any outstanding obligations for milestones or royalties to Bioeq. On August 2, 2022, the FDA approved the CHS-201 Section 351(k) BLA (see Note 12). With this regulatory approval, and subject to satisfaction of certain additional manufacturing and supply criteria prior to December 31, 2022, the Company will be required to pay Bioeq a milestone payment of €2.5 million. |
Debt Obligations
Debt Obligations | 6 Months Ended |
Jun. 30, 2022 | |
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 June 30, 2022 (in thousands) Principal Amount Unamortized Debt Discount and Debt Issuance Costs Net Carrying Value Estimated Fair Value Level Financial Liabilities: 2027 Term Loans $ 200,000 $ (3,963) $ 196,037 $ 196,037 Level 2* 2026 Convertible Notes $ 230,000 $ (5,072) $ 224,928 $ 151,211 Level 2 At December 31, 2021 (in thousands) Principal Amount Unamortized Exit Fee, Debt Discount and Debt Issuance Costs Net Carrying Value Estimated Fair Value Level Financial Liabilities: 2026 Convertible Notes $ 230,000 $ (5,712) $ 224,288 $ 271,860 Level 2 2022 Convertible Notes $ 109,000 $ (521) $ 108,479 $ 108,361 Level 3 2025 Term Loan $ 75,000 $ 513 $ 75,513 $ 75,513 Level 2* * The principal amount outstanding is subject to a variable interest rate, which is based on the three-month LIBOR plus a fixed percentage. Therefore, the Company believes the carrying amount of these obligations approximates fair value. 2027 Term Loans The Company entered into a loan agreement (including as subsequently amended, 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”) to be funded at the Company’s option between April 1, 2022 and March 17, 2023, subject to certain conditions including the first FDA approval of a BLA for the Company’s product candidate toripalimab in the United States; 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”) to be funded at the Company’s option between April 1, 2022 and March 17, 2023, subject to certain conditions including the first FDA approval of a BLA for the Company’s product CIMERLI, a ranibizumab (Lucentis) biosimilar, in the United States, which was obtained on August 2, 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 bear interest at 8.25% plus three-month LIBOR per annum with a LIBOR floor of 1.0%; the interest rate for the second quarter of 2022 was 9.25%. In the event of the cessation of LIBOR, the benchmark governing the interest rate will be replaced with a rate based on the secured overnight financing rate published by the Federal Reserve Bank of New York as described in the Loan Agreement. Interest is payable quarterly in arrears on March 31, June 30, September 30 and December 31 of each year. Repayment of outstanding principal of the 2027 Term Loans will be made in five equal quarterly payments of principal commencing March 31, 2026. The Company adopted the prospective method to account for future cash payments. Under the prospective method, the effective interest rate is not constant, and any change in the expected cash flows is recognized prospectively as an adjustment to the effective yield. The obligations under the Loan Agreement are secured pursuant to customary security documentation, including a guaranty and security agreement among the Credit Parties and the Collateral Agent which provides for a lien on substantially all of the Company’s tangible and intangible assets and property, including intellectual property. Pursuant to the Loan Agreement, and subject to certain restrictions, proceeds of the 2027 Term Loans were and will be used to fund the Company’s general corporate and working capital requirements except for the following: in January 2022, proceeds of the Tranche A Loan were used to repay in full all amounts outstanding under the 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 June 30, 2022, the Company was in full compliance with these covenants and there were no events of default under the 2027 Term Loans. In connection with the closing of Tranche A, the Company incurred $7.8 million in debt discounts and issuance costs The following table presents the components of interest expense related to the 2027 Term Loans: Three Months Ended Six Months Ended June 30, June 30, (in thousands) 2022 2022 Stated coupon interest $ 4,702 $ 6,912 Amortization of debt discount and debt issuance costs 659 3,500 Total interest expense $ 5,361 $ 10,412 Future payments on the 2027 Term Loans as of June 30, 2022 are as follows: Year ending December 31, (in thousands) Remainder of 2022 - interest only $ 9,456 2023 - interest only 18,757 2024 - interest only 18,808 2025 - interest only 18,757 2026 and thereafter 213,145 Total minimum payments 278,923 Less amount representing interest (78,923) 2027 Term Loans, gross 200,000 Less unamortized debt discount and debt issuance costs, net (3,963) Net carrying amount of 2027 Term Loans $ 196,037 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. The initial conversion rate is 51.9224 shares of common stock per $1,000 principal amount of the 2026 Convertible Notes, which represents an initial conversion price of approximately $19.26 per share of common stock. The initial conversion price represents a premium of approximately 30.0% over the last reported sale of $14.815 per share of the Company’s common stock on the Nasdaq Global Market on April 14, 2020, the date the 2026 Convertible Notes were issued. The conversion rate and conversion price will be subject to customary adjustments upon the occurrence of certain events. If a “make-whole fundamental change” (as defined in the indenture for the 2026 Convertible Notes) occurs, the Company will, in certain circumstances, increase the conversion rate for a specified period of time for noteholders who convert their 2026 Convertible Notes in connection with that make-whole fundamental change. The 2026 Convertible Notes are not redeemable at the Company’s election before maturity. If a “fundamental change” (as defined in the indenture for the 2026 Convertible Notes) occurs, then, subject to a limited exception, noteholders may require the Company to repurchase their 2026 Convertible Notes for cash. The repurchase price will be equal to the principal amount of the 2026 Convertible Notes to be repurchased, plus accrued and unpaid interest, if any, to, but excluding, the applicable repurchase date. The 2026 Convertible Notes have customary provisions relating to the occurrence of “events of default” (as defined in the Indenture for the 2026 Convertible Notes). The occurrence of such events of default could result in the acceleration of all amounts due under the 2026 Convertible Notes. As of June 30, 2022, the Company was in full compliance with these covenants and there were no events of default under the 2026 Convertible Notes. The Company evaluated the features embedded in the 2026 Convertible Notes under the relevant accounting rules and concluded that the embedded features do not meet the requirements for bifurcation, and therefore do not need to be separately accounted for as an equity component. The proceeds received from the issuance of the convertible debt were recorded as a liability 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 “option counterparties”). The capped call transactions are generally expected to reduce the potential dilution upon conversion of the 2026 Convertible Notes in the event that the market price per share of the Company’s common stock, as measured under the terms of the capped call transactions, is greater than the strike price of the capped call transactions, which initially corresponds to the conversion price of the 2026 Convertible Notes, and is subject to anti-dilution adjustments generally similar to those applicable to the conversion rate of the 2026 Convertible Notes. The cap price of the capped call transactions will initially be $25.9263 per share, which represents a premium of approximately 75.0% over the last reported sale price of the Company’s common stock of $14.815 per share on April 14, 2020, and is subject to certain adjustments under the terms of the capped call transactions. The capped call transactions are accounted for as separate transactions from the 2026 Convertible Notes and classified as equity instruments; thus, they are recorded as a reduction to additional paid-in capital on the condensed consolidated balance sheets. If the 2026 Convertible Notes were converted on June 30, 2022, the holders of the 2026 Convertible Notes would have received common shares with an aggregate value of $86.5 million based on the Company’s closing stock price of $7.24. 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. The remaining unamortized debt discount and debt offering costs related to the Company’s 2026 Convertible Notes of $5.1 million as of June 30, 2022, 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. The following table presents the components of interest expense related to 2026 Convertible Notes: Three Months Ended Six Months Ended June 30, June 30, (in thousands) 2022 2021 2022 2021 Stated coupon interest $ 862 $ 862 $ 1,725 $ 1,725 Amortization of debt discount and debt issuance costs 321 314 640 626 Total interest expense $ 1,183 $ 1,176 $ 2,365 $ 2,351 Future payments on the 2026 Convertible Notes as of June 30, 2022 are as follows: Year ending December 31, (in thousands) Remainder of 2022 - interest only $ 1,725 2023 - interest only 3,450 2024 - interest only 3,450 2025 - interest only 3,450 2026 and thereafter 231,725 Total minimum payments 243,800 Less amount representing interest (13,800) 2026 Convertible Notes, principal amount 230,000 Less debt discount and debt issuance costs on 2026 Convertible Notes (5,072) Net carrying amount of 2026 Convertible Notes $ 224,928 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. The 2022 Convertible Notes constituted general, senior unsubordinated obligations of the Company and were guaranteed by certain subsidiaries of the Company. The 2022 Convertible Notes bore interest at a fixed coupon rate of 8.2% per annum payable quarterly in arrears on March 31, June 30, September 30 and December 31 of each year, since March 31, 2016, and matured on March 31, 2022. The 2022 Convertible Notes also had a premium of 9% of its principal amount, payable when the 2022 Convertible Notes matured or were repurchased or redeemed by the Company. In March 2022, the Company fully repaid, and a s a result has no continuing obligations associated with, The following table presents the components of interest expense related to the 2022 Convertible Notes: Three Months Ended Six Months Ended June 30, June 30, (in thousands) 2022 2021 2022 2021 Stated coupon interest $ — $ 2,050 $ 2,050 $ 4,100 Amortization of debt discount and debt issuance costs — 485 521 960 Total interest expense $ — $ 2,535 $ 2,571 $ 5,060 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”). Starting January 1, 2020, the Borrowings under the 2025 Term Loan bore interest at 6.75% per annum plus three-month LIBOR. Interest was payable quarterly in arrears. Pursuant to the terms of the 2025 Term Loan, the Company was required to begin paying principal on the Borrowings in equal quarterly installments beginning on the Loan totaled $6.2 million and was recorded in loss on debt extinguishment in the condensed consolidated statement of operations for the six months ended June 30, 2022. As of June 30, 2022, the Company had no continuing obligations associated with the 2025 Term Loan. The following table presents the components of interest expense related to the 2025 Term Loan: Three Months Ended Six Months Ended June 30, June 30, (in thousands) 2022 2021 2022 2021 Stated coupon interest $ — $ 1,754 $ 154 $ 3,488 Amortization of debt discount and debt issuance costs — 263 16 478 Total interest expense $ — $ 2,017 $ 170 $ 3,966 |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2022 | |
Commitments and Contingencies. | |
Commitments and Contingencies | 8. Commitments and Contingencies Purchase Commitments The Company entered into agreements with certain vendors to secure raw materials and certain CMOs to manufacture its supply of products. As of June 30, 2022, the Company’s contractual obligations under the terms of the agreements are as follows: Years ending December 31, (in thousands) Remainder of 2022 $ 25,539 2023 16,327 2024 911 2025 911 2026 208 Total obligations $ 43,896 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 other claims that arise in the ordinary, routine course of business and that have not been fully resolved. The most significant of these are described below. The outcome of such legal proceedings and other claims is inherently uncertain. Accruals are recognized for such legal proceedings and other 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. The Company did not have any accruals related to such matters on the condensed consolidated balance sheets as of June 30, 2022 and December 31, 2021, respectively. In late April of 2022, the Company received a demand letter from Zinc Health Services, LLC (“Zinc”) asserting Zinc was entitled to approximately $14 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 is unable to reasonably estimate the amount or range of loss that may be incurred, if any, in connection with this matter. At this time, the Company has not made an accrual in connection with this matter. Other than the matter in connection with the demand letter described in this Note 8, there are no material pending legal proceedings or other claims, 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. |
Stock-Based Compensation
Stock-Based Compensation | 6 Months Ended |
Jun. 30, 2022 | |
Stock-Based Compensation | |
Stock-Based Compensation | 9. 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 Six Months Ended June 30, June 30, (in thousands) 2022 2021 2022 2021 Cost of goods sold (1) $ 216 $ 311 $ 371 $ 502 Research and development 4,576 4,084 9,534 10,516 Selling, general and administrative 9,058 7,200 16,824 17,461 Stock-based compensation expense $ 13,850 $ 11,595 $ 26,729 $ 28,479 Capitalized stock-based compensation expense into inventory $ 301 $ 228 $ 614 $ 417 (1) Stock-based compensation capitalized into inventory is recognized as cost of goods sold when the related product is sold . |
Net Loss Per Share
Net Loss Per Share | 6 Months Ended |
Jun. 30, 2022 | |
Net Loss Per Share | |
Net Loss Per Share | 10. 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 Six Months Ended June 30, June 30, 2022 2021 2022 2021 Stock options, including shares subject to ESPP 22,195,040 19,099,431 22,133,745 19,072,986 Restricted stock units 2,420,078 1,820,247 2,449,703 1,820,247 Shares issuable upon conversion of 2022 Convertible Notes — 4,473,871 2,175,142 4,473,871 Shares issuable upon conversion of 2026 Convertible Notes 11,942,152 11,942,152 11,942,152 11,942,152 Total 36,557,270 37,335,701 38,700,741 37,309,256 |
Related Party Transactions
Related Party Transactions | 6 Months Ended |
Jun. 30, 2022 | |
Related Party Transactions | |
Related Party Transactions | 11. Related Party Transactions Consulting services In October 2020, the Company entered into a consulting agreement with Lanfear Advisors owned by Jonathan Lanfear who is the brother of Dennis Lanfear, the Company’s President, Chief Executive Officer and Chairman of the Board of Directors. Jonathan Lanfear provided consulting services with respect to the Collaboration Agreement executed with Junshi Biosciences in February 2021 (See Note 6). In addition to the hourly consulting fee paid to Lanfear Advisors under the consulting agreement, the Company granted fully vested stock options to purchase 65,000 shares of common stock with an exercise price of $17.60 per share to Jonathan Lanfear in February 2021 upon the execution of the Collaboration Agreement with Junshi Biosciences. During the first quarter of 2021, the Company recognized non-cash stock-based compensation expense of $0.8 million and consulting service expense of $0.2 million related to these services. Subsequent to this, no material related party expenses have been recorded. Total liabilities recognized on the condensed consolidated balance sheets with respect to these services were immaterial as of June 30, 2022 and December 31, 2021. |
Subsequent Events
Subsequent Events | 6 Months Ended |
Jun. 30, 2022 | |
Subsequent Events | |
Subsequent Events | 12. Subsequent Event On August 2, 2022, the FDA approved CIMERLI (ranibizumab-eqrn) as a biosimilar product interchangeable with Lucentis (ranibizumab injection) for all five indications, with 12 months of interchangeability exclusivity. Commercial launch of CIMERLI, in both 0.3 mg and 0.5 mg dosage forms, is planned for early October 2022 |
Organization and Summary of S_2
Organization and Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2022 | |
Organization and Summary of Significant Accounting Policies | |
Basis of Consolidation | Basis of Consolidation The accompanying unaudited condensed consolidated financial statements include the accounts of Coherus and its wholly owned subsidiaries. All intercompany transactions and balances have been eliminated upon consolidation. The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with United States generally accepted accounting principles (“U.S. GAAP”) for interim financial information and in accordance with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X of the Securities Act of 1933, as amended (the “Securities Act”). Accordingly, they do not include all of the information and notes required by U.S. GAAP for complete financial statements. These unaudited condensed consolidated financial statements reflect all adjustments, including normal recurring accruals, that the Company believes are necessary to fairly state the financial position and the results of the Company’s operations and cash flows for interim periods in accordance with U.S. GAAP. Interim-period results are not necessarily indicative of results of operations or cash flows for a full year or any subsequent interim period. The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the Company’s audited financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021 (the “2021 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 for the six months ended June 30, 2022 and 2021: (in thousands) At January 1, At beginning of period: 2022 2021 Cash and cash equivalents $ 417,195 $ 541,158 Restricted cash 440 440 Total cash, cash equivalents and restricted cash $ 417,635 $ 541,598 At June 30, At end of period: 2022 2021 Cash and cash equivalents $ 275,484 $ 329,738 Restricted cash 440 440 Total cash, cash equivalents and restricted cash $ 275,924 $ 330,178 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 | Investments in Marketable Securities Investments in marketable securities primarily consist of corporate debt obligations and commercial paper. Management determines the appropriate classification of investments in marketable securities at the time of purchase based upon management’s intent with regards to such investment and reevaluates such designation as of each balance sheet date. The Company’s investment policy requires that it only invests in highly rated securities and limit its exposure to any single issuer. All investments in debt marketable securities are held as “available-for-sale” and are carried at the estimated fair value as determined based upon quoted market prices or pricing models for similar securities. The Company classifies investments in marketable securities as short-term when they have remaining contractual maturities of one year or less from the balance sheet date. Unrealized gains and losses on available-for-sale securities are reported as a component of accumulated comprehensive income (loss), with the exception of unrealized losses believed to be related to credit losses, if any, which are recognized in earnings in the period the impairment occurs. Impairment assessments are made at the individual security level each reporting period. When the fair value of an investment is less than its cost at the balance sheet date, a determination is made as to whether the impairment is related to a credit loss and, if it is, the portion of the impairment relating to credit loss is recorded as an allowance through net income. Realized gains and losses on available-for-sale securities are included in other income, net, 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 June 30, 2022 and December 31, 2021. |
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 Summary of S_3
Organization and Summary of Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Organization and Summary of Significant Accounting Policies | |
Schedule of Reconciliation of Cash, Cash Equivalents and Restricted Cash | The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheets which, in aggregate, represent the amount reported in the condensed consolidated statements of cash flows for the six months ended June 30, 2022 and 2021: (in thousands) At January 1, At beginning of period: 2022 2021 Cash and cash equivalents $ 417,195 $ 541,158 Restricted cash 440 440 Total cash, cash equivalents and restricted cash $ 417,635 $ 541,598 At June 30, At end of period: 2022 2021 Cash and cash equivalents $ 275,484 $ 329,738 Restricted cash 440 440 Total cash, cash equivalents and restricted cash $ 275,924 $ 330,178 |
Revenue (Tables)
Revenue (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Revenue | |
Gross Revenues by Significant Customer as a Percentage of Total Gross Revenues | Gross revenues by significant customer as a percentage of total gross revenues are as follows: Three Months Ended Six Months Ended June 30, 2022 June 30, 2021 June 30, 2022 June 30, 2021 McKesson Corporation 36 % 39 % 37 % 39 % AmeriSource-Bergen Corporation 46 % 38 % 45 % 38 % Cardinal Health, Inc. 17 % 22 % 17 % 21 % |
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: Six Months Ended June 30, 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 220,178 38,075 39,353 297,606 Prior period (2,147) (3,165) (556) (5,868) Payments and customer credits issued (216,130) (44,816) (44,402) (305,348) Balances at June 30, 2022 $ 31,566 $ 44,098 $ 20,449 $ 96,113 Six Months Ended June 30, 2021 Chargebacks Other Fees, and Discounts Co-pay for Prompt Assistance (in thousands) Payment Rebates and Returns Total Balances at December 31, 2020 $ 40,580 $ 54,058 $ 28,760 $ 123,398 Provision related to sales made in: Current period 237,745 61,190 50,039 348,974 Prior period (2,850) (1,890) (2,818) (7,558) Payments and customer credits issued (247,641) (52,213) (50,726) (350,580) Balances at June 30, 2021 $ 27,834 $ 61,145 $ 25,255 $ 114,234 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Fair Value Measurements | |
Financial Assets and Liabilities Measured on a Recurring Basis | Financial assets and liabilities subject to fair value measurements on a recurring basis and the level of inputs used in such measurements were as follows: Fair Value Measurements June 30, 2022 (in thousands) Level 1 Level 2 Level 3 Total Financial Assets: Cash and cash equivalents (money market funds) $ 275,484 $ — $ — $ 275,484 Restricted cash (money market funds) 440 — — 440 Total financial assets $ 275,924 $ — $ — $ 275,924 Fair Value Measurements December 31, 2021 (in thousands) Level 1 Level 2 Level 3 Total Financial Assets: Cash and cash equivalents (money market funds) $ 417,165 $ — $ — $ 417,165 Restricted cash (money market funds) 440 — — 440 Total financial assets $ 417,605 $ — $ — $ 417,605 |
Inventory (Tables)
Inventory (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Inventory | |
Schedule of Inventory | Inventory consisted of the following: June 30, December 31, (in thousands) 2022 2021 Raw materials $ 7,685 $ 4,870 Work in process 69,593 65,117 Finished goods 30,420 23,265 Total $ 107,698 $ 93,252 |
Schedule of Balance Sheet Classification | June 30, December 31, (in thousands) 2022 2021 Inventory $ 31,744 $ 37,642 Inventory, non-current 75,954 55,610 Total $ 107,698 $ 93,252 |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Organization and Operations | |
Schedule of Property and Equipment, Net | Property and equipment, net consists of the following: June 30, December 31, (in thousands) 2022 2021 Machinery and equipment $ 12,564 $ 11,876 Computer equipment and software 3,052 3,033 Furniture and fixtures 1,161 1,129 Leasehold improvements 6,145 5,942 Finance lease right of use assets 4,223 2,294 Construction in progress 788 388 Total property and equipment 27,933 24,662 Accumulated depreciation and amortization (18,380) (16,849) Property and equipment, net $ 9,553 $ 7,813 |
Schedule of Accrued Liabilities | Accrued and other current liabilities are summarized as follows: June 30, December 31, (in thousands) 2022 2021 Accrued manufacturing and clinical $ 14,781 $ 30,541 Accrued co-development costs for toripalimab 12,025 1,926 Lease liabilities, current 3,988 3,492 Accrued other 10,999 12,168 Total Accrued and other current liabilities $ 41,793 $ 48,127 |
Debt Obligations (Tables)
Debt Obligations (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
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 June 30, 2022 (in thousands) Principal Amount Unamortized Debt Discount and Debt Issuance Costs Net Carrying Value Estimated Fair Value Level Financial Liabilities: 2027 Term Loans $ 200,000 $ (3,963) $ 196,037 $ 196,037 Level 2* 2026 Convertible Notes $ 230,000 $ (5,072) $ 224,928 $ 151,211 Level 2 At December 31, 2021 (in thousands) Principal Amount Unamortized Exit Fee, Debt Discount and Debt Issuance Costs Net Carrying Value Estimated Fair Value Level Financial Liabilities: 2026 Convertible Notes $ 230,000 $ (5,712) $ 224,288 $ 271,860 Level 2 2022 Convertible Notes $ 109,000 $ (521) $ 108,479 $ 108,361 Level 3 2025 Term Loan $ 75,000 $ 513 $ 75,513 $ 75,513 Level 2* * The principal amount outstanding is subject to a variable interest rate, which is based on the three-month LIBOR plus a fixed percentage. Therefore, the Company believes the carrying amount of these obligations approximates fair value. |
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 Six Months Ended June 30, June 30, (in thousands) 2022 2022 Stated coupon interest $ 4,702 $ 6,912 Amortization of debt discount and debt issuance costs 659 3,500 Total interest expense $ 5,361 $ 10,412 |
Schedule of Future Payments on Debt | Future payments on the 2027 Term Loans as of June 30, 2022 are as follows: Year ending December 31, (in thousands) Remainder of 2022 - interest only $ 9,456 2023 - interest only 18,757 2024 - interest only 18,808 2025 - interest only 18,757 2026 and thereafter 213,145 Total minimum payments 278,923 Less amount representing interest (78,923) 2027 Term Loans, gross 200,000 Less unamortized debt discount and debt issuance costs, net (3,963) Net carrying amount of 2027 Term Loans $ 196,037 |
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 2026 Convertible Notes: Three Months Ended Six Months Ended June 30, June 30, (in thousands) 2022 2021 2022 2021 Stated coupon interest $ 862 $ 862 $ 1,725 $ 1,725 Amortization of debt discount and debt issuance costs 321 314 640 626 Total interest expense $ 1,183 $ 1,176 $ 2,365 $ 2,351 |
Schedule of Future Payments on Debt | Future payments on the 2026 Convertible Notes as of June 30, 2022 are as follows: Year ending December 31, (in thousands) Remainder of 2022 - interest only $ 1,725 2023 - interest only 3,450 2024 - interest only 3,450 2025 - interest only 3,450 2026 and thereafter 231,725 Total minimum payments 243,800 Less amount representing interest (13,800) 2026 Convertible Notes, principal amount 230,000 Less debt discount and debt issuance costs on 2026 Convertible Notes (5,072) Net carrying amount of 2026 Convertible Notes $ 224,928 |
8.2% Convertible Notes due 2022 | |
Debt Instrument | |
Components of Interest Expense | The following table presents the components of interest expense related to the 2022 Convertible Notes: Three Months Ended Six Months Ended June 30, June 30, (in thousands) 2022 2021 2022 2021 Stated coupon interest $ — $ 2,050 $ 2,050 $ 4,100 Amortization of debt discount and debt issuance costs — 485 521 960 Total interest expense $ — $ 2,535 $ 2,571 $ 5,060 |
2025 Term Loan | |
Debt Instrument | |
Components of Interest Expense | The following table presents the components of interest expense related to the 2025 Term Loan: Three Months Ended Six Months Ended June 30, June 30, (in thousands) 2022 2021 2022 2021 Stated coupon interest $ — $ 1,754 $ 154 $ 3,488 Amortization of debt discount and debt issuance costs — 263 16 478 Total interest expense $ — $ 2,017 $ 170 $ 3,966 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Commitments and Contingencies. | |
Schedule of Non-cancelable Contractual Obligations | Years ending December 31, (in thousands) Remainder of 2022 $ 25,539 2023 16,327 2024 911 2025 911 2026 208 Total obligations $ 43,896 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
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 Six Months Ended June 30, June 30, (in thousands) 2022 2021 2022 2021 Cost of goods sold (1) $ 216 $ 311 $ 371 $ 502 Research and development 4,576 4,084 9,534 10,516 Selling, general and administrative 9,058 7,200 16,824 17,461 Stock-based compensation expense $ 13,850 $ 11,595 $ 26,729 $ 28,479 Capitalized stock-based compensation expense into inventory $ 301 $ 228 $ 614 $ 417 (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) | 6 Months Ended |
Jun. 30, 2022 | |
Net Loss Per Share | |
Outstanding Dilutive Potential Shares Excluded from Calculation of Diluted Net (loss) Income Per Share | The following outstanding dilutive potential shares were excluded from the calculation of diluted net loss per share due to their anti-dilutive effect: Three Months Ended Six Months Ended June 30, June 30, 2022 2021 2022 2021 Stock options, including shares subject to ESPP 22,195,040 19,099,431 22,133,745 19,072,986 Restricted stock units 2,420,078 1,820,247 2,449,703 1,820,247 Shares issuable upon conversion of 2022 Convertible Notes — 4,473,871 2,175,142 4,473,871 Shares issuable upon conversion of 2026 Convertible Notes 11,942,152 11,942,152 11,942,152 11,942,152 Total 36,557,270 37,335,701 38,700,741 37,309,256 |
Organization and Significant Ac
Organization and Significant Accounting Policies - Organization (Details) | 6 Months Ended |
Jun. 30, 2022 product | |
Organization and Summary of Significant Accounting Policies | |
Number of wholly-owned preclinical immuno-oncology programs | 2 |
Product pipeline, number of drug candidates | 4 |
Organization and Significant _2
Organization and Significant Accounting Policies - Cash, Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 | Jun. 30, 2021 | Dec. 31, 2020 |
Organization and Summary of Significant Accounting Policies | ||||
Cash and cash equivalents | $ 275,484 | $ 417,195 | $ 329,738 | $ 541,158 |
Restricted Cash | 440 | 440 | 440 | 440 |
Total cash, cash equivalents and restricted cash | $ 275,924 | $ 417,635 | $ 330,178 | $ 541,598 |
Revenue - Additional Informatio
Revenue - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Revenue | ||||
Net revenue | $ 60,151 | $ 87,643 | $ 120,266 | $ 170,677 |
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 | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
McKesson | ||||
Concentration Risk | ||||
Percentage of total gross revenue | 36% | 39% | 37% | 39% |
AmeriSource-Bergen Corp | ||||
Concentration Risk | ||||
Percentage of total gross revenue | 46% | 38% | 45% | 38% |
Cardinal | ||||
Concentration Risk | ||||
Percentage of total gross revenue | 17% | 22% | 17% | 21% |
Revenue - Activities and Ending
Revenue - Activities and Ending Reserve Balances for Each Significant Category of Discounts and Allowances (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Accounts Notes And Loans Receivable | ||
Activities and reserve balance, beginning balance | $ 109,723 | $ 123,398 |
Provision related to sales made in: | ||
Current period | 297,606 | 348,974 |
Prior period | (5,868) | (7,558) |
Payments and customer credits issued | (305,348) | (350,580) |
Activities and reserve balance, ending balance | 96,113 | 114,234 |
Chargebacks and Discounts for Prompt Payment | ||
Accounts Notes And Loans Receivable | ||
Activities and reserve balance, beginning balance | 29,665 | 40,580 |
Provision related to sales made in: | ||
Current period | 220,178 | 237,745 |
Prior period | (2,147) | (2,850) |
Payments and customer credits issued | (216,130) | (247,641) |
Activities and reserve balance, ending balance | 31,566 | 27,834 |
Rebates | ||
Accounts Notes And Loans Receivable | ||
Activities and reserve balance, beginning balance | 54,004 | 54,058 |
Provision related to sales made in: | ||
Current period | 38,075 | 61,190 |
Prior period | (3,165) | (1,890) |
Payments and customer credits issued | (44,816) | (52,213) |
Activities and reserve balance, ending balance | 44,098 | 61,145 |
Other Fees, Co-pay Assistance and Returns | ||
Accounts Notes And Loans Receivable | ||
Activities and reserve balance, beginning balance | 26,054 | 28,760 |
Provision related to sales made in: | ||
Current period | 39,353 | 50,039 |
Prior period | (556) | (2,818) |
Payments and customer credits issued | (44,402) | (50,726) |
Activities and reserve balance, ending balance | $ 20,449 | $ 25,255 |
Fair Value Measurements - Finan
Fair Value Measurements - Financial Assets and Liabilities Measured on a Recurring Basis (Details) - Fair Value Measurements Recurring Basis - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | $ 275,924 | $ 417,605 |
Level 1 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 275,924 | 417,605 |
Level 2 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 0 | |
Level 3 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 0 | |
Cash and cash equivalents (money market funds) | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 275,484 | 417,165 |
Cash and cash equivalents (money market funds) | Level 1 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 275,484 | 417,165 |
Cash and cash equivalents (money market funds) | Level 2 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 0 | |
Cash and cash equivalents (money market funds) | Level 3 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 0 | |
Restricted Cash (Money Market Funds) | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 440 | 440 |
Restricted Cash (Money Market Funds) | Level 1 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 440 | $ 440 |
Restricted Cash (Money Market Funds) | Level 2 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 0 | |
Restricted Cash (Money Market Funds) | Level 3 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | $ 0 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) - USD ($) $ in Millions | 6 Months Ended | 12 Months Ended |
Jun. 30, 2022 | Dec. 31, 2021 | |
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 |
Inventory (Details)
Inventory (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Inventory | ||
Raw materials | $ 7,685 | $ 4,870 |
Work in process | 69,593 | 65,117 |
Finished goods | 30,420 | 23,265 |
Total | $ 107,698 | $ 93,252 |
Inventory - Balance Sheet Class
Inventory - Balance Sheet Classifications (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Inventory | ||
Inventory | $ 31,744 | $ 37,642 |
Inventory, non-current | 75,954 | 55,610 |
Total | $ 107,698 | $ 93,252 |
Inventory - Additional Informat
Inventory - Additional Information (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2022 | Jun. 30, 2021 | Mar. 31, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | |
Inventory [Line Items] | ||||||
Prepayment made for manufacturing services | $ 7,176,000 | $ 7,176,000 | $ 13,666,000 | |||
Other assets, non-current | 10,149,000 | 10,149,000 | 10,025,000 | |||
Inventory | 31,744,000 | 31,744,000 | 37,642,000 | |||
Impairment charge within research and development expenses | $ 0 | $ 3,200,000 | $ 3,210,000 | |||
Research and development | 41,611,000 | $ 54,766,000 | 124,528,000 | $ 258,258,000 | ||
Prepayments made to a CMO for manufacturing services for UDENYCA | 3,500,000 | 3,500,000 | 8,300,000 | |||
Prepayments made to a CMO For Other Research And Development Pipeline Program | 3,700,000 | 3,700,000 | $ 5,400,000 | |||
Yusimry Product [Member] | ||||||
Inventory [Line Items] | ||||||
Inventory | $ 1,900,000 | $ 1,900,000 | ||||
CHS-2020 | ||||||
Inventory [Line Items] | ||||||
Research and development | $ 11,500,000 |
Balance Sheet Components - Sche
Balance Sheet Components - Schedule of Property and Equipment, Net (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Property and Equipment, Net | ||
Total property and equipment | $ 27,933 | $ 24,662 |
Accumulated depreciation and amortization | (18,380) | (16,849) |
Property and equipment, net | 9,553 | 7,813 |
Machinery and Equipment | ||
Property and Equipment, Net | ||
Total property and equipment | 12,564 | 11,876 |
Computer Equipment and Software | ||
Property and Equipment, Net | ||
Total property and equipment | 3,052 | 3,033 |
Furniture and Fixtures | ||
Property and Equipment, Net | ||
Total property and equipment | 1,161 | 1,129 |
Leasehold Improvements | ||
Property and Equipment, Net | ||
Total property and equipment | 6,145 | 5,942 |
Finance lease right of use assets | ||
Property and Equipment, Net | ||
Total property and equipment | 4,223 | 2,294 |
Construction in Progress | ||
Property and Equipment, Net | ||
Total property and equipment | $ 788 | $ 388 |
Balance Sheet Components - Addi
Balance Sheet Components - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Balance Sheet Components | ||||
Depreciation and amortization | $ 900 | $ 900 | $ 1,654 | $ 1,726 |
Balance Sheet Components - Accr
Balance Sheet Components - Accrued and Other Current Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Balance Sheet Components | ||
Accrued manufacturing and clinical | $ 14,781 | $ 30,541 |
Accrued co-development costs for toripalimab | 12,025 | 1,926 |
Lease liabilities, current | 3,988 | 3,492 |
Accrued other | 10,999 | 12,168 |
Total Accrued and other current liabilities | $ 41,793 | $ 48,127 |
Collaborations and Other Arra_2
Collaborations and Other Arrangements (Details) $ / shares in Units, $ in Thousands, € in Millions | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||||||||||||
Apr. 16, 2021 USD ($) $ / shares shares | Feb. 01, 2021 USD ($) item | Jan. 13, 2020 USD ($) | Nov. 04, 2019 EUR (€) | Mar. 31, 2022 USD ($) | Jun. 30, 2022 USD ($) $ / shares | Mar. 31, 2022 USD ($) | Jun. 30, 2021 USD ($) | Mar. 31, 2021 USD ($) | Dec. 31, 2020 USD ($) | Jun. 30, 2022 USD ($) $ / shares | Jun. 30, 2021 USD ($) | Dec. 31, 2019 USD ($) | Dec. 31, 2019 EUR (€) | Aug. 02, 2022 EUR (€) | Dec. 31, 2021 USD ($) $ / shares | Apr. 14, 2020 $ / shares | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions | |||||||||||||||||
Research and development | $ 41,611 | $ 54,766 | $ 124,528 | $ 258,258 | |||||||||||||
Accounts payable | 17,486 | 17,486 | $ 16,159 | ||||||||||||||
Accrued and other current liabilities | $ 41,793 | $ 41,793 | $ 48,127 | ||||||||||||||
License Agreement Fee | $ 35,000 | ||||||||||||||||
Common Stock Par Or Stated Value Per Share | $ / shares | $ 0.0001 | $ 0.0001 | $ 0.0001 | ||||||||||||||
Share Price | $ / shares | $ 7.24 | $ 7.24 | $ 14.815 | ||||||||||||||
Bioeq IP AG | |||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | |||||||||||||||||
Initial term of agreement | 10 years | ||||||||||||||||
Percentage of gross profits shared | 50% | ||||||||||||||||
Bioeq IP AG | Licensed Products | |||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | |||||||||||||||||
Maximum aggregate milestone payments | € | € 12.5 | ||||||||||||||||
Bioeq IP AG | Research and Development Expense | |||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | |||||||||||||||||
Upfront and milestone payment | $ 11,100 | € 10 | |||||||||||||||
Innovent Biologics (Suzhou) Co., Ltd. | |||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | |||||||||||||||||
Research and development | 3,300 | 6,600 | |||||||||||||||
Innovent Biologics (Suzhou) Co., Ltd. | Bevacizumab Licensed Product | |||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | |||||||||||||||||
Collaboration Agreement, upfront amount paid | $ 5,000 | ||||||||||||||||
Maximum aggregate milestone payments | 40,000 | ||||||||||||||||
Innovent Biologics (Suzhou) Co., Ltd. | Rituxan option | |||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | |||||||||||||||||
Maximum aggregate milestone payments | $ 40,000 | ||||||||||||||||
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 | |||||||||||||||
Collaboration Agreement | Research and Development Expense | Anti-TIGIT Antibody and IL-2 cytokine | |||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | |||||||||||||||||
Collaboration Agreement, upfront amount paid | $ 35,000 | ||||||||||||||||
Junshi Biosciences | |||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | |||||||||||||||||
Maximum paid amount for co-development activities (per licensed compound) | $ 25,000 | ||||||||||||||||
Collaboration Agreement, upfront amount paid | $ 5,000 | ||||||||||||||||
Research and development | $ 9,900 | 6,500 | $ 60,000 | 158,200 | |||||||||||||
Undisclosed preclinical | item | 2 | ||||||||||||||||
Collaboration agreement, royalty on net sales for each exercised option, percentage | 18% | ||||||||||||||||
Collaboration agreement, Maximum aggregate one-time payment for achievement of milestones, for each option program | $ 85,000 | ||||||||||||||||
Share Price | $ / shares | $ 20.06 | ||||||||||||||||
Unregistered shares | shares | 2,491,988 | ||||||||||||||||
Aggregate value | $ 50,000 | ||||||||||||||||
Period before the company can sell, transfer or make any short sale of common stock (in years) | 2 years | ||||||||||||||||
Fair value for the discount for lack of marketability (DLOM) | 9,000 | $ 9,000 | |||||||||||||||
Junshi Biosciences | Accrued and other current liabilities | |||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | |||||||||||||||||
Co-development, regulatory and technology transfer costs | $ 12,000 | $ 12,000 | |||||||||||||||
Junshi Biosciences | Toripalimab | |||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | |||||||||||||||||
Collaboration Agreement, upfront amount paid | $ 150,000 | ||||||||||||||||
Collaboration agreement, royalty on net sales, percentage | 20% | ||||||||||||||||
Collaboration agreement, threshold royalty payments | $ 380,000 | ||||||||||||||||
Junshi Biosciences | Research and Development Expense | Toripalimab | |||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | |||||||||||||||||
Collaboration Agreement, upfront amount paid | $ 9,000 | $ 145,000 | |||||||||||||||
Scenario, Plan | Bioeq IP AG | |||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | |||||||||||||||||
Collaboration Agreement, Maximum Payments For Co-development Activities | € | € 2.5 |
Debt Obligations - Summary of D
Debt Obligations - Summary of Debt Obligations (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
2027 Term Loans | Level 2 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Principal amount | $ 200,000 | |
Unamortized debt discount and debt issuance costs | (3,963) | |
Net carrying value | 196,037 | |
Estimated fair value | 196,037 | |
1.5% Convertible Senior Subordinated Notes due 2026 | Level 2 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Principal amount | 230,000 | $ 230,000 |
Unamortized debt discount and debt issuance costs | (5,072) | (5,712) |
Net carrying value | 224,928 | 224,288 |
Estimated fair value | 151,211 | 271,860 |
8.2% Convertible Notes due 2022 | Level 3 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Principal amount | 109,000 | |
Unamortized debt discount and debt issuance costs | (521) | |
Net carrying value | 108,479 | |
Estimated fair value | 108,361 | |
2025 Term Loan | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Net carrying value | $ 0 | |
2025 Term Loan | Level 2 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Principal amount | 75,000 | |
Unamortized debt discount and debt issuance costs | 513 | |
Net carrying value | 75,513 | |
Estimated fair value | $ 75,513 |
Debt Obligations - 2027 Term Lo
Debt Obligations - 2027 Term Loan - Narrative (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||
Mar. 31, 2022 USD ($) | Jan. 31, 2022 USD ($) item | Mar. 31, 2022 USD ($) | Jun. 30, 2022 USD ($) | 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 | BioPharma Credit Investments V GP LLC | |||||||
Debt Instrument [Line Items] | |||||||
Principal amount | $ 300,000 | ||||||
Number of tranches | tranche | 4 | ||||||
Net carrying value | 196,037 | ||||||
Stated interest rate | 8.25% | ||||||
Quarterly payments | item | 5 | ||||||
Loan agreement covenants, minimum trailing twelve month net sales for current quarter | $ 200,000 | ||||||
Loan agreement covenants, minimum trailing twelve month net sales for the quarter ended March 30, 2024 | 210,000 | ||||||
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 | $ 3,963 | ||||||
Effective interest rate | 9.25% | ||||||
2027 Term Loans | BioPharma Credit Investments V GP LLC | Three-month LIBOR | |||||||
Debt Instrument [Line Items] | |||||||
Spread on variable rate | 1% | ||||||
2027 Term Loans | Additional facility amount | BioPharma Credit Investments V GP LLC | |||||||
Debt Instrument [Line Items] | |||||||
Principal amount | $ 100,000 | ||||||
Tranche A Loan, funded January 5, 2022 | BioPharma Credit Investments V GP LLC | |||||||
Debt Instrument [Line Items] | |||||||
Principal amount | $ 100,000 | ||||||
Debt discounts and issuance costs | 7,800 | ||||||
Tranche B Loan, funded no later than April 1, 2022 | BioPharma Credit Investments V GP LLC | |||||||
Debt Instrument [Line Items] | |||||||
Principal amount | $ 100,000 | $ 100,000 | |||||
Debt discounts and issuance costs | 2,300 | ||||||
Convertible notes, Issuance Cost | $ 1,000 | $ 1,000 | |||||
Tranche C Loan, 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 between April 1, 2022 and March 17, 2023 | BioPharma Credit Investments V GP LLC | |||||||
Debt Instrument [Line Items] | |||||||
Principal amount | 50,000 | ||||||
1.5% Convertible Senior Subordinated Notes due 2026 | Convertible Notes | |||||||
Debt Instrument [Line Items] | |||||||
Principal amount | $ 230,000 | ||||||
Net carrying value | $ 224,928 | ||||||
Stated interest rate | 1.50% | ||||||
Remaining unamortized debt discount and debt offering costs | $ 5,072 | ||||||
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 | |||||||
Debt Instrument [Line Items] | |||||||
Net carrying value | $ 0 | ||||||
2025 Term Loan | Convertible Notes | |||||||
Debt Instrument [Line Items] | |||||||
Principal amount | 75,000 | ||||||
Outstanding amount paid off | $ 81,900 | ||||||
Tranche A and B Loans | BioPharma Credit Investments V GP LLC | |||||||
Debt Instrument [Line Items] | |||||||
Remaining unamortized debt discount and debt offering costs | $ 4,000 | ||||||
Remaining term | 4 years 6 months |
Debt Obligations - 2027 Term _2
Debt Obligations - 2027 Term Loans Interest Expense Components (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2022 | Jun. 30, 2021 | |
Debt Instrument [Line Items] | |||
Amortization of debt discount and debt issuance costs | $ 4,677 | $ 2,064 | |
2027 Term Loans | BioPharma Credit Investments V GP LLC | |||
Debt Instrument [Line Items] | |||
Stated coupon interest | $ 4,702 | 6,912 | |
Amortization of debt discount and debt issuance costs | 659 | 3,500 | |
Total Interest expense | $ 5,361 | $ 10,412 |
Debt Obligations - 2027 Term _3
Debt Obligations - 2027 Term Loan Future Payments (Details) - 2027 Term Loans - BioPharma Credit Investments V GP LLC $ in Thousands | Jun. 30, 2022 USD ($) |
Debt Instrument [Line Items] | |
Remainder of 2022 - interest only | $ 9,456 |
2023 - interest only | 18,757 |
2024 - interest only | 18,808 |
2025 - interest only | 18,757 |
2026 and thereafter | 213,145 |
Total minimum payments | 278,923 |
Less amount representing interest | (78,923) |
Term Loan, gross | 200,000 |
Less unamortized debt discount and debt issuance costs, net | (3,963) |
Net carrying amount of Term Loans | $ 196,037 |
Debt Obligations - Convertible
Debt Obligations - Convertible Senior Subordinated Notes due 2026 - Narrative (Details) | 1 Months Ended | 6 Months Ended | |
Apr. 30, 2020 USD ($) $ / shares shares | Jun. 30, 2022 USD ($) $ / shares | Apr. 14, 2020 $ / shares | |
Debt Instrument | |||
Closing stock, price per share | $ / shares | $ 7.24 | $ 14.815 | |
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 June 30, 2022, the Company was in full compliance with these covenants and there were no events of default under the 2026 Convertible Notes. | ||
Debt issuance costs | $ 900,000 | ||
Remaining unamortized debt discount and debt offering costs | $ 5,072,000 | ||
Effective interest rate | 2.10% | ||
Convertible Notes | 1.5% Convertible Senior Subordinated Notes due 2026 | Scenario, Plan | |||
Debt Instrument | |||
Convertible notes, converted amount | $ 86,500,000 |
Debt Obligations - Capped Call
Debt Obligations - Capped Call Transactions - Narrative (Details) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | ||
Apr. 30, 2020 | Jun. 30, 2022 | Apr. 14, 2020 | |
Option Indexed to Issuer's Equity [Line Items] | |||
Closing stock, price per share | $ 7.24 | $ 14.815 | |
Capped Call Transactions in connection with the 2026 Convertible Notes | |||
Option Indexed to Issuer's Equity [Line Items] | |||
Payment for capped call transactions | $ 18.2 | ||
Initial cap price of capped call transactions. | $ 25.9263 | ||
Percentage of cap price | 75% | ||
Closing stock, price per share | $ 14.815 |
Debt Obligations - 2026 Convert
Debt Obligations - 2026 Convertible Notes Interest Expense Components (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Debt Instrument | ||||
Amortization of debt discount and debt issuance costs | $ 4,677 | $ 2,064 | ||
1.5% Convertible Senior Subordinated Notes due 2026 | Convertible Notes | ||||
Debt Instrument | ||||
Stated coupon interest | $ 862 | $ 862 | 1,725 | 1,725 |
Amortization of debt discount and debt issuance costs | 321 | 314 | 640 | 626 |
Total Interest expense | $ 1,183 | $ 1,176 | $ 2,365 | $ 2,351 |
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 | Jun. 30, 2022 USD ($) |
Debt Instrument | |
Remainder of 2022 - interest only | $ 1,725 |
2023 - interest only | 3,450 |
2024 - interest only | 3,450 |
2025 - interest only | 3,450 |
2026 and thereafter | 231,725 |
Total minimum payments | 243,800 |
Less amount representing interest | (13,800) |
2026 Convertible Notes, principal amount | 230,000 |
Less debt discount and debt issuance costs on 2026 Convertible Notes | (5,072) |
Net carrying amount of Term Loans | $ 224,928 |
Debt Obligations - Convertibl_2
Debt Obligations - Convertible Notes due 2022 Narrative (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||
Feb. 29, 2016 | Mar. 31, 2022 | Jan. 31, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Apr. 14, 2020 | |
Debt Instrument | |||||||
Outstanding amount payoff | $ 109,000 | ||||||
Closing stock, price per share | $ 7.24 | $ 14.815 | |||||
Convertible Notes | 8.2% Convertible Notes due 2022 | |||||||
Debt Instrument | |||||||
Principal amount | $ 100,000 | $ 100,000 | |||||
Stated interest rate | 8.20% | 8.20% | |||||
Interest expense | $ 2,535 | $ 2,571 | $ 5,060 | ||||
Interest rate description | The 2022 Convertible Notes bore interest at a fixed coupon rate of 8.2% per annum payable quarterly in arrears on March 31, June 30, September 30 and December 31 of each year, since March 31, 2016 | ||||||
Debt instrument maturity date | Mar. 31, 2022 | ||||||
Outstanding amount payoff | $ 111,100 | $ 111,100 | |||||
Total Convertible Notes | $ 0 | ||||||
Convertible notes, premium percentage | 9% | 9% |
Debt Obligations - 2022 Convert
Debt Obligations - 2022 Convertible Notes Interest Expense Components (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Debt Instrument | ||||
Amortization of debt discount and debt issuance costs | $ 4,677 | $ 2,064 | ||
Total interest expense | $ 6,580 | $ 5,747 | 15,549 | 11,395 |
8.2% Convertible Notes due 2022 | Convertible Notes | ||||
Debt Instrument | ||||
Stated coupon interest | 2,050 | 2,050 | 4,100 | |
Amortization of debt discount and debt issuance costs | 485 | 521 | 960 | |
Total Interest expense | 2,535 | 2,571 | 5,060 | |
1.5% Convertible Senior Subordinated Notes due 2026 | Convertible Notes | ||||
Debt Instrument | ||||
Stated coupon interest | 862 | 862 | 1,725 | 1,725 |
Amortization of debt discount and debt issuance costs | 321 | 314 | 640 | 626 |
Total Interest expense | $ 1,183 | $ 1,176 | $ 2,365 | $ 2,351 |
Debt Obligations - 2025 Term Lo
Debt Obligations - 2025 Term Loan - Narrative (Details) - USD ($) $ in Thousands | 1 Months Ended | 6 Months Ended | |
Jan. 07, 2019 | Jan. 31, 2022 | Jun. 30, 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 | ||
Outstanding amount paid off | $ 81,900 | ||
Stated interest rate | 6.75% | ||
Prepayment premium percentage | 5% | ||
Percentage required to pay an additional exit fee on principal amount | 4% | ||
Loss on debt extinguishment | $ (6,200) |
Debt Obligations - 2025 Term _2
Debt Obligations - 2025 Term Loan Interest Expense Components (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Debt Instrument | |||
Amortization of debt discount and debt issuance costs | $ 4,677 | $ 2,064 | |
Lender | 2025 Term Loan | |||
Debt Instrument | |||
Stated coupon interest | $ 1,754 | 154 | 3,488 |
Amortization of debt discount and debt issuance costs | 263 | 16 | 478 |
Total Interest expense | $ 2,017 | $ 170 | $ 3,966 |
Commitments and Contingencies -
Commitments and Contingencies - Schedule of Non-Cancelable Contractual Obligations (Details) $ in Thousands | Jun. 30, 2022 USD ($) |
Commitments and Contingencies. | |
Remainder of 2022 | $ 25,539 |
2023 | 16,327 |
2024 | 911 |
2025 | 911 |
2026 | 208 |
Total obligations | $ 43,896 |
Commitments and Contingencies_2
Commitments and Contingencies - Additional Information (Details) $ in Millions | 1 Months Ended |
Apr. 30, 2022 USD ($) | |
Contractual Obligation Fiscal Year Maturity [Abstract] | |
Claims related to certain sales of UDENYCA from October 2020 through December 2021 | $ 14 |
Stock-Based Compensation (Detai
Stock-Based Compensation (Details) - Employee And Nonemployee Stock Option And Restricted Stock Units [Member] - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs | ||||
Stock-based compensation expense | $ 13,850 | $ 11,595 | $ 26,729 | $ 28,479 |
Capitalized stock-based compensation expense into inventory | 301 | 228 | 614 | 417 |
Cost of Goods Sold | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs | ||||
Stock-based compensation expense | 216 | 311 | 371 | 502 |
Research and Development Expense | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs | ||||
Stock-based compensation expense | 4,576 | 4,084 | 9,534 | 10,516 |
Selling, General and Administrative Expenses | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs | ||||
Stock-based compensation expense | $ 9,058 | $ 7,200 | $ 16,824 | $ 17,461 |
Net Loss Per Share - Outstandin
Net Loss Per Share - Outstanding Dilutive Potential Shares Excluded from Calculation of Diluted Net (loss) Income Per Share (Details) - shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Antidilutive securities excluded from computation of EPS | ||||
Antidilutive securities excluded from the calculation of diluted net (loss) income per share | 36,557,270 | 37,335,701 | 38,700,741 | 37,309,256 |
Stock options, including shares subject to ESPP | ||||
Antidilutive securities excluded from computation of EPS | ||||
Antidilutive securities excluded from the calculation of diluted net (loss) income per share | 22,195,040 | 19,099,431 | 22,133,745 | 19,072,986 |
Restricted Stock Units | ||||
Antidilutive securities excluded from computation of EPS | ||||
Antidilutive securities excluded from the calculation of diluted net (loss) income per share | 2,420,078 | 1,820,247 | 2,449,703 | 1,820,247 |
8.2% Convertible Notes due 2022 | Shares Issuable Upon Conversion of Convertible Notes | ||||
Antidilutive securities excluded from computation of EPS | ||||
Antidilutive securities excluded from the calculation of diluted net (loss) income per share | 4,473,871 | 2,175,142 | 4,473,871 | |
1.5% Convertible Senior Subordinated Notes due 2026 | Shares Issuable Upon Conversion of Convertible Notes | ||||
Antidilutive securities excluded from computation of EPS | ||||
Antidilutive securities excluded from the calculation of diluted net (loss) income per share | 11,942,152 | 11,942,152 | 11,942,152 | 11,942,152 |
Related Party Transactions (Det
Related Party Transactions (Details) - Consulting Agreement With Lanfear Advisors - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 3 Months Ended | |
Feb. 28, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | |
Related Party Transaction | |||
Number of options, granted | 65,000 | ||
Exercise price | $ 17.60 | ||
Stock-based compensation expense | $ 0.8 | ||
Consulting expense | $ 0 | $ 0.2 |