Document and Entity Information
Document and Entity Information - USD ($) $ in Billions | 12 Months Ended | ||
Dec. 31, 2020 | Jan. 31, 2021 | Jun. 30, 2020 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Document Period End Date | Dec. 31, 2020 | ||
Documents Incorporated by Reference | Part III incorporates by reference certain information from the registrant’s definitive proxy statement for the 2021 Annual Meeting of Stockholders. | ||
Entity File Number | 001-36721 | ||
Entity Registrant Name | Coherus BioSciences, Inc. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 27-3615821 | ||
Entity Address, Address Line One | 333 Twin Dolphin Drive | ||
Entity Address, Address Line Two | Suite 600 | ||
Entity Address, City or Town | Redwood City | ||
Entity Address, State or Province | CA | ||
Entity Address, Postal Zip Code | 94065 | ||
City Area Code | 650 | ||
Local Phone Number | 649 - 3530 | ||
Title of 12(b) Security | Common Stock, $0.0001 par value per share | ||
Trading Symbol | CHRS | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Large Accelerated Filer | ||
ICFR Auditor Attestation Flag | true | ||
Entity Small Business | false | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Common Stock, Shares Outstanding | 72,793,660 | ||
Entity Public Float | $ 0.9 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2020 | ||
Document Fiscal Period Focus | FY | ||
Entity Central Index Key | 0001512762 | ||
Amendment Flag | false |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 541,158 | $ 177,668 |
Trade receivables, net | 157,046 | 141,992 |
Inventory | 44,233 | 9,807 |
Prepaid manufacturing | 19,429 | 8,578 |
Other prepaid and other assets | 5,613 | 4,964 |
Total current assets | 767,479 | 343,009 |
Property and equipment, net | 10,108 | 5,840 |
Inventory, non-current | 47,956 | 45,264 |
Operating lease right-of-use assets | 9,956 | 10,649 |
Intangible assets | 2,620 | 2,620 |
Goodwill | 943 | 943 |
Restricted cash, non-current | 440 | 240 |
Other assets, non-current | 2,147 | 362 |
Total assets | 841,649 | 408,927 |
Current liabilities: | ||
Accounts payable | 15,201 | 25,985 |
Accrued rebates, fees and reserve | 81,529 | 51,120 |
Accrued compensation | 22,244 | 18,410 |
Accrued liabilities | 22,818 | 17,258 |
Other current liabilities | 3,861 | 2,196 |
Total current liabilities | 145,653 | 114,969 |
Contingent consideration, non-current | 102 | 102 |
Convertible notes due 2022 | 79,885 | 78,542 |
Convertible notes due 2022 - related parties | 26,628 | 26,181 |
Convertible notes due 2026 | 223,029 | |
Term loan | 74,481 | 73,663 |
Lease liabilities, non-current | 9,948 | 10,256 |
Other liabilities, non-current | 949 | |
Total liabilities | 560,675 | 303,713 |
Commitments and contingencies (Note 8) | ||
Stockholders' equity: | ||
Common stock ($0.0001 par value; shares authorized: 300,000,000; shares issued and outstanding: 72,513,348 and 70,366,661 at December 31, 2020 and 2019, respectively) | 7 | 7 |
Additional paid-in capital | 1,043,991 | 1,000,763 |
Accumulated other comprehensive loss | (270) | (558) |
Accumulated deficit | (762,754) | (894,998) |
Total stockholders' equity | 280,974 | 105,214 |
Total liabilities and stockholders' equity | $ 841,649 | $ 408,927 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parentheticals) - $ / shares | Dec. 31, 2020 | Dec. 31, 2019 |
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 | 72,513,348 | 70,366,661 |
Common stock, shares outstanding | 72,513,348 | 70,366,661 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Revenue: | |||
Net product revenue | $ 475,824 | $ 356,071 | $ 0 |
Operating expenses: | |||
Cost of goods sold | 37,667 | 17,078 | |
Research and development | 142,759 | 94,188 | 110,239 |
Selling, general and administrative | 139,079 | 137,037 | 94,177 |
Total operating expenses | 319,505 | 248,303 | 204,416 |
Income (loss) from operations | 156,319 | 107,768 | (204,416) |
Interest expense (includes related party expense of $2,498, $2,457 and $2,421 for the years ended December 31, 2020, 2019 and 2018, respectively) | (21,166) | (17,601) | (9,684) |
Other income, net | 554 | 2,608 | 4,691 |
Net income (loss) before income taxes | 135,707 | 92,775 | (209,409) |
Income tax provision | 3,463 | 2,942 | 0 |
Net income (loss) | 132,244 | 89,833 | (209,409) |
Net loss attributable to non-controlling interest | 70 | ||
Net income (loss) attributable to Coherus | $ 132,244 | $ 89,833 | $ (209,339) |
Net income (loss) per share attributable to Coherus: | |||
Basic | $ 1.85 | $ 1.29 | $ (3.22) |
Diluted | $ 1.62 | $ 1.23 | $ (3.22) |
Weighted-average number of shares used in computing net income (loss) per share attributable to Coherus: | |||
Basic | 71,411,705 | 69,679,916 | 65,034,827 |
Diluted | 83,491,898 | 73,185,943 | 65,034,827 |
Consolidated Statements of Op_2
Consolidated Statements of Operations (Parenthetical) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Consolidated Statements of Operations | |||
Interest expense from transactions with related party | $ 2,498 | $ 2,457 | $ 2,421 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Income (Loss) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Consolidated Statements of Comprehensive Income (Loss) | |||
Net income (loss) | $ 132,244 | $ 89,833 | $ (209,409) |
Other comprehensive income (loss): | |||
Foreign currency translation adjustments, net of tax | 288 | (276) | 468 |
Comprehensive income (loss) | 132,532 | 89,557 | (208,941) |
Comprehensive loss attributable to non-controlling interest | 70 | ||
Comprehensive income (loss) attributable to Coherus | $ 132,532 | $ 89,557 | $ (208,871) |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity (Deficit) - USD ($) | Common Stock2019 Bonus Payout | Common Stock2018 Bonus Payout | Common StockCommon stock offering, net | Common Stock | Additional Paid-In Capital2019 Bonus Payout | Additional Paid-In Capital2018 Bonus Payout | Additional Paid-In CapitalCommon stock offering, net | Additional Paid-In Capital | Accumulated Other Comprehensive LossCumulative translation adjustment | Accumulated Other Comprehensive Loss | Accumulated Deficit | Total Coherus Stockholder Equity (Deficit)2019 Bonus Payout | Total Coherus Stockholder Equity (Deficit)2018 Bonus Payout | Total Coherus Stockholder Equity (Deficit)Common stock offering, net | Total Coherus Stockholder Equity (Deficit)Cumulative translation adjustment | Total Coherus Stockholder Equity (Deficit) | Noncontrolling Interest | 2019 Bonus Payout | 2018 Bonus Payout | Common stock offering, net | Cumulative translation adjustment | Total |
Beginning Balances at Dec. 31, 2017 | $ 6,000 | $ 808,060,000 | $ 468,000 | $ (750,000) | $ (775,492,000) | $ 468,000 | $ 31,824,000 | $ (1,289,000) | $ 468,000 | $ 30,535,000 | ||||||||||||
Beginning Balances, Shares at Dec. 31, 2017 | 59,840,467 | |||||||||||||||||||||
Issuance of common stock | $ 1,000 | $ 101,787,000 | $ 101,788,000 | $ 101,788,000 | ||||||||||||||||||
Issuance of common stock, Shares | 7,747,778 | |||||||||||||||||||||
Issuance of common stock upon exercise of stock options | 2,153,000 | 2,153,000 | 2,153,000 | |||||||||||||||||||
Issuance of common stock upon exercise of stock options, Shares | 477,019 | |||||||||||||||||||||
Issuance of common stock upon vesting of restricted stock units (RSUs), Shares | 61,804 | |||||||||||||||||||||
Issuance of common stock under the employee stock purchase plan ("ESPP") | 1,591,000 | 1,591,000 | 1,591,000 | |||||||||||||||||||
Issuance of common stock under the employee stock purchase plan ("ESPP"), Shares | 175,613 | |||||||||||||||||||||
Stock-based compensation expense | 34,984,000 | 34,984,000 | 34,984,000 | |||||||||||||||||||
Cumulative translation adjustment | 468,000 | |||||||||||||||||||||
Distributions to non-controlling interest | (2,060,000) | (2,060,000) | (70,000) | (2,130,000) | ||||||||||||||||||
Purchase of the remaining non-controlling interest | $ 1,359,000 | 1,359,000 | ||||||||||||||||||||
Net income (loss) attributable to Coherus | (209,339,000) | (209,339,000) | (209,339,000) | |||||||||||||||||||
Ending Balances at Dec. 31, 2018 | $ 7,000 | 946,515,000 | (276,000) | (282,000) | (984,831,000) | (276,000) | (38,591,000) | (276,000) | (38,591,000) | |||||||||||||
Ending Balances, shares at Dec. 31, 2018 | 68,302,681 | |||||||||||||||||||||
Issuance of common stock | $ 8,228,000 | $ 8,228,000 | $ 8,228,000 | |||||||||||||||||||
Issuance of common stock, Shares | 761,130 | |||||||||||||||||||||
Issuance of common stock upon exercise of stock options | 5,934,000 | 5,934,000 | 5,934,000 | |||||||||||||||||||
Issuance of common stock upon exercise of stock options, Shares | 863,940 | |||||||||||||||||||||
Issuance of common stock upon vesting of restricted stock units (RSUs) | $ 2,165,000 | $ 2,165,000 | $ 2,165,000 | |||||||||||||||||||
Issuance of common stock upon vesting of restricted stock units (RSUs), Shares | 175,054 | 39,765 | ||||||||||||||||||||
Issuance of common stock under the employee stock purchase plan ("ESPP") | $ 289,977 | 3,518,000 | 3,518,000 | 3,518,000 | ||||||||||||||||||
Taxes paid related to net share settlement of bonus payout in RSUs | (815,000) | (815,000) | (815,000) | |||||||||||||||||||
Taxes paid related to net share settlement of bonus payout in RSUs, Shares | (65,886) | |||||||||||||||||||||
Stock-based compensation expense | 35,218,000 | 35,218,000 | 35,218,000 | |||||||||||||||||||
Cumulative translation adjustment | (276,000) | |||||||||||||||||||||
Net income (loss) attributable to Coherus | 89,833,000 | 89,833,000 | 89,833,000 | |||||||||||||||||||
Ending Balances at Dec. 31, 2019 | $ 7,000 | 1,000,763,000 | $ 288,000 | (558,000) | (894,998,000) | $ 288,000 | 105,214,000 | $ 288,000 | $ 105,214,000 | |||||||||||||
Ending Balances, shares at Dec. 31, 2019 | 70,366,661 | 70,366,661 | ||||||||||||||||||||
Issuance of common stock | $ 2,378,000 | $ 2,378,000 | $ 2,378,000 | |||||||||||||||||||
Issuance of common stock, Shares | 134,099 | |||||||||||||||||||||
Issuance of common stock upon exercise of stock options | 17,061,000 | 17,061,000 | $ 17,061,000 | |||||||||||||||||||
Issuance of common stock upon exercise of stock options, Shares | 1,704,764 | 1,704,764 | ||||||||||||||||||||
Issuance of common stock upon vesting of restricted stock units (RSUs), Shares | 89,668 | |||||||||||||||||||||
Issuance of common stock under the employee stock purchase plan ("ESPP") | 3,801,000 | 3,801,000 | $ 3,801,000 | |||||||||||||||||||
Issuance of common stock under the employee stock purchase plan ("ESPP"), Shares | 267,772 | |||||||||||||||||||||
Taxes paid related to net share settlement of bonus payout in RSUs | (880,000) | (880,000) | (880,000) | |||||||||||||||||||
Taxes paid related to net share settlement of bonus payout in RSUs, Shares | (49,616) | |||||||||||||||||||||
Purchase of capped call options related to convertible notes due 2026 | (18,170,000) | (18,170,000) | (18,170,000) | |||||||||||||||||||
Stock-based compensation expense | 39,038,000 | 39,038,000 | 39,038,000 | |||||||||||||||||||
Cumulative translation adjustment | 288,000 | |||||||||||||||||||||
Net income (loss) attributable to Coherus | 132,244,000 | 132,244,000 | 132,244,000 | |||||||||||||||||||
Ending Balances at Dec. 31, 2020 | $ 7,000 | $ 1,043,991,000 | $ (270,000) | $ (762,754,000) | $ 280,974,000 | $ 280,974,000 | ||||||||||||||||
Ending Balances, shares at Dec. 31, 2020 | 72,513,348 | 72,513,348 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Operating activities | |||
Net income (loss) | $ 132,244 | $ 89,833 | $ (209,409) |
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities: | |||
Depreciation and amortization | 2,888 | 3,259 | 3,235 |
Remeasurement of fair-value contingent consideration | 42 | (3,230) | |
Stock-based compensation expense | 38,160 | 33,591 | 34,797 |
Non-cash accretion of discount on marketable securities | (155) | (165) | (301) |
Non-cash interest expense from amortization of debt discount | 3,481 | 2,339 | 1,484 |
Impairment of property and equipment | 110 | 3,861 | |
Excess and obsolete inventory | 0 | 410 | 0 |
Other non-cash adjustments | 426 | ||
Non-cash operating lease expense | 2,081 | 1,789 | |
Upfront and milestone based license fee payments | 7,500 | 11,075 | |
Changes in operating assets and liabilities: | |||
Trade receivables, net | (15,218) | (141,992) | |
Inventory | (36,188) | (48,184) | (5,484) |
Prepaid manufacturing | (10,851) | (672) | 7,063 |
Other prepaid and current assets | (235) | (2,126) | 1,146 |
Other assets, non-current | (1,785) | (348) | (1) |
Accounts payable | (9,820) | 9,893 | (301) |
Accounts payable - related parties | (233) | ||
Accrued rebates, fees and reserve | 30,409 | 51,120 | |
Accrued compensation | 6,212 | 10,035 | 8,466 |
Accrued and other liabilities | 5,486 | 10,386 | 69 |
Lease liabilities | 1,439 | 2,010 | |
Other liabilities, non-current | 949 | (30) | (428) |
Net cash provided by (used in) operating activities | 154,145 | 28,355 | (159,266) |
Investing activities | |||
Purchases of property and equipment | (7,231) | (1,822) | (789) |
Proceeds from disposal of property and equipment | 175 | ||
Purchases of investments in marketable securities | (273,845) | (20,235) | (42,869) |
Proceeds from maturities of investments in marketable securities | 274,000 | 20,400 | 43,170 |
Upfront and milestone based license fee payments | (7,500) | (11,075) | |
Purchase of non-controlling interest related to InteKrin Russia | (300) | ||
Purchase of non-controlling interest related to InteKrin Russia - related party | (400) | ||
Net cash used in investing activities | (14,401) | (12,732) | (1,188) |
Financing activities | |||
Proceeds from common stock offering, net of underwriters discounts, commissions and offering costs | 8,153 | 101,748 | |
Proceeds from issuance of Convertible Notes due 2026, net of issuance costs | 222,156 | ||
Purchase of capped call options related to Convertible Notes due 2026 | (18,170) | ||
Proceeds from term loan, net of issuance costs | 72,955 | ||
Proceeds from issuance of common stock upon exercise of stock options | 17,428 | 5,558 | 2,082 |
Proceeds from purchase under the employee stock purchase plan | 3,801 | 3,519 | 1,591 |
Taxes paid related to net share settlement of bonus payout in RSUs | (880) | (815) | |
Principal payments for finance lease obligations | (389) | ||
Net cash provided by financing activities | 223,946 | 89,370 | 105,421 |
Effect of exchange rate changes in cash, cash equivalents and restricted cash | (276) | 468 | |
Net increase (decrease) in cash, cash equivalents and restricted cash | 363,690 | 104,717 | (54,565) |
Cash, cash equivalents and restricted cash at beginning of period | 177,908 | 73,191 | 127,756 |
Cash, cash equivalents and restricted cash at end of period | 541,598 | 177,908 | 73,191 |
Supplemental disclosure of cash flow information | |||
Cash paid for interest | 16,959 | 15,263 | 8,200 |
Cash paid for income taxes | 3,953 | 1,732 | |
Right-of-use assets obtained in exchange for lease obligations related to operating leases | 1,388 | 5,267 | |
Right-of-use assets obtained in exchange for lease obligations related to finance leases | 1,817 | ||
Supplemental disclosures of non-cash investing and financing activities | |||
Purchase of property and equipment in accounts payable and accrued liabilities | 109 | 999 | 272 |
Non-cash non-controlling interest reflected in additional paid in capital | 1,359 | ||
Non-cash employee bonuses settled in common stock | $ 1,498 | $ 1,350 | |
Common stock offering costs in accounts payable and accrued liabilities | $ 75 |
Organization and Operations
Organization and Operations | 12 Months Ended |
Dec. 31, 2020 | |
Organization and Operations | |
Organization and Operations | 1. Description of the Business Coherus BioSciences, Inc. (the “Company” or “Coherus”) is a commercial-stage biotherapeutics company, focused on the biosimilar and immuno-oncology market primarily in the United States. The Company’s headquarters and laboratories are located in Redwood City, California and in Camarillo, California, respectively. The Company’s product pipeline comprises of four drugs, CHS-1420 (an adalimumab (Humira) biosimilar), a ranibizumab (Lucentis) biosimilar in-licensed for U.S. and Canadian commercial rights from Bioeq AG, a bevacizumab (Avastin) biosimilar in-licensed for U.S. commercial rights from Innovent Biologics (Suzhou) Co., Ltd. and toripalimab, an anti-PD-1 antibody being developed in collaboration with Shanghai Junshi Biosciences Co., Ltd. The Company commercializes UDENYCA® (pegfilgrastim-cbqv), a biosimilar to Neulasta, a long-acting granulocyte-colony stimulating factor, in the United States. |
Basis of Presentation and Summa
Basis of Presentation and Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2020 | |
Basis of Presentation and Summary of Significant Accounting Policies | |
Basis of Presentation and Summary of Significant Accounting Policies | 2. Basis of Consolidation The accompanying consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”). The accompanying consolidated financial statements include the accounts of Coherus and its wholly owned subsidiaries as of December 31, 2020: Coherus Intermediate Corp, InteKrin Therapeutics Inc. (“InteKrin”) and InteKrin’s wholly-owned subsidiary, InteKrin Russia. Unless otherwise specified, references to the Company are references to Coherus and its consolidated subsidiaries. All intercompany transactions and balances have been eliminated upon consolidation. Liquidity As of December 31, 2020, the Company had an accumulated deficit of $762.8 million and cash and cash equivalents of $541.2 million. The Company had $132.2 million in net income for the year ended December 31, 2020. The Company believes that its current available cash, cash equivalents and cash collected from UDENYCA® sales will be sufficient to fund its planned expenditures and meet the Company’s obligations for at least 12 months following its financial statement issuance date . 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 reported in the financial statements. Management uses significant judgment when making estimates including, but not limited to: those related to revenue recognition, including determining the nature and timing of satisfaction of performance obligations, and determining the standalone selling price of performance obligations, and variable consideration such as rebates, chargebacks, sales returns and sale allowances, as well as milestones included in collaboration and license arrangements; related to its stock-based compensation, valuation of deferred tax assets, impairment of goodwill and long-lived assets, the valuation of acquired intangible assets, valuation and reserves for inventory, clinical trial accruals, contingent consideration, convertible notes valuation, as well as certain accrued liabilities. Management bases its estimates on historical experience and on other various assumptions that are believed to be reasonable under the circumstances. These estimates form the basis for making judgments about the carrying values of assets and liabilities when these values are not readily apparent from other sources. Accounting estimates and judgements are inherently uncertain and the actual results could differ from these estimates. During the second quarter of 2020, the Company identified that certain of its commercial payer invoices were erroneously overstated. The Company received a refund of $7.5 million from these payers related to fiscal year 2019 which resulted in an increase in net product revenue of $7.5 million for the year ended December 31, 2020. The refund adjustment resulted in an increase in basic and diluted net income per share of $0.11 and $0.09, respectively, during the year ended December 31, 2020. Accrued commercial payer rebates of $27.9 million and $14.0 million were recorded in accrued rebates, fees and reserve as of December 31, 2020 and December 31, 2019, respectively, in the consolidated balance sheet. Foreign Currency The functional currency of InteKrin Russia, which the Company acquired in February 2014, is the Russian Ruble. Accordingly, the financial statements of this subsidiary are translated into U.S. dollars using appropriate exchange rates. Unrealized gains or losses on translation are recognized in accumulated other comprehensive loss in the consolidated balance sheet. For the years ended December 31, 2020, 2019 and 2018, the foreign exchange gains and losses recorded in other income, net in the consolidated statements of operations were a net loss of $333,000, net gain of $239,000 and a net loss of $571,000, respectively. Segment Reporting and Revenue by Geographic Region The Company operates and manages its business as one reportable and operating segment, which is the business of developing and commercializing biosimilar products and, as part of the InteKrin acquisition, small molecules. The Company’s chief executive officer, who is the chief operating decision maker, reviews financial information on an aggregate basis for purposes of allocating resources and evaluating financial performance. All revenue is generated in the United States of America and all Long-lived assets are primarily maintained in the United States of America. Cash, Cash Equivalents and Restricted Cash Cash, cash equivalents and restricted cash are comprised of cash and highly liquid investments with remaining maturities of 90 days or less at the date of purchase. The Company limits cash investments to financial institutions with high credit standings; therefore, management believes that there is no significant exposure to any credit risk in the Company’s cash, cash equivalents and restricted cash. The following table provides a reconciliation of cash, cash equivalents and restricted cash within the consolidated balance sheets and which, in aggregate, represent the amount reported in the consolidated statements of cash flows (in thousands): Year Ended December 31, 2020 2019 2018 Cash and cash equivalents $ 541,158 $ 177,668 $ 72,356 Restricted cash — — 50 Restricted cash - non-current 440 240 785 Total cash, cash equivalents and restricted cash $ 541,598 $ 177,908 $ 73,191 Restricted cash – non-current consists of deposits for a letter of credit that the Company has provided to secure its obligations under certain facility and other leases. The Company classifies the up-front and milestone payments related to licensing arrangements as cash flows from investing activities in its consolidated statements of cash flows. Investments in Marketable Securities 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 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 are reported as a component of accumulated comprehensive income (loss), with the exception of unrealized losses believed to be related to credit losses, which, if any, are recognized through 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 and declines in value judged to be other than temporary, if any, on available-for-sale securities are included in other income, net, based on the specific identification method. For the years ended December 31, 2020, 2019 and 2018, interest income from marketable securities was $0.6 million, $1.6 million and $1.4 million, respectively. Trade Receivables Trade receivables are recorded net of allowances for chargebacks, chargeback prepayments, cash discounts for prompt payment and credit losses. The Company estimates an allowance for expected credit losses by considering factors such as historical experience, credit quality, the age of the accounts receivable balances, and current economic conditions that may affect a customer’s ability to pay. The corresponding expense for the credit loss allowance is reflected in selling, general and administrative expenses. The credit loss allowance was immaterial as of December 31, 2020. Concentration of Credit Risk The Company’s financial instruments that are exposed to concentration of credit risk consist primarily of cash, cash equivalents and restricted cash. The Company maintains its cash in bank accounts, which at times exceed federally insured limits. The Company attempts to minimize the risks related to cash, cash equivalents and restricted cash by investing in money markets with a broad and diverse range of financial instruments. The investment portfolio is maintained in accordance with the Company’s investment policy, which defines allowable investments, specifies credit quality standards and limits the credit exposure of any single issuer. The Company also maintains restricted cash in money market funds that invest primarily in U.S. Treasury securities. The Company has not recognized any losses from credit risks on such accounts during any of the periods presented. The Company believes it is not exposed to significant credit risk on its cash and money market funds. The Company is subject to credit risk from trade receivables related to the product sales in the United States. To date, the Company has not experienced significant losses with respect to the collection of trade receivables. The Company believes that its allowance for doubtful accounts was adequate at December 31, 2020. The Company entered into a strategic commercial supply agreement with KBI Biopharma (“KBI”) for the supply of UDENYCA®. The Company currently has not engaged back-up suppliers or vendors for this single-sourced service. If KBI is not able to manufacture the supply needed in the quantities and timeframe required, the Company may not be able to supply the product in a timely manner. Fair Value of Financial Instruments Fair value accounting is applied to all financial assets and liabilities and non-financial assets and liabilities that are recognized or disclosed at fair value in the financial statements on a recurring basis. Inventory Prior to the regulatory approval of the product candidates, the Company incurred expenses for the manufacture of drug product that could potentially be available to support the commercial launch of its products. The Company began to capitalize inventory costs associated with UDENYCA® after receiving regulatory approval for UDENYCA® in November 2018 when it was determined that the inventory had a probable future economic benefit. Inventory is stated at the lower of cost or estimated net realizable value with cost determined under the first-in first-out method. Inventory costs include third-party contract manufacturing, third-party packaging services, freight, labor costs for personnel involved in the manufacturing process, and indirect overhead costs. The Company primarily uses actual costs to determine the cost basis for inventory. The determination of whether inventory costs will be realizable requires management review of the expiration dates of UDENYCA® compared to its forecasted sales. If actual market conditions are less favorable than projected by management, write-downs of inventory may be required, which would be recorded as cost of goods sold in the consolidated statement of operations. Property and Equipment Property and equipment is stated at cost less accumulated depreciation and amortization. Maintenance and repairs are charged to expense as incurred, and costs of improvements are capitalized. Depreciation and amortization is recognized using the straight-line method over the following estimated useful lives: Computer equipment and software 3 years Furniture and fixtures 5 years Machinery and equipment 5 years Leasehold improvements Shorter of lease term or useful life Impairment of Long Lived Assets and Acquired Intangible Asset The Company reviews long-lived assets, including property and equipment, and indefinite-lived intangible assets for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets may not be fully recoverable. An impairment loss would be recognized when the estimated undiscounted future cash flows expected to result from the use of the asset and its eventual disposition is less than its carrying amount. Impairment, if any, is measured as the amount by which the carrying value of a long-lived asset exceeds its fair value. There were no impairments recorded during the year ended December 31, 2020. For the years ended December 31, 2019 and 2018, the Company recorded an impairment of property and equipment of $0.1 million and $3.9 million, respectively, in research and development within the statement of operations. The intangible assets of $2.6 Goodwill Goodwill represents the excess of the purchase price over the fair value of the net tangible and intangible assets acquired. The Company tests goodwill for impairment at least annually or more frequently if events or changes in circumstances indicate that this asset may be impaired. The goodwill test is based on our single operating segment and reporting unit structure. The Company compares the fair value of its reporting unit to its carrying value. If the carrying value of the net assets assigned to the reporting unit exceeds the fair value of the reporting unit, then the Company would need to determine the implied fair value of the reporting unit’s goodwill. If the carrying value of the reporting unit’s goodwill exceeds its implied fair value, then the Company would record an impairment loss equal to the difference. No goodwill impairment was identified through December 31, 2020. Accrued Research and Development Expense Clinical trial costs are a component of research and development expense. The Company accrues and expenses clinical trial activities performed by third parties based upon actual work completed in accordance with agreements established with clinical research and manufacturing organizations and clinical sites. The Company determines the actual costs through monitoring patient enrollment, discussions with internal personnel and external service providers regarding the progress or stage of completion of trials or services and the agreed-upon fee to be paid for such services. Net Product Revenue The Company accounts for sales of UDENYCA® under Topic 606 Revenue from Contracts with Customers Product Sales Discounts and Allowances Revenue from product sales is recorded at the net sales price (“transaction price”), which includes estimates of variable consideration for which reserves are established and that result from chargebacks, rebates, co-pay assistance, prompt-payment discounts, returns and other allowances that are offered within contracts between the Company and its Customers, Healthcare Providers, payers and GPOs relating to the sales of UDENYCA®. These reserves are based on the amounts earned or to be claimed on the related sales and are classified as reductions in trade receivables (if the amounts are payable to a Customer) or current liabilities (if the amounts are payable to a party other than a Customer). Where appropriate, these estimates take into consideration a range of possible outcomes that are probability-weighted for relevant factors such as historical experience, current contractual and statutory requirements, specifically known market events and trends, industry data and forecasted Customer buying and payment patterns. Overall, these reserves reflect the best estimates of the amount of consideration to which the Company is entitled based on the terms of its contracts. The amount of variable consideration that is included in the transaction price may be constrained, and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. The actual amount of consideration ultimately received may differ. If actual results in the future vary from the Company’s estimates, the estimates will be adjusted, which will affect the net product revenue in the period that such variances become known. Chargebacks: Discounts for Prompt Payment: Rebates: Co-payment Assistance: Product Returns: Other Allowances: Cost of Goods Sold Cost of goods sold consists primarily of third-party manufacturing, distribution, and overhead costs associated with UDENYCA®. A portion of the costs of producing UDENYCA® sold to date was expensed as research and development prior to the FDA approval of UDENYCA® and, therefore, it is not reflected in the cost of goods sold. On May 2, 2019, the Company and Amgen Inc. and Amgen USA Inc. (collectively “Amgen”) settled a trade secret action brought by Amgen. As a result, cost of goods sold reflects a mid-single digit royalty on net product revenue, which began on July 1, 2019. The royalty cost will continue for five years pursuant to the settlement. Cost of goods sold for the year ended December 31, 2019, included write-off of prepaid manufacturing costs of $1.3 million due to the cancellation of certain manufacturing reservations, and $0.4 million due to the write-off of excess and obsolete inventory. There were no material inventory write-offs recorded during the years ended December 31, 2020 and 2018. Research and Development Expense Research and development costs are charged to expense as incurred. Research and development expense includes, among other costs, salaries and other personnel-related costs, consultant fees, preclinical costs, cost to manufacture drug candidates, clinical trial costs and supplies, laboratory supply costs, upfront and milestone payments under the licensing agreements and facility-related costs. Costs incurred under agreements with third parties are charged to expense as incurred in accordance with the specific contractual performance terms of such agreements. Third-party costs include costs associated with manufacturing drug candidates, preclinical and clinical support activities. In certain cases, amounts received as reimbursement for research and development activities from the Company’s collaborators are recognized as a reduction in research and development expense when the Company engages in a research and development project, jointly with another party, with both parties incurring costs while actively participating in project activities and sharing costs and potential benefits of the arrangement. Costs incurred under arrangements where the Company provides research services approximate the amount of revenues recorded. Advance payments for goods or services to be received in the future to be utilized in research and development activities are deferred and capitalized. The capitalized amounts are expensed as the related goods are delivered or the services are rendered. The Company considers regulatory approval of product candidates to be uncertain, and product manufactured prior to regulatory approval may not be sold unless regulatory approval is obtained. The Company expenses manufacturing costs as incurred to research and development expense for product candidates prior to regulatory approval. If, and when, regulatory approval of a product is obtained, the Company will begin capitalizing manufacturing costs related to the approved product into inventory. Costs associated with the development, validation and scaling of manufacturing processes at new third party suppliers and regulatory registration of new third-party manufacturing facilities are recognized as research and development expenses. These costs generally comprise of all costs incurred in such activities prior to the process performance qualification (“PPQ”) production commencement stage at new manufacturing facilities. Costs incurred after the PPQ production commencement at new manufacturing facilities are capitalized as inventory as the regulatory approval at that point becomes probable and the net realizable value of the batches produced during this stage of the process is recoverable. License Agreements The Company has entered and may continue to enter into license agreements to access and utilize certain technology. To determine whether the licensing transactions should be accounted for as a business combination or as an asset acquisition, the Company makes certain judgments, which include assessing whether the acquired set of activities and assets would meet the definition of a business under the relevant accounting rules. If the acquired set of activities and assets does not meet the definition of a business, the transaction is recorded as an acquisition of assets and, therefore, any acquired IPR&D that does not have an alternative future use is charged to expense at the acquisition date. To date none of the Company’s license agreements have been considered to be the acquisition of a business. Selling, General and Administrative Expense Selling, general and administrative expenses are primarily comprised of compensation and benefits associated with sales and marketing, finance, human resources, legal, information technology and other administrative personnel, outside marketing, advertising and legal expenses and other general and administrative costs. The Company expenses the cost of advertising, including promotional expenses, as incurred. Advertising expenses were $3.8 million, $4.5 million and $2.8 million for the years ended December 31, 2020, 2019 and 2018, respectively. Stock-Based Compensation The Company measures the cost of equity-based service awards based on the grant-date fair value of the award. The compensation cost is recognized as expense on a straight-line basis over the vesting period for options and restricted stock units (“RSU”). The Company accounts for forfeitures as they occur. On January 1, 2019, the Company adopted the ASU No. 2018-07, Improvements to Nonemployee Share-Based Payment Accounting The Company utilizes the Black-Scholes option-pricing model for estimating fair value of its stock options and ESPP granted. Option valuation models, including the Black-Scholes option-pricing model, require the input of highly subjective assumptions, and changes in the assumptions used can materially affect the grant-date fair value of an award. These assumptions include the risk-free rate of interest, expected dividend yield, expected volatility and the expected life of the award. For RSUs, the Company bases the fair value of awards on the closing market value of the common stock at the date of grant. Income Taxes The Company uses the liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are determined based on the differences between the financial reporting and the tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. The Company must then assess the likelihood that the resulting deferred tax assets will be realized. A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized. Due to the Company’s lack of earnings history, the net deferred tax assets have been fully offset by a valuation allowance. The Company recognizes uncertain income tax positions at the largest amount that is more likely than not to be sustained upon audit by the relevant taxing authority. An uncertain income tax position will not be recognized if it has less than a 50% likelihood of being sustained. The Company does not expect its unrecognized tax benefits to change significantly over the next twelve months. The Company’s policy is to recognize interest and/or penalties related to income tax matters in income tax expense. The Company had accrued no amounts for interest and penalties related to income tax matters in the Company’s consolidated balance sheet at December 31, 2020 and 2019. Operating and Finance Leases The Company adopted ASU 2016-02, Leases guidance, ASC Topic 840: Leases The Company determines if an arrangement is a lease at inception. Operating leases are included in operating lease right-of-use assets, other current liabilities, and lease liabilities, non-current in the consolidated balance sheets. The Lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise any such options. The Company recognizes operating lease expense for these leases on a straight-line basis over the term of the lease. In 2019, the Company entered into a vehicle lease agreement, pursuant to which it currently leases 42 vehicles. Delivery of the vehicles commenced during the first quarter of 2020. The term of each leased vehicle commences upon the delivery of the vehicle and is for a period of 36 months. The vehicles leased under this arrangement were classified as finance leases. Assets acquired under finance leases are included in property and equipment, net, other current liabilities, and lease liabilities, non-current in the consolidated balance sheets and are depreciated to operating expenses on a straight-line basis over their estimated useful lives. With the exception of initial adoption of the new lease standard, where the Company’s incremental borrowing rate used was the rate on the adoption date (January 1, 2019), the operating and finance lease ROU assets and the lease liabilities are recognized based on the present value of lease payments over the lease term at the lease commencement date. The Company uses its incremental borrowing rate based on the information available at the commencement date in determining the lease liabilities, as the Company's leases generally do not provide an implicit rate. Net Income (Loss) per Share Attributable to Coherus Basic net income (loss) per share attributable to Coherus is calculated by dividing the net income (loss) attributable to Coherus by the weighted-average number of shares of common stock outstanding for the period, without consideration for potential dilutive common shares. Diluted net income (loss) per share is computed by dividing the net income (loss) by the weighted average number of common shares outstanding for the period plus any diluted potential common shares outstanding for the period determined using the treasury stock method for options, RSUs and ESPP and using the if-converted method for the convertible notes (see Note 14). Comprehensive Income (Loss) Comprehensive income (loss) is composed of two components: net income (loss) and other comprehensive income (loss). Other comprehensive income (loss) refers to gains and losses that under U.S. GAAP are recorded as an element of stockholders’ equity (deficit), but are excluded from net income (loss). The Company’s other comprehensive income (loss) included foreign currency translation adjustments for the years ended December 31, 2020, 2019 and 2018. Recent Accounting Pronouncements The following are the recent accounting pronouncements adopted by the Company in 2020: Effective January 1, 2020, the Company adopted ASU No. 2016-13, Financial Instruments — Credit Losses, (Topic 326): Measurement of Credit Losses on Financial Instruments ASU 2016-13) ASU 2016-13 also eliminates the concept of “other-than-temporary” impairment when evaluating available-for-sale debt securities and instead focuses on determining whether any impairment is a result of a credit loss or other factors. An entity will recognize an allowance for credit losses on available-for-sale debt securities, rather than an other-than-temporary impairment that reduces the cost basis of the investment. In January 2017, the FASB issued ASU No. 2017-04, Intangibles-Goodwill and Other: Simplifying the Test for Goodwill Impairment In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurements The following are the recent accounting pronouncements that the Company has not yet adopted: In August 2020, the FASB issued , Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging Contracts in Entity’s Own Equity (Subtopic 815-40) which reduces the number of accounting models for convertible debt instruments and convertible preferred stock as well as amends the derivatives scope exception for contracts in an entity’s own equity. effective for the Company on January 1, 2022, with early adoption permitted. The Company is currently evaluating the potential impact that this standard may have on its consolidated financial statements and related disclosures. The Company has reviewed other recent accounting pronouncements and concluded they are either not applicable to the business or that no material effect is expected on the consolidated financial statements as a result of future adoption. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2020 | |
Fair Value Measurements | |
Fair Value Measurements | 3. Financial assets and liabilities are recorded at fair value. The carrying amounts of certain of the Company’s financial instruments, including cash and cash equivalents, restricted cash, investments in marketable securities, accounts receivable, accounts payable and other current liabilities approximate their fair value due to their short maturities. Fair value is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The accounting guidance describes a fair value hierarchy based on three levels of inputs that may be used to measure fair value, of which the first two are considered observable and the last is considered unobservable. These levels of inputs are the following: Level 1 — Quoted prices in active markets for identical assets or liabilities. Level 2 — Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. The Company’s financial instruments consist of Level 1 assets and Level 3 liabilities. 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 unrealized gains and losses in the Company’s investments in these money market funds In certain cases where there is limited activity or less transparency around inputs to valuation, securities are classified as Level 3. Level 3 liabilities consist of the contingent consideration. There were no transfers Level 1 Level 2 Level 3 during Financial assets and liabilities subject to fair value measurements on a recurring basis and the level of inputs used in such measurements are as follows (in thousands): Fair Value Measurements December 31, 2020 Total Level 1 Level 2 Level 3 Financial Assets: Money market funds $ 538,673 $ 538,673 $ — $ — Restricted cash (money market funds) 440 440 — — Total financial assets $ 539,113 $ 539,113 $ — $ — Financial Liabilities: Contingent consideration $ 102 $ — $ — $ 102 Fair Value Measurements December 31, 2019 Total Level 1 Level 2 Level 3 Financial Assets: Money market funds $ 155,523 $ 155,523 $ — $ — Restricted cash (money market funds) 240 240 — — Total financial assets $ 155,763 $ 155,763 $ — $ — Financial Liabilities: Contingent consideration $ 102 $ — $ — $ 102 Contingent Consideration As part of the InteKrin acquisition in February 2014, the Company recognized contingent consideration associated with potential payments to be made to the former InteKrin stockholders upon (i) the first dosing of a human subject in the first Phase 2 Clinical Trial for CHS-131 (“Earn-Out Payment”), which was achieved and settled by the Company in March 2015, and (ii) per a compound transaction agreement as defined in the purchase agreement (the “Compound Transaction Payment”). The size of the Compound Transaction Payment consideration is tiered based on the size of a license or similar agreement with a third party and the timing of such agreement. The fair value measurement of the Compound Transaction Payment uses a probability-weighted discounted cash flow approach based on significant inputs not observable in the market and thus represents a Level 3 measurement within the fair value hierarchy. The Compound Transaction analysis as of December 31, 2020 applied a 20% risk-adjusted discount rate to measure present value and also captured an additional 8.0% credit spread for counterparty credit risk given the cash payment. The expected cash flow is based on estimates provided by the Company’s management including the timing and probability of occurrence. The value of the consideration is tiered based on the value of a license or similar agreement with a third party and the timing of such agreement. Generally, increases or decreases in the probability of occurrence would result in a directionally similar impact in the fair value measurement of the Compound Transaction Payment and it is estimated that a 1% increase (decrease) in the probability of occurrence would result in an immaterial fair value fluctuation. For the years ended December 31, 2020, 2019 and 2018, the Company recognized a loss of $0, a loss of $42,000 and a gain of $3.2 million in other income, net in the consolidated statement of operations, respectively, as a result of the change in the fair value of the Compound Transaction Payment. The following table sets forth a summary of changes in the estimated fair value of the contingent consideration (in thousands): Balance as of December 31, 2017 $ 3,290 Change in fair value of the contingent consideration liability (3,230) Balance as of December 31, 2018 60 Change in fair value of the contingent consideration liability 42 Balance as of December 31, 2019 102 Change in fair value of the contingent consideration liability — Balance as of December 31, 2020 $ 102 The decrease of $3.2 million in the fair value of the Compound Transaction Payment during the year ended December 31, 2018 was primarily a result of a decrease in the probability of occurrence from 33% to 10% and an extension in the timing of occurrence to a later date. 1.5% Convertible Notes due 2026 influenced by interest rates, the Company’s stock price and stock price volatility and is determined by prices observed in market trading. The market for trading of the Convertible Notes due 2026 is not considered to be an active market and therefore the estimate of fair value is based on Level 2 inputs. The estimated fair value of the Convertible Notes due 2026 was approximately $ (par value $230.0 million) as of December 31, 2020. 8.2% Convertible Notes due 2022 The estimated fair value of the 8.2% Convertible Senior Notes Due 2022, which the Company issued on February 29, 2016 (see Note 8) is based on an income approach. The estimated fair value was approximately $113.7 million (par value $100.0 million) as of December 31, 2020 and represents a Level 3 valuation. When determining the estimated fair value of the Company’s long-term debt, the Company uses a single factor binomial lattice model which incorporates the terms and conditions of the convertible notes and market based risk measurement that are indirectly observable, such as credit risk. The lattice model produces an estimated fair value based on changes in the price of the underlying common shares price over successive periods of time. An estimated yield based on market data is used to discount straight debt cash flows. Term Loan The principal amount outstanding under the Company’s Term Loan (see Note 8) of $75 million as of December 31, 2020 is subject to variable interest rate, which is based on a fixed percentage plus three month LIBOR (“LIBOR”), and as such, the Company believes the carrying amount of these obligations approximates fair value. |
Inventory
Inventory | 12 Months Ended |
Dec. 31, 2020 | |
Inventory | |
Inventory | 4. The Company began capitalizing inventory in November 2018 once the FDA approved UDENYCA®. Inventory consisted of the following (in thousands): December 31, December 31, 2020 2019 Raw Materials $ 5,205 $ 5,089 Work in process 43,952 43,446 Finished goods 43,032 6,536 Total $ 92,189 $ 55,071 Balance sheet classification (in thousands): December 31, December 31, 2020 2019 Inventory $ 44,233 $ 9,807 Inventory, non-current 47,956 45,264 Total $ 92,189 $ 55,071 Inventory expected to be sold in periods more than twelve months from the balance sheet date is classified as inventory, non-current on the consolidated balance sheets. As of December 31, 2020 and 2019, the non-current portion of inventory consisted of raw materials and a portion of work in process. Prepaid manufacturing of $19.4 million as of December 31, 2020 includes prepayments of $8.9 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 $10.5 million to various CMOs for other research and development pipeline programs. Prepaid manufacturing of $8.6 million as of December 31, 2019 includes prepayments of $7.2 million to a CMO for manufacturing services for UDENYCA®; and prepayments of $1.4 million to various CMOs for other research and development pipeline programs. Other Assets, non-current of $2.1 million on the consolidated balance sheet as of December 31, 2020 primarily includes prepayments of $1.3 million made to a CMO for manufacturing services for UDENYCA®, which the Company expects to be converted into inventory after twelve months. The other assets, non current balance was immaterial as of December 31, 2019. |
Balance Sheet Components
Balance Sheet Components | 12 Months Ended |
Dec. 31, 2020 | |
Balance Sheet Components | |
Balance Sheet Components | 5. Property and Equipment, Net Property and equipment, net are as follows (in thousands): December 31, December 31, 2020 2019 Machinery and equipment $ 13,301 $ 12,611 Computer equipment and software 3,996 2,923 Furniture and fixtures 1,268 714 Leasehold improvements 5,830 4,388 Finance lease right of use assets 1,451 — Construction in progress 312 1,500 Total property and equipment 26,158 22,136 Accumulated depreciation and amortization (16,050) (16,296) Property and equipment, net $ 10,108 $ 5,840 Depreciation and amortization expense was $2.9 million, $3.3 million and $3.2 million for the years ended December 31, 2020, 2019 and 2018, respectively. During the year ended December 31, 2018, the Company identified an impairment indicator in machinery and equipment and upon further analysis recorded an impairment loss of $3.9 million within research and development expense in the consolidated statement of operations, given the undiscounted future cash flows were less than the carrying amount of the related machinery and equipment. There were no material impairments of property and equipment for the years ended December 31, 2020 and 2019. Accrued Liabilities Accrued liabilities are as follows (in thousands): December 31, December 31, 2020 2019 Accrued clinical and manufacturing $ 11,365 $ 7,106 Accrued other 11,453 10,152 Accrued liabilities $ 22,818 $ 17,258 6. |
Revenue
Revenue | 12 Months Ended |
Dec. 31, 2020 | |
Revenue | |
Revenue | 6. Revenue The Company initiated U.S. sales of UDENYCA® on January 3, 2019. The Company recorded net product revenue of $475.8 million and $356.1 million during the years ended December 31, 2020 and 2019, respectively. There was no product revenue during the year ended December 31, 2018. Revenue by significant Customer was distributed as follows: Year Ended Year Ended December 31, 2020 December 31, 2019 Percent of Total Percent of Total McKesson 38 % 42 % AmeriSource-Bergen Corp 37 % 33 % Cardinal 23 % 23 % Others 2 % 2 % Total revenue 100 % 100 % 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 (in thousands): Year Ended December 31, 2020 Chargebacks Other Fees, and Discounts Co-pay for Prompt Assistance Payment Rebates and Returns Total Balance at December 31, 2019 $ 35,159 $ 27,494 $ 24,494 $ 87,147 Provision related to sales made in: Current period 462,328 115,864 114,372 692,564 Prior period (1,336) (3,438) (6,288) (11,062) Payments and customer credits issued (455,571) (85,862) (103,818) (645,251) Balance at December 31, 2020 $ 40,580 $ 54,058 $ 28,760 $ 123,398 Year Ended December 31, 2019 Chargebacks Other Fees, and Discounts Co-pay for Prompt Assistance Payment Rebates and Returns Total Balance at December 31, 2018 $ — $ — $ — $ — Activity related to 2019 sales 226,901 46,810 70,775 344,486 Payments and customer credits issued (191,742) (19,316) (46,281) (257,339) Balance at December 31, 2019 $ 35,159 $ 27,494 $ 24,494 $ 87,147 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 consolidated balance sheets. |
Licensing Arrangements
Licensing Arrangements | 12 Months Ended |
Dec. 31, 2020 | |
Licensing Arrangements | |
Licensing Arrangements | 7. Bioeq AG On November 4, 2019, the Company entered into a license agreement with Bioeq IP AG (now Bioeq AG, or “Bioeq”) for the commercialization of a biosimilar version of ranibizumab (Lucentis) in certain dosage forms in both a vial and pre-filled syringe presentation (the “Licensed Products”). Under this agreement, Bioeq granted to the Company an exclusive, royalty-bearing license to commercialize the Licensed Products in the field of ophthalmology (and any other approved labelled indication) in the United States. Bioeq will supply to the Company the 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 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 Licensed Products in the U.S. in accordance with a development and manufacturing plan, and the Company must use commercially reasonable efforts to commercialize the 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 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 for the year ended December 31, 2019. The Company is obligated to pay Bioeq an aggregate of up to €25 million in additional milestone payments in connection with the achievement of certain development and regulatory milestones with respect to the Licensed Products in the United States. The Company will share a percentage of gross profits on sales of 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 due. As of December 31, 2020 and 2019, the Company did not have any outstanding obligations for milestones and royalties to Bioeq. Innovent Biologics (Suzhou) Co., Ltd. Innovent will supply the Innovent Licensed Products to the Company in accordance with a manufacturing and supply agreement to be executed by the parties. Under the License Agreement, the Company acquired the right to require Innovent to perform technology transfer for the manufacturing of the Innovent Licensed Products in the Territory and, upon completion of such technology transfer, the Company will have the exclusive right to manufacture the Innovent Licensed Products in the Territory. Under the 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 is 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 will share a percentage of net sales of Innovent Licensed Products with Innovent in the mid-teens to low twenty percent range. If the Company exercises its option to acquire Innovent’s biosimilar version of rituximab (Rituxan®), it would be required to pay a fee of $5.0 million. Subject to the terms of the License Agreement, if the Company requests Innovent to perform technology transfer for the manufacturing of the Innovent Licensed Products, it would be required to pay up to $10.0 million for fees related thereto. The Company accounted for the licensing transaction as an asset acquisition under the relevant accounting rules. The Company recorded research and development expense of $7.5 million during the year ended December 31, 2020 related to an upfront payment and a milestone payment for the bevacizumab Licensed Product. As of December 31, 2020 the Company did not have any outstanding milestone or royalty payment obligations to Innovent. The additional milestone payments, option fee for licensing of rituximab (Rituxan®), manufacturing technology transfer fee and royalties are contingent upon future events and, therefore, will be recorded when it is probable that a milestone will be achieved, option fee or manufacturing technology transfer fee will be incurred or when royalties are due. |
Debt Obligations
Debt Obligations | 12 Months Ended |
Dec. 31, 2020 | |
Debt Obligations | |
Debt Obligations | 8. 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 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 will have customary provision relating to the occurrence of “events of default” (as defined in the Indenture for the 2026 Convertible Notes). The occurrence of such events of default could result in the acceleration of all amounts due under the 2026 Convertible Notes. As of December 31, 2020, the Company was in full compliance with these covenants and there were no events of default under the 2026 Convertible Notes. The 2026 Convertible Notes are accounted for in accordance with ASC 470-20, Debt with Conversion and Other Options Contracts in Entity’s Own Equity requirements of the equity classification guidance. The Company determined that the 2026 Convertible Notes do contain embedded features indexed to its own stock, but do not meet the requirements for bifurcation, and therefore do not need to be separately accounted for as an equity component. Since the embedded conversion feature meets the equity scope exception from derivative accounting, and also since the embedded conversion option does not need to be separately accounted for as an equity component under ASC 470-20, the proceeds received from the issuance of the convertible debt were recorded as a liability on the consolidated balance sheet. Capped Call Transactions In connection with the pricing of the 2026 Convertible Notes, the Company also paid $18.2 million to enter into privately negotiated capped call transactions with one or more of 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 Company evaluated the capped call transactions under ASC 815-10 and determined that it should be accounted as a separate transaction from the 2026 Convertible Notes and that the capped calls should be classified as equity instruments. Therefore, the capped call premium paid in the amount of $ 18.2 million was recorded as a reduction to additional paid-in capital. 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 consolidated balance sheet. The debt issuance costs is being amortized and recognized as additional interest expense over the six-year contractual term of the notes using the effective interest rate method. The following table summarizes information about the components of the 2026 Convertible Notes (in thousands): December 31, 2020 Principal amount of the 2026 Convertible Notes $ 230,000 Unamortized debt discount and debt issuance costs (6,971) Total 2026 Convertible Notes $ 223,029 If the 2026 Convertible Notes were to be converted on December 31, 2020, the holders of the 2026 Convertible Notes would receive common shares with an aggregate value of $207.6 million based on the Company’s closing stock price of $17.38 as of December 31, 2020. The following table presents the components of interest expense related to 2026 Convertible Notes (in thousands): Year Ended December 31, 2020 Stated coupon interest $ 2,434 Accretion of debt discount and debt issuance costs 873 Total interest expense $ 3,307 The remaining unamortized debt discount and debt offering costs related to the Company’s 2026 Convertible Notes of approximately $7.0 million as of December 31, 2020, will be amortized using the effective interest rate over the remaining term of the 2026 Convertible Notes of 5.3 years. The annual effective interest rate is 2.11% for the 2026 Convertible Notes. Future payments on the 2026 Convertible Notes as of December 31, 2020 are as follows (in thousands): Year ending December 31, 2021 3,450 2022 3,450 2023 3,450 2024 3,450 2025 and beyond 235,175 Total minimum payments 248,975 Less amount representing interest (18,975) 2026 Convertible Notes, principal amount 230,000 Less debt discount and debt issuance costs on 2026 Convertible Notes (6,971) Net carrying amount of 2026 Convertible Notes $ 223,029 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”) and received total net proceeds of approximately $99.2 million, after deducting issuance costs of $0.8 million. The 2022 Convertible Notes constitute general, senior unsubordinated obligations of the Company and are guaranteed by certain subsidiaries of the Company. The 2022 Convertible Notes bear 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, which commenced on March 31, 2016, and mature on March 31, 2022, unless earlier converted, redeemed or repurchased. If the Company fails to satisfy certain registration or reporting requirements, then additional interest will accrue on the 2022 Convertible Notes at a rate of up to 0.50% per annum in the aggregate. The 2022 Convertible Notes also bear a premium of 9% of their principal amount, which is payable when the 2022 Convertible Notes mature or are repurchased or redeemed by the Company. The 2022 Convertible Notes were issued to Healthcare Royalty Partners III, L.P., for $75.0 million in aggregate principal amount, and to three related party investors, KKR Biosimilar L.P., MX II Associates LLC, and KMG Capital Partners, LLC, for $20.0 million, $4.0 million, and $1.0 million, respectively, in aggregate principal amount. The 2022 Convertible Notes are convertible at the option of the holder at any time prior to the close of business on the business day immediately preceding March 31, 2022 at the initial conversion rate of 44.7387 shares of common stock per $1,000 principal amount of 2022 Convertible Notes, which is equivalent to an initial conversion price of approximately $22.35 per share, and is subject to adjustment in certain events. Upon conversion of the 2022 Convertible Notes by a holder, the holder will receive shares of the Company’s common stock together, if applicable, with cash in lieu of any fractional share. The 2022 Convertible Notes are redeemable in whole, and not in part, at the Company’s option on or after March 31, 2020, if the last reported sale price per share of common stock exceeds 160% of the conversion price on 20 or more trading days during the 30 consecutive trading days preceding the date on which the Company sends notice of such redemption to the holders of the 2022 Convertible Notes. At maturity or redemption, if not earlier converted, the Company will pay 109% of the principal amount of the 2022 Convertible Notes maturing or being redeemed, together with accrued and unpaid interest, in cash. The 2022 Convertible Notes contain customary events of default (as defined in the 2022 Convertible Note purchase agreement), the occurrence of which could result in the acceleration of all amounts due under the 2022 Convertible Notes. These events of default include, among others, certain failures to pay amounts due on the 2022 Convertible Notes, to deliver the consideration due upon conversion or to settle uninsured judgments, decrees or orders exceeding $10.0 million, and certain defaults on other indebtedness for money borrowed of at least $10.0 million, insolvency-related events and breaches of representations, subject, in some cases, to a cure period. The 2022 Convertible Notes also contain covenants restricting the Company’s ability to incur additional indebtedness for borrowed money or convertible preferred stock and to pay dividends or make distributions on the Company’s equity interests, subject to certain exceptions. As of December 31, 2020, the Company was in full compliance with these covenants and there were no events of default under the 2022 Convertible Notes. The 2022 Convertible Notes are accounted for in accordance with ASC Subtopic 470-20, Debt with Conversion and Other Options The Company granted the holders of the 2022 Convertible Notes certain registration rights requiring the Company to register, under the Securities Act of 1933, as amended, the resale of the shares of common stock issuable upon conversion or settlement of the 2022 Convertible Notes. On April 13, 2020, the Company entered into an amendment (the “Second Amendment”) to the 2022 Convertible Note Purchase Agreement, dated as of February 29, 2016 (the “Note Purchase Agreement”), which amended the definition of Restricted Payment to exclude any payment (including a premium) to a counterparty under a Permitted Bond Hedge Transaction (as defined in the Note Purchase Agreement). The Second Amendment also added to the Note Purchase Agreement a definition of Permitted Bond Hedge Transaction, with such definition including any capped call option (or substantively equivalent derivative transaction) relating to the Company’s common stock purchased by it in connection with any issuance of indebtedness or convertible indebtedness. The following table summarizes information about the components of the 2022 Convertible Notes as of December 31, 2020 and 2019 (in thousands): December 31, December 31, 2020 2019 Principal amount of the 2022 Convertible Notes $ 81,750 $ 81,750 Unamortized debt discount and debt issuance costs (1,865) (3,208) 2022 Convertible Notes $ 79,885 $ 78,542 Principal amount of the 2022 Convertible Notes - related parties $ 27,250 $ 27,250 Unamortized debt discount and debt issuance costs - related parties (622) (1,069) 2022 Convertible Notes - related parties $ 26,628 $ 26,181 Total 2022 Convertible Notes $ 106,513 $ 104,723 If the 2022 Convertible Notes were converted on December 31, 2020, the holders of the 2022 Convertible Notes would receive common shares with an aggregate value of $77.8 million based on the Company’s closing stock price of $17.38. The following table presents the components of interest expense of the 2022 Convertible Notes for the years ended December 31, 2020, 2019 and 2018 (in thousands): Year Ended December 31, 2020 2019 2018 Stated coupon interest $ 6,150 $ 6,150 $ 6,150 Accretion of debt discount and debt issuance costs 1,343 1,223 1,113 Interest expense $ 7,493 $ 7,373 $ 7,263 Stated coupon interest - related parties $ 2,050 $ 2,050 $ 2,050 Accretion of debt discount and debt issuance costs - related parties 448 407 371 Interest expense - related parties $ 2,498 $ 2,457 $ 2,421 Total interest expense $ 9,991 $ 9,830 $ 9,684 The remaining unamortized debt discount and debt offering costs related to the Company’s 2022 Convertible Notes of approximately $2.5 million as of December 31, 2020, will be amortized using the effective interest rate over the remaining term of the 2022 Convertible Notes of 1.25 years. The annual effective interest rate is 9.48% for the 2022 Convertible Notes. Future payments on the 2022 Convertible Notes as of December 31, 2020 are as follows (in thousands): Year ending December 31, 2021 8,200 2022 111,050 Total minimum payments 119,250 Less amount representing interest (10,250) 2022 Convertible Notes, principal amount 109,000 Less debt discount and debt issuance costs on 2022 Convertible Notes (2,487) Net carrying amount of 2022 Convertible Notes $ 106,513 Term Loan On January 7, 2019 (“the “Term Loan Closing Date”), the Company entered into a credit agreement (the “Term Loan”) with affiliates of Healthcare Royalty Partners (together, the “Lender”). The Term Loan consists of a six-year term loan facility for an aggregate principal amount of $75.0 million (the “Borrowings”). The obligations of the Company under the loan documents are guaranteed by the Company’s material domestic U.S. subsidiaries. The Borrowings under the Term Loan bear interest through maturity at 7.00% per annum plus three month LIBOR. Pursuant to the terms of the Term Loan, the interest rate was reduced to 6.75% per annum plus LIBOR as of January 1, 2020 as the consolidated net sales for UDENYCA® for the fiscal year ending December 31, 2019 were in excess of $250.0 million. Interest is payable quarterly in arrears and varies with LIBOR. 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. As of December 31, 2020, the effective interest rate is 10.47%. The Company is required to pay principal on the Borrowings in equal quarterly installments beginning on the four year anniversary of the Term Loan Closing Date (or, if consolidated net sales of UDENYCA® in the fiscal year ending December 31, 2021 are less than $375.0 million, beginning on the three year anniversary of the Term Loan Closing Date), with the outstanding balance to be repaid on January 7, 2025, the maturity date. The Company is also required to make mandatory prepayments of the Borrowings under the Term Loan, subject to specified exceptions, with the proceeds of asset sales, extraordinary receipts, debt issuances and specified other events including the occurrence of a change in control. If all or any of the Borrowings are prepaid or required to be prepaid under the Term Loan, then the Company shall pay, in addition to such prepayment, a prepayment premium equal to (i) with respect to any prepayment paid or required to be paid on or prior to the three year anniversary of the Credit Agreement Closing Date, 5.00% of the Borrowings prepaid or required to be prepaid, plus all required interest payments that would have been due on the Borrowings prepaid or required to be prepaid through and including the three year anniversary of the Term Loan Closing Date, (ii) with respect to any prepayment paid or required to be paid after the three year anniversary of the Term Loan Closing Date but on or prior to the four year anniversary of the Term Loan Closing Date, 5.00% of the Borrowings prepaid or required to be prepaid, (iii) with respect to any prepayment paid or required to be paid after the four year anniversary of the Term Loan Closing Date but on or prior to the five year anniversary of the Term Loan Closing Date, 2.50% of the Borrowings prepaid or required to be prepaid, and (iv) with respect to any prepayment paid or required to be prepaid thereafter, 1.25% of the Borrowings prepaid or required to be prepaid. In connection with the Term Loan, the Company paid a fee to the Lender of approximately $1.1 million at closing in the form of an original issue discount. Upon the prepayment or maturity of the Borrowings (or upon the date such prepayment or repayment is required to be paid), it is required to pay an additional exit fee in an amount equal to 4.00% of the total principal amount of the Borrowings. The obligations under the Term Loan are secured by a lien on substantially all of the Company’s and its Guarantors’ tangible and intangible property, including intellectual property. The Term Loan contains certain affirmative covenants, negative covenants and events of default, including, covenants and restrictions that among other things, restrict the ability of the Company and its subsidiaries to, incur liens, incur additional indebtedness, make loans and investments, engage in mergers and acquisitions, in asset sales, and declare dividends or redeem or repurchase capital stock. Additionally, the consolidated net sales for UDENYCA® must not be lower than $70.0 million for the fiscal year ending December 31, 2019, (b) $125.0 million for the fiscal year ending December 31, 2020, and (c) $150.0 million for each fiscal year thereafter. A failure to comply with these covenants could permit the Lender under the Term Loan to declare the Borrowings, together with accrued interest and fees, to be immediately due and payable. On April 13, 2020, the Company entered into an amendment to the Term Loan, which amended the Term Loan’s indebtedness covenant such that the Company could incur Convertible Bond Indebtedness (as defined in the credit agreement governing the Term Loan) in an amount not to exceed the greater of $230.0 million or 20% of the Company’s market capitalization. The following table summarizes information about the components of the Term Loan (in thousands): December 31, December 31, 2020 2019 Principal amount of the Term Loan $ 75,000 $ 75,000 Unamortized debt discount and debt issuance costs (519) (1,337) Term Loan $ 74,481 $ 73,663 The following table presents the components of interest expense: Year Ended December 31, 2020 December 31, 2019 Stated coupon interest $ 7,053 $ 7,063 Accretion of debt discount and debt issuance costs 818 709 Interest expense $ 7,871 $ 7,772 The remaining unamortized debt discount and debt offering costs related to the Term Loan of approximately $0.5 million as of December 31, 2020, will be amortized using the effective rate over the remaining term of the Term Loan of 4 years. Future payments on the Term Loan as of December 31, 2020 are as follows (in thousands): Year ending December 31, 2021 7,034 2022 7,034 2023 39,187 2024 36,072 2025 11,348 Total minimum payments 100,675 Less amount representing interest (22,675) Term Loan, gross 78,000 Less debt discount and debt issuance costs on Term Loan (3,519) Net carrying amount of Term Loan $ 74,481 9. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2020 | |
Commitments and Contingencies. | |
Commitments and Contingencies | 9. Commitments and Contingencies Purchase Commitments The Company entered into agreements with a vendor to secure raw materials and a CMO to manufacture its commercial supply of UDENYCA®. As of December 31, 2020, the Company’s contractual obligations under the terms of the agreements are as follows (in thousands): Years ending December 31, 2021 40,963 2022 15,946 2023 9,753 Total obligations $ 66,662 The Company enters into contracts in the normal course of business with contract research organizations for preclinical studies and clinical trials and CMO for the manufacture of drug materials. The contracts are cancellable, with varying provisions regarding termination. If a contract with a specific vendor were to be terminated, the Company would 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. Contingencies On March 3, 2017, Amgen filed an action against the Company, KBI BioPharma Inc., the Company’s employee Howard S. Weiser and Does 1-20 in the Superior Court of the State of California, County of Ventura. The complaint alleges that the Company engaged in unfair competition and improperly solicited and hired certain former Amgen employees in order to acquire and access trade secrets and other confidential information belonging to Amgen. On June 1, 2017, Amgen filed a Second Amended Complaint, which alleges as to Coherus (i) unfair competition under California Business and Professions Code Section 17200 et seq., (ii) misappropriation of trade secrets, (iii) aiding and abetting breach of duty of loyalty and (iv) tortious interference with contract. As to defendant Weiser, the Second Amended Complaint alleges (i) unfair competition under California Business and Professions Code Section 17200 et seq., (ii) misappropriation of trade secrets, (iii) breach of contract, (iv) violation of Penal Code Section 502 and (v) breach of duty of loyalty. KBI BioPharma Inc. is not named as a defendant in the Second Amended Complaint. The Second Amended Complaint seeks injunctive relief and monetary damages. On May 2, 2019, the Company and Amgen settled the trade secret action brought by Amgen. The details of the settlement are confidential but the Company will continue to market UDENYCA® 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 would assess 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. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2020 | |
Leases | |
Leases | 10. In July 2015, the Company entered into the office space for its corporate headquarters in Redwood City, California under an operating lease agreement, which has been subject to amendments to secure additional space such that the total headquarters leased space is approximately 47,789 square feet. The Lease Agreement, provides for certain limited rent abatement and contains annual scheduled rent increases over the lease term. The lease terminates in September 2024 one The Company also leases laboratory facilities in Camarillo, California. In October 2019, the Company entered into a new laboratory facility lease (“New Camarillo Lease”) of approximately 25,017 square feet in a new location in Camarillo, California as the current Camarillo leases terminated in June 2020 and December 2020. The New Camarillo Lease provides for certain limited rent abatement and annual scheduled rent increases over the lease term. The lease commenced in January 2020 and terminates in May 2027 one The Company determined that the above facility leases were operating leases. The options to extend the lease terms for these leases were not included as part of the right-of-use asset or lease liability as the Company was not reasonably certain it would exercise those options. In 2019, the Company entered into a vehicle lease agreement, pursuant to which it currently leases 42 vehicles. Delivery of the vehicles commenced during the first quarter of 2020. The term of each leased vehicle commences upon the delivery of the vehicle and is for a period of 36 months. The vehicles leased under this arrangement were classified as finance leases. In determining the present value of the lease payments, the Company used the incremental borrowing rate based on the information available on January 1, 2019 (adoption date of ASC 842) for the leases that commenced prior to that date. For all other leases, the Company used the incremental borrowing rate on the lease commencement or the lease modification date, as applicable. The supplemental information related to Company’s leases is as follows (in thousands): December 31, December 31, Assets Balance Sheet Classification 2020 2019 Operating lease Operating lease right-of-use assets $ 9,956 $ 10,649 Finance lease Property and equipment, net 1,451 — Total leased assets $ 11,407 $ 10,649 December 31, December 31, Liabilities Balance Sheet Classification 2020 2019 Operating lease liabilities, current Other current liabilities $ 2,573 $ 2,196 Operating lease liabilities, non-current Lease liabilities, non-current 9,073 10,256 Total operating lease liabilities $ 11,646 $ 12,452 Finance lease liabilities, current Other current liabilities $ 560 $ — Finance lease liabilities, non-current Lease liabilities, non-current 875 — Total finance lease liabilities $ 1,435 $ 0 Operating lease costs were $3.1 million, $2.4 million and $2.2 million for the years ended December 31, 2020, 2019 and 2018, respectively. Cash paid for amounts included in the measurement of the operating lease liabilities for the years ended December 31, 2020 and 2019 was $3.2 million and $2.7 million, respectively, and was included in net cash used in operating activities in the consolidated statements of cash flows. Finance lease costs and cash paid for amounts included in the measurement of finance lease liabilities were immaterial during the years ended December 31, 2020 and 2019. As of December 31, 2020, the maturities of the operating lease liabilities were as follows (in thousands): Years ending December 31, Operating leases Finance leases 2021 3,425 626 2022 3,293 626 2023 3,438 285 2024 2,889 — 2025 and beyond 699 — Total lease payments 13,744 1,537 Less imputed interest (2,098) (102) Operating lease liabilities $ 11,646 $ 1,435 As of December 31, 2020 and 2019, the weighted average remaining lease term for operating leases was 4.1 years and 4.7 years, respectively. The weighted average discount rate used to determine the operating lease liabilities was 8.1% and 8.2% as of December 31, 2020 and 2019, respectively. The weighted average remaining lease term for finance leases was 2.4 years as of December 31, 2020. The weighted average discount rate used to determine the finance lease liabilities was 5.8% as of December 31, 2020. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2020 | |
Equity [Abstract] | |
Stockholders' Equity | 11. Common Stock Offerings In January 2016, the Company’s shelf registration statement on Form S-3 (File No. 333-208625) (the “Shelf Registration Statement”) was declared effective by the SEC. As of January 18, 2019, the Company’s Shelf Registration Statement expired. On October 28, 2016, the Company entered into a sales agreement (the “Sales Agreement”) with Cowen to sell shares of the Company’s common stock, with aggregate gross sales proceeds of up to $100,000,000, from time to time, through an at-the-market equity offering program under which Cowen acted as its sales agent (the “ATM Offering Program”). Cowen was entitled to compensation for its services equal to 3.0% of the gross proceeds of any shares of common stock sold through Cowen under the Sales Agreement. The Company had no obligation to sell any shares under the Sales Agreement, and could at any time suspend solicitation and offers under the Sales Agreement. The shares were issued pursuant to the Company’s Shelf Registration Statement. The Company filed a prospectus supplement, dated October 28, 2016, with the SEC in connection with the offer and sale of the shares pursuant to the Sales Agreement. In 2018, the Company issued and sold 1,799,504 shares of common stock at a weighted average price of $12.14 per share through its ATM Offering Program and received total gross proceeds of $21.8 million. After deducting commission of $0.7 million and offering expense of $0.1 million, the net proceeds were $21.0 million. In January 2019, the Company issued and sold 761,130 shares of common stock at a weighted average price of $11.17 per share through its ATM Program and received total gross proceeds of $8.5 million. After deducting commission of $0.3 million, the net proceeds were $8.2 million. As of January 18, 2019, the Company’s Shelf Registration Statement expired and accordingly the ATM Offering Program was terminated. In May 2018, the Company completed an underwritten public offering of 5,948,274 shares of its common stock at a price to the public of $14.50 per shares, which includes the closing of the full exercise of the underwriters’ option to purchase an additional 775,861 shares of common stock. The Company received total gross proceeds from the offering of $86.3 million. After deducting underwriting discounts and commissions of $5.2 million and offering expenses of $0.3 million, the net proceeds were $80.8 million. |
Stock Option Plans and Stock-Ba
Stock Option Plans and Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2020 | |
Stock Option Plans and Stock-Based Compensation | |
Stock Option Plans and Stock-Based Compensation | 12. Equity Incentive Plans In October 2014, the Company’s board of directors and its stockholders adopted the 2014 Equity Incentive Plan (the “2014 Plan”), which became effective upon the closing of the Company’s IPO on November 6, 2014. The 2014 Plan is subject to automatic annual increases in the number of shares available for issuance on the first business day of each fiscal year equal to four percent (4%) of the number of shares of the Company’s common stock outstanding as of such date or a lesser number of shares as determined by the Company’s board of directors. All remaining shares under the Company’s 2010 Stock Plan (the “2010 Plan”) were transferred to the 2014 Plan upon adoption and any additional shares than would otherwise return to the 2010 Plan as a result of forfeiture, termination or expiration of the awards will return to the 2014 Plan. The 2014 Plan provided for the Company to grant shares and/or options to purchase shares of common stock to employees, directors, consultants and other service providers. As of December 31, 2020, the Company had 240,467 shares of common stock available for future issuance. In June 2016, the Company adopted the 2016 Employment Commencement Incentive Plan (the “2016 Plan”). The 2016 Plan is designed to comply with the inducement exemption contained in Nasdaq’s Rule 5635(c)(4), which provides for the grant of non-qualified stock options, restricted stock units, restricted stock awards, performance awards, dividend equivalents, deferred stock awards, deferred stock units, stock payment and stock appreciation rights to a person not previously an employee or director of the Company, or following a bona fide period of non-employment, as an inducement material to the individual’s entering into employment with the Company. As of December 31, 2020, the Company had 238,589 shares of common stock available for future issuance for new employees. The 2016 Plan does not provide for any annual increases in the number of shares available. Stock Options Incentive stock options and non-statutory stock options may be granted with exercise prices of not less than the fair value of the common stock on the date of grant. These stock options generally vest over four years, expire in ten years from the date of grant and are generally exercisable after vesting. The following table sets forth the summary of option activities under the 2016 and 2014 Plans: Options Outstanding Weighted- Number of Average Options Exercise Price Balances at December 31, 2019 17,811,671 $ 14.582 Granted - at fair value 4,535,550 17.890 Exercised (1,704,764) 10.008 Forfeited/Cancelled (1,627,622) 18.926 Balances at December 31, 2020 19,014,835 $ 15.409 Additional information related to the status of options as of December 31, 2020 is summarized as follows: Weighted- Weighted- Average Aggregate Average Remaining Intrinsic Number of Exercise Contractual Terms Value (in Options Price (Years) thousands) Options outstanding 19,014,835 15.409 6.60 72,425,719 Options vested and exercisable 11,866,172 14.974 5.54 58,173,433 During the years ended December 31, 2020, 2019 and 2018, the estimated weighted-average grant-date fair value of options granted was $10.94, $9.52 and $7.77 per share, respectively, and the aggregate intrinsic value of options exercised was $14.6 million, $10.3 million and $4.9 million, respectively. The Company recognized stock-based compensation expenses of $30.3 million, $31.4 million and $33.3 million for the years ended December 31, 2020, 2019 and 2018, respectively, related to stock options. As of December 31, 2020, total unrecognized stock-based compensation expenses related to unvested employee stock options was $68.5 million, which is expected to be recognized on a straight-line basis over a weighted-average period of approximately 2.6 years. Restricted Stock Units In August 2017, the Compensation Committee of the Company’s board of directors approved the granting of restricted stock units (“RSUs”) to its employees. RSUs are share awards that entitle the holder to receive freely tradable shares of our common stock upon vesting. The RSUs cannot be transferred and are subject to forfeiture if the holder’s employment terminates prior to the release of the vesting restrictions. The Company’s RSUs generally vest over two The following table sets forth the summary of RSUs activity, under the 2014 Plan: RSUs Outstanding Weighted-Average Number of Grant Date Fair RSUs Value Balances at December 31, 2019 104,750 $ 19.544 RSUs granted 1,186,124 17.860 RSUs vested (223,767) 18.380 RSUs cancelled (57,450) 17.969 Balances at December 31, 2020 1,009,657 $ 17.913 The total fair value of RSUs vested was $4.1 million, $2.7 million and $1.0 million during the years ended December 31, 2020, 2019 and 2018 respectively. The total estimated grant date fair value of RSUs was $21.2 million, $4.3 million and $78,000 granted during the years ended December 31, 2020, 2019 and 2018, respectively. The estimated weighted-average grant-date fair value per share of RSUs granted during the years ended December 31, 2020, 2019 and 2018 was $17.86, $15.11 and $15.60, respectively. The Company recognized stock-based compensation expense related to RSUs of $6.5 million, $0.8 million and $0.7 million for the years ended December 31, 2020, 2019 and 2018, respectively. As of December 31, 2020, total unrecognized stock-based compensation expenses related to unvested RSUs was $12.6 million, which is expected to be recognized on a straight-line basis over a weighted-average period of approximately 1.8 years. Employee Stock Purchase Plan In October 2014, the Company’s board of directors and its stockholders approved the establishment of the 2014 Employee Stock Purchase Plan (“ESPP”). The ESPP provides for annual increases in the number of shares available for issuance on the first business day of each fiscal year equal to the lesser of one percent (1%) of the number of shares of the Company’s common stock outstanding as of such date or a number of shares as determined by the Company’s board of directors. The ESPP had 2,752,449 shares of common stock available for future issuance as of December 31, 2020. Eligible employees may purchase common stock at 85% of the lesser of the fair market value of the Company’s common stock on the first or last day of the offering period. The offering periods of ESPP are on May 16 November 16 Stock-Based Compensation The stock-based compensation expense is reflected in the consolidated statements of operations as follows (in thousands): Year Ended December 31, 2020 2019 2018 Cost of goods sold (1) $ 583 $ 108 $ — Research and development 13,837 12,912 15,339 Selling, general and administrative 23,740 20,571 19,458 Stock-based compensation expense $ 38,160 $ 33,591 $ 34,797 Capitalized stock-based compensation expense into inventory $ 1,460 $ 1,735 $ — (1) Stock-based compensation capitalized into inventory is recognized as cost of sales when the related product is sold. Valuation Assumptions of Awards Granted to Employees The Company estimated the fair value of each stock option and awards granted under the ESPP on the date of grant using the Black-Scholes option-pricing model. The following table illustrates the weighted average assumptions for the Black-Scholes option-pricing model used in determining the fair value of the awards during the years ended December 31, 2020, 2019 and 2018: Year Ended December 31, 2020 2019 2018 Expected term (years) Stock options 6.10 6.00 6.00 ESPP 0.50 0.50 0.50 Expected volatility Stock options 68 % 69 % 71 % ESPP 58 % 61 % 71 % Risk-free interest rate Stock options 1.09 % 2.29 % 2.77 % ESPP 0.13 % 1.89 % 2.40 % Expected dividend yield Stock options — % — % — % ESPP — % — % — % Expected Term: Expected Volatility: Risk-Free Interest Rate: Expected Dividends: 401(k) Retirement Plan In 2019, the Company’s Compensation Committee approved the Company’s matching of the employees 401(k) |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2020 | |
Income Taxes | |
Income Taxes | 13. The components of income (loss) before income taxes are as follows (in thousands): Year Ended December 31, 2020 2019 2018 Domestic $ 133,615 $ 92,584 $ (208,843) Foreign 2,092 190 (496) Total $ 135,707 $ 92,774 $ (209,339) Provision for (benefit from) income taxes (in thousands): Year Ended December 31, 2020 2019 2018 Current Federal $ — $ — $ — State 3,463 2,942 — Foreign — — — Subtotal $ 3,463 $ 2,942 $ — Deferred Federal $ — $ — $ — State — — — Foreign — — — Subtotal $ — $ — $ — Provision for income taxes $ 3,463 $ 2,942 $ — Income tax provision for the years ended December 31, 2020 and 2019 of $3.5 million and $2.9 million, respectively, primarily relates to state taxes in jurisdictions outside of California, for which the Company has a limited operating history. There was no income tax provision for the year ended December 31, 2018 due to the Company’s history of losses and valuation of allowances against the deferred tax assets. A reconciliation of the statutory U.S. federal rate to the Company’s effective tax rate is as follows: Year Ended December 31, 2020 2019 2018 Percent of pre-tax income: U.S. federal statutory income tax rate 21.00 % 21.00 % 21.00 % State taxes, net of federal benefit 1.95 1.51 0.16 Foreign rate differences (0.32) (0.04) (0.05) Permanent items 0.36 (0.64) 0.15 Research and development credit (4.76) (4.77) 2.61 Stock based compensation costs 1.31 1.26 (0.84) Other (0.28) (0.71) 3.07 Change in valuation allowance (16.71) (14.44) (26.10) Effective income tax rate 2.55 % 3.17 % — % Significant components of the Company’s net deferred tax assets as of December 31, 2020 and 2019 consist of the following (in thousands): December 31, 2020 2019 Net operating loss carryforwards $ 94,043 $ 138,663 Research and development credits 49,965 43,879 Depreciation and amortization 9,672 7,230 Stock-based compensation 25,983 22,807 Sales related accruals 16,404 7,137 Other accruals 8,013 6,927 Gross deferred tax assets 204,080 226,643 Right-of-use asset (2,566) (2,396) In-process research and development (589) (589) Gross deferred tax liabilities (3,155) (2,985) Total net deferred tax asset 200,925 223,658 Less valuation allowance (200,925) (223,658) Net deferred tax assets $ — $ — ASC 740 (“ASC 740”) requires that the tax benefit of net operating losses, temporary differences and credit carry forwards be recorded as an asset to the extent that management assesses that realization is “more likely than not.” Realization of the future tax benefits is dependent on our ability to generate sufficient taxable income within the carry forward period. Because of our recent history of operating losses, management believes that recognition of the deferred tax assets arising from the above-mentioned future tax benefits is currently not likely (as defined in ASC 740) to be realized and, accordingly, has provided a valuation allowance. The valuation allowance decreased by $22.7 million and $13.4 million during the years ended December 31, 2020 and 2019, respectively and increased by $54.6 million during the year ended December 31, 2018. As of December 31, 2020, the Company had federal net operating loss carryforwards of approximately $430.3 million, which will start to expire beginning in 2036, and various state net operating loss carryforwards of approximately $44.6 million, which have various expiration dates beginning in 2031. As of December 31, 2020, the Company had federal research and development credit carryforwards for federal income tax purposes of approximately $48.2 million, which will start to expire in 2031, and state research and development credit carryforwards of approximately $18.0 million, which can be carried forward indefinitely. In assessing the realizability of deferred tax assets, the Company considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which the temporary differences representing net future deductible amounts become deductible. Due to the weight of the negative evidence, which is primarily its history of losses outweighing other positive evidence, the Company has determined that it is more likely than not that its federal net deferred tax assets and certain state net deferred tax assets will not be realized, and therefore, the federal and certain state net deferred tax assets are fully offset by a valuation allowance at December 31, 2020 and 2019. The deferred tax assets were primarily comprised of net operating losses, tax credit carryforwards and stock-based compensation. Utilization of the net operating loss carryforwards and credits may be subject to a substantial annual limitation due to the ownership change limitations provided by Section 382 of the Internal Revenue Code of 1986, as amended, and similar state provisions. The annual limitation may result in the expiration of net operating losses and credits before utilization. Under the new enacted tax law, the carry forward period of net operating losses generated from 2018 forward is indefinite. However, the carryforward period for net operating losses generated prior to 2018 remains the same. Therefore, the annual limitation may result in the expiration of certain net operating losses and tax credit carryforwards before their utilization. The Company files U.S. California and other state income tax returns with varying statutes of limitations. The tax years from 2011 forward remain open to examination due to the carryover of unused net operating losses and tax credits. A reconciliation of the Company’s unrecognized tax benefits for the years ended December 31, 2020, 2019 and 2018 is as follows (in thousands): Year Ended December 31, 2020 2019 2018 Balance at beginning of year $ 11,603 $ 18,115 $ 15,682 Additions based on tax positions related to current year 1,749 1,206 1,276 Additions (reductions) for tax positions of prior years (109) (7,718) 1,157 Balance at end of year $ 13,243 $ 11,603 $ 18,115 As of December 31, 2020, 2019 and 2018, the Company had approximately $13.2 million, $11.6 million and $18.1 million, respectively, of unrecognized benefits, none of which would currently affect the Company’s effective tax rate if recognized due to the Company’s deferred tax assets being fully offset by a valuation allowance. The Company does not believe there will be any material changes in its unrecognized tax positions over the next twelve months. During the years ended December 31, 2020, 2019 and 2018 the Company did not recognize accrued interest and penalties related to unrecognized tax benefits. The Company does not anticipate a material adjustment of unrecognized tax benefits during the next 12 months that impacts the rate for tax positions of prior years. |
Net Income (Loss) Per Share Att
Net Income (Loss) Per Share Attributable to Coherus | 12 Months Ended |
Dec. 31, 2020 | |
Net Income (Loss) Per Share Attributable to Coherus | |
Net Income (Loss) Per Share Attributable to Coherus | 14. The following table sets forth the computation of the basic and diluted net income (loss) per share attributable to the Company (in thousands, except share and per share data): Years Ended December 31, 2020 2019 2018 Basic net income (loss) per share Numerator: Net income (loss) attributable to Coherus $ 132,244 $ 89,833 $ (209,339) Denominator: Weighted-average common shares outstanding 71,411,705 69,679,916 65,034,827 Basic net income (loss) per share attributable to Coherus $ 1.85 $ 1.29 $ (3.22) Diluted net income (loss) per share Numerator: Net income (loss) attributable to Coherus $ 132,244 $ 89,833 $ (209,339) Add interest expense on 2026 convertible notes, net of tax 3,307 — — Numerator for diluted (loss) net income per share attributable to Coherus 135,551 89,833 (209,339) Denominator: Denominator for basic net income (loss) per share attributable to Coherus 71,411,705 69,679,916 65,034,827 Add effect of potential dilutive securities: Stock options, including purchases from contributions to ESPP 3,455,646 3,491,272 — Restricted stock units 167,597 14,755 — Shares issuable upon conversion of 2026 Convertible Notes 8,456,950 — — Denominator for diluted net income (loss) per share attributable to Coherus 83,491,898 73,185,943 65,034,827 Diluted net income (loss) per share attributable to Coherus $ 1.62 $ 1.23 $ (3.22) The following outstanding dilutive potential shares were excluded from the calculation of diluted net income (loss) per share attributable to Coherus due to their anti-dilutive effect: Year Ended December 31, 2020 2019 2018 Stock options, including purchases from contributions to ESPP 9,521,403 10,412,471 14,743,547 Restricted stock units 7,689 22,068 44,387 Shares issuable upon conversion of 2022 Convertible Notes 4,473,871 4,473,871 4,473,871 Total 14,002,963 14,908,410 19,261,805 |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2020 | |
Related Party Transactions | |
Related Party Transactions | 15. Related Party Transactions Transactions Associated with Medpace Agreement A prior member of the Company’s board of directors is also the president and chief executive officer of Medpace Inc. (“Medpace”). As such, Medpace was deemed to be a related party until the director’s resignation on March 1, 2018. As a result, the Company no longer reflects balances and transactions associated with Medpace as related party in its consolidated financial statements as of March 1, 2018. The Company recognized $1.5 million during year ended December 31, 2018 for services rendered by Medpace within research and development expense in the consolidated statements of operations. Convertible Notes — Related Parties In February 2016, the Company issued Convertible Notes to certain related parties (some companies affiliated with members of the Company’s board of directors), for an aggregate principal amount of $25.0 million (see Note 8 for related party disclosure). InteKrin Acquisition In February 2014, the Company completed the acquisition of the InteKrin for total consideration of $5.0 million. Mr. Dennis M. Lanfear, the chief executive officer of the Company, was the chairman of the board and acting president of InteKrin at the time of the acquisition. As such, the InteKrin acquisition was a related party transaction. Mr. Lanfear also owned 10% of the outstanding securities of InteKrin Russia, a majority owned subsidiary of InteKrin. In September 2018, InteKrin acquired the outstanding 17.5% of securities of InteKrin Russia held by its non-controlling owners for $0.7 million. As a result of this purchase of the non-controlling ownership in InteKrin Russia, Mr. Lanfear, who was one of the non-controlling stockholders of InteKrin Russia, received $0.4 million in consideration for his shares. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2020 | |
Subsequent Events | |
Subsequent Events | 16. Subsequent Events 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 will pay $150.0 million upfront for exclusive rights to toripalimab in the United States and Canada, options in these territories to Junshi Biosciences’ anti-TIGIT antibody and 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 toripalimb 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 milestones, including up to $290.0 million for attainment of certain sales thresholds. If the Company exercise its options, it will be obligated to pay an option exercise fee for each of the anti-TIGIT antibody and the IL-2 cytokine of $35.0 million per program. Additionally, for each exercised option, the Company will be obligated to pay Junshi Biosciences an 18% royalty on net sales and up to an aggregate $255.0 million for the achievement of various milestones, including up to $170.0 million for 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, and will pay for a portion of these co-development activities up to a maximum of $25.0 million per licensed compound per year. Closing of the Collaboration Agreement is subject to clearance under the Hart-Scott Rodino Antitrust Improvements Act (the “HSR Act”). 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, the Company has agreed to issue 2,491,988 unregistered shares of its common stock, at a price per share of $20.0643, for an aggregate value of approximately $50.0 million, to Junshi Biosciences as a portion of the consideration for the Collaboration. |
Basis of Presentation and Sum_2
Basis of Presentation and Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2020 | |
Basis of Presentation and Summary of Significant Accounting Policies | |
Basis of Presentation | Basis of Consolidation The accompanying consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”). The accompanying consolidated financial statements include the accounts of Coherus and its wholly owned subsidiaries as of December 31, 2020: Coherus Intermediate Corp, InteKrin Therapeutics Inc. (“InteKrin”) and InteKrin’s wholly-owned subsidiary, InteKrin Russia. Unless otherwise specified, references to the Company are references to Coherus and its consolidated subsidiaries. All intercompany transactions and balances have been eliminated upon consolidation. |
Liquidity | Liquidity As of December 31, 2020, the Company had an accumulated deficit of $762.8 million and cash and cash equivalents of $541.2 million. The Company had $132.2 million in net income for the year ended December 31, 2020. The Company believes that its current available cash, cash equivalents and cash collected from UDENYCA® sales will be sufficient to fund its planned expenditures and meet the Company’s obligations for at least 12 months following its financial statement issuance date . |
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 reported in the financial statements. Management uses significant judgment when making estimates including, but not limited to: those related to revenue recognition, including determining the nature and timing of satisfaction of performance obligations, and determining the standalone selling price of performance obligations, and variable consideration such as rebates, chargebacks, sales returns and sale allowances, as well as milestones included in collaboration and license arrangements; related to its stock-based compensation, valuation of deferred tax assets, impairment of goodwill and long-lived assets, the valuation of acquired intangible assets, valuation and reserves for inventory, clinical trial accruals, contingent consideration, convertible notes valuation, as well as certain accrued liabilities. Management bases its estimates on historical experience and on other various assumptions that are believed to be reasonable under the circumstances. These estimates form the basis for making judgments about the carrying values of assets and liabilities when these values are not readily apparent from other sources. Accounting estimates and judgements are inherently uncertain and the actual results could differ from these estimates. During the second quarter of 2020, the Company identified that certain of its commercial payer invoices were erroneously overstated. The Company received a refund of $7.5 million from these payers related to fiscal year 2019 which resulted in an increase in net product revenue of $7.5 million for the year ended December 31, 2020. The refund adjustment resulted in an increase in basic and diluted net income per share of $0.11 and $0.09, respectively, during the year ended December 31, 2020. Accrued commercial payer rebates of $27.9 million and $14.0 million were recorded in accrued rebates, fees and reserve as of December 31, 2020 and December 31, 2019, respectively, in the consolidated balance sheet. |
Foreign Currency | Foreign Currency The functional currency of InteKrin Russia, which the Company acquired in February 2014, is the Russian Ruble. Accordingly, the financial statements of this subsidiary are translated into U.S. dollars using appropriate exchange rates. Unrealized gains or losses on translation are recognized in accumulated other comprehensive loss in the consolidated balance sheet. For the years ended December 31, 2020, 2019 and 2018, the foreign exchange gains and losses recorded in other income, net in the consolidated statements of operations were a net loss of $333,000, net gain of $239,000 and a net loss of $571,000, respectively. |
Segment Reporting and Revenue by Geographic Region | Segment Reporting and Revenue by Geographic Region The Company operates and manages its business as one reportable and operating segment, which is the business of developing and commercializing biosimilar products and, as part of the InteKrin acquisition, small molecules. The Company’s chief executive officer, who is the chief operating decision maker, reviews financial information on an aggregate basis for purposes of allocating resources and evaluating financial performance. All revenue is generated in the United States of America and all Long-lived assets are primarily maintained in the United States of America. |
Cash, Cash Equivalents and Restricted Cash | Cash, Cash Equivalents and Restricted Cash Cash, cash equivalents and restricted cash are comprised of cash and highly liquid investments with remaining maturities of 90 days or less at the date of purchase. The Company limits cash investments to financial institutions with high credit standings; therefore, management believes that there is no significant exposure to any credit risk in the Company’s cash, cash equivalents and restricted cash. The following table provides a reconciliation of cash, cash equivalents and restricted cash within the consolidated balance sheets and which, in aggregate, represent the amount reported in the consolidated statements of cash flows (in thousands): Year Ended December 31, 2020 2019 2018 Cash and cash equivalents $ 541,158 $ 177,668 $ 72,356 Restricted cash — — 50 Restricted cash - non-current 440 240 785 Total cash, cash equivalents and restricted cash $ 541,598 $ 177,908 $ 73,191 Restricted cash – non-current consists of deposits for a letter of credit that the Company has provided to secure its obligations under certain facility and other leases. The Company classifies the up-front and milestone payments related to licensing arrangements as cash flows from investing activities in its consolidated statements of cash flows. |
Investments in Marketable Securities | Investments in Marketable Securities 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 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 are reported as a component of accumulated comprehensive income (loss), with the exception of unrealized losses believed to be related to credit losses, which, if any, are recognized through 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 and declines in value judged to be other than temporary, if any, on available-for-sale securities are included in other income, net, based on the specific identification method. For the years ended December 31, 2020, 2019 and 2018, interest income from marketable securities was $0.6 million, $1.6 million and $1.4 million, respectively. |
Trade Receivables | Trade Receivables Trade receivables are recorded net of allowances for chargebacks, chargeback prepayments, cash discounts for prompt payment and credit losses. The Company estimates an allowance for expected credit losses by considering factors such as historical experience, credit quality, the age of the accounts receivable balances, and current economic conditions that may affect a customer’s ability to pay. The corresponding expense for the credit loss allowance is reflected in selling, general and administrative expenses. The credit loss allowance was immaterial as of December 31, 2020. |
Concentration of Credit Risk | Concentration of Credit Risk The Company’s financial instruments that are exposed to concentration of credit risk consist primarily of cash, cash equivalents and restricted cash. The Company maintains its cash in bank accounts, which at times exceed federally insured limits. The Company attempts to minimize the risks related to cash, cash equivalents and restricted cash by investing in money markets with a broad and diverse range of financial instruments. The investment portfolio is maintained in accordance with the Company’s investment policy, which defines allowable investments, specifies credit quality standards and limits the credit exposure of any single issuer. The Company also maintains restricted cash in money market funds that invest primarily in U.S. Treasury securities. The Company has not recognized any losses from credit risks on such accounts during any of the periods presented. The Company believes it is not exposed to significant credit risk on its cash and money market funds. The Company is subject to credit risk from trade receivables related to the product sales in the United States. To date, the Company has not experienced significant losses with respect to the collection of trade receivables. The Company believes that its allowance for doubtful accounts was adequate at December 31, 2020. The Company entered into a strategic commercial supply agreement with KBI Biopharma (“KBI”) for the supply of UDENYCA®. The Company currently has not engaged back-up suppliers or vendors for this single-sourced service. If KBI is not able to manufacture the supply needed in the quantities and timeframe required, the Company may not be able to supply the product in a timely manner. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments Fair value accounting is applied to all financial assets and liabilities and non-financial assets and liabilities that are recognized or disclosed at fair value in the financial statements on a recurring basis. |
Inventory | Inventory Prior to the regulatory approval of the product candidates, the Company incurred expenses for the manufacture of drug product that could potentially be available to support the commercial launch of its products. The Company began to capitalize inventory costs associated with UDENYCA® after receiving regulatory approval for UDENYCA® in November 2018 when it was determined that the inventory had a probable future economic benefit. Inventory is stated at the lower of cost or estimated net realizable value with cost determined under the first-in first-out method. Inventory costs include third-party contract manufacturing, third-party packaging services, freight, labor costs for personnel involved in the manufacturing process, and indirect overhead costs. The Company primarily uses actual costs to determine the cost basis for inventory. The determination of whether inventory costs will be realizable requires management review of the expiration dates of UDENYCA® compared to its forecasted sales. If actual market conditions are less favorable than projected by management, write-downs of inventory may be required, which would be recorded as cost of goods sold in the consolidated statement of operations. |
Property and Equipment | Property and Equipment Property and equipment is stated at cost less accumulated depreciation and amortization. Maintenance and repairs are charged to expense as incurred, and costs of improvements are capitalized. Depreciation and amortization is recognized using the straight-line method over the following estimated useful lives: Computer equipment and software 3 years Furniture and fixtures 5 years Machinery and equipment 5 years Leasehold improvements Shorter of lease term or useful life |
Impairment of Long Lived Assets and Acquired Intangible Asset | Impairment of Long Lived Assets and Acquired Intangible Asset The Company reviews long-lived assets, including property and equipment, and indefinite-lived intangible assets for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets may not be fully recoverable. An impairment loss would be recognized when the estimated undiscounted future cash flows expected to result from the use of the asset and its eventual disposition is less than its carrying amount. Impairment, if any, is measured as the amount by which the carrying value of a long-lived asset exceeds its fair value. There were no impairments recorded during the year ended December 31, 2020. For the years ended December 31, 2019 and 2018, the Company recorded an impairment of property and equipment of $0.1 million and $3.9 million, respectively, in research and development within the statement of operations. The intangible assets of $2.6 |
Goodwill | Goodwill Goodwill represents the excess of the purchase price over the fair value of the net tangible and intangible assets acquired. The Company tests goodwill for impairment at least annually or more frequently if events or changes in circumstances indicate that this asset may be impaired. The goodwill test is based on our single operating segment and reporting unit structure. The Company compares the fair value of its reporting unit to its carrying value. If the carrying value of the net assets assigned to the reporting unit exceeds the fair value of the reporting unit, then the Company would need to determine the implied fair value of the reporting unit’s goodwill. If the carrying value of the reporting unit’s goodwill exceeds its implied fair value, then the Company would record an impairment loss equal to the difference. No goodwill impairment was identified through December 31, 2020. |
Accrued Research and Development Expenses | Accrued Research and Development Expense Clinical trial costs are a component of research and development expense. The Company accrues and expenses clinical trial activities performed by third parties based upon actual work completed in accordance with agreements established with clinical research and manufacturing organizations and clinical sites. The Company determines the actual costs through monitoring patient enrollment, discussions with internal personnel and external service providers regarding the progress or stage of completion of trials or services and the agreed-upon fee to be paid for such services. |
Net Product Revenue | Net Product Revenue The Company accounts for sales of UDENYCA® under Topic 606 Revenue from Contracts with Customers Product Sales Discounts and Allowances Revenue from product sales is recorded at the net sales price (“transaction price”), which includes estimates of variable consideration for which reserves are established and that result from chargebacks, rebates, co-pay assistance, prompt-payment discounts, returns and other allowances that are offered within contracts between the Company and its Customers, Healthcare Providers, payers and GPOs relating to the sales of UDENYCA®. These reserves are based on the amounts earned or to be claimed on the related sales and are classified as reductions in trade receivables (if the amounts are payable to a Customer) or current liabilities (if the amounts are payable to a party other than a Customer). Where appropriate, these estimates take into consideration a range of possible outcomes that are probability-weighted for relevant factors such as historical experience, current contractual and statutory requirements, specifically known market events and trends, industry data and forecasted Customer buying and payment patterns. Overall, these reserves reflect the best estimates of the amount of consideration to which the Company is entitled based on the terms of its contracts. The amount of variable consideration that is included in the transaction price may be constrained, and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. The actual amount of consideration ultimately received may differ. If actual results in the future vary from the Company’s estimates, the estimates will be adjusted, which will affect the net product revenue in the period that such variances become known. Chargebacks: Discounts for Prompt Payment: Rebates: Co-payment Assistance: Product Returns: Other Allowances: |
Cost of Goods Sold | Cost of Goods Sold Cost of goods sold consists primarily of third-party manufacturing, distribution, and overhead costs associated with UDENYCA®. A portion of the costs of producing UDENYCA® sold to date was expensed as research and development prior to the FDA approval of UDENYCA® and, therefore, it is not reflected in the cost of goods sold. On May 2, 2019, the Company and Amgen Inc. and Amgen USA Inc. (collectively “Amgen”) settled a trade secret action brought by Amgen. As a result, cost of goods sold reflects a mid-single digit royalty on net product revenue, which began on July 1, 2019. The royalty cost will continue for five years pursuant to the settlement. Cost of goods sold for the year ended December 31, 2019, included write-off of prepaid manufacturing costs of $1.3 million due to the cancellation of certain manufacturing reservations, and $0.4 million due to the write-off of excess and obsolete inventory. There were no material inventory write-offs recorded during the years ended December 31, 2020 and 2018. |
Research and Development Expense | Research and Development Expense Research and development costs are charged to expense as incurred. Research and development expense includes, among other costs, salaries and other personnel-related costs, consultant fees, preclinical costs, cost to manufacture drug candidates, clinical trial costs and supplies, laboratory supply costs, upfront and milestone payments under the licensing agreements and facility-related costs. Costs incurred under agreements with third parties are charged to expense as incurred in accordance with the specific contractual performance terms of such agreements. Third-party costs include costs associated with manufacturing drug candidates, preclinical and clinical support activities. In certain cases, amounts received as reimbursement for research and development activities from the Company’s collaborators are recognized as a reduction in research and development expense when the Company engages in a research and development project, jointly with another party, with both parties incurring costs while actively participating in project activities and sharing costs and potential benefits of the arrangement. Costs incurred under arrangements where the Company provides research services approximate the amount of revenues recorded. Advance payments for goods or services to be received in the future to be utilized in research and development activities are deferred and capitalized. The capitalized amounts are expensed as the related goods are delivered or the services are rendered. The Company considers regulatory approval of product candidates to be uncertain, and product manufactured prior to regulatory approval may not be sold unless regulatory approval is obtained. The Company expenses manufacturing costs as incurred to research and development expense for product candidates prior to regulatory approval. If, and when, regulatory approval of a product is obtained, the Company will begin capitalizing manufacturing costs related to the approved product into inventory. Costs associated with the development, validation and scaling of manufacturing processes at new third party suppliers and regulatory registration of new third-party manufacturing facilities are recognized as research and development expenses. These costs generally comprise of all costs incurred in such activities prior to the process performance qualification (“PPQ”) production commencement stage at new manufacturing facilities. Costs incurred after the PPQ production commencement at new manufacturing facilities are capitalized as inventory as the regulatory approval at that point becomes probable and the net realizable value of the batches produced during this stage of the process is recoverable. |
License Agreements | License Agreements The Company has entered and may continue to enter into license agreements to access and utilize certain technology. To determine whether the licensing transactions should be accounted for as a business combination or as an asset acquisition, the Company makes certain judgments, which include assessing whether the acquired set of activities and assets would meet the definition of a business under the relevant accounting rules. If the acquired set of activities and assets does not meet the definition of a business, the transaction is recorded as an acquisition of assets and, therefore, any acquired IPR&D that does not have an alternative future use is charged to expense at the acquisition date. To date none of the Company’s license agreements have been considered to be the acquisition of a business. |
Selling, General and Administrative Expense | Selling, General and Administrative Expense Selling, general and administrative expenses are primarily comprised of compensation and benefits associated with sales and marketing, finance, human resources, legal, information technology and other administrative personnel, outside marketing, advertising and legal expenses and other general and administrative costs. The Company expenses the cost of advertising, including promotional expenses, as incurred. Advertising expenses were $3.8 million, $4.5 million and $2.8 million for the years ended December 31, 2020, 2019 and 2018, respectively. |
Stock-Based Compensation | Stock-Based Compensation The Company measures the cost of equity-based service awards based on the grant-date fair value of the award. The compensation cost is recognized as expense on a straight-line basis over the vesting period for options and restricted stock units (“RSU”). The Company accounts for forfeitures as they occur. On January 1, 2019, the Company adopted the ASU No. 2018-07, Improvements to Nonemployee Share-Based Payment Accounting The Company utilizes the Black-Scholes option-pricing model for estimating fair value of its stock options and ESPP granted. Option valuation models, including the Black-Scholes option-pricing model, require the input of highly subjective assumptions, and changes in the assumptions used can materially affect the grant-date fair value of an award. These assumptions include the risk-free rate of interest, expected dividend yield, expected volatility and the expected life of the award. For RSUs, the Company bases the fair value of awards on the closing market value of the common stock at the date of grant. |
Income Taxes | Income Taxes The Company uses the liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are determined based on the differences between the financial reporting and the tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. The Company must then assess the likelihood that the resulting deferred tax assets will be realized. A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized. Due to the Company’s lack of earnings history, the net deferred tax assets have been fully offset by a valuation allowance. The Company recognizes uncertain income tax positions at the largest amount that is more likely than not to be sustained upon audit by the relevant taxing authority. An uncertain income tax position will not be recognized if it has less than a 50% likelihood of being sustained. The Company does not expect its unrecognized tax benefits to change significantly over the next twelve months. The Company’s policy is to recognize interest and/or penalties related to income tax matters in income tax expense. The Company had accrued no amounts for interest and penalties related to income tax matters in the Company’s consolidated balance sheet at December 31, 2020 and 2019. |
Operating and Finance Leases | Operating and Finance Leases The Company adopted ASU 2016-02, Leases guidance, ASC Topic 840: Leases The Company determines if an arrangement is a lease at inception. Operating leases are included in operating lease right-of-use assets, other current liabilities, and lease liabilities, non-current in the consolidated balance sheets. The Lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise any such options. The Company recognizes operating lease expense for these leases on a straight-line basis over the term of the lease. In 2019, the Company entered into a vehicle lease agreement, pursuant to which it currently leases 42 vehicles. Delivery of the vehicles commenced during the first quarter of 2020. The term of each leased vehicle commences upon the delivery of the vehicle and is for a period of 36 months. The vehicles leased under this arrangement were classified as finance leases. Assets acquired under finance leases are included in property and equipment, net, other current liabilities, and lease liabilities, non-current in the consolidated balance sheets and are depreciated to operating expenses on a straight-line basis over their estimated useful lives. With the exception of initial adoption of the new lease standard, where the Company’s incremental borrowing rate used was the rate on the adoption date (January 1, 2019), the operating and finance lease ROU assets and the lease liabilities are recognized based on the present value of lease payments over the lease term at the lease commencement date. The Company uses its incremental borrowing rate based on the information available at the commencement date in determining the lease liabilities, as the Company's leases generally do not provide an implicit rate. |
Net Income (Loss) per Share Attributable to Coherus | Net Income (Loss) per Share Attributable to Coherus Basic net income (loss) per share attributable to Coherus is calculated by dividing the net income (loss) attributable to Coherus by the weighted-average number of shares of common stock outstanding for the period, without consideration for potential dilutive common shares. Diluted net income (loss) per share is computed by dividing the net income (loss) by the weighted average number of common shares outstanding for the period plus any diluted potential common shares outstanding for the period determined using the treasury stock method for options, RSUs and ESPP and using the if-converted method for the convertible notes (see Note 14). |
Comprehensive Income (Loss) | Comprehensive Income (Loss) Comprehensive income (loss) is composed of two components: net income (loss) and other comprehensive income (loss). Other comprehensive income (loss) refers to gains and losses that under U.S. GAAP are recorded as an element of stockholders’ equity (deficit), but are excluded from net income (loss). The Company’s other comprehensive income (loss) included foreign currency translation adjustments for the years ended December 31, 2020, 2019 and 2018. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements The following are the recent accounting pronouncements adopted by the Company in 2020: Effective January 1, 2020, the Company adopted ASU No. 2016-13, Financial Instruments — Credit Losses, (Topic 326): Measurement of Credit Losses on Financial Instruments ASU 2016-13) ASU 2016-13 also eliminates the concept of “other-than-temporary” impairment when evaluating available-for-sale debt securities and instead focuses on determining whether any impairment is a result of a credit loss or other factors. An entity will recognize an allowance for credit losses on available-for-sale debt securities, rather than an other-than-temporary impairment that reduces the cost basis of the investment. In January 2017, the FASB issued ASU No. 2017-04, Intangibles-Goodwill and Other: Simplifying the Test for Goodwill Impairment In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurements The following are the recent accounting pronouncements that the Company has not yet adopted: In August 2020, the FASB issued , Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging Contracts in Entity’s Own Equity (Subtopic 815-40) which reduces the number of accounting models for convertible debt instruments and convertible preferred stock as well as amends the derivatives scope exception for contracts in an entity’s own equity. effective for the Company on January 1, 2022, with early adoption permitted. The Company is currently evaluating the potential impact that this standard may have on its consolidated financial statements and related disclosures. The Company has reviewed other recent accounting pronouncements and concluded they are either not applicable to the business or that no material effect is expected on the consolidated financial statements as a result of future adoption. |
Basis of Presentation and Sum_3
Basis of Presentation and Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Basis of Presentation 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 within the consolidated balance sheets and which, in aggregate, represent the amount reported in the consolidated statements of cash flows (in thousands): Year Ended December 31, 2020 2019 2018 Cash and cash equivalents $ 541,158 $ 177,668 $ 72,356 Restricted cash — — 50 Restricted cash - non-current 440 240 785 Total cash, cash equivalents and restricted cash $ 541,598 $ 177,908 $ 73,191 |
Schedule of Estimated Useful Lives of Property Plant and Equipment | Computer equipment and software 3 years Furniture and fixtures 5 years Machinery and equipment 5 years Leasehold improvements Shorter of lease term or useful life |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
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 are as follows (in thousands): Fair Value Measurements December 31, 2020 Total Level 1 Level 2 Level 3 Financial Assets: Money market funds $ 538,673 $ 538,673 $ — $ — Restricted cash (money market funds) 440 440 — — Total financial assets $ 539,113 $ 539,113 $ — $ — Financial Liabilities: Contingent consideration $ 102 $ — $ — $ 102 Fair Value Measurements December 31, 2019 Total Level 1 Level 2 Level 3 Financial Assets: Money market funds $ 155,523 $ 155,523 $ — $ — Restricted cash (money market funds) 240 240 — — Total financial assets $ 155,763 $ 155,763 $ — $ — Financial Liabilities: Contingent consideration $ 102 $ — $ — $ 102 |
Summary of Changes in the Estimated Fair Value of Contingent Consideration | The following table sets forth a summary of changes in the estimated fair value of the contingent consideration (in thousands): Balance as of December 31, 2017 $ 3,290 Change in fair value of the contingent consideration liability (3,230) Balance as of December 31, 2018 60 Change in fair value of the contingent consideration liability 42 Balance as of December 31, 2019 102 Change in fair value of the contingent consideration liability — Balance as of December 31, 2020 $ 102 |
Inventory (Tables)
Inventory (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Inventory | |
Schedule of Inventory | The Company began capitalizing inventory in November 2018 once the FDA approved UDENYCA®. Inventory consisted of the following (in thousands): December 31, December 31, 2020 2019 Raw Materials $ 5,205 $ 5,089 Work in process 43,952 43,446 Finished goods 43,032 6,536 Total $ 92,189 $ 55,071 |
Schedule of Balance Sheet Classification | Balance sheet classification (in thousands): December 31, December 31, 2020 2019 Inventory $ 44,233 $ 9,807 Inventory, non-current 47,956 45,264 Total $ 92,189 $ 55,071 |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Organization and Operations | |
Schedule of Property and Equipment, Net | Property and equipment, net are as follows (in thousands): December 31, December 31, 2020 2019 Machinery and equipment $ 13,301 $ 12,611 Computer equipment and software 3,996 2,923 Furniture and fixtures 1,268 714 Leasehold improvements 5,830 4,388 Finance lease right of use assets 1,451 — Construction in progress 312 1,500 Total property and equipment 26,158 22,136 Accumulated depreciation and amortization (16,050) (16,296) Property and equipment, net $ 10,108 $ 5,840 |
Schedule of Accrued Liabilities | Accrued liabilities are as follows (in thousands): December 31, December 31, 2020 2019 Accrued clinical and manufacturing $ 11,365 $ 7,106 Accrued other 11,453 10,152 Accrued liabilities $ 22,818 $ 17,258 |
Revenue (Tables)
Revenue (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Revenue | |
Revenue by Significant Customer | Revenue by significant Customer was distributed as follows: Year Ended Year Ended December 31, 2020 December 31, 2019 Percent of Total Percent of Total McKesson 38 % 42 % AmeriSource-Bergen Corp 37 % 33 % Cardinal 23 % 23 % Others 2 % 2 % Total revenue 100 % 100 % |
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 (in thousands): Year Ended December 31, 2020 Chargebacks Other Fees, and Discounts Co-pay for Prompt Assistance Payment Rebates and Returns Total Balance at December 31, 2019 $ 35,159 $ 27,494 $ 24,494 $ 87,147 Provision related to sales made in: Current period 462,328 115,864 114,372 692,564 Prior period (1,336) (3,438) (6,288) (11,062) Payments and customer credits issued (455,571) (85,862) (103,818) (645,251) Balance at December 31, 2020 $ 40,580 $ 54,058 $ 28,760 $ 123,398 Year Ended December 31, 2019 Chargebacks Other Fees, and Discounts Co-pay for Prompt Assistance Payment Rebates and Returns Total Balance at December 31, 2018 $ — $ — $ — $ — Activity related to 2019 sales 226,901 46,810 70,775 344,486 Payments and customer credits issued (191,742) (19,316) (46,281) (257,339) Balance at December 31, 2019 $ 35,159 $ 27,494 $ 24,494 $ 87,147 |
Debt Obligations (Tables)
Debt Obligations (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
2026 Convertible Notes | |
Debt Instrument | |
Components of Convertible Notes | The following table summarizes information about the components of the 2026 Convertible Notes (in thousands): December 31, 2020 Principal amount of the 2026 Convertible Notes $ 230,000 Unamortized debt discount and debt issuance costs (6,971) Total 2026 Convertible Notes $ 223,029 |
Components of Interest Expense | The following table presents the components of interest expense related to 2026 Convertible Notes (in thousands): Year Ended December 31, 2020 Stated coupon interest $ 2,434 Accretion of debt discount and debt issuance costs 873 Total interest expense $ 3,307 |
Schedule of Future Payments on Debt | Future payments on the 2026 Convertible Notes as of December 31, 2020 are as follows (in thousands): Year ending December 31, 2021 3,450 2022 3,450 2023 3,450 2024 3,450 2025 and beyond 235,175 Total minimum payments 248,975 Less amount representing interest (18,975) 2026 Convertible Notes, principal amount 230,000 Less debt discount and debt issuance costs on 2026 Convertible Notes (6,971) Net carrying amount of 2026 Convertible Notes $ 223,029 |
8.2% Convertible Notes due 2022 | |
Debt Instrument | |
Components of Convertible Notes | The following table summarizes information about the components of the 2022 Convertible Notes as of December 31, 2020 and 2019 (in thousands): December 31, December 31, 2020 2019 Principal amount of the 2022 Convertible Notes $ 81,750 $ 81,750 Unamortized debt discount and debt issuance costs (1,865) (3,208) 2022 Convertible Notes $ 79,885 $ 78,542 Principal amount of the 2022 Convertible Notes - related parties $ 27,250 $ 27,250 Unamortized debt discount and debt issuance costs - related parties (622) (1,069) 2022 Convertible Notes - related parties $ 26,628 $ 26,181 Total 2022 Convertible Notes $ 106,513 $ 104,723 |
Components of Interest Expense | The following table presents the components of interest expense of the 2022 Convertible Notes for the years ended December 31, 2020, 2019 and 2018 (in thousands): Year Ended December 31, 2020 2019 2018 Stated coupon interest $ 6,150 $ 6,150 $ 6,150 Accretion of debt discount and debt issuance costs 1,343 1,223 1,113 Interest expense $ 7,493 $ 7,373 $ 7,263 Stated coupon interest - related parties $ 2,050 $ 2,050 $ 2,050 Accretion of debt discount and debt issuance costs - related parties 448 407 371 Interest expense - related parties $ 2,498 $ 2,457 $ 2,421 Total interest expense $ 9,991 $ 9,830 $ 9,684 |
Schedule of Future Payments on Debt | Future payments on the 2022 Convertible Notes as of December 31, 2020 are as follows (in thousands): Year ending December 31, 2021 8,200 2022 111,050 Total minimum payments 119,250 Less amount representing interest (10,250) 2022 Convertible Notes, principal amount 109,000 Less debt discount and debt issuance costs on 2022 Convertible Notes (2,487) Net carrying amount of 2022 Convertible Notes $ 106,513 |
Term Loan | |
Debt Instrument | |
Components of Interest Expense | The following table presents the components of interest expense: Year Ended December 31, 2020 December 31, 2019 Stated coupon interest $ 7,053 $ 7,063 Accretion of debt discount and debt issuance costs 818 709 Interest expense $ 7,871 $ 7,772 |
Schedule of Future Payments on Debt | Future payments on the Term Loan as of December 31, 2020 are as follows (in thousands): Year ending December 31, 2021 7,034 2022 7,034 2023 39,187 2024 36,072 2025 11,348 Total minimum payments 100,675 Less amount representing interest (22,675) Term Loan, gross 78,000 Less debt discount and debt issuance costs on Term Loan (3,519) Net carrying amount of Term Loan $ 74,481 |
Components of Term Loan | The following table summarizes information about the components of the Term Loan (in thousands): December 31, December 31, 2020 2019 Principal amount of the Term Loan $ 75,000 $ 75,000 Unamortized debt discount and debt issuance costs (519) (1,337) Term Loan $ 74,481 $ 73,663 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Commitments and Contingencies. | |
Schedule of Non-Cancellable Purchase Commitment | Years ending December 31, 2021 40,963 2022 15,946 2023 9,753 Total obligations $ 66,662 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Leases | |
Schedule of Balance Sheet Classification of Lease Assets and Liabilities | The supplemental information related to Company’s leases is as follows (in thousands): December 31, December 31, Assets Balance Sheet Classification 2020 2019 Operating lease Operating lease right-of-use assets $ 9,956 $ 10,649 Finance lease Property and equipment, net 1,451 — Total leased assets $ 11,407 $ 10,649 December 31, December 31, Liabilities Balance Sheet Classification 2020 2019 Operating lease liabilities, current Other current liabilities $ 2,573 $ 2,196 Operating lease liabilities, non-current Lease liabilities, non-current 9,073 10,256 Total operating lease liabilities $ 11,646 $ 12,452 Finance lease liabilities, current Other current liabilities $ 560 $ — Finance lease liabilities, non-current Lease liabilities, non-current 875 — Total finance lease liabilities $ 1,435 $ 0 |
Schedule of maturities of the operating and finance lease liabilities | As of December 31, 2020, the maturities of the operating lease liabilities were as follows (in thousands): Years ending December 31, Operating leases Finance leases 2021 3,425 626 2022 3,293 626 2023 3,438 285 2024 2,889 — 2025 and beyond 699 — Total lease payments 13,744 1,537 Less imputed interest (2,098) (102) Operating lease liabilities $ 11,646 $ 1,435 |
Stock Option Plans and Stock-_2
Stock Option Plans and Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Stock Option Plans and Stock-Based Compensation | |
Summary of Option Activities under 2016 and 2014 Plans | The following table sets forth the summary of option activities under the 2016 and 2014 Plans: Options Outstanding Weighted- Number of Average Options Exercise Price Balances at December 31, 2019 17,811,671 $ 14.582 Granted - at fair value 4,535,550 17.890 Exercised (1,704,764) 10.008 Forfeited/Cancelled (1,627,622) 18.926 Balances at December 31, 2020 19,014,835 $ 15.409 |
Summary of Additional Information Related to Status of Options | Additional information related to the status of options as of December 31, 2020 is summarized as follows: Weighted- Weighted- Average Aggregate Average Remaining Intrinsic Number of Exercise Contractual Terms Value (in Options Price (Years) thousands) Options outstanding 19,014,835 15.409 6.60 72,425,719 Options vested and exercisable 11,866,172 14.974 5.54 58,173,433 |
Summary of RSU Activity, under 2014 Plan | The following table sets forth the summary of RSUs activity, under the 2014 Plan: RSUs Outstanding Weighted-Average Number of Grant Date Fair RSUs Value Balances at December 31, 2019 104,750 $ 19.544 RSUs granted 1,186,124 17.860 RSUs vested (223,767) 18.380 RSUs cancelled (57,450) 17.969 Balances at December 31, 2020 1,009,657 $ 17.913 |
Schedule of Stock-Based Compensation Expense | The stock-based compensation expense is reflected in the consolidated statements of operations as follows (in thousands): Year Ended December 31, 2020 2019 2018 Cost of goods sold (1) $ 583 $ 108 $ — Research and development 13,837 12,912 15,339 Selling, general and administrative 23,740 20,571 19,458 Stock-based compensation expense $ 38,160 $ 33,591 $ 34,797 Capitalized stock-based compensation expense into inventory $ 1,460 $ 1,735 $ — (1) Stock-based compensation capitalized into inventory is recognized as cost of sales when the related product is sold. |
Schedule of Weighted Average Assumptions for Black-Scholes Option-Pricing Model Used in Determining Fair Value of Awards | Year Ended December 31, 2020 2019 2018 Expected term (years) Stock options 6.10 6.00 6.00 ESPP 0.50 0.50 0.50 Expected volatility Stock options 68 % 69 % 71 % ESPP 58 % 61 % 71 % Risk-free interest rate Stock options 1.09 % 2.29 % 2.77 % ESPP 0.13 % 1.89 % 2.40 % Expected dividend yield Stock options — % — % — % ESPP — % — % — % |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Income Taxes | |
Components of Income (Loss) Before Income Taxes | The components of income (loss) before income taxes are as follows (in thousands): Year Ended December 31, 2020 2019 2018 Domestic $ 133,615 $ 92,584 $ (208,843) Foreign 2,092 190 (496) Total $ 135,707 $ 92,774 $ (209,339) |
Schedule of Provision For (Benefit From) Income Taxes | Provision for (benefit from) income taxes (in thousands): Year Ended December 31, 2020 2019 2018 Current Federal $ — $ — $ — State 3,463 2,942 — Foreign — — — Subtotal $ 3,463 $ 2,942 $ — Deferred Federal $ — $ — $ — State — — — Foreign — — — Subtotal $ — $ — $ — Provision for income taxes $ 3,463 $ 2,942 $ — |
Reconciliation of Statutory U.S. Federal Rate | A reconciliation of the statutory U.S. federal rate to the Company’s effective tax rate is as follows: Year Ended December 31, 2020 2019 2018 Percent of pre-tax income: U.S. federal statutory income tax rate 21.00 % 21.00 % 21.00 % State taxes, net of federal benefit 1.95 1.51 0.16 Foreign rate differences (0.32) (0.04) (0.05) Permanent items 0.36 (0.64) 0.15 Research and development credit (4.76) (4.77) 2.61 Stock based compensation costs 1.31 1.26 (0.84) Other (0.28) (0.71) 3.07 Change in valuation allowance (16.71) (14.44) (26.10) Effective income tax rate 2.55 % 3.17 % — % |
Components of Net Deferred Tax Assets | Significant components of the Company’s net deferred tax assets as of December 31, 2020 and 2019 consist of the following (in thousands): December 31, 2020 2019 Net operating loss carryforwards $ 94,043 $ 138,663 Research and development credits 49,965 43,879 Depreciation and amortization 9,672 7,230 Stock-based compensation 25,983 22,807 Sales related accruals 16,404 7,137 Other accruals 8,013 6,927 Gross deferred tax assets 204,080 226,643 Right-of-use asset (2,566) (2,396) In-process research and development (589) (589) Gross deferred tax liabilities (3,155) (2,985) Total net deferred tax asset 200,925 223,658 Less valuation allowance (200,925) (223,658) Net deferred tax assets $ — $ — |
Reconciliation of Unrecognized Tax Benefits | A reconciliation of the Company’s unrecognized tax benefits for the years ended December 31, 2020, 2019 and 2018 is as follows (in thousands): Year Ended December 31, 2020 2019 2018 Balance at beginning of year $ 11,603 $ 18,115 $ 15,682 Additions based on tax positions related to current year 1,749 1,206 1,276 Additions (reductions) for tax positions of prior years (109) (7,718) 1,157 Balance at end of year $ 13,243 $ 11,603 $ 18,115 |
Net Income (Loss) Per Share A_2
Net Income (Loss) Per Share Attributable to Coherus (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Net Income (Loss) Per Share Attributable to Coherus | |
Computation of Basic and Diluted Net Income Per Share Attributable to the Company | The following table sets forth the computation of the basic and diluted net income (loss) per share attributable to the Company (in thousands, except share and per share data): Years Ended December 31, 2020 2019 2018 Basic net income (loss) per share Numerator: Net income (loss) attributable to Coherus $ 132,244 $ 89,833 $ (209,339) Denominator: Weighted-average common shares outstanding 71,411,705 69,679,916 65,034,827 Basic net income (loss) per share attributable to Coherus $ 1.85 $ 1.29 $ (3.22) Diluted net income (loss) per share Numerator: Net income (loss) attributable to Coherus $ 132,244 $ 89,833 $ (209,339) Add interest expense on 2026 convertible notes, net of tax 3,307 — — Numerator for diluted (loss) net income per share attributable to Coherus 135,551 89,833 (209,339) Denominator: Denominator for basic net income (loss) per share attributable to Coherus 71,411,705 69,679,916 65,034,827 Add effect of potential dilutive securities: Stock options, including purchases from contributions to ESPP 3,455,646 3,491,272 — Restricted stock units 167,597 14,755 — Shares issuable upon conversion of 2026 Convertible Notes 8,456,950 — — Denominator for diluted net income (loss) per share attributable to Coherus 83,491,898 73,185,943 65,034,827 Diluted net income (loss) per share attributable to Coherus $ 1.62 $ 1.23 $ (3.22) |
Outstanding Dilutive Potential Shares Excluded from Calculation of Diluted Net Income Per Share Attributable to Coherus | Year Ended December 31, 2020 2019 2018 Stock options, including purchases from contributions to ESPP 9,521,403 10,412,471 14,743,547 Restricted stock units 7,689 22,068 44,387 Shares issuable upon conversion of 2022 Convertible Notes 4,473,871 4,473,871 4,473,871 Total 14,002,963 14,908,410 19,261,805 |
Basis of Presentation and Sum_4
Basis of Presentation and Summary of Significant Accounting Policies - Additional information (Details) | May 02, 2020 | May 02, 2019 | Jan. 07, 2019 | Dec. 31, 2020USD ($)segment | Dec. 31, 2019USD ($)item | Dec. 31, 2018USD ($)$ / shares |
Organization And Operations [Line Items] | ||||||
Accumulated deficit | $ 762,754,000 | $ 894,998,000 | ||||
Cash and cash equivalents | 541,200,000 | |||||
Profit Loss | 132,244,000 | 89,833,000 | $ (209,409,000) | |||
Interest income from marketable securities | 600,000 | 1,600,000 | 1,400,000 | |||
Impairment of property and equipment | 100,000 | 3,900,000 | ||||
Intangible Assets Net Excluding Goodwill | 2,620,000 | 2,620,000 | ||||
Impairment of intangible assets excluding goodwill | 0 | |||||
Write-off of excess and obsolete inventory | 0 | 410,000 | 0 | |||
Advertising expenses | $ 3,800,000 | 4,500,000 | 2,800,000 | |||
Description of uncertain income tax position | An uncertain income tax position will not be recognized if it has less than a 50% likelihood of being sustained. | |||||
Accrued interest or Penalties | $ 0 | $ 0 | ||||
Number of Vehicles Leased | item | 42 | |||||
Term of leases | 36 months | |||||
Foreign exchange gain (loss) | $ (333,000) | $ 239,000 | $ (571,000) | |||
Number of reportable and operating segments | segment | 1 | |||||
InteKrin Therapeutics Inc | ||||||
Organization And Operations [Line Items] | ||||||
Impairment of goodwill | $ 0 | |||||
In Process Research and Development | InteKrin Therapeutics Inc | ||||||
Organization And Operations [Line Items] | ||||||
Intangible Assets Net Excluding Goodwill | $ 2,600,000 | 2,600,000 | ||||
Affiliates of Healthcare Royalty Partners (together, the "Lender") | Term Loan | ||||||
Organization And Operations [Line Items] | ||||||
Total term of the loan | 6 years | |||||
At-the-Market Equity Offering Program | ||||||
Organization And Operations [Line Items] | ||||||
Share price | $ / shares | $ 12.14 | |||||
Common stock, net proceeds | $ 21,000,000 | |||||
Amgen | ||||||
Organization And Operations [Line Items] | ||||||
Royalty payment term | 5 years | 5 years | ||||
Write-off of prepaid manufacturing costs | 1,300,000 | |||||
Write-off of excess and obsolete inventory | $ 400,000 |
Basis of Presentation and Sum_5
Basis of Presentation and Summary of Significant Accounting Policies - Use of Estimates (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | ||
Jun. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||||
Net income from refund received | $ 132,244 | $ 89,833 | $ (209,409) | |
Earnings Per Share Basic | $ 1.85 | $ 1.29 | $ (3.22) | |
Earnings Per Share Diluted | $ 1.62 | $ 1.23 | $ (3.22) | |
Commercial payer invoices erroneously overstated | Revision of Prior Period, Adjustment | ||||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||||
Net income from refund received | $ 7,500 | |||
Increase in net product revenue | $ 7,500 | |||
Earnings Per Share Basic | $ 0.11 | |||
Earnings Per Share Diluted | $ 0.09 | |||
Commercial payer invoices erroneously overstated | Accrued rebates, fees and reserve | ||||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||||
Accrued payer rebates | $ 27,900 | $ 14,000 |
Basis of Presentation and Sum_6
Basis of Presentation and Summary of Significant Accounting Policies - Summary of Revenue by Geographical Region (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Basis of Presentation and Summary of Significant Accounting Policies | |||
Net product revenue | $ 475,824 | $ 356,071 | $ 0 |
Basis of Presentation and Sum_7
Basis of Presentation and Summary of Significant Accounting Policies - Reconciliation of Cash, Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Basis of Presentation and Summary of Significant Accounting Policies | ||||
Cash and cash equivalents | $ 541,158 | $ 177,668 | $ 72,356 | |
Restricted cash | 50 | |||
Restricted cash, non-current | 440 | 240 | 785 | |
Total cash, cash equivalents and restricted cash | $ 541,598 | $ 177,908 | $ 73,191 | $ 127,756 |
Basis of Presentation and Sum_8
Basis of Presentation and Summary of Significant Accounting Policies - Schedule of Estimated Useful Lives of Property Plant and Equipment (Details) | 12 Months Ended |
Dec. 31, 2020 | |
Computer Equipment and Software | |
Property and Equipment, Net | |
Estimated useful lives | 3 years |
Furniture and Fixtures | |
Property and Equipment, Net | |
Estimated useful lives | 5 years |
Machinery and Equipment | |
Property and Equipment, Net | |
Estimated useful lives | 5 years |
Leasehold Improvements | |
Property and Equipment, Net | |
Estimated useful lives, description | Shorter of lease term or useful life |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) | 12 Months Ended | |||||||
Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017 | Apr. 30, 2020USD ($) | Apr. 13, 2020USD ($) | Jan. 07, 2019USD ($) | Feb. 29, 2016USD ($) | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||||||
Unrealized gains and losses on investments | $ 0 | |||||||
Fair Value, Assets, Level 1 to Level 2 Transfers, Amount | 0 | |||||||
Fair Value, Assets, Level 2 to Level 1 Transfers, Amount | 0 | |||||||
Fair Value, Liabilities, Level 1 to Level 2 Transfers, Amount | 0 | |||||||
Fair Value, Liabilities, Level 2 to Level 1 Transfers, Amount | 0 | |||||||
Fair Value, Measurement with Unobservable Inputs Reconciliation, Recurring Basis, Asset, Transfers, Net | 0 | |||||||
Fair Value, Measurement with Unobservable Inputs Reconciliation, Recurring Basis, Liability, Transfers, Net | $ 0 | |||||||
Business Combination Contingent Consideration Arrangements Change In Amount Of Contingent Consideration Liability1 | $ 42,000 | $ (3,230,000) | ||||||
2026 Convertible Notes | ||||||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||||||
Convertible notes, interest rate | 1.50% | 1.50% | ||||||
Aggregate principal amount | $ 230,000,000 | $ 230,000,000 | ||||||
Principal amount outstanding | 223,029,000 | |||||||
8.2% Convertible Notes due 2022 | ||||||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||||||
Convertible notes, interest rate | 8.20% | |||||||
Aggregate principal amount | $ 100,000,000 | |||||||
Principal amount outstanding | 106,513,000 | |||||||
Term Loan | ||||||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||||||
Aggregate principal amount | 75,000,000 | 75,000,000 | ||||||
Principal amount outstanding | 74,481,000 | 73,663,000 | ||||||
Other Income, Net | ||||||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||||||
Business Combination Contingent Consideration Arrangements Change In Amount Of Contingent Consideration Liability1 | 0 | 42,000 | 3,200,000 | |||||
Contingent Consideration | ||||||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||||||
Decrease in fair value of the compound transaction payment | 0 | $ 42,000 | $ (3,230,000) | |||||
Level 2 | 2026 Convertible Notes | ||||||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||||||
Debt instrument fair value | 269,100,000 | |||||||
Level 3 | 8.2% Convertible Notes due 2022 | ||||||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||||||
Debt instrument fair value | $ 113,700,000 | |||||||
Fair Value Measurements Recurring Basis | Level 3 | Measurement Input, Discount Rate | ||||||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||||||
Fair value investment measurement input | 20 | |||||||
Fair Value Measurements Recurring Basis | Level 3 | Measurement Input, Counterparty Credit Risk | ||||||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||||||
Fair value investment measurement input | 8 | |||||||
Fair Value Measurements Recurring Basis | Level 3 | Contingent Consideration | ||||||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||||||
Increase (decrease) in expected probability of compound transaction payment occurrence | 1.00% | |||||||
Expected probability of compound transaction payment occurrence | 33.00% | 10.00% | ||||||
Maximum | Term Loan | ||||||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||||||
Aggregate principal amount | $ 230,000,000 | |||||||
Affiliates of Healthcare Royalty Partners (together, the "Lender") | Term Loan | ||||||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||||||
Aggregate principal amount | $ 75,000,000 |
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 | Dec. 31, 2020 | Dec. 31, 2019 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | $ 539,113 | $ 155,763 |
Contingent Consideration | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial liabilities | 102 | 102 |
Level 1 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 539,113 | 155,763 |
Level 1 | Contingent Consideration | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial liabilities | 0 | |
Level 2 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 0 | |
Level 2 | Contingent Consideration | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial liabilities | 0 | |
Level 3 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 0 | |
Level 3 | Contingent Consideration | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial liabilities | 102 | 102 |
Money Market Funds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 538,673 | 155,523 |
Money Market Funds | Level 1 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 538,673 | 155,523 |
Money Market Funds | Level 2 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 0 | |
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 | 240 |
Restricted Cash (Money Market Funds) | Level 1 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | $ 440 | 240 |
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 - Summa
Fair Value Measurements - Summary of Changes in the Estimated Fair Value of Contingent Consideration (Details) - Contingent Consideration - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Fair Value Liabilities Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | |||
Beginning balance | $ 102 | $ 60 | $ 3,290 |
Change in fair value of the contingent consideration liability | 0 | 42 | (3,230) |
Ending balance | $ 102 | $ 102 | $ 60 |
Inventory - Schedule of Invento
Inventory - Schedule of Inventory (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Inventory | ||
Raw materials | $ 5,205 | $ 5,089 |
Work in process | 43,952 | 43,446 |
Finished goods | 43,032 | 6,536 |
Total | $ 92,189 | $ 55,071 |
Inventory - Schedule of Balance
Inventory - Schedule of Balance Sheet Classification (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Inventory | ||
Inventory | $ 44,233 | $ 9,807 |
Inventory, non-current | 47,956 | 45,264 |
Total | $ 92,189 | $ 55,071 |
Inventory - Additional Informat
Inventory - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Inventory [Line Items] | ||
Prepayment made for manufacturing services | $ 19,429 | $ 8,578 |
Other assets, non-current | 2,147 | 362 |
Contract manufacturing organization (CMO) | ||
Inventory [Line Items] | ||
Prepayment made for manufacturing services | 19,400 | 8,600 |
Other assets, non-current | 1,300 | |
Prepayments made to a CMO for manufacturing services for UDENYCA | 8,900 | 7,200 |
Prepayments made to a CMO For Other Research And Development Pipeline Program | $ 10,500 | $ 1,400 |
Prepayment conversion to inventory, period | 12 months |
Balance Sheet Components - Sche
Balance Sheet Components - Schedule of Property and Equipment, Net (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Property and Equipment, Net | ||
Total property and equipment | $ 26,158 | $ 22,136 |
Accumulated depreciation and amortization | (16,050) | (16,296) |
Property and equipment, net | 10,108 | 5,840 |
Machinery and Equipment | ||
Property and Equipment, Net | ||
Total property and equipment | 13,301 | 12,611 |
Computer Equipment and Software | ||
Property and Equipment, Net | ||
Total property and equipment | 3,996 | 2,923 |
Furniture and Fixtures | ||
Property and Equipment, Net | ||
Total property and equipment | 1,268 | 714 |
Leasehold Improvements | ||
Property and Equipment, Net | ||
Total property and equipment | 5,830 | 4,388 |
Finance lease right of use assets | ||
Property and Equipment, Net | ||
Total property and equipment | 1,451 | |
Construction in Progress | ||
Property and Equipment, Net | ||
Total property and equipment | $ 312 | $ 1,500 |
Balance Sheet Components - Addi
Balance Sheet Components - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Property and Equipment, Net | |||
Depreciation and amortization | $ 2,888 | $ 3,259 | $ 3,235 |
Impairment of property and equipment | 100 | 3,900 | |
Material impairments of property and equipment | $ 0 | $ 0 | |
Machinery and Equipment | Research and Development Expense. | |||
Property and Equipment, Net | |||
Impairment of property and equipment | $ 3,900 |
Balance Sheet Components - Sc_2
Balance Sheet Components - Schedule of Accrued Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Balance Sheet Components | ||
Accrued clinical and manufacturing | $ 11,365 | $ 7,106 |
Accrued other | 11,453 | 10,152 |
Accrued liabilities | $ 22,818 | $ 17,258 |
Revenue - Additional Informatio
Revenue - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Revenue | |||
Net product revenue | $ 475,824 | $ 356,071 | $ 0 |
Revenue - Revenue by Significan
Revenue - Revenue by Significant Customer (Details) - Net Product Revenue - Customer Concentration Risk | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Concentration Risk | ||
Percentage of total revenue | 100.00% | 100.00% |
McKesson | ||
Concentration Risk | ||
Percentage of total revenue | 38.00% | 42.00% |
AmeriSource-Bergen Corp | ||
Concentration Risk | ||
Percentage of total revenue | 37.00% | 33.00% |
Cardinal | ||
Concentration Risk | ||
Percentage of total revenue | 23.00% | 23.00% |
Others | ||
Concentration Risk | ||
Percentage of total revenue | 2.00% | 2.00% |
Revenue - Activities and Ending
Revenue - Activities and Ending Reserve Balances for Each Significant Category of Discounts and Allowances (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Accounts Notes And Loans Receivable | ||
Balance at December 31 | $ 87,147 | |
Provision related to sales made in: | ||
Current period | 692,564 | $ 344,486 |
Prior period | (11,062) | |
Payments and customer credits issued | (645,251) | (257,339) |
Balance at December 31 | 123,398 | 87,147 |
Chargebacks and Discounts for Prompt Payment | ||
Accounts Notes And Loans Receivable | ||
Balance at December 31 | 35,159 | |
Provision related to sales made in: | ||
Current period | 462,328 | 226,901 |
Prior period | (1,336) | |
Payments and customer credits issued | (455,571) | (191,742) |
Balance at December 31 | 40,580 | 35,159 |
Rebates | ||
Accounts Notes And Loans Receivable | ||
Balance at December 31 | 27,494 | |
Provision related to sales made in: | ||
Current period | 115,864 | 46,810 |
Prior period | (3,438) | |
Payments and customer credits issued | (85,862) | (19,316) |
Balance at December 31 | 54,058 | 27,494 |
Other Fees, Co-pay Assistance and Returns | ||
Accounts Notes And Loans Receivable | ||
Balance at December 31 | 24,494 | |
Provision related to sales made in: | ||
Current period | 114,372 | 70,775 |
Prior period | (6,288) | |
Payments and customer credits issued | (103,818) | (46,281) |
Balance at December 31 | $ 28,760 | $ 24,494 |
Licensing Arrangements (Details
Licensing Arrangements (Details) $ in Thousands, € in Millions | Jan. 13, 2020 | Nov. 04, 2019 | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | Dec. 31, 2019EUR (€) | Dec. 31, 2018USD ($) |
Collaborative Arrangements And Noncollaborative Arrangement Transactions | ||||||
Research and development expense | $ 142,759 | $ 94,188 | $ 110,239 | |||
Bioeq | Licensed Products | ||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | ||||||
Percentage of gross profits on sales | 50.00% | 50.00% | ||||
Bioeq | Maximum | Licensed Products | ||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | ||||||
Additional development and regulatory milestones | € | € 25 | |||||
Bioeq | Research and Development Expense. | ||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | ||||||
Upfront and milestone payment | $ 11,100 | € 10 | ||||
Innovent | Licensed Products | ||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | ||||||
Upfront and milestone payment | 5,000 | |||||
Maximum period to exercise option | 12 months | |||||
Innovent | Bevacizumab Licensed Product | ||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | ||||||
Research and development expense | 7,500 | |||||
Innovent | Rituxan option exercised | ||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | ||||||
Fees paid | 5,000 | |||||
Innovent | Technology transfer | ||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | ||||||
Fees paid | 10,000 | |||||
Innovent | Maximum | Bevacizumab Licensed Product | ||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | ||||||
Aggregate milestone payments | 40,000 | |||||
Innovent | Maximum | Rituximab Licensed Product | ||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | ||||||
Aggregate milestone payments | $ 40,000 | |||||
Percentage of sales shared | 20 | |||||
Daiichi Sankyo License Agreement | ||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | ||||||
Initial term of agreement | 10 years |
Debt Obligations - 1.5% Convert
Debt Obligations - 1.5% Convertible Senior Subordinated Notes due 2026 (Details) | Feb. 29, 2016 | Apr. 30, 2020USD ($)$ / sharesshares | Dec. 31, 2020USD ($)item$ / shares | Apr. 14, 2020$ / shares |
Debt Instrument | ||||
Proceeds from offering after deducting initial purchasers' fees and offering expenses | $ 222,156,000 | |||
Convertible notes, premium percentage | 9.00% | |||
2026 Convertible Notes | ||||
Debt Instrument | ||||
Aggregate principal amount | $ 230,000,000 | $ 230,000,000 | ||
Convertible notes, interest rate | 1.50% | 1.50% | ||
Proceeds from offering after deducting initial purchasers' fees and offering expenses | $ 222,200,000 | |||
Common shares at conversion | shares | 51.9224 | |||
Principal amount of notes converted into shares | $ 1,000 | |||
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, beginning on October 15, 2020, and will mature on April 15, 2026, unless earlier repurchased or converted. | |||
Debt instrument maturity date | Apr. 15, 2026 | |||
Convertible notes, premium percentage | 30.00% | |||
Convertible notes, covenant compliance | As of December 31, 2020, the Company was in full compliance with these covenants and there were no events of default under the 2026 Convertible Notes. | |||
Number of events in default | item | 0 | |||
Debt issuance costs | $ 900,000 | |||
Contractual term | 6 years | |||
Convertible notes, converted amount | $ 207,600,000 | |||
Closing stock, price per share | $ / shares | $ 17.38 | $ 14.815 | ||
Remaining unamortized debt discount and debt offering costs | $ 6,971,000 | |||
Effective interest rate | 2.11% | |||
Debt Instrument Term | 5 years 3 months 18 days |
Debt Obligations - Capped Call
Debt Obligations - Capped Call Transactions (Details) $ / shares in Units, $ in Millions | Apr. 14, 2020$ / shares | Dec. 31, 2020USD ($)item$ / shares |
2026 Convertible Notes | ||
Option Indexed to Issuer's Equity [Line Items] | ||
Closing stock, price per share | $ 14.815 | $ 17.38 |
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 | |
Number of initial purchasers | item | 1 | |
Initial cap price of capped call transactions | $ 25.9263 | |
Percentage of cap price | 75 | |
Closing stock, price per share | $ 14.815 | |
Reduction in additional paid-in-capital from capped call premium paid | $ | $ 18.2 |
Debt Obligations - 2026 Convert
Debt Obligations - 2026 Convertible Notes Components (Details) - 2026 Convertible Notes - USD ($) $ in Thousands | Dec. 31, 2020 | Apr. 30, 2020 |
Debt Instrument | ||
Principal amount of the Convertible Notes | $ 230,000 | $ 230,000 |
Unamortized debt discount and debt issuance costs | (6,971) | |
Total Convertible Notes | $ 223,029 |
Debt Obligations - 2026 Conve_2
Debt Obligations - 2026 Convertible Notes Interest Expense Components (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Debt Instrument | |||
Accretion of debt discount and debt issuance costs | $ 3,481 | $ 2,339 | $ 1,484 |
2026 Convertible Notes | |||
Debt Instrument | |||
Stated coupon interest | 2,434 | ||
Accretion of debt discount and debt issuance costs | 873 | ||
Total interest expense | $ (3,307) |
Debt Obligations - 2026 Conve_3
Debt Obligations - 2026 Convertible Notes Future Payments (Details) - 2026 Convertible Notes $ in Thousands | Dec. 31, 2020USD ($) |
Debt Instrument | |
2021 | $ 3,450 |
2022 | 3,450 |
2023 | 3,450 |
2024 | 3,450 |
2025 and beyond | 235,175 |
Total minimum payments | 248,975 |
Less amount representing interest | (18,975) |
Convertible Notes, principal amount | 230,000 |
Less debt discount and debt issuance costs on Convertible Notes | (6,971) |
Net carrying amount | $ 223,029 |
Debt Obligations - 8.2% Convert
Debt Obligations - 8.2% Convertible Notes due 2022 (Details) | Feb. 29, 2016USD ($)D$ / sharesshares | Dec. 31, 2020USD ($)$ / shares |
Debt Instrument | ||
Proceeds from issuance of Convertible Notes due 2026, net of issuance costs | $ 222,156,000 | |
Convertible notes, premium percentage | 9.00% | |
KKR Member | ||
Debt Instrument | ||
Aggregate principal amount | $ 20,000,000 | |
MX II Member | ||
Debt Instrument | ||
Aggregate principal amount | 4,000,000 | |
KMGCP Member | ||
Debt Instrument | ||
Aggregate principal amount | 1,000,000 | |
Affiliates of Healthcare Royalty Partners (together, the "Lender") | KKR Member | ||
Debt Instrument | ||
Aggregate principal amount | 75,000,000 | |
8.2% Convertible Notes due 2022 | ||
Debt Instrument | ||
Aggregate principal amount | $ 100,000,000 | |
Convertible notes, interest rate | 8.20% | |
Proceeds from issuance of Convertible Notes due 2026, net of issuance costs | $ 99,200,000 | |
Convertible notes, Issuance Cost | $ 800,000 | |
Interest rate description | The 2022 Convertible Notes bear 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, which commenced on March 31, 2016, and mature on March 31, 2022, unless earlier converted, redeemed or repurchased. If the Company fails to satisfy certain registration or reporting requirements, then additional interest will accrue on the 2022 Convertible Notes at a rate of up to 0.50% per annum in the aggregate. The 2022 Convertible Notes also bear a premium of 9% of their principal amount, which is payable when the 2022 Convertible Notes mature or are repurchased or redeemed by the Company. | |
Debt instrument maturity date | Mar. 31, 2022 | |
Common shares at conversion | shares | 44.7387 | |
Principal amount of notes converted into shares | $ 1,000 | |
Conversion price per common share | $ / shares | $ 22.35 | |
Percentage of applicable conversion price | 160.00% | |
Convertible trading days | D | 20 | |
Consecutive trading days | D | 30 | |
Percentage to pay in cash of the par value of notes | 109.00% | |
Minimum order amount to be settled | $ 10,000,000 | |
Minimum borrowings for indebtedness defaulters | $ 10,000,000 | |
Convertible notes, covenant compliance | As of December 31, 2020, the Company was in full compliance with these covenants and there were no events of default under the 2022 Convertible Notes | |
Convertible notes, converted amount | $ 77,800,000 | |
Closing stock, price per share | $ / shares | $ 17.38 | |
Remaining unamortized debt discount and debt offering costs | $ 2,487,000 | |
Amortized effective interest rate convertible notes period | 1 year 3 months | |
Effective interest rate | 9.48% | |
8.2% Convertible Notes due 2022 | Maximum | ||
Debt Instrument | ||
Additional interest to be accrued upon failure of registration or reporting requirements | 0.50% |
Debt Obligations - 2022 Convert
Debt Obligations - 2022 Convertible Notes Components (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 | Feb. 29, 2016 |
Debt Instrument | |||
Convertible Notes | $ 79,885 | $ 78,542 | |
8.2% Convertible Notes due 2022 | |||
Debt Instrument | |||
Principal amount of the Convertible Notes | $ 100,000 | ||
Unamortized debt discount and debt issuance costs | (2,487) | ||
2022 Convertible Notes | |||
Debt Instrument | |||
Total Convertible Notes | 106,513 | 104,723 | |
2022 Convertible Notes | Related Party Debt | |||
Debt Instrument | |||
Principal amount of the Convertible Notes | 27,250 | 27,250 | |
Unamortized debt discount and debt issuance costs | (622) | (1,069) | |
Convertible Notes | 26,628 | 26,181 | |
2022 Convertible Notes | Parent Company | |||
Debt Instrument | |||
Principal amount of the Convertible Notes | 81,750 | 81,750 | |
Unamortized debt discount and debt issuance costs | (1,865) | (3,208) | |
Convertible Notes | $ 79,885 | $ 78,542 |
Debt Obligations - 2022 Conve_2
Debt Obligations - 2022 Convertible Notes Interest Expense Components (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Debt Instrument | |||
Accretion of debt discount and debt issuance costs | $ 3,481 | $ 2,339 | $ 1,484 |
Total interest expense | 21,166 | 17,601 | 9,684 |
2026 Convertible Notes | |||
Debt Instrument | |||
Stated coupon interest | 2,434 | ||
Accretion of debt discount and debt issuance costs | 873 | ||
Interest expense | 3,307 | ||
2022 Convertible Notes | |||
Debt Instrument | |||
Total interest expense | 9,991 | 9,830 | 9,684 |
2022 Convertible Notes | Related Party Debt | |||
Debt Instrument | |||
Stated coupon interest | 2,050 | 2,050 | 2,050 |
Accretion of debt discount and debt issuance costs | 448 | 407 | 371 |
Interest expense | 2,498 | 2,457 | 2,421 |
2022 Convertible Notes | Parent Company | |||
Debt Instrument | |||
Stated coupon interest | 6,150 | 6,150 | 6,150 |
Accretion of debt discount and debt issuance costs | 1,343 | 1,223 | 1,113 |
Interest expense | $ 7,493 | $ 7,373 | $ 7,263 |
Debt Obligations - 2022 Conve_3
Debt Obligations - 2022 Convertible Notes Future Payments (Details) - 8.2% Convertible Notes due 2022 $ in Thousands | Dec. 31, 2020USD ($) |
Debt Instrument | |
2021 | $ 8,200 |
2022 | 111,050 |
Total minimum payments | 119,250 |
Less amount representing interest | (10,250) |
Convertible Notes, principal amount | 109,000 |
Less debt discount and debt issuance costs on Convertible Notes | (2,487) |
Net carrying amount | $ 106,513 |
Debt Obligations - Term Loan (D
Debt Obligations - Term Loan (Details) - Term Loan - USD ($) $ in Thousands | Apr. 13, 2020 | Jan. 07, 2019 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Jan. 01, 2020 |
Debt Instrument | ||||||
Aggregate principal amount | $ 75,000 | $ 75,000 | ||||
Effective interest rate | 10.47% | |||||
Net sales | 250,000 | |||||
Interest rate description | The Borrowings under the Term Loan bear interest through maturity at 7.00% per annum plus three month LIBOR. Pursuant to the terms of the Term Loan, the interest rate was reduced to 6.75% per annum plus LIBOR as of January 1, 2020 as the consolidated net sales for UDENYCA® for the fiscal year ending December 31, 2019 were in excess of $250.0 million. Interest is payable quarterly in arrears and varies with LIBOR. 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. As of December 31, 2020, the effective interest rate is 10.47%. | |||||
Payment terms | The Company is required to pay principal on the Borrowings in equal quarterly installments beginning on the four year anniversary of the Term Loan Closing Date (or, if consolidated net sales of UDENYCA® in the fiscal year ending December 31, 2021 are less than $375.0 million, beginning on the three year anniversary of the Term Loan Closing Date), with the outstanding balance to be repaid on January 7, 2025, the maturity date. | |||||
Debt instrument maturity date | Jan. 7, 2025 | |||||
Payment of closing fee to the lenders in form of origination issue discount | $ 1,100 | |||||
Percentage required to pay an additional exit fee on principal amount | 4.00% | |||||
Convertible notes, covenant compliance | The Term Loan contains certain affirmative covenants, negative covenants and events of default, including, covenants and restrictions that among other things, restrict the ability of the Company and its subsidiaries to, incur liens, incur additional indebtedness, make loans and investments, engage in mergers and acquisitions, in asset sales, and declare dividends or redeem or repurchase capital stock. Additionally, the consolidated net sales for UDENYCA® must not be lower than $70.0 million for the fiscal year ending December 31, 2019, (b) $125.0 million for the fiscal year ending December 31, 2020, and (c) $150.0 million for each fiscal year thereafter. A failure to comply with these covenants could permit the Lender under the Term Loan to declare the Borrowings, together with accrued interest and fees, to be immediately due and payable. | |||||
Consolidated net sales, 2020 | $ 125,000 | |||||
Consolidated net sales, thereafter | 150,000 | |||||
Unamortized debt discount and debt issuance costs on Term Loan | 519 | 1,337 | ||||
Remaining unamortized debt discount and debt offering costs | $ 519 | $ 1,337 | ||||
Amortized effective interest rate convertible notes period | 4 years | |||||
Paid on or Prior to the Three Year Anniversary of Closing Date | ||||||
Debt Instrument | ||||||
Effective interest rate | 5.00% | |||||
Prepayment premium, description | with respect to any prepayment paid or required to be paid on or prior to the three year anniversary of the Credit Agreement Closing Date, 5.00% of the Borrowings prepaid or required to be prepaid, plus all required interest payments that would have been due on the Borrowings prepaid or required to be prepaid through and including the three year anniversary of the Term Loan Closing Date | |||||
Paid after the Three Year but on or Prior to the Four Year Anniversary of Closing Date | ||||||
Debt Instrument | ||||||
Effective interest rate | 5.00% | |||||
Prepayment premium, description | with respect to any prepayment paid or required to be paid after the three year anniversary of the Term Loan Closing Date but on or prior to the four year anniversary of the Term Loan Closing Date, 5.00% of the Borrowings prepaid or required to be prepaid | |||||
Paid after the Four Year but on or Prior to the Five Year Anniversary of Closing Date | ||||||
Debt Instrument | ||||||
Effective interest rate | 2.50% | |||||
Prepayment premium, description | with respect to any prepayment paid or required to be paid after the four year anniversary of the Term Loan Closing Date but on or prior to the five year anniversary of the Term Loan Closing Date, 2.50% of the Borrowings prepaid or required to be prepaid | |||||
Paid Thereafter | ||||||
Debt Instrument | ||||||
Effective interest rate | 1.25% | |||||
Prepayment premium, description | with respect to any prepayment paid or required to be prepaid thereafter, 1.25% of the Borrowings prepaid or required to be prepaid | |||||
Maximum | ||||||
Debt Instrument | ||||||
Aggregate principal amount | $ 230,000 | |||||
Percentage Of Market Capitalization | 20.00% | |||||
Maximum | Scenario Forecast | ||||||
Debt Instrument | ||||||
Net sales | $ 375,000 | |||||
Minimum | ||||||
Debt Instrument | ||||||
Consolidated net sales, 2019 | $ 70,000 | |||||
LIBOR | ||||||
Debt Instrument | ||||||
Stated interest rate | 7.00% | 6.75% | ||||
Affiliates of Healthcare Royalty Partners (together, the "Lender") | ||||||
Debt Instrument | ||||||
Total term of the loan | 6 years | |||||
Aggregate principal amount | $ 75,000 |
Debt Obligations - Term Loan Co
Debt Obligations - Term Loan Components (Details) - Term Loan - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Debt Instrument | ||
Principal amount of the Term Loan | $ 75,000 | $ 75,000 |
Unamortized debt discount and debt issuance costs | (519) | (1,337) |
Net carrying amount | $ 74,481 | $ 73,663 |
Debt Obligations - Term Loan In
Debt Obligations - Term Loan Interest Expense Components (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Debt Instrument | |||
Accretion of debt discount and debt issuance costs | $ 3,481 | $ 2,339 | $ 1,484 |
Term Loan | |||
Debt Instrument | |||
Stated coupon interest | 7,053 | 7,063 | |
Accretion of debt discount and debt issuance costs | 818 | 709 | |
Interest expense | $ 7,871 | $ 7,772 |
Debt Obligations - Term Loan Fu
Debt Obligations - Term Loan Future Payments (Details) - Term Loan - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Debt Instrument | ||
2021 | $ 7,034 | |
2022 | 7,034 | |
2023 | 39,187 | |
2024 | 36,072 | |
2025 | 11,348 | |
Total minimum payments | 100,675 | |
Less amount representing interest | (22,675) | |
Term Loan, gross | 78,000 | |
Less debt discount and debt issuance costs on Convertible Notes | (3,519) | |
Net carrying amount | $ 74,481 | $ 73,663 |
Commitments and Contingencies -
Commitments and Contingencies - Schedule of Non-Cancellable Purchase Commitment (Details) $ in Thousands | Dec. 31, 2020USD ($) |
Commitments and Contingencies. | |
2021 | $ 40,963 |
2022 | 15,946 |
2023 | 9,753 |
Total obligations | $ 66,662 |
Commitments and Contingencies_2
Commitments and Contingencies - Additional Information (Details) | May 02, 2020 | May 02, 2019 |
Amgen | ||
Loss Contingencies | ||
Royalty payment term | 5 years | 5 years |
Leases - Additional Information
Leases - Additional Information (Details) $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Oct. 31, 2019ft² | Jul. 31, 2015ft² | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($)item | |
Lessee Lease Description | ||||
Number of vehicles leased | item | 42 | |||
Term of leases | 36 months | |||
Future minimum lease payments for the undelivered vehicles | $ | $ 1,537 | |||
Cash paid for amounts included in measurement of lease liabilities | $ | $ 3,200 | $ 2,700 | ||
Operating lease weighted average remaining term | 4 years 1 month 6 days | 4 years 8 months 12 days | ||
Operating lease Weighted average discount rate | 8.10% | 8.20% | ||
Finance lease weighted average remaining term | 2 years 4 months 24 days | |||
Finance lease Weighted average discount rate | 5.80% | |||
Corporate Headquarters Lease | ||||
Lessee Lease Description | ||||
Area of office space leased | ft² | 47,789 | |||
Lease Expiration Date | Sep. 1, 2024 | |||
Option to extend lease | true | |||
Term of optional lease renewal | 5 years | |||
New Camarillo Lease | ||||
Lessee Lease Description | ||||
Area of office space leased | ft² | 25,017 | |||
Lease Expiration Date | May 1, 2027 | |||
Option to extend lease | true | |||
Term of optional lease renewal | 5 years | |||
Vehicle Lease | ||||
Lessee Lease Description | ||||
Number of vehicles leased | item | 42 | |||
Term of leases | 36 months |
Leases - Schedule of Balance Sh
Leases - Schedule of Balance Sheet Classification of Lease Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Assets: | ||
Operating lease right-of-use assets | $ 9,956 | $ 10,649 |
Operating Lease, Right-of-Use Asset, Statement of Financial Position [Extensible List] | Operating lease right-of-use assets | Operating lease right-of-use assets |
Finance lease | $ 1,451 | |
Finance Lease, Right-of-Use Asset, Statement of Financial Position [Extensible List] | Property Plant And Equipment Net | Property Plant And Equipment Net |
Total leased assets | $ 11,407 | $ 10,649 |
Liabilities: | ||
Operating lease, liability, current | $ 2,573 | $ 2,196 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | Other Liabilities Current | Other Liabilities Current |
Operating lease liability noncurrent | $ 9,073 | $ 10,256 |
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | Operating and Finance Lease, Liability, Noncurrent | Operating and Finance Lease, Liability, Noncurrent |
Total operating lease liabilities | $ 11,646 | $ 12,452 |
Finance lease liabilities, current | $ 560 | |
Finance Lease, Liability, Current, Statement of Financial Position [Extensible List] | Other Liabilities Current | Other Liabilities Current |
Finance lease liabilities, non-current | $ 875 | |
Finance Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | Operating and Finance Lease, Liability, Noncurrent | Operating and Finance Lease, Liability, Noncurrent |
Total finance lease liabilities | $ 1,435 | $ 0 |
Leases - Operating Lease Costs
Leases - Operating Lease Costs (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Leases | |||
Operating lease costs | $ 3.1 | $ 2.4 | $ 2.2 |
Cash paid for amounts included in measurement of lease liabilities | $ 3.2 | $ 2.7 |
Leases - Schedule of Maturities
Leases - Schedule of Maturities of Operating and Finance Lease Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Operating leases | ||
2021 | $ 3,425 | |
2022 | 3,293 | |
2023 | 3,438 | |
2024 | 2,889 | |
2025 and beyond | 699 | |
Total lease payments | 13,744 | |
Less imputed interest | (2,098) | |
Total operating lease liabilities | 11,646 | $ 12,452 |
Finance leases | ||
2021 | 626 | |
2022 | 626 | |
2023 | 285 | |
Total lease payments | 1,537 | |
Less imputed interest | (102) | |
Total finance lease liabilities | $ 1,435 | $ 0 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Details) - USD ($) | Oct. 28, 2016 | Jan. 31, 2019 | May 31, 2018 | Dec. 31, 2018 |
At-the-Market Equity Offering Program | ||||
Class Of Stock | ||||
Common stock, shares issued and sold | 1,799,504 | |||
Share price | $ 12.14 | |||
Gross proceeds from issuance of common stock | $ 21,800,000 | |||
Underwriting discounts and commissions | 700,000 | |||
Offering expense | 100,000 | |||
Common stock, net proceeds | $ 21,000,000 | |||
At-the-Market Equity Offering Program | Cowen and Company LLC | ||||
Class Of Stock | ||||
Maximum amount of sales that agent may sell in shares of its common stock | $ 100,000,000 | |||
Percentage of gross sales proceeds of common stock payable as compensation | 3.00% | |||
Common stock, shares issued and sold | 761,130 | |||
Share price | $ 11.17 | |||
Gross proceeds from issuance of common stock | $ 8,500,000 | |||
Underwriting discounts and commissions | 300,000 | |||
Common stock, net proceeds | $ 8,200,000 | |||
Underwritten Public Offering | ||||
Class Of Stock | ||||
Common stock, shares issued and sold | 5,948,274 | |||
Gross proceeds from issuance of common stock | $ 86,300,000 | |||
Underwriting discounts and commissions | 5,200,000 | |||
Offering expense | 300,000 | |||
Common stock, net proceeds | $ 80,800,000 | |||
Closing stock, price per share | $ 14.50 | |||
Underwriters' Option to Purchase Additional Shares | ||||
Class Of Stock | ||||
Common stock, shares issued and sold | 775,861 |
Stock Option Plans and Stock-_3
Stock Option Plans and Stock-Based Compensation - Additional Information (Details) - USD ($) | Oct. 31, 2014 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Options granted, weighted-average grant-date fair value | $ 10.94 | $ 9.52 | $ 7.77 | |
Options exercised, aggregate intrinsic value | $ 14,600,000 | $ 10,300,000 | $ 4,900,000 | |
Stock-based compensation expense | 38,160,000 | $ 33,591,000 | 34,797,000 | |
Unrecognized stock-based compensation expenses related to stock options | $ 68,500,000 | |||
Unrecognized share-based compensation related to stock options, RSUs and ESPP, period for recognition | 2 years 7 months 6 days | |||
Share based payment options grants | 4,535,550 | |||
Weighted-average exercise price of options granted | $ 17.890 | |||
Expected dividend yield | $ 0 | |||
Defined contribution plan name | chrs:Plan401KMember | |||
Percentage of maximum contribution of annual compensation | 90.00% | |||
Percentage of employer matching contributions | 50.00% | |||
Employer matching contribution of each participant's contribution plan | $ 6,000 | |||
Compensation expense related to match plan | $ 800,000 | |||
Employee Stock Option | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Vesting period | 4 years | |||
Options, expiration period | 10 years | |||
Stock-based compensation expense | $ 30,300,000 | 31,400,000 | 33,300,000 | |
Restricted stock units | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Stock-based compensation expense | 6,500,000 | 800,000 | 700,000 | |
Unrecognized stock-based compensation expenses related to stock options | $ 12,600,000 | |||
Unrecognized share-based compensation related to stock options, RSUs and ESPP, period for recognition | 1 year 9 months 18 days | |||
Total fair value of RSUs vested | $ 4,100,000 | 2,700,000 | 1,000,000 | |
Total estimated grant date fair value | $ 21,200,000 | $ 4,300,000 | $ 78,000 | |
Estimated weighted-average grant-date fair value of RSUs granted | $ 17.86 | $ 15.11 | $ 15.60 | |
Restricted stock units | Minimum | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Vesting period | 2 years | |||
Restricted stock units | Maximum | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Vesting period | 3 years | |||
2014 Plan | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Percentage of shares available for issuance | 4.00% | |||
Common stock reserved for future issuance | 240,467 | |||
2014 Plan | Restricted stock units | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Estimated weighted-average grant-date fair value of RSUs granted | $ 17.860 | |||
Share based payment RSUs grants | 1,186,124 | |||
ESPP | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Common stock reserved for future issuance | 2,752,449 | |||
Stock-based compensation expense | $ 1,400,000 | $ 1,300,000 | $ 800,000 | |
Unrecognized share-based compensation related to stock options, RSUs and ESPP, period for recognition | 4 months 15 days | |||
Unrecognized stock-based compensation expenses related to unvested RSUs | $ 700,000 | |||
Percentage of purchase common stock of lesser of fair market value of common stock on first or last day of offering period by eligible employees | 85.00% | |||
Employee stock purchase plan offering period one | --05-16 | |||
Employee stock purchase plan offering period two | --11-16 | |||
ESPP | Minimum | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Percentage of shares reserve for issuance | 1.00% | |||
2016 Plan | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Common stock reserved for future issuance | 238,589 |
Stock Option Plans and Stock-_4
Stock Option Plans and Stock-Based Compensation - Summary of Option Activities under 2016 and 2014 Plans (Details) | 12 Months Ended |
Dec. 31, 2020$ / sharesshares | |
Stock Option Plans and Stock-Based Compensation | |
Number of Options, Beginning balance | shares | 17,811,671 |
Number of Options, Granted - at fair value | shares | 4,535,550 |
Number of Options, Exercised | shares | (1,704,764) |
Number of Options, Forfeited /Cancelled | shares | (1,627,622) |
Number of Options, Ending balance | shares | 19,014,835 |
Weighted-Average Exercise Price, Beginning balance | $ / shares | $ 14.582 |
Weighted-Average Exercise Price, Granted - at fair value | $ / shares | 17.890 |
Weighted-Average Exercise Price, Exercised | $ / shares | 10.008 |
Weighted-Average Exercise Price, Forfeited /Cancelled | $ / shares | 18.926 |
Weighted-Average Exercise Price, Ending balance | $ / shares | $ 15.409 |
Stock Option Plans and Stock-_5
Stock Option Plans and Stock-Based Compensation - Summary of Additional Information Related to Status of Options (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Stock Option Plans and Stock-Based Compensation | ||
Options outstanding, Number of Options | 19,014,835 | 17,811,671 |
Options vested and exercisable, Number of Options | 11,866,172 | |
Options outstanding, Weighted-Average Exercise Price | $ 15.409 | $ 14.582 |
Options vested and exercisable, Weighted-Average Exercise Price | $ 14.974 | |
Options outstanding, Weighted-Average Contractual Terms | 6 years 7 months 6 days | |
Options vested and exercisable, Weighted-Average Contractual Terms | 5 years 6 months 14 days | |
Options outstanding, Aggregate Intrinsic Value | $ 72,425,719 | |
Options vested and exercisable, Aggregate Intrinsic Value | $ 58,173,433 |
Stock Option Plans and Stock-_6
Stock Option Plans and Stock-Based Compensation - Summary of RSU Activity, under 2014 Plan (Details) - Restricted stock units - $ / shares | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Weighted-Average Grant Date Fair Value, RSU's granted | $ 17.86 | $ 15.11 | $ 15.60 |
2014 Plan | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Number of RSU's, Balances at December 31, 2019 | 104,750 | ||
Number of RSU's granted | 1,186,124 | ||
Number of RSU's vested | (223,767) | ||
Number of RSU's cancelled | (57,450) | ||
Number of RSU's, Balances at December 31, 2020 | 1,009,657 | 104,750 | |
Weighted-Average Grant Date Fair Value, Balances at December 31, 2019 | $ 19.544 | ||
Weighted-Average Grant Date Fair Value, RSU's granted | 17.860 | ||
Weighted-Average Grant Date Fair Value, RSU's Vested | 18.380 | ||
Weighted-Average Grant Date Fair Value, RSU's cancelled | 17.969 | ||
Weighted-Average Grant Date Fair Value, Balances at December 31, 2020 | $ 17.913 | $ 19.544 |
Stock Option Plans and Stock-_7
Stock Option Plans and Stock-Based Compensation - Stock-Based Compensation (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs | |||
Stock-based compensation expense | $ 38,160 | $ 33,591 | $ 34,797 |
Capitalized stock-based compensation expense into inventory | 1,460 | 1,735 | |
Cost of Goods Sold | |||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs | |||
Stock-based compensation expense | 583 | 108 | |
Research and Development Expense. | |||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs | |||
Stock-based compensation expense | 13,837 | 12,912 | 15,339 |
Selling, General and Administrative Expenses | |||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs | |||
Stock-based compensation expense | $ 23,740 | $ 20,571 | $ 19,458 |
Stock Option Plans and Stock-_8
Stock Option Plans and Stock-Based Compensation - Schedule of Weighted Average Assumptions for Black-Scholes Option-Pricing Model Used in Determining Fair Value of Awards (Details) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
ESPP | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Expected term (years) | 6 months | 6 months | 6 months |
Expected volatility | 58.00% | 61.00% | 71.00% |
Risk-free interest rate | 0.13% | 1.89% | 2.40% |
Employee Stock Option | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Expected term (years) | 6 years 1 month 6 days | 6 years | 6 years |
Expected volatility | 68.00% | 69.00% | 71.00% |
Risk-free interest rate | 1.09% | 2.29% | 2.77% |
Income Taxes - Components of In
Income Taxes - Components of Income (Loss) Before Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Components of income (loss) before income taxes | |||
Domestic | $ 133,615 | $ 92,584 | $ (208,843) |
Foreign | 2,092 | 190 | (496) |
Total | $ 135,707 | $ 92,774 | $ (209,339) |
Income Taxes - Provision for (B
Income Taxes - Provision for (Benefit From) Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Current | |||
State | $ 3,463 | $ 2,942 | |
Subtotal | 3,463 | 2,942 | |
Deferred | |||
Provision for income taxes | $ 3,463 | $ 2,942 | $ 0 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Operating Loss Carryforwards [Line Items] | ||||
Income tax provision | $ 3,463 | $ 2,942 | $ 0 | |
Increase (decrease) in valuation allowance | 22,700 | 13,400 | 54,600 | |
Unrecognized tax benefits, accrued interest and penalties accrued | 0 | 0 | 0 | |
Unrecognized tax benefits | 13,243 | $ 11,603 | $ 18,115 | $ 15,682 |
Federal | ||||
Operating Loss Carryforwards [Line Items] | ||||
Net operating loss carryforwards | $ 430,300 | |||
Net operating loss carryforwards expiration year | 2036 | |||
Tax credit carryforwards | $ 48,200 | |||
Tax credit carryforwards expiration year | 2031 | |||
State | ||||
Operating Loss Carryforwards [Line Items] | ||||
Net operating loss carryforwards | $ 44,600 | |||
Net operating loss carryforwards expiration year | 2031 | |||
Tax credit carryforwards | $ 18,000 |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Statutory U.S. Federal Rate (Details) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Percent of pre-tax income: | |||
U.S. federal statutory income tax rate | 21.00% | 21.00% | 21.00% |
State taxes, net of federal benefit | 1.95% | 1.51% | 0.16% |
Foreign rate differences | (0.32%) | (0.04%) | (0.05%) |
Permanent items | 0.36% | (0.64%) | 0.15% |
Research and development credit | (4.76%) | (4.77%) | 2.61% |
Stock based compensation costs | 1.31% | 1.26% | (0.84%) |
Other | (0.28%) | (0.71%) | 3.07% |
Change in valuation allowance | (16.71%) | (14.44%) | (26.10%) |
Effective income tax rate | 2.55% | 3.17% |
Income Taxes - Components of Ne
Income Taxes - Components of Net Deferred Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Components Of Deferred Tax Assets [Abstract] | ||
Net operating loss carryforwards | $ 94,043 | $ 138,663 |
Research and development credits | 49,965 | 43,879 |
Depreciation and amortization | 9,672 | 7,230 |
Stock-based compensation | 25,983 | 22,807 |
Sales related accruals | 16,404 | 7,137 |
Other accruals | 8,013 | 6,927 |
Gross deferred tax assets | 204,080 | 226,643 |
Right-of-use asset | (2,566) | (2,396) |
In-process research and development | (589) | (589) |
Gross deferred tax liabilities | (3,155) | (2,985) |
Total net deferred tax asset | 200,925 | 223,658 |
Less valuation allowance | $ (200,925) | $ (223,658) |
Income Taxes - Reconciliation_2
Income Taxes - Reconciliation of Unrecognized Tax Benefits (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Reconciliation Of Unrecognized Tax Benefits Excluding Amounts Pertaining To Examined Tax Returns Roll Forward | |||
Balance at beginning of year | $ 11,603 | $ 18,115 | $ 15,682 |
Additions based on tax positions related to current year | 1,749 | 1,206 | 1,276 |
Additions (reductions) for tax positions of prior years | (109) | (7,718) | 1,157 |
Balance at end of year | $ 13,243 | $ 11,603 | $ 18,115 |
Net Income (Loss) Per Share A_3
Net Income (Loss) Per Share Attributable to Coherus - Computation of Basic and Diluted Net Income Per Share Attributable to the Company (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Numerator: | |||
Net income (loss) attributable to Coherus | $ 132,244 | $ 89,833 | $ (209,339) |
Denominator: | |||
Weighted-average common shares outstanding | 71,411,705 | 69,679,916 | 65,034,827 |
Basic net income (loss) per share attributable to Coherus | $ 1.85 | $ 1.29 | $ (3.22) |
Numerator: | |||
Net income (loss) attributable to Coherus | $ 132,244 | $ 89,833 | $ (209,339) |
Numerator for diluted (loss) net income per share attributable to Coherus | $ 135,551 | $ 89,833 | $ (209,339) |
Denominator: | |||
Denominator for basic net income (loss) per share attributable to Coherus | 71,411,705 | 69,679,916 | 65,034,827 |
Stock options, including purchases from contributions to ESPP | 3,455,646 | 3,491,272 | |
Restricted stock units | 167,597 | 14,755 | |
Denominator for diluted net income (loss) per share attributable to Coherus | 83,491,898 | 73,185,943 | 65,034,827 |
Diluted net income (loss) per share attributable to Coherus | $ 1.62 | $ 1.23 | $ (3.22) |
2026 Convertible Notes | |||
Numerator: | |||
Add interest expense on convertible notes, net of tax | $ 3,307 | ||
Denominator: | |||
Shares issuable upon conversion of convertible notes | 8,456,950 |
Net Income (Loss) Per Share A_4
Net Income (Loss) Per Share Attributable to Coherus - Outstanding Dilutive Potential Shares Excluded from Calculation of Diluted Net Income Per Share Attributable to Coherus (Details) - shares | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Antidilutive securities excluded from computation of EPS | |||
Antidilutive securities excluded from the calculation of diluted net income (loss) per share attributable to Coherus | 14,002,963 | 14,908,410 | 19,261,805 |
Stock Options, Including Purchases from Contributions to ESPP | |||
Antidilutive securities excluded from computation of EPS | |||
Antidilutive securities excluded from the calculation of diluted net income (loss) per share attributable to Coherus | 9,521,403 | 10,412,471 | 14,743,547 |
Restricted stock units | |||
Antidilutive securities excluded from computation of EPS | |||
Antidilutive securities excluded from the calculation of diluted net income (loss) per share attributable to Coherus | 7,689 | 22,068 | 44,387 |
Shares issuable upon conversion of 2022 Convertible Notes | |||
Antidilutive securities excluded from computation of EPS | |||
Antidilutive securities excluded from the calculation of diluted net income (loss) per share attributable to Coherus | 4,473,871 | 4,473,871 | 4,473,871 |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | ||||
Sep. 30, 2018 | Feb. 28, 2014 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Feb. 29, 2016 | |
Related Party Transaction | ||||||
Research and development expense | $ 142,759 | $ 94,188 | $ 110,239 | |||
Payments to acquire securities of non-controlling interest in subsidiary | 300 | |||||
InteKrin Therapeutics Inc | RUSSIA | ||||||
Related Party Transaction | ||||||
Payments to acquire securities of non-controlling interest in subsidiary | $ 700 | |||||
Percentage of securities acquired | 17.50% | |||||
InteKrin Therapeutics Inc | Mr. Lanfear | RUSSIA | ||||||
Related Party Transaction | ||||||
Consideration received for shares | $ 400 | |||||
InteKrin Russia | ||||||
Related Party Transaction | ||||||
Business combination consideration transferred | $ 5,000 | |||||
Medpace Inc | ||||||
Related Party Transaction | ||||||
Research and development expense | $ 1,500 | |||||
Affiliated Entity | ||||||
Related Party Transaction | ||||||
Aggregate principal amount | $ 25,000 | |||||
Chief Executive Officer | InteKrin Russia | InteKrin Therapeutics Inc | Mr. Lanfear | ||||||
Related Party Transaction | ||||||
Related party transaction ownership percentage | 10.00% |
Subsequent Event - Additional I
Subsequent Event - Additional Information (Details) $ / shares in Units, $ in Millions | Feb. 01, 2021USD ($)item$ / sharesshares | Dec. 31, 2020$ / shares | Dec. 31, 2019$ / shares |
Subsequent Event [Line Items] | |||
Common Stock Par Or Stated Value Per Share | $ / shares | $ 0.0001 | $ 0.0001 | |
Junshi Biosciences | Subsequent Event | |||
Subsequent Event [Line Items] | |||
Collaboration Agreement | $ 150 | ||
Collaboration Agreement, Number Of Undisclosed Preclinical Immuno Oncology Drug Candidates | item | 2 | ||
Collaboration Agreement, Percentage Of Royalty On Net Sales | 20.00% | ||
Collaboration Agreement , Threshold Royalty Payments | $ 380 | ||
Collaboration Agreement , Maximum Payments On Attainment Of Certain Sales Thresholds | 290 | ||
Collaboration Agreement, Option Exercise Fee Per Program | $ 35 | ||
Collaboration Agreement, Percentage Of Royalty On Net Sales For Each Option Program | 18.00% | ||
Collaboration Agreement , Threshold Payments On Achievement Of Various Milestone For Each Option Program | $ 255 | ||
Collaboration Agreement , Maximum Payments On Attainment Of Certain Sales Thresholds For Each Option Program | 170 | ||
Collaboration Agreement, Maximum Payments For Co-development Activities | $ 25 | ||
Share Price | $ / shares | $ 20.0643 | ||
Stock Purchase Agreement, Shares Agreed To Be Issued | shares | 2,491,988 | ||
Stock Purchase Agreement, Shares Agreed To Be Issued, Value | $ 50 |