Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2020 | Oct. 31, 2020 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Sep. 30, 2020 | |
Entity File Number | 001-36721 | |
Entity Registrant Name | Coherus BioSciences, Inc. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 27-3615821 | |
Entity Address, Address Line One | 333 Twin Dolphin Drive | |
Entity Address, Address Line Two | Suite 600 | |
Entity Address, City or Town | Redwood City | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 94065 | |
City Area Code | 650 | |
Local Phone Number | 649-3530 | |
Title of 12(b) Security | Common Stock, $0.0001 par value per share | |
Trading Symbol | CHRS | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 72,048,012 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2020 | |
Document Fiscal Period Focus | Q3 | |
Entity Central Index Key | 0001512762 | |
Amendment Flag | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (unaudited) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 | [1] |
Current assets: | |||
Cash and cash equivalents | $ 292,465 | $ 177,668 | |
Investments in marketable securities | 210,966 | ||
Trade receivables, net | 160,707 | 141,992 | |
Inventory | 35,247 | 9,807 | |
Prepaid manufacturing | 21,928 | 8,578 | |
Other prepaid and other assets | 5,607 | 4,964 | |
Total current assets | 726,920 | 343,009 | |
Property and equipment, net | 10,647 | 5,840 | |
Inventory, non-current | 50,717 | 45,264 | |
Operating lease right-of-use assets | 10,470 | 10,649 | |
Intangible assets | 2,620 | 2,620 | |
Goodwill | 943 | 943 | |
Restricted cash, non-current | 440 | 240 | |
Other assets, non-current | 976 | 362 | |
Total assets | 803,733 | 408,927 | |
Current liabilities: | |||
Accounts payable | 11,990 | 25,985 | |
Accrued rebates, fees and reserve | 75,961 | 51,120 | |
Accrued compensation | 17,412 | 18,410 | |
Accrued liabilities | 23,446 | 17,258 | |
Other current liabilities | 4,623 | 2,196 | |
Total current liabilities | 133,432 | 114,969 | |
Contingent consideration, non-current | 102 | 102 | |
Convertible notes due 2022 | 79,537 | 78,542 | |
Convertible notes due 2022 - related parties | 26,512 | 26,181 | |
Convertible notes due 2026 | 222,718 | ||
Term loan | 74,267 | 73,663 | |
Lease liabilities, non-current | 10,729 | 10,256 | |
Other liabilities, non-current | 705 | ||
Total liabilities | 548,002 | 303,713 | |
Commitments and contingencies (Note 8) | |||
Stockholders' equity: | |||
Common stock | 7 | 7 | |
Additional paid-in capital | 1,028,441 | 1,000,763 | |
Accumulated other comprehensive loss | (255) | (558) | |
Accumulated deficit | (772,462) | (894,998) | |
Total stockholders' equity | 255,731 | 105,214 | |
Total liabilities and stockholders' equity | $ 803,733 | $ 408,927 | |
[1] | The consolidated balance sheet as of December 31, 2019 has been derived from the audited consolidated balance sheet included in the Company ’ s 2019 Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 27, 2020. |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Revenue: | ||||
Net product revenue | $ 113,551 | $ 111,684 | $ 365,405 | $ 232,215 |
Operating expenses: | ||||
Cost of goods sold | 9,000 | 6,447 | 25,994 | 9,273 |
Research and development | 38,851 | 21,568 | 98,131 | 59,240 |
Selling, general and administrative | 31,984 | 31,828 | 101,386 | 100,967 |
Total operating expenses | 79,835 | 59,843 | 225,511 | 169,480 |
Income from operations | 33,716 | 51,841 | 139,894 | 62,735 |
Interest expense (includes related party of $625 and $615 for the three months ended September 30, 2020 and 2019, respectively; and $1,867 and $1,839 for the nine months ended September 30, 2020 and 2019, respectively) | (5,656) | (4,469) | (15,495) | (13,118) |
Other income, net | 56 | 518 | 548 | 1,887 |
Net income before income taxes | 28,116 | 47,890 | 124,947 | 51,504 |
Income tax provision | 183 | 847 | 2,411 | 898 |
Net income | $ 27,933 | $ 47,043 | $ 122,536 | $ 50,606 |
Net income per share: | ||||
Basic | $ 0.39 | $ 0.67 | $ 1.72 | $ 0.73 |
Diluted | $ 0.33 | $ 0.63 | $ 1.52 | $ 0.69 |
Weighted-average number of shares used in computing net income per share: | ||||
Basic | 71,649,350 | 69,877,693 | 71,138,973 | 69,501,835 |
Diluted | 87,470,337 | 78,530,227 | 82,043,469 | 72,872,076 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Operations (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Condensed Consolidated Statements of Operations (unaudited) | ||||
Interest expense from transactions with related party | $ 625 | $ 615 | $ 1,867 | $ 1,839 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Comprehensive Income (unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Condensed Consolidated Statements of Comprehensive Income (unaudited) | ||||
Net income | $ 27,933 | $ 47,043 | $ 122,536 | $ 50,606 |
Other comprehensive income (loss): | ||||
Unrealized gain on available-for-sale securities, net of tax | 6 | 18 | ||
Foreign currency translation adjustments, net of tax | (4) | 59 | 285 | (170) |
Comprehensive income | $ 27,935 | $ 47,102 | $ 122,839 | $ 50,436 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Stockholders' Equity (unaudited) - USD ($) $ in Thousands | 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)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) | 2019 Bonus Payout | Cumulative translation adjustment | Total | |
Beginning Balances at Dec. 31, 2018 | $ 7 | $ 946,515 | $ (136) | $ (282) | $ (984,831) | $ (136) | $ (38,591) | ||||||||||||
Beginning Balances, Shares at Dec. 31, 2018 | 68,302,681 | ||||||||||||||||||
Issuance of common stock upon exercise of stock options | 825 | 825 | |||||||||||||||||
Issuance of common stock upon exercise of stock options, Shares | 143,523 | ||||||||||||||||||
Issuance of common stock upon vesting of restricted stock units (RSUs), Shares | 22,195 | ||||||||||||||||||
Issuance of common stock | $ 1,350 | $ 8,228 | $ 1,350 | $ 8,228 | |||||||||||||||
Issuance of common stock, Shares | 109,168 | 761,130 | |||||||||||||||||
Stock-based compensation expense | 9,813 | 9,813 | |||||||||||||||||
Net income (loss) | (20,004) | (20,004) | |||||||||||||||||
Ending Balances at Mar. 31, 2019 | $ 7 | 966,731 | (93) | (418) | (1,004,835) | (93) | (38,515) | ||||||||||||
Ending Balances, shares at Mar. 31, 2019 | 69,338,697 | ||||||||||||||||||
Beginning Balances at Dec. 31, 2018 | $ 7 | 946,515 | (136) | (282) | (984,831) | (136) | (38,591) | ||||||||||||
Beginning Balances, Shares at Dec. 31, 2018 | 68,302,681 | ||||||||||||||||||
Cumulative translation adjustment | $ (170) | ||||||||||||||||||
Ending Balances at Sep. 30, 2019 | $ 7 | 990,693 | (452) | (934,225) | 56,023 | ||||||||||||||
Ending Balances, shares at Sep. 30, 2019 | 70,091,987 | ||||||||||||||||||
Beginning Balances at Mar. 31, 2019 | $ 7 | 966,731 | (93) | (418) | (1,004,835) | (93) | (38,515) | ||||||||||||
Beginning Balances, Shares at Mar. 31, 2019 | 69,338,697 | ||||||||||||||||||
Issuance of common stock upon exercise of stock options | 674 | 674 | |||||||||||||||||
Issuance of common stock upon exercise of stock options, Shares | 108,374 | ||||||||||||||||||
Issuance of common stock under the employee stock purchase plan ("ESPP") | 1,878 | 1,878 | |||||||||||||||||
Issuance of common stock under the employee stock purchase plan ("ESPP"), Shares | 180,077 | ||||||||||||||||||
Stock-based compensation expense | 8,504 | 8,504 | |||||||||||||||||
Net income (loss) | 23,567 | 23,567 | |||||||||||||||||
Ending Balances at Jun. 30, 2019 | $ 7 | 977,787 | 59 | (511) | (981,268) | $ 59 | (3,985) | ||||||||||||
Ending Balances, shares at Jun. 30, 2019 | 69,627,148 | ||||||||||||||||||
Issuance of common stock upon exercise of stock options | 3,707 | 3,707 | |||||||||||||||||
Issuance of common stock upon exercise of stock options, Shares | 447,269 | ||||||||||||||||||
Issuance of common stock upon vesting of restricted stock units (RSUs), Shares | 17,570 | ||||||||||||||||||
Stock-based compensation expense | 9,199 | 9,199 | |||||||||||||||||
Cumulative translation adjustment | 59 | ||||||||||||||||||
Net income (loss) | 47,043 | 47,043 | |||||||||||||||||
Ending Balances at Sep. 30, 2019 | $ 7 | 990,693 | (452) | (934,225) | $ 56,023 | ||||||||||||||
Ending Balances, shares at Sep. 30, 2019 | 70,091,987 | ||||||||||||||||||
Beginning Balances at Dec. 31, 2019 | $ 7 | 1,000,763 | 608 | (558) | (894,998) | $ 608 | 105,214 | [1] | |||||||||||
Beginning Balances, Shares at Dec. 31, 2019 | 70,366,661 | ||||||||||||||||||
Issuance of common stock upon exercise of stock options | 4,438 | 4,438 | |||||||||||||||||
Issuance of common stock upon exercise of stock options, Shares | 421,850 | ||||||||||||||||||
Issuance of common stock upon vesting of restricted stock units (RSUs), Shares | 10,000 | ||||||||||||||||||
Issuance of common stock | $ 2,378 | $ 2,378 | |||||||||||||||||
Issuance of common stock, Shares | 134,099 | ||||||||||||||||||
Taxes paid related to net share settlement of bonus payout in RSUs | (880) | (880) | |||||||||||||||||
Taxes paid related to net share settlement of bonus payout in RSUs, Shares | (49,616) | ||||||||||||||||||
Stock-based compensation expense | 9,945 | 9,945 | |||||||||||||||||
Net income (loss) | 35,572 | 35,572 | |||||||||||||||||
Ending Balances at Mar. 31, 2020 | $ 7 | 1,016,644 | (319) | 50 | (859,426) | (319) | 157,275 | ||||||||||||
Ending Balances, shares at Mar. 31, 2020 | 70,882,994 | ||||||||||||||||||
Beginning Balances at Dec. 31, 2019 | $ 7 | 1,000,763 | 608 | (558) | (894,998) | 608 | 105,214 | [1] | |||||||||||
Beginning Balances, Shares at Dec. 31, 2019 | 70,366,661 | ||||||||||||||||||
Cumulative translation adjustment | 285 | ||||||||||||||||||
Ending Balances at Sep. 30, 2020 | $ 7 | 1,028,441 | (255) | (772,462) | 255,731 | ||||||||||||||
Ending Balances, shares at Sep. 30, 2020 | 72,024,366 | ||||||||||||||||||
Beginning Balances at Mar. 31, 2020 | $ 7 | 1,016,644 | (319) | 50 | (859,426) | (319) | 157,275 | ||||||||||||
Beginning Balances, Shares at Mar. 31, 2020 | 70,882,994 | ||||||||||||||||||
Issuance of common stock upon exercise of stock options | 3,305 | 3,305 | |||||||||||||||||
Issuance of common stock upon exercise of stock options, Shares | 289,241 | ||||||||||||||||||
Issuance of common stock under the employee stock purchase plan ("ESPP") | 2,557 | 2,557 | |||||||||||||||||
Issuance of common stock under the employee stock purchase plan ("ESPP"), Shares | 180,970 | ||||||||||||||||||
Purchase of capped call options related to convertible notes due 2026 | (18,170) | (18,170) | |||||||||||||||||
Stock-based compensation expense | 9,686 | 9,686 | |||||||||||||||||
Unrealized gain in marketable securities | 12 | 12 | |||||||||||||||||
Net income (loss) | 59,031 | 59,031 | |||||||||||||||||
Ending Balances at Jun. 30, 2020 | $ 7 | 1,014,022 | $ (4) | (257) | (800,395) | $ (4) | 213,377 | ||||||||||||
Ending Balances, shares at Jun. 30, 2020 | 71,353,205 | ||||||||||||||||||
Issuance of common stock upon exercise of stock options | 4,962 | 4,962 | |||||||||||||||||
Issuance of common stock upon exercise of stock options, Shares | 598,577 | ||||||||||||||||||
Issuance of common stock upon vesting of restricted stock units (RSUs), Shares | 72,584 | ||||||||||||||||||
Stock-based compensation expense | 9,457 | 9,457 | |||||||||||||||||
Unrealized gain in marketable securities | 6 | 6 | |||||||||||||||||
Cumulative translation adjustment | (4) | ||||||||||||||||||
Net income (loss) | 27,933 | 27,933 | |||||||||||||||||
Ending Balances at Sep. 30, 2020 | $ 7 | $ 1,028,441 | $ (255) | $ (772,462) | $ 255,731 | ||||||||||||||
Ending Balances, shares at Sep. 30, 2020 | 72,024,366 | ||||||||||||||||||
[1] | The consolidated balance sheet as of December 31, 2019 has been derived from the audited consolidated balance sheet included in the Company ’ s 2019 Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 27, 2020. |
Condensed Consolidated Statem_5
Condensed Consolidated Statements of Cash Flows (unaudited) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
Operating activities | ||
Net income | $ 122,536 | $ 50,606 |
Adjustments to reconcile net income to net cash provided by operating activities: | ||
Depreciation and amortization | 2,048 | 2,204 |
Stock-based compensation expense | 28,287 | 26,319 |
Non-cash accretion of discount on marketable securities | (103) | (142) |
Non-cash interest expense from amortization of debt discount | 2,492 | 1,726 |
Excess and obsolete inventory | 410 | |
Other non-cash adjustments | 422 | (1) |
Non-cash operating lease expense | 1,567 | 1,305 |
Upfront and milestone based license fee payments to Innovent | 7,500 | |
Changes in operating assets and liabilities: | ||
Trade receivables, net | (18,885) | (89,646) |
Inventory | (30,053) | (31,151) |
Prepaid manufacturing | (13,350) | 2,525 |
Other prepaid and current assets | (171) | (653) |
Other assets, non-current | (614) | (500) |
Accounts payable | (13,108) | (1,436) |
Accrued rebates, fees and reserve | 24,841 | 37,121 |
Accrued compensation | 1,380 | 4,162 |
Accrued and other liabilities | 5,521 | 9,416 |
Lease liabilities | 6 | (1,590) |
Other liabilities, non-current | 705 | (30) |
Net cash provided by operating activities | 121,021 | 10,645 |
Investing activities | ||
Purchases of property and equipment | (6,279) | (1,435) |
Proceeds from disposal of property and equipment | 167 | |
Purchases of investments in marketable securities | (273,845) | (20,235) |
Proceeds from maturities of investments in marketable securities | 63,000 | 15,000 |
Upfront and milestone based license fee payments to Innovent | (7,500) | |
Net cash used in investing activities | (224,457) | (6,670) |
Financing activities | ||
Proceeds from common stock offering, net of underwriters discounts, commissions and offering costs | 8,153 | |
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 | 13,014 | 5,184 |
Proceeds from purchase under the employee stock purchase plan | 2,557 | 1,878 |
Taxes paid related to net share settlement of bonus payout in RSUs | (880) | |
Other financing activities | (244) | |
Net cash provided by financing activities | 218,433 | 88,170 |
Effect of exchange rate changes in cash, cash equivalents and restricted cash | (170) | |
Net increase in cash, cash equivalents and restricted cash | 114,997 | 91,975 |
Cash, cash equivalents and restricted cash at beginning of period | 177,908 | 73,191 |
Cash, cash equivalents and restricted cash at end of period | 292,905 | 165,166 |
Supplemental disclosure of cash flow information | ||
Non-cash bonus payment settled in common stock | 1,498 | 1,350 |
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 | $ 1,771 |
Organization and Summary of Sig
Organization and Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2020 | |
Organization and Summary of Significant Accounting Policies | |
Organization and Summary of Significant Accounting Policies | 1. Organization and Summary of Significant Accounting Policies Organization Coherus BioSciences, Inc. (the “Company”, “Coherus”, “we”, our” or “us”) is a commercial-stage biotherapeutics company, focused on the biosimilar 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 biosimilar pipeline comprises of four biosimilar drugs, CHS-1420 (an adalimumab (Humira®) biosimilar), CHS-2020 (an aflibercept (Eylea®) biosimilar), a ranibizumab (Lucentis®) biosimilar in-licensed for U.S. and Canadian commercial rights from Bioeq AG, and a bevacizumab (Avastin®) biosimilar in-licensed for U.S. commercial rights from Innovent Biologics (Suzhou) 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 The accompanying condensed consolidated financial statements include the accounts of Coherus and its wholly-owned subsidiaries as of September 30, 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. The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) for interim financial information and in accordance with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X of the Securities Act of 1933, as amended (the “Securities Act”). Accordingly, they do not include all of the information and notes required by U.S. GAAP for complete financial statements. These unaudited condensed consolidated financial statements include all adjustments, consisting only of normal recurring accruals that the Company believes are necessary to fairly state the financial position and the results of the Company’s operations and cash flows for interim periods in accordance with U.S. GAAP. Interim-period results are not necessarily indicative of results of operations or cash flows for a full year or any subsequent interim period. The accompanying condensed consolidated financial statements should be read in conjunction with the Company’s audited financial statements and notes thereto included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on February 27, 2020. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make judgements, estimates and assumptions that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosures. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances. These estimates form the basis for making judgments about the carrying values of assets and liabilities when these values are not readily apparent from other sources. Accounting estimates and judgements are inherently uncertain and the actual results could differ from these estimates. 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. Additionally, the Company recorded an adjustment during the second quarter of 2020 to decrease accrued payer rebates by $5.8 million primarily related to the first quarter of 2020 based on the revised methodology after such invoice overstatements were corrected. These adjustments increased net product revenue by $0 and $13.3 million for the three and nine months ended September 30, 2020, respectively. These adjustments resulted in an increase in net income per share (basic) of $0 and $0.19 during the three and nine months ended September 30, 2020, respectively and an increase in net income per share (diluted) of $0 and $0.16 during the three and nine months ended September 30, 2020, respectively. Accrued commercial payer rebates of $23.7 million and $14.0 million were recorded in accrued rebates, fees and reserve as of September 30, 2020 and December 31, 2019, respectively, in the condensed consolidated balance sheet. Cash, Cash Equivalents and Restricted Cash The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheets and which, in aggregate, represent the amount reported in the condensed consolidated statements of cash flows (in thousands): September 30, September 30, 2020 2019 Cash and cash equivalents $ 292,465 $ 165,116 Restricted cash — 50 Restricted cash - non-current 440 — Total cash, cash equivalents and restricted cash $ 292,905 $ 165,166 Restricted cash – non-current consists of deposits for letter of credits that the Company has provided to secure its obligations under certain facility and other leases. 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. 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 September 30, 2020. 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 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 | 9 Months Ended |
Sep. 30, 2020 | |
Fair Value Measurements | |
Fair Value Measurements | 2. Fair Value Measurements Financial assets and liabilities are recorded at fair value. The carrying amounts of certain of the Company’s financial instruments, including cash, 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. A financial instrument’s categorization within the valuation hierarchy is based upon the lowest level of input that is significant to the fair value measurement. The Company’s financial instruments consist of Level 1 and Level 2 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. When quoted market prices are not available for the specific security, then the Company estimates the fair value by using quoted prices for identical or similar instruments in markets that are not active and model-based valuation techniques for which all significant inputs are observable in the market or can be corroborated by observable market data for substantially the full term of the assets. Where applicable, these models project future cash flows and discount the future amounts to a present value using market-based observable inputs obtained from various third party data providers, including but not limited to, benchmark yields, interest rate curves, reported trades, broker/dealer quotes and market reference data. Level 2 assets consist of corporate notes and commercial paper. Level 2 inputs for the valuations are limited to quoted prices for similar assets or liabilities in active markets and inputs other than quoted prices that are observable for the asset. 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 between Level 1, Level 2 and Level 3 during the periods presented. Financial assets and liabilities subject to fair value measurements on a recurring basis and the level of inputs used in such measurements were as follows (in thousands): Fair Value Measurements September 30, 2020 Total Level 1 Level 2 Level 3 Financial Assets: Money market funds $ 278,258 $ 278,258 $ — $ — Restricted cash (money market funds) 440 440 — — Corporate notes and Commercial paper 36,993 — 36,993 — U.S. government agency securities 186,971 186,971 — — Total financial assets $ 502,662 $ 465,669 $ 36,993 $ — 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 Cash equivalents, investments in marketable securities, which are classified as available-for-sale securities, and restricted cash, consisted of the following (in thousands): September 30, 2020 Cost Unrealized Gain Unrealized (Loss) Estimated Fair Value Money market funds $ 278,258 $ — $ — $ 278,258 Corporate notes and commercial paper 12,998 — — 12,998 Classified as cash equivalents $ 291,256 $ — $ — $ 291,256 Corporate notes and Commercial paper $ 23,995 $ — $ — $ 23,995 U.S. government agency securities 186,953 18 — 186,971 Classified as investments in marketable securities $ 210,948 $ 18 $ — $ 210,966 Restricted cash (money market funds) $ 440 $ — $ — $ 440 Classified as restricted cash $ 440 $ — $ — $ 440 December 31, 2019 Cost Unrealized Gain Unrealized (Loss) Estimated Fair Value Money market funds $ 155,523 $ — $ — $ 155,523 Classified as cash equivalents $ 155,523 $ — $ — $ 155,523 Restricted cash (money market funds) $ 240 $ — $ — $ 240 Classified as restricted cash $ 240 $ — $ — $ 240 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 September 30, 2020. 8.2% Convertible Notes due 2022 The estimated fair value of the 8.2% Convertible Senior Notes due 2022, which the Company issued in February 2016 (see Note 7) is based on an income approach. The estimated fair value was approximately $112.8 million (par value $100.0 million) as of September 30, 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 7) of $75 million as of September 30, 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 | 9 Months Ended |
Sep. 30, 2020 | |
Inventory | |
Inventory | 3. Inventory Inventory consisted of the following (in thousands): September 30, December 31, 2020 2019 Raw Materials $ 5,388 $ 5,089 Work in process 64,039 43,446 Finished goods 16,537 6,536 Total $ 85,964 $ 55,071 Balance sheet classifications (in thousands): September 30, December 31, 2020 2019 Inventory $ 35,247 $ 9,807 Inventory, non-current 50,717 45,264 Total $ 85,964 $ 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 condensed consolidated balance sheet. As of September 30, 2020 and December 31, 2019, the non-current portion of inventory consisted of raw materials and a portion of work in process. Prepaid manufacturing of $21.9 million and $8.6 million included in current assets on the condensed consolidated balance sheet as of September 30, 2020 and December 31, 2019, respectively, includes prepayments of $13.2 million and $7.2 million as of September 30, 2020 and December 31, 2019, respectively, made 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. |
Balance Sheet Components
Balance Sheet Components | 9 Months Ended |
Sep. 30, 2020 | |
Balance Sheet Components | |
Balance Sheet Components | 4. Balance Sheet Components Property and Equipment, Net Property and equipment, net are as follows (in thousands): September 30, December 31, 2020 2019 Machinery and equipment $ 13,660 $ 12,611 Computer equipment and software 2,256 2,923 Furniture and fixtures 1,255 714 Leasehold improvements 5,670 4,388 Finance lease right of use assets 1,554 — Construction in progress 2,122 1,500 Total property and equipment 26,517 22,136 Accumulated depreciation and amortization (15,870) (16,296) Property and equipment, net $ 10,647 $ 5,840 Depreciation and amortization expense was $0.7 million and $2.0 million for the three and nine months ended September 30, 2020, respectively, and $0.8 million and $2.2 million for the three and nine months ended September 30, 2019, respectively. Accrued Liabilities Accrued liabilities are as follows (in thousands): September 30, December 31, 2020 2019 Accrued clinical and manufacturing $ 13,374 $ 7,106 Accrued other 10,072 10,152 Accrued liabilities $ 23,446 $ 17,258 |
Revenue
Revenue | 9 Months Ended |
Sep. 30, 2020 | |
Revenue | |
Revenue | 5. Revenue The Company initiated U.S. sales of UDENYCA ® Revenue by significant Customer was distributed as follows: Three Months Ended Nine Months Ended September 30, 2020 September 30, 2019 September 30, 2020 September 30, 2019 Percent of Total Percent of Total Percent of Total Percent of Total McKesson 37 % 43 % 38 % 43 % AmeriSource-Bergen Corp 39 % 29 % 38 % 30 % Cardinal 22 % 26 % 22 % 25 % Others 2 % 2 % 2 % 2 % Total revenue 100 % 100 % 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): Nine Months Ended September 30, 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 323,070 80,264 85,664 488,998 Prior period (611) (2,884) (6,268) (9,763) Payments and customer credits issued (332,745) (58,102) (74,106) (464,953) Balance at September 30, 2020 $ 24,873 $ 46,772 $ 29,784 $ 101,429 Nine Months Ended September 30, 2019 Chargebacks Other Fees, and Discounts Co-pay for Prompt Assistance Payment Rebates and Returns Total Balance at December 31, 2018 $ — $ — $ — $ — Provision related to current period sales 138,082 22,748 45,176 206,006 Payments and customer credits issued (107,719) (4,745) (25,447) (137,911) Balance at September 30, 2019 $ 30,363 $ 18,003 $ 19,729 $ 68,095 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 condensed consolidated balance sheets. |
License Agreements
License Agreements | 9 Months Ended |
Sep. 30, 2020 | |
License Agreements | |
License Agreements | 6. 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 “Bioeq Licensed Products”). Under this agreement, Bioeq granted to the Company an exclusive, royalty-bearing license to commercialize the Bioeq Licensed Products in the field of ophthalmology (and any other approved labelled indication) in the United States. Bioeq will supply to the Company the Bioeq Licensed Products in accordance with terms and conditions specified in the agreement and a manufacturing and supply agreement to be executed by the parties in accordance therewith. The agreement’s initial term continues in effect for ten years after the first commercial sale of a Bioeq Licensed Product in the United States, and thereafter renews for an unlimited period of time unless otherwise terminated in accordance with its terms. Under the agreement, Bioeq must use commercially reasonable efforts to develop and obtain regulatory approval of the Bioeq Licensed Products in the United States in accordance with a development and manufacturing plan, and the Company must use commercially reasonable efforts to commercialize the Bioeq Licensed Products in accordance with a commercialization plan. Additionally, the Company must commit certain pre-launch and post-launch resources to the commercialization of the Bioeq Licensed Products for a limited time as specified in the agreement. The Company accounted for the licensing transaction as an asset acquisition under the relevant accounting rules. The Company recorded an upfront and a milestone payment aggregating to €10.0 million ($11.1 million) as research and development expense in the fourth quarter of 2019. The Company is obligated to pay Bioeq an aggregate of up to €25.0 million in additional milestone payments in connection with the achievement of certain development and regulatory milestones with respect to the Bioeq Licensed Products in the United States. The Company will share a percentage of gross profits on sales of Bioeq Licensed Products in the United States with Bioeq in the low to mid fifty percent range. The additional milestone payments and royalties are contingent upon future events and, therefore, will be recorded when it is probable that a milestone will be achieved or when royalties are due. As of September 30, 2020 and December 31, 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 $2.5 million and $7.5 million during the three and nine months ended September 30, 2020, respectively, related to an upfront payment and a milestone payment for the bevacizumab Licensed Product. As of September 30, 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. |
Convertible Notes and Term Loan
Convertible Notes and Term Loan | 9 Months Ended |
Sep. 30, 2020 | |
Convertible Notes and Term Loan | |
Convertible Notes and Term Loan | 7. Convertible Notes and Term Loan 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 September 30, 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 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 initial purchasers or their respective affiliates and/or other financial institutions (the “option counterparties”). The capped call transactions are generally expected to reduce the potential dilution upon conversion of the 2026 Convertible Notes in the event that the market price per share of the Company’s common stock, as measured under the terms of the capped call transactions, is greater than the strike price of the capped call transactions, which initially corresponds to the conversion price of the 2026 Convertible Notes, and is subject to anti-dilution adjustments generally similar to those applicable to the conversion rate of the 2026 Convertible Notes. The cap price of the capped call transactions will initially be $25.9263 per share, which represents a premium of approximately 75.0% over the last reported sale price of the Company’s common stock of $14.815 per share on April 14, 2020, and is subject to certain adjustments under the terms of the capped call transactions. The 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 condensed 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): September 30, 2020 Principal amount of the 2026 Convertible Notes $ 230,000 Unamortized debt discount and debt issuance costs (7,282) Total 2026 Convertible Notes $ 222,718 If the 2026 Convertible Notes were to be converted on September 30, 2020, the holders of the 2026 Convertible Notes would receive common shares with an aggregate value of $219 million based on the Company’s closing stock price of $18.34 as of September 30, 2020. The following table presents the components of interest expense related to 2026 Convertible Notes (in thousands): Three Months Ended Nine Months Ended September 30, September 30, 2020 2020 Stated coupon interest $ 863 $ 1,572 Accretion of debt discount and debt issuance costs 309 562 Total interest expense $ 1,172 $ 2,134 The remaining unamortized debt discount and debt offering costs related to the Company’s 2026 Convertible Notes of approximately $7.3 million as of September 30, 2020, will be amortized using the effective interest rate over the remaining term of the 2026 Convertible Notes of 5.5 years. The annual effective interest rate is 2.11% for the 2026 Convertible Notes. Future payments on the 2026 Convertible Notes as of September 30, 2020 are as follows (in thousands): Year ending December 31, Remainder of 2020 $ 1,706 2021 3,450 2022 3,450 2023 3,450 2024 3,450 2025 and beyond 235,175 Total minimum payments 250,681 Less amount representing interest (20,681) 2026 Convertible Notes, principal amount 230,000 Less debt discount and debt issuance costs on 2026 Convertible Notes (7,282) Net carrying amount of 2026 Convertible Notes $ 222,718 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”). 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. 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 with effect from 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 negative covenants and events of default (as defined in the Note Purchase Agreement (as defined below)), the occurrence of which could result in the acceleration of all amounts due under the 2022 Convertible Note. As of September 30, 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 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 (in thousands): September 30, December 31, 2020 2019 Principal amount of the 2022 Convertible Notes $ 81,750 $ 81,750 Unamortized debt discount and debt issuance costs (2,213) (3,208) 2022 Convertible Notes $ 79,537 $ 78,542 Principal amount of the 2022 Convertible Notes - related parties $ 27,250 $ 27,250 Unamortized debt discount and debt issuance costs - related parties (738) (1,069) 2022 Convertible Notes - related parties $ 26,512 $ 26,181 Total 2022 Convertible Notes $ 106,049 $ 104,723 If the 2022 Convertible Notes were to be converted on September 30, 2020, the holders of the 2022 Convertible Notes would receive common shares with an aggregate value of $82.1 million based on the Company’s closing stock price of $18.34. The following table presents the components of interest expense (in thousands): Three Months Ended Nine Months Ended September 30, September 30, 2020 2019 2020 2019 Stated coupon interest $ 1,538 $ 1,538 $ 4,614 $ 4,613 Accretion of debt discount and debt issuance costs 340 309 996 906 Interest expense $ 1,878 $ 1,847 $ 5,610 $ 5,519 Stated coupon interest - related parties $ 512 $ 512 $ 1,536 $ 1,537 Accretion of debt discount and debt issuance costs - related parties 113 103 331 302 Interest expense - related parties $ 625 $ 615 $ 1,867 $ 1,839 Total interest expense $ 2,503 $ 2,462 $ 7,477 $ 7,358 The remaining unamortized debt discount and debt offering costs related to the Company’s 2022 Convertible Notes of approximately $3.0 million as of September 30, 2020, will be amortized using the effective interest rate over the remaining term of the 2022 Convertible Notes of 1.5 years. The annual effective interest rate is 9.48% for the 2022 Convertible Notes. Future payments on the 2022 Convertible Notes as of September 30, 2020 are as follows (in thousands): Year ending December 31, Remainder of 2020 $ 2,050 2021 8,200 2022 111,050 Total minimum payments 121,300 Less amount representing interest (12,300) 2022 Convertible Notes, principal amount 109,000 Less debt discount and debt issuance costs on 2022 Convertible Notes (2,951) Net carrying amount of 2022 Convertible Notes $ 106,049 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 ® 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 ® 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 ® 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): September 30, December 31, 2020 2019 Principal amount of the Term Loan $ 75,000 $ 75,000 Unamortized debt discount and debt issuance costs (733) (1,337) Term Loan $ 74,267 $ 73,663 The following table presents the components of interest expense (in thousands): Three Months Ended Nine Months Ended September 30, September 30, 2020 2019 2020 2019 Stated coupon interest $ 1,773 $ 1,821 $ 5,280 $ 5,242 Accretion of debt discount and debt issuance costs 208 186 604 518 Interest expense $ 1,981 $ 2,007 $ 5,884 $ 5,760 The remaining unamortized debt discount and debt offering costs related to the Term Loan of approximately $0.7 million as of September 30, 2020, will be amortized using the effective rate over the remaining term of the Term Loan of 4.25 years. Future payments on the Term Loan as of September 30, 2020 are as follows (in thousands): Year ending December 31, Remainder of 2020 $ 1,773 2021 7,034 2022 7,034 2023 39,187 2024 36,072 2025 11,348 Total minimum payments 102,448 Less amount representing interest (24,448) Term Loan, gross 78,000 Less debt discount and debt issuance costs on Term Loan (3,733) Net carrying amount of Term Loan $ 74,267 |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2020 | |
Commitments and Contingencies. | |
Commitments and Contingencies | 8. 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 ® Years ending December 31, Remainder of 2020 $ 8,813 2021 38,195 2022 9,573 2023 3,386 Total obligations $ 59,967 The Company enters into contracts in the normal course of business with contract research organizations for preclinical studies and clinical trials and contract manufacturing organizations for the manufacture of clinical trial materials. The contracts are cancellable, with varying provisions regarding termination. If a contract with a specific vendor were to be terminated, the Company would 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 | 9 Months Ended |
Sep. 30, 2020 | |
Leases | |
Leases | 9. Leases 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 extend 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 terminate 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 extend 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 41 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): September 30, December 31, Assets Balance Sheet Classification 2020 2019 Operating lease Operating lease right-of-use assets $ 10,470 $ 10,649 Finance lease Property and equipment, net 1,554 — Total leased assets $ 12,024 $ 10,649 September 30, December 31, Liabilities Balance Sheet Classification 2020 2019 Operating lease liabilities, current Other current liabilities $ 2,510 $ 2,196 Operating lease liabilities, non-current Lease liabilities, non-current 9,743 10,256 Total operating lease liabilities $ 12,253 $ 12,452 Finance lease liabilities, current Other current liabilities $ 541 $ — Finance lease liabilities, non-current Lease liabilities, non-current 986 — Total finance lease liabilities $ 1,527 $ 0 Operating lease costs were $0.8 million and $0.6 million for the three months ended September 30, 2020 and 2019, respectively, and $2.4 million and $1.7 million for the nine months ended September 30, 2020 and 2019, respectively. Cash paid for amounts included in the measurement of the operating lease liabilities for the three months ended September 30, 2020 and 2019 was $0.8 million and $0.7 million, respectively, and $2.4 million and $2.0 million for the nine months ended September 30, 2020 and 2019, respectively, and was included in net cash used in operating activities in the condensed 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 three and nine months ended September 30, 2020 and 2019. As of September 30, 2020, the maturities of the operating and finance lease liabilities were as follows (in thousands): Years ending December 31, Operating leases Finance leases Remainder of 2020 $ 852 $ 156 2021 3,425 610 2022 3,293 610 2023 3,438 271 2024 2,888 — 2025 and beyond 700 — Total lease payments 14,596 1,647 Less imputed interest (2,343) (120) Operating lease liabilities $ 12,253 $ 1,527 As of September 30, 2020 and December 31, 2019, the weighted average remaining lease term for operating leases was 4.3 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 September 30, 2020 and December 31, 2019, respectively. The weighted average remaining lease term for finance leases was 2.7 years as of September 30, 2020. The weighted average discount rate used to determine the finance lease liabilities was 5.8% as of September 30, 2020. |
Common Stock and Stock-Based Co
Common Stock and Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2020 | |
Common Stock and Stock-Based Compensation | |
Common Stock and Stock-Based Compensation | 10. Common Stock and Stock-Based Compensation Common Stock Offerings 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. In the first quarter of 2019, the Company sold 761,130 shares of common stock at a weighted average price of $11.17 per share through its ATM Offering Program and received total gross proceeds of $8.5 million. After deducting commission and offering expenses of $0.3 million, the net proceeds were $8.2 million. Following such sales in the first quarter of 2019, the ATM Offering Program terminated as all shares authorized thereunder had been sold. Stock-Based Compensation The stock-based compensation expense recorded related to options and restricted stock units granted to employees and nonemployees were as follows (in thousands): Three Months Ended Nine Months Ended September 30, September 30, 2020 2019 2020 2019 Cost of goods sold (1) $ 175 $ 27 $ 396 $ 70 Research and development 3,231 3,805 10,315 10,427 Selling, general and administrative 5,902 4,958 17,576 15,822 $ 9,308 $ 8,790 $ 28,287 $ 26,319 Capitalized stock-based compensation expense into inventory $ 324 $ 435 $ 1,196 $ 1,267 (1) Stock-based compensation capitalized into inventory is recognized as cost of goods sold when the related product is sold. |
Net Income Per Share
Net Income Per Share | 9 Months Ended |
Sep. 30, 2020 | |
Net Income Per Share | |
Net Income Per Share | 11. Net Income Per Share Basic net income per share is calculated by dividing the net income by the weighted-average number of shares of common stock outstanding for the period, without consideration for potential dilutive common shares. Diluted net income per share is computed by dividing the net income by the weighted average number of common shares outstanding for the period plus any diluted potential common shares outstanding for the period determined using the treasury stock method for options, RSUs and ESPP and using the if-converted method for the convertible notes. The following table sets forth the computation of the basic and diluted net income per share (in thousands, except share and per share data): Three Months Ended Nine Months Ended September 30, September 30, 2020 2019 2020 2019 Basic net income per share Numerator: Net income $ 27,933 $ 47,043 $ 122,536 $ 50,606 Denominator: Weighted-average common shares outstanding 71,649,350 69,877,693 71,138,973 69,501,835 Basic net income per share $ 0.39 $ 0.67 $ 1.72 $ 0.73 Diluted net income per share Numerator: Net income $ 27,933 $ 47,043 $ 122,536 $ 50,606 Add interest expense on 2026 convertible notes, net of tax 1,172 2,462 2,134 — Numerator for diluted net income per share $ 29,105 $ 49,505 $ 124,670 $ 50,606 Denominator: Denominator for basic net income per share 71,649,350 69,877,693 71,138,973 69,501,835 Add effect of potential dilutive securities: Stock options, including purchases from contributions to ESPP 3,641,721 4,165,666 3,505,479 3,353,962 Restricted stock units 237,114 12,997 143,146 16,279 Shares issuable upon conversion of 2026 Convertible Notes 11,942,152 4,473,871 7,255,871 — Denominator for diluted net income per share 87,470,337 78,530,227 82,043,469 72,872,076 Diluted net income per share $ 0.33 $ 0.63 $ 1.52 $ 0.69 The following outstanding dilutive potential shares were excluded from the calculation of diluted net income per share due to their anti-dilutive effect: Three Months Ended Nine Months Ended September 30, September 30, 2020 2019 2020 2019 Stock options, including purchases from contributions to ESPP 9,397,713 6,465,093 9,269,082 10,284,369 Restricted stock units — 10,750 7,217 3,623 Shares issuable upon conversion of 2022 Convertible Notes 4,473,871 — 4,473,871 4,473,871 Total 13,871,584 6,475,843 13,750,170 14,761,863 |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2020 | |
Income Taxes | |
Income Taxes | 12. Income Taxes The Company recorded income tax provision of $0.2 million and $0.8 million for the three months ended September 30, 2020 and 2019, respectively, and $2.4 million and $0.9 million for the nine months ended September 30, 2020 and 2019, respectively, which comprised of state taxes in jurisdictions outside of California for which the Company has a limited operating history. Income tax provision during interim periods is based on applying an estimated annual effective income tax rate to year-to-date income, plus any significant unusual or infrequently occurring items, which are recorded in the interim period in accordance with ASC 740-270. The income tax provision differs from the U.S. federal statutory rate of 21% primarily due to effect of change in the valuation allowance against the Company’s federal deferred tax assets, which reduced the Company’s net tax expense. The Company maintains a full valuation allowance against its net deferred tax assets due to the Company’s history of losses. Coronavirus Aid, Relief and Economic Security Act In March 2020, the U.S. government enacted the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”), which includes modifications to the limitation on business interest expense deduction and net operating loss provisions and provides a payment delay of employer payroll taxes during 2020 after the date of enactment. The Company does not expect the CARES Act to have a material impact on the Company’s financial statements. |
Related Party Transactions
Related Party Transactions | 9 Months Ended |
Sep. 30, 2020 | |
Related Party Transactions | |
Related Party Transactions | 13. Related Party Transactions Convertible Notes 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 7 for related party disclosure). |
Organization and Summary of S_2
Organization and Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2020 | |
Organization and Summary of Significant Accounting Policies | |
Organization and Basis of Presentation | Organization Coherus BioSciences, Inc. (the “Company”, “Coherus”, “we”, our” or “us”) is a commercial-stage biotherapeutics company, focused on the biosimilar 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 biosimilar pipeline comprises of four biosimilar drugs, CHS-1420 (an adalimumab (Humira®) biosimilar), CHS-2020 (an aflibercept (Eylea®) biosimilar), a ranibizumab (Lucentis®) biosimilar in-licensed for U.S. and Canadian commercial rights from Bioeq AG, and a bevacizumab (Avastin®) biosimilar in-licensed for U.S. commercial rights from Innovent Biologics (Suzhou) 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 The accompanying condensed consolidated financial statements include the accounts of Coherus and its wholly-owned subsidiaries as of September 30, 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. The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) for interim financial information and in accordance with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X of the Securities Act of 1933, as amended (the “Securities Act”). Accordingly, they do not include all of the information and notes required by U.S. GAAP for complete financial statements. These unaudited condensed consolidated financial statements include all adjustments, consisting only of normal recurring accruals that the Company believes are necessary to fairly state the financial position and the results of the Company’s operations and cash flows for interim periods in accordance with U.S. GAAP. Interim-period results are not necessarily indicative of results of operations or cash flows for a full year or any subsequent interim period. The accompanying condensed consolidated financial statements should be read in conjunction with the Company’s audited financial statements and notes thereto included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on February 27, 2020. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make judgements, estimates and assumptions that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosures. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances. These estimates form the basis for making judgments about the carrying values of assets and liabilities when these values are not readily apparent from other sources. Accounting estimates and judgements are inherently uncertain and the actual results could differ from these estimates. 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. Additionally, the Company recorded an adjustment during the second quarter of 2020 to decrease accrued payer rebates by $5.8 million primarily related to the first quarter of 2020 based on the revised methodology after such invoice overstatements were corrected. These adjustments increased net product revenue by $0 and $13.3 million for the three and nine months ended September 30, 2020, respectively. These adjustments resulted in an increase in net income per share (basic) of $0 and $0.19 during the three and nine months ended September 30, 2020, respectively and an increase in net income per share (diluted) of $0 and $0.16 during the three and nine months ended September 30, 2020, respectively. Accrued commercial payer rebates of $23.7 million and $14.0 million were recorded in accrued rebates, fees and reserve as of September 30, 2020 and December 31, 2019, respectively, in the condensed consolidated balance sheet. |
Cash, Cash Equivalents and Restricted Cash | Cash, Cash Equivalents and Restricted Cash The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheets and which, in aggregate, represent the amount reported in the condensed consolidated statements of cash flows (in thousands): September 30, September 30, 2020 2019 Cash and cash equivalents $ 292,465 $ 165,116 Restricted cash — 50 Restricted cash - non-current 440 — Total cash, cash equivalents and restricted cash $ 292,905 $ 165,166 Restricted cash – non-current consists of deposits for letter of credits that the Company has provided to secure its obligations under certain facility and other leases. |
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. |
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 September 30, 2020. |
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 Company has reviewed other recent accounting pronouncements and concluded they are either not applicable to the business or that no material effect is expected on the consolidated financial statements as a result of future adoption. |
Organization and Summary of S_3
Organization and Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Organization and Summary of Significant Accounting Policies | |
Schedule of Reconciliation of Cash, Cash Equivalents and Restricted Cash | The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheets and which, in aggregate, represent the amount reported in the condensed consolidated statements of cash flows (in thousands): September 30, September 30, 2020 2019 Cash and cash equivalents $ 292,465 $ 165,116 Restricted cash — 50 Restricted cash - non-current 440 — Total cash, cash equivalents and restricted cash $ 292,905 $ 165,166 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 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 were as follows (in thousands): Fair Value Measurements September 30, 2020 Total Level 1 Level 2 Level 3 Financial Assets: Money market funds $ 278,258 $ 278,258 $ — $ — Restricted cash (money market funds) 440 440 — — Corporate notes and Commercial paper 36,993 — 36,993 — U.S. government agency securities 186,971 186,971 — — Total financial assets $ 502,662 $ 465,669 $ 36,993 $ — 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 |
Schedule of Cash equivalents, investments in marketable securities, which are classified as available-for-sale securities, and restricted cash | Cash equivalents, investments in marketable securities, which are classified as available-for-sale securities, and restricted cash, consisted of the following (in thousands): September 30, 2020 Cost Unrealized Gain Unrealized (Loss) Estimated Fair Value Money market funds $ 278,258 $ — $ — $ 278,258 Corporate notes and commercial paper 12,998 — — 12,998 Classified as cash equivalents $ 291,256 $ — $ — $ 291,256 Corporate notes and Commercial paper $ 23,995 $ — $ — $ 23,995 U.S. government agency securities 186,953 18 — 186,971 Classified as investments in marketable securities $ 210,948 $ 18 $ — $ 210,966 Restricted cash (money market funds) $ 440 $ — $ — $ 440 Classified as restricted cash $ 440 $ — $ — $ 440 December 31, 2019 Cost Unrealized Gain Unrealized (Loss) Estimated Fair Value Money market funds $ 155,523 $ — $ — $ 155,523 Classified as cash equivalents $ 155,523 $ — $ — $ 155,523 Restricted cash (money market funds) $ 240 $ — $ — $ 240 Classified as restricted cash $ 240 $ — $ — $ 240 |
Inventory (Tables)
Inventory (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Inventory | |
Schedule of Inventory | Inventory consisted of the following (in thousands): September 30, December 31, 2020 2019 Raw Materials $ 5,388 $ 5,089 Work in process 64,039 43,446 Finished goods 16,537 6,536 Total $ 85,964 $ 55,071 |
Schedule of Balance Sheet Classification | Balance sheet classifications (in thousands): September 30, December 31, 2020 2019 Inventory $ 35,247 $ 9,807 Inventory, non-current 50,717 45,264 Total $ 85,964 $ 55,071 |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Basis of Presentation | |
Schedule of Property and Equipment, Net | Property and equipment, net are as follows (in thousands): September 30, December 31, 2020 2019 Machinery and equipment $ 13,660 $ 12,611 Computer equipment and software 2,256 2,923 Furniture and fixtures 1,255 714 Leasehold improvements 5,670 4,388 Finance lease right of use assets 1,554 — Construction in progress 2,122 1,500 Total property and equipment 26,517 22,136 Accumulated depreciation and amortization (15,870) (16,296) Property and equipment, net $ 10,647 $ 5,840 |
Schedule of Accrued Liabilities | Accrued liabilities are as follows (in thousands): September 30, December 31, 2020 2019 Accrued clinical and manufacturing $ 13,374 $ 7,106 Accrued other 10,072 10,152 Accrued liabilities $ 23,446 $ 17,258 |
Revenue (Tables)
Revenue (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Revenue | |
Revenue by Significant Customer | Revenue by significant Customer was distributed as follows: Three Months Ended Nine Months Ended September 30, 2020 September 30, 2019 September 30, 2020 September 30, 2019 Percent of Total Percent of Total Percent of Total Percent of Total McKesson 37 % 43 % 38 % 43 % AmeriSource-Bergen Corp 39 % 29 % 38 % 30 % Cardinal 22 % 26 % 22 % 25 % Others 2 % 2 % 2 % 2 % Total revenue 100 % 100 % 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): Nine Months Ended September 30, 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 323,070 80,264 85,664 488,998 Prior period (611) (2,884) (6,268) (9,763) Payments and customer credits issued (332,745) (58,102) (74,106) (464,953) Balance at September 30, 2020 $ 24,873 $ 46,772 $ 29,784 $ 101,429 Nine Months Ended September 30, 2019 Chargebacks Other Fees, and Discounts Co-pay for Prompt Assistance Payment Rebates and Returns Total Balance at December 31, 2018 $ — $ — $ — $ — Provision related to current period sales 138,082 22,748 45,176 206,006 Payments and customer credits issued (107,719) (4,745) (25,447) (137,911) Balance at September 30, 2019 $ 30,363 $ 18,003 $ 19,729 $ 68,095 |
Convertible Notes and Term Lo_2
Convertible Notes and Term Loan (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Debt Instrument | |
Components of Term Loan | The following table summarizes information about the components of the Term Loan (in thousands): September 30, December 31, 2020 2019 Principal amount of the Term Loan $ 75,000 $ 75,000 Unamortized debt discount and debt issuance costs (733) (1,337) Term Loan $ 74,267 $ 73,663 |
2026 Convertible Notes | |
Debt Instrument | |
Components of Convertible Notes | The following table summarizes information about the components of the 2026 Convertible Notes (in thousands): September 30, 2020 Principal amount of the 2026 Convertible Notes $ 230,000 Unamortized debt discount and debt issuance costs (7,282) Total 2026 Convertible Notes $ 222,718 |
Components of Interest Expense | The following table presents the components of interest expense related to 2026 Convertible Notes (in thousands): Three Months Ended Nine Months Ended September 30, September 30, 2020 2020 Stated coupon interest $ 863 $ 1,572 Accretion of debt discount and debt issuance costs 309 562 Total interest expense $ 1,172 $ 2,134 |
Schedule of Future Payments on Debt | Future payments on the 2026 Convertible Notes as of September 30, 2020 are as follows (in thousands): Year ending December 31, Remainder of 2020 $ 1,706 2021 3,450 2022 3,450 2023 3,450 2024 3,450 2025 and beyond 235,175 Total minimum payments 250,681 Less amount representing interest (20,681) 2026 Convertible Notes, principal amount 230,000 Less debt discount and debt issuance costs on 2026 Convertible Notes (7,282) Net carrying amount of 2026 Convertible Notes $ 222,718 |
2022 Convertible Notes | |
Debt Instrument | |
Components of Convertible Notes | The following table summarizes information about the components of the 2022 Convertible Notes (in thousands): September 30, December 31, 2020 2019 Principal amount of the 2022 Convertible Notes $ 81,750 $ 81,750 Unamortized debt discount and debt issuance costs (2,213) (3,208) 2022 Convertible Notes $ 79,537 $ 78,542 Principal amount of the 2022 Convertible Notes - related parties $ 27,250 $ 27,250 Unamortized debt discount and debt issuance costs - related parties (738) (1,069) 2022 Convertible Notes - related parties $ 26,512 $ 26,181 Total 2022 Convertible Notes $ 106,049 $ 104,723 |
Components of Interest Expense | The following table presents the components of interest expense (in thousands): Three Months Ended Nine Months Ended September 30, September 30, 2020 2019 2020 2019 Stated coupon interest $ 1,538 $ 1,538 $ 4,614 $ 4,613 Accretion of debt discount and debt issuance costs 340 309 996 906 Interest expense $ 1,878 $ 1,847 $ 5,610 $ 5,519 Stated coupon interest - related parties $ 512 $ 512 $ 1,536 $ 1,537 Accretion of debt discount and debt issuance costs - related parties 113 103 331 302 Interest expense - related parties $ 625 $ 615 $ 1,867 $ 1,839 Total interest expense $ 2,503 $ 2,462 $ 7,477 $ 7,358 |
Schedule of Future Payments on Debt | Future payments on the 2022 Convertible Notes as of September 30, 2020 are as follows (in thousands): Year ending December 31, Remainder of 2020 $ 2,050 2021 8,200 2022 111,050 Total minimum payments 121,300 Less amount representing interest (12,300) 2022 Convertible Notes, principal amount 109,000 Less debt discount and debt issuance costs on 2022 Convertible Notes (2,951) Net carrying amount of 2022 Convertible Notes $ 106,049 |
Term Loan | |
Debt Instrument | |
Components of Interest Expense | The following table presents the components of interest expense (in thousands): Three Months Ended Nine Months Ended September 30, September 30, 2020 2019 2020 2019 Stated coupon interest $ 1,773 $ 1,821 $ 5,280 $ 5,242 Accretion of debt discount and debt issuance costs 208 186 604 518 Interest expense $ 1,981 $ 2,007 $ 5,884 $ 5,760 |
Schedule of Future Payments on Debt | Future payments on the Term Loan as of September 30, 2020 are as follows (in thousands): Year ending December 31, Remainder of 2020 $ 1,773 2021 7,034 2022 7,034 2023 39,187 2024 36,072 2025 11,348 Total minimum payments 102,448 Less amount representing interest (24,448) Term Loan, gross 78,000 Less debt discount and debt issuance costs on Term Loan (3,733) Net carrying amount of Term Loan $ 74,267 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Commitments and Contingencies. | |
Schedule of Non-Cancellable Purchase Commitment | Years ending December 31, Remainder of 2020 $ 8,813 2021 38,195 2022 9,573 2023 3,386 Total obligations $ 59,967 |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 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): September 30, December 31, Assets Balance Sheet Classification 2020 2019 Operating lease Operating lease right-of-use assets $ 10,470 $ 10,649 Finance lease Property and equipment, net 1,554 — Total leased assets $ 12,024 $ 10,649 September 30, December 31, Liabilities Balance Sheet Classification 2020 2019 Operating lease liabilities, current Other current liabilities $ 2,510 $ 2,196 Operating lease liabilities, non-current Lease liabilities, non-current 9,743 10,256 Total operating lease liabilities $ 12,253 $ 12,452 Finance lease liabilities, current Other current liabilities $ 541 $ — Finance lease liabilities, non-current Lease liabilities, non-current 986 — Total finance lease liabilities $ 1,527 $ 0 |
Schedule of maturities of the operating and finance lease liabilities | As of September 30, 2020, the maturities of the operating and finance lease liabilities were as follows (in thousands): Years ending December 31, Operating leases Finance leases Remainder of 2020 $ 852 $ 156 2021 3,425 610 2022 3,293 610 2023 3,438 271 2024 2,888 — 2025 and beyond 700 — Total lease payments 14,596 1,647 Less imputed interest (2,343) (120) Operating lease liabilities $ 12,253 $ 1,527 |
Common Stock and Stock-Based _2
Common Stock and Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Employee And Nonemployee Stock Option Restricted Stock Units | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs | |
Schedule of Stock-Based Compensation Expense | The stock-based compensation expense recorded related to options and restricted stock units granted to employees and nonemployees were as follows (in thousands): Three Months Ended Nine Months Ended September 30, September 30, 2020 2019 2020 2019 Cost of goods sold (1) $ 175 $ 27 $ 396 $ 70 Research and development 3,231 3,805 10,315 10,427 Selling, general and administrative 5,902 4,958 17,576 15,822 $ 9,308 $ 8,790 $ 28,287 $ 26,319 Capitalized stock-based compensation expense into inventory $ 324 $ 435 $ 1,196 $ 1,267 |
Net Income Per Share (Tables)
Net Income Per Share (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Net Income Per Share | |
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 per share (in thousands, except share and per share data): Three Months Ended Nine Months Ended September 30, September 30, 2020 2019 2020 2019 Basic net income per share Numerator: Net income $ 27,933 $ 47,043 $ 122,536 $ 50,606 Denominator: Weighted-average common shares outstanding 71,649,350 69,877,693 71,138,973 69,501,835 Basic net income per share $ 0.39 $ 0.67 $ 1.72 $ 0.73 Diluted net income per share Numerator: Net income $ 27,933 $ 47,043 $ 122,536 $ 50,606 Add interest expense on 2026 convertible notes, net of tax 1,172 2,462 2,134 — Numerator for diluted net income per share $ 29,105 $ 49,505 $ 124,670 $ 50,606 Denominator: Denominator for basic net income per share 71,649,350 69,877,693 71,138,973 69,501,835 Add effect of potential dilutive securities: Stock options, including purchases from contributions to ESPP 3,641,721 4,165,666 3,505,479 3,353,962 Restricted stock units 237,114 12,997 143,146 16,279 Shares issuable upon conversion of 2026 Convertible Notes 11,942,152 4,473,871 7,255,871 — Denominator for diluted net income per share 87,470,337 78,530,227 82,043,469 72,872,076 Diluted net income per share $ 0.33 $ 0.63 $ 1.52 $ 0.69 |
Outstanding Dilutive Potential Shares Excluded from Calculation of Diluted Net Income Per Share Attributable to Coherus | The following outstanding dilutive potential shares were excluded from the calculation of diluted net income per share due to their anti-dilutive effect: Three Months Ended Nine Months Ended September 30, September 30, 2020 2019 2020 2019 Stock options, including purchases from contributions to ESPP 9,397,713 6,465,093 9,269,082 10,284,369 Restricted stock units — 10,750 7,217 3,623 Shares issuable upon conversion of 2022 Convertible Notes 4,473,871 — 4,473,871 4,473,871 Total 13,871,584 6,475,843 13,750,170 14,761,863 |
Organization and Summary of S_4
Organization and Summary of Significant Accounting Policies - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||||
Sep. 30, 2020 | Jun. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | |
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||||||
Net income from refund received | $ 27,933 | $ 47,043 | $ 122,536 | $ 50,606 | ||
Basic net income per share | $ 0.39 | $ 0.67 | $ 1.72 | $ 0.73 | ||
Earnings Per Share Diluted | $ 0.33 | $ 0.63 | $ 1.52 | $ 0.69 | ||
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 | |||||
Accrued payer rebates | $ 5,800 | |||||
Increase in net product revenue | $ 0 | $ 13,300 | ||||
Basic net income per share | $ 0 | $ 0.19 | ||||
Earnings Per Share Diluted | $ 0 | $ 0.16 | ||||
Commercial payer invoices erroneously overstated | Accrued rebates, fees and reserve | ||||||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||||||
Accrued payer rebates | $ (23,700) | $ (23,700) | $ (14,000) |
Organization and Summary of S_5
Organization and Summary of Significant Accounting Policies - Reconciliation of Cash, Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Dec. 31, 2018 | |
Organization and Summary of Significant Accounting Policies | |||||
Cash and cash equivalents | $ 292,465 | $ 177,668 | [1] | $ 165,116 | |
Restricted cash | 0 | 50 | |||
Restricted cash, non-current | 440 | 240 | [1] | ||
Total cash, cash equivalents and restricted cash | $ 292,905 | $ 177,908 | $ 165,166 | $ 73,191 | |
[1] | The consolidated balance sheet as of December 31, 2019 has been derived from the audited consolidated balance sheet included in the Company ’ s 2019 Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 27, 2020. |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||||
Sep. 30, 2020USD ($)security | Sep. 30, 2019USD ($) | Sep. 30, 2020USD ($)security | Sep. 30, 2019USD ($) | Dec. 31, 2019USD ($) | Apr. 30, 2020 | Apr. 13, 2020USD ($) | Jan. 07, 2019USD ($) | Feb. 29, 2016USD ($) | |
Fair Value Disclosures [Line Items] | |||||||||
Fair Value, Assets, Level 1 to Level 2 Transfers, Amount | $ 0 | $ 0 | $ 0 | ||||||
Fair Value, Assets, Level 2 to Level 1 Transfers, Amount | 0 | 0 | 0 | ||||||
Fair Value, Liabilities, Level 1 to Level 2 Transfers, Amount | 0 | 0 | 0 | ||||||
Fair Value, Liabilities, Level 2 to Level 1 Transfers, Amount | 0 | 0 | 0 | ||||||
Fair Value, Measurement with Unobservable Inputs Reconciliation, Recurring Basis, Asset, Transfers, Net | 0 | $ 0 | 0 | $ 0 | 0 | ||||
Fair Value, Measurement with Unobservable Inputs Reconciliation, Recurring Basis, Liability, Transfers, Net | $ 0 | 0 | $ 0 | 0 | 0 | ||||
Fiscal Year End Tags [Abstract] | |||||||||
Average maturity of investments in available-for-sale marketable securities | 4 months 21 days | ||||||||
Realized gains or losses on marketable securities | $ 0 | 0 | |||||||
Investments in marketable securities has been in an unrealized loss position for more than one year | security | 0 | 0 | |||||||
Credit losses of marketable securities in continuous loss position | $ 0 | $ 0 | $ 0 | $ 0 | |||||
2026 Convertible Notes | |||||||||
Fair Value Disclosures [Line Items] | |||||||||
Convertible notes, interest rate | 1.50% | ||||||||
Debt instrument fair value | 268,200,000 | 268,200,000 | |||||||
Aggregate principal amount | 230,000,000 | 230,000,000 | |||||||
2022 Convertible Notes | |||||||||
Fair Value Disclosures [Line Items] | |||||||||
Convertible notes, interest rate | 8.20% | ||||||||
Aggregate principal amount | 100,000,000 | 100,000,000 | $ 100,000,000 | ||||||
Term Loan | |||||||||
Fair Value Disclosures [Line Items] | |||||||||
Aggregate principal amount | 75,000,000 | 75,000,000 | $ 75,000,000 | ||||||
Level 3 | 2022 Convertible Notes | |||||||||
Fair Value Disclosures [Line Items] | |||||||||
Debt instrument fair value | $ 112,800,000 | $ 112,800,000 | |||||||
Maximum | |||||||||
Fiscal Year End Tags [Abstract] | |||||||||
Remaining contractual maturities of available-for-sale securities | 1 year | 1 year | |||||||
Maximum | Term Loan | |||||||||
Fair Value Disclosures [Line Items] | |||||||||
Aggregate principal amount | $ 230,000,000 | ||||||||
Lender | |||||||||
Fair Value Disclosures [Line Items] | |||||||||
Aggregate principal amount | $ 75,000,000 | ||||||||
Lender | Term Loan | |||||||||
Fair Value Disclosures [Line Items] | |||||||||
Aggregate principal amount | $ 75,000,000 | $ 75,000,000 | $ 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 | Sep. 30, 2020 | Dec. 31, 2019 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | $ 502,662 | $ 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 | 465,669 | 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 | 36,993 | |
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 | 278,258 | 155,523 |
Money Market Funds | Level 1 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 278,258 | 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 | |
Corporate notes and Commercial paper | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 36,993 | |
Corporate notes and Commercial paper | Level 1 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 0 | |
Corporate notes and Commercial paper | Level 2 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 36,993 | |
Corporate notes and Commercial paper | Level 3 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 0 | |
U.S. government agency securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 186,971 | |
U.S. government agency securities | Level 1 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 186,971 | |
U.S. government agency securities | Level 2 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 0 | |
U.S. government agency securities | Level 3 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | $ 0 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Cash Equivalents, Investments in Marketable Securities Classified as Available-for-Sale Securities and Restricted Cash (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Cash Equivalents | ||
Debt Securities, Available-for-sale [Line Items] | ||
Cost | $ 291,256 | $ 155,523 |
Estimated Fair Value | 291,256 | 155,523 |
Cash Equivalents | Money Market Funds | ||
Debt Securities, Available-for-sale [Line Items] | ||
Cost | 278,258 | 155,523 |
Estimated Fair Value | 278,258 | 155,523 |
Cash Equivalents | Corporate notes and Commercial paper | ||
Debt Securities, Available-for-sale [Line Items] | ||
Cost | 12,998 | |
Estimated Fair Value | 12,998 | |
Investment in Marketable Securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Cost | 210,948 | |
Unrealized Gain | 18 | |
Estimated Fair Value | 210,966 | |
Investment in Marketable Securities | Corporate notes and Commercial paper | ||
Debt Securities, Available-for-sale [Line Items] | ||
Cost | 23,995 | |
Estimated Fair Value | 23,995 | |
Investment in Marketable Securities | U.S. government agency securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Cost | 186,953 | |
Unrealized Gain | 18 | |
Estimated Fair Value | 186,971 | |
Restricted Cash | ||
Debt Securities, Available-for-sale [Line Items] | ||
Cost | 440 | 240 |
Estimated Fair Value | 440 | 240 |
Restricted Cash | Restricted Cash (Money Market Funds) | ||
Debt Securities, Available-for-sale [Line Items] | ||
Cost | 440 | 240 |
Estimated Fair Value | $ 440 | $ 240 |
Inventory - Schedule of Invento
Inventory - Schedule of Inventory (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Inventory | ||
Raw materials | $ 5,388 | $ 5,089 |
Work in process | 64,039 | 43,446 |
Finished goods | 16,537 | 6,536 |
Total | $ 85,964 | $ 55,071 |
Inventory - Schedule of Balance
Inventory - Schedule of Balance Sheet Classification (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 | |
Inventory | |||
Inventory | $ 35,247 | $ 9,807 | [1] |
Inventory, non-current | 50,717 | 45,264 | [1] |
Total | $ 85,964 | $ 55,071 | |
[1] | The consolidated balance sheet as of December 31, 2019 has been derived from the audited consolidated balance sheet included in the Company ’ s 2019 Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 27, 2020. |
Inventory - Additional Informat
Inventory - Additional Information (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 | |
Inventory [Line Items] | |||
Prepayment made for manufacturing services | $ 21,928 | $ 8,578 | [1] |
Contract manufacturing organization (CMO) | |||
Inventory [Line Items] | |||
Prepayment made for manufacturing services | $ 13,200 | $ 7,200 | |
[1] | The consolidated balance sheet as of December 31, 2019 has been derived from the audited consolidated balance sheet included in the Company ’ s 2019 Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 27, 2020. |
Balance Sheet Components - Sche
Balance Sheet Components - Schedule of Property and Equipment, Net (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 | |
Property and Equipment, Net | |||
Total property and equipment | $ 26,517 | $ 22,136 | |
Accumulated depreciation and amortization | (15,870) | (16,296) | |
Property and equipment, net | 10,647 | 5,840 | [1] |
Machinery and Equipment | |||
Property and Equipment, Net | |||
Total property and equipment | 13,660 | 12,611 | |
Computer Equipment and Software | |||
Property and Equipment, Net | |||
Total property and equipment | 2,256 | 2,923 | |
Furniture and Fixtures | |||
Property and Equipment, Net | |||
Total property and equipment | 1,255 | 714 | |
Leasehold Improvements | |||
Property and Equipment, Net | |||
Total property and equipment | 5,670 | 4,388 | |
Finance lease right of use assets | |||
Property and Equipment, Net | |||
Total property and equipment | 1,554 | ||
Construction in Progress | |||
Property and Equipment, Net | |||
Total property and equipment | $ 2,122 | $ 1,500 | |
[1] | The consolidated balance sheet as of December 31, 2019 has been derived from the audited consolidated balance sheet included in the Company ’ s 2019 Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 27, 2020. |
Balance Sheet Components - Addi
Balance Sheet Components - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Balance Sheet Components | ||||
Depreciation and amortization | $ 700 | $ 800 | $ 2,048 | $ 2,204 |
Balance Sheet Components - Sc_2
Balance Sheet Components - Schedule of Accrued Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 | |
Balance Sheet Components | |||
Accrued clinical and manufacturing | $ 13,374 | $ 7,106 | |
Accrued other | 10,072 | 10,152 | |
Accrued liabilities | $ 23,446 | $ 17,258 | [1] |
[1] | The consolidated balance sheet as of December 31, 2019 has been derived from the audited consolidated balance sheet included in the Company ’ s 2019 Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 27, 2020. |
Revenue - Additional Informatio
Revenue - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Revenue | ||||
Net product revenue | $ 113,551 | $ 111,684 | $ 365,405 | $ 232,215 |
Revenue - Revenue by Significan
Revenue - Revenue by Significant Customer (Details) - Net Product Revenue - Customer Concentration Risk | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Concentration Risk | ||||
Percentage of total revenue | 100.00% | 100.00% | 100.00% | 100.00% |
McKesson | ||||
Concentration Risk | ||||
Percentage of total revenue | 37.00% | 43.00% | 38.00% | 43.00% |
AmeriSource-Bergen Corp | ||||
Concentration Risk | ||||
Percentage of total revenue | 39.00% | 29.00% | 38.00% | 30.00% |
Cardinal | ||||
Concentration Risk | ||||
Percentage of total revenue | 22.00% | 26.00% | 22.00% | 25.00% |
Others | ||||
Concentration Risk | ||||
Percentage of total revenue | 2.00% | 2.00% | 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 | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
Accounts Notes And Loans Receivable | ||
Balance at December 31 | $ 87,147 | |
Provision related to sales made in: | ||
Current period | 488,998 | $ 206,006 |
Prior period | (9,763) | |
Payments and customer credits issued | (464,953) | (137,911) |
Balance at September 30 | 101,429 | 68,095 |
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 | 323,070 | 138,082 |
Prior period | (611) | |
Payments and customer credits issued | (332,745) | (107,719) |
Balance at September 30 | 24,873 | 30,363 |
Rebates | ||
Accounts Notes And Loans Receivable | ||
Balance at December 31 | 27,494 | |
Provision related to sales made in: | ||
Current period | 80,264 | 22,748 |
Prior period | (2,884) | |
Payments and customer credits issued | (58,102) | (4,745) |
Balance at September 30 | 46,772 | 18,003 |
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 | 85,664 | 45,176 |
Prior period | (6,268) | |
Payments and customer credits issued | (74,106) | (25,447) |
Balance at September 30 | $ 29,784 | $ 19,729 |
License Agreements (Details)
License Agreements (Details) € in Millions, $ in Millions | Jan. 13, 2020USD ($) | Sep. 30, 2020USD ($) | Dec. 31, 2019EUR (€) | Dec. 31, 2019USD ($) | Sep. 30, 2020EUR (€) | Sep. 30, 2020USD ($) |
Bioeq IP AG | ||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | ||||||
Initial term of agreement | 10 years | 10 years | ||||
Estimated period of performance upfront fee | € | € 25 | |||||
Percentage of gross profits on sales | 50.00% | 50.00% | ||||
Bioeq IP AG | Research and Development Expense. | ||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | ||||||
Upfront and milestone payment | € 10 | $ 11.1 | ||||
Innovent Biologics (Suzhou) Co., Ltd. | Bevacizumab Licensed Product | ||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | ||||||
Upfront and milestone payment | $ 5 | |||||
Innovent Biologics (Suzhou) Co., Ltd. | Option exercise fee | ||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | ||||||
Collaboration Costs | $ 5 | |||||
Innovent Biologics (Suzhou) Co., Ltd. | Technology transfer | ||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | ||||||
Collaboration Costs | 10 | |||||
Innovent Biologics (Suzhou) Co., Ltd. | Maximum | Bevacizumab Licensed Product | ||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | ||||||
Aggregate milestone payments | 40 | |||||
Innovent Biologics (Suzhou) Co., Ltd. | Maximum | Rituximab Licensed Product | ||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | ||||||
Aggregate milestone payments | 40 | |||||
Innovent Biologics (Suzhou) Co., Ltd. | Research and Development Expense. | Bevacizumab Licensed Product | ||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions | ||||||
Upfront and milestone payment | $ 2.5 | $ 7.5 |
Convertible Notes and Term Lo_3
Convertible Notes and Term Loan - Additional Information (Details) | Apr. 14, 2020$ / shares | Jan. 07, 2019USD ($) | Feb. 29, 2016USD ($)$ / sharesshares | Apr. 30, 2020USD ($)$ / sharesshares | Sep. 30, 2020USD ($)item$ / shares | Apr. 13, 2020USD ($) | Dec. 31, 2019USD ($) |
Debt Instrument | |||||||
Proceeds from issuance of Convertible Notes due 2026, net of issuance costs | $ 222,156,000 | ||||||
Percentage of cap price | 75 | ||||||
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 | ||||||
Lender | |||||||
Debt Instrument | |||||||
Aggregate principal amount | 75,000,000 | ||||||
2026 Convertible Notes | |||||||
Debt Instrument | |||||||
Aggregate principal amount | $ 230,000,000 | $ 230,000,000 | |||||
Convertible notes, interest rate | 1.50% | ||||||
Convertible notes, premium percentage | 14.815% | 30.00% | |||||
Number of events in default | 0 | ||||||
Payment for capped call transactions | $ 18,200,000 | ||||||
Common shares at conversion | shares | 51.9224 | ||||||
Principal amount of notes converted into shares | $ 1,000 | ||||||
Debt issuance costs | $ 900,000 | ||||||
Contractual term | 6 years | ||||||
Minimum borrowings for indebtedness defaulters | 25.9263 | ||||||
Convertible notes, converted amount | $ 219,000,000 | ||||||
Closing stock, price per share | $ / shares | $ 14.815 | $ 18.34 | |||||
Number of initial purchasers | item | 1 | ||||||
Unamortized debt discount and debt issuance costs on Convertible Notes | $ 7,282,000 | ||||||
Effective interest rate | 2.11% | ||||||
Debt Instrument Term | 5 years 6 months | ||||||
2022 Convertible Notes | |||||||
Debt Instrument | |||||||
Aggregate principal amount | $ 100,000,000 | $ 100,000,000 | |||||
Convertible notes, interest rate | 8.20% | ||||||
Convertible notes, 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 | ||||||
Debt instrument maturity date | Mar. 31, 2022 | ||||||
Convertible notes, premium percentage | 9.00% | ||||||
Common shares at conversion | shares | 44.7387 | ||||||
Conversion price per common share | $ / shares | $ 22.35 | $ 19.26 | |||||
Principal amount of notes converted into shares | $ 1,000 | ||||||
Percentage of applicable conversion price | 160.00% | ||||||
Convertible trading days | 20 | ||||||
Convertible consecutive trading days | 30 | ||||||
Percentage to pay in cash of the par value of notes | 109.00% | ||||||
Convertible notes, covenant compliance | The 2022 Convertible Notes contain customary negative covenants and events of default (as defined in the Note Purchase Agreement (as defined below)), the occurrence of which could result in the acceleration of all amounts due under the 2022 Convertible Note. As of September 30, 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 | $ 82,100,000 | ||||||
Closing stock, price per share | $ / shares | $ 18.34 | ||||||
Unamortized debt discount and debt issuance costs on Convertible Notes | $ 2,951,000 | ||||||
Effective interest rate | 9.48% | ||||||
Term Loan | |||||||
Debt Instrument | |||||||
Aggregate principal amount | $ 75,000,000 | $ 75,000,000 | |||||
Debt instrument maturity date | Jan. 7, 2025 | ||||||
Unamortized debt discount and debt issuance costs on Convertible Notes | $ 3,733,000 | ||||||
Remaining unamortized debt discount and debt offering costs | $ 733,000 | $ 1,337,000 | |||||
Effective interest rate | 10.47% | ||||||
Debt Instrument Term | 4 years 3 months | ||||||
Term Loan | Lender | |||||||
Debt Instrument | |||||||
Aggregate principal amount | $ 75,000,000 | $ 75,000,000 | |||||
Debt Instrument Term | 6 years | ||||||
Term Loan | Maximum | |||||||
Debt Instrument | |||||||
Aggregate principal amount | $ 230,000,000 |
Convertible Notes and Term Lo_4
Convertible Notes and Term Loan - Components of Convertible Notes (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Apr. 30, 2020 | Dec. 31, 2019 | Feb. 29, 2016 | |
Debt Instrument | |||||
Convertible Notes | $ 79,537 | $ 78,542 | [1] | ||
Convertible Notes - related parties | 26,512 | 26,181 | [1] | ||
2022 Convertible Notes | |||||
Debt Instrument | |||||
Principal amount of the Convertible Notes | 100,000 | $ 100,000 | |||
Unamortized debt discount and debt issuance costs | (2,951) | ||||
Total Convertible Notes | 106,049 | 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 | (738) | (1,069) | |||
Convertible Notes - related parties | 26,512 | 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 | (2,213) | (3,208) | |||
Convertible Notes | 79,537 | $ 78,542 | |||
2026 Convertible Notes | |||||
Debt Instrument | |||||
Principal amount of the Convertible Notes | 230,000 | $ 230,000 | |||
Unamortized debt discount and debt issuance costs | (7,282) | ||||
Total Convertible Notes | $ 222,718 | ||||
[1] | The consolidated balance sheet as of December 31, 2019 has been derived from the audited consolidated balance sheet included in the Company ’ s 2019 Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 27, 2020. |
Convertible Notes and Term Lo_5
Convertible Notes and Term Loan - Components of Interest Expense of Convertible Notes (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Debt Instrument | ||||
Accretion of debt discount and debt issuance costs | $ 2,492 | $ 1,726 | ||
Interest expense | $ 625 | $ 615 | 1,867 | 1,839 |
Total interest expense | 5,656 | 4,469 | 15,495 | 13,118 |
2022 Convertible Notes | ||||
Debt Instrument | ||||
Total interest expense | 2,503 | 2,462 | 7,477 | 7,358 |
2022 Convertible Notes | Related Party Debt | ||||
Debt Instrument | ||||
Stated coupon interest | 512 | 512 | 1,536 | 1,537 |
Accretion of debt discount and debt issuance costs | 113 | 103 | 331 | 302 |
Interest expense | 625 | 615 | 1,867 | 1,839 |
2022 Convertible Notes | Parent Company | ||||
Debt Instrument | ||||
Stated coupon interest | 1,538 | 1,538 | 4,614 | 4,613 |
Accretion of debt discount and debt issuance costs | 340 | 309 | 996 | 906 |
Interest expense | 1,878 | 1,847 | 5,610 | $ 5,519 |
2026 Convertible Notes | ||||
Debt Instrument | ||||
Stated coupon interest | 863 | 1,572 | ||
Accretion of debt discount and debt issuance costs | 309 | 562 | ||
Interest expense | $ 1,172 | $ 2,462 | $ 2,134 |
Convertible Notes and Term Lo_6
Convertible Notes and Term Loan - Schedule of Future Payments on the Convertible Notes (Details) $ in Thousands | Sep. 30, 2020USD ($) |
2022 Convertible Notes | |
Debt Instrument | |
Remainder of 2020 | $ 2,050 |
2021 | 8,200 |
2022 | 111,050 |
Total minimum payments | 121,300 |
Less amount representing interest | (12,300) |
Convertible Notes, principal amount | 109,000 |
Less debt discount and debt issuance costs on Convertible Notes | (2,951) |
Net carrying amount | 106,049 |
2026 Convertible Notes | |
Debt Instrument | |
Remainder of 2020 | 1,706 |
2021 | 3,450 |
2022 | 3,450 |
2023 | 3,450 |
2023 | 3,450 |
2025 and beyond | 235,175 |
Total minimum payments | 250,681 |
Less amount representing interest | (20,681) |
Convertible Notes, principal amount | 230,000 |
Less debt discount and debt issuance costs on Convertible Notes | (7,282) |
Net carrying amount | $ 222,718 |
Convertible Notes and Term Lo_7
Convertible Notes and Term Loan - Term Loan Narrative (Details) - USD ($) $ in Thousands | Apr. 13, 2020 | Jan. 07, 2019 | Sep. 30, 2020 | Dec. 31, 2021 | Dec. 31, 2019 | Jan. 01, 2020 | Feb. 29, 2016 |
Term Loan | |||||||
Debt Instrument | |||||||
Total term of the loan | 4 years 3 months | ||||||
Aggregate principal amount | $ 75,000 | $ 75,000 | |||||
Effective interest rate | 10.47% | ||||||
Net sales | $ 250,000 | ||||||
Debt instrument maturity date | Jan. 7, 2025 | ||||||
Percentage required to pay an additional exit fee on principal amount | 4.00% | ||||||
Consolidated net sales, 2020 | $ 125,000 | ||||||
Consolidated net sales, thereafter | 150,000 | ||||||
Unamortized debt discount and debt issuance costs on Term Loan | $ 3,733 | ||||||
Term Loan | Paid on or Prior to the Three Year Anniversary of Closing Date | |||||||
Debt Instrument | |||||||
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 | ||||||
Prepayment premium percentage | 5.00% | ||||||
Term Loan | Paid after the Three Year but on or Prior to the Four Year Anniversary of Closing Date | |||||||
Debt Instrument | |||||||
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 | ||||||
Prepayment premium percentage | 5.00% | ||||||
Term Loan | Paid after the Four Year but on or Prior to the Five Year Anniversary of Closing Date | |||||||
Debt Instrument | |||||||
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 | ||||||
Prepayment premium percentage | 2.50% | ||||||
Term Loan | Paid Thereafter | |||||||
Debt Instrument | |||||||
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 | ||||||
Prepayment premium percentage | 1.25% | ||||||
Term Loan | Maximum | |||||||
Debt Instrument | |||||||
Aggregate principal amount | $ 230,000 | ||||||
Percentage Of Market Capitalization | 20.00% | ||||||
Term Loan | Maximum | Scenario Forecast | |||||||
Debt Instrument | |||||||
Net sales | $ 375,000 | ||||||
Term Loan | Minimum | |||||||
Debt Instrument | |||||||
Consolidated net sales, 2019 | $ 70,000 | ||||||
Term Loan | LIBOR | |||||||
Debt Instrument | |||||||
Effective interest rate | 7.00% | 6.75% | |||||
Shares issuable upon conversion of 2022 Convertible Notes | |||||||
Debt Instrument | |||||||
Total term of the loan | 1 year 6 months | ||||||
Lender | |||||||
Debt Instrument | |||||||
Aggregate principal amount | $ 75,000 | ||||||
Lender | Term Loan | |||||||
Debt Instrument | |||||||
Total term of the loan | 6 years | ||||||
Aggregate principal amount | $ 75,000 | $ 75,000 | |||||
Payment of closing fee to the lenders in form of origination issue discount | $ 1,100 |
Convertible Notes and Term Lo_8
Convertible Notes and Term Loan - Components of Term Loan (Details) - Term Loan - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Debt Instrument | ||
Principal amount of the Term Loan | $ 75,000 | $ 75,000 |
Unamortized debt discount and debt issuance costs | (733) | (1,337) |
Net carrying amount | $ 74,267 | $ 73,663 |
Convertible Notes and Term Lo_9
Convertible Notes and Term Loan - Components of Interest Expense on Term Loan (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Debt Instrument | ||||
Accretion of debt discount and debt issuance costs | $ 2,492 | $ 1,726 | ||
Term Loan | ||||
Debt Instrument | ||||
Stated coupon interest | $ 1,773 | $ 1,821 | 5,280 | 5,242 |
Accretion of debt discount and debt issuance costs | 208 | 186 | 604 | 518 |
Interest expense | $ 1,981 | $ 2,007 | $ 5,884 | $ 5,760 |
Convertible Notes and Term L_10
Convertible Notes and Term Loan - Schedule of Future Payments on the Term Loan (Details) - Term Loan - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Debt Instrument | ||
Remainder of 2020 | $ 1,773 | |
2021 | 7,034 | |
2022 | 7,034 | |
2023 | 39,187 | |
2024 | 36,072 | |
2025 | 11,348 | |
Total minimum payments | 102,448 | |
Less amount representing interest | (24,448) | |
Term Loan, gross | 78,000 | |
Less debt discount and debt issuance costs on Convertible Notes | (3,733) | |
Net carrying amount | $ 74,267 | $ 73,663 |
Commitments and Contingencies -
Commitments and Contingencies - Schedule of Non-Cancellable Purchase Commitment (Details) $ in Thousands | Sep. 30, 2020USD ($) |
Commitments and Contingencies. | |
Remainder of 2020 | $ 8,813 |
2021 | 38,195 |
2022 | 9,573 |
2023 | 3,386 |
Total obligations | $ 59,967 |
Commitments and Contingencies_2
Commitments and Contingencies - Additional Information (Details) | May 02, 2019 |
Amgen | |
Loss Contingencies | |
Royalty payment term | 5 years |
Leases - Additional Information
Leases - Additional Information (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||
Jul. 31, 2015ft² | Sep. 30, 2020USD ($)ft² | Sep. 30, 2019USD ($) | Sep. 30, 2020USD ($)ft²item | Sep. 30, 2019USD ($) | Dec. 31, 2019 | |
Lessee Lease Description | ||||||
Future minimum lease payments for the undelivered vehicles | $ | $ 1,647 | $ 1,647 | ||||
Cash paid for amounts included in measurement of lease liabilities | $ | $ 800 | $ 700 | $ 2,400 | $ 2,000 | ||
Operating lease weighted average remaining term | 4 years 3 months 18 days | 4 years 3 months 18 days | 4 years 8 months 12 days | |||
Operating lease Weighted average discount rate | 8.10% | 8.10% | 8.20% | |||
Finance lease weighted average remaining term | 2 years 8 months 12 days | 2 years 8 months 12 days | ||||
Finance lease Weighted average discount rate | 5.80% | 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 | 25,017 | ||||
Lease Expiration Date | May 1, 2027 | |||||
Option to extend lease | true | |||||
Term of optional lease renewal | 5 years | 5 years | ||||
Vehicle leases | ||||||
Lessee Lease Description | ||||||
Number of vehicles leased | item | 41 | |||||
Term of leases | 36 months | 36 months |
Leases - Schedule of Balance Sh
Leases - Schedule of Balance Sheet Classification of Lease Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 | |
Assets: | |||
Operating lease right-of-use assets | $ 10,470 | $ 10,649 | [1] |
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 | $ 1,554 | ||
Finance Lease, Right-of-Use Asset, Statement of Financial Position [Extensible List] | us-gaap:PropertyPlantAndEquipmentNet | us-gaap:PropertyPlantAndEquipmentNet | |
Total leased assets | $ 12,024 | $ 10,649 | |
Liabilities: | |||
Operating lease, liability, current | $ 2,510 | $ 2,196 | |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | Other Liabilities Current | Other Liabilities Current | |
Operating lease liability noncurrent | $ 9,743 | $ 10,256 | |
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | Operating lease liability noncurrent | Operating lease liability noncurrent | |
Total operating lease liabilities | $ 12,253 | $ 12,452 | |
Finance lease liabilities, current | $ 541 | ||
Finance Lease, Liability, Current, Statement of Financial Position [Extensible List] | Other Liabilities Current | Other Liabilities Current | |
Finance lease liabilities, non-current | $ 986 | ||
Finance Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | Operating lease liability noncurrent | Operating lease liability noncurrent | |
Total finance lease liabilities | $ 1,527 | $ 0 | |
[1] | The consolidated balance sheet as of December 31, 2019 has been derived from the audited consolidated balance sheet included in the Company ’ s 2019 Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 27, 2020. |
Leases - Operating Lease Costs
Leases - Operating Lease Costs (Details) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Leases | ||||
Operating lease costs | $ 0.8 | $ 0.6 | $ 2.4 | $ 1.7 |
Cash paid for amounts included in measurement of lease liabilities | $ 0.8 | $ 0.7 | $ 2.4 | $ 2 |
Leases - Schedule of Maturities
Leases - Schedule of Maturities of Operating and Finance Lease Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Operating leases | ||
Remainder of 2020 | $ 852 | |
2021 | 3,425 | |
2022 | 3,293 | |
2023 | 3,438 | |
2024 | 2,888 | |
2025 and beyond | 700 | |
Total lease payments | 14,596 | |
Less imputed interest | (2,343) | |
Total operating lease liabilities | 12,253 | $ 12,452 |
Finance leases | ||
Remainder of 2020 | 156 | |
2021 | 610 | |
2022 | 610 | |
2023 | 271 | |
Total lease payments | 1,647 | |
Less imputed interest | (120) | |
Total finance lease liabilities | $ 1,527 | $ 0 |
Common Stock and Stock-Based _3
Common Stock and Stock-Based Compensation - Common Stock Offerings (Details) - At-the-Market Equity Offering Program - Cowen and Company LLC - USD ($) | Oct. 28, 2016 | Mar. 31, 2019 |
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 | |
Offering expense | 300,000 | |
Common stock, net proceeds | $ 8,200,000 |
Common Stock and Stock-Based _4
Common Stock and Stock-Based Compensation - Options and restricted stock units granted to employees and nonemployees (Details) - Employees and Nonemployees Stock Option and Restricted Stock Units - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs | ||||
Stock-based compensation expense | $ 9,308 | $ 8,790 | $ 28,287 | $ 26,319 |
Capitalized stock-based compensation expense into inventory | 324 | 435 | 1,196 | 1,267 |
Cost of Goods Sold | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs | ||||
Stock-based compensation expense | 175 | 27 | 396 | 70 |
Research and Development Expense. | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs | ||||
Stock-based compensation expense | 3,231 | 3,805 | 10,315 | 10,427 |
Selling, General and Administrative Expenses | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs | ||||
Stock-based compensation expense | $ 5,902 | $ 4,958 | $ 17,576 | $ 15,822 |
Net Income Per Share - Computat
Net Income Per Share - Computation of Basic and Diluted Net Income Per Share Attributable to the Company (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Numerator: | ||||
Net income | $ 27,933 | $ 47,043 | $ 122,536 | $ 50,606 |
Denominator: | ||||
Weighted-average common shares outstanding | 71,649,350 | 69,877,693 | 71,138,973 | 69,501,835 |
Basic net income per share | $ 0.39 | $ 0.67 | $ 1.72 | $ 0.73 |
Numerator: | ||||
Net income | $ 27,933 | $ 47,043 | $ 122,536 | $ 50,606 |
Numerator for diluted net income per share attributable to Coherus | $ 29,105 | $ 49,505 | $ 124,670 | $ 50,606 |
Denominator: | ||||
Denominator for basic net income per share | 71,649,350 | 69,877,693 | 71,138,973 | 69,501,835 |
Stock options, including purchases from contributions to ESPP | 3,641,721 | 4,165,666 | 3,505,479 | 3,353,962 |
Restricted stock units | 237,114 | 12,997 | 143,146 | 16,279 |
Denominator for diluted net income per share attributable to Coherus | 87,470,337 | 78,530,227 | 82,043,469 | 72,872,076 |
Diluted net income per share | $ 0.33 | $ 0.63 | $ 1.52 | $ 0.69 |
2026 Convertible Notes | ||||
Numerator: | ||||
Add interest expense on convertible notes, net of tax | $ 1,172 | $ 2,462 | $ 2,134 | |
Denominator: | ||||
Shares issuable upon conversion of convertible notes | 11,942,152 | 4,473,871 | 7,255,871 |
Net Income Per Share - Outstand
Net Income Per Share - Outstanding Dilutive Potential Shares Excluded from Calculation of Diluted Net Income Per Share Attributable to Coherus (Details) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share | ||||
Antidilutive securities excluded from the calculation of diluted net loss per share | 13,871,584 | 6,475,843 | 13,750,170 | 14,761,863 |
Stock Options, Including Purchases from Contributions to ESPP | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share | ||||
Antidilutive securities excluded from the calculation of diluted net loss per share | 9,397,713 | 6,465,093 | 9,269,082 | 10,284,369 |
Restricted Stock Units | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share | ||||
Antidilutive securities excluded from the calculation of diluted net loss per share | 10,750 | 7,217 | 3,623 | |
Shares issuable upon conversion of 2022 Convertible Notes | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share | ||||
Antidilutive securities excluded from the calculation of diluted net loss per share | 4,473,871 | 4,473,871 | 4,473,871 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Income Taxes | ||||
Income tax provision | $ 183 | $ 847 | $ 2,411 | $ 898 |
U.S. federal statutory income tax rate | 21.00% |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Feb. 29, 2016 | |
Related Party Transaction | |||||
Research and development expense | $ 38,851 | $ 21,568 | $ 98,131 | $ 59,240 | |
Affiliated Entity | |||||
Related Party Transaction | |||||
Aggregate principal amount | $ 25,000 |