Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Feb. 24, 2022 | Jun. 30, 2020 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2021 | ||
Document Fiscal Year Focus | 2021 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | EPZM | ||
Security Exchange Name | NASDAQ | ||
Entity File Number | 001-35945 | ||
Title of 12(b) Security | Common stock, $0.0001 par value | ||
Entity Registrant Name | EPIZYME, INC. | ||
Entity Central Index Key | 0001571498 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Large Accelerated Filer | ||
Entity Small Business | false | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
ICFR Auditor Attestation Flag | true | ||
Entity Common Stock Shares Outstanding | 164,482,036 | ||
Entity Public Float | $ 794.6 | ||
Entity Tax Identification Number | 26-1349956 | ||
Entity Address, Address Line One | 400 Technology Square | ||
Entity Address, City or Town | Cambridge | ||
Entity Address, State or Province | MA | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Address, Postal Zip Code | 02139 | ||
City Area Code | 617 | ||
Local Phone Number | 229-5872 | ||
Documents Incorporated by Reference | Portions of the registrant’s definitive proxy statement that the registrant intends to file with the Securities and Exchange Commission pursuant to Regulation 14A in connection with the registrant’s 2021 Annual Meeting of Stockholders are incorporated by reference into Part III of this Annual Report on Form 10-K to the extent stated herein. | ||
Auditor Name | Ernst & Young LLP | ||
Auditor Location | Boston, Massachusetts | ||
Auditor Firm ID | 42 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 98,336 | $ 168,215 |
Marketable securities | 78,454 | 205,391 |
Accounts receivable, net | 6,572 | 3,105 |
Inventory | 3,216 | 10,461 |
Prepaid expenses and other current assets | 19,465 | 17,921 |
Total current assets | 206,043 | 405,093 |
Property and equipment, net | 1,545 | 2,152 |
Operating lease assets | 20,054 | 17,305 |
Intangible assets, net | 42,849 | 47,002 |
Restricted cash and other assets | 18,509 | 2,021 |
Total assets | 289,000 | 473,573 |
Current liabilities: | ||
Accounts payable | 10,265 | 10,163 |
Accrued expenses | 30,777 | 28,572 |
Current portion of operating lease obligation | 4,154 | 4,665 |
Total current liabilities | 45,196 | 43,400 |
Operating lease obligation, net of current portion | 18,497 | 15,409 |
Deferred revenue, net of current portion | 11,950 | 0 |
Related party long-term debt, net of debt discount | 216,461 | 215,670 |
Warrants to purchase common stock | 1,930 | 0 |
Other long-term liabilities | 0 | 21 |
Related party liability related to sale of future royalties | 15,654 | 14,176 |
Commitments and contingencies | ||
Stockholders’ equity: | ||
Preferred stock, $0.0001 par value; 5,000 shares authorized; 338 shares and 350 shares issued and outstanding, respectively (equivalent to 3,378 shares and 3,500 shares of common stock, respectively, upon conversion at a 10:1 ratio) | 36,127 | 36,127 |
Common stock, $0.0001 par value; 150,000 shares and 125,000 shares, respectively, authorized; 101,627 shares and 97,783 shares issued and outstanding, respectively | 11 | 10 |
Additional paid-in capital | 1,183,006 | 1,137,470 |
Accumulated other comprehensive loss | 3 | 3 |
Accumulated deficit | (1,239,835) | (988,713) |
Total stockholders’ equity | (20,688) | 184,897 |
Total liabilities and stockholders’ equity | $ 289,000 | $ 473,573 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2021 | Dec. 31, 2020 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares issued | 338,000 | 338,000 |
Preferred stock, shares outstanding | 338,000 | 338,000 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 150,000,000 | 125,000,000 |
Common stock, shares issued | 106,098,000 | 101,627,000 |
Common stock, shares outstanding | 106,098,000 | 101,627,000 |
Common stock conversion ratio | 10.00% | 10.00% |
Common stock upon conversion | 3,378,000 | 3,378,000 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Revenue: | |||
Total revenue | $ 37,427 | $ 15,762 | $ 23,800 |
Operating expenses: | |||
Cost of revenue | 10,498 | 5,067 | |
Research and development | 130,966 | 110,933 | 132,639 |
Selling, general and administrative | 133,955 | 125,178 | 68,303 |
Total operating expenses | 275,419 | 241,178 | 200,942 |
Operating loss | (237,992) | (225,416) | (177,142) |
Other (expense) income, net: | |||
Interest (expense) income, net | (22,380) | (4,682) | 7,110 |
Other expense, net | (66) | (99) | (13) |
Change in fair value of warrants to purchase common stock | 11,120 | 0 | 0 |
Related party non-cash interest expense related to sale of future royalties | (1,782) | (1,383) | (192) |
Other (expense) income, net | (13,108) | (6,164) | 6,905 |
Loss before income taxes | (251,100) | (231,580) | (170,237) |
Income tax provision | (22) | (114) | (58) |
Net loss | (251,122) | (231,694) | (170,295) |
Other comprehensive (loss) income: | |||
Unrealized gain (loss) on available for sale securities | 0 | (16) | 73 |
Comprehensive loss | (251,122) | (231,710) | (170,222) |
Reconciliation of net loss to net loss attributable to common stockholders: | |||
Net loss | (251,122) | (231,694) | (170,295) |
Accretion of convertible preferred stock | 0 | 0 | (2,940) |
Net loss attributable to common stockholders | $ (251,122) | $ (231,694) | $ (173,235) |
Net loss per share attributable to common stockholders: | |||
Basic | $ (2.45) | $ (2.29) | $ (1.93) |
Diluted | $ (2.45) | $ (2.29) | $ (1.93) |
Weighted-average common shares outstanding used in net loss per share attributable to common stockholders: | |||
Basic | 102,646 | 100,960 | 89,891 |
Diluted | 102,646 | 100,960 | 89,891 |
Product [Member] | |||
Revenue: | |||
Total revenue | $ 30,922 | $ 11,469 | |
Collaboration Revenue [Member] | |||
Revenue: | |||
Total revenue | $ 6,505 | $ 4,293 | $ 23,800 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | |||
Net loss | $ (251,122) | $ (231,694) | $ (170,295) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation and amortization | 5,246 | 3,984 | 840 |
Stock-based compensation | 26,787 | 27,609 | 18,016 |
Amortization of discount (premium) on investments | 970 | (93) | (3,175) |
Amortization of debt discount | 791 | 406 | 37 |
Change in fair value of warrant liability | (11,120) | 0 | 0 |
Loss on disposal of property and equipment | 0 | 19 | 0 |
Non-cash royalty revenue related to sale of future royalties | (31) | ||
Non-cash interest expense associated with the sale of future royalties | 1,782 | 1,383 | 192 |
Deferred income taxes | 0 | 92 | 92 |
Changes in operating assets and liabilities: | |||
Accounts receivable | (3,467) | (538) | 17,500 |
Inventory | (8,224) | (10,461) | 0 |
Prepaid expenses and other current assets | (1,605) | (2,398) | (3,359) |
Accounts payable | 84 | 1,480 | 3,389 |
Accrued expenses | 1,771 | 6,006 | 2,897 |
Deferred revenue | 11,950 | (3,806) | (13,300) |
Operating lease assets | (2,749) | 3,901 | (9,921) |
Operating lease liabilities | 2,577 | (2,085) | 10,043 |
Other assets and liabilities | (493) | (141) | (124) |
Net cash used in operating activities | (226,853) | (206,336) | (147,168) |
CASH FLOWS FROM INVESTING ACTIVITIES: | |||
Purchases of available-for-sale securities | (262,613) | (276,404) | (504,981) |
Maturities of available-for-sale securities | 388,581 | 312,694 | 420,255 |
Purchase of intangible asset | (50,000) | 0 | |
Purchases of property and equipment | (486) | (880) | (594) |
Net cash provided by (used in) investing activities | 125,482 | (14,590) | (85,320) |
CASH FLOWS FROM FINANCING ACTIVITIES: | |||
Proceeds from issuance of common stock, net of commissions | 15,954 | 0 | 122,991 |
Proceeds from issuance of preferred stock, net of commissions | 0 | 0 | 37,432 |
Payment of offering costs | (308) | (79) | (284) |
Proceeds from the issuance of debt | 0 | 195,000 | 25,000 |
Proceeds from the issuance of warrants | 13,050 | ||
Payment of debt issuance costs | 0 | (3,123) | (1,650) |
Proceeds from the issuance of common stock, warrants, and sale of future royalties to RPI, net of offering costs | 0 | 0 | 99,774 |
Proceeds from the issuance of common stock in connection with the exercise of the Put Option, net of financing costs | 0 | 49,915 | 0 |
Payment under capital lease obligation | 0 | 0 | (16) |
Proceeds from stock options exercised | 916 | 6,692 | 2,358 |
Issuance of shares under employee stock purchase plan | 1,880 | 1,254 | 741 |
Net cash provided by financing activities | 31,492 | 249,659 | 286,346 |
Net increase (decrease) in cash, cash equivalents and restricted cash | (69,879) | 28,733 | 53,858 |
Cash, cash equivalents, and restricted cash, beginning of period | 169,724 | 140,991 | 87,133 |
Cash, cash equivalents, and restricted cash, end of period | 99,845 | 169,724 | 140,991 |
SUPPLEMENTAL CASH FLOW INFORMATION: | |||
Unpaid offering costs | 179 | 0 | 78 |
Unpaid debt issuance costs | 0 | 0 | 78 |
Interest paid | 21,748 | 7,461 | 0 |
Property and equipment included in accounts payable or accruals | 0 | 60 | 454 |
Cash paid for income taxes | $ 104 | $ 64 | $ 45 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Put Option | Royalty Pharma [Member] | Series A Convertible Preferred Stock [Member] | Common Stock [Member] | Common Stock [Member]Put Option | Common Stock [Member]Royalty Pharma [Member] | Common Stock [Member]Series A Convertible Preferred Stock [Member] | Preferred Stock [Member] | Preferred Stock [Member]Series A Convertible Preferred Stock [Member] | Additional Paid-In Capital [Member] | Additional Paid-In Capital [Member]Put Option | Additional Paid-In Capital [Member]Royalty Pharma [Member] | Additional Paid-In Capital [Member]Series A Convertible Preferred Stock [Member] | Accumulated Deficit [Member] | Accumulated Other Comprehensive Loss [Member] |
Beginning Balance, Value at Dec. 31, 2018 | $ 233,009 | $ 8 | $ 819,779 | $ (586,724) | $ (54) | |||||||||||
Beginning Balance, Shares at Dec. 31, 2018 | 79,175,380 | |||||||||||||||
Issuance of series A convertible preferred stock, net of commissions and beneficial conversion charge, Value | $ 37,432 | $ 34,492 | $ 2,940 | |||||||||||||
Issuance of Series A Convertible Preferred Stock, net of commissions and beneficial conversion charge, Shares | 350,000 | |||||||||||||||
Accretion of series A convertible preferred stock | 2,940 | $ 2,940 | (2,940) | |||||||||||||
Issuance of common stock, Value | 122,708 | $ 78,705 | $ 1 | $ 1 | 122,707 | $ 78,704 | ||||||||||
Issuance of common stock, Shares | 11,500,000 | 6,666,667 | ||||||||||||||
Issuance of warrant | $ 8,390 | $ 8,390 | ||||||||||||||
Exercise of stock options and vesting of restricted stock units, Value | 2,358 | 2,358 | ||||||||||||||
Exercise of stock options and vesting of restricted stock units, Shares | 356,538 | |||||||||||||||
Stock-based compensation | 17,875 | 17,875 | ||||||||||||||
Stock in lieu of board fees | 141 | 141 | ||||||||||||||
Stock in lieu of board fees, Shares | 12,156 | |||||||||||||||
Issuance of shares under employee stock purchase plan, Value | 741 | 741 | ||||||||||||||
Issuance of shares under employee stock purchase plan, Shares | 72,735 | |||||||||||||||
Unrealized gain (loss) on available for sale securities | 73 | 73 | ||||||||||||||
Net loss | (170,295) | (170,295) | ||||||||||||||
Ending Balance, Value at Dec. 31, 2019 | 331,137 | $ 10 | $ 37,432 | 1,050,695 | (757,019) | 19 | ||||||||||
Ending Balance, Shares at Dec. 31, 2019 | 97,783,476 | 350,000 | ||||||||||||||
Issuance of series A convertible preferred stock, net of commissions and beneficial conversion charge, Value | $ (1,305) | $ 1,305 | ||||||||||||||
Issuance of Series A Convertible Preferred Stock, net of commissions and beneficial conversion charge, Shares | 122,000 | (12,200) | ||||||||||||||
Accretion of series A convertible preferred stock | 0 | |||||||||||||||
Issuance of common stock, Value | $ 49,915 | $ 49,915 | ||||||||||||||
Issuance of common stock, Shares | 2,500,000 | |||||||||||||||
Exercise of stock options and vesting of restricted stock units, Value | 6,692 | 6,692 | ||||||||||||||
Exercise of stock options and vesting of restricted stock units, Shares | 1,097,280 | |||||||||||||||
Stock-based compensation | 27,471 | 27,471 | ||||||||||||||
Stock in lieu of board fees | 138 | 138 | ||||||||||||||
Stock in lieu of board fees, Shares | 8,683 | |||||||||||||||
Issuance of shares under employee stock purchase plan, Value | 1,254 | 1,254 | ||||||||||||||
Issuance of shares under employee stock purchase plan, Shares | 115,631 | |||||||||||||||
Unrealized gain (loss) on available for sale securities | (16) | 16 | ||||||||||||||
Net loss | (231,694) | 231,694 | ||||||||||||||
Ending Balance, Value at Dec. 31, 2020 | 184,897 | $ 10 | $ 36,127 | 1,137,470 | (988,713) | (3) | ||||||||||
Ending Balance, Shares at Dec. 31, 2020 | 101,627,070 | 337,800 | ||||||||||||||
Accretion of series A convertible preferred stock | 0 | |||||||||||||||
Issuance of common stock, Value | 15,954 | 15,953 | ||||||||||||||
Issuance of common stock, Shares | 3,840,977 | |||||||||||||||
Exercise of stock options and vesting of restricted stock units, Value | 916 | 916 | ||||||||||||||
Exercise of stock options and vesting of restricted stock units, Shares | 290,872 | |||||||||||||||
Stock-based compensation | 26,597 | 26,597 | ||||||||||||||
Stock in lieu of board fees | 190 | 190 | ||||||||||||||
Stock in lieu of board fees, Shares | 35,365 | |||||||||||||||
Issuance of shares under employee stock purchase plan, Value | 1,880 | 1,880 | ||||||||||||||
Issuance of shares under employee stock purchase plan, Shares | 303,244 | |||||||||||||||
Unrealized gain (loss) on available for sale securities | 0 | 0 | ||||||||||||||
Net loss | (251,122) | (251,122) | ||||||||||||||
Ending Balance, Value at Dec. 31, 2021 | $ (20,688) | $ 11 | $ 36,127 | $ 1,183,006 | $ (1,239,835) | $ (3) | ||||||||||
Ending Balance, Shares at Dec. 31, 2021 | 106,097,528 | 337,800 |
Consolidated Statements of St_2
Consolidated Statements of Stockholders' Equity (Parenthetical) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Issuance of common stock, commissions and offering costs | $ 284 | $ 515 | |
Put Option | |||
Financing Cost | $ 85 | ||
Royalty Pharma [Member] | |||
Issuance of common stock, commissions and offering costs | $ 304 |
The Company
The Company | 12 Months Ended |
Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
The Company | 1. The Company Epizyme, Inc. (collectively referred to with its wholly owned, controlled subsidiary, Epizyme Securities Corporation, as “Epizyme” or the “Company”) is a commercial-stage biopharmaceutical company that is committed to rewriting treatment for people with cancer through the discovery, development, and commercialization of novel epigenetic medicines. The Company aspires to change the standard of care for patients and physicians by developing targeted medicines with fundamentally new mechanisms of action directed at specific causes of hematological malignancies and solid tumors. Through December 31, 2021, in addition to revenues from product sales, the Company has raised, an aggregate of $ 1,568.3 million to fund its operations. This includes $ 268.8 million of non-equity funding through its collaboration agreements, $ 368.1 million of funding, consisting of $ 150.0 million in equity funding received through agreements with RPI Finance Trust ("RPI"), and $ 218.1 million in debt financing received through a loan agreement with BioPharma Credit Investments V (Master) LP and BPCR Limited Partnership (as transferee of BioPharma Credit Investments V (Master) LP’s interest as a lender), ("the Lenders"), $ 855.4 million from the sale of common stock and series A convertible preferred stock in the Company’s public and at-the-market offerings and $ 76.0 million from the sale of redeemable convertible preferred stock in private financings prior to the Company’s initial public offering in May 2013 . As of December 31, 2021, the Company had $ 176.8 million in cash, cash equivalents and marketable securities. In 2020, the Company’s EZH2 inhibitor, tazemetostat, was approved in the United States as TAZVERIK for the treatment of epithelioid sarcoma ("ES") and follicular lymphoma ("FL"). Commercial sales of TAZVERIK for the treatment of ES commenced in the first quarter of 2020 and commercial sales of TAZVERIK for the treatment of FL commenced in the second quarter of 2020. The Company commenced active operations in early 2008. Since its inception, the Company has generated an accumulated deficit of $ 1,239.8 million through December 31, 2021 and will require substantial additional capital to fund its research, development, and commercialization efforts. The Company is subject to risks common to companies in the biotechnology industry, including, but not limited to, risks of failure of commercialization, clinical trials and preclinical studies, the need to obtain additional financing to fund the future development and commercialization of tazemetostat and the rest of its pipeline, the need to obtain marketing approval for its product candidates, the need to successfully commercialize and gain market acceptance TAZVERIK and of any product candidates that may be approved in the future, the impact of the COVID-19 pandemic on the Company’s business, results of operations, and financial condition, dependence on key personnel, protection of proprietary technology, compliance with government regulations, development by competitors of technological innovations and ability to transition from clinical-stage manufacturing to commercial-stage production, marketing and sale of products. Operating Cost Reduction On August 9, 2021, the Company announced a cross-functional reduction of approximately 11 % of its then current workforce under a cost reduction plan. Affected employees were offered separation benefits, including severance payments along with temporary healthcare coverage assistance. The severance and termination-related costs totaled approximately $ 2.0 million, $ 1.6 million of which were recorded as selling general and administrative expenses and $ 0.4 million of which was recorded as research and development expenses in the third quarter of 2021. The Company expects that payments of these costs will be made through August 2022. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation and Principles of Consolidation The consolidated financial statements of the Company included herein have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission, or the SEC, and in accordance with U.S. generally accepted accounting principles, or GAAP. Any reference in these notes to applicable guidance is meant to refer to the authoritative accounting principles generally accepted in the United States as found in the ASC and Accounting Standards Update, or ASU, of the Financial Accounting Standards Board, or FASB. The consolidated financial statements include the accounts of Epizyme, Inc. and its wholly owned, controlled subsidiary, Epizyme Securities Corporation. All intercompany transactions and balances of subsidiaries have been eliminated in consolidation. Use of Estimates The preparation of these consolidated financial statements in accordance with accounting principles generally accepted in the United States requires management to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities, as of the date of the consolidated financial statements, and the reported amounts of revenue and expenses during the reporting period. Actual results and outcomes may differ materially from management’s estimates, judgments and assumptions. Subsequent Events The Company considers events or transactions that occur after the balance sheet date but before the consolidated financial statements are issued to provide additional evidence relative to certain estimates or to identify matters that require additional disclosure. The Company evaluated all events and transactions through the date these financial statements were filed with the Securities and Exchange Commission. Cash and cash equivalents The Company considers all highly liquid securities with original final maturities of three months or less from the date of purchase to be cash equivalents. Cash and cash equivalents are comprised of demand deposit accounts, funds in money market accounts, commercial paper and corporate notes. Marketable securities The Company classifies marketable securities with a remaining maturity when purchased of greater than three months as available-for-sale. The Company considers all available-for-sale securities, including those with maturity dates beyond 12 months, as available to support current operational liquidity needs and therefore classifies all securities with maturity dates beyond 90 days at the date of purchase as current assets. Available-for-sale securities are maintained by the Company’s investment managers and may consist of commercial paper, high-grade corporate notes, U.S. Treasury securities, and U.S. government agency securities. Available-for-sale securities are carried at fair value with the unrealized gains and losses included in other comprehensive loss as a component of stockholders’ equity until realized. Any premium or discount arising at purchase is amortized and/or accreted to interest income and/or expense over the life of the instrument. Realized gains and losses are determined using the specific identification method and are included in other income (expense). The aggregate fair value of securities held by the Company in an unrealized loss position for less than twelve months as of December 31, 2021 was $ 28.6 million, which consisted of 4 commercial paper securities and 6 U.S. Treasury securities. There were no marketable securities held by the Company for greater than twelve months as of December 31, 2021. The aggregate fair value of securities held by the Company in an unrealized loss position for less than twelve months as of December 31, 2020 was $ 67.7 million, which consisted of 6 commercial paper securities, 7 corporate notes securities and 1 U.S. Treasury security. There were no marketable securities held by the Company for greater than twelve months as of December 31, 2020. The Company does not intend to sell and it is unlikely that the Company will be required to sell the above investments before recovery of their amortized cost bases, which may be maturity. The Company determined there was no material change in the credit risk of the above investments, and as a result, the Company determined it did no t hold any investments with an other-than-temporary impairment as of December 31, 2021 and 2020. The Company reviews its portfolio of available-for-sale debt securities, using both quantitative and qualitative factors, to determine if declines in fair value below cost have resulted from a credit-related loss or other factors. If the decline in fair value is due to credit-related factors, a loss is recognized in net income, whereas if the decline in fair value is not due to credit-related factors, the loss is recorded in other comprehensive income (loss). The following table summarizes the available for sale securities held at December 31, 2021 (in thousands): Description Amortized Cost Unrealized Unrealized Fair Value Commercial paper $ 68,427 $ 7 $ ( 3 ) $ 68,431 Corporate notes — — — — U.S. government agency securities and U.S. Treasuries 10,025 — ( 1 ) 10,024 Total $ 78,452 $ 7 $ ( 4 ) $ 78,455 The following table summarizes the available for sale securities held at December 31, 2020 (in thousands): Description Amortized Cost Unrealized Unrealized Fair Value Commercial paper $ 158,907 $ 14 $ ( 8 ) $ 158,913 Corporate notes 33,437 3 ( 7 ) 33,433 U.S. government agency securities and U.S. Treasuries 13,044 1 — 13,045 Total $ 205,388 $ 18 $ ( 15 ) $ 205,391 Certain short-term debt securities with original maturities of less than 90 days are included in cash and cash equivalents within the consolidated balance sheets and are not included in the tables above. All marketable securities held at December 31, 2021 and December 31, 2020 have maturities of less than one year. The amortized cost of available-for-sale securities is adjusted for amortization of premiums and accretion of discounts to maturity. At December 31, 2021, the balance in the Company’s accumulated other comprehensive loss was composed mainly of activity related to the Company’s available-for-sale marketable securities. There were no realized gains or losses recognized on the sale or maturity of available-for-sale securities during the year ended December 31, 2021 and December 31, 2020 , respectively, and as a result, the Company did not reclassify any amounts out of accumulated other comprehensive loss for the same period. Restricted Cash A reconciliation of cash, cash equivalents, and restricted cash reported within the consolidated balance sheets that sum to the total of the same such amounts shown in the consolidated statements of cash flows, is as follows: December 31, 2021 2020 2019 (In thousands) Cash and cash equivalents $ 98,336 $ 168,215 $ 139,482 Restricted cash, as part of other assets 1,509 1,509 1509 Total cash, cash equivalents, and restricted cash shown in the consolidated statements of cash flows $ 99,845 $ 169,724 $ 140,991 The $ 1.5 million in restricted cash is comprised of $ 0.5 million in a letter of credit as a security deposit for the office and laboratory lease at Technology Square in Cambridge, Massachusetts and $ 1.0 million in a letter of credit as a security deposit for the Company’s office lease at Hampshire Street in Cambridge, Massachusetts. The Company has recorded cash held to secure these letters of credit as restricted cash in restricted cash and other assets on the consolidated balance sheet. The restricted cash is classified as non-current based on the related lease terms. Fair Value Measurements The FASB Codification Topic 820, Fair Value Measurements and Disclosures, requires the use of valuation techniques that are consistent with the market approach, the income approach and/or the cost approach. The market approach uses prices and other relevant information generated by market transactions involving identical or comparable assets and liabilities. The income approach uses valuation techniques to convert future amounts, such as cash flows or earnings, to a single present amount on a discounted basis. The cost approach is based on the amount that currently would be required to replace the service capacity of an asset (replacement cost). Valuation techniques should be consistently applied. GAAP also establishes a fair value hierarchy which requires an entity to maximize the use of observable inputs, where available, and minimize the use of unobservable inputs when measuring fair value. The standard describes three levels of inputs that may be used to measure fair value: Level 1 Quoted prices in active markets for identical assets or liabilities. Level 2 Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Level 3 Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. The Company’s financial instruments as of December 31, 2021 and 2020 consisted primarily of cash and cash equivalents, marketable securities and accounts receivable and accounts payable. As of December 31, 2021 and December 31, 2020, the Company’s financial assets recognized at fair value consisted of the following: Fair Value as of December 31, 2021 Total Level 1 Level 2 Level 3 (In thousands) Cash equivalents $ 88,637 $ 67,209 $ 21,428 $ — Marketable securities: Commercial paper 68,431 — 68,431 — Corporate notes — — — — U.S. government agency securities and treasuries 10,024 — 10,024 — Total $ 167,092 $ 67,209 $ 99,883 $ — Fair Value as of December 31, 2020 Total Level 1 Level 2 Level 3 (In thousands) Cash equivalents $ 163,264 $ 113,505 $ 49,759 $ — Marketable securities: Commercial paper 158,913 — 158,913 — Corporate notes 33,433 — 33,433 — U.S. government agency securities and treasuries 13,045 — 13,045 — Total $ 368,655 $ 113,505 $ 255,150 $ — Cash equivalents and marketable securities have been initially valued at the transaction price and subsequently valued, at the end of each reporting period, utilizing third-party pricing services or other market observable data. The Company measures its cash equivalents at fair value on a recurring basis, which approximates the net asset value per share. The Company classifies some of its cash equivalents within Level 1 of the fair value hierarchy because they are valued using observable inputs that reflect quoted prices for identical assets in active markets. The Company measures its marketable securities at fair value on a recurring basis and classifies those instruments and some cash equivalents within Level 2 of the fair value hierarchy. The pricing services used by management utilize industry standard valuation models, including both income and market-based approaches and observable market inputs to determine the fair value of marketable securities and those cash equivalents classified within Level 2 of the fair value hierarchy. As of December 31, 2021, the fair value of the long-term debt, payable in installments through November 18, 2026, approximated its carrying value due to the proximity of the issuance of the Tranche D Loan date to December 31, 2021 (See Note 13, Long-Term Debt ). Amortization of Debt Discount and Issuance Costs Long-term debt is initially recorded at its allocated proceeds, net of discounts and deferred costs. Debt discount and issuance costs, consisting of legal and other fees directly related to the debt, are offset against initial carrying value of the debt and are amortized to interest expense over the estimated life of the debt based on the effective interest method. Liability Related to Sale of Future Royalties The Company treats the liability related to sale of future royalties as a debt financing, as the Company has significant continuing involvement in the generation of the cash flows, to be amortized to interest expense using the effective interest rate method over the life of the related royalty stream. The liability related to sale of future royalties and the related interest expense are based on the Company’s current estimates of future royalties expected to be paid over the life of the arrangement. The Company will periodically assess the expected royalty payments using a combination of internal projections and forecasts from external sources. To the extent the Company’s future estimates of royalty payments are greater or less than previous estimates or the estimated timing of such payments is materially different than its previous estimates, the Company will adjust its effective interest rate, which is applied prospectively. For further discussion of the sale of future royalties, refer to Note 12, Sale of Future Royalties . Going Concern At each reporting period, the Company evaluates whether there are conditions or events that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the financial statements are issued. The Company is required to make certain additional disclosures if it concludes substantial doubt exists about the Company's ability to continue as a going concern within one year after the date that the financial statements are issued and such doubt is not alleviated by the Company’s plans or when its plans alleviate substantial doubt about the Company’s ability to continue as a going concern. The Company’s evaluation entails analyzing prospective operating budgets and forecasts for expectations of the Company’s cash needs, and comparing those needs to its available cash, cash equivalents and marketable securities. The Company has recurring losses and expects to have recurring losses for the foreseeable future with the continued commercialization of TAZVERIK in ES and FL, the development of tazemetostat in other indications, and the development of the Company’s other product candidates. In addition, the Company has experienced and continues to experience challenges in the continued commercialization of TAZVERIK resulting from the ongoing COVID-19 pandemic, which the Company believes has had an adverse impact on TAZVERIK revenues. In response to the challenges that the Company has continued to face since the Company commenced its launch of TAZVERIK in FL in June 2020, the Company implemented an operational cost reduction plan that was announced on August 9, 2021 and continues to evaluate its costs on an on-going basis with the intent to streamline such costs. The analysis of the Company’s ability to continue as a going concern for the year ended December 31, 2021 included consideration of the Company’s current cash needs, including its research and development plans, commercialization activities associated with the continued commercialization of TAZVERIK in the ES and FL indications, its existing debt service obligations, and anticipated cost savings resulting from its operational cost reduction plan, including ongoing efforts to eliminate costs not related to the Company’s strategic focus. The analysis included forecasted product revenues from sales of TAZVERIK. Such estimates of future sales contain significant judgment as TAZVERIK was first launched in the first half of 2020 and there is little history with which to base such estimates. In addition, the Company’s ongoing efforts to eliminate costs not related to the Company’s strategic focus contains uncertainties as to whether the Company can attain such benefits. Based on the analysis, the Company concluded that its available cash, cash equivalents and marketable securities as of December 31, 2021 combined with the $79.5 million raised in January 2022 (see Note 18 for further information) will be sufficient to fund current planned operations and capital expenditure requirements and pay its debt service obligations as they become due into the third quarter of 2023 which is at least 12 months from the filing date of this Annual Report on Form 10-K with the SEC. As a result, the Company concluded that it did not identify conditions or events that raise substantial doubt about the Company’s ability to continue as a going concern within one year from the date these financial statements were issued. The Company’s current operating plan is based on assumptions that may prove to be wrong, and the Company could use its capital resources sooner than it expects, in which case the Company would evaluate further reductions in its expenses or obtaining additional financing sooner than it otherwise would, which additional financing may not be available or may only be available on terms that are not acceptable to the Company. Accounts Receivable The Company extends credit to customers based on its evaluation of the customer’s financial condition. The Company records receivables for all billings when amounts are due under standard terms. Accounts receivable are stated at amounts due net of applicable prompt pay discounts and other contractual adjustments as well as an allowance for doubtful accounts. The Company assesses the need for an allowance for doubtful accounts by considering a number of factors, including the length of time trade accounts receivable are past due, the customer’s ability to pay its obligation and the condition of the general economy and the industry as a whole. The Company will write off accounts receivable when the Company determines that they are uncollectible. In general, the Company has experienced no significant collection issues with its customers. Concentration of Credit Risk Financial instruments that potentially subject the Company to concentrations of credit risk include cash, cash equivalents, marketable securities and accounts receivable. The Company attempts to minimize the risks related to cash, cash equivalents and marketable securities by working with highly rated financial institutions that invest in a broad and diverse range of financial instruments as defined by the Company. The Company has established guidelines relative to credit ratings and maturities intended to safeguard principal balances and maintain liquidity. The Company maintains its funds in accordance with its investment policy, which defines allowable investments, specifies credit quality standards and is designed to limit the Company’s credit exposure to any single issuer. Accounts receivable represent amounts due from customers and collaboration partners. The Company monitors economic conditions to identify facts or circumstances that may indicate that any of its accounts receivable are at risk of collection. For a further discussion of concentration of credit risk see Note 3, Product Revenue, Net . Property and Equipment The Company records property and equipment at cost. Property and equipment acquired under a capital lease is recorded at the lesser of the present value of the minimum lease payments under the capital lease or the fair value of the leased property at lease inception. The Company calculates depreciation and amortization using the straight-line method over the following estimated useful lives: Asset Category Useful Lives Laboratory equipment 3 - 6 years Computer and office equipment, and furniture 3 - 10 years Leasehold improvements 3 - 6 years or term of respective lease, if shorter Amortization of capital lease assets is included in depreciation expense. The Company capitalizes expenditures for new property and equipment and improvements to existing facilities and charges the cost of maintenance to expense. The Company eliminates the cost of property retired or otherwise disposed of, along with the corresponding accumulated depreciation, from the related accounts, and the resulting gain or loss is reflected in the results of operations. Impairment of Long-Lived Assets The Company reviews long-lived assets to be held and used, including property and equipment and intangible assets, for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets or asset group may not be recoverable. Evaluation of recoverability is based on an estimate of undiscounted future cash flows resulting from the use of the asset or asset group and its eventual disposition. In the event that such cash flows are not expected to be sufficient to recover the carrying amount of the asset or asset group, the assets are written down to their estimated fair values. No such impairments were recorded during 2021, 2020 or 2019 . Income Taxes The Company records deferred income taxes to recognize the effect of temporary differences between tax and financial statement reporting. The Company calculates the deferred taxes using enacted tax rates expected to be in place when the temporary differences are realized and records a valuation allowance to reduce deferred tax assets if it is determined that it is more likely than not that all or a portion of the deferred tax asset will not be realized. The Company considers many factors when assessing the likelihood of future realization of deferred tax assets, including recent earnings results, expectations of future taxable income, carryforward periods available and other relevant factors. The Company records changes in the required valuation allowance in the period that the determination is made. The Company assesses its income tax positions and records tax benefits for all years subject to examination based upon management’s evaluation of the facts, circumstances and information available as of the reporting date. For those tax positions where it is more likely than not that a tax benefit will be sustained, the Company records the largest amount of tax benefit with a greater than 50.0 % likelihood of being realized upon ultimate settlement with a taxing authority having full knowledge of all relevant information. For those income tax positions where it is not more likely than not that a tax benefit will be sustained, the Company does not recognize a tax benefit in the financial statements. The Company records interest and penalties related to uncertain tax positions, if applicable, as a component of income tax expense. Refer to Note 8, Income Taxes , for additional information regarding the Company’s income taxes. Revenue Recognition – Collaboration Revenue Under ASC 606, Revenue from Contracts with Customers , an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. The Company has entered into collaboration and license agreements, which are within the scope of ASC 606, to discover, develop, manufacture and commercialize product candidates. The terms of these agreements typically contain multiple promises or obligations, which may include: (i) licenses, or options to obtain licenses, to compounds directed to specific targets (referred to as “exclusive licenses”) and (ii) research and development activities to be performed on behalf of the collaboration partner related to the licensed targets. Payments to the Company under these agreements may include non-refundable license fees, customer option exercise fees, payments for research activities, reimbursement of certain costs, payments based upon the achievement of certain milestones and royalties on any resulting net product sales. The Company first evaluates license and/or collaboration arrangements to determine whether the arrangement (or part of the arrangement) represents a collaborative arrangement pursuant to ASC Topic 808, Collaborative Arrangements, based on the risks and rewards and activities of the parties pursuant to the contractual arrangement. The Company accounts for collaborative arrangements (or elements within the contract that are deemed part of a collaborative arrangement) , which represent a collaborative relationship and not a customer relationship, outside the scope of ASC 606. The Company’s collaborations primarily represent revenue arrangements. The Company uses judgment to determine whether milestones or other variable consideration, except for sales-based royalties, should be included in the transaction price as described further below. The transaction price is allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. In determining the stand-alone selling price of a license to the Company’s proprietary technology or a material right provided by a customer option, the Company considers market conditions as well as entity-specific factors, including those factors contemplated in negotiating the agreements as well as internally developed estimates that include assumptions related to the market opportunity, estimated development costs, probability of success and the time needed to commercialize a product candidate pursuant to the license. In validating its estimated stand-alone selling price, the Company evaluates whether changes in the key assumptions used to determine its estimated stand-alone selling price will have a significant effect on the allocation of arrangement consideration between performance obligations. Amounts received prior to revenue recognition are recorded as deferred revenue. Amounts expected to be recognized as revenue within the 12 months following the balance sheet date are classified as current portion of deferred revenue in the accompanying consolidated balance sheets. Amounts not expected to be recognized as revenue within the 12 months following the balance sheet date are classified as deferred revenue, net of current portion. Amounts recognized as revenue, but not yet received or invoiced are generally recognized as contract assets. Exclusive Licenses – If the license to the Company’s intellectual property is determined to be distinct from the other promises or performance obligations identified in the arrangement, which generally include research and development services, the Company recognizes revenue from non-refundable, upfront fees allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. In assessing whether a license is distinct from the other promises, the Company considers relevant facts and circumstances of each arrangement, including the research and development capabilities of the collaboration partner and the availability of the associated expertise in the general marketplace. In addition, the Company considers whether the collaboration partner can benefit from the license for its intended purpose without the receipt of the remaining promises, whether the value of the license is dependent on the unsatisfied promises, whether there are other vendors that could provide the remaining promises, and whether it is separately identifiable from the remaining promises. For licenses that are combined with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. The measure of progress, and thereby periods over which revenue should be recognized, are subject to estimates by management and may change over the course of the research and development and licensing agreement. Research and Development Services – The promises under the Company’s collaboration and license agreements generally include research and development services to be performed by the Company on behalf of the collaboration partner. For performance obligations that include research and development services, the Company generally recognizes revenue allocated to such performance obligations based on an appropriate measure of progress. The Company utilizes judgment to determine the appropriate method of measuring progress for purposes of recognizing revenue, which is generally an input measure such as costs incurred. The Company evaluates the measure of progress each reporting period as described under Exclusive Licenses above. Reimbursements from the partner that are the result of a collaborative relationship with the partner, instead of a customer relationship, such as co-development activities, are recorded as a reduction to research and development expense. Customer Options – The Company’s arrangements may provide a collaborator with the right to select a target for licensing either at the inception of the arrangement or within an initial pre-defined selection period, which may, in certain cases, include the right of the collaborator to extend the selection period. Under these agreements, fees may be due to the Company (i) at the inception of the arrangement as an upfront fee or payment, (ii) upon the exercise of an option to acquire a license or (iii) upon extending the selection period as an extension fee or payment. If an arrangement is determined to contain customer options that allow the customer to acquire additional goods or services, the goods and services underlying the customer options are not considered to be performance obligations at the outset of the arrangement, as they are contingent upon option exercise. The Company evaluates the customer options for material rights, or options to acquire additional goods or services for free or at a discount. If the customer options are determined to represent a material right, the material right is recognized as a separate performance obligation at the inception of the arrangement. The Company allocates the transaction price to material rights based on the relative stand-alone selling price, which is determined based on the identified discount and the probability that the customer will exercise the option. Amounts allocated to a material right are not recognized as revenue until, at the earliest, the option is exercised or expires. Milestone Payments – At the inception of each arrangement that includes development milestone payments, the Company evaluates whether the milestones are considered probable of being achieved and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The Company evaluates factors such as the scientific, clinical, regulatory, commercial, and other risks that must be overcome to achieve the particular milestone in making this assessment. There is considerable judgment involved in determining whether it is probable that a significant revenue reversal would not occur. At the end of each subsequent reporting period, the Company reevaluates the probability of achievement of all milestones subject to constraint and, if necessary, adjusts its estimate of t |
Product Revenue Net
Product Revenue Net | 12 Months Ended |
Dec. 31, 2021 | |
TAZVERIK [Member] | |
Concentration Risk [Line Items] | |
Product Revenue Net | 3. Product Revenue, Net The Company sells TAZVERIK in the United States principally to a limited number of specialty pharmacies, which dispense the product directly to patients, and specialty distributors, which in turn sell the product to hospital pharmacies and community practice pharmacies (collectively, healthcare providers) for the treatment of patients. The specialty pharmacies and specialty distributors are referred to as the Company’s customers. Product revenue is recognized by the Company in an amount that reflects the consideration which the Company expects to receive in exchange for those goods or services when the customer obtains control of the product, which occurs at a point in time, typically when the product is received by the Company’s customers. The Company provides a right of return to its customers for unopened product for a limited time before and after its expiration date, which right of return lapses upon shipment to a patient. Healthcare providers to whom specialty distributors sell TAZVERIK hold limited inventory that is designated for patients, and the Company monitors inventory levels in the distribution channel, to limit the risk of return. Reserves for Variable Consideration Revenues from product sales are recorded as product revenue at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established and which result from discounts, returns, chargebacks, rebates, co-pay assistance and other allowances that are offered within contracts between the Company and its customers, health care providers, payors and other indirect customers relating to the Company’s product sales. These reserves are based on the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (if the amount is payable to the customer) or a current liability (if the amount is payable to a party other than a customer). Where appropriate, these estimates take into consideration a range of possible outcomes that are probability-weighted for relevant factors such as the Company’s historical experience, current contractual and statutory requirements, specific known market events and trends, industry data and forecasted customer buying and payment patterns. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which the Company is entitled based on the terms of the contract(s). The amount of variable consideration that is included in the transaction price may be constrained, and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. Actual amounts of consideration ultimately received may differ from the Company’s estimates. If actual results in the future vary from the Company’s estimates, the Company will adjust these estimates, which would affect net product revenue and earnings in the period such variances become known. Trade Discounts and Allowances : The Company generally provides customers with discounts that include incentive fees that are explicitly stated in customer contracts and are recorded as a reduction of revenue in the period the related product revenue is recognized. In addition, the Company receives sales order management, data and distribution services from certain customers. To the extent the services received are distinct from the Company’s sale of products to the customer, these payments are classified in selling, general and administrative expenses in the consolidated statements of operations and comprehensive loss. Product Returns : Consistent with industry practice, the Company generally offers customers a limited right of return based on the product’s expiration date for product that has been purchased from the Company, which lapses upon shipment to a patient. The Company estimates the amount of product sales that may be returned by customers and records this estimate as a reduction of revenue in the period in which the related product revenue is recognized. The Company currently estimates product return liabilities using available industry data and the Company’s own historical sales information, including its visibility into the product remaining in the distribution channel. Provider Chargebacks and Discounts : Chargebacks for fees and discounts to healthcare providers represent the estimated obligations resulting from contractual commitments to sell products to qualified healthcare providers at prices lower than the list prices charged to customers who directly purchase the product from the Company. Customers charge the Company for the difference between what they pay for the product and the ultimate selling price to the qualified healthcare providers. These reserves are established in the same period that the related revenue is recognized, resulting in a reduction of product revenue and accounts receivable. Chargeback amounts are generally determined at the time of resale to the qualified healthcare provider by customers, and the Company generally issues credits for such amounts within a few weeks of the customer’s notification to the Company of the resale. Reserves for chargebacks consist of credits that the Company expects to issue for units that remain in the distribution channel at each reporting period end that the Company expects will be sold to qualified healthcare providers, and chargebacks that customers have claimed but for which the Company has not yet issued a credit. Government Rebates: The Company is subject to discount obligations under state Medicaid programs and Medicare. The Company estimates its Medicaid and Medicare rebates based upon a range of possible outcomes that are probability-weighted for the estimated payor mix. These reserves are recorded in the same period in which the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability that is included in accrued expenses on the Company’s consolidated balance sheets. For Medicare, the Company also estimates the number of patients in the prescription drug coverage gap for whom the Company will owe an additional liability under the Medicare Part D program. The Company’s liability for these rebates consists of invoices received for claims from prior quarters that have not been paid or for which an invoice has not yet been received, estimates of claims for the current quarter, and estimated future claims that will be made for product that has been recognized as revenue, but remains in the distribution channel inventories at period end. Payor Rebates: The Company may contract with various private payor organizations, primarily insurance companies and pharmacy benefit managers, for the payment of rebates with respect to utilization of the Company’s products. The Company estimates these rebates and records such estimates in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability. Other Incentives/Patient Assistance Programs: The Company also offers voluntary patient assistance programs such as co-pay assistance. Co-pay assistance programs are intended to provide financial assistance to qualified commercially insured patients with prescription drug co-payments required by payors. The calculation of the accrual for co-pay assistance is based on an estimate of claims and the cost per claim that the Company expects to receive associated with product that has been recognized as revenue, but remains in the distribution channel inventories at period end. The following table summarizes activity in each of the above product revenue allowances and reserve categories for the year ended December 31, 2021: Chargebacks, Government Fees Rebates Returns Total (In thousands) Balance, January 1, 2021 $ 133 $ 428 $ 67 $ 628 Provision 1,886 3,093 274 5,253 Payments or credits ( 1,775 ) ( 2,935 ) ( 232 ) ( 4,942 ) Balance, December 31, 2021 $ 244 $ 586 $ 109 $ 939 The following table summarizes activity in each of the above product revenue allowances and reserve categories for the year ended December 31, 2020: Chargebacks, Government Fees Rebates Returns Total (In thousands) Balance, January 1, 2020 $ — $ — $ — $ — Provision 802 1,046 67 1,915 Payments or credits ( 669 ) ( 618 ) — ( 1,287 ) Balance, December 31, 2020 $ 133 $ 428 $ 67 $ 628 Concentration of Credit Risk Financial instruments which potentially subject the Company to concentrations of credit risk consist of accounts receivable from customers and cash held at financial institutions. The Company believes that such customers and financial institutions are of high credit quality. For the years ended December 31, 2021 and 2020 , net product revenue was primarily generated from five individual customers. Revenue earned from each customer as a percentage of net product revenue is as follows: Year Ended December 31, 2021 2020 Customer 1 30 % 45 % Customer 2 11 % 11 % Customer 3 27 % 20 % Customer 4 21 % 24 % Customer 5 11 % 0 % As of December 31, 2021 and 2020, five individual customers represented as a percentage of accounts receivable as follows: December 31, December 31, Customer 1 15 % 21 % Customer 2 10 % 14 % Customer 3 22 % 29 % Customer 4 29 % 36 % Customer 5 24 % 0 % No other customer represented more than 10 percent of net product revenue or accounts receivable. |
Property and Equipment, net
Property and Equipment, net | 12 Months Ended |
Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, net | 4. Property and Equipment, net Property and equipment, net consists of the following: December 31, 2021 2020 (In thousands) Laboratory equipment $ 4,580 $ 4,435 Computer and office equipment, and furniture 4,386 4,636 Leasehold improvements 453 453 Construction in progress 157 34 Property and equipment 9,576 9,558 Less: accumulated depreciation ( 8,031 ) ( 7,406 ) Property and equipment, net $ 1,545 $ 2,152 Depreciation expense was $ 1.1 million, $ 1.0 million and $ 0.8 million for the years ended December 31, 2021, 2020, and 2019 , respectively. |
Inventory
Inventory | 12 Months Ended |
Dec. 31, 2021 | |
Inventory Disclosure [Abstract] | |
Inventory | 5. Inventory All of the Company’s inventory relates to the manufacturing of TAZVERIK. The following table sets forth the Company’s inventory as of December 31, 2021 and December 31, 2020: December 31, December 31, (In thousands) Raw materials $ 3,227 $ 1,068 Work in process 13,748 8,564 Finished goods 1,710 829 Total $ 18,685 $ 10,461 Balance sheet classification Inventory $ 3,216 $ 10,461 Restricted cash and other assets 15,469 — Total $ 18,685 $ 10,461 As of December 31, 2021, the Company has not capitalized inventory costs related to its other drug development programs. The Company’s active pharmaceutical ingredient has a long shelf life and the Company’s finished drug product has a three-year expiry, however the realizability of the inventory is subject to forecasted future sales of TAZVERIK. The Company’s forecasted sales currently support the realizability of the Company’s inventory but are uncertain and could change in the future, which would require the Company to write down the value of such inventory. Due to the revisions to the Company’s forecast of future TAZVERIK sales during the quarter ended June 30, 2021, the Company classified a portion of its inventory as long-term. |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 12 Months Ended |
Dec. 31, 2021 | |
Text Block [Abstract] | |
Prepaid Expenses and Other Current Assets | 6. Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consisted of the following: December 31, 2021 2020 (In thousands) Prepaid clinical and manufacturing costs $ 12,756 $ 12,646 Interest receivable on available for sale securities 72 369 Other prepaid expenses and other receivables 6,637 4,906 Total prepaid expenses and other current assets $ 19,465 $ 17,921 |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Dec. 31, 2021 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | 7. Accrued Expenses Accrued expenses consisted of the following: December 31, 2021 2020 (In thousands) Employee compensation and benefits $ 11,737 $ 11,921 Research and development expenses 13,744 10,664 Current portion of liability related to the sale of future royalties 273 — Professional services and other 5,023 5,987 Accrued expenses $ 30,777 $ 28,572 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 8. Income Taxes The Company’s losses before income taxes consist solely of domestic losses. The provision for (benefit from) income taxes for the years ended December 31, 2021, 2020, and 2019 is as follows: 2021 2020 2019 (In thousands) Current $ 22 $ 22 $ ( 34 ) Deferred — 92 92 Total 22 114 58 Income tax provision $ 22 $ 114 $ 58 A reconciliation of the federal statutory income tax rate and the Company’s effective income tax rate is as follows: Year Ended December 31, 2021 2020 2019 Federal statutory income tax rate 21.0 % 21.0 % 21.0 % State income taxes 5.5 6.1 6.0 Research and development and other tax credits 2.6 2.0 1.9 Permanent items 0.1 ( 0.6 ) ( 0.7 ) Change in valuation allowance ( 27.2 ) ( 27.9 ) ( 27.5 ) Other ( 2.1 ) ( 0.6 ) ( 0.7 ) Effective income tax rate 0.0 % 0.0 % 0.0 % Deferred Tax Assets (Liabilities) The Company’s deferred tax assets (liabilities) included in other assets in the consolidated balance sheets consist of the following: December 31, 2021 2020 (In thousands) Deferred tax assets: Net operating loss carryforwards $ 294,248 $ 238,792 Research and development and other credit carryforwards 41,189 34,205 Accruals and allowances 3,071 2,949 Eisai license payment 10,752 11,935 Stock compensation 8,211 7,338 Other 1,072 1,220 Sale of royalty 4,210 3,857 Lease liability 5,987 5,462 Business interest 7,060 1,220 Gross deferred tax assets 375,800 306,978 Deferred tax asset valuation allowance ( 370,500 ) ( 302,137 ) Total deferred tax assets 5,300 4,841 Deferred tax liabilities: Depreciation and other — ( 18 ) Right of use asset ( 5,300 ) ( 4,709 ) Total deferred tax liabilities ( 5,300 ) ( 4,727 ) Net deferred tax asset $ — $ 114 The Company evaluated the expected recoverability of its net deferred tax assets as of December 31, 2021 and 2020, and determined that there was insufficient positive evidence to support the recoverability of these net deferred tax assets, concluding it is more likely than not that its net deferred tax assets would not be realized in the future; therefore, the Company provided a full valuation allowance against its net deferred tax asset balance as of December 31, 2021 and 2020. As of December 31, 2021, the Company had operating loss carryforwards of approximately $ 1.1 billion and $ 1.1 billion available to offset future taxable income for United States federal and state income tax purposes, respectively. The U.S. federal tax operating loss carryforwards of $ 428.5 million will expire at various dates from 2029 through 2037 . Approximately $ 664.9 million of the U.S. federal tax operating losses can be carried forward indefinitely. The state tax operating loss carryforwards expire commencing in 2030 . Additionally, as of December 31, 2021, the Company had research and development tax credit carryforwards of approximately $ 15.6 million and $ 6.1 million available to be used as a reduction of federal income taxes and state income taxes, respectively, which expire at various dates from 2028 through 2040 , as well as federal orphan drug tax credit carryforwards of $ 20.8 million, which would expire at various dates from 2033 through 2041 . The Company’s ability to use its operating loss carryforwards and tax credits to offset future taxable income is subject to restrictions under Section 382 of the U.S. Internal Revenue Code (the “Internal Revenue Code”). These restrictions may limit the future use of the operating loss carryforwards and tax credits if certain ownership changes described in the Internal Revenue Code occur. Future changes in stock ownership may occur that would create further limitations on the Company’s use of the operating loss carryforwards and tax credits. In such a situation, the Company may be required to pay income taxes, even though significant operating loss carryforwards and tax credits exist. Uncertain Tax Positions The following is a rollforward of the Company’s unrecognized tax benefits: December 31, 2021 2020 2019 (In thousands) Unrecognized tax benefits - as of beginning of year $ 7,160 $ 6,328 $ 5,743 Gross increases - current period tax positions 1,206 832 585 Unrecognized tax benefits - as of end of year $ 8,366 $ 7,160 $ 6,328 None of the Company’s unrecognized tax benefits would result in income tax expense or impact the Company’s effective tax rate if recognized. The Company had no accrued tax-related interest or penalties as of December 31, 2021 or 2020. The Company has generated research and development and orphan drug credits, but has not conducted a study to document the qualified activities. This study may result in an adjustment to the Company’s reserve for uncertain tax positions, research and development credit, and orphan drug credit carryforwards. The Company files income tax returns in the U.S. federal tax jurisdiction and various state tax jurisdictions. Since the Company is in a loss carryforward position, the Company is generally subject to examination by the U.S. federal, state and local income tax authorities for all tax years in which a loss carryforward is available. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 9. Commitments an d Contingencies Commitments In addition to commitments under leasing arrangements (Refer to Note 10, Leases ), the Company committed to $ 10.4 million of development costs payable to Roche Molecular upon certain development and regulatory milestones, under the amended companion diagnostic agreement, and Eisai agreed to reimburse the Company $ 0.9 million of this amount related to a regulatory milestone for Japan, which Eisai paid to us in the fourth quarter of 2020. In July 2019, the Company entered into a fourth amendment to the companion diagnostics agreement. Under the amended agreement, the Company and Roche Molecular agreed to divide a $ 1.0 million regulatory milestone for the United States into two separate milestone payments, of which $ 0.5 million was paid by the Company as part of the signed amendment, and the remaining $ 0.5 million was paid by the Company in December 2019 upon the satisfaction of certain conditions set forth in the fourth amendment to the companion diagnostics agreement. As part of this fourth amendment, Roche Molecular also assigned all of its rights and obligations under the companion diagnostics agreement to Roche Sequencing due to a reorganization at Roche group, and this assignment became effective as of January 1, 2020. Through December 31, 2021 , the Company has paid Roche Sequencing $ 9.4 million under the amended agreement, including developmental costs of $ 3.4 million paid in 2020, $ 4.0 million paid in 2019 and $ 2.0 million paid in 2018, respectively, upon the achievement of milestones under the amended agreement with Roche Sequencing. As of December 31, 2021 , the Company is responsible for the remaining development costs of $ 1.0 million due under the agreement. In addition, the Company paid $ 1.0 million to Roche Sequencing for the achievement of a development milestone in the fourth quarter of 2020. Additionally, the Company enters into contracts in the normal course of business with clinical research organizations for clinical and preclinical research studies, external manufacturers for product for use in clinical trials, and other research supplies and other services as part of the Company’s operations. These contracts generally provide for termination on notice, and therefore are cancelable contracts and not included in contractual commitments. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2021 | |
Leases [Abstract] | |
Leases | 10. Leases The Company enters into lease arrangements for its facilities as well as certain equipment. A summary of the arrangements are as follows: Operating Leases The Company leases office and laboratory space at Technology Square in Cambridge, Massachusetts under a Lease Agreement, dated as of June 15, 2012, as amended, or the Technology Square Lease, with ARE-TECH Square, LLC, a Delaware limited liability company. In May 2017, the Company exercised its option to extend the term of the Technology Square Lease to November 30, 2022. Under the Technology Square Lease as amended, the Company agreed to pay a monthly base rent of approximately $ 0.2 million for the period commencing December 1, 2017 through May 31, 2018, with an increase on June 1, 2018 of approximately $ 33,000 and annual increases of approximately $ 9,000 on December 1 of each subsequent year until the last increase, which will occur on December 1, 2021. On August 11, 2021, the Company, entered into a fifth amendment to the Technology Square Lease (the “Fifth Amendment”) with ARE-TECH Square, LLC. Under the Fifth Amendment, the Company extended the term of the Technology Square Lease through November 30, 2024. Under the Fifth Amendment, the Company will continue to pay the Landlord the current monthly base rent amount contemplated by the Technology Square Lease through November 30, 2022, with an increase commencing on December 1, 2022 and adjusting the monthly base rent amount to approximately $ 377,000 and an increase commencing on December 1, 2023 and adjusting the monthly base rent amount to approximately $ 388,000 through November 30, 2024. In addition, under the Fifth Amendment, the Landlord agreed to provide the Company with a tenant improvement allowance of up to approximately $ 430,000 if requested by the Company by August 11, 2022, subject to specified terms and conditions. In accordance with ASU 2016-02, Leases, or ASC 842, the Company accounted for the Fifth Amendment as a lease modification and remeasured the operating lease liability, resulting in an additional $ 7.0 million operating lease liability and right of use asset. Under the current terms of the Technology Square Lease, the Company does not have any further right to extend the term beyond November 30, 2024. The Company has a $ 0.5 million letter of credit as a security deposit for the Technology Square Lease and has recorded cash held to secure this letter of credit as restricted cash and other assets on the consolidated balance sheet. On August 16, 2019, the Company entered into a lease, or the Hampshire Street Lease, with BMR-Hampshire LLC, or BMR. The Hampshire Street Lease is for 33,525 rentable square feet of office space in Cambridge, Massachusetts. The Hampshire Street Lease commenced as of December 1, 2019 . The Hampshire Street Lease has an initial term of seven years and four months from the commencement date and provides the Company with an option to extend the lease term for one additional five-year period . After a four-month period during which base rent was not payable, the Hampshire Street Lease provides for monthly rent payments starting at approximately $ 0.2 million and increasing 2.5 % per year. In the event that the Company exercises its option to extend the lease term, the Hampshire Street Lease provides for monthly rent payments during the additional five-year period at the greater of the base rent rate at the end of the initial term or the then-current market rent. The Company has a $ 1.0 million letter of credit in favor of BMR as a security deposit for the Hampshire Street Lease and has recorded cash held to secure this letter of credit as restricted cash and other assets on the consolidated balance sheet. In applying ASC 842, the Company determined the classification of the Hampshire Street Lease to be operating and recorded a lease liability and a right-of-use asset as of December 31, 2019. The Company is required to pay certain variable costs to its landlords in addition to fixed rent. These costs include common area maintenance, real estate taxes, and parking and are included in lease expense. The following table c ontains a summary of the lease costs recognized under ASC 842 and other information pertaining to the Company’s operating leases for the years ended December 31, 2021, 2020 and 2019: Twelve months ended Twelve months ended Twelve months ended 2021 2020 2019 Lease cost Operating lease cost $ 6,291 $ 6,155 $ 3,771 Variable lease cost 2,039 1,764 1,318 Total lease cost $ 8,330 $ 7,919 $ 5,089 Other information Operating cash flows used for operating leases $ 6,436 $ 4,374 $ 3,648 Weighted average remaining lease term 4.2 years 5.3 years 5.3 years Weighted average discount rate 9.74 % 9.77 % 9.60 % Future minimum lease payments under the Company’s non-cancelable operating leases as of December 31, 2021, are as follows: 2021 (In thousands) 2022 $ 6,202 2023 7,517 2024 7,322 2025 3,057 Thereafter 3,909 Total lease payments $ 28,007 Less: imputed interest ( 5,356 ) Total operating lease liabilities at December 31, 2021 $ 22,651 |
Collaborations
Collaborations | 12 Months Ended |
Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Collaborations | 11. Collabo rations HutchMed On August 7, 2021 , the Company entered into a strategic collaboration pursuant to a license agreement (the “HutchMed License Agreement”) with Hutchison China MediTech Investment Limited (“HutchMed”) for the development, manufacture and commercialization of tazemetostat, either as a monotherapy or as a part of combinations with other therapies, including HutchMed proprietary compounds, agreed by the parties under the HutchMed License Agreement (“Licensed Products”) for the treatment of epithelioid sarcoma, follicular lymphoma, diffuse large B-cell lymphoma in humans, and any additional indications agreed by the parties in accordance with the terms of the HutchMed License Agreement (the “Field”) in mainland China, Taiwan, Hong Kong and Macau (each, a “Jurisdiction”, and collectively, the “Territory”). Agreement Structure The Company has granted HutchMed licenses under patent rights and know-how controlled by the Company to enable HutchMed to develop and commercialize Licensed Products in the Field in the Territory. The licenses granted to HutchMed are co-exclusive with the Company with respect to the development of Licensed Products in the Field in the Territory and exclusive with respect to the commercialization of Licensed Products in the Field in the Territory. The Company also granted HutchMed a license under patent rights and know-how controlled by the Company to enable HutchMed to manufacture tazemetostat drug substance and drug product for the purpose of developing and commercializing Licensed Products in the Field in the Territory. The Company retains development and commercialization rights with respect to Licensed Products in the rest of the world outside of the Territory except for Japan. The Company has agreed to conduct a technology transfer of manufacturing technology to HutchMed to enable HutchMed to manufacture clinical and commercial quantities of tazemetostat drug substance and drug product to carry out its obligations and exercise its rights under the HutchMed License Agreement. Subject to the execution of a clinical supply agreement or commercial supply agreement, as applicable, and until the completion of the technology transfer to HutchMed, the Company has agreed to manufacture and supply HutchMed with tazemetostat drug substance and drug product in sufficient quantities for HutchMed’s development or commercialization activities for Licensed Products in the Field in the Territory. HutchMed has agreed to use commercially reasonable efforts to carry out development activities in the Territory as agreed by the parties and to seek to obtain and maintain regulatory approval of the Licensed Products in the Territory. HutchMed agreed to use commercially reasonable efforts to commercialize Licensed Products in the Field in the Territory. HutchMed is responsible for all costs it incurs in developing, obtaining regulatory approval of, and commercializing Licensed Products in the Field in the Territory, including costs incurred by HutchMed in conducting clinical trials that only include clinical sites in the Territory. For global studies conducted by the Company that HutchMed elects to participate in by conducting any such study in the Territory, HutchMed will be responsible for enrolling and treating in the Territory 20 % of the total number of study patients of such global study and will be responsible for costs for those patients enrolled and treated in such trials. HutchMed will also be responsible for 20 % of the costs of such global studies that are not specific to any territory and the Company will be responsible for all other costs of such global studies. HutchMed has agreed to pa rticipate in the Company’s EZH-301 and SYMPHONY-1 (EZH-302) global studies, however under certain circumstances where the SYMPHONY-1 (EZH-302) global study is not considered a confirmatory trial for regulatory approval in China, the Company shall be responsible for the costs of the trial in the Territory. Pursuant to the HutchMed License Agreement, the Company received a nonrefundable upfront payment of $ 25.0 million in September 2021. The Company is also entitled to milestone payments of up to $ 110.0 million in the aggregate for achievement of specified development and regulatory milestones with respect to Licensed Products in the Territory, and up to $ 175.0 million in the aggregate for achievement of specified sales milestones in the Territory with respect to the Licensed Products. The Company will also be entitled to receive tiered royalties, ranging from a mid-teens percentage to a low twenties percentage based on HutchMed’s cumulative annual net sales, if any, of Licensed Products in the Territory. Under the HutchMed License Agreement, the Company issued a warrant to HutchMed (the “HutchMed Warrant”) , exercisable at any time prior to August 7, 2025 for up to 5,653,000 shares of the Company’s common stock at an exercise price of $ 11.50 per share. Unless earlier terminated, the HutchMed License Agreement will expire upon the expiration of the last royalty term for the last Licensed Product in the Field in the Territory. HutchMed may terminate the HutchMed License Agreement in its entirety for any or no reason upon 12 months’ prior written notice to the Company. Either party may, subject to specified cure periods, terminate the HutchMed License Agreement in the event of the other party’s uncured material breach, and under specified circumstances relating to the other party’s insolvency or if the other party or its affiliates challenges the validity, patentability, or enforceability of patent rights that are owned by or licensed to such party or its affiliates and that are subject to the licenses granted in the HutchMed License Agreement. License Revenue The Company evaluated the terms of the HutchMed License Agreement and first determined that the HutchMed Warrant should be accounted for pursuant to ASC 815, Derivatives and Hedging, with the HutchMed Warrant's fair value of approximately $ 13.0 million (Note 14) at execution considered outside of the revenue arrangement. The Company identified the following performance obligations at the inception of the HutchMed License Agreement: (1) exclusive license with rights to develop, manufacture and commercialize tazemetostat in the Territory, (2) research and development services related to global trials, and (3) a material right related to the Company’s obligation to provide clinical supply of tazemetostat. In addition, the Company may also provide certain technology transfer services related to providing HutchMed with the capability to manufacture tazemetostat, for which the Company will receive reimbursement that approximates stand-alone selling price. The Company evaluated the HutchMed License Agreement under ASC 606, Revenue from Contracts with Customers. Based on that evaluation, the $ 12.0 million of the up-front fee remaining after allocation to the HutchMed Warrant and the reimbursement to be received for its research and development services constituted the amount of the consideration to be included in the transaction price. In addition, should the global SYMPHONY-1 (EZH-302) trial not be deemed a confirmatory trial for purposes of regulatory approval in China, the Company shall be responsible for reimbursing HutchMed for the costs of the portion of the global SYMPHONY-1 (EZH-302) trial that will be performed in China. The Company concluded that this repayment provision represented variable consideration under the arrangement. Due to the uncertainty of potential repayment, which is based solely on the decision of a regulatory authority, the Company could not assert that it was probable that a significant reversal of revenue would not occur. As a result, the Company determined that the transaction price should be fully constrained. The Company will evaluate the application of the constraint on a quarterly basis and should the contingency be resolved without future payment to HutchMed for the global SYMPHONY-1 (EZH-302) trial, the full upfront fee and any reimbursement of research and development services will be included in the transaction price. In addition, should the estimated payment to HutchMed for the global SYMPHONY-1 (EZH-302) trial be determined to be less than the cumulative up-front fee and research and development reimbursement payments, such excess will be included in the transaction price. None of the development or regulatory milestones have been included in the transaction price, as all such milestone amounts were fully constrained. As part of the Company's evaluation of the constraint, the Company considered numerous factors, including that receipt of the milestones is outside the control of the Company and contingent upon success in future clinical trials and the licensee’s efforts. Any consideration related to sales-based milestones (including royalties) will be recognized when the related sales occur as these amounts have been determined to relate predominantly to the license granted to HutchMed and therefore are recognized at the later of when the performance obligation is satisfied or the related sales occur. The Company delivered the license during the third quarter of 2021 and expects that based on the estimated standalone selling price of the license, that the majority of the consideration in the arrangement will be allocated to the license performance obligation, once such consideration is no longer constrained. As the Company performs research and development services, it will recognize revenue as such services are performed, upon the transaction price no longer being fully constrained. GSK In January 2011, the Company entered into a collaboration and license agreement with Glaxo Group Limited (an affiliate of GlaxoSmithKline plc), or GSK, to discover, develop and commercialize novel small molecule HMT inhibitors directed to available targets from the Company’s platform. Under the terms of the agreement, the Company granted GSK exclusive worldwide license rights to HMT inhibitors directed to three targets. In March 2014, the Company and GSK amended certain terms of this agreement for the third licensed target, revising the license terms with respect to candidate compounds and amending the corresponding financial terms, including reallocating milestone payments and increasing royalty rates as to the third target. Subsequent to a GSK strategic portfolio prioritization, the Company received notice in October 2017 that GSK terminated the agreement with respect to the third target, effective December 31, 2017, which returned all rights to that target to the Company. On December 16, 2021, the Company received written notice from GSK that GSK elected to terminate the Collaboration and License Agreement without cause, and in accordance with the terms of the agreement and the notice of termination, the termination will be effective on March 16, 2022 . As a result of the termination of the agreement, as of the termination effective date, the license rights granted by the Company to GSK will terminate, GSK will cease to accrue any financial obligations to the Company and the Company will be entitled to pursue the PRMT5 and PRMT1 targets in all fields worldwide without further obligation to GSK. The Company substantially completed all of its obligations under this agreement by the end of 2015. The termination of the agreement had no impact on the Company’s financial statements. Eisai In April 2011, the Company entered into a collaboration and license agreement with Eisai, under which the Company granted Eisai an exclusive worldwide license to its small molecule HMT inhibitors directed to the EZH2 HMT, including the Company’s product candidate tazemetostat, while retaining an opt-in right to co-develop, co-commercialize and share profits with Eisai as to licensed products in the United States. As of December 31, 2014, the Company had completed its performance obligations under the original agreement. In March 2015, the Company entered into an amended and restated collaboration and license agreement with Eisai (the “Eisai License Agreement”), under which the Company reacquired worldwide rights, excluding Japan, to its EZH2 program, including tazemetostat. Under the Eisai License Agreement, the Company is responsible for global development, manufacturing and commercialization outside of Japan of tazemetostat and any other EZH2 product candidates, with Eisai retaining development and commercialization rights in Japan, as well as a right to elect to manufacture tazemetostat and any other EZH2 product candidates in Japan, and a right of first negotiation for the rest of Asia. Eisai waived its right of first negotiation for the rest of Asia in 2018. Under the original collaboration and license agreement, Eisai was solely responsible for funding all research, development and commercialization costs for EZH2 compounds. Under the Eisai License Agreement, the Company is solely responsible for funding global development, manufacturing and commercialization costs for EZH2 compounds outside of Japan, including the remaining development costs due under a companion diagnostics agreement with Roche Molecular Systems, Inc., or Roche Molecular, which was amended to assign all of Roche Molecular’s rights and obligations under the companion diagnostics agreement to Roche Sequencing, effective January 1, 2020. Eisai is solely responsible for funding Japan-specific development and commercialization costs for EZH2 compounds. The Company recorded the reacquisition of worldwide rights, excluding Japan, to the EZH2 program, including tazemetostat, under the Eisai License Agreement, as an acquisition of an in-process research and development asset. As this asset was acquired without corresponding processes or activities that would constitute a business, had not achieved regulatory approval for marketing and, absent obtaining such approval, had no alternative future use, the Company recorded the $ 40.0 million upfront payment made to Eisai in March 2015 as research and development expense in the consolidated statements of operations and comprehensive loss. The Company also agreed to pay Eisai up to $ 70.0 million in clinical development and regulatory milestones, all of which have been paid, and royalties at a percentage in the mid-teens on worldwide net sales of any EZH2 product, excluding net sales in Japan. The Company is eligible to receive from Eisai royalties at a percentage in the mid-teens on net sales of any EZH2 product in Japan. During the years ended December 31, 2020 and 2019, Eisai purchased drug product from the Company at cost to facilitate development within Japan under the Eisai License Agreement and the Company recognized approximately $ 5.3 million and $ 3.8 million, respectively, as a reduction to research and development expense. During the years ended December 31, 2021 and 2020, the Company recorded $ 4.6 million and $ 1.7 million, respectively related to worldwide royalties due under the Eisai License Agreement in cost of product revenue based on U.S. sales of TAZVERIK and as of December 31, 2021 and 2020, $ 1.7 million and $ 0.7 million, respectively in royalties were payable under the Eisai License Agreement. As of December 31, 2021, and 2020, the Company had accounts receivable of less than $ 0.1 million, respectively, due from Eisai. F or additional information regarding certain of the Eisai royalties, see Note 12, Sale of Future Royalties . In March 2021, the Company and Eisai entered into a supply agreement providing for the manufacture and supply to Eisai of tazemetostat drug product. Under the terms of the supply agreement, the Company also agreed to waive its right of exclusive supply of tazemetostat drug substance from the Company’s drug substance manufacturer. During the year ended December 31, 2021, the Company recognized $ 6.3 million related to the Company’s waiver of its exclusive right to supply of tazemetostat drug substance from the Company’s drug substance manufacturer and delivery of tazemetostat drug product in collaboration and other revenue. Roche In December 2012, Eisai and the Company entered into a companion diagnostics agreement with Roche Molecular, under which Eisai and the Company engaged Roche Molecular to develop a companion diagnostic to identify patients who possess certain activating mutations of EZH2. In October 2013, this agreement was amended to include additional mutations in EZH2. The development costs due under the amended agreement with Roche Molecular were the responsibility of Eisai until the execution of the amended and restated collaboration and license agreement with Eisai in March 2015, at which time the Company assumed responsibility for the remaining development costs due under the agreement. In December 2015, the Company and Eisai entered into a second amendment to the companion diagnostics agreement with Roche Molecular. The agreement was further amended in March 2018. Under the amended agreement, the Company was responsible for remaining development costs of $ 10.4 million due under the agreement as of March 2018 and Eisai agreed to reimburse the Company $ 0.9 million of this amount related to a regulatory milestone for Japan. In July 2019, the Company entered into a fourth amendment to the companion diagnostics agreement. Under the amended agreement, the Company and Roche Molecular agreed to divide a $ 1.0 million regulatory milestone for the United States into two separate milestone payments, of which $ 0.5 million was paid by the Company as part of the signed amendment, and the remaining $ 0.5 million was paid by the Company in December 2019 upon the satisfaction of certain conditions set forth in the fourth amendment to the companion diagnostics agreement. As part of this fourth amendment, Roche Molecular also assigned all of its rights and obligations under the companion diagnostics agreement to Roche Sequencing due to a reorganization at Roche group, and this assignment became effective as of January 1, 2020. As of December 31, 2021, the Company is responsible for the remaining development costs of $ 1.0 million due under the agreement. The $ 0.9 million that Eisai agreed to reimburse the Company related to a regulatory milestone for Japan was achieved as of June 30, 2020 and payment received in the fourth quarter of 2020. In addition, the Company paid $ 1.0 million for the achievement of a development milestone in the fourth quarter of 2020. Under the agreement with Roche Sequencing, Roche Sequencing is obligated to use commercially reasonable efforts to develop and to make commercially available the companion diagnostic. Roche Sequencing has exclusive rights to commercialize the companion diagnostic. On June 18, 2020 the FDA approved the companion diagnostic that is intended to identify follicular lymphoma patients with an EZH2 mutation for treatment with tazemetostat. The agreement with Roche Sequencing will expire when the Company and Eisai are no longer developing or commercializing tazemetostat. The Company and Eisai may terminate the agreement by giving Roche Sequencing 90 days’ written notice if the Company and Eisai discontinue development and commercialization of tazemetostat or determine, in conjunction with Roche Sequencing, that the companion diagnostic is not needed for use with tazemetostat. Any party may also terminate the agreement in the event of a material breach by any party, in the event of material changes in circumstances that are contrary to key assumptions specified in the agreement or in the event of specified bankruptcy or similar circumstances. Under specified termination circumstances, Roche Sequencing may become entitled to specified termination fees. Boehringer Ingelheim In November 2018, the Company entered into a collaboration and license agreement with Boehringer Ingelheim International GmbH (“Boehringer Ingelheim”) to discover, research, develop and commercialize small molecule compounds that are inhibitors of an undisclosed histone acetyltransferase, or HAT, target and an undisclosed helicase target, along with associated predictive biomarkers (the “Target Projects”). Under the terms of the agreement, the Company granted to Boehringer Ingelheim an exclusive, worldwide license to the undisclosed target inhibitors technology. The agreement also included reciprocal licenses to utilize each other’s know-how, patents and technologies for activities under the agreement. Further, each party was granted the license to develop, manufacture, commercialize and otherwise exploit any compound or product that successfully achieves start of lead optimization (“SoLO”). The Company was also obligated to provide R&D services through SoLO approval for both Target Projects, and to serve on the Joint Steering Committee (“JSC”) throughout the term of the contract. The parties were to jointly research and develop the shared helicase target program and will share commercialization activities within the United States. Boehringer Ingelheim had agreed to assume responsibility for commercialization outside of the United States. On December 21, 2020, the Company received written notice from Boehringer Ingelheim that it elected to terminate the Collaboration Agreement without cause, and in accordance with the terms of the Collaboration Agreement. The termination became effective on January 31, 2021. The Target Project for the helicase target and the reciprocal licenses terminated as of this date. The Company is entitled to pursue the HAT target and helicase target programs in all fields worldwide without further obligation to Boehringer Ingelheim. Agreement Structure Under the terms of the agreement, the Company received a $ 15.0 million upfront payment and $ 5.0 million in research funding for the costs to be incurred by the Company in connection with its research activities, payable quarterly in four equal installments during 2019. At its discretion, Boehringer Ingelheim had the option to extend the research period by up to one year , subject to the Company’s agreement to the specified research activities and additional research funding. During the third quarter of 2019, Boehringer Ingelheim’s option to extend the research period expired unexercised, and therefore the research period ended on December 31, 2019. In March 2020, the Company and Boehringer Ingelheim amended the agreement to extend the research period for the shared program targeting enzymes within helicase families with Boehringer Ingelheim providing research funding of $ 0.4 million. Additionally, in March 2020, the Company received notice of termination for the program targeting enzymes with HAT families, which program termination became effective in June 2020. In September 2020, the Company and Boehringer Ingelheim further amended the agreement to extend the research period for the shared program targeting enzymes within helicase families with Boehringer Ingelheim to provide research funding of $ 0.1 million. The additional research activities were completed prior to the end of 2020. Collaboration Revenue Through December 31, 2021, the Company has recognized $ 26.0 million in total collaboration revenue since the inception of this collaboration. During the years ended December 31, 2021, 2020 and 2019, the Company recognized revenue of $ 0 , $ 0.5 million and $ 23.8 million, respectively. The Company will no t receive any additional revenue under the terms of its agreement with Boehringer Ingelheim. |
Sale of Future Royalties
Sale of Future Royalties | 12 Months Ended |
Dec. 31, 2021 | |
Deferred Revenue Disclosure [Abstract] | |
Sale of Future Royalties | 12. Sale of Future Royalties On November 4, 2019, the Company entered into a loan agreement with BioPharma Credit PLC, or the Collateral Agent, and the Lenders , providing for up to $ 70.0 million in secured term loans to be advanced in up to three tranches, or the Loan Agreement. As of December 31, 2020, the Company had borrowed an aggregate principal amount under the first tranche of $ 25.0 million (the “Tranche A Note Payable”), the second tranche of $ 25.0 million (the “Tranche B Note Payable”), and the third tranche of $ 20.0 million (the “Tranche C Note Payable”) under the Loan Agreement. On November 3, 2020, the Company, the Collateral Agent and the Lenders amended and restated the Loan Agreement, (as amended and restated, the “Amended and Restated Loan Agreement”), to provide for, among other things, an additional secured term loan of $ 150.0 million, or the Tranche D Loan. On November 18, 2020, the Company borrowed the Tranche D Loan (See Note 13, Long-Term Debt ). On November 4, 2019, the Company also executed a purchase agreement (the “RPI Purchase Agreement”) with RPI. Pursuant to the RPI Purchase Agreement, the Company agreed to sell to RPI 6,666,667 shares of its common stock, a warrant to purchase up to 2,500,000 shares of common stock at an exercise price of $ 20.00 per share (the “Common Stock Warrant”), and all of the Company’s rights to receive royalties from Eisai with respect to net sales by Eisai of tazemetostat products in Japan pursuant to the Eisai License Agreement and any successor arrangement for Japan sales (the “Japan Royalty”, and collectively, the “Transaction”). In consideration for the sale of shares of common stock, the Common Stock Warrant and the Japan Royalty, RPI paid the Company $ 100.0 million upon the closing of the RPI Purchase Agreement. In addition, RPI agreed, in connection with RPI’s acquisition from Eisai of the right to receive royalties from the Company under the Eisai License Agreement, to reduce the Company’s royalty obligation by low single digits upon the achievement of specified annual net sales levels over $ 1.5 billion. In addition, under the RPI Purchase Agreement, the Company had the right to sell, and RPI had the obligation to purchase, subject to certain conditions, including a maximum purchase price of $ 20.00 per share, $ 50.0 million of shares of common stock at the Company’s option for an 18-month period from the date of execution of the RPI Purchase Agreement (the “Put Option”). In February 2020, the Company sold 2.5 million shares of its common stock to RPI, for an aggregate of $ 50.0 million in proceeds pursuant to the Put Option. Additionally, under the terms of the RPI Purchase Agreement, the founder and chief executive officer of RP Management, an affiliate of RPI, and a co-founder of Pharmakon Advisors LP, an affiliate of the Lenders was elected as a director of the Company. As of December 31, 2021 and 2020 , RPI and its affiliates owned approximately 8.6 % and 9.0 % of the Company’s common stock, respectively. The Company accounted for the Loan Agreement and RPI Purchase Agreement as a single arrangement as RPI and the Lenders are related parties and the agreements were negotiated together. The aggregate proceeds of $ 125.0 million were allocated on a relative fair value basis, which approximated their respective actual fair values, to the four units of accounting pursuant to the transaction as follows: (1) $ 79.0 million to the common stock issued to RPI based on the closing price of the Company’s common stock on the date of the transaction, (2) $ 8.4 million to the Common Stock Warrant to purchase shares of common stock, based on the Black-Scholes option pricing model, (3) $ 12.6 million to the liability related to the sale of future royalties based on a discounted cash flow model and (4) $ 25.0 million to the Tranche A Note Payable based on the terms of the Loan Agreement. Transaction costs of $ 2.0 million were allocated directly to the units of accounting it relates to. Although the Company sold all of its rights to receive the Japan Royalty, under the terms of the RPI Agreement, the Company continues to own all tazemetostat intellectual property rights and at execution had significant continuing involvement in the generation of these royalties. Due to the Company’s continuing involvement, the Company will continue to account for any royalties due as revenue and recorded the proceeds from this transaction as a liability (“Royalty Obligation”) that will be accreted using the effective interest method over the estimated life of the RPI Purchase Agreement. As royalties are remitted to RPI from Eisai, the balance of the Royalty Obligation will be effectively repaid over the life of the Eisai License Agreement. In order to determine the accretion of the Royalty Obligation, the Company is required to estimate the total amount of future royalty payments to RPI over the life of the Eisai License Agreement. The $ 12.6 million recorded at execution will be accreted to the total of these royalty payments as interest expense over the life of the Royalty Obligation. At execution, the Company’s estimate of this total interest expense resulted in an effective annual interest rate of approximately 9.01 %. This estimate contains significant assumptions that impact both the amount recorded at execution and the interest expense that will be recognized over the royalty period. The Company periodically assesses the estimated royalty payments to RPI from Eisai and to the extent the amount or timing of such payments is materially different than the original estimates, an adjustment is made to the effective interest rate, which will be recorded prospectively to increase or decrease interest expense. There are a number of factors that could materially affect the amount and timing of royalty payments to RPI from Eisai, and correspondingly, the amount of interest expense recorded by the Company, most of which are not within the Company’s control. Such factors include, but are not limited to, delays or discontinuation of development of tazemetostat in Japan, regulatory approval, changing standards of care, the introduction of competing products, manufacturing or other delays, generic competition, intellectual property matters, adverse events that result in governmental health authority imposed restrictions on the use of the drug products, significant changes in foreign exchange rates as the royalties remitted to RPI are made in U.S. dollars (USD) while the underlying Japan sales of tazemetostat will be made in currencies other than USD, and other events or circumstances that are not currently foreseen as tazemetostat is still under development in Japan and subject to regulatory approval. Changes to any of these factors could result in increases or decreases to both royalty revenues and interest expense. On June 23, 2021, Eisai announced that it had obtained manufacturing and marketing approval for the EZH2 inhibitor “Tazverik® Tablets 200 mg” (tazemetostat hydrobromide) in Japan with the indication of relapsed or refractory EZH2 gene mutation-positive follicular lymphoma (only when standard treatment is not applicable), which caused the Company to reassess the estimated future royalty payments to RPI. As of December 31, 2021 , the Company’s assessment of the estimated future royalty payments to RPI resulted in a current effective interest rate of approximately 9 .19 %. The following table shows the activity of the Royalty Obligation since the transaction inception through December 31, 2021: Year Ended (In thousands ) Proceeds from sale of future royalties $ 12,601 Non-cash royalty revenue ( 31 ) Non-cash interest expense recognized 3,357 Liability related to the sale of future royalties - ending balance 15,927 Less current portion ( 273 ) Related party liability related to sale of future royalties, net of current portion $ 15,654 During the year ended December 31, 2021 , the Company recorded non-cash royalties from net sales of tazemetostat in Japan of less than $ 0.1 million. During the years ended December 31, 2020 and 2019 , the Company did no t record non-cash royalties from net sales of tazemetostat in Japan. During the years ended December 31, 2021, 2020 and 2019 the Company recorded $ 1.8 million, $ 1.4 million and $ 0.2 million, respectively, of related non-cash interest expense. |
Long-Term Debt
Long-Term Debt | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
Long-Term Debt | 13. Long-Term Debt On November 4, 2019, the Company entered into the Loan Agreement, which provided for up to $ 70.0 million in secured term loans to be advanced in up to three tranches. The Company borrowed $70.0 million in the aggregate under the three tranches pursuant to the Loan Agreement. With the FDA’s June 2020 approval of tazemetostat for the treatment of FL in the United States, the Company also had the right, but not the obligation, to request up to an additional $ 300.0 million in secured term loans, subject to the approval of the Lenders, provided the Company has not prepaid any outstanding term loans at the time of such request and such request is made before November 18, 2021. On November 3, 2020, the Company entered into the Amended and Restated Loan Agreement with the Lenders. The Amended and Restated Loan Agreement provides for, among other things, an additional secured term loan of $ 150.0 million, or the Tranche D Loan. On November 3, 2020, the Company also delivered written notice to the Lenders to draw down the Tranche D Loan, which was funded on November 18, 2020. The Company paid a commitment fee of 2.00 % of the original $ 70.0 million committed facility amount in November 2019 and 2 % of the $ 150.0 million Tranche D Loan in November 2020, as well as expenses incurred by the Lender in executing the agreements. The interest rate for the Tranche D Loan will be determined by reference to a Eurodollar rate plus 7.75 % above such Eurodollar rate. The Eurodollar rate will have a 2.00 % floor. The Tranche D Loan will be due in eight equal quarterly principal payments commencing on the 51st month anniversary of the date on which the Lenders fund the Tranche D Loan. All unpaid principal and interest under the Tranche D Loan will be due and payable on the 72nd month anniversary of the date on which the Lenders funded the Tranche D Loan. The Amended and Restated Loan Agreement also amended the payment period principal and interest for the first three tranches of term loans. Under the original terms, the Company was required to make interest only payments on the outstanding obligation through February 28, 2023, and thereafter eight quarterly payments of principal and interest. Under the amended and restated terms, the Company is required to make interest only payments on the $ 70.0 million outstanding obligation through November 2023, and thereafter four quarterly payments of principal and interest. All unpaid principal and interest on the $ 70.0 million borrowed under the original Loan Agreement is due and payable in November 2024, the 60th month anniversary of the date on which the Lenders funded the first tranche of term loans. The interest rates for the existing tranches of term loans remain unchanged and will continue to be determined by reference to a Eurodollar rate plus 7.75% above such Eurodollar rate. The Eurodollar rate will have a 2.00% floor. Each of the four term loans may be prepaid before maturity in whole or in part, however there is a $ 50.0 million minimum prepayment for any prepayment of the loans. If the Company prepays any tranche of term loans, in whole or in part, during the first 36 months from the date on which the Lenders funded such tranche of term loans, then the Company must pay a prepayment premium equal to the greater of (x) a make-whole amount equal to the interest that would have accrued on the principal amount to be prepaid and (y) a premium equal to 0.03 multiplied by the principal amount to be prepaid. If the Company prepays a tranche of term loan, in whole or in part, between the 36th month and 48th month from the date on which the Lenders funded such tranche of term loans, then the Company must pay a prepayment premium equal to 0.02 multiplied by the principal amount to be prepaid. If the Company prepays a tranche of term loans, in whole or in part, between the 48th month and 60th month from the date on which the Lenders funded such tranche of term loans, then the Company must pay a prepayment premium equal to 0.01 multiplied by the principal amount to be prepaid. The Amended and Restated Loan Agreement was accounted for as a debt modification based on a comparison of the present value of the cash flows under the terms of the debt immediately before and after the effective date of The Amended and Restated Loan Agreement, which resulted in a change of less than 10%. As a result, issuance costs paid to the Lenders in connection with The Amended and Restated Loan Agreement were recorded as a reduction of the carrying amount of the debt liability and unamortized issuance costs as of the date of the modification are amortized to interest expense over the repayment term of The Amended and Restated Loan Agreement. The obligations under the Amended and Restated Loan Agreement, including the Company’s payment obligations in respect of the Tranche D Loan are secured by the first priority security interest in and a lien on substantially all of the assets of the Company, subject to certain exceptions, that the Company granted to the Lenders in connection with the first tranche of term loans under the Loan Agreement. The Amended and Restated Loan Agreement contains certain customary representations and warranties, affirmative and negative covenants and events of default applicable to the Company and its subsidiaries. If an event of default occurs and is continuing, the Collateral Agent may, among other things, accelerate the loans and foreclose on the collateral. The Company has determined that the risk of subjective acceleration under the material adverse events clause is not probable and therefore has classified the outstanding principal in non-current liabilities based on scheduled principal payments. The Company has the following minimum aggregate future loan payments at December 31, 2021 (in thousands): Year Ended 2022 — 2023 — 2024 70,000 2025 75,000 2026 75,000 Total minimum payments 220,000 Less amounts representing interest and discount ( 3,539 ) Less current portion — Related party long-term debt, net of debt discount $ 216,461 For the years ended December 31, 2021, 2020 and 2019 , interest expense related to the Company's Amended and Restated Loan Agreement was approximately $ 22.5 million, $ 7.2 million and $ 0.3 million, respectively. The total carrying value of debt is classified as long-term on the Company's consolidated balance sheet as of December 31, 2021 and 2020 , respectively. |
Stockholders' Equity (Deficit)
Stockholders' Equity (Deficit) | 12 Months Ended |
Dec. 31, 2021 | |
Equity [Abstract] | |
Stockholders' Equity (Deficit) | 14. Stockholders’ Equity (Deficit) Common Stock On March 24, 2020, the Company’s board of directors adopted, subject to stockholder approval, an amendment to the Company’s Restated Certificate of Incorporation to increase the number of authorized shares of common stock, $ 0.0001 par value per share, from 125,000,000 to 150,000,000 (the “Charter Amendment”). At the Company’s 2020 Annual Meeting of Stockholders, the stockholders of the Company approved the Charter Amendment, which was filed with the Secretary of State of the State of Delaware on May 29, 2020. On April 8, 2021, the Company’s board of directors adopted, subject to stockholder approval, an amendment to the Company’s Restated Certificate of Incorporation to increase the number of authorized shares of common stock from 150,000,000 to 225,000,000 (the "2021 Charter Amendment"). At the Company’s 2021 Annual Meeting of Stockholders, the stockholders of the Company approved the 2021 Charter Amendment, which was filed with the Secretary of State of the State of Delaware on June 11, 2021. The number of authorized shares of preferred stock was not affected by these Charter Amendments. Each share of common stock entitles the holder to one vote on all matters submitted to a vote of the Company’s stockholders. Common stockholders are entitled to dividends when and if declared by the board of directors. 2021 At-the-Market Offering Program On May 6, 2021, the Company entered into an Open Market Sale Agreement SM (“ATM Sale Agreement”), with Jefferies LLC (“Jefferies”) to sell, from time to time, shares of the Company's common stock having an aggregate offering price of up to $ 200.0 million through an “at the market offering” as defined in Rule 415 under the Securities Act of 1933, as amended, under which Jefferies would act as sales agent (the "ATM Offering"). The shares that may be sold under the ATM Sale Agreement, if any, are issued and sold pursuant to the Company’s shelf registration statement on Form S-3 that was declared effective by the Securities and Exchange Commission on May 13, 2021. The Company agreed to compensate Jefferies at a fixed commission rate equal to 3.0 % of the gross sales proceeds of such shares. From the initiation of the ATM Offering through December 31, 2021 , the Company has issued and sold 3,840,977 shares under the ATM Offering, resulting in aggregate net proceeds of $ 16.0 million after deducting issuance costs of $ 0.5 million. RPI Put Option In February 2020, the Company sold 2,500,000 shares of its common stock in connection with the exercise of its Put Option to sell shares of its common stock for an aggregate of $ 49.9 million in net proceeds after deducting financing costs of $ 0.1 million. (see Note 12, Sale of Future Royalties ). Convertible Preferred Stock The Company has 337,800 shares of Series A Convertible Preferred Stock outstanding as of December 31, 2021 and 2020. Voting Rights Shares of Series A Preferred Stock will generally have no voting rights except as required by law and except that the consent of the holders of a majority of the outstanding shares of Series A Preferred Stock will be required to amend the terms of the Series A Preferred Stock or take certain other actions with respect to the Series A Preferred Stock. Dividends Shares of Series A Preferred Stock will be entitled to receive dividends equal to (on an as-if-converted-to-common stock basis), and in the same form and manner as, dividends actually paid on shares of the Company’s common stock. Liquidation Rights Subject to the prior and superior rights of the holders of any senior securities of the Company, upon liquidation, dissolution or winding up of the Company, whether voluntary or involuntary, each holder of shares of Series A Preferred Stock shall be entitled to receive, in preference to any distributions of any of the assets or surplus funds of the Company to the holders of common stock, an amount equal to $ 0.001 per share of Series A Preferred Stock, plus an additional amount equal to any dividends declared but unpaid on such shares, before any payments shall be made or any assets distributed to holders of any class of common stock. If, upon any such liquidation, dissolution or winding up of the Company, the assets of the Company shall be insufficient to pay the holders of shares of the Series A Preferred Stock the amount required under the preceding sentence, then all remaining assets of the Company shall be distributed ratably to holders of the shares of the Series A Preferred Stock in proportion to the respective amounts which would otherwise be payable in respect of the shares held by them upon such distribution if all amounts payable on or with respect to such shares were paid in full. Conversion Each share of Series A Preferred Stock shall be convertible, at any time and from time to time from and after the issuance date, at the option of the holder thereof, into a number of shares of common stock equal to 10 shares of common stock, provided that the holder will be prohibited from converting Series A Preferred Stock into shares of the Company’s common stock if, as a result of such conversion, the holder, together with its affiliates and attribution parties, would own more than 9.99 % of the total number of shares of common stock then issued and outstanding. The holder can change this requirement to a higher or lower percentage, not to exceed 9.99% of the number of shares of common stock outstanding, upon 61 days’ notice to the Company. In February 2020, 12,200 shares of Series A Preferred Stock were converted to 122,000 shares of common stock. Redemption The Company is not obligated to redeem or repurchase any shares of Series A Preferred Stock. Shares of Series A Preferred Stock are not entitled to any redemption rights or mandatory sinking fund or analogous fund provisions. Warrants In November 2019, the Company issued the Common Stock Warrant for the purchase of up to 2,500,000 shares of Common Stock at an exercise price of $ 20.00 per share to RPI pursuant to the RPI Purchase Agreement (for additional information see Note 12, Sale of Future Royalties ), which was classified as equity and recorded at its relative fair value of $ 8.4 million to additional paid-in-capital on the Company's consolidated balance sheets. The Common Stock Warrant remains outstanding as of December 31, 2021. In August 2021, the Company issued the HutchMed Warrant to HutchMed under the HutchMed License Agreement, exercisable at any time prior to August 7, 2025 for up to 5,653,000 shares of the Company’s common stock at an exercise price of $ 11.50 per share. Under the HutchMed Warrant, the number of shares issuable under the warrant is reduced from 5,653,000 to 2,826,500 in the event that the HutchMed License Agreement is terminated for certain reasons as more fully described in the HutchMed License Agreement. Due to this provision, the Company concluded that the warrant does not meet the exception from derivative accounting pursuant to ASC 815, Derivatives and Hedging, which requires that the warrant be accounted for as a derivative. Accordingly, the Company recorded a warrant liability in the amount of approximately $ 13.0 million upon issuance. The fair value of the HutchMed Warrant was determined using a Black-Scholes and Monte Carlo pricing model. The HutchMed Warrant is subject to revaluation at each balance sheet date and any changes in fair value are recorded as a non-cash gain or (loss) in the Company's consolidated statement of operations and comprehensive loss as a component of other income (expense), net until the earlier of the exercise or expiration of the HutchMed Warrant or upon the completion of a liquidation event. The Company recorded non-cash gains of approximately $ 11.1 million during 2021 in its consolidated statement of operations and comprehensive loss attributable to the decreases in the fair value of the warrant liability that resulted from a reduction in the Company's stock price as of December 31, 2021. The following table rolls forward the fair value of the HutchMed Warrant liability, the fair value of which is determined by Level 3 inputs at inception on August 7, 2021, and as of December 31, 2021: (In thousands) Fair value at inception $ 13,050 Decrease in fair value ( 11,120 ) Fair value at December 31, 2021 $ 1,930 The key assumptions used to value the HutchMed Warrant were as follows: Inception As of December 31, 2021 Risk-free interest rate 0.6 % 1.05 % Expected term (in years) 4.0 years 3.6 years Expected volatility of underlying stock 70.0 % 70.0 % Expected dividend yield - - Stock price $ 6.47 $ 2.50 |
Employee Benefit Plans
Employee Benefit Plans | 12 Months Ended |
Dec. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Employee Benefit Plans | 15. Employee B enefit Plans Stock Incentive Plans The Company maintains one stock incentive plan, the 2013 Stock Incentive Plan, as well as the 2013 Employee Stock Purchase Plan. In addition, during the year ended December 31, 2021, the Company granted options to purchase an aggregate of 248,366 shares of Epizyme common stock and 106,955 restricted stock units (RSUs) to four new employees as equity inducement awards outside of the Company's 2013 Stock Incentive Plan and material to the employees’ acceptance of employment with the Company. These equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4), and these equity awards remained outstanding as of December 31, 2021. The options have a weighted average exercise price of $ 5.12 per share, and the RSUs have a weighted average grant date fair value of $ 5.08 per unit. These inducement awards are included in stock-based compensation expense and the following tables. Stock-Based Compensation Expense Stock-based compensation expense is classified in the consolidated statements of operations and comprehensive loss as follows: Year Ended December 31, 2021 2020 2019 (In thousands) Research and development $ 8,360 $ 9,093 $ 6,295 General and administrative 18,427 18,516 11,721 Total $ 26,787 $ 27,609 $ 18,016 Stock Options The weighted-average grant date fair value of options, estimated as of the grant date using the Black-Scholes option-pricing model. Weighted average assumptions used in this pricing model on the date of grant for options granted to employees are as follows: Year Ended December 31, 2021 2020 2019 Risk-free interest rate 0.7 % 0.9 % 2.2 % Expected life of options 5.89 years 5.99 years 6.0 years Expected volatility of underlying stock 70.0 % 70.9 % 72.0 % Expected dividend yield 0.0 % 0.0 % 0.0 % The following is a summary of stock option activity for the year ended December 31, 2021: Number of Weighted Weighted Aggregate (In thousands) (In years) (In thousands) Outstanding at December 31, 2020 10,225 $ 14.77 Granted 6,422 7.81 Exercised ( 104 ) 8.83 Forfeited or expired ( 3,597 ) 13.88 Outstanding at December 31, 2021 12,946 $ 11.61 7.62 $ - Exercisable at December 31, 2021 5,463 $ 14.39 5.82 $ - During the years ended December 31, 2021, 2020 and 2019, the Company granted stock options to purchase an aggregate of 6,421,792 shares, 3,522,258 shares, and 4,222,693 shares, respectively, at weighted-average grant date fair values per option share of $ 4.79 , $ 11.69 , and $ 6.99 , respectively. The total grant date fair value of options that vested during the years ended December 31, 2021, 2020 and 2019 was $ 27.2 million, $ 17.4 million, and $ 13.2 million, respectively. The aggregate intrinsic value of stock options exercised was $ 0.1 million in 2021, $ 5.5 million in 2020 and $ 1.2 million in 2019. As of December 31, 2021, there was $ 37.3 million in unrecognized stock-based compensation related to stock options that are expected to vest. These costs are expected to be recognized over a weighted average remaining vesting period of 2.3 years. Restricted Stock Units During the year-ended December 31, 2021 , 2,240,217 restricted stock units (“RSUs”) were granted to executives and employees and 105,944 RSUs were granted to non-employee directors. The awards were service-based. Assuming all service conditions are achieved, the executive and employee RSUs will vest as to 50 %, 33 %, and 25 %, respectively, of the shares of Company common stock underlying the RSUs on an annual basis over two , three , or four year period of time from the grant dates, respectively, and the non-employee director RSUs will vest as to 100 % of the shares of Company common stock underlying the RSUs in full on the earlier of the first anniversary of the grant date and the date of the succeeding annual meeting of stockholders. Number of Weighted (In thousands except per share data) Outstanding at December 31, 2020 668 $ 17.56 Granted 2,346 7.74 Vested ( 187 ) 17.20 Forfeited ( 605 ) 12.15 Outstanding at December 31, 2021 2,222 $ 8.70 Compensation expense totaling $ 4.9 million, $ 2.7 million, and $ 0.5 million was recognized for the service-based RSUs for the years-ended December 31, 2021, 2020 and 2019, respectively. As of December 31, 2021 , there was $ 14.3 million of unrecognized compensation cost related to service-based RSUs that are expected to vest. These costs are expected to be recognized over a weighted average remaining vesting period of 2.2 years. During 2019, the Company granted 604,000 RSUs to executives and employees, which contained performance conditions, 20 % of the RSUs vested on June 30, 2019, 25 % of the RSUs vested on January 23, 2020, 20 % of the RSUs vested on March 24, 2020, and 30 % of the RSUs vested on June 25, 2020 in connection with achievement of the final performance milestone. Compensation expense totaling $ 3.5 million and $ 3.6 million was recognized for the performance-based RSUs for the years-ended December 31, 2020 and 2019, respectively. There was no unrecognized compensation cost as of December 31, 2020, related to performance-based RSUs, as all of the performance conditions have been achieved. 401(k) Savings Plan The Company has a defined contribution 401(k) savings plan (the “401(k) Plan”). The 401(k) Plan covers substantially all employees, and allows participants to defer a portion of their annual compensation on a pretax basis. Company contributions to the 401(k) Plan may be made at the discretion of the board of directors. During the year ended December 31, 2014, the Company implemented a matching contribution to the 401(k) Plan, matching 50 % of an employee’s contribution up to a maximum of 3 % of the participant’s compensation. Company contributions to the 401(k) plan totaled $ 1.4 million, $ 1.2 million and $ 0.6 million in the years ended December 31, 2021, 2020 and 2019 , respectively. |
Loss per Share
Loss per Share | 12 Months Ended |
Dec. 31, 2021 | |
Earnings Per Share [Abstract] | |
Loss per Share | 16. Loss p er Share As described in Note 2, Summary of Significant Accounting Policies , the Company computes basic and diluted earnings (loss) per share using a methodology that gives effect to the impact of outstanding participating securities (the “two-class method”). The two-class method was not applied for the years ended December 31, 2021, 2020, and 2019 due to the net loss recognized in each of those periods. In 2019 the net loss applicable to common stockholders did not equal net loss due to the accretion of the beneficial conversion feature of Series A Preferred Stock in the amount of $ 2.9 million. The beneficial conversion feature was initially recorded as a discount on the Series A Preferred Stock with a corresponding amount recorded to Additional Paid-in Capital. The discount on the Series A Preferred Stock was then immediately written off as a deemed dividend as the Series A Preferred Stock does not have a stated redemption date and is immediately convertible at the option of the holder. Basic and diluted loss per share allocable to common stockholders are computed as follows: Year Ended December 31, 2021 2020 2019 (In thousands except per share data) Net loss $ ( 251,122 ) $ ( 231,694 ) $ ( 170,295 ) Accretion of Series A Preferred Stock — — ( 2,940 ) Net loss attributable to common stockholders $ ( 251,122 ) $ ( 231,694 ) $ ( 173,235 ) Weighted average shares outstanding 102,646 100,960 89,891 Basic and diluted loss per share allocable to common stockholders $ ( 2.45 ) $ ( 2.29 ) $ ( 1.93 ) The following common stock equivalents were excluded from the calculation of diluted loss per share allocable to common stockholders because their inclusion would have been anti-dilutive: Year Ended December 31, 2021 2020 2019 (In thousands) Stock options 12,946 10,225 8,087 Restricted stock units 2,222 669 757 Shares issuable under employee stock purchase plan 155 98 38 Series A Preferred Stock (if converted) 3,378 3,378 3,500 Warrants 8,153 2,500 2,500 26,854 16,870 14,882 For the year ended December 31, 2019, the above table does not include the up to 6,250,000 shares subject to the Company’s option to sell additional shares to RPI pursuant to the Put Option as the decision to exercise this option was within the Company’s control. On December 30, 2019, the Company exercised its option to sell 2,500,000 shares of Common Stock to RPI for an aggregate of $ 50.0 million. The sale was effected on February 11, 2020. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2021 | |
Subsequent Events [Abstract] | |
Subsequent Events | 17. Subsequent Events Common Stock Offering In January 2022, the Company raised approximately $ 79.5 million in net proceeds (after deducting underwriting discounts and commissions and estimated offering costs, but excluding any expenses and other costs reimbursed by the underwriters) from the sale of 56,666,667 shares of its common stock in a public offering at a price of $ 1.50 per share. Operating Cost Reduction On March 1, 2022, the Company announced a cross-functional reduction of approximately 12 % of its current workforce under a cost reduction plan. Affected employees will be offered separation benefits, including severance payments along with temporary healthcare coverage assistance. The Company estimates that the severance and termination-related costs will be approximately $ 2.8 - 3.2 million and expects to record these charges in the first quarter of 2022. The Company expects that payments of these costs will be made through the end of the fourth quarter of 2022. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
Basis Of Presentation and Principles of Consolidation | Basis of Presentation and Principles of Consolidation The consolidated financial statements of the Company included herein have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission, or the SEC, and in accordance with U.S. generally accepted accounting principles, or GAAP. Any reference in these notes to applicable guidance is meant to refer to the authoritative accounting principles generally accepted in the United States as found in the ASC and Accounting Standards Update, or ASU, of the Financial Accounting Standards Board, or FASB. The consolidated financial statements include the accounts of Epizyme, Inc. and its wholly owned, controlled subsidiary, Epizyme Securities Corporation. All intercompany transactions and balances of subsidiaries have been eliminated in consolidation. |
Use of Estimates | Use of Estimates The preparation of these consolidated financial statements in accordance with accounting principles generally accepted in the United States requires management to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities, as of the date of the consolidated financial statements, and the reported amounts of revenue and expenses during the reporting period. Actual results and outcomes may differ materially from management’s estimates, judgments and assumptions. |
Subsequent Events | Subsequent Events The Company considers events or transactions that occur after the balance sheet date but before the consolidated financial statements are issued to provide additional evidence relative to certain estimates or to identify matters that require additional disclosure. The Company evaluated all events and transactions through the date these financial statements were filed with the Securities and Exchange Commission. |
Cash and cash equivalents | Cash and cash equivalents The Company considers all highly liquid securities with original final maturities of three months or less from the date of purchase to be cash equivalents. Cash and cash equivalents are comprised of demand deposit accounts, funds in money market accounts, commercial paper and corporate notes. |
Marketable securities | Marketable securities The Company classifies marketable securities with a remaining maturity when purchased of greater than three months as available-for-sale. The Company considers all available-for-sale securities, including those with maturity dates beyond 12 months, as available to support current operational liquidity needs and therefore classifies all securities with maturity dates beyond 90 days at the date of purchase as current assets. Available-for-sale securities are maintained by the Company’s investment managers and may consist of commercial paper, high-grade corporate notes, U.S. Treasury securities, and U.S. government agency securities. Available-for-sale securities are carried at fair value with the unrealized gains and losses included in other comprehensive loss as a component of stockholders’ equity until realized. Any premium or discount arising at purchase is amortized and/or accreted to interest income and/or expense over the life of the instrument. Realized gains and losses are determined using the specific identification method and are included in other income (expense). The aggregate fair value of securities held by the Company in an unrealized loss position for less than twelve months as of December 31, 2021 was $ 28.6 million, which consisted of 4 commercial paper securities and 6 U.S. Treasury securities. There were no marketable securities held by the Company for greater than twelve months as of December 31, 2021. The aggregate fair value of securities held by the Company in an unrealized loss position for less than twelve months as of December 31, 2020 was $ 67.7 million, which consisted of 6 commercial paper securities, 7 corporate notes securities and 1 U.S. Treasury security. There were no marketable securities held by the Company for greater than twelve months as of December 31, 2020. The Company does not intend to sell and it is unlikely that the Company will be required to sell the above investments before recovery of their amortized cost bases, which may be maturity. The Company determined there was no material change in the credit risk of the above investments, and as a result, the Company determined it did no t hold any investments with an other-than-temporary impairment as of December 31, 2021 and 2020. The Company reviews its portfolio of available-for-sale debt securities, using both quantitative and qualitative factors, to determine if declines in fair value below cost have resulted from a credit-related loss or other factors. If the decline in fair value is due to credit-related factors, a loss is recognized in net income, whereas if the decline in fair value is not due to credit-related factors, the loss is recorded in other comprehensive income (loss). The following table summarizes the available for sale securities held at December 31, 2021 (in thousands): Description Amortized Cost Unrealized Unrealized Fair Value Commercial paper $ 68,427 $ 7 $ ( 3 ) $ 68,431 Corporate notes — — — — U.S. government agency securities and U.S. Treasuries 10,025 — ( 1 ) 10,024 Total $ 78,452 $ 7 $ ( 4 ) $ 78,455 The following table summarizes the available for sale securities held at December 31, 2020 (in thousands): Description Amortized Cost Unrealized Unrealized Fair Value Commercial paper $ 158,907 $ 14 $ ( 8 ) $ 158,913 Corporate notes 33,437 3 ( 7 ) 33,433 U.S. government agency securities and U.S. Treasuries 13,044 1 — 13,045 Total $ 205,388 $ 18 $ ( 15 ) $ 205,391 Certain short-term debt securities with original maturities of less than 90 days are included in cash and cash equivalents within the consolidated balance sheets and are not included in the tables above. All marketable securities held at December 31, 2021 and December 31, 2020 have maturities of less than one year. The amortized cost of available-for-sale securities is adjusted for amortization of premiums and accretion of discounts to maturity. At December 31, 2021, the balance in the Company’s accumulated other comprehensive loss was composed mainly of activity related to the Company’s available-for-sale marketable securities. There were no realized gains or losses recognized on the sale or maturity of available-for-sale securities during the year ended December 31, 2021 and December 31, 2020 , respectively, and as a result, the Company did not reclassify any amounts out of accumulated other comprehensive loss for the same period. |
Restricted Cash | Restricted Cash A reconciliation of cash, cash equivalents, and restricted cash reported within the consolidated balance sheets that sum to the total of the same such amounts shown in the consolidated statements of cash flows, is as follows: December 31, 2021 2020 2019 (In thousands) Cash and cash equivalents $ 98,336 $ 168,215 $ 139,482 Restricted cash, as part of other assets 1,509 1,509 1509 Total cash, cash equivalents, and restricted cash shown in the consolidated statements of cash flows $ 99,845 $ 169,724 $ 140,991 The $ 1.5 million in restricted cash is comprised of $ 0.5 million in a letter of credit as a security deposit for the office and laboratory lease at Technology Square in Cambridge, Massachusetts and $ 1.0 million in a letter of credit as a security deposit for the Company’s office lease at Hampshire Street in Cambridge, Massachusetts. The Company has recorded cash held to secure these letters of credit as restricted cash in restricted cash and other assets on the consolidated balance sheet. The restricted cash is classified as non-current based on the related lease terms. |
Fair Value Measurements | Fair Value Measurements The FASB Codification Topic 820, Fair Value Measurements and Disclosures, requires the use of valuation techniques that are consistent with the market approach, the income approach and/or the cost approach. The market approach uses prices and other relevant information generated by market transactions involving identical or comparable assets and liabilities. The income approach uses valuation techniques to convert future amounts, such as cash flows or earnings, to a single present amount on a discounted basis. The cost approach is based on the amount that currently would be required to replace the service capacity of an asset (replacement cost). Valuation techniques should be consistently applied. GAAP also establishes a fair value hierarchy which requires an entity to maximize the use of observable inputs, where available, and minimize the use of unobservable inputs when measuring fair value. The standard describes three levels of inputs that may be used to measure fair value: Level 1 Quoted prices in active markets for identical assets or liabilities. Level 2 Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Level 3 Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. The Company’s financial instruments as of December 31, 2021 and 2020 consisted primarily of cash and cash equivalents, marketable securities and accounts receivable and accounts payable. As of December 31, 2021 and December 31, 2020, the Company’s financial assets recognized at fair value consisted of the following: Fair Value as of December 31, 2021 Total Level 1 Level 2 Level 3 (In thousands) Cash equivalents $ 88,637 $ 67,209 $ 21,428 $ — Marketable securities: Commercial paper 68,431 — 68,431 — Corporate notes — — — — U.S. government agency securities and treasuries 10,024 — 10,024 — Total $ 167,092 $ 67,209 $ 99,883 $ — Fair Value as of December 31, 2020 Total Level 1 Level 2 Level 3 (In thousands) Cash equivalents $ 163,264 $ 113,505 $ 49,759 $ — Marketable securities: Commercial paper 158,913 — 158,913 — Corporate notes 33,433 — 33,433 — U.S. government agency securities and treasuries 13,045 — 13,045 — Total $ 368,655 $ 113,505 $ 255,150 $ — Cash equivalents and marketable securities have been initially valued at the transaction price and subsequently valued, at the end of each reporting period, utilizing third-party pricing services or other market observable data. The Company measures its cash equivalents at fair value on a recurring basis, which approximates the net asset value per share. The Company classifies some of its cash equivalents within Level 1 of the fair value hierarchy because they are valued using observable inputs that reflect quoted prices for identical assets in active markets. The Company measures its marketable securities at fair value on a recurring basis and classifies those instruments and some cash equivalents within Level 2 of the fair value hierarchy. The pricing services used by management utilize industry standard valuation models, including both income and market-based approaches and observable market inputs to determine the fair value of marketable securities and those cash equivalents classified within Level 2 of the fair value hierarchy. As of December 31, 2021, the fair value of the long-term debt, payable in installments through November 18, 2026, approximated its carrying value due to the proximity of the issuance of the Tranche D Loan date to December 31, 2021 (See Note 13, Long-Term Debt ). |
Amortization of Debt Discount and Issuance Costs | Amortization of Debt Discount and Issuance Costs Long-term debt is initially recorded at its allocated proceeds, net of discounts and deferred costs. Debt discount and issuance costs, consisting of legal and other fees directly related to the debt, are offset against initial carrying value of the debt and are amortized to interest expense over the estimated life of the debt based on the effective interest method. |
Liability Related to Sale of Future Royalties | Liability Related to Sale of Future Royalties The Company treats the liability related to sale of future royalties as a debt financing, as the Company has significant continuing involvement in the generation of the cash flows, to be amortized to interest expense using the effective interest rate method over the life of the related royalty stream. The liability related to sale of future royalties and the related interest expense are based on the Company’s current estimates of future royalties expected to be paid over the life of the arrangement. The Company will periodically assess the expected royalty payments using a combination of internal projections and forecasts from external sources. To the extent the Company’s future estimates of royalty payments are greater or less than previous estimates or the estimated timing of such payments is materially different than its previous estimates, the Company will adjust its effective interest rate, which is applied prospectively. For further discussion of the sale of future royalties, refer to Note 12, Sale of Future Royalties . |
Going Concern | Going Concern At each reporting period, the Company evaluates whether there are conditions or events that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the financial statements are issued. The Company is required to make certain additional disclosures if it concludes substantial doubt exists about the Company's ability to continue as a going concern within one year after the date that the financial statements are issued and such doubt is not alleviated by the Company’s plans or when its plans alleviate substantial doubt about the Company’s ability to continue as a going concern. The Company’s evaluation entails analyzing prospective operating budgets and forecasts for expectations of the Company’s cash needs, and comparing those needs to its available cash, cash equivalents and marketable securities. The Company has recurring losses and expects to have recurring losses for the foreseeable future with the continued commercialization of TAZVERIK in ES and FL, the development of tazemetostat in other indications, and the development of the Company’s other product candidates. In addition, the Company has experienced and continues to experience challenges in the continued commercialization of TAZVERIK resulting from the ongoing COVID-19 pandemic, which the Company believes has had an adverse impact on TAZVERIK revenues. In response to the challenges that the Company has continued to face since the Company commenced its launch of TAZVERIK in FL in June 2020, the Company implemented an operational cost reduction plan that was announced on August 9, 2021 and continues to evaluate its costs on an on-going basis with the intent to streamline such costs. The analysis of the Company’s ability to continue as a going concern for the year ended December 31, 2021 included consideration of the Company’s current cash needs, including its research and development plans, commercialization activities associated with the continued commercialization of TAZVERIK in the ES and FL indications, its existing debt service obligations, and anticipated cost savings resulting from its operational cost reduction plan, including ongoing efforts to eliminate costs not related to the Company’s strategic focus. The analysis included forecasted product revenues from sales of TAZVERIK. Such estimates of future sales contain significant judgment as TAZVERIK was first launched in the first half of 2020 and there is little history with which to base such estimates. In addition, the Company’s ongoing efforts to eliminate costs not related to the Company’s strategic focus contains uncertainties as to whether the Company can attain such benefits. Based on the analysis, the Company concluded that its available cash, cash equivalents and marketable securities as of December 31, 2021 combined with the $79.5 million raised in January 2022 (see Note 18 for further information) will be sufficient to fund current planned operations and capital expenditure requirements and pay its debt service obligations as they become due into the third quarter of 2023 which is at least 12 months from the filing date of this Annual Report on Form 10-K with the SEC. As a result, the Company concluded that it did not identify conditions or events that raise substantial doubt about the Company’s ability to continue as a going concern within one year from the date these financial statements were issued. The Company’s current operating plan is based on assumptions that may prove to be wrong, and the Company could use its capital resources sooner than it expects, in which case the Company would evaluate further reductions in its expenses or obtaining additional financing sooner than it otherwise would, which additional financing may not be available or may only be available on terms that are not acceptable to the Company. |
Accounts Receivable | Accounts Receivable The Company extends credit to customers based on its evaluation of the customer’s financial condition. The Company records receivables for all billings when amounts are due under standard terms. Accounts receivable are stated at amounts due net of applicable prompt pay discounts and other contractual adjustments as well as an allowance for doubtful accounts. The Company assesses the need for an allowance for doubtful accounts by considering a number of factors, including the length of time trade accounts receivable are past due, the customer’s ability to pay its obligation and the condition of the general economy and the industry as a whole. The Company will write off accounts receivable when the Company determines that they are uncollectible. In general, the Company has experienced no significant collection issues with its customers. |
Concentration of Credit Risk | Concentration of Credit Risk Financial instruments that potentially subject the Company to concentrations of credit risk include cash, cash equivalents, marketable securities and accounts receivable. The Company attempts to minimize the risks related to cash, cash equivalents and marketable securities by working with highly rated financial institutions that invest in a broad and diverse range of financial instruments as defined by the Company. The Company has established guidelines relative to credit ratings and maturities intended to safeguard principal balances and maintain liquidity. The Company maintains its funds in accordance with its investment policy, which defines allowable investments, specifies credit quality standards and is designed to limit the Company’s credit exposure to any single issuer. Accounts receivable represent amounts due from customers and collaboration partners. The Company monitors economic conditions to identify facts or circumstances that may indicate that any of its accounts receivable are at risk of collection. For a further discussion of concentration of credit risk see Note 3, Product Revenue, Net . |
Property and Equipment | Property and Equipment The Company records property and equipment at cost. Property and equipment acquired under a capital lease is recorded at the lesser of the present value of the minimum lease payments under the capital lease or the fair value of the leased property at lease inception. The Company calculates depreciation and amortization using the straight-line method over the following estimated useful lives: Asset Category Useful Lives Laboratory equipment 3 - 6 years Computer and office equipment, and furniture 3 - 10 years Leasehold improvements 3 - 6 years or term of respective lease, if shorter Amortization of capital lease assets is included in depreciation expense. The Company capitalizes expenditures for new property and equipment and improvements to existing facilities and charges the cost of maintenance to expense. The Company eliminates the cost of property retired or otherwise disposed of, along with the corresponding accumulated depreciation, from the related accounts, and the resulting gain or loss is reflected in the results of operations. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets The Company reviews long-lived assets to be held and used, including property and equipment and intangible assets, for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets or asset group may not be recoverable. Evaluation of recoverability is based on an estimate of undiscounted future cash flows resulting from the use of the asset or asset group and its eventual disposition. In the event that such cash flows are not expected to be sufficient to recover the carrying amount of the asset or asset group, the assets are written down to their estimated fair values. No such impairments were recorded during 2021, 2020 or 2019 . |
Income Taxes | Income Taxes The Company records deferred income taxes to recognize the effect of temporary differences between tax and financial statement reporting. The Company calculates the deferred taxes using enacted tax rates expected to be in place when the temporary differences are realized and records a valuation allowance to reduce deferred tax assets if it is determined that it is more likely than not that all or a portion of the deferred tax asset will not be realized. The Company considers many factors when assessing the likelihood of future realization of deferred tax assets, including recent earnings results, expectations of future taxable income, carryforward periods available and other relevant factors. The Company records changes in the required valuation allowance in the period that the determination is made. The Company assesses its income tax positions and records tax benefits for all years subject to examination based upon management’s evaluation of the facts, circumstances and information available as of the reporting date. For those tax positions where it is more likely than not that a tax benefit will be sustained, the Company records the largest amount of tax benefit with a greater than 50.0 % likelihood of being realized upon ultimate settlement with a taxing authority having full knowledge of all relevant information. For those income tax positions where it is not more likely than not that a tax benefit will be sustained, the Company does not recognize a tax benefit in the financial statements. The Company records interest and penalties related to uncertain tax positions, if applicable, as a component of income tax expense. Refer to Note 8, Income Taxes , for additional information regarding the Company’s income taxes. |
Other Revenue | Revenue Recognition – Other Revenue Other revenue consists of revenue from the sales of tazemetostat active pharmaceutical ingredient (API) and drug product to the Company’s licensees or collaborators. The Company recognizes revenue on tazemetostat API and drug product when control has transferred under the terms of each agreement. |
Cost of Revenues | Cost of Revenues Cost of revenues primarily consists of costs related to the sales of TAZVERIK and sales of tazemetostat API and drug product to the Company’s licensees or collaborators. These costs include materials, labor, manufacturing overhead, amortization of milestone payments, and royalties payable on net sales of TAZVERIK. Cost of revenues for the year ended December 31, 2021 included approximately $0.8 million related to sales of tazemetostat drug produc t. There were no cost of revenues for the sales of tazemetostat drug product during the year ended December 31, 2020 and 2019. |
Research and Development Expenses | Research and Development Expenses Research and development expenses are expensed as incurred. Research and development expenses are comprised of costs incurred in providing research and development activities, including salaries and benefits, facilities costs, overhead costs, contract research and development services, and other outside costs. Nonrefundable advance payments for goods and services that will be used in future research and development activities are expensed when the activity has been performed or when the goods have been received rather than when the payment is made. External research and development expenses associated with the Company’s programs include clinical trial site costs, clinical manufacturing costs, costs incurred for consultants and other outside services, such as data management and statistical analysis support, and materials and supplies used in support of the clinical and preclinical programs. Internal costs of the Company’s clinical programs include salaries, stock-based compensation, and the portion of the Company’s facility costs allocated to research and development expense. When vendors billing terms do not coincide with the Company’s period-end, the Company is required to make estimates of its obligations to those vendors, including clinical trial and pharmaceutical development costs, contractual services costs and costs for supply of its product candidates incurred in a given accounting period and record accruals at the end of the period. The Company bases its estimates on its knowledge of the research and development programs, services performed for the period, past history for related activities and the expected duration of the vendor service contract, where applicable. The Company generally accrues expenses related to research and development activities based on the services received and efforts expended pursuant to contracts with multiple contract research organizations that conduct and manage clinical trials, as well as other vendors that provide research and development services. Payments for these activities are based on the terms of the individual arrangements and may result in payment terms that differ from the pattern of costs incurred. There may be instances in which payments made to vendors will exceed the level of services provided and result in a prepayment of the clinical expense. Payments under some of these contracts depend on factors such as the successful enrollment of subjects and the completion of clinical trial milestones. In accruing service fees, the Company estimates the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from estimates, the Company would adjust the accrual or prepaid accordingly in future periods. |
Stock-Based Compensation | Stock-Based Compensation The Company measures employee and non-employee stock-based compensation based on the grant date fair value of the stock-based compensation award. The Company grants stock options at exercise prices equal to the fair value of the Company’s common stock on the date of grant, based on observable market prices. The Company recognizes employee stock-based compensation expense on a straight-line basis over the requisite service period of the awards. The Company recognizes forfeitures at the time they occur. The actual expense recognized over the vesting period will only represent those options that vest. For awards with performance conditions in which the award does not vest unless the performance condition is met, the Company recognizes expense if, and to the extent that, the Company estimates that achievement of the performance condition is probable. If the Company concludes that vesting is probable, it recognizes expense from the date it reaches this conclusion through the estimated vesting date. For awards with performance conditions that accelerate vesting of the award, the Company estimates the likelihood of satisfaction of the performance conditions, which affects the period over which the expense is recognized, and recognizes the expense using the accelerated attribution model. Refer to Note 15, Employee Benefit Plans , for additional information regarding the measurement and recognition of expense related to the Company’s stock-based compensation awards. |
Earnings (Loss) per Share | Earnings (Loss) per Share The Company computes basic earnings (loss) per share by dividing income (loss) attributable to common stockholders by the weighted average number of shares of common stock outstanding. During periods of income, the Company allocates participating securities a proportional share of income determined by dividing total weighted average participating securities by the sum of the total weighted average common shares and participating securities (the “two-class method”). The Company’s restricted stock and Series A Convertible Preferred Stock par value of $0.0001 per share (the “Series A Preferred Stock”) participate in dividends declared by the Company and are therefore considered to be participating securities. Participating securities have the effect of diluting both basic and diluted earnings per share during periods of income. During periods of loss, the Company allocates no loss to participating securities because they have no contractual obligation to share in the losses of the Company. The Company computes diluted earnings (loss) per share after giving consideration to the dilutive effect of stock options and warrants that are outstanding during the period, except where such non-participating securities would be anti-dilutive. Refer to Note 16, Loss per Share , for the Company’s calculation of loss per share for the periods presented. |
Segment Information | Segment Information The Company currently operates as one reportable business segment: the discovery, development, and commercialization of novel epigenetic therapies for patients with cancer. |
Recently Adopted Accounting Pronouncements | Recently Adopted Accounting Pronouncements From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies that we adopt as of the specified effective date. Unless otherwise discussed below, we do not believe that the adoption of recently issued standards have or may have a material impact on our consolidated financial statements or disclosures. Revenue Recognition – Collaboration Revenue In November 2018, the FASB, issued ASU 2018-18, Collaborative Arrangements, or ASC 808, which clarifies that certain transactions between collaborative arrangement participants should be accounted for as revenue when the collaborative arrangement participant is a customer in the context of a unit of account and precludes recognizing as revenue consideration received from a collaborative arrangement participant if the participant is not a customer. The new standard was effective in the first quarter of fiscal 2021. The Company adopted ASC 808 effective in the first quarter of fiscal 2021 and the Company’s adoption of this standard did not have a material effect on the Company’s financial statements. Income Taxes In December 2019, the Financial Accounting Standards Board, or the FASB, issued ASU 2019-12, Income Taxes, or ASC 740, which simplifies the accounting for income taxes. The new standard was effective in the first quarter of fiscal 2021. The Company adopted ASC 740 effective in the first quarter of fiscal 2021 and the Company’s adoption of this standard did not have a material effect on the Company’s financial statements. |
Inventory | Inventory The Company outsources the manufacturing of TAZVERIK and uses contract manufacturers to produce the raw and intermediate materials used in the production of TAZVERIK as well as the finished product. The Company currently has one supplier qualified for each step in the manufacturing process and is in the process of qualifying additional suppliers. Inventory is composed of raw materials, intermediate materials, which are classified as work-in-process, and finished goods, which are goods that are available for sale. The Company states inventory at the lower of cost or net realizable value with the cost based on the first-in, first-out method. Inventory is classified as long-term when it is expected to be utilized beyond the Company’s normal operating cycle and is included in restricted cash and other assets on the Company's condensed consolidated balance sheets. If the Company identifies excess, obsolete or unsalable items, it writes down its inventory to its net realizable value in the period in which the impairment is identified. These adjustments are recorded based upon various factors related to the product, including the level of product manufactured by the Company, the level of product in the distribution channel, current and projected demand, the expected shelf-life of the product and firm inventory purchase commitments. Shipping and handling costs incurred for inventory purchases are included in inventory costs and costs incurred for product shipments are recorded as incurred in cost of revenue. Prior to receiving its first approval from the U.S. Food and Drug Administration, or FDA, on January 23, 2020 to sell TAZVERIK, the Company expensed all costs incurred related to the manufacture of TAZVERIK as research and development expense because of the inherent risks associated with the development of a product candidate, the uncertainty about the regulatory approval process and the lack of history for the Company of regulatory approval of drug candidates. |
Intangible Assets, Net | Intangible Assets, Net Intangible assets consist of capitalized milestone payments made to third parties under an in-license of patent rights upon receiving regulatory approval of TAZVERIK. The finite lived intangible assets are being amortized on a straight-line basis over the expected time period the Company will benefit from the in-licensed rights, which is generally the patent life. Intangible assets are recorded at cost at the time of their acquisition and are stated in the Company’s consolidated balance sheets net of accumulated amortization and impairments, if applicable. The amortization expense is recognized as cost of revenue in the Company’s consolidated statement of operations. During 2020 the Company paid a total of $ 50.0 million in milestone payments under its agreement with Eisai, Co., Ltd., or Eisai, upon regulatory approval of tazemetostat for ES and FL. These regulatory milestones have been capitalized as intangible assets. The following table presents intangible assets as of December 31, 2021 (in thousands): December 31, December 31, Estimated useful In-licensed rights $ 50,000 $ 50,000 12.2 Less: accumulated amortization ( 7,151 ) ( 2,998 ) Total intangible asset, net $ 42,849 $ 47,002 The Company recorded approximately $ 4.2 million and $ 3.0 million in amortization expense related to intangible assets, using the straight-line methodology, during the years ended December 31, 2021 and 2020 , respectively. Estimated future amortization expense for intangible assets is approximately $ 4.2 million per year thereafter. The Company assesses its intangible assets for impairment if indicators are present or changes in circumstance suggest that impairment may exist. Events that could result in an impairment, or trigger an interim impairment assessment, include the receipt of additional clinical or nonclinical data regarding one of the Company’s drug candidates or a potentially competitive drug candidate, changes in the clinical development program for a drug candidate, or new information regarding potential sales for the drug. If impairment indicators are present or changes in circumstance suggest that impairment may exist, the Company performs a recoverability test by comparing the sum of the estimated undiscounted cash flows of each intangible asset to its carrying value on the consolidated balance sheet. If the undiscounted cash flows used in the recoverability test are less than the carrying value, the Company would determine the fair value of the intangible asset and recognize an impairment loss if the carrying value of the intangible asset exceeds its fair value. During the three months ended June 30, 2021, the Company concluded the lower than anticipated current and projected future revenue, due to the impact of the COVID-19 pandemic as well as other factors, was an indicator that impairment may exist related to its finite-lived intangible assets. As a result, the Company performed a recoverability test and determined that the finite-lived intangible assets were recoverable. The Company’s quantitative assessment considered significant assumptions related to estimates of future TAZVERIK sales, offset by direct costs to derive the sales. The estimates of future TAZVERIK sales and associated costs include estimates of significant growth, however, these estimates are uncertain as the product was first launched in the first half of 2020 and due to the uncertainties associated with the ongoing COVID-19 pandemic. Given the limited history of sales and the inherent difficulty in making a long-range forecast, such estimates contain significant uncertainty. If the assumptions regarding forecasted revenue or the costs to derive such revenues prove to be inaccurate, the Company may be required to perform future impairment analyses and record an impairment charge for its intangible assets in future periods. |
Leases | Leases At inception of a contract, we determine whether an arrangement is or contains a lease. For all leases, we determine the classification as either operating or financing. As of December 31, 2021, the Company does not have any leases that are classified as finance leases. ROU assets represent our right to use an underlying asset for the lease term, and lease liabilities represent our obligation to make lease payments under the lease. Lease recognition occurs at the commencement date, and lease liability amounts are based on the present value of lease payments made during the lease term. Renewals are not assumed in the determination of the lease term unless they are deemed to be reasonably assured at the inception of the lease. Because our leases do not provide information to determine an implicit interest rate, we use our incremental borrowing rate in determining the present value of lease payments. ROU assets also include any lease payments made prior to the commencement date less lease incentives received. Operating lease expense is recognized on a straight-line basis over the lease term. The Company has elected not to apply the recognition requirements to short-term leases with a term of 12 months or less. Instead, the Company recognizes the lease payments in the consolidated statements of operations and comprehensive loss on a straight-line basis over the lease term. |
Product [Member] | |
Revenue Recognition | Revenue Recognition – Product Revenue The Company recognizes revenue when a customer obtains control of promised goods or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods or services. To determine revenue recognition, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. For a further discussion of accounting for net product revenue see Note 3, Product Revenue, Net . |
Collaboration Revenue [Member] | |
Revenue Recognition | Revenue Recognition – Collaboration Revenue Under ASC 606, Revenue from Contracts with Customers , an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. The Company has entered into collaboration and license agreements, which are within the scope of ASC 606, to discover, develop, manufacture and commercialize product candidates. The terms of these agreements typically contain multiple promises or obligations, which may include: (i) licenses, or options to obtain licenses, to compounds directed to specific targets (referred to as “exclusive licenses”) and (ii) research and development activities to be performed on behalf of the collaboration partner related to the licensed targets. Payments to the Company under these agreements may include non-refundable license fees, customer option exercise fees, payments for research activities, reimbursement of certain costs, payments based upon the achievement of certain milestones and royalties on any resulting net product sales. The Company first evaluates license and/or collaboration arrangements to determine whether the arrangement (or part of the arrangement) represents a collaborative arrangement pursuant to ASC Topic 808, Collaborative Arrangements, based on the risks and rewards and activities of the parties pursuant to the contractual arrangement. The Company accounts for collaborative arrangements (or elements within the contract that are deemed part of a collaborative arrangement) , which represent a collaborative relationship and not a customer relationship, outside the scope of ASC 606. The Company’s collaborations primarily represent revenue arrangements. The Company uses judgment to determine whether milestones or other variable consideration, except for sales-based royalties, should be included in the transaction price as described further below. The transaction price is allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. In determining the stand-alone selling price of a license to the Company’s proprietary technology or a material right provided by a customer option, the Company considers market conditions as well as entity-specific factors, including those factors contemplated in negotiating the agreements as well as internally developed estimates that include assumptions related to the market opportunity, estimated development costs, probability of success and the time needed to commercialize a product candidate pursuant to the license. In validating its estimated stand-alone selling price, the Company evaluates whether changes in the key assumptions used to determine its estimated stand-alone selling price will have a significant effect on the allocation of arrangement consideration between performance obligations. Amounts received prior to revenue recognition are recorded as deferred revenue. Amounts expected to be recognized as revenue within the 12 months following the balance sheet date are classified as current portion of deferred revenue in the accompanying consolidated balance sheets. Amounts not expected to be recognized as revenue within the 12 months following the balance sheet date are classified as deferred revenue, net of current portion. Amounts recognized as revenue, but not yet received or invoiced are generally recognized as contract assets. Exclusive Licenses – If the license to the Company’s intellectual property is determined to be distinct from the other promises or performance obligations identified in the arrangement, which generally include research and development services, the Company recognizes revenue from non-refundable, upfront fees allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. In assessing whether a license is distinct from the other promises, the Company considers relevant facts and circumstances of each arrangement, including the research and development capabilities of the collaboration partner and the availability of the associated expertise in the general marketplace. In addition, the Company considers whether the collaboration partner can benefit from the license for its intended purpose without the receipt of the remaining promises, whether the value of the license is dependent on the unsatisfied promises, whether there are other vendors that could provide the remaining promises, and whether it is separately identifiable from the remaining promises. For licenses that are combined with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. The measure of progress, and thereby periods over which revenue should be recognized, are subject to estimates by management and may change over the course of the research and development and licensing agreement. Research and Development Services – The promises under the Company’s collaboration and license agreements generally include research and development services to be performed by the Company on behalf of the collaboration partner. For performance obligations that include research and development services, the Company generally recognizes revenue allocated to such performance obligations based on an appropriate measure of progress. The Company utilizes judgment to determine the appropriate method of measuring progress for purposes of recognizing revenue, which is generally an input measure such as costs incurred. The Company evaluates the measure of progress each reporting period as described under Exclusive Licenses above. Reimbursements from the partner that are the result of a collaborative relationship with the partner, instead of a customer relationship, such as co-development activities, are recorded as a reduction to research and development expense. Customer Options – The Company’s arrangements may provide a collaborator with the right to select a target for licensing either at the inception of the arrangement or within an initial pre-defined selection period, which may, in certain cases, include the right of the collaborator to extend the selection period. Under these agreements, fees may be due to the Company (i) at the inception of the arrangement as an upfront fee or payment, (ii) upon the exercise of an option to acquire a license or (iii) upon extending the selection period as an extension fee or payment. If an arrangement is determined to contain customer options that allow the customer to acquire additional goods or services, the goods and services underlying the customer options are not considered to be performance obligations at the outset of the arrangement, as they are contingent upon option exercise. The Company evaluates the customer options for material rights, or options to acquire additional goods or services for free or at a discount. If the customer options are determined to represent a material right, the material right is recognized as a separate performance obligation at the inception of the arrangement. The Company allocates the transaction price to material rights based on the relative stand-alone selling price, which is determined based on the identified discount and the probability that the customer will exercise the option. Amounts allocated to a material right are not recognized as revenue until, at the earliest, the option is exercised or expires. Milestone Payments – At the inception of each arrangement that includes development milestone payments, the Company evaluates whether the milestones are considered probable of being achieved and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The Company evaluates factors such as the scientific, clinical, regulatory, commercial, and other risks that must be overcome to achieve the particular milestone in making this assessment. There is considerable judgment involved in determining whether it is probable that a significant revenue reversal would not occur. At the end of each subsequent reporting period, the Company reevaluates the probability of achievement of all milestones subject to constraint and, if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenues and earnings in the period of adjustment. If a milestone or other variable consideration relates specifically to the Company’s efforts to satisfy a single performance obligation or to a specific outcome from satisfying the performance obligation, the Company generally allocates the milestone amount entirely to that performance obligation once it is probable that a significant revenue reversal would not occur. Royalties – For arrangements that include sales-based royalties, including milestone payments based on a level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has not recognized any royalty revenue resulting from any of its licensing arrangements. For a complete discussion of accounting for collaboration revenues, see Note 11, Collaborations . |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Summary of Available-for-Sale Securities Held | The following table summarizes the available for sale securities held at December 31, 2021 (in thousands): Description Amortized Cost Unrealized Unrealized Fair Value Commercial paper $ 68,427 $ 7 $ ( 3 ) $ 68,431 Corporate notes — — — — U.S. government agency securities and U.S. Treasuries 10,025 — ( 1 ) 10,024 Total $ 78,452 $ 7 $ ( 4 ) $ 78,455 The following table summarizes the available for sale securities held at December 31, 2020 (in thousands): Description Amortized Cost Unrealized Unrealized Fair Value Commercial paper $ 158,907 $ 14 $ ( 8 ) $ 158,913 Corporate notes 33,437 3 ( 7 ) 33,433 U.S. government agency securities and U.S. Treasuries 13,044 1 — 13,045 Total $ 205,388 $ 18 $ ( 15 ) $ 205,391 |
Summary of Reconciliation of Cash, Cash Equivalents, and Restricted Cash | A reconciliation of cash, cash equivalents, and restricted cash reported within the consolidated balance sheets that sum to the total of the same such amounts shown in the consolidated statements of cash flows, is as follows: December 31, 2021 2020 2019 (In thousands) Cash and cash equivalents $ 98,336 $ 168,215 $ 139,482 Restricted cash, as part of other assets 1,509 1,509 1509 Total cash, cash equivalents, and restricted cash shown in the consolidated statements of cash flows $ 99,845 $ 169,724 $ 140,991 |
Summary of Company's Financial Assets Recognized at Fair Value | As of December 31, 2021 and December 31, 2020, the Company’s financial assets recognized at fair value consisted of the following: Fair Value as of December 31, 2021 Total Level 1 Level 2 Level 3 (In thousands) Cash equivalents $ 88,637 $ 67,209 $ 21,428 $ — Marketable securities: Commercial paper 68,431 — 68,431 — Corporate notes — — — — U.S. government agency securities and treasuries 10,024 — 10,024 — Total $ 167,092 $ 67,209 $ 99,883 $ — Fair Value as of December 31, 2020 Total Level 1 Level 2 Level 3 (In thousands) Cash equivalents $ 163,264 $ 113,505 $ 49,759 $ — Marketable securities: Commercial paper 158,913 — 158,913 — Corporate notes 33,433 — 33,433 — U.S. government agency securities and treasuries 13,045 — 13,045 — Total $ 368,655 $ 113,505 $ 255,150 $ — |
Useful Lives for Property, Plant and Equipment | The Company calculates depreciation and amortization using the straight-line method over the following estimated useful lives: Asset Category Useful Lives Laboratory equipment 3 - 6 years Computer and office equipment, and furniture 3 - 10 years Leasehold improvements 3 - 6 years or term of respective lease, if shorter |
Summary of Intangible Assets | The following table presents intangible assets as of December 31, 2021 (in thousands): December 31, December 31, Estimated useful In-licensed rights $ 50,000 $ 50,000 12.2 Less: accumulated amortization ( 7,151 ) ( 2,998 ) Total intangible asset, net $ 42,849 $ 47,002 |
Product Revenue Net (Tables)
Product Revenue Net (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
T A Z V E R I K [Member] | |
Concentration Risk [Line Items] | |
Summary of Product Revenue Allowance and Reserve Categories | The following table summarizes activity in each of the above product revenue allowances and reserve categories for the year ended December 31, 2021: Chargebacks, Government Fees Rebates Returns Total (In thousands) Balance, January 1, 2021 $ 133 $ 428 $ 67 $ 628 Provision 1,886 3,093 274 5,253 Payments or credits ( 1,775 ) ( 2,935 ) ( 232 ) ( 4,942 ) Balance, December 31, 2021 $ 244 $ 586 $ 109 $ 939 The following table summarizes activity in each of the above product revenue allowances and reserve categories for the year ended December 31, 2020: Chargebacks, Government Fees Rebates Returns Total (In thousands) Balance, January 1, 2020 $ — $ — $ — $ — Provision 802 1,046 67 1,915 Payments or credits ( 669 ) ( 618 ) — ( 1,287 ) Balance, December 31, 2020 $ 133 $ 428 $ 67 $ 628 |
Net Product Revenue [Member] | |
Concentration Risk [Line Items] | |
Schedules of Concentration of Risk Percentage | Revenue earned from each customer as a percentage of net product revenue is as follows: Year Ended December 31, 2021 2020 Customer 1 30 % 45 % Customer 2 11 % 11 % Customer 3 27 % 20 % Customer 4 21 % 24 % Customer 5 11 % 0 % |
Accounts Receivable [Member] | |
Concentration Risk [Line Items] | |
Schedules of Concentration of Risk Percentage | As of December 31, 2021 and 2020, five individual customers represented as a percentage of accounts receivable as follows: December 31, December 31, Customer 1 15 % 21 % Customer 2 10 % 14 % Customer 3 22 % 29 % Customer 4 29 % 36 % Customer 5 24 % 0 % |
Property and Equipment, net (Ta
Property and Equipment, net (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment, net | Property and equipment, net consists of the following: December 31, 2021 2020 (In thousands) Laboratory equipment $ 4,580 $ 4,435 Computer and office equipment, and furniture 4,386 4,636 Leasehold improvements 453 453 Construction in progress 157 34 Property and equipment 9,576 9,558 Less: accumulated depreciation ( 8,031 ) ( 7,406 ) Property and equipment, net $ 1,545 $ 2,152 |
Inventory (Tables)
Inventory (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Inventory Disclosure [Abstract] | |
Summary of Inventory | All of the Company’s inventory relates to the manufacturing of TAZVERIK. The following table sets forth the Company’s inventory as of December 31, 2021 and December 31, 2020: December 31, December 31, (In thousands) Raw materials $ 3,227 $ 1,068 Work in process 13,748 8,564 Finished goods 1,710 829 Total $ 18,685 $ 10,461 Balance sheet classification Inventory $ 3,216 $ 10,461 Restricted cash and other assets 15,469 — Total $ 18,685 $ 10,461 |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Text Block [Abstract] | |
Schedule of Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets consisted of the following: December 31, 2021 2020 (In thousands) Prepaid clinical and manufacturing costs $ 12,756 $ 12,646 Interest receivable on available for sale securities 72 369 Other prepaid expenses and other receivables 6,637 4,906 Total prepaid expenses and other current assets $ 19,465 $ 17,921 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses consisted of the following: December 31, 2021 2020 (In thousands) Employee compensation and benefits $ 11,737 $ 11,921 Research and development expenses 13,744 10,664 Current portion of liability related to the sale of future royalties 273 — Professional services and other 5,023 5,987 Accrued expenses $ 30,777 $ 28,572 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Schedule of Provision for (Benefit from) Income Taxes | The provision for (benefit from) income taxes for the years ended December 31, 2021, 2020, and 2019 is as follows: 2021 2020 2019 (In thousands) Current $ 22 $ 22 $ ( 34 ) Deferred — 92 92 Total 22 114 58 Income tax provision $ 22 $ 114 $ 58 |
Reconciliation of Federal Statutory Income Tax Rate and Effective Income Tax Rate | A reconciliation of the federal statutory income tax rate and the Company’s effective income tax rate is as follows: Year Ended December 31, 2021 2020 2019 Federal statutory income tax rate 21.0 % 21.0 % 21.0 % State income taxes 5.5 6.1 6.0 Research and development and other tax credits 2.6 2.0 1.9 Permanent items 0.1 ( 0.6 ) ( 0.7 ) Change in valuation allowance ( 27.2 ) ( 27.9 ) ( 27.5 ) Other ( 2.1 ) ( 0.6 ) ( 0.7 ) Effective income tax rate 0.0 % 0.0 % 0.0 % |
Deferred Tax Assets (Liabilities) Included in Other Assets in Consolidated Balance Sheet | The Company’s deferred tax assets (liabilities) included in other assets in the consolidated balance sheets consist of the following: December 31, 2021 2020 (In thousands) Deferred tax assets: Net operating loss carryforwards $ 294,248 $ 238,792 Research and development and other credit carryforwards 41,189 34,205 Accruals and allowances 3,071 2,949 Eisai license payment 10,752 11,935 Stock compensation 8,211 7,338 Other 1,072 1,220 Sale of royalty 4,210 3,857 Lease liability 5,987 5,462 Business interest 7,060 1,220 Gross deferred tax assets 375,800 306,978 Deferred tax asset valuation allowance ( 370,500 ) ( 302,137 ) Total deferred tax assets 5,300 4,841 Deferred tax liabilities: Depreciation and other — ( 18 ) Right of use asset ( 5,300 ) ( 4,709 ) Total deferred tax liabilities ( 5,300 ) ( 4,727 ) Net deferred tax asset $ — $ 114 |
Summary of Unrecognized Tax Benefits | The following is a rollforward of the Company’s unrecognized tax benefits: December 31, 2021 2020 2019 (In thousands) Unrecognized tax benefits - as of beginning of year $ 7,160 $ 6,328 $ 5,743 Gross increases - current period tax positions 1,206 832 585 Unrecognized tax benefits - as of end of year $ 8,366 $ 7,160 $ 6,328 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Leases [Abstract] | |
Summary of Lease Costs and Company's Operating Leases | The following table c ontains a summary of the lease costs recognized under ASC 842 and other information pertaining to the Company’s operating leases for the years ended December 31, 2021, 2020 and 2019: Twelve months ended Twelve months ended Twelve months ended 2021 2020 2019 Lease cost Operating lease cost $ 6,291 $ 6,155 $ 3,771 Variable lease cost 2,039 1,764 1,318 Total lease cost $ 8,330 $ 7,919 $ 5,089 Other information Operating cash flows used for operating leases $ 6,436 $ 4,374 $ 3,648 Weighted average remaining lease term 4.2 years 5.3 years 5.3 years Weighted average discount rate 9.74 % 9.77 % 9.60 % |
Schedule of Future Minimum Lease Payments Under Non-Cancelable Operating Leases | Future minimum lease payments under the Company’s non-cancelable operating leases as of December 31, 2021, are as follows: 2021 (In thousands) 2022 $ 6,202 2023 7,517 2024 7,322 2025 3,057 Thereafter 3,909 Total lease payments $ 28,007 Less: imputed interest ( 5,356 ) Total operating lease liabilities at December 31, 2021 $ 22,651 |
Sale of Future Royalties (Table
Sale of Future Royalties (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Deferred Revenue Disclosure [Abstract] | |
Schedule of Activity of Royalty Obligation | The following table shows the activity of the Royalty Obligation since the transaction inception through December 31, 2021: Year Ended (In thousands ) Proceeds from sale of future royalties $ 12,601 Non-cash royalty revenue ( 31 ) Non-cash interest expense recognized 3,357 Liability related to the sale of future royalties - ending balance 15,927 Less current portion ( 273 ) Related party liability related to sale of future royalties, net of current portion $ 15,654 |
Long Term Debt (Tables)
Long Term Debt (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
Schedule of Minimum Aggregate Future Loan Payments | The Company has the following minimum aggregate future loan payments at December 31, 2021 (in thousands): Year Ended 2022 — 2023 — 2024 70,000 2025 75,000 2026 75,000 Total minimum payments 220,000 Less amounts representing interest and discount ( 3,539 ) Less current portion — Related party long-term debt, net of debt discount $ 216,461 |
Stockholders' Equity (Deficit)
Stockholders' Equity (Deficit) (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Equity [Abstract] | |
Summary of Change in Fair Value of Warrant Liability | The following table rolls forward the fair value of the HutchMed Warrant liability, the fair value of which is determined by Level 3 inputs at inception on August 7, 2021, and as of December 31, 2021: (In thousands) Fair value at inception $ 13,050 Decrease in fair value ( 11,120 ) Fair value at December 31, 2021 $ 1,930 |
Summary of Key Assumptions Used to Value Warrant | The key assumptions used to value the HutchMed Warrant were as follows: Inception As of December 31, 2021 Risk-free interest rate 0.6 % 1.05 % Expected term (in years) 4.0 years 3.6 years Expected volatility of underlying stock 70.0 % 70.0 % Expected dividend yield - - Stock price $ 6.47 $ 2.50 |
Employee Benefit Plans (Tables)
Employee Benefit Plans (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Schedule of Stock-Based Compensation Expense | Stock-based compensation expense is classified in the consolidated statements of operations and comprehensive loss as follows: Year Ended December 31, 2021 2020 2019 (In thousands) Research and development $ 8,360 $ 9,093 $ 6,295 General and administrative 18,427 18,516 11,721 Total $ 26,787 $ 27,609 $ 18,016 |
Weighted Average Assumptions Used in Applying Pricing Model | Weighted average assumptions used in this pricing model on the date of grant for options granted to employees are as follows: Year Ended December 31, 2021 2020 2019 Risk-free interest rate 0.7 % 0.9 % 2.2 % Expected life of options 5.89 years 5.99 years 6.0 years Expected volatility of underlying stock 70.0 % 70.9 % 72.0 % Expected dividend yield 0.0 % 0.0 % 0.0 % |
Summary of Stock Option Activity | The following is a summary of stock option activity for the year ended December 31, 2021: Number of Weighted Weighted Aggregate (In thousands) (In years) (In thousands) Outstanding at December 31, 2020 10,225 $ 14.77 Granted 6,422 7.81 Exercised ( 104 ) 8.83 Forfeited or expired ( 3,597 ) 13.88 Outstanding at December 31, 2021 12,946 $ 11.61 7.62 $ - Exercisable at December 31, 2021 5,463 $ 14.39 5.82 $ - |
Summary of Service Based Restricted Stock Units | During the year-ended December 31, 2021 , 2,240,217 restricted stock units (“RSUs”) were granted to executives and employees and 105,944 RSUs were granted to non-employee directors. The awards were service-based. Assuming all service conditions are achieved, the executive and employee RSUs will vest as to 50 %, 33 %, and 25 %, respectively, of the shares of Company common stock underlying the RSUs on an annual basis over two , three , or four year period of time from the grant dates, respectively, and the non-employee director RSUs will vest as to 100 % of the shares of Company common stock underlying the RSUs in full on the earlier of the first anniversary of the grant date and the date of the succeeding annual meeting of stockholders. Number of Weighted (In thousands except per share data) Outstanding at December 31, 2020 668 $ 17.56 Granted 2,346 7.74 Vested ( 187 ) 17.20 Forfeited ( 605 ) 12.15 Outstanding at December 31, 2021 2,222 $ 8.70 |
Loss per Share (Tables)
Loss per Share (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Earnings Per Share [Abstract] | |
Basic and Diluted Loss per Share | Basic and diluted loss per share allocable to common stockholders are computed as follows: Year Ended December 31, 2021 2020 2019 (In thousands except per share data) Net loss $ ( 251,122 ) $ ( 231,694 ) $ ( 170,295 ) Accretion of Series A Preferred Stock — — ( 2,940 ) Net loss attributable to common stockholders $ ( 251,122 ) $ ( 231,694 ) $ ( 173,235 ) Weighted average shares outstanding 102,646 100,960 89,891 Basic and diluted loss per share allocable to common stockholders $ ( 2.45 ) $ ( 2.29 ) $ ( 1.93 ) |
Common Stock Equivalents Excluded from Calculation of Diluted Loss per Share Attributable to Common Stockholders | The following common stock equivalents were excluded from the calculation of diluted loss per share allocable to common stockholders because their inclusion would have been anti-dilutive: Year Ended December 31, 2021 2020 2019 (In thousands) Stock options 12,946 10,225 8,087 Restricted stock units 2,222 669 757 Shares issuable under employee stock purchase plan 155 98 38 Series A Preferred Stock (if converted) 3,378 3,378 3,500 Warrants 8,153 2,500 2,500 26,854 16,870 14,882 |
The Company - Additional Inform
The Company - Additional Information (Detail) - USD ($) $ in Thousands | Aug. 09, 2021 | Sep. 30, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Basis Of Presentation [Line Items] | |||||
Issuance of common stock, Value | $ 15,954 | $ 122,708 | |||
Proceeds from issuance of common stock, net of commissions | 15,954 | $ 0 | 122,991 | ||
Proceeds from sale of redeemable convertible preferred stock | $ 76,000 | ||||
Initial public offering completion date | May 2013 | ||||
Cash, cash equivalents, and marketable securities | $ 176,800 | ||||
Accumulated deficit | (1,239,835) | (988,713) | |||
Selling, general and administrative | 133,955 | 125,178 | 68,303 | ||
Research and development | 130,966 | $ 110,933 | 132,639 | ||
Royalty Pharma [Member] | |||||
Basis Of Presentation [Line Items] | |||||
Aggregate fund, amount | 1,568,300 | ||||
Non-equity funding through collaboration agreement | 268,800 | ||||
Issuance of common stock, Value | $ 78,705 | ||||
RPI Finance Trust [Member] | |||||
Basis Of Presentation [Line Items] | |||||
Proceeds from issuance of common stock, net of commissions | 150,000 | ||||
RPI Finance Trust (RPI) and BioPharma Credit Investments V (Master) LP and BioPharma Credit PLC (the Lenders) [Member] | |||||
Basis Of Presentation [Line Items] | |||||
Fund received from collaborators | 368,100 | ||||
BioPharma Credit Investments V Master LP And BioPharma Credit PLC [Member] | |||||
Basis Of Presentation [Line Items] | |||||
Debt financing received through loan agreement | 218,100 | ||||
Operating Cost Reduction Plan Member | |||||
Basis Of Presentation [Line Items] | |||||
Percentage of cross-functional reduction of current workforce | 11.00% | ||||
Severance and termination-related costs | $ 2,000 | ||||
Selling, general and administrative | $ 1,600 | ||||
Research and development | $ 400 | ||||
IPO Member | |||||
Basis Of Presentation [Line Items] | |||||
Issuance of common stock, Value | $ 855,400 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Detail) | 12 Months Ended | |||
Dec. 31, 2021USD ($)SecuritySegment | Dec. 31, 2020USD ($)Security | Dec. 31, 2019USD ($) | Aug. 11, 2021USD ($) | |
Accounting Policies [Line Items] | ||||
Available-for-sale securities, continuous unrealized loss position, less than twelve months, fair value | $ 28,600,000 | $ 67,700,000 | ||
Investments with an other-than-temporary impairment | 0 | 0 | ||
Realized gains (losses) recognized on sale or maturity of marketable securities | 0 | 0 | ||
Restricted Cash | 1,500,000 | |||
Security deposit | 500,000 | |||
Impairment of long-lived assets | $ 0 | 0 | $ 0 | |
Largest amount of tax benefit | 50.00% | |||
Reportable business segment | Segment | 1 | |||
Amortization Of Intangible Assets | $ 4,200,000 | 3,000,000 | ||
Estimated future amortization of intangible assets | 4,200,000 | |||
Operating lease, liabilities | 22,651,000 | |||
Operating lease, right-of-use assets | 20,054,000 | 17,305,000 | $ 7,000,000 | |
Eisai [Member] | ||||
Accounting Policies [Line Items] | ||||
Milestone payments | $ 50,000 | |||
Letter of Credit [Member] | Technology Square [Member] | ||||
Accounting Policies [Line Items] | ||||
Security deposit | 500,000 | |||
Letter of Credit [Member] | Hampshire Street [Member] | ||||
Accounting Policies [Line Items] | ||||
Security deposit | $ 1,000,000 | |||
U.S. Government Agency [Member] | ||||
Accounting Policies [Line Items] | ||||
Number of securities in unrealized loss position | Security | 1 | |||
Commercial Paper [Member] | ||||
Accounting Policies [Line Items] | ||||
Number of securities in unrealized loss position | Security | 4 | 6 | ||
Corporate Notes [Member] | ||||
Accounting Policies [Line Items] | ||||
Number of securities in unrealized loss position | Security | 7 | |||
U.S. Treasury Securities [Member] | ||||
Accounting Policies [Line Items] | ||||
Number of securities in unrealized loss position | Security | 6 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Summary of Available-for-Sale Securities Held (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Schedule of Available-for-sale Securities [Line Items] | |||
Available-For-Sale Securities Held, Amortized Cost | $ 78,452 | $ 205,388 | |
Available-For-Sale Securities Held, Unrealized Gains | 7 | 18 | |
Available-For-Sale Securities Held, Unrealized Losses | 4 | 15 | |
Available-For-Sale Securities Held, Fair Value | 78,455 | 205,391 | |
Commercial Paper [Member] | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Available-For-Sale Securities Held, Amortized Cost | 68,427 | 158,907 | |
Available-For-Sale Securities Held, Unrealized Gains | 7 | $ 14 | |
Available-For-Sale Securities Held, Unrealized Losses | 3 | 8 | |
Available-For-Sale Securities Held, Fair Value | 68,431 | 158,913 | |
Corporate Notes [Member] | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Available-For-Sale Securities Held, Amortized Cost | 0 | 33,437 | |
Available-For-Sale Securities Held, Unrealized Gains | 0 | $ 3 | |
Available-For-Sale Securities Held, Unrealized Losses | 0 | 7 | |
Available-For-Sale Securities Held, Fair Value | 0 | 33,433 | |
U.S. Government Agency [Member] | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Available-For-Sale Securities Held, Amortized Cost | 10,025 | 13,044 | |
Available-For-Sale Securities Held, Unrealized Gains | 0 | 1 | |
Available-For-Sale Securities Held, Unrealized Losses | 1 | 0 | |
Available-For-Sale Securities Held, Fair Value | $ 10,024 | $ 13,045 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Summary of Reconciliation of Cash, Cash Equivalents, and Restricted Cash (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Cash and Cash Equivalents [Abstract] | |||
Cash and cash equivalents | $ 98,336 | $ 168,215 | $ 139,482 |
Restricted cash, as part of other assets | 1,509 | 1,509 | 1,509 |
Total cash, cash equivalents, and restricted cash shown in the consolidated statements of cash flows | $ 99,845 | $ 169,724 | $ 140,991 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Summary of Company's Financial Assets Recognized at Fair Value (Detail) - Fair Value, Measurements, Recurring [Member] - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Fair Value Assets And Liabilities Measured On Recurring Basis [Line Items] | |||
Cash equivalents | $ 88,637 | $ 163,264 | |
Total | 167,092 | $ 368,655 | |
Commercial Paper [Member] | |||
Fair Value Assets And Liabilities Measured On Recurring Basis [Line Items] | |||
Marketable securities | 68,431 | 158,913 | |
Corporate Notes [Member] | |||
Fair Value Assets And Liabilities Measured On Recurring Basis [Line Items] | |||
Marketable securities | 0 | 33,433 | |
U.S. Government Agency [Member] | |||
Fair Value Assets And Liabilities Measured On Recurring Basis [Line Items] | |||
Marketable securities | 10,024 | 13,045 | |
Level 1 [Member] | |||
Fair Value Assets And Liabilities Measured On Recurring Basis [Line Items] | |||
Cash equivalents | 67,209 | 113,505 | |
Total | 67,209 | 113,505 | |
Level 2 [Member] | |||
Fair Value Assets And Liabilities Measured On Recurring Basis [Line Items] | |||
Cash equivalents | 21,428 | 49,759 | |
Total | 99,883 | $ 255,150 | |
Level 2 [Member] | Commercial Paper [Member] | |||
Fair Value Assets And Liabilities Measured On Recurring Basis [Line Items] | |||
Marketable securities | 68,431 | 158,913 | |
Level 2 [Member] | Corporate Notes [Member] | |||
Fair Value Assets And Liabilities Measured On Recurring Basis [Line Items] | |||
Marketable securities | 0 | 33,433 | |
Level 2 [Member] | U.S. Government Agency [Member] | |||
Fair Value Assets And Liabilities Measured On Recurring Basis [Line Items] | |||
Marketable securities | $ 10,024 | $ 13,045 |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies - Estimated Useful Lives of Assets Acquired (Detail) | 12 Months Ended |
Dec. 31, 2021 | |
Laboratory Equipment [Member] | Minimum [Member] | |
Property, Plant and Equipment [Line Items] | |
Property and equipment estimated useful lives | 3 years |
Laboratory Equipment [Member] | Maximum [Member] | |
Property, Plant and Equipment [Line Items] | |
Property and equipment estimated useful lives | 6 years |
Computer and Office Equipment and Furniture [Member] | Minimum [Member] | |
Property, Plant and Equipment [Line Items] | |
Property and equipment estimated useful lives | 3 years |
Computer and Office Equipment and Furniture [Member] | Maximum [Member] | |
Property, Plant and Equipment [Line Items] | |
Property and equipment estimated useful lives | 10 years |
Leasehold Improvements [Member] | Minimum [Member] | |
Property, Plant and Equipment [Line Items] | |
Property and equipment estimated useful lives | 3 years |
Leasehold Improvements [Member] | Maximum [Member] | |
Property, Plant and Equipment [Line Items] | |
Property and equipment estimated useful lives | 6 years |
Summary of Significant Accoun_9
Summary of Significant Accounting Policies - Summary of Intangible Assets (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
In-licensed rights | $ 50,000 | $ 50,000 |
Less: accumulated amortization | (7,151) | (2,998) |
Total intangible asset, net | $ 42,849 | $ 47,002 |
Estimated useful life (years) | 12 years 2 months 12 days |
Product Revenue Net - Summary o
Product Revenue Net - Summary of Product Revenue Allowance and Reserve Categories (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Valuation And Qualifying Accounts Disclosure [Line Items] | ||
Beginning Balance | $ 628 | |
Provision | $ 1,915 | |
Payments or credits | (1,287) | |
Ending Balance | 628 | |
TAZVERIK [Member] | ||
Valuation And Qualifying Accounts Disclosure [Line Items] | ||
Beginning Balance | 628 | |
Provision | 5,253 | |
Payments or credits | (4,942) | |
Ending Balance | 939 | 628 |
TAZVERIK [Member] | Chargebacks, Discounts, and Fees [Member] | ||
Valuation And Qualifying Accounts Disclosure [Line Items] | ||
Beginning Balance | 133 | |
Provision | 1,886 | 802 |
Payments or credits | (1,775) | (669) |
Ending Balance | 244 | 133 |
TAZVERIK [Member] | Government and Other Rebates [Member] | ||
Valuation And Qualifying Accounts Disclosure [Line Items] | ||
Beginning Balance | 428 | |
Provision | 3,093 | 1,046 |
Payments or credits | (2,935) | (618) |
Ending Balance | 586 | 428 |
TAZVERIK [Member] | Returns [Member] | ||
Valuation And Qualifying Accounts Disclosure [Line Items] | ||
Beginning Balance | 67 | |
Provision | 274 | 67 |
Payments or credits | (232) | 0 |
Ending Balance | $ 109 | $ 67 |
Product Revenue Net - Additiona
Product Revenue Net - Additional Information (Detail) - Customer | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Accounts Receivable [Member] | Credit Concentration Risk [Member] | ||
Product Information [Line Items] | ||
Number of customers | 5 | 5 |
Product Revenue Net - Schedule
Product Revenue Net - Schedule Of Each Customer As a Percentage Of Net Product Revenue (Detail) - Net Product Revenue [Member] - Customer Concentration Risk [Member] | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Customer 1 [Member] | ||
Concentration Risk [Line Items] | ||
Concentration risk, percentage | 30.00% | 45.00% |
Customer 2 [Member] | ||
Concentration Risk [Line Items] | ||
Concentration risk, percentage | 11.00% | 11.00% |
Customer 3 [Member] | ||
Concentration Risk [Line Items] | ||
Concentration risk, percentage | 27.00% | 20.00% |
Customer 4 [Member] | ||
Concentration Risk [Line Items] | ||
Concentration risk, percentage | 21.00% | 24.00% |
Customer Five Member | ||
Concentration Risk [Line Items] | ||
Concentration risk, percentage | 11.00% | 0.00% |
Product Revenue Net - Schedul_2
Product Revenue Net - Schedule Of Each Customer As a Percentage Of Accounts Receivable (Detail) - Accounts Receivable [Member] - Credit Concentration Risk [Member] | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Customer 1 [Member] | ||
Concentration Risk [Line Items] | ||
Concentration risk, percentage | 15.00% | 21.00% |
Customer 2 [Member] | ||
Concentration Risk [Line Items] | ||
Concentration risk, percentage | 10.00% | 14.00% |
Customer 3 [Member] | ||
Concentration Risk [Line Items] | ||
Concentration risk, percentage | 22.00% | 29.00% |
Customer 4 [Member] | ||
Concentration Risk [Line Items] | ||
Concentration risk, percentage | 29.00% | 36.00% |
Customer Five Member | ||
Concentration Risk [Line Items] | ||
Concentration risk, percentage | 24.00% | 0.00% |
Property and Equipment, Net - S
Property and Equipment, Net - Schedule of Property and Equipment, Net (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment | $ 9,576 | $ 9,558 |
Less: accumulated depreciation and amortization | (8,031) | (7,406) |
Property and equipment, net | 1,545 | 2,152 |
Laboratory Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment | 4,580 | 4,435 |
Computer Office Equipment and Furniture [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment | 4,386 | 4,636 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment | 453 | 453 |
Construction in Progress [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment | $ 157 | $ 34 |
Property and Equipment, Net - A
Property and Equipment, Net - Additional Information (Detail) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Property, Plant and Equipment [Abstract] | |||
Depreciation expense | $ 1.1 | $ 1 | $ 0.8 |
Inventory - Summary of Inventor
Inventory - Summary of Inventory (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Inventory [Line Items] | ||
Raw materials | $ 3,227 | $ 1,068 |
Work in process | 13,748 | 8,564 |
Finished goods | 1,710 | 829 |
Total | 18,685 | 10,461 |
Inventory | ||
Inventory [Line Items] | ||
Total | 3,216 | 10,461 |
Restricted Cash And Other Assets | ||
Inventory [Line Items] | ||
Total | $ 15,469 | $ 0 |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets - Schedule of Prepaid Expenses and Other Current Assets (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | ||
Prepaid clinical and manufacturing costs | $ 12,756 | $ 12,646 |
Interest receivable on available for sale securities | 72 | 369 |
Other prepaid expenses and other receivables | 6,637 | 4,906 |
Total prepaid expenses and other current assets | $ 19,465 | $ 17,921 |
Accrued Expenses - Schedule of
Accrued Expenses - Schedule of Accrued Expenses (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Accrued Liabilities, Current [Abstract] | ||
Employee compensation and benefits | $ 11,737 | $ 11,921 |
Research and development expenses | 13,744 | 10,664 |
Current portion of liability related to the sale of future royalties | 273 | 0 |
Professional services and other | 5,023 | 5,987 |
Accrued expenses | $ 30,777 | $ 28,572 |
Income Taxes - Schedule of Prov
Income Taxes - Schedule of Provision for (Benefit from) Income Taxes (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |||
Current | $ 22 | $ 22 | $ (34) |
Deferred | 0 | 92 | 92 |
Total | 22 | 114 | 58 |
Income tax provision | $ 22 | $ 114 | $ 58 |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Federal Statutory Income Tax Rate and Effective Income Tax Rate (Detail) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |||
Federal statutory income tax rate | 21.00% | 21.00% | 21.00% |
State income taxes | 5.50% | 6.10% | 6.00% |
Research and development and other tax credits | 2.60% | 2.00% | 1.90% |
Permanent items | 0.10% | (0.60%) | (0.70%) |
Change in valuation allowance | (27.20%) | (27.90%) | (27.50%) |
Other | (2.10%) | (0.60%) | (0.70%) |
Effective income tax rate | 0.00% | 0.00% | 0.00% |
Income Taxes - Deferred Tax Ass
Income Taxes - Deferred Tax Assets (Liabilities) Included in Other Assets in Consolidated Balance Sheet (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 294,248 | $ 238,792 |
Research and development and other credit carryforwards | 41,189 | 34,205 |
Accruals and allowances | 3,071 | 2,949 |
Eisai license payment | 10,752 | 11,935 |
Stock compensation | 8,211 | 7,338 |
Other | 1,072 | 1,220 |
Sale of royalty | 4,210 | 3,857 |
Lease liability | 5,987 | 5,462 |
Business interest | 7,060 | 1,220 |
Gross deferred tax assets | 375,800 | 306,978 |
Deferred tax asset valuation allowance | (370,500) | (302,137) |
Total deferred tax assets | 5,300 | 4,841 |
Deferred tax liabilities: | ||
Depreciation and other | 0 | (18) |
Right of use asset | (5,300) | (4,709) |
Total deferred tax liabilities | (5,300) | (4,727) |
Net deferred tax asset | $ 0 | $ 114 |
Income Taxes (Operating Loss Ca
Income Taxes (Operating Loss Carryforwards) - Additional Information (Detail) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
United States, Federal [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards | $ 1.1 | |
Operating loss carryforwards, expire at various dates from 2029 through 2037 | 428.5 | |
Operating loss carryforwards, expiration beginning year | 2029 | |
Operating loss carryforwards, expire indefinitely | $ 664.9 | |
Operating loss carryforwards, expiration ending year | 2030 | |
United States, State [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards | $ 1.1 | |
Operating loss carryforwards, expiration beginning year | 2037 |
Income Taxes (Research and Deve
Income Taxes (Research and Development Tax Credit) - Additional Information (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Tax Credit Carryforward [Line Items] | ||
Research and development tax credit carryforward expiration beginning year | 2028 | |
Research and development tax credit carryforward expiration ending year | 2040 | |
Federal orphan drug tax credit carryforwards expiration beginning year | 2033 | |
Expiry period of federal orphan drug tax credit carryforwards | 2041 | |
Federal orphan drug tax credit carryforwards | $ 20,800,000 | |
Accrued tax-related interest or penalties | 0 | $ 0 |
Research Tax Credit Carryforward [Member] | United States, Federal [Member] | ||
Tax Credit Carryforward [Line Items] | ||
Research and development credit carryforwards | 15,600,000 | |
Research Tax Credit Carryforward [Member] | United States, State [Member] | ||
Tax Credit Carryforward [Line Items] | ||
Research and development credit carryforwards | $ 6,100,000 |
Income Taxes - Summary of Unrec
Income Taxes - Summary of Unrecognized Tax Benefits (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |||
Unrecognized tax benefits - as of beginning of year | $ 7,160 | $ 6,328 | $ 5,743 |
Gross increases - current period tax positions | 1,206 | 832 | 585 |
Unrecognized tax benefits - as of end of year | $ 8,366 | $ 7,160 | $ 6,328 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) $ in Millions | 12 Months Ended | ||||||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 30, 2019 | Jul. 31, 2019 | Mar. 31, 2018 | |
Other Commitments [Line Items] | |||||||
Regulatory milestone payments obligation | $ 0.9 | ||||||
Reimbursements receivable of regulatory milestone | 1 | ||||||
Roche [Member] | |||||||
Other Commitments [Line Items] | |||||||
Regulatory milestone payments obligation | 1 | $ 1 | |||||
Payments pursuant to companion diagnostic agreement | $ 9.4 | ||||||
Development costs | 3.4 | $ 4 | $ 2 | ||||
Royalty Pharma [Member] | Roche [Member] | |||||||
Other Commitments [Line Items] | |||||||
Remaining development costs | 1 | $ 10.4 | |||||
Reimbursements receivable of development costs | $ 0.9 | $ 0.9 | |||||
Signed Amendment | Roche [Member] | |||||||
Other Commitments [Line Items] | |||||||
Regulatory milestone payments obligation | 0.5 | ||||||
Fourth Amendment | Roche [Member] | |||||||
Other Commitments [Line Items] | |||||||
Regulatory milestone payments obligation | $ 0.5 | $ 0.5 |
Leases - Additional Information
Leases - Additional Information (Detail) - USD ($) | Aug. 11, 2021 | Aug. 16, 2019 | Dec. 31, 2021 | Dec. 31, 2020 |
Lessee Lease Description [Line Items] | ||||
Monthly base rent | $ 377,000,000 | $ 200,000 | ||
Increase In base rent | 388,000 | 33,000 | ||
Annual increase of base rent | 9,000 | |||
Security deposit | 500,000 | |||
Tenant Allowance | 430,000 | |||
Operating Lease, Right-of-Use Asset | $ 7,000,000 | 20,054,000 | $ 17,305,000 | |
Hampshire Street [Member] | Letter of Credit [Member] | ||||
Lessee Lease Description [Line Items] | ||||
Security deposit | $ 1,000,000 | |||
Operating lease extend description | the Company extended the term of the Technology Square Lease through November 30, 2024. | |||
BMR-Hampshire LLC [Member] | Cambridge [Member] | ||||
Lessee Lease Description [Line Items] | ||||
Operating lease description | the Company entered into a lease, or the Hampshire Street Lease, with BMR-Hampshire LLC, or BMR. The Hampshire Street Lease is for 33,525 rentable square feet of office space in Cambridge, Massachusetts. The Hampshire Street Lease commenced as of December 1, 2019 | |||
Operating lease extend description | the Company with an option to extend the lease term for one additional five-year period | |||
Operating lease rent expense | $ 200,000 | |||
Operating lease rent expense incremental percentage | 2.50% |
Leases - Summary of Lease Costs
Leases - Summary of Lease Costs and Company's Operating Leases (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Leases [Abstract] | |||
Operating lease cost | $ 6,291 | $ 6,155 | $ 3,771 |
Variable lease cost | 2,039 | 1,764 | 1,318 |
Total lease cost | 8,330 | 7,919 | 5,089 |
Operating cash flows used for operating leases | $ 6,436 | $ 4,374 | $ 3,648 |
Weighted average remaining lease term | 4 years 2 months 12 days | 5 years 3 months 18 days | 5 years 3 months 18 days |
Weighted average discount rate | 9.74% | 9.77% | 9.60% |
Leases - Schedule of Future Min
Leases - Schedule of Future Minimum Lease Payments Under Non-Cancelable Operating Leases (Detail) $ in Thousands | Dec. 31, 2021USD ($) |
Leases [Abstract] | |
2022 | $ 6,202 |
2023 | 7,517 |
2024 | 7,322 |
2025 | 3,057 |
Thereafter | 3,909 |
Total lease payments | 28,007 |
Less: imputed interest | (5,356) |
Total operating lease liabilities at December 31, 2021 | $ 22,651 |
Collaborations - Additional Inf
Collaborations - Additional Information (Detail) | Aug. 07, 2021USD ($)$ / sharesshares | Jan. 01, 2011Optiontarget | Nov. 30, 2018USD ($)Installment | Mar. 31, 2015USD ($) | Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | Sep. 30, 2020USD ($) | Mar. 31, 2020USD ($) | Dec. 30, 2019USD ($) | Jul. 31, 2019USD ($) | Mar. 31, 2018USD ($) |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||||||||||
Regulatory milestone payments obligation | $ 900,000 | |||||||||||
Reimbursements receivable of regulatory milestone | 1,000,000 | |||||||||||
Roche [Member] | ||||||||||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||||||||||
Regulatory milestone payments obligation | 1,000,000 | $ 1,000,000 | ||||||||||
Notice period in days | 90 days | |||||||||||
HutchMed License Agreement [Member] | ||||||||||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||||||||||
License agreement date | Aug. 7, 2021 | |||||||||||
Percentage cost incurred for global studies and total number of patients enrolled In the territory | 20.00% | |||||||||||
Percentage cost incurred for global studies not specific to any territory | 20.00% | |||||||||||
Nonrefundable Upfront payment received | $ 25,000,000 | |||||||||||
Clinical Development And Regulatory Milestone Payment Under License Agreement | $ 110,000,000 | |||||||||||
Clinical license agreement expiration terms | HutchMed License Agreement will expire upon the expiration of the last royalty term for the last Licensed Product in the Field in the Territory. HutchMed may terminate the HutchMed License Agreement in its entirety for any or no reason upon 12 months’ prior written notice to the Company. | |||||||||||
Upfront Milestone | $ 13,000,000 | |||||||||||
HutchMed License Agreement [Member] | Common Stock [Member] | ||||||||||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||||||||||
Date prior to which warrants are exercisable | Aug. 7, 2025 | |||||||||||
Class Of Warrant Or Right Exercise Price Of Warrants Or Rights1 | $ / shares | $ 11.50 | |||||||||||
HutchMed License Agreement [Member] | Maximum [Member] | ||||||||||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||||||||||
Sales milestone payment | $ 175,000,000 | |||||||||||
HutchMed License Agreement [Member] | Maximum [Member] | Common Stock [Member] | ||||||||||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||||||||||
Number of securities into which the class of warrant or right may be converted | shares | 5,653,000 | |||||||||||
HutchMed License Agreement [Member] | License Revenue Member | ||||||||||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||||||||||
Collaboration and other revenue | 12,000,000 | |||||||||||
Gsk | ||||||||||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||||||||||
Number of option targets | Optiontarget | 3 | |||||||||||
Eisai [Member] | ||||||||||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||||||||||
Upfront payment made | $ 40,000,000 | |||||||||||
Research and development reduction | 5,300,000 | $ 3,800,000 | ||||||||||
Obligation related to World Wide Royalty | 4,600,000 | 1,700,000 | ||||||||||
Royalties payable | 1,700,000 | 700,000 | ||||||||||
Other Receivables | 100,000 | 100,000 | ||||||||||
Eisai [Member] | Tazemetostat Drug Pruducts [Member] | ||||||||||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||||||||||
Collaboration and other revenue | 6,300,000 | |||||||||||
Eisai [Member] | Maximum [Member] | ||||||||||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||||||||||
Clinical development milestone payments obligation | 70,000,000 | |||||||||||
Regulatory milestone payments obligation | 70,000,000 | |||||||||||
Royalty Pharma [Member] | Roche [Member] | ||||||||||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||||||||||
Remaining unpaid milestone payments | 1,000,000 | $ 10,400,000 | ||||||||||
Reimbursements receivable of development costs | 900,000 | 900,000 | ||||||||||
Boehringer Ingelheim [Member] | ||||||||||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||||||||||
Collaboration and other revenue | $ 26,000,000 | 0 | $ 500,000 | $ 23,800,000 | ||||||||
Deferred revenue | $ 0 | |||||||||||
Company received upfront payment | 15,000,000 | |||||||||||
Research funding for costs to be incurred | $ 5,000,000 | $ 100,000 | $ 400,000 | |||||||||
Research funding costs, payment frequency | quarterly | |||||||||||
Research funding costs, payable installments | Installment | 4 | |||||||||||
Maximum extension term of research period | 1 year | |||||||||||
Signed Amendment | Roche [Member] | ||||||||||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||||||||||
Regulatory milestone payments obligation | 500,000 | |||||||||||
Fourth Amendment | Roche [Member] | ||||||||||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||||||||||
Regulatory milestone payments obligation | $ 500,000 | $ 500,000 |
Sale of Future Royalties - Addi
Sale of Future Royalties - Additional Information (Details) | Dec. 30, 2019USD ($)shares | Nov. 04, 2019USD ($)Tranche$ / sharesshares | Feb. 29, 2020USD ($)shares | Nov. 30, 2019$ / sharesshares | Dec. 31, 2021USD ($)shares | Dec. 31, 2020USD ($)shares | Dec. 31, 2019USD ($) | Nov. 03, 2020USD ($) |
Line Of Credit Facility [Line Items] | ||||||||
Common stock, shares issued | shares | 106,098,000 | 101,627,000 | ||||||
Proceeds from issuance of common stock, net of commissions | $ 15,954,000 | $ 0 | $ 122,991,000 | |||||
Royalty Purchase Agreement [Member] | ||||||||
Line Of Credit Facility [Line Items] | ||||||||
Proceeds from sale of future royalties | 12,601,000 | |||||||
Non cash royalty revenue | 31,000 | 0 | ||||||
Non cash interest expense | $ 1,800,000 | $ 1,400,000 | $ 200,000 | |||||
RPI and Affiliates [Member] | ||||||||
Line Of Credit Facility [Line Items] | ||||||||
Percentage of ownership interest related parties | 8.60% | 9.00% | ||||||
Tazemetostat [Member] | Royalty Purchase Agreement [Member] | ||||||||
Line Of Credit Facility [Line Items] | ||||||||
Non cash royalty revenue | $ 0 | |||||||
RPI Purchase Agreement [Member] | ||||||||
Line Of Credit Facility [Line Items] | ||||||||
Common stock, shares issued | shares | 2,500,000 | 6,666,667 | ||||||
Warrants To Exercise Common Stock | $ / shares | $ 20 | $ 20 | ||||||
Proceed from agreement | $ 100,000,000 | |||||||
Obligation to purchase common stock | 50,000,000 | |||||||
Shares option to sell exercised by underwriters | shares | 2,500,000 | |||||||
Proceeds from issuance of common stock, net of commissions | $ 50,000,000 | $ 50,000,000 | ||||||
Proceeds from sale of future royalties | $ 12,600,000 | |||||||
Effective annual interest Rate | 9.01% | |||||||
RPI Purchase Agreement [Member] | RPI and Affiliates [Member] | ||||||||
Line Of Credit Facility [Line Items] | ||||||||
Payments for Royalties | 0.19% | |||||||
RPI Purchase Agreement [Member] | Achievement of Specified Annual Net Sales [Member] | ||||||||
Line Of Credit Facility [Line Items] | ||||||||
Potential milestone payments | $ 1,500,000,000 | |||||||
Maximum [Member] | Royalty Purchase Agreement [Member] | ||||||||
Line Of Credit Facility [Line Items] | ||||||||
Non cash royalty revenue | $ 100,000 | |||||||
Maximum [Member] | RPI Purchase Agreement [Member] | ||||||||
Line Of Credit Facility [Line Items] | ||||||||
Warrants to purchase shares of common stock | shares | 2,500,000 | 2,500,000 | ||||||
Obligation to purchase share price | $ / shares | $ 20 | |||||||
Loan Agreement [Member] | ||||||||
Line Of Credit Facility [Line Items] | ||||||||
Line of credit facility, maximum borrowing capacity | $ 70,000,000 | |||||||
Number of tranches | Tranche | 3 | |||||||
Loan Agreement [Member] | RPI Purchase Agreement [Member] | ||||||||
Line Of Credit Facility [Line Items] | ||||||||
Common stock, shares issued | shares | 79,000,000 | |||||||
Warrants to purchase shares of common stock | shares | 8,400,000 | |||||||
Proceed from agreement | $ 125,000,000 | |||||||
Proceeds from sale of future royalties | 12,600,000 | |||||||
Transaction costs | 2,000,000 | |||||||
First Tranche [Member] | Loan Agreement [Member] | ||||||||
Line Of Credit Facility [Line Items] | ||||||||
Aggregate principal amount | 25,000,000 | |||||||
First Tranche [Member] | Loan Agreement [Member] | RPI Purchase Agreement [Member] | ||||||||
Line Of Credit Facility [Line Items] | ||||||||
Aggregate principal amount | $ 25,000,000 | |||||||
Second Tranche [Member] | Loan Agreement [Member] | ||||||||
Line Of Credit Facility [Line Items] | ||||||||
Aggregate principal amount | 25,000,000 | |||||||
Third Tranche [Member] | Loan Agreement [Member] | ||||||||
Line Of Credit Facility [Line Items] | ||||||||
Line of credit facility, maximum borrowing capacity | $ 20,000,000 | |||||||
Fourth Tranche [Member] | Amended And Restated Loan Agreement [Member] | ||||||||
Line Of Credit Facility [Line Items] | ||||||||
Line of credit facility, maximum borrowing capacity | $ 150,000,000 |
Sale of Future Royalties - Sche
Sale of Future Royalties - Schedule of Activity of Royalty Obligation (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Deferred Revenue Arrangement [Line Items] | |||
Non-cash interest expense recognized | $ 1,782,000 | $ 1,383,000 | $ 192,000 |
Liability related to the sale of future royalties - ending balance | 15,654,000 | $ 14,176,000 | |
Royalty Purchase Agreement [Member] | |||
Deferred Revenue Arrangement [Line Items] | |||
Proceeds from sale of future royalties | 12,601,000 | ||
Non cash royalty revenue | 31,000 | $ 0 | |
Non-cash interest expense recognized | 3,357,000 | ||
Liability related to the sale of future royalties - ending balance | 15,927,000 | ||
Less current portion | 273,000 | ||
Related party liability related to sale of future royalties, net of current portion | $ 15,654,000 |
Long-Term Debt - Additional Inf
Long-Term Debt - Additional Information (Detail) $ in Millions | Nov. 03, 2020USD ($)Installment | Nov. 30, 2020USD ($) | Nov. 30, 2019USD ($) | Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | Nov. 04, 2019USD ($) |
Tranche Term Loan [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Interest rate of loan | 7.75% | ||||||
Number of quarterly payments of term loan | Installment | 8 | ||||||
Description of prepayment of tranche term loan | Each of the four term loans may be prepaid before maturity in whole or in part, however there is a $50.0 million minimum prepayment for any prepayment of the loans. If the Company prepays any tranche of term loans, in whole or in part, during the first 36 months from the date on which the Lenders funded such tranche of term loans, then the Company must pay a prepayment premium equal to the greater of (x) a make-whole amount equal to the interest that would have accrued on the principal amount to be prepaid and (y) a premium equal to 0.03 multiplied by the principal amount to be prepaid. If the Company prepays a tranche of term loan, in whole or in part, between the 36th month and 48th month from the date on which the Lenders funded such tranche of term loans, then the Company must pay a prepayment premium equal to 0.02 multiplied by the principal amount to be prepaid. If the Company prepays a tranche of term loans, in whole or in part, between the 48th month and 60th month from the date on which the Lenders funded such tranche of term loans, then the Company must pay a prepayment premium equal to 0.01 multiplied by the principal amount to be prepaid. | ||||||
Tranche Term Loan [Member] | Interest Rate Floor [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Interest rate of loan | 2.00% | ||||||
First Tranche [Member] | BioPharma Credit Investments V (Master) LP [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Interest Expense Credit Facilities | $ 22.5 | $ 7.2 | $ 0.3 | ||||
Minimum [Member] | Tranche Term Loan [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Prepayment of loan | $ 50 | ||||||
Loan Agreement [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Aggregate principal amount | $ 70 | ||||||
Percentage of commitment fee paid | 2.00% | 2.00% | |||||
Commitment fee | $ 150 | $ 70 | |||||
Loan Agreement [Member] | Maximum [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Right to request for additional loan amount | $ 300 | ||||||
Amended And Restated Loan Agreement [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Aggregate principal amount | $ 150 | ||||||
Number of quarterly payments of term loan | Installment | 4 | ||||||
Debt intrument outstanding interest only payment | $ 70 | ||||||
Principal And Interest Due | $ 70 | ||||||
Amended And Restated Loan Agreement [Member] | Tranche Term Loan [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Number of quarterly payments of term loan | Installment | 8 |
Long-Term Debt - Schedule of Mi
Long-Term Debt - Schedule of Minimum Aggregate Future Loan Payments (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Long-term Debt, Fiscal Year Maturity [Abstract] | ||
2022 | $ 0 | |
2023 | 0 | |
2024 | 70,000 | |
2025 | 75,000 | |
2026 | 75,000 | |
Total minimum payments | 220,000 | |
Less amounts representing interest and discount | (3,539) | |
Less current portion | 0 | |
Long-term debt, net of current portion | $ 216,461 | $ 215,670 |
Stockholders' Equity (Deficit_2
Stockholders' Equity (Deficit) - Additional Information (Detail) - USD ($) | May 06, 2021 | Dec. 30, 2019 | Nov. 04, 2019 | Aug. 31, 2021 | Feb. 29, 2020 | Nov. 30, 2019 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Aug. 07, 2021 | Apr. 08, 2021 |
Equity [Line Items] | ||||||||||||
Number of votes for each share of common stock | Each share of common stock entitles the holder to one vote on all matters submitted to a vote of the Company’s stockholders. | |||||||||||
Common stock, shares authorized | 150,000,000 | 125,000,000 | ||||||||||
Common stock, par value | $ 0.0001 | $ 0.0001 | ||||||||||
Proceeds from issuance of common stock, net of commissions | $ 15,954,000 | $ 0 | $ 122,991,000 | |||||||||
Issuance costs | 308,000 | $ 79,000 | 284,000 | |||||||||
Issuance of common stock, Value | $ 15,954,000 | 122,708,000 | ||||||||||
Preferred stock, shares outstanding | 338,000 | 338,000 | ||||||||||
Preferred stock, shares issued | 338,000 | 338,000 | ||||||||||
Net proceeds from sale of shares | $ 0 | $ 0 | $ 37,432,000 | |||||||||
Preferred stock, par value | $ 0.0001 | $ 0.0001 | ||||||||||
Non cash gains due to adjustment of warrant liability | $ 11,100,000 | |||||||||||
HutchMed Warrants [Member] | ||||||||||||
Equity [Line Items] | ||||||||||||
Common stock price per share | $ 2.50 | $ 6.47 | ||||||||||
Warrants to purchase shares of common stock | 5,653,000,000 | |||||||||||
Warrants to exercise common stock | $ 11.50 | |||||||||||
Proceeds from sale of equity securities fair value | 5,653,000,000 | |||||||||||
Number of Shares Purchasable Reduced Upon Condition | 2,826,500 | |||||||||||
Warrant liability | $ 13,000,000 | |||||||||||
Series A Convertible Preferred Stock [Member] | ||||||||||||
Equity [Line Items] | ||||||||||||
Preferred stock, shares outstanding | 337,800,000 | 337,800,000 | ||||||||||
Preferred stock, voting rights | Shares of Series A Preferred Stock will generally have no voting rights except as required by law and except that the consent of the holders of a majority of the outstanding shares of Series A Preferred Stock will be required to amend the terms of the Series A Preferred Stock or take certain other actions with respect to the Series A Preferred Stock. | |||||||||||
Liquidation preference per share | $ 0.001 | |||||||||||
Number of common shares convertible for each share of convertible preferred stock | 10 | |||||||||||
Percentage of conversion restriction upon holder of convertible preferred stock shares | 9.99% | |||||||||||
Conversion of stock notice period | 61 days | |||||||||||
Open Market Sale Agreement [Member] | ||||||||||||
Equity [Line Items] | ||||||||||||
Common stock shares issued | 3,840,977,000 | |||||||||||
Issuance costs | $ 500,000 | |||||||||||
Jefferies L L C [Member] | Open Market Sale Agreement [Member] | ||||||||||||
Equity [Line Items] | ||||||||||||
Company common stock aggregate offering price | $ 200,000 | |||||||||||
Commission proceeds from sale | 3.00% | |||||||||||
RPI Purchase Agreement [Member] | ||||||||||||
Equity [Line Items] | ||||||||||||
Proceeds from issuance of common stock, net of commissions | $ 50,000,000 | $ 50,000,000 | ||||||||||
Warrants to exercise common stock | $ 20 | $ 20 | ||||||||||
RPI Purchase Agreement [Member] | Maximum [Member] | ||||||||||||
Equity [Line Items] | ||||||||||||
Warrants to purchase shares of common stock | 2,500,000 | 2,500,000 | ||||||||||
Proceeds from sale of equity securities fair value | 2,500,000 | 2,500,000 | ||||||||||
Preferred Stock [Member] | ||||||||||||
Equity [Line Items] | ||||||||||||
Issuance of Series A Convertible Preferred Stock, net of commissions and beneficial conversion charge, Shares | 12,200 | |||||||||||
Preferred Stock [Member] | Series A Convertible Preferred Stock [Member] | ||||||||||||
Equity [Line Items] | ||||||||||||
Issuance of Series A Convertible Preferred Stock, net of commissions and beneficial conversion charge, Shares | (12,200) | 350,000 | ||||||||||
Common Stock [Member] | ||||||||||||
Equity [Line Items] | ||||||||||||
Common stock, shares authorized | 150,000,000 | 125,000,000 | 225,000,000,000 | |||||||||
Common stock, par value | $ 0.0001 | |||||||||||
Issuance of common stock, Shares | 2,500,000 | 3,840,977 | 11,500,000 | |||||||||
Issuance of common stock, Value | $ 49,900,000 | $ 1,000 | $ 1,000 | |||||||||
Proceeds from financing Costs after deducting | $ 100,000 | |||||||||||
Issuance of Series A Convertible Preferred Stock, net of commissions and beneficial conversion charge, Shares | 122,000 | |||||||||||
Common Stock [Member] | Series A Convertible Preferred Stock [Member] | ||||||||||||
Equity [Line Items] | ||||||||||||
Issuance of Series A Convertible Preferred Stock, net of commissions and beneficial conversion charge, Shares | 122,000 | |||||||||||
Additional Paid-In Capital [Member] | ||||||||||||
Equity [Line Items] | ||||||||||||
Issuance of common stock, Value | $ 15,953,000 | $ 122,707,000 | ||||||||||
Additional Paid-In Capital [Member] | RPI Purchase Agreement [Member] | ||||||||||||
Equity [Line Items] | ||||||||||||
Proceeds from sale of equity securities fair value | $ 8,400,000 |
Stockholders (Deficit) Equity -
Stockholders (Deficit) Equity - Schedule of Fair Value of Warrant Liability (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Equity [Abstract] | ||
Fair value at Inception | $ 1,930 | $ 13,050 |
Decrease in fair value | (11,120) | |
Fair value at December 31, 2021 | $ 1,930 |
Stockholders (Deficit) Equity_2
Stockholders (Deficit) Equity - Summary of Key Assumptions Used to Value Warrant (Details) - HutchMed Warrants [Member] - $ / shares | Aug. 07, 2021 | Dec. 31, 2021 |
Equity [Line Items] | ||
Risk-free interest rate | 0.60% | 1.05% |
Expected term (in years) | 4 years | 3 years 7 months 6 days |
Expected volatility of underlying stock | 70.00% | 70.00% |
Expected dividend yield | 0.00% | 0.00% |
Stock price | $ 6.47 | $ 2.50 |
Employee Benefit Plans - Additi
Employee Benefit Plans - Additional Information (Detail) - USD ($) | 12 Months Ended | |||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2014 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Weighted average exercise price of options granted | $ 7.81 | |||
Vesting terms | Assuming all service conditions are achieved, the executive and employee RSUs will vest as to 50%, 33%, and 25%, respectively, of the shares of Company common stock underlying the RSUs on an annual basis over two, three, or four year period of time from the grant dates, respectively, and the non-employee director RSUs will vest as to 100% of the shares of Company common stock underlying the RSUs in full on the earlier of the first anniversary of the grant date and the date of the succeeding annual meeting of stockholders. | |||
Share-based compensation expense | $ 26,787,000 | $ 27,609,000 | $ 18,016,000 | |
Aggregate stock options granted to employees, including a non-employee | 6,421,792 | 3,522,258 | 4,222,693 | |
Weighted-average fair value of options granted | $ 4.79 | $ 11.69 | $ 6.99 | |
Grant date fair value of options vested | $ 27,200,000 | $ 17,400,000 | $ 13,200,000 | |
Aggregate intrinsic value of stock option exercised | 100,000 | 5,500,000 | 1,200,000 | |
Unrecognized compensation cost | $ 37,300,000 | |||
Expected weighted average period for recognition of compensation cost | 2 years 3 months 18 days | |||
Percentage of employer's matching contribution | 50.00% | |||
Maximum percentage of employee contribution | 3.00% | |||
Contribution to 401 (k) plan | $ 1,400,000 | $ 1,200,000 | $ 600,000 | |
Defined contribution plan name | 401(k) savings plan | |||
Common Stock [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Aggregate number of stock granted to purchase | 248,366 | |||
2013 Stock Incentive Plan Member | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Weighted average exercise price of options granted | $ 5.12 | |||
Employee Stock Option [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expected dividend yield | 0.00% | 0.00% | 0.00% | |
Restricted Stock Units (RSUs) | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Aggregate number of stock granted to purchase | 106,955 | |||
Restricted Stock Units (RSUs) | 2013 Stock Incentive Plan Member | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Weighted average grant date fair value, Granted | $ 5.08 | |||
Service Based RSU [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Weighted average grant date fair value, Granted | $ 7.74 | |||
Expected weighted average period for recognition of compensation cost | 2 years 2 months 12 days | |||
Restricted stock units outstanding | 2,346,000 | |||
Compensation expense was recognized | $ 4,900,000 | $ 2,700,000 | $ 500,000 | |
Unrecognized compensation cost | $ 14,300,000 | |||
Service Based RSU [Member] | Non-Executive Officer [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Vesting percentage | 100.00% | |||
Service Based RSU [Member] | Share-based Payment Arrangement, Executive and Employee [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Restricted stock units outstanding | 2,240,217 | |||
Service Based RSU [Member] | Share-based Payment Arrangement, Nonemployee [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Restricted stock units outstanding | 105,944 | |||
Performance Based RSU [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Restricted stock units outstanding | 604,000 | |||
Compensation expense was recognized | 3,500,000 | $ 3,600,000 | ||
Unrecognized compensation cost | $ 0 | |||
Vesting Period One [Member] | Service Based RSU [Member] | Executive and Employee [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Vesting period | 2 years | |||
Vesting percentage | 50.00% | |||
Vesting Period Two [Member] | Service Based RSU [Member] | Executive and Employee [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Vesting period | 3 years | |||
Vesting percentage | 33.00% | |||
Vesting Period Three [Member] | Service Based RSU [Member] | Executive and Employee [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Vesting period | 4 years | |||
Vesting percentage | 25.00% | |||
Vest on June 30, 2019 [Member] | Performance Based RSU [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Vesting percentage | 20.00% | |||
Vest on December 31, 2019 [Member] | Performance Based RSU [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Vesting percentage | 25.00% | |||
Vest on March 31, 2020 [Member] | Performance Based RSU [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Vesting percentage | 20.00% | |||
Vest on September 30, 2020 [Member] | Performance Based RSU [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Vesting percentage | 30.00% |
Employee Benefit Plans - Schedu
Employee Benefit Plans - Schedule of Stock-Based Compensation Expense (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Share-based compensation expense | $ 26,787 | $ 27,609 | $ 18,016 |
Research and Development [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Share-based compensation expense | 8,360 | 9,093 | 6,295 |
General and Administrative [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Share-based compensation expense | $ 18,427 | $ 18,516 | $ 11,721 |
Employee Benefit Plans - Weight
Employee Benefit Plans - Weighted Average Assumptions Used in Applying Pricing Model (Detail) - Employee Stock Option [Member] | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Risk-free interest rate | 0.70% | 0.90% | 2.20% |
Expected life of options | 5 years 10 months 20 days | 5 years 11 months 26 days | 6 years |
Expected volatility of underlying stock | 70.00% | 70.90% | 72.00% |
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Employee Benefit Plans - Summar
Employee Benefit Plans - Summary of Stock Option Activity (Detail) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding [Roll Forward] | |||
Number of Options, Outstanding, Beginning balance | 10,225,000 | ||
Number of Options, Granted | 6,421,792 | 3,522,258 | 4,222,693 |
Number of Options, Exercised | (104,000) | ||
Number of Options, Forfeited or expired | (3,597,000) | ||
Number of Options, Outstanding, Ending balance | 12,946,000 | 10,225,000 | |
Number of Options, Exercisable | 5,463,000 | ||
Weighted Average Exercise Price per Share, Outstanding, Beginning balance | $ 14.77 | ||
Weighted Average Grant Date Fair Value | 7.81 | ||
Weighted Average Exercise Price per Share, Exercised | 8.83 | ||
Weighted Average Exercise Price per Share, Forfeited or expired | 13.88 | ||
Weighted Average Exercise Price per Share, Outstanding, Ending balance | 11.61 | $ 14.77 | |
Weighted Average Exercise Price per Share, Exercisable | $ 14.39 | ||
Weighted Average Remaining Contractual Term (In Years), Outstanding | 7 years 7 months 13 days | ||
Weighted Average Remaining Contractual Term (In Years), Exercisable | 5 years 9 months 25 days | ||
Aggregate Intrinsic Value, Outstanding | $ 0 | ||
Aggregate Intrinsic Value, Exercisable | $ 0 |
Employee Benefit Plans - Summ_2
Employee Benefit Plans - Summary of Service Based Restricted Stock Units (Detail) - Service Based RSU [Member] shares in Thousands | 12 Months Ended |
Dec. 31, 2021$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of Outstanding Shares, Beginning Balance | shares | 668 |
Number of Shares, Granted | shares | 2,346 |
Number of Shares, Vested | shares | (187) |
Number of Shares, Forfeited | shares | (605) |
Number of Outstanding Shares, Ending Balance | shares | 2,222 |
Weighted Average Grant Date Fair Value, Beginning Balance | $ / shares | $ 17.56 |
Weighted average grant date fair value, Granted | $ / shares | 7.74 |
Weighted Average Grant Date Fair Value, Vested | $ / shares | 17.20 |
Weighted Average Grant Date Fair Value, Forfeited | $ / shares | 12.15 |
Weighted Average Grant Date Fair Value, Ending Balance | $ / shares | $ 8.70 |
Loss per Share - Additional Inf
Loss per Share - Additional Information (Detail) - USD ($) $ in Thousands | Dec. 30, 2019 | Feb. 29, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Nov. 04, 2019 |
Accretion of series A convertible preferred stock | $ 0 | $ 0 | $ 2,940 | |||
Common stock, shares issued | 106,098,000 | 101,627,000 | ||||
Proceeds from issuance of common stock, net of commissions | $ 15,954 | $ 0 | $ 122,991 | |||
RPI Purchase Agreement [Member] | ||||||
Common stock, shares issued | 2,500,000 | 6,666,667 | ||||
Proceeds from issuance of common stock, net of commissions | $ 50,000 | $ 50,000 | ||||
RPI Purchase Agreement [Member] | Maximum [Member] | ||||||
Additional shares excluded from the additional option to sell | 6,250,000 |
Loss per Share - Schedule of Ba
Loss per Share - Schedule of Basic and Diluted Loss per Share (Detail) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Earnings Per Share [Abstract] | |||
Net loss | $ (251,122) | $ (231,694) | $ (170,295) |
Accretion of convertible preferred stock | 0 | 0 | (2,940) |
Net loss attributable to common stockholders | $ (251,122) | $ (231,694) | $ (173,235) |
Weighted average shares outstanding | 102,646 | 100,960 | 89,891 |
Basic and diluted loss per share allocable to common stockholders | $ (2.45) | $ (2.29) | $ (1.93) |
Loss per Share - Common Stock E
Loss per Share - Common Stock Equivalents from Calculation of Diluted Loss per Share Attributable to Common Stockholders (Detail) - shares shares in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Common stock equivalents excluded from the calculation of diluted loss per share | 26,854 | 16,870 | 14,882 |
Employee Stock Option [Member] | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Common stock equivalents excluded from the calculation of diluted loss per share | 12,946 | 10,225 | 8,087 |
Restricted Stock Units [Member] | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Common stock equivalents excluded from the calculation of diluted loss per share | 2,222 | 669 | 757 |
Shares Issuable Under Employee Stock Purchase Plan [Member] | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Common stock equivalents excluded from the calculation of diluted loss per share | 155 | 98 | 38 |
Series A Preferred Stock [Member] | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Common stock equivalents excluded from the calculation of diluted loss per share | 3,378 | 3,378 | 3,500 |
Warrants [Member] | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Common stock equivalents excluded from the calculation of diluted loss per share | 8,153 | 2,500 | 2,500 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Details) - USD ($) $ / shares in Units, $ in Millions | Mar. 01, 2022 | Aug. 09, 2021 | Jan. 31, 2022 |
Operating Cost Reduction Plan Member | |||
Subsequent Event [Line Items] | |||
Percentage of cross-functional reduction of current workforce | 11.00% | ||
Severance and termination-related costs | $ 2 | ||
Subsequent Event | IPO Member | |||
Subsequent Event [Line Items] | |||
Sale of stock, consideration received on transaction | $ 79.5 | ||
Common stock shares issued | 56,666,667 | ||
Sale of common stock, price per share | $ 1.50 | ||
Subsequent Event | Operating Cost Reduction Plan Member | |||
Subsequent Event [Line Items] | |||
Percentage of cross-functional reduction of current workforce | 12.00% | ||
Subsequent Event | Operating Cost Reduction Plan Member | Minimum [Member] | |||
Subsequent Event [Line Items] | |||
Severance and termination-related costs | $ 2.8 | ||
Subsequent Event | Operating Cost Reduction Plan Member | Maximum [Member] | |||
Subsequent Event [Line Items] | |||
Severance and termination-related costs | $ 3.2 |