Cover Page
Cover Page - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Mar. 09, 2022 | Jun. 30, 2021 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2021 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Transition Report | false | ||
Entity File Number | 001-34655 | ||
Entity Registrant Name | AVEO PHARMACEUTICALS, INC. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 04-3581650 | ||
Entity Address, Address Line One | 30 Winter Street | ||
Entity Address, City or Town | Boston | ||
Entity Address, State or Province | MA | ||
Entity Address, Postal Zip Code | 02108 | ||
City Area Code | 857 | ||
Local Phone Number | 400-0101 | ||
Title of 12(b) Security | Common Stock, $0.001 par value | ||
Trading Symbol | AVEO | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | true | ||
Entity Shell Company | false | ||
Entity Public Float | $ 199.9 | ||
Entity Common Stock, Shares Outstanding | 34,474,710 | ||
Documents Incorporated by Reference | Portions of our definitive proxy statement for our 2022 annual meeting of stockholders are incorporated by reference into Part III of this Annual Report on Form 10-K. | ||
Amendment Flag | false | ||
Document Fiscal Year Focus | 2021 | ||
Document Fiscal Period Focus | FY | ||
Entity Central Index Key | 0001325879 |
Audit Information
Audit Information | 12 Months Ended |
Dec. 31, 2021 | |
Audit Information [Abstract] | |
Auditor Location | Boston, Massachusetts |
Auditor Name | Ernst & Young LLP |
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 | $ 70,542 | $ 61,761 |
Marketable securities | 16,784 | 0 |
Trade receivables, net | 9,811 | 0 |
Partnership receivables | 1,790 | 1,197 |
Inventory | 1,656 | 0 |
Clinical trial retainers | 1,181 | 355 |
Other prepaid expenses and other current assets | 2,972 | 2,195 |
Total current assets | 104,736 | 65,508 |
Property and equipment, net | 276 | 343 |
Operating lease right-of-use asset | 178 | 903 |
Other assets | 151 | 158 |
Total assets | 105,341 | 66,912 |
Current liabilities: | ||
Accounts payable | 2,712 | 3,380 |
Accrued clinical trial costs and contract research | 5,046 | 4,550 |
Employee-related Liabilities, Current | 4,963 | 3,082 |
Other accrued liabilities | 5,421 | 1,381 |
Operating lease liability | 11 | 369 |
Loans payable, net of discount | 0 | 1,056 |
Deferred revenue | 578 | 1,974 |
Deferred research and development reimbursements | 0 | 164 |
PIPE Warrant liability | 0 | 199 |
Other liabilities (Note 6) | 0 | 790 |
Total current liabilities | 18,731 | 16,945 |
Loans payable, net of current portion and discount | 37,960 | 12,716 |
Deferred revenue, non-current | 0 | 578 |
Operating lease liability, non-current | 0 | 336 |
Other liabilities, non-current (Note 6) | 2,780 | 1,043 |
Total liabilities | 59,471 | 31,618 |
Stockholders’ equity: | ||
Preferred stock, $.001 par value: 5,000 shares authorized at December 31, 2021 and December 31, 2020; no shares issued and outstanding at each of December 31, 2021 and December 31, 2020 | 0 | 0 |
Common stock, $.001 par value: 50,000 shares authorized at December 31, 2021 and December 31, 2020; 34,475 shares issued and outstanding at December 31, 2021 and 26,883 issued and outstanding at December 31, 2020 | 34 | 27 |
Additional paid-in capital | 720,386 | 656,472 |
Accumulated other comprehensive loss | (3) | 0 |
Accumulated deficit | (674,547) | (621,205) |
Total stockholders’ equity | 45,870 | 35,294 |
Total liabilities and stockholders’ equity | $ 105,341 | $ 66,912 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2021 | Dec. 31, 2020 |
Stockholders’ equity: | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (in shares) | 5,000,000 | 5,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 50,000,000 | 50,000,000 |
Common stock, shares issued (in shares) | 34,474,710 | 26,883,000 |
Common stock, shares outstanding (in shares) | 34,474,710 | 26,883,000 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2021 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Dec. 31, 2020 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Revenues: | |||||||||||
Revenues | $ 17,646 | $ 15,173 | $ 7,556 | $ 1,920 | $ 42,295 | $ 6,019 | $ 28,795 | ||||
Operating expenses: | |||||||||||
Cost of products sold | $ 2,033 | $ 1,744 | $ 822 | $ 138 | $ 4,737 | $ 0 | $ 0 | ||||
Cost, product and service, extensible enumeration | FOTIVDA U.S. product revenue, net | FOTIVDA U.S. product revenue, net | FOTIVDA U.S. product revenue, net | FOTIVDA U.S. product revenue, net | FOTIVDA U.S. product revenue, net | FOTIVDA U.S. product revenue, net | FOTIVDA U.S. product revenue, net | ||||
Research and development | $ 6,121 | $ 7,502 | $ 6,878 | $ 5,797 | $ 4,574 | $ 5,860 | $ 4,419 | $ 7,826 | $ 26,298 | $ 22,679 | $ 17,958 |
Selling, general and administrative | 15,652 | 15,142 | 14,920 | 15,100 | 9,008 | 5,800 | 3,737 | 3,672 | 60,814 | 22,217 | 11,211 |
Operating expenses | 23,806 | 24,388 | 22,620 | 21,035 | 13,582 | 11,660 | 8,156 | 11,498 | 91,849 | 44,896 | 29,169 |
Loss from operations | (6,160) | (9,215) | (15,064) | (19,115) | (12,696) | (8,060) | (7,407) | (10,714) | (49,554) | (38,877) | (374) |
Other income (expense), net: | |||||||||||
Interest expense, net | (1,153) | (1,153) | (1,128) | (611) | (522) | (419) | (349) | (315) | (4,045) | (1,605) | (1,815) |
Change in fair value of PIPE Warrant liability | 0 | 0 | 2,595 | (2,396) | 1,714 | 86 | 450 | 2,648 | 199 | 4,898 | 11,577 |
Other income | 58 | 0 | 0 | 0 | 58 | 0 | 0 | ||||
Other income (expense), net | (1,095) | (1,153) | 1,467 | (3,007) | 1,192 | (333) | 101 | 2,333 | (3,788) | 3,293 | 9,762 |
Net income (loss) | $ (7,255) | $ (10,368) | $ (13,597) | $ (22,122) | $ (11,504) | $ (8,393) | $ (7,306) | $ (8,381) | $ (53,342) | $ (35,584) | $ 9,388 |
Basic net income (loss) per share | |||||||||||
Net income (loss) per share (in dollars per share) | $ (0.21) | $ (0.30) | $ (0.40) | $ (0.81) | $ (0.44) | $ (0.33) | $ (0.42) | $ (0.52) | $ (1.63) | $ (1.66) | $ 0.61 |
Weighted average number of common shares outstanding (in shares) | 34,384,000 | 34,374,000 | 34,362,000 | 27,429,000 | 26,252,000 | 25,808,000 | 17,364,000 | 16,081,000 | 32,661,000 | 21,402,000 | 15,331,000 |
Diluted net income (loss) per share | |||||||||||
Net income (loss) per share (in dollars per share) | $ (0.21) | $ (0.30) | $ (0.40) | $ (0.81) | $ (0.44) | $ (0.33) | $ (0.42) | $ (0.52) | $ (1.63) | $ (1.66) | $ 0.61 |
Weighted average number of common shares outstanding (in shares) | 34,384,000 | 34,374,000 | 34,362,000 | 27,429,000 | 26,252,000 | 25,808,000 | 17,364,000 | 16,081,000 | 32,661,000 | 21,402,000 | 15,376,000 |
FOTIVDA U.S. product revenue, net | |||||||||||
Revenues: | |||||||||||
Revenues | $ 16,755 | $ 14,318 | $ 6,735 | $ 1,066 | $ 38,874 | $ 0 | $ 0 | ||||
Partnership licensing and royalty revenue | |||||||||||
Revenues: | |||||||||||
Revenues | $ 891 | $ 855 | $ 821 | $ 854 | $ 886 | $ 3,600 | $ 749 | $ 784 | $ 3,421 | $ 6,019 | $ 28,795 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Income (Loss) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Statement of Comprehensive Income [Abstract] | |||
Net income (loss) | $ (53,342) | $ (35,584) | $ 9,388 |
Other comprehensive loss: | |||
Unrealized loss on available-for-sale securities | (3) | 0 | (1) |
Comprehensive income (loss) | $ (53,345) | $ (35,584) | $ 9,387 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Public Offering | Public Offering, Excluding Related Parties | Public Offering, Related Parties | Private Placement | Common Shares | Common SharesPublic Offering | Common SharesPublic Offering, Excluding Related Parties | Common SharesPublic Offering, Related Parties | Common SharesPrivate Placement | Additional Paid-in Capital | Additional Paid-in CapitalPublic Offering | Additional Paid-in CapitalPublic Offering, Excluding Related Parties | Additional Paid-in CapitalPublic Offering, Related Parties | Additional Paid-in CapitalPrivate Placement | Accumulated Other Comprehensive Income | Accumulated Deficit |
Beginning balance (in shares) at Dec. 31, 2018 | 12,648,000 | ||||||||||||||||
Beginning balance at Dec. 31, 2018 | $ (27,227) | $ 13 | $ 567,768 | $ 1 | $ (595,009) | ||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||||||||
Issuance of common stock (in shares) | 1,739,000 | 435,000 | 1,251,000 | ||||||||||||||
Issuance of common stock | $ 17,767 | $ 5,000 | $ 7,512 | $ 2 | $ 1 | $ 17,765 | $ 5,000 | $ 7,511 | |||||||||
Exercise of stock options (in shares) | 8,000 | ||||||||||||||||
Exercise of stock options | 49 | 49 | |||||||||||||||
Stock-based compensation expense related to equity-classified awards | 2,358 | 2,358 | |||||||||||||||
Unrealized loss on available-for-sale securities | (1) | (1) | |||||||||||||||
Net income (loss) | 9,388 | 9,388 | |||||||||||||||
Ending balance (in shares) at Dec. 31, 2019 | 16,081,000 | ||||||||||||||||
Ending balance at Dec. 31, 2019 | 14,846 | $ 16 | 600,451 | 0 | (585,621) | ||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||||||||
Issuance of common stock (in shares) | 5,221,000 | 4,504,000 | 1,070,000 | ||||||||||||||
Issuance of common stock | $ 24,079 | $ 23,644 | 5,917 | $ 5 | $ 5 | $ 1 | $ 24,074 | $ 23,639 | 5,916 | ||||||||
Exercise of stock options (in shares) | 1,000 | ||||||||||||||||
Exercise of stock options | 5 | 5 | |||||||||||||||
Stock-based compensation expense related to equity-classified awards | 2,355 | 2,355 | |||||||||||||||
Issuance of common stock under employee stock purchase plan (in shares) | 6,000 | ||||||||||||||||
Issuance of common stock under employee stock purchase plan | 32 | 32 | |||||||||||||||
Unrealized loss on available-for-sale securities | 0 | ||||||||||||||||
Net income (loss) | (35,584) | (35,584) | |||||||||||||||
Ending balance (in shares) at Dec. 31, 2020 | 26,883,000 | ||||||||||||||||
Ending balance at Dec. 31, 2020 | 35,294 | $ 27 | 656,472 | 0 | (621,205) | ||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||||||||
Issuance of common stock (in shares) | 6,900,000 | 331,000 | |||||||||||||||
Issuance of common stock | $ 51,718 | $ 3,377 | $ 7 | $ 51,711 | $ 3,377 | ||||||||||||
Issuance of common stock in connection with warrant exercises (in shares) | 247,000 | ||||||||||||||||
Issuance of common stock in connection with warrant exercises | $ 3,092 | 3,092 | |||||||||||||||
Exercise of stock options (in shares) | 2,479 | 2,000 | |||||||||||||||
Exercise of stock options | $ 15 | 15 | |||||||||||||||
Stock-based compensation expense related to equity-classified awards | 5,142 | 5,142 | |||||||||||||||
Issuance of common stock under employee stock purchase plan (in shares) | 112,000 | ||||||||||||||||
Issuance of common stock under employee stock purchase plan | 577 | 577 | |||||||||||||||
Unrealized loss on available-for-sale securities | (3) | (3) | |||||||||||||||
Net income (loss) | (53,342) | (53,342) | |||||||||||||||
Ending balance (in shares) at Dec. 31, 2021 | 34,475,000 | ||||||||||||||||
Ending balance at Dec. 31, 2021 | $ 45,870 | $ 34 | $ 720,386 | $ (3) | $ (674,547) |
Consolidated Statements of St_2
Consolidated Statements of Stockholders' Equity (Parenthetical) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Public Offering, Excluding Related Parties | |||
Issuance of common stock, issuance costs | $ 3.5 | $ 3.4 | $ 2.2 |
Private Placement | |||
Issuance of common stock, issuance costs | $ 0.1 | $ 0.2 | $ 0.2 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Operating activities | |||
Net income (loss) | $ (53,342) | $ (35,584) | $ 9,388 |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation and amortization | 67 | 21 | 0 |
Stock-based compensation | 5,142 | 2,355 | 2,358 |
Non-cash interest expense | 1,010 | 469 | 567 |
Non-cash change in fair value of PIPE Warrant liability | (199) | (4,898) | (11,577) |
Amortization of premium and discount on investments | 78 | (106) | (44) |
Changes in operating assets and liabilities: | |||
Trade receivables, net | (9,811) | 0 | 0 |
Partnership receivables | (593) | 433 | 1,395 |
Inventory | (1,656) | 0 | 0 |
Prepaid expenses and other current assets | (1,603) | (1,326) | (742) |
Operating lease right-of-use asset | 832 | (1,060) | 0 |
Other non-current assets | (100) | 0 | 0 |
Accounts payable | (667) | 1,914 | (2,033) |
Accrued clinical trial costs and contract research | 496 | (1,130) | (574) |
Employee Benefits and Share-based Compensation | 1,881 | 1,798 | 238 |
Other accrued liabilities | 4,040 | 329 | (600) |
Operating lease liability | (358) | 369 | 0 |
Deferred revenue | (1,974) | (1,974) | (934) |
Deferred research and development reimbursements | (164) | 71 | (361) |
Operating lease liability, non-current | (336) | 336 | 0 |
Net cash used in operating activities | (57,257) | (37,983) | (2,919) |
Investing activities | |||
Purchases of marketable securities | (28,166) | (36,133) | (17,917) |
Proceeds from maturities and sales of marketable securities | 11,300 | 54,200 | 0 |
Purchases of property and equipment | 0 | (363) | 0 |
Net cash (used in) provided by investing activities | (16,866) | 17,704 | (17,917) |
Financing activities | |||
Proceeds from issuance of common stock, net of issuance costs | 55,095 | 29,996 | 25,279 |
Proceeds from issuance of common stock and warrants to related parties | 0 | 23,644 | 5,000 |
Proceeds from warrant exercises | 3,092 | 0 | 0 |
Proceeds from issuance of stock for stock-based compensation arrangements | 592 | 38 | 49 |
Proceeds from issuance of loan payable | 25,000 | 5,329 | 0 |
Payment on principal of loan payable (Note 6) | 0 | (6,497) | (3,834) |
Payment of loan maturity fees (Note 6) | (790) | 0 | (300) |
Payment of debt issuance costs | (85) | (255) | 0 |
Net cash provided by financing activities | 82,904 | 52,255 | 26,194 |
Net increase in cash and cash equivalents | 8,781 | 31,976 | 5,358 |
Cash and cash equivalents at beginning of period | 61,761 | 29,785 | 24,427 |
Cash and cash equivalents at end of period | 70,542 | 61,761 | 29,785 |
Supplemental cash flow information | |||
Cash paid for interest | 2,888 | 1,337 | 1,971 |
Right-of-use asset obtained in exchange for operating lease liabilities | $ 0 | $ 1,225 | $ 0 |
Organization
Organization | 12 Months Ended |
Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization | Organization AVEO Pharmaceuticals, Inc. (the “Company”) is a commercial stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer. The Company currently markets FOTIVDA ® (tivozanib) in the United States. FOTIVDA is the Company's first commercial product and was approved by the U.S. Food and Drug Administration ("FDA") for marketing and sale in the United States on March 10, 2021 for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (“RCC”) following two or more prior systemic therapies. The Company continues to develop tivozanib in immuno-oncology combinations in RCC and other indications, and the Company has other investigational programs in clinical development. FOTIVDA is an oral, next-generation vascular endothelial growth factor receptor (“VEGFR”) tyrosine kinase inhibitor (“TKI”). The FDA approval of FOTIVDA is based on the Company’s pivotal Phase 3 randomized, controlled, multi-center, open-label clinical trial comparing tivozanib to an approved therapy, Nexavar® (sorafenib), in RCC patients whose disease had relapsed or become refractory to two or three prior systemic therapies, which the Company refers to as the TIVO-3 trial. The approval is also supported by three additional trials in RCC and includes safety data from over 1,000 clinical trial subjects. FOTIVDA became commercially available in the United States on March 22, 2021 and is available to patients through a network of specialty pharmacies and distributors. The Company commercializes FOTIVDA in the United States through the support of approximately 65 field-based employees, which includes approximately 50 oncology sales professionals. The field sales force is supported by the AVEO ACE Patient Support program, which is an extensive patient and healthcare provider support program designed to optimize patient access and help patients navigate their treatment journey. To date, the Company believes it has been very successful in securing payor coverage. Furthermore, the NCCN Clinical Practices Guidelines in Oncology ("NCCN Guidelines") recommended FOTIVDA as a subsequent therapy for patients with relapsed or refractory advanced RCC with clear cell histology who received two or more prior systemic therapies. Based on FOTIVDA’s demonstrated anti-tumor activity, tolerability profile and reduction of regulatory T-cell production, the Company and its collaboration partners are is developing tivozanib in additional cancer indications with significant unmet medical needs including, hepatocellular carcinoma (“HCC”), and tumors that are resistant to immunotherapy, or immunologically cold tumors, in combination with immune checkpoint inhibitors ("ICIs"). In addition, the Company is evaluating tivozanib as a monotherapy in ovarian cancer and cholangiocarcinoma ("CCA"). The Company and the Company's collaboration partners or independent investigators sponsor the development of tivozanib through preclinical studies and clinical trials conducted under collaboration agreements and investigator sponsored trial ("IST") agreements or the Company's Cooperative Research and Development Agreement ("CRADA") with the National Cancer Institute’s Surgical Oncology Program ("NCI-SOP"). The Company is also seeking to advance its pipeline of four wholly owned immunoglobulin G1 (“IgG1”) monoclonal antibody product candidates, ficlatuzumab, AV-380, AV-203 and AV-353. The Company aims to leverage its existing collaborations and partnerships and enter into new strategic collaborations and partnerships to continue to advance each of its product candidates. As used throughout these consolidated financial statements, the terms “AVEO,” and the “Company” refer to the business of AVEO Pharmaceuticals, Inc. and its three wholly owned subsidiaries, AVEO Pharma Limited, AVEO Pharma (Ireland) Limited and AVEO Securities Corporation. Liquidity and Going Concern In accordance with Accounting Standards Update (“ASU”) No. 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern (Subtopic 205-40), the Company has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the consolidated financial statements are issued. The Company’s financial statements have been prepared on the basis of continuity of operations, realization of assets and the satisfaction of liabilities in the ordinary course of business. Through December 31, 2021, the Company has financed its operations primarily through private placements and public offerings of its common stock, license fees, milestone payments and research and development funding from strategic partners, FOTIVDA commercial sales receipts and debt facilities. The Company has devoted substantially all of its resources to its drug development efforts, comprising research and development, manufacturing, conducting clinical trials for its product candidates, commercializing FOTIVDA, protecting its intellectual property and general and administrative functions relating to these operations. The future success of the Company is dependent on its ability to commercialize FOTIVDA in the United States and to develop its portfolio assets and, ultimately, upon the Company’s ability to create shareholder value. On March 10, 2021, the FDA approved FOTIVDA in the United States for the treatment of adult patients with relapsed or refractory advanced RCC following two or more prior systemic therapies. The Company’s future product revenues will depend upon the size of markets in which FOTIVDA, and any future products, have received approval, and its ability to achieve sufficient market acceptance, reimbursement from third-party payors and adequate market share for FOTIVDA and any future products in those markets. The likelihood of the Company’s long-term success must be considered in light of the expenses, difficulties and potential delays that may be encountered in the development and commercialization of new pharmaceutical products, competitive factors in the marketplace and the complex regulatory environment in which the Company operates. Absent the realization of sufficient revenues from product sales to support the Company’s cost structure, the Company may never attain or sustain profitability. The Company has incurred recurring losses and cash outflows from operations since its inception, including an accumulated deficit of $674.5 million as of December 31, 2021. The Company anticipates that it will continue to incur significant operating expenses for the foreseeable future as it commercializes FOTIVDA in the United States and continues its planned development activities for its clinical and preclinical stage assets. The Company may require substantial additional funding to continue to advance its pipeline of clinical and preclinical stage assets, and the timing and nature of these activities will be conducted subject to the availability of sufficient financial resources, principally product sales of FOTIVDA in the United States. As of March 14, 2022, the date of issuance of these consolidated financial statements, the Company expects that its cash, cash equivalents and marketable securities of $87.3 million as of December 31, 2021, along with net product revenues from product sales of FOTIVDA in the United States, will be sufficient to fund its current operations for more than twelve months from the date of filing this Annual Report on Form 10-K . Management’s expectations with respect to its ability to fund current planned operations is based on estimates that are subject to risks and uncertainties, including, without limitation, risks related to its ability to generate product revenue from sales of FOTIVDA in the United States, which became commercially available in the United States on March 22, 2021. If actual results are different from management’s estimates, the Company may need to seek additional strategic or financing opportunities sooner than would otherwise be expected. However, there is no guarantee that any of these strategic or financing opportunities would be executed or executed on favorable terms, and some could be dilutive to existing stockholders. If the Company is unable to obtain additional funding on a timely basis, it may be forced to significantly curtail, delay or discontinue one or more of its planned research or development programs or be unable to expand its operations or otherwise capitalize on its commercialization of its product and product candidates. |
Basis of Presentation
Basis of Presentation | 12 Months Ended |
Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Basis of Presentation | Basis of PresentationThese consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries, AVEO Pharma Limited, AVEO Pharma (Ireland) Limited and AVEO Securities Corporation. The Company has eliminated all significant intercompany accounts and transactions in consolidation. |
Significant Accounting Policies
Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Significant Accounting Policies | Significant Accounting Policies Revenue Recognition Under Accounting Standards Codification (“ASC”) 606, Revenue from Contracts with Customers , the Company recognizes revenue when its customers obtain control of promised goods or services, in an amount that reflects the consideration which the Company determines it expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligation(s) in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligation(s) in the contract; and (v) recognize revenue when (or as) the Company satisfies its performance obligation(s). As part of the accounting for these arrangements, the Company must make significant judgments, including identifying performance obligations in the contract, estimating the amount of variable consideration to include in the transaction price and allocating the transaction price to each performance obligation. Net Product Revenue On March 10, 2021, the FDA approved FOTIVDA in the United States for the treatment of adult patients with relapsed or refractory advanced RCC after two prior systemic therapies. FOTIVDA became commercially available on March 22, 2021. FOTIVDA is the Company’s first commercial product. The Company sells its products principally through a limited distribution network comprised of two specialty pharmacies, Biologics and Onco360, and the following specialty distributors: Amerisource Specialty Distribution, Oncology Supply, McKesson Plasma and Biologics, McKesson Specialty and Cardinal Specialty (collectively with the specialty pharmacies, the "Customers" and each a "Customer"). These Customers subsequently resell the Company’s products to health care providers and patients. In addition to distribution agreements with Customers, the Company enters into arrangements with health care providers and payors that provide for government-mandated and/or privately-negotiated rebates, chargebacks and discounts with respect to the purchase of the Company’s products. Revenues from product sales are recognized when the Customer obtains control of the Company’s product, which occurs at a point in time, typically upon delivery to the Customer. Product Sales Discounts and Allowances The Company records revenues from product sales at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established primarily from discounts, chargebacks, rebates, co-pay assistance, returns 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 sales of its products. These reserves are based on the amounts earned or to be claimed on the related sales and are classified as reductions of trade receivables (if the amount is deductible by the Customer from payments to the Company) or a current liability (if the amount is payable by the Company to a third party or Customer). Where appropriate, these estimates take into consideration a range of possible outcomes that are probability-weighted for relevant factors such as current contractual and statutory requirements, specific known market events and trends, industry data, forecasted Customer buying and payment patterns, and the Company’s historical experience that will develop over time as FOTIVDA is the Company’s first commercial product. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of its contracts. The amount of variable consideration that is included in the transaction price may be constrained, and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. 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 revenues and earnings in the period such variances become known. Chargebacks: Chargebacks are discounts that occur when contracted customers purchase directly from a specialty distributor. Contracted customers, which currently consist primarily of Public Health Service institutions, Federal government entities purchasing via the Federal Supply Schedule, Group Purchasing Organizations and health maintenance organizations, generally purchase the product at a discounted price. The specialty distributor, in turn, charges back to the Company the difference between the price initially paid by the specialty distributor and the discounted price paid to the specialty distributor by its contracted customer. The allowance for chargebacks is based on actual chargebacks received and an estimate of sales by the specialty distributor to its contracted customers. Discounts for Prompt Payment: The Customers receive a discount of 2% for prompt payment. The Company expects its Customers will earn 100% of their prompt payment discounts and, therefore, the Company deducts the full amount of these discounts from total product sales when revenues are recognized. Rebates: Allowances for rebates include mandated discounts under the Medicaid Drug Rebate Program, Medicare Part D Coverage Gap Discounts Program, other government programs and commercial contracts. Rebate amounts owed after the final dispensing of the product to a benefit plan participant are based upon contractual agreements or legal requirements with public sector benefit providers, such as Medicaid. In addition, in the United States during 2020, the Medicare Part D prescription drug benefit mandated participating manufacturers to fund 70% of the Medicare Part D insurance coverage gap for prescription drugs sold to eligible patients. The allowance for rebates is based on statutory or contractual discount rates and expected utilization. The Company’s estimates for the expected utilization of rebates are based on Customer and payer data received from the specialty pharmacies and distributors and historical utilization rates that will develop over time as FOTIVDA is the Company’s first commercial product. Rebates are generally invoiced by the payor and paid in arrears, such that the accrual balance consists of an estimate of the amount expected to be incurred for the current quarter’s shipments to the Customers, plus an accrual balance for known prior quarters’ unpaid rebates. If actual future rebates vary from estimates, the Company may need to adjust its accruals, which would affect net product revenues in the period of adjustment. Co-payment Assistance: Patients who have commercial insurance and meet certain eligibility requirements may receive co-payment assistance. The Company accrues a liability for co-payment assistance based on actual program participation and estimates of program redemption using Customer data provided by the third party that administers the copay program. Other Customer Credits: The Company pays fees to its Customers for account management, data management and other administrative services. To the extent the services received are distinct from the sale of products to its Customers, the Company classifies these payments in selling, general and administrative expenses in its Consolidated Statements of Income. The following table summarizes net product revenues for FOTIVDA in the United States earned in the years ended December 31, 2021, 2020 and 2019, respectively (in thousands): Years Ended 2021 2020 2019 Product revenues: Gross product revenues $ 45,668 $ — $ — Discounts and allowances (6,794) — — Net product revenues $ 38,874 $ — $ — The following table summarizes the percentage of total product revenues for FOTIVDA in the United States by any Customer who individually accounted for 10% or more of total product revenues earned in the years ended December 31, 2021, 2020 and 2019, respectively: Years Ended 2021 2020 2019 OncoMed Specialty, LLC (Onco360) 22 % — — Affiliates of McKesson Corporation 42 % — — Affiliates of AmerisourceBergen Corporation 27 % — — Product Sales Discounts and Allowances The activities and ending allowance balances for each significant category of discounts and allowances for FOTIVDA (which constitute variable consideration) for the year ended December 31, 2021 were as follows (in thousands): Chargebacks, Discounts for Rebates, Customer Fees / Credits Totals Balance at December 31, 2020 $ — $ — $ — Provision related to sales made in: Current period 4,196 2,598 6,794 Prior periods — — — Payments and customer credits issued (3,003) (1,428) (4,431) Balance at December 31, 2021 $ 1,193 $ 1,170 $ 2,363 The allowances for chargebacks, discounts for prompt payment and other allowances are recorded as a reduction of trade receivables, net, and the remaining reserves are recorded as rebates and fees due to customers in other current accrued liabilities in the accompanying Consolidated Balance Sheets. Collaboration Revenues The Company’s historical revenues have been generated primarily through collaborative research, development and commercialization agreements. The terms of these agreements generally contain multiple promised goods and services, which may include (i) licenses, or options to obtain licenses, to the Company’s technology, (ii) research and development activities to be performed on behalf of the collaborative partner and (iii) in certain cases, services in connection with the manufacturing of preclinical and clinical material. Payments to the Company under these arrangements typically include one or more of the following: non-refundable, upfront license fees; option exercise fees; funding of research and/or development efforts; milestone payments; and royalties on future product sales. Collaboration Arrangements Within the Scope of ASC 808, Collaborative Arrangements The Company analyzes its collaboration arrangements to assess whether such arrangements involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards dependent on the commercial success of such activities and are therefore within the scope of ASC Topic 808, Collaborative Arrangements (“ASC 808”). This assessment is performed throughout the life of the arrangement based on changes in the responsibilities of all parties in the arrangement. For collaboration arrangements that are deemed to be within the scope of ASC 808, the Company first determines which elements of the collaboration are deemed to be within the scope of ASC 808 and those that are more reflective of a vendor-customer relationship and therefore within the scope of ASC 606. The Company’s policy is generally to recognize amounts received from collaborators in connection with joint operating activities that are within the scope of ASC 808 as a reduction in research and development expense. Arrangements Within the Scope of ASC 606, Revenue from Contracts with Customers Once a contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within the contract and determines those that are performance obligations. Arrangements that include rights to additional goods or services that are exercisable at a customer’s discretion are generally considered options. The Company assesses if these options provide a material right to the customer and if so, they are considered performance obligations. The exercise of a material right is accounted for as a contract modification for accounting purposes. The Company assesses whether each promised good or service is distinct for the purpose of identifying the performance obligations in the contract. This assessment involves subjective determinations and requires management to make judgments about the individual promised goods or services and whether such are separable from the other aspects of the contractual relationship. Promised goods and services are considered distinct provided that: (i) the customer can benefit from the good or service either on its own or together with other resources that are readily available to the customer (that is, the good or service is capable of being distinct) and (ii) the entity’s promise to transfer the good or service to the customer is separately identifiable from other promises in the contract (that is, the promise to transfer the good or service is distinct within the context of the contract). In assessing whether a promised good or service is distinct, the Company considers factors such as the research, manufacturing and commercialization capabilities of the collaboration partner and the availability of the associated expertise in the general marketplace. The Company also considers the intended benefit of the contract in assessing whether a promised good or service is separately identifiable from other promises in the contract. If a promised good or service is not distinct, an entity is required to combine that good or service with other promised goods or services until it identifies a bundle of goods or services that is distinct. The transaction price is then determined and allocated to the identified performance obligations in proportion to their standalone selling prices (“SSP”) on a relative SSP basis. SSP are determined at contract inception and are not updated to reflect changes between contract inception and when the performance obligations are satisfied. Determining SSP for performance obligations requires significant judgment. In developing SSP for a performance obligation, the Company considers applicable market conditions and relevant entity-specific factors, including factors that were contemplated in negotiating the agreement with the customer and estimated costs. The Company validates SSP for performance obligations by evaluating whether changes in the key assumptions used to determine SSP will have a significant effect on the allocation of arrangement consideration between multiple performance obligations. If the consideration promised in a contract includes a variable amount, the Company estimates the amount of consideration to which it will be entitled in exchange for transferring the promised goods or services to a customer. The Company determines the amount of variable consideration by using the expected value method or the most likely amount method. The Company includes the unconstrained amount of estimated variable consideration in the transaction price. The amount included in the transaction price is constrained to the amount for which it is probable that a significant reversal of cumulative revenue recognized will not occur. At the end of each subsequent reporting period, the Company re-evaluates the estimated variable consideration included in the transaction price and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis in the period of adjustment. In determining the transaction price, the Company adjusts consideration for the effects of the time value of money if the timing of payments provides the Company with a significant benefit of financing. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the licensees and the transfer of the promised goods or services to the licensees will be one year or less. The Company assessed each of its revenue generating arrangements in order to determine whether a significant financing component exists and concluded that a significant financing component does not exist in any of its arrangements. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) each performance obligation is satisfied at a point in time or over time, and if over time based on the use of an output or input method. Licenses of Intellectual Property: The terms of the Company’s license agreements include the license of functional intellectual property, given the functionality of the intellectual property is not expected to change substantially as a result of the Company’s ongoing activities. If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from the portion of the transaction price allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises (that is, for licenses that are not distinct from other promised goods and services in an arrangement), 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. Research and Development Funding: Arrangements that include payment for research and development services are generally considered to have variable consideration. If and when the Company assesses the payment for these services is no longer subject to the constraint on variable consideration, the related revenue is included in the transaction price. Milestone payments: At the inception of each arrangement that includes non-refundable payments for contingent milestones, including preclinical research and development, clinical development and regulatory, 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. At the end of each reporting period, the Company re-evaluates the probability of the achievement of contingent milestones and the likelihood of a significant reversal of such milestone revenue, 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 collaboration and licensing revenue in the period of adjustment. This quarterly assessment may result in the recognition of revenue related to a contingent milestone payment before the milestone event has been achieved. Royalties: For arrangements that include sales-based royalties, including milestone payments based on the 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). The following table summarizes the total collaboration revenues earned in the years ended December 31, 2021, 2020 and 2019, respectively, by partner (in thousands). Refer to Note 4, “Collaborations and License Agreements” regarding specific details. Years Ended 2021 2020 2019 EUSA $ 3,421 $ 3,219 $ 3,795 KKC — 2,800 25,000 Total $ 3,421 $ 6,019 $ 28,795 Trade Receivables Trade receivables, net, includes amounts billed to Customers for product sales of FOTIVDA. The Company records trade receivables net of chargebacks, cash discounts for prompt payment and any allowances for credit losses. The Company considers its historical losses, if any, adjusted to account for current conditions, and reasonable and supportable forecasts of future economic conditions affecting its customers to estimate credit losses. The Customers are specialty pharmacies and specialty distributors, and accordingly, the Company considers the risk of potential credit losses to be low. Cost of Products Sold Cost of products sold is related to the Company's product revenues for FOTIVDA and consists primarily of tiered royalty payments the Company is required to pay to Kyowa Kirin Co. (“KKC”) on all net sales of tivozanib in the Company’s North American territory, which range from the low to mid-teens as a percentage of net sales. Refer to Note 4, “Collaborations and License Agreements” regarding specific details. Cost of products sold also consists of shipping and other third-party logistics and distribution costs for the Company’s products. The Company considered regulatory approval of its product candidate to be uncertain and product manufactured prior to regulatory approval could not have been sold unless regulatory approval was obtained. As such, the manufacturing costs for FOTIVDA incurred prior to regulatory approval were not capitalized as inventory, but were expensed as research and development costs. In 2021, the Company conducted resupply manufacturing of tivozanib in connection with upcoming drug expirations beginning in the fourth quarter of 2022. As of December 31, 2021, the Company capitalized approximately $1.7 million of manufacturing costs as Inventory on the Consolidated Balance Sheet, all of which was classified as work in process. Research and Development Expenses Research and development expenses are charged to expense as incurred. Research and development expenses consist of costs incurred in performing research and development activities, including (i) internal costs for salaries, bonuses, benefits, stock-based compensation, research-related overhead and allocated expenses for facilities and information technology, and (ii) external costs for clinical trials, drug manufacturing and distribution, preclinical studies, upfront license payments, milestones and sublicense fees related to in-licensed products and technology, consultants and other contracted services. Expired Warrants Issued in Connection with Private Placement – Expiration Date of May 16, 2021 In May 2016, the Company issued warrants to purchase an aggregate of 1,764,242 shares of common stock in connection with a private placement financing and recorded the warrants as a liability (the “PIPE Warrants”). The remaining 1,683,933 PIPE Warrants expired on May 16, 2021, as scheduled five years from the date of issuance. The Company accounts for warrant instruments that either conditionally or unconditionally obligate the issuer to transfer assets as liabilities regardless of the timing of the redemption feature or price, even though the underlying shares may be classified as permanent or temporary equity. Refer to Note 7, “ Common Stock—Private Placement – May 2016” for further discussion of the private placement financing. The PIPE Warrants contained a provision giving the warrant holder the option to receive cash, equal to the fair value of the remaining unexercised portion of the warrant, as cash settlement in the event that there had been a fundamental transaction (contractually defined to include various merger, acquisition or stock transfer activities). Due to this provision, ASC 480, Distinguishing Liabilities from Equity required that these warrants be classified as a liability and not as equity. Accordingly, the Company recorded a warrant liability in the amount of approximately $9.3 million upon issuance of the PIPE Warrants. The fair value of these warrants had been determined using the Black-Scholes pricing model. These warrants were subject to revaluation at each balance sheet date and any changes in fair value were recorded as a non-cash gain or (loss) in the Statement of Operations as a component of other income (expense), net until the expiration of the warrants. The Company recorded a non-cash gain of approximately $0.2 million in the year ended December 31, 2021, in its Statement of Operations attributable to the decrease in fair value of the warrant liability that resulted from the expiration of the PIPE Warrants on May 16, 2021. The Company recorded a non-cash gain of approximately $3.1 million in the year ended December 31, 2020, in its Statement of Operations attributable to the decreases in the fair value of the warrant liability that resulted from changes in the Company’s stock price as of December 31, 2020 relative to prior periods, decreases in the Company’s stock volatility rate and a shorter remaining term as the PIPE Warrants approached their expiration in May 2021 . No PIPE Warrants were exercised during the years ended December 31, 2021 and 2020. The following table rolls forward the fair value of the Company’s PIPE Warrant liability, the fair value of which is determined by using Level 3 inputs for the years ended December 31, 2021, 2020 and 2019 (in thousands): Fair value at December 31, 2018 $ 16,674 Decrease in fair value (11,577) Fair value at December 31, 2019 $ 5,097 Decrease in fair value (4,898) Fair value at December 31, 2020 $ 199 Decrease in fair value (199) Fair value at December 31, 2021 $ — The key assumptions used to value the PIPE Warrants were as follows: Issuance December 31, December 31, December 31, Expected price volatility 76.25% 82.64 % 133.07 % 56.79 % Expected term (in years) 5.00 2.5 1.5 0.50 Risk-free interest rates 1.22% 2.47 % 1.59 % 0.09 % Stock price $ 8.90 $ 16.00 $ 6.20 $ 5.77 Dividend yield — — — — Cash and Cash Equivalents The Company considers all highly liquid investments with original maturities of three months or less at the date of purchase and an investment in a United States government money market fund to be cash equivalents. Changes in the balance of cash and cash equivalents may be affected by changes in investment portfolio maturities, as well as actual cash disbursements to fund operations. The Company’s cash is deposited in highly-rated financial institutions in the United States. The Company invests in United States government money market funds, high-grade, short-term commercial paper, corporate bonds and other United States government agency securities, which management believes are subject to minimal credit and market risk. The carrying values of the Company’s cash and cash equivalents approximate fair value due to their short-term maturities. The Company did not have any restricted cash balances at December 31, 2021. Marketable Securities Marketable securities consist primarily of investments which have expected average maturity dates in excess of three months. The Company invests in high-grade corporate obligations, including commercial paper, and United States government and government agency obligations that are classified as available-for-sale. Since these securities are available to fund current operations they are classified as current assets on the consolidated balance sheets. Marketable securities are stated at fair value, including accrued interest, with their unrealized gains and losses included as a component of accumulated other comprehensive income or loss, which is a separate component of stockholders’ equity. The fair value of these securities is based on quoted prices and observable inputs on a recurring basis. The cost of marketable securities is adjusted for amortization of premiums and accretion of discounts, with such amortization and accretion recorded as a component of interest expense, net. Realized gains and losses are determined on the specific identification method. Unrealized gains and losses are included in other comprehensive loss until realized, at which point they would be recorded as a component of interest expense, net. Below is a summary of cash, cash equivalents and marketable securities at December 31, 2021 and December 31, 2020 (in thousands): Amortized Cost Unrealized Unrealized Fair December 31, 2021 Cash and cash equivalents: Cash and money market funds $ 70,542 $ — $ — $ 70,542 Total cash and cash equivalents 70,542 — — 70,542 Marketable securities: Corporate debt securities due within 1 year $ 16,787 $ — $ (3) $ 16,784 Total marketable securities 16,787 — (3) 16,784 Total cash, cash equivalents and marketable securities $ 87,329 $ — $ (3) $ 87,326 December 31, 2020 Cash and cash equivalents: Cash and money market funds $ 61,761 $ — $ — $ 61,761 Total cash, cash equivalents and marketable securities $ 61,761 $ — $ — $ 61,761 Concentrations of Credit Risk Financial instruments that potentially subject the Company to credit risk primarily consist of cash and cash equivalents, marketable securities and accounts receivable. The Company maintains deposits in highly-rated, federally-insured financial institutions in excess of federally insured limits. The Company’s investment strategy is focused on capital preservation. The Company invests in instruments that meet the high credit quality standards outlined in the Company’s investment policy. This policy also limits the amount of credit exposure to any one issue or type of instrument. The Company’s trade receivables, net, includes amounts billed to Customers for product sales of FOTIVDA. The Customers are a limited group of specialty pharmacies and specialty distributors, and accordingly, the Company considers the risk of potential credit losses to be low. The Company’s partnership receivables include amounts due to the Company from licensees and collaborators. The Company has not experienced any material losses related to partnership receivables from individual licensees or collaborators. Fair Value Measurements The fair value of the Company’s financial assets and liabilities reflects the Company’s estimate of amounts that it would have received in connection with the sale of the assets or paid in connection with the transfer of the liabilities in an orderly transaction between market participants at the measurement date. In connection with measuring the fair value of its assets and liabilities, the Company seeks to maximize the use of observable inputs (market data obtained from sources independent from the Company) and to minimize the use of unobservable inputs (the Company’s assumptions about how market participants would price assets and liabilities). The following fair value hierarchy is used to classify assets and liabilities based on the observable inputs and unobservable inputs used in order to value the assets and liabilities: Level 1. Quoted prices in active markets for identical assets or liabilities. An active market for an asset or liability is a market in which transactions for the asset or liability occur with sufficient frequency and volume to provide pricing information on an ongoing basis. Level 2. Observable inputs other than Level 1 inputs. Examples of Level 2 inputs include quoted prices in active markets for similar assets or liabilities and quoted prices for identical assets or liabilities in markets that are not active. Level 3. Unobservable inputs based on the Company’s assessment of the assumptions that market participants would use in pricing the asset or liability. Financial assets and liabilities are classified in their entirety within the fair value hierarchy based on the lowest level of input that is significant to the fair value measurement. The Company measures the fair value of its marketable securities by taking into consideration valuations obtained from third-party pricing sources. The pricing services utilize industry standard valuation models, including both income and market-based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. These inputs include reported trades of and broker-dealer quotes on the same or similar securities, issuer credit spreads, benchmark securities and other observable inputs. As of December 31, 2021, the Company had financial assets valued based on Level 1 inputs consisting of cash and cash equivalents in a United States government money market fund and had financial assets based on Level 2 inputs consisting of high-grade debt securities, including commercial paper. During the year ended December 31, 2021, the Company did not have any transfers of financial assets between Levels 1 and 2. As of December 31, 2021, the C |
Collaborations and License Agre
Collaborations and License Agreements | 12 Months Ended |
Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Collaborations and License Agreements | Collaborations and License Agreements Collaboration Agreement AstraZeneca In December 2018, the Company entered into a clinical supply agreement (the “AstraZeneca Agreement”) with a wholly owned subsidiary of AstraZeneca to evaluate the safety and efficacy of AstraZeneca’s IMFINZI (durvalumab), a human monoclonal antibody directed against PD-L1, in combination with tivozanib as a first-line treatment or following bevacizumab and atezolizumab treatment for patients with advanced, unresectable HCC in an open-label, multi-center, randomized Phase 1b/2 clinical trial (the “DEDUCTIVE trial”). The Company serves as the study sponsor; each party contributes the clinical supply of its study drug; key decisions are made by both parties by consensus; and external study costs are otherwise shared equally. The Company is accounting for the joint development activities under the AstraZeneca Agreement as a joint risk-sharing collaboration in accordance with ASC 808 because both the Company and AstraZeneca are active participants in the oversight of the DEDUCTIVE trial via their participation on a joint steering committee and are exposed to significant risk and rewards in connection with the activity based on their obligation to share in the costs. AstraZeneca does not meet the definition of a “Customer,” thus the joint development activities under the AstraZeneca Agreement are not accounted for under ASC 606. Payments from AstraZeneca with respect to its share of the external costs for the DEDUCTIVE trial incurred by the Company pursuant to a joint development plan are recorded as a reduction in research and development expenses due to the joint risk-sharing nature of the activities that is not representative of a vendor-customer relationship. The Company records reimbursements from AstraZeneca for external study costs as a reduction in research and development expense during the period that reimbursable expenses are incurred. As a result of the cost sharing provisions in the AstraZeneca Agreement, the Company’s research and development expenses were reduced by approximately $0.9 million, $1.1 million, and $0.5 million in the years ended December 31, 2021, 2020 and 2019, respectively. The amount due to the Company from AstraZeneca pursuant to the cost-sharing provision was approximately $0.8 million as of December 31, 2021. Out-License Agreements EUSA In December 2015, the Company entered into a license agreement with EUSA (the “EUSA Agreement”), under which the Company granted to EUSA the exclusive, sublicensable right to develop, manufacture and commercialize tivozanib in the territories of Europe (excluding Russia, Ukraine and the Commonwealth of Independent States), Latin America (excluding Mexico), Africa and Australasia (collectively, the “EUSA Licensed Territories”) for all diseases and conditions in humans, excluding non-oncologic diseases or conditions of the eye. EUSA made research and development reimbursement payments to the Company of $2.5 million upon the execution of the EUSA Agreement during the year ended December 31, 2015 and $4.0 million in September 2017 upon its receipt of marketing approval from the European Commission in August 2017 for FOTIVDA (tivozanib) for the treatment of RCC. In September 2017, EUSA elected to opt-in to co-develop the Phase 2 clinical trial of tivozanib in combination with nivolumab in the first-line and the second-line treatment of RCC (the “TiNivo trial”). As a result of exercising its opt-in right, EUSA made an additional research and development reimbursement payment to the Company of $2.0 million. This $2.0 million payment was received in October 2017, in advance of the completion of the TiNivo trial, and represented EUSA’s approximate 50% share of the total costs of the TiNivo trial. The Company is also eligible to receive an additional research and development reimbursement payment from EUSA, in the amount of $20.0 million, for the Company’s Phase 3 randomized, controlled, multi-center, open-label clinical trial comparing tivozanib to an approved therapy, sorafenib (Nexavar ® ), in RCC patients whose disease had relapsed or become refractory to two or three prior systemic therapies, including subjects with prior checkpoint inhibitor therapy (the “TIVO-3 trial”), if EUSA elects to opt-in to that study. The Company is entitled to receive milestone payments of $2.0 million per country upon reimbursement approval for RCC, if any, in each of France, Germany, Italy, Spain and the United Kingdom (collectively, the “EU5”). The Company is also entitled to receive an additional $2.0 million for the grant of marketing approval for RCC, if any, in three of the licensed countries outside of the EU, as mutually agreed by the parties, of which approvals have been obtained in New Zealand in July 2019 and in South Africa in September 2020. In February 2018, November 2018 and February 2019, EUSA obtained reimbursement approval from the National Institute for Health and Care Excellence (“NICE”) in the United Kingdom, the German Federal Association of the Statutory Health Insurances (“GKV-SV”) in Germany and the Ministry of Health, Consumer Affairs and Social Welfare (“MSCBS”) in Spain, respectively, for the first-line treatment of RCC. Accordingly, the Company earned a $2.0 million milestone payment with respect to reimbursement approval in the United Kingdom that was received in March 2018, a $2.0 million milestone payment with respect to reimbursement approval in Germany that was received in December 2018 and a $2.0 million milestone payment with respect to reimbursement approval in Spain that was received in May 2019. The Company is also eligible to receive a payment of $2.0 million per indication in connection with a filing by EUSA with the European Medicines Agency (“EMA”) for marketing approval, if any, for tivozanib for the treatment of each of up to three additional indications and $5.0 million per indication in connection with the EMA’s grant of marketing approval for each of up to three additional indications, as well as potentially up to $335.0 million upon EUSA’s achievement of certain sales thresholds. The Company is also eligible to receive tiered double-digit royalties on net sales, if any, of licensed products in the EUSA Licensed Territories ranging from a low double digit up to mid-twenty percent depending on the level of annual net sales. No milestone payments nor any research and development reimbursement payments were earned in the years ended December 31, 2021 and 2020. Pursuant to the KKC Agreement (as defined below), the Company is required to pay KKC a 30% sublicense fee related to earned milestone payments and royalties from EUSA. However, research and development reimbursement payments by EUSA are excluded from the 30% sublicense fee due to KKC, subject to certain limitations. If EUSA elects to opt-in to the TIVO-3 trial, only approximately $8.7 million of the final $20.0 million research and development payment by EUSA would be subject to the 30% sublicense fee due to KKC. The $2.0 million milestone payments the Company earned in each of February 2018, November 2018 and February 2019 upon EUSA’s reimbursement approval for FOTIVDA from the NICE in the United Kingdom, the GKV-SV in Germany and the MSCBS in Spain, respectively, for the first-line treatment of RCC were subject to the 30% KKC sublicense fee, or $0.6 million, each. The sublicense fees for EUSA’s reimbursement approvals in the United Kingdom, Germany and Spain were paid in April 2018, January 2019 and June 2019, respectively. EUSA is obligated to use commercially reasonable efforts to seek regulatory approval for and commercialize tivozanib throughout the EUSA Licensed Territories in RCC. EUSA has responsibility for all activities and costs associated with the further development, manufacture, regulatory filings and commercialization of tivozanib in the EUSA Licensed Territories. Accounting Under ASC 606 Under ASC 606, the upfront consideration and regulatory milestones included in the transaction price are being recognized as collaboration and licensing revenue over the Company’s substantive performance period from contract execution in December 2015 through April 2022. Under ASC 606, upon the achievement of a regulatory milestone, the amount that represents the cumulative catch-up for the period from contract execution in December 2015 through the date of the milestone achievement is recognized as collaboration and licensing revenue, with the balance classified as deferred revenue and recognized as collaboration and licensing revenue over the remainder of the performance period, currently estimated through April 2022. None of the remaining regulatory-related milestones are included in the transaction price as these milestone amounts were fully constrained. As part of its evaluation of the constraint, the Company considered multiple factors: (i) the remaining reimbursement and marketing approvals in RCC are outside of the control of EUSA and vary on a country-by-country basis; (ii) milestones related to the submission filings for EMA approval of tivozanib in up to three additional indications are contingent upon the success of future clinical trials in additional indications, if any, and are outside of the control of EUSA; (iii) milestones related to the marketing approval by the EMA for tivozanib in up to three additional indications are contingent upon the success of the corresponding future clinical trials, if any, and are outside of the control of EUSA; and (iv) efforts by EUSA. 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 EUSA and therefore are recognized at the later of when the performance obligation is satisfied (or partially satisfied) or the related sales occur. The Company will re-evaluate the transaction price, including its estimated variable consideration for milestones included in the transaction price and all constrained amounts, in each reporting period and as uncertain events are resolved or other changes in circumstances occur. In November 2017, the Company began earning sales royalties upon EUSA’s commencement of the first commercial launch of FOTIVDA with the initiation of product sales in Germany. EUSA has received reimbursement approval for and commercially launched FOTIVDA in Germany, the United Kingdom and Spain, as well as in some additional non-EU5 countries. EUSA is working to secure reimbursement approval in Italy and France and commercially launch FOTIVDA in additional EUSA licensed territories. The Company recognized royalty revenue of approximately $1.4 million, $1.2 million and $0.9 million in the years ended December 31, 2021, 2020 and 2019, respectively. The Company recognized total revenues under the EUSA Agreement of approximately $3.4 million, $3.2 million and $3.8 million in the years ended December 31, 2021, 2020 and 2019, respectively. As of December 31, 2021, there was approximately $0.6 million in total deferred revenue that is expected to continue to be recognized as collaboration and licensing revenue over the duration of the Company’s performance period, currently estimated through April 2022. The following table summarizes the revenues earned in connection with the EUSA Agreement under ASC 606 for the years ended December 31, 2021, 2020 and 2019 (in thousands): Years Ended Revenue Type Date Achieved 2021 2020 2019 Collaboration and Licensing Revenue: Amounts in contract liabilities at the beginning of the period: Upfront payment December 2015 $ 395 $ 395 $ 395 R&D payment - EMA approval in RCC August 2017 631 631 631 Milestone - UK reimbursement approval February 2018 316 316 316 Milestone - German reimbursement approval November 2018 316 316 316 Milestone - Spanish reimbursement approval February 2019 316 316 1,276 $ 1,974 $ 1,974 $ 2,934 Partnership Royalties 1,447 1,245 861 Total $ 3,421 $ 3,219 $ 3,795 The following table summarizes changes in the Company’s accounts receivable and contract liabilities (deferred revenue) in connection with the EUSA Agreement for the year ended December 31, 2021 (in thousands): Contract Assets Beginning Balance January 1, 2021 Additions Deductions Ending Balance December 31, 2021 Partnership receivables $ 392 $ 1,447 $ (1,079) $ 760 Deferred Revenue Contract Liabilities Transaction Price Date Achieved Date Paid Beginning Balance January 1, 2021 Additions Deductions Ending Balance December 31, 2021 Amounts in contract liabilities at the beginning of the period: Upfront payment $ 2,500 December 2015 December 2015 $ 512 $ — $ 395 $ 117 R&D payment - EMA approval in RCC 4,000 August 2017 September 2017 817 — 631 186 Milestone - UK reimbursement approval 2,000 February 2018 March 2018 408 — 316 92 Milestone - German reimbursement approval 2,000 November 2018 December 2018 407 — 316 91 Milestone - Spanish reimbursement approval 2,000 February 2019 May 2019 408 — 316 92 Total $ 12,500 $ 2,552 $ — $ 1,974 $ 578 Biodesix In April 2014, the Company entered into a worldwide co-development and collaboration agreement (the “Biodesix Agreement”) with Biodesix, Inc. (“Biodesix”) to develop and commercialize ficlatuzumab, the Company’s potent humanized IgG1 monoclonal antibody that targets HGF. Under the Biodesix Agreement, prior to the first commercial sale of ficlatuzumab, each party had the right to elect to discontinue its funding obligation for further development or commercialization efforts with respect to ficlatuzumab in exchange for reduced economics in the program, which is referred to as an “Opt-Out.” In September 2020, the Company regained full global rights to ficlatuzumab, effective December 2, 2020, when Biodesix exercised its “Opt-Out” rights under the Biodesix Agreement. Pursuant to the terms of the Biodesix Agreement, as a result of Biodesix’s election to Opt-Out, Biodesix will (i) continue to be responsible for reimbursement of development costs with respect to the ongoing open label Phase 2 investigator-sponsored clinical trial of ficlatuzumab in combination with ERBITUX® (cetuximab) in HNSCC (the “Phase 2 HNSCC Trial”), (ii) cease to be entitled to 50% sharing of profits resulting from commercialization of ficlatuzumab, (iii) be entitled to a low double digit royalty on future product sales and 25% of future licensing revenue less approximately $2.5 million that Biodesix would be required to pay to the Company pursuant to the October 2016 amendment to the Biodesix Agreement and excluding contributions to research and development expenses and (iv) remain responsible for development obligations under the Biodesix Agreement with respect to VeriStrat. Biodesix and the Company also remain obligated to negotiate a commercialization agreement to delineate their rights and obligations in the event of any commercialization of VeriStrat with ficlatuzumab. As a result of Biodesix’s decision to Opt-Out, the Company now has worldwide licensing rights and sole decision-making authority with respect to further development and commercialization of ficlatuzumab. The payment obligations between the parties under the Biodesix Agreement are in effect until completion of the Phase 2 HNSCC Trial. CANbridge In March 2016, the Company entered into a collaboration and license agreement (the “CANbridge Agreement”) with CANbridge Life Sciences, Ltd. (“CANbridge”). Under the terms of the CANbridge Agreement, the Company granted CANbridge the exclusive right to develop, manufacture and commercialize AV-203, the Company’s potent humanized IgG1 monoclonal antibody that targets ErbB3 (also known as HER3), for the diagnosis, treatment and prevention of disease in all countries outside of North America. In March 2021, CANbridge exercised its right to terminate for convenience the CANbridge Agreement. Under the terms of the CANbridge Agreement, the transfer of the AV-203 program was completed in September 2021 and the Company regained worldwide rights to the AV-203 program. Biogen Idec International GmbH In March 2009, the Company entered into an exclusive option and license agreement with Biogen regarding the development and commercialization of the Company’s discovery-stage ErbB3-targeted antibodies, including AV-203, for the potential treatment and diagnosis of cancer and other diseases outside of North America (the “Biogen Agreement”). Under the Biogen Agreement, the Company was responsible for developing ErbB3 antibodies through completion of the first Phase 2 clinical trial designed in a manner that, if successful, would generate data sufficient to support advancement to a Phase 3 clinical trial. In March 2014, the Company and Biogen amended the Biogen Agreement (the “Biogen Amendment”). Pursuant to the Biogen Amendment, Biogen agreed to the termination of its rights and obligations under the Biogen Agreement, including Biogen’s option to (i) obtain a co-exclusive (with the Company) worldwide license to develop and manufacture ErbB3 targeted antibodies and (ii) obtain exclusive commercialization rights to ErbB3 products in countries in the world other than North America. As a result, the Company has worldwide rights to AV-203. Pursuant to the Biogen Amendment, the Company is obligated to use reasonable efforts to seek a collaboration partner for the purpose of funding further development and commercialization of ErbB3 targeted antibodies. The Company is also obligated to pay Biogen a percentage of milestone payments received by the Company from future partnerships after March 28, 2016 and single digit royalty payments on net sales related to the sale of ErbB3 products, if any, up to a cumulative maximum amount of $50.0 million. In-License Agreements St. Vincent’s In July 2012, the Company entered into a license agreement with St. Vincent’s, under which the Company obtained an exclusive, worldwide sublicensable right to research, develop, manufacture and commercialize products for human therapeutic, preventative and palliative applications that benefit from inhibition or decreased expression or activity of GDF15, which is also referred to as MIC-1 (the “St. Vincent’s Agreement”). Under the St. Vincent’s Agreement, St. Vincent’s also granted the Company non-exclusive rights for certain related diagnostic products and research tools. In order to sublicense certain necessary intellectual property rights to Novartis in August 2015, the Company amended and restated the St. Vincent’s Agreement and made an additional upfront payment to St. Vincent’s of $1.5 million. As of December 31, 2021, the Company is required to make future milestone payments, up to an aggregate total of $14.4 million, upon the earlier of the achievement of specified development and regulatory milestones or a specified date for the first indication, and upon the achievement of specified development and regulatory milestones for the second and third indications, for licensed therapeutic products, some of which payments may be increased by a mid to high double-digit percentage rate for milestone payments made after the Company grants any sublicense, depending on the sublicensed territory. In February 2022, the Company paid.a $2.3 million time-based milestone obligation that became due to St. Vincent’s in January 2022. The Company will also be required to pay St. Vincent’s tiered royalty payments equal to a low-single-digit percentage of any net sales it or its sublicensees make from licensed therapeutic products. The royalty rate escalates within the low-single-digit range during each calendar year based on increasing licensed therapeutic product sales during such calendar year. The St. Vincent’s Agreement remains in effect until the later of 10 years after the date of first commercial sale of licensed therapeutic products in the last country in which a commercial sale is made, or expiration of the last-to-expire valid claim of the licensed patents, unless we elect, or St. Vincent’s elects, to terminate the St. Vincent’s Agreement earlier. We have the right to terminate the St. Vincent’s Agreement on six months’ notice if we terminate our GDF15 research and development programs as a result of the failure of a licensed therapeutic product in preclinical or clinical development, or if we form the reasonable view that further GDF15 research and development is not commercially viable, and we are not then in breach of any of our obligations under the St. Vincent’s Agreement. Kyowa Kirin Co. (KKC) In December 2006, the Company entered into an agreement with KKC (the “KKC Agreement”), under which it obtained an exclusive, sublicensable license to develop, manufacture and commercialize tivozanib in all territories in the world except for Asia and the Middle East, where KKC retained the rights to tivozanib. Under the KKC Agreement, the Company obtained exclusive rights to tivozanib in its territory under certain KKC patents, patent applications and know-how for the diagnosis, prevention and treatment of all human diseases and conditions (the “Field”). On August 1, 2019, the Company entered into an amendment to the KKC Agreement pursuant to which KKC repurchased the non-oncology rights to tivozanib in the Company’s territory, excluding the rights the Company has sublicensed to EUSA under the EUSA Agreement. The Company has upfront, milestone and royalty payment obligations to KKC under the KKC Agreement related to the amended Field for oncology development by the Company, and following the amendment, KKC also has upfront, milestone and royalty payment obligations to the Company related to non-oncology development by KKC in the Company’s territory. Pursuant to the amendment to the KKC Agreement, KKC made a non-refundable upfront payment to the Company in the amount of $25.0 million that was received in September 2019, and KKC waived the one-time milestone payment of $18.0 million which would have otherwise been payable by the Company upon obtaining marketing approval on March 10, 2021 for tivozanib in the United States. KKC is required to make milestone payments to the Company of up to an aggregate of $390.7 million upon the successful achievement of certain development and sales milestones of tivozanib in non-oncology indications. KKC Agreement Upon entering into the KKC Agreement, the Company made an upfront payment in the amount of $5.0 million. In March 2010, the Company made a milestone payment to KKC in the amount of $10.0 million in connection with the dosing of the first patient in the Company’s TIVO-1 trial. In December 2012, the Company made a $12.0 million milestone payment to KKC in connection with the acceptance by the FDA of the Company’s 2012 New Drug Application filing for tivozanib. Pursuant to the amendment to the KKC Agreement, KKC waived the one-time milestone payment of $18.0 million which would have otherwise been payable by the Company upon obtaining marketing approval on March 10, 2021 for tivozanib in the United States. Each milestone under the KKC Agreement was a one-time only payment obligation. The Company has no remaining development and commercialization milestone payments due to KKC under the KKC Agreement. The Company is also required to pay tiered royalty payments on net sales it makes of tivozanib in its North American territory, which range from the low to mid-teens as a percentage of net sales. The royalty rate escalates within this range based on increasing tivozanib sales. The Company’s royalty payment obligations in a particular country in its territory begin on the date of the first commercial sale of tivozanib in that country, and end on the later of 12 years after the date of first commercial sale of tivozanib in that country or the date of the last to expire of the patents covering tivozanib that have been issued in that country. On March 10, 2021, the FDA approved FOTIVDA in the United States for the treatment of adult patients with relapsed or refractory advanced RCC following two or more prior systemic therapies. On March 22, 2021, the Company commenced product sales of FOTIVDA in the United States. In the years ended December 31, 2021, the Company recognized approximately $4.7 million in royalties due to KKC on net product sales of FOTIVDA in the United States in its Statement of Operations as a component of cost of products sold. If the Company sublicenses any of its rights to tivozanib to a third party, as it has done with EUSA, the sublicense defines the payment obligations of the sublicensee, which may vary from the milestone and royalty payment obligations under the KKC Agreement relating to rights the Company retains. The Company is required to pay KKC a fixed 30% of amounts the Company receives from its sublicensees, including upfront license fees, milestone payments and royalties, but excluding amounts the Company receives for research and development reimbursement payments or equity investments, subject to certain limitations. In connection with the EUSA Agreement, the Company is required to pay KKC the 30% sublicense fee related to earned milestone payments and royalties from EUSA. However, research and development reimbursement payments by EUSA are excluded from the 30% sublicense fee, subject to certain limitations. If EUSA elects to opt-in to the TIVO-3 trial, only approximately $8.7 million of the final $20.0 million research and development payment by EUSA would be subject to the 30% sublicense fee due to KKC. Refer to the section above, “Out License Agreements – EUSA” , for further discussion of the actual 30% sublicense fees incurred and paid to-date to KKC. T he Company and KKC each have access to and can benefit from the other party’s clinical data and regulatory filings with respect to tivozanib and biomarkers identified in the conduct of activities under the KKC Agreement, as related to the amended Field for oncology development. Under the KKC Agreement, the Company is obligated to use commercially reasonable efforts to develop and commercialize tivozanib in its territory. The KKC Agreement will remain in effect until the expiration of all of the Company’s royalty and sublicense revenue obligations, determined on a product-by-product and country-by-country basis, unless terminated earlier. If the Company fails to meet its obligations under the KKC Agreement and is unable to cure such failure within specified time periods, KKC can terminate the KKC Agreement, resulting in a loss of our rights to tivozanib and an obligation to assign or license to KKC any intellectual property or other rights the Company may have in tivozanib, including its regulatory filings, regulatory approvals, patents and trademarks for tivozanib. August 1, 2019 Amendment to the KKC Agreement In addition to the non-refundable upfront payment to the Company pursuant to the amendment to the KKC Agreement in the amount of $25.0 million and the waiver of the $18.0 million milestone for United States approval of tivozanib, the Company earned and received a $2.8 million development milestone payment in August 2020 pursuant to the amendment to the KKC Agreement upon the acceptance of KKC’s investigational new drug, or IND, application for a non-oncology use of tivozanib by the Pharmaceuticals and Medical Devices Agency of Japan on August 2, 2020. KKC is also required to make remaining milestone payments to the Company of up to an aggregate of $387.9 million upon the successful achievement of certain development and sales milestones of tivozanib in non-oncology indications. KKC is required to make tiered royalty payments to the Company on net sales of tivozanib in non-oncology indications in the Company’s territory, which range from high single digit to low double digits as a percentage of net sales. The royalty rate escalates within this range based on increasing tivozanib sales, subject to certain adjustments. KKC’s royalty payment obligations in a particular country in the Company’s territory begin on the date of the first commercial sale of tivozanib in that country, and end on the later of the expiration date of the last valid claim of a patent application or patent owned by KKC covering tivozanib or 10 years after the date of first commercial sale of tivozanib in non-oncology indications in that country. No milestone payments were earned in the year ended December 31, 2021. During the year ended December 31, 2020, the Company received a $2.8 million development milestone payment. If KKC sublicenses any of its rights to tivozanib to a third-party, KKC is required to pay the Company a percentage of amounts received from the respective sublicensees related to the Company’s territory, including upfront license fees, milestone payments and royalties, but excluding amounts received in respect of research and development reimbursement payments or equity investments, subject to certain limitations. Accounting Analysis Under the August 1, 2019 Amendment to the KKC Agreement Following the repurchase of non-oncology rights by KKC, the amended KKC Agreement is accounted for as two distinct agreements: (i) the KKC Agreement by which the Company has upfront, milestone and royalty payment obligations to KKC related to the Company’s oncology development of tivozanib in the amended Field for the Company’s territory that continues to be accounted for under ASC 730, Research and Development, and (ii) the amended KKC Agreement by which KKC has upfront, milestone and royalty payment obligations to the Company related to its non-oncology development of tivozanib for the Company’s territory that will be accounted for under ASC 606 . The Company evaluated the amendment to the KKC Agreement under ASC 606 and determined that KKC met the definition of a “Customer” as the Company considers the licensing or sale of intellectual property rights to be an output of the Company’s ordinary activities and is central to the operations of the Company. The Company determined that the amendment to the KKC Agreement contained a single performance obligation related to the Company’s transfer of rights to non-oncology intellectual property and know-how to KKC, excluding the rights the Company has sublicensed to EUSA under the EUSA Agreement. In addition, the Company determined that the $25.0 million non-refundable upfront payment received from KKC in September 2019 constituted the amount of the consideration to be included in the transaction price and attributed this amount to the Company’s single performance obligation. The Company satisfied this performance obligation during the third quarter of 2019. Accordingly, the Company recognized the $25.0 million in consideration as revenue in the third quarter of 2019. The Company concluded the performance obligation was satisfied at a point in time because any know-how or clinical data generated from the Company’s ongoing oncology development of tivozanib would not benefit KKC’s non-oncology development of tivozanib. In the third quarter of 2020, the Company increased the transaction price to $27.8 million to include the $2.8 million development milestone that was earned in August 2020 upon the acceptance of KKC’s IND application for a non-oncology use of tivozanib by the Pharmaceuticals and Medical Devices Agency of Japan. Accordingly, the Company recognized the $2.8 million in consideration as revenue in the third quarter of 2020 as the Company did not have any ongoing performance obligations under the amendment to the KKC Agreement. None of KKC’s remaining development and regulatory milestones to the Company related to its non-oncology development of tivozanib for the Company’s territory were included in the transaction price, as these milestone amounts were fully constrained. As part of its evaluation of the constraint, the Company considered multiple factors: (i) regulatory approvals are outside of the control of KKC; (ii) certain development and regulatory milestones are contingent upon the success of future clinical trials, if any, which is out of the control of KKC; and (iii) efforts by KKC. Any consideration related to development and regulatory milestones owed by KKC to the Company will be recognized when the corresponding milestones are no longer constrained as the Company does not have any ongoing performance obligations. 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 intellectual property transferred to KKC and therefore are recognized at the later of when the performance obligation is satisfied or the related sales occur. |
Other Accrued Liabilities
Other Accrued Liabilities | 12 Months Ended |
Dec. 31, 2021 | |
Accrued Liabilities, Current [Abstract] | |
Other Accrued Liabilities | Other Accrued Liabilities Other accrued expenses consisted of the following (in thousands): December 31, December 31, FOTIVDA U.S. Product Royalties 2,011 — FOTIVDA Federal Rebates, Customer Credits and Co-Pay Assistance 1,170 — Professional Fees 1,107 1,061 Other 1,133 320 Total 5,421 1,381 |
Hercules Loan Facility
Hercules Loan Facility | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
Hercules Loan Facility | Hercules Loan Facility On May 28, 2010, the Company entered into a loan and security agreement (the “First Loan Agreement”) with Hercules Capital Inc. and certain of its affiliates (“Hercules”). The First Loan Agreement was subsequently amended in March 2012, September 2014, May 2016 and amended and restated in December 2017 (the “2017 Loan Agreement” and as amended by the 2020 Loan Amendment (as defined below) and the 2021 Loan Amendment (as defined below), the “Loan Agreement”). On August 7, 2020, the Company entered into a first amendment to the 2017 Loan Agreement (the “2020 Loan Amendment”) to provide the Company , subject to certain terms and conditions, with an additional term loan in an aggregate principal amount of up to $35.0 million (the “2020 Loan Facility”) in up to four tranches to be used to refinance outstanding loans under the 2017 Loan Agreement, and for general working capital purposes. The Company received the initial $15.0 million of the 2020 Loan Facility upon the closing of the 2020 Loan Amendment, of which approximately $9.7 million was used to retire the then outstanding balance under the 2017 Loan Agreement and of which approximately $5.3 million was new loan funding which was used for general working capital purposes. The remainder of the loan amount is available to the Company, at its option, subject to certain terms and conditions, including upon the achievement of the following milestones: (i) the second tranche in the initial amount of $10.0 million (“Tranche Two”) was available through June 30, 2021 upon achieving FDA approval of FOTIVDA (“Performance Milestone I”), (ii) the third tranche of $5.0 million (“Tranche Three”) was initially available from July 1, 2021 through January 31, 2022 assuming the Company was to achieve $20.0 million in net product revenues from sales of FOTIVDA, by no later than December 31, 2021 (“Performance Milestone II”), and (iii) the fourth tranche of $5.0 million (“Tranche Four”) was initially available through June 30, 2022 contingent upon the achievement of both Performance Milestone I and Performance Milestone II, and subject to the consent of Hercules. The 2020 Loan Amendment also amended the 2017 Loan Agreement by: (i) extending maturity until September 1, 2023, which is extendable to September 1, 2024 at the Company’s option assuming the Tranche Three funding has occurred, (ii) providing for an interest-only period beginning on the closing date of 2020 Loan Amendment and ending on September 30, 2021, which period may be extended through September 30, 2022 provided the Company achieves Performance Milestone I and further extendable through March 31, 2023 after the Tranche Three funding has occurred, if at all, and (iii) revising the per annum interest rate to the greater of (x) 9.65% and (y) an amount equal to 9.65% plus the prime rate as reported in the Wall Street Journal minus 3.25% as determined daily, provided however, that the per annum interest rate shall not exceed 15%. Principal payments were scheduled to commence on October 1, 2021 at the earliest, as described above. The interest rate as of December 31, 2021 was 9.65%. Per the terms of the 2020 Loan Facility, principal will be repaid in equal monthly installments following the conclusion of the interest-only period. The Company may prepay all of the outstanding principal and accrued interest under the 2020 Loan Facility, subject to a prepayment charge up to 3.0% in the first year following the closing of the 2020 Loan Amendment, decreasing to 2.0% in year two and 1.0% in year three. The Company is obligated to make an end-of-term payment of 6.95% of the aggregate amount of loan funding received under the 2020 Loan Facility on the earlier of the maturity of the loan or the date on which the Company prepays any outstanding loan balance. The approximate $0.8 million end-of-term payment under the 2017 Loan Agreement continued to be due and was paid on July 1, 2021. In connection with the 2020 Loan Amendment, the Company incurred approximately $0.3 million in loan issuance costs paid directly to Hercules, which are accounted for as a loan discount. The 2020 Loan Amendment was accounted for as a loan modification in accordance with ASC 470-50. The 2020 Loan Facility includes various financial and operating covenants, including that the Company maintain an unrestricted cash position of at least $10.0 million through the date the Third Tranche funding is received and at least $5.0 million thereafter through the maturity of the loan. The Company was also required to achieve greater than or equal to 75% of its forecasted net product revenues from its sales of tivozanib over a six month trailing period, as defined and measured on a monthly basis, effective upon the earlier of receiving Third Tranche funding and the month of April 2022. On February 1, 2021, the Company entered into the second amendment to the 2017 Loan Agreement (the “2021 Loan Amendment”), which increased the 2020 Loan Facility from up to $35.0 million to up to $45.0 million following FDA approval of FOTIVDA. The 2021 Loan Amendment makes certain changes to the 2020 Loan Amendment, including, among other things, (i) increasing Tranche Two funding upon achieving Performance Milestone I from $10.0 million to $20.0 million, thereby increasing the total amount of then unfunded term loan commitments under the 2020 Loan Facility from $20.0 million to $30.0 million, (ii) increasing the amount of net product revenues from sales of FOTIVDA required to achieve Performance Milestone II from $20.0 million to $35.0 million and changing the deadline for achieving Performance Milestone II from December 31, 2021 to April 1, 2022 and (iii) increasing the amount of the financial covenant for the maintenance of an unrestricted cash position from at least $10.0 million to at least $15.0 million from the date the Tranche Two funding is received until the date the Tranche Three funding is received and at least $10.0 million thereafter through the maturity of the Loan Agreement. In connection with the 2021 Loan Amendment, the Company incurred approximately $0.1 million in loan issuance costs paid directly to Hercules, which are accounted for as a loan discount. On March 11, 2021, the Company completed the $20.0 million drawdown of Tranche Two funding under the 2021 Loan Amendment that was made available in connection with the achievement of Performance Milestone I upon FDA approval of FOTIVDA on March 10, 2021. The achievement of Performance Milestone I extended the interest-only period by twelve months from September 30, 2021 to September 30, 2022 and increased the amount of unrestricted cash required for the Company to satisfy the minimum financial covenant during the period between receiving Tranche Two funding and Tranche Three funding from $10.0 million to $15.0 million. On December 22, 2021, the Company completed the $5.0 million drawdown of Tranche Three funding under the 2021 Loan Amendment that was made available in connection with the achievement of Performance Milestone II upon the achievement of $35.0 million in net product revenues from sales of FOTIVDA. The achievement of Performance Milestone II extended the interest-only period by six months from September 30, 2022 to March 31, 2023, extended the loan maturity by one year from September 1, 2023 to September 1, 2024 and decreased the amount of unrestricted cash required for the Company to satisfy the minimum financial covenant from $15.0 million to $10.0 million thereafter through the maturity of the Loan Agreement. As of December 31, 2021, the total principal balance was $40.0 million, principal payments are scheduled to commence on April 1, 2023 and the corresponding end-of-term payments under the 2020 Loan Facility, in the aggregate amount of approximately $2.8 million, are due upon the current loan maturity date of September 1, 2024. As of December 31, 2021, $5.0 million remains available to the Company in committed funding under the 2020 Loan Facility, in Tranche Four funding that was at our election and subject to the consent of Hercules. The unamortized discount to be recognized over the remainder of the loan period was approximately $2.0 million and $1.2 million as of December 31, 2021 and December 31, 2020, respectively. Per the 2017 Loan Agreement, the end-of-term payment of approximately $0.8 million was paid on July 1, 2021, as scheduled. On March 8, 2022, the Company entered into the 2022 Loan Amendment. The 2022 Loan Amendment (i) changed the operating covenant to decrease the achievement of greater than or equal to 75% of the Company's forecasted net product revenues from its sales of tivozanib over a six-month trailing period to 65%, as defined an d measured on a monthly basis, and extended the month of commencement from April 2022 to June 2022, (ii) added a cash waiver, at the Company's election, in the event its actual net product revenues from its sales of tivozanib over a six-month trailing period are below the monthly minimum operating covenant of 65% , such that the Company's unrestricted cash position is equal to or greater than the then total outstanding principal under the Loan Agreement for each day of such month, (iii) changed Tranche Four funding, in the amount of $5.0 million, that was subject to the consent of Hercules to the achievement of $30.0 million in net product revenues from sales of FOTIVDA over a trailing three-month period, or Performance Milestone III, and extended the availability of Tranche Four funding from June 30, 2022 to December 15, 2022, and (iv) increased the amount of unrestricted cash required for the Company to satisfy the minimum financial covenant from $10.0 million to $15.0 million upon the earlier of receiving the Tranche Four funding or January 1, 2023, through the maturity of the Loan Agreement. The 2020 Loan Facility is secured by substantially all of the Company’s assets, excluding intellectual property. The 2020 Loan Facility provides that certain events shall constitute a default by the Company, including failure by the Company to pay amounts under the 2020 Loan Amendment when due; breach or default in the performance of any covenant under the 2020 Loan Amendment by the Company, subject to certain cure periods; insolvency of the Company and certain other bankruptcy proceedings involving the Company; default by the Company of obligations involving indebtedness in excess of $500,000; and the occurrence of an event or circumstance that would have a material adverse effect upon the business of the Company. As of December 31, 2021, the Company was in compliance with all loan covenants, Hercules has not asserted any events of default and the Company does not believe that there has been a material adverse effect as defined in the 2020 Loan Amendment. The Company has determined that the risk of subjective acceleration under the material adverse events clause is remote and therefore has classified the outstanding principal as a long-term liability based on the timing of scheduled principal payments. Future minimum payments under the loans payable outstanding as of December 31, 2021 are as follows (in thousands): Year Ending December 31: Amount 2022 $ 3,885 2023 22,528 2024 24,406 $ 50,819 Less amount representing interest (8,039) Less unamortized discount (2,040) Less deferred charges (2,780) Less loans payable current, net of discount — Loans payable, net of current portion and discount $ 37,960 |
Common Stock
Common Stock | 12 Months Ended |
Dec. 31, 2021 | |
Equity [Abstract] | |
Common Stock | Common Stock As of December 31, 2021, the Company had 50,000,000 authorized shares of common stock, $0.001 par value, of which 34,474,710 shares were issued and outstanding. Public Offering – March 2021 On March 26, 2021, the Company completed an underwritten public offering of 6,900,000 shares of its common stock, including the full exercise by the underwriters of their option to purchase an additional 900,000 shares, at the public offering price of $8.00 per share for gross proceeds of approximately $55.2 million. The net offering proceeds to the Company were approximately $51.7 million after deducting underwriting discounts and commissions and estimated offering expenses payable by the Company. Universal Shelf Registration Statement On November 9, 2020, the Company filed a shelf registration statement on Form S-3 with the SEC, which covers the offering, issuance and sale of up to $300.0 million of its common stock, preferred stock, debt securities, warrants and/or units (the “2020 Shelf”). The 2020 Shelf (File No. 333-249982) was declared effective by the SEC on November 18, 2020 and was filed to replace the Company’s then existing shelf registration statement, which was terminated. As of December 31, 2021, there was approximately $213.0 million available for future issuance of common stock, preferred stock, debt securities, warrants and/or units. Public Offering – June 2020 On June 19, 2020, the Company completed an underwritten public offering of 9,725,000 shares of its common stock, including the partial exercise by the underwriters of their option to purchase an additional 1,225,000 shares, at the public offering price of $5.25 per share for gross proceeds of approximately $51.1 million. Three stockholders beneficially holding more than 5% of the Company’s voting securities, including an entity affiliated with New Enterprise Associates and two other stockholders, purchased an aggregate of 4,503,571 shares in this offering at the same public offering price per share as the other investors. At such time, entities affiliated with New Enterprise Associates (collectively) beneficially held more than 5% of the Company’s voting securities. The net offering proceeds to the Company were approximately $47.7 million after deducting underwriting discounts and commissions and estimated offering expenses payable by the Company. Reverse Stock Split – February 2020 On February 13, 2020, the holders of a majority of the Company’s outstanding shares of common stock approved the reverse stock split and gave the Company’s board of directors discretionary authority to select a ratio for the split ranging from 1-for-5 to 1-for-15. The Company’s board of directors approved the reverse stock split at a ratio of 1-for-10 on February 13, 2020. On February 19, 2020, the Company effected a reverse stock split of its outstanding shares of common stock at a ratio of one-for-ten pursuant to a Certificate of Amendment to its Certificate of Incorporation filed with the Secretary of State of the State of Delaware. The reverse stock split was reflected on Nasdaq beginning with the opening of trading on February 20, 2020. The primary purpose of the reverse stock split was to enable the Company to regain compliance with the $1.00 minimum bid price requirement for continued listing on Nasdaq. The reverse stock split affected all issued and outstanding shares of the Company’s common stock, as well as the number of authorized shares of the Company’s common stock and the number of shares of common stock available for issuance under the Company’s equity incentive plans. The reverse stock split reduced the number of shares of the Company’s issued and outstanding common stock from approximately 160.8 million to approximately 16.1 million. In addition, the reverse stock split effected a reduction in the number of shares of the Company’s common stock issuable upon the exercise of stock options and warrants outstanding immediately prior to the reverse stock split, with a proportional increase in the respective exercise prices. The reverse stock split proportionately reduced the number of authorized shares of the Company’s common stock from 500.0 million shares to 50.0 million. The reverse stock split did not change the par value of the Company’s common stock or the authorized number of shares of the Company’s preferred stock. All share and per share amounts give effect to the reverse stock split on a retroactive basis. Expired Offering Warrants from April 2019 Public Offering – Expiration Date of April 8, 2021 In April 2019, the Company completed an underwritten public offering of 2,173,913 shares of its common stock and warrants to purchase an aggregate of 2,500,000 shares of its common stock (“the Offering Warrants”), including warrants to purchase an aggregate of 326,086 shares of its common stock sold pursuant to the underwriter’s partial exercise of its overallotment option, at the public offering price of $11.40 per share and $0.10 per warrant for gross proceeds of approximately $25.0 million. The Offering Warrants were immediately exercisable upon issuance at an exercise price of $12.50 per share, subject to adjustment in certain circumstances, and expired two years from the date of issuance on April 8, 2021. Any Offering Warrants that had not been exercised for cash prior to their expiration were to be automatically exercised via cashless exercise on the expiration date. The shares and warrants were issued separately and were separately transferable. An entity affiliated with New Enterprise Associates purchased 434,782 shares and warrants to purchase an aggregate of 434,782 shares in this offering at the same public offering price per share as the other investors. At such time, entities affiliated with New Enterprise Associates (collectively) beneficially held more than 5% of the Company’s voting securities. The net offering proceeds to the Company were approximately $22.8 million after deducting underwriting discounts and commissions and estimated offering expenses payable by the Company. The Company determined the shares of common stock and the Offering Warrants represented freestanding financial instruments. In addition, the Company conducted an assessment of the classification of the Offering Warrants and, based on their terms, concluded the Offering Warrants were equity-classified. Accordingly, the net offering proceeds of $22.8 million were recorded within stockholders’ equity (deficit). Public Offering – April 2019 In April 2019, the Company completed an underwritten public offering of 2,173,913 shares of its common stock and warrants to purchase an aggregate of 2,500,000 shares of its common stock (“the 2019 Offering Warrants”), including warrants to purchase an aggregate of 326,086 shares of its common stock sold pursuant to the underwriter’s partial exercise of its overallotment option, at the public offering price of $11.40 per share and $0.10 per warrant for gross proceeds of approximately $25.0 million. The 2019 Offering Warrants were immediately exercisable upon issuance at an exercise price of $12.50 per share, subject to adjustment in certain circumstances, and will expire two years from the date of issuance upon their scheduled expiration on April 8, 2021. Any 2019 Offering Warrants that have not been exercised for cash prior to their expiration shall be automatically exercised via cashless exercise on the expiration date. The shares and warrants were issued separately and are separately transferable. An entity affiliated with New Enterprise Associates purchased 434,782 shares and warrants to purchase an aggregate of 434,782 shares in this offering at the same public offering price per share as the other investors. At such time, entities affiliated with New Enterprise Associates (collectively) beneficially held more than 5% of the Company’s voting securities. The net offering proceeds to the Company were approximately $22.8 million after deducting underwriting discounts and commissions and estimated offering expenses payable by the Company. As of December 31, 2020, 2019 Offering Warrants to purchase 2,500,000 shares of the Company’s common stock were outstanding. The Company determined the shares of common stock and the 2019 Offering Warrants represented freestanding financial instruments. In addition, the Company conducted an assessment of the classification of the Offering Warrants and, based on their terms, concluded the 2019 Offering Warrants are equity-classified. Accordingly, the net offering proceeds of $22.8 million have been recorded within stockholders’ equity (deficit) . In March 2021, 2019 Offering Warrants exercisable for 247,391 shares of common stock were exercised for approximately $3.1 million in cash proceeds. On April 8, 2021, all of the remaining 2,252,609 2019 Offering Warrants expired and no shares of the Company’s common stock were issued via automatic cashless exercises of unexercised 2019 Offering Warrants on the date of expiration as the $12.50 exercise price was greater than the Company’s closing stock price of $7.01 on April 8, 2021. Sales Agreement with SVB Leerink In February 2018, the Company entered into a sales agreement with SVB Leerink LLC (“SVB Leerink” and the “SVB Leerink Sales Agreement”) pursuant to which the Company may issue and sell shares of its common stock from time to time up to an aggregate amount of $50.0 million, at its option, through SVB Leerink as its sales agent, with any sales of common stock through SVB Leerink being made by any method that is deemed an “at-the-market offering” as defined in Rule 415 promulgated under the Securities Act of 1933, as amended (the “Securities Act”), or in other transactions pursuant to an effective shelf registration statement on Form S-3. The Company agreed to pay SVB Leerink a commission of up to 3% of the gross proceeds of any sales of common stock pursuant to the SVB Leerink Sales Agreement. The Company sold 470,777 shares, 1,251,555 shares, 1,070,175 shares and 330,688 shares pursuant to the SVB Leerink Sales Agreement, resulting in proceeds net of commissions of approximately $10.3 million, $7.5 million, $5.9 million and $3.4 million in the fourth quarter of 2018, February 2019, November 2020 and March 2021, respectively. As of December 31, 2021, approximately $22.2 million was available for issuance in connection with future stock sales pursuant to the SVB Leerink Sales Agreement. Expired PIPE Warrants from May 2016 Private Placement – Expiration Date of May 16, 2021 In May 2016, the Company entered into a securities purchase agreement with a select group of qualified institutional buyers, institutional accredited investors and accredited investors pursuant to which the Company sold 1,764,242 units, at a price of $9.65 per unit, for gross proceeds of approximately $17.0 million. Each unit consisted of one share of the Company’s common stock and a warrant to purchase one share of the Company’s common stock (the “PIPE Warrants”). The PIPE Warrants had an exercise price of $10.00 per share and expired five years from the date of issuance on May 16, 2021. Certain of the Company’s directors and executive officers purchased an aggregate of 54,402 units in this offering at the same price as the other investors. The net offering proceeds to the Company were approximately $15.4 million after deducting placement agent fees and other offering expenses payable by the Company. PIPE Warrants exercisable for 80,309 shares of common stock had been exercised for approximately $0.8 million in cash proceeds and all of the remaining 1,683,933 PIPE Warrants expired on May 16, 2021. |
Stock-based Compensation
Stock-based Compensation | 12 Months Ended |
Dec. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Stock-based Compensation | Stock-based Compensation Stock Incentive Plan The Company previously maintained the 2010 Stock Incentive Plan (the “2010 Plan”) for employees, consultants, advisors and directors, as amended in March 2013, June 2014 and June 2017. In April 2019, the Company’s board of directors adopted the 2019 Equity Incentive Plan (the “2019 Plan”) and on June 12, 2019 the stockholders approved the 2019 Plan at the Annual Meeting of Stockholders. The 2019 Plan provides similar terms as the 2010 Plan, including: (i) a provision for the grant of equity awards such as stock options and restricted stock; (ii) that the exercise price of incentive stock options cannot be less than 100% of the fair market value of the common stock on the date of the grant for participants who own less than 10% of the total combined voting power of stock of the Company and not less than 110% for participants who own more than 10% of the total combined voting power of the stock of the Company; (iii) that options and restricted stock granted under the 2019 Plan vest over periods as determined by the board of directors, which generally are equal to four years; and (iv) that options granted under the 2019 Plan expire over periods as determined by the board of directors, which generally are ten years from the date of grant. In April 2020, the board of directors adopted an amendment to the 2019 Plan to increase the total number of shares reserved under the Plan by 1,300,000 shares, among other things. This amendment was approved by stockholders at the Annual Meeting of Stockholders held on June 10, 2020. In April 2021, the board of directors adopted an additional amendment to the 2019 Plan to increase the total number of shares reserved under the Plan by 2,200,000. This amendment was approved by stockholders at the Annual Meeting of Stockholders held on June 9, 2021. Awards may be made under the 2019 Plan for up to the sum of (i) 4,500,000 shares of common stock and (ii) such additional number of shares of common stock (up to 1,068,901 shares) as is equal to (x) the number of shares of common stock reserved for issuance under the 2010 Plan that were available for grant under the 2010 Plan immediately prior to the date the 2019 Plan was approved by the Company’s stockholders and (y) the number of shares of common stock subject to awards outstanding under the 2010 Plan, which awards expire, terminate or are otherwise surrendered, cancelled, forfeited or repurchased by the Company pursuant to a contractual repurchase right. As of December 31, 2021, there were 2,401,114 shares of common stock available for future issuance under the 2019 Plan and no shares of common stock available for future issuance under the 2010 Plan. The following table summarizes stock option activity during the year ended December 31, 2021: Options Weighted- Average Exercise Price Weighted- Average Remaining Contractual Term Aggregate Intrinsic Value Outstanding at January 1, 2021 1,816,690 $ 11.04 7.53 $ 170,000 Granted 1,751,218 8.37 Exercised (2,479) 5.97 Forfeited (409,050) 11.87 Outstanding at December 31, 2021 3,156,379 $ 9.45 7.55 $ 5,720 Exercisable at December 31, 2021 1,357,101 $ 11.72 5.82 $ 1,907 The aggregate intrinsic value is based upon the Company’s closing stock price of $4.69 on December 31, 2021. The fair value of stock options, subject only to service or performance conditions, that are granted to employees is estimated on the date of grant using the Black-Scholes option-pricing model. The following tables summarize the assumptions used in the Black-Scholes option-pricing model in the years ended December 31, 2021, 2020 and 2019: Years Ended 2021 2020 2019 Volatility factor 56.17% - 102.66% 94.37% - 102.48% 88.27% - 98.81% Expected term (in years) 0.25 - 6.25 5.50 - 6.25 5.50 - 6.25 Risk-free interest rates 0.06% - 1.33% 0.31% - 1.67% 1.43% - 2.55% Dividend yield — — — Based upon these assumptions, the weighted-average grant date fair value of stock options granted during the years ended December 31, 2021, 2020 and 2019 was $6.49, $4.54 and $5.70 respectively. As of December 31, 2021, there was $10.1 million of total unrecognized stock-based compensation expense related to stock options granted to employees under the Plan. The expense is expected to be recognized over a weighted-average period of 2.88 years . The intrinsic value of options exercised was a nominal amount in the years ended December 31, 2021, 2020 and 2019, respectively. Employee Stock Purchase Plan In February 2010, the board of directors adopted the 2010 Employee Stock Purchase Plan (the “ESPP”), as amended in March 2013 and in November 2017. In April 2021, the board of directors adopted an amendment to the 2010 ESPP Plan to increase the total number of shares reserved under the Plan by 500,000 shares, pursuant to which the Company may sell up to an aggregate of 576,400 shares of Common Stock. This amendment was approved by stockholders at the Annual Meeting of Stockholders held on June 9, 2021. The ESPP allows eligible employees to purchase common stock at a price per share equal to 85% of the lower of the fair market value of the common stock at the beginning or end of each six-month period during the term of the ESPP. As of December 31, 2021, there were 412,403 shares available for future issuance under the ESPP. Pursuant to the ESPP, the Company sold a total of 111,456 shares of common stock during the year ended December 31, 2021 at purchase prices of $4.38 and $4.40, which represents 85% of the closing price of the Company’s common stock on December 1, 2020 and December 14, 2021. The Company sold a total of 5,971 shares of common stock during the year ended December 31, 2020 at purchases prices of $6.46 and $4.57, which represents 85% of the closing price of the Company’s common stock on December 1, 2019 and November 30, 2020, respectively. The Company did not sell any shares of common stock pursuant to the ESPP during the year ended December 31, 2019. The total stock-based |
Commitment and Contingencies
Commitment and Contingencies | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Operating Leases On March 5, 2020, the Company entered into the Winter Street Sublease to relocate the Company’s corporate headquarters previously located at One Broadway in Cambridge, Massachusetts for $47.00 per square foot, or approximately $0.5 million per year in base rent, subject to certain operating expenses, taxes and annual base rent increases of approximately 3%. On November 17, 2021, the Company amended the Winter Street Sublease to reduce the square feet of office space from 10,158 square feet to 6,465 square feet. The amended Winter Street Sublease provided that (i) the security deposit of $0.3 million would be applied toward the remaining base rent payable to the landlord to satisfy in full the base rent obligations through the expiration date of November 29, 2022 and (ii) the landlord would make renovations to improve the space. The amended Winter Street Sublease term remained the same and continues through November 29, 2022. Previously, the Company leased office space under a month-to-month lease. Rent expense under the operating leases amounted to $0.6 million, $0.6 million and $0.8 million for the years ended December 31, 2021, 2020 and 2019, respectively. Manufacturing Commitments The Company has entered into a contract with a clinical manufacturing organization (“CMO”) for the manufacture of tivozanib (FOTIVDA) in the United States, which includes minimum annual purchase requirements in the range of $0.5 million to $1.4 million through 2028. In addition, the Company has a contract with a second CMO for the manufacture of clinical drug supply for ficlatuzumab and AV-380, for which the Company has manufacturing commitments in 2022 in the aggregate amount of approximately $9.0 million. Additionally, the Company has license fee obligations of up to $2.0 million due to a former CMO for ficlatuzumab drug manufacturing. Employment Agreements On March 8, 2021, the Company adopted the Executive Severance and Change in Control Benefits Plan (the "Severance Benefits Plan") for certain of our employees, including each of our executive officers. The severance benefits provided in the Severance Benefits Plan supersede the separation benefits provided under the terms of any covered employee’s severance and change in control agreement and our Key Employee Change in Control Benefits Plan. Under the terms of the Severance Benefits Plan, if the executive’s employment is terminated without cause or if the executive terminates his employment for good reason, such executive will be entitled to receive severance equal to his or, her base salary, benefits and prorated bonuses for a period of time equal to 12 months or, for the chief executive officer base salary for a period of time equal to 12 months and a bonus amount subject to a specified calculation. In addition, if any covered employee’s employment is terminated by the Company without cause or by the employee for good reason on the date of or within 18 months following a change of control, such covered employee will be entitled to receive severance for a period of time ranging from 9 months to 24 months, depending upon the position of the covered employee. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes The Company accounts for income taxes under the provisions of ASC 740. The Company recorded no tax provision for the years ended December 31, 2021 and 2020, respectively, due to generating taxable losses in all filing jurisdictions. A reconciliation of the expected income tax benefit computed using the federal statutory income tax rate to the Company’s effective income tax rate is as follows for the years ended December 31, 2021, 2020 and 2019: Years Ended December 31, 2021 2020 2019 Income tax computed at federal statutory tax rate 21.0 % 21.0 % 21.0 % State taxes, net of federal benefit 3.6 % 6.7 % 1.3 % Research and development credits 1.6 % 1.5 % (4.2) % PIPE Warrants 0.1 % 2.9 % (25.9) % Other permanent differences (0.9) % (0.5) % 1.8 % Other (0.5) % (1.1) % 5.7 % Change in valuation allowance (24.9) % (30.5) % 0.3 % Total — % — % — % With limited exceptions, the Company has incurred net operating losses from inception. At December 31, 2021 the Company had domestic federal, state, and United Kingdom (UK) net operating loss carryforwards of approximately $613.1 million, $508.4 million, and $6.0 million respectively, available to reduce future taxable income. The federal net operating loss carryforwards expire beginning in 2022 and continue through 2037 and the state loss carryforwards begin to expire in 2030 and continue through 2041. The Company’s federal net operating losses include $110.5 million, which do not expire. The foreign net operating loss carryforwards in the UK does not expire. The Company also had federal and state research and development tax credit carryforwards of approximately $12.7 million and $4.3 million, respectively, available to reduce future tax liabilities and which expire at various dates. The federal credits expire beginning in 2023 through 2040 and the state credits expire beginning in 2022 through 2036. The net operating loss and research and development carryforwards are subject to review and possible adjustment by the Internal Revenue Service and may be limited in the event of certain changes in the ownership interest of significant stockholders. The Company’s net deferred tax assets as of December 31, 2021 and 2020 are as follows (in thousands): December 31, 2021 2020 (in thousands) Deferred tax assets: NOL carryforwards $ 160,833 $ 148,689 Research and development credits 16,088 15,271 Deferred revenue and R&D reimbursements 149 742 Other temporary differences 5,930 5,001 Total deferred tax assets: 183,000 169,703 Valuation allowance (183,000) (169,703) Total $ — $ — A full valuation allowance has been recorded in the accompanying consolidated financial statements to offset these deferred tax assets because the future realizability of such assets is uncertain. This determination is based primarily on the Company’s historical and expected future losses. The valuation allowance increased by $13.3 million and $10.9 million during the years ended December 31, 2021 and 2020, respectively, which was primarily due to the generation of net operating losses and tax credits. The Company applies the provisions of ASC 740, Income Taxes , for the financial statement recognition, measurement, presentation and disclosure of uncertain tax positions taken or expected to be taken in income tax returns. Unrecognized tax benefits represent tax positions for which reserves have been established. A full valuation allowance has been provided against the Company’s deferred tax assets, so that the effect of the unrecognized tax benefits is to reduce the gross amount of the deferred tax asset and the corresponding valuation allowance. Since the Company has incurred net operating losses since inception, it has never been subject to a revenue agent review. The Company is currently open to examination under the statute of limitations by the Internal Revenue Service and state jurisdictions for the tax years ended 2018 through 2021. Carryforward tax attributes generated in years past may still be adjusted upon future examination if they have or will be used in a future period. The Company is currently not under examination by the Internal Revenue Service or any other jurisdictions for any tax years. Utilization of the net operating loss carryforwards and research and development tax credit carryforwards may be subject to an annual limitation under Section 382 of the Internal Revenue Code of 1986, as amended (the “Internal Revenue Code”), and corresponding provisions of state law, due to ownership changes that have occurred previously or that could occur in the future. These ownership changes may limit the amount of carryforwards that can be utilized annually to offset future taxable income. In general, an ownership change, as defined by Section 382, results from transactions increasing the ownership of certain shareholders or public groups in the stock of a corporation by more than 50% over a three-year period. The Company has not recently conducted a study to assess whether a change of control has occurred or whether there have been multiple changes of control since the last study was completed due to the significant complexity and cost associated with such a study. If the Company has experienced a change of control, as defined by Section 382, at any time since the last study was completed, utilization of the net operating loss carryforwards or research and development tax credit carryforwards would be subject to an annual limitation under Section 382, which is determined by first multiplying the value of the Company’s stock at the time of the ownership change by the applicable long-term tax-exempt rate, and then could be subject to additional adjustments, as required. Any limitation may result in expiration of a portion of the net operating loss carryforwards or research and development tax credit carryforwards before utilization. The Company may from time to time be assessed interest or penalties by major tax jurisdictions. The Company recognizes interest and penalties related to uncertain tax positions in income tax expense. No interest and penalties have been recognized by the Company to date. The Company anticipates that the amount of unrecognized tax benefits recorded will not change in the next twelve months. The following is a reconciliation of the Company’s gross uncertain tax positions at December 31, 2021, 2020 and 2019: Years Ended December 31, 2021 2020 2019 (in thousands) Amount established upon adoption $ 1,078 $ 1,200 $ 1,200 Additions for current year tax provisions — — — Additions for prior year tax provisions — — — Reductions of prior year tax provisions (113) (122) — Balance as of end of year $ 965 $ 1,078 $ 1,200 |
Employee Benefit Plan
Employee Benefit Plan | 12 Months Ended |
Dec. 31, 2021 | |
Retirement Benefits [Abstract] | |
Employee Benefit Plan | Employee Benefit Plan In 2002, the Company established the AVEO Pharmaceuticals, Inc. 401(k) Plan (the “401(k) Plan”) for its employees, which is designed to be qualified under Section 401(k) of the Code. Eligible employees are permitted to contribute to the 401(k) Plan within statutory and 401(k) Plan limits. The Company makes matching contributions of 50% of the first 5% of employee contributions. The Company made matching contributions of $0.3 million, $0.1 million and $0.1 million for each of the years ended December 31, 2021, 2020 and 2019, respectively. |
Quarterly Results (Unaudited)
Quarterly Results (Unaudited) | 12 Months Ended |
Dec. 31, 2021 | |
Quarterly Financial Information Disclosure [Abstract] | |
Quarterly Results (Unaudited) | Quarterly Results (Unaudited) Three Months Ended March 31, 2021 June 30, 2021 September 30, 2021 December 31, 2021 (in thousands, expect per share data) (unaudited) Revenues: FOTIVDA U.S. product revenue, net* $ 1,066 $ 6,735 $ 14,318 $ 16,755 Partnership licensing and royalty revenue 854 821 855 891 1,920 7,556 15,173 17,646 Operating expenses: Cost of products sold* 138 822 1,744 2,033 Research and development 5,797 6,878 7,502 6,121 Selling, general and administrative* 15,100 14,920 15,142 15,652 21,035 22,620 24,388 23,806 Loss from operations (19,115) (15,064) (9,215) (6,160) Other income (expense), net: Interest expense, net (611) (1,128) (1,153) (1,153) Change in fair value of PIPE Warrant liability (2,396) 2,595 — — Other income — — — 58 Other income (expense), net (3,007) 1,467 (1,153) (1,095) Net income (loss) $ (22,122) $ (13,597) $ (10,368) $ (7,255) Net loss per share - basic and diluted $ (0.81) $ (0.40) $ (0.30) $ (0.21) Weighted average number of common shares outstanding 27,429 34,362 34,374 34,384 *FOTIVDA is the Company's first commercial product and was approved by the FDA for marketing and sale in the United States on March 10, 2021 for the treatment of adult patients with relapsed or refractory advanced RCC following two or more prior systemic therapies. Three Months Ended March 31, 2020 June 30, 2020 September 30, 2020 December 31, 2020 (in thousands, expect per share data) (unaudited) Partnership licensing and royalty revenue $ 784 $ 749 $ 3,600 $ 886 Operating expenses: Research and development 7,826 4,419 5,860 4,574 Selling, general and administrative 3,672 3,737 5,800 9,008 11,498 8,156 11,660 13,582 Loss from operations (10,714) (7,407) (8,060) (12,696) Other income (expense), net: Interest expense, net (315) (349) (419) (522) Change in fair value of PIPE Warrant liability 2,648 450 86 1,714 Other income (expense), net 2,333 101 (333) 1,192 Net income (loss) $ (8,381) $ (7,306) $ (8,393) $ (11,504) Net loss per share - basic and diluted $ (0.52) $ (0.42) $ (0.33) $ (0.44) Weighted average number of common shares outstanding 16,081 17,364 25,808 26,252 |
Legal Proceedings
Legal Proceedings | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Legal Proceedings | Legal Proceedings As of the date of filing this Annual Report on Form 10-K, there are no material outstanding legal proceedings against the Company or its current officers or directors. |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Revenue Recognition | Revenue Recognition Under Accounting Standards Codification (“ASC”) 606, Revenue from Contracts with Customers , the Company recognizes revenue when its customers obtain control of promised goods or services, in an amount that reflects the consideration which the Company determines it expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligation(s) in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligation(s) in the contract; and (v) recognize revenue when (or as) the Company satisfies its performance obligation(s). As part of the accounting for these arrangements, the Company must make significant judgments, including identifying performance obligations in the contract, estimating the amount of variable consideration to include in the transaction price and allocating the transaction price to each performance obligation. Net Product Revenue On March 10, 2021, the FDA approved FOTIVDA in the United States for the treatment of adult patients with relapsed or refractory advanced RCC after two prior systemic therapies. FOTIVDA became commercially available on March 22, 2021. FOTIVDA is the Company’s first commercial product. The Company sells its products principally through a limited distribution network comprised of two specialty pharmacies, Biologics and Onco360, and the following specialty distributors: Amerisource Specialty Distribution, Oncology Supply, McKesson Plasma and Biologics, McKesson Specialty and Cardinal Specialty (collectively with the specialty pharmacies, the "Customers" and each a "Customer"). These Customers subsequently resell the Company’s products to health care providers and patients. In addition to distribution agreements with Customers, the Company enters into arrangements with health care providers and payors that provide for government-mandated and/or privately-negotiated rebates, chargebacks and discounts with respect to the purchase of the Company’s products. Revenues from product sales are recognized when the Customer obtains control of the Company’s product, which occurs at a point in time, typically upon delivery to the Customer. Product Sales Discounts and Allowances The Company records revenues from product sales at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established primarily from discounts, chargebacks, rebates, co-pay assistance, returns 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 sales of its products. These reserves are based on the amounts earned or to be claimed on the related sales and are classified as reductions of trade receivables (if the amount is deductible by the Customer from payments to the Company) or a current liability (if the amount is payable by the Company to a third party or Customer). Where appropriate, these estimates take into consideration a range of possible outcomes that are probability-weighted for relevant factors such as current contractual and statutory requirements, specific known market events and trends, industry data, forecasted Customer buying and payment patterns, and the Company’s historical experience that will develop over time as FOTIVDA is the Company’s first commercial product. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of its contracts. The amount of variable consideration that is included in the transaction price may be constrained, and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. 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 revenues and earnings in the period such variances become known. Chargebacks: Chargebacks are discounts that occur when contracted customers purchase directly from a specialty distributor. Contracted customers, which currently consist primarily of Public Health Service institutions, Federal government entities purchasing via the Federal Supply Schedule, Group Purchasing Organizations and health maintenance organizations, generally purchase the product at a discounted price. The specialty distributor, in turn, charges back to the Company the difference between the price initially paid by the specialty distributor and the discounted price paid to the specialty distributor by its contracted customer. The allowance for chargebacks is based on actual chargebacks received and an estimate of sales by the specialty distributor to its contracted customers. Discounts for Prompt Payment: The Customers receive a discount of 2% for prompt payment. The Company expects its Customers will earn 100% of their prompt payment discounts and, therefore, the Company deducts the full amount of these discounts from total product sales when revenues are recognized. Rebates: Allowances for rebates include mandated discounts under the Medicaid Drug Rebate Program, Medicare Part D Coverage Gap Discounts Program, other government programs and commercial contracts. Rebate amounts owed after the final dispensing of the product to a benefit plan participant are based upon contractual agreements or legal requirements with public sector benefit providers, such as Medicaid. In addition, in the United States during 2020, the Medicare Part D prescription drug benefit mandated participating manufacturers to fund 70% of the Medicare Part D insurance coverage gap for prescription drugs sold to eligible patients. The allowance for rebates is based on statutory or contractual discount rates and expected utilization. The Company’s estimates for the expected utilization of rebates are based on Customer and payer data received from the specialty pharmacies and distributors and historical utilization rates that will develop over time as FOTIVDA is the Company’s first commercial product. Rebates are generally invoiced by the payor and paid in arrears, such that the accrual balance consists of an estimate of the amount expected to be incurred for the current quarter’s shipments to the Customers, plus an accrual balance for known prior quarters’ unpaid rebates. If actual future rebates vary from estimates, the Company may need to adjust its accruals, which would affect net product revenues in the period of adjustment. Co-payment Assistance: Patients who have commercial insurance and meet certain eligibility requirements may receive co-payment assistance. The Company accrues a liability for co-payment assistance based on actual program participation and estimates of program redemption using Customer data provided by the third party that administers the copay program. Other Customer Credits: The Company pays fees to its Customers for account management, data management and other administrative services. To the extent the services received are distinct from the sale of products to its Customers, the Company classifies these payments in selling, general and administrative expenses in its Consolidated Statements of Income. Trade Receivables Trade receivables, net, includes amounts billed to Customers for product sales of FOTIVDA. The Company records trade receivables net of chargebacks, cash discounts for prompt payment and any allowances for credit losses. The Company considers its historical losses, if any, adjusted to account for current conditions, and reasonable and supportable forecasts of future economic conditions affecting its customers to estimate credit losses. The Customers are specialty pharmacies and specialty distributors, and accordingly, the Company considers the risk of potential credit losses to be low. Cost of Products Sold Cost of products sold is related to the Company's product revenues for FOTIVDA and consists primarily of tiered royalty payments the Company is required to pay to Kyowa Kirin Co. (“KKC”) on all net sales of tivozanib in the Company’s North American territory, which range from the low to mid-teens as a percentage of net sales. Refer to Note 4, “Collaborations and License Agreements” |
Collaboration Revenues | Collaboration Revenues The Company’s historical revenues have been generated primarily through collaborative research, development and commercialization agreements. The terms of these agreements generally contain multiple promised goods and services, which may include (i) licenses, or options to obtain licenses, to the Company’s technology, (ii) research and development activities to be performed on behalf of the collaborative partner and (iii) in certain cases, services in connection with the manufacturing of preclinical and clinical material. Payments to the Company under these arrangements typically include one or more of the following: non-refundable, upfront license fees; option exercise fees; funding of research and/or development efforts; milestone payments; and royalties on future product sales. Collaboration Arrangements Within the Scope of ASC 808, Collaborative Arrangements The Company analyzes its collaboration arrangements to assess whether such arrangements involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards dependent on the commercial success of such activities and are therefore within the scope of ASC Topic 808, Collaborative Arrangements (“ASC 808”). This assessment is performed throughout the life of the arrangement based on changes in the responsibilities of all parties in the arrangement. For collaboration arrangements that are deemed to be within the scope of ASC 808, the Company first determines which elements of the collaboration are deemed to be within the scope of ASC 808 and those that are more reflective of a vendor-customer relationship and therefore within the scope of ASC 606. The Company’s policy is generally to recognize amounts received from collaborators in connection with joint operating activities that are within the scope of ASC 808 as a reduction in research and development expense. Arrangements Within the Scope of ASC 606, Revenue from Contracts with Customers Once a contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within the contract and determines those that are performance obligations. Arrangements that include rights to additional goods or services that are exercisable at a customer’s discretion are generally considered options. The Company assesses if these options provide a material right to the customer and if so, they are considered performance obligations. The exercise of a material right is accounted for as a contract modification for accounting purposes. The Company assesses whether each promised good or service is distinct for the purpose of identifying the performance obligations in the contract. This assessment involves subjective determinations and requires management to make judgments about the individual promised goods or services and whether such are separable from the other aspects of the contractual relationship. Promised goods and services are considered distinct provided that: (i) the customer can benefit from the good or service either on its own or together with other resources that are readily available to the customer (that is, the good or service is capable of being distinct) and (ii) the entity’s promise to transfer the good or service to the customer is separately identifiable from other promises in the contract (that is, the promise to transfer the good or service is distinct within the context of the contract). In assessing whether a promised good or service is distinct, the Company considers factors such as the research, manufacturing and commercialization capabilities of the collaboration partner and the availability of the associated expertise in the general marketplace. The Company also considers the intended benefit of the contract in assessing whether a promised good or service is separately identifiable from other promises in the contract. If a promised good or service is not distinct, an entity is required to combine that good or service with other promised goods or services until it identifies a bundle of goods or services that is distinct. The transaction price is then determined and allocated to the identified performance obligations in proportion to their standalone selling prices (“SSP”) on a relative SSP basis. SSP are determined at contract inception and are not updated to reflect changes between contract inception and when the performance obligations are satisfied. Determining SSP for performance obligations requires significant judgment. In developing SSP for a performance obligation, the Company considers applicable market conditions and relevant entity-specific factors, including factors that were contemplated in negotiating the agreement with the customer and estimated costs. The Company validates SSP for performance obligations by evaluating whether changes in the key assumptions used to determine SSP will have a significant effect on the allocation of arrangement consideration between multiple performance obligations. If the consideration promised in a contract includes a variable amount, the Company estimates the amount of consideration to which it will be entitled in exchange for transferring the promised goods or services to a customer. The Company determines the amount of variable consideration by using the expected value method or the most likely amount method. The Company includes the unconstrained amount of estimated variable consideration in the transaction price. The amount included in the transaction price is constrained to the amount for which it is probable that a significant reversal of cumulative revenue recognized will not occur. At the end of each subsequent reporting period, the Company re-evaluates the estimated variable consideration included in the transaction price and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis in the period of adjustment. In determining the transaction price, the Company adjusts consideration for the effects of the time value of money if the timing of payments provides the Company with a significant benefit of financing. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the licensees and the transfer of the promised goods or services to the licensees will be one year or less. The Company assessed each of its revenue generating arrangements in order to determine whether a significant financing component exists and concluded that a significant financing component does not exist in any of its arrangements. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) each performance obligation is satisfied at a point in time or over time, and if over time based on the use of an output or input method. Licenses of Intellectual Property: The terms of the Company’s license agreements include the license of functional intellectual property, given the functionality of the intellectual property is not expected to change substantially as a result of the Company’s ongoing activities. If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from the portion of the transaction price allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises (that is, for licenses that are not distinct from other promised goods and services in an arrangement), 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. Research and Development Funding: Arrangements that include payment for research and development services are generally considered to have variable consideration. If and when the Company assesses the payment for these services is no longer subject to the constraint on variable consideration, the related revenue is included in the transaction price. Milestone payments: At the inception of each arrangement that includes non-refundable payments for contingent milestones, including preclinical research and development, clinical development and regulatory, 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. At the end of each reporting period, the Company re-evaluates the probability of the achievement of contingent milestones and the likelihood of a significant reversal of such milestone revenue, 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 collaboration and licensing revenue in the period of adjustment. This quarterly assessment may result in the recognition of revenue related to a contingent milestone payment before the milestone event has been achieved. Royalties: For arrangements that include sales-based royalties, including milestone payments based on the 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). |
Research and Development Expenses | Research and Development Expenses Research and development expenses are charged to expense as incurred. Research and development expenses consist of costs incurred in performing research and development activities, including (i) internal costs for salaries, bonuses, benefits, stock-based compensation, research-related overhead and allocated expenses for facilities and information technology, and (ii) external costs for clinical trials, drug manufacturing and distribution, preclinical studies, upfront license payments, milestones and sublicense fees related to in-licensed products and technology, consultants and other contracted services. |
Expired Warrants Issued in Connection with Private Placement | Expired Warrants Issued in Connection with Private Placement – Expiration Date of May 16, 2021 The PIPE Warrants contained a provision giving the warrant holder the option to receive cash, equal to the fair value of the remaining unexercised portion of the warrant, as cash settlement in the event that there had been a fundamental transaction (contractually defined to include various merger, acquisition or stock transfer activities). Due to this provision, ASC 480, Distinguishing Liabilities from Equity |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investments with original maturities of three months or less at the date of purchase and an investment in a United States government money market fund to be cash equivalents. Changes in the balance of cash and cash equivalents may be affected by changes in investment portfolio maturities, as well as actual cash disbursements to fund operations. |
Marketable Securities | Marketable Securities Marketable securities consist primarily of investments which have expected average maturity dates in excess of three months. The Company invests in high-grade corporate obligations, including commercial paper, and United States |
Concentrations of Credit Risk | Concentrations of Credit Risk Financial instruments that potentially subject the Company to credit risk primarily consist of cash and cash equivalents, marketable securities and accounts receivable. The Company maintains deposits in highly-rated, federally-insured financial institutions in excess of federally insured limits. The Company’s investment strategy is focused on capital preservation. The Company invests in instruments that meet the high credit quality standards outlined in the Company’s investment policy. This policy also limits the amount of credit exposure to any one issue or type of instrument. The Company’s trade receivables, net, includes amounts billed to Customers for product sales of FOTIVDA. The Customers are a limited group of specialty pharmacies and specialty distributors, and accordingly, the Company considers the risk of potential credit losses to be low. |
Basic and Diluted Net Loss per Common Share | Basic and Diluted Net Loss per Common Share Basic net income (loss) per share attributable to the Company’s common stockholders is based on the weighted-average number of common shares outstanding during the period. Diluted net income (loss) per share attributable to the Company’s common stockholders is based on the weighted-average number of common shares outstanding during the period plus additional weighted-average common equivalent shares outstanding during the period when the effect is dilutive. For the years ended December 31, 2021 and 2020, diluted net loss per share is the same as basic net loss per share as the inclusion of weighted-average shares of common stock issuable upon the exercise of outstanding stock options and warrants until the expirations of the Offering Warrants on April 8, 2021 and the PIPE Warrants on May 16, 2021 would be anti-dilutive. |
Stock-Based Compensation | Stock-Based Compensation Under the Company’s stock-based compensation programs, the Company periodically grants stock options and restricted stock to employees, directors and nonemployee consultants. The Company also issues shares under an employee |
Income Taxes | Income Taxes The Company provides for income taxes using the asset-liability method. Under this method, deferred tax assets and liabilities are recognized based on differences between financial reporting and tax bases of assets and liabilities, and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. The Company calculates its provision for income taxes on ordinary income based on its projected annual tax rate for the year. Uncertain tax positions are recognized if the position is more-likely-than-not to be sustained upon examination by a tax authority. Unrecognized tax benefits represent tax positions for which reserves have been established. The Company maintains a full valuation allowance on all deferred tax assets. |
Segment and Geographic Information | Segment and Geographic Information Operating segments are defined as components of an enterprise engaging in business activities for which discrete financial information is available and regularly reviewed by the chief operating decision maker in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one operating segment principally in the United States. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect certain reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the financial statements, the assessment of the Company’s ability to continue as a going concern and the reported amounts of revenues and expenses during the reporting periods. Significant items subject to such estimates and assumptions include revenue recognition, clinical trial costs and contract research accruals, measurement of trade receivables net, measurement of stock-based compensation and estimates of the Company’s capital requirements over the next twelve months from the date of issuance of the consolidated financial statements. The Company bases its estimates on historical experience and various other assumptions that management believes to be reasonable under the circumstances. Material changes in these estimates could occur in the future. Changes in estimates are recorded or reflected in the Company’s disclosures in the period in which they become known. Actual results could differ from those estimates if past experience or other assumptions do not turn out to be substantially accurate. Accrued Clinical Trial Costs and Contract Research Liabilities During each of the years ended December 31, 2021, 2020 and 2019, the Company had arrangements with multiple contract research organizations (“CROs”) whereby these organizations commit to performing services for the Company over multiple reporting periods. The Company recognizes the expenses associated with these arrangements based on its expectation of the timing of the performance of components under these arrangements by these organizations. Generally, these components consist of the costs of setting up the trial, monitoring the trial, closing the trial and preparing the resulting data. Costs related to patient enrollment in clinical trials are accrued as patients are enrolled in the trial. In addition to fees earned by the CROs to manage the Company’s clinical trials, the CROs are also responsible for managing payments to the clinical trial sites on the Company’s behalf. There can be significant lag time in clinical trial sites invoicing the CROs. The date on which services are performed, the level of services performed and the cost of such services are often determined based on subjective judgments. The Company makes these judgments based upon the facts and circumstances known to it, such as the terms of the contract and its knowledge of activity that has been incurred, including the number of active clinical sites, the number of patients enrolled, the activities to be performed for each patient, including patient treatment and any imaging, if applicable, and the duration for which the patients will be enrolled in the trial. In the event that the Company does not identify some costs which have begun to be incurred, or the Company under or overestimates the level of services performed or the costs of such services in a given period, its reported expenses for such period would be understated or overstated. The Company currently reflects the effects of any changes in estimates based on changes in facts and circumstances directly in its operations in the period such change becomes known. With respect to financial reporting periods presented in this Annual Report on Form 10-K, the timing of the Company’s actual costs incurred have not differed materially from its estimated timing of such costs. |
Recently Adopted Accounting Pronouncements | Recently Adopted Accounting Pronouncements In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (“ASU 2019-12”), which is intended to simplify the accounting for income taxes. ASU 2019-12 removes certain exceptions to the general principles in Topic 740 and also clarifies and amends existing guidance to improve consistent application. The Company adopted ASU 2019-02 effective January 1, 2021. The adoption of this standard did not have a material impact on the Company’s consolidated financial statements. |
Significant Accounting Polici_3
Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Summary of Net Product Revenues Earned | The following table summarizes net product revenues for FOTIVDA in the United States earned in the years ended December 31, 2021, 2020 and 2019, respectively (in thousands): Years Ended 2021 2020 2019 Product revenues: Gross product revenues $ 45,668 $ — $ — Discounts and allowances (6,794) — — Net product revenues $ 38,874 $ — $ — |
Summary of Percentage of Total Product Revenues | The following table summarizes the percentage of total product revenues for FOTIVDA in the United States by any Customer who individually accounted for 10% or more of total product revenues earned in the years ended December 31, 2021, 2020 and 2019, respectively: Years Ended 2021 2020 2019 OncoMed Specialty, LLC (Onco360) 22 % — — Affiliates of McKesson Corporation 42 % — — Affiliates of AmerisourceBergen Corporation 27 % — — |
Schedule of Provision on Discounts and Allowances by Category | The activities and ending allowance balances for each significant category of discounts and allowances for FOTIVDA (which constitute variable consideration) for the year ended December 31, 2021 were as follows (in thousands): Chargebacks, Discounts for Rebates, Customer Fees / Credits Totals Balance at December 31, 2020 $ — $ — $ — Provision related to sales made in: Current period 4,196 2,598 6,794 Prior periods — — — Payments and customer credits issued (3,003) (1,428) (4,431) Balance at December 31, 2021 $ 1,193 $ 1,170 $ 2,363 |
Schedule of Collaborative Revenues Under Collaboration Agreement | The following table summarizes the total collaboration revenues earned in the years ended December 31, 2021, 2020 and 2019, respectively, by partner (in thousands). Refer to Note 4, “Collaborations and License Agreements” regarding specific details. Years Ended 2021 2020 2019 EUSA $ 3,421 $ 3,219 $ 3,795 KKC — 2,800 25,000 Total $ 3,421 $ 6,019 $ 28,795 |
Summary of Fair Value of Company's Warrant Liability | The following table rolls forward the fair value of the Company’s PIPE Warrant liability, the fair value of which is determined by using Level 3 inputs for the years ended December 31, 2021, 2020 and 2019 (in thousands): Fair value at December 31, 2018 $ 16,674 Decrease in fair value (11,577) Fair value at December 31, 2019 $ 5,097 Decrease in fair value (4,898) Fair value at December 31, 2020 $ 199 Decrease in fair value (199) Fair value at December 31, 2021 $ — |
Key Assumptions Used to Value the Warrants | The key assumptions used to value the PIPE Warrants were as follows: Issuance December 31, December 31, December 31, Expected price volatility 76.25% 82.64 % 133.07 % 56.79 % Expected term (in years) 5.00 2.5 1.5 0.50 Risk-free interest rates 1.22% 2.47 % 1.59 % 0.09 % Stock price $ 8.90 $ 16.00 $ 6.20 $ 5.77 Dividend yield — — — — |
Summary of Cash, Cash Equivalents and Marketable Securities | Below is a summary of cash, cash equivalents and marketable securities at December 31, 2021 and December 31, 2020 (in thousands): Amortized Cost Unrealized Unrealized Fair December 31, 2021 Cash and cash equivalents: Cash and money market funds $ 70,542 $ — $ — $ 70,542 Total cash and cash equivalents 70,542 — — 70,542 Marketable securities: Corporate debt securities due within 1 year $ 16,787 $ — $ (3) $ 16,784 Total marketable securities 16,787 — (3) 16,784 Total cash, cash equivalents and marketable securities $ 87,329 $ — $ (3) $ 87,326 December 31, 2020 Cash and cash equivalents: Cash and money market funds $ 61,761 $ — $ — $ 61,761 Total cash, cash equivalents and marketable securities $ 61,761 $ — $ — $ 61,761 |
Summary of Assets and Liabilities Measured at Fair Value on Recurring Basis | The following table summarizes the financial assets and liabilities measured at fair value on a recurring basis at December 31, 2021 and December 31, 2020 (in thousands): Fair Value Measurements as of December 31, 2021 Level 1 Level 2 Level 3 Total Financial assets carried at fair value: Cash and money market funds $ 70,542 $ — $ — $ 70,542 Total cash and cash equivalents $ 70,542 $ — $ — $ 70,542 Marketable securities: Corporate debt securities due within 1 year $ — $ 16,784 $ — $ 16,784 Total marketable securities $ — $ 16,784 $ — $ 16,784 Total cash, cash equivalents and marketable securities $ 70,542 $ 16,784 $ — $ 87,326 Fair Value Measurements as of December 31, 2020 Level 1 Level 2 Level 3 Total Financial assets carried at fair value: Cash and money market funds $ 61,761 $ — $ — $ 61,761 Total cash, cash equivalents and marketable securities $ 61,761 $ — $ — $ 61,761 Financial liabilities carried at fair value: Total PIPE Warrant liability $ — $ — $ 199 $ 199 |
Schedule of Loss Per Share | The following table summarizes the computation of basic and diluted net loss per share for the years ended December 31, 2021, 2020 and 2019, respectively (in thousands except per share amounts): Years Ended December 31, 2021 2020 2019 Basic and diluted net income (loss) attributable to common stockholders $ (53,342) $ (35,584) $ 9,388 Weighted-average shares of common stock outstanding 32,661 21,402 15,331 Dilutive securities: Incremental common shares issuable upon the exercise of dilutive stock options — — 45 Weighted-average number of common shares outstanding and dilutive share equivalents outstanding 32,661 21,402 15,376 Basic net income (loss) per share $ (1.63) $ (1.66) $ 0.61 Diluted net income (loss) per share $ (1.63) $ (1.66) $ 0.61 |
Summary of Outstanding Securities not Included in Computation of Diluted Net Loss Per Common Share | The following table summarizes outstanding securities not included in the computation of diluted net loss per common share as the effect would have been anti-dilutive for the years ended December 31, 2021, 2020 and 2019, respectively (in thousands): Outstanding at December 31, 2021 2020 2019 Stock options outstanding 3,156 1,797 1,168 Offering Warrants outstanding (warrants expired April 8, 2021) — 2,500 2,500 PIPE Warrants outstanding (warrants expired May 16, 2021) — 1,684 1,684 Total 3,156 5,981 5,352 |
Stock-Based Compensation Expense | During the years ended December 31, 2021, 2020 and 2019, the Company recorded the following stock-based compensation expense (in thousands): Years Ended 2021 2020 2019 Research and development $ 1,218 $ 499 $ 662 Selling, general and administrative 3,924 1,856 1,696 Total $ 5,142 $ 2,355 $ 2,358 |
Collaborations and License Ag_2
Collaborations and License Agreements (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Summary of Revenues Earned in Connection with EUSA Agreement under ASC 606 | The following table summarizes the revenues earned in connection with the EUSA Agreement under ASC 606 for the years ended December 31, 2021, 2020 and 2019 (in thousands): Years Ended Revenue Type Date Achieved 2021 2020 2019 Collaboration and Licensing Revenue: Amounts in contract liabilities at the beginning of the period: Upfront payment December 2015 $ 395 $ 395 $ 395 R&D payment - EMA approval in RCC August 2017 631 631 631 Milestone - UK reimbursement approval February 2018 316 316 316 Milestone - German reimbursement approval November 2018 316 316 316 Milestone - Spanish reimbursement approval February 2019 316 316 1,276 $ 1,974 $ 1,974 $ 2,934 Partnership Royalties 1,447 1,245 861 Total $ 3,421 $ 3,219 $ 3,795 |
Summary of Changes in Accounts Receivable and Contract Liabilities (Deferred Revenue) | The following table summarizes changes in the Company’s accounts receivable and contract liabilities (deferred revenue) in connection with the EUSA Agreement for the year ended December 31, 2021 (in thousands): Contract Assets Beginning Balance January 1, 2021 Additions Deductions Ending Balance December 31, 2021 Partnership receivables $ 392 $ 1,447 $ (1,079) $ 760 Deferred Revenue Contract Liabilities Transaction Price Date Achieved Date Paid Beginning Balance January 1, 2021 Additions Deductions Ending Balance December 31, 2021 Amounts in contract liabilities at the beginning of the period: Upfront payment $ 2,500 December 2015 December 2015 $ 512 $ — $ 395 $ 117 R&D payment - EMA approval in RCC 4,000 August 2017 September 2017 817 — 631 186 Milestone - UK reimbursement approval 2,000 February 2018 March 2018 408 — 316 92 Milestone - German reimbursement approval 2,000 November 2018 December 2018 407 — 316 91 Milestone - Spanish reimbursement approval 2,000 February 2019 May 2019 408 — 316 92 Total $ 12,500 $ 2,552 $ — $ 1,974 $ 578 |
Other Accrued Liabilities (Tabl
Other Accrued Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Accrued Liabilities, Current [Abstract] | |
Other Accrued Liabilities | Other accrued expenses consisted of the following (in thousands): December 31, December 31, FOTIVDA U.S. Product Royalties 2,011 — FOTIVDA Federal Rebates, Customer Credits and Co-Pay Assistance 1,170 — Professional Fees 1,107 1,061 Other 1,133 320 Total 5,421 1,381 |
Hercules Loan Facility (Tables)
Hercules Loan Facility (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
Future Minimum Payments Under Loans Payable | Future minimum payments under the loans payable outstanding as of December 31, 2021 are as follows (in thousands): Year Ending December 31: Amount 2022 $ 3,885 2023 22,528 2024 24,406 $ 50,819 Less amount representing interest (8,039) Less unamortized discount (2,040) Less deferred charges (2,780) Less loans payable current, net of discount — Loans payable, net of current portion and discount $ 37,960 |
Stock-based Compensation (Table
Stock-based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Stock Option Activity | The following table summarizes stock option activity during the year ended December 31, 2021: Options Weighted- Average Exercise Price Weighted- Average Remaining Contractual Term Aggregate Intrinsic Value Outstanding at January 1, 2021 1,816,690 $ 11.04 7.53 $ 170,000 Granted 1,751,218 8.37 Exercised (2,479) 5.97 Forfeited (409,050) 11.87 Outstanding at December 31, 2021 3,156,379 $ 9.45 7.55 $ 5,720 Exercisable at December 31, 2021 1,357,101 $ 11.72 5.82 $ 1,907 |
Assumptions used in Black-Scholes Pricing Model for New Grants | The following tables summarize the assumptions used in the Black-Scholes option-pricing model in the years ended December 31, 2021, 2020 and 2019: Years Ended 2021 2020 2019 Volatility factor 56.17% - 102.66% 94.37% - 102.48% 88.27% - 98.81% Expected term (in years) 0.25 - 6.25 5.50 - 6.25 5.50 - 6.25 Risk-free interest rates 0.06% - 1.33% 0.31% - 1.67% 1.43% - 2.55% Dividend yield — — — |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Schedule of Effective Income Tax Rate Reconciliation | A reconciliation of the expected income tax benefit computed using the federal statutory income tax rate to the Company’s effective income tax rate is as follows for the years ended December 31, 2021, 2020 and 2019: Years Ended December 31, 2021 2020 2019 Income tax computed at federal statutory tax rate 21.0 % 21.0 % 21.0 % State taxes, net of federal benefit 3.6 % 6.7 % 1.3 % Research and development credits 1.6 % 1.5 % (4.2) % PIPE Warrants 0.1 % 2.9 % (25.9) % Other permanent differences (0.9) % (0.5) % 1.8 % Other (0.5) % (1.1) % 5.7 % Change in valuation allowance (24.9) % (30.5) % 0.3 % Total — % — % — % |
Schedule of Deferred Tax Assets and Liabilities | The Company’s net deferred tax assets as of December 31, 2021 and 2020 are as follows (in thousands): December 31, 2021 2020 (in thousands) Deferred tax assets: NOL carryforwards $ 160,833 $ 148,689 Research and development credits 16,088 15,271 Deferred revenue and R&D reimbursements 149 742 Other temporary differences 5,930 5,001 Total deferred tax assets: 183,000 169,703 Valuation allowance (183,000) (169,703) Total $ — $ — |
Schedule of Unrecognized Tax Benefits Roll Forward | The following is a reconciliation of the Company’s gross uncertain tax positions at December 31, 2021, 2020 and 2019: Years Ended December 31, 2021 2020 2019 (in thousands) Amount established upon adoption $ 1,078 $ 1,200 $ 1,200 Additions for current year tax provisions — — — Additions for prior year tax provisions — — — Reductions of prior year tax provisions (113) (122) — Balance as of end of year $ 965 $ 1,078 $ 1,200 |
Quarterly Results (Unaudited) (
Quarterly Results (Unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Quarterly Financial Information Disclosure [Abstract] | |
Quarterly Financial Information | Three Months Ended March 31, 2021 June 30, 2021 September 30, 2021 December 31, 2021 (in thousands, expect per share data) (unaudited) Revenues: FOTIVDA U.S. product revenue, net* $ 1,066 $ 6,735 $ 14,318 $ 16,755 Partnership licensing and royalty revenue 854 821 855 891 1,920 7,556 15,173 17,646 Operating expenses: Cost of products sold* 138 822 1,744 2,033 Research and development 5,797 6,878 7,502 6,121 Selling, general and administrative* 15,100 14,920 15,142 15,652 21,035 22,620 24,388 23,806 Loss from operations (19,115) (15,064) (9,215) (6,160) Other income (expense), net: Interest expense, net (611) (1,128) (1,153) (1,153) Change in fair value of PIPE Warrant liability (2,396) 2,595 — — Other income — — — 58 Other income (expense), net (3,007) 1,467 (1,153) (1,095) Net income (loss) $ (22,122) $ (13,597) $ (10,368) $ (7,255) Net loss per share - basic and diluted $ (0.81) $ (0.40) $ (0.30) $ (0.21) Weighted average number of common shares outstanding 27,429 34,362 34,374 34,384 *FOTIVDA is the Company's first commercial product and was approved by the FDA for marketing and sale in the United States on March 10, 2021 for the treatment of adult patients with relapsed or refractory advanced RCC following two or more prior systemic therapies. Three Months Ended March 31, 2020 June 30, 2020 September 30, 2020 December 31, 2020 (in thousands, expect per share data) (unaudited) Partnership licensing and royalty revenue $ 784 $ 749 $ 3,600 $ 886 Operating expenses: Research and development 7,826 4,419 5,860 4,574 Selling, general and administrative 3,672 3,737 5,800 9,008 11,498 8,156 11,660 13,582 Loss from operations (10,714) (7,407) (8,060) (12,696) Other income (expense), net: Interest expense, net (315) (349) (419) (522) Change in fair value of PIPE Warrant liability 2,648 450 86 1,714 Other income (expense), net 2,333 101 (333) 1,192 Net income (loss) $ (8,381) $ (7,306) $ (8,393) $ (11,504) Net loss per share - basic and diluted $ (0.52) $ (0.42) $ (0.33) $ (0.44) Weighted average number of common shares outstanding 16,081 17,364 25,808 26,252 |
Organization (Details)
Organization (Details) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2021USD ($)subsidiaryemployeecandidate | Mar. 10, 2022USD ($) | Mar. 10, 2021subjecttrial | Dec. 31, 2020USD ($) | |
Significant Accounting Policies [Line Items] | ||||
Number of additional trials | trial | 3 | |||
Number of clinical trial subjects | subject | 1,000 | |||
Number of field-based employees | employee | 65 | |||
Number of sales professionals | employee | 50 | |||
Number of product candidates | candidate | 4 | |||
Number of subsidiaries | subsidiary | 3 | |||
Accumulated deficit | $ (674,547) | $ (621,205) | ||
Cash, cash equivalents and marketable securities | $ 87,326 | $ 61,761 | ||
Subsequent Event | ||||
Significant Accounting Policies [Line Items] | ||||
Cash, cash equivalents and marketable securities | $ 87,300 |
Significant Accounting Polici_4
Significant Accounting Policies - Additional Information (Details) | 12 Months Ended | |||||||||||
Dec. 31, 2021USD ($)segmentshares | Dec. 31, 2020USD ($)shares | Dec. 31, 2019USD ($) | May 16, 2021$ / sharesshares | Apr. 08, 2021$ / shares | Mar. 31, 2021shares | Mar. 26, 2021shares | Jun. 19, 2020shares | Feb. 19, 2020shares | Feb. 18, 2020shares | Apr. 30, 2019$ / sharesshares | May 31, 2016shares | |
Significant Accounting Policies [Line Items] | ||||||||||||
Percentage discount for prompt payment | 2.00% | |||||||||||
Expected percentage of discounts earned | 100.00% | |||||||||||
Capitalized manufacturing costs | $ 1,700,000 | |||||||||||
Common stock, shares issued (in shares) | shares | 34,474,710 | 26,883,000 | 247,391 | 6,900,000 | 16,100,000 | 160,800,000 | ||||||
Non-cash change in fair value of PIPE Warrant liability | $ (199,000) | $ (4,898,000) | $ (11,577,000) | |||||||||
Restricted cash balances | 0 | |||||||||||
Warrants exercise price (in dollars per share) | $ / shares | $ 12.50 | |||||||||||
Level 3 | Fair Value Measurements Recurring | ||||||||||||
Significant Accounting Policies [Line Items] | ||||||||||||
Loans payable, fair value | $ 38,000,000 | |||||||||||
Stock Options | ||||||||||||
Significant Accounting Policies [Line Items] | ||||||||||||
Dividend yield | 0.00% | 0.00% | 0.00% | |||||||||
United States | ||||||||||||
Significant Accounting Policies [Line Items] | ||||||||||||
Number of operating segments | segment | 1 | |||||||||||
Non-US | ||||||||||||
Significant Accounting Policies [Line Items] | ||||||||||||
Net assets located outside of the United States | $ 0 | |||||||||||
Private Placement | ||||||||||||
Significant Accounting Policies [Line Items] | ||||||||||||
Common stock, shares issued (in shares) | shares | 54,402 | 1,764,242,000 | ||||||||||
Warrants exercise price (in dollars per share) | $ / shares | $ 10 | |||||||||||
Underwritten Public Offering | ||||||||||||
Significant Accounting Policies [Line Items] | ||||||||||||
Common stock, shares issued (in shares) | shares | 9,725,000 | 2,173,913 | ||||||||||
PIPE Warrants | ||||||||||||
Significant Accounting Policies [Line Items] | ||||||||||||
Warrants (in shares) | shares | 1,683,933 | |||||||||||
Warrants term | 5 years | |||||||||||
Warrant liability | 9,300,000 | |||||||||||
Non-cash change in fair value of PIPE Warrant liability | $ 200,000 | $ 3,100,000 | ||||||||||
PIPE Warrants | Private Placement | ||||||||||||
Significant Accounting Policies [Line Items] | ||||||||||||
Common stock, shares issued (in shares) | shares | 1,764,242 | |||||||||||
Offering Warrants | Underwritten Public Offering | ||||||||||||
Significant Accounting Policies [Line Items] | ||||||||||||
Warrants exercise price (in dollars per share) | $ / shares | $ 12.50 |
Significant Accounting Polici_5
Significant Accounting Policies - Summary of Net Product Revenues Earned (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||
Dec. 31, 2021 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Disaggregation Of Revenue [Line Items] | |||||||
Net product revenues | $ 17,646 | $ 15,173 | $ 7,556 | $ 1,920 | $ 42,295 | $ 6,019 | $ 28,795 |
Gross product revenues | |||||||
Disaggregation Of Revenue [Line Items] | |||||||
Net product revenues | 45,668 | 0 | 0 | ||||
Discounts and allowances | |||||||
Disaggregation Of Revenue [Line Items] | |||||||
Net product revenues | (6,794) | 0 | 0 | ||||
Product | |||||||
Disaggregation Of Revenue [Line Items] | |||||||
Net product revenues | $ 16,755 | $ 14,318 | $ 6,735 | $ 1,066 | $ 38,874 | $ 0 | $ 0 |
Significant Accounting Polici_6
Significant Accounting Policies - Summary of Percentage of Total Product Revenues (Details) - Revenue from Contract with Customer Benchmark - Customer Concentration Risk | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
OncoMed Specialty, LLC (Onco360) | |||
Disaggregation Of Revenue [Line Items] | |||
Percentage of product revenues | 22.00% | 0.00% | 0.00% |
Affiliates of McKesson Corporation | |||
Disaggregation Of Revenue [Line Items] | |||
Percentage of product revenues | 42.00% | 0.00% | 0.00% |
Affiliates of AmerisourceBergen Corporation | |||
Disaggregation Of Revenue [Line Items] | |||
Percentage of product revenues | 27.00% | 0.00% | 0.00% |
Significant Accounting Polici_7
Significant Accounting Policies - Schedule of Provision on Discounts and Allowances by Category (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2021USD ($) | |
Contract With Customer, Provision Related To Sales [Roll Forward] | |
Beginning balance | $ 0 |
Current period | 6,794 |
Prior periods | 0 |
Payments and customer credits issued | (4,431) |
Ending balance | 2,363 |
Chargebacks, Discounts for Prompt Pay and Other Allowances | |
Contract With Customer, Provision Related To Sales [Roll Forward] | |
Beginning balance | 0 |
Current period | 4,196 |
Prior periods | 0 |
Payments and customer credits issued | (3,003) |
Ending balance | 1,193 |
Rebates, Customer Fees / Credits and Co-Pay Assistance | |
Contract With Customer, Provision Related To Sales [Roll Forward] | |
Beginning balance | 0 |
Current period | 2,598 |
Prior periods | 0 |
Payments and customer credits issued | (1,428) |
Ending balance | $ 1,170 |
Significant Accounting Polici_8
Significant Accounting Policies - Schedule of Collaborative Revenues Under Collaboration Agreement (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||
Dec. 31, 2021 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Disaggregation Of Revenue [Line Items] | |||||||
Revenues | $ 17,646 | $ 15,173 | $ 7,556 | $ 1,920 | $ 42,295 | $ 6,019 | $ 28,795 |
Collaborative Arrangements | |||||||
Disaggregation Of Revenue [Line Items] | |||||||
Revenues | 3,421 | 6,019 | 28,795 | ||||
EUSA | |||||||
Disaggregation Of Revenue [Line Items] | |||||||
Revenues | 3,421 | 3,219 | 3,795 | ||||
EUSA | Collaborative Arrangements | |||||||
Disaggregation Of Revenue [Line Items] | |||||||
Revenues | 3,421 | 3,219 | 3,795 | ||||
KKC | Collaborative Arrangements | |||||||
Disaggregation Of Revenue [Line Items] | |||||||
Revenues | $ 0 | $ 2,800 | $ 25,000 |
Significant Accounting Polici_9
Significant Accounting Policies - Summary of Fair Value of Company's Warrant Liability (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |||
Fair value, beginning of period | $ 199 | $ 5,097 | $ 16,674 |
Decrease in fair value | (199) | (4,898) | (11,577) |
Fair value, end of period | $ 0 | $ 199 | $ 5,097 |
Significant Accounting Polic_10
Significant Accounting Policies - Key Assumptions Used to Value the Warrants (Details) - PIPE Warrants | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | May 31, 2016 |
Expected price volatility | ||||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | ||||
Measurement input | 0.5679 | 1.3307 | 0.8264 | 76.25 |
Expected term (in years) | ||||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | ||||
Measurement input | 0.50 | 1.5 | 2.5 | 5 |
Risk-free interest rates | ||||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | ||||
Measurement input | 0.0009 | 0.0159 | 0.0247 | 1.22 |
Stock price | ||||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | ||||
Measurement input | 5.77 | 6.20 | 16 | 8.90 |
Dividend yield | ||||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | ||||
Measurement input | 0 | 0 | 0 | 0 |
Significant Accounting Polic_11
Significant Accounting Policies - Summary of Cash, Cash Equivalents and Marketable Securities (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Cash and cash equivalents: | ||
Cash and money market funds | $ 70,542 | $ 61,761 |
Marketable securities: | ||
Amortized Cost | 16,787 | |
Unrealized Gains | 0 | 0 |
Unrealized Losses | (3) | 0 |
Fair Value | 16,784 | 0 |
Amortized Cost | 87,329 | 61,761 |
Total cash, cash equivalents and marketable securities | 87,326 | $ 61,761 |
Corporate Debt Securities | ||
Marketable securities: | ||
Amortized Cost | 16,787 | |
Unrealized Gains | 0 | |
Unrealized Losses | (3) | |
Fair Value | $ 16,784 |
Significant Accounting Polic_12
Significant Accounting Policies - Summary of Assets and Liabilities Measured at Fair Value on Recurring Basis (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Financial assets carried at fair value: | ||
Total cash and cash equivalents | $ 70,542 | $ 61,761 |
Marketable securities: | ||
Marketable securities | 16,784 | 0 |
Total cash, cash equivalents and marketable securities | 87,326 | 61,761 |
Fair Value Measurements Recurring | ||
Marketable securities: | ||
Marketable securities | 16,784 | |
Total cash, cash equivalents and marketable securities | 87,326 | 61,761 |
Financial liabilities carried at fair value: | ||
Total PIPE Warrant liability | 199 | |
Fair Value Measurements Recurring | Corporate Debt Securities | ||
Marketable securities: | ||
Marketable securities | 16,784 | |
Fair Value Measurements Recurring | Level 1 | ||
Marketable securities: | ||
Marketable securities | 0 | |
Total cash, cash equivalents and marketable securities | 70,542 | 61,761 |
Financial liabilities carried at fair value: | ||
Total PIPE Warrant liability | 0 | |
Fair Value Measurements Recurring | Level 1 | Corporate Debt Securities | ||
Marketable securities: | ||
Marketable securities | 0 | |
Fair Value Measurements Recurring | Level 2 | ||
Marketable securities: | ||
Marketable securities | 16,784 | |
Total cash, cash equivalents and marketable securities | 16,784 | 0 |
Financial liabilities carried at fair value: | ||
Total PIPE Warrant liability | 0 | |
Fair Value Measurements Recurring | Level 2 | Corporate Debt Securities | ||
Marketable securities: | ||
Marketable securities | 16,784 | |
Fair Value Measurements Recurring | Level 3 | ||
Marketable securities: | ||
Marketable securities | 0 | |
Total cash, cash equivalents and marketable securities | 0 | 0 |
Financial liabilities carried at fair value: | ||
Total PIPE Warrant liability | 199 | |
Fair Value Measurements Recurring | Level 3 | Corporate Debt Securities | ||
Marketable securities: | ||
Marketable securities | 0 | |
Fair Value Measurements Recurring | Cash and money market funds | ||
Financial assets carried at fair value: | ||
Total cash and cash equivalents | 70,542 | 61,761 |
Fair Value Measurements Recurring | Cash and money market funds | Level 1 | ||
Financial assets carried at fair value: | ||
Total cash and cash equivalents | 70,542 | 61,761 |
Fair Value Measurements Recurring | Cash and money market funds | Level 2 | ||
Financial assets carried at fair value: | ||
Total cash and cash equivalents | 0 | 0 |
Fair Value Measurements Recurring | Cash and money market funds | Level 3 | ||
Financial assets carried at fair value: | ||
Total cash and cash equivalents | $ 0 | $ 0 |
Significant Accounting Polic_13
Significant Accounting Policies - Summary of Computation of Basic and Diluted Net Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2021 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Dec. 31, 2020 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Accounting Policies [Abstract] | |||||||||||
Basic net income (loss) attributable to common stockholders | $ (53,342) | $ (35,584) | $ 9,388 | ||||||||
Diluted net income (loss) attributable to common stockholders | $ (53,342) | $ (35,584) | $ 9,388 | ||||||||
Weighted average number of common shares outstanding (in shares) | 34,384,000 | 34,374,000 | 34,362,000 | 27,429,000 | 26,252,000 | 25,808,000 | 17,364,000 | 16,081,000 | 32,661,000 | 21,402,000 | 15,331,000 |
Dilutive securities: | |||||||||||
Incremental common shares issuable upon the exercise of dilutive stock options (in shares) | 0 | 0 | 45,000 | ||||||||
Weighted-average number of common shares outstanding and dilutive share equivalents outstanding (in shares) | 34,384,000 | 34,374,000 | 34,362,000 | 27,429,000 | 26,252,000 | 25,808,000 | 17,364,000 | 16,081,000 | 32,661,000 | 21,402,000 | 15,376,000 |
Basic net income (loss) per share (in dollars per share) | $ (0.21) | $ (0.30) | $ (0.40) | $ (0.81) | $ (0.44) | $ (0.33) | $ (0.42) | $ (0.52) | $ (1.63) | $ (1.66) | $ 0.61 |
Diluted net income (loss) per share (in dollars per share) | $ (0.21) | $ (0.30) | $ (0.40) | $ (0.81) | $ (0.44) | $ (0.33) | $ (0.42) | $ (0.52) | $ (1.63) | $ (1.66) | $ 0.61 |
Significant Accounting Polic_14
Significant Accounting Policies - Summary of Outstanding Securities not Included in Computation of Diluted Net Loss Per Common Share (Details) - 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] | |||
Antidilutive securities excluded from computation of earnings per share amount, outstanding (in shares) | 3,156 | 5,981 | 5,352 |
Stock Options | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from computation of earnings per share amount, outstanding (in shares) | 3,156 | 1,797 | 1,168 |
Offering Warrants | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from computation of earnings per share amount, outstanding (in shares) | 0 | 2,500 | 2,500 |
PIPE Warrants | PIPE Warrants | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from computation of earnings per share amount, outstanding (in shares) | 0 | 1,684 | 1,684 |
Significant Accounting Polic_15
Significant Accounting Policies - Stock Based Compensation Expense for Equity-Classified Awards (Details) - 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] | |||
Total | $ 5,142 | $ 2,355 | $ 2,358 |
Research and development | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Total | 1,218 | 499 | 662 |
Selling, general and administrative | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Total | $ 3,924 | $ 1,856 | $ 1,696 |
Collaborations and License Ag_3
Collaborations and License Agreements - Additional Information (Details) | Aug. 01, 2019USD ($) | Feb. 28, 2022USD ($) | Aug. 31, 2020USD ($) | Sep. 30, 2019USD ($) | May 31, 2019USD ($) | Feb. 28, 2019USD ($) | Dec. 31, 2018USD ($) | Nov. 30, 2018USD ($) | Mar. 31, 2018USD ($) | Feb. 28, 2018USD ($) | Oct. 31, 2017USD ($) | Sep. 30, 2017USD ($) | Dec. 31, 2016 | Aug. 31, 2015USD ($) | Mar. 31, 2014USD ($) | Dec. 31, 2012USD ($) | Mar. 31, 2010USD ($) | Dec. 31, 2006USD ($) | Dec. 31, 2021USD ($) | Sep. 30, 2021USD ($) | Jun. 30, 2021USD ($) | Mar. 31, 2021USD ($) | Dec. 31, 2020USD ($) | Sep. 30, 2020USD ($) | Jun. 30, 2020USD ($) | Mar. 31, 2020USD ($) | Sep. 30, 2019USD ($) | Dec. 31, 2021USD ($)indication | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | Dec. 31, 2015USD ($) | Apr. 30, 2014USD ($) |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||||||||
Trade receivables, net | $ 9,811,000 | $ 0 | $ 9,811,000 | $ 0 | ||||||||||||||||||||||||||||
Milestone payment to be received | 2,000,000 | 2,000,000 | ||||||||||||||||||||||||||||||
Revenues | 17,646,000 | $ 15,173,000 | $ 7,556,000 | $ 1,920,000 | 42,295,000 | 6,019,000 | $ 28,795,000 | |||||||||||||||||||||||||
EUSA | ||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||||||||
Research and development reimbursement received | $ 2,000,000 | $ 4,000,000 | $ 2,500,000 | |||||||||||||||||||||||||||||
Percentage of EUSA cost-sharing for TIVO-3 trial | 50.00% | |||||||||||||||||||||||||||||||
Research and development reimbursement milestone | 20,000,000 | |||||||||||||||||||||||||||||||
Milestone payment to be received | $ 2,000,000 | 2,000,000 | ||||||||||||||||||||||||||||||
Collaborations and license agreements, expected milestone receivable | $ 2,000,000 | $ 2,000,000 | $ 2,000,000 | $ 2,000,000 | $ 2,000,000 | $ 2,000,000 | ||||||||||||||||||||||||||
Payments received in connection per indication | $ 2,000,000 | |||||||||||||||||||||||||||||||
Eligible number of indications | indication | 3 | |||||||||||||||||||||||||||||||
Payments received in connection with additional indications | $ 5,000,000 | |||||||||||||||||||||||||||||||
Potential payments received in connection with additional indications | $ 335,000,000 | |||||||||||||||||||||||||||||||
Sublicense fee to earned milestone payments and royalties | 30.00% | 30.00% | ||||||||||||||||||||||||||||||
Collaborations and license agreements, potential future payment as percentage of certain amounts the Company receives under sublicense agreements | 30.00% | 30.00% | ||||||||||||||||||||||||||||||
Milestone payment | $ 8,700,000 | $ 8,700,000 | ||||||||||||||||||||||||||||||
Milestone payment subject to sublicense fees | 20,000,000 | 20,000,000 | ||||||||||||||||||||||||||||||
Allocation of upfront payment | $ 600,000 | $ 600,000 | $ 600,000 | |||||||||||||||||||||||||||||
Revenues | 3,421,000 | 3,219,000 | 3,795,000 | |||||||||||||||||||||||||||||
Deferred revenue recognized as collaboration and licensing revenue | 578,000 | 2,552,000 | 578,000 | 2,552,000 | ||||||||||||||||||||||||||||
Transaction price | 12,500,000 | |||||||||||||||||||||||||||||||
Kyowa Kirin | ||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||||||||
Milestone payment | 0 | 0 | ||||||||||||||||||||||||||||||
Kyowa Kirin | ||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||||||||
Revenues | $ 25,000,000 | $ 2,800,000 | ||||||||||||||||||||||||||||||
Non refundable upfront payment | $ 25,000,000 | |||||||||||||||||||||||||||||||
Milestone payment received | $ 2,800,000 | |||||||||||||||||||||||||||||||
Transaction price | 27,800,000 | |||||||||||||||||||||||||||||||
Development and Regulatory Milestone Events | St Vincent's Hospital Sydney Limited | ||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||||||||
Term after first sale | 10 years | |||||||||||||||||||||||||||||||
Termination notice period | 6 months | |||||||||||||||||||||||||||||||
Development and Regulatory Milestone Events | St Vincent's Hospital Sydney Limited | Subsequent Event | ||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||||||||
Milestone payment | $ 2,300,000 | |||||||||||||||||||||||||||||||
Maximum | Biogen Idec International GmbH | ||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||||||||
Royalty payments | $ 50,000,000 | |||||||||||||||||||||||||||||||
Maximum | Development and Regulatory Milestone Events | St Vincent's Hospital Sydney Limited | ||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||||||||
Revenue recognition milestone method milestone payables | 14,400,000 | 14,400,000 | ||||||||||||||||||||||||||||||
Partnership licensing and royalty revenue | ||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||||||||
Revenues | 891,000 | $ 855,000 | $ 821,000 | $ 854,000 | 886,000 | $ 3,600,000 | $ 749,000 | $ 784,000 | 3,421,000 | 6,019,000 | 28,795,000 | |||||||||||||||||||||
Partnership licensing and royalty revenue | EUSA | ||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||||||||
Revenues | 1,447,000 | 1,245,000 | 861,000 | |||||||||||||||||||||||||||||
License | Kyowa Kirin | ||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||||||||
Revenues | $ 2,800,000 | 0 | 2,800,000 | |||||||||||||||||||||||||||||
Opt In To Planned Phase Three Study | Minimum | EUSA | ||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||||||||
Eusa potential opt-In payment TIVO three trial | 8,700,000 | |||||||||||||||||||||||||||||||
Opt In To Planned Phase Three Study | Maximum | EUSA | ||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||||||||
Research and development reimbursement potential opt-in payment | 20,000,000 | |||||||||||||||||||||||||||||||
Astra Zeneca Agreement | Astra Zeneca Inc. | ||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||||||||
Trade receivables, net | 800,000 | 800,000 | ||||||||||||||||||||||||||||||
FOCAL study | Biodesix | ||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||||||||
Royalty on future product sales, percentage of future licensing revenue | 25.00% | |||||||||||||||||||||||||||||||
Required payment amount for agreement | $ 2,500,000 | |||||||||||||||||||||||||||||||
FOCAL study | Minimum | Biodesix | ||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||||||||
Contribution percentage of clinical, regulatory, manufacturing and other costs | 50.00% | |||||||||||||||||||||||||||||||
Licensing Agreements | ||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||||||||
Collaborations and license agreements, one time milestone payment waived | $ 18,000,000 | |||||||||||||||||||||||||||||||
Collaborations and license agreements, expected milestone receivable | 390,700,000 | |||||||||||||||||||||||||||||||
Term of royalty payment obligations | 10 years | |||||||||||||||||||||||||||||||
Non refundable upfront payment | 25,000,000 | |||||||||||||||||||||||||||||||
Milestone payment received | $ 2,800,000 | |||||||||||||||||||||||||||||||
Aggregate milestone payments | $ 387,900,000 | $ 387,900,000 | ||||||||||||||||||||||||||||||
Licensing Agreements | St Vincent's Hospital Sydney Limited | ||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||||||||
Upfront payment received | $ 1,500,000 | |||||||||||||||||||||||||||||||
Licensing Agreements | Kyowa Kirin | ||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||||||||
Upfront payment receivable | $ 25,000,000 | |||||||||||||||||||||||||||||||
Collaborations and license agreements, one time milestone payment waived | $ 18,000,000 | |||||||||||||||||||||||||||||||
Upfront payment received | $ 5,000,000 | |||||||||||||||||||||||||||||||
Collaborations and license agreements, milestone payment | $ 10,000,000 | |||||||||||||||||||||||||||||||
Licensing Agreements | Kyowa Kirin | ||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||||||||
Collaborations and license agreements, potential future payment as percentage of certain amounts the Company receives under sublicense agreements | 30.00% | 30.00% | ||||||||||||||||||||||||||||||
Term of royalty payment obligations | 12 years | |||||||||||||||||||||||||||||||
Royalties on the net sales | $ 4,700,000 | |||||||||||||||||||||||||||||||
Licensing Agreements | FDA Marketing Approval | Kyowa Kirin | ||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||||||||
Collaborations and license agreements, milestone payment | $ 12,000,000 | |||||||||||||||||||||||||||||||
Research and development | Astra Zeneca Agreement | Astra Zeneca Inc. | ||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||||||||
Payments received and recorded as an increased (decreased) to expense pursuant to cost-sharing provisions | $ 900,000 | $ 1,100,000 | $ 500,000 |
Collaborations and License Ag_4
Collaborations and License Agreements - Summary of Changes in Accounts Receivable and Contract Liabilities (Deferred Revenue) (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2021 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Dec. 31, 2020 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Revenues | $ 17,646 | $ 15,173 | $ 7,556 | $ 1,920 | $ 42,295 | $ 6,019 | $ 28,795 | ||||
Partnership licensing and royalty revenue | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Revenues | 891 | $ 855 | $ 821 | 854 | $ 886 | $ 3,600 | $ 749 | $ 784 | 3,421 | 6,019 | 28,795 |
EUSA | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Revenues | 3,421 | 3,219 | 3,795 | ||||||||
Contract Liabilities | |||||||||||
Transaction Price | 12,500 | ||||||||||
Deferred Revenue | |||||||||||
Beginning balance | 2,552 | 2,552 | |||||||||
Additions | 0 | ||||||||||
Deductions | 1,974 | ||||||||||
Ending balance | 578 | 2,552 | 578 | 2,552 | |||||||
EUSA | Upfront payment | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Collaboration and licensing revenue | 395 | 395 | 395 | ||||||||
Contract Liabilities | |||||||||||
Transaction Price | 2,500 | ||||||||||
Deferred Revenue | |||||||||||
Beginning balance | 512 | 512 | |||||||||
Additions | 0 | ||||||||||
Deductions | 395 | ||||||||||
Ending balance | 117 | 512 | 117 | 512 | |||||||
EUSA | R&D payment - EMA approval in RCC | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Collaboration and licensing revenue | 631 | 631 | 631 | ||||||||
Contract Liabilities | |||||||||||
Transaction Price | 4,000 | ||||||||||
Deferred Revenue | |||||||||||
Beginning balance | 817 | 817 | |||||||||
Additions | 0 | ||||||||||
Deductions | 631 | ||||||||||
Ending balance | 186 | 817 | 186 | 817 | |||||||
EUSA | Milestone - UK reimbursement approval | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Collaboration and licensing revenue | 316 | 316 | 316 | ||||||||
Contract Liabilities | |||||||||||
Transaction Price | 2,000 | ||||||||||
Deferred Revenue | |||||||||||
Beginning balance | 408 | 408 | |||||||||
Additions | 0 | ||||||||||
Deductions | 316 | ||||||||||
Ending balance | 92 | 408 | 92 | 408 | |||||||
EUSA | Milestone - German reimbursement approval | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Collaboration and licensing revenue | 316 | 316 | 316 | ||||||||
Contract Liabilities | |||||||||||
Transaction Price | 2,000 | ||||||||||
Deferred Revenue | |||||||||||
Beginning balance | 407 | 407 | |||||||||
Additions | 0 | ||||||||||
Deductions | 316 | ||||||||||
Ending balance | 91 | 407 | 91 | 407 | |||||||
EUSA | Milestone - Spanish reimbursement approval | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Collaboration and licensing revenue | 316 | 316 | 1,276 | ||||||||
Contract Liabilities | |||||||||||
Transaction Price | 2,000 | ||||||||||
Deferred Revenue | |||||||||||
Beginning balance | 408 | 408 | |||||||||
Additions | 0 | ||||||||||
Deductions | 316 | ||||||||||
Ending balance | 92 | 408 | 92 | 408 | |||||||
EUSA | Collaboration and Licensing Revenue | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Revenues | 1,974 | 1,974 | 2,934 | ||||||||
EUSA | Partnership licensing and royalty revenue | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Revenues | 1,447 | 1,245 | $ 861 | ||||||||
EUSA | Partnership receivables | |||||||||||
Contract Assets | |||||||||||
Beginning balance | $ 392 | 392 | |||||||||
Additions | 1,447 | ||||||||||
Deductions | (1,079) | ||||||||||
Ending balance | $ 760 | $ 392 | $ 760 | $ 392 |
Other Accrued Liabilities (Deta
Other Accrued Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Accrued Liabilities, Current [Abstract] | ||
FOTIVDA U.S. Product Royalties | $ 2,011 | $ 0 |
FOTIVDA Federal Rebates, Customer Credits and Co-Pay Assistance | 1,170 | 0 |
Professional Fees | 1,107 | 1,061 |
Other | 1,133 | 320 |
Total | $ 5,421 | $ 1,381 |
Hercules Loan Facility - Additi
Hercules Loan Facility - Additional Information (Details) | Mar. 08, 2022USD ($) | Mar. 07, 2022USD ($) | Dec. 22, 2021USD ($) | Jul. 01, 2021USD ($) | Mar. 11, 2021USD ($) | Feb. 01, 2021USD ($) | Aug. 07, 2020USD ($)tranche | Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) |
Debt Instrument [Line Items] | ||||||||||
Number of tranches | tranche | 4 | |||||||||
Loan facility received | $ 5,000,000 | |||||||||
Revenues | $ 20,000,000 | |||||||||
Outstanding debt | 790,000 | $ 0 | $ 300,000 | |||||||
Loan issuance costs paid | 85,000 | 255,000 | $ 0 | |||||||
Principal amount | 40,000,000 | |||||||||
Face amount | 2,800,000 | |||||||||
Unamortized discount | $ 2,040,000 | $ 1,200,000 | ||||||||
Subsequent Event | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Loan facility received | $ 5,000,000 | |||||||||
Tranche Two | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Loan facility received | 10,000,000 | |||||||||
Tranche Three | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Loan facility | 5,000,000 | |||||||||
Interest-only extension period | 6 months | |||||||||
Extended loan maturity | 1 year | |||||||||
Tranche Four | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Loan facility | 5,000,000 | |||||||||
2020 Loan Agreement | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Loan facility | 35,000,000 | |||||||||
Secured debt | 9,700,000 | |||||||||
New loan funding received | $ 5,300,000 | |||||||||
Interest rate | 9.65% | |||||||||
Prime interest rate | 3.25% | |||||||||
End-of term payment percentage of loan funding received | 6.95% | |||||||||
Outstanding debt | $ 800,000 | |||||||||
Loan issuance costs paid | 300,000 | |||||||||
Unrestricted cash | $ 5,000,000 | |||||||||
Trailing period for revenue requirements | 6 months | |||||||||
2020 Loan Agreement | Debt Instrument, Redemption, Period One | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Prepayment percentage | 0.03% | |||||||||
2020 Loan Agreement | Debt Instrument, Redemption, Period Two | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Prepayment percentage | 0.02% | |||||||||
2020 Loan Agreement | Debt Instrument, Redemption, Period Three | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Prepayment percentage | 0.01% | |||||||||
2020 Loan Agreement | Tranche One | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Loan facility received | $ 15,000,000 | |||||||||
Hercules Amended Loan Agreement | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Outstanding debt | $ 800,000 | |||||||||
Loan issuance costs paid | $ 100,000 | |||||||||
Hercules Amended Loan Agreement | Tranche Two | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Drawdown amount | $ 20,000,000 | |||||||||
Loan Amendment 2022 | Subsequent Event | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Trailing period for revenue requirements | 6 months | 6 months | ||||||||
Unrestricted cash position | $ 15,000,000 | $ 10,000,000 | ||||||||
Percentage of forecasted net product revenues | 65.00% | 75.00% | ||||||||
Loan Amendment 2022 | Tranche Four | Subsequent Event | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Trailing period for revenue requirements | 3 months | |||||||||
Net revenue achievement threshold | $ 30,000,000 | |||||||||
Minimum | 2020 Loan Agreement | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Interest rate | 9.65% | |||||||||
Unrestricted cash | $ 10,000,000 | |||||||||
Percentage of forecast revenue | 75.00% | |||||||||
Minimum | Hercules Amended Loan Agreement | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Loan facility | $ 35,000,000 | |||||||||
Unrestricted cash | 10,000,000 | |||||||||
Unfunded term loan | 20,000,000 | |||||||||
Unrestricted cash position | 10,000,000 | |||||||||
Minimum | Hercules Amended Loan Agreement | Tranche Two | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Loan facility received | 10,000,000 | |||||||||
Unrestricted cash | 10,000,000 | |||||||||
Minimum | Hercules Amended Loan Agreement | Tranche Three | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Loan facility received | 20,000,000 | |||||||||
Unrestricted cash | $ 15,000,000 | |||||||||
Maximum | 2020 Loan Agreement | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Interest rate | 15.00% | |||||||||
Indebtedness | $ 500,000 | |||||||||
Maximum | Hercules Amended Loan Agreement | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Loan facility | 45,000,000 | |||||||||
Unfunded term loan | 30,000,000 | |||||||||
Unrestricted cash position | $ 10,000,000 | 15,000,000 | ||||||||
Maximum | Hercules Amended Loan Agreement | Tranche Two | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Loan facility received | 20,000,000 | |||||||||
Maximum | Hercules Amended Loan Agreement | Tranche Three | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Loan facility received | $ 35,000,000 |
Hercules Loan Facility - Future
Hercules Loan Facility - Future Minimum Payments Under Loans Payable (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Debt Disclosure [Abstract] | ||
2022 | $ 3,885 | |
2023 | 22,528 | |
2024 | 24,406 | |
Long-term debt, gross | 50,819 | |
Less amount representing interest | (8,039) | |
Less unamortized discount | (2,040) | $ (1,200) |
Less deferred charges | (2,780) | |
Less loans payable current, net of discount | 0 | (1,056) |
Loans payable, net of current portion and discount | $ 37,960 | $ 12,716 |
Common Stock (Details)
Common Stock (Details) | May 16, 2021USD ($)$ / sharesshares | Mar. 26, 2021USD ($)$ / sharesshares | Jun. 19, 2020USD ($)affiliate$ / sharesshares | Feb. 19, 2020shares | Feb. 13, 2020 | Mar. 31, 2021USD ($)shares | Nov. 30, 2020USD ($)shares | Apr. 30, 2019USD ($)$ / sharesshares | Feb. 28, 2019USD ($)shares | May 31, 2016USD ($)$ / sharesshares | Mar. 31, 2021USD ($)shares | Dec. 31, 2018USD ($)shares | Dec. 31, 2021USD ($)$ / sharesshares | Dec. 31, 2020USD ($)$ / sharesshares | Dec. 31, 2019USD ($)shares | Apr. 08, 2021$ / sharesshares | Nov. 09, 2020USD ($) | Feb. 18, 2020shares | Feb. 28, 2018USD ($) |
Class Of Stock [Line Items] | |||||||||||||||||||
Common stock, shares authorized (in shares) | shares | 50,000,000 | 50,000,000 | 50,000,000 | 500,000,000 | |||||||||||||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.001 | $ 0.001 | |||||||||||||||||
Common stock, shares issued (in shares) | shares | 6,900,000 | 16,100,000 | 247,391 | 247,391 | 34,474,710 | 26,883,000 | 160,800,000 | ||||||||||||
Common stock, shares outstanding (in shares) | shares | 16,100,000 | 34,474,710 | 26,883,000 | 160,800,000 | |||||||||||||||
Warrants to purchase of common stock shares (in shares) | shares | 2,252,609 | ||||||||||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ | $ 55,200,000 | $ 55,095,000 | $ 29,996,000 | $ 25,279,000 | |||||||||||||||
Net proceeds from public offering | $ | $ 51,700,000 | ||||||||||||||||||
Common stock value available for issuance in connection with future stock sales | $ | $ 213,000,000 | ||||||||||||||||||
Conversion ratio | 0 | ||||||||||||||||||
Gross proceeds from common stock and warrant issued | $ | $ 3,100,000 | ||||||||||||||||||
Warrants exercise price (in dollars per share) | $ / shares | $ 12.50 | ||||||||||||||||||
Stock price (in dollars per share) | $ / shares | $ 4.69 | $ 7.01 | |||||||||||||||||
Common stock sales agreement, aggregate offering amount | $ | $ 34,000 | 27,000 | |||||||||||||||||
Proceeds from issuance of common stock and warrants to related parties | $ | 0 | 23,644,000 | 5,000,000 | ||||||||||||||||
Proceeds from warrant exercises | $ | 3,092,000 | $ 0 | $ 0 | ||||||||||||||||
Leerink Capital Partners LLC | |||||||||||||||||||
Class Of Stock [Line Items] | |||||||||||||||||||
Common stock value available for issuance in connection with future stock sales | $ | $ 22,200,000 | ||||||||||||||||||
Stock issued during period, shares (in shares) | shares | 470,777 | ||||||||||||||||||
Net proceeds from issuance of common stock | $ | $ 10,300,000 | ||||||||||||||||||
Leerink Capital Partners LLC | Common Stock | |||||||||||||||||||
Class Of Stock [Line Items] | |||||||||||||||||||
Stock issued during period, shares (in shares) | shares | 330,688 | 1,070,175 | 1,251,555 | ||||||||||||||||
Net proceeds from issuance of common stock | $ | $ 3,400,000 | $ 5,900,000 | $ 7,500,000 | ||||||||||||||||
Over Allotment Option | |||||||||||||||||||
Class Of Stock [Line Items] | |||||||||||||||||||
Warrants to purchase of common stock shares (in shares) | shares | 900,000 | 1,225,000 | |||||||||||||||||
Over Allotment Option | Offering Warrants | |||||||||||||||||||
Class Of Stock [Line Items] | |||||||||||||||||||
Warrants to purchase of common stock shares (in shares) | shares | 326,086 | ||||||||||||||||||
Underwritten Public Offering | |||||||||||||||||||
Class Of Stock [Line Items] | |||||||||||||||||||
Common stock, shares issued (in shares) | shares | 9,725,000 | 2,173,913 | |||||||||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ | $ 51,100,000 | ||||||||||||||||||
Net proceeds from public offering | $ | $ 47,700,000 | $ 22,800,000 | |||||||||||||||||
Number of affiliates stockholders | affiliate | 3 | ||||||||||||||||||
Percentage of affiliates stockholders | 5.00% | ||||||||||||||||||
Number of other stockholders | affiliate | 2 | ||||||||||||||||||
Gross proceeds from common stock and warrant issued | $ | $ 25,000,000 | ||||||||||||||||||
Percentage of beneficial ownership of voting securities | 5.00% | ||||||||||||||||||
Underwritten Public Offering | Offering Warrants | |||||||||||||||||||
Class Of Stock [Line Items] | |||||||||||||||||||
Warrants to purchase of common stock shares (in shares) | shares | 2,500,000 | ||||||||||||||||||
Warrants exercise price (in dollars per share) | $ / shares | $ 12.50 | ||||||||||||||||||
Warrants exercisable period | 2 years | ||||||||||||||||||
Warrants exercisable period | 2 years | ||||||||||||||||||
Underwritten Public Offering | New Enterprise Associates and Another Stockholder | |||||||||||||||||||
Class Of Stock [Line Items] | |||||||||||||||||||
Common stock, shares issued (in shares) | shares | 4,503,571 | ||||||||||||||||||
Underwritten Public Offering | Other Investors | |||||||||||||||||||
Class Of Stock [Line Items] | |||||||||||||||||||
Common stock, shares issued (in shares) | shares | 434,782 | ||||||||||||||||||
Underwritten Public Offering | Other Investors | Offering Warrants | |||||||||||||||||||
Class Of Stock [Line Items] | |||||||||||||||||||
Warrants to purchase of common stock shares (in shares) | shares | 434,782 | ||||||||||||||||||
Private Placement | |||||||||||||||||||
Class Of Stock [Line Items] | |||||||||||||||||||
Common stock, shares issued (in shares) | shares | 54,402 | 1,764,242,000 | |||||||||||||||||
Shares issued, price per share (in dollars per share) | $ / shares | $ 9.65 | ||||||||||||||||||
Warrants exercise price (in dollars per share) | $ / shares | $ 10 | ||||||||||||||||||
Warrants exercisable period | 5 years | ||||||||||||||||||
Gross proceeds from issuance of private placement | $ | $ 17,000,000 | ||||||||||||||||||
Exchange of unit to share (in shares) | shares | 1 | ||||||||||||||||||
Warrants exercisable period | 5 years | ||||||||||||||||||
Proceeds from issuance of common stock and warrants to related parties | $ | $ 15,400,000 | ||||||||||||||||||
Warrants exercisable shares of common stock exercised (in shares) | shares | 80,309 | ||||||||||||||||||
Proceeds from warrant exercises | $ | $ 800,000 | ||||||||||||||||||
Warrants exercisable shares of common stock outstanding (in shares) | shares | 1,683,933 | ||||||||||||||||||
Private Placement | Common Stock | |||||||||||||||||||
Class Of Stock [Line Items] | |||||||||||||||||||
Stock issued during period, shares (in shares) | shares | 331,000 | 1,070,000 | 1,251,000 | ||||||||||||||||
Minimum | |||||||||||||||||||
Class Of Stock [Line Items] | |||||||||||||||||||
Shares issued, price per share (in dollars per share) | $ / shares | $ 8 | $ 5.25 | |||||||||||||||||
Conversion ratio | 0.2 | ||||||||||||||||||
Minimum | Underwritten Public Offering | |||||||||||||||||||
Class Of Stock [Line Items] | |||||||||||||||||||
Shares issued, price per share (in dollars per share) | $ / shares | $ 11.40 | ||||||||||||||||||
Minimum | Underwritten Public Offering | Offering Warrants | |||||||||||||||||||
Class Of Stock [Line Items] | |||||||||||||||||||
Shares issued, price per share (in dollars per share) | $ / shares | $ 0.10 | ||||||||||||||||||
Maximum | |||||||||||||||||||
Class Of Stock [Line Items] | |||||||||||||||||||
Offering, issuance and sale of stocks and securities, shelf registration | $ | $ 300,000,000 | ||||||||||||||||||
Conversion ratio | 0.067 | ||||||||||||||||||
Maximum | Leerink Capital Partners LLC | |||||||||||||||||||
Class Of Stock [Line Items] | |||||||||||||||||||
Common stock sales agreement, aggregate offering amount | $ | $ 50,000,000 | ||||||||||||||||||
Common stock sales agreement commission, percentage | 3.00% |
Stock-based Compensation - Addi
Stock-based Compensation - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | |||||||||||
Jun. 30, 2021 | Apr. 30, 2021 | Apr. 30, 2020 | Apr. 30, 2019 | Feb. 28, 2010 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 14, 2021 | Apr. 08, 2021 | Dec. 01, 2020 | Nov. 30, 2020 | Dec. 01, 2019 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||||
Increase in number of shares reserved (in shares) | 2,200,000 | 1,300,000 | |||||||||||
Stock price (in dollars per share) | $ 4.69 | $ 7.01 | |||||||||||
Total unrecognized stock-based compensation expense related to stock options granted | $ 10,100 | ||||||||||||
Stock-based compensation expense | $ 5,142 | $ 2,355 | $ 2,358 | ||||||||||
2019 Equity Incentive Plan | |||||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||||
Shares of common stock available for future issuance (in shares) | 2,401,114 | ||||||||||||
2019 Equity Incentive Plan | Maximum | |||||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||||
Share of common stock authorized (in shares) | 4,500,000 | ||||||||||||
Common stock reserved for issuance (in shares) | 1,068,901 | ||||||||||||
Employee Stock Purchase Plan, 2010 | |||||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||||
Shares of common stock available for future issuance (in shares) | 0 | ||||||||||||
Stock Options | |||||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||||
Awards, vesting period | 4 years | ||||||||||||
Awards, expiration period | 10 years | ||||||||||||
Weighted-average grant date fair value of stock options granted (in dollars per share) | $ 6.49 | $ 4.54 | $ 5.70 | ||||||||||
Total unrecognized stock-based compensation expense, weighted-average period Recognition | 2 years 10 months 17 days | ||||||||||||
Stock Options | Minimum | Participants Who Own Less Than Ten Percent Of Combined Voting Power | |||||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||||
Exercise price of incentive stock options as percentage of fair market value of common stock on the date of the award | 100.00% | ||||||||||||
Stock Options | Maximum | Participants Who Own More than 10% of Total Combined Voting Power | |||||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||||
Exercise price of incentive stock options as percentage of fair market value of common stock on the date of the award | 110.00% | ||||||||||||
Employee Stock | |||||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||||
Increase in number of shares reserved (in shares) | 500,000 | ||||||||||||
Share of common stock authorized (in shares) | 576,400 | ||||||||||||
Purchase price of common stock, percentage | 85.00% | 85.00% | |||||||||||
Purchase period | 6 months | ||||||||||||
Shares reserved for issuance (in shares) | 412,403 | ||||||||||||
Share sold in period (in shares) | 111,456 | 5,971 | 0 | ||||||||||
Purchase price of shares (in dollars per share) | $ 4.40 | $ 4.38 | $ 4.57 | $ 6.46 | |||||||||
Stock-based compensation expense | $ 300 | $ 0 | $ 0 |
Stock-based Compensation - Stoc
Stock-based Compensation - Stock Option Activity (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Options | ||
Outstanding at beginning of period (in shares) | 1,816,690 | |
Granted (in shares) | 1,751,218 | |
Exercised (in shares) | (2,479) | |
Forfeited (in shares) | (409,050) | |
Outstanding at end of period (in shares) | 3,156,379 | 1,816,690 |
Exercisable (in shares) | 1,357,101 | |
Weighted-Average Exercise Price | ||
Outstanding at beginning of period (in dollars per share) | $ 11.04 | |
Granted (in dollars per share) | 8.37 | |
Exercised (in dollars per share) | 5.97 | |
Forfeited (in dollars per share) | 11.87 | |
Outstanding at end of period (in dollars per share) | 9.45 | $ 11.04 |
Exercisable (in dollars per share) | $ 11.72 | |
Weighted-Average Remaining Contractual Term | ||
Outstanding | 7 years 6 months 18 days | 7 years 6 months 10 days |
Exercisable | 5 years 9 months 25 days | |
Aggregate Intrinsic Value | ||
Outstanding | $ 5,720 | $ 170,000 |
Exercisable | $ 1,907 |
Stock-based Compensation - Assu
Stock-based Compensation - Assumptions Used in Black Scholes Pricing Model for New Grants (Details) - Stock Options | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Volatility factor, minimum | 56.17% | 94.37% | 88.27% |
Volatility factor, maximum | 102.66% | 102.48% | 98.81% |
Risk-free interest rates, minimum | 0.06% | 0.31% | 1.43% |
Risk-free interest rates, maximum | 1.33% | 1.67% | 2.55% |
Dividend yield | 0.00% | 0.00% | 0.00% |
Minimum | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Expected term (in years) | 3 months | 5 years 6 months | 5 years 6 months |
Maximum | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Expected term (in years) | 6 years 3 months | 6 years 3 months | 6 years 3 months |
Commitment and Contingencies (D
Commitment and Contingencies (Details) $ in Millions | Nov. 17, 2021USD ($)ft² | Mar. 05, 2020USD ($)ft²$ / ft² | Dec. 31, 2021USD ($)ft² | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) |
Other Commitments [Line Items] | |||||
Rental area per square foot (in dollars per sq. ft) | $ / ft² | 47 | ||||
Annual base rent of lease | $ 0.5 | ||||
Percentage increase in annual base rent | 3.00% | ||||
Rentable space | ft² | 6,465 | 10,158 | 300,000 | ||
Security deposit | $ 0.3 | ||||
Rent expense | $ 0.6 | $ 0.6 | $ 0.8 | ||
Manufacturing commitment | 9 | ||||
License Fee Obligations | |||||
Other Commitments [Line Items] | |||||
Other commitment | 2 | ||||
Minimum | |||||
Other Commitments [Line Items] | |||||
Minimum annual purchase requirements | 0.5 | ||||
Manufacturing commitment in 2022 | $ 1.4 | ||||
Severance payment period | 12 months | ||||
Change in control period | 9 months | ||||
Minimum | Chief Executive Officer | |||||
Other Commitments [Line Items] | |||||
Severance payment period | 12 months | ||||
Maximum | |||||
Other Commitments [Line Items] | |||||
Severance payment period | 18 months | ||||
Change in control period | 24 months |
Income Taxes - Narrative (Detai
Income Taxes - Narrative (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Contingency [Line Items] | ||
Tax provision | $ 0 | $ 0 |
Increase (decrease) valuation allowance | 13,300,000 | $ 10,900,000 |
Interest and penalties | 0 | |
Internal Revenue Service (IRS) | ||
Income Tax Contingency [Line Items] | ||
Net operating losses | 613,100,000 | |
Tax credit carryforwards | 12,700,000 | |
United Kingdom | ||
Income Tax Contingency [Line Items] | ||
Net operating losses | 6,000,000 | |
Domestic Tax Authority | ||
Income Tax Contingency [Line Items] | ||
Net operating losses | 508,400,000 | |
State and Local Jurisdiction | ||
Income Tax Contingency [Line Items] | ||
Tax credit carryforwards | 4,300,000 | |
Domestic Federal | ||
Income Tax Contingency [Line Items] | ||
Net operating losses | $ 110,500,000 |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Income Tax (Details) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |||
Income tax computed at federal statutory tax rate | 21.00% | 21.00% | 21.00% |
State taxes, net of federal benefit | 3.60% | 6.70% | 1.30% |
Research and development credits | 1.60% | 1.50% | (4.20%) |
PIPE Warrants | 0.10% | 2.90% | (25.90%) |
Other permanent differences | (0.90%) | (0.50%) | 1.80% |
Other | (0.50%) | (1.10%) | 5.70% |
Change in valuation allowance | (24.90%) | (30.50%) | 0.30% |
Effective tax rate | 0.00% | 0.00% | 0.00% |
Income Taxes - Deferred Tax Ass
Income Taxes - Deferred Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Deferred tax assets: | ||
NOL carryforwards | $ 160,833 | $ 148,689 |
Research and development credits | 16,088 | 15,271 |
Deferred revenue and R&D reimbursements | 149 | 742 |
Other temporary differences | 5,930 | 5,001 |
Total deferred tax assets: | 183,000 | 169,703 |
Valuation allowance | (183,000) | (169,703) |
Total | $ 0 | $ 0 |
Income Taxes - Reconciliation_2
Income Taxes - Reconciliation of Uncertain Tax Positions (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |||
Amount established upon adoption | $ 1,078 | $ 1,200 | $ 1,200 |
Additions for current year tax provisions | 0 | 0 | 0 |
Additions for prior year tax provisions | 0 | 0 | 0 |
Reductions of prior year tax provisions | (113) | (122) | 0 |
Balance as of end of year | $ 965 | $ 1,078 | $ 1,200 |
Employee Benefit Plan (Details)
Employee Benefit Plan (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Retirement Benefits [Abstract] | |||
Employer match percentage | 50.00% | ||
Employer match of employee gross pay | 5.00% | ||
Matching contribution costs | $ 0.1 | $ 0.1 |
Quarterly Results (Unaudited)_2
Quarterly Results (Unaudited) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2021 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Dec. 31, 2020 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Revenues: | |||||||||||
Revenues | $ 17,646 | $ 15,173 | $ 7,556 | $ 1,920 | $ 42,295 | $ 6,019 | $ 28,795 | ||||
Operating expenses: | |||||||||||
Cost of products sold | $ 2,033 | $ 1,744 | $ 822 | $ 138 | $ 4,737 | $ 0 | $ 0 | ||||
Cost, product and service, extensible enumeration | FOTIVDA U.S. product revenue, net | FOTIVDA U.S. product revenue, net | FOTIVDA U.S. product revenue, net | FOTIVDA U.S. product revenue, net | FOTIVDA U.S. product revenue, net | FOTIVDA U.S. product revenue, net | FOTIVDA U.S. product revenue, net | ||||
Research and development | $ 6,121 | $ 7,502 | $ 6,878 | $ 5,797 | $ 4,574 | $ 5,860 | $ 4,419 | $ 7,826 | $ 26,298 | $ 22,679 | $ 17,958 |
Selling, general and administrative | 15,652 | 15,142 | 14,920 | 15,100 | 9,008 | 5,800 | 3,737 | 3,672 | 60,814 | 22,217 | 11,211 |
Operating expenses | 23,806 | 24,388 | 22,620 | 21,035 | 13,582 | 11,660 | 8,156 | 11,498 | 91,849 | 44,896 | 29,169 |
Loss from operations | (6,160) | (9,215) | (15,064) | (19,115) | (12,696) | (8,060) | (7,407) | (10,714) | (49,554) | (38,877) | (374) |
Other income (expense), net: | |||||||||||
Interest expense, net | (1,153) | (1,153) | (1,128) | (611) | (522) | (419) | (349) | (315) | (4,045) | (1,605) | (1,815) |
Change in fair value of PIPE Warrant liability | 0 | 0 | 2,595 | (2,396) | 1,714 | 86 | 450 | 2,648 | 199 | 4,898 | 11,577 |
Other income | 58 | 0 | 0 | 0 | 58 | 0 | 0 | ||||
Other income (expense), net | (1,095) | (1,153) | 1,467 | (3,007) | 1,192 | (333) | 101 | 2,333 | (3,788) | 3,293 | 9,762 |
Net income (loss) | $ (7,255) | $ (10,368) | $ (13,597) | $ (22,122) | $ (11,504) | $ (8,393) | $ (7,306) | $ (8,381) | $ (53,342) | $ (35,584) | $ 9,388 |
Net income (loss) per share (in dollars per share) | $ (0.21) | $ (0.30) | $ (0.40) | $ (0.81) | $ (0.44) | $ (0.33) | $ (0.42) | $ (0.52) | $ (1.63) | $ (1.66) | $ 0.61 |
Net income (loss) per share (in dollars per share) | $ (0.21) | $ (0.30) | $ (0.40) | $ (0.81) | $ (0.44) | $ (0.33) | $ (0.42) | $ (0.52) | $ (1.63) | $ (1.66) | $ 0.61 |
Weighted average number of common shares outstanding (in shares) | 34,384,000 | 34,374,000 | 34,362,000 | 27,429,000 | 26,252,000 | 25,808,000 | 17,364,000 | 16,081,000 | 32,661,000 | 21,402,000 | 15,331,000 |
Weighted average number of common shares outstanding (in shares) | 34,384,000 | 34,374,000 | 34,362,000 | 27,429,000 | 26,252,000 | 25,808,000 | 17,364,000 | 16,081,000 | 32,661,000 | 21,402,000 | 15,376,000 |
FOTIVDA U.S. product revenue, net | |||||||||||
Revenues: | |||||||||||
Revenues | $ 16,755 | $ 14,318 | $ 6,735 | $ 1,066 | $ 38,874 | $ 0 | $ 0 | ||||
Partnership licensing and royalty revenue | |||||||||||
Revenues: | |||||||||||
Revenues | $ 891 | $ 855 | $ 821 | $ 854 | $ 886 | $ 3,600 | $ 749 | $ 784 | $ 3,421 | $ 6,019 | $ 28,795 |