Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2022 | May 02, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2022 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q1 | |
Trading Symbol | EIGR | |
Entity Registrant Name | Eiger BioPharmaceuticals, Inc. | |
Entity Central Index Key | 0001305253 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Common Stock, Shares Outstanding | 43,216,126 | |
Entity Current Reporting Status | Yes | |
Entity Shell Company | false | |
Entity File Number | 001-36183 | |
Entity Tax Identification Number | 33-0971591 | |
Entity Address, Address Line One | 2155 Park Boulevard | |
Entity Address, City or Town | Palo Alto | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 94306 | |
City Area Code | 650 | |
Local Phone Number | 272-6138 | |
Entity Interactive Data Current | Yes | |
Title of 12(b) Security | Common Stock (par value $0.001 per share) | |
Security Exchange Name | NASDAQ | |
Entity Incorporation, State or Country Code | DE | |
Document Quarterly Report | true | |
Document Transition Report | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 46,562 | $ 22,221 |
Short-term debt securities | 86,155 | 66,594 |
Accounts receivable, net | 2,287 | 2,576 |
Inventories | 1,910 | 2,612 |
Prepaid expenses and other current assets | 10,442 | 9,361 |
Total current assets | 147,356 | 103,364 |
Long-term debt securities | 17,262 | |
Property and equipment, net | 545 | 613 |
Operating lease right-of-use assets | 521 | 653 |
Other assets | 4,907 | 4,510 |
Total assets | 153,329 | 126,402 |
Current liabilities: | ||
Accounts payable | 9,218 | 7,765 |
Accrued liabilities | 14,255 | 13,699 |
Current portion of operating lease liabilities | 590 | 628 |
Current portion of long-term debt, net | 12,549 | 7,809 |
Total current liabilities | 36,612 | 29,901 |
Long-term debt, net | 19,446 | 23,986 |
Operating lease liabilities | 4 | 116 |
Total liabilities | 56,062 | 54,003 |
Stockholders’ equity: | ||
Common stock | 41 | 35 |
Additional paid-in capital | 460,808 | 412,930 |
Accumulated other comprehensive loss | (522) | (149) |
Accumulated deficit | (363,060) | (340,417) |
Total stockholders’ equity | 97,267 | 72,399 |
Total liabilities and stockholders’ equity | $ 153,329 | $ 126,402 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Income Statement [Abstract] | ||
Product revenue, net | $ 2,673,000 | $ 3,646,000 |
Costs and operating expenses: | ||
Cost of sales | 110,000 | 53,000 |
Research and development | 17,570,000 | 13,842,000 |
Selling, general and administrative | 6,813,000 | 5,564,000 |
Total costs and operating expenses | 24,493,000 | 19,459,000 |
Loss from operations | (21,820,000) | (15,813,000) |
Interest expense | (886,000) | (885,000) |
Interest income | 45,000 | 51,000 |
Other income, net | 27,000 | 45,914,000 |
(Loss) income before provision for income taxes | (22,634,000) | 29,267,000 |
Provision for income taxes | 9,000 | 19,000 |
Net (loss) income | $ (22,643,000) | $ 29,248,000 |
Net (loss) income per common share: | ||
Basic | $ (0.64) | $ 0.86 |
Diluted | $ (0.64) | $ 0.85 |
Weighted-average common shares outstanding: | ||
Basic | 35,253,147 | 33,886,896 |
Diluted | 35,253,147 | 34,220,895 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive (Loss) Income (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Statement Of Income And Comprehensive Income [Abstract] | ||
Net (loss) income | $ (22,643) | $ 29,248 |
Other comprehensive (loss) income: | ||
Unrealized (loss) gain on available-for-sale debt securities, net | (373) | 3 |
Comprehensive (loss) income | $ (23,016) | $ 29,251 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders' Equity (Unaudited) - USD ($) $ in Thousands | Total | Common Stock [Member] | Additional Paid-In Capital [Member] | Accumulated Other Comprehensive (Loss) Income [Member] | Accumulated Deficit [Member] |
Balance at Dec. 31, 2020 | $ 95,035 | $ 34 | $ 401,509 | $ (8) | $ (306,500) |
Balance, beginning of period, Shares at Dec. 31, 2020 | 33,878,486 | ||||
Issuance of common stock upon exercise of stock options | 166 | 166 | |||
Issuance of common stock upon exercise of stock options, Shares | 19,150 | ||||
Vesting of common stock issued under Product Development Agreement | 53 | 53 | |||
Issuance of common stock upon ESPP purchase | 136 | 136 | |||
Issuance of common stock upon ESPP purchase, Shares | 19,928 | ||||
Issuance of common stock upon release of restricted stock units, Shares | 33,750 | ||||
Stock-based compensation expense | 1,549 | 1,549 | |||
Unrealized (loss) gain on available-for-sale debt securities, net | 3 | 3 | |||
Net (loss) income | 29,248 | 29,248 | |||
Balance at Mar. 31, 2021 | 126,190 | $ 34 | 403,413 | (5) | (277,252) |
Balance, end of period, Shares at Mar. 31, 2021 | 33,951,314 | ||||
Balance at Dec. 31, 2021 | 72,399 | $ 35 | 412,930 | (149) | (340,417) |
Balance, beginning of period, Shares at Dec. 31, 2021 | 34,568,821 | ||||
Issuance of common stock upon offering at-the-market, net of commissions | 45,610 | $ 6 | 45,604 | ||
Issuance of common stock upon offering at-the-market, net of commissions, shares | 5,841,786 | ||||
Issuance of common stock upon exercise of stock options | $ 144 | 144 | |||
Issuance of common stock upon exercise of stock options, Shares | 15,995 | 15,995 | |||
Vesting of common stock issued under Product Development Agreement | $ 19 | 19 | |||
Issuance of common stock upon ESPP purchase | 64 | 64 | |||
Issuance of common stock upon ESPP purchase, Shares | 18,130 | ||||
Issuance of common stock upon release of restricted stock units, Shares | 85,106 | ||||
Stock-based compensation expense | 2,047 | 2,047 | |||
Unrealized (loss) gain on available-for-sale debt securities, net | (373) | (373) | |||
Net (loss) income | (22,643) | (22,643) | |||
Balance at Mar. 31, 2022 | $ 97,267 | $ 41 | $ 460,808 | $ (522) | $ (363,060) |
Balance, end of period, Shares at Mar. 31, 2022 | 40,529,838 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity (Parenthetical) $ in Thousands | 3 Months Ended |
Mar. 31, 2022USD ($) | |
Statement Of Stockholders Equity [Abstract] | |
Issuance of common stock upon public offering, commissions | $ 1,288 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flow (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Operating activities | ||
Net (loss) income | $ (22,643) | $ 29,248 |
Adjustments to reconcile net (loss) income to net cash used in operating activities: | ||
Gain from sale of priority review voucher | (46,493) | |
Income related to asset purchase agreement | (281) | |
Depreciation and amortization | 73 | 67 |
Stock-based compensation | 2,047 | 1,549 |
Amortization of debt securities premiums and discounts | 330 | 191 |
Non-cash interest expense | 200 | 199 |
Amortization of operating lease right-of-use assets | 132 | 127 |
Common stock issued under Product Development Agreement | 19 | 53 |
Change in operating assets and liabilities: | ||
Accounts receivable | 289 | (639) |
Inventories | 666 | (1,304) |
Prepaid expenses and other current assets | (854) | 1,529 |
Other assets | (397) | (18) |
Accounts payable | 1,269 | 3,175 |
Accrued liabilities | 560 | (2,205) |
Operating lease liabilities | (150) | (131) |
Net cash used in operating activities | (18,459) | (14,933) |
Investing activities | ||
Purchase of debt securities available-for-sale | (10,902) | (2,049) |
Proceeds from maturities of debt securities available-for-sale | 7,900 | 49,755 |
Proceeds from sale of priority review voucher | 95,000 | |
Payments related to priority review voucher | (48,507) | |
Proceeds related to asset purchase agreement | 281 | |
Purchase of property and equipment | (16) | |
Net cash (used in) provided by investing activities | (3,002) | 94,464 |
Financing activities | ||
Issuance of common stock upon offering at-the-market, net of commissions | 45,610 | |
Proceeds from issuance of common stock upon stock option exercises | 144 | 166 |
Proceeds from issuance of common stock upon ESPP purchase | 64 | 146 |
Common stock offering costs | (16) | (122) |
Payment of debt issuance costs | (175) | |
Net cash provided by financing activities | 45,802 | 15 |
Net increase in cash and cash equivalents | 24,341 | 79,546 |
Cash and cash equivalents at beginning of period | 22,221 | 28,864 |
Cash and cash equivalents at end of period | 46,562 | 108,410 |
Supplemental disclosure of cash flow information: | ||
Interest paid | 686 | $ 686 |
Income taxes paid | $ 41 |
Description of Business
Description of Business | 3 Months Ended |
Mar. 31, 2022 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Description of Business | 1. Description of Business Eiger BioPharmaceuticals, Inc. (the Company or Eiger) was incorporated in the State of Delaware on November 6, 2008. Eiger is a commercial-stage biopharmaceutical company focused on the development of innovative therapies to treat and cure Hepatitis Delta Virus (HDV), the most severe form of viral hepatitis, and other serious diseases. All five of the Company’s rare disease programs have FDA Breakthrough Therapy Designation. The Eiger HDV platform includes two first-in-class therapies in Phase 3 that target critical host processes involved in viral replication. Lonafarnib is a first-in-class oral farnesylation inhibitor and peginterferon lambda (lambda) is a first-in-class, type III, well-tolerated interferon. Both lonafarnib and lambda are in global Phase 3 trials. Eiger is also developing lambda for COVID-19 and is preparing to submit an emergency use authorization to FDA based on data from a Phase 3 investigator sponsored study. The FDA approved the Company’s first commercial product, Zokinvy (lonafarnib) for treatment of Progeria and processing-deficient progeroid laminopathies, ultra-rare and rapidly fatal genetic conditions of accelerated aging in children, on November 20, 2020. Eiger’s Marketing Authorization Application (MAA) is under review with the European Medicines Agency (EMA), with a CHMP opinion expected in the first half of 2022 . The Company is also developing avexitide, a well-characterized peptide, as a treatment for congenital hyperinsulinism (HI), an ultra-rare pediatric metabolic disorder and post-bariatric hypoglycemia (PBH), a debilitating and potentially life-threatening condition for which there is currently no approved therapy. The Company’s principal operations are based in Palo Alto, California and it operates in one segment. Liquidity As of March 31, 2022, the Company had $132.7 million of cash, cash equivalents and short-term securities, comprised of $46.6 million of cash and cash equivalents and $86.1 million of short-term debt securities available-for-sale. The Company had an accumulated deficit of $363.1 million and negative cash flows from operating activities as of March 31, 2022. As the Company continues to incur losses, its transition to profitability will depend on the successful development, approval, and commercialization of product candidates and on the achievement of sufficient revenues to support its cost structure. The Company may never achieve profitability, and until it does, the Company will need to continue to raise additional capital Management believes that the currently available resources will be sufficient to fund its planned operations for at least the next 12 months following the issuance date of these condensed consolidated financial statements. However, if the Company’s anticipated operating results are not achieved in future periods, the Company believes that planned expenditures may need to be reduced or it would be required to raise funding in order to fund the operations. Additionally, the Company’s ability to raise additional capital may be adversely impacted by potential worsening global economic conditions and disruptions to, and volatility in, the credit and financial markets in the United States and worldwide resulting from the ongoing COVID-19 pandemic. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The unaudited condensed consolidated financial statements include the accounts of Eiger BioPharmaceuticals, Inc. and its wholly owned subsidiaries, EBPI Merger Inc., EB Pharma LLC, Eiger BioPharmaceuticals Europe Limited, and EigerBio Europe Limited, have been prepared in accordance with accounting principles generally accepted in the United States of America, (U.S. GAAP) and follow the requirements of the Securities and Exchange Commission (the “SEC”) for annual reporting. All intercompany balances and transactions have been eliminated in consolidation. Use of Estimates The preparation of unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. On an ongoing basis, the Company evaluates its estimates. The Company bases its estimates on historical experience and on various other market-specific and relevant assumptions that the Company believes to be reasonable under the circumstances. Actual results could differ from those estimates. Debt Securities Short-term securities consist of debt securities classified as available-for-sale and have maturities greater than 90 days, but less than 365 days from the date of acquisition. Long-term securities consist of debt securities classified as available-for-sale and have maturities greater than 365 days from the date of acquisition. All short-term and long-term securities are carried at fair value based upon quoted market prices. Unrealized gains and losses on available-for-sale securities are excluded from earnings and are reported as a component of accumulated other comprehensive (loss) income. The cost of available-for-sale securities sold is based on the specific-identification method . Accounts Receivable Accounts receivable represent amounts billed to the Company’s customers, net of an allowance for doubtful accounts. Trade accounts receivable are recorded at invoiced amounts and do not bear interest. The expectation of collectability is based on a review of credit profiles of customers, contractual terms and conditions, current economic trends, and historical payment experience. The Company regularly reviews the adequacy of the allowance for doubtful accounts by considering the age of each outstanding invoice and the collection history of each customer to determine the appropriate amount of allowance for doubtful accounts. The Company had no allowance as of March 31, 2022 and 2021. The Company had no bad debt expense for the three months ended March 31, 2022 and 2021. Inventories Inventories are stated at the lower of cost, determined based on actual costs, or estimated net realizable value, on a first-in, first-out basis. Inventories consist of raw materials, work-in-process, and finished goods. Prior to regulatory approval of the Company’s product candidates, expenses incurred to manufacture drug products are recorded as research and development expense. The Company begins capitalizing these expenses as inventory upon regulatory approval. The Company periodically assesses the recoverability of its inventory and reduces the carrying value of the inventory when items are determined to be obsolete, defective or in excess of forecasted sales requirements. Inventory write-downs for excess, defective, and obsolete inventory are recorded as a cost of sales. There have been no write-downs of inventories for the periods presented. Revenue Recognition The Company recognizes revenue upon transfer of control of promised products to customers in an amount that reflects the consideration it expects to receive in exchange for those products. Product Revenue The Company’s product revenue consists of sales of Zokinvy, which received FDA approval in November 2020 and was launched commercially in the United States in January 2021. Prior to 2021, the Company had no product revenue. In the United States, the Company sells Zokinvy to a single specialty pharmacy provider that subsequently dispenses the product directly to patients. The Company discloses revenue on a total basis without further disaggregation. Additionally, the Company does not have any contract assets or liabilities, other than accounts receivable, related to its product revenue. In June 2021, the French National Agency for Medicines and Health Products Safety (ANSM) granted Zokinvy (lonafarnib) a Temporary Authorizations for Use (Autorisation Temporaire d'Utilisation or ATU) for an early access program for a term of one year. In the context of this program, the Company sells product to a distributor who in turn ships product to pharmacies after receiving requests from physicians for patients in France. In November 2021, the Company began distributing and recognizing revenue from sales of Zokinvy (lonafarnib) through a reimbursed early access program in France. There was no revenue from sale of product under the ATU program for the three months ended March 31, 2022. The Company recognizes product revenue when a customer obtains control of its product, which occurs at a point in time, typically upon delivery to a customer as the delivery of the product is the Company’s only performance obligation. Shipping and handling activities are fulfillment activities rather than a separate performance obligation and are recorded in cost of sales. Product revenue is recorded at the net sales price (transaction price), which includes estimates of variable consideration resulting from rebates, prompt payment discounts, co-payment assistance, and returns. Amounts related to such items are estimated at contract inception and updated at the end of each reporting period as additional information becomes available. The amount of variable consideration may be constrained and is included in the transaction price only to the extent it is probable that a significant reversal of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is resolved. Product revenue is recorded after considering the impact of the following variable consideration amounts along with the constraint at the time of revenue recognition: Rebates: The Company’s product is subject to government mandated rebates for Medicaid Drug Rebate Program, Medicare Part D Prescription Drug Benefit Program, and other government health care programs in the United States. Rebate amounts are based upon contractual agreements or legal requirements with public sector benefit providers. The Company uses the expected-value method for estimating these rebates based on statutory discount rates and expected utilization. The expected utilization of rebates is estimated based on expected coverage of identified patients. Estimates for these rebates are adjusted quarterly to reflect the most recent information. The Company records an accrued liability for unpaid rebates related to products for which control has been transferred to a customer. Prompt payment discounts: The Company provides a discount to a customer if it pays for purchases within 30 days. The Company expects that its customers will earn prompt payment discounts and uses the most likely amount method for estimating such discounts. As a result, when revenues are recognized, the Company deducts the full amount of the prompt payment discounts from total product revenues and records these discounts as a reduction of accounts receivable. Co-payment assistance: The Company provides co-payment assistance to patients who have commercial insurance and meet certain eligibility requirements. The Company uses the expected-value method for estimating co-payment assistance based on estimates of program redemption using data provided by third-party administrators. Estimates for the co-payment assistance are adjusted quarterly to reflect actual experience. The Company records an accrued liability for unredeemed co-payment assistance related to products for which control has been transferred to a customer. Product returns: The Company offers limited product return rights and generally allows for the return of product that is damaged or defective, or within a few months prior to and up to a few months after the product expiration date. The Company considers several factors in the estimation of potential product returns, including expiration dates of the product shipped, the limited product return rights, third-party data in monitoring channel inventory levels, shelf life of the product, and other relevant factors. Cost of Sales Cost of sales consists primarily of direct and indirect costs related to the manufacturing of Zokinvy for commercial sale, including third-party manufacturing costs, packaging services, freight, storage costs, and write down of inventories. Accrued Research and Development Costs The Company accrues for estimated costs of research and development activities conducted by third-party service providers, which include the conduct of preclinical and clinical studies, and contract manufacturing activities. The Company records the estimated costs of research and development activities based upon the estimated amount of services provided but not yet invoiced and includes these costs in accrued liabilities in the accompanying unaudited condensed consolidated balance sheets and within research and development expenses in the accompanying unaudited condensed consolidated statements of operations. The Company accrues for these costs based on factors such as estimates of the work completed and in accordance with agreements established with its third-party service providers. The Company makes judgments and estimates in determining the accrued liabilities balance in each reporting period. As actual costs become known, the Company adjusts its accrued liabilities. Accounting Pronouncements Not Yet Adopted In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326) Codification Improvements to Topic 326, Financial Instruments – Credit Losses, Topic 815, Derivatives and Hedging, and Topic 825, Financial Instruments, Financial Instruments – Credit Losses (Topic 326), to irrevocably elect to measure certain individual financial assets at fair value instead of amortized cost In November 2019, the FASB issued ASU No. 2019-10, Financial Instruments – Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842) defers the effective date for ASU No. 2016-13 for smaller reporting companies to fiscal years beginning after December 15, 2022, including interim periods within those fiscal years. The Company is evaluating the impact of the guidance on its unaudited condensed consolidated financial statements. In March 2020, the FASB issued ASU No. 2020-04, Reference Rate Reform (Topic 848) The pronouncement is effective for all entities as of March 12, 2020 through December 31, 2022. In October 2021, the Company amended its Oxford Loan to replace its floating interest rate with the LIBOR replacement rate (see Note 7). The Company will adopt this standard when LIBOR is discontinued and does not expect the adoption to have a material impact on its unaudited condensed consolidated financial statements. |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 3. Fair Value Measurements Fair value accounting is applied for all financial assets and liabilities that are recognized or disclosed at fair value in the financial statements on a recurring basis (at least annually). As of March 31, 2022 and December 31, 2021 Assets and liabilities recorded at fair value on a recurring basis in the unaudited condensed consolidated balance sheets are categorized based upon the level of judgment associated with the inputs used to measure their fair values. Fair value is defined as the exchange price that would be received for an asset or an exit price that would be paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The authoritative guidance on fair value measurements establishes a three-tier fair value hierarchy for disclosure of fair value measurements as follows: Level 1 : Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date; Level 2 : Inputs are observable, unadjusted quoted prices in active markets for similar assets or liabilities, unadjusted quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the related assets or liabilities; and Level 3 : Unobservable inputs that are significant to the measurement of the fair value of the assets or liabilities that are supported by little or no market data. The Company’s money market funds are classified as Level 1 because they are valued using quoted market prices. The Company’s debt securities consist of available-for-sale securities and are classified as Level 2 because their value is based on valuations using significant inputs derived from or corroborated by observable market data. There were no There were no transfers into or out of Level 3 of the fair value hierarchy during the periods presented. The following tables present the fair value hierarchy for assets and liabilities measured at fair value (in thousands): March 31, 2022 Level 1 Level 2 Level 3 Total Financial assets: Money market funds $ 40,483 $ — $ — $ 40,483 Corporate debt securities — 33,264 — 33,264 Commercial paper — 10,904 — 10,904 U.S. government bonds — 41,987 — 41,987 Total $ 40,483 $ 86,155 $ — $ 126,638 December 31, 2021 Level 1 Level 2 Level 3 Total Financial assets: Money market funds $ 13,520 $ — $ — $ 13,520 Corporate debt securities — 41,511 — 41,511 U.S. government bonds — 42,345 — 42,345 Total $ 13,520 $ 83,856 $ — $ 97,376 There were no financial liabilities as of March 31, 2022 and December 31, 2021 The following tables summarize the estimated value of the Company’s cash equivalents and debt securities and the gross unrealized holding gains and losses (in thousands): March 31, 2022 Amortized cost Unrealized gain Unrealized loss Estimated Fair Value Cash equivalents: Money market funds $ 40,483 $ — $ — $ 40,483 Total cash equivalents $ 40,483 $ — $ — $ 40,483 Debt securities: Corporate debt securities $ 33,461 $ — $ (197 ) $ 33,264 Commercial paper 10,904 — — 10,904 U.S. government bonds 42,312 — (325 ) 41,987 Total debt securities $ 86,677 $ — $ (522 ) $ 86,155 Classified as: Cash equivalents $ 40,483 Short-term debt securities 86,155 $ 126,638 December 31, 2021 Amortized cost Unrealized gain Unrealized loss Estimated Fair Value Cash equivalents: Money market funds $ 13,520 $ — $ — $ 13,520 Total cash equivalents $ 13,520 $ — $ — $ 13,520 Debt securities: Corporate debt securities $ 41,576 $ — $ (65 ) $ 41,511 U.S. government bonds 42,429 — (84 ) 42,345 Total debt securities $ 84,005 $ — $ (149 ) $ 83,856 Classified as: Cash equivalents $ 13,520 Short-term debt securities 66,594 Long-term debt securities 17,262 $ 97,376 The Company periodically reviews the available-for-sale securities for other-than-temporary impairment loss. The Company considers factors such as the duration, severity and the reason for the decline in value, the potential recovery period and its intent to sell. For debt securities, it also considers whether (i) it is more likely than not that the Company will be required to sell the debt securities before recovery of their amortized cost basis, and (ii) the amortized cost basis cannot be recovered as a result of credit losses. During the three months ended March 31, 2022, the Company did not recognize any other-than-temporary impairment losses. All debt securities with unrealized losses have been in a loss position for less than 12 months. |
Balance Sheet Components
Balance Sheet Components | 3 Months Ended |
Mar. 31, 2022 | |
Balance Sheet Related Disclosures [Abstract] | |
Balance Sheet Components | 4. Balance Sheet Components Inventories Inventories consist of the following (in thousands): March 31, December 31, 2022 2021 Raw materials $ 1,056 $ 1,056 Work-in-progress 781 1,468 Finished goods 73 88 Total inventories $ 1,910 $ 2,612 Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consist of the following (in thousands): March 31, December 31, 2022 2021 Prepaid contract manufacturing costs $ 4,429 $ 3,695 Prepaid research costs 3,850 3,253 Prepaid insurance 163 631 Other 2,000 1,782 Total prepaid expenses and other current assets $ 10,442 $ 9,361 Accrued Liabilities Accrued liabilities consist of the following (in thousands): March 31, December 31, 2022 2021 Contract research costs $ 8,801 $ 4,760 Product revenue reserves 2,005 1,846 Compensation and related benefits 1,583 3,131 Contract manufacturing costs 929 3,288 Other 937 674 Total accrued liabilities $ 14,255 $ 13,699 |
Bristol-Meyers Squibb License A
Bristol-Meyers Squibb License Agreement | 3 Months Ended |
Mar. 31, 2022 | |
Product Development Agreement [Abstract] | |
Bristol-Meyers Squibb License Agreement | 5 . Bristol-Meyers Squibb License Agreement On April 20, 2016, the Company and Bristol-Myers Squibb Company (BMS) entered into a License Agreement (the BMS License Agreement) and a Common Stock Purchase Agreement (the BMS Purchase Agreement). Under the BMS License Agreement, BMS granted the Company an exclusive, worldwide, license to research, develop, manufacture, and sell products containing PEG-interferon Lambda-1a (the Licensed Product) for all therapeutic and diagnostic uses in humans and animals. The Company is responsible for the development and commercialization of the Licensed Product at its sole cost and expense. The Company paid BMS $2.0 million and issued 157,587 shares of its common stock at an aggregate fair value of $3.2 million in April 2016. The BMS License Agreement also includes development and regulatory milestone payments totaling $61.0 million and commercial sales milestones of up to $128.0 million. The Company is obligated to pay BMS annual net sales royalties in the range of mid-single to mid-teens, depending on net sales levels. In fourth quarter of 2020, the Company recorded in research and development expense a $3.0 million milestone, triggered on successful demonstration of proof of concept, as defined by the BMS License Agreement, in a Phase 2 clinical trial. In March 2022, the Company recorded a $ 5.0 million milestone expense i n research and development , which was related to the initiation of a Phase 3 clinical trial, as defined under the BMS License Agreement. |
Asset Purchase Agreements
Asset Purchase Agreements | 3 Months Ended |
Mar. 31, 2022 | |
Asset Purchase Agreements [Abstract] | |
Asset Purchase Agreements | 6 . Asset Purchase Agreements On November 20, 2020, Eiger entered into an asset purchase agreement (the APA) with AbbVie, Inc. (AbbVie) to sell its rare pediatric disease priority review voucher (the PRV), which was awarded on November 20, 2020 upon FDA approval of Zokinvy. The APA contains customary representations, warranties, covenants, and indemnification provisions subject to certain limitations. In consideration for the PRV, AbbVie agreed to pay the Company $95.0 million. The transaction closed in January 2021. Such consideration was shared with the Progeria Research Foundation (PRF) in accordance with the terms of the PRF Collaboration and Supply Agreement, pursuant to which the Company and PRF will equally share any net proceeds from the sale of a priority review voucher that the Company may receive as the sponsor of a rare pediatric disease product application. The Company retained $46.5 million of proceeds from the sale of the PRV, net of related payments, and recorded the amount in other income, net in the unaudited condensed consolidated statement of operations for the three months ended March 31, 2021. |
Debt
Debt | 3 Months Ended |
Mar. 31, 2022 | |
Debt Disclosure [Abstract] | |
Debt | 7. Debt In December 2016, the Company entered into an aggregate $25.0 million loan with Oxford Finance LLC (the Oxford Loan) with a maturity date of July 1, 2021. The Company borrowed $15.0 million in December 2016 (Tranche A). In May 2018, the Company entered into an amendment to the Oxford Loan and borrowed $5.0 million (Tranche B). On August 3, 2018, the Company On March 5, 2019, the Company entered into the third amendment to the Oxford Loan (the Amended Oxford Loan) to refinance the Oxford Loan. The Amended Oxford Loan increased the aggregate amount available to be borrowed to $35.0 million and extended the maturity date to March 1, 2024. On March 5, 2019, prior to entering into the Amended Oxford Loan, the outstanding balance of the Oxford Loan was $23.3 million. At the time of entering into the Amended Oxford Loan, the Company borrowed an additional $6.7 million in principal under the Amended Oxford Loan, which increased the total amount borrowed to $30.0 million (Amended Tranche A). The remaining $5.0 million (Amended Tranche B) was available to the Company provided that certain milestones are achieved by February 2021. The Company did not draw down the Amended Tranche B. On February 23, 2021, the Company entered into the fifth amendment to the Oxford Loan. The amendment extended the interest only period by 17 months until September 1, 2022, followed by 19 equal monthly payments of principal and interest. Upon the receipt of the Amended Tranche B, the interest only period for borrowed funds will be extended by six months until March 1, 2023, followed by 13 equal monthly payments of principal plus accrued interest. In addition, the Company paid an amendment fee of $0.2 million to the lender on the effective date of the fifth amendment, which was recorded as an additional debt discount and is being amortized over the remaining term of the Amended Oxford Loan. The Amended Tranche B is now available to the Company provided certain milestones are achieved by August 2022. On October 6, 2021, the Company entered into the sixth amendment to the Oxford Loan. Prior to the sixth amendment, the Amended Oxford Loan bore interest at a floating rate per annum equal to the greater of either the 30-day U.S. Dollar LIBOR reported in the Wall Street Journal plus 6.64% or 9.15%. The latest amendment replaces this rate with the LIBOR replacement rate upon a LIBOR transition event. As a result, the Amended Oxford Loan will bear interest at the LIBOR replacement rate which is the sum of the alternate benchmark rate and the LIBOR replacement spread . At the time of final payment, the Company is required to pay an exit fee of 7.5% of the original principal balance of borrowed funds, or $2.3 million. In addition, the Company is required to pay an additional exit fee of $1.0 million The Company is also required to pay a 5.0% success fee of the total amount drawn under the Amended Oxford Loan The Amended Oxford Loan includes contingent interest features and mandatory prepayment features upon an event of default that meet the definition of a derivative but were not bifurcated from the debt instrument as their fair value was deemed to be insignificant . The refinancing of the Oxford Loan did not have a material impact on terms, conditions, representations, warranties, covenants or agreements set forth in the Oxford Loan. The loan is secured by the perfected first priority liens on the Company's assets, including a commitment by the Company to not allow any liens to be placed upon the Company’s intellectual property. The loan includes customary events of default, including failure to pay amounts due, breaches of covenants and warranties, material adverse effect events, certain cross defaults and judgments, and insolvency. As of March 31, 2022, the Company was in compliance with all covenants. The Company is permitted to make voluntary prepayments of the Amended Oxford Loan with a prepayment fee, calculated as of the loan origination date, equal to (i) 2.0% of the loan prepaid during the first 12 months and (ii) 1.0% of the loan prepaid in months 13-24. The Company is required to make mandatory prepayments of the outstanding loan upon the acceleration by lender following the occurrence of an event of default, along with a payment of the final payment, the prepayment fee and any other obligations that are due and payable at the time of prepayment. The Company accounts for the amortization of the debt discount utilizing the effective interest method. Long-term debt and unamortized discount balances are as follows (in thousands): March 31, December 31, 2022 2021 Face value of long-term debt $ 30,000 $ 30,000 Exit fee 3,277 3,277 Unamortized debt discount associated with exit fee, debt issuance costs and loan origination fees (1,282 ) (1,482 ) Total long-term debt, net 31,995 31,795 Less: current portion of long-term debt (12,549 ) (7,809 ) long-term debt, net $ 19,446 $ 23,986 |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2022 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-Based Compensation | 8 . Stock-Based Compensation During the second quarter of 2021, the Company approved the 2021 Inducement Plan to reserve 850,000 shares of its common stock to be used exclusively for grants of awards to individuals that were not previously employees or directors of the Company as a material inducement to such individuals’ entry into employment with the Company within the meaning of Rule 5635(c)(4) of the Nasdaq Listing Rules. As of March 31, 2022, there were 670,000 shares remaining available to be issued under the 2021 Inducement Plan. The following table summarizes stock option activity under the Company’s stock-based compensation plan during the three months ended March 31, 2022 (in thousands, except option and share data): Shares Available for Grant Number of Options Weighted- Average Exercise Price Weighted- Average Remaining Contractual Life (in Years) Aggregate Intrinsic Value Outstanding as of December 31, 2021 1,327,645 5,262,185 $ 10.24 7.25 $ 530 Additional shares authorized 1,728,441 — Granted (1,353,300 ) 1,353,300 $ 5.17 Restricted stock units granted (298,150 ) — Exercised — (15,995 ) $ 8.98 Forfeited or cancelled 109,039 (109,039 ) $ 12.06 Restricted stock units forfeited 33,225 — Outstanding as of March 31, 2022 1,546,900 6,490,451 $ 9.16 7.75 $ 7,636 Vested and exercisable as of March 31, 2022 3,115,184 $ 11.07 6.22 $ 1,934 During the three months ended March 31, 2022 and 2021, the weighted-average grant date fair value of options granted were $3.23 and $7.76 per share, respectively. The Company records stock-based compensation of stock options granted by estimating the fair value of stock-based awards using the Black-Scholes option pricing model and amortizes the fair value of the stock-based awards granted over the applicable vesting period of the awards on a straight-line basis. The fair value of stock options was estimated using the following weighted-average assumptions: Three Months Ended March 31, 2022 2021 Expected term (in years) 5.27-6.08 5.27-6.08 Volatility 68.71%-70.75% 72.39%-100.87% Risk free interest rate 1.76%-2.41% 0.62%-1.16% Dividend yield — — Restricted Stock Units and Performance Stock Units In the first quarter of 2020, the Company revised its non-employee director compensation policy to approve the granting of restricted stock units (RSUs) in accordance with the Restated 2013 Equity Incentive Plan (the Restated 2013 Plan). Each eligible director who has served for at least six months during the prior calendar year and continues to serve as a non-employee member of the Board of Directors (the “Board”) is granted RSUs. Each eligible director who has served on the Board for less than six months during the prior calendar year and who continues to serve as a non-employee member of the Board, is granted RSUs which are pro-rated for the period served during the prior calendar year. The RSUs granted to non-employee directors will vest on the one-year anniversary of the grant date, subject to the eligible director’s continuous services through the vesting date, and will vest in full upon a change in control, as defined under the Restated 2013 Plan. The RSUs granted to employees will vest annually on the one-year, two-year, and three-year anniversaries of the grant date. The fair value of all RSUs is measured at the grant date based on the closing market price of the Company’s common stock and is recognized as stock-based compensation expense on a straight-line basis over the vesting period. The performance stock units (PSUs) are also available for grant pursuant to the Restated 2013 Plan. Each PSU, which is a stock award, is earned through the achievement of performance-based metrics over a defined performance period. The length of the defined performance period, the performance-based metric to be achieved during the defined performance period, and the measure of whether and to what degree such performance-based metric has been achieved will be conclusively determined by the compensation committee of the Company’s board of directors, in its sole discretion. The estimated fair value of equity awards that contain performance conditions is expensed over the term of the award once the Company has determined that it is probable that performance conditions will be satisfied. There was no PSUs granted during the three months ended March 31, 2022. As of March 31, 2022, no PSUs have vested as the performance-based metrics of the PSUs have not yet been achieved. During the three months ended March 31, 2022 and 2021, the Company granted 298,150 and 203,500 RSUs, respectively, with a weighted-average grant date fair value of $5.22 and $9.99 per share, respectively. In relation to the RSUs granted, the Company recognized $0.4 million and $0.1 million in stock-based compensation expense for the three months ended March 31, 2022 and 2021, respectively, which were included in selling, general and administrative expenses. As of March 31, 2022, the total unrecognized compensation expense related to unvested RSUs and PSUs was $5.1 million, which the Company expects to recognize over an estimated weighted-average period of 2.7 years. The following table summarizes RSU and PSU activity and weighted average grant date fair value for the three months ended March 31, 2022: Shares Weighted- Average Grant Date Fair Value Unvested shares as of December 31, 2021 623,000 $ 8.63 Granted 298,150 $ 5.22 Vested (85,106 ) $ 10.09 Forfeited (33,225 ) $ 8.33 Unvested shares as of March 31, 2022 802,819 $ 7.22 Stock-Based Compensation Expense Total stock-based compensation expense recognized was as follows (in thousands): Three Months Ended March 31, 2022 2021 Research and development $ 625 $ 391 Selling, general and administrative 1,422 1,158 Total $ 2,047 $ 1,549 As of March 31, 2022, the total unrecognized compensation expense related to unvested options was $15.2 million, which the Company expects to recognize over an estimated weighted average period of 2.9 years. |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 9 . Income Taxes The Company’s provision for income taxes was $9,000 and $19,000 for the three months ended March 31, 2022 and 2021, with an effective tax rate of 0.04% and 0.1% for the three months ended March 31, 2022 and 2021, respectively. The effective tax rate in each period differs from the U.S. statutory tax rate primarily due to the valuation allowances on the Company’s deferred tax assets as it is more likely than not that some or all of the Company’s deferred tax assets will not be realized. The tax expense recorded for the three months ended March 31, 2022 and March 31, 2021, respectively, relates to state taxes. |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2022 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 10 . Commitments and Contingencies Lease Agreements In October 2017, the Company entered into a non-cancelable operating facility lease agreement for 8,029 square feet of office space located at 2155 Park Blvd. in Palo Alto, California. The lease commenced on March 1, 2018 and expires in February 2023. The lease has a three-year The maturity of the Company’s operating lease liabilities as of March 31, 2022, were as follows (in thousands): Undiscounted lease payments March 31, 2022 Remaining in 2022 501 2023 115 2024 1 2025 1 Total undiscounted payments 618 Less: imputed interest 24 Present value of future lease payments 594 Less: current portion of operating lease liabilities 590 Operating lease liabilities $ 4 Rent expense recognized for the Company’s operating leases was $0.1 million and $0.2 million for the three months ended March 31, 2022 and 2021, respectively. Under the terms of the lease agreements, the Company is also responsible for certain variable lease payments that are not included in the measurement of the lease liability. Variable lease payments for the operating leases was $23,000 for each of the three months ended March 31, 2022 and 2021. The operating cash outflows for the operating lease liabilities were $0.2 million and $0.2 million for the three months ended March 31, 2022 and 2021, respectively. As of March 31, 2022 and December 31, 2021, the weighted-average remaining lease terms were 0.9 years and 1.2 years, and weighted-average discount rates were 9.15% and 9.15%, respectively. |
Net Income (Loss) Per Share
Net Income (Loss) Per Share | 3 Months Ended |
Mar. 31, 2022 | |
Earnings Per Share [Abstract] | |
Net (Loss) Income Per Share | 1 1 . Net (Loss) Income Per Share Basic net loss per share of common stock is calculated by dividing the net loss by the weighted average number of shares of common stock outstanding during the period, without consideration for potentially dilutive securities. Since the Company was in a loss position for the three months ended March 31, 2022, diluted net loss per share is the same as basic net loss per share as the inclusion of all potential common shares outstanding would have been anti-dilutive. Diluted net income per share for the three months ended March 31, 2021 is computed by dividing net income by the weighted-average number of shares of common stock and dilutive potential common stock equivalents then outstanding. Dilutive potential common stock equivalents include the assumed exercise, vesting and issuance of employee stock awards using the treasury stock method. The following table sets forth the computation of basic and diluted net (loss) income per common share for the periods presented (in thousands, except share amounts): Three Months Ended March 31, 2022 2021 Numerator: Net (loss) income $ (22,643 ) $ 29,248 Denominator: Weighted-average shares outstanding for basic net (loss) income per share 35,253,147 33,886,896 Effect of dilutive securities — 333,999 Weighted-average shares outstanding for diluted net (loss) income per share 35,253,147 34,220,895 Net (loss) income per share: Basic $ (0.64 ) $ 0.86 Diluted $ (0.64 ) $ 0.85 The following table sets forth the outstanding potentially dilutive securities which have been excluded in the calculation of diluted net (loss) income per share because including such securities would be anti-dilutive (in common stock equivalent shares): Three Months Ended March 31, 2022 2021 Options to purchase common stock 6,490,451 2,895,223 Restricted stock units (unvested) 802,819 — ESPP 87,553 3,789 Total 7,380,823 2,899,012 |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2022 | |
Subsequent Events [Abstract] | |
Subsequent Events | 1 2 . Subsequent Event On March 25, 2022, the Company entered into a new Open Market Sale Agreement SM . |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The unaudited condensed consolidated financial statements include the accounts of Eiger BioPharmaceuticals, Inc. and its wholly owned subsidiaries, EBPI Merger Inc., EB Pharma LLC, Eiger BioPharmaceuticals Europe Limited, and EigerBio Europe Limited, have been prepared in accordance with accounting principles generally accepted in the United States of America, (U.S. GAAP) and follow the requirements of the Securities and Exchange Commission (the “SEC”) for annual reporting. All intercompany balances and transactions have been eliminated in consolidation. |
Use of Estimates | Use of Estimates The preparation of unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. On an ongoing basis, the Company evaluates its estimates. The Company bases its estimates on historical experience and on various other market-specific and relevant assumptions that the Company believes to be reasonable under the circumstances. Actual results could differ from those estimates. |
Debt Securities | Debt Securities Short-term securities consist of debt securities classified as available-for-sale and have maturities greater than 90 days, but less than 365 days from the date of acquisition. Long-term securities consist of debt securities classified as available-for-sale and have maturities greater than 365 days from the date of acquisition. All short-term and long-term securities are carried at fair value based upon quoted market prices. Unrealized gains and losses on available-for-sale securities are excluded from earnings and are reported as a component of accumulated other comprehensive (loss) income. The cost of available-for-sale securities sold is based on the specific-identification method . |
Accounts Receivable | Accounts Receivable Accounts receivable represent amounts billed to the Company’s customers, net of an allowance for doubtful accounts. Trade accounts receivable are recorded at invoiced amounts and do not bear interest. The expectation of collectability is based on a review of credit profiles of customers, contractual terms and conditions, current economic trends, and historical payment experience. The Company regularly reviews the adequacy of the allowance for doubtful accounts by considering the age of each outstanding invoice and the collection history of each customer to determine the appropriate amount of allowance for doubtful accounts. The Company had no allowance as of March 31, 2022 and 2021. The Company had no bad debt expense for the three months ended March 31, 2022 and 2021. |
Inventories | Inventories Inventories are stated at the lower of cost, determined based on actual costs, or estimated net realizable value, on a first-in, first-out basis. Inventories consist of raw materials, work-in-process, and finished goods. Prior to regulatory approval of the Company’s product candidates, expenses incurred to manufacture drug products are recorded as research and development expense. The Company begins capitalizing these expenses as inventory upon regulatory approval. The Company periodically assesses the recoverability of its inventory and reduces the carrying value of the inventory when items are determined to be obsolete, defective or in excess of forecasted sales requirements. Inventory write-downs for excess, defective, and obsolete inventory are recorded as a cost of sales. There have been no write-downs of inventories for the periods presented. |
Revenue Recognition | Revenue Recognition The Company recognizes revenue upon transfer of control of promised products to customers in an amount that reflects the consideration it expects to receive in exchange for those products. Product Revenue The Company’s product revenue consists of sales of Zokinvy, which received FDA approval in November 2020 and was launched commercially in the United States in January 2021. Prior to 2021, the Company had no product revenue. In the United States, the Company sells Zokinvy to a single specialty pharmacy provider that subsequently dispenses the product directly to patients. The Company discloses revenue on a total basis without further disaggregation. Additionally, the Company does not have any contract assets or liabilities, other than accounts receivable, related to its product revenue. In June 2021, the French National Agency for Medicines and Health Products Safety (ANSM) granted Zokinvy (lonafarnib) a Temporary Authorizations for Use (Autorisation Temporaire d'Utilisation or ATU) for an early access program for a term of one year. In the context of this program, the Company sells product to a distributor who in turn ships product to pharmacies after receiving requests from physicians for patients in France. In November 2021, the Company began distributing and recognizing revenue from sales of Zokinvy (lonafarnib) through a reimbursed early access program in France. There was no revenue from sale of product under the ATU program for the three months ended March 31, 2022. The Company recognizes product revenue when a customer obtains control of its product, which occurs at a point in time, typically upon delivery to a customer as the delivery of the product is the Company’s only performance obligation. Shipping and handling activities are fulfillment activities rather than a separate performance obligation and are recorded in cost of sales. Product revenue is recorded at the net sales price (transaction price), which includes estimates of variable consideration resulting from rebates, prompt payment discounts, co-payment assistance, and returns. Amounts related to such items are estimated at contract inception and updated at the end of each reporting period as additional information becomes available. The amount of variable consideration may be constrained and is included in the transaction price only to the extent it is probable that a significant reversal of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is resolved. Product revenue is recorded after considering the impact of the following variable consideration amounts along with the constraint at the time of revenue recognition: Rebates: The Company’s product is subject to government mandated rebates for Medicaid Drug Rebate Program, Medicare Part D Prescription Drug Benefit Program, and other government health care programs in the United States. Rebate amounts are based upon contractual agreements or legal requirements with public sector benefit providers. The Company uses the expected-value method for estimating these rebates based on statutory discount rates and expected utilization. The expected utilization of rebates is estimated based on expected coverage of identified patients. Estimates for these rebates are adjusted quarterly to reflect the most recent information. The Company records an accrued liability for unpaid rebates related to products for which control has been transferred to a customer. Prompt payment discounts: The Company provides a discount to a customer if it pays for purchases within 30 days. The Company expects that its customers will earn prompt payment discounts and uses the most likely amount method for estimating such discounts. As a result, when revenues are recognized, the Company deducts the full amount of the prompt payment discounts from total product revenues and records these discounts as a reduction of accounts receivable. Co-payment assistance: The Company provides co-payment assistance to patients who have commercial insurance and meet certain eligibility requirements. The Company uses the expected-value method for estimating co-payment assistance based on estimates of program redemption using data provided by third-party administrators. Estimates for the co-payment assistance are adjusted quarterly to reflect actual experience. The Company records an accrued liability for unredeemed co-payment assistance related to products for which control has been transferred to a customer. Product returns: The Company offers limited product return rights and generally allows for the return of product that is damaged or defective, or within a few months prior to and up to a few months after the product expiration date. The Company considers several factors in the estimation of potential product returns, including expiration dates of the product shipped, the limited product return rights, third-party data in monitoring channel inventory levels, shelf life of the product, and other relevant factors. |
Cost of Sales | Cost of Sales Cost of sales consists primarily of direct and indirect costs related to the manufacturing of Zokinvy for commercial sale, including third-party manufacturing costs, packaging services, freight, storage costs, and write down of inventories. |
Accrued Research and Development Costs | Accrued Research and Development Costs The Company accrues for estimated costs of research and development activities conducted by third-party service providers, which include the conduct of preclinical and clinical studies, and contract manufacturing activities. The Company records the estimated costs of research and development activities based upon the estimated amount of services provided but not yet invoiced and includes these costs in accrued liabilities in the accompanying unaudited condensed consolidated balance sheets and within research and development expenses in the accompanying unaudited condensed consolidated statements of operations. The Company accrues for these costs based on factors such as estimates of the work completed and in accordance with agreements established with its third-party service providers. The Company makes judgments and estimates in determining the accrued liabilities balance in each reporting period. As actual costs become known, the Company adjusts its accrued liabilities. |
Accounting Pronouncements Not Yet Adopted | Accounting Pronouncements Not Yet Adopted In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326) Codification Improvements to Topic 326, Financial Instruments – Credit Losses, Topic 815, Derivatives and Hedging, and Topic 825, Financial Instruments, Financial Instruments – Credit Losses (Topic 326), to irrevocably elect to measure certain individual financial assets at fair value instead of amortized cost In November 2019, the FASB issued ASU No. 2019-10, Financial Instruments – Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842) defers the effective date for ASU No. 2016-13 for smaller reporting companies to fiscal years beginning after December 15, 2022, including interim periods within those fiscal years. The Company is evaluating the impact of the guidance on its unaudited condensed consolidated financial statements. In March 2020, the FASB issued ASU No. 2020-04, Reference Rate Reform (Topic 848) The pronouncement is effective for all entities as of March 12, 2020 through December 31, 2022. In October 2021, the Company amended its Oxford Loan to replace its floating interest rate with the LIBOR replacement rate (see Note 7). The Company will adopt this standard when LIBOR is discontinued and does not expect the adoption to have a material impact on its unaudited condensed consolidated financial statements. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
Summary of Assets and Liabilities Measured at Fair Value | The following tables present the fair value hierarchy for assets and liabilities measured at fair value (in thousands): March 31, 2022 Level 1 Level 2 Level 3 Total Financial assets: Money market funds $ 40,483 $ — $ — $ 40,483 Corporate debt securities — 33,264 — 33,264 Commercial paper — 10,904 — 10,904 U.S. government bonds — 41,987 — 41,987 Total $ 40,483 $ 86,155 $ — $ 126,638 December 31, 2021 Level 1 Level 2 Level 3 Total Financial assets: Money market funds $ 13,520 $ — $ — $ 13,520 Corporate debt securities — 41,511 — 41,511 U.S. government bonds — 42,345 — 42,345 Total $ 13,520 $ 83,856 $ — $ 97,376 |
Summary of Estimated Value of Cash Equivalents and Debt Securities and Gross Unrealized Holding Gains and Losses | The following tables summarize the estimated value of the Company’s cash equivalents and debt securities and the gross unrealized holding gains and losses (in thousands): March 31, 2022 Amortized cost Unrealized gain Unrealized loss Estimated Fair Value Cash equivalents: Money market funds $ 40,483 $ — $ — $ 40,483 Total cash equivalents $ 40,483 $ — $ — $ 40,483 Debt securities: Corporate debt securities $ 33,461 $ — $ (197 ) $ 33,264 Commercial paper 10,904 — — 10,904 U.S. government bonds 42,312 — (325 ) 41,987 Total debt securities $ 86,677 $ — $ (522 ) $ 86,155 Classified as: Cash equivalents $ 40,483 Short-term debt securities 86,155 $ 126,638 December 31, 2021 Amortized cost Unrealized gain Unrealized loss Estimated Fair Value Cash equivalents: Money market funds $ 13,520 $ — $ — $ 13,520 Total cash equivalents $ 13,520 $ — $ — $ 13,520 Debt securities: Corporate debt securities $ 41,576 $ — $ (65 ) $ 41,511 U.S. government bonds 42,429 — (84 ) 42,345 Total debt securities $ 84,005 $ — $ (149 ) $ 83,856 Classified as: Cash equivalents $ 13,520 Short-term debt securities 66,594 Long-term debt securities 17,262 $ 97,376 |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Balance Sheet Related Disclosures [Abstract] | |
Schedule of Inventory | Inventories consist of the following (in thousands): March 31, December 31, 2022 2021 Raw materials $ 1,056 $ 1,056 Work-in-progress 781 1,468 Finished goods 73 88 Total inventories $ 1,910 $ 2,612 |
Schedule of Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets consist of the following (in thousands): March 31, December 31, 2022 2021 Prepaid contract manufacturing costs $ 4,429 $ 3,695 Prepaid research costs 3,850 3,253 Prepaid insurance 163 631 Other 2,000 1,782 Total prepaid expenses and other current assets $ 10,442 $ 9,361 |
Schedule of Components of Accrued Liabilities | Accrued liabilities consist of the following (in thousands): March 31, December 31, 2022 2021 Contract research costs $ 8,801 $ 4,760 Product revenue reserves 2,005 1,846 Compensation and related benefits 1,583 3,131 Contract manufacturing costs 929 3,288 Other 937 674 Total accrued liabilities $ 14,255 $ 13,699 |
Debt (Tables)
Debt (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Debt Disclosure [Abstract] | |
Schedule of Long-Term Debt and Unamortized Discount Balances | Long-term debt and unamortized discount balances are as follows (in thousands): March 31, December 31, 2022 2021 Face value of long-term debt $ 30,000 $ 30,000 Exit fee 3,277 3,277 Unamortized debt discount associated with exit fee, debt issuance costs and loan origination fees (1,282 ) (1,482 ) Total long-term debt, net 31,995 31,795 Less: current portion of long-term debt (12,549 ) (7,809 ) long-term debt, net $ 19,446 $ 23,986 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Stock Option Activity | The following table summarizes stock option activity under the Company’s stock-based compensation plan during the three months ended March 31, 2022 (in thousands, except option and share data): Shares Available for Grant Number of Options Weighted- Average Exercise Price Weighted- Average Remaining Contractual Life (in Years) Aggregate Intrinsic Value Outstanding as of December 31, 2021 1,327,645 5,262,185 $ 10.24 7.25 $ 530 Additional shares authorized 1,728,441 — Granted (1,353,300 ) 1,353,300 $ 5.17 Restricted stock units granted (298,150 ) — Exercised — (15,995 ) $ 8.98 Forfeited or cancelled 109,039 (109,039 ) $ 12.06 Restricted stock units forfeited 33,225 — Outstanding as of March 31, 2022 1,546,900 6,490,451 $ 9.16 7.75 $ 7,636 Vested and exercisable as of March 31, 2022 3,115,184 $ 11.07 6.22 $ 1,934 |
Summary of Non-cash Stock Based Compensation Expense | Total stock-based compensation expense recognized was as follows (in thousands): Three Months Ended March 31, 2022 2021 Research and development $ 625 $ 391 Selling, general and administrative 1,422 1,158 Total $ 2,047 $ 1,549 |
Employees and Non Employees Stock Option [Member] | |
Weighted-average assumptions used in Black-Scholes Model to estimate fair value of stock options granted | The fair value of stock options was estimated using the following weighted-average assumptions: Three Months Ended March 31, 2022 2021 Expected term (in years) 5.27-6.08 5.27-6.08 Volatility 68.71%-70.75% 72.39%-100.87% Risk free interest rate 1.76%-2.41% 0.62%-1.16% Dividend yield — — |
Restricted Stock Units (RSU) [Member] | |
Schedule of Nonvested Restricted Stock Units Activity and Weighted Average Grant Date Fair Value | The following table summarizes RSU and PSU activity and weighted average grant date fair value for the three months ended March 31, 2022: Shares Weighted- Average Grant Date Fair Value Unvested shares as of December 31, 2021 623,000 $ 8.63 Granted 298,150 $ 5.22 Vested (85,106 ) $ 10.09 Forfeited (33,225 ) $ 8.33 Unvested shares as of March 31, 2022 802,819 $ 7.22 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Commitments And Contingencies Disclosure [Abstract] | |
Maturity of Operating Leases Liabilities and Future Minimum Lease Payments | The maturity of the Company’s operating lease liabilities as of March 31, 2022, were as follows (in thousands): Undiscounted lease payments March 31, 2022 Remaining in 2022 501 2023 115 2024 1 2025 1 Total undiscounted payments 618 Less: imputed interest 24 Present value of future lease payments 594 Less: current portion of operating lease liabilities 590 Operating lease liabilities $ 4 |
Net (Loss) Income Per Share (Ta
Net (Loss) Income Per Share (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Earnings Per Share [Abstract] | |
Schedule of Computation of Basic and Diluted Net (Loss) Income Per Common Share | The following table sets forth the computation of basic and diluted net (loss) income per common share for the periods presented (in thousands, except share amounts): Three Months Ended March 31, 2022 2021 Numerator: Net (loss) income $ (22,643 ) $ 29,248 Denominator: Weighted-average shares outstanding for basic net (loss) income per share 35,253,147 33,886,896 Effect of dilutive securities — 333,999 Weighted-average shares outstanding for diluted net (loss) income per share 35,253,147 34,220,895 Net (loss) income per share: Basic $ (0.64 ) $ 0.86 Diluted $ (0.64 ) $ 0.85 |
Summary of Potentially Dilutive Shares Excluded from Computation of Diluted Net (Loss) Income Per Share | The following table sets forth the outstanding potentially dilutive securities which have been excluded in the calculation of diluted net (loss) income per share because including such securities would be anti-dilutive (in common stock equivalent shares): Three Months Ended March 31, 2022 2021 Options to purchase common stock 6,490,451 2,895,223 Restricted stock units (unvested) 802,819 — ESPP 87,553 3,789 Total 7,380,823 2,899,012 |
Description of Business - Addit
Description of Business - Additional Information (Detail) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022USD ($)Segment | Dec. 31, 2021USD ($) | |
Description Of Business [Abstract] | ||
Entity incorporation, date of incorporation | Nov. 6, 2008 | |
Number of operating segments | Segment | 1 | |
Cash, Cash Equivalents, and Investments | $ 132,700 | |
Cash and cash equivalents | 46,562 | $ 22,221 |
Debt securities, available-for-sale | 86,100 | |
Accumulated deficit | $ (363,060) | $ (340,417) |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Detail) - USD ($) | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Significant Accounting Policies [Line Items] | ||
Accounts receivable, allowance for doubtful accounts | $ 0 | $ 0 |
Bad debt expense | 0 | 0 |
Inventory Write-down | 0 | |
Revenues from sale of product | 2,673,000 | $ 3,646,000 |
ATU [Member] | ||
Significant Accounting Policies [Line Items] | ||
Revenues from sale of product | $ 0 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) - USD ($) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2022 | Dec. 31, 2021 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets | $ 126,638,000 | $ 97,376,000 |
Financial liabilities | 0 | 0 |
Level 3 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets | 0 | 0 |
Financial liabilities | 0 | 0 |
Transfers in or out of level 3 | $ 0 | $ 0 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Assets and Liabilities Measured at Fair Value (Detail) - USD ($) | Mar. 31, 2022 | Dec. 31, 2021 |
Financial assets: | ||
Assets, Fair Value | $ 126,638,000 | $ 97,376,000 |
Corporate Debt Securities [Member] | ||
Financial assets: | ||
Assets, Fair Value | 33,264,000 | 41,511,000 |
US Government Bonds [Member] | ||
Financial assets: | ||
Assets, Fair Value | 41,987,000 | 42,345,000 |
Money Market Funds [Member] | ||
Financial assets: | ||
Assets, Fair Value | 40,483,000 | 13,520,000 |
Commercial Paper [Member] | ||
Financial assets: | ||
Assets, Fair Value | 10,904,000 | |
Level 1 [Member] | ||
Financial assets: | ||
Assets, Fair Value | 40,483,000 | 13,520,000 |
Level 1 [Member] | Money Market Funds [Member] | ||
Financial assets: | ||
Assets, Fair Value | 40,483,000 | 13,520,000 |
Level 2 [Member] | ||
Financial assets: | ||
Assets, Fair Value | 86,155,000 | 83,856,000 |
Level 2 [Member] | Corporate Debt Securities [Member] | ||
Financial assets: | ||
Assets, Fair Value | 33,264,000 | 41,511,000 |
Level 2 [Member] | US Government Bonds [Member] | ||
Financial assets: | ||
Assets, Fair Value | 41,987,000 | 42,345,000 |
Level 2 [Member] | Commercial Paper [Member] | ||
Financial assets: | ||
Assets, Fair Value | 10,904,000 | |
Level 3 [Member] | ||
Financial assets: | ||
Assets, Fair Value | $ 0 | $ 0 |
Fair Value Measurements - Estim
Fair Value Measurements - Estimated Value of Cash Equivalents and Debt Securities and Gross Unrealized Holding Gains and Losses (Detail) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Cash Equivalents and Investment Securities [Line Items] | ||
Cash equivalents, Amortized cost | $ 40,483 | $ 13,520 |
Cash equivalents, Estimated Fair Value | 40,483 | |
Debt securities, Amortized cost | 86,677 | 84,005 |
Debt securities, Unrealized loss | (522) | (149) |
Debt securities, Estimated Fair Value | 86,155 | 83,856 |
Assets, Fair Value | 126,638 | 97,376 |
Short-Term Debt [Member] | ||
Cash Equivalents and Investment Securities [Line Items] | ||
Debt securities, Estimated Fair Value | 86,155 | 66,594 |
Long-term Debt | ||
Cash Equivalents and Investment Securities [Line Items] | ||
Debt securities, Estimated Fair Value | 17,262 | |
Corporate Debt Securities [Member] | ||
Cash Equivalents and Investment Securities [Line Items] | ||
Debt securities, Amortized cost | 33,461 | 41,576 |
Debt securities, Unrealized loss | (197) | (65) |
Debt securities, Estimated Fair Value | 33,264 | 41,511 |
Assets, Fair Value | 33,264 | 41,511 |
US Government Bonds [Member] | ||
Cash Equivalents and Investment Securities [Line Items] | ||
Debt securities, Amortized cost | 42,312 | 42,429 |
Debt securities, Unrealized loss | (325) | (84) |
Debt securities, Estimated Fair Value | 41,987 | 42,345 |
Assets, Fair Value | 41,987 | 42,345 |
Money Market Funds [Member] | ||
Cash Equivalents and Investment Securities [Line Items] | ||
Cash equivalents, Amortized cost | 40,483 | 13,520 |
Cash equivalents, Estimated Fair Value | 40,483 | |
Assets, Fair Value | 40,483 | 13,520 |
Commercial Paper [Member] | ||
Cash Equivalents and Investment Securities [Line Items] | ||
Debt securities, Amortized cost | 10,904 | |
Debt securities, Estimated Fair Value | 10,904 | |
Assets, Fair Value | 10,904 | |
Cash Equivalents [Member] | ||
Cash Equivalents and Investment Securities [Line Items] | ||
Cash equivalents, Estimated Fair Value | $ 40,483 | $ 13,520 |
Balance Sheet Components - Sche
Balance Sheet Components - Schedule of Inventory (Detail) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 1,056 | $ 1,056 |
Work-in-progress | 781 | 1,468 |
Finished goods | 73 | 88 |
Total inventories | $ 1,910 | $ 2,612 |
Balance Sheet Components - Sc_2
Balance Sheet Components - Schedule of Prepaid Expenses and Other Current Assets (Detail) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Prepaid Expense And Other Assets Current [Abstract] | ||
Prepaid contract manufacturing costs | $ 4,429 | $ 3,695 |
Prepaid research costs | 3,850 | 3,253 |
Prepaid insurance | 163 | 631 |
Other | 2,000 | 1,782 |
Total prepaid expenses and other current assets | $ 10,442 | $ 9,361 |
Balance Sheet Components - Sc_3
Balance Sheet Components - Schedule of Components of Accrued Liabilities (Detail) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Payables And Accruals [Abstract] | ||
Contract research costs | $ 8,801 | $ 4,760 |
Product revenue reserves | 2,005 | 1,846 |
Compensation and related benefits | 1,583 | 3,131 |
Contract manufacturing costs | 929 | 3,288 |
Other | 937 | 674 |
Total accrued liabilities | $ 14,255 | $ 13,699 |
Bristol-Meyers Squibb License_2
Bristol-Meyers Squibb License Agreement - Additional Information (Detail) - USD ($) $ in Thousands | Apr. 20, 2016 | Mar. 31, 2022 | Dec. 31, 2020 | Dec. 31, 2021 |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Aggregate fair value of shares issued | $ 41 | $ 35 | ||
Common Stock [Member] | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Sale of common stock | 5,841,786 | |||
BMS Transaction [Member] | Licensing Agreements [Member] | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Upfront payment | $ 2,000 | |||
BMS Transaction [Member] | Common Stock [Member] | BMS Purchase Agreement [Member] | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Sale of common stock | 157,587 | |||
Aggregate fair value of shares issued | $ 3,200 | |||
BMS Transaction [Member] | Development and Regulatory Milestones [Member] | Licensing Agreements [Member] | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Milestone payment obligations | 61,000 | |||
BMS Transaction [Member] | Commercial Sales [Member] | Maximum [Member] | Licensing Agreements [Member] | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Milestone payment obligations | $ 128,000 | |||
BMS Transaction [Member] | Development Phase 2 [Member] | Licensing Agreements [Member] | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Milestone payment obligations | $ 3,000 | |||
BMS Transaction [Member] | Development Phase 3 [Member] | Licensing Agreements [Member] | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Milestone payment obligations | $ 5,000 |
Asset Purchase Agreements - Add
Asset Purchase Agreements - Additional Information (Detail) - AbbVie Asset Purchase Agreement [Member] $ in Millions | Nov. 20, 2020USD ($) |
Asset Purchase Agreements [Line Items] | |
Payment for asset purchase agreement | $ 95 |
Progeria Research Foundation (PRF) Collaboration Agreement [Member] | |
Asset Purchase Agreements [Line Items] | |
Proceeds from sale | $ 46.5 |
Debt - Additional Information (
Debt - Additional Information (Detail) - USD ($) $ in Thousands | Oct. 06, 2021 | Feb. 23, 2021 | Mar. 05, 2019 | Dec. 31, 2016 | Mar. 31, 2022 | Dec. 31, 2021 | Aug. 03, 2018 | May 31, 2018 |
Debt Instrument [Line Items] | ||||||||
Face value of term loan | $ 30,000 | $ 30,000 | ||||||
Loan final repayment exit fees payable | $ (3,277) | $ (3,277) | ||||||
Loan agreement, covenant noncompliance penalty | 5.00% | |||||||
Loan agreement, covenant description | The loan includes customary events of default, including failure to pay amounts due, breaches of covenants and warranties, material adverse effect events, certain cross defaults and judgments, and insolvency | |||||||
Loan agreement, covenant compliance | and accelerate the maturity of the debt. | |||||||
Oxford Loan [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Loan agreement, aggregate borrowing capacity | $ 25,000 | |||||||
Loan, maturity period | Jul. 1, 2021 | |||||||
Repayments of loan agreement exit fee | $ 900 | |||||||
Oxford Loan [Member] | Tranche A [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Face value of term loan | $ 15,000 | |||||||
Amendment [Member] | Tranche B [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Face value of term loan | $ 5,000 | |||||||
Amendment [Member] | Tranche C [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Face value of term loan | $ 5,000 | |||||||
Amended Oxford Loan [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Loan agreement, aggregate borrowing capacity | $ 35,000 | |||||||
Loan, maturity period | Mar. 1, 2024 | |||||||
Loan outstanding | 23,300 | |||||||
Borrowings from loan agreement | 6,700 | |||||||
Loan agreement, floating rate terms | floating rate per annum equal to the greater of either the 30-day U.S. Dollar LIBOR reported in the Wall Street Journal plus 6.64% or 9.15% | |||||||
Percentage of exit fee on principal balance | 7.50% | |||||||
Loan final repayment exit fees payable | $ 2,300 | |||||||
Loan final repayment additional exit fees payable | $ 1,000 | |||||||
Prepayment of loan fee, description | calculated as of the loan origination date, equal to (i) 2.0% of the loan prepaid during the first 12 months and (ii) 1.0% of the loan prepaid in months 13-24. | |||||||
Amended Oxford Loan [Member] | Loan Prepaid During First 12 Months [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt instrument prepayment fee percentage | 2.00% | |||||||
Amended Oxford Loan [Member] | Loan Prepaid During 13 to 24 Months [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt instrument prepayment fee percentage | 1.00% | |||||||
Amended Oxford Loan [Member] | Minimum [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Loan agreement, interest rate | 9.15% | |||||||
Amended Oxford Loan [Member] | Food and Drug Administration [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Percentage of success fee | 5.00% | |||||||
Success fees payable maximum period after approval | 30 days | |||||||
Amended Oxford Loan [Member] | LIBOR [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Loan agreement, percentage to be added to the interest rate under condition | 6.64% | |||||||
Amended Oxford Loan [Member] | Amended Tranche A [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Loan agreement, aggregate borrowing capacity | 30,000 | |||||||
Amended Oxford Loan [Member] | Amended Tranche A [Member] | Food and Drug Administration [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Fee payable maximum period from funding | 10 years | |||||||
Amended Oxford Loan [Member] | Amended Tranche B [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Loan agreement, remaining borrowing capacity | $ 5,000 | |||||||
Fifth Amended Oxford Loan [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Principal and interest payment period | 19 years | |||||||
Interest payment period | 17 months | |||||||
Amendment fees payment | $ 200 | |||||||
Fifth Amended Oxford Loan [Member] | Tranche B [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Principal and interest payment period | 13 years | |||||||
Interest payment period | 6 months |
Debt - Schedule of Long-Term De
Debt - Schedule of Long-Term Debt and Unamortized Discount Balances (Detail) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Debt Disclosure [Abstract] | ||
Face value of long-term debt | $ 30,000 | $ 30,000 |
Exit fee | 3,277 | 3,277 |
Unamortized debt discount associated with exit fee, debt issuance costs and loan origination fees | (1,282) | (1,482) |
Total long-term debt, net | 31,995 | 31,795 |
Less: current portion of long-term debt | (12,549) | (7,809) |
Long-term debt, net | $ 19,446 | $ 23,986 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Stock options granted | 1,353,300 | |
Total unrecognized compensation expense | $ 15,200 | |
Weighted average period expected to recognized compensation expense (in years) | 2 years 10 months 24 days | |
Stock-based compensation expense | $ 2,047 | $ 1,549 |
Weighted average period expected to recognized compensation expense (in years) | 2 years 10 months 24 days | |
Employees Stock Option [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Weighted-average grant date fair value of employee option grants | $ 3.23 | $ 7.76 |
Performance Stock Units (PSU) [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Stock options granted | 0 | |
PSUs vested during the period | 0 | |
Restricted Stock Units (RSU) [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Weighted-average grant date fair value of employee option grants | $ 5.22 | $ 9.99 |
Stock options granted | 298,150 | 203,500 |
Weighted average period expected to recognized compensation expense (in years) | 2 years 8 months 12 days | |
Stock-based compensation expense | $ 400 | $ 100 |
Weighted average period expected to recognized compensation expense (in years) | 2 years 8 months 12 days | |
Restricted Stock Units and Performance Stock Unit [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Weighted-average grant date fair value of employee option grants | $ 5.22 | |
Stock options granted | 298,150 | |
Total unrecognized compensation expense | $ 5,100 | |
Inducement Plan 2021 [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Common stock available for grant | 850,000 | |
Number of shares available to be issued | 670,000 |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock Option Activity (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2022 | Dec. 31, 2021 | |
Sharebased Compensation Arrangement By Sharebased Payment Award Options Outstanding Weighted Average Exercise Price And Additional Disclosures [Abstract] | ||
Shares Available for Grant, Outstanding, Beginning balance | 1,327,645 | |
Additional shares authorized | 1,728,441 | |
Shares Available for Grant, Granted | (1,353,300) | |
Shares Available for Grant, Restricted stock units granted | (298,150) | |
Shares Available for Grant, Forfeited or cancelled | 109,039 | |
Restricted stock units forfeited | 33,225 | |
Shares Available for Grant, Outstanding, Ending balance | 1,546,900 | 1,327,645 |
Vested and exercisable as of March 31, 2022 | 3,115,184 | |
Number of Options, Outstanding, Beginning balance | 5,262,185 | |
Number of Options, Granted | 1,353,300 | |
Shares Available for Grant, Restricted stock units granted | 298,150 | |
Number of Options, Exercised | (15,995) | |
Number of Options, Forfeited or cancelled | (109,039) | |
Number of Options, Outstanding, Ending balance | 6,490,451 | 5,262,185 |
Weighted-Average Exercise Price, Outstanding, Beginning balance | $ 10.24 | |
Weighted-Average Exercise Price, Granted | 5.17 | |
Weighted-Average Exercise Price, Exercised | 8.98 | |
Weighted Average Exercise Price Per Option, Forfeited or cancelled | 12.06 | |
Weighted-Average Exercise Price, Outstanding, Ending balance | 9.16 | $ 10.24 |
Weighted-Average Exercise Price, vested and exercisable | $ 11.07 | |
Weighted Average Remaining Contractual Life, Ending balance | 7 years 9 months | 7 years 3 months |
Vested and exercisable as of March 31, 2022 | 6 years 2 months 19 days | |
Aggregate Intrinsic Value | $ 7,636 | $ 530 |
Aggregate Intrinsic Value, Vested and exercisable | $ 1,934 |
Stock-Based Compensation - Weig
Stock-Based Compensation - Weighted-average assumptions used in Black-Scholes Model to estimate fair value of stock options granted (Detail) | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Employees Stock Option [Member] | Minimum [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected term (in years) | 5 years 3 months 7 days | 5 years 3 months 7 days |
Employees Stock Option [Member] | Maximum [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected term (in years) | 6 years 29 days | 6 years 29 days |
Employees and Non Employees Stock Option [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Volatility, minimum | 68.71% | 72.39% |
Volatility, maximum | 70.75% | 100.87% |
Risk free interest rate, minimum | 1.76% | 0.62% |
Risk free interest rate, maximum | 2.41% | 1.16% |
Stock Based Compensation - Sche
Stock Based Compensation - Schedule of Nonvested Restricted Stock Units and Performance Stock Units Activity and Weighted Average Grant Date Fair Value (Detail) | 3 Months Ended |
Mar. 31, 2022$ / sharesshares | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Stock options granted | 1,353,300 |
Restricted Stock Units and Performance Stock Unit [Member] | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Unvested shares, beginning balance | 623,000 |
Stock options granted | 298,150 |
Vested, shares | (85,106) |
Forfeited | (33,225) |
Unvested shares, ending balance | 802,819 |
Weighted average grant-date fair value of options begining balance | $ / shares | $ 8.63 |
Weighted-average grant date fair value of employee option grants | $ / shares | 5.22 |
Weighted average grant-date fair value of options vested | $ / shares | 10.09 |
Weighted average grant-date fair value of options forfeited | $ / shares | 8.33 |
Weighted average grant-date fair value of options ending balance | $ / shares | $ 7.22 |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Non-cash Stock Based Compensation Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total stock-based compensation expense | $ 2,047 | $ 1,549 |
Research and Development [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total stock-based compensation expense | 625 | 391 |
Selling General And Administrative Expenses [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total stock-based compensation expense | $ 1,422 | $ 1,158 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Income Tax Disclosure [Abstract] | ||
Provision for income taxes | $ 9,000 | $ 19,000 |
Effective tax rate | 0.04% | 0.10% |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) | 1 Months Ended | 3 Months Ended | ||
Oct. 31, 2017USD ($)ft² | Mar. 31, 2022USD ($) | Mar. 31, 2021USD ($) | Dec. 31, 2021 | |
Other Commitments [Line Items] | ||||
Rent expense recognized for company's operating leases | $ 100,000 | $ 200,000 | ||
Variable lease payments for operating leases | 23,000 | 23,000 | ||
Operating cash outflows for operating lease liabilities | $ 200,000 | $ 200,000 | ||
Weighted-average remaining lease term | 10 months 24 days | 1 year 2 months 12 days | ||
Weighted-average discount rate | 9.15% | 9.15% | ||
Palo Alto, California [Member] | ||||
Other Commitments [Line Items] | ||||
Total leased space | ft² | 8,029 | |||
Lease commencement date | Mar. 1, 2018 | |||
Long-term operating lease expiry period month and year | 2023-02 | |||
Lease renewal term | 3 years | |||
Security deposit of collateral for lease | $ 300,000 |
Commitments and Contingencies_2
Commitments and Contingencies - Maturity of Operating Leases Liabilities and Future Minimum Lease Payments (Detail) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Commitments And Contingencies Disclosure [Abstract] | ||
Operating leases minimum payments, remaining in 2022 | $ 501 | |
Operating leases minimum payments, 2023 | 115 | |
Operating leases minimum payments, 2024 | 1 | |
Operating leases minimum payments, 2025 | 1 | |
Total undiscounted payments | 618 | |
Less: imputed interest | 24 | |
Present value of future lease payments | 594 | |
Less: current portion of operating lease liabilities | 590 | $ 628 |
Operating lease liabilities | $ 4 | $ 116 |
Net (Loss) Income Per Share - S
Net (Loss) Income Per Share - Schedule of Computation of Basic and Diluted Net (Loss) Income Per Common Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Numerator: | ||
Net (loss) income | $ (22,643) | $ 29,248 |
Denominator: | ||
Weighted-average shares outstanding for basic net (loss) income per share | 35,253,147 | 33,886,896 |
Effect of dilutive securities | 333,999 | |
Weighted-average shares outstanding for diluted net (loss) income per share | 35,253,147 | 34,220,895 |
Net (loss) income per share: | ||
Basic | $ (0.64) | $ 0.86 |
Diluted | $ (0.64) | $ 0.85 |
Net Income (Loss) Per Share - S
Net Income (Loss) Per Share - Summary of Potentially Dilutive Shares Excluded from Computation of Diluted Net (Loss) Income Per Share (Details) - shares | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive securities | 7,380,823 | 2,899,012 |
Options Granted to Employees and Non Employees [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive securities | 6,490,451 | 2,895,223 |
Restricted Stock Units (Unvested) [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive securities | 802,819 | |
ESPP [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive securities | 87,553 | 3,789 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Detail) - 2022 ATM Facility [Member] - USD ($) | Mar. 25, 2022 | Apr. 30, 2022 |
Subsequent Event [Line Items] | ||
Equity, debt, warrants and units, maximum issued and sale | $ 50,000,000 | |
Subsequent Event [Member] | ||
Subsequent Event [Line Items] | ||
Issuance of common stock upon public offering, net of issuance costs, shares | 2,686,288 | |
Net proceeds from issuance of common stock, Net of commissions | $ 20,800 |