Cover
Cover - shares | 9 Months Ended | |
Sep. 30, 2022 | Nov. 01, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2022 | |
Document Fiscal Year Focus | 2022 | |
Document Transition Report | false | |
Entity File Number | 001-36183 | |
Entity Registrant Name | Eiger BioPharmaceuticals, Inc. | |
Entity Incorporation, State or Country Code | DE | |
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 | |
Title of 12(b) Security | Common Stock (par value $0.001 per share) | |
Trading Symbol | EIGR | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 44,074,284 | |
Amendment Flag | false | |
Document Fiscal Period Focus | Q3 | |
Entity Central Index Key | 0001305253 | |
Current Fiscal Year End Date | --12-31 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 26,308 | $ 22,221 |
Short-term debt securities | 94,736 | 66,594 |
Accounts receivable, net | 2,458 | 2,576 |
Inventories | 2,817 | 2,612 |
Prepaid expenses and other current assets | 15,970 | 9,361 |
Total current assets | 142,289 | 103,364 |
Long-term debt securities | 0 | 17,262 |
Property and equipment, net | 511 | 613 |
Operating lease right-of-use assets | 246 | 653 |
Other assets | 698 | 4,510 |
Total assets | 143,744 | 126,402 |
Current liabilities: | ||
Accounts payable | 10,497 | 7,765 |
Accrued liabilities | 15,345 | 13,699 |
Current portion of operating lease liabilities | 277 | 628 |
Debt, current portion | 0 | 7,809 |
Total current liabilities | 26,119 | 29,901 |
Debt, net of current portion | 39,315 | 23,986 |
Operating lease liabilities | 2 | 116 |
Total liabilities | 65,436 | 54,003 |
Stockholders’ equity: | ||
Common stock | 44 | 35 |
Additional paid-in capital | 490,939 | 412,930 |
Accumulated other comprehensive loss | (620) | (149) |
Accumulated deficit | (412,055) | (340,417) |
Total stockholders’ equity | 78,308 | 72,399 |
Total liabilities and stockholders’ equity | $ 143,744 | $ 126,402 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Revenues [Abstract] | ||||
Total revenue | $ 4,024,000 | $ 3,039,000 | $ 10,788,000 | $ 8,782,000 |
Costs and operating expenses: | ||||
Cost of sales | 1,231,000 | 318,000 | 1,492,000 | 641,000 |
Research and development | 22,198,000 | 18,106,000 | 56,761,000 | 46,250,000 |
Selling, general and administrative | 6,964,000 | 6,466,000 | 20,804,000 | 17,916,000 |
Total costs and operating expenses | 30,393,000 | 24,890,000 | 79,057,000 | 64,807,000 |
Loss from operations | (26,369,000) | (21,851,000) | (68,269,000) | (56,025,000) |
Interest expense | (1,092,000) | (894,000) | (2,912,000) | (2,659,000) |
Interest income | 347,000 | 35,000 | 613,000 | 119,000 |
Other (expense) income, net | 3,000 | 503,000 | (1,044,000) | 46,462,000 |
Loss before provision for income taxes | (27,111,000) | (22,207,000) | (71,612,000) | (12,103,000) |
Provision for income taxes | 0 | 16,000 | 26,000 | 46,000 |
Net loss | $ (27,111,000) | $ (22,223,000) | $ (71,638,000) | $ (12,149,000) |
Net loss per common share: | ||||
Basic (in USD per share) | $ (0.62) | $ (0.65) | $ (1.76) | $ (0.36) |
Diluted (in USD per share) | $ (0.62) | $ (0.65) | $ (1.76) | $ (0.36) |
Weighted-average common shares outstanding: | ||||
Basic (in shares) | 44,010,553 | 33,946,559 | 40,806,581 | 33,922,080 |
Diluted (in shares) | 44,010,553 | 33,946,559 | 40,806,581 | 33,922,080 |
Product revenue, net | ||||
Revenues [Abstract] | ||||
Total revenue | $ 4,024,000 | $ 3,039,000 | $ 10,038,000 | $ 8,782,000 |
Other revenue | ||||
Revenues [Abstract] | ||||
Total revenue | $ 0 | $ 0 | $ 750,000 | $ 0 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Statement of Comprehensive Income [Abstract] | ||||
Net loss | $ (27,111) | $ (22,223) | $ (71,638) | $ (12,149) |
Other comprehensive loss: | ||||
Unrealized gain (loss) on available-for-sale debt securities, net | 141 | 7 | (471) | 9 |
Comprehensive loss | $ (26,970) | $ (22,216) | $ (72,109) | $ (12,140) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders’ Equity (Unaudited) - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit |
Balance, beginning of period (in shares) at Dec. 31, 2020 | 33,878,486 | ||||
Balance, beginning of period at Dec. 31, 2020 | $ 95,035 | $ 34 | $ 401,509 | $ (8) | $ (306,500) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock upon exercise of stock options (in shares) | 19,150 | ||||
Issuance of common stock upon exercise of stock options | 166 | 166 | |||
Vesting of common stock issued under Product Development Agreement | 53 | 53 | |||
Issuance of common stock upon ESPP purchase (in shares) | 19,928 | ||||
Issuance of common stock upon ESPP purchase | 136 | 136 | |||
Issuance of common stock upon release of restricted stock units (in shares) | 33,750 | ||||
Issuance of common stock upon release of restricted stock units | 0 | ||||
Stock-based compensation expense | 1,549 | 1,549 | |||
Unrealized gain/(loss) on available-for-sale debt securities, net | 3 | 3 | |||
Net loss | 29,248 | 29,248 | |||
Balance, end of period (in shares) at Mar. 31, 2021 | 33,951,314 | ||||
Balance, end of period at Mar. 31, 2021 | 126,190 | $ 34 | 403,413 | (5) | (277,252) |
Balance, beginning of period (in shares) at Dec. 31, 2020 | 33,878,486 | ||||
Balance, beginning of period at Dec. 31, 2020 | 95,035 | $ 34 | 401,509 | (8) | (306,500) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Unrealized gain/(loss) on available-for-sale debt securities, net | 9 | ||||
Net loss | (12,149) | ||||
Balance, end of period (in shares) at Sep. 30, 2021 | 33,975,800 | ||||
Balance, end of period at Sep. 30, 2021 | 89,465 | $ 34 | 408,079 | 1 | (318,649) |
Balance, beginning of period (in shares) at Mar. 31, 2021 | 33,951,314 | ||||
Balance, beginning of period at Mar. 31, 2021 | 126,190 | $ 34 | 403,413 | (5) | (277,252) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock | 52 | 52 | |||
Stock-based compensation expense | 2,058 | 2,058 | |||
Unrealized gain/(loss) on available-for-sale debt securities, net | (1) | (1) | |||
Net loss | (19,174) | (19,174) | |||
Balance, end of period (in shares) at Jun. 30, 2021 | 33,951,314 | ||||
Balance, end of period at Jun. 30, 2021 | 109,125 | $ 34 | 405,523 | (6) | (296,426) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Vesting of common stock issued under Product Development Agreement | 62 | 62 | |||
Issuance of common stock upon ESPP purchase (in shares) | 6,795 | ||||
Issuance of common stock upon ESPP purchase | 43 | 43 | |||
Issuance of common stock upon release of restricted stock units (in shares) | 17,691 | ||||
Issuance of common stock upon release of restricted stock units | 121 | 121 | |||
Stock-based compensation expense | 2,330 | 2,330 | |||
Unrealized gain/(loss) on available-for-sale debt securities, net | 7 | 7 | |||
Net loss | (22,223) | (22,223) | |||
Balance, end of period (in shares) at Sep. 30, 2021 | 33,975,800 | ||||
Balance, end of period at Sep. 30, 2021 | 89,465 | $ 34 | 408,079 | 1 | (318,649) |
Balance, beginning of period (in shares) at Dec. 31, 2021 | 34,568,821 | ||||
Balance, beginning of period at Dec. 31, 2021 | 72,399 | $ 35 | 412,930 | (149) | (340,417) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock (in shares) | 5,841,786 | ||||
Issuance of common stock | 45,610 | $ 6 | 45,604 | ||
Issuance of common stock upon exercise of stock options (in shares) | 15,995 | ||||
Issuance of common stock upon exercise of stock options | 144 | 144 | |||
Vesting of common stock issued under Product Development Agreement | 19 | 19 | |||
Issuance of common stock upon ESPP purchase (in shares) | 18,130 | ||||
Issuance of common stock upon ESPP purchase | 64 | 64 | |||
Issuance of common stock upon release of restricted stock units (in shares) | 85,106 | ||||
Issuance of common stock upon release of restricted stock units | 0 | ||||
Stock-based compensation expense | 2,047 | 2,047 | |||
Unrealized gain/(loss) on available-for-sale debt securities, net | (373) | (373) | |||
Net loss | (22,643) | (22,643) | |||
Balance, end of period (in shares) at Mar. 31, 2022 | 40,529,838 | ||||
Balance, end of period at Mar. 31, 2022 | 97,267 | $ 41 | 460,808 | (522) | (363,060) |
Balance, beginning of period (in shares) at Dec. 31, 2021 | 34,568,821 | ||||
Balance, beginning of period at Dec. 31, 2021 | $ 72,399 | $ 35 | 412,930 | (149) | (340,417) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock upon exercise of stock options (in shares) | 21,111 | ||||
Unrealized gain/(loss) on available-for-sale debt securities, net | $ (471) | ||||
Net loss | (71,638) | ||||
Balance, end of period (in shares) at Sep. 30, 2022 | 44,048,028 | ||||
Balance, end of period at Sep. 30, 2022 | 78,308 | $ 44 | 490,939 | (620) | (412,055) |
Balance, beginning of period (in shares) at Mar. 31, 2022 | 40,529,838 | ||||
Balance, beginning of period at Mar. 31, 2022 | 97,267 | $ 41 | 460,808 | (522) | (363,060) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock (in shares) | 2,686,288 | ||||
Issuance of common stock | 20,564 | $ 2 | 20,562 | ||
Issuance of common stock to lender (in shares) | 749,053 | ||||
Issuance of common stock to lender | 5,000 | $ 1 | 4,999 | ||
Issuance of common stock upon exercise of stock options (in shares) | 1,604 | ||||
Issuance of common stock upon exercise of stock options | 9 | 9 | |||
Stock-based compensation expense | 2,208 | 2,208 | |||
Unrealized gain/(loss) on available-for-sale debt securities, net | (239) | (239) | |||
Net loss | (21,884) | (21,884) | |||
Balance, end of period (in shares) at Jun. 30, 2022 | 43,966,783 | ||||
Balance, end of period at Jun. 30, 2022 | 102,925 | $ 44 | 488,586 | (761) | (384,944) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock upon exercise of stock options (in shares) | 3,512 | ||||
Issuance of common stock upon exercise of stock options | 27 | 27 | |||
Issuance of common stock upon ESPP purchase (in shares) | 29,985 | ||||
Issuance of common stock upon ESPP purchase | 104 | 104 | |||
Issuance of common stock upon release of restricted stock units (in shares) | 47,748 | ||||
Issuance of common stock upon release of restricted stock units | 0 | ||||
Stock-based compensation expense | 2,222 | 2,222 | |||
Unrealized gain/(loss) on available-for-sale debt securities, net | 141 | 141 | |||
Net loss | (27,111) | (27,111) | |||
Balance, end of period (in shares) at Sep. 30, 2022 | 44,048,028 | ||||
Balance, end of period at Sep. 30, 2022 | $ 78,308 | $ 44 | $ 490,939 | $ (620) | $ (412,055) |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Stockholders' Equity (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | |
Jun. 30, 2022 | Mar. 31, 2022 | |
Statement of Stockholders' Equity [Abstract] | ||
Stock issuance costs | $ 716 | $ 1,288 |
Condensed Consolidated Statem_5
Condensed Consolidated Statements of Cash Flow (Unaudited) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Operating activities | ||
Net loss | $ (71,638) | $ (12,149) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Gain from sale of priority review voucher | 0 | (46,493) |
Income related to asset purchase agreement | 0 | (281) |
Depreciation and amortization | 219 | 203 |
Inventory write down | 1,043 | 0 |
Amortization of debt securities premiums and discounts | 698 | 658 |
Loss on extinguishment of debt | 1,144 | 0 |
Non-cash interest expense | 867 | 577 |
Amortization of operating lease right-of-use assets | 407 | 399 |
Common stock issued under Product Development Agreement | 19 | 167 |
Stock-based compensation | 6,477 | 5,937 |
Change in operating assets and liabilities: | ||
Accounts receivable | 118 | (2,762) |
Inventories | (892) | (2,528) |
Prepaid expenses and other current assets | (2,181) | 493 |
Other assets | (616) | (837) |
Accounts payable | 2,722 | 2,218 |
Accrued liabilities | 1,315 | 257 |
Operating lease liabilities | (465) | (436) |
Net cash used in operating activities | (60,763) | (54,577) |
Investing activities | ||
Purchase of debt securities available-for-sale | (55,538) | (71,447) |
Proceeds from maturities of debt securities available-for-sale | 43,489 | 99,630 |
Proceeds related to asset purchase agreement | 0 | 281 |
Proceeds from sale of priority review voucher | 0 | 95,000 |
Payments related to priority review voucher | 0 | (48,507) |
Purchase of property and equipment | (116) | (92) |
Net cash (used in) provided by investing activities | (12,165) | 74,865 |
Financing activities | ||
Issuance of common stock upon offering at-the-market, net of commissions | 66,402 | 0 |
Proceeds from issuance of common stock to lender | 5,000 | 0 |
Proceeds from debt | 39,840 | 0 |
Repayment of debt | (33,277) | 0 |
Proceeds from issuance of common stock upon stock option exercises | 180 | 209 |
Proceeds from issuance of common stock upon ESPP purchase | 168 | 277 |
Payment of debt issuance costs | (1,054) | (175) |
Common stock offering costs | (244) | (208) |
Net cash provided by financing activities | 77,015 | 103 |
Net increase in cash and cash equivalents | 4,087 | 20,391 |
Cash and cash equivalents at beginning of period | 22,221 | 28,864 |
Cash and cash equivalents at end of period | 26,308 | 49,255 |
Supplemental disclosure of cash flow information: | ||
Interest paid | 2,038 | 2,082 |
Income taxes paid | $ 43 | $ 0 |
Description of Business
Description of Business | 9 Months Ended |
Sep. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Description of Business | 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 for 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 been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA). 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 is a first-in-class, type III, interferon. The FDA approved the Company’s first commercial product, Zokinvy ® (lonafarnib), to reduce risk of mortality of Hutchinson-Gilford progeria syndrome (HGPS) and for treatment of processing-deficient progeroid laminopathies (PL), collectively known as progeria, with either heterozygous LMNA mutation with progerin-like protein accumulation, or homozygous or compound heterozygous ZMPSTE24 mutations, on November 20, 2020. The Company announced that the European Commission approved its Marketing Authorization Application (MAA) for Zokinvy, under exceptional circumstances procedure on July 20, 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. There are currently no approved therapies for these disorders. The Company’s principal operations are based in Palo Alto, California, with a subsidiary in Ireland. The Company operates in one segment. Liquidity As of September 30, 2022, the Company had $121.0 million of cash, cash equivalents and short-term securities, comprised of $26.3 million of cash and cash equivalents and $94.7 million of short-term debt securities available-for-sale. The Company had an accumulated deficit of $412.1 million and negative cash flows from operating activities as of September 30, 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 | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 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 (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. The Company’s debt securities consist of available-for-sale securities that are classified as Level 2 because their value is based on valuations using significant inputs derived from, or corroborated by, observable market data. Unrealized gains and losses on available-for-sale debt 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 . Realized gains and losses on the sale of debt securities are determined using the specific-identification method and recorded in other (expense) income, net on the accompanying unaudited condensed consolidated statements of operations. 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 September 30, 2022 and December 31, 2021. The Company had no bad debt expense for the three and nine months ended September 30, 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. The Company wrote-down $1.0 million of inventories for the nine months ended September 30, 2022. There were no write-downs in prior periods. 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. To determine revenue recognition for contracts with customers, the Company performs the following five-step approach: (i) identify the contract, or contracts, with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when, or as, the performance obligation is satisfied. The five-step model is only applied to contracts when it is probable that the Company will collect substantially all of the consideration it is entitled to in exchange for the goods transferred to a customer. 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. The Company has received an extension of the ATU program and expects the program to continue until commercial reimbursement of Zokinvy is approved in France. 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 nine months ended September 30, 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. Other Revenue The Company’s other revenue consists of milestone payments from the Marketing and Distribution Agreement (MDA) with AnGes, Inc., which was executed in May 2022. The agreement provides AnGes with a right to use the Company's intellectual property (IP) and seek regulatory approval for and commercialization of Zokinvy in Japan. The Company will receive additional payments upon achievement of certain regulatory milestones. 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. Recent Accounting Pronouncements In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326) . The standard changes how entities will measure credit losses for most financial assets and certain other instruments that are not measured at fair value through net income. Financial assets measured at amortized cost will be presented at the net amount expected to be collected by using an allowance for credit losses. In April 2019, the FASB issued ASU No. 2019-04, Codification Improvements to Topic 326, Financial Instruments – Credit Losses, Topic 815, Derivatives and Hedging, and Topic 825, Financial Instruments, which clarifies and corrects certain unintended applications of the guidance contained in each of the amended Topics. Additionally, in May 2019, the FASB issued ASU No. 2019-05, Financial Instruments – Credit Losses (Topic 326), which provides an option 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) , which 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 standard provides optional expedients for facilitating the effects of the reference rate reform on financial reporting. For the Company, there are two applicable optional expedients for contract modifications permitted for contracts that are modified because of the reference rate reform and meet the scope guidance. The modifications of contracts within the scope of ASC Topic 470 should be accounted for prospectively adjusting the effective interest rate. The modifications of contracts within the scope of ASC Topic 842 should be accounted for as a continuation of the existing contracts with no reassessments of the lease classification and the discount rate or remeasurements of lease payments that otherwise would be required under ASC Topic 842 for modifications not accounted for as separate contracts. 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 adopted this standard when LIBOR was about to be discontinued and the adoption did not have a material impact on its unaudited condensed consolidated financial statements. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value MeasurementsFair 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 September 30, 2022 and December 31, 2021, the carrying amount of accounts receivable, prepaid expenses and other current assets, accounts payable and accrued liabilities approximated their estimated fair value due to their relatively short maturities. Management believes the terms of its long-term debt reflect current market conditions for an instrument with similar terms and maturity, therefore the carrying value of the Company’s debt approximated its fair value. 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 assets or liabilities classified as Level 3 as of September 30, 2022 and December 31, 2021. 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): September 30, 2022 Level 1 Level 2 Level 3 Total Financial assets: Money market funds $ 13,121 $ — $ — $ 13,121 Corporate debt securities — 40,088 — 40,088 Commercial paper — 10,874 — 10,874 U.S. government bonds — 43,774 — 43,774 Total $ 13,121 $ 94,736 $ — $ 107,857 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 September 30, 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): September 30, 2022 Amortized cost Unrealized gain Unrealized loss Estimated Fair Cash equivalents: Money market funds $ 13,121 $ — $ — $ 13,121 Total cash equivalents $ 13,121 $ — $ — $ 13,121 Debt securities: Corporate debt securities $ 40,398 $ — $ (310) $ 40,088 Commercial paper 10,874 — — 10,874 U.S. government bonds 44,084 — (310) 43,774 Total debt securities $ 95,356 $ — $ (620) $ 94,736 Classified as: Cash equivalents $ 13,121 Short-term debt securities 94,736 $ 107,857 December 31, 2021 Amortized cost Unrealized gain Unrealized loss Estimated Fair 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 n ot 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 nine months ended September 30, 2022, the Company did not recognize any other-than-temporary impairment losses. T |
Balance Sheet Components
Balance Sheet Components | 9 Months Ended |
Sep. 30, 2022 | |
Balance Sheet Related Disclosures [Abstract] | |
Balance Sheet Components | Balance Sheet Components Inventories Inventories consist of the following (in thousands): September 30, December 31, Raw materials $ 1,704 $ 1,056 Work-in-progress 1,009 1,468 Finished goods 104 88 Total inventories $ 2,817 $ 2,612 Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consist of the following (in thousands): September 30, December 31, Prepaid contract manufacturing costs $ 5,083 $ 3,695 Short term deposits 4,630 54 Prepaid research costs 3,103 3,253 Prepaid insurance 876 631 Prepaid marketing 484 469 Other 1,794 1,259 Total prepaid expenses and other current assets $ 15,970 $ 9,361 Accrued Liabilities Accrued liabilities consist of the following (in thousands): September 30, December 31, Contract manufacturing costs $ 4,453 $ 3,288 Contract research costs 4,098 4,760 Compensation and related benefits 3,530 3,131 Product revenue reserves 2,035 1,846 Other 1,229 674 Total accrued liabilities $ 15,345 $ 13,699 |
Bristol-Meyers Squibb License A
Bristol-Meyers Squibb License Agreement | 9 Months Ended |
Sep. 30, 2022 | |
Product Development Agreement [Abstract] | |
Bristol-Meyers Squibb License Agreement | 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 (peginterferon lambda or 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 in research |
Asset Purchase Agreements
Asset Purchase Agreements | 9 Months Ended |
Sep. 30, 2022 | |
Asset Purchase Agreements And Related License Agreements [Abstract] | |
Asset Purchase Agreement | Asset Purchase Agreement 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 (expense) income, net in the unaudited condensed consolidated statement of operations for the nine months ended September 30, 2021. |
Debt
Debt | 9 Months Ended |
Sep. 30, 2022 | |
Debt Disclosure [Abstract] | |
Debt | Debt Innovatus Term Loan On June 1, 2022 (Closing Date), the Company entered into a term loan and security agreement (Innovatus Loan) with Innovatus Life Sciences Lending Fund I, LP (Innovatus), providing for up to $75.0 million funded in three tranches with a maturity date of August 31, 2027. The floating per annum interest rate of the Innovatus Loan is equal to the sum of (a) the greater of (i) the Prime Rate published in the Money Rates section of the Wall Street Journal (or any successor thereto) and (ii) 3.5%, plus (b) 3.75%; provided that, at the election of the Borrower, up to 2.25% of such rate shall be payable in-kind until the third anniversary of the closing date. The Company is required to make monthly interest-only payments through July 1, 2027, after which the Company is required to make monthly amortizing payments, with the remaining balance of the principal plus accrued and unpaid interest due at maturity. 2.25% of the interest is payable in-kind for the first three years of the term by increasing the principal balance. Prepayments of the loan, in whole or in part, will be subject to an early prepayment fee which declines each year until the third anniversary date of the Closing Date, after which no prepayment fee is required. The Company is also required to pay an exit fee upon any payment or prepayment equal to 6.5% of the aggregate principal amount of the tranches funded under the Innovatus Loan. The Innovatus Loan contains customary representations, warranties, events of default and covenants of the Company and its subsidiaries, including a requirement to maintain a cash balance of not less than 5% of the aggregate principal amount of funded and outstanding loan terms at all times. The Innovatus Loan is secured by 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 Company was funded $40.0 million in June 2022 on the Closing Date under Tranche A. The remaining $35.0 million is divided into two tranches (Tranche B and Tranche C). The $17.5 million under each of Tranche B and Tranche C will be available for a period commencing on the later of (a) the first date that the Company achieves certain development and regulatory milestones applicable to each Tranche and (b) November 1, 2022. Both Tranche B and Tranche C draw periods end on the earlier of (a) June 30, 2024 or (b) an event of default. The Company identified a number of embedded derivatives that require bifurcation from the Innovatus Loan. These embedded features include mandatory prepayment upon an event of default or change in control and contingent rate increases. However, the fair value of these embedded features was deemed to be immaterial on the date of issuance. At each subsequent reporting period, the Company will reassess the fair value of the embedded features and will record a liability if the fair value of the features becomes material. In connection with the issuance of the Innovatus Loan, the Company recorded a debt discount of $0.2 million and capitalized debt issuance costs of $1.0 million. The discount and issuance costs will be amortized over the life of the loan. Interest expense for the Innovatus Loan for the three and nine months ended September 30, 2022 was $1.1 million and $1.4 million, respectively, and is inclusive of non-cash amortization of the debt discount and debt issuance costs and accretion of final payment. The carrying value of the Innovatus Loan at September 30, 2022 was $39.3 million. The carrying amount of the Innovatus Loan approximates fair value given its recent issuance. The effective interest rate for the Innovatus Loan was 11.59% as of September 30, 2022. Additionally, in connection with entering into the Innovatus Loan, the Company entered into a Stock Purchase Agreement with Innovatus for the sale of common stock with an aggregate value of $5.0 million. On June 1, 2022, the Company issued 749,053 shares of common stock to Innovatus at a per share purchase price of $6.6751, the preceding five-day volume weighted average price per share. A portion of the loan proceeds were used to repay in full the approximately $33.5 million of aggregate principal amount, unpaid interest, and exit fees in connection with loans outstanding owed to Oxford Finance LLC by the Company. Oxford Term Loan 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 borrowed the remaining $5.0 million (Tranche C) under the Oxford Loan. 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. 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 was being amortized over the remaining term of the Amended Oxford Loan. Interest expense for the Oxford Loan for the nine months ended September 30, 2022 was $1.5 million. On October 6, 2021, the Company entered into the sixth amendment to the Oxford Loan, which amended the interest to be 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 was required to pay an exit fee of 7.50% of the original principal balance of borrowed funds, or $2.3 million. In addition, the Company was required to pay an additional exit fee of $1.0 million. The Company recorded as a liability and debt discount the exit fee for the Amended Oxford Loan. At the date of the Amended Oxford Loan, the Company paid $0.9 million for the accrued portion of the Oxford Loan exit fee and the Tranche B additional exit fee. On June 1, 2022, upon entering into the Innovatus Loan, the Company repaid the Oxford Loan, including (i) the $30.0 million outstanding principal balances, (ii) $0.2 million in accrued and unpaid interest, and (iii) other final payments consisting of $3.3 million, for a total payment of $33.5 million. The Company recorded a loss of $1.1 million on early extinguishment of the debt related to the unamortized debt premium, discount, and cost of issuance, which was recognized as a component of other (expense) income, net in the condensed consolidated statement of operations and other comprehensive loss. The Company accounts for the amortization of the debt discount utilizing the effective interest method. Debt and unamortized discount balances are as follows (in thousands): September 30, December 31, Face value of debt $ 40,302 $ 30,000 Exit fee 2,600 3,277 Unamortized debt discount associated with exit fee, debt issuance costs and loan origination fees (3,587) (1,482) Total debt, net 39,315 31,795 Less: current portion of debt — (7,809) Debt, net $ 39,315 $ 23,986 |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2022 | |
Share-based Payment Arrangement [Abstract] | |
Stock-Based Compensation | 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 September 30, 2022, there were 380,000 shares remaining available to be issued under the 2021 Inducement Plan. The following table summarizes stock option activity, including restricted stock units (RSUs) and performance stock units (PSUs) available for grant activity, under the Company’s stock-based compensation plans during the nine months ended September 30, 2022 (in thousands, except option and share data): Shares Number of Weighted- Weighted- Aggregate Outstanding as of December 31, 2021 1,327,645 5,262,185 $ 10.24 7.25 $ 530 Additional options authorized 1,728,441 Granted (1,987,100) 1,987,100 $ 5.80 Restricted stock units granted (298,150) — Performance stock units granted (30,000) — Exercised (21,111) $ 8.50 Forfeited 351,495 (351,495) $ 9.74 Restricted stock units forfeited 64,940 — Outstanding as of September 30, 2022 1,157,271 6,876,679 $ 8.99 7.22 $ 5,877 Vested and exercisable as of September 30, 2022 3,724,985 $ 10.54 5.78 $ 2,148 During the three and nine months ended September 30, 2022, the weighted-average grant date fair value of options granted were $5.46 and $3.68 per share, respectively. During the three and nine months ended September 30, 2021, the weighted-average grant date fair value of options granted were $4.65 and $6.78 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 September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Expected term (in years) 5.77-6.08 5.77-6.08 5.27-6.08 5.27-6.08 Volatility 71.44%-73.08% 70.72%-71.62% 68.71%-73.08% 70.72%-100.87% Risk free interest rate 2.70%-4.02% 0.89%-1.15% 1.76%-4.02% 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 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 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, 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. During the three and nine months ended September 30, 2021, the Company granted 240,000 PSUs with a weighted-average grant date fair value of $8.15 per share. During the nine months ended September 30, 2022, the Company granted 30,000 PSUs, with a weighted-average grant date fair value of $6.87 per share. There were no PSUs granted during the three months ended September 30, 2022. As of September 30, 2022, no PSUs have vested as the performance-based metrics of the PSUs have not yet been achieved. There were no RSUs granted during the three months ended September 30, 2022. During the three months ended September 30, 2021, the Company granted 168,000 RSUs, with a weighted-average grant date fair value of $8.15 per share. During the nine months ended September 30, 2022 and 2021, the Company granted 298,150 and 371,500 RSUs, respectively, with a weighted-average grant date fair value of $5.22 and $9.16 per share, respectively. In relation to the RSUs granted, the Company recognized $0.5 million and $0.4 million in stock-based compensation expense for the three months ended September 30, 2022 and 2021, respectively, and $1.4 million and $0.7 million in stock-based compensation expense for the nine months ended September 30, 2022 and 2021, respectively, which were included in selling, general and administrative expenses. As of September 30, 2022, the total unrecognized compensation expense related to unvested RSUs and PSUs was $4.1 million, which the Company expects to recognize over an estimated weighted-average period of 2.30 years. The following table summarizes RSU and PSU activity and weighted average grant date fair value for the nine months ended September 30, 2022: Shares Weighted- Unvested shares as of December 31, 2021 623,000 $ 8.63 Granted 328,150 $ 5.37 Vested (132,854) $ 9.40 Forfeited (64,940) $ 7.95 Unvested shares as of September 30, 2022 753,356 $ 7.13 Stock-Based Compensation Expense Total stock-based compensation expense recognized was as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Research and development $ 856 $ 686 $ 2,301 $ 1,627 Selling, general and administrative 1,366 1,644 4,176 4,310 Total $ 2,222 $ 2,330 $ 6,477 $ 5,937 As of September 30, 2022, the total unrecognized compensation expense related to unvested options was $13.7 million, which the Company expects to recognize over an estimated weighted average period of 2.8 years. |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income TaxesThe Company’s provision for income taxes was approximately $0 and $26,000 for the three and nine months ended September 30, 2022, respectively, with an effective tax rate of (0.04)% for the nine months ended September 30, 2022. The Company's provision for income taxes was approximately $16,000 and $46,000 for the three and nine months ended September 30, 2021, with an effective tax rate of (0.3)% for the nine months ended September 30, 2021. 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 nine months ended September 30, 2022 relates to state taxes. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2022 | |
Leases [Abstract] | |
Commitments and Contingencies | 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 renewal option prior to expiration; and the Company is evaluating its plans and is not yet reasonably assured to exercise this option. The lease includes rent escalation clauses throughout the lease term. In October 2017, the Company provided a security deposit of $0.3 million. The Company also has additional operating leases that are included in its lease accounting but are not considered significant for disclosure. The maturities of the Company’s operating lease liabilities as of September 30, 2022 were as follows (in thousands): Undiscounted lease payments September 30, 2022 Remaining in 2022 $ 167 2023 115 2024 1 2025 1 Total undiscounted payments 284 Less: imputed interest 5 Present value of future lease payments 279 Less: current portion of operating lease liabilities 277 Operating lease liabilities $ 2 Rent expense recognized for the Company’s operating leases was $0.1 million for the three months ended September 30, 2022 and 2021, and $0.4 million for the nine months ended September 30, 2022 and 2021. 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 were $23,000 for the three months ended September 30, 2022 and 2021 and $0.1 million for the nine months ended September 30, 2022 and 2021. |
Net Loss Per Share
Net Loss Per Share | 9 Months Ended |
Sep. 30, 2022 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | Net Loss 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 September 30, 2022 and 2021, and nine months ended September 30, 2022 and 2021, 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. 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 outstanding potentially dilutive securities which have been excluded in the calculation of diluted net loss per share because including such securities would be anti-dilutive (in common stock equivalent shares): Three Months Ended Nine Months Ended 2022 2021 2022 2021 Options to purchase common stock 6,876,679 5,378,092 6,876,679 5,378,092 Restricted stock units (unvested) 753,356 627,088 753,356 627,088 ESPP 85,110 36,431 85,110 37,409 Total 7,715,145 6,041,611 7,715,145 6,042,589 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 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 (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. The Company’s debt securities consist of available-for-sale securities that are classified as Level 2 because their value is based on valuations using significant inputs derived from, or corroborated by, observable market data. Unrealized gains and losses on available-for-sale debt 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 . Realized gains and losses on the sale of debt securities are determined using the specific-identification method and recorded in other (expense) income, net on the accompanying unaudited condensed consolidated statements of operations. |
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. |
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. |
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. To determine revenue recognition for contracts with customers, the Company performs the following five-step approach: (i) identify the contract, or contracts, with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when, or as, the performance obligation is satisfied. The five-step model is only applied to contracts when it is probable that the Company will collect substantially all of the consideration it is entitled to in exchange for the goods transferred to a customer. 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. The Company has received an extension of the ATU program and expects the program to continue until commercial reimbursement of Zokinvy is approved in France. 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 nine months ended September 30, 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. Other Revenue The Company’s other revenue consists of milestone payments from the Marketing and Distribution Agreement (MDA) with AnGes, Inc., which was executed in May 2022. The agreement provides AnGes with a right to use the Company's |
Cost of Sales | Cost of SalesCost 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. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326) . The standard changes how entities will measure credit losses for most financial assets and certain other instruments that are not measured at fair value through net income. Financial assets measured at amortized cost will be presented at the net amount expected to be collected by using an allowance for credit losses. In April 2019, the FASB issued ASU No. 2019-04, Codification Improvements to Topic 326, Financial Instruments – Credit Losses, Topic 815, Derivatives and Hedging, and Topic 825, Financial Instruments, which clarifies and corrects certain unintended applications of the guidance contained in each of the amended Topics. Additionally, in May 2019, the FASB issued ASU No. 2019-05, Financial Instruments – Credit Losses (Topic 326), which provides an option 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) , which 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 standard provides optional expedients for facilitating the effects of the reference rate reform on financial reporting. For the Company, there are two applicable optional expedients for contract modifications permitted for contracts that are modified because of the reference rate reform and meet the scope guidance. The modifications of contracts within the scope of ASC Topic 470 should be accounted for prospectively adjusting the effective interest rate. The modifications of contracts within the scope of ASC Topic 842 should be accounted for as a continuation of the existing contracts with no reassessments of the lease classification and the discount rate or remeasurements of lease payments that otherwise would be required under ASC Topic 842 for modifications not accounted for as separate contracts. 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 adopted this standard when LIBOR was about to be discontinued and the adoption did not have a material impact on its unaudited condensed consolidated financial statements. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 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): September 30, 2022 Level 1 Level 2 Level 3 Total Financial assets: Money market funds $ 13,121 $ — $ — $ 13,121 Corporate debt securities — 40,088 — 40,088 Commercial paper — 10,874 — 10,874 U.S. government bonds — 43,774 — 43,774 Total $ 13,121 $ 94,736 $ — $ 107,857 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): September 30, 2022 Amortized cost Unrealized gain Unrealized loss Estimated Fair Cash equivalents: Money market funds $ 13,121 $ — $ — $ 13,121 Total cash equivalents $ 13,121 $ — $ — $ 13,121 Debt securities: Corporate debt securities $ 40,398 $ — $ (310) $ 40,088 Commercial paper 10,874 — — 10,874 U.S. government bonds 44,084 — (310) 43,774 Total debt securities $ 95,356 $ — $ (620) $ 94,736 Classified as: Cash equivalents $ 13,121 Short-term debt securities 94,736 $ 107,857 December 31, 2021 Amortized cost Unrealized gain Unrealized loss Estimated Fair 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) | 9 Months Ended |
Sep. 30, 2022 | |
Balance Sheet Related Disclosures [Abstract] | |
Schedule of Inventory | Inventories consist of the following (in thousands): September 30, December 31, Raw materials $ 1,704 $ 1,056 Work-in-progress 1,009 1,468 Finished goods 104 88 Total inventories $ 2,817 $ 2,612 |
Schedule of Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets consist of the following (in thousands): September 30, December 31, Prepaid contract manufacturing costs $ 5,083 $ 3,695 Short term deposits 4,630 54 Prepaid research costs 3,103 3,253 Prepaid insurance 876 631 Prepaid marketing 484 469 Other 1,794 1,259 Total prepaid expenses and other current assets $ 15,970 $ 9,361 |
Schedule of Components of Accrued Liabilities | Accrued liabilities consist of the following (in thousands): September 30, December 31, Contract manufacturing costs $ 4,453 $ 3,288 Contract research costs 4,098 4,760 Compensation and related benefits 3,530 3,131 Product revenue reserves 2,035 1,846 Other 1,229 674 Total accrued liabilities $ 15,345 $ 13,699 |
Debt (Tables)
Debt (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Debt Disclosure [Abstract] | |
Schedule of Long-Term Debt and Unamortized Discount Balances | Debt and unamortized discount balances are as follows (in thousands): September 30, December 31, Face value of debt $ 40,302 $ 30,000 Exit fee 2,600 3,277 Unamortized debt discount associated with exit fee, debt issuance costs and loan origination fees (3,587) (1,482) Total debt, net 39,315 31,795 Less: current portion of debt — (7,809) Debt, net $ 39,315 $ 23,986 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Share-based Payment Arrangement [Abstract] | |
Stock Option Activity | The following table summarizes stock option activity, including restricted stock units (RSUs) and performance stock units (PSUs) available for grant activity, under the Company’s stock-based compensation plans during the nine months ended September 30, 2022 (in thousands, except option and share data): Shares Number of Weighted- Weighted- Aggregate Outstanding as of December 31, 2021 1,327,645 5,262,185 $ 10.24 7.25 $ 530 Additional options authorized 1,728,441 Granted (1,987,100) 1,987,100 $ 5.80 Restricted stock units granted (298,150) — Performance stock units granted (30,000) — Exercised (21,111) $ 8.50 Forfeited 351,495 (351,495) $ 9.74 Restricted stock units forfeited 64,940 — Outstanding as of September 30, 2022 1,157,271 6,876,679 $ 8.99 7.22 $ 5,877 Vested and exercisable as of September 30, 2022 3,724,985 $ 10.54 5.78 $ 2,148 |
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 September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Expected term (in years) 5.77-6.08 5.77-6.08 5.27-6.08 5.27-6.08 Volatility 71.44%-73.08% 70.72%-71.62% 68.71%-73.08% 70.72%-100.87% Risk free interest rate 2.70%-4.02% 0.89%-1.15% 1.76%-4.02% 0.62%-1.16% Dividend yield — — — — |
Schedule of Nonvested Restricted Stock Units and Performance 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 nine months ended September 30, 2022: Shares Weighted- Unvested shares as of December 31, 2021 623,000 $ 8.63 Granted 328,150 $ 5.37 Vested (132,854) $ 9.40 Forfeited (64,940) $ 7.95 Unvested shares as of September 30, 2022 753,356 $ 7.13 |
Summary of Non-cash Stock Based Compensation Expense | Total stock-based compensation expense recognized was as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Research and development $ 856 $ 686 $ 2,301 $ 1,627 Selling, general and administrative 1,366 1,644 4,176 4,310 Total $ 2,222 $ 2,330 $ 6,477 $ 5,937 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Leases [Abstract] | |
Maturity of Operating Leases Liabilities and Future Minimum Lease Payments | The maturities of the Company’s operating lease liabilities as of September 30, 2022 were as follows (in thousands): Undiscounted lease payments September 30, 2022 Remaining in 2022 $ 167 2023 115 2024 1 2025 1 Total undiscounted payments 284 Less: imputed interest 5 Present value of future lease payments 279 Less: current portion of operating lease liabilities 277 Operating lease liabilities $ 2 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Earnings Per Share [Abstract] | |
Summary of Potentially Dilutive Shares Excluded from Computation of Diluted Net Loss Per Share | The following table sets forth the outstanding potentially dilutive securities which have been excluded in the calculation of diluted net loss per share because including such securities would be anti-dilutive (in common stock equivalent shares): Three Months Ended Nine Months Ended 2022 2021 2022 2021 Options to purchase common stock 6,876,679 5,378,092 6,876,679 5,378,092 Restricted stock units (unvested) 753,356 627,088 753,356 627,088 ESPP 85,110 36,431 85,110 37,409 Total 7,715,145 6,041,611 7,715,145 6,042,589 |
Description of Business - Addit
Description of Business - Additional Information (Detail) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 USD ($) segment | Dec. 31, 2021 USD ($) | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Number of operating segments | segment | 1 | |
Cash, cash equivalents and short-term investments | $ 121,000 | |
Cash and cash equivalents | 26,308 | $ 22,221 |
Debt securities, available-for-sale | 94,700 | |
Accumulated deficit | $ (412,055) | $ (340,417) |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Detail) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Jun. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2020 | Dec. 31, 2021 | |
Product Information [Line Items] | |||||||
Accounts receivable, allowance for doubtful accounts | $ 0 | $ 0 | $ 0 | ||||
Bad debt expense | 0 | $ 0 | 0 | $ 0 | |||
Inventory write down | 0 | 1,043,000 | 0 | ||||
Early access program term (in years) | 1 year | ||||||
Total revenue | 4,024,000 | 3,039,000 | 10,788,000 | 8,782,000 | |||
Product revenue, net | |||||||
Product Information [Line Items] | |||||||
Total revenue | $ 4,024,000 | $ 3,039,000 | 10,038,000 | $ 8,782,000 | $ 0 | ||
Autorisation Temporaire D Utlisation Member | |||||||
Product Information [Line Items] | |||||||
Total revenue | $ 0 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) - USD ($) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets | $ 107,857,000 | $ 97,376,000 |
Financial liabilities | 0 | 0 |
Other-than-temporary impairment losses | 0 | |
Debt securities, unrealized loss | 620,000 | 149,000 |
Debt securities, unrealized loss position for more than 12 months | 100,000 | |
Level 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets | 0 | 0 |
Transfers in or out of level 3 | 0 | 0 |
Financial liabilities | $ 0 | $ 0 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Assets and Liabilities Measured at Fair Value (Detail) - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
Financial assets: | ||
Financial assets | $ 107,857,000 | $ 97,376,000 |
Corporate debt securities | ||
Financial assets: | ||
Financial assets | 40,088,000 | 41,511,000 |
Commercial paper | ||
Financial assets: | ||
Financial assets | 10,874,000 | |
U.S. government bonds | ||
Financial assets: | ||
Financial assets | 43,774,000 | 42,345,000 |
Money market funds | ||
Financial assets: | ||
Financial assets | 13,121,000 | 13,520,000 |
Level 1 | ||
Financial assets: | ||
Financial assets | 13,121,000 | 13,520,000 |
Level 1 | Corporate debt securities | ||
Financial assets: | ||
Financial assets | 0 | 0 |
Level 1 | Commercial paper | ||
Financial assets: | ||
Financial assets | 0 | |
Level 1 | U.S. government bonds | ||
Financial assets: | ||
Financial assets | 0 | 0 |
Level 1 | Money market funds | ||
Financial assets: | ||
Financial assets | 13,121,000 | 13,520,000 |
Level 2 | ||
Financial assets: | ||
Financial assets | 94,736,000 | 83,856,000 |
Level 2 | Corporate debt securities | ||
Financial assets: | ||
Financial assets | 40,088,000 | 41,511,000 |
Level 2 | Commercial paper | ||
Financial assets: | ||
Financial assets | 10,874,000 | |
Level 2 | U.S. government bonds | ||
Financial assets: | ||
Financial assets | 43,774,000 | 42,345,000 |
Level 2 | Money market funds | ||
Financial assets: | ||
Financial assets | 0 | 0 |
Level 3 | ||
Financial assets: | ||
Financial assets | 0 | 0 |
Level 3 | Corporate debt securities | ||
Financial assets: | ||
Financial assets | 0 | 0 |
Level 3 | Commercial paper | ||
Financial assets: | ||
Financial assets | 0 | |
Level 3 | U.S. government bonds | ||
Financial assets: | ||
Financial assets | 0 | 0 |
Level 3 | Money market funds | ||
Financial assets: | ||
Financial assets | $ 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 | Sep. 30, 2022 | Dec. 31, 2021 |
Cash Equivalents and Investment Securities [Line Items] | ||
Cash equivalents, Amortized cost | $ 13,121 | $ 13,520 |
Cash equivalents, Estimated Fair Value | 13,121 | 13,520 |
Debt securities, Amortized cost | 95,356 | 84,005 |
Debt securities, Unrealized gain | 0 | 0 |
Debt securities, unrealized loss | 620 | 149 |
Debt securities, Estimated Fair Value | 94,736 | 83,856 |
Assets, Fair Value | 107,857 | 97,376 |
Corporate debt securities | ||
Cash Equivalents and Investment Securities [Line Items] | ||
Debt securities, Amortized cost | 40,398 | 41,576 |
Debt securities, Unrealized gain | 0 | 0 |
Debt securities, unrealized loss | 310 | 65 |
Debt securities, Estimated Fair Value | 40,088 | 41,511 |
Assets, Fair Value | 40,088 | 41,511 |
Commercial paper | ||
Cash Equivalents and Investment Securities [Line Items] | ||
Debt securities, Amortized cost | 10,874 | |
Debt securities, Unrealized gain | 0 | |
Debt securities, unrealized loss | 0 | |
Debt securities, Estimated Fair Value | 10,874 | |
Assets, Fair Value | 10,874 | |
U.S. government bonds | ||
Cash Equivalents and Investment Securities [Line Items] | ||
Debt securities, Amortized cost | 44,084 | 42,429 |
Debt securities, Unrealized gain | 0 | 0 |
Debt securities, unrealized loss | 310 | 84 |
Debt securities, Estimated Fair Value | 43,774 | 42,345 |
Assets, Fair Value | 43,774 | 42,345 |
Short-term debt securities | ||
Cash Equivalents and Investment Securities [Line Items] | ||
Debt securities, Estimated Fair Value | 94,736 | 66,594 |
Long-term debt securities | ||
Cash Equivalents and Investment Securities [Line Items] | ||
Debt securities, Estimated Fair Value | 17,262 | |
Money market funds | ||
Cash Equivalents and Investment Securities [Line Items] | ||
Cash equivalents, Amortized cost | 13,121 | 13,520 |
Cash equivalents, Estimated Fair Value | 13,121 | 13,520 |
Assets, Fair Value | 13,121 | 13,520 |
Cash equivalents | ||
Cash Equivalents and Investment Securities [Line Items] | ||
Cash equivalents, Estimated Fair Value | $ 13,121 | $ 13,520 |
Balance Sheet Components - Sche
Balance Sheet Components - Schedule of Inventory (Detail) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Balance Sheet Related Disclosures [Abstract] | ||
Raw materials | $ 1,704 | $ 1,056 |
Work-in-progress | 1,009 | 1,468 |
Finished goods | 104 | 88 |
Total inventories | $ 2,817 | $ 2,612 |
Balance Sheet Components - Sc_2
Balance Sheet Components - Schedule of Prepaid Expenses and Other Current Assets (Detail) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Balance Sheet Related Disclosures [Abstract] | ||
Prepaid contract manufacturing costs | $ 5,083 | $ 3,695 |
Short term deposits | 4,630 | 54 |
Prepaid research costs | 3,103 | 3,253 |
Prepaid insurance | 876 | 631 |
Prepaid marketing | 484 | 469 |
Other | 1,794 | 1,259 |
Total prepaid expenses and other current assets | $ 15,970 | $ 9,361 |
Balance Sheet Components - Sc_3
Balance Sheet Components - Schedule of Components of Accrued Liabilities (Detail) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Balance Sheet Related Disclosures [Abstract] | ||
Contract manufacturing costs | $ 4,453 | $ 3,288 |
Contract research costs | 4,098 | 4,760 |
Compensation and related benefits | 3,530 | 3,131 |
Product revenue reserves | 2,035 | 1,846 |
Other | 1,229 | 674 |
Total accrued liabilities | $ 15,345 | $ 13,699 |
Bristol-Meyers Squibb License_2
Bristol-Meyers Squibb License Agreement - Additional Information (Detail) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | |||
Mar. 31, 2022 | Apr. 30, 2016 | Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2021 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Value of common stock issued during period | $ 20,564 | $ 45,610 | $ 52 | ||
Common Stock | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Issuance of common stock (in shares) | 2,686,288 | 5,841,786 | |||
Value of common stock issued during period | $ 2 | $ 6 | |||
Licensing Agreements | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Up front cash payments | $ 2,000 | ||||
BMS Transaction | Common Stock | Purchase Agreement | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Issuance of common stock (in shares) | 157,587 | ||||
Value of common stock issued during period | $ 3,200 | ||||
BMS Transaction | Licensing Agreements | Development And Regulatory Milestones | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Milestone obligations | 61,000 | ||||
BMS Transaction | Licensing Agreements | Commercial Sales | Maximum | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Milestone obligations | 128,000 | ||||
BMS Transaction | Licensing Agreements | Development Phase Two [Domain] | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Milestone obligations | $ 3,000 | ||||
BMS Transaction | Licensing Agreements | Development Phase Three | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Milestone obligations | $ 5,000 |
Asset Purchase Agreements - Add
Asset Purchase Agreements - Additional Information (Detail) - AbbVie Asset Purchase Agreement - USD ($) $ in Millions | 9 Months Ended | |
Nov. 20, 2020 | Sep. 30, 2021 | |
Asset Purchase Agreement And Related License Agreement [Line Items] | ||
Payment for asset purchase agreement | $ 95 | |
Progeria Research Foundation (PRF) Collaboration Agreement | ||
Asset Purchase Agreement And Related License Agreement [Line Items] | ||
Proceeds from sale | $ 46.5 |
Debt - Additional Information (
Debt - Additional Information (Detail) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | |||||||||||||
Jun. 01, 2022 USD ($) $ / shares shares | Oct. 06, 2021 USD ($) | Feb. 23, 2021 USD ($) | Mar. 05, 2019 USD ($) | Sep. 30, 2022 USD ($) | Jun. 30, 2022 USD ($) | Mar. 31, 2022 USD ($) | Sep. 30, 2021 USD ($) | Jun. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Dec. 31, 2021 USD ($) | Aug. 03, 2018 USD ($) | May 31, 2018 USD ($) | Dec. 31, 2016 USD ($) | |
Debt Instrument [Line Items] | |||||||||||||||
Face value of term loan | $ 40,302 | $ 40,302 | $ 30,000 | ||||||||||||
Interest expense | 1,092 | $ 894 | 2,912 | $ 2,659 | |||||||||||
Carrying value of debt | 39,315 | 39,315 | 23,986 | ||||||||||||
Value of common stock issued during period | $ 20,564 | $ 45,610 | $ 52 | ||||||||||||
Loan final repayment exit fees payable | 2,600 | 2,600 | $ 3,277 | ||||||||||||
Loss on extinguishment of debt | 1,144 | $ 0 | |||||||||||||
Oxford Loan | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Interest expense | 1,500 | ||||||||||||||
Oxford Loan | Amended Tranche A | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Loan outstanding | $ 30,000 | ||||||||||||||
Amended Oxford Loan | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Loan agreement, aggregate borrowing capacity | 35,000 | ||||||||||||||
Percentage of exit fee on principal balance | 7.50% | ||||||||||||||
Loan outstanding | 23,300 | ||||||||||||||
Borrowings from loan agreement | 6,700 | ||||||||||||||
Loan final repayment exit fees payable | $ 2,300 | ||||||||||||||
Loan final repayment additional exit fees payable | 1,000 | ||||||||||||||
Amended Oxford Loan | Secured Debt, Tranche B | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Repayments of loan agreement exit fee | $ 900 | ||||||||||||||
Amended Oxford Loan | Secured Debt, Amended Tranche B | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Loan agreement, remaining borrowing capacity | $ 5,000 | ||||||||||||||
Fifth Amended Oxford Loan | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Interest payment period | 17 months | ||||||||||||||
Principal and interest payment period | 19 months | ||||||||||||||
Amendment fees payment | $ 200 | ||||||||||||||
Line of Credit | Secured Debt | Innovatus Stock Purchase Agreement | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Value of common stock issued during period | $ 5,000 | ||||||||||||||
Sale of common stock, shares issued (in shares) | shares | 749,053 | ||||||||||||||
Sale of common stock (in USD per share) | $ / shares | $ 6.6751 | ||||||||||||||
Line of Credit | Innovatus Loan | Secured Debt | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Loan agreement, aggregate borrowing capacity | $ 75,000 | ||||||||||||||
Debt Instrument, percent of interest due (in percent) | 0.0225 | ||||||||||||||
Percentage of exit fee on principal balance | 6.50% | ||||||||||||||
Minimum cash balance of face value of loan (in percent) | 0.05 | ||||||||||||||
Debt discount | 200 | 200 | |||||||||||||
Capitalized debt issuance costs | 1,000 | 1,000 | |||||||||||||
Interest expense | 1,100 | 1,400 | |||||||||||||
Carrying value of debt | $ 39,300 | $ 39,300 | |||||||||||||
Effective interest rate | 11.59% | ||||||||||||||
Line of Credit | Innovatus Loan | Secured Debt | Variable Rate Component One | Minimum | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Minimum prime rate | 3.50% | ||||||||||||||
Line of Credit | Innovatus Loan | Secured Debt | Variable Rate Component Two | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Minimum prime rate | 3.75% | ||||||||||||||
Line of Credit | Innovatus Loan | Secured Debt, Tranche A | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Face value of term loan | 40,000 | ||||||||||||||
Line of Credit | Innovatus Loan | Secured Debt, Tranche B | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Face value of term loan | 17,500 | ||||||||||||||
Line of Credit | Innovatus Loan | Secured Debt, Tranche B and C | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Face value of term loan | $ 35,000 | ||||||||||||||
Line of Credit | Oxford Loan | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Loan agreement, aggregate borrowing capacity | $ 25,000 | ||||||||||||||
Line of Credit | Oxford Loan | Secured Debt | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Face value of term loan | $ 33,500 | ||||||||||||||
Line of Credit | Oxford Loan | Secured Debt, Tranche A | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Face value of term loan | $ 15,000 | ||||||||||||||
Line of Credit | Amendment | Secured Debt, Tranche B | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Face value of term loan | $ 5,000 | ||||||||||||||
Line of Credit | Amendment | Secured Debt, Tranche C | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Face value of term loan | $ 5,000 | ||||||||||||||
Line of Credit | Amended Oxford Loan | Amended Tranche A | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Loan agreement, aggregate borrowing capacity | 30,000 | ||||||||||||||
Repayments of loan agreement exit fee | 33,500 | ||||||||||||||
Accrued and unpaid interest | 200 | ||||||||||||||
Loss on extinguishment of debt | $ 1,100 | ||||||||||||||
Other final payments | $ 3,300 |
Debt - Schedule of Long-Term De
Debt - Schedule of Long-Term Debt and Unamortized Discount Balances (Detail) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Debt Disclosure [Abstract] | ||
Face value of debt | $ 40,302 | $ 30,000 |
Exit fee | 2,600 | 3,277 |
Unamortized debt discount associated with exit fee, debt issuance costs and loan origination fees | (3,587) | (1,482) |
Total debt, net | 39,315 | 31,795 |
Less: current portion of debt | 0 | (7,809) |
Debt, net of current portion | $ 39,315 | $ 23,986 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2022 | Sep. 30, 2021 | Jun. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Stock-based compensation expense | $ 2,222 | $ 2,330 | $ 6,477 | $ 5,937 | |
Total unrecognized compensation expense | $ 13,700 | $ 13,700 | |||
Weighted-average period for recognition (in years) | 2 years 9 months 18 days | ||||
Stock Options | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Weighted-average grant date fair value of employee option grants (in USD per share) | $ 5.46 | $ 4.65 | $ 3.68 | $ 6.78 | |
Restricted Stock Units (RSU) | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Common stock available for grant (in shares) | 298,150 | 168,000 | 371,500 | ||
Weighted-average grant date fair value of employee stock award grants (in USD per share) | $ 5.22 | $ 8.15 | $ 9.16 | ||
Vested (in shares) | 0 | ||||
Stock-based compensation expense | $ 500 | $ 400 | $ 1,400 | $ 700 | |
Total unrecognized compensation expense | $ 4,100 | $ 4,100 | |||
Weighted-average period for recognition (in years) | 2 years 3 months 18 days | ||||
Performance Stock Units (PSU) | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Common stock available for grant (in shares) | 0 | 240,000 | 30,000 | 240,000 | |
Weighted-average grant date fair value of employee stock award grants (in USD per share) | $ 8.15 | $ 6.87 | $ 8.15 | ||
Vested (in shares) | 0 | ||||
Total unrecognized compensation expense | $ 4,100 | $ 4,100 | |||
Weighted-average period for recognition (in years) | 2 years 3 months 18 days | ||||
Inducement Plan 2021 | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Common stock available for grant (in shares) | 850,000 | ||||
Number of shares available to be issued (in shares) | 380,000 | 380,000 |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock Option Activity (Detail) $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 USD ($) $ / shares shares | Dec. 31, 2021 USD ($) $ / shares shares | |
Shares Available for Grants | ||
Shares available for grants, outstanding, beginning balance (in shares) | 1,327,645 | |
Shares available for grants, additional options authorized (in shares) | 1,728,441 | |
Shares available for grants, granted (in shares) | (1,987,100) | |
Shares available for grants, restricted stock units granted (in shares) | (298,150) | |
Shares available for grants, performance stock units granted (in shares) | (30,000) | |
Shares available for grants, forfeited (in shares) | 351,495 | |
Shares available for grants, restricted stock units forfeited (in shares) | 64,940 | |
Shares available for grants, outstanding, ending balance (in shares) | 1,157,271 | 1,327,645 |
Number of Options | ||
Number of options, outstanding, beginning balance (in shares) | 5,262,185 | |
Number of options, granted (in shares) | 1,987,100 | |
Number of options, exercised (in shares) | (21,111) | |
Number of options, forfeited (in shares) | (351,495) | |
Number of options, outstanding, ending balance (in shares) | 6,876,679 | 5,262,185 |
Number of options, vested and exercisable (in shares) | 3,724,985 | |
Weighted- Average Exercise Price | ||
Weighted-average exercise price, outstanding, beginning balance (in USD per share) | $ / shares | $ 10.24 | |
Weighted-average exercise price, granted (in USD per share) | $ / shares | 5.80 | |
Weighted-average exercise price, exercised (in USD per share) | $ / shares | 8.50 | |
Weighted-average exercise price, forfeited (in USD per share) | $ / shares | 9.74 | |
Weighted-average exercise price, outstanding, ending balance (in USD per share) | $ / shares | 8.99 | $ 10.24 |
Weighted-average exercise price, vested and exercisable (in USD per share) | $ / shares | $ 10.54 | |
Stock Options Additional Disclosures | ||
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsOutstandingWeightedAverageRemainingContractualTerm2 | 7 years 2 months 19 days | 7 years 3 months |
Aggregate intrinsic value, beginning balance | $ | $ 530 | |
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsOutstandingWeightedAverageRemainingContractualTerm2 | 7 years 2 months 19 days | 7 years 3 months |
Aggregate intrinsic value, ending balance | $ | $ 5,877 | $ 530 |
Weighted average remaining contractual life, vested and exercisable (in years) | 5 years 9 months 10 days | |
Aggregate intrinsic value, vested and exercisable | $ | $ 2,148 |
Stock-Based Compensation - Weig
Stock-Based Compensation - Weighted-average assumptions used in Black-Scholes Model to estimate fair value of stock options granted (Detail) - Stock Options | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Volatility, minimum | 71.44% | 70.72% | 68.71% | 70.72% |
Volatility, maximum | 73.08% | 71.62% | 73.08% | 100.87% |
Risk free interest rate, minimum | 2.70% | 0.89% | 1.76% | 0.62% |
Risk free interest rate, maximum | 4.02% | 1.15% | 4.02% | 1.16% |
Dividend yield | 0% | 0% | 0% | 0% |
Minimum | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Expected term (in years) | 5 years 9 months 7 days | 5 years 9 months 7 days | 5 years 3 months 7 days | 5 years 3 months 7 days |
Maximum | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Expected term (in years) | 6 years 29 days | 6 years 29 days | 6 years 29 days | 6 years 29 days |
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) - Restricted Stock Units and Performance Stock Unit | 9 Months Ended |
Sep. 30, 2022 $ / shares shares | |
RSU and PSU Roll Forward Activity | |
Unvested shares, beginning balance (in shares) | shares | 623,000 |
Stock options granted (in shares) | shares | 328,150 |
Vested (in shares) | shares | (132,854) |
Forfeited (in shares) | shares | (64,940) |
Unvested shares, ending balance (in shares) | shares | 753,356 |
Weighted-Average | |
Weighted average grant-date fair value of options beginning balance (in USD per share) | $ / shares | $ 8.63 |
Weighted-average grant date fair value of employee stock award grants (in USD per share) | $ / shares | 5.37 |
Weighted average grant-date fair value of options vested (in USD per share) | $ / shares | 9.40 |
Weighted average grant-date fair value of options forfeited (in USD per share) | $ / shares | 7.95 |
Weighted average grant-date fair value of options ending balance (in USD per share) | $ / shares | $ 7.13 |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Non-cash Stock Based Compensation Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total stock-based compensation expense | $ 2,222 | $ 2,330 | $ 6,477 | $ 5,937 |
Research and development | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total stock-based compensation expense | 856 | 686 | 2,301 | 1,627 |
Selling, general and administrative | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total stock-based compensation expense | $ 1,366 | $ 1,644 | $ 4,176 | $ 4,310 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Income Tax Disclosure [Abstract] | ||||
Provision for income taxes | $ 0 | $ 16,000 | $ 26,000 | $ 46,000 |
Effective tax rate | (0.04%) | (0.30%) |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) | 3 Months Ended | 9 Months Ended | ||||
Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Dec. 31, 2021 | Oct. 31, 2017 USD ($) ft² | |
Other Commitments [Line Items] | ||||||
Rent expense recognized for company's operating leases | $ 100,000 | $ 100,000 | $ 400,000 | $ 400,000 | ||
Variable lease payments for operating leases | $ 23,000 | $ 23,000 | 100,000 | 100,000 | ||
Operating cash outflows for operating lease liabilities | $ 500,000 | $ 500,000 | ||||
Weighted-average remaining lease term (in years) | 6 months | 6 months | 1 year 2 months 12 days | |||
Weighted-average discount rate (in percent) | 9.15% | 9.15% | 9.15% | |||
Palo Alto, California | ||||||
Other Commitments [Line Items] | ||||||
Total leased space | ft² | 8,029 | |||||
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 | Sep. 30, 2022 | Dec. 31, 2021 |
Leases [Abstract] | ||
Remaining in 2022 | $ 167 | |
2023 | 115 | |
2024 | 1 | |
2025 | 1 | |
Total undiscounted payments | 284 | |
Less: imputed interest | 5 | |
Present value of future lease payments | 279 | |
Less: current portion of operating lease liabilities | 277 | $ 628 |
Operating lease liabilities | $ 2 | $ 116 |
Net Loss Per Share - Summary of
Net Loss Per Share - Summary of Potentially Dilutive Shares Excluded from Computation of Diluted Net (Loss) Income Per Share (Details) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Anti-dilutive securities | 7,715,145 | 6,041,611 | 7,715,145 | 6,042,589 |
Options to purchase common stock | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Anti-dilutive securities | 6,876,679 | 5,378,092 | 6,876,679 | 5,378,092 |
Restricted stock units (unvested) | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Anti-dilutive securities | 753,356 | 627,088 | 753,356 | 627,088 |
ESPP | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Anti-dilutive securities | 85,110 | 36,431 | 85,110 | 37,409 |