Cover
Cover - shares | 6 Months Ended | |
Jun. 30, 2023 | Aug. 09, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2023 | |
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 $0.001 per share) | |
Trading Symbol | EIGR | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 44,296,417 | |
Amendment Flag | false | |
Document Fiscal Period Focus | Q2 | |
Entity Central Index Key | 0001305253 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2023 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 22,983 | $ 25,798 |
Short-term debt securities | 30,626 | 73,150 |
Accounts receivable, net | 3,715 | 1,749 |
Inventories | 1,098 | 2,853 |
Prepaid expenses and other current assets | 12,062 | 13,985 |
Total current assets | 70,484 | 117,535 |
Property and equipment, net | 755 | 696 |
Operating lease right-of-use assets | 329 | 561 |
Other assets | 790 | 1,347 |
Total assets | 72,358 | 120,139 |
Current liabilities: | ||
Accounts payable | 4,946 | 8,975 |
Accrued liabilities | 11,446 | 15,655 |
Current portion of operating lease liabilities | 321 | 491 |
Total current liabilities | 16,713 | 25,121 |
Debt | 40,349 | 39,625 |
Operating lease liabilities | 1 | 83 |
Total liabilities | 57,063 | 64,829 |
Stockholders’ equity: | ||
Common stock | 44 | 44 |
Additional paid-in capital | 496,087 | 492,759 |
Accumulated other comprehensive loss | (164) | (300) |
Accumulated deficit | (480,672) | (437,193) |
Total stockholders’ equity | 15,295 | 55,310 |
Total liabilities and stockholders’ equity | $ 72,358 | $ 120,139 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Revenues [Abstract] | ||||
Product revenue, net | $ 4,643,000 | $ 4,091,000 | $ 8,761,000 | $ 6,764,000 |
Costs and operating expenses: | ||||
Cost of sales | 151,000 | 261,000 | ||
Cost of sales | (310,000) | (192,000) | ||
Research and development | 19,401,000 | 16,993,000 | 36,149,000 | 34,563,000 |
Selling, general and administrative | 5,533,000 | 7,027,000 | 15,048,000 | 13,840,000 |
Total costs and operating expenses | 24,624,000 | 24,171,000 | 51,005,000 | 48,664,000 |
Loss from operations | (19,981,000) | (20,080,000) | (42,244,000) | (41,900,000) |
Interest expense | (1,343,000) | (934,000) | (2,628,000) | (1,820,000) |
Interest income | 660,000 | 221,000 | 1,371,000 | 266,000 |
Other (expense) income, net | (29,000) | (1,074,000) | 26,000 | (1,047,000) |
Loss before provision for income taxes | (20,693,000) | (21,867,000) | (43,475,000) | (44,501,000) |
Provision for income taxes | 2,000 | 17,000 | 4,000 | 26,000 |
Net loss | $ (20,695,000) | $ (21,884,000) | $ (43,479,000) | $ (44,527,000) |
Net loss per common share: | ||||
Basic (in USD per share) | $ (0.47) | $ (0.51) | $ (0.98) | $ (1.14) |
Diluted (in USD per share) | $ (0.47) | $ (0.51) | $ (0.98) | $ (1.14) |
Weighted-average common shares outstanding: | ||||
Basic (in shares) | 44,296,417 | 43,059,809 | 44,221,442 | 39,178,043 |
Diluted (in shares) | 44,296,417 | 43,059,809 | 44,221,442 | 39,178,043 |
Product revenue, net | ||||
Revenues [Abstract] | ||||
Product revenue, net | $ 4,393,000 | $ 3,341,000 | $ 8,511,000 | $ 6,014,000 |
Other revenue | ||||
Revenues [Abstract] | ||||
Product revenue, net | $ 250,000 | $ 750,000 | $ 250,000 | $ 750,000 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Statement of Comprehensive Income [Abstract] | ||||
Net loss | $ (20,695) | $ (21,884) | $ (43,479) | $ (44,527) |
Other comprehensive loss: | ||||
Unrealized (loss) gain on available-for-sale debt securities, net | (7) | (239) | 160 | (612) |
Foreign currency translation adjustment | 13 | 0 | (24) | 0 |
Comprehensive loss | $ (20,689) | $ (22,123) | $ (43,343) | $ (45,139) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders’ Equity (Unaudited) - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive (Loss) | Accumulated Deficit |
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 | ||||
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] | |||||
Unrealized gain/(loss) on available-for-sale debt securities, net | (612) | ||||
Cumulative translation adjustment | 0 | ||||
Net loss | (44,527) | ||||
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) |
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 upon exercise of stock options (in shares) | 1,604 | ||||
Issuance of common stock upon exercise of stock options | 9 | 9 | |||
Issuance of common stock to lender (in shares) | 749,053 | ||||
Issuance of common stock to lender | 5,000 | $ 1 | 4,999 | ||
Stock-based compensation expense | 2,208 | 2,208 | |||
Unrealized gain/(loss) on available-for-sale debt securities, net | (239) | (239) | |||
Cumulative translation adjustment | 0 | ||||
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) |
Balance, beginning of period (in shares) at Dec. 31, 2022 | 44,074,284 | ||||
Balance, beginning of period at Dec. 31, 2022 | 55,310 | $ 44 | 492,759 | (300) | (437,193) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock upon ESPP purchase (in shares) | 29,986 | ||||
Issuance of common stock upon ESPP purchase | 41 | 41 | |||
Issuance of common stock upon release of restricted stock units (in shares) | 192,147 | ||||
Stock-based compensation expense | 2,542 | 2,542 | |||
Unrealized gain/(loss) on available-for-sale debt securities, net | 167 | 167 | |||
Cumulative translation adjustment | (37) | (37) | |||
Net loss | (22,784) | (22,784) | |||
Balance, end of period (in shares) at Mar. 31, 2023 | 44,296,417 | ||||
Balance, end of period at Mar. 31, 2023 | 35,239 | $ 44 | 495,342 | (170) | (459,977) |
Balance, beginning of period (in shares) at Dec. 31, 2022 | 44,074,284 | ||||
Balance, beginning of period at Dec. 31, 2022 | 55,310 | $ 44 | 492,759 | (300) | (437,193) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Unrealized gain/(loss) on available-for-sale debt securities, net | 160 | ||||
Cumulative translation adjustment | (24) | ||||
Net loss | (43,479) | ||||
Balance, end of period (in shares) at Jun. 30, 2023 | 44,296,417 | ||||
Balance, end of period at Jun. 30, 2023 | 15,295 | $ 44 | 496,087 | (164) | (480,672) |
Balance, beginning of period (in shares) at Mar. 31, 2023 | 44,296,417 | ||||
Balance, beginning of period at Mar. 31, 2023 | 35,239 | $ 44 | 495,342 | (170) | (459,977) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Stock-based compensation expense | 745 | 745 | |||
Unrealized gain/(loss) on available-for-sale debt securities, net | (7) | (7) | |||
Cumulative translation adjustment | 13 | 13 | |||
Net loss | (20,695) | (20,695) | |||
Balance, end of period (in shares) at Jun. 30, 2023 | 44,296,417 | ||||
Balance, end of period at Jun. 30, 2023 | $ 15,295 | $ 44 | $ 496,087 | $ (164) | $ (480,672) |
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 | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Operating activities | ||
Net loss | $ (43,479) | $ (44,527) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 140 | 146 |
Inventory write down | 10 | 0 |
Amortization of debt securities premiums and discounts | (778) | 564 |
Loss on extinguishment of debt | 0 | 1,144 |
Non-cash interest expense | 724 | 468 |
Reduction in the carrying amount of right-of-use assets | 232 | 268 |
Common stock issued under Product Development Agreement | 0 | 19 |
Stock-based compensation | 3,287 | 4,255 |
Change in operating assets and liabilities: | ||
Accounts receivable | (1,959) | 1,538 |
Inventories | 3,171 | (330) |
Prepaid expenses and other current assets | 1,370 | (2,636) |
Other assets | 1,110 | (568) |
Accounts payable | (3,955) | 1,899 |
Accrued liabilities | (5,661) | (2,138) |
Operating lease liabilities | (252) | (305) |
Net cash used in operating activities | (46,040) | (40,203) |
Investing activities | ||
Purchase of debt securities available-for-sale | (19,388) | (45,779) |
Proceeds from maturities of debt securities available-for-sale | 62,850 | 23,239 |
Purchase of property and equipment | (233) | (9) |
Net cash provided by (used in) investing activities | 43,229 | (22,549) |
Financing activities | ||
Issuance of common stock upon offering at-the-market, net of commissions | 0 | 66,402 |
Proceeds from issuance of common stock to lender | 0 | 5,000 |
Proceeds from issuance of common stock upon stock option exercises | 0 | 153 |
Proceeds from issuance of common stock upon ESPP purchase | 41 | 64 |
Proceeds from debt | 0 | 39,840 |
Repayment of debt | 0 | (33,277) |
Payment of debt issuance costs | 0 | (835) |
Common stock offering costs | (22) | (244) |
Net cash provided by financing activities | 19 | 77,103 |
Effect of foreign exchange on cash and cash equivalents | (23) | 0 |
Net (decrease) increase in cash and cash equivalents | (2,815) | 14,351 |
Cash and cash equivalents at beginning of period | 25,798 | 22,221 |
Cash and cash equivalents at end of period | 22,983 | 36,572 |
Supplemental disclosure of cash flow information: | ||
Interest paid | 1,903 | 1,395 |
Income taxes paid | 148 | 152 |
Purchases of property and equipment in accounts payable and accrued liabilities | $ 0 | $ 49 |
Description of Business
Description of Business | 6 Months Ended |
Jun. 30, 2023 | |
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 rare metabolic diseases. Eiger’s lead product candidate, avexitide, is a well characterized, first-in-class glucagon-like peptide-1 ( GLP-1) antagonist and is in development for the treatment of post-bariatric hypoglycemia (PBH) and other form of hyperinsulinemic hypoglycemia (HH) arising after gastrointestinal surgeries. These disorders are characterized by exaggerated secretion of GLP-1 after meals, dysregulated secretion of insulin, and a rapid drop in blood sugar. Avexitide is the only drug in development for PBH with Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA). Avexitide is also in development for congenital hyperinsulinism (HI), an ultra-rare, life-threatening, pediatric disorder of persistent hypoglycemia that results in irreversible brain damage in up to 50% of children with the condition. Avexitide has completed Phase 2 for both PBH and HI, and Phase 3 study startup activities for PBH and for HI have been initiated. 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), with either heterozygous LMNA mutation with progerin-like protein accumulation, or homozygous or compound heterozygous ZMPSTE24 mutations, on November 20, 2020. Collectively known as progeria, HGPS and PL are ultra-rare, fatal, genetic premature aging diseases that accelerate mortality in young patients. In July 2022, the Company announced that the European Commission (EC) granted Eiger a centralized marketing authorization (MA) under the exceptional circumstances procedure for Zokinvy. The EC's centralized MA is valid in all 27 European Union (EU) member states plus Iceland, Liechtenstein, and Norway. In August 2022, the Medicine and Healthcare products Regulatory Agency (MHRA) granted approval in the UK. The Company commercially launched Zokinvy in the U.S. in January 2021 and started to record product revenue in the first quarter of 2021. The first European sales were recognized in the fourth quarter of 2022. In June 2023, the Company announced that it is focusing its clinical development efforts on advancing avexitide in HH indications, including PBH. The Company will continue to commercialize Zokinvy (lonafarnib) for the treatment of HGPS and processing-deficient PL. In addition, Eiger is evaluating strategic partnering options for its virology assets, lonafarnib and peginterferon lambda. In June 2023, the Company also announced that it has appointed David Apelian, MD, PhD, MBA, who has served as interim Chief Executive Officer (CEO) since December 2022, as the Company's next CEO. The Company’s principal operations are based in Palo Alto, California, with subsidiaries in Delaware, Ireland, England and Wales. The Company operates in one segment. Liquidity As of June 30, 2023, the Company had $53.6 million of cash, cash equivalents and short-term securities, comprised of $23.0 million of cash and cash equivalents and $30.6 million of short-term debt securities available-for-sale. The Company had an accumulated deficit of $480.7 million and negative cash flows from operating activities as of June 30, 2023. 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, including by potentially drawing the $17.5 million available under Tranche B under Innovatus Term Loan. 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. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Basis of Presentation The 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 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. Concentrations of Risk Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash, cash equivalents and investments. The Company’s cash is held by financial institutions in the United States and Ireland. Amounts on deposit may at times exceed federally insured limits. Management believes that the financial institutions are financially sound, and accordingly, minimal credit risk exists with respect to the financial institutions. The Company relies on one supply chain for each of its product candidates. If any of the single source suppliers in any of the supply chains fail to satisfy the Company’s requirements on a timely basis, it could suffer delays in its clinical development programs and activities which could adversely affect its operating results. Two customers accounted for approximately 63 percent and 37 percent of the Company’s accounts receivable as of June 30, 2023. Two customers accounted for approximately 58 percent and 42 percent of the Company’s accounts receivable as of December 31, 2022. Two customers accounted for approximately 78 percent and 22 percent of product revenue during the three months ended June 30, 2023. Two customers accounted for approximately 77 percent and 23 percent of product revenue during the six months ended June 30, 2023. One customer accounted for approximately 99 percent and 100 percent of product revenue during the three and six months ended June 30, 2022. Three vendors accounted for approximately 43 percent, 12 percent and 11 percent of the Company's accounts payable as of June 30, 2023. Two vendors accounted for approximately 12 percent and 11 percent of the Company's accounts payable as of December 31, 2022. Foreign Currency Exchange Foreign Currency Transaction Risk The foreign currency transaction risk relates to changes in exchange rates on monetary assets, liabilities, revenues and expenses held at Eiger BioPharmaceuticals Europe Limited . Gains and losses on foreign currency transactions result primarily from monetary assets, liabilities, revenues and expenses denominated in Euro. Aggregated transaction gains for the six months ended June 30, 2023 was $26,000 and the aggregated transaction loss for the three months ended June 30, 2023 was $29,000. The Company expects the foreign currency gain/loss to continue to fluctuate as long as the Company continue to hold monetary assets and liabilities at its subsidiaries in Ireland and England and Wales. Market uncertainty could potentially lead to significant volatility with foreign currency exchange rates, which could result in additional foreign currency gain/loss. Foreign Currency Translation Risk The foreign currency translation risk relates to the translation of the foreign consolidated subsidiaries' assets, liabilities, revenues and expenses from the subsidiaries’ functional currency to the U.S. dollar at each reporting date. Fluctuations in exchange rates may impact the amount of assets, liabilities, revenues and expenses reported on the consolidated balance sheets and consolidated statements of operations. The financial statements of the Company’s foreign subsidiaries, which have a functional currency other than the U.S. dollar, are translated into U.S. dollars using a current exchange rate. Gains and losses resulting from this translation are recognized as a foreign currency translation adjustment within accumulated other comprehensive loss, which is a component of stockholders' equity and comprehensive income (loss). Aggregate translation gain, net of tax, was $13,000 and $0 for the three months ended June 30, 2023 and 2022, respectively, and aggregated translation loss, net of tax was $24,000 and $0 for the six months ended June 30, 2023 and 2022, respectively. Debt Securities All securities are short-term in nature and 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. 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. The Company evaluates, on a quarterly basis, its available-for-sale debt securities for potential impairment. For available-for-sale debt securities in an unrealized loss position, the Company assesses whether such declines are due to credit related factors such as changes to the rating of the security by a ratings agency, market conditions and supportable forecasts of economic and market conditions, among others. If the fair value of available-for-sale debt securities is less than the amortized cost basis, the Company assesses whether it has plans to sell the security or it is more likely than not it will be required to sell any available-for-sale debt security before recovery of its amortized cost basis. If either condition is met, the security’s amortized cost basis is written down to fair value and is recognized through other (expense) income, net. If neither condition is met, declines as a result of credit losses, if any, are recognized as an allowance for credit loss, limited to the amount of unrealized loss, through other (expense) income, net. Any portion of the unrealized loss that is not a result of a credit loss, is recognized in other comprehensive loss. 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. Accounts Receivable Accounts receivable represent amounts billed to the Company’s customers, net of an allowance for credit losses. Trade accounts receivable are recorded at invoiced amounts and do not bear interest. The allowance for credit losses reflects the Company’s best estimate of probable losses inherent in the receivable portfolio determined based on various factors, including age of the outstanding invoice, credit quality of the customer, historical experience, current economic conditions, and management’s expectations of future economic conditions. The Company regularly reviews the adequacy of the allowance for credit losses by considering the age of each outstanding invoice and the collection history of each customer to determine the appropriate amount of allowance for credit losses. The Company had no allowance for credit losses as of June 30, 2023 and December 31, 2022. The Company had no credit losses for the periods presented. 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 write downs of inventory were immaterial for the three and six months ended June 30, 2023 and 2022. 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, EC centralized MA in July 2022, and MHRA approval in August 2022. Zokinvy was launched commercially in the United States in January 2021 and in Europe in November 2022. 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 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 a one year extension through September 2024 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 through a reimbursed early access program in France. The Company recorded revenue of $0.1 million and $0.6 million from sales of product under the ATU program for the three and six months ended June 30, 2023, respectively. The revenue from sales of product under the ATU program was immaterial for the three and six months ended June 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 and in Europe. 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 and commercial 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 condensed consolidated balance sheets and within research and development expenses in the accompanying 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 Adopted Accounting Pronouncements In June 2016, the Financial Accounting Standards Board (FASB) issued Accounting Standards Updates (ASU) No. 2016-13, Financial Instruments—Credit Losses (Topic 326) . ASU 2016-13 requires an entity to utilize a new impairment model that requires measurement and recognition of expected credit losses for most financial assets and certain other instruments, including but not limited to available-for-sale debt securities. Credit losses relating to available-for-sale debt securities will be recorded through an allowance for credit losses rather than as a direct write-down to the security. The new guidance requires the use of forward-looking expected credit loss models based on historical experience, current conditions, and reasonable and supportable forecasts that affect the collectability of the reported amount, which may result in earlier recognition of credit losses under the new guidance. 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 |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value Measurements Fair value accounting is applied for all financial assets and liabilities that are recognized or disclosed at fair value in the financial statements on a recurring basis (at least annually). As of June 30, 2023 and December 31, 2022, the carrying amount of cash equivalents, 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 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 and commercial paper 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 June 30, 2023 and December 31, 2022. 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, and summarize the estimated value of the Company’s cash equivalents and debt securities and the gross unrealized holding gains and losses (in thousands): June 30, 2023 Level Amortized cost Unrealized gain Unrealized loss Estimated Fair Cash equivalents: Money market funds 1 $ 20,297 $ — $ — $ 20,297 Total cash equivalents $ 20,297 $ — $ — $ 20,297 Debt securities: Corporate debt securities 2 $ 3,998 $ — $ (1) $ 3,997 U.S. government bonds 2 26,668 — (39) 26,629 Total debt securities $ 30,666 $ — $ (40) $ 30,626 Classified as: Cash equivalents 1 $ 20,297 Short-term debt securities 2 30,626 $ 50,923 December 31, 2022 Level Amortized cost Unrealized gain Unrealized loss Estimated Fair Cash equivalents: Money market funds 1 $ 11,546 $ — $ — $ 11,546 Commercial paper 2 3,968 — — 3,968 Total cash equivalents $ 15,514 $ — $ — $ 15,514 Debt securities: U.S. government bonds 2 $ 39,646 $ 3 $ (86) $ 39,563 Corporate debt securities 2 28,759 — (117) 28,642 Commercial paper 2 4,945 — — 4,945 Total debt securities $ 73,350 $ 3 $ (203) $ 73,150 Classified as: Cash equivalents 1 & 2 $ 15,514 Short-term debt securities 2 73,150 $ 88,664 There were no financial liabilities as of June 30, 2023 and December 31, 2022. During the three and six months ended June 30, 2023, the Company did not recognize any other-than-temporary impairment losses. The Company determined that the decline in fair value of debt securities was not due to credit-related factors, and no allowance for expected credit losses was recorded as of June 30, 2023 . |
Balance Sheet Components
Balance Sheet Components | 6 Months Ended |
Jun. 30, 2023 | |
Balance Sheet Related Disclosures [Abstract] | |
Balance Sheet Components | Balance Sheet Components Inventories Inventories consist of the following (in thousands): June 30, December 31, Raw materials $ 279 $ 1,703 Work-in-progress 628 884 Finished goods 191 266 Total inventories $ 1,098 $ 2,853 Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consist of the following (in thousands): June 30, December 31, Prepaid contract manufacturing costs $ 1,572 $ 3,542 Short term deposits 4,732 4,542 Prepaid research costs 3,355 2,822 Prepaid insurance 926 586 Prepaid marketing 343 753 Other 1,134 1,740 Total prepaid expenses and other current assets $ 12,062 $ 13,985 Accrued Liabilities Accrued liabilities consist of the following (in thousands): June 30, December 31, Compensation and related benefits $ 3,925 $ 6,167 Contract research costs 1,559 4,188 Contract manufacturing costs 2,016 2,101 Product revenue reserves 1,831 1,373 Data hosting services 1,089 10 Legal fees 702 562 Other 324 1,254 Total accrued liabilities $ 11,446 $ 15,655 |
Bristol-Meyers Squibb License A
Bristol-Meyers Squibb License Agreement | 6 Months Ended |
Jun. 30, 2023 | |
Product Development Agreement [Abstract] | |
Bristol-Meyers Squibb License Agreement | Bristol-Meyers Squibb License AgreementOn 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 and development, which was related to the initiation of a Phase 3 clinical trial, as defined under the BMS License Agreement. |
Debt
Debt | 6 Months Ended |
Jun. 30, 2023 | |
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, including failure to pay amounts due, breaches of covenants and warranties, material adverse change events, certain cross defaults and judgements, and insolvency, 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 Company believes it is in compliance with the terms included with the Innovatus Loan. 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 is currently eligible to draw the $17.5 million under Tranche B, but has not done so as of June 30, 2023. 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 $1.1 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 six months ended June 30, 2023 was $1.3 million and $2.6 million, respectively, and is inclusive of non-cash amortization of the debt discount and debt issuance costs and accretion of final payment. The carrying amount of the Innovatus Loan approximates fair value. The effective interest rate for the Innovatus Loan was 13.60% as of June 30, 2023. 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 (the Oxford Loan) by the Company. Oxford Term Loan 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. 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): June 30, December 31, Face value of debt $ 40,985 $ 40,531 Exit fee 2,600 2,600 Unamortized debt discount associated with exit fee, debt issuance costs and loan origination fees (3,236) (3,506) Total debt, net $ 40,349 $ 39,625 |
Stock-Based Compensation
Stock-Based Compensation | 6 Months Ended |
Jun. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | Stock-Based CompensationIn June 2016, the Company’s Board of Directors adopted and in August 2016 the Company’s stockholders approved the Amended and Restated 2013 Equity Incentive Plan (Restated 2013 Plan). As of June 30, 2023, there were 3,134,441 shares available for grant under the Restated 2013 Plan. During the second quarter of 2021, the Company approved the 2021 Inducement Plan 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 June 30, 2023, there were 1,495,000 shares remaining and available to be issued under the 2021 Inducement Plan. The following table summarizes stock option activity under the Company’s stock-based compensation plans during the six months ended June 30, 2023 (in thousands, except option and share data): Number of Weighted- Weighted- Aggregate Outstanding as of December 31, 2022 6,143,183 $ 9.00 6.00 $ — Granted 2,461,278 $ 1.44 Forfeited (1,267,693) $ 5.34 Outstanding as of June 30, 2023 7,336,768 $ 7.26 5.16 $ — Vested and exercisable as of June 30, 2023 4,606,523 $ 9.41 3.47 $ — During the three and six months ended June 30, 2023, the weighted-average grant date fair value of options granted were $1.03 and $1.44 per share, respectively. During the three and six months ended June 30, 2022, the weighted-average grant date fair value of options granted were $4.39 and $3.53 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 June 30, Six Months Ended June 30, 2023 2022 2023 2022 Expected term (in years) 6.02 6.08 5.15-6.08 5.27-6.08 Volatility 91.26%-92.98% 70.15%-71.20% 90.21%-93.48% 68.71%-71.20% Risk free interest rate 3.50%-4.05% 2.84%-3.03% 3.50%-4.22% 1.76%-3.03% Dividend yield — — — — Restricted Stock Units and Performance Stock Units There were no performance stock units (PSUs) granted during the three months ended June 30, 2023. During the six months ended June 30, 2023, the Company granted 15,000 PSUs, with a weighted-average grant date fair value of $2.26 per share. During the three and six months ended June 30, 2022, the Company granted 30,000 PSUs with a weighted-average grant date fair value of $6.87 per share for both periods. The performance-based metrics include the achievement of certain revenue targets and clinical and regulatory milestones. During the three and six months ended June 30, 2023, the Company recorded $0.1 million and $0.2 million, respectively, of stock-based compensation expense related to the PSUs as it was expected at the beginning of the period that all milestones would be achieved by the target dates. This expense is included in selling, general and administrative expenses. On June 30, 2023, the Company reassessed the probability of the performance-based metrics being achieved. The Company concluded that the performance-based metrics are no longer probable of being achieved but are still more than improbable. As such, the Company will discontinue recognizing expense related to the PSUs on a prospective basis and will not reverse the previously recognized expenses. In May 2023, four employees were terminated who had outstanding PSU awards. As the performance-based metrics were not achieved at time of termination, the stock compensation expense related to these awards of $0.4 million was reversed. During the three and six months ended June 30, 2022, there were no PSUs vested as the performance-based metrics of the PSUs had not yet been achieved. As of June 30, 2023, other than 15,000 PSUs for which vesting was accelerated in connection with the modification noted below, no PSUs have vested as the performance-based metrics of the PSUs have not yet been achieved. There were no restricted stock units (RSUs) granted during the three months ended June 30, 2023 and 2022. During the six months ended June 30, 2023 and 2022, the Company granted 39,167 and 298,150 RSUs, respectively, with a weighted-average grant date fair value of $2.26 and $5.22 per share, respectively. In relation to the RSUs granted, the Company recognized $0.1 million and $0.5 million in stock-based compensation expense for the three months ended June 30, 2023 and 2022, respectively, and $0.5 million and $0.9 million in stock-based compensation expense for the six months ended June 30, 2023 and 2022, respectively, which were included in selling, general and administrative expenses. As of June 30, 2023, the total unrecognized compensation expense related to unvested RSUs and PSUs was $1.4 million, which the Company expects to recognize over an estimated weighted-average period of 1.7 years. The following table summarizes RSU and PSU activity and weighted average grant date fair value for the six months ended June 30, 2023: Shares Weighted- Unvested shares as of December 31, 2022 641,407 $ 7.08 Granted 54,167 $ 2.26 Vested (192,147) $ 5.12 Forfeited (202,019) $ 7.23 Unvested shares as of June 30, 2023 301,408 $ 7.36 Awards Modification On February 6, 2023, the Company entered into a separation agreement and general release with David Cory, the Company's former President and CEO. Pursuant to the separation agreement, 50% of Mr. Cory's unvested equity awards were accelerated to vest on the date the separation agreement was executed. Additionally, the exercise period for Mr. Cory's vested awards was extended, including his accelerated awards. The stock compensation recognized related to these modifications was $0 and $0.9 million for the three and six months ended June 30, 2023, which is reflected in selling, general and administrative expenses. Stock-Based Compensation Expense Total stock-based compensation expense recognized was as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2023 2022 2023 2022 Research and development $ 517 $ 820 $ 1,351 $ 1,445 Selling, general and administrative 228 1,388 1,936 2,810 Total $ 745 $ 2,208 $ 3,287 $ 4,255 As of June 30, 2023, the total unrecognized compensation expense related to unvested options was $6.1 million, which the Company expects to recognize over an estimated weighted average period of 2.8 years. |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income TaxesThe Company’s provision for income taxes was approximately $2,000 and $4,000 for the three and six months ended June 30, 2023, respectively, with an effective tax rate of (0.01)% for the six months ended June 30, 2023. The Company’s provision for income taxes was approximately $17,000 and $26,000 for the three and six months ended June 30, 2022, respectively, with an effective tax rate of (0.06)% for the six months ended June 30, 2022. The effective tax rate in each period differs from the U.S. statutory tax rate primarily due to the valuation allowances on the Company’s deferred tax assets as it is more likely than not that some or all of the Company’s deferred tax assets will not be realized. The tax expense recorded for the three and six months ended June 30, 2023 relates to state taxes. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2023 | |
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 Boulevard in Palo Alto, California. The lease commenced on March 1, 2018 and was to expire in February 2023. The lease had a three-year renewal option prior to expiration. The lease included rent escalation clauses throughout the lease term. In October 2017, the Company provided a security deposit of $0.3 million. In February 2023, the Company amended the lease to extend the lease by one year with a one year renewal option. The extended lease commenced on March 1, 2023 and expires on February 28, 2024. The Company accounted for the amendment as a lease modification in accordance with ASC Topic 842. The Company also has additional operating leases that are included in its lease accounting but are not considered material for disclosure. The maturities of the Company’s operating lease liabilities as of June 30, 2023 were as follows (in thousands): Undiscounted lease payments June 30, 2023 Remaining in 2023 $ 249 2024 84 2025 1 Total undiscounted payments 334 Less: imputed interest 12 Present value of future lease payments 322 Less: current portion of operating lease liabilities 321 Operating lease liabilities $ 1 Rent expense recognized for the Company’s operating leases was $0.1 million for the three months ended June 30, 2023 and 2022, and $0.3 million for the six months ended June 30, 2023 and 2022. 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 June 30, 2023 and 2022, and $38,000 and $46,000 for the six months ended June 30, 2023 and 2022, respectively. The operating cash outflows for the operating lease liabilities were $0.3 million for the six months ended June 30, 2023 and 2022. As of June 30, 2023 and December 31, 2022, the weighted-average remaining lease terms were 0.7 years and 1.2 years, and weighted-average discount rates were 12.82% and 12.82%, respectively. Legal Matters Schoen v. Eiger BioPharmaceuticals, Inc., et al. , Case No. 22-cv-06985 On November 8, 2022 a putative securities class action complaint was filed in the United States District Court for the Northern District of California alleging that the company and two former executives violated Sections 10(b) and 20(a) of the Securities Exchange Act and SEC Rule 10b-5. The complaint alleged generally that between March 2021 and October 2022, material misstatements and omissions were made to shareholders regarding the TOGETHER study of peginterferon lambda for the treatment of COVID-19 as well as the likelihood of FDA approval of an Emergency Use Authorization for peginterferon lambda. The Court appointed a lead plaintiff on March 2, 2023. On April 10, 2023, the lead plaintiff filed a notice of voluntary dismissal without prejudice. The Progeria Research Foundation, Inc. v. Eiger BioPharmaceuticals, Inc. Arbitration On November 15, 2022, the Company received a demand for arbitration (Demand) from claimant The Progeria Research Foundation, Inc. (PRF) asserting two claims under a May 15, 2018 Collaboration and Supply Agreement (the PRF Collaboration Agreement) between the parties. PRF has alleged that the Company breached an obligation to supply quantities of a drug as requested by PRF. PRF also has a claim for declaratory relief regarding the grant of licenses under the PRF Collaboration Agreement. On January 18, 2023, the Company filed a response to the Demand denying PRF’s claims, contesting the arbitrability of PRF’s claim for declaratory relief, and asserting a counterclaim for declaratory relief related to the contractual provision underlying PRF’s original drug supply claim. To give the parties an opportunity to discuss a potential negotiated resolution of their dispute, the arbitration has been suspended through the end of 2023. As a |
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 Boulevard in Palo Alto, California. The lease commenced on March 1, 2018 and was to expire in February 2023. The lease had a three-year renewal option prior to expiration. The lease included rent escalation clauses throughout the lease term. In October 2017, the Company provided a security deposit of $0.3 million. In February 2023, the Company amended the lease to extend the lease by one year with a one year renewal option. The extended lease commenced on March 1, 2023 and expires on February 28, 2024. The Company accounted for the amendment as a lease modification in accordance with ASC Topic 842. The Company also has additional operating leases that are included in its lease accounting but are not considered material for disclosure. The maturities of the Company’s operating lease liabilities as of June 30, 2023 were as follows (in thousands): Undiscounted lease payments June 30, 2023 Remaining in 2023 $ 249 2024 84 2025 1 Total undiscounted payments 334 Less: imputed interest 12 Present value of future lease payments 322 Less: current portion of operating lease liabilities 321 Operating lease liabilities $ 1 Rent expense recognized for the Company’s operating leases was $0.1 million for the three months ended June 30, 2023 and 2022, and $0.3 million for the six months ended June 30, 2023 and 2022. 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 June 30, 2023 and 2022, and $38,000 and $46,000 for the six months ended June 30, 2023 and 2022, respectively. The operating cash outflows for the operating lease liabilities were $0.3 million for the six months ended June 30, 2023 and 2022. As of June 30, 2023 and December 31, 2022, the weighted-average remaining lease terms were 0.7 years and 1.2 years, and weighted-average discount rates were 12.82% and 12.82%, respectively. Legal Matters Schoen v. Eiger BioPharmaceuticals, Inc., et al. , Case No. 22-cv-06985 On November 8, 2022 a putative securities class action complaint was filed in the United States District Court for the Northern District of California alleging that the company and two former executives violated Sections 10(b) and 20(a) of the Securities Exchange Act and SEC Rule 10b-5. The complaint alleged generally that between March 2021 and October 2022, material misstatements and omissions were made to shareholders regarding the TOGETHER study of peginterferon lambda for the treatment of COVID-19 as well as the likelihood of FDA approval of an Emergency Use Authorization for peginterferon lambda. The Court appointed a lead plaintiff on March 2, 2023. On April 10, 2023, the lead plaintiff filed a notice of voluntary dismissal without prejudice. The Progeria Research Foundation, Inc. v. Eiger BioPharmaceuticals, Inc. Arbitration On November 15, 2022, the Company received a demand for arbitration (Demand) from claimant The Progeria Research Foundation, Inc. (PRF) asserting two claims under a May 15, 2018 Collaboration and Supply Agreement (the PRF Collaboration Agreement) between the parties. PRF has alleged that the Company breached an obligation to supply quantities of a drug as requested by PRF. PRF also has a claim for declaratory relief regarding the grant of licenses under the PRF Collaboration Agreement. On January 18, 2023, the Company filed a response to the Demand denying PRF’s claims, contesting the arbitrability of PRF’s claim for declaratory relief, and asserting a counterclaim for declaratory relief related to the contractual provision underlying PRF’s original drug supply claim. To give the parties an opportunity to discuss a potential negotiated resolution of their dispute, the arbitration has been suspended through the end of 2023. As a |
Net Loss Per Share
Net Loss Per Share | 6 Months Ended |
Jun. 30, 2023 | |
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 and six months ended June 30, 2023 and 2022, diluted net loss per share is the same as basic net loss per share as the inclusion of all potential common shares outstanding would have been anti-dilutive. 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 Six Months Ended 2023 2022 2023 2022 Options to purchase common stock 7,336,768 6,892,009 7,336,768 6,892,009 Restricted and Performance stock units (unvested) 301,408 818,019 301,408 818,019 ESPP 345,352 89,662 345,352 89,662 Total 7,983,528 7,799,690 7,983,528 7,799,690 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Pay vs Performance Disclosure | ||||||
Net loss | $ (20,695) | $ (22,784) | $ (21,884) | $ (22,643) | $ (43,479) | $ (44,527) |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The 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 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. |
Concentrations of Risk | Concentrations of Risk Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash, cash equivalents and investments. The Company’s cash is held by financial institutions in the United States and Ireland. Amounts on deposit may at times exceed federally insured limits. Management believes that the financial institutions are financially sound, and accordingly, minimal credit risk exists with respect to the financial institutions. The Company relies on one supply chain for each of its product candidates. If any of the single source suppliers in any of the supply chains fail to satisfy the Company’s requirements on a timely basis, it could suffer delays in its clinical development programs and activities which could adversely affect its operating results. |
Foreign Currency Exchange | Foreign Currency Exchange Foreign Currency Transaction Risk The foreign currency transaction risk relates to changes in exchange rates on monetary assets, liabilities, revenues and expenses held at Eiger BioPharmaceuticals Europe Limited . Gains and losses on foreign currency transactions result primarily from monetary assets, liabilities, revenues and expenses denominated in Euro. Aggregated transaction gains for the six months ended June 30, 2023 was $26,000 and the aggregated transaction loss for the three months ended June 30, 2023 was $29,000. The Company expects the foreign currency gain/loss to continue to fluctuate as long as the Company continue to hold monetary assets and liabilities at its subsidiaries in Ireland and England and Wales. Market uncertainty could potentially lead to significant volatility with foreign currency exchange rates, which could result in additional foreign currency gain/loss. Foreign Currency Translation Risk The foreign currency translation risk relates to the translation of the foreign consolidated subsidiaries' assets, liabilities, revenues and expenses from the subsidiaries’ functional currency to the U.S. dollar at each reporting date. Fluctuations in exchange rates may impact the amount of assets, liabilities, revenues and expenses reported on the consolidated balance sheets and consolidated statements of operations. The financial statements of the Company’s foreign subsidiaries, which have a functional currency other than the U.S. dollar, are translated into U.S. dollars using a current exchange rate. Gains and losses resulting from this translation are recognized as a foreign currency translation adjustment within accumulated other comprehensive loss, which is a component of stockholders' equity and comprehensive income (loss). Aggregate translation gain, net of tax, was $13,000 and $0 for the three months ended June 30, 2023 and 2022, respectively, and aggregated translation loss, net of tax was $24,000 and $0 for the six months ended June 30, 2023 and 2022, respectively. |
Debt Securities | Debt Securities All securities are short-term in nature and 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. 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. The Company evaluates, on a quarterly basis, its available-for-sale debt securities for potential impairment. For available-for-sale debt securities in an unrealized loss position, the Company assesses whether such declines are due to credit related factors such as changes to the rating of the security by a ratings agency, market conditions and supportable forecasts of economic and market conditions, among others. If the fair value of available-for-sale debt securities is less than the amortized cost basis, the Company assesses whether it has plans to sell the security or it is more likely than not it will be required to sell any available-for-sale debt security before recovery of its amortized cost basis. If either condition is met, the security’s amortized cost basis is written down to fair value and is recognized through other (expense) income, net. If neither condition is met, declines as a result of credit losses, if any, are recognized as an allowance for credit loss, limited to the amount of unrealized loss, through other (expense) income, net. Any portion of the unrealized loss that is not a result of a credit loss, is recognized in other comprehensive loss. 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. |
Accounts Receivable | Accounts Receivable Accounts receivable represent amounts billed to the Company’s customers, net of an allowance for credit losses. Trade accounts receivable are recorded at invoiced amounts and do not bear interest. The allowance for credit losses reflects the Company’s best estimate of probable losses inherent in the receivable portfolio determined based on various factors, including age of the outstanding invoice, credit quality of the customer, historical experience, current economic conditions, and management’s expectations of future economic conditions. The Company regularly reviews the adequacy of the allowance for credit losses by considering the age of each outstanding invoice and the collection history of each customer to determine the appropriate amount of allowance for credit losses. |
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, EC centralized MA in July 2022, and MHRA approval in August 2022. Zokinvy was launched commercially in the United States in January 2021 and in Europe in November 2022. 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 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 a one year extension through September 2024 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 through a reimbursed early access program in France. The Company recorded revenue of $0.1 million and $0.6 million from sales of product under the ATU program for the three and six months ended June 30, 2023, respectively. The revenue from sales of product under the ATU program was immaterial for the three and six months ended June 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 and in Europe. 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 and commercial milestones. |
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 condensed consolidated balance sheets and within research and development expenses in the accompanying 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 Adopted Accounting Pronouncements | Recent Adopted Accounting Pronouncements In June 2016, the Financial Accounting Standards Board (FASB) issued Accounting Standards Updates (ASU) No. 2016-13, Financial Instruments—Credit Losses (Topic 326) . ASU 2016-13 requires an entity to utilize a new impairment model that requires measurement and recognition of expected credit losses for most financial assets and certain other instruments, including but not limited to available-for-sale debt securities. Credit losses relating to available-for-sale debt securities will be recorded through an allowance for credit losses rather than as a direct write-down to the security. The new guidance requires the use of forward-looking expected credit loss models based on historical experience, current conditions, and reasonable and supportable forecasts that affect the collectability of the reported amount, which may result in earlier recognition of credit losses under the new guidance. 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 deferred 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 adopted this guidance on a modified-retrospective basis effective January 1, 2023 and noted no material impact to the Company’s condensed consolidated financial statements. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Summary of Estimated Value of Cash Equivalents and Debt Securities and Gross Unrealized Holding Gains and Losses | The following tables present the fair value hierarchy for assets and liabilities measured at fair value, and summarize the estimated value of the Company’s cash equivalents and debt securities and the gross unrealized holding gains and losses (in thousands): June 30, 2023 Level Amortized cost Unrealized gain Unrealized loss Estimated Fair Cash equivalents: Money market funds 1 $ 20,297 $ — $ — $ 20,297 Total cash equivalents $ 20,297 $ — $ — $ 20,297 Debt securities: Corporate debt securities 2 $ 3,998 $ — $ (1) $ 3,997 U.S. government bonds 2 26,668 — (39) 26,629 Total debt securities $ 30,666 $ — $ (40) $ 30,626 Classified as: Cash equivalents 1 $ 20,297 Short-term debt securities 2 30,626 $ 50,923 December 31, 2022 Level Amortized cost Unrealized gain Unrealized loss Estimated Fair Cash equivalents: Money market funds 1 $ 11,546 $ — $ — $ 11,546 Commercial paper 2 3,968 — — 3,968 Total cash equivalents $ 15,514 $ — $ — $ 15,514 Debt securities: U.S. government bonds 2 $ 39,646 $ 3 $ (86) $ 39,563 Corporate debt securities 2 28,759 — (117) 28,642 Commercial paper 2 4,945 — — 4,945 Total debt securities $ 73,350 $ 3 $ (203) $ 73,150 Classified as: Cash equivalents 1 & 2 $ 15,514 Short-term debt securities 2 73,150 $ 88,664 |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Balance Sheet Related Disclosures [Abstract] | |
Schedule of Inventory | Inventories consist of the following (in thousands): June 30, December 31, Raw materials $ 279 $ 1,703 Work-in-progress 628 884 Finished goods 191 266 Total inventories $ 1,098 $ 2,853 |
Schedule of Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets consist of the following (in thousands): June 30, December 31, Prepaid contract manufacturing costs $ 1,572 $ 3,542 Short term deposits 4,732 4,542 Prepaid research costs 3,355 2,822 Prepaid insurance 926 586 Prepaid marketing 343 753 Other 1,134 1,740 Total prepaid expenses and other current assets $ 12,062 $ 13,985 |
Schedule of Components of Accrued Liabilities | Accrued liabilities consist of the following (in thousands): June 30, December 31, Compensation and related benefits $ 3,925 $ 6,167 Contract research costs 1,559 4,188 Contract manufacturing costs 2,016 2,101 Product revenue reserves 1,831 1,373 Data hosting services 1,089 10 Legal fees 702 562 Other 324 1,254 Total accrued liabilities $ 11,446 $ 15,655 |
Debt (Tables)
Debt (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Debt Disclosure [Abstract] | |
Schedule of Long-Term Debt and Unamortized Discount Balances | Debt and unamortized discount balances are as follows (in thousands): June 30, December 31, Face value of debt $ 40,985 $ 40,531 Exit fee 2,600 2,600 Unamortized debt discount associated with exit fee, debt issuance costs and loan origination fees (3,236) (3,506) Total debt, net $ 40,349 $ 39,625 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Stock Option Activity | The following table summarizes stock option activity under the Company’s stock-based compensation plans during the six months ended June 30, 2023 (in thousands, except option and share data): Number of Weighted- Weighted- Aggregate Outstanding as of December 31, 2022 6,143,183 $ 9.00 6.00 $ — Granted 2,461,278 $ 1.44 Forfeited (1,267,693) $ 5.34 Outstanding as of June 30, 2023 7,336,768 $ 7.26 5.16 $ — Vested and exercisable as of June 30, 2023 4,606,523 $ 9.41 3.47 $ — |
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 June 30, Six Months Ended June 30, 2023 2022 2023 2022 Expected term (in years) 6.02 6.08 5.15-6.08 5.27-6.08 Volatility 91.26%-92.98% 70.15%-71.20% 90.21%-93.48% 68.71%-71.20% Risk free interest rate 3.50%-4.05% 2.84%-3.03% 3.50%-4.22% 1.76%-3.03% 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 six months ended June 30, 2023: Shares Weighted- Unvested shares as of December 31, 2022 641,407 $ 7.08 Granted 54,167 $ 2.26 Vested (192,147) $ 5.12 Forfeited (202,019) $ 7.23 Unvested shares as of June 30, 2023 301,408 $ 7.36 |
Summary of Non-cash Stock Based Compensation Expense | Total stock-based compensation expense recognized was as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2023 2022 2023 2022 Research and development $ 517 $ 820 $ 1,351 $ 1,445 Selling, general and administrative 228 1,388 1,936 2,810 Total $ 745 $ 2,208 $ 3,287 $ 4,255 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Leases [Abstract] | |
Maturity of Operating Leases Liabilities and Future Minimum Lease Payments | The maturities of the Company’s operating lease liabilities as of June 30, 2023 were as follows (in thousands): Undiscounted lease payments June 30, 2023 Remaining in 2023 $ 249 2024 84 2025 1 Total undiscounted payments 334 Less: imputed interest 12 Present value of future lease payments 322 Less: current portion of operating lease liabilities 321 Operating lease liabilities $ 1 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
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 Six Months Ended 2023 2022 2023 2022 Options to purchase common stock 7,336,768 6,892,009 7,336,768 6,892,009 Restricted and Performance stock units (unvested) 301,408 818,019 301,408 818,019 ESPP 345,352 89,662 345,352 89,662 Total 7,983,528 7,799,690 7,983,528 7,799,690 |
Description of Business - Addit
Description of Business - Additional Information (Detail) $ in Thousands | 6 Months Ended | ||
Jun. 30, 2023 USD ($) segment | Dec. 31, 2022 USD ($) | Jun. 30, 2022 USD ($) | |
Debt Instrument [Line Items] | |||
Number of operating segments | segment | 1 | ||
Cash, cash equivalents and short-term investments | $ 53,600 | ||
Cash and cash equivalents | 22,983 | $ 25,798 | |
Debt securities, available-for-sale | 30,600 | ||
Accumulated deficit | 480,672 | 437,193 | |
Face value of term loan | 40,985 | $ 40,531 | |
Secured Debt, Tranche B | Innovatus Loan | Line of Credit | |||
Debt Instrument [Line Items] | |||
Face value of term loan | $ 17,500 | $ 17,500 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Detail) - USD ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||
Jun. 30, 2021 | Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | |
Product Information [Line Items] | |||||||
Aggregated transaction gains (losses) | $ (29,000) | $ 26,000 | |||||
Foreign currency translation adjustment | 13,000 | $ (37,000) | $ 0 | (24,000) | $ 0 | ||
Accounts receivable, allowance for doubtful accounts | 0 | 0 | $ 0 | ||||
Bad debt expense | 0 | 0 | |||||
Inventory write down | 0 | 0 | 10,000 | 0 | |||
Early access program term (in years) | 1 year | ||||||
Product revenue, net | $ 4,643,000 | $ 4,091,000 | $ 8,761,000 | $ 6,764,000 | |||
Customer A | Financing Receivable | Customer Concentration Risk | |||||||
Product Information [Line Items] | |||||||
Concentration risk | 63% | 58% | |||||
Customer A | Revenue Benchmark | Customer Concentration Risk | |||||||
Product Information [Line Items] | |||||||
Concentration risk | 78% | 99% | 77% | 100% | |||
Customer A | Accounts Payable | Customer Concentration Risk | |||||||
Product Information [Line Items] | |||||||
Concentration risk | 43% | 12% | |||||
Customer B | Financing Receivable | Customer Concentration Risk | |||||||
Product Information [Line Items] | |||||||
Concentration risk | 37% | 42% | |||||
Customer B | Revenue Benchmark | Customer Concentration Risk | |||||||
Product Information [Line Items] | |||||||
Concentration risk | 22% | 23% | |||||
Customer B | Accounts Payable | Customer Concentration Risk | |||||||
Product Information [Line Items] | |||||||
Concentration risk | 12% | 11% | |||||
Customer C | Accounts Payable | Customer Concentration Risk | |||||||
Product Information [Line Items] | |||||||
Concentration risk | 11% | ||||||
Product revenue, net | |||||||
Product Information [Line Items] | |||||||
Product revenue, net | $ 4,393,000 | $ 3,341,000 | $ 8,511,000 | $ 6,014,000 | |||
Autorisation Temporaire D Utlisation Member | |||||||
Product Information [Line Items] | |||||||
Product revenue, net | $ 100,000 | $ 0 | $ 600,000 | $ 0 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended |
Jun. 30, 2023 | Jun. 30, 2023 | Dec. 31, 2022 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Financial assets | $ 50,923,000 | $ 50,923,000 | $ 88,664,000 |
Financial liabilities | 0 | 0 | 0 |
Other-than-temporary impairment losses | 0 | 0 | |
Unrealized gain (loss) | (40,000) | (40,000) | |
Unrealized loss position for more than 12 months | 0 | 0 | |
Fair Value, Inputs, Level 3 [Member] | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Financial assets | 0 | 0 | 0 |
Financial liabilities | $ 0 | 0 | 0 |
Transfers in or out of level 3 | $ 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 | Jun. 30, 2023 | Dec. 31, 2022 |
Cash Equivalents and Investment Securities [Line Items] | ||
Cash equivalents, amortized cost | $ 20,297 | $ 15,514 |
Cash equivalents, estimated fair value | 20,297 | 15,514 |
Debt securities, amortized cost | 30,666 | 73,350 |
Debt securities, unrealized gain | 0 | 3 |
Debt securities, unrealized loss | 40 | 203 |
Debt securities, estimated fair value | 30,626 | 73,150 |
Assets, fair value | 50,923 | 88,664 |
Corporate debt securities | Level 2 | ||
Cash Equivalents and Investment Securities [Line Items] | ||
Debt securities, amortized cost | 3,998 | 28,759 |
Debt securities, unrealized gain | 0 | 0 |
Debt securities, unrealized loss | 1 | 117 |
Debt securities, estimated fair value | 3,997 | 28,642 |
Commercial paper | Level 2 | ||
Cash Equivalents and Investment Securities [Line Items] | ||
Debt securities, amortized cost | 4,945 | |
Debt securities, unrealized gain | 0 | |
Debt securities, unrealized loss | 0 | |
Debt securities, estimated fair value | 4,945 | |
U.S. government bonds | Level 2 | ||
Cash Equivalents and Investment Securities [Line Items] | ||
Debt securities, amortized cost | 26,668 | 39,646 |
Debt securities, unrealized gain | 0 | 3 |
Debt securities, unrealized loss | 39 | 86 |
Debt securities, estimated fair value | 26,629 | 39,563 |
Short-term debt securities | Level 2 | ||
Cash Equivalents and Investment Securities [Line Items] | ||
Debt securities, estimated fair value | 30,626 | 73,150 |
Money market funds | Level 1 | ||
Cash Equivalents and Investment Securities [Line Items] | ||
Cash equivalents, amortized cost | 20,297 | 11,546 |
Cash equivalents, estimated fair value | 20,297 | 11,546 |
Cash equivalents | Level 1 | ||
Cash Equivalents and Investment Securities [Line Items] | ||
Cash equivalents, estimated fair value | $ 20,297 | |
Cash equivalents | Level 1 and 2 | ||
Cash Equivalents and Investment Securities [Line Items] | ||
Cash equivalents, estimated fair value | 15,514 | |
Commercial paper | Level 2 | ||
Cash Equivalents and Investment Securities [Line Items] | ||
Cash equivalents, amortized cost | 3,968 | |
Cash equivalents, estimated fair value | $ 3,968 |
Balance Sheet Components - Sche
Balance Sheet Components - Schedule of Inventory (Detail) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Balance Sheet Related Disclosures [Abstract] | ||
Raw materials | $ 279 | $ 1,703 |
Work-in-progress | 628 | 884 |
Finished goods | 191 | 266 |
Total inventories | $ 1,098 | $ 2,853 |
Balance Sheet Components - Sc_2
Balance Sheet Components - Schedule of Prepaid Expenses and Other Current Assets (Detail) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Balance Sheet Related Disclosures [Abstract] | ||
Prepaid contract manufacturing costs | $ 1,572 | $ 3,542 |
Short term deposits | 4,732 | 4,542 |
Prepaid research costs | 3,355 | 2,822 |
Prepaid insurance | 926 | 586 |
Prepaid marketing | 343 | 753 |
Other | 1,134 | 1,740 |
Total prepaid expenses and other current assets | $ 12,062 | $ 13,985 |
Balance Sheet Components - Sc_3
Balance Sheet Components - Schedule of Components of Accrued Liabilities (Detail) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Balance Sheet Related Disclosures [Abstract] | ||
Compensation and related benefits | $ 3,925 | $ 6,167 |
Contract research costs | 1,559 | 4,188 |
Contract manufacturing costs | 2,016 | 2,101 |
Product revenue reserves | 1,831 | 1,373 |
Data hosting services | 1,089 | 10 |
Legal fees | 702 | 562 |
Other | 324 | 1,254 |
Total accrued liabilities | $ 11,446 | $ 15,655 |
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 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Value of common stock issued during period | $ 20,564 | $ 45,610 | ||
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 |
Debt - Additional Information (
Debt - Additional Information (Detail) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | |||||
Jun. 01, 2022 USD ($) tranche $ / shares shares | Jun. 30, 2023 USD ($) | Jun. 30, 2022 USD ($) tranche | Mar. 31, 2022 USD ($) | Jun. 30, 2023 USD ($) | Jun. 30, 2022 USD ($) tranche | Dec. 31, 2022 USD ($) | |
Debt Instrument [Line Items] | |||||||
Face value of term loan | $ 40,985 | $ 40,985 | $ 40,531 | ||||
Interest expense | 1,343 | $ 934 | 2,628 | $ 1,820 | |||
Issuance of common stock | 20,564 | $ 45,610 | |||||
Loss on extinguishment of debt | 0 | 1,144 | |||||
Line of Credit | Secured Debt | Innovatus Stock Purchase Agreement | |||||||
Debt Instrument [Line Items] | |||||||
Issuance of common stock | $ 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 | ||||||
Number of tranches | tranche | 3 | ||||||
Debt Instrument, percent of interest due (in percent) | 0.0225 | ||||||
Interest due timeframe | 3 years | ||||||
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 | 1,100 | 1,100 | |||||
Interest expense | 1,300 | $ 2,600 | |||||
Effective interest rate | 13.60% | ||||||
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 | 40,000 | |||||
Line of Credit | Innovatus Loan | Secured Debt, Tranche B | |||||||
Debt Instrument [Line Items] | |||||||
Face value of term loan | $ 17,500 | $ 17,500 | $ 17,500 | $ 17,500 | |||
Line of Credit | Innovatus Loan | Secured Debt, Tranche B And C | |||||||
Debt Instrument [Line Items] | |||||||
Number of tranches | tranche | 2 | 2 | |||||
Face value of term loan | $ 35,000 | $ 35,000 | |||||
Line of Credit | Oxford Loan | Secured Debt | |||||||
Debt Instrument [Line Items] | |||||||
Face value of term loan | $ 33,500 | ||||||
Line of Credit | Amended Oxford Loan | Amended Tranche A | |||||||
Debt Instrument [Line Items] | |||||||
Loan agreement, aggregate borrowing capacity | 30,000 | ||||||
Accrued and unpaid interest | 200 | ||||||
Other final payments | 3,300 | ||||||
Repayments of loan agreement exit fee | $ 33,500 | ||||||
Loss on extinguishment of debt | $ 1,100 |
Debt - Schedule of Long-Term De
Debt - Schedule of Long-Term Debt and Unamortized Discount Balances (Detail) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Debt Disclosure [Abstract] | ||
Face value of debt | $ 40,985 | $ 40,531 |
Exit fee | 2,600 | 2,600 |
Unamortized debt discount associated with exit fee, debt issuance costs and loan origination fees | (3,236) | (3,506) |
Total debt, net | $ 40,349 | $ 39,625 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||
May 31, 2023 USD ($) employee | Jun. 30, 2023 USD ($) $ / shares shares | Jun. 30, 2022 USD ($) $ / shares shares | Jun. 30, 2023 USD ($) $ / shares shares | Jun. 30, 2022 USD ($) $ / shares shares | Feb. 06, 2023 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Common stock available for grant (in shares) | shares | 30,000 | 30,000 | ||||
Stock-based compensation expense | $ 745 | $ 2,208 | $ 3,287 | $ 4,255 | ||
Number of employees terminated | employee | 4 | |||||
Total unrecognized compensation expense | $ 6,100 | $ 6,100 | ||||
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) | $ / shares | $ 1.03 | $ 4.39 | $ 1.44 | $ 3.53 | ||
Restricted Stock Units (RSU) | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Common stock available for grant (in shares) | shares | 0 | 0 | 39,167 | 298,150 | ||
Weighted-average grant date fair value of employee stock award grants (in USD per share) | $ / shares | $ 2.26 | $ 5.22 | ||||
Stock-based compensation expense | $ 100 | $ 500 | $ 500 | $ 900 | ||
Total unrecognized compensation expense | $ 1,400 | $ 1,400 | ||||
Weighted-average period for recognition (in years) | 1 year 8 months 12 days | |||||
Performance Stock Units (PSU) | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Common stock available for grant (in shares) | shares | 0 | 15,000 | ||||
Weighted-average grant date fair value of employee stock award grants (in USD per share) | $ / shares | $ 6.87 | $ 2.26 | $ 6.87 | |||
Stock-based compensation expense | $ 200 | $ 100 | ||||
Vested (in shares) | shares | 0 | 0 | 0 | |||
Total unrecognized compensation expense | 1,400 | $ 1,400 | ||||
Weighted-average period for recognition (in years) | 1 year 8 months 12 days | |||||
Performance Stock Units (PSU) | Four Terminated Employees | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Stock compensation recognized (reversed) | $ (400) | |||||
Performance Stock Units (PSU) | Accelerated Vesting | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Vested (in shares) | shares | 15,000 | |||||
Unvested Stock Options, Performance-Based Restricted Stock Units, And Time-Based RSUs | Former CEO | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Stock compensation recognized (reversed) | $ 0 | $ 900 | ||||
Accelerated vesting | 0.50 | |||||
Restated 2013 Plan | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Number of shares available to be issued (in shares) | shares | 3,134,441 | 3,134,441 | ||||
Inducement Plan 2021 | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Number of shares available to be issued (in shares) | shares | 1,495,000 | 1,495,000 |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock Option Activity (Detail) - USD ($) $ / shares in Units, $ in Thousands | 6 Months Ended | 12 Months Ended |
Jun. 30, 2023 | Dec. 31, 2022 | |
Number of Options | ||
Number of options, outstanding, beginning balance (in shares) | 6,143,183 | |
Number of options, granted (in shares) | 2,461,278 | |
Number of options, forfeited (in shares) | (1,267,693) | |
Number of options, outstanding, ending balance (in shares) | 7,336,768 | 6,143,183 |
Number of options, vested and exercisable (in shares) | 4,606,523 | |
Weighted- Average Exercise Price | ||
Weighted-average exercise price, outstanding, beginning balance (in USD per share) | $ 9 | |
Weighted-average exercise price, granted (in USD per share) | 1.44 | |
Weighted-average exercise price, forfeited (in USD per share) | 5.34 | |
Weighted-average exercise price, outstanding, ending balance (in USD per share) | 7.26 | $ 9 |
Weighted-average exercise price, vested and exercisable (in USD per share) | $ 9.41 | |
Stock Options Additional Disclosures | ||
Weighted average remaining contractual life, beginning balance (in years) | 5 years 1 month 28 days | 6 years |
Aggregate intrinsic value, beginning balance | $ 0 | |
Weighted average remaining contractual life, ending balance (in years) | 5 years 1 month 28 days | 6 years |
Aggregate intrinsic value, ending balance | $ 0 | $ 0 |
Weighted average remaining contractual life, vested and exercisable (in years) | 3 years 5 months 19 days | |
Aggregate intrinsic value, vested and exercisable | $ 0 |
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 | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Expected term (in years) | 6 years 7 days | 6 years 29 days | ||
Volatility, minimum | 91.26% | 70.15% | 93.48% | 68.71% |
Volatility, maximum | 92.98% | 71.20% | 90.21% | 71.20% |
Risk free interest rate, minimum | 3.50% | 2.84% | 3.50% | 1.76% |
Risk free interest rate, maximum | 4.05% | 3.03% | 4.22% | 3.03% |
Dividend yield | 0% | 0% | 0% | 0% |
Minimum | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Expected term (in years) | 5 years 1 month 24 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 |
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) - $ / shares | 3 Months Ended | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
RSU and PSU Roll Forward Activity | |||
Stock options granted (in shares) | 30,000 | 30,000 | |
Restricted Stock Units and Performance Stock Unit | |||
RSU and PSU Roll Forward Activity | |||
Unvested shares, beginning balance (in shares) | 641,407 | ||
Stock options granted (in shares) | 54,167 | ||
Vested (in shares) | (192,147) | ||
Forfeited (in shares) | (202,019) | ||
Unvested shares, ending balance (in shares) | 301,408 | ||
Weighted-Average | |||
Weighted average grant-date fair value of options beginning balance (in USD per share) | $ 7.08 | ||
Weighted-average grant date fair value of employee stock award grants (in USD per share) | 2.26 | ||
Weighted average grant-date fair value of options vested (in USD per share) | 5.12 | ||
Weighted average grant-date fair value of options forfeited (in USD per share) | 7.23 | ||
Weighted average grant-date fair value of options ending balance (in USD per share) | $ 7.36 |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Non-cash Stock Based Compensation Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total stock-based compensation expense | $ 745 | $ 2,208 | $ 3,287 | $ 4,255 |
Research and development | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total stock-based compensation expense | 517 | 820 | 1,351 | 1,445 |
Selling, general and administrative | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total stock-based compensation expense | $ 228 | $ 1,388 | $ 1,936 | $ 2,810 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Income Tax Disclosure [Abstract] | ||||
Provision for income taxes | $ 2,000 | $ 17,000 | $ 4,000 | $ 26,000 |
Effective tax rate | (0.01%) | (0.06%) |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) $ in Thousands | 3 Months Ended | 6 Months Ended | |||||||
Jun. 30, 2023 USD ($) | Jun. 30, 2022 USD ($) | Jun. 30, 2023 USD ($) | Jun. 30, 2022 USD ($) | Feb. 28, 2023 | Dec. 31, 2022 | Nov. 15, 2022 claim | Nov. 08, 2022 executive | Oct. 31, 2017 USD ($) ft² | |
Other Commitments [Line Items] | |||||||||
Rent expense recognized for company's operating leases | $ 100 | $ 100 | $ 300 | $ 300 | |||||
Variable lease payments for operating leases | $ 23 | $ 23 | 38 | 46 | |||||
Operating cash outflows for operating lease liabilities | $ 300 | $ 300 | |||||||
Weighted-average remaining lease term (in years) | 8 months 12 days | 8 months 12 days | 1 year 2 months 12 days | ||||||
Weighted-average discount rate (in percent) | 12.82% | 12.82% | 12.82% | ||||||
Number of former executives | executive | 2 | ||||||||
Number of claims | claim | 2 | ||||||||
Palo Alto, California | |||||||||
Other Commitments [Line Items] | |||||||||
Total leased space | ft² | 8,029 | ||||||||
Lease renewal term | 1 year | 3 years | |||||||
Renewal extension term | 1 year | ||||||||
Security deposit | $ 300 |
Commitments and Contingencies_2
Commitments and Contingencies - Maturity of Operating Leases Liabilities and Future Minimum Lease Payments (Detail) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Leases [Abstract] | ||
Remaining in 2023 | $ 249 | |
2024 | 84 | |
2025 | 1 | |
Total undiscounted payments | 334 | |
Less: imputed interest | 12 | |
Present value of future lease payments | 322 | |
Less: current portion of operating lease liabilities | 321 | $ 491 |
Operating lease liabilities | $ 1 | $ 83 |
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 | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Anti-dilutive securities | 7,983,528 | 7,799,690 | 7,983,528 | 7,799,690 |
Options to purchase common stock | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Anti-dilutive securities | 7,336,768 | 6,892,009 | 7,336,768 | 6,892,009 |
Restricted and Performance stock units (unvested) | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Anti-dilutive securities | 301,408 | 818,019 | 301,408 | 818,019 |
ESPP | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Anti-dilutive securities | 345,352 | 89,662 | 345,352 | 89,662 |