Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2023 | Feb. 28, 2024 | Jun. 30, 2023 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2023 | ||
Document Fiscal Year Focus | 2023 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | HRTX | ||
Entity Registrant Name | HERON THERAPEUTICS, INC. /DE/ | ||
Entity Central Index Key | 0000818033 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Accelerated Filer | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Common Stock, Shares Outstanding | 150,328,585 | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | true | ||
Document Financial Statement Error Correction [Flag] | false | ||
Entity Shell Company | false | ||
Entity File Number | 001-33221 | ||
Entity Tax Identification Number | 94-2875566 | ||
Entity Address, Address Line One | 4242 CAMPUS POINT COURT | ||
Entity Address, Address Line Two | SUITE 200 | ||
Entity Address, City or Town | SAN DIEGO | ||
Entity Address, State or Province | CA | ||
Entity Address, Postal Zip Code | 92121 | ||
City Area Code | 858 | ||
Local Phone Number | 251-4400 | ||
Entity Interactive Data Current | Yes | ||
Entity Incorporation, State or Country Code | DE | ||
Document Annual Report | true | ||
Entity Public Float | $ 119.5 | ||
Document Transition Report | false | ||
Title of 12(b) Security | Common Stock, par value $0.01 per share | ||
Security Exchange Name | NASDAQ | ||
Auditor Name | WithumSmith+Brown, PC | ||
Auditor Location | San Francisco, California | ||
Auditor Firm ID | 100 | ||
Documents Incorporated by Reference | Portions of the registrant’s Definitive Proxy Statement related to its 2024 Annual Meeting of Stockholders to be held on or about June 13, 2024 are incorporated by reference into Part III of this Annual Report on Form 10-K. Such Definitive Proxy Statement will be filed with the U.S. Securities and Exchange Commission within 120 days after the end of the fiscal year to which this report relates. Except as expressly incorporated by reference, the registrant’s Definitive Proxy Statement shall not be deemed to be part of this report. |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 28,677 | $ 15,364 |
Short-term investments | 51,732 | 69,488 |
Accounts receivable, net | 60,137 | 52,049 |
Inventory | 42,110 | 54,573 |
Prepaid expenses and other current assets | 6,118 | 13,961 |
Total current assets | 188,774 | 205,435 |
Property and equipment, net | 20,166 | 22,160 |
Right-of-use lease assets | 5,438 | 7,645 |
Other assets | 8,128 | 15,711 |
Total assets | 222,506 | 250,951 |
Current liabilities: | ||
Accounts payable | 3,240 | 3,225 |
Accrued clinical and manufacturing liabilities | 22,291 | 24,468 |
Accrued payroll and employee liabilities | 9,224 | 13,416 |
Other accrued liabilities | 41,855 | 38,552 |
Current lease liabilities | 3,075 | 2,694 |
Total current liabilities | 79,685 | 82,355 |
Non-current lease liabilities | 2,800 | 5,499 |
Non-current notes payable, net | 24,263 | |
Non-current convertible notes payable, net | 149,490 | 149,284 |
Other non-current liabilities | 241 | 241 |
Total liabilities | 256,479 | 237,379 |
Commitments and contingencies (see Note 6) | ||
Stockholders’ equity: | ||
Preferred stock, $0.01 par value: 2,500,000 shares authorized; no shares issued or outstanding at December 31, 2023 and 2022 | ||
Common stock, $0.01 par value: 225,000,000 shares authorized; 150,285,044 shares issued and outstanding at December 31, 2023 and 119,154,538 shares issued and outstanding at December 31, 2022 | 1,503 | 1,191 |
Additional paid-in capital | 1,870,525 | 1,807,855 |
Accumulated other comprehensive income (loss) | 13 | (19) |
Accumulated deficit | (1,906,014) | (1,795,455) |
Total stockholders' (deficit) equity | (33,973) | 13,572 |
Total liabilities and stockholders’ equity | $ 222,506 | $ 250,951 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized (in shares) | 2,500,000 | 2,500,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized (in shares) | 225,000,000 | 225,000,000 |
Common stock, shares issued (in shares) | 150,285,044 | 119,154,538 |
Common stock, shares outstanding (in shares) | 150,285,044 | 119,154,538 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Revenues: | ||
Net product sales | $ 127,044 | $ 107,672 |
Cost of product sales | 65,105 | 54,874 |
Gross profit | 61,939 | 52,798 |
Operating expenses: | ||
Research and development | 55,897 | 107,506 |
General and administrative | 49,014 | 37,437 |
Sales and marketing | 67,643 | 82,513 |
Total operating expenses | 172,554 | 227,456 |
Loss from operations | (110,615) | (174,658) |
Other income (expense), net: | ||
Interest income | 3,364 | 1,638 |
Interest expense | (3,868) | (2,474) |
Other income (expense) | 560 | (6,530) |
Total other income (expense), net | 56 | (7,366) |
Net loss | (110,559) | (182,024) |
Other comprehensive income (loss): | ||
Unrealized gains (losses) on short-term investments | 32 | (13) |
Comprehensive loss | $ (110,527) | $ (182,037) |
Basic net loss per share | $ (0.8) | $ (1.67) |
Shares used in computing basic net loss per share | 138,135 | 108,876 |
Diluted net loss per share | $ (0.8) | $ (1.67) |
Shares used in computing diluted net loss per share | 138,135 | 108,876 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' (Deficit) Equity - USD ($) shares in Thousands, $ in Thousands | Total | Private Placement | Common Stock | Common Stock Private Placement | Additional Paid-In Capital | Additional Paid-In Capital Private Placement | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit |
Balance at Dec. 31, 2021 | $ 77,570 | $ 1,020 | $ 1,689,987 | $ (6) | $ (1,613,431) | |||
Balance (in shares) at Dec. 31, 2021 | 102,005 | |||||||
Issuance of common stock under Employee Stock Purchase Plan | 1,444 | $ 4 | 1,440 | |||||
Issuance of common stock under Employee Stock Purchase Plan (in shares) | 407 | |||||||
Issuance of common stock under equity incentive plan | (1,530) | $ 6 | (1,536) | |||||
Issuance of common stock under equity incentive plan (in shares) | 614 | |||||||
Issuance of common stock in a private placement | $ 75,145 | $ 161 | $ 74,984 | |||||
Issuance of common stock in a private placement (in shares) | 16,129 | |||||||
Stock-based compensation expense | 42,980 | 42,980 | ||||||
Net loss | (182,024) | (182,024) | ||||||
Net unrealized gain (loss) on short-term investments | (13) | (13) | ||||||
Comprehensive loss | (182,037) | |||||||
Balance at Dec. 31, 2022 | 13,572 | $ 1,191 | 1,807,855 | (19) | (1,795,455) | |||
Balance (in shares) at Dec. 31, 2022 | 119,155 | |||||||
Issuance of common stock under Employee Stock Purchase Plan | 904 | $ 7 | 897 | |||||
Issuance of common stock under Employee Stock Purchase Plan (in shares) | 717 | |||||||
Issuance of common stock under equity incentive plan | (903) | $ 11 | (914) | |||||
Issuance of common stock under equity incentive plan (in shares) | 1,130 | |||||||
Issuance of common stock in a private placement | $ 29,755 | $ 208 | $ 29,547 | |||||
Issuance of common stock in a private placement (in shares) | 20,735 | |||||||
Issuance of common stock on exercise of pre-funded warrants | 1 | $ 86 | (85) | |||||
Issuance of common stock on exercise of pre-funded warrants (in shares) | 8,548 | |||||||
Issuance of warrants in debt financing | 371 | 371 | ||||||
Stock-based compensation expense | 32,854 | 32,854 | ||||||
Net loss | (110,559) | (110,559) | ||||||
Net unrealized gain (loss) on short-term investments | 32 | 32 | ||||||
Comprehensive loss | (110,527) | |||||||
Balance at Dec. 31, 2023 | $ (33,973) | $ 1,503 | $ 1,870,525 | $ 13 | $ (1,906,014) | |||
Balance (in shares) at Dec. 31, 2023 | 150,285 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Operating activities: | ||
Net loss | $ (110,559) | $ (182,024) |
Adjustments to reconcile net loss to net cash used for operating activities: | ||
Stock-based compensation expense | 32,854 | 42,980 |
Depreciation and amortization | 2,899 | 2,889 |
Amortization of debt discount | 133 | |
Amortization of debt issuance costs | 206 | 202 |
Accretion of discount on short-term investments | (1,739) | (736) |
Impairment of property and equipment | 617 | 209 |
Loss on disposal of property and equipment | 10 | 74 |
Change in operating assets and liabilities: | ||
Accounts receivable | (8,088) | (16,550) |
Inventory | 12,463 | (6,191) |
Prepaid expenses and other assets | 15,426 | 1,010 |
Accounts payable | 15 | (578) |
Accrued clinical and manufacturing liabilities | (2,177) | 752 |
Accrued payroll and employee liabilities | (4,192) | (1,847) |
Other accrued liabilities | 3,343 | 12,898 |
Net cash used in operating activities | (58,789) | (146,912) |
Investing activities: | ||
Purchases of short-term investments | (87,658) | (145,683) |
Maturities and sales of short-term investments | 107,185 | 143,957 |
Purchases of property and equipment | (1,545) | (1,825) |
Proceeds from the sale of property and equipment | 13 | 227 |
Net cash provided by (used in) investing activities | 17,995 | (3,324) |
Financing activities: | ||
Net proceeds from sale of common stock | 29,755 | 75,145 |
Net proceeds from notes financing | 24,350 | |
Proceeds from purchases under the Employee Stock Purchase Plan | 904 | 1,444 |
Payments for stock issued under the equity incentive plan | (903) | (1,530) |
Proceeds from warrant exercises | 1 | |
Net cash provided by financing activities | 54,107 | 75,059 |
Net increase (decrease) in cash and cash equivalents | 13,313 | (75,177) |
Cash and cash equivalents at beginning of year | 15,364 | 90,541 |
Cash and cash equivalents at end of year | 28,677 | 15,364 |
Supplemental disclosure of cash flow information: | ||
Interest paid | $ 3,059 | $ 2,250 |
Organization and Business
Organization and Business | 12 Months Ended |
Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Business | 1. Organization and Business We are a commercial-stage biotechnology company focused on improving the lives of patients by developing and commercializing therapeutic innovations that improve medical care. Our advanced science, patented technologies, and innovative approach to drug discovery and development have allowed us to create and commercialize a portfolio of products that aim to advance the standard of care for acute care and oncology patients. ZYNRELEF ® (bupivacaine and meloxicam) extended-release solution (“ZYNRELEF”) is approved in the United States (“U.S.”) for the management of postoperative pain. APONVIE ® (aprepitant) injectable emulsion (“APONVIE”) is approved in the U.S. for the prevention of postoperative nausea and vomiting. CINVANTI ® (aprepitant) injectable emulsion (“CINVANTI”) and SUSTOL ® (granisetron) extended-release injection (“SUSTOL”) are both approved in the U.S. for the prevention of chemotherapy-induced nausea and vomiting. As of December 31, 2023, we had cash, cash equivalents, and short-term investments of $ 80.4 million. Based on our current operating plan and projections, management believes that the Company's cash, cash equivalents and short-term investments will be sufficient to meet the Company's anticipated cash requirements for a period of at least one year from the date this Annual Report on Form 10-K is filed with the U.S. Securities and Exchange Commission (“SEC”). |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Principles of Consolidation The accompanying consolidated financial statements include the accounts of Heron Therapeutics, Inc. and its wholly-owned subsidiary, Heron Therapeutics B.V., which was organized in the Netherlands in March 2015. Heron Therapeutics B.V. has no operations and no material assets or liabilities, and there have been no significant transactions related to Heron Therapeutics B.V. since its inception. Use of Estimates The preparation of financial statements in conformity with generally accepted accounting principles in the U.S. (“GAAP”) requires management to make estimates and assumptions that affect the amounts reported in the financial statements and disclosures made in the accompanying notes to the financial statements. Our significant accounting policies that involve significant judgment and estimates include revenue recognition, investments, inventory and the related reserves, accrued clinical and manufacturing liabilities, income taxes and stock-based compensation. Actual results could differ materially from those estimates. Cash, Cash Equivalents and Short-term Investments Cash and cash equivalents consist of cash and highly liquid investments with contractual maturities of three months or less from the original purchase date. Short-term investments consist of securities with contractual maturities of greater than three months from the original purchase date. Securities with contractual maturities greater than one year are classified as short-term investments on the consolidated balance sheets, as we have the ability, if necessary, to liquidate these securities to meet our liquidity needs in the next 12 months. We have classified our short-term investments as available-for-sale securities in the accompanying consolidated financial statements. Available-for-sale securities are stated at fair market value, with net changes in unrealized gains and losses reported in other comprehensive loss and realized gains and losses included in other income (expense), net. The cost of securities sold is based on the specific identification method. Interest and dividends on securities classified as available-for-sale are included in interest income within other income (expense), net. Our bank and investment accounts have been placed under a control agreement in accordance with our working capital line of credit (see Note 8). Fair Value of Financial Instruments A company may elect to use fair value to measure accounts receivable, available-for-sale securities, accounts payable, guarantees and issued debt, among others. If the use of fair value is elected, any upfront costs and fees related to the item such as debt issuance costs must be recognized in earnings and cannot be deferred. The fair value election is irrevocable and generally made on an instrument-by-instrument basis, even if a company has similar instruments that it elects not to measure based on fair value. Unrealized gains and losses on existing items for which fair value has been elected are reported as a cumulative adjustment to beginning retained earnings and any changes in fair value are recognized in earnings. We have elected to not apply the fair value option to our financial assets and liabilities. Financial instruments, including cash and cash equivalents, receivables, inventory, prepaid expenses, other current assets, accounts payable and accrued expenses, are carried at cost, which is considered to be representative of their respective fair values because of the short-term maturity of these instruments. Short-term available-for-sale investments are carried at fair value. Our convertible notes and non-current notes payable outstanding at December 31, 2023 and 2022 do not have a readily available ascertainable market value, however, their carrying value, which is measured at carrying value less unamortized debt issuance costs or debt discounts, is considered to approximate their fair value. Concentration of Credit Risk Cash, cash equivalents and short-term investments are financial instruments that potentially subject us to concentrations of credit risk. We deposit our cash in financial institutions. At times, such deposits may be in excess of insured limits. We have not experienced any losses in such accounts and believe we are not exposed to significant risk on our cash, cash equivalents and short-term investments. Any loss incurred or a lack of access to such funds could have a significant adverse impact on our financial condition, results of operations, and cash flows. We may also invest our excess cash in money market funds, U.S. government and agencies, corporate debt securities and commercial paper. We have established guidelines relative to our diversification of our cash investments and their maturities in an effort to maintain safety and liquidity. These guidelines are periodically reviewed and modified to take advantage of trends in yields and interest rates. ZYNRELEF, APONVIE, CINVANTI and SUSTOL (collectively, our “Products”) are distributed in the U.S. through a limited number of specialty distributors and full line wholesalers (collectively, “Customers”) that resell to healthcare providers and hospitals, the end users of our Products. The following includes the percentage of net product sales and accounts receivable balances for our three major Customers, each of which comprised 10% or more of our net product sales: Net Product Accounts Year Ended As of Customer A 43.3 % 42.1 % Customer B 36.8 % 36.1 % Customer C 19.0 % 21.5 % Total 99.1 % 99.7 % Accounts Receivable, Net Accounts receivable are recorded at the invoice amount, net of an allowance for credit losses. The allowance for credit losses reflects accounts receivable balances that are believed to be uncollectible. In estimating the allowance for credit losses, we consider: (1) our historical experience with collections and write-offs; (2) the credit quality of our Customers and any recent or anticipated changes thereto; (3) the outstanding balances and past due amounts from our Customers; and (4) reasonable and supportable forecast of economic conditions expected to exist throughout the contractual term of the receivable. As of December 31, 2023 and 2022, we determined that an allowance for credit losses was not required. For the years ended December 31, 2023 and 2022, we did not have any material write-offs of accounts receivable balances. Inventory Inventory is stated at the lower of cost or estimated net realizable value on a first-in, first-out, or FIFO, basis. We periodically analyze our inventory levels and write down inventory that has become obsolete, inventory that has a cost basis in excess of its estimated realizable value and inventory quantities that are in excess of expected sales requirements as cost of product sales. The determination of whether inventory costs will be realizable requires estimates by management. If actual market conditions are less favorable than projected by management, additional write-downs of inventory may be required, which would be recorded as cost of product sales. Property and Equipment Property and equipment is stated at cost less accumulated depreciation and amortization. Depreciation is calculated on a straight-line basis over the estimated useful lives of the assets (generally 5 years ). Leasehold improvements are stated at cost and amortized on a straight-line basis over the shorter of the estimated useful life of the asset or the lease term. Impairment of Long-Lived Assets If indicators of impairment exist, we assess the recoverability of the affected long-lived assets by determining whether the carrying value of such assets can be recovered through undiscounted future operating cash flows. If impairment is indicated, we measure the amount of such impairment by comparing the carrying value of the asset to the fair value of the asset and record the impairment as a reduction in the carrying value of the related asset with a corresponding charge to operating expenses. Estimating the undiscounted future operating cash flows associated with long-lived assets requires judgment and assumptions that could differ materially from actual results. Leases We determine if an arrangement is a lease or contains lease components at inception. Operating leases with an initial term greater than 12 months are recorded as lease liabilities with corresponding right-of-use (“ROU”) lease assets on the consolidated balance sheets. ROU lease assets represent our right to use the underlying assets over the lease term, and lease liabilities represent the present value of our obligation to make lease payments arising from the lease. Lease liabilities are recognized at the lease commencement based on the present value of lease payments over the lease term. As most of our leases do not provide an implicit rate, we use our incremental borrowing rate based on the information available at the commencement date in determining the present value of lease payments. We use the implicit rate when readily determinable. The ROU lease assets equal the lease liabilities, less unamortized lease incentives, unamortized initial direct costs and the cumulative difference between rent expense and amounts paid under the lease. The lease term includes any option to extend or terminate the lease when it is reasonably certain that we will exercise that option. Lease expense is recognized on a straight-line basis over the lease term. We have elected the practical expedient to not separate lease and non-lease components. Revenue Recognition Revenue is recognized in accordance with the Financial Accounting Standards Board (the “FASB”) Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers (“Topic 606”). Topic 606 is based on the principle that revenue should be recognized to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. Product Sales Our Products are distributed in the U.S. through a limited number of Customers that resell to healthcare providers and hospitals, the end users of our Products. Revenue is recognized in an amount that reflects the consideration we expect to receive in exchange for our Products. To determine revenue recognition for contracts with customers within the scope of Topic 606, we perform the following 5 steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations of the contract(s); (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract(s); and (v) recognize revenue when (or as) we satisfy the performance obligations. We recognize revenue from product sales when there is a transfer of control of the product to our Customers. We typically determine transfer of control based on when the product is delivered, and title passes to our Customers. Product Sales Allowances We recognize product sales allowances as a reduction of product sales in the same period the related revenue is recognized. Product sales allowances are based on amounts owed or to be claimed on the related sales. Such variable consideration includes estimates that take into consideration the terms of our agreements with Customers, historical product returns, rebates or discounts taken, the shelf life of the product and specific known market events, such as competitive pricing and new product introductions. If actual future results vary from our estimates, we may need to adjust these estimates, which could have an effect on product sales and earnings in the period of adjustment. Our product sales allowances include: • Product Returns—We allow our Customers to return product for credit beginning three months prior to the product expiration date and up to 12 months after the product expiration date. As such, there may be a significant period of time between the time the product is shipped and the time the credit is issued on returned product. • Distributor Fees—We pay distribution service fees to our Customers based on a contractually fixed percentage of the wholesale acquisition cost and fees for data. These fees are paid no later than two months after the quarter in which product was shipped. • Group Purchasing Organization (“GPO”) Discounts and Rebates—We offer cash discounts to GPO members. These discounts are taken when the GPO members purchase product from our Customers, who then charge back to us the discount amount. Additionally, we offer volume and contract-tier rebates to GPO members. Rebates are based on actual purchase levels during the quarterly rebate purchase period. • GPO Administrative Fees—We pay administrative fees to GPOs for services and access to data. These fees are based on contracted terms and are paid after the quarter in which the product was purchased by the GPOs’ members. • Medicaid Rebates—We participate in Medicaid rebate programs, which provide assistance to certain low-income patients based on each individual state’s guidelines regarding eligibility and services. Under the Medicaid rebate programs, we pay a rebate to each participating state, generally within six months after the quarter in which the product was sold. • Prompt Pay Discounts—We may provide discounts on product sales to our Customers for prompt payment based on contractual terms. We believe our estimated allowance for product returns and GPO discounts requires a high degree of judgment and is subject to change based on our experience and certain quantitative and qualitative factors. We believe our estimated allowances for distributor fees, GPO rebates and administrative fees, Medicaid rebates and prompt pay discounts do not require a high degree of judgment because the amounts are settled within a relatively short period of time. Our product sales allowances and related accruals are evaluated each reporting period and adjusted when trends or significant events indicate that a change in estimate is appropriate. Changes in product sales allowance estimates could materially affect our results of operations and financial position. Accrued Clinical Liabilities We accrue clinical costs based on work performed, which relies on estimates of the progress of the trials and the related expenses incurred. Clinical trial related contracts vary significantly in duration, and may be for a fixed amount, based on the achievement of certain contingent events or deliverables, a variable amount based on actual costs incurred, capped at a certain limit or contain a combination of these elements. Revisions are recorded to research and development expense in the period in which the facts that give rise to the revision become known. Historically, revisions have not resulted in material changes to research and development expense; however, a modification in the protocol of a clinical trial or cancellation of a clinical trial could result in a material charge to our results of operations. Research and Development Expense All costs of research and development are expensed in the period incurred. Research and development expense primarily consists of personnel and related costs, stock-based compensation expense, fees paid to outside service providers and consultants, facilities costs and materials used in clinical and preclinical trials and research and development. Patent Costs We incur outside legal fees in connection with filing and maintaining our various patent applications. All patent costs are expensed as incurred and are included in general and administrative expense in the consolidated statements of operations and comprehensive loss. Stock-Based Compensation Expense We estimate the fair value of each option grant using the Black-Scholes option pricing model and for market-based stock option grants using the Monte Carlo simulation model. This fair value is then amortized using the straight-line single-option method of attributing the value of stock-based compensation to expense over the requisite service periods of the awards. Forfeitures are accounted for, as incurred, as a reversal of stock-based compensation expense related to awards that will not vest. The Black-Scholes option pricing model and the Monte Carlo simulation model both require inputs of complex and subjective assumptions, including each option’s expected life and price volatility of the underlying stock. Warrants We have issued warrants to purchase shares of our common stock in conjunction with certain equity and debt financings or in exchange for services. The terms of the warrants were evaluated to determine the appropriate classification as equity or a liability. Income Taxes We recognize the impact of a tax position in our consolidated financial statements if the position is more likely than not to be sustained on examination and on the technical merits of the position. The total amount of unrecognized tax benefits, if recognized, would affect other tax accounts, primarily deferred taxes in future periods, and would not affect our effective tax rate, since we maintain a full valuation allowance against our deferred tax assets (see Note 12). We recognize interest and penalties related to income tax matters in income tax expense. Comprehensive Loss Comprehensive loss is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources. Net changes in unrealized gains and losses on available-for-sale securities are included in other comprehensive income (loss) and represent the difference between our net loss and comprehensive loss for both periods presented. Net Loss per Share Basic net loss per share is calculated by dividing the net loss by the weighted-average number of common shares outstanding for the period, including pre-funded warrants to purchase shares of common stock. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of common shares and common stock equivalents outstanding for the period determined using the treasury stock method. For purposes of this calculation, stock options, restricted stock units, warrants and shares of common stock underlying convertible notes are considered to be common stock equivalents and are included in the calculation of diluted net loss per share only when their effect is dilutive. Because we have incurred a net loss for both periods presented in the consolidated statements of operations and comprehensive loss, the following common stock equivalents were not included in the computation of net loss per share because their effect would be anti-dilutive (in thousands): December 31, 2023 2022 Stock options outstanding 24,575 20,749 Restricted stock units outstanding 1,405 3,167 Warrants outstanding 298 8,548 Shares of common stock underlying convertible notes outstanding 9,819 9,819 Segment Reporting Management has determined that we operate in one business segment which is the development and commercialization of therapeutic innovations. All revenues for the years ended December 31, 2023 and 2022 were generated from customers in the U.S. Recent Accounting Pronouncements Not Yet Adopted In December 2023, FASB issued Accounting Standards Update No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”), to enhance income tax reporting disclosures and require disclosure of specific categories in the tabular rate reconciliation. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024, on a prospective basis. Early adoption and retrospective application are permitted. We are currently evaluating the impact on our disclosures. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 3. Fair Value Measurements Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The FASB ASC Topic 820, Fair Value Measurements & Disclosures , establishes a fair value hierarchy which prioritizes the inputs used in measuring fair value as follows: • Level 1—Observable inputs such as quoted prices in active markets for identical assets or liabilities. • Level 2—Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. • Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. We measure cash, cash equivalents and short-term investments at fair value on a recurring basis. The fair values of such assets were as follows (in thousands): Fair Value Measurements at Reporting Date Using Balance at Quoted Significant Significant Cash and money market funds $ 23,441 $ 23,441 $ — $ — U.S. treasury bills and government agency obligations 31,636 31,636 — — U.S. corporate debt securities 16,889 — 16,889 — Foreign corporate debt securities 5,460 — 5,460 — U.S. commercial paper 1,990 — 1,990 — Foreign commercial paper 993 — 993 — Total $ 80,409 $ 55,077 $ 25,332 $ — Fair Value Measurements at Reporting Date Using Balance at Quoted Significant Significant Cash and money market funds $ 13,867 $ 13,867 $ — $ — U.S. treasury bills and agency obligations 35,715 35,715 — — U.S. corporate debt securities 1,497 — 1,497 — U.S. commercial paper 5,481 — 5,481 — Foreign commercial paper 28,292 — 28,292 — Total $ 84,852 $ 49,582 $ 35,270 $ — We have no t transferred any investment securities between the three levels of the fair value hierarchy. As of December 31, 2023, cash equivalents included $ 5.3 million of available-for-sale securities with contractual maturities of three months or less and short-term investments included $ 51.7 million of available-for-sale securities with contractual maturities of three months to one year. As of December 31, 2022, cash equivalents included $ 1.5 million of available-for-sale securities with contractual maturities of three months or less and short-term investments included $ 69.5 million of available-for-sale securities with contractual maturities of three months to one year. The money market funds as of December 31, 2023 and 2022 are included in cash and cash equivalents on the consolidated balance sheets. |
Balance Sheet Details
Balance Sheet Details | 12 Months Ended |
Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Balance Sheet Details | 4. Balance Sheet Details Short-Term Investments The following is a summary of our short-term investments (in thousands): December 31, 2023 Amortized Gross Gross Estimated U.S. treasury bills and government agency obligations $ 31,625 $ 11 $ — $ 31,636 U.S. corporate debt securities 11,652 1 — 11,653 Foreign corporate debt securities 5,459 1 — 5,460 U.S. commercial paper 1,991 — ( 1 ) 1,990 Foreign commercial paper 993 — — 993 Total $ 51,720 $ 13 $ ( 1 ) $ 51,732 December 31, 2022 Amortized Gross Gross Estimated U.S. treasury bills and agency obligations $ 35,734 $ — $ ( 19 ) $ 35,715 U.S. commercial paper 5,481 — — 5,481 Foreign commercial paper 28,292 — — 28,292 Total $ 69,507 $ — $ ( 19 ) $ 69,488 The amortized cost of debt securities is adjusted for amortization of premiums and accretion of discounts to maturity. We regularly monitor and evaluate the realizable value of our marketable securities. We did no t recognize any impairment losses for the years ended December 31, 2023 and 2022. Unrealized gains and losses associated with our investments are reported in accumulated other comprehensive income (loss). For the year ended December 31, 2023, we recorded $ 32,000 in net unrealized gains associated with our short-term investments. For the year ended December 31, 2022, we recorded $ 13,000 in net unrealized losses associated with our short-term investments. Realized gains and losses associated with our investments, if any, are reported in the statements of operations and comprehensive loss. We recognized $ 1,000 in realized losses during the year ended December 31, 2023. We did no t recognize any realized gains or losses during the year ended December 31, 2022. Inventory Inventory consists of the following (in thousands): December 31, 2023 2022 Raw materials $ 17,643 $ 15,137 Work in process 14,550 20,723 Finished goods 9,917 18,713 Total inventory $ 42,110 $ 54,573 As of December 31, 2023, total inventory included $ 11.2 million related to ZYNRELEF, $ 26.4 million related to CINVANTI, $ 4.1 million related to SUSTOL and $ 0.4 million related to APONVIE. As of December 31, 2022, total inventory included $ 30.9 million related to ZYNRELEF, $ 19.9 million related to CINVANTI, $ 2.6 million related to SUSTOL and $ 1.2 million related to APONVIE. Cost of product sales for the years ended December 31, 2023 and 2022 included charges of $ 20.3 million and $ 8.9 million, respectively, resulting primarily from the write-off of ZYNRELEF inventory. Prepaid Expenses and Other Assets Prepaid expenses and other assets consist of the following (in thousands): December 31, 2023 2022 Prepaid expenses $ 11,731 $ 21,120 Prepaid insurance 1,910 1,947 Interest receivables 310 154 Deposits 274 254 Other receivables 21 6,197 Total prepaid expenses and other assets $ 14,246 $ 29,672 Property and Equipment Property and equipment, net consists of the following (in thousands): December 31, 2023 2022 Scientific equipment $ 34,027 $ 33,318 Leasehold improvements 647 647 Computer equipment and software 1,506 1,506 Furniture, fixtures and office equipment 1,014 982 Property and equipment, gross 37,194 36,453 Less: accumulated depreciation and amortization ( 17,028 ) ( 14,293 ) Property and equipment, net $ 20,166 $ 22,160 Depreciation and amortization expense for the years ended December 31, 2023 and 2022 was $ 2.9 million for both periods. As of December 31, 2023 and 2022, $ 6.3 million and $ 5.4 million of property and equipment, respectively, was in process and not depreciated during the respective years. Accrued Payroll and Employee Liabilities and Other Accrued Liabilities Accrued payroll and employee liabilities consist of the following (in thousands): December 31, 2023 2022 Accrued employee salaries and benefits $ 1,371 $ 2,134 Accrued bonuses 5,499 7,783 Accrued vacation 2,354 3,499 Total accrued payroll and employee liabilities $ 9,224 $ 13,416 Other accrued liabilities consist of the following (in thousands): December 31, 2023 2022 Accrued product sales allowances $ 36,529 $ 33,317 Accrued consulting and professional fees 3,940 4,236 Accrued accounts payable 559 363 Accrued interest 412 94 Other accrued liabilities 415 542 Total other accrued liabilities $ 41,855 $ 38,552 |
Revenue Recognition
Revenue Recognition | 12 Months Ended |
Dec. 31, 2023 | |
Revenue from Contract with Customer [Abstract] | |
Revenue Recognition | 5. Revenue Recognition The following provides disaggregated net product sales (in thousands): For the Years Ended December 31, 2023 2022 CINVANTI net product sales $ 94,869 $ 87,245 SUSTOL net product sales 13,057 10,231 ZYNRELEF net product sales 17,727 10,196 APONVIE net product sales 1,391 — Total net product sales $ 127,044 $ 107,672 The following provides a summary of activity with respect to our product returns, distributor fees and discounts, rebates, administrative and other fees, which are included in other accrued liabilities on the consolidated balance sheets (in thousands): Discounts, Rebates, Product Distributor Administrative and Returns Fees Other Fees Total Balance at December 31, 2022 $ 3,336 $ 4,180 $ 25,801 $ 33,317 Provision 2,638 23,722 169,651 196,011 Payments/credits ( 1,198 ) ( 23,483 ) ( 168,118 ) ( 192,799 ) Balance at December 31, 2023 $ 4,776 $ 4,419 $ 27,334 $ 36,529 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 6. Commitments and Contingencies Leases As of December 31, 2023, we had an operating lease for 52,148 square feet of laboratory and office space in San Diego, California, with a lease term that expires on December 31, 2025 . In October 2021, we entered into a sublease agreement to sublet 23,873 square feet of laboratory and office space. The space was delivered to the subtenant in March 2022. As a result of the sublease agreement, our one 5 -year option to renew the lease on expiration applies only with respect to our remaining 28,275 square feet of laboratory and office space. In September 2023, we also entered into a sublease agreement to sublet 5,840 square feet of office space in Cary, North Carolina, with a lease term that expires on April 30, 2025 . Annual future minimum lease payments as of December 31, 2023 are as follows (in thousands): Year ended December 31: 2024 $ 3,153 2025 3,138 2026 — 2027 — 2028 — Thereafter — Total future minimum lease payments 6,291 Less: discount ( 416 ) Total lease liabilities $ 5,875 Rent expense under all operating leases totaled $ 2.9 million and $ 2.8 million for the years ended December 31, 2023 and 2022, respectively. During the years ended December 31, 2023 and 2022, we paid $ 3.0 million and $ 2.9 million, respectively, for our operating leases. Development Agreements We enter into agreements with clinical sites and clinical research organizations for the conduct of our clinical trials and contract manufacturing organizations for the manufacture and supply of preclinical, clinical and commercial materials and drug product. We make payments to these clinical sites and clinical research organizations based in part on the number of eligible patients enrolled and the length of their participation in the clinical trials. In some of our agreements with contract manufacturing organizations, we are required to meet minimum purchase obligations. Under certain of these agreements, we may be subject to penalties in the event that we prematurely terminate these agreements. At this time, due to the variability associated with clinical site agreements, contract research organization agreements and contract manufacturing agreements, we are unable to estimate with certainty the future costs we will incur. We intend to use our current financial resources to fund our obligations under these commitments. Purchase Obligations At December 31, 2023, purchase obligations primarily consisted of non-cancellable commitments with third-party manufacturers in connection with the manufacturing of our commercial products. Total purchase obligations of $ 60.2 million were not included in our consolidated financial statements for the year ended December 31, 2023, with $ 39.0 million due in one year and $ 21.2 million due within two to three years . |
Reorganization
Reorganization | 12 Months Ended |
Dec. 31, 2023 | |
Reorganizations [Abstract] | |
Reorganization | 7. Reorganization June 2023 Reorganization In June 2023, we implemented a restructuring plan under which we provided or will provide employees with one-time severance payments upon termination, continuation of benefits for a specific period of time, outplacement services and certain stock award modifications. The total amount expected to be incurred for these activities is $ 4.2 million, which primarily consists of severance payments to terminated employees. During the year ended December 31, 2023, we recognized $ 4.2 million of the total expense, $ 2.4 million of which was included in sales and marketing expense, $ 1.7 million of which was included in research and development expense and $ 0.1 million of which was included in general and administrative expense. As of December 31, 2023, we have paid $ 3.7 million of the total cash severance charges. We anticipate that the cash payments due to terminated employees will be substantially complete in the first quarter of 2024. Executive Officer Departures During the second and third quarters of 2023, we also implemented changes to our executive leadership structure. In connection with these changes, we provided five executive officers with one-time severance payments upon termination, continued benefits for a specified period of time, and certain stock award modifications. The total expense for these activities was $ 13.4 million, $ 4.7 million of which was primarily for severance and $ 8.7 million of which was for non-cash, stock-based compensation expense. During the year ended December 31, 2023, we recognized $ 13.4 million of the total expense, $ 7.2 million of which was included in general and administrative expense, $ 3.9 million of which was included in sales and marketing expense, and $ 2.3 million of which was included in research and development expense. As of December 31, 2023, we have paid substantially all of the cash severance charges. June 2022 Reorganization In June 2022, we implemented a restructuring plan under which we provided employees one-time severance payments upon termination, continuation of benefits for a specific period of time, outplacement services and certain stock award modifications. The total amount incurred for these activities was $ 5.4 million, $ 5.0 million of which was primarily for severance and $ 0.4 million of which was for non-cash, stock-based compensation expense related to stock award modifications. For the year ended December 31, 2022, we recognized $ 5.4 million of the total expense, $ 4.2 million of which was included in research and development expense, $ 1.0 million of which was included in sales and marketing expense, and $ 0.2 million of which was included in general and administrative expense. As of December 31, 2023, we have paid all of the total cash severance charges. We have accounted for these expenses in accordance with the FASB ASC Topic 420, Exit or Disposal Cost Obligations . |
Convertible Notes
Convertible Notes | 12 Months Ended |
Dec. 31, 2023 | |
Debt Disclosure [Abstract] | |
Convertible Notes | 8. Convertible Notes Working Capital Facility Agreement On August 9, 2023, we entered into a working capital facility agreement (the “Loan Agreement”) with Hercules Capital, Inc., as administrative agent and collateral agent, and the lenders party thereto (the “Lenders”). The Loan Agreement provides an aggregate principal amount of up to $ 50.0 million with tranched availability as follows: $ 25.0 million at closing (“tranche 1A”), $ 5.0 million available through December 15, 2024 (“tranche 1B”), and $ 20.0 million available from the earlier of: (1) the full draw of tranche 1B and (2) the expiration of tranche 1B, and available through December 15, 2025 (“tranche 1C”), and in the case of tranches 1B and 1C, subject to certain customary conditions to draw down. The Loan Agreement has a term of four years , with a springing maturity date that is 91 days prior to the stated maturity of our existing senior unsecured convertible notes (if still outstanding at such time). The loans thereunder do not have any scheduled amortization payments and accrue interest at a floating rate equal to, as of closing, 9.95 % per annum, payable in cash on a monthly basis and upon maturity or payoff. In addition, under the terms of the Loan Agreement, the loans also accrue paid-in-kind interest monthly at a fixed-rate of 1.5 % per annum which is due upon maturity or payoff. In addition, in connection with the tranche 1A funding, we issued warrants to the Lenders to purchase up to 297,619 shares of our common stock at an exercise price of $ 1.68 per share. The warrants are equal to 2.00 % of the principal amount of loans funded by the Lenders (the “Warrant Coverage”). The Loan Agreement also requires that we issue additional warrants to the Lenders at the time of each draw down of tranches 1B and 1C with the same Warrant Coverage. Each warrant is exercisable for seven years from the date of issuance. The Loan Agreement contains a minimum cash covenant, beginning on the closing date, requiring us to hold cash of no less than $ 8.5 million, if our market capitalization is less than $ 400 million. The Loan Agreement also contains customary representations and warranties and customary affirmative and negative covenants, including, among other things, restrictions on indebtedness, liens, investments, mergers, dispositions, prepayment of other indebtedness, and dividends and other distributions, subject to certain exceptions. We were in compliance with all covenants of the Loan Agreement as of December 31, 2023. The Loan Agreement was accounted for in accordance with ASC Topic 470, Debt , ASC Topic 480, Distinguishing Liabilities from Equity and ASC Topic 815, Derivatives and Hedging . The initial tranche 1A funding of $ 25.0 million and the warrants issued upon closing to purchase 297,619 shares of our common stock are accounted for as freestanding debt and equity financial instruments, respectively, as they are legally detachable and separately exercisable. The additional borrowings available under the Loan Agreement plus the additional warrants to purchase shares of our common stock, which would be issued concurrently, are accounted for as a single freestanding financial instrument that are not assets or obligations of ours; this financial instrument meets the loan commitment derivative scope exception and will be accounted for when and if we borrow additional tranches in the future. The initial funding of $ 25.0 million was recorded as a liability on the condensed consolidated balance sheets. In connection with the Loan Agreement, we recognized the initial 297,619 issued warrants at their relative fair value of $ 0.4 million, and we incurred debt issuance costs of $ 0.6 million, both of which were recorded as debt discounts. The debt discounts and the end of term fee, of $ 0.8 million, are being amortized and accreted into interest expense using the effective interest rate method over the term of the Loan Agreement, resulting in an effective interest rate of 14.5 %. For the year ended December 31, 2023, interest expense related to the Loan Agreement was $ 1.3 million, which included $ 1.0 million related to the stated interest rate, $ 0.2 million related to paid-in-kind interest, and $ 0.1 million related to the amortization of the debt discounts. As of December 31, 2023, the carrying value of tranche 1A was $ 24.3 million, which is comprised of the $ 25.2 million principal amount outstanding, less debt discounts of $ 0.9 million. Senior Unsecured Convertible Notes In May 2021, we entered into a note purchase agreement with funds affiliated with Baker Bros. Advisors LP for a private placement of $ 150.0 million in Senior Unsecured Convertible Notes (“Notes”). We received a total of $ 149.0 million, net of issuance costs, from the issuance of these Notes. The Notes were issued at par. The Notes bear interest at a rate of 1.5 % per annum, payable in cash semi-annually in arrears on June 15 th and December 15 th of each year, beginning on December 15, 2021 . The Notes mature on May 26, 2026 , unless earlier converted, redeemed or repurchased. The Notes will be subject to redemption at our option, between May 24, 2024 and May 24, 2025, but only if the last reported sale price per share of our common stock exceeds 250 % of the conversion price for a specified period of time, or on or after May 24, 2025 if the last reported sale price per share of our common stock exceeds 200 % of the conversion price for a specified period of time. The redemption price will be equal to the principal amount of the Notes to be redeemed, plus accrued and unpaid interest. Upon conversion, we will settle the Notes in shares of our common stock. The initial conversion rate for the Notes is 65.4620 shares per $ 1,000 principal amount of the Notes (equivalent to an initial conversion price of $ 15.276 per share of common stock). If a holder of the Notes converts upon a make-whole fundamental change or company redemption, the holder may be eligible to receive a make-whole premium through an increase to the conversion rate. In May 2021, we filed a registration statement with the SEC to register for resale 12.4 million shares of our common stock underlying the Notes, including the maximum number of shares of common stock issuable under the make-whole premium. The Notes were accounted for in accordance with ASC Subtopic 470-20, Debt with Conversion and Other Options (“ASC 470-20”) and ASC Subtopic 815-40, Contracts in Entity’s Own Equity (“ASC 815-40”). Under ASC 815-40, to qualify for equity classification (or non-bifurcation, if embedded), the instrument (or embedded feature) must be both (1) indexed to the issuer’s stock and (2) meet the requirements of the equity classification guidance. Based upon our analysis, it was determined that the Notes do contain embedded features indexed to our own stock, but do not meet the requirements for bifurcation, and therefore do not need to be separately accounted for as an equity component. Since the embedded conversion feature meets the equity scope exception from derivative accounting, and, also since the embedded conversion option does not need to be separately accounted for as an equity component under ASC 470-20, the proceeds received from the issuance of the Notes were recorded as a liability on the consolidated balance sheets. We incurred issuance costs related to the Notes of $ 1.0 million, which we recorded as debt issuance costs and are included as a reduction to the Notes on the consolidated balance sheets. The debt issuance costs are being amortized to interest expense using the effective interest rate method over the term of the Notes, resulting in an effective interest rate of 1.6 %. For the year ended December 31, 2023, interest expense related to the Notes was $ 2.5 million, which included $ 2.3 million related to the stated interest rate and $ 0.2 million related to the amortization of debt issuance costs. As of December 31, 2023, the carrying value of the Notes was $ 149.5 million, which is comprised of the $ 150.0 million principal amount of the Notes outstanding, less debt issuance costs of $ 0.5 million. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2023 | |
Equity [Abstract] | |
Stockholders' Equity | 9. Stockholders’ Equity 2023 Private Placement On July 21, 2023, we entered into a Securities Purchase Agreement (the “July 2023 Private Placement”) with Rubric Capital Management L.P., Velan Capital, Clearline Capital and Hercules Capital, Inc. (collectively, the “Purchasers”) whereby we sold 20.7 million shares of our common stock in a private placement at a purchase price of $ 1.37 per share. In addition, as a component of the July 2023 Private Placement, we sold 1.2 million pre-funded warrants to purchase shares of our common stock at a purchase price of $ 1.3699 per share. The pre-funded warrants have an exercise price of $ 0.0001 per share. The total net proceeds from the sale of the common stock and pre-funded warrants is $ 29.8 million (net of $ 0.2 million in issuance costs). The July 2023 Private Placement closed on July 25, 2023. In August 2023, we filed a registration statement with the SEC to register for resale 21.9 million shares of our common stock. The registration statement was declared effective on August 31, 2023. 2022 Private Placement On August 8, 2022, we entered into an agreement to sell 16.1 million shares of our common stock in a private placement at a purchase price of $ 3.10 per share (“2022 Private Placement”). In addition, as a component of the 2022 Private Placement, we agreed to sell 8.5 million pre-funded warrants to purchase shares of our common stock at a purchase price of $ 3.0999 per share. The pre-funded warrants have an exercise price of $ 0.0001 per share. The total net proceeds from the sale of the common stock and pre-funded warrants was $ 75.1 million (net of $ 1.4 million in issuance costs). The 2022 Private Placement closed on August 10, 2022. In October 2022, we filed a registration statement with the SEC to register for resale 24.6 million shares of our common stock. The registration statement was declared effective on October 18, 2022. Common Stock Reserved for Future Issuance Shares of our common stock reserved for future issuance as of December 31, 2023 were as follows (in thousands): Number of Shares Stock options outstanding 24,575 Restricted stock units outstanding 1,405 Stock options available for grant 8,605 Shares of common stock reserved under the Employee Stock Purchase Plan 328 Shares of common stock underlying warrants 1,461 Shares of common stock underlying convertible notes outstanding (see Note 8) 9,819 Total shares reserved for future issuance 46,193 |
Equity Incentive Plans
Equity Incentive Plans | 12 Months Ended |
Dec. 31, 2023 | |
Equity [Abstract] | |
Equity Incentive Plans | 10. Equity Incentive Plans Employee Stock Purchase Plan In 1997, our stockholders approved our Employee Stock Purchase Plan (“ESPP”) at which time a maximum of 10,000 shares of common stock were available for issuance. In December 2007, May 2009, June 2011, May 2014, May 2015, June 2016, June 2017, June 2019, June 2021, May 2022 and June 2023, our stockholders authorized increases in the number of shares reserved for issuance under the ESPP by 5,000 , 10,000 , 25,000 , 25,000 , 100,000 , 100,000 , 200,000 , 300,000 , 200,000, 850,000 and 400,000 shares, respectively, for a total of 2,225,000 shares reserved at December 31, 2023. Under the terms of the ESPP, employees can elect to have up to a maximum of 10 % of their base earnings withheld to purchase shares of our common stock. The purchase price of the stock is 85 % of the lower of the closing prices for our common stock on either: (i) the first trading day in the enrollment period, as defined in the ESPP, in which the purchase is made, or (ii) the purchase date. The length of the enrollment period is 6 months. Enrollment dates are the first business day of May and November. Under the ESPP, we issued 717,046 and 406,421 shares in 2023 and 2022, respectively. The weighted-average exercise price per share of the purchase rights exercised during 2023 and 2022 was $ 1.26 and $ 3.55 , respectively. As of December 31, 2023, 1,897,445 shares of common stock have been issued under the ESPP and 327,555 shares of common stock are available for future issuance. Stock Option Plans We currently have one stock option plan from which we can grant options and restricted stock awards to employees, officers, directors and consultants. In December 2007, the stockholders approved our 2007 Amended and Restated Equity Incentive Plan (“2007 Plan”) at which time a maximum of 150,000 shares of common stock were available for grant. In May 2010, June 2011, May 2014, May 2015, June 2016, June 2017, June 2019, June 2021, May 2022 and June 2023, our stockholders approved amendments to our 2007 Plan to increase the maximum number of shares of common stock available for grant by 100,000 , 4,500,000 , 1,750,000 , 4,300,000 , 3,000,000 , 5,000,000 , 7,000,000 , 2,000,000, 2,900,000 and 8,490,000 shares of common stock, respectively, resulting in an aggregate of 39,190,000 shares of common stock authorized for issuance as of December 31, 2023. At December 31, 2023, there were 8,605,026 shares available for future grant under the 2007 Plan. Any shares that are issuable on exercise of options granted that expire, are cancelled or that we receive pursuant to a net exercise of options are available for future grant and issuance. In 2023, we granted options to certain employees outside of our stockholder approved stock option plan. All options to purchase our common stock were granted with an exercise price that equals fair market value of the underlying common stock on the grant dates and expire no later than 10 years from the date of grant. The options are exercisable in accordance with vesting schedules that generally provide for them to be fully vested and exercisable 4 years after the date of grant, provided, however, that we have also issued stock options awards that are subject to market-based vesting requirements. All stock option grants issued outside of our stockholder approved plans were approved by our Board of Directors and have been registered on Form S-8 with the SEC. In 2020, we began granting restricted stock units (“RSUs”) to employees and non-employee directors pursuant to the 2007 Plan. We satisfy such grants through the issuance of new shares upon vesting. The following summarizes the stock option plan activity: Outstanding Options Weighted- Average Number of Exercise Shares Price Balance at December 31, 2022 20,749,349 $ 14.61 Granted 16,210,379 $ 1.69 Exercised ( 26,570 ) $ 1.32 Cancelled ( 12,358,296 ) $ 12.72 Balance at December 31, 2023 24,574,862 $ 7.06 Outstanding RSUs Weighted- Average Number of Grant Date Shares Fair Value Balance at December 31, 2022 3,167,397 $ 6.46 Granted 1,757,506 $ 2.39 Released ( 1,627,619 ) $ 6.34 Forfeited ( 1,892,355 ) $ 4.27 Balance at December 31, 2023 1,404,929 $ 4.43 For the year ended December 31, 2023, options cancelled (included in options outstanding) consisted of 11,508,070 options forfeited with a weighted-average exercise price of $ 13.10 and 850,226 options expired with a weighted-average exercise price of $ 7.47 . As of December 31, 2023, options exercisable have a weighted-average remaining contractual term of 5.6 years. The total intrinsic value of stock option exercises, which is the difference between the exercise price and closing price of our common stock on the date of exercise, during the year ended December 31, 2023 was $ 10,000 . There were no option exercises during the year ended December 31, 2022. As of December 31, 2023, the total intrinsic value of options outstanding and exercisable was $ 137,000 . As of December 31, 2022, there were no options outstanding and exercisable that were in-the-money. Years Ended December 31, 2023 2022 Weighted- Weighted- Average Average Exercise Exercise Options Price Options Price Exercisable at end of year 11,390,275 $ 12.87 13,650,210 $ 17.86 Options vested or expected to 24,574,862 $ 7.06 20,183,769 $ 14.82 Exercise prices and weighted-average remaining contractual lives for the options outstanding as of December 31, 2023 were: Weighted- Weighted- Average Average Weighted- Exercise Remaining Average Price of Outstanding Range of Contractual Exercise Options Options Options Exercise Prices Life (in years) Price Exercisable Exercisable 6,179,628 $ 0.97 –$ 1.51 9.51 $ 1.25 344,006 $ 1.30 7,660,800 $ 1.52 –$ 2.28 9.28 1.77 2,001,281 1.78 3,406,724 $ 2.32 –$ 3.48 7.68 2.99 2,182,510 3.05 83,323 $ 3.61 –$ 5.42 8.61 4.08 34,239 4.09 21,459 $ 5.50 –$ 8.25 7.65 5.84 10,059 5.81 1,100,494 $ 8.80 –$ 13.20 3.57 11.18 996,018 11.20 3,116,010 $ 13.50 –$ 20.25 4.13 16.10 2,817,050 16.16 2,828,424 $ 20.93 –$ 31.40 4.26 25.72 2,827,112 25.72 178,000 $ 31.45 –$ 41.18 3.17 35.45 178,000 35.45 24,574,862 7.58 7.06 11,390,275 12.87 On December 31, 2023, we had reserved 25,979,791 shares of common stock for future issuance on exercise of outstanding options and vesting of outstanding restricted stock units granted under the 2007 Plan, as well as the non-plan grants. Stock-Based Compensation The following summarizes stock-based compensation expense related to stock-based payment awards pursuant to our equity compensation arrangements (in thousands): December 31, 2023 2022 Research and development $ 10,880 $ 17,909 General and administrative 12,471 11,688 Sales and marketing 9,503 13,383 Total stock-based compensation expense $ 32,854 $ 42,980 As of December 31, 2023, there was $ 23.2 million of total unrecognized compensation cost related to non-vested, stock-based payment awards granted under all of our equity compensation plans and all non-plan option grants. Total unrecognized compensation cost will be adjusted for future changes in estimated forfeitures. We expect to recognize this compensation cost over a weighted-average period of three years . The fair value of RSUs is estimated based on the closing market price of our common stock on the date of the grant. RSUs generally vest quarterly over a four-year period. We estimated the fair value of each option grant and ESPP purchase right on the date of grant using the Black-Scholes option pricing model with the following weighted-average assumptions: Options: December 31, 2023 2022 Risk-free interest rate 3.7 % 3.3 % Dividend yield — % — % Volatility 68.1 % 62.0 % Expected life (years) 6 to 10 6 ESPP: December 31, 2023 2022 Risk-free interest rate 5.3 % 3.2 % Dividend yield — % — % Volatility 99.6 % 83.8 % Expected life (months) 6 6 The weighted-average fair value of options granted was $ 1.13 and $ 1.71 for the years ended December 31, 2023 and 2022, respectively. The weighted-average fair value of shares purchased through the ESPP was $ 0.64 and $ 1.65 for the years ended December 31, 2023 and 2022, respectively. The risk-free interest rate assumption is based on observed interest rates on U.S. Treasury debt securities with maturities close to the expected term of our employee and director stock options and ESPP purchases. The dividend yield assumption is based on our history and expectation of dividend payouts. We have never paid dividends on our common stock, and we do not anticipate paying dividends in the foreseeable future. We used our historical stock price to estimate volatility. The expected life of employee and director stock options represents the average of the contractual term of the options and the weighted-average vesting period, as permitted under the simplified method. We have elected to use the simplified method, as we do not have enough historical exercise experience to provide a reasonable basis on which to estimate the expected term. The expected life for the ESPP purchase rights is 6 months, which represents the length of each purchase period. |
Employee Benefit Plan
Employee Benefit Plan | 12 Months Ended |
Dec. 31, 2023 | |
Retirement Benefits [Abstract] | |
Employee Benefit Plan | 11. Employee Benefit Plan We have a defined contribution 401(k) plan (“Plan”) covering substantially all of our employees. We make matching cash contributions equal to 50 % of each participant’s contribution during the Plan year up to a maximum amount equal to the lesser of 3 % of each participant’s annual compensation or $ 9,900 and $ 9,150 for the years ended December 31, 2023 and 2022, respectively. Such amounts were recorded as expense in the corresponding years. We may also contribute additional discretionary amounts to the Plan as we determine. For the years ended December 31, 2023 and 2022, we contributed $ 1.0 million and $ 1.4 million, respectively, to the Plan. No discretionary contributions have been made to the Plan since its inception. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 12. Income Taxes For the years ended December 31, 2023 and 2022, we did not record a provision for income taxes due to a full valuation allowance against our deferred tax assets. The difference between the provision for income taxes and income taxes computed using the effective U.S. federal statutory rate is as follows (in thousands): December 31, 2023 2022 Tax at statutory federal rate $ ( 23,210 ) $ ( 38,225 ) State tax, net of federal benefit ( 1,460 ) ( 13,898 ) Research and development credits — ( 3,531 ) Stock-based compensation expense 19,022 5,857 Non-deductible compensation ( 4,682 ) 2,104 Employee retention credit adjustment — ( 1,265 ) Change in valuation allowance 7,556 46,452 Provision to return adjustment 3,008 — Other ( 234 ) 2,506 Provision for income taxes $ — $ — Deferred income tax assets and liabilities arising from differences between accounting for financial statement purposes and tax purposes, less valuation allowance at year-end are as follows (in thousands): December 31, 2023 2022 Deferred tax assets: Net operating loss carryforward $ 320,998 $ 313,834 Research and development credits 59,417 60,245 Section 174 capitalized research and development 28,822 20,903 Stock-based compensation 15,413 23,991 Lease liabilities 1,471 2,052 Other 5,005 3,693 Total gross deferred tax assets 431,126 424,718 Deferred tax liabilities: Right-of-use lease assets ( 1,362 ) ( 1,914 ) Total gross deferred tax liabilities ( 1,362 ) ( 1,914 ) Valuation allowance ( 429,764 ) ( 422,804 ) Net deferred tax assets $ — $ — We have established a valuation allowance to offset net deferred tax assets as of December 31, 2023 and 2022 due to the uncertainty of realizing future tax benefits from such assets. As of December 31, 2023, we had federal and state net operating loss (“NOL”) carryforwards of $ 1.3 billion and $ 879.1 million, respectively. The federal NOL carryforwards consist of $ 542.3 million generated before January 1, 2018, which will begin to expire in 2024 , and $ 755.7 million that can be carried forward indefinitely, but are subject to the 80 % taxable income limitation. The state NOL carryforwards will begin to expire in 2028 . As of December 31, 2023, we had federal and state research and development credit carryforwards of $ 44.6 million and $ 21.7 million, respectively. The federal research and development credit carryforwards will begin to expire in 2024 . The state research and development credit carryforwards will be carried forward indefinitely. Internal Revenue Code (“IRC”) Sections 382 and 383 place a limitation on the amount of taxable income that can be offset by NOL and credit carryforwards after a change in control (generally greater than 50% change in ownership within a three-year period) of a loss corporation. Generally, after a change in control, a loss corporation cannot deduct NOL and credit carryforwards in excess of the IRC Sections 382 and 383 limitation. State jurisdictions have similar rules. We have performed an analysis of IRC Sections 382 and 383 through July 31, 2023 and determined there were ownership changes in 2007, 2011 and 2013. The limitation in the federal and state NOL and research and development credit carryforwards that expire unused would reduce the deferred tax assets, which are fully offset by a valuation allowance. We file U.S. and state income tax returns with varying statutes of limitations. The tax years from 2003 to 2023 remain open to examination due to the carryover of unused NOL carryforwards and tax credits. A reconciliation of our unrecognized tax benefits is as follows (in thousands): Year Ended December 31, 2023 2022 Balance at beginning of year $ 11,235 $ 9,631 Decrease for tax positions of prior years ( 332 ) ( 200 ) Increase based on tax positions related to current year — 1,804 Balance at end of year $ 10,903 $ 11,235 Due to our valuation allowance, the $ 10.9 million of unrecognized tax benefits would not affect the effective tax rate, if recognized. It is the Company’s practice to recognize interest and penalties related to income tax matters in income tax expense. As of December 31, 2023, we had no accrued interest and penalties related to uncertain tax positions. We do not expect any material changes to the estimated amount of liability associated with our uncertain tax positions within the next 12 months. On March 27, 2020, the Coronavirus Aid, Relief and Economic Security Act (“CARES Act”) was enacted and signed into law in response to the COVID-19 pandemic. The CARES Act includes changes to the tax provisions that benefits business such as the Employee Retention Credit (“ERC”). The ERC provides an eligible employer with a tax credit that is allowed against certain employment taxes. We qualified for federal government assistance through the ERC provisions for the period between January 1, 2021 and September 30, 2021. We recognize government grants when there is reasonable assurance of compliance with grant conditions and receipt of the credits. For the year ended December 31, 2022, we recorded a one-time refund totaling $ 6.0 million, which was included in the consolidated balance sheets as prepaid expenses and other current assets, as well as in the consolidated statements of operations and comprehensive loss as an offset to the related employee expenses within research and development, general and administrative, and sales and marketing expenses. The one-time $ 6.0 million refund was received in the second quarter of 2023. Beginning January 1, 2022, the Tax Cuts and Jobs Act (the “Tax Act”) eliminated the option to deduct research and development expenditures in the current year and requires taxpayers to capitalize such expenses pursuant to IRC Section 174. The capitalized expenses are amortized over a 5-year period for domestic expenses and over a 15-year period for foreign expenses. As a result of this provision of the Tax Act, deferred tax assets related to capitalized research expenses increased by $ 21 million during the year ended December 31, 2022. |
Subsequent Event
Subsequent Event | 12 Months Ended |
Dec. 31, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Event | 13. Subsequent Event In January 2024, we entered into a five-year distributor partnership with CrossLink Life Sciences, LLC (“Crosslink ” ) to expand the sales network supporting ZYNRELEF. Crosslink will be the lead partner in the U.S. to expand ZYNRELEF promotion for orthopedic indications. The partnership will launch in several phases, initially at a regional level, followed by an expanded national rollout. In total, approximately 650 representatives will be added to Heron ’ s sales network over the year. At this time, we cannot estimate the impact of the Crosslink agreement on our future financial results. |
Summary of Significant Account
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Principles of Consolidation | Principles of Consolidation The accompanying consolidated financial statements include the accounts of Heron Therapeutics, Inc. and its wholly-owned subsidiary, Heron Therapeutics B.V., which was organized in the Netherlands in March 2015. Heron Therapeutics B.V. has no operations and no material assets or liabilities, and there have been no significant transactions related to Heron Therapeutics B.V. since its inception. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with generally accepted accounting principles in the U.S. (“GAAP”) requires management to make estimates and assumptions that affect the amounts reported in the financial statements and disclosures made in the accompanying notes to the financial statements. Our significant accounting policies that involve significant judgment and estimates include revenue recognition, investments, inventory and the related reserves, accrued clinical and manufacturing liabilities, income taxes and stock-based compensation. Actual results could differ materially from those estimates. |
Cash, Cash Equivalents and Short-term Investments | Cash, Cash Equivalents and Short-term Investments Cash and cash equivalents consist of cash and highly liquid investments with contractual maturities of three months or less from the original purchase date. Short-term investments consist of securities with contractual maturities of greater than three months from the original purchase date. Securities with contractual maturities greater than one year are classified as short-term investments on the consolidated balance sheets, as we have the ability, if necessary, to liquidate these securities to meet our liquidity needs in the next 12 months. We have classified our short-term investments as available-for-sale securities in the accompanying consolidated financial statements. Available-for-sale securities are stated at fair market value, with net changes in unrealized gains and losses reported in other comprehensive loss and realized gains and losses included in other income (expense), net. The cost of securities sold is based on the specific identification method. Interest and dividends on securities classified as available-for-sale are included in interest income within other income (expense), net. Our bank and investment accounts have been placed under a control agreement in accordance with our working capital line of credit (see Note 8). |
Fair Value of Financial Instruments | Fair Value of Financial Instruments A company may elect to use fair value to measure accounts receivable, available-for-sale securities, accounts payable, guarantees and issued debt, among others. If the use of fair value is elected, any upfront costs and fees related to the item such as debt issuance costs must be recognized in earnings and cannot be deferred. The fair value election is irrevocable and generally made on an instrument-by-instrument basis, even if a company has similar instruments that it elects not to measure based on fair value. Unrealized gains and losses on existing items for which fair value has been elected are reported as a cumulative adjustment to beginning retained earnings and any changes in fair value are recognized in earnings. We have elected to not apply the fair value option to our financial assets and liabilities. Financial instruments, including cash and cash equivalents, receivables, inventory, prepaid expenses, other current assets, accounts payable and accrued expenses, are carried at cost, which is considered to be representative of their respective fair values because of the short-term maturity of these instruments. Short-term available-for-sale investments are carried at fair value. Our convertible notes and non-current notes payable outstanding at December 31, 2023 and 2022 do not have a readily available ascertainable market value, however, their carrying value, which is measured at carrying value less unamortized debt issuance costs or debt discounts, is considered to approximate their fair value. |
Concentration of Credit Risk | Concentration of Credit Risk Cash, cash equivalents and short-term investments are financial instruments that potentially subject us to concentrations of credit risk. We deposit our cash in financial institutions. At times, such deposits may be in excess of insured limits. We have not experienced any losses in such accounts and believe we are not exposed to significant risk on our cash, cash equivalents and short-term investments. Any loss incurred or a lack of access to such funds could have a significant adverse impact on our financial condition, results of operations, and cash flows. We may also invest our excess cash in money market funds, U.S. government and agencies, corporate debt securities and commercial paper. We have established guidelines relative to our diversification of our cash investments and their maturities in an effort to maintain safety and liquidity. These guidelines are periodically reviewed and modified to take advantage of trends in yields and interest rates. ZYNRELEF, APONVIE, CINVANTI and SUSTOL (collectively, our “Products”) are distributed in the U.S. through a limited number of specialty distributors and full line wholesalers (collectively, “Customers”) that resell to healthcare providers and hospitals, the end users of our Products. The following includes the percentage of net product sales and accounts receivable balances for our three major Customers, each of which comprised 10% or more of our net product sales: Net Product Accounts Year Ended As of Customer A 43.3 % 42.1 % Customer B 36.8 % 36.1 % Customer C 19.0 % 21.5 % Total 99.1 % 99.7 % |
Accounts Receivable, Net | Accounts Receivable, Net Accounts receivable are recorded at the invoice amount, net of an allowance for credit losses. The allowance for credit losses reflects accounts receivable balances that are believed to be uncollectible. In estimating the allowance for credit losses, we consider: (1) our historical experience with collections and write-offs; (2) the credit quality of our Customers and any recent or anticipated changes thereto; (3) the outstanding balances and past due amounts from our Customers; and (4) reasonable and supportable forecast of economic conditions expected to exist throughout the contractual term of the receivable. As of December 31, 2023 and 2022, we determined that an allowance for credit losses was not required. For the years ended December 31, 2023 and 2022, we did not have any material write-offs of accounts receivable balances. |
Inventory | Inventory Inventory is stated at the lower of cost or estimated net realizable value on a first-in, first-out, or FIFO, basis. We periodically analyze our inventory levels and write down inventory that has become obsolete, inventory that has a cost basis in excess of its estimated realizable value and inventory quantities that are in excess of expected sales requirements as cost of product sales. The determination of whether inventory costs will be realizable requires estimates by management. If actual market conditions are less favorable than projected by management, additional write-downs of inventory may be required, which would be recorded as cost of product sales. |
Property and Equipment | Property and Equipment Property and equipment is stated at cost less accumulated depreciation and amortization. Depreciation is calculated on a straight-line basis over the estimated useful lives of the assets (generally 5 years ). Leasehold improvements are stated at cost and amortized on a straight-line basis over the shorter of the estimated useful life of the asset or the lease term. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets If indicators of impairment exist, we assess the recoverability of the affected long-lived assets by determining whether the carrying value of such assets can be recovered through undiscounted future operating cash flows. If impairment is indicated, we measure the amount of such impairment by comparing the carrying value of the asset to the fair value of the asset and record the impairment as a reduction in the carrying value of the related asset with a corresponding charge to operating expenses. Estimating the undiscounted future operating cash flows associated with long-lived assets requires judgment and assumptions that could differ materially from actual results. |
Leases | Leases We determine if an arrangement is a lease or contains lease components at inception. Operating leases with an initial term greater than 12 months are recorded as lease liabilities with corresponding right-of-use (“ROU”) lease assets on the consolidated balance sheets. ROU lease assets represent our right to use the underlying assets over the lease term, and lease liabilities represent the present value of our obligation to make lease payments arising from the lease. Lease liabilities are recognized at the lease commencement based on the present value of lease payments over the lease term. As most of our leases do not provide an implicit rate, we use our incremental borrowing rate based on the information available at the commencement date in determining the present value of lease payments. We use the implicit rate when readily determinable. The ROU lease assets equal the lease liabilities, less unamortized lease incentives, unamortized initial direct costs and the cumulative difference between rent expense and amounts paid under the lease. The lease term includes any option to extend or terminate the lease when it is reasonably certain that we will exercise that option. Lease expense is recognized on a straight-line basis over the lease term. We have elected the practical expedient to not separate lease and non-lease components. |
Revenue Recognition | Revenue Recognition Revenue is recognized in accordance with the Financial Accounting Standards Board (the “FASB”) Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers (“Topic 606”). Topic 606 is based on the principle that revenue should be recognized to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. Product Sales Our Products are distributed in the U.S. through a limited number of Customers that resell to healthcare providers and hospitals, the end users of our Products. Revenue is recognized in an amount that reflects the consideration we expect to receive in exchange for our Products. To determine revenue recognition for contracts with customers within the scope of Topic 606, we perform the following 5 steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations of the contract(s); (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract(s); and (v) recognize revenue when (or as) we satisfy the performance obligations. We recognize revenue from product sales when there is a transfer of control of the product to our Customers. We typically determine transfer of control based on when the product is delivered, and title passes to our Customers. Product Sales Allowances We recognize product sales allowances as a reduction of product sales in the same period the related revenue is recognized. Product sales allowances are based on amounts owed or to be claimed on the related sales. Such variable consideration includes estimates that take into consideration the terms of our agreements with Customers, historical product returns, rebates or discounts taken, the shelf life of the product and specific known market events, such as competitive pricing and new product introductions. If actual future results vary from our estimates, we may need to adjust these estimates, which could have an effect on product sales and earnings in the period of adjustment. Our product sales allowances include: • Product Returns—We allow our Customers to return product for credit beginning three months prior to the product expiration date and up to 12 months after the product expiration date. As such, there may be a significant period of time between the time the product is shipped and the time the credit is issued on returned product. • Distributor Fees—We pay distribution service fees to our Customers based on a contractually fixed percentage of the wholesale acquisition cost and fees for data. These fees are paid no later than two months after the quarter in which product was shipped. • Group Purchasing Organization (“GPO”) Discounts and Rebates—We offer cash discounts to GPO members. These discounts are taken when the GPO members purchase product from our Customers, who then charge back to us the discount amount. Additionally, we offer volume and contract-tier rebates to GPO members. Rebates are based on actual purchase levels during the quarterly rebate purchase period. • GPO Administrative Fees—We pay administrative fees to GPOs for services and access to data. These fees are based on contracted terms and are paid after the quarter in which the product was purchased by the GPOs’ members. • Medicaid Rebates—We participate in Medicaid rebate programs, which provide assistance to certain low-income patients based on each individual state’s guidelines regarding eligibility and services. Under the Medicaid rebate programs, we pay a rebate to each participating state, generally within six months after the quarter in which the product was sold. • Prompt Pay Discounts—We may provide discounts on product sales to our Customers for prompt payment based on contractual terms. We believe our estimated allowance for product returns and GPO discounts requires a high degree of judgment and is subject to change based on our experience and certain quantitative and qualitative factors. We believe our estimated allowances for distributor fees, GPO rebates and administrative fees, Medicaid rebates and prompt pay discounts do not require a high degree of judgment because the amounts are settled within a relatively short period of time. Our product sales allowances and related accruals are evaluated each reporting period and adjusted when trends or significant events indicate that a change in estimate is appropriate. Changes in product sales allowance estimates could materially affect our results of operations and financial position. |
Accrued Clinical Liabilities | Accrued Clinical Liabilities We accrue clinical costs based on work performed, which relies on estimates of the progress of the trials and the related expenses incurred. Clinical trial related contracts vary significantly in duration, and may be for a fixed amount, based on the achievement of certain contingent events or deliverables, a variable amount based on actual costs incurred, capped at a certain limit or contain a combination of these elements. Revisions are recorded to research and development expense in the period in which the facts that give rise to the revision become known. Historically, revisions have not resulted in material changes to research and development expense; however, a modification in the protocol of a clinical trial or cancellation of a clinical trial could result in a material charge to our results of operations. |
Research and Development Expense | Research and Development Expense All costs of research and development are expensed in the period incurred. Research and development expense primarily consists of personnel and related costs, stock-based compensation expense, fees paid to outside service providers and consultants, facilities costs and materials used in clinical and preclinical trials and research and development. |
Patent Costs | Patent Costs We incur outside legal fees in connection with filing and maintaining our various patent applications. All patent costs are expensed as incurred and are included in general and administrative expense in the consolidated statements of operations and comprehensive loss. |
Stock-Based Compensation Expense | Stock-Based Compensation Expense We estimate the fair value of each option grant using the Black-Scholes option pricing model and for market-based stock option grants using the Monte Carlo simulation model. This fair value is then amortized using the straight-line single-option method of attributing the value of stock-based compensation to expense over the requisite service periods of the awards. Forfeitures are accounted for, as incurred, as a reversal of stock-based compensation expense related to awards that will not vest. The Black-Scholes option pricing model and the Monte Carlo simulation model both require inputs of complex and subjective assumptions, including each option’s expected life and price volatility of the underlying stock. |
Warrants | Warrants We have issued warrants to purchase shares of our common stock in conjunction with certain equity and debt financings or in exchange for services. The terms of the warrants were evaluated to determine the appropriate classification as equity or a liability. |
Income Taxes | Income Taxes We recognize the impact of a tax position in our consolidated financial statements if the position is more likely than not to be sustained on examination and on the technical merits of the position. The total amount of unrecognized tax benefits, if recognized, would affect other tax accounts, primarily deferred taxes in future periods, and would not affect our effective tax rate, since we maintain a full valuation allowance against our deferred tax assets (see Note 12). We recognize interest and penalties related to income tax matters in income tax expense. |
Comprehensive Loss | Comprehensive Loss Comprehensive loss is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources. Net changes in unrealized gains and losses on available-for-sale securities are included in other comprehensive income (loss) and represent the difference between our net loss and comprehensive loss for both periods presented. |
Net Loss per Share | Net Loss per Share Basic net loss per share is calculated by dividing the net loss by the weighted-average number of common shares outstanding for the period, including pre-funded warrants to purchase shares of common stock. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of common shares and common stock equivalents outstanding for the period determined using the treasury stock method. For purposes of this calculation, stock options, restricted stock units, warrants and shares of common stock underlying convertible notes are considered to be common stock equivalents and are included in the calculation of diluted net loss per share only when their effect is dilutive. Because we have incurred a net loss for both periods presented in the consolidated statements of operations and comprehensive loss, the following common stock equivalents were not included in the computation of net loss per share because their effect would be anti-dilutive (in thousands): December 31, 2023 2022 Stock options outstanding 24,575 20,749 Restricted stock units outstanding 1,405 3,167 Warrants outstanding 298 8,548 Shares of common stock underlying convertible notes outstanding 9,819 9,819 |
Segment Reporting | Segment Reporting Management has determined that we operate in one business segment which is the development and commercialization of therapeutic innovations. All revenues for the years ended December 31, 2023 and 2022 were generated from customers in the U.S. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements Not Yet Adopted In December 2023, FASB issued Accounting Standards Update No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”), to enhance income tax reporting disclosures and require disclosure of specific categories in the tabular rate reconciliation. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024, on a prospective basis. Early adoption and retrospective application are permitted. We are currently evaluating the impact on our disclosures. |
Summary of Significant Accou_2
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Percentage of Net Product Sales and Accounts Receivable Balance | The following includes the percentage of net product sales and accounts receivable balances for our three major Customers, each of which comprised 10% or more of our net product sales: Net Product Accounts Year Ended As of Customer A 43.3 % 42.1 % Customer B 36.8 % 36.1 % Customer C 19.0 % 21.5 % Total 99.1 % 99.7 % |
Common Stock Equivalents Excluded From Computation of Net Loss Per Share | Because we have incurred a net loss for both periods presented in the consolidated statements of operations and comprehensive loss, the following common stock equivalents were not included in the computation of net loss per share because their effect would be anti-dilutive (in thousands): December 31, 2023 2022 Stock options outstanding 24,575 20,749 Restricted stock units outstanding 1,405 3,167 Warrants outstanding 298 8,548 Shares of common stock underlying convertible notes outstanding 9,819 9,819 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis | We measure cash, cash equivalents and short-term investments at fair value on a recurring basis. The fair values of such assets were as follows (in thousands): Fair Value Measurements at Reporting Date Using Balance at Quoted Significant Significant Cash and money market funds $ 23,441 $ 23,441 $ — $ — U.S. treasury bills and government agency obligations 31,636 31,636 — — U.S. corporate debt securities 16,889 — 16,889 — Foreign corporate debt securities 5,460 — 5,460 — U.S. commercial paper 1,990 — 1,990 — Foreign commercial paper 993 — 993 — Total $ 80,409 $ 55,077 $ 25,332 $ — Fair Value Measurements at Reporting Date Using Balance at Quoted Significant Significant Cash and money market funds $ 13,867 $ 13,867 $ — $ — U.S. treasury bills and agency obligations 35,715 35,715 — — U.S. corporate debt securities 1,497 — 1,497 — U.S. commercial paper 5,481 — 5,481 — Foreign commercial paper 28,292 — 28,292 — Total $ 84,852 $ 49,582 $ 35,270 $ — |
Balance Sheet Details (Tables)
Balance Sheet Details (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Summary of Short-Term Investments | The following is a summary of our short-term investments (in thousands): December 31, 2023 Amortized Gross Gross Estimated U.S. treasury bills and government agency obligations $ 31,625 $ 11 $ — $ 31,636 U.S. corporate debt securities 11,652 1 — 11,653 Foreign corporate debt securities 5,459 1 — 5,460 U.S. commercial paper 1,991 — ( 1 ) 1,990 Foreign commercial paper 993 — — 993 Total $ 51,720 $ 13 $ ( 1 ) $ 51,732 December 31, 2022 Amortized Gross Gross Estimated U.S. treasury bills and agency obligations $ 35,734 $ — $ ( 19 ) $ 35,715 U.S. commercial paper 5,481 — — 5,481 Foreign commercial paper 28,292 — — 28,292 Total $ 69,507 $ — $ ( 19 ) $ 69,488 |
Schedule of Inventory | Inventory consists of the following (in thousands): December 31, 2023 2022 Raw materials $ 17,643 $ 15,137 Work in process 14,550 20,723 Finished goods 9,917 18,713 Total inventory $ 42,110 $ 54,573 |
Schedule of Prepaid Expenses and Other Assets | Prepaid expenses and other assets consist of the following (in thousands): December 31, 2023 2022 Prepaid expenses $ 11,731 $ 21,120 Prepaid insurance 1,910 1,947 Interest receivables 310 154 Deposits 274 254 Other receivables 21 6,197 Total prepaid expenses and other assets $ 14,246 $ 29,672 |
Schedule of Property and Equipment, Net | Property and equipment, net consists of the following (in thousands): December 31, 2023 2022 Scientific equipment $ 34,027 $ 33,318 Leasehold improvements 647 647 Computer equipment and software 1,506 1,506 Furniture, fixtures and office equipment 1,014 982 Property and equipment, gross 37,194 36,453 Less: accumulated depreciation and amortization ( 17,028 ) ( 14,293 ) Property and equipment, net $ 20,166 $ 22,160 |
Schedule of Accrued Liabilities | Accrued payroll and employee liabilities consist of the following (in thousands): December 31, 2023 2022 Accrued employee salaries and benefits $ 1,371 $ 2,134 Accrued bonuses 5,499 7,783 Accrued vacation 2,354 3,499 Total accrued payroll and employee liabilities $ 9,224 $ 13,416 Other accrued liabilities consist of the following (in thousands): December 31, 2023 2022 Accrued product sales allowances $ 36,529 $ 33,317 Accrued consulting and professional fees 3,940 4,236 Accrued accounts payable 559 363 Accrued interest 412 94 Other accrued liabilities 415 542 Total other accrued liabilities $ 41,855 $ 38,552 |
Revenue Recognition (Tables)
Revenue Recognition (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Revenue from Contract with Customer [Abstract] | |
Schedule of Disaggregated Net Product Sales | The following provides disaggregated net product sales (in thousands): For the Years Ended December 31, 2023 2022 CINVANTI net product sales $ 94,869 $ 87,245 SUSTOL net product sales 13,057 10,231 ZYNRELEF net product sales 17,727 10,196 APONVIE net product sales 1,391 — Total net product sales $ 127,044 $ 107,672 |
Summary of Activity to Product Returns, Distributor Fees and Discounts, Rebates, Administrative and Other Fees | The following provides a summary of activity with respect to our product returns, distributor fees and discounts, rebates, administrative and other fees, which are included in other accrued liabilities on the consolidated balance sheets (in thousands): Discounts, Rebates, Product Distributor Administrative and Returns Fees Other Fees Total Balance at December 31, 2022 $ 3,336 $ 4,180 $ 25,801 $ 33,317 Provision 2,638 23,722 169,651 196,011 Payments/credits ( 1,198 ) ( 23,483 ) ( 168,118 ) ( 192,799 ) Balance at December 31, 2023 $ 4,776 $ 4,419 $ 27,334 $ 36,529 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Summary of Future Minimum Lease Payments | Annual future minimum lease payments as of December 31, 2023 are as follows (in thousands): Year ended December 31: 2024 $ 3,153 2025 3,138 2026 — 2027 — 2028 — Thereafter — Total future minimum lease payments 6,291 Less: discount ( 416 ) Total lease liabilities $ 5,875 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Equity [Abstract] | |
Summary of Common Stock Reserved for Future Issuance | Shares of our common stock reserved for future issuance as of December 31, 2023 were as follows (in thousands): Number of Shares Stock options outstanding 24,575 Restricted stock units outstanding 1,405 Stock options available for grant 8,605 Shares of common stock reserved under the Employee Stock Purchase Plan 328 Shares of common stock underlying warrants 1,461 Shares of common stock underlying convertible notes outstanding (see Note 8) 9,819 Total shares reserved for future issuance 46,193 |
Equity Incentive Plans (Tables)
Equity Incentive Plans (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Equity [Abstract] | |
Summary of Stock Option Plan Activity | The following summarizes the stock option plan activity: Outstanding Options Weighted- Average Number of Exercise Shares Price Balance at December 31, 2022 20,749,349 $ 14.61 Granted 16,210,379 $ 1.69 Exercised ( 26,570 ) $ 1.32 Cancelled ( 12,358,296 ) $ 12.72 Balance at December 31, 2023 24,574,862 $ 7.06 Outstanding RSUs Weighted- Average Number of Grant Date Shares Fair Value Balance at December 31, 2022 3,167,397 $ 6.46 Granted 1,757,506 $ 2.39 Released ( 1,627,619 ) $ 6.34 Forfeited ( 1,892,355 ) $ 4.27 Balance at December 31, 2023 1,404,929 $ 4.43 |
Schedule of Options Exercisable, Vested or Expected to Vest | Years Ended December 31, 2023 2022 Weighted- Weighted- Average Average Exercise Exercise Options Price Options Price Exercisable at end of year 11,390,275 $ 12.87 13,650,210 $ 17.86 Options vested or expected to 24,574,862 $ 7.06 20,183,769 $ 14.82 |
Schedule of Exercise Prices and Weighted-average Remaining Contractual Lives for Options Outstanding | Exercise prices and weighted-average remaining contractual lives for the options outstanding as of December 31, 2023 were: Weighted- Weighted- Average Average Weighted- Exercise Remaining Average Price of Outstanding Range of Contractual Exercise Options Options Options Exercise Prices Life (in years) Price Exercisable Exercisable 6,179,628 $ 0.97 –$ 1.51 9.51 $ 1.25 344,006 $ 1.30 7,660,800 $ 1.52 –$ 2.28 9.28 1.77 2,001,281 1.78 3,406,724 $ 2.32 –$ 3.48 7.68 2.99 2,182,510 3.05 83,323 $ 3.61 –$ 5.42 8.61 4.08 34,239 4.09 21,459 $ 5.50 –$ 8.25 7.65 5.84 10,059 5.81 1,100,494 $ 8.80 –$ 13.20 3.57 11.18 996,018 11.20 3,116,010 $ 13.50 –$ 20.25 4.13 16.10 2,817,050 16.16 2,828,424 $ 20.93 –$ 31.40 4.26 25.72 2,827,112 25.72 178,000 $ 31.45 –$ 41.18 3.17 35.45 178,000 35.45 24,574,862 7.58 7.06 11,390,275 12.87 |
Summary of Stock-Based Compensation Expense related to Stock-Based Payment Awards | The following summarizes stock-based compensation expense related to stock-based payment awards pursuant to our equity compensation arrangements (in thousands): December 31, 2023 2022 Research and development $ 10,880 $ 17,909 General and administrative 12,471 11,688 Sales and marketing 9,503 13,383 Total stock-based compensation expense $ 32,854 $ 42,980 |
Summary of Fair Value of Option Grant and ESPP Purchase Right on Grant Date Using Black-Scholes Option Pricing Model | We estimated the fair value of each option grant and ESPP purchase right on the date of grant using the Black-Scholes option pricing model with the following weighted-average assumptions: Options: December 31, 2023 2022 Risk-free interest rate 3.7 % 3.3 % Dividend yield — % — % Volatility 68.1 % 62.0 % Expected life (years) 6 to 10 6 ESPP: December 31, 2023 2022 Risk-free interest rate 5.3 % 3.2 % Dividend yield — % — % Volatility 99.6 % 83.8 % Expected life (months) 6 6 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Schedule of Components of Income Tax Expense (Benefit) | The difference between the provision for income taxes and income taxes computed using the effective U.S. federal statutory rate is as follows (in thousands): December 31, 2023 2022 Tax at statutory federal rate $ ( 23,210 ) $ ( 38,225 ) State tax, net of federal benefit ( 1,460 ) ( 13,898 ) Research and development credits — ( 3,531 ) Stock-based compensation expense 19,022 5,857 Non-deductible compensation ( 4,682 ) 2,104 Employee retention credit adjustment — ( 1,265 ) Change in valuation allowance 7,556 46,452 Provision to return adjustment 3,008 — Other ( 234 ) 2,506 Provision for income taxes $ — $ — |
Schedule of Deferred Tax Assets and Liabilities | Deferred income tax assets and liabilities arising from differences between accounting for financial statement purposes and tax purposes, less valuation allowance at year-end are as follows (in thousands): December 31, 2023 2022 Deferred tax assets: Net operating loss carryforward $ 320,998 $ 313,834 Research and development credits 59,417 60,245 Section 174 capitalized research and development 28,822 20,903 Stock-based compensation 15,413 23,991 Lease liabilities 1,471 2,052 Other 5,005 3,693 Total gross deferred tax assets 431,126 424,718 Deferred tax liabilities: Right-of-use lease assets ( 1,362 ) ( 1,914 ) Total gross deferred tax liabilities ( 1,362 ) ( 1,914 ) Valuation allowance ( 429,764 ) ( 422,804 ) Net deferred tax assets $ — $ — |
Summary of Unrecognized Tax Benefits | A reconciliation of our unrecognized tax benefits is as follows (in thousands): Year Ended December 31, 2023 2022 Balance at beginning of year $ 11,235 $ 9,631 Decrease for tax positions of prior years ( 332 ) ( 200 ) Increase based on tax positions related to current year — 1,804 Balance at end of year $ 10,903 $ 11,235 |
Organization and Business - Add
Organization and Business - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Business [Line Items] | ||
Accumulated deficit | $ (1,906,014) | $ (1,795,455) |
Cash, cash equivalents and short-term investments | 80,400 | |
Net loss | $ (110,559) | $ (182,024) |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies - Percentage of Net Product Sales and Accounts Receivable Balance (Details) - Customer Concentration Risk | 12 Months Ended |
Dec. 31, 2023 | |
Revenue Benchmark | Largest Customer | |
Product Information [Line Items] | |
Concentration risk percentage | 43.30% |
Revenue Benchmark | Second Largest Customer | |
Product Information [Line Items] | |
Concentration risk percentage | 36.80% |
Revenue Benchmark | Third Largest Customer | |
Product Information [Line Items] | |
Concentration risk percentage | 19% |
Revenue Benchmark | Total Customer | |
Product Information [Line Items] | |
Concentration risk percentage | 99.10% |
Accounts Receivable | Largest Customer | |
Product Information [Line Items] | |
Concentration risk percentage | 42.10% |
Accounts Receivable | Second Largest Customer | |
Product Information [Line Items] | |
Concentration risk percentage | 36.10% |
Accounts Receivable | Third Largest Customer | |
Product Information [Line Items] | |
Concentration risk percentage | 21.50% |
Accounts Receivable | Total Customer | |
Product Information [Line Items] | |
Concentration risk percentage | 99.70% |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Details) | 12 Months Ended |
Dec. 31, 2023 Segment | |
Product Information [Line Items] | |
Property, Plant, and Equipment, Useful Life, Term, Description [Extensible Enumeration] | us-gaap:UsefulLifeTermOfLeaseMember |
Number of Operating Segments | 1 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Common Stock Equivalents Excluded From Computation of Net Loss Per Share (Details) - shares shares in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share-based Payment Arrangement, Option | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Shares excluded (in shares) | 24,575 | 20,749 |
Restricted Stock Units | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Shares excluded (in shares) | 1,405 | 3,167 |
Warrant | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Shares excluded (in shares) | 298 | 8,548 |
Convertible Debt Securities | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Shares excluded (in shares) | 9,819 | 9,819 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Financial Assets Measured on a Recurring Basis (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | $ 51,732 | $ 69,488 |
U.S. Treasury Bills and Government Agency Obligations | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 31,636 | 35,715 |
U.S. Corporate Debt | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 11,653 | |
Foreign Corporate Debt | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 5,460 | |
U.S. Commercial Paper | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 1,990 | 5,481 |
Fair Value, Recurring | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total | 80,409 | 84,852 |
Fair Value, Recurring | Foreign Commercial Paper | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 993 | 28,292 |
Fair Value, Recurring | U.S. Treasury Bills and Government Agency Obligations | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 31,636 | 35,715 |
Fair Value, Recurring | U.S. Corporate Debt | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 16,889 | 1,497 |
Fair Value, Recurring | Foreign Corporate Debt | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 5,460 | |
Fair Value, Recurring | U.S. Commercial Paper | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 1,990 | 5,481 |
Fair Value, Recurring | Cash and Money Market Funds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash and money market funds | 23,441 | 13,867 |
Fair Value, Recurring | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total | 55,077 | 49,582 |
Fair Value, Recurring | Quoted Prices in Active Markets for Identical Assets (Level 1) | U.S. Treasury Bills and Government Agency Obligations | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 31,636 | 35,715 |
Fair Value, Recurring | Quoted Prices in Active Markets for Identical Assets (Level 1) | Cash and Money Market Funds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash and money market funds | 23,441 | 13,867 |
Fair Value, Recurring | Significant Other Observable Inputs (Level 2) | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total | 25,332 | 35,270 |
Fair Value, Recurring | Significant Other Observable Inputs (Level 2) | Foreign Commercial Paper | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 993 | 28,292 |
Fair Value, Recurring | Significant Other Observable Inputs (Level 2) | U.S. Corporate Debt | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 16,889 | 1,497 |
Fair Value, Recurring | Significant Other Observable Inputs (Level 2) | Foreign Corporate Debt | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 5,460 | |
Fair Value, Recurring | Significant Other Observable Inputs (Level 2) | U.S. Commercial Paper | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | $ 1,990 | $ 5,481 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Fair Value Disclosures [Abstract] | ||
Financial instruments transferred among fair value hierarchy levels | $ 0 | |
Cash equivalents included of available-for-sale securities | 5,300,000 | $ 1,500,000 |
Available for sale securities with contractual maturities of three months to one year. | $ 51,700,000 | $ 69,500,000 |
Balance Sheet Details - Summary
Balance Sheet Details - Summary of Short -Term Investments (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Schedule Of Available For Sale Securities [Line Items] | ||
Available-for-sale securities, amortized cost | $ 51,720 | $ 69,507 |
Available-for-sale securities, gross unrealized gains | 13 | |
Available-for-sale securities, gross unrealized losses | (1) | (19) |
Available-for-sale securities | 51,732 | 69,488 |
U.S. Treasury Bills and Government Agency Obligations | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Available-for-sale securities, amortized cost | 31,625 | 35,734 |
Available-for-sale securities, gross unrealized gains | 11 | |
Available-for-sale securities, gross unrealized losses | (19) | |
Available-for-sale securities | 31,636 | 35,715 |
U.S. Corporate Debt | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Available-for-sale securities, amortized cost | 11,652 | |
Available-for-sale securities, gross unrealized gains | 1 | |
Available-for-sale securities | 11,653 | |
Foreign Corporate Debt | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Available-for-sale securities, amortized cost | 5,459 | |
Available-for-sale securities, gross unrealized gains | 1 | |
Available-for-sale securities | 5,460 | |
U.S. Commercial Paper | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Available-for-sale securities, amortized cost | 1,991 | 5,481 |
Available-for-sale securities, gross unrealized losses | (1) | |
Available-for-sale securities | 1,990 | 5,481 |
Foreign Commercial Paper | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Available-for-sale securities, amortized cost | 993 | 28,292 |
Available-for-sale securities | $ 993 | $ 28,292 |
Balance Sheet Details - Additio
Balance Sheet Details - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Debt securities, impairment losses | $ 0 | $ 0 |
Debt securities, available-for-sale, unrealized gain (loss) | 32,000 | (13,000) |
Debt securities, available-for-sale, realized gain (loss) | 1,000 | 0 |
Total inventory | 42,110,000 | 54,573,000 |
Depreciation and amortization | 2,899,000 | 2,889,000 |
Construction in Progress, Gross | 6,300,000 | 5,400,000 |
ZYNRELEF | ||
Total inventory | 11,200,000 | 30,900,000 |
Cost of product sales, charges | 20,300,000 | 8,900,000 |
SUSTOL | ||
Total inventory | 4,100,000 | 2,600,000 |
CINVANTI | ||
Total inventory | 26,400,000 | 19,900,000 |
APONVIE | ||
Total inventory | $ 400,000 | $ 1,200,000 |
Balance Sheet Details - Schedul
Balance Sheet Details - Schedule of Inventory (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 17,643 | $ 15,137 |
Work in process | 14,550 | 20,723 |
Finished goods | 9,917 | 18,713 |
Total inventory | $ 42,110 | $ 54,573 |
Balance Sheet Details - Sched_2
Balance Sheet Details - Schedule of Prepaid Expenses and Other Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Prepaid Expense and Other Assets, Current [Abstract] | ||
Prepaid expenses | $ 11,731 | $ 21,120 |
Prepaid insurance | 1,910 | 1,947 |
Interest receivable | 310 | 154 |
Deposits | 274 | 254 |
Other receivables | 21 | 6,197 |
Total prepaid expenses and other assets | $ 14,246 | $ 29,672 |
Balance Sheet Details - Sched_3
Balance Sheet Details - Schedule of Property and Equipment, Net (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 37,194 | $ 36,453 |
Less: accumulated depreciation and amortization | (17,028) | (14,293) |
Property and equipment, net | 20,166 | 22,160 |
Scientific Equipment | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 34,027 | 33,318 |
Leasehold Improvements | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 647 | 647 |
Computer Equipment and Software | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 1,506 | 1,506 |
Furniture, Fixtures and Office Equipment | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 1,014 | $ 982 |
Balance Sheet Details - Sched_4
Balance Sheet Details - Schedule of Accrued Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Accrued payroll and employee liabilities | ||
Accrued employee salaries and benefits | $ 1,371 | $ 2,134 |
Accrued bonuses | 5,499 | 7,783 |
Accrued vacation | 2,354 | 3,499 |
Total accrued payroll and employee liabilities | 9,224 | 13,416 |
Other accrued liabilities | ||
Accrued product sales allowances | 36,529 | 33,317 |
Accrued consulting and professional fees | 3,940 | 4,236 |
Accrued accounts payable | 559 | 363 |
Accrued interest | 412 | 94 |
Other accrued liabilities | 415 | 542 |
Total other accrued liabilities | $ 41,855 | $ 38,552 |
Revenue Recognition - Schedule
Revenue Recognition - Schedule of Disaggregated Net Product Sales (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Product Information [Line Items] | ||
Net product sales | $ 127,044 | $ 107,672 |
CINVANTI | ||
Product Information [Line Items] | ||
Net product sales | 94,869 | 87,245 |
SUSTOL | ||
Product Information [Line Items] | ||
Net product sales | 13,057 | 10,231 |
ZYNRELEF | ||
Product Information [Line Items] | ||
Net product sales | 17,727 | $ 10,196 |
APONVIE | ||
Product Information [Line Items] | ||
Net product sales | $ 1,391 |
Revenue Recognition - Summary o
Revenue Recognition - Summary of Activity to Product Returns, Distributor Fees and Discounts, Rebates, Administrative and Other Fees (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2023 USD ($) | |
Product Information [Line Items] | |
Balance | $ 33,317 |
Provision | 196,011 |
Payments/credits | (192,799) |
Balance | 36,529 |
Product Returns | |
Product Information [Line Items] | |
Balance | 3,336 |
Provision | 2,638 |
Payments/credits | (1,198) |
Balance | 4,776 |
Distributor Fees | |
Product Information [Line Items] | |
Balance | 4,180 |
Provision | 23,722 |
Payments/credits | (23,483) |
Balance | 4,419 |
Discounts, Rebates, Administrative and Other Fees | |
Product Information [Line Items] | |
Balance | 25,801 |
Provision | 169,651 |
Payments/credits | (168,118) |
Balance | $ 27,334 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) $ in Millions | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2023 ft² | Dec. 31, 2023 USD ($) ft² | Dec. 31, 2022 USD ($) | Oct. 31, 2021 ft² | |
Lessee Lease Description [Line Items] | ||||
Operating lease cash payments | $ 3 | $ 2.9 | ||
Purchase obligations due in one year | 39 | |||
Purchase obligations due in two to three year | 21.2 | |||
Operating lease, rent expense | 2.9 | $ 2.8 | ||
Total purchase obligations | $ 60.2 | |||
Maximum | ||||
Lessee Lease Description [Line Items] | ||||
Purchase obligations due period | 3 years | |||
Minimum | ||||
Lessee Lease Description [Line Items] | ||||
Purchase obligations due period | 2 years | |||
Sublease Agreement | ||||
Lessee Lease Description [Line Items] | ||||
Area of real estate property | ft² | 23,873 | |||
San Diego, California | ||||
Lessee Lease Description [Line Items] | ||||
Area of real estate property | ft² | 52,148 | |||
Lease expiration date | Dec. 31, 2025 | |||
Lessee, operating lease, renewal term | 5 years | |||
Remaining area of real estate property | ft² | 28,275 | 28,275 | ||
Lessee, operating lease, existence of option to extend | true | |||
Cary, North Carolina | Sublease Agreement | ||||
Lessee Lease Description [Line Items] | ||||
Area of real estate property | ft² | 5,840 | |||
Lease expiration date | Apr. 30, 2025 |
Commitments and Contingencies_2
Commitments and Contingencies - Summary of Future Minimum Lease Payments (Details) $ in Thousands | Dec. 31, 2023 USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2024 | $ 3,153 |
2025 | 3,138 |
Total future minimum lease payments | 6,291 |
Less: discount | (416) |
Total lease liabilities | $ 5,875 |
Reorganization - Additional Inf
Reorganization - Additional Information (Details) $ in Millions | 1 Months Ended | 12 Months Ended | ||
Jun. 30, 2023 USD ($) | Jun. 30, 2022 USD ($) | Dec. 31, 2023 USD ($) Officers | Dec. 31, 2022 USD ($) | |
Restructuring charges, total | $ 5.4 | |||
Number of executive officers terminated | Officers | 5 | |||
Anticipated restructuring expense | $ 13.4 | |||
2023 Restructuring Plan | ||||
Payments for restructuring charges | 4.2 | |||
2023 Restructuring Plan | Research and Development Expense | ||||
Restructuring charges, total | 1.7 | |||
2023 Restructuring Plan | General and Administrative Expense | ||||
Restructuring charges, total | 0.1 | |||
2023 Restructuring Plan | Sales and Marketing Expense | ||||
Restructuring charges, total | 2.4 | |||
2022 Restructuring Plan | ||||
Payments for restructuring charges | $ 5.4 | |||
2022 Restructuring Plan | Research and Development Expense | ||||
Restructuring charges, total | 4.2 | |||
2022 Restructuring Plan | General and Administrative Expense | ||||
Restructuring charges, total | 0.2 | |||
2022 Restructuring Plan | Sales and Marketing Expense | ||||
Restructuring charges, total | $ 1 | |||
Executive Officer Departures | ||||
Restructuring charges, total | 13.4 | |||
Executive Officer Departures | Research and Development Expense | ||||
Restructuring charges, total | 2.3 | |||
Executive Officer Departures | General and Administrative Expense | ||||
Restructuring charges, total | 7.2 | |||
Executive Officer Departures | Sales and Marketing Expense | ||||
Restructuring charges, total | 3.9 | |||
Employee Severance | ||||
Restructuring charges, total | 5 | |||
Anticipated restructuring expense | 4.7 | |||
Employee Severance | 2023 Restructuring Plan | ||||
Restructuring charges, total | $ 4.2 | |||
Payments for restructuring charges | 3.7 | |||
Accelerated Non-Cash Stock Option Expense | ||||
Restructuring charges, total | $ 0.4 | |||
Non-Cash, Stock-based Compensation Expense | ||||
Anticipated restructuring expense | $ 8.7 |
Convertible Notes - Additional
Convertible Notes - Additional Information (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |||
Aug. 15, 2023 | Aug. 09, 2023 | May 31, 2021 | Dec. 31, 2023 | Dec. 31, 2022 | |
Debt Instrument [Line Items] | |||||
Amortization of debt issuance costs | $ 206,000 | $ 202,000 | |||
Debt instrument convertible type of equity security | The Loan Agreement has a term of four years, with a springing maturity date that is 91 days prior to the stated maturity of our existing senior unsecured convertible notes (if still outstanding at such time). | ||||
Loan agreement, term | 4 years | ||||
Loan agreement spring maturity date | 91 days | ||||
Debt instrument, interest rate | 9.95% | ||||
Accrued paid-in-kind interest | $ 1.5 | ||||
Amortization of debt discount | 133,000 | ||||
Common Stock | |||||
Debt Instrument [Line Items] | |||||
Initial conversion price/rate | $ 15.276 | ||||
Warrant | |||||
Debt Instrument [Line Items] | |||||
Percentage of principal amount of loan funded to lender | 2% | ||||
Hercules Capital Inc | |||||
Debt Instrument [Line Items] | |||||
Convertible debt issuable in connection with private placement | 50,000,000 | ||||
Debt issuance costs incurred | $ 600,000 | ||||
Effective interest rate | 14.50% | ||||
Interest expense | 1,300,000 | ||||
Interest expense, debt, excluding amortization | 1,000,000 | ||||
Paid-in-kind interest amount | 200,000 | ||||
Amortization of debt discount | $ 800,000 | 100,000 | |||
Number of shares warrant issued to lender | 297,619 | ||||
Common stock exercise price, per share | $ 1.68 | ||||
Minimum cash covenant amount, requiring to hold cash | $ 8,500,000 | ||||
Maximum amount of market capitalization | 400,000,000 | ||||
Warrants related fair value recongnized amount | 400,000 | ||||
Debt instrument, face amount | $ 25,000,000 | ||||
Hercules Capital Inc | Common Stock | |||||
Debt Instrument [Line Items] | |||||
Number of shares warrant issued to lender | 297,619 | ||||
Hercules Capital Inc | Maximum | Common Stock | |||||
Debt Instrument [Line Items] | |||||
Number of shares warrant issued to lender | 297,619 | ||||
Hercules Capital Inc | Tranche 1A | |||||
Debt Instrument [Line Items] | |||||
Convertible debt issuable in connection with private placement | 25,000,000 | ||||
Carrying value of debt | 24,300,000 | ||||
Debt instrument, face amount | $ 25,000,000 | 25,200,000 | |||
Debt issuance costs | 900,000 | ||||
Hercules Capital Inc | Tranche 1B | |||||
Debt Instrument [Line Items] | |||||
Convertible debt issuable in connection with private placement | 5,000,000 | ||||
Hercules Capital Inc | Tranche 1C | |||||
Debt Instrument [Line Items] | |||||
Convertible debt issuable in connection with private placement | $ 20,000,000 | ||||
Notes | |||||
Debt Instrument [Line Items] | |||||
Amortization of debt issuance costs | 200,000 | ||||
Debt instrument, interest rate | 1.50% | ||||
Convertible debt issuable in connection with private placement | $ 150,000,000 | ||||
Debt issuance costs incurred | $ 1,000,000 | ||||
Effective interest rate | 1.60% | ||||
Interest expense | $ 2,500,000 | ||||
Interest expense, debt, excluding amortization | 2,300,000 | ||||
Net proceeds from convertible notes financing | $ 149,000,000 | ||||
Debt instrument, maturity date | May 26, 2026 | ||||
Debt instrument, frequency of periodic payment | semi-annually | ||||
Debt instrument, date of first required payment | Dec. 15, 2021 | ||||
Initial conversion price/rate | $ 65.4620 | ||||
Debt instrument conversion ratio multiple of principal | $ 1,000 | ||||
Common shares registered for resale in connection with convertible notes | 12,400,000 | ||||
Carrying value of debt | 149,500,000 | ||||
Debt instrument, face amount | 150,000,000 | ||||
Debt issuance costs | $ 500,000 | ||||
Notes | Redemption Between May 24, 2024 and May 24, 2025 | |||||
Debt Instrument [Line Items] | |||||
Debt instrument, redemption period, stock price exceeds in percentage of conversion price | 250% | ||||
Notes | Redemption On or After May 24, 2025 | |||||
Debt Instrument [Line Items] | |||||
Debt instrument, redemption period, stock price exceeds in percentage of conversion price | 200% |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 12 Months Ended | |||||
Aug. 31, 2023 | Jul. 21, 2023 | Oct. 18, 2022 | Aug. 08, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | |
Class Of Stock [Line Items] | ||||||
Common shares registered for resale | 21,900 | 24,600 | ||||
Proceeds from issuance of common stock | $ 29,755 | $ 75,145 | ||||
Private Placement | ||||||
Class Of Stock [Line Items] | ||||||
Shares of common stock sold | 16,100 | |||||
Purchase price per share | $ 3.10 | |||||
Proceeds from issuance of common stock and pre-funded warrants | $ 75,100 | |||||
Stock issuance cost | $ 1,400 | |||||
Pre-funded Warrants | ||||||
Class Of Stock [Line Items] | ||||||
Purchase price per share | $ 1.3699 | $ 3.0999 | ||||
Class of warrant or right, number of securities called by warrants or rights | 1,200 | 8,500 | ||||
Class of warrant or right, exercise price of warrants or rights | $ 0.0001 | $ 0.0001 | ||||
2023 Private Placement | ||||||
Class Of Stock [Line Items] | ||||||
Shares of common stock sold | 20,700 | |||||
Purchase price per share | $ 1.37 | |||||
Proceeds from issuance of common stock and pre-funded warrants | $ 29,800 | |||||
Stock issuance cost | $ 200 | |||||
Common Stock | Private Placement | ||||||
Class Of Stock [Line Items] | ||||||
Shares of common stock sold | 20,735 | 16,129 |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Common Stock Reserved for Future Issuance (Details) - shares | Dec. 31, 2023 | Dec. 31, 2022 |
Stockholders' Equity Note [Abstract] | ||
Stock options outstanding | 24,574,862 | 20,749,349 |
Restricted stock units outstanding | 1,405,000 | |
Stock options available for grant | 8,605,000 | |
Shares of common stock underlying warrants | 1,461,000 | |
Shares of common stock underlying convertible notes outstanding (see Note 8) | 9,819,000 | |
Total shares reserved for future issuance | 46,193,000 |
Equity Incentive Plan - Additio
Equity Incentive Plan - Additional Information (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |||||||||||||
Jun. 30, 2023 | May 31, 2022 | Jun. 30, 2021 | Jun. 30, 2019 | Jun. 30, 2017 | Jun. 30, 2016 | May 31, 2015 | May 31, 2014 | Jun. 30, 2011 | May 31, 2010 | May 31, 2009 | Dec. 31, 2007 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 1997 | |
Class Of Stock [Line Items] | |||||||||||||||
Share-based compensation arrangements by share-based payment award, options, exercises in period, weighted average exercise price | $ 1.32 | ||||||||||||||
Common stock, shares, issued, total | 150,285,044 | 119,154,538 | |||||||||||||
Common stock, capital shares reserved for future issuance | 46,193,000 | ||||||||||||||
Share-based compensation arrangement by share-based payment award, number of shares available for grant | 8,605,000 | ||||||||||||||
Share-based compensation arrangement by share-based payment award, expiration period | 10 years | ||||||||||||||
Share-based compensation arrangement by share-based payment award, award vesting period | 4 years | ||||||||||||||
Share-based compensation arrangement by share-based payment award, options, exercisable, weighted average remaining contractual term | 5 years 7 months 6 days | ||||||||||||||
Share-based compensation arrangement by share-based payment award, options, exercises in period | 26,570 | 0 | |||||||||||||
Share-based compensation arrangement by share-based payment award, options, exercises in period, intrinsic value | $ 10,000 | ||||||||||||||
Share-based compensation arrangement by share-based payment award, options, outstanding, intrinsic value | $ 137,000 | $ 0 | |||||||||||||
Common stock future issuance on exercise of outstanding options and vesting of outstanding restricted stock units granted | 25,979,791 | ||||||||||||||
Total unrecognized compensation cost related to non-vested, stock-based payment awards | $ 23,200,000 | ||||||||||||||
Total unrecognized compensation cost, expect to recognize over weighted average period | 3 years | ||||||||||||||
Restricted Stock Units | |||||||||||||||
Class Of Stock [Line Items] | |||||||||||||||
Share-based compensation arrangement by share-based payment award, award vesting period | 4 years | ||||||||||||||
Share-based Payment Arrangement, Option | |||||||||||||||
Class Of Stock [Line Items] | |||||||||||||||
Share-based compensation arrangement by share-based payment award, options, forfeitures in period | 11,508,070 | ||||||||||||||
Share-based compensation arrangements by share-based payment award, options, forfeitures in period, weighted average exercise price | $ 13.1 | ||||||||||||||
Share-based compensation arrangement by share-based payment award, options, expirations in period | 850,226 | ||||||||||||||
Share-based compensation arrangements by share-based payment award, options, expirations in period, weighted average exercise price | $ 7.47 | ||||||||||||||
Expected life | 6 years | ||||||||||||||
Employee Stock Purchase Plan | |||||||||||||||
Class Of Stock [Line Items] | |||||||||||||||
Share-based compensation arrangement by share-based payment award, number of shares authorized | 10,000 | ||||||||||||||
Share-based compensation arrangement by share-based payment award, number of additional shares authorized | 400,000 | 850,000 | 200,000 | 300,000 | 200,000 | 100,000 | 100,000 | 25,000 | 25,000 | 10,000 | 5,000 | 2,225,000 | |||
Share-based compensation arrangement by share-based payment award maximum employee earnings with held to purchase common stock percent | 10% | ||||||||||||||
Share-based compensation arrangement by share-based payment award discount on stock price | 85% | ||||||||||||||
Share-based compensation arrangement by share-based payment award, shares issued in period | 717,046 | 406,421 | |||||||||||||
Share-based compensation arrangements by share-based payment award, options, exercises in period, weighted average exercise price | $ 1.26 | $ 3.55 | |||||||||||||
Common stock, shares, issued, total | 1,897,445 | ||||||||||||||
Common stock, capital shares reserved for future issuance | 327,555 | ||||||||||||||
Share-based compensation arrangement by share-based payment award, options, grants in period, weighted average grant date fair value | $ 1.13 | 1.71 | |||||||||||||
Share-based compensation arrangement by share-based payment award, per share weighted-average fair value price of shares purchased | $ 0.64 | $ 1.65 | |||||||||||||
Expected life | 6 months | ||||||||||||||
Equity Incentive Plan 2007 | |||||||||||||||
Class Of Stock [Line Items] | |||||||||||||||
Share-based compensation arrangement by share-based payment award, number of shares authorized | 150,000 | ||||||||||||||
Share-based compensation arrangement by share-based payment award, number of additional shares authorized | 8,490,000 | 2,900,000 | 2,000,000 | 7,000,000 | 5,000,000 | 3,000,000 | 4,300,000 | 1,750,000 | 4,500,000 | 100,000 | 39,190,000 | ||||
Share-based compensation arrangement by share-based payment award, number of shares available for grant | 8,605,026 |
Equity Incentive Plans - Summar
Equity Incentive Plans - Summary of Stock Option Plan Activity (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Number of shares outstanding | 20,749,349 | |
Number of shares granted | 16,210,379 | |
Number of shares exercised | (26,570) | 0 |
Number of shares cancelled | (12,358,296) | |
Number of shares outstanding | 24,574,862 | 20,749,349 |
Number of shares outstanding, weighted average exercise price | $ 14.61 | |
Number of shares granted, weighted average exercise price | 1.69 | |
Number of shares exercised, weighted average exercise price | 1.32 | |
Number of shares cancelled, weighted average exercise price | 12.72 | |
Number of shares outstanding, weighted average exercise price | $ 7.06 | $ 14.61 |
Restricted Stock Units | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Number of shares outstanding | 3,167,397 | |
Number of shares granted | 1,757,506 | |
Number of shares released | (1,627,619) | |
Number of shares forfeited | (1,892,355) | |
Number of shares outstanding | 1,404,929 | 3,167,397 |
Number of shares outstanding, weighted average grant date fair value | $ 6.46 | |
Number of shares granted, weighted average grant date fair value | 2.39 | |
Number of shares released, weighted average grant date fair value | 6.34 | |
Number of shares forfeited, weighted average grant date fair value | 4.27 | |
Number of shares outstanding, weighted average grant date fair value | $ 4.43 | $ 6.46 |
Equity Incentive Plan - Schedul
Equity Incentive Plan - Schedule of Options Exercisable, Vested or Expected to Vest (Details) - $ / shares | Dec. 31, 2023 | Dec. 31, 2022 |
Equity [Abstract] | ||
Options exercisable at end of year | 11,390,275 | 13,650,210 |
Options vested or expected to vest | 24,574,862 | 20,183,769 |
Options exercisable at end of year, weighted average exercise price | $ 12.87 | $ 17.86 |
Options vested or expected to vest, weighted average exercise price | $ 7.06 | $ 14.82 |
Equity Incentive Plan - Sched_2
Equity Incentive Plan - Schedule of Exercise Prices and Weighted-average Remaining Contractual Lives for Options Outstanding (Details) | 12 Months Ended |
Dec. 31, 2023 $ / shares shares | |
Options Outstanding (in shares) | shares | 24,574,862 |
Weighted- Average Remaining Contractual Life (Year) | 7 years 6 months 29 days |
Weighted- Average Exercise Price (in dollars per share) | $ 7.06 |
Options Exercisable (in shares) | shares | 11,390,275 |
Weighted- Average Exercise Price of Options Exercisable | $ 12.87 |
Exercise Price Range 1 | |
Options Outstanding (in shares) | shares | 6,179,628 |
Range of Exercise Prices, Lower Limit (in dollars per share) | $ 0.97 |
Range of Exercise Prices, Upper Limit (in dollars per share) | $ 1.51 |
Weighted- Average Remaining Contractual Life (Year) | 9 years 6 months 3 days |
Weighted- Average Exercise Price (in dollars per share) | $ 1.25 |
Options Exercisable (in shares) | shares | 344,006 |
Weighted- Average Exercise Price of Options Exercisable | $ 1.3 |
Exercise Price Range 2 | |
Options Outstanding (in shares) | shares | 7,660,800 |
Range of Exercise Prices, Lower Limit (in dollars per share) | $ 1.52 |
Range of Exercise Prices, Upper Limit (in dollars per share) | $ 2.28 |
Weighted- Average Remaining Contractual Life (Year) | 9 years 3 months 10 days |
Weighted- Average Exercise Price (in dollars per share) | $ 1.77 |
Options Exercisable (in shares) | shares | 2,001,281 |
Weighted- Average Exercise Price of Options Exercisable | $ 1.78 |
Exercise Price Range 3 | |
Options Outstanding (in shares) | shares | 3,406,724 |
Range of Exercise Prices, Lower Limit (in dollars per share) | $ 2.32 |
Range of Exercise Prices, Upper Limit (in dollars per share) | $ 3.48 |
Weighted- Average Remaining Contractual Life (Year) | 7 years 8 months 4 days |
Weighted- Average Exercise Price (in dollars per share) | $ 2.99 |
Options Exercisable (in shares) | shares | 2,182,510 |
Weighted- Average Exercise Price of Options Exercisable | $ 3.05 |
Exercise Price Range 4 | |
Options Outstanding (in shares) | shares | 83,323 |
Range of Exercise Prices, Lower Limit (in dollars per share) | $ 3.61 |
Range of Exercise Prices, Upper Limit (in dollars per share) | $ 5.42 |
Weighted- Average Remaining Contractual Life (Year) | 8 years 7 months 9 days |
Weighted- Average Exercise Price (in dollars per share) | $ 4.08 |
Options Exercisable (in shares) | shares | 34,239 |
Weighted- Average Exercise Price of Options Exercisable | $ 4.09 |
Exercise Price Range 5 | |
Options Outstanding (in shares) | shares | 21,459 |
Range of Exercise Prices, Lower Limit (in dollars per share) | $ 5.5 |
Range of Exercise Prices, Upper Limit (in dollars per share) | $ 8.25 |
Weighted- Average Remaining Contractual Life (Year) | 7 years 7 months 24 days |
Weighted- Average Exercise Price (in dollars per share) | $ 5.84 |
Options Exercisable (in shares) | shares | 10,059 |
Weighted- Average Exercise Price of Options Exercisable | $ 5.81 |
Exercise Price Range 6 | |
Options Outstanding (in shares) | shares | 1,100,494 |
Range of Exercise Prices, Lower Limit (in dollars per share) | $ 8.8 |
Range of Exercise Prices, Upper Limit (in dollars per share) | $ 13.2 |
Weighted- Average Remaining Contractual Life (Year) | 3 years 6 months 25 days |
Weighted- Average Exercise Price (in dollars per share) | $ 11.18 |
Options Exercisable (in shares) | shares | 996,018 |
Weighted- Average Exercise Price of Options Exercisable | $ 11.2 |
Exercise Price Range 7 | |
Options Outstanding (in shares) | shares | 3,116,010 |
Range of Exercise Prices, Lower Limit (in dollars per share) | $ 13.5 |
Range of Exercise Prices, Upper Limit (in dollars per share) | $ 20.25 |
Weighted- Average Remaining Contractual Life (Year) | 4 years 1 month 17 days |
Weighted- Average Exercise Price (in dollars per share) | $ 16.1 |
Options Exercisable (in shares) | shares | 2,817,050 |
Weighted- Average Exercise Price of Options Exercisable | $ 16.16 |
Exercise Price Range 8 | |
Options Outstanding (in shares) | shares | 2,828,424 |
Range of Exercise Prices, Lower Limit (in dollars per share) | $ 20.93 |
Range of Exercise Prices, Upper Limit (in dollars per share) | $ 31.4 |
Weighted- Average Remaining Contractual Life (Year) | 4 years 3 months 3 days |
Weighted- Average Exercise Price (in dollars per share) | $ 25.72 |
Options Exercisable (in shares) | shares | 2,827,112 |
Weighted- Average Exercise Price of Options Exercisable | $ 25.72 |
Exercise Price Range 9 | |
Options Outstanding (in shares) | shares | 178,000 |
Range of Exercise Prices, Lower Limit (in dollars per share) | $ 31.45 |
Range of Exercise Prices, Upper Limit (in dollars per share) | $ 41.18 |
Weighted- Average Remaining Contractual Life (Year) | 3 years 2 months 1 day |
Weighted- Average Exercise Price (in dollars per share) | $ 35.45 |
Options Exercisable (in shares) | shares | 178,000 |
Weighted- Average Exercise Price of Options Exercisable | $ 35.45 |
Equity Incentive Plan - Summary
Equity Incentive Plan - Summary of Stock-Based Compensation Expense related to Stock-Based Payment Awards (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Stock-based compensation expense | $ 32,854 | $ 42,980 |
Research and Development Expense | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Stock-based compensation expense | 10,880 | 17,909 |
General and Administrative Expense | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Stock-based compensation expense | 12,471 | 11,688 |
Sales and Marketing Expense | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Stock-based compensation expense | $ 9,503 | $ 13,383 |
Equity Incentive Plan - Summa_2
Equity Incentive Plan - Summary of Fair Value of Option Grant and ESPP Purchase Right on Grant Date Using Black-Scholes Option Pricing Model (Details) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share-based Payment Arrangement, Option | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Risk-free interest rate | 3.70% | 3.30% |
Dividend yield | 0% | 0% |
Volatility | 68.10% | 62% |
Expected life | 6 years | |
Share-based Payment Arrangement, Option | Minimum | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected life | 6 years | |
Share-based Payment Arrangement, Option | Maximum | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected life | 10 years | |
Employee Stock Purchase Plan | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Risk-free interest rate | 5.30% | 3.20% |
Dividend yield | 0% | 0% |
Volatility | 99.60% | 83.80% |
Expected life | 6 months | 6 months |
Employee Benefit Plan - Additio
Employee Benefit Plan - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Defined Benefit Plan Disclosure [Line Items] | ||
Defined contribution plan, employer matching contribution, percent of match | 50% | |
Defined contribution plan, maximum annual contributions by employer per employee, amount | $ 9,900 | $ 9,150 |
Defined contribution plan, cost | $ 1,000,000 | $ 1,400,000 |
Maximum | ||
Defined Benefit Plan Disclosure [Line Items] | ||
Defined contribution plan, employer matching contribution, percent of employees' gross pay | 3% |
Income Taxes - Schedule of Comp
Income Taxes - Schedule of Components of Income Tax Expense (Benefit) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | ||
Tax at statutory federal rate | $ (23,210) | $ (38,225) |
State tax, net of federal benefit | (1,460) | (13,898) |
Research and development credits | 0 | (3,531) |
Stock-based compensation expense | 19,022 | 5,857 |
Non-deductible compensation | (4,682) | 2,104 |
Employee retention credit adjustment | 0 | (1,265) |
Change in valuation allowance | 7,556 | 46,452 |
Provision to return adjustment | 3,008 | 0 |
Other | 234 | 2,506 |
Provision for income taxes | $ 0 | $ 0 |
Income Taxes - Schedule of Defe
Income Taxes - Schedule of Deferred Tax Assets and Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Deferred tax assets: | ||
Net operating loss carryforward | $ 320,998 | $ 313,834 |
Research and development credits | 59,417 | 60,245 |
Section 174 capitalized research and development | 28,822 | 20,903 |
Stock-based compensation | 15,413 | 23,991 |
Lease liabilities | 1,471 | 2,052 |
Other | 5,005 | 3,693 |
Total gross deferred tax assets | 431,126 | 424,718 |
Deferred Tax Liabilities, Net [Abstract] | ||
Right-of-use lease assets | (1,362) | (1,914) |
Total gross deferred tax liabilities | (1,362) | (1,914) |
Valuation allowance | $ (429,764) | $ (422,804) |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) | 3 Months Ended | 12 Months Ended | ||
Jun. 30, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Operating Loss Carryforwards [Line Items] | ||||
Deferred Tax Assets, Tax Credit Carryforwards, Research | $ 59,417,000 | $ 60,245,000 | ||
Unrecognized Tax Benefits, Ending Balance | 10,903,000 | 11,235,000 | $ 9,631,000 | |
Unrecognized Tax Benefits, Income Tax Penalties and Interest Accrued, Total | $ 0 | |||
Tax cuts and jobs act, capitalize expense of amortized period for domestic expenses | 5 years | |||
Tax cuts and jobs act, capitalize expense of amortized period for foreign expenses | 15 years | |||
Tax cuts and jobs act, increased capitalized research expenses | $ 21,000,000 | |||
Employee Retention Credit | ||||
Operating Loss Carryforwards [Line Items] | ||||
Expected one-time refund amount | $ 6,000,000 | |||
One-time refund amount received | $ 6,000,000 | |||
Domestic Tax Authority | ||||
Operating Loss Carryforwards [Line Items] | ||||
Operating Loss Carryforwards, Total | 1,300,000,000 | |||
Expiring Operating Loss Carryforwards | $ 542,300,000 | |||
Net operating loss carryforwards expiration year | 2024 | |||
Indefinite Operating Loss Carryforwards | $ 755,700,000 | |||
Taxable income limitation percentage for operating loss carryforward | 80% | |||
Deferred Tax Assets, Tax Credit Carryforwards, Research | $ 44,600,000 | |||
Research and development credit carryforwards expiration year | 2024 | |||
State and Local Jurisdiction | ||||
Operating Loss Carryforwards [Line Items] | ||||
Operating Loss Carryforwards, Total | $ 879,100,000 | |||
Net operating loss carryforwards expiration year | 2028 | |||
Deferred Tax Assets, Tax Credit Carryforwards, Research | $ 21,700,000 |
Income Taxes - Summary of Unrec
Income Taxes - Summary of Unrecognized Tax Benefits (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | ||
Balance at beginning of year | $ 11,235 | $ 9,631 |
Increase (decrease) for tax positions of prior years | (332) | (200) |
Increase based on tax positions related to current year | 0 | 1,804 |
Balance at end of year | $ 10,903 | $ 11,235 |
Subsequent Event - Additional I
Subsequent Event - Additional Information (Details) - Subsequent Event - CrossLink Life Sciences, LLC | 1 Months Ended |
Jan. 31, 2024 Representative | |
Subsequent Event [Line Items] | |
Term of distributor partnership | 5 years |
Number of representatives added to sales network | 650 |