Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2024 | Aug. 01, 2024 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2024 | |
Document Fiscal Year Focus | 2024 | |
Document Fiscal Period Focus | Q2 | |
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 Filer Category | Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 151,668,017 | |
Entity Small Business | true | |
Entity Emerging Growth Company | 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 Quarterly Report | true | |
Document Transition Report | false | |
Title of 12(b) Security | Common Stock, par value $0.01 per share | |
Security Exchange Name | NASDAQ |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Current Period Unaudited) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Current assets: | ||
Cash and cash equivalents | $ 18,386 | $ 28,677 |
Short-term investments | 48,961 | 51,732 |
Accounts receivable, net | 73,708 | 60,137 |
Inventory | 42,864 | 42,110 |
Prepaid expenses and other current assets | 7,249 | 6,118 |
Total current assets | 191,168 | 188,774 |
Property and equipment, net | 15,900 | 20,166 |
Right-of-use lease assets | 4,138 | 5,438 |
Other assets | 6,930 | 8,128 |
Total assets | 218,136 | 222,506 |
Current liabilities: | ||
Accounts payable | 10,226 | 3,240 |
Accrued clinical and manufacturing liabilities | 17,554 | 22,291 |
Accrued payroll and employee liabilities | 7,085 | 9,224 |
Other accrued liabilities | 42,258 | 41,855 |
Current lease liabilities | 3,194 | 3,075 |
Total current liabilities | 80,317 | 79,685 |
Non-current lease liabilities | 1,289 | 2,800 |
Non-current notes payable, net | 24,634 | 24,263 |
Non-current convertible notes payable, net | 149,595 | 149,490 |
Other non-current liabilities | 241 | 241 |
Total liabilities | 256,076 | 256,479 |
Stockholders' deficit: | ||
Common stock | 1,516 | 1,503 |
Additional paid-in capital | 1,878,961 | 1,870,525 |
Accumulated other comprehensive (loss) income | (8) | 13 |
Accumulated deficit | (1,918,409) | (1,906,014) |
Total stockholders' deficit | (37,940) | (33,973) |
Total liabilities and stockholders' deficit | $ 218,136 | $ 222,506 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Revenues: | ||||
Net product sales | $ 36,024 | $ 31,762 | $ 70,694 | $ 61,377 |
Cost of product sales | 10,518 | 20,158 | 18,962 | 37,012 |
Gross Profit | 25,506 | 11,604 | 51,732 | 24,365 |
Operating expenses: | ||||
Research and development | 4,432 | 13,210 | 9,040 | 22,046 |
General and administrative | 13,905 | 19,592 | 28,879 | 35,426 |
Sales and marketing | 13,614 | 21,205 | 25,056 | 42,359 |
Total operating expenses | 31,951 | 54,007 | 62,975 | 99,831 |
Loss from operations | (6,445) | (42,403) | (11,243) | (75,466) |
Other (expense) income, net | (2,790) | 344 | (1,152) | 639 |
Net loss | (9,235) | (42,059) | (12,395) | (74,827) |
Other comprehensive loss: | ||||
Unrealized (losses) gains on short-term investments | (2) | (15) | (21) | 13 |
Comprehensive loss | $ (9,237) | $ (42,074) | $ (12,416) | $ (74,814) |
Basic net loss per common share | $ (0.06) | $ (0.35) | $ (0.08) | $ (0.63) |
Weighted average common shares outstanding, basic | 152,305 | 119,719 | 151,900 | 119,484 |
Diluted net loss per common share | $ (0.06) | $ (0.35) | $ (0.08) | $ (0.63) |
Weighted average common shares outstanding, diluted | 152,305 | 119,719 | 151,900 | 119,484 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Deficit (Unaudited) - USD ($) shares in Thousands, $ in Thousands | Total | Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit |
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 equity incentive plan | (208) | $ 2 | (210) | ||
Issuance of common stock under equity incentive plan (in shares) | 125 | ||||
Stock-based compensation expense | 7,947 | 7,947 | |||
Net loss | (32,768) | (32,768) | |||
Net unrealized gains (loss) on short-term investments | 28 | 28 | |||
Comprehensive loss | (32,740) | ||||
Balance at Mar. 31, 2023 | (11,429) | $ 1,193 | 1,815,592 | 9 | (1,828,223) |
Balance (in shares) at Mar. 31, 2023 | 119,280 | ||||
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 | ||||
Net loss | (74,827) | ||||
Net unrealized gains (loss) on short-term investments | 13 | ||||
Comprehensive loss | (74,814) | ||||
Balance at Jun. 30, 2023 | (39,284) | $ 1,199 | 1,829,805 | (6) | (1,870,282) |
Balance (in shares) at Jun. 30, 2023 | 119,956 | ||||
Balance at Mar. 31, 2023 | (11,429) | $ 1,193 | 1,815,592 | 9 | (1,828,223) |
Balance (in shares) at Mar. 31, 2023 | 119,280 | ||||
Issuance of common stock under equity incentive plan | (385) | $ 3 | (388) | ||
Issuance of common stock under equity incentive plan (in shares) | 330 | ||||
Issuance of common stock under the employee stock purchase plan | 704 | $ 3 | 701 | ||
Issuance of common stock under the employee stock purchase plan (in shares) | 346 | ||||
Stock-based compensation expense | 13,900 | 13,900 | |||
Net loss | (42,059) | (42,059) | |||
Net unrealized gains (loss) on short-term investments | (15) | (15) | |||
Comprehensive loss | (42,074) | ||||
Balance at Jun. 30, 2023 | (39,284) | $ 1,199 | 1,829,805 | (6) | (1,870,282) |
Balance (in shares) at Jun. 30, 2023 | 119,956 | ||||
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 | ||||
Issuance of common stock under equity incentive plan | 11 | $ 1 | 10 | ||
Issuance of common stock under equity incentive plan (in shares) | 93 | ||||
Stock-based compensation expense | 3,375 | 3,375 | |||
Net loss | (3,160) | (3,160) | |||
Net unrealized gains (loss) on short-term investments | (19) | (19) | |||
Comprehensive loss | (3,179) | ||||
Balance at Mar. 31, 2024 | (33,766) | $ 1,504 | 1,873,910 | (6) | (1,909,174) |
Balance (in shares) at Mar. 31, 2024 | 150,378 | ||||
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 | ||||
Net loss | (12,395) | ||||
Net unrealized gains (loss) on short-term investments | (21) | ||||
Comprehensive loss | (12,416) | ||||
Balance at Jun. 30, 2024 | (37,940) | $ 1,516 | 1,878,961 | (8) | (1,918,409) |
Balance (in shares) at Jun. 30, 2024 | 151,578 | ||||
Balance at Mar. 31, 2024 | (33,766) | $ 1,504 | 1,873,910 | (6) | (1,909,174) |
Balance (in shares) at Mar. 31, 2024 | 150,378 | ||||
Issuance of common stock under equity incentive plan | 318 | $ 9 | 309 | ||
Issuance of common stock under equity incentive plan (in shares) | 872 | ||||
Issuance of common stock under the employee stock purchase plan | 175 | $ 3 | 172 | ||
Issuance of common stock under the employee stock purchase plan (in shares) | 328 | ||||
Stock-based compensation expense | 4,570 | 4,570 | |||
Net loss | (9,235) | (9,235) | |||
Net unrealized gains (loss) on short-term investments | (2) | (2) | |||
Comprehensive loss | (9,237) | ||||
Balance at Jun. 30, 2024 | $ (37,940) | $ 1,516 | $ 1,878,961 | $ (8) | $ (1,918,409) |
Balance (in shares) at Jun. 30, 2024 | 151,578 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Operating activities: | ||
Net loss | $ (12,395) | $ (74,827) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation expense | 7,945 | 21,847 |
Depreciation and amortization | 1,330 | 1,457 |
Amortization of debt discount | 180 | 103 |
Amortization of debt issuance costs | 104 | |
Accretion of discount on short-term investments | (1,211) | (835) |
Impairment of property and equipment | 3,441 | 309 |
Loss on disposal of property and equipment | 23 | |
Change in operating assets and liabilities: | ||
Accounts receivable | (13,571) | (24,644) |
Inventory | (754) | 9,950 |
Prepaid expenses and other assets | 67 | 10,369 |
Accounts payable | 6,986 | (1,268) |
Accrued clinical and manufacturing liabilities | (4,605) | (4,587) |
Accrued payroll and employee liabilities | (2,139) | (3,560) |
Other accrued and other non-current liabilities | 502 | 13,598 |
Net cash used in operating activities | (14,120) | (52,065) |
Investing activities: | ||
Purchases of short-term investments | (65,100) | (28,381) |
Maturities and sales of short-term investments | 69,063 | 78,935 |
Purchases of property and equipment | (637) | (502) |
Net cash provided by investing activities | 3,326 | 50,052 |
Financing activities: | ||
Receipts (Payments) for stock issued under the equity incentive plan | 328 | (593) |
Proceeds from purchases under the employee stock purchase plan | 175 | 704 |
Net cash provided by financing activities | 503 | 111 |
Net decrease increase in cash and cash equivalents | (10,291) | (1,902) |
Cash and cash equivalents at beginning of year | 28,677 | 15,364 |
Cash and cash equivalents at end of period | 18,386 | 13,462 |
Supplemental disclosure of cash flow information: | ||
Interest paid | $ 2,426 | $ 1,125 |
Business
Business | 6 Months Ended |
Jun. 30, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Business | 1. 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 June 30, 2024 , we had cash, cash equivalents and short-term investments of $ 67.3 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 Quarterly Report on Form 10-Q is filed with the U.S. Securities and Exchange Commission (“SEC”). |
Basis of Presentation
Basis of Presentation | 6 Months Ended |
Jun. 30, 2024 | |
Accounting Policies [Abstract] | |
Basis of Presentation | 2. Basis of Presentation The accompanying condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and the requirements of the SEC for interim reporting. Accordingly, since they are interim statements, they do not include all of the information and disclosures required by GAAP for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation have been included. Operating results for the three and six months ended June 30, 2024 are not necessarily indicative of the results that may be expected for other quarters or the year ending December 31, 2024. The condensed consolidated balance sheet as of December 31, 2023 has been derived from the audited financial statements as of that date. For more complete financial information, these condensed consolidated financial statements and the notes thereto should be read in conjunction with the audited financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2023 , which was filed with the SEC on March 12, 2024. Reclassification of Certain Expense s The condensed consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 2023 reflect reclassification of certain expenses from research and development to general and administrative expenses to align with the Company's presentation for the three and six months ended June 30, 2024 as a result of the restructuring implemented in 2023 and the realignment of the Company's departments. This presentation results in no change to total operating expenses, loss from operations or net loss and no pro forma financial information is necessary. |
Accounting Policies
Accounting Policies | 6 Months Ended |
Jun. 30, 2024 | |
Accounting Policies [Abstract] | |
Accounting Policies | 3. Accounting Policies Principles of Consolidation The accompanying condensed 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 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 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 condensed 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 condensed 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 income (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 facility agreement (see Note 8). 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 with respect to our cash, cash equivalents and short-term investments, however, any loss incurred or a lack of access to such funds could have a significant adverse impact on the Company's 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 table 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 product sales: Net Product Sales Accounts Three Months Ended Six Months Ended As of Customer A (1) 46.0 % 45.1 % 45.7 % Customer B 34.6 % 36.2 % 35.1 % Customer C 18.3 % 17.7 % 18.8 % Total 98.9 % 99.0 % 99.6 % (1) Includes net product sales and accounts receivable balances for a subsidiary of Customer A that were reported separately in the Company’s Form 10-Q for the three months ended March 31, 2024, filed with the SEC on May 7, 2024. A ccounts 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. As of June 30, 2024, we do no t have an allowance for credit losses. 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. I nventory 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, N et 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. During the three months ended June 30, 2024 we incurred a loss on the write-off of property and equipment of $ 3.1 million, of which $ 2.5 million relates to a project for which we had a one-time settlement gain contingency related to a legal dispute, during the three months ended March 31, 2024. This loss was recorded to other (expense) income, net. The remaining loss was recorded to operating expenses. L eases 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 condensed 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. Rev enue Recognition Revenue is recognized in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customer s (“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 five 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 the majority of 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 costs 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 GPO's 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. The following table provides disaggregated net product sales (in thousands): For the Three Months Ended June 30, For the Six Months Ended June 30, 2024 2023 2024 2023 CINVANTI net product sales $ 24,927 $ 24,474 $ 50,544 $ 47,329 SUSTOL net product sales 4,246 2,836 7,860 5,819 ZYNRELEF net product sales 5,831 4,128 10,844 7,661 APONVIE net product sales 1,020 324 1,446 568 Total net product sales $ 36,024 $ 31,762 $ 70,694 $ 61,377 The following table provides a summary of activity with respect to our product returns, distributor fees and discounts, rebates and administrative fees, which are included in other accrued liabilities on the condensed consolidated balance sheets (in thousands): Product Distributor Discounts, Total Balance at December 31, 2023 $ 4,776 $ 4,419 $ 27,334 $ 36,529 Provision ( 1,216 ) 14,212 101,867 114,863 Payments/credits ( 517 ) ( 12,969 ) ( 100,890 ) ( 114,376 ) Balance at June 30, 2024 $ 3,043 $ 5,662 $ 28,311 $ 37,016 Co mprehensive Income (Loss) Comprehensive income (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 all periods presented. Ne t Loss per Share Basic net loss per share is calculated by dividing the net loss by the weighted-average number of shares of common stock 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 shares of common stock 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 all periods presented in the unaudited condensed 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): June 30, 2024 2023 Stock options outstanding 27,445 28,778 Restricted stock units outstanding 1,642 2,732 Warrants outstanding 298 8,548 Shares of common stock underlying convertible notes outstanding 9,819 9,819 Rec ent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies that we adopt as of the specified effective date. We have evaluated recently issued accounting pronouncements and do no t believe any will have a material impact on our condensed consolidated financial statements or related financial statement disclosures. In December 2023, the FASB issued Accounting Standards Update ("ASU") 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 | 6 Months Ended |
Jun. 30, 2024 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 4. 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 and 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 Prices Significant Significant Cash and money market funds $ 14,210 $ 14,210 $ — $ — U.S. Treasury bills and government agency obligations 31,634 31,634 — — U.S. corporate debt securities 11,202 — 11,202 — Foreign corporate debt securities 10,301 — 10,301 — Total $ 67,347 $ 45,844 $ 21,503 $ — Fair Value Measurements at Reporting Date Using Balance at Quoted Prices 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 $ — We have no t transferred any investment securities between the three levels of the fair value hierarchy for the three and six months ended June 30, 2024 or 2023. As of June 30, 2024 , cash equivalents included $ 4.2 million of available-for-sale securities with contractual maturities of three months or less and short-term investments included $ 19.1 million of available-for-sale securities with contractual maturities of three months to one year. 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. The money market funds as of June 30, 2024 and December 31, 2023 are included in cash and cash equivalents on the condensed consolidated balance sheets. 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, 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 notes payable and convertible notes payable outstanding at June 30, 2024 and December 31, 2023 do not have a readily available ascertainable market value; however, their carrying value, which is measured at carrying value less unamortized debt issuance costs and debt discounts, is considered to approximate their fair value. |
Short-Term Investments
Short-Term Investments | 6 Months Ended |
Jun. 30, 2024 | |
Short-Term Investments [Abstract] | |
Short-Term Investments | 5. Short-Term Investments The following is a summary of our short-term investments (in thousands): June 30, 2024 Gross Gross Amortized Unrealized Unrealized Estimated Cost Gains Losses Fair Value U.S. Treasury bills and government agency obligations $ 30,151 $ 1 $ ( 3 ) $ 30,149 U.S. corporate debt securities 8,513 — ( 2 ) 8,511 Foreign corporate debt securities 10,305 — ( 4 ) 10,301 Total $ 48,969 $ 1 $ ( 9 ) $ 48,961 December 31, 2023 Gross Gross Amortized Unrealized Unrealized Estimated Cost Gains Losses Fair Value 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 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 during the three and six months ended June 30, 2024 and 2023. Unrealized gains and losses associated with our investments are reported in accumulated other comprehensive income (loss). Realized gains and losses associated with our investments, if any, are reported in the statements of operations and comprehensive loss. We did no t recognize any realized gains or losses during the three and six months ended June 30, 2024 and 2023 . |
Inventory
Inventory | 6 Months Ended |
Jun. 30, 2024 | |
Inventory Disclosure [Abstract] | |
Inventory | 6. Inventory Inventory consists of the following (in thousands): June 30, 2024 December 31, 2023 Raw materials $ 19,594 $ 17,643 Work in process 16,051 14,550 Finished goods 7,219 9,917 Total inventory $ 42,864 $ 42,110 As of June 30, 2024 , total inventory included $ 28.9 million related to CINVANTI, $ 11.0 million related to ZYNRELEF, $ 2.9 million related to SUSTOL and $ 0.1 million related to APONVIE. As of December 31, 2023 , total inventory included $ 26.4 million related to CINVANTI, $ 11.2 million related to ZYNRELEF, $ 4.1 million related to SUSTOL and $ 0.4 million for APONVIE. For the three and six months ended June 30, 2024 , cost of product sales included charges of $ 1.6 million relating to reserves and write-offs of inventory. For the three and six months ended June 30, 2023 , cost of product sales included charges of $ 7.5 million and $ 12.8 million, respectively, relating to the write-off of inventory. |
Leases
Leases | 6 Months Ended |
Jun. 30, 2024 | |
Leases [Abstract] | |
Leases | 7. Leases As of June 30, 2024 , 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 five-year option to renew this lease on expiration applies only with respect to our remaining 28,275 square feet of laboratory and office space. We also have an operating lease through which we sublease 5,840 square feet of office space in Cary, North Carolina, with a lease term that expires on April 30, 2025 . During the three and six months ended June 30, 2024 , we recognized $ 0.7 million and $ 1.5 million of operating lease expense, respectively. During the three and six months ended June 30, 2024 , we paid $ 0.8 million and $ 1.6 million, respectively, for our operating leases. During the three and six months ended June 30, 2023 , we recognized $ 0.7 million and $ 1.4 million of operating lease expense, respectively. During the three and six months ended June 30, 2023 , we paid $ 1.0 million and $ 1.7 million, respectively, for our operating leases. Annual future minimum lease payments as of June 30, 2024 are as follows (in thousands): 2024 $ 1,578 2025 3,138 Total future minimum lease payments $ 4,716 Less: discount ( 233 ) Total lease liabilities $ 4,483 |
Long-Term Debt and Convertible
Long-Term Debt and Convertible Notes | 6 Months Ended |
Jun. 30, 2024 | |
Debt Disclosure [Abstract] | |
Long-Term Debt and Convertible Notes | 8. Long-Term Debt and 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 Notes (as defined below) (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, 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 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 "Lender Warrants"). The Lender Warrants are equal to 2.00 % of the principal amount of tranche 1A 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 Lender 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 $ 400.0 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 June 30, 2024. 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 Lender Warrants 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 Lender 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 three and six months ended June 30, 2024 , interest expense related to the Loan Agreement was $ 0.9 million and $ 1.8 million, respectively, which included $ 0.7 million and $ 1.3 million, respectively, related to the stated interest rate, $ 0.1 million and $ 0.2 million, respectively, related to paid-in-kind interest, and $ 0.2 million and $ 0.3 million, respectively, related to the amortization of the debt discounts. As of June 30, 2024 , the carrying value of tranche 1A was $ 24.6 million, which is comprised of the $ 25.0 million principal amount outstanding, $ 0.3 million of accumulated paid-in-kind interest, less debt discounts of $ 0.7 million. The end of term fee accreted as of June 30, 2024 of $ 0.2 million is recorded in other accrued liabilities on the condensed consolidated balance sheets. 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 (the “Notes”). We received a total of $ 149.0 million, net of issuance costs, from the issuance of the 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 and December 15 of each year, beginning on December 15, 2021 . The Notes mature on May 26, 2026 , unless earlier converted, redeemed or repurchased. The Notes are 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 will be subject to redemption at our option 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 common 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 condensed 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 condensed 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 three and six months ended June 30, 2024 , interest expense related to the Notes was $ 0.5 million and $ 1.1 million, respectively, which included $ 0.4 million and $ 1.0 million, respectively, related to the stated interest rate and $ 0.1 million and $ 0.1 million, respectively, related to the amortization of debt issuance costs. For the three and six months ended June 30, 2023 , interest expense related to the Notes was $ 0.6 million and $ 1.2 million, respectively, which included $ 0.6 million and $ 1.1 million, respectively, related to the stated interest rate and $ 51,000 and $ 0.1 million, respectively, related to the amortization of debt issuance costs. As of June 30, 2024 , the carrying value of the Notes was $ 149.6 million, which is comprised of the $ 150.0 million principal amount of the Notes outstanding, less debt issuance costs of $ 0.4 million. |
Stockholders' Equity
Stockholders' Equity | 6 Months Ended |
Jun. 30, 2024 | |
Equity [Abstract] | |
Stockholders' Equity | 9. Stockholders’ Deficit 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 "July 2023 Pre-Funded Warrants"). The July 2023 Pre-Funded Warrants have an exercise price of $ 0.0001 per share. The total net proceeds from the sale of the common stock and the July 2023 Pre-Funded Warrants was $ 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. |
Equity Incentive Plan
Equity Incentive Plan | 6 Months Ended |
Jun. 30, 2024 | |
Equity [Abstract] | |
Equity Incentive Plan | 10. Equity Incentive Plan Option Plan Activity The following table summarizes the stock option activity for the six months ended June 30, 2024: Shares Weighted- Weighted- Outstanding at December 31, 2023 24,575 $ 7.06 5.60 Granted 6,826 $ 2.23 Exercised ( 372 ) $ 2.46 Expired and forfeited ( 3,584 ) $ 11.17 Outstanding at June 30, 2024 27,445 $ 5.38 7.74 We estimated the fair value of each option grant on the grant date using the Black-Scholes option pricing model and for market-based stock option grants using the Monte Carlo simulation model. The following are the weighted-average assumptions: For the Six Months Ended June 30, 2024 2023 Risk-free interest rate 4.2 % 3.6 % Dividend yield 0.0 % 0.0 % Volatility 74.9 % 67.4 % Expected life (years) 6 to 10 6 to 10 We estimated the fair value of each purchase right granted under our 1997 Employee Stock Purchase Plan, as amended, at the beginning of each new offering period using the Black-Scholes option pricing model. The following are the weighted average assumptions: For the Six Months Ended June 30, 2024 2023 Risk-free interest rate 5.4 % 5.1 % Dividend yield 0.0 % 0.0 % Volatility 83.6 % 97.1 % Expected life (months) 6 6 The following table summarizes the restricted stock unit activity (“RSUs”) for the six months ended June 30, 2024: Shares Weighted-Average Grant Date Fair Value Outstanding at December 31, 2023 1,405 $ 4.43 Granted 1,482 $ 2.30 Released ( 829 ) $ 2.63 Expired and forfeited ( 415 ) $ 3.67 Outstanding at June 30, 2024 1,642 $ 2.97 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. Stock-Based Compensation The following table summarizes stock-based compensation expense related to stock-based payment awards granted pursuant to all of our equity compensation arrangements (in thousands): Three Months Ended Six Months Ended 2024 2023 2024 2023 Research and development $ 553 $ 2,694 $ 1,254 $ 4,430 General and administrative 2,060 6,925 3,938 10,457 Sales and marketing 1,957 4,281 2,753 6,960 Total stock-based compensation expense $ 4,570 $ 13,900 $ 7,945 $ 21,847 As of June 30, 2024 , there was $ 23.6 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 . |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2024 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 11. Income Taxes Deferred income tax assets and liabilities are recognized for temporary differences between financial statements and income tax carrying values using tax rates in effect for the years such differences are expected to reverse. Due to uncertainties surrounding our ability to generate future taxable income and consequently realize such deferred income tax assets, a full valuation allowance has been established. We continue to maintain a full valuation allowance against our deferred tax assets as of June 30, 2024. The impact of an uncertain income tax position on the income tax return must be recognized at the largest amount that is more likely than not to be sustained upon audit by the relevant tax authority. An uncertain income tax position will be recognized when it is more likely than not of being sustained. The disclosures regarding uncertain tax positions included in our Annual Report on Form 10-K for the year ended December 31, 2023, which was filed with the SEC on March 12, 2024, continue to be accurate for the three and six months ended June 30, 2024 . |
Accounting Policies (Policies)
Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2024 | |
Accounting Policies [Abstract] | |
Basis of Presentation | The accompanying condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and the requirements of the SEC for interim reporting. Accordingly, since they are interim statements, they do not include all of the information and disclosures required by GAAP for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation have been included. Operating results for the three and six months ended June 30, 2024 are not necessarily indicative of the results that may be expected for other quarters or the year ending December 31, 2024. The condensed consolidated balance sheet as of December 31, 2023 has been derived from the audited financial statements as of that date. For more complete financial information, these condensed consolidated financial statements and the notes thereto should be read in conjunction with the audited financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2023 , which was filed with the SEC on March 12, 2024. |
Reclassification of Certain Expenses | Reclassification of Certain Expense s The condensed consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 2023 reflect reclassification of certain expenses from research and development to general and administrative expenses to align with the Company's presentation for the three and six months ended June 30, 2024 as a result of the restructuring implemented in 2023 and the realignment of the Company's departments. This presentation results in no change to total operating expenses, loss from operations or net loss and no pro forma financial information is necessary. |
Principles of Consolidation | Principles of Consolidation The accompanying condensed 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 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 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 condensed 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 condensed 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 income (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 facility agreement (see Note 8). |
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 with respect to our cash, cash equivalents and short-term investments, however, any loss incurred or a lack of access to such funds could have a significant adverse impact on the Company's 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 table 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 product sales: Net Product Sales Accounts Three Months Ended Six Months Ended As of Customer A (1) 46.0 % 45.1 % 45.7 % Customer B 34.6 % 36.2 % 35.1 % Customer C 18.3 % 17.7 % 18.8 % Total 98.9 % 99.0 % 99.6 % (1) Includes net product sales and accounts receivable balances for a subsidiary of Customer A that were reported separately in the Company’s Form 10-Q for the three months ended March 31, 2024, filed with the SEC on May 7, 2024. |
Accounts Receivable, Net | A ccounts 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. As of June 30, 2024, we do no t have an allowance for credit losses. 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. |
Inventory | I nventory 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, Net | Property and Equipment, N et 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. During the three months ended June 30, 2024 we incurred a loss on the write-off of property and equipment of $ 3.1 million, of which $ 2.5 million relates to a project for which we had a one-time settlement gain contingency related to a legal dispute, during the three months ended March 31, 2024. This loss was recorded to other (expense) income, net. The remaining loss was recorded to operating expenses. |
Leases | L eases 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 condensed 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 | Rev enue Recognition Revenue is recognized in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customer s (“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 five 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 the majority of 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 costs 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 GPO's 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. The following table provides disaggregated net product sales (in thousands): For the Three Months Ended June 30, For the Six Months Ended June 30, 2024 2023 2024 2023 CINVANTI net product sales $ 24,927 $ 24,474 $ 50,544 $ 47,329 SUSTOL net product sales 4,246 2,836 7,860 5,819 ZYNRELEF net product sales 5,831 4,128 10,844 7,661 APONVIE net product sales 1,020 324 1,446 568 Total net product sales $ 36,024 $ 31,762 $ 70,694 $ 61,377 The following table provides a summary of activity with respect to our product returns, distributor fees and discounts, rebates and administrative fees, which are included in other accrued liabilities on the condensed consolidated balance sheets (in thousands): Product Distributor Discounts, Total Balance at December 31, 2023 $ 4,776 $ 4,419 $ 27,334 $ 36,529 Provision ( 1,216 ) 14,212 101,867 114,863 Payments/credits ( 517 ) ( 12,969 ) ( 100,890 ) ( 114,376 ) Balance at June 30, 2024 $ 3,043 $ 5,662 $ 28,311 $ 37,016 |
Comprehensive Income (Loss) | Co mprehensive Income (Loss) Comprehensive income (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 all periods presented. |
Net Loss per Share | Ne t Loss per Share Basic net loss per share is calculated by dividing the net loss by the weighted-average number of shares of common stock 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 shares of common stock 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 all periods presented in the unaudited condensed 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): June 30, 2024 2023 Stock options outstanding 27,445 28,778 Restricted stock units outstanding 1,642 2,732 Warrants outstanding 298 8,548 Shares of common stock underlying convertible notes outstanding 9,819 9,819 |
Recent Accounting Pronouncements | Rec ent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies that we adopt as of the specified effective date. We have evaluated recently issued accounting pronouncements and do no t believe any will have a material impact on our condensed consolidated financial statements or related financial statement disclosures. In December 2023, the FASB issued Accounting Standards Update ("ASU") 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. |
Accounting Policies (Tables)
Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Accounting Policies [Abstract] | |
Percentage of Product Sales and Accounts Receivable Balance | The following table 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 product sales: Net Product Sales Accounts Three Months Ended Six Months Ended As of Customer A (1) 46.0 % 45.1 % 45.7 % Customer B 34.6 % 36.2 % 35.1 % Customer C 18.3 % 17.7 % 18.8 % Total 98.9 % 99.0 % 99.6 % (1) Includes net product sales and accounts receivable balances for a subsidiary of Customer A that were reported separately in the Company’s Form 10-Q for the three months ended March 31, 2024, filed with the SEC on May 7, 2024. |
Schedule of Disaggregated Net Product Sales | The following table provides disaggregated net product sales (in thousands): For the Three Months Ended June 30, For the Six Months Ended June 30, 2024 2023 2024 2023 CINVANTI net product sales $ 24,927 $ 24,474 $ 50,544 $ 47,329 SUSTOL net product sales 4,246 2,836 7,860 5,819 ZYNRELEF net product sales 5,831 4,128 10,844 7,661 APONVIE net product sales 1,020 324 1,446 568 Total net product sales $ 36,024 $ 31,762 $ 70,694 $ 61,377 |
Summary of Activity to Product Returns, Distributor Fees and Discounts, Rebates and Administrative Fees | The following table provides a summary of activity with respect to our product returns, distributor fees and discounts, rebates and administrative fees, which are included in other accrued liabilities on the condensed consolidated balance sheets (in thousands): Product Distributor Discounts, Total Balance at December 31, 2023 $ 4,776 $ 4,419 $ 27,334 $ 36,529 Provision ( 1,216 ) 14,212 101,867 114,863 Payments/credits ( 517 ) ( 12,969 ) ( 100,890 ) ( 114,376 ) Balance at June 30, 2024 $ 3,043 $ 5,662 $ 28,311 $ 37,016 |
Common Stock Equivalents Excluded From Computation of Net Loss Per Share | Because we have incurred a net loss for all periods presented in the unaudited condensed 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): June 30, 2024 2023 Stock options outstanding 27,445 28,778 Restricted stock units outstanding 1,642 2,732 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) | 6 Months Ended |
Jun. 30, 2024 | |
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 Prices Significant Significant Cash and money market funds $ 14,210 $ 14,210 $ — $ — U.S. Treasury bills and government agency obligations 31,634 31,634 — — U.S. corporate debt securities 11,202 — 11,202 — Foreign corporate debt securities 10,301 — 10,301 — Total $ 67,347 $ 45,844 $ 21,503 $ — Fair Value Measurements at Reporting Date Using Balance at Quoted Prices 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 $ — |
Short-Term Investments (Tables)
Short-Term Investments (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Short-Term Investments [Abstract] | |
Summary of Short-Term Investments | The following is a summary of our short-term investments (in thousands): June 30, 2024 Gross Gross Amortized Unrealized Unrealized Estimated Cost Gains Losses Fair Value U.S. Treasury bills and government agency obligations $ 30,151 $ 1 $ ( 3 ) $ 30,149 U.S. corporate debt securities 8,513 — ( 2 ) 8,511 Foreign corporate debt securities 10,305 — ( 4 ) 10,301 Total $ 48,969 $ 1 $ ( 9 ) $ 48,961 December 31, 2023 Gross Gross Amortized Unrealized Unrealized Estimated Cost Gains Losses Fair Value 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 |
Inventory (Tables)
Inventory (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory | Inventory consists of the following (in thousands): June 30, 2024 December 31, 2023 Raw materials $ 19,594 $ 17,643 Work in process 16,051 14,550 Finished goods 7,219 9,917 Total inventory $ 42,864 $ 42,110 |
Leases (Tables)
Leases (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Leases [Abstract] | |
Summary of Future Minimum Lease Payments | Annual future minimum lease payments as of June 30, 2024 are as follows (in thousands): 2024 $ 1,578 2025 3,138 Total future minimum lease payments $ 4,716 Less: discount ( 233 ) Total lease liabilities $ 4,483 |
Equity Incentive Plan (Tables)
Equity Incentive Plan (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Equity [Abstract] | |
Summary of Stock Option Activity | The following table summarizes the stock option activity for the six months ended June 30, 2024: Shares Weighted- Weighted- Outstanding at December 31, 2023 24,575 $ 7.06 5.60 Granted 6,826 $ 2.23 Exercised ( 372 ) $ 2.46 Expired and forfeited ( 3,584 ) $ 11.17 Outstanding at June 30, 2024 27,445 $ 5.38 7.74 |
Summary of Fair Value of Option Grant on Grant Date and Employee Stock Purchase Plan Using Black-Scholes Option Pricing Model and Market Based Stock Option Grants Monte Carlo Simulation Model | We estimated the fair value of each option grant on the grant date using the Black-Scholes option pricing model and for market-based stock option grants using the Monte Carlo simulation model. The following are the weighted-average assumptions: For the Six Months Ended June 30, 2024 2023 Risk-free interest rate 4.2 % 3.6 % Dividend yield 0.0 % 0.0 % Volatility 74.9 % 67.4 % Expected life (years) 6 to 10 6 to 10 We estimated the fair value of each purchase right granted under our 1997 Employee Stock Purchase Plan, as amended, at the beginning of each new offering period using the Black-Scholes option pricing model. The following are the weighted average assumptions: For the Six Months Ended June 30, 2024 2023 Risk-free interest rate 5.4 % 5.1 % Dividend yield 0.0 % 0.0 % Volatility 83.6 % 97.1 % Expected life (months) 6 6 |
Summary of Restricted Stock Unit Activity | The following table summarizes the restricted stock unit activity (“RSUs”) for the six months ended June 30, 2024: Shares Weighted-Average Grant Date Fair Value Outstanding at December 31, 2023 1,405 $ 4.43 Granted 1,482 $ 2.30 Released ( 829 ) $ 2.63 Expired and forfeited ( 415 ) $ 3.67 Outstanding at June 30, 2024 1,642 $ 2.97 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. |
Summary of Stock-Based Compensation Expense related to Stock-Based Payment Awards Granted | The following table summarizes stock-based compensation expense related to stock-based payment awards granted pursuant to all of our equity compensation arrangements (in thousands): Three Months Ended Six Months Ended 2024 2023 2024 2023 Research and development $ 553 $ 2,694 $ 1,254 $ 4,430 General and administrative 2,060 6,925 3,938 10,457 Sales and marketing 1,957 4,281 2,753 6,960 Total stock-based compensation expense $ 4,570 $ 13,900 $ 7,945 $ 21,847 |
Business - Additional Informati
Business - Additional Information (Details) $ in Millions | Jun. 30, 2024 USD ($) |
Business [Line Items] | |
Cash, cash equivalents and short-term investments | $ 67.3 |
Accounting Policies - Percentag
Accounting Policies - Percentage of Product Sales and Accounts Receivable Balance (Details) - Customer Concentration Risk | 3 Months Ended | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2024 | ||
Revenue Benchmark | Largest Customer | |||
Product Information [Line Items] | |||
Concentration risk percentage | [1] | 46% | 45.10% |
Revenue Benchmark | Second Largest Customer | |||
Product Information [Line Items] | |||
Concentration risk percentage | 34.60% | 36.20% | |
Revenue Benchmark | Third Largest Customer | |||
Product Information [Line Items] | |||
Concentration risk percentage | 18.30% | 17.70% | |
Revenue Benchmark | Total Customer | |||
Product Information [Line Items] | |||
Concentration risk percentage | 98.90% | 99% | |
Accounts Receivable | Largest Customer | |||
Product Information [Line Items] | |||
Concentration risk percentage | [1] | 45.70% | |
Accounts Receivable | Second Largest Customer | |||
Product Information [Line Items] | |||
Concentration risk percentage | 35.10% | ||
Accounts Receivable | Third Largest Customer | |||
Product Information [Line Items] | |||
Concentration risk percentage | 18.80% | ||
Accounts Receivable | Total Customer | |||
Product Information [Line Items] | |||
Concentration risk percentage | 99.60% | ||
[1] Includes net product sales and accounts receivable balances for a subsidiary of Customer A that were reported separately in the Company’s Form 10-Q for the three months ended March 31, 2024, filed with the SEC on May 7, 2024. |
Accounting Policies - Additiona
Accounting Policies - Additional Information (Details) - USD ($) | 3 Months Ended | |
Jun. 30, 2024 | Mar. 31, 2024 | |
Product Information [Line Items] | ||
Allowance for credit losses | $ 0 | |
Property, Plant, and Equipment, Useful Life, Term, Description [Extensible Enumeration] | us-gaap:UsefulLifeTermOfLeaseMember | |
Write-off of property and equipment incurred loss | $ 3,100,000 | |
Gain contingency settlement of legal dispute | $ 2,500,000 | |
Accounting Standards Update 2020-06 | ||
Product Information [Line Items] | ||
Change in accounting principle, accounting standards update, immaterial effect | true |
Accounting Policies - Summary o
Accounting Policies - Summary of Disaggregated Net Product Sales (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Product Information [Line Items] | ||||
Net product sales | $ 36,024 | $ 31,762 | $ 70,694 | $ 61,377 |
CINVANTI | ||||
Product Information [Line Items] | ||||
Net product sales | 24,927 | 24,474 | 50,544 | 47,329 |
SUSTOL | ||||
Product Information [Line Items] | ||||
Net product sales | 4,246 | 2,836 | 7,860 | 5,819 |
ZYNRELEF | ||||
Product Information [Line Items] | ||||
Net product sales | 5,831 | 4,128 | 10,844 | 7,661 |
APONVIE | ||||
Product Information [Line Items] | ||||
Net product sales | $ 1,020 | $ 324 | $ 1,446 | $ 568 |
Accounting Policies - Summary_2
Accounting Policies - Summary of Activity to Product Returns, Distributor Fees and Discounts, Rebates and Administrative Fees (Details) $ in Thousands | 6 Months Ended |
Jun. 30, 2024 USD ($) | |
Product Information [Line Items] | |
Balance | $ 36,529 |
Provision | 114,863 |
Payments/credits | (114,376) |
Balance | 37,016 |
Product Returns | |
Product Information [Line Items] | |
Balance | 4,776 |
Provision | (1,216) |
Payments/credits | (517) |
Balance | 3,043 |
Distributor Fees | |
Product Information [Line Items] | |
Balance | 4,419 |
Provision | 14,212 |
Payments/credits | (12,969) |
Balance | 5,662 |
Discounts, Rebates and Administrative Fees | |
Product Information [Line Items] | |
Balance | 27,334 |
Provision | 101,867 |
Payments/credits | (100,890) |
Balance | $ 28,311 |
Accounting Policies - Common St
Accounting Policies - Common Stock Equivalents Excluded From Computation of Net Loss Per Share (Details) - shares shares in Thousands | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Share-based Payment Arrangement, Option | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Shares excluded (in shares) | 27,445 | 28,778 |
Restricted Stock Units | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Shares excluded (in shares) | 1,642 | 2,732 |
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 | Jun. 30, 2024 | Dec. 31, 2023 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | $ 48,961 | $ 51,732 |
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 | 30,149 | 31,636 |
U.S. Corporate Debt | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 8,511 | 11,653 |
Foreign Corporate Debt | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 10,301 | 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 | |
Fair Value, Recurring | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total | 67,347 | 80,409 |
Fair Value, Recurring | Foreign Commercial Paper | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 993 | |
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 | 31,634 | 31,636 |
Fair Value, Recurring | U.S. Corporate Debt | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 11,202 | 16,889 |
Fair Value, Recurring | Foreign Corporate Debt | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 10,301 | 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 | |
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 | 14,210 | 23,441 |
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 | 45,844 | 55,077 |
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 | 31,634 | 31,636 |
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 | 14,210,000 | 23,441 |
Fair Value, Recurring | Significant Other Observable Inputs (Level 2) | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total | 21,503 | 25,332 |
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 | |
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 | 11,202 | 16,889 |
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 | $ 10,301 | 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 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) - USD ($) | 3 Months Ended | ||
Mar. 31, 2024 | Jun. 30, 2024 | Dec. 31, 2023 | |
Fair Value Disclosures [Abstract] | |||
Financial instruments transferred among fair value hierarchy levels | $ 0 | ||
Cash equivalents included of available-for-sale securities | $ 4,200,000 | $ 5,300,000 | |
Available for sale securities with contractual maturities of three months to one year. | $ 19,100,000 | $ 51,700,000 |
Short-term Investments - Summar
Short-term Investments - Summary of Short-term Investments (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Schedule Of Available For Sale Securities [Line Items] | ||
Available-for-sale securities, amortized cost | $ 48,969 | $ 51,720 |
Available-for-sale securities, gross unrealized gains | 1 | 13 |
Available-for-sale securities, gross unrealized losses | (9) | (1) |
Available-for-sale securities | 48,961 | 51,732 |
U.S. Treasury Bills and Government Agency Obligations | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Available-for-sale securities, amortized cost | 30,151 | 31,625 |
Available-for-sale securities, gross unrealized gains | 1 | 11 |
Available-for-sale securities, gross unrealized losses | (3) | |
Available-for-sale securities | 30,149 | 31,636 |
U.S. Corporate Debt | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Available-for-sale securities, amortized cost | 8,513 | 11,652 |
Available-for-sale securities, gross unrealized gains | 1 | |
Available-for-sale securities, gross unrealized losses | (2) | |
Available-for-sale securities | 8,511 | 11,653 |
Foreign Corporate Debt | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Available-for-sale securities, amortized cost | 10,305 | 5,459 |
Available-for-sale securities, gross unrealized gains | 0 | 1 |
Available-for-sale securities, gross unrealized losses | (4) | |
Available-for-sale securities | $ 10,301 | 5,460 |
U.S. Commercial Paper | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Available-for-sale securities, amortized cost | 1,991 | |
Available-for-sale securities, gross unrealized losses | (1) | |
Available-for-sale securities | 1,990 | |
Foreign Commercial Paper | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Available-for-sale securities, amortized cost | 993 | |
Available-for-sale securities | $ 993 |
Short-Term Investments - Additi
Short-Term Investments - Additional Information (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Short-Term Investments [Abstract] | ||||
Debt securities, impairment losses | $ 0 | $ 0 | $ 0 | $ 0 |
Debt securities, available-for-sale, realized gain (loss) | $ 0 | $ 0 | $ 0 | $ 0 |
Inventory - Schedule of Invento
Inventory - Schedule of Inventory (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 19,594 | $ 17,643 |
Work in process | 16,051 | 14,550 |
Finished goods | 7,219 | 9,917 |
Total inventory | $ 42,864 | $ 42,110 |
Inventory - Additional Informat
Inventory - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Mar. 31, 2024 | Dec. 31, 2023 | |
Inventory [Line Items] | ||||||
Total inventory | $ 42,864 | $ 42,864 | $ 42,110 | |||
Cost of product sales, charges | 1,600 | $ 7,500 | 1,600 | $ 12,800 | ||
CINVANTI | ||||||
Inventory [Line Items] | ||||||
Total inventory | 28,900 | 28,900 | 26,400 | |||
ZYNRELEF | ||||||
Inventory [Line Items] | ||||||
Total inventory | 11,000 | 11,000 | 11,200 | |||
SUSTOL | ||||||
Inventory [Line Items] | ||||||
Total inventory | $ 2,900 | $ 2,900 | 4,100 | |||
APONVIE | ||||||
Inventory [Line Items] | ||||||
Total inventory | $ 100 | $ 400 |
Leases - Additional Information
Leases - Additional Information (Details) $ in Millions | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2024 USD ($) ft² | Jun. 30, 2023 USD ($) | Jun. 30, 2024 USD ($) ft² | Jun. 30, 2023 USD ($) | Oct. 31, 2021 ft² | |
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 | 52,148 | |||
Lease expiration date | Dec. 31, 2025 | ||||
Remaining area of real estate property | ft² | 28,275 | 28,275 | 28,275 | ||
Lessee, operating lease, existence of option to extend | true | ||||
Operating lease expense | $ | $ 0.7 | $ 0.7 | $ 1.5 | $ 1.4 | |
Operating lease cash payments | $ | 0.8 | $ 1 | 1.6 | $ 1.7 | |
Cary, North Carolina | |||||
Lessee Lease Description [Line Items] | |||||
Operating lease expense | $ | 0.7 | 1.5 | |||
Operating lease cash payments | $ | $ 0.8 | $ 1.6 | |||
Cary, North Carolina | Sublease Agreement | |||||
Lessee Lease Description [Line Items] | |||||
Area of real estate property | ft² | 5,840 | 5,840 | |||
Lease expiration date | Apr. 30, 2025 |
Leases - Summary of Future Mini
Leases - Summary of Future Minimum Lease Payments (Details) $ in Thousands | Jun. 30, 2024 USD ($) |
Leases [Abstract] | |
2024 | $ 1,578 |
2025 | 3,138 |
Total future minimum lease payments | 4,716 |
Less: discount | (233) |
Total lease liabilities | $ 4,483 |
Long-Term Debt and Convertibl_2
Long-Term Debt and Convertible Notes - Additional Information (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||
Aug. 15, 2023 | Aug. 09, 2023 | May 31, 2021 | Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Debt Instrument [Line Items] | |||||||
Amortization of debt issuance costs | $ 104,000 | ||||||
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 Notes (as defined below) (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 | 180,000 | $ 103,000 | |||||
Other Accrued Liabilities | |||||||
Debt Instrument [Line Items] | |||||||
Term fee accreted | $ 200,000 | 200,000 | |||||
Common Stock | |||||||
Debt Instrument [Line Items] | |||||||
Initial conversion price/rate | $ 15.276 | ||||||
Tranche 1A | 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 | 900,000 | 1,800,000 | |||||
Interest expense, debt, excluding amortization | 700,000 | 1,300,000 | |||||
Paid-in-kind interest amount | 100,000 | 200,000 | |||||
Amortization of debt discount | $ 800,000 | 200,000 | 300,000 | ||||
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 | 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 | ||||||
Paid-in-kind interest amount | 300,000 | ||||||
Carrying value of debt | 24,600,000 | 24,600,000 | |||||
Debt instrument, face amount | $ 25,000,000 | 25,000,000 | 25,000,000 | ||||
Debt issuance costs | 700,000 | 700,000 | |||||
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 | $ 100,000 | $ 51,000 | 100,000 | 100,000 | |||
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% | 1.60% | |||||
Interest expense | $ 500,000 | 600,000 | $ 1,100,000 | 1,200,000 | |||
Interest expense, debt, excluding amortization | 400,000 | $ 600,000 | 1,000,000 | $ 1,100,000 | |||
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 | $ 65.462 | ||||||
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 | 149,600,000 | 149,600,000 | |||||
Debt instrument, face amount | 150,000,000 | 150,000,000 | |||||
Debt issuance costs | $ 400,000 | $ 400,000 | |||||
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 Millions, $ in Millions | Aug. 31, 2023 | Jul. 21, 2023 |
Class Of Stock [Line Items] | ||
Common shares registered for resale | 21.9 | |
Pre-funded Warrants | ||
Class Of Stock [Line Items] | ||
Purchase price per share | $ 1.3699 | |
Class of warrant or right, number of securities called by warrants or rights | 1.2 | |
Class of warrant or right, exercise price of warrants or rights | $ 0.0001 | |
2023 Private Placement | ||
Class Of Stock [Line Items] | ||
Shares of common stock sold | 20.7 | |
Purchase price per share | $ 1.37 | |
Proceeds from issuance of common stock and pre-funded warrants | $ 29.8 | |
Stock issuance cost | $ 0.2 |
Equity Incentive Plan - Summary
Equity Incentive Plan - Summary of Stock Option Activity (Details) - $ / shares shares in Thousands | 6 Months Ended | 12 Months Ended |
Jun. 30, 2024 | Dec. 31, 2023 | |
Equity [Abstract] | ||
Number of shares outstanding | 24,575 | |
Number of shares granted | 6,826 | |
Number of shares exercised | (372) | |
Number of shares expired and forfeited | (3,584) | |
Number of shares outstanding | 27,445 | 24,575 |
Weighted-Average Exercise Price, outstanding | $ 7.06 | |
Weighted-Average Exercise Price, granted | 2.23 | |
Weighted-Average Exercise Price, exercised | 2.46 | |
Weighted-Average Exercise Price, expired and forfeited | 11.17 | |
Weighted-Average Exercise Price, outstanding | $ 5.38 | $ 7.06 |
Weighted-Average Remaining Contractual Term (Years) | 7 years 8 months 26 days | 5 years 7 months 6 days |
Equity Incentive Plan - Summa_2
Equity Incentive Plan - Summary of Fair Value of Option Grant on Grant Date and Employee Stock Purchase Plan Using Black-Scholes Option Pricing Model and Market Based Stock Option Grants Monte Carlo Simulation Model (Details) | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Share-based Payment Arrangement, Option | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Risk-free interest rate | 4.20% | 3.60% |
Dividend yield | 0% | 0% |
Volatility | 74.90% | 67.40% |
Share-based Payment Arrangement, Option | Minimum | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected life | 6 years | 6 years |
Share-based Payment Arrangement, Option | Maximum | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected life | 10 years | 10 years |
Employee Stock Purchase Plan | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Risk-free interest rate | 5.40% | 5.10% |
Dividend yield | 0% | 0% |
Volatility | 83.60% | 97.10% |
Expected life | 6 months | 6 months |
Equity Incentive Plan - Summa_3
Equity Incentive Plan - Summary of Restricted Stock Unit Activity (Details) - Restricted Stock Units shares in Thousands | 6 Months Ended |
Jun. 30, 2024 $ / shares shares | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Number of shares outstanding | shares | 1,405 |
Number of shares granted | shares | 1,482 |
Number of shares released | shares | (829) |
Number of shares expired and forfeited | shares | (415) |
Number of shares outstanding | shares | 1,642 |
Weighted-Average Grant Date Fair Value, outstanding | $ / shares | $ 4.43 |
Weighted-Average Grant Date Fair Value, granted | $ / shares | 2.3 |
Weighted-Average Grant Date Fair Value, released | $ / shares | 2.63 |
Weighted-Average Grant Date Fair Value, expired and forfeited | $ / shares | 3.67 |
Weighted-Average Grant Date Fair Value, outstanding | $ / shares | $ 2.97 |
Equity Incentive Plan - Additio
Equity Incentive Plan - Additional Information (Details) $ in Millions | 6 Months Ended |
Jun. 30, 2024 USD ($) | |
Class Of Stock [Line Items] | |
Total unrecognized compensation cost related to non-vested, stock-based payment awards | $ 23.6 |
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 |
Equity Incentive Plan - Summa_4
Equity Incentive Plan - Summary of Stock-Based Compensation Expense related to Stock-Based Payment Awards Granted (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 4,570 | $ 13,900 | $ 7,945 | $ 21,847 |
Research and Development Expense | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Stock-based compensation expense | 553 | 2,694 | 1,254 | 4,430 |
General and Administrative Expense | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Stock-based compensation expense | 2,060 | 6,925 | 3,938 | 10,457 |
Sales and Marketing Expense | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 1,957 | $ 4,281 | $ 2,753 | $ 6,960 |