HERON THERAPEUTICS, INC. /DE/
For the period ended Sep 30, 2026. Filed Nov 9, 2026.
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Sep 30, 2026 · Filed Nov 9, 2026
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Notes to Condensed Consolidated Financial Statements (Unaudited)
Notes to Condensed Consoli dated Financial Statements
- 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") is approved in the U.S. for the prevention of chemotherapy-induced nausea and vomiting. SUSTOL® (granisetron) extended-release injection ("SUSTOL") is also approved in the U.S. for the prevention of chemotherapy-induced nausea and vomiting. As of September 30, 2026, we have ceased distribution of SUSTOL.
Liquidity and Going Concern
In accordance with Accounting Standards Update ("ASU") No. 2014-15, Disclosure of Uncertainties about an Entity's Ability to Continue as a Going Concern (Subtopic 205-40), we have evaluated whether there are conditions or events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern for a period of at least one year from the date of issuance of the condensed consolidated financial statements included in this Quarterly Report on Form 10-Q.
From our inception through September 30, 2026, we have financed our operations, including technology and product research and development, primarily through issuances of our common stock, convertible notes and warrants, product sales and debt financings.
As of September 30, 2026, we had cash, cash equivalents and short-term investments of $23.4 million. Based on our current operating plan and projections, management believes that our cash, cash equivalents and short-term investments will be sufficient to meet our anticipated cash requirements for operations for at least one year from the date of issuance of the condensed consolidated financial statements included in this Quarterly Report on Form 10-Q. However, our Working Capital Facility Agreement (as described further below), contains a minimum cash covenant, a minimum revenue covenant and a minimum EBITDA covenant. Based on our results of operations for the nine months ended September 30, 2026 and without additional funding, from the closing of the Asset Sale or otherwise, there is a possibility we may not satisfy one or more covenants under our Working Capital Facility Agreement within the next twelve months, absent a waiver, consent or amendment under our Working Capital Facility Agreement. If an event of default occurs under the Working Capital Facility Agreement due to the failure to satisfy certain covenants, our lenders could declare all outstanding principal, together with accrued and unpaid interest and end of term fee, to be immediately due and payable. If the payment of the debt is accelerated, absent any additional funding, cash flows from our operations will be insufficient to repay such debt in full. Therefore, if all outstanding amounts under the Working Capital Facility Agreement are accelerated, management expects there will be substantial doubt about our ability to continue as a going concern for a period of at least one year from the date of issuance of the condensed consolidated financial statements included in this Quarterly Report on Form 10-Q. If an event of default occurs under the note purchase agreement in connection with the 2031 Convertible Notes ("the 2031 Convertible Notes Purchase Agreement") due to the acceleration of all outstanding amounts under the Working Capital Facility Agreement, the required purchasers under the 2031 Convertible Notes Purchase Agreement could also declare the acceleration of all outstanding amounts under the 2031 Convertible Notes, subject to applicable notice requirements and cure periods.
Pursuant to the Asset Purchase Agreement, a portion of the cash consideration in the Asset Sale will be used to repay all amounts outstanding under the Working Capital Facility Agreement. A portion of the stock consideration in the Asset Sale will be used to exchange all or a portion of the outstanding 2031 Convertible Notes as described in Note 8 - Long-Term Debt and Convertible Notes. The completion of the Asset Sale is subject to approval by the Company's stockholders and the satisfaction of other customary closing conditions, and there can be no assurance that the Company will be successful in obtaining stockholder approval or closing the Asset Sale on the anticipated timeline, on the terms currently contemplated, or at all.
- 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 thethree and nine months ended September 30, 2026, are not necessarily indicative of the results that may be expected for other quarters or the year ending December 31, 2026. The condensed consolidated balance sheet as of December 31, 2025 has been derived from the audited consolidated financial statements as of that date. For more complete financial information, these condensed consolidated financial statements and the related notes thereto should be read in conjunction with the audited consolidated financial statements included in our 2025 Annual Report.
- 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 and manufacturing liabilities, income taxes, stock-based compensation and accounting for debt and equity transactions. 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 loss and realized gains and losses included in other 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 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 - Long-Term Debt and Convertible Notes).
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 our financial condition, results of operations and cash flows.
We may also invest our excess cash in money market funds, U.S. government and agencies, corporate debt securities and commercial paper. We have established guidelines relative to the 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 and CINVANTI are, and until September 30, 2026, SUSTOL was, 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 · AccountsReceivable | |||
|---|---|---|---|
| Three Months EndedSeptember 30, 2026 | Nine Months EndedSeptember 30, 2026 | As ofSeptember 30, 2026 | |
| Customer A | 38.0% | 38.3% | 39.2% |
| Customer B | 32.8% | 33.2% | 32.8% |
| Customer C | 26.6% | 26.1% | 25.7% |
| Total | 97.4% | 97.6% | 97.7% |
Accounts Receivable, Net
Accounts receivable are recorded at the invoice amount, net of an allowance for credit losses. The allowance for credit losses reflects accounts receivable balances that are believed to be uncollectible. In estimating the allowance for credit losses, we consider (1) our historical experience with collections and write-offs; (2) the credit quality of our Customers and any recent or anticipated changes thereto; (3) the outstanding balances and past due amounts from our Customers; and (4) reasonable and supportable forecasts of economic conditions expected to exist throughout the contractual term of the receivable. As of September 30, 2026, and December 31, 2025, we donot have an allowance for credit losses.
Inventory, Net
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 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.
Leases
We determine if an arrangement is a lease or contains lease components at inception. Operating leases with an initial term greater than 12 months are recorded as lease liabilities with corresponding right-of-use ("ROU") lease assets on the 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
Revenue is recognized in accordance with Financial Accounting Standards Board ("FASB") Accounting Standards Codification ("ASC") Topic 606, Revenue from Contracts with Customers ("Topic 606"). Topic 606 is based on the principle that revenue should be recognized to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services.
Product Sales
Our Products are distributed in the U.S. through a limited number of Customers that resell to healthcare providers and hospitals, the end users of our Products.
Revenue is recognized in an amount that reflects the consideration we expect to receive in exchange for our Products. To determine revenue recognition for contracts with Customers within the scope of Topic 606, we perform the following 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):
| Three Months EndedSeptember 30, | Nine Months EndedSeptember 30, | |||
|---|---|---|---|---|
| 2026 | 2025 | 2026 | 2025 | |
| CINVANTI net product sales | $19,970 | $23,955 | $62,298 | $73,841 |
| SUSTOL net product sales | 152 | 1,911 | 1,241 | 7,175 |
| ZYNRELEF net product sales | 10,598 | 9,313 | 31,888 | 25,542 |
| APONVIE net product sales | 4,530 | 3,034 | 12,200 | 7,758 |
| Total net product sales | $35,250 | $38,213 | $107,627 | $114,316 |
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):
| ProductReturns | DistributorFees | Discounts,Rebates andAdministrative Fees | Total | |
|---|---|---|---|---|
| Balance at December 31, 2025 | $4,515 | $7,328 | $34,152 | $45,995 |
| Provision | 2,735 | 26,356 | 170,807 | 199,898 |
| Payments/credits | (945) | (26,965) | (170,252) | (198,162) |
| Balance at September 30, 2026 | $6,305 | $6,719 | $34,707 | $47,731 |
Comprehensive Loss
Comprehensive loss is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources. Net changes in unrealized gains and losses on available-for-sale securities are included in other comprehensive loss and represent the difference between our net loss and comprehensive loss for all periods presented.
Net 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 the three and nine months ended September 30, 2026 and 2025, 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):
| As of September 30, | ||
|---|---|---|
| 2026 | 2025 | |
| Stock options outstanding | 28,025 | 28,888 |
| Restricted stock units outstanding | 9,852 | 4,014 |
| Warrants outstanding | 298 | 298 |
| Series A Preferred Stock convertible to common shares | 700 | 5,241 |
| Shares of common stock underlying convertible notes outstanding | 19,444 | 19,444 |
Segment Reporting
Management, upon consideration of the organizational structure of the business and information reviewed by our Chief Executive Officer, who is also our chief operating decision maker ("CODM"), has concluded that we haveone reportable segment. All revenues for the three and nine months ended September 30, 2026 and 2025 were generated from customers in the U.S. The CODM allocates resources and evaluates the performanceof the reportable segment, which is the consolidated entity, primarily based on net lossas reported on the consolidated statements of operations and comprehensive loss. The significant expenses reviewed by the CODM are cost of product sales, research and development expenses, general and administrative expenses, and sales and marketing expenses as reported on the consolidated statements of operations and comprehensive loss. The Company's operating segments do not record intercompany revenue or allocate any expenses. The CODM does not evaluate operating segments using discrete asset information.
Recently Issued Accounting Standards Not Yet Adopted
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 not believe any will have a material impact on our condensed consolidated financial statements or related financial statement disclosures.
In November 2024, the FASB issued ASU 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses("ASU 2024-03"), which requires disaggregated disclosures of certain categories of expenses that are included in the face of the financial statements. This standard is effective for fiscal years beginning after December 15, 2026 and interim periods beginning after December 15, 2027. Early adoption is permitted. We are currently evaluating the impact on our disclosures.
In December 2025, the FASB issued ASU 2025-11, Interim Reporting (Topic 270): Narrow-Scope Improvements, which provides clarity regarding the existing required interim GAAP disclosures. This standard is effective for interim reporting periods within annual reporting periods beginning after December 15, 2027. Early adoption is permitted. We are currently evaluating the impact on our disclosures.
- 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 atSeptember 30,2026 | Quoted Pricesin ActiveMarkets forIdenticalAssets(Level 1) | SignificantOtherObservableInputs(Level 2) | SignificantUnobservableInputs(Level 3) | |
| Cash and money market funds | $11,595 | $11,595 | $— | $— |
| U.S. treasury bills and government agency obligations | 5,963 | 5,963 | — | — |
| U.S. corporate debt securities | 2,502 | — | 2,502 | — |
| U.S. commercial paper | 1,696 | — | 1,696 | — |
| Foreign commercial paper | 893 | — | 893 | — |
| Foreign corporate debt securities | 800 | — | 800 | — |
| Total | $23,449 | $17,558 | $5,891 | $— |
| Fair Value Measurements at Reporting Date Using | ||||
|---|---|---|---|---|
| Balance atDecember 31,2025 | Quoted Pricesin ActiveMarkets forIdenticalAssets(Level 1) | SignificantOtherObservableInputs(Level 2) | SignificantUnobservableInputs(Level 3) | |
| Cash and money market funds | $22,313 | $22,313 | $— | $— |
| U.S. treasury bills and government agency obligations | 9,534 | 9,534 | — | — |
| U.S. corporate debt securities | 7,035 | — | 7,035 | — |
| U.S. commercial paper | 1,545 | — | 1,545 | — |
| Foreign commercial paper | 3,979 | — | 3,979 | — |
| Foreign corporate debt securities | 2,225 | — | 2,225 | — |
| Total | $46,631 | $31,847 | $14,784 | $— |
We havenot transferred any investment securities between the three levels of the fair value hierarchy for the three and nine months ended September 30, 2026 and 2025.
As of September 30, 2026, cash equivalents included $3.6 million of available-for-sale securities with contractual maturities of three months or less and short-term investments included $1.7 million of available-for-sale securities with contractual maturities of three months to one year. As of December 31, 2025, cash equivalents included $11.6 million of available-for-sale securities with contractual maturities of three months or less and short-term investments included $5.4 million of available-for-sale securities with contractual maturities of three months to one year. The money market funds as of September 30, 2026 and December 31, 2025 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 September 30, 2026 and December 31, 2025 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, as the terms were based on market conditions.
- Short-Term Investments
The following is a summary of our short-term investments (in thousands):
| Gross · Gross | ||||
|---|---|---|---|---|
| Amortized | Unrealized | Unrealized | Estimated | |
| Cost | Gains | Losses | Fair Value | |
| U.S. treasury bills and government agency obligations | $5,966 | $— | $(3) | $5,963 |
| U.S. corporate debt securities | 2,505 | — | (3) | 2,502 |
| U.S. commercial paper | 1,697 | — | (1) | 1,696 |
| Foreign commercial paper | 893 | — | — | 893 |
| Foreign corporate debt securities | 800 | — | — | 800 |
| Total | $11,861 | $— | $(7) | $11,854 |
| Gross · Gross | ||||
|---|---|---|---|---|
| Amortized | Unrealized | Unrealized | Estimated | |
| Cost | Gains | Losses | Fair Value | |
| U.S. treasury bills and government agency obligations | $5,542 | $2 | $— | $5,544 |
| U.S. corporate debt securities | 5,439 | 1 | — | 5,440 |
| U.S. commercial paper | 1,545 | — | — | 1,545 |
| Foreign commercial paper | 3,979 | — | — | 3,979 |
| Foreign corporate debt securities | 1,475 | 1 | — | 1,476 |
| Total | $17,980 | $4 | $— | $17,984 |
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 didnot recognize any impairment losses during thethree and nine months ended September 30, 2026 and 2025.
Unrealized gains and losses associated with our investments are reported in accumulated other comprehensive loss. Realized gains and losses associated with our investments, if any, are reported in the statements of operations and comprehensive loss. We didnot recognize any realized gains or losses during thethree and nine months ended September 30, 2026 and 2025.
- Inventory
Inventory consists of the following (in thousands):
| September 30, 2026 | December 31, 2025 | |
|---|---|---|
| Raw materials | $57,300 | $59,250 |
| Work in process | 19,322 | 26,613 |
| Finished goods | 14,679 | 6,883 |
| Total inventory | $91,301 | $92,746 |
| September 30, 2026 | December 31, 2025 | |
|---|---|---|
| CINVANTI | $22,815 | $27,417 |
| SUSTOL | 383 | 1,307 |
| ZYNRELEF | 60,385 | 60,436 |
| APONVIE | 7,718 | 3,586 |
| Total inventory | $91,301 | $92,746 |
For the three and nine months ended September 30, 2026, cost of product sales included charges of $0.5 million and $1.7 million, respectively, relating to reserves and write-offs of inventory. For thethree and nine months ended September 30, 2025, cost of product sales included charges of $2.2 million and $2.7 million, respectively, relating to reserves and write-offs of inventory.
- Commitments and Contingencies
Litigation and Other Contingencies
The Company is, from time to time, subject to a variety of litigation and other proceedings incidental to its business, including lawsuits involving claims relating to intellectual property matters, employment matters, commercial disputes, as well as regulatory investigations or enforcement. The Company may also become subject to lawsuits as a result of past or future acquisitions, or as a result of liabilities retained from, or representations, warranties or indemnities provided in connection with divested businesses. Some of these lawsuits may include claims for punitive and consequential as well as compensatory damages. The outcomes of the Company's legal proceedings and other contingencies are inherently unpredictable and subject to significant uncertainties. We have not reserved any amounts for contingencies related to such litigation because they are neither probable nor reasonably estimable based on information currently available. See "Part II. Item 1. Legal Proceedings" in this Quarterly Report on Form 10-Q for further discussion of pending legal proceedings. There can be no assurance that there will not be a change in the scope of one or more of these matters or that any other future legal matters will or will not be material to the Company's financial position, results of operations or cash flows for a particular period.
Leases
In August 2025, we entered into an operating lease agreement for 16,837 square feet of office space in Cary, North Carolina. The lease commenced on May 1, 2026, and will expire 111 months from the lease commencement date, with theoption to extend for one additional period of 84 months upon written notice. We recorded a right-of-use lease asset and lease liability of $5.7 million upon lease commencement. We provided the landlord with a letter of credit for $0.2 million, which is included within cash and cash equivalents in the condensed consolidated balance sheet.
In December 2025, we entered into a short-term operating lease agreement for 9,882 square feet of office space in Cary, North Carolina, with a lease term that expired on February 28, 2026.
During the three and nine months ended September 30, 2026, we recognized $0.2 million and $0.3 million of operating lease expense, respectively. During thethree months ended September 30, 2026, we didnot incur any cash payments for our operating leases. During thenine months ended September 30, 2026, we paid $0.1 million for our operating leases.
During the three and nine months ended September 30, 2025, we recognized $0.8 million and $2.3 million of operating lease expense. During thethree and nine months ended September 30, 2025, we paid $0.8 million and $2.4 million for our operating leases, respectively.
Annual future minimum lease payments as of September 30, 2026 are as follows (in thousands):
| 2026 | $— |
| 2027 | 576 |
| 2028 | 646 |
| 2029 | 665 |
| 2030 | 685 |
| Thereafter | 3,412 |
| Total future minimum lease payments | 5,984 |
| Less: discount | 266 |
| Total lease liabilities | $5,718 |
- Long-Term Debt and Convertible Notes
Working Capital Facility Agreement
On August 9, 2023, we entered into a working capital facility agreement (the "Initial Working Capital Facility Agreement") with Hercules Capital, Inc., as administrative agent, collateral agent, and lender ("Hercules"). The Initial Working Capital Facility Agreement provided for an aggregate principal amount of up to $50.0 million with tranched availability as follows: (i) $25.0 million at closing on August 9, 2023 ("tranche 1A"), (ii) $5.0 million available through December 15, 2024 ("tranche 1B") and (iii) $20.0 million available from the earlier of: (a) the full draw of tranche 1B and (b) 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 Initial Working Capital Facility Agreement had a term offour years, with a springing maturity date that was 91 days prior to the stated maturity of our 2026 Convertible Notes (as defined below), if still outstanding at such time. The loans thereunder did not have any scheduled amortization payments and accrued 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, any loans under the Initial Working Capital Facility Agreement also accrued paid-in-kind interest at a fixed rate of 1.5% per annum which was due upon maturity or payoff.
In addition, in connection with the tranche 1A funding, we issued warrants to Hercules to purchase up to 297,619 shares of our common stock at an exercise price of $1.68 per share (the "Hercules Warrants"). The Hercules Warrants are equal to 2.00% of the principal amount of the tranche 1A loans funded by Hercules (the "Warrant Coverage"). The Initial Working Capital Facility Agreement also required that we issue additional warrants to Hercules at the time of each draw down of tranches 1B and 1C with the same Warrant Coverage. Each Hercules Warrant is exercisable for seven years from the date of issuance. The Hercules Warrant issued in conjunction with the tranche 1A funding remains outstanding at September 30, 2026.
On February 13, 2025, we entered into an amendment to the Initial Working Capital Facility Agreement (the "First Amendment to the Working Capital Facility Agreement") to extend the maturity date to the earlier of (a)September 1, 2027 and (b) to the extent that any of the 2026 Convertible Notes remain outstanding on such date, (i)May 12, 2026 or (ii) in the event that the maturity date of any 2026 Convertible Notes is extended, prior to May 12, 2026, to August 11, 2026, or later, the date that is 91 days prior to the maturity date of such further extended 2026 Convertible Notes.
On August 8, 2025, we entered into an amendment to the Initial Working Capital Facility Agreement, as amended by the First Amendment to the Working Capital Facility Agreement (the "Second Amendment to the Working Capital Facility Agreement'). The Second Amendment to the Working Capital Facility Agreement (i) provides for an aggregate principal amount of up to $150.0 million plus the accrued and unpaid paid-in-kind interest on the existing debt under the Initial Working Capital Facility Agreement at closing on August 12, 2025, (ii) extends the maturity date under the First Amendment to the Working Capital Facility Agreement to September 1, 2030, (iii) adjusts the interest rate to Prime, with a 7.5% floor, plus 1.95%, (iv) adjusts the paid-in-kind interest rate to 1.0% per annum, which is due upon maturity or payoff, and (v) provides for payment of a 1.0% upfront facility charge and an end of term charge of up to 6.25% of principal drawn. The loans under the Second Amendment to the Working Capital Facility Agreement do not have any scheduled amortization payments. The approximately $150.0 million aggregate principal has tranched availability as follows: (i) $110.0 million plus capitalized paid-in-kind interest of approximately $0.8 million on August 12, 2025 ("tranche 1"), (ii) $20.0 million available through December 15, 2026 ("tranche 2") and (iii) $20.0 million available from the earlier of: (a) the full draw of tranche 2 and (b) September 30, 2027 ("tranche 3"), and in the case of tranches 2 and 3, subject to certain customary conditions to draw down.
The Second Amendment to the Working Capital Facility Agreement contains a minimum cash covenant, a minimum revenue covenant and a minimum EBITDA covenant. In the event of a default under the Working Capital Facility Agreement or any future debt agreement, our lenders could declare all outstanding principal, together with accrued and unpaid interest, to be immediately due and payable. The Second Amendment to the Working Capital Facility Agreement 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.
On January 30, 2026, we entered into an amendment to the Initial Working Capital Facility Agreement, as amended by the First Amendment to the Working Capital Facility Agreement and the Second Amendment to the Working Capital Facility Agreement (the "Third Amendment to Working Capital Facility Agreement") to increase the end of term charge to be up to 6.50%, depending on the end of term.
On August 7, 2026, we entered into a Waiver, Consent and Fourth Amendment to the Working Capital Facility Agreement (the "Fourth Amendment to the Working Capital Facility Agreement") to the Initial Working Capital Facility Agreement, as amended by the First Amendment to the Working Capital Facility Agreement, the Second Amendment to the Working Capital Facility Agreement and the Third Amendment to the Working Capital Facility Agreement. The Fourth Amendment to the Working Capital Facility Agreement, among other things, (a) waives the minimum revenue and minimum EBITDA financial covenants for the fiscal quarter ended June 30, 2026 and (b) amends the Working Capital Facility Agreement to (i) require a prepayment by the Company of $17,500,000 in principal amount outstanding under the Working Capital Facility Agreement (the "Prepayment"), consisting of a $13,500,000 prepayment made upon effectiveness of the Fourth Amendment to the Working Capital Facility Agreement and a second prepayment of up to $4,000,000 due on or before September 15, 2026 (which second prepayment may be reduced, including to zero, if certain conditions set forth therein are met), together with End of Term Fees of $661,500 and up to $196,000, respectively, plus accrued PIK Interest (as defined under the Fourth Amendment to the Working Capital Facility Agreement) due on such Prepayment with any fees associated with the Prepayment to be waived, (ii) eliminate the future availability of $20.0 million through December 15, 2026 ("tranche 2") and $20.0 million through September 30, 2027 ("tranche 3"), (iii) revise the minimum revenue covenant, the minimum EBITDA covenant and the minimum cash covenant effective as of the reporting period ending August 31, 2026, (iv) permit the Company to enter into an agreement for certain products, subject to the lenders' approval of the final terms, and (v) include certain other covenants regarding other potential strategic transactions.
On September 17, 2026, we entered into the Fifth Amendment to the Working Capital Facility Agreement (the "Fifth Amendment to the Working Capital Facility Agreement") to the Initial Working Capital Facility Agreement, as amended by the First Amendment to the Working Capital Facility Agreement, the Second Amendment to the Working Capital Facility Agreement, the Third Amendment to the Working Capital Facility Agreement, and the Fourth Amendment to the Working Capital Facility Agreement. The Fifth Amendment to the Working Capital Facility Agreement, among other things, amended the terms of the
September 15, 2026 payment of $4,000,000 as specified in the Fourth Amendment to the Working Capital Facility Agreement to separate the payment into a $1,000,000 payment payable on September 15, 2026 and a $3,000,000 payment payable on September 30, 2026. We completed these prepayments, together with End of Term Fees of $49,000 and $147,000, respectively, plus accrued PIK Interest due on such Prepayment with any fees associated with the Prepayment to be waived.
The Initial Working Capital Facility Agreement, together with the First Amendment to the Working Capital Facility Agreement, the Second Amendment to the Working Capital Facility Agreement, the Third Amendment to the Working Capital Facility Agreement, the Fourth Amendment to the Working Capital Facility Agreement and the Fifth Amendment to the Working Capital Facility Agreement is referred to collectively as the "Working Capital Facility Agreement".
Pursuant to the terms of the Asset Purchase Agreement, all outstanding amounts under the Working Capital Facility Agreement will be repaid upon the closing of the Asset Sale.
The Second Amendment to the Working Capital Facility Agreement was accounted for in accordance with ASC Topic 470, Debt. Amendments are assessed by management to determine appropriate treatment as troubled debt restructurings, extinguishments or modifications. The Second Amendment to the Working Capital Facility Agreement qualifies as a debt extinguishment and issuance of a new debt instrument. We recorded a loss on extinguishment during the quarter ended September 30, 2025, of $5.5 million, equal to the carrying value of the Second Amendment to the Working Capital Facility Agreement less the carrying value of the First Amendment to the Working Capital Facility Agreement on August 12, 2025 of $0.3 million, the facility charge of $1.1 million paid to the lenders, the remaining Initial Working Capital Facility Agreement end of term fee of $0.2 million and the present value of Second Amendment to the Working Capital Facility Agreement end of term fee of $3.9 million. The Initial Working Capital Facility Agreement end of term fee is payable on September 1, 2027. The remaining Second Amendment to the Working Capital Facility Agreement end of term fee will be accreted to interest expense over the term of the agreement using the effective interest rate method.
The Third Amendment to the Working Capital Facility Agreement, the Fourth Amendment to the Working Capital Facility Agreement and the Fifth Amendment to the Working Capital Facility Agreement were accounted for in accordance with ASC Topic 470, Debt. Amendments are assessed by management to determine appropriate treatment as troubled debt restructurings, extinguishments or modifications. The Third Amendment to the Working Capital Facility Agreement, the Fourth Amendment to the Working Capital Facility Agreement and the Fifth Amendment to the Working Capital Facility Agreement each qualified as a modification.
The tranche 1 funding under the Second Amendment to the Working Capital Facility Agreement is accounted for as debt and was recorded as a liability on the condensed consolidated balance sheets. In addition, the additional borrowings available under the Second Amendment to the Working Capital Facility Agreement are accounted for as a single freestanding financial instrument that are not assets or obligations of ours and will be accounted for when and if we borrow additional tranches in the future.
In connection with the Second Amendment to the Working Capital Facility Agreement, we incurred debt issuance costs of $3.5 million, which were recorded as a debt discount. The debt discount is being amortized into interest expense using the effective interest rate method over the term of the Second Amendment to the Working Capital Facility Agreement. The effective interest rate as of September 30, 2026 is 11.8%.
For the three months ended September 30, 2026, interest expense related to the Working Capital Facility Agreement was $3.0 million, which included $2.5 million related to the stated interest rate, $0.3 million related to paid-in-kind interest, and $0.2 million related to the amortization of the debt discounts and accretion of the end of term fee.
For the nine months ended September 30, 2026, interest expense related to the Working Capital Facility Agreement was $9.4 million, which included $7.8 million related to the stated interest rate, $0.8 million related to paid-in-kind interest, and $0.8 million related to the amortization of the debt discounts and accretion of the end of term fee.
For the three months ended September 30, 2025, interest expense related to the Working Capital Facility Agreement was $2.2 million, which included $1.7 million related to the stated interest rate, $0.2 million related to paid-in-kind interest, and $0.2 million related to the amortization of the debt discounts and accretion of the end of term fee.
For the nine months ended September 30, 2025, interest expense related to the Working Capital Facility Agreement was $4.0 million , which included $3.0 million related to the stated interest rate, $0.4 million related to paid-in-kind interest, and $0.6 million related to the amortization of the debt discounts and accretion of the end of term fee.
As of September 30, 2026, the carrying value of the Working Capital Facility Agreement was $91.6 million, which is comprised of the $93.3 million principal amount outstanding, $1.3 million of accumulated paid-in-kind interest, less debt discounts of $3.0 million. The end of term fee accreted as of September 30, 2026, of $4.3 million is recorded in other non-current liabilities on the condensed consolidated balance sheets.
2026 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 aggregate principal amount of senior unsecured convertible notes due 2026 (the "2026 Convertible Notes").
On August 8, 2025, we entered into an exchange agreement pursuant to which $150.0 million aggregate principal amount of the 2026 Convertible Notes outstanding were exchanged for (i)16,666,666 shares of common stock for an aggregate principal amount of $25.0 million of the 2026 Convertible Notes and (ii) the remaining $125.0 million plus accrued and unpaid interest under the 2026 Convertible Notes paid in cash, and which closed on August 12, 2025. As of September 30, 2026, no 2026 Convertible Notes remain outstanding.
For the three months ended September 30, 2025, interest expense related to the 2026 Convertible Notes was $0.4 million, which included $0.4 million related to the stated interest rate and nil related to the amortization of debt issuance costs.
For the nine months ended September 30, 2025, interest expense related to the 2026 Convertible Notes was $1.6 million, which included $1.5 million related to the stated interest rate and $0.1 million related to the amortization of debt issuance costs.
2031 Senior Unsecured Convertible Notes
On August 8, 2025, we entered into the 2031 Convertible Notes Purchase Agreement with a fund affiliated with Rubric Capital Management LP ("Rubric") for a private placement of $35.0 million aggregate principal amount of senior unsecured convertible notes due 2031 (the "2031 Convertible Notes"), which closed on August 12, 2025. We received a total of $31.9 million, net of issuance costs and original issuance discount, from the issuance of the 2031 Convertible Notes.
The 2031 Convertible Notes were issued at par. The 2031 Convertible Notes bear interest at a rate of 5.0% per annum, payable in cash semi-annually in arrears on March 1 and September 1 of each year, or at a rate of 7.0% per annum for paid-in-kind interest prior to September 1, 2026. The 2031 Convertible Notes mature on March 1, 2031, unless earlier converted, redeemed or repurchased.
The 2031 Convertible Notes are subject to redemption at our option, after September 1, 2026, but only 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 2031 Convertible Notes to be redeemed, plus accrued and unpaid interest.
The 2031 Convertible Notes can be settled in either shares of common stock, cash or a combination of cash and shares of common stock based on the conversion rate in effect on the date of conversion. The initial conversion rate for the 2031 Convertible Notes is 555.5556 shares per $1,000 principal amount of the 2031 Convertible Notes (equivalent to an initial conversion price of $1.80 per share of common stock), subject to certain adjustments.
If a holder of the 2031 Convertible 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.
The 19,444,444 shares of common stock issuable upon the conversion, at the option of the holder, of the 2031 Convertible Notes, are registered for resale pursuant to a registration statement filed with and declared effective by the SEC in September 2025.
At a special meeting of stockholders held on October 13, 2025, the Company's stockholders approved, pursuant to Nasdaq Listing Rule 5635(d), the issuance of shares of common stock in connection with the conversion of the 2031 Convertible Notes, which could, under certain circumstances that may occur in the future, exceed 19.99% of the number of shares of the common stock issued and outstanding prior to such issuance. Pursuant to the terms of an Exchange Agreement, dated November 8, 2026, by and between the Company and Rubric (the "Exchange Agreement"), beginning with the Company's fiscal quarter ending March 31, 2027, within 30 calendar days of the last day of such fiscal quarter (each such last day, an "Applicable Date"), Rubric may deliver written notice requesting the exchange of all or a portion of the outstanding 2031 Convertible Notes for unregistered shares of CorMedix's common stock, par value $0.001 pershare ("CorMedix common stock") to be received by the Company as stock consideration in connection withthe Asset Sale, subject to minimum quarterly amounts of $10.0 million in principal amount for each of the first three quarters and $5.0 million in principal amount, plus any accrued and unpaid interest, for the final quarter. Any amounts not requested to be exchanged in a quarter will be allocated pro rata to the remaining quarters. Any exchange of up to $10.0 million per quarter will be subject to the Minimum Exchange Price (as defined in the Exchange Agreement), such that no outstanding 2031 Convertible Notes will be required to be exchanged if the Exchange Price (as defined below) does not exceed the Minimum Exchange Price. Any exchange in excess of $10.0 million per quarter will be subject to the mutual written agreement of the Company and Rubric. The outstanding 2031 Convertible Notes will be exchanged solely for unregistered shares of CorMedix common stock to be received by the Company as stock consideration in connection with the Asset Sale, valued based on the volume-weighted average price of CorMedix common stock over the five consecutive trading days prior to the Applicable Date (the "Exchange Price"). Following each exchange, Rubric will deliver a payoff letter with respect to the exchanged portion of the 2031 Convertible Notes. The Exchange Agreement will terminate upon the mutual written consent of the parties, termination of the Asset Purchase Agreement in accordance with its terms, or the full satisfaction and discharge of all outstanding 2031 Convertible Notes.
The 2031 Convertible Notes were accounted for in accordance with ASC 470-20 and 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 2031 Convertible 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 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 2031 Convertible Notes were recorded as a liability on the condensed consolidated balance sheets.
We incurred issuance costs related to the 2031 Convertible Notes of $1.4 million, which we recorded as debt issuance costs and are included as a reduction to the 2031 Convertible Notes on the condensed consolidated balance sheets. We also incurred an original issuance discount of $1.75 million, which we recorded as a reduction to the 2031 Convertible Notes on the condensed consolidated balance sheets. The debt issuance costs and original issuance discount are being amortized to interest expense using the effective interest rate method over the term of the 2031 Convertible Notes, resulting in an effective interest rate of 7.14%.
For the three months ended September 30, 2026, interest expense related to the 2031 Convertible Notes was $0.6 million, which included $0.2 million related to the stated interest rate, $0.4 million related to paid-in-kind interest and $0.03 million related to the amortization of debt discount and debt issuance costs.
For the nine months ended September 30, 2026, interest expense related to the 2031 Convertible Notes was $1.8 million, which included $0.2 million related to the stated interest rate, $1.7 million related to paid-in-kind interest and $0.04 million related to the accretion of debt issuance costs and debt discounts.
For the three and nine months ended September 30, 2025, interest expense related to the 2031 Convertible Notes was $0.3 million, respectively, which included $0.3 million, related to paid-in-kind interest andnil, related to the amortization of debt issuance costs.
As of September 30, 2026, the carrying value of the 2031 Convertible Notes was $34.4 million, which is comprised of the $35.0 million principal amount of the 2031 Convertible Notes outstanding, $2.6 million of accumulated paid-in-kind interest, less debt issuance costs of $3.2 million.
- Private Placement Equity Offering
On August 8, 2025, we entered into a securities purchase agreement with the purchasers, for a private placement of (i)13,225,227 shares of common stock at a purchase price of $1.50 per share and (ii)524,141 shares of Series A convertible preferred stock, which would automatically convert upon stockholder approval into 5,241,410 shares of common stock, at a conversion price of $1.50 per share (stated value of $15.00 per share) for aggregate gross proceeds of $27.7 million, and which closed on August 12, 2025. In connection with the private placement equity offering, we incurred issuance costs of $1.5 million. The Series A convertible preferred stock is convertible to common stock at a ratio often shares of common stock for each share of Series A convertible preferred stock and has a par value of $0.01. The Series A convertible preferred stock ranks senior to common stock with respect to dividend rights and rights on the distribution of assets in an event of liquidation. The Series A convertible preferred stockholders have no voting rights and are entitled to receive dividends on an as converted basis in the same form as dividends granted to holders of common stock. Upon a liquidation, the proceeds available for distribution would be paid pari passu among the holders of shares of common stock and Series A convertible preferred stock, pro rata based on the number of shares held by each such holder and on an as converted basis.
The 13,225,227 shares of common stock and 5,241,410 shares of common stock issuable upon automatic conversion of the Series A convertible preferred stock are registered for resale pursuant to a registration statement filed with and declared effective by the SEC in September 2025.
At a special meeting of stockholders held on October 13, 2025, the Company's stockholders approved, pursuant to Nasdaq Listing Rule 5635(d), the issuance of shares of common stock in connection with the conversion of the Series A convertible preferred stock, which could, under certain circumstances that may occur in the future, exceed 19.99% of the number of shares of the common stock issued and outstanding prior to such issuance.
Upon stockholder approval in October 2025,454,129 shares of Series A convertible preferred stock were converted to common stock, resulting in the issuance of 4,541,290 shares of common stock. The remaining 70,012 shares of Series A convertible preferred stock are subject to beneficial ownership limitations and thus did not convert to common stock as of September 30, 2026.
- Equity Incentive Plan
Option Plan Activity
The following table summarizes the stock option activity for thenine months ended September 30, 2026:
| Shares(in thousands) | Weighted-AverageExercise Price | Weighted-AverageRemainingContractualTerm (Years) | |
|---|---|---|---|
| Outstanding at December 31, 2025 | 28,705 | $2.98 | 7.64 |
| Granted | 366 | $0.99 | |
| Exercised | — | $— | |
| Expired and forfeited | (1,046) | $6.09 | |
| Outstanding at September 30, 2026 | 28,025 | $2.84 | 6.97 |
We estimated the fair value of each option grant on the grant date using the Black-Scholes option pricing model. The following are the weighted-average assumptions:
| For the Nine Months Ended September 30, | ||
|---|---|---|
| 2026 | 2025 | |
| Risk-free interest rate | 3.9% | 4.2% |
| Dividend yield | 0.0% | 0.0% |
| Volatility | 79.9% | 80.1% |
| Expected life (years) | 6 to 10 | 6 to 10 |
The following table summarizes the restricted stock unit ("RSUs") activity for thenine months ended September 30, 2026:
| Shares(in thousands) | Weighted-Average Grant Date Fair Value | |
|---|---|---|
| Outstanding at December 31, 2025 | 3,799 | $1.91 |
| Granted | 8,051 | $1.31 |
| Released | (1,679) | $1.67 |
| Expired and forfeited | (319) | $1.38 |
| Outstanding at September 30, 2026 | 9,852 | $1.48 |
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 afour-year period.
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 Nine Months Ended September 30, | ||
|---|---|---|
| 2026 | 2025 | |
| Risk-free interest rate | 3.8% | 4.2% |
| Dividend yield | 0.0% | 0.0% |
| Volatility | 67.7% | 79.1% |
| Expected life (months) | 6 | 6 |
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 EndedSeptember 30, | Nine Months EndedSeptember 30, | |||
|---|---|---|---|---|
| 2026 | 2025 | 2026 | 2025 | |
| Research and development | $257 | $277 | $789 | $797 |
| General and administrative | 1,968 | 1,918 | 5,800 | 5,315 |
| Sales and marketing | 858 | 657 | 2,648 | 2,048 |
| Total stock-based compensation expense | $3,083 | $2,852 | $9,237 | $8,160 |
As of September 30, 2026, there was$22.8 millionof 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 oftwo years.
- 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 September 30, 2026.
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 2025 Annual Report, continue to be accurate for the three and nine months ended September 30, 2026.
- Subsequent Events
Proposed Asset Sale
On November 8, 2026, the Company entered into an Asset Purchase Agreement (the "Asset Purchase Agreement") with CorMedix, pursuant to which it has agreed to sell substantially all of its assets to CorMedix, other than certain excluded assets, including its federal income tax net operating loss carryforwards (the "NOLs") and certain other tax attributes, and CorMedix has agreed to acquire those assets and assume certain liabilities of the Company as set forth in the Asset Purchase Agreement (the "Asset Sale"). As consideration for the Asset Sale, CorMedix has agreed to (i) issue to the Company 14,583,333 shares of CorMedix common stock, (ii) pay to the Company a purchase price equal to $145.0 million in cash, subject to certain adjustments for the Company’s closing cash and net working capital as set forth in the Asset Purchase Agreement, of which $2.0 million will be deposited into escrow, at the closing of the Asset Sale to secure post-closing adjustments to the cash consideration, which post-closing adjustments may not exceed $10.0 million in either direction, (iii) pay to the Company royalties equal to 5.0% of the amount, if any, by which aggregate annual net sales of CINVANTI, SUSTOL and the products covered by the Company's multi-product Development and License Agreement (the "License Agreement") with Long Grove Pharmaceuticals, LLC, a Delaware limited liability company ("Long Grove"), exceed $25.0 million in each of calendar years 2027, 2028 and 2029, if and when payable, on the terms set forth in the Asset Purchase Agreement, (iv) pay to the Company earn-out payments of $25.0 million if net sales of ZYNRELEF for calendar year 2028 equal or exceed $65.0 million and an additional $30.0 million if such net sales equal or exceed $95.0 million, payable at CorMedix's election in cash, shares of CorMedix common stock or a combination thereof (provided that any portion that would cause the aggregate shares of CorMedix common stock issued under the Asset Purchase Agreement to exceed 19.9% of the CorMedix common stock outstanding as of the closing of the Asset Sale will be paid in cash), if and when payable, on the terms set forth in the Asset Purchase Agreement and (v) assume certain of the Company’s liabilities as specified in the Asset Purchase Agreement.
The Asset Sale, which has been unanimously approved by the board of directors of the Company (the "Board"), is currently expected to close in the first quarter of 2027, subject to approval by the Company's stockholders and the satisfaction of other customary closing conditions. The Asset Purchase Agreement contains certain termination rights in favor of each of the Company and CorMedix. In addition, the Asset Purchase Agreement provides that, in connection with certain terminations of the Asset Purchase Agreement, depending on the circumstances surrounding the termination, one party may be required to pay the other party a termination fee of $4.0 million.
If the Asset Sale closes, the Company will exit the operation of its current biotechnology business and other historical operations, but it does not intend to liquidate and will remain a publicly traded company. The Company will retain other material assets following the closing of the Asset Sale, including the shares of CorMedix common stock issued to the Company in the Asset Sale, the right to receive future royalties, earn-out payments, significant NOLs and cash on hand. Following the closing of the Asset Sale, the Board intends to actively evaluate various strategic transactions and opportunities for the use of the proceeds of the Asset Sale, including acquiring or investing in additional businesses or assets, which may or may not be pharmaceutical or biotechnology businesses or assets. Such opportunities may include, but are not limited to, the acquisition of products, product candidates, milestone payments and royalty streams, programs or technologies as well as pursuing strategic alliances, joint ventures, investments in complementary businesses, out-licensing and in-licensing agreements, divestitures or other transactions. It is currently uncertain what businesses or assets the Company may acquire or invest in following the closing of the Asset Sale, and the Board intends to evaluate opportunities to create value for the benefit of stockholders.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.