EyePoint, Inc.
For the period ended Dec 31, 2025. Filed Mar 5, 2026.
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FY2025 · Filed Mar 5, 2026
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Notes to Consolidated Financial Statements
Operations
EyePoint, Inc., a Delaware corporation (together with its subsidiaries, the Company), is a clinical-stage biopharmaceutical company committed to developing and commercializing innovative therapeutics to help improve the lives of patients with serious retinal diseases. The Company's pipeline leverages its proprietary bioerodible Durasert E™ technology (Durasert E™) for sustained intraocular drug delivery. The Company’s lead product candidate, DURAVYU™, is an investigational sustained delivery treatment for vascular endothelial growth factor (VEGF) mediated retinal diseases combining vorolanib, a selective and patent-protected tyrosine kinase inhibitor (TKI) with Durasert E™. DURAVYU is currently being evaluated in Phase 3 pivotal trials (LUGANO and LUCIA) for wet age-related macular degeneration (wet AMD) with data readout beginning in mid-2026. Pivotal Phase 3 clinical trials (COMO and CAPRI) in diabetic macular edema (DME) are expected to dose patients in the first quarter of 2026. Additional pipeline programs include EYP-2301, razuprotafib, a TIE-2 agonist, formulated in Durasert E™ to potentially improve outcomes in serious retinal diseases. EyePoint is headquartered in Watertown, Massachusetts with a commercial manufacturing facility in Northbridge, Massachusetts.
The Company plans to identify and advance additional product candidates through clinical and regulatory development for its pipeline. This may be accomplished through internal discovery efforts, research collaborations and/or in-licensing arrangements and potential acquisitions of additional products, product candidates or technologies.
Liquidity
The Company had cash, cash equivalents and investments in marketable securities of $306.1 million at December 31, 2025. The Company has a history of operating losses and has not had significant recurring cash inflows from revenue. The Company’s operations have been financed primarily from sales of its equity securities, issuance of debt, and a combination of license fees, milestone payments, royalty income and other fees received from its collaboration partners. The Company anticipates that it will continue to incur losses as it continues the research and development of its product candidates, and the Company does not expect revenues from its product sales to generate sufficient funding to sustain its operations in the near-term. The Company expects to continue fulfilling its funding needs through cash inflows from revenues, licensing and research collaboration transactions, additional equity capital raises and other arrangements. The Company believes that its cash, cash equivalents and investments in marketable securities of $306.1 million at December 31, 2025, will enable the Company to fund its current and planned operations for at least the next twelve months from the date these consolidated financial statements were issued. Actual cash requirements could differ from management’s projections due to many factors, the timing and results of the Company’s clinical trials for DURAVYU, additional investments in research and development programs, competing technological and market developments, the costs of any ongoing obligations in connection with a final negotiated settlement with the DOJ and HHSand the costs of any strategic acquisitions, and/or development of complementary business opportunities.
Significant Accounting Policies
Basis of Presentation
The consolidated financial statements are presented in U.S. dollars in accordance with U.S. generally accepted accounting principles (U.S. GAAP) and include the accounts of EyePoint, Inc. and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated.
Use of Estimates
The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make certain estimates and assumptions that affect the reported amounts and disclosure of assets and liabilities at the date of the consolidated financial statements and the reported amounts and disclosure of revenues and expenses during the reporting periods. Significant management estimates and assumptions include, among others, those related to revenue recognition for multiple-deliverable arrangements, recognition of expense in outsourced clinical trial agreements, realization of deferred tax assets, and determining grant date fair value of stock options and other equity awards. Actual results could differ from these and other estimates and there may be changes to the Company’s estimates in future periods.
Foreign Currency
The functional currency of the Company and each of its subsidiaries is the currency of the primary economic environment in which each such entity operates—the U.S. dollar or the Pound Sterling.
Assets and liabilities of the Company’s foreign subsidiary are translated at period-end exchange rates. Amounts included in the consolidated statements of comprehensive loss and cash flows are translated at the weighted average exchange rates for the period. Gains and losses from currency translation are included in accumulated other comprehensive income as a separate component of stockholders’ equity on the consolidated balance sheets. Foreign currency gains or losses arising from transactions denominated in foreign currencies, whether realized or unrealized, are recorded in interest and other income, net in the consolidated statements of comprehensive loss and were not material for all periods presented.
Cash Equivalents
Cash equivalents represent highly liquid investments with maturities of three months or less at the date of purchase, principally consisting of institutional money market funds and investment-grade commercial paper and U.S. Treasury securities.
Marketable Securities
Marketable securities consist of investments with an original or remaining maturity of greater than three months but less than one year at the date of purchase. The Company has historically classified its marketable securities as available-for-sale. Accordingly, the Company records these investments at fair value, with unrealized gains and losses excluded from earnings and reported, net of tax, in accumulated other comprehensive income, which is a component of stockholders’ equity. If the Company determines that a decline of any investment is other-than-temporary, the investment is written down to fair value. Marketable securities consisted of investment-grade commercial paper, U.S. Treasury securities, and U.S. Agency securities at December 31, 2025 and 2024. The Company’s investment policy, approved by the Board of Directors, includes guidelines relative to diversification and maturities designed to preserve principal and liquidity.
The fair value of marketable securities is determined based on quoted market prices at the balance sheet date of the same or similar instruments. The amortized cost of debt securities is adjusted for amortization of premiums and accretion of discounts through to the earlier of sale or maturity. Such amortization and accretion amounts are included in interest and other income, net in the consolidated statements of comprehensive loss. The cost of marketable securities sold is determined by the specific identification method.
Concentrations of Credit Risk
Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash, cash equivalents, investments in marketable securities, and accounts receivable. The Company deposits its cash in financial institutions. At times, such deposits may be in excess of insured limits.
As of December 31, 2025, there were no accounts receivable balances. For the year ended December 31, 2025 revenues from ANI Pharmaceuticals, Inc. (ANI), formerly Alimera Sciences, Inc. and SWK Funding LLC (SWK), accounted for 54.8% and 40.4% of total revenues, respectively.
As of December 31, 2024, accounts receivable from ANI accounted for 72.3% and accounts receivable from OncoSil Medical Ltd. accounted for 16.5% of total accounts receivable, respectively. For the year ended December 31, 2024, revenues from ANI accounted for 93.6% of total revenues.
Fair Value Measurements
The Company accounts for certain assets and liabilities at fair value. The hierarchy below lists three levels of fair value based on the extent to which inputs used in measuring fair value are observable in the market. The Company categorizes each of its fair value measurements in one of these three levels based on the lowest level input that is significant to the fair value measurement in its entirety. These levels are:
Level 1 – Inputs are quoted prices (unadjusted) in active markets that are accessible at the measurement date for identical assets and liabilities.
Level 2 – Inputs are directly or indirectly observable in the marketplace, such as quoted prices for similar assets or liabilities in active markets or quoted prices for identical assets or liabilities with insufficient volume or infrequent transaction (less active markets).
Level 3 – Inputs are unobservable estimates that are supported by little or no market activity and require the Company to develop its own assumptions about how market participants would price the assets or liabilities.
The Company’s cash equivalents and marketable securities are classified within Level 1 or Level 2 on the basis of valuations using quoted market prices or alternative pricing sources and models utilizing market observable inputs, respectively. The marketable securities have been valued on the basis of valuations provided by third-party pricing services, as derived from such services’ pricing models. Inputs to the models may include, but are not limited to, reported trades, executable bid and ask prices, broker/dealer quotations, prices or yields of securities with similar characteristics, benchmark curves or information pertaining to the issuer, as well as industry and economic events. The pricing services may use a matrix approach, which considers information regarding securities with similar characteristics to determine the valuation for a security, and have been classified as Level 2.
The carrying amounts of accounts payable and accrued expenses approximate fair value because of their short-term maturity.
Inventory
Inventory is stated at the lower of cost or net realizable value, net on a first-in, first-out (FIFO) basis.
Capitalization of inventory costs begins after FDA approval of a product. Prior thereto, inventory costs of products and product candidates are recorded as research and development expense, even if this inventory may later be sold as commercial product.
The Company assesses the recoverability of inventory and writes down any excess and obsolete inventories to their estimated realizable value in the period in which the impairment is first identified. Write-downs are based on the age of the inventory, lower of cost or market, along with significant management judgments concerning future demands for the inventory. Such impairment charges, should they occur, are recorded within cost of sales. The determination of whether inventory costs will be realizable requires estimates by management. If actual market conditions are less favorable than management's projections, additional write-downs of inventory might be recorded in future periods.
Cost of sales consists of costs associated with the manufacture of YUTIQ®. The inventory costs for YUTIQ® include purchases of various components, the active pharmaceutical ingredient (API) and direct labor and overhead for the product manufactured in the Company’s Watertown, Massachusetts facility.
Debt and Equity Instruments
Debt and equity instruments are classified as either liabilities or equity in accordance with the substance of the contractual arrangement.
Property and Equipment
Property and equipment are recorded at cost and depreciated over their estimated useful lives (generally three tofive years) using the straight-line method. Leasehold improvements are amortized on a straight-line basis over the shorter of the remaining non-cancellable lease term or their estimated useful lives. Repair and maintenance costs are expensed as incurred. When assets are retired or sold, the assets and accumulated depreciation are derecognized from the respective accounts and any gain or loss is recognized.
Leases
The Company is a party totwo operating leases, the Company's headquarters in Watertown, Massachusetts, in which it leases office, laboratory, and manufacturing operations facilities and the Company's new standalone manufacturing facility, including office and lab space located at 600 Commerce Drive, Northbridge, Massachusetts (see Note 8).
The Company determines whether an arrangement is or contains a lease at inception. Leases are recognized on the consolidated balance sheets as ROU assets, current lease liabilities and noncurrent lease liabilities. ROU assets represent the Company’s right to use an underlying asset for the lease term, and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Lease liabilities and their corresponding ROU assets are recorded based on the present value of lease payments over the expected remaining lease term. For this purpose, the Company considers only payments that are fixed and in-substance fixed at lease commencement. ROU assets may also be adjusted for items such as prepayments and lease incentives. The interest rate implicit in a lease contract is typically not readily determinable. As a result, the Company utilizes its incremental borrowing rate, which is the rate incurred to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment. Lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. For operating leases, lease expense is recognized on a straight-line basis over the lease term. For finance leases, amortization expense and interest expense are recognized over the lease term.
Revenue Recognition
Revenue is recognized when a customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, Revenue from Contracts with Customers (ASC 606), the
Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within the contract, determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Sales, value-add and other taxes collected on behalf of third parties are excluded from revenue.
License and collaboration agreement revenue — The Company analyzes each element of its license and collaboration arrangements to determine the appropriate revenue recognition. The terms of the license agreement may include payment to the Company of non-refundable upfront license fees, milestone payments if specified objectives are achieved, and/or royalties on product sales. The Company recognizes revenue from upfront payments at a point in time, typically upon fulfilling the delivery of the associated intellectual property to the customer. For licenses that are combined with other promises, the Company determines whether the combined performance obligation is satisfied over time or at a point in time, when (or as) the associated performance obligation in the contract is satisfied.
If the contract contains a single performance obligation, the entire transaction price is allocated to the single performance obligation. Contracts that contain multiple performance obligations require an allocation of the transaction price based on the estimated relative standalone selling prices of the promised products or services underlying each performance obligation. The Company determines standalone selling prices based on the price at which the performance obligation is sold separately. If the standalone selling price is not observable through past transactions, the Company estimates the standalone selling price taking into account available information such as market conditions and internally approved pricing guidelines related to the performance obligations.
The Company recognizes sales-based milestone payments as revenue upon the achievement of the cumulative sales amount specified in the contract in accordance with ASC 606-10-55-65. For those milestone payments which are contingent on the occurrence of particular future events, the Company determines that these need to be considered for inclusion in the calculation of total consideration from the contract as a component of variable consideration using the most-likely amount method. As such, the Company assesses each milestone to determine the probability and substance behind achieving each milestone. Given the inherent uncertainty associated with these future events, the Company will not recognize revenue from such milestones until there is a high probability of occurrence, which typically occurs near or upon achievement of the event.
When determining the transaction price of a contract, an adjustment is made if payment from a customer occurs either significantly before or significantly after performance, resulting in a significant financing component. Applying the practical expedient in paragraph 606-10-32-18, the Company does not assess whether a significant financing component exists if the period between when the Company performs its obligations under the contract and when the customer pays is one year or less. None of the Company’s contracts contained a significant financing component as of December 31, 2025 and 2024, respectively, nor during the respective years then ended.
Royalties — The Company recognizes revenue from license arrangements with its commercial partners’ net sales of products. Such revenues are included as royalty income. In accordance with ASC 606-10-55-65, royalties are recognized when the subsequent sale of the commercial partner’s products occurs. The Company’s commercial partners are obligated to report their net product sales and the resulting royalty due to the Company typically within 60-days from the end of each quarter. Based on historical product sales, royalty receipts, and other relevant information, the Company recognizes royalty income each quarter and subsequently determines a true-up when it receives royalty reports and payment from its commercial partners. Historically, these true-up adjustments have been immaterial.
Sale of Future Royalties — The Company has sold its rights to receive certain royalties on product sales. In the circumstance where the Company has sold its rights to future royalties under a royalty purchase agreement (RPA) and also maintains limited continuing involvement in the arrangement (but not significant continuing involvement in the generation of the cash flows that are due to the purchaser), the Company defers recognition of the proceeds it receives for the sale of royalty streams and recognizes such unearned revenue as revenue under the units-of-revenue method over the life of the underlying license agreement. Under the units-of-revenue method, amortization for a reporting period is calculated by computing a ratio of the proceeds received from the purchaser to the total payments expected to be made to the purchaser over the term of the agreement, and then applying that ratio to the period’s cash payment.
Estimating the total payments expected to be received by the purchaser over the term of such arrangements requires management to use subjective estimates and assumptions. Changes to the Company’s estimate of the payments expected to be made to the purchaser over the term of such arrangements could have a material effect on the amount of revenues recognized in any particular period.
Research Collaborations— The Company recognizes revenue over the term of the statements of work under any funded research collaborations. Revenue recognition for consideration, if any, related to a license option right is assessed based on the terms of any such future license agreement or is otherwise recognized at the completion of the research collaborations.
Please refer to Note 3 for further details on the license and collaboration agreements into which the Company has entered and corresponding amounts of revenue recognized during the current and prior year periods.
Cost of sales— Cost of sales consist of costs associated with the manufacture of YUTIQ®.
Research and Development
Research and development costs are charged to operations as incurred. These costs include all direct costs, including cash and stock-based compensation and benefits for research, clinical development, quality assurance, quality control, operations and medical affairs personnel, third-party costs and services for clinical trials, clinical materials, pre-clinical programs, regulatory and medical affairs, external consultants, and other operational costs related to the Company’s research and development of its product candidates.
The Company records accruals for estimated ongoing research and development costs, including costs with respect to outsourced agreements for clinical trials with contract research organizations (CROs). When recording these prepaid and accrued expenses, the Company analyzes progress of the studies, including the phase or completion of events, invoices received, payments made, contracted costs, communications with third-party vendors, and internal tracking of the work performed to date. Judgments and estimates are made in determining the prepaid and accrued balances at the end of any reporting period. Payments made in advance of services provided are recorded as prepaid research and development costs and recognized as expense in the period the expense is incurred. In determining the prepaid and accrued balances, management makes its assessments of the services performed based on various factors, including reporting from third-party CROs and internal tracking of work performed during the period, which are subject to management’s judgment. Actual results could differ from the Company’s estimates.
Stock-Based Compensation
Compensation cost related to share-based payment awards is based on the fair value of the instrument on the grant date and is recognized on a graded vesting basis over the requisite service period for each separately vesting tranche of the awards. The Company classifies stock-based compensation expense in its consolidated statements of operations and comprehensive loss in the same manner in which the grantee’s payroll costs are classified or in which the grantee’s service payments are classified.
The Company may also grant share-based payment awards that are subject to objectively measurable performance and service criteria. Compensation expense for performance-based awards begins at such time as it becomes probable that the respective performance conditions will be achieved. The Company continues to recognize the grant date fair value of performance-based awards through the vesting date of the respective awards so long as it remains probable that the related performance conditions will be satisfied.
The Company estimates the fair value of stock option awards using the Black-Scholes option valuation model and the fair value of performance stock units, restricted stock units, and deferred stock units based on the observed grant date fair value of the underlying common stock.
Net Loss per Share
Basic net loss per share is computed by dividing the net loss by the weighted average number of common shares outstanding during the period. For periods in which the Company reports net income, diluted net income per share is determined by adding to the basic weighted average number of common shares outstanding the total number of dilutive common equivalent shares using the treasury stock method, unless the effect is anti-dilutive.
Comprehensive Loss
Comprehensive loss is comprised of net loss, foreign currency translation adjustments and unrealized gains and losses on available-for-sale marketable securities.
Income Tax
The Company accounts for income taxes under the asset and liability method. Deferred income tax assets and liabilities are computed for the expected future impact of differences between the financial reporting and income tax bases of assets and liabilities and for the expected future benefit to be derived from tax credits and loss carry forwards. Such deferred income tax computations are measured based on enacted tax laws and rates applicable to the years in which these temporary differences are expected to be recovered or settled. A valuation allowance is provided against net deferred tax assets if, based on the available evidence, it is more likely than not that some or all of the net deferred tax assets will not be realized.
The Company determines whether it is more likely than not that a tax position will be sustained upon examination. If it is not more likely than not that a position will be sustained, none of the benefit attributable to the position is recognized. The tax benefit to be recognized for any tax position that meets the more likely than not recognition threshold is calculated as the largest amount that is more than 50% likely of being realized upon resolution of the uncertainty. The Company accounts for interest and penalties related to uncertain tax positions as part of its income tax provision.
Recently Adopted and Recently Issued Accounting Pronouncements
New accounting pronouncements are issued periodically by the Financial Accounting Standards Board (FASB) and are adopted by the Company as of the specified effective dates. Unless otherwise disclosed below, the Company believes that recently issued and adopted pronouncements will not have a material impact on the Company’s financial position, results of operations and cash flows or do not apply to the Company’s operations.
Recently Adopted Accounting Pronouncements
On July 4, 2025, the One Big Beautiful Bill Act (“OBBBA”) was enacted. The legislation restored immediate deductibility of domestic research and development expenditures and reinstated 100% bonus depreciation. Although these provisions may increase our net operating loss carryforwards and reduce the deferred tax asset associated with capitalized R&D, we continue to maintain a full valuation allowance. Accordingly, OBBBA did not have a material impact on our results of operations or liquidity for the year ended December 31, 2025. We elected to continue to defer R&D costs and will continue to monitor any future guidance related to OBBBA.
In December 2023, the FASB issued ASU 2023-09—Income Taxes(Topic 740): Improvements to Income Tax Disclosures. This ASU was issued to address investor requests for more transparency about income tax information through improvements to income tax disclosure primarily related to the rate reconciliation and income taxes paid information, and to improve the effectiveness of income tax disclosures. The prospective adoptionof this ASU resulted in additional annual disclosure, butdid not impact our consolidated financial position, results of operations, or cash flows.
Recently Issued Accounting Pronouncements
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. The amendments in ASU 2024-03 address investor requests for more detailed expense information and require additional disaggregated disclosures in the notes to financial statements for certain categories of expenses that are included on the face of the income statement. This guidance is effective for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027, with early adoption permitted. The Company is currently evaluating the impact the adoption of this ASU will have on its consolidated financial statement disclosures.
Revenue
For the years ended December 31, 2025 and 2024, the Company’s product revenues were primarily from the Company’s existing supply agreements with commercial partners. For the years ended December 31, 2025 and 2024, the Company’s product revenues were made up of $1.6 million and $3.1 million, respectively, primarily from sales of YUTIQ®.
License and Collaboration Agreements and Royalty Income
ANI Product Rights Agreement and Commercial Supply Agreement
On May 17, 2023, the Company entered into a PRA with ANI. Under the PRA, the Company granted to ANI an exclusive and sublicensable right and license (the License) under the Company’s and its affiliates’ interest in certain of the Company’s and its affiliates’ intellectual property to develop, manufacture, sell, commercialize, and otherwise exploit certain products, including YUTIQ®, for the treatment and prevention of uveitis in the entire world except Europe, the Middle East and Africa (EMEA).
Additionally, pursuant to the PRA, the Company transferred and assigned to ANI certain assets and certain contracts with third parties related to YUTIQ®, including the new drug application for YUTIQ® (collectively, the Asset Transfer). Pursuant to the PRA, ANI paid the Company a $75.0 million upfront payment (the Upfront Payment). ANI also made four quarterly payments of $1.875 million to the Company totaling $7.5 million during 2024. ANI will also pay royalties to the Company from 2025 to 2028 at a percentage of low-to-mid double digits of ANI’s related U.S. annual net sales of certain products (including YUTIQ®) in excess of certain thresholds, beginning at $70 million in 2025, and increasing annually thereafter. Upon ANI’s payment of the Upfront Payment and the 2024 quarterly payments, the licenses and rights granted to ANI automatically became perpetual and irrevocable. Payments received from ANI are non-refundable.
The Company and ANI also entered into a commercial supply agreement (CSA), pursuant to which, during the term of the PRA, the Company agreed to manufacture and exclusively supply to ANI agreed-upon quantities of YUTIQ® necessary for ANI to commercialize YUTIQ® in the United States at certain cost plus amounts, subject to adjustments and potential extensions and terminations set forth in the CSA. The CSA with ANI automatically terminated on May 31, 2025.
Revenue from sales of product supply to ANI under the CSA was $0.7 million and $2.6 million during the years ended December 31, 2025 and 2024, respectively. License and Collaboration revenue related to the PRA was $15.9 million and $37.1 million during the years ended December 31, 2025 and 2024, respectively. License and collaboration revenue, related to additional transitional services was $0.6 million and $0.7 million during the years ended December 31, 2025 and 2024, respectively.
SWK Royalty Purchase Agreement
On December 17, 2020 the Company entered into a royalty purchase agreement (RPA) with SWK. Pursuant to the RPA, the Company sold its right to receive royalty payments on future sales of products subject to a licensing and development agreement, as amended, with ANI (the Amended ANI Agreement) for an upfront cash payment of $16.5 million. The Company classified the proceeds received from SWK as deferred revenue at inception of the RPA and is recognizing revenue as royalty payments are made from ANI to SWK. The Company recognized $12.7 million and $1.1 million of royalty income related to the RPA for the years ended December 31, 2025 and 2024, respectively. As of December 31, 2024, the Company classified $1.8 million and $10.9 million as current and non-current deferred revenue recognized under the RPA, respectively.
On March 18, 2025, ANI announced that it completed the buyout of its 3.125% perpetual royalty obligation to SWK on worldwide net revenues of ILUVIEN® and YUTIQ® for a one-time payment of $17.25 million. Under the terms of the agreement, upon making the buyout payment, no further royalty is due to SWK on net revenues beginning January 1, 2025, forward. As a result, the Company terminated the RPA effective March 18, 2025.
Ocumension Therapeutics
The Company entered into an Exclusive License Agreement on November 2, 2018, as amended by a Memorandum of Understanding dated March 1, 2019, a Memorandum of Understanding dated August 18, 2020, a Supply and Quality Agreement on February 19, 2019 and a Memorandum of Understanding on August 26, 2024. Pursuant to the license agreement and Memorandum of Understanding signed with the Company, Ocumension has:
An exclusive license for the development and commercialization of its three-year micro insert using the Durasert® technology for the treatment of posterior segment uveitis of the eye (YUTIQ® in the U.S.) in Mainland China, Hong Kong, Macau, and Taiwan at its own cost and expense in return for royalties based on sales with the Company supplying products for clinical trials and commercial sale;
An exclusive license for the development and commercialization in Mainland China, Hong Kong, Macau, and Taiwan of DEXYCU® for the treatment of post-operative inflammation following ocular surgery at its own cost and expense in return for royalties based on sales with the Company supplying product for clinical trials and commercial sale; and
Exclusive rights to develop and commercialize YUTIQ® and DEXYCU® products under its own brand names in South Korea and other jurisdictions across Southeast Asia in Brunei, Burma (Myanmar), Cambodia, Timor-Leste, Indonesia, Laos, Malaysia, the Philippines, Singapore, Thailand, and Vietnam (the Territory), at its own cost and expense in return for royalties based on sales with the Company supplying product for clinical trials and commercial sale.
The right and obligation to manufacture YUTIQ®, either by itself or through affiliates or sub-contractors, for sale and use in the Territory following completion of a technology and know-how transfer from the Company to Ocumension.
During both years ended December 31, 2025 and 2024, the Company recognized $0.9 million and $0.5 million of revenue from sales of product supply to Ocumension under the supply agreement and recorded this amount in product sales, net on the condensed consolidated statements of operations and comprehensive loss, respectively. The Company recognized approximately $0.1 million, of license and collaboration revenue related to additional technical assistance during the years ended December 31, 2025 and 2024. The Company also recorded royalty income of $0.4 million and $0.5 million during the years ended December 31, 2025 and 2024, respectively.
Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets consisted of the following (in thousands):
| December 31,2025 | December 31,2024 | |
|---|---|---|
| Prepaid expenses | $3,515 | $2,339 |
| Prepaid clinical | 14,626 | 5,737 |
| Other | 1,964 | 1,405 |
| Total prepaid expenses and other current assets | $20,105 | $9,481 |
As of December 31, 2025 and 2024, the Company had $5.4 million of prepaid clinical expense included in other assets on its consolidated balance sheets.
Inventory
Inventory consisted of the following (in thousands):
| December 31,2025 | December 31,2024 | |
|---|---|---|
| Raw materials | $1,229 | $1,657 |
| Work in process | 584 | 648 |
| Total inventory | $1,813 | $2,305 |
Property and Equipment, Net
Property and equipment, net consisted of the following (in thousands):
| December 31, | December 31, | |
|---|---|---|
| 2025 | 2024 | |
| Property and equipment | $9,400 | $6,599 |
| Construction in process | 1,460 | 1,507 |
| Leasehold improvements | 4,180 | 4,128 |
| Gross property and equipment | 15,040 | 12,234 |
| Accumulated depreciation and amortization | (6,017) | (4,057) |
| Property and equipment, net | $9,023 | $8,177 |
Depreciation expense totaled $2.1 million and $1.5 million in the years ended December 31, 2025 and 2024, respectively.
Accrued Expenses
Accrued expenses consisted of the following (in thousands):
| December 31, | December 31, | |
|---|---|---|
| 2025 | 2024 | |
| Personnel costs | $14,534 | $11,830 |
| Clinical trial costs | 4,011 | 4,541 |
| Professional fees, contingencies and legal fees | 5,160 | 840 |
| Sales chargebacks, rebates and other revenue reserves | 62 | 147 |
| Other | 627 | 745 |
| Total accrued expenses | $24,394 | $18,103 |
Leases
On January 23, 2023, the Company entered into a lease agreement (Northbridge Lease) for its new standalone commercial manufacturing facility, including office and lab space located at 600 Commerce Drive, Northbridge, Massachusetts. The new 41,141 square-foot manufacturing facility is Current Good Manufacturing Practice (cGMP) compliant to meet U.S. FDA and European Medicines Agency (EMA) standards to support DURAVYU clinical supply and commercial readiness upon regulatory approval. In addition, the building has the capacity and capabilities for pipeline expansion. The lease includes a non-cancellable lease term offifteen years and four months, with two options to extend the lease term for two additional terms of either five years orten years at 95% of the then-prevailing fair market rent. The lease term, under ASC 842, commenced during the second quarter of 2024. The Company entered into an amendment to the Northbridge Lease, effective September 30, 2024. Pursuant to the amendment, the Company's obligation to pay base rent began on March 1, 2025. The Company is responsible for real estate taxes, maintenance, and other operating expenses applicable to the leased premises. The Company recognized an initial increase of $17.7 million to its lease liabilities and $17.9 million to its right-of-use (ROU) assets resulting from the Northbridge Lease during the second quarter of 2024.
Since the Company elected to account for each lease component and its associated non-lease components as a single combined component, all contract consideration was allocated to the respective lease components. The expected lease terms include non-cancellable lease periods. Renewal option periods have not been included in the determination of the lease terms as they are not deemed reasonably certain of exercise. Variable lease payments, such as common area maintenance, real estate taxes, and property insurance are not included in the determination of the lease’s ROU asset or lease liability.
As of December 31, 2025, the weighted average remaining term of the Company’s operating leases was 11.8 years and the weighted average discount rate was 11.75%. As of December 31, 2024, the weighted average remaining term of the Company’s operating leases was 12.6 years and the weighted average discount rate was 11.63%.
Supplemental balance sheet information related to operating leases as of December 31, 2025 and 2024, respectively, is as follows (in thousands):
| December 31, | December 31, | |
|---|---|---|
| 2025 | 2024 | |
| Other current liabilities – operating lease current portion | $2,022 | $1,247 |
| Operating lease liabilities – noncurrent portion | 20,772 | 21,858 |
| Total operating lease liabilities | $22,794 | $23,105 |
The elements of lease expense were as follows (in thousands):
| Year EndedDecember 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Lease expense included in: | ||
| Research and development | $3,994 | $2,739 |
| General and administrative | 259 | 260 |
| Variable lease costs | 341 | 255 |
| Total lease expense | $4,594 | $3,254 |
Cash paid for amounts included in the measurement of operating lease liabilities was $3.8 million and $1.2 million for the years ended December 31, 2025 and 2024, respectively.
The Company’s total future minimum lease payments under non-cancellable leases at December 31, 2025, were as follows (in thousands):
| Operating Leases | |
|---|---|
| 2026 | 4,482 |
| 2027 | 4,579 |
| 2028 | 3,469 |
| 2029 | 2,667 |
| Thereafter | 29,193 |
| Total lease payments | $44,390 |
| Less imputed interest | (21,596) |
| Total | $22,794 |
Stockholders’ Equity
Equity Financings
Common Stock Offerings
In October 2025, the Company sold 12,875,000 shares of its common stockand, to certain investors, in lieu of common stock, pre-funded warrants (PFWs) to purchase 1,500,000 shares of common stock, in an underwritten public offering at a price of $12.00 per share, including the exercise in full by the underwriters of their option to purchase an additional 1,875,000 shares of common stock. The gross proceeds of the offering to the Company were approximately $172.5 million. Underwriter discounts and commissions and other share issue costs totaled approximately $10.8 million.
In October 2024, the Company sold 14,636,363 shares of its common stock in an underwritten public offering at a price of $11.00 per share, including the exercise in full by the underwriters of their option to purchase an additional 1,909,090 shares of common stock. The gross proceeds of the offering to the Company were approximately $161.0 million. Underwriter discounts and commissions and other share issue costs totaled approximately $10.2 million.
ATM Facility
In August 2020, the Company entered into an at-the-market facility (the ATM Facility) with Cantor Fitzgerald & Co (Cantor). Pursuant to the ATM Facility, the Company may, at its option, offer and sell shares of its common stock from time to time, through or to Cantor, acting as sales agent. The Company will pay Cantor a commission of 3.0% of the gross proceeds from any future sales of such shares.
During the year ended December 31, 2025, the Company sold 825,844 shares of common stock under the ATM facility at a weighted average price of $14.10 per share for gross proceeds of approximately $11.6 million. Share issue costs, including sales agent commissions, totaled approximately $0.5 million.
During the year ended December 31, 2024, the Company sold 1,299,506 shares of its common stock under the ATM facility at a weighted average price of $9.36 per share for gross proceeds of approximately $12.2 million. Share issue costs, including sales agent commissions, totaled approximately $0.4 million.
Warrants to Purchase Common Shares
Pursuant to a credit agreement, the Company issued a warrant to SWK to purchase (i)40,910 shares of the Company’s common stock on March 28, 2018, at an exercise price of $11.00 per share with aseven-year term and (ii)7,773 shares of the Company’s common stock on June 26, 2018, at an exercise price of $19.30 per share with aseven-year term.
In January 2024, SWK exercised their warrants in full via cashless exercise resulting in the net share issuance of 25,666 shares.
The Company issued 3,272,727 shares of PFWs to purchase common stock, in connection with the November 2021 underwritten public offering. On April 18, 2024,2,181,818 PFWs were exercised in full as a cashless exercise, resulting in a net issuance of 2,180,776 shares of common stock.
The Company issued 1,500,000 shares of PFWs to purchase common stock, in connection with the October 2025 underwritten public offering.
As of December 31, 2025 and 2024,2,590,909 and 1,090,909 PFWs were outstanding, respectively. The PFWs were included in the basic and diluted net loss per share calculation during the year ended December 31, 2025.
Share-Based Payment Awards
Equity Incentive Plans
The 2023 Long-Term Incentive Plan (the “2023 Plan”), approved by the Company’s stockholders on June 20, 2023 (the “Adoption Date”), originally provided for the issuance of up to 3,500,000 shares of the Company’s common stock reserved for issuance under the 2023 Plan plus any additional shares of the Company’s common stock that were available for grant under the 2008 and the 2016 Incentive Plan (the “2008 & 2016 Plan”) at the Adoption Date or would otherwise become available for grant under the 2008 Plan as a result of subsequent termination or forfeiture of awards under the 2008 or 2016 Plan. Prior to June 18, 2025, the maximum aggregate number of shares available for issuance under the 2023 Plan was equal to (i)7,500,000 shares, plus (ii)184,904 shares that were previously available for grant under the Company’s 2016 Equity Incentive Plan (the 2016 Plan) that were transferred to the 2023 Plan on June 20, 2023, plus (iii) any shares granted under the Company’s 2008 Equity Incentive Plan or 2016 Plan (collectively, the Prior Plans) that, on or after the effective date of the 2023 Plan, become available as a result of the termination or forfeiture of awards under the Prior Plans. At the Company’s Annual Meeting of Stockholders held on June 18, 2025, the Company’s stockholders approved an amendment to the 2023 Plan to increase the number of shares authorized for issuance by 2,900,000 shares to 10,400,000 shares under the 2023 Plan. At December 31, 2025, a total of approximately 4,727,914 shares were available for new awards under the 2023 Plan.
Starting March 2022, the Company granted non-statutory stock options to new employees as inducement awards to enter into employment with the Company. The grants were approved by the Compensation Committee of the Board of Directors and awarded in accordance with Nasdaq Listing Rule 5635(c)(4). Although not awarded under any equity incentive plans, the grants are subject to and governed by the terms and conditions of the applicable plan in effect at the time of the grant.
Stock Options
The following table provides a reconciliation of stock option activity under the Company’s equity incentive plan and for inducement awards for the year ended December 31, 2025:
| Number ofOptions | WeightedAverageExercisePrice | WeightedAverageRemainingContractualLife | AggregateIntrinsicValue | |
|---|---|---|---|---|
| (in years) · (in thousands) | ||||
| Outstanding at December 31, 2024 | 7,670,647 | $12.47 | 7.43 | 7,478 |
| Granted | 2,919,985 | 9.15 | ||
| Exercised | (270,895) | 5.43 | ||
| Forfeited | (409,589) | 11.14 | ||
| Expired | (244,306) | 19.56 | ||
| Outstanding at December 31, 2025 | 9,665,842 | $11.54 | 7.38 | $73,168 |
| Exercisable at December 31, 2025 | 5,034,273 | $12.36 | 6.18 | $35,544 |
The Company's stock options generally vest over four years with 25% vesting after one year of service followed by ratable monthly vesting over the remaining three years. Nonemployee awards are granted similar to the Company’s employee awards. All option grants have a 10-year term.
The Company recognizes stock-based compensation expense over the requisite service period based on the grant date fair value of the award. The Company has elected to use the Black-Scholes option pricing model to determine the fair value of awards granted.
The determination of the fair value of stock-based awards utilizing the Black-Scholes model is affected by the share price and a number of assumptions, including expected volatility, expected life, risk-free interest rate and expected dividends. The Company determined the expected volatility by using available historical price information. The expected life of the awards is estimated based on the simplified method. The risk-free interest rate assumption is based on observed interest rates appropriate for the terms of the awards. The dividend yield assumption is based on history and expectation of paying no dividends. Forfeitures have not been material in the periods presented.
The fair value of the share-based awards was measured with the following range of assumptions for theyears ended December 31, 2025 and 2024:
| Year ended December 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Option life (in years) | 5.3 - 6.08 | 5.5 - 6.08 |
| Stock volatility | 99% - 102% | 97% - 100% |
| Risk-free interest rate | 3.67% - 4.45% | 3.45% - 4.60% |
| Expected dividends | 0.0% | 0.0% |
The following table summarizes information about employee, non-executive director and external consultant stock options for the years ended December 31, 2025 and 2024 (in thousands except per share amounts):
| Year ended December 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Weighted average grant date fair value per share | 7.36 | $14.13 |
| Total cash received from exercise of stock options | 1,471 | 5,528 |
| Total intrinsic value of stock options exercised | 1,262 | 7,887 |
Time-Vested Restricted Stock Units
Time-vested restricted stock units (RSUs) issued to date under the 2016 Plan and the 2023 Plan generally vest on a ratable annual basis over three years. The related stock-based compensation expense is recorded over the requisite service period, which is the vesting period. The fair value of all time-vested RSUs is based on the closing share price of the Company’s common stock on the date of grant.
The following table provides a reconciliation of RSU activity under the 2016 Plan and the 2023 Plan for the year ended December 31, 2025:
| Number of Restricted Stock Units | Weighted Average Grant Date Fair Value | |
|---|---|---|
| Nonvested at December 31, 2024 | 1,315,629 | $11.74 |
| Granted | 846,308 | 8.40 |
| Vested | (626,222) | 10.33 |
| Forfeited | (62,177) | 12.92 |
| Nonvested at December 31, 2025 | 1,473,538 | $10.37 |
At December 31, 2025, the weighted average remaining vesting term of the RSUs was 1.4 years.
Employee Stock Purchase Plan
The Company’s Employee Stock Purchase Plan (the ESPP) allows qualified participants to purchase the Company’s common stock twice a year at 85% of the lesser of the average of the high and low sales price of the Company’s common stock on (i) the first trading day of the relevant offering period and (ii) the last trading day of the relevant offering period. The number of shares of the Company’s common stock each employee may purchase under this plan, when combined with all other employee stock purchase plans, is limited to the lower of an aggregate fair market value of $25,000 during each calendar year, or 5,000 shares of the Company’s common stock in any one offering period. The Company has maintained consecutive six-month offering periods since August 1, 2019. During the year ended December 31, 2025,119,122 shares of the Company’s common stock were issued pursuant to the ESPP.
The Company estimated the fair value of the option component of the ESPP shares at the date of grant using a Black-Scholes valuation model. For the years ended December 31, 2025 and 2024, the compensation expense from ESPP shares was $0.4 million and $0.2 million, respectively.
Stock-Based Compensation Expense
The Company’s consolidated statements of comprehensive loss included total compensation expense from stock-based payment awards for the years ended December 31, 2025 and 2024, respectively, as follows (in thousands):
| Year EndedDecember 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Compensation expense included in: | ||
| Research and development | $13,073 | $18,472 |
| General and administrative | 14,800 | 18,268 |
| Total | $27,873 | $36,740 |
During the years ended December 31, 2025 and December 31, 2024, the Company modified certain stock options and restricted stock awards resulting in incremental compensation expense of $0.3 million and $5.2 million, respectively.
At December 31, 2025, there was approximately $21.3 million of unrecognized compensation expense related to outstanding equity awards under the 2023 Plan, the 2016 Plan, the inducement awards and the ESPP that is expected to be recognized as expense over a weighted average period of approximately 1.64 years.
License and Asset Purchase Agreements
Equinox Science, LLC
In February 2020, the Company entered into an Exclusive License Agreement (the Equinox License Agreement) with Equinox, pursuant to which Equinox granted the Company an exclusive, sublicensable, royalty-bearing right and license to certain patents and other Equinox intellectual property to research, develop, make, have made, use, sell, offer for sale and import the compound vorolanib and any pharmaceutical products comprising the compound for local delivery to the eye for the prevention or treatment of age-related macular degeneration, diabetic retinopathy, and retinal vein occlusion using the Company’s proprietary localized delivery technologies (the Original Field), in each case, throughout the world except China, Hong Kong, Taiwan, and Macau (the Company Territory).
In consideration for the rights granted by Equinox, the Company (i) made a one time, non-refundable, non-creditable upfront cash payment of $1.0 million to Equinox in February 2020, and (ii) agreed to pay milestone payments totaling up to $50.0 million upon the achievement of certain development and regulatory milestones, consisting of (a) completion of a Phase 2 clinical trial for the compound or a licensed product, (b) the filing of a new drug application or foreign equivalent for the compound or a licensed product in the United States, European Union, or United Kingdom and (c) regulatory approval of the compound or a licensed product in the United States, European Union, or United Kingdom.
The Company also agreed to pay Equinox tiered royalties based upon annual net sales of licensed products in the Company Territory. The royalties are payable with respect to a licensed product in a particular country in the Company Territory on a country-by-country and licensed product-by-licensed product basis until the later of (i) twelve years after the first commercial sale of such licensed product in such country and (ii) the first day of the month following the month in which a generic product corresponding to such licensed product is launched in such country. The royalty rates range from the high-single digits to low-double digits depending on the level of annual net sales. The royalty rates are subject to reduction during certain periods when there is no valid patent claim that covers a licensed product in a particular country.
On May 2, 2022, concurrent with the Company entering into the Betta License Agreement, the Company entered into Amendment #1 to the Equinox License Agreement, pursuant to which the Original Field was expanded to cover the prevention or treatment of ophthalmology indications using the Company’s proprietary localized delivery technologies and certain conforming changes were made to the Equinox License Agreement in connection therewith.
For the year ended December 31, 2024, the Company recorded $5.0 million of R&D expenses in connection with the milestone payment for completion of a Phase 2 clinical trial for the compound or a licensed product under the Equinox License Agreement. No R&D expense was recorded for the year ended December 31, 2025 related to the Equinox License Agreement.
Fair Value Measurements
The following tables summarize the Company’s assets by significant categories carried at fair value measured on a recurring basis at December 31, 2025 and 2024, respectively, by valuation hierarchy (in thousands):
| CarryingValue | GrossUnrealizedGains | GrossUnrealizedLosses | Fair Value | CashEquivalents | Marketable Securities | |
|---|---|---|---|---|---|---|
| Level 1: | ||||||
| Money market funds | $89,072 | $— | $— | $89,072 | $89,072 | $— |
| Subtotal | $89,072 | $— | $— | $89,072 | $89,072 | $— |
| Level 2: | ||||||
| Commercial paper | $89,211 | $32 | $— | $89,243 | $4,990 | $84,253 |
| U.S. Treasury securities | 90,023 | 79 | (1) | 90,101 | — | 90,101 |
| U.S. Agency securities | 29,900 | 11 | — | 29,911 | — | 29,911 |
| Subtotal | $209,134 | $122 | $(1) | $209,255 | $4,990 | $204,265 |
| Total | $298,206 | $122 | $(1) | $298,327 | $94,062 | $204,265 |
| CarryingValue | GrossUnrealizedGains | GrossUnrealizedLosses | Fair Value | CashEquivalents | Marketable Securities | |
|---|---|---|---|---|---|---|
| Level 1: | ||||||
| Money market funds | $95,859 | $— | $— | $95,859 | $95,859 | $— |
| Subtotal | $95,859 | $— | $— | $95,859 | $95,859 | $— |
| Level 2: | ||||||
| Commercial paper | $94,817 | $26 | $(1) | $94,842 | $— | $94,842 |
| U.S. Treasury securities | 114,599 | 120 | (8) | 114,711 | — | 114,711 |
| U.S. Agency securities | 61,605 | 53 | (2) | 61,656 | — | 61,656 |
| Subtotal | $271,021 | $199 | $(11) | $271,209 | $— | $271,209 |
| Total | $366,880 | $199 | $(11) | $367,068 | $95,859 | $271,209 |
At December 31, 2025, a total of $89.1 million or 94.7% of the Company’s interest-bearing cash equivalent balances were concentrated in one institutional money market fund that has investments consisting primarily of Repurchase Agreements, U.S Treasuries, and U.S. Government Agency Debts.
At December 31, 2024, a total of $95.9 million or 100% of the Company’s interest-bearing cash equivalent balances were concentrated in one institutional money market fund that has investments consisting primarily of Repurchase Agreements, U.S Treasuries, and U.S. Government Agency Debts.
Retirement Plans
The Company operates a defined contribution plan intended to qualify under Section 401(k) of the U.S. Internal Revenue Code. Participating U.S. employees may contribute a portion of their pre-tax compensation, as defined, subject to statutory maximums. The Company matches employee contributions up to 6% of eligible compensation, subject to a stated calendar year Internal Revenue Service maximum.
The Company contributed a total of $2.3 million and $1.4 million for the years ended December 31, 2025 and 2024, respectively, in connection with these retirement plans.
Income Taxes
The components of loss before income taxes are as follows (in thousands):
| Year ended | Year Ended | |
|---|---|---|
| December 31, | December 31, | |
| 2025 | 2024 | |
| U.S. operations | $(231,783) | $(130,880) |
| Non-U.S. operations | 100 | 100 |
| Loss before income taxes | $(231,683) | $(130,780) |
A reconciliation of the U.S. federal statutory income tax rate to the Company’s effective income tax rate is as follows:
| December 31, · December 31, | ||||||
|---|---|---|---|---|---|---|
| 2025 · 2024 | ||||||
| U.S. Federal Statutory Rate | (48,654) | 21.0 | % | (27,462) | 21.0 | % |
| State and Local Income Taxes | 147 | (0.1) | (9,242) | 7.1 | ||
| Tax Credits | ||||||
| Federal R&D Tax Credits | (2,988) | 1.3 | (1,587) | 1.2 | ||
| Changes in Valuation Allowances | 47,723 | (20.6) | 38,993 | (29.8) | ||
| Non-Taxable or Nondeductible Items | 715 | (0.3) | (1,171) | 0.9 | ||
| Changes in Unrecognized Tax benefits | — | — | — | — | ||
| Other Adjustments | ||||||
| Section 162 (m) - prior period generation | 3,024 | (1.3) | — | — | ||
| Other Adjustments | 219 | (0.1) | 559 | (0.5) | ||
| Effective Tax Rate | 186 | (0.1) | % | 90 | (0.1) | % |
In 2025 and 2024, Massachusetts comprised the majority of the state taxes.
The significant components of defe rred income taxes are as follows (in thousands):
| December 31, | December 31, | |
|---|---|---|
| 2025 | 2024 | |
| Deferred tax assets: | ||
| Net operating loss carryforwards | $115,213 | $102,514 |
| Capitalized R&D | 90,533 | 45,965 |
| Deferred revenue | — | 7,824 |
| Lease liability | 6,214 | 6,340 |
| Stock-based compensation | 23,247 | 17,717 |
| Tax credits | 17,145 | 10,503 |
| Other | 5,283 | 298 |
| Total deferred tax assets | 257,635 | 191,161 |
| Deferred tax liabilities: | ||
| Right-of-use assets | 5,485 | 5,737 |
| Total deferred tax liabilities | 5,485 | 5,737 |
| Deferred tax assets, net | 252,150 | 185,424 |
| Valuation allowance | 252,150 | 185,424 |
| Total deferred tax liability | $— | $— |
The valuation allowance generally reflects limitations on the Company’s ability to use the tax attributes and reduces the value of such attributes to the more-likely-than-not realizable amount. Management assessed the available positive and negative evidence to estimate if sufficient taxable income will be generated to use the existing net deferred tax assets. Based on a weighting of the objectively verifiable negative evidence in the form of cumulative operating losses over the three-year period ended December 31, 2025, management believes that it is not more likely than not that the deferred tax assets will be realized and, accordingly, a full valuation allowance has been established. The valuation allowance increased $66.7 million and $39.0 million for the years ended December 31, 2025 and 2024, respectively, with such increases attributed to the re-measurement of the net deferred tax assets at the year-end dates.
The Company has tax net operating loss and tax credit carry forwards in its individual tax jurisdictions, including approximately $49.3 million related to our 2018 acquisition of Icon Bioscience, Inc. At December 31, 2025, the Company had U.S. federal net operating loss carry forwards of approximately $407.2 million, which expire at various dates between calendar years 2025 and 2039. The utilization of certain of these loss and tax credit carry forwards may be limited by Sections 382 and 383 of the Internal Revenue Code as a result of historical or future changes in the Company’s ownership. At December 31, 2025, the Company had state net operating loss carry forwards of approximately $415.0 million, which expire between 2033 and 2040, as well as U.S. federal and state research and development tax credit carry forwards of approximately $18.3 million, which expire at various dates between calendar years 2025 and 2040. In addition, at December 31, 2025, the Company had net operating loss carry forwards in the UK of £20.9 million (approximately $25.3 million), which are not subject to any expiration dates.
The Company’s U.S. federal income tax returns for calendar years 2007 through 2024 remain subject to examination by the Internal Revenue Service. The Company’s UK tax returns for fiscal years 2006 through 2021 remain subject to examination.
Through December 31, 2025, the Company hadno unrecognized tax benefits in its consolidated statements of comprehensive loss andno unrecognized tax benefits in its consolidated balance sheets as of December 31, 2025 and 2024, respectively.
As of December 31, 2025 and 2024, the Company hadno accrued penalties or interest related to uncertain tax positions.
Cash paid for income taxes, net of refundswas $0.2 million and $0.1 millionas of December 31, 2025 and 2024 respectively.
Contingencies
Legal Proceedings
The Company is subject to various routine legal proceedings and claims incidental to its business.
U.S. Department of Justice Subpoena
As previously reported, in August 2022, the Company received a subpoena from the U.S. Attorney’s Office for the District of Massachusetts (DOJ), seeking production of documents related to sales, marketing, and promotional practices, including as pertain to DEXYCU®, which the Company commercialized from 2019 to 2023.
The Company has been cooperating fully with the government in connection with this matter, which stems from a sealedqui tamcomplaint filed in the U.S. District Court for the District of Massachusetts. The DOJ investigation relates to the False Claims Act and the Anti-Kickback Statute, and has focused on certain of the Company’s sales, marketing and promotional practices, including sampling practices, as pertain to DEXYCU during the period for which the Company commercialized this product.
As previously disclosed, the Company has been in discussions with the DOJ regarding a possible negotiated resolution. In the first quarter of 2026, the Company reached an agreement in principle with the DOJ to settle these matters for a payment of approximately $4.7 million plus interest (exclusive of attorneys’ fees payable by the Company to counsel for relators in thequi tam action which are expected to be at or about $0.2 million), with such agreement in principle subject to our reaching an agreement in principle with the Office of Inspector General of the Department of Health and Human Services (HHS). Under ASC 450, the Company recorded an approximately $4.7 million litigation contingency liability for this matter in its consolidated balance sheets as of December 31, 2025 based on the status of settlement discussions with the DOJ as of that date. As of December 31, 2024, the contingent liability amount related to this matter was not determinable, and accordingly, the Company didnot record a liability as of that date.
On February 26, 2026, the Company reached an agreement in principle with HHS to resolve matters related to the DOJ investigation on terms to include the Company entering into a corporate integrity agreement and HHS agreeing not to seek the Company’s exclusion from participation in Medicare, Medicaid, or other federal health care programs.
The agreements in principle are subject to negotiation, completion and execution of appropriate documents resolving these matters, including a settlement agreement and a corporate integrity agreement, which are expected to be finalized in the first half of 2026, and the final approval of the respective parties. There is no guarantee that the Company will be able to reach final agreement with DOJ or HHS. If the Company is not able to conclude a final resolution with the U.S. government, the DOJ may elect to proceed against the Company and seek damages in excess of the agreed in principle settlement amount, which potential liability cannot be reasonably estimated. Should a negotiated resolution of these matters not be achieved, the Company intends to defend itself vigorously.
Segment and Geographic Area Information
Business Segment
The Company operates inone business segment, which is the business of developing and commercializing innovative ophthalmic products for the treatment of eye diseases. Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker (CODM) in making decisions regarding resource allocation and assessing performance. The Company's CODM is the Chief Executive Officer. The CODM made such decisions and assessed performance at the Company level, as one segment.
Significant segment expenses are as follows (in thousands):
| December 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Total revenues | $31,371 | $43,273 |
| DURAVYU direct research and development expense | (149,293) | (70,818) |
| Other direct research and development expense | (3,036) | (2,656) |
| Personnel expense (including stock based compensation) | (83,471) | (84,730) |
| Facilities expense | (6,638) | (3,921) |
| Depreciation and amortization | (2,309) | (1,540) |
| Intellectual property expense | (898) | (1,361) |
| Legal, corporate and professional expenses | (12,916) | (10,177) |
| Provision for income taxes | (279) | (90) |
| Interest and other income, net | 11,751 | 15,074 |
| Other segment expenses* | (16,244) | (13,924) |
| Net loss | (231,962) | (130,870) |
*Other segment expenses include cost of goods sold and other expenses required to operate as a public company, such as insurance, software and contracted services.
Geographic Area Information
The following table summarizes the Company’s revenues and long-lived assets, net by geographic area (in thousands):
| Revenues · Long-Lived Assets, Net | ||||
|---|---|---|---|---|
| Year ended | Year ended | |||
| December 31, | December 31, | December 31, | December 31, | |
| 2025 | 2024 | 2025 | 2024 | |
| U.S. | $29,979 | $42,049 | $9,023 | $8,177 |
| China | 1,292 | 1,124 | — | — |
| UK | 100 | 100 | — | — |
| Consolidated | $31,371 | $43,273 | $9,023 | $8,177 |
Net Loss per Share
Basic net loss per share is computed by dividing the net loss by the weighted average number of common shares outstanding during the period. For periods in which the Company reports net income, diluted net income per share is determined by adding to the basic weighted average number of common shares outstanding the total number of dilutive common equivalent shares using the treasury stock method, unless the effect is anti-dilutive.
Common stock equivalents excluded from the calculation of diluted earnings per share because the effect would have been anti-dilutive were as follows:
| As of December 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Stock options | 9,665,842 | 7,670,647 |
| ESPP | 53,208 | 41,464 |
| Restricted stock units | 1,473,538 | 1,315,629 |
| 11,192,588 | 9,027,740 | |
Related Party Transactions
Nancy S. Lurker, the former Chief Executive Officer and Executive Vice Chair of the Company and current Vice Chair of the Board is a member of the board of directors of Altasciences, the parent company of Calvert Laboratories, Inc. (Calvert Labs), an entity with which the Company conducts business. The Company recorded $0.9 million and $1.5 million of research and development expense in the accompanying consolidated statements of comprehensive loss related to preclinical and analytical services provided by Altasciences for the years ended December 31, 2025 and 2024, respectively. Additionally, the Company recorded accounts payable of $0 and $0.4 million, and prepaid expenses of $0.3 million and $0.2 million in the accompanying consolidated balance sheets related to services provided by Altasciences, as of December 31, 2025 and 2024, respectively.
Subsequent Events
On February 13, 2026, the Company amended the lease for its headquarters in Watertown, Massachusetts. Under the amendment, the Company leased an additional 10,675 square feet of rentable area of the building, with a commencement date of May 1, 2026 and a term of 18 months.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.