EyePoint, Inc.
For the period ended Mar 31, 2025. Filed May 8, 2025.
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Mar 31, 2025 · Filed May 8, 2025
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Notes to Condensed Consolidated Financial Statements
Operations
The accompanying condensed consolidated financial statements of EyePoint Pharmaceuticals, Inc., a Delaware corporation (together with its subsidiaries, the Company), as of March 31, 2025 and for the three months ended March 31, 2025 and 2024 are unaudited. Certain information in the footnote disclosures of these financial statements has been condensed or omitted in accordance with the rules and regulations of the Securities and Exchange Commission. These financial statements should be read in conjunction with the Company’s audited consolidated financial statements and footnotes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024. In the opinion of management, these statements have been prepared on the same basis as the audited consolidated financial statements as of and for the year ended December 31, 2024, and include all adjustments, consisting only of normal recurring adjustments, that are necessary for the fair presentation of the Company’s financial position, results of operations, and cash flows for the periods indicated. The preparation of financial statements in accordance with United States (U.S.) generally accepted accounting principles requires management to make assumptions and estimates that affect, among other things, (i) reported amounts of assets and liabilities; (ii) disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements; and (iii) reported amounts of revenues and expenses during the reporting period. The results of operations for the three months ended March 31, 2025 are not necessarily indicative of the results that may be expected for the entire 2025 fiscal year or any future period.
The Company is 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™1, f/k/a EYP-1901, is an investigational sustained delivery treatment for anti-vascular endothelial growth factor (anti-VEGF) mediated retinal diseases combining vorolanib, a selective and patent-protected tyrosine kinase inhibitor with Durasert E™. DURAVYU™ is currently intwo identical, global Phase 3 clinical trials (LUGANO and LUCIA) for wet age-related macular degeneration (wet AMD), the leading cause of vision loss among people 50 years of age and older in the United States. DURAVYU™ also completed a Phase 2 clinical trial in diabetic macular edema (DME) meeting primary and secondary endpoints. Additional pipeline programs include EYP-2301, a promising TIE-2 agonist, razuprotafib, f/k/a AKB-9778, formulated in Durasert E™ to potentially improve outcomes in serious retinal diseases.
The Company is focused on completing patient enrollment in the LUGANO and LUCIA clinical trials for DURAVYU™ in the second half of 2025 and reporting top-line data in the second half of 2026. The Company also expects to meet with the US FDA in the second quarter of 2025 to finalize the pivotal program for DURAVYU™ in DME with an expectation for that program to potentially begin in 2026.
Liquidity
The Company had cash, cash equivalents and investments in marketable securities of$318.2 million at March 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 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$318.2 million at March 31, 2025 will enable the Company to fund its current and planned operations for at least the next twelve months from the date these condensed consolidated financial statements were issued. Actual cash requirements could differ from management’s projections due to many factors, including the timing and results of the Company’s clinical trials for DURAVYU™, additional investments in research and development programs, competing technological and market developments and the costs of any strategic acquisitions and/or development of complementary business opportunities.
DURAVYU™ has been conditionally accepted by the FDA as the proprietary name for EYP-1901. DURAVYU is an investigational product candidate; it has not been approved by the FDA. FDA approval and the timeline for potential approval is uncertain.
Summary of Significant Accounting Policies
The Company’s significant accounting policies are disclosed in the audited consolidated financial statements for the year ended December 31, 2024, and notes thereto, which are included in the Company’s Annual Report on Form 10-K that was filed with the Securities and Exchange Commission, or the SEC, on March 6, 2025, or the 2024 Form 10-K. Since the date of those financial statements, there have been no material changes to the Company's significant accounting policies.
Revenue
Product Revenue Reserves and Allowances
For the three months ended March 31, 2025, the Company’s product revenues were primarily from the Company’s existing commercial supply agreements with ANI. For the three months ended March 31, 2025 and 2024 the Company’s product revenues were made up of $0.6 million and $0.7 million from the sales of YUTIQ®, respectively. Sales of DEXYCU® for the three months ended March 31, 2025 and 2024 were immaterial.
The following table summarizes activity in each of the product revenue allowance and reserve categories for thethree months ended March 31, 2025 and 2024 (in thousands):
| Chargebacks,Discounts · Governmentand Other | ||||||
|---|---|---|---|---|---|---|
| and Fees · Rebates · Returns · Total | ||||||
| Beginning balance at January 1, 2025 | $5 | $142 | $147 | |||
| Provision related to sales in the current year | — | — | — | — | ||
| Adjustments related to prior period sales | — | 106 | (106) | — | ||
| Deductions applied and payments made | (3) | (28) | (36) | (67) | ||
| Ending Balance at March 31, 2025 | $2 | $78 | $— | $80 | ||
| Chargebacks,Discounts · Governmentand Other | ||||||
| and Fees · Rebates · Returns · Total | ||||||
| Beginning balance at January 1, 2024 | $83 | $— | $677 | $760 | ||
| Provision related to sales in the current year | — | — | — | — | ||
| Adjustments related to prior period sales | 70 | — | — | 70 | ||
| Deductions applied and payments made | (112) | — | (54) | (166) | ||
| Ending Balance at March 31, 2024 | $41 | $— | $623 | $664 | ||
Chargebacks, discounts and fees and rebates are recorded as a component of accrued expenses on the condensed consolidated balance sheets (See Note 6).
License and Collaboration Agreements and Royalty Income
ANI (formerly Alimera) Product Rights Agreement (PRA) and Commercial Supply Agreement
On May 17, 2023 (the Closing Date), the Company entered into a PRA with ANI (formerly Alimera). 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 (the Transferred 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. 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.
On the Closing Date, 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 Supply Transaction and together with the License and the Asset Transfer, the Transaction).
The Company classified the cash proceeds of the $75.0 million Upfront Payment received from ANI as deferred revenue at the Closing Date, pursuant to the PRA and the CSA because the License and supply units to be delivered under both agreements comprise a single, combined performance obligation as ANI will not have the right or ability to manufacture YUTIQ® (or have YUTIQ® manufactured by a third-party contract manufacturing organization) over the initialtwo-year term pursuant to the CSA. The combined performance obligation is satisfied over time using the units delivered output method to measure progress based on initial estimated supply units of YUTIQ® over thetwo-year term for purposes of recognizing revenue, such that revenue is recognized based on the value transferred in the form of units of product in the satisfaction of a performance obligation. Through this method, the Company compares the actual units delivered to date with the current estimated total to be delivered in the contractual term to measure the satisfaction of the performance obligation and recognize revenue. The Company will monitor its estimate of total units to be delivered to determine if an adjustment is needed to ensure that revenue is recognized proportionally for units delivered to date relative to the total units expected to be delivered for the combined performance obligation. Such estimates of the total delivery will be reassessed on an ongoing basis. If the Company determines that a change in estimate is necessary, it will adjust revenue using a cumulative catch-up method.
Revenue from sales of product supply to ANI under the CSA was $0.6 million and $0.7 million during thethree months ended March 31, 2025 and 2024, respectively. License and Collaboration revenue related to the PRA was $10.8 million and $10.4 million during thethree months ended March 31, 2025 and 2024, respectively. License and collaboration revenue, related to additional transitional services was $0.2 and $0.1 million for thethree months ended March 31, 2025 and 2024, respectively. As of March 31, 2025, the Company had $5.1 million and $0 as current and non-current deferred revenue recognized under the PRA. As of December 31, 2024, the Company had $15.9 million and $0 as current and non-current deferred revenue recognized under the PRA.
SWK Royalty Purchase Agreement
Pursuant to a royalty purchase agreement (RPA) with SWK Funding LLC (SWK), 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.
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.
The Company recognized $12.7 million and $0.3 million of royalty revenue related to the RPA for thethree months ended March 31, 2025 and 2024, respectively. As of March 31, 2025, the Company had no deferred revenue recognized under the RPA, 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.
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 the three months ended March 31, 2025 and 2024, the Company recognizedno revenue from sales of product supply to Ocumension under the supply agreement. Royalty income of $0 and $0.2 million, respectively, was recorded for thethree months ended March 31, 2025 and 2024. License and collaboration revenue related to additional technical assistance during the three months ended March 31, 2025 and 2024 was immaterial.
Exclusive License Agreement with Betta Pharmaceuticals, Co., Ltd.
On May 2, 2022, the Company entered into an exclusive license agreement (the Betta License Agreement) with Betta Pharmaceuticals Co., Ltd. (Betta), an affiliate of Equinox Sciences, LLC (Equinox). Under the Betta License Agreement, the Company granted to Betta an exclusive, sublicensable, royalty-bearing license under certain of the Company’s intellectual property to develop, use (but not make or have made), sell, offer for sale, and import the Company’s product candidate, DURAVYU™, an investigational sustained delivery treatment for anti-VEGF-mediated retinal diseases combining vorolanib, a selective and patent-protected tyrosine kinase inhibitor (TKI) with Durasert E™ (the Licensed Product), in the field of ophthalmology (the Betta Field) in the greater area of China, including China, the Hong Kong Special Administrative Region, the Macau Special Administrative Region, and Taiwan (the Betta Territory). The Company retained rights under the Company’s intellectual property to, among other things, conduct clinical trials on the Licensed Product in the Betta Field in the Betta Territory.
In consideration for the rights granted by the Company, Betta agreed to pay the Company tiered, mid-to-high single-digit royalties based upon annual net sales of Licensed Products in the Betta Territory. The royalties are payable on a Licensed Product-by-Licensed Product and region-by-region basis commencing on the first commercial sale of a Licensed Product in a region and continuing until the later of (i) the date that is twelve (12) years after first commercial sale of such Licensed Product in such region, and (ii) the first day of the month following the month in which a generic product corresponding to such Licensed Product is launched in the relevant region. The royalty rate is subject to reduction under certain circumstances, including when there is no valid claim of a licensed patent that covers a Licensed Product in a particular region.
Betta is responsible for all costs relating to development, registration, manufacturing, marketing, advertising, promotional, launch, and sales activities in connection with the Licensed Products in the Betta Field in the Betta Territory. Betta is required to use commercially reasonable efforts to develop, seek regulatory approval for, and commercialize at least one Licensed Product in the Betta Field in the Betta Territory. The Betta License Agreement also requires Betta to achieve certain diligence milestones relating to regulatory filings, patient dosing, and regulatory approval by certain specified deadlines set forth in the Betta License Agreement, subject to certain exceptions and extensions as set forth in the Betta License Agreement. Betta’s development activities will be conducted pursuant to a development plan subject to periodic updates. In the event that the Company conducts a global registrational clinical trial for a Licensed Product in the Betta Field, Betta will have the right to participate in such clinical trial by including clinical trial sites in the Betta Territory in accordance with the terms of the Betta License Agreement. The Company has also agreed to provide certain technology transfer and other support services to Betta subject to certain conditions and limitations set forth in the Betta License Agreement.
Revenue from license and collaboration revenue or royalty income for the three months ended March 31, 2025 and 2024 related to this agreement was immaterial.
Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets consisted of the following (in thousands):
| March 31,2025 | December 31,2024 | |
|---|---|---|
| Prepaid expenses | $2,074 | $2,339 |
| Prepaid clinical expenses | 2,743 | 5,737 |
| Other | 1,401 | 1,405 |
| Total prepaid expenses and other current assets | $6,218 | $9,481 |
As of March 31, 2025 and December 31, 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):
| March 31,2025 | December 31,2024 | |
|---|---|---|
| Raw materials | $1,790 | $1,657 |
| Work in process | 339 | 648 |
| Finished goods | — | — |
| Total inventory | $2,129 | $2,305 |
Accrued Expenses
Accrued expenses consisted of the following (in thousands):
| March 31, | December 31, | |
|---|---|---|
| 2025 | 2024 | |
| Personnel costs | $5,396 | $11,830 |
| Clinical trial costs | 11,333 | 4,541 |
| Professional fees | 595 | 840 |
| Sales chargebacks, rebates and other revenue reserves | 80 | 147 |
| Other | 774 | 745 |
| Total accrued expenses | $18,178 | $18,103 |
Leases
On March 31, 2025, the Company amended the lease for its headquarters in Watertown, Massachusetts to extend the term to May 31, 2028 for 8,383 square feet of laboratory and manufacturing operations space. During the first quarter of 2025, the Company recognized a $0.9 million increase to its lease liabilities and right-of-use (ROU) assets resulting from the lease amendment for the term extension of the laboratory and manufacturing operations space.
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 March 31, 2025 the weighted average remaining term of the Company’s operating leases was 12.1 years and the weighted average discount rate was 11.63%.
Supplemental balance sheet information related to operating leases are as follows (in thousands):
| March 31, | December 31, | |
|---|---|---|
| 2025 | 2024 | |
| Other current liabilities – operating lease current portion | $1,768 | $1,247 |
| Operating lease liabilities – noncurrent portion | 22,314 | 21,858 |
| Total operating lease liabilities | $24,082 | $23,105 |
The elements of lease expense were as follows (in thousands):
| Three Months EndedMarch 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Lease expense included in: | ||
| Research and development | $965 | $291 |
| General and administrative | 65 | 65 |
| Variable lease costs | 56 | 47 |
| Total lease expense | $1,086 | $403 |
Cash paid for amounts included in the measurement of operating lease liabilities was $0.6 million for thethree months ended March 31, 2025.
The Company’s total future minimum lease payments under non-cancellable leases at March 31, 2025 were as follows (in thousands):
| Operating Leases | |
|---|---|
| Remainder of 2025 | $3,226 |
| 2026 | 4,482 |
| 2027 | 4,579 |
| 2028 | 3,469 |
| 2029 | 2,667 |
| Thereafter | 29,193 |
| Total lease payments | $47,616 |
| Less imputed interest | (23,534) |
| Total | $24,082 |
Stockholders’ Equity
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 three months ended March 31, 2025 and 2024, the Company didnot sell any shares of its common stock under the ATM Facility.
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 Pre-Funded Warrants (PFW) 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.
As of March 31, 2025,1,090,909 PFWs were outstanding. The PFWs were included in the basic and diluted net loss per share calculation during thethree months ended March 31, 2025.
Share-Based Payment Awards
Equity Incentive Plan
Prior to June 20, 2024, the Company had authorized the issuance of 9,400,000 shares of the Company’s common stock under the 2016 Long-Term Incentive Plan (the 2016 Plan), of which 373,256 shares remained available for future grants.
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. At the Company’s Annual Meeting of Stockholders held on June 20, 2024, the Company’s stockholders approved an amendment to the 2023 Plan to increase the number of shares authorized for issuance by 4,000,000 shares. At March 31, 2025, a total of approximately 1,785,760 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 thethree months ended March 31, 2025:
| Number ofOptions | WeightedAverageExercisePrice | WeightedAverageRemainingContractualLife | AggregateIntrinsicValue | |
|---|---|---|---|---|
| (in years) · (in thousands) | ||||
| Outstanding at January 1, 2025 | 7,670,647 | $12.47 | 7.43 | 7,478 |
| Granted | 2,142,935 | 8.21 | ||
| Exercised | (68,779) | 3.26 | ||
| Forfeited | (187,786) | 10.64 | ||
| Expired | (162,331) | 21.13 | ||
| Outstanding at March 31, 2025 | 9,394,686 | $11.46 | 7.80 | $3,473 |
| Exercisable at March 31, 2025 | 4,262,537 | $12.51 | 6.36 | $2,032 |
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. Options to purchase a total of 847,572 shares of the Company’s common stock vested during the three months ended March 31, 2025.
In determining the grant date fair value of option awards during thethree months ended March 31, 2025, the Company applied the Black-Scholes option pricing model based on the following key assumptions:
| Three Months Ended | |
|---|---|
| March 31, | |
| Option life (in years) | 5.5 - 6.08 |
| Stock volatility | 99% - 102% |
| Risk-free interest rate | 3.99% - 4.45% |
| Expected dividends | 0.0% |
The following table summarizes information about employee, non-executive director and external consultant stock options for thethree months ended March 31, 2025 (in thousands except per share amount):
| Three Months | |
|---|---|
| Ended | |
| Weighted average grant date fair value per share | $6.62 |
| Total cash received from exercise of stock options | 224 |
| Total intrinsic value of stock options exercised | 209 |
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 3 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 thethree months ended March 31, 2025:
| Number of Restricted Stock Units | Weighted Average Grant Date Fair Value | |
|---|---|---|
| Nonvested at January 1, 2025 | 1,315,629 | $11.74 |
| Granted | 818,708 | 8.26 |
| Vested | (561,706) | 10.57 |
| Forfeited | (21,097) | 15.69 |
| Nonvested at March 31, 2025 | 1,551,534 | $10.27 |
At March 31, 2025, the weighted average remaining vesting term of the RSUs was 1.62 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 thethree months ended March 31, 2025,55,283 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. During both the three months ended March 31, 2025 and 2024, the compensation expense from ESPP shares was approximately $0.1 million.
Stock-Based Compensation Expense
The Company’s condensed consolidated statements of comprehensive loss included total compensation expense from stock-based payment awards as follows (in thousands):
| Three Months EndedMarch 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Compensation expense included in: | ||
| Research and development | $3,464 | $7,827 |
| General and administrative | 4,356 | 4,872 |
| $7,820 | $12,699 | |
At March 31, 2025, there was approximately $35.2 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 1.71 years.
Fair Value Measurements
The following tables summarize the Company’s assets by significant categories carried at fair value measured on a recurring basis by valuation hierarchy (in thousands):
| CarryingValue | GrossUnrealizedGains | GrossUnrealizedLosses | Fair Value | CashEquivalents | Marketable Securities | |
|---|---|---|---|---|---|---|
| Level 1: | ||||||
| Money market funds | $74,478 | $— | $— | $74,478 | $74,478 | $— |
| Subtotal | $74,478 | $— | $— | $74,478 | $74,478 | $— |
| Level 2: | ||||||
| Commercial paper | $76,510 | $6 | $(3) | $76,513 | $— | $76,513 |
| U.S. Treasury securities | 128,784 | 81 | (6) | 128,859 | — | 128,859 |
| U.S. Agency securities | 27,659 | 9 | (4) | 27,664 | — | 27,664 |
| Subtotal | $232,953 | $96 | $(13) | $233,036 | $— | $233,036 |
| Total | $307,431 | $96 | $(13) | $307,514 | $74,478 | $233,036 |
| 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 March 31, 2025, a total of $74.5 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. 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.
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 receivable, accounts payable, and accrued expenses approximate fair value because of their short-term maturity.
Segment 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):
| Three Months Ended | ||
|---|---|---|
| March 31, | ||
| 2025 | 2024 | |
| Total revenues | $24,453 | $11,684 |
| DURAVYU™ direct research and development expense | (41,898) | (13,710) |
| Other direct research and development expense | (985) | 293 |
| Personnel expense (including stock-based compensation) | (20,841) | (24,224) |
| Facilities expense | (1,409) | (628) |
| Depreciation and amortization | (497) | (303) |
| Intellectual property expense | (264) | (318) |
| Legal, corporate and professional expenses | (2,899) | (3,075) |
| Interest and other income, net | 3,642 | 4,037 |
| Other segment expenses* | (4,497) | (3,040) |
| Net loss | (45,195) | (29,284) |
*Other segment expenses include cost of goods sold, other expenses required to operate as a public company, such as insurance, software and contracted services.
Contingencies
Legal Proceedings
The Company is subject to various routine legal proceedings and claims incidental to its business, which management believes will not have a material effect on the Company’s financial position, results of operations or cash flows.
U.S. Department of Justice Subpoena
In August 2022, the Company received a subpoena from the U.S. Attorney’s Office for the District of Massachusetts seeking production of documents related to sales, marketing, and promotional practices, including as pertain to DEXYCU® (DOJ Investigation). The Company is cooperating fully with the government in connection with this matter. At this time, the Company is unable to predict the duration, scope or outcome of this matter or whether it could have a material impact on the Company's financial condition, results of operations, or cash flow.
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 March 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Stock options | 9,394,686 | 7,431,017 |
| ESPP | 23,635 | 3,718 |
| Restricted stock units | 1,551,534 | 1,403,152 |
| 10,969,855 | 8,837,887 | |
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 $0.2 million and $0.6 million of research and development expense in the accompanying condensed consolidated statements of operations and comprehensive loss related to preclinical and analytical services provided by Altasciences for thethree months ended March 31, 2025 and 2024, respectively. Additionally, the Company recorded accounts payable of $0.5 million and $0.4 million, and prepaid expenses of $0.2 million and $0.2 million in the accompanying consolidated balance sheets related to services provided by Altasciences, as of March 31, 2025 and December 31, 2024, respectively.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.