EyePoint Pharmaceuticals, Inc.
For the period ended Jun 30, 2025. Filed Aug 7, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2025 · Filed Aug 7, 2025
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-03-31; filed 2025-05-08.
0000950170-25-066907
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-06-30; filed 2025-08-07.
0001193125-25-175418
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 117 previous paragraphs and 133 current paragraphs.
80 unchanged; 21 reworded; 28 added; 14 removed; 2 previous and 4 current paragraphs rearranged.
Tables are not compared: 3 previous and 5 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (28)
Current report
our belief that DURAVYU™ is on track to be the first-to-market of the current investigational sustained release treatments for wet AMD;
Current report
our belief that DURAVYU™ has two potential blockbuster indications;
Current report
risks and uncertainties include the timing, progress and results of the company’s clinical development activities, including DURAVYU™;
Current report
uncertainties and delays relating to communications with the U.S. Food and Drug Administration and the ability to obtain regulatory approval from FDA for the commercialization of DURAVYU™
Current report
the risk that results of clinical trials may not be predictive of future results, and interim and preliminary data are subject to further analysis and may change as more data becomes available;
Current report
unexpected safety or efficacy data observed during clinical trials;
Current report
uncertainties related to the regulatory authorization or approval process, and available development and regulatory pathways for approval of the Company’s product candidates;
Current report
changes in the regulatory and legislative environment;
Current report
changes in U.S. and international trade policies;
Current report
changes in expected or existing competition;
Current report
On July 29, 2025, we announced enrollment was completed in the pivotal Phase 3 LUCIA clinical trial evaluating DURAVYU™.
Current report
On May 27, 2025, we announced enrollment was completed in the pivotal Phase 3 LUGANO clinical trial evaluating DURAVYU™.
Current report
Royalty income decreased by $0.6 million, or 100%, to $0 for the three months ended June 30, 2025 compared to the same period the prior year. This decrease was due to the termination of the SWK royalty purchase agreement (RPA) on March 18, 2025.
Current report
Cost of sales decreased by $1.2 million, or 88%, to $0.2 million for the three months ended June 30, 2025 compared to the same period the prior year. This decrease was primarily due to immaterial products sales.
Current report
Research and development expenses increased by $25.7 million, or 86%, to $55.5 million for the three months ended June 30, 2025 compared to the same period the prior year. This increase was primarily attributable to (i) a $26.0 million increase in clinical trial costs related to ongoing DURAVYU™ Phase 3 clinical trials (LUGANO and LUCIA) for wet AMD, offset by a $5.0 million decrease due to a one-time license milestone payment in the second quarter of 2024, (ii) $2.2 million increase in personnel costs, (iii) $1.0 million increase in facility and IT expenses for our Northbridge commercial manufacturing facility, (iv) $0.9 million increase in other professional services to support Phase 3 clinical trials and (v) $0.6 million increase in clinical trial material expense for Phase 3 clinical trials. We anticipate R&D expenses will continue at similar levels in future periods due to our ongoing Phase 3 clinical trials and Northbridge commercial manufacturing facility.
Current report
Interest income from investments in marketable securities and institutional money market funds decreased by $0.8 million, or 22%, to $2.9 million for the three months ended June 30, 2025 compared to the same period the prior year. This decrease was primarily driven by lower cash available for investment in marketable securities.
Current report
Six Months Ended June 30, 2025 Compared to Six Months Ended June 30, 2024:
Current report
Product Sales, Net
Current report
License and Collaboration Agreement
Current report
License and collaboration agreement revenue decreased by $2.0 million, or 11%, to $16.4 million for the six months ended June 30, 2025 compared to the same period the prior year. This decrease was due to lower recognition of deferred revenue related to the agreement to license YUTIQ® product rights to ANI.
Current report
Royalty Income
Current report
Cost of Sales
Current report
Cost of sales decreased by $1.2 million, or 55%, to $1.0 million for the six months ended June 30, 2025 compared to the same period the prior year. This decrease was primarily due to lower product sales.
Current report
Research and Development
Current report
Sales and Marketing
Current report
General and Administrative
Current report
General and administrative expenses decreased by $1.1 million, or 4%, to $25.7 million for the six months ended June 30, 2025 compared to the same period the prior year. This decrease was primarily attributable to lower personnel costs driven by non-cash stock compensation.
Current report
Interest (Expense) Income
Removed paragraphs (14)
Previous report
the effectiveness and timeliness of our clinical trials, and the usefulness of the data;
Previous report
On January 8, 2025, we announced the appointment of renowned retina specialist and industry pioneer Reginald J. Sanders, M.D., FASRS to the Company’s Board of Directors.
Previous report
Phase 3 pivotal LUGANO and LUCIA trials for DURAVYU™ in wet AMD are exceeding enrollment expectations and the Company is on track to complete enrollment for both in the second half of 2025. The rapid enrollment to date continues to exceed the observed recruitment rates of comparable historical and ongoing wet AMD clinical trials with LUGANO and LUCIA having randomized over 90% and 50% of patients, respectively, into the trials. LUGANO and LUCIA are identical, global non-inferiority trials with every six-month re-dosing following a clear and recognized pathway for regulatory and commercial success, positioning DURAVYU™ to become a potential blockbuster franchise.
Previous report
The Phase 2 VERONA clinical trial of DURAVYU™ in DME met both primary and secondary endpoints. The 24-week data demonstrated a meaningful and sustained improvement in vision and anatomical control with a continued favorable safety profile.
Previous report
A subgroup analyses of supplement-free patients from the VERONA trial in DME demonstrated that DURAVYU™ 2.7mg significantly and rapidly (by week 4) improved vision and reduced fluid levels, demonstrating a BCVA improvement of +10.3 letters versus +3.0 letters for aflibercept control and a CST improvement of 117.4 microns versus 43.7 microns for aflibercept control at week 24. These results further underscore the differentiated profile of DURAVYU™ with compelling efficacy, favorable safety, and strong durability.
Previous report
o
Previous report
An assessment of the treatment burden in wet AMD treated with DURAVYU™ versus aflibercept from the Phase 2 DAVIO 2 clinical trial
Previous report
o
Previous report
Trial design of the global LUGANO and LUCIA pivotal Phase 3 trials in wet AMD
Previous report
o
Previous report
A 24-month Good Laboratory Practice (GLP) repeat-dose toxicology study of vorolanib intravitreal insert
Previous report
The 24-week topline results from the Phase 2 VERONA study in DME were accepted for presentation at the Retina World Congress in May 2025, which will highlight DURAVYU™’s potential to transform the treatment landscape in the second largest retinal disease market with its best-in-class safety and efficacy profile.
Previous report
Cost of sales remained consistent compared to the same period the prior year.
Reworded paragraphs (21)
Previous wording
Presented multiple datasets at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting in early May 2025, demonstrating DURAVYU™’s potential real-world application in multiple retinal disease indications and de-risked trial designs that position DURAVYU™ for clinical and commercial success. Presentations included:
Current wording
our belief that DURAVYU™’s potential real-world application in multiple retinal disease indications and de-risked trial designs position DURAVYU™ for clinical and commercial success;
Previous wording
our belief that our cash, cash equivalents, and investments in marketable securities of $318.2 million at March 31, 2025 will enable us to fund operations into 2027, beyond the topline data expected in 2026;
Current wording
our belief that our cash, cash equivalents, and investments in marketable securities of $255.7 million at June 30, 2025 will enable us to fund operations into 2027, beyond the topline data expected in 2026;
Previous wording
We are a company committed to developing and commercializing innovative therapeutics to help improve the lives of patients with serious retinal diseases. Our pipeline leverages our proprietary bioerodible Durasert E™ technology for sustained intraocular drug delivery. The Company’s lead product candidate, DURAVYU™, 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 bioerodible Durasert™. DURAVYU™ is presently in identical, global Phase 3 clinical trials (LUGANO and LUCIA) as a sustained delivery treatment 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, and recently completed a positive Phase 2 clinical trial for diabetic macular edema (DME) meeting primary and secondary endpoints. Additional pipeline programs include EYPT-2301, a promising TIE-2 agonist, razuprotafib, f/k/a AKB-9778, formulated in Durasert E™ to potentially improve outcomes in serious retinal diseases.
Current wording
We are a company committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases. Our pipeline leverages our proprietary bioerodible Durasert E™ technology for sustained intraocular drug delivery. The Company’s lead product candidate, DURAVYU™, f/k/a EYP-1901, 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 with bioerodible Durasert™. DURAVYU™ is presently in two global Phase 3 clinical trials (LUGANO and LUCIA) as a sustained delivery treatment 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, and completed a positive Phase 2 clinical trial for diabetic macular edema (DME) meeting primary and secondary endpoints. Additional pipeline programs include EYPT-2301, a promising TIE-2 agonist, razuprotafib, formulated in Durasert E™ to potentially improve outcomes in serious retinal diseases.
Previous wording
We are 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. We also expect 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.
Current wording
On May 27, 2025, we announced enrollment was completed in the pivotal Phase 3 LUGANO clinical trial evaluating DURAVYU™. We are focused on completing patient enrollment in the LUCIA clinical trial for DURAVYU™ in the third quarter of 2025 and reporting top-line data for both the LUGANO and LUCIA clinical trials in the second half of 2026. We also completed a positive EOP2 meeting with the US FDA in July 2025 and are waiting for the formal meeting minutes to finalize the pivotal program for DURAVYU™ in DME with an anticipated start in 2026.
Previous wording
Product sales, net represents the gross sales of YUTIQ® and DEXYCU® less provisions for product sales allowances. Product sales for the three months ended March 31, 2025 were consistent with the prior year period.
Current wording
Product sales, net represents the gross sales of YUTIQ® and DEXYCU® less provisions for product sales allowances. Product sales, net decreased by $1.1 million, or 100%, to $0 for the three months ended June 30, 2025 compared to the same period the prior year. This decrease was due to the fact that there were no shipments during the second quarter of 2025.
Previous wording
License and collaboration agreement revenue increased by $0.5 million, or 5%, to $11.0 million for the three months ended March 31, 2025 compared to the same period the prior year. This increase was due to higher recognition of deferred revenue related to the agreement to license YUTIQ® product rights to ANI.
Current wording
License and collaboration agreement revenue decreased by $2.4 million, or 31%, to $5.3 million for the three months ended June 30, 2025 compared to the same period the prior year. This decrease was primarily due to lower recognition of deferred revenue related to the agreement to license YUTIQ® product rights to ANI.
Previous wording
General and administrative expenses decreased by $0.2 million, or 2%, to $13.9 million for the three months ended March 31, 2025 compared to the same period the prior year.
Current wording
General and administrative expenses decreased by $0.9 million, or 7%, to $11.9 million for the three months ended June 30, 2025 compared to the same period the prior year. This decrease was primarily attributable to lower personnel costs driven by non-cash stock compensation.
Previous wording
Royalty income increased by $12.2 million, or 2641%, to $12.7 million for the three months ended March 31, 2025 compared to the same period the prior year. The increase in revenue recognized was due mainly to the recognition of the remaining $12.7 million of deferred SWK royalty revenue. 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.
Current wording
Royalty income increased by $11.6 million, or 1064%, to $12.7 million for the six months ended June 30, 2025 compared to the same period the prior year. The increase in revenue recognized was due mainly to the recognition of the remaining $12.7 million of deferred SWK royalty revenue. 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.
Previous wording
Research and development expenses increased by $28.4 million, or 94%, to $58.6 million for the three months ended March 31, 2025 compared to the same period the prior year. This increase was attributable primarily to (i) $28.5 million in increased clinical trial costs related to ongoing DURAVYU™ Phase 3 clinical trials (LUGANO and LUCIA) for wet AMD, (ii) $1.6 million higher clinical trial material expense for phase 3 clinical trials, (iii) $1.1 million higher facility and IT expenses offset by (iv) $2.9 million decrease in personnel costs driven by non-cash stock compensation. We anticipate clinical trial expenses will continue at similar levels in future periods due to our ongoing Phase 3 clinical trials.
Current wording
Research and development expenses increased by $54.1 million, or 90%, to $114.1 million for the six months ended June 30, 2025 compared to the same period the prior year. This increase was attributable primarily to (i) a $54.2 million increase in clinical trial costs related to ongoing DURAVYU™ Phase 3 clinical trials (LUGANO and LUCIA) for wet AMD, offset by a $5.0 million decrease due to a one-time license milestone payment in the second quarter of 2024, (ii) $2.1 million increase in other professional services to support Phase 3 clinical trials, (iii) $1.9 million increase in clinical trial material expense for Phase 3 clinical trials and (iv) $1.9 million increase in facility and IT expenses for our Northbridge commercial manufacturing facility, offset by a decrease of $1.0 million in personnel costs driven by non-cash stock compensation. We anticipate clinical trial expenses will continue at similar levels in future periods due to our ongoing Phase 3 clinical trials.
Previous wording
Interest income from investments in marketable securities and institutional money market funds decreased by $0.4 million, or 10%, to $3.6 million for the three months ended March 31, 2025 compared to the same period the prior year. This decrease was due to lower interest earned on cash invested in marketable securities driven by a general decrease in market interest rates.
Current wording
Interest income from investments in marketable securities and institutional money market funds decreased by $1.2 million, or 16%, to $6.5 million for the six months ended June 30, 2025 compared to the same period the prior year. This decrease was driven by lower cash available for investment in marketable securities and general decrease in market interest rates.
Previous wording
We have had a history of operating losses and an absence of significant recurring cash inflows from revenue, and at March 31, 2025 we had a total accumulated deficit of $918.2 million. Our operations have been financed primarily from sales of our equity securities, issuance of debt and a combination of license fees, milestone payments, royalty income and other fees received from collaboration partners.
Current wording
We have had a history of operating losses and an absence of significant recurring cash inflows from revenue, and at June 30, 2025 we had a total accumulated deficit of $977.6 million. Our operations have been financed primarily from sales of our equity securities, issuance of debt and a combination of license fees, milestone payments, royalty income and other fees received from collaboration partners.
Previous wording
At March 31, 2025, we had cash, cash equivalents, and investments in marketable securities of $318.2 million. We expect the cash, cash equivalents and investments on March 31, 2025 will enable us to fund operations into 2027. Due to the difficulty and uncertainty associated with the design and implementation of preclinical studies and clinical trials, we will continue to assess our cash and cash equivalents and future funding requirements. However, there is no assurance that additional funding will be achieved and that we will succeed in our future operations. We expect to continue to incur substantial additional operating losses for at least the next several years as we continue to develop our product candidates and seek marketing approval and, subject to obtaining such approval, the eventual commercialization of our product candidates. If we obtain marketing approval for any of our product candidates, we will incur significant sales, marketing, and manufacturing expenses. We also expect to continue to incur significant costs to comply with corporate governance, internal controls, and similar requirements associated with operating as a public reporting company.
Current wording
At June 30, 2025, we had cash, cash equivalents, and investments in marketable securities of $255.7 million. We expect the cash, cash equivalents and investments in marketable securities on June 30, 2025 will enable us to fund operations for the next 12 months and into 2027, beyond the topline data expected in 2026. Due to the difficulty and uncertainty associated with the design and implementation of preclinical studies and clinical trials, we will continue to assess our cash and cash equivalents and future funding requirements. However, there is no assurance that additional funding will be achieved and that we will succeed in our future operations. We expect to continue to incur substantial additional operating losses for at least the next several years as we continue to develop our product candidates and seek marketing approval and, subject to obtaining such approval, the eventual commercialization of our product candidates. If we obtain marketing approval for any of our product candidates, we will incur significant sales, marketing, and manufacturing expenses. We also expect to continue to incur significant costs to comply with corporate governance, internal controls, and similar requirements associated with operating as a public reporting company.
Previous wording
Operating cash outflows for the three months ended March 31, 2025 totaled $53.1 million primarily due to our net loss of $45.2 million reduced by $6.6 million of non-cash expenses, which included $7.8 million of stock-based compensation, partially offset by $1.7 million for amortization of discount on available for sale of marketable securities. We incurred cash outflows related to changes in working capital of $14.5 million, which included $23.5 million of deferred revenue related to the agreement to license YUTIQ® product rights to ANI offset by $9.0 million in other working capital adjustments.
Current wording
Operating cash outflows for the six months ended June 30, 2025 totaled $115.7 million primarily due to our net loss of $104.6 million reduced by $12.7 million of non-cash expenses, which included $14.7 million of stock-based compensation, partially offset by $2.9 million for amortization of discount on available for sale of marketable securities. We incurred cash outflows related to changes in working capital of $23.8 million, which included $28.6 million of deferred revenue related to the agreement to license YUTIQ® product rights to ANI offset by $4.8 million in other working capital adjustments.
Previous wording
Operating cash outflows for the three months ended March 31, 2024 totaled $31.2 million, primarily due to our net loss of $29.3 million reduced by $12.4 million of non-cash expenses, which included $12.7 million of stock-based compensation and $0.3 million for depreciation of property and equipment, partially offset by $0.6 million of amortization and accretion of marketable securities. We incurred cash outflows related to changes in working capital of $14.3 million, including $8.8 million of deferred revenue related to the agreement to license YUTIQ® product rights to ANI, and $5.5 million of other working capital changes.
Current wording
Operating cash outflows for the six months ended June 30, 2024 totaled $51.4 million primarily due to our net loss of $60.1 million reduced by $19.8 million of non-cash expenses, which included $21.4 million of stock-based compensation, partially offset by $2.3 million for amortization of discount on available for sale of marketable securities. This was further offset by changes in working capital of $11.0 million, including $14.3 million of deferred revenue related to the agreement to license YUTIQ® product rights to Alimera.
Previous wording
For the three months ended March 31, 2025, $39.8 million of net cash was provided by the sales of marketable securities, and $0.3 million was used for the purchase of property and equipment.
Current wording
For the six months ended June 30, 2025, $89.4 million of net cash was provided by the sales of marketable securities, and $1.5 million was used for the purchase of property and equipment.
Previous wording
For the three months ended March 31, 2024, $22.0 million of net cash was provided by the sales of marketable securities, and $1.2 million was used for the purchase of property and equipment.
Current wording
For the six months ended June 30, 2024, $137.5 million of net cash was used for the purchase of marketable securities, and $2.1 million was used for the purchase of property and equipment.
Previous wording
Net cash used in financing activities for the three months ended March 31, 2025 totaled $1.0 million and consisted mainly of the following:
Current wording
Net cash used in financing activities for the six months ended June 30, 2025 totaled $0.7 million and consisted mainly of the following:
Previous wording
$0.6 million provided by the exercise of stock options
Current wording
$0.9 million provided by the exercise of stock options
Previous wording
Net cash used in financing activities for the three months ended March 31, 2024 totaled $0.1 million and consisted of the following:
Current wording
Net cash provided by financing activities for the six months ended June 30, 2024 totaled $0.4 million and consisted of the following:
Previous wording
$4.6 million provided by the exercise of stock options
Current wording
$5.2 million from the exercise of stock options
Previous wording
$0.1 million used for payment of equity issue costs.
Current wording
$4.7 million used for the settlement of stock units and payment of equity issue costs
Rearranged current paragraphs (4)
Current report — wording carried from elsewhere
disruptions at the FDA, including due to a reduction in the FDA’s workforce and/or inadequate funding for the FDA;
Current report — wording carried from elsewhere
Product sales, net represents the gross sales of YUTIQ® and DEXYCU® less provisions for product sales allowances. Product sales, net decreased by $1.0 million, or 59%, to $0.7 million for the six months ended June 30, 2025 compared to the same period the prior year. This decrease was primarily driven by lower product shipments compared to the same period the prior year.
Current report — wording carried from elsewhere
The following table summarizes our research and development expenses for the six months ended June 30, 2025 and 2024:
Current report — wording carried from elsewhere
Sales and marketing expenses remained consistent and were immaterial, for the six months ended June 30, 2025 compared to the same period the prior year.
Rearranged previous paragraphs (2)
Previous report — wording carried elsewhere
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.
Previous report — wording carried elsewhere
$4.4 million used for the settlement of stock units to satisfy statutory tax withholding