Financial Data and Key Metrics Changes - For Q4 2024, total net revenue was $11.6 million, down from $14 million in Q4 2023. Net product revenue was $0.8 million compared to $0.7 million in the same period last year [33][34] - For the full year 2024, total net revenue was $43.3 million, down from $46 million in 2023. Net product revenue for 2024 was $3.2 million, significantly lower than $14.2 million in 2023 due to the sale of YUTIQ product rights [36][37] - Operating expenses for Q4 2024 totaled $56.8 million, up from $30.4 million in the prior year, primarily due to ongoing Phase 3 trials for DURAVYU [35] - The net loss for Q4 2024 was $41.4 million or $0.64 per share, compared to a net loss of $14.1 million or $0.33 per share in Q4 2023 [36] - The company ended 2024 with $371 million in cash and investments, up from $331 million at the end of 2023, and expects this will fund operations into 2027 and beyond [39] Business Line Data and Key Metrics Changes - The company is focusing on the DURAVYU program, with net product revenue expected to remain at immaterial levels as YUTIQ supply to ANI Pharmaceuticals will cease by May 31, 2025 [33][34] - Net revenue from royalties and collaborations for Q4 2024 was $10.8 million, down from $13.3 million in Q4 2023, primarily due to lower recognition of deferred revenue from YUTIQ [34] Market Data and Key Metrics Changes - DURAVYU is positioned as a leader in ocular sustained drug delivery, with ongoing Phase 3 trials in wet AMD and positive Phase 2 results in DME [11][12] - Enrollment in the LUGANO and Lucia trials for wet AMD is exceeding expectations, with completion anticipated in the second half of 2025 [13][28] Company Strategy and Development Direction - The company aims to be the first to submit a new drug application for a six-month intravitreal wet AMD program, which could capture significant market share [14][27] - The strategic focus is on advancing DURAVYU through clinical trials and preparing for commercial launch, with a strong emphasis on patient-centric trial design [15][30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing clinical trials and the potential for DURAVYU to transform treatment for retinal diseases, highlighting the strong safety and efficacy data [10][30] - The company plans to engage with regulatory agencies regarding the pivotal trial design for DME, with a meeting expected in the second quarter of 2025 [26][89] Other Important Information - The Northbridge manufacturing facility is operational and ready for registration batch manufacturing to support NDA filing [100][102] - The company has a solid patent protection strategy for DURAVYU, enhancing its competitive position in the market [22] Q&A Session Summary Question: How many clinical sites have been activated for the wet AMD pivotal program? - Most sites are activated in the U.S., with approximately 60 active sites per study. Plans include 60 to 80 sites for ex-U.S. studies [46][51] Question: Can you comment on the subgroup analysis of the 2.7% milligram versus aflibercept? - The analysis shows a strong dose response, with the 2.7% dose demonstrating significant improvements in visual acuity and fluid control compared to the control group [54][56] Question: What is the current status of the razuprotafib program? - Razuprotafib is on a lower priority but continues with preclinical activities. The focus remains on wet AMD execution [130] Question: What are the plans for post-marketing studies for DURAVYU? - Plans include studies comparing DURAVYU against current industry leaders, focusing on supplement-free rates and long-term efficacy [78][81] Question: What is the expected cash runway guidance? - The cash guidance extends into 2027, covering ongoing work for DURAVYU and wet AMD, but does not include the DME study itself [129]

Core Insights - EyePoint Pharmaceuticals reported a revenue of $11.59 million for the quarter ended December 2024, reflecting a decline of 17.4% year-over-year and a significant miss of 21.04% against the Zacks Consensus Estimate of $14.68 million [1] - The company's earnings per share (EPS) was -$0.64, worsening from -$0.33 in the same quarter last year, with a surprise of -56.10% compared to the consensus estimate of -$0.41 [1] Revenue Breakdown - Royalty income was reported at $0.22 million, falling short of the estimated $0.35 million by three analysts, representing a year-over-year decline of 10.4% [4] - Revenue from license and collaboration agreements was $10.59 million, below the average estimate of $13.86 million, marking an 18.7% decrease year-over-year [4] - Product sales, net, reached $0.77 million, slightly exceeding the two-analyst average estimate of $0.70 million, showing a year-over-year increase of 3.3% [4] Stock Performance - Over the past month, shares of EyePoint Pharmaceuticals have decreased by 20.2%, contrasting with a decline of 4.1% in the Zacks S&P 500 composite [3] - The stock currently holds a Zacks Rank 4 (Sell), indicating potential underperformance relative to the broader market in the near term [3]

Financial Performance - EyePoint Pharmaceuticals reported a quarterly loss of $0.64 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.41, representing an earnings surprise of -56.10% [1] - The company posted revenues of $11.59 million for the quarter ended December 2024, missing the Zacks Consensus Estimate by 21.04%, and down from $14.03 million a year ago [2] - The current consensus EPS estimate for the upcoming quarter is -$0.54 on revenues of $5.46 million, and for the current fiscal year, it is -$2.52 on revenues of $13.21 million [7] Stock Performance - EyePoint Pharmaceuticals shares have declined approximately 18.4% since the beginning of the year, compared to a decline of -1.8% for the S&P 500 [3] - The stock currently holds a Zacks Rank 4 (Sell), indicating expectations of underperformance in the near future [6] Industry Outlook - The Medical - Biomedical and Genetics industry, to which EyePoint Pharmaceuticals belongs, is currently in the top 30% of over 250 Zacks industries, suggesting a favorable industry outlook [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact investor sentiment [5]

Financial Information - EyePoint Pharmaceuticals, Inc. provided an updated investor presentation on January 13, 2025, including financial information as of December 31, 2024[6] Clinical Plans and Achievements - The company highlighted its 2025 clinical plans and recent corporate and clinical achievements in a press release issued on the same date[7] Transparency and Communication - The investor presentation and press release are available on the company's website, indicating a focus on transparency and investor communication[6][7]

– Enrollment exceeding expectations in DURAVYU™ Phase 3 wet AMD clinical trials with LUGANO over 50% enrolled and LUCIA recruiting ahead of schedule – – Positive Phase 2 VERONA clinical trial of DURAVYU for DME met primary and secondary endpoints – – $371 million of cash and investments on December 31, 2024, providing cash runway into 2027 beyond topline DURAVYU Phase 3 wet AMD data expected in 2026 – WATERTOWN, Mass., March 05, 2025 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a compa ...

Core Insights - EyePoint Pharmaceuticals, Inc. is focused on developing innovative therapeutics for serious retinal diseases, with a commitment to improving patient lives [2][3] Company Overview - EyePoint is a clinical-stage biopharmaceutical company utilizing its proprietary bioerodible Durasert E technology for sustained intraocular drug delivery [2] - The lead product candidate, DURAVYU, is an investigational treatment for VEGF-mediated retinal diseases, currently in Phase 3 trials for wet age-related macular degeneration (wet AMD) and has completed Phase 2 trials for diabetic macular edema (DME) [2][4] - The company anticipates discussions with regulatory agencies in Q2 2025 regarding pivotal program plans based on positive Phase 2 results from the VERONA trial in DME [2] Pipeline Programs - Additional pipeline programs include EYP-2301, a TIE-2 agonist, and razuprotafib, both formulated in Durasert E to potentially enhance outcomes in serious retinal diseases [3] - Durasert technology has been safely administered to thousands of patient eyes across four FDA-approved products for various disease indications [3] Upcoming Investor Conferences - EyePoint management will participate in the Leerink Partners Global Healthcare Conference on March 11, 2025, and the Barclays 27th Annual Global Healthcare Conference on March 12, 2025 [5]

Core Viewpoint - EyePoint Pharmaceuticals, Inc. is set to report its fourth quarter and full-year 2024 financial results on March 5, 2025, during a conference call and live webcast [1] Company Overview - EyePoint Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing innovative therapeutics for serious retinal diseases [3] - The company utilizes its proprietary bioerodible Durasert E™ technology for sustained intraocular drug delivery [3] - EyePoint's lead product candidate, DURAVYU™, is an investigational treatment for VEGF-mediated retinal diseases, currently in Phase 3 clinical trials for wet age-related macular degeneration (wet AMD) and has completed a Phase 2 trial for diabetic macular edema (DME) [3][5] Pipeline and Development - The pipeline includes EYP-2301, a TIE-2 agonist, and razuprotafib, both formulated in Durasert E™ to potentially enhance outcomes in serious retinal diseases [4] - DURAVYU™ has been conditionally accepted by the FDA as the proprietary name for EYP-1901, although it has not yet received FDA approval [5] - Positive Phase 2 results from the VERONA clinical trial in DME have led the company to plan meetings with regulatory agencies in Q2 2025 to discuss pivotal program plans [3]

Core Insights - EyePoint Pharmaceuticals is set to present an update on its DURAVYU™ Phase 3 pivotal program for wet age-related macular degeneration (wet AMD) and additional analyses from the Phase 2 VERONA trial for diabetic macular edema (DME) at the TD Cowen 45th Annual Health Care Conference on March 4, 2025 [1][6] Company Overview - EyePoint Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative therapeutics for serious retinal diseases, utilizing its proprietary bioerodible Durasert E™ technology for sustained intraocular drug delivery [3][4] - The lead product candidate, DURAVYU™, is an investigational treatment for VEGF-mediated retinal diseases, combining vorolanib, a selective tyrosine kinase inhibitor, with Durasert E™ [3][5] - DURAVYU™ is currently in Phase 3 global pivotal trials for wet AMD, which is the leading cause of vision loss in individuals aged 50 and older in the U.S., and has recently completed a Phase 2 trial for DME [3][5] Pipeline Programs - EyePoint's pipeline includes EYP-2301, a TIE-2 agonist, and razuprotafib, both formulated in Durasert E™ to potentially enhance outcomes in serious retinal diseases [4] - The Durasert drug delivery technology has been safely administered to thousands of patients across four FDA-approved products for various disease indications [4] Regulatory Status - Vorolanib is exclusively licensed to EyePoint for the localized treatment of all ophthalmic diseases outside of specific regions in Asia [5] - DURAVYU™ has been conditionally accepted by the FDA as the proprietary name for EYP-1901, but it remains an investigational product and has not yet received FDA approval [5]

Summary of EyePoint Pharmaceuticals (EYPT) Conference Call Company Overview - **Company**: EyePoint Pharmaceuticals - **Focus**: Leader in sustained release drug delivery for retinal diseases, specifically targeting diabetic macular edema (DME) and wet age-related macular degeneration (AMD) with its lead product DuraView, which contains the drug virolinib [5][6] Key Points from the Conference Call Industry Context - **Market Size**: The global market for diabetic macular edema (DME) is projected to approach $4 billion within five years, with an estimated 50 million diabetics in the U.S. by then, and one in four expected to develop DME [14][15] - **Unmet Need**: There is a significant unmet need for durable treatments in DME, as many patients do not adhere to treatment schedules, leading to severe visual loss [15] Product Development and Trials - **DuraView**: - A sustained release drug delivery system that provides continuous dosing for at least six months [8][12] - Currently undergoing two global Phase III non-inferiority pivotal trials in wet AMD, with enrollment expected to complete in the second half of the year [6][34] - **VIRONA Trial**: - A Phase II clinical trial for DME showing promising results, including a best corrected visual acuity (BCVA) improvement of 7.1 letters and a significant central subfield thickness (CST) improvement of 76 microns [20][21] - 73% of patients in the DuraView 2.7 mg arm were supplement-free at six months compared to 50% in the control group [26][21] Safety and Efficacy - **Safety Profile**: No ocular or systemic serious adverse events (SAEs) reported in the trial, indicating a favorable safety profile for DuraView [21][30] - **Efficacy**: - DuraView demonstrated immediate bioavailability and sustained delivery, with significant improvements in both vision and anatomy observed as early as week four [31][32] - The trial's unique supplemental criteria contributed to the majority of supplements, but the overall results remained strong [20][19] Future Plans - **Phase III Protocol**: - Planning to discuss the proposed Phase III clinical protocol with regulatory agencies, aiming for a non-inferiority design [32][33] - Anticipating initiation of the pivotal program by the end of 2025, leveraging experience from ongoing trials to enhance efficiency [33][39] - **Manufacturing Facility**: A new 41,000 square foot manufacturing facility opened in October 2024, expected to supply DuraView for the DME Phase III trial and future commercial needs [37][38] Market Positioning - **Competitive Advantage**: DuraView's sustained release mechanism and favorable safety profile position it well against competitors, especially in a market where patients often struggle with treatment adherence [63][87] - **Regulatory Outlook**: Optimism regarding the potential for a single Phase III trial based on recent regulatory precedents [73] Analyst Questions and Responses - **Outlier Impact**: Discussion on how a single outlier patient affected the results, with confidence that larger trials will mitigate such effects [46][48] - **Market Acceptance**: The potential for DuraView to be widely accepted in the market due to its dosing schedule and safety profile, regardless of competing products [63][62] Conclusion EyePoint Pharmaceuticals is advancing its DuraView product through promising clinical trials, addressing a significant unmet need in the DME market. The company is well-positioned for future growth with a strong safety profile, innovative drug delivery technology, and a strategic plan for regulatory engagement and market entry.

Core Insights - EyePoint Pharmaceuticals announced positive six-month results from the Phase 2 VERONA clinical trial for DURAVYU, achieving its primary endpoint of extended time to first supplemental injection compared to aflibercept control [1][3] - DURAVYU 2.7mg showed a significant improvement in best corrected visual acuity (BCVA) with a gain of +7.1 letters and a reduction in central subfield thickness (CST) by 76 microns, alongside a two-thirds reduction in treatment burden [1][2][3] - The safety profile of DURAVYU remains favorable, with no ocular or systemic serious adverse events reported [1][3] Company Overview - EyePoint Pharmaceuticals is focused on developing innovative therapeutics for serious retinal diseases, utilizing its proprietary bioerodible Durasert E™ technology for sustained intraocular drug delivery [11] - The company plans to initiate a Phase 3 non-inferiority pivotal program for DURAVYU in diabetic macular edema (DME) by the end of 2025, following positive Phase 2 results [1][10] Clinical Trial Details - The Phase 2 VERONA trial involved 27 patients and compared two doses of DURAVYU (1.34mg and 2.7mg) against aflibercept control, with the primary endpoint being the time to first supplemental injection over 24 weeks [4] - Key secondary endpoints included changes in BCVA, CST, and diabetic retinopathy severity scale (DRSS) [4] Market Context - DME is a leading cause of vision loss among working-age adults, with a significant need for more durable treatment options as the prevalence of diabetes increases [6][4] - The number of diabetic retinopathy patients is projected to reach 16 million by 2050, highlighting the growing market for effective treatments [4] Future Outlook - EyePoint anticipates presenting interim data at an upcoming medical meeting and is preparing for discussions with the FDA regarding the Phase 3 trial initiation [5][2] - The company is also conducting ongoing pivotal trials in wet age-related macular degeneration (wet AMD), with results expected in 2026 [10][11]