Financial Data and Key Metrics Changes - The company ended 2024 with a strong balance sheet of $371 million in cash and investments and no debt, bolstered by a $161 million oversubscribed follow-on equity offering in Q4 2024 [17][32] - Total net revenue for Q4 2024 was $11.6 million, down from $14 million in Q4 2023, while net product revenue increased slightly to $0.8 million from $0.7 million [33] - For the full year 2024, total net revenue was $43.3 million, down from $46 million in 2023, with net product revenue dropping significantly to $3.2 million from $14.2 million 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 the prior year [36] Business Line Data and Key Metrics Changes - The company expects net product revenue to remain at immaterial levels as it will cease supplying YUTIQ to ANI Pharmaceuticals as of May 31, 2025 [33] - Net revenue from royalties and collaborations in Q4 2024 was $10.8 million, down from $13.3 million in Q4 2023, primarily due to lower recognition of deferred revenue from the license of YUTIQ product rights [34] Market Data and Key Metrics Changes - Enrollment in the Phase 3 trials for DURAVYU in wet AMD is exceeding expectations, with the LUGANO trial over 50% enrolled and the Lucia trial tracking ahead of schedule [13][28] - The company anticipates completion of enrollment in both trials in the second half of 2025, with top-line data expected in 2026 [14][39] Company Strategy and Development Direction - The company is focused on advancing DURAVYU, a sustained delivery program for treating wet AMD and DME, with a goal to be the first to submit a new drug application for a six-month intravitreal therapy [14][22] - The strategic focus is on clinical trials and regulatory approvals, with plans to engage in discussions with regulatory agencies regarding pivotal trial design for DME [26][90] - The company aims to provide a product that maintains stable vision for wet AMD patients with a six-month dosing interval, significantly improving upon current anti-VEGF treatments [27][119] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's position as a leader in ocular sustained drug delivery, with a compelling clinical pipeline representing multibillion-dollar opportunities [30][41] - The management highlighted the importance of successful execution in the ongoing Phase 3 trials and maintaining a strong cash runway to support operations into 2027 and beyond [39][130] Other Important Information - The company has established a state-of-the-art manufacturing facility in Northbridge, Massachusetts, which is now operational and focused on supporting NDA filing and commercial launch [100][102] - DURAVYU is positioned as a best-in-class therapy with a unique mechanism of action and a strong safety profile, differentiating it from existing treatments [12][22] Q&A Session Summary Question: How many clinical sites have been activated for the wet AMD pivotal program? - The company has most sites activated in the U.S., with approximately 60 active sites per study, and plans to have between 60 and 80 sites per study internationally [49][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 [56][57] Question: What is the current status of the razuprotafib program? - The razuprotafib program is on a lower priority as the company focuses on wet AMD, but preclinical activities will continue [130] Question: What are the plans for the DME pivotal program? - The company is awaiting feedback from regulatory agencies to design an efficient study for DME, with robust data from the Phase 2 study providing flexibility [71][90]

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.