EyePoint Pharmaceuticals (EYPT) FY Conference June 10, 2025 02:40 PM ET Speaker0 Good afternoon. Thanks for listening. My name is Jay Duker. I'm the president and CEO of EyePoint. I'd like to thank Goldman Sachs for inviting us to present today. And we are a publicly traded company, and I will be giving some forward looking statements. If you'd like our full legal disclaimers, I invite you to go to our website. EyePoint is the leader in sustained release drug delivery for retinal diseases. Our lead asset is ...

Summary of EyePoint Pharmaceuticals (EYPT) 2025 Conference Call Company Overview - **Company**: EyePoint Pharmaceuticals (EYPT) - **Event**: 2025 Conference Call on May 27, 2025 - **Key Speakers**: George Elson (CFO), Romero Ribeiro (Chief Medical Officer) Key Points Industry and Product Development - EyePoint Pharmaceuticals is focused on the ophthalmology market, specifically targeting wet age-related macular degeneration (AMD) and diabetic macular edema (DME) with its product DuraVu, a potent and selective TKI (tyrosine kinase inhibitor) [3][4] - The company has completed enrollment in the first of two phase three pivotal trials for DuraVu, with over 400 patients enrolled in seven months [3] - The second trial, LUCHIA, is 60% enrolled and expected to complete enrollment in Q3 2025 [3] Clinical Trial Progress - Positive 24-week data for DuraVu in DME was reported earlier in the year, with an end-of-phase two meeting with the FDA scheduled for early July [5] - The company has a new 41,000 square foot facility in Northbridge, Massachusetts, capable of producing millions of doses for global launch [5][6] - The company has cash reserves extending into 2027, ensuring financial stability through upcoming data readouts [6] Market Positioning and Strategy - DuraVu is positioned as a maintenance therapy for wet AMD, aiming to reduce the treatment burden associated with frequent anti-VEGF injections [8][11] - The company emphasizes that DuraVu is not just another anti-VEGF but offers a new mechanism of action, potentially allowing patients to go longer periods without additional treatments [9][12] - The phase two data indicated that 66% of patients did not require anti-VEGF for six months, and 50% did not require it for up to one year [12][28] Safety and Efficacy - The safety profile of DuraVu has been excellent, with no serious adverse events reported related to the treatment [28] - The phase two study showed non-inferiority in visual outcomes compared to aflibercept, with an 80% reduction in treatment burden [28] Regulatory and Commercial Readiness - The company is preparing for NDA filing and has designed its trials to align with FDA requirements, including the use of sham controls [52][55] - A pre-commercial team is actively engaging with payers and key opinion leaders to ensure readiness for market entry [63] Future Milestones - Upcoming data readouts for the Lugano trial are expected in mid-2026, with the Lucia trial following shortly thereafter [62] - The company is focused on executing its commercial strategy and ensuring manufacturing capabilities are in place for a successful launch [63] Additional Insights - The retinal community is receptive to innovations that reduce treatment burdens, indicating a strong market need for DuraVu [22] - The design of the phase three trials incorporates lessons learned from phase two, ensuring robust patient selection and treatment criteria [32][41] - The company aims to provide flexibility in dosing, with a six-month label that allows for redosing if necessary [60] This summary encapsulates the key points discussed during the EyePoint Pharmaceuticals conference call, highlighting the company's strategic direction, clinical progress, and market positioning within the ophthalmology sector.

EyePoint Pharmaceuticals (EYPT) Q1 2025 Earnings Call May 07, 2025 08:30 AM ET Company Participants George Elston - Executive VP & CFOJay Duker - President, CEO & DirectorJennifer Kim - Equity Research DirectorRamiro Ribeiro - Chief Medical OfficerKambiz Yazdi - Vice President - Equity ResearchDebanjana Chatterjee - DirectorYigal Nochomovitz - Director Conference Call Participants Tessa Romero - Equity AnalystTyler Van Buren - Managing Director, Senior Biotech Equity Research AnalystYatin Suneja - Senior Ma ...

Financial Data and Key Metrics Changes - For the quarter ended March 31, 2025, total net revenue was $24.5 million compared to $11.7 million for the same quarter in 2024, indicating a significant increase [22] - Operating expenses for the quarter totaled $73.3 million, up from $45 million in the prior year period, primarily due to ongoing Phase III trials for DuraVu [24] - The net loss for the quarter was $45.2 million or $0.65 per share, compared to a net loss of $29.3 million or $0.55 per share for the prior year period [24] Business Line Data and Key Metrics Changes - Net product revenue for the quarter was $700,000, consistent with the previous year, with expectations for immaterial levels going forward as the company will cease supplying YUTIQ to ANI Pharmaceuticals after May 31, 2025 [22] - Net revenue from royalties and collaborations totaled $23.7 million, up from $11 million in the corresponding period in 2024, driven by recognition of deferred revenue from the outlicense of YUTIQ U.S. rights in 2023 [23] Market Data and Key Metrics Changes - The DuraVu program is positioned to address a large unmet need in a growing multibillion-dollar market for retinal diseases, particularly wet AMD and diabetic macular edema (DME) [12][18] - DME represents a $3 billion market opportunity by 2030, with DuraVu uniquely positioned to potentially extend therapeutic dosing intervals compared to current treatment options [18] Company Strategy and Development Direction - The company is focused on advancing DuraVu through late-stage clinical development, with a goal to complete enrollment in the Phase III trials in the second half of 2025 [9][26] - The strategic emphasis is on delivering life-changing treatments for severe retinal diseases, with a commitment to maintaining a strong balance sheet to support clinical milestones [26] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing clinical trials for DuraVu, highlighting strong enrollment rates and positive feedback from physicians and patients [8][9] - The company anticipates completing enrollment in the Phase III trials in the second half of 2025, with top-line data expected in 2026 [26] Other Important Information - The company ended the first quarter with $318.2 million in cash and investments, affirming guidance that this will support operations into 2027 [21] - The manufacturing facility in Northbridge, Massachusetts, is operational and capable of producing over 1 million derivative treatments annually [17] Q&A Session Summary Question: Enrollment completion timeline for Phase III trials - Management reiterated guidance for full enrollment in both trials in the second half of this year, with potential for earlier completion based on current enrollment rates [32] Question: Upcoming FDA meeting regarding DME - The company plans to propose a clinical plan for a Phase III study comparing their drug to standard care, with the primary endpoint being best corrected visual acuity (BCVA) [34] Question: Factors contributing to rapid enrollment in Phase III trials - The rapid enrollment is attributed to the patient-centric study design and robust Phase II data, which instills confidence in investigators and patients [38][41] Question: Screen failure rates and patient mix in trials - The company is performing better than the historical screen failure rate of approximately 50%, with a target mix of 75% treatment-naive and 25% previously treated patients [50][51] Question: Impact of biosimilars on the wet AMD market - Management believes that DuraVu's unique mechanism of action and sustained delivery will differentiate it from biosimilars, which currently represent a small portion of the market [76][80] Question: Potential for rolling NDA submission - The NDA submission will depend on the last patient in the second pivotal trial, with preparations already underway to expedite the submission process [83][85]

Financial Data and Key Metrics Changes - For Q1 2025, total net revenue was $24.5 million, up from $11.7 million in Q1 2024, indicating a significant increase [20] - Net product revenue remained consistent at $700,000 for both Q1 2025 and Q1 2024, with expectations for immaterial levels moving forward due to the cessation of supplying YUTIQ [20] - Operating expenses rose to $73.3 million in Q1 2025 from $45 million in the prior year, primarily due to ongoing Phase III trials for DuraVu [22] - The net loss for Q1 2025 was $45.2 million, or $0.65 per share, compared to a net loss of $29.3 million, or $0.55 per share, in the prior year [22] - Cash and investments at the end of Q1 2025 totaled $318.2 million, down from $371 million at the end of 2024, with guidance indicating this will support operations into 2027 [19][22] Business Line Data and Key Metrics Changes - The focus remains on the DuraVu program, with net revenue from royalties and collaborations increasing to $23.7 million in Q1 2025 from $11 million in Q1 2024, driven by deferred revenue recognition from YUTIQ [21] - DuraVu is positioned as a best-in-class sustained release treatment for wet AMD, with ongoing Phase III trials showing strong enrollment rates [6][12] Market Data and Key Metrics Changes - The market for diabetic macular edema (DME) is projected to be a $3 billion opportunity by 2030, with DuraVu positioned to address this significant unmet need [16] - The company anticipates that DuraVu could become a multibillion-dollar blockbuster franchise in the two largest retinal diseases [17] Company Strategy and Development Direction - The company is committed to advancing DuraVu through late-stage clinical development, with a focus on regulatory and commercial success [7][14] - The strategic plan includes a potential NDA filing and commercial launch, supported by a state-of-the-art manufacturing facility capable of producing over 1 million treatments annually [15][24] - The company aims to differentiate DuraVu from existing anti-VEGF therapies by offering a longer dosing interval and improved patient compliance [11][12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in meeting enrollment timelines for the Phase III trials, with expectations to complete enrollment in the second half of 2025 [6][30] - The positive feedback from the retinal community and the robust clinical data package are seen as key drivers for successful trial outcomes [12][13] - The company remains focused on value creation for shareholders while managing cash resources effectively [27] Other Important Information - The company has established a favorable safety profile for DuraVu, with no related ocular or systemic serious adverse events reported in over 190 patients [10] - The enrollment rates in the ongoing trials significantly exceed those observed in comparable historic trials, indicating strong interest from both patients and physicians [12][13] Q&A Session Summary Question: Enrollment completion timeline for trials - Management reiterated guidance for full enrollment in the second half of the year, with potential for earlier completion based on current enrollment rates [30] Question: Upcoming FDA meeting for DME - The company plans to propose a clinical plan for a Phase III study comparing DuraVu to standard care, with the primary endpoint being best corrected visual acuity [31][34] Question: Factors contributing to rapid enrollment - Rapid enrollment is attributed to the patient-centric study design and robust Phase II data, which instills confidence in investigators and patients [36][37] Question: Potential for Phase II study in RVO - While RVO is considered a significant opportunity, the current focus remains on wet AMD and DME, with potential for future expansion based on Phase III data outcomes [39][40] Question: Screen failure rates and patient mix - The company reported better than historical screen failure rates, with a target mix of approximately 75% treatment-naive patients in the trials [43][44] Question: Impact of biosimilars on the market - Management believes that DuraVu's unique mechanism of action and sustained delivery will mitigate any potential impact from biosimilars in the wet AMD market [67][70] Question: NDA submission strategy - The NDA submission will be dependent on the last patient in for the second trial, with preparations already underway to expedite the process [72][73] Question: Data release timing for trials - Data from the two trials is expected to be released approximately two months apart, based on enrollment patterns [76][77] Question: Patient characteristics in trials - The rationale for patient enrollment criteria is based on FDA guidelines requiring active wet AMD patients, with a focus on those with decreased vision and fluid on OCT [80]