EyePoint Pharmaceuticals (NasdaqGM:EYPT) Conference March 25, 2026 08:45 AM ET Company ParticipantsGeorge O. Elston - EVP and CFOJay S. Duker - President and CEOConference Call ParticipantsLisa Walter - Biotechnology AnalystLisa WalterGood morning, everyone. I'm Lisa Walter, biotech analyst here at RBC Capital Markets. Thanks for joining us at RBC's Ophthalmology Conference. This session, we have Jay Duker, Managing Director and Chief Executive Officer, and George Elston, EVP, and Chief Financial Officer fr ...

Company Overview - EyePoint Pharmaceuticals is a biotechnology company focused on innovative sustained-release drug delivery systems for ocular diseases, particularly chronic and severe retinal conditions [5] - The company generates revenue primarily through product sales and strategic collaborations, with a product pipeline that includes ILUVIEN, YUTIQ, DEXYCU, and EYP-1901 [8] - EyePoint's main customers are healthcare providers and ophthalmologists treating retinal conditions in the United States, China, and the United Kingdom [8] Financial Performance - As of the latest report, EyePoint's market capitalization is $1.1 billion, with a revenue of $31.37 million for the trailing twelve months (TTM) [4] - The company reported a net income loss of approximately $231.96 million (TTM) as it continues to invest heavily in research and development [4][9] - EyePoint ended the year with about $306 million in cash and investments, sufficient to fund operations into late 2027 [9] Recent Developments - Parkman Healthcare Partners disclosed a new position in EyePoint, acquiring 1,088,033 shares in the fourth quarter, which increased the position's value by $19.88 million [2] - EyePoint shares have surged by 93% over the past year, significantly outperforming the S&P 500's 20% gain during the same period [7] - The company is advancing DURAVYU, a sustained-release therapy for serious retinal diseases, with Phase 3 trials currently enrolling over 900 patients and topline data expected in mid-2026 [7] Market Position - EyePoint is positioned to compete in a large ophthalmology market, which is currently dominated by frequent anti-VEGF injections [9] - The company’s differentiated product pipeline and strategic alliances support its leadership in ophthalmic therapeutics [5]

Clinical Trials and Product Development - The fiscal year ended December 31, 2025, was marked by the completion of pivotal Phase 3 clinical trials for DURAVYU, with data expected to begin in mid-2026 [438]. - Enrollment in the pivotal Phase 3 trials for wet AMD was completed on July 29, 2025, with the first patient dosed in the DME program in February 2026 [438]. - DURAVYU demonstrated a +7.1 letter BCVA gain and a 76-micron CST reduction at week 24 in the Phase 2 VERONA clinical trial, with a supplement-free rate of 73% compared to 50% for aflibercept [443]. - DURAVYU's Phase 2 VERONA trial in DME met both primary and secondary endpoints, showing sustained improvement in vision and safety [443]. - The company anticipates the first patient dosing in the Phase 3 COMO and CAPRI trials for DME in the first quarter of 2026 [443]. - The company presented multiple datasets at the ARVO Annual Meeting, highlighting DURAVYU's potential in various retinal disease indications [443]. Financial Performance - Total revenues decreased by $11.9 million, or 28%, to $31.4 million in 2025 compared to $43.3 million in 2024 [457]. - Product sales, net decreased by $1.6 million, or 50%, to $1.6 million in 2025 due to the termination of the ANI commercial supply agreement [458]. - License and collaboration agreement revenues decreased by $21.8 million, or 57%, to $16.7 million in 2025 primarily due to the recognition of remaining deferred revenue [459]. - Royalty income increased by $11.4 million, or 708%, to $13.0 million in 2025, attributed to the recognition of deferred SWK royalty income [460]. - Net loss increased by $101.1 million, or 77%, to $232.0 million in 2025 from $130.9 million in 2024 [457]. Expenses and Cash Flow - Research and development expenses increased by $88.1 million, or 66%, to $221.0 million in 2025, driven by ongoing DURAVYU Phase 3 clinical trials [462]. - Total operating expenses increased by $85.7 million, or 45%, to $274.8 million in 2025 compared to $189.1 million in 2024 [457]. - Operating cash outflows totaled $240.1 million in 2025, primarily due to a net loss of $232.0 million [476]. - Cash, cash equivalents, and investments in marketable securities totaled $306.1 million at December 31, 2025, expected to fund operations into Q4 2027 [472]. Financing Activities - The underwritten public offering of 11,000,000 shares at $12.00 per share raised approximately $162.1 million in net proceeds after underwriting discounts [440]. - The company completed a public offering with gross proceeds of $172.5 million, selling 12,875,000 shares at $12.00 per share [467]. - The company raised $173.4 million from the issuance of 12,875,000 shares of common stock in a follow-on offering in 2025 [480]. - In 2024, the company raised $163.3 million from the issuance of 14,636,363 shares of common stock in a follow-on offering [480]. - Net cash provided by financing activities for the year ended December 31, 2025 totaled $173.7 million, an increase from $164.0 million in 2024 [479]. Corporate Developments - The company completed a buyout of its 3.125% perpetual royalty obligation for a one-time payment of $17.25 million, eliminating future royalty payments starting January 1, 2025 [439]. - The company reached an agreement in principle with the DOJ to settle matters related to its sales practices for approximately $4.7 million plus interest [444]. - The company appointed Michael Campbell as Chief Commercial Officer on February 18, 2026, to strengthen its commercial strategy [443]. - The company does not have any off-balance sheet arrangements that would materially affect its financial condition [479]. - The company is classified as a smaller reporting company and is not required to provide certain market risk disclosures [481].

Core Viewpoint - Eyepoint Pharmaceuticals is making significant progress with its lead retinal candidate DURAVYU, which is expected to provide top-line data in wet age-related macular degeneration (wet AMD) by mid-2026, while also advancing pivotal studies in diabetic macular edema (DME) [3][4][21] Clinical Profile - DURAVYU's differentiation is attributed to its six-month dosing potential via standard in-office intravitreal injection, its delivery technology, and a novel multi-mechanism of action (multi-MOA) that inhibits VEGF, PDGF, and IL-6 via JAK1 without TIE-2 inhibition [1][7] - The clinical program has shown no safety signals across more than 190 patients in completed Phase 1 and Phase 2 trials, with consistent safety profiles in ongoing Phase 3 trials [2][6] Financial Overview - As of year-end 2025, the company reported cash and investments of $306 million, which is expected to fund operations into Q4 2027, despite a decline in revenues and an increase in operating expenses due to Phase 3 activities [5][16] - Total net revenue for Q4 2025 was $0.6 million, down from $11.6 million in the prior year, primarily due to deferred revenue recognition [17] - For the full year 2025, total net revenue was $31 million, compared to $43 million in 2024, with operating expenses rising to $275 million from $189 million [20] Safety Monitoring - The safety profile of DURAVYU includes low intraocular inflammation rates (~1%) and cataract/floaters rates comparable to control, with ongoing internal masked reviews and independent Data Safety Monitoring Committee (DMC) oversight [6][10] - Adverse events reported include cataracts in 5.8% of patients and vitreous floaters in 5.2%, consistent with intravitreal injection studies [9][18] Regulatory and Biomarker Work - The company is conducting two identical Phase 3 wet AMD trials and does not plan to alter its approach regarding regulatory pathways, emphasizing a non-inferiority strategy [11] - Additional biomarker data related to the JAK1 receptor and downstream IL-6 effects will be presented at ARVO in May, with ongoing studies assessing human impact [12] Commercial Readiness - The company is preparing for the launch of DURAVYU, focusing on market positioning, pricing research, and patient access [13] - Eyepoint has a cGMP manufacturing facility in Massachusetts that supports both chemistry, manufacturing, and controls (CMC) submissions for a planned NDA and commercial supply [14] Future Outlook - Near-term priorities include top-line data from the Phase 3 LUGANO wet AMD trial anticipated in mid-2026, with LUCIA data closely following, and completing enrollment in the pivotal Phase 3 DME program in the second half of 2026 [21]

Financial Data and Key Metrics Changes - The company ended 2025 with a strong balance sheet of $306 million in cash and investments, down from $371 million as of December 31, 2024 [17] - Total net revenue for Q4 2025 was $0.6 million, a significant decrease from $11.6 million in Q4 2024, primarily due to the recognition of remaining deferred revenue related to the YUTIQ product rights [15] - For the full year 2025, total net revenue was $31 million, compared to $43 million in 2024, again driven by the deferred revenue recognition [16] - Operating expenses for Q4 2025 totaled $71 million, up from $57 million in the prior year, mainly due to ongoing Phase 3 trials for DURAVYU [16] - The net loss for Q4 2025 was approximately $68 million or $0.81 per share, compared to a net loss of $41 million or $0.64 per share in the prior year [16] Business Line Data and Key Metrics Changes - DURAVYU is on track to deliver top-line data in wet AMD beginning in mid-2026, with the first patients dosed in pivotal Phase 3 DME trials [7][8] - The company is focused on building DURAVYU into a durable franchise targeting the largest retinal disease markets, which have a combined current global market of $10 billion [12] Market Data and Key Metrics Changes - The global market for wet AMD and DME is currently valued at $10 billion and is expected to grow, highlighting the significant commercial potential for DURAVYU [12] Company Strategy and Development Direction - The company aims to position DURAVYU as the first to market among current investigational sustained release programs in both wet AMD and DME, with a potential best-in-class profile [11] - The strategy includes a focus on a de-risked, clinically rigorous, and patient-centric approach to drug development [19] - The company is preparing for a potential U.S. launch of DURAVYU, with a strong emphasis on commercial readiness and operational expansion [12][13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in DURAVYU's blockbuster potential, supported by its compelling clinical profile and favorable safety data [8] - The company is well-capitalized to continue advancing DURAVYU through late-stage development programs, with cash expected to fund operations into Q4 2027 [18] - Management highlighted the importance of upcoming milestones, including reporting top-line data for the Phase 3 LUGANO trial anticipated in mid-2026 [19] Other Important Information - The company welcomed Michael Campbell as the new Chief Commercial Officer, who brings extensive experience in product launches and oversight of ophthalmology franchises [12] - The company is expanding operations at its cGMP manufacturing facility in Massachusetts, which supports both NDA submissions and commercial supply [13] Q&A Session Summary Question: Can you clarify the rate of ocular AEs seen with DURAVYU, particularly around vitreous floaters and cataracts? - The incidence of cataracts in treated patients was 5.8%, while vitreous floaters were reported in 5.2% of patients, consistent with expectations for injection studies [24][26] Question: How are you thinking about recent FDA chatter around single study-driven regulatory approvals? - The company welcomes a more rapid pathway to drug approvals but does not anticipate changing its strategy for current trials [32][34] Question: Will there be additional looks at masked safety in the wet AMD trials before they read out? - The company has ongoing internal and independent Data Safety Monitoring Committee reviews, with the next meeting scheduled for May [39] Question: What is the expected safety profile in LUGANO LUCIA compared to DAVIO 2? - The company does not expect significant differences in safety profiles, as the insert design and drug dosage have been optimized [75][78] Question: How do you expect the steps or requirements to affect the adoption of vorolanib? - Initial adoption is expected among patients requiring frequent treatments, with broader adoption possible if clinical trials demonstrate superior efficacy [91][94]

Financial Data and Key Metrics Changes - The company ended 2025 with a strong balance sheet of $306 million in cash and investments, down from $371 million as of December 31, 2024 [17] - For Q4 2025, total net revenue was $0.6 million, a significant decrease from $11.6 million in Q4 2024, primarily due to the recognition of remaining deferred revenue related to the YUTIQ product rights [15] - Full year 2025 total net revenue was $31 million, compared to $43 million in 2024, again driven by the deferred revenue recognition [16] - Operating expenses for Q4 2025 totaled $71 million, up from $57 million in the prior year, mainly due to ongoing Phase III trials for DURAVYU [16] - The net loss for Q4 2025 was approximately $68 million or $0.81 per share, compared to a net loss of $41 million or $0.64 per share in the prior year [16] Business Line Data and Key Metrics Changes - DURAVYU is on track to deliver top-line data in wet AMD beginning in mid-2026, with the first patients dosed in pivotal Phase III DME trials [7][8] - The company is focused on building DURAVYU into a durable franchise targeting the largest retinal disease markets, which have a combined current global market of $10 billion [12] Market Data and Key Metrics Changes - The global market for wet AMD and DME is currently valued at $10 billion and is expected to grow [12] Company Strategy and Development Direction - The company aims to position DURAVYU as the first to market among current investigational sustained release programs in both wet AMD and DME, with a potential best-in-class profile [11] - The strategy includes a focus on commercial readiness and the appointment of a new Chief Commercial Officer to prepare for a successful U.S. launch [12][13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in DURAVYU's blockbuster potential, citing its compelling clinical profile and favorable safety profile observed in over 190 patients across four completed clinical trials [8][9] - The company is well-capitalized to continue advancing DURAVYU through late-stage development programs, with cash expected to fund operations into Q4 2027 [18] Other Important Information - The company is preparing for regulatory submission and pre-approval inspection as it nears NDA submission for DURAVYU [13] Q&A Session Summary Question: Can you clarify the rate of ocular AEs seen with DURAVYU, particularly around vitreous floaters and cataracts? - The incidence of cataracts in treated patients was 5.8%, while vitreous floaters were reported in 5.2% of patients, consistent with expectations for injection studies [24][26] Question: How are you thinking about recent FDA chatter around single study-driven regulatory approvals? - The company welcomes a more rapid pathway to drug approvals but does not anticipate changing its strategy for current trials [32] Question: Will there be additional looks at masked safety in the wet AMD trials before they read out? - There will be ongoing safety monitoring by both internal and independent committees, with the next review scheduled for May [39] Question: What are the expectations for the reduction in treatment burden in the wet AMD studies? - The treatment burden will be measured after the loading doses, with expectations of a 60% reduction in the DURAVYU arm compared to the control arm [69] Question: How do you expect the steps or requirements to affect the adoption of vorolanib? - Initial adoption is expected among patients requiring frequent treatments, with potential expansion based on clinical trial outcomes [92]

Financial Data and Key Metrics Changes - For Q4 2025, total net revenue was $0.6 million, a decrease from $11.6 million in Q4 2024, primarily due to the recognition of remaining deferred revenue related to the YUTIQ product rights license [14][15] - Full year 2025 total net revenue was $31 million, down from $43 million in 2024, again attributed to the deferred revenue recognition [16][17] - Operating expenses for Q4 2025 totaled $71 million, up from $57 million in the prior year, driven by ongoing Phase 3 trials for DURAVYU [16] - Full year operating expenses reached $275 million, compared to $189 million in 2024, reflecting increased trial costs [17] - Net loss for Q4 2025 was approximately $68 million or $0.81 per share, compared to a net loss of $41 million or $0.64 per share in Q4 2024 [16] - Full year net loss was $232 million or $3.17 per share, compared to a net loss of $131 million or $2.32 per share in 2024 [17] - Cash and investments as of December 31, 2025, totaled $306 million, down from $371 million at the end of 2024, expected to fund operations into Q4 2027 [17][18] Business Line Data and Key Metrics Changes - DURAVYU is positioned as a leading asset with pivotal Phase 3 trials for wet AMD and DME, with first patient dosing reported [5][10] - The company anticipates top-line data for the wet AMD program in mid-2026 and for the DME program in the second half of 2027 [10][19] Market Data and Key Metrics Changes - The combined global market for wet AMD and DME is estimated at $10 billion and growing, representing a significant opportunity for DURAVYU [11] Company Strategy and Development Direction - The company aims to establish DURAVYU as a durable franchise targeting the largest retinal disease markets, focusing on its unique multi-mechanism of action and favorable safety profile [10][11] - The strategy includes preparing for a potential U.S. launch and expanding commercial readiness with the appointment of a new Chief Commercial Officer [11][12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in DURAVYU's potential, citing strong clinical data and a favorable safety profile, with no safety signals reported in over 190 patients across completed trials [6][27] - The company is optimistic about upcoming milestones and the transformative potential of DURAVYU in the retinal disease market [13][19] Other Important Information - The company is expanding its cGMP manufacturing facility to support commercial supply and regulatory submissions [12] - Management emphasized the importance of a de-risked, clinically rigorous, and patient-centric approach in advancing DURAVYU [19] Q&A Session Summary Question: Can you clarify the rate of ocular AEs seen with DURAVYU, particularly around vitreous floaters and cataracts? - The incidence of cataracts in treated patients was 5.8%, with vitreous floaters reported at 5.2%, consistent with injection studies [25][26] Question: How are you thinking about recent FDA chatter around single study-driven regulatory approvals? - The company welcomes a more rapid approval pathway but does not anticipate altering its current strategy for wet AMD and DME [31][32] Question: Will there be additional looks at masked safety in the wet AMD trials before they read out? - There will be ongoing safety reviews by both internal and independent committees, with the next review scheduled for May [39] Question: What are the expectations for the reduction in treatment burden in the wet AMD studies? - The treatment burden will be measured after the loading doses, with expectations of a 60% reduction in the DURAVYU arm compared to the control [68][70] Question: How do you expect the steps or requirements to affect the adoption of vorolanib? - Initial adoption is expected among patients requiring frequent treatments, with potential expansion based on clinical trial outcomes [90][92]

Core Viewpoint - EyePoint (EYPT) reported a quarterly loss of $0.81 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.78, marking an earnings surprise of -3.85% [1] - The company has not surpassed consensus EPS estimates over the last four quarters, with revenues of $0.62 million for the quarter ended December 2025, exceeding the Zacks Consensus Estimate by 15.89% [2] Financial Performance - The loss per share increased from $0.64 a year ago to $0.81 this quarter, indicating a decline in performance [1] - Year-over-year revenues decreased significantly from $11.59 million to $0.62 million [2] Market Position - EyePoint shares have increased by approximately 0.3% since the beginning of the year, while the S&P 500 has declined by 0.4% [3] - The company currently holds a Zacks Rank 2 (Buy), suggesting it is expected to outperform the market in the near future [6] Future Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.70 on revenues of $0.3 million, and for the current fiscal year, it is -$2.91 on revenues of $1.8 million [7] - The Medical - Biomedical and Genetics industry is ranked in the bottom 44% of over 250 Zacks industries, which may impact EyePoint's stock performance [8]

Core Insights - EyePoint, Inc. is advancing its pivotal Phase 3 trials for DURAVYU in wet age-related macular degeneration (AMD) and diabetic macular edema (DME), with data readouts expected to begin in mid-2026 [1][2] - The company has appointed Michael Campbell as Chief Commercial Officer to lead the launch strategy for DURAVYU [1] - As of December 31, 2025, EyePoint reported over $300 million in cash and investments, providing financial stability into Q4 2027 [1][12] Clinical Development - DURAVYU is currently in two identical Phase 3 trials, LUGANO and LUCIA, for wet AMD, with over 900 patients enrolled [4] - The trials are designed to follow a non-inferiority pathway with an on-label aflibercept control arm and six-month re-dosing [4] - Interim safety data from the trials has shown a consistent favorable safety profile [4] - The first patients have been dosed in the COMO and CAPRI Phase 3 trials for DME, with rapid enrollment expected [4] Financial Performance - For Q4 2025, total net revenue was $0.6 million, a significant decrease from $11.6 million in Q4 2024 [6] - Net product revenue for Q4 2025 was $0.3 million, down from $0.8 million in the same period of 2024 [6] - Total net revenue for the full year 2025 was $31.4 million, compared to $43.3 million in 2024 [9] - Operating expenses for Q4 2025 totaled $71.0 million, up from $56.8 million in the prior year, primarily due to ongoing Phase 3 trials [8][11] Corporate Developments - EyePoint has expanded its intellectual property protection for DURAVYU with a new U.S. patent expected to extend coverage into 2043 [10] - The company completed manufacturing of registration batches for DURAVYU, which will support the New Drug Application (NDA) filing [10] - An underwritten public offering in October 2025 raised gross proceeds of $172.5 million [10]

Summary of EyePoint Pharmaceuticals FY Conference Call Company Overview - **Company**: EyePoint Pharmaceuticals (NasdaqGM:EYPT) - **Industry**: Biotechnology, specifically focusing on ophthalmology and treatments for retinal diseases Key Highlights - **Phase 3 Trials Initiation**: EyePoint announced the dosing of patients in both phase 3 diabetic macular edema (DME) trials, COMO and CAPRI, achieving their timeline goal of first patient dosing in Q1 2026 [2][3] - **Market Opportunity**: The DME market is projected to reach $3 billion annually in the U.S. EyePoint aims to capture a significant share of this market with their sustained release TKI, DURAVYU, which is unique in the DME space [2][3] - **Trial Design**: Each DME trial will enroll approximately 240 patients, leveraging safety data from previous wet AMD trials to maintain a lower patient count while ensuring robust results [3][5] Core Points and Arguments - **Efficacy and Safety**: DURAVYU demonstrated superior results compared to EYLEA in phase 2 trials, with patients showing better visual acuity and less fluid accumulation [4][21] - **Recruitment Success**: The company successfully recruited for their wet AMD trials in about 7 months, indicating strong interest and confidence from clinical sites, which will also be utilized for the DME trials [5][6] - **Safety Profile**: No serious adverse events (SAEs) have been reported in the 191 patients treated across four trials, reinforcing confidence in the safety of DURAVYU [22] Mechanistic Insights - **IL-6 Blockade Discovery**: EyePoint identified that DURAVYU acts as a potent blocker of JAK1, which is linked to IL-6 activity, potentially providing additional therapeutic benefits in treating DME and wet AMD [15][19] - **Differentiation from Competitors**: EyePoint's approach combines anti-VEGF and anti-IL-6 mechanisms, which may offer advantages over existing treatments [19][60] Phase 3 Expectations - **Non-Inferiority and Treatment Burden**: The primary endpoint for phase 3 trials is non-inferiority to EYLEA, with a secondary focus on reducing treatment burden. A 60% reduction in treatment burden is anticipated compared to EYLEA's regimen [28][29] - **Supplementation Criteria**: Improved criteria for supplemental injections are expected to lead to fewer unnecessary supplements in the phase 3 trials, enhancing overall treatment efficiency [32][33] Market Potential - **Combined Market Size**: The total market opportunity for wet AMD and DME is estimated at $15 billion globally, with EyePoint targeting a significant share if they can demonstrate non-inferiority and additional benefits [68] - **Long-term Patient Compliance**: The sustained release nature of DURAVYU is expected to improve patient compliance and outcomes, addressing a critical issue in chronic disease management [49][50] Additional Insights - **Regulatory Strategy**: EyePoint is preparing for potential NDA submissions following the completion of their trials, with expectations of a streamlined process due to the identical nature of the studies [38][39] - **Future Developments**: The company plans to present more data at upcoming conferences, which may further validate their findings and enhance market perception [19][68] This summary encapsulates the key points discussed during the conference call, highlighting EyePoint Pharmaceuticals' strategic direction, market potential, and innovative approaches in the treatment of retinal diseases.