Ocular Therapeutix (NasdaqGM:OCUL) 2025 Conference September 09, 2025 12:50 PM ET Company ParticipantsPravin Dugel - Executive Chairman, President & CEOConference Call ParticipantsColleen Kusy - Senior Research AnalystColleen KusyGood afternoon, everyone. Thanks for being with us for the Baird Global Healthcare Conference. My name is Colleen Cousy. I'm one of the Senior Analysts covering biotech, and I'm very pleased to have with us today Ocular Therapeutix, including Dr. Pravin U. Dugel, President, CEO, an ...

Question-and-Answer SessionI hear it's just over a year that you've been at the company. Perhaps you could give us a little bit of background and what attracted you to Ocular.Pravin DugelExecutive Chairman, President & CEO Well, it's been a year, but it seems like it's been a dozen years, but you're right, it's been a year. Well, look, I was very happily retired after my last company. And I think what I had no intention at all of getting another job, although I love my time at Iveric Bio. I think there was ...

Summary of Ocular Therapeutix FY Conference Call (September 08, 2025) Company Overview - **Company**: Ocular Therapeutix (NasdaqGM: OCUL) - **Lead Product**: AXPAXLI™ - **Technology**: ELUTYX™ technology, a long-acting platform for drug delivery Core Industry Insights - **Market Addressed**: Wet age-related macular degeneration (AMD) - **Patient Dropout Rate**: 40% of patients discontinue treatment within the first year, leading to potential blindness for many [6][6] - **Clinical Need**: A more durable treatment option is essential to improve patient outcomes and reduce dropout rates [6][6] Key Clinical Programs - **AXPAXLI™**: A TKI in a tunable hydrogel aimed at improving treatment sustainability and long-term outcomes for wet AMD patients [6][6][8] - **Clinical Trials**: - **SOL1**: A Phase 3 superiority trial expected to read out in Q1 2026, focusing on maintaining vision [12][21] - **SOLAR**: A Phase 3 non-inferiority trial against EYLEA® expected to read out in H1 2027 [12][21] - **Open-label Extension**: Dosing every six months, focusing on crossover patients to demonstrate the benefits of starting treatment with AXPAXLI™ [12][13] Regulatory Pathway - **Special Protocol Assessment (SPA)**: Received for SOL1, indicating a clear regulatory path following FDA guidelines [4][16] - **Superiority Label**: AXPAXLI™ aims to be the first and only drug with a superiority label in its field, potentially immune from pricing pressures and step therapy [13][18] Trial Design and Patient Selection - **Patient Selection**: Focused on treatment-naive patients with good vision and no fibrosis or atrophy, ensuring a robust study population [27][28] - **Trial Design**: Unique approach with two complementary trials providing comprehensive data on drug efficacy and safety [30][32] Future Opportunities - **Diabetic Retinopathy and Diabetic Macular Edema**: Positive results from the Helios safety study indicate a significant opportunity in these areas, with plans for further trials [56][61] - **Global Market Potential**: The drug is expected to have a broad global market, with ongoing discussions for regulatory approvals outside the U.S. [46][47] Commercialization Strategy - **Manufacturing and Sales Team**: Ocular Therapeutix is scaling up manufacturing and leveraging an experienced commercial team from its existing product, DEXTENZA® [54][55] - **Market Readiness**: The company is preparing for commercialization in the U.S. and has plans for European market entry [54][46] Additional Insights - **Long-term Vision**: The company aims to provide a reliable treatment schedule for patients, potentially moving towards a fixed six-month treatment regimen [51][52] - **Investor Engagement**: An upcoming investor day is expected to provide further insights and updates on clinical programs and market strategies [71][71] This summary encapsulates the key points discussed during the Ocular Therapeutix FY Conference Call, highlighting the company's strategic direction, clinical programs, and market opportunities.

Company to highlight ongoing AXPAXLI™ wet AMD registrational program, strategy and next steps in NPDR and DME, and global commercial opportunity for AXPAXLI Event to feature global retinal disease experts Dr. Arshad M. Khanani MD, MA, FASRS; Professor Adnan Tufail, MBBS, MD, FRCOphth; Dr. Eleonora Lad, MD, PhD; and Dr. Patricio G. Schlottmann, MD The live event will take place in New York City on September 30, 2025, at 2:00 PM ET BEDFORD, Mass., Sept. 08, 2025 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (N ...

Group 1 - The article discusses Stephen's background as a Registered Nurse (RN) and an MBA, highlighting his unique approach to analyzing healthcare and tech stocks through the "Dizzy Framework" [1] - The "Dizzy Framework" is designed to mitigate common behavioral errors in investing, such as reacting to market noise or adhering too rigidly to prior beliefs [1] - The framework emphasizes the importance of quality and timing of information, promoting a patient and disciplined investment strategy that translates complex scientific and market dynamics into actionable investment theses [1] Group 2 - Influences on Stephen's investment analysis include concepts from "Superforecasting" and "Fooled by Randomness," which inform his probabilistic approach to market predictions [1]

BEDFORD, Mass., Aug. 27, 2025 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”), an integrated biopharmaceutical company committed to redefining the retina experience, today announced participation in several upcoming investor and scientific conferences in September 2025. Upcoming Investor Conferences Morgan Stanley 23rd Annual Global Healthcare Conference:Fireside Chat Date/Time: Monday, September 8, 2025Fireside Chat Time: 2:35 – 3:10 PM ETPresenter: Pravin U. Dugel, MD, Executive Chai ...

"At least half of all diabetic patients are expected to develop some form of diabetic retinopathy in their lifetime," added David M. Brown, MD, Chief Medical Officer of Retina Consultants of America (RCA). "With 6.4 million Americans currently living with NPDR alone, the disease burden is staggering, yet fewer than 1% of these patients are treated. This unfortunate dynamic is despite the proven efficacy of anti-VEGFs and is driven primarily by the challenges of ongoing intraocular injections in an asymptoma ...

Core Viewpoint - Ocular Therapeutix reported a significant widening of net loss in Q2 2025 due to increased research and marketing investments, alongside a decline in commercial revenue from its only marketed product, DEXTENZA [1][5][6] Financial Performance - Revenue (GAAP) for Q2 2025 was $13.5 million, slightly above expectations of $13.46 million, but down 18.1% from $16.4 million in Q2 2024 [2][5] - Net loss per share (GAAP) was $(0.39), missing analyst estimates by 8.4% and representing a 50% increase from $(0.26) in Q2 2024 [2][5] - Research and Development (R&D) expenses rose 76.9% to $51.1 million, driven by costs associated with two major Phase 3 trials [2][6] - Selling and Marketing expenses increased 37% to $13.7 million, reflecting pre-commercialization activities for AXPAXLI [2][6] - Cash and cash equivalents stood at $391.1 million as of June 30, 2025, with management indicating this provides a runway into 2028 [2][9] Product and Market Overview - DEXTENZA, the company's FDA-approved ocular implant, faced reimbursement challenges, leading to an 18.1% decline in net revenue despite a 5% increase in unit sales [5][8] - The company is focusing on advancing late-stage clinical trials for AXPAXLI, an ocular implant targeting wet age-related macular degeneration (AMD) [4][7] Clinical Development - The SOL-1 and SOL-R trials for AXPAXLI are progressing on schedule, with topline data from SOL-1 expected in Q1 2026 and primary endpoint data from SOL-R anticipated in the first half of 2027 [7] - Positive feedback was received from the FDA regarding potential designs for future studies in non-proliferative diabetic retinopathy (NPDR) and diabetic macular edema (DME) [7] Strategic Focus and Future Outlook - The company did not provide specific financial guidance for the upcoming quarter but emphasized the importance of advancing AXPAXLI's pivotal trials and maintaining cash reserves [10][11] - Future performance will depend on managing DEXTENZA's reimbursement pressures and executing late-stage clinical programs [11]

Ocular Therapeutix (OCUL) came out with a quarterly loss of $0.39 per share versus the Zacks Consensus Estimate of a loss of $0.35. This compares to a loss of $0.24 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -11.43%. A quarter ago, it was expected that this biotechnology company would post a loss of $0.29 per share when it actually produced a loss of $0.37, delivering a surprise of -27.59%. Over the last four quarters, t ...

Financial Data and Key Metrics Changes - The company ended the second quarter with over $390 million in cash and cash equivalents, having raised approximately $97 million through its existing at-the-market facility [28][29] - The company expects a financial runway into 2028, which is well beyond anticipated top-line data readouts for both SOLO-one and SOLAR [29][34] Business Line Data and Key Metrics Changes - The registrational program for expaxly includes the SOLO-one and SOLAR studies, which are designed to address key questions regarding durability and flexibility in treating wet AMD [7][21] - The company reported exceptional retention rates in both SOLO-one and SOLAR trials, reinforcing confidence in the quality of data being generated [31] Market Data and Key Metrics Changes - The company aims to address the critical needs of millions of patients worldwide suffering from wet AMD, where nearly 40% of patients in the U.S. discontinue treatment within the first year [6][30] - The company is preparing to expand its reach towards diabetic eye diseases, having received positive FDA feedback on its proposed trial design for patients with diabetic retinopathy [25][34] Company Strategy and Development Direction - The company is focused on advancing expaxly as a treatment designed to offer best-in-class durability and meaningful efficacy, with the potential to be the first product for wet AMD with a superiority claim [7][30] - Plans include incorporating a long-term open-label extension study for both SOLO trials to generate valuable real-world insights and long-term safety data [15][31] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing trials and the potential for expaxly to redefine treatment standards in retinal diseases, particularly in wet AMD and diabetic eye diseases [30][34] - The company is committed to delivering a long-lasting, flexible, and non-pulsatile solution that could improve long-term visual outcomes for patients [16][34] Other Important Information - The company will host an Investor Day on September 30 in New York City to provide deeper insights into the SOLO trials and its diabetic eye disease strategy [27][34] - The company has strategically modified the rescue criteria for the SOLAR trial to enhance its clinical relevance and adoption potential [19][20] Q&A Session Summary Question: When do you expect to complete randomization of the 555 patients required for the SOLAR trial? - Management stated that enrollment has been completed and trial conduct is going superbly [38] Question: What drove the change in the rescue criteria for the SOLAR study? - The change was made purely for strategic advantage and was not required by the FDA, reflecting confidence based on the data observed [39][40] Question: How do you think removing the 10-letter loss requirement for the rescue criteria will impact the primary endpoint? - Management confirmed that the modification will not impact the primary endpoint and is aimed at making the drug more adoptable [50][56] Question: What is the rationale for starting the open-label extensions now? - The decision was based on logistics and the desire to answer clinically relevant questions regarding the drug's long-term benefits [99] Question: How should investors think about the interplay of the eventual time to market for expaxly with a potential superior label? - Management emphasized that a superiority label would provide a significant competitive advantage, allowing for better patient care and outcomes [96][97]