SOL-1, Ocular's first registrational trial in wet AMD, completed randomization in December 2024 and retention remains exceptional as the trial continues on track for top-line readout in 1Q 2026 These two complementary trials are intended to form the basis of an NDA submission of AXPAXLI in wet AMD BEDFORD, Mass., May 28, 2025 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, "Ocular"), a fully-integrated biopharmaceutical company committed to redefining the retina experience, today announced that ...

Summary of Ocular Therapeutix (OCUL) Conference Call Company Overview - **Company**: Ocular Therapeutix (OCUL) - **Event**: 2025 Conference on May 27, 2025 - **Key Speaker**: Praveen Dugal, Executive Chairman, President, and CEO Core Industry Insights - **Industry**: Ophthalmology, specifically focusing on treatments for retinal diseases - **Market Context**: The anti-VEGF (vascular endothelial growth factor) market has been established for over 20 years, with ongoing unmet needs for longer-duration treatments [7][10] Key Points and Arguments 1. **Need for Innovation**: There is a significant need for improved treatment options in the anti-VEGF market, as nearly 40% of patients drop out of treatment within the first year due to the unsustainability of frequent injections [10][11] 2. **Product Technology**: Ocular Therapeutix's product, ex-Paxley, is a tunable, completely dissolvable hydrogel that has shown to be safe and efficacious based on consistent data [4][5] 3. **Regulatory Pathway**: The company has a clear regulatory path forward, having received Special Protocol Assessment (SPA) from the FDA for their studies, which aligns with the latest FDA guidelines [5][40] 4. **Treatment Paradigm Shift**: ex-Paxley is positioned to potentially replace existing anti-VEGF treatments as a first-line agent due to its efficacy and the ability to provide longer-lasting results [22][23] 5. **Patient Selection**: The company emphasizes the importance of proper patient selection in clinical trials, aiming to identify patients who will benefit most from the treatment [30][31] 6. **Study Design**: The company has designed two complementary studies (SOLAR and SOLA-one) to gather comprehensive data, with a focus on patient stability and response to treatment [44][45] 7. **Market Opportunity**: The market for retinal disease treatments is vast, and Ocular Therapeutix is confident in its ability to capture significant market share due to its innovative product and strong regulatory support [60] Additional Important Insights - **Retention Rates**: The company has reported unprecedented patient retention rates in their studies, which they attribute to the quality of patient selection and the nature of the treatment [54] - **Regulatory Collaboration**: Ocular Therapeutix has established a strong collaborative relationship with the FDA, which has facilitated a smoother regulatory process for their studies [50] - **Future Outlook**: The company is optimistic about the future of ex-Paxley and its potential to dominate the market once the macroeconomic environment stabilizes [59][60] This summary encapsulates the critical insights and developments discussed during the conference call, highlighting Ocular Therapeutix's strategic positioning within the ophthalmology industry and its innovative approach to addressing unmet patient needs.

Financial Data and Key Metrics Changes - The company has indicated that it is capitalized into 2028, which supports ongoing pivotal trials [50] - The company has not disclosed specific financial metrics in this call, focusing instead on trial progress and strategic direction Business Line Data and Key Metrics Changes - The SOLO-one trial has completed randomization, with top-line data expected in the first quarter of 2026 [13] - The SOAR trial is primarily enrolling treatment-naive patients, with a small allowance for previously treated patients under specific conditions [20] Market Data and Key Metrics Changes - The company believes there is a significant market opportunity in wet AMD, with a high patient dropout rate indicating that the current market is underestimated [52] - The company is positioned to commercialize its product globally, leveraging a mature commercial team and extensive market knowledge [53] Company Strategy and Development Direction - The company aims to maximize drug exposure and potentially achieve a superior label with dosing flexibility [12] - There is a clear path forward for diabetic retinopathy and diabetic macular edema, with plans to proceed when the macro environment stabilizes [44][45] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the FDA's support and the trial designs, indicating that complementary studies are favored [29] - The company is optimistic about the market prospects for its drug, emphasizing that better drugs tend to dominate the market regardless of minor differences in treatment duration [34][35] Other Important Information - The company has robust patent protection for its drug and hydrogel, with patents running until 2041 and pending methods extending to 2044 [49] - The management highlighted the importance of patient retention and the quality of enrolled patients in ongoing trials [8] Q&A Session Summary Question: Is SOAR currently enrolling both treatment naive and treatment experienced patients? - The trial is primarily for treatment-naive patients, with a small allowance for previously treated patients under specific documentation [20] Question: Based on existing clinical data, what percentage of patients do you expect in the SOLAR trial to remain rescue-free during the six months period after expecimen treatment? - The expectation is that if the drug lasts for nine months in one study, it should have a high chance of lasting for six months in another study [24] Question: How likely do you think the FDA will require a second SOAR trial? - Management does not foresee a need for a second trial, citing FDA feedback and existing agreements [29] Question: Do you believe that the first drug on the market with a six-month treatment duration for wet AMD could have a significant advantage in terms of market prospects? - Management emphasized that the better drug always wins, and they are entering the market with a significantly longer treatment duration [34][35] Question: What’s your development plan for diabetic retinopathy? - The company plans to proceed with development when the macro environment stabilizes, as there is no competition in this area [44][45] Question: Is expressly protected by any issued patents? - Yes, the drug and hydrogel are protected by patents, with comprehensive coverage of the process and materials [49]

Ocular Therapeutix (OCUL) 2025 Conference May 20, 2025 02:35 PM ET Speaker0 Capital Markets and it is our great privilege to have Ocular Therapeutics joining us for a fireside chat. Representing the company we have Praveen Dugal, Executive Chair, President, and CEO. Praveen, thanks so much for joining us. How are you doing today? Speaker1 Great, Lisa, and thank you. Thank you for having us on this great conference. An honor to be here, and thank you for the invitation. Speaker0 Excellent. Well, Praveen, jus ...

Summary of Ocular Therapeutix (OCUL) Conference Call Company Overview - **Company**: Ocular Therapeutix (OCUL) - **Product**: ExPaxly, a treatment for wet age-related macular degeneration (AMD) Key Industry Insights - **Regulatory Environment**: The FDA remains consistent and collaborative, with no recent changes affecting timelines or processes [3][4][5] - **Market Context**: The wet AMD market is crowded with existing treatments, including recent generic launches [6] Core Product Differentiation - **ExPaxly's Unique Selling Proposition**: - Aims to address the high dropout rate of 40% in current treatments, which leads to significant patient blindness [11][52] - Offers less frequent dosing, potentially every six to twelve months, compared to current treatments requiring monthly or bi-monthly visits [13][58] - Focuses on sustainability and better long-term outcomes by providing a constant drug delivery, reducing the risk of fibrosis and atrophy [19][18] Clinical Trials - **Current Trials**: - **SOUL-one**: A superiority trial designed to select patients with high VEGF receptor levels [21][25] - **SOLAR**: A non-inferiority trial aimed at ensuring stability in patient responses [21][26] - **Trial Design**: - Both trials are complementary, allowing for a comprehensive understanding of ExPaxly's efficacy and safety [22][28] - The trials have been designed to maximize patient retention and minimize dropout rates [29][44] Regulatory Strategy - **SPA (Special Protocol Assessment)**: The company has maintained its SPA with the FDA, allowing for an extended study period to gather more safety data [44][48] - **Amendments**: Recent amendments to the trials have reduced the number of patients needed for SOLAR, expediting the process while maintaining compliance with FDA guidelines [45][47] Market Potential and Economic Impact - **Patient Retention**: A reduction in dropout rates could lead to significant cost savings for the healthcare system, with estimates of preventing a quarter million patients from going blind [53][60] - **Future Indications**: Plans to expand into non-proliferative diabetic retinopathy and diabetic macular edema, leveraging the efficacy of ExPaxly in these conditions [60][62] Conclusion - **Company's Focus**: Ocular Therapeutix is laser-focused on the success of its clinical trials for ExPaxly, with a strong emphasis on maximizing shareholder value and ensuring a positive impact on patient care [61][64]

Ocular Therapeutix (OCUL) 2025 Conference May 07, 2025 09:00 AM ET Speaker0 One of the Citizens Life Science Conference for 2025. My name is John Walden, analyst here, and pleased to be kicking off with Ocular Therapeutix, a name we've been covering for quite some time. CEO Praveen Duval joining us, And we're just gonna have a a light discussion here. We'll save some time for q and a at the end from the audience. But hopefully, something that we can all learn a little bit because this is a very exciting tim ...

Ocular Therapeutix (OCUL) came out with a quarterly loss of $0.37 per share versus the Zacks Consensus Estimate of a loss of $0.29. This compares to 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 -27.59%. A quarter ago, it was expected that this biotechnology company would post a loss of $0.24 per share when it actually produced a loss of $0.29, delivering a surprise of -20.83%.Over the last four quarters, the c ...

Clinical Trials and Regulatory Outlook - AXPAXLI is currently in two Phase 3 clinical trials for wet AMD, with the SOL-1 trial having randomized 344 subjects as of December 2024[101][102]. - The SOL-1 trial aims to assess the safety and efficacy of AXPAXLI compared to aflibercept, with a primary endpoint of maintaining visual acuity at Week 36[101][106]. - The SOL-R trial, initiated in June 2024, plans to enroll approximately 555 subjects and has a primary endpoint of non-inferiority in mean change in BCVA at Week 56[107][109]. - The FDA agreed that the SOL-R trial should support a potential NDA for AXPAXLI, indicating a favorable regulatory outlook[108]. - The company plans to submit an NDA for AXPAXLI for wet AMD if favorable results are obtained from the SOL-1 and SOL-R trials[109]. - The company is actively planning next steps for AXPAXLI in treating NPDR and DME following positive FDA feedback on trial design[110]. Financial Performance - DEXTENZA's net product revenue for Q1 2025 was $10.6 million, a decrease of $4.1 million or 27.7% compared to Q1 2024, attributed to pricing strategy impacts[113]. - Product revenue decreased to $10.6 million for the three months ended March 31, 2025, down from $14.7 million in the same period of 2024, reflecting a decline of $4.1 million year-over-year[135]. - The company reported a net loss of $64.1 million for the three months ended March 31, 2025, compared to a net loss of $64.8 million in the same period of 2024, an improvement of $0.8 million[134]. - The company incurred net losses of $64.1 million for the three months ended March 31, 2025, and accumulated a deficit of $955.1 million as of the same date[158][159]. - Cash used in operating activities was $44.7 million for the three months ended March 31, 2025, primarily due to operating expenses of $74.6 million[168]. Expenses and Cost Management - Research and development expenses increased significantly to $42.9 million for the three months ended March 31, 2025, compared to $20.7 million in 2024, marking an increase of $22.1 million[139]. - Selling and marketing expenses rose to $14.1 million for the three months ended March 31, 2025, up from $10.2 million in 2024, an increase of $3.9 million[144]. - General and administrative expenses increased to $16.3 million for the three months ended March 31, 2025, compared to $14.1 million in 2024, reflecting a rise of $2.2 million[146]. - The company anticipates that research and development expenses will continue to increase significantly for the remainder of 2025 and beyond as it progresses with ongoing clinical trials[142]. Cash and Financing - As of March 31, 2025, the company had cash and cash equivalents of $349.7 million and outstanding notes payable of $82.5 million under the Barings Credit Facility[154]. - The company plans to fund future capital requirements through equity offerings, debt financings, and collaborations, with no committed external sources of funds currently available[165]. - The company reported a net cash increase of $287.1 million for the three months ended March 31, 2024, primarily from financing activities[171]. - The company has total contractual obligations of $91.0 million, including $82.5 million under the Barings Credit Agreement[173]. - The company has a secured term loan facility with a principal amount of $82.5 million under a credit and security agreement with Barings Finance LLC as of March 31, 2025[187]. Market and Sales Performance - In-Market Sales of DEXTENZA were approximately 40,000 units in Q1 2025, a slight decrease of about 1,000 units from Q1 2024[114]. - The total gross-to-net provisions for DEXTENZA product sales were 49.4% for the three months ended March 31, 2025, compared to 36.1% in 2024[136]. - The company aims to commercialize DEXTENZA in the United States while expanding its operational and management systems[163]. Other Financial Considerations - Interest income was $3.8 million for the three months ended March 31, 2025, down from $3.9 million in 2024, a decrease of $0.1 million[149]. - Interest expense decreased to $3.0 million for the three months ended March 31, 2025, from $4.1 million in 2024, a reduction of $1.1 million[150]. - The Royalty Fee Derivative Liability was valued at $13.9 million as of March 31, 2025[188]. - The company is obligated to pay Incept a royalty equal to a low-single-digit percentage of net sales for Licensed Products in the Ophthalmic Field of Use[178]. - The company is also obligated to pay a mid-single-digit percentage royalty for Licensed Products in the Additional Field of Use[178]. - The company has no off-balance sheet arrangements as defined by the SEC regulations[179]. - An immediate 100 basis point change in interest rates would not have a material effect on the fair market value of the company's investment portfolio[185]. - The company evaluates its estimates and judgments related to revenue recognition and accrued research and development expenses on an ongoing basis[183]. - The company does not enter into financial instruments for trading or speculative purposes[186]. - Changes in the fair value of the Royalty Fee Derivative Liability have no impact on anticipated cash outflows related to this liability[188].

Financial Performance - Total net revenue for Q1 2025 was $10.7 million, a decrease of 27.6% compared to $14.8 million in Q1 2024, primarily due to reduced gross revenues from DEXTENZA sales[5] - Net product revenue was $10.6 million for Q1 2025, reflecting a decrease of $4.1 million or 27.7% from Q1 2024, attributed to pricing strategy impacts and changes in distributor and ASC buying patterns[6] - Total revenue for Q1 2025 was $10.698 million, a decrease of 27.1% compared to $14.774 million in Q1 2024[30] - Product revenue, net for Q1 2025 was $10.634 million, down from $14.715 million in Q1 2024, reflecting a decline of 27.8%[30] - The net loss for Q1 2025 was $(64.1) million, or $(0.38) per share, compared to a net loss of $(64.8) million, or $(0.49) per share, in Q1 2024[12] - The net loss for Q1 2025 was $64.053 million, slightly improved from a net loss of $64.848 million in Q1 2024[30] - The company reported a basic net loss per share of $0.38 for Q1 2025, compared to $0.49 for Q1 2024[30] Expenses - Research and development expenses increased to $42.9 million in Q1 2025 from $20.7 million in Q1 2024, driven by clinical trial costs for SOL-1 and SOL-R[9] - Selling and marketing expenses rose to $14.1 million in Q1 2025, compared to $10.2 million in Q1 2024, mainly due to increased personnel-related costs[10] - General and administrative expenses were $16.3 million in Q1 2025, up from $14.1 million in Q1 2024, primarily due to higher personnel-related costs[11] Cash and Assets - Cash balance as of March 31, 2025, was $349.7 million, expected to support planned expenses and capital requirements into 2028[4] - Cash and cash equivalents decreased to $349.681 million as of March 31, 2025, down from $392.102 million as of December 31, 2024[28] - Total current assets decreased to $387.694 million as of March 31, 2025, from $440.987 million as of December 31, 2024, a decline of 12.0%[28] - Total liabilities as of March 31, 2025, were $139.990 million, a slight decrease from $142.591 million as of December 31, 2024[28] - The company’s accumulated deficit increased to $955.137 million as of March 31, 2025, compared to $891.084 million as of December 31, 2024[28] Clinical Trials and Development - SOL-1 trial is on track for topline data readout in Q1 2026, with exceptional retention rates and FDA-approved re-dosing amendments[3] - Enrollment for SOL-R trial remains strong, with target randomization reduced to approximately 555 subjects, expected to accelerate trial readout[8] - Positive FDA feedback received for AXPAXLI registrational trial design in NPDR, with plans for next steps in development for NPDR and DME[8] - The company anticipates advancing the development of AXPAXLI for additional indications such as NPDR and DME[25]

Core Insights - Ocular Therapeutix is advancing its AXPAXLI registrational program for wet AMD with a focus on redefining the retina experience and improving long-term outcomes [2][3] - The company received positive FDA feedback for a potential registrational trial design for AXPAXLI in non-proliferative diabetic retinopathy (NPDR) [2][3] - The company reported a cash balance of $349.7 million as of March 31, 2025, which is expected to support operations through 2028 [4] Clinical Trials and Developments - SOL-1 trial for wet AMD is on track for topline data readout in 1Q 2026, with exceptional retention rates and a recent FDA amendment allowing re-dosing at Weeks 52 and 76 [3][14] - SOL-R trial enrollment remains strong, with a reduced target of approximately 555 subjects, and is expected to accelerate trial readout [3][17] - The primary endpoint for SOL-1 is maintaining visual acuity at Week 36, while SOL-R aims to demonstrate non-inferiority in mean BCVA change at Week 56 [16][19] Financial Performance - Total net revenue for Q1 2025 was $10.7 million, a 27.6% decrease from $14.8 million in Q1 2024, primarily due to lower DEXTENZA sales [5][6] - Net product revenue was $10.6 million for Q1 2025, reflecting a 27.7% decrease compared to the same quarter in 2024 [6] - Research and development expenses increased to $42.9 million in Q1 2025, up from $20.7 million in Q1 2024, due to costs associated with clinical trials [8] Market Context - Wet AMD affects approximately 14.5 million individuals globally, with significant challenges in current treatment regimens leading to undertreatment and lack of long-term vision improvement [20][21] - The company aims to address these challenges with AXPAXLI, which is designed to provide a more sustainable therapy with a potential dosing regimen of every 6 to 12 months [2][3]