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]

Financial Data and Key Metrics Changes - The company aims to improve patient sustainability and reduce dropout rates, with a target to increase treatment adherence by even 10%, potentially preventing a quarter million people from going blind in the U.S. alone [16][5][6] Business Line Data and Key Metrics Changes - The company is focused on developing a retina-targeted drug, ex Paxley, with two main goals: enhancing sustainability of treatment and improving long-term outcomes for patients [4][7] Market Data and Key Metrics Changes - The dropout rate for anti-VEGF treatments in the U.S. is reported at 40%, which is significantly higher than in other markets, indicating a substantial opportunity for the company's product [15][16] Company Strategy and Development Direction - The company has redefined its identity to focus on retina treatments, emphasizing the need for sustainable therapies that address the long-term outcomes of patients suffering from retinal diseases [3][4][9] - The strategic approach includes a two-phase clinical trial design (SOUL one and SOLAR) that complements each other, aiming for regulatory approval and commercial advantage [34][40][42] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the regulatory pathway for their product, highlighting that they are following FDA guidelines closely, which positions them favorably compared to competitors [18][20] - The company is optimistic about the upcoming results from the SOLAR trial and its potential impact on the market, particularly in the diabetic retinopathy and diabetic macular edema segments [61][62] Other Important Information - The company has amended its trial design to enhance patient retention and meet FDA safety requirements, reducing the number of patients needed for the SOLAR study, which is expected to expedite the process [59][58] Q&A Session Summary Question: What is the company's strategy in the current competitive landscape? - The company aims to address the high dropout rates associated with existing treatments and believes that improving sustainability can significantly impact patient outcomes [16][5] Question: How does the company ensure the robustness of its clinical trials? - The company emphasizes careful patient selection and trial design to mitigate risks and enhance the likelihood of success, ensuring that the studies are conducted according to FDA guidelines [29][34] Question: What are the expectations for the upcoming SOLAR trial? - Management is confident that the trial will yield positive results, with a focus on patient retention and adherence to treatment protocols, which are critical for the trial's success [50][52]

Group 1 - Ocular Therapeutix reported a quarterly loss of $0.37 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.29, and compared to a loss of $0.24 per share a year ago, indicating an earnings surprise of -27.59% [1] - The company posted revenues of $10.7 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 37.36%, and down from $14.77 million in the same quarter last year [2] - Ocular Therapeutix shares have increased about 3% since the beginning of the year, contrasting with the S&P 500's decline of -3.3% [3] Group 2 - The earnings outlook for Ocular Therapeutix is currently unfavorable, leading to a Zacks Rank 4 (Sell) for the stock, indicating expected underperformance in the near future [6] - The current consensus EPS estimate for the upcoming quarter is -$0.29 on revenues of $17.84 million, and for the current fiscal year, it is -$1.19 on revenues of $71.74 million [7] - The Medical - Drugs industry, to which Ocular Therapeutix belongs, is currently in the top 25% of Zacks industries, suggesting a favorable industry outlook [8]

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 Viewpoint - Ocular Therapeutix, Inc. is actively participating in several investor and scientific conferences in May 2025 to showcase its advancements in retinal therapies and engage with the investment community [1][2][3]. Upcoming Investor Conferences - Ocular Therapeutix will present at the Citizens JMP Life Sciences Conference on May 7, 2025, at 9:00 AM ET in New York, NY, with CEO Pravin U. Dugel as the presenter [2]. - The company will also participate in the Bank of America 2025 Global Healthcare Conference on May 13, 2025, at 9:20 AM PT in Las Vegas, NV, again featuring CEO Pravin U. Dugel [2]. Upcoming Scientific Conferences - At the Eyecelerator @ Park City 2025, Ocular will have a panel titled "Retina in Office" on May 2, 2025, focusing on novel drug delivery approaches for glaucoma and retina, with Chief Medical Officer Nadia K. Waheed as a panelist [3]. - Ocular will present at the Association for Research in Vision and Ophthalmology (ARVO) 2025 on May 6, 2025, discussing the HELIOS trial for diabetic retinopathy, with Neal Shah, MD, as the presenter [4]. - The company will also showcase various posters at ARVO 2025, including studies on axitinib hydrogel injections and their effects on diabetic retinopathy [5][6]. Company Presentation Highlights - Ocular Therapeutix will present on "Retina - TKI and Drug Delivery Showcase" on May 2, 2025, with Chief Strategy Officer Sanjay Nayak as the presenter [4]. - The company will also participate in the Retina World Congress (RWC) 2025, presenting updates on clinical trials related to axitinib intravitreal hydrogel and diabetic retinopathy on May 9 and 10, 2025 [7][8]. Company Overview - Ocular Therapeutix is a biopharmaceutical company focused on retinal disease therapies, with its investigational product AXPAXLI (axitinib intravitreal hydrogel) currently in Phase 3 clinical trials for wet age-related macular degeneration [9]. - The company also leverages its proprietary ELUTYX technology in its commercial product DEXTENZA, an FDA-approved treatment for ocular inflammation and pain [10].

Core Viewpoint - Ocular Therapeutix, Inc. plans to release its first quarter 2025 financial results on May 5, 2025, at 7:00 AM Eastern Time, and will not hold a conference call for this quarter, resuming calls for the second quarter 2025 [1]. Company Overview - Ocular Therapeutix, Inc. is a biopharmaceutical company focused on redefining the retina experience [3]. - The company’s investigational product AXPAXLI™ (axitinib intravitreal hydrogel, also known as OTX-TKI) is in Phase 3 clinical trials for wet age-related macular degeneration (wet AMD) [3]. - Ocular's pipeline includes DEXTENZA, an FDA-approved corticosteroid for treating ocular inflammation and pain post-surgery, and PAXTRAVA™ (travoprost intracameral injection or OTX-TIC), which is in Phase 2 clinical trials for open-angle glaucoma or ocular hypertension [4].

Core Viewpoint - Ocular Therapeutix is experiencing positive market sentiment, leading to a nearly 5% increase in stock price week to date, driven by a bullish analyst coverage initiation [1] Group 1: Analyst Coverage - Needham's analyst Serge Belanger initiated coverage on Ocular Therapeutix, rating the stock as a buy with a price target of $15 per share, nearly double its current level [2] - Belanger believes in Ocular's potential primarily due to its investigational drug Axpaxli, which targets wet age-related macular degeneration (AMD) [3] Group 2: Drug Potential - Axpaxli is noted for its longer duration compared to comparable medications, positioning it as a standout treatment option [4] - The drug has the potential to become a blockbuster, especially for patients requiring a maintenance regime [4] Group 3: Market Opportunity - There is a significant patient base for wet AMD in the U.S., with approximately 200,000 new cases diagnosed annually, indicating a strong market opportunity for Axpaxli [5]

Group 1 - Ocular Therapeutix reported a quarterly loss of $0.29 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.24, representing an earnings surprise of -20.83% [1] - The company posted revenues of $17.08 million for the quarter ended December 2024, exceeding the Zacks Consensus Estimate by 2.40%, and showing an increase from $14.8 million in the same quarter last year [2] - Ocular Therapeutix shares have declined approximately 16.4% since the beginning of the year, contrasting with the S&P 500's gain of 1.2% [3] Group 2 - The earnings outlook for Ocular Therapeutix is mixed, with the current consensus EPS estimate for the upcoming quarter at -$0.27 on revenues of $16.79 million, and -$1.05 on revenues of $70.1 million for the current fiscal year [7] - The Zacks Industry Rank indicates that the Medical - Drugs sector is currently in the bottom 48% of over 250 Zacks industries, suggesting potential underperformance compared to the top 50% of ranked industries [8]

BEDFORD, Mass., Oct. 09, 2024 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, "Ocular"), a biopharmaceutical company committed to improving vision in the real world through the development and commercialization of innovative therapies for retinal diseases and other eye conditions, today announced participation in multiple panels and presentations across three ophthalmology meetings in Chicago, Illinois during October 2024. Presentation & Panel Details (all times CT): Eyecelerator® @ AAO 2024: Oc ...