Summary of Outlook Therapeutics Conference Call Company Overview - **Company**: Outlook Therapeutics - **Ticker**: OTLK (trades on Nasdaq) [4] Recent Achievements - **Product**: Lightnova - **Regulatory Approvals**: Lightnova approved in the EU and UK; received positive recommendation from NICE for use in the UK [5][6] - **Launch**: Launched simultaneously in Germany and the UK in May 2025; first patients dosed in both countries [6] Market Landscape - **Industry**: Treatment of wet Age-related Macular Degeneration (AMD) - **Market Size**: The European market for wet AMD treatments is valued at approximately $3.6 billion annually, with 8 million anti-VEGF injections per year [9] - **Injection Distribution**: Germany accounts for 1.7 million injections, while the UK accounts for 1.3 million [10] Competitive Positioning - **Market Share**: Off-label bevacizumab holds a 33% market share in Europe, with Germany at 50% and the UK at 5% [11][12] - **Cost-Effectiveness**: Lightnova positioned as a cost-effective first-line treatment option for wet AMD [9][12] Pricing Strategy - **UK Pricing**: List price set at £470, the lowest among approved products; patient access scheme in place for competitive net pricing [16][18] - **Germany Pricing**: List price set at €751.61; negotiations for a post-launch price expected in early 2026 [20][19] Commercial Launch Strategy - **Market Access**: Focus on subnational access critical for success; rebate agreements in place covering 50% of the population in Germany, expected to increase to 90% by year-end [26] - **Team Experience**: Strong teams with extensive ophthalmology experience in both Germany and the UK [24] Physician Engagement - **Receptiveness**: Positive feedback from ophthalmologists regarding Lightnova; significant interest in an ophthalmic standard formulation of bevacizumab [13][14] - **Educational Efforts**: Focus on educating physicians about the ophthalmic formulation and clinical data supporting Lightnova [35][36] Future Expansion Plans - **Market Expansion**: Approved in 31 countries; focus on launching in Italy, Spain, France, Ireland, and the Nordics [44][47] - **Potential Partnerships**: Currently focused on maximizing Lightnova's potential independently, but open to partnerships if beneficial [48] FDA Approval Update - **BLA Submission**: BLA submitted to the FDA in February 2025; PDUFA goal date set for August 27, 2025 [50][51] - **Expectations**: Confident in the data provided to the FDA supporting approval for wet AMD treatment [75][76] Financial Outlook - **Liquidity**: Recent capital raised through a CMPO; sufficient funds to support operations through the PDUFA decision [58] - **Profit Margins**: Anticipated healthy profit margins, with a focus on minimizing dilution during financing [63] Conclusion - **Key Milestones**: Upcoming quarterly results expected in August, along with the FDA decision; preparations for further European launches ongoing [84][85]

Financial Data and Key Metrics Changes - As of December 31, 2024, the company's cash and cash equivalents totaled approximately $20 million, which is expected to fund operations into the fourth quarter of 2025 [27] - The company is actively pursuing options to fund the CLSAX Phase III program, including potential partnerships with third parties [27] Business Line Data and Key Metrics Changes - The SES microinjector has been used for over 15,000 suprachoroidal injections, indicating strong interest from retinal specialists and pharmaceutical companies [6] - Positive results from the Odysee Phase 2b clinical trial have led to a successful end of Phase II meeting with the FDA regarding CLSAX [6][7] Market Data and Key Metrics Changes - The wet AMD market represents over $12 billion in annual sales, highlighting the commercial potential for CLSAX [22] - The company’s partner Arctic Vision has achieved several regulatory milestones in the Asia Pacific region, with products approved in Australia and Singapore [9] Company Strategy and Development Direction - The company aims to position CLSAX as a leading maintenance treatment for wet AMD, focusing on reducing variability in clinical trial outcomes [11][21] - The Phase III trial design includes two pivotal non-inferiority trials, which are expected to maximize commercial opportunities and reduce regulatory risks [14][22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the Phase III program's design and its potential to demonstrate the drug's efficacy and safety [39][40] - The company is optimistic about the broad applicability of suprachoroidal delivery in treating serious retinal diseases, with ongoing evaluations for additional small molecule treatments [23][25] Other Important Information - The company is preparing for participation in upcoming healthcare conferences to further engage with stakeholders [27] - The management team emphasized the importance of flexible dosing regimens in the competitive landscape of wet AMD treatments [22] Q&A Session Summary Question: How might the amendments to the planned Phase III improve results from Phase II? - Management believes that moving to a more general patient population will yield better results, as the previous Phase II focused on difficult-to-treat patients [35] Question: How long is expected to enroll the treatment-naive population? - Enrollment is expected to take around twelve months, based on recent trials [38] Question: What is the estimated overall cost of the Phase III program? - While specific costs were not disclosed, similar Phase III trials have been estimated around $55 million to $60 million [46] Question: What is the financing strategy for the Phase III study? - The company is pursuing options to fund the clinical part of the study, including potential partnerships [52] Question: Can you elaborate on the redosing criteria? - Redosing will rely on OCT biomarkers, with a focus on intra-retinal fluid, and will be scientifically justified to reduce variability [75][76]