Financial Data and Key Metrics Changes - The company anticipates a greater than $5 billion commercial opportunity starting at the end of the decade, escalating into the early 2030s [10] - The influenza season last year saw 1.6 million hospitalizations, indicating a significant unmet medical need [9] Business Line Data and Key Metrics Changes - The CD388 drug shows 76% efficacy in the chosen dose for phase three, outperforming traditional flu vaccines [5][6] - Ohtuvayre, acquired from Verona, is expected to significantly scale up the company's commercial efforts in treating COPD, with excellent feedback from the market [17][18] Market Data and Key Metrics Changes - Approximately 110 million people in the U.S. are expected to be candidates for CD388 treatment, with 85 million being high-risk or immunocompromised individuals [7][9] - The company is seeing positive uptake in the pulmonary arterial hypertension (PAH) market, with WINREVAIR meeting high expectations [28][29] Company Strategy and Development Direction - The company is focusing on expanding its respiratory portfolio and leveraging its commercial engine to maximize the potential of newly acquired products [17][20] - There is a strong emphasis on addressing unmet needs in various therapeutic areas, including COPD and pulmonary hypertension, with plans for phase three trials in the near future [21][22] Management's Comments on Operating Environment and Future Outlook - Management acknowledges the significant unmet need in the influenza treatment space and believes CD388 will provide a compelling value proposition [10] - The company is optimistic about the future of its immunology pipeline, with multiple indications expected to show promising results in the coming years [66][67] Other Important Information - The company is preparing for the launch of an oral PCSK9 inhibitor, which is expected to improve access and adherence to cholesterol-lowering therapies [46][47] - The vaccine portfolio, including Gardasil, is expected to see modest growth despite challenges in certain markets [54][55] Q&A Session Summary Question: Insights on the Cidara deal and its growth opportunity - Management highlighted the high unmet medical need for influenza treatment and the strain-agnostic efficacy of CD388, which is expected to protect high-risk populations [5][6][10] Question: Commercial approach for CD388 and payer context - The company plans to include both vaccinated and unvaccinated high-risk individuals in the phase three program, with research indicating a price point of $500 to $600 per dose would be acceptable to payers [12][13] Question: Updates on Ohtuvayre and its market potential - Management expressed confidence in Ohtuvayre's potential, citing excellent feedback from customers and a significant opportunity to scale its commercial efforts [17][18] Question: Future steps for WINREVAIR and phase three trials - The company plans to start phase three trials next year, focusing on the design to meet regulatory expectations and payer requirements [24][25] Question: Expectations for the oral PCSK9 program - Management believes the oral PCSK9 will provide robust LDL lowering and improve access for patients, potentially changing treatment guidelines [46][47] Question: Updates on the vaccine portfolio and Gardasil - The company anticipates modest growth for Gardasil and is optimistic about the launches of new vaccines like CAPVAXIVE [54][58]

Financial Data and Key Metrics Changes - The company anticipates a greater than $5 billion commercial opportunity starting at the end of the decade and escalating into the early 2030s, particularly with the CD388 antiviral treatment for influenza [9] - The company expects modest single-digit growth for Gardasil going forward, despite challenges in the China market, which represents less than 1% of revenue [54] Business Line Data and Key Metrics Changes - CD388 shows 76% efficacy in the chosen dose for phase 3 trials, which is better than existing flu vaccines [6] - Ohtuvayre, acquired from Verona, is expected to significantly scale up the company's respiratory portfolio, with excellent feedback from customers [17][18] - Winrevair in pulmonary arterial hypertension (PAH) is meeting high expectations, with continuous positive feedback from the medical community [28][30] Market Data and Key Metrics Changes - In the U.S., approximately 110 million people are expected to be candidates for CD388 treatment, with about 85 million being high-risk or immunocompromised individuals [7][8] - The company is seeing encouraging uptake in the U.S. for Winrevair, particularly among patients on triple therapy for PAH [31] Company Strategy and Development Direction - The company is focusing on expanding its respiratory portfolio and leveraging its commercial engine to maximize the potential of newly acquired products like Ohtuvayre [17][20] - The strategy includes a strong emphasis on addressing unmet medical needs, particularly in underserved populations such as those with heart failure and pulmonary hypertension [22][24] - The company is also exploring combination therapies in immunology, aiming to broaden the application of its TL1A drug across multiple indications [67][69] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the commercial potential of CD388, highlighting its unique position as an antiviral that provides protection regardless of influenza strain [7][9] - The company is preparing for a challenging influenza season and aims to provide effective protection for high-risk individuals [9] - Management acknowledged the need for ongoing discussions with the FDA regarding the design of phase 3 trials for various products, emphasizing the importance of regulatory guidance [24][26] Other Important Information - The company is committed to driving growth in its vaccine portfolio, with Capvaxive and influenza vaccines expected to perform well in the market [58] - The acquisition of Prometheus is seen as a strategic move to enhance the company's capabilities in treating inflammatory diseases [67] Q&A Session Summary Question: What is the expected market opportunity for CD388? - The company anticipates a greater than $5 billion commercial opportunity starting at the end of the decade, particularly for high-risk populations [9] Question: How is the feedback for Ohtuvayre? - Feedback has been excellent, and the company believes there is a huge opportunity to scale the product [17][18] Question: What are the expectations for Winrevair in PAH? - Winrevair is meeting high expectations, with positive feedback from the medical community and increasing uptake among patients [28][30] Question: How does the company plan to approach the FDA for phase 3 trials? - The company plans to consult with the FDA regarding trial design and aims to ensure that the studies are appropriately sized for critical endpoints [24][26] Question: What is the outlook for Gardasil? - The company expects modest single-digit growth for Gardasil, despite challenges in the China market [54]

Summary of CorMedix Conference Call Company Overview - **Company**: CorMedix - **Recent Development**: CorMedix has undergone a transformational acquisition of Millenta, shifting from a single product company focused on DefenCath to a multi-product company with a broader portfolio of approved anti-infective drugs [3][22] Core Product: DefenCath - **Product Description**: DefenCath is an antimicrobial catheter lock solution aimed at reducing bloodstream infections, particularly in hemodialysis patients [3][4] - **Market Launch**: Launched in July 2024, with approximately 90% of hemodialysis sessions occurring in outpatient settings [5][6] - **Market Dynamics**: The hemodialysis market is highly concentrated, with five providers controlling over 90% of the market [5] - **Adoption Rate**: Initial adoption has been positive, with US Renal Care being the first to implement DefenCath, followed by other mid-sized players [6][7] - **Guidance Update**: DefenCath revenue guidance for 2025 has been raised to between $200 million and $250 million, driven by strong performance in non-LDO customers [21][22] Competitive Advantage - **Unique Selling Proposition**: DefenCath combines heparin and taurolidine, offering antimicrobial properties not found in standard locking solutions like heparin or saline [9][10] - **Market Position**: As the first and only FDA-approved antimicrobial catheter lock solution, DefenCath is positioned to become the new standard of care [9][10] Acquisition of Millenta - **Strategic Rationale**: The acquisition provides a stable base business and growth opportunities, particularly in the hospital and outpatient infusion settings [22][23] - **Synergies**: Expected annual synergies from the acquisition are projected to be between $35 million and $45 million, with a timeline for capture within 12 months [27][28] Future Growth Opportunities - **Roseo**: A key product from Millenta, currently in phase 3 studies for treating invasive fungal infections, with a potential market size of $250 million [24][25] - **TPN Indication**: DefenCath is also being studied for use in total parenteral nutrition (TPN), with a total addressable market estimated between $500 million and $750 million [31][32] - **Oncology Setting**: Future development plans for DefenCath in oncology are being explored, with a focus on designing clinical trials that can capture a broad patient population [35][36] Reimbursement Environment - **Current Structure**: The TDAPA (Transitional Drug Add-on Payment Adjustment) is in its second year, impacting reimbursement for outpatient hemodialysis [17][18] - **Legislative Outlook**: Anticipation of potential legislation to codify TDAPA and improve reimbursement conditions [18][19] Key Milestones - **Upcoming Events**: The most significant near-term milestone is the readout of Roseo clinical data expected early to mid-next year, along with progress in commercializing DefenCath [46][47] Conclusion - **Outlook**: CorMedix is optimistic about its future direction post-Millenta acquisition, focusing on integration and synergy capture while driving growth through its product pipeline [47][48]