CorMedix Analyst Day Summary Company Overview - **Company**: CorMedix - **Event**: 2026 Analyst and Investor Day - **Key Leadership**: Joe Todisco (Chairman and CEO), Liz Hurlburt (COO), Susan Blum (CFO), Mike Seckler (CCO), Matt David (Chief Business Officer), Beth Levine (Chief Legal and Compliance Officer) [3][5][6] Financial Performance - **2025 Performance**: Achieved nearly $260 million in net sales, strong cash flow, and completed the acquisition of Melinta Therapeutics, adding approximately $140 million in pro forma revenue [6][9] - **2026 Guidance**: Projected EBITDA in the range of $100-$125 million, with a market cap approximately five times that guidance [9] Product Portfolio and Strategy - **Focus**: Transition year for promoting existing commercial assets while preparing for future pipeline launches [6] - **Acquisition Impact**: Transformation into a diversified specialty pharmaceutical company with a focus on injectable drugs in institutional settings [7] - **Key Products**: - **Rezzayo (Rezafungin)**: Next-generation echinocandin antifungal approved for candidemia and invasive candidiasis, with ongoing studies for prophylaxis in immunocompromised patients [12][13] - **DefenCath**: Focus on preventing CLABSI in patients undergoing total parenteral nutrition, with expectations for a rebound in 2027 [9][10] Market Opportunities - **Rezzayo**: - Total addressable market estimated at $250 million-$350 million for current indications, with significant growth potential in outpatient infusion centers [13][14] - Ongoing phase III study for prophylaxis in immunocompromised patients, with results expected in Q2 2026 [65] - Expansion potential into a broader patient population at risk for invasive opportunistic infections, with a total addressable market exceeding $2 billion [64] Clinical Insights and Challenges - **Clinical Advantages of Rezzayo**: - Once-weekly dosing, favorable pharmacokinetics, and reduced drug-drug interactions compared to azoles [12][62] - Addresses challenges of azole resistance, particularly with Candida auris and other resistant species [59][62] - **Prophylaxis Needs**: High-risk populations, including those undergoing stem cell transplants and treatments for hematologic malignancies, require effective antifungal prophylaxis [62][63] - **Current Limitations**: Existing antifungal options face challenges with hepatotoxicity and drug interactions, complicating treatment regimens for immunocompromised patients [71][72] Key Takeaways from Expert Panels - **Panel Insights**: Experts emphasized the importance of understanding local epidemiology and the need for timely diagnostics and treatment strategies for candidiasis [18][22] - **Social Determinants**: Accessibility to care and support structures for patients are critical factors influencing treatment adherence and outcomes [54][56] - **Emerging Resistance**: The increasing prevalence of drug-resistant Candida species highlights the urgent need for effective treatment options like Rezafungin [59][62] Conclusion CorMedix is positioned for sustainable growth through its diversified portfolio and strategic focus on addressing unmet clinical needs in antifungal therapies. The company aims to leverage its innovative products to capture significant market opportunities while navigating the complexities of the healthcare landscape.

Core Insights - CorMedix (CRMD) acquired Melinta Therapeutics for $300 million in August 2025, diversifying its revenue base and reducing reliance on its primary product, DefenCath [1][12] - The acquisition added seven approved products to CRMD's portfolio, contributing $12.8 million to its revenue in Q3 2025 [2][12] - DefenCath, approved by the FDA in late 2023, generated $167.6 million in net sales during the first nine months of 2025 [3] Revenue and Growth Opportunities - The Melinta acquisition is expected to create near-term growth opportunities, particularly through Rezzayo, which targets a market exceeding $2 billion for antifungal prophylaxis [4] - CRMD raised its full-year 2025 pro forma net revenue guidance to $390-$410 million, up from a previous estimate of at least $375 million, reflecting strong momentum from DefenCath and early contributions from Melinta [5] Competitive Landscape - Despite strong adoption of DefenCath, competition from major players like Pfizer, Amphastar Pharmaceuticals, and others poses a risk to CRMD's market position [6][7] - These competitors have stronger pipelines and greater resources, which could challenge CorMedix's growth outlook [8] - If Pfizer or Amphastar expands into catheter-related infection prevention, CRMD may face significant competitive pressure [10] Stock Performance and Valuation - CRMD shares have decreased by 2.5% over the past six months, underperforming the industry, which has rallied by 26.8% [13] - The stock is trading at a discount to the industry, with a price/book ratio of 2.55 compared to the industry average of 3.68 [14] - Earnings estimates for 2025 have improved from $1.85 to $2.87 per share, and for 2026 from $2.49 to $2.88 [15]

Core Insights - CorMedix Inc. has completed enrollment for the Phase III ReSPECT trial, which evaluates the efficacy of REZZAYO® (rezafungin) in preventing fungal infections in adult patients undergoing allogeneic blood and marrow transplantation (BMT) [1][2] - Topline results from the ReSPECT study are expected in the second quarter of 2026, which is a significant milestone towards seeking FDA approval for REZZAYO in this indication [2][5] - The ReSPECT trial is a multicenter, randomized, double-blind study comparing once-weekly rezafungin to a standard antimicrobial regimen, with the primary endpoint being fungal-free survival at day 90 [2][3] Company Overview - CorMedix is a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases, including antifungal treatments [4] - Following the acquisition of Melinta Therapeutics in August 2025, CorMedix is expanding its portfolio to include various anti-infective products alongside REZZAYO [4][5] - REZZAYO is already approved in the U.S. for treating candidemia and invasive candidiasis, with an estimated addressable market of approximately 130,000 patients for antifungal prophylaxis, translating to a total addressable market of over $2 billion [3][4] Product Details - REZZAYO (rezafungin) is a next-generation echinocandin indicated for patients with limited treatment options for candidemia and invasive candidiasis [3][7] - The drug has orphan drug exclusivity until 2035 and patent coverage until 2038 in the U.S., enhancing its market potential [3]