CorMedix (CRMD) investor relations material

Business transformation and portfolio expansion

• Transitioned from a pre-commercial, single-product company to a diversified specialty pharmaceutical firm with eight marketed products across 500+ hospitals and clinics in the past two years.

• Acquisition of Melinta provided a stable base of anti-infective drugs and a future growth asset in REZZAYO, transforming the business and strengthening its institutional presence.

• Commercial platform is scalable, focused on institutional settings, and positioned for further synergistic asset additions.

• Strategic investment in Talphera and readiness to add more products without significant expansion of field teams.

• Portfolio durability supported by long-term IP and technological barriers, with most products protected into the 2030s and 2040s.

DefenCath commercialization and reimbursement dynamics

• Successfully navigated TDAPA reimbursement, transitioning to bundled add-on payments in July 2024, with price discounts to maintain patient volumes.

• Working to secure separate reimbursement for Medicare Advantage patients, representing 60-65% of the market, to enhance long-term value.

• Engaged with CMS to advocate for a new functional category for infection prevention, aiming for sustainable reimbursement.

• Pilot agreement with the largest dialysis operator, now covering all top five providers, validates clinical value and expands reach.

• Real-world evidence, including a 72% reduction in bloodstream infections, supports payer negotiations and further adoption.

REZZAYO growth prospects and launch preparation

• Phase III data for prophylaxis met primary endpoint for non-inferiority and showed improved safety versus standard azole antifungals.

• Prophylaxis indication could expand REZZAYO's addressable market eightfold, with a $500 million TAM in bone marrow transplant patients alone.

• Market opportunity extends to patients contraindicated for azoles, with 15-20% discontinuation rates due to toxicity or interactions.

• Launch preparations include targeted hiring and leveraging existing commercial infrastructure, with full data set and sNDA acceptance expected in the coming quarters.

• U.S. NDA ownership will transfer upon approval, enabling direct control over commercialization and regulatory strategy.