CRMD — CorMedix Inc.

Summary of CorMedix Q1 2026 Earnings Call

1. Key Financial Results and Metrics

• Net Revenue: $127.4 million for Q1 2026, significantly up from $39.1 million in Q1 2025.
• DefenCath Sales: Contributed $97.5 million, with an additional $29.9 million from the Melinta portfolio.
• Adjusted EBITDA: $70 million, compared to $23.6 million in Q1 2025.
• Net Income: $38.6 million, or $0.48 per basic share, up from $20.6 million, or $0.32 per basic share in the prior year.
• Cash Position: $178.1 million in cash and cash equivalents at quarter-end, with cash generated from operating activities of $42.4 million.

2. Strategic Updates and Business Highlights

• CorMedix is focused on increasing DefenCath utilization and expanding its pipeline, including REZZAYO for prophylaxis of invasive fungal disease.
• The company announced positive preliminary results from the ReSPECT study for REZZAYO, positioning it as a potential option for clinicians.
• Plans to enhance commercial readiness for REZZAYO include hiring 15-20 additional staff and increasing operating expenses to support growth initiatives.
• The company is actively pursuing new customer contracts and expanding its market presence, particularly in Medicare Advantage.

3. Forward Guidance and Outlook

• Revised Revenue Guidance: Increased for 2026 from $300-$320 million to $325-$345 million, reflecting strong Q1 performance and demand trends.
• Adjusted EBITDA Guidance: Raised from $100-$125 million to $115-$135 million for the year.
• DefenCath Sales Guidance: Increased from $150-$170 million to $175-$195 million for 2026, factoring in existing customer run rates.
• Anticipates variability in DefenCath sales in the second half of 2026 due to the expiration of TDAPA reimbursement.

4. Bad News, Challenges, or Points of Concern

• The expiration of TDAPA reimbursement is expected to lead to price erosion and variability in DefenCath sales in the latter half of 2026.
• Enrollment in the TPN study is lagging, with completion now trending towards 2028 due to lower-than-expected infection rates and challenges in patient recruitment.
• The company faces potential risks associated with the transition to a bundled payment system and the impact on pricing and utilization.

5. Notable Q&A Insights

• Management confirmed that the second quarter would likely see a revenue range of approximately $60 million for DefenCath, adjusting for a one-time $9 million benefit in Q1.
• Discussions about the TPN trial indicated that changes to the inclusion criteria could help accelerate enrollment, but the patient profile is expected to remain complex.
• The company is optimistic about REZZAYO's market potential but acknowledged that full data publication is necessary before engaging in detailed payer negotiations and pricing strategies.
• Management emphasized the importance of maintaining strong relationships with existing customers and leveraging positive clinical outcomes to drive future sales.

Overall, CorMedix demonstrated strong financial performance in Q1 2026, with positive momentum in DefenCath sales and promising developments in its clinical pipeline, while also navigating challenges related to reimbursement changes and clinical trial enrollment.