CorMedix Inc. Q1 FY2026 earnings call

Core Business Performance and Growth Strategy

• CoreMedix entered 2026 with strong momentum across its three core strategic pillars: sustained cash-generating growth from DefendCast, advancement of high-value pipeline opportunities, and delivery of consistent profitability and cash flow to support reinvestment and shareholder returns.
• DefendCast is progressing toward becoming a standard of care in its target patient population, with positive real-world clinical data published or presented by the company's three largest customers demonstrating reduced infection and CRBSI-related hospitalization rates, supporting ongoing adoption despite upcoming reimbursement changes.
• The company continues to pursue new revenue upside via new customer onboarding and successful contracting for DefendCast with Medicare Advantage plans, where currently less than 10% of the company's patients are covered.

Pipeline and Clinical Updates

• The company announced positive preliminary top-line results from the Phase III RESPECT study for Roseo (prophylaxis for invasive fungal disease in allogeneic bone marrow transplant patients). The study met its primary endpoint of 90-day fungal-free survival, demonstrating non-inferiority to the standard of care regimen (60.7% vs 59% fungal-free survival) with a favorable safety profile, including fewer treatment-emergent adverse events leading to dose modification or study discontinuation.
• A pre-NDA meeting with the FDA is scheduled in the coming weeks, with the SNDA submission planned for H2 2026, targeting a potential 2027 U.S. commercial launch. The company will add 15-20 new incremental headcount for commercial and medical operations in H2 2026 to prepare for launch.
• The Phase III NutriGuard study of DefendCast for TPN indications has slower-than-expected enrollment: current enrollment is only one-third of the 90 patients needed for interim analysis, and lower-than-projected CLABSI infection rates have pushed expected study completion to 2028. The company plans to open additional clinical sites and submit a protocol amendment to the FDA to expand inclusion criteria to accelerate enrollment.

CoreMedix reported total first quarter 2026 net revenue of $127.4 million, a large increase from $39.1 million in the prior year period. The DefendCast segment contributed $97.5 million in revenue, accounting for 76.5% of total net revenue for the quarter. This includes a one-time non-recurring $9 million favorable adjustment related to sales allowances (Medicaid rebates and product returns); even excluding this adjustment, DefendCast net revenue outperformed consensus expectations. The Malinta acquired product portfolio contributed $29.9 million in revenue, representing 23.5% of total net revenue. Total first quarter operating expenses were $41.5 million, consisting of $7.2 million in R&D, $12.5 million in selling and marketing, and $21.7 million in G&A. GAAP net income was $38.6 million ($0.48 per basic share, $0.43 per diluted share), compared to $20.6 million ($0.32 per basic share, $0.30 per diluted share) in Q1 2025. Non-GAAP adjusted EBITDA was $70 million, up from $23.6 million in the prior year period. The company ended the quarter with $178.1 million in unrestricted cash and cash equivalents, and generated $42.4 million in operating cash flow.

• Full year 2026 net revenue guidance was increased from the prior range of $300-$320 million to a new range of $325-$345 million, representing an upward revision driven by strong Q1 execution and underlying demand, while accounting for expected sales variability in H2 due to Tdapa reimbursement transition.
• Full year 2026 adjusted EBITDA guidance was raised from the prior range of $100-$125 million to a new range of $115-$135 million, an upward revision.
• Full year 2026 DefendCast revenue guidance was increased from the prior range of $150-$170 million to a new range of $175-$195 million. This guidance is based on existing customer run rates and excludes potential upside from new customers or Medicare Advantage contracting.
• Full year 2026 cash operating expenses (excluding non-cash charges like stock-based compensation) are guided to a range of $145-$160 million, which includes the incremental commercial preparation spend for the potential Roseo launch.
• Management expects a significant increase in post-Tdapa add-on reimbursement from CMS in 2027, leading to a higher net selling price per unit for DefendCast in 2027 compared to H2 2026, and affirmed prior 2027 DefendCast guidance, with potential for upward revision later this year or early 2027.

• The Tdapa initial reimbursement expiration at the end of June 2026 will lead to expected price erosion for DefendCast in H2 2026, and the transition to the new post-Tdapa reimbursement framework introduces variability to near-term sales results.
• The Phase III NutriGuard TPN study faces significant enrollment delays due to smaller-than-expected eligible patient pools and lower-than-projected infection rates, pushing study completion to 2028. Acceleration of enrollment is dependent on FDA approval of the proposed protocol amendment to expand inclusion criteria, which is not guaranteed.
• Future revenue upside from DefendCast is dependent on successful contracting with Medicare Advantage plans and onboarding of new customers, outcomes which are uncertain and not included in current guidance.
• Commercial launch outcomes and pricing for Roseo are still uncertain, as full clinical data has not yet been published and payer and KOL feedback is still pending.
• Forward-looking statements regarding future results, pipeline progress, and launch timelines are subject to material risks that could cause actual results to differ from projections, as detailed in the company's SEC filings.

Q: What should we expect for DefendCast revenue trend in Q2 2026 (adjusting for the $9M one-time benefit), and what is your updated outlook for DefendCast 2027? / A: The $9M benefit is one-time only. A shelf stock adjustment will occur in June 2026 ahead of the July 1 reimbursement change, so Q2 is expected to be a roughly two-month equivalent quarter with revenue around $60M +/- a couple million. For H2 2026, revenue can be derived from spreading the full-year guidance across Q3 and Q4. For 2027, the company affirms prior guidance, expects higher net selling prices than H2 2026, and may update guidance upward later this year or early 2027. Current guidance does not include upside from Medicare Advantage or new customers.

Q: How will the proposed NutriGuard TPN study protocol amendment impact the statistical plan, future labeling, and trial execution? / A: The company is adding 5 new sites in Turkey and additional U.S. sites to accelerate enrollment. If the amendment is approved, the statistical plan will be adjusted, but the primary target label indication (CLABSI risk reduction for adult TPN patients) will remain unchanged. Expansion of inclusion criteria could potentially expand the label if approved, but it will not change the core patient profile of the study, and specifics of the amendment will not be shared until FDA feedback is received.

Q: Given the positive Roseo RESPECT study results, has the priority for acquiring additional complementary assets changed over the next 12-18 months? / A: The priority for acquisitions has actually increased, not changed. The company is specifically focused on pursuing additional assets that are complementary to the planned Roseosales deployment in hematology/oncology clinics and bone marrow transplant centers, which remains a key strategic goal.

Q: Will the Roseo SNDA filing require additional data beyond the RESPECT study results, and when will label clarity be available? / A: The purpose of the upcoming pre-NDA meeting with the FDA is to confirm whether the existing RESPECT study and other supportive data is sufficient for the SNDA submission. Label details will not be confirmed until after FDA review and full data compilation, so it is premature to comment on the final label expansion at this stage. Partner Mundi Pharma leads regulatory activities in collaboration with CoreMedix.