CorMedix Therapeutics — Third Quarter 2026 Earnings Summary

Financial Performance:

• Consolidated revenue for Q3 2026 was $54.5 million, a decrease from $104.3 million in Q3 2025, driven by lower DefenCath pricing post-TDAPA transition on July 1, 2026, partially offset by a full quarter of Melinta portfolio sales compared to one month in 2025.
• DefenCath sales contributed $17.2 million in Q3 2026, down from prior year levels due to price impacts, though a $5.0 million favorable change in estimate for sales allowances supported revenue.
• The remainder of the portfolio generated $37.3 million in Q3 2026.
• Net loss for Q3 2026 was $14.7 million ($0.19 per share), compared to net income of $108.6 million ($1.42 basic, $1.26 diluted per share) in Q3 2025.
• Q3 2026 net loss included an $11.5 million non-cash expense for the remeasurement of contingent consideration related to the Melinta acquisition; Q3 2025 net income included a one-time tax benefit of $59.7 million.
• Adjusted EBITDA for Q3 2026 was $3.1 million, down from $71.9 million in Q3 2025.
• Total operating expenses were $36.6 million in Q3 2026, a 12% decrease from $41.7 million in Q3 2025, driven by lower merger-related and reorganization expenses.
• Cash and short-term investments (excluding restricted cash) totaled $355.2 million at September 30, 2026.
• Net cash provided by operating activities for the first nine months of 2026 was $218.3 million, compared to $80.6 million in the same period of 2025.

Guidance and Future Outlook:

• Maintains full-year 2026 consolidated revenue guidance of $325 million to $345 million.
• Narrows full-year 2026 adjusted EBITDA guidance to $130 million to $140 million (previously $125 million to $140 million).
• Reduces full-year 2026 cash-based operating expenses guidance to $140 million to $145 million (previously $145 million to $155 million).
• Suspends previously issued 2027 DefenCath revenue guidance due to changes in the CMS reimbursement framework, deferring future guidance until early 2027 to assess utilization, pricing, and Medicare Advantage contracting.
• Anticipates FDA action on the REZZAYO sNDA for expanded indication in Q1 2027.
• Expects the Heron asset acquisition to close in Q1 2027, subject to regulatory and stockholder approval, with anticipated revenue contribution of $125 million to $150 million for full-year 2027.

Business Segments and Product Lines:

• DefenCath (taurolidine and heparin) sales were driven by maintaining utilization among large outpatient dialysis customers despite post-TDAPA pricing pressures.
• The Melinta portfolio contributed to revenue growth in Q3 2026 due to a full quarter of sales compared to one month in Q3 2025.
• FDA accepted the sNDA for REZZAYO for the prophylaxis of invasive fungal disease in collaboration with Mundipharma; if approved, promotional efforts are planned for the second half of 2027.
• Pending acquisition of substantially all assets of Heron Therapeutics includes four commercial products used in institutional settings of care.

Market and Competitive Landscape:

• Revenue performance reflects execution in the post-TDAPA period for DefenCath, where price impacts have affected sales.
• Company dependence on a limited number of large dialysis organization customers remains a factor.
• Future visibility into 2027 pricing and utilization is expected to improve following CMS framework changes and potential Medicare Advantage contracting.

Risks and Challenges:

• Risks include the potential failure to complete the Heron acquisition, failure to realize anticipated revenue contributions or cost synergies, and integration risks.
• Clinical trial risks include potential changes in topline data, enrollment difficulties, and safety or efficacy concerns.
• Regulatory risks involve the timing and outcome of FDA review for REZZAYO and potential changes in reimbursement frameworks.
• Financial risks include reliance on a limited customer base and potential pricing pressures from governmental and private payers.

Management Commentary and Tone:

• Chairman & CEO Joseph Todisco stated the company is entering 2027 with two meaningful growth drivers: the Heron acquisition and the REZZAYO sNDA.
• Management expressed confidence in the Heron transaction being immediately accretive to earnings and free cash flow upon closing.
• The company highlighted a strong cash position and access to $150 million in non-dilutive capital via a term loan agreement with Pharmakon, expecting to utilize $75 million upon closing.
• Management emphasized a disciplined approach to capital deployment and strategy to generate value from DefenCath in the post-TDAPA era.

Other Key Points:

• CorMedix entered into a definitive asset purchase agreement to acquire substantially all assets of Heron Therapeutics, anticipated to close in Q1 2027.
• Secured a term loan agreement providing up to $150 million in non-dilutive capital to support operations and business development.
• The company believes it has sufficient resources to fund operations for at least twelve months from the issuance of the Form 10-Q.
• Conference call scheduled for November 12, 2026, at 8:30 a.m. Eastern Time to discuss results.