CorMedix raises 2025 revenue guidance to $390M-$410M amid accelerated Melinta integration and DefenCath momentum

Earnings Call Insights: CorMedix Inc. (CRMD) Q3 2025

MANAGEMENT VIEW

* CEO Joseph Todisco highlighted the completion and rapid integration of the Melinta Therapeutics acquisition, describing it as "transformational for CorMedix creating a diversified specialty pharmaceutical company with a broad portfolio of commercial and late-stage pipeline products." He noted, "Integration of the legacy CorMedix and Melinta operations has progressed faster than originally expected" and expects to capture approximately $30 million of the projected $35 million to $45 million in synergies before the end of 2025.
* Todisco announced the company will rebrand as CorMedix Therapeutics and adopt a new logo to unify the expanded organization. He stated, "This past quarter marks the most successful quarter from a financial perspective in company history, registering record levels for revenue of $104.3 million, net income of $108.6 million and adjusted EBITDA of $71.8 million."
* The CEO also revealed a strategic minority investment in Talphera Inc., providing a right-of-first negotiation to acquire the company after Phase III results in 2026.
* Todisco emphasized upcoming catalysts, including top-line data for Rezzayo in Q2 2026 and the anticipated expansion of DefenCath into the TPN market, with a total addressable market of up to $750 million and Phase III completion expected by end of 2026 or early 2027.
* CFO Susan Blum stated, "For the third quarter, net revenue was $104.3 million, including the DefenCath sales of $88.8 million, representing a total net revenue increase of $77.5 million year-over-year."
* Blum added, "Operating expenses for the third quarter were $42.6 million compared to $14.1 million for CorMedix on a stand-alone basis in the same quarter last year. The increase...includes nonrecurring costs of $12.7 million associated with the transaction and integration as well as severance costs associated with the Melinta acquisition."
* Blum highlighted, "Overall, for the third quarter of 2025, we achieved net income of $108.6 million or $1.26 per diluted share marking meaningful progress compared to the third quarter of 2024."

OUTLOOK

* Management raised full year revenue guidance from a minimum of $375 million to a range of $390 million to $410 million. Pro forma fully synergized adjusted EBITDA for 2025 is now guided to $220 million to $240 million, up from a previous range of $165 million to $185 million.
* The company guides to fourth quarter net revenue in the range of $115 million to $135 million, driven by continued DefenCath momentum and a full quarter from Melinta. Management stated, "We anticipate ending the year with approximately $100 million of cash and cash equivalents, supported by ongoing positive operating cash flow and working capital optimization."

FINANCIAL RESULTS

* Net revenue for Q3 2025 was $104.3 million, with $88.8 million from DefenCath sales and approximately $15.5 million from Melinta, which includes $12.8 million from Melinta portfolio sales.
* Adjusted EBITDA for Q3 was $71.8 million, up from a loss of $2 million in Q3 2024.
* Net income for the quarter was $108.6 million, including a $59.7 million tax benefit from the realization of deferred tax assets.
* The company ended the quarter with $55.7 million in cash, cash equivalents, and short-term investments.

Q&A

* Leszek Sulewski, Truist: Questioned DefenCath inventory stocking, seasonality, and revenue cadence. CEO Todisco responded that "our smaller customers...are holding on average about 2 to 3 weeks on hand. The LDO is somewhere between 3 to 4 weeks," and noted no significant Q3 stocking. He remarked on the lack of seasonality in both DefenCath and Melinta portfolios and emphasized ongoing growth opportunities post-TDAPA, particularly with Medicare Advantage.
* Jason Butler, Citizens: Asked about LDO utilization and real-world data. Todisco stated, "utilization is also faster than what we expected in the ramp," exceeding the previously targeted 6,000 patients, but did not provide an exact number. EVP Hurlburt added that year 1 real-world evidence would include about 2,000 patients and expects to present data within 6-7 weeks.
* Roanna Ruiz, Leerink Partners: Queried revenue and pricing dynamics post-TDAPA. Todisco explained, "we do know there's going to be price compression...but the pushes and pulls would be related to how CMS does the calculation for utilization."
* Brandon Folkes, H.C. Wainwright: Asked about inpatient DefenCath and Talphera/Niyad. Todisco said, "on the inpatient side...we've seen good progress...As Liz mentioned...starting next year...we'll be training that team in December...In January, they'll begin promoting in the inpatient segment."
* Serge Belanger, Needham: Inquired about DefenCath pricing and legislative changes. Todisco affirmed, "there is a slight erosion based on the structure of the agreements...volume has obviously grown significantly to more than offset the changes in price." He described pending legislation that could alter TDAPA reimbursement.
* Daniel Ferry, LifeSci Advisors: Asked about investor perception of the Melinta deal. Todisco stated, "I certainly do think there's a lot of things that are not currently being appreciated, one of which is the stabilizing factor of the base business...Rezzayo prophylaxis as a pipeline opportunity is certainly not being valued appropriately."

SENTIMENT ANALYSIS

* Analysts pressed for detailed clarity on post-TDAPA pricing, utilization, and the impact of the Melinta acquisition, demonstrating a slightly positive but vigilant tone focused on risk factors and future growth levers.
* Management maintained a confident and optimistic tone throughout, frequently highlighting record performance and integration success, and using phrases such as "I am excited about the future" and "We remain confident in the outlook for the remainder of this year and the path to sustained growth and profitability."
* Compared to the previous quarter, management's confidence has increased, shifting from transaction anticipation to execution and integration, while analysts remain focused on execution risks and financial sustainability.

QUARTER-OVER-QUARTER COMPARISON

* Guidance for full-year revenue was raised from $305-$335 million previously to $390-$410 million, while adjusted EBITDA guidance increased from $150-$170 million to $220-$240 million.
* The Melinta acquisition moved from announcement to completion, with integration progressing ahead of expectations.
* Analysts in both quarters focused on DefenCath ramp, Melinta synergies, and post-TDAPA dynamics, but Q3 included more granular questions on pricing, reimbursement, and the contribution of new assets.
* Management tone in Q3 was more assertive and forward-looking, emphasizing financial strength and new growth drivers, while the previous quarter was more cautious pending acquisition closure.
* Key metrics such as revenue, net income, and EBITDA improved materially quarter-over-quarter, reflecting the impact of both organic growth and the Melinta transaction.

RISKS AND CONCERNS

* Management identified potential price compression for DefenCath post-TDAPA as a significant risk, contingent on CMS rulings.
* Uncertainty remains regarding the outcome and timing of the ESRD final rule, which could impact pricing in Q3/Q4 2026 and 2027.
* Pending legislation could affect reimbursement structures and market expansion opportunities.
* Integration of Melinta presents operational risks, though management reported faster-than-expected progress and significant synergy capture.
* Analysts highlighted concerns around DefenCath's future revenue trajectory, Medicare Advantage penetration, and the market's perception of the Melinta deal value.

FINAL TAKEAWAY

CorMedix delivered a record financial quarter, completed the transformative Melinta Therapeutics acquisition, and executed rapid integration with substantial synergy realization. The company raised its 2025 revenue and adjusted EBITDA guidance, driven by stronger-than-expected product adoption and a broadened portfolio. Management remains focused on maximizing post-TDAPA value for DefenCath, leveraging upcoming clinical data for Rezzayo and TPN, and capitalizing on new market opportunities while closely monitoring regulatory and reimbursement developments that could impact future performance.

Read the full Earnings Call Transcript [https://seekingalpha.com/symbol/crmd/earnings/transcripts]

MORE ON CORMEDIX

* CorMedix Inc. (CRMD) Q3 2025 Earnings Call Transcript [https://seekingalpha.com/article/4842516-cormedix-inc-crmd-q3-2025-earnings-call-transcript]
* CorMedix: Strong Buy After Strong Developments And A Strategy Before Earnings [https://seekingalpha.com/article/4832903-cormedix-strong-buy-after-strong-developments-strategy-before-earnings]
* CorMedix: Challenging Long-Term Risk-Reward, Maintain Sell [https://seekingalpha.com/article/4828994-cormedix-stock-challenging-long-term-risk-reward-maintain-sell]
* CorMedix GAAP EPS of $1.26 beats by $0.63, revenue of $104.28M beats by $18.26M [https://seekingalpha.com/news/4520415-cormedix-gaap-eps-of-1_26-beats-by-0_63-revenue-of-104_28m-beats-by-18_26m]
* CorMedix Q3 2025 Earnings Preview [https://seekingalpha.com/news/4520052-cormedix-q3-2025-earnings-preview]