CorMedix Inc. Announces Preliminary Fourth Quarter 2024 Results and Provides Business Update

Rhea-AI Summary

CorMedix (NASDAQ: CRMD) reports strong preliminary Q4 2024 results with unaudited net revenue of approximately $31 million and full-year 2024 revenue of $43 million. Q4 adjusted EBITDA is expected to exceed $12 million, achieving the company's breakeven target by year-end 2024.

The company has secured over $25 million in open purchase orders for Q1 2025 delivery and is actively shipping DefenCath to three midsized dialysis operators. CorMedix plans to expand into the inpatient hospital segment in Q1 2025 through a partnership with Syneos Health for dedicated sales team deployment. The company projects FY 2025 operating expenses of $72-78 million, with increased R&D spending for clinical initiatives.

As of December 31, 2024, CorMedix maintains a strong financial position with approximately $52 million in cash and short-term investments.

Positive

• Q4 2024 revenue reached $31 million with full-year revenue of $43 million
• Q4 adjusted EBITDA exceeded $12 million, achieving breakeven target
• $25 million in confirmed purchase orders for Q1 2025
• Strong cash position of $52 million as of December 31, 2024
• Successful implementation with three MDO customers with increasing order sizes

Negative

• Projected increase in operating expenses to $72-78 million for FY 2025
• Restructuring of field team with role eliminations due to sales force reorganization

Insights

Financial Analyst

The Q4 2024 results showcase remarkable financial performance with $31M quarterly revenue and $43M annual revenue, alongside adjusted EBITDA exceeding $12M. This marks a pivotal transition to profitability, notably achieving breakeven ahead of schedule. The $25M in open purchase orders for Q1 2025 indicates strong demand momentum. Cost management appears strategic, with the Syneos Health partnership structured to be cost-neutral while expanding market reach. The $52M cash position provides adequate runway for planned clinical initiatives and commercial expansion. The projected FY 2025 operating expenses of $72-78M reflect calculated investment in growth, primarily through R&D. The successful penetration of the MDO market and planned expansion into LDO segment targeting 4,000 patients demonstrates effective market strategy execution.

Market Research Analyst

DefenCath's commercial trajectory shows strong market acceptance, particularly in the dialysis sector. The expansion strategy into three distinct channels - MDOs, LDOs and hospitals - creates multiple growth vectors. The planned LDO implementation targeting 4,000 patients represents significant revenue potential given the high-value nature of the product. The strategic pivot to create a dedicated inpatient sales force through Syneos Health indicates market opportunity beyond the initial dialysis focus. The expansion into Total Parenteral Nutrition (TPN) and pediatric applications could substantially broaden the addressable market. Early success with MDOs and increasing order sizes suggest positive product reception and potential for accelerated adoption across the healthcare system.

Medical Research Analyst

The advancement of clinical initiatives, including the TPN study protocol submission and planned pediatric trials, demonstrates strategic pipeline expansion. These studies could significantly broaden DefenCath's therapeutic applications beyond its current hemodialysis catheter indication. The pediatric study particularly addresses an underserved market with high unmet needs. The commercial success in the adult dialysis market provides validation for the technology's efficacy and safety profile, which could accelerate adoption in new indications. The reorganization of the sales force shows commitment to specialized market approach, important for medical device adoption in different healthcare settings.

‒ Q4 2024 Unaudited Net Revenue of Approximately $31mm ‒

‒ FY 2024 Unaudited Net Revenue of Approximately $43mm ‒

‒ Expects Q4 Adjusted EBITDA to Exceed $12mm ‒

BERKELEY HEIGHTS, N.J., Jan. 07, 2025 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announces its preliminary unaudited fourth quarter results and provides an update on its business. These include the following key updates:

• CorMedix announces preliminary, unaudited net revenue of approximately $31mm for Q4 2024 and approximately $43mm for FY 2024, and expects Q4 2024 adjusted EBITDA⁽¹⁾ to exceed $12mm.
  
  
• The Company is shipping DefenCath to all three of its midsized dialysis operator (MDO) customers and has seen continuous ordering of increasing size throughout the quarter. CorMedix has more than $25mm of existing open purchase orders scheduled for delivery during the first quarter of 2025.
  
  
• The CorMedix team is actively working with its Large Dialysis Operator (LDO) customer to begin DefenCath implementation in the first half of 2025, and hopes to achieve the LDO’s targeted patient utilization of 4,000 patients in H2 2025.
  
  
• The Company today announces an expanded deployment effort in the inpatient hospital segment beginning in Q1 2025. The Company has engaged Syneos Health to build a dedicated inpatient field sales team that will exclusively promote DefenCath to hospitals and health systems. As part of this expanded inpatient deployment, the current field team which was covering both inpatient and outpatient segments is being reorganized, with existing field roles being transitioned or eliminated.
  
  
• A final clinical study protocol for DefenCath in Total Parenteral Nutrition (TPN) was submitted to FDA in Q4, and study enrollment is expected to begin in H1 2025. The Company also expects patient enrollment in the pediatric study for DefenCath in pediatric hemodialysis to begin in H2 2025.
  
  
• CorMedix estimates the expanded inpatient deployment and internal commercial realignment to be cost neutral on overall S&M expense in 2025, and announces preliminary operating expense guidance for FY 2025 of $72 – $78mm, excluding non-cash and one-time items, with the increase over 2024 spending levels largely driven by R&D spending on previously announced clinical initiatives.
  
  
• The Company reports preliminary unaudited cash and short-term investments, as of December 31, 2024, of approximately $52 million.
  

Joe Todisco, CorMedix CEO, commented, “I’m proud to announce our preliminary Q4 results today, including surpassing our guidance of becoming breakeven by year-end 2024. CorMedix continues to execute well on our key objectives particularly around our outpatient launch, and I am pleased with the implementation efforts we have seen thus far from key customers in the outpatient segment. Today’s announcement of our agreement for inpatient expansion with Syneos Health reinforces our commitment to grow DefenCath across settings of care. I believe we begin 2025 in a strong position and look forward to updating investors as we continue to execute over the months ahead.”

The preliminary financial information presented in this press release is based on CorMedix’s current expectations and may be adjusted as a result of, among other things, the completion of our internal review process and the completion of customary annual audit procedures.

(1) Adjusted EBITDA is a non-GAAP financial measure and excludes non-cash items such as stock based compensation and certain non-recurring items. The Company expects to provide a reconciliation of Adjusted EBITDA to the most comparable GAAP measure in its earnings release relating to the fourth quarter and full year 2024 financial results. Such reconciliation is not included in this release because we are currently finalizing certain amounts that would be required to be included in the U.S. GAAP measure or the individual adjustments for such reconciliation.

About CorMedix

CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. The Company is focused on commercializing its lead product DefenCath^® (taurolidine and heparin) which was approved by the FDA on November 15, 2023. CorMedix commercially launched DefenCath in inpatient settings in April 2024 and in outpatient settings in July 2024. CorMedix is commencing clinical studies in adult Total Parenteral Nutrition (TPN) patients and pediatric hemodialysis (HD) patient populations in 2025 and also intends to develop DefenCath as a catheter lock solution for use in other therapeutic areas. For more information visit: www.cormedix.com.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are subject to risks and uncertainties, including expectations regarding CorMedix’s fourth quarter and full year 2024 unaudited net revenue, fourth quarter 2024 adjusted EBITDA, cash and short-term investments as of December 31, 2024 and preliminary operating expense guidance for fiscal year 2025; the timing of expected achievement of the LDO’s targeted patient utilization; the timing of expected study enrollment for a final clinical study protocol for DefenCath in TPN; and the timing of expected patient enrollment in a pediatric study for DefenCath in pediatric hemodialysis. Forward-looking statements are often identified by the use of words such as, but not limited to, “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “will,” “plan,” “project,” “seek,” “should,” “target,” “will,” “would,” and similar expressions or variations intended to identify forward-looking statements. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects should be considered forward-looking statements. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, and readers are directed to the Risk Factors identified in CorMedix’s filings with the SEC, including its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q, copies of which are available free of charge at the SEC’s website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and such forward-looking statements speak only as of the date of this press release. Investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law.

Investor Contact:
Dan Ferry
Managing Director
LifeSci Advisors
daniel@lifesciadvisors.com
(617) 430-7576

FAQ

What was CorMedix (CRMD) Q4 2024 revenue?

CorMedix reported preliminary unaudited Q4 2024 revenue of approximately $31 million.

How much cash does CorMedix (CRMD) have as of December 2024?

CorMedix reported approximately $52 million in cash and short-term investments as of December 31, 2024.

What are CorMedix's (CRMD) projected operating expenses for 2025?

CorMedix projects operating expenses of $72-78 million for FY 2025, excluding non-cash and one-time items.

What is the value of CorMedix's (CRMD) open purchase orders for Q1 2025?

CorMedix has over $25 million in existing open purchase orders scheduled for Q1 2025 delivery.

When will CorMedix (CRMD) begin DefenCath implementation with Large Dialysis Operators?

CorMedix plans to begin DefenCath implementation with its LDO customer in the first half of 2025.