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1. Like **BD (Becton, Dickinson and Company)**, but focused specifically on preventing central line infections.

2. A specialized biopharma company, similar to **Jazz Pharmaceuticals**, but focused on preventing serious hospital infections.

3. Like **Fresenius Medical Care**, but focused specifically on preventing catheter infections in dialysis patients.

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• DefenCath (taurolidine/heparin solution): An investigational antimicrobial and anticoagulant solution designed to prevent catheter-related bloodstream infections (CRBSIs) in patients undergoing hemodialysis via a central venous catheter.

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Cormedix (symbol: CRMD) sells primarily to other companies within the healthcare sector. Their flagship product, DefenCath™, is an antimicrobial and anticoagulant solution used to reduce catheter-related bloodstream infections in adult hemodialysis patients with a central venous catheter. Cormedix's sales efforts are focused on directly selling this product to healthcare institutions.

The major categories of customer companies that Cormedix targets and serves include:

• Integrated Delivery Networks (IDNs): These are large, integrated healthcare systems that encompass multiple hospitals, clinics, and other care facilities. They represent a significant portion of the U.S. healthcare market and often have centralized purchasing. Prominent public examples of such systems that would be key targets for Cormedix include:

  • HCA Healthcare (Symbol: HCA)
  • Tenet Healthcare (Symbol: THC)
  • Universal Health Services (Symbol: UHS)

• Dialysis Center Chains: Given that DefenCath is specifically indicated for patients undergoing chronic hemodialysis, specialized dialysis centers are primary customers. Major public companies operating extensive chains of dialysis centers that would be targeted by Cormedix include:

  • Fresenius Medical Care (Symbol: FMS)
  • DaVita Inc. (Symbol: DVA)

• Standalone Hospitals and Regional Hospital Systems: Individual hospitals or smaller regional groups of hospitals also directly purchase and administer medical products like DefenCath. While many are privately held, these entities collectively form a significant part of the customer base for specialized pharmaceutical products.

Please note: Cormedix commercially launched DefenCath in July 2023. As of their latest public filings, specific major customers (e.g., accounting for 10% or more of total revenue) have not been individually disclosed. The companies listed above are prominent examples within the categories of healthcare organizations that Cormedix targets and serves as its primary customers.

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• STC Biologics LLC
• ChemPacific Corporation
• Baxter International Inc. (Symbol: BAX)

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Joseph Todisco, Chief Executive Officer

Prior to joining CorMedix, Mr. Todisco spent eleven years in various roles at Amneal Pharmaceuticals, including Chief Commercial Officer of Amneal Specialty, and Senior Vice President Corporate Development & International Operations. He was also co-founder and formerly chief executive of Gemini Laboratories LLC, a specialty pharmaceutical company that was subsequently acquired by Amneal in 2018. Before Amneal, he led Ranbaxy Pharmaceutical's North American Commercial Strategy and Business Development for over five years and held various leadership roles with Par Pharmaceuticals.

Susan Blum, EVP & Chief Financial Officer

Ms. Blum joined Melinta Therapeutics in 2016 and served as CFO from April 2021 until August 2025, at which time she assumed the role of CFO for CorMedix in connection with the merger of the companies. She has over 25 years of experience in both public and private companies, with expertise in strategic planning, risk management, and financial operations. Before Melinta, Ms. Blum held leadership positions within corporate controllership and financial reporting at Textura Corporation (now Oracle), Orbitz Worldwide (now Expedia), and PDL BioPharma and Facet Therapeutics (now Abbott), where she played key roles in public offerings, mergers, acquisitions, and other strategic transactions. In April 2024, she was appointed to the Board of Directors and Audit Committee Chair for BiomX.

Matt David, M.D., EVP & Chief Business Officer

Dr. David was appointed Executive Vice President and Chief Business Officer in August 2025. He previously served as CorMedix's CFO from May 2020 to August 2025 and as interim CEO from October 2021 to May 2022. He leads the company's corporate development, capital markets, and investor relations activities. Prior to joining CorMedix, Dr. David was Head of Strategy at Ovid Therapeutics and spent the majority of his career in healthcare investment banking roles, advising life sciences companies on a broad range of financing and strategic transactions.

Beth Zelnick Kaufman, Esq., EVP, Chief Legal and Compliance Officer, and Corporate Secretary

Ms. Zelnick Kaufman was appointed in December 2023 and leads the company's legal and compliance activities. Prior to CorMedix, she served as Chief Legal and Administrative Officer and Corporate Secretary of Akorn Pharmaceuticals. She also held roles as Chief Legal Officer of The Broad Institute of MIT & Harvard and several positions at Amneal Pharmaceuticals, including Assistant General Counsel, Vice President, Legal Affairs, and Head of Government Affairs.

Liz Hurlburt, EVP, Chief Operating Officer

Ms. Hurlburt oversees Alliance Management, Clinical Development, Medical Affairs, Quality, Supply Chain, and Technical Operations, and also serves as Chief Integration Officer. She was most recently the EVP, Clinical Strategy and Operations for CorMedix. Over the past twenty years, she has held various progressive management roles in clinical operations and strategic turnarounds at Gemphire Therapeutics and Accelovance, and founded Clinical Minds, LLC, a specialty consulting group.

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The key risks to CorMedix's business (CRMD) primarily revolve around the commercial viability of its flagship product, DefenCath, compounded by competitive pressures and manufacturing dependencies.

1. Commercialization Challenges and Market Limitations of DefenCath: CorMedix's business is highly dependent on the successful commercialization and widespread adoption of DefenCath, its primary revenue-generating product. The market for DefenCath is specific to adult patients with kidney failure receiving chronic hemodialysis through a central venous catheter, which represents a niche population. Early revenues for DefenCath may reflect initial inventory building rather than sustained utilization patterns. A significant risk is the impending expiration of special reimbursements, such as the Transitional Pass-Through Payment (TDAPA), which currently boosts profits but whose cessation will threaten future margins and pricing power. Furthermore, there are concerns about potential inventory adjustments and price erosion in the market, and the company has provided limited revenue visibility beyond the first half of 2025. Prescribers may also be hesitant to "overprescribe" antimicrobial drugs due to efforts to combat antibiotic resistance, potentially limiting DefenCath's widespread adoption.
2. Competition in the Catheter Lock Solution Market: Although DefenCath holds a first-mover advantage as the first and only FDA-approved antimicrobial catheter lock solution in the U.S. for its specific indication, the broader competitive landscape poses a significant threat. Larger pharmaceutical companies, including Pfizer, Amphastar Pharmaceuticals, B. Braun, Baxter, and Fresenius Kabi USA, already market various heparin-based products and possess stronger pipelines, larger manufacturing capabilities, and greater financial resources. These established players could potentially expand their focus to target catheter-related bloodstream infection (CRBSI) prevention, which could challenge CorMedix's market advantage and affect its long-term growth outlook.
3. Regulatory and Manufacturing Dependencies: CorMedix has faced historical regulatory hurdles related to DefenCath, including Complete Response Letters (CRLs) from the FDA concerning deficiencies at third-party manufacturing facilities and with its heparin supplier. While DefenCath ultimately received FDA approval, the company's continued reliance on third-party contract manufacturers for production introduces inherent risks related to supply chain vulnerabilities, potential production bottlenecks, and ongoing regulatory compliance. Any future manufacturing issues or regulatory scrutiny could impact the availability and commercialization of DefenCath. Additionally, future efforts to expand DefenCath's label to other indications, such as total parenteral nutrition, will be subject to further clinical and regulatory hurdles.

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CorMedix Inc. (CRMD) primarily focuses on its lead product, DefenCath, an antimicrobial catheter lock solution. This product is designed to reduce the incidence of catheter-related bloodstream infections (CRBSI) in adult patients with kidney failure who receive chronic hemodialysis through a central venous catheter.

The addressable markets for DefenCath are as follows:

• Catheter-Related Bloodstream Infection (CRBSI) Prevention in Hemodialysis: The U.S. addressable market for catheter-lock solutions in the hemodialysis setting is approximately 80 million catheter lumen locks per year. Globally, the catheter-related bloodstream infection market was valued at approximately USD 1.53 billion in 2023 and is projected to reach around USD 2.52 billion by 2033, growing at a Compound Annual Growth Rate (CAGR) of 5.13% from 2024 to 2033. Another estimate projects this market to grow from USD 1.69 billion in 2025 to USD 2.65 billion by 2034, at a CAGR of 5.13%. North America is noted to hold a significant share of this market.
• CRBSI Prevention in Adult Total Parenteral Nutrition (TPN) Patients: CorMedix is pursuing an expanded indication for DefenCath in adult TPN patients. The total addressable market for DefenCath in TPN is driven by an estimated 5 million infusions per year in the U.S. The U.S. addressable market for catheter lock solutions in oncology/TPN is approximately 150 million catheter lumen locks per year. One analyst estimates peak DefenCath sales in TPN could reach $150–$200 million.
• CRBSI Prevention in Pediatric Hemodialysis Patients: CorMedix also plans to conduct a study for DefenCath in pediatric hemodialysis patients. Market size for this specific population was not explicitly detailed in the search results.

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• Increasing Market Penetration and Utilization of DefenCath: Following its FDA approval in November 2023, DefenCath, the first and only FDA-approved antimicrobial catheter lock solution to reduce catheter-related bloodstream infections (CRBSIs) in adult hemodialysis patients, commenced inpatient commercialization in April 2024 and outpatient commercialization in July 2024. The company has reported strong market adoption, with significant revenue contributions driven by increased utilization from large dialysis organizations (LDOs) and continued uptake across its broader customer base, including smaller outpatient dialysis operators and inpatient hospitals. CorMedix's full-year 2025 pro forma net revenue guidance was raised to at least $375 million, with DefenCath sales exceeding $85 million in Q3 2025, underscoring its strong growth trajectory.
• Expansion of DefenCath into New Patient Populations: CorMedix plans to develop DefenCath as a catheter lock solution for use in other patient populations beyond adult hemodialysis, which represents a significant opportunity to broaden its addressable market and generate additional revenue streams.
• Revenue Contribution from the Melinta Therapeutics Acquisition: The acquisition of Melinta Therapeutics in August 2025 has diversified CorMedix's product portfolio with seven additional approved therapies. This new portfolio is projected to contribute between $125 million and $135 million in revenues in 2025, providing a substantial incremental revenue stream and helping to smooth quarterly revenue volatility.
• Potential Launch and Uptake of Rezzayo for Fungal Infection Prophylaxis: Included in the Melinta acquisition, Rezzayo is currently in a Phase III clinical trial (ReSPECT study) for the prophylaxis of fungal infection in adult patients undergoing allogeneic blood and marrow transplant. Clinical data for this study is anticipated in the second quarter of 2026, and CorMedix believes this indication represents a potential market opportunity of over $2 billion, which could become a significant revenue driver upon approval and commercialization.

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Share Issuance

• CorMedix announced a proposed underwritten public offering of $85.0 million of common stock on June 26, 2025.
• The company intends to use the net proceeds from this offering for general corporate purposes, including working capital, research and development expenses, and potential strategic transactions such as acquisitions, joint ventures, or collaborations.
• This public offering included granting underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock.

Outbound Investments

• In August 2025, CorMedix announced the acquisition of Melinta Therapeutics LLC, which is expected to be accretive to earnings per share starting in 2026.
• CorMedix made a strategic minority investment of $5 million in Talphera in September 2025.
• This investment in Talphera grants CorMedix an exclusive right of first negotiation to acquire Talphera after the Phase 3 results for its lead candidate Niyad are announced.