CorMedix (CRMD) shares are +82% in 2024 trading to the highest level since 2022 with a big flag breakout this week following unusual opening buys of 7500 ITM March $3 calls, a current position valued at $3M.

CRMD is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening diseases and conditions.  Its primary focus is on the commercialization of our lead product, DefenCath^® in the United States.  DefenCath is an antimicrobial catheter lock solution indicated to reduce the incidence of catheter-related bloodstream infections  in adult patients with kidney failure receiving chronic hemodialysis through a central venous catheter. It is indicated for use in a limited and specific population of patients. CRBSIs can lead to treatment delays and increased costs to the healthcare system when they occur due to hospitalizations, need for IV antibiotic treatment, long-term anticoagulation therapy, removal/replacement of the CVC, related treatment costs, as well as increased mortality.

DefenCath is the first and only FDA-approved antimicrobial CLS in the U.S. and was shown to reduce the risk of CRBSI by up to 71% in a Phase 3 clinical study. On January 25, 2024, CMS determined that DefenCath should be classified as a renal dialysis service that is subject to the Medicare end-stage renal disease prospective payment system.

The total annual cost for treating CRBSI episodes and their related complications in the U.S. is up to $2.3 billion, with approximately 250,000 CRBSI episodes per year (Becker’s Hospital Review). According to the 2022 United States Renal Disease System, reporting data from 2020, there were nearly 808,000 End-Stage-Renal-Disease, or ESRD, patients on permanent hemodialysis in the U.S. Of these, nearly 108,000 hemodialysis patients were new patients diagnosed with ESRD during the year they were receiving dialysis through a CVC.

CRMD has a market cap of $383M and trades 8.4X Cash with revenue estimates for FY28 at $340M, putting shares just over 1X FY28 sales. Short interest is high at 18.5% of the float. CRMD earlier this week entered a multi-year commercial supply contract for the supply of DefenCathto its facilities in the US. CorMedix commenced the inpatient launch of DefenCath on April 15 and commenced the outpatient launch during the first week of July. CRMD expects inpatient sales to begin to ramp in the fourth quarter as DefenCath is reviewed, added to formulary and adopted into hospital workflows for patient use.

Defencath has the potential to become the standard of care across dialysis procedures and CRMD will have outpatient results showing up starting in Q3 results. Medicare Advantage, comprising an additional 45% of ESRD patients, remains an opportunity for growth and expansion for the DefenCath reimbursement and would be a major stock catalyst if accepted.

CRMD is also starting patient enrollment in the first quarter of 2025 for adult Total Parenteral Nutrition, or TPN, and there emains a significant unmet medical need in this patient population, with up to 26% of TPN patients having a catheter-related infection, and those patients having increased morbidity and mortality rates. Market research estimates that the addressable market opportunity in TPN is approximately 4.7 million TPN infusions per year.  The company’s goal is to obtain FDA approval for an expanded use of our taurolidine and heparin catheter lock solution in TPN in the 2027 to 2028 timeframe and estimates annual peak sales potential in this indication to be in the range of $150 million to $200 million, incrementally beyond hemodialysis.