The Company came public in March of this year with Maxim Group being the company's underwriter. Since then, the share price has drifted lower while the company has continued to execute on its business plan. With a market capitalization of $16 million and a balance sheet reflecting $10.5 million in cash (as of October 14, 2010), CorMedix has two lead product candidates entering late stage clinical development.
- The first is Neutrolin for the prevention of central venous catheter (CVC) infection and clotting from hemodialysis.
- The second is Deferiprone for the prevention of contrast induced nephropathy (CIN) in high-risk patients.
When evaluating biotechnology and pharmaceutical companies, it is often challenging trying to handicap the risk. As with any developmental stage company in this space these risks include having adequate capital, clinical studies/trial risk and finally the FDA approval process. However, in CorMedix's case, the company has stated that the capital raised in its March, 2010 IPO provides it with sufficient cash to meet its operating requirements through the end of the first quarter of 2012.
With regard to the lead drug candidates, Neutrolin and Deferiprone, there is reduced development risk and reduced regulatory risk. This is something always appealing to the investment community. Neutrolin has had a successful U.S. Pilot study already completed and there is established use in the EU markets. With regard to Deferiprone, it is available in the US and 49 additional countries, albeit for different indications. This can often mean an easier path to final approval because the company is merely establishing efficacy with a drug already on the market but for a different medical condition. CorMedix is using a proprietary formulation of Deferiprone. Also, the company notes that Deferiprone has an approved regulatory path with special protocol assessment (SPA) with the FDA. Simply put, an SPA is a declaration from the FDA that an uncompleted clinical trial design, clinical endpoint and statistical analyses are acceptable for FDA approval. Finally, CorMedix has worldwide commercialization rights for the drugs.
Large Addressable Market
In the US alone, there are 80,000 patients who in aggregate undergo 12.5 million hemodialysis sessions per year. There are approximately 160,000 episodes of catheter related bloodstream infections that directly result from the hemodialysis process. An astounding 6,000 people die from this annually. Preventing this catheter related infection is currently an unmet need. CorMedix is working to ultimately bring Neutrolin to market to meet this meet this need.
Cormedix' other lead product is a proprietary formulation of Deferiprone to be used in the prevention of Contrast Induced Nephropathy or CIN. CIN is the 3rd most common cause of hospital acquired renal insufficiency. CIN causes not only major kidney damage but can lead to severe illness and death. This too represents an unmet need as there are currently no FDA approved drugs on the market to treat or prevent CIN.
Cardiac and Renal diseases are getting a lot of press. The problem seems to only be growing. An interesting article on page D1 of the Wall Street Journal on October 5, 2010 entitled, "A Dialysis Treatment For the Busy Patient," is a must read. It discusses how more and more of the 380,000 Americans on dialysis are opting for home hemodialysis. Currently on 50% of the nation's 5,000 dialysis centers offer home treatment options.