Rockwell Medical's (NASDAQ:RMTI) soluble ferric pyrophosphate (SFP) or Triferic drug, currently under phase III development, is a game-changer. It is set to become the standard of care for iron replacement therapy in end-stage renal disease (ESRD) patients on dialysis treatment, a $600 mill. market in the U.S. alone, and over $1 bill. worldwide. Furthermore, the market demand has excellent growth characteristics, with the number of dialysis patients in the U.S. alone expected to rise to almost five-fold from 0.44 mill. to over 2 mill. patients by 2030, at a 8% to 9% CAGR, primarily due to an aging population and increased prevalence of type 2 diabetes. The long-term worldwide opportunity is also promising given that there are about 2.3 mill. dialysis patients worldwide, about five times that in the U.S.
While RMTI shares are up 50% year-to-date (YTD), the current $500 mill. market-cap severely undervalues the long-term opportunity. Simply put, in Triferic, you have an iron replacement therapy where the interests of patients, providers, insurance companies, and the government intersect, a not-so-common feat in the world of healthcare. Dialysis patients would get a drug that is easy to administer and has a safety profile similar to that of placebo. This is especially significant given that current treatments are black-boxed with severe side effects including anaphylactic reactions that can cause death, cardiovascular conditions including heart attack, stroke and congestive heart failure, among others.
The government and insurance companies would benefit as Triferic, due to its mode of administration, has been demonstrated to reduce the use of erythropoietin stimulating agents (ESAs), that is given to dialysis patients to restore their ability to produce red blood cells, by 37.1%. Given that the ESA market in the U.S. alone is about $2 bill., with the worldwide market estimated at $5.5 bill., the savings in the U.S. alone would be over $700 mill, with the strong growth characteristics discussed
