Rockwell Medical (NASDAQ: RMTI) is a small-cap bio-pharmaceutical company with a core, growing business which manufactures, sells, and distributes dialysate (which remove toxins and wastes from the blood while replacing nutrients) products to patients with chronic kidney disease (CKD) and end-stage renal disease (ESRD) receiving dialysis (which is typically conducted three times per week). The Company has a 27% share of the U.S. dialysate market with three manufacturing plants and over 16.6 million treatments provided last year. RMTI also provides ancillary products to hemodialysis (HD) providers such as blood tubing, fistula needles, dressings, cleansing agents, filtration salts, and other supplies.
The Company's current line-up of dialysate products are designed to be the delivery vehicle for Soluble Ferric Pyrophosphate (SFP), which provides an opportunity for RMTI to expand upon its current market share by offering a value-added, high margin dialysate iron replacement therapy option for its customers while improving the clinical outcomes for anemic dialysis patients. The Company's core business includes the following: RenalPure (Liquid Acid and Powder Bicarbonate Concentrates), Dri-Sate (Dry Acid Concentrate and Mixing System), SteriLyte (Liquid Bicarbonate Concentrate), blood tubing sets, and fistula needles.
The Company has a total of three manufacturing facilities and also has a delivery/transportation subsidiary, Rockwell Transportation, Inc. Rockwell Medical was founded in 1995 by Robert Chioini, who serves as the current CEO, President and Chairman of the Company. Rockwell Medical was incorporated in 1996 and went public in 1998.
RMTI supplies products and services for the kidney disease and dialysis market, which is dominated by DaVita (NYSE:DVA) and Fresenius Medical (NYSE:FMS). The Company's reach includes 37 states and foreign countries located in Latin America, Asia, and Europe. The three major dialysis markets include the U.S., E.U., and Japan, which account for about 55-60% of treatments on a global basis.
An estimated 19.2 million in the U.S. have CKD, which is a progressive loss of renal function that is divided into five stages with ESRD representing the irreversible loss of kidney function which requires patients to receive dialysis to survive - making it the ultimate recession-proof business. Stage 5 CKD affects an estimated 395,000 patients in the U.S. and 2 million worldwide while 8.1 million people in the U.S. are estimated to have Stages 3 or 4 CKD.
The U.S. market for IV iron replacement therapy is estimated at $500 million per year while the global market is about $850 million. SFP is a unique, water soluble form of iron which bypasses the liver and results in higher absorption to maintain normal iron/hemoglobin levels and replace the iron that is lost through dialysis. SFP is distributed directly into the blood so that the iron uptake occurs naturally at the cellular level. Because SFP is designed to be administered with dialysis, it complements the Company's existing product line-up and is convenient to ESRD patients who must undergo dialysis on a regular basis.
Currently marketed IV iron replacement therapies are processed through the liver, which results in variable and delayed processing of the iron in order to deliver it in a useful form to the body. SFP (dialysate iron) is differentiated from IV iron therapies because it is delivered directly in a useable form through dialysis and can be used by the bone marrow to produce new red blood cells while maintaining a steady, normal level of hemoglobin and iron. By maintaining a constant iron balance, SFP maximizes the creation of red blood cells, the generation of hemoglobin, optimizes the treatment response of EPO. Also, oxidative stress on the liver is avoided since SFP bypasses this route of processing and about 2,000 human doses of SFP have been administered with no safety concerns arising to date.
RMTI is now focused on obtaining approval for its lead drug candidate, Soluble Ferric Pyrophosphate (SFP), for delivery through dialysate, but are also evaluating SFP extensions into other applications as well as other technologies with the help of two new positions mentioned earlier for VP of Clinical Development/Medical Affairs and Chief Scientific Officer. RMTI expects to spend about $2.5-$3.5 million during 2H09 to complete the ongoing Phase 2b trial of SFP in order to obtain FDA approval for a pivotal Phase 3 trial. The Company expects to begin the Phase 3 trial by mid-2010 at an estimated cost of $15 million, depending on the details of the trial design such as duration and number of subjects being evaluated.