Rockwell Medical is a BioPharmaceutical Company with increasing year to year revenues. Rockwell Medical has an established operating business and develop unique, proprietary renal drugs. They have 27% of the market share with regard to renal business.
2. 2 Safe Harbor Statement This presentation contains forward-looking statements. All statements, other than statements of historical facts, including, among others, statements regarding the Company’s future financial position, business strategy, projected levels of growth, projected costs and projected financing needs, are forward-looking statements. Those statements include statements regarding the intent, belief or current expectations of Rockwell Medical Technologies, Inc. and members of the Company’s management team, as well as the assumptions on which such statements are based, and generally are identified by the use of words such as “may,” “will,“ “seeks,” “anticipates,” “believes,” “estimates,” “expects,” “plans,” “intends,” “should” or similar expressions. Forward looking statements are not guarantees of future performance and involve risks and uncertainties that actual results may differ materially from those contemplated by such forward-looking statements. The company believes these forward-looking statements are reasonable; however, undue reliance should not be placed on any forward-looking statements, which are based on current expectations. All written and oral forward-looking statements attributable to the Company or persons acting on its behalf are qualified in their entirety by these cautionary statements. Further, forward-looking statements speak only as of the date they are made, and the Company undertakes no obligation to update or revise forward-looking statements to reflect changed assumptions, the occurrence of unanticipated events or changes to future operating results over time unless required by law.
5. 5 Corporate Summary Bio-pharmaceutical drug company with established operating business Development of unique, proprietary renal drugs Lead drug iron delivery via dialysate – new standard of care Expect superior patient outcomes vs. current therapies Women’s health, oncology and parenteral nutrition Strong, growing core operating renal business Broad distribution channel and manufacturing base 3 manufacturing plants; 27% U.S. market share Dialysate; removes toxins and replaces nutrients in blood Products needed to maintain human life Provided 16.6 million+ treatments in 2008
6. 6 Kidney Disease Market Chronic kidney disease (CKD) 19.2 million Progressive loss of renal function; 5-Stages End Stage Renal Disease (ESRD) – irreversible loss of kidney function need dialysis to live Stage 5 = 395,000 US patients; 2 million worldwide Stages 3 and 4 = 8.1 million US patients Steady, growing market unaffected by economies Causes Diabetes and obesity, CVD, hypertension, aging Current treatment options Dialysis: life-saving blood filtering treatment Kidney transplant
20. 10 SFP Advantages Physiological iron maintenance therapy Slow infusion (10-15 µg/dL iron dose) via dialysate during scheduled dialysis session; 3X per week; works like dietary iron Small dose replaces 5-7mg avg blood loss per session Maintains iron balance efficiently matches EPO and hemoglobin Superior safety benefits for patient + lowers provider cost Safely travels direct to bloodstream bypasses liver and avoids toxicity ~2000 Clinical Doses to Date No Adverse Reactions Significantly lowers IV iron administration costs eliminates needles, syringes and RN time Bundled reimbursement provides superior patient-outcome at lowest cost; significant EPO savings expected Market potential U.S. IV iron CKD $500 million ($430M+ ESRD) Global IV iron CKD $850 million U.S. dialysis concentrates $180 million
21. Maximizes Erythropoiesis By maintaining constant iron balance SFP maximizes creation of red blood cells, generation of hemoglobin and optimization of EPO treatment response 11
22. SFP vs IV IronHemodialysis Dependent Chronic kidney Disease (HDD-CKD) 12 * high molecular weight sugar molecules have been linked to anaphylactic reactions; not present in SFP
24. SFP Phase IIb Study Primary Endpoint: Drop in hemoglobin of 1 gm/dL or more and safety. Secondary Endpoints: Time taken to drop hemoglobin by 1 g/dL or more, increase in hemoglobin to more than 12.5 g/dL, reticulocyte hemoglobin, infection, iron transferred into the patient. Enrollment completed April 2009 Two positive Data Safety Monitoring Board (DSMB) reviews to date; validates SFP superior safety profile Expect data Q4 2009 / Q1 2010 14
25. SFP Commercial Launch: 2012 15 Strategy: Leverage captive client relationships and distribution channels for fast SFP penetration * Forecast
26. Intellectual Property Rockwell owns exclusive worldwide license Patents issued in U.S, Europe and Japan three largest ESRD markets in the world Iron delivery via dialysate in hemodialysis (HD) and peritoneal dialysis (PD) Composition of matter and method of delivery Patent expires 2021 (including 5 year Hatch-Waxman) Patent filed on SFP-GMP grade formulation To cover dialysis, oral OTC/Rx, TPN, Oncology, and other extensions 16
31. Investment OpportunityBio-Pharma transition Innovative, proprietary disruptive technology with lead-drug candidate SFP Safer, more effective and substantial cost savings Significant market potential $500M U.S. / $850M Global Ready-made commercial distribution channel for fast market penetration of high-margin renal drugs Solid customer base; $51.6M revenues in 2008 Captive 35% market share to leverage ($88M) in 2011* Regulatory development progressing Ongoing Phase IIb FDA study / NIH funded study Phase III study anticipated to begin enrollment Q2 2010 FDA approval and commercial launch anticipated 2011/2012 *Forecast 21
32. Investment OpportunityBio-Pharma transition Strong scientific clinical team; focus SFP success; leverage renal drug pipeline Expanded SAB with 3 new anemia/iron deficiency experts Hired VP of Drug Development and Medical Affairs Hired Chief Scientific Officer SFP formulation opportunity – leveraging into new markets Secured other proprietary renal drugs Favorable environment for bio-pharma therapeutics – big pharma pipelines scarce Opportunistic market conditions Growing, worldwide renal patient population unaffected by economic cycles; predictable recurring revenues Critical need for iron therapeutics and renal products CMS bundling 2011 – should prove favorable to SFP and extension opportunities 22
37. EPO & Hemoglobin Generation It takes 25 days to create a red blood cell - Day 16: EPO receptors surround, protect, and incorporate into cell in order for it to mature - Day 19-20: more transferrin receptors exist around cell looking for iron to incorporate into cell It is crucial that iron be present between day 19-20 (not effective to add it later) important to maintain iron balance all the time - Day 21: If iron exists to incorporate into cell, it becomes a reticulocyte iron used to generate hemoglobin reticulocyte mature red blood cell (RBC) within 4 days 27