Innovative Bio-pharmaceutical<br />Company<br />         July 2009<br />
2<br />Safe Harbor Statement<br />This presentation contains forward-looking statements.  All statements, other than state...
Agenda<br />3<br />
Corporate Overview<br />4<br />
5<br />Corporate Summary<br />Bio-pharmaceutical drug company with established operating business<br />Development of uniq...
6<br />Kidney Disease Market<br />Chronic kidney disease (CKD) 19.2 million <br />Progressive loss of renal function; 5-St...
Lead Drug Candidate<br />SFP<br />Soluble Ferric Pyrophosphate<br />7<br />
SFP – Iron via Dialysate<br />8<br />   Dialysis<br />  Dialyzer <br /><ul><li>Blood flows through Dialyzer membrane
Dialysate flows outside of membrane in opposite direction
Nutrients (Ca, K, Mg, Na) delivered into blood while toxins and waste are removed
SFP (iron) now delivered into blood via dialysate just like nutrients
Replaces kidney function
Removes waste and excess fluids
Replenishes nutrients
3-4 hour treatment</li></li></ul><li>SFP – Iron via Dialysate<br /><ul><li>Bio-available iron delivered directly to blood ...
Replaces iron in blood lost during each dialysis treatment
Rapid uptake of iron by transferrin
Transferrin takes iron to bone marrow
Maintains iron balance within  target hemoglobin range</li></ul>Inside Dialyzer Filter<br />9<br />
10<br />SFP Advantages<br />Physiological iron maintenance therapy<br />Slow infusion (10-15 µg/dL iron dose) via dialysat...
Maximizes Erythropoiesis<br />By maintaining constant iron balance SFP maximizes creation of red blood cells, generation o...
SFP vs IV IronHemodialysis Dependent Chronic kidney Disease (HDD-CKD)<br />12<br />* high molecular weight sugar molecules...
SFP Development Program<br />13<br />
SFP Phase IIb Study<br />Primary Endpoint: Drop in hemoglobin of 1 gm/dL or more and safety.<br />Secondary Endpoints: Tim...
SFP Commercial Launch: 2012 <br />15<br />Strategy: Leverage captive client relationships and  <br />distribution channels...
Intellectual Property<br />Rockwell owns exclusive worldwide license<br />Patents issued in U.S, Europe and Japan  three ...
Financial Overview<br />17<br />
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RockWell Medical Technologies Update

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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.

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RockWell Medical Technologies Update

  1. 1. Innovative Bio-pharmaceutical<br />Company<br /> July 2009<br />
  2. 2. 2<br />Safe Harbor Statement<br />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.<br />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.<br />
  3. 3. Agenda<br />3<br />
  4. 4. Corporate Overview<br />4<br />
  5. 5. 5<br />Corporate Summary<br />Bio-pharmaceutical drug company with established operating business<br />Development of unique, proprietary renal drugs<br />Lead drug iron delivery via dialysate – new standard of care <br />Expect superior patient outcomes vs. current therapies<br />Women’s health, oncology and parenteral nutrition<br />Strong, growing core operating renal business<br />Broad distribution channel and manufacturing base<br />3 manufacturing plants; 27% U.S. market share<br />Dialysate; removes toxins and replaces nutrients in blood <br />Products needed to maintain human life<br />Provided 16.6 million+ treatments in 2008<br />
  6. 6. 6<br />Kidney Disease Market<br />Chronic kidney disease (CKD) 19.2 million <br />Progressive loss of renal function; 5-Stages<br />End Stage Renal Disease (ESRD) – irreversible loss of kidney function  need dialysis to live<br />Stage 5 = 395,000 US patients; 2 million worldwide<br />Stages 3 and 4 = 8.1 million US patients<br />Steady, growing market unaffected by economies<br />Causes<br />Diabetes and obesity, CVD, hypertension, aging<br />Current treatment options<br />Dialysis: life-saving blood filtering treatment<br />Kidney transplant<br />
  7. 7. Lead Drug Candidate<br />SFP<br />Soluble Ferric Pyrophosphate<br />7<br />
  8. 8. SFP – Iron via Dialysate<br />8<br /> Dialysis<br /> Dialyzer <br /><ul><li>Blood flows through Dialyzer membrane
  9. 9. Dialysate flows outside of membrane in opposite direction
  10. 10. Nutrients (Ca, K, Mg, Na) delivered into blood while toxins and waste are removed
  11. 11. SFP (iron) now delivered into blood via dialysate just like nutrients
  12. 12. Replaces kidney function
  13. 13. Removes waste and excess fluids
  14. 14. Replenishes nutrients
  15. 15. 3-4 hour treatment</li></li></ul><li>SFP – Iron via Dialysate<br /><ul><li>Bio-available iron delivered directly to blood stream
  16. 16. Replaces iron in blood lost during each dialysis treatment
  17. 17. Rapid uptake of iron by transferrin
  18. 18. Transferrin takes iron to bone marrow
  19. 19. Maintains iron balance within target hemoglobin range</li></ul>Inside Dialyzer Filter<br />9<br />
  20. 20. 10<br />SFP Advantages<br />Physiological iron maintenance therapy<br />Slow infusion (10-15 µg/dL iron dose) via dialysate during scheduled dialysis session; 3X per week; works like dietary iron<br />Small dose replaces 5-7mg avg blood loss per session<br />Maintains iron balance  efficiently matches EPO and hemoglobin<br />Superior safety benefits for patient + lowers provider cost<br />Safely travels direct to bloodstream  bypasses liver and avoids toxicity<br />~2000 Clinical Doses to Date  No Adverse Reactions<br />Significantly lowers IV iron administration costs eliminates needles, syringes and RN time <br />Bundled reimbursement provides superior patient-outcome at lowest cost; significant EPO savings expected <br />Market potential<br />U.S. IV iron CKD $500 million ($430M+ ESRD)<br />Global IV iron CKD $850 million<br />U.S. dialysis concentrates $180 million<br />
  21. 21. Maximizes Erythropoiesis<br />By maintaining constant iron balance SFP maximizes creation of red blood cells, generation of hemoglobin and optimization of EPO treatment response<br />11<br />
  22. 22. SFP vs IV IronHemodialysis Dependent Chronic kidney Disease (HDD-CKD)<br />12<br />* high molecular weight sugar molecules have been linked to <br /> anaphylactic reactions; not present in SFP<br />
  23. 23. SFP Development Program<br />13<br />
  24. 24. SFP Phase IIb Study<br />Primary Endpoint: Drop in hemoglobin of 1 gm/dL or more and safety.<br />Secondary Endpoints: Time taken to drop hemoglobin by 1 g/dL or more, increase in hemoglobin to more than 12.5 g/dL, reticulocyte hemoglobin, infection, iron transferred into the patient.<br />Enrollment completed April 2009<br />Two positive Data Safety Monitoring Board (DSMB) reviews to date; validates SFP superior safety profile<br />Expect data Q4 2009 / Q1 2010<br />14<br />
  25. 25. SFP Commercial Launch: 2012 <br />15<br />Strategy: Leverage captive client relationships and <br />distribution channels for fast SFP penetration<br />* Forecast<br />
  26. 26. Intellectual Property<br />Rockwell owns exclusive worldwide license<br />Patents issued in U.S, Europe and Japan  three largest ESRD markets in the world<br />Iron delivery via dialysate in hemodialysis (HD) and peritoneal dialysis (PD)<br />Composition of matter and method of delivery <br />Patent expires 2021 (including 5 year Hatch-Waxman)<br />Patent filed on SFP-GMP grade formulation<br />To cover dialysis, oral OTC/Rx, TPN, Oncology, and other extensions<br />16<br />
  27. 27. Financial Overview<br />17<br />
  28. 28. Key Financial Facts<br />18<br />*As of July 24, 2009<br />**As of 1Q09<br />**Excluding cash flow generation from core business<br />
  29. 29. Annual Sales Growth <br />19<br />($, in Millions)<br />2008<br />Forecast*<br />5-Year CAGR 23.6%<br />
  30. 30. Investment Opportunity <br />& Upcoming Milestones<br />20<br />
  31. 31. Investment OpportunityBio-Pharma transition<br />Innovative, proprietary disruptive technology with lead-drug candidate SFP <br />Safer, more effective and substantial cost savings<br />Significant market potential $500M U.S. / $850M Global<br />Ready-made commercial distribution channel for fast market penetration of high-margin renal drugs<br />Solid customer base; $51.6M revenues in 2008 <br />Captive 35% market share to leverage ($88M) in 2011*<br />Regulatory development progressing <br />Ongoing Phase IIb FDA study / NIH funded study<br />Phase III study anticipated to begin enrollment Q2 2010<br />FDA approval and commercial launch anticipated 2011/2012<br />*Forecast<br />21<br />
  32. 32. Investment OpportunityBio-Pharma transition<br />Strong scientific clinical team; focus SFP success; leverage renal drug pipeline<br />Expanded SAB with 3 new anemia/iron deficiency experts<br />Hired VP of Drug Development and Medical Affairs<br />Hired Chief Scientific Officer<br />SFP formulation opportunity – leveraging into new markets <br />Secured other proprietary renal drugs<br />Favorable environment for bio-pharma therapeutics – big pharma pipelines scarce <br />Opportunistic market conditions<br />Growing, worldwide renal patient population unaffected by economic cycles; predictable recurring revenues<br />Critical need for iron therapeutics and renal products <br />CMS bundling 2011 – should prove favorable to SFP and extension opportunities<br />22<br />
  33. 33. Upcoming Milestones<br /><br /><br /><br /><br /><br /><br />23<br />
  34. 34. Innovative Bio-pharmaceutical<br />Company<br />30142 Wixom Road<br />Wixom, MI 48393 USA(248) 960-9009<br />invest@rockwellmed.com<br />
  35. 35. Appendix<br />
  36. 36. FDA Clinical Studies<br />26<br />
  37. 37. EPO & Hemoglobin Generation<br />It takes 25 days to create a red blood cell<br />- Day 16: EPO receptors surround, protect, and incorporate into cell in order for it to mature<br />- Day 19-20: more transferrin receptors exist around cell looking for iron to incorporate into cell<br /> It is crucial that iron be present between day 19-20 (not effective to add it later) <br /> important to maintain iron balance all the time <br />- 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<br />27<br />

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