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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% …

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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  • 1. Innovative Bio-pharmaceutical
    Company
    July 2009
  • 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.
  • 3. Agenda
    3
  • 4. Corporate Overview
    4
  • 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
  • 7. Lead Drug Candidate
    SFP
    Soluble Ferric Pyrophosphate
    7
  • 8. SFP – Iron via Dialysate
    8
    Dialysis
    Dialyzer
    • Blood flows through Dialyzer membrane
    • 9. Dialysate flows outside of membrane in opposite direction
    • 10. Nutrients (Ca, K, Mg, Na) delivered into blood while toxins and waste are removed
    • 11. SFP (iron) now delivered into blood via dialysate just like nutrients
    • 12. Replaces kidney function
    • 13. Removes waste and excess fluids
    • 14. Replenishes nutrients
    • 15. 3-4 hour treatment
  • SFP – Iron via Dialysate
    • Bio-available iron delivered directly to blood stream
    • 16. Replaces iron in blood lost during each dialysis treatment
    • 17. Rapid uptake of iron by transferrin
    • 18. Transferrin takes iron to bone marrow
    • 19. Maintains iron balance within target hemoglobin range
    Inside Dialyzer Filter
    9
  • 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 $180 million
  • 21. Maximizes Erythropoiesis
    By maintaining constant iron balance SFP maximizes creation of red blood cells, generation of hemoglobin and optimization of EPO treatment response
    11
  • 22. SFP vs IV IronHemodialysis Dependent Chronic kidney Disease (HDD-CKD)
    12
    * high molecular weight sugar molecules have been linked to
    anaphylactic reactions; not present in SFP
  • 23. SFP Development Program
    13
  • 24. SFP Phase IIb Study
    Primary Endpoint: Drop in hemoglobin of 1 gm/dL or more and safety.
    Secondary Endpoints: Time taken to drop hemoglobin by 1 g/dL or more, increase in hemoglobin to more than 12.5 g/dL, reticulocyte hemoglobin, infection, iron transferred into the patient.
    Enrollment completed April 2009
    Two positive Data Safety Monitoring Board (DSMB) reviews to date; validates SFP superior safety profile
    Expect data Q4 2009 / Q1 2010
    14
  • 25. SFP Commercial Launch: 2012
    15
    Strategy: Leverage captive client relationships and
    distribution channels for fast SFP penetration
    * Forecast
  • 26. Intellectual Property
    Rockwell owns exclusive worldwide license
    Patents issued in U.S, Europe and Japan  three largest ESRD markets in the world
    Iron delivery via dialysate in hemodialysis (HD) and peritoneal dialysis (PD)
    Composition of matter and method of delivery
    Patent expires 2021 (including 5 year Hatch-Waxman)
    Patent filed on SFP-GMP grade formulation
    To cover dialysis, oral OTC/Rx, TPN, Oncology, and other extensions
    16
  • 27. Financial Overview
    17
  • 28. Key Financial Facts
    18
    *As of July 24, 2009
    **As of 1Q09
    **Excluding cash flow generation from core business
  • 29. Annual Sales Growth
    19
    ($, in Millions)
    2008
    Forecast*
    5-Year CAGR 23.6%
  • 30. Investment Opportunity
    & Upcoming Milestones
    20
  • 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
  • 33. Upcoming Milestones






    23
  • 34. Innovative Bio-pharmaceutical
    Company
    30142 Wixom Road
    Wixom, MI 48393 USA(248) 960-9009
    invest@rockwellmed.com
  • 35. Appendix
  • 36. FDA Clinical Studies
    26
  • 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