RockWell Medical Technologies Update

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    RockWell Medical Technologies Update - Presentation Transcript

    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
      • 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
    9. SFP – Iron via Dialysate
      • Bio-available iron delivered directly to blood stream
      • 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
      Inside Dialyzer Filter
      9
    10. 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 $180 million
    11. Maximizes Erythropoiesis
      By maintaining constant iron balance SFP maximizes creation of red blood cells, generation of hemoglobin and optimization of EPO treatment response
      11
    12. SFP vs IV IronHemodialysis Dependent Chronic kidney Disease (HDD-CKD)
      12
      * high molecular weight sugar molecules have been linked to
      anaphylactic reactions; not present in SFP
    13. SFP Development Program
      13
    14. SFP Phase IIb Study
      Primary Endpoint: Drop in hemoglobin of 1 gm/dL or more and safety.
      Secondary Endpoints: Time taken to drop hemoglobin by 1 g/dL or more, increase in hemoglobin to more than 12.5 g/dL, reticulocyte hemoglobin, infection, iron transferred into the patient.
      Enrollment completed April 2009
      Two positive Data Safety Monitoring Board (DSMB) reviews to date; validates SFP superior safety profile
      Expect data Q4 2009 / Q1 2010
      14
    15. SFP Commercial Launch: 2012
      15
      Strategy: Leverage captive client relationships and
      distribution channels for fast SFP penetration
      * Forecast
    16. Intellectual Property
      Rockwell owns exclusive worldwide license
      Patents issued in U.S, Europe and Japan  three largest ESRD markets in the world
      Iron delivery via dialysate in hemodialysis (HD) and peritoneal dialysis (PD)
      Composition of matter and method of delivery
      Patent expires 2021 (including 5 year Hatch-Waxman)
      Patent filed on SFP-GMP grade formulation
      To cover dialysis, oral OTC/Rx, TPN, Oncology, and other extensions
      16
    17. Financial Overview
      17
    18. Key Financial Facts
      18
      *As of July 24, 2009
      **As of 1Q09
      **Excluding cash flow generation from core business
    19. Annual Sales Growth
      19
      ($, in Millions)
      2008
      Forecast*
      5-Year CAGR 23.6%
    20. Investment Opportunity
      & Upcoming Milestones
      20
    21. 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
    22. 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
    23. Upcoming Milestones






      23
    24. Innovative Bio-pharmaceutical
      Company
      30142 Wixom Road
      Wixom, MI 48393 USA(248) 960-9009
      invest@rockwellmed.com
    25. Appendix
    26. FDA Clinical Studies
      26
    27. 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
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