Innovative Bio-pharmaceuticalCompany         July 2009
2Safe Harbor StatementThis 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.
Agenda3
Corporate Overview4
5Corporate SummaryBio-pharmaceutical drug company with established operating businessDevelopment of unique, proprietary renal drugsLead drug iron delivery via dialysate – new standard of care Expect superior patient outcomes vs. current therapiesWomen’s health, oncology and parenteral nutritionStrong, growing core operating renal businessBroad distribution channel and manufacturing base3 manufacturing plants; 27% U.S. market shareDialysate; removes toxins and replaces nutrients in blood Products needed to maintain human lifeProvided 16.6 million+ treatments in 2008
6Kidney Disease MarketChronic kidney disease (CKD) 19.2 million Progressive loss of renal function; 5-StagesEnd Stage Renal Disease (ESRD) – irreversible loss of kidney function  need dialysis to liveStage 5 = 395,000 US patients; 2 million worldwideStages 3 and 4 = 8.1 million US patientsSteady, growing market unaffected by economiesCausesDiabetes and obesity, CVD, hypertension, agingCurrent treatment optionsDialysis:  life-saving blood filtering treatmentKidney transplant
Lead Drug CandidateSFPSoluble Ferric Pyrophosphate7
SFP – Iron via Dialysate8   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 treatmentSFP – Iron via DialysateBio-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 rangeInside Dialyzer Filter9
10SFP AdvantagesPhysiological iron maintenance therapySlow infusion (10-15 µg/dL iron dose) via dialysate during scheduled dialysis session; 3X per week; works like dietary ironSmall dose replaces 5-7mg avg blood loss per sessionMaintains iron balance  efficiently matches EPO and hemoglobinSuperior safety benefits for patient + lowers provider costSafely travels direct to bloodstream  bypasses liver and avoids toxicity~2000 Clinical Doses to Date  No Adverse ReactionsSignificantly 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 potentialU.S. IV iron CKD $500 million ($430M+ ESRD)Global IV iron CKD $850 millionU.S. dialysis concentrates $180 million
Maximizes ErythropoiesisBy maintaining constant iron balance SFP maximizes creation of red blood cells, generation of hemoglobin and optimization of EPO treatment response11
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
SFP Development Program13
SFP Phase IIb StudyPrimary 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 2009Two positive Data Safety Monitoring Board (DSMB) reviews to date; validates SFP superior safety profileExpect data Q4 2009 / Q1 201014
SFP Commercial Launch: 2012 15Strategy: Leverage captive client relationships and  distribution channels for fast SFP penetration* Forecast
Intellectual PropertyRockwell owns exclusive worldwide licensePatents issued in U.S, Europe and Japan  three largest ESRD markets in the worldIron 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 formulationTo cover dialysis, oral OTC/Rx, TPN, Oncology, and other extensions16
Financial Overview17

RockWell Medical Technologies Update

  • 1.
  • 2.
    2Safe Harbor StatementThispresentation 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.
  • 4.
  • 5.
    5Corporate SummaryBio-pharmaceutical drugcompany with established operating businessDevelopment of unique, proprietary renal drugsLead drug iron delivery via dialysate – new standard of care Expect superior patient outcomes vs. current therapiesWomen’s health, oncology and parenteral nutritionStrong, growing core operating renal businessBroad distribution channel and manufacturing base3 manufacturing plants; 27% U.S. market shareDialysate; removes toxins and replaces nutrients in blood Products needed to maintain human lifeProvided 16.6 million+ treatments in 2008
  • 6.
    6Kidney Disease MarketChronickidney disease (CKD) 19.2 million Progressive loss of renal function; 5-StagesEnd Stage Renal Disease (ESRD) – irreversible loss of kidney function  need dialysis to liveStage 5 = 395,000 US patients; 2 million worldwideStages 3 and 4 = 8.1 million US patientsSteady, growing market unaffected by economiesCausesDiabetes and obesity, CVD, hypertension, agingCurrent treatment optionsDialysis: life-saving blood filtering treatmentKidney transplant
  • 7.
    Lead Drug CandidateSFPSolubleFerric Pyrophosphate7
  • 8.
    SFP – Ironvia Dialysate8 Dialysis Dialyzer Blood flows through Dialyzer membrane
  • 9.
    Dialysate flows outsideof membrane in opposite direction
  • 10.
    Nutrients (Ca, K,Mg, Na) delivered into blood while toxins and waste are removed
  • 11.
    SFP (iron) nowdelivered into blood via dialysate just like nutrients
  • 12.
  • 13.
    Removes waste andexcess fluids
  • 14.
  • 15.
    3-4 hour treatmentSFP– Iron via DialysateBio-available iron delivered directly to blood stream
  • 16.
    Replaces iron inblood lost during each dialysis treatment
  • 17.
    Rapid uptake ofiron by transferrin
  • 18.
  • 19.
    Maintains iron balancewithin target hemoglobin rangeInside Dialyzer Filter9
  • 20.
    10SFP AdvantagesPhysiological ironmaintenance therapySlow infusion (10-15 µg/dL iron dose) via dialysate during scheduled dialysis session; 3X per week; works like dietary ironSmall dose replaces 5-7mg avg blood loss per sessionMaintains iron balance  efficiently matches EPO and hemoglobinSuperior safety benefits for patient + lowers provider costSafely travels direct to bloodstream  bypasses liver and avoids toxicity~2000 Clinical Doses to Date  No Adverse ReactionsSignificantly 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 potentialU.S. IV iron CKD $500 million ($430M+ ESRD)Global IV iron CKD $850 millionU.S. dialysis concentrates $180 million
  • 21.
    Maximizes ErythropoiesisBy maintainingconstant iron balance SFP maximizes creation of red blood cells, generation of hemoglobin and optimization of EPO treatment response11
  • 22.
    SFP vs IVIronHemodialysis Dependent Chronic kidney Disease (HDD-CKD)12* high molecular weight sugar molecules have been linked to anaphylactic reactions; not present in SFP
  • 23.
  • 24.
    SFP Phase IIbStudyPrimary 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 2009Two positive Data Safety Monitoring Board (DSMB) reviews to date; validates SFP superior safety profileExpect data Q4 2009 / Q1 201014
  • 25.
    SFP Commercial Launch:2012 15Strategy: Leverage captive client relationships and distribution channels for fast SFP penetration* Forecast
  • 26.
    Intellectual PropertyRockwell ownsexclusive worldwide licensePatents issued in U.S, Europe and Japan  three largest ESRD markets in the worldIron 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 formulationTo cover dialysis, oral OTC/Rx, TPN, Oncology, and other extensions16
  • 27.