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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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Innovative Bio-pharmaceuticalCompany
July 2009
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Safe 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.
Agenda
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Corporate Overview
Lead Drug Candidate
Financial Overview
Investment Opportunity &
Upcoming Milestones
Corporate Overview
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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
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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
Lead Drug CandidateSFP
Soluble Ferric Pyrophosphate
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SFP – Iron via Dialysate
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Replaces kidney function Removes waste and excess fluids Replenishes nutrients 3-4 hour treatment
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
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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
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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
Maximizes Erythropoiesis
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By maintaining constant iron balance SFP maximizes creation of red blood cells, generation of hemoglobin and optimization of EPO treatment response
SFP vs IV IronHemodialysis Dependent Chronic kidney Disease (HDD-CKD)
SFP Venofer Ferrlecit Feraheme
Dose Size (iron) 10-15 μg/dL 100mg 125mg 500mg
Complexed with carbohydrate (sugar)backbone
No Yes Yes Yes
Molecular Weight(Da)*
< 1,000 34,000 – 60,000
289,000 –440,000
730,000
Est’d Iron Use (grams per year)
~1.5-50% less-
3 3 3
Iron Delivery Method
Slow Infusion during Dialysis
Injection/Infusion
Injection/Infusion
Injection
Approx. # of Admin./Yr
156 30 24 6
Rate of Iron Injection
2-3 mg/hr 20 mg/min 12.5mg/min > 510 mg/min
Nurse Time Per Dose
Not Applicable 2-5 min 5-10 min < 1 min
12* high molecular weight sugar molecules have been linked to anaphylactic reactions; not present in SFP
SFP Development Program
Past
•Pre-clinical safety, pharmacology & toxicity studies completed•Exception
al safety profile
•Phase IIa clinical trial completed •Proof of
concept study:12 mcg iron/dL dose
Present
•Phase IIb clinical trial – dose ranging•6 months/
25-30 sites/ 100-120 patients
•Data expected Q4 2009 / Q1 2010
•NIH funded clinical safety study•9 months/
multi sites/ 30 patients
•Data expected 2010
Future
•Q2 2010: Phase III initiation
•2011: Anticipated NDA/ANDA filing
•2011/2012: Estimated product launch
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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
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SFP Commercial Launch: 2012
2009
• 27% US dialysate share • $51.6M sales • 16.6M+ treatments
2012 Goals*
• 35% US dialysate share • $88M sales• 23M treatments• $200M captive US iron
market; $600M total• International partnerships
and royalty stream - additive
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Strategy: Leverage captive client relationships and distribution channels for fast SFP penetration
* Forecast
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
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Financial Overview
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Key Financial Facts
Shares Outstanding** 14.1M
Fully Diluted Shares Outstanding** 14.9M
Share Price (NASDAQ: RMTI)* $8.61
Market Cap* $122M
Revenues (ttm)** $52.1M
SFP Expected Annual Burn Rate*** $3.5-4M
Cash and Cash Equivalents** $3.35M
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*As of July 24, 2009**As of 1Q09**Excluding cash flow generation from core business
Annual Sales Growth
0102030405060
2004 2005 2006 2007 2008 2009 - Q1
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2008Forecast*
($, in Millions)
5-Year CAGR 23.6%
Investment Opportunity & Upcoming Milestones
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Investment Opportunity Bio-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
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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
Upcoming Milestones
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2008: Initial DSMB Phase IIb trial review 2008: Expand Scientific Advisory Board (+3 members)2008: Hire VP Drug Development & Medical AffairsQ2 2009: Second DSMB Phase IIb trial reviewQ2 2009: Complete enrollment for Phase IIbQ2 2009: Hire Chief Scientific Officer2009: Create Steering Committee Q4 2009: Complete Phase IIb trial Q4 2009 / Q1 2010: Release Phase IIb data Q2 2010: Initiate Phase III trial 2010: Release NIH data2011: File NDA/ANDA 2011 / 2012: Launch product
Innovative Bio-pharmaceuticalCompany
30142 Wixom RoadWixom, MI 48393 USA
(248) 960-9009
Appendix
FDA Clinical Studies
FDA Phase IIa FDA Phase IIb
StudyType
Dose Escalating Dose Ranging
Study Goals/Objectives
Determine optimal SFP iron dose
Determine maximum tolerated dose & minimum level benefits
Study Outcomes
Optimal Dose: 12mg/dl
700 human doses
Proven safe & effective. No adverse reactions
Dose range: 0, 5, 10, 12, 15, 20 mg/dl
10,000 human doses
Data expected Q4 2009
Study Duration
6 months 6 months
Number of Patients
24 100-120
Number of Sites
1 25-30
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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
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