Rockwell Medical, Inc. · NASDAQ:RMTI
Rockwell Medical — Investor Presentation (January 2020)
21 slides from Rockwell Medical's investor presentation, Jan 15, 2020
Slide 1: Rockwell Medical
(©) ROCKWELL ‘i MEDICAL
Slide 2: Forward-looking statements
Certain statements in this presentation may constitute "forward - looking statements" within the meaning of the federal securities laws, including, but not limited to, Rockwell Medical’s intention to bring to market Triferic®, and I.V. Triferic® . W ords such as "may," "might," "will," "should," "be
Slide 3: Rockwell Medical Overview: Poised to Transform the Treatment of Anemia
Rockwell Medical Overview POISED TO TRANSFORM THE TREATMENT OF ANEMIA
Slide 4: Rockwell is repositioned for growth: Investment Highlights
Rockwell is repositioned for growth Investment Highlights Recently - formed executive team, Board of Directors and Medical Advisory Board: deep renal and pharma commercial experience 6 #2 supplier of dialysis concentrates in the U.S.; relationships with leading dialysis players ▪ Generates $60M+ rev
Slide 5: Triferic: A New Way to Treat Anemia
Triferic: A New Way to Treat Anemia THE ONLY IRON REPLACEMENT THERAPY INDICATED TO MAINTAIN HEMOGLOB IN
Slide 6: Multiple opportunities to drive long-term value of Triferic
Multiple opportunities to drive long - term value of Triferic Transforming Anemia Management 6 Dialysate Triferic I.V. Triferic Triferic Global ▪ U.S. Launch May 2019 ▪ Collecting real - world data from seven sites totaling 500+ patients; expect initial data readout in Q1 2020 ▪ Launched 3 - month E
Slide 7: Unmet Need in Iron Maintenance Therapy
Current treatment approaches overload the body with iron rather than providing true iron maintenance 7 Unmet Need in Iron Maintenance Therapy ▪ Blood loss and iron sequestration are leading causes of anemia in hemodialysis (HD) patients ▪ 5 - 7 mg iron loss during every HD treatment ▪ The current st
Slide 8: Triferic Replaces Iron Losses by Directly Donating Iron to Transferrin
Triferic Replaces Iron Losses by Directly Donating Iron to Transferrin for Red Blood Cell Production I.V. Iron Modified from Brittenham GM, Chapter 34. Disorders of Iron Homeostasis: Iron Deficiency and Iron Overload. In Hoffman R. and Furie B. eds. Hematology: Basic Principles and Practice. Saunder
Slide 9: Triferic Efficacy: Phase 3 Clinical Trials
1) Fishbane SN, Singh AK, Cournoyer SH, et al. Ferric pyrophosphate citrate (Triferic™) administration via the dialysate main tai ns hemoglobin and iron balance in chronic hemodialysis patients. Nephrol Dial Transplant. 2015;30(12):2019 - 2026. 9 Iron maintenance with Triferic provided bioavailable
Slide 10: Triferic ESA-Sparing PRIME Study and Pharmacoeconomic Benefits
Triferic® ESA - Sparing PRIME Study* NASDAQ: RMTI 10 Triferic Pharmacoeconomic Benefits * “Ferric pyrophosphate citrate administered via dialysate reduces erythropoiesis - stimulating agent use and maintains hemoglobin in hemodialysis patients.” Gupta et al. - Kidney International – 2015 Triferic ®
Slide 11: Triferic Commercial Opportunity and Strategy
Triferic Commercial Opportunity and Strategy BUILDING A LEADING COMMERCIAL AND MEDICAL ORGANIZATION TO TARGET A LARGE AND GROWING MARKET OPPORTUNITY
Slide 12: Large Global Market Opportunity
Hemodialysis Patients by Continent (1) 505k 934k 202k 70k 358k 11k ▪ 2+ million people receive hemodialysis annually (1) , worldwide ▪ 250+ million estimated annual hemodialysis treatments, with growth occurring due to increased rates of diabetes, obesity, and hypertension ▪ Once started on dialysis
Slide 13: Triferic U.S. Market Overview
$4+ billion spent on anemia management therapies annually in concentrated provider market NASDAQ: RMTI 13 Triferic ® U.S. Market Overview LDO Fresenius 179k Patients 37% LDO DaVita 175k Patients 36% SDO Independents 74k Patients 15% MDOs 58k Patients 12% In - Center Hemodialysis Patients Source: Nep
Slide 14: "Go to Market" Strategy: Building for Success
Other Indications / Disease States ‘ Dialysate Triferic will allow our commercial & medical team to establish future foundation for I.V. Triferic 14 “Go to Market” Strategy: Building for Success ▪ Establish a strong commercial, medical and clinical support team • Building team of approximately 25 co
Slide 15: Building a Leading Medical Platform
15 Building a Leading Medical Platform Efficacy Pharmaco - Economics Health Economic Outcomes Safety ▪ We believe Triferic’s unique mechanism of action will enable a wide range of benefits ▪ To successfully achieve our goal of becoming the standard of care, we are strengthening our medical capabilit
Slide 16: I.V. Triferic Overview
Expands U.S. access and more applicable to global markets heavily reliant on on - line bicarb generation NASDAQ: RMTI 16 I.V. Triferic Overview ▪ NDA submitted in May 2019 with PDUFA date of March 28, 2020 ▪ Hemodialysis market moving toward on - line bicarbonate generation in U.S.; already establis
Slide 17: Triferic International Updates
Estimated market potential >$1 billion in international markets NASDAQ: RMTI 17 Triferic International Updates China • Partnered to commercialize Triferic with Wanbang Biopharmaceutical • Clinical trial waiver denied by NMPA – assessing next steps with Wanbang • Low - to - mid 20% royalty due to Roc
Slide 18: Financial Highlights and Upcoming Milestones
Financial Highlights and Upcoming Milestones STABLE REVENUE FROM BASE BUSINESS WITH MULTIPLE UPCOMING CATALYS TS
Slide 19: Selected Financials
19 Selected Financials Metric ($ in millions) Q3 2019 (9 months / 09/30/19) FY 2018 (12 Months / 12/31/18) FY 2017 (12 Months / 12/31/17) Sales $45.8 $63.4 $57.3 Operating Loss $27.1 $32.4 $25.9 Cash Flow from Operations ($22.0) ($20.4) ($21.1) Cash & Investments: $29.0 $33.5 $33.1 Long - term Debt:
Slide 20: Key Upcoming Milestones
Multiple opportunities to create and sustain long - term value 20 Key Upcoming Milestones U.S. 2020 ▪ March 28, 2020 U.S. PDUFA date for I.V. Triferic ▪ Q1 2020: initial readout from real - world data initiatives at seven sites totaling 500+ patients ▪ Potential U.S. I.V. Triferic Launch Global 2020
Slide 21: Rockwell: Positioned for Growth
• Triferic is the FIRST and ONLY FDA - approved therapy indicated to replace iron and maintain hemoglobin levels in adult hemodialysis patients • Launched Dialysate Triferic and submitted NDA for I.V. Triferic • Building on long - established existing relationships with other leaders in dialysis: Ba
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