Rockwell Medical, Inc. · NASDAQ:RMTI
Rockwell Medical — Investor Presentation (June 2020)
23 slides from Rockwell Medical's investor presentation, Jun 29, 2020
Slide 1: Rockwell Medical June/July 2020
©)ROCKWELL MEDICAL JUNE/JULY 2020
Slide 2: Forward Looking Language
Forward Looking Language Certain statements in this presentation may constitute "forward-looking statements" within the meaning of federal securities laws, including, but not limited to, Rockwell Medical’s intention to commercialize Triferic® Dialysate, and Triferic® AVNU. Words such as "may," "migh
Slide 3: Rockwell Medical Overview
Rockwell Medical Overview POISED TO TRANSFORM THE TREATMENT OF IRON DEFICIENCY AND ANEMIA
Slide 4: Investment Highlights
Investment Highlights Rockwell is repositioned for growth Commercial-stage company with platform technology designed to transform iron deficiency and anemia 1 in a variety of disease states across the globe – launched in ESRD, and Ph II ready for new indications Ferric pyrophosphate citrate (FPC, Tr
Slide 5: Experienced Management Team
Experienced Management Team Proven track record and commercial expertise in renal sector Management Team Russell Ellison, Mike DeYoung M.D. VP Operations Chief Executive Officer Years: 25+ Years: 35+ Ray Pratt, M.D. Chief Development Anne Boardman Officer VP Sales Years: 25+ Years: 25+ Marc Hoffman,
Slide 6: Triferic: A New Way to Treat Iron Deficiency and Anemia
Triferic: A New Way to Treat Iron Deficiency and Anemia 2 ND GENERATION PARENTERAL IRON: 100% IMMEDIATELY BIOAVAILABLE
Slide 7: Triferic Platform
Triferic Platform 2nd generation parenteral iron* : 100% immediately bioavailable iron and avoids iron toxicity ▪ Platform technology that can potentially be applied for treatment of iron deficiency and anemia in a number of disease states Triferic Replaces Iron Losses by Directly Donating Iron to T
Slide 8: Marketed in Renal, at Development Stage for New Indications
Marketed in Renal, at Development Stage for New Indications Triferic for renal indication… FPC for additional indications… Approved & Marketed Phase II Ready ▪ For iron replacement and ▪ For home infusion treatment of iron maintenance of hemoglobin in deficiency anemia in patients adult hemodialysis
Slide 9: Transforming Anemia Management in ESRD
Transforming Anemia Management in ESRD Multiple opportunities to drive long-term value of Triferic in dialysis Dialysate Triferic Triferic AVNU (I.V.) Triferic Global ▪ U.S. Launch May 2019 ▪ FDA approved March 27, 2020 ▪ Partnerships established in China, ▪ Collecting real-world data from multiple
Slide 10: Unmet Need in Iron Maintenance Therapy
Unmet Need in Iron Maintenance Therapy Treatment of iron deficiency anemia in dialysis patients presents challenges and risks Late Stage CKD Patients Initiate Hemodialysis ▪ Blood loss and iron sequestration are leading causes of anemia in and Are on Lifelong Treatment hemodialysis (HD) patients ▪ 5
Slide 11: Triferic Efficacy: Phase III Clinical Trials
Triferic Efficacy: Phase 3 Clinical Trials In controlled trials, Triferic maintained hemoglobin for 44 weeks without the need for supplemental IV iron and without increasing iron stores • CRUISE 1 & CRUISE 2 Clinical Trials1 ◦ 292 patients on Triferic ◦ 296 patients on Placebo ◦ Duration of 48 weeks
Slide 12: Triferic Pharmacoeconomic Benefits
Triferic Pharmacoeconomic Benefits Triferic ESA-Sparing PRIME Study* ▪ Significant ESA reduction vs. placebo in a double-blind PRIME Study: ESA Use and Hemoglobin Levels clinical study • 35% ESA reduction in Triferic® patients compared to placebo arm at 9 months • 74% ESA reduction in ESA-hyporespon
Slide 13: Real World Data: Single Site Observational
Real World Data: Single Site Observational Clinic utilizing Triferic saw IV iron by 74%, ESA Utilization by 23% and Hgb maintained 73.7% reduction in IV iron per patient/week 23.2% reduction in ESA equivalents per patient/week compared to baseline 13
Slide 14: Real World Data: Overall Clinical Impact
Real World Data: Overall Clinical Impact Additional data from USRDS on single clinic shows meaningful outcomes Rates for all cause and infection-related hospitalization, and mortality for HHD patients, 2016-17.* # of patient- Inpatient Infectious Deaths Year years (PY) at Hospitalizations days hospi
Slide 15: Triferic Commercial Opportunity and Strategy
Triferic Commercial Opportunity and Strategy INCREASING SALES IN A GROWING MARKET OPPORTUNITY: ANEMIA IN ESRD
Slide 16: Large Global Market Opportunity
Large Global Market Opportunity Global iron replacement market in dialysis presents an opportunity for Triferic ▪ 2+ million people receive hemodialysis annually(1), worldwide ▪ 250+ million estimated annual hemodialysis treatments, with growth occurring due to increased rates of diabetes, obesity,
Slide 17: Triferic International Updates
Triferic International Updates Significant progress advancing Triferic internationally China • Partnered to commercialize Triferic with Wanbang Biopharmaceutical • Clinical trial required for approval – protocol approved and trial initiation is pending • Low-to-mid 20% royalty due to Rockwell on Net
Slide 18: Triferic U.S. Market Overview
Triferic U.S. Market Overview U.S. is a concentrated provider market with LDOs servicing over 70% of patients. In-Center Hemodialysis Patients Estimated Total U.S. In-Center HD Treatments LDO 75 million LDO Fresenius 3 MDO’s SDO’s, DaVita Independents 179k Patients 58k 175k Patients 74k 37% Patients
Slide 19: Triferic AVNU (I.V.) Overview
Triferic AVNU (I.V.) Overview Expands U.S. access and more applicable to global markets heavily reliant on on-line bicarb generation • Triferic AVNU received FDA Approval on March 27, 2020 – Triferic AVNU joins Triferic Dialysate as the only FDA-approved products indicated to replace iron and mainta
Slide 20: Financial Highlights and Upcoming Milestones
Financial Highlights and Upcoming Milestones STABLE REVENUE FROM BASE BUSINESS WITH MULTIPLE UPCOMING CATALYS TS
Slide 21: Selected Financials
Selected Financials $60+ million $48.9 million 69 million Cash, Cash Equivalents & Common Shares Outstanding at Annualized Net Sales Investments at 3/31/20 3/31/20 21
Slide 22: New Indication Opportunities for FPC
New Indication Opportunities for FPC • Evaluated multiple potential new indication opportunities for FPC and treatment of iron deficiency and/or anemia • FPC as an iron therapeutic has the potential to provide benefit in multiple disease states • Based on analysis of development considerations, econ
Slide 23: Rockwell: Positioned for Growth
Rockwell: Positioned for Growth • Triferic is a novel iron replacement therapeutic – delivers 100% immediately bioavailable iron with a safety profile similar to placebo • Launched Dialysate Triferic and gained FDA approval for Triferic AVNU • Building on long-established existing relationships with