Rockwell Medical, Inc. · NASDAQ:RMTI
Rockwell Medical — Investor Presentation (January 2019)
23 slides from Rockwell Medical's investor presentation, Jan 7, 2019
Slide 1: Forward Looking Language
Certain statements in this presentation may constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "could," "plan," "potential," "predict," "forecast," "proj
Slide 2: Investment Highlights
Fully integrated, public (Nasdaq: RMTI), biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD), with a focus on anemia management Newly-formed executive management team, Board of Directors and Scientific Advisory Board with deep renal and pharmaceutical
Slide 3: Experienced Management Team
Proven track record and expertise in renal sector NASDAQ: RMTI Experienced Management Team 4 Management Experience Years Stuart Paul CEO 25+ Angus Smith CFO 13 Ray Pratt, M.D. Chief Medical Officer 25+ Ajay Gupta, M.D. Chief Scientific Officer 25+ Mike DeYoung VP Operations 25+ Anne Boardman VP Stra
Slide 4: Triferic Commercialization Path
Multiple opportunities to drive long-term value of Triferic® NASDAQ: RMTI 6 Triferic® Commercialization Path Dialysate Triferic® U.S. Launch 1H 2019 Build sales & marketing organization and expand medical education initiatives Reimbursement within CMS bundle I.V. Triferic® File NDA 1H 2019 505 (b)(1
Slide 5: Competitive Landscape
Triferic® uniquely positioned to revolutionize renal anemia management NASDAQ: RMTI 7 Competitive Landscape Low Cost or Generic High Cost Convenience Labor Intensive Long-Acting ESA HIF-PH* Triferic® Short-Acting ESA AURYXIA I.V. Iron *Products are still in Phase III with Price and Efficacy TBD
Slide 6: Blood loss and iron sequestration are leading causes of anemia in hemodialysis patients
Blood loss and iron sequestration are leading causes of anemia in hemodialysis (HD) patients 5-7 mg iron loss during every HD treatment (3x/week, 156x/year) Iron losses are best replaced at every HD treatment, similar to concurrent replacement of Ca, Mg, K and bicarbonate losses by dialysis Current
Slide 7: Triferic Platform
Novel therapy that addresses the daily iron needs of dialysis patients and avoids iron toxicity NASDAQ: RMTI 9 Triferic® Platform FIRST and ONLY FDA-approved product indicated to maintain hemoglobin in hemodialysis-dependent CKD patients Replaces recurring iron loss during dialysis Maintains hemoglo
Slide 8: Triferic vs. Current I.V. Iron Therapy
NASDAQ: RMTI 10 Triferic® vs. Current I.V. Iron Therapy Triferic® works like dietary iron in the body to maintain hemoglobin Triferic® Indication: Replacement of Iron to Maintain Hemoglobin Key Benefits Donates iron immediately and completely to transferrin for transport to bone marrow Hemoglobin en
Slide 9: Triferic ESA-Sparing PRIME Study and Pharmacoeconomic Benefits
Triferic® ESA-Sparing PRIME Study* NASDAQ: RMTI 11 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® is in
Slide 10: Triferic Has a Proven Safety Record
Demonstrates consistent, well-defined safety profile suitable for long-term iron maintenance therapy NASDAQ: RMTI 12 Triferic® Has a Proven Safety Record Largest safety database submitted for registration of any parenteral iron product 1,440 patients received Triferic® every HD treatment for up to 1
Slide 11: I.V. Triferic: Eligible for TDAPA
Eligible for TDAPA; more applicable to global markets heavily reliant on on-line bicarb generation NASDAQ: RMTI 13 I.V. Triferic® Planned NDA filing in 1H 2019 with potential approval in 2020 Eligible for 24 months of TDAPA pricing, if approved by CMS Hemodialysis market moving toward on-line bicarb
Slide 12: Dialysate Triferic FDA-Approved & Ready to Launch in 2019
Dialysate Triferic® FDA-Approved & Ready to Launch in 2019 NASDAQ: RMTI 14 Potential to Transform Renal Anemia Management Triferic.com; accessed 12/3/2018 Triferic.com Gives Iron When and Where Patients Need it Triferic® enters the blood via dialysate and donates its iron immediately to transferrin,
Slide 13: U.S. Dialysis Market
Large market with recurring/predictable need: ESRD patients require lifetime dialysis 3x/week Key growth drivers: increased rates of diabetes, obesity, and hypertension Estimated 71 Million In-Center Hemodialysis Treatments Per Year NASDAQ: RMTI 15 U.S. Dialysis Market Source: U.S. Renal Data System
Slide 14: Triferic U.S. Market Overview
$4+ billion spent on anemia management therapies annually in concentrated provider market NASDAQ: RMTI 16 Triferic® U.S. Market Overview LDO Fresenius 179k Patients 39% LDO DaVita 175k Patients 38% SDO Independents 46k Patients 10% MDOs 58k Patients 13% In-Center Hemodialysis Patients Goal: 2019 lau
Slide 15: Key Drivers of Launch Success
Building the strategic framework to support Triferic® throughout its lifecycle NASDAQ: RMTI 17 Key Drivers of Launch Success INTERNAL Aligning organizational resources 1 Building an optimal commercial model 2 Establishing a leadership position in anemia through a patient- centric design 3 Securing o
Slide 16: U.S. Reimbursement Landscape
Vast majority of dialysis patients are covered by Medicare NASDAQ: RMTI 18 U.S. Reimbursement Landscape ~80% Patients ~20% Patients Medicare Coverage Commercial Insurance / Self Pay / Gov’t Programs / Medicaid Subject to CMS bundled pricing TDAPA (Transitional Drug Add-on Payment Adjustment) transit
Slide 17: TDAPA final rule pricing
TDAPA final rule NASDAQ: RMTI 19 Pricing – Dialysate & I.V. 2019 ESRD Final Rule Implications for Triferic® No transitional payment for Dialysate Triferic® Launch Dialysate Triferic® in 1H 19 Transitional payment applies only for new products approved on or after January 1, 2020 PDUFA date after Jan
Slide 18: Triferic R&D and Clinical Development Plan
Robust strategy driving long-term value NASDAQ: RMTI 20 Triferic® R&D and Clinical Development Plan Key Upcoming Clinical Trials Phase III I.V. Triferic® Study for Europe Reached agreement with EMA on development approach for I.V. Triferic® in Europe Single, Phase 3 trial required for Europe, suppor
Slide 19: Triferic International Priorities
Advance and establish partnerships in key value-driving territories around the globe NASDAQ: RMTI 21 Triferic® International Priorities Europe Identify partner for I.V. Triferic® Initiate Phase III program in collaboration with partner China Partnered to commercialize Triferic® with Wanbang Biopharm
Slide 20: Key Upcoming Milestones
Multiple opportunities to create and sustain long-term value NASDAQ: RMTI 22 Key Upcoming Milestones U.S. 2019 U.S. Dialysate Launch – 1H U.S. I.V. Triferic® NDA Filing – 1H Potential to expand and improve economics of concentrates business 2020 Potential I.V. Triferic® FDA Approval Potential U.S. I
Slide 21: Select Financials
NASDAQ: RMTI 23 Select Financials Metric FY 2018 YTD (Nine Months / 9/30/18) FY 2017 (12 Months / 12/31/17) Sales $46.5 million $57.3 million Operating Loss $23.0 million $25.9 million Cash Flow from Operations ($14.6) million ($21.1) million Cash & Investments*: $39.7 million $33.1 million Debt*: $
Slide 22: Why Rockwell? Why Now?
Repositioned for growth NASDAQ: RMTI 24 Why Rockwell? Why Now? Fully integrated, public (Nasdaq: RMTI), biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD), with a focus on anemia management Newly-formed executive management team, Board of Directors an
Slide 23: Why Rockwell? Why Now?
QROCKWELL Why Rockwell? Why Now? Repositioned for growth + Fully integrated, public (Nasdaq: RMTI), biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD), with a focus on anemia management + Newly-formed executive management team, Board of Directors and
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