Rockwell Medical, Inc. · NASDAQ:RMTI
Rockwell Medical — Investor Presentation (May 2022)
30 slides from Rockwell Medical's investor presentation, May 20, 2022
Slide 1: Rockwell Medical Corporate Presentation May 2022
Rockwell Medical, Inc. Transforming Iron Deficiency Therapy (NASDAQ: RMTI) Corporate Presentation May 2022
Slide 2: Forward-Looking Statements
Forward - Looking Statements 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 develop FPC for new indications, and maintain concentrate sales . Words suc
Slide 3: Developing innovative therapies to transform the treatment of iron deficiency
Rockwell Medical, Inc. Developing innovative therapies to transform the treatment of iron deficiency 3 x Proprietary Drug • Next generation iron deficiency therapeutic • Applicable to many different patient populations • Two NDA approvals x Significant Opportunity: Home Infusio n Iron Therapy • Phas
Slide 4: Ferric Pyrophosphate Citrate (FPC): Next-generation intravenous iron therapy
Ferric Pyrophosphate Citrate (FPC) Next - generation intravenous iron therapy 4
Slide 5: Iron Deficiency: What problem needs to be solved?
Iron Deficiency: What problem needs to be solved? 5 Traditional IV iron products require an outpatient clinic visit , associated with rare severe reactions Oral iron is not adequate for many patients with moderate to severe IDA Iron Deficiency Can Result From… 1 Insufficient iron in diet Reduced GI
Slide 6: Iron Deficiency: What problem needs to be solved?
Iron Deficiency: What problem needs to be solved? 6 Traditional IV iron products require an outpatient clinic visit , associated with rare severe reactions Oral iron is not adequate for many patients with moderate to severe IDA Iron Deficiency Can Result From… 1 Insufficient iron in diet Reduced GI
Slide 7: FPC Uniquely Suited to Address Iron Deficiency
FPC Uniquely Suited to Address Iron Deficiency A true next generation IV iron with established efficacy and safety 7 1. Pratt R, et al. Biometals . 2018;31(6):1081 - 1089 2. Fishbane SN, et al. Ferric pyrophosphate citrate (Triferic Ρ ) administration via the dialysate maintains hemoglobin and iron
Slide 8: FPC for Iron Deficiency Anemia in Home Infusion
FPC for Iron Deficiency Anemia in Home Infusion New FPC product Novel presentation 505(b)(1) FDA approval Unique J - code Differentiated pricing 8
Slide 9: Healthcare is shifting to the home
Healthcare is shifting to the home Rapid growth post - pandemic is driven by lower cost of care and higher patient satisfaction 9 Healthcare at home is an attractive alternative. The shift is underway. Home infusion therapy is a critical component. Innovative medicine is needed. • Lower cost of care
Slide 10: Home infusion therapy is a high growth home care service
Home infusion therapy is a high growth home care service 10 2010: 829,000 2019: 3,224,427 Home Infusion Therapy Patients Served 1 Benefits include 2,3 … ↓ cost ↓ burden on healthcare resources ↑ quality of life ( QOL) ↓ rates of depression, fatigue ↓ opioid use ↓ risk of hospital/facility acquired i
Slide 11: The home infusion setting presents an opportunity for FPC
The home infusion setting presents an opportunity for FPC 11 Iron Deficiency Anemia is a common comorbidity. » Large and growing market » Previously established safety & efficacy » Potential to meaningfully improve lives Presents a significant opportunity for FPC. What is h ome infusion therapy? It
Slide 12: Home infusion patient populations are at risk of iron deficiency anemia
1. NHIA Infusion Industry Trends Report 2020. 2. Hwa YL, Rashtak S, Kelly DG, and Murray JA. Iron deficiency in long - term parenteral nutrition therapy. JPEN 2015. 3. Busti E, et al. Anemia and iron deficiency in cancer patients. Role of iron replacement therapy. Pharmaceuticals 2018, 11, 94. 4. Be
Slide 13: Treatment of iron deficiency anemia in home infusion patients is a broken process
Treatment of iron deficiency anemia in home infusion patients is a broken process. 13 A market research survey 1 assessed the current standard of care for management of IDA in home parenteral nutrition patients (HPN) , a subset of the home infusion population. Health care providers say… • Patients r
Slide 14: FPC may be uniquely suited to address IDA in home infusion patients
FPC may be uniquely suited to address the problem of IDA in home infusion patients. 14 Bioavailable iron even in the presence of inflammation and elevated hepcidin. Regular, low doses at home could treat and prevent recurrence of IDA. 3 1. Fishbane SN, Singh AK, Cournoyer SH, et al. Ferric pyrophosp
Slide 15: FPC for Home Infusion Clinical Development Plan
FPC for Home Infusion Clinical Development Plan Predictable efficacy and safety; low - risk development program 15 Phase II Observational Trial Phase III Trials PDUFA Commercial Launch Phase II Dose Scheduling Trial expected to start 2H 2022… ◊ FPC as a home infusion therapy (FPC - HI) vs. placebo f
Slide 16: Dialysis Market Opportunities
Dialysis Market Opportunities
Slide 17: We are an essential supplier in the hemodialysis market
We are an essential supplier in the hemodialysis market. LDO (DaVita) 175k Patients 36% 3 MDOs 58k Patients 10% 492,000 Estimated Total U.S. In - Center Hemodialysis Patients → Current target market is 27% or 132,000 patients LDO (Fresenius) 170,500 LDO (DaVita) 185,400 MDO's 50,200 SDO's / Indep. 8
Slide 18: Rockwell Dialysis Concentrates
18 Rockwell Dialysis Concentrates #2 >$60 million >15 million DaVitaBaxter Nipro We are an essential supplier in the hemodialysis market.
Slide 19: We are strengthening our dialysis concentrates business
We are strengthening our dialysis concentrates business 19 Rockwell Dialysis Concentrates » Updated key customer agreements • DaVita, Baxter, Nipro , other » Near - term expectations * … • Revenue growth from $60m to >$75m in 2022 • Cash burn reduction in 2022 by ~$11m (~$15m on an annualized basis)
Slide 20: Triferic and Triferic AVNU are FDA approved forms of FPC
Triferic® and Triferic AVNU Ρ are FDA approved forms of FPC Triferic has a strong value proposition for hemodialysis patients • Delivers 100% bioavailable iron, stabilizing Hb 1,2,3 • Conveniently delivered via dialysate or IV • Demonstrated to reduce overall cost of anemia drugs 4 Established safet
Slide 21: Pipeline Opportunity: FPC for Acute Heart Failure
Pipeline Opportunity: FPC for Acute Heart Failure Newly formulated FPC product Novel presentation 505(b)(1) FDA approval Unique J - code Differentiated pricing 21
Slide 22: New, Effective Treatments for Acute Heart Failure are Needed
New, Effective Treatments for Acute Heart Failure are Needed 1. Arrigo, M., Jessup, M., Mullens, W. et al. Acute heart failure. Nat Rev Dis Primers 6, 16 (2020). https://doi.org/10.1038/s41572 - 020 - 0151 - 7 . 2. Rizzo, C. Carbonara, R. Ruggieri, R. Iron Deficiency: A New Target for Patients With
Slide 23: A Significant Market Opportunity May Exist for FPC in Hospitalized AHF
A Significant Market Opportunity May Exist for FPC as a Treatment of Iron Deficiency in Hospitalized AHF 1. Enjuanes et al, Okonko et al, Cohen - Solal et al, Nunez et al, Van Aelst et al, multiple peer - reviewed publications on file (2011 - 2017) 2. Beale A, et al. Iron Deficiency in Acute Decompe
Slide 24: Upcoming Milestones
© ROCKWELL MEDICAL Upcoming Milestones
Slide 25: Projected Near-Term Milestones
Projected Near - Term Milestones 25 2022 ▪ IND approval / study start FPC for Home Infusion Phase II Study FPC for Acute Heart Failure (pipeline opportunity) ▪ Top - line data readout (treatment phase) ▪ Top - line data readout (maintenance phase) ▪ Updated customer agreements ▪ Positive gross margi
Slide 26: Advancing Our Portfolio With the Potential to Deliver Near Term Value
Rockwell Rockwell Rockwell TBD Jeil Pharma Jeil Pharma SUN Pharma Wanbang Biopharm (Fosun) Drogsan Pharma Advancing Our Portfolio With the Potential to Deliver Near Term Value FPC HI - 01, HI - 02: U.S. FPC HF:01: U.S. Preclinical Phase 1 Phase 2 Phase 3 Submitted Approved Commercial 26 FPC for Iron
Slide 27: Developing innovative therapies to transform the treatment of iron deficiency
Rockwell Medical, Inc. Developing innovative therapies to transform the treatment of iron deficiency 27 x Proprietary Drug • Next generation iron deficiency therapeutic • Applicable to many different patient populations • Two NDA approvals x Significant Opportunity: Home Infusio n Iron Therapy • Pha
Slide 28: Thank You
Thank You
Slide 29: Experienced Management Team
Experienced Management Team Proven track record and expertise in biopharma clinical development and commercialization 29 Management Team Marc Hoffman, M.D. Chief Medical Officer Years: 30+ Michael DeYoung VP Operations Years: 25 + Russell Ellison, M.D. Chief Executive Officer Years: 35+ Russell Skib
Slide 30: Balance Sheet Recap and Update
Balance Sheet Recap and Update • Cash and Cash Equivalents as of March 31, 2022 was $9.9 million. • Working capital as of March 31, 2022 was $5.2 million. • Cash and Cash Equivalents as of April 30, 2022 was $12.5 million. • Working capital as of April 30, 2022 was $10.3 million. 30