Milestone Pharmaceuticals Inc. · NASDAQ:MIST
Milestone Pharmaceuticals — Investor Day (February 2025)
42 slides from Milestone Pharmaceuticals's investor day presentation, Feb 25, 2025
Slide 1: Commercial Investor Event: Preparation for Potential Launch of CARDAMYST
Commercial Investor Event: Preparation for Potential Launch of CARDAMYST (etripamil) Nasal Spray Joe Oliveto, President & CEO Lorenz Muller, CCO Investigational Product. Not approved for commercial use in any jurisdiction.
Slide 2: Disclaimer
Disclaimer This presentation discusses our intended promotional launch strategy for CARDAMYSTTM (etripamil) nasal spray, which has not yet been approved for commercial use in any jurisdiction. Our new drug application (“NDA”) remains under review by the U.S. Food and Drug Administration (“FDA”) with
Slide 3: Forward Looking Statements
Forward Looking Statements Commercial Investor Event: Preparation for Potential Launch of CARDAMYST │ February 25, 2025 3 The Presentation contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. Words s
Slide 4: Agenda
Agenda 4 Introduction and Overview The Problem Our Innovation The Opportunity Commercial Strategy and Execution 02 03 04 05 01 Commercial Investor Event: Preparation for Potential Launch of CARDAMYST │ February 25, 2025
Slide 5: Our Mission
Our Mission Commercial Investor Event: Preparation for Potential Launch of CARDAMYST │ February 25, 2025 5 We are a patient-centric biopharmaceutical company intending to bring etripamil nasal spray to patients living with paroxysmal supraventricular tachycardia (PSVT) and atrial fibrillation with r
Slide 6: 2025 – A Potentially Transformative Year for Milestone
2025 – A Potentially Transformative Year for Milestone *Feb 2025 – US Patent Office issued notice of allowance for patent covering repeat dose regimen Key: PDUFA = Prescription Drug User Fee Act / Commercial Investor Event: Preparation for Potential Launch of CARDAMYST │ February 25, 2025 6 • Potent
Slide 7: Our Vision for Commercial Success of CARDAMYST
Our Vision for Commercial Success of CARDAMYST Key: PSVT = Paroxysmal Supraventricular Tachycardia Commercial Investor Event: Preparation for Potential Launch of CARDAMYST │ February 25, 2025 7 Patients Empowerment Prescribers Provides a solution Payers Efficiency GOAL Easy to use Easy to prescribe
Slide 8: Agenda
Agenda 8 Introduction and Overview The Problem Our Innovation The Opportunity Commercial Strategy and Execution 02 03 04 05 01 Commercial Investor Event: Preparation for Potential Launch of CARDAMYST │ February 25, 2025
Slide 9: Agenda
Agenda 9 Introduction and Overview The Problem Our Innovation The Opportunity Commercial Strategy and Execution 02 03 04 05 01 Commercial Investor Event: Preparation for Potential Launch of CARDAMYST │ February 25, 2025
Slide 10: PSVT Puts a Significant Burden on Patients
PSVT Puts a Significant Burden on Patients Paroxysmal Supraventricular Tachycardia is a common symptomatic arrhythmia (abnormal heart rhythm) characterized by attacks of very rapid heart rate Commercial Investor Event: Preparation for Potential Launch of CARDAMYST │ February 25, 2025 10 Disease Char
Slide 11: Majority of Patients with PSVT have Anxiety and Reduced QoL
Majority of Patients with PSVT have Anxiety and Reduced QoL Both During and Between Episodes Key: ED = Emergency Department. Citations: ADD REFERENCES Commercial Investor Event: Preparation for Potential Launch of CARDAMYST │ February 25, 2025 11 >80% of all patients with PSVT report some level of a
Slide 12: Many Current Treatments are Inconvenient, Intrusive, and/or Ineffective
Many Current Treatments in the Market are Inconvenient, Intrusive, and/or Ineffective Key: BB = Beta Blocker; CCB = Calcium Channel Blocker Citations: Internal estimates based on market research and longitudinal analysis of Truven/Marketscan and Medicare claims data; Page RL et al. 2015 ACC/AHA/HRS
Slide 13: Underappreciated Journey of a Patient with PSVT
Underappreciated Journey of a Patient with PSVT: Drawn-out Diagnoses & Difficult, Limited Treatment Options Key: Rx = prescriptiont Commercial Investor Event: Preparation for Potential Launch of CARDAMYST │ February 25, 2025 13 Diagnosis Off-label Chronic Oral Rx Off-label “Pill in Pocket” Rx No Tre
Slide 14: PSVT Drives Significant Costs for the Healthcare System
PSVT Drives Significant Costs for the Healthcare System Citations: 1. Milestone Pharmaceuticals. Data on file. 2. Chew DS, et al. Am Heart J. 2021;233:132-140. 3. Murman DH, et al. Acad Emerg Med. 2007;14(6):578-581. 4. Sacks NC et al. Am J Cardiol. 2020 Jan 15;125(2):215-221. 5. Jiang S et al. J Ma
Slide 15: Agenda
Agenda 15 Introduction and Overview The Problem Our Innovation The Opportunity Commercial Strategy and Execution 02 03 04 05 01 Commercial Investor Event: Preparation for Potential Launch of CARDAMYST │ February 25, 2025
Slide 16: CARDAMYST is a Novel Investigational CCB Designed to Treat Episodes of PSVT
CARDAMYST is a Novel Investigational CCB Designed to Treat Episodes of PSVT Safely and Quickly NCE Short-acting CCB MOA very well understood and trusted Commercial Investor Event: Preparation for Potential Launch of CARDAMYST │ February 25, 2025 16 Fast onset of action, well tolerated Convenient pat
Slide 17: CARDAMYST Would Put Patients in Control of Their PSVT
CARDAMYST Would Put Patients in Control of Their PSVT Sources: Internal market research, Commercial Investor Event: Preparation for Potential Launch of CARDAMYST │ February 25, 2025 17 Efficacy Fast onset delivers quick relief from symptoms of PSVT Convenience On-demand use reduces reliance on healt
Slide 18: Fast Relief to More Patients: Efficacy Data from RAPID
Fast Relief to More Patients Efficacy Data from RAPID Commercial Investor Event: Preparation for Potential Launch of CARDAMYST │ February 25, 2025 18 Key: CI = confidence interval; HR = hazard ratio; SR = sinus rhythm 1. Stambler BS, et al. Lancet. 2023;402(10396):118-128. 0% 10% 20% 30% 40% 50% 60%
Slide 19: Well-Tolerated with a Favorable Safety Profile
Well-Tolerated with a Favorable Safety Profile Safety Data from RAPID 1. Randomized-period treatment-emergent adverse events, those ≥5% or those specifically tracked as potentially representing lowered blood pressure. 2. Safety Population. 3. Six of eight rated as mild, two of eight rated as moderat
Slide 20: Our Vision for Commercial Success of CARDAMYST
Our Vision for Commercial Success of CARDAMYST Key: HCP = Healthcare Provider Citations: Internal market research Commercial Investor Event: Preparation for Potential Launch of CARDAMYST │ February 25, 2025 20 Patients Empowerment Fast, reliable self-administration Less disruption, reliance on ED Le
Slide 21: Payers Recognize the Value of CARDAMYST
Payers Recognize the Value of CARDAMYST to Fill an Unmet Need for Cardiology HCPs Citations: Internal Market Research Commercial Investor Event: Preparation for Potential Launch of CARDAMYST │ February 25, 2025 21 Given rational pricing, not expected to be “budget-impacting” enough to warrant active
Slide 22: Agenda
Agenda 22 Introduction and Overview The Problem Our Innovation The Opportunity Commercial Strategy and Execution 02 03 04 05 01 Commercial Investor Event: Preparation for Potential Launch of CARDAMYST │ February 25, 2025
Slide 23: 2M+ Patients Cost the Healthcare System at Least $5 Billion Annually
2M+ Patients Cost the Healthcare System at Least $5 Billion Annually Key: PSVT = Paroxysmal Supraventricular Tachycardia Citations: 1. Rehorn M, et al. J Cardiovasc Electrophysiol. 2021 Aug;32(8):2199-2206. 2. IQVIA Pharmetrics Plus 2019 Commercial claims for patients <65yo and Medicare LDS 5% for p
Slide 24: Most Patients Could Use CARDAMYST Multiple Times per Year
3-5 times per year Most Patients with a Diagnosis of PSVT Over Time Could Use CARDAMYST Multiple Times per Year Citations:. 1. Stambler BS, et al. Lancet 2023 Jul 8;402(10396):118-128.; Stambler BS. et al. CIRCEP. 2022 Dec;15(12):e010915. 2. Ip JE et al. JACC. 2024 May 21;83(20):2032-2034.; Ip JE et
Slide 25: Patients with PSVT are Primarily Treated by Cardiologists
Patients with PSVT are Primarily Treated by Cardiologists in the Outpatient Setting Citations: Internal Market Research Commercial Investor Event: Preparation for Potential Launch of CARDAMYST │ February 25, 2025 25 Clinical Cardiologists Primary Care Physicians Electrophysiologists 10% 30% 60%
Slide 26: Versatility of CARDAMYST Leads to Multiple Use Cases
Versatility of CARDAMYST Leads to Multiple Use Cases Citations: Internal Market Research Commercial Investor Event: Preparation for Potential Launch of CARDAMYST │ February 25, 2025 26 Diagnosis Off-label Chronic Oral Rx Off-label “Pill in Pocket” Rx No Treatment Catheter Ablation ← Add ← Switch ← A
Slide 27: Cardiologists Expect to Prescribe CARDAMYST to Majority of Unablated Patients
Cardiologists Expect to Prescribe CARDAMYST to the Majority of Unablated Patients with PSVT Citation: Quantitative market research conducted by Triangle Insights Group (n=250 cardiologists), June-September 2020; Estimated number of unique patients with annual claims for PSVT from Truven MarketScan d
Slide 28: Electrophysiologists Have an Important Role to Play with CARDAMYST
Electrophysiologists Have an Important Role to Play with CARDAMYST Key: KOL = Key Opinion Leader; P&T = Pharmacy & Therapeutics; PSVT = Paroxysmal Supraventricular Tachycardia; AFib-RVR = Atrial Fibrillation with Rapid Ventricular Rate; EPs = Electrophysiologists Citations: Internal Market Research
Slide 29: Accessible and Compelling Commercial Opportunity for CARDAMYST
Accessible and Compelling Commercial Opportunity for CARDAMYST Key: MOA = Mechanism of Action; HRU = Healthcare Resource Utilization Citations: Internal Market Research and Longitudinal Analysis of Truven/Marketscan and Medicare claims data No anticipated branded competition Low barrier to prescribi
Slide 30: Agenda
Agenda 30 Introduction and Overview The Problem Our Innovation The Opportunity Commercial Strategy and Execution 02 03 04 05 01 Commercial Investor Event: Preparation for Potential Launch of CARDAMYST │ February 25, 2025
Slide 31: Fully Integrated and Experienced Launch Leadership Team
Fully Integrated and Experienced Launch Leadership Team Commercial Investor Event: Preparation for Potential Launch of CARDAMYST │ February 25, 2025 31 Lorenz Muller Chief Commercial Officer Jeff Moore VP of Sales Anita Holtz MSN, CRNP, CMD VP Head of Medical Affairs Roshan Girglani VP of Marketing
Slide 32: Go-to-Market Model for CARDAMYST
Go-to-Market Model for CARDAMYST Balancing Need to Generate Demand with Managing Commercial Burn Key: HCPs = Healthcare Providers Citations: Adopted from Sandberg Orne, L. et al; “Empowering the Next-Generation Launch Model”; Trinity White Paper, June 2022. Data on File (Symphony Open Claims, Veeva
Slide 33: Plans to Deliver Broad Quality Payer Coverage
Plans to Deliver Broad Quality Payer Coverage Commercial Investor Event: Preparation for Potential Launch of CARDAMYST │ February 25, 2025 33 Citations: Internal market research. Patients Accessible and Affordable Coverage with Low Need to Control Payers Not Onerous to Prescribe Healthcare Providers
Slide 34: Strong Value Proposition for CARDAMYST for Payers
Strong Value Proposition for CARDAMYST for Payers Can Lead to Broad Coverage without Onerous Restrictions for HCPs or Patients Key: U/M = Utilization Management; PA = Prior Authorization; I/E = Inclusion/ Exclusion; IDNs = Integrated Delivery Networks Citations: CRA Pricing Research 6/2022 Commercia
Slide 35: Key Elements of Launch Timeline for CARDAMYST
Key Elements of Launch Timeline for CARDAMYST Potential FDA approval expected March 27 Medical Information Center live Patient support services live Product available for order by pharmacies Market Access reimbursement support live Field Medical engaging with KOLs Sales reps generating demand mid-20
Slide 36: Priorities for Launching CARDAMYST
Priorities for Launching CARDAMYST Commercial Investor Event: Preparation for Potential Launch of CARDAMYST │ February 25, 2025 36 Awareness and Demand Generation Sales Leadership Sales Force Territories Sales Rep Hiring following potential approval Promotional Launch mid-2025 Access and HCP Experie
Slide 37: Factors Supporting Planned Launch Year Uptake of CARDAMYST
Factors Supporting Planned Launch Year Uptake of CARDAMYST Citations: Internal Market Research Commercial Investor Event: Preparation for Potential Launch of CARDAMYST │ February 25, 2025 37 • Initial sales force covers 50% of potential • Patients seeking treatment weekly • HCP familiarity and evide
Slide 38: Key Brand Performance Indicators for Planned Launch Year
Key Brand Performance Indicators for Planned Launch Year • New to Brand Prescriptions (NBRx) • Prescription Growth (week over week) *Acceptable coverage includes, for example, absence of step edits and reasonable prior authorizations / quantity limits Commercial Investor Event: Preparation for Poten
Slide 39: Anticipated Commercial Strategy
Anticipated Commercial Strategy Demonstrate Demand and Expand Key: NDA = New Drug Application; RWE = Real World Evidence FOUNDATION • NDA submission & review • Pubs & scientific presentations • KOL engagement • RWE generation and payer engagement • Commercial leadership in place POTENTIAL LAUNCH • F
Slide 40: Key Takeaways for Investment Thesis
Key Takeaways for Investment Thesis • Milestone offers near-term commercial and mid-term clinical development catalysts to investors • PSVT is a symptomatic and unpredictable condition without good patient-driven treatment options • PSVT affects 2M+ Americans and costs the healthcare system over $5B
Slide 41: Q&A
Commercial Investor Event: Preparation for Potential Launch of CARDAMYST │ February 25, 2025 41 Guy Rousseau, PhD SVP Regulatory Affairs & Quality Management Jeff Nelson Chief Operating Officer Amit Hasija Chief Financial Officer, EVP Corporate Development Q&A Lorenz Muller Chief Commercial Officer
Slide 42: Thank you
Thank you
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