Madrigal Pharmaceuticals, Inc. · NASDAQ:MDGL
Madrigal Pharmaceuticals — Corporate Update (March 2024)
31 slides from Madrigal Pharmaceuticals's corporate update, March 2024
Slide 1: Rezdiffra (resmetirom) FDA Approval Conference Call
Rezdiffra (resmetirom) FDA Approval Conference Call March 2024 NASDAQ: MDGL © 2024 Madrigal Pharmaceuticals. All rights reserved.
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation includes “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, that are based on Madrigal’s beliefs and assumptions and on information currently available to it, but are subject t
Slide 3: Agenda
Agenda Bill Sibold 1 Introduction Chief Executive Officer Madrigal Pharmaceuticals Disease Overview and Stephen Harrison, M.D. 2 Current Treatment Paradigm Medical Director, Pinnacle Clinical Research; Visiting Professor of Hepatology, Oxford; Lead Principal Investigator of the MAESTRO studies Becky
Slide 4: Terri's Story
Terri’s Story Terri is a patient leader in the NASH community Her story illustrates the serious burden of NASH progression ▪ She was told: “You have fatty liver, but don’t worry about it” ▪ NASH cirrhosis was later detected during gallbladder surgery ▪ Developed ascites, hepatic encephalopathy and t
Slide 5: Key Takeaways for Today's Call
Key Takeaways for Today’s Call Rezdiffra approval is First-in-class label Set to deliver an unprecedented positions Rezdiffra as successful launch and milestone foundational therapy maximize potential March 2024 Madrigal Pharmaceuticals 5
Slide 6: Strong Label Positions Rezdiffra as Foundational Therapy
Strong Label Positions Rezdiffra as Foundational Therapy Indicated for the treatment of NASH with moderate to advanced liver fibrosis (F2/F3) NOW APPROVED No biopsy requirement in label Once-daily, oral; simple dosing No contraindications; no boxed warning; no monitoring requirements beyond SOC Land
Slide 7: Disease Overview and Current Treatment Paradigm
Disease Overview and Current Treatment Paradigm
Slide 8: NASH is a Chronic and Progressive Liver Disease
NASH is a Chronic and Progressive Liver Disease NAFLD: Nonalcoholic Fatty Liver Disease: Entire spectrum of fatty liver disease in individuals without significant alcohol consumption NASH: NAFL: NASH Normal Liver Nonalcoholic Cirrhosis Nonalcoholic Fatty Liver with Fibrosis Steatohepatitis ▪ Isolate
Slide 9: The NASH Patient Journey, Diagnosis and Treatment
The NASH Patient Journey, Diagnosis and Treatment Initial Suspicion Diagnosis & Risk Assessment Treatment for Moderate to Advanced & Referral at Hep/GI (F2/F3) NASH Patients + Ongoing Diet, Exercise and Co-morbidity management Prior Approach: TODAY’S Approach: No treatments Initial Referral to Confi
Slide 10: Goal: Treat Before Negative Patient Outcomes Occur
Goal: Treat Before Negative Patient Outcomes Occur Up to 17X Higher Risk of Liver-Related Mortality in Patients with NASH with Moderate to Advanced Fibrosis1 17X ~22% higher risk of patients with F3 10X fibrosis progress to higher risk cirrhosis within 2 years2 1.41X 0 F0 F1 F2 F3 Goal: Treat NASH w
Slide 11: Review of Rezdiffra Label and Clinical Data
Review of Rezdiffra Label and Clinical Data
Slide 12: Rezdiffra Approval Supported by Comprehensive Clinical Development Program in NASH
Rezdiffra Approval Supported by One of the Most Comprehensive Clinical Development Programs in NASH MAESTRO-NAFLD-1 MAESTRO-NASH MAESTRO-NASH OUTCOMES Safety Moderate to Advanced Fibrosis Compensated Cirrhosis Evaluates safety and tolerability Evaluates NASH resolution and/or Event-driven trial eval
Slide 13: Phase 3 Data in New England Journal of Medicine Demonstrate Broad Response
Phase 3 Data in New England Journal of Medicine Demonstrate Broad Response 50% >70% >80% 50% of Rezdiffra-treated >70% of patients achieved > 80% of Rezdiffra-treated patients showed either a >30% reduction in patients achieved NASH resolution non-invasive test results fibrosis reversal or no or fib
Slide 14: Rezdiffra Indication: No Biopsy; Defined Patient Population
Rezdiffra Indication: No Biopsy; Defined Patient Population INDICATIONS AND USAGE1 NASH with moderate to advanced liver REZDIFFRA is a thyroid hormone receptor beta (THR-beta) agonist fibrosis (consistent with F2/F3) indicated in conjunction with diet and exercise for the treatment of adults with no
Slide 15: Rezdiffra Indication: Clearly States Where Rezdiffra Should Not Be Used
Rezdiffra Indication: Clearly States Where Rezdiffra Should Not Be Used INDICATIONS AND USAGE1 REZDIFFRA is a thyroid hormone receptor beta (THR-beta) agonist indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic nonalcoholic steatohepatitis (NASH) with modera
Slide 16: Rezdiffra Label: Simple Dosing Profile
Rezdiffra Label: Simple Dosing Profile DOSING AND ADMINISTRATION1 Simple, weight-based, no titration The recommended dosage of REZDIFFRA is based on actual body weight. For patients weighing: • <100 kg, the recommended dosage is 80 mg orally once daily. • ≥100 kg, the recommended dosage is 100 mg or
Slide 17: Rezdiffra Label: No Contraindications; Warnings and Precautions
Rezdiffra Label: No Contraindications; Warnings and Precautions Reinforce Standard of Care CONTRAINDICATIONS1 No contraindications; no boxed warning None. WARNINGS AND PRECAUTIONS1 Hepatoxicity; one patient from safety trial (did not have NASH); label reinforces • Hepatotoxicity: Monitor patients du
Slide 18: Rezdiffra Label: Strong Clinical Efficacy on Fibrosis Improvement and NASH Resolution
Rezdiffra Label: Strong Clinical Efficacy on Fibrosis Improvement and NASH Resolution Clinical Efficacy in Rezdiffra Label1 From Rezdiffra Label1 Placebo 80 mg 100 mg N=294 N=298 N=296 Improvement in liver fibrosis and • Two pathologists, Pathologist A and no worsening of steatohepatitis Pathologist
Slide 19: Consistent Efficacy Across All Endpoints, Doses, Patient Populations
Consistent Efficacy Across All Endpoints, Doses, Patient Populations Label F2/F3 Population1,2 Madrigal F1B/F2/F3 Population1,2 MAESTRO-NASH MAESTRO-NASH MAESTRO-NASH MAESTRO-NASH Prespecified Endpoints Label Endpoints Prespecified Endpoints Label Endpoints (NEJM) Placebo 80 mg 100 mg Placebo 80 mg
Slide 20: Rezdiffra Sets the Safety Bar in NASH
Rezdiffra Sets the Safety Bar in NASH Common Adverse Reactions Reported with Rezdiffra1,2 Rezdiffra 80 mg Rezdiffra 100 mg Placebo • Most frequent AEs were GI- Once Daily Once Daily Adverse Reaction related and generally transient N=294 N=298 N=296 with resolution over time n (EAIR1) n (EAIR1) n (EA
Slide 21: Rezdiffra Commercial Strategy
Rezdiffra Commercial Strategy
Slide 22: Specialty Launch Designed to Focus on 315,000 U.S. Patients
Specialty Launch Designed to Focus on 315,000 U.S. Patients U.S. NASH Waterfall at Launch1 Diagnosed NASH 1,500,000 population Diagnosed NASH with moderate 525,000 to advanced fibrosis (F2/F3) Diagnosed NASH with moderate to 315,000 advanced fibrosis (F2/F3) and seen by Launch Focus F2 F3 ~14K targe
Slide 23: Rezdiffra's Differentiated Position in the NASH Treatment Paradigm
Rezdiffra’s Differentiated Position in the NASH Treatment Paradigm Moderate to Advanced No or Mild Fibrosis Cirrhosis Fibrosis Fibrosis F4C F4D Stage F0 F1 F2 F3 Compensated Decompensated HCP Setting Primary Care + Specialists Specialists Hepatologist or Surgeon (Hep or GI) Primary Treatment Prevent
Slide 24: Our Stakeholders Are Ready and Waiting for a Therapy Like Rezdiffra
Our Stakeholders Are Ready and Waiting for a Therapy Like Rezdiffra Physicians Patients Payers In the treatment of NASH with When seeking a treatment for NASH Vast majority of payers moderate to advanced fibrosis: with moderate to advanced fibrosis: have a good understanding of disease state ~88% of
Slide 25: Establishing Pathway for Blockbuster, First-in-Disease Medicine
Establishing Pathway for Blockbuster, First-in-Disease Medicine Educate Physicians Create Treatment Pathway Ensure Access Prescription Key Processing (ME, PA) Reimbursement Goals Established Payer Affordability Fulfillment Engagement Coverage Commercial Decisions (P&T) coverage to ~80% by YE24 Time
Slide 26: Built a Winning Team Ready for Launch
Built a Winning Team Ready for Launch Commercial and Medical leadership team; each with 25+ years industry experience; numerous blockbuster launches Sales Medical Affairs ▪ 17 yrs. experience ▪ 8 yrs. in practice; ▪ Top performers 14 yrs. in industry ▪ Hep/GI experience ▪ M.D.s, Pharm.Ds., Ph.D.s HC
Slide 27: Pricing is Grounded in Benefit to Patients and Value to the Health System
Pricing is Grounded in Benefit to Patients and Value to the Health System Targeting a Costly Disease for the Health System Delivering a Cost-Effective Therapy Rezdiffra Price $76,000 $47,400 ~$120B Annual direct costs of NASH1 ICER cost-effectiveness Annual WAC price assessment $39,600 – $50,100 Pri
Slide 28: Madrigal Patient Support to Provide Access Support and Education
Madrigal Patient Support to Provide Access Support and Education Helping patients, no matter where they are Madrigal plans to focus on equitable access in the Rezdiffra treatment journey and affordability as the launch progresses: Educational resources • $10 co-pays for Commercial patients • Patient
Slide 29: Key Takeaways for Today's Call
Key Takeaways for Today’s Call Rezdiffra approval is First-in-class label Set to deliver an unprecedented positions Rezdiffra as successful launch and milestone foundational therapy maximize potential March 2024 Madrigal Pharmaceuticals 29
Slide 30: Q&A
Q&A GNadrigal
Slide 31: Rezdiffra (resmetirom) FDA Approval Conference Call
Rezdiffra (resmetirom) FDA Approval Conference Call March 2024 NASDAQ: MDGL © 2024 Madrigal Pharmaceuticals. All rights reserved.
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