EX-99.2 3 d788116dex992.htm EX-99.2 EX-99.2

Exhibit 99.2

 

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Rezdiffr (resmetirom) FDA Approval Conference Call March 2024 NASDAQ: MDGL © 2024 Madrigal Pharmaceuticals. All rights reserved.


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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 to factors beyond its control. Forward-looking statements reflect management’s current knowledge, assumptions, judgment and expectations regarding future performance or events. Forward-looking statements include all statements that are not historical facts; statements referenced by forward-looking statement identifiers; and statements regarding: Rezdiffra (resmetirom) and its expected use for treating NASH with moderate to advanced fibrosis; the initiation of the commercial launch of Rezdiffra including statements regarding commercial insurance and the anticipated time to fill prescriptions; estimates of patients diagnosed with NASH and market opportunities; the relationship between NASH progression and adverse patient outcomes; the estimated clinical burden of uncontrolled NASH; analyses for patients with NASH with moderate to advanced fibrosis concerning potential progression to cirrhosis, decompensated cirrhosis, liver transplant or death; cardiovascular risks, comorbidities and outcomes; health economics assessments or projections; indicating Rezdiffra has been shown to improve the fibrosis that is associated with progression to cirrhosis and its complications and resolve the underlying inflammation that drives the disease; projections or objectives for obtaining full approval for Rezdiffra (resmetirom), including those concerning potential clinical benefit to support potential full approval; regarding post-approval requirements and commitments; reduced risk of progression to cirrhosis, liver failure, need for liver transplant and premature mortality; treatment paradigm; improved liver enzymes, fibrosis biomarkers and imaging tests; the potential efficacy and safety of Rezdiffra (resmetirom) for noncirrhotic NASH patients and cirrhotic NASH patients; possible or assumed future results of operations and expenses, business strategies and plans (including ex-US. Launch/partnering plans); research and development activities, the timing and results associated with the future development of Rezdiffra (resmetirom), the timing and completion of projected future clinical milestone events, including enrollment, additional studies, the potential to support an additional indication for Rezdiffra (resmetirom) in patients with well-compensated NASH cirrhosis; optimal dosing levels for Rezdiffra (resmetirom); potential NASH or NAFLD and potential patient benefits with Rezdiffra (resmetirom), including future NASH resolution, safety, fibrosis treatment, cardiovascular effects, lipid treatment, and/or biomarker effects with Rezdiffra (resmetirom); and strategies, objectives and commercial opportunities, including potential prospects or results. Forward-looking statements can be identified by terms such as “accelerate,” “achieve,” “allow,” “anticipates,” “appear,” “be,” “believes,” “can,” “confidence,” “continue,” “could,” “demonstrates,” ”design,” “estimates,” “expectation,” “expects,” “forecasts,” “future,” “goal,” “help,” “hopeful,” “inform,” inform,” “intended,” “intends,” “may,” “might,” “on track,” “planned,” “planning,” “plans,” “positions,” “potential,” “powers,” “predicts,” ”predictive,” “projects,” “seeks,” “should,” “will,” “will achieve,” “will be,” “would” or similar expressions and the negatives of those terms. Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to: the assumptions underlying the forward-looking statements; risks of obtaining and maintaining regulatory approvals, including, but not limited to, potential regulatory delays or rejections; the challenges with the commercial launch of a new product, particularly for a company that does not have commercial experience; risks associated with meeting the objectives of Madrigal’s clinical studies, including, but not limited to Madrigal’s ability to achieve enrollment objectives concerning patient numbers (including an adequate safety database), outcomes objectives and/or timing objectives for Madrigal’s studies; any delays or failures in enrollment, and the occurrence of adverse safety events; risks related to the effects of Rezdiffra’s (resmetirom’s) mechanism of action; enrollment and trial conclusion uncertainties; market demand for and acceptance of our product; the potential inability to raise sufficient capital to fund ongoing operations as currently planned or to obtain financings on terms similar to those arranged in the past; the ability to service indebtedness and otherwise comply with debt covenants; outcomes or trends from competitive studies; future topline data timing or results; our ability to prevent and/or mitigate cyber attacks; the timing and outcomes of clinical studies of Rezdiffra (resmetirom); the uncertainties inherent in clinical testing; and uncertainties concerning analyses or assessments outside of a controlled clinical trial. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Madrigal undertakes no obligation to update any forward-looking statements to reflect new information, events, or circumstances after the date they are made, or to reflect the occurrence of unanticipated events. Please refer to Madrigal’s submissions filed with the U.S. Securities and Exchange Commission, or SEC, for more detailed information regarding these risks and uncertainties and other factors that may cause actual results to differ materially from those expressed or implied. Madrigal specifically discusses these risks and uncertainties in greater detail in the sections appearing in Part I, Item 1A of its Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on February 28, 2024, and as updated from time to time by Madrigal’s other filings with the SEC. March 2024 Madrigal Pharmaceuticals 2


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Agenda Bill Sibold 1 Introduction Chief Executive Officer Madrigal Pharmaceuticals Disease Overview and Stephen Harrison, M.D. 2 Medical Director, Pinnacle Clinical Research; Visiting Professor of Current Treatment Paradigm Hepatology, Oxford; Lead Principal Investigator of the MAESTRO studies Becky Taub, M.D. 3 Review of Rezdiffra Label and Clinical Data Chief Medical Officer and President of R&D Madrigal Pharmaceuticals 4 Rezdiffra Commercial Strategy Bill Sibold Bill Sibold, Stephen Harrison, Becky Taub and 5 Q&A Mardi Dier Chief Financial Officer Madrigal Pharmaceuticals


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Terri’s Story Terri is a patient leader in the NASH community Her story illustrates the serious burden of NASH progression â–ª She was told: “You have fatty liver, but don’t worry about it” â–ª NASH cirrhosis was later detected during gallbladder surgery â–ª Developed ascites, hepatic encephalopathy and then hepatocellular carcinoma â–ª Ultimately had liver transplant, but difficult post-transplant experience NASH, nonalcoholic steatohepatitis. Ascites, excess abdominal fluid and swelling. Hepatic encephalopathy, impaired cognitive function due to the liver’s inability to filter toxins from the blood. Hepatocellular carcinoma, liver cancer.


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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


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Strong Label Positions Rezdiffra as Foundational Therapy NOW APPROVED Indicated for the treatment of NASH with moderate to advanced liver fibrosis (F2/F3) No biopsy requirement in label Once-daily, oral; simple dosing No contraindications; no boxed warning; no monitoring requirements beyond SOC Landmark label for first FDA-approved medicine for NASH sets standard for potential future treatments Source: Rezdiffra prescribing information. West Conshohocken, PA: Madrigal Pharmaceuticals, Inc.; 2024. SOC, standard of care March 2024 Madrigal Pharmaceuticals 6


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Disease Overview and Current Treatment Paradigm


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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 â–ª Isolated steatosis â–ª Steatosis â–ª F1: fibrosis stage 1 = â–ª F4: fibrosis stage 4 = Fat accumulation (fat in ≥5% of â–ª Ballooning Mild Cirrhosis hepatocytes) â–ª Inflammation Moderate to Advanced â–ª F2: fibrosis stage 2 â–ª F3: fibrosis stage 3 NASH is the more advanced form of NAFLD, which can progress to cirrhosis, liver failure, or result in premature death1-5 Hepatocytes, liver cells. Steatosis, excess fat in liver cells. Steatohepatitis, build up of excess fat in liver cells causing inflammation and damage. 1. Sheka AC, et al. JAMA. 2020;323(12):1175-83. 2. Alkhouri N, McCullough AJ. Gastroenterol Hepatol (N Y). 2012;8(10):661-8. 3. EASL–EASD–EASO. J Hepatol. 2016;64:1388-402. 4. Diehl AM, Day C. NEJM. 2017;377:3063-72. 5. Honda et al. Int J Mol Sci. 2020;21:4039. March 2024 Madrigal Pharmaceuticals 8


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The NASH Patient Journey, Diagnosis and Treatment Madrigal Pharmaceuticals 9 Hep, hepatologist; GI, gastroenterologist; NITs, noninvasive tests. Initial Suspicion & Referral Diagnosis & Risk Assessment at Hep/GI Treatment for Moderate to Advanced (F2/F3) NASH Patients Initial suspicion at primary care Referral to a specialist (Hep/GI) + Ongoing Diet, Exercise and Co-morbidity management Prior Approach: No treatments available to halt or improve fibrosis; resolve NASH TODAY’S Approach: Confirmation of NASH diagnosis and fibrosis using NITs March 2024


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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 cirrhosis within 2 years2 risk 1.41X 0 F0 F1 F2 F3 Goal: Treat NASH with moderate to advanced fibrosis before negative patient outcomes occur 1. Angulo P, et al. Gastroenterology. 2015;149:389-397. 2. Loomba R, Adams L. Hepatology. 2019;70(6):1885-1888.


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Review of Rezdiffra Label and Clinical Data


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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 evaluating as measured by incidence of fibrosis improvement on liver biopsy progression to hepatic adverse events and composite clinical events decompensation 52 weeks (completed) 52 weeks biopsy (completed) ~36 months 54 months clinical outcomes ~1,200 patients, including 200 ~1,750 patients (ongoing) ~700 patients (recruiting) with compensated cirrhosis


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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 fibrosis improvement1 (MRI-PDFF)2 fibrosis progression3 MRI-PDFF, magnetic resonance imaging-proton density fat fraction. Source: Harrison S, et al. N Engl J Med. 2024 Feb;390(6):497-509. 1. 50% of patients on 100mg with eligible biopsies at 52 weeks achieved NASH resolution or fibrosis improvement. NEJM supplement Table S9. 2. >70% of patients on 100mg achieved >30% reduction in MRI-PDFF at 52 weeks. NEJM supplement Table S10. 3. >80% of Rezdiffra-treated patients (F1B or F2 at baseline) achieved fibrosis reversal or no fibrosis progression at 52 weeks. NEJM supplement Figure S5.


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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 noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). No biopsy requirement This indication is approved under accelerated approval based on improvement of NASH and fibrosis. Continued approval for this indication No contraindications; no boxed warning; may be contingent upon verification and description of clinical benefit in no monitoring requirements beyond SOC confirmatory trials. 1. Rezdiffra prescribing information. West Conshohocken, PA: Madrigal Pharmaceuticals, Inc.; 2024. SOC, standard of care.


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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 moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). This indication is approved under accelerated approval based on improvement of NASH and fibrosis. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Limitations of Use Avoid use of Rezdiffra in patients with Avoid use of REZDIFFRA in patients with decompensated cirrhosis decompensated cirrhosis 1. Rezdiffra prescribing information. West Conshohocken, PA: Madrigal Pharmaceuticals, Inc.; 2024.


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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 orally once daily. Oral, once-daily Administer REZDIFFRA with or without food. DOSING FORMS AND STRENGTHS1 Tablets: 60 mg, 80 mg, or 100 mg 3 strengths: 60 mg, 80 mg, 100 mg 1. Rezdiffra prescribing information. West Conshohocken, PA: Madrigal Pharmaceuticals, Inc.; 2024.


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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 during treatment with REZDIFFRA standard of care for elevations in liver tests and for the development of liver-related adverse reactions. Discontinue REZDIFFRA and continue to monitor the patient if hepatotoxicity is suspected. Gallbladder-related AEs; higher incidence • Gallbladder-Related Adverse Reactions: Cholelithiasis and in NASH patients; overall incidence low cholecystitis were observed more often in REZDIFFRA-treated with Rezdiffra (<1%) patients. If cholelithiasis is suspected, gallbladder diagnostic studies and appropriate clinical follow-up are indicated. If an acute gallbladder event such as acute cholecystitis is suspected, interrupt REZDIFFRA treatment until the event is resolved. 1. Rezdiffra prescribing information. West Conshohocken, PA: Madrigal Pharmaceuticals, Inc.; 2024.


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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 B, independently read the liver Response rate, biopsies for each patient. 15 23 28 Pathologist A (%) Difference in response 8 (2, 14) 13 (7, 20) rate vs. placebo (95% CI) o Both the 80 mg once daily and the 100 Response rate, mg once daily dosages of REZDIFFRA 13 23 24 Pathologist B (%) demonstrated improvement on these Difference in response 11 (5, 17) 11 (5, 7) rate vs. placebo (95% CI) histopathology endpoints at Month 12 Resolution of steatohepatitis and compared to placebo. no worsening of liver fibrosis Response rate, 13 27 36 • In a statistical analysis incorporating both Pathologist A (%) Difference in response pathologists’ independent readings, REZDIFFRA 14 (8, 20) 23 (16, 30) rate vs. placebo (95% CI) achieved statistical significance on both Response rate, 9 26 24 histopathology endpoints for both doses. Pathologist B (%) Difference in response 17 (11, 23) 15 (9, 21) rate vs. placebo (95% CI) 1. Rezdiffra prescribing information. West Conshohocken, PA: Madrigal Pharmaceuticals, Inc.; 2024. Label: The 888 population was based on patients determined to be F2/F3 based on scoring of the baseline liver biopsy by a central reviewer at the time of randomization into the study. FDA Endpoints: Liver fibrosis was evaluated on the NASH Clinical Research Network (CRN) fibrosis score as 0 to 4. Resolution of steatohepatitis was defined as a score of 0–1 for inflammation, 0 for ballooning, and any value for steatosis. No worsening of steatohepatitis was defined as no increase in score for ballooning, inflammation, or steatosis. Estimated using the Mantel-Haenszel method stratified by baseline type 2 diabetes status (presence or absence) and fibrosis stage (F2 or F3). 95% stratified Newcombe confidence intervals (CIs) are provided. Patients with missing liver biopsy at Month 12 are considered a non-responder.


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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 100 mg Placebo 80 mg 100 mg Placebo 80 mg 100 mg Fibrosis 14% 23% 26% 16% 25% 27% 12% 23% 24% 14% 24% 26% Improvement p < 0.001 p < 0.001 p = 0.002 p < 0.001 p < 0.001 p < 0.001 p < 0.001 p < 0.001 NASH 11% 25% 30% 9% 24% 29% 12% 27% 32% 10% 26% 30% Resolution p < 0.001 p < 0.001 p < 0.001 p < 0.001 p < 0.001 p < 0.001 p < 0.001 p < 0.001 Number of 888 888 966 966 Patients 1. Label: The 888 population was based on patients determined to be F2/F3 based on scoring of the baseline liver biopsy by a central reviewer at the time of randomization into the study. Label Endpoints: Liver fibrosis was evaluated on the NASH Clinical Research Network (CRN) fibrosis score as 0 to 4. Resolution of steatohepatitis was defined as a score of 0–1 for inflammation, 0 for ballooning, and any value for steatosis. No worsening of steatohepatitis was defined as no increase in score for ballooning, inflammation, or steatosis. Estimated using the Mantel-Haenszel method stratified by baseline type 2 diabetes status (presence or absence) and fibrosis stage (F2 or F3). 95% stratified Newcombe confidence intervals (CIs) are provided. Patients with missing liver biopsy at Month 12 are considered a non-responder. 2. MADRIGAL: 966 population of F1B, F2, F3 patients was based on the primary efficacy read of baseline slides that was conducted by Path A and Path B near the Week 52 completion date. Madrigal Endpoints: Resolution of NASH Resolution of steatohepatitis was defined as a score of 0–1 for inflammation, 0 for ballooning, and any value for steatosis with no worsening of fibrosis stage and at least a 2-point reduction in NAS. Fibrosis improvement, at least a 1 stage improvement in fibrosis with no worsening of NAS. NAS, NAFLD Activity Score, the unweighted sum of the scores for steatosis (0-3), lobular inflammation (0-3), and ballooning (0-2); thus ranging from 0 to 8.


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Rezdiffra Sets the Safety Bar in NASH Common Adverse Reactions Reported with Rezdiffra1,2 Rezdiffra 80 mg Rezdiffra 100 mg Placebo • Once Daily Once Daily Most frequent AEs were GI- Adverse Reaction N=294 N=298 N=296 related and generally transient with resolution over time n (EAIR1) n (EAIR1) n (EAIR1) Diarrhea 52 (14) 78 (23) 98 (33) • Diarrhea lasted on average 2-3 Nausea 36 (9) 65 (18) 51 (15) weeks often characterized as loose stools or worsening of Pruritus 18(4) 24(6) 36 (10) underlying diarrhea Vomiting 15 (4) 27 (7) 30 (8) Constipation 18 (4) 20 (5) 28 (8) Abdominal pain 18 (4) 22 (5) 27 (7) Dizziness 6 (1) 17 (4) 17 (4) Pruritus, itchiness of skin; AEs, adverse events; EAIR, exposure-adjusted incidence rate; PY, person-years. 1. The EAIR per 100 PY can be interpreted as an estimated number of first occurrences of the adverse reaction of interest if 100 patients are treated for one year. 2. Rezdiffra prescribing information. West Conshohocken, PA: Madrigal Pharmaceuticals, Inc.; 2024.


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Rezdiffra Commercial Strategy


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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) 315,000 Diagnosed NASH with moderate to Launch Focus advanced fibrosis (F2/F3) and seen by F2 F3 ~14K target specialists 190K 125K 1. Forian Claims Data; Clearview Analysis; Fishman J, et al. Poster presented at: ISPOR 2023; May 7-10, 2023; Boston, MA. Data on file: REF-00571. March 2024 Madrigal Pharmaceuticals 22


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Rezdiffra’s Differentiated Position in the NASH Treatment Paradigm March 2024 Madrigal Pharmaceuticals 23 No or Mild Fibrosis Moderate to Advanced Fibrosis Cirrhosis Fibrosis Stage HCP Setting Primary Treatment Goal Potential Treatment Lifestyle change, GLP-1 OUTCOMES trial in F4C Liver Transplant F0 F1 F2 F3 F4C Compensated F4D Decompensated Primary Care + Specialists Specialists (Hep or GI) Hepatologist or Surgeon Manage Cardiometabolic Risk Halt or Improve Fibrosis; Resolve NASH Prevent Liver Failure, HCC, Need for Transplant, Death % of NASH Patients by 20301 ~10-15% ~30-35% ~20-25% ~15-20% ~10-15% <5% Hep, hepatologist; GI, gastroenterologist; HCC, hepatocellular carcinoma. 1. Estes C, et al. Hepatology. 2018 Jan;67(1):123-133.


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Our Stakeholders Are Ready and Waiting for a Therapy Like Rezdiffra March 2024 Madrigal Pharmaceuticals 24 “There is a ticking time bomb inside me, I don’t know when it will go off.” In the treatment of NASH with moderate to advanced fibrosis: ~88% of heps/GIs see a high urgency to treat ~85% of heps/GIs see Rezdiffra offering high clinical utility 89% would proactively seek resmetirom if it were available When seeking a treatment for NASH with moderate to advanced fibrosis: Physicians Patients Payers Vast majority of payers have a good understanding of disease state Nearly 100% viewed need to treat NASH with moderate to advanced fibrosis as high to very high Early insights: No biopsy requirement expected Hep, hepatologist; GI, gastroenterologist. Source: US Quant HCP Research, SRI, n= 172 HCPs, Q4 2023; US Quant HCP Research, ClearView, n=360 HCPs, Q4 2022; US Quant Patient Research, ClearView, n=140 patients, Q3 2021; US Payer Research, ClearView, n=24 payers, Q4 2023


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Establishing Pathway for Blockbuster, First-in-Disease Medicine Educate Physicians Create Treatment Pathway Ensure Access Key Prescription Processing (ME, PA) Reimbursement Goals Established Payer Affordability Fulfillment Engagement Coverage Commercial Decisions (P&T) coverage to ~80% by YE24 Time to fill ICD-10 Rx from Coding ~60 days to Rezdiffra Electronic Treatment ~30 days at Education NASH Medical Guidelines 6 mos. post Education Records launch Noninvasive Testing P&T, pharmacy and therapeutics; ME, medical exception; PA, prior authorization.


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Built a Winning Team Ready for Launch Commercial and Medical leadership team; each with 25+ years industry experience; numerous blockbuster launches Sales Medical Affairs â–ª 17 yrs. experience â–ª 8 yrs. in practice; â–ª Top performers 14 yrs. in industry â–ª Hep/GI experience â–ª M.D.s, Pharm.Ds., Ph.D.s HCPs â–ª Hep/GI experience ~14K hep/GI targets ~6K top treaters Market Access Patient Support â–ª 15 yrs. experience â–ª 18 yrs. experience â–ª Best-in-class HEOR data â–ª Expert support in access and â–ª Robust disease, cost and NIT affordability solutions Key Account Team education leading up to launch â–ª IDNs, large GI/hep health systems â–ª Hep/GI experience Right People, Right Skills, Right Size Hep, hepatologist; GI, gastroenterologist; TA, therapeutic area; NITs, noninvasive tests; IDN, integrated delivery network.


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Rezdiffra Price Delivering a Cost-Effective Therapy Pricing is Grounded in Benefit to Patients and Value to the Health System March 2024 Madrigal Pharmaceuticals 27 WAC, wholesale acquisition cost; 1. O’Hara J, et al. JHEP Rep. 2020 Oct; 2(5): 100142. 2. Qian C, et al. Poster presented at: AMCP Nexus; October 16–19, 2023; Orlando, FL. 3. Fahim SM, et al. J Manag Care Spec Pharm. 2023 Oct;29(10):1169-1172. Targeting a Costly Disease for the Health System 4X Higher cost of cirrhosis vs. halting NASH at F32 ~$120B Annual direct costs of NASH1 $76,000 $39,600 – $50,100 ICER cost-effectiveness assessment ICER cost-effectiveness threshold range3 $47,400 Annual WAC price Price reflects value as first-and-only therapy for NASH


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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 • Patients with no insurance or no Coverage navigation coverage for Rezdiffra may be eligible to receive the medication for free Financial support Direct-to-patient delivery


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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


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Q&A 


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Rezdiffr (resmetirom) FDA Approval Conference Call March 2024 NASDAQ: MDGL © 2024 Madrigal Pharmaceuticals. All rights reserved.