MDGL Madrigal Pharmaceuticals Inc

Fourth-quarter and full-year 2024 Rezdiffra net sales of $103.3 million and $180.1 million, respectively

As of year-end 2024, more than 11,800 patients on Rezdiffra

Reports cash, cash equivalents, restricted cash and marketable securities of $931.3 million at December 31, 2024

Announces new two-year data for the active-treatment open-label compensated MASH cirrhosis (F4c) arm of the Phase 3 MAESTRO-NAFLD-1 trial

Company to host conference call today, February 26, 2025, at 8 a.m. EST

MAESTRO-NAFLD-1 was a double-blind placebo-controlled, randomized Phase 3 safety trial conducted to support regulatory approval of Rezdiffra. The trial includes an active-treatment open-label extension arm in patients with compensated MASH cirrhosis. Madrigal previously reported one-year results for this active treatment arm.

Today, the Company is announcing, two-year results (n=101):

The patient cohort achieved a mean 6.7 kPa reduction in liver stiffness as measured by vibration-controlled transient elastography (VCTE); this represents the largest VCTE reduction reported in an F4c MASH patient population to date. This reduction was statistically significant as compared to baseline.

51% of patients achieved a ≥ 25% reduction in liver stiffness as measured by VCTE. A reduction of this magnitude has been associated with reduced progression to end-stage liver disease.

Rezdiffra’s safety and tolerability profile was consistent with other Rezdiffra clinical trials with a low discontinuation rate due to adverse events.

Madrigal plans to present these data and additional findings from the active-treatment open-label cirrhosis arm of the MAESTRO-NAFLD-1 trial at a future medical meeting.

The results further support the potential benefit of Rezdiffra in patients with compensated MASH cirrhosis and the potential success of the ongoing MAESTRO-NASH OUTCOMES trial, a double blind, placebo-controlled, event-driven trial in F4c, for which data are anticipated in 2027.

Landmark FDA approval of Rezdiffra

In February 2024, Rezdiffra Phase 3 MAESTRO-NASH trial 52-week results were published in The New England Journal of Medicine; the paper was subsequently chosen as one of the journal’s 14 notable scientific research articles of 2024.

In March 2024, Madrigal announced FDA approval of Rezdiffra for the treatment of adults with noncirrhotic MASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis).

In April 2024, Rezdiffra became commercially available as the first and only approved therapy for MASH.

Expert guidelines recommend Rezdiffra as first-line therapy for MASH

In June 2024, the European Association for the Study of the Liver (EASL) Congress updated their practice guidelines to recommend Rezdiffra as a first-line therapy for MASH, subject to regulatory approval in Europe.

In October 2024, the American Association for the Study of Liver Diseases (AASLD), a leading organization of scientists and health care professionals committed to preventing and curing liver disease, updated their practice guidelines to recommend Rezdiffra as a first-line therapy for MASH and implemented recommendations regarding its use for clinicians.

Driving future growth through European expansion

In March 2024, Madrigal announced that the marketing authorization application (MAA) for resmetirom for the treatment of MASH with liver fibrosis was validated and is under evaluation with the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). The CHMP opinion and subsequent European Union (EU) decision is expected in mid-2025.

Madrigal expects to launch Rezdiffra in Europe on a country-by-country basis commencing with Germany in the second half of 2025, pending EMA approval, which would make it the first approved therapy for patients with MASH liver fibrosis in Europe.

Driving future growth through indication expansion

In October 2024, Madrigal announced completion of enrollment in the MAESTRO-NASH OUTCOMES trial, an event-driven trial evaluating Rezdiffra in patients with F4c, an advanced and underserved patient population. Positive results could position Rezdiffra to become the only treatment for F2 to F4c MASH and the only therapy with outcomes data in MASH this decade.

Strong presence at key liver meetings

In June 2024, Madrigal presented 10 abstracts at the EASL congress, including noninvasive test (NIT) data that demonstrated 91% of patients achieved improvement or stabilization of liver stiffness out to three years.

In November 2024, Madrigal had a significant presence at the AASLD Liver Meeting. Eleven Madrigal abstracts were presented at the meeting, including two oral presentations of new analyses from the Phase 3 MAESTRO-NASH trial of Rezdiffra.

Total revenues: The Company generated fourth-quarter and full-year 2024 net revenues of $103.3 million and $180.1 million, respectively. No product sales were recognized during the comparable prior year period.

Operating Expenses: Fourth-quarter and full-year 2024 operating expenses were $170.3 million and $678.0 million, respectively, compared to $117.2 million and $380.5 million in the comparable prior year periods.

Cost of sales: Fourth-quarter and full-year 2024 cost of sales were $3.4 million and $6.2 million, respectively. Cost of sales were not recognized during the comparable prior year periods given that no product sales were recorded.

R&D Expense: Fourth-quarter and full-year 2024 R&D expense was $25.6 million and $236.7 million, respectively, compared to $70.6 million and $272.4 million in the comparable prior year periods. Research and development expenses decreased by $35.6 million in 2024 due primarily to a reduction in clinical trial accruals and the change in accounting for inventory costs following FDA approval of Rezdiffra in March 2024, partially offset by increases in headcount.

SG&A Expense: Fourth-quarter and full-year 2024 SG&A expense was $141.2 million and $435.1 million, respectively, compared to $46.5 million and $108.1 million in the comparable prior year periods. Selling, general and administrative expenses increased by $326.9 million in 2024 due primarily to increases for commercial launch activities for Rezdiffra, including a corresponding increase in headcount, and an increase in stock compensation expense.

Interest Income: Fourth-quarter and full-year 2024 interest income was $11.1 million and $46.7 million, respectively, compared to $9.0 million and $19.6 million in the comparable prior year periods. The increase in interest income was due primarily to higher principal balances and interest rates in 2024.

Interest Expense: Fourth-quarter and full-year 2024 interest expense was $3.5 million and $14.7 million, respectively, compared to $4.0 million and $12.7 million in the comparable prior year periods. The increase in interest expense in 2024 was primarily the result of a higher average outstanding principal balance during the period under the Madrigal’s loan facility.

Cash, Cash Equivalents, Restricted Cash and Marketable Securities: As of December 31, 2024, Madrigal had cash, cash equivalents, restricted cash and marketable securities of $931.3 million, compared to $634.1 million at December 31, 2023. This increase was primarily attributable to the $659.9 million of net proceeds we received from our underwritten public offering in March 2024.

have any liver problems other than NASH.

have gallbladder problems or have been told you have gallbladder problems, including gallstones.

are pregnant or plan to become pregnant. It is not known if Rezdiffra will harm your unborn baby.

are breastfeeding or plan to breastfeed. It is not known if Rezdiffra passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Rezdiffra.

Rezdiffra and other medicines may affect each other, causing side effects. Rezdiffra may affect the way other medicines work, and other medicines may affect how Rezdiffra works.

Especially tell your healthcare provider if you take medicines that contain gemfibrozil to help lower your triglycerides, or cyclosporine to suppress your immune system, because Rezdiffra is not recommended in patients taking these medicines.

Tell your healthcare provider if you are taking medicines such as clopidogrel to thin your blood or statin medicines to help lower your cholesterol.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

liver injury (hepatotoxicity). Stop taking Rezdiffra and call your healthcare provider right away if you develop the following signs or symptoms of hepatotoxicity: tiredness, nausea, vomiting, fever, rash, your skin or the white part of your eyes turns yellow (jaundice), pain or tenderness in the upper middle or upper right area of your stomach (abdomen).

gallbladder problems. Gallbladder problems such as gallstones, inflammation of the gallbladder, or inflammation of the pancreas from gallstones can occur with NASH and may occur if you take Rezdiffra. Call your healthcare provider right away if you develop any signs or symptoms of these conditions including nausea, vomiting, fever, or pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen to your back and the pain may happen with or without vomiting.

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