Madrigal Pharmaceuticals, Inc.: Q4 FY2025 earnings call

What management said about Q4 FY2025, from the documents filed with the SEC on 19 February 2026: press release. Guidance figures: 2 new, 1 kept. The quarter’s numbers.

Read the filing

Key takeaways

• Revenue rose sharply on a year earlier: Fourth-quarter revenue was $321.1 million, against $103.3 million a year earlier and $287.3 million in the third quarter. Full-year revenue was $958.4 million, up from $180.1 million. Source
• Patients on Rezdiffra passed 36,250: More than 36,250 patients were on Rezdiffra at year-end 2025, up from more than 29,500 at September 30, 2025. More than 10,000 healthcare providers were prescribing it as of the third quarter. Source
• Operating expenses rose on commercial and R&D: Fourth-quarter operating expenses were $380.7 million against $170.3 million a year earlier. Full-year operating expenses were $1,258.5 million against $678.0 million. Source
• Cash ended year near $1 billion: Cash, cash equivalents, restricted cash and marketable securities were $988.6 million at December 31, 2025, against $931.3 million a year earlier and $1.1 billion at September 30. Source
• Ervogastat cut liver fat in Phase 2: In Phase 2 MRI-PDFF data at 150mg, 72% of patients reached at least a 30% liver fat reduction and 61% reached at least a 50% reduction. Source
• Two-year F4c data showed risk shifts: Two-year open-label extension data in compensated cirrhosis showed improved liver stiffness, fibrosis biomarkers and portal hypertension risk markers. 65% of patients with CSPH at baseline moved to lower risk categories by year two. Source
• CEO set three priorities: Chief Executive Officer Bill Sibold listed first-to-market outcomes data in F4c, further evidence on Rezdiffra's benefits, and combination medicines anchored by Rezdiffra. Source

“2025 marked a defining year for Madrigal. We solidified our position as the undisputed leader in MASH highlighted by nearly $1 billion in Rezdiffra sales in its first full year of launch.”

Bill Sibold, Chief Executive Officer of Madrigal

Guidance

What changed from last quarter

• New: Licensed global rights to six pre-clinical siRNA programs for a genetically targeted approach to MASH, to be used alongside Rezdiffra. Source
• New: Exclusive global license agreement for ervogastat, a phase 2 oral DGAT-2 inhibitor, added to the MASH pipeline. Source
• New: Two-year data from the active-treatment open-label extension F4c cohort of the NAFLD-1 trial were presented at EASL and AASLD. Source

Revenue and patient growth

• Revenue rose sharply on a year earlier: Fourth-quarter revenue was $321.1 million, against $103.3 million a year earlier and $287.3 million in the third quarter. Full-year revenue was $958.4 million, up from $180.1 million. Source
• Patients on Rezdiffra passed 36,250: More than 36,250 patients were on Rezdiffra at year-end 2025, up from more than 29,500 at September 30, 2025. More than 10,000 healthcare providers were prescribing it as of the third quarter. Source
• Target population still largely untreated: Management focuses on about 315,000 patients with moderate to advanced fibrosis under liver specialist care in the U.S. It said the company has penetrated only a fraction of the market. Source

Germany launch and EU status

• Germany launch followed EC approval: Rezdiffra launched in Germany in September 2025, following European Commission conditional marketing authorization in August 2025. Source
• First and only EU therapy for MASH: The company describes Rezdiffra as the first and only approved therapy in the European Union for MASH. Source
• EC authorization rested on MAESTRO-NASH: The conditional authorization was based on pivotal Phase 3 MAESTRO-NASH results, which showed reduced fibrosis, resolved MASH and improved key noninvasive tests. Source

“We believe 2026 will be even more exciting where we expect another year of robust net sales growth driven by broad first-line access, increasing disease awareness and the outstanding real-world experience with Rezdiffra reported by patients and providers.”

Bill Sibold, Chief Executive Officer of Madrigal

Operating expense lines

• Operating expenses rose on commercial and R&D: Fourth-quarter operating expenses were $380.7 million against $170.3 million a year earlier. Full-year operating expenses were $1,258.5 million against $678.0 million. Source
• SG&A rose on commercial build-out: Full-year SG&A was $813.8 million against $435.1 million. Fourth-quarter SG&A was $240.0 million against $141.2 million. Source
• R&D rose on business development upfronts: Full-year R&D was $388.5 million against $236.7 million. Fourth-quarter R&D was $116.3 million against $25.6 million. Lower clinical trial expenses partly offset the increase. Source
• Cost of sales increased year over year: Full-year cost of sales was $56.1 million against $6.2 million. Fourth-quarter cost of sales was $24.4 million against $3.4 million. Source

Cash, debt and interest

• Cash ended year near $1 billion: Cash, cash equivalents, restricted cash and marketable securities were $988.6 million at December 31, 2025, against $931.3 million a year earlier and $1.1 billion at September 30. Source
• July credit facility funded the year: The company entered a senior secured facility with Blue Owl Capital in July 2025, with a $350 million initial term loan funded at closing. Part of it repaid the earlier loan. Source
• Interest expense rose on larger principal: Interest expense was $8.3 million in the fourth quarter against $3.5 million, and $22.3 million for the year against $14.7 million, reflecting the higher principal after the July 2025 facility. Source
• Interest income declined year over year: Interest income was $9.5 million in the fourth quarter against $11.1 million, and $37.4 million for the year against $46.7 million. Source

“Just a year ago, we were a single-product company, and today we have a pipeline with more than 10 programs that we believe will define the future of MASH treatment.”

Bill Sibold, Chief Executive Officer of Madrigal

Pipeline licences and deals

• Six siRNA programs licensed: Six pre-clinical siRNA programs were licensed to reduce disease-driving proteins at the genetic level, to test whether they complement Rezdiffra. IND-enabling work begins in 2026. Source
• Ervogastat added as DGAT-2 partner: The company holds an exclusive global license for ervogastat, a phase 2 oral DGAT-2 inhibitor. It describes DGAT-2 inhibition as a mechanism complementary to Rezdiffra. Source
• Oral GLP-1 combination nears clinic: MGL-2086, an oral GLP-1 receptor agonist licensed for combination use with Rezdiffra, is expected to enter the clinic in the second quarter of 2026. Source

Clinical data and trials

• Ervogastat cut liver fat in Phase 2: In Phase 2 MRI-PDFF data at 150mg, 72% of patients reached at least a 30% liver fat reduction and 61% reached at least a 50% reduction. Source
• Two-year F4c data showed risk shifts: Two-year open-label extension data in compensated cirrhosis showed improved liver stiffness, fibrosis biomarkers and portal hypertension risk markers. 65% of patients with CSPH at baseline moved to lower risk categories by year two. Source
• Phase 3 outcomes trial ongoing in F4c: The Phase 3 outcomes trial is evaluating Rezdiffra in compensated MASH cirrhosis (F4c). It is ongoing, with topline data expected in 2027. Source

Approvals and patent protection

• Orange Book patent protects into 2045: A new Orange Book listed patent for Rezdiffra was secured, providing protection into 2045. Source
• Patent claims cover label dosing: The listed patent's claims are directed to Rezdiffra's commercial weight-threshold dosing regimen as prescribed in the FDA-approved label. Source
• Approved by FDA and European Commission: Rezdiffra is approved by both the FDA and the European Commission for MASH with moderate to advanced fibrosis (F2 to F3). Source

Management priorities and pipeline

• CEO set three priorities: Chief Executive Officer Bill Sibold listed first-to-market outcomes data in F4c, further evidence on Rezdiffra's benefits, and combination medicines anchored by Rezdiffra. Source
• Combination medicines as next phase: Sibold said the company aims to usher in combination medicines with Rezdiffra as the foundation, addressing the full range of patient needs. Source
• Pipeline grew from a single product: Sibold contrasted the company's single-product position a year earlier with a pipeline of more than 10 programs. Source

Coming up, as management said on 19 February 2026

• MGL-2086 enters clinic: The oral GLP-1 candidate is expected to enter the clinic in the second quarter of 2026. Source
• Drug interaction study and combination trial design: The company plans a drug-to-drug interaction study with Rezdiffra this year, and will consult the FDA on the design of a Phase 2 combination trial. Source
• SiRNA IND-enabling work starts: IND-enabling activities for the initial siRNA candidates are to begin in 2026. Source
• MAESTRO-NASH OUTCOMES topline readout: Topline data from the ongoing MAESTRO-NASH OUTCOMES trial are expected in 2027. Source

Figures management reported

Risks management discussed

• Demand: A poster analysis found that patients who paused Rezdiffra therapy reversed earlier gains, which management said underscores the need for sustained therapy. Source

Earlier plans management reported on

• Not stated: Clinic entry for MGL-2086 is now given for the second quarter of 2026, against the first half of 2026 stated in the prior quarter. Source
• Not stated: The prior quarter said Rezdiffra was poised for growth and broad first-line access in 2026. The current release repeats the expectation of growth.

Other quarters

• Q3 FY2026 earnings call
• Q2 FY2026 earnings call
• Q1 FY2026 earnings call
• Q3 FY2025 results

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.