Madrigal Pharmaceuticals, Inc.: Q3 FY2026 earnings call

What management said about Q3 FY2026, from the documents filed with the SEC on 3 November 2026: press release. Guidance figures: 4 new. The quarter’s numbers.

Key takeaways

Net revenues up 50% year over year: Net revenues were $431.3 million, up from $287.3 million a year earlier. The prior release reported $364.3 million for second-quarter 2026. Source
First quarter of profitability reported: Management said the company achieved its first quarter of profitability. Net income was $55.4 million, or $1.83 per diluted share, compared with a net loss a year earlier. Source
Rezdiffra passes $1 billion year-to-date: Year-to-date Rezdiffra net sales reached $1.1 billion, which management described as blockbuster status. Source
Patients on Rezdiffra nearly doubled: More than 55,850 patients were on Rezdiffra as of Sept. 30, 2026, nearly doubling the count from third-quarter 2025. Source
Cost of sales rose on Roche royalties: Cost of sales was $37.8 million, against $18.1 million a year earlier. Management attributed the increase to higher royalties payable to Roche on increased Rezdiffra sales. Source
F4c cirrhosis leadership with MAESTRO-CSPH: Management said the new MAESTRO-CSPH Phase 3 outcomes trial strengthens leadership in well-compensated MASH cirrhosis (F4c), with enrollment of more than 2,000 patients. Source

“Rezdiffra surpassed $1 billion in year-to-date net sales, achieving blockbuster status less than three years after launch, and we are still early in a rapidly growing market.”
Bill Sibold, Chief Executive Officer of Madrigal

Guidance

Area	Period	Figure	Against last quarter
F2-F3 MASH market growth Source	year-end 2026 (YE26)	more than 30% growth	New
MAESTRO-NASH OUTCOMES data timing Source	late 2027	late 2027	New
MAESTRO-CSPH trial initiation Source	first half of 2027	first half of 2027	New
MAESTRO-CSPH enrollment Source	MAESTRO-CSPH trial	more than 2,000 F4c patients	New

What changed from last quarter

New: Management said it plans to initiate MAESTRO-CSPH, a second Phase 3 event-driven outcomes trial building on the ongoing MAESTRO-NASH OUTCOMES study. Source
New: John C. Reed, M.D., Ph.D., was appointed to the Board of Directors in August. Source

Results and growth drivers

Net revenues up 50% year over year: Net revenues were $431.3 million, up from $287.3 million a year earlier. The prior release reported $364.3 million for second-quarter 2026. Source
First quarter of profitability reported: Management said the company achieved its first quarter of profitability. Net income was $55.4 million, or $1.83 per diluted share, compared with a net loss a year earlier. Source
Rezdiffra passes $1 billion year-to-date: Year-to-date Rezdiffra net sales reached $1.1 billion, which management described as blockbuster status. Source

Rezdiffra patients and market

Patients on Rezdiffra nearly doubled: More than 55,850 patients were on Rezdiffra as of Sept. 30, 2026, nearly doubling the count from third-quarter 2025. Source
Patient count at June 30: The prior release reported more than 49,000 patients on Rezdiffra as of June 30, 2026, more than double the second-quarter 2025 count.
Addressable F2-F3 market keeps growing: Management said the U.S. F2-F3 MASH market is accelerating, with more than 530,000 addressable patients through June 30, 2026. Source

“Our objective in F4c is clear: be first and best.”
Bill Sibold, Chief Executive Officer of Madrigal

Costs and margins

Cost of sales rose on Roche royalties: Cost of sales was $37.8 million, against $18.1 million a year earlier. Management attributed the increase to higher royalties payable to Roche on increased Rezdiffra sales. Source
Second-quarter write-down in cost of sales: The prior release said second-quarter cost of sales also included a write-down of certain work-in-process inventory, alongside higher Roche royalties.
R&D spending fell from prior-year charge: R&D expenses were $71.8 million, against $174.0 million. The prior-year figure included a one-time, upfront business development expense of $117.3 million. Source
SG&A rose on commercial investment: SG&A expenses were $265.7 million, against $209.1 million a year earlier, reflecting continued investment in Rezdiffra commercial activities, including headcount. Source
Total operating expenses declined year over year: Operating expenses were $375.3 million, including $38.9 million of non-cash stock-based compensation, versus $401.2 million a year earlier. Source

Pipeline and evidence

Genetic variant analysis published: A secondary analysis of MAESTRO-NASH, published in the Journal of Hepatology, reported Rezdiffra improved histology and MRI-PDFF across common MASH genetic variants. Source
Large abstract presence at AASLD: Management said 18 Madrigal abstracts were accepted for the AASLD Liver Meeting, 13 based on real-world evidence, with the largest dataset covering nearly 12,000 patients. Source
MGL-2086 combination dosing began: The prior release said Phase 1 dosing of MGL-2086, an oral GLP-1, began in June 2026 as part of the Rezdiffra combination program in MASH.

“Our latest analysis shows the addressable U.S. F2-F3 market is on track to increase more than 30 percent by year-end 2026, reinforcing how quickly this category is developing and the significant runway ahead.”
Bill Sibold, Chief Executive Officer of Madrigal

Cash position

Cash balance $961.8 million at quarter-end: Cash, cash equivalents, restricted cash and marketable securities were $961.8 million at Sept. 30, 2026, compared with $988.6 million at Dec. 31, 2025. Source
Cash higher than at June 30: The prior release reported $838.9 million at June 30, 2026, so the balance was $122.9 million higher at Sept. 30, 2026.
Second-quarter net loss reported: The prior release reported a second-quarter net loss of $57.9 million, or $1.99 per share, including $25.0 million of one-time upfront business development expense.

Strategy and leadership

F4c cirrhosis leadership with MAESTRO-CSPH: Management said the new MAESTRO-CSPH Phase 3 outcomes trial strengthens leadership in well-compensated MASH cirrhosis (F4c), with enrollment of more than 2,000 patients. Source
Dr. John Reed joins the board: John C. Reed, M.D., Ph.D., was appointed to the board in August. He is Executive Vice President, Innovative Medicine, Research & Development at Johnson & Johnson. Source
Patent portfolio strengthened: The prior release said three new resmetirom patents were issued, covering the F2-F3 label and F4c, with protection expected into 2042 and 2045.

Coming up, as management said on 3 November 2026

AASLD Liver Meeting presence: Management said Madrigal will have a significant presence at the AASLD Liver Meeting, Nov. 5-9 in Denver, with resmetirom featured in more abstracts than any other MASH therapy. Source

Figures management reported

Figure	Reported
Net revenues, third quarter 2026 Source	$431.3 million
Rezdiffra year-to-date net sales Source	$1.1 billion
R&D expenses, third quarter 2026 Source	$71.8 million
Pipeline milestone: MAESTRO-CSPH initiation Source	first half of 2027
Trial readout: MAESTRO-NASH OUTCOMES data Source	late 2027

Earlier plans management reported on

On track: Management said the MAESTRO-NASH OUTCOMES trial is on track, with data expected in late 2027. Source
On track: Management said the U.S. F2-F3 MASH market is on track for more than 30% growth by YE26. Source

Other quarters

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.

As filed with the SEC

Open the filing on EDGAR

Madrigal Pharmaceuticals Reports Third-Quarter 2026 Financial Results and Provides Corporate Updates

Third-quarter 2026 Rezdiffra® (resmetirom) net sales of $431.3 million, representing year-over-year growth of 50%; achieved first quarter of profitability
Rezdiffra reaches a major milestone, achieving blockbuster status with year-to-date net sales of $1.1 billion
As of Sept. 30, 2026, more than 55,850 patients on Rezdiffra, nearly doubling from 3Q25, reflecting continued strong prescriber adoption and high patient demand
U.S. F2-F3 MASH market is accelerating, growing to more than 530,000 addressable patients through June 30, 2026, on track for more than 30% growth by YE26
Madrigal strengthens its leadership position in well-compensated MASH cirrhosis (F4c) with new MAESTRO-CSPH outcomes clinical trial; MAESTRO-NASH OUTCOMES on track, data expected late 2027
Reports cash, cash equivalents, restricted cash and marketable securities of $961.8 million as of Sept. 30, 2026
Appointed John C. Reed, M.D., Ph.D., to Board of Directors
Company to host conference call today, Nov. 3, 2026, at 8 a.m. EST

CONSHOHOCKEN, Pa., Nov. 3, 2026 - Madrigal Pharmaceuticals, Inc. (Nasdaq: MDGL), a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), today reports third-quarter 2026 financial results and provides corporate updates.

Bill Sibold, Chief Executive Officer of Madrigal, stated: “Madrigal delivered another strong quarter, driven by continued Rezdiffra demand, deepening prescriber adoption and accelerating market growth. Rezdiffra surpassed $1 billion in year-to-date net sales, achieving blockbuster status less than three years after launch, and we are still early in a rapidly growing market. Our latest analysis shows the addressable U.S. F2-F3 market is on track to increase more than 30 percent by year-end 2026, reinforcing how quickly this category is developing and the significant runway ahead.”

Sibold continued: “Madrigal’s next major opportunity is in well-compensated cirrhosis, or F4c, an urgent unmet need for patients. Our objective in F4c is clear: be first and best. Our ongoing MAESTRO-NASH OUTCOMES trial positions us to deliver the first approved therapy to patients with this advanced stage of MASH. MAESTRO-CSPH is our new, Phase 3, practice-shaping trial that we expect will extend our competitive advantage and strengthen our long-term leadership in this rapidly growing market.”

Third Quarter 2026 and Recent Corporate Updates

Strengthens leadership in well-compensated MASH cirrhosis (F4c) with new MAESTRO-CSPH Phase 3 outcomes trial

oMadrigal plans to initiate MAESTRO-CSPH, a second Phase 3 event-driven outcomes trial that builds on its ongoing MAESTRO-NASH OUTCOMES study. The trial is expected to enroll more than 2,000 F4c patients, with a population significantly enriched for clinically significant portal hypertension (CSPH). It is designed to generate the broadest dataset in F4c and support validation of noninvasive biomarkers for Rezdiffra and future pipeline programs. Trial initiation is expected in the first half of 2027, subject to regulatory discussions.

Madrigal to have strong presence at upcoming AASLD Liver Meeting

oMadrigal will have a significant presence at the upcoming American Association for the Study of Liver Diseases (AASLD) Liver Meeting taking place Nov. 5-9 in Denver, CO. Resmetirom will be featured in more abstracts than any other MASH therapy at the conference. Eighteen Madrigal abstracts have been accepted, including 13 abstracts based on real-world evidence where the largest data set spans nearly 12,000 patients, underscoring the breadth of Madrigal’s evidence-generation program for Rezdiffra and MASH.

Journal of Hepatology publication demonstrates Rezdiffra’s consistent efficacy across common MASH genetic risk variants

oSecondary analysis of the Phase 3 MAESTRO-NASH trial demonstrated Rezdiffra improved histology and MRI-PDFF across common genetic variants associated with MASH progression including PNPLA3, HSD17B13, TM6SF2, MTARC1 and MBOAT7, reinforcing Rezdiffra as a foundational treatment.

Appointed John C. Reed, M.D., Ph.D., to Madrigal’s Board of Directors

oIn August, Dr. John Reed was appointed to Madrigal’s Board of Directors. Currently Dr. Reed serves as Executive Vice President, Innovative Medicine, Research & Development at Johnson & Johnson where he leads research and development across oncology, immunology and neuroscience. He previously held executive leadership positions at both Sanofi and Roche.

Third-Quarter 2026 Financial Results

Total Revenues: Third-quarter 2026 net revenues were $431.3 million, an increase of 50% compared to $287.3 million in the comparable prior year period, driven by increased demand for Rezdiffra in the U.S. in 2026.
Operating Expenses: Third-quarter 2026 operating expenses were $375.3 million, inclusive of $38.9 million in non-cash stock-based compensation expense, compared to $401.2 million, inclusive of $26.3 million in non-cash stock-based compensation expense, in the comparable prior year period.

oCost of Sales: Third-quarter 2026 cost of sales was $37.8 million compared to $18.1 million in the comparable prior year period. The increase in cost of sales was primarily driven by higher royalties payable to Roche as a result of increased net sales of Rezdiffra in 2026.

oR&D Expenses: Third-quarter 2026 R&D expenses were $71.8 million compared to $174.0 million in the comparable prior year period, both inclusive of non-cash stock-based compensation. The decrease in R&D expenses was primarily due to the one-time, upfront business development expense of $117.3 million in the comparable prior year period.

oSG&A Expenses: Third-quarter 2026 SG&A expenses were $265.7 million compared to $209.1 million in the comparable prior year period, both inclusive of non-cash stock-based compensation. The increase in SG&A expenses was primarily due to continued investment in commercial activities for Rezdiffra, including headcount for the endocrinology field force expansion that began in the fourth quarter of 2025, and marketing efforts, including a direct-to-consumer (DTC) campaign.

Net Income: Third-quarter 2026 net income was $55.4 million, or $1.90 per basic share and $1.83 per diluted share, compared to a net loss of $114.2 million, or $4.01 per basic and diluted share, in the comparable prior year period.
Cash, Cash Equivalents, Restricted Cash and Marketable Securities: As of Sept. 30, 2026, Madrigal had cash, cash equivalents, restricted cash, and marketable securities of $961.8 million compared to $988.6 million as of Dec. 31, 2025.

Conference Call and Webcast

At 8 a.m. EST today, Nov. 3, 2026, Madrigal will host a webcast to review its financial and operating results and provide a general business update. To access the webcast, please visit the investor relations section of the Madrigal website or click here to register. An archived webcast will be available on the Madrigal website following the event.

About MASH

Metabolic dysfunction-associated steatohepatitis (MASH) is a serious liver disease that can progress to cirrhosis, liver failure, liver cancer, the need for liver transplantation, and premature mortality. MASH is the leading cause of liver transplantation in women and the second leading cause of all liver transplantation in the U.S. It is the fastest-growing indication for liver transplantation in Europe.

Once patients progress to MASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis), the risk of adverse liver outcomes increases dramatically: these patients have a 10 to 17 times higher risk of liver-related mortality as compared to patients without fibrosis. Patients with MASH who progress to cirrhosis face a 42 times higher risk of liver-related mortality, underscoring the need to treat MASH before complications of cirrhosis develop. MASH is also an independent driver of cardiovascular disease, the leading cause of mortality for patients.

As disease awareness improves and disease prevalence increases, the number of diagnosed patients with F2 to F4c MASH is growing.

About Madrigal

Madrigal Pharmaceuticals, Inc. (Nasdaq: MDGL) is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a liver disease with high unmet medical need. Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra was the first medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c). For more information, visit www.madrigalpharma.com.

Forward Looking Statements

Forward-looking statements notice

This press release includes “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended, including statements related to the expected growth of Rezdiffra, expected growth of the MASH market, Madrigal’s leadership position in the MASH sector, the potential benefit of resmetirom in patients with compensated MASH cirrhosis, the expected receipt of data from the MAESTRO-NASH OUTCOMES trial in late 2027, the expected initiation of the MAESTRO-CSPH trial in the first half of 2027, the potential impact of positive results from Madrigal’s outcomes trials, expectations regarding competitor trials and the potential benefit of Madrigal’s pipeline candidates in the treatment of MASH. Forward-looking statements are based on Madrigal’s beliefs and assumptions on information currently available to it and are subject to a number of risks and uncertainties including, but not limited to: the assumptions underlying the forward-looking statements; Madrigal’s ability to successfully commercialize Rezdiffra in the U.S. and Europe; conditions imposed by regulators relating to the scope and design of Madrigal’s clinical trials; risks related to obtaining and maintaining regulatory approvals, including, but not limited to, potential regulatory delays or rejections; Madrigal’s history of operating losses and the possibility that it may never achieve or maintain consistent profitability; risks associated with meeting the objectives of Madrigal’s clinical trials, including, but not limited to the ability to achieve enrollment objectives concerning patient numbers (including an adequate safety database), outcomes objectives and/or timing objectives for Madrigal’s trials; 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 or of any other product candidate; market demand for and acceptance of Rezdiffra; Madrigal’s ability to service indebtedness and otherwise comply with debt covenants; outcomes or trends from competitors; future topline data timing or results; Madrigal’s ability to prevent and/or mitigate cyber-attacks; Madrigal’s ability to protect its intellectual property rights; the uncertainties inherent in clinical testing; uncertainties concerning analyses or assessments outside of a controlled clinical trial; and changes in laws and regulations applicable to Madrigal’s business and its ability to comply with such laws and regulations. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Except as required by applicable law, 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 reports filed with the U.S. Securities and Exchange Commission (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, 2025, and as updated from time to time by Madrigal’s other filings with the SEC.

Madrigal may use its website to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor Madrigal’s website in addition to following its press releases, filings with the SEC, public conference calls, and webcasts.

Madrigal Pharmaceuticals, Rezdiffra® and associated logos are trademarks of Madrigal Pharmaceuticals, Inc.

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Contacts
Tina Ventura, IR@madrigalpharma.com
Christopher Frates, media@madrigalpharma.com