Madrigal Pharmaceuticals, Inc.: Q1 FY2026 earnings call

What management said about Q1 FY2026, from the documents filed with the SEC on 6 May 2026: press release. Guidance figures: 3 kept. The quarter’s numbers.

Key takeaways

Rezdiffra sales rose 127%: Rezdiffra net sales were $311.3 million, up 127% year over year. Total net revenues were also $311.3 million, compared with $137.3 million in the prior-year period. Source
Patients on Rezdiffra up 2.5 times: More than 42,250 patients were on Rezdiffra as of March 31, 2026, up 2.5 times from first-quarter 2025, according to the company. Source
One-time upfront expense of $54.3 million: Operating expenses included one-time, upfront business development expenses of $54.3 million for strategic pipeline expansion, equal to $1.87 per share of net loss. Source
Cash balance fell to $817.9 million: Cash, cash equivalents, restricted cash and marketable securities were $817.9 million at March 31, 2026, against $988.6 million at December 31, 2025. Source
Licensed clinical-stage PNPLA3 siRNA: Madrigal licensed global rights to ARO-PNPLA3 from Arrowhead, a clinical-stage GalNAc-conjugated siRNA designed to reduce PNPLA3 expression. Source

“We’re continuing to steadily add patients, reinforcing our confidence in our robust growth expectations for Rezdiffra in 2026.”
Bill Sibold, Chief Executive Officer of Madrigal

Guidance

Area	Period	Figure	Against last quarter
MGL-2086 oral GLP-1 Phase 1 trial start Source	2Q26	on track to initiate in 2Q26	Kept
Ervogastat/resmetirom drug-drug interaction study start Source	4Q26	on track to initiate in 4Q26	Kept
Rezdiffra intellectual property protection Source	into 2045	expected into 2045	Kept

What changed from last quarter

New: Madrigal licensed global rights to ARO-PNPLA3, a clinical-stage siRNA from Arrowhead, announced May 5. Source
Guidance kept: Rezdiffra 2026 growth expectation is described as robust, the same wording used in the prior quarter. Source
Guidance kept: MGL-2086 Phase 1 start timing remains 2Q26, as in the prior quarter. Source

Results and growth drivers

Rezdiffra sales rose 127%: Rezdiffra net sales were $311.3 million, up 127% year over year. Total net revenues were also $311.3 million, compared with $137.3 million in the prior-year period. Source
Patients on Rezdiffra up 2.5 times: More than 42,250 patients were on Rezdiffra as of March 31, 2026, up 2.5 times from first-quarter 2025, according to the company. Source
Trailing sales reached blockbuster level: Management said Rezdiffra reached blockbuster status on a trailing-12-month net sales basis, linking this to broad physician adoption and high patient demand. Source

Costs, net loss and cash

Net loss widened to $94.4 million: Net loss was $94.4 million, or $3.25 per diluted share, against $73.2 million, or $2.61 per share, a year earlier. Source
One-time upfront expense of $54.3 million: Operating expenses included one-time, upfront business development expenses of $54.3 million for strategic pipeline expansion, equal to $1.87 per share of net loss. Source
R&D rose on upfront expense: R&D expenses were $108.7 million against $44.2 million. The company said the increase was primarily due to the one-time upfront business development expenses. Source
Operating expenses and cost of sales rose: Operating expenses were $404.1 million, including $34.0 million of non-cash stock-based compensation, against $216.6 million. Cost of sales was $26.8 million against $4.5 million. Source
SG&A rose on commercial investment: SG&A expenses were $268.5 million against $167.9 million, mainly from commercial activities including the endocrinology field force and marketing such as a direct-to-consumer campaign. Source
Cash balance fell to $817.9 million: Cash, cash equivalents, restricted cash and marketable securities were $817.9 million at March 31, 2026, against $988.6 million at December 31, 2025. Source

“This new asset advances our strategy to develop next-generation combination therapies across the spectrum of disease.”
Bill Sibold, Chief Executive Officer of Madrigal

Pipeline and licensed asset

Licensed clinical-stage PNPLA3 siRNA: Madrigal licensed global rights to ARO-PNPLA3 from Arrowhead, a clinical-stage GalNAc-conjugated siRNA designed to reduce PNPLA3 expression. Source
Asset targets homozygous PNPLA3 mutation: ARO-PNPLA3 targets MASH patients homozygous for a PNPLA3 mutation, which the company said is highly prevalent among Hispanic patients and represents about 30% of patients with moderate to advanced fibrosis. Source
Phase 1 showed up to 46% liver fat cut: Phase 1 data showed up to a 46% reduction in liver fat by MRI-PDFF at 12 weeks after a single dose, at the highest dose tested in PNPLA3 I148M homozygous patients. Source
Six preclinical siRNA programs underway: Six siRNA programs added in February 2026 are preclinical, and the company said preclinical development is underway. Source

Medical evidence and meetings

Lp(a) and LDL-C reduction analysis: A secondary analysis of MAESTRO-NASH/NAFLD1 trials reports Rezdiffra reduced Lp(a) and LDL-C, which management said supports potential cardiovascular risk reduction independent of baseline statin use. Source
Real-world posters cover up to one year: Two posters share real-world efficacy data for patients on Rezdiffra for up to one year. Source
Described as only approved liver-directed therapy: Management described Rezdiffra as the only approved liver-directed therapy for MASH, citing its differentiated clinical profile. Source

“With our strong cash position and intellectual property protection for Rezdiffra expected into 2045, we are well-positioned to maintain our leadership in MASH”
Bill Sibold, Chief Executive Officer of Madrigal

Market size and demand

MASH market grew to 460,000 patients: Management said the market expanded nearly 50 percent to about 460,000 patients in two years. Source
Market dynamics described as favorable: Management said market dynamics are favorable for 2026 and for long-term growth, citing high unmet need in a rapidly growing market. Source
Diagnosed patient pool growing: The company said the number of diagnosed patients with F2 to F4c MASH is growing as disease awareness improves and prevalence increases. Source

Strategy and intellectual property

Combination therapies across disease spectrum: Management said the siRNA asset advances its strategy to develop next-generation combination therapies across the spectrum of disease. Source
Rezdiffra protection expected into 2045: Management said intellectual property protection for Rezdiffra is expected into 2045, cited alongside its cash position. Source
Leadership tied to commercial and pipeline: Management tied its MASH leadership to growing commercial success and an expanding pipeline, which it described as industry-leading. Source

Coming up, as management said on 6 May 2026

EASL Congress presentations in May: Eight abstracts are to be presented at the EASL Congress in Barcelona, May 27-30, 2026. Source

Figures management reported

Figure	Reported
Rezdiffra net sales, first-quarter 2026 Source	$311.3 million
Rezdiffra patients on therapy, March 31, 2026 Source	more than 42,250
R&D expenses, first-quarter 2026 Source	$108.7 million
ARO-PNPLA3 Phase 1 liver fat reduction Source	up to 46% at 12 weeks
Rezdiffra patent protection Source	into 2045

Earlier plans management reported on

Not stated: Management reiterated its earlier robust growth expectation for Rezdiffra in 2026 without a stated status. Source
On track: Management said both the MGL-2086 Phase 1 start in 2Q26 and the drug-drug interaction study in 4Q26 are on track. 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 First-Quarter 2026 Financial Results and Provides Corporate Updates

First-quarter 2026 Rezdiffra® (resmetirom) net sales of $311.3 million, representing year-over-year growth of 127%
As of March 31, 2026, more than 42,250 patients on Rezdiffra, up 2.5x from 1Q25, reflecting continued strong physician adoption and high patient demand
Advances pipeline with global licensing agreement for a clinical-stage siRNA asset targeting a mutation in the PNPLA3 gene, a genetically validated driver of MASH
MGL-2086 (oral GLP-1) Phase 1 trial on track to initiate in 2Q26; ervogastat/resmetirom drug-drug interaction study on track to initiate in 4Q26
Reports cash, cash equivalents, restricted cash and marketable securities of $817.9 million as of March 31, 2026
Company to host conference call today, May 6, 2026, at 8 a.m. EDT

CONSHOHOCKEN, Pa., May 6, 2026 - Madrigal Pharmaceuticals, Inc. (Nasdaq: MDGL), a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), today reports first-quarter 2026 financial results and provides corporate updates.

Bill Sibold, Chief Executive Officer of Madrigal, stated: “2026 is off to a terrific start. Rezdiffra has achieved blockbuster status on a trailing-12-month net sales basis, reflecting broad physician adoption and high patient demand. The market dynamics continue to be very favorable for 2026 and for long-term growth due to a high unmet need in a rapidly growing market that has expanded nearly 50 percent to approximately 460,000 patients in the span of only two years. We’re continuing to steadily add patients, reinforcing our confidence in our robust growth expectations for Rezdiffra in 2026.”

Sibold continued: “We also strengthened our pipeline with a clinical stage siRNA asset targeting a mutation in the PNPLA3 gene that predisposes a significant portion of people with MASH to advanced liver fibrosis, including progression to cirrhosis. This new asset advances our strategy to develop next-generation combination therapies across the spectrum of disease. With our strong cash position and intellectual property protection for Rezdiffra expected into 2045, we are well-positioned to maintain our leadership in MASH, supported by the differentiated clinical profile of Rezdiffra as the only approved liver-directed therapy for this disease, our growing commercial success and an expanding, industry-leading MASH pipeline.”

First Quarter 2026 and Recent Corporate Updates

Madrigal adds clinical-stage siRNA asset targeting PNPLA3 mutation
On May 5, Madrigal announced a licensing agreement with Arrowhead Pharmaceuticals, Inc. for global rights to ARO-PNPLA3, a clinical stage GalNAc-conjugated small interfering RNA (siRNA) asset designed to reduce expression of PNPLA3, a genetically validated driver of MASH.
ARO-PNPLA3 targets MASH patients who are homozygous for a mutation in the PNPLA3 gene, which is highly prevalent among Hispanic patients and represents approximately 30% of patients with moderate to advanced fibrosis (consistent with stages F2 and F3).
Data from a Phase 1 trial of ARO-PNPLA3 demonstrated up to a 46% reduction in liver fat (as measured by MRI-PDFF) at 12 weeks following a single dose at the highest dose level tested in PNPLA3 I148M homozygous patients.
Expanded pipeline with global rights to six pre-clinical siRNA programs
In February 2026, Madrigal expanded its MASH pipeline with six innovative siRNA programs, providing the potential for a genetically targeted approach, combined with the broad efficacy of Rezdiffra, to create the next generation of MASH therapies.
Preclinical development is underway.
Strong scientific presence at the upcoming EASL Congress
Madrigal will present 8 abstracts at the European Association for the Study of Liver (EASL) Congress, taking place May 27-30, 2026, in Barcelona, Spain.
Accepted abstracts include a poster featuring a secondary analysis from Madrigal’s MAESTRO-NASH/NAFLD1 trials showing that Rezdiffra reduced Lp(a) and LDL-C in patients with MASH, supporting its potential to reduce cardiovascular risk independent of baseline statin use, as well as two posters sharing real-world efficacy data for patients on Rezdiffra for up to one year.

First-Quarter 2026 Financial Results

Total Revenues: First-quarter 2026 net revenues were $311.3 million, an increase of 127% compared to $137.3 million in the comparable prior year period.
Operating Expenses: First-quarter 2026 operating expenses were $404.1 million, inclusive of $34.0 million in non-cash stock-based compensation expense, compared to operating expenses of $216.6 million, inclusive of $20.9 million in non-cash stock-based compensation expense for the prior year period. First-quarter operating expenses also included one-time, upfront business development expenses of $54.3 million for strategic pipeline expansion.
Cost of Sales: First-quarter 2026 cost of sales was $26.8 million compared to $4.5 million in the comparable prior year period. This was inclusive of non-cash stock-based compensation expense.
R&D Expenses: First-quarter 2026 R&D expenses were $108.7 million compared to $44.2 million in the comparable prior year period, both inclusive of non-cash stock-based compensation expense. The increase in R&D expenses was primarily due to one-time, upfront business development expenses of $54.3 million.
SG&A Expenses: First-quarter 2026 SG&A expenses were $268.5 million compared to $167.9 million in the comparable prior year period, both inclusive of non-cash stock-based compensation expense. The increase 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, as well as marketing efforts, including a direct -to-consumer (DTC) campaign.
Net Loss: First-quarter 2026 net loss was $94.4 million or $3.25 per share (basic and diluted) compared to a net loss of $73.2 million or $2.61 per share (basic and diluted) in the comparable prior year period. Net loss in 2026 was inclusive of one-time, upfront business development expenses of $54.3 million, or $1.87 per share.
Cash, Cash Equivalents, Restricted Cash and Marketable Securities: As of Mar. 31, 2026, Madrigal had cash, cash equivalents, restricted cash, and marketable securities of $817.9 million, compared to $988.6 million as of Dec. 31, 2025.

Conference Call and Webcast

At 8 a.m. EDT today, May 6, 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 sales in 2026, expectations regarding patent protection for Rezdiffra, Madrigal’s clinical development plans and timelines for its pipeline, Madrigal’s leadership position in the MASH sector, the potential size of the MASH market, the potential benefit of Rezdiffra in patients with compensated MASH cirrhosis and the potential benefit of siRNAs in the treatment of MASH. Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to: the assumptions underlying the forward-looking statements; our ability to successfully commercialize Rezdiffra in the U.S. and Europe; risks related to obtaining and maintaining regulatory approvals, including, but not limited to, potential regulatory delays or rejections; our history of operating losses and the possibility that we may never achieve or maintain profitability; risks associated with meeting the objectives of our clinical trials, including, but not limited to our ability to achieve enrollment objectives concerning patient numbers (including an adequate safety database), outcomes objectives and/or timing objectives for our 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; our ability to service indebtedness and otherwise comply with debt covenants; outcomes or trends from competitors; future topline data timing or results; our ability to prevent and/or mitigate cyber-attacks; our ability to protect our 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 our business and our 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. 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 (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 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