MDGL

EX-99.1

2 exhibit991-93026earningspr.htm

EX-99.1

Document

Exhibit 99.1

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

EX-99.1

2 exhibit991-63026earningspr.htm

EX-99.1

Document

Exhibit 99.1

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

•Second-quarter 2026 Rezdiffra® (resmetirom) net sales of $364.3 million, representing year-over-year growth of 71%

•As of June 30, 2026, more than 49,000 patients on Rezdiffra, more than doubling from 2Q25 reflecting continued strong physician adoption and high patient demand

•Strengthened IP portfolio with 3 new resmetirom patents, including F4c patent

•MGL-2086 (oral GLP-1) Phase 1 trial dosing initiated in June 2026 as part of Rezdiffra/ MGL-2086 combination program in MASH

•Reports cash, cash equivalents, restricted cash and marketable securities of $838.9 million as of June 30, 2026

•Company to host conference call today, July 30, 2026, at 8 a.m. EDT

CONSHOHOCKEN, Pa., July 30, 2026 – Madrigal Pharmaceuticals, Inc. (Nasdaq: MDGL), a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), today reports second-quarter 2026 financial results and provides corporate updates.

Bill Sibold, Chief Executive Officer of Madrigal, stated: “Madrigal delivered another outstanding quarter driven by exceptional execution and market fundamentals. We have the foundational MASH medicine, Rezdiffra, in a rapidly expanding, high unmet need market that has remarkable potential for growth, given today’s low diagnosis and treatment rates. Earlier this month, we surpassed 50,000 active patients on Rezdiffra, an important milestone which reflects the strength of our launch and the significant need for an effective MASH treatment. Rezdiffra has already achieved nearly $1.3 billion in trailing-12-month net sales, and we’re still at the beginning of one of the largest opportunities in biotechnology.”

Sibold continued: “Our strategy is straightforward: maximize the long-term value of Rezdiffra while building the industry-leading MASH pipeline. This quarter we strengthened Rezdiffra's intellectual property portfolio, advanced MGL-2086 into the clinic, and continued to generate compelling clinical and real-world evidence that reinforces Rezdiffra as the foundational therapy in MASH that demonstrates efficacy across all patient subgroups. We're investing from a position of strength and building the next generation of MASH therapies designed to extend our leadership for the long term.”

Second Quarter 2026 and Recent Corporate Updates

•Strengthened IP portfolio with 3 new resmetirom patents

◦F2-F3: The U.S. Patent and Trademark Office (USPTO) issued two new patents directed to Rezdiffra’s FDA approved label. Both patents have been listed in the FDA Orange Book.

▪U.S. Patent No. 12,667,575, directed to administering a weight-threshold step-down 60mg or 80mg resmetirom dose for patients with F2-F3 MASH also using a moderate CYP2C8 inhibitor. This patent is expected to provide protection into 2045.

▪U.S. Patent No. 12,661,359, directed to the administration of rosuvastatin and resmetirom and limits the daily dose of rosuvastatin to a maximum of 20mg per day to reduce or eliminate dose-related side effects. This patent is expected to provide protection into 2042.

◦F4c: The USPTO also issued a new patent, U.S. Patent No. 12,661,361, directed to a method of administering resmetirom to treat well-compensated cirrhosis (F4c). This patent is expected to provide protection into 2042.

•Advanced MGL-2086 (oral GLP-1) into Phase 1 to support Madrigal’s strategy to develop innovative combination treatments for MASH anchored by Rezdiffra

◦Combining Rezdiffra with MGL-2086, an oral GLP-1, offers potential for a best-in-disease MASH treatment in a once daily, well-tolerated pill.

◦The first step of the development program has been initiated: the first healthy volunteers have been dosed in a Phase 1 single ascending dose (SAD) trial of MGL-2086 to assess safety and dose response.

◦Data from Phase 3 MAESTRO-NASH trial demonstrated that even modest weight loss (≥5%) has the potential to enhance Rezdiffra’s antifibrotic efficacy, providing the scientific rationale for combination therapy development.

◦MGL-2086 is an oral small molecule glucagon-like peptide-1 (GLP-1) receptor agonist and an orforglipron derivative.

•Data presentations at EASL Congress in May reinforced Rezdiffra as the foundational MASH therapy

◦Real world data: Over a mean follow-up period of approximately nine months, real-world data demonstrated that nearly 50% of patients treated with Rezdiffra achieved at least a 25% improvement in liver stiffness, a key measure of treatment response.

◦F4c: A MASH-specific risk stratification model (ANTICIPATE-NASH) that estimates clinically significant portal hypertension (CSPH) risk and likelihood of liver-related events was applied to MAESTRO-NAFLD-1 OLE F4c results. The proportion of patients classified as higher risk for CSPH decreased from 75% at baseline to 54.5% at Year 2.

◦C

SEC.gov | Request Rate Threshold Exceeded

U.S. Securities and Exchange Commission

You’ve Exceeded the SEC’s Traffic Limit

Your request rate has exceeded the SEC’s maximum allowable requests per second. Your access to SEC.gov will be limited for 10 minutes.

Current guidelines limit each user to a total of no more than 10 requests per second, regardless of the number of machines used to submit requests. To ensure that SEC.gov remains available to all users, we reserve the right to block IP addresses that submit excessive requests.

The block will be lifted automatically by waiting 10 minutes. Continuing to exceed the SEC’s maximum allowable request rate during the time-out period will extend the duration of the time-out period. To ensure fair access for all users, please reduce the rate of your requests and visit SEC.gov again after the 10 minute time-out period has passed.

For best practices on efficiently downloading information from SEC.gov, including the latest EDGAR filings, visit sec.gov/developer. You can also sign up for email updates on the SEC open data program, including best practices that make it more efficient to download data, and SEC.gov enhancements that may impact scripted downloading processes. For more information, contact opendata@sec.gov.

For more information, please see the SEC’s Web Site Privacy and Security Policy. Thank you for your interest in the U.S. Securities and Exchange Commission.

Reference ID: 0.e618d017.1784726169.7ea52a9

More Information

Internet Security Policy

By using this site, you are agreeing to security monitoring and auditing. For security purposes, and to ensure that the public service remains available to users, this government computer system employs programs to monitor network traffic to identify unauthorized attempts to upload or change information or to otherwise cause damage, including attempts to deny service to users.

Unauthorized attempts to upload information and/or change information on any portion of this site are strictly prohibited and are subject to prosecution under the Computer Fraud and Abuse Act of 1986 and the National Information Infrastructure Protection Act of 1996 (see Title 18 U.S.C. §§ 1001 and 1030).

To ensure our website performs well for all users, the SEC monitors the frequency of requests for SEC.gov content to ensure automated searches do not impact the ability of others to access SEC.gov content. We reserve the right to block IP addresses that submit excessive requests. Current guidelines limit users to a total of no more than 10 requests per second, regardless of the number of machines used to submit requests.

If a user or application submits more than 10 requests per second, further requests from the IP address(es) may be limited for a brief period. Once the rate of requests has dropped below the threshold for 10 minutes, the user may resume accessing content on SEC.gov. This SEC practice is designed to limit excessive automated searches on SEC.gov and is not intended or expected to impact individuals browsing the SEC.gov website.

Note that this policy may change as the SEC manages SEC.gov to ensure that the website performs efficiently and remains available to all users.

Note: We do not offer technical support for developing or debugging scripted downloading processes.