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Madrigal Pharmaceuticals (NASDAQ: MDGL) posts $364M Q2 Rezdiffra sales

(Moderate)
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Madrigal Pharmaceuticals reported second-quarter 2026 Rezdiffra net revenues of $364.3 million, up 71% from $212.8 million a year earlier, with more than 49,000 patients on therapy and nearly $1.3 billion in trailing-12-month net sales.

The company highlighted three new U.S. resmetirom patents expected to protect key uses into 2042–2045 and initiated first-in-human dosing for oral GLP-1 candidate MGL-2086 in a Phase 1 trial supporting combination MASH therapy. Operating expenses rose to $420.6 million, leading to a net loss of $57.9 million, while cash, cash equivalents, restricted cash and marketable securities totaled $838.9 million as of June 30, 2026.

Positive

  • Rezdiffra net revenues grew 71% year over year to $364.3 million in Q2 2026, with nearly $1.3 billion in trailing-12-month net sales and more than 49,000 patients on therapy, indicating rapid commercial uptake in the MASH market.
  • Three new U.S. resmetirom patents were issued, including protection for F2–F3 dosing strategies and F4c treatment, with expected patent lives extending into 2042–2045, strengthening Rezdiffra’s intellectual property position.

Negative

  • Net loss widened to $57.9 million in Q2 2026, or $1.99 per share, as operating expenses increased to $420.6 million despite strong revenue growth from Rezdiffra.

Filing Explained

The filing adds issued, label-linked patent coverage while MGL-2086 remains at an early safety-and-dose-response testing stage.

Form 8-K reports specified material events; here, Madrigal Pharmaceuticals furnished its July 30 press release under Item 2.02. The release is expressly not deemed “filed” under Section 18, so the event is a furnished results and corporate-update disclosure rather than a new ownership mechanic for common holders.

The company says the USPTO issued three resmetirom patents, and that two covering the FDA-approved label were listed in the FDA Orange Book. The patents address dosing with a moderate CYP2C8 inhibitor, rosuvastatin dosing, and treatment of well-compensated cirrhosis; the stated protection periods extend into 2042 or 2045, but those dates are expectations in the release.

MGL-2086 has reached an initiated Phase 1 single-ascending-dose trial: the first healthy volunteers have been dosed to assess safety and dose response. That is a clinical-start milestone, not a completed trial or an efficacy result.

Item 2.02 Results of Operations and Financial Condition Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Q2 2026 net revenues $364.3 million Second-quarter 2026 net revenues, up 71% from $212.8 million in the comparable prior-year period
Rezdiffra patients more than 49,000 Patients on Rezdiffra as of June 30, 2026
Trailing-12-month Rezdiffra net sales nearly $1.3 billion Trailing-12-month net sales achieved by Rezdiffra as referenced by the CEO
Q2 2026 operating expenses $420.6 million Operating expenses for the second quarter of 2026, including $35.4 million of non-cash stock-based compensation
Q2 2026 net loss $57.9 million Net loss for the second quarter of 2026, or $1.99 per share basic and diluted
Cash and securities $838.9 million Cash, cash equivalents, restricted cash and marketable securities as of June 30, 2026
Prior-year net revenues $212.8 million Net revenues in the comparable prior-year quarter used as the base for the 71% growth calculation
metabolic dysfunction-associated steatohepatitis (MASH) medical
"delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a liver disease"
Metabolic dysfunction-associated steatohepatitis (MASH) is a liver condition characterized by inflammation and fat buildup caused by metabolic issues like obesity and insulin resistance. It can lead to liver damage over time, similar to rust gradually weakening metal. Because it is linked to widespread health problems such as diabetes and heart disease, MASH is becoming an important factor in overall health risks and healthcare costs, which can impact economic and investment considerations.
F4c medical
"to treat well-compensated cirrhosis (F4c). This patent is expected"
glucagon-like peptide-1 (GLP-1) medical
"MGL-2086 is an oral small molecule glucagon-like peptide-1 (GLP-1) receptor agonist"
Glucagon-like peptide-1 (GLP-1) is a naturally occurring hormone that helps control blood sugar and reduces appetite by signaling the body to release insulin and slow digestion — like a thermostat that dials down hunger and stabilizes glucose. It matters to investors because medicines that mimic or enhance GLP-1 can treat diabetes and obesity, creating large markets, regulatory milestones, sales prospects and competitive shifts that can materially affect healthcare company value.
MAESTRO-NASH medical
"Data from Phase 3 MAESTRO-NASH trial demonstrated that even modest weight loss"
Orange Book regulatory
"Both patents have been listed in the FDA Orange Book."
A publicly maintained FDA database that lists approved prescription drugs and notes which versions are considered interchangeable with brand-name products, along with key patent and exclusivity dates. Think of it as a product roster plus an expiration calendar: investors use it to see when a drug’s protection ends and generic competition can enter, which can directly affect a company’s sales, future revenue and stock value.
portal hypertension medical
"model (ANTICIPATE-NASH) that estimates clinically significant portal hypertension (CSPH) risk"
An increase in blood pressure in the portal venous system — the veins that carry blood from the intestines to the liver — usually caused by scarring or blockage in the liver that acts like a traffic jam in a pipe. It matters to investors because it drives demand for treatments, diagnostics and procedures, influences clinical trial outcomes and regulatory decisions, and can materially affect healthcare costs and a company’s commercial prospects in liver-related therapies.
Net revenues $364.3 million increase of 71% from $212.8 million in the comparable prior-year period
Net loss $57.9 million compared to a net loss of $42.3 million in the comparable prior-year period

AI-generated analysis. How Rhea-AI works. Not financial advice.

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FAQ

What were Madrigal Pharmaceuticals (MDGL) Q2 2026 revenues?

Madrigal reported Q2 2026 net revenues of $364.3 million, compared with $212.8 million in the prior-year quarter, a 71% increase. Growth was driven by higher U.S. demand for Rezdiffra, the company’s once-daily oral therapy for metabolic dysfunction-associated steatohepatitis (MASH).

Did Madrigal Pharmaceuticals (MDGL) report a profit in Q2 2026?

No. Madrigal recorded a Q2 2026 net loss of $57.9 million, or $1.99 per share, versus a $42.3 million net loss, or $1.50 per share, a year earlier. The loss reflects higher operating expenses, including increased R&D, SG&A and a $25.0 million upfront business development cost.

How many patients are being treated with Rezdiffra as of June 30, 2026?

As of June 30, 2026, more than 49,000 patients were on Rezdiffra. The company noted this figure more than doubled versus the prior-year quarter, and that it surpassed 50,000 active patients earlier in July 2026, underscoring continued physician adoption and patient demand.

What is Madrigal Pharmaceuticals (MDGL) cash position as of June 30, 2026?

Madrigal reported $838.9 million in cash, cash equivalents, restricted cash and marketable securities as of June 30, 2026, compared with $988.6 million at December 31, 2025. This balance supports ongoing commercialization of Rezdiffra and the company’s clinical development programs in MASH.

What pipeline progress did Madrigal (MDGL) announce with its Q2 2026 results?

Madrigal advanced MGL-2086, an oral GLP-1 receptor agonist, into a Phase 1 single ascending dose trial, dosing the first healthy volunteers. The program supports development of Rezdiffra plus MGL-2086 combination therapy to potentially deliver best-in-disease treatment for MASH in a once-daily pill.

What new patent protections did Madrigal (MDGL) secure for Rezdiffra?

Madrigal obtained three new U.S. resmetirom patents, including two covering F2–F3 dosing and statin co-administration and one for treating compensated cirrhosis (F4c). These patents, some Orange Book-listed, are expected to provide protection into 2042–2045, reinforcing Rezdiffra’s exclusivity.
0001157601FALSE00011576012026-07-292026-07-290001157601dei:FormerAddressMember2026-07-292026-07-29

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
____________________
FORM 8-K
____________________
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): July 30, 2026
____________________
MADRIGAL PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
____________________
Delaware001-3327704-3508648
(State or other jurisdiction
of incorporation)
(Commission
File Number)
(IRS Employer
Identification No.)
1001 Conshohocken State Road,
 Suite 2-350
West Conshohocken, Pennsylvania
19428
(Address of principal executive offices)(Zip Code)
(267) 824-2827
Registrant’s telephone number, including area code
Four Tower Bridge
200 Barr Harbor Drive, Suite 200
West Conshohocken, Pennsylvania
19428
(Former name, former address and former fiscal year, if changed since last report)
____________________
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
oWritten communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
oSoliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
oPre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
oPre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading
Symbol(s)
Name of each exchange
on which registered
Common Stock, $0.0001 Par Value Per ShareMDGLThe NASDAQ Stock Market LLC
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company o
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o




Item 2.02 Results of Operations and Financial Condition.

On July 30, 2026, Madrigal Pharmaceuticals, Inc. (the “Company”) issued a press release announcing the Company’s financial results for the quarter ended June 30, 2026. A copy of the press release is furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The information in this Current Report on Form 8-K and the accompanying Exhibit 99.1 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing, unless expressly incorporated by reference in such filing.

Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit
Number
Description
99.1
Press Release Dated July 30, 2026
104Cover Page Interactive Data File (embedded within the Inline XBRL Document)

2


SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
MADRIGAL PHARMACEUTICALS, INC.
By:/s/ Mardi Dier
Name: Mardi Dier
Title: Executive Vice President and Chief Financial Officer
Date: July 30, 2026
3
image1.jpg
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.
Cardiovascular benefits: A secondary analysis from Phase 3 MAESTRO-NASH and MAESTRO-NAFLD-1 trials demonstrated that Rezdiffra improved key histologic MASH endpoints and significantly reduced multiple atherogenic lipoproteins associated with cardiovascular risk, including LDL and Lp(a), regardless of baseline statin use. Findings support the potential for Rezdiffra to address both liver disease and cardiometabolic risk in patients with MASH.
MASH Across America initiative to expand disease awareness
Madrigal has launched MASH Across America, a new disease education campaign that brings MASH to life through a 20-foot tall immersive liver installation depicting the different stages of fibrosis progression. The campaign debuted in Philadelphia on Global Fatty Liver Day and will make stops in additional communities across the United States throughout 2026 and beyond.

Second-Quarter 2026 Financial Results
Total Revenues: Second-quarter 2026 net revenues were $364.3 million, an increase of 71% compared to $212.8 million in the comparable prior year period, driven by increased demand for Rezdiffra in the U.S. in 2026.
Operating Expenses: Second-quarter 2026 operating expenses were $420.6 million, inclusive of $35.4 million in non-cash stock-based compensation expense, compared to operating expenses of $260.0 million, inclusive of $25.2 million in non-cash stock-based compensation expense for the prior year period.
Cost of Sales: Second-quarter 2026 cost of sales was $40.0 million compared to $9.1 million in the comparable prior year period. This was inclusive of non-cash




stock-based compensation expense. The increase in cost of sales was primarily driven by an increase in royalties payable to Roche as a result of an increase in net sales of Rezdiffra in 2026 and a write-down of certain work-in-process inventory.
R&D Expenses: Second-quarter 2026 R&D expenses were $91.2 million compared to $54.1 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 $25.0 million.
SG&A Expenses: Second-quarter 2026 SG&A expenses were $289.4 million compared to $196.9 million in the comparable prior year period, both inclusive of non-cash stock-based compensation expense. The increase in SG&A 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 Loss: Second-quarter 2026 net loss was $57.9 million or $1.99 per share (basic and diluted) compared to a net loss of $42.3 million or $1.50 per share (basic and diluted) in the comparable prior year period. Net loss in the second quarter of 2026 was inclusive of one-time, upfront business development expenses of $25.0 million, or $0.86 per share.
Cash, Cash Equivalents, Restricted Cash and Marketable Securities: As of June 30, 2026, Madrigal had cash, cash equivalents, restricted cash, and marketable securities of $838.9 million, compared to $988.6 million as of Dec. 31, 2025.

Conference Call and Webcast
At 8 a.m. EDT today, July 30, 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
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, expectations regarding patent protection for resmetirom, Madrigal’s clinical development plans and timelines for its pipeline, Madrigal’s leadership position in the MASH sector, the potential benefit of resmetirom in patients with compensated MASH cirrhosis, Rezdiffra’s ability to potentially improve cardiovascular outcomes in patients with MASH and the potential benefit of Madrigal’s pipeline candidates for 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. 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 1, 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.
Investor Contact
Tina Ventura, IR@madrigalpharma.com
Media Contact
Christopher Frates, media@madrigalpharma.com




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Filing Exhibits & Attachments

5 documents