CONSHOHOCKEN, Pa., May 01, 2025 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL), a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), today reports first-quarter 2025 financial results and provides corporate updates.
Bill Sibold, Chief Executive Officer of Madrigal, stated, “Since Rezdiffra’s approval last year, we’ve executed an exceptional launch. We introduced the first FDA-approved treatment for MASH, launched with a best-case label, built a strong foundation with healthcare providers and payers, and delivered Rezdiffra to more than 17,000 patients. What’s most gratifying is the positive feedback we’re hearing from healthcare providers – they’re seeing meaningful improvements in the measures that matter most to patients, including liver stiffness, liver fat, liver enzymes, LDL and triglycerides, which are exceeding their expectations.”
Sibold continued, “We’re building on our leadership in MASH, and we believe Rezdiffra is on track to become the foundational therapy across F2 to F4c MASH. Later this month at the EASL Congress, we’ll share new Rezdiffra F4c late-breaking data from our MAESTRO-NAFLD-1 trial that shows its effect on the risk of clinically significant portal hypertension – a major consequence of cirrhosis that’s responsible for its most severe complications. In addition, we’re awaiting a regulatory decision from the European Medicines Agency expected mid-year that, if positive, would make Rezdiffra the first MASH therapy approved for patients in Europe.”
First Quarter 2025 and Recent Corporate Updates
First-Quarter 2025 Financial Results
Conference Call and Webcast
At 8 a.m. EDT today, May 1, 2025, 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), formerly known as nonalcoholic steatohepatitis (NASH), is a serious liver disease that can progress to cirrhosis, liver failure, liver cancer, need for liver transplantation, and premature mortality. MASH is expected to become the leading cause of liver transplantation in the U.S. and is already the leading cause of liver transplantation among women.
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. Those 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.
An estimated 1.5 million patients have been diagnosed with MASH in the U.S., and Madrigal is focused on reaching approximately 315,000 patients with moderate to advanced fibrosis who are under the care of liver specialists. As MASH disease awareness improves and disease prevalence increases, the number of diagnosed patients with MASH with moderate to advanced fibrosis is expected to grow.
About Rezdiffra
What is Rezdiffra?
Rezdiffra is a prescribed medicine used along with diet and exercise to treat adults with nonalcoholic steatohepatitis (NASH) with moderate to advanced liver scarring (fibrosis), but not with cirrhosis of the liver.
It is not known if Rezdiffra is safe and effective in children (under 18 years old).
This indication is approved based on improvement of NASH and liver scarring (fibrosis). There are ongoing studies to confirm the clinical benefit of Rezdiffra.
Before you take Rezdiffra, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What are the possible side effects of Rezdiffra?
Rezdiffra may cause serious side effects, including:
The most common side effects of Rezdiffra include: diarrhea, nausea, itching, stomach (abdominal) pain, vomiting, dizziness, constipation.
These are not all the possible side effects of Rezdiffra. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Madrigal at 1-800-905-0324.
Please see the full Prescribing Information, including Patient Information, for Rezdiffra.
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 is the first and only medication approved by the FDA for the treatment of MASH with moderate to advanced fibrosis (consistent with stages F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (consistent with stage 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 Madrigal’s aspirations to be the leading company in the MASH sector and Rezdiffra’s role as a foundational therapy, the timing and potential impact of results from the MAESTRO-NASH OUTCOMES trial, the potential benefit of Rezdiffra in patients with compensated MASH cirrhosis, the timing for a regulatory decision by the European Commission and the planned launch of Rezdiffra in Europe. Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to: the assumptions underlying the forward-looking statements; 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 Madrigal’s clinical trials, including, but not limited to Madrigal’s 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; market demand for and acceptance of Rezdiffra; the potential inability to raise sufficient capital to fund ongoing operations as currently planned or to obtain financing on acceptable terms; our ability to service indebtedness and otherwise comply with debt covenants; outcomes or trends from competitive trials; future topline data timing or results; our ability to prevent and/or mitigate cyber-attacks; the timing and outcomes of clinical trials of Rezdiffra (resmetirom); 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 I, Item 1A of its Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on February 26, 2025, and Part II, Item 1A of its Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, filed with the SEC on May 1, 2025, and as updated from time to time by Madrigal’s other filings with the SEC.
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
| Madrigal Pharmaceuticals, Inc. | ||||||||
| Condensed Consolidated Statement of Operations | ||||||||
| (in thousands, except share and per share amounts) | ||||||||
| (unaudited) | ||||||||
| Three Months Ended | ||||||||
| March 31, | ||||||||
| 2025 | 2024 | |||||||
| Revenues: | ||||||||
| Product revenue, net | $ | 137,250 | $ | - | ||||
| Operating expenses: | ||||||||
| Cost of sales | 4,513 | - | ||||||
| Research and development | 44,172 | 71,237 | ||||||
| Selling, general and administrative | 167,876 | 80,800 | ||||||
| Total operating expenses | 216,561 | 152,037 | ||||||
| Loss from operations | (79,311 | ) | (152,037 | ) | ||||
| Interest income | 9,370 | 8,334 | ||||||
| Interest expense | (3,297 | ) | (3,838 | ) | ||||
| Net loss | $ | (73,238 | ) | $ | (147,541 | ) | ||
| Basic and diluted net loss per common share | $ | (3.32 | ) | $ | (7.38 | ) | ||
| Basic and diluted weighted average number of common shares outstanding | 22,091,314 | 20,001,569 | ||||||
| Madrigal Pharmaceuticals, Inc. | ||||||||
| Condensed Consolidated Balance Sheets | ||||||||
| (in thousands) | ||||||||
| (unaudited) | ||||||||
| March 31, | December 31, | |||||||
| 2025 | 2024 | |||||||
| Cash, cash equivalents, restricted cash and marketable securities | $ | 848,068 | $ | 931,251 | ||||
| Trade receivables, net | 61,428 | 53,822 | ||||||
| Other current assets | 78,483 | 47,854 | ||||||
| Other non-current assets | 8,650 | 9,320 | ||||||
| Total assets | $ | 996,629 | $ | 1,042,247 | ||||
| Liabilities and Equity | ||||||||
| Current liabilities | $ | 167,237 | $ | 169,277 | ||||
| Long-term liabilities | 118,755 | 118,587 | ||||||
| Stockholders’ equity | 710,637 | 754,383 | ||||||
| Total liabilities and stockholders’ equity | $ | 996,629 | $ | 1,042,247 | ||||