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Madrigal Pharmaceuticals Reports Fourth-Quarter and Full-Year 2024 Financial Results and Announces New Two-Year Data Demonstrating Potential Benefit of Rezdiffra (resmetirom) in Patients with Compensated MASH Cirrhosis F

Key Takeaway: Madrigal Pharmaceuticals reported its fourth-quarter and full-year 2024 financial results, highlighting the success of its FDA-approved drug, Rezdiffra. The company presented two-year data from its Phase 3 MAESTRO-NAFLD-1 trial, indicating ongoing benefits in improving MASH fibrosis markers in patients with compensated MASH cirrhosis. The CEO expressed optimism about Madrigal's position in the MASH community and future performance. The approval of Rezdiffra offers hope for patients in a market with currently no approved therapies for this high-risk condition.

Market Sentiment Analysis

POSITIVE FACTORS

  • Madrigal secured FDA approval for Rezdiffra, the first medicine for MASH.
  • The two-year data demonstrates continued improvement in MASH fibrosis markers.
  • Rezdiffra shows potential to be the first effective treatment for F2 to F4c MASH.
  • The successful U.S. launch has energized the MASH community.

Full Press Release Details

Madrigal Pharmaceuticals Reports Fourth-Quarter and Full-Year 2024 Financial Results and Announces New Two-Year Data Demonstrating Potential Benefit of Rezdiffra (resmetirom) in Patients with Compensated MASH Cirrhosis
CONSHOHOCKEN, Pa., Feb. 26, 2025 Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a biopharmaceutical company focused on
delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), today reports fourth-quarter and year-end 2024 financial results and reviews business highlights.
Bill Sibold, Chief Executive Officer of Madrigal, stated, Looking back on 2024, I m incredibly proud of what we accomplished. We secured FDA
approval for Rezdiffra, the first medicine approved for MASH, in March; executed a first-in-disease launch with remarkable results; and are well positioned for strong
performance again in 2025 and beyond.
Sibold continued, The U.S. launch of Rezdiffra has energized the MASH community, and we re
positioned to extend our leadership. Today, we re sharing new two-year analyses from an active-treatment open-label extension arm of our Phase 3 MAESTRO-NAFLD-1
trial that demonstrate Rezdiffra continues to improve key markers of MASH fibrosis out to two years in patients with compensated MASH cirrhosis (F4c). These results add to the growing body of evidence supporting Rezdiffra s potential benefit in
this high-risk patient population, for which there is no approved therapy. A positive read out in our fully enrolled Phase 3 MAESTRO-NASH OUTCOMES trial could make Rezdiffra the first and only treatment for F2 to F4c MASH, and the only therapy with
outcomes data this decade.
New Two-Year Data from the Active-Treatment Open-Label Compensated MASH
Cirrhosis Arm of the Rezdiffra Phase 3 MAESTRO-NAFLD-1 Trial
Fourth-Quarter and Full-Year 2024 Financial Results
Conference Call and Webcast
At 8 a.m. EST today, February 26, 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.
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.
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 10-17 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.
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
Before you take Rezdiffra, tell your healthcare provider about all of your medical conditions, including
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.
full Prescribing Information, including Patient Information, for Rezdiffra.
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- 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,
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 launch of Rezdiffra and its expected use for treating MASH with moderate to advanced fibrosis, 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 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 of obtaining and maintaining regulatory approvals, including, but not limited to, potential
regulatory delays or rejections; the challenges with the commercial launch of a new product, particularly for a company that does not have commercial experience; 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; enrollment and trial conclusion uncertainties; 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, 2023, filed with the SEC on
February 28, 2024, and Part II, Item 1A of its Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, filed with the SEC on October 31, 2024, 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.
Tina Ventura, IR@madrigalpharma.com
Christopher Frates, media@madrigalpharma.com
Madrigal Pharmaceuticals, Inc.
Condensed Consolidated Statement of Operations
(in thousands, except share and per share amounts)
Three Months Ended December 31, Twelve Months Ended December 31,
2024 2023 2024 2023
Revenues:
Product revenue, net $ 103,320 $ $ 180,133 $
Operating expenses:
Cost of sales 3,445 6,233
Research and development 25,648 70,640 236,718 272,350
Selling, general and administrative 141,224 46,536 435,057 108,146
Total operating expenses 170,317 117,176 678,008 380,496
Loss from operations (66,997 ) (117,176 ) (497,875 ) (380,496 )
Interest income 11,079 8,953 46,654 19,578
Interest expense (3,498 ) (3,971 ) (14,671 ) (12,712 )
Net loss $ (59,416 ) $ (112,194 ) $ (465,892 ) $ (373,630 )
Basic and diluted net loss per common share $ (2.71 ) $ (5.68 ) $ (21.90 ) $ (19.99 )
Basic and diluted weighted average number of common shares outstanding 21,929,425 19,760,842 21,272,962 18,687,774
Condensed Consolidated Balance Sheets
December 31,
2024 2023
Cash, cash equivalents, restricted cash and marketable securities $ 931,251 $ 634,131
Trade receivables, net 53,822
Other current assets 47,854 3,150
Other non-current assets 9,320 3,266
Total assets $ 1,042,247 $ 640,547
Liabilities and Equity
Current liabilities $ 169,277 $ 118,548
Long-term liabilities 118,587 116,666
Stockholders equity 754,383 405,333
Total liabilities and stockholders equity $ 1,042,247 $ 640,547

Frequently Asked Questions

What is Rezdiffra used to treat?

Rezdiffra is prescribed for adults with metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver scarring.

What are common side effects of Rezdiffra?

Common side effects include diarrhea, nausea, abdominal pain, dizziness, and vomiting.

What recent data was reported for Rezdiffra?

New two-year analyses from the Phase 3 MAESTRO-NAFLD-1 trial show continued improvement in MASH fibrosis.

Who is target patient for Rezdiffra?

Rezdiffra aims to treat approximately 315,000 patients with moderate to advanced MASH fibrosis.

When did Rezdiffra receive FDA approval?

Rezdiffra received FDA approval in March 2024, marking it the first treatment for MASH.

Last updated: Feb 26, 2025