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Madrigal Pharmaceuticals Reports First-Quarter 2024 Financial Results and Provides Corporate Updates On

Key Takeaway: Madrigal Pharmaceuticals reported its first-quarter 2024 financial results and announced the launch of Rezdiffra, an FDA-approved therapy for nonalcoholic steatohepatitis (NASH). The CEO highlighted the drug's potential as a foundational treatment and expressed optimism regarding initial reactions from the medical community. The company aims to target around 315,000 patients with moderate to advanced liver fibrosis caused by NASH. Despite the promising launch, Madrigal faces challenges associated with securing regulatory approvals and executing its commercial strategy.

Market Sentiment Analysis

POSITIVE FACTORS

  • Madrigal Pharmaceuticals has launched Rezdiffra, the first approved therapy for NASH.
  • The CEO expresses strong confidence in Rezdiffra's market position and efficacy.
  • There is significant enthusiasm from healthcare stakeholders regarding the new therapy.

CONCERNS & RISKS

  • The company faces challenges associated with the commercial launch of a new product.
  • There may be risks related to obtaining and maintaining regulatory approvals.

Full Press Release Details

Madrigal Pharmaceuticals Reports First-Quarter 2024 Financial Results and Provides Corporate Updates
CONSHOHOCKEN, Pa., May 7, 2024 Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a biopharmaceutical company focused on
delivering novel therapeutics for nonalcoholic steatohepatitis (NASH), today reports first-quarter 2024 financial results and provides corporate updates.
Bill Sibold, Chief Executive Officer of Madrigal, stated, Madrigal is the first company to deliver an approved therapy for patients with NASH, which we
believe will give us a strong competitive advantage for many years to come. As a once-daily, well-tolerated, liver-directed, oral medicine that has demonstrated unprecedented efficacy in a pivotal Phase 3 trial, Rezdiffra is well positioned to
become the foundational therapy for this serious disease. He continued, We are focused on executing this first-in-disease launch, where our expert team is
partnering with the NASH community to establish treatment pathways for patients, laying the groundwork for our long-term leadership. I m highly encouraged by the enthusiasm we re seeing for Rezdiffra across our key stakeholders in these
early weeks of launch.
Rezdiffra Launch Update
On March 14, 2024, the Company received U.S. Food and Drug Administration (FDA) approval for Rezdiffra for the treatment of patients with noncirrhotic
NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). Rezdiffra is a once-daily, oral, liver-directed, THR- agonist designed to target key underlying causes
Quarter and Recent Corporate Updates
First-Quarter 2024 Financial Results
Conference Call and Webcast
At 8 a.m. EDT today, May 7, 2024, the Company 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.
Nonalcoholic steatohepatitis (NASH) is a more
advanced form of nonalcoholic fatty liver disease (NAFLD). NASH is a leading cause of liver-related mortality and an increasing burden on healthcare systems globally. Additionally, patients with NASH, especially those with more
advanced metabolic risk factors (hypertension, concomitant type 2 diabetes), are at increased risk for adverse cardiovascular events and increased morbidity and mortality.
Once patients progress to NASH with moderate to advanced liver fibrosis (consistent with stages F2
to F3 fibrosis), the risk of adverse liver outcomes increases dramatically. NASH is rapidly becoming the leading cause of liver transplantation in the U.S.
Madrigal estimates that approximately 1.5 million patients have been diagnosed with NASH in the U.S., of which approximately 525,000
have NASH with moderate to advanced liver fibrosis. Madrigal plans to focus on approximately 315,000 diagnosed patients with NASH with moderate to advanced liver fibrosis under the care of the liver specialist physicians during
the launch of Rezdiffra.
NASH is also known as metabolic dysfunction associated steatohepatitis (MASH). In 2023, global liver disease medical
societies and patient groups came together to rename the disease, with the goal of establishing an affirmative, non-stigmatizing name and diagnosis. Nonalcoholic fatty liver disease (NAFLD) was renamed
metabolic dysfunction-associated steatotic liver disease (MASLD); NASH was renamed MASH; and an overarching term, steatotic liver disease (SLD), was established to capture multiple types of liver diseases associated with fat buildup in the
liver. In addition to liver disease, patients with MASH have at least one related comorbid condition (e.g., obesity, hypertension, dyslipidemia, or type 2 diabetes).
About Madrigal Pharmaceuticals
Pharmaceuticals, Inc. (Nasdaq: MDGL) is a biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), 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 NASH. For more information, visit www.madrigalpharma.com.
Forward Looking Statements
includes forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, that are based on Madrigal s beliefs and assumptions and on information currently available to
it but are subject to factors beyond its control. Forward-looking statements reflect management s current knowledge, assumptions, judgment and expectations regarding future performance or events. Forward-looking statements include all
statements that are not historical facts; statements referenced by forward-looking statement identifiers; and statements regarding: Rezdiffra (resmetirom) and its expected use for treating NASH with moderate to advanced fibrosis; the
initiation of the commercial launch of Rezdiffra, including statements regarding commercial insurance and the anticipated time to fill prescriptions; estimates of patients diagnosed with NASH and market opportunities; the relationship
between NASH progression and adverse patient outcomes; the estimated clinical burden of uncontrolled NASH; analyses for patients with NASH with moderate to advanced fibrosis concerning potential progression to cirrhosis,
decompensated cirrhosis, liver transplant or death; cardiovascular risks, comorbidities and outcomes; health economics assessments or projections; indicating Rezdiffra has been shown to improve the fibrosis that is associated with progression to
cirrhosis and its complications and resolve the underlying
inflammation that drives the disease; projections or objectives for obtaining full approval for Rezdiffra (resmetirom), including those concerning potential clinical benefit to support potential
full approval; regarding post-approval requirements and commitments; reduced risk of progression to cirrhosis, liver failure, need for liver transplant and premature mortality; treatment paradigm; improved liver enzymes, fibrosis biomarkers and
imaging tests; the potential efficacy and safety of Rezdiffra (resmetirom) for noncirrhotic NASH patients and cirrhotic NASH patients; possible or assumed future results of operations and expenses, business strategies and plans
(including ex-US. Launch/partnering plans); research and development activities, the timing and results associated with the future development of Rezdiffra (resmetirom), the timing and completion of projected
future clinical milestone events, including enrollment, additional studies, the potential to support an additional indication for Rezdiffra (resmetirom) in patients with well-compensated NASH cirrhosis; optimal dosing levels for Rezdiffra
(resmetirom); potential NASH or NAFLD and potential patient benefits with Rezdiffra (resmetirom), including future NASH resolution, safety, fibrosis treatment, cardiovascular effects, lipid treatment, and/or biomarker effects
with Rezdiffra (resmetirom); and strategies, objectives and commercial opportunities, including potential prospects or results. Forward-looking statements can be identified by terms such as accelerate, achieve,
allow, anticipates, appear, be, believes, can, confidence, continue, could, demonstrates, design,
estimates, expectation, expects, forecasts, future, goal, help, hopeful, inform, inform, intended, intends,
may, might, on track, planned, planning, plans, positions, potential, powers, predicts, predictive,
projects, seeks, should, will, will achieve, will be, would or similar expressions and the negatives of those terms.
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; risks associated with meeting the objectives of Madrigal s clinical studies, 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 studies; 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 our product; the potential inability to raise sufficient capital to fund ongoing operations as currently planned or to obtain financings on terms similar to
those arranged in the past; the ability to service indebtedness and otherwise comply with debt covenants; outcomes or trends from competitive studies; future topline data timing or results; our ability to prevent and/or mitigate cyber-attacks; the
timing and outcomes of clinical studies of Rezdiffra (resmetirom); the uncertainties inherent in clinical testing; and uncertainties concerning analyses or assessments outside of a controlled clinical trial. 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
of unanticipated events. Please refer to Madrigal s submissions filed with the U.S. Securities and Exchange Commission, or 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 March 31, 2024, filed with the SEC on May 7, 2024, and as updated from time to time by Madrigal s other filings with the SEC.
Tina Ventura, Madrigal Pharmaceuticals,
Christopher Frates, Madrigal Pharmaceuticals, Inc., media@madrigalpharma.com
Madrigal Pharmaceuticals, Inc.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share amounts)
Three Months Ended
March 31,
2024 2023
Revenues:
Total revenues $ $
Operating expenses:
Research and development 71,237 62,154
Selling, general and administrative 80,800 16,182
Total operating expenses 152,037 78,336
Loss from operations (152,037 ) (78,336 )
Interest income, net 8,334 3,776
Interest expense (3,838 ) (2,336 )
Net loss $ (147,541 ) $ (76,896 )
Basic and diluted net loss per common share $ (7.38 ) $ (4.23 )
Basic and diluted weighted average number of common shares outstanding 20,001,569 18,187,924
Madrigal Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
March 31, December 31,
2024 2023
Assets
Cash, cash equivalents and marketable securities $ 1,059,063 $ 634,131
Other current assets 14,889 3,150
Other non-current assets 8,328 3,266
Total assets $ 1,082,280 $ 640,547
Liabilities and Equity
Current liabilities $ 114,341 $ 118,548
Long-term liabilities 117,180 116,666
Stockholders equity 850,759 405,333
Total liabilities and stockholders equity $ 1,082,280 $ 640,547

Frequently Asked Questions

What is Rezdiffra used for?

Rezdiffra is approved for treating noncirrhotic NASH with moderate to advanced liver fibrosis.

When was Rezdiffra approved by the FDA?

Rezdiffra received FDA approval on March 14, 2024.

How many U.S. patients are estimated to have NASH?

Approximately 1.5 million patients have been diagnosed with NASH in the U.S.

What company develops Rezdiffra?

Rezdiffra is developed by Madrigal Pharmaceuticals, Inc.

What is the administration frequency of Rezdiffra?

Rezdiffra is taken once daily as an oral medication.

Last updated: May 7, 2024