Full Press Release Details
Madrigal Pharmaceuticals Reports Third-Quarter 2024 Financial Results and Provides Corporate Updates
CONSHOHOCKEN, Pa., Oct. 31, 2024 Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a biopharmaceutical company focused on
delivering novel therapeutics for nonalcoholic steatohepatitis (NASH)/metabolic dysfunction-associated steatohepatitis (MASH), today reports third-quarter 2024 financial results and provides corporate updates.
Bill Sibold, Chief Executive Officer of Madrigal, stated, Our U.S. launch of Rezdiffra is progressing exceptionally well driven by the outstanding
execution of our team. Growing adoption by prescribers, broader payer coverage and an increasing number of patients on therapy each contributed to the strong performance. This early success highlights the critical need for effective treatments for
moderate to advanced NASH/MASH, which is expected to become the leading cause of liver transplants in the U.S.
Sibold continued, We ve
also advanced our pipeline, completing enrollment in our clinical outcomes study for patients with compensated NASH/MASH cirrhosis. This milestone is key, as positive results could lead to full approval and a broader indication for Rezdiffra.
Third Quarter and Recent Corporate Updates
Third-Quarter 2024 Financial Results
Conference Call and Webcast
At 8 a.m. EDT today,
October 31, 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 expected to become the leading cause of liver transplants 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 is focusing 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 focused on delivering 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
This press release 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; potential future growth of Rezdiffra sales; projections or objectives for obtaining approval from EMA for Rezdiffra (resmetirom) and expected commercialization
of Rezdiffra (resmetirom) in Europe; expectations regarding payer coverage; the potential impact of positive results from the MAESTRO-NASH OUTCOMES trial expected presence at the AASLD 2024 Liver Meeting; the U.S. opportunity for Rezdiffra in
patients with NASH with moderate to advanced liver fibrosis; the competitive landscape and market dynamics; estimates of patients diagnosed with NASH and market opportunities; 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 , future 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; 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 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 Rezdiffra; the potential
inability to raise sufficient capital to fund ongoing operations as currently planned or to obtain financing on acceptable terms; 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; 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, 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 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.
Christopher Frates, media@madrigalpharma.com
Madrigal Pharmaceuticals, Inc.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share amounts)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Revenues: | ||||||||||||||||
| Product revenue, net | $ | 62,175 | $ | $ | 76,813 | $ | ||||||||||
| Operating expenses: | ||||||||||||||||
| Cost of sales | 2,152 | 2,788 | ||||||||||||||
| Research and development | 68,742 | 70,951 | 211,070 | 201,710 | ||||||||||||
| Selling, general and administrative | 107,585 | 27,583 | 293,834 | 61,610 | ||||||||||||
| Total operating expenses | 178,479 | 98,534 | 507,692 | 263,320 | ||||||||||||
| Loss from operations | (116,304 | ) | (98,534 | ) | (430,879 | ) | (263,320 | ) | ||||||||
| Interest income, net | 13,019 | 3,298 | 35,575 | 10,625 | ||||||||||||
| Interest expense | (3,679 | ) | (3,504 | ) | (11,172 | ) | (8,741 | ) | ||||||||
| Net loss | $ | (106,964 | ) | $ | (98,740 | ) | $ | (406,476 | ) | $ | (261,436 | ) | ||||
| Basic and diluted net loss per common share | $ | (4.92 | ) | $ | (5.34 | ) | $ | (19.31 | ) | $ | (14.27 | ) | ||||
| Basic and diluted weighted average number of common shares outstanding | 21,745,929 | 18,476,414 | 21,052,544 | 18,326,154 |
Madrigal Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
| September 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| Assets | ||||||||
| Cash, cash equivalents, restricted cash, and marketable securities | $ | 1,003,627 | $ | 634,131 | ||||
| Trade receivables, net | 30,463 | |||||||
| Other current assets | 29,576 | 3,150 | ||||||
| Other non-current assets | 9,599 | 3,266 | ||||||
| Total assets | $ | 1,073,265 | $ | 640,547 | ||||
| Liabilities and Equity | ||||||||
| Current liabilities | $ | 177,847 | $ | 118,548 | ||||
| Long-term liabilities | 118,263 | 116,666 | ||||||
| Stockholders equity | 777,155 | 405,333 | ||||||
| Total liabilities and stockholders equity | $ | 1,073,265 | $ | 640,547 |