CONSHOHOCKEN, Pa., Aug. 07, 2024 (GLOBE NEWSWIRE) — Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a biopharmaceutical company focused on delivering novel therapeutics for nonalcoholic steatohepatitis (NASH)/metabolic dysfunction-associated steatohepatitis (MASH), today reports second-quarter 2024 financial results and provides corporate updates.
Bill Sibold, Chief Executive Officer of Madrigal, stated, “We’re off to a strong start with our U.S. launch of Rezdiffra and are encouraged by the high enthusiasm and early demand from physicians and patients, as well as the favorable coverage from payers. Our efforts to help healthcare practices build patient care pathways are progressing well, setting the stage for future growth. Given the strong start in the U.S., we aim to extend Madrigal’s global leadership in NASH by directly commercializing Rezdiffra in Europe next year upon regulatory approval.”
Mr. Sibold continued, “The urgent unmet need in NASH, which is the leading cause of liver transplant among women in the U.S., is driving the strong reception to Rezdiffra as the first and only approved therapy for NASH. Data presented at the EASL Congress demonstrating 91% efficacy in halting or improving liver stiffness, a key noninvasive measure of fibrosis, at three years reinforce the Rezdiffra efficacy profile; and the new EASL guidelines position Rezdiffra as the foundational NASH therapy.”
Second Quarter and Recent Corporate Updates
Second-Quarter 2024 Financial Results
Conference Call and Webcast
At 8 a.m. EDT today, August 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.
About NASH
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
Madrigal 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-β 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; future growth of Rezdiffra sales; projections or objectives for obtaining approval from EMA for Rezdiffra (resmetirom) and expected commercialization of Rezdiffra (resmetirom) in Europe; the final number of patients who randomize in the MAESTRO-NASH trial, the estimated study duration for such trial and the anticipated timeframe for topline data from such trial; the U.S. opportunity for Rezdiffra in patients with stage 4 fibrosis (F4)/compensated cirrhosis; 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; 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 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 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.
Investor Contact
Tina Ventura, IR@madrigalpharma.com
Media Contact
Christopher Frates, media@madrigalpharma.com
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Madrigal Pharmaceuticals, Inc. | |||||||||||||
Condensed Consolidated Statements of Operations | |||||||||||||
(in thousands, except share and per share amounts) | |||||||||||||
(unaudited) | |||||||||||||
Three Months Ended | Six Months Ended | ||||||||||||
June 30, | June 30, | ||||||||||||
2024 | 2023 | 2024 | 2023 | ||||||||||
Revenues: | |||||||||||||
Product revenue, net | $ | 14,638 | $ | – | $ | 14,638 | $ | – | |||||
Operating expenses: | |||||||||||||
Cost of sales | 636 | – | 636 | – | |||||||||
Research and development | 71,091 | 68,605 | 142,328 | 130,759 | |||||||||
Selling, general and administrative | 105,448 | 17,845 | 186,249 | 34,027 | |||||||||
Total operating expenses | 177,175 | 86,450 | 329,213 | 164,786 | |||||||||
Loss from operations | (162,537 | ) | (86,450 | ) | (314,575 | ) | (164,786 | ) | |||||
Interest income, net | 14,222 | 3,551 | 22,556 | 7,327 | |||||||||
Interest expense | (3,656 | ) | (2,901 | ) | (7,493 | ) | (5,237 | ) | |||||
Net loss | $ | (151,971 | ) | $ | (85,800 | ) | $ | (299,512 | ) | $ | (162,696 | ) | |
Basic and diluted net loss per common share | $ | (7.10 | ) | $ | (4.69 | ) | $ | (14.47 | ) | $ | (8.91 | ) | |
Basic and diluted weighted average number of common shares outstanding | 21,402,646 | 18,310,952 | 20,702,041 | 18,249,778 | |||||||||
Madrigal Pharmaceuticals, Inc. | |||||||||||||
Condensed Consolidated Balance Sheets | |||||||||||||
(in thousands) | |||||||||||||
(unaudited) | |||||||||||||
June 30, | December 31, | ||||||||||||
2024 | 2023 | ||||||||||||
Assets | |||||||||||||
Cash, cash equivalents, restricted cash, and marketable securities | $ | 1,062,794 | $ | 634,131 | |||||||||
Other current assets | 28,934 | 3,150 | |||||||||||
Other non-current assets | 8,061 | 3,266 | |||||||||||
Total assets | $ | 1,099,789 | $ | 640,547 | |||||||||
Liabilities and Equity | |||||||||||||
Current liabilities | $ | 125,162 | $ | 118,548 | |||||||||
Long-term liabilities | 117,507 | 116,666 | |||||||||||
Stockholders’ equity | 857,120 | 405,333 | |||||||||||
Total liabilities and stockholders’ equity | $ | 1,099,789 | $ | 640,547 | |||||||||
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