On March 14, 2024, received U.S. FDA approval of Rezdiffra™ (resmetirom) for the treatment of patients with noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis In April 2024, product shipped and first patients received Rezdiffra, the first and only medication approved by the FDA for the treatment of NASH (also known as "MASH") On March 5, 2024, announced validation of European Medicines Agency marketing application for resmetirom Raised $690 million in gross proceeds from upsized public offering and full over-allotment exercise Reports cash, cash equivalents and marketable securities of $1.1 billion at March 31, 2024 Company to host conference call today, May 7, 2024, at 8 a.m. EDT CONSHOHOCKEN, Pa., May 07, 2024 (GLOBE NEWSWIRE) -- 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 UpdateOn 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-β agonist designed to target key underlying causes of NASH. Rezdiffra positioned to address significant patient need as first-ever medicine approved for NASH. NASH with moderate to advanced liver fibrosis is a serious and progressive liver disease, and Rezdiffra is the first and only FDA-approved therapy for the condition. 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 focused on the approximately 315,000 diagnosed patients with NASH with moderate to advanced liver fibrosis under the care of specialist physicians. Strong label positions Rezdiffra as a foundational therapy for NASH. The accelerated approval of Rezdiffra was based on results from the Phase 3 MAESTRO-NASH trial, which was published in The New England Journal of Medicine in February 2024. This includes data demonstrating Rezdiffra stops or improves fibrosis in more than 80% of patients. The Rezdiffra prescribing information includes simple, weight-based dosing, does not include a liver biopsy requirement for diagnosis, contains no contraindications, no boxed warnings and no monitoring requirements beyond standard of care. Experienced team executing on U.S. specialty launch. Madrigal built an expert team across sales, medical affairs, market access and patient support that is executing on the Rezdiffra launch. The sales team is engaging with healthcare providers to educate on NASH and Rezdiffra and activate offices to process prescriptions with the support from Madrigal patient services. The market access team is meeting with national and regional payers to establish coverage and increase patient access to Rezdiffra. Rezdiffra started shipping to customers in April. Expanding access to Rezdiffra outside of the U.S. In March, the Company announced that its Marketing Authorization Application (MAA) for resmetirom for the treatment of NASH/MASH with liver fibrosis was validated and under evaluation with the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP). Resmetirom has the potential to become the first therapy for patients with NASH/MASH with liver fibrosis to receive approval in Europe. First Quarter and Recent Corporate Updates Raised $690 million from upsized public offering and full over-allotment option exercise. On March 21, 2024, the Company closed an upsized public offering, which generated gross proceeds of $600 million. On April 2, 2024, the Company closed the underwriters' exercise in full of their option to purchase additional shares for an additional $90 million gross proceeds. Total net proceeds were $660 million after deducting fees and commissions. These proceeds further strengthen the Company's balance sheet and fully resource the Rezdiffra launch. New appointment to the Madrigal leadership team. On February 28, 2024, the Company announced the appointment of Mardi C. Dier as Chief Financial Officer (CFO). Ms. Dier has spent more than 20 years in executive financial leadership roles in biotechnology companies, including CFO positions at Portola Pharmaceuticals, Ultragenyx, and Acelyrin. MAESTRO-NASH results published in NEJM. On Feb. 8, 2024, positive results from the 52-week pivotal Phase 3 MAESTRO-NASH were published in The New England Journal of Medicine, including detailed analyses that reinforce the safety and efficacy profile of Rezdiffra. MAESTRO-NASH is a multicenter, randomized, double-blind, placebo-controlled Phase 3 study of Rezdiffra in patients with liver biopsy-confirmed NASH. Health economic abstracts presented at NASH-TAG. Five Madrigal health economic abstracts were presented at the NASH-TAG conference, which took place January 4-6, 2024, in Park City, Utah. Abstracts highlighted the serious clinical burden of uncontrolled NASH and identified opportunities to improve patient care. First-Quarter 2024 Financial Results Total revenues: The Company shipped Rezdiffra beginning in April. No revenue was booked in the first quarter. Operating Expenses: First-quarter 2024 operating expenses were $152.0 million, compared to $78.3 million in the comparable prior year period. The increase is primarily attributable to expenses incurred related to commercial preparation activities. R&D Expense: First-quarter 2024 R&D expense was $71.2 million, compared to $62.2 million in the comparable prior year period. The increase is primarily attributable to an increase related to timing of manufacturing, headcount and stock compensation expense. SG&A Expense: First-quarter 2024 SG&A expense was $80.8 million, compared to $16.2 million in the comparable prior year period. The increase is primarily attributable to increases in commercial preparation activities for the launch of Rezdiffra, including significant commercial headcount expansion and stock compensation expense. Interest Income: First-quarter 2024 interest income was $8.3 million, compared to $3.8 million in the comparable prior year period. The increase in interest income is due primarily to a higher average principal balance in our investment account as well as higher average interest rate. Interest Expense: First-quarter 2024 interest expense was $3.8 million, compared to $2.3 million in the comparable prior year period. The increase in interest expense was a result of the higher outstanding principal balances during the period under the Company's loan facility as well as higher average interest rate. Cash, Cash Equivalents and Marketable Securities: As of March 31, 2024, Madrigal had cash, cash equivalents and marketable securities of $1.1 billion, compared to $634.1 million at Dec. 31, 2023. The increase in cash and marketable securities was attributable to the March 2024 public offering partially offset by funding of operations. Conference Call and WebcastAt 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. 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 PharmaceuticalsMadrigal 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 StatementsThis 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, ...