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Madrigal Pharmaceuticals Announces Preliminary* Fourth-Quarter and Full-Year 2024 Net Sales, Year-End Cash and Total Patients on Rezdiffra
Globenewswire· 2025-01-13 11:45
Business Performance and Financial Updates - Preliminary fourth-quarter 2024 Rezdiffra net sales range between $100 million to $103 million, and full-year 2024 net sales range between $177 million to $180 million [4][5] - Preliminary year-end 2024 cash, cash equivalents, restricted cash, and marketable securities total approximately $931 million [4][5] - Over 11,800 patients were on Rezdiffra therapy as of year-end 2024 [4][5][13] Key Milestones and Achievements - Rezdiffra received U.S. FDA approval on March 14, 2024, becoming the first and only approved therapy for MASH [5] - The Phase 3 MAESTRO-NASH trial results were published in The New England Journal of Medicine and recognized as one of the 14 notable scientific research articles of 2024 [5] - EMA validated the Marketing Authorization Application (MAA) for Rezdiffra on March 5, 2024, with an anticipated decision in mid-2025 and a potential European launch starting in Germany in the second half of 2025 [5] - Enrollment for the MAESTRO-NASH OUTCOMES study, evaluating Rezdiffra in patients with compensated MASH cirrhosis, was completed on October 21, 2024 [5] Market Opportunity and Disease Overview - MASH is a serious liver disease that can progress to cirrhosis, liver failure, liver cancer, and premature mortality, and is expected to become the leading cause of liver transplantation in the U.S. [3][6] - Patients with moderate to advanced liver fibrosis (stages F2 to F3) have a 10-17 times higher risk of liver-related mortality compared to those without fibrosis, while those with cirrhosis face a 42 times higher risk [6] - An estimated 1.5 million patients in the U.S. have been diagnosed with MASH, with approximately 315,000 patients under the care of liver specialists having moderate to advanced fibrosis [7] Strategic Outlook and Growth Opportunities - The company is preparing for European expansion in the second half of 2025, pending EMA approval [5][13] - Positive results from the MAESTRO-NASH OUTCOMES trial could position Rezdiffra as the only treatment for F2 to F4 MASH and the only therapy with outcomes data this decade [13] Leadership and Communication - Bill Sibold, CEO of Madrigal, will present updates at the 43rd Annual J.P. Morgan Healthcare Conference on January 15, 2025, via a live webcast [2][4]
Fast Drug Launch For Madrigal Pharmaceuticals Brings Buyout Discussion
Seeking Alpha· 2025-01-09 11:22
Group 1 - The core viewpoint is that Madrigal Pharmaceuticals has experienced a significant stock increase of over 60% since April 2024, attributed to strong sales performance of its product Rezdiffra in the metabolic-associated steatohepatitis (MASH) market [1] - The first two quarters of Rezdiffra sales have exceeded estimates, indicating a successful product launch [1] Group 2 - The article emphasizes the importance of trading around key events such as trial results and NDA/BLA approvals in the biotech sector [1]
Madrigal Pharmaceuticals to Present at the 43rd Annual J.P. Morgan Healthcare Conference
Globenewswire· 2025-01-03 13:00
Company Presentation - Madrigal Pharmaceuticals will present at the 43rd Annual J P Morgan Healthcare Conference on January 15 2025 at 2 15 pm PT [1] - The presentation will be webcast live and accessible via Madrigalâs Investor Relations Site Events and Presentations [1] Company Overview - Madrigal Pharmaceuticals is a biopharmaceutical company focused on developing novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH) a liver disease with significant unmet medical needs [2] - The companyâs lead medication Rezdiffra (resmetirom) is a once-daily oral liver-directed THR-β agonist designed to target key underlying causes of MASH [2] Contact Information - Investor inquiries can be directed to Tina Ventura at IR@madrigalpharma com [3] - Media inquiries can be directed to Christopher Frates at media@madrigalpharma com [3]
Madrigal (MDGL) Just Flashed Golden Cross Signal: Do You Buy?
ZACKS· 2024-11-22 15:56
Madrigal Pharmaceuticals, Inc. (MDGL) reached a significant support level, and could be a good pick for investors from a technical perspective. Recently, MDGL's 50-day simple moving average broke out above its 200-day moving average; this is known as a "golden cross."A golden cross is a technical chart pattern that can signify a potential bullish breakout. It's formed from a crossover involving a security's short-term moving average breaking above a longer-term moving average, with the most common moving av ...
Wall Street Analysts Believe Madrigal (MDGL) Could Rally 26.44%: Here's is How to Trade
ZACKS· 2024-11-18 16:00
Shares of Madrigal (MDGL) have gained 34.6% over the past four weeks to close the last trading session at $288.58, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $364.87 indicates a potential upside of 26.4%.The average comprises 15 short-term price targets ranging from a low of $155 to a high of $507, with a standard deviation of $81.13. While the lowest estimate indicates a d ...
Here's Why Madrigal (MDGL) is a Great Momentum Stock to Buy
ZACKS· 2024-11-07 18:00
Momentum investing revolves around the idea of following a stock's recent trend in either direction. In the 'long' context, investors will be essentially be "buying high, but hoping to sell even higher." With this methodology, taking advantage of trends in a stock's price is key; once a stock establishes a course, it is more than likely to continue moving that way. The goal is that once a stock heads down a fixed path, it will lead to timely and profitable trades.Even though momentum is a popular stock char ...
Madrigal Pharmaceuticals, Inc. Announces Participation at Three Upcoming Investor Conferences
GlobeNewswire News Room· 2024-11-06 13:00
CONSHOHOCKEN, Pa., Nov. 06, 2024 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (Nasdaq: MDGL) today announced that the company will participate in fireside chats at three upcoming investor conferences: UBS Global Healthcare Conference 2024Wednesday, November 13, 2024 at 2:00 P.M. ESTThe presentation will be webcast live and may be accessed here. 7th Annual Evercore HealthCONx ConferenceWednesday, December 4, 2024 at 9:35 A.M. EST Piper Sandler 36th Annual Healthcare ConferenceThursday, December 5, 2024 ...
Madrigal Q3 Earnings Beat, NASH Drug Sales Drive Top Line, Stock Up
ZACKS· 2024-11-01 14:46
Madrigal Pharmaceuticals (MDGL) reported third-quarter 2024 loss of $4.92 per share, narrower than the Zacks Consensus Estimate of a loss of $6.94 per share. In the year-ago quarter, the company reported a loss of $5.34 per share.During the quarter, the company generated total revenues of $62.2 million — entirely from product sales of its recently approved nonalcoholic steatohepatitis (NASH) drug Rezdiffra (resmetirom), which was commercially launched this April. The metric beat the Zacks Consensus Estimate ...
Madrigal Pharmaceuticals(MDGL) - 2024 Q3 - Earnings Call Transcript
2024-10-31 18:50
Financial Data and Key Metrics Changes - The company reported net sales of $62 million for Q3 2024, reflecting strong demand and exceeding expectations [7][35] - R&D expenses for Q3 2024 were $68.7 million, down from $71 million in Q3 2023, indicating stable R&D spending [39] - SG&A expenses increased to $107.6 million from $27.6 million in Q3 2023, primarily due to the expansion of commercial operations following Rezdiffra's approval [39] - The company had $1 billion in cash and marketable securities as of September 30, 2024, providing a strong financial position to support ongoing operations [40] Business Line Data and Key Metrics Changes - The launch of Rezdiffra has seen over 6,800 patients on the drug by the end of Q3 2024, a significant increase from over 2,000 patients at the end of Q2 2024 [10] - The company achieved coverage for more than 80% of commercial lives for Rezdiffra, ahead of schedule [13] - Approximately 40% of top prescribers have prescribed Rezdiffra, doubling the penetration rate from the previous quarter [17] Market Data and Key Metrics Changes - The company is targeting 315,000 patients diagnosed with NASH with moderate to advanced fibrosis, with only 2% currently on treatment [25] - The market for NASH treatment is expected to expand significantly, with the potential for combination therapies as 25% of Rezdiffra patients are already using it alongside GLP-1s for comorbidities [27] Company Strategy and Development Direction - The company aims to strengthen its leadership position in the NASH market through the successful launch of Rezdiffra and plans for a European launch in the second half of 2025 [29] - The company is focused on building a pipeline beyond Rezdiffra, looking for opportunities in NASH and potential combination therapies [119] - The management emphasizes the importance of establishing Rezdiffra as the foundational therapy for NASH, supported by positive clinical outcomes and real-world data [22][34] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future market dynamics, citing Rezdiffra's strong product profile and the significant opportunity to penetrate the target market [28] - The management noted that the early launch metrics are crucial indicators of future success, with growth tracking well against benchmarks from other successful specialty medicine launches [45] - The company is preparing for potential competition from GLP-1 therapies, which could further accelerate the growth opportunity for Rezdiffra [25][26] Other Important Information - The company completed enrollment in its MAESTRO-NASH OUTCOMES trial, which could position Rezdiffra as the first therapy for patients with compensated NASH cirrhosis [30][31] - The company is enhancing its R&D capabilities with the appointment of Dr. Michael Charlton as Head of Clinical Development, a recognized expert in NASH [32] Q&A Session Summary Question: Future growth expectations for Q4 and 2025 - Management is pleased with the strong launch progress and anticipates growth in Q4 and 2025 based on current performance metrics [44][46] Question: Cadence of new patient starts - The company is steadily adding patients and prescribers, with expectations for continued growth as the market becomes more established [50] Question: Free drug program utilization - Very little free drug was utilized in the recent quarter, indicating strong coverage and access for patients [64] Question: Persistence and default rates for patients - Management is optimistic about early patient persistence but will need more time to quantify specific rates [116] Question: Business development strategy - The company aims to build a pipeline focused on NASH and is open to evaluating new opportunities that align with its leadership position [119]
Madrigal Pharmaceuticals(MDGL) - 2024 Q3 - Quarterly Report
2024-10-31 13:02
Table of Contents _________________________ _________________________ _________________________ Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, $0.0001 Par Value Per Share MDGL The NASDAQ Stock Market LLC _________________________ UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _________________________ FORM 10-Q (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period e ...