Now, the picture is shifting, and the odds are good that one of these players will pull ahead of the other, thereby becoming the better biotech-stock investment. The only questions are, which will it be, and for how long will it last? Let's dive in. In the future, the company hopes to pick up an indication for more severe forms of fibrosis as well as cirrhosis, and it's currently pursuing clinical trials on that front. Being able to treat cirrhosis would expand its addressable market significantly, but inve ...

Core Insights - Rezdiffra shows potential in treating patients with NASH and moderate to advanced liver fibrosis by reversing fibrosis and preventing disease progression [1][28] - The Phase 3 MAESTRO-NASH trial demonstrated that Rezdiffra achieved both primary endpoints of fibrosis improvement and NASH resolution [10][28] - Rezdiffra treatment resulted in significant improvements in health-related quality of life (HRQL) for patients with NASH [4][5][28] Group 1: Treatment Efficacy - Noninvasive test data over three years indicate a durable treatment response to Rezdiffra, with 91% of treated patients showing improved or stable liver stiffness compared to placebo [2][28] - Both doses of Rezdiffra (80 mg and 100 mg) demonstrated similar improvements in liver stiffness and fat content, predicting fibrosis improvement and NASH resolution [3][28] - In patients with MetALD, Rezdiffra achieved fibrosis improvement rates of 88% for the 100 mg dose and 81% for the 80 mg dose, compared to 14% in the placebo group [7][28] Group 2: Health-Related Quality of Life - Patients receiving Rezdiffra showed significant improvements in HRQL scores, particularly in the Worry domain of the Chronic Liver Disease Questionnaire-NASH [5][28] - Biopsy responders with stage F3 fibrosis at baseline experienced more pronounced HRQL improvements compared to those with lower fibrosis stages [5][28] Group 3: Study Design and Future Directions - The MAESTRO-NASH trial enrolled 1,759 patients with biopsy-confirmed NASH, with ongoing studies to confirm clinical benefits over a 54-month period [8][11][28] - The trial's primary endpoints included NASH resolution without worsening fibrosis and improvement in fibrosis by at least one stage [9][28] - Continued approval for Rezdiffra may depend on the verification of clinical benefits in ongoing confirmatory trials [28]

It's not the most prominent biotech, but it has an important claim to fame. Madrigal Pharmaceuticals' (MDGL -0.79%) shares are down by 27% over the past year, while the S&P 500 is up by 26%. However, this poor performance hardly reflects the progress the biotech has made. Madrigal recently earned regulatory approval for Rezdiffra, a therapy for non-alcoholic steatohepatitis (NASH). Not only was Rezdiffra Madrigal's first product on the market, but it is also the first and only approved by the U.S. Food and ...

Financial Data and Key Metrics Changes - The company recorded no revenue from Rezdiffra in the first quarter of 2024 as initial shipments began in April [51] - The net cash balance as of March 31, 2024, stood at $1.1 billion, bolstered by a public offering that raised $690 million [53][32] - SG&A expenses increased to $81 million compared to $16 million in the first quarter of 2023, reflecting the scale-up of commercial operations [59] Business Line Data and Key Metrics Changes - The company is focused on establishing Rezdiffra as the foundational therapy for NASH patients with moderate to advanced fibrosis, with a strong product profile and first-to-market advantage [23][34] - The launch strategy includes targeting the right physicians, with 75% of prescriptions coming from top targets [38][44] Market Data and Key Metrics Changes - The company expects full Medicare coverage to be in place by early next year, which will facilitate patient flow through physician offices [36] - Coverage is currently in place for 30% of commercial lives, with a target of 80% by year-end [42] Company Strategy and Development Direction - The company aims to be the leading player in NASH, with plans for geographic expansion and a robust pipeline beyond Rezdiffra [9][31] - The strategy includes building care pathways for NASH patients and engaging with payers to ensure coverage [39][63] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the launch of Rezdiffra, citing overwhelming positive feedback from prescribers and a significant unmet need in the NASH market [21][58] - The company is optimistic about the potential for Rezdiffra to alleviate the financial burden of NASH, with a focus on patient education and support [47][48] Other Important Information - The company is advancing the MAESTRO-NASH outcomes trial, which could provide first-in-disease outcomes data years ahead of competitors [32][40] - The company has established a comprehensive patient support program to assist patients with co-pay assistance and access to the medication [108] Q&A Session Summary Question: Can you discuss the early payer coverage and the VA decision? - Management indicated that there is no read-through from the VA decision to other payers, as each makes independent decisions [88] Question: What proportion of top physician targets have written prescriptions? - Most prescriptions are coming from the top 6,000 target physicians, with many going through medical exceptions due to the lack of established pathways [64][65] Question: How is the company addressing patient services and free drug availability? - The company has a comprehensive patient support program, including co-pay assistance and potential free drug for underinsured patients [108][103] Question: What are the expectations for revenue in 2024? - Revenue is expected to be back-end loaded for the year, with modest sales anticipated in the second quarter due to the time required to wire the system [92][51]

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 ended March 31, 2024 Table of Contents OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-33277 _________________________ MADRIGAL PHARMACEUTICALS, INC. (Exact name of regis ...

Exhibit 99.1 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 pa ...

mikkelwilliam Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) achieved history in March by garnering US FDA approval for Rezdiffra (resmetirom), the first drug specifically indicated for nonalcoholic steatohepatitis (NASH). On April 9, 2024, MDGL announced the availability of Rezdiffra meaning the launch of this first-to-market drug is now underway. In this article, I consider the prospects of the drug and the expectations I think the market might have. The approval and the market MDGL's Rezdiffra is approved ...

CONSHOHOCKEN, Pa., April 24, 2024 (GLOBE NEWSWIRE) -- The Madrigal team is shocked and saddened to learn of the passing of Dr. Stephen Harrison. We offer our deepest condolences to Stephen's family for their loss. Stephen was a colleague and friend to so many of us at Madrigal. He worked tirelessly to improve the lives of people with nonalcoholic steatohepatitis (NASH), and his contributions to the field will touch countless families across the globe for decades to come. So many of the recent innovations an ...

[Corporate Overview and Recent Developments](index=1&type=section&id=Corporate%20Overview%20and%20Recent%20Developments) Madrigal Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing novel therapeutics for nonalcoholic steatohepatitis (NASH) [Introduction and CEO Statement](index=1&type=section&id=Introduction%20and%20CEO%20Statement) Madrigal Pharmaceuticals, a clinical-stage biopharmaceutical company, is advancing resmetirom for a potential U.S. launch as the first approved NASH medicine - Madrigal Pharmaceuticals is a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH)[1](index=1&type=chunk) - The company is focused on advancing regulatory, operational, and commercial activities for resmetirom in preparation for a potential U.S. launch[2](index=2&type=chunk) - The goal is to establish resmetirom as the foundational therapy for NASH with significant fibrosis, addressing a serious disease with significant unmet need[2](index=2&type=chunk) [Recent Corporate Updates](index=1&type=section&id=Recent%20Corporate%20Updates) Madrigal announced key leadership appointments and highlighted significant progress in clinical and regulatory efforts for resmetirom, including positive Phase 3 trial results - Mardi C. Dier was appointed as Chief Financial Officer, bringing over **20 years of executive financial leadership experience** in biotechnology[4](index=4&type=chunk)[5](index=5&type=chunk) - Additional leadership appointments include Carole Huntsman (CCO), Ronald Fillipo (CIO), Clint Wallace (CHRO), Mark Barrett (CBO), and Tina Ventura (CIRO)[5](index=5&type=chunk) - Resmetirom is anticipated to become the first medicine approved for NASH, with a PDUFA date of **March 14, 2024**[4](index=4&type=chunk) - Positive results from the 52-week pivotal Phase 3 MAESTRO-NASH trial were published in the New England Journal of Medicine on **February 8, 2024**, reinforcing resmetirom's safety and efficacy profile[5](index=5&type=chunk) - New data from the MAESTRO-NASH trial, demonstrating broad treatment effects on noninvasive measures of liver health, were presented at the AASLD Liver Meeting in **November 2023**[6](index=6&type=chunk) [Financial Results for the Three and Twelve Months Ended December 31, 2023](index=2&type=section&id=Financial%20Results%20for%20the%20Three%20and%20Twelve%20Months%20Ended%20December%2031%2C%202023) This section details Madrigal's financial performance, including cash position, operating expenses, and other income/expenses for the specified periods [Financial Highlights (Cash Position)](index=2&type=section&id=Financial%20Highlights%20%28Cash%20Position%29) Madrigal's cash, cash equivalents, and marketable securities significantly increased to **$634.1 million** by December 31, 2023, primarily driven by proceeds from a public offering Cash, Cash Equivalents and Marketable Securities | Metric | December 31, 2023 (in millions) | December 31, 2022 (in millions) | | :-------------------------------- | :------------------------------ | :------------------------------ | | Cash, cash equivalents and marketable securities | $634.1 | $358.8 | - The increase in cash and marketable securities was primarily from proceeds from the October 2023 public offering, partially offset by funding of operations[7](index=7&type=chunk) [Operating Expenses Analysis](index=2&type=section&id=Operating%20Expenses%20Analysis) Total operating expenses increased significantly for both the three and twelve months ended December 31, 2023, driven by R&D and G&A activities for resmetirom's launch Total Operating Expenses | Period | 2023 (in millions) | 2022 (in millions) | YoY Change | | :-------------------- | :----------------- | :----------------- | :--------- | | Three Months Ended Dec 31 | $117.2 | $85.3 | +37.4% | | Twelve Months Ended Dec 31 | $380.5 | $293.6 | +29.6% | [Research and Development (R&D) Expenses](index=2&type=section&id=Research%20and%20development%20expenses) R&D expenses increased for the twelve months, driven by manufacturing scale-up and personnel for resmetirom's launch Research and Development Expenses | Period | 2023 (in millions) | 2022 (in millions) | YoY Change | | :-------------------- | :----------------- | :----------------- | :--------- | | Three Months Ended Dec 31 | $70.6 | $70.7 | -0.1% | | Twelve Months Ended Dec 31 | $272.4 | $245.4 | +11.0% | - The increases in R&D expenses are primarily attributable to a scale-up of manufacturing activities to prepare for the launch of resmetirom, as well as an increase in R&D personnel[9](index=9&type=chunk) [General and Administrative (G&A) Expenses](index=2&type=section&id=General%20and%20administrative%20%28G%26A%29%20expenses) G&A expenses significantly increased due to commercialization activities in preparation for resmetirom's expected approval and launch General and Administrative Expenses | Period | 2023 (in millions) | 2022 (in millions) | YoY Change | | :-------------------- | :----------------- | :----------------- | :--------- | | Three Months Ended Dec 31 | $46.5 | $14.6 | +218.5% | | Twelve Months Ended Dec 31 | $108.1 | $48.1 | +124.7% | - The increases in G&A expenses are primarily attributable to commercial activities in preparation for the expected approval and launch of resmetirom[10](index=10&type=chunk) - G&A expenses are expected to further increase as operating activities associated with the commercialization of resmetirom expand[10](index=10&type=chunk) [Other Income and Expenses](index=2&type=section&id=Other%20Income%20and%20Expenses) Madrigal experienced significant increases in both interest income and interest expense for the three and twelve months ended December 31, 2023, driven by higher balances and rates [Interest Income](index=2&type=section&id=Interest%20income) Interest income substantially increased due to higher average investment balances and interest rates in 2023 Interest Income | Period | 2023 (in millions) | 2022 (in millions) | YoY Change | | :-------------------- | :----------------- | :----------------- | :--------- | | Three Months Ended Dec 31 | $9.0 | $1.1 | +718.2% | | Twelve Months Ended Dec 31 | $19.6 | $2.2 | +790.9% | - The increases in interest income were due primarily to a higher average principal balance in the investment account as well as higher average interest rates in 2023[11](index=11&type=chunk) [Interest Expense](index=2&type=section&id=Interest%20expense) Interest expense rose due to higher outstanding loan balances and increased average interest rates in 2023 Interest Expense | Period | 2023 (in millions) | 2022 (in millions) | YoY Change | | :-------------------- | :----------------- | :----------------- | :--------- | | Three Months Ended Dec 31 | $4.0 | $1.7 | +135.3% | | Twelve Months Ended Dec 31 | $12.7 | $4.0 | +217.5% | - The increase in interest expense was a result of higher outstanding principal balances under the company's loan facility and higher average interest rates in 2023[12](index=12&type=chunk) [Disease and Company Background](index=3&type=section&id=Disease%20and%20Company%20Background) This section provides an overview of Nonalcoholic Steatohepatitis (NASH) and Madrigal Pharmaceuticals' role in developing therapeutics for this disease [About NASH](index=3&type=section&id=About%20NASH) NASH is a severe form of fatty liver disease, a leading cause of liver-related mortality with no FDA-approved therapies, recently re-named MASH - NASH is a more advanced form of nonalcoholic fatty liver disease (NAFLD) and a leading cause of liver-related mortality, posing an increasing burden on healthcare systems globally[13](index=13&type=chunk) - Patients with NASH and significant fibrosis (stages 2 and 3) face dramatically increased risks of adverse liver outcomes, with NASH rapidly becoming the leading cause of liver transplantation in the U.S[14](index=14&type=chunk) - Madrigal estimates approximately **1.5 million diagnosed NASH patients** in the U.S., with about **525,000 having significant fibrosis**, and plans to focus on approximately **315,000 of these patients** under liver specialists during resmetirom's launch[15](index=15&type=chunk) - There are currently no FDA-approved therapies for NASH, which is also known as 'metabolic dysfunction-associated steatohepatitis (MASH)' following a 2023 nomenclature change[16](index=16&type=chunk) [About Madrigal Pharmaceuticals](index=3&type=section&id=About%20Madrigal%20Pharmaceuticals) Madrigal Pharmaceuticals is a clinical-stage biopharmaceutical company dedicated to developing novel therapeutics for NASH, with resmetirom as its lead liver-directed oral therapy - Madrigal Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH)[17](index=17&type=chunk) - Madrigal's lead candidate, resmetirom, is a liver-directed oral therapy designed to target key underlying causes of NASH[17](index=17&type=chunk) [Consolidated Financial Statements](index=6&type=section&id=Consolidated%20Financial%20Statements) This section presents Madrigal's condensed consolidated statements of operations and balance sheets, reflecting the company's financial position and performance [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Madrigal incurred a net loss of **$112.2 million** for Q4 2023 and **$373.6 million** for FY 2023, primarily due to increased R&D and G&A operating expenses Condensed Consolidated Statements of Operations (in thousands) | Metric | Three Months Ended Dec 31, 2023 | Three Months Ended Dec 31, 2022 | Twelve Months Ended Dec 31, 2023 | Twelve Months Ended Dec 31, 2022 | | :------------------------------------ | :------------------------------ | :------------------------------ | :------------------------------- | :------------------------------- | | Total revenues | $ — | $ — | $ — | $ — | | Research and development | $70,640 | $70,742 | $272,350 | $245,441 | | General and administrative | $46,536 | $14,557 | $108,146 | $48,130 | | Total operating expenses | $117,176 | $85,299 | $380,496 | $293,571 | | Loss from operations | $(117,176) | $(85,299) | $(380,496) | $(293,571) | | Interest income, net | $8,953 | $1,076 | $19,578 | $2,185 | | Interest expense | $(3,971) | $(1,682) | $(12,712) | $(3,964) | | Net loss | $(112,194) | $(85,905) | $(373,630) | $(295,350) | | Basic and diluted net loss per common share | $(5.68) | $(4.98) | $(19.99) | $(17.23) | | Basic and diluted weighted average number of common shares outstanding | 19,760,842 | 17,237,517 | 18,687,774 | 17,137,201 | [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of December 31, 2023, Madrigal's total assets increased to **$640.5 million**, primarily driven by a significant rise in cash, cash equivalents, and marketable securities Condensed Consolidated Balance Sheets (in thousands) | Metric | December 31, 2023 | December 31, 2022 | | :------------------------------------ | :----------- | :----------- | | **Assets** | | | | Cash, cash equivalents and marketable securities | $634,131 | $358,774 | | Other current assets | $3,150 | $2,595 | | Other non-current assets | $3,266 | $1,203 | | Total assets | $640,547 | $362,572 | | **Liabilities and Equity** | | | | Current liabilities | $118,548 | $115,894 | | Long-term liabilities | $116,666 | $49,289 | | Stockholders' equity | $405,333 | $197,389 | | Total liabilities and stockholders' equity | $640,547 | $362,572 | [Additional Information](index=3&type=section&id=Additional%20Information) This section provides important disclaimers regarding forward-looking statements and contact information for investor and media inquiries [Forward-Looking Statements](index=3&type=section&id=Forward%20Looking%20Statements) This section provides a comprehensive disclaimer regarding forward-looking statements, outlining inherent risks and uncertainties associated with Madrigal's future performance and commercialization plans - The communication includes 'forward-looking statements' based on Madrigal's beliefs and assumptions, subject to factors beyond its control[18](index=18&type=chunk) - These statements are subject to numerous risks and uncertainties, including those related to obtaining and maintaining regulatory approvals, meeting clinical study objectives, market demand, capital raising, and competitive studies[21](index=21&type=chunk) - Undue reliance should not be placed on forward-looking statements, and Madrigal undertakes no obligation to update them; more detailed risk information is available in SEC filings, particularly the Annual Report on Form 10-K[21](index=21&type=chunk)[22](index=22&type=chunk) [Investor and Media Contacts](index=5&type=section&id=Investor%20Contact) This section provides the contact information for investor relations and media inquiries for Madrigal Pharmaceuticals - Investor Contact: Tina Ventura, Madrigal Pharmaceuticals, Inc., IR@madrigalpharma.com[23](index=23&type=chunk) - Media Contact: Christopher Frates, Madrigal Pharmaceuticals, Inc., media@madrigalpharma.com[23](index=23&type=chunk)

Table of Contents UNITEDSTATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _______________________ FORM 10-K _______________________ (Mark One) x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from________ to ________ Commission file number: 001-33277 _______________________ MADRIGAL PHARMACEUTI ...