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马德里制药公司2025年季度报告

2025-11-04美股财报肖***
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马德里制药公司2025年季度报告

xQUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGEACT OF 1934 For the quarterly period endedSeptember 30, 2025 OR oTRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGEACT OF 1934 For the transition period fromto Commission file number:001-33277 MADRIGAL PHARMACEUTICALS, INC. Delaware04-3508648(State or other jurisdiction ofincorporation or organization)(I.R.S. EmployerIdentification No.) Four Tower Bridge200 Barr Harbor Drive,Suite 200West Conshohocken,Pennsylvania(Address of principal executive offices) 19428(Zip Code) Registrant’s telephone number, including area code: (267)824-2827 Former name, former address and former fiscal year, if changed since last report: Securities registered pursuant to Section 12(b) of the Act: The NASDAQ Stock Market LLC Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reportingcompany or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and“emerging growth company” in Rule 12b-2 of the Exchange Act. If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complyingwith any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act.o Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).Yes o Nox As ofOctober30, 2025, the registrant had22,711,420shares of common stock outstanding. TABLE OF CONTENTS ItemDescriptionPagePart I. Financial Information5Item 1.Financial Statements (Unaudited):5Condensed Consolidated Balance Sheets atSeptember30, 2025 and December 31, 20245Condensed Consolidated Statements of Operations for the Three andNineMonths EndedSeptember30, 2025 and20246Condensed Consolidated Statements of Comprehensive Loss for the Three and Nine Months Ended September 30,2025 and 20247Condensed Consolidated Statements of Stockholders’ Equity for the Three andNineMonths EndedSeptember30,2025 and 20248Condensed Consolidated Statements of Cash Flows for theNineMonths EndedSeptember30, 2025 and 20247Notes to Condensed Consolidated Financial Statements11Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations27Item 3.Quantitative and Qualitative Disclosures About Market Risk37Item 4.Controls and Procedures37Part II. Other Information38Item 1.Legal Proceedings38Item 1A.Risk Factors38Item 2.Unregistered Sales of Equity Securities and Use of Proceeds38Item 3.Defaults Upon Senior Securities38Item 4.Mine Safety Disclosures38Item 5.Other Information38Item 6.Exhibits39Signatures41 CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This Quarterly Report on Form 10-Q (this “Quarterly Report”) includes “forward-looking statements” made pursuant to the safeharbor provisions of the Private Securities Litigation Reform Act of 1995 that are based on our beliefs and assumptions and on informationcurrently available to us, but are subject to factors beyond our control. Forward-looking statements: reflect management’s current knowledge,assumptions, judgment and expectations regarding future performance or events; include all statements that are not historical facts; and can beidentified by terms such as “accelerate,” “achieve,” “may,” “will,” “should,” “could,” “would,” “expects,” “plans,” “anticipates,” “goal,”“believes,” “estimates,” “positions,” “predictive,” “projects,” “predicts,” “intends,” “potential,” “continue,” “seeks” and similar expressions andthe negatives of those terms. In particular, forward-looking statements contained in this Quarterly Report relate to, among other things: •our ability to successfully commercialize Rezdiffra, our only approved product, for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”) with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis);•our ability to obtain and maintain full approval for Rezdiffra from the U.S. Food and Drug Administration and the EuropeanCommission;•our ability to successfully, or in a timely manner, report positive results from our outcomes trials;•our ability to obtain and maintain regulatory approval to expand Rezdiffra’s indication to a broader MASH patientpopulation;•our expectations regarding the degree of market acceptance of Rezdiffra by physicians, patients, third-party payors and othersin the healthcare community, our ability to obtain and maintain adequate reimbursement from government and third-partypayors for Rezdiffra or acceptable prices for Rezdiffra and Rezdiffra’s potential sector leadership;•our ability to effectively scale our operations in Europe to successfully commercialize Rezdiffra;•our possible or assumed future business strategies and plans (including potential ex-U.S. commercial or partneringopportunities) and po