Item 9A. Controls and Procedures
Item 9A. Controls and Procedures.
Disclosure Controls and Procedures
We maintain disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) that are designed to provide reasonable assurance that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our chief executive officer and chief financial officer, as appropriate, to allow timely decisions regarding required disclosure.
Under the supervision of our principal executive officer and principal financial officer, we evaluated the effectiveness of our disclosure controls and procedures as of the end of the period covered by this Annual Report. Based on that evaluation, our principal executive officer and principal financial officer have concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of December 31, 2025.
Limitations on the Effectiveness of Controls and Procedures
In designing and evaluating our disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable, not absolute, assurance of achieving the desired control objectives. In addition, the design of disclosure controls and procedures must reflect the fact that there are resource constraints and that management is required to apply judgment in evaluating the benefits of possible controls and procedures relative to their costs. The design of any disclosure controls and procedures also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions.
Management’s Report On Internal Control Over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) for our company. Internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with GAAP. This process includes those policies and procedures that (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of our assets; (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with GAAP, and that our receipts and expenditures are being made only in accordance with authorizations of our management and directors; and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on our financial statements. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
Our management, including our principal executive officer and our principal financial officer, assessed the effectiveness of our internal control over financial reporting as of December 31, 2025. In making this assessment, our management used the criteria set forth in the “Internal Control—Integrated Framework” issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework). Based on its assessment under that framework, our management concluded that our internal control over financial reporting was effective as of December 31, 2025.
PricewaterhouseCoopers LLP, an independent registered public accounting firm, has audited the effectiveness of our internal control over financial reporting as of December 31, 2025, as stated in its report, which is included herein.
Changes in Internal Control Over Financial Reporting
There were no changes in our internal control over financial reporting (as defined in Rule 13a-15(f) under the Exchange Act) for the quarter ended December 31, 2025 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
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Item 9B. Other Information.
Director and Executive Officer 10b5-1 Plans
During our fiscal quarter ended December 31, 2025, none of our directors or officers adopted or terminated a "Rule 10b5-1 trading plan" or a "non-Rule 10b5-1 trading arrangement," as each is defined in Item 408 of Regulation S-K.
Executive Severance Agreements
On February 18, 2026, we entered into new severance and change of control agreements with certain of our employees, including certain of our named executive officers, pursuant to which certain severance provisions were modified to align with prevailing market practices for similarly situated companies. We entered into agreements (each, a "Severance Agreement") with Mardi Dier, our Executive Vice President and Chief Financial Officer, Carole Huntsman, our Executive Vice President and Chief Commercial Officer, Shannon Kelley, our Executive Vice President and Chief Legal Officer, and David Soergel, our Executive Vice President and Chief Medical Officer.
Pursuant to each Severance Agreement, in the event that such officer’s employment is terminated by us other than for “Cause” (as defined in the applicable agreement) or if the officer resigns for “Good Reason” (as defined in the applicable agreement) during the one-year period following a Change of Control (as defined in the applicable agreement), such officer will be entitled to (i) a lump sum payment equal to 18 months of such officer’s then-current base salary, (ii) a separation bonus in an amount equal to 150% of the target annual bonus to which such officer would have been entitled in the year in which the qualifying separation occurs and (iii) subject to the requirements of COBRA, continuation of medical and dental benefits at our cost (except for named executive officer’s applicable contribution portion and co-pay) for up to 18 months following a qualifying separation. The other terms and conditions of the Severance Agreements are substantially the same as has been previously disclosed.
The foregoing summary of the Severance Agreements does not purport to be complete and is qualified in its entirety by reference to the full text of each Severance Agreement, copies of which are filed as exhibits to this Annual Report.
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.
Not applicable.
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PART III
Item 10. Directors, Executive Officers and Corporate Governance.
Incorporated by reference from the information in our Proxy Statement for our 2026 Annual Meeting of Stockholders, which we will file with the SEC within 120 days of the end of the fiscal year to which this Annual Report relates.
Item 11. Executive Compensation.
Incorporated by reference from the information in our Proxy Statement for our 2026 Annual Meeting of Stockholders, which we will file with the SEC within 120 days of the end of the fiscal year to which this Annual Report relates.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
Incorporated by reference from the information in our Proxy Statement for our 2026 Annual Meeting of Stockholders, which we will file with the SEC within 120 days of the end of the fiscal year to which this Annual Report relates.
Item 13. Certain Relationships and Related Transactions, and Director Independence.
Incorporated by reference from the information in our Proxy Statement for our 2026 Annual Meeting of Stockholders, which we will file with the SEC within 120 days of the end of the fiscal year to which this Annual Report relates.
Item 14. Principal Accountant Fees and Services.
Incorporated by reference from the information in our Proxy Statement for our 2026 Annual Meeting of Stockholders, which we will file with the SEC within 120 days of the end of the fiscal year to which this Annual Report relates.
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PART IV
Item 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
Item 15(a) The following documents are filed as part of, or incorporated by reference into, this Annual Report:
Item 15(a)(1) and (2) The Consolidated Financial Statements beginning on page F-1 are filed as part of this Annual Report. Other financial statement schedules have been omitted because the information required to be presented in them is not applicable or is shown in the financial statements or related notes.
Item 15(a)(3) We have filed, or incorporated into this Annual Report by reference, the exhibits listed on the accompanying Exhibit Index.
Item 15(b) See Item 15(a)(3) above.
Item 15(c) See Item 15(a)(2) above.
Exhibit
Number Exhibit Description Filed
Herewith
Incorporated by
Reference herein
from Form or
Schedule
Filing Date SEC File /
Registration
Number
3.1 Restated Certificate of Incorporation of the Registrant.
Form 10-K (Exhibit 3.1) 3/31/2017 001-33277
3.2 Certificate of Amendment to Restated Certificate of Incorporation of the Registrant , as filed on June 16, 2023 with the Secretary of State of the State of Delaware .
Form 8-K
(Exhibit 3.1)
6/20/2023 001-33277
3.3 Certificate of Designation of Preferences, Rights and Limitations of Series A Convertible Preferred Stock.
Form 8-K
(Exhibit 3.1)
6/21/2017 001-33277
3.4 Certificate of Designation of Preferences, Rights and Limitations of Series B Convertible Preferred Stock .
Form 8-K
(Exhibit 3.1)
12/23/2022 001-33277
3.5 Bylaws of the Registrant, as amended April 13, 2016.
Form 8-K
(Exhibit 3.1)
4/14/2016 001-33277
4.1 Form of Warrant Agreement, dated May 9, 2022, between the Registrant and Hercules Capital, Inc. and affiliates.
Form 10-Q (Exhibit 4.1) 08/04/2022 001-33277
4.2† Form of Tranche 2 Warrant Agreement, dated February 3, 2023, by and among the Registrant and Hercules Capital, Inc. and affiliates.
Form 8-K
(Exhibit 4.1)
2/9/2023 001-33277
4.3 Form of Pre-Funded Warrant of the Registrant .
Form 8-K
(Exhibit 4.1)
10/2/2023 001-33277
4.4 Description of Securities of the Registrant.
Form 10-K (Exhibit 4.3) 2/23/2023 001-33277
Equity Agreements
10.1 Securities Purchase Agreement, dated June 20, 2017, by and among the Registrant and the investors party thereto, including the Registration Rights Agreement attached as Exhibit B thereto.
Form 8-K
(Exhibit 10.1)
6/21/2017 001-33277
10.2 Amendment No. 2, dated December 22, 2022, to Securities Purchase Agreement, dated June 20, 2017, by and among the Registrant and the investors listed on the signature pages thereto.
Form 8-K
(Exhibit 10.2)
12/23/2022 001-33277
10.3 Sales Agreement, dated May 7, 2024, by and between the Registrant and TD Securities (USA) LLC.
Form 8-K
(Exhibit 1.1)
5/7/2024 001-33277
10.4 Securities Purchase Agreement, dated December 21, 2022, by and among the Registrant and the institutional investors listed on the signature pages thereto.
Form 8-K
(Exhibit 10.1)
12/23/2022 001-33277
10.6 Registration Rights Agreement, dated August 7, 2023, by and among the Registrant, 667, L.P. and Baker Brothers Life Sciences, L.P.
Form 10-Q (Exhibit 10.2) 8/8/2023 001-33277
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Debt Agreements
10.7†#
Financing Agreement by and among the Registrant , certain subsidiaries of the Registrant , certain funds managed by Blue Owl Capital Corporation and LSI Financing LLC, dated as of July 17, 2025 (as amended by the First Amendment thereto, dated as of September 4, 2025).
Form 10-Q (Exhibit 10.1)
11/04/2025 001-33277
10.8†
Second Am endment Agreement, dated as of December 30, 2025, among the Registrant , certain subsidiaries of the Registrant, certain funds managed by Blue Owl Cap ital Corporation and LSI Financing LLC
X
Agreements with Respect to Collaborations, Licenses, Research and Development
10.9†#
Research, Development and Commercialization Agreement, dated December 18, 2008, by and between Hoffmann-La Roche, Inc., F. Hoffmann-La Roche Ltd and the Registrant.
Form 10-Q (Exhibit 10.5) 11/14/2016 001-33277
10.10#
First Amendment to the Research, Development, and Commercialization Agreement, dated as of January 29, 2026, by and between the Registrant and Roche.
Form 8-K
(Exhibit 10.1)
1/30/2026 001-33277
Equity Compensation Plans
10.11*
Amended 2015 Stock Plan .
Form 8-K (Exhibit 10.1)
6/27/2024 001-33277
10.12*
Form of Incentive Stock Option Agreement under Amended 2015 Stock Plan.
Form 10-K (Exhibit 10.10) 3/31/2017 001-33277
10.13*
Form of Nonqualified Stock Option Agreement under Amended 2015 Stock Plan.
Form 10-K (Exhibit 10.11) 3/31/2017 001-33277
10.14*
Form of Nonqualified Stock Option Agreement for Directors under Amended 2015 Stock Plan (pre-2023).
Form 10-K (Exhibit 10.13) 3/31/2017 001-33277
10.15*
Form of RSU Agreement for Directors under Amended 2015 Stock Plan .
Form 10-Q (Exhibit 10.3) 8/8/2023 001-33277
10.16*
Form of RSU Agreement for Executive Officers (2023) under Amended 2015 Stock Plan .
Form 10-Q (Exhibit 10.4) 8/8/2023 001-33277
10.17*
Form of RSU Agreement for Employees under Amended 2015 Stock Plan .
Form 10-Q (Exhibit 10.5) 8/8/2023 001-33277
10.18*†
2023 Inducement Plan .
Form S-8
(Exhibit 99.1)
9/11/2023 333-27445
10.19*†
Form of Stock Option Agreement under 2023 Inducement Plan .
Form S-8
(Exhibit 99.2)
9/11/2023 333-27445
10.20*†
Form of Restricted Stock Unit Agreement under 2023 Inducement Plan .
Form S-8
(Exhibit 99.3)
9/11/2023 333-27445
10.21 2 025 Inducement Plan.
Form S-8
(Exhibit 99.1)
6/20/2025 333-288200
10.22 Form of Stock Option Agreement under 202 5 Inducement Plan .
Form S-8
(Exhibit 99.2)
6/20/2025 333-288200
10.23 Form of Restricted Stock Unit Agreement under 202 5 Inducement Plan ( N on-Section 16 O fficers) .
Form S-8
(Exhibit 99.3)
6/20/2025 333-288200
10.24 Form of Restricted Stock Unit Agreement under 2023 Inducement Plan (Section 16 O fficers).
Form S-8
(Exhibit 99.4)
6/20/2025 333-288200
10.25 Form of Performance -Based Restricted Stock Unit Agreement under 202 5 Inducement Plan.
Form S-8
(Exhibit 99.5)
6/20/2025 333-288200
Agreements with Executive Officers and Directors
10.26*
Form of Indemnification Agreement between the Registrant and certain directors and executive officers.
Form 10-K (Exhibit 10.20)
2/28/2024 001-33277
10.27*
Letter Agreement, dated April 13, 2016, by and between the Registrant and Rebecca Taub, M.D.
Form 8-K (Exhibit 10.4)
7/22/2016 001-33277
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10.28*†
L etter Agreement, dated April 16, 2025, by and between the Registrant and Rebecca Taub, M . D.
Form 10-Q (Exhibit 10.1)
8/5/2025 001-33277
10.29*†
Letter Agreement (including agreements attached as exhibits thereto), dated September 7, 2023, by and between the Registrant and William J. Sibold .
Form 8-K (Exhibit 10.1)
9/13/2023 001-33277
10.30*†
Letter Agreement (including agreements attached as exhibits thereto), dated November 5, 2023, by and between the Registrant and Carole Huntsman.
Form 10-Q (Exhibit 10.1)
5/7/2024 001-33277
10.31*†
Severance and Change of Control Agreement , dated as of February 18 , 2026, b y and between the Registrant and Carole Huntsman.
X
10.32*†
Letter Agreement (including agreements attached as exhibits thereto), dated February 25, 2024, by and between the Registrant and Mardi Dier.
Form 10-Q (Exhibit 10.2)
5/7/2024 001-33277
10.33*†
Severance and Change of Control Agreement, dated as of February 18, 2026, by and between the Registrant and Mardi Dier.
X
10.34*†
Letter Agreement, dated January 3, 2024, by and between the Registrant and Shannon Kelley, as amended and supplemented by the Letter Agreement, dated August 2, 2024, by and between Madrigal Pharmaceuticals, Inc. and Shannon Kelley.
Form 10-Q (Exhibit 10.1)
10/31/2024 001-33277
10.35*†
Severance and Change of Control Agreement, dated as of February 18, 2026 , by and between the Registrant and Shannon Kelley.
X
10.36*†
L etter Agreement (including agreements attached as exhibits thereto), dated February 12, 2025 , by and between the Registrant and David Soergel.
Form 10-Q (Exhibit 10.2)
8/5/2025 001-33277
10.37*†
Severance and Change of Control Agreement, dated as of February 18, 2026, by and between the Registrant and David Soergel.
X
10.38*
Non- E mployee Director Compensation Policy.
X
Lease
10.39#
Office Lease (with respect to corporate headquarters facility located in West Conshohocken, Pennsylvania) and amendments thereto.
Form 10-K (Exhibit 10.25)
2/26/2025 001-33277
10.40#
First Amendment to Office Lease.
Form 10-K (Exhibit 10.26)
2/26/2025 001-33277
10.41#
Second Amendment to Office Lease.
Form 10-K (Exhibit 10.27)
2/26/2025 001-33277
10.42#
Third Amendment to Office Lease.
Form 10-K (Exhibit 10.28)
2/26/2025 001-33277
10.43#
Fourth Amendment to Office Lease.
Form 10-K (Exhibit 10.29)
2/26/2025 001-33277
10.44#
Fifth Amendment to Office Lease.
Form 10-K (Exhibit 10.30)
2/26/2025 001-33277
10.45#
Sixth Amendment to Office Lease.
Form 10-K (Exhibit 10.31)
2/26/2025 001-33277
10.46#
Seventh Amendment to Office Lease.
Form 10-K (Exhibit 10.32)
2/26/2025 001-33277
10.47#
Eighth Amendment to Office Lease.
Form 10-K (Exhibit 10.33)
2/26/2025 001-33277
10.48#
Ninth Amendment to Office Lease.
Form 10-K (Exhibit 10.34)
2/26/2025 001-33277
10.49#
Lease Agreement, dated as of April 24, 2025, by and between the Registrant and KPG FF Owner, L .P.
Form 10-Q (Exhibit 10.3)
8/5/2025 001-33277
Commercial Supply Agreement
10.50†#
Commercial Supply Agreement, dated as of August 21, 2023, by and between Gregory Pharmaceutical Holdings, Inc. (d/b/a UPM Pharmaceuticals) and th e Registrant.
Form 10-K (Exhibit 10.35)
2/26/2025 001-33277
10.51†#
Resmetirom Commercial Supply Agreement, dated as of December 23, 2024, by and between Evonik Corporation and th e Registrant.
Form 10-K (Exhibit 10.36)
2/26/2025 001-33277
10.52†#
Commercial Supply Agreement, dated as of D ecember 18, 2024, by and between Corden Pharma GmbH and the Registrant (including amendments thereto ).
X
19.1 Insider Trading Policy.
X
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21.1 List of Subsidiaries.
X
23.1 Consent of PricewaterhouseCoopers LLP, Independent Registered Public Accounting Firm.
X
31.1 Certification of Principal Executive Officer required by Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
X
31.2 Certification of Principal Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
X
32.1** Certifications of Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
X
97.1 Incentive Compensation Recovery Policy.
Form 10-K (Exhibit 97.1)
2/28/2024 001-33277
97.2 Supplemental Compensation Recovery Policy.
Form 10-Q (Exhibit 10.3)
5/7/2024 001-33277
101.INS Inline XBRL Instance Document. X
101.SCH Inline XBRL Taxonomy Extension Schema Document. X
101.CAL Inline XBRL Taxonomy Extension Calculation Linkbase Document. X
101.DEF Inline XBRL Taxonomy Extension Definition Linkbase Document. X
101.LAB Inline XBRL Taxonomy Extension Label Linkbase Document. X
101.PRE Inline XBRL Taxonomy Extension Presentation Linkbase Document. X
104 Inline XBRL for the cover page of this Annual Report on Form 10-K, included in the Exhibit 101 Inline XBRL Document Set. X
_____________
* Indicates a management contract, compensatory plan or arrangement.
** The certifications attached as Exhibit 32.1 that accompany this Annual Report on Form 10-K are not deemed filed with the SEC and are not to be incorporated by reference into any filing of the registrant under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Annual Report on Form 10-K, regardless of any general incorporation language contained in any filing.
† Certain portions of this exhibit have been omitted pursuant to Item 601(b)(10)(iv) of Regulation S-K.
# Exhibits and schedules omitted pursuant to Item 601(a)(5) of Regulation S-K.
Item 16. Form 10-K Summary.
None.
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this Report to be signed on its behalf by the undersigned thereunto duly authorized.
MADRIGAL PHARMACEUTICALS INC.
Date: February 19, 2026
By: /s/ WILLIAM J. SIBOLD
William J. Sibold
President and Chief Executive Officer
(Principal Executive Officer)
POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS, that each individual whose signature appears below hereby constitutes and appoints William J. Sibold and Mardi Dier and each or either of them, acting individually, as his or her true and lawful attorney-in-fact and agent, with full power of substitution and resubstitution for him or her and in his or her name, place and stead, in any and all capacities, to sign any and all amendments to this Report, and to file the same, with all exhibits thereto and other documents in connection therewith, with the SEC, granting unto said attorney-in-fact and agent, and each of them, full power and authority to do and perform each and every act and thing requisite and necessary to be done in connection therewith, as fully for all intents and purposes as he or she might or could do in person, hereby ratifying and confirming all that said attorney-in-fact and agent, or any of them, or their or his or her substitutes, may lawfully do or cause to be done or by virtue hereof.
Pursuant to the requirements of the Exchange Act, as amended, this Annual Report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.
Signatures Title Date
/s/ WILLIAM J. SIBOLD President and Chief Executive Officer, Director
(Principal Executive Officer)
February 19, 2026
William J. Sibold
/s/ MARDI C. DIER
Executive Vice President and Chief Financial Officer
(Principal Financial Officer)
February 19, 2026
Mardi C. Dier
/s/ RITA THAKKAR
Senior Vice President and Chief Accounting Officer
(Principal Accounting Officer)
February 19, 2026
Rita Thakkar
/s/ JULIAN C. BAKER
Chair of the Board
February 19, 2026
Julian C. Baker
/s/ REBECCA TAUB, M.D. Director February 19, 2026
Rebecca Taub, M.D.
/s/ PAUL A. FRIEDMAN, M.D.
Director February 19, 2026
Paul A. Friedman, M.D.
/s/ RAYMOND CHEONG, M.D., PH.D.
Director February 19, 2026
Raymond Cheong, M.D., Ph.D.
/s/ RICHARD S. LEVY, M.D. Director February 19, 2026
Richard S. Levy, M.D.
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Signatures Title Date
/s/ JAMES M. DALY Director February 19, 2026
James M. Daly
/s/ JACQUALYN FOUSE, Ph.D.
Director February 19, 2026
Jacqualyn Fouse, Ph.D.
/s/ DANIEL BRENNAN
Director February 19, 2026
Daniel Brennan
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INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
Page
Report of Independent Registered Public Accounting Firm (PCAOB ID 238 )
F- 2
Consolidated Financial Statements:
Consolidated Balance Sheets
F- 4
Consolidated Statements of Operations
F- 5
Consolidated Statements of Comprehensive Loss
F- 6
Consolidated Statements of Stockholders’ Equity
F- 7
Consolidated Statements of Cash Flows
F- 8
Notes to Consolidated Financial Statements
F- 9
F-1
Table of Contents
Report of Independent Registered Public Accounting Firm
To the Board of Directors and Stockholders of Madrigal Pharmaceuticals, Inc.
Opinions on the Financial Statements and Internal Control over Financial Reporting
We have audited the accompanying consolidated balance sheets of Madrigal Pharmaceuticals, Inc. and its subsidiaries (the “Company”) as of December 31, 2025 and 2024, and the related consolidated statements of operations, of comprehensive loss, of stockholders’ equity and of cash flows for each of the three years in the period ended December 31, 2025, including the related notes (collectively referred to as the “consolidated financial statements”). We also have audited the Company's internal control over financial reporting as of December 31, 2025, based on criteria established in Internal Control - Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO).
In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of the Company as of December 31, 2025 and 2024, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2025 in conformity with accounting principles generally accepted in the United States of America. Also in our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2025, based on criteria established in Internal Control - Integrated Framework (2013) issued by the COSO.
Basis for Opinions
The Company's management is responsible for these consolidated financial statements, for maintaining effective internal control over financial reporting, and for its assessment of the effectiveness of internal control over financial reporting, included in Management’s Report On Internal Control Over Financial Reporting appearing under Item 9A. Our responsibility is to express opinions on the Company’s consolidated financial statements and on the Company's internal control over financial reporting based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud, and whether effective internal control over financial reporting was maintained in all material respects.
Our audits of the consolidated financial statements included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. Our audit of internal control over financial reporting included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, and testing and evaluating the design and operating effectiveness of internal control based on the assessed risk. Our audits also included performing such other procedures as we considered necessary in the circumstances. We believe that our audits provide a reasonable basis for our opinions.
Definition and Limitations of Internal Control over Financial Reporting
A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over financial reporting includes those policies and procedures that (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.
F-2
Table of Contents
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
Critical Audit Matters
The critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial statements that was communicated or required to be communicated to the audit committee and that (i) relates to accounts or disclosures that are material to the consolidated financial statements and (ii) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
Recognition of Product Revenue, Net
As described in Note 2 to the consolidated financial statements, the Company recognizes revenue at a point in time when the customer obtains control of promised goods or services in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods or services. Revenue is recorded net of variable consideration, which includes prompt pay discounts, returns, chargebacks, rebates, and co-payment assistance. Total product revenue, net, recognized during the year ended December 31, 2025 was $958.4 million.
The principal consideration for our determination that performing procedures relating to the recognition of product revenue, net is a critical audit matter is a high degree of auditor effort in performing procedures related to the Company’s revenue recognition.
Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the consolidated financial statements. These procedures included testing the effectiveness of controls relating to the revenue recognition process. These procedures also included, among others, (i) testing revenue recognized for a sample of revenue transactions by obtaining and inspecting source documents, such as customer contracts, purchase orders, invoices, proof of delivery and subsequent cash receipts, where applicable; (ii) testing the Company’s reconciliation of gross revenue recognized from product sales to third-party information, and (iii) testing, on a sample basis, variable consideration transactions by obtaining and inspecting source documents such as rebate claims received from indirect customers and corresponding payments, and evaluating for consistency with the contractual terms and the Company’s policies.
/s/ PricewaterhouseCoopers LLP
Philadelphia, Pennsylvania
February 19, 2026
We have served as the Company’s auditor since 2016.
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MADRIGAL PHARMACEUTICALS, INC.
Consolidated Balance Sheets
(in thousands, except share and per share amounts)
December 31,
2025 December 31,
2024
Assets
Current assets:
Cash and cash equivalents $ 198,693 $ 100,019
Restricted cash 5,090 5,000
Marketable securities 784,866 826,232
Trade receivables, net 134,476 53,822
Inventory
74,841 34,068
Prepaid expenses and other current assets 47,804 13,786
Total current assets 1,245,770 1,032,927
Property and equipment, net 1,499 2,190
Intangible assets, net 7,381 4,729
Right-of-use asset 4,939 2,401
Total assets $ 1,259,589 $ 1,042,247
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable $ 48,878 $ 43,599
Accrued liabilities 260,392 124,695
Lease liabilities 1,018 983
Total current liabilities 310,288 169,277
Long term liabilities:
Loan payable, net of discount 339,881 117,569
Lease liabilities 6,731 1,018
Total long term liabilities 346,612 118,587
Total liabilities 656,900 287,864
Stockholders’ equity:
Preferred stock, par value $ 0.0001 per share authorized: 5,000,000 shares at December 31, 2025 and December 31, 2024; 2,369,797 shares issued and outstanding at December 31, 2025 and December 31, 2024
— —
Common stock, par value $ 0.0001 per share authorized: 200,000,000 at December 31, 2025 and December 31, 2024; 22,842,073 and 22,004,679 shares issued and outstanding at December 31, 2025 and December 31, 2024, respectively
2 2
Additional paid-in-capital 2,692,280 2,556,095
Accumulated other comprehensive income 873 468
Accumulated deficit ( 2,090,466 ) ( 1,802,182 )
Total stockholders’ equity 602,689 754,383
Total liabilities and stockholders’ equity $ 1,259,589 $ 1,042,247
See accompanying notes to consolidated financial statements.
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MADRIGAL PHARMACEUTICALS, INC.
Consolidated Statements of Operations
(in thousands, except share and per share amounts)
Year Ended December 31,
2025 2024 2023
Revenues:
Product revenue, net $ 958,403 $ 180,133 $ —
Operating expenses:
Cost of sales 56,148 6,233 —
Research and development 388,525 236,718 272,350
Selling, general and administrative 813,827 435,057 108,146
Total operating expenses 1,258,500 678,008 380,496
Loss from operations ( 300,097 ) ( 497,875 ) ( 380,496 )
Interest income 37,364 46,654 19,578
Interest expense ( 22,309 ) ( 14,671 ) ( 12,712 )
Loss on extinguishment of debt
( 2,779 ) — —
Other expense, net
( 463 ) — —
Net loss $ ( 288,284 ) $ ( 465,892 ) $ ( 373,630 )
Net loss per common share:
Basic and diluted net loss per common share $ ( 12.85 ) $ ( 21.90 ) $ ( 19.99 )
Basic and diluted weighted average number of common shares outstanding 22,434,310 21,272,962 18,687,774
See accompanying notes to consolidated financial statements.
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MADRIGAL PHARMACEUTICALS, INC.
Consolidated Statements of Comprehensive Loss
(in thousands, except share and per share amounts)
Year Ended December 31,
2025 2024 2023
Net loss $ ( 288,284 ) $ ( 465,892 ) $ ( 373,630 )
Other comprehensive income:
Net unrealized gain on available-for-sale securities 392 — 500
Foreign currency translation gain
13 — —
Total other comprehensive income
405 — 500
Comprehensive loss
$ ( 287,879 ) $ ( 465,892 ) $ ( 373,130 )
See accompanying notes to consolidated financial statements.
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MADRIGAL PHARMACEUTICALS, INC.
Consolidated Statements of Stockholders’ Equity
(in thousands, except share and per share amounts)
Preferred stock Common stock Additional
paid-in
Capital Accumulated
other
comprehensive
income (loss)
Accumulated
deficit
Total
stockholders’
equity
Shares Amount Shares Amount
Balance at December 31, 2022 2,369,797 $ — 18,102,523 $ 2 $ 1,160,079 $ ( 32 ) $ ( 962,660 ) $ 197,389
Issuance of common shares in equity offerings, excluding to related parties, net of transaction costs
— — 1,346,199 — 260,187 — — 260,187
Sale of warrants and common shares to related parties and exercise of common stock options, net of transaction costs
— — 426,705 — 270,292 — — 270,292
Stock-based compensation expense related to equity-classified awards — — — — 49,735 — — 49,735
Unrealized gain on marketable securities — — — — — 500 — 500
Hercules warrant — — — — 860 — — 860
Net loss — — — — — — ( 373,630 ) ( 373,630 )
Balance at December 31, 2023 2,369,797 $ — 19,875,427 $ 2 $ 1,741,153 $ 468 $ ( 1,336,290 ) $ 405,333
Issuance of common shares in equity offerings, excluding to related parties, net of transaction costs — — 1,096,153 — 397,487 — — 397,487
Sale of warrants and common shares to related parties and exercise of common stock options, net of transaction costs — — 1,033,099 — 337,575 — — 337,575
Stock-based compensation expense related to equity-classified awards — — — — 79,880 — — 79,880
Net loss — — — — — — ( 465,892 ) ( 465,892 )
Balance at December 31, 2024 2,369,797 $ — 22,004,679 $ 2 $ 2,556,095 $ 468 $ ( 1,802,182 ) $ 754,383
Issuance of common stock under equity plans
— — 837,394 — 38,055 — — 38,055
Stock-based compensation expense related to equity-classified awards — — — — 98,130 — — 98,130
Other comprehensive income
— — — — — 405 — 405
Net loss — — — — — — ( 288,284 ) ( 288,284 )
Balance at December 31, 2025 2,369,797 $ — 22,842,073 $ 2 $ 2,692,280 $ 873 $ ( 2,090,466 ) $ 602,689
See accompanying notes to consolidated financial statements.
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MADRIGAL PHARMACEUTICALS, INC.
Consolidated Statements of Cash Flows
(in thousands, except share and per share amounts)
Year Ended December 31,
2025 2024 2023
Cash flows from operating activities:
Net loss $ ( 288,284 ) $ ( 465,892 ) $ ( 373,630 )
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense 98,130 79,880 49,735
Depreciation and amortization expense 1,506 1,096 527
Amortization of debt issuance costs and discount 1,604 2,089 2,414
Amortization and interest accretion related to operating leases 3,210 ( 400 ) —
Loss on extinguishment of debt
2,779 — —
Changes in operating assets and liabilities:
Trade receivables, net ( 80,654 ) ( 53,822 ) —
Inventory ( 36,978 ) ( 34,068 ) —
Prepaid expenses and other current assets ( 34,018 ) ( 10,636 ) ( 555 )
Accounts payable 5,279 15,558 4,210
Accrued liabilities 131,902 34,715 ( 1,481 )
Accrued interest, net of interest received on maturity of investments 5,971 ( 24,092 ) ( 5,450 )
Net cash used in operating activities ( 189,553 ) ( 455,572 ) ( 324,230 )
Cash flows from investing activities:
Purchases of marketable securities ( 1,047,510 ) ( 1,131,207 ) ( 834,439 )
Sales and maturities of marketable securities 1,083,297 863,283 333,398
Acquisition of intangible asset ( 3,000 ) ( 5,000 ) —
Purchases of property and equipment, net of disposals ( 467 ) ( 1,462 ) ( 1,479 )
Net cash provided by (used in) investing activities 32,320 ( 274,386 ) ( 502,520 )
Cash flows from financing activities:
Proceeds from issuances of stock, excluding related parties, net of transaction costs — 397,487 260,187
Proceeds from related parties - warrants, exercise of common stock options, net of transaction costs 38,055 337,575 270,292
Proceeds from issuance of debt 350,000 — 65,000
Payment of debt issuance costs ( 10,407 ) — ( 363 )
Repayment of debt
( 121,664 ) — —
Net cash provided by financing activities 255,984 735,062 595,116
Effect of exchange rate changes on cash, cash equivalents and restricted cash 13 — —
Net increase (decrease) in cash, cash equivalents, and restricted cash 98,764 5,104 ( 231,634 )
Cash, cash equivalents, and restricted cash at beginning of period 105,019 99,915 331,549
Cash, cash equivalents, and restricted cash at end of period $ 203,783 $ 105,019 $ 99,915
Supplemental disclosure of cash flow information:
Obtaining a right-of-use asset in exchange for a lease liability $ 3,982 $ 1,330 $ 1,628
See accompanying notes to consolidated financial statements.
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MADRIGAL PHARMACEUTICALS, INC.
Notes to Consolidated Financial Statements
1. Organization, Business and Basis of Presentation
Organization and Business
Madrigal Pharmaceuticals, Inc. (the “Company” or “Madrigal”) is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (“MASH”), a serious liver disease with high unmet medical need that can lead to cirrhosis, liver failure, liver cancer, need for liver transplantation and premature mortality. MASH was previously known as nonalcoholic steatohepatitis (“NASH”). MASH is the leading cause of liver transplantation in women, the second leading cause of all liver transplantation in the United States and the fastest-growing indication for liver transplantation in Europe. The Company’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed thyroid hormone receptor beta (“THR-β”) agonist designed to target key underlying causes of MASH. In March 2024, Rezdiffra became the first therapy approved by the U.S. Food and Drug Administration (“FDA”) for patients with MASH and was commercially available in the United States beginning in April 2024. Following receipt of conditional marketing authorization (“CMA”) from the European Commission (“EC”), the Company launched Rezdiffra in Germany in September 2025. Rezdiffra was the first medication approved by both the FDA and EC for the treatment of adults with noncirrhotic MASH with moderate to advanced liver fibrosis (F2 to F3 fibrosis). The Company is also evaluating Rezdiffra in patients with compensated MASH cirrhosis (consistent with F4c fibrosis) in its MAESTRO-NASH OUTCOMES trial, that, if successful, could expand the eligible patient population for Rezdiffra. In addition, the Company plans to evaluate its pipeline candidates with the goal of delivering best-in-disease therapies for the treatment of MASH.
Basis of Presentation
The accompanying consolidated financial statements have been prepared in conformity with generally accepted accounting principles in the United States of America (“U.S. GAAP”) and include accounts of the Company and its wholly-owned subsidiaries. Certain prior period amounts have been reclassified to align with current period presentation.
2. Summary of Significant Accounting Policies
Principle of Consolidation
The consolidated financial statements include the financial statements of the Company and its wholly owned subsidiaries. All significant intercompany balances and transactions have been eliminated in consolidation.
Use of Estimates
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect certain reported amounts of assets and liabilities, and the reported amounts of revenues and expenses during the reporting periods. The Company bases its estimates on historical experience and various other assumptions that management believes to be reasonable under the circumstances. Changes in estimates are recorded in the period in which they become known. Actual results could differ from those estimates.
Revenue Recognition
The Company recognizes revenue in accordance with ASC Topic 606 - Revenue from Contracts with Customers ("ASC 606"). Revenue is recognized at a point in time when the customer obtains control of promised goods or services in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligation(s) in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligation(s) in the contract; and (v) recognize revenue when (or as) the Company satisfies its performance obligation(s).
Product Revenue, Net
On March 14, 2024, the Company announced that the FDA granted accelerated approval of Rezdiffra (resmetirom) in conjunction with diet and exercise for the treatment of adults with noncirrhotic MASH with moderate to
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advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). The Company enters into agreements with specialty pharmacies and specialty distributors (each a “Customer” and collectively the “Customers”) to sell Rezdiffra in the U.S.. Revenues from product sales are recognized when the Customer obtains control of the Company’s product, which occurs at a point in time, typically upon delivery to the Customer.
Revenue is recorded net of variable consideration, which includes prompt pay discounts, returns, chargebacks, rebates and co-payment assistance. The variable consideration is estimated based on contractual terms as well as management assumptions and historical data. The amount of variable consideration is calculated by using the expected value method, which is the sum of probability-weighted amounts in a range of possible outcomes, or the most likely amount method, which is the single most likely amount in a range of possible outcomes. Estimates are reviewed quarterly and adjusted as necessary.
Accruals are established for gross to net deductions and actual amounts incurred are offset against applicable accruals. The Company reflects these accruals as either a reduction in the related account receivable from the customer or as a current liability, depending on the means by which the deduction is settled. Sales deductions are based on management’s estimates that involve a substantial degree of judgment.
Prompt Pay : Customers receive a prompt pay discount for payments made within a contractually agreed number of days before the due date. The discounts are accounted for as a reduction of the transaction price and recorded as a contra receivable.
Returns : The Company records allowances for product returns as a reduction of revenue at the time product sales are recorded. Product returns are estimated based on forecasted sales and historical and industry data. Returns are permitted in accordance with the return goods policy defined within each customer agreement. A returns reserve is recorded as an accrued liability.
Chargebacks : The Company estimates obligations resulting from contractual commitments with the government and other entities to sell products to qualified healthcare providers at prices lower than the list prices charged to the customer who directly purchases from the Company. The customer charges the Company for the difference between what it pays to the Company for the product and the selling price to the qualified healthcare providers, with the difference recorded as a contra receivable.
Co-Payment Assistance : Co-payment assistance programs are offered to eligible end-users as price concessions and are recorded as accrued liabilities and a reduction of the transaction price. The Company uses a third-party to administer the co-payment program for pharmacy benefit claims.
Rebates : The Company’s rebates include amounts paid to Medicaid, Medicare, certain other payors and other rebate programs. Reserves for rebates are recorded in the same period the related product revenue is recognized, resulting in a reduction of product revenues and a current liability that is included in accrued expenses on the consolidated balance sheet. The Company’s estimate for rebates is based on statutory or contractual discount rates, expected utilization or an estimated number of patients on treatment, as applicable.
Trade Receivables, Net
The Company’s trade receivables relate to amounts due from Customers related to product sales and are recorded net of prompt pay discounts and chargebacks. The Company assesses collectibility of overdue receivables and those determined to be uncollectible are written-off. As of December 31, 2025, there were no receivables written off.
Cash and Cash Equivalents
The Company considers all highly liquid debt instruments with an original maturity of three months or less to be cash equivalents. The carrying amount reported in the Company’s consolidated balance sheets for cash and cash equivalents approximates its fair value.
Marketable Securities
Marketable securities consist of available-for-sale debt securities that are presented as current assets in the Company’s consolidated balance sheets.
The Company adjusts the cost of available-for-sale debt securities for amortization of premiums and accretion of discounts to maturity. The Company includes such amortization and accretion as a component of interest income, net. Realized gains and losses and declines in value, if any, that the Company judges to be the result of impairment or as a result of recognizing an allowance for credit losses on available-for-sale securities are reported as a component of interest income. To determine whether an impairment exists, the Company considers whether it intends to sell the debt security and, if the Company does not intend to sell the debt security, it considers available evidence to assess whether it is more
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likely than not that it will be required to sell the security before the recovery of its amortized cost basis. During the years ended December 31, 2025, 2024 and 2023, the Company determined it did not have any securities that were other-than-temporarily impaired.
Marketable securities are stated at fair value, including accrued interest, with their unrealized gains and losses included as a component of accumulated other comprehensive income or loss, which is a separate component of stockholders’ equity. The fair value of these securities is based on quoted prices and observable inputs on a recurring basis. Realized gains and losses are determined on the specific identification method. During the years ended December 31, 2025, 2024 and 2023, realized gains and losses on marketable securities were not material to the consolidated financial statements.
Fair Value of Financial Instruments
The carrying amounts of the Company’s financial instruments, which include cash equivalents, and marketable securities, approximate their fair values. The fair value of the Company’s financial instruments reflects the amounts that would be received upon sale of an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. The fair value hierarchy has the following three levels:
Level 1—quoted prices in active markets for identical assets and liabilities.
Level 2—observable inputs other than Level 1 inputs. Examples of Level 2 inputs include quoted prices in active markets for similar assets or liabilities and quoted prices for identical assets or liabilities in markets that are not active.
Level 3—unobservable inputs that reflect the Company’s own assumptions about the assumptions market participants would use in pricing the asset or liability.
Financial assets and liabilities are classified in their entirety within the fair value hierarchy based on the lowest level of input that is significant to the fair value measurement. The Company measures the fair value of its marketable securities by taking into consideration valuations obtained from third-party pricing sources. The pricing services utilize industry standard valuation models, including both income and market-based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. These inputs include reported trades of and broker-dealer quotes on the same or similar securities, issuer credit spreads, benchmark securities and other observable inputs.
As of December 31, 2025 and 2024, the Company’s financial assets valued based on Level 1 inputs consisted of cash and cash equivalents in a money market fund, its financial assets valued based on Level 2 inputs consisted of high-grade corporate and government agency bonds and commercial paper, and it had no financial assets valued based on Level 3 inputs. During the years ended December 31, 2025, 2024 and 2023, the Company did not have any transfers of financials assets between Levels 1 and 2. As of December 31, 2025 and 2024, the Company did not have any financial liabilities that were recorded at fair value on a recurring basis on the balance sheet.
Inventory
Inventory, which consists of work in process and finished goods, is stated at the lower of cost or estimated net realizable value, using actual cost, based on a first-in, first-out method. The balance sheet classification of inventory as current or non-current is determined by whether it will be consumed within the Company’s normal operating cycle. The Company analyzes its inventory levels quarterly and writes down inventory subject to expiry or in excess of expected requirements, or that has a cost basis in excess of its expected net realizable value. These write downs are charged to cost of sales in the accompanying Consolidated Statements of Operations. The Company capitalizes inventory costs when future commercial sale in the ordinary course of business is probable.
The Company considered regulatory approval of its product candidate to be uncertain and product manufactured prior to regulatory approval could not have been sold unless regulatory approval was obtained. As such, the manufacturing costs incurred prior to regulatory approval were not capitalized as inventory, but rather were expensed as incurred as research and development expenses. The Company began capitalizing inventory in March 2024 after FDA approval was granted.
Research and Development Costs
Research and development costs are expensed as incurred. Research and development costs are comprised of costs incurred in performing research and development activities, including internal costs (including cash compensation and stock-based compensation), costs for consultants, milestone payments under licensing agreements, and other costs associated with the Company’s preclinical and clinical programs. In particular, the Company has conducted safety studies in animals, optimized and implemented the manufacturing of its drug, and conducted clinical trials, all of which are
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considered research and development expenditures. Management uses significant judgment in estimating the amount of research and development costs recognized in each reporting period. Management analyzes and estimates the progress of its clinical trials, completion of milestone events per underlying agreements, invoices received and contracted costs when estimating the research and development costs to accrue in each reporting period. Actual results could differ from the Company’s estimates.
Selling, General and Administrative Expenses
Selling, general and administrative expenses consist primarily of salaries, benefits and stock-based compensation expenses for employees, management costs, costs associated with obtaining and maintaining our patent portfolio, commercial and marketing activities, advertising, professional fees for accounting, auditing, consulting and legal services, and allocated overhead expenses.
Advertising costs are expensed as incurred. During the years ended December 31, 2025 and 2024, advertising costs were approximately $ 145.1 million and $ 52.7 million. The Company did not have any commercial products during the year ended December 31, 2023 and therefore no related advertising costs.
Leases
The Company determines if an arrangement is a lease at contract inception. All leases are classified as operating leases. Lease assets represent the right to use an underlying asset for the lease term and lease liabilities represent an obligation to make lease payments arising from the leasing arrangement. Operating lease assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. When an implicit rate is not readily determinable, an incremental borrowing rate is estimated based on information available at commencement. Lease expense is recognized on a straight-line basis over the lease term. Short-term leases of 12 months or less at commencement date are expensed as incurred.
Patents
Costs to secure and defend patents are expensed as incurred and are classified as selling, general and administrative expense in the Company’s statements of operations. Patent expenses were approximately $ 0.7 million, $ 0.7 million and $ 0.9 million for the years ended December 31, 2025, 2024 and 2023, respectively.
Intangible Assets, Net
Intangible assets with finite lives are amortized to cost of sales over their estimated useful lives using the straight-line method. Intangible assets are tested for recoverability whenever events or changes in circumstances indicate that the carrying amounts may not be recoverable.
Stock-Based Compensation
The Company recognizes stock-based compensation expense based on the grant date fair value of stock options, restricted stock units, and other stock-based compensation awards granted to employees, officers, directors, and consultants. Awards that vest as the recipient provides service are expensed on a straight-line basis over the requisite service period.
The Company uses the Black-Scholes option pricing model to determine the grant date fair value of stock options as management believes it is the most appropriate valuation method for its option grants. The Black-Scholes model requires inputs for risk-free interest rate, dividend yield, volatility and expected lives of the options. The expected lives for options granted represent the period of time that options granted are expected to be outstanding. The Company uses the simplified method for determining the expected lives of options. Expected volatility is based upon an industry estimate, the Company’s historical trading activity, or a blended rate of the two. The risk-free rate for periods within the expected life of the option is based on the U.S. Treasury yield curve in effect at the time of the grant. The Company estimates the forfeiture rate based on historical data. This analysis is re-evaluated at least annually and the forfeiture rate is adjusted as necessary.
For other stock-based compensation awards granted to employees and directors that vest based on market conditions, such as the trading price of the Company’s common stock achieving or exceeding certain price targets, the Company uses a Monte Carlo simulation model to estimate the grant date fair value and recognize stock compensation expense over the derived service period. The Monte Carlo simulation model requires key inputs for risk-free interest rate, dividend yield, volatility, and expected life.
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The assumptions used in computing the fair value of equity awards reflect the Company’s best estimates but involve uncertainties related to market and other conditions. Changes in any of these assumptions may materially affect the fair value of awards granted and the amount of stock-based compensation recognized.
Income Taxes
The Company accounts for income taxes in accordance with ASC 740, “Income Taxes”, which prescribes the use of the liability method where deferred tax asset and liability account balances are determined based on differences between financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. The Company provides a valuation allowance, if necessary, to reduce deferred tax assets to their estimated realizable value if it is more likely than not that a portion or all of the deferred tax assets will not be realized based on the weight of available positive and negative evidence. The Company currently maintains a 100 % valuation allowance on its deferred tax assets.
The Company recognizes the financial statement effects of a tax position when it is more likely than not (a likelihood of greater than 50%) that the position will be sustained upon examination by the relevant taxing authority, based on the technical merits of the position. Uncertain tax positions are recorded based upon certain recognition and measurement criteria. The Company re-evaluates uncertain tax positions at each reporting date and considers all available information, including, but not limited to, changes in tax laws or regulations, developments in case law, changes in the expected timing or outcome of audits, settlements with taxing authorities, and changes in facts or circumstances related to a particular tax position. Adjustments to recognized tax positions are recorded in the period in which new information becomes available. Interest and penalties related to unrecognized tax benefits are recognized as a component of income tax expense in the Consolidated Statements of Operations.
Comprehensive Income (Loss)
Comprehensive income (loss) is defined as the change in equity of a business enterprise during a period from transactions and other events and circumstances from non-owner sources. The difference between the Company’s net income (loss) and comprehensive income (loss) includes changes in unrealized gains and losses on marketable securities and foreign currency translation adjustments.
Basic and Diluted Loss Per Common Share
Basic net loss per share is computed using the weighted average number of common shares outstanding during the period. Diluted net loss per common share is computed using the weighted average number of common shares outstanding and the weighted average dilutive potential common shares outstanding using the treasury stock method. However, for the years ended December 31, 2025, 2024 and 2023, diluted net loss per share is the same as basic net loss per share because the inclusion of weighted average shares of common stock issuable upon the exercise of stock options and warrants or vesting of restricted stock units, and common stock issuable upon the conversion of preferred stock would be anti-dilutive.
The following table summarizes outstanding securities not included in the computation of diluted net loss per common share as their inclusion would be anti-dilutive:
As of December 31,
2025 2024 2023
Common stock options 979,861 1,528,143 2,355,779
Restricted stock units
798,422 499,559 376,117
Performance-based restricted stock units 256,488 235,520 150,000
Convertible preferred stock 2,369,797 2,369,797 2,369,797
Warrants 19,454 19,454 19,454
Pre-funded warrants
3,605,790 3,605,790 2,048,098
Recent Accounting Pronouncements
From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board ("FASB") or other standard setting bodies and adopted by the Company as of the specified effective date. Except as noted below, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on its condensed consolidated financial statements and disclosures.
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In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which enhances the disclosures required for income taxes in the Company’s annual consolidated financial statements. The amendments are effective for annual periods beginning after December 15, 2024. The Company adopted ASU 2023-09 prospectively, and the adoption impacted the Company’s income tax disclosures only and did not have an impact on its consolidated financial statements.
In November 2024, the FASB issued ASU 2024-03, Disaggregation of Income Statement Expenses ("DISE"), which applies to all public entities and requires disclosures about specific types of expenses included in the expense captions presented on the face of the income statement as well as disclosures about selling expenses. Public entities must adopt the new standard prospectively for fiscal years beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. Early adoption and retrospective application are permitted. The Company is currently evaluating the impact of ASU 2024-03 on its consolidated financial statements.
In September 2025, the FASB issued ASU 2025-06, Intangibles - Goodwill and Other - Internal-Use Software (Subtopic 350-40): Targeted Improvements to the Accounting for Internal-Use Software (“ASU 2025-06”), which clarifies and aligns existing guidance related to accounting for certain costs incurred in connection with internal-use software, including updated guidance regarding agile and iterative software development methodologies. The standard applies to all entities that incur costs to develop internal-use software. ASU 2025-06 is effective for annual periods beginning after December 15, 2027, and interim periods within those annual periods. Early adoption is permitted. The Company is currently evaluating the impact of ASU 2025-06 on its consolidated financial statements.
3. Liquidity and Uncertainties
The Company is subject to risks common to development stage companies and early commercial companies in the biopharmaceutical industry including, but not limited to, uncertainty of product development and commercialization, dependence on key personnel, uncertainty of market acceptance of products and product reimbursement, product liability, uncertain protection of proprietary technology, potential inability to raise additional financing necessary for development and commercialization, and compliance with applicable regulations.
The Company has incurred losses since inception, including $ 288.3 million for the year ended December 31, 2025, resulting in an accumulated deficit of $ 2,090.5 million and $ 1,802.2 million as of December 31, 2025 and 2024, respectively. The Company has historically funded its operations primarily through proceeds from sales of the Company’s capital stock and debt financings. In July 2025, the Company entered into a senior secured credit facility that provides up to $ 500.0 million. See Note 8 “Long Term Debt” for additional details. In addition, following FDA and EC approval, the Company receives revenue from sales of Rezdiffra. Management expects to incur losses until the Company is able to generate sufficient revenue from Rezdiffra and any other approved products. The Company believes that its cash, cash equivalents and marketable securities at December 31, 2025 will be sufficient to fund operations past one year from the issuance of these financial statements. The Company’s future long-term liquidity requirements will be substantial and will depend on many factors, including the Company’s ability to effectively commercialize Rezdiffra, the Company’s decisions regarding future geographic expansion, the conduct of any future preclinical studies and clinical trials, the Company entering into any strategic transactions, the Company’s ability to maintain compliance with the liquidity covenant in the Financing Agreement (as defined in Note 8) and potential milestone payments payable pursuant to its license agreements. To meet its future capital needs, the Company may need to raise additional capital through debt or equity financings, collaborations, partnerships or other strategic transactions. However, there can be no assurance that the Company will be able to complete any such transactions on acceptable terms or otherwise. The inability of the Company to obtain sufficient funds on acceptable terms when needed, if at all, could have a material adverse effect on the Company’s business, results of operations and financial condition. The Company has the ability to delay certain commercial activities, geographic expansion activities and certain research activities and related clinical expenses if necessary due to liquidity concerns until a date when those concerns are relieved.
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4. Product Revenue, Net
The following table summarizes balances and activity for gross to net reserves (in thousands):
Chargebacks, Discounts for Prompt Pay and Other Allowances Rebates, Customer Fees/Credits, Co-Pay Assistance, and Other Totals
Balance at December 31, 2023 $ — $ — $ —
Provision related to sales in the current year 8,045 35,115 43,160
Adjustments related to prior year sales — — —
Payments and customer credits issued ( 3,857 ) ( 13,412 ) ( 17,269 )
Balance at December 31, 2024 $ 4,188 $ 21,703 $ 25,891
Provision related to sales in the current year 36,640 208,462 245,102
Adjustments related to prior year sales ( 1,573 ) ( 4,655 ) ( 6,228 )
Payments and customer credits issued ( 30,417 ) ( 135,006 ) ( 165,423 )
Balance at December 31, 2025 $ 8,838 $ 90,504 $ 99,342
Concentrations of Credit Risk and Significant Customers
The Company generates revenue from a small number of large, reputable customers. The following customers accounted for over 10% of total gross product revenue during the year ended December 31, 2025 and the year ended December 31, 2024. Rezdiffra was first made commercially available in April 2024, and therefore there were no sales and no corresponding customer concentrations in 2023.
Year ended December 31,
2025 2024 2023
Customer A
34 % 39 % — %
Customer B
22 % 21 % — %
Customer C
15 % 14 % — %
Customer D
12 % 12 % — %
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5. Cash, Cash Equivalents, Restricted Cash, and Marketable Securities
The Company held restricted cash of $ 5.1 million and $ 5.0 million as of December 31, 2025 and 2024, respectively, predominately as collateral to its corporate credit card program. The Company did not have any restricted cash as of December 31, 2023.
A summary of cash, cash equivalents, restricted cash and available-for-sale marketable securities held by the Company as of December 31, 2025 and 2024 is as follows (in thousands):
December 31, 2025
Cost Unrealized
gains Unrealized
losses Fair
value
Cash and cash equivalents:
Cash (Level 1) $ 109,708 $ — $ — $ 109,708
Money market funds (Level 1) 50,211 — — 50,211
U.S. government and government-sponsored entity (GSE) securities (Level 1)
9,129 — — 9,129
Corporate debt securities with original maturities of 3 months or less (Level 2)
34,735 — — 34,735
Total cash and cash equivalents 203,783 — — 203,783
Marketable securities:
Corporate debt securities with original maturities of 1 year or less (Level 2) 372,096 178 ( 16 ) 372,258
U.S. government and GSE securities with original maturities of 1 year or less (Level 2)
298,007 460 ( 1 ) 298,466
U.S. government and GSE securities with original maturities of 1 to 2 years (Level 2)
91,936 211 — 92,147
Corporate debt securities with original maturities of 1 to 2 years (Level 2)
21,968 30 ( 3 ) 21,995
Total cash, cash equivalents, restricted cash, and marketable securities $ 987,790 $ 879 $ ( 20 ) $ 988,649
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December 31, 2024
Cost Unrealized
gains Unrealized
losses Fair
value
Cash and cash equivalents:
Cash (Level 1) $ 24,495 $ — $ — $ 24,495
Money market funds (Level 1) 65,302 — — 65,302
U.S. government and GSE securities (Level 1)
12,711 — — 12,711
Corporate debt securities with original maturities of 3 months or less (Level 2)
2,511 — — 2,511
Total cash and cash equivalents 105,019 — — 105,019
Marketable securities:
Corporate debt securities with original maturities of 1 year or less (Level 2) 367,950 190 ( 64 ) 368,076
U.S. government and GSE securities with original maturities of 1 year or less (Level 2)
382,793 279 ( 62 ) 383,010
U.S. government and GSE securities with original maturities of 1 to 2 years (Level 2)
71,739 156 ( 25 ) 71,870
Corporate debt securities with original maturities of 1 to 2 years (Level 2)
3,282 — ( 6 ) 3,276
Total cash, cash equivalents, restricted cash, and marketable securities $ 930,783 $ 625 $ ( 157 ) $ 931,251
6. Inventory
The following table summarizes the Company’s inventory balances as of December 31, 2025 and 2024 (in thousands):
December 31, 2025 December 31, 2024
Raw materials $ — $ —
Work in process 67,633 29,533
Finished goods 7,208 4,535
Total $ 74,841 $ 34,068
There was no provision for excess inventory recorded during the years ended December 31, 2025, 2024 or 2023.
7. Accrued Liabilities
Accrued liabilities as of December 31, 2025 and 2024 consisted of the following (in thousands):
December 31,
2025 December 31,
2024
Gross to net accrued expenses
$ 90,504 $ 21,703
Clinical study, manufacturing and drug supply
26,907 43,890
Compensation and benefits 69,211 34,209
Selling, general and administrative
40,026 18,257
Other 33,744 6,636
Total accrued liabilities $ 260,392 $ 124,695
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8. Long Term Debt
Hercules Loan Facility
In May 2022, the Company entered into a $ 250.0 million senior secured loan facility (as amended from time to time, the “Hercules Loan Facility”) with several banks and other financial institutions or entities party thereto (collectively, the “Hercules Lenders”), and Hercules Capital, Inc. (“Hercules”), in its capacity as administrative agent and collateral agent for itself and the Hercules Lenders. Interest on the Hercules Loan Facility was the greater of (i) the prime rate plus 2.45 % and (ii) 8.25 %. The Hercules Loan Facility included an end-of-term charge of 5.35 % of the aggregate principal amount, which was accounted for in the loan discount. In connection with the first tranche drawn at closing, the Company issued Hercules a warrant to purchase 14,899 shares of Company common stock, which had a Black-Scholes value of $ 0.6 million. In addition, the Company issued to Hercules and its affiliates warrants to purchase an aggregate of 4,555 shares of common stock, which had a Black-Scholes value of $ 0.9 million, following the closing of the second tranche.
On July 17, 2025, the Company used the proceeds of the Initial Term Loan under the Financing Agreement (each as defined below) to repay all outstanding obligations under the Hercules Loan Facility, totaling $ 121.7 million, and upon such repayment, terminated the Hercules Loan Facility. The amount repaid by the Company included $ 115.0 million of outstanding indebtedness plus accrued and unpaid interest as of the repayment date and exit fees. As a result of the termination, all credit commitments under the Hercules Loan Facility were terminated and all security interests and guarantees executed in connection with the Hercules Loan Facility were released. The repayment resulted in a $ 2.8 million loss on extinguishment of debt, primarily due to the write off of unamortized debt issuance costs.
Blue Owl Credit Facility
On July 17, 2025 (the “Closing Date”), the Company entered into a Financing Agreement (as amended from time to time, the “Financing Agreement”) with certain funds managed by Blue Owl Capital Corporation, as the lenders (the “Lenders”), and LSI Financing LLC, as the administrative agent for the Lenders (the “Administrative Agent”). Under the Financing Agreement, the Lenders have committed up to $ 500.0 million in senior secured credit facilities, consisting of (a) an initial term loan in an aggregate principal amount equal to $ 350.0 million (the “Initial Term Loan”) and (b) delayed draw term loan commitments in an aggregate principal amount not to exceed $ 150.0 million (the loans thereunder, if any, the “Delayed Draw Term Loans”). In addition, the Financing Agreement includes an uncommitted incremental facility in an aggregate principal amount not to exceed $ 250.0 million (the loans thereunder, if any, the “Incremental Term Loans”, together with the Initial Term Loan and any Delayed Draw Term Loans, collectively the “Term Loans”), subject to the satisfaction of certain terms and conditions set forth in the Financing Agreement. The Initial Term Loan was funded on the Closing Date. Delayed Draw Term Loans are available at the Company’s election from time to time after the Closing Date until December 31, 2027. Incremental Term Loans are available at the Company’s and the Lenders’ mutual consent from time to time after the Closing Date.
Any outstanding principal on the Term Loans will bear interest at a rate per annum on the basis of a 360-day year equal to the sum of (i) the three-month forward-looking term secured overnight financing rate administered by the Federal Reserve Bank of New York (subject to 1.0 % per annum floor) plus (ii) 4.75 %. Accrued interest is payable quarterly following the funding of the Initial Term Loan on the Closing Date, on any date of prepayment or repayment of the Term Loans and at maturity. The outstanding balance of the Term Loans, if not repaid sooner, shall be due and payable in full on the maturity date thereof. The stated maturity date of the Term Loans is July 17, 2030.
The Company may prepay the Term Loans at any time (in whole or in part) and may be required to make mandatory prepayments upon the occurrence of certain customary prepayment events. In certain instances and during certain time periods, these prepayments will be subject to customary prepayment fees. If the Term Loans are prepaid on or prior to the one-year anniversary of the original issuance, the Company must pay a make-whole amount equal to the greater of (i) 3.00 % of the Term Loans being prepaid at such time and (ii) the present value of all remaining interest payments on the amount repaid through the one-year anniversary of the original issuance of such Term Loans, calculated using a discount rate. Thereafter, the amount of any such prepayment fee may vary, but the maximum amount that may be due with any such prepayment would be an amount equal to 3.00 % of the Term Loans being prepaid at such time, with such prepayment fee stepping down on each anniversary of the original issuance of such Term Loans.
The Financing Agreement contains affirmative covenants and negative covenants applicable to the Company and its subsidiaries that are customary for financings of this type. The Company and the Guarantors (as defined below) are also required to maintain a minimum unrestricted cash balance of $ 100.0 million at all times. The Financing Agreement also includes representations, warranties, indemnities and events of default that are customary for financings of this type, including an event of default relating to a change of control of the Company. Upon the occurrence of an event of default,
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the Lenders may, among other things, accelerate the Company’s obligations under the Financing Agreement. The obligations of the Company under the Financing Agreement are and will be guaranteed by certain of the Company’s existing and future direct and indirect subsidiaries, subject to certain exceptions (such subsidiaries, collectively, the “Guarantors”).
On July 17, 2025, concurrently with the entry into the Financing Agreement, the Company and the Administrative Agent entered into a Pledge and Security Agreement. As security for the obligations of the Company and the Guarantors, each of the Company and the Guarantors are required to grant to the Administrative Agent, for the benefit of the Lenders and secured parties, a continuing first priority security interest in substantially all of the assets of the Company and the Guarantors (including all equity interests owned or hereafter acquired by the Company and the Guarantors), subject to certain customary exceptions. On September 4, 2025, the parties amended the Financing Agreement to add certain of the Company’s subsidiaries as Guarantors.
As of December 31, 2025, the outstanding principal under the Financing Agreement was $ 350.0 million. The interest rate as of December 31, 2025 was 8.75 %. As of December 31, 2025, the Company was in compliance with all loan covenants and provisions.
Future minimum payments, including interest and principal, under the loans payable outstanding as of December 31, 2025 are as follows (in thousands):
Period Ending December 31: Amount
2026 $ 29,886
2027 29,886
2028 29,968
2029 29,886
2030 366,212
$ 485,838
Less amount representing interest ( 135,838 )
Less unamortized discount ( 10,119 )
Loans payable, net of discount $ 339,881
9. Stockholders’ Equity
Common Stock
Each common stockholder is entitled to one vote for each share of common stock held. The common stock will vote together with all other classes and series of stock of the Company as a single class on all actions to be taken by the Company’s stockholders. Each share of common stock is entitled to receive dividends, as and when declared by the Company’s Board of Directors (the “Board”). The Company has never declared cash dividends on its common stock and does not expect to do so in the foreseeable future.
Preferred Stock
The Company’s Series A Preferred Stock and Series B Preferred Stock (together, the “Series A and B Preferred Stock”) have a par value of $ 0.0001 per share and are convertible into shares of the Company’s common stock at a one -to-one ratio, subject to adjustment as provided in the Certificates of Designation of Preferences, Rights and Limitations of Series A Preferred Stock and Series B Preferred Stock that the Company filed with the Secretary of State of the State of Delaware on June 21, 2017 and December 22, 2022, respectively. The terms of the Series A and B Preferred Stock are set forth in such Certificates of Designation. Each share of the Series A and B Preferred Stock is convertible into shares of common stock following notice that may be given at the holder’s option. Upon any liquidation, dissolution or winding-up of the Company, whether voluntary or involuntary, after the satisfaction in full of the debts of the Company and the payment of any liquidation preference owed to the holders of shares of capital stock of the Company ranking prior to the Series A and B Preferred Stock upon liquidation, the holders of the Series A and B Preferred Stock shall participate pari passu with the holders of the common stock (on an as-if-converted-to-common-stock basis) in the net assets of the Company. Shares of the Series A and B Preferred Stock will generally have no voting rights, except as required by law. Shares of the Series A and B Preferred Stock will be entitled to receive dividends before shares of any other class or series
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of capital stock of the Company (other than dividends in the form of the common stock) equal to the dividend payable on each share of the common stock, on an as-converted basis.
2024 Public Offering
On March 18, 2024, the Company entered into an Underwriting Agreement with Goldman Sachs & Co. LLC, Jefferies LLC, Cowen and Company, LLC, Evercore Group L.L.C. and Piper Sandler & Co, as representatives of the several underwriters named therein (the “2024 Underwriters”), pursuant to which the Company sold to the 2024 Underwriters in an underwritten public offering (the “2024 Offering”): (i) 750,000 shares of common stock at a public offering price of $ 260.00 per share, (ii) pre-funded warrants (the “2024 Pre-Funded Warrants”) to purchase 1,557,692 shares of common stock at a public offering price of $ 259.9999 per 2024 Pre-Funded Warrant, which represents the per share public offering price for the common stock less a $ 0.0001 per share exercise price for each such Pre-Funded Warrant, and (iii) a 30-day option for the 2024 Underwriters to purchase up to 346,153 additional shares of common stock at the public offering price of $ 260.00 per share (the “Underwriters’ Option”). The 2024 Offering closed on March 21, 2024. The gross proceeds of the 2024 Offering was $ 600.0 million, and the Company received net proceeds, after deducting the underwriting discount and commissions and other estimated offering expenses payable by the Company, of approximately $ 574.0 million.
The Underwriters’ Option was later exercised in full, and closed on April 2, 2024. The net proceeds to the Company for the exercise of the Underwriters’ Option, after deducting the underwriting discounts and commissions and estimated offering expenses payable by the Company, was approximately $ 85.9 million.
The 2024 Pre-Funded Warrants are exercisable at any time after the date of issuance. A holder of 2024 Pre-Funded Warrants may not exercise the warrant if the holder, together with its affiliates, would beneficially own more than 9.99 % of the number of shares of common stock outstanding immediately after giving effect to such exercise. A holder of 2024 Pre-Funded Warrants may increase or decrease this percentage, but not in excess of 19.99 %, by providing at least 61 days prior notice to the Company.
2023 Public Offering
On September 28, 2023, the Company entered into an Underwriting Agreement with Goldman Sachs & Co. LLC, as representative of the several underwriters named therein, pursuant to which the Company sold to the underwriters in an underwritten public offering (the “2023 Offering”): (i) 1,248,098 shares of common stock at a public offering price of $ 151.69 per share, and (ii) pre-funded warrants (the “Pre-Funded Warrants”) to purchase 2,048,098 shares of common stock at a public offering price of $ 151.6899 per Pre-Funded Warrant, which represents the per share public offering price for the common stock less a $ 0.0001 per share exercise price for each such Pre-Funded Warrant. The 2023 Offering closed on October 3, 2023.
The gross proceeds of the 2023 Offering was $ 500.0 million, and the Company received net proceeds, after deducting the underwriting discount and commissions and other estimated offering expenses payable by the Company, of approximately $ 472.0 million.
The 2023 Pre-Funded Warrants are exercisable at any time after the date of issuance. A holder of Pre-Funded Warrants may not exercise the warrant if the holder, together with its affiliates, would beneficially own more than 9.99 % of the number of shares of common stock outstanding immediately after giving effect to such exercise. A holder of Pre-Funded Warrants may increase or decrease this percentage, but not in excess of 19.99 %, by providing at least 61 days prior notice to the Company.
At-The-Market Issuance Sales Agreement
In May 2024, the Company entered into a Sales Agreement (the “Sales Agreement”) with Cowen and Company, LLC (“Cowen”). Pursuant to the Sales Agreement, the Company is authorized to issue and sell up to $ 300.0 million in shares of the Company’s common stock, at the Company’s option, through Cowen as its sales agent. Sales of common stock through Cowen could be made by any method that is deemed an “at-the-market” offering as defined in Rule 415 promulgated under the Securities Act of 1933, as amended, including by means of ordinary brokers’ transactions at market prices, in block transactions or as otherwise agreed by the Company and Cowen. Subject to the terms and conditions of the Sales Agreement, Cowen would use commercially reasonable efforts consistent with its normal trading and sales practices to sell the common stock based upon the Company’s instructions (including any price, time or size limits or other customary parameters or conditions the Company imposed). The Company sold no shares in the years ended December 31, 2025 or 2024 under the Sales Agreement.
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10. Stock-based Compensation
2015 Stock Plan
The 2015 Stock Plan, as amended (the “2015 Stock Plan”), is our shareholder-approved incentive plan through which equity based grants are awarded. The 2015 Stock Plan provides for the grant of incentive stock options, non-statutory stock options, restricted stock, restricted stock units and other stock-based compensation awards to employees, officers, directors, and consultants of the Company. The administration of the 2015 Stock Plan is under the general supervision of the Compensation Committee of the Board of Directors. The terms of stock options awarded under the 2015 Stock Plan, in general, are determined by the Compensation Committee, provided the exercise price per share generally shall not be set at less than the fair market value of a share of the common stock on the date of grant and the term shall not be greater than ten years from the date the option is granted. As of December 31, 2025, 654,994 shares were available for future issuance under the 2015 Stock Plan.
2023 Inducement Plan
In September 2023, the Company adopted the 2023 Inducement Plan (the “2023 Inducement Plan”), pursuant to which the Company from time to time was permitted to make equity grants to new employees as a material inducement to their employment. The 2023 Inducement Plan was adopted without stockholder approval, pursuant to Nasdaq Listing Rule 5635(c)(4), and was administered by the Compensation Committee of the Board. The 2023 Inducement Plan provided for the granting of non-statutory stock options, restricted stock, restricted stock units, performance stock units and other stock-based compensation awards to new employees, but did not allow for the granting of incentive stock options. The terms of the stock options under the 2023 Inducement Plan, in general, were determined by the Compensation Committee, provided the exercise price per share generally would not be set at less than the fair market value of a share of the common stock on the date of grant and the term would not be greater than ten years from the date the option or award was granted. A total of 500,000 shares of the Company’s common stock were reserved for issuance under the 2023 Inducement Plan. In June 2025, the Company terminated the 2023 Inducement Plan, and therefore no additional awards may be made from the 2023 Inducement Plan. Any awards outstanding under the 2023 Inducement Plan will continue to be governed by the terms thereof.
2025 Inducement Plan
In June 2025, the Company adopted the 2025 Inducement Plan (the “2025 Inducement Plan”), pursuant to which the Company may from time to time make equity grants to new employees as a material inducement to their employment. The 2025 Inducement Plan was adopted without stockholder approval, pursuant to Nasdaq Listing Rule 5635(c)(4), and is administered by the Compensation Committee of the Board. The 2025 Inducement Plan provides for the granting of non-statutory stock options, restricted stock, restricted stock units, performance stock units and other stock-based compensation awards to new employees, but does not allow for the granting of incentive stock options. The terms of the stock options under the 2025 Inducement Plan, in general, are determined by the Compensation Committee, provided the exercise price per share generally shall not be set at less than the fair market value of a share of the common stock on the date of grant and the term shall not be greater than ten years from the date the option or award is granted. A total of 100,000 shares of the Company’s common stock were initially reserved for issuance under the 2025 Inducement Plan. In September 2025, the 2025 Inducement Plan was amended to increase the aggregate number of shares reserved for issuance by an additional 300,000 shares. A total of 267,451 shares were available for future issuance as of December 31, 2025.
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Stock Options
The following table summarizes stock option activity during the year ended December 31, 2025:
Shares
Weighted
average exercise
price Weighted
average
remaining
contractual life
(years) Aggregate
intrinsic value
(in thousands)
Outstanding at December 31, 2024 1,528,143 $ 93.57
Options granted 145,219 340.27
Options exercised ( 681,134 ) 55.91
Options cancelled ( 12,367 ) 177.52
Outstanding at December 31, 2025 979,861 $ 155.25 5.19 $ 418,487
Exercisable at December 31, 2025 715,046 $ 112.02 4.28 $ 336,297
The total cash received by the Company as a result of stock option exercises was $ 38.1 million, $ 76.9 million and $ 34.0 million for the years ended December 31, 2025, 2024, and 2023. The total intrinsic value of options exercised was $ 227.5 million, $ 167.8 million, and $ 70.4 million for the years ended December 31, 2025, 2024, and 2023. The weighted-average grant date fair values, based on the Black-Scholes option model, of options granted during the year ended December 31, 2025, 2024 and 2023 was $ 200.55 , $ 155.42 , and $ 149.15 , respectively.
The following table summarizes the weighted average values of the assumptions used in computing the fair value of option grants during 2025, 2024, and 2023.
2025 2024 2023
Risk-free interest rate
4.1 % 4.1 % 4.4 %
Expected dividend yield
— % — % — %
Expected option life
6.2 years 4.7 years 6.3 years
Expected volatility
58 % 82 % 92 %
Restricted Stock Units
The Company awards restricted stock units (“RSUs”) to employees, officers, directors and consultants to the Company. RSUs vest over a period of years and are subject to forfeiture if employment or service terminates before vesting.
The following table summarizes RSU activity, excluding performance-based RSUs, during the year ended December 31, 2025:
Shares Weighted
average grant date fair value
Outstanding at December 31, 2024 499,559 $ 237.07
RSUs granted
491,079 357.36
RSUs vested
( 151,464 ) 239.43
RSUs forfeited
( 40,752 ) 291.04
Outstanding at December 31, 2025 798,422 $ 307.85
For the years ended December 31, 2025 and 2024 the total fair value of RSUs vested was $ 54.3 million, $ 28.9 million, respectively. For the year ended December 31, 2023 the fair value of RSUs vested was immaterial . For the years
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ended December 31, 2025, 2024, and 2023, the weighted-average grant date fair value of RSUs granted was $ 357.36 , $ 236.90 , and $ 243.81 , respectively.
Performance-Based Restricted Stock Units
The Company has granted various performance-based restricted stock units (“PSUs”) to certain senior leadership. Depending on the terms of the PSUs and the outcome of the pre-established performance criteria, which may include a market and/or performance condition, a recipient may ultimately earn the target number of PSUs granted or a specified multiple thereof at the end of the vesting period.
The following table summarizes PSU activity during the year ended December 31, 2025:
PSUs Eligible to Earn PSUs Weighted average grant date fair value
Outstanding PSUs at December 31, 2024 92,760 235,520 $ 257.77
PSUs granted 61,717 123,434 580.38
PSUs attained ( 50,000 ) ( 100,000 ) 146.37
PSUs forfeited ( 1,233 ) ( 2,466 ) 593.93
Outstanding at December 31, 2025 103,244 256,488 $ 500.55
Exercisable at December 31, 2025 — — $ —
For the years ended December 31, 2025, 2024, and 2023, the weighted average grant date fair value of PSUs granted was $ 580.38 , $ 388.02 , and $ 146.37 , respectively.
Outstanding Awards
As of December 31, 2025, the Company had RSUs, PSUs and options outstanding pursuant to which an aggregate of 2,034,771 shares of its common stock may be issued pursuant to the terms of all awards granted under the 2015 Stock Plan, 2023 Inducement Plan and 2025 Inducement Plan.
Stock-Based Compensation Expense
Stock-based compensation expense during the years ended December 31, 2025, 2024 and 2023 was as follows (in thousands):
Year Ended December 31,
2025 2024 2023
Stock-based compensation expense by type of award:
Stock options $ 21,328 $ 26,977 $ 30,613
Restricted stock units
58,610 35,136 14,974
Performance-based restricted stock units
18,192 17,767 4,148
Total stock-based compensation expense $ 98,130 $ 79,880 $ 49,735
Effect of stock-based compensation expense by line item:
Research and development $ 22,147 $ 22,158 $ 20,864
Selling, general and administrative 75,983 57,722 28,871
Total stock-based compensation expense included in net loss $ 98,130 $ 79,880 $ 49,735
Unrecognized stock-based compensation expense as of December 31, 2025 was $ 238.8 million with a weighted average remaining period of 2.81 years.
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11. Leases
In 2019, the Company entered into an operating lease for office space located in West Conshohocken, Pennsylvania (the “Office Lease”), which was further amended by four amendments entered into from 2019 to May 2023. In August 2023, the Company entered into the Fifth Amendment to the Office Lease (the “Fifth Lease Amendment”). The Fifth Lease Amendment extended the term of the Office Lease through November 2026. As a result of the Fifth Lease Amendment, an incremental $ 1.6 million right-of-use asset and lease liabilities were recorded during the year ended December 31, 2023. In 2024, the Company entered into the Sixth, Seventh, Eighth, and Ninth Amendments to the Office Lease, leasing additional office space available in the same premises under the Office Lease, which resulted in an incremental $ 1.3 million right-of-use asset and lease liability recorded.
In April 2025, the Company entered into an operating lease for additional office space in West Conshohocken, Pennsylvania. The lease commenced in May 2025 and resulted in a $ 4.0 million right-of-use asset and lease liability.
In September 2025, the Company entered into an operating lease for office space in Waltham, Massachusetts. The commencement date did not occur as of December 31, 2025 and therefore the new lease had no impact on the financial statements.
Future minimum payments under the Company’s operating leases related to the ROU asset and lease liability as of December 31, 2025 was as follows (in thousands):
Operating
Leases
2026 $ 1,242
2027 2,065
2028 2,102
2029 2,140
2030 2,178
Thereafter
555
Total minimum payments $ 10,282
Less: imputed interest ( 2,533 )
Present value of lease liabilities $ 7,749
As of December 31, 2025, the weighted average remaining operating lease term was 3.6 years and the weighted average discount rate used to determine the operating lease liabilities was 10.04 %. Cash paid related to lease liabilities was $ 1.4 million for the year ended December 31, 2025 and $ 1.1 million for the years ended December 31, 2024 and 2023, respectively. Operating lease costs were $ 1.9 million, $ 0.9 million and $ 1.1 million for the years ended December 31, 2025, 2024 and 2023, respectively. Rent, short term and variable lease costs were immaterial during the years ended December 31, 2025, 2024 and 2023.
12. Commitments and Contingencies
Licenses and Other Commitments
The Company has entered into customary contractual arrangements and letters of intent in preparation for and in support of operations in the normal course of business. As of December 31, 2025, the Company had approximately $ 268.3 million of obligations under these agreements related to active pharmaceutical ingredient, which is expected to be paid through 2029.
Roche Agreement
The Company has a Research, Development and Commercialization Agreement (as amended, the “Roche Agreement”) with Hoffmann-La Roche (“Roche”) which grants the Company a sole and exclusive license to develop, use, sell, offer for sale and import any Licensed Product (as defined in the Roche Agreement). In January 2026, the Company entered into an amendment to the Roche Agreement to provide the Company the full and exclusive right and discretion to control all patent term adjustments and patent term extensions applicable to Rezdiffra, including patents owned by Roche and jointly owned between the parties. In consideration of the foregoing, the royalty payable to Roche based on net sales of
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Rezdiffra will not be reduced until the expiration of certain patent term extensions that have been, or could have been, filed.
The Roche Agreement required certain milestone payments to Roche. In March 2024, upon receiving FDA approval of Rezdiffra, a milestone was achieved and $ 5.0 million was paid to Roche. In August 2025, upon receiving conditional marketing authorization from the EC, a milestone was achieved and $ 3.0 million was paid to Roche. Furthermore, a tiered single-digit royalty is payable on net sales of resmetirom or a product developed from resmetirom, subject to certain reductions. The Company began incurring royalty expense following its commercial launch of Rezdiffra in April 2024.
CSPC License (MGL-2086)
In July 2025, the Company entered into an exclusive global license agreement (the “CSPC License Agreement”) with CSPC Pharmaceutical Group Limited (“CSPC”) for MGL-2086 (formerly known as SYH2086), an oral small molecule GLP-1 receptor agonist. Pursuant to the CSPC License Agreement, CSPC has granted the Company an exclusive global license to develop, manufacture, and commercialize MGL-2086. The transaction closed in September 2025. The Company paid CSPC an upfront payment of $ 120.0 million in October 2025. CSPC is eligible to receive up to $ 2.0 billion in development, regulatory and commercial milestone payments, as well as royalties on net sales ranging from mid-single digits to low-double digits.
Pfizer License (ervogastat)
In December 2025, the Company entered into an exclusive global license agreement with Pfizer (the “Pfizer License Agreement”) to develop, manufacture and commercialize ervogastat, a Phase 2 oral DGAT-2 inhibitor, and two additional early-stage MASH assets. The Company paid Pfizer an upfront payment of $ 50.0 million in December 2025. In addition, Pfizer is eligible to receive up to $ 70.0 million in development and regulatory milestone payments related to ervogastat and low-double digit royalties on net sales of ervogastat. Pfizer is eligible to receive additional development, regulatory and commercial milestone payments and royalty payments on net sales of the two licensed early stage assets.
Ribocure License (siRNA programs)
In February 2026, the Company entered into an exclusive global license agreement (the “Ribocure License Agreement”) with Suzhou Ribo Life Science Co. Ltd. and Ribocure Pharmaceuticals AB (together, “Ribocure”) granting the Company exclusive global rights to develop, manufacture and commercialize six siRNA programs. Pursuant to the Ribocure License Agreement, the Company will pay Ribocure an upfront payment of $ 60.0 million. In addition, Ribocure is eligible to receive up to $ 4.4 billion in development, regulatory and commercial milestone payments across all programs, as well as royalties on net sales ranging from mid-single digits to low-double digits.
13. Income Taxes
The Company is subject to U.S. federal, state, and foreign income taxes. For the years ended December 31, 2025, 2024, and 2023, the components of loss before provision for income taxes consisted of $ 158.5 million, $ 465.9 million, and $ 373.6 million, respectively, for the United States and $ 129.8 million for foreign in 2025. The Company did not have any foreign operations in 2024 or 2023.
As of December 31, 2025, the Company had federal net operating loss (“NOL”) carryforwards of approximately $ 1,179.0 million available to reduce future taxable income, of which $ 40.4 million will expire between 2031 and 2037. In addition, the Company had foreign NOL carryforwards of approximately $ 130.8 million available to reduce future taxable income, which will begin to expire in 2033. The Company also had state NOL carryforwards of approximately $ 979.5 million available to reduce future taxable income, which expire between 2031 and 2043. In addition, the Company had unused federal and state research and development tax credit carryforwards of approximately $ 81.6 million.
Under Section 382 of the Internal Revenue Code (“IRC”), the utilization of NOL carryforwards may be limited in the event of certain cumulative changes in ownership over a three-year period. Such an ownership change could limit the Company’s ability to utilize its NOL carryforwards and could be triggered by future issuances or sales of securities by the Company or its stockholders. The Company has determined that an ownership change occurred during the year ended December 31, 2017. As a result, the Company’s NOL carryforwards are estimated to be subject to an annual limitation; however, none of the NOLs are expected to expire before becoming available to reduce future taxable income.
In assessing the realizability of deferred tax assets, management considers whether it is more likely than not that some portion of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible.
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As there is no assurance of future taxable income, a full valuation allowance has been established to offset the deferred tax assets. The valuation allowance increased $ 82.2 million for the year ended December 31, 2025. Changes in the deferred tax asset will be recorded as an income tax benefit or expense on the accompanying consolidated statements of operations.
Entities are also required to evaluate, measure, recognize and disclose any uncertain income tax provisions taken on their income tax returns. The Company has analyzed its tax positions and determined that it had net liabilities for uncertain tax positions, including accrued interest and penalties, of $ 12.1 million as of December 31, 2025. There were no uncertain tax positions as of December 31, 2024. Of the liabilities for uncertain tax positions as of December 31, 2025, none would impact the Company’s effective tax rate if recognized. The Company does not reasonably expect any material changes to the estimated liability associated with its uncertain tax positions in the next twelve months. Interest and penalties, if any, as they relate to income taxes assessed, are included in the income tax provision. There were no income tax related interest and penalties included in the income tax provision for 2025.
Unrecognized tax benefits were as follows (in thousands):
For the years ended December 31,
2025 2024 2023
Balance at beginning of period
$ — $ — $ —
Increases related to current period tax positions
3,160 — —
Increases related to prior period tax positions
8,898 — —
Balance at end of period
$ 12,058 $ — $ —
The Company files U.S. federal income tax returns and income tax returns in various state, local, and foreign jurisdictions and is routinely subject to examination by taxing authorities in those jurisdictions. Tax years beginning in 2021 remain open to examination by the Internal Revenue Service (“IRS”), state, and foreign taxing authorities. To the extent that the Company has tax attribute carryforwards, the tax years in which the attribute was generated may still be adjusted upon IRS, state, or foreign tax authorities’ examination to the extent utilized in a future period.
Temporary differences that give rise to deferred tax assets and liabilities are as follows (in thousands):
For the years ended December 31,
2025 2024 2023
Deferred tax liabilities
Unrealized gains on investments $ 117 $ 117 $ 117
Other deferred tax liabilities — 100 —
Property, plant & equipment
245 — —
Total deferred tax liabilities $ 362 $ 217 $ 117
Deferred tax assets
Accrued expenses 14,958 8,082 3,857
Intangibles 40,777 401 503
Gross to net accruals 3,462 167 —
Stock compensation 21,940 16,342 33,976
Property, plant & equipment — 172 95
Net operating losses and other carryforwards 318,121 214,464 121,589
Capitalized R&D 120,932 200,199 175,145
Other deferred tax assets
2,192 — —
R&D credit 69,029 69,201 48,074
Total deferred tax assets before valuation allowance 591,411 509,028 383,239
Valuation allowance ( 591,049 ) ( 508,811 ) ( 383,122 )
Total deferred tax assets 362 217 117
Net deferred tax assets $ — $ — $ —
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A reconciliation of the U.S. federal statutory tax rate to the Company’s effective tax rate for the year ended December 31, 2025 is as follows (in thousands, except percent):
For the year ended December 31, 2025
Amount Percent
Tax benefit at U.S. federal statutory rate $ ( 60,352 ) 21.0 %
State and local income taxes, net of federal income tax effect
— —
Foreign tax effects
Switzerland
Statutory tax rate difference between Switzerland & United States
17,227 ( 6.0 )
Change in valuation allowance
10,242 ( 3.6 )
Other foreign jurisdictions
95 —
Tax credits
( 11,886 ) 4.1
Change in valuation allowance
64,331 ( 22.4 )
Nontaxable or nondeductible items
Stock based compensation ( 44,008 ) 15.3
162M limitation 9,755 ( 3.4 )
Change in unrecognized Tax Benefits
12,058 ( 4.2 )
Other adjustments 2,538 ( 0.9 )
Income tax expense (benefit) and effective tax rate $ — — %
A reconciliation of the U.S. federal statutory tax rate to the Company’s effective tax rate for the years ended December 31, 2024 and 2023 is as follows (in thousands):
For the years ended December 31,
2024 2023
Tax benefit at U.S. federal statutory rate $ ( 97,837 ) $ ( 78,462 )
Stock-based compensation
( 9,954 ) ( 8,287 )
162M limitation
21,627 3,183
Other nondeductible expenses
835 53
State income tax benefit before valuation allowance, net of federal benefit
( 19,280 ) ( 16,246 )
Increase in domestic valuation allowance
125,689 112,606
Research and development credit
( 17,679 ) ( 12,971 )
Other adjustments ( 3,401 ) 124
Income tax expense (benefit) $ — $ —
14. Segment Information
The Company operates as one reportable segment focused on delivering novel therapeutics for MASH. The Company’s Chief Executive Officer, as the chief operating decision maker ("CODM"), leads the Company in support of four core values—focus on the patient, having an owner mindset, the relentless pursuit of innovation and commitment to collaboration. To best align the Company with these values, the CODM reviews consolidated financials, along with qualitative information, to evaluate performance, manage and allocate resources, make operating decisions, and assess planning and forecasting on a total company basis. Assets, liabilities and equity are reviewed and presented on the same level as the Company’s consolidated balance sheet.
Management does not segment business operations for internal reporting or decision making purposes. As the Company has a single reporting segment, the segment accounting policies are the same as those at the Company level, as
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described in Note 2 "Summary of Significant Accounting Policies." As of December 31, 2025, the Company did not have material revenue or assets outside of the United States.
The following table presents net income reported at the segment measure of profit and loss:
Year Ended December 31,
2025 2024 2023
Product revenue, net $ 958,403 $ 180,133 $ —
Cost of sales ( 56,148 ) ( 6,233 ) —
Research and development - personnel and internal expense ( 73,283 ) ( 73,418 ) ( 56,824 )
Research and development - external expense ( 315,242 ) ( 163,300 ) ( 215,526 )
Selling, general and administrative ( 813,827 ) ( 435,057 ) ( 108,146 )
Other segment income (1)
11,813 31,983 6,866
Net loss $ ( 288,284 ) $ ( 465,892 ) $ ( 373,630 )
(1) Other segment income includes interest income, interest expense, loss on extinguishment of debt and other expense, net.
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