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Item 9A. Controls and Procedures

2026-02-19 compared with 2025-02-21 · 296 added, 586 removed, 1260 unchanged (41% of the section changed)

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and subsidiaries (the Company) maintained, in all material respects, effective internal control over financial reporting as of December 31, 2025, based on the COSO criteria.

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance sheets of the Company as of December 31, 2024 and 2023, the related consolidated statements of operations and comprehensive loss, stockholders’ equity and cash flows for each of the two years in the period ended December 31, 2024 and the related notes and our report dated February 20, 2025 expressed an unqualified opinion thereon.

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance sheets of the Company as of December 31, 2025 and 2024, the related consolidated statements of operations and comprehensive loss, stockholders’ equity and cash flows for each of the three years in the period ended December 31, 2025 and the related notes and our report dated February 19, 2026 expressed an unqualified opinion thereon.

Basis for Opinion

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Trading Arrangements

During the fiscal quarter ended December 31, 2024, our directors and/or officers (as defined in Rule 16a-1(f) under the Exchange Act) adopted , modified or terminated the “Rule 10b5-1 trading arrangements” or “non-Rule 10b5-1 trading arrangements,” as those terms are defined in Regulation S-K, Item 408, set forth below:

During the fiscal quarter ended December 31, 2025, certain of our directors and/or officers (as defined in Rule 16a-1(f) under the Exchange Act) adopted or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as those terms are defined in Regulation S-K, Item 408, as set forth below.

Each 10b5-1 plan listed below is part of such individual’s long-term asset diversification, tax and/or financial planning strategy, and has been entered into in accordance with the terms of our Insider Trading Policy.

Under the terms of the plans, once the plans are in effect, the individuals listed below have no discretion or control over the timing or effectuation of any transactions in our securities pursuant to the plans, and sales will be made only if the stock meets the minimum price thresholds and/or other requirements specified in the applicable plan.

Some of the planned sales relate to shares required to be sold by such individual to cover the tax withholding obligation in connection with the settlement of vested restricted stock units and/or performance restricted stock units.

Each such director and/or officer continues to be subject to our stock ownership guidelines, and the execution of all potential sales under the plan would not by themselves cause any such individual to be out of compliance with the requirements of our stock ownership guidelines.

Trading Arrangements Adopted:

Name & Title Date Adopted Character of Trading Arrangement (1) Aggregate Number of Shares of Common Stock to be Sold Pursuant to Trading Arrangement Expiration Date (2)

member of our Board of Directors

November 17, 2025 Rule 10b5-1 Trading Arrangement Up to 61,500 shares (3)

November 13, 2026

Timothy Coughlin ,

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November 19, 2025 Rule 10b5-1 Trading Arrangement Up to 13,250 shares (3)

March 31, 2025

February 25, 2027

chair of our Board of Directors

December 17, 2024 Rule 10b5-1 Trading Arrangement Up to 8,000 shares (4)

November 11, 2025 Rule 10b5-1 Trading Arrangement Up to 8,000 shares (4)

Jeffrey Meckler ,

member of our Board of Directors

December 17, 2024 Rule 10b5-1 Trading Arrangement Up to 8,000 shares (4)

November 17, 2025 Rule 10b5-1 Trading Arrangement Up to 8,000 shares (4)

1 Each trading arrangement marked as a “Rule 10b5-1 Trading Arrangement” is intended to satisfy the affirmative defense of Rule 10b5-1(c) under the Exchange Act (the “Rule”).

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Each trading arrangement marked as a “Rule 10b5-1 Trading Arrangement” only permits transactions upon expiration of the applicable mandatory cooling-off period under the Rule.

3 Consists of shares of underlying stock options expiring in March 2025.

4 Consists of shares of underlying stock options expiring in June 2025.

Trading Arrangements Modified or Terminated:

3 Includes shares underlying stock options expiring in May 2028.

4 Consists of shares of underlying stock options expiring in May 2026.

Trading Arrangements Terminated:

DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS

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DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

Information required by this item and not included below will be contained under the captions "Election of Directors" and "Information Regarding the Board of Directors and Corporate Governance", in our Definitive Proxy Statement for our 2025 Annual Meeting of Stockholders, to be filed pursuant to Regulation 14A with the Securities and Exchange Commission within 120 days of December 31, 2024 (the "Proxy Statement").

Information required by this item and not included below will be contained under the captions "Election of Directors", "Information Regarding the Board of Directors and Corporate Governance" and "Executive Officers," in our Definitive Proxy Statement for our 2026 Annual Meeting of Stockholders, to be filed pursuant to Regulation 14A with the Securities and Exchange Commission within 120 days of December 31, 2025 (the "Proxy Statement").

Such information is incorporated herein by reference.

Our Board of Directors consists of the following members:

Baynes, M.D., Ph.D.

has served as a director of the Company since June 2016.

Since July 2022, Dr.

Baynes has served as Executive Vice President and Chief Medical Officer of Eikon Therapeutics, Inc., a privately-held biotechnology company.

Prior to Eikon Therapeutics, Inc., until April 2022 he served as Senior Vice President and Head of Global Clinical Development at Merck Research Laboratories, the research division of Merck and Co., Inc., commencing in December 2013 and as Chief Medical Officer of Merck and Co, Inc., a global healthcare company, commencing in July 2016.

Prior to his roles at Merck, Dr.

Baynes served as Senior Vice President of Oncology, Inflammation and Respiratory Therapeutics at Gilead Sciences, Inc., a biopharmaceutical company, from January 2012 to December 2013.

Prior to Gilead, Dr.

Baynes held positions of increasing responsibility at Amgen Inc., a biotechnology company, including Vice President of Global Clinical Development and Therapeutic Area Head for Hematology/Oncology.

Before joining Amgen, Dr.

Baynes was the Charles Martin Professor of Cancer Research at the Barbara Ann Karmanos Cancer Institute, a National Cancer Institute-designated Comprehensive Cancer Center, at Wayne State University.

Baynes has authored more than 150 publications and is a member or fellow of several international medical societies.

Baynes currently serves on the Board of Directors of Natera, Inc., a genetic testing and diagnostics company, and on the Board of Directors of Aardvark Therapeutics, Inc., a biopharmaceutical company.

Baynes also currently serves on the Board of Directors of CatalYm GmbH, a privately-held Germany based biotechnology company, and on the Board of Directors of Adcendo, a privately held Denmark based biotechnology company.

Previously he served on the Board of Directors of Atara Biotherapeutics, Inc., a T-cell immunotherapy company.

Baynes received his medical degree and doctorate in philosophy from the University of the Witwatersrand in South Africa, and completed his medical training in the Department of Hematology and Oncology at Johannesburg Hospital.

Suzanne Bruhn, Ph.D.

has served as a director of the Company since April 2020.

Since November 2023, Dr.

Bruhn has served as Chief Executive Officer of The Charcot-Marie-Tooth Association (CMTA), a nonprofit patient advocacy organization dedicated to finding a cure for CMT, a rare, debilitating peripheral neuropathy.

Previously, from May 2019 to December 2023, Dr.

Bruhn served as the President and Chief Executive Officer of Tiaki Therapeutics Inc., a biotechnology company.

Bruhn served as President and Chief Executive Officer of Proclara Biosciences, Inc., a biotechnology company, from April 2017 to September 2018, and as President and Chief Executive Officer of Promedior, Inc., a biotechnology company, from May 2012 to November 2015.

Currently, Dr.

Bruhn serves on the Boards of Directors of Pliant Therapeutics, Inc., Vigil Neuroscience, Inc., and Mind Medicine Inc.

Previously, Dr.

Bruhn served as a member of the Board of Directors of Raptor Pharmaceuticals Corp., a pharmaceutical company, from April 2011 until it was acquired by Horizon Pharma plc in October 2016, as a member of the Board of Directors of Novelion Therapeutics, Inc., a biopharmaceutical company, from October 2017 to January 2020, as a member of the Board of Directors of Aeglea BioTherapeutics, Inc., a clinical stage biotechnology company, from February 2017 to August 2020, and on the Board of Directors of Avalo Therapeutics, Inc.

(formerly Cerecor, Inc.), a biopharmaceutical company from April 2020 to November 2021.

Earlier in her career Dr.

Bruhn served in roles of increasing responsibility at Shire Human Genetic Therapies (formerly Transkaryotic Therapies), including Senior Vice President, Strategic Planning and Program Management.

Bruhn received her B.S.

degree in Chemistry from Iowa State University and her Ph.D.

in Chemistry from Massachusetts Institute of Technology.

Timothy Coughlin has served as a director of the Company since March 2015.

Coughlin is the former Chief Financial Officer of Neurocrine Biosciences, Inc., a biopharmaceutical company that received FDA approval for INGREZZA® (valbenazine) and ORILISSA® (elagolix), both of which were discovered, developed and commercially launched during his tenure at Neurocrine from 2002 to 2018.

Coughlin currently serves on the board of directors of Fate Therapeutics, Inc., and as the Chair of the Board of Directors of aTyr Pharma, Inc., both biotechnology companies, and previously served on the Board of Directors of Peloton Therapeutics, Inc.

prior to its sale to Merck in 2019.

Prior to joining Neurocrine, he was with Catholic Health Initiatives, a nationwide integrated healthcare delivery system, where he served as Vice President, Financial Services.

Earlier in his career Mr.

Coughlin served as a Senior Manager in the Health Sciences practice of Ernst & Young LLP and its predecessors.

Coughlin holds a master's degree in international business from San Diego State University and a bachelor’s degree in accounting from Temple University.

Coughlin is a certified public accountant in both California and Pennsylvania.

Eric Dube, Ph.D.

has served as President and Chief Executive Officer of the Company and as a member of our board of directors since January 2019.

Previously, Dr.

Dube served as the Head of North America of ViiV Healthcare Limited, a pharmaceuticals company, since January 2018.

From June 2015 to December 2017, Dr.

Dube served as Sr.

Vice President and Head, Global Respiratory Franchise, of GlaxoSmithKline Pharmaceuticals plc (“GSK”), a pharmaceutical company.

From February 2013 to May 2015, Dr.

Dube served as Senior Vice President and Business Unit Head, Respiratory Japan of GSK.

Earlier in his career, Dr.

Dube held positions of increasing responsibility at GSK including senior

leadership roles in Strategy, Planning & Operations, Oncology, Managed Markets and Marketing.

Dube currently serves on the Board of Directors for the Biotechnology Innovation Organization (BIO).

Previously, Dr.

Dube served on the Board of Trustees for AIDS United, on the Board of Directors for Biocom California, and on the Board of Directors for Reneo Pharmaceuticals, Inc.

Dube holds a B.S.

from Santa Clara University and a M.A.

from Cornell University.

Gary Lyons has served as a director of the Company since October 2014 and Chair of the Company since May 2016.

Lyons was the founding President and Chief Executive Officer of Neurocrine Biosciences, Inc.

and he remains a member of its Board of Directors.

Prior to joining Neurocrine, Mr.

Lyons held a number of senior management positions at Genentech, Inc., including Vice President of Business Development and Vice President of Sales.

Previously, Mr.

Lyons served on the Board of Directors of Eledon Pharmaceuticals, Inc.

(formerly Novus Therapeutics, Inc.), from May 2017 to June 2023, on the Board of Directors of Fresh Tracks Therapeutics, Inc.

(formerly known as Brickell Biotech, Inc.) from August 2019 to September 2023 and on the Board or Directors of Rigel Pharmaceuticals, Inc.

from October 2005 to May 2024.

Lyons is also a Senior Advisor for HealthCare Royalty Partners.

Lyons holds a B.A.

in Marine Biology from the University of New Hampshire and an M.B.A.

from Northwestern University’s J.L.

Kellogg Graduate School of Management.

Jeffrey Meckler has served as a director of the Company since October 2014.

Since August 2021, Mr.

Meckler has served as Chief Executive Officer of Indaptus Therapeutics, Inc.

(formerly Intec Inc.), a biopharmaceutical company.

From April 2017 to August 2021, Mr.

Meckler served as Chief Executive Officer and Vice Chair of the Board of Intec Pharma, Ltd.

He served as Chief Executive Officer and a director of Cocrystal Pharma, Inc., a pharmaceutical company, from April 2015 to July 2016, as a director of QLT, Inc., an ultra-orphan ophthalmic biotechnology company based in Canada, from June 2012 to November 2016, as well as the Managing Director of The Andra Group, a life sciences consulting firm.

Previously, Mr.

Meckler acted as a director of several biopharmaceutical companies and medical device companies.

Earlier in his career, Mr.

Meckler held a series of positions at Pfizer Inc.

in Manufacturing Systems, Market Research, Business Development, Strategic Planning and Corporate Finance, which included playing a significant role in acquisitions and divestitures.

Meckler is the past President and continues to serve on the board of Children of Bellevue, a non-profit organization focused on advocating and developing pediatric programs at Bellevue Hospital Center.

Meckler holds a B.S.

in Industrial Management and M.S.

in Industrial Administration from Carnegie Mellon University.

In addition, Mr.

Meckler received a J.D.

from Fordham University School of Law.

Orwin has served as a director of the Company since March 2017.

From April 2018 to June 2024, Mr.

Orwin served as the President and Chief Executive Officer of Atreca, Inc., a biopharmaceutical company.

From June 2013 through June 2017 he served as Chief Executive Officer of Relypsa, Inc., and from June 2013 through March 2017 also served as its President and on its board of directors from June 2013 until Relypsa’s acquisition by the Galenica Group in September 2016.

Prior to Relypsa, Mr.

Orwin served as President and Chief Operating Officer of Affymax, Inc., a biotechnology company, from April 2010 to January 2011, and as Affymax’s Chief Executive Officer and a member of the board of directors from February 2011 to May 2013.

Earlier in his career he served as Vice President and then Senior Vice President of the BioOncology Business Unit at Genentech, Inc.

(now a member of the Roche Group), and served in various executive-level positions at Johnson & Johnson.

Prior to such roles, Mr.

Orwin held senior marketing and sales positions at various life sciences and pharmaceutical companies, including Alza Corporation (acquired by Johnson & Johnson), SangStat Medical Corporation (acquired by Genzyme), Rhone-Poulenc Rorer Pharmaceuticals, Inc.

(merged with Sanofi-Aventis) and Schering-Plough Corporation (merged with Merck).

Orwin currently serves as the Chair of the Board of Directors of CARGO Therapeutics, Inc., a biotechnology company, and as the Chair of the Board of Directors for AnaptysBio, Inc., a clinical-stage biotechnology company.

Additionally, Mr.

Orwin currently serves as the Chair of the Board of Directors of the privately held company Nested Therapeutics, on the Board of Directors of the privately held company Ambrosia Biosciences, Inc., and as the Executive Chair of the Board of Directors of the privately held company Agni Bio, Inc., and is a Venture Partner in Samsara BioCapital.

Previously, Mr.

Orwin served as a member of the Board of Directors of Seagen Inc.

from January 2014 until its acquisition by Pfizer in December of 2023, the board of directors of NeurogesX, Inc., and on the board of directors of Array BioPharma Inc.

from November 2012 until its acquisition by Pfizer in July of 2019.

Orwin received a B.A.

in Economics from Rutgers University and an M.B.A.

from New York University.

Sandra Poole has served as a director of the Company since May 2019.

Since July 2020, Ms.

Poole has served as the Chief Operating Officer of Mythic Therapeutics, a clinical stage biotechnology company advancing antibody-drug conjugates (ADCs) for cancer therapy.

Poole has deep expertise in product development, technical operations, company building, operations and strategy from a greater than 25-year career in the biopharmaceutical industry.

She is the former Chief Operating Officer at Candel Therapeutics, a biotechnology company focused on developing viral immunotherapies, where she served from January 2020 to March 2020.

Prior to Candel Therapeutics she served as Chief Operating Officer at LogicBio Therapeutics Inc.

(acquired by Alexion), a company focused on developing genetic medicines for rare diseases.

Prior to LogicBio, Ms.

Poole served in executive leadership roles of increasing responsibility at ImmunoGen, Inc.

(acquired by AbbVie Inc.), a company focused on developing ADC therapies, where she most recently served as executive Vice President of Technical Operations and Commercial Development.

Earlier in her career, Ms.

Poole spent more than 15 years in CMC product development and manufacturing leadership positions at Genzyme (now Sanofi), most recently serving as SVP of Biologics Manufacturing, managing global biomanufacturing of six commercial therapies for rare disease across five manufacturing sites in the US and EU including Cerezyme®, Fabrazyme®, and Myozyme®/Lumizyme®.

Previously, Ms.

Poole served on the Supervisory Board for Valneva, SE a France based biotechnology company developing vaccines for infectious diseases, and on the Board of Directors of ViaCyte, a privately held biotechnology company developing novel stem cell-derived cell replacement therapies until its acquisition by Vertex Pharmaceuticals Incorporated in July of 2022.

Poole holds an M.A.Sc.

and a B.A.Sc.

in chemical engineering from the University of Waterloo (Ontario, Canada).

Ron Squarer has served as a director of the Company since April 2017.

Since March 2020, Mr.

Squarer has served as Chair of the Board of Directors of ADC Therapeutics SA, a commercial-stage biopharmaceutical company.

Previously, from June 2023 to June 2024, Mr.

Squarer served as Chair of the Board of Directors of Deciphera Pharmaceuticals, Inc., a commercial-stage biopharmaceutical company, where he had also served as a Director since December 2019, through its acquisition by Ono Pharmaceuticals Co., Ltd.

for approximately $2.5 billion.

Squarer has extensive commercial, development and executive leadership expertise from a greater than 25-year career in the pharmaceutical industry.

Previously, Mr.

Squarer served as the Chief Executive Officer and a member of the Board of Directors of Array BioPharma, Inc., an oncology focused biopharmaceutical company from April 2012 to July 2019, when Array BioPharma, Inc.

was acquired by Pfizer, Inc.

at an enterprise value of approximately $11.4 billion.

Prior to this, Mr.

Squarer held positions of increasing responsibility with Hospira Inc., a global pharmaceutical and medical device company, including serving as Senior Vice President, Chief Commercial Officer, where he was responsible for delivering $4 billion in annual revenue and leading more than 2,000 employees worldwide.

Squarer joined Hospira from Mayne Pharma, an oncology-focused, global pharmaceutical company, where he served as Senior Vice President, Global Corporate and Business Development when Mayne was sold to Hospira for $2 billion in 2007.

Prior to Mayne Pharma, Mr.

Squarer held senior management roles at both Pfizer, Inc., focused on global oncology commercial development, and at SmithKline Beecham Pharmaceuticals (now GlaxoSmithKline) in the U.S.

Squarer holds an MBA from the Kellogg School of Management, Northwestern University and a bachelor’s degree in biochemistry from the University of California, Berkeley.

Ruth Williams-Brinkley has served as a director of the Company since September 2021.

In January 2024, Ms.

Williams-Brinkley retired as President of the Kaiser Foundation Health Plan of the Mid-Atlantic States, where she led all of Kaiser Permanente’s care delivery and health plan operations in Washington, D.C., suburban Maryland, Baltimore, and Northern Virginia since June 2020.

She joined Kaiser Permanente in 2017 as President of Kaiser Foundation Health Plan and Hospitals of the Northwest, in Portland, Oregon.

Prior to joining Kaiser, Ms.

Williams-Brinkley served as CEO of KentuckyOne Health, an affiliate of CommonSpirit Health, from 2011 to 2017, as President and CEO of Carondelet Health Network in Tucson, Arizona, an affiliate of Ascension Health, from 2008 to 2011, and as President and CEO of Memorial Health Care System of Chattanooga, Tennessee, an affiliate of CommonSpirit Health, from 2002 to 2008.

Currently Ms.

Williams-Brinkley serves on the Board of Directors of Natera, Inc., on the Board of Trustees of the University of Phoenix, and on the Board of Directors of the privately held companies OOTify, Inc.

and Swan AI Studios.

Additionally, Ms.

Williams-Brinkley currently serves on the not for profit Boards of DePaul University in Chicago, Illinois, Allina Health and The Leverage Network.

Previously, she served as a member of the Board of Directors of Results Physiotherapy, a private care delivery company until it was acquired by Upstream Rehabilitation in 2021, and Chattem, Inc.

until it was acquired by Sanofi in 2009.

Earlier in her career, Ms.

Williams-Brinkley held various nursing staff and management roles of increasing responsibility.

Williams-Brinkley received her B.S.

and Master of Science in Nursing from DePaul University and is a Life Fellow of the American College of Healthcare Executives.

In addition to Dr.

Dube, our executive officers are as follows:

Christopher Cline has served as the Chief Financial Officer of the Company since August 2022.

Cline brings more than 15 years of industry experience in investor relations, corporate communications, and financial strategy, planning and analysis to the chief financial officer position.

Previously, Mr.

Cline served as senior vice president, investor relations and corporate communications at the Company.

Since joining the Company in 2014, Mr.

Cline has been responsible for leading engagement with the investment community, as well as building a developed corporate communications infrastructure and strategy.

Prior to the Company, Mr.

Cline was a member of the global investor relations group at Elan Corporation, plc, and the financial planning and analysis group at Phase Forward.

Cline is a CFA charter holder and holds a degree in finance from the Williams College of Business at Xavier University.

Peter Heerma has served as Chief Commercial Officer of the Company since October 2019.

Previously, Mr.

Heerma served as Global Product General Manager for oncology and cardiovascular products at Amgen Inc., a biotechnology company, from December 2015 to September 2019.

From December 2003 until November 2015, Mr.

Heerma held roles of increasing responsibility at Abbott Laboratories (“Abbott”), and following Abbott’s spin-off of AbbVie, Inc., a biopharmaceutical company, at AbbVie.

These roles included Senior Director of Portfolio Strategy for hepatology and nephrology, Senior Director and Asset Team Lead for HCV, diabetic nephropathy, and neuroscience development projects (all AbbVie), Director of Commercial Strategy Renal Care, International Marketing Director, Business Unit Manager of hospital products, and Product Manager for obesity and cardiovascular products (all Abbott).

Heerma holds a Master of Science in European business administration and business law from the Lund University in Sweden and a Bachelor of Science in retail management and marketing from Stenden University in the Netherlands.

Jula Inrig has served as Chief Medical Officer of the Company since January 2022.

Previously, Dr.

Inrig served as Global Head of the Renal Center of Excellence at IQVIA, a global provider of analytics, technology solutions, and clinical research services to the life sciences industry, from September 2017 to December 2021, where she helped develop the design, execution and strategy of clinical trials leading to FDA and European Commission approvals in autosomal dominant polycystic kidney disease (ADPKD), and diabetic kidney disease.

From August 2012 to March 2015 Dr.

Inrig served as Medical Director, and then as Senior Medical Director from April 2015 to December 2021 and was responsible for the execution of numerous global clinical trials, including pivotal phase 3 trials in FSGS, IgAN and lupus nephritis.

From March 2013 to January 2018 Dr.

Inrig served on the board of directors for the Kidney Health Initiative, a public-private partnership with the FDA, working to improve the development of therapies for patients with kidney disease.

Inrig has authored or co-authored over 50 peer-reviewed publications and editorials and is currently a member of several professional medical societies.

Inrig is board certified in nephrology and internal medicine and has served on the faculty at the University of California, Irvine, and as an adjunct in the Department of Medicine at the Duke University School of Medicine.

Inrig holds a B.A.

from California State University, Sacramento, and received her M.D.

from Loma Linda University and completed her internal medicine residency, her nephrology fellowship and Masters of Health Science at Duke University.

Reed has served as Senior Vice President, General Counsel and Corporate Secretary of the Company since January 2017.

Previously, Ms.

Reed served as Vice President, General Counsel and Secretary of Celladon Corporation, a publicly traded biotechnology company, from June 2014 to March 2016 and served as a legal consultant for companies in the life sciences industry from 2013 to June 2014 and again during 2016.

From 2001 to 2012, Ms.

Reed led the legal function at Anadys Pharmaceuticals, Inc., a publicly traded biopharmaceutical company, including serving as Senior Vice President, Legal Affairs, General Counsel and Corporate Secretary until Anadys’ acquisition by Roche.

Prior to Anadys, Ms.

Reed was an attorney with the law firms Cooley LLP and Brobeck, Phleger & Harrison LLP.

Reed is a member of the State Bar of California and received her B.S.

in Business Administration from the Haas School of Business at the University of California, Berkeley and holds a J.D., cum laude, from Harvard Law School.

Rote has served as Senior Vice President of Research & Development of the Company since February 2017.

Previously, Dr.

Rote led clinical development at Ardea Biosciences, a wholly owned subsidiary of AstraZeneca, serving as Vice President, Clinical Development from September 2014 to July 2016.

From 2003 to 2014, Dr.

Rote held numerous positions of increasing responsibility at Amylin Pharmaceuticals, Inc., a biopharmaceutical company, including Vice President, Site Head for Research & Development from September 2012 to July 2014, Vice President, Research & Product Development from January 2010 to September 2012, and Vice President, Corporate Development, New Ventures, from 2007 to 2010, among others.

Prior to Amylin, Dr.

Rote served as Executive Director, Development of Corvas International, a biopharmaceutical company.

He earned both his Ph.D.

in Pharmacology and B.S.

in Pre-Medicine from Pennsylvania State University and received postdoctoral training from the University of Michigan.

We have adopted a Code of Business Conduct that applies to our directors and employees (including our principal executive officer, principal financial officer, principal accounting officer and controller), and have posted the text of the policy on our website (https://ir.travere.com/governance-documents).

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EXECUTIVE COMPENSATION

Information required by this item will be contained under the captions “Compensation Discussion and Analysis,” “Executive Compensation,” “Director Compensation Summary” and “Compensation Committee Interlocks and Insider Participation” in the Proxy Statement.

Such information is incorporated herein by reference.

Information required by this item will be contained under the captions “Compensation Discussion and Analysis,” “Executive Compensation,” “Director Compensation Summary”, “Compensation Committee Interlocks and Insider Participation,” and "Compensation Committee Report" in the Proxy Statement.

Such information is incorporated herein by reference, provided that the information required by Item 402(x) of Regulation S-K shall be set forth in under the heading “Policies and Practices Related to the Grant of Certain Equity Awards Close in Time to the Release of Material Nonpublic Information” in the Proxy Statement and is incorporated herein by reference.

SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

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The exhibits to this report are listed in the exhibit index below.

2.1* Asset Purchase Agreement, dated January 10, 2015, by and between the Company and Asklepion Pharmaceuticals, LLC (incorporated by reference to Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q, filed with the SEC on August 3, 2023).

Stock Purchase Agreement, dated October 21, 2020, by and among the Company, Orphan Technologies Limited and Citco Trustees (Cayman) Limited acting solely in its capacity as the sole trustee of The Fuhrer Family Trust (incorporated by reference to Exhibit 2.1 to the Company’s Current Report on Form 8-K, filed with the SEC on November 18, 2020).

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Bank National Association, as Trustee (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K, filed with the SEC on September 10, 2018).

4.4 First Supplemental Indenture, dated September 10, 2018, between the Company and U.S.

Bank National Association, as Trustee (including the form of 2.50% Convertible Senior Note due 2025) (incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K, filed with the SEC on September 10, 2018).

4.4 Second Supplemental Indenture, dated March 11, 2022, between the Company and U.S.

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(incorporated by reference to Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q, filed with the SEC on May 4, 2023).

10.8† Non-Employee Director Compensation Program, as amended (incorporated by reference to Exhibit 10.1 to the Company's Quarterly Report on Form 10-Q, filed with the SEC on May 6, 2024).

10.8† Non-Employee Director Compensation Program, as amended (incorporated by reference to Exhibit 10.

2 to the Company's Quarterly Report on Form 10-Q, filed with the SEC on May 1 , 202 5 ).

10.9† The Company's 202 6 Executive Officer Annual Bonus Plan .

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10.30 Fourth Amendment to Trademark License and Supply Agreement dated as of November 28, 2018, between the Company and Mission Pharmacal (incorporated by reference to Exhibit 10.19 to the Company’s Annual Report on Form 10-K, filed with the SEC on February 26, 2019).

10.31* Fifth Amendment to Trademark License and Supply Agreement dated as of September 30, 2020, between the Company and Mission Pharmacal Company (incorporated by reference to Exhibit 10.

32 to the Company's Annual Report on Form 10-K, filed with the SEC on February 20, 2024).

10.31* Fifth Amendment to Trademark License and Supply Agreement dated as of September 30, 2020, between the Company and Mission Pharmacal Company (incorporated by reference to Exhibit 10.32 to the Company's Annual Report on Form 10-K, filed with the SEC on February 20, 2024).

10.32↡* Master Manufacturing Supply Agreement, dated September 30, 2020, between the Company and STA Pharmaceutical Hong Kong Limited, a subsidiary of WuXi AppTec (incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q, filed with the SEC on November 5, 2020).

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(incorporated by reference to Exhibit 10.39 to the Company's Annual Report on Form 10-K, filed with the SEC on February 23, 2023).

Amendment No.

2 to the License and Collaboration Agreement, effective as of June 24, 2025, by and between Travere Therapeutics Switzerland GmbH (formerly known as Orphan Technologies Limited) and Vifor (International) Ltd (incorporated by reference to Exhibit 10.2 to the Company's Quarterly Report on Form 10-Q, filed with the SEC on August 6, 2025).

Commercial Supply Agreement, dated December 21, 2021, between the Company and Catalent Pharma Solutions, LLC (incorporated by reference to Exhibit 10.40 to the Company's Annual Report on Form 10-K for the year ended December 31, 2021, filed with the SEC on February 24, 2022).

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(incorporated by reference to Exhibit 99.2 to the Company’s Current Report on Form 8-K, filed with the SEC on June 8, 2020).

19.1 Insider Trading Policy.

19.1 Insider Trading Policy (incorporated by reference to Exhibit 19.1 to the Company’s Annual Report on Form 10-K, filed with the SEC on February 21, 2025).

21.1 List of subsidiaries of the Company.

23.1 Consent of Ernst & Young.

23.2 Consent of BDO USA, P.C.

24.1 Power of Attorney (see signature page hereto).

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Report of Independent Registered Public Accounting Firm (Ernst & Young LLP, San Diego, California, PCAOB ID:

Report of Independent Registered Public Accounting Firm (BDO USA, P.C., San Diego, California, PCAOB ID:

Financial Statements

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We have audited the accompanying consolidated balance sheets of Travere Therapeutics, Inc.

and subsidiaries (the Company) as of December 31, 2024 and 2023, the related consolidated statements of operations and comprehensive loss, stockholders’ equity and cash flows for each of the two years in the period ended December 31, 2024 and the related notes (collectively referred to as the “consolidated financial statements”).

In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2024 and 2023, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2024, in conformity with U.S.

and subsidiaries (the Company) as of December 31, 2025 and 2024, the related consolidated statements of operations and comprehensive loss, stockholders’ equity and cash flows for each of the three years in the period ended December 31, 2025, and the related notes (collectively referred to as the “consolidated financial statements”).

In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at 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 U.S.

generally accepted accounting principles.

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February 19, 2026

Report of Independent Registered Public Accounting Firm

Shareholders and Board of Directors

TRAVERE THERAPEUTICS, INC.

San Diego, California

Opinion on the Consolidated Financial Statements

We have audited the accompanying consolidated statements of operations and comprehensive loss, stockholders’ equity, and cash flows of Travere Therapeutics, Inc.

and subsidiaries (the “Company”) for the year ended December 31, 2022, and the related notes (collectively referred to as the “consolidated financial statements”).

In our opinion, the consolidated financial statements present fairly, in all material respects, the results of its operations and its cash flows for the year ended December 31, 2022, in conformity with accounting principles generally accepted in the United States of America.

Change in Accounting Principle

As discussed in Note 2 to the consolidated financial statements, effective January 1, 2022, the Company adopted Accounting Standards Update (“ASU”) No.

2020-06, Debt — Debt with Conversion and Other Options (“Subtopic 470-20”) and Derivatives and Hedging — Contracts in Entity’s Own Equity (“Subtopic 815-40”):

Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (“ASU 2020-06”).

Basis for Opinion

These consolidated financial statements are the responsibility of the Company’s management.

Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audit.

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 audit in accordance with the standards of the PCAOB.

Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud.

Our audit 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 audit 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.

We believe that our audit provides a reasonable basis for our opinion.

/s/ BDO USA, P.C.

We served as the Company’s auditor from 2014 to 2023.

San Diego, California

February 23, 2023, except for the effects of discontinued operations discussed in Notes 1 and 19, as to which the date is February 20, 2024 and Note 20, as to which the date is February 20, 2025.

TRAVERE THERAPEUTICS, INC.

AND SUBSIDIARIES

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Convertible debt, current portion — 68,678

Deferred revenue, current portion 2,815 7,096

Operating lease liabilities, current portion 5,875 5,405

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Operating loss ( 62,824 ) ( 323,827 ) ( 388,138 )

Other income (expense), net:

Other income, net:

Interest income 12,721 17,817 21,768

Interest expense ( 10,748 ) ( 11,182 ) ( 11,334 )

Other (expense) income, net ( 3,318 ) 1,594 974

Loss on extinguishment of debt — — ( 7,578 )

Total other income (expense), net 3,317 12,028 ( 11,342 )

Other income (expense), net 11,578 ( 3,318 ) 1,594

Total other income, net 13,551 3,317 12,028

Loss from continuing operations before income tax provision ( 49,273 ) ( 320,510 ) ( 376,110 )

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Loss from continuing operations, net of tax ( 50,261 ) ( 320,630 ) ( 376,333 )

(Loss) income from discontinued operations, net of tax ( 915 ) 264,934 52,986

Income (loss) from discontinued operations, net of tax 24,715 ( 915 ) 264,934

Net loss $ ( 25,546 ) $ ( 321,545 ) $ ( 111,399 )

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Net loss from continuing operations $ ( 0.57 ) $ ( 4.07 ) $ ( 5.07 )

Net (loss) income from discontinued operations ( 0.01 ) 3.57 0.83

Net income (loss) from discontinued operations 0.28 ( 0.01 ) 3.57

Net loss per common share $ ( 0.29 ) $ ( 4.08 ) $ ( 1.50 )

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Unrealized gain (loss) on defined benefit pension plan 219 328 ( 374 )

Foreign currency translation gain (loss) 1,422 ( 1,871 ) 507

Foreign currency translation (loss) gain ( 945 ) 1,422 ( 1,871 )

Unrealized (loss) gain on marketable debt securities ( 383 ) ( 374 ) 3,696

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BALANCE - DECEMBER 31, 2022 64,290,570 $ 6 $ 1,059,975 $ ( 2,907 ) $ ( 1,014,223 ) $ 42,851

Cumulative-effect adjustment from adoption of ASU 2020-06 — — ( 74,945 ) — 30,225 ( 44,720 )

Share based compensation — — 43,985 — — 43,985

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Employee stock purchase program purchase and expense 326,521 — 4,853 — — 4,853

Issuance of common stock under At-The-Market offering, net of issuance costs of $ 0.6 million.

Equity offering, net of issuance costs of $ 12.6 million

9,703,750 1 191,198 — — 191,199

Issuance of pre-funded common stock warrants, net of issuance costs of $ 1.6 million

— — 24,630 — — 24,630

Unrealized loss on defined benefit pension plan — — — ( 374 ) — ( 374 )

Foreign currency translation adjustments — — — ( 1,871 ) — ( 1,871 )

Unrealized loss on marketable debt securities — — — ( 2,484 ) — ( 2,484 )

Unrealized gain on marketable debt securities — — — 3,696 — 3,696

Net loss — — — — ( 111,399 ) ( 111,399 )

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8,984,375 1 134,737 — — 134,738

Issuance of pre-funded common stock warrants, net of issuance costs of $ 1.6 million

— — 24,630 — — 24,630

Unrealized loss on defined benefit pension plan — — — ( 374 ) — ( 374 )

Exercise of pre-funded common stock warrants 1,250,000 — — — — —

Unrealized gain on defined benefit pension plan — — — 328 — 328

Foreign currency translation adjustments — — — 1,422 — 1,422

Unrealized gain on marketable debt securities — — — 3,696 — 3,696

Unrealized loss on marketable debt securities — — — ( 374 ) — ( 374 )

Net loss — — — — ( 321,545 ) ( 321,545 )

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Employee stock purchase program purchase and expense 215,516 — 4,181 — — 4,181

Equity offering, net of issuance costs of $ 9.0 million

8,984,375 1 134,737 — — 134,738

Exercise of pre-funded common stock warrants 1,250,000 — — — — —

Unrealized gain on defined benefit pension plan — — — 219 — 219

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Net loss $ ( 25,546 ) $ ( 321,545 ) $ ( 111,399 )

Net (loss) income from discontinued operations ( 915 ) 264,934 52,986

Net income (loss) from discontinued operations 24,715 ( 915 ) 264,934

Net loss from continuing operations ( 50,261 ) ( 320,630 ) ( 376,333 )

Adjustments to reconcile net loss to net cash used in operating activities:

Adjustments to reconcile net loss to net cash provided by (used in) operating activities:

Depreciation and amortization 60,743 43,555 38,530

1 unchanged sentence

In-process research and development — 65,205 —

Loss on extinguishment of debt — — 7,578

Loss on allowance for inventory 684 2,819 3,039

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Inventory 5,016 ( 3,771 ) ( 39,420 )

Tax receivable ( 41 ) ( 35 ) ( 374 )

Income taxes 849 ( 41 ) ( 35 )

Prepaid expenses and other current and non-current assets ( 7,658 ) ( 3,164 ) ( 4,657 )

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Other current and non-current liabilities ( 9,700 ) 5,646 ( 418 )

Net cash used in operating activities - continuing operations ( 230,024 ) ( 325,357 ) ( 260,846 )

Net cash provided by (used in) operating activities - continuing operations 37,784 ( 230,024 ) ( 325,357 )

Net cash (used in) provided by operating activities - discontinued operations — ( 7,451 ) 45,336

Net cash used in operating activities ( 237,475 ) ( 280,021 ) ( 186,291 )

Net cash provided by (used) in operating activities 37,784 ( 237,475 ) ( 280,021 )

Cash Flows From Investing Activities:

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Net cash provided by investing activities - discontinued operations — — 207,402

Net cash provided by (used in) investing activities 99,325 55,776 ( 32,553 )

Net cash provided by investing activities 27,892 99,325 55,776

For the year ended December 31,

2025 2024 2023

Cash Flows From Financing Activities:

Payment of guaranteed minimum royalty ( 2,100 ) ( 2,100 ) ( 2,100 )

Proceeds from issuance of 2029 convertible senior notes — — 316,250

Payment of debt issuance costs — — ( 9,882 )

Repurchase of 2025 convertible senior notes including premium — — ( 211,324 )

Repayment of 2025 convertible senior notes ( 68,904 ) — —

Proceeds from the issuance of common stock, net of issuance costs — 134,738 191,198

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Proceeds from the issuances under the employee stock purchase plan 2,792 2,332 3,166

Proceeds from the issuance of common stock in At-the-Market equity offering — — 19,545

Net cash provided by financing activities - continuing operations 139,422 220,134 120,052

Net cash (used in) provided by financing activities - continuing operations ( 33,467 ) 139,422 220,134

Net cash used in financing activities - discontinued operations — — ( 1,382 )

Net cash provided by financing activities 139,422 218,752 117,573

Net cash (used in) provided by financing activities ( 33,467 ) 139,422 218,752

Effect of exchange rate changes on cash 2,291 ( 913 ) 1,981

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Cash paid for interest $ 8,838 $ 8,838 $ 8,838

Cash paid for income taxes $ ( 453 ) $ ( 578 ) $ ( 996 )

Non-cash investing and financing activities:

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("Mirum Pharmaceuticals" or “Mirum”), pursuant to which Mirum agreed to purchase from Travere substantially all of the assets primarily related to Travere’s business of development, manufacture (including synthesis, formulation, finishing or packaging) and commercialization of Chenodal and Cholbam (also known as Kolbam, and together with Chenodal, the “Products”) (collectively, the "bile acid business").

On August 31, 2023, the Company and Mirum consummated the transactions contemplated by the Purchase Agreement (the “Closing”).

In August 2023, the Company and Mirum consummated the transactions contemplated by the Purchase Agreement (the “Closing”).

In connection with the Closing, Mirum paid Travere an upfront cash payment of $ 210.0 million.

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The Company has reflected the bile acid business as a discontinued operation in the consolidated financial statements for all periods presented.

Mirum achieved the first such milestone based on its annual net sales in 2025, and Travere recognized a milestone payment of $ 25.0 million for the year ended December 31, 2025 in discontinued operations, as a result of such achievement.

See Note 19 for further discussion.

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FILSPARI® (sparsentan)

On September 5, 2024, the FDA granted full approval of FILSPARI® (sparsentan) to slow kidney function decline in adults with primary Immunoglobulin A nephropathy (IgAN) who are at risk of disease progression.

FILSPARI is the only oral, once-daily, non-immunosuppressive medication that directly targets glomerular injury in the kidney by blocking two critical pathways of IgAN disease progression (endothelin-1 and angiotensin II).

In September 2024, the FDA granted full approval of FILSPARI® (sparsentan) to slow kidney function decline in adults with primary Immunoglobulin A nephropathy (IgAN) who are at risk of disease progression.

FILSPARI had previously been granted accelerated approval in February 2023 based on the surrogate marker of proteinuria.

Full approval is based on positive long-term confirmatory results from the PROTECT Study demonstrating that FILSPARI significantly slowed kidney function decline over two years compared to irbesartan.

In September 2021, the Company entered into a license and collaboration agreement with Vifor (International) Ltd.

Full approval was based on positive long-term confirmatory results from the PROTECT Study demonstrating that FILSPARI significantly slowed kidney function decline over two years compared to irbesartan.

In September 2021, the Company entered into a license and collaboration agreement (the "CSL Vifor License Agreement") with Vifor (International) Ltd.

("CSL Vifor").

In April 2024, the Company and CSL Vifor announced that the European Commission has granted conditional marketing authorization (“CMA”) for FILSPARI (sparsentan) for the treatment of adults with primary IgAN with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.75 g/g).

The CMA is granted for all member states of the European Union, as well as in Iceland, Liechtenstein and Norway.

The European Commission's decision follows the positive opinion from the Committee for Medicinal Products for Human Use (“CHMP”) in February 2024, based on results from the pivotal Phase 3 PROTECT Study of FILSPARI in IgAN.

Under the terms of the License Agreement, the Company will be entitled to receive a regulatory milestone payment of $ 17.5 million upon receipt of full regulatory approval by the European Commission for IgAN, and an additional milestone payment upon achievement of market access initiatives in certain countries.

In April 2024, the Company and CSL Vifor announced that the European Commission had granted conditional marketing authorization (“CMA”) for FILSPARI (sparsentan) for the treatment of adults with primary IgAN with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ("UPCR") ≥0.75 g/g), and in April 2025, the Company and CSL Vifor announced that the European Commission had converted the CMA into a standard marketing authorization (“MA”) for FILSPARI for the treatment of adults with primary IgAN with a urine protein excretion ≥1.0 g/day (or UPCR ≥0.75 g/g).

The MA was granted for all member states of the European Union, as well as in Iceland, Liechtenstein and Norway.

As a result of the standard MA approval, the Company received a regulatory milestone payment of $ 17.5 million in May 2025 under the terms of the CSL Vifor License Agreement.

FILSPARI became commercially available in Europe under the CMA in August 2024, with an initial launch in Germany and Austria.

In October 2024, the Company and CSL Vifor announced that Swissmedic has granted temporary marketing authorization for FILSPARI for the treatment of adults with primary IgAN with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.75 g/g).

In November 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) approved FILSPARI in the United Kingdom.

In January 2024, the Company entered into an exclusive licensing agreement with Renalys Pharma, Inc.

("Renalys"), to bring sparsentan for the treatment of IgAN to patients in Japan and other countries in Asia, for the treatment of IgAN.

Renalys will hold regional rights to sparsentan for Japan, South Korea, Taiwan, Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand, and Vietnam.

Following successful meetings with the Pharmaceuticals and Medical Devices Agency (PMDA) in 2023, in the second quarter of 2024 Renalys initiated an

open label registration study of sparsentan in Japan to support potential approval of sparsentan in Japan.

In July 2024, Renalys announced that the first patient was dosed in the study, and in January 2025, Renalys announced achievement of full enrollment in the study.

In December 2024, Renalys announced that sparsentan received Orphan Drug Designation from the Japanese Ministry of Health, Labour and Welfare for the indication of primary IgA nephropathy as of November 27, 2024.

Under the terms of the licensing agreement, Renalys will be responsible for development, regulatory matters, and commercialization in the licensed territories.

In October 2024, the Company and CSL Vifor announced that Swissmedic had granted temporary marketing authorization for FILSPARI for the treatment of adults with primary IgAN with a urine protein excretion ≥1.0 g/day (or UPCR ≥0.75 g/g).

In April 2025, the Medicines and Healthcare products Regulatory Agency ("MHRA") in the UK converted its conditional approval of FILSPARI in IgAN to standard approval.

During the third quarter of 2025, the Company recognized a $ 40.0 million market access milestone from CSL Vifor;

payment was received in the fourth quarter of 2025.

In January 2024, the Company entered into an exclusive licensing agreement (the "Chugai License Agreement") with Renalys Pharma, Inc.

("Renalys"), to bring sparsentan for the treatment of IgAN to patients in Japan and other countries in Asia.

In December 2024, Renalys announced that sparsentan received Orphan Drug Designation from the Japanese Ministry of Health, Labour and Welfare for the indication of primary IgA

nephropathy in November 2024.

In the fourth quarter of 2025, Renalys announced positive topline results from its Phase 3 study of sparsentan in Japanese patients with IgAN.

Renalys has also announced that it has reached an agreement with the PMDA regarding development plans for two other Phase 3 clinical trials of sparsentan, one investigating the use of sparsentan in focal segmental glomerulosclerosis (FSGS) and the other in Alport syndrome, in Japan.

In the fourth quarter of 2025, Renalys was acquired by and merged into Chugai Pharmaceutical Co., Ltd.

Through the acquisition, Chugai gained exclusive rights to develop and commercialize sparsentan in Japan, South Korea, and Taiwan.

As a minority shareholder in Renalys, Travere received $ 10.2 million at the closing of the transaction and Travere is also eligible to receive multiple milestones according to the progress of sparsentan regulatory approval, and consideration linked to sparsentan's net sales in the applicable territory.

Under the terms of the licensing agreement, Chugai is responsible for development, regulatory matters, and commercialization in the licensed territories.

Chugai plans to file for the regulatory approval for sparsentan in Japan in 2026.

Thiola® and Thiola EC® (tiopronin tablets)

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Sparsentan for the treatment of FSGS

Sparsentan remains a novel investigational product candidate which has been granted Orphan Drug Designation for the treatment of focal segmental glomerulosclerosis (FSGS) in the U.S.

Sparsentan remains a novel investigational product candidate which has been granted Orphan Drug Designation for the treatment of FSGS in the U.S.

and the European Economic Area countries (the “EEA”).

In December 2023, the Company announced that it had completed a planned Type C meeting with the FDA to discuss previously reported results from the Phase 3 DUPLEX Study of sparsentan in FSGS.

In December 2023, the Company announced that it had completed a planned Type C meeting with the FDA to discuss results from the Phase 3 DUPLEX Study of sparsentan in FSGS.

The FDA acknowledged the high unmet need for approved therapies as well as the challenges in studying FSGS but indicated that the two-year results from the Phase 3 DUPLEX Study alone were not sufficient to support an sNDA submission.

In February 2025, the Company announced that it had completed a Type C meeting with the FDA and that the Company plans to submit an sNDA around the end of the first quarter of 2025.

The sNDA will be based on existing data from the Phase 3 DUPLEX and Phase 2 DUET studies of FILSPARI.

In February 2025, the Company announced that it had completed a Type C meeting with the FDA and in March 2025, the Company announced that it had submitted an sNDA to the FDA seeking traditional approval of FILSPARI for the treatment of FSGS.

In May 2025, the Company announced that the FDA accepted the sNDA, assigned a Prescription Drug User Fee Act ("PDUFA") target action date of January 13, 2026, and initially indicated that it planned to hold an advisory committee meeting to discuss the application.

In September 2025, following further review of the sNDA, the FDA informed the Company that an advisory committee meeting was no longer needed.

In January 2026, the FDA extended the review timeline of the sNDA, and that the new PDUFA target action date is April 13, 2026.

The extension followed the recent submission of responses requested by the FDA to further characterize the clinical benefit of FILSPARI.

The FDA determined that the additional responses constituted a Major Amendment to the sNDA and extended the action date accordingly.

The sNDA remains under review by the FDA with a PDUFA target action date of April 13, 2026.

Pegtibatinase

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In September 2024, the Company announced a voluntary pause of enrollment in the Phase 3 HARMONY Study.

The voluntary enrollment pause enables the Company to work to address necessary process improvements in manufacturing scale-up to support commercial scale manufacturing as well as full enrollment in the HARMONY Study.

Patients currently enrolled in pegtibatinase studies continue to receive study medication from small scale batches which are unaffected by the scale-up process.

Currently enrolled patients will be able to continue on study medication as scheduled for the duration of the trials they are participating in.

The voluntary enrollment pause was enacted following our determination that the desired drug substance profile was not achieved in the recent scale-up process.

The Company expects to further evaluate the necessary commercial process improvements to enable the continuation of the Phase 3 program.

The voluntary enrollment pause was enacted following the Company's determination that the desired drug substance profile was not achieved in the initial scale-up process, and it enabled the Company to address necessary process improvements in manufacturing scale-up to support initial commercial scale manufacturing as well as full enrollment in the HARMONY Study.

Currently enrolled patients will be able to continue on study medication as scheduled for the duration of the trials in which they are participating.

Following further optimization of the manufacturing process in 2025, the Company restarted enrollment activities for the pivotal Phase 3 HARMONY Study in the first quarter of 2026.

The Company acquired pegtibatinase as part of the November 2020 acquisition of Orphan Technologies Limited.

Preclinical Programs:

The Company is party to a collaboration agreement with PharmaKrysto Limited and their early-stage cystinuria discovery program, whereby the Company is responsible for funding all research and development expenses for the pre-clinical activities associated with the cystinuria program.

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

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The Company periodically analyzes its inventory levels to identify inventory that may expire prior to expected sale or has a cost basis in excess of its estimated realizable value, and writes down such inventory as appropriate.

In addition, the Company's products are

subject to strict quality control and monitoring which the Company’s manufacturers perform throughout their manufacturing process.

In addition, the Company's products are subject to strict quality control and monitoring which the Company’s manufacturers perform throughout their manufacturing process.

The Company does not directly manufacture any product.

The Company has a single supplier for its product Thiola, and utilizes contract service providers for the manufacture of the active pharmaceutical ingredient for FILSPARI and the manufacture of primary packaging, secondary packaging and serialization for its product FILSPARI.

The inventory reserve was $ 3.7 million and $ 2.4 million at December 31, 2024 and 2023, respectively.

Inventory, net of reserves, consisted of the following at December 31, 2025 and 2024 ( in thousands ):

10 unchanged sentences

The Company maintains levels of these inventories beyond a one-year production plan to limit exposure to potential supply disruption.

Such inventories are classified as long-term.

Cost of goods sold includes the cost of inventory sold, third party manufacturing and supply chain costs, product shipping, tracking and handling costs, and provisions for excess and obsolete inventory.

Cost of goods sold also includes the cost of goods sold under the Company's license and collaboration agreements, which generally consists of the sale of active pharmaceutical ingredients to the Company's collaboration partners, generally at cost plus a margin.

Cost of goods sold includes the cost of inventory sold, third party manufacturing and supply chain costs, product shipping and handling costs, and provisions for excess and obsolete inventory.

Cost of goods sold also includes the cost of goods sold under the Company's license and collaboration agreements, which currently consists of the sale of active pharmaceutical ingredients to the Company's collaboration partners, at cost or at cost plus a margin.

The following table summarizes cost of goods sold for the years ended December 31, 2025, 2024 and 2023 ( in thousands ):

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For the year ended December 31, 2025, sales of FILSPARI primarily consisted of zero-cost inventories.

As of December 31, 2024, the Company had approximately $ 2.3 million of zero-cost inventory remaining, the majority of which the Company expects will be consumed in 2025.

As of December 31, 2025 the zero-cost inventory remaining was immaterial.

The Company began capitalizing inventory costs associated with FILSPARI following the February 2023 accelerated approval.

At December 31, 2024, the Company's evaluation of excess inventory and obsolescence resulted in a $ 1.0 million charge to cost of goods sold and an equal write-down of inventory balances due to lower forecasted sales of the Company's tiopronin products.

For the year ended December 31, 2024, there were no charges recorded on FILSPARI inventory.

At December 31, 2023, the Company's evaluation of excess inventory and obsolescence considered certain minimum purchase obligations, which in combination with lower forecasted sales of FILSPARI resulted in a $ 3.2 million charge to cost of goods sold.

For the year ended December 31, 2023, the Company's evaluation of excess inventory and obsolescence considered certain minimum purchase obligations, which in combination with lower forecasted sales of FILSPARI resulted in a $ 3.2 million charge to cost of goods sold.

The charge to cost of goods of sold included a $ 2.1 million write-down of inventory balances and $ 1.1 million accrued for firm purchase commitments.

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The prepaid amounts are expensed as the related goods are delivered or the services are performed, or when it is no longer expected that the goods will be delivered or the services rendered.

During the three months ended December 31, 2022, the Company recorded an out of period adjustment that decreased research and development expenses and related accrued expenses by $ 7.7 million, $ 1.5 million of which was previously recorded in fiscal year 2022 and $ 6.2 million that was originally recorded in fiscal year 2021.

The adjustment was the result of a certain pre-launch inventory contract that was not properly evaluated for accounting implications at inception.

The Company evaluated the impact of the adjustment and concluded it is not material, individually and in the aggregate, to 2022 or any prior period financial statements.

Clinical Trial Expenses

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The Company currently has four Phase 3 clinical trials in process that are in varying stages of activity, with ongoing non-clinical support trials.

As such, clinical trial expenses will vary depending on all the factors set forth above and may fluctuate significantly from quarter to quarter.

As such, clinical trial expenses will vary depending on all the factors set forth above and may fluctuate significantly from quarter to quarter and year to year.

Advertising Expenses

Advertising costs are expensed as incurred.

The Company incurred $ 14.7 million, $ 7.8 million and zero in advertising costs during the years ended December 31, 2025, 2024 and 2023, respectively.

Share-Based Compensation

13 unchanged sentences

Pre-funded warrants issued and sold by the Company to purchase shares of its common stock are included in the calculation of basic net loss per common share if the exercise price of the pre-funded warrant represents little consideration and is non-substantive in relation to the price paid for the warrant, and if the warrants are immediately exercisable with no further vesting conditions or contingencies associated with them.

The Company's diluted earnings/(loss) per share computation includes the effect, if any, of shares that would be issuable upon the exercise of outstanding stock options, convertible debt and RSUs, reduced by the number of shares which are assumed to be purchased by the Company from the resulting proceeds at the average market price during the year, when such amounts are dilutive to the earnings per share calculation.

The treasury stock method reduces the number of shares issuable by the shares assumed to be purchased by the Company from the resulting proceeds at the average market price during the year, when such amounts are dilutive to the earnings/(loss) per share calculation.

As the Company has reported net losses for all periods presented, all potentially dilutive securities are antidilutive and, accordingly, basic net loss per share equals diluted net loss per share.

In accordance with ASC 260, Earnings per Share , if a company had a discontinued operation, the company uses income from continuing operations, adjusted for preferred dividend and similar adjustments, as its control number to determine whether potential common shares are dilutive.

Cash and Cash Equivalents

The Company considers all highly liquid marketable securities with an original maturity of three months or less to be cash equivalents.

The Company considers all highly liquid investments with an original maturity of three months or less to be cash equivalents.

Due to the short-term maturity of such investments, the carrying amounts are a reasonable estimate of fair value.

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The allowance for credit losses was zero at both December 31, 2025 and 2024, respectively.

For the years ended December 31, 2024, 2023 and 2022, bad debt expense recorded in the Consolidated Statements of Operations was immaterial.

For the years ended December 31, 2025, 2024 and 2023, provision for credit losses was immaterial.

The Company's evaluation of credit losses for the current period included an assessment of our aged trade receivables balances and their underlying credit risk characteristics.

Our evaluation of past events, current conditions, and reasonable and supportable forecasts about the future resulted in an expectation of immaterial credit losses.

As of December 31, 2025 the Company's accounts receivable balance includes a $ 25.0 million milestone payment from Mirum.

See Note 19 for further discussion.

Supplier Concentration Risk

The Company has no manufacturing capabilities and relies on third party manufacturers who are sole source suppliers for manufacturing of its products.

The Company intends to rely on third-party manufacturers for the long-term commercial supply of FILSPARI and for its development stage product candidates, including sparsentan for the treatment of FSGS and pegtibatinase.

The Company intends to rely on third-party manufacturers for the long-term commercial supply of Thiola and FILSPARI and for its development stage product candidates, including sparsentan for the treatment of FSGS and pegtibatinase.

The Company expects the manufacturers of each product or product candidate to, at least initially and potentially for a significant period of time, be single source suppliers to the Company.

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Costs determined to be variable and not based on an index or rate are not included in the measurement of the lease liability and are expensed as incurred.

The Company has made an accounting policy election to not recognize short-term leases, or leases that have a lease term of 12 months or less at commencement date, within its Consolidated Balance Sheets and to recognize those lease payments in the Consolidated Statements of Operations on a straight-line basis over the lease term.

The Company recognizes income from sublet office space on a straight-line basis over the term of the sublease, recorded in other income in the Consolidated Statements of Operations.

The Company recognizes income from sublet office space on a straight-line basis over the term of the sublease, recorded in other income in the Consolidated Statements of Operations and Comprehensive Loss.

Intangible Assets, Net

26 unchanged sentences

If the Company determines that it is no longer the primary beneficiary of a consolidated VIE, it deconsolidates the VIE in the period in which the determination is made.

Assets and liabilities recorded as a result of consolidating the financial results of the VIE into the Company’s consolidated balance sheet do not represent additional assets that could be used to satisfy claims against the Company’s general assets or liabilities for which creditors have recourse to the Company’s general assets.

Assets and liabilities recorded as a result of consolidating the financial results of the VIE into the Company’s Consolidated Balance Sheets do not represent additional assets that could be used to satisfy claims against the Company’s general assets or liabilities for which creditors have recourse to the Company’s general assets.

Equity Securities

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Basis differences relating to in-process research and development (IPR&D) are expensed when the investee is not considered a business as defined in ASC 805, Business Combinations, due to substantially all of the estimated fair value of the gross assets being concentrated in a group of similar IPR&D assets with no alternative future use.

For the year ended December 31, 2024, the Company recognized $ 3.4 million in other (expense) income, net in the Company's Consolidated Statements of Operations for these basis adjustments.

The equity method investment's carrying value was reduced to zero as the Company's proportionate share of the basis difference exceeded the carrying value.

For the year ended December 31, 2025, the Company did not record any basis adjustments.

For the year ended December 31, 2024, the Company recognized $ 3.4 million in other income (expense), net for these basis adjustments and reduced the equity method investment's carrying value to zero , as the Company's proportionate share of the basis difference exceeded the carrying value.

See Note 5 for further discussion.

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The Company evaluates its finite-lived intangible assets, right-of-use assets, and property and equipment for impairment whenever events or changes in circumstances indicate the carrying value of an asset or group of assets may not be recoverable.

If these circumstances exist, recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset group to future undiscounted net cash flows expected to be generated by the use and eventual disposition of the asset group.

If these circumstances exist, recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset group to future undiscounted net cash flows expected to

be generated by the use and eventual disposition of the asset group.

If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds the fair value of the assets.

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Foreign exchange gains and losses resulting from the settlement of such transactions and from the remeasurement at year-end exchange rates of monetary assets and liabilities denominated in foreign currencies are recognized within Other income (expense), net in the Consolidated Statements of Operations and Comprehensive Loss.

An aggregate loss of $ 0.7 million arising from foreign exchange transactions is included in other (expense) income, net for the year ended December 31, 2024.

An aggregate gain of $ 0.5 million and $ 1.4 million is included in other (expense) income, net for the years ended December 31, 2023 and 2022, respectively.

An aggregate loss of $ 0.3 million, $ 0.7 million and a gain of $ 0.5 million arising from foreign exchange transactions is included in other income (expense), net for the years ended December 31, 2025, 2024 and 2023, respectively.

The results and financial position of the Company that have a functional currency different from the U.S.

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The following table summarizes the foreign currency translation adjustment included in accumulated other comprehensive loss for the year ended December 31, 2025, 2024 and 2023 ( in thousands ):

Foreign Currency Translation Adjustments included in Accumulated Other Comprehensive (Loss) Gain

Foreign Currency Translation Adjustments included in Accumulated Other Comprehensive Loss

2025 2024 2023

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Certain reclassifications have been made to the prior year financial statements in order to conform to the current year’s presentation.

These reclassifications did not have an impact on total assets or total liabilities and stockholders' equity in the Consolidated Balance Sheets or net loss in the Consolidated Statements of Operations.

The Company expenses external costs, such as filing fees and associated attorney fees, incurred to obtain issued patents and patent applications pending.

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Discontinued operations is presented when there is a disposal of a component or a group of components that in the Company's judgment represents a strategic shift that will have a major effect on the Company's operations and financial results.

Results of operations directly related to discontinued operations are aggregated into a single line item in the Consolidated Statements of Operations for all periods presented.

Results of operations directly related to discontinued operations are aggregated into a single line item in the Consolidated Statements of Operations and Comprehensive Loss for all periods presented.

See Note 19 for further discussion.

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Restructuring costs were primarily comprised of one-time termination benefits, including severance, continuation of health insurance coverage, and other benefits for a specified period of time.

In 2024, we also recognized charges for impairment of operating lease right-of-use assets and related leasehold improvements, as well as disposal costs on furniture and fixtures associated with available office space that the Company has sublet as a result of the reduction in occupancy.

As of December 31, 2024, we are no longer incurring restructuring expenses.

Of the $ 13.8 million recognized to date, $ 2.4 million was recognized during the year ended December 31, 2024, including $ 1.2 million related to the impairment and disposal costs and initial direct costs to obtain the sublease.

The following table summarizes the cash payments and accruals, included in accrued expenses of the Consolidated Balance Sheets, related to the restructuring for the years ended December 31, 2024 and 2023 ( in thousands ):

The Company recognized $ 2.4 million during the year ended December 31, 2024, including $ 1.2 million related to the impairment of operating lease right-of-use assets and related leasehold improvements, as well as disposal costs associated with the sublease of office space.

As of December 31, 2024, the Company had recognized total costs of $ 13.8 million in connection with the restructuring and no such expenses were incurred for the year ended December 31, 2025.

The following table summarizes the cash payments and accruals, included in accrued expenses of the Consolidated Balance Sheets, related to the restructuring for the year ended December 31, 2024 ( in thousands ):

Liability balance at January 1, $ 11,421

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Recently Adopted Accounting Pronouncements

In November 2023, the FASB issued ASU No.

2023-07, Improvements to Reportable Segment Disclosures.

The FASB amended the guidance in ASC 280, Segment Reporting ("ASC 280"), to require a public entity to disclose significant segment expenses and other segment items on an annual and interim basis and to provide in interim periods all disclosures about a reportable segment's profit or loss and assets that are currently required annually.

Public entities with a single reportable segment are required to provide the new disclosures and all the disclosures required under ASC 280.

The guidance is applied retrospectively to all periods presented in financial statements, unless it is impracticable.

This new guidance is effective for public business entities for annual periods beginning after December 15, 2023, and for interim periods beginning after December 15, 2024.

The Company adopted this new standard effective December 31, 2024 .

See Note 20, Segment Information, for disclosures related to the adoption of ASU 2023-07.

In August 2020, the FASB issued ASU No.

2020-06, Accounting for Convertible Instruments and Contracts in an Entity's Own Equity.

The ASU includes amendments to the guidance on convertible instruments and the derivative scope exception for contracts in an entity's own equity in Subtopic 815-40 and simplifies the accounting for convertible instruments which include beneficial conversion features or cash conversion features by removing certain separation models in Subtopic 470-20.

Additionally, the ASU requires entities to use the "if-converted" method when calculating diluted earnings per share for convertible instruments.

The adoption of the new standard impacted the Company's accounting for its Convertible Senior Notes Due 2025 (2025 Notes), discussed in Note 7, which were previously accounted for using the cash conversion model applied under ASC 470-20, Debt with Conversion and Other Options ("ASC 470-20").

The Company adopted ASU 2020-06 on January 1, 2022 using the modified retrospective method.

The cumulative effect of the accounting change as of January 1, 2022 increased the carrying amount of the 2025 Notes by $ 44.7 million, reduced additional paid-in capital by $ 74.9 million, and reduced accumulated deficit by $ 30.2 million.

In December 2023, the FASB issued Accounting Standards Update ("ASU") No.

2023-09, Improvements to Income Tax Disclosures.

This ASU does not change accounting for income taxes but requires new disclosures focusing on two areas, the effective rate reconciliation and taxes paid.

The Company adopted the standard and applied the disclosure requirements on a prospective basis as required for the year ended December 31, 2025.

Recently Issued Accounting Pronouncements

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Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on its consolidated financial position or results of operations upon adoption.

In September 2025, the FASB issued ASU No.

2025-06—Intangibles—Goodwill and Other—Internal-Use Software (Subtopic 350-40):

Targeted Improvements to the Accounting for Internal-Use Software.

This ASU removed the language around project stages that was used to assess when costs could be capitalized for an internal-use software.

The update also requires internal-use software to be disclosed under the ASC 360 Property, Plant, and Equipment guidance.

The guidance is effective for annual periods beginning after December 15, 2027.

The Company is currently assessing the impact of this standard on the Company’s accounting policies and the financial statements.

In July 2025, the FASB issued ASU No.

2025-05—Financial Instruments—Credit Losses (Topic 326):

Measurement of Credit Losses for Accounts Receivable and Contract Assets.

This ASU added a practical expedient that assumes that current conditions as of the balance sheet date do not change for the remaining life of the asset when estimating expected credit losses for current accounts receivable and current contract assets.

The guidance is effective for annual periods beginning after December 15, 2025.

The Company is currently evaluating the impact of the adoption of this standard on the accounting for credit losses.

In November 2024, the FASB issued ASU No.

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This ASU clarifies the requirements for determining whether to account for certain early settlements of convertible debt instruments as induced conversions or extinguishments.

The guidance is effective for fiscal years beginning after December 15, 2025, with early adoption permitted for entities that have adopted 2020-06.

The guidance is effective for fiscal years beginning after December 15, 2025, with early adoption permitted for entities that have adopted ASU 2020-06.

The Company is currently evaluating the impact of the adoption of this standard on the accounting for the Company's convertible notes.

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For any remaining items within each relevant expense caption, entities must provide a qualitative description of the nature of those expenses.

The new ASU is effective for annual reporting periods beginning after December 15, 2026 and interim reporting periods beginning after December 15, 2027.

Early adoption is permitted.

The Company is currently evaluating the impact of the adoption of this standard on the related disclosures.

In December 2023, the FASB issued ASU No.

2023-09, Improvements to Income Tax Disclosures.

This ASU does not change accounting for income taxes but requires new disclosures focusing on two areas, the effective rate reconciliation and taxes paid.

This new standard is effective for public business entities for annual periods beginning after December 15, 2024.

The new ASU is effective, as clarified by ASU No.

2025-01, for annual reporting periods beginning after December 15, 2026 and interim reporting periods within annual reporting periods beginning after December 15, 2027.

Early adoption is permitted.

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Product sales consist of FILSPARI and tiopronin products (Thiola and Thiola EC).

The Company sells its products to specialty pharmacies and through direct-to-patient distributors worldwide, with the United States representing over 98 % of net product sales.

The Company sells its products to specialty pharmacies and through direct-to-patient distributors worldwide, with the United States representing over 98 % of the Company's net product sales.

The Company sells FILSPARI to two direct-to-patient specialty pharmacies in the United States.

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License Agreement with CSL Vifor

In September 2021, the Company entered into a license and collaboration agreement (“License Agreement”) with Vifor (International) Ltd.

(“CSL Vifor”), pursuant to which the Company granted an exclusive license to CSL Vifor for the commercialization of sparsentan in Europe, Australia and New Zealand ("Licensed Territories").

CSL Vifor also has first right of negotiation to expand the licensed territories into Canada, China, Brazil and/ or Mexico.

Under the terms of the License Agreement, the Company received an upfront payment of $ 55.0 million and will be eligible for up to $ 135.0 million in aggregate regulatory and market access related milestone payments and up to $ 655.0 million in aggregate sales-based milestone payments for a total potential value of up to $ 845.0 million.

The Company is also entitled to receive tiered double-digit royalties of up to 40 percent of annual net sales of sparsentan in the Licensed Territories.

Under the License Agreement, CSL Vifor is responsible for all commercialization activities in the Licensed Territories.

The Company remains responsible for the worldwide clinical development of sparsentan through regulatory approval as defined and will retain all rights to sparsentan in the United States and rest of world outside of the Licensed Territories.

In September 2021, the Company entered into the CSL Vifor License Agreement, pursuant to which the Company granted an exclusive license to CSL Vifor for the commercialization of FILSPARI in Europe, Australia and New Zealand.

In June 2025, the CSL Vifor License Agreement was amended in order to expand the license to cover additional countries ("CSL Vifor Licensed Territories") and to provide that the license rights to each additional country will revert to the Company if CSL Vifor does not take certain specified actions within specified timelines with respect to such country.

CSL Vifor also has first right of negotiation to expand the licensed territories into Canada and/or Mexico.

Under the terms of the CSL Vifor License Agreement, the Company received an upfront payment of $ 55.0 million and will be eligible for up to $ 135.0 million in aggregate regulatory and market access related milestone payments and up to $ 655.0 million in aggregate sales-based milestone payments for a total potential value of up to $ 845.0 million.

The Company is also entitled to receive tiered double-digit royalties of up to 40 percent of annual net sales of FILSPARI in the CSL Vifor Licensed Territories.

Under the License Agreement, CSL Vifor is responsible for all commercialization activities in the CSL Vifor Licensed Territories.

The Company remains responsible for the worldwide clinical development of sparsentan through regulatory approval as defined.

Development costs for any post regulatory approval development activities, subject to approval by both parties, will be borne by the Company and CSL Vifor as defined, respectively.

The License Agreement will remain in effect, unless terminated earlier, until the expiration of all royalty terms for sparsentan in the licensed territories.

Each party has the right to terminate the License Agreement for the other party’s uncured material breach, insolvency or if the time required for performance under the License Agreement by the other party is extended due to a force majeure event that continues for six months or more.

The Company assessed the License Agreement and determined that it meets both criteria to be considered a collaborative agreement within the Scope of ASC 808, Collaborative Arrangements of active participation by both parties and exposures to significant risks and rewards dependent on the commercial success of the activities.

The CSL Vifor License Agreement will remain in effect, unless terminated earlier, until the expiration of all royalty terms for FILSPARI in the CSL Vifor Licensed Territories.

Each party has the right to terminate the CSL Vifor License Agreement for the other party’s uncured material breach, insolvency or if the time required for performance under the CSL Vifor License Agreement by the other party is extended due to a force majeure event that continues for six months or more.

The Company assessed the CSL Vifor License Agreement and determined that it meets both criteria to be considered a collaborative agreement within the Scope of ASC 808, Collaborative Arrangements of active participation by both parties and exposures to significant risks and rewards dependent on the commercial success of the activities.

Both parties participate on joint steering and other committees overseeing the collaboration activities.

Also, both parties are exposed to significant risks and rewards based on the economic outcomes of regulatory approvals and commercialization of sparsentan.

The Company determined the transaction price under the License Agreement totaled $ 55.0 million, consisting of the fixed non-refundable upfront payment.

The variable regulatory and access related milestones were excluded from the transaction price given the substantial uncertainty related to their achievement.

The Company determined the initial transaction price under the CSL Vifor License Agreement totaled $ 55.0 million, consisting of the fixed non-refundable upfront payment.

The variable regulatory and access related milestones were considered variable consideration and excluded from the transaction price given the substantial uncertainty at inception related to their achievement, based on the most likely amount method.

Sales-based milestone payments and royalties on net sales were excluded from the transaction price and are recognized at the later of when the related sales occur or when the performance obligation to which the sales-based milestone or royalty has been allocated have been satisfied.

The Company concluded that CSL Vifor represented a customer and applied relevant guidance from ASC 606 to evaluate the accounting under the License Agreement.

In accordance with this guidance, the Company concluded that the promise to grant the license is distinct from the promise to provide clinical development services resulting in two performance obligations.

The Company re-evaluates the transaction price for each reporting period and as uncertainties are resolved.

The Company concluded that CSL Vifor represented a customer and applied relevant guidance from ASC 606 to evaluate the accounting under the CSL Vifor License Agreement.

In accordance with this guidance, the Company concluded at inception that the promise to grant the license is distinct from the promise to provide clinical development services resulting in two performance obligations.

As a result, the Company allocated $ 12.0 million of the transaction price, based on the performance obligations' relative standalone selling prices, to the license, which was recognized in full in 2021.

The remaining $ 43.0 million of the transaction price was allocated to the clinical development activities and recorded as deferred revenue, which are being recognized over the development period based upon the ratio of costs incurred to date to the total estimated costs.

For the year ended December 31, 2024, the Company recognized $ 5.8 million in license and collaboration revenue for clinical development activities, based upon the ratio of costs incurred to total estimated costs, and $ 0.6 million for royalties earned in 2024 on net sales of FILSPARI in the CSL Vifor Licensed Territories following the August 2024 launch.

For the year ended December 31, 2023, the Company recognized a total of $ 17.7 million in license and collaboration revenue, which consisted of $ 3.3 million from the sale of active pharmaceutical ingredients to CSL Vifor, and $ 14.4 million for clinical development activities, based upon the ratio of costs incurred to total estimated costs.

A decrease in total costs for clinical development activities due to the restructuring announced in December 2023 resulted in a $ 2.9 million increase in amortization of deferred revenue under the cost-to-cost model for the year ended December 31, 2023.

Deferred revenue related to the clinical development activities as of December 31, 2024 was $ 2.8 million, classified as current as the Company estimates that the remainder of the deferred revenue balance will be fully realized by mid-2025.

As of December 31, 2023, deferred revenue related

to the clinical development activities was $ 8.9 million, of which $ 7.1 million was classified as current.

The $ 1.8 million classified as non-current as of December 31, 2023 is included in other non-current liabilities in the Consolidated Balance Sheets.

The remaining $ 43.0 million of the transaction price was allocated to the clinical development activities and recorded as deferred revenue, which was recognized over the development period based upon the ratio of costs incurred to date to the total estimated costs through June 30, 2025.

For the year ended December 31, 2025, the Company achieved a market access milestone in the UK and European Union of $ 40.0 million and a regulatory milestone as a result of the European Commission granting standard MA approval of $ 17.5 million that were added to the transaction price under the most likely amount method and recognized in full.

For the years ended December 31, 2025, 2024 and 2023, royalties on net sales, recorded when the related sales occur, were $ 5.9 million, $ 0.6 million and zero , respectively.

For the years ended December 31, 2025, 2024 and 2023, the Company recognized $ 71.0 million, $ 6.5 million and $ 17.7 million, respectively, in license and collaboration revenue associated with the CSL Vifor License Agreement.

Deferred revenue related to the clinical development activities as of December 31, 2025 and 2024 was zero and $ 2.8 million, respectively, classified as current in the Consolidated Balance Sheets.

The following table sets forth a summary of changes in deferred revenue for the years ended December 31, 2025, 2024 and 2023 (in thousands) :

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Balance at December 31, $ — $ 2,815 $ 8,931

Licensing Agreement with Renalys

In January 2024, the license agreement (“Renalys License Agreement”) between the Company and Renalys Pharma, Inc.

(“Renalys”) came into effect.

Pursuant to the terms of the Renalys License Agreement, the Company granted an exclusive license to Renalys for the development and commercialization of sparsentan in Japan, South Korea, Taiwan and other specified Asian countries ("Renalys Licensed Territories").

Under the terms of the Renalys License Agreement, the Company received a non-refundable upfront payment and will be eligible to receive up to $ 120.0 million in aggregate development and sales-based milestones.

The Company is also entitled to receive tiered double-digit to mid-20 percent royalties of annual net sales of sparsentan in the Renalys Licensed Territories.

Licensing Agreement with Chugai

In January 2024, the Chugai License Agreement came into effect, pursuant to which, the Company granted an exclusive license to Renalys (which has since been merged with and into Chugai) for the development and commercialization of sparsentan in Japan and other specified Asian countries ("Chugai Licensed Territories").

In October 2025, the Chugai License Agreement was amended to remove certain specified countries from the Chugai Licensed Territories.

Under the terms of the Chugai License Agreement, the Company received a non-refundable upfront payment and will be eligible to receive up to $ 120.0 million in aggregate regulatory, development and sales-based milestones.

The Company is also entitled to receive tiered double-digit to mid-20 percent royalties of annual net sales of sparsentan in the Chugai Licensed Territories.

In addition, the Company received an option to purchase shares of common stock of Renalys (“Option Agreement”), which it exercised in January 2024.

The Company also has the option to purchase all equity securities of Renalys at any time prior to the top-line results of the Phase 3 trial in Japan (“Buyout Right”).

Under the Renalys License Agreement, Renalys will be responsible for all development and commercialization activities in the Renalys Licensed Territories.

The Renalys License Agreement will remain in effect, unless terminated earlier, until the expiration of all royalty terms for sparsentan in the Renalys Licensed Territories.

Each party has the right to terminate the Renalys License Agreement for the other party’s uncured material breach or insolvency, or if the time required for performance under the Renalys License Agreement by the other party is extended due to a force majeure event that continues for nine months or more.

Renalys may terminate the Renalys License Agreement for any reason upon prior written notice to the Company.

The Company may terminate the Renalys License Agreement if Renalys abandons development in Japan or South Korea prior to first commercial sales of sparsentan in either Japan or South Korea.

The Company concluded that Renalys represents a customer and applied relevant guidance from ASC 606 to evaluate the accounting under the Renalys License Agreement.

The Company determined the transaction price under the Renalys License Agreement totaled $ 8.3 million, consisting of the fixed non-refundable upfront payment, milestone payment and estimated fair value of the Option Agreement.

The variable development-related milestones were excluded from the transaction price given the substantial uncertainty related to their achievement.

The Company also had the option to purchase all equity securities of Renalys at any time prior to the top-line results of the Phase 3 trial in Japan (“Buyout Right”).

Under the Chugai License Agreement, Chugai is responsible for all development and commercialization activities in the Chugai Licensed Territories.

The Company will retain all rights to sparsentan in the United States and rest of world outside of the CSL Vifor Licensed Territories and Chugai Licensed Territories, provided that CSL Vifor has a right of negotiation to expand the licensed territories into Canada and/or Mexico.

The Chugai License Agreement will remain in effect, unless terminated earlier, until the expiration of all royalty terms for sparsentan in the Chugai Licensed Territories.

Each party has the right to terminate the Chugai License Agreement for the other party’s uncured material breach or insolvency, or if the time required for performance under the Chugai License Agreement by the other party is extended due to a force majeure event that continues for nine months or more.

Chugai may terminate the Chugai License Agreement for any reason upon prior written notice to the Company.

The Company may terminate the Chugai License Agreement if Chugai abandons development in Japan or South Korea prior to first commercial sales of sparsentan in either Japan or South Korea.

The Company assessed the Chugai License Agreement and determined that it meets both criteria to be considered a collaborative agreement within the Scope of ASC 808, Collaborative Arrangements of active participation by both parties and exposures to significant risks and rewards dependent on the commercial success of the activities.

Both parties participate on a joint steering committee overseeing the development and commercial activities.

Also, both parties are exposed to significant risks and rewards based on the economic outcomes of regulatory approvals and commercialization of sparsentan.

The Company determined the transaction price under the Chugai License Agreement totaled $ 8.3 million, consisting of the fixed non-refundable upfront payment, milestone payment and estimated fair value of the Option Agreement.

The variable development-related milestones were excluded from the transaction price given the substantial uncertainty related to their achievement under the most likely amount method.

Sales-based milestone payments and royalties on net sales were excluded from the initial transaction price and will be recognized at the later of when the related sales occur or when the performance obligation to which the sales-based milestone or royalty has been allocated has been satisfied.

In accordance with ASC 606, the Company concluded that the promise to grant the license is distinct, resulting in one performance obligation as the license has stand-alone functionally at contract inception.

The Buyout Right precludes transferring control of the license to Renalys under ASC 606 and the Company’s option to repurchase the common stock at a price greater than the original license premium results in accounting for the Renalys License Agreement as a financing arrangement.

The transaction price was recorded in other current liabilities, and will be recognized in revenue upon termination of the Buyout Right.

See Note 5 for further discussion of VIE’s.

The Company concluded that Chugai represents a customer and applied relevant guidance from ASC 606 to evaluate the accounting under the Chugai License Agreement.

In accordance with this guidance, the Company concluded that the promise to grant the license is distinct, resulting in one performance obligation as the license has stand-alone functionally at contract inception.

The Buyout Right precluded transferring control of the

license to Renalys under ASC 606 and the Company’s option to repurchase the common stock at a price greater than the original license premium results in accounting for the Chugai License Agreement as a financing arrangement.

The transaction price was recorded in other current liabilities as a result of the Buyout Right as of December 31, 2024.

During the year ended December 31, 2025, the Buyout Right was relinquished and the Company recognized the Renalys deferred revenue amount of $ 9.3 million in license and collaboration revenue.

See Note 5 for further discussion of VIEs.

VARIABLE INTEREST ENTITIES

Stock Purchase and Collaboration Agreement with PharmaKrysto

On March 8, 2022, the Company entered into a Collaboration Agreement with PharmaKrysto Limited (“PharmaKrysto”), a privately held pre-clinical stage company related to PharmaKrysto's early-stage cystinuria discovery program, and concurrently therewith entered into a Stock Purchase Agreement with PharmaKrysto (together, the "Agreements").

Pursuant to the terms of the Agreements, the Company paid PharmaKrysto's shareholders $ 0.6 million in cash to purchase 5 % of the outstanding common shares of PharmaKrysto and $ 0.4 million to PharmaKrysto as a one-time signing fee.

Under the Collaboration Agreement, the Company will fund all research and development expenses for the pre-clinical activities

associated with the cystinuria program, which are estimated to be approximately $ 5.0 million.

The Agreements require the Company to purchase an additional 5 % of the outstanding common shares for $ 1.0 million upon the occurrence of a specified pre-clinical milestone, and granted an option to the Company to purchase the remaining outstanding shares of PharmaKrysto for $ 5.0 million upon the occurrence of a subsequent pre-clinical milestone prior to expiration of the option on March 8, 2025.

If the Company elects to exercise the option, it would be required to perform commercially reasonable clinical diligence obligations.

In addition, it would be required to make cash milestone payments totaling up to an aggregate $ 16.0 million upon the achievement of certain development and regulatory milestones, plus tiered royalty payments of less than 4 % on future net sales of a product, if approved.

The Company has the right to terminate the Agreements and return the shares for a nominal price at any time upon 60 days’ notice, subject to survival of contingent obligations, if any.

The Company determined that PharmaKrysto is a VIE because it lacks the resources to conduct the cystinuria clinical program and the limitation on the residual returns through the Company's option to purchase the remaining outstanding shares.

The Company further concluded that it is the primary beneficiary of the VIE due to the Company's ultimate control over the research and development program, and its obligation, subject to continuation of the collaboration, to fund 100 % of research and development costs of the program pursuant to the terms of the Collaboration Agreement.

The upfront payments were expensed to research and development and other income (expense), net upon initial consolidation.

The consolidated assets and liabilities as of December 31, 2024 and 2023 were immaterial.

In March 2022, the Company entered into a Collaboration Agreement with PharmaKrysto Limited (“PharmaKrysto”), a privately held pre-clinical stage company and concurrently entered into a Stock Purchase Agreement (together, the "Agreements") whereby the Company acquired 5 % of the outstanding common shares of PharmaKrysto.

The Agreements granted the Company an option to purchase the remaining outstanding shares of PharmaKrysto for $ 5.0 million upon the occurrence of a subsequent pre-clinical milestone, which expired on March 8, 2025.

As the option was not exercised by the Company prior to expiration, the rights granted to the Company under the Agreements ceased, and the previously purchased common shares were transferred back to PharmaKrysto for immaterial consideration.

The Company deconsolidated PharmaKrysto as of March 8, 2025, resulting in an immaterial amount recognized in the Consolidated Statements of Operations and Comprehensive Loss for the year ended December 31, 2025.

The consolidated assets and liabilities as of December 31, 2024 were immaterial.

The results of operations were not significant for the years ended December 31, 2025, 2024 and 2023.

The Company is not required to provide additional funding other than the contractually required amounts disclosed above.

The creditors and beneficial holders of PharmaKrysto have no recourse to the general credit or assets of the Company.

Licensing Agreement with Renalys

In January 2024, the Renalys License Agreement between the Company and Renalys came into effect and the Company exercised its option to purchase shares of common stock of Renalys.

The Company determined that Renalys is a VIE as they could require additional funding to support development and commercial activities.

The Company has variable interests in Renalys, including an equity interest, Buyout Right and performance-related payments under the Renalys License Agreement that absorb variability from the performance of Renalys.

Licensing Agreement with Chugai

In January 2024, the Chugai License Agreement between the Company and Renalys (which has since been acquired by and merged into Chugai) came into effect and the Company exercised its option to purchase shares of common stock of Renalys.

The Company determined that Renalys was a VIE as they could require additional funding to support development and commercial activities.

The Company had variable interests in Renalys, including an equity interest, Buyout Right and performance-related payments under the Chugai License Agreement that absorb variability from the performance of Renalys.

In order to determine the primary beneficiary of Renalys, the Company evaluated its variable interest to identify if the Company had the power to direct the activities that most significantly impact the economic performance.

Based upon the capital structure, governing documents and overall business operations, the Company determined that it is not the primary beneficiary as it does do not have the power to direct the activities that most significantly impact the economic performance of Renalys and does not have an obligation to absorb losses.

As of December 31, 2024, the carrying amount of the liabilities related to the Company’s variable interests was $ 8.9 million, recorded in other current liabilities in the Company’s Consolidated Balance Sheets.

The Company’s maximum exposure to loss as of December 31, 2024 is zero .

The Company is not required to provide additional funding.

The creditors have no recourse to the general credit or assets of the Company.

Based upon the capital structure, governing documents and overall business operations, the Company determined that it was not the primary beneficiary as it did not have the power to direct the activities that most significantly impact the economic performance of Renalys and did not have an obligation to absorb losses.

The carrying amount of the liabilities related to the Company’s variable interests was zero and $ 8.9 million as of December 31, 2025 and 2024, respectively, included in other current liabilities in the Company’s Consolidated Balance Sheets.

During the year ended December 31, 2025, the Buyout Right was relinquished and the Company recognized the deferred revenue balance of $ 9.3 million in license and collaboration revenue.

In the fourth quarter of 2025, Renalys was acquired by and merged into Chugai.

The Company sold its equity interest in Renalys to Chugai as part of the acquisition and recognized a gain of $ 10.2 million in other income (expense), net.

MARKETABLE DEBT SECURITIES

The Company's marketable debt securities as of December 31, 2024 and 2023 were composed of available-for-sale commercial paper and corporate and government debt securities.

The Company's marketable debt securities as of December 31, 2025 and 2024 were composed of available-for-sale commercial paper, corporate debt securities, securities of government-sponsored entities and municipal bonds.

The primary objective of the Company’s investment portfolio is to preserve capital and liquidity while enhancing overall returns.

6 unchanged sentences

Securities of government-sponsored entities 9,993 35,025

Municipal bonds 5,003 —

Total available-for-sale marketable debt securities $ 229,761 $ 312,166

In addition to funding operations, the decrease in the marketable debt securities balance as of December 31, 2025 is due to the repayment of convertible notes in September 2025.

See Note 7 for further discussion.

The following is a summary of short-term marketable debt securities classified as available-for-sale as of December 31, 2025 ( in thousands ):

4 unchanged sentences

Corporate debt securities Less than 1 77,414 12 ( 33 ) 77,393

Securities of government-sponsored entities Less than 1 34,993 33 ( 1 ) 35,025

Municipal bonds Less than 1 5,000 3 — 5,003

Total maturity less than 1 year 145,388 35 ( 39 ) 145,384

Corporate debt securities 1 to 2 74,389 69 ( 74 ) 74,384

Securities of government-sponsored entities 1 to 2 10,000 — ( 7 ) 9,993

Total maturity 1 to 2 years 84,389 69 ( 81 ) 84,377

Total available-for-sale marketable debt securities $ 229,777 $ 104 $ ( 120 ) $ 229,761

6 unchanged sentences

Securities of government-sponsored entities Less than 1 34,993 33 ( 1 ) 35,025

Total maturity less than 1 year 249,247 90 ( 699 ) 248,638

Corporate debt securities 1 to 2 233,969 1,444 ( 174 ) 235,239

Securities of government-sponsored entities 1 to 2 24,718 106 ( 26 ) 24,798

Total maturity 1 to 2 years 258,687 1,550 ( 200 ) 260,037

Total available-for-sale marketable debt securities $ 311,798 $ 517 $ ( 149 ) $ 312,166

7 unchanged sentences

The portion of the unrealized loss related to factors other than credit losses is recognized in other comprehensive loss.

The following is a summary of available-for-sale marketable debt securities in an unrealized loss position with no credit losses reported as of December 31, 2024 ( in thousands ):

The following is a summary of available-for-sale marketable debt securities in an unrealized loss position with no credit losses aggregated by investment category and length of time those individual securities have been in a continuous unrealized loss position reported as of December 31, 2025 ( in thousands ):

Less Than 12 Months 12 Months or Greater Total

4 unchanged sentences

Total $ 140,753 $ 120 $ — $ — $ 140,753 $ 120

The following is a summary of available-for-sale marketable debt securities in an unrealized loss position with no credit losses reported as of December 31, 2023 ( in thousands ):

Less Than 12 Months 12 Months or Greater Total

11 unchanged sentences

Factors unknown to us at this time may cause actual results to differ and require adjustments to the Company’s estimates and assumptions in the future.

CONVERTIBLE NOTES PAYABLE

CONVERTIBLE DEBT

The composition of the Company’s convertible senior notes are as follows ( in thousands ):

3 unchanged sentences

2.50 % convertible senior notes due 2025

68,904 68,904

Unamortized debt issuance costs - 2.25 % convertible senior notes due 2029

1 unchanged sentence

Unamortized debt issuance costs - 2.50 % convertible senior notes due 2025

( 226 ) ( 543 )

Total convertible senior notes, net of unamortized debt discount and debt issuance costs $ 311,724 $ 378,988

4 unchanged sentences

Convertible Senior Notes Due 2029

On March 11, 2022, the Company completed a registered underwritten public offering of $ 316.3 million aggregate principal amount of 2.25 % Convertible Senior Notes due 2029 (“2029 Notes”), which includes $ 41.3 million aggregate principal amount of 2029 Notes sold pursuant to the full exercise of the underwriters’ option to purchase additional 2029 Notes.

exercise of the underwriters’ option to purchase additional 2029 Notes.

The Company issued the 2029 Notes under an indenture, dated as of September 10, 2018, as supplemented by the second supplemental indenture, dated as of March 11, 2022 (collectively, the “2029 Indenture”).

2 unchanged sentences

The Company received net proceeds from the issuance of the 2029 Notes of $ 306.4 million, after deducting commissions and offering expenses of $ 9.9 million.

At December 31, 2024, accrued interest on the 2029 Notes of $ 2.4 million is included in accrued expenses in the accompanying Consolidated Balance Sheets.

At December 31, 2025 and December 31, 2024 accrued interest on the 2029 Notes of $ 2.4 million is included in accrued expenses in the accompanying Consolidated Balance Sheets.

The 2029 Notes comprise the Company’s senior, unsecured obligations and are (i) equal in right of payment with the Company’s existing and future senior, unsecured indebtedness;

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The debt issuance costs are being amortized and recognized as additional interest expense over the expected life of the 2029 Notes using the effective interest method.

We determined the expected life of the debt is equal to the seven-year term of the 2029 Notes.

The Company determined the expected life of the debt is equal to the seven-year term of the 2029 Notes.

The effective interest rate on the 2029 Notes is 2.74 %.

The 2029 Notes are accounted for in accordance with ASC 470-20, Debt with conversion and Other Options (“ASC 470-20”) and ASC 815-40, Contracts in Entity’s Own Equity (“ASC 815-40”).

Under ASC 815-40, to qualify for equity classification (or nonbifurcation, if embedded) the instrument (or embedded feature) must be both (1) indexed to the issuer’s stock and (2) meet the requirements of equity classification guidance.

Based upon the Company’s analysis, it was determined that the 2029 Notes do not contain embedded features requiring recognition as derivatives and bifurcation, and therefore are measured at amortized cost and recorded as liabilities on the Consolidated Balance Sheets.

The 2029 Notes do not contain any financial or operating covenants or any restrictions on the payment of dividends, the issuance of other indebtedness or the issuance or repurchase of securities by the Company.

There were no events of default for the 2029 Notes at December 31, 2025.

The 2029 Notes are classified as long-term convertible debt on the Company's Consolidated Balance Sheets at December 31, 2025 and December 31, 2024.

Convertible Senior Notes Due 2025

On September 10, 2018, the Company completed a registered underwritten public offering of $ 276.0 million aggregate principal amount of 2.50 % Convertible Senior Notes due 2025 ("2025 Notes"), and entered into a base indenture and supplemental indenture agreement ("2025 Indenture") with respect to the 2025 Notes.

The 2025 Notes will mature on September 15, 2025, unless earlier repurchased, redeemed, or converted.

The 2025 Notes are senior unsecured obligations of the Company and bear interest at an annual rate of 2.50 %, payable semi-annually in arrears on March 15 and September 15 of each year, beginning on March 15, 2019.

The net proceeds from the issuance of the 2025 Notes were approximately $ 267.2 million, after deducting commissions and the offering expenses of $ 8.8 million payable by the Company.

At December 31, 2024, accrued interest of $ 0.5 million is included in accrued expenses in the accompanying Consolidated Balance Sheets.

The 2025 Notes comprise the Company’s senior, unsecured obligations and are (i) equal in right of payment with the Company’s existing and future senior, unsecured indebtedness;

(ii) senior in right of payment to the Company’s existing and future indebtedness that is expressly subordinated to the 2025 Notes;

(iii) effectively subordinated to the Company’s existing and future secured indebtedness, to the extent of the value of the collateral securing that indebtedness;

and (iv) structurally subordinated to all existing and future indebtedness and other liabilities, including trade payables.

Holders may convert their 2025 Notes at their option only in the following circumstances:

(1) during any calendar quarter commencing after the calendar quarter ending on December 31, 2018 (and only during such calendar quarter), if the last reported sale price per share of the Company’s common stock for each of at least 20 trading days, whether or not consecutive, during the period of 30 consecutive trading days ending on, and including, the last trading day of the immediately preceding calendar quarter exceeds 130 % of the conversion price on the applicable trading day;

(2) during the five consecutive business days immediately after any 10 consecutive trading day period (“measurement period”) if the trading price per $1,000 principal amount of 2025 Notes for each trading day of the measurement period was less than 98 % of the product of the last reported sale price per share of the Company’s common stock on such trading day and the conversion rate on such trading day;

(3) upon the occurrence of certain

corporate events or distributions on the Company’s common stock;

(4) if the Company calls the 2025 Notes for redemption;

and (5) at any time from, and including, May 15, 2025 until the close of business on the scheduled trading day immediately before the maturity date.

The Company will settle conversions by paying or delivering, as applicable, cash, shares of the Company’s common stock, or a combination of cash and shares of the Company’s common stock, at the Company’s election, based on the applicable conversion rate.

The initial conversion rate for the 2025 Notes is 25.7739 shares of the Company’s common stock per $1,000 principal amount of 2025 Notes, which represents an initial conversion price of approximately $ 38.80 per share.

If a “make-whole fundamental change” (as defined in the 2025 Indenture) occurs, then the Company will, in certain circumstances, increase the conversion rate for a specified period of time.

The 2025 Notes will be redeemable, in whole or in part, at the Company’s option at any time, and from time to time, on or after September 15, 2022 and, in the case of any partial redemption, on or before the 40th scheduled trading day before the maturity date, at a cash redemption price equal to the principal amount of the 2025 Notes to be redeemed, plus accrued and unpaid interest, if any, to, but excluding, the redemption date, but only if the last reported sale price per share of the Company’s common stock exceeds 130 % of the conversion price on each of at least 20 trading days during the 30 consecutive trading days ending on, and including, the trading day immediately before the date the Company sends the related redemption notice.

If a fundamental change (as defined in the 2025 Indenture) occurs, then, subject to certain exceptions, holders may require the Company to repurchase their 2025 Notes at a cash repurchase price equal to the principal amount of the 2025 Notes to be repurchased, plus accrued and unpaid interest, if any, to, but excluding, the fundamental change repurchase date.

In the event of conversion, holders would forgo all future interest payments, any unpaid accrued interest and the possibility of further stock price appreciation.

Upon the receipt of conversion requests, the settlement of the 2025 Notes will be paid pursuant to the terms of the 2025 Indenture.

In the event that all of the 2025 Notes are converted, the Company would be required to repay the principal amount and any conversion premium in any combination of cash and shares of its common stock at the Company’s option.

In addition, calling the 2025 Notes for redemption will constitute a “make-whole fundamental change."

The Company incurred approximately $ 8.8 million of debt issuance costs relating to the issuance of the 2025 Notes, which were recorded as a reduction to the 2025 Notes on the Consolidated Balance Sheets.

The debt issuance costs are being amortized and recognized as additional interest expense over the expected life of the 2025 Notes using the effective interest method.

The Company determined the expected life of the debt is equal to the seven-year term of the 2025 Notes.

The effective interest rate on the 2025 Notes is 2.98 %.

On March 11, 2022, the Company completed its repurchase of $ 207.1 million aggregate principal amount of 2025 Notes for cash, including accrued and unpaid interest, for a total of $ 213.8 million.

This transaction involved a contemporaneous exchange of cash between the Company and holders of the 2025 Notes participating in the issuance of the 2029 Notes.

Accordingly, we evaluated the transaction for modification or extinguishment accounting in accordance with ASC 470-50, Debt – Modifications and Extinguishments on a creditor-by creditor basis depending on whether the exchange was determined to have substantially different terms.

The repurchase of the 2025 Notes and issuance of the 2029 Notes were deemed to have substantially different terms based on the present value of the cash flows or significant difference between the value of the conversion option immediately prior to and after the exchange.

Therefore, the repurchase of the 2025 Notes was accounted for as a debt extinguishment.

The Company recorded a $ 7.6 million loss on extinguishment of debt on its Consolidated Statements of Operations for the year ended December 31, 2022, which included the write-off of related deferred financing costs of $ 3.4 million.

After giving effect to the repurchase, and as of December 31, 2024, the total remaining principal amount outstanding under the 2025 Notes was $ 68.9 million.

The 2025 and 2029 Notes are accounted for in accordance with ASC 470-20, Debt with conversion and Other Options (“ASC 470-20”) and ASC 815-40, Contracts in Entity’s Own Equity (“ASC 815-40”).

Based upon the Company’s analysis, it was determined that the 2025 Notes and the 2029 Notes do not contain embedded features requiring recognition as derivatives and bifurcation, and therefore are measured at amortized cost and recorded as liabilities on the Consolidated Balance Sheets.

The 2025 and 2029 Notes do not contain any financial or operating covenants or any restrictions on the payment of dividends, the issuance of other indebtedness or the issuance or repurchase of securities by the Company.

There were no events of default for the 2025 Notes or 2029 Notes at December 31, 2024.

The 2025 and 2029 Notes are classified on the Company's Consolidated Balance Sheets at December 31, 2024 as short-term and long-tern convertible debt, respectively.

After giving effect to the repurchase the total remaining principal amount outstanding under the 2025 Notes was $ 68.9 million.

On September 15, 2025, the 2025 Notes matured and the Company repaid the remaining principal amount outstanding of $ 68.9 million plus accrued interest.

Interest Expense

16 unchanged sentences

Financial instruments with carrying values approximating fair value include cash and cash equivalents, accounts receivable, and accounts payable, due to their short-term nature.

As of December 31, 2024 and 2023, the fair value of the Company's 2.50 % Convertible Senior Notes due 2025 was $ 68.2 million and $ 58.3 million, respectively.

As of December 31, 2025 and 2024, the fair value of the Company's 2.25 % Convertible Senior Notes due 2029, which were issued in 2022, was $ 448.3 million and $ 302.1 million, respectively.

As of December 31, 2024, the fair value of the Company's 2.50 % Convertible Senior Notes due 2025, now repaid, was $ 68.2 million.

The fair values were estimated utilizing market quotations and are considered Level 2.

13 unchanged sentences

The Company’s long-lived assets are measured at fair value on a nonrecurring basis when there are indicators of impairment and a loss is recognized.

During the year ended December 31, 2025, there were no impairments to long-lived assets.

During the year ended December 31, 2024, the Company recorded impairment charges of $ 1.2 million on right-of-use assets, property and equipment, and other capitalized assets as the fair value of the asset group was less than their carrying value.

7 unchanged sentences

As consideration for the license, the Company is required to make substantial payments upon the achievement of certain milestones, totaling up to $ 114.1 million.

Through December 31, 2024, the Company has capitalized $ 47.2 million for contractual milestones achieved under the Ligand License Agreement, including $ 5.8 million for the year ended December 31, 2024.

Through December 31, 2025, the Company has capitalized $ 47.2 million for contractual milestones achieved under the Ligand License Agreement.

Pursuant to the Ligand License Agreement, the Company is obligated to pay to Ligand (and Bristol-Myers Squibb Company ("BMS")) an escalating royalty between 15 % and 17 % of net sales of sparsentan, with payments due quarterly.

3 unchanged sentences

Mission License Agreement

In 2014, the Company entered into the Mission License Agreement with Mission in which the Company obtained an exclusive, royalty-bearing license to market, sell and commercialize Thiola (tiopronin) in the United States and Canada, and a non-exclusive license to use know-how relating to Thiola to the extent necessary to market Thiola.

The initial term of the license was 10 years.

The Company paid Mission an up-front license fee of $ 3.0 million and during the term of the agreement will pay the greater of $ 2.0 million, representing the guaranteed minimum royalty, or 20 % of the Company’s net sales of Thiola during each calendar year.

In November 2017, the Company amended its agreement with Mission to extend the term of the current exclusive U.S.

and Canada licensing agreement by an additional five years , to 2029.

The royalty rate and guaranteed minimum payment were also extended through the new agreement term.

Upon execution of the amendment, the Company capitalized an additional $ 5.9 million in intangible assets and recorded a guaranteed minimum liability for the same amount.

In November 2018, the Company amended its agreement with Mission to remove all territorial restrictions on our license.

As consideration for the expanded territory, the Company paid an up-front fee of $ 0.3 million and will pay the greater of $ 0.1 million, representing the guaranteed minimum, or 20 % of the Company's net sales of Thiola generated outside of the United States during each calendar year.

Upon execution of the amendment, the Company capitalized an additional $ 1.0 million in intangible assets and recorded a guaranteed minimum liability of $ 0.7 million related to this amendment.

In 2014, the Company entered into the Mission License Agreement in which the Company obtained an exclusive, royalty-bearing license to market, sell and commercialize Thiola (tiopronin) in the United States and Canada, and a non-exclusive license to use know-how relating to Thiola to the extent necessary to market Thiola.

The initial term of the license was 10 years and was subsequently amended through 2029.

The Company paid

Mission an up-front license fee of $ 3.0 million and during the term of the agreement will pay the greater of $ 2.1 million, representing the guaranteed minimum royalty, or 20 % of the Company’s net sales of Thiola during each calendar year.

The present value of guaranteed minimum royalties payable using a discount rate ranging from approximately 7 % to 11 % based on the Company’s then borrowing rate is $ 6.6 million and $ 8.2 million as of December 31, 2025 and 2024, respectively.

As of December 31, 2024, the guaranteed minimum royalty current and long-term liability was approximately $ 2.1 million and $ 6.1 million, respectively, and is recorded as Other Liability in the Consolidated Balance Sheets.

As of December 31, 2023, the guaranteed minimum royalty current and long-term liability was approximately $ 2.1 million and $ 7.6 million, respectively, and is recorded as Other Liability in the Consolidated Balance Sheets.

As of December 31, 2025, the guaranteed minimum royalty current and long-term liability was approximately $ 2.1 million and $ 4.5 million, respectively, and $ 2.1 million and $ 6.1 million, respectively, as of December 31, 2024, recorded in other current and non-current liabilities, respectively, in the Consolidated Balance Sheets.

The Company has capitalized $ 185.3 million related to the Thiola intangible asset which consists of the up-front license fee, professional fees, present value of the guaranteed minimum royalties and any additional payment obligations through December 31, 2025 in excess of minimum royalties.

In 2024 the Company added $ 15.4 million to the intangible asset related to royalties in excess of the minimum.

Consistent with all prior periods since Thiola was acquired, the Company has not accrued any liability for royalties in excess of the annual contractual minimum at December 31, 2024, as such royalties are not yet probable and estimable.

In 2025 the Company recorded $ 14.3 million to the intangible asset related to royalties in excess of the minimum.

Consistent with all prior periods since Thiola was acquired, the Company has not accrued any liability for future royalties in excess of the annual contractual minimum at December 31, 2025, as such royalties are not yet probable and estimable.

The cost of the milestone payments and royalty payments are being amortized to selling, general and administration on a straight-line basis through March 31, 2026.

Amortizable intangible assets as of December 31, 2025 ( in thousands ):

Useful Life Gross Carrying Amount Accumulated Amortization Net Book Value

Mission license 12 $ 171,025 $ ( 115,303 ) $ 55,722

Ligand license 11 $ 108,163 $ ( 13,645 ) $ 94,518

Mission license 12 185,304 ( 166,707 ) 18,597

Total amortizable intangible assets $ 293,467 $ ( 180,352 ) $ 113,115

1 unchanged sentence

Useful Life Gross Carrying Amount Accumulated Amortization Net Book Value

Mission license 12 $ 155,589 $ ( 77,311 ) $ 78,278

Ligand license 11 $ 53,268 $ ( 5,769 ) $ 47,499

Mission license 12 171,025 ( 115,303 ) 55,722

Total amortizable intangible assets $ 224,293 $ ( 121,072 ) $ 103,221

9 unchanged sentences

There were no impairments related to finite-lived intangible assets in the years ended December 31, 2025, 2024 and 2023.

As of December 31, 2024 and 2023, the Company had goodwill of $ 0.8 million.

For the years ended December 31, 2024, 2023 and 2022 there were no impairments to goodwill.

ACCRUED EXPENSES

1 unchanged sentence

Compensation related costs $ 41,515 $ 35,166

Research and development 16,090 26,006

Accrued royalties 12,309 6,991

Sales discounts, rebates, and allowances 30,595 10,585

Accrued royalties 22,703 12,309

Research and development 16,027 16,090

Selling, general and administrative 9,818 6,154

Transition services accrual 285 12,282

Accrued restructuring costs — 11,421

Miscellaneous accrued expenses 5,377 5,724

5 unchanged sentences

The Company acquired Orphan by purchasing all of the outstanding shares.

Under the Agreement, the Company has also agreed to make contingent cash payments up to an aggregate of $ 427.0 million based on the achievement of certain development, regulatory and commercialization events as set forth in the Agreement, as well as additional tiered mid-single digit royalty payments based upon future net sales of any pegtibatinase products in the U.S.

Under the stock purchase agreement, the Company has also agreed to make contingent cash payments up to an aggregate of $ 427.0 million based on the achievement of certain development, regulatory and commercialization events as set forth in the Agreement, as well as additional tiered mid-single digit royalty payments based upon future net sales of any pegtibatinase products in the U.S.

and Europe, subject to certain reductions as set forth in the Agreement, and a contingent payment in the event a pediatric rare disease voucher for any pegtibatinase product is granted.

15 unchanged sentences

Unallocated shares under the Prior Plans are no longer available for issuance under the Prior Plans, and have instead been added to the shares available for issuance under the 2018 Plan.

The 2018 Plan, as amended, and including the unallocated shares of the Prior Plans, provides for a total of 18.4 million shares to be issued, plus the Prior Plans' returning shares, if any, which become available for grant under the 2018 Plan from time to time.

The 2018 Plan, as amended, and including the unallocated shares of the Prior Plans, provides for a total of 22,384,114 shares to be issued, plus the Prior Plans' returning shares, if any, which become available for grant under the 2018 Plan from time to time.

Options issued under the 2018 Plan will generally expire ten years from the date of grant and vest over a four-year period.

As of December 31, 2024, there were approximately 5.7 million shares reserved for future issuance under the 2018 Plan.

As of December 31, 2025, there were 7,135,921 shares reserved for future issuance under the 2018 Plan.

2017 Employee Stock Purchase Plan

6 unchanged sentences

The 2017 ESPP is intended to qualify as an “employee stock purchase plan” under Section 423 of the Internal Revenue Code.

As of December 31, 2024, there were approximately 2,480,000 shares authorized and 1,004,889 shares reserved for future issuance under the 2017 ESPP.

As of December 31, 2025, there were 2,780,000 shares authorized and 1,089,373 shares reserved for future issuance under the 2017 ESPP.

Stock Options

22 unchanged sentences

Granted 1,484,200 $ 20.65

Forfeited and expired ( 2,076,808 ) 20.02 — —

Exercised ( 1,869,242 ) $ 18.63 $ 23,247

Forfeited and expired ( 656,860 ) $ 28.29

Outstanding at December 31, 2025 8,241,429 $ 19.91 5.89 $ 150,796

Vested and expected to vest at December 31, 2025 8,241,429 $ 19.91 5.89 $ 150,796

The aggregate intrinsic value of stock options exercised in the years ended December 31, 2024, 2023 and 2022 was $ 2.0 million, $ 1.4 million, and $ 5.1 million, respectively.

The following table summarizes our stock options exercisable at December 31, 2024, 2023 and 2022:

Weighted Average

Shares Underlying

Options Exercise

Price Remaining

Term (in years) Aggregate

Intrinsic Value

(in thousands)

Exercisable at December 31, 2025 5,813,961 $ 20.83 4.77 $ 101,064

Exercisable at December 31, 2023 7,942,964 $ 20.85 3.95 $ —

Exercisable at December 31, 2024 6,892,156 $ 22.11 4.46 $ 3,249

The aggregate intrinsic value of stock options exercised in the years ended December 31, 2025, 2024 and 2023 was $ 23.2 million, $ 2.0 million, and $ 1.4 million, respectively.

The weighted average grant date fair value of options granted was $ 12.86 , $ 5.10 , and $ 11.66 during the years ended December 31, 2025, 2024 and 2023, respectively.

18 unchanged sentences

Performance-based stock units ("PSUs") are subject to vest only if certain specified criteria are achieved.

A target number of shares is established for each award;

however, the actual number of shares that are issued when an award vests may range from zero to 200 % of the target amount depending upon the level of achievement of the applicable performance metric.

As of December 31, 2025, there was approximately $ 0.1 million of unrecognized compensation cost related to PSUs granted and deemed probable of vesting.

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2025 2024 2023

Shares Net (loss) income EPS Shares Net (loss) income EPS Shares Net (loss) income EPS

Shares Net (loss) income EPS Shares Net loss EPS Shares Net (loss) income EPS

Continuing operations 89,211,813 $ ( 50,261 ) $ ( 0.57 ) 78,888,861 $ ( 320,630 ) $ ( 4.07 ) 74,267,418 $ ( 376,333 ) $ ( 5.07 )

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The components of the provision for income taxes, in the Consolidated Statements of Operations are as follows ( in thousands ):

Year Ended December 31,

2025 2024 2023

6 unchanged sentences

Total tax provision $ 988 $ 120 $ 223

The following is a reconciliation of the statutory federal income tax rate to the Company’s effective tax rate expressed as a percentage of loss before income taxes:

2024 2023 2022

In July 2025 the One Big Beautiful Bill Act was signed into law, which enacts significant changes to U.S.

tax and related laws.

The legislation did not have a material impact on the Company's income tax expense for the year ended December 31, 2025, nor did it materially change the Company's effective income tax rate for 2025.

The effective income tax rate for the year ended December 31, 2025 differs from the statutory federal income tax rate as follows ( in thousands, except percentages ):

Amount Percentage

Statutory rate - federal $ ( 10,347 ) ( 21.00 ) %

State taxes, net of federal benefit* 701 1.42 %

Foreign tax effects

Statutory tax rate differences 5,831 11.83 %

Changes in valuation allowances 3,758 7.63 %

Other 207 0.42 %

Other foreign jurisdictions

Other ( 18 ) ( 0.04 ) %

Orphan drug credits ( 16,224 ) ( 32.93 ) %

Return to provision adjustments ( 2,517 ) ( 5.10 ) %

Changes in valuation allowances 16,275 33.03 %

Nontaxable or nondeductible items

Executive compensation 1,710 3.47 %

Share-based awards 1,246 2.53 %

Other 442 0.90 %

Change in unrecognized tax benefits ( 1,456 ) ( 2.96 ) %

Other adjustments

Return to provision adjustments and other true-ups 1,380 2.80 %

Effective tax rate $ 988 2.00 %

* State taxes in California, Michigan and New Jersey for 2025 made up the majority (greater than 50%) of the tax effect in this category.

The following is a reconciliation of the statutory federal income tax rate to the Company’s effective tax rate expressed as a percentage of loss before income taxes for the years ended December 31, 2024 and 2023 :

Statutory rate - federal ( 21.00 ) % ( 21.00 ) %

State taxes, net of federal benefit ( 1.55 ) % ( 3.19 ) %

Foreign rate differential 2.15 % 1.29 %

5 unchanged sentences

Return to provision adjustments and other true-ups ( 0.80 ) % 4.19 %

Adoption of ASU 2020-06 — % — % ( 3.54 ) %

Other 0.93 % 0.57 %

11 unchanged sentences

Operating lease liabilities 4,164 5,421

174A state only difference 2,397 —

Depreciation 602 435

Loan costs 117 153

Interest expense limitation — 1,679

Total deferred tax assets 374,043 348,614

12 unchanged sentences

The Company has recorded a valuation allowance of $ 370.6 million as of December 31, 2025 to reflect the estimated amount of deferred tax assets that may not be realized.

The Company increased its valuation allowance by $ 53.5 million for the year ended December 31, 2024, compared to a $ 2.7 million decrease for the year ended December 31, 2023.

The Company increased its valuation allowance by $ 26.5 million for the year ended December 31, 2025, compared to a $ 53.5 million increase for the year ended December 31, 2024.

As of December 31, 2025, the Company had available unused U.S.

6 unchanged sentences

As of December 31, 2025, the Company had Irish NOL carryforwards of $ 15.9 million which are fully offset by a valuation allowance and have an indefinite life.

The Company also had Swiss NOL carryforwards of $ 359.1 million which are fully offset by a valuation allowance and begin to expire in 2025, as well as Federal Act on Tax Reform and AHV Financing (“TRAF”) cantonal tax benefits of $ 526.2 million which expire in 2029.

The Company also had Swiss NOL carryforwards of $ 475.2 million which are fully offset by a valuation allowance and begin to expire in 2026, as well as Federal Act on Tax Reform and AHV Financing cantonal tax benefits of $ 526.2 million which expire in 2029.

The Company accounts for uncertain tax benefits in accordance with the provisions of ASC 740-10 of the Accounting for Uncertainty in Income Taxes .

1 unchanged sentence

To the extent unrecognized tax benefits are recognized at a time when a valuation allowance does not exist, the recognition of the $ 26.0 million tax benefit would reduce the effective tax rate.

The Company does not anticipate that the amount of unrecognized tax benefits as of December 31, 2024 will change materially within the following 12 months.

A reconciliation of the Company's unrecognized tax benefits for the years 2025, 2024 and 2023 is provided in the following table ( in thousands ):

5 unchanged sentences

Decrease in prior period positions ( 4,716 ) — ( 838 )

Decrease due to settlements with tax authorities — — ( 310 )

Balance as of December 31:

6 unchanged sentences

The Company did not recognize any interest or penalties for the year ended December 31, 2025, 2024 and 2023.

Interest and penalties for the year ended December 31, 2022 were less than $ 0.1 million.

The cash taxes paid by the Company for the years ended December 31, 2025, 2024 and 2023 were immaterial.

EQUITY OFFERINGS

5 unchanged sentences

The exercise price of each pre-funded warrant is $ 0.0001 per share of common stock.

The net proceeds to the Company from the offering, after deducting the

underwriting discounts and offering expenses, were approximately $ 215.8 million.

The net proceeds to the Company from the offering, after deducting the underwriting discounts and offering expenses, were approximately $ 215.8 million.

The pre-funded warrants were exercised in the third quarter of 2024, resulting in the issuance of 1.25 million shares of the Company's common stock.

1 unchanged sentence

In October 2024, the Company filed a prospectus supplement to the prospectus included in its registration statement on Form S-3 (File No.

333-281194), pursuant to which the Company may offer and sell, from time to time through Jefferies LLC, as agent (“Jefferies”), up to $ 100.0 million of common stock pursuant to an Amended and Restated Open Market Sale Agreement ("ATM Agreement") with Jefferies dated October 2024.

The Company did no t sell any shares under the ATM Agreement during the year ended December 31, 2024.

As of December 31, 2025, the Company has no t sold any shares under the ATM Agreement.

RETIREMENT PLAN

13 unchanged sentences

Computers and equipment 2,731 2,275

Construction-in-progress — 169

14,120 14,091

2 unchanged sentences

Depreciation expense for the years ended December 31, 2025, 2024 and 2023 was $ 1.5 million, $ 1.8 million and $ 2.2 million, respectively.

As of December 31, 2024, the Company had operating leases, including one operating lease with Kilroy Realty, L.P.

As of December 31, 2025, the Company had an operating lease with Kilroy Realty, L.P.

(the "Landlord") for office space located in San Diego, California, which was entered into in April 2019 and subsequently amended in May 2020.

1 unchanged sentence

The total right-of-use asset and lease liability at measurement were each offset by lease incentives associated with tenant improvement allowances totaling $ 7.9 million.

The initial term of the office lease ends in August 2028, and the Landlord has granted the Company an option to extend the term of the lease by a period of 5 years.

The initial term of the office lease ends in August 2028, and the Landlord has granted the Company an option to extend the term of the lease by a period of five years .

At lease inception, it was not reasonably certain that the Company will extend the term of the lease and therefore the renewal period has been excluded from the aforementioned right-of-use asset and lease liability measurements.

The measurement of the lease term occurs from the February 2021 occupancy date of the office space.

As of December 31, 2024, the Company also had an operating lease with Esprit Investments Limited for office space located in Dublin, Ireland, which was entered into in October 2022.

The initial term of the office lease ends in September 2027.

The lease provides the option to extend the term of the lease by a period of 5 years, although at lease inception, it was not reasonably certain that the Company will elect this option and therefore the renewal period has been excluded from the initial lease measurement.

Utilizing a discount rate equal to the Company's borrowing rate, the Company established a right-of-use asset and corresponding lease liability of $ 0.4 million.

During the year ended December 31, 2024, due to the decreased occupancy from the 2023 restructuring along with efforts to optimize a hybrid work model, the Company decided to reduce its use of office space located in San Diego, California.

In November 2024, the Company entered into a sublease of its 5th floor premises.

2 unchanged sentences

To measure the Company’s periodic sublease income, the Company elected to use a practical expedient under ASC 842 to aggregate non-lease components with the related lease components when (i) the timing and pattern of transfer for the non-lease components and the related lease components are the same and (ii) the lease components, if accounted for separately, would be classified as an operating lease.

Given the circumstances surrounding the 5th floor premises, the Company identified an indicator of impairment of the related operating lease right-of-use assets, property and equipment, and other capitalized assets and compared the carrying value of the asset group to an estimate of the future undiscounted cash flows expected to result from the sublease and eventual disposition of the asset group.

During the year ended December 31, 2024, the Company identified an indicator of impairment of the 5th floor operating lease right-of-use assets, property and equipment, and other capitalized assets and compared the carrying value of the asset group to an estimate of the future undiscounted cash flows expected to result from the sublease and eventual disposition of the asset group.

The sum of the undiscounted cash flows of the asset group was below the carrying value.

Consequently, the Company utilized the present value of the estimated future cash flows attributable to the assets to determine the fair value of the asset group.

The resulting fair value of the operating lease right-of-use assets, property and equipment, and other capitalized assets resulted in an impairment of $ 1.2 million recorded in restructuring expense in the Consolidated Statements of Operations and categorized the aforementioned measurement of fair value as Level 3 within the ASC Topic 820, "Fair Value Measurements" fair value hierarchy.

The resulting fair value of the operating lease right-of-use assets, property and equipment, and other capitalized assets resulted in an impairment of $ 1.2 million recorded in restructuring expense and categorized the aforementioned measurement of fair value as Level 3 within the ASC Topic 820, "Fair Value Measurements" fair value hierarchy.

There were no impairments related to right-of-use assets or property and equipment in the years ended December 31, 2025 and 2023.

1 unchanged sentence

December 31, 2025

2029 and thereafter —

Total undiscounted future minimum payments 18,535

15 unchanged sentences

The Company will recognize the contingent consideration receivable in earnings when the target annual sales for the milestones are met and the contingency is resolved.

Mirum achieved the first such milestone based on its annual net sales in 2025, and Travere recognized a milestone of $ 25.0 million for the year ended December 31, 2025 in discontinued operations.

The $ 25.0 million is included in accounts receivable as of December 31, 2025.

The Company's sale of the bile acid business resulted in a gain, net of tax, of $ 226.0 million, which was recognized in 2023.

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The TSA is designed to ensure and facilitate an orderly transfer of business operations, and the consideration to be received by the Company primarily consists of cost reimbursement.

For the years ended December 31, 2024 and 2023, the Company recognized $ 0.5 million and $ 1.0 million, respectively, under the TSA, included in continuing operations within other income (expense), net.

As of December 31, 2024, the Company collected $ 1.5 million.

The uncollected balance is included in accounts receivable of the Consolidated Balance Sheets.

As part of the TSA, the Company is collecting certain receivables related to purchased assets for a period of time and remitting them to Mirum.

The transition services accrual as of December 31, 2024 was $ 0.3 million, and is included in accrued expenses in the accompanying Consolidated Balance Sheets.

TSA services provided by the Company are substantially complete as of December 31, 2024.

For the year ended December 31, 2024, the Company recognized $ 0.5 million, under the TSA, included in continuing operations within other income (expense), net.

TSA services provided by the Company were substantially complete as of December 31, 2024.

The Company determined that the divestiture represents a strategic shift that will have a major effect on the Company's operations and financial results, and has therefore reflected the bile acid business as a discontinued operation for all periods presented.

3 unchanged sentences

Net product sales $ — $ ( 550 ) $ 66,164

Total revenue ( 550 ) 66,164 102,558

Operating expenses:

4 unchanged sentences

Total operating expenses — 365 27,044

Operating income ( 915 ) 39,120 53,247

Other income (expenses), net:

Operating (loss) income — ( 915 ) 39,120

Other income, net:

Interest expense — — ( 191 )

Gain on disposal of discontinued operations, net of tax 24,715 — 226,005

Total other income (expense), net — 225,814 ( 261 )

(Loss) income from discontinued operations before income tax ( 915 ) 264,934 52,986

Income tax on discontinued operations — — —

Net (loss) income from discontinued operations $ ( 915 ) $ 264,934 $ 52,986

Total other income, net 24,715 — 225,814

Net income (loss) from discontinued operations $ 24,715 $ ( 915 ) $ 264,934

SEGMENT INFORMATION

3 unchanged sentences

The Company’s CODM also utilizes the Company’s long-range plan as a strategic tool to allocate resources according to the Company’s strategic objectives.

The Company sells its products to specialty pharmacies and through direct-to-patient distributors worldwide.

Net product sales outside of the United States ("U.S.") were not significant for the years ended December 31, 2024, 2023 and 2022.

Long-lived assets located outside the U.S.

were $ 4.5 million as of December 31, 2024.

The Company had no long-lived assets located outside the U.S.

as of December 31, 2023.

were immaterial as of December 31, 2025 and 2024.

The measure of segment assets is reported on the Consolidated Balance Sheets as total assets.

The accounting policies of the segment are the same as those described in Note 2, Summary of Significant Accounting Policies.

See Note 3 for further discussion of net product sales and Note 4 for discussion of license and collaboration revenues.

The following table presents reportable segment loss, including significant expenses regularly provided to the CODM, attributable to the Company’s reportable segment for the years ended December 31, 2025, 2024 and 2023 ( in thousands ):

11 unchanged sentences

Restructuring — 2,438 11,394

Total other income (expense), net 3,317 12,028 ( 11,342 )

Total other income, net 13,551 3,317 12,028

Income tax provision on continuing operations ( 988 ) ( 120 ) ( 223 )

(Loss) income from discontinued operations, net of tax ( 915 ) 264,934 52,986

Income (loss) from discontinued operations, net of tax 24,715 ( 915 ) 264,934

Net loss $ ( 25,546 ) $ ( 321,545 ) $ ( 111,399 )

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 9A. Controls and Procedures