What changed in this filing

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Item 9A. Controls and Procedures

2025-02-21 compared with 2024-02-20 · 432 added, 361 removed, 1414 unchanged (36% of the section changed)

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Internal control over financial reporting cannot provide absolute assurance of achieving financial reporting objectives because of its inherent limitations.

Internal control over financial reporting is a process that involves human diligence and compliance and is subject to lapses in judgment and breakdowns resulting from human failures.

Internal control over financial reporting is a process that involves human diligence and compliance and is subject to lapses in judgment

and breakdowns resulting from human failures.

Internal control over financial reporting also can be circumvented by collusion or improper management override.

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An evaluation was also performed under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, of any change to our internal control over financial reporting that occurred during the fourth quarter of 2024 and that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

As disclosed in Part II, Item 9A of the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, our Chief Executive Officer and Chief Financial Officer concluded that our internal control over financial reporting was not effective as of December 31, 2022 due to the following material weakness:

We did not design effective controls and procedures to evaluate the accounting for a certain pre-launch inventory contract affecting the timing of recognition of research and development expense.

Such material weakness did not result in a restatement of previously issued annual consolidated financial statements or interim consolidated financial statements.

The material weakness has been fully remediated as of December 31, 2023 and as of the date of this report.

Other than the aforementioned material weakness remediation, there have not been any changes in our internal control over financial reporting during the quarter ended December 31, 2023 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

There have not been any changes in our internal control over financial reporting during the quarter ended December 31, 2024 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Report of Independent Registered Public Accounting Firm

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and subsidiaries (the Company) maintained, in all material respects, effective internal control over financial reporting as of December 31, 2024, 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 sheet of the Company as of December 31, 2023, the related consolidated statements of operations and comprehensive loss, stockholders’ equity and cash flows for the year ended December 31, 2023, and the related notes and our report dated February 20, 2024 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, 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.

Basis for Opinion

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Trading Arrangements

None of the Company’s directors or officers adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement during the quarter ended December 31, 2023.

There are no other items required to be disclosed.

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:

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)

Timothy Coughlin ,

member of our Board of Directors

November 15, 2024 Rule 10b5-1 Trading Arrangement Up to 40,000 shares (3)

March 31, 2025

chair of our Board of Directors

December 17, 2024 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)

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”).

2 Each trading arrangement permits transactions through and including the earlier to occur of (a) the completion of all sales and (b) the date listed in the table.

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:

DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS

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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 CatalYm GmbH, a privately-held Germany based biotechnology company.

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.

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Since November 2023, Dr.

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

Previously, from May 2019 to Decem ber 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.

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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 and developed during his tenure at Neurocrine from 2002 to 2018.

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

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.

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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), and for Reneo Pharmaceuticals, Inc., a clinical stage pharmaceutical company

focused on the development and commercialization of therapies for patients with rare genetic mitochondrial diseases.

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, and on the Board of Directors for Biocom California.

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.

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

Previously, Mr.

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

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

Lyons currently serves on the Board of Directors of Rigel Pharmaceuticals, Inc., a biotechnology company focused on developing drugs for the treatment of inflammatory/autoimmune and metabolic diseases.

Previously, Mr.

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

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

(formerly known as Brickell Biotech, Inc.) from August 2019 to September 2023.

(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.

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

Since April 2018, Mr.

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

From June 2013 through June 2017, Mr.

Orwin served as Chief Executive Officer of Relypsa, Inc.

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

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.

Previously, Mr.

Orwin served as Vice President and then Senior Vice President of the BioOncology Business Unit at Genentech, Inc.

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

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.

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(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 (formerly Syncopation Life Sciences), a biotechnology company, and as the Chair of the Board of Directors for AnaptysBio, Inc., a clinical-stage biotechnology company, and as the Chair of the Board of Directors of the privately held company Nested Therapeutics which is focused on precision oncology medicine.

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 to December 2023, the board of directors of NeurogesX, Inc., and on the board of directors of Array BioPharma 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.

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Since July 2020, Ms.

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

Prior to Mythic, Ms.

Poole served as the Chief Operating Officer of LogicBio Therapeutics, Inc., a genome editing company from April 2018 to March 2019, and of Candel Therapeutics, a biotechnology company, from January 2020 to March 2020.

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 held executive roles of increasing responsibility at ImmunoGen, Inc., a company developing antibody-drug conjugates (ADCs) to treat cancer, including serving as Senior Vice President of Technical Operations from September 2014 to July 2015, Executive Vice President, Technical Operations from July 2015 to October 2016 and Executive Vice President, Technical Operations and Commercial Development from October 2016 to January 2017.

From February 2017 to March 2018 Ms.

Poole served as managing director of S.E.P.

Life Sciences Consulting LLC (formerly S.

Poole Consulting LLC), a biopharmaceutical consulting company.

Before joining ImmunoGen, Ms.

Poole spent more than 15 years in CMC product development and manufacturing leadership positions at Genzyme (now Sanofi), ultimately becoming SVP of Biologics Manufacturing, overseeing global manufacturing of six commercial products across five manufacturing sites in the US and EU.

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 vaccine company, and on the Board of Directors of ViaCyte, a privately held biotechnology until its acquisition by Vertex Pharmaceuticals Incorporated in July of 2022.

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 (Canada).

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

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

Since June 2023, Mr.

Squarer has served as Chair of the Board of Directors of Deciphera Pharmaceuticals, Inc., a commercial-stage biopharmaceutical company, where he has served as a Director since December 2019.

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

company, since March 2020.

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.

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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 not for profit Boards of DePaul University in Chicago, Illinois, and Allina Health.

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.

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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.

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.

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In addition, we intend to promptly disclose on our website in the future (i) the date and nature of any amendment (other than technical, administrative or other non-substantive amendments) to the policy that applies to our principal executive officer, principal financial officer, principal accounting officer or controller, or persons performing similar functions and relates to any element of the code of ethics definition enumerated in Item 406(b) of Regulation S-K, and (ii) the nature of any waiver, including an implicit waiver, from a provision of the policy that is granted to one of these specified individuals that relates to one or more of the elements of the code of ethics definition enumerated in Item 406(b) of Regulation S-K, the name of such person who is granted the waiver and the date of the waiver.

We have adopted insider trading policies and procedures governing the purchase, sale, and other dispositions of our securities by our directors, officers and employees, as well as Travere itself, that are reasonably designed to promote compliance with insider trading laws, rules and regulations, and listing standards applicable to Travere.

EXECUTIVE COMPENSATION

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

1.1 Open Market Sales Agreement, dated February 24, 2020, by and between the Company and Jefferies LLC.

(incorporated by reference to Exhibit 1.1 to the Company's Annual Report on Form 10-K filed with the SEC on February 24, 2020).

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).

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Bank Trust Company, National Association, as Trustee (including the form of 2.25% Convertible Senior Note due 2029) (incorporated by reference to Exhibit 4.2 to the Company's Current Report on Form 8-K, filed with the SEC on March 11, 2022).

4.6 Form of Pre-Funded Warrant (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K, filed with the SEC on March 1, 2023).

10.1 Form of Indemnity Agreement (incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q, filed with the SEC on May 1, 2018).

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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 .

10.9† The Company’s 202 3 Executive Officer Annual Bonus Plan (incorporated by reference to Exhibit 10.1 2 to the Company’s Annual Report on Form 10-K, filed with the SEC on February 2 3 , 202 3 ).

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).

10.9† The Company's 2025 Executive Officer Annual Bonus Plan.

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10.23* Amendment No.

5 to Sublicense Agreement dated as of March 20, 2018, between the Company and Ligand Pharmaceuticals Incorporated (incorporated by reference to Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q, filed with the SEC on May 1, 2018).

10.25∞ Trademark License and Supply Agreement, dated May 29, 2014, by and between the Company and Mission Pharmacal Company.

5 to Sublicense Agreement dated as of March 20, 2018, between the Company and Ligand Pharmaceuticals Incorporated (incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q, filed with the SEC on October 31, 2024).

10.24* Trademark License and Supply Agreement, dated May 29, 2014, by and between the Company and Mission Pharmacal Company (incorporated by reference to Exhibit 10.25 to the Company's Annual Report on Form 10-K, filed with the SEC on February 20, 2024).

10.25 First Amendment to Trademark License and Supply Agreement, effective as of July 28, 2014, by and between Mission Pharmacal Company and the Company (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K, filed with the SEC on July 29, 2014).

10.26 Addendum to Trademark License and Supply Agreement, dated October 19, 2015, by and between to Company and Mission Pharmacal (incorporated by reference to Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q, filed with the SEC on November 6, 2015).

10.28∞ Third Amendment to Trademark License and Supply Agreement dated as of March 17, 2016, between the Company and Mission Pharmacal Company.

10.29∞ Amendment One to the Third Amendment to Trademark License and Supply Agreement, dated September 12, 2016, by and between the Company and Mission Pharmacal Company.

10.30∞ Amendment Two to the Third Amendment to Trademark License and Supply Agreement, dated November 3, 2017, by and between the Company and Mission Pharmacal Company.

10.27* Third Amendment to Trademark License and Supply Agreement dated as of March 17, 2016, between the Company and Mission Pharmacal Company (incorporated by reference to Exhibit 10.28 to the Company's Annual Report on Form 10-K, filed with the SEC on February 20, 2024).

10.28* Amendment One to the Third Amendment to Trademark License and Supply Agreement, dated September 12, 2016, by and between the Company and Mission Pharmacal Company (incorporated by reference to Exhibit 10.29 to the Company's Annual Report on Form 10-K, filed with the SEC on February 20, 2024).

10.29* Amendment Two to the Third Amendment to Trademark License and Supply Agreement, dated November 3, 2017, by and between the Company and Mission Pharmacal Company (incorporated by reference to Exhibit 10.30 to the Company's Annual Report on Form 10-K, filed with the SEC on February 20, 2024).

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).

10.32∞ Fifth Amendment to Trademark License and Supply Agreement dated as of September 30, 2020, between the Company and Mission Pharmacal Company .

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 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.

21.1 List of subsidiaries of the Company.

23.1 Consent of Ernst & Yo ung .

23.1 Consent of Ernst & Young.

23.2 Consent of BDO USA, P.C.

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32.2 Chief Financial Officer’s Certification pursuant to Section 906 of Sarbanes Oxley Act of 2002.

97 Incentive Compensation Recoupment Policy

97 Incentive Compensation Recoupment Policy (incorporated by reference to Exhibit 97 to the Company's Annual Report on Form 10-K, filed with the SEC on February 20, 2024).

101.INS Inline XBRL Instance Document.

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* Certain portions of this exhibit are omitted pursuant to Item 601(b)(10)(iv).

∞ Certain confidential information contained in this Exhibit, marked in brackets, has been omitted, because it is both not material and of the type of information that the registrant treats as private or confidential.

FORM 10-K SUMMARY

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Timothy Coughlin February 20, 2025

/s/ Gary Lyons Director

/s/ Gary Lyons Chair of the Board

Gary Lyons February 20, 2025

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To the Stockholders and the Board of Directors of Travere Therapeutics, Inc.

Opinion on the Consolidated Financial Statements

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

and subsidiaries (the Company) as of December 31, 2023, the related consolidated statements of operations and comprehensive loss, stockholders’ equity and cash flows for the year ended December 31, 2023 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, 2023, and the results of its operations and its cash flows for the year ended December 31, 2023, in conformity with U.S.

Opinion on the Financial Statements

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.

generally accepted accounting principles.

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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.

We conducted our audits 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 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 financial statements, whether due to error or fraud, and performing procedures that respond to those risks.

Our audits included performing procedures to assess the risks of material misstatement of the 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 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 financial statements.

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

Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements.

We believe that our audits provide a reasonable basis for our opinion.

Critical Audit Matter

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Description of the Matter

As described in Note 3 to the consolidated financial statements under the caption “Deductions from Revenue”, the Company calculates the rebates that it will be obligated to provide to government programs and deducts these estimated amounts from its gross product sales at the time the revenues are recognized.

As described in Note 3 to the consolidated financial statements under the caption “Deductions from Revenue”, the Company calculates the rebates for Filspari that it will be obligated to provide to government programs and deducts these estimated amounts from its gross product sales at the time the revenues are recognized.

Allowances for government rebates and discounts are established based on an estimated allocation of payers and the government-mandated discounts applicable to government-funded programs.

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Estimated government rebates are included in accrued expenses on the consolidated balance sheet.

Auditing the government rebate deductions from revenue was complex and required significant auditor judgment because the related accruals were dependent on certain subjective assumptions.

Auditing the Filspari government rebate deductions from revenue was complex and required significant auditor judgment because the related accruals were dependent on certain subjective assumptions.

Such subjective assumptions included estimated allocations of payers and estimated government-mandated discounts applicable to government-funded programs, each of which are adjusted for the Company’s historical experience, current statutory requirements and specific known market events and trends, where appropriate.

How We Addressed the Matter in Our Audit

We obtained an understanding, evaluated the design, and tested the operating effectiveness of controls over the Company’s government rebate deductions from revenue process.

This included testing controls over management’s review of the significant assumptions described above and inputs into the rebate calculations.

For example, we tested controls over actual product sales and the accuracy of forecasting estimated allocations of payers.

The testing was inclusive of management’s controls to evaluate the accuracy of its judgments when compared to actual rebates paid, rebate validation and processing, and controls to ensure that the data used to evaluate and support the significant assumptions was complete, accurate and, where applicable, verified to external data sources.

To test the government rebate deductions from revenue, our audit procedures included, among others, understanding and evaluating the significant assumptions and underlying data used in management’s calculations.

Our testing of significant assumptions included a lookback analysis to evaluate the historical accuracy of management’s estimates by comparing actual activity to previous estimates and performed sensitivity analyses over the subjective assumptions to evaluate the completeness of the reserves.

As a part of our procedures, we evaluated the reasonableness of the Company’s assumptions considering recent sales trends and regulatory factors related to government rebates.

We obtained an understanding, evaluated the design, and tested the operating effectiveness of controls over the Company’s Filspari government rebate deductions from revenue process.

This included testing controls over management’s review of the significant assumptions described above and other inputs into the estimation of government rebates including the accuracy of data used in the calculation.

To test the Filspari government rebate deductions from revenue, our audit procedures included, among others, understanding and evaluating the significant assumptions and underlying data used in management’s calculations.

Our testing of significant assumptions included a lookback analysis to evaluate the historical accuracy of management’s estimates by comparing actual activity to previous estimates and performing sensitivity analyses over the subjective assumptions to evaluate the completeness of the reserves.

As a part of our procedures, we evaluated the reasonableness of the Company’s assumptions considering recent sales trends and regulatory factors related to Filspari government rebates.

/s/ Ernst & Young LLP

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Opinion on the Consolidated Financial Statements

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

(the “Company”) as of December 31, 2022, and 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, 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 financial position of the Company at December 31, 2022, and the results of its operations and its cash flows for each of the two years in the periods ended December 31, 2022, in conformity with accounting principles generally accepted in the United States of America.

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

4 unchanged sentences

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 audits.

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 audits in accordance with the standards of the PCAOB.

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

Our audits 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.

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 audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements.

We believe that our audits provide a reasonable basis for our opinion.

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.

1 unchanged sentence

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.

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.

7 unchanged sentences

Accounts receivable, net 27,116 21,179

Inventory, net 9,410 4,523

Inventory 6,200 9,410

Prepaid expenses and other current assets 12,685 19,335

Current assets of discontinued operations — 2,990

Total current assets 416,702 616,775

Long-term inventory, net 31,494 —

Long-term inventory 35,656 31,494

Property and equipment, net 5,336 7,479

2 unchanged sentences

Other assets 18,162 10,661

Non-current assets of discontinued operations — 48,342

Total assets $ 594,125 $ 788,913

3 unchanged sentences

Accrued expenses 86,028 118,991

Convertible debt, current portion 68,678 —

Deferred revenue, current portion 2,815 7,096

1 unchanged sentence

Other current liabilities 14,291 5,237

Current liabilities of discontinued operations — 7,000

Total current liabilities 200,751 177,908

Convertible debt 377,263 375,545

Deferred revenue, less current portion 1,835 10,931

Convertible debt, less current portion 310,310 377,263

Operating lease liabilities, less current portion 17,191 22,612

Other non-current liabilities 6,796 10,320

Non-current liabilities of discontinued operations — 64,200

Total liabilities 535,048 588,103

26 unchanged sentences

Selling, general and administrative 264,119 265,542 197,520

In-process research and development 65,205 — —

Restructuring 2,438 11,394 —

1 unchanged sentence

Operating loss ( 323,827 ) ( 388,138 ) ( 319,813 )

Other income (expenses), net:

Other income (expense), net:

Interest income 17,817 21,768 6,276

Interest expense ( 11,182 ) ( 11,334 ) ( 11,014 )

Other income, net 1,594 974 231

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

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

3 unchanged sentences

Loss from continuing operations, net of tax ( 320,630 ) ( 376,333 ) ( 331,468 )

Income from discontinued operations, net of tax 264,934 52,986 37,201

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

Net loss $ ( 321,545 ) $ ( 111,399 ) $ ( 278,482 )

2 unchanged sentences

Net loss from continuing operations $ ( 4.07 ) $ ( 5.07 ) $ ( 5.20 )

Net income from discontinued operations 3.57 0.83 0.62

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

Net loss per common share $ ( 4.08 ) $ ( 1.50 ) $ ( 4.37 )

2 unchanged sentences

Net loss $ ( 321,545 ) $ ( 111,399 ) $ ( 278,482 )

Unrealized loss on defined benefit pension plan ( 374 ) ( 368 ) —

Foreign currency translation (loss) gain ( 1,871 ) 507 1,515

Unrealized gain (loss) on marketable debt securities 3,696 ( 2,484 ) ( 1,175 )

Unrealized gain (loss) on defined benefit pension plan 328 ( 374 ) ( 368 )

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

Unrealized (loss) gain on marketable debt securities ( 374 ) 3,696 ( 2,484 )

Comprehensive loss $ ( 320,169 ) $ ( 109,948 ) $ ( 280,827 )

9 unchanged sentences

BALANCE - DECEMBER 31, 2021 62,491,498 $ 6 $ 1,068,634 $ ( 562 ) $ ( 765,966 ) $ 302,112

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

Share based compensation — — 37,897 — — 37,897

Issuance of common stock under the equity incentive plan and proceeds from exercise 935,598 — 4,585 — — 4,585

Employee stock purchase program stock purchase and expense 166,961 — 3,012 — — 3,012

Equity offering, net of issuance costs of $ 12.2 million

7,532,500 1 189,278 — — 189,279

Employee stock purchase program purchase and expense 161,874 — 4,259 — — 4,259

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

701,600 — 19,545 — — 19,545

Unrealized loss on defined benefit pension plan — — — ( 368 ) — ( 368 )

Foreign currency translation adjustments — — — 507 — 507

2 unchanged sentences

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

1 unchanged sentence

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 )

5 unchanged sentences

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 )

9 unchanged sentences

Net loss $ ( 321,545 ) $ ( 111,399 ) $ ( 278,482 )

Net income from discontinued operations 264,934 52,986 37,201

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

Net loss from continuing operations ( 320,630 ) ( 376,333 ) ( 331,468 )

2 unchanged sentences

Share based compensation 36,913 44,246 38,143

In-process research and development 65,205 — —

Loss on extinguishment of debt — — 7,578

1 unchanged sentence

Amortization of debt discount and issuance costs 1,725 1,718 1,622

Amortization of (discounts) premiums on investments ( 7,456 ) ( 700 ) 2,008

Amortization of discounts on investments ( 4,535 ) ( 7,456 ) ( 700 )

Other 7,944 ( 3,626 ) 1,346

10 unchanged sentences

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

Net cash provided by operating activities - discontinued operations 45,336 74,555 61,446

Net cash (used in) provided by operating activities - discontinued operations ( 7,451 ) 45,336 74,555

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

Cash Flows From Investing Activities:

Proceeds from the sale/maturity of marketable debt securities 334,575 381,993 433,604

Proceeds from the sale and maturity of marketable debt securities 326,334 334,575 381,993

Purchase of marketable debt securities ( 125,757 ) ( 443,942 ) ( 385,389 )

Purchase of fixed assets ( 668 ) ( 191 ) ( 5,101 )

Purchase of intangible assets ( 36,212 ) ( 41,591 ) ( 28,366 )

Payment of milestone ( 65,000 ) — —

Other ( 40 ) ( 668 ) ( 791 )

Net cash used in investing activities - continuing operations ( 151,626 ) ( 32,553 ) ( 137,623 )

Net cash provided by (used in) investing activities - continuing operations 99,325 ( 151,626 ) ( 32,553 )

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

8 unchanged sentences

Proceeds from exercise of stock options 4,452 3,240 4,585

Proceeds from the issuances under the employee stock purchase program 3,166 2,978 2,112

Proceeds from the issuances under the employee stock purchase plan 2,332 3,166 2,978

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

3 unchanged sentences

Effect of exchange rate changes on cash ( 913 ) 1,981 ( 2,794 )

Net (decrease) increase in cash and cash equivalents ( 3,512 ) ( 104,065 ) 80,981

Net increase (decrease) in cash and cash equivalents 359 ( 3,512 ) ( 104,065 )

Cash and cash equivalents, beginning of year 58,176 61,688 165,753

3 unchanged sentences

Cash paid for interest $ 8,838 $ 8,838 $ 10,159

Cash (paid) refunded for income taxes $ ( 578 ) $ ( 996 ) $ 16,420

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

Non-cash investing and financing activities:

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Travere is a fully integrated biopharmaceutical company headquartered in San Diego, California focused on identifying, developing and delivering life-changing therapies to people living with rare kidney and metabolic diseases.

The Company regularly evaluates and, where appropriate, acts on opportunities to expand its product pipeline through licenses and acquisitions of products in areas that will serve patients with serious unmet medical need and that the Company believes offer attractive growth characteristics.

The Company regularly evaluates and, where appropriate, acts on opportunities to expand its product pipeline and approved products through licenses and acquisitions of products in areas that will serve rare disease patients with serious unmet medical need and that the Company believes offer attractive growth characteristics.

Discontinued Operations - Sale of Bile Acid Product Portfolio

On July 16, 2023, Travere entered into an Asset Purchase Agreement (the “Purchase Agreement”) with Mirum Pharmaceuticals, Inc.

In July 2023, Travere entered into an Asset Purchase Agreement (the “Purchase Agreement”) with Mirum Pharmaceuticals, Inc.

("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".

7 unchanged sentences

FILSPARI® (sparsentan)

On February 17, 2023, the U.S.

Food and Drug Administration (the "FDA") granted accelerated approval of FILSPARI® (sparsentan) to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression, generally a UPCR ≥1.5 gram/gram.

FILSPARI, a once-daily, oral medication is designed to selectively target two critical pathways (endothelin 1 and angiotensin-II) in the disease progression of IgAN.

This indication was granted under accelerated approval based on reduction in proteinuria.

The continued approval of FILSPARI may be contingent upon confirmation of a clinical benefit in the Company's Phase 3 clinical trial of sparsentan for the treatment of IgAN (the "PROTECT Study").

In September 2023, the Company announced topline two-year confirmatory secondary endpoint results from the PROTECT Study and i n December 2023, the Company announced the completion of a successful pre-NDA meeting with the FDA for FILSPARI in IgAN.

Following its regulatory engagement, the Company plans to submit a supplemental New Drug Application (sNDA) for conversion of the existing U.S.

accelerated approval of FILSPARI to full approval.

In August 2022, the Company and Vifor (International) Ltd.

("CSL Vifor"), with whom the Company entered into a license and collaboration agreement ("License Agreement") in September 2021, announced that the European Medicines Agency (the "EMA") had accepted for review the MAA of sparsentan for the treatment of IgAN in the EU.

The Company is awaiting an opinion by the Committee for Medicinal Products for Human Use (the "CHMP").

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).

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.

("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.

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.

Thiola® and Thiola EC® (tiopronin tablets)

3 unchanged sentences

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.

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

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.

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.

Together with CSL Vifor, the Company also plans to engage with the EMA to determine the potential for a subsequent variation to the Conditional Marketing Authorization (CMA) of sparsentan for the treatment of FSGS, subject to a review decision on the pending application for CMA of sparsentan in IgAN.

The Company is conducting additional analyses of FSGS data and intends to engage with regulators to evaluate potential regulatory pathways for a sparsentan FSGS indication.

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.

Pegtibatinase

4 unchanged sentences

The HARMONY Study is a global, randomized, multi-center, double-blind, placebo-controlled Phase 3 clinical trial designed to evaluate the efficacy and safety of pegtibatinase as a novel treatment to reduce total homocysteine (tHcy) levels.

Topline results from the HARMONY Study are expected in 2026.

In the beginning of 2024, the first patients were dosed in the HARMONY Study.

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

Preclinical Programs:

The Company is a participant in a Cooperative Research and Development Agreement ("CRADA"), which forms a multi-stakeholder approach to pool resources with leading experts and incorporate the patient perspective early in the therapeutic identification and development process.

The Company is partnering with the National Institutes of Health’s National Center for Advancing Translational Sciences ("NCATS") and a leading patient advocacy organization, Alagille Syndrome Alliance, aimed at the identification of potential small molecule therapeutics for Alagille syndrome ("ALGS").

There are no treatment options currently approved for ALGS.

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.

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Payments received under collaboration and licensing agreements may include non-refundable fees at the inception of the arrangements, milestone payments for specific achievements and royalties on the sale of products.

At the inception of arrangements that include milestone payments, the Company uses judgement to evaluate whether the milestones are probable of being achieved and estimates the amount to include in the transaction price utilizing the most likely amount method.

At the inception of arrangements that include milestone payments, the Company uses judgment to evaluate whether the milestones are probable of being achieved and estimates the amount to include in the transaction price utilizing the most likely amount method.

If it is probable that a significant revenue reversal will not occur, the estimated amount is included in the transaction price.

1 unchanged sentence

At the end of each reporting period, the Company re-evaluates the probability of achievement of development milestones and any related constraint and adjusts the estimate of the overall transaction price, if necessary.

The Company recognizes aggregate sales-based milestones and royalty payments from product sales of which the license is deemed to be the predominant item to which the royalties relate, 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.

Revenue from collaboration and licensing agreements may also include sales of inventory, at cost plus a margin, which is recorded in license and collaboration revenue.

The Company utilizes significant judgement to develop estimates of the stand-alone selling price for each distinct performance obligation based upon the relative stand-alone selling price.

The Company utilizes significant judgment to develop estimates of the stand-alone selling price for each distinct performance obligation based upon the relative stand-alone selling price.

Variable consideration that relates specifically to the Company’s efforts to satisfy specific performance obligations is allocated entirely to those performance obligations.

The stand-alone selling price for license-related performance obligations requires judgement in developing assumptions to project probability-weighted cash flows based upon estimates of forecasted revenues, clinical and regulatory timelines and discount rates.

The stand-alone selling price for license-related performance obligations requires judgment in developing assumptions to project probability-weighted cash flows based upon estimates of forecasted revenues, clinical and regulatory timelines and discount rates.

The stand-alone selling price for clinical development performance obligations is based on forecasted expected costs of satisfying a performance obligation plus an appropriate margin.

11 unchanged sentences

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 $ 2.4 million and zero at December 31, 2023 and 2022, respectively.

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, 2024 and 2023 ( in thousands ):

5 unchanged sentences

Classified as:

Inventory, net $ 9,410 $ 4,523

Long-term inventory, net 31,494 —

Inventory $ 6,200 $ 9,410

Long-term inventory 35,656 31,494

Total inventory $ 41,856 $ 40,904

The balance classified as long-term inventory consists of raw materials and work in process for FILSPARI as of December 31, 2023.

The balance classified as long-term inventory consists of raw materials, work in process and finished goods for both Thiola and FILSPARI as of December 31, 2024.

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

1 unchanged sentence

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 currently consists of the sale of active pharmaceutical ingredients to the Company's collaboration partner, at cost plus a margin.

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.

The following table summarizes cost of goods sold for the years ended December 31, 2024, 2023 and 2022 ( in thousands ):

5 unchanged sentences

Capitalization of Inventory Costs

Prior to the regulatory approval of the Company's therapeutic candidates, the Company incurs expenses for the manufacture of drug product supplies to support clinical development that could potentially be available to support the commercial launch of those therapies.

Prior to the regulatory approval of the Company's drug candidates, the Company incurs expenses for the manufacture of drug product supplies to support clinical development that could potentially be available to support the commercial launch of those drugs.

The Company capitalizes inventory costs associated with its products after regulatory approval, when, based on management’s judgment, future commercialization is considered probable and the future economic benefit is expected to be realized.

1 unchanged sentence

Any eventual sale of previously expensed ("zero-cost") inventories may impact future margins, for any periods in which those inventories are sold.

Prior to the February 2023 FDA accelerated approval of FILSPARI (sparsentan), the Company recognized approximately $ 7.5 million in research and development expenses related to the production of active pharmaceutical ingredients to support the commercial launch of FILSPARI.

Prior to the February 2023 FDA accelerated approval of FILSPARI (sparsentan), the Company expensed the production of active pharmaceutical ingredients purchased to support the commercial launch of FILSPARI, in research and development expenses.

For the year ended December 31, 2024, sales of FILSPARI primarily consisted of zero-cost inventories.

As of December 31, 2023, the Company had $ 7.2 million of zero-cost inventory remaining.

The Company expects to continue to benefit from the sale of previously expensed inventories through at least 2025.

The Company began capitalizing inventory costs associated with FILSPARI (sparsentan) following the February 2023 approval for treatment in IgAN.

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.

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.

4 unchanged sentences

The Company's research and development costs are composed of salaries and bonuses, benefits, share-based compensation, license fees, milestones under license agreements, costs paid to third-party contractors to perform research, conduct clinical trials, costs to develop drug materials and delivery devices, costs to manufacture drug product supplies to support clinical development, and associated overhead expenses and facilities costs.

The Company charges direct internal and external program costs to the

respective development programs.

The Company charges direct internal and external program costs to the respective development programs.

The Company also incurs indirect costs that are not allocated to specific programs because such costs benefit multiple development programs and allow us to increase our pharmaceutical development capabilities.

13 unchanged sentences

Revisions to the Company's contractual payment obligations are charged to expense in the period in which the facts that give rise to the revision become reasonably certain.

The Company currently has one Phase 1/2 clinical trial and three Phase 3 clinical trials in process that are in varying stages of activity, with ongoing non-clinical support trials.

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.

5 unchanged sentences

For service based vesting grants, expense is recognized over the requisite service period.

For PSUs, expense is recognized over the implicit service period, assuming vesting is probable.

For PSUs, expense is recognized over the implicit service period, once vesting is probable.

No expense is recognized for PSUs if it is not probable the vesting criteria will be satisfied.

32 unchanged sentences

The allowance for credit losses was zero at both December 31, 2024 and 2023, respectively.

For the years ended December 31, 2023, 2022 and 2021, bad debt expense recorded in the Consolidated Statements of Operations and Comprehensive Loss was immaterial.

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

4 unchanged sentences

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.

Segment Information

The Company currently operates in one operating segment focused on the development and commercialization of innovative therapies for people with serious and life-threatening rare diseases and medical conditions.

The Company is not organized by market and is managed and operated as one business.

A single management team reports to the chief operating decision maker who comprehensively manages the entire business.

The Company does not operate any separate lines of business or separate business entities with respect to its products.

Accordingly, the Company does not accumulate discrete financial information with respect to separate products, other than revenues, and does not have separately reportable segments.

Property and Equipment, net

1 unchanged sentence

Depreciation is computed using the straight-line method over the related estimated useful lives as presented in the table below.

Significant additions and improvements are capitalized, while repairs and maintenance are

charged to expense as incurred.

Significant additions and improvements are capitalized, while repairs and maintenance are charged to expense as incurred.

Property and equipment purchased for specific research and development projects with no alternative use is expensed as incurred.

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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 and Comprehensive Loss 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.

Intangible Assets, Net

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Intangible Assets with Cost Accumulation Model

In 2014, the Company entered into a license agreement with Mission Pharmacal in which the Company obtained the exclusive right to license the trademark of Thiola.

In 2014, the Company entered into a license agreement with Mission Pharmacal ("Mission") in which the Company obtained the exclusive right to license the trademark of Thiola ("Mission License Agreement").

The acquisition of the Thiola license qualified as an asset acquisition under the principles of ASC 805, Business Combinations ("ASC 805") in effect at the time of acquisition.

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The liability for royalties in excess of the annual contractual minimum is recognized in the period in which the royalties become probable and estimable, which is typically in the period corresponding with the respective sales.

The Company records an offsetting increase to the cost basis of the asset under the cost accumulation model ("Thiola Intangible").

The additional cost basis is subsequently amortized over the remaining useful life.

The Company records an offsetting increase to the cost basis of the intangible asset under the cost accumulation model ("Thiola Intangible").

The additional cost basis is subsequently amortized over the remaining estimated useful life of the license agreement.

In the second quarter of 2023, the Company reduced the estimated useful life of the Thiola Intangible to better reflect the pattern of projected future cash flows, resulting in incremental expense of $ 3.7 million recorded in selling, general, and administrative .

The change in estimated useful life has been accounted for as a change in accounting estimate and the remaining carrying amounts of the Thiola Intangible will be amortized prospectively over the new useful life.

The change in estimated useful life was accounted for as a change in accounting estimate and the remaining carrying amounts of the Thiola Intangible are being amortized prospectively over the new useful life.

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, 2024 as such royalties are not yet probable and estimable.

In 2012, the Company entered into an agreement with Ligand Pharmaceuticals, Inc.

(“Ligand”) for a worldwide sublicense to develop, manufacture and commercialize sparsentan (the “Ligand License Agreement”).

The acquisition of the Ligand License Agreement qualified as an asset acquisition under the principles of ASC 805 in effect at the time of acquisition.

The license agreement requires the Company to make royalty payments based on net sales of FILSPARI (sparsentan) and milestone payments.

The liabilities for royalties and milestone payments are recognized in the period in which they become probable and estimable, which is typically in the period corresponding with the respective sales or achievement of the milestone.

The Company records an offsetting increase to the cost basis of the intangible asset under the cost accumulation model following the approval of FILSPARI.

The additional cost basis is subsequently amortized over the remaining estimated useful life.

Variable Interest Entity

The Company reviews each investment and collaboration agreement to determine if it has a variable interest in the entity.

In assessing whether the Company has a variable interest in the entity as a whole, the Company considers and makes judgements regarding the purpose and design of the entity, the value of the licensed assets to the entity, the value of the entity’s total assets and the significant activities of the entity.

In assessing whether the Company has a variable interest in the entity as a whole, the Company considers and makes judgments regarding the purpose and design of the entity, the value of the licensed assets to the entity, the value of the entity’s total assets and the significant activities of the entity.

If the Company has a variable interest in the entity as a whole, the Company assesses whether or not the Company is a primary beneficiary of that VIE, based on a number of factors, including:

(i) which party has the power to direct the activities that most significantly affect the VIE’s economic performance, (ii) the

parties’ contractual rights and responsibilities pursuant to the collaboration agreement, and (iii) which party has the obligation to absorb losses of or the right to receive benefits from the VIE that could be significant to the VIE.

(i) which party has the power to direct the activities that most significantly affect the VIE’s economic performance, (ii) the parties’ contractual rights and responsibilities pursuant to the collaboration agreement, and (iii) which party has the obligation to absorb losses of or the right to receive benefits from the VIE that could be significant to the VIE.

If the Company determines that it is the primary beneficiary of a VIE at the onset of the collaboration, the collaboration is treated as a business combination and the Company consolidates the financial statements of the VIE into the Company’s consolidated financial statements.

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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.

Equity Securities

The Company applies the equity method of accounting for investments when it has significant influence, but no controlling interest in the investee.

Judgment regarding the level of influence over each equity method investment includes key factors such as ownership interest, representation on the board of directors, participation in joint steering committees and material intercompany transactions.

Upon investment, the Company evaluates any basis difference between the carrying value and fair value of the Company's proportionate share of the investee's net assets.

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.

See Note 5 for further discussion.

Investments accounted for using the equity method are be reported on a lag of up to three months if the financial statements of the investee are not available in sufficient time for the Company to apply the equity method as of the current reporting date.

Goodwill represents the excess of purchase price over fair value of net assets acquired in a business combination and is not amortized.

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The Company has one segment and one reporting unit and as such reviews goodwill for impairment at the consolidated level.

For the years ended December 31, 2023, 2022 and 2021 there were no impairments to goodwill.

Impairment of Long-Lived Assets

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the amount and timing of projected future cash flows (including revenue, cost of sales, research and development costs, and sales and marketing expenses), and the discount rate selected to measure the risks inherent in the future cash flows.

There were no impairments related to finite-lived intangible assets in the years ended December 31, 2023, 2022 and 2021.

See Note 8 for further discussion of certain long-lived assets measured at fair value on a nonrecurring basis when there are indicators of impairment.

The Company follows ASC 740, Income Taxes ("ASC 740"), which requires recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns.

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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.

The aggregate gain arising from foreign exchange transactions included in other income (expense), net for the years ended December 31, 2023, 2022 and 2021 was $ 0.5 million, $ 1.4 million, and $ 0.3 million, respectively.

The results and financial position of the Company that have a functional currency different from the US dollar are translated as follows:

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.

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

dollar are translated as follows:

assets and liabilities presented are translated at the closing exchange rate as of December 31, 2024 and 2023;

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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, 2024, 2023 and 2022 ( in thousands ):

Foreign Currency Translation Adjustments included in Accumulated Other Comprehensive Loss

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

2024 2023 2022

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Reclassifications

Certain reclassifications have been made to the prior year financial statements in order to conform to the current year’s presentation, including reclassifying the prior period carrying values of the assets and liabilities included in the sale of the bile acid business as assets and liabilities of discontinued operations within the Consolidated Balance Sheets, and revenues and expenses attributable to the bile acid business as net income from discontinued operations.

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

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

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

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.

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One-time termination benefits are expensed at the date the entity notifies the employee, unless the employee must provide future service, in which case the benefits are expensed ratably over the service period.

Termination benefits are calculated based on a regional benefit practices and local statutory requirements.

Termination benefits are calculated based on regional benefit practices and local statutory requirements.

In December 2023, the Company initiated a restructuring plan that resulted in a reduction of its workforce, primarily impacting non-field-based employees.

One-time termination benefits include severance, continuation of health insurance coverage, and other benefits for a specified period of time.

The Company estimates that it will incur a total of $ 12.0 million to $ 14.0 million in non-recurring charges in connection with the restructuring, of which the Company has recognized $ 11.4 million for the year ended December 31, 2023.

As of December 31, 2023, the Company recorded accrued restructuring costs of $ 11.4 million, which is included in accrued expenses of the Consolidated Balance Sheets.

No cash payments were made related to the restructuring during 2023.

The Company expects that it will incur the remaining estimated restructuring costs during 2024.

The Company intends to pay all restructuring plan amounts during 2024.

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 ):

Liability balance at January 1, $ 11,421 $ —

Restructuring expenses 2,438 11,394

Non-cash impairment and disposal charges ( 856 ) —

Payments ( 12,929 ) —

Foreign currency impact ( 74 ) 27

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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.

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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 November 2024, the FASB issued ASU No.

2024-04, Debt with Conversion and Other Options (Subtopic 470-20):

Induced Conversions of Convertible Debts Instruments.

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

In November 2024, the FASB issued ASU No.

2024-03, Income Statement - Reporting Comprehensive Income - Expense Recognition Disclosures.

This ASU will require entities to provide enhanced disclosures related to certain expense categories included in income statement captions.

The ASU aims to increase transparency and provide investors with more detailed information about the nature of expenses reported on the face of the income statement.

The new standard does not change the requirements for the presentation of expenses on the face of the income statement.

Under this ASU, entities are required to disaggregate, in a tabular format, expense captions presented on the face of the income statement — excluding earnings or losses from equity method investments — if they include any of the following expense categories:

purchases of inventory, employee compensation, depreciation, intangible asset amortization, and depreciation or depletion.

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

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.

Early adoption is permitted.

The Company expects to adopt this new standard beginning in fiscal 2025 when it becomes effective.

In November 2023, the FASB issued ASU No.

2023-07, Improvements to Reportable Segment Disclosure.

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.

Early adoption is permitted.

The Company will adopt this new guidance beginning in fiscal 2024 when it becomes effective.

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

REVENUE RECOGNITION

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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 99 % of net product sales.

The Company sells FILSPARI to three direct-to-patient specialty pharmacies.

The Company sells its other products to patients and pharmacies, with distribution facilitated through a single direct-to-patient distributor.

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

The Company sells its tiopronin products to patients and pharmacies, with distribution facilitated through a single direct-to-patient distributor.

Revenues from product sales are recognized in satisfaction of a single performance obligation when the customer obtains control of the Company’s product.

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The Company receives payments from its FILSPARI sales based on terms that are generally 30 days from shipment of the product to the specialty pharmacy.

For the Company's other products, product sales are recognized upon delivery to the patient.

The Company receives payments from sales of its other products, primarily through third party payers, based on terms that generally are within 30 days of delivery of product to the patient .

For the Company's tiopronin products, product sales are recognized upon delivery to the patient.

The Company receives payments from sales of its tiopronin products, primarily through third party payers, based on terms that generally are within 30 days of delivery of product to the patient .

Contracts do not contain significant financing components based on the typical period of time between performance of services and collection of consideration.

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If actual results in the future vary from the Company’s provisions, the Company will adjust the estimate, which would affect net product revenue and earnings in the period such variances become known.

For the years ended December 31, 2023, 2022 and 2021, the Company recorded a net product revenue increase of $ 0.4 million, $ 0.2 million, and $ 0.2 million, respectively, related to performance obligations satisfied in previous periods.

For the years ended December 31, 2024, 2023 and 2022, adjustments to net product revenue related to performance obligations satisfied in previous periods were $ 0.5 million, $ 0.4 million, and $ 0.2 million, respectively.

Government Rebates:

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The Company accrues for the calculated prompt pay discount based on the gross amount of each invoice for those customers at the time of sale.

The Company pays service fees to certain customers based on a contractually fixed percentage of the wholesale acquisition cost and fees for data.

Other fees are recorded as an offset to revenue based on contractual terms at the time revenue from the sale is recognized.

Product Returns:

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2024 2023 2022

Tiopronin products $ 98,329 $ 97,970 $ 115,122

FILSPARI $ 132,222 $ 29,208 $ —

Tiopronin products 94,485 98,329 97,970

Total net product sales $ 226,707 $ 127,537 $ 97,970

COLLABORATION AND LICENSE AGREEMENTS

License Agreement with CSL Vifor

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

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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 will be responsible for all commercialization activities 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.

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

Sales-based milestone payments and royalties on net sales were excluded from the 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 have been satisfied.

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.

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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 will be recognized over the development period based upon the ratio of costs incurred to date to the total estimated costs.

The Company recognized a total of $ 17.7 million in license and collaboration revenue for the year ended December 31, 2023, 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.

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.

For the year ended December 31, 2022, the Company recognized a total of $ 11.5 million in license and collaboration revenue for clinical development activities, based upon the ratio of costs incurred to total estimated costs.

Deferred revenue related to the clinical development activities as of December 31, 2023 was $ 8.9 million.

Of this amount, $ 7.1 million was classified as current as of December 31, 2023, based upon amount expected to be realized within the next year.

As of December 31, 2022, deferred revenue related to the clinical development activities was $ 22.9 million, of which $ 12.0 million was classified as current.

The Company estimates that the remainder of the deferred revenue balance will be fully realized by mid-2025.

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 following table sets forth a summary of changes in deferred revenue for the years ended December 31, 2024, 2023 and 2022 (in thousands) :

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Balance at January 1, $ 8,931 $ 22,907 $ 36,647

New consideration resulting in deferred revenue — — 55,000

License and collaboration revenue ( 5,847 ) ( 14,363 ) ( 11,490 )

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Balance at December 31, $ 2,815 $ 8,931 $ 22,907

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.

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.

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.

VARIABLE INTEREST ENTITIES

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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.

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.

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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.

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.

MARKETABLE DEBT SECURITIES

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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

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Total available-for-sale marketable debt securities $ 507,934 $ 1,640 $ ( 899 ) $ 508,675

During 2023 and 2022, realized gains on marketable debt securities were immaterial.

During 2024 and 2023, realized gains and losses on marketable debt securities were immaterial.

As of December 31, 2024 and December 31, 2023, the accrued interest receivable related to the Company's marketable debt securities was $ 2.3 million and $ 4.6 million, respectively, and was recorded in prepaid expenses and other current assets on the Consolidated Balance Sheets.

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Any amount deemed to be attributable to credit loss is recognized in the income statement, with the amount of the loss limited to the difference between fair value and amortized cost and recorded as an allowance for credit losses.

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

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 ):

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Total convertible senior notes, net of unamortized debt discount and debt issuance costs $ 378,988 $ 377,263

Classified as:

Convertible debt, current portion $ 68,678 $ —

Convertible debt, less current portion 310,310 377,263

Total convertible debt $ 378,988 $ 377,263

Convertible Senior Notes Due 2029

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(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;

(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;

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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, 2023 as long-tern convertible debt.

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.

Interest Expense

3 unchanged sentences

Contractual interest expense $ 8,838 $ 8,838 $ 8,433

Amortization of debt discount — — 10,339

Amortization of debt issuance costs 1,725 1,718 1,622

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Total $ 566,851 $ 58,176 $ 508,675 $ —

Assets Measured at Fair Value on a Nonrecurring Basis

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, 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.

The fair value of the asset group was determined under the income approach based on projected future cash flows from the operating sublease discounted by a risk adjusted rate of 6.9 %.

The Company classified the fair value of the asset group as Level 3.

See Note 18 for further discussion.

INTANGIBLE ASSETS

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Ligand License Agreement

In 2012, the Company entered into an agreement with Ligand Pharmaceuticals, Inc.

("Ligand") for a worldwide sublicense to develop, manufacture and commercialize sparsentan (the “Ligand License Agreement”).

In 2012, the Company entered into the Ligand License Agreement with Ligand for a worldwide sublicense to develop, manufacture and commercialize sparsentan.

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.

In March 2023, the Company capitalized a $ 23.0 million milestone payment to Ligand (and Bristol-Myers Squibb Company ("BMS")) that was triggered upon the accelerated approval of FILSPARI in February 2023.

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

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.

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.

The Company began incurring costs associated with such royalties following the February 2023 approval of FILSPARI (sparsentan).

For the year ended December 31, 2023, the Company capitalized $ 4.4 million to intangible assets for royalties owed on net sales of FILSPARI.

The cost of the $ 23.0 million milestone payment and royalty payments are being amortized to selling, general and administration on a straight-line basis through April 30, 2033

Thiola License Agreement

The Company entered into a license agreement with Mission Pharmacal in 2014, 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 is 10 years and will automatically renew thereafter for periods of one year .

The acquisition of the Thiola license qualified as an asset acquisition under the principles of ASC 805 in effect at the time of acquisition.

The license agreement requires the Company to make royalty payments based on net sales of Thiola.

The Company records an offsetting increase to the cost basis of the asset under the cost accumulation model.

The additional cost basis is subsequently amortized over the remaining life of the license agreement.

For the years ended December 31, 2024 and 2023, the Company capitalized $ 20.3 million and $ 4.4 million, respectively, to intangible assets for royalties owed on net sales of FILSPARI.

The cost of the milestone payments and royalty payments are being amortized to selling, general and administration on a straight-line basis through April 30, 2033

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.

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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 $ 8.2 million and $ 9.7 million as of December 31, 2024 and 2023, respectively.

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, 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.

The Company has capitalized $ 155.6 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 payments through December 31, 2023 in excess of minimum royalties.

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.

The Company has capitalized $ 171.0 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, 2024 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.

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Useful Life Gross Carrying Amount Accumulated Amortization Net Book Value

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

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

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

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Useful Life Gross Carrying Amount Accumulated Amortization Net Book Value

Thiola license 12 $ 139,383 $ ( 50,324 ) $ 89,059

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

Ligand license 11 27,448 ( 2,036 ) 25,412

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Total $ 103,221

There were no impairments related to finite-lived intangible assets in the years ended December 31, 2024, 2023 and 2022.

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

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Research and development 16,090 26,006

Accrued royalties 12,309 6,991

Sales discounts, rebates, and allowances 10,585 13,730

Selling, general and administrative 6,154 7,190

Transition services accrual 285 12,282

Accrued restructuring costs — 11,421

Selling, general and administrative 7,190 8,791

Accrued royalties 6,991 7,755

Miscellaneous accrued 11,463 4,373

Miscellaneous accrued expenses 5,439 11,463

Total accrued expenses $ 86,028 $ 118,991

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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 US 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.

In accordance with ASC 450, contingent cash payments will be accrued for when it is probable that a liability has been incurred and the amount can be reasonably estimated.

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.

In accordance with ASC 450, Contingencies , contingent cash payments will be accrued for when it is probable that a liability has been incurred and the amount can be reasonably estimated.

In March 2024, the Company recognized $ 65.2 million in IPR&D expense upon the achievement of a development milestone, which was paid during the second quarter of 2024 and recorded within investing activities in the Consolidated Statements of Cash Flows.

As of December 31, 2024, no contingent cash payments have been accrued.

The Company anticipates that it may achieve certain milestones with both FILSPARI and pegtibatinase that will result in the Company making net payments of approximately $ 50.0 million in the next 12 months.

Legal Proceedings

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As discussed in Note 15, as part of its February 2023 underwritten public offering, the Company issued and sold pre-funded warrants to purchase 1.25 million shares of its common stock at a price to the public of $ 20.9999 per pre-funded warrant.

The pre-funded warrants are exercisable immediately and are exercisable for one share of the Company's common stock.

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

Since the $ 0.0001 price per share represents little consideration and is non-substantive in relation to the $ 20.9999 price per pre-funded warrant and the $ 21.00 price per share of the common stock offered to the public, and as the warrants are immediately exercisable with no further vesting conditions or contingencies associated with them, the shares underlying the warrants are therefore included in the calculation of basic net loss per common share.

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

Due to the nominal exercise price of the pre-funded warrants and the lack of any contingencies to exercise, the shares underlying the pre-funded warrants have been included in the calculation of basic net loss per common share since the date the warrants were issued.

The Company’s potentially dilutive shares, which include outstanding stock options, restricted stock units, performance-based stock units, and shares issuable upon conversion of the 2025 Notes and 2029 Notes, are considered to be common stock equivalents and are not included in the calculation of diluted net loss per share because their effect is anti-dilutive.

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Foreign — — ( 1 )

Total current 120 223 313

Federal — — —

Total deferred — — —

Total tax provision $ 120 $ 223 $ 313

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Foreign rate differential 2.15 % 1.29 % 0.81 %

IPR&D 4.27 % — % — %

Nondeductible executive compensation 0.44 % 1.50 % 0.41 %

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Change in valuation allowance 16.69 % 16.78 % 32.49 %

Income tax provision (benefit) 0.06 % 0.09 % 0.19 %

Income tax provision 0.04 % 0.06 % 0.09 %

The significant components of the Company’s deferred tax assets and liabilities as of December 31, 2024 and 2023 are as follows ( in thousands ):

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Research and development and other tax credits 91,760 77,555

Intangible assets 53,919 47,731

Capitalized research and development 47,880 39,907

Contingent consideration — 18,124

Other accrued expenses 13,187 13,247

Stock based compensation 15,680 21,607

Other accrued expenses 14,266 13,187

Charitable contributions 5,797 6,110

Intangible assets greater than book 47,731 51,391

Interest expense limitation 1,679 4,346

Operating lease liabilities 5,421 6,812

Tax basis depreciation greater than book depreciation 292 105

Difference in basis of loan costs 62 15

296,473 300,268

Depreciation 435 292

Loan costs 153 62

Interest expense limitation — 1,679

Total deferred tax assets 348,614 296,473

Deferred Tax Liabilities:

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Prepaid assets ( 178 ) ( 198 )

( 5,793 ) ( 6,864 )

Total deferred tax liabilities ( 4,437 ) ( 5,793 )

Net deferred tax assets before valuation allowance 344,177 290,680

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The Company has recorded a valuation allowance of $ 344.2 million as of December 31, 2024 to reflect the estimated amount of deferred tax assets that may not be realized.

The Company decreased its valuation allowance by $ 2.7 million for the year ended December 31, 2023, compared to a $ 95.1 million increase for the year ended December 31, 2022.

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.

As of December 31, 2024, the Company had available unused U.S.

federal and state net operating loss (“NOL”) carryforwards of $ 223.8 million and $ 241.8 million, respectively, all of which are fully offset by a valuation allowance.

Additionally, the Company had an interest expense limitation carryforward of $ 8.0 million that is fully offset by a valuation allowance.

The federal NOL and interest expense limitation carryforward have an indefinite life.

The federal NOL has an indefinite life.

The state NOL carryforwards will begin to expire in 2025 unless previously utilized, except for $ 45.4 million of the state net operating losses that have an indefinite carryforward period.

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Pursuant to Internal Revenue Code Sections 382 and 383, use of the Company’s federal net operating loss and credit carryforwards may be limited upon a cumulative change in ownership of more than 50% within a three-year period.

The Company completed a study to analyze whether any ownership changes had occurred through March 31, 2023, and determined no ownership changes occurred.

The Company is in the process of updating its analysis of owner shifts to determine whether an ownership change occurred since March 31, 2023.

Any change in ownership should not impact the utilization of tax attributes for the year ended December 31, 2023, and due to the Company’s full valuation allowance any subsequent ownership changes will not impact the Company’s effective tax rate.

The Company continues to monitor potential historical ownership changes.

As of December 31, 2024, the Company had Irish NOL carryforwards of $ 14.2 million which are fully offset by a valuation allowance and have an indefinite life.

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

As of December 31, 2023, the Company had $ 22.9 million in unrecognized tax benefits, all of which are related to orphan drug and research and development tax credits and were recorded as a reduction to the deferred tax assets with a corresponding reduction in the Company’s valuation allowance of $ 22.9 million.

As of December 31, 2024, the Company had $ 27.4 million in unrecognized tax benefits, which were recorded as a reduction to the deferred tax assets with a corresponding reduction in the Company’s valuation allowance of $ 27.4 million.

To the extent unrecognized tax benefits are recognized at a time when a valuation allowance does not exist, the recognition of the $ 27.4 million tax benefit would reduce the effective tax rate.

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A reconciliation of the Company's unrecognized tax benefits for the years 2024, 2023 and 2022 is provided in the following table ( in thousands ):

2024 2023 2022

Balance as of January 1:

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federal jurisdiction, various state and local, and foreign jurisdictions.

With few exceptions related to the carryforward of unutilized tax attributes, the Company’s income tax returns are open to examination by federal authorities for the years ended December 31, 2019, and forward, and for state authorities, for the years ended December 31, 2014, and forward.

With few exceptions, the Company’s income tax returns are open to examination by federal and state authorities for the years ended December 31, 2013 and forward, due to the carryforward of unutilized tax attributes.

The Company's Swiss income tax returns are open to examination for the years ended December 31, 2019 and forward, and the Company's Irish tax returns are open to examination for the years ended December 31, 2020 and forward.

The Company recognizes interest and penalties as a component of income tax expense.

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

Interest and penalties for the years ended December 31, 2022 and 2021 were less than $ 0.1 million.

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

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

EQUITY OFFERINGS

Underwritten Public Offering of Common Stock

In November 2024, the Company sold an aggregate of approximately 9.0 million shares of its common stock in an underwritten public offering, at a price to the public of $ 16.00 per share of common stock.

The net proceeds to the Company from the offering, after deducting the underwriting discounts and offering expenses, were approximately $ 134.7 million.

In February 2023, the Company sold an aggregate of approximately 9.7 million shares of its common stock and pre-funded warrants to purchase 1.25 million shares of its common stock in an underwritten public offering, at a price to the public of $ 21.00 per share of common stock and $ 20.9999 per pre-funded warrant.

The pre-funded warrants are exercisable immediately, subject to certain beneficial ownership limitations which can be modified by the respective holders with at least 61 days' notice, and are exercisable for one share of the Company's common stock.

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 pre-funded warrants were classified as a component of permanent stockholders' equity within additional paid-in capital and were recorded at the issuance date using a relative fair value allocation method.

The pre-funded warrants are equity classified because they (i) are freestanding financial instruments that are legally detachable and separately exercisable from the equity instruments, (ii) are immediately exercisable, (iii) do not embody an obligation for the Company to repurchase its shares, (iv) permit the holders to receive a fixed number of shares of common stock upon exercise, (v) are indexed to the Company's common stock and (vi) meet the equity classification criteria.

In addition, such pre-funded warrants do not provide any guarantee of value or return.

The Company valued the pre-funded warrants at issuance, concluding that their sale price approximated their fair value, and allocated the aggregate net proceeds from the sale proportionately to the common stock and prefunded warrants, including approximately $ 24.6 million allocated to the pre-funded warrants and recorded as a component of additional paid-in capital.

In February 2021, the Company sold an aggregate of 7.5 million shares of its common stock in an underwritten public offering, at a price of $ 26.75 per share.

The net proceeds to the Company from the offering, after deducting the underwriting discounts and offering expenses, were $ 189.3 million.

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 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.

At-the-Market Equity Offering

In February 2020, the Company entered into an Open Market Sale Agreement ("ATM Agreement") with Jefferies LLC, as agent (“Jefferies”), pursuant to which the Company may offer and sell, from time to time through Jefferies, shares of its common stock having an aggregate offering price of up to $ 100.0 million.

Of the $ 100.0 million originally authorized for sale under the ATM Agreement, approximately $ 28.6 million were sold under the Company's prior registration statement on Form S-3 (Registration Statement No.

An additional $ 51.9 million were sold under the Company's effective registration statement on Form S-3 (Registration Statement No.

333-259311), which included $ 20.1 million in the year ended December 31, 2022.

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, 2023, an aggregate amount of $ 19.5 million remained eligible for sale under the ATM Agreement.

RETIREMENT PLAN

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Property, plant and equipment, net consisted of the following (in thousands ):

Computers and equipment $ 2,071 $ 2,049

Furniture and fixtures 2,990 2,938

Leasehold improvements $ 9,370 $ 9,692

Furniture and fixtures 2,446 2,990

Computers and equipment 2,275 2,071

Construction-in-progress — 169

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Total property and equipment, net $ 5,336 $ 7,479

The construction-in-process balance consists of costs related to the Company’s leasehold improvements at its facilities in San Diego, California.

Depreciation expense for the years ended December 31, 2024, 2023 and 2022 was $ 1.8 million, $ 2.2 million and $ 2.1 million, respectively.

As of December 31, 2023, the Company had two operating leases, including one operating lease with Kilroy Realty, L.P.

As of December 31, 2024, the Company had operating leases, including one 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.

Coinciding with the Company's ability to direct the use of the office space and utilizing a discount rate equal to the Company's estimated incremental borrowing rate, the Company established ROU assets totaling $ 34.6 million and lease liabilities totaling $ 34.5 million.

The total ROU asset and lease liability at measurement were each offset by lease incentives associated with tenant improvement allowances totaling $ 7.9 million.

Coinciding with the Company's ability to direct the use of the office space and utilizing a discount rate equal to the Company's estimated incremental borrowing rate, the Company established right-of-use assets totaling $ 34.6 million and lease liabilities totaling $ 34.5 million.

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.

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 ROU asset and lease liability measurements.

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.

The Company also has one operating lease with Esprit Investments Limited for office space located in Dublin, Ireland, which was entered into in October 2022.

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 an ROU asset and corresponding lease liability of $ 0.4 million.

The following is a schedule of the future minimum rental commitments for our operating leases reconciled to the lease liability and ROU asset as of December 31, 2023 ( in thousands ):

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.

The term of the sublease runs from January 2025 through August 2028.

The Company’s sublease arrangement has been classified as an operating lease with sublease income recognized on a straight-line basis over the term of the sublease arrangement.

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.

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.

There were no impairments related to right-of-use assets or property and equipment in the years ended December 31, 2023 and 2022.

The following is a schedule of the future minimum rental commitments for the Company's operating leases reconciled to the lease liability and ROU asset as of December 31, 2024 ( in thousands ):

December 31, 2024

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Weighted-average discount rate 6.48 % 6.48 %

For the year ended December 31, 2023, 2022 and 2021 the Company recorded $ 4.9 million, $ 5.0 million, and $ 4.9 million, respectively, in expense related to operating leases, including amortized tenant improvement allowances.

For the years ended December 31, 2024, 2023 and 2022 the Company recorded $ 4.8 million, $ 4.9 million, and $ 5.0 million, respectively, in expense related to operating leases, including amortized tenant improvement allowances.

Discontinued Operations

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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.

The Company's sale of the bile acid business resulted in a gain, net of tax, of $ 226.0 million.

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.

The net gain consists of net consideration, including the upfront payment and the deduction of investment banker fees owed upon the Closing, plus the derecognition of the carrying value of the net liabilities included in the transaction and the immaterial tax due on the sale.

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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 year ended December 31, 2023, the Company recognized $ 1.0 million, included in continuing operations within other income (expense), net, of which the Company collected $ 0.6 million as of December 31, 2023.

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 not anticipated to last beyond 12 months post-close.

TSA services provided by the Company are 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.

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Total other income (expense), net — 225,814 ( 261 )

Income from discontinued operations before income tax 264,934 52,986 37,201

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

Income tax on discontinued operations — — —

Net income from discontinued operations $ 264,934 $ 52,986 $ 37,201

Assets and liabilities of discontinued operations presented in the Consolidated Balance Sheets as of December 31, 2022 include the following ( in thousands ):

December 31, 2022

Current assets:

Inventory $ 2,399

Prepaid expenses and other current assets 591

Total current assets of discontinued operations 2,990

Intangible assets, net 47,965

Other assets 377

Total assets of discontinued operations $ 51,332

Current liabilities:

Business combination-related contingent consideration, current portion $ 7,000

Total current liabilities of discontinued operations 7,000

Business combination-related contingent consideration, less current portion 64,200

Total liabilities of discontinued operations $ 71,200

QUARTERLY FINANCIAL INFORMATION (UNAUDITED)

The following table presents selected consolidated statements of operations data for each quarter for the fiscal years ended December 31, 2023 and 2022 (unaudited, in thousands, except for per share data) :

First Second Third Fourth

For the year ended December 31, 2023:

Total revenue $ 30,888 $ 32,196 $ 37,095 $ 45,059

Total operating expenses 128,257 136,147 129,680 139,292

Operating loss ( 97,369 ) ( 103,951 ) ( 92,585 ) ( 94,233 )

Loss from continuing operations before income tax provision ( 96,486 ) ( 101,867 ) ( 89,229 ) ( 88,528 )

Loss from continuing operations, net of tax ( 96,564 ) ( 101,932 ) ( 89,241 ) ( 88,596 )

Income (loss) from discontinued operations, net of tax 1 10,233 16,302 239,976 ( 1,577 )

Net (loss) income ( 86,331 ) ( 85,630 ) 150,735 ( 90,173 )

(Loss) income per common share - basic and diluted:

Continuing operations $ ( 1.42 ) $ ( 1.34 ) $ ( 1.17 ) $ ( 1.16 )

Discontinued operations 0.15 0.21 3.14 ( 0.02 )

Net (loss) income per common share $ ( 1.27 ) $ ( 1.13 ) $ 1.97 $ ( 1.18 )

For the year ended December 31, 2022:

Total revenue $ 23,412 $ 28,634 $ 28,075 $ 29,339

Total operating expenses 95,393 107,160 110,679 116,041

Operating loss ( 71,981 ) ( 78,526 ) ( 82,604 ) ( 86,702 )

Loss from continuing operations before income tax provision ( 81,694 ) ( 79,970 ) ( 83,918 ) ( 85,573 )

Loss from continuing operations, net of tax ( 81,746 ) ( 80,023 ) ( 84,063 ) ( 85,636 )

Income from discontinued operations, net of tax 1 5,775 12,991 14,407 19,813

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

SEGMENT INFORMATION

The Company operates in one business segment focused on identifying, developing and delivering life-changing therapies to people living with rare kidney and metabolic diseases.

The determination of a single business segment is consistent with the consolidated financial information regularly provided to the Company’s chief operating decision maker (“CODM”), who is the President and Chief Executive Officer.

The CODM uses net loss to monitor budget versus actual results in assessing segment performance and the allocation of resources.

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.

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.

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, 2024, 2023 and 2022 ( in thousands ):

Year Ended December 31,

2024 2023 2022

Revenue $ 233,175 $ 145,238 $ 109,460

Cost of goods sold 7,744 11,450 4,420

Research and development:

External research and development 126,303 142,482 129,698

Internal personnel costs 73,843 84,658 75,664

Other Research and development 17,350 17,850 21,971

Total research and development 217,496 244,990 227,333

Selling, general and administrative 264,119 265,542 197,520

In-process research and development 65,205 — —

Restructuring 2,438 11,394 —

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

Income tax provision on continuing operations ( 120 ) ( 223 ) ( 313 )

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

Net loss $ ( 321,545 ) $ ( 111,399 ) $ ( 278,482 )

(Loss) income per common share - basic and diluted:

Continuing operations $ ( 1.29 ) $ ( 1.25 ) $ ( 1.31 ) $ ( 1.33 )

Discontinued operations 0.09 0.20 0.22 0.30

Net loss per common share $ ( 1.20 ) $ ( 1.05 ) $ ( 1.09 ) $ ( 1.03 )

1 On August 31, 2023, the Company sold its bile acid business, resulting in a gain, net of tax, of $ 226.0 million.

The Company has reflected the bile acid business as a discontinued operation in the Consolidated Financial Statements for all periods presented.

See Note 19 for results of discontinued operations and further discussion.

SUBSEQUENT EVENTS

On January 25, 2024, the Company announced that it has entered into an exclusive licensing agreement with Renalys Pharma, Inc.

("Renalys"), to bring sparsentan, a dual endothelin angiotensin receptor antagonist for the treatment of IgAN, to patients in Japan and other countries in Asia.

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

Under the terms of the agreement, Travere will receive an upfront payment and be eligible to receive up to $ 120 million in regulatory, development and sales-based milestone payments.

As part of the collaboration, Travere has obtained a minority equity stake in Renalys and will be eligible to receive tiered royalties on net sales of sparsentan in the licensed territories.

Renalys will be responsible for development, regulatory matters, and commercialization in the licensed territories.

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