ARDELYX, INC. 10-K

ITEM 9A. CONTROLS AND PROCEDURES Conclusions Regarding the Effectiveness of Disclosure Controls and Procedures As of December 31, 2024, management, with the participation of our CEO and Chief Financial and Operations Officer (CFOO), performed an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act. Our disclosure controls and procedures are designed to ensure that information required to be disclosed in the reports we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms, and that such information is accumulated and communicated to our management, including the CEO and the CFOO, to allow timely decisions regarding required disclosures. Any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objective and management necessarily applies its judgment in evaluating the cost-benefit 93 Table of Conten t s relationship of possible controls and procedures. Based on this evaluation, our CEO and CFOO concluded that, as of December 31, 2024, the design and operation of our disclosure controls and procedures were effective at a reasonable assurance level. Management’s Annual Report on Internal Control Over Financial Reporting Our management is responsible for establishing and maintaining adequate internal control over financial reporting. Internal control over financial reporting is a process designed by, or under the supervision of, our CEO and CFOO, and effected by our board of directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles and includes those policies and procedures that: • Pertain to the maintenance of records that accurately and fairly reflect in reasonable detail the transactions and dispositions of the assets of our company; • Provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that our receipts and expenditures are being made only in accordance with authorizations of our management and directors; and • Provide reasonable assurances regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material adverse effect on our financial statements. Our management assessed our internal control over financial reporting as of December 31, 2024, the end of the period covered by this Annual Report on Form 10-K. Management based its assessment on criteria established in “Internal Control—Integrated Framework (2013)” issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on management’s assessment of our internal control over financial reporting, management concluded that, as of December 31, 2024, our internal control over financial reporting was effective. Changes in Internal Control over Financial Reporting There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended December 31, 2024 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. Attestation Report of Independent Registered Public Accounting Firm Our independent registered public accounting firm, Ernst & Young LLP, has audited our Financial Statements included in Item 8 of this Annual Report on Form 10-K and have issued a report on our internal control over financial reporting as of December 31, 2024. Their report on the audit of internal control over financial reporting appears below. Report of Independent Registered Public Accounting Firm To the Stockholders and the Board of Directors of Ardelyx, Inc. Opinion on Internal Control Over Financial Reporting We have audited Ardelyx, Inc.’s internal control over financial reporting as of December 31, 2024, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) (the COSO criteria). In our opinion, Ardelyx, Inc. (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 balance sheets of Ardelyx, Inc. as of December 31, 2024 and 2023, the related statements of operations and comprehensive loss, stockholders’ equity, and cash flows for each of the three 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 The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting included in the accompanying Management’s Annual Report on Internal Control Over Financial Reporting. Our responsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit. We are a public accounting firm registered with the PCAOB and are 94 Table of Conten t s required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB. We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects. Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion. Definition and Limitations of Internal Control Over Financial Reporting A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. /s/ Ernst & Young LLP Boston, Massachusetts February 20, 2025 ITEM 9B. OTHER INFORMATION Trading Plans During the three months ended December 31, 2024, our Section 16 officers and directors adopted or terminated contracts, instructions or written plans for the purchase or sale of our securities as noted below: Name and Title of Director or Officer Action Date Trading Arrangement Total Shares Available to be Sold Expiration Date Rule 10b5-1* Non-Rule 10b5-1** Robert Blanks , Chief Regulatory Officer Termination December 20, 2024 X 339,500 June 21, 2024 * Intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) ** Not intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS Not Applicable. 95 Table of Conten t s PART III Items 10, 11, 12, 13, 14. As described below, we incorporate by reference in this Annual Report on Form 10-K certain information appearing in the Proxy Statement that we will furnish to our stockholders for our 2025 Annual Meeting of Stockholders. Incorporated by reference to our Proxy Statement Item 10. Directors, Executive Officers, and Corporate Governance. “Executive Officers,” “Election of Directors,” “Corporate Governance,” and “ Section 16(a) Beneficial Ownership Reporting Compliance” sections. We have included information regarding our Code Business Conduct and Ethics and our Insider Trading Policy below. Item 11. Executive Compensation. “Executive Compensation” section. Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters. “Security Ownership of Certain Beneficial Owners and Management” and “Equity Compensation Plan Information” sections. Item 13. Certain Relationships and Related Transactions, and Director Independence. “Certain Relationships and Related Party Transactions” and “Election of Directors” sections. Item 14. Principal Accountant Fees and Services. “Principal Accountant Fees and Services” section. Code of Business Conduct and Ethics We have adopted a Code of Business Conduct and Ethics that applies to our officers, directors and employees which is available on our website at www.ardelyx.com. The Code of Business Conduct and Ethics is intended to qualify as a “code of ethics” within the meaning of Section 406 of the Sarbanes-Oxley Act of 2002 and Item 406 of Regulation S-K. If we make any amendment to, or waiver from, a provision of our Code of Conduct that we are required to disclose under SEC rules, we intend to satisfy that disclosure requirement by posting such information to our website at www.ardelyx.com. The contents of our websites are not intended to be incorporated by reference into this Form 10-K or in any other report or document we file with the SEC, and any references to our websites are intended to be inactive textual references only. Insider Trading Policy and Procedures We have an insider trading compliance policy and procedures governing the purchase, sale and other dispositions of our securities that applies to all of our personnel, including directors, officers, employees and other covered persons. We believe that our insider trading compliance policy and procedures are reasonably designed to promote compliance with insider trading laws, rules and regulations, and listing standards applicable to us. A copy of our Trading Policy is filed as Exhibit 19.1 to this Form 10-K. 96 Table of Conten t s PART IV ITEM 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES (a) The following documents are filed as part of this report: 1. Financial Statements See Index to Financial Statements at Item 8 herein. 2. Financial Statement Schedules All schedules are omitted because they are not applicable or the required information is shown in the financial statements or notes thereto. 3. Exhibits See the Exhibit Index immediately following this page. ITEM 16. FORM 10-K SUMMARY None. 97 Table of Conten t s Exhibit Index Exhibit Number Incorporated by Reference Filed Herewith Exhibit Description Form Date Number 3.1 Amended and Restated Certificate of Incorporation 8-K 6/24/2014 3.1 3.2 Certificate of Amendment to Amended and Restated Certificate of Incorporation 8-K 6/20/2023 3.1 3.3 Amended and Restated Bylaws 8-K 6/24/2014 3.2 4.1 Reference is made to Exhibits 3.1 and 3.2 4.2 Form of Common Stock Certificate S-1/A 6/18/2014 4.2 4.3 Description of the Registrant’s Securities Registered Pursuant to Section 12 of the Securities Exchange Act of 1934 10-K 3/8/2021 4.4 10.1(a) Termination Agreement, dated June 2, 2015, by and between AstraZeneca AB and Ardelyx, Inc. 10-Q 8/12/2015 10.1 10.1(b) Amendment No. 1 to Termination Agreement and to Manufacturing and Supply Agreement, dated November 2, 2015 by and between AstraZeneca AB and Ardelyx, Inc. 10-K 3/4/2016 10.1(d) 10.2(a) Lease, dated August 8, 2008, by and between 34175 Ardenwood Venture, LLC and Ardelyx, Inc. S-1 5/19/2014 10.4(a) 10.2(b) First Amendment to Lease, dated December 20, 2012, by and between 34175 Ardenwood Venture, LLC and Ardelyx, Inc. S-1 5/19/2014 10.4(b) 10.2(c) Second Amendment to Lease, dated September 5, 2014, by and between Ardelyx, Inc. and 34175 Ardenwood Venture, LLC 8-K 9/9/2014 10.1 10.2(d) Third Amendment to Lease, dated April 28, 2016, by and between Ardelyx, Inc. and 34175 Ardenwood Venture, LLC 10-Q 8/8/2016 10.3 10.2(e) Fourth Amendment to Lease, dated May 25, 2021, by and between Ardelyx, Inc. and 34175 Ardenwood Venture, LLC 10-K 3/2/2023 10.2(e) 10.2(f) Fifth Amendment to Lease, dated May 25, 2021, by and between Ardelyx, Inc. and 34175 Ardenwood Venture, LLC 8-K 6/1/2021 10.1 10.2(g) Sixth Amendment to Lease, dated May 25, 2021, by and between Ardelyx, Inc. and 34175 Ardenwood Venture, LLC. 8-K 10/9/2024 10.2 10.3(a) Lease Agreement, dated December 30, 2020, by and between Ardelyx, Inc. and Prospect Fifth Ave, LLC. 10-K 3/8/2021 10.31 10.3(b) Amendment Number 2 to Lease Agreement by and between Ardelyx, Inc, and Prospect Fifth Avenue, LLC. 10-Q 5/2/2024 10.3(b) 10.3(c) Amendment Number 3 to Lease Agreement by and between Ardelyx, Inc, and Prospect Fifth Avenue, LLC. 10-Q 5/2/2024 10.3(c) 10.4 Lease Agreement, dated October 3, 2024, by and between Ardelyx, Inc. and BMR-Pacific Research Center LP. 8-K 10/9/2024 10.1 10.5# Ardelyx, Inc. Amended and Restated 2014 Equity Incentive Award Plan. 10-Q 8/1/2024 10.1 10.6# Ardelyx, Inc. Amended and Restated 2014 Employee Stock Purchase Plan. 10-Q 8/1/2024 10.2 10.7(a)# Ardelyx, Inc. 2008 Stock Incentive Plan, as amended S-1 5/19/2014 10.5(a) 10.7(b)# Form of Stock Option Grant Notice and Stock Option Agreement under the 2008 Stock Incentive Plan, as amended S-1 5/19/2014 10.5(b) 10.7(c)# Form of Restricted Stock Purchase Grant Notice and Restricted Stock Purchase Agreement under the 2008 Stock Incentive Plan, as amended S-1 5/19/2014 10.5(c) 10.8(a)# Ardelyx, Inc. Amended and Restated 2014 Equity Incentive Award Plan 10-Q 8/1/2024 10.1 10.8(b)# Form of Stock Option Grant Notice and Stock Option Agreement under the 2014 Equity Incentive Award Plan S-1/A 6/9/2014 10.6(b) 10.8(c)# Form of Restricted Stock Award Agreement and Restricted Stock Unit Award Grant Notice under the 2014 Equity Incentive Award Plan S-1/A 6/9/2014 10.6(c) 98 Table of Conten t s Exhibit Number Incorporated by Reference Filed Herewith Exhibit Description Form Date Number 10.9# Ardelyx, Inc. Amended and Restated 2014 Employee Stock Purchase Plan 10-Q 8/1/2024 10.2 10.10(a)# Ardelyx, Inc. 2016 Employment Commencement Incentive Plan 10-K 2/22/2024 10.7(a) 10.10(b)# Form of Stock Option Grant Notice and Stock Option Agreement under the 2016 Employment Commencement Incentive Plan S-8 11/10/2016 99.2 10.10(c)# Form of Restricted Stock Unit Award Grant Notice and Restricted Stock Unit Award Agreement under the 2016 Employment Commencement Incentive Plan S-8 11/10/2016 99.3 10.10(d)# Form of Restricted Stock Award Grant Notice and Restricted Stock Award Agreement under the 2016 Employment Commencement Incentive Plan S-8 11/10/2016 99.4 10.11 Registration Rights Agreement by and among Ardelyx, Inc. and the investors signatory thereto, dated June 2, 2015 S-3 7/13/2015 99.1 10.12 Registration Rights Agreement by and among Ardelyx, Inc. and the investors signatory thereto, dated July 14, 2016 10-Q 8/8/2016 10.2 10.13# Form of Indemnification Agreement for directors and officers S-1/A 6/9/2014 10.7 10.14# Amended and Restated Executive Employment Agreement, dated June 6, 2014, by and between Ardelyx, Inc. and Michael Raab S-1/A 6/9/2014 10.8 10.15# Offer Letter, dated December 28, 2009, by and between Ardelyx, Inc. and David Rosenbaum, Ph.D. S-1/A 6/9/2014 10.13 10.16(a)# Second Amended and Restated Change in Control and Severance Agreement by and between Ardelyx, Inc. and David P. Rosenbaum, Ph.D. 10-Q 5/8/2018 10.1 10.16(b)# Amendment Number One to Second Amended and Restated Change in Control Severance Agreement and Retention Agreement dated December 1, 2021 between Ardelyx, Inc. and David Rosenbaum 10-K 2/28/2022 10.20 10.17# Offer Letter, dated November 21, 2012, by and between Ardelyx, Inc. and Elizabeth Grammer, Esq. S-1/A 6/9/2014 10.14 10.18# Second Amended and Restated Change in Control and Severance Agreement by and between Ardelyx, Inc. and Elizabeth Grammer. 10-Q 5/8/2018 10.0 10.19# Offer Letter, dated April 27, 2020, by and between Ardelyx, Inc. and Susan Rodriguez 10-Q 8/6/2020 10.1 10.20# Change in Control Severance Agreement dated June 2, 2020, by and between Ardelyx, Inc. and Susan Rodriguez 10-Q 8/6/2020 10.2 10.21# Offer Letter, dated June 2, 2020, by and between Ardelyx, Inc. and Justin Renz 10-Q 8/6/2020 10.3 10.22# Change in Control Severance Agreement, dated June 8, 2020, by and between Ardelyx, Inc. and Justin Renz 10-Q 8/6/2020 10.4 10.23(a)# Second Amended and Restated Non-Employee Director Compensation Program 10-Q 8/4/2022 10.3 10.23(b)# Third Amended and Restated Non-Employee Director Compensation Program 10-K 2/22/2024 10.20(b) 10.24# Offer Letter, dated February 13, 2024 by and between Ardelyx, Inc. and Michael Kelliher. 10-Q 5/2/2024 10.29 10.25# Offer Letter, dated July 25, 2024 by and between Ardelyx, Inc. and Eric Foster. 10-Q 10/31/2024 10.6 10.26† Commercial Supply Agreement, dated August 7, 2024 and effective as of July 23, 2024, by and between Ardelyx, Inc. and Catalent. 8-K 8/12/2024 10.1 10.27† Commercial Supply Agreement, dated October 25, 2024, by and among Ardelyx, Inc., Hovione Farmaciência, S.A. and Hovione, LLC. 10-Q 10/31/2024 10.2 99 Table of Conten t s Exhibit Number Incorporated by Reference Filed Herewith Exhibit Description Form Date Number 10.28(a)†† License Agreement, dated November 27, 2017, by and between Kyowa Hakko Kirin Co., Ltd. and Ardelyx, Inc. 10-K 3/14/2018 10.35 10.28(b) Amendment Number 1 to License Agreement, dated as of November 27, 2017, by and among Ardelyx, Inc., and Kyowa Kirin Co., Ltd. 10-K 3/2/2023 10.21(b) 10.28(c)†† Amendment Number 2 to License Agreement, dated as of April 11, 2022, by and among Ardelyx, Inc., and Kyowa Kirin Co., Ltd. 8-K 4/11/2022 99.1 10.29†† License Agreement, dated December 11, 2017, by and between Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. and Ardelyx, Inc. 10-K 3/14/2018 10.36 10.30†† Royalty and Sales Milestone Interest Acquisition Agreement dated June 29, 2022, by and between Ardelyx, Inc. and Healthcare Royalty Partners IV, L.P. 10-Q 8/4/2022 10.1 10.31(a) Loan and Security Agreement dated February 23, 2022, by and between Ardelyx, Inc. and SLR Investment Corp. 10-Q 5/5/2022 10.1 10.31(b) First Amendment to the Loan and Security Agreement dated August 1, 2022, by and between Ardelyx, Inc. and SLR Investment Corp. 10-Q 8/4/2022 10.2 10.31(c) Second Amendment to the Loan and Security Agreement dated February 9, 2023, by and between Ardelyx, Inc. and SLR Investment Corp. 10-K 3/2/2023 10.24(c) 10.31(d) Third Amendment to the Loan and Security Agreement dated October 17, 2023, by and between Ardelyx, Inc. and SLR Investment Corp. 8-K 10/18/2023 10.1 10.31(e) Fourth Amendment to the Loan and Security Agreement dated October 29, 2024, by and between Ardelyx, Inc. and SLR Investment Corp. 10-Q 10/31/2024 10.5 10.32 Exit Fee Agreement dated February 23, 2022, by and between Ardelyx, Inc. and SLR Investment Corp. 10-Q 5/5/2022 10.2 10.33 Exit Fee Agreement, dated May 16, 2018, by and between the Company and Solar Capital Ltd. and Western Alliance Bank 10-Q 8/7/2018 10.2 10.34(a)†† Manufacturing Services Agreement, dated May 18, 2020, between Ardelyx, Inc. and Patheon Pharmaceuticals Inc. 10-Q 8/6/2020 10.5 10.34(b)†† First Amendment to the Manufacturing Services Agreement dated February 27, 2023, between Ardelyx, Inc. and Patheon Pharmaceuticals Inc. 10-K 3/2/2023 10.27(b) 10.35 Open Market Sales Agreement, dated January 18, 2023 between Ardelyx, Inc. and Jefferies LLC. S-3 1/19/2023 1.2 19.1 Arde lyx , Inc. I nsider Trading Com pliance Pol ic y and Procedures — X 23.1 Consent of Independent Registered Public Accounting Firm — X 31.1 Certification of Principal Executive Officer Required Under Rule 13a-14(a) and 15d-14(a) of the Securities Exchange Act of 1934, as amended — X 31.2 Certification of Principal Financial Officer Required Under Rule 13a-14(a) and 15d-14(a) of the Securities Exchange Act of 1934, as amended — X 32.1 Certification of Principal Executive Officer and Principal Financial Officer Required Under Rule 13a‑14(b) of the Securities Exchange Act of 1934, as amended, and 18 U.S.C §1350 — X 97.1 Policy for Recovery of Erroneously Awarded Compensation 10-K 2/22/2024 97.1 101.SCH Inline XBRL Taxonomy Extension Schema Document — X 101.CAL Inline XBRL Taxonomy Extension Calculation Linkbase Document — X 101.DEF Inline XBRL Taxonomy Extension Definition Linkbase Document — X 100 Table of Conten t s Exhibit Number Incorporated by Reference Filed Herewith Exhibit Description Form Date Number 101.LAB Inline XBRL Taxonomy Extension Label Linkbase Document — X 101.PRE Inline XBRL Taxonomy Extension Presentation Linkbase Document — X _______________________________ † Confidential treatment granted as to portions of this Exhibit. The confidential portions of this Exhibit have been omitted and are marked by asterisks. †† Certain portions of this exhibit have been redacted pursuant to Item 601(b)(10) of Regulation S-K. A copy of the omitted portions will be furnished supplementally to the Securities and Exchange Commission upon request. # Indicates management contract or compensatory plan. 101 Table of Conten t s SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. Ardelyx, Inc. Date: February 20, 2025 By: /s/ Joseph Reilly Joseph Reilly Senior Vice President and Chief Accounting Officer (Principal Accounting Officer) POWER OF ATTORNEY Each person whose individual signature appears below hereby authorizes and appoints Michael Raab, Justin Renz, and Joseph Reilly, and each of them, with full power of substitution and resubstitution and full power to act without the other, as his or her true and lawful attorney-in-fact and agent to act in his or her name, place and stead and to execute in the name and on behalf of each person, individually and in each capacity stated below, and to file any and all amendments to this annual report on Form 10-K and to file the same, with all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and every act and thing, ratifying and confirming all that said attorneys-in-fact and agents or any of them or their or his substitute or substitutes may lawfully do or cause to be done by virtue thereof. 102 Table of Conten t s Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated. Signature Title Date /s/ Michael Raab President, Chief Executive Officer and Director (Principal Executive Officer) February 20, 2025 Michael Raab /s/ Justin Renz Chief Financial and Operations Officer (Principal Financial Officer) February 20, 2025 Justin Renz /s/ Joseph Reilly Chief Accounting Officer (Principal Accounting Officer) February 20, 2025 Joseph Reilly /s/ David Mott Chairman of the Board of Directors February 20, 2025 David Mott /s/ Robert Bazemore Director February 20, 2025 Robert Bazemore /s/ William Bertrand, Jr. Director February 20, 2025 William Bertrand, Jr., J.D. /s/ Muna Bhanji Director February 20, 2025 Muna Bhanji, R.Ph /s/ Onaiza Cadoret-Manier Director February 20, 2025 Onaiza Cadoret-Manier /s/ Richard Rodgers Director February 20, 2025 Richard Rodgers 103 Table of Conten t s SUMMARY OF ABBREVIATED TERMS Throughout this 2024 Form 10-K, we have used terms which are defined below: 340B Program Public Health Service’s 340B Drug Pricing Program HCR Agreement Royalty and Sales Milestone Interest Acquisition Agreement AAKP American Association of Kidney Patients HHS Department of Health and Human Services ACA Affordable Care Act HIPAA Health Insurance Portability and Accountability Act of 1996, as amended, and regulations promulgated thereunder AI Technologies Artificial intelligence, machine learning and certain automated decision-making technologies HRSA Health Resources and Services Administration AMP average manufacturer price IBS-C irritable bowel syndrome with constipation ANDA abbreviated New Drug Application IND Investigational New Drug API active pharmaceutical ingredient IRA Inflation Reduction Act of 2022 AstraZeneca AstraZeneca AB IRB institutional review board ASU Accounting Standards Update Jefferies Jefferies, LLC CCPA California Consumer Privacy Act, as amended by the California Privacy Rights Act Kyowa Kirin Kyowa Kirin Co., Ltd. cGMP current Good Manufacturing Practice Knight Knight Therapeutics, Inc. CKD chronic kidney disease MDRP Medicaid Drug Rebate Program CME Chicago Mercantile Exchange METiS METiS Therapeutics, Inc. CMO contract manufacturing organization MHLW Ministry of Health, Labour and Welfare CMS Centers for Medicare & Medicaid Services MIPPA Medicare Improvements for Patients and Providers Act CRO contract research organization OLC Oxylanthanum Carbonate Customers collectively, major wholesalers, specialty pharmacies and GPOs (IBSRELA) and specialty wholesaler (XPHOZAH) NCE new chemical entity DPF EU-US Data Privacy Framework NDA New Drug Application EEA European Economic Area NH3 sodium hydrogen exchange 3 ESPP Employee Stock Purchase Plan NMPA National Medical Products Administration ESRD End-Stage Renal Disease NOL net operating loss ESRD PPS End-Stage Renal Disease Prospective Payment System NMQF National Minority Quality Forum EU Patent Package European Patent Package Non-FAMP Non-Federal Average Manufacturer Price FASB Financial Accounting Standards Board R&D research and development FDA Food and Drug Administration REMS Risk Evaluation and Mitigation Strategy FFDCA Federal Food, Drug, and Cosmetic Act RSU restricted stock units Fosun Pharma Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. SLR SLR Investment Corp. FSS Federal Supply Schedule SEC Securities and Exchange Commission FTC Federal Trade Commission SOFR Secured Overnight Financing Rate GCP Good Clinical Practice TDAPA Transitional Drug Add-on Payment Adjustment GDPR European Union General Data Protection Regulation UPC European Unified Patent Court GLP Good Laboratory Practice U.S. United States GPO group purchasing organization USPTO U.S. Patent and Trademark Office GTN gross-to-net VA Department of Veterans Affairs HCR HealthCare Royalty Partners IV, L.P. 104