What changed in this filing

/stocks — the workspaceLOADING

Item 9A. Controls and Procedures

2025-02-20 compared with 2024-02-22 · 154 added, 61 removed, 232 unchanged (48% of the section changed)

1 unchanged sentence

Conclusions Regarding the Effectiveness of Disclosure Controls and Procedures

As of December 31, 2023, management, with the participation of our Chief Executive Officer (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.

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

Table of Conten t s

relationship of possible controls and procedures.

25 unchanged sentences

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 required to be independent with respect to the Company in accordance with the U.S.

We are a public accounting firm registered with the PCAOB and are

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.

20 unchanged sentences

Rule 10b5-1* Non-Rule 10b5-1**

Michael Raab , President and Chief Executive Officer

Adoption December 13, 2023 X

331,300 January 6, 2025

Elizabeth Grammer , Chief Legal Officer

Adoption December 20, 2023 X

131,000 July 16, 2024

Robert Blanks , Chief Regulatory Officer

Adoption December 21, 2023 X

December 20, 2024 X

339,500 June 21, 2024

Laura Williams , Chief Medical Officer

Adoption December 27, 2023 X 79,949 March 27, 2024

* Intended to satisfy the affirmative defense conditions of Rule 10b5-1(c)

2 unchanged sentences

Not Applicable.

Table of Conten t s

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

Directors, Executive Officers, and Corporate Governance.

Information required by this item will be contained in our definitive proxy statement to be filed with the Securities and Exchange Commission on Schedule 14A in connection with our 2024 Annual Meeting of Stockholders (Proxy Statement), which will be filed not later than 120 days after the end of our fiscal year ended December 31, 2023, under the headings “Executive Officers,” “Election of Directors,” “Corporate Governance,” and “ Section 16(a) Beneficial Ownership Reporting Compliance,” and is incorporated herein by reference.

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.

“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.

Executive Compensation.

The information required by this item regarding executive compensation will be incorporated by reference to the information set forth in the sections titled “Executive Compensation” in our Proxy Statement.

“Executive Compensation” section.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.

The information required by this item regarding security ownership of certain beneficial owners and management will be incorporated by reference to the information set forth in the section titled “Security Ownership of Certain Beneficial Owners and Management” and “Equity Compensation Plan Information” in our Proxy Statement.

“Security Ownership of Certain Beneficial Owners and Management” and “Equity Compensation Plan Information” sections.

Certain Relationships and Related Transactions, and Director Independence.

The information required by this item regarding certain relationships and related transactions and director independence will be incorporated by reference to the information set forth in the sections titled “Certain Relationships and Related Party Transactions” and “Election of Directors”, respectively, in our Proxy Statement.

“Certain Relationships and Related Party Transactions” and “Election of Directors” sections.

Principal Accountant Fees and Services.

The information required by this item regarding principal accountant fees and services will be incorporated by reference to the information set forth in the section titled “Principal Accountant Fees and Services” in our Proxy Statement.

“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.

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.

Table of Conten t s

EXHIBITS, FINANCIAL STATEMENT SCHEDULES

6 unchanged sentences

FORM 10-K SUMMARY

Exhibit Index [IN PROCESS]

Table of Conten t s

Exhibit Index

Number Incorporated by Reference Filed

2 unchanged sentences

8-K 6/24/2014 3.1

3.2 C ertificate of Amendment to Amended and Restated Certificate of Incorporation

3.2 Certificate of Amendment to Amended and Restated Certificate of Incorporation

8-K 6/20/2023 3.1

27 unchanged sentences

8-K 6/1/2021 10.1

Number Incorporated by Reference Filed

Exhibit Description Form Date Number

Sixth Amendment to Lease, dated May 25, 2021, by and between Ardelyx, Inc.

and 34175 Ardenwood Venture, LLC.

8-K 10/9/2024

Lease Agreement, dated December 30, 2020, by and between Ardelyx, Inc.

1 unchanged sentence

10-K 3/8/2021 10.31

10.4(a)# Ardelyx, Inc.

Amendment Number 2 to Lease Agreement by and between Ardelyx, Inc, and Prospect Fifth Avenue, LLC.

5/2/2024 10.3(b)

Amendment Number 3 to Lease Agreement by and between Ardelyx, Inc, and Prospect Fifth Avenue, LLC.

5/2/2024 10.3(c)

Lease Agreement, dated October 3, 2024, by and between Ardelyx, Inc.

and BMR-Pacific Research Center LP.

8-K 10/9/2024 10.1

Ardelyx, Inc.

Amended and Restated 2014 Equity Incentive Award Plan.

8/1/2024 10.1

Ardelyx, Inc.

Amended and Restated 2014 Employee Stock Purchase Plan.

8/1/2024 10.2

Ardelyx, Inc.

2008 Stock Incentive Plan, as amended

S-1 5/19/2014 10.5(a)

10.4(b)# Form of Stock Option Grant Notice and Stock Option Agreement under the 2008 Stock Incentive Plan, as amended

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)

10.4(c)# Form of Restricted Stock Purchase Grant Notice and Restricted Stock Purchase Agreement under the 2008 Stock Incentive Plan, as amended

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)

10.5(a)# Ardelyx, Inc.

2014 Equity Incentive Award Plan

S-8 7/14/2014 99.3

10.5(b)# Form of Stock Option Grant Notice and Stock Option Agreement under the 2014 Equity Incentive Award Plan

Ardelyx, Inc.

Amended and Restated 2014 Equity Incentive Award Plan

8/1/2024 10.1

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)

10.5(c)# Form of Restricted Stock Award Agreement and Restricted Stock Unit Award Grant Notice under the 2014 Equity Incentive Award Plan

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)

Table of Conten t s

Number Incorporated by Reference Filed

Exhibit Description Form Date Number

Ardelyx, Inc.

2014 Employee Stock Purchase Plan

S-8 7/14/2014 99.6

10.7(a)# Ardelyx, Inc.

Amended and Restated 2014 Employee Stock Purchase Plan

10-Q 8/1/2024 10.2

Ardelyx, Inc.

2016 Employment Commencement Incentive Plan

10.7(b)# Form of Stock Option Grant Notice and Stock Option Agreement under the 2016 Employment Commencement Incentive Plan

2/22/2024 10.7(a)

Form of Stock Option Grant Notice and Stock Option Agreement under the 2016 Employment Commencement Incentive Plan

S-8 11/10/2016 99.2

10.7(c)# Form of Restricted Stock Unit Award Grant Notice and Restricted Stock Unit Award Agreement under the 2016 Employment Commencement Incentive Plan

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

10.7(d)# Form of Restricted Stock Award Grant Notice and Restricted Stock Award Agreement under the 2016 Employment Commencement Incentive Plan

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

13 unchanged sentences

S-1/A 6/9/2014 10.13

10.13(a)# Second Amended and Restated Change in Control and Severance Agreement by and between Ardelyx, Inc.

Second Amended and Restated Change in Control and Severance Agreement by and between Ardelyx, Inc.

Rosenbaum, Ph.D.

10-Q 5/8/2018 10.1

10.13(b)# Amendment Number One to Second Amended and Restated Change in Control Severance Agreement and Retention Agreement dated December 1, 2021 between Ardelyx, Inc.

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

20 unchanged sentences

10-Q 8/4/2022 10.3

Third Amended and Restated Non-Employee Director Compensation Program

2/22/2024 10.20(b)

Offer Letter, dated February 13, 2024 by and between Ardelyx, Inc.

and Michael Kelliher.

5/2/2024 10.29

Offer Letter, dated July 25, 2024 by and between Ardelyx, Inc.

and Eric Foster.

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

Commercial Supply Agreement, dated October 25, 2024, by and among Ardelyx, Inc., Hovione Farmaciência, S.A.

and Hovione, LLC.

10/31/2024 10.2

Table of Conten t s

Number Incorporated by Reference Filed

Exhibit Description Form Date Number

Third Amended and Restated Non-Employee Director Compensation P rogram

10.21(a)†† License Agreement, dated November 27, 2017, by and between Kyowa Hakko Kirin Co., Ltd.

License Agreement, dated November 27, 2017, by and between Kyowa Hakko Kirin Co., Ltd.

and Ardelyx, Inc.

10-K 3/14/2018 10.35

10.21(b) Amendment Number 1 to License Agreement, dated as of November 27, 2017, by and among Ardelyx, Inc., and Kyowa Kirin Co., Ltd.

3/2/2023 10.21(c)

10.21(c)†† Amendment Number 2 to License Agreement, dated as of April 11, 2022, by and among Ardelyx, Inc., and Kyowa Kirin Co., Ltd.

Amendment Number 1 to License Agreement, dated as of November 27, 2017, by and among Ardelyx, Inc., and Kyowa Kirin Co., Ltd.

3/2/2023 10.21(b)

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

5 unchanged sentences

10-Q 8/4/2022 10.1

10.24(a) Loan and Security Agreement dated February 23, 2022, by and between Ardelyx, Inc.

Loan and Security Agreement dated February 23, 2022, by and between Ardelyx, Inc.

and SLR Investment Corp.

10-Q 5/5/2022 10.1

10.24(b) First Amendment to the Loan and Security Agreement dated August 1, 2022, by and between Ardelyx, Inc.

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

10.24(c) Second Amendment to the Loan and Security Agreement dated February 9, 2023, by and between Ardelyx, Inc.

Second Amendment to the Loan and Security Agreement dated February 9, 2023, by and between Ardelyx, Inc.

and SLR Investment Corp.

3/2/2023 10.24(c)

T hird A mendment to the Loan and Security Agreement dated October 17, 2023, by and between Ardelyx , Inc.

Third Amendment to the Loan and Security Agreement dated October 17, 2023, by and between Ardelyx, Inc.

and SLR Investment Corp.

10/18/2023 10.1

Fourth Amendment to the Loan and Security Agreement dated October 29, 2024, by and between Ardelyx, Inc.

and SLR Investment Corp.

10/31/2024 10.5

Exit Fee Agreement dated February 23, 2022, by and between Ardelyx, Inc.

4 unchanged sentences

10-Q 8/7/2018 10.2

10.27(a)†† Manufacturing Services Agreement, dated May 18, 2020, between Ardelyx, Inc.

Manufacturing Services Agreement, dated May 18, 2020, between Ardelyx, Inc.

and Patheon Pharmaceuticals Inc.

10-Q 8/6/2020 10.5

10.27(b)†† First Amendment to the Manufacturing Services Agreement dated February 27, 2023, between Ardelyx, Inc.

First Amendment to the Manufacturing Services Agreement dated February 27, 2023, between Ardelyx, Inc.

and Patheon Pharmaceuticals Inc.

Open Market Sales Agreement, dated August 31, 2021 between Ardelyx, Inc.

and Jefferies LLC.

8-K 8/13/2021 10.1

Open Market Sales Agreement, dated January 18, 2023 between Ardelyx, Inc.

1 unchanged sentence

S-3 1/19/2023 1.2

Arde lyx , Inc.

I nsider Trading Com pliance Pol ic y and Procedures

23.1 Consent of Independent Registered Public Accounting Firm

6 unchanged sentences

101.DEF Inline XBRL Taxonomy Extension Definition Linkbase Document — X

Table of Conten t s

Number Incorporated by Reference Filed

Exhibit Description Form Date Number

101.LAB Inline XBRL Taxonomy Extension Label Linkbase Document — X

6 unchanged sentences

# Indicates management contract or compensatory plan.

Table of Conten t s

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.

1 unchanged sentence

February 20, 2025 By:

/s/ Robert Felsch

Robert Felsch

/s/ Joseph Reilly

Joseph Reilly

Senior Vice President and Chief Accounting Officer

1 unchanged sentence

POWER OF ATTORNEY

Each person whose individual signature appears below hereby authorizes and appoints Michael Raab, Justin Renz, and Robert Felsch, 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.

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.

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.

6 unchanged sentences

February 20, 2025

/s/ Robert Felsch Chief Accounting Officer

/s/ Joseph Reilly

Chief Accounting Officer

(Principal Accounting Officer)

February 20, 2025

Robert Felsch

Joseph Reilly

/s/ David Mott Chairman of the Board of Directors February 20, 2025

8 unchanged sentences

Onaiza Cadoret-Manier

Lundberg Director February 22, 2024

Lundberg, Ph.D.

/s/ Richard Rodgers Director February 20, 2025

Richard Rodgers

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

California Consumer Privacy Act, as amended by the California Privacy Rights Act

Kyowa Kirin Co., Ltd.

current Good Manufacturing Practice

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

collectively, major wholesalers, specialty pharmacies and GPOs (IBSRELA) and specialty wholesaler (XPHOZAH)

NCE new chemical entity

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.

SLR SLR Investment Corp.

FSS Federal Supply Schedule SEC Securities and Exchange Commission

Federal Trade Commission

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.

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