ARDELYX, INC. Files 2023 Annual Report on Form 10-K

TL;DR

<b>ARDELYX, INC. filed its 2023 10-K report detailing financial performance and business operations.</b>

AI Summary

ARDELYX, INC. (ARDX) filed a Annual Report (10-K) with the SEC on February 22, 2024. ARDELYX, INC. reported total revenue of $183 million for the fiscal year ended December 31, 2023. The company's revenue for the fiscal year 2023 was primarily generated from Product revenue, License revenue, Product Supply Revenue, and Collaborative Development. ARDELYX, INC. filed its annual report on Form 10-K for the fiscal year ended December 31, 2023. The filing covers the period from January 1, 2023, to December 31, 2023. The company's principal executive offices are located at 34175 Ardenwood Blvd., Fremont, CA 94555.

Why It Matters

For investors and stakeholders tracking ARDELYX, INC., this filing contains several important signals. This 10-K filing provides a comprehensive overview of ARDELYX, INC.'s financial health and strategic direction for the fiscal year 2023, crucial for investors assessing the company's performance and future prospects. The detailed financial data and business segments outlined in the report are essential for understanding ARDELYX, INC.'s revenue streams and operational activities, informing investment decisions.

Risk Assessment

Risk Level: — ARDELYX, INC. shows moderate risk based on this filing. The company's financial performance and future prospects are subject to the inherent risks and uncertainties of the pharmaceutical industry, including regulatory approvals, market acceptance, and competition, as detailed in their 10-K filing.

Analyst Insight

Investors should review the detailed financial statements and risk factors in the 10-K to assess ARDELYX, INC.'s long-term viability and growth potential.

Revenue Breakdown

Key Numbers

• 183 — Total Revenue (Fiscal year ended December 31, 2023)
• 2023-12-31 — Fiscal Year End (Report period)
• 2024-02-22 — Filing Date (Date of submission)

Key Players & Entities

• ARDELYX, INC. (company) — Filer name
• ARDX (company) — Ticker symbol
• 2023 (date) — Fiscal year end
• 34175 Ardenwood Blvd. (location) — Business address
• Fremont, CA 94555 (location) — Business address
• 2024-02-22 (date) — Filing date

FAQ

Key Dates

• 2023-12-31: Fiscal Year End — Marks the end of the reporting period for the 10-K.
• 2024-02-22: Filing Date — Date the 10-K was officially filed with the SEC.

Key Financial Figures

• $0.0001 — ich Registered Common Stock, par value $0.0001 per share ARDX The Nasdaq Global Market
• $3.39 — on stock on the Nasdaq Global Market of $3.39 per share was $ 724,838,738 . The numb
• $846.2 million — 2023, we had an accumulated deficit of $846.2 million. We expect to continue to incur opera
• $2.3 million — the Knight Agreement, Knight paid us a $2.3 million non-refundable, one-time payment in Mar
• $16.7 million — ialization milestones, or approximately $16.7 million at the currency exchange rate on Decemb
• $0.7 million — nge rate on December 31, 2023, of which $0.7 million has been received and recognized as rev
• $30.0 million — 17 Kyowa Kirin Agreement, we received a $30.0 million upfront payment from Kyowa Kirin, and w
• $55.0 million — and we may be entitled to receive up to $55.0 million in total development and regulatory mil
• $35.0 million — ent and regulatory milestones, of which $35.0 million has been received and recognized as rev
• $60.3 million — ialization milestones, or approximately $60.3 million at the currency exchange rate on Decemb
• $40.0 million — in agreed to pay us up to an additional $40.0 million which has been received and recognized

Filing Documents

• ardx-20231231.htm (10-K) — 2211KB
• ardelyxinc2016employmentco.htm (EX-10.7(A)) — 175KB
• thirdamendedandrestatednon.htm (EX-10.20(B)) — 25KB
• consentofindependentregist.htm (EX-23.1) — 6KB
• ardx-20231231xex311.htm (EX-31.1) — 10KB
• ardx-20231231xex312.htm (EX-31.2) — 10KB
• ardx-20231231xex321.htm (EX-32.1) — 6KB
• policyforrecoveryoferroneo.htm (EX-97.1) — 29KB
• ardx-20231231_g1.jpg (GRAPHIC) — 3KB
• 0001628280-24-006393.txt (&nbsp;) — 11096KB
• ardx-20231231.xsd (EX-101.SCH) — 81KB
• ardx-20231231_cal.xml (EX-101.CAL) — 91KB
• ardx-20231231_def.xml (EX-101.DEF) — 359KB
• ardx-20231231_lab.xml (EX-101.LAB) — 1001KB
• ardx-20231231_pre.xml (EX-101.PRE) — 637KB
• ardx-20231231_htm.xml (XML) — 1529KB

Business

Business 3 Item 1A.

Risk Factors

Risk Factors 19 Item 1B. Unresolved Staff Comments 52 I tem 1C. C ybersecurity 52 Item 2.

Properties

Properties 53 Item 3.

Legal Proceedings

Legal Proceedings 53 Item 4. Mine Safety Disclosures 54 PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 55 Item 6. [Reserved] 55 Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 55 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 72 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 73 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 110 Item 9A.

Controls and Procedures

Controls and Procedures 110 Item 9B. Other Information 113 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspection 113 PART III Item 10. Directors, Executive Officers and Corporate Governance 114 Item 11.

Executive Compensation

Executive Compensation 114 Item 12.

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

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 114 Item 13. Certain Relationships and Related Transactions, and Director Independence 114 Item 14. Principal Accounting Fees and Services 114 PART IV Item 15. Exhibits, Financial Statement Schedules 115 Item 16. Form 10-K Summary 115

Signatures

Signatures 119 2 Table of Contents

BUSINESS

ITEM 1. BUSINESS Overview We are a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. We developed a unique and innovative platform that enabled the discovery of new biological mechanisms and pathways to develop potent, and efficacious therapies that minimize the side effects and drug-drug interactions frequently encountered with traditional, systemically absorbed medicines. The first molecule we discovered and developed was tenapanor, a minimally absorbed, first-in-class, oral, small molecule therapy. Tenapanor, branded as IBSRELA , is approved in the U.S. for the treatment of adults with irritable bowel syndrome with constipation (IBS-C). Tenapanor, branded as XPHOZAH , was approved by the U.S. Food and Drug Administration (U.S. FDA) on October 17, 2023, to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy. We also have a development stage asset, RDX013 for adult patients with CKD and/or heart failure with hyperkalemia, or elevated serum potassium, and a discovery phase asset, RDX020 for adult patients with metabolic acidosis, a serious electrolyte disorder, in patients with CKD. Since commencing operations in October 2007, substantially all our efforts have been dedicated to our research and development (R&D) activities, including developing tenapanor and developing our proprietary drug discovery and design platform, as well as commercialization activities, including the marketing and sales of IBSRELA and XPHOZAH. We realized our first product sales of IBSRELA in March 2022 and realized our first product sales of XPHOZAH in November 2023. As of December 31, 2023, we had an accumulated deficit of $846.2 million. We expect to continue to incur operating losses for the fores

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View this 10-K filing on SEC EDGAR