Financial Performance - The company has incurred losses each year since its inception in October 2007, with an accumulated deficit of $885.3 million as of December 31, 2024[105]. - The company generated limited revenue from product sales and may never achieve profitability for a full fiscal year[113]. - The net loss for 2024 was $39.136 million, a reduction from a net loss of $66.067 million in 2023, indicating improved financial performance[374]. - Total revenues for 2024 reached $333.615 million, a significant increase of 168% compared to $124.456 million in 2023[374]. - Product sales, net, surged to $319.196 million in 2024, up from $82.526 million in 2023, reflecting a growth of 287%[374]. - The net loss for the year ended December 31, 2024, was $39,136,000, a significant improvement from a net loss of $66,067,000 in 2023, and $67,207,000 in 2022[379]. - Net cash used in operating activities decreased to $44,809,000 in 2024 from $89,717,000 in 2023, indicating improved operational efficiency[379]. Product Development and Commercialization - The company began commercializing its first product, IBSRELA, in March 2022, and XPHOZAH in November 2023[105]. - The ability to generate product revenue from IBSRELA and XPHOZAH will depend on market size, pricing, and reimbursement availability[114]. - The company faces uncertainties regarding the market acceptance and commercial success of both IBSRELA and XPHOZAH[116]. - The company is dependent on the regulatory approval and market acceptance of IBSRELA and XPHOZAH, with potential adverse side effects impacting commercial success[126]. - The company relies on third-party manufacturers for IBSRELA and XPHOZAH, and any disruptions in their supply could materially harm commercialization efforts[133]. Financing and Capital Requirements - The company will require additional financing to support the growth of IBSRELA and XPHOZAH and to build a product pipeline[111]. - The company has drawn a total of $150 million from the loan agreement, with an option to draw an additional $50 million by June 30, 2025[141]. - The company’s future funding requirements will depend on various factors, including product revenue generation and collaboration partnerships[112]. - The company recorded total reductions to gross product sales for variable consideration amounting to $109.9 million during 2024[369]. - The total estimate of reserves for variable consideration was $27.3 million as of December 31, 2024[369]. Regulatory and Compliance Risks - The company is subject to ongoing regulatory obligations and continued regulatory review for its products IBSRELA and XPHOZAH, which may result in significant additional expenses[186]. - The company must comply with complex regulations regarding the promotion of its products for unapproved uses, which could lead to substantial fines or sanctions if violated[198]. - The company is subject to interest rate risk through its borrowings under the 2022 Loan Agreement, which bear interest at SOFR plus a spread based on its public debt rating[354]. - The company may incur significant costs to comply with new laws and regulations, which could increase operating expenses[166]. Market and Competitive Landscape - The company may face substantial competition in the biotechnology and pharmaceutical industries, with competitors potentially developing products faster or more successfully[143]. - IBSRELA competes with three main prescription products for IBS-C: Linzess, Amitiza, and Trulance, along with generic lubiprostone and over-the-counter treatments[144]. - XPHOZAH is indicated for reducing serum phosphorus in adults with CKD on dialysis, with various phosphate binders available in the U.S. market[145]. - There are at least four phosphate binders currently in development, which may pose additional competition for XPHOZAH[146]. Intellectual Property and Legal Risks - The company relies on a combination of legal measures to protect its intellectual property, but these measures provide only limited protection against competitors[222]. - The success of the company depends on its ability to obtain and enforce patents, and failure to do so could harm its competitive position and profitability[221]. - The company may face significant legal costs and damages if accused of infringing third-party patents, which could delay product development and commercialization[230]. - The company may encounter substantial costs in enforcing patent rights in foreign jurisdictions, which could divert attention from other business aspects[249]. Operational Challenges - The company may experience difficulties in managing growth due to limited managerial, operational, and financial resources[149]. - The company faces risks related to attracting and retaining qualified personnel, which is critical for achieving development and commercial objectives[156]. - The company may face challenges in maintaining relationships with single-source manufacturers, which could expose it to supply chain risks[137]. - The company has experienced significant volatility in its stock price, influenced by various factors including regulatory actions and market conditions[258]. Financial Position and Cash Management - As of December 31, 2024, the company had cash, cash equivalents, and short-term investments totaling $250.1 million[353]. - Cash and cash equivalents rose significantly to $64.932 million in 2024, up from $21.470 million in 2023, marking an increase of 203%[372]. - Total current assets increased to $356.452 million in 2024, compared to $246.111 million in 2023, representing a growth of 45%[372]. - The company does not currently intend to pay dividends on its common stock for the foreseeable future, relying instead on stock price appreciation for shareholder returns[275].

Financial Performance - Unaudited U.S. net product sales revenue of IBSRELA (tenapanor) for Q4 2024 was approximately $54 million, and approximately $158 million for the full year 2024[8] - Unaudited U.S. net product sales revenue of XPHOZAH (tenapanor) for Q4 2024 was approximately $57 million, and approximately $161 million for the full year 2024[8] - As of December 31, 2024, the company had cash, cash equivalents, and short-term investments of approximately $250 million[3] Financial Data Disclosure - The preliminary financial data is subject to adjustment and may differ materially in the audited financial statements[4] - The preliminary financial data is the responsibility of the company's management and has not been audited or reviewed by Ernst & Young LLP[5]

Ardelyx, Inc. (NASDAQ:ARDX) Q3 2024 Earnings Conference Call October 31, 2024 4:30 PM ET Company Participants Caitlin Lowie - Vice President of Corporate Communications & Investor Relations Michael Raab - President & Chief Executive Officer Eric Foster - Chief Commercial Officer Justin Renz - Chief Financial Officer & Chief Operations Officer Conference Call Participants Louise Chen - Cantor Fitzgerald Dennis Ding - Jefferies Roanna Ruiz - Leerink Partners Laura Chico - Wedbush Joseph Thome - TD Cowen Ryan ...

Table of Contents Non-accelerated filer ☐ Smaller reporting company ☐ UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-36485 ARDELYX, INC. (Exact Name of Registrant as Specif ...

Exhibit 99.1 Ardelyx Reports Third Quarter 2024 Financial Results and Provides Business Update IBSRELA generates $40.6 million in net product sales revenue; Company expects full year 2024 IBSRELA net sales revenue to be between $145 and $150 million XPHOZAH generates $51.5 million in net product sales revenue Company ends Q3 with approximately $190 million in cash, cash equivalents and investments Conference call scheduled for 4:30 PM Eastern Time WALTHAM, Mass., October 31, 2024 - Ardelyx, Inc. (Nasdaq: AR ...

NEW YORK, Sept. 18, 2024 (GLOBE NEWSWIRE) -- WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of securities of Ardelyx, Inc. (NASDAQ: ARDX) between October 31, 2023 and July 1, 2024, both dates inclusive (the “Class Period”), of the important October 15, 2024 lead plaintiff deadline. SO WHAT: If you purchased Ardelyx securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement. WHAT ...

NEW YORK, Sept. 16, 2024 (GLOBE NEWSWIRE) -- Levi & Korsinsky, LLP notifies investors in Ardelyx, Inc. ("Ardelyx" or the "Company") (NASDAQ: ARDX) of a class action securities lawsuit. CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of Ardelyx investors who were adversely affected by alleged securities fraud between October 31, 2023 and July 1, 2024. Follow the link below to get more information and be contacted by a member of our team: https://zlk.com/pslra-1/ardelyx-lawsuit-submission-form ...

NEW YORK, Sept. 11, 2024 (GLOBE NEWSWIRE) -- Levi & Korsinsky, LLP notifies investors in Ardelyx, Inc. ("Ardelyx" or the "Company") (NASDAQ: ARDX) of a class action securities lawsuit. CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of Ardelyx investors who were adversely affected by alleged securities fraud between October 31, 2023 and July 1, 2024. Follow the link below to get more information and be contacted by a member of our team: https://zlk.com/pslra-1/ardelyx-lawsuit-submission-form ...

Core Viewpoint - A class action lawsuit has been filed against Ardelyx, Inc. for alleged violations of the Securities Exchange Act, specifically related to misleading statements about its product XPHOZAH and its revenue potential [1][2]. Group 1: Lawsuit Details - The lawsuit pertains to investors who purchased Ardelyx securities between October 31, 2023, and July 1, 2024 [1]. - The Schall Law Firm is representing the investors and encourages those who suffered losses to contact them before October 15, 2024 [1]. - The class has not yet been certified, meaning potential class members are not yet represented by an attorney [2]. Group 2: Allegations Against Ardelyx - The complaint alleges that Ardelyx made false and misleading statements regarding its XPHOZAH phosphorus inhibitor and its inclusion in the Transitional Drug Add-on Payment Adjustment program (TDAPA) [2]. - Ardelyx claimed it was pursuing inclusion of XPHOZAH in the TDAPA, but had not made a firm decision on the application [2].

NEW YORK, Sept. 10, 2024 (GLOBE NEWSWIRE) -- The Gross Law Firm issues the following notice to shareholders of Ardelyx, Inc. (NASDAQ: ARDX). Shareholders who purchased shares of ARDX during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff is not required to partake in any recovery. CONTACT US HERE: https://securitiesclasslaw.com/securities/ardelyx-loss-submission-form/?id=101256&from=3 CLASS PERIOD: October 31, 2023 to Ju ...