Ardelyx Reports Third Quarter 2025 Financial Results and Provides Corporate Update

Q3 2025 product revenue of $105.5 million reflects 15% year-over-year growth

IBSRELA® Q3 revenue of $78.2 million reflects 92% year-over-year growth; IBSRELA guidance raised, 2025 revenue expected to be between $270-275 million

XPHOZAH® Q3 revenue of $27.4 million, up 9% compared to Q2 2025

Company announces pipeline program for next-generation NHE3 inhibitor; Potential application across multiple therapeutic areas

Conference call scheduled for 4:30 PM Eastern Time

WALTHAM, Mass., Oct. 30, 2025 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today reported financial results for the third quarter ended September 30, 2025 and provided a corporate update.

“This quarter’s results highlight the growth of our business as we advance toward year-end and position Ardelyx for an even stronger performance in 2026,” said Mike Raab, president and chief executive officer of Ardelyx. “IBSRELA continues to outperform, driven by sustained demand from IBS-C patients seeking a differentiated treatment option and by the effectiveness of our targeted commercial execution. Our strategy translated into expanded patient adoption, accelerated revenue growth and increased conviction for the long-term value of this franchise. For XPHOZAH, we are encouraged by the consistent growth, despite the dynamic market environment. The progress we are making underscores the agility and discipline of our team, as well as the strength of our commercial model. Finally, the announcement of RDX10531, our next generation NHE3 inhibitor, underscores our leadership in NHE3 inhibition and represents a pivotal step in building a pipeline of important medicines.”

Raab continued, “Our commercial success and disciplined capital allocation have created a solid financial foundation, enabling us to invest in innovation and long-term growth. Our achievements this quarter demonstrate our commitment to advancing transformative therapies, the efficiency of our execution, and our ability to deliver meaningful and sustained value to patients and shareholders.”

IBSRELA® (tenapanor) records $78.2 million in revenue in Q3 2025IBSRELA’s strong growth continued in the third quarter of 2025, generating $78.2 million in revenue, a 92% increase compared to the same period of 2024 and a 20% increase compared to the second quarter of 2025. IBSRELA saw continued growth in new and total writers as well as new and refill prescriptions driven by strong commercial execution and prescription pull-through. The company expects continued growth of IBSRELA and to generate between $270 and $275 million in IBSRELA revenue for the full-year 2025.

XPHOZAH® (tenapanor) records $27.4 million revenue during Q3 2025U.S. revenue for XPHOZAH during the third quarter of 2025 was $27.4 million, reflecting 9% growth compared to the second quarter of 2025, driven by quarter-over-quarter increases in paid demand prescriptions, total dispenses and total writers. The company expects continued growth in the fourth quarter of 2025 driven by the commercial strategy focusing on patient access, driving clinical conviction among nephrologists and supporting prescription pull-through.

Building a Pipeline of Important MedicinesDuring the third quarter, Ardelyx began the development of RDX10531, a next generation sodium/hydrogen exchanger 3 (NHE3) inhibitor. NHE3 is an antiporter expressed on the apical surface of the small and large intestines and is responsible for absorbing the majority of ingested sodium. The company is currently conducting activities to support an Investigational New Drug (IND) submission to the U.S. Food and Drug Administration for RDX10531 in 2026. 

Other Corporate Developments

• In October, the company announced the appointment of Sue Hohenleitner as Chief Financial Officer to be effective November 4, 2025.
• In August, the company announced the appointment of Edward Conner, M.D. as Chief Medical Officer and John Bishop, Ph.D. as Chief Technical Operations Officer.
• The company had a significant presence at the 2025 Annual Scientific Meeting for the American College of Gastroenterology (ACG 2025) in Phoenix from October 24-29, 2025. The company presented three posters and sponsored a Product Theater.

Third Quarter 2025 Financial Results

• Cash Position: As of September 30, 2025, the company had total cash, cash equivalents and short-term investments of $242.7 million, as compared to total cash, cash equivalents and short-term investments of $250.1 million as of December 31, 2024 and $238.5 million as of June 30, 2025.
• Revenues: Total revenue for the quarter ended September 30, 2025 was $110.3 million, compared to $98.2 million in total revenue during the quarter ended September 30, 2024, primarily reflecting increased IBSRELA revenue, offset by a decline in XPHOZAH revenue.
  • IBSRELA revenue was $78.2 million, compared to $40.6 million during the same period of 2024.
  • XPHOZAH revenue was $27.4 million, compared to $51.5 million during the same period of 2024. The year-over-year decline in revenue is due to the loss of Part D coverage for Medicare patients following the transition of oral only therapies into the Medicare End-Stage Renal Disease Prospective Payment System on January 1, 2025.
  • No product supply revenue was  recorded in the current quarter, compared to $5.3 million during the same period of 2024.
  • Licensing revenue was $25 thousand, compared to $20 thousand during the same period of 2024.
  • Non-cash royalty and milestone revenue related to the sale of future royalties and commercialization milestones was $4.8 million, compared to $0.8 million during the same period of 2024. The current period includes a $3.4 million commercialization milestone from our partner in Japan, Kyowa Kirin Corp.
• R&D Expenses: Research and development expenses were $18.1 million for the quarter ended September 30, 2025, compared to $15.3 million for the quarter ended September 30, 2024.
• SG&A Expenses: Selling, general and administrative expenses were $83.6 million for the quarter ended September 30, 2025, an increase compared to $65.0 million for the quarter ended September 30, 2024 and consistent with SG&A expenses reported during the second quarter of 2025.
• Net Loss: Net loss for the quarter ended September 30, 2025 was $1.0 million, or $(0.00) per share, compared to net loss of $0.8 million, or $(0.00) per share, for the quarter ended September 30, 2024. The net loss for the third quarter of 2025 included non-cash revenue of $4.8 million, share-based compensation expense of $12.7 million and non-cash interest expense related to the sale of future royalties of $2.2 million.

Conference Call DetailsThe company will host a conference call today, October 30, 2025, at 4:30 PM ET to discuss today’s announcement. To participate in the conference call, please dial (877) 346-6112 (domestic) or (848) 280-6350 (international) and ask to be joined into the Ardelyx call. A webcast of the call can also be accessed by visiting the Investor page of the company's website, https://ir.ardelyx.com/, and will be available on the website for 30 days following the call.

IMPORTANT SAFETY INFORMATION (IBSRELA)

CONTRAINDICATIONS

• IBSRELA is contraindicated in patients less than 6 years of age due to the risk of serious dehydration.
• IBSRELA is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction.

WARNINGS AND PRECAUTIONSRisk of Serious Dehydration in Pediatric Patients

• IBSRELA is contraindicated in patients below 6 years of age. The safety and effectiveness of IBSRELA in patients less than 18 years of age have not been established. In young juvenile rats (less than 1 week old; approximate human age equivalent of less than 2 years of age), decreased body weight and deaths occurred, presumed to be due to dehydration, following oral administration of tenapanor. There are no data available in older juvenile rats (human age equivalent 2 years to less than 12 years).
• Avoid the use of IBSRELA in patients 6 years to less than 12 years of age. Although there are no data in older juvenile rats, given the deaths in younger rats and the lack of clinical safety and efficacy data in pediatric patients, avoid the use of IBSRELA in patients 6 years to less than 12 years of age.

Diarrhea Diarrhea was the most common adverse reaction in two randomized, double-blind, placebo-controlled trials of IBS-C. Severe diarrhea was reported in 2.5% of IBSRELA-treated patients. If severe diarrhea occurs, suspend dosing and rehydrate patient.

MOST COMMON ADVERSE REACTIONS The most common adverse reactions in IBSRELA-treated patients (incidence ≥2% and greater than placebo) were: diarrhea (16% vs 4% placebo), abdominal distension (3% vs