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Ardelyx Reports First Quarter 2026 Financial Results and Provides Business Update

globenewswire.com

Ardelyx Reports First Quarter 2026 Financial Results and Provides Business Update Q1 2026 total product revenue of $93.4 million, reflecting 38% growth year-over-year

IBSRELA Q1 2026 revenue growth of 58% year-over-year to $70.1 million; Reiterating guidance of $410-$430 million

Strong financial position with $238.1 million in cash, cash equivalents and investments as of March 31, 2026

Conference call scheduled for 4:30 PM Eastern Time

WALTHAM, Mass., April 30, 2026 (GLOBE NEWSWIRE) -- Ardelyx Inc. (Nasdaq: ARDX), (“Ardelyx” or the “Company”) a commercial-stage biopharmaceutical company focused on the development and commercialization of innovative medicines that meet significant unmet medical needs, today reported financial results for the first quarter ended March 31, 2026, and provided a business update.

“In the first quarter of 2026, Ardelyx continued our strong commercial execution which coupled with our strengthening cash position allows us to conduct multiple IBSRELA clinical trials, advance development of our next-generation NHE3 inhibitor, RDX10531, and purposefully explore various avenues to build a significant and sustainable pipeline of important medicines,” said Mike Raab, President and Chief Executive Officer of Ardelyx. “IBSRELA is the cornerstone for the company we’re building and is on the path to becoming a blockbuster by achieving at least one billion dollars in revenue in 2029 with continued strong growth thereafter. We are in a position of financial strength, providing flexibility to allocate capital across the business, accelerate commercial momentum, and drive intrinsic long-term value for the Company, our patients, and our shareholders.”

Product Revenue

Revenue for IBSRELA ® (tenapanor) during the first quarter of 2026 was $70.1 million, reflecting year-over-year growth of approximately 58%. The growth was driven by increases across key demand indicators, including total writers and new and refill prescriptions and continued improvement to prescription pull-through.

Revenue for XPHOZAH ® (tenapanor) during the first quarter of 2026 was $23.3 million driven by a strong increase in paid prescriptions.

2026 Revenue Guidance

Ardelyx reiterates its full-year 2026 revenue guidance:

Advancing a Pipeline of Important Medicines

Other Corporate Developments

First Quarter 2026 Financial Results

Conference Call Details

The company will host a conference call today, April 30, 2026, at 4:30 PM ET to discuss today’s announcement. To participate in the conference call, please dial (877) 346-6112 (domestic) or +1 (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://ardelyx.com/, and will be available on the website following the call.

IMPORTANT SAFETY INFORMATION (IBSRELA)

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

Risk of Serious Dehydration in Pediatric Patients

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 <1%), flatulence (3% vs 1%) and dizziness (2% vs <1%).

INDICATION

IBSRELA (tenapanor) is indicated for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in adults.

Please see full Prescribing Information, including Boxed Warning, for additional risk information.

IMPORTANT SAFETY INFORMATION (XPHOZAH)

CONTRAINDICATIONS

XPHOZAH is contraindicated in:

WARNINGS AND PRECAUTIONS

Diarrhea

Patients may experience severe diarrhea. Treatment with XPHOZAH should be discontinued in patients who develop severe diarrhea.

MOST COMMON ADVERSE REACTIONS

Diarrhea, which occurred in 43-53% of patients, was the only adverse reaction reported in at least 5% of XPHOZAH-treated patients with CKD on dialysis across trials. The majority of diarrhea events in the XPHOZAH-treated patients were reported to be mild-to-moderate in severity and resolved over time, or with dose reduction. Diarrhea was typically reported soon after initiation but could occur at any time during treatment with XPHOZAH. Severe diarrhea was reported in 5% of XPHOZAH-treated patients in these trials.

INDICATION

XPHOZAH (tenapanor), 30 mg BID, is indicated 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.

For additional safety information, please see full Prescribing Information.

About Ardelyx

Ardelyx is a commercial-stage biopharmaceutical company focused on the development and commercialization of innovative medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA ® (tenapanor) and XPHOZAH ® (tenapanor). The company’s pipeline includes the Phase 3 development of IBSRELA for chronic idiopathic constipation (CIC) and RDX10531, a next-generation NHE3 inhibitor with potential application across multiple therapeutic areas. Ardelyx works with partners to develop and commercialize our products outside of the United States. For more information, please visit https://ardelyx.com/ and connect with us on X (formerly known as Twitter), LinkedIn and Facebook.

Forward Looking Statements

To the extent that statements contained in this press release are not descriptions of historical facts regarding Ardelyx, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor of the Private Securities Reform Act of 1995, including Ardelyx’s current expectations regarding: the long term potential for Ardelyx’s existing commercial products; opportunities for continued IBSRELA growth, including our expectations and timing for achieving one billion in revenue; our U.S. net product sales revenue guidance for IBSRELA and XPHOZAH for full year 2026; and our expectations and timing regarding pipeline development activities, including enrollment in and expected topline readout of the Phase 3 ACCEL trial, the potential for additional patent life for IBSRELA as a result of ongoing pediatric clinical trials and RDX10531’s potential across multiple therapeutic areas. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that are in some cases beyond our control, that could cause actual outcomes or results to differ materially from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, uncertainties associated with the development of, regulatory process for, and commercialization of drugs in the U.S. and internationally. Ardelyx undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ardelyx's business in general, please refer to Ardelyx's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on April 30, 2026, and its future current and periodic reports to be filed with the Securities and Exchange Commission.

Investor Contact:

Lisa Caperelli

lcaperelli@ardelyx.com