Full Press Release Details
Q3 2026 total product revenue of $125.5 million, reflecting 19% growth year-over-year
IBSRELA Q3 2026 revenue growth of 23% year-over-year to $96.3 million
Strong financial position with $285.3 million in cash, cash equivalents and investments as of September 30, 2026
Enrollment completed ahead of schedule in Phase 3 Clinical Trial in CIC
Conference call scheduled for 4:30 PM Eastern Time
WALTHAM, Mass., Nov. 03, 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 third quarter ended September 30, 2026, and provided a business update.
“Our third quarter results reflect the strength of the foundation we’ve built,” said Mike Raab, President and Chief Executive Officer of Ardelyx. “IBSRELA year-over-year growth of 23% is the engine driving total product revenue of over $125 million for the quarter. With our robust tenapanor intellectual property portfolio, and our fully enrolled Phase 3 ACCEL trial for CIC, the value of IBSRELA continues to strengthen. Finally, with over $285 million in cash and investments, and a disciplined capital allocation strategy, we are well positioned to create and deliver significant long-term value.”
Product Revenue Revenue for IBSRELA® (tenapanor) during the third quarter of 2026 was $96.3 million, reflecting year-over-year growth of 23%. The growth was driven by increases in total writers and total prescriptions.
Revenue for XPHOZAH® (tenapanor) during the third quarter of 2026 was $29.2 million, reflecting year-over-year growth of 7%.
2026 Full-Year Guidance and Outlook
• Full-year 2026 revenue guidance for IBSRELA reiterated to be between $350 and $370 million.
• Full-year 2026 revenue guidance for XPHOZAH reiterated to be between $110 and $120 million.
• Full-year 2026 operating expense guidance reiterated to be below $500 million.
• IBSRELA long-term guidance of achieving $1 billion in annual revenue remains.
Pipeline Updates
• The Company has completed enrollment ahead of schedule in its Phase 3 clinical trial, ACCEL, evaluating tenapanor for the treatment of chronic idiopathic constipation (CIC) in adults. The Company is on track to announce topline data in the second half of 2027.
Corporate Updates
• The United States Patent and Trademark Office notified the Company that on November 10, 2026, they will issue U.S. Patent No. 12,788,750 titled, “Oral Formulation of a Therapeutic Compound”, with an expiration date of December 6, 2041. This patent will cover the Company’s commercial formulations of both IBSRELA and XPHOZAH.
• In October at the American College of Gastroenterology annual scientific meeting, the Company presented real world data showing that gastrointestinal-related healthcare resource utilization dropped after adults with IBS-C started IBSRELA.
• Also in October, at the American Society of Nephrology Kidney meeting, the Company presented real-world data showing reductions in serum phosphate following XPHOZAH initiation in adults on dialysis with or without phosphate binders.
Third Quarter 2026 Financial Results
• Cash Position: As of September 30, 2026, the Company had total cash, cash equivalents and short-term investments of $285.3 million, compared to total cash, cash equivalents and short-term investments of $264.7 million as of December 31, 2025.
• Revenues: Total product revenue for the quarter ended September 30, 2026 was $125.5 million, compared to $105.5 million for the quarter ended September 30, 2025, reflecting 19% growth, driven by increased demand.
• R&D Expenses: Research and development expenses were $25.2 million for the quarter ended September 30, 2026, compared to $18.1 million for the quarter ended September 30, 2025. The increase was primarily related to investments in the ACCEL Phase 3 trial for CIC.
• SG&A Expenses: Selling, general and administrative expenses were $93.9 million for the quarter ended September 30, 2026, compared to $83.6 million for the quarter ended September 30, 2025. The increase was related to deliberate investments to address the access barriers and drive future adoption of IBSRELA.
• Net Loss: Net loss for the quarter ended September 30, 2026 was $0.7 million, or $(0.00) per share, compared to net loss of $1.0 million, or $(0.00) per share, for the quarter ended September 30, 2025. The net loss for the third quarter of 2026 included share-based compensation expense of $15.1 million.
Conference Call Details The company will host a conference call today, November 3, 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)
| WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS | |
| IBSRELA is contraindicated in patients less than 6 years of age; in nonclinical studies in young juvenile rats administration of tenapanor caused deaths presumed to be due to dehydration. Avoid use of IBSRELA in patients 6 years to less than 12 years of age. The safety and effectiveness of IBSRELA have not been established in patients less than 18 years of age. |
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 PRECAUTIONS Risk 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 <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:
• Pediatric patients under 6 years of age
• Patients with known or suspected mechanical gastrointestinal obstruction
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 its 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; our efforts towards profitability; opportunities for continued IBSRELA growth, including our expectation for achieving $1 billion in annual revenue; our U.S. net product sales revenue and operating expense guidance for full year 2026; our capital allocation strategy; the scope and duration of our intellectual property protection; and our expectations and timing regarding pipeline development activities, including the expected topline readout of the Phase 3 ACCEL trial. 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, Ardelyx’s ability to successfully commercialize IBSRELA and XPHOZAH; coverage and reimbursement decisions by government and commercial payors, including prior authorization and step-edit requirements; market acceptance of our products and the effectiveness of our commercial initiatives; competition, including from generic products; Ardelyx’s ability to achieve its financial guidance and long-term revenue expectations and reach profitability when anticipated; the timing, progress and results of clinical trials, including the ACCEL trial; the risk that real-world analyses may not predict future results or outcomes in broader patient populations; Ardelyx’s ability to obtain, maintain and enforce its intellectual property rights; reliance on third-party manufacturers and suppliers; and uncertainties regarding U.S. and foreign regulatory processes. Forward-looking statements speak only as of the date of this press release, and 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 November 3, 2026, and its future current and periodic reports to be filed with the Securities and Exchange Commission.
Investor Contact: Lisa Caperelli SVP, Investor Relations & Corporate Communications lcaperelli@ardelyx.com
| Ardelyx, Inc. Condensed Balance Sheets (Unaudited) (in thousands) | |||||
| September 30, 2026 | December 31, 2025 | ||||
| Assets | |||||
| Cash and cash equivalents | $ | 46,317 | $ | 67,999 | |
| Short-term investments | 239,021 | 196,690 | |||
| Accounts receivable | 93,441 | 71,848 | |||
| Prepaid commercial manufacturing | 17,161 | 14,479 | |||
| Inventory | 157,559 | 123,107 | |||
| Property and equipment, net | 1,570 | 2,184 | |||
| Right-of-use assets | 3,692 | 4,795 | |||
| Prepaid and other assets | 28,764 | 20,502 | |||
| Total assets | $ | 587,525 | $ | 501,604 | |
| Liabilities and stockholders’ equity | |||||
| Accounts payable | $ | 33,657 | $ | 19,235 | |
| Accrued compensation and benefits | 17,592 | 19,108 | |||
| Current portion of operating lease liability | 1,579 | 1,479 | |||
| Deferred revenue | 19,196 | 14,905 | |||
| Accrued expenses and other liabilities | 71,880 | 51,218 | |||
| Long-term debt | 252,360 | 202,834 | |||
| Deferred royalty obligation related to the sale of future royalties | 27,215 | 25,876 | |||
| Total stockholders’ equity | 164,046 | 166,949 | |||
| Total liabilities and stockholders’ equity | $ | 587,525 | $ | 501,604 |
| Ardelyx, Inc. Condensed Statements of Operations (Unaudited) (in thousands, except share and per share amounts) | |||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
| 2026 | 2025 | 2026 | 2025 | ||||||||||||
| Revenues | |||||||||||||||
| Product sales, net | |||||||||||||||
| IBSRELA | $ | 96,286 | $ | 78,158 | $ | 252,603 | $ | 187,606 | |||||||
| XPHOZAH | 29,169 | 27,357 | 84,354 | 75,800 | |||||||||||
| Total product sales, net | 125,455 | 105,515 | 336,957 | 263,406 | |||||||||||
| Product supply revenue | 1,380 | — | 3,710 | 6,439 | |||||||||||
| Licensing revenue | 216 | 25 | 363 | 5,065 | |||||||||||
| Non-cash royalty revenue related to the sale of future royalties | 604 | 4,789 | 1,975 | 7,195 | |||||||||||
| Total revenues | 127,655 | 110,329 | 343,005 | 282,105 | |||||||||||
| Costs and operating expenses | |||||||||||||||
| Cost of sales(1) | 4,539 | 3,982 | 15,109 | 28,688 | |||||||||||
| Research and development | 25,199 | 18,067 | 71,490 | 48,671 | |||||||||||
| Selling, general and administrative | 93,894 | 83,612 | 297,601 | 250,822 | |||||||||||
| Total costs and operating expenses | 123,632 | 105,661 | 384,200 | 328,181 | |||||||||||
| Income (loss) from operations | 4,023 | 4,668 | (41,195 | ) | (46,076 | ) | |||||||||
| Interest expense | (5,880 | ) | (5,796 | ) | (16,436 | ) | (14,343 | ) | |||||||
| Non-cash interest expense related to the sale of future royalties | (1,502 | ) | (2,188 | ) | (4,086 | ) | (6,478 | ) | |||||||
| Other income, net | 2,712 | 2,449 | 6,862 | 6,667 | |||||||||||
| Loss before provision for income taxes | (647 | ) | (867 | ) | (54,855 | ) | (60,230 | ) | |||||||
| Provision for income taxes | 90 | 102 | 208 | 962 | |||||||||||
| Net loss | $ | (737 | ) | $ | (969 | ) | $ | (55,063 | ) | $ | (61,192 | ) | |||
| Net loss per share of common stock - basic and diluted | $ | (0.00 | ) | $ | (0.00 | ) | $ | (0.22 | ) | $ | (0.25 | ) | |||
| Shares used in computing net loss per share - basic and diluted | 250,007,187 | 241,908,407 | 247,991,715 | 240,165,744 | |||||||||||
| (1) Prior year amounts have been reclassified to conform to the current year presentation. |