Ardelyx Reports Third Quarter 2026 Financial Results And Provides Business Update
| 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 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
...
| 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. |
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