Ardelyx (NASDAQ:ARDX) executives said the company entered 2026 with “another significant year of growth” underway, highlighting strong first-quarter demand for its IBS-C product IBSRELA and continued momentum for kidney disease drug XPHOZAH, while also advancing pipeline efforts aimed at expanding tenapanor’s reach and extending the franchise.
Management outlines four priorities as IBSRELA drives growth
President and CEO Mike Raab said the company is focused on four priorities in 2026: “accelerating the growth of IBSRELA, maintaining the XPHOZAH momentum, building and expanding our pipeline, and delivering strong financial results.”
On XPHOZAH, Raab said a “patient-first strategy” continues to guide execution as demand grows and access expands, with the company emphasizing support for patients “irrespective of payer coverage.”
Commercial update: HCP targeting, patient activation, and pull-through initiatives
Chief Commercial Officer Eric Foster said the company built on last year’s commercial momentum, with IBSRELA growing across “total writers, new and refilled prescriptions, and total prescriptions” year-over-year. Foster described IBSRELA as the company’s “main revenue driver,” reiterating 58% year-over-year product revenue growth.
Foster said demand trends were “robust” despite “expected first quarter market dynamics” and a “temporary disruption from 2 severe winter storms.” The commercial strategy, he said, centers on positioning IBSRELA as a first-line option after secretagogue failure, citing internal research that “as many as 77%” of patients on a secretagogue continue to experience symptoms.
Foster outlined key demand drivers for IBSRELA:
- Growing breadth and depth of writing: Ardelyx is focusing on high-writing healthcare providers responsible for about 50% of IBS-C prescriptions, while also expanding prescribing within existing accounts.
- Increasing patient activation: Foster said the company is seeing “robust engagement” across digital and social channels and is exploring new outreach avenues, including a partnership with the LPGA intended to “educate, empower, and mobilize” patients to discuss symptoms and treatment options with physicians.
- Improving pull-through and fulfillment: Ardelyx is expanding field reimbursement manager presence and encouraging prescriptions through the IBSRELA Pharmacy Network, a limited specialty pharmacy group designed to navigate prior authorizations and payer hurdles. Foster said fulfillment rates are higher through the network and that Ardelyx sees “on average an additional refill per year for patients” using it.
For XPHOZAH, Foster said the company’s access efforts drove a 32% increase in total dispenses and a 19% increase in paid prescriptions versus the year-ago quarter, while he noted the overall prescription market declined 10% over the same period. He also said Ardelyx saw increases in writers and prescriptions across non-Medicare segments, supported by targeted sales initiatives and enhanced access messaging.
Pipeline: Phase III CIC trial underway, pediatric strategy, and next-gen NHE3 inhibitor
Raab said Ardelyx now has the “financial flexibility to further invest in our pipeline,” including label expansion efforts for IBSRELA. He highlighted the initiation of the EXHALE Phase III trial evaluating IBSRELA in chronic idiopathic constipation (CIC). Raab said all pre-identified sites were initiated in under four months and are recruiting patients, with Ardelyx “on track to complete enrollment by year-end” and to announce top-line data in the second half of 2027.
In the Q&A, Raab said site activation pace was “wonderful to see” and “on par” with expectations informed by the prior TEMPO program experience, adding that physician and patient enthusiasm is evident and enrollment “continues at pace.”
Raab also discussed a pediatric program evaluating IBSRELA in pediatric IBS-C and functional constipation, describing it as part of a broader tenapanor lifecycle strategy. He said pediatric development is operationally challenging in IBS-C due to symptom subjectivity, but emphasized the program’s safety focus and noted the potential to extend tenapanor’s patent life by six months. “The benefit of that 6 months,” he said, depends on modeled monthly value at peak, adding, “It’s significant.”
Raab also referenced an Orange Book-listed “2099 patent covering the commercial formulations of IBSRELA and XPHOZAH.” In addition, he said Ardelyx’s next-generation NHE3 inhibitor, RDX10531, continues through IND-enabling studies, with the company planning to “work at pace if those studies are positive.”
Separately, Raab said physicians may already be using IBSRELA off-label in CIC, but emphasized Ardelyx cannot promote off-label use. He pointed to the Rome V publication and evolving definitions of constipation-related disorders as part of the rationale for pursuing CIC, describing IBS-C and CIC as a “continuum of care.”
Financial results: revenue growth, higher spending, and debt refinancing
Chief Financial Officer Sue Hohenleitner reported total product revenue of $93.4 million in Q1 2026, up from $67.8 million in Q1 2025, representing 38% growth. IBSRELA revenue was $70.1 million, up 58% year-over-year. Hohenleitner said demand increased despite seasonal dynamics and winter storms, and she said Ardelyx expects IBSRELA revenue to grow quarter-over-quarter for the remainder of 2026.
XPHOZAH revenue was $23.3 million, flat on an as-reported basis. Hohenleitner noted that Q1 2025 included a $3.8 million favorable adjustment related to product returns; excluding that, she said “paid prescriptions of XPHOZAH revenue actually grew 19% year-over-year.”
Expenses increased year-over-year. R&D expenses were $20.2 million versus $14.9 million, which Hohenleitner attributed primarily to development activities for the ACCEL Phase III trial for CIC. SG&A expenses were $102.3 million versus $83.2 million, reflecting commercialization investments behind IBSRELA.
Net loss was $37.6 million, or $0.15 per share, compared with a net loss of $41.1 million, or $0.17 per share, a year earlier. The quarter included $14.2 million of non-cash share-based compensation expense, up from $12.1 million.
Ardelyx ended the quarter with $238.1 million in cash, cash equivalents, and short-term investments. Hohenleitner also said the company refinanced its existing debt with SLR, extending the maturity and interest-only period by two years and lowering the “overall cost of capital and annual interest expenses.” She noted that of the $300 million facility entered in 2022, $200 million has been drawn, with $100 million available for drawdown this year.
Guidance reiterated; capital allocation and profitability trajectory discussed
Hohenleitner reiterated 2026 revenue guidance of $410 million to $430 million for IBSRELA and $110 million to $120 million for XPHOZAH. She said full-year product revenue is expected to grow 38% to 46%, while operating expenses are expected to grow by about 25%.
During the Q&A, Hohenleitner said Ardelyx previously guided to “about $520” million in total operating expenses for 2026, with a ramp as the CIC study enrolls patients, and that the expected CIC spend was “factored into the guidance.”
She also addressed gross-to-net dynamics, saying the company reported “a little over 36.4%” gross-to-net in the first quarter as a blend, and that Q1 is likely the highest quarter due to co-pay assistance dynamics. She reiterated expectations for a blended gross-to-net rate in the “low 30s” for the year.
On cash flow, Hohenleitner said the company is monitoring progress and, with product revenue guidance of roughly $520 million to $550 million and operating expenses at about $520 million, there is “possibility” of reaching cash flow positivity, with updates to come if appropriate.
Raab said Ardelyx is not planning to provide quarterly guidance, emphasizing the company’s focus on executing against annual targets while investing in commercialization and pipeline development.
About Ardelyx (NASDAQ:ARDX)
Ardelyx, Inc (NASDAQ: ARDX) is a clinical‐stage biopharmaceutical company focused on discovering, developing and commercializing targeted small molecule drugs for cardio‐renal and gastrointestinal diseases. The company’s lead marketed product, tenapanor (sold under the brand name XPHOZAH in the United States), is approved for the treatment of hyperphosphatemia in patients with chronic kidney disease on dialysis. Ardelyx’s proprietary approach targets epithelial transporters in the gastrointestinal tract, offering localized activity with limited systemic exposure.
Beyond tenapanor, Ardelyx’s development pipeline includes treatments designed to address other complications in kidney disease and related metabolic disorders.
