Ardelyx Reports First Quarter 2025 Financial Results and Provides Business Update

Company reports $74.1 million in Q1 total revenue, reflecting 61% growth year-over-year

IBSRELA net product sales revenue of $44.4 million; XPHOZAH net product sales revenue of $23.4 million 

Company ends Q1 with $214.0 million in cash, cash equivalents and investments

Conference call scheduled for 4:30 PM Eastern Time

WALTHAM, Mass., May 01, 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 first quarter ended March 31, 2025 and provided a business update.

“Ardelyx delivered an outstanding first quarter, generating $74 million in total revenue and advancing our key strategic priorities,” said Mike Raab, president and chief executive officer of Ardelyx. “As IBSRELA enters its third full year on the market, it achieved exceptional year-over-year growth of 57%, a testament to the significant clinical value it delivers and the strength of our commercial strategy. XPHOZAH also posted strong year-over-year growth, despite ongoing disruption in the dialysis community, underscoring the high unmet need among patients and the momentum built by the team in 2024. The results affirm our confidence in XPHOZAH’s long-term potential and the important and expanding impact on care for patients with chronic kidney disease on dialysis. Importantly, we continued to thoughtfully manage our operating expenses, preserving a strong balance sheet, and positioned the company for success and value creation as we execute on our mission to improve the lives of patients with serious diseases.”

Raab continued, “Looking ahead to the next quarter and the remainder of 2025, we remain sharply focused on the strategic priorities fueling our momentum: accelerating commercial growth for IBSRELA, deepening the adoption and impact of XPHOZAH, building a pipeline of innovative therapies, and maintaining a disciplined financial performance. We are confident in our ability to continue delivering meaningful results for patients, healthcare providers and shareholders.”

IBSRELA® (tenapanor) records $44.4 million in net product sales revenue in Q1 2025U.S. net product sales revenue for IBSRELA during the first quarter of 2025 was $44.4 million, reflecting significant year-over-year growth of approximately 57%. The strong growth was driven by increases across key demand indicators, including total writers and new and refill prescriptions.

Ardelyx continues to expect full-year 2025 U.S. net product sales revenue for IBSRELA to be between $240.0 and $250.0 million.

XPHOZAH® (tenapanor) records $23.4 million net product sales revenue during Q1 2025U.S. net product sales revenue for XPHOZAH during the first quarter of 2025 was $23.4 million, driven by strong commercial momentum and execution. Net sales revenue during this period reflects the release of $3.8 million of prior periods’ estimated product returns for XPHOZAH, based on assumptions from actual returns history and other data supporting an expectation of minimal returns. Excluding the returns reserve release, net sales revenue for XPHOZAH grew 30% compared to the first quarter of 2024.

Other Corporate Developments

• In April, the company announced the appointment of Merdad Parsey, M.D. Ph.D., to its Board of Directors
• In April, the company announced the appointment of Laura A. Williams, M.D., M.P.H., as the company’s first Chief Patient Officer.
• In February, the company announced the approval of tenapanor in China for hyperphosphatemia. Ardelyx earned a $5.0 million milestone payment from Fosun Pharma following the approval.

First Quarter 2025 Financial Results

• Cash Position: As of March 31, 2025, the company had total cash, cash equivalents and short-term investments of $214.0 million, as compared to total cash, cash equivalents and short-term investments of $250.1 million as of December 31, 2024.
• Revenues: Total revenue for the quarter ended March 31, 2025 was $74.1 million, compared to $46.0 million in total revenue during the quarter ended March 31, 2024, reflecting increased net product sales and licensing revenue.

- IBSRELA U.S. net product sales revenue was $44.4 million, compared to $28.4 million during the same period of 2024.

- XPHOZAH U.S. net product sales revenue was $23.4 million, compared to $15.2 million during the same period of 2024.

- Product supply revenue was $0.3 million, compared to $2.1 million during the same period of 2024.

- Licensing revenue was $5.0 million, compared to $17 thousand during the same period of 2024. The increase is related to a $5.0 million milestone from Fosun Pharma following the approval of tenapanor for hyperphosphatemia in China.

- Non-cash royalty revenue related to the sale of future royalties was $1.0 million, compared to $0.4 million during the same period of 2024.

• R&D Expenses: Research and development expenses were $14.9 million for the quarter ended March 31, 2025, compared to $10.6 million for the quarter ended March 31, 2024. The increase was primarily related to increased engagement with the scientific and medical communities.
• SG&A Expenses: Selling, general and administrative expenses were $83.2 million for the quarter ended March 31, 2025, compared to $53.0 million for the quarter ended March 31, 2024. The increase was primarily related to increased costs associated with the ongoing commercialization of IBSRELA and XPHOZAH.
• Net Loss: Net loss for the quarter ended March 31, 2025 was $41.1 million, or $(0.17) per share, compared to net loss of $26.5 million, or $(0.11) per share, for the quarter ended March 31, 2024. The net loss for the first quarter of 2025 included share-based compensation expense of $12.1 million and non-cash interest expense related to the sale of future royalties of $2.1 million.

Conference Call DetailsThe company will host a conference call today, May 1, 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://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