Ardelyx Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update

Company achieved significant commercial progress in 2024, finishing with total revenue of $333.6 million, including $319.2 million in U.S. Net Product Sales

Company reaffirms combined peak sales of IBSRELA and XPHOZAH of $1.75 Billion

Company ended FY 2024 with $250.1 million in cash, cash equivalents and investments

Conference call scheduled for 8:00 AM Eastern Time

WALTHAM, Mass., Feb. 20, 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 fourth quarter and full year ended December 31, 2024, and provided a business update.

“Ardelyx enters 2025 in a position of strength, evidenced by significant year-over-year revenue growth for IBSRELA in 2024 and a strong first full year of XPHOZAH commercialization, driven by consistently high levels of commercial excellence, meaningful long-term potential for our existing commercial products and a strong cash position to support future growth opportunities,” said Mike Raab, president and chief executive officer of Ardelyx. “We are focused on our key priorities to grow IBSRELA, execute the XPHOZAH strategy, build a pipeline of important medicines, continue to deliver a strong financial performance, and, most importantly, achieve our mission of bringing novel therapies to patients with unmet medical needs.”

IBSRELA® (tenapanor) finishes 2024 with $158.3 million in net product sales revenueU.S. net product sales revenue for IBSRELA in 2024 was $158.3 million, including $53.8 million in net product sales revenue in the fourth quarter, approximately 32% growth compared to the third quarter of 2024. Ardelyx currently expects full year 2025 U.S. net product sales revenue for IBSRELA to be between $240 and $250 million. Ardelyx continues to expect IBSRELA to achieve greater than ten percent market share at peak and generate more than $1 billion in annual U.S. net product sales revenue before patent term expiration.

XPHOZAH® (tenapanor) records $160.9 million net product sales revenue in first full year of commercializationU.S. net product sales revenue for the first full calendar year of commercialization of XPHOZAH was $160.9 million, including $57.2 million in net product sales revenue during the fourth quarter of 2024. At peak, Ardelyx currently expects XPHOZAH to achieve $750 million in annual U.S. net product sales revenue before patent term expiration.

Other Corporate DevelopmentsThe company recently released its 2024 Environmental, Social and Governance (ESG) report, demonstrating the company’s commitment and progress towards initiatives and best practices that build a more equitable and sustainable organization. The report is available on the company’s website.

Full Year 2024 Financial Results

• Cash Position: As of December 31, 2024, the company had total cash, cash equivalents and short-term investments of $250.1 million, compared to total cash, cash equivalents and short-term investments of $184.3 million as of December 31, 2023. During the quarter ended December 31, 2024, the company drew $49.7 million in net proceeds under its term loan with SLR Investment Corp.
• Revenue: Total revenue for the year ended December 31, 2024, was $333.6 million, compared to $124.5 million in total revenue in 2023, driven by increases in net product sales revenue.
  • IBSRELA U.S. net product sales revenue was $158.3 million, compared to $80.1 million in 2023.
  • XPHOZAH U.S. net product sales revenue was $160.9 million, compared to $2.5 million in 2023.
  • Product supply revenue was $11.6 million, compared to $6.1 million in 2023.
  • Licensing revenue was $78 thousand, compared to $35.8 million in 2023. 2023 licensing revenue included $30.0 million in payments from Kyowa Kirin following the approval of tenapanor for hyperphosphatemia in Japan, as well as $5.0 million in payments from Fosun Pharma related to the acceptance of the New Drug Application for tenapanor for the control of serum phosphorus in adult patients with CKD on dialysis in China and the FDA approval of XPHOZAH in the U.S.
  • Non-cash royalty revenue related to the sale of future royalties was $2.7 million with no comparable revenue during the same period of 2023.
• R&D Expenses: Research and development expenses were $52.3 million for the year ended December 31, 2024, compared to $35.5 million for the year ended December 31, 2023, primarily related to increased medical engagement with the scientific communities in the areas of gastroenterology and nephrology and pediatric clinical trials.
• SG&A Expenses: Selling, general and administrative expenses were $258.7 million for the year ended December 31, 2024 compared to $134.4 million for the year ended December 31, 2023. The increase in selling, general and administrative expenses was primarily due to increased costs associated with the company’s field-based sales team expansion for IBSRELA and the launch of XPHOZAH.
• Net Loss: Net loss for the year ended December 31, 2024, was $39.1 million, or $(0.17) per share, compared to net loss of $66.1 million, or $(0.30) per share, for the year ended December 31, 2023. The net loss for the full year 2024 included share-based compensation expense of $37.4 million and non-cash interest expense related to the sale of future royalties of $7.1 million.

Conference Call DetailsThe company will host a conference call today, February 20, 2025, at 8:00 AM 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, www.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