Ardelyx Provides Update on Growing Commercial Momentum and 2024 Strategic Priorities - Seite 2

Ardelyx currently expects full-year 2024 U.S. net product sales revenue for IBSRELA to be between $140.0 and $150.0 million.

XPHOZAH (tenapanor) Launch Progress and Preliminary 2023 Revenue
Following approval by the U.S. Food and Drug Administration of XPHOZAH in October 2023 and launch in November 2023, Ardelyx has seen a strong initial response from the nephrology community. U.S. net product sales revenue for the first quarter of commercialization of XPHOZAH is expected to be approximately $2.5 million, subject to adjustment in connection with preparation of audited financial statements.

Strong Cash Position
As of December 31, 2023, the company had total cash, cash equivalents and short-term investments of approximately $184 million (unaudited). Ardelyx had approximately 232 million shares outstanding as of December 31, 2023.

Webcast Details
The company will host a live event and webcast today, January 8, 2024, at 7:00 p.m. ET / 4:00 p.m. PT. The event will include a management update on IBSRELA, the company’s FDA approved treatment for irritable bowel syndrome with constipation (IBS-C), as well as a Key Opinion Leader discussion regarding the IBS-C treatment landscape with Philip Schoenfeld, MD, MS Ed, MSc, Chief (Emeritus) of the Gastroenterology Section at the John D. Dingell VA Medical Center in Detroit, Mich. The webcast can be accessed by visiting the Investor page of the company's website, www.ardelyx.com, and will be available on the website for at least 30 days 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