Ardelyx secures China approval for kidney disease drug

WALTHAM, Mass. - Ardelyx, Inc. (NASDAQ:ARDX), a biopharmaceutical company currently valued at $1.22 billion, announced today that China’s Center for Drug Evaluation of the National Medical (TASE:BLWV) Products Administration has approved its New Drug Application for tenapanor. According to InvestingPro analysis, the company appears undervalued despite its stock declining 18.55% in the past week. This drug is designed to control serum phosphorus in dialysis patients with chronic kidney disease (CKD) who do not respond well to or cannot tolerate phosphorus binders.

The approval of tenapanor, which will be marketed under the Chinese trade name Wan Ti Le, triggers a $5 million milestone payment to Ardelyx from its Chinese partner, Shanghai Fosun Pharmaceutical (TADAWUL:2070) Industrial Development Co. Ltd. (Fosun Pharma). With a strong gross profit margin of 69.16% and impressive revenue growth of 168.06% in the last twelve months, Ardelyx’s agreement with Fosun Pharma could potentially bring in up to $100 million more in developmental and commercialization milestones, as well as tiered royalty payments on net sales that range from the mid-teens to 20 percent.

The decision by the Chinese authorities is based on data from two studies conducted by Fosun Pharma, which included a single pharmacokinetic study and a pivotal trial involving CKD patients on dialysis. These studies were supported by clinical data from Ardelyx. Fosun Pharma holds exclusive rights to market and sell tenapanor in China, Hong Kong, and Macau.

Mike Raab, president and CEO of Ardelyx, expressed gratitude towards Fosun Pharma for their support in achieving approval and looks forward to the collaboration as the treatment becomes available to patients in China. According to data at the end of 2023, over one million patients in China require maintenance hemodialysis, with a growth rate of approximately 12% annually. Among these patients, 76% suffer from hyperphosphatemia, yet only a small percentage achieve the target phosphate levels set by Chinese healthcare standards.

Tenapanor, known as XPHOZAH in other markets, is a first-in-class phosphate absorption inhibitor that works locally in the gut. It is taken as a single tablet twice daily, with diarrhea being the most common side effect reported in clinical trials. For deeper insights into Ardelyx’s financial health, growth prospects, and 8 additional key ProTips, visit InvestingPro, where you’ll find comprehensive analysis in our exclusive Pro Research Report, part of our coverage of over 1,400 US stocks.

This news is based on a press release statement from Ardelyx, Inc.

In other recent news, Ardelyx Inc . reported its fourth-quarter 2024 earnings, exceeding market expectations with an earnings per share (EPS) of $0.02, compared to the forecasted $0.01. The company also surpassed revenue forecasts, reporting $116.1 million against an anticipated $108.58 million. This strong performance was driven by significant sales growth for products such as IBZRILLA and EXPOSA. Ardelyx’s net product sales for IBZRILLA reached $53.8 million, marking a 32% growth from the previous quarter, and EXPOSA’s sales were $57.2 million in the fourth quarter. Despite these positive results, H.C. Wainwright maintained a Neutral rating on Ardelyx, with a steady price target of $5.50. Analyst Ed Arce noted challenges ahead, especially concerning the exclusion of EXPOSA from Medicare Part D starting January 2025. Ardelyx’s management aims for EXPOSA to achieve annual U.S. net sales revenue of $750 million before its patent expires in April 2034. The company plans to increase SG&A expenses by approximately $10 million per quarter in 2025 to support growth initiatives, including expanding its field access manager team.

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