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Mar 31, 2022
Ardelyx Q1 2022 Earnings Report
Reported first quarter financial results and business highlights.
Key Takeaways
Ardelyx reported its first commercial product sales of IBSRELA with $0.5 million in revenue. The company is pursuing FDA approval for XPHOZAH and received notification from the FDA that an advisory committee meeting will be convened. Net loss for the quarter was $28.1 million, or $0.21 per share.
Launched IBSRELA, the first and only NHE3 inhibitor for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults.
Presented additional positive clinical observations of XPHOZAH at the National Kidney Foundation 2022 Spring Clinical Meetings.
Reached an agreement with Kyowa Kirin Co. Ltd. to amend the license agreement for tenapanor in Japan.
The FDA has provided an interim response to Ardelyx’s second level of appeal of the Complete Response Letter (CRL) for XPHOZAH and will convene an advisory committee meeting.
Forward Guidance
The company did not provide specific forward guidance but did mention expectations regarding the timing of Kyowa Kirin’s filing for marketing approval for tenapanor for hyperphosphatemia in Japan and Ardelyx’s expectations regarding the potential timing for Kyowa Kirin’s marketing approval in Japan.
Historical Earnings Impact
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Avg. Return Before/After Earnings
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