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Sep 30, 2021
Ardelyx Q3 2021 Earnings Report
Reported business events and financial results
Key Takeaways
Ardelyx reported $1.2 million in revenue for Q3 2021, primarily from collaborative development with Kyowa Kirin. R&D expenses increased to $23.7 million, and G&A expenses rose to $19.7 million due to commercial infrastructure build-up. The company's net loss for the quarter was $43.6 million, and they had $141.7 million in cash, cash equivalents, and short-term investments as of September 30, 2021.
Presented four posters at the American Society of Nephrology Kidney Week 2021 highlighting positive clinical observations with tenapanor.
Expects to submit a Formal Dispute Resolution Request (FDRR) by the end of the fourth quarter 2021 to appeal the Complete Response Letter (CRL) from the FDA for tenapanor.
Announced results of an End of Review Type A meeting with FDA, noting it did not provide clarity for resubmission of the NDA for tenapanor.
Implemented a restructuring plan in October 2021 to reduce operating costs following the CRL from the FDA.
Forward Guidance
Ardelyx expects to submit a Formal Dispute Resolution Request to appeal the FDA’s issuance of a CRL for its NDA for tenapanor for the control of serum phosphorus in CKD patients on dialysis, and the expected timing thereof, and Ardelyx’s expectations regarding the timing of the completion of the restructuring that it began implementing in October 2021.
Historical Earnings Impact
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Avg. Return Before/After Earnings
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