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Dec 31, 2021
Ardelyx Q4 2021 Earnings Report
Reported fourth quarter and full year financial results, advancing toward launch of IBSRELA® in April 2022.
Key Takeaways
Ardelyx reported a net loss of $36.23 million for the fourth quarter of 2021. The company is preparing for the April 2022 launch of IBSRELA and anticipates becoming a revenue-generating company.
Company is advancing toward launch of IBSRELA in April 2022.
Kyowa Kirin Co. Ltd. announced positive Phase 3 results of tenapanor for hyperphosphatemia in patients on hemodialysis in Japan and plans to file for approval in the second half of 2022.
The company submitted an appeal of the ADL to the Office of New Drugs (“OND”), Center for Drug Evaluation and Research.
The company announced it is paying off the remainder of $25.0 million in principal plus interest outstanding under the Loan and Security agreement.
Forward Guidance
Ardelyx anticipates a response from OND regarding the appeal from the ADL issued by OCHEN, expects the new loan and security agreement with SLR to impact the company’s cash position positively, and expects breakeven and profitability for IBSRELA, which is anticipated to impact shareholder value.
Positive Outlook
- The company plans to launch IBSRELA (tenapanor), the company's FDA approved treatment for irritable bowel syndrome with constipation (IBS-C) in adults, in April of 2022.
- Kyowa Kirin Co. Ltd., (KKC) announced positive Phase 3 results of tenapanor for hyperphosphatemia in patients on hemodialysis in Japan and plans to file for approval in the second half of 2022 with potential regulatory approval in the second half of 2023.
- The company has entered into a new term loan with SLR Investment Corp. for $27.5 million, which provides for two years of interest only payments, and an option for an additional $22.5 million in term loan debt if the company receives FDA approval for XPHOZAH® (tenapanor) by December 31, 2022, and meets certain net revenue criteria and other conditions.
- This further extends the company’s cash position in support of the IBSRELA launch.
- The company is positioned to be a biopharma standout in 2022 with our evolution to a commercial stage company.
Challenges Ahead
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