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Dec 31, 2022
Ardelyx Q4 2022 Earnings Report
Ardelyx reported financial results for Q4 2022 and provided a business update.
Key Takeaways
Ardelyx reported Q4 net product sales for IBSRELA of $8.7 million and ended the quarter with $123.9 million in cash and investments. The company is preparing for NDA resubmission for XPHOZAH in early Q2 2023.
IBSRELA finished 2022 with $15.6 million in net product sales, including $8.7 million in Q4 2022.
XPHOZAH NDA resubmission is expected in early Q2 2023.
The company ended Q4 with approximately $123.9 million in cash and investments.
A Type A meeting with the FDA was productive, providing information required to complete the NDA resubmission for XPHOZAH.
Revenue by Segment
Forward Guidance
Ardelyx is focused on building growth and momentum for IBSRELA, executing plans for a successful launch of XPHOZAH (if approved), and creating opportunities to expand the business.
Positive Outlook
- Continued success with IBSRELA, demonstrating growth in prescriptions.
- Preparation for the potential launch of XPHOZAH in the second half of 2023, if approved.
- Positive outcome of the appeal process for XPHOZAH.
- Productive Type A meeting with the FDA, providing a path to bring XPHOZAH to patients.
- Amendment of the debt financing agreement with SLR Investment Corp. to potentially extend the interest-only period.
Challenges Ahead
- Uncertainties associated with the commercialization of drugs.
- Uncertainties regarding the FDA regulatory process.
- Risk of delays in the NDA submission for XPHOZAH.
- Dependence on FDA approval for XPHOZAH for future revenue generation.
Historical Earnings Impact
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Avg. Return Before/After Earnings
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