NASDAQ$ARDX
Ardelyx Inc · Q4 2021 earnings
Q4 2021 earnings · · Investor relations
Briefing
Reported fourth quarter and full year financial results, advancing toward launch of IBSRELA® in April 2022.
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.
Headline financials
Revenue & EPS history
Ardelyx · Revenue · Quarterly
$1.03M
Revenue by segment
Ardelyx · $35M total across 1 segment · Q4 2022
- Licensing Revenue$35M—100.0%
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.
Tailwinds
- 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.
Headwinds
- The company received an Appeal Denied Letter (“ADL”) from the Office of Cardiology, Hematology, Endocrinology and Nephrology (“OCHEN”) of the U.S. Food and Drug Administration (the “FDA”) in response to its Formal Dispute Resolution Request (“FDRR”) submitted in early December 2021.
- Such forward-looking statements involve substantial risks and uncertainties that could cause Ardelyx’s future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements.
- Such risks and uncertainties include, among others, uncertainties associated with the Formal Dispute Resolution process with the FDA, uncertainties associated with its capital requirements to fund its operations, uncertainties in the commercialization of drugs in the United States, as well as uncertainties in the drug development and regulatory processes in Japan.
- Ardelyx undertakes no obligation to update or revise any forward-looking statements.
- Net loss for the year ended December 31, 2021 was $158.2 million, compared to $94.3 million for the year ended December 31, 2020.
Historical earnings impact
How earnings announcements have historically affected this stock's price.
Avg. return before/after earnings
Based on 20 quarterly earnings reports · overlaid with Q4 2021
+0.0%
Avg return
Earnings day
+2.6%
Avg return
5 days after
+5.2%
Avg return
30 days after
40%
20 / 50 earnings
Positive
+31.9%
Q1 2024
Best reaction
-24.8%
Q1 2025
Worst reaction
| Quarter | Report date | Reaction (Day 0) | +5 days | +30 days |
|---|---|---|---|---|
| Q1 2026 | +6.2% | +12.2% | -4.7% | |
| Q4 2025 | -14.9% | -2.7% | -21.2% | |
| Q3 2025 | +18.6% | +18.8% | +15.8% | |
| Q1 2025 | -24.8% | -32.4% | -32.9% | |
| Q4 2024 | -10.1% | -18.6% | -19.3% | |
| Q3 2024 | +3.4% | -2.9% | -3.7% | |
| Q2 2024 | +9.0% | +9.5% | +11.4% | |
| Q1 2024 | +31.9% | +40.8% | +3.8% | |
| Q4 2023 | +2.1% | +13.8% | -9.4% | |
| Q3 2023 | +8.8% | +11.0% | +24.6% | |
| Q2 2023 | +4.2% | -2.3% | +25.5% | |
| Q1 2023 | +5.9% | -5.6% | -20.7% | |
| Q4 2022 | +30.8% | +34.9% | +64.0% | |
| Q3 2022 | +0.7% | -11.6% | +25.9% | |
| Q2 2022 | +11.5% | +14.9% | +42.5% | |
| Q1 2022 | -10.7% | -20.3% | -26.0% | |
| Q4 2021 | -7.6% | +17.0% | +37.1% | |
| Q3 2021 | -3.4% | -12.1% | +25.9% | |
| Q2 2021 | -1.3% | -9.9% | -10.5% | |
| Q1 2021 | +0.6% | +1.1% | +0.5% | |
| Q4 2020 | -4.8% | +4.5% | +14.2% | |
| Q3 2020 | -6.3% | +1.9% | +10.3% | |
| Q2 2020 | +1.4% | -2.6% | +0.7% | |
| Q1 2020 | +2.2% | +5.0% | -4.2% | |
| Q4 2019 | -7.3% | -9.1% | -12.6% | |
| Q3 2019 | +2.2% | +12.5% | +22.1% | |
| Q2 2019 | -3.8% | -5.1% | +108.1% | |
| Q1 2019 | -4.7% | -4.1% | -22.3% | |
| Q4 2018 | +8.0% | +9.7% | +9.0% | |
| Q3 2018 | -6.7% | -10.6% | -29.4% | |
| Q2 2018 | -7.1% | +0.0% | -7.1% | |
| Q1 2018 | +0.0% | +2.5% | -24.8% | |
| Q4 2017 | -5.0% | -4.5% | -6.2% | |
| Q3 2017 | +2.2% | +4.5% | +8.2% | |
| Q2 2017 | +11.0% | +17.2% | +29.9% | |
| Q1 2017 | -2.2% | -0.8% | -63.4% | |
| Q4 2016 | -2.4% | -1.1% | +13.7% | |
| Q3 2016 | +2.5% | +25.6% | +21.3% | |
| Q2 2016 | -0.8% | -1.9% | +5.8% | |
| Q1 2016 | -0.5% | — | — | |
| Q4 2015 | -5.6% | — | — | |
| Q3 2015 | -4.4% | — | — | |
| Q2 2015 | -2.8% | — | — | |
| Q1 2015 | -0.4% | — | — | |
| Q1 2014 | -0.4% | — | — | |
| Q4 2014 | -5.2% | — | — | |
| Q3 2013 | -5.5% | — | — | |
| Q3 2014 | -5.5% | — | — | |
| Q2 2013 | -1.3% | — | — | |
| Q2 2014 | -5.2% | — | — | |
| Q4 2013 | — | — | — | |
| Q1 2013 | — | — | — |
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