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Mar 31, 2021
Kiniksa Q1 2021 Earnings Report
Reported first quarter 2021 financial results and recent corporate and portfolio activity.
Key Takeaways
Kiniksa reported first quarter results, highlighting the FDA approval of ARCALYST for recurrent pericarditis and progress in their broader portfolio of immune-modulating assets, including mavrilimumab and KPL-404.
ARCALYST launched as the first and only FDA-approved therapy for recurrent pericarditis.
Mavrilimumab Phase 2 data in severe COVID-19 demonstrated a reduction in mechanical ventilation and death at Day 29; Phase 3 enrollment ongoing.
Final KPL-404 Phase 1 data support further development in patients; Phase 2 proof-of-concept trial initiation planned for 2H 2021.
Cash reserves of approximately $264 million.
Forward Guidance
Kiniksa is focused on the launch of ARCALYST and are confident in their commercialization strategy.
Positive Outlook
- Engaging with the FDA and other government agencies to identify pathways for the potential accelerated availability of mavrilimumab as a therapeutic option for severe COVID-19 patients.
- Initiating Phase 2 proof-of-concept trial of KPL-404 in rheumatoid arthritis in the second half of 2021.
- KPL-404 has the potential to address a broad range of autoimmune diseases.
- Vixarelimab is the only monoclonal antibody in development that targets both interleukin-31 (IL-31) and oncostatin M (OSM) pathways simultaneously.
- Expectation about cash reserves funding current operating plan into 2023.
Challenges Ahead
- Delays or difficulty in enrollment of patients in, and activation or continuation of sites for, clinical trials.
- Amendments to clinical trial protocols initiated or required by regulatory authorities.
- Delays or difficulty in completing clinical trials, including as a result of the COVID-19 pandemic.
Historical Earnings Impact
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Avg. Return Before/After Earnings
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