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Dec 31, 2020
Kiniksa Q4 2020 Earnings Report
Kiniksa reported fourth quarter and full-year 2020 financial results and corporate and pipeline activity.
Key Takeaways
Kiniksa reported strong performance in 2020, driven by encouraging clinical data across its pipeline and regulatory designations for rilonacept, mavrilimumab, and vixarelimab. The company anticipates launching rilonacept in recurrent pericarditis in the first half of 2021, pending FDA approval, and expects data from clinical trials for KPL-404 and mavrilimumab in severe COVID-19 in the same period. With cash reserves of approximately $323 million, Kiniksa is well-capitalized.
Rilonacept in recurrent pericarditis granted priority review, with PDUFA goal date of March 21, 2021.
Clinical data expected in 1H 2021 from KPL-404 (anti-CD40) Phase 1 clinical trial.
Clinical data expected in 1H 2021 from mavrilimumab Phase 2 clinical trial in severe COVID-19.
Year-end 2020 cash reserves of approximately $323 million.
Forward Guidance
Kiniksa anticipates several milestones in the first half of 2021, including the potential launch of rilonacept, final Phase 1 data for KPL-404, and data from the mavrilimumab Phase 2 clinical trial.
Positive Outlook
- Potential commercial launch of rilonacept in recurrent pericarditis in the first half of the year, if approved by the FDA.
- Plans to commence sales and distribution of rilonacept for all other approved indications in the United States at that time.
- Expected data from the Phase 2 portion of the Phase 2/3 clinical trial of mavrilimumab in severe COVID-19 pneumonia and hyperinflammation in the first half of 2021.
- Final data and safety follow-up from all cohorts of the single-ascending-dose Phase 1 clinical trial of KPL-404 in healthy volunteers in the first half of 2021.
- 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 by the company or required by regulatory authorities.
Historical Earnings Impact
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