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Sep 30, 2022
BeiGene Q3 2022 Earnings Report
BeiGene reported strong product revenue growth driven by BRUKINSA and tislelizumab.
Key Takeaways
BeiGene reported a strong third quarter with product revenue increasing by 82% year-over-year. BRUKINSA and tislelizumab were key growth drivers. The company's total product revenue this year has exceeded $1 billion.
Product revenue increased 82% year-over-year to $349.5 million.
BRUKINSA product revenue increased 136% globally.
Tislelizumab revenue in China increased 67% year-over-year.
BRUKINSA achieved superior Progression-Free Survival vs. IMBRUVICA in final analysis of Phase 3 ALPINE trial
BeiGene
BeiGene
BeiGene Revenue by Segment
Revenue by Segment
Brukinsa Revenue
CapyFin.com Forward Guidance
The company expects to continue supporting regulatory reviews for BRUKINSA and tislelizumab. They also anticipate presenting final analysis data for the global Phase 3 ALPINE trial and key data from BRUKINSA clinical development programs at upcoming medical congresses.
Positive Outlook
- Continue to support ongoing FDA review of the sNDA for CLL/small lymphocytic lymphoma, which has a PDUFA target action date of January 2023
- Continue to support the European Medicines Agency (EMA) and European Commission for the approval of new indication applications for CLL
- Continue to support Health Canada review of sNDA for CLL
- Continue to support NMPA review of sNDA for 1L CLL/SLL in China
- Continue to support the review of MHRA and Swissmedic for new indication application for MZL and CLL
Challenges Ahead
- We expect that the worldwide health crisis of COVID-19 will continue to have a negative impact on our operations, including commercial sales, regulatory interactions, inspections, filings, manufacturing, and clinical trial recruitment, participation, and data readouts.
- There remains uncertainty regarding the future impact of the pandemic both globally and specifically in China due to outbreaks and restrictions and potential impact on clinical, manufacturing and commercial operations.
- Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene's ability to demonstrate the efficacy and safety of its drug candidates
- The clinical results for its drug candidates, which may not support further development or marketing approval
- Actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval