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Jun 30, 2022
BeiGene Q2 2022 Earnings Report
BeiGene reported a strong Q2 2022 with increased product revenue and progress in clinical development programs.
Key Takeaways
BeiGene reported a 120% increase in product revenue for Q2 2022, driven by BRUKINSA and tislelizumab. The company is progressing with regulatory filings and clinical trials for its key drug candidates. With a strong capital position, BeiGene is focused on expanding its commercial portfolio and advancing its R&D programs.
Product revenue increased by 120% compared to the prior year period.
BRUKINSA global revenue increased by 203% year-over-year.
Tislelizumab sales in China increased by 40% compared to the prior year period.
The company continues to advance its pipeline with regulatory submissions and clinical trial milestones.
BeiGene
BeiGene
BeiGene Revenue by Segment
Revenue by Segment
Brukinsa Revenue
CapyFin.com Forward Guidance
BeiGene anticipates several milestones in the near future, including regulatory reviews and clinical data announcements for BRUKINSA and tislelizumab. The company is also focused on expanding its manufacturing capabilities and advancing its early-stage programs.
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.
- Announce final analysis data for the global Phase 3 ALPINE trial including progression-free survival in 2022.
- Announce topline results from the global Phase 3 clinical trial of tislelizumab as a 1L treatment for patients with HCC in Q3 2022.
- Initiate additional pivotal clinical trials for Ociperlimab in 2022.
- Present Phase 1 clinical data for non-Hodgkin's lymphoma, CLL, AML and multiple myeloma at a medical congress in late 2022.
Challenges Ahead
- The FDA cited only the inability to complete inspections due to restrictions on travel as the reason for the deferral and did not provide a new anticipated action date as they continue to monitor the public health situation and travel restrictions.
- 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.
- Actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval.