Loading...
•
Mar 31, 2023
BeiGene Q1 2023 Earnings Report
BeiGene reported first quarter results with significant revenue growth and progress in clinical development programs.
Key Takeaways
BeiGene's first quarter 2023 results showed strong product revenue growth of 56.9% year-over-year, driven by BRUKINSA and tislelizumab. The company is focused on operational excellence and financial discipline to bring affordable medicines to patients globally.
Product revenue increased by 56.9% compared to the prior-year period, reaching $410.3 million.
Global BRUKINSA product revenue more than doubled from the first quarter of 2022, totaling $211.4 million.
Tislelizumab sales in China grew by 31% compared to the prior-year period, reaching $114.9 million.
The company continues to advance its pipeline of innovative therapies for cancer patients.
BeiGene
BeiGene
BeiGene Revenue by Segment
Revenue by Segment
Brukinsa Revenue
CapyFin.com Forward Guidance
BeiGene provided updates on expected milestones for BRUKINSA, tislelizumab, BGB-11417, ociperlimab, BGB-16673, BGB-A445, and BGB-15025, as well as collaboration programs.
Positive Outlook
- Continue to support U.S. FDA and European Medicines Agency (EMA) review of sNDA for PFS superiority in R/R CLL
- Continue to support National Medical Products Administration review of sNDA for first-line CLL/SLL and WM in China, with a decision expected in the first half of 2023
- Continue to support Health Canada review of sNDA for CLL, with decision expected in 2023
- Continue to support NMPA review of BLA applications for tislelizumab in combination with chemotherapy as a first-line treatment in patients with unresectable locally advanced, recurrent or metastatic ESCC, with a decision expected in the first half of 2023; and for tislelizumab as a treatment for first-line hepatocellular carcinoma, with a decision expected in the second half of 2023
- Initiate global pivotal trial in first-line CLL in combination with BRUKINSA in the second half of 2023
Challenges Ahead
- The COVID-19 pandemic continues to have a negative impact on our operations, including commercial sales, regulatory interactions, inspections, filings, manufacturing, and clinical trial recruitment, participation, and data readouts.
- Actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval
- BeiGene's ability to achieve commercial success for its marketed medicines and drug candidates, if approved
- BeiGene's ability to obtain and maintain protection of intellectual property for its medicines and technology
- BeiGene’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its ability to obtain additional funding for operations and to complete the development of its drug candidates and achieve and maintain profitability