BeiGene Q4 2019 Earnings Report
Key Takeaways
BeiGene reported a Q4 2019 revenue of $56.89 million, primarily from product sales. The quarter saw increased R&D and SG&A expenses, leading to a net loss of $388.06 million. The company highlighted key approvals and collaborations, while also acknowledging potential COVID-19 impacts.
BRUKINSA received accelerated approval from the U.S. FDA and was launched as a treatment for mantle cell lymphoma.
Tislelizumab was approved in China for classical Hodgkin’s lymphoma.
Total revenue for the quarter was $56.89 million, with product revenues of $56.89 million.
Strategic collaboration with Amgen was closed to commercialize oncology products in China and jointly develop pipeline assets.
BeiGene
BeiGene
BeiGene Revenue by Segment
Forward Guidance
BeiGene anticipates potential COVID-19 impacts on its operations in China, including commercial sales and clinical trials. The company is working to minimize disruptions and continues to execute on its commercialization, regulatory and clinical development goals in China.
Positive Outlook
- Receive approvals in China for the treatment of patients with R/R MCL and R/R CLL/SLL in the first half of 2020.
- Announce top-line results from the SEQUOIA trial comparing zanubrutinib with bendamustine plus rituximab in patients with TN CLL or SLL as early as the second half of 2020.
- File an sNDA in China for WM in 2020.
- Discuss ASPEN data with U.S. FDA and European Medicines Agency (EMA) and present Phase 3 ASPEN data at a major medical conference in 2020.
- Complete expanded enrollment in the Phase 3 ALPINE trial comparing zanubrutinib with ibrutinib in patients with R/R CLL/SLL in 2020.
Challenges Ahead
- The Company expects that the worldwide health crisis of COVID-19 will have a negative impact on its operations in China, including commercial sales, regulatory interactions and inspections, and clinical trial recruitment and participation, particularly in the first quarter and possibly longer depending on the scope and duration of the disruption.
- If BeiGene cannot demonstrate the efficacy and safety of its drug candidates, actual results may differ materially from those indicated in the forward-looking statements.
- Actions of regulatory agencies may affect the initiation, timing and progress of clinical trials and marketing approval
- BeiGene's ability to achieve commercial success for its marketed products and drug candidates, if approved, is uncertain.
- BeiGene's reliance on third parties to conduct drug development, manufacturing and other services could be a risk.
Revenue & Expenses
Visualization of income flow from segment revenue to net income