BeiGene Q3 2021 Earnings Report
Key Takeaways
BeiGene reported a strong third quarter with a 111% increase in product revenue compared to the prior year period. The company saw significant growth in sales of BRUKINSA and tislelizumab, along with the launch of a new product from the Amgen collaboration. BeiGene also achieved important regulatory milestones, including the FDA acceptance of the BLA for tislelizumab and approvals for BRUKINSA in new indications and markets.
Product revenue increased by 111% year-over-year to $192.5 million, driven by internally developed products and in-licensed products from Amgen.
Global sales of BRUKINSA rose by 320% to $65.8 million, with significant contributions from both U.S. and China markets.
Tislelizumab sales in China increased by 54% to $77.0 million, fueled by new patient demand and market share expansion.
The company's first biologics license application (BLA) in the U.S. for tislelizumab was accepted for review by the FDA.
BeiGene
BeiGene
BeiGene Revenue by Segment
Forward Guidance
BeiGene anticipates several milestones in the near term, including regulatory approvals and clinical trial results.
Positive Outlook
- Expected EMA approval for BRUKINSA in treating adult patients with WM in 2021.
- Reporting results from the Phase 3 SEQUOIA trial comparing BRUKINSA with bendamustine plus rituximab in patients with treatment-naïve CLL or SLL.
- Continue to discuss Phase 3 clinical trial results in CLL with regulatory agencies in the U.S., Europe, and other countries.
- Report additional results from the Phase 3 ALPINE trial in 2022.
- Receive approvals in China for the four sBLAs currently under review in first-line NPC, second- or third-line NSCLC, second-line ESCC, and second- or third-line MSI-High solid tumors in 2022.
Challenges Ahead
- The Company expects that the worldwide health crisis of COVID-19 will continue to have a negative impact on its operations, including commercial sales, regulatory interactions, inspections, filings, and clinical trial recruitment, participation, and data read outs.
- Uncertainty regarding the future impact of the pandemic globally.
- BeiGene contests BMS-Celgene's termination of a license and supply agreement with respect to ABRAXANE® in China.
- Arbitration proceedings are ongoing between the parties regarding BMS-Celgene’s failure to ensure the continuity and adequacy of its supply of ABRAXANE under the agreement in accordance with Good Manufacturing Practices (GMP).
- Phase 2 trial evaluating investigational SARS-CoV-2 neutralizing antibody BGB-DXP593 in patients with mild to moderate COVID-19 did not meet the primary efficacy endpoint.