10-QPeriod: Q3 FY2021

BeOne Medicines Ltd. Quarterly Report for Q3 Ended Sep 30, 2021

Filed November 4, 2021For Securities:ONCBEIGF

Summary

BeiGene, Ltd. (BeiGene) reported robust revenue growth in the third quarter of 2021, driven by strong performance of its internally developed products, BRUKINSA® and tislelizumab, as well as in-licensed products. Total revenue surged by 126.7% year-over-year to $206.4 million. Product revenue, in particular, more than doubled to $192.5 million, fueled by significant increases in BRUKINSA® sales in the U.S. and China, and continued strong sales of tislelizumab in China. The company also saw positive contributions from newly launched products like pamiparib and Amgen's XGEVA® and BLINCYTO® in China. Despite the impressive revenue growth, BeiGene reported a net loss of $413.9 million for the quarter. This was primarily driven by substantial investments in research and development, which increased slightly year-over-year to $351.9 million, and a significant rise in selling, general, and administrative expenses, up 67.4% to $269.2 million, reflecting the expansion of its global commercial and R&D organizations. The company ended the quarter with a strong cash position of approximately $1.39 billion in cash, cash equivalents, and restricted cash, supported by a substantial $2.5 billion in short-term investments.

Financial Statements
Beta

Key Highlights

  • 1Total revenue for Q3 2021 increased by 126.7% to $206.4 million compared to $91.1 million in Q3 2020.
  • 2Product revenue grew by 111.3% to $192.5 million, driven by strong sales of BRUKINSA® and tislelizumab.
  • 3BRUKINSA® global sales reached $65.8 million, a 320% increase year-over-year, with significant growth in both the U.S. and China.
  • 4Tislelizumab sales in China increased by 54% to $77.0 million, benefiting from broader reimbursement and salesforce expansion.
  • 5Research and Development expenses remained high at $351.9 million, a slight increase of 0.8% year-over-year.
  • 6Selling, General, and Administrative expenses increased significantly by 67.4% to $269.2 million, reflecting global expansion.
  • 7The company maintained a strong liquidity position with $1.39 billion in cash, cash equivalents, and restricted cash as of September 30, 2021.

Frequently Asked Questions

BeiGene's revenue surged in Q3 2021 primarily due to strong sales growth from its internally developed products, BRUKINSA® and tislelizumab. BRUKINSA® saw a remarkable 320% increase in global sales, driven by strong uptake in the U.S. and China. Tislelizumab sales in China also grew by 54%. The company also benefited from the sales of newly launched products like pamiparib and in-licensed products from Amgen.

Despite significant revenue growth, BeiGene reported a net loss of $413.9 million in Q3 2021. This was primarily due to continued substantial investments in research and development, which were $351.9 million for the quarter, and a significant increase in selling, general, and administrative expenses to $269.2 million. These increased expenses reflect the company's ongoing investment in expanding its global commercial operations, R&D capabilities, and clinical pipeline.

BeiGene maintained a strong liquidity position as of September 30, 2021, with approximately $1.39 billion in cash, cash equivalents, and restricted cash. Additionally, the company held $2.53 billion in short-term investments, providing ample financial resources to fund its ongoing operations and development activities.

Both BRUKINSA® and tislelizumab are performing strongly. BRUKINSA® saw significant year-over-year sales growth across all key markets, including the U.S. and China, with recent FDA approvals in Waldenström’s macroglobulinemia and marginal zone lymphoma contributing to this growth. Tislelizumab sales in China also showed robust growth, driven by broader reimbursement and expansion of the salesforce. BeiGene is also preparing for upcoming NRDL negotiations in China for these products, which is expected to impact pricing but potentially increase market penetration.