BeiGene, Ltd. (NASDAQ: BGNE, HKG: 6160, SHA: 688235) has released financial results for the Q4 and full-year 2022 periods, along with recent business highlights and upcoming milestones. Revenues reached USD 380.1 million in Q4, up 72.3%, and USD 1.4 billion for the full 12 months, up 97.9%. CEO John Oyler described the performance as “outstanding.”
Product Sales Performance
Product sales made up the majority of revenues at USD 339 million and USD 1.3 billion for Q4 and 2022, respectively. These were driven by the Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib) and the programmed death-1 (PD-1) inhibitor tislelizumab. Brukinsa sales reached USD 176.1 million in Q4, up 101%, and USD 564.7 million for the full year, up 159% YOY. This followed new indication approvals in the US for relapsed/refractory (R/R) and first-line chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), and in the EU to treat CLL. US sales of Brukinsa were particularly strong, up 237% YOY over the 12 months. In China, Brukinsa sales totaled USD 40.9 million and USD 150.3 million for Q4 and full year 2022, with respective growth of 33% and 49%.
Tislelizumab Sales and Market Expansion
Sales of tislelizumab in China totaled USD 102.2 million and USD 422.9 million over Q4 and 2022, with growth of 88% and 66% respectively. This reflected ongoing rising patient demand from broader reimbursement and further expansion of BeiGene’s salesforce and hospital listings.
Collaboration and In-Licensed Products
Sales of Amgen in-licensed products in China were USD 27.7 million and USD 114.6 million over Q4 and 2022, while sales of BMS in-licensed products in China totaled USD 21.4 million and USD 94.3 million, respectively. Collaboration revenue totaled USD 41.1 million and USD 161.3 million over the two periods, resulting from the partial recognition of upfront payments from Novartis related to tislelizumab and the TIGIT inhibitor ociperlimab.
Regulatory Approvals and Clinical Development
Brukinsa now has 34 regulatory approvals in 20 countries, while tislelizumab obtained a tenth indication approval in China during the period, with an eleventh currently under review at the NMPA. The PD-1 inhibitor is expected to gain its first overseas approvals imminently, awaiting decisions in Brazil, and with clinical studies underway in 31 countries around the globe. In addition, clinical development for ociperlimab (BGB-A1217), an investigational anti-TIGIT monoclonal antibody (mAb) with competent Fc function, BGB-11417, an investigational highly selective and highly potent inhibitor of BCL-2, and OX40 mAb BGB-A445, among others, are making progress.
Strategic Implications
The strong performance of BeiGene’s key products, Brukinsa and tislelizumab, highlights the company’s growth potential and market expansion strategies. With multiple regulatory approvals and ongoing clinical studies, BeiGene is well-positioned to continue its momentum in the global market, offering new treatment options for patients with various cancers.-Fineline Info & Tech
