BeiGene (NASDAQ: BGNE), a China-based biopharmaceutical company, has presented its financial results for the fourth quarter and full year of 2023, along with key business highlights. The company reported continued rapid global growth, with record total revenues reaching USD 634 million in the fourth quarter and USD 2.5 billion for the full year, marking increases of 67% and 74% from the previous year’s periods, respectively. Product revenues for the quarter were USD 630.5 million, and for the full year, they were USD 2.2 billion, showing increases of 86% and 75% from the prior-year totals.
The growth was primarily driven by core products, including the Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib) and the programmed death-1 (PD-1) inhibitor tislelizumab. Brukinsa generated USD 413 million in the fourth quarter and USD 1.29 billion for the full year, up 134.5% and 128.5%, respectively, becoming the first home-grown drug to achieve the USD 1 billion sales mark. The European Commission approved Brukinsa for the treatment of adult patients with R/R follicular lymphoma (FL), making it the first BTK inhibitor approved in this indication and the one with the broadest label in its class. Tislelizumab brought in USD 128 million (+25.2%) and USD 536.6 million (+26.9%) for the fourth quarter and full year, respectively, with approvals in China for first-line hepatocellular carcinoma (HCC) and in the UK for second-line advanced esophageal squamous cell carcinoma (ESCC) in 2023. Additionally, products licensed from Amgen contributed USD 51.1 million (+84.5%) and USD 188.3 million (+64.3%) in sales for the fourth quarter and full year, respectively.
The U.S. remained the largest market for BeiGene, with revenues of USD 313.2 million and USD 1.1 billion for the fourth quarter and full year, compared to USD 155.4 million and USD 502.6 million in the prior-year periods. The company anticipates this trend to persist in 2024, with growing U.S. sales of Brukinsa.
GAAP net loss improved for the fourth quarter and full year of 2023 compared to the prior-year periods, mainly due to reduced operating losses and a non-operating gain of USD 362.9 million related to the BMS arbitration settlement for the full year 2023. Cash used in operations for the fourth quarter and full year 2023 was USD 221.6 million and USD 1.2 billion, respectively, compared to USD 318.2 million and USD 1.5 billion in the prior-year periods, driven by improved operating leverage.
BeiGene advanced five new molecular entities (NMEs) into clinical trials in 2023, including the potential best-in-class CDK4 inhibitor BGB-43395. Additionally, four registrational trials for sonrotoclax were initiated, including a global Phase III study in treatment-naïve chronic lymphocytic leukemia (CLL). The BTK CDAC BGB-16673 started two global cohort expansion studies in recurrent or refractory (R/R) CLL and R/R mantle cell lymphoma (MCL).- Flcube.com