BeiGene (06160) provides financial guidance for the first time: It is expected to achieve positive operating profit in 2025.

In the evening of February 27th, BEIGENE (ONC.US; 06160; 688235.SH) released its financial performance for the fourth quarter and full year of 2024, along with the announcement of A-share performance. The financial report shows that BEIGENE continued to demonstrate strong growth momentum in the global market in 2024, with total revenue reaching $3.8 billion, a 55% increase year-on-year. Product revenue became the main driving force behind the revenue growth. While experiencing rapid revenue growth, BEIGENE also achieved significant cost control and operational efficiency, marking a key turning point in global development. During the reporting period, BEIGENE significantly narrowed its operating losses, and excluding the impacts of non-cash items such as share-based payment expenses, depreciation, and amortization expenses, achieved a positive full-year non-GAAP operating profit. It is worth mentioning that BEIGENE provided financial guidance for the first time, with a total revenue guidance for the full year of 2025 of $4.9 billion to $5.3 billion, including expectations of strong revenue growth, benefiting from the leading position of Brukinsa in the United States and its continued expansion in Europe and other major global markets. At the same time, the company reiterated its expectation of positive GAAP operating profit and positive cash flow from operations. Core self-developed products saw a significant increase in sales, with global sales of Zanubrutinib exceeding $2 billion In 2024, BEIGENE achieved another record high in global product revenue, reaching $3.8 billion, compared to $2.2 billion in the same period last year, mainly driven by the growth in sales of Brukinsa (Zanubrutinib). Throughout the reporting period, Zanubrutinib continued to grow rapidly in global markets, with total global sales reaching $2.6 billion in 2024, a huge increase of 105% year-on-year. In the global biopharmaceutical field, drugs with annual revenue exceeding $1 billion are usually referred to as "blockbuster" drugs. The emergence of a "blockbuster" drug not only signifies a milestone commercial achievement for a company, but also proves the transformative potential of the drug. As a "best-in-class" BTK inhibitor, Zanubrutinib achieved global sales of $1.3 billion in 2023, officially entering the ranks of "blockbuster" drugs. In just one year, Zanubrutinib once again broke records, with annual sales exceeding $2 billion in 2024. Behind the continuous breaking of sales records by Zanubrutinib, it not only fully proves its own strong product strength, but also confirms the company's strong execution capabilities in global research and commercialization. Looking closely at the sales data of Zanubrutinib, the performance in the U.S. market was particularly outstanding, with annual sales reaching $2 billion, a 106% year-on-year increase. The financial report shows that Zanubrutinib has been approved in over 70 markets globally, and is currently the leader in the treatment of new patients with CLL and all other approved indications in the United States, with a continuously increasing market share. At the same time, Zanubrutinib has also achieved impressive sales performance in other key markets. Sales in Europe gradually increased, with annual sales reaching $359 million, a 194% year-on-year increase, primarily due to the increase in market share of the product in all major markets, including Germany, Italy, Spain, France, and the United Kingdom. In recent years, the competition in the BTK inhibitor field has been fierce, with second-generation BTK inhibitors continuously capturing market share. Looking at quarterly performance, according to U.S. announcements, Zanubrutinib's global sales in the fourth quarter were $828 million, a 100% year-on-year increase. In comparison, the sales of acalabrutinib in the fourth quarter of 2024 were $808 million, with total annual sales of $3.129 billion, a 24% year-on-year increase. Therefore, this quarter Zanubrutinib's global sales exceeded acalabrutinib's for the first time. Another core self-developed product of BEIGENE, the PD-1 antibody tislelizumab (telirizumab), saw steady sales growth, with annual sales reaching $621 million in 2024, a 16% year-on-year increase, primarily benefiting from the expansion of reimbursement coverage in the medical insurance catalog and an increase in the number of drug admissions. In China, telirizumab has been approved for the treatment of 14 indications, of which 13 indications that meet the inclusion criteria have been included in the national medical insurance catalog. On the global front, telirizumab is continuously advancing its global commercialization process, with approvals in 45 markets for multiple indications, with over 1.3 million patients receiving treatment. Fully promoting the development of self-developed pipeline products By developing competitive products such as Zanubrutinib and telirizumab, BEIGENE has completed a critical pipeline transformation in the past few years: in the field of hematology, in addition to Zanubrutinib, the potential best-in-class BCL2 inhibitor sonrotoclax and the BTK degrader BGB-16673 have entered into registration clinical trials, demonstrating differentiated potential. Among them, sonrotoclax has the potential to be the best in its class, with multiple clinical trials currently ongoing, involving more than 1,800 patients. Among them, a Phase 2 trial for R/R MCL is expected to read out data in the second half of this year, with the hope of submitting potential accelerated approval applications based on these two indications. In addition, the global Phase 3 clinical trial for the first-line treatment of CLL with a combination of sonrotoclax and Zanubrutinib has completed enrollment. BGB-16673, a BTK degrader, is currently the fastest progressing BTK degrader in clinical development, developed by the BEIGENE research platform CDAC. So far, the clinical project has enrolled more than 500 patients, showing promising preliminary clinical data. It is expected to initiate two global Phase 3 trials this year, including a head-to-head comparison with a non-covalent BTK inhibitor pirtobrutinib for the treatment of R/R CLL. At the same time, in the field of solid tumors, BEIGENE's product portfolio has expanded from focusing on tumor immunotherapy to a diverse pipeline, accelerating its layout in the treatment of lung cancer, breast cancer, gynecological cancer, and gastrointestinal cancers, and gathering diverse technology platforms, including differentiated antibody-drug conjugates, multi-specific antibodies, targeted protein degraders, and small molecule inhibitors. The financial report shows that in the fourth quarter of 2024, BEIGENE pushed forward six new molecular entities into clinical trials with the advantage of "rapid concept validation".Bed, a total of 13 new molecular entities were advanced into clinical development stages throughout the year. It is expected that data readouts for BGB-43395 (CDK4 inhibitor), BG-68501 (CDK2 inhibitor), and BG-C9074 (B7H4 ADC) will be conducted in the first half of 2025; internal concept validation data for multiple projects, including: BG-60366 (EGFR CDAC), BGB-53038 (pan-KRAS inhibitor), BG-C137 (FGFR2b ADC), BGB-C354 (B7H3 ADC), and BG-C477 (CEA ADC), are expected to be obtained in the second half of 2025."Bonjour tout le monde" "Hello everyone"