BEIGENE (06160) Q3 revenue exceeded $1 billion for the first time, achieving non-GAAP operating profit for two consecutive quarters.

On the evening of November 12th, BEIGENE (06160) released the 2024 third quarter financial report for its American stock and the main financial data announcement for its A shares. In the third quarter, BEIGENE continued its strong growth momentum, achieving a revenue of 7.139 billion yuan, an increase of 26.9% year-on-year. Global product revenue reached 7.079 billion yuan, an increase of 65.1% year-on-year. For the first three quarters of 2024, BEIGENE's total operating income reached 19.136 billion yuan, an increase of 48.6% year-on-year. Product sales continued to grow rapidly, with product revenue for the first three quarters reaching 18.986 billion yuan, an increase of 72.9% year-on-year. Both total revenue and product revenue for the first three quarters exceeded the full year revenue of 17.423 billion yuan last year, demonstrating a remarkable performance. According to the American stock financial report, BEIGENE's financial situation continued to improve, with total revenue reaching 1.002 billion US dollars this quarter, achieving a quarterly revenue of 1 billion US dollars for the first time. Under the Generally Accepted Accounting Principles (GAAP), BEIGENE's operating loss decreased by 10% year-on-year. In addition, after adjusting for non-cash items such as share-based payments, depreciation, and amortization expenses, adjusted operating profit reached 66 million US dollars. As a result, BEIGENE has now recorded two consecutive quarters of non-GAAP operating profit. It is worth noting that, with significantly increased product revenue and cost management, BEIGENE further improved its operational efficiency and continued to reduce its net loss. According to the financial report, the net profit for the same period last year mainly benefited from non-operating income of 363 million US dollars (before and after tax) generated from the arbitration settlement with BMS and the recognition of deferred income from the remaining Novartis cooperation agreement. BEIGENE co-founder, Chairman, and CEO, Mr. John V. Oyler, stated, "The outstanding performance in the third quarter further demonstrates the company's leadership position in the global oncology field, thanks to our unique research and clinical advantages, as well as the strong momentum of Brukinsa. In the United States, Brukinsa as the most widely indicated BTK inhibitor has now become the leader in the treatment of frontline and relapsed/refractory CLL, as well as in all other approved B-cell malignancies for new patients. As the cornerstone of the company's hematology pipeline, Brukinsa demonstrates significant clinical treatment potential, whether as a monotherapy or in combination with late-stage pipeline BCL2 inhibitor sonrotoclax and BTK degrader BGB-16673 as the best combination therapy in its class. In the solid tumor field, we are expanding access to the PD-1 inhibitor Tislelizumab among global patients, building and continually deepening our global commercialization capabilities to advance numerous exciting potential anticancer treatments. Additionally, through three core platform technologies of bispecific antibodies, protein degraders, and antibody-drug conjugates, we are laying the foundation for expanding into the areas of breast cancer, lung cancer, and gastrointestinal cancer in the future. This progress not only demonstrates our achievements but also confirms our commitment to positively impacting the lives of global patients, bringing hope and progress in the fight against cancer." Brukinsa achieves global revenue of nearly 5 billion yuan, strengthening leadership in hematology In 2023, the BTK inhibitor Brukinsa (Zanubrutinib) surpassed the billion-dollar mark in annual revenue for the first time, marking an important milestone in BEIGENE's commercial achievements. In the first half of 2024, Brukinsa once again broke through, achieving over 1.1 billion US dollars in revenue. The American stock financial report shows that Brukinsa has already generated sales of over 1.8 billion US dollars in the first three quarters of this year, demonstrating strong growth momentum. According to the main financial data announcement for the A shares, in the third quarter of 2024, Brukinsa achieved global sales of 4.914 billion yuan, a year-on-year increase of 91.1%, further consolidating its leadership position in the field of hematology. By region, Brukinsa sales in the United States reached 3.584 billion yuan, an 85% year-on-year increase, with over 60% of the quarter-on-quarter demand growth coming from expanded use in the indication of chronic lymphocytic leukemia (CLL), while the market share of the product continues to increase in CLL among new patients. In Europe, total sales amounted to 693 million yuan, a 212.7% year-on-year increase. In China, sales reached 485 million yuan, a 41.1% year-on-year increase. The company maintains a leading position in the BTK inhibitor market in China. Currently, Brukinsa has received multiple indications in over 70 markets worldwide and is the only BTK inhibitor that has demonstrated superior efficacy results compared to Ibrutinib in head-to-head trials. In the field of hematology, based on the success of Brukinsa, BEIGENE is rapidly advancing key late-stage pipeline projects, including sonrotoclax, BGB-16673, etc. Among them, the BCL-2 inhibitor sonrotoclax, as a novel, structurally optimized BCL2 inhibitor, is currently in phase 3 clinical trials with over 1,300 patients enrolled, showing potential as the "best in class." Historically, the BCL-2 track had only one product, Venetoclax, approved and on the market, while sonrotoclax is progressing well and has the potential to break Venetoclax's monopoly. In 2023, a phase 3 trial of sonrotoclax + Zanubrutinib challenging Venetoclax + Obinutuzumab in the frontline CLL, a key indication, was initiated. Furthermore, leveraging the expertise in developing BTK inhibitors and understanding unmet clinical needs, BEIGENE is delving into the development of BTK CDAC (Chimeric Degrading Activated Compound) BGB-16673, which is currently in phase 2 clinical trials with over 350 patients enrolled. The American stock financial report indicates that a phase 3 clinical trial for the treatment of R/R CLL with BGB-16673 is expected to start in the first half of 2025. As of October 2024, the Pharma Cube database shows that only 6 BTK degraders have entered clinical stages globally, with BGB-16673 leading the progress. From Zanubrutinib to sonrotoclax, and now to BGB-16673, BEIGENE's research pipeline continues to advance.Continuously consolidating its leading position in the field of blood tumor diseases by expanding from point to line and deepening the layout.PD-1 further expands the global map, and solid tumor scale innovation In the third quarter of 2024, BEIGENE's core self-developed product PD-1 antibody tislelizumab (BaiZeAn) achieved sales of 1.169 billion RMB, a year-on-year increase of 11.7%. In China, BaiZeAn continues to gain a leading market share, with 14 approved indications and 11 included in the national medical insurance list. While maintaining steady sales growth, BaiZeAn further expanded its global business scope this quarter, deepening its global commercialization capabilities. To date, tislelizumab has been approved in 42 countries and regions, including China, the United States, the European Union, the United Kingdom, Brazil, and Singapore, benefiting more than 1.3 million patients. In October 2024, BaiZeAn was officially launched for commercialization in the United States, with the first prescription issued for the second-line treatment of esophageal squamous cell carcinoma (ESCC) in adult patients. The process from approval to commercialized clinical treatment only took 8 months, marking a new chapter for BEIGENE's proprietary solid tumor commercialization team in the United States. In the European Union, BaiZeAn has also been commercially launched in some European countries for the second-line treatment of ESCC patients and the first and second-line treatment of non-small cell lung cancer (NSCLC) patients. In the field of solid tumor treatment, in addition to expanding the global accessibility of BaiZeAn, BEIGENE is advancing a series of differentiated product pipelines, with drug forms including small molecules, monoclonal antibodies, bispecific/multispecific antibodies, ADCs, CDACs, etc., and strategically covering the most common and largest market-capacity cancer types such as lung cancer, breast cancer, and gastrointestinal tumors. This quarter, BEIGENE has pushed forward 4 new molecular entities into the clinical development stage, bringing the total to 8 this year, with expectations to achieve over 10 new molecular entities entering clinical trials by the end of the year. Regarding research and development strategy and layout, BEIGENE stated that the company's product portfolio strategy emphasizes rapid generation of early clinical concept validation data, benefiting from its global clinical operational model with speed and cost advantages ("rapid concept validation"). Currently, BEIGENE's internal clinical operations team consists of 3,600 people conducting trials on five continents, collaborating with regulatory agencies and researchers from over 45 countries to ensure data quality meets strict standards. BEIGENE stated that this strategic model, data-driven, focuses investments on the most promising and clinically differentiated candidate projects, lowering the priority of other projects to maximize resource utilization. Currently, BEIGENE has one of the largest oncology research teams in the industry, with strong capabilities in small molecule and antibody drug discovery, including three platform technologies: multispecific antibodies, chimeric degradative activators (CDACs), and antibody-drug conjugates (ADCs). In the third quarter of 2024, BEIGENE continued to deepen its global commercialization capabilities, achieving a new high in quarterly revenue. While accelerating the scaling of products, BEIGENE continues to drive research and development processes, optimize operational efficiency, and accumulate strength for long-term development.