On the evening of November 12, BeiGene released its third quarter 2024 U.S. stock performance report and A-share main financial data announcement. In the third quarter, BeiGene continued its strong growth momentum, achieving revenue of 7.139 billion yuan, a year-on-year increase of 26.9%. Global product revenue reached 7.079 billion yuan, a year-on-year increase of 65.1%.

The overall performance is eye-catching

. In the first three quarters of 2024, BeiGene's total operating revenue reached 19.136 billion yuan, a year-on-year increase of 48.6%. Products continue to increase in volume at a high speed, with product revenue of 18.986 billion yuan in the first three quarters, a year-on-year increase of 72.9%. Whether it is total revenue or product revenue, the first three quarters have exceeded last year's full-year revenue of 17.423 billion yuan, and the performance is very eye-catching. According

to the U.S. stock financial report, BeiGene's financial situation continues to improve, with total revenue of US$1.002 billion this quarter, achieving a single-quarter revenue of more than US$1 billion for the first time. Under the U.S. Generally Accepted Accounting Principles (GAAP), BeiGene's operating loss fell by 10% year-on-year. In addition, after excluding the impact of non-cash items such as share-based payment expenses, depreciation and amortization expenses, the adjusted operating profit reached US$66 million. Since then, BeiGene has achieved non-GAAP operating profit for two consecutive quarters.

It is also worth mentioning that with the substantial growth in product revenue and expense management, BeiGene has further promoted the improvement of operating efficiency, and its net loss continued to improve month-on-month. According to the financial report, the net profit in the same period last year was mainly due to the non-operating income of US$363 million (before and after tax) generated by the arbitration settlement with BMS and the recognition of the remaining deferred income from the Novartis cooperation agreement.

Mr. John Oyler, co-founder, chairman and CEO of BeiGene V. Oyler, CEO of the Company, said: "The outstanding performance in the third quarter further demonstrates the company's leadership in global oncology treatment, thanks to our unique R&D and clinical advantages, as well as the strong market momentum of BYUZEL®. In the United States, BYUZEL®, as the BTK inhibitor with the broadest indications, has become a leader in the treatment of new patients in first-line and relapsed/refractory CLL, as well as all other approved B-cell malignancies. As the cornerstone of the company's hematology pipeline, BYUZEL® has demonstrated great clinical treatment potential, either as a monotherapy or in combination with the late-stage pipeline BCL2 inhibitor sonrotoclax and BTK degrader BGB-16673 as a best-in-class combination therapy. In the field of solid tumors, we are expanding the accessibility of the PD-1 inhibitor BeiGene® to patients around the world and building and continuously deepening our global commercialization capabilities to advance a number of exciting potential anti-cancer drugs. At the same time, we are laying the foundation for future expansion in breast cancer, lung cancer and gastrointestinal cancer through three core platform technologies: multi-specific antibodies, protein degraders and antibody-drug conjugates. This progress not only highlights our achievements, but also confirms our commitment to actively impact the lives of patients around the world and bring hope and progress to the fight against cancer. "

Zabutinib generates nearly 5 billion yuan in global revenue

. In 2023, the BTK inhibitor BeiGene® (Zabutinib) will exceed the billion-dollar mark for the first time in its annual revenue, marking an important milestone in BeiGene's commercialization achievements. In the first half of 2024, BeiGene® will break through again, achieving revenue of more than 1.1 billion US dollars. According to the US stock financial report, BeiGene®'s sales in the first three quarters of this year have exceeded 1.8 billion US dollars, and its growth performance is full of stamina.

According to the announcement of the main financial data of A-shares, in the third quarter of 2024, the global sales of Baiyueze® reached 4.914 billion yuan, a year-on-year increase of 91.1%, further consolidating its leading position in the field of hematology.

By region, the sales of Baiyueze® in the United States were 3.584 billion yuan, a year-on-year increase of 85%, of which more than 60% of the quarter-on-quarter demand growth came from the expansion of its use in chronic lymphocytic leukemia (CLL) indications, and the market share of the product in new CLL patients continued to increase. Sales in Europe totaled 693 million yuan, a year-on-year increase of 212.7%. Sales in China reached 485 million yuan, a year-on-year increase of 41.1%. The company's market share in the field of BTK inhibitors in China continues to maintain a leading position.

At present, Baiyueze® has been approved for multiple indications in more than 70 markets around the world, and it is also the only BTK inhibitor that has achieved superior efficacy results compared with ibrutinib in head-to-head trials.

In the field of hematology, based on the successful experience of Baiyueze®, BeiGene is rapidly advancing key projects in the late-stage pipeline, including sonrotoclax, BGB-16673, etc. Among them, the BCL-2 inhibitor sonrotoclax, as a new type of structurally optimized BCL2 inhibitor, is currently in the Phase 3 clinical stage, with more than 1,300 patients enrolled, and has the potential to be "best in class".

For a long time, only one product, venetoclax, has been approved for marketing in the BCL-2 track, and sonrotoclax is ahead in development, which is expected to break the situation of venetoclax being the only one. In 2023, the Phase 3 trial of sonrotoclax+zabutinib challenging venetoclax+otuzumab will be launched, aiming at the important indication field of first-line CLL.

In addition, using the expertise in the development of BTK inhibitors and the understanding of unmet clinical needs, BeiGene is deeply developing BTK CDAC (chimeric degradation activation compound) BGB-16673, which is currently in the Phase 2 clinical stage, with more than 350 patients enrolled. According to the US stock financial report, it is expected to launch a Phase 3 clinical trial of BGB-16673 for the treatment of R/R CLL in the first half of 2025.

As of October 2024, relevant data show that only six BTK degraders have entered the clinical stage worldwide, and BGB-16673 is currently ranked first. From zanubrutinib to sonrotoclax, and then to BGB-16673, BeiGene's R&D pipeline is being laid out from point to line, and continues to consolidate its leadership in the field of hematological tumor diseases.

PD-1 further expands its global footprint

In the third quarter of 2024, BeiGene's core self-developed product PD-1 antibody BeiGene® (tislelizumab) had sales of 1.169 billion yuan, a year-on-year increase of 11.7%. In China, BeiGene® continues to achieve a leading market share, has been approved by NMPA for 14 indications, and 11 indications have been included in the national medical insurance catalog.

While sales have grown steadily, this quarter BeiGene® further expanded its global business scope and deepened its global commercialization capabilities. So far, 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, BeiGene officially launched Tisgene® in the United States for commercialization and the first prescription was issued for the second-line treatment of adult patients with esophageal squamous cell carcinoma (ESCC). It took only 8 months from approval to commercial clinical treatment, marking a new chapter for BeiGene's own US solid tumor commercialization team. In the EU, Tisgene® has also been commercialized in some European countries for the second-line treatment of ESCC patients and the first-line and second-line treatment of patients with non-small cell lung cancer (NSCLC).

In the field of solid tumor treatment, in addition to expanding the global accessibility of Tisgene®, BeiGene is advancing a series of differentiated product pipelines, with drug forms ranging from small molecules, monoclonal antibodies, bispecific antibodies/multispecific antibodies, ADCs, CDACs, etc., while strategically covering the highest incidence and largest market capacity cancers such as lung cancer, breast cancer and gastrointestinal tumors. This quarter, BeiGene has promoted 4 new molecular entities into clinical development, a total of 8 so far this year, and is expected to achieve the goal of more than 10 new molecular entities entering clinical trials throughout the year.

Regarding R&D strategy and layout, BeiGene said that the company's product portfolio strategy emphasizes the rapid generation of early clinical proof-of-concept data, thanks to its global clinical operation model with speed and cost advantages ("rapid proof-of-concept"). At present, BeiGene's internal clinical operations team has 3,600 people, conducting trials on five continents, and working with regulators and researchers in more than 45 countries to ensure that data quality meets strict standards. BeiGene

said that this strategic model is data-oriented, quickly investing in the most promising and clinically differentiated candidate projects and reducing the priority of other projects to maximize the use of resources. At present, BeiGene has one of the largest oncology research teams in the industry, and is quite strong in the transformational discovery of small molecules and antibody drugs, including three platform technologies: multi-specific antibodies, chimeric degradation activation compounds (CDAC) and antibody-drug conjugates (ADC).

In the third quarter of 2024, BeiGene continued to deepen its global commercialization capabilities, with a record high single-quarter revenue. While accelerating the volume of products, BeiGene continues to promote the research and development process, optimize operational efficiency, and accumulate strength for long-term development.

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