On February 26th, BeiGene (NASDAQ code: BGNE; Hong Kong Stock Exchange code: 06160.HK; Shanghai Stock Exchange code: 688235. SH) released its 2023 fourth quarter and full year US stock performance reports, as well as the 2023 A-share performance report. In 2023, the company's annual performance reached a new historical high, with a total revenue of 2.5 billion US dollars, a year-on-year increase of 74%. Global product revenue continues to rise, generating $2.2 billion in revenue, a year-on-year increase of 75%.
Among them, the two core self-developed drugs of BeiGene have made significant progress. BTK inhibitor Baiyue Ze& Reg; Zebtinib's global sales have surpassed the $1 billion mark for the first time, with annual sales reaching $1.3 billion, becoming the first "billion dollar figure" in China. Anti PD-1 antibody Baizean& Reg; Pioneering a "zero breakthrough" in the field of PD-1 and obtaining approval in the European Union and the United Kingdom. From then on, Baekje also achieved the transition from "single soldier combat" by Zebtini to today's "double hundred going to sea".
John V. Oyler, co-founder, chairman, and CEO of BeiGene, stated, "Looking back at the fourth quarter and full year of 2023, BeiGene has made significant progress towards becoming an influential next-generation cancer innovation company.". We look forward to a transformative breakthrough for BeiGene in the new year, by driving significant revenue growth in different regions around the world and continuously achieving excellent operations
The first "billion dollar molecule" was born
It is worth mentioning that with the continuous implementation of strict expense management by the company, the operating loss for the whole year of 2023 narrowed by 33% year-on-year, and the operating efficiency further improved. With the company's global revenue continuing to maintain strong momentum and continuously improving operational efficiency, it is expected to usher in a new stage of growth.
From a quarterly performance perspective, BeiGene's total revenue in the fourth quarter was 634 million US dollars, a year-on-year increase of 67%, and product revenue was 630.5 million US dollars, a year-on-year increase of 86%. As a pioneer in innovative drugs going global, BeiGene has established a diversified product and regional revenue portfolio, leading the way in internationalization.
From the perspective of product revenue composition, Zebtinib, as a star product of BeiGene, contributes more than half of the sales revenue. In the fourth quarter of 2023, Zebtinib's global sales reached $413 million, a significant increase of 135% year-on-year. In 2023, global sales of Zebutinib exceeded the milestone of $1 billion, reaching $1.3 billion, a year-on-year increase of 129%, officially entering the ranks of blockbuster drugs. Meanwhile, this is also the first "billion dollar molecule" independently developed by BeiGene.
In the global biopharmaceutical industry, drugs with annual revenue exceeding $1 billion are often referred to as "bombshell" drugs. The birth of a "heavyweight bomb" drug not only signifies a milestone commercial achievement for the enterprise, but also proves that the drug has the ability to transform treatment. Statistics show that the annual appearance of "blockbuster" drugs usually takes about 10 years from their first launch. Since its first approval in the United States in 2019, Zebutinib has become a "bombshell" drug in just four years, which also confirms the diversity and transformative nature of this drug.
Creating a "heavyweight bomb" drug not only tests a company's research and development strategic capabilities, but also poses a comprehensive challenge to global business layout and supply chain, and the difficulty is self-evident. In terms of drug development alone, according to statistics, the average cost of successfully developing a drug is 2.6 billion US dollars, with an average time of over 10 years and a success rate of only 7.9%. The breakthrough of Zebutinib in the $1 billion mark not only confirms the success of the globalization path of BeiGene, but more importantly, it breaks the record of domestic innovative drugs without a "heavy bomb" drug, which is of great significance.
The rapid success of Zebtinib is not accidental, as it is inseparable from forward-looking global research and extensive commercial layout. Previously, in the global phase 3 head to head ALPINE trial, long-term follow-up data showed that Zebutinib continued to demonstrate superior efficacy and safety compared to Ibrutinib, confirming its global "best in class" advantage. Nowadays, Zebutinib has been approved in over 65 markets worldwide, including many developing and emerging markets such as Thailand, Ecuador, and Uruguay, and has become the most widely applicable BTK inhibitor.
The financial report shows that BeiGene is continuously investing in the commercialization and listing of Zebtinib globally. With a strong global commercialization team of over 3500 people, it is expected to obtain more approvals in new regions and indications, benefiting a wider range of global patients.
Accelerate the wave of innovation and research and development
Zebtinib's entry into the "billion dollar molecule" is only the initial success of BeiGene in the field of cancer, supported by a huge pipeline pipeline. In mid-2023, another self-developed PD-1 product from Baekje Shenzhou, Baekze An& Reg; (Tetrazolizumab) also achieved impressive results, with annual sales of 537 million US dollars, including sales of 128 million US dollars in the fourth quarter.
In China, Terezumab has established a leading market position with its unique product advantages. At present, Tirolizumab has been approved by the National Medical Products Administration for 12 indications, of which 11 are included in the list of medical insurance drugs. It is also one of the PD-1 products with the highest number of indications, widely covering high-risk cancers such as lung cancer and liver cancer in China.
In 2023, Tirizumab was approved in the European Union and the United Kingdom, marking a breakthrough in the zero export of PD-1 products. Meanwhile, it is currently undergoing regulatory review in 10 markets worldwide. In the United States, tirizumab is expected to receive FDA approval within this year for first-line and second-line treatment of esophageal squamous cell carcinoma (ESCC), further expanding its global footprint.
More importantly, in the field of PD-1, the exploration of combination therapy has become an important development opportunity. Currently, as an important combination drug, tirelizumab is being studied in combination with over 40 molecules, including LAG3, TIM3, OX40, HPK1 inhibitors, etc.
In terms of follow-up pipelines, BeiGene's leading position in the field of hematology has gradually become prominent. The BCL2 inhibitor sonrotoclax has the potential to be the "best in class" and has launched four global registered trials, including the global phase 3 registered trial for first-line treatment of chronic lymphocytic leukemia (CLL). The differentiated BTK CDAC project BGB-16673 initiated two global extended cohort studies targeting BTK inhibitor resistant patients and a broader patient population.
At present, BeiGene is developing over 50 drug pipelines, covering various technology platforms and drug models, including monoclonal antibodies, dual antibodies/multi antibodies, ADC, cell therapy, mRNA, etc. With an outstanding research team, in 2023, BeiGene will promote 5 new molecular entities into clinical practice, including potential "best in class" CDK4 inhibitors. The financial report shows that BeiGene is expected to launch the first human clinical trials of at least 10 new molecular entities in 2024, accelerating the next phase of research and development.
In addition, in terms of production and operation, the global factories of BeiGene are expected to experience "multi-point flowering" this year. The total production capacity of the Guangzhou biopharmaceutical production base has reached 65000 liters, and the ADC production facilities and the new biopharmaceutical clinical production building have been completed; The small molecule innovative drug industrialization base newly built by the company in Suzhou has also been completed, and the solid formulation production capacity has been expanded to 1 billion tablets (granules) per year; The biopharmaceutical production base and clinical research and development center located in New Jersey, USA are about to be completed and are expected to be operational in July 2024.
Analysts point out that from this "transcript" of BeiGene, it can be seen that it has established strong global capabilities in commercialization, research and development, and production. Meanwhile, with the continuous improvement of operational efficiency and further reduction of losses, the company has laid a solid foundation for achieving sustained growth and opened a new chapter in global development.