21st Century Business Herald reporter Ji Yuanyuan Shanghai reported that on February 26th, BeiGene announced its US stock market performance reports for the fourth quarter and full year of 2023, as well as the 2023 A-share performance report. According to financial report data, in 2023, the total revenue of BeiGene reached 2.5 billion US dollars, a year-on-year increase of 74%. Global product revenue reached 2.2 billion US dollars, 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".
In addition, according to the financial report, BeiGene's operating losses for the whole year of 2023 narrowed by 33% year-on-year. 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%.
2023 is considered a highly transformative year, and under the multiple impacts of domestic and international environments, the innovative pharmaceutical industry is accelerating its reshuffle, and the industrial structure may face a new round of restructuring. From the report card submitted by BeiGene, it can be seen that the innovative pharmaceutical industry has not stopped due to market changes. Whether it is policy support, capital markets, or overseas development, it is necessary to find opportunities in the process of change.
The Birth of Billion Dollar Molecules
A major highlight of this financial report from BeiGene is that, in terms of product revenue composition, Zebtinib, as a star product of BeiGene, contributed more than half of its sales.
According to the financial report, 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.
This is also due to the fact that Zebutinib has been approved in over 65 markets worldwide, including many developing countries and emerging markets such as Nicaragua, Thailand, Ecuador, Uruguay, and has become the most widely applicable BTK inhibitor.
At the product layout level, in addition to BTK inhibitors, PD-1 is also a major core competitive area that innovative pharmaceutical companies focus on. According to the financial report, BeiGene PD-1 product Bazawa An& Reg; The annual sales of (Terezumab) reached 537 million US dollars, with sales in the fourth quarter reaching 128 million US dollars. 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 the PD-1 product with the highest number of indications, widely covering high-risk cancers such as lung cancer and liver cancer in China.
BeiGene is still exploring the market potential of PD-1 products. According to a reporter from 21st Century Business Herald, BeiGene is currently developing a subcutaneous injection formulation of tirizizumab, which will be launched in clinical practice in 2023.
At present, the dosage form of PD-1 products in China is mainly intravenous injection. Compared to oral administration, compliance is not as easy, especially for subsequent monotherapy. Patient follow-up and infusion issues still need to be addressed urgently.
"I am also a patient's family member, so I have a deep understanding that when my family goes for treatment, it takes several hours to sit down each time. Not only is the patient's experience poor, but the people next to me are also exhausted." Yin Min, Chief Business Officer of BeiGene Greater China, said in an interview with 21st Century Business Herald reporters recently. The next step for BeiGene is to focus more on patients from the overall plan, Pay attention to patient experience and quality of life, and truly serve patients well.
"I am wondering if we can improve our services and provide standardized solutions for patients' problems. We can spread scientific knowledge and enhance public awareness of diseases by supporting specialized science education and other means." Yin Min emphasized, "At present, this is just an idealized idea and attempt, and we don't know if this path can be made. However, based on the feedback we have collected from countless patients, this includes huge unmet needs of patients. We are already thinking about how to better serve patients. Although these ideas still need to be explored in practice, we are willing to wade the road, create some models, and verify together."
Innovative drugs move towards a "rational return"
From the financial report of BeiGene, it can be seen that after years of accumulation, innovative pharmaceutical leading enterprises have established strong global capabilities in commercialization, research and development, and production. And financial report data also 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.
A pharmaceutical industry analyst from a securities firm pointed out to 21st Century Business Herald reporters that although Biotech's pace of progress has slowed down in the past two years, it is not stagnant. From the long-term development curve of the biopharmaceutical industry, it can be seen that the industry is currently moving towards a more mature and rational stage, and "stable while improving" may become the tone of industrial development.
"The underlying logic of the biopharmaceutical market remains unchanged, and competitive advantage and profit growth stem from constantly breaking product innovation and continuously growing market demand. Faced with future uncertainty, companies should proactively innovate their development strategies, enrich their self-developed capabilities, broaden their international perspective, and improve their adaptability to overcome the current downturn, preparing to lead the next stage of new growth," said the analyst.
Throughout the years, innovative drugs have faced many uncertain factors from drug discovery to preclinical trials, to clinical trials and commercial launch. In addition, the external economic environment and rational return of capital markets have also affected the return rate of innovative drug companies, which has attracted much attention. Behind the reduction of expenses and pipelines in the past two years is actually a focus on innovation and rational stability. Focusing on advantageous tracks, optimizing pipeline layout, and integrating resources into core projects can help innovative pharmaceutical companies improve resource utilization efficiency and reduce the uncertainty of overall R&D investment.
Currently, the research and development strategies of innovative pharmaceutical companies are gradually maturing. With some pipelines advancing towards the later stage, they are shifting from expanding pipeline strategies to lean and efficient development, focusing on investing in pipelines with high innovative technology content and outstanding clinical value. The above analysts further pointed out that adopting a lean research and development strategy can, on the one hand, achieve the effect of "concentrating efforts to accomplish big things", and is expected to accelerate the launch of innovative drugs and achieve innovation returns; On the other hand, the integration and optimization of resources can help innovative pharmaceutical companies smoothly navigate the current "changes".
The medical industry is influenced by many factors such as macroeconomic factors, national policies, and breakthrough technologies, and its development has its own unique cyclical characteristics. In the past few years, investment and financing in the global medical and health industry has been on the rise. Later, with the slowdown of macroeconomic development and the chill of the capital market, the activity began to decline. The emergence of "de foam" is a rational and mature performance of the pharmaceutical industry. When the foam disappears, truly outstanding enterprises will grow up and become globally competitive companies.
Since 2023, China's pharmaceutical industry has continued to steadily move forward despite a cooling cycle. For example, the negotiation rules for medical insurance are more clear, while supporting the development of innovative drugs. The negotiation of 23 innovative drugs outside the catalog was successful, with a success rate of 7.4 percentage points higher than the overall success rate and an average price decrease of 4.4 percentage points lower. Secondly, innovative drugs have once again reached a small peak when going global. Innovative drug products from BeiGene, Junshi Biotechnology, Yifan Pharmaceutical, and Hehuang Pharmaceutical have been successfully approved for overseas listing, and China's innovative research and development capabilities have been recognized again. In addition, there is a large population of patients in our country, and many clinical needs still need to be met. The improvement of patient health literacy drives the further release of these needs, which in the long run drives the development of the pharmaceutical industry.
Faced with a complex development environment, enhancing innovation capabilities, optimizing effective resource combinations, and improving operational quality are key factors for pharmaceutical companies to achieve sustainable development. Some pharmaceutical executives also emphasized to 21st Century Business Herald reporters that current innovative pharmaceutical companies need to focus on the following three points:
Firstly, enterprises should attach importance to continuously promoting innovation and research and development, and establish technology platforms with high technological barriers and independent intellectual property rights;
Secondly, building a differentiated innovation pipeline, focusing on core pipelines, and developing products that can meet high clinical needs;
Thirdly, establish a strong R&D team and actively introduce innovative talents from home and abroad. In terms of improving business quality, actively promote BD work, pay attention to patient needs and market dynamics, and proactively adjust strategic decisions;
Fourthly, pay attention to overseas markets, seek partners or establish a self built overseas operation team, and seek more commercial value through going abroad;
Fifthly, consider more flexible and diverse ways to introduce funds, such as technology authorization, clinical pipeline investment in joint ventures, etc., to raise funds and share research and development risks.
"Continuous innovation remains the driving force and core competitiveness of the pharmaceutical market. In the face of changes, many enterprises are also focusing on innovation, including increasing investment in innovation pipeline development, developing differentiated technology path products, introducing innovative talents, and combining artificial intelligence and other innovative technologies." The executives of the pharmaceutical company believe that in addition, the vast overseas market is also a choice for domestic enterprises to cope with the uncertainty of the current environment, For example, Biotech implementing License out and collaborating with large pharmaceutical companies can complement each other's advantages, obtain certain cash flow, and concentrate resources to promote pipelines.