On February 25, 2022, Baiji Shenzhou, the world's first "a + H + n" listed company, announced the US stock performance report for the fourth quarter and the whole year of 2021, as well as the A-share performance express. According to the financial report of US stocks, the company achieved an operating revenue of US $1.2 billion in 2021, about RMB 7.6 billion (the RMB US dollar exchange rate is 1:0.16, and the following uses the RMB unit), a year-on-year increase of 281%. At the same time, the company's net loss decreased by about 1.3 billion yuan compared with the same period last year, a year-on-year decrease of 13%. As many innovative R & D pipelines continue to enter the global harvest period, Baiji Shenzhou is handing over a brilliant answer to the market.
Ou leiqiang, co-founder, chairman and CEO of Baiji Shenzhou, said: "2021 is a transformative year for Baiji Shenzhou. The strategic competitive advantage established by the company has further helped us bring more accessible and affordable innovative drugs to patients around the world."
In 2021, the asset scale of Baiji Shenzhou is also further rising, and the liquidity is significantly enhanced. As of December 31, 2021, Baiji Shenzhou's cash, cash equivalents, restricted cash and short-term investments were about 41.8 billion yuan, an increase of about 12.4 billion yuan compared with the same period last year. Wang Aijun, chief financial officer of Baiji Shenzhou, said: "in the environment of rising capital costs in the whole industry, we have established a strong and stable financial performance and advantageous position."
the scale of revenue has increased nearly threefold, and the core self-developed products cover 45 markets around the world
As a leading enterprise and global explorer of innovative medicine track, in 2021, Baiji Shenzhou continued to show strong market competitiveness and leading industry position. During the reporting period, the accumulated revenue of Baiji Shenzhou reached about 7.6 billion yuan, and the revenue scale increased nearly three times compared with the same period last year. Wind shows that by the end of the first three quarters of 2021, Baiji Shenzhou had ranked first among biotechnology enterprises on the science and innovation board with a total revenue of about 6.227 billion yuan, which was nearly 3 billion yuan lower than that of enterprises in the second place.
It is noteworthy that while the annual report of US stocks was released, Baiji Shenzhou also released the performance express of science and innovation board in A-Shares simultaneously. According to the announcement of the performance express of the science and innovation board, there are certain differences in financial indicators and data according to the different accounting principles and applicable rules for the listing of China and the United States. The complete annual report of A-share Kechuang board will be disclosed in late April.
During the reporting period, Baiji Shenzhou's commercial products contributed the main growth momentum to the company's revenue. In 2021, the product revenue of Baiji Shenzhou reached about 4 billion yuan, with a year-on-year increase of 105%. By the end of 2021, the commercial product portfolio of Baiji Shenzhou had increased to 16 models, ranking in the forefront of China's biotechnology industry.
Among them, the BTK inhibitor baiyueze (zebutinib), independently developed by Baiji Shenzhou, showed a very bright growth performance in 2021. According to the data, in 2021, the cumulative global sales of bayonet was about 1.4 billion yuan, a year-on-year increase of 423%. From the perspective of different market performance, in 2021, the sales revenue of Hyatt in the United States increased significantly. Thanks to the approval of multiple indications in the United States and the expansion of market demand, the revenue of this product in the United States reached about 700 million yuan, a year-on-year increase of 535%. In China, the sales revenue of Baiyue Ze increased by about 600 million yuan, a year-on-year increase of 331%.
As China's first innovative medicine to go to sea, bayonet has been approved by 45 countries and regions in the world, and its global layout is far ahead. In China, one new indication was added to the national medical insurance catalogue at the end of 2021. After the secondary price reduction of medical insurance, it has become the product with the lowest monthly treatment cost of BTK inhibitors in China. With the best curative potential of the same kind and high cost performance, it is expected to further drive the sales volume in the future.
On February 22, Baiji Shenzhou announced that the application for listing of new indications for the treatment of chronic lymphoblastic leukemia (CLL) in the United States and Europe was accepted, and the target decision time of FDA was October 22, 2022. The listing application is based on the positive results of two previous global phase 3 clinical trials, including a head-to-head phase 3 study. Through these two global experiments, the potential of Baiyue Ze to be the "best of its kind" in the world has been further verified. At the same time, it also confirms the forward-looking global R & D strategy of Baiji Shenzhou.
successively won two large "sea" orders from Novartis and realized the first a + H + n listing
Baizean (tirelizumab), another core self-developed drug of Baiji Shenzhou, also achieved several milestones in 2021. By the end of 2021, baizean had 5 indications listed. With the first-line treatment of non squamous non-small cell lung cancer (NSCLC) and other 3 new indications included in the new national medical insurance catalogue, Baiji Shenzhou surpassed Jiangsu Hengrui Medicine Co.Ltd(600276) , Shanghai Junshi Biosciences Co.Ltd(688180) and Xinda biology, making baizean the PD-1 product most included in the medical insurance catalogue.
The demand for new patients brought about by the expansion of the scope of medical insurance reimbursement, the further expansion of the sales team and the increase in the number of drugs entering the hospital have continuously promoted the expansion of baizean's market penetration and market share. In 2021, the total sales volume of baizean in China reached about 1.6 billion yuan, with a year-on-year increase of 56%.
It is noteworthy that in 2021, Baiji Shenzhou submitted to the FDA for the first time the new drug marketing application of baizean for second-line squamous esophageal cancer (ESCC), which is also based on the phase 3 trial data of multiple centers around the world. Statistics show that baizean is currently carrying out about 50 clinical trials in 35 countries and regions around the world, with more than 9000 subjects, of which nearly 3000 are from overseas. Rich global clinical research data escort the sea. In July 2022, baizean is expected to go to sea for the first time.
Baiji Shenzhou's strong R & D capability and product advantages are also constantly attracting the favor of multinational pharmaceutical enterprises and bringing large cooperation income to the company. In January and December 2021, Baiji Shenzhou reached global development and commercialization cooperation with Novartis on baizean and tisperizumab, a tigit inhibitor. The total potential transaction amount brought by the two record global cooperation will exceed US $5 billion.
Strong R & D strength and global layout make Baiji Shenzhou take the lead in the field of biotechnology and continue to consolidate the industry-leading competitive advantage.
On December 15, 2021, Baiji Shenzhou was listed on the science and Innovation Board of Shanghai Stock Exchange, becoming the first biotechnology enterprise in the world to be listed on Nasdaq, Hong Kong Stock Exchange and Shanghai Stock Exchange. This listing has further strengthened the capital strength of Baiji Shenzhou and made the company establish a financial leading position far beyond the industry level. By the end of 2021, Baiji Shenzhou's cash, cash equivalents, restricted cash and short-term investment had reached about 6.6 billion yuan, a year-on-year increase of 42%.
With its competitive advantages in R & D and commercialization, strong BD capability and forward-looking judgment on the market, Baiji Shenzhou has reserved rich cash flow. The increase of capital scale and liquidity makes Baiji Shenzhou have more stable anti risk ability and sustainable business competitiveness. When the industry cycle trough comes, enterprises with "abundant grain and grass" will have more confidence to overcome fluctuations and usher in new growth.
continue to increase the strength of internal independent R & D and make efforts to be the first of its kind in the world
Innovation and R & D are not only the driving force for the long-term development of biotechnology enterprises, but also the core engine and competitiveness of Baiji Shenzhou. Sufficient asset strength has laid a solid foundation for Baiji Shenzhou's deep research and development. In 2021, Baiji Shenzhou's annual R & D expenditure was about 9.5 billion yuan, a year-on-year increase of 15%.
Thanks to the profound R & D layout, Baiji Shenzhou now has nearly 50 clinical stage candidates and commercial stage products. The product R & D pipeline covers many types such as small molecule drugs, monoclonal antibodies, double antibodies and ADC. Many drugs have the potential of differentiation and even "similar initiative". Among them, the tisperizumab, which is currently in the late stage of clinical research, is the third tigit antibody in the world to enter the phase 3 global clinical stage, and is at the forefront of the first echelon of the global competition pattern.
In addition, Baiji Shenzhou has built a global research team composed of more than 700 scientists. In the early exploration stage, Baiji Shenzhou has further expanded the layout of differentiated new drug research and development. According to the data of the company's R & D day in 2021, Baiji Shenzhou has reserved more than 50 ongoing preclinical projects, of which more than half have the potential of "similar initiative".
It is worth mentioning that with years of solid development capacity and sufficient R & D investment, Baiji Shenzhou has established a strong competitive advantage in the global R & D layout and is a well deserved global R & D leader.
At present, Baiji Shenzhou has established international R & D centers in China, the United States, Europe and other major countries in the world. The clinical development team has more than 2200 people. It is one of the largest clinical development teams in the field of cancer in the world. By the end of 2021, Baiji Shenzhou had implemented more than 100 planned or ongoing clinical trials in more than 45 countries and regions, including 38 phase 3 or potentially registered clinical trials, with a total of more than 14500 patients and healthy subjects, of which nearly half were enrolled overseas.
Through the extensive global layout, Baiji Shenzhou has established the key ability of internal implementation of global clinical operation and Drug Administration declaration, which can not only independently and efficiently promote large-scale global clinical trials, but also support the company to apply all over the world with international clinical data, so as to improve the approval efficiency and success rate. For example, in addition to the 45 approved markets, more than 40 registration applications for the drug are under review, which shows the maturity of its international layout.
According to the financial report, Baiji Shenzhou is expected to update the result data of baiyueze in a global head-to-head key test this year to achieve the approval of baiyueze for CLL indications overseas, and plans to be approved in more than 10 other countries. In addition, the target resolution time for the first listing application of PD-1 drug baizean in FDA is July 12, and it is expected to go to sea for the first time this year.
In the harvest period of global R & D and commercialization, Baiji Shenzhou is continuously creating growth. It is worth looking forward to what further answers Baiji China will write in 2022. (Yan Yun)
