Betta Pharmaceuticals Co.Ltd(300558)
Work report of the board of directors in 2021
In 2021, the Communist Party of China ushers in its centennial birthday, and the two Centennial goals meet in history. In addition, the century changing situation is intertwined with the century epidemic. In this context, the company always adheres to the mission of “better medicine, better life” and the development vision of “becoming a multinational pharmaceutical enterprise headquartered in China”. The “troika” goes hand in hand to overcome difficulties and make steady progress in all work.
In 2021, all employees of the company forged ahead and wrote a brilliant report card: the company won the “National May Day Labor Award”, won the first place of China Meheco Group Co.Ltd(600056) new innovative forces for consecutive times, and was rated as one of the top 100 China Meheco Group Co.Ltd(600056) innovative enterprises; Ektinib and ensatinib appeared in the national “13th five year plan” scientific and technological innovation achievement exhibition, and many new drug research achievements were published in international top journals such as lancet respiratory medicine, jamaoncology and eClinical medicine; Dr. Ding lieming performed his duties for the people and actively submitted suggestions on accelerating drug review and approval at the national two sessions.
Part I main financial indicators and management discussion and analysis
(I) main financial indicators
During the reporting period, the company achieved an operating revenue of 2.246 billion yuan, an increase of 20.08% over 2020; The net profit attributable to shareholders of listed companies was 383 million yuan, a year-on-year decrease of 36.83%; The net cash flow from operating activities was 527 million yuan, a decrease of 18.48% over 2020.
Unit: 10000 yuan
Year on year increase / decrease ratio of current year’s amount and last year’s amount (%)
Operating income 22458556187026633755893 20.08%
Total profit 38992756666623 – 2767348 – 41.51%
Net profit 37956076010857 -2215250 -36.85%
Net profit attributable to shareholders of listed companies 38306786063606 – 2232928 – 36.83%
Net profit attributable to shareholders of listed companies after deducting 34568023339289117513 3.52% of non recurring profits and losses
(II) management discussion and analysis
1. Analysis of important indicators
In 2021, the company achieved an operating revenue of 22458556 million yuan, an increase of 20.08% over the same period last year. The net profit attributable to shareholders of listed companies after deducting non recurring profits and losses was 3456802 million yuan, an increase of 3.52% over the same period last year. The main performance influencing factors are as follows:
(1) Ten years of Kemena, ten billion Book legend
2021 is the 10th year of Kemena’s listing, with cumulative sales of more than 10 billion. Under the pattern of listing competitive generic drugs and 4 + 7 volume procurement, the company’s marketing and sales team effectively summarized Kemena’s academic achievements and formulated the market strategy of “extraordinary TKI, speaking with Chinese data”; The clinical medical team continued to carry out Kemena’s clinical research, strengthened academic promotion with the help of clinical trial results, emphasized Kemena’s differentiated advantages, and further clarified Kemena’s market positioning of “extraordinary TKI, we are different”; At the same time, we will promote the commercialization of the medical insurance system of kaina pharmacy and strive to improve the access rate of the company’s medical insurance team across the country. By virtue of Kemena’s advantages in clinical evidence and the unremitting efforts of various teams, we have fully clarified the product advantages with data. Kemena’s market sales have exceeded 10 billion in the past ten years.
(2) Sales contribution increment, bemena can be expected in the future
In November 2020, the Chinese market ushered in the first domestic ALK inhibitor – bemena. The majority of patients with drug resistance after taking kezotinib have the treatment option of domestic innovative drugs. In the face of fierce market competition, the company organized diversified academic promotion activities, created distinctive brand conferences, and stepped up to create the differentiated advantages of bemena. Meanwhile, in December 2021, the second-line indications of bemena were included in the national medical insurance catalogue (2021); The first-line indications were approved in March 2022, and the future market can be expected.
(3) The pipeline continues to expand after the launch of betaine
In November 2021, the company’s third new drug beianting was approved for listing, which is the company’s first approved macromolecular biological product. Its successful listing marks a big step forward for Betta Pharmaceuticals Co.Ltd(300558) to the field of macromolecular anticancer drugs and further enriches the company’s product pipeline. At present, betaine has entered major hospitals and pharmacies and began to benefit patients all over the country. The company will make full use of its advantageous resources to speed up the national network and clinical application of betaine and continue to increase its brand construction.
(4) High investment in R & D, good at cost management
In the fierce market competition, Kemena continued to increase in volume, and beimena’s sales accelerated. The annual operating revenue was 2.246 billion yuan, a year-on-year increase of 20.08%; The cash flow is sufficient, the operating cash flow is higher than the net profit, and the cash content of the net profit is 139%. New drug R & D projects continued to be promoted. In 2021, R & D investment was 861 million yuan, accounting for 38.32% of operating revenue; Under the high growth rate of 55.97% of R & D expenses, the net profit attributable to shareholders of listed companies after deducting non recurring profits and losses was 346 million yuan, a year-on-year increase of 3.52%; The expenses of sales, management and finance were well controlled, with a year-on-year increase of 15.49%, lower than the growth level of operating revenue. The company has formed a good sense of input-output efficiency; At the same time, through budget management, bidding and inquiry management, cost assessment, system control and other mechanisms, the use of expenses during the period is reasonable.
2. Main business conditions
1) Innovative and enterprising, and fruitful new drug research and development
Betta Pharmaceuticals Co.Ltd(300558) is the first batch of innovative biopharmaceutical companies in China. Innovation is the core strategy that the company always adheres to and the Beijing Dynamic Power Co.Ltd(600405) spring that promotes the steady development of the company. The company has built a leading new drug R & D system in China.
In 2021, the annual R & D investment reached 861 million yuan, accounting for 38.32% of the operating revenue.
Since the beginning of 2021, Betta Pharmaceuticals Co.Ltd(300558) has successfully promoted the company’s first macromolecular product listing (betaine), the indication of postoperative adjuvant therapy of Kemena and the indication of first-line treatment of ensatinib, and two candidate drugs / indications NDA (bpi-d0316, CM082) and one overseas clinical bed have been approved by FDA (bpi-361175), And 11 candidate drugs / indications ind (bpi-23314, bpi-361175, bpi-21668, bpi-421286, batilizumab alone and in combination with zefrizumab, bpi-16350, bpi-371153, bpi-442096, indications for adjuvant therapy after nsatinib). As of the date of issuance of this report, several projects in the pipeline under research of the company and its subsidiaries are in the clinical stage of registration, and two projects have submitted drug registration applications. The company will go all out to promote the progress of the project.
In 2021, the company’s innovation ability was recognized by many industry experts and institutions. The research results of ektinib evolution were published in Lancet respiratory medicine; The global first-line exalt 3 research results of ensatinib were published in jamaoncology; The research results of mil60 were published in eClinical medicine, a sub Journal of lancet respiratory medicine, and the academic research was fruitful. Ektinib and ensatinib appeared in the national “13th five year plan” scientific and technological innovation achievement exhibition. The company ranked first among China Meheco Group Co.Ltd(600056) new innovative forces and was rated as one of the top 100 China Meheco Group Co.Ltd(600056) innovative enterprises.
2) Extraordinary TKI has made new breakthroughs in market access
At the end of 2021, in addition to the conventional indications, the new indications for postoperative adjuvant treatment of ektinib were also successfully admitted to the national medical insurance catalogue (2021). Relying on the national medical insurance catalogue and the national catalogue of essential drugs, the company continued to strengthen the development of target hospitals, improve the coverage of hospitals, actively promote the medical insurance access of national pharmacies, and fully ensure the growth of sales of ektinib. At the same time, the company actively responded to the new policies of all provinces (cities), visited key customers with high frequency and efficiency, formulated appropriate countermeasures and solutions, actively sought the policy support of relevant departments, created a good business operation environment, and maintained the stability of Kemena’s price.
The company firmly grasped Kemena’s core positioning of “extraordinary TKI, we are different” and implemented differentiated competition. Kemena is the most clinically studied EGFR-TKI in Chinese patients. So far, there have been more than 90 clinical studies related to Kemena, and more than 200 SCI papers have been published (including 9 papers with more than 10 influencing factors), with a total of more than 800 influencing factors. Abundant clinical data and real-world evidence fully confirm Kemena’s “we are different”. We are confident to share more responsibilities with relevant national departments to effectively solve the treatment problems of Chinese lung cancer patients.
Based on Kemena’s own differentiation advantages, the company’s commercialization team made full efforts. On the one hand, it continuously strengthened the construction of academic brand, held thousands of academic activities such as Kemena’s listing Academic Summit, one question and one answer multidisciplinary brainstorming and “Beijia forum” in the form of Wuxi Online Offline Communication Information Technology Co.Ltd(300959) combination, creatively launched special department meeting projects, and comprehensively demonstrated the academic advantages of Kemena and beimena to experts and patients; On the other hand, in the aspect of market access, the company actively responds to the changes of national and provincial market access policies, timely formulates countermeasures and solutions, and effectively ensures the continuity of drug use and the convenience of drug purchase.
3) Broaden thinking, strategic cooperation “bring in, go out”
While continuously strengthening independent innovation, the company continues to strengthen strategic cooperation support, adhere to the working idea of combining “bringing in” with “going out”, focus on the unmet clinical needs and the company’s overall strategy, actively connect with the world’s excellent team of scientists, leading technologies and innovation projects, carry out diversified and multi-level cooperation, and further promote the development and cooperation of independent innovation projects in the world.
In December 2021, xcovery holdings, Inc., an overseas subsidiary of the company, announced that it controlled meryx Inc. by acquiring a majority stake. Previously, Betta Pharmaceuticals Co.Ltd(300558) and meryx reached a strategic cooperation on the project of mrx2843, a dual inhibitor of MERTK and FLT3. In this cooperation, xcovery will work with meryx to accelerate the preclinical development and clinical research process of the cooperation project, further deepen the cooperation in the research and development of small molecule tumor targeted drugs, and strive to develop more therapeutic drugs with clinical value to benefit patients all over the world.
Through strategic cooperation, we have rapidly enriched the pipeline under research and opened up the exploration road of sequential treatment and combined immunotherapy. Through careful management of the cooperation project, beianting (mil60) was approved for listing in November 2021; Bevotinib (bpi-d0316) applied for NDA in March 2021, and voronib (CM082) applied for NDA in March 2021
Apply for NDA in January 2022; Mcla-129 obtained the clinical trial approval notice in March 2021, and batilizumab (PD-1 antibody) / zefirizumab (CTLA-4 antibody) obtained the clinical trial approval notice in June and July 2021. The company has made important progress in several projects introduced through strategic cooperation, and the results of cooperation are increasingly apparent.
4) Rapid development, production quality control support
The company is in the stage of rapid development, and the R & D pipeline is thickened and gradually realized. During the reporting period, the company’s production plan was promoted in an orderly manner: Kemena produced more than 3.21 million boxes, an increase of 25.84% over the previous year, and the annual product qualification rate was 100%; More than 270000 boxes of bemena have been produced, and the annual product qualification rate is 100%, which fully ensures the medication of patients. At the same time, it has completed the production and supply of clinical research drugs for bpi-16350, bpi-23314, bpi-27336, bpi-28592, bpi-43487, mrx2843, bpi-21668, bpi-361175, bpi-421286 and other projects, effectively escorting the R & D of the company. The effective operation of the production quality system has solved the worries for the development of the company.
Part II daily work of the board of directors
In 2021, the board of directors of the company further improved the corporate governance structure, actively performed various responsibilities of the board of directors, earnestly implemented various resolutions of the general meeting of shareholders, and all directors were diligent and conscientious in accordance with the provisions of the company law, the securities law, the guidelines for the standardized operation of companies listed on the gem of Shenzhen Stock Exchange and the articles of association, Promote the steady development of the company. (I) board meetings held by the company this year
In 2021, the board of directors of the company held 13 meetings of the board of directors. The convening procedures of the meetings were in line with the relevant provisions of the company law, the articles of association and the rules of procedure of the board of directors. The meetings were legal and effective. The details are as follows:
meeting
