Securities code: Betta Pharmaceuticals Co.Ltd(300558) securities abbreviation: Betta Pharmaceuticals Co.Ltd(300558)
Betta Pharmaceuticals Co.Ltd(300558) investor relations activity record
No.: 2022001
□ specific object research □ analyst meeting
□ media interview √ performance briefing
Investor relations □ press conference □ Roadshow
Activity category □ site visit
□ investor exchange meeting
For the names of participating units, please refer to the Annex: list and names of participants in exchange activities
Time: 9:30-10:30, April 7, 2022 (Beijing time)
Location teleconference
Mr. Wan Jiang, senior vice president and chief operating officer
Dr. Wang Jiabing, senior vice president and chief scientist
Ms. Tong Jia, Chief Executive
Reception of listed companies
Name: Mr. Fan Jianxun, vice president and chief financial officer
Dr. Li Ying, vice president
Mr. Ji Dong, vice president
Mr. Wu Lingxi, Secretary of the board of directors
On April 7, 2022, the company, together with Huachuang securities and Haitong Securities Company Limited(600837) held a telephone exchange meeting for the release of annual report performance in 2021. The management of the company had a frank exchange and communication with investors on the operation and management of the company and investor relations activities in 2021. The specific contents are as follows:
Main contents I. operation and market sales of the company in 2021
A: in 2021, the company's operating revenue was 2.246 billion yuan, an increase of 20.08% over the same period last year. The company's star product Kemena has had annual sales of more than 1 billion yuan for six consecutive years since its listing in 2016,
Among them, the sales in 2021 exceeded 2 billion yuan and the cumulative sales exceeded 10 billion yuan, which fully proves the market vitality of Kemena and the strength of the company in the R & D and commercialization of innovative drugs for lung cancer. The company insists on strengthening academic promotion and consolidating the direction of evidence-based medical evidence with the help of clinical trial results, formulates the market strategy of "extraordinary TKI, speak with Chinese data", emphasizes Kemena's differentiation advantages, and further defines Kemena's market positioning of "extraordinary TKI, we are different". In June 2021, Kemena's indications for postoperative adjuvant treatment were approved for listing. Alternative chemotherapy became a better treatment option for postoperative adjuvant treatment of patients with ii-iiiaegfr mutant NSCLC, and was successfully included in the national medical insurance catalogue (2021) at the end of the year.
The sales of the company's second product, bemena, has continued to grow since it was listed at the end of 2020. It has realized the linkage of commercial products with kemmena, and the company's products have formed a collaborative pattern of multiple products. In December 2021, the second-line indications of bemena were included in the national medical insurance catalogue (2021). The company will continue to tap the clinical potential of bemena, fully accumulate evidence of efficacy and safety, guide the market with academic knowledge, and make every effort to build the brand image of bemena.
The company's third product beianting (mil60) was approved for listing in November 2021, which is the company's first approved macromolecular biological product. Its successful listing further enriched the company's product pipeline, marking a big step forward for the company in the field of macromolecular anticancer drugs. At present, betaine has entered major hospitals and pharmacies across the country and began to benefit patients across the country.
With the support of policies, the increase of per capita disposable income and the expansion of the scope of medical reimbursement, there is still a huge space in China's tumor drug market. The company will fully learn from Kemena's successful experience, give full play to its advantageous resources, strengthen the brand construction of products and continuously improve the commercialization ability of products.
2、 Progress of independent research and development of the company
A: the company invested 861 million yuan in R & D in 2021, accounting for 38.32% of the operating revenue. Since the beginning of 2021, the company has successfully promoted the listing of the company's first macromolecular product beianting (mil60), approved the listing of postoperative adjuvant therapy indications of Kemena and first-line treatment indications of ensatinib, 2 candidate drugs / indications NDA (bpi-d0316, CM082) and 1 overseas clinical bed 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).
The company's R & D and innovation ability has been 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 JAMA Oncology; The research results of mil60 were published in eClinical medicine, a sub Journal of lancet respiratory medicine, and ektinib and ensatinib appeared in the national "13th five year plan" scientific and technological innovation achievement exhibition.
3、 Progress of clinical projects of the company
A: at present, the company is developing more than 40 new drug projects, entering more than 10 clinical trials, 2 of which have been applied for NDA, and 3 of which are in phase III clinical trials. Among them, the global multi center phase III clinical trials of ensatinib hydrochloride project are being promoted.
In December 2021, the company's self-developed fourth generation EGFR-TKI bpi-361175 was approved by FDA to enter clinical research, realizing a breakthrough in overseas research of independent innovative drugs.
4、 Strategic cooperation of the company
A: strategic cooperation is an important force for the company's global development. In the past few years, focusing on the R & D pipeline and strategic positioning, the company has reached cooperation with agenus, merus, Yifang biology, tianguangshi, etc., and introduced many new drug varieties with great market value and strategic significance, such as beianting (mil60), bevotinib (bpi-d0316), voronib (CM082), batilizumab (PD-1 antibody) / zefrizumab (CTLA-4 antibody), mcla-129 and mrx2843, enriching the company's existing R & D pipeline. With the promotion of strategic project cooperation, beianting (mil60) was approved to be listed in November 2021, bevotinib (bpi-d0316) applied for NDA in March 2021, voronib (CM082) applied for NDA in January 2022, mcla-129 obtained the notice of approval for clinical trial in March 2021, and batilizumab (PD-1 antibody) / zelacizumab (CTLA-4 antibody) obtained the notice of approval for clinical trial in June and July 2021.
The company's deepening strategic cooperation ability and independent R & D ability form a good complementarity. The company will further strengthen cooperation with Chinese and foreign enterprises in combination with the needs of product layout, and introduce more good projects in the frontier field of cancer treatment.
5、 Influence of star medical insurance company's expected sales price adjustment on kaina products
A: Kemena is the only product in the current generation of EGFR TKI that not only obtains postoperative auxiliary indications, but also enters medical insurance through national negotiation. With the improvement of lung cancer screening level, the detection and treatment of lung cancer will change from late stage to early stage. Kemena has the characteristics of high efficiency and low toxicity, which fully meets the clinical needs of early treatment. After joining the medical insurance catalogue through medical insurance negotiation, the treatment cost of patients can be controlled, which can benefit more early patients.
In July 2021, the study of kaimena postoperative adjuvant therapy, which was jointly led by Professor Zhou caicun and Professor He Jianxing, was published in the full text of lancet respiratory medicine. The results showed that the median DFs in kaimena treatment group was 47 months, which was better than traditional chemotherapy and safer. It established the dominant position of kaimena postoperative adjuvant therapy and included kaimena in the CSCO treatment guide in 2021. Through academic promotion, Kemena has gradually realized alternative chemotherapy in the field of postoperative adjuvant therapy. The company is confident that Kemena will continue to maintain a good market coverage in the lung cancer targeted drug market.
6、 R & D investment of the company
A: the company has always attached importance to R & D and innovation, with high R & D efficiency. Ensatinib hydrochloride and beianting (mil60) invested in the early stage have been listed one after another. In 2021, the company invested 861 million yuan in R & D, accounting for 38.32% of the operating revenue, of which the capitalized R & D expenditure accounted for 34.24% of the R & D investment. With the company's sustained high investment in R & D and the acceleration of new drug R & D, the company's R & D pipeline has become increasingly rich. More than 40 products are under research, and more than 10 have entered clinical research. At present, the company has abundant cash flow and low debt ratio, and there are sufficient ways to raise funds to meet the promotion needs of current research projects.
7、 Research and development progress of EGFR / c-Met double antibody mcla-129
A: mcla-129 is a project jointly developed by the company and merus in the Netherlands. It is intended to be used for the treatment of patients with advanced solid tumors with abnormal EGFR or c-met.
Mcla-129 is a bispecific antibody against EGFR and c-Met. Mcla-129 can block the signal transduction of EGFR and c-Met at the same time, inhibit the growth of tumor, and further enhance the effect of antibody dependent cell-mediated cytotoxicity and phagocytosis (ADCC and ADCP)
Step 1: improve the killing potential of cancer cells.
The application for clinical trial of mcla-129 drug was approved in March 2021. The clinical trial focuses on the efficacy and safety of the drug in the treatment of non-small cell lung cancer with EGFR exon 20 insertion mutation. The research is carried out simultaneously at home and abroad, and the company maintains close communication with merus on development strategy and data verification. At present, clinical research is progressing smoothly.
Annex list of participants in exchange activities
Date: April 7, 2022
