What happened: the company recently released its annual report for 2021, with a revenue of 28.77 million yuan in 2021, mainly from the "designated patient Drug use Plan", government subsidies and bank interest income of 42.57 million yuan. The R & D expenditure was 405 million yuan, and the sales and distribution expenditure was 67.94 million yuan. The adjusted loss for the year was 613 million yuan, an increase of 34.84% compared with the loss in 2020. As of December 31, 2021, the company's cash, bank balances and cash management products were RMB 2.37 billion.
Comments:
(1) Sereniso has been approved in China, Australia, South Korea and Singapore, and the commercialization team has reached 170.
Seriniso (Sivio) is the first commercial product of Deqi Pharmaceutical and the first + only nuclear output inhibitor (SINE) drug approved for XPO1 targets in China and the Asia-Pacific region. it was conditionally approved by NMPA in December 2021 for use in combination with dexamethasone. Adult patients with relapsed or refractory multiple myeloma who have been previously treated with at least one protease inhibitor, one immunomodulator, and one anti-CD38 monoclonal antibody. At the same time, by March 2022, Serineso has been approved for listing in South Korea, Australia and Xinjiapo, and is expected to be approved in Hong Kong and Taiwan in 2022. The size of the commercialization team in the Asia-Pacific region has reached about 170, with a sales target of 180-200 million yuan in 2022. Several Serinisol combination therapies for the treatment of multiple myeloma and lymphoma were recommended by the 2021 guidelines of the Chinese Society of Clinical Oncology.
(2) five registered studies of Sereneso are being carried out in China, and three global equity assets have entered the stage of clinical development.
ATG-010 Sereniso is conducting five registered studies in China, including three global studies jointly conducted by Karyopharm. In addition to multiple myeloma, Serinesol / SINE has the potential to expand indications in the fields of lymphoma, endometrial cancer, leukemia and so on. At the same time, the company has 10 global equity assets with high diversity and joint-use potential, 3 of which have entered the clinical stage. In December 2021, the company entered into a partnership with BMS for the clinical development of ATG-017 (ERK1/2 inhibitor) combined with Navuliu.
Deqi Pharmaceutical production Base has been completed in Shaoxing Binhai New Town Life and Health Science and Technology Industrial Park. It will begin to receive production technology transfer from Serineso in 2022 and is now applying for a production license with the Drug Administration of Zhejiang Province. At the same time, the company has signed a framework agreement in May 2021 to build the R & D and industrialization base of antibody preparations in Qianjiang New area of Hangzhou.
Profit forecast: we expect the company's net profit in 2022-2024 to be-724 million,-741 million and-388 million respectively, and the EPS in 2022-2024 will be-1.09yuan,-1.11yuan and-0.58yuan respectively, covering for the first time and giving the company a "recommended" investment rating.
Risk hints: the competition pattern changes more than expected; the progress of product research and development falls short of expectations; the impact of the epidemic exceeds expectations.