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The company released the 2022 half-year performance report, 2022H1 achieved operating income of 75 million yuan, an increase of 234.7% over the same period last year, basically in line with expectations, of which Envoli monoclonal antibody sales revenue was 54 million yuan. During the reporting period, the company lost 147 million yuan and spent 216 million yuan on research and development. Up to now, the company's paper cash reserve is 1.709 billion yuan, which is still relatively sufficient.
Peace viewpoint:
Differentiated PD-L1 products are on the market, entering the first year of commercialization. So far, as the world's first subcutaneous injection of PD-L1 products, Envoli has benefited more than 10000 patients and has been listed in three 2022 CSCO guidelines. In order to further expand the indications, the company is also conducting a registered phase III clinical trial of biliary cancer and a second-line treatment of MSI-H/dMMR endometrial cancer combined with lenvatinib. At the same time, the clinical indications of soft tissue sarcoma promoted by overseas and partners are also advancing in an orderly manner.
The fist products are progressing smoothly, and a number of indications have entered the key clinic. At present, KN046 has launched four registered clinical trials in China, namely, first-line chemotherapy combined with chemotherapy for advanced squamous non-small cell lung cancer (III phase), combined with lamvatinib for PD- (L) 1 after treatment of non-small cell lung cancer III phase clinical (in dose exploration stage), combined with chemotherapy for pancreatic cancer phase III clinical (complete more than 50% of patients enrolled) and II phase registered clinical treatment for thymic cancer The unmet clinical needs of sword finger bring more treatment options for patients. The company expects to submit two listing applications for KN046 in the treatment of squamous non-small cell lung cancer and pancreatic cancer to CDE in 2023. In addition, KN046 is currently conducting a phase II registered clinical trial of thymic cancer in the United States to further expand the international market. Double-antibody combination therapy has entered the registered clinical stage, which brings patients the choice of no chemotherapy: KN026 has also entered the registered clinical stage, and the indication is combined chemotherapy for second-line HER2-positive gastric cancer. In addition, the company's first registered clinical trial of biantibody combination therapy is also in progress for KN026+KN046 first-line treatment of gastroesophageal junction cancer, and clinical applications have been accepted by CDE, which is expected to be the potential optimal treatment for HER2-positive tumors, providing patients with treatment options without chemotherapy.
Rich technology platform empowering pipeline development. The company focuses on the development of antibody-based tumor therapy-related technologies and platforms, with the ability to develop various forms of protein building blocks for structure-directed protein modification. With its strong R & D strength, the company has built a number of technology platforms, including CRIB, which is scarce in China, fusion protein technology platform based on single-domain antibody as basic block, innovative double-antibody derivative platform based on unique glycosylation coupling, and so on. Using these independent technology platforms, the company continues to enrich the product pipeline. At present, two models of IND have been approved, namely KN052 (PD-L1/OX40) and JSKN-003 (HER2 double anti-ADC). At present, they have promoted the clinical practice and further improved the company's R & D echelon.
Maintain the company's "recommended" rating. As a company with a strong anti-R & D platform and a global leader in product progress, the company is expected to be able to layout the market ahead of time and occupy the first-mover advantage. Taking into account the good development prospects of the company's industry and the company's leading position in the industry, we maintain the company's "recommended" rating: 1) the company has a rich independent technology platform and will still have a rich pipeline layout in the future, which is expected to further enrich the company's performance; 2) A number of key clinical data are expected to be released this year, including II data for KN019 treatment of RA, which will catalyze the increase in the company's value. We maintain our previous forecast that the company's revenue in 2022, 2023, and 2024 is expected to reach 2.36, 6.57 / 1.353 billion and-0.71, respectively, in 2024, and the EPS of 2023 is-0.71, 0.56 and 0.25 respectively.
Risk hint: 1) Research and development risk: double resistance products are basically still in the stage of research and development, and new drug research and development is affected by many factors, such as capital, policy, technology and so on. there is the possibility that the progress is less than expected or even failure; 2) sales risk: the company has no product commercialization experience, the ability of the sales team has not been verified, and there may be a risk that the promotion may not be as expected after the drug is put on the market in the future. 3) the competition aggravates the risk: there may be more enterprises laying out the double resistance areas in the future, leading to the deterioration of the competition situation; 4) Policy risk: as an emerging technology, there is a risk of changes in industry regulatory policies.