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The company released the 2021 performance report: the first product was completed on the market, with an annual operating income of 146 million yuan, slightly exceeding expectations, including KN026 license fee income of 133 million yuan, Envoli monoclonal antibody sales income of 4.4 million yuan, and its royalty income of 7.2 million yuan. During the reporting period, the company's total expenditure was 411 million yuan, and R & D expenditure was 481 million yuan, an increase of 150 million yuan over the same period last year, with a loss of 412 million yuan during the period.
Peace viewpoint:
Differentiated PD-L1 products on the market, entering the first year of commercialization: in November 2021, the FDA conditionally approved the listing of Envoli Monoclonal Antibody (KN035) for the treatment of unresectable or metastatic MSI-H/dMMR advanced solid tumors, becoming the company's first commercial product and the world's first subcutaneous injection of PD-L1 products, with the dual advantages of drug administration and universal indications. 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 product is progressing smoothly, and a number of indications have entered the key clinic: at present, KN046 has launched four registered clinical trials in China, which are first-line chemotherapy combined with chemotherapy for advanced squamous non-small cell lung cancer (III phase clinical). We expect to be on the market in 2023), phase III clinical treatment of PD- (L) 1 for non-small cell lung cancer (completion of the first patient administration), phase III clinical treatment of pancreatic cancer with first-line chemotherapy (completion of the first patient administration) and II phase registered clinical needs of the unmet clinical needs of the sword finger for thymic cancer. In addition, KN046 is currently conducting phase II registered clinical trials of thymic cancer in the United States to further expand the international market and explore the non-health insurance market.
Double antibody combination therapy has entered the registered clinical stage, which brings no choice of chemotherapy for patients: two indications of KN026 are in the late clinical stage, namely, the registration trial of combination chemotherapy in the treatment of second-line HER2-positive gastric cancer, and the II phase of neoadjuvant therapy for HER2-positive early or locally advanced breast cancer (completion of administration of the first patient). In addition, phase III clinical trials combined with KN046 second line treatment for HER2 positive gastric cancer and phase II clinical trials combined with KN046 second line treatment for breast cancer are also being carried out in an orderly manner. As the world's first double-antibody combination therapy, KN026+KN046 is expected to become 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-oriented 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 and will be carried out clinically in the near future, namely KN052 (PD-L1/OX40) and JSKN-003 (HER2 double anti-ADC), to further improve 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 lay out the market ahead of time and occupy a first-mover advantage. Considering 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. It is expected to further enhance the company's performance; 2) A number of key clinical data are expected to be released this year to catalyze the increase in the value of the company. Taking into account possible health insurance negotiations and increased investment in key clinical research and development, we have slightly reduced the company's profit and 23-year revenue. It is estimated that the company's 2022 and 2023 revenue will reach 236 million yuan (236 million yuan), 657 million yuan (743 million yuan) and 1.353 billion yuan (new) in 2024. In 2024, the EPS of 2022Universe 2023 is-0.71 yuan (the previous value is-0.51 yuan),-0.57 yuan (the previous value is-0.07 yuan) and-0.25 yuan (new), respectively, maintaining the "recommended" rating of the company.
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.