The company released its 2022 annual report: total operating income was 212 million yuan, up 651.4% year on year; R&D expenditure was 743 million yuan, down 3.1% year on year; cash and bank balances were 1,492 million yuan, down 14.4% year on year; and the company lost 883 million yuan, up 12.8% year on year. The performance was in line with our expectations.
Nilek was successfully included in the 2022 national health insurance catalogue, which is expected to accelerate its release: from listing in November 2021 until the end of 2022, Nilek's cumulative sales were 182 million yuan. Nelicke is the only third-generation Griffin in China, with a good market competition pattern; it was successfully included in the 2022 national health insurance catalogue with an annual treatment cost of around 174,000 yuan, which is expected to rapidly increase the penetration rate of people with T315I mutants; its indications for treating patients with chronic myeloid leukemia who are resistant and/or intolerant to first-generation and second-generation TKIs are expected to be approved and marketed in the first half of 2023 to further expand the applicable population; patients with slow-grained leukemia have a long survival period, require long-term medication, and have a large stock of patients; its treatment of acute chromosomal positivity in Philadelphia Gonorrheal leukemia patients receive CSCO Recommended by the guide, the market potential is great. Many of the above factors drove Nelicke to accelerate its release.
APG-2575 clinical registration continues to advance, with outstanding safety and efficacy advantages: APG-2575 is the second in the world and the first Bcl-2 selective inhibitor in China that has entered the critical registered clinical stage and has clear curative effects. It is expected to complete the enrollment of key registered clinical patients in 2023 and be marketed in the first half of 2024. Compared to Venecla, APG-2575 has clear safety advantages, faster dose escalation, and lower risk of tumor lysis syndrome. The ORR of APG-2575 combined with BTK inhibitors for R/RCLL/SLL is as high as 98%, which has the potential to become the mainstream medication regimen for CLL/SLL patients in the future, and further increases the possibility of external authorization.
Adhering to the global innovation strategy, the progress of key varieties has been recognized internationally: the company's nine new Class 1 small molecule drugs that have entered the clinical development stage are conducting more than 40 phase I/II clinical trials in China, the US, Australia, Europe and Canada, and have obtained 2 fast-track, 2 rare childhood diseases, and 16 orphan drug qualifications from the US FDA. Received 4 oral presentations and 4 poster presentations at ASH 2022. Furthermore, the company is actively promoting the registration of Nelicke and APG-2575 in the US.
Profit forecast and investment rating: We expect the company's revenue to grow rapidly as Nelicke's sales increase. The estimated revenue for 2023-2025 will be 405/793/1,255 billion yuan, respectively. Considering the company's rapid revenue growth, the first coverage was given to a “buy” rating.
Risk warning: Clinical research and development progress fell short of expectations, and commercialization progress fell short of expectations.