Main points of investment
Revenue from core products continues to grow steadily. In the first half of 2023, the company's revenue was 143 million yuan, an increase of 49 percent over the same period last year. Nerick's product revenue was 108 million yuan, compared with 79 million yuan in the same period in 2022, an increase of 37 percent over the same period last year. Sales in the second quarter increased by 153 percent over the same period last year, and the number of boxes increased by 560 percent.
The increase is mainly due to the volume of sales after Nellick first entered and implemented health insurance prices on March 1 this year.
Nerek pulse first-line treatment of Ph+ ALL, the key registered phase Ⅲ study has been approved by clinical trials. Orebatinib, the first and only third-generation BCR-ABL inhibitor on the market in China, was approved by the Drug Evaluation Center (CDE) of the State Drug Administration (NMPA) on July 6 to conduct a key registered Ⅲ phase study of Nerick combined chemotherapy versus imatinib combined chemotherapy in the treatment of newly diagnosed Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL) patients.
This is an important clinical trial of Nerek pulse Ph+ ALL first-line therapy, and is expected to become the first third-generation TKI drug for first-line treatment of Ph+ ALL.
APG-2575 has made important progress in overseas research and development, and has been approved by FDA to carry out global phase III registered clinical trials. On August 7, the key registered global phase III clinical study of Bcl-2 selective inhibitor Lisaftoclax (APG-2575) was approved by FDA in the United States. This clinical study will use APG-2575 to treat patients with chronic lymphoblastic leukemia (CLL) / small lymphocytic lymphoma (SLL) who have previously received treatment. The approval of this clinical trial is likely to accelerate APG-2575 to become the second Bcl-2 inhibitor on the market in the world, promoting commercial progress. The study is expected to be launched in the second half of 2023.
Profit forecast and valuation: with the sales volume of the core product Nellick entering health insurance, the expansion of APG-2575 indications and the promotion of clinical trials, the company's revenue will continue to grow. We forecast that from 2023 to 2025, the company's income will be 364 million yuan, 507 million yuan and 731 million yuan respectively, and the earnings per share will be-2.77 yuan,-2.20 yuan and-1.60 yuan respectively.
Risk tips: product sales are not as expected, R & D progress is not as expected, market competition is intensified, the risk of a sharp decline in prices, and so on.