Events. The company announces its mid-year report in 2023. The company realized operating income of about 42.4413 million yuan in the first half of 2023, an increase of 62.20% over the same period last year. In the first half of the year, the net profit of return to the mother was 173 million yuan, and the non-net profit deducted by the mother was a loss of 187 million yuan.
Viewpoint: Aikening promotes sales growth rapidly, and the company's commercial expansion is very effective.
1. In 2023, the revenue of H1 company increased significantly, which supported the heavy investment in R & D. The business income mainly comes from Aikoning, a new drug independently developed by the company. Aikoning is the first class 1.1 anti-HIV new drug in China, which is a supplement and promotion to domestic anti-HIV oral drugs, and has differentiated market competitiveness. The company continues to increase R & D investment, spending 110 million yuan on H1 R & D in 2023, an increase of 38.08% over the same period last year, focusing on promoting post-listing research, while steadily promoting the R & D progress and early R & D projects of other products under research.
2. The channel and academic promotion are jointly driven, and the commercial expansion is very effective. Aikening successfully passed the review of the State Drug Administration in the first half of the year, and changed from conditional listing to routine listing, which further determined the clinical safety and effectiveness of Aikoning. Aikening now covers more than 280 HIV designated treatment hospitals and more than 150 DTP pharmacies in 28 provinces and municipalities directly under the Central Government.
3. the channel of globalization is becoming more and more popular. Aikening has obtained drug registration licenses in five overseas countries, including Ecuador, Cambodia, Azerbaijan, Malaysia and Kazakhstan, and seven overseas countries have submitted applications for drug registration.
4. The R & D pipeline will continue to advance and build a complete product matrix. FB1002 maintenance therapy, phase Ⅱ clinical trial in the United States, has completed the enrollment and 52-week treatment and follow-up of all subjects. Multiple drug resistance indications of FB1002 are being carried out in multicenter phase Ⅱ clinical trials. FB3001 has been approved as a modified new drug in the Ⅱ / Ⅲ phase clinical trial.
5. The large-scale production capacity is gradually available, and the production capacity is accelerated. Nanjing Qiandelu Aikening production base has obtained the GMP certificate issued by the Philippine Drug Administration, which can carry out mutual recognition of GMP compliance among PIC/S member countries; the construction of Sichuan Jintang API production base has been completed and the production license has been obtained; the overall construction of Shandong Qihe production base is nearing completion.
Profit forecast and valuation. It is estimated that the company's income from 2023 to 2025 will be 152 million yuan, 316 million yuan and 512 million yuan respectively, an increase of 79.6%, 107.8% and 61.8% respectively over the same period last year; the net profit of returning home will be-152 million yuan,-63 million yuan and-26 million yuan respectively; and the EPS will be-0.41 yuan,-0.17 yuan and-0.07 yuan respectively. Maintain a "buy" rating.
Risk hint: Aikening sales are not as good as predicting risk; R & D failure risk.