1-3Q24 迪派特和欧优比持续放量。2023 年公司引入欧优比和迪派特两款产品，1-3Q24 产品放量逐季度持续增长，前三季度收入分别为0.24 亿元、0.56 亿元、0.58 亿元，我们认为公司正不断积累商业化运营经验。1-3Q24，公司毛利率79.4%，单三季度毛利率80.7%。1-3Q24 公司销售费用1.32 亿元，同比大幅增长主要由于正式开启产品商业化；管理费用5,777 万元，同比基本持平；研发费用2.19 亿元，同比下降11%。1-3Q24 Revenue Exceeded Our Expectations
The company announced 1-3Q24 results: revenue of 0.139 billion yuan, revenue of 58.46 million yuan in the third quarter. Revenue for the first three quarters was higher than our expectations. Mainly due to the commercialization of Depite and Oubi 4Q23, sales continued to increase; net profit loss to mother of 0.271 billion yuan, net profit loss of 0.286 billion yuan after deducting non-return to mother net profit loss of 0.286 billion yuan, in line with our expectations.
Development trends
1-3Q24 Depat and OUB continue to be released. In 2023, the company introduced two products, Oubi and Depate. The volume of 1-3Q24 products continued to grow quarter by quarter. Revenue for the first three quarters was 0.024 billion yuan, 0.056 billion yuan, and 0.058 billion yuan respectively. We believe that the company is continuously accumulating commercial operation experience. 1-3Q24, the company's gross profit margin was 79.4%, and the gross profit margin for the third quarter of the single quarter was 80.7%. 1-3Q24's sales expenses were 0.132 billion yuan, a sharp year-on-year increase mainly due to the official launch of product commercialization; management expenses were 57.77 million yuan, which was basically the same; and R&D expenses were 0.219 billion yuan, a year-on-year decrease of 11%.
APL-1702 submitted a marketing application, and the international multi-center phase III clinical trial reached the main end point. In May 2024, the company announced that the APL-1702 domestic listing application was accepted by the State Drug Administration. In September, the company released APL-1702 international multi-center phase III clinical data at the 27th National Clinical Oncology Conference and the 2024 CSCO Academic Annual Conference. The response rate of 402 eligible subjects enrolled in the trial between November 2020 and July 2022 increased the response rate of the APL-1702 group by 89.4% (41.1% vs. 21.7%, p=0.0001) compared to the placebo control group, reaching the main end point, and APL-1702, while promoting the reduction of HSIL to LSIL, also showed the ability to cause the high-risk HPV virus to turn negative. We believe that future APL-1702 approval for marketing is expected to bring new treatments for cervical precancerous lesions and removal of the HPV virus.
APL-1706 approved for listing. On November 5, 2024, the company announced that APL-1706 (hexyl aminovalerate hydrochloride for injection) was approved for marketing by the State Drug Administration for cystoscopy in patients with bladder cancer.
We expect that since APL-1706 is an imported drug, it may go through a period of preparation for production after approval before officially starting domestic commercialization.
Profit forecasting and valuation
Considering that the company's commercial revenue for the first three quarters exceeded expectations, we raised our 2024 revenue forecast by 26.9% to 0.165 billion yuan. Considering the increased investment in sales expenses, we have basically kept the net profit forecast loss of 0.47 billion yuan unchanged in 2024, and introduced a net profit to mother forecast loss of 0.285 billion yuan in 2025. Considering the company's future sales and R&D expenses, according to the DCF model, we lowered our target price by 42.0% to 9.6 yuan, with 18.7% upside compared to the current stock price.
risks
Research and development failed, commercialization of products fell short of expectations, and progress of cooperation fell short of expectations.
