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艾力斯(688578):伏美替尼持续高速放量 海外EX20INS NSCLC一线市场值得期待

Alice (688578): Continued rapid release of vometinib in overseas EX20INS NSCLC first-tier markets is worth looking forward to

安信證券 ·  Oct 27, 2023 15:06

Event: the company announced its three-quarter report in 2023. During the reporting period, the company realized operating income of 1.348 billion yuan, an increase of 160.34% over the same period last year. It realized a net profit of 410 million yuan, an increase of 661.00% over the same period last year. It deducted a net profit of 380 million yuan, an increase of 1869.27% over the same period last year. Among them, Q3 realized operating income of 599 million yuan in 2023, an increase of 175.67% over the same period last year; net profit of 202 million yuan, an increase of 643.57% over the same period last year; and non-return net profit of 196 million yuan, an increase of 1226.74% over the same period last year.

With the continuous high-speed volume of Vumetinib, the company's outstanding commercialization ability in the field of lung cancer has been verified. Since 2023, driven by the continuous high-speed volume of the third-generation EGFR inhibitor Fumetinib, the company's Q1-Q3 revenue has been 277 million yuan, 472 million yuan and 599 million yuan respectively, with a month-on-month growth rate of 1.5%, 70.4% and 26.9% respectively, with a total operating income of 1.348 billion yuan in the first three quarters. At present, there are four third-generation EGFRmut NSCLC inhibitors, including AstraZeneca PLC's Oshitinib, Hansen's ametinib, Alice's Fumetinib, and Beida's Befortinib, which was approved to go on the market in May this year. The company's Vumetinib has achieved sustained high-speed volume in the above product competition, which proves the company's outstanding commercialization ability in the field of lung cancer.

Fumetinib ex20ins NSCLC first-line data is excellent, overseas markets are worth looking forward to.

Currently, the company has launched a three-phase registered clinical study (FURMO 004 study) for ex20ins NSCLC, which is the first global, phase 3, multicenter, randomized, open-label study launched by the company in cooperation with ArriVent. Domestic clinical research is carried out by the company, foreign clinical research is carried out by ArriVent, domestic clinical research IND was approved in April 2023, foreign clinical research has been approved to enter the clinical stage in the United States, France, Japan and other countries, and the first overseas patient has been enrolled in the group in the first half of this year.

The ex20ins NSCLC first-line early data disclosed by the company at the WCLC 2023 conference are excellent, with cORR up to 78.6% in the 240mg dose group, and the non-head-to-head comparison is similar to the 73% of Johnson & Johnson EGFR × c-Met double antibody + chemotherapy, but considering the convenience and safety advantages of small molecule monotherapy, we think it is worth looking forward to in the overseas market in the future.

Investment suggestion: from 2023 to 2025, we expect the company's income to grow by 136.2%, 28.4% and 27.1% respectively, and net profit to grow by 358.7%, 35.0% and 30.4% respectively, corresponding to EPS of 1.33,1.80,2.34 yuan and PE of 26.8,19.8 and 15.2 times, respectively. We give the company 30 times PE in 2023, corresponding to the 6-month target price of 39.91 yuan, and give the buy-An investment rating for the first time.

Risk hints: the risk that a single large variety of fumetinib is not sold as expected, the risk that the progress of overseas clinical trials is not as expected / failure, and the risk of medical policy change.

The translation is provided by third-party software.


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