Event: the company recently released its mid-term results for 2022, with an income of 1.048 million yuan and a gross profit of 690000 yuan in the first half of the year. The company's equity shareholders should share a loss of 460 million yuan.
With the launch and commercialization of blockbuster products, surgical robot products are expected to contribute to revenue growth. 22H1 mainly contributes revenue from dragonfly. Currently, surgical robot products approved by NMPA include Toumai and Swan, which were licensed in January and April 2022, respectively. Swan also received FDA's 510 (k) certification in July 2022, and surgical robot products are expected to contribute a major part of revenue in the second half of 2022. The increase in 22H1 losses is mainly due to 1) increased investment in product research and development, clinical trials and product registration; 2) increased sales and marketing expenses due to the commercialization of surgical robots; 3) increased number of employees as a result of R & D progress and commercial layout, and staff costs including share payments increased.
Endoscopic surgery robot: Tumai, as the core product of Leonardo da Vinci, started the first year of localization in 2022. Tumai, which was approved by NMPA on January 27, 2022, is the first and only four-arm endoscopic surgery robot independently developed and listed by Chinese enterprises. from the clinical data, it is as effective as Leonardo da Vinci Si. At the same time, Tumai multi-disciplinary, multi-center registered clinical trial started in October 2021, covering general surgery, chest, gynecology and other fields, and completed the clinical trial in April 2022. It is currently in the process of applying for NMPA registration and is expected to be approved in the first half of 2023. Even affected by the epidemic, 22H1 still has nearly 10 new Tumai clinical application and training centers in China, and is expected to make a large number of commercial sales in 2023. In addition, in the first half of the year, Tumai completed dozens of exploratory clinical trials of single-arm endoscopic surgery robots, and clinical preparations for registration are progressing in an orderly manner.
Orthopaedic surgery robot: Swan has been approved for listing in NMPA and FDA, leading the way in China. In April 2022, the company's swan was approved for listing by NMPA in TKA surgery, becoming the first and only orthopedic surgery robot equipped with independent research and development, its own intellectual property rights and listed in China.
FDA 510 (K) certification in July 2022, becoming the first and only Chinese surgical robot to be certified by FDA, is a key milestone in the company's globalization strategy. An application for CE certification is also submitted in March 2022 and is expected to be listed in the first half of 2023. In addition, the clinical registration of swan joint robot THA and UKA indications will be carried out soon, and the progress is leading in China.
Endogenesis + epitaxy, alternate products overall layout of other surgical robot tracks. The pan-vascular field of the company has become the first echelon in China through "self-developed TAVR surgery robot + introduction of R-ONE vascular interventional surgery robot". Among them, R-ONE has completed all the registered clinical trials in China and is expected to be approved for listing in 2023. Through the "self-developed bronchoscopic surgery robot" in the natural cavity field, the first human clinical trial was completed in March 2022, and the registered clinical trial is expected to be carried out in the second half of 2022; in the percutaneous puncture field, through the layout of "introduction of iSR'obotMona Lisa robot + automatic needle aiming robot system ANT", the former has completed China's registered clinical trials and is expected to be approved for listing in 2023.
Profit forecast: it is estimated that the income of 2022-2024 is 0.9,5.1 and 1.23 billion yuan respectively, which is in the initial stage and the volume is just around the corner.
Risk hints: the risk that the progress of product research and development and listing is not as expected, the risk that the volume of Tumai is not as expected after listing, and the risk of policy fee control.