Main points of investment
Event: the company recently issued a performance announcement for 2021, with an income of 2.15 million yuan and a gross profit of 920000 yuan in 2021, with a loss of 580 million yuan this year.
The main contribution to the income in 2021 is dragonfly. Currently, the company's products approved by NMPA include Dragonfly Eye and Tumai, which were licensed in June 2021 and January 2022, respectively. The main reasons for the higher losses in 2021 are: 1) increased investment in product research and development, clinical trials and product registration; 2) commercialization of surgical robots; 3) share awards for equity settlement to some employees; 4) listing fees.
Endoscopic surgery robot: Tumai, as the core product of Leonardo da Vinci, started the first year of localization in 2022.
The company Tumai completed a clinical trial in May 2021, which is as effective as Leonardo da Vinci Si, and was approved by NMPA on January 27, 2022. 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 in January 2022. Q1 is expected to be approved for listing by NMPA in 2023. The company plans to set up a wide range of training centers in 2022 and make large-scale commercial sales in 2023.
Orthopaedic surgery robot: Swan is in the registration stage in both NMPA and FDA, leading the way in China.
Swan is the only joint replacement robot independently developed by domestic enterprises and equipped with self-developed manipulators, has completed clinical trials of TKA surgery, and submitted a registration application to the FDA in July 2021, and is expected to be approved for listing in China in 2022, in addition, Swan is the first product in the company's globalization strategy to apply for overseas listing, and has submitted a 510K application to FDA in December 2021. 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 company's pan-vascular field has become the first echelon in China through the "self-developed TAVR surgery robot + the introduction of R-One vascular interventional surgery robot", and through the natural cavity field through "self-developed transbronchoscopic surgery robot", the company has become a domestic leader and completed the first human clinical trial in March 2022. Through the layout of "introduction of iSR'obot Mona Lisa robot + automatic needle aiming robot system ANT" in the field of percutaneous puncture, both of them completed the first clinical trial in November 2021.
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.