Incident: Recently, the company released its semi-annual report for 2023, achieving operating income of 50 million yuan, gross profit of 20 million yuan, and losses attributable to equity shareholders of the Company of 540 million yuan.
Surgical robots have entered a new cycle of dosage. The company Tumai Robot continues to take advantage of its leading edge in the industry and has completed the installation and sale of multiple products. The flagship product Dragonfly Eye has achieved a steady increase in revenue with a good commercialization foundation.
Currently, the company's surgical robot products that have been approved for marketing by NMPA include Tumai and Honghu, which obtained licenses in January and April 2022, respectively. Among them, Honghu also obtained 510 (k) certification from the FDA in July 2022, completed its first commercial installation, and contributed overseas revenue for the first time. The increase in losses in 2023 compared to the same period last year was mainly due to 1) a sharp increase in sales expenses, which increased staff costs for the product commercialization team; 2) the same period last year was under epidemic control, and many activities and corresponding expenses were delayed until the second half of the year.
Endoscopic surgery robot: As the core product, Tumai benchmarks Leonardo da Vinci, and 2022 will begin the first year of localization. The company Tumai was approved for listing by the NMPA on January 27, 2022 (used in urology). It is the first and only four-arm endoscopic surgery robot independently developed and marketed by a Chinese company in China. Judging from clinical data, its effectiveness is not inferior to Leonardo da Vinci Si. At the same time, the Tumido subject and multi-center registered clinical trial began enrollment in October 2021, covering various fields such as general surgery, thoracic medicine, and gynecology. Clinical trials were completed in April 2022. Currently, it is in the NMPA registration application, and H2 is expected to be approved in 2023. In 2023, H1, Tumai has completed installation inspection at four hospitals in China, and completed 1,200 robot-assisted clinical verification surgeries in more than 40 hospitals in more than 20 provinces across the country. Of these, 23H1 surgeries exceeded 500.
Orthopedic surgery robot: Honghu has been approved for listing by both the NMPA and FDA, leading the country in progress. In April 2022, the company Honghu Applied to TKA Surgery was approved for listing by NMPA, making it currently the first and only orthopedic surgery robot equipped with independent research and development, its own intellectual property rights, and marketed domestically.
It received 510 (K) certification from the FDA in July 2022 and CE certification in December 2022. Becoming the only Chinese surgical robot currently listed in the US, China, Europe and the US is a key milestone in the company's globalization strategy. At present, Honghu has won bids and installed multiple units at home and abroad. Furthermore, registered clinical trials for THA and UKA indications of the Honghu joint robot will soon be launched, leading the country in progress.
Endogeny+epitaxial, alternate products comprehensively lay out other surgical robot racetracks. The company's pan-vascular field became the first tier in China through the “self-developed TAVR surgical robot+introduction of R-ONE vascular interventional surgery robot”. Among them, R-ONE has completed all registered clinical trials in China and is expected to be approved for listing in 2023; through the natural cavity field, it became a domestic leader through the “self-developed transbronchoscopic surgery robot”, completed the first human clinical trial in March 2022, and is about to begin registration for clinical trials; the field of percutaneous puncture has passed the “introduction of ISR'obot? The “Mona LiSA robot+automatic needle targeting robot system ANT” layout. The former has submitted an NMPA registration application and has already been approved for listing.
Profit forecast: Revenue from 2023 to 2025 is expected to be 190 million, 7.6 billion yuan, and 1.87 billion yuan respectively. Currently, it is in its infancy, and expansion is imminent.
Risk warning: Product development and marketing progress or risk falling short of expectations, risk of Tumai's post-listing volume falling short of expectations, policy fee control risk.