On December 15, the company announced that a series of intervertebral fusion device products manufactured with metal additive manufacturing have obtained US FDA510 (K) certification. The series products have obtained sales qualifications in high-end markets in Europe and the US. The company's overseas product line layout has been further expanded, and its international competitiveness is expected to improve and maintain purchasing ratings.
Key points to support ratings
The company continues to expand its overseas layout and explore the unique advantages of international competitiveness. On December 15, the company issued an announcement stating that the metal additive manufacturing intervertebral fusion device series products have been certified by the FDA 510 (K), indicating that the company's financial additive manufacturing technology has been recognized internationally, and that related products are eligible for sales in high-end orthopedic markets in Europe and the US. In October of the same year, the company's Zeus spinal system products were certified by the US FDA 510 (K). All spinal stapler systems developed so far have obtained EU Medical Device Regulation (MDR) CE certification. In December of the same year, the company subscribed to Implanet's publicly traded shares, and the shareholding ratio increased to about 78.48%-85.42%. The company has independent R&D capabilities and a complete quality system. It is expected to stand out in the international high-end orthopedic market, export innovative therapy technology and products developed independently to overseas markets, continuously expand overseas layout, further enrich the overseas product line, and enhance the company's international competitiveness and comprehensive strength.
Metal additive manufacturing intervertebral fusion devices have excellent biomechanical properties and can effectively improve treatment results. In August 2023, the company's 3D printed “metal additive manufacturing intervertebral fusion device” was registered and approved by the State Drug Administration. Metal additive manufacturing intervertebral fusion devices are designed and developed on the basis of porous bone growth theory. They are used in conjunction with spinal internal fixation products and have good anatomical stent function. Indications include degenerative disc disease and spondylolisthesis. The series of products are manufactured through additive manufacturing processes and are composed of a porous structure and a support frame. At the same time, the porous structure of bionic trabeculae can better achieve bone fusion effects. Furthermore, the additive manufacturing process can achieve a high degree of customization of intervertebral fusion devices and can quickly respond to clinical needs, helping doctors further improve treatment effectiveness.
Innovative growth points have gradually entered the implementation stage, compounding the influence of collection, and the company is optimistic about the long-term development of the company. In addition to strengthening R&D and innovation in the traditional field of orthopedic implant consumables, the company has actively broadened its product line, maintained its innovative vitality and momentum, deployed active surgical equipment such as ultrasonic bone scisels and ultrasonic hemostatic knives, and obtained general agency rights for artificial bone in China, and actively expanded the field of sports medicine, further expanding the company's product line layout. Furthermore, the orthopedic industry collection has already been implemented, and the company has the ability to innovate treatments that are rare in the spine field. It is expected that it will fully enjoy the acceleration of the industry brought about by quantitative price compensation, and long-term development can be expected.
valuations
The company's net profit for 2023-2025 is expected to be 101 million yuan, 203 million yuan, and 261 million yuan respectively, and EPS of 0.41 yuan, 0.82 yuan and 1.05 yuan respectively. The PE corresponding to the current stock price is 45.8 times, 22.7 times, and 17.7 times, maintaining the buying rating.
The main risks faced by ratings
The risk of policy changes, the risk of downstream channel expansion falling short of expectations, the risk of product sales in the international market may fall short of expectations, and the risk of exchange rate fluctuations.