Shenzhen, March 28, 2024 /PRNewswire/ -- On March 28, 2024, Xianjian Technology (“the Company” or “Xianjian Technology”, stock code: 1302.HK) and its subsidiaries (collectively, the “Group”) announced the audited comprehensive results for the year ended 31 December 2023 (the “reporting period”):

• Strong international business growth:The Group achieved sales revenue of approximately RMB 1,267.2 million, an increase of about 15.5% year on year. Among them, sales in overseas markets increased significantly by about 36.0% year on year, and in particular, the European market grew strongly by about 52.9%;
• Stable profitability:The Group achieved gross profit of approximately RMB 995.6 million, an increase of about 13.9% over the previous year; the gross margin performance was stable at about 78.6%. Exclude a number of non-recurring items^[1]The net profit to mother was approximately RMB 423.3 million, and the net profit margin to mother was about 33.4%;
• Abundant cash flow:As of December 31, 2023, the Group held approximately RMB 979.3 million in cash and cash equivalents, an increase of approximately 17.5% over the previous year. This increase was mainly due to increased cash flow from operating activities. Adequate cash flow lays a solid foundation for the Group's long-term development.

Note: [1] The above non-recurrent items include: 1) Due to the sharp increase in the valuation of Series B financing of Yuanxin Technology (Shenzhen) Co., Ltd., the corresponding sharp increase in the fair value of its redeemable shares. The loss due to changes in the fair value of financial liabilities recorded as profit and loss in 2023 was approximately RMB 213.8 million; 2) Other income and losses from financial assets that include profit and loss at fair value. The revenue in 2023 was approximately RMB 34.0 million; 3) share-based payment expenses totaling approximately RMB 112.8 million in 2023.

International businessStrong growth Mainland businessSteady operation

In 2023, the Group faced multiple challenges and continued to focus on unmet global clinical treatment needs. Under the leadership of an “innovative” and “international” two-wheel drive development strategy, innovation continued to empower the Group's further development in the international market. During the reporting period, the Group connected the world with a rich innovative product portfolio and high-quality academic services, and successfully expanded sales channels to nearly 120 countries and regions around the world under the collaborative development of experiences and advantages in brands, patents, channels, clinical registration, and global operation management. The penetration rate of products in overseas markets continued to deepen, and recorded a significant year-on-year increase in overseas sales of about 36.0%. In particular, the European market grew strongly by about 52.9% on a high base. With the effective advancement of the internationalization strategy, the Group's international business development continued to accelerate, and sales contributions from overseas markets rose to about 21.7% of the Group's total revenue during the reporting period. Among them, Asia (excluding mainland China) and Europe are the Group's two largest overseas markets, and the share of sales in the reporting period jumped to about 9.0% and 8.8% of the Group's total revenue.

The mainland China market is the foundation for the Group's development and is currently the Group's largest market. The Group continues to advance its core development strategy in the mainland China market, actively explore and adopt more stable and sustainable business development strategies in accordance with changes in the domestic industry, and continuously accelerate the clinical and marketing process of new products in the mainland China market. During the reporting period, sales recorded an increase of about 10.8% over the same period last year, accounting for about 78.3% of the Group's total revenue. The Group's range of products for congenital heart disease occlusors, left atrial occlusers, aortic laminating stents and venous venous filters has a rich level of innovation and iteration, penetrating the mainland grass-roots market, and has maintained leading market share in mainland China for many years.

Steady growth in core business Continuously demonstrate development resilience

NO.1Structural heart disease business:

The products provided by the Group's structural heart disease business mainly include left atrial occlusion devices and congenital heart disease obstructors. During the reporting period, sales revenue was approximately RMB 495.7 million, an increase of about 25.6% over the same period last year. Among them, revenue from sales of left atrial occlusions increased by about 32.0% year on year, and the innovative product steadily ranked first in the global market share of domestic brands; revenue from sales of congenital heart disease obstructors increased by about 23.1% year on year, mainly due to the Group meeting different market needs through differentiated product strategies in the global market. The Group diversifies its structural cardiology business product portfolio and continues to meet growing treatment needs through continuous technological innovation and product upgrades, thereby further deepening its sales layout in the global market.

NO.2 Peripheral vascular disease business:

The Group is committed to providing patients at home and abroad with technology-leading systemic comprehensive interventional treatment solutions for peripheral vascular diseases. The main products include thoracic aortic stents, abdominal aortic stents, iliac artery bifurcation stents, and venous venous filters. During the reporting period, the Group's peripheral vascular disease business revenue was approximately RMB 707.1 million, an increase of about 9.7% over the previous year. Among them, revenue from sales of laminated stents increased by about 11.2% compared to the same period last year, and revenue from sales of venous venous filters decreased by about 1.0% compared to the same period last year. The above two series of products have maintained a leading position in the mainland China market for many years. The Group's peripheral vascular disease business products under development and clinical registration can effectively collaborate with existing products to provide patients with overall solutions, and will fill many gaps in clinical treatment, which will give the Group's peripheral vascular disease business strong and long-lasting competitiveness in the global market.

NO.3Pacing electrophysiology business:

The Group is the first domestic manufacturer with a complete product portfolio of implantable pacemakers with world-class technology and functionality. During the reporting period, the Group recorded sales revenue of approximately RMB 64.4 million, an increase of about 10.3% over the previous year. The Group's domestic brand MRI-compatible pacemaker project is progressing in an orderly manner, which will further enrich the product portfolio of the Group's pacemaker electrophysiology business.

Innovate to accumulate energy and continue to develop

Self-developed innovative medical device products can not only save energy for the Group's sustainable development, but also provide the Group with long-term market competitiveness. The Group is currently rich in research and clinical pipelines, all of which have extremely high innovation content and broad market prospects. This enables us to overcome future challenges and provide better disease treatment solutions to patients around the world. In 2023, the Group's R&D investment was approximately RMB 297.9 million, an increase of about 42.9% over the same period last year to continuously strengthen the Group's technological innovation capabilities and accelerate the development and commercialization of new products.

Product commercialization progresses in an orderly manner

• AcuMark atrial septal defect measurement balloon, peripheral thrombus suction catheter, and Epione puncture navigation and positioning system were approved for marketing by the National Drug Administration (NMPA);
• The Aegisy venous venous filter, AcuMark atrial septal defect measurement balloon, ZoeTrack guide wire, SeQure luminal capture system, and CERA vascular plug system were successfully converted and approved by CE MDR (EU Medical Device Regulation) certification;
• The Ankura Chimney aortic laminating stent system (including the Ankura Pro aortic main laminating stent system and Longuette aortic branch laminating stent system), Futhrough aortic laminating stent rupture system, FemFlow drug-eluting peripheral balloon catheter, CeraFlex unthreaded ceramic membrane atrial septal defect blocker, distal channel catheter kit, disposable negative pressure suction pump, intracranial thrombus suction catheter and DiAcu disposable endoscopic ultrasound suction biopsy needle are being registered and approved in China;
• The Ankura IIC aortic laminating stent system and the Ankura Chimney aortic laminating stent system (including the Ankura Pro aortic main laminating stent system and the Longuette aortic branch laminating stent system) are undergoing CE certification in the EU;
• Thoracoabdominal aortic stent systems (including G-Branch thoracoabdominal aortic stent system, SilverFlow PV peripheral vascular stent system, and aortic extended stent system) and aortic arch stent systems (including Ankura Plus aortic arch main stent system and CSKirt aortic branch stent system) have completed pre-marketing clinical enrollment in China and are currently undergoing clinical follow-up;
• The CS aortic arch partial branch reconstruction system, the X-Clip transcatheter mitral valve clip system, and the X-Clip controllable guidance system have successfully completed the first clinical study of human implantation (FIM) in China;
• The Cera ceramic membrane oval hole unclosed occluder and the Cinenses pulmonary volume reduction and recirculation ring system are currently in the pre-registration clinical phase in China.

Iron-based absorbable material platform: capital helps rapid development

In September 2023, the subsidiary Yuanxin Technology (Shenzhen) Co., Ltd. (hereinafter referred to as “Yuanxin Technology”) successfully completed Series B strategic financing of more than 200 million yuan. Series B financing brought in many strategic investors such as Gongqingcheng Huayi and Guangfa Qianhe. Round A investors such as IDG and Shanghai Baoquan continued to invest, leading to a sharp increase of 173% in post-investment valuations.

Yuanxin Technology focuses on the research, development, manufacture and sales of medical bioabsorbable metal material products. The iron-based bioabsorbable materials independently developed by the company and pioneered in the world have a wide range of application space and expansion potential in the medical field. The first batch of three products targets the treatment of coronary artery stenosis, submandibular artery stenosis, and pulmonary artery stenosis. The market capacity is huge or clinical needs need to be met urgently, and they have broad market prospects. With the help of capital, clinical and marketing approval of these three innovative products progressed in an orderly manner during the reporting period, and the clinical data advantages of the products were obvious.

• The IBS absorbable drug-eluting coronary stent system has successfully completed a five-year FIM clinical study. Phase II and phase III clinical trials are also being followed up, and an application for EU CE registration has been submitted. The innovative product has been implanted in more than 1,100 cases in phase III clinical trials. The success rate of surgery is 100%, and the target blood vessel failure rate and thrombus incidence rate are in line with expectations, all at a low level.
• Clinical registration of the IBS Titan absorbable drug-eluting peripheral stent system is progressing steadily. The first clinical enrollment has been successfully completed in Europe and an application for EU CE registration has been submitted. The product has been approved by the US FDA for “sympathetic use” and has been successfully implanted.
• The world's only iron-based absorbable stent for children - the IBS Angel iron-based absorbable stent system has obtained Malaysian registration and EU CE MDR certification, and has also passed FDA “sympathetic use” approval for implantation in many cases in the US.

Capital assistance will further accelerate the clinical and marketing process of revolutionary innovative products on the Group's iron-based bioabsorbable materials platform, thereby bringing unprecedented, safe and effective treatment methods to patients around the world as soon as possible, and will effectively promote Yuanxin Technology to independently carry out subsequent capitalization operations, thereby enhancing the Group's overall value.

Intellectual property protection

The Group continues to attach importance to high-quality global intellectual property layout. As of December 31, 2023, it has submitted 2,147 valid patent applications, of which 942 valid patents have been approved. Through continuous intellectual property innovation, application, protection and management, the Group has established leading technological innovation capabilities, forward-looking patent layout and a perfect intellectual property protection system.

The ability to innovate is highly recognized by the industry

• “DiaCu disposable endoscopic ultrasonic suction biopsy needle” product industrial design won the German Red Dot Award;
• The “Innovation and Promotion and Application of Key Technology Systems for Interventional Structural Heart Disease Diagnosis and Treatment” project won the first prize of the Beijing Technological Invention Award;
• “Construction and application of a total aortic intravenous diagnosis and treatment system” won the second prize of the Beijing Science and Technology Progress Award;
• “LamBrE left atrial occluder system” won the top ten independent innovative medical device products in 2023.

Mr. Xie Yuehui, Chairman of the Board of Directors and CEO of Xianjian Technology, said:

“Despite facing multiple challenges in 2023, we are making steady progress in R&D innovation, global channel expansion, and product sales. Driven by the two-way development strategy of 'innovation' and 'internationalization', Xianjian Technology has penetrated the global intellectual property dense with original research and innovative products, covering nearly 120 countries and regions around the world, keeping our business ahead of the domestic industry in terms of internationalization. We believe that the long-term benefits of innovation will enable the company to face future challenges, provide sustainable momentum for breakthrough development, and provide a solid guarantee for our continuous expansion into the international market.

In the future, we will continue to use innovation to stimulate our strong business vitality and development potential in the global market. Promote the rapid development of existing business in the global market with a prudent and pragmatic attitude, strict and efficient management, and a solid and stable business core. At the same time, we will also actively seek and seize new development opportunities, integrate and strengthen superior internal and external resources, and enhance the Group's overall value in multiple dimensions, so as to achieve our development goals in the global healthcare field as soon as possible.”

About Xianjian Technology:

Xianjian Technology Co., Ltd. (stock code: 1302.HK) is an industry-leading cardiovascular and peripheral vascular interventional medical device company. It was founded in 1999 in Shenzhen, China. It is a national high-tech enterprise and the third batch of specialized and innovative “little giant” enterprises of the Ministry of Industry and Information Technology. The company's products under research and sale cover structural heart disease, peripheral vascular disease, pacing electrophysiology, respiratory intervention, neurological intervention, tumor intervention, etc., and has the world's first iron-based bioabsorbable material platform, which has achieved independent innovation and technological breakthroughs in various segments. As of December 31, 2023, the company has achieved 2,147 high-quality patent layouts. Currently, a total of 15 products have been approved by the National Drug Administration (NMPA) to enter the “Special Examination Procedure for Innovative Medical Devices”. Adhering to the “innovation” and “internationalization” development strategy, the company has long been in a leading position in the domestic market share of its main products, and has subsidiaries and offices in 6 countries around the world. The sales network covers nearly 120 countries and regions around the world. It is one of the few domestic interventional medical device companies with highly international business.