HONG KONG, Apr 3, 2023 – (ACN Newswire) – Peijia Medical Limited ("Peijia Medical" or the "Company", together with its subsidiaries, the "Group", stock code: 9996), a leading domestic player in the high-growth transcatheter valve therapeutic and neurointerventional procedural medical device markets in China, announced its audited consolidated annual results for the year ended 31 December 2022 (the "Year").
During the Year, the Group realized revenue of RMB250.8 million, an increase of 83.7% over the same period in 2021. The increase in revenue was mainly attributable to: 1) the commercialization of the second generation retrievable TAVR product, TaurusElite and 2) the steady increase in sales volume of existing neurointerventional products, including Tethys Intermediate catheter, SacSpeed Balloon Dilatation Catheter and Jasper SS Detachable Coil. Additionally, as a result of the Group's continuous efforts in cost control, gross profit margin remaine stable at 70.2%, representing an improvement of 0.1% over the same period in 2021. The Group's net loss narrowed significantly by 29.0% to RMB407.8 million from RMB574.2 million in the same period in 2021.
Transcatheter Valve Therapeutic Business: Market share increased significantly; the commercial team began to scale
Peijia's commercialization efforts in the Transcatheter Valve Therapeutic Business advanced significantly, benefiting from professional market education and promotion and outstanding product performance despite the impact from COVID-19 on the volume of the TAVR procedures over the market. During the Year, revenue generated from the sales of Transcatheter Valve Therapeutic products amounted to RMB107.3 million, representing a year-over-year increase of 155.9%. After the initial year of commercialization in 2021, the number of hospital admissions and end-user implants continued to increase significantly in 2022. During the Year, the Group's first- and second-generation transcatheter aortic valve systems TaurusOne and TaurusElite were newly placed in 195 hospitals. As of December 31, 2022, a total of 290 hospitals have used TaurusOne and/or TaurusElite. During the Year, the number of end-use implants reached 1,200+, representing a market share of about 14%. The increase of about 10 percentage points over the same period of the previous year meets performance guidance of capturing 12-15% market share.
The strong commercialization results are due to the Group's efficient and professional marketing and sales teams. As of December 31, 2022, the Group's Transcatheter Valve Therapeutic Business' sales and marketing team has grown to 185 employees, with the commercialization team beginning to scale among the industry players.
Neurointerventional Business: Steady revenue growth, commercialization of 4 new ischemic products, further diversification of revenue
During the Year, the Group continued to consolidate its first-mover advantage in Neurointerventional Business by consistently increasing product coverage, adoption, and expanded market share. The Group recorded revenue of RMB143.5 million, an increase of 51.7% over the same period of the previous year, indicative of Peijia's commitment to performance growth. During the Year, the Group's registration applications for 4 ischemic products; Fastunnel Delivery Balloon Dilatation Catheter which combines balloon and microcatheter in one device, Syphonet Stent Retriever, Tethys AS Aspiration Catheter and Fluxcap Balloon Guide Catheter, were approved by the National Medical Products Administration of the PRC (NMPA). With the approval of these 4 products, the Group successfully established its product portfolio for the ischemic product line with all major devices readily in place. As of December 31, 2022, the Group's Neurointerventional Business has 14 commercialized products and 7 products at different research and development stages, which comprehensively cover the inverventional treatment solution of hemorrhagic stroke, acute ischemic stroke, and intracranial atherosclerotic disease. The development of Syphonet Stent Retriever also leads to the development of BASIS (Balloon AngioplaSty with the distal protection of Stent retriever) technology. This innovative technology, with Syphonet Stent Retriever as the core and the combination of balloon dilatation catheter and intermediate catheter, provides a safe and effective treatment option for patients with ICAS-LVO type of stroke. As of the date of the annul results announcement, 4 new products had been launched and were expected to contribute to revenue growth in the next fiscal year.
The ongoing development of the ischemic product line, coupled with the first mover advantage of its hemorrhagic product line, enables the Group to further diversify its revenue composition for the Neurointerventional Business. Revenue generated from hemorrhagic products, ischemic products and vascular access products accounted for 39.4%, 27.6% and 32.9% of the revenue from the Neurointerventional Business (2021: 54.2%, 20.6% and 24.9%) respectively. As of December 31, 2022, the Group's Neurointerventional Business had a sales and marketing team of 77 employees, and 205 distributors, covering around 2,000 hospitals in [31] provinces nationwide. The Group's well-established commercialization team and dealer network will contribute to increasing the market share of Neurointerventional products.
R&D: Developed a comprehensive and in-depth product portfolio; consecutive market entrance of multiple blockbuster products
As a pioneer in the industry, the Group has developed a strategy with a comprehensive and in-depth pipeline of the next-generation core technology for Valve Therapeutic through internal development and external business development that comprehensively covers AS, AR, MR, TR, via transcatheter approaches. Additionally, the Transcatheter Valve Therapeutic Business' main pipeline products have successively progressed to the human trial stage. As of December 31, 2022, the Group's Transcatheter Valve Business had launched 5 products and is developing an additional 9 products, covering cutting-edge solutions such as AR indication valve, durability-enhanced valve, polymeric valve and non-impant therapy.
During the Year, in addition to actively promoting the multi-center registration clinical trial of Third-Generation Non-glutaraldehyde Crosslinked Dry-tissue TAVR System TaurusNXT and FIM clinical trial of the interventional non-implantable Lithotripsy Valvuloplasty System TaurusWave, the Group successfully carried out the multi-center registration clinical trial for HighLife TSMVR System and GeminiOne TEER System. Additionally, in partnership with inQB8 Medical Technologies, LLC, the Group completed the first human plant of the FIM clinical trial of MonarQTM Transcatheter Tricuspid Valve Replacement (TTVR) system in Coapenhagen, Demnark.
In December 2021, the Group entered into a series of agreements with JenaValve Technology Inc., for the exclusive right of Trilogy(TM) Heart Valve System in the Greater China region (named TaurusTrio(TM) by Peijia). So far, the Trilogy(TM) Heart Valve System is the first and the only TAVR device of its kind to receive CE Mark, making it the only TAVR product with dual indications for AR and AS in the world. During the Year, the Group successfully facilitated the technology transfer of the project. As of the date of the annual results announcement, the Group is preparing for the commercial impant in Hong Kong and the registration clinical trials in the mainland China.
As of December 31, 2022, the Group had an internal research and development team of 133 employees, who focus on the R&D, and clinical registration of transcatheter valve therapeutic products and Neurointerventional products. The Group has a strong intellectual property portfolio, including a total of 101 granted and valid patents (transcatheter valve therapeutic business: 63; neurointerventional business: 38) and 126 patents under application (transcatheter valve therapeutic business:105; neurointerventional business:21).
International strategy: Formulating a differentiated product overseas strategy – MonarQTM overseas clinical first to expand internationally
"Based in China, Looking at the world" has been Peijia Medical's mission since it was established as a leading innovative medical device company. Facing fierce competition and market challenges in Europe and America, Peijia management is focusing on product innovation and increasing the number of internal patents as its core strategy to compete internationally. Additionally, the Group actively markets its innovative, proprietary pipelines, strives to achieve key technological breakthroughs, and customizes overseas strategy for its different products, such as overseas clinical practice, and out-license. At present, many of the Group's transcatheter valve therapeutic products have the strength to go overseas, including the technologically innovative TaurusNXT (Non-glutaraldehyde Crosslinked Dry-tissue TAVR system), TaurusWave (Lithotripsy Valvuloplasty system), TaurusApex (Polymer Leaflets TAVR system), MonarQTM (TTVR system) and GeminiOne (TEER system) with independent patent (Freedom-to-Operate). The overseas expansion for the MonarQTM during the year is the first step in Peijia Medical's overseas strategy. The Group owns the global rights to the product and will continue to promote its overseas clinical practice as it looks to expand in the future.
"Peijia Medical will always uphold its corporate vision as we bolster our commitment to the development and commercialization of interventional solutions for structural heart and neurovascular diseases in China and globally. With the completion and commissioning of the new headquarters in 2023, Peijia Medical will fully accelerate its product development, production and commercialization. In the future, the Group will deepen its professional marketing network to further expand its business in transcatheter valve therapeutic products and grow its neurointerventional market share, while strengthening in-house R&D capabilities, international patent portfolios, as it further advances its globalization strategy," said Dr. Yi Zhang, Executive Director, Chairman of the Board, and Chief Executive Officer of Peijia Medical Limited.
About Peijia Medical Limited
Peijia Medical, headquartered in Suzhou, Jiangsu Province, China, was established in 2012 and listed on the Main Board of the Hong Kong Stock Exchange in May 2020 (Stock Code: 9996. HK). Adhering to the corporate vision of "Dedication with Passion, Devotion for Life", always put life and safety first, cultivate technology deeply, persist in innovation, and do as much as it can for helping life and health. With the strategic layout of "Innovation-oriented, Simultaneous Treatment of Heart and Cerebrovascular Diseases" and focusing on the innovation, R&D and production of high-end medical devices for structural heart and cerebrovascular disease intervention, Peijia Medical covers the entire product pipeline for aortic, mitral and tricuspid valve replacements and surgical instruments and accessories, as well as diseases related to hemorrhagic, ischemic and vascular access in the field of neurointervention, built a relatively comprehensive product portfolio and solutions in the field of structural heart and neurovascular diseases in China.
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