Results Highlights:

- Revenue reached US$83.6 million, a year-on-year increase of 5.9%.
- Sales volume reached 919,000 units, of which 779,000 units were proprietary products, representing a year-on-year increase of 8.6%.
- Profit attributable to owners of the company increased by 5.1% year-on-year to US$19.8 million.
- Core operating profit amounted to US$15.1 million, an increase of 11.4% year-on-year.
- The Board declared a special dividend of HK15 cents per share to mark the Group’s 25th anniversary.
- The Group maintained a sound financial position with cash and bank balances of US$237.1 million as of June 30, 2025 to support potential acquisitions and the construction of new manufacturing facilities.
- The Group’s high-quality products have gained widespread recognition worldwide, resulting in revenue growth of 14.0% in the APAC market, 17.0% in the EMEA market, and 20.0% in the US market.
- The Group acquired a Taiwan-based distributor in the first half of the year. It also plans to establish direct sales teams in Belgium and the Netherlands in the second half of the year, further strengthening direct presence in APAC and EMEA markets.
- Leveraging its global commercialization expertise and extensive distribution network, the Group established strategic partnerships with medical device peers, thereby diversifying its product portfolio and generating additional revenue through cross-selling opportunities.

HONG KONG, Aug 15, 2025 - (ACN Newswire) - OrbusNeich Medical Group Holdings Limited (“OrbusNeich” or the “Group”; stock code: 6929), a multinational medical device company specializing in interventional devices for percutaneous coronary intervention (“PCI”) and percutaneous transluminal angioplasty (“PTA”) procedures, today announced its interim results for the six months ended June 30, 2025 (the “Period”), reporting growth in both revenue and net profit despite an uncertain macroeconomic landscape.

The Group recorded revenue of US$83.6 million, up 5.9% over the previous year, driven by strong year-on-year growth in the US market, as well as continued contributions from emerging markets in APAC and EMEA. Core operating profit, being profit attributable to the owners of the Company excluding share-based compensation, net tax credit from deferred tax asset in relation to tax losses, and finance income/costs, amounted to US$15.1 million, up by 11.4% year-on-year. Profit attributable to the owners of the Company increased by 5.1% year-on-year to US$19.8 million. Basic earnings per share was US2.40 cents (first half of 2024: US2.28 cents).

As of June 30, 2025, the Group maintained a strong financial position with cash and bank balances amounting to US$237.1 million. In light of the Group’s solid financial position and in celebration of the its 25th anniversary, the Board has resolved to declare a special dividend of HK15 cents per ordinary share, demonstrating the Group’s commitment to creating value for its Shareholders. Together with the final dividend of HK10 cents per share for the year ended December 31, 2024 paid on June 16, 2025, Shareholders will receive a total dividend of HK25 cents in 2025.

Mr. David Chien, Chairman, Executive Director and Chief Executive Officer of OrbusNeich, said, “Over the past 25 years, we have continuously invested in innovation and global commercial capabilities, establishing OrbusNeich’s reputation and enabling us to navigate different economic cycles. Despite macroeconomic and geopolitical challenges in the first half of 2025, our global deployment proved resilient. Growth in the US market reflected strong demand for our high-quality products, while our extensive sales network successfully captured growth opportunities in the APAC and EMEA regions. We will continue to sharpen our competitive edge by enhancing brand value through our direct sales market presence, excellent sales support, commitment to innovation, and comprehensive PCI and PTA product portfolio, while advancing safer, more effective solutions for physicians and patients and delivering long-term returns to shareholders.”

Global Sales Network and Partnerships Boost Revenue Growth
OrbusNeich has built a sales network spanning over 70 countries and regions, including direct teams in 13 locations and a global distributor network, which proven integral to capturing local opportunities and demand worldwide. APAC revenue rose by 14.0% year-on-year to US$27.3 million during the Period, fueled by growth in Indonesia and increasing adoption of Scoreflex TRIO in Singapore and Malaysia. EMEA revenue grew 17.0% to US$22.4 million, driven by strong proprietary balloon product sales in key direct markets (Germany, France, Spain) and distributor markets (the UK, Slovakia, Czech Republic). Despite tariff disruptions, US revenue increased by 20.0% to US$8.0 million, boosted by a notable surge in sales volume of standard and scoring coronary balloons and peripheral balloons, including the high-priced Scoreflex NC balloon. Revenue from the Japan and PRC markets was US$16.1 million and US$9.7 million, respectively.

Leveraging its widely-recognized global commercialization expertise, the Group partnered with peers pursuing international expansion to enrich its product portfolio and drive additional revenue streams. Building on the successful collaboration with SonoScape Medical Corp. involving the distribution of intravascular ultrasound (“IVUS”) products in Hong Kong and Macau last year, the Group has entered into a sole and exclusive distribution agreement with this partner to distribute its IVUS products in Singapore and Malaysia. The collaboration now covers four additional direct European markets (France, Germany, Spain, Switzerland) and six other distributor markets across Europe.

Performance-Led Innovation Fuels Market Distinction and Portfolio Diversity
As of June 30, 2025, OrbusNeich had obtained more than 250 granted patents and published patent applications in key jurisdictions worldwide, as well as over 55 approved products.

During the Period, the Group made progress in terms of product registrations and clinical trials, including:
- Sapphire 3’s US trial progressing smoothly, with patient enrollment set to finish in Q4 2025 to support FDA submission for the CTO indication, distinguishing it from other conventional semi-compliant balloons on the market;
- Obtained CE Marks for JADE PLUS and Teleport Glide, PMDA approvals for Teleport Glide and Scoreflex QUAD, FDA approvals for the COREPASS Modular Microcatheter, and NMPA approval for the guiding catheter;
- Submitted registration applications for Scoreflex TRIO, Sapphire ULTRA, Sapphire NC ULTRA, Sapphire NC 24, JADE PLUS, Teleport XT and Teleport Glide to the NMPA, and applications for the Vascuaid Aspiration Catheter and GCE Large Lumen to the PMDA.

Regarding the Group’s robust product pipeline, the Sapphire PTX paclitaxel drug-coated balloon, in the coronary space, is set to begin clinical trials in Japan near the end of 2025. In the peripheral space, the JADE Score balloon is expected to be submitted for PMDA approval in 2026.

The joint venture OrbusNeich P&F also made significant progress in the clinical trials of TricValve in the PRC, with the number of participating sites increased to accelerate patient enrollment. In addition, it has been actively promoting TricValve’s entry into hospitals in the Greater Bay Area (“GBA”) through the Hong Kong & Macau Registered Drugs and Medical Devices Access to GBA Program. The first commercial implantation of TricValve in the Mainland of China was completed in July 2025, marking the achievement of an important milestone.

Multi-Region Production Bases Mitigate Evolving Geopolitical Risks
As of June 30, 2025, OrbusNeich’s aggregate annual production capacity was approximately 2.1 million balloons and stents, with production facilities in Shenzhen, the PRC; Hoevelaken, the Netherlands; and Weil am Rhein, Germany. Since acquiring eucatech AG in late 2023, the Group has allocated resources to restore its production capabilities, gradually ramping up output during the Period to supply products for both sales and clinical registries.

The Group completed the main structure construction of its largest R&D and production facility in Hangzhou, the PRC, in August 2025, with renovation work expected to begin in the second half of the year. The facility is scheduled to commence operations in 2027, adding an annual production capacity of 2.4 million units.

Mr. Chien concluded, “We remain optimistic about the second half of 2025 due to strong momentum in emerging markets, successful proprietary product launches, and strategic partnerships. APAC and EMEA will remain our key growth drivers, with plans to transition selected markets from distributor to direct sales models to enhance revenue and market presence. In Europe, we will establish direct sales teams in Belgium and the Netherlands to expand our footprint. The Japanese market will see renewed momentum through new product launches, while in the PRC market, we will capitalize on policy support to expand product coverage and accelerate commercialization. US shipments are expected to speed up amid easing tariff disputes. Backed by OrbusNeich’s diversified portfolio, strong financial position, and economies of scale, we are well positioned to build a resilient, competitive business that delivers sustainable value to stakeholders.”

About OrbusNeich Medical Group Holdings Limited
OrbusNeich is a multinational medical device company specializing in interventional devices for percutaneous coronary intervention (PCI) and percutaneous transluminal angioplasty (PTA) procedures. Headquartered in Hong Kong, China, our Group sells its products in more than 70 countries and regions worldwide. It is also actively expanding into structural heart disease. With an in-house R&D team boasting over 20 years of product development expertise, our Group has developed world-leading proprietary technologies.

For more information, please visit the Group’s official website: https://orbusneich.com/.

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