Results Highlights:
- Revenue hit record high of US$164.1 million, up 6.6% year-on-year.
- Sales volume reached 1.7 million units, of which 1.5 million units were proprietary products, showing an increase of 4.8% year-on-year.
- Gross profit increased by 7.5% to US$114.5 million, with gross profit margin improving to 69.8%; profit for the year attributable to owners of the Company was US$39.7 million.
- The Board proposed a final dividend of HK10 cents per share, representing a dividend payout ratio of 26.7%.
- The Group maintained a sound financial position with cash and bank balances of US$248.6 million at year-end to support merger and acquisition initiatives.
- Fueled by newly acquired distributors in Indonesia and South Korea, along with organic growth in direct sales, APAC market revenue grew 43.7% year-on-year, while the US and the PRC markets showed signs of recovery in the second half of 2024.
- The Group registered products of eucatech AG, a German company acquired in November 2023, in the Czech Republic, Italy, Malaysia, Saudi Arabia, Spain, Switzerland, UAE, and Vietnam.
HONG KONG, Mar 7, 2025 - (ACN Newswire) - OrbusNeich Medical Group Holdings Limited (“OrbusNeich” or the “Group”; stock code: 6929), a major global medical device manufacturer specializing in interventional devices for percutaneous coronary intervention (“PCI”) and percutaneous transluminal angioplasty (“PTA”) procedures, today announced its annual results for the year ended December 31, 2024 (the “Year”), reporting record-high revenue and healthy net profit despite the challenging business landscape.
Driven by the recovery of sales in the US and continued growth in the APAC market in the second half of the year, the Group’s revenue reached US$164.1 million, an increase of 6.6% over the previous year. Excluding the impact of foreign exchange, revenue growth would have been 8.7% year-on-year. Gross profit increased by 7.5% to US$114.5 million, and gross profit margin rose slightly to 69.8%. During the Year, the Group laid the groundwork for stronger long-term performance by integrating the businesses of the three companies acquired in late 2023. Although these integration efforts incurred temporary costs, resulting in a profit of US$39.7 million attributable to the owners of the Company (2023: US$45.1 million), they are expected to generate substantial synergies in the future. Excluding the abovementioned additional expenses, the three core operating expenses, namely selling and distribution expenses, general and administrative expenses and research and development expenses, were remained stable year-on-year.
As of December 31, 2024, the Group was in a strong financial position with cash and bank balances amounting to US$248.6 million (2023: US$255.8 million). After careful consideration of the Group’s future capital requirements, the Board has proposed a final cash dividend of HK10 cents per share (2023: HK10 cents per share) as a token of appreciation for the continued support from shareholders and investors.
Mr. David Chien, Chairman, Executive Director and Chief Executive Officer of OrbusNeich, said, “In 2024, the OrbusNeich team navigated challenges while diligently strengthening R&D, production, supply chain, clinical, regulatory, quality, sales, and marketing capabilities. The immediate contributions of our newly acquired distributors in Indonesia and South Korea bolstered our APAC market performance. Meanwhile, our focus on product registration for eucatech AG, has resulted in approvals in eight countries, with more on the horizon. As we celebrate OrbusNeich’s 25th anniversary in 2025, our relentless innovation, strong global presence and pioneering products will continue to propel us to new heights, as evidenced by our established global reputation and continued revenue growth over the past few years. Looking ahead, we remain committed to improving patient outcomes while striving to create long-term value for shareholders.”
Extensive Sales Network Fuels Growth in APAC and EMEA
OrbusNeich sold its products through its extensive sales network covering more than 70 countries and regions worldwide, and maintained a balanced revenue distribution across major markets. Driven by external growth from newly acquired distributors in Indonesia and South Korea, as well as robust organic growth from the markets in Malaysia, Singapore, Hong Kong, Vietnam, and India, the APAC market became the Group’s major growth driver during the Year, with revenue increasing by 43.7% to US$52.2 million. In particular, the latest generation of scoring balloon, Scoreflex TRIO, recorded rapid sales growth following its launch in Malaysia in early 2024. EMEA market revenue grew by 7.9% year-on-year to $39.2 million, mainly attributable to increased sales of the Group’s proprietary balloon products in direct sales markets such as Germany and Spain, as well as in distribution markets such as the Czech Republic, Slovakia, and the United Kingdom.
Both the PRC and the US markets achieved significant improvement in the second half of 2024. As the Beijing-Tianjin-Hebei “3+N” Alliance Volume-Based Procurement (“VBP”) was gradually rolled out in various provinces, the Group adopted a more proactive marketing strategy, which resulted in Scoreflex’s sales volume gaining momentum, facilitating an improvement in the performance of the PRC market in the second half of the year, reaching a revenue of US$20.7 million. Meanwhile, following active discussions with Abbott, the Group’s US distributor, revenue in the US gradually picked up. In particular, the sales volume of the high selling price product, Scoreflex NC, more than tripled in the second half of the year compared with the first half, driving the revenue of the US market to reach US$17.5 million. The Japan market recorded revenue of US34.4 million.
Diversity in Innovation with a Portfolio of Approved Products and Upcoming Clinical Trials
As of December 31, 2024, OrbusNeich had more than 240 granted patents and published patent applications worldwide in key jurisdictions and an aggregate of more than 50 approved products. During 2024, the Group made significant progress in terms of product registrations and clinical trials, including:
- Obtained NMPA approval for Teleport Neuro, FDA approval for Teleport XT, JADE PLUS 14/18/35 OTW, Sapphire Ultra and Sapphire NC Ultra, and CE Marks for Sapphire Ultra, Sapphire NC Ultra, Xtenza and Teleport XT;
- Submitted NMPA registration application for its guiding catheter and Jade PTA Line Extension, and PMDA registration application for Scoreflex QUAD and Teleport Glide;
- Completed clinical trial patient enrollment for Scoreflex TRIO in the PRC with NMPA application submission in January 2025;
- Initiated clinical trial patient enrollment for Sapphire 3 in the US in Q4 2024, with approval application expected to submitted in Q1 2026.
The Group has also been actively registering eucaLimus (DES), Support C (coronary DCB), and VITUS (peripheral DCB) in various countries following the acquisition of eucatech AG in late 2023. Registrations for one or more of the above-mentioned products were completed in the Czech Republic, Italy, Malaysia, Saudi
Arabia, Spain, Switzerland, the UAE, and Vietnam, while applications are pending approval in Hong Kong, Indonesia, and Singapore. Additionally, to renew the CE Mark for its products under the MDR regime, clinical registries have been initiated with renowned key opinion leader clinicians as lead principal investigators.
The Group continued to invest in new pipeline products such as the aspiration catheter, dual lumen catheter, peripheral scoring balloon and sheath, and registration of these products is expected to be submitted to various regulatory bodies in 2025. In line with the “leave nothing behind” trend, the Group is also investing in proprietary paclitaxel DCB, with clinical trials expected to commence in the fourth quarter of 2025 in Japan.
During the year, the joint venture OrbusNeich P&F made significant efforts to advance the clinical studies of TricValve in two major APAC markets. The clinical trial in the PRC started in April 2024, while the PMDA clinical trial protocol approval in Japan is expected to be completed by the end of 2025.
In addition to proprietary products, the Group also entered into a distribution agreement with a Chinese manufacturer to distribute its intravascular ultrasound (IVUS) catheter in Hong Kong and Macau from December 2024, thereby diversifying its product offerings.
Exceptional Product Quality Ensured through Stringent Production Processes
As of December 2024, OrbusNeich’s annual production capacity reached approximately 2.0 million units of balloons and 60,000 units of stents, with product quality ensured by a strict management system and maintaining ISO 13485 certification. Notably, eucatech AG successfully passed its ISO 13485 re-certification audit in the latter half of 2024, while the Shenzhen site achieved ISO 14001 and ISO 45001 certifications in June 2024, highlighting its commitment to sustainability.
In addition, the construction of the Group’s largest R&D and production facility in Hangzhou, PRC, progressed smoothly during the Year. The Group is currently focusing on enhancing its automation levels to reduce labor requirements, improve operational efficiency, and ultimately lower overall operating costs. The facility is expected to be operational in 2027 and will add an annual production capacity of 2.4 million units upon the commencement of production.
Mr. Chien concluded, “Entering 2025, we are cautiously optimistic about our prospects given the strong growth momentum in APAC and EMEA, as well as the recovering US and PRC markets. Over the past 25 years, our success has been fueled by continuous innovation, product line expansion and a strengthened sales network. These efforts, together with the synergies from the integration of our acquired businesses, will position us well to capitalize on the opportunities that lie ahead. With robust financial resources, we are able to take advantage of industry consolidation for strategic mergers and acquisitions to enhance our technological reserves and expand our product portfolio. To maintain our steady growth in the medical device market, we will place greater emphasis on sustainable development to adapt to the evolving healthcare landscape while staying true to our mission of improving patient outcomes.”
About OrbusNeich Medical Group Holdings Limited
OrbusNeich is a major global medical device manufacturer 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 neuro vascular intervention and 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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