OrbusNeich Records Net Profit of US$18.8 Million for the First Half of 2024

Results Highlights:

• Revenue and net profit reached US$78.9 million and US$18.8 million, respectively.
• APAC market revenue grew significantly by 31.0%, driven by both organic growth and contributions from SJ Medicare and PT Revass, the South Korean and Indonesian distributors acquired in Q4 2023.
• Total sales volume of proprietary products remained at 717,000 units.
• In 1H2024, the Group made extensive efforts to integrate eucatech AG, a German company acquired last year, into its operations and reorganize its production lines, and expects eucatech AG to resume production and shipment in Q3.
• The Group has been actively registering products of eucatech AG in various countries and regions, and eucaLimus, a coronary drug eluting stent, has already received registration approval in Malaysia.
• For the clinical studies of TricValve, patient enrollment has commenced in 13 hospitals in the PRC. In Japan, the Group is working closely with the Pharmaceuticals and Medical Devices Agency (“PMDA”) and the US Food and Drug Administration (“FDA”) to prepare for the clinical trial and registration process.
• In May 2024, the Group engaged the main contractor for its largest R&D and manufacturing facility in Hangzhou, which is expected to begin operation in 2027, adding an annual production capacity of 2.4 million product units upon commencement of production.
• The Group’s financial position remained strong, as evidenced by the cash and bank balances of US$246.7 million as of June 30, 2024.
• The Group expects to maintain a stable dividend policy, demonstrating its confidence in future prospects.

(Hong Kong, August 16, 2024) – 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 interim results for the six months ended June 30, 2024 (the “Reporting Period”), with revenue and profit for the period attributable to owners of the Company maintained at US$78.9 million and US$18.8 million respectively despite various market challenges.

Mr. David Chien, Chairman, Executive Director and Chief Executive Officer of OrbusNeich, said, “The global economy has been highly volatile in recent years, as a result of factors such as geopolitical tensions and major central banks shifting their monetary policies. Albeit the challenging external environment, we were able to seize the opportunity to implement a series of measures to enhance operational efficiency and integrate the businesses of SJ Medicare, PT Revass and eucatech AG acquired last year into our Group. We believe the investments made in the first half year are crucial to supporting our future sustainable growth.”

For the Reporting Period, the Group’s revenue decreased slightly by 3.1% to US$78.9 million, mainly attributable to decline in sales volume in the US due to integration of Cardiovascular Systems, Inc. (“CSI”) into Abbott Laboratories (“Abbott”), and in the PRC market due to on-going impact of anti-corruption campaign, as well as the Group’s termination of distribution of certain third-party products, despite the significant sales growth recorded in APAC, as well as the modest revenue growth in Japan in terms of Japanese Yen. Excluding the impact of the foreign exchange fluctuations, total revenue would have recorded a slight year-on-year increase of 0.6%. Gross profit amounted to US$55.8 million while gross profit margin stood at 70.7%.

Despite the decline in revenue and the short-term increase in expenses incurred by the Group’s series of measures to enhance operational efficiency and integrate the businesses acquired in the previous year, the Group maintained a healthy level of net profit for the first half of 2024. It is worth noting that, excluding the operating expenses of the newly acquired businesses, the three core operating expenses, namely selling and distribution expenses, general and administrative expenses and research and development expenses, for the first half of 2024, remained flat against the same period last year. As of June 30, 2024, the Group maintained a strong financial position with cash and bank balances of approximately US$246.7 million, laying a solid foundation to support its growth objective.

Robust Balloon Sales in APAC and EMEA

The Group’s proprietary balloon products continued to gain traction worldwide. In the first half of 2024, revenue from the APAC market saw organic growth of a marked 8.6% year-on-year, thanks to strong balloon sales growth in markets such as Malaysia, Hong Kong, India, Vietnam and Singapore. Particularly, the latest generation of scoring balloon, Scoreflex TRIO, recorded a rapid rise in sales since it was launched in Malaysia in early 2024. Together with the additional contribution of US$4.3 million from the SJ Medicare and PT Revass, distributors acquired in South Korea and Indonesia respectively in Q4 2023, the revenue generated from APAC amounted to a total of US$24.0 million, representing a significant increase of 31.0% year-on-year.

In addition, mainly attributable to the increase in sales of the Group’s proprietary balloon products in direct sales markets such as Germany, France and Spain, as well as distributor sales markets including Czech Republic and Slovakia, revenue generated from EMEA slightly increased by 1.3% to US$19.2 million, even being partly offset by the termination of distribution agreement with CSI for atherectomy products.

During the first half of 2024, Scoreflex TRIO continued to drive revenue generated from Japan, the Group’s largest single-country market, in terms of Japanese Yen, achieving an 8.1% increase year-on-year.

Integrating Newly Acquired Business to Drive Future Growth

Following the acquisition of eucatech AG in November 2023, extensive efforts were made to integrate eucatech AG into the Group’s operation and reorganize production lines. The Group has been actively registering eucatech AG’s four products, namely eucaLimus, Support C, Resistant, and VITUS, in various countries and regions to avail those products via the Group’s own sales network to physicians and patients in different markets. In the first half of 2024, eucaLimus was granted registration approval in Malaysia, one of the Group’s direct sales markets. Registration applications for eucatech AG’s products have also been submitted to relevant regulatory bodies in Hong Kong, Malaysia, Switzerland, Italy and Saudi Arabia and are pending approval. The Group also promoted eucatech AG’s products at major conferences including EuroPCR, as well as educated distributors about these offerings so that sales could be ramped up smoothly once the products become available.

In April 2024, the Group supported eucatech AG’s on-site Medical Device Directive (“MDD”) and Medical Device Regulation (“MDR”) surveillance audit, as such, was able to extend the CE Mark expiration dates for their 4 products under the MDD framework. All these efforts are expected to see eucatech AG resume production and shipment in the third quarter of the year.

Relentless Drive to Translate Innovations into Thriving Product Lines

As of June 30, 2024, OrbusNeich had an aggregate of over 50 approved products. The Group has maintained a steadfast commitment to translating its R&D efforts into commercially successful products. To date, the Group achieved major milestones, including:

• Obtaining NMPA approval for Teleport Neuro, FDA approval for Teleport XT and JADE PLUS 14/18/35 OTW, CE Mark for Sapphire ULTRA and Sapphire NC ULTRA;
• Submission of registration applications to the NMPA for its Guiding Catheter;
• Completion of the clinical trial patient enrollment for Scoreflex TRIO in the PRC, with the NMPA application expected to be submitted in Q3 2024;
• Preparation for the Sapphire 3 clinical trial in the US, with enrollment scheduled to begin in Q3 2024.

Alongside these regulatory and commercialization efforts, the Group continued to invest in new pipeline products, such as the Corepass modular microcatheter, support catheter and the JADE Plus. Registration applications for these innovative offerings are planned for submission to various authorities in 2024.

Meanwhile, the joint venture OrbusNeich P&F made significant efforts to advance the clinical studies of TricValve in two major Asia Pacific markets. Patient enrollment has commenced in the PRC for its clinical trial, and the clinical trial and registration process in Japan is being prepared in close collaboration with the PMDA and the FDA.

Boosting Production Capacity through Rigorous Quality Processes and Operational Excellence

The Group has always prioritized product quality, which is ensured by a robust quality management system. During the Reporting Period, various sites successfully passed audits conducted by various regulatory and notifying bodies. Furthermore, the Group remains committed to enhancing operational efficiency and reducing production costs by continually optimizing manufacturing processes, work-in-progress inventory levels, and employee productivity. To meet future production needs, the Group will construct its largest R&D and manufacturing facility in Hangzhou, the PRC, for which it engaged the main contractor in May 2024 and which is expected to begin operation in 2027, adding an annual production capacity of 2.4 million units of products upon commencement of production.

Mr. Chien concluded: “Looking ahead, as new sales strategies are being executed in the PRC and the US markets, we expect these key geographies will regain growth momentum in second half of the year. Meanwhile, OrbusNeich has maintained active efforts to expand our market presence. On the product front, we are leveraging our comprehensive sales network and brand recognition to market innovative endovascular intervention products to enhance the solutions we provide to the physicians. New products from eucatech AG which is expected to resume production soon will also contribute to improved profitability. We are also actively identifying M&A opportunities that align with our strategic priorities and position us for sustainable growth. Despite the first-half headwinds, we remain optimistic about restoring growth momentum soon and expect to maintain a stable dividend policy for shareholders based on our robust financial position.”

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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, OrbusNeich sells its products in more than 70 countries and regions worldwide. It is also actively expanding into neuro vascular intervention and structural heart disease. As of June 30, 2024, OrbusNeich has more than 230 granted patents and published patent applications worldwide. Its in-house R&D team has more than two decades of product development experience and has developed world-leading proprietary technologies.

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