Terumo Corp

Thank you for joining today's real big starting our financial announcements.

So I'd like to first ask CFO Kagemoto-san to talk. Then next I'd like to hand it over to CEO Kagemoto. to talk about the direction and the core businesses for TIS. So, followed by that, we'll do the question and answer. And we will take 16 minutes for the combined presentation and the Q&A. We have simultaneous translation in Japanese and English. You can see what both of them And please use the audio button at the bottom to change the language. By the way, the screen will only present it with the Japanese version of the slide. English version can be downloaded. We'll let you know if there's a technical problem on the streaming. We'd like to ask you some asks before we start. We will be talking about the projection of the future businesses, all of which comes with uncertainties or risks. Please, the actual result may be different from our projections that we'll be presenting today. With that, I'd like to ask Hagimoto to be talking about our financial result. Hagimoto-san, would you please go first? Yes, I'm Hagimoto, the CFO. Let me walk you through the highlights of our financial results for the second quarter of the fiscal year ending March 2026. I'd like to talk about our second quarters. This is our highlights. We continue to benefit from favorable business environment. Our revenue for the first half reached a record high of $534.9 billion. In particular, demand is not very much strong, resulting in an 8% decrease in revenue on a local currency basis, or in profit adjusted by profit and profit for the period all reached record highs for the first half. In addition to increased revenue, profits are growing at a pace that exceeds revenue growth driven by global pricing measure and appropriate cost control. In light of the current business, In writing recommendations, we have revised all full-year guidance announcements in May. We have upwardly revised revenue and adjusted revenue profit, reflecting the strong fundamentals and changes in foreign exchange assumptions, particularly in depreciation. On the other hand, we have incorporated temporary costs related to the strategy in issues such as accretion-related expense. and continuous portfolio reviews into operating profit of what i will explain the details later next slide Moving on to our P&L performance, revenue was driven by CNV and TBCT companies. Despite negative currencies' impacts, revenue for the first half reached a record 534.9 billion yen. Operating profit and adjusted operating profit both grew faster than revenue, reaching record highs of 101.0 billion yen and 114.4 billion yen respectively. From the second quarter, charity impacts began to materialize, but profit growth was achieved mainly through price measures and appropriate cost management. Since the year-on-year OP variance analysis for the second quarter reflect the same trend as the first half, we will provide further details on the next slide. op variance analysis for the first half is this overall increased sales driven by continued demand expansion contributed to growth to profit growth gp increments increment by sales increase led by overseas tis especially in north america and by plasma business under global black solution gross margin price pricing measures in the cmd contributed significantly to traffic growth though positive effects were partially offset by Kyiv's inflation and mixed effects. S&J increased, with business expansion remaining within expected levels. And research and development decreased slightly year-on-year, partially due to last year's impairment losses on capitalized R&D. foreign exchange impact negative both on flow and stock basis compared to the previous slide. Let me now explain results by companies. Please note that the revenue by region slide, which was previously shown earlier, is now placed and comes after the revenue by company slides. First, the cardiac and vascular company. Revenue grew by 8% on local currency basis with strong global performance centred in North America, TIS and New World Bank growth, while CardioVascular also achieved high single-digit growth in local currency, driving overall company performance. Although Eltech experienced supply issues with surgical vascular products during the first quarter, Revenue rose due to recovery trends from the second quarter and strong progress in expanding sales of hybrid products. Urban profit improved by 2.27%. Pricing measures, profitability improvement measures, and unprofitable regions have contributed. FX stock impact was negative, resulting in a slight decrease in margin compared to the first quarter, but fundamentally remained solid. Next slide, please. Next is the TMCS, the medical care solution company. Revenue for the first half increased driven by growth in pharmaceuticals. This growth reflects the impact of the retirement shift in certain areas of the domestic CDMO business being recorded in the second quarter, along with the continued strong performance of projects overseas. Ashfall Care saw a temporary revenue decline due to last year's business transfer and ongoing supply issues for some products. Pricing measures started in April are progressing very well. Traffic growth was supported by recovering pharmaceuticals. Continuing to TBCT, the blood and cell technology company. When it grew significantly in plasma innovation and the global blood solutions, RECA deployment to existing customers were completed in the first quarter and operational optimization will continue. Co-businesses are progressing as expected. In global therapy innovations, revenue increased due to growing demand for cell collection in cell and gene therapy, especially in the U.S., along with replacement demand for shaking devices. Profit increased, led by input profitability from higher sales. Next slide, please. And this is our revenue by region. In America, demand and expansion continued with double-digit growth in local currency. All companies showed strong growth, with TIS-funded pharmaceuticals and global blood solutions serving as key drivers of global revenue. In Europe, stable growth in TIS and euro and strong performance of pledge-extra pharmaceutical segment growth. In Japan, pharmaceuticals contributed to higher revenue. Supported by the recognition of delivery timing adjustments in CBMO during the second quarter, Neuro sustained its double-digit growth trend in CNV. In China, Neuro maintained strong growth, supported by the successful expansion of sales channels under DBP, resulting in higher revenue. In Asia, C&D achieved revenue growth while hospital care pharmaceuticals and global black solution posted declines in the first half due to delay in tender timing. Now, recording our guidance revision. To begin, we will explain the assumptions underlying the revision of our guidance, focusing on two major points. First, regarding the fundamentals of our existing businesses. As we shared in the first half results earlier, the fundamental remains strong. Thanks to continued robust demands and the successful implementation of Proactive pricing measures. We expect profit increase of 10 billion yen compared to the figures announced in May. This effectively offset the anticipated 10 billion yen negative impact from tariffs for the current fiscal year. In addition, we have reflected changes in foreign exchange assumptions due to the continued depreciation of the yen, resulting in an expected increase of 10 billion yen in AOP for existing businesses. Separately, we have factored into public costs related to strategy research available for the growth, including acquisition, and continued portfolio optimization into this year's guidance. Based on the assumptions outlined earlier, we have revised our full-year guidance announced in May by upwardly adjusting revenue and adjusted operating profit, and downwardly adjusted operating profit. The guidance excluding the impact of the acquisitions announced this year is also presented at the slide. On this basis, both revenue and profit for the full year have been revised upward. and both revenue and profit were adjusted. Here are the details by company. CNV and TBCT reflect strong performance with upward revisions for both revenue and profit. For CNV, continued robust demand in North America and pricing measure will remain key drivers in the second half. DBCT continues to be driven primarily by product renovation. However, due to higher-than-expected collection efficiency with RICA, turnover of disposable products industry can have expected defaults slightly below plan. Accordingly, production adjustments are scheduled for the second half, so the efficiency improvements support a solid foundation for long-term growth. Conversely, TMSC has been revised downward in profit, mainly due to aggregation-related expenses. We have also included organox performance from November onward, with cumulative 5-month revenue projected at 9 billion yen and adjusted operating profit at 1.3 billion yen. Let us now explain the revision of adjusted operating profit. Overall, we have revised the initial guidance from 214.0 billion yen to 221.5 billion yen. strong fundamentals and effective cost control have offset the 10 billion negative impact on cash in addition we have reflected the positive impact of favorable exchange rates compared to the initial guidance we have also incorporated strategy investments including the capital expenditure for the lever crossing plans as well as the contribution from organox acquisition. Details of the adjustment items that account for the difference from the operating profit will be presented on the next slide. The adjustment items have increased by 20 billion yen from the initial guidance of 20 billion yen to 40 billion yen, with two main components accounting for the increase. The first is acquisition-related expenses, including costs associated with the organized acquisition and amortization of acquired intangible assets, totaling at approximately 39 billion yen. The second is costs related to portfolio review, primarily expenses Arising from that vision of the exclusive distribution agreement related to TIS business also totaling around $900 a year, we continue to conduct strategy business reviews to support further growth. The above costs were not included last year due to the ongoing discussions to the initial requirements, but the efforts toward portfolio optimization will remain priority going forward. Lastly, as we have consistently continued, we are on track to deliver the three financial goals outlined in GS26 with three new goals, operating profit, percent, and capital efficiency. Although acquisition-related and one-time expenses will be incurred this fiscal year, doubling profit per cent for FY25 per cent, excluding these costs based on our existing business is 18.6 per cent. Our business fundamentals will solve it, and this momentum will remain unchanged will continue to make proactive investments to drive future growth, ensuring the achievement of GS26 and further enhancement of Korea Valley. This concludes my remarks. Thank you very much for your attention.

I'd now like to hand over to CEO Mr. Samejima. Hello, I'm CEO Samejima, and today I would like to talk about the strengths and future outlook of Teramo's core business, the TIS division, which continues to drive robust growth and lead the company this fiscal year. And in particular, I would like to focus on our imaging strategy. And finally, I'll provide an update on the acquisition of Organox. Despite the impact of PCI market maturity, the TIS division continues to deliver high single-digit growth. This growth is underpinned by the stable performance of access products, which account for half of our revenue. And in the therapeutic segment, products such as therapeutic lesion access, namely PTC-A guide wires and microcatheters, are contributing to this momentum. And as you can see, access and TLA, these fundamental device groups, make up more than 80% of our sales. And this is a key differentiator from our competitors, enables us to maintain a unique position and achieve sustainable growth. Here are the highlights of the TIS growth strategy on this slide. In the access market, we will continue to strengthen the number one position that we have built and maintain mid-single digit growth. And as the second pillar, TLA products will achieve high single-digit growth by expanding market share in addition to overall market growth. And beyond these existing drivers, I would like to highlight imaging as the third growth area. Imaging usage has been increasing in recent years in Europe and the US, and Terima will deliver double-digit growth by introducing a unique new product, the Dual Sensor System. So first let me reiterate the strengths of the TIS division that are common to both Access and TLA products. The first is our core technology, advanced manufacturing capabilities. Our hydrophilic coating, which enables smooth manoeuvrability inside blood vessels, is one of the technologies that physicians have trusted for many years. In addition, the precise engineering of each component ensures ease of use and reliable device control, supporting seamless procedural flow. Interventional procedures are largely invisible to the naked eye, and the subtle tactile differences that only the physician can sense are the true source of TIS's unique strength. The second is consistent, large-scale, multi-product manufacturing. Our scale advantage creates a barrier to entry that competitors cannot easily overcome, delivering price competitiveness. Furthermore, by producing high-quality products with uniformity and minimal variation, we provide physicians with the confidence that using Teramo products will deliver a familiar feel in daily clinical practice. Beyond simply supplying products, we have pioneered the radial approach and promoted its value. Through a comprehensive product lineup that enables same-day discharge and appropriate use training, we support safer and more efficient hospital operations. By delivering our unique technologies and operational expertise as part of our solution platform to clinical settings, we transform what are generally considered commodity products into high-value offerings. This is exactly the fundamental strength of the TIAS business and the foundation of Teramo's leadership. The access and TLA demands present significant potential for future growth. For access products, the main intervention market is expected to continue growing at mid-single digit, and Teramo aims to solidify its presence through the further adoption of the radial approach. Moreover, access devices are widely used beyond the main segment. The trust earned through high-quality devices developed for the intervention market has made Teramo a preferred brand. And as the number of cases in these domains increases, there are opportunities to use access products which will expand even further. In the TLA product group, which is essential for delivering stents and coils to the lesion site for treatment, Teramo has now established itself as category leader. By steadily increasing the market share of wires and microcatheters across various treatment areas, we have achieved a growth rate that exceeds overall market growth. These products, which are used routinely in large volumes, clearly showcase the strengths of the TIS business that I have been emphasizing. The growth potential of TLA products is my next point. The key lies in expanding the product lineup and broadening both business domains as well as geographic reach. Through continuous innovation, we respond to evolving treatment trends and develop products that meet clinical needs, supporting daily procedures and therapies. We also accelerate growth by quickly capturing market opportunities beyond existing areas. In recent years, catheters have been increasingly used in MSK embolization, which is a treatment for chronic pain such as joint pain. and this market is expanding very rapidly. The future market size is estimated to exceed $500 million, and Teramo has already secured a significant share with microcatheters, positioning us for continued growth. From a regional perspective, introducing products into Asia and Latin America offers even further opportunities to achieve growth. Now let's move on to the third growth driver, the imaging segment. the global imaging market is expanding driven mainly by the US and China and it is expected to reach 1.3 billion US dollars by 2031 this growth is supported by accumulated evidence that using imaging improves outcomes in interventional procedures in the US imaging guiding PCI has recently achieved the highest recommendation level which is class 1 evidence level A at major medical societies this year and furthermore the increasing adoption of atherectomy and IVL devices has reinforced the need for imaging assessment of calcified lesions. The penetration rate of imaging in PCI in the US is projected to rise to 56% by 2031 making imaging a high potential area that is now the tipping point for significant growth. Terumo has been competing to lead the imaging segment for the long term. In Japan, imaging is used in more than 95% of PCI cases, and Terumo holds an overwhelming market leadership, with a share exceeding 50% in this home Japan market. Teramo's strengths in imaging lie in three key areas. The first is superior catheter deliverability. Secondly, clear, high-resolution images. And thirdly, simple, speedy operability. As the global market expands, the fact that Teramo imaging is the top choice in Japan, the country which is most experienced with imaging, represents an immense value. Currently, two modalities are available for imaging, IVUS which uses ultrasound and OCT-OFDI which uses near-infrared light. IVUS excels at assessing the overall condition of the vessel and is suitable for cases with large vessel diameters, but it is less effective for examining microstructures. But on the other hand, OCT or OFDI offers high-resolution imaging, making it ideal for evaluating stents and microstructures and is particularly effective for calcified and bifurcation lesions. However, it has limitations in visualizing the entire vessel and requires a blood flush using contrast agents. In clinical practice, due to cost constraints, in most cases only one modality can be used, leaving physicians unable to view both images even when they want to. To address this challenge, Teramo has developed the Dual Sensor Systems, or DSS. This innovative system features a catheter equipped with both IVUS and OFDI sensors, enabling simultaneous acquisition and output of two images. By leveraging the strengths of both IVUS and OFDI, DSS allows for a more accurate depiction of intravascular conditions. Its value lies in supporting the realization of the optimal treatment strategy for any case. This is DSS's highest value. And with DSS, the step of deciding which modality to use disappears. Physicians can compare both images side by side to make the best treatment decisions possible. And at a time when imaging market is poised for significant expansion, Teramo takes on the challenge with DSS. With the launch of DSS in Japan and the US, imaging sales are expected to grow to more than three times their current size by 2031. In Japan, we will leverage our established market position and begin introducing DSS at facilities with high appetite for this technology. By pricing DSS above the current standard of IVUS to reflect its added value, we can drive growth. At the same time, we aim to quickly accumulate clinical data in the US to establish meaningful evidence of DSS's clinical significance. In the US, meanwhile, as a new market entrant, we will take a phased approach to market introduction. By combining TerraMOS' proven imaging strength track record with the unique value of dual technology, we will steadily build a loyal customer base. Additionally, we are preparing to integrate AI technology to enhance software capabilities and tailor solutions to meet the precise needs of users in the US. Beyond Japan and the US, demand for imaging is expected to rise globally and teramo imaging holds significant potential for rapid growth through further geographic expansion the tis business has long been a core driver of teramos growth and that role will remain unchanged we see further growth opportunities in access and tla where we already have established strong positions On top of this solid foundation, the launch of DSS will bring a new level of evolution to the business. Of course, we are also looking ahead to expanding into therapeutic product areas, including strengthening our pipeline through M&A. And by adding DSS to our portfolio, we will create synergies with therapeutic products and further enhance Terima's presence in endovascular treatment. Finally, an update on the acquisition of Organox, which was announced in August this year. And as stated in our recent press release, we successfully completed the acquisition of Organox on October 29th. First of all, regarding our recent performance, for calendar year 2025, revenue is expected to reach up to $120 million, which represents approximately 70% growth over last year. This reflects continued strong demand driving high growth. Excuse me. So the market expansion, specifically the increase in liver transplant procedures enabled by the adoption of NMP technology combined with Metro's rising market share quarter after quarter, underscores the strong momentum, and these results validate the high expectations for organ perfusion technology in METRA's proprietary innovations. Since NMP was approved in 2021, the use of cardiac death donors has rapidly increased, driving a rise in liver transplant procedures, a trend that will continue this year. NMP also enables planned transplant surgeries, significantly improving quality of life for medical terms. Looking ahead, transplant numbers will keep growing, and as NMP becomes the standard method for liver preservation, it means more precious organs can reach patients on waiting lists. The growth potential for METRA is enormous, as discussed previously, and Organox is to reach a scale of around 100 billion yen in revenue over the next 10 years. Moreover, as transplant volumes increase, more potential patients will be added to waiting lists. This represents a major step toward turning hope into reality for all of those suffering from liver disease. In the NMP market, METRA also holds a strong competitive advantage. As mentioned in our previous briefing, real-time monitoring enables quantitative assessment of organ function, improving utilization rates of donated livers. Additionally, the ability to preserve organs with a simple operation is a major differentiator, and its automated control function reduces the burden on clinical staff. This automation also allows flexible transport options, enabling customized services tailored to each case. By selecting the optimal service for each case, preservation and transport can be achieved with minimal resources, delivering significant cost benefits. Even when offering a full package service that includes transport, Organox maintains its price competitiveness, which has steadily driven market share growth. So finally, let's talk about synergies. METRA supports the preservation of liver function by perfusing the organ with an oxygenated, temperature-controlled perfusate containing blood delivered through a centrifugal pump with precise flow control. Teramo has long supplied all these key components, the centrifugal pump, oxygenator, heat exchanger and reservoir, under the Capiox brand. And in addition, anticoagulants and other drugs are administered via syringe pumps, which are also one of Terima's strengths within its TMCS infusion management business. When you break down METRA's structure, it becomes clear that it is built on perfusion technology that Terima has cultivated for many years. By combining the technologies of both companies, we can unlock the potential for next-generation perfusion solutions that are even more innovative and competitive, while also improving profitability through cost synergies from component integration. Organox is highly innovative and poised for growth. But by leveraging Teramo's platform, its growth and next-generation device development opportunities will expand dramatically. Terimo is adding a new frontier in perfusion to its portfolio and is thoroughly committed to becoming a global top-tier company. Thank you for your attention.