Good evening, gentlemen. Thank you very much for joining us for the explanatory meeting about the acquisition despite the short notice and despite your busy schedule. I would like to now officially open the explanatory meeting about the OrganOx acquisition. We're four of us: Mr. Hikaru Samejima, CEO.
Mr. Jin Hagimoto, Group Executive Officer, CFO.
Mr. Kenichi Hatta, Group Executive Officer, General Manager of the Strategic Planning Department.
Myself, Otaka, General Manager of the Corporate Planning Department. First of all, the overview of the acquisition will be presented by Mr. Samejima, to be followed by about one-hour Q&A. This is the hybrid meeting. We have analysts on site, and investors are participating online.
For the online participants, I hope you can use the Zoom simultaneous interpretation function. Japanese, English, the choice is available. At the bottom of the page, you see the globe mark. Clicking that, you can switch between the English and the Japanese. The screen will be projecting the Japanese language, and the presentation materials in both languages are put on our website. Now, Mr. Samejima will present you the outline of the acquisition.
A good day, everyone. I'm Samejima, CEO of Terumo. Thank you very much for joining us today on such short notice despite the hot weather. Thank you very much. I'm so glad that you're here in our new office. On August 23rd, Terumo Corporation signed an agreement to acquire OrganOx, headquartered in Oxford, U.K.
Today, I'd like to explain the background and the future outlook of this acquisition.
Terumo makes its entry into organ transplantation through the acquisition of OrganOx, an innovative specialist which develops and manufactures devices for preserving transplant organs.
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Let me first give you the overview. This acquisition involves the purchase of 100% of OrganOx and outstanding shares for a total cash consideration of $1.5 billion.
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The funds will be sourced from cash on hand and borrowings. The agreement was signed on August 23rd, 2025, and we aim to complete the closing within this fiscal year.
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Back in 2008, OrganOx spun off the University of Oxford and has been globally deploying its Metra.
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Device for preserving transplant livers. This is a spin-out from the University of Oxford. Two members of the commercial core team are on the Oxford Academia. There is so much involvement on their part about academic and professional perspectives. They are indeed committed to help as many patients as possible. That's the fundamental spirit. The company has been globally deploying its Metra device for preserving transplant livers. It got a CE marking in 2016 as the first normothermic machine perfusion device, and it was also FDA approved in 2021. It was launched in the U.S. in 2022 with its 199 employees. The company's calendar 2024 sales revenue was $71 million, and this acquisition is expected to be the biggest ever for a spin-out from the University of Oxford. In 2017, Terumo began supplying CDI sensors for Metra, deepening our insight into OrganOx and its technology.
With Terumo Ventures' recent investment this particular year, we have been building relationships with the company.
Regarding the significance of this acquisition, this acquisition is strategic and essential for the Terumo Group. Entering organ preservation, a new growth domain, we can chart a growth trajectory beyond the extensions of our existing businesses. It is a key step to achieving the bold growth beyond GS26 that I have been advocating for as CEO. Terumo's time-honored tech and expertise and OrganOx' innovative devices and know-how put together should globally increase transplant opportunities and globally contribute to address the serious unmet need shortages of transplant organs.
We also expect entering the high-growth organ transplantation market and acquiring a highly profitable business model to elevate Terumo's corporate value significantly. I'm confident that this deal will contribute to maximizing Terumo Group's value with synergies with our existing business for the creation of new solutions. This acquisition is essential to unlock Terumo's future and open doors to our next growth stage. The following slides provide more details on these points. Organ transplantation for end-stage organ failures is extremely effective, and its global demand is rapidly increasing. The global number of organ transplants exceeds 150,000 per year. The supply falls short of demand, and many patients die while on the waiting list. 470,000 patients are registered on the waiting list, but some patients aren't listed because of the supply shortages. Some patients with deteriorating conditions go off the list and pass away.
The number of waiting patients is estimated to be potentially 10x the number of actual transplantations. With rapidly increasing demand, continued high growth of the market is expected. Here is the organotype breakdown. This acquisition marks our entry into the liver transplantation, where one of the biggest unmet needs exists. The challenges of transplant liver shortages are twofold: few donors and the low utilization rate of donated livers. In particular, DCD, or donation after circulatory death, makes things difficult. Livers are vulnerable to ischemia. Transplantation rate is high for brain-dead donors with intact blood circulation, but the rate is extremely low as opposed to circulatory-death donors, which are far more numerous. That constraints the overall donor pool. Livers may only be preserved for a short time, limiting transport distances, often requiring emergency surgeries, lowering healthcare providers' QOL.
Not a few potentially transplantable livers end up not being transplanted for safety concerns because it's difficult to quantitatively assess organ functions.
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OrganOx technology directly addresses the challenges in liver transplantation by helping to both increase the number of available donors and improve the utilization rate of donated livers. The preservation method used in OrganOx' Metra device, known as NMP, differs from conventional techniques that rely on cooling to minimize damage. Instead, NMP circulates oxygen and nutrient-rich preservation fluid through the organ at near-body temperature, enabling significantly longer preservation time. While the traditional method allows for only a few hours of liver preservation, Metra has received regulatory approval for up to 12 hours in the U.S. and up to 24 hours in Europe. This extended preservation window enables the use of donors from distant locations and allows for planned non-emergent surgeries. In addition, Metra's real-time monitoring and automated control systems ensure stable management of the organ's condition during preservation.
This not only improves transplant outcomes by using organs with preserved functionality, but also enables more accurate assessments of organ vitality potential, allowing for the use of organs that would otherwise have been discarded. In addition to expanding our business through existing liver preservation devices, we also anticipate growth through the development of new solutions. One such initiative is the development of a compact version of our current product known as Metra-L. By making the device smaller and easier to transport, we aim to increase its adoption across a wider range of clinical settings. Furthermore, we are planning to expand beyond liver transplantation into kidney transplantation. Kidneys represent the largest segment of the organ transplant market, and transplants from donors after cardiac death are more common. However, major challenges remain. The high discard rate of recovered kidneys is a real problem.
By leveraging Metra's real-time monitoring and automated control capabilities, we aim to reduce the discard rate of transplantable kidneys and make more effective use of these valuable medical resources. We are targeting practical implementation around 2030, and preparations are already underway to accelerate the growth of existing Metra business. OrganOx has achieved rapid growth by offering innovative solutions to address the clinical unmet needs of organ shortages. Since the launch of Metro in the U.S. market in 2022, the company has expanded its presence swiftly, surpassing JPY 10 billion in annual revenue last year. With the continued expansion of the market driven by NMP technology, OrganOx is now on a growth trajectory that realistically envisions annual sales reaching JPY 100 billion within the next decade. From a profitability standpoint, the company achieved positive adjusted EBITDA just one year after the U.S. launch, which is very rare for any startup companies.
[Foreign language] Let me talk about the financial impact. Excluding amortization of intangible assets and one-time expenses, the acquisition is expected to contribute positively to adjusted operating profit. During the closing, we plan to disclose further details regarding the goodwill and intangible fixed assets. In terms of earnings per share, the acquisition is also expected to have a positive impact starting next fiscal year, when special factors related to the transaction are excluded. The funds for the acquisition will be sourced from cash on hand and debt financing. Beyond the growth driven by OrganOx' proprietary technology, we believe that creating synergies with the Terumo Group will generate even greater value for both companies. As many of you know, the Terumo Group possesses a broad product portfolio and advanced technological capabilities, enabling us to create powerful synergies across multiple domains.
OrganOx' perfusion technology enables the recreation of a physiological environment for organs such as the liver, even outside the human body. For example, Terumo's perfusion technology supports organ function by circulating, oxygenating, and regulating the temperature of blood outside the body. By combining these two technologies, it is possible to build a more advanced in vitro circulation environment. Beyond the TCV domain, combining the Terumo Group's unique technology and expertise with OrganOx products enables the development of innovative solutions with the potential to transform the future of transplant medicine. To fully leverage this broad integration, the business will initially operate flexibly and dynamically, as a new unit will report directly to me as the CEO, rather than being placed under an existing company division. OrganOx will serve as a strategic platform to accelerate Terumo's entry into organ transplantation.
In addition to perfusion technologies, these access to clinical cold points and R&D network will enhance our existing operations and drive new growth through the complementary technologies and products. As mentioned at the onset, the purpose of this acquisition is to achieve leapfrog growth for us. The integration with OrganOx will bring high-growth business domain to Terumo, where synergies with our broad portfolio of existing products and technology will continue to expand the scope of future solution offering. Most importantly, OrganOx' technologies and products are clearly helping to solve major challenges in organ transplantation challenges that align perfectly with Terumo's strategic direction. Delivering donated organs as a precious medical resource in optimal condition to patients is a direct embodiment of Terumo's our promise and a steadfast commitment to those we serve.
The acquisition represents a bold challenge to contribute to the future of medicine, leveraging the technologies and expertise Terumo has cultivated over the years. We are confident that entering the organ transplantation field will allow us to build an even more advanced and impactful portfolio. That concludes my slide presentation, but I'd like to make a few comments before I finish. Ever since I became CEO last year, I have made a criteria. There are a few criteria that are important for identifying targeting companies or scanning of the target companies. Is this target company really able to give a groundbreaking technology to contribute medicine for the health of patients? The other one is like a differentiation, uniqueness, something it's very difficult for competitors to copy. Do they have that technology or business model? Number three, do we have synergy, leveraging synergy with Terumo?
Number four, of course, financial growth potentials and profitability. Number five is how close our cultures are. I would say it's very rare to find five boxes being checked. I actually told you that it's very difficult to find all the conditions being met as a top management. In this transaction, it's very rare. We found a very important treasure. We're very excited because it checks all the boxes. If looking back a few years from today, we are confident that we will be applauded with this transaction. Thank you very much. With that, I would like to get into question and answer. I'd like to first ask sales analysts to raise questions. We would also extend time to give some time to ask questions for people who are joining us remotely. Please raise your hand first in this room.
Please try to constrain questions to as many as two questions per person. Yamaguchi-san, please, you are the first, please.
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Thank you very much. I'm with Citigroup. Thank you very much. My name is Hidemaru Yamaguchi. Let me ask you a couple of questions.
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You mentioned the JPY 100 billion, approximately.
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Let's say regional expansion, the organ category expansions, and the size of the device is pretty important. I heard about that some time ago. To what extent would you expand when you have JPY 100 billion in scope? Is that 20x, 30x? What is the premise necessary for achieving that? Regarding the specific breakdown, I'm not quite ready to address. In terms of regions, currently, the U.S. has been the central market. Of course, we're thinking we should be thinking about expanding into other markets. As I mentioned in the presentation, the kidney entry, we're targeting to enter into that around 2030. The existing version upgrading may be one way. This is a new area, and many players are trying to enter into it. We want to maintain a differentiation. Upgrading, therefore, will be necessary, I think.
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When would you launch the small devices?
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Not quite next year, but certainly sometime before 2030. Let me ask you another question. You have existing competitors addressing this kind of device. The U.S. has certain companies with the devices, and they have the infrastructure, and you're making the new entry to make a big change. Is that the kind of a business that you're trying to address? Maybe you have already launched that kind of endeavor. What could be the biggest factor to take the shares? Technology for organ transplantation exists in large numbers, but the normothermic technology is few, not so many players. The real-time monitoring and the automated control, OrganOx has a special algorithm so that the organs will be maintained at the optimal condition when they are transported. That's the great value of the company. In 2022, following U.S. launch, the growth is pretty big.
The organ transplantation center medical doctors, surgeons, really highly rate OrganOx devices because of that. Thank you. Mr. Barker, please.
Jeffrey Schalke and Stephen Barker, let's do this.
Steve Barker from Jefferies Securities. Last year's revenue was about doubled. This year, how fast the growth is expected to grow? The top line. What do you say?
The growth percentage for this year goes back to some comment. We would hit JPY 100 billion or higher, hit JPY 100 billion in 10 years. In terms of CAGR, it's going to be more than 10%. Of course, the growth rate will be faster in earlier years. We can share that with more details, including the timing of it after the closure. Just a couple of anchors just happened the other day. This was not being, the AFH was not being used in the past. After the regulators, it becomes more convenient. Do you think that will accelerate the growth?
In the U.S., organ transplant mode of transportation, the majority of them are truck. Land transportation takes up about 70%. Air freight is about 30% in the U.S. Now it can be carried in the airplane. It's not going to be double, right? It will be non-neglectable incremental growth is coming from the airplane mode of the transportation. Thank you.
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Thank you. Next question, please, Mr. Otaka.
Thank you very much. My name is Mitsuke. I need to pick one question. Let me ask you about the differentiation. Overseas liver, their products, they were earlier in the U.S. This is the European company. You have the greater share in Europe. The CDI 50, 500, that has been used in the bypass surgeries, and the CDI sensor is installed. You have been on the watch for a long time. You have your strengths. The real-time monitoring, say the portal, the artery, and the pressure, and the circulation, you have been watching that. The competitors have been doing that. The CO2, O2, and the bile acid, glucose. What about their productions? You have been watching that. To what extent is that the strength? Am I right? You only have three buttons or so: start, stop, and just one more.
Is this strength about the real-time monitoring delivered function well assessed? The operation is easy. Are these strengths?
Two more things for differentiation, I believe. The automated control. It doesn't require the human involvement. One more thing. The other company, should I say that? Actually, different business model, I have to say. It's basically about the air transportation. Ours has a flexibility. Cost is different. The cost difference is pretty big, I believe. I see. Let me ask you another thing. The cost. According to the materials I saw, the cost is less than 50%, maybe 40%, if I remember right. That's too much. A national OCS program, they have the huge program, the Euro competitor. The harvesting to transplantation end-to-end is their business model. Your business model is about the device, the disposable, and the transportation. Transportation is in-house? No, the partnership. The price-wise, you have the price advantage.
The cost is almost half. These two are the advantages. The real-time monitoring is possible, easy to use, and the low price. These are the differentiating positives. Right. Acid, right? Acid, light, light. That's the kind of the business model we're looking at. Thank you very much. Thank you.
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Next question, please.
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My name is Sato from JP Morgan Securities. Thank you very much for this opportunity. The numbers of the cases of transplants and the forecast of the volume is my question. Numbers of transplant cases are not growing. If it's growing, what drives that growth? Can you just give me a little more context why it's growing, the market is growing? OrganOX or other companies have been, over the last several years, adapting, introducing very new technologies. The traditional way was simply putting to the icebox, right? It's very difficult, right? The preservation time is shorter. You don't have much control of the state of the organs. Now, preservation time is much longer. Therefore, it can drive the numbers of cases for transplant, for sure.
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I'm sorry. You're talking about the time for preservation. That's one, right? What about the total addressable market size? Including opportunity loss, right? Because it's less leakage is happening for organizations. I earlier talked about supply is where the bottleneck is happening. Supply is now becoming bigger because of technology innovations. The registered patients, the supply is the bottleneck today, right? Some patients who are, you know, their symptoms being very gotten worse, they should be receiving transplant, but they will not be having access to because supply was the bottleneck. That means if we have more supply, all the patients otherwise not be able to receive transplant will be able to receive transplant. That's how the market is growing. In terms of percentage, it's hold 10% or more. Is that how you expect the market to grow, 10% or plus? You asked me about the market. Two-digit growth. Okay.
Thank you. That's all.
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Thank you very much. Next question, please. Ishihara-san, please.
EBS Securities. My name is Ishihara. Thank you very much. I understand you're heading for closing an intangible assets area to be disclosed. The ROIC is difficult to calculate, but I'm trying to get a general image. [Foreign language]
Maybe some of the factors reduce the ROIC. I may be wrong about the calculus. You need to enhance the top line 50%. Otherwise, it doesn't pay in five years to come. Can you make comments about that wherever possible? Another question. I'm not familiar with the technology of this company, but let's say any businesses of yours, does the company's technology have any synergies with your existing businesses? Can you tell us about the synergy?
Okay. Regarding ROIC, let me respond to your question. You're right in part. The ultimate numbers will be disclosed post-closing. When we're in the early phase, it's going to be negatively kicking in into the...
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Immediately after closing. To what extent we have positive contributions, that's an important factor. As of now, as we think about the business model, we're thinking about towards the end of the last year of the midterm plan, it should be generating positive contributions. Of course, it's purely based on the current rough estimate. We will certainly have more specific detailed numbers down the road. In six, seven years, it turns positive. A bit more than six or seven years, but certainly less than 10 years. It should be positive. Contribution to ROIC, you mean just the acquired business alone, not including any peripheral things? We've been looking at the company standalone in our analysis. Standalone, ROIC is already positive, and the business is asset light. If we look at the business per se, ROIC is already positive. However, the current acquisition involves assets, intangible assets, and other things.
If we consider all of them, it may take six, seven, or a bit more years before the Terumo Group as a whole has to see the integration. Regarding the synergies, let me respond. There should be some synergy. In the presentation and in response to the question, we touched upon the automated control. Our components can be used, and the controls can use our components. Their technology, our components, put them together. Maybe we can do something more as a general image. As I mentioned, this is the Oxford spun technology. Terumo Venture is also used to also pay attention to other technologies as well. Unique technologies other than this one can be put together. Let me ask you another question. This acquisition, I believe, is a very good acquisition. Let me ask this question. Is this the end? The investors may have the feedback.
Terumo's catheter business is the core business. I believe that's the investors' understanding. After they released, the stock price slightly decreased. Unexpectedly, the stock price made a different move. Last year, April 1st, I took office as the CEO. In this industry, in terms of the growth strategy, the M&A is essential. No M&A, no discontinuous or leapfrog growth. This May, the drug filling factory was acquired, and this time, we're acquiring this. This is not the end of the story. Any good deals we come across, of course, we should certainly be happily considering that. Thank you.
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Morrison, you are next. Please go ahead.
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My name is Takahiro Mori from Nomura Securities. What I got confused a bit is, is this truly essential? Do they really have to have in terms of organ transplants? Today, icebox, right? Cheap, established, very simple and easy. With the perfusion, then marginal organs, organs otherwise being discarded, can be saved. That makes sense, right? What about your technology or future development? Can you make the perfusion approach that is essential? I think that's the key question for how do you see that pathway? Are you confident you can do that?
Metra currently uses one of the many components, which is CDI. We are the supplier of the hardware. Other components in the mid to long run, we can replace them to Terumo products. That's like one aspect of it.
Now, before if this system is essential or not, if you wear the shoes of patients, for kidney, except dialysis, there is no alternative. Many patients don't have no alternative approaches with many different diseases, including. Those are the patients, if without anything, any intervention, they could lose their life. With this innovative approach, we could have new matching, otherwise not matchable organs, kidney. We can expand the numbers of match. That will be a key step for medicine. The ambient temperature, mechanical perfusion is getting a lot of attention. These companies have been growing very fast over the last three years in the U.S. I would say we are confident this is the system technology that is essential. By combining our core technologies, we can give more value to the sales front to the patients. I have no doubt about that.
Now, a second question. If you think about the receiving side of that technology, I'm thinking about cost. Cost, and how much would you want to invest for cost for patients to decide whether they want to go for organ transplant option or not? Is that insurance covered that? Their philosophy, but many different factors. I guess your approach is you want to have marginal organs being saved up. In the next three years, before going to the marginal, you would want to match patients otherwise being not matched. That might be giving a high growth because that might be easier to be matched. You need to, in the future, expand the market. There are laws, regulations, and philosophy, religious beliefs. How can you expand the market, build more potential patients? I think this is going to be an important challenge for you in a year's time. Can you make me more confident that you can really build more potential market?
First, reality today is supply is very small versus demand. We will develop the low-hanging group. The low-hanging, but it's not low-hanging group, is going to dry up in several years because with this technology, many more lives of the patients are going to be saved. Like I said, there were a lot of patients who need to be registered but couldn't get the organs because they are cut off from the list because the problem is supply. The numbers of the transplant is 150,000 today. There are patients who dropped off from the list 10x bigger than who are receiving the organs. We can expect very fast growth for the time being for some times to come. I'm very confident about that. Thank you.
May I also add a comment on this topic? During the due diligence process that we have done, supply, we looked at the potential of supply catching up to the demand. Innovation is catching up very fast. We look at different announcements from the medical conferences. The original source of cancer has been treated. It's staying at liver, but then it can be metastasized to other areas. This technology can be very useful for that kind of patient. I think the demand is also going to be expanding once this technology gets established in a way for sure. Is this essential? Do we have to have this? It's more than patients, right? QOL for medical practitioners are very important. In the real world, six hours or seven hours is the preservation time. All the matching is taking place in the evening to night. That means they have to work, do the surgery in the middle of the night.
By stretching to 12 hours, you can do it from the morning time to evening time, the regular working hours. QOL for medical practitioner doctors are going to be improved. This is also a very important driver. I just wanted to add that comment.
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Yes, Ueda-san, please. Thank you.
Thank you very much. I'm with Goldman Sachs. My name is Ueda. Let me first ask you a question about this acquisition at this very timing. Why is that?
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According to the presentation, you touched upon the innovative aspect and the need. It's been there for quite some time. I understand the company has been doing business with Terumo for quite some time. Through Terumo Ventures, there was some investment and things that rapidly developed into this acquisition. What is the very significance of your involvement?
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Thank you for the question. We started out with the 2017 or TCV, the CV. The business has been doing business about CDI sensors. During that time, we only had a vague understanding that that kind of business existed. Just this spring, Terumo Ventures was making investments. Naturally, we took a very good look at this company. It was necessary. We rapidly deepened our understanding into the company. We found it a very nice acquisition candidate. That's why.
Thank you very much. Let me ask you a follow-on question. Your involvement in Terumo's entry and then things OrganOx could not single-handedly do, what kind of things are made possible?
It may not necessarily relate to this very timing. One of the main components has been sourced from Terumo. Regarding other components in the mid to long term, such other components could be replaced to Terumo components.
There may be other synergies. For example, post-organ transplantation, patients that need to be taken care of, for example, apheresis. It's important to put the patients on apheresis. Terumo BCT is not all into that. Terumo and this company together may produce more business to Terumo BCT as well.
Thank you very much. Regarding your future business, the market size, you talked about the organ breakdown of the transplantation. The kidney is pretty big, I understand. In terms of the number of the transplants, liver and the kidney involve different business models, or are they as big as each other?
Value-based, there's not much difference between the liver and the kidney. As was presented, liver is vulnerable to ischemia. Kidney, excuse me, the vulnerability to ischemia is so different between the two organs. In terms of value, according to our calculation, there's not much difference between the two organs. The liver will soon be bigger in a few years. The kidney transplantation count is much more. The value-based, the liver should be growing more. Basically, we try to deploy the business in conjunction with the liver. The healthcare providers, the QOL is very big. In terms of the sequence, first the liver, then kidney. Thank you very much. That's it.
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Thank you. We can take the next question, please. Tokunaga-san, you're next.
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Thank you. My name is Tokunaga from Morgan Stanley. Now, looking at the pipeline, like Metra-L and Metra-K, how long, how much additional investment are required for the launch? And then give me about how much we require and how soon they are coming launched.
I'm not disclosing the amount of investment, but the timing has been covered in the presentation. K is 2030. L is slightly earlier than that.
Okay. Understood. Distribution channel, would you make additional needs to additional make investment? Or your current distribution channel network or OrganOx distribution channel will suffice it, do you think?
Sales efficiency, distribution efficiency is very high in this. With their revenue size, they are also profitable, right? With the revenue side today. Because the U.S. is the center of the demand, they have about 150 transplant centers. There are some major big centers, top 50, I would say, transplant centers.
70% of all the transplant cases are covered by 70% of the centers. We are almost, not perfectly, but very close to 100% coverage. Once we establish that, we can just use that for kidney transplant. To leverage is going to be becoming more favorable. Do we need to have, we don't really need to double sales resources if that's your question. Also, this is an automated process. It's very non-human, manual intent, non-intensive. Thank you.
Kohtani-san, please.
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Thank you very much. Kohtani with Mizuho Securities. Let me ask you a few more questions. Austrian Metra-related paper, I've been looking at the paper. DCD, the death by cardiac death, is increasing in terms of percentages. The post-DCD organs are difficult to use. I understand there may be elderly citizens. With the spread of this kind of device, the use of DCD organs will increase to what extent? Do you have some numbers? Can you share some such numbers?
It's not about the DCD percentages, but the supply growth. That's the important thing. The brain death, I believe you mentioned 20%. DCD will more contribute to the transplants and the sales-wise at 20%. The two-digit growth will be enhanced, contributing to our top-line growth. Most of the volume zone of the market may be contributed by the DCD.
Let me also ask you about the primary endpoint. Y ou haven't produced the papers, but the pivotal study, the primary endpoint was not achieved. The cannulation and the suturing needed additional trainings. Is that tough to use? Looking at the competitors, the product study achieved the primary endpoints. Here's the difference. Could such differences be potential differences?
Certainly, the products are approved. The primary endpoint-wise, the approval was based on the positive increase of the number of the transplants. DPD-based CS patients was what it was compared against. We were slightly disadvantaged. The number of the transplants certainly increased, hence approval. There's one more thing. A closed system versus open system. Closed from the external air. OrganOx, three connections. No thrombus because of non-exposure to the air. It took some time before the surgeons got used to that. The learning curve is certainly improving. It shouldn't kick in as the disadvantage. The market share is increasing.
Okay. Great. Thank you very much.
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We can now start taking those of you who are remotely accessing. I'd like to now give a chance to Tokumoto-san from Nikko Securities to ask first online question.
Yes, my name is Tokumoto from Nikko Securities. Can you hear me?
Yes, we hear you.
Okay. Thank you. I just missed the section when you were talking about profitability economics model. Can you just repeat about projects and a wee bit of margin? Because I couldn't share that part. TransMedics, like competitors, like they have their EBITDA is about margin is 13%. So this target company, are you confident their margin can be higher than that? And competitors over the last few years, they are making profit, but the gross margin is struggling. Can you talk a little more about how confident are you how this can make a sustainable, profitable business?
I will pick up. My name is Hagimoto. I'd like to take that question. Now, as has said, EBITDA is a little high of 20%. That's where it's trending at right now. If I talk about the future prospect, like I said earlier, once the top line grows, SG&A, especially like a investment for distribution channel, incremental distribution channel, its investment will be very light, very light. Therefore, there's a scale benefit once the top line really grows. That's actually a great model. I'd like to point out as a model, like the hardware sales and the disposable sales, right? The turnover of disposable, once the top line grows, then this can give benefits on the COGS percentage. Of course, we can also bring more efficiency by mass production, volume production. From today's EBITDA, once our top line will grow, we don't think the efficiency or profitability will not go down. That's how we see it today.
Oh, okay. Understood. Related to that question, I'd like to ask you about the mid to long-term strategy. JPY 100 billion in top line is the growth ambition I think you are looking at. I'm sorry for your competitors again and again. I know they are not really the same business. Looking at their competitors' actions, they were trying to get insurance coverage in other countries. They were trying to go fast on capital expenditure in trying to get more business. I guess this business growing to ¥30 billion would be quite easy from today's stance. If you want to grow the scale faster than the competitors or go bigger, then capital investment or the cost expense investment is going to be quite sizable. Do you think assets like approachable will that change or not? I'm sorry for asking one more question.
When you are rolling out to kidney, I'm sure competitors are looking into that opportunity. I think 2030, that means that competitors are going to be launching kidney first before you guys.
I'm sorry, I'm randomly talking a few questions. Your question about manufacturing is more in ears. We will first make sure business is growing, right? We will keep an eye on before deciding where to make a capital investment on. We will work closely with the top management of OrganOx to discuss where and how we are going to be making a big capital investment for building capacity. Now, Terumo, one of the benefits that Terumo can provide is that we already have in different kinds of markets in different regions. We have, of course, 30 factories. If we can use those facilities, then that's a synergy that we could demonstrate and enjoy.
We will take that as an option. If necessary, manufacturing engineering is something we can learn each other, jointly work together with. CDI might be the only one component that we have started out with. Like Samejima-san has said, we can go, you know, whether synergies or manufacturing joint work is where we can demonstrate more opportunities in production, manufacturing.
Can you talk about kidney?
No, I cannot make a comment that can make or break, you know, about our technology roadmap. You might think competitors may come launching kidney solutions before us. There's not much of difference, though. That's all I can say. Once we are ready to tell you more about it, I can come back to this point.
Oh, okay. Thank you very much. That is all from me. Thank you.
[Foreign language]
Thank you very much. Macquarie Capital. Tony-san, please.
Hello. Can you hear me?
Yes, we can hear you well.
Okay. Perfect. Yeah. Thank you for the opportunity. Just two questions from me. The first one is about the synergies again. Listening to your presentation and reading your slides, it appears to me that most of the synergy appears to be in the Terumo Blood and Cell Technologies and possibly with the Terumo Medical Care Systems. I just want to understand whether you see any synergies with the CMV business as well, and whether the synergies will be on the revenue side or the cost side. That's my first question. The second one, I know it's not related to the OrganOx acquisition, but I'm getting a lot of client inquiries about the A-size Lacombe auto injector. The PDUFA date is only two business days away. I'm just wondering if you have anything that you can comment on that U.S. FDA PDUFA date. Yeah, thank you.
Okay. Let me answer to your question. Yes, definitely there is a synergy with a TCV company as well because we've been supplying kind of a key component of the Metra system for a long time. We found that there are other components possibly replaced by our own products in the mid-term and long term. There is a synergy with TCV, Terumo Cardiovascular Systems business. That's synergy in TCV side. Your second question, I would say, I'm sorry, but it's irrelevant to this kind of the session. I would just preserve that kind of answer to you.
Yeah, understood. In terms of synergy, do you see them coming from the cost side or revenue side?
Yeah. I would say, you know, I would say both because, for example, the kind of post-procedural care, patient care includes apheresis. I mean, that's a critical kind of, you know, the post-procedural care for the recipient. BCT obviously has a very limited market presence in that particular segment. I would say that there is a possibility for BCT perspective to find a new business opportunity, you know, in that segment. That's kind of top line-wise. Bottom line-wise, of course, as Jin Hagimoto mentioned earlier, we do have a strong operational footprint on a global scale. In the long term, of course, we need to discuss with the management of OrganOx. From operation, including manufacturing, we do have a possibility to pursue some cost synergy opportunities as well.
Okay, great. Yeah, thank you very much.
[Foreign language]
Thank you.
[Foreign language]
Markus-san, go ahead.
Jeffrey Schulke and Steven Barker.
Steven Barker from Jefferies Securities. I want to talk about the economic model. TransMedics, looking at the economic model, service is actually a big contributor to that profitability. In OrganOX, hardware, software, and there are some, does it also have a service revenue? For hardware, is this hardware being sold to hospitals, or is this business model slightly different from that?
Disposable.
Disposable, generally speaking. Very close, similar to Metro.
What about services?
They have an end-to-end business model. The model approach is slightly different. Services, we are not expecting many revenue from services. Okay. Thank you.
[Foreign language]
Thank you very much. Any other questions?
[Foreign language]
Watanabe-san, please.
Oh, thank you very much for the presentation. I've been with the securities. My name is Watanabe. Regarding the management, I understand the founder has been with the Oxford. It's going to be your subsidiary. What kind of management will be installed from Terumo? What kind of monitoring of the company? Do you have some input to provide? CEO.
CEO.
I mean, is a separate person than two founders. Currently, regarding a key management personnel, they're going to stay with OrganOx. It's been confirmed. On top of that, from the governance perspective, the board members and the local presence of Terumo personnel, we're considering that so that periodically, they and we can conduct business discussions and also have business discussions with them. We're trying to structure the business.
[Foreign language]
Thank you. As to let Yoshihiro-san, who are coming online from Nomura Securities Value Investment.
Yes, thank you. Let me ask you one question. Now, transmission cost is quite substantial, and there are maybe, did you have any other potential candidate buyers? The other ones, like Terumo Venture, had made this investment. It was quite quick, very fast before you make that acquisition investment. Back when the Terumo Venture was investing, right? In 2020, I think you established Terumo Venture. Do you think Terumo Venture's presence was a very important point in coming to deciding this acquisition? That's my question.
My first question is very sensitive, so let me refrain from answering the first question. To your second question, the project deals of Terumo Venture making an investment, and that was being proposed to top management. That helped our understanding about this business. Speed, I've been saying this many times.
We are not going to be without courage. Very fast, we'll decide if there's a great deal out there. This is a great opportunity that came to us. Thank you.
[Foreign language]
Thank you very much. Any other questions? Yes, please.
[Foreign language]
Thank you very much.
[Foreign language]
My name is Hidemaru Yamaguchi. Saving the cardiac arrest is important that you mentioned it. Let me ask you a question. In the U.S., where do people have a cardiac arrest accident or in hospitals? Where do they get a cardiac arrest? When that happens, what is the best way? Who does what? Currently, are they taken by ambulance, or what is the optimal place to install the device? Should it be installed in the ambulance or installed in the hospitals? Where is the best place? In terms of transportation, it means that there are two. Were the donors or emergent?
They cut it down and they transport if it's a short distance. NMP can be in the hospital back to base. That is where it can be pursued. The organ functions may be picked up with better perfusion and implanted. That is the particular characteristic of the OrganOx device.
That is about the short distance. If it's a long distance, the organ needs to be maintained in the device and transportation to maintain the function. It depends. I can't talk too much about the competitors, but the competitors address the DDD. The organs are put on the NMP device. In the case of OrganOx, there's a flexibility with lower cost. A flexibility, therefore, low cost. We can further check the response and respond. The U.S. is pretty much advanced. For example, who are listed as donors? There's a good database. Say the traffic accidents or gunshot death, then they come in quickly. There's the organ harvesting organization. They get immediate notice. Information on is applying a U.S.C. pretty much advanced.
Thank you very much.
Thank you. Any other questions?
I just have a question.
Yes, please go ahead, Yoshihiro-san.
I apologize. Maybe I should have known this better. One additional question. Hospitals in the U.S., are they very careful managing their costs right now? Do you have any qualifiable information?
Insurance, motor insurance are private, right? If the procurement cost is cheaper, then it helps hospital economics. Cost differences are very important, which is an advantage for this technology. Their attention to economics is very important. That's one of the advantages that makes it more favorable to organ technologies.
[Foreign language]
Thank you very much. Any other questions?
[Foreign language]
Yes, Sato-san, please.
[Foreign language]
Let me ask a couple of questions.
[Foreign language]
Regarding this business,
[Foreign language]
Is there a lot of seasonality? I'm under the impression that there is a seasonality based on the competitive business. Your business has been pretty stable across all seasons. In a few years to come, I understand that this business is expected to be pretty profitable. I just wonder if this particular business may go up and down depending on the seasons.
This is early on. In the most recent two years, the 20% growth has been achieved. 20% and then 20%. Seasonality, positive or negative, we don't know as of now.
Okay, thank you very much.
[Foreign language]
Any other questions, please?
[Foreign language]
Yes, Kato-san.
[Foreign language]
Yes, I'm Manus Kato from Daiwa Securities. Thank you for this opportunity. At the end of the presentation, CEO Yu talked about your confidence that people will look back and approve this. Can you talk about what makes you so confident about it with specific examples?
In the process of selecting target companies, five criteria have perfectly been met. I've been in this industry for many years. I've been in more than hundreds of the target potential companies. It's very rare to find they all have all the checkbox being checked. That is the biggest reason why I'm so excited about it. Thank you.
[Foreign language]
Yamakita-san, please.
[Foreign language]
Thank you very much. I'm with Jefferies Securities. Let me ask you one confirmatory question regarding a transplantation that's around the clock and it takes long hours, so much burden on the healthcare providers, and the number of the surgeries may increase. What about the surgeons' capacity? Any concerns that there aren't enough surgeons?
Thank you very much. Based on the NMP numbers, it can start at 6:00 A.M. to 3:00 P.M., but that's a typical day. If more time is necessary, it may exceed the surgeons' capacity. We need to further watch out for that.
Okay, thank you.
[Foreign language]
Thank you. Any other questions? Yes, Katanisan, please ask.
[Foreign language]
Yes, Kohtani from Mizuho Securities. I guess there are champion data that shows three days or 10 days where there's a few cases have preserved. Do you want to stretch the preservation time as long as that? Maybe too premature. I mean, 12 hours. 12 hours can help QOL business practitioners. Can you, I mean, yeah, we can maybe come back to that in the future. 12 hours is regulated time in the U.S. It can go up to 24 hours eventually. Are you going to be submitting for that?
12 hours itself is very valuable. We will make it to 24 hours eventually. It doesn't really make that any big difference, even at 12 hours.
I'd like to ask just one last question. You look at many potential targets, sequence for Microbench and Reseal. You have been observing that. Compared with all those transactions versus this one, how excited are you in comparison?
Let me just, you know, I'm not going to give ranking, but the levels of excitement is very high, for sure.
Okay, fair enough. Thank you very much.
[Foreign language]
Thank you. Any other questions?
[Foreign language]
If none.
[Foreign language]
Thank you very much. This officially concludes our explanatory briefing. Thank you very much for your participation despite your busy schedule.