Olympus Corp Ord

Hello everyone, I'm Stefan Kaufmann, CEO of Olympus Corporation. I would like to thank you for participating in this conference. Fiscal year 2024 provided us with numerous challenges. In this environment, our organization and people have proven to be resilient, our business model to be robust, and our relationship with our customers to be stable. For fiscal year 2025, we are confident that we will see a strong recovery bolstered by the significant potential of our strong business model and our grown self-confidence to overcome obstacles. Our purpose and refreshed core values, the three strategic guiding principles of patient safety and sustainability, innovation for growth and productivity, And the four value pools build the foundation and define the direction for sustainable growth in the future. As introduced in our company strategy and in relation to our first priority, patient safety and sustainability, we are implementing numerous initiatives to strengthen our QERA system, processes and capabilities over the three years from fiscal year 24 to fiscal year 26. So far, we have made great progress. To give you a few tangible examples, in fiscal year 24, we undertook several initiatives to improve our ability to perform root cause analysis, which is central to our efforts to create the most effective corrective and preventive actions. We have also improved our complaint handling effectiveness, resulting in more consistent medical device reporting and even quicker responses to patient safety signals. Also, our regulatory compliance functions have enhanced their operational impact significantly. The EleVIT program will help to unleash Olympus' full potential, improving our sustainability and creating a strong backbone for future innovation. We have successfully put in place stepping stones for future growth, A solid pipeline of growth drivers in our defined clinical focus areas is in place, and we are leveraging our value pools. With those in our proven business model, we anticipate a strong recovery and more stable operations overall in fiscal year 2025. We have identified strong opportunities across our value pools. With its release in the US, our flagship, EVIX X1, sees a very high demand. In addition, our broader GI portfolio shows significant growth momentum in North America. The emerging markets show relevant growth opportunities and high future demand. Also, our pipeline features relevant care pathway extensions. For example, we are very proud of the recent clearance for our first single-use ureteroscope, Renaflex. And there's more to come. We are excited that our intelligent endoscopy ecosystem should start to see its first releases in Europe in the second half. Let's now have a look at those value pools in more detail. Since the introduction of EVIS X1 in the US last October, our GI endoscopy business gained strong momentum and grew 20% year-on-year in North America after FX adjustment. The latest order situation is very favorable, and we expect high growth in fiscal year 25. As you might be aware, the North American market accounts for about 35% of our total sales in the GI endoscopy segment. Also, our GI endotherapy business has been a strong performer. North America accounts for about 25% of our total sales in this segment, and has been growing at a double-digit year-on-year rate for the last two years. We had strong growth from all three core clinical areas, colorectal cancer detection, colorectal cancer treatment, and HBP diseases. The Colonoscope Distal End Detachment Endocuff Vision and the Hemostasis Powder Endoclut are two of our uniquely differentiated products that are high growth drivers, especially in the U.S. ESD knives and ERCP devices, such as Multi-3V Plus Extraction Balloons, show repeated double-digit growth. We will continue to focus on these business areas and capture further global expansion opportunities. Wherever I meet customers in the world, their feedback about EVUS X1 is overwhelmingly positive. Dr. Saruja, a U.S. clinician, claimed that the EVUS X1 enables visualization that we did not think possible, supporting safe, efficient, and high-level care for our patients. The X1 endoscopy system is our most advanced system. It introduces several easy-to-use technologies that aim to revolutionize the detection, characterization, confirmation, and treatment of gastrointestinal disorders. The imaging advancement, including TXI and RDI, improve the quality of endoscopic diagnosis and treatment. A recent article in the endoscopic journal Gastroenterology demonstrated the clinical value of TXI and concluded that TXI improves both the adenoma detection rate and the adenoma per colonoscopy. To date, this is the first randomized controlled study using TXI during colonoscopy and highlights the potential benefit of more widespread uptake in enhancing the quality of colonoscopic screening and surveillance for all patients. We are excited to continue elevating the standard of care with EVIS X1. Another growth driver and opportunity for global expansion is the emerging markets. In emerging countries, demand for medical equipment is expanding due to quickly growing populations, lifestyle changes resulting from rising incomes associated with economic growth, and the expansion of medical infrastructures. The need for gastrointestinal endoscopy, which contributes to the early detection and treatment of GI cancers, is increasing as the incidence of cancer is expected to rise in the future. Conversely, emerging countries are facing a shortage of highly specialized endoscopists. Therefore, we will strengthen our investments in training activities for endoscopists in emerging regions such as Africa, India, and Latin America. Although emerging countries still account for a low percentage of our total medical business sales, our CAGR over the past few years have been very high at 20% and more, and we expect continued high growth in the future. In addition to many opportunities for business and global expansion, we are progressing in our care pathway enhancement efforts. As the leader in endoscopy, our goal is to provide the right scope for every patient, procedure and site of care. The 510K clearance for Renaflex, our first single-use endoscope, is therefore an important strategic milestone for us. Renaflex will complement our innovative portfolio for endoscopic stone management procedures, which are in growing demand due to increasing prevalence. It will allow customers to optimize workflows, for example, in case of unexpected events where reusable ureteroscopes may be unavailable to avoid cancellations or delays. Featuring the ergonomic and visualization capabilities for which Olympus is renowned, RINAflex is scheduled to launch in the US and APEC during fiscal year 2025. Another important value pool for growth is our vision of the intelligent AI-driven endoscopy ecosystem. We are very excited to bring this vision into reality. The feedback we have received from our customers is very reassuring as we are able to address many of their currently unmet needs. The ecosystem we build is not limited to software products but includes endoscopes, infection prevention solutions, services and integration with multiple hospital systems. We aim to leverage the power of data and AI to improve clinical outcomes and efficiency. Customers subscribing to our intelligent ecosystem will find multiple artificial intelligence algorithms developed to improve their clinical outcomes as well as solutions to improve their workflows, gain insights into their clinical performance and manage their endoscopic assets. The initial solutions are co-created with five hospitals in Europe and we expect to open an additional 10 reference centers by the end of 2024. Let me close with emphasis on the fact that we expect strong recovery in fiscal year 2025, both in sales and profit. Obviously, some of the growth is supported by exchange rates effects. But even without these tailwinds, we will make significant progress towards our targets announced in May 2023 of revenue CAGR of approximately 5% and 20% operating margin. And now, you might be curious to meet our new CFO, Tatsuya Isumi, who joined us at the beginning of April. Please give him a warm welcome. The stage is yours, Tatsuya. Thank you, Stefan.

Hello, everyone. I am Tatsuya Izumi. I was appointed as CFO this April. I am proud to bring my extensive experience in the financial field and global business to Olympus. By actively engaging in dialogue with external stakeholders, I hope to contribute to further strengthening Olympus' corporate value. Your support is appreciated. I would like to provide our consolidated financial results for fiscal 24 and the full year forecast for fiscal 25. These are the highlights of the fourth quarter and full year results for FY24. In FY24, we achieved increased revenue on constant currency, despite headwinds such as decreased sales in China, the Noto Peninsula earthquake, and temporary shipment suspensions of some products. On a reporting basis, the medical business achieved a record high for both the fourth quarter and the full year. Operating profit and adjusted operating profit decreased due to several one-time expenses. Total profit, including both continuing and discontinued operations, reached a record high of 242.6 billion with EPS of 200 yen due to a gain on the transfer of scientific solutions business evident recorded in the first quarter. Next, full year forecast for FY25. While FY24 posted a decline in OP due to multiple one-time expenses and other factors, FY25 expects a return to a growth trajectory and to achieve a revenue of $1,021 billion, up 9% year-on-year on a reporting basis and 5% after exchange rate adjustments. OP is projected at 177 billion, marking a significant increase driven by a higher revenue and lower one-time expenses, coupled with a favorable impact of foreign exchange. A significant increase expected on constant currency as well. Adjusted OP is projected at 198.5 billion, up 31% year-on-year on a reporting basis, and up 22% on constant currency. Adjusted operating margin is expected to be 19.4%, close to our financial guidance in company strategy of 20%. We project profit of 121 billion with EPS of 106 yen on an absence of gain on transfer of evidence in the previous year. Dividends for FY25 are forecasted to be ¥20 per share, up ¥2 from the previous year, in light of the financial forecast under our policy of stable and gradual increase. As announced in a timely disclosure released today, we have decided on a share buyback of ¥100 billion, marking this the second consecutive fiscal year to execute share buyback. Now some details of the results for FY24. Consolidated revenue amounted to $936.2 billion, achieving increased revenue on constant currency with strong performance in North America and APAC. Particularly in North America, we are seeing momentum building up led by EVIX X1 launched in October of last year. In the meantime, sales in China declined due to a significant impact of purchases decisions to delay tenders as they managed the effects of the anti-corruption campaign in various segments. Gross profit was 625.1 billion with gross margin deteriorating 0.9 points. due to an expense of approximately 5.2 billion for the field corrective action for a high-speed encephalator and provision of approximately 4.2 billion for the voluntary recall of small intestine endoscopy system and others. SG&A expenses were 473.2 billion with SG&A ratio deteriorating 2.9 points. Major factors include an increase in expenses related to the Elevate program and expenses for improving efficiency and strengthening of operational infrastructure for sustainable growth. OP declined to $3.6 billion, down 77%. The open margin deteriorated 16 points to 4.7%. Regarding other income and expenses, a loss of 108.3 billion was posted. Major expenses include about 51.9 billion for the discontinuation of manufacturing and sales of electromagnetic navigation systems and others by Varon Medical. about $23 billion related to the Elevate program, about $8.6 billion for losses related to orthopedics business, and about $10.6 billion for impairment losses on the development assets and work-in-process R&D projects in ESD. Expenses related to Elevate Program totaled approximately $31.5 billion, with approximately $8.5 billion under SG&A and approximately $23 billion under others. Adjusted OP declined to $151.5 billion, down 14%, with an adjusted OP margin deteriorating 3.9 points to 16.2%. Profit from continuing operations was $27 billion. With the completion of the transfer of discontinued operation in April 2013, we recorded a gain on the transfer in the first quarter. Total profit including both continuing and discontinued operations was ¥242.6 billion with EPS of ¥200. We plan to pay a dividend of ¥18 per share for FY24 of ¥2 year-on-year as announced previously. I will not touch on details by segment, the consolidated statement of financial position, or the consolidated cash flows. Please refer to the presentation with script available on our website for details.

This slide shows the factors that affected operating profit compared to the forecast presented in February when we announced the third quarter results. Although the impact of the Noto Peninsula earthquake was smaller than expected, we recorded additional expenses in other expenses, including losses related to the orthopaedics business and impairment losses on development assets and working process R&D projects in ESD. This was because those assets and projects were reduced to their recoverable amounts to reflect changes in the market environment and other factors that made it impossible to achieve the expected revenues. Although these expenses have not been factored in as of February 14th, when the third quarter results were announced, we believe that we need to make improvements to enhance the accuracy of budgeting and forecasting, and I believe that this is my personal obligation. Next, I would like to explain our full-year forecasts for fiscal 2025. As Stefan explained earlier, we view fiscal 2025 as the year in which we return to a growth trajectory, expecting top line growth of 9% on a reporting basis and 5% after FX assessment. In addition, as we completed the process to eliminate future concerns in the previous fiscal year, one-time expenses that had large toll on the previous year's results are expected to decrease, and with a tailwind of FX pushing the revenue, we expect a significant increase in the operating profit, also expected to increase significantly after FX adjustment. Adjusted operating margin is expected to be 19.4%, close to a financial guidance of 20%, indicated in the company strategy. Lastly, I would like to explain our capital allocation. Our capital allocation policy remains unchanged. Strategic investments in highly profitable exiting businesses and growth opportunities will be given top priority in allocation, and shareholder returns will be based on stable and gradual dividend increase. We will consider share buyback when there are surplus funds available after securing sufficient liquidity on hand for working capital and investments. As announced today, we have decided on share buyback of 100 billion yen. Based on our capital allocation policy, this will be share buyback in the amount of 100 billion yen for the second consecutive fiscal year, while securing sufficient liquidity for working capital and future investments. The annual dividend forecast is 20 yen. Going forward, we continue to allocate capital to ensure stable returns to shareholders with top priority being placed on business investments that increase shareholder value. This concludes my presentation. Thank you for your attention.

We will now move to the Q&A session. Slide 42. the variance analysis for the operating profit for FY25. I understand that others will decrease. from 88 billion what are the likelihood of achieving this other expenses or one-time expenses increased quite a bit especially compared to the forecast for february but for the next fiscal year for fiscal 25 you are are projecting a large decrease. Is that because you have a system in place to control the long-term expenses? In other words, you feel that you have a better visibility?

Thank you very much for your question. He has done an amazing job just within six weeks to deeply understand our business and our numbers, so I dare to transfer this question to him.

Thank you for your question.

True. We have made lots of downward revisions in the past, so I can understand the reason why you doubt. our ability but looking at the current asset or business situation i don't see any reasons for a large loss going forward during fiscal 24 given that it was the first year under the leadership of Dr. Kaufman, lots of actions were taken to eliminate those debtful assets. So right now we don't see any suspicious assets and this is also my responsibility as well to have a better visibility and I'm already seeing Improvement. We can't commit to this, but I am confident that we can achieve improvement. I hope that answers your question. Thank you. One follow-up question. So, conversely, I know you've been in office for a very short period of time, but what do you think were the negative factors in the past. In other words, what do you think you need to focus to ensure improvement? This is a question for Izumi-san. Well, it's very hard to give you a very specific answer at this juncture, but there are two things. One is M&A governance on mergers and acquisitions. We want to set up a committee to enhance this under the Chief Strategy Officer, Gabriela. So we are enhancing that capability. Another is the better communication internally for information. not just on the CXO basis. For each division, we have excellent talent, but when it comes to the inter-divisional, inter-functional communication, I think there has been room for improvement. So by addressing that, I think quite a bit of the negatives could be addressed. That's my projection now. Thank you very much.

I have one question. I may have missed this, but expense for Elevate for this year, how much is it expected at for this fiscal year? And how is it different from what you had estimated in the past?

I'll take this question and then maybe Isumi-san can support me if my answer might not be sufficient. So when we announced in May 2023 our transformation and remediation program, at that time it was not called yet Elevate, we estimated the total cost to be in the corridor of 60 billion yen. I think in the earnings call for the second quarter results, I received a similar question. Do we believe that this cost will remain in this amount? And my answer was plus minus 10%. And that answer remains true until today. What has come, unfortunately or fortunately, depends on the perspective you take, is the currency effect. So on a sales perspective, we are very glad about the currency. Depreciation on a cost perspective, the currency depreciation of the yen leads to higher costs for us and this is also an implication on the Elevate program. So I believe at the end of this period we will be above the 70 billion yen amount for our remediation and transformation efforts. What is important to understand is that fiscal year 24 and fiscal year 25 is very much focused on remediation activities, and we will close our remediation activities in fiscal year 25 and focus then more on transformation, which we do in order to gain a competitive advantage by being a company that puts quality first and has a strong patient focus in all our activities. So that means after fiscal year 25 we will focus more on transformation and less on remediation because our remediation activities have been close to that stage. To answer your question concretely, I think in fiscal year 24 we had around 315 OCU. as total cost for our remediation and transformation activities. And I think the cost for fiscal year 25 are in a similar range of 320. Thank you very much.

I'm sorry to be technical, but how does it split between operating a profit versus others?

Well, rule of thumb has not changed so much. So basically, one-third we see in the operating income, two-thirds we see in other expenses. And the rule basically is everything which is one-time effects, which are related to remediation and costs that will go away, are booked under other expenses, while those costs we build in order to mature our organization, our systems, our processes are booked under SG&A.

So after 25, one-time cost will be basically very small, but there's no additional increase of increased part for the OP part. Is that correct?

That question is not so easy to answer. So basically what we have focused on the last one and a half years very successfully is to progress in our remediation. And there the progress is really great. We have also enhanced capabilities in many areas that help us to become more productive, more efficient, but also help us in innovation and in our manufacturing processes. What the job for the next one and a half to two years is to look forward and design the quality regulatory organization we need in order to sustain the level we have accomplished. And this will then basically be the future cost of our QARA organization. And at the moment, my expectation is that we will be best in class compared to our peers because we use at the moment a lot of the investment also to bring in technologies which will help us to build up an efficient organization. But it's too early to give you a definite answer already now what the cost for QARA in fiscal year 26 will be.

Thank you very much. Understood.

I think it was 85 versus 230, the Elevate SG&A and others. Can you give us the similar breakdown for this fiscal year? And I'm looking at page 42, others improvement, a large improvement. It looks like elevate expenses itself would not change much. I suppose impairment loss would be decreased quite a bit. And looking at slide 40, in Q4, something new, quite a bit of something new were added. which gives us a suspicious as to whether this would not be repeated this fiscal year. Again, in the Fourth Court, Taewoon, Veyron, and then there is orthopedics as well. So why is it that in FY24 you had so many impairment losses and you are so confident that this would not be repeated in FY25? That's my question.

I think this was directly a question to you, Tetsuya, so please.

First, your first question, and it elevates FY25. SG&A, 12.4 billion and 19.3 billion for others. That's for FY25. This corresponds to what Stefan said earlier. So, impairment losses. Would there be no impairment losses this fiscal year? In other words, All we can say now is that we don't see any reasons for impairment losses as of now, but economic situations would change, so we can't say that it would not happen. We can't commit to no impairment losses, but what is visible to us now, the factors where we should expect impairment losses, we don't see any of those as of now. That is all I can say for now. Impairment losses, yes, for March 24, there were quite a number of them. So can you say that you have sort of exhausted them all? Why is it Taiwu-Veron Orthopedics? I think this is HS Ortho. Why is it that you had recorded so many of them in the fourth quarter of FY24? The way I see it, it just so happened that that was the case. But the policy of the company is that if there are any concerns, we should proactively address them. That, I think, was the policy. That was a message from Stefan. So for FY24, there were many challenges and therefore we should get rid of the suspicious ones as much as possible during FY24 so that we can make a clean start in FY25. I think that was a sort of a message from Stefan. Very clear. Thank you. Another factor, if I may. The backdrop, and I guess this is true for Tewu. Patient focus is our core value. So in that sense, we want it to be conservative on many fronts, given priority to safety. the patient first policy. I think that was also a factor to be taken into consideration. But that's just my guess because I've been with the company only since April. So this is a third of a third party view.

I would like to supplement the answer from Mr. Moussa because maybe indeed not easy to answer for him just being with us for six weeks. So I think I can derive two reasons why you find so many impairment losses in fiscal year 24 and why we are more optimistic that in fiscal year 25 there will be significantly less. The first one is fiscal year 24, that was the starting point of our remediation activities and obviously in the first year we have found a lot of areas where we felt that patient safety could not always be secured and this has led to decisions which in one or the other case has triggered an impairment on a company or on an asset or on a product. That's the first answer. The second answer is that we understand that in fiscal year 25 we have provided you one or the other time with surprises and our intention for the future is to eliminate all surprises and become reliable in our forecasts and our predictions. with the connotation that we all live in a world of uncertainty, in an environment that is highly volatile, and that we are still in the process of remediating and working on the findings that have been identified during the inspections of FDA. But having said this, we believe that in fiscal year 25, it will be much more reliable in our forecast than we have been in fiscal year 24, because we have more stability and we also take a stronger and more rigid lens on our business risks.

I have a question about ESD, China, anti-corruption campaign. In FY24 second half, starting from second half toward FY25, what kind of improvement momentum do you see in relation to anti-corruption campaign? And if possible, please share with us how the bidding process is improving and what the competitive landscape looks like. That's my first question. Thank you.

Thank you for your question. Maybe I can give a general answer about the situation in China, and then I would ask Frank to answer your question from an ESD perspective. So first of all, our stance towards China has not changed. So we do see midterm huge growth potential in China for Olympus. because there are significant unmet needs and we believe that we as a company are very well prepared to improve access and outcome in healthcare in China. Because we have a long-lasting history in China, we have a very strong installed base and we have long-lasting relationships with our customers. So our general viewpoint on China remained unchanged. We do believe that China will provide us with significant growth opportunities. Fiscal year 24 has been difficult for us because we have seen impacts from buy China, from value-based purchasing, but obviously also impacts from the anti-corruption campaign. And we do expect that this will also carry forward for the first couple of months of fiscal year 25. Nevertheless, also in China, like the entire company in fiscal year 25, we have the strong intention and the plan to return to growth. And before I have covered all the topics, I now hand over to Frank to specify a bit on ESD and give you some more insights on the business situation in fiscal year 24 and what we can expect in fiscal year 25.

Yes, thank you, Stefan, and thanks for the question. I think I've covered already the more overall climate there. You also asked about bidding process and competition. Let me dive a little deeper on the point of the competition, because what we obviously see with the Buy China policy is that we have a tendency to struggle in some tenders as a non-Chinese company. And as we have explained and announced earlier, we are ramping up our production manufacturing capabilities in China as well to be able to be more competitive in those situations. The anti-corruption campaign was and is very difficult to predict in its length and its impact on our sales numbers. The hesitation with many customers to actually go forward with investments is still there. We were hoping that this would reduce its impact already earlier this year. We are now, as Stefan pointed out, predicting that this will only really ease around the second half of this year. And that is something that obviously impacts everyone. That's not an Olympus or ESD only impact. There are more, as we all know, more geopolitical and China economic question marks at the horizon. But as pointed out already, we have intensified our teamwork with the Chinese management team. And we are confident that with the growing demand for endoscopy in general, we will go back to a high single digit growth. Hopefully already in the second half of this year, but that's definitely our midterm ambition. And we are gearing up all our capabilities to get there.

Thank you. Another question I have for you, Frank, is about your outlook into FY March 2025 period in the US, in ESD. You ended up your business in the US with 2.4% growth worldwide. I believe it was a constant currency basis. How much growth would you like to expect for the new year, given that you are bringing the new system called X1? And also, if we just look at your FQ4, it was growing by 12%. So I just would like to know, better understand what could probably be the better estimate for your US ESD risk. Thank you.

Yeah, thank you for the question. And many of us have just returned from the American national sales annual kickoff meeting. And we were happy to report that there has been a very positive atmosphere and a high motivation level. The numbers of last year, especially around the X1, have been in the last two months impacted by the Noto Peninsula situation. So we have to be a bit careful in taking the 2.4% for face value. The expectation in simple terms, also adding additional products to the X1 lineup, because as we all know, the X1 processor, the box is launched. But the number of scopes that are being launched from the new generation will now steadily increase over the coming months. So our expectation for ESD in total for America is in the range of about 7% for next year. and year-on-year level. So we are quite optimistic and bullish with the American market. And as it was pointed out on one of the slides from Stefan, it's still with 35% of our global turnover, the biggest market we are taking care of.

Just to clarify that number, you said plus 7%. Thank you. Thanks so much.

My first question, the full year forecast operating profit variance analysis, slide 42. It's GNA. It's 12.7 billion. And so we need to subtract the impact of foreign exchange, of course. Is there a likelihood of upside or downside in this projection for SG&A expenses? Is there any buffer to address that gap? I understand that currently you're not foreseeing any impairment loss, but I think SG&A expenses had been a big factor in the gap in the past. So I'd like to know how sure you are of the SG&A expenses forecast for this year.

Well, then let me start to answer the question, and if Yusumi-san has something to add, please supplement. So basically in this budget fiscal year 25, there's no buffer built in, but it's also a budget where we believe that it's realistic to achieve. So I think it's a good balance between the opportunities and risks we see in fiscal year 25, and that applies to the top line and that applies also to the bottom line. The bottom line sees two different trends caused by the SG&A. One is that we have increasing cost, obviously, for Elevate, for building up our QRA function. At the same time, we have initiated a couple of cost containment programs for business support functions. You might have seen also that we had voluntary early retirement programs, not only in Japan, but also in other regions. And this will give us some release on the cost. And all in all, we want to improve our SG&E ratio significantly to fiscal year 24. But we also have to take into consideration that we are in the remediation, that we are building capabilities in QRA, but also in other areas. And we have to find a wise balance between areas where we think that we have room for improvement and other areas where we believe that we need to invest and build capabilities. So long answer to your short question, short answer now, I believe that the SG&E you find in our fiscal year 25 are realistic and achievable, but not without effort.

I have many things to add. I have many things to add.

I don't have much to add, but regarding SG&A, the strengthened control by the company is to show effect. So I believe that this is controllable. That's the way I see it. Thank you. Related question. Earlier, You talked about the control and you said that you do see the effect. And you said that impairment loss is not being projected. So in terms of the measures showing effects, could you elaborate on that? Do you have a better line? Do you see more control on the front line? Can you elaborate on the things that you are implementing this year? Again, that's a difficult question to answer. The effect. You know, in everyone's mindsets, not just under CFO, but in business, in strategy, in all organizations, when I talk to them, everybody is aware that the numerical control is one area that we need to improve. And there is a mindset to address that. Another thing... We have a deputy CFO to control this under me, and he has better contact with relevant organizations. I have a confidence there, but as for what message I can send to the market, I'm afraid I've been in this position for still a very short period of time.

I want to add from my side what we also have done for fiscal year 25. We have further clarified budget responsibility and accountability. You know that one of our core, refreshed core values is impact. And that goes hand in hand with accountability. And we have linked budget responsibility also more with the performance management and the MBO system than we have done it in the past. So we believe that this will be all important changes in order to improve our scrutiny and control of cost.

I have a question about the forecast of the expense for Elevate. Earlier, you answered that in total, it would be about 70 billion yen. And last year and this year, you have accounted for certain amounts. And that means in FY26, this expense will be much, much smaller. Is that the correct understanding? And also, the original plan was three years program. So does this mean that this program will be completed by the end of the next fiscal year?

Thank you so much for the question. So the first one I can answer with a simple yes. So we expect that cost for elevated fiscal year 26 would be lower than it has been in the years fiscal year 24 and fiscal year 25. The second question is not so easy to answer. Elevate consists of two parts. One is the remediation. Remediation means that we fix the issues that have been identified by FDA and which resulted into the three warning letters we received. As soon as we have fixed these issues, we will be ready for a new inspection by FDA and then hopefully we will be able to lift the warning letters. We expect that we have done the remediation work at the end of fiscal year 25. that does not mean that our transformation stops because transformation is much broader than remediation and that's one of the discussions i'm having at the moment with fda and and and the leadership team so to be compliant with regulations does not mean that the company is already patient focused and has a quality first mindset. And our ambition is that we become a company that is not only compliant, but that has a true quality first and patient focused mindset. And obviously, there's much more to do than just to fulfill regulatory requirements. And we are working on this in parallel to the remediation already now. But this will be the focus theme of fiscal year 26 and most likely also beyond because I don't believe that this journey will be ever over. I hope that clarifies your question. But that does not mean, last point, Last point, that does not mean that we need extra dedicated budgets for this. So this will be part of our normal operations and of our normal improvement processes and of our cultural change journey.

Thank you. One follow-up question. So, progress about addressing the warning letter situation. What is the current status? Can you please update us? When do you expect the next inspection by FDA? Do we see the end to this remediation? Has there been any progress?

Yeah, so obviously I'm tempted to answer that question because I've been so much involved over the last one and a half years, but I would like to give our new QARA head, Boris, the opportunity to introduce himself to you because last time there was no question about Elevate and he was joining without having the opportunity to speak up. So Boris, over to you to answer this question.

Hi, thank you, Stefan. Thank you for your question. It's very hard to predict when the FDA will come in, but what we're saying is that we're completing our remediation activities and they're targeted to be completed by the end of this year. We are working and meeting very closely with the FDA on a monthly basis. We're providing updates to the FDA so they have very clear visibility of our progress. and the changes that we're making to our quality system. But we do expect that once we complete our remediation activities, the NFDA would come in to inspect our facilities And with the expectation that we can demonstrate that the improvements we're implementing are effective, efficient, and are fulfilling obligations, and will allow us to form some supporting barriers. But it is, as Stefan mentioned, it's very hard to predict the specific timelines and dates.

My first question, very simple, for Endoscopy Solutions, FY25, revenue projection by region for EDS overall, 6% on constant currency basis, revenue increase of 6%. Can you break down by region? I think this will be a question for Izumi-san.

Good question?

Or shall I do it? Is it we disclose? We don't disclose the number for the region by region.

Yeah. So let me give you a very general answer. So we see growth in every region. The growth differs between 10% and 9% in the bandwidth, depending on the regions.

For ESD, on constant currency, I think 6% is the projection. So on a local currency basis, what is the projected growth by region?

I think on that detailed level, usually we do not disclose the growth numbers in our plan.

Got it. Thank you. Then I was meaning to ask about China as a follow-up question. So you said... High single-digit growth was expected in the second half of the year, but there is a pent-up demand in relation to anti-corruption campaign, and I think there has been a policy to promote the purchase So maybe we can expect a further growth in revenue in the second half of the year. So what is your view on that?

So the policy you are referring to, unfortunately, will not apply to us. So our product portfolio is not part and not covered by this policy that is encouraging big capital investments for hospitals. But again, to answer your question as precise and concrete as I can, for China, for the fiscal year 25 in ESD, we plan high single-digit growth rate. For TSD, we plan mid-single-digit growth rates. That's our plan for China.

I also want to ask about China. By China issue and also anti-corruption campaign and policy, you have explained all of that, but on the other hand, Two times ago during the briefing, you explained that bank lending was stopped because of the lending issue. The lending was stopped because of some banking issue. I think this would have a long-term problem. This is a real estate related issue. And is this still affecting your business to a great extent or is it not really affecting your business that much anymore, the real estate lending? problem. Your products tend to be in bigger lots of bigger monetary amount. So do you think you would experience more problem from this real estate related bank lending issues? Just one question.

I'm not sure if I fully understand what you're referring to. So bank lending issues in China that could affect our business, honestly speaking, I'm not aware of. And I'm looking around my colleagues and everyone is shaking the head. So from our perspective, this has no negative impact on our business.

There was a problem with a bank lending in relation to the real estate, and it was affecting your business. I'm pretty sure I heard this in your earnings call before. So you talked about the Buy China and anti-corruption campaign or the policy perspective. So my question is, is your business being affected by banks not wanting to lend because of the real estate issue? Because that would have a long-lasting effect on your business.

I think Tomi Sakurai would contribute to this question.

Yes, this is Sakurai from IR. Mr. Akahane, your question, I believe, was not really explained from our side, from Olympus' side. If we had ever provided some kind of financial explanation, maybe something to do with... policy of a low interest rate to revitalize the capex investment, but we have not really ever told you anything about the lending issue. So there is not a serious impact of the real estate business. It is not to do with our business directly. Understood. Thank you. That's all from me.

about the gross profit, 6.8% expected for this fiscal year, which is higher than in recent years. What are the reasons for improvement? Is it just one time? No. 68.5, do you think that's still low? Do you think it could be better? So gross profit ratio. What are the basis for the assumptions for this fiscal year, 68.5% gross profit? So could I, from investor relations, let me answer that. In FY24, because of recall and others, this had impact on COGS. And the absence of such factors translates into improvement. So for the last three years, it was around 67% about the same. Whereas for this fiscal year, you are making the best case assumption. Would that be the case? No impairment loss? Again, this is Sakurai. The current assumptions on a constant currency basis are not much different from recent years. I see. Thank you.

I want to ask about the sales plan, revenue plan for this fiscal year, shortage of parts and QARA measures. And maybe there is still some restriction on the supply of the parts, I assume. So how much fluctuation do you expect in terms of sales impacted by that? Do you have like a range of impact that you're thinking about? And currently, what is the estimation of the impact?

Maybe question related to backorder is very much a topic for TSD. So maybe Seiji, you can give some insights about the backorder situation, one created by ship holds and the other by supply chain issues where we're working at the moment intensively to reduce the backorder and have already achieved some accomplishments.

Can you hear me? With regard to restricted supply backorder, there are two things mainly. One is part supply from vendor. This is a challenge. And the other is a remediation related issue. And TSD has been impacted quite a lot in terms of shipment last year. Vendor supply shortage impact is actually a big part of that. and compared to the peak we have already seen 30 improvement three zero and we can maintain this improvement trend for this fiscal year we expect additional 15 improvement in the next couple of months so vendor dependency related backorder will be resolved and based on that we expect growth i hope that answers your question

One for Izumi-san. Well, two for Izumi-san. First, share buyback. Well, policy remains unchanged if there is a surplus after the working capital and sufficient cash on hand. And the result is 100 billion yen. So what do you mean by sufficient cash on hand? to result in 100 billion yen share buyback. Yes, sufficient cash on hand that is at the beginning of the month. For this fiscal year, we have various investment plans, CapEx, and also the operating cash flow. In light of all this, secure sufficient amount at the beginning of the month that is the basis so it is based on that calculation that you came up with this 100 billion yen yes that is correct my second question uh many questions were asked as to how you put together the figures for this fiscal year Now adjusted operating profit, now close to 20%, we said, the margin. And of course, there's room for improvement going forward. So as the newly appointed CFO, Olympus has been targeting 20% for quite some time. Do you feel that you can do better? And if so, what will be the factors for improvement? Any thoughts on that? If you could also talk about the time frame, I'd appreciate it. Well, gross profit to be improved, I think, is one, and also controlling the SG&A. So that will be the focus for FY25, and whether we can do better than 20%. I'm afraid it's still premature for me to say when we can do that. So first of all, we have to achieve 20%. And that's what we need to focus on to make sure that we achieve 20%. So... An adjusted cost has been the factor for not being able to achieve 20% in the past. So maybe if you allow for 23%, then you can achieve 21%, maybe. So going forward, looking at your plans, what's realistic? of course there are things that cannot be incorporated but things that are likely to happen i think that kind of buffer needs to be put in our mind looking at your past achievements so what you're talking about is uh you know all the things added up and then allow some buffer. Is that what you're saying? Well, I'm not sure if that's the best way, but well, that is the practice, a common practice that we used in my previous employment. I don't know if that could be applicable to Olympus as well. I can't say at this point in time that that's applicable as well. Rather, I would like to get your insight as analysts as well. Thank you.

Let me add one point direction-wise. I mean, obviously, our company has the potential for margin improvement very clearly. But the first priority, especially in this year and the next year, is to return to growth and really put a strong focus on growth by bringing more products into the hands of our customers, by contributing to society and by improving the access and the outcome in healthcare. So that's the clear priority. So we really want to achieve solid above-the-market growth over the next couple of years. and steadily and continuously improve our margin. That's basically the general direction we are aiming at.