Hello, everyone. I'm Stefan Kaufmann, CEO, and welcome to today's earnings call. I'm pleased to see you all today. I'm glad to be able to start the earnings call of the first quarter on a positive note. In the first three months of fiscal year 2025, we have recovered as planned and have achieved solid growth in both ESD and TSD. We have controlled SG&A well, and therefore, our consolidated results are well on track and in line with our expectations. The EVIS X1 GI endoscopy system remains a strong growth driver, but we also see good momentum in GI endotherapy, urology, and respiratory, especially in North America. I'm confident that we will keep the good momentum throughout fiscal year 2025. The ongoing remediation and quality transformation program, Elevate, is continuing to progress well, and we continue to meet our commitments to the FDA.
Revenue increased by 15% on a consolidated basis year-on-year, accelerated by the tailwind of the depreciation of the yen. In medical service, we saw steady growth in all regions. I'm particularly happy about our performance in North America, where we achieved 32% growth year-on-year with strong sales in all our strategic focus therapeutic areas: GI, urology, and respiratory. We have also continued to see strong growth in emerging markets, especially in ESD, achieving over 20% growth year-on-year. On the other hand, the market situation in China, which continues to be affected by the anti-corruption campaign, volume-based procurement, and increasing global competition, seems to be more challenging and persistent than expected. There's uncertainty in some areas, and we are actually aware of the recent yen exchange rate fluctuations.
Although we continue to carefully monitor the situation, looking at the results achieved in the first quarter, we have not changed our guidance for fiscal year 2025 from our previous announcement. With a solid pipeline of growth drivers in our defined clinical focus areas and our proven business model, we anticipate a continued sound recovery and stable operations overall in fiscal year 2025. We continue to maintain appropriate cost controls while continuing to invest strategically in strengthening our operational infrastructure, including QA/RA, R&D, and initiatives to further improve productivity. After this short, high-level introduction, let me hand it over to our CFO, Tatsuya, who will lead you through our detailed financials for the first quarter. Thank you.
Hello, everyone. I am Tatsuya Izumi, CFO. I would like to provide a consolidated financial results and business review for the first quarter of fiscal year 2025. As we disclosed on July 12th, we completed the transfer of the orthopedic business in July. As a result, we have classified the orthopedic business as a discontinued operation, so today, my explanations will focus on continuing operations. Consolidated revenue increased by 15% year-over-year, with the yen depreciation serving as a tailwind, as Stefan explained. The medical business reached a record high for the first quarter, led by strong sales in North America, where EVIS X1 GI endoscopy system, et cetera, performed well. All three focus areas, GI, urology, and respiratory, grew double digits.
Operating profit increased by 21% year-over-year to JPY 27.5 billion, due mainly to revenue growth and improvement of gross profit, despite increased expenses in R&D for the next generation endoscopy system, et cetera, and higher costs associated with the holistic remediation and transformation program, Elevate. Adjusted operating profit increased by 32% year-over-year to JPY 37.2 billion, with an adjusted operating margin improving 2.1 points to 15.9%. As you can see, these financial results were largely supported by Forex. However, even after adjusting for Forex, revenue increased by 3% and adjusted operating profit increased by 14%. Our initial full-year forecast remained unchanged, despite some adjustments due to the orthopedic business being classified as a discontinued operation. Both revenue and adjusted operating profit are progressing smoothly against the initial forecast.
Next, let us look at the business situation in each segment. First is the ESD. Revenue grew 16% year-on-year. Adjusted operating profit, excluding other income expenses, significantly increased to JPY 32.6 billion year-on-year, with an adjusted operating margin of 22.1%, an improvement from the same period from the last fiscal year. I would like to now give a review of the first quarter performances for each sub-segment. In GI endoscopy, sales in North America grew 62%, led by strong sales of EVIS X1 GI endoscopy system. On the other hand, sales declined in China due to the impact of the anti-corruption campaign, among others. In surgical endoscopy, sales declined in North America, while increasing in Europe. Sales of the surgical endoscopy system, VISERA ELITE III, remains solid.
In medical service, we saw steady growth in all regions, especially in North America and Europe, due to stable revenue streams based on service contracts, including maintenance services and an increase in new accounts. Next, in the TSD, revenue grew 13% year-on-year. Adjusted operating profit, excluding other income and expenses, increased to JPY 30.9 billion year-on-year, with an adjusted operating margin of 16%, an improvement similar to ESD. Performance for each sub-segment shows that all three focus areas, GI endotherapy, urology, and respiratory, grew, primarily in North America and Europe. In GI endotherapy, sales increased in hepatopancreatobiliary and the hemostasis-related products. In urology, the sales increase was led by SOLTIVE SuperPulsed Laser System for urinary tract stone management and resection electrodes for benign prostatic hyperplasia, BPH, treatments.
In respiratory, we saw strong performance in the EBUS scopes and the therapeutic devices mainly used in EBUS-TBNA. This is the financial position and balance sheet at the end of June 2024. Total assets decreased by JPY 18.8 billion compared to the end of the previous fiscal year. Major factor for this is decrease in cash and cash equivalents due to the repayment of long-term debts and the dividend payments. Additionally, both assets held for sale and liability directly related with assets for sale increased due to the transfer of our fertility business. The equity ratio rose 52.1%, up 2.7 points from the end of the previous fiscal year. Status of cash flows.
Cash flow may appear to have decreased significantly because the impact of the transfer of Evident was included in the same period for the previous fiscal year, but adjusted free cash flow, excluding extraordinary factors, improved year-on-year. Looking at each item, cash flow from operating activities was positive JPY 23.3 billion. It increased year-on-year due mainly to an increase in profit before tax and depreciation and amortization. Cash flow from investing activities was negative JPY 15.2 billion, due mainly to expenditures associated with acquisition of intangible fixed assets, tangible fixed assets, intangible assets, and investment securities. Free cash flow was positive JPY 8.1 billion. Adjusted free cash flow was positive JPY 14.8 billion, excluding extraordinary factors such as acquisitions, transfers, and reorganizations.
Cash flow from finance activities was -JPY 77.5 billion, due to mainly to the repayment of long-term debts and the dividend payments. Resulting cash and cash equivalents stood at JPY 276 billion at the end of June 2024. That concludes my explanation. Thank you for your attention.
So let's go to the Q&A session.
My first question is about the confirmation about the external environment, and how are you going to responding to the situation? So China seems to be tougher than you have anticipated. In the first, it was... Is it the first quarter only, or for going to the second half? Because the previous year, the second half was very tough. For this year, you were anticipating some level of recovery in the second half, but this has become tough as well. It's difficult to say what's going to happen going forward, but you have talked about the risk of the stronger yen. So I think there is a poor visibility in terms of what's going to happen to the external environment.
But if China is going to become tougher than you have anticipated, will you control the cost so that you'll be able to achieve the guidance? Is that your intention for your full year guidance? Let me confirm about that point.
Thank you very much. So let's answer your question. From my side, I would like to briefly give you an explanation, and then I will hand it over to Stefan to follow up my answer. Well, in terms of China, the first quarter, going to the first quarter, year, compared to the, last year, first quarter didn't have the anti-corruption activity. So this year's April to June, basically, is in line with our anticip- expectations. But initially, we were anticipating that this will end in June, and from July, we were expecting some V-shaped recovery, but we think that this recovery is going to be delayed. From second half onwards, we do expect some recovery, but I think we have to be, resilient in terms of our outlook.
In terms of the risk of the stronger yen, so if the yen is at the level of today, I think it's in line with our expectations. So we will strive so that, not saying that because of the stronger yen, we won't be able to reach the guidance. But, I think basically this fluctuation in the currency is quite recent. So at this point, we don't have any specific actions right now.
... Stefan, can you answer a follow-up, this question from your side?
Yes, happy to do so. And I think you asked a couple of question, and one is related to our estimate about China. The other one is how do we respond to the sharp fluctuation with respect to the exchange rate? And the third one is, if things go worse than expected, will we be able to control our costs to deliver at the end of the day, the bottom line we promised in our guidance for the full year? So let me start with China. It will be a little bit redundant to what Tatsuya said. The first quarter in China was in line with our expectation, so not very strong, because we knew that the impact of the anti-corruption campaign will have a strong influence on our ability to grow in the first quarter.
Three months ago, we were a little bit more bullish on how much we can recover in the second half of the year, because we wanted to achieve high single-digit growth rate in China. Seeing the macroeconomic environment at the moment, also seeing how other industries, it's not only MedTech at the moment, see that there might be some structural issues in China, that this is not just a seasonal phenomenon. We are just a little bit more careful, and we believe that to achieve high single-digit growth rate in China for the full year will be quite, quite challenging for us. So we are a little bit more prudent and careful in the way we express our expectation, but that does not mean that we have changed the targets.
We have set up a task force in order to mitigate the headwinds we see at the moment in China and find ways to achieve our growth rate in fiscal year 2025. Second, the strong yen or the strengthening of the yen. Obviously, the last couple of days have been pretty much a surprise for everyone. It was like a rollercoaster, not only the yen, but also the stock markets globally, but in particular in Japan. One reason why we also do not revise our guidance is for the full year with respect to the exchange rate, that no one really knows how that currency will develop over the next couple of months. I think that's a reality. Will it further appreciate? Will it continue? Will it go back to the old level?
I mean, that's just speculation. There are no facts and no signs available, and from that perspective, we decided to keep the exchange rate as announced in the guidance. And we do believe that in some regions we have growth potential that goes beyond what we have seen in the first quarter. U.S. is very strong, but also to be realistic, we will not continue to grow in the U.S. high double digit over the full year. So we do have the very weak last quarter in fiscal year 2024, which helps us to show this strong growth rate, and we also benefit that we are clearing at the moment the backorder situation caused by the Noto earthquake. But in APAC, we see more growth potential.
At the moment, the strike of the doctors in Korea, and Korea accounts for 45% of our sales in the APAC region, hampers our growth opportunities, so we don't believe that this will last for the full year. And as you know, we have launched X1 a few months ago in Korea, so we do see a significant growth potential over the midterm. And we are also positive that in Europe, we can see stronger growth rates after the election has happened in the U.K., and we hope that funding of NHS will improve and that they will release some of the budgets over the remaining year of the fiscal. So all in all, we see a big headwind in China. We see some opportunities in other regions.
We don't know how the yen will develop over the next couple of months, but we are committed to deliver our bottom line of 19.6%, and that means if things from a top-line perspective go in the wrong direction, we will take countermeasures in order to control our costs further. And you might have seen it in the presentation, we have already made significant progress in monitoring and controlling our budget. So I'm quite confident that also our company has become more agile and flexible in cost adjustments, if necessary. That concludes my long answer to your short question.
Thank you very much.
Thank you for this opportunity. My first question is about... Well, the U.S. is strong, and Mr. Kaufmann was smiling as he was talking about the United States, so it shows how strong it is. Can you please give us more details about the situation in the United States? So the first quarter is finished. How much backorder do you have built up? And also, recession may be coming in the United States. Do you think the demand is strong enough to counter the recession, potential recession? And for the second half of the year, how strong do you think the demand will be? That's my question, first question. So should I direct this question to Stefan? I think I should.
Actually, actually, Tatsuya, I was hoping that you would take the question, but okay, then let me, let me start, and most likely, you have to help me a little bit with some concrete numbers. So as I said, when you look at the first quarter results in the U.S., they are a little bit inflated through a couple of impacts that show a significant growth rate to the last quarter to the first quarter in the last fiscal, I named them already. One is that, last quarter, first quarter last year, we announced in the U.S. the launch of X1 that led to a situation that doctors were hesitating to place orders for the old system.
And we do see that the clearance of the backorder situation, approximately for the global company, when you see that ESD was growing 4.8%, you can dedicate 1.1%-1.2% to the clearance of the backorder caused by the Noto earthquake. So that's just to kind of calibrate a little bit the numbers. When you look at order intake, we are still extremely bullish about the U.S. So our target to show high single-digit growth, I believe is very realistic. And the growth is not only driven by X1 and the 1,100 scopes. Obviously, you also see that in GI endotherapy, in urology, in respiratory, we see strong growth numbers.
I think especially in urology, I'm very happy that we could quickly regain momentum, because last year, urology was quite significantly affected by ship holds on quite a lot of products. But it seems that our customers stayed loyal with us, and that our sales team really managed to get back into the hospitals and promote and then advertise and sell our products. So all in all, don't expect high double-digit growth rates for the U.S. for the full year, but single-digit growth rate is definitely our target. And if the recession basically will have an impact on our order intake, this is hard to predict at the moment, because at the moment, we are not yet in a recession. And very difficult to speculate how the macroeconomic environment globally in the U.S. will develop.
From a pipeline perspective, order intake backorder, we have a high level of confidence that we will accomplish our target in fiscal year 2025, regardless of how the bigger economic picture in the U.S. will develop.
Thank you very much. I have a follow-up question. So growth forecast in the United States for the full year, do you think it is higher than what you spoke about in May? Considering the endoscope, the EVIS X1 system and also scopes, I think is a very important factor for your business. And if the X1 scope has not been approved yet, I don't think so. When will it be approved? What is the timeline? And if the scope is launched later, then the U.S. number should remain strong over the next two years. Is that a correct read on the situation?
Shall I take that question?
Please.
Yeah. I mean, that's obviously a very true interpretation of the facts. So we have launched X1, we have launched the 1100 scopes. We have not yet launched 1500 scopes, and this will happen by the end of this fiscal, by the beginning of the next fiscal. Depends a little bit on the regulatory approval process, and how fast we will receive the 510(k). But that's our estimate that not only for fiscal year 2026, we will see steady growth rates in the high single digit area for the U.S., but even beyond fiscal year 2026. So I think that should shoot our growth pipeline for the next 3-4 years.
Yeah, that's, that's our, our understanding of how the launch plan over the next couple of years will have a positive impact on growth ratios in the U.S.
Understood. Thank you.
This is about the question related to cost. I would like Izumi-san to answer my question. First, Elevate-related cost. The first quarter is about JPY 6 billion, has been booked for the first quarter. I think for the full year, it was JPY 19.4 billion will be included in the other cost. I think that has been your plan. About one-third, a little under one-third, has been generated in the first quarter. Is it within your expectations, or is it more than you expected, or is it been front-loaded? Can you give me some color on how this cost is showing up?
Thank you very much for your question. As you have rightly understood, in the first quarter, in the others is JPY 6 billion, in SG&A, about JPY 2 billion, and total JPY 8 billion has been included for the first quarter. In terms of the cost related to Elevate, it has. I've been seeing there's a JPY 32 billion, so I think basically the progress is in line against those expectations. So initially, the Elevate-related costs included in others in the first quarter, in the first half, it will be more concentrated in the first half of the first quarter.
That has been planned?
Yes. Basically, yes, that's the correct understanding.
So the full year plan is unchanged?
Yes, that's true. We haven't changed that.
Thank you. As a follow-up, I have another question. So in terms of the JPY 22.6 billion for the career change support spending, is it in line with the expectations for the full year in terms of the career change support? How much is it are you expecting for the full year? Can you give us some guidance?
So currently, we are not expecting further costs coming up for a career change support. So it's JPY 2.9 billion in the first quarter, and that's it. And afterwards, we're going to see more of an effect contribution. So the hundreds of millions of yen level, that may come up, but not as large as we are seeing right now. So that's all from me. Thank you.
Yes, I have a question for Mr. Kaufmann. You know, I think one of the things that is really impressive about Olympus in the last year and a half is that you've really been able to clean out some of the, the acquisitions that weren't exactly fruitful. So things like Veran Medical Technologies, what would've been called Spirus Medical, Taewoong Medical. This isn't an acquisition, but it's a, you know, collaboration with the JV of Olympus, Terumo Biomaterials, and FH Ortho. So my question is this: Are you happy with the portfolio as it is right now, or is there still something that could still move? Obviously, what I would have in mind is things like THUNDERBEAT, the energy devices, that doesn't quite fall into the three focus areas that you are focused on.
I've always been, you know, of the mind, of the opinion that that device, for it to be really, you know, competitive, it should be sold by somebody who has exposure to general surgery, not just laparoscope, laparoscopy, but, you know, the open surgery. So doesn't the strategic alliance with somebody who has exposure to that area make more sense in this area? I have one follow-up concerning M&A. Should I ask the M&A question also?
Thanks for your question. So I've noted two questions. The first one is, you have seen a kind of, the way you expressed it, is a cleanup of our recent M&A portfolio. Am I happy with as it is now? And then you kind of, kind of transferred this question also to the entire Olympus portfolio, right?
Exactly.
Yeah. Okay. Then let me answer the question. So, in indeed, for different reason, we had to clean up our M&A portfolio that those companies that we acquired since 2019. And I believe that we have now done the cleanup work to the greatest extent. So I would not... I don't plan to give you further surprises in this fiscal year for further cleanup activities with respect to our M&A portfolio. Having said this, obviously, and my stance has not changed, M&A is one of the value pools for growth, and especially in the areas that we have defined as our core therapeutic areas, like gastrointestinal, including GI, ET, and service in urology and in respiratory.
We have to pursue further M&A activities to fuel our growth pipeline. I believe midterm M&A should count for 1%-2% of our compound average growth rate as a company. We have to further strengthen our M&A muscle, and we have to learn from our recent acquisitions, and we have to improve maturity and capabilities inside the organization. When you look at the total portfolio, we do have already made a pretty distinctive decision what areas we prioritize. These are the ones I mentioned before: GI, GIT service, urology, and respiratory.
These are the areas where the majority of the resource allocation is dedicated to in order to make investments for further growth, maybe if possible, above the market growth. Other areas like surgical, which includes surgical devices and surgical imaging, and ENT, are regarded as optimized business units where we look more at opportunities to improve the profitability. Now, talking specifically about THUNDERBEAT, I think THUNDERBEAT is an amazing product. I think it is very competitive compared to what is available in the market. And we do have a right to play in, for example, in regions like Japan and in EMEA, where we have a market share that satisfies our right to play in these areas.
But what, as a matter of fact, is that we struggle significantly in the U.S. I think in energy devices, our market share is around 2 or 3%, and that's obviously not enough. As a company, we have to continuously look at our portfolio and take decisions how we can optimize the portfolio from a value creation point of view. There are different options, and I think some of them you have already highlighted, either we take efforts by ourselves to strengthen the core area, we can look for partnerships, we can also look for opportunities of divestment. So basically, the full range of option is available, and I think as a company, on a regular basis, we should do...
Due diligence, and then take the appropriate decision. So having said this, there's nothing at the moment to share with you and the other analysts and investors, so there are no further plans from our side at this moment of time, to look for strategic partnerships in order to improve the competitiveness of our portfolio, nor to divest.
Stefan, thank you. Just one follow-up on the M&A, because one of the concerns about Olympus is obviously the track record for M&A has been a bit spotty. There's been obviously things that were not terribly successful, like Veran and Taewoong. On the other hand, I think, you know, if you look at things like Image Stream Medical, Sony Olympus, Medi-Tate, Arc Medical, I mean, some of these things will probably contribute in the future. But some of them have been successful. But my question is this: How are you changing the M&A, the due diligence, the vetting process? Because that's the concern from seeing things like Taewoong. How have you changed the M&A, sort of the business division, how you look at companies?
If you could, you know, share with us any changes you've made in terms of the M&A sort of decision-making progress, the process, that would be great.
Yeah. Thanks for the question, Tyson, and also thanks for having a fair look at our recent M&A activities, because indeed, not everything was a failure. So we have done also a couple of acquisitions that will continuously contribute to the value creation of the company, and also to serve our customers better and offer them more holistic and more complete solutions. Unfortunately, the two most prominent ones failed for different reasons. It was Veran and Taewoong. We have conducted a learning session also with the support of an external party, to really better understand where the areas for improvement are. We have come up with a business development transformation program, and there are a couple of changes we have already implemented or are about to implement.
So just to highlight two, one is we will establish under the leadership of Izumi-san, a governance committee that will secure the four I's principle on all M&A and business alliances, activities, to make sure that the business case is solid. We have done a capability analysis, not only within BD, but for the entire company, to support due diligence, to support PMI, and we are in the process to recruit people that have more experience in HR, in finance, in legal, and in other areas to give better support to M&A. And then last but not least, you might have seen today that we have also made some changes in the executive officer structure, and we also have made some changes in the reporting lines to the CEO.
And from October onwards, I will lead business development directly, because I believe that as the CEO of the company, I can make in some areas a greater and a faster impact on maturing not only the function, but the whole organization, so that we are more fit for M&A activities.
Thank you very much.
So I would like to ask about your response and progress towards the Warning Letters. Currently, I will want to ask whether the progress is going smoothly. In the last quarter, you said that inspection from the FDA will be conducted at the end of this year. I think that was your guidance. What? No change in the progress? Can you enlighten me about that? Thank you very much.
Basically, things are going as planned, but Stefan will explain in detail.
Yeah. No, happy to do so. So I'm super proud and happy about the progress we have made, not only in remediating the findings that resulted into the warning letters, but really bringing the whole company on a higher level, and also on changing the culture and building new capabilities that are necessary in order to call ourselves leading global med tech companies. I mean, I think numbers are always the best to share. So we have made hundreds of commitments to FDA. Each commitment is like a project. We follow up on the accomplishment of the project and of the milestone of the projects, and we have achieved so far. We have kept this pretty steady since we started the remediation activities, an accomplishment ratio of 96%. So that's quite telling.
So we really progress in line with what we have committed towards FDA. We have also improved significantly our on-time reporting of complaints to FDA. You know that the goal is 99.7% within 30 days. We have not yet—we did not yet go live with our new complaint handling system, but nevertheless, every month, the accuracy of our reporting and the timeliness of our reporting is in the area of 99.5%, 99.6%. One month it was even 99.8%. So that shows that we have built capability in that area.
And last but not least, and I was kind of referring to this at the beginning, we have put a very strong focus on culture change, so we have not only changed our core values and added patient focus and patient centricity as the ultimate core value of Olympus, we have also accompanied this with gazillions of activities and workshops with a very active participation of all executive officers to really make our company not only compliant to regulations, but really put the safety of the patient on top of mind, and as the basis and foundation of all our activities and decision making. So progress is very well. Continuing, we will have end of this year, one important milestone when we go live with our new complaint handling system.
That will be challenging for our company, because as you know, we still have the fragmented IT system in our region. So we have to connect a standardized system to many different subsystems. That's, that's quite a challenge. But we have also established a pretty strong project team, cross-functional and cross-regional, to manage this successfully. So my level of confidence is so far still very high. And, yeah. And with respect to the, with to the audits, from FDA, maybe one additional information. So one of the commitments when I traveled last year to FDA, was that we would engage an external firm that runs independent audits to monitor the progress we make on our remediation. This, this, audit firm has now visited all sites that have been subject, to the warning letters.
The reports look very encouraging, and so they also testify significant progress in our efforts. Coming back to your last point, when will FDA come to reinspect? Obviously, I don't know. I cannot fix the schedule of FDA. The message we convey to FDA is that by mid of calendar year 2025, we will be ready. So I expect FDA to visit these three sites, starting from mid of calendar year 2025, and that might take one year, one and a half years until they have gone through all the three sites. But again, I don't have the schedule. I don't have an influence on the schedule from FDA.
My last point, obviously, the lifting of the warning letters is symbolically very important for us, but we proceed in good cooperation with FDA, even as long as the warning letters are still existing. We've received a couple of 510(k) approvals after submission, and we are in very good and constructive dialogue with the FDA. This is regardless that the warning letters are still around. But nevertheless, it's sometimes symbolic is also important, and we work very hard that we will be able, in calendar year 2025, calendar year 2026, to lift the warning letters and convince FDA that we have not only learned our lesson, but that we have really increased capabilities and improved processes significantly.
Thank you very much. This is a follow-up question. In terms of the quality-related cost, for next fiscal year onwards, your assumptions are not changed, it's going to go down substantially from next fiscal year onwards. I would like to confirm with you that is unchanged. So in terms of the cost for next fiscal year onwards, currently, we can't say for sure, but in terms of we have no there's nothing that is pressuring us to change the outlook. Maybe Stefan, you can follow up about this.
Sure. I think the discussion about Elevate has been ongoing between us since we established the program and announced that the cost would be in the area of JPY 60 billion. I think since then, we've been struggling really to clearly explain what is above the line, what is below the line, what are costs that will stay, what are costs that will go away. I think from next year onwards, we will be in a situation that those costs who go away because they are directly related to the remediation, will become very small. Because we are done by end of this fiscal year with the majority of our remediation activities, and then we will talk more about costs that will affect the SG&A and COGS obviously as well.
So our thought at the moment is, if we not from the perspective of budget management, consider next year to dissolve Elevate, continue with the program, and then put the cost into the accountability of the respective functions, and then they have to be managed in line with the SG&A expectation. So that's one thought we're having at the moment. That does not mean that the cost of Elevate, as announced, will continue to increase. But at the end of the day, and I've explained this a couple of times, many of the investments we make into Elevate are investments into the future of the company. So when you look at strengthening capabilities in regulatory, this can shorten the regulatory approval processes, which will help us to move the value chain of Olympus much faster.
It's into digitalization of our processes in manufacturing, which does help us to become more productive and effective in the way we run our production technologies, and have a higher level of automation. So at the end of the day, this year we will continue with Elevate as a bucket for costs that are related to remediation and transformation. Our thought at the moment is that from fiscal year 2026 onwards, we delegate the costs into the respective cost center, and then we manage them as SG&As, we do manage also other SG&As. That's our thought at the moment.
Thank you very much, that's all from me.
I'm listening to the Japanese translation, and with regard to the re-audit of FDA. So middle of calendar 2025 will start from then, and it will be completed in the calendar year 2026. Fiscally and the calendar year are different in your case. Can we please, can I please double-check what you said about the FDA re-audit?
Right, I'm happy to do so. Let me emphasize one more time on the fact that we cannot influence when FDA will inspect our sites. So you have to take my statement as perception and anticipating and everything I know at the moment and how we communicate with FDA, but there's no guarantee about this. So our signal to FDA is that by mid of calendar year 2025, we will be ready to be re-inspected. So far, our relationship with FDA is so constructive that they talk with us about our self-perception when we will be ready to be re-inspected, which I think already shows how far we have come in building trust for a relationship and a good level of cooperation. So then, basically, they need to inspect three sites. All three sites are in Japan.
So that might take some time for them to organize this. I don't think they can do this within 12 months, all three sites. From that perspective, my estimate is that maybe by summer 2025 or early fall, they will inspect the first site, and then it might take 12 months to finish all sites that received the warning letters, namely, Hachioji, Hinode and Aizu. So that's my estimate, that the time corridor for FDA to inspect our sites will be between, let's say, August-September 2025 until December 2026. But it's guessing. So basically, there's no confirmation from FDA, and we can discuss with them.
But obviously we have no influence how they, at the end of the day, set up their calendars and schedule, because obviously they're not only inspect Olympus sites, but a couple more sites around the world. Does that clarify?
Thank you very much. So I just wanted to check whether it was calendar or fiscal year, so that's all clear. Thank you. Thank you very much.
Yep.
For the first quarter sales, the Noto earthquake impact, resolution of the back orders, is it not reflected at all? This is going to be reflected in the second quarter at once. Is that how you're going to book the, the, how you solve the back orders related to the Noto earthquake?
So in the first quarter, actually, some is included. However, nothing again. And not all is solved in the first quarter. So I think all the backorder situation we resolved in August. So the first quarter and second quarter, this is how the backorder situation is going to be resolved. That's the situation right now. Thank you very much.
So this is another follow-up. This is about the other business. I would like to ask about the TSD.
You talked about urology products, so the momentum in the first quarter has been accelerating. You talked about that. So maybe, this is due to the resolution of the supply chain. The resolution has been going forward better than you expected, or, has the market become better than expected? I would like to get some color on what you have mentioned. So, Stefan, Sean?
Well, should I ask Gabriella to take?
Yeah, why not? I think that's a good idea.
So, Gabriella,
Hi.
Could you please answer this question?
Thank you very much. Gabriella Kainer, Chief Strategy Officer. So from a urology-specific perspective, I think this is a business where throughout the course of last fiscal year, we had definite headwinds from a both supply chain perspective, as well as some of the quality issues with related to some ship holds. And so we have seen recovery on both of those fronts from a backorder perspective and from a quality remediation and ship hold perspective in urology. And this has had, obviously, a positive impact in our growth and recovery for the urology business. We have certain aspects of our business and certain product categories where we see definite growth in the past few years.
And this is procedure volumes, which is Stefan alluded to earlier, is a really good sign and encouraging to see that despite some of the setbacks that we had in stable supply last year, our sales teams and commercial teams have been able to maintain our customer loyalty. And so specifically in the areas of resection and as well as in the areas of lithotripsy, we have seen a nice rebound in growth in the first quarter of this year. And particularly when we see in the areas of the U.S. and Europe, we're seeing that recovery. Thank you. That concludes my answer.
Thank you very much. That's all from me.
I have a question about ESD, about profitability. Q1 adjusted the OP margin 22%, and the 21% before the FX adjustment. Full year is at 27%, so there is still a gap. So my question is, Q1 margin, is this within your expectation? And, is margin going to be increased in the second quarter or the only in the second half of the fiscal year to fill the gap?
Thank you for your question. It's not a sizzle factor, but, compared to Q1, Q2, Q3 tend to have higher revenue as well as high profitability in this, business, usually. And, Stefan?
Could you give us the detailed answer?
I'm not sure if I fully understood the question. I think the question was related to margin development in GI and if we are satisfied. I think one factor we see at the moment is the so-called mix effect. As you know, our sales in China are weaker than in the years before, and also the proportion of the China business on the global ESD sales, especially in GI, has become lower in this first quarter. And that always has a negative impact on our margin, because in China, we have a very very nice margin.
Thank you.
Got much to you.
Understand. Thank you. Now, I have actually a follow-up. Oh, sorry, did I interrupt you? Please continue.
We believe if we can recover in the second half of the fiscal year 2025 in China and show growing sales, that this will also have a positive implication on the margin for our GI business. Sorry for interrupting.
Thank you.
Yes, thank you. So second quarter, July to September, sales in China on a quarter-by-quarter basis, compared to the first quarter, maybe second quarter will grow 10%. How much growth do you think we can expect in the second quarter compared to the first quarter? That kind of guidance would be very helpful for us.
This is actually very difficult and, difficult to estimate. Compared to Q1, we do not expect Q2 to grow dramatically. And compared to the previous fiscal year, well, the anti-corruption campaign had already started last year. So if you compare this second quarter versus last year's second quarter, the dip is not as big as, the first quarter. But if you compare the first quarter and second quarter, I don't think the second quarter will show a big improvement.
But it's not a negative growth, yes, correct?
It's not a negative growth, no. Second quarter should be better than first quarter, but, we are not expecting dramatic improvement for the time being, not necessarily.
That's very clear. Thank you.