Olympus Corp

TSE:7733

Earnings Call Analysis

Steady Growth Amid Challenges

In the first quarter of fiscal year 2025, the company saw a consolidated revenue increase by 15% year-on-year, bolstered by strong sales in North America and a favorable yen depreciation. The EVIS X1 GI endoscopy system and other core areas like Urology and Respiratory showed robust growth. Despite challenges in China due to the anticorruption campaign, the company maintained its guidance for fiscal year 2025. Operating profit grew by 21%, and adjusted operating profit surged by 32%. Investments in strategic growth and quality transformation programs continue. The company's focus remains on consolidating its market position while expecting a cautious recovery in China.

A Strong Start to Fiscal Year 2025

The company has kicked off fiscal year 2025 on a positive note, demonstrating solid growth and strong performance across various segments. The CEO, Stefan Kaufmann, highlighted the impressive recovery and growth in both ESD and TSD. The company reported a 15% increase in consolidated revenue year-over-year, driven largely by the depreciation of the yen, which served as a tailwind.

Key Drivers of Growth

The EVIS X1 GI endoscopy system remains a significant growth driver, with strong momentum also observed in GI EndoTherapy, Urology, and Respiratory sectors, particularly in North America. The company's revenue in North America surged by 32% year-over-year, with substantial contributions from all strategic focus areas.

Challenges in China

Despite the overall positive performance, the market in China presents challenges. The region continues to be affected by the anticorruption campaign, volume-based procurement, and increasing local competition. These issues have led to a more difficult and persistent market environment than initially anticipated.

Financial Performance and Profitability

CFO Tatsuya Izumi provided detailed insights into the financials for the first quarter. Operating profit increased by 21%, reaching JPY 27.5 billion, mainly due to revenue growth and improved gross profit. Adjusted operating profit soared by 32% year-over-year to JPY 37.2 billion. The adjusted operating margin saw an improvement of 2.1 points, landing at 15.9%. These figures were supported by favorable foreign exchange rates.

Segment Performance

The ESD segment reported a 16% revenue increase year-on-year, with an adjusted operating profit of JPY 32.6 billion and a margin of 22.1%. Sales in North America for the GI Endoscopy subsegment grew by a staggering 62%, while sales in China declined due to the anticorruption campaign. The TSD segment also performed well, reporting a 13% increase in revenue and a 16% adjusted operating margin.

Cost Management and Investments

The company continues to exercise prudent cost controls while strategically investing in key areas, including QARA R&D and initiatives to boost productivity. This approach underscores the company’s commitment to maintaining a balanced and sustainable financial strategy.

Guidance and Outlook

Despite the challenges in China and recent forex fluctuations, the company has maintained its guidance for fiscal year 2025. The company anticipates continued robust recovery and stable operations, underpinned by its strong pipeline and proven business model. The management expressed confidence in achieving their growth targets for the year.

Cash Flow and Financial Position

Cash flow from operating activities was positive at JPY 23.3 billion, while cash flow from investing activities was negative JPY 15.2 billion, primarily due to investments in intangible assets and other expenditures. The company's cash and cash equivalents stood at JPY 276 billion at the end of June 2024. Free cash flow was reported at positive JPY 8.1 billion.

Earnings Call Transcript 2025-Q1

[Stefan Kaufmann, executive]

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 3 months of fiscal year '25, 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 '25.

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 by the tail end 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. Revenue 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 anticorruption campaign, volume-based procurement and increasing local competition seems to be more challenging and persistent than expected.

There is uncertainty in some areas, and we are actually aware of the recent chart 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 '25 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 '25.

We continue to maintain appropriate cost controls while continuing to invest strategically in strengthening our operational infrastructure including QARA 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.

[Izumi Tatsuya, executive]

[Interpreted] 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 12, 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 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 3 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 remain unchanged despite some adjustments due to the Orthopedic business being classified as a discontinued operation. Both revenue and adjusted operating profit are progressing smartly against the initial forecast.

Next, let's take a look at the business situation in each segment. First is the ESD. Revenue grew 16% year-on-year. Adjusted operating profit, excluding other income and 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 subsegment. 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 anticorruption 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 the 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 13.9 billion year-on-year, with an adjusted operating margin of 16%, an improvement similar to ESD.

Performance for each subsegment shows that all 3 focus areas, GI EndoTherapy, Urology and Respiratory grew, primarily in North America and Europe.

In GI EndoTherapy, sales increased in hepato-pancreato-biliary and 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 prosthetic hyperplasia, BPH treatment.

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 debt and the dividend payments. Additionally, both assets held for sale and liability directory related with assets for sale increased due to the transfer of Orthopedic 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 evident was included in the same period for the previous fiscal year, but adjusted free cash flow, excluding external 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 to mainly to an increase in profit before tax and deviation and amortization.

Cash flow from investing activities was a negative JPY 15.2 billion due mainly to expenditures associated with our acquisition of intangible fixed assets, intangible -- 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 external factors such as acquisition transfers and reorganizations.

Cash flow from finance activities was negative JPY 77.5 billion due to mainly to the repayment of long-term debt 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.

[Unknown Analyst]

[Interpreted] 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 -- is it the first quarter only or going to the second half? Because the previous year second half was very tough for this year, we're 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 more visibility in terms of how it'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.

[Izumi Tatsuya, executive]

[Interpreted] Thank you very much, [indiscernible], 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 compared to the last year first quarter didn't have anticorruption activity. So this year's April to June basically is in line with our expectations. But initially, we 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.

On the 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 gain is at the level of today, I think it's in line with our expectations. So we will strive so that 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 on this question from your side.

[Stefan Kaufmann, executive]

Yes. Happy to do so. And I think you asked a couple of questions, 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, we'll 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 be a little bit redundant to what Tatsuya said. Then the first quarter in China was in line with our expectation. So not very strong because we knew that the impact of the anticorruption campaign will have a strong influence on our ability to grow in the first quarter. But 3 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 macroeconomical environment at the moment, also seeing how other industries is not only met tech 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 challenging for us. So we're 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, and 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 '25.

Second, the strong yen or the strengthening of the yen. Obviously, the last couple of days has 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 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 the reality. Would further appreciate will it continue really will go back to the old level. I mean that's just speculation. There are no facts and no signs available 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 digits over the full year. So we do have very weak last quarter in fiscal year '24, which helps us to show the strong growth rate, and we also benefit that we are clearing at the moment, the back order situation caused by the Noto earthquakes.

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 opportunity. 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 bottom line of 19.6%. And that means if things from a top line perspective go in the wrong direction, we will take counter measures 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 confident that also our company has become more agile and flexible and cost adjustments, if necessary. That concludes my long answer to your short question.

[Unknown Analyst]

[Interpreted] My first question is about -- well, this is strong. And Mr. Kaufmann was 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 back order do you have built up? And also recession make it 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.

[Stefan Kaufmann, executive]

Actually, that's why I was hoping that you would take the question. But -- okay, then 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 doctor was hesitating to place orders for the old system. And we do see that the clearance of the back order 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 back order caused by the Noto earthquake. So that's 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 1100 scopes. Obviously, you also see that GI in urology, in respiratory. We see strong growth numbers. And I think especially 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, I 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 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 macroeconomical environment globally in the U.S. will develop. But from a pipeline perspective, order intake back order, we have a high level of confidence that we will accomplish our target in fiscal year '25 regardless of how the bigger economical picture in the U.S. will develop.

[Unknown Analyst]

[Interpreted] I have a follow-up question. So growth forecast in the United States for the full year, do you think is it higher than what you spoke about in May. Considering the endoscope X1 system and also scopes, I think, is a very important factor for your business. And the X1 scope has not been approved yet, I don't think so, when be approved. What is the time line? And if the scope is launched later, then the U.S. number should remain strong over the next 2 years? Is that the correct read on the situation?

[Stefan Kaufmann, executive]

Should I take that question?

[Izumi Tatsuya, executive]

Please.

[Stefan Kaufmann, executive]

Yes. 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 but beginning of the next fiscal, there's 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 '26, we will see steady growth rates in the high single-digit area for the U.S. but even beyond fiscal year '26. So I think that should fuel our growth pipeline for the next 3 to 4 years. Yes, that's 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.

[Unknown Analyst]

[Interpreted] So this is about the question related to costs. I would like Izumi--san to answer my question. First, Elevate-related costs. First quarter is about JPY 6 billion has been booked for the first quarter. I think for the full year, it was a JPY 19.4 billion will be included in the other cost. I think that has been your plan. So about 1/3 -- a little under 1/3 has been generated in the first quarter. Is it within your expectations? Or is it more than you expected? Or has it been front loaded? Can you give me some color on how this cost is showing up?

[Izumi Tatsuya, executive]

[Interpreted] Thank you very much for your question. As you have rightly understood, in the first quarter, and 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 late, it has -- I've been saying this is JPY 32 billion. So I think basically, the progress is in line against our initial expectations. So initially, the Elevate-related costs included in others in the first quarter and 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.

[Unknown Analyst]

[Interpreted] 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 expectations for the full year in terms of the career change support? How much is -- are you expecting for the full year? Can you give us some guidance?

[Izumi Tatsuya, executive]

[Interpreted] So currently, we are not expecting further costs coming up for a career change support. So 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 for me.

[Unknown Analyst]

I have a question for Mr. Kaufmann. The -- I think one of the things that is really impressive about Olympus in the last 1.5 years is that you've really been able to clean out some of the acquisitions that weren't exactly fruitful. So things like Veran Medical Technologies, what would have been called Spirus Medical, Taewong Medical. This isn't an acquisition made a collaboration with Terumo Olympus, Terumo Biomaterials and FH also. 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 3 focus areas that you are focused on. And I've always been of the opinion that the -- that device for it to be really competitive, it should be sold by somebody who has exposure to general surgery, not just not laparoscopy, but do open surgery. And so it doesn't be a strategic alliance with somebody who has exposure to that area make more sense in this area? And I have one follow-up concerning M&A. Should I ask the M&A question also?

[Stefan Kaufmann, executive]

Thanks for your question. So I have noted two questions. The one is you've seen a kind of way you express this cleanup of our recent M&A portfolio. Am I happy with as it is now and then you kind of transferred this question also to the entire lupus portfolio, right?

[Unknown Analyst]

Yes.

[Stefan Kaufmann, executive]

Okay. Let me answer the question. So indeed, for different reasons, we had to clean up our M&A portfolio that the 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, 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 the respiratory, we have to pursue further M&A activities to fuel our growth pipeline. And I believe mid-term M&A should account for 1% to 2%, our compound average growth rate as a company. So 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.

So 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.

The GI service, uro gene and respiratory. And 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.

And other players like Surgical, which includes Surgical Devices and surgical imaging and NTA 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 EMEA, where we have market share that satisfies our right to play in these areas. But what is a matter of fact is that we struggled significantly in the U.S.

I think in Energy Devices, our market share is around 2% or 3%. And that's obviously not enough. And 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. And there are different options. And I think some of them that you have already highlighted, the efforts by ourselves to strengthen the core area. We can look for partnerships, and 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 clean diligence and then take the appropriate decision.

So having said this, there is 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 our, to improve the competitiveness of our portfolio in order to divest.

[Unknown Analyst]

Just one follow-up on 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 fairly successful like VMT and Taewong. On the other hand, I think if you look at things like image street medical Sony Olympus, Medi-Tate [indiscernible] medical. I mean some of these things will probably contribute in the future, but some of them have a been successful. But my question is this, how are you changing the M&A, the due diligence, the bedding process because that's the concern from seeing things like Taewong. How have you changed the M&A sort of the business division? How you look at companies? If you could 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.

[Stefan Kaufmann, executive]

Well, excellent question. Thanks for having a fair look at our recent M&A activities because indeed not everything was a fair 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 2 most prominent ones failed for different reasons, of course Veran and Taewong. We have conducted an earnings session also with the support of an external party to really better understand where the areas for improvement are. We've come up with a business development transformation program, and there are a couple of changes we have already implemented or about to implement. So just to highlight two. One is we will establish the leadership of Izumi-san Governance Committee that will secure the for principal 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 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 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 see some changes in the reporting lines to the CEO. And from October onwards, I will be business development directly because I believe that as a 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.

[Unknown Analyst]

[Interpreted] So I would like to ask about your response and progress towards the warning letters currently. I want to ask whether the progress is going smoothly. And in the last quarter, you said that inspection from the FDA will be conducted at the end of this year. I think there was your guidance. What, no change in the progress. Can you enlighten me about that?

[Izumi Tatsuya, executive]

[Interpreted] So basically, things are going as planned, but Stefan will explain in detail.

[Stefan Kaufmann, executive]

Yes. 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 necessarily in order to call ourselves leading global medtech 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 be it 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 activity as an accomplishment ratio of 96%. So that's quite telling. So we really progress in line what we have committed towards FDA.

We have also improved significantly our entire 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%, 1 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 patients focus on patient centricity as the item at core value of Olympus. We have also accompanied this the resilience 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 that's 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 contain system that will be challenging for our company because, as you know, we still have the fragmentated IT system in our regions. So we have to connect the standardized system to many different subsystems. That's quite a challenge. But we have also as a pretty strong project team cross-functional and cross-regional to manage it successfully. So my level of confidence is so far, still very high.

And yes -- and with respect to the [ audits ] from FDA, 1 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 audit firm has now visited all sites that have been subject towards the warning letters. The reports look very encouraging. So they all to testify significant progress in our efforts.

And coming back to your last point, when will FDA come to reinspect, obviously, no. I cannot fix the schedule of FDA. The message we conveyed to FDA is that by mid of calendar year '25, we will be ready. So I expect FDA to visit these 3 sites starting from mid of calendar year '25, and that might take 1 year, 1.5 years until they have gone through all the 3 sites. But again, I don't have the schedule and no influence on the schedule from FDA.

And then my last point, obviously, the lifting of the warning letter is symbolically very important for us, but we proceed in good cooperation with FDA even as long as the warning letters are still existing. So we have received a couple of 510(k) approvals after submission, and we are in a very good and constructive dialogue, with the FDA, and this is regardless that the warning letters are still. But nevertheless, sometimes symbolic is also important, and we work very hard that we will be even in calendar year '15, calendar year in to lift the warning letters and comments FDA that we have not only learned our lesson, but that we have really increased capabilities and improved processes significantly.

[Unknown Analyst]

[Interpreted] This is a follow-up question. In terms of the quality-related costs. For next fiscal year onwards, your assumption is that change is going to go down substantially from next fiscal year onwards. I would like to confirm whether that is unchanged.

[Izumi Tatsuya, executive]

[Interpreted] So in terms of the cost for next fiscal year onwards currently, we can say for sure, but the internal we have now, there is nothing that is pressuring us to change the outlook, maybe, Stefan, you can follow up about this.

[Stefan Kaufmann, executive]

Certain. 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. And 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 may be in a situation that those costs to 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 part 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're making to Elevate our investments into the future of the company. So when you look at strengthening capabilities and regulatory, this can shorten the regulatory approval processes, which we 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 optimization.

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 thoughts at the moment is that from fiscal year '26 onwards, we delegate the costs into the respective cost center, and then we manage them as SG&A as we do manage also on the SG&A. That's our thought at the moment.

[Unknown Analyst]

[Interpreted] I'm listening to the Japanese translation. And with regard to the reaudit of FDA. So a little over calendar '25, we'll start from then, and it will be completed in the calendar 2026, fiscal in the calendar year are different in your case. Can we please -- can I please double check what you said about the FDA reaudit?

[Stefan Kaufmann, executive]

Right, happy to do so. And let me emphasize one more time on the fact that we cannot influence when FDA will inspect our site. 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 '25, we will be ready to be reinspected. So far, our relationship with FDA is so constructive that they talk with us about our self-perception when we will be ready to move and inspect it, which I think already shows how far we have come building trustful relationship and a good level of cooperation.

So then basically, they need to inspect 3 sites. All 3 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 3 sites. From that perspective, my estimate is that maybe by summer '25 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 or in order and ISO. So that's my estimate that the time corridor for FDA to inspect our sites will be between, let's say, August, September '25 until December 26. But it's guessing -- so basically, there is 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 only will -- only inspect Olympus sites but a couple more sites, around the world. Does that clarify?

[Unknown Analyst]

[Interpreted] Thank you very much. So I just wanted to check whether it was calendar year or fiscal year. So that's all clear. Yes.

[Unknown Analyst]

[Interpreted] 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 -- how you solve the backward risk related to the Noto earthquake?

[Izumi Tatsuya, executive]

[Interpreted] So in the first quarter, actually, some is included. However nothing, not all is solid in the first quarter. So I think the backorder situation resolved in August. So the first quarter and the second quarter, this is how the backorder situation is going to be resolved. That's the right now.

[Unknown Analyst]

[Interpreted] 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 expected? Or has the market become better than expected? I would like to get some color on what you have mentioned.

[Izumi Tatsuya, executive]

[Interpreted] So Stefan? Should ask up [indiscernible]...

[Stefan Kaufmann, executive]

Yes, why not. I think that's a good idea, area.

[Izumi Tatsuya, executive]

So could you please answer this question?

[Gabriela Kaynor, executive]

Thank you very much. Gabriela Kaynor, 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 our -- 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 back order perspective and from a quality remediation and ship hold perspective in neurology. And this has had obviously a positive impact in our growth and recovery for the Urology business.

We have certain aspects of our business in certain product categories where we see definite growth in the market and steady growth as we have seen 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, our sales teams and commercial teams have been able to maintain our customer loyalty. And so specifically in the areas of reflection 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.

[Unknown Analyst]

[Interpreted] I have a question about ESD about profitability. Q1 adjusted OP margin, 22% and 21% before the FX adjustment. Full year is 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 quarter, although only in the second half of the fiscal year to fill the gap?

[Izumi Tatsuya, executive]

[Interpreted] Thank you for your question. It's not a seasonal 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 question answer.

[Stefan Kaufmann, executive]

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 also has a negative impact on our margin because in China, we have a very nice margin.

[Unknown Analyst]

[Interpreted] Understand. Now I have actually a follow-up, sorry, please continue.

[Stefan Kaufmann, executive]

We believe if we can recover in the second half of the fiscal year '25 in China and show growing sales that this will also have a positive implication on the margin for our GI business. Sorry. for interrupting.

[Unknown Analyst]

[Interpreted] Yes. 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.

[Izumi Tatsuya, executive]

[Interpreted] 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 anticorruption campaign had already started last year. So if you compare this second quarter versus last year 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.

[Unknown Analyst]

[Interpreted] But it's not a negative growth.

[Izumi Tatsuya, executive]

[Interpreted] 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.

[Portions of this transcript that are marked [Interpreted] were spoken by an interpreter present on the live call.]