Now we would like to move on to Q&A. My first question is about GI endoscopy doing very well in the United States.

EDOF scope penetration for high-end customers. What is the penetration rate, adoption rate?

In other words, it's pretty strong in the first half, but do you think the trend will continue in the second half of the year? That's my first question.

Thank you for the question. I'll have Keith jump in here in a minute, but you're right to point out that our EDOF scope and our EVIS X1 adoption has been strong.

We believe there's upside, continued upside to that penetration, not just in North America. Keith, as the question was about North America, do you want to talk about North America specifically?

Look. EVIS X1 represents the leading edge of our innovation strategy.

I would say in the US, we're still kind of early to mid innings in terms of our penetration rates. EMEA and Japan are a little bit further along, but there's still multiple years of runway ahead in the United States, particularly as we extend the EDOF scope family and start to layer in software and service attachment on top of the hardware platform.

Our strategy is to keep adding new scope variants and omni-sense capabilities specifically, we're not relying on the base platform alone to sustain the multi-year growth cycle. Thank you.

My second question. R&D expenditure and also contributing to the profitability.

R&D expense is actually down by 2.5 billion in the first quarter. What are the factors behind this?

Also from second quarter and beyond, should we expect the R&D expense to go up once again because it was lower in the first quarter? What is your outlook on R&D expenditure?

Thank you for the question. You're right, we did have a little timing on R&D in Q1.

Some of that was as a result of workforce reduction, we transitioned some of our products to capitalization. Importantly, we've really looked at the projects that are contributing to the growth in both divisions, and that's where we've focused our R&D dollars.

I wouldn't expect a material change other than what we've guided already for the balance of the year.

Thank you very much.

Perfect. Thank you.

I have a question on the China business. In yen terms, it appears to decline about 3%.

How much would be the decline in constant currency? That's my first question.

Then just want to confirm the FDA ship hold. I think you're saying that basically it will be lifted starting September 2027, right?

The quarter starting September 2027. Just wanted to confirm my understanding is correct.

Thank you.

Thank you. I did not say when the ship hold would be lifted.

I'll come to that second. I want to talk about China first.

It's important to put China in context for Olympus, because I talked about it being a nonlinear path back from decline, and I think it's important to remember that China remains a strategically important market for us. China records 4.8 million new cancer cases annually.

That's the highest in the world. It's more than the US and Japan combined.

These cancers are actually weighted towards GI cancers that we serve, with colorectum, stomach, esophageal, all in the top 10. If you think about the density of the endoscopists, it's like 1/10 of Japan, I share that with you because procedural access has structural room to expand.

Remember, the Chinese government is spending 9.2% of GDP on healthcare. Our strategy in China, which I've talked about on previous calls, is really clear, and it's built on four pillars: First, accelerate localization and begin to upgrade our local identity; two, transform our commercial model and redesign the service model to drive efficiency and better coverage; and revamp clinical engagements as well; and then get much closer at the policy level.

Those four pillars are how we're driving it. With respect to the decline, Michael, what was the actual percentage?

In constant currency, the decline for the China market was 17.3% for the quarter. Thank you.

Thank you for that. I do want to talk about the FDA broadly to ensure we're clear here.

Let me go back. We have submitted a comprehensive response to the FDA with our action plan, and we're diligently executing against that.

Now, completion timing varies by action item, but we work transparently with the FDA, and we update them on the completion of our actions. Importantly, we have really open lines of communication with the agency, if an issue comes up, we get it resolved.

Now, specifically to the warning letters, right, we, as I mentioned, transparent, open communication with the FDA to have them lifted as soon as possible. At the time of the last fall inspections, we had completed all the actions resulting from the warning letters, and in fact, an independent third-party assessment that was performed prior to the inspection concluded that our actions had in fact materially improved quality operations.

You'll remember that the warning letter and the import alert are tied also to the Aizu plant, and at the end of 2025, the FDA conducted eight inspections, but has not yet reinspected the Aizu plant. We don't know when the FDA will inspect Aizu, but now, we've been preparing all of our plants, including Aizu, for the inspections, and maintaining a state of inspection readiness.

The import alert is strongly linked to the Aizu warning letter, and so we would anticipate the resolution of the warning letter will be required to release the products on the import alert. Again, this represents, in terms of our total book of business, less than 1% of Olympus's products that are on import alert.

Even 1%'s important. Hopefully that clarifies where we are at with the FDA, as well as your first question on China.

Sure. On slide number 10, right, you mentioned that the majority of the ship hold affected products is expected to return to market in the second half of fiscal year...

Okay. Yes.

I thought you were referring to the import alert. The ship hold products, yes.

That's exactly what we expect in the second half of the year. Sorry, I thought you was referring to the import alert.

The ship hold, yes.

Second half of fiscal year 2027.

This fiscal year. That's right.

Okay.

Yeah.

This fiscal year. Okay.

Understood, yeah.

Yep. Thank you.

Great. Thank you.

First quarter US sales, that's what my question is about. From fourth quarter to first quarter, for two consecutive quarters, you have been quite strong, performing pretty well.

First quarter US performance was stronger than expected, or is it in line with your plan? That's the first part of the question.

Also, despite the fact that sales are so strong, why did the company issue a weak indication?

We actually exited Q4, as I mentioned, with a very strong order book, which is a leading indicator of our performance, both in North America and in Europe. We anticipated strength continuing based on the order book pipeline, we can go back and understand what might have happened there.

The second part of your question was, is this in line with our expectation? We had a very solid quarter.

We have high expectations, but this was a very good quarter. It's broadly in line with our expectations.

What we see is good products and good execution, but it's a long year. The reason we're holding guidance is it's too early to adjust, and as Michael said, as we get later in the year and get more visibility, we'll rethink about it, but we feel good about the strength of North America.

Yeah.

Thank you very much. My second question is about expenses, cost.

Elevate-associated costs and also 2,000 positions reduction cost. We had a lot of one-time cost in the last fiscal year, and for FY 2027, we believe that some of that expenses were still being incurred.

I think that was initial guidance. In the first quarter, position reduction and Elevate-related expenses, they were not incurred at all, or it's very small.

Elevate and also position reduction, these one-off costs, are they going to be incurred above what's included in the guidance, or have they already completely disappeared?

Not disappeared, but what our commitment to you was, is that in prior years we took quality costs below the line. Our commitment to you was that we would handle our quality-related expenses within the P&L, within the SG&A line, and still deliver 100-plus basis points of op margin improvement.

Michael, I'll have you add to this. I think the context I really want you to understand is that of course we continue to incur quality-related expenses.

We've become very focused on the management of our cost and trying to ensure that these don't become one-off costs below the line, but in fact they become part of the operation of the business within SG&A. Michael, if you want to add anything to that.

No, Bob. I think you hit the big points.

Just to maybe put a few numbers around it. Last year when we were [cough] finishing up Elevate, we finished the expenses associated with that in fiscal year '26, you're not going to see those in this year's plan, in this quarter or any future quarter.

As Bob said, the remediation efforts are being absorbed within our existing P&L. That's as it relates to the remediation efforts.

The operating model expenses also, for the large part, took place last year, in fiscal year '26. As we think about this year, as we spoke about when we opened this year a quarter ago, we talked about the sizable decline in expenses that were going to be taken below the line.

You should expect quarter-over-quarter this year to have a lot less expenses sitting in our op margin for P&L. I guess the quick version of this is that you should start to see the benefit from the operating model changes that we paid for last year.

The good news is, I think you're starting to see that in our P&L in quarter one, as you saw SG&A go backwards by 5.5% on a constant currency basis. You will not see those expenses, to a large part, go below the line in fiscal year '27.

Just to complete that story, we've been pretty clear that our focus is on delivering 100-plus basis points of op margin expansion, and one of the reasons we're going to be able to do this is every single cost pool within inside of Olympus is measured against the MedTech cost benchmark. If we're not on benchmark, we have teams working to get to benchmark, and that's just part of the renewed cost discipline that we're putting in place inside of Olympus.

Thank you for your question.

Thank you very much. That's all for me.

Congratulations on a very strong start to the year. I must admit I'm a bit sort of stupefied at the delta between my forecast and your actual number.

I'm sure you want to hear that. Then my question is the sustainability of the performance of the US endoscope division, because I seem to recall last year, first quarter was a pretty bad quarter because people are waiting for the EDOF scope to launch, and I think endoscopes were down quite a bit, I think something like 30% or so.

I also recall that endoscopes came back to growth in second quarter. My question is this: will we see strong growth in the US in the second quarter when the hurdle is much higher?

Thanks for the question. I'll have Keith kind of talk about the underlying dynamics.

As we don't give quarterly guidance, but I will tell you that what we look at is the order book along our key technologies to look at the health of that pipeline. The other thing that's coming along nicely as well is our operations team is ramping nicely with production, and customers are really valuing the technology.

It's just differentiated and it's important. Keith, why don't you add a little color around the US dynamics and what you're seeing there?

Thanks Bob. I think Bob hit a lot of the main points, but look, commercial execution in the United States ultimately keeps getting stronger.

We've got better pipeline discipline. We've been winning some IDN and ASC accounts.

Bob mentioned this, but we've got improved supply and availability, which is incredibly helpful for our commercial teams. I think what you really see here is the continuation of a strengthening kind of execution engine from our commercial team.

Like we said, Q1 tracked in line with our internal plan, and we expect the commercial team and the commercial execution to keep getting better as we go. The growth was really driven by EVIS X1, EDOF, our EUS demand, EUME3, Aplio, with a new ultrasound radial scope, and then our ET business with Viabil and Retentia.

It was a pretty broad-based growth for the quarter in North America. We still see the demand for EVIS X1 and EDOF, and as Bob said, our order pipeline looks really good.

Yeah. Thank you.

Let me just confirm the sort of a big growth in Europe is really coming out of the EDOF scope series, because I think those are priced double of normal scopes, and also the ultrasound scopes are also quite expensive. Would that explain this?

We think they're priced for value in the marketplace. Yes, we are able to get good value and good pricing on those scopes.

Second last question. Just, I think this is for Michael.

Could you walk us through the cadence of cost in first half and second half? I think you said something about second half cost increase, something about R&D costs, efficiency cost in second half.

I think there was a 10 billion yen positive impact from the head count reduction last year, at least that's what's coming for this year, and I don't know whether this is weighted toward the first half of the year. If you could walk us through what kind of costs we should expect in first half and second half positives and negatives, that'd be great.

Thank you.

Sure. Thanks for the question, and look, I think when we laid out the year, we kind of framed out how we were driving efficiency across the business through our enablement of the G-TOM, which we called our new operating model, and that went in effect April 1st.

We were able to see the start of that in Q1 play through, and really what that is is the 2,000 head count reductions that took place, predominantly most of those are now complete. As we talked about when we kind of launched this program, our expectation is that we'll see somewhere in the vicinity of 260 oku of savings in a full-out run rate.

Now, that won't happen until probably fiscal year '28 in the sense that we'll get a full annualization on some of the changes that we made in the operating model. We certainly expect to see a sizable impact this year from that savings as well to the tune of around 200 oku as well.

This year, as the impact of those changes take shape into the P&L. Hopefully that gives you some flavors to what we can expect there.

Look, the comment I made on R&D or Bob kind of highlighted in the opening around R&D is it's just natural timing, right? There's nothing, I would say, too much behind the numbers other than some of the timing as it relates to project spend that gets capitalized versus what's incurred on the P&L because of IFRS accounting.

I wouldn't read too much into that other than you'll see spending probably ramp up a bit in the second half of the year, which is what we typically see with program spend. Hopefully that helps give some clarity there.

No, I think the other thing in cadence that I would say is it's early. It's early, but you're starting to see the structural changes set the foundation for the productivity journey.

We've got business process optimization, better flexibility in our supply chain, and again, just this relentless drive to get to MedTech cost benchmark. Multiple things, but it's early.

We know we earn credibility a quarter at a time, so, but it's a solid start.

Got it. Thanks a bunch.

Thank you for taking my question. Let me ask about the outlook for the adjusted operating margin for GIS.

The first quarter number was 23.3%, I think, which is almost near level of the full year guidance. I think usually the margin improves from the second quarter onward as a revenue seasonality of this segment.

Is this high margin due to strong performance in the US markets, or what should we expect the revenue different seasonal trends for this fiscal year? Thank you.

You want to take that, Michael?

Look, and I think we were very, very pleased with the way the business started. As you look at our mix of sales regionally, certainly that has an impact on the mix impact from a P&L perspective.

As we talk about the remainder of the year and how we see revenue playing through by region, we would expect to have similar, I would say similar results by region throughout this year, which, again is a positive when we think about how the margin will play through at gross margin. Again, I think the other part that I just talked about in my last comment was around the timing of expenses.

I don't think it's fair to say you're going to take a run rate a quarter and then multiply by four. That's probably not how the year is going to play out from a spending perspective, as we have structured programs that will ramp up throughout the year.

I think as far as the impact from a gross margin perspective that you're seeing across that business, that's something that I think will continue to see positivity as we move forward.

Thank you so much. Let me ask one follow-up questions regarding the progress toward the full year guidance.

For the impact from the shipment holds, the first quarter number of 13 billion yen revenue impact from the ship holds, could you confirm if this figure align with your initial plan, and it was primarily concentrated within the SIS segment? Additionally, do we expect this impact to continue in the second quarter as well, and diminish significantly starting from the third quarter?

Thank you for the question. I won't give specific kind of quarter-to-quarter guidance on the ship holds, but broadly, that's correct.

What we saw in the first quarter was what we expected, and you're right that those ship holds, which by the way, were proactive management-led decisions, were largely concentrated in SIS, and we expect those to be alleviated in the second half of the year. What you'd expect is what you stated is broadly correct, which is we did what we said we were going to do in the first quarter, we think the planning and the ship holds, we're making good progress on those, and it will be as we suggested in our full year guide.

Thank you so much.

Can I ask about the progress of the surgical business review, which was published by you guys back in May? I know it might be a little bit too early to tell, but if it's possible, would you please provide some sort of update regarding timeline and the scope that might be coming up going forward?

Then I have one follow-up question on that. Thank you.

Thank you for the question. As it relates to the surgical strategic review, as I mentioned in my commentary, the review is progressing well.

No conclusions have been reached, and there's no predetermined outcome. I absolutely will inform you should a material event happen and we reach that point.

Again, I put this in context of our focus is always on delivering value to our shareholders through growth, profitability, capital efficiency, and long-term value creation. When we think about capital deployment since I've joined, we've talked about making sure the portfolio is in the right shape.

No new news on the surgical review, no specific timing yet, but we're approaching it with rigor, objectivity, and speed. We'll make a prompt announcement if anything material comes up that requires a disclosure.

Thank you. The next question I ask Michael.

You joined Olympus back in probably April, you spent three, four months since then. Based on your observation since you're joining the firm, have you found any kind of some room for you to streamline your businesses in order for you guys to be more efficient and profitable?

Thank you.

Thank you for the question. It's been a few months, for sure, and it's been an exciting start to the position here at Olympus.

Look, it's super exciting, and everything I thought it was going to be from a perspective of foundational business and excellence and from a product perspective, and just from a sales execution perspective. You can start to see that the business is on sound footing from our last couple of quarters of performance.

Look, with that said, obviously, the team has done some really good work. Obviously, we did the operating model change starting this year, where we were able to streamline our operations, how we rotated our business to line up behind the divisions and businesses versus the regions.

As such, we were able to eliminate some of the, I would say, redundancies across the company. In addition to that, we have orders and kind of how we're looking at running our business that we want to be best-in-class in MedTech, and certainly we have opportunities to do better.

When we think about our expenses as it compares to our MedTech industry peers, there's room for improvement. Look, we're going to take one step at a time, but we're going to be marching toward those benchmarks over the coming quarters on the P&L.

Look, on the balance sheet, there is also opportunities for us to continue to release cash to our shareholders. If you think about cash conversion cycle, certainly opportunities there, and we'll be working towards improvement there.

Look, I'm excited to be here. I think excited to be here speaking to the results that we have this quarter as well, and certainly look forward to the opportunities to continue to bring value to our shareholders with the improvements that we have planned in the future here.

Fair to say, it was a solid start, and we deliver every quarter, right? It's

early in the year.

We think there's opportunities. We certainly haven't run out of good ideas or opportunities to pursue,

but

we've got to work, and we've got to deliver every quarter. That's our focus.

Thank you.

Thank you very much for taking my question. I got one question on SIS segment.

I know that this segment is mostly disrupted by the ship and hold and export ban, but I can see that the US business is pretty strong. How you manage to come up with this strong results?

Is there any one-off impact, or you kind of doing some measures to overcome the negative impact from the ship and hold and export ban? Also sustainability of this mainly US business after the second quarter.

Thank you very much.

Thanks. I'm going to have Seiji add some detail here.

You're right to point out that when you think about SIS, we have a number of franchises, and two of which, urology and respiratory, are very good businesses and very good markets, and you saw that from the growth that they occurred in Q1. Seiji, I think you offering some comments on what you're seeing in the US particularly would be great.

Thank you very much for your questions. Besides with ship hold, in SIS, in urology, in respiratory, in keep strong demands, and we could report a strong performance in our first quarter.

Especially urology, the resectionist keep in a good sales, and also, especially respiratory area, the EBUS system is a keep strong growth, as well as the consumable business, which we can sell, which combined with EBUS, which means needle, that's a strong sales. Those strong segment we have, and that overcome to the impact of the ship hold.

Again, as Bob mentioned, in second quarter, some of our key product will return to the market, expect we back on track in the full years. Thank you.

Thanks, Seiji.

Can I ask a follow-up question on urology? What's particularly strong in the US market for urology, BPH or a stone?

If you could specify.

Thank you. Actually both, the stone resection and then also the stone for the laser.

Those two is the key lever of our growth in the US market.

Okay. Thank you very much.

Thank you.

Thank you.

What I want to ask is about the GIS quarterly change for this years. It used to be the case in the second quarter and the fourth quarter, specifically the fourth quarter, it tends to record higher sales.

For this fiscal year, it seems to be the case that in terms of the volatility by quarter has smoothed out. Is that the correct way to understand that?

If the first quarter last fiscal year, on the constant currency basis, the US was minus 18%. For this fiscal year, in the first quarter, you said that it was in line with your plan.

On the other hand, the fourth quarter last fiscal year, the North America was strong. For this fiscal year, does it mean that the fourth quarter won't generate a high level of sales compared to previous years?

Thank you for the question. When you think about last year, we had a lot going on in the business.

We had a lot going on in North America relative to EDOF scope availability, we had operational challenges, and so what you started to see us in Q4 deliver nice double-digit growth in the core business, we continued that in Q1. Of course, as the quarter goes on, the comps get a little different.

I would say, we anticipate GIS being our key growth engine for us throughout the year, and there's nothing that tells us that we won't go. Now, of course, quarter-on-quarter is a little bit different, but I would draw you back to the reason we didn't change our full year guidance is we have some other headwinds that I've talked about, China and some other things still moving back, but we like the start.

We have confidence in our full year plan.

Thank you. My second question is about the US the impact on the US tariff.

For the first quarter, one of one-off, I would like to ask, if you look at page 22 of the presentation, there is a slide that talks about this this, about this is waterfall chart. In terms of this one-off, that was different from the internal plan, specifically about tariffs, can you talk about those numbers?

I'll start, then Michael jump in here. When you think about the way we planned the year for tariffs, we assumed a 15% tariff, largely a US tariff.

There's obviously other tariffs involved, and this is a dynamic situation. Now, you've seen the news, it could be 10%, could be 12.5%.

Potentially, there's some upside there. Look, our job is to manage this through.

Michael, if you want to add any specifics there. Largely, the way we planned the year was at a 15%, and it's getting a little bit better than what we thought.

I think that's fair. Just the comment that we have in the slide here references the fact that we built our tariff plan a bit conservative at a 15% rate, and obviously what we saw in Q1 was a little bit better than that, which is good.

Obviously, that's a good thing, and we just saw the results of Section 301 come out, which for our business means that the tariffs will be somewhere between 10% and 12.5% going forward, depending on the country. That's a good thing, considering our plan was based at 15%.

Certainly some upside there from a GP perspective, which I don't know if you can see that in the slide or not, but essentially it's helping offset some of the other inflationary pressures that we're seeing, given the macroeconomic environment right now. Hopefully that helps give a little bit of color on the tariff impact that's hitting our P&L.

Thank you very much. You don't disclose the actual number, the actual amount, do you?

For quarterly, no. What we've done conservatively to plan for the year is we put roughly 23 billion yen in our plan for tariffs for the year.

That kind of represents that 15% number we talked about, but we don't talk quarter-over-quarter what's happening with tariff impacts.

Thank you very much. I would like to confirm, the first quarter SG&A plus 7.3 billion yen, how much was better than your expectations?

You talked about some timing differences, but you don't disclose that number? I want to confirm about that.

We're not going to disclose how much is timing versus benefit that we've generated through operating model efficiencies. I think it's fair to say that we had a good start to the year.

We are more or less aligned with the plan that we had put in place and feel good that the remainder of the year will be in order of magnitude similar as we think about productivity from our op margin.

Understood. Thank you very much.

That's all for me.