Olympus Corp

TSE:7733

Earnings Call Transcript 2022-Q2

[Chikashi Takeda, executive]

Thank you. Greetings. I'm Chikashi Takeda, CFO. Thank you for participating in this Financial Briefing for the Second Quarter of Fiscal 2022 of Olympus Corporation.

I would like to provide a review of our consolidated financial results for the second quarter as well as our full year forecast for FY 2022. Please turn to Slide 3. Highlights of our consolidated financial results for the second quarter of fiscal year 2022. Starting with the revenue. We achieved significant growth of 31% in the first 6 months, driven by Medical. Even compared with 2020, it was double-digit growth of 12%, well above the pre-pandemic level. In addition to higher revenue, we continue to optimize SG&A expenses and achieved operating margin of 18.5%, record highs for both amount and ratio for our second quarter and first 6 months. Focusing only on the second quarter, 3 months, operating margin was 22%, marking a steady progress toward achieving KPIs we set forth in our corporate strategy.

Next, full year forecast. In light of the first 6 months performance and market recovery, we have revised upward our revenue forecast. Even after factoring in the expenses for the reorganization of the scientific solutions, SSD, we expect to continue to achieve record-high operating profit in terms of both amount and ratio. We now forecast 17% growth in revenue and an operating margin of 16.8%, 5.6 points improvement year-on-year.

Next, the consolidated financial results and business review for the second quarter of FY 2022. Please turn to Slide 5. Consolidated revenue totaled JPY 413.1 billion. In response to market recovery, revenue increased in all businesses, particularly in Medical, resulting in growth of 31%. In comparison to FY 2020, revenue was 12% higher, well above the pre-pandemic level.

Gross profit was JPY 270.3 billion with gross margin improving 3.5 points driven by higher revenue, improved factory operation rate, and the absence of voluntary recall cost for endoscopic products, which were recorded in the previous year. SG&A expenses were JPY 191.5 billion with SG&A ratio improving 4.6 points to 46.4% owing to relaxation of restrictions on sales activities, strengthening of our operational infrastructure, and measures to improve profitability. And therefore, SG&A expenses increased in amount, but we managed to keep the ratio at 46.4%.

Operating profit was JPY 76.3 billion with operating margin of 18.5%, improvement of 8.9 percentage points. We have been disclosing quarterly financial reports since FY 2009, and these results represent record highs, both in amount and ratio for second quarter and for 6 months. For the second quarter, operating margin was 22% making a steady progress toward achieving KPIs we set forth in our corporate strategy 2 years ago. Profit attributable to owners of parent was JPY 62.4 billion, up JPY 85.1 billion. Last year, a loss associated with the transfer of the Imaging business was included. And this year marked a dramatic improvement year-on-year.

Please turn to Slide 6, details of each business segment. First, Endoscopic Solutions Division, ESD. Revenue totaled JPY 220.6 billion, up 29%. Operating profit was JPY 61.6 billion with operating margin at 27.9%. Expenses increased due to relaxation of restrictions on sales activities, and we recorded an impairment loss of JPY 1.6 billion associated with the equity-method affiliate in Europe. However, those expenses were offset by revenue growth led by an increase in sales in GI endoscope resulting in a significant improvement in operating profit.

For business review, I would like to focus on the 3-month period, July to September. Compared with the same period of the previous year, which was impacted by COVID-19, the market environment improved and we grew across all sub-segments. We achieved 8% growth over FY 2020 on a managerial basis for your reference.

In GI endoscope, revenue grew in all regions with strong performance in North America, Europe, and China. By product, EVIS X1, our new GI endoscopy system as well as previous generation gastroscopes and colonoscopes contributed to sales increase. Also, please note that sales contribution of EVIS X1 has steadily increased and now accounts for approximately 10% of the GI endoscope sub-segment.

In Surgical endoscope, we saw strong performance in Japan and in North America driven by surgical endoscopy system, VISERA ELITE II. And sales increased. In Medical service, revenue grew across regions due to stable revenue stream based on service contracts including maintenance service, an increase in new contracts, and recovery in the number of repairs from the pandemic-related decline.

Slide 7, Therapeutic Solutions Division or TSD. Revenue totaled JPY 133.1 billion, up 31%. Operating profit was JPY 30.3 billion, operating margin, 22.7%. Despite an increase in expenses due to relaxation of restrictions on sales activities, both operating profit and margin improved substantially due to revenue growth coupled with improved gross margin due to the absence of voluntary recall costs of JPY 5.9 billion recorded last year as well as gain of JPY 2.8 billion in other income associated with the phased acquisition of Medi-Tate.

For the business review, I would like to focus on the second quarter, the 3-month period. We grew across all sub-segments thanks to market recovery from COVID-19. We achieved 5% growth over FY 2020 on a managerial basis for your reference, which exceeded the pre-pandemic level. In GI endotherapy, we saw growth across all regions with a number of procedures recovering. Strong performance in Europe and China was notable. Notable momentum in products for ERCP, endoscopic retrograde cholangiopancreatography used in endoscopic diagnosis and treatment pancreatic ducts and the bile ducts; sampling, biopsy forceps steps; and ESD, Endoscopic Submucosal Dissection and EMR Endoscopic Mucosal Resection.

In Urology, growth continued particularly in North America where the number of procedures is on the recovery, led by strong momentum in resection electrodes of BPH, Benign Prostatic Hyperplasia and SOLTIVE, SuperPulsed Laser System, a lithotripsy solution for urinary stones. In Respiratory, growth was driven by North America due to market recovery, revenue from Veran Medical Technologies, and strong momentum in bronchoscopes and endotherapy products for EBUS-TBNA. In other therapeutic areas, there was strong performance in gynecology and ENT. In particular, ENT endoscopes made a contribution.

Slide 8 for Scientific Solutions Division, SSD. Revenue amounted to JPY 53.2 billion, up 32%. Operating profit was 6.5% -- or JPY 6.5 billion with operating margin of 12.2%. Operating profit made a considerable improvement due mainly to revenue recovery, coupled with improved factory operation rate and cost control. For the business review, I would like to focus on the second quarter, the July to September quarter. We grew both sub-segments thanks to market recovery from COVID-19. Compared with fiscal 2020 on a managerial basis for your reference, revenue declined 2% still under the pre-pandemic level due in part to a slow recovery in demand for industrial videoscopes and non-destructive testing equipment used in the aircraft industry and others.

In Life science, growth was driven by market recovery and improved budget execution at research institutes and universities with notable strength in Japan where supplementary budgets were executed and large orders were received. In Industrial, we grew in all fields driven by market recovery led by improved CapEx sentiment. Notable strength in industrial microscopes in China, driven by 5G-related electronic components and semiconductor markets. Non-destructive testing instruments, driven by market recovery and X-ray fluorescence analyzers boosted by high gold prices and strong recycling market of precious metals.

So that was the summary of the business situations. Please go to Page 9, Slide 9 for the financial position as of the end of September 2021. There was no major change from the end of June. Goodwill and intangible assets increased from the end of the previous year due to the acquisition of Medi-Tate. The equity ratio rose 4.3 percent points to 37.6% from the end of the previous year due to the decline in interest-bearing debt. And also, cancellation of approximately 72 million treasury shares was made in June.

Please turn to Page 10 for the status of cash flows. Cash flow from operating activities was JPY 68.8 billion, up 84% year-on-year. Offsetting the -- there was an increase significantly due to improving -- improved profit and the one-off expenditure of JPY 10 billion on the reversal of the provision for the career support for the outplacement activity, but that was offset by the positive factor.

And cash flow from investing activities increased JPY 19.8 billion and including the decrease in time deposits from JPY 40 billion in the previous year. There was a decrease of JPY 20.2 billion due to -- in part to the expenditure of JPY 21.3 billion associated with the acquisition of Medi-Tate. Free cash flow stood at JPY 18.4 billion. It was JPY 49.7 billion, we exclude -- if we exclude the expenditures for the reversal of the provision for the career support for outplacement program and the acquisition of Medi-Tate.

Cash flow from financing activities declined JPY 125.3 billion, a minus JPY 44.1 billion due mainly to the debt repayment and dividend payments. And the absence of the -- due to the absence of the large amount of financing last year due to COVID-19. As a result, cash and cash equivalent in September stood at JPY 193.4 billion, a decrease of JPY 17.1 billion.

Next, I would like to explain our full year forecast for fiscal year 2022. Please turn to Slide 12. In light of the first half results and market recovery, we revised up our full year revenue and operating profit forecast for fiscal year 2022 by JPY 26 billion and JPY 4 billion, respectively, for revenue and operating profit from the August announcement. We now forecast revenue to grow 17% year-on-year to JPY 856 billion. Although we expect the expenses for the SSD reorganization, we forecast an operating profit of JPY 144 billion with an operating margin of 16.8% driven by continued cost control and efforts to increase SG&A efficiency.

We also forecast profit attributable to owners of parent of JPY 109 billion, a record high for us. Compared with the pre-pandemic fiscal 2020, these forecasts represent 13% growth in revenue, 56% growth in operating profit, and 4.6 percent point improvement in operating margin. We plan to pay a dividend of JPY 14 per share for the fiscal year, unchanged from the May announcement. The ForEx assumptions are JPY 110 per dollar and JPY 130 per euro.

Please turn to Slide 13 for forecasts by business segment. In light of the first half results, the 6 months and the market for -- the last 6 months and the market recovery, our forecasts have been revised upward in ESD, TSD, and SSD. In particular, Medical businesses including ESD and TSD is expected to grow 14% in revenue and 34% in OP even compared with the pre-pandemic fiscal year 2020, and is expected to achieve record highs in revenue and operating profit. In terms of elimination and corporate, we have been made -- making revisions for -- including expenses for the SSD reorganization.

Lastly, I would like to highlight the -- some of the initiatives we are pursuing to become a truly global medtech company. Please turn to Slide 15 for the SSD product pipeline -- sorry, ESD product pipeline. Well, there are no major changes from the previous quarter, EVIS X1 has steadily gained momentum in Europe, Japan, and some parts of Asia. We are making every effort to obtain approvals and launch the product in regions where we haven't launched yet. In the meantime, in the United States, we are seeing solid performances in duodenoscope with detachable end-cap thanks to the efforts to switch from the old models.

Please go to Slide 16 for the TSD product pipeline. The GI endotherapy is committed to steadily expanding product lineup for various procedures in each market. Urology is seeing strong momentum in SOLTIVE, SuperPulsed Laser System, a new lithotripsy solution for urinary stones. Respiratory is driven by the lineup of bronchoscopes and EBUS scopes, including new products, and that is aiming to expand lung cancer portfolio by introducing a new software for electromagnetic navigation system, which could improve the workflow of bronchoscopy by designing complex bronchoscopy procedures and optimal routes to peripheral pulmonary lesions.

Please go to Slide 17. Our theme for fiscal year 2022 is to further strengthen our position as a global medtech company by stabilizing the corporate transformation we have carried out last year. I would like to explain the progress so far made during Q2. First, the reorganization of SSD. We made a disclosure today on the reorganization while considering all options including potential business transfer.

Next is the GBS, Global Business Services. It is shifting our unique and high confidentiality functions to captive shared service center centers in China, Poland, and the United States, and routine standardized functions to China, India, and Malaysia through BPO, Business Process Outsourcing to Europe. The transfer to shared service center in Europe has been largely done. In Japan, China, and some parts of Asia, this year the transfer of some finance and procurement functions was completed in September to kick off BPO from Japan to Dalian, China. So this has been already completed. The work has been already starting. Olympus Asia Pacific business management services, Dalian, our captive shared service center was established in Dalian, China, and we are working for the official opening of the center in December this year.

Next, transfer of Olympus Systems Corporation to Accenture. Based on an agreement signed in June, the transfer of all shares was completed at the end of August. As of the transfer contract, we signed an outsourcing agreement as part of the agreement covering application development, maintenance, and operation of the core business system and so forth. This is part of our efforts to build a global IT infrastructure and bolster our organizational strengths while optimizing long-term IT costs. Lastly, the establishment of a corporate venture capital fund. Through recently the established Olympus Innovation Ventures, we will invest a total of USD50 million over the next 5 years in early-stage promising companies with differentiating technologies across the globe.

Lastly, please turn to Slide 18. We would like to invite you to Investor Day 2021, which will be held next month. The event will be virtual, starting at 6:00 p.m. Japan time, December 7. We plan to review our progress since Transformation Olympus was announced back in 2019, and we will talk about the future direction of the Medical business and our current corporate strategy as well. Details will be provided later. We look forward to your participation in this event.

With this, I would like to conclude my presentation. Thank you very much for your attention.

[Chikashi Takeda, executive]

Thank you very much. Now we would like to begin the Q&A session.

I'm looking at the results for July, September period, how did that compare to your forecast? And I suppose that is reflected in your revised forecast, so can you also explain the difference for the second half? In revenue and profit, I think they were both good during the second quarter. So how good were they and what were the drivers? And as for the assumptions for the second half, if possible, can you talk about the changes from 3 months ago? I suppose you have revised the revenue forecast upward, but for profit I think there will be additional expenses in relation to SSD reorganization. So I think there are some cost increase factors as well. So including that, can you give us the details?

Thank you for your questions. First, on a quarterly basis forecast, we do not disclose those. But internally, of course, we are managing the figures, numbers. In a nutshell, the managerial numbers were exceeded in terms of the results for the first half. Overall, that was true, but in particular in the Americas, the U.S. market in particular, the results exceeded our projections up to now at least.

And if possible -- thank you. So if possible, compared to your internal forecast, JPY 10 billion overshoot I think. So if you can at least talk about the operating profit what the differences were on a quarterly basis or for six months?

Would 6 months suffice?

Yes. I think you revised the forecast in August. So I think we're talking about the difference for the second quarter.

Right. Revenue basically made a difference. Slightly lower, now trending slightly downward. Operating profit was -- other income and expenses were kind of tricky. So I'm going to exclude that. We're talking about 0.1, 0.2 difference in terms of operating profit margin. That is the percentage point difference.

I see, I'm not sure I follow you, but -- so there was not much upside compared to your forecast, correct?

Yes. A slight upside over the forecast.

I'm going to keep it at that. Thank you. So I'm afraid you can't explain quantitatively, but for the first half there was no big substantial upside.

That is true. As far as the bottom line is concerned, there was an improvement or upside to a certain extent.

Okay. My second question is on revenue in China. At the last meeting, I think you talked about the impact of the Chinese policy favoring the domestically supplied products and I think that was a factor that was mentioned as a concern. But looking at the supplement, I think for both ESD and TSD, the numbers improved. So what were the difference from Q1 to Q2? And do you think that this favorable condition will be sustained in the second half as well?

China. I think you're talking about Buy China policy. In Q1, individually, they were like anecdotal events, but the impact was not substantial. In addition, in Q2, should I say, we continue to see a situation where no major impact was felt. So no major impact either in Q1 or Q2. To put it differently, the figures that we are showing reflects that. We continue not to see the impact but on the anecdotal basis, we see some of the impact being felt. That is what we hear, but they are not having a major impact on our financial performance. So on ESD, the quarterly revenue until last year was around JPY 16 billion for Q1, JPY 13.7 billion and JPY 21.7 billion in the second quarter, which is higher than previously, JPY 21.1 billion.

Is this due to a -- like a pent-up demand, or do you think it is actually improving? If you don't know, that's fine.

Well, for Q1, we don't have the specific figures on hand. But basically, on a 6-month basis, for endoscopy, CV-290 and GI scopes this continue to enjoy strong business.

In the medical business for the second quarter, the sales were very strong and OP was 33% on a virtual basis. This is unprecedentedly high, I think. Was there any reason in the environment, or is it because of the sales mix? The EVIS X1, there was a 10% increase in new products, I think that was a contribution. For example, in the U.S., for the colonoscopy, the screening age was lowered to 45 years old and there was some changes in those colon testing. Was that a cause? Or is it because of the sales mix -- scope mix is increasing in the total sales? Was there any one-time factor, I suppose, other than those regular factors?

As you can see on the slide, I think this is pretty much a summary. X1 has grown, that is one factor. And if I add more comments for X1, the high-end product including X1 -- so we were able to increase the X1 sales and high-end sales without compromising on the sales of the older models, one generation before. And in terms of the scope sales especially in terms of the sales mix, the mix of scopes in the total sales is increasing more than we had anticipated in the United States. For the colon to duodenoscopes, those scopes have been growing. So that's another factor. There are other factors as well, but those are the major factors. And I agree with you, your explanation is correct. So that's what the numbers reflect. As you said, in terms of the background, Nacho Abia is here with us. So I would like to let him speak. Nacho san, could you just give us additional explanation?

[Nacho Abia, executive]

This is Nacho Abia speaking. I think there is not much to add to what you say. The -- we are seeing recovery in all markets and almost in all procedures, maybe not 100% at the level of 2020 yet, but with the speedy recovery. And as per capital sales, we also have seen some return to normality in the purchase pattern of our customers. And we hope this will continue as we believe that the recovery is real and it's factual. There is not one specific item that is driving and it is the overall recovery of the business. Thank you.

[Chikashi Takeda, executive]

So that was all comments we have.

Regarding the strong trend, I don't mean to complain about the strong trend, but compared with the expectation as of the end of -- the beginning of the year, you had a very conservative forecast because of the delayed shipment of EDOF and there were some customers refraining from purchasing new equipment, what happened to those factors?

In May -- as of May, well, I use the word conservative very often for -- especially for ESD in the May announcement. Especially for Japan and the United States, we were having a very conservative view on those markets. I think that's what I said at that time. Regarding Japan, the impact of COVID is appearing with some delay compared with the trends in other countries. That's why we have come up with a conservative forecast. But now today, for Japan, still we see some -- in terms of the tonality, the analysis of our people in the field is that in terms of the number of procedures, the volume has not gone back to the completely normal situation yet. But if you look at the current trend in September and October, there is a strong recovery. Therefore, our view of the market has been somewhat updated these days. And as for the U.S. market, the endoscope system is in its ninth year and basically, the major trend has not changed. But when it comes to scopes, compared with our expectations, we have some outperformance in sales and revenues. Therefore -- so this is a little bit different from our original view. So these trends are stronger. So for the last 6 months and also for the next 6 months, we believe that the current strong trend is going to impact. Nacho, could you add to my comments? Do you have anything to add, Nacho san?

[Nacho Abia, executive]

Yes. Thank you, Chikashi. And what I can add is that with -- at the beginning of the year, we were still in the middle of the Delta variant of the COVID-19 situation surge and it was difficult to predict what was going to happen. At that time, due to the Delta variant as I explained, some -- we already saw some cancellations again of some procedures in some areas. And this was what -- the reason that at the beginning of the year, we were a little bit more prudent in our assumptions for the full year. As the year has progressed, and we have seen the progress on vaccination and the return to normality of most of our customers or to high level of normality, we have seen the recovery pretty much all over the country. Additionally, obviously, the EVIS X1, the new platform is performing very well as expected, and after we have some delays with the EDOF model as was announced. But once the model was back in the market in the month of July, we've seen clearly a very, very important response from our customers that were waiting for these products. So I think overall, it's a combination of a strong performance of the EVIS X1 platform and a recovery in the market that it has been better than what we were anticipating at the beginning of the year. Thank you.

[Chikashi Takeda, executive]

Understood. Thank you very much. Regarding the content of Investor Day, Olympus Business Service, you mentioned it. It's just one line, but it was an impactful comment, so could you explain in detail what this is about? And also, regarding TSD growth strategy, can I expect more details to come out in the Investor Day?

Thank you very much for your comment. Basically, there will be a review that we are making because it's been 2 years since we have announced the business strategy -- management strategy. So -- where we announced the sets of different strategies and actions. And basically, based on those strategies and actions, we have been promoting the business. We are not covering all of them in the Investor Day presentation, but we will have a general review of everything that is in the menu. On top of that, within that framework, there may be some new aspects of the growth strategy of the Medical business. So as an additional element, we would like to touch upon that as well. That's what we are planning to do for the Investor Day. Regarding GBS, so more or less for GBS in terms of the growth strategy, this will be the focus rather than everything else. So for GBS, we will be focusing on that. Of course, we will talk about the rationalization and efforts to improve efficiency that was included 2 years ago. But rather than that, we would like to focus more on the growth strategy. So we like to allocate more time and efforts for that part.

Understood. Thank you. Included in the growth strategy is TSD?

Yes, I can say that. For those two core businesses, we don't -- we have no reason not to mention those.

I'll try to ask only one question. Looking at the materials, the supplementary on Page 5 because I want to compare Q1 and Q2. When we look at Q2 results for ESD and TSD, for both overwhelmingly, the growth came from China and as was touched upon earlier, and you mentioned this in the last meeting as well. May, the Finance Ministry, we believe that issued the announcement regarding the Buy China, I think 15 items were listed there and yet the China portion is increasing. And I'm wondering why because the Chinese government is saying that game is a drug. So does it mean that the customers are ignoring the government policy, not that customers themselves are changing? Is that the reason why your China business is growing?

Well, I cannot speak on behalf of the customers who are buying our products, but as you indicated, from the government there are guidelines and they are specific items listed up, that is true. For example, on the other hand, from Olympus' point of view for endoscopy business, so far, our products are well appreciated. In other words, they are like in terms of performance and functions, functionality, the local suppliers in China cannot compete or cannot compare to the products that we offer. That is how we interpret the situation. And I don't know if we are the right ones to mention this, but -- so there are government guidelines and how to manage that, comply with that, I think the government entities that issued the guidelines and the recipients of this looks like in terms of the interpretation, operation, there are some gaps. We're -- are being told that those are the things that are happening on the field -- at the field. I'm afraid that's about all that I can say. But Nacho, maybe you can add any additional comments?

[Nacho Abia, executive]

Yes, Chikashi. I can. Thank you. I think the situation, the Buy China policy and also the volume-based procurement in policy that we are seeing, obviously we understand that the intention of the Chinese government. And as Chikashi saying, we cannot speak from our customers. What our understanding is, is number one, as Chikashi say, the interpretation of the Buy China guideline is not completely homogeneous all over China. And there's different interpretations. And in some cases, there is also the component of how much a company like us is collaborating with the health care system and working with the physicians in order to improve patient care.

And my personal opinion is that as much as the Chinese government cares about the Buy China policy, I'm pretty sure that also it's important the well-being of the Chinese patients. And in those cases, is when the healthcare institutions make their decisions to buy as well, not having in consideration the Buy China guideline, but also having in consideration what is the best product to treat their patients. We believe that the Buy China and other policies like this will continue in China. And our strategy has been solid and has been working from the -- from many years ago and it's not changing, right? So we will continue supporting the physician, we will continue bringing superior technologies, and we will continue trying to bring in evidence to the market that our products can deliver better clinical outcome.

And also, I mean, sometimes the value of product cannot only be measure based on the acquisition price, but also based on cost of ownership associated to that based on the quality of the product, the repairs that they have to accomplish, et cetera. And I think we will continue working with our customers trying to show them that our products are not only clinically better but also in the total cost of ownership is also efficient for the healthcare institution. So I think for all these factors, we still see that our business in China is doing well, and we will continue observing and collaborating with our customers in China for this purpose. Thank you.

[Chikashi Takeda, executive]

Very clear. Thank you. So a follow-up question. So it means that the customer profile is not changing. It's not customers changing from public to private, correct?

Yes, that is correct. Yes. That would be the correct understanding.

A very positive performance and upward revision was announced this time. There are some concerns you may have, so I want to ask you about those. In the medical equipment market, there were many things. Yesterday, Terumo mentioned it in their announcement, there were some risk factors in the medical equipment market. For example, well, among them maybe impactful for your company or not so impactful for your company. So please let me know the nuances of those. And also, in the guidance you have announced, how did you incorporate or reflect those factors' concerns? That's what I want to understand. For example, transportation cost like shipping cost and airfreight cost, they are increasing, what is the impact on your business and the raw material costs including the cost for crude oil is increasing. And also in the U.S. and North America, there is a competition of labor force, and also semiconductor supply chain issue may also impact you. So on those risk factors, what will be the specific impact on your company? And how did you reflect loss in your guidance you have just announced?

Thank you very much. Regarding semiconductor issue and others like parts and components and the transportation costs, of course, there's concerns. We do recognize those concerns. So different from in the past. In terms of pricing, we may have to transact at prices that are different from in the past. So that's what we are thinking. Having said that, for each one of those concerns, there may be actions we can take for semiconductors. I don't think any company has any definitive action they can take, but the people are taking different actions against that negative factors. By responding honestly towards those negative factors, we came up with the guidance that we have just announced as a result of that. So because of those negative factors, our raw cost -- raw material cost percentage or cost to sales has not deteriorated so much so far yet. So that is the conclusion, I think.

And in terms of the semiconductors, for this fiscal year, our procurement department has been making tenacious efforts in negotiations and so forth. And in terms of the pricing, in terms of the negotiations, sometimes they may have to make a compromise, but they tried to maintain the long-term contracts as much as possible. And also, in terms of the procurement, we have secured the necessary stock, the parts and components that we need for now, for the time being. So there is no major impact on our business from those factors. However, if those factors linger for over a long time, of course sooner or later the impact may have to be taken into account. For example, for the next fiscal year, our performance may be impacted. I can't deny the possibility completely. But for this, if you ask us how much I think that's what you want to understand. Internally, we are trying to figure out the situation so that we can have an accurate forecast. Especially for next year May, we are going to show you the forecast. So how to reflect those factors into that forecast. If the situation turns out to be serious, we have to reflect that in the forecast to be announced in May next year. That's all. Thank you.

For each of those factors mentioned, there may be major factors for you or minor factors for you like ships and planes, there may be differences, and between the crude oil and the semiconductors, there may be different implications for your company. So could you give us some more color? So which ones are more impactful for your companies or which ones are more negligible, if I may? Could you mention that?

Well, semiconductors are used in many of our products, so that is a key component. So quantitatively, I can't tell you exact impact how much it is, but for the management team, that is one of the factors that we are most focused on.

Understood. The second question is also about the risk factors. The number of operations and procedures, there is some slowness in the recovery trend, but we think that we can expect the recovery going forward. But on the other hand, because of the lack of staff members, the recovery in the number of procedures may become slow -- slower than we had expected. So how do you see -- what is your view on the recovery trend of the number of procedures for the endoscope test procedures? What is your forecast going forward? So if you could quantify the future trend of the procedures that would be great in terms of exams as well.

Well, Nacho is here with us. So he is monitoring this market closely. And although we have some data, but I would like to let Nacho Abia answer your question. Nacho san, could you answer the question?

[Nacho Abia, executive]

Yes. Thank you, Takeda San. I think that -- I mean, I don't know how specific I can be in giving you an answer. I believe -- well if we are observing from the market is that all the critical care procedures have returned to normality. And we believe that this trend will continue. Most of the healthcare systems across the world including in countries where still vaccination rates are not very high, still we see that the activity at the hospital, especially for critical care is obviously returning to normal. We know that there are still some specialties like ENT or preventive colonoscopies, which still are not at the level of fiscal year '20, but we also see and talking with our customers and with the societies, they are also positive that step-by-step it will be back to the normal levels of 2020. But I think that it's -- all this is subject to the assumption that the COVID-19 situation is going to continue in the current positive trend, and we will see less and less infections cases all over the world.

As for the staff shortage is indeed something that we are hearing from our customers. I think is indeed a reality, especially in the U.S. market that there are issues on staffing. As far as we know, there is some -- we have heard about some delays in procedures, but not cancellations. And obviously, the healthcare providers are working very hard in order to staff appropriately their organizations to continue doing those procedures. At the end of the day, the healthcare demand will continue, and our customers will need to find a way to provide their services. So I think in our view, the recovery of the procedures is solid. And for those areas where are not critical and maybe are not yet at the 100% level previous dynamic, we will see the recovery over the coming months. Thank you.

[Chikashi Takeda, executive]

A question on TSD. Q2 operating margin, 23%. I think that's a historical high for you. Any special factors? That's the first question that I have.

First, starting this fiscal year or this -- yes, term. For respiratory, endoscopy that has been reclassified into TSD, moved from ESD to TSD. So that is one factor that you might want to keep in mind and Medi-Tate, I'm talking more close to the bottom line, the acquisition of Medi-Tate. And for our equity, the value was appreciated. The gain on valuation in other words, that's another factor. And another -- well, last year, the respiratory -- the bronchoscope recall expenses totaling JPY 5.9 billion was incurred and that's gone this year. And for revenue, revenue improved based on the product mix improvement. So these were the positives that contributed.

The acquisition Medi-Tate. I don't think that valuation gain was included in Q2. So on the underlying based this OP 42.3% operating margin can we assume that it is sustainable, 23% operating margin for the second half in relation to SG&A expenses? Well, let me back up. SG&A in Q2 and the revenue balance, the SG&A was relatively low whereas revenue improved. That's what happened in Q2. And the question is whether this is sustainable or not? For the second half, especially towards Q4, SG&A expenses tend to increase. And therefore, the figure -- the operating margin that we saw in Q2, I think that would be higher than for average -- and I'm sorry about my misstatement on the valuation going on Medi-Tate. And also TSD top line, the second quarter, especially in July and August because of the Delta variant.

In North America and Europe, your competitors report a rather difficult earnings whereas in your case, regarding the GI revenue quarter-on-quarter compared to Q1, 9% increase. And in almost all regions, quarter-on-quarter revenue grew. Can you give us the backdrop -- background to that on a region-by-region basis? And also in North America or in the U.S. and -- earlier this week, the TFF revision was announced and this is for next year. So I don't think there will be much impact for this year. But TFF revision, I wonder if there are any product areas - Olympus' product areas would be impacted. I think this would impact the iTind promotion, so can you talk about that in that?

Well, let me answer that first and ask Nacho to add comments later. Now competitors, what the competitions are saying, we haven't -- we don't have enough information to comment on that. So I can talk only about Olympus. For Urology, as I said in my presentation, the elective procedures, BPH and stone -- urinary stone, those are the areas in which our products are growing steadily. That's one factor. And well, things were good generally speaking, but especially for ENT endotherapy. Well, in a nutshell, number of procedures are continuing to come back. So those would be the financial analysis. Nacho, anything to add? Can you also comment on TFF?

[Nacho Abia, executive]

Yes. Let me -- well, on the question on -- regarding the recovery and the solid recovery, I think is a combination of one internal and one external factor. The external factor is the overall recovery of the procedure and also the adjustments of our customers. I think our -- the healthcare institutions have learned to operate under the COVID situation. And they are taking care of the patients by bringing the procedures back and that's definitely one factor, but we are enjoying the same trend everywhere in the market. The second factor, which is contributing to our growth is definitely the number of products that we are launching and the activity that -- the commercial activities we are developing. In other words, I think that we are increasing our portfolio, and we are increasing our market share in some areas.

So I think that if you look at the main drivers of growth, respiratory, urology and TSD and GI, obviously in urology I think that our -- the launch of the SOLTIVE lithotripsy platform has been incredibly successful all over the place, and we are gaining consistent market share in that area. We consistently keep launching new products in endotherapy and the acquisition of Veran Technologies in respiratory, it's also fueling very continuous and nice growth in that area. And obviously, in the GI side, from the ESD side, the launch of EVIS X1 is making a big factor as well. So I think it's the -- obviously, we cannot speak for our competitors, but at least in our case is the combination of these two factors what are provoking the good results and the growth that we are enjoying and the prospect -- the positive prospect that we have in the second part of the year. As to the iTind question, I was not able to capture completely the question. Can you repeat it, please?

[Chikashi Takeda, executive]

Thank you. On Tuesday of this CMS TFF schedule was announced, and I was wondering what impact it might have, if any, on your product, your business? The CMS announcement on TFF made earlier this week on Tuesday.

[Nacho Abia, executive]

Thank you. Now -- I couldn't hear the question well before. Thank you. So I think that the -- we obviously observed the TFF schedule and keep working and understanding the reimbursement scheme in the United States. I think that, in our view -- and we are in the early stage of iTind and the product just has been launched, and we are still working very heavily in training and to make sure that our physicians and our customers have learned how to utilize the product in a safely manner. I think that what we can say is that most likely, the -- we have been expecting some sort of reimbursement changes in BPH, minimum basic BPH procedures as you indicated, but we also believe that our iTind device is adding some economic value to the whole procedure, not only on the price of the device.

And I think that this is something that is going to help for further penetration and promotion of the product because it will be accepted, not only on the price of the device but also on the overall procedure, making it shorter and more efficient. So I think the -- obviously, we cannot control the reimbursement of the products. This is important for us. But obviously, is -- what is also very important is the clinical outcome in the benefit for the patient and our customers know that. So I think we have to navigate in between these two and continue supporting our customers with products that can meet the clinical need. And obviously, that are efficient and economically valuable for the P&Ls as well. Thank you.

[Chikashi Takeda, executive]

For the medium to long-term implication, I would like to ask some questions. EVIS X1, the approval schedule in the United States, is there any specifics you can talk about? The launch timing is the fiscal year ending in March 2023 first half, how about China? Do you have any concrete information you can share with us with regard to the launch in China for EVIS X1?

Yes. Regarding the FDA, you are asking about the FDA schedule for X1 in the United States? Open to the previous time -- previous meeting, we have already shared with you the basic schedule. Next year -- next fiscal year, the launch is scheduled so that is unchanged as a schedule. For China, it's yet to be determined. That's the situation actually. But just for your information, the order generation product has been launched only some time ago. So it's not so old yet. So we will continue with the product in China, which is before X1. So we've been still growing the market with that order generation in China. But China is a big market for us. So in terms of the timing of the EVIS X1 launch, if there's any more information, we would like to keep you up to date. But the evaluation process in China is very hard to predict. And so -- given that, so when we get ready we would like to share our plan with you.

Understood. Thank you. The U.S. launch schedule is first half next year -- next fiscal year, do you have a concrete schedule quarter-over-quarter or the full-fledged contribution to revenues? When is it expected? In which quarter? Do you have any view into that?

Yes, as you have correctly pointed out, in the first half next fiscal year, and that's what we are looking at at the moment.

So same timing for the sales contribution?

Of course, logically speaking, for X1 launch that is already expected for the doctors. So initial orders coming in for us or contribution starts for the P&L, that's something we are expecting as well. But Nacho is here with us. I hope that he can add some more information to this. Nacho san, could you answer the question?

[Nacho Abia, executive]

Yes, I can. Thank you, Takeda san. Yes. The answer is yes. As Takeda san mentioned is that first half next year, we are planning to launch the products in the United States. I think we need to have in mind that EVIS X1 is not one product, it's one system, and it's composed by a number of different products. And the regulatory path for all those products is not going to be the same. They're not going to be launched all at the same time. And at the same time, when we will likely launching EVIS X1 products, it will be previous generation products that still will be in the market because there are -- as I said, there's a family of products that not all will be launched at the same time. This is always the case.

Every time we launch a new generation, there is certain transition time over time. So I think to be specific with your question, what we expect is that the main products to be launched in the first half of the next year. And we expect already some contribution in next year. That will be gradually growing in next year, but also in the years to come. This is exactly the same pattern that we are seeing right now in Japan and in Europe and in Asia Pacific where we already launched the product is that steadily the EVIS X1 products are taking more portion of the GI sales in the different regions. So we are very positive about the launch of the product in the U.S. But even this year, with -- where the existing platform is already a few years old, we are seeing good development in the GI business. I think our customers know that the way we transition from one platform to the other, and they know that we are going to be with them, and we're going to work with them in order to make that transition as good as possible. So I think the pattern in the U.S. will follow other transitions we have done and gradually starting next year, we will see the positive impact of the EVIS X1 in the U.S. as we are seeing in other regions. And I hope I answered your question. Thank you.

[Chikashi Takeda, executive]

ESD business, the profit margin is what I have a question on. Q2 profit margin was very high and for the second half, historically, I think you are projecting a high profit margin. For GI, the EVIS X1 portion increasing, so how much do you expect from that? And if you are expecting contribution from EVIS X1 then I suppose there could be further upside on the profit margin for ESD. Would that be correct?

Thank you for your question. As you can see in the slide, the actual results, EVIS X1 is growing. That's one factor that contributed to better profit margin. And it's only been 6 months contribution. For the second half, the proportion of EVIS X1 contribution should go up. That's our expectation. I cannot give you specific number, but EVIS X1 portion is expected to grow, which should make further contribution to the profit. I can't give you the details for the next fiscal year, but how should I put it? There will be replacement demand. So based on that assumption, we should expect further contribution from EVIS X1 to the GI endoscopy, the ESD.

Thank you. Follow-up question, again, on operating margin. And this is not just for ESD but the SG&A expenses. In terms of controlling the SG&A expenses, I think in Q2, it was rather low -- kept low irregularly, but in the second half, SG&A expenses are not expected to grow while revenue is expected to go up. So I was wondering if they are any special factors? Still, I think you will have to expand to grow the business, to grow the top line. So the growth-oriented expense increase as well as the cost control efforts, do you think they are going to balance each other so that the SG&A expenses ratio could be kept to the current level? Do you think that rather this year was exceptional, and therefore, we should expect the SG&A ratio to go up going forward?

As for SG&A expenses, yes, within our Transform Olympus initiative. We declared in Transform Olympus that we are going to control, manage SG&A expenses and activities are ongoing, and we are beginning to see the effect of that. In particular, we call the realm of the business internally. The -- around the business, that is the expenses to continue the business. We want to control that portion. And at the same time, growth investment as well as QARA and IT expenses. The enablers and defensive portion. Those are the areas that we need to invest to protect our business. That has been the principle. And as a net result, lower the rate is what we are working on, and you see the results as you see in our earnings for Q2. We do not believe that this is the peak. We think there's still room for improvement. In terms of rate, I think we can aim for even better results. As for next fiscal year, we have yet to formulate the plan. So I have to make sure I don't overstate what is possible, but our thinking is to maintain this momentum for growth and for protection. We're not going to reduce those portions, just for the sake of reducing cost. I can't give you a more straightforward answer I'm afraid, but I think you will get the overall direction.

I would like to ask few questions. The first point is a follow-up question for the first point. For the upward revision, what is already achieved and what is to be achieved? As of the Q2, how much was the exact upside? In terms of margin, OP margin, 0.1 or 0.2. Did you -- you said that that was the upside. But as of Q2, top line was already overshot therefore, already as of the end of the first half? In terms of margin, there wasn't so much upside. But in terms of the amount, can I understand that there was a considerable upside as of the end of the first half?

I have to be consistent with the answer that I have already given. But for the first half, in the R&D expenses, there was some increase for research cost towards the end of the first half, more than expected. We may have to control the R&D cost more. And in terms of sales, as a result of the review, we decided that there was more upside. So rather than in the first half, in the second half, we are likely to spend the expenses.

Thank you very much I have a follow-up question. This time, you have incorporated JPY 12 billion Scientific Solutions Division spin-off expenses. As of Q2, it has not been actually executed. Is it going to be -- is the budget going to be executed in Q3 and Q4?

The number, JPY 12 billion is other expenses. You may have calculated the expense for that out of the total other expenses. So for the SSD reorganization expense, we are not there yet. It's not that much. But it takes up a large part of other expenses. That is true.

But for the first half, has it been already spent?

Yes, we did spend some of it in the first half, but that is not going to so much -- so significant as an amount. So most of the estimated amounts that we had in our mind will be executed in the second half.

I see. So that was not expected at the beginning of the fiscal year, so there was some unexpected expenses. However, overall, you have come up with the amount that was in line with the original expectation in terms of the OP margin.

Yes, you can say that. Thank you very much.

Now we are approaching the ending time, so we would like to close the Q&A session. With this, we would like to close Olympus Corporation's IR presentation session. Thank you very much.