Financial Results and Forecasts FY2025 3Q：Script for Financial Results Briefing

Briefing on Financial Results for the Third Quarter of the Fiscal Year Ending August 2025 July 9, 2025

(Total: 52 minutes, Presentation: 20 minutes, Q&A: 32 minutes)

Webcast: Microsoft Teams webinar

Masaya Watanabe Director, President and Representative

Executive Officer

Kazuo Takahashi Director, Executive Vice President

Masao Yoshida Tokai Tokyo Intelligence Laboratory

Anna Kato Daiwa Securities

Tomoko Yoshihara UBS Securities

*Analysts that SCRIPTS Asia was able to identify from the audio who spoke during Q&A or whose questions were read by moderator/company representatives.

To begin, I would like to introduce today's two speakers: Mr. Masaya Watanabe, President and Representative Executive Officer, and Mr. Kazuo Takahashi, Executive Vice President.

Today, Mr. Watanabe will give the briefing. Questions from the audience will be accepted after the briefing. Please note that we do not accept questions from online participants. If you have any questions, please email our IR staff later.

Now, Mr. Watanabe, please go ahead.

The first issue on today's agenda is the state of the voluntary recall of MANI DIA-BURS in China. As previously announced, we started this recall in March, and it has been progressing smoothly for four months now. We expect this recall to be completed by August.

We now have a fairly accurate idea of the scale of this recall and of its impact on Company results, which we have compiled into the table on page 2 and incorporated into the forecasts. The main point I would like to make today is therefore the fact that we have already reflected the impact of this recall on the forecasts.

The table shows the impact on sales and profit through the end of the third quarter on the left, and the full-year forecast on the right. As you can see, we are forecasting a full-year sales reduction of 1.19 billion yen from reduced new shipments, and 330 million yen from product returns due to the recall. Similarly, we expect this recall to weigh down on fiscal year 2025 profit results by 1.2 billion yen.

Compared to the initial outlook announced back in the second quarter, the volume of recalled dia-burs has increased. Based on past experience, we initially expected about 10% of the dia-burs in the market to be returned. However, we are now seeing that around 25% have come back. Regardless of the actual percentage, we want to complete this recall so we can put this incident behind us and move forward constructively.

The following graph shows the outlook for our business in China for fiscal year 2025 and our expected recovery that will follow.

As shown here, unfortunately, our revenue forecast for fiscal year 2025 has been revised downward from 8.0 billion yen to 7.7 billion yen. This 300 million yen decrease from our previous guidance is due to the increased recall volume, as I mentioned earlier. However, we view fiscal year 2025 as the bottom line, and we aim to get back on a growth track in fiscal years 2026 and 2027.

In fiscal year 2025, we will continue sales of products with no registration issues, which account for 50% of our entire product lineup, and expect approval of the amendment application for the remaining products to be approved by the Chinese regulatory authorities by March 2026.

Things are progressing slightly ahead of schedule.

The graph does not show the number forecasts for the Surgical and Eyeless Needle segments, but, as you can see, we expect strong growth in sales of these products outside of the Dental segment.

In light of these factors, we have revised our full-year forecast for fiscal year 2025. The second column on the left shows that we are now guiding for 29.6 billion yen in net sales, 7.9 billion yen in operating income, and

5.45 billion yen in net income.

If we were to exclude the negative impact from the recall of our MANI DIA-BURS, the operating income margin would be close to the previous forecast of 29.5%. Furthermore, this indicates that our other segments are performing well.

Another factor is the effects of President Trump's tariff policy. We ship products from Vietnam, and according to reports, a 20% tariff has been agreed upon. We do around 3 billion yen in business to the U.S. annually, so we can take this number and apply the tariff rate to get an estimate of the impact.

We also sell to B-to-B customers, and the relationship with our customers is currently mixed. For example, some absorb the extra tariff costs, while others stock up before the tariffs are enforced. Given this mix, different clients will have different responses to the tariffs, making it quite difficult for us to predict the impact. Currently, we estimate that around 40% will be affected, and we have factored in a ¥40 million impact.

This concludes my overview of the revised full-year forecast for fiscal year 2025.

Allow me to start with the consolidated financial results for the third quarter. As we went over just now, results were significantly impacted by the voluntary recall of dia-burs, but, conversely, the Surgical and Eyeless Needle segments delivered strong results.

We recorded a year-on-year decrease in sales and income in the Dental segment.

This table provides a breakdown from operating income down to profit before income taxes on a year-on-year performance basis. The Japanese yen has appreciated slightly, so this constituted a headwind on the foreign exchange side, and furthermore, we also recorded an increase in depreciation related to the Hanaoka Factory, which was completed in January of this year. We recorded around 120 million yen in depreciation over 4 months. If we extrapolate this figure, we expect around 360 million yen on an annual basis.

This waterfall chart shows the net sales status by segment. As you can see, sales were negatively impacted by the voluntary recall of dia-burs and weak sales from MMG; however, sales by other segments have posted a year-on-year sales increase. I will explain the details of MMG's sales later on.

In this context, you can see that the regions of Russia and India are growing, especially in MANI Dental.

Net sales grew globally across the board, with the sole significant exception being China. Sales growth from products in the Eyeless Needle and Dental segments was particularly pronounced in Central and South America, Russia, and Egypt.

We significantly enhanced sales and marketing efforts in collaboration with dental distributors in Japan, and these efforts have borne fruit in the form of sales growth in this market, as well.

As for the Americas, sales were down in North America but higher in Central and South America. This is partly the result of our eyeless needle clients moving their factories from the U.S. to Central America, so, in reality, we have been able to grow sales in North America.

This next waterfall chart shows the operating income status. Operating income is down due to temporary factors like the voluntary recall of dia-burs in China and performance-linked bonuses from the previous fiscal year. As we've mentioned on previous occasions, bonus provisions for the previous fiscal year ended up being paid a lag, so this, together with the impact of the recalls, ended up having a temporary, non-recurring impact of approximately 1.2 billion yen.

Excluding these impacts, sales were up, and the cost of sales improved, while, conversely, SG&A expenses increased. All in all, these results were more or less in line with Company forecasts.

Next are the financial results by segment. Net sales were up 16% in the Surgical segment, up 6% in the Eyeless Needle segment, and down 10% in the Dental segment.

Allow me to go over the results for each segment in more detail, starting with the Surgical segment. Ophthalmic knives drove sales growth in the Surgical segment, where sales increased globally across the board, particularly in Europe, Asia, China, and Japan.

In addition, profitability improved due to price optimization and cost reduction, which has pushed back the increase in SG&A expenses and led to growth in operating income.

Our priority measures for the future are as follows. Firstly, we will continue to strengthen our sales and marketing activities around the world. Secondly, we will actively promote the strategic alliance that we have formed with MST, Microsurgical Technology in the U.S. Thirdly, in Europe and Asia, we already have high market shares in certain regions, so we will aim to expand these leading models in other regions.

The Eyeless Needle segment recorded a year-on-year sales growth of 6%, slightly exceeding the overall market growth, as we secured more market share. In China, we are promoting strategic partnerships with JINHUAN, and we are providing needles to suture manufacturers under the GPO, which also stands for VBP (Volume-Based Purchasing) and pertains to collective buying power purchases by the Chinese government. Under this initiative, we benefit from tailwinds from China's preferential treatment of companies that manufacture products within its borders. Gross profit margin improved, but operating income margin declined slightly due to increased SG&A expenses.

Our priority measures for the future are as follows. Firstly, we will expand sales by taking advantage of our special needles' product superiority, for example, our micro-surgery needles and black needles. Secondly, we will enhance our efforts to counter emerging market competitors, with a particular focus on refining account strategies. Thirdly, we would also like to work on catching up in terms of manufacturing costs.

As for the Dental segment, while the results were affected by the voluntary recall of dia-burs, excluding this impact, we recorded 15% year-on-year growth.

Our German subsidiary MMG, unfortunately, ended up unprofitable and is an issue for us. This business needs a results turnaround, and we are carrying out structural transformation efforts to this end.

Specifically, MMG has three major customers, and a decline in orders from these customers was a significant negative factor. Against this backdrop, we are working to deepen engagement with tier 2 customers and carry out cost reform initiatives.

As for JIZAI, annual shipments have reached 280,000 units, marking a 66% increase on a year-on-year basis, but our market share is still small, so we will continue to strengthen our efforts on this front. We are also developing JIZAI-2, which we expect to be able to bring to market next fiscal year.

Lastly, in the U.S., we will respond to large-scale inquiries in the country.

Next is the balance sheet. In terms of the key topics here, we invested in the construction of the Hanaoka Factory, which is now complete, and we are currently installing the necessary equipment. This has led to a decrease in cash and deposits, while non-current assets increased.

While inventories remained more or less flat at 6.3 billion yen, sales have gone up, meaning a reduction of 4 holding days. In other words, we are seeing the results of our transformation efforts at the supply chain management level.

Next, I would like to introduce two key topics.

The first key topic is the business progress in the North American market.

We position business expansion in North America as a key initiative for MANI. As previously announced, we established a local subsidiary in the U.S. in September last year, called MANI MEDICAL AMERICA, INC.

We then entered a strategic partnership with MicroSurgical Technology in April of this year. We also hired a local manager with extensive industry experience, who has helped us make significant progress in strengthening our sales structure in the Surgical segment.

In light of these various initiatives, we position expanding our business presence in the U.S. as a key strategic investment theme. Specifically, we will work to increase our ophthalmic knife market share in the country from 10% to 30%. Additionally, as we develop a closer relationship with customers, the dynamic shifts away from the mere sale of medical devices and toward touchpoints with KOL doctors.

As such, we want to leverage this to build a business in the U.S. based on a customer-centric approach. The Surgical device market in the U.S. centers primarily around pre-packaged kits. In particular, top industry players like Alcon have phacoemulsification machines, and their business revolves around disposable consumable components for these machines. This is a business model very particular to the U.S., and we are currently carrying out efforts to enter this business.

In this context, our alliance with MST is therefore very valuable, and both MANI and MST are now discussing and planning the best ways to offer each other's products on a global scale.

Then, we will be launching new products in the domain of ophthalmology, like vitreous forceps and hooks, allowing us to grow our device lineup and expand into a broader business domain.

As for measures to cope with President Trump's tariff policy, although we do not have a perfect solution, one of our countermeasures is to promote changes in the commercial distribution channels. We have been selling

directly from our factory in Vietnam to our customers, but going forward, we will shift to selling through MANI MEDICAL AMERICA, INC.

Additionally, we will engage in detailed and careful negotiations with B-to-B customers as it pertains to these tariffs. We have over 10 client accounts in the Eyeless Needle segment in the U.S., so we will work to create new opportunities by deepening relationships with these clients.

The sales trend is shown in the upper right, and the forecast for fiscal year 2025 is slightly above 2.8 billion yen. Earlier, I mentioned the impact on Eyeless Needle segment sales of our U.S. customers relocating their factories to Central America, and, going forward, we intend to grow sales to the U.S.

The second key topic is the start of PPA (Power Purchase Agreement) services at the Hanaoka Factory. This initiative involves the installation of a solar power system in collaboration with TOCHIGI BANK, LTD., and we have now begun operations using this system.

Lastly, during MANI's results presentation in January, we said we would be releasing the next Medium-Term Management Plan at some point between July and September, but we have now decided on October 8, 2025 as the date, which is the scheduled date for the full-year earnings announcement for fiscal year 2025.

This concludes today's presentation.

A full transcript of this presentation, including the Q&A session, will be made available at a later date. If you wish to remain anonymous, please do not give your name when asking a question.

If you have any questions, please raise your hand.

I have two questions. First, I would like to ask more about the impact of tariffs. Looking ahead to the next fiscal year, this year's impact was 40 million yen, and I believe that was only for the fourth quarter. Is it reasonable to think of it as something like multiplying this number by four for the full-year estimate?

From what you mentioned earlier, I understand that some customers are willing to absorb the cost, while others are not. In the U.S., I believe many eyeless needle customers have a high sales ratio and profitability, so I wonder if the situation differs by segment. Could you please help clarify the expected impact of tariffs for the next fiscal year?

Many of our customers, particularly for eyeless needles, are B-to-B customers, mostly large companies. Since the cost of eyeless needles account for a very small portion of the total cost of suture products, many of these customers have agreed to absorb the tariff increase.

As for ophthalmic knives and dental products, we expect that the increased tariff burden will be shared reasonably between us and our distributors through negotiations.

At this point, we estimate that about 40% of the total sales base will be affected. However, this is subject to change depending on future tariff developments and negotiations with customers, making it difficult to make a precise forecast. That said, we have incorporated this view into our figures for the fourth quarter.

However, if we look at the following year, the growth rate will be about 14%. Looking at the outlook for the Dental segment, the shift from stainless steel files to nickel-titanium files is progressing, and considering the possibility of centralized procurement of ophthalmic knives in China, I feel that the market assumptions may be changing from previous patterns.

Given that sales were lowered this fiscal year, how confident are you that the Chinese market will recover firmly in the next and following fiscal years? If you have any thoughts on this at the moment, I'd appreciate it if you could share them.

Since we have some time before the relaunch, we are working to improve product quality. Currently, we have around 100 distributors, but we are also pushing to expand access to nearly 200 stores.

Therefore, we will take measures both in terms of products and sales. Although it may be difficult to immediately return to a 70% share within the following year, we hope to restore it over the next three years or so.

As for the sales outlook in China, revenue has declined to 7.7 billion yen, but we are looking at a growth rate of about 11%. Looking at past performance, growth in local currency terms has been about 14%, so we expect a slight slowdown. Since we already hold a very high market share, the room for further growth is naturally narrowing.

To drive sales under these conditions, we are now considering launching new products. Additionally, we will obtain regulatory approval for JIZAI in China and plan to begin sales next year. We see this as a key offensive strategy.

Also, regarding the dental hand files, when I explained the situation in April, I may have conveyed a somewhat negative tone and given a misleading explanation. In reality, we do not expect a decline in sales or market share; rather, we anticipate flat or slightly positive growth, albeit at a very modest rate.

Especially on the sales front, about 10% of our SKUs are products designed to be used alongside nickel-titanium files. These items are highly distinctive as MANI products and are widely adopted. Therefore, we do not view hand files as being entirely negative in terms of performance or market potential.

Surgical ophthalmic knives have not been subject to centralized procurement so far. However, based on trends observed in other product categories, items tend to become targets for centralized procurement once domestic Chinese manufacturers reach a certain level of market share. In the ophthalmic knife market, our company currently holds over 50% market share, meaning that domestic competitors have not yet gained significant ground.

That said, we must not let our guard down, so we are now actively preparing for the possibility of centralized procurement and are currently considering establishing a manufacturing facility in China.

In particular, since we will have a production line placed in the Smart Factory, we will roll it out in China, especially by taking the downstream processes there.

First of all, as you commented on the selling price in your presentation, I believe that you have been aware of the issue of the price of your products being a little low compared to other companies' products in the past, despite their high quality. Since you mentioned that you are working on the price revisions, I wondered if progress had been made in this area based on the results of this quarter. Looking at your catalogue, some products in Japan have increased prices by around 10%.

If this is being implemented globally, I would expect to see more tangible effects. Could you share your thoughts on this? Has the initiative been carried out during the third quarter, and is there still room for further improvement? Given that the full-year earnings forecast has been revised and we are already in the fourth quarter, has the price improvement already been fully executed? I would appreciate it if you could answer this first question.

Therefore, rather than just in the fourth quarter, we will continue to view strategic pricing as an ongoing management priority heading into the next fiscal year as well.

As for MANI's price positioning, as you rightly pointed out, our prices are generally not high despite the excellent quality of our products, which I also find unfortunate. For example, our ophthalmic knife is sharper than our competitors' knives, yet our prices are about 10% lower in terms of street pricing.

Another point is the significant variation in pricing across regions. In negotiating selling prices, ophthalmic knives are very strong products, so negotiations can be successfully concluded. In the case of eyeless needles, since our customers are suture manufacturers, the cost of our needles represents only a small portion of their overall product cost, which makes negotiations relatively smooth. On the other hand, the Dental segment is a somewhat competitive, and we are having some difficulty.

In summary, while ups and downs depend on the product and region, we are committed to pursuing strategic pricing across the board.

Although there are challenges related to the product mix, overall, the gross profit margin is trending toward improvement. However, SG&A expenses have been rising significantly, which is offsetting some of the gains.

cases. Our ophthalmic knives are typically used in standard cataract surgeries and are part of the daily surgical toolkit for physicians. In contrast, MST's products are mainly designed for more challenging cases.

Regarding MST's market share, it varies by region, some areas show around 5% or 10%, while others reach approximately 70%. We are aiming to expand the sales of our ophthalmic knives to MST's customer base. Currently, our market share for ophthalmic knives in North America is about 10%, and we are targeting an increase to 30%. We estimate that our partnership with MST could contribute roughly 5-10% toward that goal.

Sales to MST have already begun, albeit in small volumes, but we plan to accelerate efforts moving forward. Therefore, we expect the impact to start appearing relatively soon.

In comparison with that previous announcement, could you share any positive and negative aspects we should be aware of? I understand that the voluntary recall has started in March 2025, but since you had already been in discussions with the Chinese authorities prior to the announcement made in January 2025, it's difficult for external observers to understand what assumptions may have changed. So, I would like to know about the positive and negative aspects, comparing your position now with the previous one.

While we stated that we will achieve the 30 billion yen target in the medium-term management plan, the actual figure will be 29.6 billion yen, so we hope you'll allow us to round off the amount to a larger amount. That said, we believe the strategic focus is shifting in a qualitative sense, and we see this as a graduation from the previous five-year medium-term management plan after four years, not a dropout, but a graduation. Looking ahead, we aim to launch a new four-year medium-term management plan targeting 50 billion yen in net sales and a 30% operating income margin, as previously mentioned.

Therefore, in the upcoming announcement in October, we plan to present concrete measures toward that goal. In particular, we received many questions previously regarding cash allocation, and we intend to provide clear answers on that point.

In terms of introducing specific growth drivers, we are considering further investments in sales channels and other areas. At the same time, we recognize the need to respond to environmental changes and defensive measures.

In terms of bringing in specific growth drivers, we are considering further investments in sales channels and other areas. On the other hand, we recognize the need to respond to environmental changes and defensive

measures, such as the impact of Trump tariffs, the competition with emerging countries, and China's GPO (Group Purchasing Organization) system. As these changes unfold, we are working to respond appropriately while continuing to grow in areas where we see potential. This is the framework we are currently organizing and refining.

The first question is regarding the downward revision of the full year forecast this time, but if I recall correctly, during the second quarter earnings briefing, the stance was that even considering the impact of the voluntary recall in China, there would be no need to revise the forecast downward. While I understand that the number of units subject to recall has since increased, are there any other changes in outlook compared to the second quarter, not only limited to the dental segment in China? If so, could you please share those differences?

Additionally, although the recall had a negative effect, we aimed to recover from it by exceeding our sales targets and improving costs, both of which would be necessary to offset the impact.

As explained today, our Surgical and Eyeless Needle segments grew by 16% and 6% year-on-year, respectively. However, in the previous year, those growth rates were even stronger at 25% and 12%. Therefore, we ambitiously want to maintain such momentum, and when we look at the total balance, we have announced that we will keep the full-year forecast unchanged as of the second quarter.

The current product lineup forms a complete set. The concept behind JIZAI-1 was to offer high flexibility, making it particularly effective for treating curved root canals. Compared to the nickel-titanium file lineup offered by our top competitor, Dentsply Sirona, our device provides superior flexibility. Additionally, JIZAI-1 was introduced with the added feature of being highly resistant to breakage.

The upcoming JIZAI-2 is designed to treat a wider variety of root canal shapes, including straight and slightly curved canals, and will be expanded into a lineup that can be used more broadly across different cases.

Currently, the JIZAI series includes three products, and we are planning to increase it up to about 10 products. Our strength lies in the trade-off between cutting efficiency and flexibility, and with JIZAI-2, we aim to deliver a product that offers excellent usability and that is unique to MANI for dentists.

I understand that the revision was unavoidable due to the unsettled situation. However, for example, SG&A expenses were revised upward slightly by 100 million yen in this announcement, and I wonder if there was some room to control this increase. Was it a deliberate decision not to cut back as you implement strategic investments?

Also, considering the recent changes in management, I would very much like to hear the President's thoughts on the Company plan again.

I understand that your question is about whether there was an option to control SG&A expenses a little more and make a profit, but when you look at the overall balance, MANI has operated for many years as a relatively small-scale company, and there are areas where our management infrastructure remains underdeveloped. We made a strategic decision that these reinforcements cannot be postponed any longer.

If the Chinese market were to grow slower than it has in the past, it might be a little more difficult for dia-burs to recover market share. Please tell us whether risks, such as difficulties in regaining market share for dia-burs, or customers shifting toward cheaper local alternatives.

However, in our specific field, such as root canal treatment, the impact is relatively limited, even though there is still an impact. That is why we are factoring in a slight slowdown in China's growth rate, which has been growing at about 14% in the past, to maybe 11%.

To maintain growth, we will keep launching new products in China. We plan to launch JIZAI next year, and beyond that, we intend to strengthen our dental product lineup through various means, including in-house development and strategic alliances.

Could you please share what kind of results or progress have been achieved so far from the President's point of view?

Also, I have noticed that there have been some additional changes recently, and they seem to have occurred within a relatively short period of time. If possible, I'd appreciate it if you could explain the background behind these decisions.

I think your concern is that there might be a potential mismatch between the employees and the Company, but the results of our employee engagement survey were very positive. The new management structure, managers, and regular employees are engaged in a variety of activities, and I am aware that they are moving in a relatively smooth and positive direction.

As for your question about the new CFO starting in September, as noted here, Mr. Takahashi is retiring, and in the process of searching for a successor, we've invited Mr. Yamamoto to join us from Toshiba.

Document Notes

1. Portions of the document where the audio is unclear are marked with [inaudible].

2. Portions of the document where the audio is obscured by technical difficulty are marked with [TD].

3. Speaker speech is classified based on whether it [Q] asks a question to the Company, [A] provides an answer from the Company, or [M] neither asks nor answers a question.

4. This document has been translated by SCRIPTS Asia.

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