Mani, Inc.TSE: 7730

Financial Results and Forecasts FY2025 2Q:Script for Financial Results Briefing

· Issued by Mani, Inc.

MANI, INC.

Briefing on Financial Results for the Second Quarter of the Fiscal Year Ending August 2025

April 11, 2025

Event Summary

[Company Name]

MANI, INC.

[Company ID]

7730-QCODE

[Event Language]

JPN

[Event Type]

Earnings Announcement

[Event Name]

Briefing on Financial Results for the Second Quarter of the Fiscal Year

Ending August 2025

[Fiscal Period]

FY2025 Q2

[Date]

April 11, 2025

[Number of Pages]

27

[Time]

10:00 - 10:43

(Total: 43 minutes, Presentation: 19 minutes, Q&A: 24 minutes)

[Venue]

Onsite venue: Sapia Tower, 1-7-12 Marunouchi, Chiyoda-ku, Tokyo, 100-

0005

Webcast: Microsoft Teams webinar

[Venue Size]

154 m2

[Participants]

Total 123 (Onsite: 37, webinar: 86)

[Number of Speakers]

2

Masaya Watanabe

Director, President and Representative

Executive Officer, CEO

Kazuo Takahashi

Director, Executive Vice President, Assistant

to the President (Special Appointive Officer),

CRO

[Analyst Names]*

Masao Yoshida

Tokai Tokyo Intelligence Laboratory

Kazue Yanagisawa

CLSA Securities

Anna Kato

Daiwa 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.

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Presentation

Moderator: It is now time, so we will begin the financial results briefing of MANI, INC. This briefing will be held in a hybrid format, with a livestreaming online session in addition to the on-site session.

First of all, I would like to introduce two people from the Company. Mr. Masaya Watanabe, President and Representative Executive Officer, CEO. Mr. Kazuo Takahashi, Executive Vice President.

Today, Mr. Watanabe, the president of the Company, will give a presentation. After the presentation, there will be time for questions and answers from the audience. Please note that we will not be accepting questions from online participants at this time. After the briefing, if you have any questions, please send an email to the IR staff in charge.

All right then, Mr. Watanabe, you may now have the floor.

Watanabe: Good morning, everyone. Thank you for taking the time off your busy schedules to attend today's presentation. I would like to begin explaining our financial results for the second quarter of fiscal year 2025.

The first issue on today's agenda is the voluntary recall of MANI DIA-BURS in China. On March 14th, upon discovery that the product registration information submitted to the Chinese regulatory authorities was incomplete, we decided to carry out the voluntary recall of the product lines affected. The recall is currently underway.

Since this issue is related to the application to the Chinese regulatory authorities, we have determined that there will be no impact on patients' health as well as sales to other regions. We are also examining the impact on our business performance for the fiscal year ending August 31, 2025, and will disclose any information that needs to be disclosed in the future. All of the rough estimates have been factored into today's explanation.

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Let me give you a more detailed overview. On October 31, 2024, we voluntarily recalled 2 lots due to the discovery that the product registration information for MANI DIA-BURS was incomplete, and therefore, we recalled the products in question.

Following this, we voluntarily stopped product shipments of all 400 items to check whether other dia-burs also had incomplete registration information. As a result, it was found that 50% of the total 400 items had incomplete product registration information. Since it was an error in the description, we have been negotiating with the regulatory authorities to correct it. However, the regulatory authorities have decided that submitting another application for change is necessary.

Rules and regulations in China require us to temporarily stop shipments and recall the affected products and only allow us to resume sales operations once the updated registration information has been approved.

Approximately 50% of MANI DIA-BURS will require changes to their product registration information, while the remaining 50% only require minor changes to the manufacturing process specifications.

MANI DIA-BURS have a market share of more than 70% in China, and our customers use our products with a very high regard for their reliability.

It pains us terribly that this error ended up having the effect of betraying the trust of our loyal customer base in China, and for this, we would like to apologize.

This also affected the approximately 200 distributors we deal with in China and it also negatively impacted the Company's stock price and, consequently, our shareholders.

Once again, allow us to express our deepest apologies.

As I mentioned earlier, we have already reapplied for regulatory approval for the product, which is expected to take about one year. During this time, we will make all the necessary preparations so that we can return to normal business operations.

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This is the biggest crisis MANI has faced since COVID, so we are committed to making sure we address this issue and minimize disruptions caused to our clients and the medical institutions that use our products.

Management at MANI is also committed to achieving the best recovery possible for the benefit of all investors and stakeholders.

To overcome this crisis, we will be enacting several changes to our business execution structure, to go into effect on May 1, 2025. One such change is to strengthen quality assurance and pharmaceutical affairs, and to this end, Chairman Saito will take on this role by concurrently serving as the Department Head of the Quality Assurance Department.

Executive Vice President Takahashi had long held the position of CFO and was in the process of passing on the baton and delegating CFO functions, but the current crisis we face necessitates his return to the site to provide solid management.

These changes will go into effect on May 1, 2025.

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I would now like to explain our financial results for the second quarter of fiscal year 2025.

As you can see here, consolidated net sales for the second quarter stood at 14.810 billion yen, which is a year- on-year increase of 6.5%, while the operating income was 4.172 billion yen, slightly below the results from the same period last fiscal year.

I will be going over the details later, but in broad terms, while the voluntary recall of dia-burs did have a negative impact of approximately 800 million yen, strong sales in the Surgical and Eyeless Needle segments nevertheless allowed us to offset this impact.

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This table details our non-operating income and expense results.

Specifically, foreign exchange gains decreased due to yen appreciation. Additionally, depreciation has now started for the Hanaoka Factory, which was completed on January 31. Consequently, we recorded depreciation expenses for the month of February under the line item of non-operating expenses. Once the Factory enters a mass production regime, depreciation expenses will then be moved to the operating portion of the income statement.

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This is the net sales status by segment.

Foreign exchange and the results for the Surgical and Eyeless Needle segments contributed to a year-on-year sales increase, while sales at MANI Dental declined by 586 million yen.

The sales decline in MANI Dental was mainly due to the negative impact of the voluntary recall of dia-burs in China totaled 800 million yen. Other than that, sales in the other remaining areas of this business were positive.

Also, within the Dental segment, we have MMG, MANI's German subsidiary and manufacturer of dental restoration materials. Sales for this business declined on a year-on-year basis. Consequently, we are aware that this is an issue and are thus in the process of executing measures toward recovery.

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Next is the net sales status by region.

Sales grew in Japan, North America, Europe, and Other regions, as the global healthcare market for the products we offer continues to grow, and as we believe that our product market is growing broadly.

In particular, sales have been booming in emerging countries such as Central and South America and Egypt.

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Next is the operating income status.

Foreign exchange, an increase in sales, and an improvement in the cost of sales ratio had a positive effect on operating income.

Conversely, the payment of performance-linked bonuses weighed down on results. As I explained during the results presentation for the first quarter, we ended up recording 230 million yen that had originally been expected for the last fiscal year, and this consequently weighed down on operating income.

Lastly, while we did record an increase in SG&A, personnel costs, R&D costs, and sales marketing costs were once again in line with the plan.

Taking all of these factors into account, operating income results were unchanged and in line with last fiscal year's results, as of the end of the second quarter.

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