Astellas Pharma Inc. (TYO:4503)
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Sustainable Meeting 2024

Feb 21, 2025

Summary

The meeting detailed how sustainability initiatives, such as organizational health and social impact programs, are linked to enterprise value through innovation, talent development, and governance. Quantitative analysis showed that diversity and governance metrics correlate with market cap, while leadership addressed engagement and transformation challenges.

Hiromitsu Ikeda
Chief Communications and Investor Relations Officer, Astellas Pharma

Thank you very much for your joining with us for this Astellas Sustainability Meeting 2024, despite your busy schedule. I would like to serve as the moderator for today. I'm Ikeda, chief communications and IR officer. Today, after an explanation for our company, we will move on to the Q&A session. The presentation will be given in accordance with the presentation materials posted on our website. Simultaneous interpretation will be provided between Japanese and English, including Q&A session. Please note that we cannot guarantee the accuracy of the simultaneous translation. The language can be selected from the menu on the Zoom webinar screen. The material of our presentation, answers, and the statement by representatives for the company in the Q&A session includes forward-looking statements based on assumptions and beliefs in light of the information currently available to management and subject to significant risks and uncertainties.

Actual financial results may differ materially, depending on a number of factors. They contain information on pharmaceuticals, including compounds under development, but this information does not intend to make any representations or advertisements regarding the efficacy or effectiveness. Now, I would like to introduce you to the participants for today. The president and CEO, Naoki Okamura. Head of sustainability, Shingo Iino. Takashi Tanaka, outside director, chair of the nomination committee, chair of the compensation committee. Mika Nakayama, outside director, chair of the audit and supervisory committee. The executive vice president, chief people officer, and chief ethics and compliance officer, Katsuyoshi Sugita, is not available here today. So when it comes to his part of the presentation, a pre-recorded presentation will be given. So now, Okamura [Non-English content], please start the explanation. The floor is yours.

Naoki Okamura
President and CEO, Astellas Pharma

Hello, everyone. I am Okamura from Astellas Pharma Inc. Thank you very much for joining in this sustainability meeting despite your busy schedule. This is a cautionary statement for today's presentation. I will skip this reading since Ikeda explained it earlier. In the past three meetings, we have explained the progress of sustainability initiatives and their outcomes. In this fourth meeting, we will focus on the relationship between sustainability initiatives and enterprise value enhancement. Before we get into the main topic, I would like to explain Astellas' definition of sustainability and where sustainability initiatives are positioned in our daily activities.

Page four. I will first explain Astellas' definition of sustainability. As a member of society, we will naturally continue to address important sustainability issues, such as climate change. On the other hand, since we are in a life science industry, the essence of our sustainability is to contribute to society through our core business.

Astellas' efforts will increase the trust of our stakeholders, which in turn will make Astellas more sustainable as a company, thereby creating a positive cycle that improves the sustainability of society. Creating such a positive cycle is what sustainability means to us. Through today's presentation, I hope to convey how Astellas' initiatives have an impact on society and contribute to improving its sustainability, as well as how they have an impact on improving our corporate value. Page five. This is a logic tree for enhancing enterprise value. This logic tree visualizes how Astellas' financial and non-financial initiatives lead to improvements in corporate value. It was created in response to the needs of investors, who wanted to see the relationship of these between Astellas' initiative and the improvement of corporate value, and was disclosed in the integrated report in October 2024. We have presented it today for your review once again.

Today, of this logic tree, Sugita, CPO , and CECO will explain the blue part. Iino, Head of Sustainability, will explain the yellow part, and Tanaka, an Outside Director, will explain the green part. Specifically, Sugita will explain examples of innovations and results generated from the Organizational Health Goals. Iino will explain the social impact of efforts related to the analysis of the relationship between human capital and governance enhancement and corporate value improvement, as well as initiatives of collaboration and support for the health system enhancement. Tanaka [Non-English content] will provide an update on the corporate governance in FY 2024 in relation to governance enhancement. Slide six is today's agenda. Please note that Sugita's part is a pre-recorded presentation, as has been explained. Thank you for your understanding. Now, please watch Sugita's presentation, pre-recorded one first.

Katsuyoshi Sugita
EVP, Chief People Officer, and Chief Ethics and Compliance Officer, Astellas Pharma

Hello, everyone. I am Sugita, CPO and CECO. I would like to explain about the innovation cases and the results that came out of OHG, or the Organizational Health Goals. Page eight. When Astellas formulated the CSP 2021, we had deep and thorough discussions to realize the vision. We examined the specific issues that were hindering innovation and concluded that the most important issue was to reform our organizational culture. Based on this issue, we developed OHG, or Organizational Health Goals, and have been working to achieve them. The OHG has three key areas of focus: innovation, talent and leadership, and One Astellas. Today, I would like to present three examples of the business impact of our efforts to achieve the OHG, creating innovation, talent acquisition, and development based on corporate strategy, and unleashing talent potential and retention. Slide nine.

To begin with, I will describe simultaneous global regulatory submissions of VYLOY as an example of how our efforts to achieve OHG, or Organizational Health Goals, have had a tangible effect on business innovation. Although it is difficult to compare head to head due to the different types of the data used in the submissions, in case of the global product in the past, it took more than two years from the initial submissions to complete them in multiple regions. Despite such circumstances, we set a bold and ambitious goal of submitting more than 10 BLAs, or Biologic License Applications, in 12 months. To achieve this goal, we identified potential risks, developed countermeasures, and engaged in appropriate and intelligent risk-taking. For example, potential risk of simultaneous submission is handling inquiries from multiple regions at the same time, which is difficult with the current resource level.

We created efficient resource planning and a reproducible core BLA dossier structure for the first submission so that we could easily adapt them. This requires close collaboration within and across divisions as One Astellas. Instead of hand off to the next department after one step was completed, each division began working side by side at an earlier stage to accelerate the handoff. As a result, 13 submissions were completed in FY 2023, which is significant. Of these, four major regions of the U.S., Japan, Europe, and China, submissions were completed in three months, and this is unprecedented achievement. As of the third quarter of FY 2024, we had received approval in 30 countries and launched in nine countries.

It is difficult to say our contribution factors of this in a word, but we believe one of the reasons is that we've already implemented our OHG 1, brave ideas pursue ambitious outcomes, and the OHG 3, we excel as One Astellas internally. Slide 10. Second is about talent acquisition and development based on corporate strategy. In order to develop talent based on corporate strategies, we have started the development of next-generation leaders who will take on actual management issues. Astellas hires at the earliest possible stage, for example, at the senior director level rather than the division head level, all of a sudden, and promotes talent to move senior positions while developing them internally. As part of this process, we now have a Next Generation Leadership Program. We select 50 high-potential global leaders and conduct trainings for them.

The training is characterized by its practical content that can have a direct impact on business rather than classroom trainings. The group will spend six months working on solutions to eight real difficult business issues that Astellas faces. Finally, all 50 participants meet face-to-face and present their proposals to CXO and senior leaders, and approved proposals will get into the business project phase. This time, four proposals were approved, and these four are now in the process of consideration as projects. In this way, the Next Generation Leadership Program not only develops talent but also brings together the wisdom of the high-potential leaders to be immediately applied to business growth. This is one example of how we are promoting the talent and the leadership threads, which is Organizational Health Goals, OHG 2. Page 11.

Lastly, but not least, talent potential and the retention challenges in number is explained. Astellas uses the global engagement survey score as an indicator of the progress of our OHG, Organizational Health Goals initiatives. To date, key scores have steadily improved, although it's just one to two points each year. However, this year's engagement score is 69. While we have been moving quickly to implement major organizational and institutional changes, we have not taken sufficient steps to deepen employees' understanding. As a result, continued improvement in engagement scores is rather resulted in a two-point decrease this time compared to FY 2023. We take these results seriously, share them openly and widely internally, and take an action to improve it.

As we continue to reform, we have identified the issue of communication, such as properly conveying the thoughts of top management and senior leaders to frontline employees when there are numerous changes. The score for change communication, a new item in the survey this time, is the lowest in all. In order to address the areas that need improvement specifically, a task force team has been formed with members from HR, digital, and communications divisions. That team is now already working on solutions. Currently, we are planning to provide a management education focusing on change management, including trainings for leaders and managers close to the front lines to strengthen their communication skills. We believe that increasing employee engagement is very important to realize the full potential of our talent and to retain them. This is the last page of my part.

So far, I have explained the impact on business of efforts to achieve Organizational Health Goal in three areas: creating innovation, talent acquisition and development based on corporate strategy, and unleashing talent potential and retention. Our talent strategy does not exist apart from the corporate strategy. Talent strategies are part of our corporate strategies, and we are working to ensure an impact of them on our business. Fostering organizational culture is difficult to achieve in the short term and requires a long-term perspective. But as I explained today, there have been many cases where the mindset of OHG, Organizational Health Goal, has taken root among employees, been put into practice, resulting in an impact on the business. Not all of them have been successful. As I explained in the engagement score, there are some areas that need more improvement, which we believe that we have shared openly.

We would like to continuously contribute to realize the vision while implementing measures to address areas that need improvement.

Hiromitsu Ikeda
Chief Communications and Investor Relations Officer, Astellas Pharma

The sustainability part. Iino-san, our head of sustainability, will explain. Please start.

Shingo Iino
Head of Sustainability, Astellas Pharma

Hello, everyone. I am Iino, head of sustainability. I would like to explain two efforts to improve sustainability. The first is visualizing the social impact of access to health initiatives. Specifically, I will introduce a case study of quantifying the social impact of a disease awareness program in Malaysia. The second is impact of non-financial activities on enterprise value. I will explain the results of our study on the relationship between our non-financial activities and market capitalization, which we consider important as our enterprise value. Page 14. First, let me explain the first point, quantification of social impact.

As has been explained in the past, we are engaged in a variety of activities to improve access to healthcare on a global scale. We believe that we are making a social impact through these activities but have not been able to visualize them. This year, we addressed this issue. One of the programs that support activities to strengthen healthcare systems and improve health literacy in countries and regions with fragile access to the BEAUTY & Health Program in Malaysia. Focusing on this, we have converted the social impact of the activity into a monetary value. This illustrates the social impact of this activity. In Malaysia, more than 60% of cancer patients are diagnosed at an advanced stage. Due to the low awareness of cancer disease and cultural backgrounds, the cancer screening uptake rate is low, which is one of the social issues.

Two NGOs, the National Cancer Society of Malaysia, NCSM, and the Asia Cancer Forum, ACF, have been working to address this issue through the BEAUTY & Health Program, a cancer awareness program. Astellas supports the BEAUTY & Health Program by donating about $1 million. The BEAUTY & Health Program raises awareness of cancer disease and promotes screening in local communities in Malaysia. The program is expected to improve the prognosis of cancer through early detection and treatment as an outcome. The social impact of these activities has been discussed qualitatively but has not been easily quantified. We categorize the social impact into five values and converted three of them applicable to this activity, namely medical value, psychological value, and economic value, into monetary values.

There are various methods for the conversion, but the conversion of efforts to improve access to healthcare into monetary values is a very challenging task, as there are few prior studies that can serve as a reference. The following is the results of our calculations. The BEAUTY & Health Program conducts disease awareness activities targeting five cancer types as described at the footnotes. For this conversion, we calculated only colorectal cancer, which has the highest incidence rate in Malaysia and usable published data. Please turn to the next page. Page 15 shows the results of monetary valuation of the social impact by the BEAUTY & Health Program. There are several assumptions. As is described at the very bottom of this page, the BEAUTY & Health Program's education and literacy initiative related to cancer reached 1 million Malaysian residents.

As a result, 450 colorectal cancer patients were diagnosed and treated early, and the impact was calculated based on a reduction in the number of cancer patients detected in stages three and four, from 75%-55%. These were our assumptions. According to monetary valuation under these assumptions, a social impact of $4.6 million, or JPY 680 million, is estimated to be generated, as is shown as the total in the right bottom. Compared to our input of $1 million, or JPY 150 million, shown on the previous page, a simple calculation leads to ROI of 4.6 x. If you look at the breakdown of the generated social impact by areas of impact described vertically on this page, the medical value accounts for the biggest portion of 61.4% with $2.8 million, followed by psychological value of $1.3 million, accounting for 29.1%. Economic value was relatively small.

Economic value with income impact accounted for 7.9% with $400,000. Economic value with expenditure impact was 1.6% with $75,000. By target benefiting from impact shown horizontally, the so-called primary impact or direct medical impact on patients was the biggest with $2.8 million, accounting for 60.7%, followed by secondary impact or indirect impact on patients, which accounted for 36.3% with $1.7 million. This indirect impact on patients includes patients' work productivity improvement and treatment-related cost reduction. We found that there is a certain level of impact also on families and medical institutions.

As tertiary impact, as well as on social security and the whole industry as quaternary impact. This time, these were the results focusing on colorectal cancer only, not only including direct medical impact on patients, which is drawing attention in general so far, but also including secondary impacts such as patients' work productivity improvement, as well as value for families and society. We believe that we were able to specifically and quantitatively show the possibility that social value of $4.6 million could be generated. There's also some limitation, as we could not perform monetary evaluation of medical value and psychological value of quaternary impact. We believe these are the challenges we need to address in the future. Page 16. I will explain the second theme. We at Astellas implement a variety of non-financial activities.

All of these are important initiatives for a company. It was not so clear how they are impacting our enterprise value. Also, some of the stakeholders are wondering how much Astellas' non-financial ESG initiatives are linked to the enhancement of our enterprise value. This time, among our non-financial initiatives, we focused on human resources and organization and corporate governance strengthening to analyze how much various activities related to those are relevant to market capitalization, which we regard as important as our enterprise value. In order to ensure the accuracy of the analysis, in addition to our data, we also used published data of about 1,700 companies listed on the Tokyo Stock Exchange's prime market. As for analysis items, we used market cap as objective variable and human capital indicators and corporate governance indicators as exploratory variables.

We performed the analysis with four analysis methods, namely correlation analysis, simulation analysis, contribution analysis, and causal inference. We thought that by combining these four methods, we can obtain more robust results in our analysis. We also believe that these are highly unique analysis methods, leveraging analytical capabilities of Astellas, which is creating innovative healthcare solutions in its core business. We named this approach the Astellas Model. These analysis results suggested connection between market capitalization and the following indicators. Four human capital indicators, namely percentage of female managers, ratio of managers, employee job satisfaction, and employee evaluation of corporate management, and two corporate governance indicators, average remuneration paid to directors and the number and ratio of outside directors. Today, out of these analysis results, I will explain the representative results on the following two pages. Next page, please. Page 17.

The graph on the left shows the results of simulation analysis regarding the percentage of female managers. Based on the data of 1,700 companies listed on the Tokyo Stock Exchange's prime market, we used a machine learning model to analyze the relationship between the percentage of female managers and market cap. Specifically, using our actual data from 2023 as a reference, we performed a simulation to see what kind of impact there can be on market cap when the percentage of female managers alone is changed from 1% - 60%. The results suggested that market cap rises when the percentage of female managers is between 25% and 40%. The graph on the right shows the analysis results of the contribution of financial and non-financial indicators to market cap. In contribution analysis, it's important to more accurately measure the contribution of each indicator to market cap.

In order to avoid overestimation of contribution, we added financial and environmental indicators to the analysis. The level of each factor's impact identified in the contribution analysis is shown here in a descending order, with more impactful ones from the top. The impact of each factor was calculated by numerical values called SHAP values. I'm going to skip the details, but SHAP values indicate how much each factor raised or lowered the forecasted results from the average. The horizontal axis in the graph corresponds to the SHAP values. We looked at how much contribution the percentage of female managers would demonstrate. Analysis results suggested after financial indicators such as net profit, total equity, operating cash flow, average trade volume, and gross margin rate, the percentage of female managers, which is a non-financial indicator shown in the red box, is contributing to market cap.

As for color coding in the graph, we are showing the numerical value of each indicator in the red and blue gradation. Specifically, if the indicator is closer to the maximum value, it's shown in red. If closer to the minimum, it's shown in blue. For example, if you look at the percentage of female managers, companies with a higher percentage, shown in red, are positioned on the right side of the graph, and we can see the positive impact on their market cap. On the other hand, companies with a lower percentage, shown in blue, tend to have a smaller impact. This result supports the simulation analysis results, where the percentage of female managers have a big contribution to market cap, and when it exceeds a certain level, impact will emerge. Next, on page 18, I will explain the analysis results of causal inference.

Causal inference is not the mere correlation analysis; rather, it's about the causal relationship between causes and results. When input is changed, output changes accordingly. For example, in a causal analysis, in order to estimate the causal effect of each indicator as accurately as possible, analysis is performed by focusing on the exclusion of the impact of other factors. In the analysis, the panel data was utilized where financial and non-financial indicators of companies listed on the Tokyo Stock Exchange's prime market were tracked for 11 years. Upon estimation of causal relationship, there was a need to take into account individual characteristics of each company, in addition to factors that change over time. Therefore, we used a method called fixed effects model. We excluded the impact of each company's characteristics in addition to financial indicators, Then evaluated the impact of non-financial indicators, respectively.

In this graph, please focus on the ratio of managers. In this analysis, a 1% increase in the ratio of managers leads to a 0.33% decrease in market cap, equivalent to about JPY 9.24 billion in the following year, according to the results. Regarding the increase or decrease of the ratio of managers, flattening of the organization is a corresponding initiative on Astellas human resources and organization. At Astellas, we reduced the number of layers from CEO to flatten the organization. By doing so, we are promoting faster decision-making and fostering an environment that generates innovation. Specifically, as is shown in the diagram on the right, this is what we call span of control, an initiative to secure at least a certain number of members each people manager manages. Analysis results from causal inference showed that an increase in the ratio of managers has a negative impact on market cap.

We are hoping that our initiatives to flatten our organization will work positively on market cap in the end by promoting organizational health and further driving our business activities. Next page, please. Page 19 shows indicators suggested to be related to market cap according to the data analysis results, which are also initiatives strengthened at Astellas. The upward arrow means that an increase in that specific indicator has a positive correlation with market cap, while the downward arrow means that an increase in that specific indicator has a negative correlation with market cap. Analysis results suggested the connection between the following indicators and market cap. They are four human capital indicators, namely, the percentage of female managers, the ratio of managers, employee job satisfaction, and employee evaluation of corporate management, and two corporate governance indicators of average remuneration paid to directors and the number ratio of outside directors.

Using the four analyses unique to Astellas, we were able to obtain more robust new insights. We were able to identify items which could potentially impact market cap among our initiatives and items specified in the guidelines, which we think was a great achievement. Lastly, I'd like to touch on limitation. There is a limitation to the number of data we have and the number of data disclosed by companies listed on the Tokyo Stock Exchange's prime market, so we think it's difficult to use these analysis results alone as absolute data in developing our future strategies. Enrichment of disclosed data accumulation, and continuous analysis, et cetera, will enable more robust analysis. Through various analysis, we'd like to analyze non-financial activities which could impact our enterprise value going forward as well. Next, page 20. This is my last page.

Let me summarize the results of the two initiatives I explained today in association with the logic tree. First, I explained the results of monetary evaluation of the BEAUTY & Health Program in Malaysia, one of the initiatives for strengthening health systems. We quantified the social impact, which could not be visualized before, and it was suggested that social value of $4.6 million could be generated from an input of $1 million. Secondly, in our initiatives for human resources and organization and initiatives for strengthening corporate governance among Astellas non-financial activities, we identified initiatives with connection with market cap, which represents our enterprise value. Analysis results using four models unique to Astellas suggested that four human capital indicators and two corporate governance indicators have connection with market cap. We try to consider non-financial initiatives we should refer to while aiming to enhance our enterprise value going forward as so.

Next up is the last part of our company presentation. Director Takashi Tanaka will talk about updates on Astellas' corporate governance. Tanaka [Non-English content], please.

Takashi Tanaka
Outside Director, Chair of the Nomination Committee, and Chair of the Compensation Committee, Astellas Pharma

Hello, everyone. I am Takashi Tanaka, an outside director. I serve as the chair of the nomination committee and the chair of the compensation committee. I will talk about FY 2024 corporate governance updates at Astellas. Today, Ms. Mika Nakayama, another outside director, is also in attendance. She will respond to questions later during the Q&A session. Page 22. I became an outside director at Astellas in June 2021. In June 2023, I took office as the chair of the nomination committee and the chair of the compensation committee. Ms. Nakayama became an outside director in June 2022. She has served as the chair of the audit and supervisory committee since June 2024. Page 23.

As the first topic, the ratio of female directors on the board of directors increased from 27% as of June 2023 to 45% as of June 2024. At present, we have 11 board members, and six of them are male and five are female. Astellas agrees with the challenge for 30% by 2030 proposed by Keidanren. We have worked on initiatives to enhance the ratio of female directors and promote the diversity on the board of directors. The Japanese government set a numerical target of 30% or higher as the ratio of female by 2030 in its intensive policy for gender equality and the empowerment of women in 2024. The composition of a board of directors for FY 2024 meets this numerical target. The second topic is the appointment of an independent outside director as the chair of the audit and supervisory committee.

In June 2024, Ms. Nakayama, who is attending today, took office as the chair of the audit and supervisory committee. Up until FY 2023, in-house full-time audit and supervisory committee members served as the chair of the committee, but with the enhancement of support year after year from the audit and supervisory committee office established in 2020, a foundation has been established for independent outside directors to serve as the chair of the committee. This fiscal year, an independent outside director was appointed as the chair for the first time, making the independence of the audit and supervisory committee even clearer. The third topic is to further enhance independent outside directors' objective oversight. I will explain the details on the following pages. On page 24, I'll explain our new initiatives by independent outside directors, the establishment of EPM, Enterprise Priority Monitoring group.

In order to further make sure of our midterm growth, we have set and are working on the three Enterprise Priorities, the so-called 3EPs, which are closely aligned with our performance goals in the Corporate Strategic Plan CSP 2021. In order to further strengthen the independent outside directors' objective oversight of the 3EPs in their objective capacity, EPM has been established. EPM has three objectives. First, deepening the understanding of independent outside directors regarding the current status and outlook of our initiatives. Number two, achieving enhanced monitoring of the progress by the board of directors. Number three, exchange and coordination of opinions for the independent outside directors to provide oversight and advice at the board of directors. All independent outside directors are EPM members. I, Tanaka, serve as the chair, and Ms. Nakayama is the co-chair.

Activities started from November last year. We plan to continue activities until the end of FY 2025, when the ongoing CSP 2021 period will be over. In principle, our meeting will be held on a monthly basis. Next page, please. Page 25 shows an overview of our governance structure, including EPM. EPM is a new initiative we have launched within the existing Outside Directors' Meeting, which we call [Non-English content] in Japanese. Outside Directors' Meeting, [Non-English content], is attended by independent outside directors only. It supports an open and constructive exchange of opinions among outside directors. It's held monthly. It also serves as an opportunity for direct communication with the full-time audit and supervisory committee members and external financial auditors as well. EPM has been newly launched based on this meeting.

To the board of directors, overall progress of CSP 2021 is reported by management and is supervised by the board of directors.

The progress of the Three Enterprise Priorities, 3EPs, of particular importance is reported by management to EPM. In their objective capacity, independent outside directors deliberate these matters. If there is a need for advice based on expertise, we would also consider using external advisors. By reflecting those discussions on the board of directors' deliberations and supervision, we are further enhancing our directors' objective oversight. That's all from me about corporate governance updates. During the upcoming Q&A session, in our capacity as an Outside Director, I, together with Nakayama [Non-English content], will respond to your questions. Thank you very much.

Hiromitsu Ikeda
Chief Communications and Investor Relations Officer, Astellas Pharma

Thank you very much. This is all as a presentation from the company side. We would like to entertain your questions. If you have any questions, please use the raise hand button at the bottom of the Zoom screen. If you are on a smartphone, tap the details, and you can find the raise hand function, so please tap that. The moderator is going to call out your name. If your name is called upon, please unmute yourself on your screen and mention your name and affiliates to start the presentation. Please start.

Moderator

The first question is from Kazuaki [Non-English content], Daiwa Securities.

Kazuaki Hashiguchi
Analyst, Daiwa Securities

Kazuaki speaking. Thank you for this opportunity. The first question is about the submission activities for VYLOY. There you explained about the acceleration of the speed. If the quality is the same, of course, speed up is really welcome. When it comes to VYLOY, FDA provided to you the notification of the completion of the review, but gaining the actual approval was delayed.

As for the recent case, in the case of IZERVAY, the change of the package insert took place because of the question about the result of the statistical analysis, which leads to the delay. Of course, there are outside factors, not only your internal factors. For example, it seems that you had the causing factors outside of your company. Including the management for the outsourcing partners, I just wonder if this speed-up or acceleration is sacrificing the quality. Would you please elaborate more on this point?

Naoki Okamura
President and CEO, Astellas Pharma

Kazuaki [Non-English content], thank you very much for your question. First of all, the speed-up might sacrifice the quality. That is exactly what we are paying attention on to. The earlier is not always the better. Of course, earlier is better, but at the same time, I would like to enhance the quality.

On the other hand, the cases that you pointed out, VYLOY or IZERVAY, the complete response letter from FDA is well received. First of all, about VYLOY. The third-party audit issue happens amongst the outside manufacturing companies. That was the cause. CRL is given to us because of the acceleration of the speed. It's not really the case. We've been conducting the discussion with FDA in the case of IZERVAY. The final conclusion was that CRL, which was a great surprise for us. In either situation, if it is necessary to revisit and redo once again, then there should have been the pre-dialogue with the authority. This is not because of the speed-up. That's what I think. Thank you very much.

Kazuaki Hashiguchi
Analyst, Daiwa Securities

Next is questions about the setting EPM. Probably, I was not understanding it quite well. You have the conventional [Non-English content] or outside directors meeting. What was missing there? You have this EPM. With having this EPM compared to the past, what would be the addition? Would you please explain about that more? You introduced this kind of new system. That is probably, you might feel that the conventional outside directors meeting might not be sufficient. You might feel in that way; that is why you decided to set up EPM. Would you please explain about the background?

Takashi Tanaka
Outside Director, Chair of the Nomination Committee, and Chair of the Compensation Committee, Astellas Pharma

Tanaka speaking. Kazuaki [Non-English content], thank you very much for your question. First of all, about the objectives of setting EPM. I believe you see the slide here now. On this slide, you see the three company-wide priorities. Within the board of directors meeting, we have been discussed that we have to do that the further thorough tracking will be necessary.

The conventional [Non-English content] outside directors meeting, the discussion and coordination for a wider perspective. When it comes to EPM, we prioritize the 3EP. We specialize in the 3EPs for the discussions, and that result is going to be fed back to the board of directors meeting. That is the objectives of this meeting. The function of [Non-English content] outside directors meeting is insufficient. That might be the question, but, in EPM, more intense professional discussions will be performed to deepen the understanding and perform closer monitoring. I hope you understand. Also, if you look at this diagram on the left, as you can see there, where necessary, external advisors with expertise may be asked to give us their advice. That, I think, is the difference. I hope you understood. Thank you very much.

Kazuaki Hashiguchi
Analyst, Daiwa Securities

3EP. What are the 3EPs? Is that described somewhere?

Hiromitsu Ikeda
Chief Communications and Investor Relations Officer, Astellas Pharma

On this screen, on the right, you can find the 3EPs are. This is the 3EPs.

Kazuaki Hashiguchi
Analyst, Daiwa Securities

Understood. Thank you very much.

Moderator

Thank you very much. Next, Mr. Wakao from JP Morgan Securities. Wakao [Non-English content], please.

Seiji Wakao
Analyst, JPMorgan Securities

Thank you very much. Wakao from JP Morgan speaking. I have two questions. First, on page 11, I have a question. Engagement score was down, and you talked about the action to be taken. Can you take countermeasures sufficiently? Cost reduction program will be performed, so there would be further transformation. Organizational capabilities can be maintained sufficiently because of the cost reductions, no more risk of further reduction? On this page, regarding the change communication, this score, what's the biggest issue to be addressed? I wonder where it's described. This will lead to an improvement? I was not clear, so could you please explain? Including the data in 2021. There was a peak in 2023, and there's a decrease in 2024. For the past one year, anything happened? Transformation was ongoing. I was concerned about the decline in the past year.

What happened? Cost reductions and additional transformation will occur. Can you maintain organizational capabilities? That's something I also would like to know.

Naoki Okamura
President and CEO, Astellas Pharma

Thank you for your question. Today, Sugita is not attending, so I'd like to respond from my side. First of all, engagement score in the current fiscal year was down. There are multiple various factors behind, as Wakao [Non-English content] said, transformation did not start just this year. We are doing transformation all the time. On the other hand, global engagement survey timing and various measures are to be shown to employees. The timing, global engagement survey, as you know, perhaps depending on the countries, there's a difference in the trend of the scores. The results may be very good in some countries and not so much in other countries because of the employee mix. There can be a variability in the scores as a tendency.

Also regarding the questions, regarding the transformation, communication, and transformation, regarding those questions, because we hear such an opinion, this question was added in 2024. Can we evaluate all the scores equally? Not necessarily. That's part of the assumptions I'd like to explain. Various transformations, in particular cost reduction, will have an impact on organizational capabilities, the data of transformation, and in implementing the transformation, the leaders will take the lead. How they're going to take the lead, it will depend on those aspects. It should not be the cost reduction for the sake of cost reduction. It doesn't make sense. Company's capabilities must be maintained or even enhanced based on such assumptions. We'd like to curtail and optimize cost. That's what we mean by cost reduction. There are 3EPs. The third one is Sustainable Margin Transformation.

It must be sustainable; that's the assumption. It's not just a mere cost reduction for any items. Sustainable Margin Transformation: When I talk about it, most of the people say, We are going to reduce the headcount. No, that's not the case. Clinical studies were mostly performed by depending on CROs, but we are now on the way to do it in-house. Large clinical studies. If you are to do so, it's more efficient to ask CRO to support us. If you look at the current future portfolio, we can do this on our own. We can communicate with investigators directly, then that's good for the studies per se. Also, we can enhance the understanding of the product. We had a conclusion that it's better to do this internally.

By having the development work internally, we need more people, and personnel costs will increase, but we can reduce outsourcing costs for CROs. On a net basis, the margin will be higher. That's what we mean by Sustainable Margin Transformation. Our transformation, lowering our organization capabilities overnight, or change fatigue, so to speak. Because of a transformation, one after another, people may be fatigued. We hear such a voice, so we have to capture such voice and take necessary measures. There should be no damage on the organization, and we shouldn't lose the capabilities we have, so we have to be very careful in doing this.

Seiji Wakao
Analyst, JPMorgan Securities

Understood. In that case, there is the transformation fatigue currently ongoing, but as of this moment, it is okay not thinking about. It is okay not going down further from this status, although there is a voice of the transformation fatigue.

Naoki Okamura
President and CEO, Astellas Pharma

Yes. We are going to work on that to avoid such situation.

Seiji Wakao
Analyst, JPMorgan Securities

Well, no explanation today, but I would like to ask you about the supply chain, more specifically about the tariff in the U.S., the +25% for the pharmaceutical products as well. As for this point, is any impact onto Astellas? Once this 25% tariff becomes realistic and real, do you think you can counter with this situation, and you can minimize the impact of that?

Naoki Okamura
President and CEO, Astellas Pharma

Thank you for the question. I don't know if it's all of a sudden, but relatively speaking, only recently that discussions got started. We are going to do the further elaboration on that.

We are more complicated global operation; it's not really the situation whether that we produce the products on local and that is used at the same local area. Some products are not produced in the U.S.; such products are imported from outside, and if that tariff is applied for that, we have to, of course, think about the countermeasures for that. For example, having the factory established in the U.S., that kind of thing is what we cannot do. We are going to have some thinking about the supply chain, and even if some tariff is applied, we do not bring that effect onto the price of the products of the customers. We have a lot of ways that we could think about. Well, we've closed a certain factory in the U.S.

In order to deal with this tariff situation, all the products of Astellas are going to be produced within one factory in the U.S. Of course, that is not happening , as Wakao [non-English content], you know. We are not thinking about dealing with the situation in that way.

Seiji Wakao
Analyst, JPMorgan Securities

I see. This is not the financial call; this might not be the right place to ask you, but qualitatively, if this tariff is applied, there might be a certain impact?

Naoki Okamura
President and CEO, Astellas Pharma

Well, in this meeting, I cannot say how big or small the impact would be, or the amount is bigger or lower. Maybe it would be explained in other opportunities.

Seiji Wakao
Analyst, JPMorgan Securities

Understood. Thank you very much.

Moderator

Next question is Sumitomo Mitsui Trust Asset Management, Kohguchi [Non-English content].

Shinichi Kohguchi
Analyst, Sumitomo Mitsui Trust Asset Management

Kohguchi is speaking. Can you hear me?

Hiromitsu Ikeda
Chief Communications and Investor Relations Officer, Astellas Pharma

Yes, we can hear you.

Shinichi Kohguchi
Analyst, Sumitomo Mitsui Trust Asset Management

Taking this opportunity, I would like to ask a question to Iino-san. Social impacts. Monetary valuation is really what I got impressed, but this JPY 680 million, that is the amount of the social impact. How can I interpret this? The output outcome against input and quantification for that, in that sense, I understand about this. But this absolute monetary amount, how should we interpret that? How do you want us to interpret? Would you please explain about it? That's the first question from me.

Shingo Iino
Head of Sustainability, Astellas Pharma

Kohguchi [Non-English content], thank you very much for your question. That is a very important point and question. As I've explained in the presentation, so far, to the countries or the regions where the healthcare is fragile, we provide the support so that the health system can enhance. For that purpose, the donation is done multiple times from Astellas.

Yes, we do such kind of activities and initiative, we didn't know the impact of such a donation. Of course, we are said. Thank you very much. It was useful. Actual monetary amount as the contribution from us and to what extent of value that is linked to was not visualized. We wanted to see that for the first time, we decided to do this calculation. It's about JPY 160 million, is the investment that we've done. This is the activities for five different types of the cancers. This calculation this time is focusing only on the colorectal cancer. We focused on this because the data is relatively available in the market for the calculation. Our result, this is a 4.64 times of the result. With this support, in Malaysia, we were able to realize positive impact, and that was visualized.

In that sense, this is meaningful that we think.

Shinichi Kohguchi
Analyst, Sumitomo Mitsui Trust Asset Management

In that sense, 4.6 times of the impact, you have certain effect, which you think is important, and you want us to understand that point.

Shingo Iino
Head of Sustainability, Astellas Pharma

Yes. I hope you understand that way.

Shinichi Kohguchi
Analyst, Sumitomo Mitsui Trust Asset Management

Understood. Thank you very much. You will increase tumor types and programs in other countries. You're going to do something similar?

Shingo Iino
Head of Sustainability, Astellas Pharma

The available data cannot be found so easily in the world. Without such data, even if I want to do this, I cannot. That's the reality.

Shinichi Kohguchi
Analyst, Sumitomo Mitsui Trust Asset Management

Understood.

Shingo Iino
Head of Sustainability, Astellas Pharma

It may be up to the judgment by CEO, perhaps.

Shinichi Kohguchi
Analyst, Sumitomo Mitsui Trust Asset Management

Next, number two, the relationship between the non-financial indicators or market cap. The percentage of female managers. In this way, you found a relationship or connection. The ratio of female managers in Japan is low, which is a challenge for you. Because of this supporting data, you're going to work on this more. Are you declaring such intention?

Shingo Iino
Head of Sustainability, Astellas Pharma

Thank you for your question. Let me respond. Of course, the ratio of female managers in Japan is still low. That's the actual situation. We will continue to make efforts in this regard. On the other hand, appointing females to managers because they are female, or if there are male and female candidates, selecting female candidates with priority. No. There should be equal opportunities between both genders when we appoint them. The individual's capabilities and the past experience and their motivation for work would be evaluated fairly to determine whether we will appoint them to certain positions. The ratio of female managers, in order to increase the ratio, increasing the number of female managers should not happen. We shouldn't have put the cart before the horse.

Shinichi Kohguchi
Analyst, Sumitomo Mitsui Trust Asset Management

Lastly, I'd like you to let me know how to read this. The average remuneration paid to directors, there was a positive correlation there. The remuneration may be very big, but market cap may not increase for certain company. How should I think? How should I read? I'd like to hear your view.

Shingo Iino
Head of Sustainability, Astellas Pharma

Right. 1,700 companies listed on the Tokyo Stock Exchange Prime Market were analyzed; these are the analysis results. Among them, as Shinichi [Non-English content] said, some may not match these results. As a result of the data analysis, these were the outcome we saw. As I mentioned when I talked about limitation, the number of data, even if we collect data from 1,700 companies, it's not rich. Just for 11 years. We have to increase our data further; otherwise, we cannot say anything accurate.

Shinichi Kohguchi
Analyst, Sumitomo Mitsui Trust Asset Management

Understood. Thank you very much. Thank you very much for challenging initiatives.

Moderator

Thank you very much. Next, Nissay Asset Management. Yatsunami [Non-English content], please.

Junko Yatsunami
Analyst, Nissay Asset Management

Junko from Nissay Asset. Thank you very much. Today, I have two questions to you. First, as Kohguchi [Non-English content] asked on page 16, non-financial indicators and the enterprise value, you analyze the relationship, and thank you for sharing the results. According to the explanation, there is still some limitation to the available data. Based on this, reflecting this onto your corporate strategy, you cannot do so yet, as I understood. According to your analysis, by now, human resource capital, human resources, and also corporate management. How you are going to turn this into KPIs specifically, do you have any idea?

Naoki Okamura
President and CEO, Astellas Pharma

Yes, Yatsunami [Non-English content], thank you very much for your question. How to understand about the results of this analysis this time? Well, the sustainability or digital divisions, for them, they did a really challenging thing, and I recognized and acknowledge their effort. As for this result, from here, rather than that, we did this result in order to identify what should be done, or rather, we wanted to review what we have done is really heading toward the right direction. This is used as a verification of what we have done. Data has to be more sufficient, or the method of the analysis should be more precise. Those two are both sides of the coin.

In this situation, is it okay to make a further investment based upon this result? We haven't really convinced that level yet. This might be the repetition, but the span of control to be expanded so that we can have the flat organization, we thought that is important. With that, management percentage is heading toward the opposite direction of the enterprise value. We learned that. At least what we have done is not a wrong thing. At least we were able to verify that. Please interpret this in that way.

Junko Yatsunami
Analyst, Nissay Asset Management

I see. To the capital market, so that you can have a certain KPI that can be shared with the investment market, do you think you will make it?

Naoki Okamura
President and CEO, Astellas Pharma

Well, if we can capture even the smaller delta, in that case, this could be reflected into the KPI. It might be not really good to say about this in front of Iino-san. He might be sad, but this is, yes, quantification, but it is not that precise. We think it is better not rush to reflecting this as KPI.

Junko Yatsunami
Analyst, Nissay Asset Management

Thank you very much. Sharing this result is really good for, or is meaningful for, the investors because this is giving us the certain view. About page 25, EPM, the outside directors are going to be utilized just like Tanaka [Non-English content] mentioned, external advisors. If it is possible, I didn't understand if you have done this already or this is about future, but in what situation these external advisors are used, are going to be used? Could you share with us some specific examples?

Naoki Okamura
President and CEO, Astellas Pharma

Yatsunami [Non-English content], thank you very much for your question. Let me answer your question. First of all, EPM activities has got started November last year. Roughly monthly, we are having the activity. If we made use of external advisors or not, as of this moment, we didn't use external advisors. As you see, as needed. It is the situation. We have the outside directors in this member, and you can see the metrics here, and the people from various fields are the members. When the things are difficult to understand only by ourselves, in that case, as needed, we receive advice from experts. Please do understand in that way. That is all from me. Thank you very much.

Junko Yatsunami
Analyst, Nissay Asset Management

When we look at this, because you are a pharmaceutical company, so the scientific information for the pharmaceutical industry, like M&A or development cases or transactions, if they are necessary to be discussed within the directors' meeting, you might seek for the external advisors' opinions or the advice. Is that the case?

Naoki Okamura
President and CEO, Astellas Pharma

As of this moment, we haven't been that level of the specificity phase. There might be the possibility, however, but at this moment, we haven't identified specifically, just like you said.

Junko Yatsunami
Analyst, Nissay Asset Management

Understand. That is all from me. Thank you very much.

Moderator

Thank you. Next question, Morgan Stanley Securities, Muraoka [Non-English content], please. Muraoka [Non-English content], please.

Shinichiro Muraoka
Analyst, Morgan Stanley Securities

Hello. Muraoka from Morgan Stanley speaking. Thank you very much. Engagement survey. As Wakao [Non-English content] asked a question earlier, in the appendix slides, looking at those pages, I was very surprised. Page 27 and onwards, specific items, individual items are shown. You talked about communication, which is a new additional question, so I was able to understand that. Also, the trust in management and growth opportunities

The promotion policy. If I were the management, I would be shocked because of the decrease in certain items. Okamura [Non-English content] said that there can be some items which may change in scores. A single survey would change the direction. That might be a question, but how do you perceive the survey results as management? Maybe also directors as well, how do you see these results? What's your perception? I would like to hear your view.

Naoki Okamura
President and CEO, Astellas Pharma

Thank you very much. We perform the survey, we take the results very seriously. Particularly, there was a big change for some of the items; in order to identify the causes behind, by having subgroups, we have interviews and exchanging opinions as well. As CEO, if you ask me whether I'm happy, no. That does not start anything. What I'm going to do next, this should be seen as an opportunity for the next step. What can be improved further? That's something I'm considering every day. How do I perceive this from outside? Nakayama [Non-English content]? Nakayama would like to comment on these results.

Mika Nakayama
Outside Director, Chair of the Audit and Supervisory Committee, Astellas Pharma

Looking at the results, a reduction in score, including the management, we have to take it seriously. For the past one year or two, HR measures and organizational change; looking at such a situation at Astellas, the responses reflect the candid opinion of the employees. If they face such a big transformation, if the score goes up, that's not natural from outside. On a temporary basis, I think this is a natural flow or course among employees. The management, in order to improve the scores, have to consider the measures to be taken; they need to focus on the deep understanding. Negative results or decrease are not so good; I hope that they would come up with better measures for the future.

Shinichiro Muraoka
Analyst, Morgan Stanley Securities

Thank you very much. As Mr. Okamura [Non-English content] explained, there is some difference among different countries. I was able to understand it, but what about the particular difference among Japan, U.S., and Europe leading to the differences? If you give me a clue, that would lead to better understanding next time.

Naoki Okamura
President and CEO, Astellas Pharma

I don't have specific data at hand. In my discussions with Sugita, please listen, this is based on my ambiguous memory. Japanese employees may account for a majority. Japanese employees are not just our company, but in an engagement survey like this, they're rather conservative. Even if they are happy, they may say, It's usual or normal as a trend. On the other hand, China and Latin America, Central and South America, or Southern Europe tend to have a higher score. I hear such a trend or tendency. If the sample size is at a certain level or higher, we may specify who responded how. We don't evaluate by groups or divisions unless they have a certain number. If they have a bigger number of people, what happened in that group in that year may have an impact in sales or marketing.

If there is something in sales in Japan, that would affect the bigger group; the results could be affected.

Shinichiro Muraoka
Analyst, Morgan Stanley Securities

Thank you very much. Now I have better understanding. Thank you. Another question that is about the tariff issue. That tariff issue was asked in the previous questions; there was the answer about the absorption of that portion with the reduction of the cost and so on. Of course, I understand the situation is not clear; nothing has been decided. As one of the countermeasures, you didn't mention about the increase of the price. Increase of the price is one of the important options. Of course, it's not easy to simply say about the increase of the price, but why didn't you say that?

Naoki Okamura
President and CEO, Astellas Pharma

Right. Increase of the price is not something simply and easily stated. I rather would not refrain from talking about that today.

Shinichiro Muraoka
Analyst, Morgan Stanley Securities

Understand. Thank you very much.

Hiromitsu Ikeda
Chief Communications and Investor Relations Officer, Astellas Pharma

It's the time. With this, I would like to close this Sustainability Meeting 2024. Thank you very much for your participation.