Thank you very much for your attendance in this Fiscal 2025 Earnings Call by Astellas Inc. I am Kato, Chief Communications and IR Officer. I would like to serve as a moderator for today. Following our presentation today, we will move on to the Q&A session. The presentation will be based on the presentation materials available on our website. Simultaneous interpretation in Japanese and English will be provided throughout the event, including the Q&A session. Please note that we cannot guarantee the accuracy of it. You can select your preferred language from the menu at the top of the Zoom webinar screen. If you select the original language, you will be able to listen to the audio in the original language without simultaneous interpretation. This is some note from us.
This material, oral presentation, and answers and a statement in the Q&A session includes forward-looking statements based on assumptions and beliefs in light of the information currently available to management and are 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 is not intended to make any advertisements nor provide medical advice of any kind.
Now, let me introduce you to the participants from Astellas here today. Naoki Okamura, President and CEO. Chief Research and Development Officer, Tadaaki Taniguchi. Chief Commercial and Medical Affairs Officer, Claus Zieler. CFO, Atsushi Kitamura. These four are attending in this meeting.
Now I would like to start the presentation. Okamura-san, the floor is yours.
Hello, everyone. I'm Naoki Okamura from Astellas Pharma, Inc. Thank you very much for joining our FY 2025 financial results announcement meeting out of a very busy schedule today. This is a cautionary statement regarding forward-looking information. As this was explained by Kato earlier, I'm not going to read this page. Page three is the agenda for today. First, I start with FY 2025 financial results. On page four, I will give you an overview of FY 2025 results. Revenue reached over JPY 2.1 trillion, and Core Operating Profit exceeded JPY 550 billion. Both achieved record high results. Significant growth of strategic brands by over JPY 140 billion year-on-year has driven double-digit revenue growth.
As for SG&A expenses, thanks to the robust progress of what we call SMT, Sustainable Margin Transformation, a company-wide cost optimization initiative, SG&A ratio improved by 2.3 percentage points year-on-year. Driven by strategic brands growth and robust cost management through SMT, Core Operating Profit rose significantly, up by 42% year-on-year. Core Operating Profit margin increased by 5.5 percentage points year-on-year to reach 26%. Our pipeline also progressed substantially. PADCEV made significant progress in MIBC, muscle invasive bladder cancer development. Following POC achievement by setidegrasib in PDAC, pancreatic ductal adenocarcinoma in FY 2024, a total of three POCs were achieved in FY 2025, namely setidegrasib for NSCLC, ASP2138 and ASP7317. For setidegrasib, phase III study was initiated for PDAC in the first-line settings.
Promising external assets ASP546C and VIR-5500 were licensed in, and our pipeline expansion made progress. On page five, I will explain FY 2025 financial results. Across revenue, core operating profit and full operating profit, we broke records to hit all-time high since the founding of Astellas. Let me explain main items. Revenue exceeded the JPY 2 trillion mark for the first time to reach JPY 2,139.2 billion, up by 11.9% year-on-year, achieving a double-digit growth for two consecutive years. Core operating profits substantially exceeded the JPY 500 billion mark to reach JPY 555.7 billion, significantly increasing by 41.6% year-on-year. The bottom half of this page shows our full basis results.
Operating profit was JPY 382.6 billion, and profit was JPY 291.6 billion. Both rose significantly year- on- year. On page six, I will explain FY 2025 financial results of our main brands. Sales of all brands increased across the board, with strategic brand sales combined strongly growing by over JPY 140 billion in total year on year. First, sales of five strategic brands, namely PADCEV, IZERVAY, VYLOY, VEOZAH, and XOSPATA, reached JPY 480 billion in total, substantially up by JPY 143.9 billion or 43% year- on- year. PADCEV and VYLOY in particular drove the strong growth, increasing by more than JPY 50 billion respectively. Strategic brands have high profitability, and their growth made a great contribution to the FY 2025 consolidated revenue and profit increase as a whole.
Next, I will explain individual strategic brands and XTANDI. PADCEV sales increased to JPY 221.2 billion, up by JPY 57.1 billion or 35% year-on-year. Global sales growth was driven by strong first-line MUC penetration continuously. Sales expanded in all regions. In addition, early momentum for CIS-ineligible MIBC, approved in November last year in the United States, also contributed greatly to sales expansion. As for IZERVAY, sales rose to JPY 77.6 billion, up by JPY 19.3 billion or 33% year-on-year. New patient starts, which are important metrics, steadily increased. In the recent fourth quarter between January and March, demand grew more than 10% quarter-on-quarter. Treatment rate for complement inhibitors as a whole, including the competitor's product, rose to about 20%. Market penetration made steady progress.
With regards to VYLOY, sales reached JPY 63.1 billion, substantially up by JPY 50.9 billion year-on-year, significantly exceeding our initial expectations. Market penetration progressed extremely well across all regions. High claudin 18.2 testing rates contributed greatly to strong performance. VEOZAH and XOSPATA sales rose steadily respectively. XTANDI sales increased to JPY 960.8 billion, up by JPY 48.5 billion or 5% year-on-year, reaching projected peak sales levels 13 years after launch. Page seven is about cost items. With SMT initiative, we realized cost optimization of about JPY 25 billion in FY 2025 for SG&A expenses, R&D expenditure, and cost of sales combined. Partly due to the SMT effect, excluding U.S. XTANDI co-promotion fees, SG&A cost ratio improved by 2.3 percentage points year-on-year.
Let me explain a specific breakdown of SG&A costs and R&D expenditure. SG&A expenses, excluding FX impact, rose by 2.6% year-on-year. While we increased our revenue by more than 10%, we are able to manage SG&A expenses at a level almost similar to the previous year. Investment toward further growth of strategic brands was increased by about JPY 10 billion year-on-year. On the other hand, as for SMT progress, we realize cost optimization of about JPY 11 billion through steady progress in continuous global organizational restructuring, reduction of mature products related expenses, and streamlining IT infrastructures, etc. As a result, while fully executing investments for strategic brands, we were able to offset the increase through SMT cost optimization according to assessment.
R&D expenditure, excluding FX impact, decreased by 3.8% year-on-year. While clinical development costs for pipelines such as setidegrasib and ASP546C increased by about JPY 5 billion, we made progress in outsourcing cost reduction through insourcing development capabilities, including clinical trials, et cetera, under SMT, which led to cost optimization of about JPY 10 billion. We were able to fully offset the cost increase factors. In addition, with the completion of large clinical studies, development costs for strategic brands decreased by about JPY 5 billion.
Page eight shows life cycle management of strategic brands. Let me explain main achievements in FY 2025. Updates since the last financial results announcement are shown in blue, including the achievements in April 2026. Strong development progress was made toward maximization of our strategic brands' value, notably for PADCEV. I will explain the latest status of PADCEV on the next page. Regarding VEOZAH, in phase II study in China, primary endpoint was met in April this year. Based on the study results, we are planning to file a submission in China.
On page nine, I will explain the latest status of PADCEV development in MIBC. In addition to development in the perioperative settings we have worked on so far, we also started development for bladder-sparing MIBC to potentially maximize PADCEV's impact. As for CIS-eligible MIBC shown on the left, we presented the latest data from EV-304 study at ASCO GU in February. As is shown in the figure, perioperative PADCEV and pembrolizumab significantly improved EFS, event-free survival, a primary endpoint, compared to neoadjuvant chemotherapy. Also, OS, overall survival, and pCR, pathological complete response, improved significantly as well. Based on the study results, we took procedures for an additional indication globally.
Regulatory applications were accepted in Europe in March. In the United States in April this year. In the U.S., we were granted priority review designation with PDUFA date set for August 17, 2026. Next, let me explain the right-hand side, development for bladder-sparing MIBC as an opportunity to further growth. It is known that about 30% of MIBC patients are ineligible for or refuse radical cystectomy, or RC. These patients will not be eligible for EV-303 or EV-304 studies. There are high unmet medical needs for treatment option that delays or avoids RC and preserves the bladder. Based on the extremely favorable data obtained consistently from clinical studies in MIBC by now, we initiated development of PADCEV for bladder-sparing MIBC. EV-209 is a single-arm phase II study initiated in April.
The study enrolls MIBC patients who are eligible for but select not to undergo RC to evaluate the efficacy and safety of PADCEV and pembrolizumab combination. PADCEV is administered in nine cycles. The same duration of treatment with MIBC studies so far. Primary endpoint are clinical complete response, CCR, and bladder intact event-free survival, BI-EFS, at two years. In addition, EV-309 as a registrational phase III study is under preparation in parallel. We are planning to start this study in the first half of FY 2026. Also in China, regulatory application is under preparation based on EV-303 and EV-304 studies. Bladder-sparing treatment in China are not factored in to our current peak sales forecast for PADCEV. If successful, there can be further upside potential.
On page 10, regarding focus area approach, I will explain main achievements in FY 2025. Achievements made in April 2026 are also included here. Over the past one year, our pipeline made a significant progress and expansion with three POCs achieved, one phase III study initiated, three clinical entries, and two promising external assets in-licensed. ASP2138 in immuno-oncology achieved POC in gastric and GEJ, gastroesophageal junction adenocarcinoma. Preparation is now underway for rapid initiation of phase III study. Furthermore, as a follow-on program, we licensed in VIR-5500 from Vir Biotechnology. ASP2998 made clinical entry to expand our portfolio. setidegrasib in TPD, targeted protein degradation, achieved multiple important progresses.
In PDAC, where POC was achieved at the end of FY 2024, phase III study was initiated in the first-line settings. Furthermore, POC was achieved also in non-small cell NSCLC. Phase III study is now under preparation. In addition, ASP5834, a pan-KRAS degrader, also made the clinical entry. Pipeline expansion is making steady progress. As for AT845 in genetic regulation, additional analysis is ongoing for POC judgment. ASP2957 also made the clinical entry. New programs including ASP2998 in immuno-oncology will be explained in detail on the next page. ASP7317 in blindness and regeneration achieved POC in patients with severe vision impairment due to GA, geographic atrophy. The next study plan is now under discussion with the regulatory authorities.
We licensed in ASP546C from Evopoint to further solidify our leadership position in the claudin 18.2 space. On page 11, I will explain new clinical programs. Next-generation innovative programs have advanced into clinical development. ASP2998 is a program which leverages a platform called immunostimulatory ADC, or iADC, generated from joint research with Sutro. Trop-2 directed monoclonal antibody is conjugated with two payloads, cytotoxic topoisomerase one inhibitor and immunomodulator STING agonist. In non-clinical studies in mouse model, superior efficacy was demonstrated versus the existing Trop-2-directed ADCs. From now on, efficacy and safety will be confirmed in human clinical studies.
ASP2957 has been created as a gene therapy for XLMTM, X-linked myotubular myopathy, like AT132. It uses a novel muscle-targeted AAV capsid. High muscle specificity and reduced liver targeting was demonstrated in non-clinical studies. This enables clinical study initiation at a dose level about 100-fold lower compared to AT132. With the progress of ASP2957. We decided on a strategic hold for AT132.
Moving forward, we will focus on the development of ASP2957 as a gene therapy for XLMTM. ASP2246 is a program to aim for recovery from motor dysfunction associated with ischemic stroke by using an approach called direct reprogramming. Messenger RNA, encoding human NeuroD1, is encapsulated in novel LNP lipid nanoparticles to enhance efficiency of delivery into cells. Messenger RNA, encoding human NeuroD1, promotes conversion of brain astrocytes into neurons and induces neuronal regeneration.
In a non-clinical study using a monkey model, improved motor dysfunction was demonstrated with intracerebral infusion of ASP2246. Phase I/II study enrollment has been initiated by now. FSD, First Subject Dosed, is anticipated for the first quarter of FY 2026. You can find non-clinical study data of these programs summarized on page 37 in the appendix, so please refer to it at your leisure. From here, I will explain FY 2026 outlook.
On page 13, I will explain an overview of FY 2026 outlook. In FY 2026, our performance is forecasted to reach record-high results. Revenue is expected to expand over JPY 2.2 trillion, driven by growth of strategic brands by over JPY 130 billion year-on-year, according to our forecast. Due to this significant growth, we're expecting a revenue increase. Regarding cost items, we will continue SMT initiative to achieve about JPY 40 billion cost optimization. SG&A ratio is expected to improve by 2.3 percentage points year-on-year. We plan to increase investment in R&D in line with the growing number of new phase III trials. Core OP is expected to increase by 12% to over JPY 600 billion. The core OP margin is projected to rise to 27.9%.
In our pipeline regarding PADCEV for MIBC, we plan to conduct multiple filings and regulatory decisions, as well as initiate new phase III trials. We also plan to initiate the phase III trials for setidegrasib and ASP2138. Regarding shareholder returns, we forecast dividend per share at JPY 80, up JPY 2. On page 14, I will explain the full year focus for FY 2026. For FY 2026, we anticipate revenue of over JPY 2.2 trillion and a core OP of over JPY 600 billion, surpassing the record high achieved in FY 2025. First, for Forex rates, we are assuming JPY 150 to the U.S. dollar and JPY 180 to the euro for FY 2026. We forecast revenue of JPY 2.22 trillion, an increase of JPY 80.8 billion year-on-year.
Although we anticipate a decline in sales of XTANDI, we expect to secure overall revenue growth driven by a strong performance of strategic brands. We forecast SG&A expenses of JPY 800 billion, down JPY 60.3 billion year-on-year. Of this amount, XTANDI co-promotion expenses in the U.S. are expected to decrease in line with the decline in its U.S. sales. Excluding co-promotion expenses, SG&A is projected to be JPY 584 billion, down JPY 28.1 billion year-on-year. The cost optimization through SMT is estimated at about JPY 40 billion. The majority of this relates to SG&A optimization, as expected to contribute to the reduction in SG&A. R&D expenses are projected to be JPY 355 billion, up JPY 42.2 billion year-on-year.
This increase is primarily due to the high year clinical development costs, including investments of phase III studies. To further solidify our mid to long term growth, we will accelerate investment in promising pipeline candidates such as setidegrasib, ASP2138, ASP546C, and VIR-5500, in addition to the lifecycle management of PADCEV and VYLOY. As development progress, we expect to continue investing at this level or higher. As a result, the focus is Core OP of JPY 620 billion, up JPY 64.3 billion year-on-year, representing double-digit growth of 12%. We anticipate the growth in our strategic brands and cost optimization through the SMT will contribute significantly to this profit increase. We expect the Core OP margin to be 27.9%, up 2 percentage points year-on-year. Next is the full business operating profit.
As a major adjustment item excluded from the core basis, we anticipate amortization of intangible assets of about JPY 140 billion. Additionally, we have factored in about JPY 80 billion in other expenses. This includes impairment loss risks of about JPY 40 billion and costs associated with organizational restructuring. As a result, we forecast operating profit of JPY 395 billion, an increase of JPY 12.4 billion year-on-year. Page 15, the explanation, the outlook for our main brands of FY 2026. The strategic brands will continue to drive growth in consolidated revenue and profit, with the particular contributions expected from PADCEV, IZERVAY and VYLOY.
We anticipate double-digit growth for each of these brands, with total sales expected to exceed the JPY 600 billion mark and reaching JPY 610 billion, year-on-year increase of about JPY 130 billion or 27%. We safely expect continued strong growth driven by our further market penetration of first line MUC. In particular, we anticipate growth in E.U., where both medicines grow, also addressing. In the U.S., in addition to the full year contribution from cisplatin ineligible MIBC, we anticipate sales contributions from the cisplatin eligible MIBC indication for which the filing was recently accepted starting during the current fiscal year. XTANDI expected to see steady sales growth building on the sales infrastructure expanded last fiscal year. We will further strengthen promotion activities and through GDC initiatives.
We will aim to expand in the complement inhibitor market and increase the number of new patients. By IZERVAY, we anticipate a continued solid growth across all regions, driven by a further increase in testing rates and expansion of the patient base and market share. We expect steady growth for both VEOZAH and XOSPATA. Excluding the negative impact of the price reduction associated with the IRA, which takes effect in January 2027 in the U.S., is expected to become apparent starting in the fourth quarter. In addition, combined with the impact of patent expiration in certain countries, global sales are expected to decrease by about JPY 50 billion year-on-year. Please note that starting in fiscal year 2026, we have discontinued the disclosure of sales forecast for individual products.
We believe it is important to grow our five strategic brands as one whole, and we hope to engage in dialogue focused on short-mid to long-term growth trajectory, rather than being preoccupied with the short-term fluctuations in individual products. Regarding XTANDI and PADCEV background, we anticipate they will be significantly affected by external factors such as patent situations in the future. As an exception, we are disclosing their sales forecast for your better understanding of our assumptions and outlook. Going forward, through timely and appropriate information disclosure and communication, we will continue to strive to enhance our mid to long-term corporate value by engaging a constructive dialogue with investors.
Page 16. About the lifecycle management of the strategic brands, I will explain the major events expected in FY 2026. We are expecting multiple regulatory events across strategic brands. For PADCEV, we expect regulatory decisions on the E.U. and Japanese filing based on the EV-303 study for cisplatin-ineligible MIBC in the first and second halves of the fiscal year respectively. In addition, I expect a Japanese filing based on the EV-304 study for cisplatin-eligible MIBC in the first quarter, with regulatory decisions for the U.S. and E.U. submissions anticipated in the second quarter and the second half of the fiscal year respectively. Furthermore, plan to file in China based on both, the EV-303 and EV-304 studies in the first quarter. We also plan to initiate the phase III EV-309 study for bladder sparing therapy in the first half of the fiscal year.
Otherwise, we plan to file in China in the first quarter. There are currently no approved treatments in China for geographic atrophy, a serious condition. Following constructive discussions with the authorities, we plan to file based on data from overseas clinical trials. VEOZAH, we expect study data read out from the STARLIGHT-3 trial, which evaluates long-term safety in Japanese women, to become available in the first quarter, and we plan to file in Japan in the second quarter based on those results. We also plan to file in China in the third quarter.
On page 17, this is an outline of the key pipeline events expected in FY 2026. We plan to initiate phase II trials for ASP2138 in first-line gastric cancer and AT845 in second-line or later non-small cell lung cancer in the first half of the fiscal year. We are also considering announcing additional data for each of these studies within the current fiscal year. Details will be provided once the announcements are officially confirmed.
Although this is an ex-event that has already been achieved, we initiated a global phase I-B/ II study of ASP546C led by Astellas in April. ASP7317 will represent additional data from phase I-B trial at ARVO, Association for Research in Vision and Ophthalmology in May. AT845, we are currently conducting additional analysis of POC judgment and expect to reach a decision in the first half of the fiscal year. Finally, I would like to review Corporate Strategic Plan for our CSP 2021.
On page 19, I'll explain the transformation of our organizational culture and operating model that we undertook during the CSP 2021 period. As a foundation to continuously generate innovations, we have implemented various initiatives related to human resources and organizational structure and have embedded them across the company. In fostering our organizational culture, we established organizational health goals at the start of the CSP 2021 and advancing efforts company-wide. As reported in the previous sustainability meetings, we have achieved some, many, results directly linked to our business over the past five years, excuse me.
Furthermore, in April 2025, we simplified and consolidated our culture foundation to define organizational values and behavior. By ensuring that every employee acts based on a clear shared understanding, we aim to strengthen collaboration and create and deliver greater value to patients more quickly. We have also significantly transformed our operating models. Under the new structure launched in April 2025, we shifted the top-level management focus from regional or functional to a patient axis and introduced an end-to-end business model. With empowering cross-functional teams organized around programs and brands and strongly promoting agile ways of working, we have enabled clear and rapid decision-making, thereby improving productivity and efficiency.
Page 20. The review of the performance goals in CSP 2021. Overall, we believe we have succeeded in establishing a foundation to overcome extended exclusivity and deliver sustainable growth beyond it, which was our original objective. Regarding performance goal one, revenue. Thanks to our newly launched products such as VEOZAH, IZERVAY, VYLOY, and the acceleration of lifecycle management centered on PADCEV, the total sales of the strategic brands and the established exceeded JPY 1.4 trillion. Performance goal two, pipeline value. We face a situation where programs already underway at the start of CSP 2021 did not progress as anticipated.
However, as explained at the R&D Day in March, we thoroughly focused on strength and discipline, improving productivity through the transformation of our R&D organization, and by accelerating the development of priority programs, we achieved significant progress in expansion of the pipeline, including the achievement of total of four POC. About performance goals, three, core operating margin. While we made investment associated with the launch of multiple new products, the SMT initiative progressed well, achieving cumulative cost optimization of JPY 65 billion over two years. As a result, the core OP margin for FY 2025 reached 26%, up 4 percentage points year on year compared to FY 2020.
Page 21. To ensure the reliable execution of CSP 2021, we set three enterprise priorities closely linked to our performance goals and launched full scale implementation in FY 2024. Growth strategy aims to maximize the potential of strategic brands. Bold ambition aims to increase pipeline value. Sustainable margin transformation aims for company-wide cost optimization. The following slides will explain the result of each.
Page 22, I will explain the result of maximizing the potential of strategic brands. In addition to PADCEV and XOSPATA, which were already on the market at the start of CSP 2021, we successfully launched VEOZAH, IZERVAY, and VYLOY during the period of CSP 2021, establishing a diverse high-margin portfolio of strategic brands. Furthermore, we obtained approvals for PADCEV as first-line treatment for MUC and for the additional indication of MIBC, which serve as the key growth drivers, thereby further strengthening our growth foundation. As a result, our strategic brands expanded robustly, achieving a remarkable growth of 10-fold over five years.
Since the majority of strategic brands are fully owned and are high margin brands, they have strongly elevated Astellas' overall revenue and profit growth during the CSP 2021 period. The solid track record we've built over the past five years has further increased the certainty of our future growth, where we carry this growth momentum forward into the next Corporate Strategic Plan.
On page 23, I will explain the increase of pipeline value. We accelerated the development of flagship programs in each primary focus area and achieved four POC from three assets. Furthermore, we strategically and systematically generated follow-on programs and incorporated external innovation based on our focus area approach, thereby expanding our pipeline. As a result, we have established a franchise in multiple therapeutic areas such as prostate cancer, claudin 18.2-targeted therapies, and retinal diseases, where we have cultivated strengths through the development and sales of main products, thereby building a foundation for sustainable growth.
Page 24, I will explain the outcome of the SMT. Since launching the SMT in FY 2024, we have achieved cumulative cost optimization of JPY 65 billion over two years. Furthermore, cost optimization measures for FY 2026 and 2027 have already been identified, and we are now at the stage of ensuring their reliable execution. We are fully on track to achieve total cost optimization target of JPY 150 billion. In addition, the SG&A ratio improved by a total of more than 5 percentage points over the two-year period from FY 2024 to 2025, and we are gaining clear traction toward improving profitability. When moving forward, we will continue to advance cost optimization through SMT to establish a highly profitable financial structure.
Page 25, I will explain the revenue and core OP growth over CSP 2021 period. Revenue expanded 1.7-fold over the five years, driven by the strong growth of strategic brands. Core OP expanded 2.2-fold over five years, driven not only by the revenue growth but also by significant contributions from cost optimization through SMT starting in FY 2024. The core OP margin also improved significantly.
Page 26. Today's key takeaways. Our strategic brands delivered exceptional growth, raising confidence for future expansion. Furthermore, we have established a robust pipeline and a built foundation towards post extended loss of exclusivity growth. Additionally, through SMT cost optimization, we have made significant progress toward a resilient cost structure. Over the five-year period of CSP 2021, we are now fully prepared to overcome the extended loss of exclusivity and to continue to grow. In our next corporate strategic plan, we aim to demonstrate how we will achieve sustainable growth by building on the foundation we have established to date.
At the end, I would like to remind you of the briefing session for CSP 2026. It will be held on May 26th, and we hope you will be able to attend. That concludes my presentation. Thank you for your attention.
That's all for our presentation. We now would like to entertain questions from the audience. If you have questions, please press the Raise Hand button at the bottom of your Zoom screen. If you are joining from your smartphone, please tap Details, then Raise Hand will be shown, so please press Raise Hand. I will name you one by one. If your name is called, please unmute yourself on your own screen, mention your name and affiliation, and ask questions so that as many people as possible can ask questions, each person can ask up to two questions.
Thank you very much for your understanding and cooperation. We'd like to take questions. First, Citigroup Securities, Mr. Yamaguchi, please.
Yamaguchi from Citigroup, can you hear me?
Yes, we can hear you. Thank you very much.
Hello. Thank you. Thank you very much. My first question is as follows: As you explained during the presentation, for strategic brands, in particular, you would share some forecast for some of the products, but not for strategic brands. So external parties cannot see the forecast. It may be seen as restricting, but what are you going to do about the individual trends of each products? The disclosure of individual product information is not going to happen. What's the reason why? Could you explain once again?
The results will be explained for each product as we have been doing up until now. In the process of the growth of new products, there are uncertainties for each product. There is an increase or decrease for individual products. Focusing on such a fluctuation is not very constructive in our view. Based on that, what kind of action we are going to take and how that's going to be reflected onto the actual results, that's something we want analysts and investors to see. This product is expected to have this much revenue or sales in this particular region. Rather than having such discussions, what we are hoping to discuss are the situation of five strategic brands as a whole.
In the mid to long term, we are going to capture the development and the growth of the products. It may not be the right expression, but you can demonstrate your capabilities, so I'm looking forward to future interaction.
Once again, you're on the in May, on the 26th at 4:00 P.M., you're going to explain the next CSP. You're not going to talk about individual products very much. Between 4:00 and 5:30 P.M., are you going to share the presentation materials on the same day or the previous day? If you change, how we can prepare?
After the closure of the market, we are planning preparing to disclose the documents after the close of the market, like at 3:00, like today.
Thank you very much.
Next, JP Morgan Securities, Mr. Wakao, please.
Wakao from JP Morgan speaking. Thank you very much. I have a question about XTANDI and the five strategic brands, the results in the fourth quarter, and also the outlook for the current fiscal year. As for XTANDI, you can just talk about the actual results. Fourth quarter was a little bit weak in the United States. I'd like to know why. Five strategic brands, PADCEV was doing very well. What's going to happen this year, particularly in MIBC? How we should look at the situation? I'd like to hear your view. IZERVAY as well, the plan was not achieved, but in principle, it's going to grow continuously in the current fiscal year. I'd like to know more details. Thank you very much.
Thank you. I summarize the comment briefly, and because Claus is here, the rest is going to be explained by him. As has been mentioned, XTANDI, in the first quarter, the business is a bit weak, and we did our own analysis, and of course, the countermeasures for that plan to be executed. As you know, for XTANDI, in 2027, January, in line with the IRA, the price is going to be revised. In the history of XTANDI, it's going to be the year of the reduction, and that impact was already explained within my presentation.
Just like you mentioned, in FY 2025, the track record is that PADCEV and VYLOY, monetary value-wise, their growth level is outstanding, and VYLOY that was just launched in the market, so growth rate is over our expectation. What is going to happen for in FY 2026, we are not going to share with the individual products, so situation, so I don't know if it is right to talk about it. However, for PADCEV, for their first line, other than United States, it's going to grow further and as the U.S. market as a trigger for MIBC market as well, we expect that the sales is going to contribute to it.
As of yet, as well, 2025 is a little bit of an interesting situation. However, in this couple of year, months, looking at the track record of that, time of period, still there is a room of the growth. That's why we didn't revise our sales forecast. It has to grow further. We are having such a very expectation. Claus, do you have any additional comment?
Yeah, maybe just briefly to the three brands you asked about, XTANDI, PADCEV, and IZERVAY. I think the fourth quarter is indeed a little bit weaker, but we see the entire market being weaker in the ARPI. I think it's probably a mix of a market effect and turbulent competitive and market dynamics for XTANDI in that particular quarter. We've grown very, very well over the year, and we've now reached the peak sales for XTANDI. I think that's a very strong contribution to our growth rate. Let me turn to PADCEV, because PADCEV, I think we need to distinguish between U.S. growth, where we have the EV-303, so the cisplatin-ineligible MIBC indication already approved.
On approval, as always with PADCEV, we see the market responding very, very quickly and uptake goes up. However, please let me also remind you that that uptake usually plateaus after about six months. We're expecting that also to happen. U.S. growth is very strong right now, but we do expect a plateau to come in end of Q1 or Q2. Whereas Europe and the other ex-U.S. countries do not have MIBC in any noticeable fashion in FY 2026. Here, we expect a strong growth to be driven by reimbursements coming through on the first line metastatic indication. You get a very different dynamic in the two parts of the world. Overall, I think PADCEV will continue its strong growth trajectory.
Now, let me talk about IZERVAY. You do remember about a year ago, when the foundation funding dried up, the entire market, the new patient starts for the entire market, both in geographic atrophy but also in wet AMD, went down significantly. It has affected sort of the base from which we have regrown. As Naoki said, we have regrown from that lower base since then, but we've done it in a very consistent and very successful fashion. It's about 11% quarter-on-quarter that we've grown since that rebasing. I also would like to draw the comparison to other products in the intravitreal space. If you look at, let's say, Eylea, Vabysmo, Syfovre, they've actually all decreased in sales.
Eylea by 27%, Vabysmo by 10%, Syfovre by 4%, and we actually have grown more than 30%. I think in a very difficult market environment, IZERVAY has really produced a very, very impressive performance of consistently growing from that lower base. We do expect that to continue as the complement inhibitor class also grows.
Thank you very much for the details. As a follow-up, MIBC has a good market penetration, but it could reach a plateau quickly. That's understandable. As for EV-304 to get the approval, a similar thing can happen. Is that factored in into the forecast? If the uptake is so fast, overall, there can be a further increase by PADCEV.
We do expect the 304 approval by the PDUFA date as stated previously. That would indeed then produce another uplift on PADCEV.
Thank you very much. My second question. In the past five years, XTANDI cliff is to be exceeded and you have a platform to increase your product. You have improved pipeline as well. I have a question to you. Large sized M&A, any possibility? How much leverage are you going to use? I think that's in the appendix, but in principle. According to the pipeline which is shared with us, you would exceed the XTANDI cliff to grow. Is that your assumption? Is my understanding correct? Depending on the status of the products under development, you may need an M&A deal. As a base case scenario, you would use your own pipeline to grow. Can I understand that way?
Thank you for your question. Up until now, as we said a few times by now, this is an illustrative XTANDI figure. XTANDI will decline, strategic products will increase. We would have programs from focus area approach to be added in a chart like this. In 2026, a peak is expected for sales. Then we have, during the course of CSP 2026, our revenue may decline and then, we go back to a growth trend once again.
Your view and our view may not be so different. If there's going to be a dip, a large M&A deal is going to be used to prevent the dip to minimize the dip or to make it flat. If that's your question, we're not going to do such an M&A. That's my response. This is the so-called rescue BD to rescue from the dip or decline. We have no intention to do such a thing because such a deal would have an increasing price because everybody wants such an asset or a transaction. After we get something, if there is a small room for us to get the value, it's not going to very good cash flow for deal. This is just the exchange for cash.
There aren't many elements to force us to do something like this. If we don't do a rescue a deal, then are we going to pause BD? You may interpret that way in an extreme fashion. As we have been doing before, our franchises and the existing primary focuses to be reinforced by technologies and attractive assets we are going to pursue such opportunities very actively. Everybody talks about M&A very easily, but in the world of pharma, sharing the risks with the owners, there are many ways to do so. Back-end licensing agreement is one way or milestone payments to be linked with regulatory outcome by doing so. A huge amount of payment is made at the beginning, but nothing happens. We can prevent such a situation. Of course, we are making such efforts.
Still, having said so, how attractive our pipeline is right now, because worst failures could occur. 2030 and beyond, the growth we want to achieve could not be envisioned. In that case, we should be able to use flexibility. Under Kitamura, we try to repay the debts as soon as possible. Gross leverage ratio EBITDA 1x up to 1.5x as we declared. We think we are already sufficiently within this range. If necessary, a large size BD can be done, because we have such extra financial capabilities. EBITDA is growing bigger than before, so the money we earn would be returned to shareholders partially.
Also, we'd like to make R&D investments for future growth. Various investments will be made by using such a money. For details on May 26, we will announce our CSP 2026. We will try to talk about our plan as much as possible, and you can ask further questions during that meeting. That's all the information I can share today.
Thank you very much. That's all. Thank you.
Next, UBS Securities. Seki , please.
Seki is my name. Thank you very much for your explanation. First question is about dividend. At this time, JPY 80 increased with the JPY 2 . In the past two times, the increase is every JPY 4 , but this time JPY 2 increase. I believe that you had a lot of discussions about this situation. I believe the discussion was quite difficult. You have JPY 4 , JPY 4, and this time JPY 2. I think that itself includes some message. Now about the CSP. This JPY 2 increase, what's your intention? What's the message?
Kitamura is going to explain.
Thank you for your question. I'm Kitamura, CFO. First of all, this dividend, as Okamura explained, investment for the growth and also return to the shareholders, those are continued. That is our policy for capital allocation. There is no change whatsoever on net. For dividend, a single, rather than single year performance, mid to long-term performance, cash flow forecast, against that or based upon that, the stable dividend is provided. That is our decision. JPY 2 per year and the performance was good, so dividend is increased. It's not something like that. We have a sustainable plan. This time to yen. In the past, for yen increase.
Well, rather than talking about a single year, again, mid to long term perspective is necessary and based upon that, we decided to increase to yen. For details, around the end of May, when we make a presentation at CSP, next CSP, we would like to give further explanation. Currently, margin is good. Free cash flow is good. Financial performance is strong. Just like Okamura mentioned, when we do something and we are fully prepared, so we'd like to be flexible to think about capital allocation. That's all.
Thank you very much. The second question is about pipeline. Last week, AACR took place and KRAS competitors' data, Revolution Medicines, good data was shared. Not only data, but also oh five five, the non-clinical data was also good. Based upon such data, your franchise, KRAS project, your ways to look at is not different. The area is still the therapeutic area worth investing.
I am going to make answer first of all, and followed by Taniguchi. We consider that KRAS is quite an important target. Their success means that KRAS is definitely a target that we should more focus on, so their success is proving it. The difference of mechanism of action. But first of all, that data is a very early phase. So, the benefit due to the difference of mechanism of action is available in our product.
At the very end, when the late phase data becomes available, that is the time we can say which wins or lose. I think as has been mentioned, thanks to their success, that became our confidence of targeting the KRAS. Thank you.
Taniguchi speaking. As has been explained by Okamura, Revolution Medicines data. PARP inhibitor by Revolution, and that data is disclosed. This is really good data. We have the KRAS target project. The KRAS itself is quite promising. That's what we've learned, including PDAC, NSCLC. KRAS is suggested to be really good target for the treatment. Setidegrasib that we have. The first line of PDAC phase III has just started regarding this indication. We are a bit ahead compared to Revolution Medicines.
Our KRAS G12V targeting setidegrasib , not only efficacy, but safety as well. The preferable result is available, so it is easier to combine with chemotherapy that is a current standard of medicine.
In the case of PDAC, in severe patients, it's difficult to administer the drugs orally. IV infusion setidegrasib can be used for such patients as well. That's our expectation. As for the data, we disclosed some of the data already. Based on our data as well, KRAS target is going to be important into the future for important PDAC and lung cancer as targets. That's all from me. Thank you very much.
Thank you very much.
Next, Goldman Sachs Securities, Mr. Ueda, please.
I'm Ueda from Goldman Sachs. My first question, your initiatives in SMT, I'd like to know more details. For the JPY 1 billion reduction is going to be incorporated into your plan for the current fiscal year. What kind of items are going to be the major ones? In 2027, your measures was shown here. Some are already identified, so what you're planning to do? Specifically, if there is there anything you have already decided? What about the certainty of these measures to be implemented?
As we said, we are going to do something which is already identified, so we will just work on it. Still, in areas like this, if we do something like this, we may not be able to realize the effect as we planned, or it may take more time as we were planning. The value could be diluted, so there can be such risks. Now that everything is already identified, so we just need to do, and work on that? No. We have to pursue further opportunities for SMT continuously.
Kitamura-san can talk about the further details as far as we can share.
In 2026, we are expecting additional JPY 40 billion. By FY 2025, we work on various measures, and we'd like to harvest the benefits there. Specifically, as you know, we have global operations. In order to increase the productivity in FY 2025, we made huge investments creating new bases to concentrate our operations there to achieve scale and implemented automation. We took such a major action, and we'd like to harvest the effectiveness there, so it will generate a certain level of huge benefits. Creating necessary capabilities in-house, that's also one of the measures we are working on. Capabilities integration, including integration with vendors, are also ongoing.
Sales promotion related back office or material development, and there can be a lot of synergy, so we are going to harvest the results. Those are the main things we are considering for FY 2026. What about 2027? We will explain in the future. SMT is not a single year initiative, but it's a multi-year initiative. In the first year, we worked on lower hanging fruits, easier to realize, to prepare for the mid to longer term in 2027. That is going to be the final year. Actions which require a longer time, and we are going to harvest the results from longer term projects such as supply chain. Larger scale projects with longer lead time would be realized in 2027. That's what we are expecting.
Understood. Thank you very much. My second question. In the United States, I'd like to ask you about the business environment in the States. Pharmaceutical duties and MFN. Do you have anything you can share in terms of the negotiation with U.S. government and also MFN and the tariff? How do you see the potential risks in your plan? Is that going to be fully manageable in your plan? I'd like to ask you this question. Thank you.
Thank you for your question. Needless to say, receiving a letter and based on that, negotiation with the authorities by some companies, you know, those company names and what was the result. We heard such a rumor, and the first round seems to come to an end. We haven't received a letter from the U.S. government, but still we try to open a channel to discuss with the government authorities.
Looking at the components of the agreement, we can learn what kind of factors are incorporated and for each factor, what can we do, what we cannot do. Those are, of course, we've already considered and discussed. Tariff or MFN, there are some rumors or stories are ongoing, but we don't know any specifics. We have prepared ourselves, but those are not really quantified so that it could be incorporated into the Corporate Strategic Plan. Of course, we do a certain level of low-risk analysis. We have coming products from a focus area approach, and once they come to the market, what kind of price environment we will face around that time. For that purpose, we have to have a very sensitive antenna.
From marketing access perspective, what can we do and what kind of preparation we need to do, those are all under the consideration. This might be the repetition, but regulations and rules, those are not something we can set by ourselves. The rules and regulations are decided by somebody else, and we basically have to follow that. In order to follow that, we do whatever we can do in a maximum way, and the rules are likely to be changed. If there are some countermeasures conceivable, then we would do so. That's probably the only way we can do for this type of issue. Is this a big problem? Yes, it is likely to become a big problem. Nothing can be started just move or make action only with partial information.
Because we have patients, the patients are around the world. We cannot make a decision, we think about only U.S. patients and not ignoring other countries' patients. We always would like to think about delivering a value in a uniform manner throughout the world. I think that's probably what we can do. Did I answer your question?
Thank you very much. That's all from me.
Thank you very much. Next, Nomura Securities, Matsubara-san, please.
Matsubara from Nomura speaking. Thank you for the explanation. I have two questions as well. The first one is a question related, Ueda-san. So follow-up question about SMT. You might say that please wait up until CSP 2026 announcement. There are some areas you can do the cost reduction. In FY 2027 afterwards, cost reduction through SMT is possible to be expected.
Kitamura-san?
Thank you very much. Partly, this is personal opinion. First of all, cost optimization and journey of that is going to be continued. If you were to ask me, have you completed that? Well, that's one way to look at it. At the same time, technology is been advancing day by day. As my personal perspective, cost optimization never ends. However, cost cut is not only the way, not only pursuing the numbers just in front of us. What is important is to continue to deal with that from mid to long term perspective. For that purpose, you need a certain mechanism. When you say cost, you tend to talk about only input, but maximizing output is also important. The bigger value is going to be delivered to the patients as early as possible.
With doing that, we need to increase the productivity. Your question, are we going to do this 2027, FY 2027 afterwards? Of course, we will do that. What about approaches? Well, we have a conventional approaches that is based upon the sustainable margin transformation or SMT with a four-year plan and execute those plan and the PDCA is turned around. It will continue the same thing? Well, I myself, this approach so has to be evolved. Rather than doing the same type of SMT for the next four years, rather we are going to accelerate that so that we can boldly work on this. Such details are going to be further explained, possible to be explained at the time of CSP presentation. Thank you.
Then I'm looking forward to that. My second question is about XOSPATA. In partial study, primary endpoint was not achieved. Peak sales assumption is JPY 100 billion-JPY 200 billion, no change. What's your view on the peak sales?
Thank you for your question. Unfortunately, primary endpoint was not met. Regarding this indication, for us, in principle, we are not going to pursue this indication globally anymore. As for the change in the sales forecast and what is going to be happening into the future, Claus Zieler is going to add. Zieler-san.
Yeah. I mean, XOSPATA is on a stable growth path. It's not a very fast growth path, but it's a stable growth path. We do expect that continue. Even in the PASHA study, there are some elements which are actually quite interesting for doctors to study. Our reputation for XOSPATA or gilteritinib as a FLT3 inhibitor is very much intact, even with a lot of first line competition coming into this market. We expect this agent to continue on that, you know, slow single digit growth path that we've had in the past.
For the future, in subgroup with gene mutations, administering this to those patients or in combination with chemotherapy, primary endpoint was not met. But this XOSPATA could be utilized in different types of patients. Is my understanding correct?
Taniguchi-san, anything to add from you?
Okay. May I? As for XOSPATA PASHA study, primary endpoint was not met, and analysis is now underway. Of course, subgroup analysis are included as well. From various angles, analysis is being performed. As soon as we get the results, we're hoping to share with you and in which segments we are going to go for or not going for, we are hoping to have such an opportunity so that we can explain.
Okay, understood. Thank you very much.
Thank you very much. Next, Morgan Stanley MUFG Securities, Mr. Muraoka, please.
Thank you very much. Morgan Stanley, Muraoka speaking. Most of the topics already covered, XTANDI. Quarterly results or quarterly figures, hopefully we've explained. Today it doesn't make sense to talk about the details of each product, but my question is, according to your forecast for FY 2026, in the initial nine months it may flat or increase. In the fourth quarter, there can be a big decrease year-on-year. Is that your image, perhaps? If you can share such an image, I'd like to hear. Thank you.
Thank you very much. First of all, XTANDI as a whole. Discussing the figures for XTANDI as a whole, we have, it can be dangerous, so we have to discuss U.S. and ex-U.S. separately. As for U.S., as you said, in the fourth quarter, IRA will kick in. How much is a different question, but it's clear that it's going to be in the negative column. In other countries outside of the United States, the pace of growth up until now is going to slow, needless to say, because more than 10 years have passed since the launch. If it's going to grow at the same pace as before, no, that's not going to happen. We have EMBARK data and other data we can use, so we still have room in the market or where we can grow or we should grow. That's my basic principle.
Claus, anything to add?
No, only to add that, of course, ex-U.S., the patent, the exclusivity is much longer, 28 in Europe, but in Japan, in Australia, in Russia, and some other markets, we have quite a long patent life. This is not just one, you know, patent exclusivity that we lose. It's really country by country over many, many years, about over four years in total. That's the only thing I wanted to add.
Thank you very much. One more question to you. OP margin, 30% has been discussed quite often by now. I may ask you a question about CSP, so I hesitate a bit, but 30% Core Operating Profit margin is something you are very particular about in pursuing? If that's the case, how you're going to work on this? It's difficult to imagine because of the cliff, how you're going to achieve, where are you going to achieve this? This can be a decline, and then you go up again. What's your philosophy, and how much you want to be particular about this?
In a word, please, looking forward to May 26th, but I would like to make some comment here just a little bit before that day. I think in the past I mentioned about it. We are this size of a pharmaceutical company, and with innovation, we try to contribute to the society. This is our style. As such biopharma company, cost of goods to 25%, SG&A at 25%, and cost is reduced a little bit, and SG&A might be increased a little bit, and vice versa might happen. Anyhow, adding up these two, 50% is the margin level that we would like to manage. Before the deduction of R&D, the profit is 50%. Out of that, the 20% of sales is allocated to R&D because that leads to the continuous delivery of innovation.
That's my way of thinking. Based upon that, we come up with a number of 30%. The sales is reduced, so you cannot do in that way. I understand you would say in that way, but further details are going to be described on May 26.
Understood. Thank you very much. One brief question. Mirabegron, the actual January to March, $180 million. It's increased to that extent. What's the background of that? I just got a little bit confused.
I can explain about this, but Kitamura can explain in a thorough manner. First of all, you asked me if Betmiga with the generic companies will come to the settlement. In line with that, other settlements took place, and partially the royalty aspects are agreed, including the royalty as well in the fourth quarter and afterwards, some adjustment is applied. That was the situation, and that will continue. Please look at the number of mirabegron as that as a precondition. Some others one time factor also added that leads to the increase in the fourth quarter, rather than one time.
Precisely speaking, the transaction not included until the third quarter is now included and agreed patent period. During that period, this will continue. That's the way to look at. 26 Betmiga number is disclosed, and as you know, the number is not that low. That's because of the inclusion of royalty adjustment.
Understood. Thank you very much.
Thank you.
Next, Macquarie Capital Securities, Tony Ren-san, please.
Okay, perfect. Yeah, thank you for taking my questions. I have two. The first one is about your intangible assets on slide number 35. You commented that you had some impairments for your gene therapy. It appears to me that the value for some very successful products such as VYLOY and IZERVAY have also decreased a little bit. Could you comment? Is it because of impairment or is it because of normal amortization? Yeah, that's my first question.
Thank you for your question. I think the intangible asset, you know, is a combination of amortization, especially that is more like, you know, moved to the sales right in the market. You know, a product-related intangible asset is now classified from the in-process R&D to the sales right assets. Sales right, yes, you know, they will be amortized over years. It's a kind of very healthy transactions. Now, the impairment loss and sometimes bigger in the in-process R&D because the in-process R&D amount is still as it is and up until the product will qualify to the market.
If we fail to qualify the market, we need to, you know, write off those, you know, the asset, you know, 100%. We didn't have, you know. We did have, you know, the impairment loss recorded in AT132. That's the gene therapy in a product asset, but we have the new asset, you know, in the clinical trial. So we shift our focus from AT132 to, you know, the ASP2957.
57.
57. Thank you. As Naoki already mentioned. I see, you know, the different move in intangible asset, but overall, you know, this time we make the progress so that, you know, we shift the focus from one project to new project. Also the, you know, the amortization start and move as we planned, because product is in market. I hope I answer your questions.
Yes, it's very clear. Thank you very much, Kitamura-san. My second question is about your clinical collaboration partner, Kelonia. So obviously, Eli Lilly acquired Kelonia. You have been cooperating with Kelonia over CAR- T, in vivo CAR- T cell therapy since early 2024, so it's about two years now. Have you guys considered acquiring Kelonia? Was it because you did not want to compete against Eli Lilly, or was it because CAR- T or blood cancer is not part of your key priorities? How does your collaboration with Kelonia change after the Eli Lilly acquisition?
Thank you for the question. Probably that question should be answered in a very scientific aspect. I would like Tadaaki to answer those.
Thank you. Our Kelonia collaboration actually have one, you know, this, the project. You know, as you mentioned that in vivo CAR- T platform, we work together in a preclinical, you know, the program. You know, our decision is that we're not pursuing that, you know, project moving forward to the further. We, you know, terminated that project. That's where we are now. I don't think we have any impact that, you know, Eli Lilly is going to acquire Kelonia. But of course, we have still, you know, connection with them, but, you know, we don't have any specific project working with them now.
Okay. Did you guys have the discussion over possibly acquiring Kelonia?
No. Obviously, you know, we have no intention to do that.
Okay. Thank you very much.
Thank you very much.
Thank you very much. Next, Sanford C. Bernstein, Ms. Sogi, please.
Thank you very much. First, about KRAS, I have a question to you. Revolution Medicines, pan-KRAS, pan-RAS daraxonrasib. Phase III results were announced for a second line plus for PDAC. As for the first line, they have a PDAC program, a monotherapy, a combination. Your setidegrasib KRAS G12D and competitor is going to be earlier. Because of the pan-RAS for Revolution Medicines, this one may be more effective or similarly effective. KRAS G12D specific target is your product. So this can be a disadvantage for your product. Pan-RAS versus KRAS G12D specific. In terms of efficacy, what kind of scenario are you hoping to see?
It's too early to say specifics to explain the differences, but Taniguchi is going to explain as much as he can.
Thank you very much for your question. Revolution Medicines pan-RAS. It's pan-RAS, so it's not just limited to KRAS, but RAS inhibitor, more broadly. Because of this, the target patient population is broader according to understanding. Maybe because of that, we don't know clearly, but I saw their data, for example, of skin-related adverse events and GI-related adverse events seem to be high in the incidence according to our impression. When this is brought to the clinic, what's going to happen? Regarding our setidegrasib, not just efficacy, but safety, relatively speaking, is also favorable according to understanding.
We just started PDAC first-line study. Chemotherapy combination is going to be the main regimen in the study we are planning to execute. When I discuss with the doctors, the opinions might be different from doctor to doctor, but in the targeted population by the drug and a drug with a broader coverage, which one to use first? As far as we have heard from the doctors, more targeted product is the one they would like to use. Such a response is more frequent, so once the phase I data is going to be available, they would decide.
One more question. Thank you. Actually, is the ASP2998 Trop-2 targeting iAGC that is a new type of ADC? Regarding the linker, within the cancer cells, selectively it is cleaved or outside, especially regarding STING agonist. Outside of the cancer cells when it's released, it comes into the cancer cells for the action. Is it already confirmed? Also, these linkers are cleaved only within the cancer cells.
For that, I think there has to be their patient selection strategy considering their Trop-2 ADC development so far. With regard, what is your strategy? Taniguchi is going to explain.
Thank you very much. That is a very scientific question. ASP2998, as has been mentioned, STING agonist and also Topo- 1 are used as dual payload targeting Trop-2. This is such ADC. If it is cleaved around the target, the design is in that way, according to my understanding. One of the characteristics of this drug is Trop-2 target, not only ADC, but because of the existence of STING, the tumor or tumor microenvironment, then activity is promoted to enhance the anti-tumor action. That is the concept of the design.
Looking at the preclinical data, though compared to the conventional ADC targeting, Trop, efficacy is superior. That is where we have higher expectation. What is the focus of STING? If we learn about that, we can share that with you. So far, I don't remember the data. I take it back. I bring it back, and if I identify some information, I would like to share that.
Thank you very much.
There are some more waiting for asking questions, but because of the time, next is the last question. Nikkei newspaper, Ozaki-san, please.
Ozaki from Nikkei newspaper. Can you hear me?
Yes. Please.
Thank you. This might be a little bit different question. The current Middle East situation, I just wonder if that has a impact onto your business. Not the previous time, but for this time. Does it have any impact?
Thank you for your question. In the Middle East, the countries where we have footprint and having operations, of course, the employee safety is a priority. At the same time, it's the area of the war. Because it's the area of war, there are patients who are still requiring our products, so we definitely would like to make sure the delivery of the products to them. The Strait of Hormuz is now closed, and because of that, the various type of the oil-related materials are a bit delayed in terms of the delivery. With that impact perspective, so far we can say that there is no big impact on us and we are not thinking that we'll have a bigger impact.
Our product is one of the component of the all of the medicine or healthcare. As has been mentioned, if there are some more problems that happen for the materials, for example, the infusion bag issue or cylinder for the injections. If there were some problems in terms of the supply of those, there might be a question or problems incurred. We always would like to continue to pay attention. As has been mentioned, with the topic of the U.S. administration, we are not going to be reactive for each individual events.
Of course, we do our preparation. We do not consider that the business is going to be of a sudden better or the worse, just one thing. We would like to be prepared all the time.
Understood. Thank you very much.
Thank you for many questions. Time has come. With this, we'd like to close today's meeting here. Thank you very much for joining us once again.