Astellas Pharma Inc

Thank you very much for joining our FY2024 Financial Results Announcement meeting by Astellas Pharma Inc. out of a very busy schedule today. I'm delighted to serve as a moderator. I'm Ikeda, Chief Communications and IR Officer. Thank you for your time. Today, after presentation, we will move on to Q&A session. Presentation will be made based on the material posted on our website under the IR meeting section. We have simultaneous translation between Japanese and English, including Kyonei. We cannot guarantee the accuracy of the translation. Thank you for your understanding. You can choose the language from the menu on the Zoom webinar screen. If you select the original language, you can listen to the original sound without going through the translation. Disclaimer for today. This material or presentation by representatives for the company and their answers and statement in the Q&A session includes forward-looking statements based on assumptions and beliefs in light of 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 and development, but this information is not intended to make any representations or advertisements regarding the efficacy or effectiveness of these preparations, promote unapproved use in any fashion, or provide medical advice of any kind. Let me introduce the participants. Naoki Okamura, Representative Director, President, and CEO. Chief Research and Development Officer, Tadaaki Taniguchi. Chief Commercial and Medical Affairs Officer, Klaus Zieder. And Chief Financial Officer, Atsushi Kitamura. We have four executives. We would like to have a presentation. Okamura-san, please. Ikeda-san, thank you very much. Hello, everyone. I'm Naoki Okamura from Astellas Pharma Inc. Thank you very much for joining our FI2024 Financial Results Announcement Meeting out of your very busy schedule today. This is a cautionary statement regarding forward-looking information. As this was explained by Ikeda earlier, I'm not going to read this page. Page 3 is the agenda for today. Starting from the next page, I will explain these topics in this order. On page 4, I will give you highlights of FI 2024 financial results. In FI 2024, revenue and core operating profit reached a record high since the establishment of Astellas. Revenue increased significantly year-on-year by 19%. Sales of strategic brands as a whole expanded to over 340 billion yen in total, with growth of about 180 billion yen year-on-year. As for SG&A expenses, excluding U.S. extended co-promotion fees, driven by Sustainable Margin Transformation, or SMT, our initiatives to pursue company-wide cost optimization, we achieved our cost optimization target of about 40 billion yen. and SG&A ratio improved by 3.1 percentage points year-on-year. Co-operating profit increased significantly year-on-year by 42%, driven by the growth of strategic brands as well as the continuation of SMT cost optimization. Co-operating profit margin went up by 3.3 percentage points year-on-year to reach 20.5%. On page 5, I will explain FI 2020 for financial results. Revenue reached 1,912.3 billion yen, up by 19.2% year-on-year. Co-operating profit rose to 392.4 billion yen, up by 41.7% year-on-year. Both revenue and co-operating profit exceeded our full-year forecast. The Forex impact is shown on the right-hand side of the table. There was a positive impact on revenue by 68.1 billion yen and on co-operating profit by 15.1 billion yen. The bottom half of this page shows our full basis results. In the right bottom of the table, we included other expenses booked in FY2024. This was explained when we announced the third quarter year-to-date results, so I will skip the details today. In the end, operating profit was 41 billion yen, up by 68.8% year-on-year. Profit increased to 50.7 billion yen, up by 197.7% year-on-year. On page 6, I will explain EFI 2024 financial results over main products. Sales of strategic brands of future growth drivers, namely Patsev, Isovay, Vioza, Viroi, and Zospata, more than doubled to approach 340 billion yen in total, with a growth of about 180 billion yen, or 110% in a year. Due to high profitability of these brands, they not just contributed to revenue, but also played a major role in driving the overall profit growth on a consolidated basis as well. Let me also explain individual strategic brands. I will explain the details of PADSEV, ISAVE, and VILOI later in FY 2025 Outlook section, including our sales forecast and progress status. Global sales of PatSafe increased to 164.1 billion yen, up by 78.7 billion yen, or 92% year-on-year, realizing nearly two-fold growth. Sales expanded in all regions where it's launched. The number of first-line metastatic ulcerative cancer approval countries has been increasing steadily, with rapid market penetration after approval. Isovay was launched in the United States just about one and a half years ago, but its sales expanded to 58.3 billion yen. Isovay was launched about six months later than the competitive product, but it has established its positioning as the first-line treatment for new patient starts since FY2024 second quarter. After November last year, its growth temporarily slowed down Due to the impact of CRL, complete response letter for label update submission, but in February, the label update was approved, and we have been able to confirm signs of the prescription expansion trend recovery since. Global sales of Vioza expanded to 33.8 billion yen. In addition to its growth in the United States, the number of countries where it's launched in the established and international markets has steadily expanded, contributing to sales growth. Globally, Vioza has already been approved in 43 countries and launched in 24 countries. As for Viroi, starting with the launch in Japan in June last year, the number of approval countries has increased steadily. Global sales reached 12.2 billion yen. Higher-than-expected rates of clothing 18.2 testing drove strong performance, with uptake exceeding expectations. Regarding Zospata, global sales increased to 68 billion yen, up by 12.9 billion yen, or 23% a year. Sales expanded steadily in all regions where it's marketed. Zospata is maintaining a high market share in the current indication of relapsed or reflectory AML. As for Xtendi, global sales increased to 912.3 billion yen, up by 161.8 billion yen, or 22% year-on-year. In all markets led by the United States, sales expanded. We believe global sales are reaching projected peak level. Impact from U.S. Medicare Part D redesign was mostly within our assumptions. Sales landed in line with our full-year forecast. On page 7, let me explain FI2024 SMT achievements. Through SMT initiatives, we achieved cost optimization target of ¥40 billion in FI2024. As a result, SG&A ratio excluding U.S. extended co-promotion fees improved to 30.9% down by 3.1 percentage points year-on-year. On the left side of this page, you can find our specific initiatives towards cost optimization and the achievements shown in four categories. First, in order to build critical in-house capability to reduce outsourcing, we promoted in-house clinical trials, etc., which were previously outsourced. This led to the optimization of about 5 billion yen a year. Number two, as for further efficiency of global operations, we made progress mainly in the use of digital and AI tools, with which we enhanced company-wide efficiency and optimized costs by about 6 billion yen a year. Third, In order to optimize selling expenses with ROI focus, we achieved cost optimization of about 27 billion yen in total. This includes 15 billion yen cost optimization by making progress in the global organization restructuring, about 10 billion yen by reducing mature products-related expenses, and about 2 billion yen by sharing sales promotion materials globally. In addition, we will promote continuous company-wide cost optimization as well. We were able to allocate these resources generated by SMT to growth investments for strategic brands and primary focus. SMT is a source of future investments, and we will continue to work on this in FI 2025 and beyond. We're expecting 120 to 150 billion yen recurring annual benefit in FI 2027. We will continue to promote each of these initiatives and ensure cost management with disciplines. On page 8, I will explain core operating profit growth drivers in FI 2024. FY2024 core operating profit increased significantly, up by ¥115.5 billion year-on-year. This graph shows year-on-year comparison of main factors affecting core operating profit shown on the horizontal axis. Starting from the left, expansion of highly profitable strategic brands made a contribution to profit growth the most. Next. Expansion of U.S. extended sales, shown in a yellow bar, also contributed. Also, half of the U.S. sales is booked as co-promotion fee, so all the sales growth has not necessarily been directly linked to profit contribution. Next, a bar in blue shows cost reduction and growth investments. Part of the resources generated by SMT cost optimization were allocated to growth investments for strategic brands and primary focus. As others, there was some impact from U.S. mirror background generics. Cooperating profit in the end reached 394.2 billion yen. Cooperating profit margin went up by 3.3 percentage points to 20.5%. From here, I will give you FI2024 pipeline update. On page 10, I will explain May brand's key events achieved in FY2024. Updates since the last financial results announcement are shown in blue. For ISAVAY, we obtained a label update approval in the United States in February. Restriction on the duration of dosing was lifted, enabling dosing of ISAVAY beyond 12 months. Also in Japan, based on the results of overseas clinical studies, including other data, we filed a submission by using the conditional approval system. As other updates, for PADSEF, we presented EV302 study follow-up data in first-line metastatic urothelial cancer at ASCO-GU in February. The updated data is included on page 42 and 43 in the appendix. With regards to Vioza, for application of approval in China, we started phase 2 study to evaluate efficacy and safety with 45 mg, which is the same as the approved dose in the United States and Europe. We achieved first subject first treatment in February. In FY2054, we achieved label, indication, and geographic expansion for ISFA, PADSF, and Viroi, our important growth drivers, and were able to make substantial progress towards product value maximization. On page 11 and 12, I've explained the update for ASP3082 and 8845, which have made particular progress in the last three months among focus area approach programs. The current status of each of the other programs is summarized on page 34 in the appendix. First, I've explained the progress of ASP3082, the flagship program of primary focus targeted protein degradation. SP30A2 is a protein degrader targeting KRAS G12D mutant. KRAS G12D mutation is seen at a high rate in tumors such as PDAC, pancreatic ductal adenocarcinoma, NSCLC, non-small cell lung cancer, and CRC, colorectal cancer. As a recent major progress, we achieved POC in PDAC based on second- and third-line data from Phase I data. This is the first POC achieved from primary focus, and we are very pleased to have been able to achieve an extremely important milestone. Based on these results, discussion is ongoing on how to proceed from now towards early implementation of a registrational study in PDAC. We will let you know a specific plan once we make a decision. In Phase 1 study, assessment in other cohorts is also ongoing in parallel. In PDAC, we assess in combination with chemotherapy in the first-line settings as well. In NSCLC, assessment is ongoing in the second-line settings and beyond. POC judgment is anticipated for the first half of FI 2025. Also, in CRC, assessment is ongoing in the second-line settings and beyond. POC judgment is anticipated for the second half of FI 2025. As for additional data presentation, we are aiming for the second half of FI 2025 once we decide on the timing we will let you know. With the achievement of POC this time, we are increasingly confident not only about the probability of success of ASP3082 individually, but also about the potential of TPD, targeted protein degradation, as a platform. We are hoping that TPD will be an effective means to overcome limitations of traditional small molecules and address undruggable targets. Going forward, in addition to SB3082, we will further accelerate research and development of follow-on programs as well. PAM KRAS Degrader targeting various KRAS mutants is in the IND preparation stage. We are aiming to start a clinical study within FI 2025. Also, we are conducting research targeting non-KRAS undruggable cancer-related proteins as well. We will actively combine internal capabilities with external collaborations and also work on the creation of new generation of potential protein degraders. On page 12, I will explain AT845, a flagship program for primary focus genetic regulation. AT845 is a recombinant AAV8 designed to specifically and continuously express HGAA, human acid alpha glucosidase genes in muscle. It's under development for Pompe disease. Pompe disease is a rare disease caused by GAA gene mutation with progressive muscle weakness and respiratory failure as main symptoms. Currently, as a standard of care, ERT enzyme replacement therapy is being used to administer deficient GAA enzyme formulations. ERT has various challenges, such as the need for chronic repeated infusions once every two weeks, secondary disease progression after two to three years on ERT, and substantial economic burden associated with hospital visits and drug infusions. To address these challenges, gene therapy with AT845 is expected to offer long-term improvement of disease conditions with a single dosing. At present, Phase 1-2 Fortis study is ongoing. We presented follow-up data on six participants at a congress in February. Participants are patients with late-onset Pompe disease receiving treatment with ERT. They can choose to discontinue ERT after AT845 administration. 5 out of the 6 participants in the study assessment chose to discontinue ERT. As is shown in the right diagram, we confirmed that even after ERT discontinuation, physical function endpoints such as forced vital capacity and 6-minute walk test have been maintained over 1 to 3 years, approximately. In addition, RMAT, Regenerative Medicine Advanced Therapy designation was granted by FDA in February. FDA grants RMAT designation if a regenerative medicine product demonstrates with preliminary clinical evidence the possibility to be able to meet unmet medical needs in serious diseases. If designated, opportunities for priority review and accelerated approval will be offered. For this study completed, the enrollment of all participants towards POC judgment in the second half of 2025 we are making progress in line with our plan. From here, I will explain FI 2025 outlook.

Page 14. Before explaining the outlook of FY25, I would like to explain the new organization launched on April 1st. The new structure is not based on original function, but rather on a patient access that will allow us to move forward with end-to-end activities from the early research stages through to marketing and lifecycle management. These roles are served by value creation, value in capital, value delivery, and value enablement. Value creation integrates the divisions of research development and primary focus leads and plays a role as an innovation engine to create value for patients. Taniguchi, who is here today, will serve as the function of overseeing this as the Chief Research and Development Officer. Baidu Delivery integrates commercial and medical affairs divisions while maintaining the independence of each function and aims to deliver value to patients through industry-leading customer engagement. The Chief Commercial and Medical Affairs Officer, Klaus, who is here today, will oversee this. As value enablement, various specialized functions such as corporate and manufacturing will work closely with value creation and value delivery to support activities along the patient axis. NFY 25 under this structure will further strengthen our agile and cross-functional operations and quickly and efficiently promote projects, brands, and other assets. On page 15, I will explain the outlook for FY 2025. We expect continued strong momentum in our strategic brands from FY 2024, driving over revenue and profit growth. In addition, we expect multiple data readouts from studies for life cycle management. In the focus area approach, we expect further POC judgment following ASP 3082. We focused a revenue increase in FY 2025 due to the expansion of our strategic brands. Underlying growth excluding negative forex impact is expanded to be 7%. SG&A expenses are expected to improve by 1.0 percentage point as we continue cost optimization through SMT. For R&D expenses, the investment will be expanded and primarily focused with achieved POC. Core P is focused to increase. Underlying growth excluding Forex impact will be double-digit growth of 11%. As for shareholder return, we are focusing dividend per share of 78 yen and increase of 4 yen. In anticipation of future profit growth, we focus dividend increase of 4 yen just like previous year. On page 16, I explain our forecast for main brands for FY 2025. We expect continued robust growth in our strategic brands in FY 2025 and a forecast of all sales of 470 billion yen and increase of 133.6 billion yen or 40% year-on-year. In underlying growth excluding forex impact, sales will increase by 50% to the level close to 500 billion yen year-on-year. In particular, we expect the ISABE, POTSEF, and Availoy to drive growth, and the details of these three products are explained in the subsequent slides. Our focus for Part CEP for FY 2025 is 200 billion yen, an increase of 35.9 billion yen or 22% year-on-year, and we expect strong and continuous growth. As of today, it is focused at 105 billion yen, a significant increase of 46.7 billion yen or 80% year-on-year. Following the U.S. level update, there are signs of an upward trend, and we expect strong growth in the future. Vioza is expected to make a steady global growth with a forecast of 50 billion yen, an increase of 16.2 billion yen, or 48% a year. In the U.S. and other launched markets, we anticipate the number of launched countries will increase in establishing international markets, which are expected to make a sales contribution. Vilo is focusing significant sales growth of 40 billion yen a year, an increase of 27.8 billion yen. We expect expansion in the U.S. and Japan, as well as post-launch sales contribution in China. So SPDR is expected to grow to 75 billion yen, an increase of 7 billion yen or 10% year-on-year, and we anticipate stable and continued growth in existing indications. Future growth drivers include additional indications for newly diagnosed AML, acute myeloid leukemia, for which we expect to receive top-line results in the first half of FY2026 and expect sales contribution after approval. Finally, for Xtendi, our FY2025 focus is 868.5% decrease year-on-year. In the U.S., although the negative impact of the Medicare Party redesign is expected, our outlook is to partially be offset by the volume increase due to improved access through a reduced patient out-of-pocket payment, resulting in only a significant, a slight, rather, slight decrease on a dollar basis. On the other hand, we expect continued growth in markets outside the U.S., and this growth will offset the negative impact in the U.S. Thus, on an underlying basis, excluding the Forex impact, global sales will be at a similar level as in FY24. Page 17, Business Update and Outlook for Part 7 of ILOI. First, Part 7 is expected to reach the 200 billion yen. The first-line MUC continues to be the largest growth driver, with first-line approved countries expanding to 21 as of April. And we anticipate further approval and reimbursement progress in FY 2025. All regions will contribute to sales expansion, especially Japan, China, and the international market are expected to scale toward impactful sales level. For the U.S., the growth is expected to be moderate in FY 2025 compared to other regions, reflecting already high first-line market share close to 55%. Growth opportunities in FY2026 and beyond include an additional indication for MIBC muscle invasive bladder cancer. We expect the readout from the interim analysis by the end of this year, and if the results are favorable, we will proceed to NDA submission. Once approved, we expect that it will help APARSEP grow further. Next, by Loy. We expect significant sales growth with further growth in the U.S. and Japan and contributions of from the expansion of launch countries. Since its launch in Japan last June, the number of approved countries has expanded to 43, and 15 of which the product was already launched. The regional expansion has been extremely successful so far, and a further increase of launched countries will be expected in FY25. In China, which has a large gastric cancer market, a launch is anticipated in the first quarter and we are expecting post-launch sales contribution. We are working to increase the testing rate of gloating 18.2 globally to expand market share. And Biolo is expected to be a key growth driver for sales expansion with an expectation of its full-scale contribution to sales. Page 18, Eyes of a Business Update and Outlook. In dollar basis, representing underlying growth, the FY25 forecast is $750 million, an increase of 96% year-on-year, nearly doubling. In FY2024, there was a temporary demand slowdown from November of last year to February of this year due to the impact of the CRL or Complete Response Letter. But since much after the revision, the trend has returned upward. Azaveh is already widely adapted by retinal treatment setting, and it has established itself as the first line in newly diagnosed GA, geographic atrophy. And after temporary decline, a new patient shared to the low 50% range last December due to the CLL, but it recovered to about 60% in February. Currently, more than 2,000 retina counts have adopted the drug, and more than 50,000 patients have been treated with Azave since its launch. The post-marketing safety profile remains consistent with the clinical trial results and has been well-received by physicians. In addition, we are beginning to see signs of improved diagnosis and treatment rates as a result of our DTC efforts, and we expect further market expansion in FY 2025. Although FY 2025 has just begun, we believe we are off to a good start for strong future growth, as we saw signs of growth momentum in March as well as April. While last fiscal year was an upfront investment phase for future growth, we expect to move into a full-fledged profit-generating phase in FY25 through further sales growth as well as optimization of ISAV to achieve high profitability and appropriate expenses levels. We are currently planning an IR event focusing on the progress of the U.S. business and its future prospects and are considering holding it in the first half of the fiscal year. We will provide further details when they are finalized. On page 19, we use an image to explain the profit contribution of strategic products. or strategic compliance. The pink and gray bars represent the total sales and related expenses of the strategic compliance, respectively, while the lighter and darker bars represent COCS and SG&A, respectively. Sales are expected to grow significantly with the continued growth of BASF and Zospot, as well as the full-scale growth of Vioza and Isovay, launched in FY2023, and by Loi in FY24. As for expenses, while COCSIS is expected to increase in line with sales growth, SG&A is planned to be maintained at a certain level with the cost optimization through SMT. Profit contribution from strategic brands were limited in FY23, but full-scale profit contributions began in FY24. Rapid growth is expected in the future, and from FY25 onward, we expect the sales expansion of strategic products to directly contribute to profit growth. Page 20, key events expected in FY25 for strategic brands are described. For ISFA, we expect the Phase II study readout for Stuttgart disease in the second quarter. A MHW decision on the JNDA is expected in the third quarter. As of Part 7, the Phase II EV302 study targeting very solid tumors other than urothelial carcinoma, the readout of the first-line head and neck cancer cohort is expected to be available in the second quarter. We also expect to have interim analysis data from both the Phase III EV303 and EV304 studies in muscle-invasive bladder cancer in the second and third quarters. If the data favorable, we plan to proceed with the submission for an additional indication based on this result. In addition, data from the Phase 1 IV-104 study in NMRBC, normal cell-based bladder cancer, is expected in the third quarter. For viral data from the final analysis of the Phase 2 GLEAM study in pancreatic ductitis carcinoma is expected in the second quarter. In the fiscal 2025, we expect to see data from a number of clinical trials for expanded indications, which we hope will be successful and lead to accelerated growth of our key strategic brands. Page 21 is the future outlook for our forecast. area approach. As we have reported, we plan to make POC judgment in each of our primary focus flagship programs by the end of FY25. ASP3082 achieved POC decision in pancreatic duct adenocarcinoma at the end of FY2024. And then in 2025, we expect to make POC judgment in nosomal cell lung cancer in the first half of the year. NSERC in the second half of the year. Other programs remain unchanged from the plans for FAR. ASB 2138 is expected to achieve POC judgment in the first half of the fiscal year and 88405 and ASB 7317 in the second half. ASP7317 will make a presentation including early data from the ongoing Phase 1B trial at the Retina Therapeutics Innovation Summit in May. We will then move into the conversions phase depending on the results of the POC judgment. We'll prioritize allocation of management resources to the primary focus that have successfully achieved the POC, and we'll accelerate R&D for the flagship and follow-on programs to increase pipeline value. We expect the multiple programs generated from our focus area approach to progress and contribute to post-extended LOE sales and generate sustainable growth. Page 22 is our full-year focus for FY2025. Revenue projected to be 1,930 billion yen, an increase of 17.7 billion yen year-on-year. On top of the sales decline of Stadia and Manila background, Forex negative impact is expected, but thanks to the strong growth of the strategic brands, we expect revenue increase. Excluding the Forex impact, underlying sales are expected to be 2 trillion 36 billion yen 7% increase and continue to expand steadily. In the litigation over the formulation patent of Mirabegron in the U.S., we have recently received a ruling in favor of the validity of our patent. The lawsuit is still ongoing, but in light of the ruling, we have assumed that no other generic products will enter the market for a certain period of time. SG&A is expected to be 805 billion yen, a decrease of 38 billion yen year-on-year. Of this amount, co-promotion expenses for extended in the U.S. are expected to shrink in line with the decline of sales. Therefore, the impact on profit will be partially mitigated. SG&A excluding co-promotion fee is expected to be 576 billion yen, a decrease of 14.5 billion yen year-on-year. Cost optimization of about 20 billion yen is expected through SMT. Owned expenses are expected to be 342 billion yen, an increase of 14.3 billion yen a year. Investments will be focused on lifecycle management of strategic brands and primary focus achieved POC. As a result, we expect growth to be 410 billion yen, an increase of 17.6 billion yen a year, and a co-operating margin to be 21.2%. up 0.7 percentage points over the previous year. On an underlying basis, excluding the forex impact, the growth will be 435 billion yen, double-digit growth of 11%. In consideration of potential business risks, we have factored in the impact of US tariffs and others to a certain extent in COPY. The lower on the slide shows a full basis focused. OP is projected to be 160 billion yen, an increase of 119 billion yen a year. The main adjustment item excluded from the core basis is amortization of intangible assets, which is anticipated to be about 140 billion yen. In addition, we have factored in other expenses of about 110 billion yen. This includes impairment loss risk over 60 billion yen, which is the same level as in the previous year. Initial focus as well as expenses related to reorganization and forex losses. Page 3, today's summary. In FY2024, we achieved a record high revenue and a core peak. We expect further growth in FY2025 with double-digit profit growth in the underlying basis. Our strategic plans expanded strongly in FY2024. In FY25, we expect them to grow further and enter a full-scale profit contribution phase. In the primary focus, we achieved our first POC with ASP83082, a targeted protein degradation. In FY2025, we will accelerate the development of ASP3082 and subsequent programs. In addition, we will continuously judge POC in other primary focus. In SMT, based on the positive results achieved in FY2024, we will pursue further cost optimization. Continuing the momentum of FY2024 and FY25, we will aim to further increase the value of the pipeline, which will be the foundation for further profitable and sustainable growth. That's all from me. Thank you very much for your attention. Okamura-san, thank you very much.

That's all as for our presentation. We now would like to entertain questions from the audience. If you have a question, Please press the raise hand button at the bottom of your Zoom screen. If you're joining from a smartphone, please tap details, and then the raise hand button will be shown, so please press it. The moderator will name you one by one, so once your name is called, please unmute yourself on your screen, mention your name and affiliation, and then ask your question. Anyone with a question? Thank you very much. Thank you for waiting. First, Mr. Yamaguchi from Citigroup Securities please. Can you hear me? Yes, we can hear you. Thank you very much. Yamaguchi from Citigroup Securities. First, I have a question about your forecast. You factored in a certain level of risks with regards to tariffs. What kind of risks were included? How much? You incorporated the risks of tariffs. You were the first company to do so. You have Ireland and other specific situations. How did you think and how much was included in your forecast? What are you planning to do? Could you briefly explain? Thank you for your question. We incorporated these factors, but it's still very rough calculation results only. This is very uncertain and with lots of uncertainties. So how should I explain? Forecasting the actual impact is currently very difficult. We are not doing business just on our own. We have business partners with whom we collaborate, and we have to understand the potential impact. We have to discuss the necessary measures, and we'd like to implement those measures when necessary. How much, for what, is not going to be mentioned? We don't have a granularity of information we can share today based on our analysis. Next, about Isavay, your forecast for Isavay prescriptions. because of CRL kind of stopped, and then there is a growth trend after that. So you are assuming 80% growth. And some think that's achievable, others think it's not going to be achievable. The competitor may have a higher penetration rate by now. So based on your feelings, this is your company's forecast looking at the trends. Patients who were kind of away or coming back while they're waiting, you have again a growth trend. Could you please explain the current status in more detail? Thank you for your question. In 2024, in the first half, I should say, the market penetration started. There is a slope of growth. Unfortunately, temporarily because of CRL, It kind of stopped, or there was a slowdown to decline. But in February, we got the approval. And one month later, if you look at the data in March, there was a declining trend. And then there is a growth trend again, according to our judgment. So after April, it's going to continue the growth like the slope in the first half last year, according to our outlook. If you look at the size of the market, this is mentioned a lot. Some time ago, there was no treatment option for this disease. So patients are underdiagnosed. If there is no treatment, even if there is a diagnosis, nothing can be done. So diagnosis did not make a lot of progress before. retina specialists, patients who have already seen retina specialists, then the usage will be promoted rapidly, but if patients are seen by eye doctors in the community or patients who haven't seen even such doctors yet, how they would be referred to specialists is going to be a challenge. So we would use DTC to, and we are increasing, continuing the disease awareness campaign. And just accessing the retina specialist would not be enough. Patients may not be able to come to specialists, so our customer engagement have to be considered for the better. Sorry, I spoke too much. Klaus may have something to add. Klaus, please.