Thank you very much for your participation on this Astellas Earnings Call for FY 2022 Financial Results ended March 31st. I'm Ikeda, Corporate Advocacy Relations. I'm serving as the moderator for here today. This meeting is going to be provided via Zoom Webinar and also live streamin. You can attend this another way. After the presentation, we'll have Q&A session, questions are accepted only from Zoom Webinar, but not from live streaming. The participants for here today is Naoki Okamura, Representative Director and CEO. Yoshitsugu Shitaka, CScO, or Chief Scientific Officer. CMO, or Chief Medical Officer, Tadaaki Taniguchi. CCO, or Chief Commercial Officer, Claus Zieler. In total, we have 4 participants here from our end. Including Q&A, this session will be held with simultaneous translation in Japanese and English.
Accuracy of interpretation cannot be guaranteed by ourselves. Those attending from Zoom Webinar, please select the favorable language from the Zoom screen. When you select the original language, you can listen to the original sounds without translation. Today's presentation is going to be made based upon the presentation materials on our website. This material or presentation by representatives for the company and the answers and statement by representatives for the company in the Q&A session includes forward-looking statements based on assumption and beliefs in light of the information currently available to management, and subject to significant risks and uncertainties. Actual financial results may differ materially depending on a number of factors.
They contain information of pharmaceuticals, including compounds under development, but this information is not intended to make any representations or advertisement regarding the efficacy and effectiveness of these compounds. Okamura-san, please start the presentation.
Hello, everyone. I'm Okamura from Astellas Pharma Inc. Thank you very much for joining our FY 2022 financial results announcement meeting on a very busy schedule today. This is a cautionary statement regarding forward-looking information. As this was explained by Ikeda earlier, I'm going to skip this page. Page three. Today, before explaining the details of the financial results, I'd like to explain FY 2022 review as a whole and FY 2023 initiatives for achieving corporate strategic plan, CSP 2021, and prospects for FY 2024 and beyond. FY 2022 core basis results are almost in line with our expectations, but slightly behind our full year forecast. These were the results of aggressive efforts to tackle the stretched full-year forecast. In development, we achieved important milestones with products we expect to become major growth drivers for the future, such as fezolinetant, PADCEV, and zolbetuximab.
In our focus area approach, our active creation efforts have borne fruit, and Targeted Protein Degradation was selected as a new primary focus. On the other hand, each project aimed for POC, but unfortunately, no POC was obtained in these projects. We take these results seriously, turn them into learning opportunities to be leveraged for FY 2023 initiatives, so that we can ensure growth towards achieving CSP2021. FY 2023 is the turning point for CSP2021. We will continuously keep a strong commitment to the achievement of our targets. We position FY 2023 as the turning point to ensure growth for FY 2024 and beyond. As important initiatives in FY 2023, we can highlight the four items shown on this page. First, regarding fezolinetant, we have high expectations for it as a blockbuster.
We will make proactive investment with higher priority in order to realize rapid market penetration and sales expansion after launch. As for PADCEV, we are hoping that metastatic urothelial cancer first-line will be a major growth driver. We are expecting sales expansion in the United States and also progress in development for global submission. With regards to zolbetuximab, we will proceed with global submission and in parallel, make investment for market penetration after launch. Fourth, we will aim for sales expansion with new products and new indications, and at the same time, we actively promote investments to optimize the cost structure for the future. To improve operating profit margin in FY 2024 and beyond, we will thoroughly pursue operational excellence. As a result, we are forecasting similar level of the core profit margin in FY 2023 compared to the previous year.
When these investments and initiatives bear fruit, we think we can achieve about 25% core operating profit margin in FY 2024 and 30% in FY 2025, our target in CSP 2021. I'm going to explain the details from the next page. Page four is the agenda for today. I will start with FY 2022 consolidated financial results. Page five. Revenue and profit increased in FY 2022. Revenue increased 17% year-on-year. It was almost in line with our expectations, slightly behind our full year forecast. XTANDI, XOSPATA, and PADCEV expanded in line with the full year forecast. I will explain the product details later on page seven. On cost items. Cost of sales ratio was as expected. SG&A expenses were on track and increased year-on-year when Forex impact was excluded. R&D expenses were on track.
As a result, core operating profit increased by 17% year-on-year. Unlike the revenue, it was almost in line with our expectations, but slightly behind our full year forecast. On page six, I will explain FY2022 financial results. Revenue increased to JPY 1,518.6 billion, up 17.2% year-on-year, achieving 99.3% of the full year forecast. Core operating profit was JPY 286.9 billion, up by 17.2% year-on-year. The achievement of our full year forecast was 98.9%. You can see the Forex impact on the right-hand side of the table. Revenue and profit increased even when Forex impact was excluded.
The bottom half of this page shows our full basis results, provided that full basis profit forecast is the revised forecast announced on April 11, 2023. In the right bottom of the table, we included other expenses booked in the fourth quarter. We decided to file a submission, we booked JPY 38.6 billion as fair value increase of contingent consideration for zolbetuximab. The other day, we made a press release about the expected booking of about JPY 58 billion impairment losses as other expenses in the fourth quarter. We examined the numbers in detail and booked JPY 60.3 billion, including impairment losses of JPY 47.1 billion due to the review of future sales forecast for Evrenzo. Other expenses reached JPY 157.5 billion in the fourth quarter.
Operating profit was JPY 133 billion, down by 14.6% year-on-year, achieving 97.1% of our full year forecast. Profit decreased to JPY 98.7 billion, down 20.4% year-on-year, achieving 94% of our full year forecast. Please turn to page seven. I will explain FY2022 results for major products. First, XTANDI. Global sales grew to JPY 661.1 billion in FY2022, up by 24% year-on-year. Even when Forex impact was excluded, it was nearly double-digit growth. The results were almost in line with our expectations, but slightly behind our full year forecast. By region, U.S. was behind, which became a factor for the underachievement of global sales.
Labels of Patient Assistance Program or PAP ratio and the share of ZYTIGA generic competitors remained high, which affected our sales. On the other hand, despite the challenging environment, XTANDI continues to maintain the overwhelmingly leading position in the branded market across all indications. In Europe, we achieved our full year forecast, which was substantially revised upward in the second quarter, as mainly in Germany and Italy, M1 CSPC prescription increased, and demand substantially increased by 20% year-over-year. In the mid-term plan five years ago, we announced the peak sales forecast of JPY 400 billion-JPY 500 billion. XTANDI substantially exceeded those expectations and grew to a product exceeding JPY 600 billion in sales. As for PADCEV, global sales expanded significantly to JPY 44.4 billion, up by 104% year-over-year, driven by Europe and Japan in particular.
The results were almost in line with the expectations, but slightly behind our full year forecast. In the United States, despite a steady growth in actual demand, revenue from clinical orders was below expectations, resulting in the underachievement of the forecast. On the other hand, both Japan and Europe achieved the full year forecast, which was substantially revised upward in the second quarter. In Europe, launched countries increased to 21, and reimbursement was obtained in seven countries. In Japan, new prescriptions exceeded the expectations contributing to sales expansion. Regarding XOSPATA, global sales increased and achieved full year forecast. Sales expanded in all regions, performing in line with expectations, particularly in U.S., Europe and Japan, high market share was achieved in the current indications. As for Evrenzo, progress was significantly behind our full year forecast. We booked impairment losses and the sales trend was much lower than expected.
Intensifying competition continues to be a factor behind in Japan. In Europe, the situation still continues where we have not been able to differentiate from the existing standards of care. In the fourth quarter, we obtained reimbursement in multiple countries, including Italy, which we hope will contribute to sales in FY2023. Next on page eight, I will explain cost items. Cost of sales increased by 14% year-on-year, along with the revenue increase. Cost ratio was down by 0.5 percentage point year-on-year to 19%, in line with our expectations. SG&A cost, excluding XTANDI U.S. co-promotion fees, increased by 11.1% year-on-year. When ForEx impact was excluded, SG&A expenses decreased by 1.3%, or JPY 5.1 billion year-on-year. The ratio to revenue decreased by 1.6 percentage point year-on-year to 29.9%.
The achievement rate was 99.7%, with spending in line with our full year forecast. Personnel costs fell by about JPY 8 billion year-on-year, with global optimization of commercial-related personnel. We are trying to reduce sales promotion costs related to mature products such as mirabegron, which decreased our costs by about JPY 8 billion year-on-year. We are making active investments for new product launch readiness for PADCEV and fezolinetant. Sales promotion expenses rose by about JPY 12 billion year-on-year. We are able to reduce costs as expected, and necessary investments were made actively. SG&A costs were controlled in line with our initial assumptions throughout the year. R&D expenditure increased by 2.2% year-on-year, but 1.1% when ForEx impact was excluded.
There was an impact from the booking of one-time expense of JPY 13.7 billion for using a priority review voucher in the first quarter for the application of fezolinetant. When this cost is excluded, R&D expenditure decreased year-on-year. The achievement rate was 99.3%, in line with our full year forecast, including the expense for using a priority review voucher. From here on, I will explain our initiatives for sustainable growth. Turning to page 10, I will explain key events we achieved in FY 2022 for extending our strategic products. Progress in the past three months is shown in red. Regarding XTANDI, we obtained positive top line results from both Phase III EMBARK study in m0 CSPC and Phase III China ARCHES study in M1 CSPC Chinese participants. I will explain the details related to EMBARK study on the next page.
This is an achievement in FY 2023. With PADCEV, we obtained accelerated approval from U.S. FDA in April for the additional indication of locally advanced or metastatic urothelial cancer in cisplatin-ineligible patients in the first line settings. In China, our filing for previously treated metastatic urothelial cancer was accepted in March. As for fezolinetant, we received a notification from U.S. FDA that the review period would be extended by three months to secure time to complete their review. The new PDUFA date is set for May 22. Regarding AT132, we submitted a series of responses to clinical hold by FDA by March. We are discussing with the regulatory authorities continuously. As other updates, we published Phase III study results for zolbetuximab and fezolinetant respectively in the prestigious medical journal, Lancet.
For fezolinetant, we obtained positive top line results in Japanese Phase IIb study, STARLIGHT study. We will discuss the future development and submission plan with the regulatory authorities. With regards to XOSPATA, we obtained positive top line results for Phase III MORPHO study for maintenance therapy after hematopoietic stem cell transplantation in March. Unfortunately, we couldn't achieve primary endpoint. We will analyze the data in detail and then consider the future plan. In FY 2022 as a whole, we are able to achieve all important events in light of the initially announced plan, except for the delay in obtaining top line results due to the delay in accumulating events in EMBARK study. On page 11, I will explain an overview of EMBARK study and related updates.
In this study, nmCSPC patients with high risk of biochemical recurrence received placebo + dupilumab, enzalutamide + dupilumab, or enzalutamide monotherapy. If PSA is not detected 37 weeks after the initiation of the treatment, participants will suspend treatment until their PSA rises again. Regarding the primary endpoint of MFS, the enzalutamide combination group demonstrated a statistically significant improvement compared to the placebo group. Furthermore, in OS, a key secondary endpoint, a positive trend was observed. OS data is not yet mature, so we will continue our monitoring for final analysis. Also, for other secondary endpoints shown in the right middle on the slide, statistically significant improvement was also demonstrated. The results in detail will be presented at AUA 2023 on the 29th of April, U.S. time. Based on the study results, we are planning to file a submission targeting mid-2023 in the United States.
In Europe, we will have discussions with the regulatory authorities targeting a submission in the second half of FY 2023.
Also, we updated sales forecast by incorporating the sales trends so far, the newly decided submission plan in Europe, and the recent Forex rate trend. We issued guidance to forecast potential peak sales of JPY 600 billion-700 billion, but made an upward revision to JPY 700 billion or higher. We estimate the contribution of mCSPC indication to be JPY 40 billion-50 billion. We will update the peak sales forecast for other strategic products at an appropriate timing. From page 12, I will explain the progress in our focus area approach. Projects in clinical trial stage with updates in the last three months are shown in red. AT845 in primary focus genetic regulation will be explained on a later slide.
In immuno-oncology, ASP7517 and ASP0739, artificial adjuvant factor cells, aAVC, and ASP9801, intratumoral oncolytic virus, were terminated based on the clinical study data obtained so far. Bispecific immune cell engager, ASP2074 and ASP1002, achieved the first subject dosing in March as planned. In mitochondria PF, ASP8731 for sickle cell disease was terminated based on the data obtained so far. In Targeted Protein Degradation, ASP3082 was granted Fast Track designation by FDA in February for existing treatment-resistant pancreatic adenocarcinoma with KRAS G12D mutation. We are hoping that this will lead to the acceleration of the project. The right-hand side of the table shows the number of projects aiming for POC determination by the end of FY2025. As of now, we have 16 projects due to termination after POC in the clinical study stage, as well as the project termination in the research stage, as well as delay.
It's a pity that no POC was obtained in primary focus projects. We will continue to create projects in research stage and aim for POC in clinical or study stage so that we can obtain POC. On page 13, regarding AT845, I will introduce you the data from FORTIS study that was recently presented. At the time of data evaluation, four subjects received AT845 and were being followed up. three of the four subjects chose to discontinue standard therapy, that is enzyme replacement therapy or ERT, following administration of AT845. ERT is currently the only approved treatment for Pompe disease. It requires a chronic treatment delivered in biweekly infusions. We hope that AT845 will replace it with a single dose.
The study showed that measured functional outcomes such as FVC, or Forced Vital Capacity and the six-minute walk test, have been stable after withdrawal from ERT for up to 51 weeks in the longest evaluated subjects. The clinical hold was lifted in February, and activities are now underway with the aim of resuming dosing in the second quarter. The plan is to determine the POC, along with the data from subjects who will be administered after the resumption. On page 14, we summarize the main progress made in FY2022 with regard to the Rx+ program. Progress made in the last three months is shown in red. A partnership agreement was signed with Roche Diabetes Care Japan (or Roche DC Japan) for BlueStar digital therapeutics for diabetes patients.
In addition to tracking blood glucose data of diabetes patients using blood glucose monitoring system of Roche DC Japan, BlueStar is combined with it, aiming to provide a new solution to support disease management. In Japan, the company plans to begin clinical trials in FY2023, with the aim for approval as a combined medical product. ASP5354 has entered into an exclusive U.S. commercialization agreement with Stryker, a medical device company with strengths in surgical visualization technology. Through this partnership, Stryker will assist in the visualization of the aorta during surgery by providing a video system optimized for ASP5354. Stryker will promote awareness and use of the system in clinical practice through collaboration on sales, marketing, and surgical training with them. Next, let me talk about our focus and the key expected events in FY2023. Page 16.
Revenue is forecasted to be the same level as previous fiscal year in FY2023. As a premise for the full year revenue forecast, we have factored in the impact of the most recently confirmed shipment of generic Lexiscan products. The decrease in sales of Lexiscan is expected to be offset mainly by the launch of fezolinetant and the sales contribution from the additional indication of PADCEV for the first-line treatment in the U.S. The product forecast for FY2023 is explained in detail on page 18. Let me explain the expenses or cost items. We expect G&A expenses to increase year-on-year, and this will be year of investment to ensure growth in FY2024 and beyond. We will expand investments mainly in fezolinetant and zolbetuximab.
In order to achieve a core profit margin of 30% in FY2025, as stated in our CSP2021, we will continuously push operational excellences. We've been working for scrutinization to optimize cost structure toward FY2024 and 2025. Specific projects and initiatives are still under consideration. Excuse me. We will provide details as we move forward. We expect our R&D expenses to decrease year-on-year. We will expand investment in Primary Focus. On the other hand, we anticipate a decrease in development expenses for our key strategic products. As a result, we expect core P to remain at the same level as previous fiscal year. In anticipation of mid and the long-term growth in FY2024 and beyond, we are forecasting a 10-year dividend increase to JPY 70 per share for FY2023. On page 17, I will explain the performance focus for FY2023.
Revenue is projected to be JPY 1,520 billion, an increase of 0.1% year-on-year. The yen is expected to appreciate against the U.S. dollar compared to the previous fiscal year, which will have a negative impact on our performance, but we expect to absorb the impact and achieve the same level of sales revenue. SG&A expenses are expected to be JPY 661 billion, an increase of 4.9% year-on-year, excluding co-promotion expenses for extending the U.S.. SG&A expenses are expected to be JPY 485.5 billion, an increase of 6.6% year-on-year. R&D expenses amounted to JPY 251 billion, down 9.1% year-on-year. As a result, operating income is expected to be JPY 290 billion, up 1.1% year-on-year. As with revenue, we expect to be able to absorb the negative impact of foreign exchange rates.
The lower part of the slide shows the full base forecast. Operating profit is projected to be JPY 288 billion. In FY2023, we have included in other expenses an increase of about JPY 2 billion in fair value increase and contingent consideration of fezolinetant and zolbetuximab. Page 18 is the focus for major products in FY2023. First, XTANDI the focus for 2023 is JPY 669.9 billion, an increase of JPY 8.8 billion year-on-year. Excluding the impact of Forex, this would be an increase of 5% over the previous year. In the U.S., although we continue to expect the impact of PAP, and ZYTIGA generic, recent data shows an upward trend in the number of new patients and expect an increase of new patients further. We also expect to receive approval for an additional indication for nmCSPC in FY2023.
Although the contribution to sales in the fiscal year, in this fiscal year will be limited, we expect synergistic effects on existing indications by activating promotion activities. In Japan, we expect sales to expand mainly driven by the growth of mCSPC. In China, reimbursement for the additional indication of nmCRPC started in March 2023, which is expected to contribute to sales. On the other hand, sales growth in Europe is expected to be moderate because although driven by an increase in prescriptions of mCSPC, with volume growth in the mid-single digit range, it will be offset by the negative impact of an increasingly competitive environment and price pressure. PADCEV's forecast of FY2023 is JPY 66.7 billion, an increase of JPY 22.3 billion year-on-year. Excluding impact of Forex, this represents an increase of 54% over the previous fiscal year.
In the U.S., they expect substantial sales growth driven by the additional indication which was approved this month. We have already gained a high market share in second and third line treatment, and we expect first line treatment to be growth driver going forward. We also received information today that NCCN guidelines, which many physicians refer to when making prescription decisions, have been updated to recommend the use of PADCEV as first line treatment for mUC based on the result of the EV-103 trial. We look forward to its contribution for our future. In Europe, we expect further growth by obtaining reimbursement in big markets such as Germany, France, Italy, and Spain. In Japan, we expect continued growth as we seek further market penetration in the current indications. The regional focus of extending in PADCEV are shown on page 32 and 33.
The focus for the XOSPATA of FY2023 is JPY 49.3 billion, an increase of JPY 2.7 billion over the previous fiscal year. In the huge markets such as the U.S. and Europe, we expect continued growth through market penetration of FLT3 testing in the market. In the international market, we expect an increase in the number of countries where FLT3 will be launched and reimbursed, and we expect sales to grow. Finally, for fezolinetant, which is expected to be approved in the near future, we have factored in JPY 40 billion-JPY 50 billion in FY2023 forecast. Naturally, this figure includes the impact of the three-month extension of PDUFA date. The impact of the three-month extension does not simply mean that one-fourth of the originally projected sales of FY2023 will be reduced.
We expect a certain period of time from the launch of product till reimbursement. We are projecting a linear growth in each quarter. In other words, we estimate that sales will be reduced by about half from our original focus of FY2023 because the last three months, that is when we expect the greatest contribution to sales, will be postponed to the next fiscal year. Last year, we gave the guidance that we could expect mid-double-digit billion JPY in the 1st year. Please understand that we would have expected even higher than 40-50 billion JPY if the project had been approved in February as planned. We would appreciate if you could wait until the approval for further details and assumptions. We plan to hold a briefing after the approval to provide guidance on specific amounts focused and sales strategies to achieve them.
On page 19, I will explain the cost items for FY2023. Excluding our core promotion fee for extending the U.S., SG&A expenses are expected to be JPY 485 billion, an increase of JPY 30.2 billion year-on-year. As explained on page 18, we expect fezolinetant sales of JPY 40 billion-JPY 50 billion in FY2023. Although the PDUFA date has been extended by three months, we have set the highest priority on fezolinetant in FY2023 in order to achieve rapid market penetration and further sales expansion in FY2024 and beyond. We will continue to make proactive investment in addition, investment. In addition to this, we will also make investments in anticipation of the launch of zolbetuximab. We expect investment in these two products to increase by approximately JPY 50 billion year-on-year.
On the other hand, we will continue to reduce costs for mature products and expect a decrease of approximately JPY 8 billion year-on-year. SG&A expenses will increase in FY2023 due to the proactive investment in fezolinetant, but at the same time, we will aim to optimize cost structure. Although I cannot give specific details or a sense of scales at this time, we will the achievement of a core OP margin of 30% FY2025 by making sure of this approach contributing to FY2024 onward. R&D expenses are expected to be JPY 2,251 billion, a decrease of JPY 25.1 billion year-on-year. Investment in primary focus will continue to increase. We expect an increase of approximately JPY 8 billion year-on-year, mainly due to expanded investment in targets, protein degrader and gene therapy.
A one-time expense for priority review voucher of JPY 13.7 billion for fezolinetant will be a factor for the decrease compared to the previous fiscal year. Development costs for fezolinetant and XOSPATA are expected to decrease by approximately JPY 6 billion year-on-year. We will invest proactively for further growth and will continue to review the costs that now contribute to the improvement of competitive patient value. This year will be the year of further growth and optimization of cost structure of FY2024. Page 24 is the key events we expect to see in XTANDI and key strategic products in FY2023. XTANDI, we plan to file for additional indication for nmCSPC based on impact study in U.S. between June and August, and Europe in second half of FY2023.
Plan filing for additional indication of mHSPC in China around August to October based on China ARCHES study. Biszeptolide results from Phase III EV-302 study are expected to be available in September to November. The target indication for this is the 1st line for cisplatin-eligible mUC, and if the result comes on schedule and the data are positive, we expect it to be able to file it in the 4th quarter. The global submission for zolbetuximab for the treatment of gastric and GEJ adenocarcinoma is expected in the 1st quarter in the U.S. and Europe, and in the 2nd quarter in Japan and China. fezolinetant, a decision on the approval is expected by May 22nd PDUFA date. In Europe, we expect a decision from the regulatory authorities between November and January next year. Page 21.
Here are the main events expected in FY2023 for the primary focus projects. A total of four projects from genetic regulation immuno-oncology targeted protein are expected to enter the Phase I stage. The details of each will be explained at the time when they go into the Phase I stage. In the projects that have already entered the clinical study Phase, initial data for the monotherapy dose escalation part of the Phase I studies are expected for the DGKz inhibitor bispecific antibody ASP2138 and the KRAS G12D mutant degrader, ASP3082. For AT845 and ASP7317, the first dose are expected to be administered after resumption of clinical trials.
Although we do not have any projects, planned to achieve or obtain POC in FY2023, we expect to obtain initial clinical data for several projects which we hope will lead us to a POC in FY2024 and beyond. Page 22. I will explain our new promotion system for R&D projects. R&D operating model, in other words, newly introduced in April with the aim of accelerating the POC acquisition. At the R&D meeting held about a year ago, it was explained that we have reorganized our research organization structure from a traditional function-based hierarchical structure to purpose-based and agile organizations. As a result, the new primary focuses and approaches are being actively created by the research organization, so actual results are beginning to emerge.
This time, we have expanded its concept to include clinical development and shifted the focus of activities from the functional axis to the objective axis. The primary focus project axis and organizer to enable agile decision-making through empowerment. The leadership team from each primary focus consisting of representative for each function is established and it makes strategic planning for each primary focus. Furthermore, manages budget and oversight and pro-prioritize our projects from research to clinical phases. Day-to-day decision making for an individual project is delegated to each project team. Organizational structure was reformed and the rich layers between each project lead and CXO in charge was reduced. At the company-wide level, we have established a new meeting body called Kachi Committee, which is the governance body chaired by the CXO in charge, and a replacement of meeting body we have so far.
The Kachi Committee is responsible for prioritizing among the primary focuses and decision-making, focusing key development milestones. By strengthening the empowerment to each project, the primary focus needs to decrease the timing of visiting our corporate-wide governance body, and the system is designed to enable rapid decision-making on a project-by-project basis. This will accelerate the decision about POC in the future. We reiterated that we remain committed to achieving CSP 2021, and we'll proactively invest in promoting initiatives for the future in FY2023, making it a turning point to ensure growth from FY2024 onward. We'll achieve core PE margin of 30% and promote to build up a portfolio of late-stage development products through a new R&D operating model to ensure sustainable growth after the loss of exclusivity of Xtandi. Page 24. This is the last slide from me. This is about upcoming events.
We expect the fezolinetant will be approved very near future. We plan to hold an information sharing meeting after approval. The detail will be informed you when time comes. We hope you will be able to attend. Thank you very much. This is all from me. Thank you for your attention.
Okamura-san, thank you very much. That's all from us as a presentation. We are now going to take your questions. You can ask questions only through Zoom Webinar. You cannot send your questions through live streaming. If you have a question, at the bottom of the Zoom screen, there is a raise hand button you need to press. If you're joining from a smartphone, if you tap details, raise hand will be shown, so please press it. The MC is going to name you. Please unmute yourself on your screen, and please mention your name and your affiliation before asking your question. Today, we have Klaus, our CCO, in this room. As I said at the beginning, from the Zoom screen menu, you can select the original language.
You can listen to the original voice without going through simultaneous in-interpretation. If you want, you can change even at this timing. We are going to take your questions. Thank you for waiting. The first question is from Mr. Yamaguchi. He's from Citigroup.
Yamaguchi speaking. Can you hear me?
Yes, we can hear you. Thank you very much.
Thank you for your time. Fezolinetant, I have a question. You're going to explain the details into the future, I'd like to ask you a few questions as of now. I'd like to ask, three months delay. This is due to a process issue. It's not about because of the questions about the drug itself. Is my understanding correct?
Yes, your understanding is correct. We were not told to submit any particular new data, but the data we submitted is to be reviewed by FDA, and they need more time. Predetermined three-month extension was communicated to us.
Understood. The second question, that's about the sales. You made an explanation verbally. This JPY 10 billion and JPY 100 billion in between of that. According to your explanation, we have that number.
With this, three months delay, as a result, you reduce it, and that result is between JPY 40 billion-JPY 50 billion. I believe that was your explanation. Is my interpretation right?
Yes, that is right.
Thank you. In media also, just like you mentioned, tail heavy is likely to be happening. Therefore, the impact onto the sales is larger. For other sales would have been increased. The SG&A, that is JPY 50 billion against the JPY 50 billion year-on-year. What do you think about it? With this delay of three months, is there a further increase or decrease on this?
Thank you for the question. This three-month delay of the sales, that cannot make it possible to reduce the initial investment for SG&A.
The same level of the investment will be necessary. On top of that, this three-month delay means that the peak that we can achieve might be reduced. In order to avoid such kind of feeling, rather I would like to get into the market as early as possible for catch up. At the time of the full year, this level of the SG&A will be necessary support. Suppose there is a such number, rather in FY2023 budget, we book a further larger amount compared to that. Having said that, we haven't decided we are going to use it all from the beginning because this is a new treatment therapeutic area for us. SG&A resource mix probably might be different from the past. Not only MR, but other digital channels will be introduced for the communication of the information.
Looking at the situation, we would like to do some detailed adjustment. Thank you.
Okay. As for the insurance with regards to fezolinetant.
There may be many patients with private insurance because of their age. In spite of the three-month delay, negotiation with the payers have to start before approval. Feedback, it may take some time in terms of the timing, but insurance related feedback from the payers, anything you can comment right now?
Thank you for your question. Regarding such details, we are going to explain such details at a meeting we are going to hold after the approval. Understood.
It's not related to the financial results announcement, but Okamura is now CEO and CFO, wearing two hats right now. Regarding the new CFO, what's the situation right now?
Thank you for your question. It's vacant, as you know well. CFO, we have an external posting to search for candidate. Of course, we also have our own list, and from outside, some are approaching us. How should I explain? More than 10 candidates have been identified by now. If possible, in 2023, by the time when we announce the first quarter results, I hope that a CFO will join us. That's the sense of speed in my view. That's all from me. Thank you very much.
Thank you very much. Next, Daiwa Securities, Mr. Hashiguchi, please.
Thank you very much. Toward the end of your presentation, CSP2021 achievement is something you mentioned that you commit to. According to the page 23 slide, in such target, OP margin 30%, that is the only number described here. The original performance target, I think there are mainly three of them. XTANDI and key strategic products or exceeding JPY 1.7 trillion. JPY 50 billion in 2025 and afterwards in the focus area and such. There are other targets were established, but on this slide it seems that you have less emphasis on the other targets and the core OP is still your sole target this time.
I would like to hear the current progress for other targets than this core OP. How do you think about it? How do you feel about it?
Thank you very much. Mr. Hashiguchi, have a good understanding about the CSP 2021 performance goal. This 30% is the number three target, and we are not giving up the number one and number two target. On this slide, the context here is that as Lenet and PADCEV and bixalomer growth is where we are going to invest for FY 2023. Because of that core OP rate in 2023, it will be ended up with 19%. With the coming two years, the target number three, 30% core OP is committed to be achieved. This is just focusing on the number three target on the slide.
The sales is smaller and core OP 30% alone is achieved. In that case, the absolute value of the profit is going to be smaller. The performance target of number one and two are still we are committed to. Thank you very much. This is the end of our fiscal year earnings call, that's why you focus on the target number three. That's all. Thank you.
Focus area. Focus area approach outlook is something I'd like to ask you about. one or two may be successful in the end, JPY 500 billion in the end would be in your sight sufficiently. When you developed your CSP, at that time, there can be a variety of scenarios based on the simulation. The median amount could be JPY 500 billion.
Based on the progress by now, as a median value, it may be declining. Is it better to think that way? Focus area approach in around 2030, how much revenue you can generate? What about the probability of achieving such scenario? I'd like to hear your view, Okamura-san. Thank you.
If you show slide 12, it's difficult for me to explain. As you remember, our internal performance goal number two is 2025. At the end of that year, pipeline value we internally calculate is the definition. From those from outside in society, there's no way to calculate this. We say we have this much value being accumulated, but you cannot examine the data. What did we do?
Monte Carlo simulation was performed. The pipeline in ten- FY 2030, what is the, how much revenue it can generate? We calculate the power as an example for 2030. What I want to say here is that as revenue in FY 2030, if there is a 1-year delay, the revenue will decline that much. The revenue will fall much. In terms of the value, it may not be affected so much. In that sense, FY 2030 revenue... What we explain there, I wonder whether it was a good idea or not. Instead of the sales amount in FY 2030, the pipeline value in 2025, after the, it's the sum of the net present value, after adjusting the probability. We don't have POC, you may say so. Yes, you're right.
By being able to obtain POC, the value of the project will go up a lot. What we try to do with focus area approach is the primary focus triangle, flagship project would be generated out of there. Also multiple projects will come out one after another. Flagship would be in the clinical study. Others may not go into the clinical studies. Once it's successful, we'd be able to be aggressive in sub-subsequent follow-up projects. If we can get and obtain one POC, that project value would go up. The subsequent project value would also follow. What about the FY 2030 revenue? JPY 500 billion could be a difficult goal. Sometimes I feel that way. 2025 pipeline value, from that perspective, it's not impossible in my view.
Thank you very much. Okay, Taka.
Now in SSP, the SG&A is being maintained as absolute value, and they'll be increasing this fiscal year. The next fiscal year or even after that for us, what kind of perspective should we have?
Well, this fiscal year, fezolinetant sales might not contribute so much, but we have to spend our money for SG&A. We have to set the preparation for zolbetuximab. That's why we have to experience the increase of the cost. Because of that, we are thinking about not investing others. That is not the case for FY2024 and 2025. That we can improve our profit and loss structure, we would like to do some methods if that is available.
So that we can invest in that area as well, we would like to secure a certain portion. That's why I come up with this number of the core OP of 90%. Of course, if we couldn't find such other method, then the profitability would go up. SG&A maintains the absolute level, same level. That doesn't mean that we have the same level every year. As the landing point of FY 2025, while the sales increases, but absolute value of the SG&A, it would be suppressed so that we can increase the core OP rate. That's the way of the calculation, so you don't need to worry much. We showing we are experienced the effect of this SG&A control. We started to learn that how we can well control the SG&A.
Okay, thank you.
Thank you very much.
Thank you very much. Next, Morgan Stanley MUFG Securities, Mr. Muraoka please.
Hello, Morgan Stanley's Muraoka speaking. Can you hear me?
Yes, we can hear you. Thank you very much.
I also have a question about fezolinetant. I understand we need to wait for the meeting, but I'd like to ask you about how we should think about it. First quarter, there is almost going to be no sale or revenue. In the second quarter and beyond, in principle, there's going to be linear growth of sales over 12 months, JPY 40 billion-JPY 50 billion. Is that the right image? Or somewhere, including the insurance coverage, there's going to be a turning point to have JPY 40 billion, JPY 50 billion in the end. Could you give me a clue?
Regarding the detailed numbers, and also how we will develop a relationship with the payers, that is going to be explained at the meeting after approval in more detail and more accurately.
When you say linear, what is going to be the size of the three months delay? What about the size of the impact?
That's a metaphor, when I say, why don't you use the math. On a full year basis, if there's going to be a linear growth of sales in the first quarter or one triangle or 3, 5, 7. 1, 3, 5, 7, and 16 triangles on our full year. If there's going to be a three months delay, the seven triangles would come to the next quarter.
Seven out of 16 will be gone, so it's almost half. This is a metaphor. The sales plan we developed from the day one to be an inflection point to grow more towards the end. I may be repeating myself, but for the detailed plan, that is going to be explained at a meeting after approval.
Okay. Understood. Thank you very much. One question. Another point in the plan, Lexiscan, JPY 27,270 is the sales plan, and the generic is launched according to your explanation. What about then, in this case, the downside risk? Is it necessary to consider about that? What should be the precondition in this case? Would you give us some guidance?
Well, this is about the United States. Once generic becomes available, the market is dominated by the generic that is the general situation. We have several our own reasons. It would not go down to complete zero. Rather, we believe that we can continue certain level of the sales. That is a precondition. That's why this number. Of course, there might be a certain level of the downside risk, but to set extend with using our own insight, we come up with this number. Claus Zieler is here, if he has additional comment, we are very happy to hear that. What about you, Claus?
You explained it very well. You know, we have multiple generics on the U.S. market. We have confirmed their shipment, and it is now a question of confirming that the penetration of the generics will be in accordance to our estimate. Of course, there can always be deviations from those estimates, as time goes by.
Thank you very much. The results this year, I'm afraid of any shortage, but year on background, you're expecting a decrease in revenue, but actually it was increasing. Is that because of the competition and the unit price again or Forex?
We may need to examine the details, but based on my gut feeling, it may be because of the Forex. Oh, I see.
Any particular reason? Okay, understood. That's all from me. Thank you very much.
Once again, we will check again. The corporate advocacy will contact you again at a later date after confirming the details. Thank you. That's all from me. Thank you very much.
Thank you. Next, Goldman Sachs Japan, Mr. Ueda, please.
I'm Ueda from Goldman Sachs Japan. First, I'd like to ask you a question about assumptions about PADCEV. In the United States, first-line, was approved and it's now included in the guidelines recently. Looking at the numbers in your plan, it's going to may not be accelerated so much. The denominator is getting larger and I understand that. What's your assumption? Are you having a conservative look, or what is going to be the speed of market penetration for the first line? If you can answer these questions, that would be highly appreciated.
Thank you for your question. The growth of PADCEV is of course driven by the approval in first line in the United States that we obtained in the beginning of April. That is a substantial increase of the available patient pool in the United States. Our share assumption would be over 20% of that first-line patient pool in the United States. On the basis of that trajectory, we have built a model that would add more than $100 million to PADCEV in the U.S..
Okay, understood. Thank you very much. Second question, and that is about the premise of the plan. The plan for this fiscal year, how do you see about the cost ratio? If there are some factors that might worsen the ratio of the cost, would you please explain about it?
As for the presentation of the certain factors worsening the cost of the sales ratio, let me answer that later on.
Okay. In the meantime, let me ask you, this is again about the premise of their plan. Fanapt, MYCAMINE, profit for the transfer. So for our core bases, are there any tentative or transient factor because of this?
Might come in, JPY 9 billion . That is what our staff is saying.
Thank you very much. That's all from me.
Thank you very much. On, about the, a question about the sales cost ratio. Well, basically the products mix will be changed, but roughly speaking, this cost of sales ratio as for the ratio basis is going to be the stable level.
Understood. Thank you very much. That's all.
Thank you very much. Next, Mitsubishi UFJ Morgan Stanley Securities, Ms. Kumagai, please.
Can you hear me?
Yes, we can hear you. Thank you very much.
First question about SG&A cost, JPY 50 billion+ . Most of this is related to fezolinetant. After approval, there can be a more detailed guidance. What kind of items are included in here? Anything you can tell us?
To the, session that we will have after approval, if I may ask you to wait until then.
Understood. Thank you very much. AT845. Looking at the six-minute walk test, there seems there is no improvement, but is it good enough because it's maintained for AT845? There seems to be no dose dependence, but could you explain how to interpret this? Taniguchi, Chief Medical Officer, is going to explain.
Thank you for your question. First of all, six-minute walk test. There is an arrow, as you can see here. The standard care is the ERT, enzyme replacement therapy, which is discontinued in three subjects. Even without ERT, the walking distance has not changed. In that sense, it's a clinically meaningful data. For these patients, Q2W, they come to hospitals for IV infusion to receive ERT because they have troubles with their bodily conditions. It would cause a lot of trouble for them. Just one gene therapy administration to maintain their function, that's very meaningful and significant for them. At this academic society meeting, this data drew a lot of attention. As for the dose and dose response, must be closely looked at from now on.
Needless to say, at all doses for the time being, we see a certain level of response and effectiveness, including safety. We have to take that into account to determine the optimal clinical dose.
Understood. Immuno-oncology program, three projects are discontinued. That is because you want to reallocate the resource for the remaining projects. How do you view about the immuno-oncology projects now?
Thank you very much. Regarding immuno-oncology, within this primary focus area, we put further onco focus on this. Again, these three projects are discontinued as it was decided because it met the discontinuation criteria that was set from the beginning. The study result met the discontinuation criteria. That's why we decided to discontinue.
This type of decision-making is, quite, difficult. We've introduced this criteria for the discontinuation, and we just follow that so that, we can reallocate the resources, for the more promising, area. Especially for immuno-oncology, ASP2138, needless to say, bispecific antibody is in the middle of Phase I study. There are other two bispecific antibody projects went into the Phase I study. We can expect further for this area. Thank you very much.
Thank you very much. Next, JPMorgan Securities, Mr. Wakao, please.
Wakao from JP Morgan. Thank you very much. First, as was mentioned by others for their questions, SG&A cost to be returned to the FY 2021 level. It was like JPY 41 billion, rather, JPY 410 billion. There is a difference of JPY 75 billion compared to JPY 485 billion. The fezolinetant expenses you're going to use this fiscal year are going to fluctuate. JPY 50 billion may not be necessary as of 2025. You're going to reduce the cost to reach JPY 410 billion. Well, we have JPY 410 billion. The Forex rate and 2023 Forex rate can be very different.
Even if we say it's the same amount, in terms of the absolute value, but the Forex is going to against depreciation, it's very difficult to make them comparable at the same level. In terms of the operational structure, sales amount would be in various currencies. After distribution, sales in various currencies and there are also expenses in various currencies. If there's going to be an inflation because of the currencies, there's going to be inflation in cost as well.
The second one is related to already asked questions. It's about the performance of the primary focus. You mentioned this will lead to the sustainable growth. As of now, the purchasing, acquiring those on the later stage is not something you are thinking about.
Would there be a certain timing where that you need to do certain sort of the acquisition of such from outside, considering the pardon, cliff or so, you have to think about something like that. You have the primary focus, you need to think about the certain time issue. Do you have any time limit for working for the primary focus?
That's really good question. That is a question relating to the success of the CSP 2021. This focus area approach, the way of coming up the innovation is also relating to your question. Now we have CSP 2021, not thinking about others.
We just pursue for our CSP2021 to do the activities that was decided in April 2021. That is not the course that we are doing. Of course, the change of the environment are taken into consideration. For example, XTANDI U.S. is materialized, Lexiscan is available. However, generic came into the market earlier than we expected. We have to deal with such factors. It is true that the POC is not really obtained as been expected in our primary or in our focus area. Of course, we have to work harder internally, but depending on the situations, we would like to introducing something outside of the company. We have such a variety of things on our list.
That we face the timing where we have to get something from outside. We have the preparation done, ongoing here. It's not something that a certain point of time we are going to do M&A, if something come up, in that case, we will let you know.
Thank you very much. Next, Credit Suisse Securities, Mr. Kasuga, please. Sorry, Ms. Haruta. Haruta from Credit Suisse Securities.
First question about XTANDI. Peak sales JPY 700 billion or more, you made an upward revision. Peak sales trend for the future, how should we think about it? Within this year in the U.S. Inflation Reduction Act, your drug may be subject to the drug price reduction list.
There can be a possibility of the price reduction from 2024 towards ROE. Peak sales must emerge, but because of the IRA Inflation Reduction Act, what's your assumptions? What's your view on this?
Thank you for your question. Regarding this issue, it's very complicated. It contains a lot of complexities. First of all, the Forex rates are changing. We talked about JPY 500 billion-JPY 600 billion range. We already reached JPY 600 billion. Are we going to say that there's going to be no more growth? No. We are saying that it's going to grow even further into the future. That's one thing. EMBARK data is approved, so there's a possibility of an upside as an addition. That's why we are changing to JPY 700 billion as a guidance.
The impact of IRA, needless to say, U.S. commercial people are mainly developing a variety of scenarios and doing a variety of analysis to think about what kind of ways can mitigate the risks. What should be the priority and from when are they going to do this? Are they doing such analysis? As you pointed out, XTANDI products like XTANDI of the side, it may be on the list. We are including that possibility in our assumption. On the other hand, whether it's going to be included in the list or not, we don't know yet until that time comes. If it's listed, what is going to be the price negotiation after that? It's very unclear right now. What kind of price the authorities are going to propose and offer, we don't know yet.
Regarding the proposed price and what kind of opportunities would be given to us to protest that, what kind of data can we do and how much can we push back to achieve a success? We don't know yet. We shouldn't speculate. We shouldn't share our views right now. Maybe you can wait for some more. Once we know more facts, we should explain more appropriately. I think that would be better. That's all from me.
I understand your situation. Thank you for explaining the details. Understood.
Second question. Primary focus decision making, you have established a new operating model. What was the decision-making problem in the past? With this new way, how it will be improved? For the agile decision making, this primary focus is on those on the phase for the gaining POC. In this agile decision making, in what way you would do the clever decision making?
Well, for this operating model, that Taniguchi took the initiative. He's going to explain that. Let me explain about it. As you see it in here, what's changed greatly is this governance. Now, governance is consolidated into one. So far we had governance in R&D, and we had governance for the corporate wide. There are two, but it was consolidated as a culture committee.
In that way, more agile and appropriate decision is possible to be done. There are necessary members there always. Including us, the appropriate CXO or chief executive members will be the members for the right decision making. We can commit to the project budget and also timeline. The second point is that this PF leadership team you see. So far, this PF leadership team was not officially established. Well, at each level there is a team and for each portfolio, primary focus portfolio was looked at. This time, it is going to be delegated to this leadership for the budgeting as well. Prioritization in the therapeutic areas will be also done by these teams.
Including the future investment and also new strategies will be considered by this leadership team. Underneath, there is the project lead. That is about PF lead. Under that, there is a project lead. We have lower layers. Day-to-day decision making can be done on each team level, which leads to the accelerated decision making. At the same time, to this project lead, the certain level, the delegation is done. With that, roles and responsibility of this lead will be clarified. That leads to the agile and appropriate decision making and also appropriate investment. Also, of course, we have the functional access as well. That focuses on the center of excellence in a particular therapeutic areas.
The capability levels belong to those area would go up. This is a complete metrics model that we came up with.
Thank you very much for the detailed explanation. That's all.
Sorry, I read your name incorrectly. Sorry for that. Next, Mr. Kotani from Nomura Securities.
Thank you. Kotani from Nomura Securities, can you hear me?
Yes.
First, fezolinetant. SKYLIGHT 4 study details was published in a paper in April. Looking at that paper, if you take a closer look, 45 mg of fezolinetant to patients with the endometrial or adenocarcinoma, there's a thickness in one patient and one patient on placebo. FDA may be taking a close look at this data in the paper. According to the paper, within the specified range, there should be no problem. I'd like to confirm with fezolinetant in terms of safety, FDA has any particular concern about its safety? That's my first question.
Taniguchi is going to explain. First, regarding fezolinetant spotlight study, published in The Lancet, I'm sure you're talking about it. Thank you very much for explaining the details. Needless to say, FDA or any regulatory authorities would take a very close look at safety in addition to efficacy. No difference among different regulators. Safety portion, as you mentioned, regarding cancer cases, they're reviewing all these details. Right now, review is now ongoing, so we cannot share the details today, but the target date is May 22nd, and that's the PDUFA date. Review is making progress towards that date right now.
Understood. Second question about the launch of fezolinetant, it will not be the linear launch in my understanding as well. However, the number is higher than I've expected.
My question is, this submit the three digit is what Shitaka-san mentioned as their focus. That is around October. After that, you know, the comm and such kind of site is utilized for realization, the realization of access for the HCPs, and also the disease awareness activities for the patients are also taking place. The launch factor is the reimbursement price and also the level of the awareness amongst the doctors. The price may not be that high, I expect. You have the clear view about those factors, that's why you come up with this number. That is my understanding. Is that right?
Well, each individual factor, I rather not talk about it here.
Naturally saying, ideally February 22nd, the authority would have made a decision and seeking that, looking at that timing, we came up with number. In that respect, the various factors are now clarified to a great extent. That's why we came up with this number.
Understood quite well. Thank you.
53E54, congratulations for your collaboration with Stryker. NIR-F visualization for surgical operation, that company was the first. It's more advanced as an ideal partner in my view. This Phase III study design, I took a look. In Phase II, it's limited to just some procedures, but this is the overall abdominal procedures. This is a company for artificial hip device companies. There can be damage. Are they talking about that area as well? This is my last question.
Thank you for your question. Stryker, for near-infrared fluorescence image visualization, at least in the United States, it has an overwhelmingly larger share compared to others. Even outside of the United States, they are very aggressive in other markets as well. In that sense, we think they are an ideal partner for us.
The target procedures for the clinical studies, what is the scope?
I don't have the established good data in front of me, so we will check and come back to you. Taniguchi can explain.
In the clinical studies, we have, I'm sure you have seen the protocol, the pelvic as well as the abdominal surgeries and ureter can be visualized to prevent the damage to the ureter. That's the objective. As an endpoint, visualization is mainly the important area as an endpoint. That's what we agreed with, we need to agree with the regulatory authorities as we proceed.
Regarding the hip joint, any mention about the artificial hip joint?
No such discussions as of now. In principle, ureter damage can occur with a hysterectomy or gynecological procedures, OBGYN procedures or general surgical procedures and the intraoperative ureter damage is the bigger number of cases. So we just start with what's occurring more frequently. So that's what we'd like to focus on.
Understood. Thank you very much.
Thank you very much. We are coming to the time to close this session. Following will be the final question from Nikkei Newspaper. Mr. Yamada, please.
Nikkei Newspaper, Yamada is my name. Can you hear me? Yes, we can hear you. Thank you. A lot of questions were already asked, so there is only just one question. Primary focus, there are no POC obtained yet. For that, I have one question. R&D organization is revisited and you are going to change the governance. Governance is going to be changed, which, and this leads to the agile decision-making, which is wonderful. POC, again, not obtained to this extent. Is that because the governance alone is a problem? CSP2021 was established and it's been a while since then.
By looking back the management and also the development, what kind of challenges are you seeing in front?
Well, first of all, from me, I would like to talk about my own view. After that, I would like to hear from Shitaka and Taniguchi. This is not only the matter of their governance, but the governance issue is has a certain weight, which means that we have to understand the status and the situation for the early and precise decision-making. For that purpose, team is important.
What about the organization of Astellas so far? It is a functional organization and there are many layers. The people supposed to be in the decision-making process has the long distance to the level who has the authority of the decision-making.
In that organization, although you have a good discussion within a team, nothing can be decided because we have to bring it, escalate it back to the boss, and then you have to bring it down back to the team once again. Decision come up with different opinions leading to the different decision-making. That's why we thought the team should have the ownership and having a delegation to make it agile.
Yes, the governance itself is changed in this way, but the impact of that is greater than you just consider as the organizational change. Yamada-san, I think, you are asking where, how we should find the candidate or how we can make use of the modality in a, in the effective way.
I think, in that case, Shitaka or Taniguchi can answer to you.
Shitaka, in charge of the R&D, would like to answer to you first. We have a focus area approach, a primary focus. As you see on the page 12, as a list of such projects that we have, we came up with a platform and we come up with the products one after another from that is what we are aiming at. Unfortunately, within these two years, there's nothing we were able to prove from this platform. Just like Taniguchi mentioned, bispecific platform or immuno-oncology cellular therapy platform or gene therapy or TPD, Target Protein Degradator, we have such leader programs of the platform. Those are in the phase of obtaining a POC. In other words, we are on a critical Phase now.
There, we can get the POC for a certain platform. In that case, we can think about the next program and probability of success for them is likely to be increased greatly. In the past two years, the result is unfortunate, but the leader program for each program is facing the very critical point. That's my understanding.
Shitaka made a comment. As he said, the platforms are being reinforced in various projects towards IND. They are proceeding towards IND right now. What about the clinical side?
What we are focusing on right now is the reinforcing the early development team. We have the pipeline, as you know. We had many in the late phase development. We used to focus on those for the past few years.
That's not wrong, and we think that's very important. We have to be very serious to tackle the focus areas in early development. We need to accelerate, as you are suggesting. We are changing the organization to that end and new talent being hired and acquired from inside and from outside so that we can accelerate further. That's what we are thinking about.
Thank you very much. We understand how serious you are. That's all from me. Thank you very much.
Thank you very much.