Eisai Co Ltd

Thank you very much for taking your time to attend the financial results presentation meeting of ASI Company Limited. It is now time we would like to begin financial results presentation for the first quarter of fiscal 2024. This is held in a hybrid format with attendees in person in this hall and also attendees who are attending virtually. Please find a flash report and presentation materials for those of you who are attending in person. Those of you who are viewing online, please check these materials from ASI's website. I would now like to introduce the presenters today. Representative Corporate Officer COO Keisuke Naito and CFO Mitsuru Shomon. Mr. Shomon CFO, please start.

I will now explain our consolidated financial results for the first quarter of FY 2024. In the first quarter of FY 2024, despite the continued proactive investment in the growth of Lecambi, both revenue and profit increased in the pharmaceutical business, and both revenue and profit were in line with the business plan, and we could make a good start relative to the focus for the fiscal year. First, revenue was 189 billion yen, down to 96% of the previous year due to the impact of the one-time income recorded in the previous year, Below, you will find that revenue from pharmaceutical business, which is our organic business, was 186.6 billion yen, up 3% from a year earlier due to the growth of what we call three Ls, or Lembima, De Vigo, whose generic name is Lemborexant, and Dekembe. Cost of sales was 39.8 billion yen, accounting for 21%. Thank you very much. Other income was 5.4 billion yen. As a result, operating profit was 13.4 billion yen at 52% of the previous year's level, and the profit for the period was 11.5 billion yen, 55% of the previous year. But as I mentioned earlier, these were in line with the business plan, and we could make a good start for the fiscal year relative to the forecast. Next slide. This shows the breakdown of revenue migration. As shown at the top left, revenue for the first quarter of FY23 was 196.9 billion yen. In the first quarter of FY24, in the pharmaceutical business, Renbima was up 5%. 12.8 billion yen, or 18% from a year earlier. Davigo increased 2.7 billion yen, or up 29% year-on-year. And in addition, Rekembe grew 6.2 billion yen year-on-year, and by 2.2 times from the last quarter. These three yields above the growth of their pharmaceuticals drove the growth of the pharmaceutical business, offsetting decreasing factors such as the termination of the Humira marketing partnership in Japan in June last year, which is included in the bar above for products other than 3Ls, resulting in an increase of 4.8 billion yen in revenue. On the other hand, as shown in the blue box at the bottom, due to the impact of one-time income of 12.3 billion yen from the transfer of all future economic rights by the Cestron recording the previous year, revenue from other businesses decreased This slide shows the breakdown of operating profit migration as for operating profit as shown in the second lowest blue box.

A portion of the deposits ASI previously received at entering into the global strategic collaboration for Morab 202, 4.8 billion, was recorded. This was from BMS following the end of the collaboration, which was 4.8 billion yen. This was booked last year. However, as stated in the line below, revenue from one-time payment last year had a major impact. As a result, it was down by 12.6 billion to 13.4 billion, or a decline of 52% year-on-year. Despite the decline, thanks to the growth of 3Ls, we were able to proactively grow investment in Lakembi at the same time as increased segment profit of pharmaceutical business. Fiscal 24 consolidated financial forecast, which remains unchanged since May disclosure. We will continue to focus on our efforts on three Ls, including Lakembi, and maintain financial discipline to control cost and expect growth of both revenue and profit. Without falling into short-termism from mid- to long-term perspective, we will continue to proactively spend on Lakembi to sustain the enhancement of corporate value.

Now, let me talk about the progress of Lecambi. First, let me talk about the regulatory update and rapid expansion in launched countries. Next, here is the global regulatory update. I will report on this status. So I will report on the status of applications for maintenance treatment and subcutaneous formulation, which are important life cycle management issues, and the status of submissions in countries and regions. The regulatory processes of IV maintenance treatment and SCAI maintenance treatment are all progressing steadily. In addition to the U.S., Japan, and China, Lecambi has been also approved in South Korea, Hong Kong, and Israel. And we will continue to expand the number of countries where it is approved. We request re-examination of the CHMP opinion for approval in Europe. Within 15 days after receipt of a CHMP opinion, the re-examination will be conducted with new rapporteurs and new members. I will explain in more details in the next slide. For the European submission for approval, on July 26, the CHMP adopted a negative opinion on the marketing authorization approval after considering the balance of benefits and risk. Let me express the company's position on this. The protocol and statistical analytical method for the Phase 3 Clarity AD were determined in advance in consultation with global health authorities, including the EMA, the upper body of CHMP, and the endpoints were determined as such. In this study, Recanimab achieved all its primary endpoint and all key secondary endpoints, all of which had been consulted on in advance, demonstrating statistical significant results. However, such an opinion was adopted, which I would like to reiterate. For benefits, these efficacies have been sustained up to for a long term of 36 months as presented at AIC 2024. Alzheimer's Association International Conference recently held even further promoting clarity AD results. even further supporting clarity AD results. On the risk side, data also confirmed that the incidence of ARIA, a main ADR, was very low at six months of treatment, and most cases were asymptomatic. The incidence of ARIA in actual clinical setting is consistent with clinical trials and is well managed in accordance with the guidelines set by regulatory authorities. So far, for both risk and benefits, we are confident in clarity AD results. Therefore, we will seek reexamination of this opinion. In order to provide this treatment to patients with progressive and fatal AD, as soon as possible, we will work closely with the CHMP to seek early approval in Europe. Next slide, please. Here, I would like to present actual global results for the KMB. The quarterly global revenue was 6.3 billion yen, increased by 2.2 folds from 2.8 billion in the previous quarter. This growth was due to that the U.S. and Japan entered in prescription expansion phase while we started selling in China from the last week of June. It is progressing in line with the business plan toward achieving fiscal year 2024 revenue forecast. Next slide, please. Here, let me show you the situation in the United States. As frictions expand, the number of medical institutions ordering can be increased by approximately 40% compared to the previous quarter. The average number of orders per medical institution also increased by approximately 30%, and the sales of vials to medical institutions increased by approximately 1.7 times compared to the previous quarter. Monthly revenue also continued to grow, reaching 2.1 billion yen for the month of June. Increasing the number of NAS who provide information on the value of Lecambi as specialists in the neurological field was increased in July, and the commercial structure in the U.S. now has approximately 450 positions, which include biogenes personnel. We are aiming at further expansion. We will leverage the latest data presented at the AAIC, which we released recently and will be discussed in a moment, to feature the potential benefits of patients through early initiation treatment and continued treatment after plaque removal. The incidence of ARRIER in actual clinical settings seems to be within the range in the U.S. packaging set. Thank you very much. About 800 physicians have started prescribing Lecambi so far in fiscal year 24, all of which show that progress has been steady. In addition, the number of physicians who have administered Lecambi to 10 or more patients has increased to 70, and as shown in the figure, the sales to medical institutions have been steadily increasing. The incidence of ARIA remained within the range indicated in package insight, and the dropout rate also remained lower than expected. In Asia, the home market in Japan, with the efforts made by the entire company and the passionate commitment of the medical professionals, Lecambi is expanding ahead of the business plan. Next slide, please. Here in China. After Lecunvy was launched on June 27th, it has already been adopted by 148 hospitals in 57 cities across the country. First quarter result was 0.2 billion yen, and we started contribution to patient Mendi in private market. One of the characteristics of this region is that in addition to PET and CSF, we are introducing a pathway model utilizing new technologies such as BBBM, online platform, industry collaboration, On the online platform managed jointly by Azai and Jingdong Health, a Chinese company, where approximately 300,000 general consumers and about 1,350 AD specialists are registered. Through this platform, information regarding dementia specialists and infusion centers is provided, and also through reminders of the MRI tests for area monitoring through of all which an ecosystem where it is easier to participate in and continue treatment is being established. The number of people with READ in FI24 is estimated to be 17 million. Contribution to patients has been rapidly increasing in China, which may become the second largest market after the U.S. in the medium to long term. Launch has been started steadily. Next, please. From here,

I would like to discuss our efforts to develop Lakembi. We have spent more than 20 years to develop Lakembi, and during 19 months after its launch, from OLE study and various sub-studies, we have accumulated robust findings in this area, both in quality and quantity. Based on that experience, we believe that Lakembi's unique value has been demonstrated once again with even more data, namely, Early start of treatment and continuation of treatment after plaque removal maximize efficacy. Secondly, even in long-term treatment, the high level of safety is shown a thoroughly suggested effect on tau cascade. I would now like to turn to the latest updates from AAIC, the International Academic Conference held the other day to describe these unique points. First, these are the results from 36 months of long-term treatment with Lecambi obtained from CLARITY-80-OLE study. The top green line shows the change in CDR-SP in the group treated with leucanumab for 36 months. The bottom pink line is the change in CDSRB in ADNI cohort set as the placebo arm. OLE study, after the initial 18 months of core study, does not have a placebo arm. Thus, ADNI cohort data is used after 18 months. The two lines representing the difference in CDR-SP continue to separate from month 18 to month 36. This demonstrates the meaningfulness of continued treatment based on clinical symptoms. in OLE study, even in delayed start group that started to receive leucanumab only after the start of OLE, there is a clear difference between the placebo. However, in comparison to the difference in clinical symptoms between early start group and placebo, early start shows effects exceeding that seen in late start group. This data can also be considered to suggest the importance of early start of treatment. Leucanumab is the only drug that includes early MCI population who have small accumulation of tau or low tau group and also subjects who do not have tau accumulation or no tau group in its studies. This slide shows data suggesting efficacy of long-term treatment in no and low tau groups. In no or low tau group patients, after 36 months of administration, 59% as shown here, right side or left side. 59% was confirmed to have maintained CDRSP. Moreover, on this side, in 51% of the subjects, signs of improvement were confirmed. Looking at other indicators such as ADASCOG14 and ADCS MCI-ADL, similar results showing maintenance or improvement in CDR-SB were obtained. As shown here, in no-dow and low-dow groups, after 36 months of continuous treatment, consistent maintenance and improvement of clinical effects occurred. These are also important data showing efficacy of early start of treatment and continuation of treatment. This data shows the importance of treatment continuation indicated by the plasma biomarkers during the gap period. After the core study, there was a gap period before the OLE. During this period, there is no treatment and clinical symptom indicator, CDR-SB, is known to deteriorate, similar to that in placebo group. Left top graph shows that during the two-year period without treatment, plasma biomarker, A-beta-40-to-40 ratio suggested increasing trend of amyloid in the brain. but after the treatment was resumed during OLE, the trend was reversed and turned to decline. Similarly, plasma AD biomarkers such as PTAL181 at right top, GFAP at left bottom, and PTAL217 at right bottom also suggest reaccumulation trend during the gap period, confirming that the AD pathology started to progress once again. As shown here, AD pathophysiology related Plasma biomarkers are reaccumulating consistently when the treatment is stopped, and AD-related pathological process starts to progress again. On the other hand, after the gap period when the Kanemab treatment is resumed, it has been confirmed that biomarkers show declining trend, suggesting the importance of not stopping but continuing the Can-B treatment. This is data obtained from Clarity ADOLE showing safety in long-term treatment. As for the incidence of adverse events in Clarity ADOLE in exposure-adjusted ratio, it was equal to or lower than the core study, and no clear increase in adverse events was observed with long-term administration. so no new safety findings were observed. This indicates that in long-term administration as well, safety of leucanumab is high. I would like to once again touch upon the unique MOA of leucanumab centering around protofibrils. Leucanumab removes the plaques and at the same time selectively acts on protofibrils considered to be most neurotoxic. and protect the neural cell functions. This has been evaluated before and has been reported before. Furthermore, it is beginning to be understood that the protofibrils can be the trigger of the tau cascade in the downstream. And suppression of this leads to suppression of tau pathology Tau cascade starts with tau phosphorylation causing neurofibrillary targets, and the Kahneman administration led to results suppressing the progression of tau pathology observed with tau PET. Tau pathology-specific MTBR tau 243 increase is also delayed, which suggests the suppression of tau pathology. and therefore long-term clinical efficacy may be exerted. And once again, what I would like to reiterate is that protofibril may have clinical effect on tau cascade. The kind of unique MOA and deep insights on clinical effects will be presented with more detailed data at the key event seated in autumn this year. Lastly, I would like to show the key events scheduled this fiscal year. In the second quarter, data was presented at AAIC. As I have discussed thus far, we believe that we were able to show data that will maximize the value of Wekenbi. In the third quarter, at CTAD, plaque and protofibral contribution to clinical effect and real-world data related to long-term treatment for over five years are expected to be presented. In the fourth quarter, we expect approval of IV maintenance treatment in the U.S., and we would like to further appeal the long-term treatment benefits for the patients. In a head 345 study targeting preclinical AD patients, enrollment of 1,400 patients is expected to be completed before the end of this fiscal year, Every quarter in this fiscal year, through these key events, we will continue to create strong momentum to maximize the value of Lakembi. This is my final slide. As I have presented so far, Lakembi is unique in that it has dual-action MOA and has a vantage by starting treatment early and by treating over long-term and the advantage of long-term safety. These characteristics are demonstrated by very robust data. We will continue to demonstrate more evidence that will strengthen these characteristics. Based on these, we are very confident that Lekembe will continue to be the first-line therapy for early AD. During the 20 years of development of Lekembe and 19 months after its launch, we have been collaborating with and building solid relationships based on trust with the patients, their families, academia, healthcare providers in order to open a new door to AD treatment. AD is progressive and, in principle, irreversible disease. And as I discussed today, Lecambia treatment can be expected to be more effective with earlier treatment and long-term continuation of treatment, according to data. With that in mind, our mission is to deliver Lecambia to the patients as soon as possible, and we will do our utmost towards that end. And I ask you for your continuous support. With that, I would like to conclude my presentation. Thank you.

Now we would like to open the floor for Q&A. First, we would like to hear questions from investors and analysts, and then we would like to ask for questions from media. If you wish to ask questions, please mention your affiliation and name before asking your questions. Now, if anybody among analysts and investors, if you have any questions, please raise your hand. The person in the fourth row, please. Thank you very much. My name is Wakao from J.P. Morgan. I would like to ask about the Lecambi progress during the first quarter. Thank you very much. It is steadily growing, but in China, starting from quarter two, the sales started to be posted, which was quite surprising to me. And in America, although it is still growing, but not as in line with our expectation, particularly the current status in the U.S. Is it really progressing in line with the business plan of the company? If it is the case... at some point in the future, shifting from the linear growth, or there needs to be further accelerated growth. So when do you expect such a change or inflection point is going to be made? So if you are seeing earlier timing, please let us know. For the fiscal year, global results progress will be explained by Ms. Naito-san. And regarding the current status in the U.S., Haruna-san is going to explain. Thank you for your question. As I said in the presentation, from the global perspective, we believe that the Lecambi sales are steadily growing rapidly. And progress has been good. And also the growth rate is also being accelerated. That is how we take. And that is also represented in the reimbursement status. And we believe that this upward trend will continue. And I would like to ask Haruna-san to supplement my response. Thank you very much. I am in charge of Lecambi in the United States. My name is Haruna. regarding your question about the status of the business during the first quarter. In the United States as well, the progress has been steadily made in line with the plan, and also the breadth of the prescription and also depth of the prescription are to be expanded, which are very important for progress in the Canby. First, regarding the breadth of the prescription, The prescribers and the number of medical institutions where they can be prescribed is expanding and which has been steady growing over the planned and particularly about 40% of the new prescription recorded during the first quarter. Therefore, the recent start of the prescription is expanding. and directly appealing it to the patients and the families in order to encourage them to seek the medical consultation. DTC, or You Still Can Be, is conducted in order to expand the number of patients who will seek medical consultation. Therefore, we are starting to see the effects of digital marketing. And also, the number of medical institutions with over 50 prescriptions has increased by three times from the previous quarter and about out of which 70% of the medical institutions have become the larger center for a large number of prescriptions. For this, as Mr. Naito explained earlier, as the specialist in the neurology area, NASA who is providing information on the can be and also for the neurologist at the medical institutions. We are increasing activities and we are trying to establish that more than 100 medical institutions as a large prescribing institutions. And regarding the achievement of the target for this fiscal year, we are planning to see the big waves for each quarter. showing the long-term continued treatment as well as the early start of the initiation have shown the benefits for the Lekembe that was presented at the AAIC. And also, particularly from the long-term perspective, we needed to consider the treatment for the patient. We have got that feedback from the AAIC. And during the third quarter, their new biomarker, General Acting MOA, how it is important, will be presented during the third quarter. For the fourth quarter, the biweekly administration will be reduced in terms of frequency to a monthly administration, which will increase the convenience of the And there will be the indication, new indication for the... SCIV will be approved during the fourth quarter therefore it will enhance the convenience of the patients and we are establishing the pathway and also we are closely working with the healthcare providers and the CMS and the infusion center and advocacy groups and there are many stakeholders with whom we are discussing consulting and we believe that we have been able to establish a very strong relationship with them. So Based upon such data and experience and expansion of the indication, utilizing such great advantages, we are going to accelerate the expansion of the width and the depth of the prescription going forward. Thank you very much. On a monthly basis. As you have been showing us now, on a monthly basis, this linear expansion of growth will be made into an exponentially accelerating growth trajectory. We have expectations for that. And the second question is about the status in Europe. These 36 months are going to be submitted. Including this 36-month administration data, this CHMP's negative opinion that has been given, do you think that sufficient data do you hold in order to reverse this negative opinion of CHAMP? With this question, I'd like to call Dr. Linklema to respond.

Yes. Thank you very much. Let me discuss this CHMP recommendation. On July 26th, the EMA announced that it has recommended the refusal of marketing authorization for Lakembi after considering the balance of benefits and risk, as Kisuke Naito mentioned. ASIA understands that the ground for this refusal, however, is primarily safety. However, we would like to emphasize the incidence of ARIA in actual clinical settings is not higher than in the clinical trials and is being well managed in accordance with the guidelines set by each regulatory agency where it is commercialized. The protocol for the CLARITY-AD phase three study was determined in advance with health authorities as was mentioned. And the results in the trial were evaluated using evaluation criteria and analytic methods that were determined in advance. In this trial, Lekembe achieved its primary and all secondary endpoints demonstrated highly statistically significant results. Despite this, of course, we are disappointed that CHMP adopted a negative opinion. The efficacy of Lekembe have been sustained up to 36 months, and the long-term safety has also been established as shown in results at the AAIC in 2024. In order to provide this treatment to European patients as soon as possible for the treatment of this progressive and fatal disease, We will seek reexamination of this opinion and will work closely with the CHMP to seek early approval. LeCambie has been approved in six countries and several others we hope shortly will approve. And it has been proven that the benefits of LeCambie outweigh the risk in each of these countries. We firmly believe that as the best equipped and single treatment for this progressive and fatal disease, it will be made available to patients in the EU without delay. AD communities, such as patient organizations, are spontaneously writing letters to EMA, many, many letters. These activities include AD experts, patients and key opinion leaders from various parts of Europe, many parts. The European Commission regulations allow an applicant to request a reexamination of a CHMP opinion. Reexamination will be requested within 15 days after receipt of the official CHMP opinion in writing. The company will then submit the detailed grounds for requesting a reexamination within 60 days after receipt of this opinion. New rapporteurs will be appointed for the reexamination, and then EMA will have 60 days to review Azai's reexamination documentation We understand that the results of this reexamination will be issued within this calendar year. In order to provide this treatment to patients in the EU without leaving anyone behind for the treatment of the progressive and fatal AD, we remain confident in our robust data and we will work closely with the CHMP to receive early approval.

Thank you.

able to comment specifically on the regulatory aspects around APOE homozygotes. However, we will work closely with the EMA with the goal of trying to provide access to Lekembe for as many patients as possible. That's a question that we would have to discuss further with EMA. Thank you very much.

Understood very well.

Would there be any other questions? Yes. Audience member seated in the third row, please. I'm Hashiguchi from Daiwa Securities. I have two questions. First is about Rekembe, the current status of Rekembe. According to your presentation about Japan, dropout was lower than expected. That was mentioned during the presentation. Are you mentioning dropout only due to ARIA or dropout due to all reasons? And specifically, what was the expected level of dropout and what is the current level of dropout? I believe that after the start of the actual treatment, It has not been, much time has not elapsed yet, but that is the question. And this was on Japan, but if you have similar information regarding the U.S., could you share that information? Yusa will respond, and then regarding the U.S., Haruna will respond. Mr. Hashiguchi, thank you for your question. I am responsible for the Canby commercial. I'm Yusa. I will respond first regarding dropout and the specifics of the patients who dropped out. It is not limited to the reason of area for dropout. All side effects and all circumstances are taken into view, and dropout ratio was much lower than the percentage that we initially expected. But as you have rightly mentioned, It has been only quite recent that administration in actual clinical setting has started. But in the first six months, according to various drug data, there is a dropout ratio data for the initial six months. And in comparison to these data, dropout ratio can be said to be lower. About the U.S. situation, Haruna-san will respond. This is Haruna, responsible for the United States. As Yusa-san reported about the situation in Japan, similarly in the United States, including Aria, for all side effects adverse events. So far, the... incidents is about less than half of the incidents in Clarity AD and similar to what is described on the package insert. And in AAIC, some real-world data were presented. And if I may cite one example, Columbia University had 120 patients, and based on the experience of administering, there can be 120 patients report was presented. According to this presentation, area incidents and the continuation of administration in these perspectives, benefits exceeding clinical studies were achieved. And therefore, we believe that progress has been smooth in terms of long-term treatment. Low incidence of adverse events. What is your analysis of the reasons as to why adverse events incidence is lower? Is it because of different patient background between clinical studies and real world? Or is it because of a difference in monitoring of AEs during the clinical trials and the real world? That question will be addressed by Owa-san. Thank you, Mr. Hashiguchi, for your question. This is Owa speaking. I am chief scientific officer. Generally speaking, what the cause is cannot be concluded without a detailed analysis, and the point raised by Hashiguchi-san may be a possibility, but which is more important, We will have to observe more over a longer term of administration after real-world data is accumulated more. To specify potential cause will be premature, but we recognize the point raised by Hashiguchi-san is an important point. Second question about development strategy of more of 202 going forward. Asai announced that Asai will continue to develop more of 202, but it will be developing on its own. Is there any change to development strategy? Will Asai be exploring a new partner? Once again, Owa-san will address that question as well. Shikuchi-san, thank you very much for that question. This is Owa speaking. First, with BMS, we had a very close discussion. And because of the differences in strategies of development of portfolio, this partnership was ended. But we believe that there is a solid value in more of 202. And therefore, we will continue to develop. And in doing so, what becomes important is efficacy. In the past academic presentations and papers, I think you can see that there is efficacy. The issue is in long-term treatment, can we maintain QOL of patients? And is there going to be how can we control ILD? That will be a key issue. Clinicaltrial.com has certain information from which you are able to understand that we have four different schedules or administrative regimens. Intermittent administration or steroid co-administration, these are being explored, and we have accumulation of data recently. And based on these data, we are holding advisory board to consider what schedule we should follow in further development, and details are being worked out right now. And in the near future, through academic presentations, we hope to present how we plan to continue development under what administration regimen. And gynecological cancer, I think, will continue to be the focus for this cancer, since folic acid will be highly present. The clinicians' opinions will also be taken into consideration to determine our development strategy, and I believe in the near term we will be able to discuss that in more detail. Is there any possibility of partnering? I forgot to respond to that question. I apologize. We have not rejected a possibility of partnerships. We would like to continue to look at the additional data and would also like to pursue those possibilities as well.

So the person who has raised hand through online, excuse me, rather the person in the second row, Harta of UBS Securities. As regards to Lekembe, I have a question. Lili, Kisunda is going to be launched both in the U.S. and in Japan. And after approval, what kind of response have you heard from physicians and also frequency of dosing and efficacy and safety? And after a certain period, the donanim of dosing will be stopped? And what has been the response from the medical world? And I believe that Your accounts may have given you the positive response to you, but have you ever had any response you have heard? For your question, Naito-san is going to respond. Let me share with you some assumptions. We believe that the disease of amyloid AD or Alzheimer's disease is a progressive which will continue progressing even after plaque is removed. That is how we interpret it. So after turning the plaque into negative and then the dosing may be considered for stopping, the criteria and also the conditions of patients are not shown by data yet for Kinunda. And after participation in the AAIC, and atmosphere and also how we felt at the venue, can be shared with you by Haruna-san. Could you please report on how you felt at the conference? The response you felt from physicians at AIC in the United States, that will be shared with you by Haruna-san. Thank you. I am in charge of the Kenbi in the United States. My name is Haruna. Regarding the response at AIC, the 36 long-term data was presented at the Congress for which Many physicians recognize the importance of long-term continued treatment and also for Alzheimer's disease. Continued treatment is very important. That was the feedback from physicians and the difference between the drugs. are now compared and considered. And what is most important in our opinion is we have obtained a lot of knowledge. And since the accelerated approval, we have heard from many physicians and healthcare providers, and we collaborated with them to establish pathways And when it comes to this pathway, other companies are not able to use our pathway. Therefore, they need to start establishing pathways on themselves from scratch. And as far as we have heard from physicians, Lecambi will continue to be the drug of first choice, and the value of a long-term continued treatment and the significance of continued treatment are differentiating us conspicuously from the other. Thank you for your question. I understood very well. Thank you very much. For when the SC maintenance treatment is approved and among the existing patients, how big the needs for that SC maintenance treatment do you see? So regarding the needs of shifting from the existing IV to SC maintenance dosing, Haruna-san, who is in charge of the U.S., is going to respond to that question. Thank you for your question. My name is Haruna. I am in charge of Lekembe in the United States. First... The needs for SC. I would say that there has been a great expectation at the AAIC conference. There were lots of questions and a lot of expectations in the Q&A session at the Congress meeting. When is it going to be approved and how you are completing the submission and so forth. Many questions were asked. And IV therapy and SC therapy will both become available in the future and in accordance with the lifestyle of patients, patients will be able to get more flexibility. So for SC administration, they may be able to administer at home and that will give a great benefit for patients. Thank you for your question. Thank you very much.

Next attendee who is participating online. Yamaguchi-san from Citi, please. Please unmute. This is Yamaguchi from Citi. Can you hear me? Yes, we can. Thank you. I have one question. This is to clarify what Dr. Lynn Kramer was explaining earlier, which is about Legambi in Europe. Within 15 days, response will be submitted. And I may have missed this. Within 60 days, review will be carried out. 60 days, meaning that in two months' time, review will be carried out. So the timing is very clear. Am I mistaken? Could you clarify that once again? Lynn Kramer will respond.

Yes, thank you. It actually is a four-month period. After we receive the formal letter, we have to respond in 15 days that we would like reexamination, a formal response. We will then receive the list of questions that the CHMP and EMA have. We then have 45 days to respond to those questions. And then there is a 60-day period for EMA to identify new rapporteurs and for preparation and review of those materials. And then there will be a new oral explanation at that point. So it's four months from now, approximately. Is that clear? New rapporteur, meaning new reviewer. Two. So in a re-examination, EMA needs to appoint new reviewers, and there are two, one from one country and one from another country.

Thank you, that is all.

Any other questions? The person in the fourth row, please have the floor. Asuna of the Yomiuri Shimbun. Thank you for this opportunity. I would like to confirm with you the current status in Japan. The number of patients who are on this treatment cannot be shared with us because this is based on the guests. But during the court Q3 for fiscal year 2023, when you had a financial briefing, 3500 people by the fourth quarter and also the 7000 will be the target for this fiscal year. So are you in line with this target or exceeding this guidance? Could you please share with the current status? The sales of vials have been shown this time, but What has been the volume of shipment so far? Could you please share with us? Yusa-san is going to respond to your question. Thank you for your question. I am in charge of a Rekinbi commercial site in Japan. I think you were talking about number of patients, but regarding the specific number of patients who are on treatment, we are not able to give you the number, but I can say that we are in line with the target or rather we are ahead of the target.

Are there additional questions? we have run out of time unfortunately we would like to conclude today's earnings results presentation session if you have further questions please contact investor relations thank you very much once again for taking your time today