Eisai Co., Ltd. (4523) Earnings Call Transcript & Summary

It's now time. We would like to begin financial results presentation on fiscal 2019 results. Because of COVID-19 infection situation, today we are live distributing -- streamcasting the financial results presentation. I would now like to introduce the presenter today, Representative Director and CEO, Mr. Haruo Naito. Without further ado, I would like to -- I'll give the microphone to Mr. Naito.

Naito speaking. Now I would like to give you a presentation on the financial results for fiscal year 2019. Please look at the slide. Given the current circumstances surrounding COVID-19 pandemic, we are a pharmaceutical company. Therefore, we believe that there are many roles that we should play, out of which, I think, what is most important is described on this page, which is stable supply of our products. Needless to say, each pharmaceutical product is leading to quality of life or lives of patients. Therefore, these are all life-related products. Therefore, the discontinuation of supply is not allowed. On this slide, we are globally rolling out manufacturing at 9 sites over the world. On the right-hand side in table at each manufacturing site, the state of emergency issuance is different among different manufacturing sites. But currently, at all 9 sites, operation is smoothly ongoing. Therefore, stable supply of our products have been secured. To maintain stable supply, as we have described at the bottom of this slide, we needed to have sufficient supply of raw materials, API or intermediates or packaging materials. These have to be kept in ample stock. To continue our manufacturing activities, such BCP, business continuity plan, is necessary. Currently, for our main products, on the average, we have ample stock of final products amounting to 4 months to 5 months of stock level. Needless to say, another important point is at manufacturing sites, of course, we have employees who are operating the plant. We needed to secure the safety of them. We have manual -- internal manual for COVID-19 is utilized in order to implement, in fact, rigorous infection control measures to secure safety of employees. Another role to be played by us is to develop treatments and vaccines for COVID-19. From that perspective, today, first of all, we'd like to share with you the possibility of eritoran, E5564. Eritoran, as you see at the footnote #1, which is a structural analog of lipid A, which is an activator of endotoxin of bacteria, you can see chemical structure scheme of this compound for the sugar chain. And this was a treatment which was in-house synthesized at Eisai Research Institute of Boston with an aim to get approval of this compound for indication of severe sepsis we conducted until up to Phase III trial. But in 2011, this development of eritoran was discontinued. E5564, or eritoran, will be studied in hospitalized patients who tested positive with COVID-19 and have worsening symptoms. On the right-hand side, mechanism of action and schema are described. The target of eritoran is found at upstream of cytokine gene expression signaling. The target is TLR4. So this is a TLR4 antagonist. At the very upstream of this cytokine gene expression signaling will be inhibited. Therefore, downstream IL-6, TNF-alpha, IL-1 beta, various cytokines production will be inhibited. So eritoran is going to be tested for indication for certain groups of patients who tested positive with COVID-19. In the lower bottom left corner, you will see the description of how we are working on this project. In the U.S., there is an international network called REMAP-CAP-COVID for repurposing of drugs. Various multiple drugs are being tested within this framework, where we have participated to explore the possibility of eritoran. Starting from June 2020, global randomized, controlled study will be initiated at domestic investigational sites. In order to prepare such sites, we are making necessary coordination. These investigational drugs are being under preparation with good quality and about 400 subjects to be enrolled in this randomized, controlled study. If everything goes well, at the end of -- around the end of this year, we'll be able to get the result out of the study and -- although the second wave and third wave of infection are anticipated, but there will be possibility to address those second and third waves of infection. Through countermeasures against NTD, neglected tropical diseases, we have been engaged with Bill & Melinda Gates Foundation for many years. In relation to that, the Gates Foundation is taking a central role in the development of vaccines for COVID-19. As you can see in the bottom left corner, an immunologic adjuvant, E6020, which is already used in practical use, this was internally developed and discovered at Eisai Research Institute of Boston, which we may pursue the possibility as a vaccine. And The Scripps Research Institute is leading the initiative called pandemic response library, where Eisai's very unique natural products compound library has been already provided as regards to the development of treatment. On the right-hand side, what has been already licensed out to Roivant Sciences, which is gimsilumab, which is a monoclonal antibody in Pennsylvania, Exton, former Morphotek site, has originated this antibody, which is anti-GM-CSF monoclonal antibody. For ARDS, or acute respiratory distress syndrome, Roivant Sciences has initiated trial. Utilizing our site at Exton in the U.S., we are providing API for this investigational agent. Supporting stakeholders. That is described on this page. In Japan, under the hhc concept, we are collaborating with various groups and associations and organizations so far, for example, at the top, with local governments or medical associations. In total, there are about 167 associations with whom we have formed the partnership agreement for dementia. The second bullet shows the 4 groups of Living Labs. And the patient support groups and patient family advocacy groups over 100 groups as such in the area of dementia, cancer, epilepsy and sleep disorder. With 300 groups in Japan, we have prepared masks or relief goods and providing support goods to these groups. In the U.S., Europe, China, Asia and Africa, we are providing funding, for example, to provide PPE or providing support for the frontline health care professionals. In China, we are -- we have donated donation contribution to Wuhan Charity Federation in China. Given these initiatives, now we would like to present to you the summary of the consolidated statement of income for fiscal year 2019. Please look at the right-hand side. The characteristics of these results are described in the headline. Operating profit was JPY 125.5 billion and profit for the year was JPY 122.5 billion. The profit for the year attributable to owners of the parent is JPY 121.8 billion, ROE is 18.6%, all of which have been the record-high numbers. In the past, for fiscal year 2010, operating profit reached JPY 113.1 billion or ROE reached 16.4%. But all these numbers exceeded that number in fiscal year 2010. Revenue was JPY 695.6 billion, up 8% year-on-year, which will be explained in details later. This was driven by global brands, our proprietary brand drove this growth. And the cost of sales due to the mix improvement, given the growth of our in-house developed product, cost of sales ratio in the sales improved by 3.4 percentage points. Gross profit grew by double-digit rate. And R&D expenses were 97% of the previous year on this statement of income. However, including partners' reimbursement, R&D expenses were JPY 203.7 billion, which was up 6% from the previous year. We are one of the most proactive pharmaceutical companies in terms of investment in R&D among global peers. SG&A expenses. Given the expansion of the business in the previous year, the SG&A expenses grew 12% year-on-year due to the expansion of the shared profits with partners. And operating profit was up 46% year-on-year to reach JPY 125.5 billion and profit for the year was 84% increase from the previous year to JPY 122.5 billion. At the very bottom of this page, net DER, minus 0.29 in terms of financial robustness. Therefore, net cash position was secured. The debt-free management has been maintained. In the meantime, free cash was exceeding the JPY 60 billion, therefore exceeding the amount necessary for paying dividend. Ratio of equity attributable to owners of the parent, or equity ratio, is -- was 63.8%. Given any circumstances, we can say that we have very robust financial structure, which would not be affected by any circumstances, I would say. Here is the breakdown of changes in revenue. On this graph, as you see, the biggest factor for increasing the revenue was expansion of global brands. There was an increment by JPY 53.2 billion. And what has been obtained from the business in the previous year, that is to say, milestone payments, were recognized, increasing the revenue by JPY 10.6 billion. Given the success the business recorded in the previous year, that was the main driver for the increase in revenue this year under review. Regarding the LENVIMA-related payments, all milestones -- preset milestones were cleared. Therefore, there was milestone payments in the amount of JPY 10.6 billion. And given the transfer right for the -- transfer of the shares of the Elmed Eisai, there was a negative factor and transfer rights for tazemetostat and the milestone payments were recognized. Therefore, there was an increase by JPY 14.1 billion, an increment in total was JPY 52.8 billion year-on-year to reach JPY 695.6 billion. Next, breakdown of operating profit migration. The factors contributing to the changes were almost similar to what we saw with revenue and increase of shared profit of LENVIMA paid by Eisai recorded minus JPY 25.5 billion. This was all due to the expansion of LENVIMA business. Therefore, shared profit paid to partner was increased. Therefore, we believe that this is a proactive increase in the expenses. And the operating profit was increased by JPY 39.3 billion year-on-year to reach JPY 125.5 billion, which was a record-high. On the right-hand side, you can see the R&D expenses. Please look at the column for FY 2019, JPY 140.1 billion, which was recorded on the P&L. Adding JPY 63.5 billion as the reimbursement from partners, that total JPY 203.7 billion was the actual spending in R&D activities, which accounts for about 29% of the revenue compared to the previous year, which was up 6% from a year earlier. Now turning to LENVIMA. For fiscal 2018, 2019 and 2020, over the 3 years, we have seen a steady and dynamic growth over the years. For the current year under review, revenue was JPY 158.0 billion, which was 41% year-on-year. In the current fiscal year, we are aiming at achieving this. On the right-hand side, Americas, for hepatocellular carcinoma and the combination therapy with KEYTRUDA for endometrial carcinoma, for these indications, developments are being ongoing. And the first-line HCC indication, we are preparing for the launch for this indication, which is currently under review in combination with KEYTRUDA. Another important market next to Americas is China for LENVIMA as well. New patient assistance program has been introduced. And the number of patients has increased by about 60% from a year earlier. And regarding thyroid cancer indication, launch readiness is being progressed. In Japan, EMEA, Asia, Latin America, endometrial cancer and HCC, the number of countries where these indications have been approved and launched is to be expanded in order to achieve this JPY 158 billion for the year. For LENVIMA, there have been the guidances recommending this LENVIMA use from various societies. And given this COVID-19 infection risk, oral formulation cancer agents are being recommended. For example, from ILCA, International Liver Cancer Association, issued guidelines -- guidance to recommend oral formulation. And the second one, LENVIMA used to be classified as category 2 but now recommended as category 1. For RCC, the oral formulation cancer agent has been recommended by issued guidance. And LENVIMA, everolimus combination therapy is recommended. For endometrial carcinoma, in combination with KEYTRUDA, rather than every 3 weeks but every 6-week administration is recommended. Therefore, combination therapy of LENVIMA and KEYTRUDA has been increasingly selected. And the benefit of administration of LENVIMA's oral formulation is being enhanced, given this risk of infection. Conversion treatment is something that I've reported on past occasions. In hepatocellular carcinoma, when tumor volume is large in patients and it is Barcelona B Classification patient, first, LENVIMA can be administered to shrink the tumor volume. And then curative treatment, such as TACE, may be utilized to achieve cancer-free status in patients. And that is conversion treatment. In Japan, which is one of the most advanced countries in hepatic cancer treatment, TACE and other curative treatment have been developed and such -- correction, conversion treatment has been developed. And the combination therapy with LENVIMA allows for such conversion treatment. Study 307, Study 309 Phase III studies are underway for combination therapy of LENVIMA and KEYTRUDA. And as for the studies listed here, enrollment of target number of patients has been completed. For Study 307 and Study 309, close to 1,000 patients have been enrolled. And we will make sure that we will make close follow-up of patients and would like to make sure that there will not be a delay -- substantial delay in the conduct of the trials. We will work with Merck to minimize negative impact of COVID-19 by working together and by working flexibly. I would now like to discuss the topic of neurology area. First, DAYVIGO. This is lemborexant orexin dual inhibitor. In Japan and the United States, approval conditions were all satisfied and it is now ready to go. Once again, orexin biology is shown in this slide in the upper part of the slide. One of the most prominent researchers in Japan, Dr. Yanagisawa had conducted ligand hunting for orphan GPCR. And this is known as the most successful result. Orphan GPCR HFGAN72 ligand was discovered to be orexin, as shown in the middle of the slide. And orexin is a very important substance that controls sleep and wake cycles according to Dr. Yanagisawa. And at Tsukuba Research Institute, library was built. And as a result, we were able to obtain receptor E2006 or lemborexant. There were 2 large Phase III studies, compared to placebo and compared to zolpidem ER in older patients. In these 2 large Phase III studies, very good results were obtained in sleep latency and quality of sleep. And in 2 healthy subject studies, residual next-morning effect was observed. This is the third blue triangle, and this is reflected in the package insert in the United States. As a result of the 2 studies, in comparison to placebo, there were no meaningful differences in next-day postural stability. So sleep latency, quality of sleep and residual next-morning effects in all of these 3 areas, treatment is achieved by DAYVIGO. We are now preparing to launch DAYVIGO. Under COVID-19 situation, information communication with the traditional method of medical representatives visiting institutions will be difficult. So as shown at the bottom of the page, we will be centering around digital-centric strategy, including web seminars, digital meetings and remote communication. Centering around digital means, we would like to launch DAYVIGO. We are preparing for launch in June timing in the United States and around July timing in Japan. Now turning to aducanumab. Towards completion of submission, we are making good progress. In the United States, we now have open BLA and have started to submit modules of the filing. This regulatory filing process, in this process, we are making good progress in open BLA submission modules of the filing. And for that, pre-BLA meeting has been scheduled. Therefore, we expect to complete the filing in Q2 fiscal 2020. We have a very good visibility of that. And at the same time, in Japan and in Europe, we are engaging with regulators. Together with Biogen, Eisai is engaging in very strong collaboration with Biogen. And we are starting to make full-fledged preparations to deliver potentially first therapy to reduce clinical decline in Alzheimer's disease patients. About BAN2401, final regulatory requirement, Phase III study, Clarity AD, is in the stage of enrolling patients and progress had been made so far. However, because of COVID-19 impact, the pace is slightly slowing down. However, sites in China will soon initiate enrollment and the impact may be such that additional 3 months may be required. Final readout timing is changed from Q1 fiscal 2022 that we announced previously to Q2 fiscal 2022. As for earlier phase of AD, preclinical AD, we have Phase III study AHEAD 3-45. And we are about to be ready to start the study. Home infusion at patient home or assessment to be conducted remotely, these are measures that are being encouraged by the regulators. We would like to make active utilization of these methods to mitigate the impact of COVID-19 as much as possible. Today, regarding BAN2401, I would like to discuss 201 study, which had already been completed. This is the core study. And at the bottom of the page, the situation of OLE study is described. Of course, 201 study is parallel group comparative study. ADCOMPS is used to measure the slowing of progression of the disease. And various background biomarkers are measured. And slowing of pathophysiological progression was observed through the observation of these biomarkers. And we believe that these support for efficacy clinical symptoms. As for OLE study, after the end of the core study for 2 years, after the end of the randomized study, there is discontinuation of about 2 years. And this is the baseline for OLE study. CDR-SB is used to assess cognitive function. Between active arm and placebo arm in the core study part, there were differences in clinical symptoms. And that difference is maintained over this discontinuation period. The gap between the 2 arms is maintained. That is what this data suggests. On the right side, in the first bullet, this is described. When disease modifying effect was demonstrated by a drug, it is considered that suppression of cognitive decline versus placebo continues after administration of drug was continued since neuropathy is reduced. This is one of the strong data suggesting disease-modifying effect. In the middle, for your information, our key drug Aricept data is shown. On the right side, at the end -- after the end of the core study of Aricept, after 6 weeks of discontinuation, cognitive function deterioration in active arm was such that the level declined to the same level as placebo arm. And this is the difference between symptomatic relief and disease-modifying drug as we see it. And that is why I am sharing with you this information on this page. Earlier, about second-generation -- next-generation Alzheimer's disease drug treatment, I have mentioned that we have started full-fledged effort. And one of the important efforts as a part of that is dementia platform easiit. We have registered the name easiit. easiit dementia platform is shown at the center. And this uses smartphone app. easiit core asset includes Aricept accumulation of AD treatment experiences, AD is also included. And based on external cohort and high-quality data, analysis is carried out and advice can be given as a result of utilizing data. And that is the most important core asset. Using that -- in order to use this asset, on the left side in daily living domain, to consumers, to patients -- or from consumers, from patients, personal health record can be collected, including data on sleeping, data on walking, data on diet. And from April, to providers, sales of NOUKNOW has been started. NOUKNOW is a digital tool, which allows for convenient checking of cognitive function. And through this, personal health record can be collected. And we will be applying our AI to analyze data. As shown in the arrow on the left at the bottom, we can return the information to make a recommendation of preventive action so that people can practice such action. We would like to encourage people acquiring a habit of practicing such preventative action. On the right side, in the medical domain, medical data is collected by various medical institutions, including blood test results and medical version of NOUKNOW, Cognigram data. Cognigram uses same algorithm to measure brain performance. Such information can also be input into easiit through medical chart, through medical version of the app. Using AI algorithm, treatment effect can be visualized and side effect detection can be assisted. Such information can be provided. And this will make easier realization of optimal treatment and will also assist in conducting efficient interviews and diagnosis by doctors. So in daily living and in medical area, data can be crafted. And they can be connected and combined on the platform of easiit. One more thing I would like to discuss about easiit is chasms that I also discussed in the information meeting. Chasm is the gap in disease understanding or barriers that must be overcome so that preventive actions become common practice. These gaps are chasms. As noted in the footnote 2, and at the left part, it shows that total population is about 66 million. Often, smaller number of people understand the disease, 44 million. And people who have acquired common practice of preventative action is even smaller in number, and people who have a common practice of checking cognitive function is even smaller. These are the chasms. And in medical domain, on the right side -- as shown on the right side, convenient diagnostic tool, whether it is prevalent, used frequently or biomarkers usage, the number of population is even smaller. And monitoring of administration side effect, there is even bigger chasms. In each chasms stage, easiit can be used to reduce and eliminate chasm regarding the lack of understanding of disease. People between the ages of 40 to 50, we can offer content that we develop jointly with influencers through easiit to educate people on the disease. As for the lack of convenient diagnostic tool or -- we would like to provide NOUKNOW. And regarding PET test, CSF examination, easiit can provide information about the utilization rate of these equipments in institutions and offer information of that. And easiit can also help build a network for better cooperation regionally by using easiit. As shown at the very bottom including cognitive checking, lifestyle can be improved, and smooth diagnosis and treatment of dementia can be realized more easily. That is what we would like to achieve. This is my second from last slide. COVID-19 may bring a new order or as people often call it, new normal. We are facing COVID-19 situation, and we were made to realize that there were 2 principles: first is that human life comes first, and the second is that individual countries cannot stand-alone. If -- even if one's country is okay, if the others are not okay, that is not a good situation. And in this situation, one of the most important keyword is digital transformation. Here, digital and personal should be utilized in combination. New way of communication including easiit on the digital platform, we are able to have direct 2-way communication with many patients. And our field force sales activities can use digital in combination with in-person activities. And in medical care delivery, it is already happening -- some changes are already happening, including online medical consultation. And remote medicine among health care professionals can be further promoted even in remote areas. In African countries, apps may be utilized to understand disease prevalence. On the right side, there is a box with the title New Logistics. I discussed a stable supply earlier. Climate change will continue to be a problem, and we do not know what we will have as next pandemic. There will be natural disasters. Market may grow or shrink. With AI, we can make forecast. In raw materials procurement to production plan, we are able to better execute this. Global enterprise resource planning should be promoted. And as shown in the next bullet, from intermediate raw material to final product, manufacturing, more on a regional basis rather than depending on global network, may become more necessary. And new life-related policy business -- and businesses is the right bottom box. It is not only pandemic. AMR and Neglected Tropical Diseases can become a major problem and disease for the whole world. We cannot become complacent and therefore, we have to enhance problem-solving abilities in low-income populations and countries. For example, Universal Health Coverage or UHC benefit level improvement is one of the things that we have to seriously address. And in regulatory approval system, priority review system should be flexibly used in broader scope as people are discussing this issue right now. This is the PL for the ongoing fiscal 2020. JPY 719 billion is the forecasted level of revenue, 3% up from the previous year. So we expect continuous growth in revenue. And therefore, we will be making expenditures including milestone payments. And LENVIMA, JPY 154 billion of product sales including milestone revenue. LENVIMA business alone will be achieving revenue of JPY 250 billion -- or is achieving JPY 250 billion. It has grown into a very big product. And with the mix of in-house product, we will have a better situation, and we will achieve a growth in gross profit. As for R&D expenses and SG&A expenses, the input of resources -- investment of resources, this is for the investment into the future beyond EWAY 2025 into EWAY future. BAN2401 aducanumab, these AD-related diseases, for both of these, we will have large-scale studies, and we have large-scale studies. And LENVIMA shared profit partners will be increasing. And we also have to prepare to make contribution to patients through next-generation dementia drug. And therefore, we also plan to make investments in these areas. It is now the time to make these investments. And therefore, operating profit is forecasted to be JPY 88 billion; profit for the year, JPY 67 billion. Return on equity is 9.7%. According to the forecast, equity spread will be ensured in this fiscal year. As for dividend per share, it is noted at the bottom line at the Board meeting earlier today, year-end dividend of JPY 80 was approved. And for fiscal 2020, we expect to pay annual dividend of JPY 160. And with this, I conclude my presentation on fiscal 2019 results. Thank you for your attention.

Now we would like to open the floor for Q&A session. [Operator Instructions]

[Operator Instructions]

[Operator Instructions] The first question is from Citigroup Securities, Mr. Yamaguchi. The floor is yours. Are you ready, Mr. Yamaguchi? Can you hear? Yes. We can hear you.

My name is Yamaguchi, I'm from Citigroup. My first question. Well, first of all, eritoran, which I have heard after a long interval, data will become available by the end of this year and in development -- rather than development and the sales for the future. Is Eisai leading initiative of sales or this network will be leading the initiatives in future sales? Which is the case?

Naito speaking. Mr. Yamaguchi, that point is yet to be considered. Now quality of this investigational drug is being secured, and we are making utmost efforts to provide the drugs to the frontline. We are trying to speed up the clinical trial as soon as possible. That is what we are working hard. But if everything goes well and the commercial production shall be accelerated proactively, of course, we would like to see Eisai taking initiative. But when it comes to specific framework for commercialization, which, I believe, is yet to be determined.

Understood. Second question is about aducanumab. Let me clarify one point. It's a open BLA or rolling BLA, I think that is the submission made module by module. And after completion, then review process will start. That consensus in the United States, do you think that there is a delay? Or the play BLA meeting itself, there may have been any negative impact to that process or if there have been any reshuffle of the person in charge at FDA, I think there are certain uncertainties. And I believe it's difficult for you to make any counterargument under this situation. But from your gut feeling, what is your take once completing this process? And then do you think the development afterwards will be visible?

For this point as well, it is related to regulatory filing and the timing of getting approval all to be up to discretion of the regulatory authorities. Therefore, we are not in a position to make any comments on that. But we're thinking about the usual range if the delay is contained within that normal range or some minor hedges. I believe that those are contained to the minor ones. For the fundamental core structure of the processes, we believe that these have not been swayed by this situation at all.

Understood. My last question is about LENVIMA LEAP study. Those [ 116 ] has been submitted after immediately. And since the inception of the study, until the filing, there have been several studies where the filing process was very speedy. Do you think that this stance approach will be continued and repeated for LEAP study?

Thank you very much. From Oncology Business Group, Dr. Owa, who is in charge of Science, is going to respond.

Dr. Owa speaking. Mr. Yamaguchi, thank you for your question. Among LEAP study, I believe that what will be designated as a breakthrough therapy in the United States. If there are any potential, we would like to pursue that process together with Merck. Of course, we are not have a preconception regarding any specific types of cancer, but the universal benefit is expected from this combination of LENVIMA and KEYTRUDA. Therefore, we believe that such breakthrough therapy designation can be utilized in order to pursue the faster track approval. That is my answer.

We have Mr. Hashiguchi from Daiwa Securities. Mr. Hashiguchi, please.

This is Hashiguchi speaking. I have 3 questions. First is about LENVIMA 116 study about a first-line indication submission of HCC. When was the submission made? And in the forecast for fiscal 2020, approval of first-line therapy for HCC is reflected in your forecast for increasing revenue. Do you also have any expectation as to when it will be approved? And in the United States, I think the LEAP study results will have to be weighted. But I understand the target subject number enrollment has already been completed after the end of 3. And when will submission become possible in regions outside of the United States?

Thank you very much for your questions. Dr. Owa will once again respond to the questions.

Mr. Hashiguchi, thank you for your question. This is Owa speaking. First, regarding 116 study and submission timing and approval timing based on that study, right now, FDA is -- it is under review by FDA. And therefore, we are not in a position to say when that is going to be as a company. However, a public information will be available. ASCO virtual presentation will be made and abstract will be made public at 6:00 a.m. Japan time tomorrow. And 116 for 52 -- for Keynote 524 study abstract will be published. And I think you will be able to get a better flavor after analyzing that data. Then turning to your second question. LEAP-002 study Phase III study, it was shown in the slide, enrollment is complete. The endpoint of this study is OSNPFS, Overall Survival and Progression-Free Survival. Event-driven data cutoff, top line result timing -- top line results timing and data cutoff timing will be determined in event-driven fashion. If the drug is effective, it will be later in terms of timing. However, because of the sample size, it is not expected to take too long a time.

One more question, Phase III study of BAN2401 and COVID-19 influence on that, flexibility will be enhanced by utilizing digital media. What exactly do you mean? And endpoint can be achieved or not in the end and usefulness of this drug assessment may be affected by data quality, but will data quality be compromised as a result of using remote assessment?

Thank you for your question. From the United States, Ivan Cheung will be responding to your question.

Hello. This is Ivan Cheung speaking. Thank you very much for the question. With regard to digital and remote technologies, we are deploying a number of methods. As you mentioned, for example, during the outcome assessment timing, we would be able to do that remotely. Of course, we are going through significant training with the appropriate individuals conducting these assessments as well as the patients and caregivers and the sites to make sure that these assessments are carried out in very high quality and appropriate manner. And what I would say is, for us, the most important element of this trial is exactly the data integrity and data quality as well as patient safety. We will do everything in our power to make sure that the quality of this single pivotal study continues to be very high. At this moment, we have very good confidence. We are not saying that the COVID-19 situation is easy to deal with. It is a challenging situation, but we have confidence in ensuring data integrity and data quality. Thank you.

Mr. Hashiguchi, does this address your question? Thank you very much. Time is pressing, so I need to call the last person to ask a question. From Crédit Suisse Securities, Mr. Sakai. Mr. Sakai, are you ready?

Yes. I don't know whether this is going to be a question. But this time, on Page 16 of your slide deck, this data that you have shown us today, CDR-SB, the BAN2401 data, have you already engaged in discussion with the regulatory authorities? And I think that is the data that has been already published in CTAD, therefore, you have started engagement. I don't know. I'm going to pick up -- but ADAS-COG is of Aricept. I don't know what is the relevance in terms of science in comparison of this data against the Aricept ADAS-COG. So for what purpose have you used this data today? Probably this is merely just one indicators -- one of the indicators. But sorry, I wanted to confirm what your intention was.

Well, thank you very much, Mr. Sakai. Naito speaking. Your question. Well, I think you touched on -- set a fire on my emotion by your question. Aricept has been a very important flagship drug for us. As you know that Aricept has grown today's Eisai. So the performance of Aricept was shown with the proprietary data dedicated to Aricept considered -- showing the improvement of symptoms in terms of the difference in the clinical symptoms with disease-modifying therapies. That was my intention. We are not trying to compare the data. Of course, background and the design were totally different between the different studies, but both were conducted based on the robust protocols. So data were taken from such studies. So we wanted to show such difference between Aricept and the disease-modifying therapies in terms of the gap in clinical symptoms. Have you understood?

I think I understand this. So I -- that's why I said that I am cherrypicking or picking up your fault. And that is the current situation with Biogen. And without interim analysis in the first quarter of fiscal year 2022, you are going to continue this program. And 300-milligram in the U.S. is touched upon briefly, but have you ever considered any changes?

No. Currently, there hasn't been any change.

Thank you, Mr. Sakai. With this, we would like to close the financial results briefing session for fiscal year 2019 of Eisai Company Limited. Thank you very much for bearing with us for a long time. Thank you for your continued support. [Statements in English on this transcript were spoken by an interpreter present on the live call.]