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

Hello, everyone. Now we'd like to start Eisai's conference for media and investors. Thank you very much for joining today out of your very busy schedule at the beginning of the new year in spite of the short notice. Today, Japan time and on January 6 U.S. time, treatment for AD, lecanemab, or LEQEMBI as its U.S. brand name was granted accelerated approval for U.S. FDA. This morning at 4:30 a.m. JST, we issued a press release related to the accelerated approval and the statement on our U.S. pricing and the rationale behind, and LEQEMBI safety statement from the Global Safety Officer. At 1:30 p.m., we filed a partial change application from the accelerated approval to full traditional approval. In this conference today, we'd like to explain our thinking behind the pricing for LEQEMBI. Today's conference is organized, both on-site and online in a hybrid fashion. We thank on-site participants for wearing their face mask to prevent COVID-19 infections. Those joining on site can find in your handout 4 takes of documents, including a release and statements and the supplemental materials for the presentation today, so please check the handout. Those joining on Zoom can refer to our website to see the supplementary materials posted on our website for your reference. Today simultaneous interpreting is available between Japanese and English. Let me introduce the presenter today: Director, Representative Corporate Officer and CEO, Haruo Naito. We will start the presentation but we are keeping sufficient social distancing. Please allow him to take off his mask during his presentation. CEO Naito, the floor is yours.

Thank you very much. I'm Naito. As was just introduced, now with regard to the product LEQEMBI that we have been able to receive the accelerated approval by U.S. FDA. Based upon that, in the week of January 23, we are planning to launch the product in U.S. And also, on the day of the Accelerated Approval, again, we have been able to achieve the submission aiming at the full traditional approval in the United States. So based upon this context, and we have decided on the price of the product in the U.S. market. And on this occasion, I would like to explain the rationale behind this. So please refer to the headline of the release. So Eisai's approach to U.S. pricing for LEQEMBI, U.S. brand name for lecanemab, a treatment for early Alzheimer's disease, set forth a concept of societal value of medicine in relation to price of medicine. So as I will state later on, as the societal value of medicine, $37,600 is being said. However, we set a price at $26,500. And another important statement is that, as indicated in the subtitle, we are trying to pursue the maximization of the value for all stakeholders, and at the same time, we want to give back this societal value back to the society. So these are the fundamental basic concept behind our pricing policies. And that is indicated in this -- title of this press release. So I would like to read out this news release. And then furthermore, I'd like to give some additional remarks. Based upon our corporate philosophy of hhc concept, Eisai is committed to improve patients' health outcomes and quality of life and to simplify the care delivery and to increase the health system efficiency and spur future investment in Alzheimer's disease. This time, in the United States, we have received Accelerated Approval for LEQEMBI as an early AD treatment and for which -- with regard to the value evaluations and pricing, and we wanted to maximize the values for all stakeholders, including patients, families, caregivers, health care providers, payers, employees and shareholders. These are all the stakeholders that we have. And to all of these stakeholders, we want to find a way to try to maximize the value. And to the center, we are applying the very holistic approach. And so there are 3 values to this clinical values as well as the societal values. That is the benefit that we deliver to patients and families and caregivers and also the economic values that we offer to the societies through the reduction of the health care services needs and also the global burden of the disease to be reduced. And also, we want to make sure that we can contribute to further enhancing the innovations in AD. So these are the values that we are pursuing here. Now social impact of AD in the United States. Now third-party group. According to the Alzheimer's Association, came up with the statistics, and I would like to refer to that here. In 2022, estimated 6.5 million Americans age 65 and older are living with dementia due to AD including mild, moderate and severe dementia stages of AD in year 2022. And AD was listed as the sixth leading cause of this in U.S. in 2019. But right now, it is the serious leading cause of this because of COVID-19 pandemic. It is a chronic and progressive, and this is actually disabling and fatal disease. And according to another report from the Alzheimer's Associations (sic) [ Alzheimer's Association ], should there be no treatment that exists to delay the AD's disease, then the total cost of care in the United States from all payers, including Medicare, Medicaid, out-of-pocket and other payers would increase from $267 billion in 2020 to $451 billion in 2030. And according to this 2020 study, as many as 10 million to 14 million Americans living with MCI, I talked about 6.5% that is the AD populations, but now I'm talking about mild cognitive impairment populations. And out of this populations, 55% of them have AD, that is MCI due to AD'ed patients. So in this study, it is estimated that if a treatment that can slow the progressions from MCI to mild or mild to moderate dementia by as much as 30%, and it should result in the lifetime value of $134,418 per person in the United States. So this is the kind of context I would like to bear in mind. And then based upon that, I would like to go on to discuss the value of LEQEMBI adoption in the U.S. society. LEQEMBI is the treatment of AD. And as seen in the clinical trial, the treatment with LEQEMBI should be initiated in patients with MCI or the mild dementia stage of AD after confirmation of amyloid beta pathology, that is early AD patients. And in the United States, we estimate that such diagnosed and eligible early AD population indicated for AD-DMT, disease-modifying therapy, should be reaching in 3 years' time approximately 100,000 individuals. This is the current estimate. That is eligible patients for AD-DMT in 3 years' time will grow to approximately 100,000 in the United States. And if minimally invasive new screening and diagnostic technology such as blood-based biomarkers could further advance going forward, and therefore, this -- the population -- eligible population is expected to increase gradually over mid to long term. And I would like to give some supplemental explanations by referring to the slide. So this -- the largest circle graph indicates the prevalence of early AD, including the potential early AD patients. And from here, again, the patients would need to seek for the medical attentions and have to be diagnosed with early AD. And therefore, in this process, the potential patients in the Circle 1 would need to be motivated to seek for the medical attentions and also would have to be diagnosed. So when they go to the medical institutions and should be diagnosed with early AD and then comes the amyloid beta testing. So the amyloid beta positivity needs to be confirmed in the patients. So when you go to the #3 on the right-hand side of the slide, currently, amyloid beta testing is done either by PET or CSF. And both in the United States as well as in Japan, I think that the situation is quite similar. That is to say that when it comes to these indications approved for these testing or whether these testings are reimbursable by the insurance or not, and currently, we are faced with rather inadequate situations. And therefore, now that we have new treatment available, and based upon that, this insurance coverage and reimbursement situations for the amyloid beta testing is something that should be further improved. And that is something that we are expecting for. And of course, you can do the testing by CSF. But this requires the lumbar puncture, you need the needle, the shot on the spine, and this would require some technical training. And so amyloid beta testing certainly is accompanied by many different challenges, but I'm expecting the rapid improvement on all of these fronts. But at the same time, as indicated at the bottom, the cheap and convenient blood-based biomarkers are currently under development. And Japanese manufacturers indeed have a very high level of technologies in this field. So it needs to be inexpensive. It needs to be very convenient for this kind of testing. And should this be made available in the clinical practice by around 2025, we are hopeful that those biomarkers would be rendered available for the clinicians. So from the amyloid beta testing and then there will be a significant increase in the number of patients who could be indicated for the AD-DMT kind of treatment. So when the amyloid beta positivity is confirmed in the Stage 4 and then goes into this treatment Phase #5. But there again, between the physician in charge and family members and patients together and there needs to be the close communications and then finally move into the treatment. Quite often, what happens is that this population in the -- prevalent population in #1, is multiplied by proposed price and the enormous amount of the sales revenue projection would be discussed. However, this is quite misleading. So when it comes to the revenue projection for the AD-DMT, include lecanemab, would have to be based upon the population in #5, which is much smaller than the population you can see in #1, which should be multiplied by the proposed price, and that's something that I hope that people would better understand. So based upon the population in #5 and then sales projection -- potential -- the sales projection for AD-DMT would not be the kind of enormous burden for the health care treasury of health care funding of different countries. That's what we think. And going back to the text, published findings in the peer-reviewed journal from the confirmatory Phase III Clarity AD in early AD demonstrate and this is -- I'm talking about the New England Journal of Medicine, which is, of course, the very top-notched world-renowned journal. And that demonstrate that LEQEMBI treatment resulted in less decline measures of cognition and function than placebo at 18 months. That is to say the primary endpoint, at 18 months of CDR-SB, we saw the 27% of the slowing of decline, whereas, when it comes to adverse events profile was pretty much within our expectation. So this, the result of the study were quite consistent with the late Phase II trial that is Study 201 which was the basis for the FDA's Accelerated Approval. And now we are making the advancement in the traditional proof of submission for FDA. Now LEQEMBI's clinical data show that it can help patients remain cognitive, the functions and the preserve activity still living and maintain function abilities much longer, and therefore, could potentially translate into impactful benefit for the patients and their families. And based upon the patient background and findings from the clinical studies, in order to project the trajectory of cognitive decline of the individual AD patients, the disease model, i.e., AD Archimedes condition event simulation, AD ACE model was used in the simulation study. And with this, we assess the lifelong care value and potential economic effect for early AD patients brought about by the LEQEMBI treatment. Now with regard to AD ACE model, and this may not be quite widely known model but the outcome of this study has already been carried in the peer reviewed journal. And also, we saw the very consistent result with the update of the data from the Clarity AD data. So traditionally, the Markov model would quite often be used for this kind of modeling. But compared to that, for this model, the patient individual background, that will be entered into this model so that the patient trajectory for the individual patient can be projected. So data entry is indeed the big enormous work. However, when you think about the patient heterogeneity, and this is a model that can more accurately reflect the patient background to come up with more accurate projections. And this, I think, is the great advantage of this model of AD ACE. And based upon that, in the United States, the societal value of LEQEMBI in the United States is now estimated at $37,600 per year. So LEQEMBI treatment is projected to delay the disease progression, resulting in an increase in the patient's expected time in early AD while reducing the time in more advanced severe states. The slowing of clinical decline on treatment is estimated to delay the disease progression by nearly 3 years on average compared to the standard of care. So delay of the progression mainly from MCI to mild AD, or in the case of the mild AD patients, the progression to moderate AD. And this kind of progression phases can be delayed by as many as 3 years compared to SoC. So LEQEMBI's impact on the disease trajectory is then modeled into annual per patient value, the current value to U.S. society. Based upon the following components, actually, there are 4 components: a, is quality adjusted life years, quality gains. So this is the index used in the HTA, the Health Technology Assessment, quality adjusted life years gain is evaluated compared to SoC. Another factor is willing to pay. The willingness-to-pay threshold, WTP threshold, which I would like to dwell upon later on. C is the cost offset compared to SoC. And D is time on treatment. So these 4 factors would be used to drive this annual per patient value. And they're all discounted into the present value term. And this is the formula. So annual per patient value. You have to look at the quality gained times the WTP threshold plus cost offset and then divided by time on treatment. So this would give the annual per patient value. Again, this is -- I know this is kind of complicated, but I would like to use some actual numbers to explain this further. A, quality. So this is a health outcome value index. So health is the function of length of life that you can enjoy and the quality of life. And this measure combines both attributes into 1 single index with 1 quality gain represents 1 additional year of a persist life at perfect health. So based upon this model analysis, with LEQEMBI's treatment, it is predicted to offer an additional 0.6 for quality compared to SoC for an early AD patients over lifetime by improving outcomes for both patients and caregivers. So from the start of the treatment throughout the life, the total, the quality should be about 4 generally. However, with lecanemab treatment, we expect to increase by 0.64 quality. Actually, this is quite a significant health outcome improvement. At least that's how we look at this. And B is willing-to-pay threshold. So this is more or less a simplistic concept. So when you achieve this full 1 year of perfect health, how much are you willing to pay? This is the amount that is being indicated here. And usually, and conventionally, the WTP structure is based upon 1 to 3x of the country's GDP. And so in the United States, WTP's threshold of $50,000 to $100,000 to $150,000 would be referenced as the cost effectiveness ratio. But for the gravity of conditions with greater burden and interventions that exhibit wider societal benefits such as AD, then much higher WTP of $200,000 of WTP threshold per quality gain is used in the United States. Now cost offset, total cost offset. So we have to really look at both direct and indirect cost and make the comparison between SoC and LEQEMBI. So direct cost include the direct -- the medical cost as well as the indirect cost that will be the cost incurred for the family members. So the direct costs contain cost of medications, the medical visits, hospitalization, living accommodations and community service for the patients. Indirect costs of caregivers, consider the monetary value for our spend on caregiving care activities. And you make the comparison between LEQEMBI and the standard of care with LEQEMBI, you can save as much as $7,415, with the treatment of LEQEMBI. And the fourth factor. So the time on treatment, LEQEMBI is modeled to be stopped upon transition to moderate AD or worse. So with the current discounted values, it amounts to 3.6 years. So going back to the formula. So A is 0.64, quality gained; and the threshold is $200,000 per quality gain; cost offset, $7,415, so they all show the current values. And then yearly, per patient value of LEQEMBI from a societal perspective was quantified at $37,600. So $37,600 of yearly values. Now we have to also look at the lifetime value, so this numerator, so 0.64 times the $200,000 plus $7,415 that is $135,400 would be lifetime valued. Alzheimer's Association also came up with the projection. And actually, it just so happened that they came up with the -- almost the same number as the lifelong value. So LEQEMBI's treatment amongst the early AD patients is now expected to continue for about 10 years, and we expect the number of indicated patients to further increase over 10 years. And then this clinical value in delaying the disease progression and projected social value that help improve patients and caregivers quality of life and productivity plus simulated economic value that help reduce the demand for health services. When we take them all together, we believe that LEQEMBI would generate the positive impact to our society was several tens of billions of dollars, at least it should have that much of a potential. That's what we believe. So I'm talking about the yearly value. But then comes the business pricing, the launch price for LEQEMBI, which is now set at $26,500. While we estimate the per patient per year value of the LEQEMBI treatment to the U.S. society to be $37,600, Eisai decided to price LEQEMBI below qualified societal value at wholesale acquisition cost, the so-called WAC, of $26,500 per year. Based on Study 201 Clarity AD, estimated annual price is based on 10-milligram per kilogram IV biweekly for average years patient weight of 75-kilogram aiming to promote broader patient access, reduce overall financial burden and support health system sustainability. As such, the WAC for 200-milligram vial is $254.81 and the WAC for 500-milligram vial is $637.02. Actual annualized pricing may vary by patient because of different body type. In addition, Eisai continues to pursue less frequent maintenance dosing regimen for LEQEMBI such as monthly instead of current biweekly regimen upon significant amyloid beta clearance to prevent a re-accumulation of amyloid beta biomarkers while maintaining clinical efficacy. This could further lower the yearly cost of LEQEMBI during the maintenance dose phase. If it's monthly maintenance regimen, the cost would be reduced by around half. So this could further lower the yearly cost from $26,500 to potentially about half of the figure given less amount of drugs. Next, I'd like to talk about patient affordability. When the price is set at $26,500, what is going to be a patient affordability? Eisai believes patient affordability must be a key consideration to promote patient access and intended use and benefits of LEQEMBI. Innovation and access is the rule of the modern pharmaceutical companies. We have to achieve innovations. We have to ensure access. There is a major important role to be played by us. Among the eligible early AD patient population in the United States, once the patient's insurer covers LEQEMBI, we estimate that approximately 91% of individual will be covered by Medicare with Medigap, supplementary insurance; Medicare Advantage, Medicare-approved clients from private companies, with potential supplemental coverage where Medicaid managed by States and commercial private insurance. For these patients, the out-of-pocket costs for LEQEMBI treatment could range from 0 to a few dollars per day. Remaining 9% of the individuals will fall into the category of Medicare beneficiaries without supplemental insurance and hence, will be responsible for 20% of LEQEMBI cost as co-insurance under Medicare Part B. For these patients, the estimated out-of-pocket costs for LEQEMBI will translate into about $14.5 per day. Across the entire eligible early AD patient population, we estimate the weighted average out-of-pocket cost for LEQEMBI to be about $2 per day. We will implement initiatives to enhance patient access. Eisai is committed to ensuring that certain financially disadvantaged patients have access to the LEQEMBI. Firstly, Eisai is establishing a patient assistance program, which will provide LEQEMBI at no cost for eligible uninsured and underinsured patients, including Medicare beneficiaries who meet financial need and other program criteria. Among the 9% of the patients I mentioned earlier, I believe there will be some who will be eligible for this program. Secondly, Eisai will offer patient support for improving access through LEQEMBI patient navigators who will provide information about accessing LEQEMBI, helping patients and their families understand their insurance coverage and options, and identifying financial support programs for eligible patients. We provide meticulous support to enhance their access. I'd like to use a material, too, to give you a supplementary explanation. This is the Eisai patient support with this logo. We will provide a meticulous support for the patients under this program. On the left, you see the patient assistance program. We will provide LEQEMBI for eligible uninsured and underinsured patients, including Medicare beneficiaries who meet financial need and other programs criteria at no cost. 9% of the patients will pay a 20% of the cost. Some of them will be eligible for this program. We can provide LEQEMBI at no cost for them. So the average out-of-pocket cost by patients could possibly be reduced further. On the right, LEQEMBI patient navigator is explained. Each patient will have a patient navigator as a point of contact geographically assigned to them. We provide a variety of information and extend swift support. We provide information on insurance coverage, identify financial support programs for eligible patients, and provide information on new insurance options through the LEQEMBI patient navigator to enhance patient access further. I would like to go back to the statement once again. Next, about Health System Sustainability. We believe our pricing approach for LEQEMBI would also help improve health system sustainability which is projected based on appropriate use of LEQEMBI in eligible patients with early AD to improve patients' health outcomes and quality of life, reduce demand for health services, and global burden of disease through changing disease trajectory because we can expect the slowing of the disease progression. We can curtail the spending for the health system to enhance its sustainability. Furthermore, we believe our pricing approach for LEQEMBI, coupled with the size of the targeted patient population, will be sustainable under historical growth and spending assumptions for Medicare Part B. AD-DMT, including LEQEMBI sales forecast, will not apply a big pressure on to the countries or health finances. Last but not the least, giving back more than half of LEQEMBI value to U.S. society. As I mentioned, the price of LEQEMBI at the yearly cost of $26,500 is -- compared to the projected society value of $37,600 is going to be $11,100 lower, and less frequent maintenance dosing regimen will further lower the yearly cost of LEQEMBI well below the projected society value over time. With the time span of 10 years from now, taking these savings as well as discounts and rebates within the U.S. health care system into consideration over 10 years' time span cumulatively, the gradual adoption of LEQEMBI treatment at this pricing approach could give back about 60% of the potential positive of social impact of several tens of billion dollars to the U.S. society. About 60% of the potential positive societal impact of several tens of billion dollars will be given back to the U.S. society. These resources could help realizing new innovation that enhance the health and quality of life for individuals at risk of developing AD or those living with AD as well as their families and caregivers. On the other hand, less than half or about 40% of potential positive societal impact of several tens of billion dollars will be accrued by employees and shareholders in the form of product sales from which we are committed to reinvest in future research and development to create new AD therapies, new innovations such as establishing ecosystems toward inclusive AD communities. We deeply believe that our pricing approach to maximize value for all stakeholders will help Eisai achieve social good in the form of relieving anxiety over health and reducing health disparity according to our corporate philosophy. I'd like to use material 3 to talk about the social impact, giving back 60% to society and 40% to be accrued by employees and shareholders. Today, I gave you a variety of numbers. So where each number is applied is going to be briefly explained for your better understanding. Please look at the pink box. Social impact, several tens of billion dollars, how did we calculate the figure? This is very simple. On the upper left, you see annual society value per patient, $37,600 multiplied by the number of patients treated with LEQEMBI. I cannot say the actual figure for the number of patients treated with LEQEMBI. This calculation would lead to several tens of billion dollars. 60% will be given back to the U.S. society and 40% will be accrued in the form of product sales, not profit, by employees and shareholders with a 60-40 ratio -- percent ratio, we'd like to allocate this amount to these stakeholders. And we have calculated the annual net price per patient. As I explained earlier, there's going to be the initiation or the introduction of the maintenance dosing. So the amount of dosings, the annual net price will decrease over time. And what is the launch price, that's before rebate deductions. We give rebate amounts to the government, so the net price is after rebate deductions. And we have $26,500. And then the annual net price, so the annual net price is going to be lower over years. $37,600, we have the lifetime value of $135,000 divided by time on treatment of 3.6 years divided by the annual net price per patient multiplied by the number of patients treated with LEQEMBI, whose number cannot be disclosed right now, multiplied by annual net price is the social impact of several tens of billion dollars, which is going to be allocated 60% to the U.S. society and 40% to the employees and the shareholders. That is going to be the society value creation and giving back to society through LEQEMBI. This $26,500 is the U.S. LEQEMBI price. In other regions and countries, there are respective health systems and pricing rules, so there's going to be pricing according to those rules. And with this, I'd like to finish my presentation. Thank you very much for your attention.

Next, we'd like to move into the Q&A session. So first, we'd like to entertain the questions from those people in this room. And then one by one, we'd like to receive the questions from those people connected online. So those who want to raise questions in this room, please raise your hand, then we're going to bring the microphone, please state your name and affiliations. And because of the time limitations, please ask only one question per person. We will let everybody ask questions.

I'm Muraoka from Morgan Stanley. Congratulations for the approval with a very clear label. Since I can ask only 1 question, so I would like to discuss the pricing to come in the future, perhaps in 1 year time after launch. So once the subcu, subcutaneous formulation that you're currently developing. And I think it's probably like a 10-milligram weekly dosing would be most likely?

So once the subcu formulation comes into the market, $26,500 with a simple calculation, it's going to double the cost. But even with the SC formulation laws, it is correct to understand that yearly cost would remain unchanged, so the yearly cost would never go above $26,500. The net price going forward is expected to decline, including SC formulation. That's what we think. Thank you.

Thank you very much. Next person. The person in the second row from the window side.

[indiscernible] from NHK. I have a question to CEO Naito. The launch price in the United States for Eisai, do you think that you kept the price at a low level? As you explained from our CEO, what's your perception? And what do you feel about this pricing level?

For the past 20 years or so, value-based pricing concept in the pricing of pharmaceutical, I think this is the basics in my view. The value is not just the medical value, but social value as well as other values to evaluate the value of pharmaceuticals in my view. In U.K., there is NICE. For Health Technology Assessment, it was one of the early phase of HTA, we communicated with NICE as well. But when it comes to value-based pricing, by regulators as a rationale for pricing, it's not broadly utilized yet. For LEQEMBI value-based pricing, we think, should be questioned to society. But value-based pricing suggest, it's not the pricing for $37,650 (sic) [ $37,600 ]. More than half or 60% of the value is to be returned and given back to society. And the remaining 40% would be accrued by employees and shareholders, which also important stakeholders in our view. So we are going to allocate the amount to these groups through this allocation. That's why we calculate it early price of $26,500.

Using value-based pricing as a basic, we considered giving back to society in this pricing for LEQEMBI. When you consider giving back to society in the pricing, what do you mean by that in simple terms?

Payers and the government, there are rebates and others to be given back to them. At the same time, for patients and their family members, as I said today, medical, clinical value, economic value and social value in this AD ACE model, are all taken into account in this $37,600. And the part of this 60% is to be given back to society.

Second row.

My name is [ Takimoto ], Economic Department of Kyoto. Congratulations for today. Now you talked about the return and giving back to the society. But having said that, in the United States, not limited to U.S., but also in Japan as well as in Europe, I think that you probably have a very good positive prospect for the coming approach. And in view of that, at this point in time, what is your view of the impact that would have on your -- the economic top line of your company and business performance, together with the -- at home?

So we expect that in 3 years' time, the expected number of patients will be like 100,000, and for the total AD-DMT out of which, how much of the share that LEQEMBI can achieve is, of course, something that we don't know. But at least in the United States in 3 years' time, the estimate is that the patient population will grow to 100,000. And in 2030, as is indicated in the Circle #5, and it is estimated that 2.5 million, the patients would fall into this population as designated in #5. And this is the global numbers. So of course, China and India, all these big Asian countries. So let's say, the blood-based biomarkers may be rendered for the clinical practice, that is the basic assumption here. But by the 2025, the population designated in #5 would grow to like 2.5 billion. That's sort of our current projection. Of course, I cannot share with you any further details. And of course, at the time of the yearly financial, the meeting then, I would like to explain more in detail.

Just your sentiments of your expectations, how much of the impact are you expecting this to generate for your company's performance?

Of course, immediately post launch -- of course, you cannot really expect a rapid increase in the profit, the bottom line. However, from the second half of second year and the third year, I expect this product to contribute to bottom line. And after that, we expect it to have a very positive contribution to our business performance.

Next person. The person in the third row, please.

Eguchi from Asahi Shimbun newspaper. Regarding the procedures, in the United States, you already filed your submission for traditional approval on the same day of accelerated approval. But in areas or countries other than United States, anything you can disclose today? For example, in Japan, what is going to be the pace to realize the -- putting this to the practical use in Japan? I don't know whether you can talk about the pricing in Japan, but if there is anything you can explain, I'd like to hear.

Regarding the approval of timing, Nakahama is going to respond. I'm going to comment on the pricing a bit. Nakahama, in charge of regulatory affairs in Japan.

Thank you for your question. As for the filing in Japan, after the full approval of filing in the United States, we would like to aim for filing in Japan as soon as possible. Since March last year, using the preliminary pharmaceutical assessment system with PMDA, PMDA has kindly started a review of some of the data. As for the approval timing, it's up to the regulatory authorities, but we would like to aim for approval to be obtained by the end of this year. So that's my response to the timing of approval.

As for the pricing, today, we are talking about the pricing in the United States. With regards to the pricing in Japan, the drug calculation system, there is a totally different system. In principle, in line with that NHI drug pricing system, with regulatory authorities and the government, we'd like to discuss with them.

But this is an innovation originating from Japan.

As I said, also to Japanese society, there is going to be a huge societal impact in Japan as well. Value base or value creation is the concept. We are hoping to discuss. That's our wish. So we're hoping to have lots of discussions. In Japan, there is good pricing system. We understand that that's the basic principle we should follow. It's independent from the U.S. pricing to determine the pricing in Japan.

Next person.

[ Takei ] from [indiscernible] newspaper. So as was discussed before, there was the question about the submission timing in Japan. But as of today, according to your press materials, you're aiming at the submission before the end of this year. But once again, I would like to ask Mr. Naito to speak on this. Are you also agreeing on the submission before the end of the year? Or do you have any more specific ideas like before the end of February?

Once again, I would like to repeat the same questions. Ms. Nakahama has already said that she would like to aim at submission as early as possible. That's very important. Every day, it matters. And so with that much of the sense of desperation that we are working on the early submission as much as possible. I hope you will understand and accept response as such.

Well, would it be possible that you may be able to file before the end of this month? Would it be totally out of picture for you to submit this month as early as possible?

So I don't know how far away from the actual -- the goal that we have. But -- so you can look me in my eyes and thank you.

Next question. The person in the second row.

[indiscernible], nonfiction writer. This is something you expected, but still congratulations. Just one question I can ask, right? So good news and bad news. On Saturday morning comes, as you said before. This time, at around what time do you come to know about the approval? Did you see the EPC to see the display of the approval information by FDA? Or where were you when you got the news? And how did you feel? I'd like to know more details about that particular scene.

Can I explain? Well, there was a telephone call at around 3:30, close to 4:00 in the morning from Ivan Cheung. I was sleeping, but I knew there can be a telephone call, so I responded to the call immediately, and there was a mention of the congratulations. There was 1 teardrop coming out of my eyes. Usually, I don't shed tears. But there was 1 drop of tear from my left eye.

So did you have a smartphone or mobile phone at your bedside?

Yes.

Great.

Next person.

Congratulations. You mentioned that the different countries do have different pricing systems and also in Japan, Japan has its own drug pricing system, which you would follow. And of course, you talked about the importance of looking into the societal value. But in Japan, as you move into the process of pricing of this product, the kind of approach that you have introduced in the United States at least 60% of the societal value can be returned back to the societies. Do you think that kind of concept can also be possibly be reflected into the pricing in Japan?

Well, first of all, so this kind of pricing approach, when you want to try to apply this to the Japanese society, and you look at the annual values to be estimated, as soon as possible internally at Eisai, we have to study this. And then comes the negotiation with the regulatory authorities. Of course, we want to bring those ideas on the table, but to what extent they are going to reflect that into the actual pricing? That's something I don't know. It's pretty much up to this -- the concept of the regulatory and pricing authority. At least, I would like to give it a try to make that kind of a challenge. But to what extent we can reach an agreement is something I really have no idea about right now.

Next person in the second row -- rather in the first row.

[indiscernible]. Congratulations. Compared to the actual price, you set the launch price by $11,000. Could you elaborate on the rationale for the pricing?